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Giuseppe BORIANI

Professore Ordinario
Dipartimento di Scienze Biomediche, Metaboliche e Neuroscienze sede Policlinico

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Pubblicazioni

2024 - Asymptomatic vs. symptomatic atrial fibrillation: Clinical outcomes in heart failure patients [Articolo su rivista]
Boriani, G.; Bonini, N.; Vitolo, M.; Mei, D. A.; Imberti, J. F.; Gerra, L.; Romiti, G. F.; Corica, B.; Proietti, M.; Diemberger, I.; Dan, G. -A.; Potpara, T.; Lip, G. Y.
abstract

Background: The outcome implications of asymptomatic vs. symptomatic atrial fibrillation (AF) in specific groups of patients according to clinical heart failure (HF) and left ventricular ejection fraction (LVEF) need to be clarified. Methods: In a prospective observational study, patients were categorized according to overt HF with LVEF≤40 %, or with LVEF>40 %, or without overt HF with LVEF40 %≤ or > 40 %, as well as according to the presence of asymptomatic or symptomatic AF. Results: A total of 8096 patients, divided into 8 groups according to HF and LVEF, were included with similar proportions of asymptomatic AF (ranging from 43 to 48 %). After a median follow-up of 730 [699 -748] days, the composite outcome (all-cause death and MACE) was significantly worse for patients with asymptomatic AF associated with HF and reduced LVEF vs. symptomatic AF patients of the same group (p = 0.004). On adjusted Cox regression analysis, asymptomatic AF patients with HF and reduced LVEF were independently associated with a higher risk for the composite outcome (aHR 1.32, 95 % CI 1.04-1.69) and all-cause death (aHR 1.33, 95 % CI 1.02-1.73) compared to symptomatic AF patients with HF and reduced LVEF. Kaplan-Meier curves showed that HF-LVEF≤40 % asymptomatic patients had the highest cumulative incidence of all-cause death and MACE (p < 0.001 for both). Conclusions: In a large European cohort of AF patients, the risk of the composite outcome at 2 years was not different between asymptomatic and symptomatic AF in the whole cohort but adverse implications for poor outcomes were found for asymptomatic AF in HF with LVEF≤40 %.

2024 - Atrial fibrillation before and after transcatheter aortic valve implantation: short- and long-term clinical implications [Articolo su rivista]
Arrotti, Salvatore; Sgura, Fabio Alfredo; Leo, Giulio; Vitolo, Marco; Monopoli, Daniel; Forzati, Nicola; Siena, Valerio; Menozzi, Matteo; Cataldo, Paolo; Stuani, Marco; Morgante, Vernizia; Magnavacchi, Paolo; Gabbieri, Davide; Guiducci, Vincenzo; Benatti, Giorgio; Vignali, Luigi; Rossi, Rosario; Boriani, Giuseppe
abstract

BackgroundPatients with atrial fibrillation (AF) undergoing transcatheter aortic valve implantation (TAVI) have been associated with worse short-term outcomes compared with patients in sinus rhythm but data on long-term outcomes are limited. The aim of our study was to evaluate the association between AF and short- and long-term outcomes in patients undergoing TAVI.MethodsWe retrospectively evaluated patients undergoing TAVI between 2012 and 2022 in four tertiary centres. Two different analyses were conducted: (i) in-hospital and (ii) postdischarge analysis. First, we evaluated the association between preexisting AF and short-term outcomes according to VARC-3 criteria. Second, we analyzed the association between AF at discharge (defined as both preexisting and new-onset AF occurring after TAVI) and long-term outcomes at median follow-up of 3.2 years (i.e. all-cause death, hospitalization and major adverse cardiovascular events).ResultsA total of 759 patients were initially categorized according to the presence of preexisting AF (241 vs. 518 patients). The preexisting AF group had a higher occurrence of acute kidney injury [odds ratio (OR) 1.65; 95%confidence interval ( CI) 1.15-2.38] and major bleeding (OR 1.86, 95% CI 1.06-3.27). Subsequently, the population was categorized according to the presence of AF at discharge. At the adjusted Cox regression analysis, AF was independently associated with an increased risk of all-cause death and cardiovascular hospitalization [adjusted hazard ratio (aHR) 1.42, 95% CI 1.09-1.86], all-cause death and all-cause hospitalization (aHR 1.38, 95% CI 1.06-1.78) and all-cause hospitalization (aHR 1.59, 95% CI 1.14.2.22).ConclusionsIn a real-world cohort of patients undergoing TAVI, the presence of AF (preexisting and new-onset) was independently associated with both short- and long-term adverse outcomes.

2024 - The key role of public health in renovating Italian biomedical doctoral programs [Articolo su rivista]
Palandri, Lucia; Urbano, Teresa; Pezzuoli, Carla; Miselli, Francesca; Caraffi, Riccardo; Filippini, Tommaso; Bargellini, Annalisa; Righi, Elena; Mazzi, Davide; Vigezzi, Giacomo Pietro; Odone, Anna; Marmiroli, Sandra; Boriani, Giuseppe; Vinceti, Marco
abstract

Background: A key renovation of doctoral programs is currently ongoing in Italy. Public health and its competencies may play a pivotal role in high-level training to scientific research, including interdisciplinary and methodological abilities. Methods: As a case study, we used the ongoing renovation of the Clinical and Experimental Medicine doctoral program at the University of Modena and Reggio Emilia. We focused on how the program is designed to meet national requirements as well as students' needs, thus improving educational standards for scientific research in the biomedical field, and on the specific contribution of public health and epidemiology in such an effort. Results: The renovation process of doctoral programs in Italy, with specific reference to the biomedical field, focuses on epidemiologic-statistical methodology, ethics, language and communication skills, and open science from an interdisciplinary and international perspective. In the specific context of the doctoral program assessed in the study and from a broader perspective, public health appears to play a key role, taking advantage of most recent methodological advancements, and contributing to the renovation of the learning process and its systematic quality monitoring. Conclusions: From a comparative assessment of this case study and Italian legislation, the key role of public health has emerged in the renovation process of doctoral programs in the biomedical field.

2024 - Validating the predictive ability of the 2MACE score for major adverse cardiovascular events in patients with atrial fibrillation: results from phase II/III of the GLORIA-AF registry [Articolo su rivista]
Ding, W. Y.; Fawzy, A. M.; Romiti, G. F.; Proietti, M.; Pastori, D.; Huisman, M. V.; Lip, G. Y. H.; Abban, D. W.; Abdul, N.; Abud, A. M.; Adams, F.; Addala, S.; Adragão, P.; Ageno, W.; Aggarwal, R.; Agosti, S.; Agostoni, P.; Aguilar, F.; Linares, J. A.; Aguinaga, L.; Ahmed, J.; Aiello, A.; Ainsworth, P.; Aiub, J. R.; Al-Dallow, R.; Alderson, L.; Velasco, J. A. A.; Alexopoulos, D.; Manterola, F. A.; Aliyar, P.; Alonso, D.; da Costa, F. A. A.; Amado, J.; Amara, W.; Amelot, M.; Amjadi, N.; Ammirati, F.; Andrade, M.; Andrawis, N.; Annoni, G.; Ansalone, G.; Ariani, M. K.; Arias, J. C.; Armero, S.; Arora, C.; Aslam, M. S.; Asselman, M.; Audouin, P.; Augenbraun, C.; Aydin, S.; Ayryanova, I.; Aziz, E.; Backes, L. M.; Badings, E.; Bagni, E.; Baker, S. H.; Bala, R.; Baldi, A.; Bando, S.; Banerjee, S.; Bank, A.; Esquivias, G. B.; Barr, C.; Bartlett, M.; Kes, V. B.; Baula, G.; Behrens, S.; Bell, A.; Benedetti, R.; Mazuecos, J. B.; Benhalima, B.; Bergler-Klein, J.; Berneau, J. B.; Berrospi, P.; Berti, S.; Berz, A.; Best, E.; Bettencourt, P.; Betzu, R.; Bhagwat, R.; Bhatta, L.; Biscione, F.; Bisignani, G.; Black, T.; Bloch, M. J.; Bloom, S.; Blumberg, E.; Bo, M.; Bøhmer, E.; Bollmann, A.; Bongiorni, M. G.; Boriani, G.; Boswijk, D. J.; Bott, J.; Bottacchi, E.; Kalan, M. B.; Bradman, D.; Brautigam, D.; Breton, N.; Brouwers, P. J. A. M.
abstract

The 2MACE score was specifically developed as a risk-stratification tool in atrial fibrillation (AF) to predict cardiovascular outcomes. We evaluated the predictive ability of the 2MACE score in the GLORIA-AF registry. All eligible patients from phase II/III of the prospective global GLORIA-AF registry were included. Major adverse cardiac events (MACEs) were defined as the composite outcome of stroke, myocardial infarction and cardiovascular death. Cox proportional hazards were used to examine the relationship between the 2MACE score and study outcomes. Predictive capability of the 2MACE score was investigated using receiver-operating characteristic curves. A total of 25,696 patients were included (mean age 71 years, female 44.9%). Over 3 years, 1583 MACEs were recorded. Patients who had MACE were older, with more cardiovascular risk factors and were less likely to be managed using a rhythm-control strategy. The median 2MACE score in the MACE and non-MACE groups were 2 (IQR 1-3) and 1 (IQR 0-2), respectively (p < 0.001). The 2MACE score was positively associated with an increase in the risk of MACE, with a score of & GE; 2 providing the best combination of sensitivity (69.6%) and specificity (51.6%), HR 2.47 (95% CI, 2.21-2.77). The 2MACE score had modest predictive performance for MACE in patients with AF (AUC 0.655 (95% CI, 0.641-0.669)). Our analysis in this prospective global registry demonstrates that the 2MACE score can adequately predict the risk of MACE (defined as myocardial infarction, CV death and stroke) in patients with AF. Clinical trial registration:. Unique identifiers: NCT01468701, NCT01671007 and NCT01937377

2023 - 2020 Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing [Articolo su rivista]
Stabile, G.; Guerra, F.; Tola, G.; Vergara, P.; Accogli, M.; Bertini, M.; Bisignani, G.; Forleo, G. B.; Lavalle, C.; Notarstefano, P.; Zanotto, G.; Landolina, M.; Boriani, G.; Ricci, R. P.; D'Onofrio, A.; De Ponti, R.
abstract

Background. This report describes the findings of the 2020 Italian Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC). Methods. Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers. Results. A total of 10 378 ablation procedures were performed by 66 institutions. Most centers (70%) have an electrophysiology laboratory, and 23% a hybrid cardiac surgery laboratory. All centers have a 3D mapping system. The median number of electrophysiologists and nurses involved in the electrophysiology laboratory was 3.5 and 3, respectively. An electrophysiology technician was involved in 35% of all centers. In 88.2% of cases, catheter ablation was performed for supraventricular arrhythmias; the most frequently treated arrhythmia was atrial fibrillation (39.4%), followed by atrioventricular nodal reentrant tachycardia (18.6%), and common atrial flutter (10.6%). In 72.9% of patients, catheter ablation was performed using a 3D mapping system, with a “near-zero” fluoroscopic approach in 37.7% of all patients. Conclusions. The 2020 Italian Catheter Ablation Registry confirmed that the electrophysiology activity was markedly affected by the COVID-19 pandemic; atrial fibrillation is the most frequently treated arrhythmia with an increasing number of procedures performed with a 3D mapping system and a “near-zero” approach.

2023 - A systematic review and meta-analysis on oncological radiotherapy in patients with a cardiac implantable electronic device: Prevalence and predictors of device malfunction in 3121 patients [Articolo su rivista]
Malavasi, V. L.; Imberti, J. F.; Tosetti, A.; Romiti, G.; Vitolo, M.; Zecchin, M.; Mazzeo, E.; Giuseppina, D. M.; Lohr, F.; Lopez-Fernandez, T.; Boriani, G.
abstract

Background: The number of patients with cardiac implantable electronic devices (CIEDs) undergoing radiotherapy (RT) for cancer treatment is growing. At present, prevalence and predictors of RT-induced CIEDs malfunctions are not defined. Methods: Systematic review and meta-analysis conducted following the PRISMA recommendations. PubMed, Scopus and Google Scholar were searched from inception to 31/01/2022 for studies reporting RT-induced malfunctions in CIEDs patients. Aim was to assess the prevalence of RT-induced CIEDs malfunctions and identify potential predictors. Results: Thirty-two out of 3962 records matched the inclusion criteria and were included in the meta-analysis. A total of 135 CIEDs malfunctions were detected among 3121 patients (6.6%, 95% confidence interval [CI]: 5.1%–8.4%). The pooled prevalence increased moving from pacemaker (PM) to implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy and defibrillator (CRT-D) groups (4.1%, 95% CI: 2.9–5.8; 8.2% 95% CI: 5.9–11.3; and 19.8%, 95% CI: 11.4–32.2 respectively). A higher risk ratio (RR) of malfunctions was found when neutron-producing energies were used as compared to non-neutron-producing energies (RR 9.98, 95% CI: 5.09–19.60) and in patients with ICD/CRT-D as compared to patients with PM/CRT-P (RR 2.07, 95% CI: 1.40–3.06). On the contrary, no association was found between maximal radiation dose at CIED >2 Gy and CIEDs malfunctions (RR 0.93; 95% CI: 0.31–2.76). Conclusions: Radiotherapy related CIEDs malfunction had a prevalence ranging from 4% to 20%. The use of neutron-producing energies and more complex devices (ICD/CRT-D) were associated with higher risk of device malfunction, while the radiation dose at CIED did not significantly impact on the risk unless higher doses (>10 Gy) were used.

2023 - Adherence to the Atrial Fibrillation Better Care (ABC) pathway and the risk of major outcomes in patients with atrial fibrillation: A post-hoc analysis from the prospective GLORIA-AF Registry [Articolo su rivista]
Romiti, G. F.; Proietti, M.; Bonini, N.; Ding, W. Y.; Boriani, G.; Huisman, M. V.; Lip, G. Y. H.
abstract

Background: The ‘Atrial fibrillation Better Care’ (ABC) pathway has been proposed to streamline a more holistic or integrated care approach to atrial fibrillation (AF) management. We aimed to analyse the impact of adherence to the ABC pathway on the risk of major adverse outcomes in a contemporary prospective global cohort of patients with AF. Methods: Patients enrolled Phase II and III of the GLORIA-AF Registry with complete data on ABC pathway adherence and follow-up were included in this post-hoc analysis between November 2011 and December 2014 for Phase II, and between January 2014 and December 2016 for Phase III. The primary outcome was the composite of all-cause death and major adverse cardiovascular events (MACEs). Multivariable Cox-regression and delay of event (DoE) analyses were used to evaluate the association between adherence to the ABC pathway and the risk of outcomes. Findings: We included 24,608 patients in this analysis (mean age: 70.2 (10.3) years, 10,938 (44.4%) females). Adherence to the ABC pathway was associated with a significant risk reduction for the primary outcome, with greatest magnitude observed for full ABC pathway adherence (adjusted Hazard Ratio [aHR] 0.54, 95% Confidence Interval [CI]: 0.44–0.67, p < 0.0001). ABC pathway adherence was also associated with reduced risk of mortality (aHR: 0.89, 95% CI: 0.79–1.00, p = 0.048), thromboembolism (aHR: 0.78, 95% CI: 0.65–0.94, p = 0.0078), and MACE (aHR: 0.82, 95% CI: 0.71–0.95, p = 0.0071). An increasing number of ABC criteria attained was associated with longer event-free survival in the DoE analysis. Interpretation: Adherence to the ABC pathway in patients with AF was associated with a reduced risk of major adverse events, including mortality, thromboembolism and MACE. This underlines the importance of using the ABC pathway in the clinical care of patients with AF. Funding: This study was funded by Boehringer Ingelheim.

2023 - Alcohol Intake and Blood Pressure Levels: A Dose-Response Meta-Analysis of Nonexperimental Cohort Studies [Articolo su rivista]
Di Federico, Silvia; Filippini, Tommaso; Whelton, Paul K; Cecchini, Marta; Iamandii, Inga; Boriani, Giuseppe; Vinceti, Marco
abstract

Background: Alcohol consumption may increase blood pressure but the details of the relationship are incomplete, particularly for the association at low levels of alcohol consumption, and no meta-analyses are available for nonexperimental cohort studies. Methods: We performed a systematic search of longitudinal studies in healthy adults that reported on the association between alcohol intake and blood pressure. Our end points were the mean differences over time of systolic (SBP) and diastolic blood pressure (DBP), plotted according to baseline alcohol intake, by using a dose-response 1-stage meta-analytic methodology. Results: Seven studies, with 19 548 participants and a median follow-up of 5.3 years (range, 4-12 years), were included in the analysis. We observed a substantially linear positive association between baseline alcohol intake and changes over time in SBP and DBP, with no suggestion of an exposure-effect threshold. Overall, average SBP was 1.25 and 4.90 mm Hg higher for 12 or 48 grams of daily alcohol consumption, compared with no consumption. The corresponding differences for DBP were 1.14 and 3.10 mm Hg. Subgroup analyses by sex showed an almost linear association between baseline alcohol intake and SBP changes in both men and women, and for DBP in men while in women we identified an inverted U-shaped association. Alcohol consumption was positively associated with blood pressure changes in both Asians and North Americans, apart from DBP in the latter group. Conclusions: Our results suggest the association between alcohol consumption and SBP is direct and linear with no evidence of a threshold for the association, while for DBP the association is modified by sex and geographic location.

2023 - Atrial Fibrillation Ablation in Patients Recently Hospitalized for Worsening Heart Failure: Need for Individualized Decision-Making [Articolo su rivista]
Boriani, G.; Mei, D. A.; Imberti, J. F.
abstract

2023 - Atrial fibrillation and HIV: a new association requiring pathophysiological and outcome studies [Articolo su rivista]
Imberti, Jacopo F; Vitolo, Marco; Boriani, Giuseppe
abstract

2023 - Atrial fibrillation and stroke prevention: 25 years of research at EP Europace journal [Articolo su rivista]
Lip, G. Y. H.; Proietti, M.; Potpara, T.; Mansour, M.; Savelieva, I.; Tse, H. F.; Goette, A.; Camm, A. J.; Blomstrom-Lundqvist, C.; Gupta, D.; Boriani, G.
abstract

Stroke prevention in patients with atrial fibrillation (AF) is one pillar of the management of this common arrhythmia. Substantial advances in the epidemiology and associated pathophysiology underlying AF-related stroke and thrombo-embolism are evident. Furthermore, the introduction of the non-vitamin K antagonist oral anticoagulants (also called direct oral anticoagulants) has clearly changed our approach to stroke prevention in AF, such that the default should be to offer oral anticoagulation for stroke prevention, unless the patient is at low risk. A strategy of early rhythm control is also beneficial in reducing strokes in selected patients with recent onset AF, when compared to rate control. Cardiovascular risk factor management, with optimization of comorbidities and attention to lifestyle factors, and the patient's psychological morbidity are also essential. Finally, in selected patients with absolute contraindications to long-term oral anticoagulation, left atrial appendage occlusion or exclusion may be considered. The aim of this state-of-the-art review article is to provide an overview of the current status of AF-related stroke and prevention strategies. A holistic or integrated care approach to AF management is recommended to minimize the risk of stroke in patients with AF, based on the evidence-based Atrial fibrillation Better Care (ABC) pathway, as follows: A: Avoid stroke with Anticoagulation; B: Better patient-centred, symptom-directed decisions on rate or rhythm control; C: Cardiovascular risk factor and comorbidity optimization, including lifestyle changes.

2023 - Atrial fibrillation in pneumonia: what clinical implications at long-term? [Articolo su rivista]
Vitolo, Marco; Bonini, Niccolò; Imberti, Jacopo F.; Boriani, Giuseppe
abstract

2023 - Atrial fibrillation in vascular surgery: a systematic review and meta-analysis on prevalence, incidence and outcome implications [Articolo su rivista]
Malavasi, V. L.; Muto, F.; Ceresoli, P. A. C. M.; Menozzi, M.; Righelli, I.; Gerra, L.; Vitolo, M.; Imberti, J. F.; Mei, D. A.; Bonini, N.; Gargiulo, M.; Boriani, G.
abstract

Aims: To know the prevalence of atrial fibrillation (AF), as well as the incidence of postoperative AF (POAF) in vascular surgery for arterial diseases and its outcome implications. Methods: We performed a systematic review and meta-analysis following the PRISMA statement. Results: After the selection process, we analyzed 44 records (30 for the prevalence of AF history and 14 for the incidence of POAF). The prevalence of history of AF was 11.5% [95% confidence interval (CI) 1-13.3] with high heterogeneity (I2 = 100%). Prevalence was higher in the case of endovascular procedures. History of AF was associated with a worse outcome in terms of in-hospital death [odds ratio (OR) 3.29; 95% CI 2.66-4.06; P < 0.0001; I2 94%] or stroke (OR 1.61; 95% CI 1.39-1.86; P < 0.0001; I2 91%). The pooled incidence of POAF was 3.6% (95% CI 2-6.4) with high heterogeneity (I2 = 100%). POAF risk was associated with older age (mean difference 4.67 years, 95% CI 2.38-6.96; P = 0.00007). The risk of POAF was lower in patients treated with endovascular procedures as compared with an open surgical procedure (OR 0.35; 95% CI 0.13-0.91; P = 0.03; I2 = 61%). Conclusions: In the setting of vascular surgery for arterial diseases a history of AF is found overall in 11.5% of patients, more frequently in the case of endovascular procedures, and is associated with worse outcomes in terms of short-term mortality and stroke. The incidence of POAF is overall 3.6%, and is lower in patients treated with an endovascular procedure as compared with open surgery procedures. The need for oral anticoagulants for preventing AF-related stroke should be evaluated with randomized clinical trials.

2023 - Atrial fibrillation screening: Great debate on which approach to apply, which tools to use and which population to target [Articolo su rivista]
Boriani, G.; Imberti, J. F.; Vitolo, M.
abstract

2023 - Avoiding unnecessary ventricular pacing is associated with reduced incidence of heart failure hospitalizations and persistent atrial fibrillation in pacemaker patients [Articolo su rivista]
Arnold, M.; Richards, M.; D'Onofrio, A.; Faulknier, B.; Gulizia, M.; Thakur, R.; Sakata, Y.; Lin, W.; Pollastrelli, A.; Grammatico, A.; Auricchio, A.; Boriani, G.
abstract

Aims In bradycardia patients treated with dual-chamber pacing, we aimed to evaluate whether pacing with atrioventricular (AV) delay management [AV hysteresis (AVH)], compared with standard pacing with fixed AV delays, reduces unnecessary ventricular pacing percentage (VPP) and is associated with better clinical outcomes. Main study endpoints were the incidence of heart failure hospitalizations (HFH), persistent atrial fibrillation (AF), and cardiac death. Methods Data from two identical prospective observational studies, BRADYCARE I in the USA and BRADYCARE II in Europe, Africa, and results and Asia, were pooled. Overall, 2592 patients (75 ± 10 years, 45.1% female, 50% with AVH) had complete clinical and device data at 1-year follow-up and were analysed. Primary pacing indication was sinus node disease (SND) in 1177 (45.4%), AV block (AVB) in 974 (37.6%), and other indications in 441 (17.0%) patients. Pacing with AVH, compared with standard pacing, was associated with a lower 1-year incidence of HFH [1.3% vs. 3.1%, relative risk reduction (RRR) 57.5%, P = 0.002] and of persistent AF (5.3% vs. 7.7%, RRR = 31.1%, P = 0.028). Cardiac mortality was not different between groups (1.0% vs. 1.4%, RRR = 27.8%, P = 0.366). Pacing with AVH, compared with standard pacing, was associated with a lower (P < 0.001) median VPP in all patients (7% vs. 75%), in SND (3% vs. 44%), in AVB (25% vs. 98%), and in patients with other pacing indications (3% vs. 47%).Conclusion Cardiac pacing with AV delay management via AVH is associated with reduced 1-year incidence of HFH and persistent AF, most likely due to a reduction in VPP compared to standard pacing.

2023 - Biventricular versus left ventricular only stimulation: an echocardiographic substudy of the B-LEFT HF trial [Articolo su rivista]
Ansalone, G.; Boriani, G.; Sassone, B.; Camastra, G.; Donal, E.; Calo, L.; Casella, M.; Delarche, N.; Lozano, I. F.; Biffi, M.; Boulogne, E.; Guidotto, T.; Leclercq, C.
abstract

BackgroundThe noninferiority of left ventricular pacing alone (LVp) compared with biventricular pacing (BIV) has not been yet definitely documented. In this study, we reviewed all the original echocardiographic measures of the Biventricular versus Left Univentricular Pacing with ICD Back-up in Heart Failure Patients (B-LEFT HF) trial in order to investigate mechanisms underlying LV remodelling with both pacing modalities.MethodsPatients with New York Heart Association functional class (NYHA) III or IV despite optimal medical therapy, LVEF 35% or less, left ventricular end-diastolic diameter (LVEDD) more than 55 mm, QRS duration at least 130 ms were randomized to BIV or LVp for 6 months. The primary end point was a composite of at least 1 point decrease in NYHA class and at least 5 mm decrease in left ventricular end-systolic diameter (LVESD). An additional end point was a LVp reverse remodelling defined as at least 10% decrease in LVESD. Mitral regurgitation and all echocardiographic measures were reassessed after 6-month follow-up.ResultsOne hundred and forty-three patients were enrolled. Seventy-six patients were in the BIV and 67 were in the LVp group. Left ventricular volumes decreased significantly without difference between groups (P = 0.8447). Similarly, left ventricular diameters decreased significantly in both groups with a significant decrease in LVESD with BIV (P < 0.0001), but not with LVp (P = 0.1383). LVEF improved in both groups without difference (P = 0.8072). Mitral regurgitation did not improve either with BIV, or with LVp.ConclusionThe echocardiographic sub-analysis of B-LEFT study showed the substantial equivalence of LVp in favouring left ventricular reverse remodelling as compared with BIV.

2023 - Cardiac Surgery in Jehovah's Witnesses Patients and Association With Peri-Operative Outcomes: A Systematic Review and Meta-Analysis [Articolo su rivista]
Vitolo, M.; Mei, D. A.; Cimato, P.; Bonini, N.; Imberti, J. F.; Cataldo, P.; Menozzi, M.; Filippini, T.; Vinceti, M.; Boriani, G.
abstract

Background: Strategies for blood conservation, coupled with a careful preoperative assessment, may be applied to Jehovah's Witnesses (JW) patients who are candidates for cardiac surgery interventions. There is a need to assess clinical outcomes and safety of bloodless surgery in JW patients undergoing cardiac surgery. Methods: We performed a systematic review and meta-analysis of studies comparing JW patients with controls undergoing cardiac surgery. The primary endpoint was short-term mortality (in-hospital or 30-day mortality). Peri-procedural myocardial infarction, re-exploration for bleeding, pre-and postoperative Hb levels and cardiopulmonary bypass (CPB) time were also analyzed. Results: A total of 10 studies including 2,302 patients were included. The pooled analysis showed no substantial differences in terms of short-term mortality among the two groups (OR 1.13, 95% CI 0.74-1.73, I2=0%). There were no differences in peri-operative outcomes among JW patients and controls (OR 0.97, 95% CI 0.39-2.41, I2=18% for myocardial infarction; OR 0.80, 95% CI 0.51-1.25, I2=0% for re-exploration for bleeding). JW patients had a higher level of preoperative Hb (Standardized Mean Difference [SMD] 0.32, 95% CI 0.06-0.57) and a trend toward a higher level of postoperative Hb (SMD 0.44, 95% CI -0.01-0.90). A slightly lower CPB time emerged in JWs compared with controls (SMD -0.11, 95% CI -0.30-0.07). Conclusions: JW patients undergoing cardiac surgery, with avoidance of blood transfusions, did not have substantially different peri-operative outcomes compared with controls, with specific reference to mortality, myocardial infarction, and re-exploration for bleeding. Our results support the safety and feasibility of bloodless cardiac surgery, applying patient blood management strategies.

2023 - Cardiology in a Digital Age: Opportunities and Challenges for e-Health: A Literature Review [Articolo su rivista]
Pegoraro, V.; Bidoli, C.; Dal Mas, F.; Bert, F.; Cobianchi, L.; Zantedeschi, M.; Campostrini, S.; Migliore, F.; Boriani, G.
abstract

To date, mortality rates associated with heart diseases are dangerously increasing, making them the leading cause of death globally. From this point of view, digital technologies can provide health systems with the necessary support to increase prevention and monitoring, and improve care delivery. The present study proposes a review of the literature to understand the state of the art and the outcomes of international experiences. A reference framework is defined to develop reflections to optimize the use of resources and technologies, favoring the development of new organizational models and intervention strategies. Findings highlight the potential significance of e-health and telemedicine in supporting novel solutions and organizational models for cardiac illnesses as a response to the requirements and restrictions of patients and health systems. While privacy concerns and technology-acceptance-related issues arise, new avenues for research and clinical practice emerge, with the need to study ad hoc managerial models according to the type of patient and disease.

2023 - Cardiovascular Reasons for Access to a Tertiary Oncological Emergency Service: The CARILLON Study [Articolo su rivista]
Imberti, J. F.; Maisano, A.; Rampini, F.; Minnocci, M.; Bertuglia, F.; Mantovani, M.; Cherubini, B.; Mei, D. A.; Ferrara, L.; Bonini, N.; Valenti, A. C.; Vitolo, M.; Longo, G.; Boriani, G.
abstract

Background: The prevalence of acute cardiovascular diseases (CVDs) in cancer patients is steadily increasing and represents a significant reason for admission to the emergency department (ED). Methods: We conducted a prospective observational study, enrolling consecutive patients with cancer presenting to a tertiary oncological ED and consequently admitted to the oncology ward. Two groups of patients were identified based on main symptoms that lead to ED presentation: symptoms potentially related to CVD vs. symptoms potentially not related to CVD. The aims of the study were to describe the prevalence of symptoms potentially related to CVD in this specific setting and to evaluate the prevalence of definite CV diagnoses at discharge. Secondary endpoints were new intercurrent in-hospital CV events occurrence, length of stay in the oncology ward, and mid-term mortality for all-cause. Results: A total of 469 patients (51.8% female, median age 68.0 [59.1–76.3]) were enrolled. One hundred and eighty-six out of 469 (39.7%) presented to the ED with symptoms potentially related to CVD. Baseline characteristics were substantially similar between the two study groups. A discharge diagnosis of CVD was confirmed in 24/186 (12.9%) patients presenting with symptoms potentially related to CVD and in no patients presenting without symptoms potentially related to CVD (p < 0.01). During a median follow-up of 3.4 (1.2–6.5) months, 204 (43.5%) patients died (incidence rate of 10.1 per 100 person/months). No differences were found between study groups in terms of all-cause mortality (hazard ratio [HR]: 0.85, 95% confidence interval [CI] 0.64–1.12), new in-hospital CV events (HR: 1.03, 95% CI 0.77–1.37), and length of stay (p = 0.57). Conclusions: In a contemporary cohort of cancer patients presenting to a tertiary oncological ED and admitted to an oncology ward, symptoms potentially related to CVD were present in around 40% of patients, but only a minority were actually diagnosed with an acute CVD.

2023 - Clinical Outcomes in Metabolically Healthy and Unhealthy Obese and Overweight Patients With Atrial Fibrillation: Findings From the GLORIA-AF Registry [Articolo su rivista]
Corica, Bernadette; Romiti, Giulio Francesco; Proietti, Marco; Mei, Davide Antonio; Boriani, Giuseppe; Chao, Tze-Fan; Olshansky, Brian; Huisman, Menno V; Lip, Gregory Y H
abstract

Objective: To explore the association between metabolic status, body mass index (BMI), and natural history of patients with atrial fibrillation (AF). Methods: The global, prospective GLORIA-AF Registry Phase II and III included patients with recent diagnosis of AF between November 2011 and December 2014 for Phase II and between January 2014 and December 2016 for Phase III. With this analysis, we categorized patients with AF according to BMI (normal weight [18.5 to 24.9 kg/m2], overweight [25.0 to 29.9 kg/m2], obese [30.0 to 60.0 kg/m2]) and metabolic status (presence of hypertension, diabetes, and hyperlipidemia). We analyzed risk of major outcomes using multivariable Cox regression analyses; the primary outcome was the composite of all-cause death and major adverse cardiovascular events. Results: There were 24,828 (mean age, 70.1±10.3 years; 44.6% female) patients with AF included. Higher BMI was associated with metabolically unhealthy status and higher odds of receiving oral anticoagulants and other treatments. Normal-weight unhealthy patients showed a higher risk of the primary composite outcome (adjusted hazard ratio [aHR], 1.20; 95% CI, 1.01 to 1.42) and thromboembolism, whereas a lower risk of cardiovascular death (aHR, 0.35; 95% CI, 0.14 to 0.88) and major adverse cardiovascular events (aHR, 0.56; 95% CI, 0.33 to 0.93) was observed in metabolically healthy obese individuals. Unhealthy metabolic groups were also associated with increased risk of major bleeding (aHR, 1.51 [95% CI, 1.04 to 2.20] and aHR, 1.96 [95% CI, 1.34 to 2.85] in overweight and obese groups, respectively). Conclusion: Increasing BMI was associated with poor metabolic status and with more intensive treatment. Prognosis was heterogeneous between BMI groups, with metabolically unhealthy patients showing higher risk of adverse events.

2023 - Combination of an implantable defibrillator multi-sensor heart failure index and an apnea index for the prediction of atrial high-rate events [Articolo su rivista]
Bertini, M.; Vitali, F.; D'Onofrio, A.; Vitulano, G.; Calo, L.; Savarese, G.; Santobuono, V. E.; Russo, A. D.; Mattera, A.; Santoro, A.; Calvanese, R.; Arena, G.; Amellone, C.; Ziacchi, M.; Palmisano, P.; Santini, L.; Mazza, A.; Campari, M.; Valsecchi, S.; Boriani, G.
abstract

Aims Patients with atrial fibrillation frequently experience sleep disorder breathing, and both conditions are highly prevalent in presence of heart failure (HF). We explored the association between the combination of an HF and a sleep apnoea (SA) index and the incidence of atrial high-rate events (AHRE) in patients with implantable defibrillators (ICDs). Methods and results Data were prospectively collected from 411 consecutive HF patients with ICD. The IN-alert HF state was measured by the multi-sensor HeartLogic Index (>16), and the ICD-measured Respiratory Disturbance Index (RDI) was computed to identify severe SA. The endpoints were as follows: daily AHRE burden of ≥5 min, ≥6 h, and ≥23 h. During a median follow-up of 26 months, the time IN-alert HF state was 13% of the total observation period. The RDI value was ≥30 episodes/h (severe SA) during 58% of the observation period. An AHRE burden of ≥5 min/day was documented in 139 (34%) patients, ≥6 h/ day in 89 (22%) patients, and ≥23 h/day in 68 (17%) patients. The IN-alert HF state was independently associated with AHRE regardless of the daily burden threshold: hazard ratios from 2.17 for ≥5 min/day to 3.43 for ≥23 h/day (P < 0.01). An RDI ≥ 30 episodes/h was associated only with AHRE burden ≥5 min/day [hazard ratio 1.55 (95% confidence interval: 1.11–2.16), P = 0.001]. The combination of IN-alert HF state and RDI ≥ 30 episodes/h accounted for only 6% of the follow-up period and was associated with high rates of AHRE occurrence (from 28 events/100 patient-years for AHRE burden ≥5 min/day to 22 events/100 patient-years for AHRE burden ≥23 h/day). Conclusions In HF patients, the occurrence of AHRE is independently associated with the ICD-measured IN-alert HF state and RDI ≥ 30 episodes/h. The coexistence of these two conditions occurs rarely but is associated with a very high rate of AHRE occurrence.

2023 - Comparative analysis of level of evidence and class of recommendation for 50 clinical practice guidelines released by the European Society of Cardiology from 2011 to 2022 [Articolo su rivista]
Boriani, G.; Venturelli, A.; Imberti, J. F.; Bonini, N.; Mei, D. A.; Vitolo, M.
abstract

Background: The European Society of Cardiology (ESC) clinical practice guidelines are essential tools for decision-making. Aim: To analyze the level of evidence (LOE) and the class of recommendations in the ESC guidelines released in the last 12 years. Methods: We evaluated 50 ESC guidelines released from 2011 to 2022, related to 27 topics and categorized them into seven macro-groups. We analyzed every recommendation in terms of LOE and class of recommendation, calculating their relative proportions and changes over time in consecutive editions of the same guideline. Results: A total of 6972 recommendations were found, with an increase in number per year over time. Among the 50 ESC guidelines, the proportional distribution of classes of recommendations was 49% for Class I, 29% for Class IIa, 15% for Class IIb, and 8% for Class III. Overall, 16% of the recommendations were classified as LOE A, 31% LOE B and 53% LOE C. The field of preventive cardiology had the largest proportion of LOE A, while the lowest was in the field of valvular, myocardial, pericardial and pulmonary diseases. The overall proportion of LOE A recommendations in the most recent guidelines compared to their prior versions increased from 17% to 20%. Conclusions: The recommendations included in the ESC guidelines widely differ in terms of quality of evidence, with only 16% supported by the highest quality of evidence. Although a slight global increase in LOE A recommendations was observed in recent years, further scientific research efforts are needed to increase the quality of evidence.

2023 - Contemporary management of atrial fibrillation and the predicted vs. absolute risk of ischaemic stroke despite treatment: a report from ESC-EHRA EORP-AF Long-Term General Registry [Articolo su rivista]
Ding, Wern Yew; Blomström-Lundqvist, Carina; Fauchier, Laurent; Marin, Francisco; Potpara, Tatjana S; Boriani, Giuseppe; Lip, Gregory Y H
abstract

Risk stratification in patients with atrial fibrillation (AF) is important to facilitate guideline-directed therapies. The Calculator of Absolute Stroke Risk (CARS) scheme enables an individualized estimation of 1-year absolute risk of stroke in AF. We aimed to investigate the predicted and absolute risks of ischaemic stroke, and evaluate whether CARS (and CHA2DS2-VASc score) may be useful for identifying high risk patients with AF despite contemporary treatment.

2023 - Drug management of atrial fibrillation in light of guidelines and current evidence: an Italian Survey on behalf of Italian Association of Arrhythmology and Cardiac Pacing [Articolo su rivista]
Diemberger, I.; Imberti, J. F.; Spagni, S.; Rapacciuolo, A.; Curcio, A.; Attena, E.; Amadori, M.; De Ponti, R.; D'Onofrio, A.; Boriani, G.
abstract

AimAtrial fibrillation is a multifaceted disease requiring personalized treatment, in accordance with current ESC guidelines. Despite a wide range of literature, we still have various aspects dividing the opinion of the experts in rate control, rhythm control and thromboembolic prophylaxis. The aim of this survey was to provide a country-wide picture of current practice regarding atrial fibrillation pharmacological management according to a patient's characteristics.MethodsData were collected using an in-person survey that was administered to members of the Italian Association of Arrhythmology and Cardiac Pacing.ResultsWe collected data from 106 physicians, working in 72 Italian hospitals from 15 of 21 regions. Our work evidenced a high inhomogeneity in atrial fibrillation management regarding rhythm control, rate control and thromboembolic prophylaxis in both acute and chronic patients. This element was more pronounced in settings in which literature shows a lack of evidence and, consequently, the indications provided by the guidelines are weak or absent.ConclusionThis National survey evidenced a high inhomogeneity in current approaches adopted for atrial fibrillation management by a sample of Italian cardiologist experts in arrhythmia management. Further studies are needed to explore if these divergences are associated with different long-term outcomes.

2023 - EHRA expert consensus document on the management of arrhythmias in frailty syndrome, endorsed by the Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), Latin America Heart Rhythm Society (LAHRS), and Cardiac Arrhythmia Society of Southern Africa (CASSA) [Articolo su rivista]
Savelieva, I.; Fumagalli, S.; Kenny, R. A.; Anker, S.; Benetos, A.; Boriani, G.; Bunch, J.; Dagres, N.; Dubner, S.; Fauchier, L.; Ferrucci, L.; Israel, C.; Kamel, H.; Lane, D. A.; Lip, G. Y. H.; Marchionni, N.; Obel, I.; Okumura, K.; Olshansky, B.; Potpara, T.; Stiles, M. K.; Tamargo, J.; Ungar, A.; Kosiuk, J.; Larsen, T. B.; Dinov, B.; Estner, H.; Garcia, R.; Costa, F. M. M.; Lampert, R.; Lin, Y. -J.; Chin, A.; Rodriguez, H. A.; Strandberg, T.; Grodzicki, T.
abstract

There is an increasing proportion of the general population surviving to old age with significant chronic disease, multimorbidity, and disability. The prevalence of pre-frail state and frailty syndrome increases exponentially with advancing age and is associated with greater morbidity, disability, hospitalization, institutionalization, mortality, and health care resource use. Frailty represents a global problem, making early identification, evaluation, and treatment to prevent the cascade of events leading from functional decline to disability and death, one of the challenges of geriatric and general medicine. Cardiac arrhythmias are common in advancing age, chronic illness, and frailty and include a broad spectrum of rhythm and conduction abnormalities. However, no systematic studies or recommendations on the management of arrhythmias are available specifically for the elderly and frail population, and the uptake of many effective antiarrhythmic therapies in these patients remains the slowest. This European Heart Rhythm Association (EHRA) consensus document focuses on the biology of frailty, common comorbidities, and methods of assessing frailty, in respect to a specific issue of arrhythmias and conduction disease, provide evidence base advice on the management of arrhythmias in patients with frailty syndrome, and identifies knowledge gaps and directions for future research.

2023 - Early diagnosis and better rhythm management to improve outcomes in patients with atrial fibrillation: the 8th AFNET/EHRA consensus conference [Articolo su rivista]
Schnabel, Renate B; Marinelli, Elena Andreassi; Arbelo, Elena; Boriani, Giuseppe; Boveda, Serge; Buckley, Claire M; Camm, A John; Casadei, Barbara; Chua, Winnie; Dagres, Nikolaos; de Melis, Mirko; Desteghe, Lien; Diederichsen, Søren Zöga; Duncker, David; Eckardt, Lars; Eisert, Christoph; Engler, Daniel; Fabritz, Larissa; Freedman, Ben; Gillet, Ludovic; Goette, Andreas; Guasch, Eduard; Svendsen, Jesper Hastrup; Hatem, Stéphane N; Haeusler, Karl Georg; Healey, Jeff S; Heidbuchel, Hein; Hindricks, Gerhard; Hobbs, F D Richard; Hübner, Thomas; Kotecha, Dipak; Krekler, Michael; Leclercq, Christophe; Lewalter, Thorsten; Lin, Honghuang; Linz, Dominik; Lip, Gregory Y H; Løchen, Maja Lisa; Lucassen, Wim; Malaczynska-Rajpold, Katarzyna; Massberg, Steffen; Merino, Jose L; Meyer, Ralf; Mont, Lluıs; Myers, Michael C; Neubeck, Lis; Niiranen, Teemu; Oeff, Michael; Oldgren, Jonas; Potpara, Tatjana S; Psaroudakis, George; Pürerfellner, Helmut; Ravens, Ursula; Rienstra, Michiel; Rivard, Lena; Scherr, Daniel; Schotten, Ulrich; Shah, Dipen; Sinner, Moritz F; Smolnik, Rüdiger; Steinbeck, Gerhard; Steven, Daniel; Svennberg, Emma; Thomas, Dierk; True Hills, Mellanie; van Gelder, Isabelle C; Vardar, Burcu; Palà, Elena; Wakili, Reza; Wegscheider, Karl; Wieloch, Mattias; Willems, Stephan; Witt, Henning; Ziegler, André; Daniel Zink, Matthias; Kirchhof, Paulus
abstract

Aims Despite marked progress in the management of atrial fibrillation (AF), detecting AF remains difficult and AF-related complications cause unacceptable morbidity and mortality even on optimal current therapy. Methods and results This document summarizes the key outcomes of the 8th AFNET/EHRA Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA). Eighty-three international experts met in Hamburg for 2 days in October 2021. Results of the interdisciplinary, hybrid discussions in breakout groups and the plenary based on recently published and unpublished observations are summarized in this consensus paper to support improved care for patients with AF by guiding prevention, individualized management, and research strategies. The main outcomes are (i) new evidence supports a simple, scalable, and pragmatic population-based AF screening pathway; (ii) rhythm management is evolving from therapy aimed at improving symptoms to an integrated domain in the prevention of AF-related outcomes, especially in patients with recently diagnosed AF; (iii) improved characterization of atrial cardiomyopathy may help to identify patients in need for therapy; (iv) standardized assessment of cognitive function in patients with AF could lead to improvement in patient outcomes; and (v) artificial intelligence (AI) can support all of the above aims, but requires advanced interdisciplinary knowledge and collaboration as well as a better medico-legal framework. Conclusions Implementation of new evidence-based approaches to AF screening and rhythm management can improve outcomes in patients with AF. Additional benefits are possible with further efforts to identify and target atrial cardiomyopathy and cognitive impairment, which can be facilitated by AI.

2023 - Economic analysis of remote monitoring in patients with implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators in the Trento area, Italy [Articolo su rivista]
Marini, M.; Videsott, L.; Dalle Fratte, C. F.; Francesconi, A.; Bonvicini, E.; Quintarelli, S.; Martin, M.; Guarracini, F.; Coser, A.; Benetollo, P. P.; Bonmassari, R.; Boriani, G.
abstract

Introduction: Remote monitoring (RM) technologies have the potential to improve patient care by increasing compliance, providing early indications of heart failure (HF), and potentially allowing for therapy optimization to prevent HF admissions. The aim of this retrospective study was to assess the clinical and economic consequences of RM vs. standard monitoring (SM) through in-office cardiology visits, in patients carrying a cardiac implantable electronic device (CIED). Methods: Clinical and resource consumption data were extracted from the Electrophysiology Registry of the Trento Cardiology Unit, which has been systemically collecting patient information from January 2011 to February 2022. From a clinical standpoint, survival analysis was conducted, and incidence of cardiovascular (CV) related hospitalizations was measured. From an economic standpoint, direct costs of RM and SM were collected to compare the cost per treated patient over a 2-year time horizon. Propensity score matching (PSM) was used to reduce the effect of confounding biases and the unbalance of patient characteristics at baseline. Results: In the enrollment period, N = 402 CIED patients met the inclusion criteria and were included in the analysis (N = 189 patients followed through SM; N = 213 patients followed through RM). After PSM, comparison was limited to N = 191 patients in each arm. After 2-years follow-up since CIED implantation, mortality rate for any cause was 1.6% in the RM group and 19.9% in the SM group (log-rank test, p < 0.0001). Also, a lower proportion of patients in the RM group (25.1%) were hospitalized for CV-related reasons, compared to the SM group (51.3%; p < 0.0001, two-sample test for proportions). Overall, the implementation of the RM program in the Trento territory was cost-saving in both payer and hospital perspectives. The investment required to fund RM (a fee for service in the payer perspective, and staffing costs for hospitals), was more than offset by the lower rate of hospitalizations for CV-related disease. RM adoption generated savings of −€4,771 and −€6,752 per patient in 2 years, in the payer and hospital perspective, respectively. Conclusion: RM of patients carrying CIED improves short-term (2-years) morbidity and mortality risks, compared to SM and reduces direct management costs for both hospitals and healthcare services.

2023 - Effects of Ivabradine on Right Ventricular Systolic Function in Patients With Chronic Obstructive Pulmonary Disease and Cor Pulmonale [Articolo su rivista]
Rossi, R.; Coppi, F.; Sgura, F. A.; Monopoli, D. E.; Arrotti, S.; Talarico, M.; Boriani, G.
abstract

Cor pulmonale is a clinical syndrome associated with pulmonary hypertension, frequently complicated by congestive heart failure, commonly caused by chronic obstructive pulmonary disease (COPD). Most patients with cor pulmonale have tachycardia. However, heart rate (HR) reduction represents a primary treatment goal to improve the survival and quality of life in these patients. Ivabradine can selectively slow HR at rest and during exercise. In this prospective study, we tested the hemodynamic effects, invasively determined using right-sided cardiac catheterization, of reducing HR with ivabradine. We selected 18 patients (13 men [72.2%], mean age 67 ± 10 years) with COPD and cor pulmonale, presenting with sinus tachycardia. All patients performed clinical evaluation, electrocardiogram, spirometry, echocardiogram, 6-minute walking distance, and right-sided cardiac catheterization within 1 month of enrollment. All tests were repeated after 6 months of ivabradine treatment (median assumed dose 11.9 mg/die). We noticed a significant decrease of HR (from 98 ± 7 to 77 ± 8 beats/min, p = 0.0001), with a concomitant reduction of the congestion index (from 25.9 ± 5.1 to 19.4 ± 5.7 mm Hg, p = 0.001), and the consequent improvement of the right ventricular systolic performance (right ventricular stroke volume augmented from 56.7 ± 7.9 to 75.2 ± 8.6 ml/beat, p = 0.0001). This allows an improvement in clinical status and exercise tolerance (Borg scale score decreased from 5.2 ± 1.4 to 4.1 ± 1.3, p = 0.01 and the 6-minute walking distance increased to 252 ± 65 to 377 ± 59 m, p = 0.001). In conclusion, HR reduction significantly improves hemodynamic and clinical status of patients with tachycardia affected by COPD and cor pulmonale.

2023 - Erratum: 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS): Developed by the task force on cardio-oncology of the European Society of Cardiology (ESC) (European Heart Journal - Cardiovascular Imaging (2022) 23:3 (e333–e465) DOI: 10.1093/ehjci/jeac106) [Articolo su rivista]
Lyon, A. R.; Lopez-Fernandez, T.; Couch, L. S.; Asteggiano, R.; Aznar, M. C.; Bergler-Klein, J.; Boriani, G.; Cardinale, D.; Cordoba, R.; Cosyns, B.; Cutter, D. J.; de Azambuja, E.; de Boer, R. A.; Dent, S. F.; Farmakis, D.; Gevaert, S. A.; Gorog, D. A.; Herrmann, J.; Lenihan, D.; Moslehi, J.; Moura, B.; Salinger, S. S.; Stephens, R.; Suter, T. M.; Szmit, S.; Tamargo, J.; Thavendiranathan, P.; Tocchetti, C. G.; van der Meer, P.; van der Pal, H. J. H.
abstract

This is an erratum to: Alexander R Lyon, Teresa López-Fernández, Liam S Couch, Riccardo Asteggiano, Marianne C Aznar, Jutta Bergler-Klein, Giuseppe Boriani, Daniela Cardinale, Raul Cordoba, Bernard Cosyns, David J Cutter, Evandro de Azambuja, Rudolf A de Boer, Susan F Dent, Dimitrios Farmakis, Sofie A Gevaert, Diana A Gorog, Joerg Herrmann, Daniel Lenihan, Javid Moslehi, Brenda Moura, Sonja S Salinger, Richard Stephens, Thomas M Suter, Sebastian Szmit, Juan Tamargo, Paaladinesh Thavendiranathan, Carlo G Tocchetti, Peter van der Meer, Helena J H van der Pal, ESC Scientific Document Group, 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS): Developed by the task force on cardio-oncology of the European Society of Cardiology (ESC), European Heart Journal - Cardiovascular Imaging, Volume 23, Issue 10, October 2022, Pages e333–e465, https://doi.org/10.1093/ehjci/jeac106 The following change has been made to the article: In Figure 7, the category ‘Very high risk’ has been corrected online to ‘High and very high risk’.

2023 - Erratum: How to use digital devices to detect and manage arrhythmias: an EHRA practical guide (EP Europace (2022) 24:6 (979-1005) DOI: 10.1093/europace/euac038) [Articolo su rivista]
Svennberg, E.; Tjong, F.; Goette, A.; Akoum, N.; Di Biase, L.; Bordachar, P.; Boriani, G.; Burri, H.; Conte, G.; Deharo, J. C.; Deneke, T.; Drossart, I.; Duncker, D.; Han, J. K.; Heidbuchel, H.; Jais, P.; de Oliveira Figueiredo, M. J.; Linz, D.; Lip, G. Y. H.; Malaczynska-Rajpold, K.; Marquez, M. F.; Ploem, C.; Soejima, K.; Stiles, M. K.; Wierda, E.; Vernooy, K.; Leclercq, C.; Meyer, C.; Pisani, C.; Pak, H. N.; Gupta, D.; Purerfellner, H.; Crijns, H. J. G. M.; Chavez, E. A.; Willems, S.; Waldmann, V.; Dekker, L.; Wan, E.; Kavoor, P.; Turagam, M. K.; Sinner, M.
abstract

In the originally published version of this manuscript, the names of authors Marcio Jansen de Oliveira Figueiredo and Manlio F. Márquez were incorrectly given. Both names have now been corrected online. In addition, the following affiliation was inadvertently omitted for author Manlio F. Márquez: Cardiology, Electrophysiology Service, American British Cowdray Medical Center, Mexico City, México This affiliation has now been added to the online version of the manuscript as affiliation 27 and all subsequent affiliations in this manuscript affected by this change have been updated accordingly.

2023 - Factors Associated with Progression of Atrial Fibrillation and Impact on All-Cause Mortality in a Cohort of European Patients [Articolo su rivista]
Vitolo, M.; Proietti, M.; Imberti, J. F.; Bonini, N.; Romiti, G. F.; Mei, D. A.; Malavasi, V. L.; Diemberger, I.; Fauchier, L.; Marin, F.; Nabauer, M.; Potpara, T. S.; Dan, G. -A.; Lip, G. Y. H.; Boriani, G.
abstract

Background: Paroxysmal atrial fibrillation (AF) may often progress towards more sustained forms of the arrhythmia, but further research is needed on the factors associated with this clinical course. Methods: We analyzed patients enrolled in a prospective cohort study of AF patients. Patients with paroxysmal AF at baseline or first-detected AF (with successful cardioversion) were included. According to rhythm status at 1 year, patients were stratified into: (i) No AF progression and (ii) AF progression. All-cause death was the primary outcome. Results: A total of 2688 patients were included (median age 67 years, interquartile range 60–75, females 44.7%). At 1-year of follow-up, 2094 (77.9%) patients showed no AF progression, while 594 (22.1%) developed persistent or permanent AF. On multivariable logistic regression analysis, no physical activity (odds ratio [OR] 1.35, 95% CI 1.02–1.78), valvular heart disease (OR 1.63, 95% CI 1.23–2.15), left atrial diameter (OR 1.03, 95% CI 1.01–1.05), or left ventricular ejection fraction (OR 0.98, 95% CI 0.97–1.00) were independently associated with AF progression at 1 year. After the assessment at 1 year, the patients were followed for an extended follow-up of 371 days, and those with AF progression were independently associated with a higher risk for all-cause death (adjusted hazard ratio 1.77, 95% CI 1.09–2.89) compared to no-AF-progression patients. Conclusions: In a contemporary cohort of AF patients, a substantial proportion of patients presenting with paroxysmal or first-detected AF showed progression of the AF pattern within 1 year, and clinical factors related to cardiac remodeling were associated with progression. AF progression was associated with an increased risk of all-cause mortality.

2023 - Features of Clinical Complexity in European Patients With Atrial Fibrillation: A Report From a European Observational Prospective AF Registry [Articolo su rivista]
Proietti, M.; Romiti, G. F.; Corica, B.; Mei, D. A.; Bonini, N.; Vitolo, M.; Imberti, J. F.; Boriani, G.; Lip, G. Y. H.
abstract

There is increasing concern regarding impact of clinical complexity in patients with atrial fibrillation (AF). We explored the impact of different clinical complexity features in AF patients. We analyzed patients from a prospective, observational, multicenter Europe-wide AF registry. Features of clinical complexity among patients with CHA2DS2-VASc ≥2 were: (1) history of bleeding; (2) frailty; (3) chronic kidney disease (CKD); (4) ≥2 features. A total of 10,169 patients were analyzed. Of these, 141 (1.4%) had history of bleeding, 954 (9.4%) were frail, 1767 (17.4%) had CKD and 1253 (12.3%) had ≥2 features. All features of clinical complexity were less treated with OAC. History of bleeding (HR 1.94, 95% CI 1.32-2.85), frailty (HR 1.38, 95% CI 1.11-1.71), CKD (HR 1.50, 95% 1.28-1.75) and ≥2 features (HR 2.08, 95% CI 1.73-2.51) were associated with outcomes. Presence of features of clinical complexity is associated with lower use of OAC and higher risk of outcomes.

2023 - Ibrutinib and Bruton's tyrosine kinase inhibitors in chronic lymphocytic leukemia: focus on atrial fibrillation and ventricular tachyarrhythmias/sudden cardiac death [Articolo su rivista]
Boriani, Giuseppe; Menna, Pierantonio; Morgagni, Riccardo; Minotti, Giorgio; Vitolo, Marco
abstract

Background: The natural history of chronic lymphocytic leukemia (CLL) was dramatically improved by the introduction of ibrutinib, a Bruton's kinase (BTK) inhibitor. In this review we aimed to summarize and critically evaluate the association between first and second generation BTK inhibitors and the risk of atrial fibrillation (AF) and ventricular arrhythmias (VA). Summary: Since the first clinical experience, the development of AF was observed as the result of off-target effects that likely combined with patient's predisposing risk factors and concomitant cardiac morbidities. More recently both ibrutinib dose reduction and arrhythmia management allowed long-term treatment, with positive effects on progression-free survival and reduced all-cause mortality as well. Second-generation BTK inhibitors, acalabrutinib and zanubrutinib have been tested and validated in CLL. A lower occurrence of AF as compared with ibrutinib has been found, although AF has always been a secondary endpoint of all studies that probed these agents. Key Messages: For this reason, caution should be exercised before concluding that second-generation BTK inhibitors are safer than ibrutinib. Recent data on the effectiveness of ibrutinib over a follow-up of 8 years show a remarkable benefit on all-cause mortality, which is of great value also for interpreting the clinical impact of the few cases of VA and sudden cardiac death (SCD) reported for ibrutinib, independently of QT lengthening. Since a risk of VA and SCD has been recently reported also during treatment with second-generation BTK inhibitors, it appears that this risk, usually reaching its maximum size effect at long-term follow-up, likely denotes a class effect of BTK-inhibitors.

2023 - Impact of ABC (Atrial Fibrillation Better Care) pathway adherence in high-risk subgroups with atrial fibrillation: A report from the ESC-EHRA EORP-AF long-term general registry [Articolo su rivista]
Ding, W. Y.; Proietti, M.; Romiti, G. F.; Vitolo, M.; Fawzy, A. M.; Boriani, G.; Marin, F.; Blomstrom-Lundqvist, C.; Potpara, T. S.; Fauchier, L.; H Lip, G. Y.
abstract

Background: Effects of Atrial Fibrillation Better Care (ABC) adherence among high-risk atrial fibrillation (AF) subgroups remains unknown. We aimed to evaluate the impact of ABC adherence on clinical outcomes in these high-risk patients. Methods: EORP-AF General Long-Term Registry is a prospective, observational registry from 250 centres across 27 European countries. High-risk patients were defined as those with either CKD (eGFR <60 mL/min/1.73m2), elderly patients (≥75 years) or prior thromboembolism. Primary outcome was a composite event of all-cause death, thromboembolism and acute coronary syndrome. Results: 6646 patients with AF were screened (median age was 70 [IQR 61 – 77] years; 40.2% females). There were 3304 (54.2%) patients with either CKD (n = 1750), older age (n = 2236) or prior thromboembolism (n = 728). Among these, 924 (28.0%) were managed as adherent to ABC. At 2-year follow-up, 966 (14.5%) patients reported the primary outcome. The incidence of the primary outcome was significantly lower in high-risk patients managed as adherent to ABC pathway (IRR 0.53 [95%CI, 0.43 – 0.64]). Consistent results were obtained in the individual subgroups. Using multivariable Cox proportional hazards analysis, ABC adherence in the high-risk cohort was independently associated with a lower risk of the primary outcome (aHR 0.64 [95%CI, 0.51 – 0.80]), as well as in the CKD (aHR 0.51 [95%CI, 0.37 – 0.70]) and elderly subgroups (aHR 0.69 [95%CI, 0.53 – 0.90]). Overall, there was greater reduction in the risk of primary outcome as more ABC criteria were fulfilled, both in the overall high-risk patients (aHR 0.39 [95%CI, 0.25 – 0.61]), as well as in the individual subgroups. Conclusion: In a large, contemporary cohort of patients with AF, we demonstrate that adherence to the ABC pathway was associated with a significant benefit among high-risk patients with either CKD, advanced age (≥75 years old) or prior thromboembolism.

2023 - Implications of Clinical Risk Phenotypes on the Management and Natural History of Atrial Fibrillation: A Report From the GLORIA-AF [Articolo su rivista]
Romiti, Giulio Francesco; Proietti, Marco; Corica, Bernadette; Bonini, Niccolò; Boriani, Giuseppe; Huisman, Menno V; Lip, Gregory Y H
abstract

: Background Clinical risk factors are common among patients with atrial fibrillation (AF), but there are still limited data on their association with oral anticoagulant (OAC) treatment patterns and major outcomes. We aim to analyze the association between clinical risk phenotypes on AF treatment patterns and the risk of major outcomes. Methods and Results The GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation) phase 2 and 3 registries enrolled patients with a recent diagnosis of AF between 2011 and 2016. We defined 4 features of clinical risk among patients with CHA2DS2-VASc ≥2: elderly individuals (aged ≥80 years), chronic kidney disease (estimated glomerular filtration rate <45 mL/min), history of stroke, and history of bleeding. We analyzed the odds of receiving OAC and the risk of OAC discontinuation and adverse events at follow-up according to specific combinations and cumulative burden of these features. Primary outcome was the composite of all-cause death, thromboembolism, and major bleeding. Among 28 891 (mean±SD age, 70.1±10.5 years; 45.5% women) patients included, 10 797 (37.3%) had at least 1 clinical risk feature. OAC use was lower among patients in the elderly group (odds ratio [OR], 0.85 [95% CI, 0.75-0.96]), those with history of both stroke and bleeding (OR, 0.45 [95% CI, 0.35-0.56]), and those with multiple features (OR, 0.71 [95% CI, 0.62-0.82]). Increasing burden of clinical risk features was associated with OAC discontinuation, with highest magnitude in those with ≥3 features (hazard ratio [HR], 1.68 [95% CI, 1.31-2.15]). Groups with increasingly complex clinical risk phenotypes were associated with the occurrence of the primary composite outcome, with the highest figures observed for groups with a history of both stroke and bleeding (adjusted HR, 2.36 [95% CI, 1.83-3.04]) and multiple features (adjusted HR, 2.86 [95% CI, 2.52-3.25]). Conclusions In patients with AF, clinical risk phenotypes are multifaceted and heterogenous, and they are associated with differences in stroke prevention and worse prognosis.

2023 - Improved prognosis after cardiac resynchronization therapy over a decade [Articolo su rivista]
Leyva, F.; Zegard, A.; Patel, P.; Stegemann, B.; Marshall, H.; Ludman, P.; de Bono, J.; Boriani, G.; Qiu, T.
abstract

Aims The past decade has seen an increased delivery of cardiac resynchronization therapy (CRT) for patients with heart failure (HF). We explored whether clinical outcomes after CRT have changed from the perspective of an entire public healthcare system. Methods and results A national database covering the population of England (56.3 million in 2019) was used to explore clinical outcomes after CRT from 2010 to 2019. A total of 64 698 consecutive patients (age 71.4 ± 11.7 years; 74.8% male) underwent CRT-defibrillation [n = 32 313 (49.7%)] or CRT-pacing [n = 32 655 (50.3%)] implantation. From 2010–2011 to 2018–2019, there was a 76% increase in CRT implantations. During the same period, the proportion of patients with hypertension (59.6–73.4%), diabetes (26.5–30.8%), and chronic kidney disease (8.62–22.5%) increased, as did the Charlson comorbidity index (CCI ≥ 3 from 20.0% to 25.1%) (all P < 0.001). Total mortality decreased at 30 days (1.43–1.09%) and 1 year (9.51–8.13%) after implantation (both P < 0.001). At 2 years, total mortality [hazard ratio (HR): 0.72; 95% confidence interval (CI) 0.69–0.76] and total mortality or HF hospitalization (HR: 0.59; 95% CI 0.57–0.62) decreased from 2010–2011 to 2018–2019, after correction for age, race, sex, device type (CRT-defibrillation or pacing), comorbidities (hypertension, diabetes, chronic kidney disease, and myocardial infarction), or the CCI (HR: 0.81; 95% CI 0.77–0.85). Conclusions From the perspective of an entire public health system, survival has improved and HF hospitalizations have decreased after CRT implantation over the past decade. This prognostic improvement has occurred despite an increasing comorbidity burden.

2023 - In memory of Francesco Furlanello: a great advocate for dedicated commitment to effective, up-to-date, and expert management of cardiac arrhythmias and sports cardiology [Articolo su rivista]
Boriani, G.; Camm, A. J.
abstract

2023 - Insertable cardiac monitoring results in higher rates of atrial fibrillation diagnosis and oral anticoagulation prescription after ischaemic stroke [Articolo su rivista]
Boriani, G.; Auricchio, A.; Botto, G. L.; Joseph, J. M.; Roberts, G. J.; Grammatico, A.; Nabutovsky, Y.; Piccini, J. P.
abstract

Aims: After an ischaemic stroke, atrial fibrillation (AF) detection allows for improved secondary prevention strategies. This study aimed to compare AF detection and oral anticoagulant (OAC) initiation in patients with an insertable cardiac monitor (ICM) vs. external cardiac monitor (ECM) after ischaemic stroke. Methods and results: Medicare Fee-for-Service (FFS) insurance claims and Abbott Labs device registration data were used to identify patients hospitalized with an ischaemic stroke in 2017-2019 who received an ICM or ECM within 3 months. Patients with continuous Medicare FFS insurance and prescription drug enrolment in the prior year were included. Patients with prior AF, atrial flutter, cardiac devices, or OAC were excluded. Insertable cardiac monitor and ECM patients were propensity score matched 1:4 on demographics, comorbidities, and stroke hospitalization characteristics. The outcomes of interest were AF detection and OAC initiation evaluated with Kaplan-Meier and Cox proportional hazard regression analyses. A total of 5702 Medicare beneficiaries (ICM, n = 444; ECM, n = 5258) met inclusion criteria. The matched cohort consisted of 2210 Medicare beneficiaries (ICM, n = 442; ECM, n = 1768) with 53% female, mean age 75 years, and mean CHA2DS2-VASc score 4.6 (1.6). Insertable cardiac monitor use was associated with a higher probability of AF detection [(hazard ratio (HR) 2.88, 95% confidence interval (CI) (2.31, 3.59)] and OAC initiation [HR 2.91, CI (2.28, 3.72)] compared to patients monitored only with ECM. Conclusion: Patients with an ischaemic stroke monitored with an ICM were almost three times more likely to be diagnosed with AF and to be prescribed OAC compared to patients who received ECM only.

2023 - Integration of a Smartphone HF-Dedicated App in the Remote Monitoring of Heart Failure Patients with Cardiac Implantable Electronic Devices: Patient Access, Acceptance, and Adherence to Use [Articolo su rivista]
Ziacchi, M.; Molon, G.; Giudici, V.; Botto, G. L.; Viscusi, M.; Brasca, F.; Santoro, A.; Curcio, A.; Manzo, M.; Mauro, E.; Biffi, M.; Costa, A.; Dell'Aquila, A.; Casale, M. C.; Boriani, G.
abstract

(200 w) Introduction. Remote monitoring (RM) of cardiac implantable electronic device (CIED) diagnostics helps to identify patients potentially at risk of worsening heart failure (HF). Additionally, knowledge of patient HF-related symptoms is crucial for decision making. Patient smartphone applications may represent an ideal option to remotely collect this information. Purpose. To assess real-world HF patient access, acceptance, and adherence to use of an HF-dedicated smartphone application (HF app). Methods. In this study, 10 Italian hospitals administered a survey on smartphone/app use to HF patients with CIED. The subgroup who accepted it downloaded the HF app. Mean 1-year adherence of the HF app use was evaluated. Results. A total of 495 patients (67 ± 13 years, 79% males, 26% NYHA III–IV) completed the survey, of which 84% had access to smartphones and 85% were willing to use the HF app. In total, 311/495 (63%) downloaded the HF app. Patients who downloaded the HF app were younger and had higher school qualification. Patients who were ≥60 years old had higher mean 1-year adherence (54.1%) than their younger counterparts (42.7%; p < 0.001). Hospitals with RM-dedicated staff had higher mean 1-year patient adherence (64.0% vs. 33.5%; p < 0.001). Adherence to HF app decreased from 63.3% (weeks_1–13) to 42.2% (weeks_40–52, p < 0.001). Conclusions. High access and acceptance of smartphones/apps by HF patients with CIED allow HF app use for RM of patient signs/symptoms. Younger patients with higher school qualifications are more likely to accept HF app; however, older patients have higher long-term adherence.

2023 - Is there a reduced confidence towards direct oral anticoagulants compared to vitamin K antagonists in patients scheduled for an elective electrical cardioversion? The results of the BLITZ-AF study [Articolo su rivista]
Cemin, R.; Maggioni, A. P.; Boriani, G.; Di Pasquale, G.; Gonzini, L.; Lucci, D.; Colivicchi, F.; Gulizia, M. M.
abstract

Objective: To study the confidence of cardiologists in performing an electrical cardioversion in patients on oral anticoagulation (OA) with or without transoesophageal echocardiography (TOE). Methods: Data about atrial fibrillation (AF) patients admitted to cardiology wards for elective cardioversion (ECV) were extrapolated from the BLITZ-AF study. Percentage of vitamin K antagonists (VKAs), direct oral anticoagulants (DOAC) and heparin prescription were analysed in relation to the use of TOE before ECV. Results: Overall rate of TOE was 33.7% (240/713); it was used before ECV in 124/313 (39.6%) of DOACs patients and in 96/372 (25.8%) of the patients on VKAs, showing a significant reduced resort to TOE in VKAs patients (p = 0.0001). Among non-valvular patients TOE was more frequently performed in males, at younger ages and in patients on heparin when compared to patients treated with OA. TOE was also more frequently performed in tertiary hospitals and in hospitals with cardiology wards and electrophysiology labs, when compared to hospital provided only with cardiology wards. At multivariable analysis there was a significant less recourse to TOE in patients on VKAs (OR 0.47; 95% CI: 0.33–0.67) and higher recourse in the heparin group (OR: 3.85; 95% CI:1.59–9.28) with respect to patients on DOACs; a higher recourse to TOE was observed also in tertiary hospitals (OR 4.25; 95% CI 2.69–6.69) and in hospitals with cardiology wards and electrophysiology (EP) labs (OR 1.87; 95% CI 1.23–2.82). Conclusion: our study shows the reluctance in cardioverting patients on DOACs respect to VKAs without a previous TOE, despite adequate anticoagulant treatment.

2023 - Length of hospital stay for elective electrophysiological procedures: a survey from the European Heart Rhythm Association [Articolo su rivista]
Boriani, G.; Imberti, J. F.; Leyva, F.; Casado-Arroyo, R.; Chun, J.; Braunschweig, F.; Zylla, M. M.; Duncker, D.; Farkowski, M. M.; Purerfellner, H.; Merino, J. L.
abstract

AIMS: Electrophysiological (EP) operations that have traditionally involved long hospital lengths of stay (LOS) are now being undertaken as day case procedures. The coronavirus disease-19 pandemic served as an impetus for many centres to shorten LOS for EP procedures. This survey explores LOS for elective EP procedures in the modern era. METHODS AND RESULTS: An online survey consisting of 27 multiple-choice questions was completed by 245 respondents from 35 countries. With respect to de novo cardiac implantable electronic device (CIED) implantations, day case procedures were reported for 79.5% of implantable loop recorders, 13.3% of pacemakers (PMs), 10.4% of implantable cardioverter defibrillators (ICDs), and 10.2% of cardiac resynchronization therapy (CRT) devices. With respect to CIED generator replacements, day case procedures were reported for 61.7% of PMs, 49.2% of ICDs, and 48.2% of CRT devices. With regard to ablations, day case procedures were reported for 5.7% of atrial fibrillation (AF) ablations, 10.7% of left-sided ablations, and 17.5% of right-sided ablations. A LOS ≥ 2 days for CIED implantation was reported for 47.7% of PM, 54.5% of ICDs, and 56.9% of CRT devices and for 54.5% of AF ablations, 42.2% of right-sided ablations, and 46.1% of left-sided ablations. Reimbursement (43-56%) and bed availability (20-47%) were reported to have no consistent impact on the organization of elective procedures. CONCLUSION: There is a wide variation in the LOS for elective EP procedures. The LOS for some procedures appears disproportionate to their complexity. Neither reimbursement nor bed availability consistently influenced LOS.

2023 - Letter to the Editor, regarding Rakha S, Hammad A, Elmarsafawy H, Korkor MS, et al. (2023). A deeper look into the functions of right ventricle using three-dimensional echocardiography: the forgotten ventricle in children with systemic lupus erythematosus. Eur J Pediatr. 182:2807–2819 [Articolo su rivista]
Coppi, F.; Tampieri, F.; Palazzi, G.; Boschini, M.; Gianluca, P.; Leo, G.; Morgante, V.; Melegari, G.; Arrotti, S.; Manenti, A.; Mattioli, A. V.; Boriani, G.
abstract

2023 - Low Occurrence of Infections and Death in a Real-World Cohort of Patients with Cardiac Implantable Electronic Devices [Articolo su rivista]
Imberti, J. F.; Mei, D. A.; Fontanesi, R.; Gerra, L.; Bonini, N.; Vitolo, M.; Turco, V.; Casali, E.; Boriani, G.
abstract

Background. The incidence of infections and death in patients implanted with cardiac implantable electronic devices (CIEDs) is not fully known yet. Aim. To describe the incidence of CIED-related infection and death, and their potential predictors in a contemporary cohort of CIED patients. Methods. All consecutive patients implanted with a CIED at our institution were prospectively enrolled. Follow-up visits were performed 2 weeks after CIED implantation for all patients, and then every 6 months for implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy (CRT) patients and every 12 months for pacemaker (PM) patients. The adjudication of CIED-related infections was performed by two independent investigators and potential disagreement was resolved by a senior investigator. Results. Between September 2016 and August 2020, a total of 838 patients were enrolled (34.6% female; median age 77 (69.6–83.6); median PADIT score 2 (2–4)). PMs were implanted in 569 (68%) patients and ICD/CRT in 269 (32%) patients. All patients had pre-implant antibiotic prophylaxis and 5.5% had an antibiotic-eluting envelope. Follow-up data were available for 832 (99.2%) patients. After a median follow-up of 42.3 (30.2–56.4) months, five (0.6%) patients had a CIED-related infection and 212 (25.5%) patients died. Using multivariate Cox regression analysis, end-stage chronic kidney disease (CKD) requiring dialysis and therapy with corticosteroids was independently associated with a higher risk of infection (hazard ratio (HR): 14.20; 95% confidence interval (CI) 1.48–136.62 and HR: 14.71; 95% CI 1.53–141.53, respectively). Age (HR: 1.07; 95% CI 1.05–1.09), end-stage CKD requiring dialysis (HR: 6.13; 95% CI 3.38–11.13) and history of atrial fibrillation (HR: 1.47; 95% CI 1.12–1.94) were independently associated with all-cause death. Conclusions. In a contemporary cohort of CIED patients, mortality was substantially high and associated with clinical factors depicting a population at risk. On the other hand, the incidence of CIED-related infections was low.

2023 - Multimorbidity in atrial fibrillation: A call for integrated patient-centered care [Articolo su rivista]
Boriani, G.; Mei, D. A.; Imberti, J. F.
abstract

2023 - New Perspectives on Risk Stratification and Treatment in Patients with Atrial Fibrillation: An Analysis of Recent Contributions on the Journal of Cardiovascular Disease and Development [Articolo su rivista]
Boriani, G.; Bonini, N.; Imberti, J. F.; Vitolo, M.
abstract

: The medical approach to atrial fibrillation (AF) underwent a paradigm shift over time, evolving from considering AF as a simple arrhythmic phenomenon to a complex nosological entity [...].

2023 - Patterns of oral anticoagulant use and outcomes in Asian patients with atrial fibrillation: a post-hoc analysis from the GLORIA-AF Registry [Articolo su rivista]
Romiti, Giulio Francesco; Corica, Bernadette; Proietti, Marco; Mei, Davide Antonio; Frydenlund, Juliane; Bisson, Arnaud; Boriani, Giuseppe; Olshansky, Brian; Chan, Yi-Hsin; Huisman, Menno V; Chao, Tze-Fan; Lip, Gregory Y H
abstract

Background: Previous studies suggested potential ethnic differences in the management and outcomes of atrial fibrillation (AF). We aim to analyse oral anticoagulant (OAC) prescription, discontinuation, and risk of adverse outcomes in Asian patients with AF, using data from a global prospective cohort study. Methods: From the GLORIA-AF Registry Phase II-III (November 2011-December 2014 for Phase II, and January 2014-December 2016 for Phase III), we analysed patients according to their self-reported ethnicity (Asian vs. non-Asian), as well as according to Asian subgroups (Chinese, Japanese, Korean and other Asian). Logistic regression was used to analyse OAC prescription, while the risk of OAC discontinuation and adverse outcomes were analysed through Cox-regression model. Our primary outcome was the composite of all-cause death and major adverse cardiovascular events (MACE). The original studies were registered with ClinicalTrials.gov, NCT01468701, NCT01671007, and NCT01937377. Findings: 34,421 patients were included (70.0 ± 10.5 years, 45.1% females, 6900 (20.0%) Asian: 3829 (55.5%) Chinese, 814 (11.8%) Japanese, 1964 (28.5%) Korean and 293 (4.2%) other Asian). Most of the Asian patients were recruited in Asia (n = 6701, 97.1%), while non-Asian patients were mainly recruited in Europe (n = 15,449, 56.1%) and North America (n = 8378, 30.4%). Compared to non-Asian individuals, prescription of OAC and non-vitamin K antagonist oral anticoagulant (NOAC) was lower in Asian patients (Odds Ratio [OR] and 95% Confidence Intervals (CI): 0.23 [0.22-0.25] and 0.66 [0.61-0.71], respectively), but higher in the Japanese subgroup. Asian ethnicity was also associated with higher risk of OAC discontinuation (Hazard Ratio [HR] and [95% CI]: 1.79 [1.67-1.92]), and lower risk of the primary composite outcome (HR [95% CI]: 0.86 [0.76-0.96]). Among the exploratory secondary outcomes, Asian ethnicity was associated with higher risks of thromboembolism and intracranial haemorrhage, and lower risk of major bleeding. Interpretation: Our results showed that Asian patients with AF showed suboptimal thromboembolic risk management and a specific risk profile of adverse outcomes; these differences may also reflect differences in country-specific factors. Ensuring integrated and appropriate treatment of these patients is crucial to improve their prognosis. Funding: The GLORIA-AF Registry was funded by Boehringer Ingelheim GmbH.

2023 - Performance of a multi-sensor implantable defibrillator algorithm for heart failure monitoring in the presence of atrial fibrillation [Articolo su rivista]
Boriani, G.; Bertini, M.; Manzo, M.; Calo, L.; Santini, L.; Savarese, G.; Dello Russo, A.; Santobuono, V. E.; Lavalle, C.; Viscusi, M.; Amellone, C.; Calvanese, R.; Santoro, A.; Rapacciuolo, A.; Ziacchi, M.; Arena, G.; Imberti, J. F.; Campari, M.; Valsecchi, S.; D'Onofrio, A.
abstract

AIMS: The HeartLogic Index combines data from multiple implantable cardioverter defibrillators (ICDs) sensors and has been shown to accurately stratify patients at risk of heart failure (HF) events. We evaluated and compared the performance of this algorithm during sinus rhythm and during long-lasting atrial fibrillation (AF). METHODS AND RESULTS: HeartLogic was activated in 568 ICD patients from 26 centres. We found periods of ≥30 consecutive days with an atrial high-rate episode (AHRE) burden <1 h/day and periods with an AHRE burden ≥20 h/day. We then identified patients who met both criteria during the follow-up (AHRE group, n = 53), to allow pairwise comparison of periods. For control purposes, we identified patients with an AHRE burden <1 h throughout their follow-up and implemented 2:1 propensity score matching vs. the AHRE group (matched non-AHRE group, n = 106). In the AHRE group, the rate of alerts was 1.2 [95% confidence interval (CI): 1.0-1.5]/patient-year during periods with an AHRE burden <1 h/day and 2.0 (95% CI: 1.5-2.6)/patient-year during periods with an AHRE-burden ≥20 h/day (P = 0.004). The rate of HF hospitalizations was 0.34 (95% CI: 0.15-0.69)/patient-year during IN-alert periods and 0.06 (95% CI: 0.02-0.14)/patient-year during OUT-of-alert periods (P < 0.001). The IN/OUT-of-alert state incidence rate ratio of HF hospitalizations was 8.59 (95% CI: 1.67-55.31) during periods with an AHRE burden <1 h/day and 2.70 (95% CI: 1.01-28.33) during periods with an AHRE burden ≥20 h/day. In the matched non-AHRE group, the rate of HF hospitalizations was 0.29 (95% CI: 0.12-0.60)/patient-year during IN-alert periods and 0.04 (95% CI: 0.02-0.08)/patient-year during OUT-of-alert periods (P < 0.001). The incidence rate ratio was 7.11 (95% CI: 2.19-22.44). CONCLUSION: Patients received more alerts during periods of AF. The ability of the algorithm to identify increased risk of HF events was confirmed during AF, despite a lower IN/OUT-of-alert incidence rate ratio in comparison with non-AF periods and non-AF patients. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov/Identifier: NCT02275637.

2023 - Predicting all-cause mortality by means of a multisensor implantable defibrillator algorithm for heart failure monitoring [Articolo su rivista]
D'Onofrio, A.; Vitulano, G.; Calo, L.; Bertini, M.; Santini, L.; Savarese, G.; Dello Russo, A.; Santobuono, V. E.; Lavalle, C.; Viscusi, M.; Amellone, C.; Calvanese, R.; Santoro, A.; Ziacchi, M.; Palmisano, P.; Pisano, E.; Bianchi, V.; Tavoletta, V.; Campari, M.; Valsecchi, S.; Boriani, G.
abstract

Background: The HeartLogic algorithm (Boston Scientific) has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation. Objective: The purpose of this study was to determine whether remotely monitored data from this algorithm could be used to identify patients at high risk for mortality. Methods: The algorithm combines implantable cardioverter-defibrillator (ICD)–measured accelerometer-based heart sounds, intrathoracic impedance, respiration rate, ratio of respiration rate to tidal volume, night heart rate, and patient activity into a single index. An alert is issued when the index crosses a programmable threshold. The feature was activated in 568 ICD patients from 26 centers. Results: During median follow-up of 26 months [25th–75th percentile 16–37], 1200 alerts were recorded in 370 patients (65%). Overall, the time IN-alert state was 13% of the total observation period (151/1159 years) and 20% of the follow-up period of the 370 patients with alerts. During follow-up, 55 patients died (46 in the group with alerts). The rate of death was 0.25 per patient-year (95% confidence interval [CI] 0.17–0.34) IN-alert state and 0.02 per patient-year (95% CI 0.01–0.03) OUT of the alert state, with an incidence rate ratio of 13.72 (95% CI 7.62–25.60; P <.001). After multivariate correction for baseline confounders (age, ischemic cardiomyopathy, kidney disease, atrial fibrillation), the IN-alert state remained significantly associated with the occurrence of death (hazard ratio 9.18; 95% CI 5.27–15.99; P <.001). Conclusion: The HeartLogic algorithm provides an index that can be used to identify patients at higher risk for all-cause mortality. The index state identifies periods of significantly increased risk of death.

2023 - Prepare our healthcare systems to manage complexity: the case of atrial fibrillation [Articolo su rivista]
Mei, D. A.; Romiti, G. F.; Boriani, G.
abstract

2023 - Prevention, diagnosis and treatment of cardiac implantable electronic device infections. Position paper of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) [Articolo su rivista]
Pisano, E. C.; Mitacchione, G.; Pappalardo, A.; Di Grazia, A.; Solimene, F.; Boriani, G.; Migliore, F.; Curnis, A.
abstract

The number of cardiac implantable electronic device (CIED) implantations has increased over recent years as a result of population growth, increasing life expectancy, adoption of guidelines, and better access to healthcare. Device-related infection is, however, one of the most serious complications of CIED therapy associated with significant morbidity, mortality, and financial healthcare burden. Although many preventive strategies such as administration of intravenous antibiotic therapy before implantation are well recognized, uncertainties still exist about other regimens. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. The key aspect to successful treatment of definite CIED infections is complete removal of all parts of the system and transvenous hardware, including the device and all leads. Thus, transvenous lead extraction has been increasing. Expert consensus statements on how to prevent, diagnose, and treat CIED infections and on lead extraction have been published by the European Heart Rhythm Association in 2020 and 2018, respectively. The aim of this AIAC position paper is to describe the current knowledge on the risks for device-related infections and to assist healthcare professionals in their clinical decision making regarding its prevention, diagnosis, and management by providing the latest update of the most effective strategies.

2023 - Prevention, diagnosis and treatment of implantable electronic cardiac device infections. Position paper of the Italian Association of Arrhythmology and Cardiostimulation (AIAC) [Articolo su rivista]
Pisano, Ec; Mitacchione, G; Pappalardo, A; Di Grazia, A; Solimene, F; Boriani, G; Migliore, F; Curnis, A
abstract

The number of cardiac implantable electronic device (CIED) implantations has increased over recent years as a result of population growth, increasing life expectancy, adoption of guidelines, and better access to healthcare. Device-related infection is, however, one of the most serious complications of CIED therapy associated with significant morbidity, mortality, and financial healthcare burden. Although many preventive strategies such as administration of intravenous antibiotic therapy before implantation are well recognized, uncertainties still exist about other regimens. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. The key aspect to successful treatment of definite CIED infections is complete removal of all parts of the system and transvenous hardware, including the device and all leads. Thus, transvenous lead extraction has been increasing. Expert consensus statements on how to prevent, diagnose, and treat CIED infections and on lead extraction have been published by the European Heart Rhythm Association in 2020 and 2018, respectively. The aim of this AIAC position paper is to describe the current knowledge on the risks for device-related infections and to assist healthcare professionals in their clinical decision making regarding its prevention, diagnosis, and management by providing the latest update of the most effective strategies.

2023 - Progression of Atrial Fibrillation after Cryoablation [Articolo su rivista]
Boriani, G.; Imberti, J. F.; Vitolo, M.
abstract

To the Editor: Andrade et al. (Jan. 12 issue)(1) found that an initial strategy of catheter cryoballoon ablation in patients with paroxysmal atrial fibrillation was associated with a lower incidence of persistent atrial fibrillation, and a lower burden of arrhythmia than therapy with antiarrhythmic drugs during 3 years of follow-up. The article extends the initial findings of the Early Aggressive Invasive Intervention for Atrial Fibrillation (EARLY-AF) trial.(2) Given the number of participants (303 patients) and the relatively short follow-up, it would have been difficult to detect mortality benefits of cryoballoon ablation. Both the EARLY-AF and the STOP AF First(3) trials . . .

2023 - Quantification of Myocardial Contraction Fraction with Three-Dimensional Automated, Machine-Learning-Based Left-Heart-Chamber Metrics: Diagnostic Utility in Hypertrophic Phenotypes and Normal Ejection Fraction [Articolo su rivista]
Barbieri, A.; Imberti, J. F.; Bartolomei, M.; Bonini, N.; Laus, V.; Torlai Triglia, L.; Chiusolo, S.; Stuani, M.; Mari, C.; Muto, F.; Righelli, I.; Gerra, L.; Malaguti, M.; Mei, D. A.; Vitolo, M.; Boriani, G.
abstract

Aims: The differentiation of left ventricular (LV) hypertrophic phenotypes is challenging in patients with normal ejection fraction (EF). The myocardial contraction fraction (MCF) is a simple dimensionless index useful for specifically identifying cardiac amyloidosis (CA) and hypertrophic cardiomyopathy (HCM) when calculated by cardiac magnetic resonance. The purpose of this study was to evaluate the value of MCF measured by three-dimensional automated, machine-learning-based LV chamber metrics (dynamic heart model [DHM]) for the discrimination of different forms of hypertrophic phenotypes. Methods and Results: We analyzed the DHM LV metrics of patients with CA (n = 10), hypertrophic cardiomyopathy (HCM, n = 36), isolated hypertension (IH, n = 87), and 54 healthy controls. MCF was calculated by dividing LV stroke volume by LV myocardial volume. Compared with controls (median 61.95%, interquartile range 55.43–67.79%), mean values for MCF were significantly reduced in HCM—48.55% (43.46–54.86% p < 0.001)—and CA—40.92% (36.68–46.84% p < 0.002)—but not in IH—59.35% (53.22–64.93% p < 0.7). MCF showed a weak correlation with EF in the overall cohort (R2 = 0.136) and the four study subgroups (healthy adults, R2 = 0.039 IH, R2 = 0.089; HCM, R2 = 0.225; CA, R2 = 0.102). ROC analyses showed that MCF could differentiate between healthy adults and HCM (sensitivity 75.9%, specificity 77.8%, AUC 0.814) and between healthy adults and CA (sensitivity 87.0%, specificity 100%, AUC 0.959). The best cut-off values were 55.3% and 52.8%. Conclusions: The easily derived quantification of MCF by DHM can refine our echocardiographic discrimination capacity in patients with hypertrophic phenotype and normal EF. It should be added to the diagnostic workup of these patients.

2023 - Quantitative flow ratio-based outcomes in patients undergoing transcatheter aortic valve implantation quaestio study [Articolo su rivista]
Demola, P.; Colaiori, I.; Bosi, D.; Musto D'Amore, S.; Vitolo, M.; Benatti, G.; Vignali, L.; Tadonio, I.; Gabbieri, D.; Losi, L.; Magnavacchi, P.; Sgura, F. A.; Boriani, G.; Guiducci, V.
abstract

Background: Coronary artery disease (CAD) is common in patients with aortic valve stenosis (AS) ranging from 60% to 80%. The clinical and prognostic role of coronary artery lesions in patients undergoing Transcatheter Aortic Valve Implantation (TAVI) remains unclear. The aim of the present observational study was to estimate long-term clinical outcomes by Quantitative Flow Ratio (QFR) characterization of CAD in a well-represented cohort of patients affected by severe AS treated by TAVI. Methods: A total of 439 invasive coronary angiographies of patients deemed eligible for TAVI by local Heart Teams with symptomatic severe AS were retrospectively screened for QFR analysis. The primary endpoint of the study was all-cause mortality. The secondary endpoint was a composite of cardiovascular mortality, stroke/transient ischemic attack (TIA), acute myocardial infarction (AMI), and any hospitalization after TAVI. Results: After exclusion of patients with no follow-up data, coronary angiography not feasible for QFR analysis and previous surgical myocardial revascularization (CABG) 48/239 (20.1%) patients had a QFR value lower or equal to 0.80 (QFR + value), while the remaining 191/239 (79.9%) did not present any vessel with a QFR positive value. In the adjusted Cox regression analysis, patients with positive QFR were independently associated with an increased risk of all-casual mortality (Model 1, HR 3.47, 95% CI, 2.35−5.12; Model 2, HR 5.01, 95% CI, 3.17−7.90). In the adjusted covariate analysis, QFR+ involving LAD (37/48, 77,1%) was associated with the higher risk of the composite outcome compared to patients without any positive value of QFR or non-LAD QFR positive value (11/48, 22.9%). Conclusions: Pre-TAVI QFR analysis can be used for a safe, simple, wireless functional assessment of CAD. QFR permits to identify patients at high risk of cardiovascular mortality or MACE, and it could be considered by local Heart Teams.

2023 - REducing INFectiOns thRough Cardiac device Envelope: insight from real world data. The REINFORCE Project [Articolo su rivista]
Ziacchi, Matteo; Biffi, Mauro; Iacopino, Saverio; di Silvestro, Michele; Marchese, Procolo; Miscio, Francesca; Caccavo, Vincenzo Paolo; Zanotto, Gabriele; Tomasi, Luca; Dello Russo, Antonio; Donazzan, Luca; Boriani, Giuseppe
abstract

Background: Infections resulting from cardiac implantable electronic device (CIED) implantation are severely impacting on patients' and on health care systems. The use of TYRXTM absorbable antibiotic-eluting envelope has proven to decrease major CIED infections within 12 months of CIED surgery. Aims: to evaluate the impact of the envelope use on infection-related clinical events in a real-world contemporary patient population. Methods: Data on patients undergoing CIED surgery were collected prospectively by participating centers of the One Hospital ClinicalService project. Patients were divided into two groups according to whether TYRXTM absorbable antibiotic-eluting envelope was used or not. Results: Out of 1819 patients, 872 (47.9%) were implanted with an absorbable antibiotic-eluting envelope and included in the Envelope group and 947 (52.1%) patients who did not receive an envelope were included in the Control group. Compared to control, patients in the Envelope group had higher thrombo-embolic or hemorrhagic risk, higher BMI, lower LVEF and more comorbidities. During a mean follow-up of 1.4 years, the incidence of infection-related events was significantly higher in the control compared to the Envelope group (2.4% vs 0.8%, p = 0.007). The 5-year cumulative incidence of infection-related events was 8.1% in the control and 2.1% in the Envelope group (HR: 0.34, 95%CI: 0.14-0.80, p = 0.010). Conclusions: In our analysis, the use of an absorbable antibiotic-eluting envelope in the general CIED population was associated with a lower risk of systemic and pocket infection.

2023 - Radar-Based Monitoring of Vital Signs: A Tutorial Overview [Articolo su rivista]
Paterniani, G; Sgreccia, D; Davoli, A; Guerzoni, G; Di Viesti, P; Valenti, Ac; Vitolo, M; Vitetta, Gm; Boriani, G
abstract

In the last years, substantial attention has been paid to the use of radar systems in health monitoring, due to the availability of both low-cost radar devices and computationally efficient algorithms for processing their measurements. In this article, a tutorial overview of radar-based monitoring of vital signs is provided. More specifically, we first focus on the available radar technologies and the signal processing algorithms developed for the estimation of vital signs. Then, we provide some useful guidelines that should be followed in the selection of radar devices for vital sign monitoring and in their use. Finally, we illustrate various specific applications of radar systems to health monitoring and some relevant research trends in this field.

2023 - Real-world utilization of the pill-in-the-pocket method for terminating episodes of atrial fibrillation: data from the multinational Antiarrhythmic Interventions for Managing Atrial Fibrillation (AIM-AF) survey [Articolo su rivista]
Reiffel, J. A.; Blomstrom-Lundqvist, C.; Boriani, G.; Goette, A.; Kowey, P. R.; Merino, J. L.; Piccini, J. P.; Saksena, S.; Camm, A. J.
abstract

AIMS: Atrial fibrillation (AF) is the most common sustained arrhythmia encountered in clinical practice. Episodes may stop spontaneously (paroxysmal AF); may terminate only via intervention (persistent AF); or may persist indefinitely (permanent AF) (see European and American guidelines, referenced below, for more precise definitions). Recently, there has been renewed interest in an approach to terminate AF acutely referred to as 'pill-in-the-pocket' (PITP). The PITP is recognized in both the US and European guidelines as an effective option using an oral antiarrhythmic drug for acute conversion of acute/recent-onset AF. However, how PITP is currently used has not been systematically evaluated. METHODS AND RESULTS: The recently published Antiarrhythmic Interventions for Managing Atrial Fibrillation (AIM-AF) survey included questions regarding current PITP usage, stratified by US vs. European countries surveyed, by representative countries within Europe, and by cardiologists vs. electrophysiologists. This manuscript presents the data from this planned sub-study. Our survey revealed that clinicians in both the USA and Europe consider PITP in about a quarter of their patients, mostly for recent-onset AF with minimal or no structural heart disease (guideline appropriate). However, significant deviations exist. See the Graphical abstract for a summary of the data. CONCLUSION: Our findings highlight the frequent use of PITP and the need for further physician education about appropriate and optimal use of this strategy.

2023 - Remote monitoring of cardiac implantable electronic devices: from data to clinical actions [Articolo su rivista]
Imberti, Jacopo F; Vitolo, Marco; Boriani, Giuseppe
abstract

2023 - Remote multiparametric monitoring and management of heart failure patients through cardiac implantable electronic devices [Articolo su rivista]
Boriani, G.; Imberti, J. F.; Bonini, N.; Carriere, C.; Mei, D. A.; Zecchin, M.; Piccinin, F.; Vitolo, M.; Sinagra, G.
abstract

In this review we focus on heart failure (HF) which, as known, is associated with a substantial risk of hospitalizations and adverse cardiovascular outcomes, including death. In recent years, systems to monitor cardiac function and patient parameters have been developed with the aim to detect subclinical pathophysiological changes that precede worsening HF. Several patient-specific parameters can be remotely monitored through cardiac implantable electronic devices (CIED) and can be combined in multiparametric scores predicting patients’ risk of worsening HF with good sensitivity and moderate specificity. Early patient management at the time of pre-clinical alerts remotely transmitted by CIEDs to physicians might prevent hospitalizations. However, it is not clear yet which is the best diagnostic pathway for HF patients after a CIED alert, which kind of medications should be changed or escalated, and in which case in-hospital visits or in-hospital admissions are required. Finally, the specific role of healthcare professionals involved in HF patient management under remote monitoring is still matter of definition. We analyzed recent data on multiparametric monitoring of patients with HF through CIEDs. We provided practical insights on how to timely manage CIED alarms with the aim to prevent worsening HF. We also discussed the role of biomarkers and thoracic echo in this context, and potential organizational models including multidisciplinary teams for remote care of HF patients with CIEDs.

2023 - Run baby run … but not too fast! Rate control management in atrial fibrillation: a claim for personalization [Articolo su rivista]
Diemberger, I.; Boriani, G.
abstract

2023 - Screening for atrial fibrillation: different approaches targeted to reduce ischemic stroke [Articolo su rivista]
Boriani, Giuseppe; Imberti, Jacopo F; Vitolo, Marco
abstract

2023 - Searching for atrial fibrillation: looking harder, looking longer, and in increasingly sophisticated ways. An EHRA position paper' [Articolo su rivista]
Kalarus, Zbigniew; Mairesse, Georges H; Sokal, Adam; Boriani, Giuseppe; Średniawa, Beata; Arroyo, Ruben Casado; Wachter, Rolf; Frommeyer, Gerrit; Traykov, Vassil; Dagres, Nikolaos; Lip, Gregory Y H; Boersma, Lucas; Peichl, Petr; Dobrev, Dobromir; Bulava, Alan; Blomström-Lundqvist, Carina; de Groot, Natasja M S; Schnabel, Renate; Heinzel, Frank; Van Gelder, Isabelle C; Carbuccichio, Corrado; Shah, Dipen; Eckardt, Lars
abstract

2023 - Short and long-term outcomes after cardiac surgery in Jehovah's Witnesses patients: a case-control study [Articolo su rivista]
Nanni, Giulia; Vitolo, Marco; Imberti, Jacopo F; Girolami, Denise; Bonini, Niccolò; Valenti, Anna Chiara; Cimato, Paolo; Boriani, Giuseppe
abstract

Cardiac surgery in Jehovah's Witnesses (JW) patients who refuse blood transfusion is challenging requiring dedicated strategies. We aimed to analyze non-selected JW patients undergoing cardiac surgery and to compare with matched controls both perioperative outcomes and long-term survival. We retrospectively analyzed JW patients undergoing cardiac surgery from January 2016 to March 2021 and compared them with matched controls. The primary outcome was a composite of in-hospital perioperative adverse events and in-hospital mortality. The secondary outcome was all-cause mortality at long-term follow-up. A total of 113 JW patients and 113 controls were included. Baseline clinical characteristics, including laboratory parameters were comparable. Overall, there were no statistical differences between JW vs controls in terms of in-hospital mortality (2.7% vs 1.8%, p = 1.00) but mortality was remarkably high (40%) in JW patients with post-op hemoglobin < 8 g/dl. Logistic regression analysis found that the JW group was not associated with a higher occurrence of the composite outcome (adjusted odds ratio 0.91, 95% confidence interval [CI] 0.54-1.57). After a median follow-up of 1397 [IQR 922.7-1723.5] days, JW patients were not associated with a significantly higher all-cause mortality (adjusted hazard ratio 0.77, 95% CI 0.24-2.42). Cardiac surgery can be safely performed in non-anemic JW patients despite the refusal of blood transfusions. Favorable clinical outcomes can be achieved by the use of specific perioperative strategies for bloodless surgery with no differences as compared to control patients except in JW patients with a very low level of post-operative hemoglobin not supported by immediate transfusions.

2023 - Single-lead VDD pacing: a literature review on short-term and long-term performance [Articolo su rivista]
Mei, Davide Antonio; Imberti, Jacopo Francesco; Vitolo, Marco; Bonini, Niccolò; Gerra, Luigi; Romiti, Giulio Francesco; Proietti, Marco; Lip, Gregory Y H; Boriani, Giuseppe
abstract

IntroductionVDD pacing system was introduced more than 30 years ago. Its use is considered by the 2021 European Society of Cardiology guidelines on cardiac pacing as a potential alternative to dual chambers system for patients with atrioventricular block and normal sinus node function.Areas coveredIn this article, we performed a narrative review of current literature in order to identify the strengths and weaknesses of this pacing system. VDD system allows the maintenance of AV synchronous pacing and its hemodynamic advantages. Some disadvantages may be related to the non-negligible incidence of atrial undersensing and the possible subsequent need for upgrade to DDD system. On the other hand, shorter implantation time and lower complications rate may be advantages.Expert opinionIn the modern pacing era, VDD pacing system struggles to find its own space. However, it may still be considered as a valuable alternative to a dual-chamber pacemaker for selected patients, in specific clinical scenarios.

2023 - Smartphone-based cardiac implantable electronic device remote monitoring: improved compliance and connectivity [Articolo su rivista]
Manyam, H.; Burri, H.; Casado-Arroyo, R.; Varma, N.; Lennerz, C.; Klug, D.; Carr-White, G.; Kolli, K.; Reyes, I.; Nabutovsky, Y.; Boriani, G.
abstract

Aims: Remote monitoring (RM) is the standard of care for follow up of patients with cardiac implantable electronic devices. The aim of this study was to compare smartphone-based RM (SM-RM) using patient applications (myMerlinPulse™ app) with traditional bedside monitor RM (BM-RM). Methods and results: The retrospective study included de-identified US patients who received either SM-RM or BM-RM capable of implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators (Abbott, USA). Patients in SM-RM and BM-RM groups were propensity-score matched on age and gender, device type, implant year, and month. Compliance with RM was quantified as the proportion of patients enrolling in the RM system (Merlin.net™) and transmitting data at least once. Connectivity was measured by the median number of days between consecutive transmissions per patient. Of the initial 9714 patients with SM-RM and 26 679 patients with BM-RM, 9397 patients from each group were matched. Remote monitoring compliance was higher in SM-RM; significantly more patients with SM-RM were enrolled in RM compared with BM-RM (94.4 vs. 85.0%, P < 0.001), similar number of patients in the SM-RM group paired their device (95.1 vs. 95.0%, P = 0.77), but more SM-RM patients transmitted at least once (98.1 vs. 94.3%, P < 0.001). Connectivity was significantly higher in the SM-RM, with patients transmitting data every 1.2 (1.1, 1.7) vs. every 1.7 (1.5, 2.0) days with BM-RM (P < 0.001) and remained better over time. Significantly more SM-RM patients utilized patient-initiated transmissions compared with BM-RM (55.6 vs. 28.1%, P < 0.001). Conclusion: In this large real-world study, patients with SM-RM demonstrated improved compliance and connectivity compared with BM-RM.

2023 - The Importance of Mehran Score to Predict Acute Kidney Injury in Patients with TAVI: A Large Multicenter Cohort Study [Articolo su rivista]
Arrotti, S.; Sgura, F. A.; Monopoli, D. E.; Siena, V.; Leo, G.; Morgante, V.; Cataldo, P.; Magnavacchi, P.; Gabbieri, D.; Guiducci, V.; Benatti, G.; Vignali, L.; Boriani, G.; Rossi, R.
abstract

Background: Transcatheter aortic valve implantation (TAVI) has developed as an alternative to surgery for symptomatic high-risk patients with aortic stenosis (AS). An important complication of TAVI is acute kidney injury. The purpose of the study was to investigate if the Mehran Score (MS) could be used to predict acute kidney injury (AKI) in TAVI patients. Methods: This is a multicenter, retrospective, observational study including 1180 patients with severe AS. The MS comprised eight clinical and procedural variables: hypotension, congestive heart failure class, glomerular filtration rate, diabetes, age >75 years, anemia, need for intra-aortic balloon pump, and contrast agent volume use. We assessed the sensitivity and specificity of the MS in predicting AKI following TAVI, as well as the predictive value of MS with each AKI-related characteristic. Results: Patients were categorized into four risk groups based on MS: low (≤5), moderate (6–10), high (11–15), and very high (≥16). Post-procedural AKI was observed in 139 patients (11.8%). MS classes had a higher risk of AKI in the multivariate analysis (HR 1.38, 95% CI, 1.43–1.63, p < 0.01). The best cutoff for MS to predict the onset of AKI was 13.0 (AUC, 0.62; 95% CI, 0.57–0.67), whereas the best cutoff for eGFR was 42.0 mL/min/1.73 m2 (AUC, 0.61; 95% CI, 0.56–0.67). Conclusions: MS was shown to be a predictor of AKI development in TAVI patients.

2023 - The burden of atrial fibrillation in patients with preserved or mildly reduced heart failure: a call to action for detecting atrial fibrillation and improving outcome [Articolo su rivista]
Boriani, G.; Imberti, J. F.; Vitolo, M.
abstract

2023 - The epidemiology and mortality of patients with atrial fibrillation: a complex landscape [Articolo su rivista]
Boriani, Giuseppe; Bonini, Niccolò; Imberti, Jacopo Francesco
abstract

2023 - Therapeutic effects of sodium–glucose cotransporter 2 inhibitors in patients with heart failure with preserved ejection fraction: From outcome improvement to potentially favourable influences on atrial fibrillation burden, atrial fibrillation progression and atrial cardiomyopathy [Articolo su rivista]
Boriani, G.; Mei, D. A.; Imberti, J. F.
abstract

2023 - Timing of cardiac resynchronization therapy implantation [Articolo su rivista]
Leyva, F.; Zegard, A.; Patel, P.; Stegemann, B.; Marshall, H.; Ludman, P.; Walton, J.; de Bono, J.; Boriani, G.; Qiu, T.
abstract

Aims The optimum timing of cardiac resynchronization therapy (CRT) implantation is unknown. We explored long-term outcomes after CRT in relation to the time interval from a first heart failure hospitalization (HFH) to device implantation. .Methods A database covering the population of England (56.3 million in 2019) was used to quantify clinical outcomes after CRT im- and results plantation in relation to first HFHs. From 2010 to 2019, 64 968 patients [age: 71.4 ± 11.7 years; 48 606 (74.8%) male] underwent CRT implantation, 57% in the absence of a previous HFH, 12.9% during the first HFH, and 30.1% after ≥1 HFH. Over 4.54 (2.80–6.71) years [median (interquartile range); 272 989 person-years], the time in years from the first HFH to CRT implantation was associated with a higher risk of total mortality [hazard ratio (HR); 95% confidence intervals (95% CI)] (1.15; 95% CI 1.14–1.16, HFH (HR: 1.26; 95% CI 1.24–1.28), and the combined endpoint of total mortality or HFH (HR: 1.19; 95% CI 1.27–1.20) than CRT in patients with no previous HFHs, after co-variate adjustment. Total mortality (HR: 1.67), HFH (HR: 2.63), and total mortality or HFH (HR: 1.92) (all P < 0.001) were highest in patients undergoing CRT ≥2 years after the first HFH. Conclusion In this study of a healthcare system covering an entire nation, delays from a first HFH to CRT implantation were associated with progressively worse long-term clinical outcomes. The best clinical outcomes were observed in patients with no previous HFH and in those undergoing CRT implantation during the first HFH. Condensed The optimum timing of CRT implantation is unknown. In this study of 64 968 consecutive patients, delays from a first heart abstract failure hospitalization (HFH) to CRT implantation were associated with progressively worse long-term clinical outcomes. Each year from a first HFH to CRT implantation was associated with a 21% higher risk of total mortality and a 34% higher risk of HFH. The best outcomes after CRT were observed in patients with no previous HFHs and in those undergoing implantation during their first HFH. The left upper panel shows the timing (y-axis) and numbers (x-axis) of cardiac resynchronization therapy (CRT) implantations in relation to the timing of first heart failure hospitalizations (HFHs); the right upper panel shows CRT implantations undertaken during a first HFH as a percentage of all implantations, according to year. Patients were regarded as not having had a HFH if this had not occurred within 5 years prior to CRT implantation. The left lower panel shows the Kaplan–Meier survival curve for total mortality. Event rates (per 100 person-years) for the three endpoints according to the timing of CRT implantation in relation to a first HFH are shown in the right lower panel.

2023 - Use of Diltiazem in Chronic Rate Control for Atrial Fibrillation: A Prospective Case-Control Study [Articolo su rivista]
Diemberger, I.; Spadotto, A.; Massaro, G.; Amadori, M.; Damaschin, L.; Martignani, C.; Ziacchi, M.; Biffi, M.; Galie, N.; Boriani, G.
abstract

Atrial fibrillation (AF) is a multifaceted disease requiring personalised treatment. The aim of our study was to explore the prognostic impact of a patient-specific therapy (PT) for rate control, including the use of non-dihydropyridine calcium channel blockers (NDDC) in patients with heart failure (HF) or in combination with beta-blockers (BB), compared to standard rate control therapy (ST), as defined by previous ESC guidelines. This is a single-centre prospective observational registry on AF patients who were followed by our University Hospital. We included 1112 patients on an exclusive rate control treatment. The PT group consisted of 125 (11.2%) patients, 93/125 (74.4%) of whom were prescribed BB + NDCC (±digoxin), while 85/125 (68.0%) were HF patients who were prescribed NDCC, which was diltiazem in all cases. The patients treated with a PT showed no difference in one-year overall survival compared to those with an ST. Notably, the patients with HF in ST had a worse prognosis (p < 0.001). To better define this finding, we performed three sensitivity analyses by matching each patient in the PT subgroups with three subjects from the ST cohort, showing an improved one-year survival of the HF patients treated with PT (p = 0.039). Our results suggest a potential outcome benefit of NDCC for rate control in AF patients, either alone or in combination with BB and in selected patients with HF.

2023 - Yield of diagnosis and risk of stroke with screening strategies for atrial fibrillation: a comprehensive review of current evidence [Articolo su rivista]
Corica, B.; Bonini, N.; Imberti, J. F.; Romiti, G. F.; Vitolo, M.; Attanasio, L.; Basili, S.; Freedman, B.; Potpara, T. S.; Boriani, G.; Lip, G. Y. H.; Proietti, M.
abstract

Atrial fibrillation (AF) is the most prevalent arrhythmia worldwide. The presence of AF is associated with increased risk of systemic thromboembolism, but with the uptake of oral anticoagulant (OAC) and implementation of a holistic and integrated care management, this risk is substantially reduced. The diagnosis of AF requires a 30-s-long electrocardiographic (ECG) trace, irrespective of the presence of symptoms, which may represent the main indication for an ECG tracing. However, almost half patients are asymptomatic at the time of incidental AF diagnosis, with similar risk of stroke of those with clinical AF. This has led to a crucial role of screening for AF, to increase the diagnosis of population at risk of clinical events. The aim of this review is to give a comprehensive overview about the epidemiology of asymptomatic AF, the different screening technologies, the yield of diagnosis in asymptomatic population, and the benefit derived from screening in terms of reduction of clinical adverse events, such as stroke, cardiovascular, and all-cause death. We aim to underline the importance of implementing AF screening programmes and reporting about the debate between scientific societies’ clinical guidelines recommendations and the concerns expressed by the regulatory authorities, which still do not recommend population-wide screening. This review summarizes data on the ongoing trials specifically designed to investigate the benefit of screening in terms of risk of adverse events which will further elucidate the importance of screening in reducing risk of outcomes and influence and inform clinical practice in the next future.

2022 - 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy Developed by the Task Force on cardiac pacing and cardiac resynchronization therapy of the European Society of Cardiology (ESC) With the special contribution of the European Heart Rhythm Association (EHRA) [Articolo su rivista]
Glikson, Michael; Nielsen, Jens Cosedis; Kronborg, Mads Brix; Michowitz, Yoav; Auricchio, Angelo; Barbash, Israel Moshe; Barrabés, José A; Boriani, Giuseppe; Braunschweig, Frieder; Brignole, Michele; Burri, Haran; Coats, Andrew J S; Deharo, Jean-Claude; Delgado, Victoria; Diller, Gerhard-Paul; Israel, Carsten W; Keren, Andre; Knops, Reinoud E; Kotecha, Dipak; Leclercq, Christophe; Merkely, Béla; Starck, Christoph; Thylén, Ingela; Tolosana, José Maria
abstract

2022 - 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy Developed by the Task Force on cardiac pacing and cardiac resynchronization therapy of the European Society of Cardiology (ESC) With the special contribution of the European Heart Rhythm Association (EHRA) [Articolo su rivista]
Glikson, M.; Nielsen, J. C.; Kronborg, M. B.; Michowitz, Y.; Auricchio, A.; Barbash, I. M.; Barrabes, J. A.; Boriani, G.; Braunschweig, F.; Brignole, M.; Burri, H.; Coats, A. J. S.; Deharo, J. -C.; Delgado, V.; Diller, G. -P.; Israel, C. W.; Keren, A.; Knops, R. E.; Kotecha, D.; Leclercq, C.; Merkely, B.; Starck, C.; Thylen, I.; Tolosana, J. M.
abstract

2022 - 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: Developed by the Task Force on cardiac pacing and cardiac resynchronization therapy of the European Society of Cardiology (ESC) With the special contribution of the European Heart Rhythm Association (EHRA) [Articolo su rivista]
Glikson, M; Nielsen, Jc; Kronborg, Mb; Michowitz, Y; Auricchio, A; Barbash, Im; Barrabes, Ja; Boriani, G; Braunschweig, F; Brignole, M; Burri, H; Coats, Ajs; Deharo, Jc; Delgado, V; Diller, Gp; Israel, Cw; Keren, A; Knops, Re; Kotecha, D; Leclercq, C; Merkely, B; Starck, C; Thylen, I; Tolosana, Jm
abstract

2022 - 2022 ESC Guidelines for the management of ventricular arrhythmias and sudden cardiac death: an important focus on a multidisciplinary approach to a tailored diagnostic and therapeutic work-up|Linee guida europee 2022 su aritmie ventricolari e morte cardiaca improvvisa: un importante impulso a un impegno multidisciplinare in campo diagnostico e terapeutico per un’accurata personalizzazione dell’approccio clinico [Articolo su rivista]
Boriani, G.; Mei, D. A.; Vitolo, M.; Imberti, J. F.
abstract

2022 - 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS) [Articolo su rivista]
Lyon, Alexander R; López-Fernández, Teresa; Couch, Liam S; Asteggiano, Riccardo; Aznar, Marianne C; Bergler-Klein, Jutta; Boriani, Giuseppe; Cardinale, Daniela; Cordoba, Raul; Cosyns, Bernard; Cutter, David J; de Azambuja, Evandro; de Boer, Rudolf A; Dent, Susan F; Farmakis, Dimitrios; Gevaert, Sofie A; Gorog, Diana A; Herrmann, Joerg; Lenihan, Daniel; Moslehi, Javid; Moura, Brenda; Salinger, Sonja S; Stephens, Richard; Suter, Thomas M; Szmit, Sebastian; Tamargo, Juan; Thavendiranathan, Paaladinesh; Tocchetti, Carlo G; van der Meer, Peter; van der Pal, Helena J H
abstract

2022 - 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS) [Articolo su rivista]
Lyon, A. R.; Lopez-Fernandez, T.; Couch, L. S.; Asteggiano, R.; Aznar, M. C.; Bergler-Klein, J.; Boriani, G.; Cardinale, D.; Cordoba, R.; Cosyns, B.; Cutter, D. J.; de Azambuja, E.; de Boer, R. A.; Dent, S. F.; Farmakis, D.; Gevaert, S. A.; Gorog, D. A.; Herrmann, J.; Lenihan, D.; Moslehi, J.; Moura, B.; Salinger, S. S.; Stephens, R.; Suter, T. M.; Szmit, S.; Tamargo, J.; Thavendiranathan, P.; Tocchetti, C. G.; van der Meer, P.; van der Pal, H. J. H.; Lancellotti, P.; Thuny, F.; Abdelhamid, M.; Aboyans, V.; Aleman, B.; Alexandre, J.; Barac, A.; Borger, M. A.; Casado-Arroyo, R.; Cautela, J.; Celutkiene, J.; Cikes, M.; Cohen-Solal, A.; Dhiman, K.; Ederhy, S.; Edvardsen, T.; Fauchier, L.; Fradley, M.; Grapsa, J.; Halvorsen, S.; Heuser, M.; Humbert, M.; Jaarsma, T.; Kahan, T.; Konradi, A.; Koskinas, K. C.; Kotecha, D.; Ky, B.; Landmesser, U.; Lewis, B. S.; Linhart, A.; Lip, G. Y. H.; Lochen, M. -L.; Malaczynska-Rajpold, K.; Metra, M.; Mindham, R.; Moonen, M.; Neilan, T. G.; Nielsen, J. C.; Petronio, A. -S.; Prescott, E.; Rakisheva, A.; Salem, J. -E.; Savarese, G.; Sitges, M.; Ten Berg, J.; Touyz, R. M.; Tycinska, A.; Wilhelm, M.; Zamorano, J. L.
abstract

2022 - AIM-AF: A Physician Survey in the United States and Europe [Articolo su rivista]
Camm, A. J.; Blomstrom-Lundqvist, C.; Boriani, G.; Goette, A.; Kowey, P. R.; Merino, J. L.; Piccini, J. P.; Saksena, S.; Reiffel, J. A.
abstract

Background Guideline recommendations are the accepted reference for selection of therapies for rhythm control of atrial fibrillation (AF). This study was designed to understand physicians’ treatment practices and adherence to guidelines. Methods and Results The AIM-AF (Antiarrhythmic Medication for Atrial Fibrillation) study was an online survey of clinical cardiologists and electrophysiologists that was conducted in the United States and Europe (N=629). Respondents actively treated ≥30 patients with AF who received drug therapy, and had received or were referred for ablation every 3 months. The survey comprised 96 questions on physician demographics, AF types, and treatment practices. Overall, 54% of respondents considered guidelines to be the most important nonpatient factor influencing treatment choice. Across most queried comorbidities, amiodarone was selected by 60% to 80% of respondents. Other nonadherent usage included sotalol by 21% in patients with renal impairment; dofetilide initiation (16%, United States only) outside of hospital; class Ic agents by 6% in coronary artery disease; and dronedarone by 8% in patients with heart failure with reduced ejection fraction. Additionally, rhythm control strategies were frequently chosen in asymptomatic AF (antiarrhythmic drugs [AADs], 35%; ablation, 8%) and subclinical AF (AADs, 38%; ablation, 13%). Despite guideline algorithms emphasizing safety first, efficacy (48%) was selected as the most important consideration for AAD choice, followed by safety (34%). Conclusions Despite surveyed clinicians recognizing the importance of guidelines, nonadherence was frequently observed. While deviation may be reasonable in selected patients, in general, nonadherence has the potential to compromise patient safety. These findings highlight an underappreciation of the safe use of AADs, emphasizing the need for interventions to support optimal AAD selection.

2022 - Add-on Therapy With Sacubitril/Valsartan and Clinical Outcomes in CRT-D Nonresponder Patients [Articolo su rivista]
Russo, V.; Ammendola, E.; Gasperetti, A.; Bottino, R.; Schiavone, M.; Masarone, D.; Pacileo, G.; Nigro, G.; Golino, P.; Lip, G. Y. H.; D'andrea, A.; Boriani, G.; Proietti, R.
abstract

No data on the add-on sacubitril/valsartan (S/V) therapy among cardiac resynchronization therapy with a defibrillator (CRT-D) nonresponder patients are currently available in literature. We conducted a prospective observational study including 190 CRT-D nonresponder patients with symptomatic heart failure with reduced ejection fraction despite the optimal medical therapy from at least 1 year. The primary endpoint was the rate of additional responders (left ventricular end-systolic volume reduction >15%) at 12 months from the introduction of S/V therapy. At the end of the 12 months follow-up, 37 patients (19.5%) were deemed as "additional responders" to the combination use of CRT + S/V therapy. The only clinical predictor of additional response was a lower left ventricular ejection fraction [OR 0.881 (0.815-0.953), P = 0.002] at baseline. At 12 months follow-up, there were significant improvements in heart failure (HF) symptoms and functional status [New York Heart Association 2 (2-3) vs. 1 (1-2), P < 0.001; physical activity duration/day: 10 (8-12) vs. 13 (10-18) hours, P < 0.001]. Compared with the 12 months preceding S/V introduction, there were significant reductions in the rate of HF rehospitalization (35.5% vs. 19.5%, P < 0.001), in atrial tachycardia/atrial fibrillation burden [6.0 (5.0-8.0) % vs. 0 (0-2.0) %, P < 0.001] and in the proportions of patients experiencing ventricular arrhythmias (21.6% vs. 6.3%; P < 0.001). Our results indicate that S/V add-on therapy in CRT-D nonresponder patients is associated with 19.5% of additional responders, a reduction in HF symptoms and rehospitalizations, AF burden, and ventricular arrhythmias.

2022 - Adherence to the “Atrial fibrillation Better Care” (ABC) pathway in patients with atrial fibrillation and cancer: A report from the ESC-EHRA EURObservational Research Programme in atrial fibrillation (EORP-AF) General Long-Term Registry [Articolo su rivista]
Vitolo, M.; Proietti, M.; Malavasi, V. L.; Bonini, N.; Romiti, G. F.; Imberti, J. F.; Fauchier, L.; Marin, F.; Nabauer, M.; Potpara, T. S.; Dan, G. -A.; Kalarus, Z.; Maggioni, A. P.; Lane, D. A.; Lip, G. Y. H.; Boriani, G.; Boriani Chair, G.; Lip, G. Y. H.; Tavazzi, L.; Maggioni, A. P.; Dan, G. A.; Potpara, T.; Nabauer, M.; Marin, F.; Kalarus, Z.; Fauchier, L.; Goda, A.; Mairesse, G.; Shalganov, T.; Antoniades, L.; Taborsky, M.; Riahi, S.; Muda, P.; Bolao, I. G.; Piot, O.; Etsadashvili, K.; Simantirakis, E. N.; Haim, M.; Azhari, A.; Najafian, J.; Santini, M.; Mirrakhimov, E.; Kulzida, K.; Erglis, A.; Poposka, L.; Burg, M. R.; Crijns, H.; Erkuner, O.; Atar, D.; Lenarczyk, R.; Oliveira, M. M.; Shah, D.; Serdechnaya, E.; Dan, G. -A.; Diker, E.; Lane, D.
abstract

Background: Implementation of the Atrial fibrillation Better Care (ABC) pathway is recommended by guidelines on atrial fibrillation (AF), but the impact of adherence to ABC pathway in patients with cancer is unknown. Objectives: To investigate the adherence to ABC pathway and its impact on adverse outcomes in AF patients with cancer. Methods: Patients enrolled in the EORP-AF General Long-Term Registry were analyzed according to (i) No Cancer; and (ii) Prior or active cancer and stratified in relation to adherence to the ABC pathway. The composite Net Clinical Outcome (NCO) of all-cause death, major adverse cardiovascular events and major bleeding was the primary endpoint. Results: Among 6550 patients (median age 69 years, females 40.1%), 6005 (91.7%) had no cancer, while 545 (8.3%) had a diagnosis of active or prior cancer at baseline, with the proportions of full adherence to ABC pathway of 30.6% and 25.7%, respectively. Adherence to the ABC pathway was associated with a significantly lower occurrence of the primary outcome vs. non-adherence, both in ‘no cancer’ and ‘cancer’ patients [adjusted Hazard Ratio (aHR) 0.78, 95% confidence interval (CI): 0.66–0.92 and aHR 0.59, 95% CI 0.37–0.96, respectively]. Adherence to a higher number of ABC criteria was associated with a lower risk of the primary outcome, being lowest when 3 ABC criteria were fulfilled (no cancer: aHR 0.54, 95%CI: 0.36–0.81; with cancer: aHR 0.32, 95% CI 0.13–0.78). Conclusion: In AF patients with cancer enrolled in the EORP-AF General Long-Term Registry, adherence to ABC pathway was sub-optimal. Full adherence to ABC-pathway was associated with a lower risk of adverse events

2022 - Anthropometric parameters and radiation doses during percutaneous coronary procedures [Articolo su rivista]
Manicardi, Marcella; Nocetti, Luca; Brigidi, Alessio; Cadioli, Cecilia; Sgreccia, Daria; Valenti, Anna Chiara; Vitolo, Marco; Arrotti, Salvatore; Monopoli, Daniel Enrique; Sgura, Fabio; Rossi, Rosario; Guidi, Gabriele; Boriani, Giuseppe
abstract

Body size is a major determinant of patient's dose during percutaneous coronary interventions (PCI). Body mass index, body surface area (BSA), lean body mass and weight are commonly used estimates for body size. We aim to identify which of these measures and which procedural/clinical characteristics can better predict received dose.

2022 - Arrhythmias in COVID-19/SARS-CoV-2 Pneumonia Infection: Prevalence and Implication for Outcomes [Articolo su rivista]
Denegri, A.; Sola, M.; Morelli, M.; Farioli, F.; Alberto, T.; D'Arienzo, M.; Savorani, F.; Pezzuto, G. S.; Boriani, G.; Szarpak, L.; Magnani, G.
abstract

Arrhythmias (ARs) are potential cardiovascular complication of COVID-19 but may also have a prognostic role. The aim of this study was to explore the prevalence and impact of cardiac ARs in hospitalized COVID-19 patients. All-comer patients admitted to the emergency department of Modena University Hospital from 16 March to 31 December 2020 and diagnosed with COVID-19 pneumonia infection were included in the study. The primary endpoint was 30-day mortality. Out of 902 patients, 637 (70.6%) presented a baseline 12-lead ECG registration; of these, 122 (19.2%) were diagnosed with ARs. Atrial fibrillation (AF, 40.2%) was the most frequent AR detected. The primary endpoint (30-day mortality) occurred in 33.6% (p < 0.001). AR-patients presented an almost 3-fold risk of mortality compared to non-AR-patients at 30d (Adj. OR = 2.8, 95%CI: 1.8–4.3, p < 0.001). After adjustment for significant baseline characteristics selected by a stepwise backward selection, AR-patients remained at increased risk of mortality (Adj. HR = 2.0, 95%CI: 1.9–2.3, p < 0.001). Sub-group analysis revealed that among ARs patients, those with AF at admission presented the highest risk of 30-day mortality (Adj. HR = 3.1, 95%CI: 2.0–4.9, p < 0.001). In conclusion, ARs are a quite common manifestation in COVID-19 patients, who are burdened by even worse prognosis. AR patients with AF presented the highest risk of mortality; thus, these patients may benefit from a more aggressive secondary preventive therapy and a closer follow up.

2022 - Association Between Device-Detected Sleep-Disordered Breathing and Implantable Defibrillator Therapy in Patients With Heart Failure [Articolo su rivista]
Mazza, Andrea; Bendini, Maria Grazia; Bianchi, Valter; Esposito, Cristina; Calò, Leonardo; Andreoli, Chiara; Santobuono, Vincenzo Ezio; Dello Russo, Antonio; Viscusi, Miguel; La Greca, Carmelo; Baiocchi, Claudia; Talarico, Antonello; Albanese, Raimondo; Arena, Giuseppe; Giubilato, Giovanna; Ziacchi, Matteo; Rapacciuolo, Antonio; Campari, Monica; Valsecchi, Sergio; Boriani, Giuseppe
abstract

BACKGROUND Sleep-disordered breathing is highly prevalent in heart failure (HF) and has been suggested as a risk factor for malignant ventricular arrhythmias. The Respiratory Disturbance Index (RDI) computed by an implantable cardioverter-defibrillator (ICD) algorithm accurately identifies severe sleep apnea.OBJECTIVES In the present analysis, the authors evaluated the association between ICD-detected sleep apnea and the incidence of appropriate ICD therapies in patients with HF.METHODS We enrolled 411 HF patients who had received an ICD endowed with an algorithm that calculates the RDI each night. In this analysis, the weekly mean RDI value was considered. The endpoint was the first appropriate ICD shock.RESULTS The median follow-up was 26 months (25th to 75th percentile: 16-35 months). During follow-up, 1 or more ICD shocks were documented in 58 (14%) patients. Patients with shocks were younger (age 66 +/- 13 years vs 70 +/- 10 years; P = 0.038), and had more frequently undergone implantation for secondary prevention (21% vs 10%; P = 0.026). The maximum RDI value calculated during the entire follow-up period did not differ between patients with and without shocks (55 +/- 15 episodes/h vs 54 +/- 14 episodes/h; P = 0.539). However, the ICD-detected RDI showed considerable variability during follow-up. The overall median of the weekly RDI was 33 episodes/h (25th to 75th percentile: 24-45 episodes/h). A time-dependent Cox regression model revealed that a continuously measured weekly mean RDI of $45 episodes/h was independently associated with shock occurrence (HR: 4.63; 95% CI: 2.54-8.43; P < 0.001), after correction for baseline confounders (age, secondary prevention).CONCLUSIONS In HF patients, appropriate ICD shocks were more likely to be delivered during periods when patients exhibited more sleep-disordered breathing. (Arrhythmias Detection in a Real World Population [RHYTHM DETECT]; NCT02275637) (J Am Coll Cardiol EP 2022;8:1249-1256) (c) 2022 by the American College of Cardiology Foundation.

2022 - Association between implantable defibrillator-detected sleep apnea and atrial fibrillation: The DASAP-HF study [Articolo su rivista]
Boriani, G.; Diemberger, I.; Pisano, E. C. L.; Pieragnoli, P.; Locatelli, A.; Capucci, A.; Talarico, A.; Zecchin, M.; Rapacciuolo, A.; Piacenti, M.; Indolfi, C.; Arias, M. A.; Checchinato, C.; La Rovere, M. T.; Sinagra, G.; Emdin, M.; Ricci, R. P.; D'Onofrio, A.
abstract

Introduction: The Respiratory Disturbance Index (RDI) computed by an implantable cardioverter defibrillator (ICD) algorithm accurately identifies severe sleep apnea (SA). In the present analysis, we tested the hypothesis that RDI could also predict atrial fibrillation (AF) burden. Methods: Patients with ejection fraction ≤35% implanted with an ICD were enrolled and followed up for 24 months. One month after implantation, patients underwent a polysomnographic study. The weekly mean RDI value was considered, as calculated during the entire follow-up period and over a 1-week period preceding the sleep study. The endpoints were as follows: daily AF burden of ≥5 min, ≥6 h, ≥23 h. Results: Here, 164 patients had usable RDI values during the entire follow-up period. Severe SA (RDI ≥ 30 episodes/h) was diagnosed in 92 (56%) patients at the time of the sleep study. During follow-up, AF burden ≥ 5 min/day was documented in 70 (43%), ≥6 h/day in 48 (29%), and ≥23 h/day in 33 (20%) patients. Device-detected RDI ≥ 30 episodes/h at the time of the polygraphy, as well as the polygraphy-measured apnea hypopnea index ≥ 30 episodes/h, were not associated with the occurrence of the endpoints, using a Cox regression model. However, using a time-dependent model, continuously measured weekly mean RDI ≥ 30 episodes/h was independently associated with AF burden ≥ 5 min/day (hazard ratio [HR]: 2.13, 95% confidence interval [CI]: 1.24–3.65, p =.006), ≥6 h/day (HR: 2.75, 95% CI: 1.37–5.49, p =.004), and ≥23 h/day (HR: 2.26, 95% CI: 1.05–4.86, p =.037). Conclusions: In heart failure patients, ICD-diagnosed severe SA on follow-up data review identifies patients who are from two- to three-fold more likely to experience an AF episode, according to various thresholds of daily AF burden.

2022 - Atrial Fibrillation and Dementia: A Report From the AF-SCREEN International Collaboration [Articolo su rivista]
Rivard, L.; Friberg, L.; Conen, D.; Healey, J. S.; Berge, T.; Boriani, G.; Brandes, A.; Calkins, H.; Camm, A. J.; Yee Chen, L.; Lluis Clua Espuny, J.; Collins, R.; Connolly, S.; Dagres, N.; Elkind, M. S. V.; Engdahl, J.; Field, T. S.; Gersh, B. J.; Glotzer, T. V.; Hankey, G. J.; Harbison, J. A.; Georg Haeusler, K.; Hills, M. T.; Johnson, L. S. B.; Joung, B.; Khairy, P.; Kirchhof, P.; Krieger, D.; Lip, G. Y. H.; Lochen, M. -L.; Madhavan, M.; Mairesse, G. H.; Montaner, J.; Ntaios, G.; Quinn, T. J.; Rienstra, M.; Rosenqvist, M.; Sandhu, R. K.; Smyth, B.; Schnabel, R. B.; Stavrakis, S.; Themistoclakis, S.; Van Gelder, I. C.; Wang, J. -G.; Freedman, B.
abstract

Growing evidence suggests a consistent association between atrial fibrillation (AF) and cognitive impairment and dementia that is independent of clinical stroke. This report from the AF-SCREEN International Collaboration summarizes the evidence linking AF to cognitive impairment and dementia. It provides guidance on the investigation and management of dementia in patients with AF on the basis of best available evidence. The document also addresses suspected pathophysiologic mechanisms and identifies knowledge gaps for future research. Whereas AF and dementia share numerous risk factors, the association appears to be independent of these variables. Nevertheless, the evidence remains inconclusive regarding a direct causal effect. Several pathophysiologic mechanisms have been proposed, some of which are potentially amenable to early intervention, including cerebral microinfarction, AF-related cerebral hypoperfusion, inflammation, microhemorrhage, brain atrophy, and systemic atherosclerotic vascular disease. The mitigating role of oral anticoagulation in specific subgroups (eg, low stroke risk, short duration or silent AF, after successful AF ablation, or atrial cardiopathy) and the effect of rhythm versus rate control strategies remain unknown. Likewise, screening for AF (in cognitively normal or cognitively impaired patients) and screening for cognitive impairment in patients with AF are debated. The pathophysiology of dementia and therapeutic strategies to reduce cognitive impairment warrant further investigation in individuals with AF. Cognition should be evaluated in future AF studies and integrated with patient-specific outcome priorities and patient preferences. Further large-scale prospective studies and randomized trials are needed to establish whether AF is a risk factor for cognitive impairment, to investigate strategies to prevent dementia, and to determine whether screening for unknown AF followed by targeted therapy might prevent or reduce cognitive impairment and dementia.

2022 - Atrial Fibrillation and the Risk of Early‐Onset Dementia: A Systematic Review and Meta‐Analysis [Articolo su rivista]
Giannone, Maria Edvige; Filippini, Tommaso; Whelton, Paul K.; Chiari, Annalisa; Vitolo, Marco; Boriani, Giuseppe; Vinceti, Marco
abstract

BACKGROUNDRecent studies have identified an increased risk of dementia in patients with atrial fibrillation (AF). However, both AF and dementia usually manifest late in life. Few studies have investigated this association in adults with early‐onset dementia. The aim of this study was to investigate the relationship between AF and early‐onset dementia. METHODS AND RESULTSWe searched the PubMed/MEDLINE, Embase, and Scopus databases through April 15, 2022, for studies reporting on the association between AF and dementia in adults aged <70 years, without language restrictions. Two reviewers independently performed the study selection, assessed the risk of bias, and extracted the study data. We performed a meta‐analysis of early‐onset dementia risk according to occurrence of AF using a random‐effects model. We retrieved and screened 1006 potentially eligible studies. We examined the full text of 33 studies and selected the 6 studies that met our inclusion criteria. The pooled analysis of their results showed an increased risk of developing dementia in individuals with AF, with a summary relative risk of 1.50 (95% CI, 1.00–2.26) in patients aged <70 years, and 1.06 (95% CI, 0.55–2.06) in those aged <65 years. CONCLUSIONSIn this systematic review and meta‐analysis, AF was a risk factor for dementia in adults aged <70 years, with an indication of a slight and statistically imprecise excess risk already at ages <65 years. Further research is needed to assess which characteristics of the arrhythmia and which mechanisms play a role in this relationship.

2022 - Atrial Fibrillation in the Setting of Acute Pneumonia: Not a Secondary Arrhythmia [Articolo su rivista]
Maisano, A.; Vitolo, M.; Imberti, J. F.; Bonini, N.; Albini, A.; Valenti, A. C.; Sgreccia, D.; Mantovani, M.; Malavasi, V. L.; Boriani, G.
abstract

Atrial fibrillation (AF) is the most common arrhythmia in the setting of critically ill patients. Pneumonia, and in particular communityacquired pneumonia, is one of the most common causes of illness and hospital admission worldwide. This article aims to review the association between AF and acute diseases, with specific attention to pneumonia, from the pathophysiology to its clinical significance. Even though the relationship between pneumonia and AF has been known for years, it was once considered a transient bystander. In recent years there has been growing knowledge on the clinical significance of this arrhythmia in acute clinical settings, in which it holds a prognostic role which is not so different as compared to that of the so-called "primary"AF. AF is a distinct entity even in the setting of pneumonia, and acute critical illnesses in general, and it should therefore be managed with a guidelines-oriented approach, including prescription of anticoagulants in patients at thromboembolic risk, always considering patients' individuality. More data on the significance of the arrhythmia in this setting will help clinicians to give patients the best possible care.

2022 - Atrial High-Rate Episodes Detected by Cardiac Implantable Electronic Devices: Dynamic Changes in Episodes and Predictors of Incident Atrial Fibrillation [Articolo su rivista]
Imberti, J. F.; Bonini, N.; Tosetti, A.; Mei, D. A.; Gerra, L.; Malavasi, V. L.; Mazza, A.; Lip, G. Y. H.; Boriani, G.
abstract

Background. Atrial high rate episodes (AHRE) detected by cardiac implantable electronic devices (CIEDs) may be associated with a risk of progression towards long-lasting episodes (≥24 h) and clinical atrial fibrillation (AF). Methods. Consecutive CIED patients presenting AHRE (with confirmation of an arrhythmia lasting 5 min–23 h 59 min, atrial rate ≥175/min, with no AF at 12-lead ECG and no prior clinical AF) were retrospectively enrolled. The aims of this study were to describe patients’ characteristics and the incidence of adverse events, and second, to identify potential predictors of the composite outcome of clinical AF and/or AHRE episodes lasting ≥24 h. Results. 104/107 (97.2%) patients (median age 79.7 (74.0–84.2), 33.7% female) had available follow-up data. Over a median follow-up of 24.3 (10.6–40.3) months, 31/104 (29.8%) patients experienced the composite outcome of clinical AF or AHRE episodes lasting ≥24 h. Baseline CHA2DS2-VASc score and the longest AHRE episode at enrollment lasting 12 h–23 h 59 min were independently associated with the composite outcome (Hazard ratio (HR); 95% CI: 1.40; 1.07–1.83 and HR: 8.15; 95% CI 2.32–28.65, respectively). Baseline CHA2DS2-VASc score and the longest AHRE episode at enrollment lasting 12 h–23 h 59 min were the only independent predictors of incident clinical AF (HR: 1.45; 95% CI 1.06–2.00 and HR: 4.25; 95% CI 1.05–17.20, respectively). Conclusions. In patients with AHRE, the incidence of clinical AF or AHRE episodes lasting ≥24 h is high in a two-year follow-up. Baseline patients’ characteristics (CHA2DS2-VASc score) and AHRE duration may help to intensify monitoring and decision-making, being independently associated with clinical AF at follow-up.

2022 - Atrial cardiomyopathy: a derangement in atrial volumes, geometry, function, and pathology with important clinical implications [Articolo su rivista]
Boriani, G.; Vitolo, M.; Imberti, J. F.
abstract

2022 - Atrial fibrillation ablation in heart failure: Findings from the ESC-EHRA EORP Atrial Fibrillation Ablation long-term (AFA LT) registry [Articolo su rivista]
Temporelli, P. L.; Arbelo, E.; Laroche, C.; Blomstrom-Lundqvist, C.; Kirchhof, P.; Lip, G. Y. H.; Boriani, G.; Nakou, E.; Maggioni, A. P.; Tavazzi, L.
abstract

Background: The current practice of atrial fibrillation ablation (AFA) as a treatment option for atrial fibrillation (AF) in patients with heart failure (HF) across Europe, their clinical profiles and outcomes is still undefined. Methods: The European Society of Cardiology (ESC) led a prospective observational registry of consecutive patients undergoing AFA, in 27 member countries. The subgroup of patients with HF, followed-up for 1 year, was analyzed and the results are reported. Results: Of the 3582 AF patients in the Registry, 537 (14.9%) had HF. Diabetes, hypertension, hypercholesterolemia, CHA2DS2-VASc score ≥ 2, structural heart disease and persistent AF were more common in HF than non-HF patients (all p < 0.001). However the in-hospital complications were less frequent in HF patients (5.0% vs. 8.2% p = 0.01). Both in-hospital and 1-year outcomes, including 1-year AF recurrence (15.4%) and repeat ablations (9.5%), were similar in both groups. We subdivided HF patients according to their left ventricular ejection fraction (EF) at baseline into reduced (HFrEF, <40%), mid-range (HFmEF, 40–49%), or preserved EF (HFpEF, ≥ 50%). Most patients were HFpEF (n 375, 77%), 72 (15%) were HFmEF and 8% HFrEF. The most frequent underlying conditions in HFpEF were hypertension and ischemic heart disease, while those most common in HFmEF and HFrEF were valvular and dilated cardiomyopathy. Conclusion: In routine care in Europe, HF patients represent a minority of patients undergoing AFA, and most belong to the HFpEF phenotype. The limited clinical research on AFA HFpEF patients is reflected by the uncertainty expressed in the current AF Guidelines and Expert statements.

2022 - Atrial fibrillation post-coronary or cardiac surgery: A transient inflammation-related event or the expression of a pre-existing arrhythmogenic atrial substrate? [Articolo su rivista]
Boriani, Giuseppe; Vitolo, Marco; Imberti, Jacopo F
abstract

2022 - Atrial high rate episodes as a marker of atrial cardiomyopathy: In the quest of the Holy Grail. Author's reply [Articolo su rivista]
Vitolo, M.; Imberti, J. F.; Proietti, M.; Lip, G. Y. H.; Boriani, G.
abstract

2022 - Burden of disease and costs of infections associated with cardiac implantable electronic devices [Articolo su rivista]
Sgreccia, D.; Vitolo, M.; Valenti, A. C.; Manicardi, M.; Boriani, G.
abstract

Introduction: Infections are complications of Cardiac Implantable Electronic Device (CIED) procedures, associated with high mortality (20–25% at 1 year), long hospitalizations (23–30 days), and high costs for health-care systems (often higher than 30.000 €). The incidence rates are around 1–4%. Prevention strategies appear to be the best approach for minimizing the occurrence of CIED infections, but in real-world, the recommendations for the best practices are not always followed. Among the recommended preventive measures, the antibacterial envelope has proven to be effective in reducing CIED-related infections. Areas covered: Published studies investigate the role of antibacterial envelopes in infection prevention and the use of infection risk scores to select high-risk patients undergoing CIED implantation/replacement who can benefit from additional preventive measures. Expert opinion: A proficient selection of the best candidates for the antibacterial envelope can be the basis for reducing the healthcare system’s costs, in line with the principles of cost-effectiveness. Risk scores have been developed to select patients at high risk of CIED infections and their use appears simple and more complete than individual factors alone. Among them, the PADIT score seems to be effective in selecting patients eligible for antibacterial envelope insertion, with a good cost-effectiveness profile.

2022 - Cardiac troponins and adverse outcomes in European patients with atrial fibrillation: A report from the ESC-EHRA EORP atrial fibrillation general long-term registry [Articolo su rivista]
Vitolo, M.; Malavasi, V. L.; Proietti, M.; Diemberger, I.; Fauchier, L.; Marin, F.; Nabauer, M.; Potpara, T. S.; Dan, G. -A.; Kalarus, Z.; Tavazzi, L.; Maggioni, A. P.; Lane, D. A.; Lip, G. Y. H.; Boriani, G.
abstract

Background: Cardiac troponins (cTn) have been reported to be predictors for adverse outcomes in atrial fibrillation (AF), patients, but their actual use is still unclear. Aim: To assess the factors associated with cTn testing in routine practice and evaluate the association with outcomes. Methods: Patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry were stratified into 3 groups according to cTn levels as (i) cTn not tested, (ii) cTn in range (≤99th percentile), (iii) cTn elevated (>99th percentile). The composite outcome of any thromboembolism /any acute coronary syndrome/cardiovascular (CV) death, defined as Major Adverse Cardiovascular Events (MACE) and all-cause death were the main endpoints. Results: Among 10 445 AF patients (median age 71 years, 40.3% females) cTn were tested in 2834 (27.1%). cTn was elevated in 904/2834 (31.9%) and in-range in 1930/2834 (68.1%) patients. Female sex, in-hospital enrollment, first-detected AF, CV risk factors, history of coronary artery disease, and atypical AF symptoms were independently associated with cTn testing. Elevated cTn were independently associated with a higher risk for MACE (Model 1, hazard ratio [HR] 1.74, 95% confidence interval [CI] 1.40–2.16, Model 2, HR 1.62, 95% CI 1.28–2.05; Model 3 HR 1.76, 95% CI 1.37–2.26) and all-cause death (Model 1, HR 1.45, 95% CI 1.21–1.74; Model 2, HR 1.36, 95% CI 1.12–1.66; Model 3, HR 1.38, 95% CI 1.12–1.71). Conclusions: Elevated cTn levels were associated with an increased risk of all-cause mortality and adverse CV events. Clinical factors that might enhance the need to rule out CAD were associated with cTn testing.

2022 - Case Report: Free-Floating Intracoronary Thrombus: Who Is the Convict? [Articolo su rivista]
Mantovani, F.; Paolini, A.; Barbieri, A.; Boriani, G.
abstract

In young patients, especially with no traditional coronary risk factors, hypercoagulable states may always be considered as an alternative cause of acute coronary syndromes. The concomitant thrombotic and bleeding risk associated with myeloproliferative disorders complicates the decision-making, particularly regarding long-term dual antiplatelet therapy. The chosen therapy may need to be frequently revisited, depending on the patient’s bleeding complications. We reported the case of a 49-year-old woman with acute myocardial infarction with no traditional risk factors for coronary artery disease where a myeloproliferative neoplasm was diagnosed.

2022 - Chronic Kidney Disease with Mild and Mild to Moderate Reduction in Renal Function and Long-Term Recurrences of Atrial Fibrillation after Pulmonary Vein Cryoballoon Ablation [Articolo su rivista]
Boriani, G.; Iacopino, S.; Arena, G.; Pieragnoli, P.; Verlato, R.; Manfrin, M.; Molon, G.; Rovaris, G.; Curnis, A.; Perego, G. B.; Dello Russo, A.; Landolina, M.; Vitolo, M.; Tondo, C.
abstract

The aim of this research was to evaluate if patients with chronic kidney disease (CKD) and mild or mild to moderate depression of renal function have an increased risk of atrial fibrillation (AF) recurrences after cryoballoon (CB) ablation. We performed a retrospective analysis of AF patients undergoing pulmonary vein isolation (PVI) by CB. The cohort was divided according to the KDIGO CKD-EPI classification into a (1) normal, (2) mildly decreased, or (3) mild to moderate reduction in estimated glomerular filtration rate (eGFR). Freedom from AF recurrences was the primary endpoint. A total of 1971 patients were included (60 ± 10 years, 29.0% females, 73.6% paroxysmal AF) in the study. Acute success and complication rates were 99.2% and 3.7%, respectively, with no significant differences among the three groups. After a follow-up of 24 months, AF recurrences were higher in the mildly and mild to moderate CKD groups compared to the normal kidney function group (23.4% vs. 28.3% vs. 33.5%, p < 0.05). Mild to moderate CKD was an independent predictor of AF recurrences after the blanking period (hazard ratio:1.38, 95% CI 1.02–1.86, p = 0.037). In conclusion, a multicenter analysis of AF patients treated with cryoablation revealed mild to moderate reductions in renal functions were associated with a higher risk of AF recurrences. Conversely, the procedural success and complication rates were similar in patients with normal, mildly reduced, or mild to moderate reduction in eGFR.

2022 - Clinical Complexity Domains, Anticoagulation, and Outcomes in Patients with Atrial Fibrillation: A Report from the GLORIA-AF Registry Phase II and III [Articolo su rivista]
Romiti, G. F.; Proietti, M.; Bonini, N.; Ding, W. Y.; Boriani, G.; Huisman, M. V.; Lip, G. Y. H.
abstract

Background Clinical complexity is common in atrial fibrillation (AF) patients. We assessed the impact of clinical complexity on oral anticoagulant (OAC) treatment patterns and major adverse outcomes in a contemporary cohort of AF patients. Methods The GLORIA-AF Phase II and III Registry enrolled newly diagnosed AF patients with at least one stroke risk factor. Among patients with CHA2DS2-VASc score ≥2, we defined four domains of perceived clinical complexity: frail elderly (age ≥75 years and body mass index 23 kg/m2), chronic kidney disease (CKD, creatinine clearance 60 mL/min), history of bleeding, and those with ≥2 of the above conditions. We evaluated the associations between clinical complexity domains and antithrombotic treatment prescription, risk of OAC discontinuation, and major adverse outcomes. Results Among the 29,625 patients included (mean age 69.6 ± 10.7 years, 44.2% females), 9,504 (32.1%) presented with at least one complexity criterion. Clinical complexity was associated with lower OAC prescription, with stronger associations in frail elderly (odds ratio [OR]: 0.47, 95% confidence interval [CI]: 0.36-0.62) and those with ≥2 complexity domains (OR: 0.50, 95% CI: 0.44-0.57). Risk of OAC discontinuation was higher among frail elderly (hazard ratio [HR]: 1.30, 95% CI: 1.00-1.69), CKD (HR: 1.10, 95% CI: 1.02-1.20), and those with ≥ 2 complexity domains (HR: 1.39, 95% CI: 1.23-1.57). Clinical complexity was associated with higher risk of the primary outcome of all-cause death, thromboembolism, and major bleeding, with the highest magnitude in those with ≥ 2 criteria (HR: 1.63, 95% CI: 1.43-1.86). Conclusion In AF patients, clinical complexity influences OAC treatment management, and increases the risk of poor clinical outcomes. These patients require additional efforts, such as integrated care approach, to improve their management and prognosis.

2022 - Clinical Profile, Arrhythmias, and Adverse Cardiac Outcomes in Emery–Dreifuss Muscular Dystrophies: A Systematic Review of the Literature [Articolo su rivista]
Valenti, A. C.; Albini, A.; Imberti, J. F.; Vitolo, M.; Bonini, N.; Lattanzi, G.; Schnabel, R. B.; Boriani, G.
abstract

Cardiolaminopathies are a heterogeneous group of disorders which are due to mutations in the genes encoding for nuclear lamins or their binding proteins. The whole spectrum of cardiac manifestations encompasses atrial arrhythmias, conduction disturbances, progressive systolic dysfunction, and malignant ventricular arrhythmias. Despite the prognostic significance of cardiac involvement in this setting, the current recommendations lack strong evidence. The aim of our work was to systematically review the current data on the main cardiovascular outcomes in cardiolaminopathies. We searched PubMed/Embase for studies focusing on cardiovascular outcomes in LMNA mutation carriers (atrial arrhythmias, ventricular arrhythmias, sudden cardiac death, conduction disturbances, thromboembolic events, systolic dysfunction, heart transplantation, and all-cause and cardiovascular mortality). In total, 11 studies were included (1070 patients, mean age between 26–45 years, with follow-up periods ranging from 2.5 years up to 45 ± 12). When available, data on the EMD-mutated population were separately reported (40 patients). The incidence rates (IR) were individually assessed for the outcomes of interest. The IR for atrial fibrillation/atrial flutter/atrial tachycardia ranged between 6.1 and 13.9 events/100 pts–year. The IR of atrial standstill ranged between 0 and 2 events/100 pts-year. The IR for malignant ventricular arrhythmias reached 10.2 events/100 pts–year and 15.6 events/100 pts–year for appropriate implantable cardioverter–defibrillator (ICD) interventions. The IR for advanced conduction disturbances ranged between 3.2 and 7.7 events/100 pts–year. The IR of thromboembolic events reached up to 8.9 events/100 pts–year. Our results strengthen the need for periodic cardiological evaluation focusing on the early recognition of atrial arrhythmias, and possibly for the choice of preventive strategies for thromboembolic events. The frequent need for cardiac pacing due to advanced conduction disturbances should be counterbalanced with the high risk of malignant ventricular arrhythmias that would justify ICD over pacemaker implantation.

2022 - Clinical complexity and impact of the ABC (Atrial fibrillation Better Care) pathway in patients with atrial fibrillation: a report from the ESC-EHRA EURObservational Research Programme in AF General Long-Term Registry [Articolo su rivista]
Romiti, G. F.; Proietti, M.; Vitolo, M.; Bonini, N.; Fawzy, A. M.; Ding, W. Y.; Fauchier, L.; Marin, F.; Nabauer, M.; Dan, G. A.; Potpara, T. S.; Boriani, G.; Lip, G. Y. H.
abstract

BACKGROUND: Clinical complexity is increasingly prevalent among patients with atrial fibrillation (AF). The 'Atrial fibrillation Better Care' (ABC) pathway approach has been proposed to streamline a more holistic and integrated approach to AF care; however, there are limited data on its usefulness among clinically complex patients. We aim to determine the impact of ABC pathway in a contemporary cohort of clinically complex AF patients. METHODS: From the ESC-EHRA EORP-AF General Long-Term Registry, we analysed clinically complex AF patients, defined as the presence of frailty, multimorbidity and/or polypharmacy. A K-medoids cluster analysis was performed to identify different groups of clinical complexity. The impact of an ABC-adherent approach on major outcomes was analysed through Cox-regression analyses and delay of event (DoE) analyses. RESULTS: Among 9966 AF patients included, 8289 (83.1%) were clinically complex. Adherence to the ABC pathway in the clinically complex group reduced the risk of all-cause death (adjusted HR [aHR]: 0.72, 95%CI 0.58-0.91), major adverse cardiovascular events (MACEs; aHR: 0.68, 95%CI 0.52-0.87) and composite outcome (aHR: 0.70, 95%CI: 0.58-0.85). Adherence to the ABC pathway was associated with a significant reduction in the risk of death (aHR: 0.74, 95%CI 0.56-0.98) and composite outcome (aHR: 0.76, 95%CI 0.60-0.96) also in the high-complexity cluster; similar trends were observed for MACEs. In DoE analyses, an ABC-adherent approach resulted in significant gains in event-free survival for all the outcomes investigated in clinically complex patients. Based on absolute risk reduction at 1 year of follow-up, the number needed to treat for ABC pathway adherence was 24 for all-cause death, 31 for MACEs and 20 for the composite outcome. CONCLUSIONS: An ABC-adherent approach reduces the risk of major outcomes in clinically complex AF patients. Ensuring adherence to the ABC pathway is essential to improve clinical outcomes among clinically complex AF patients.

2022 - Clinical implications of assessing frailty in elderly patients treated with permanent cardiac pacing [Articolo su rivista]
Boriani, G.; Valenti, A. C.; Vitolo, M.
abstract

2022 - Clinical utility and prognostic implications of the novel 4S-AF scheme to characterize and evaluate patients with atrial fibrillation: a report from ESC-EHRA EORP-AF Long-Term General Registry [Articolo su rivista]
Ding, W. Y.; Proietti, M.; Boriani, G.; Fauchier, L.; Blomstrom-Lundqvist, C.; Marin, F.; Potpara, T. S.; Lip, G. Y. H.
abstract

AIMS: The 4S-AF classification scheme comprises of four domains: stroke risk (St), symptoms (Sy), severity of atrial fibrillation (AF) burden (Sb), and substrate (Su). We sought to examine the implementation of the 4S-AF scheme in the EORP-AF General Long-Term Registry and compare outcomes in AF patients according to the 4S-AF-led decision-making process. METHODS AND RESULTS : Atrial fibrillation patients from 250 centres across 27 European countries were included. A 4S-AF score was calculated as the sum of each domain with a maximum score of 9. Of 6321 patients, 8.4% had low (St), 47.5% EHRA I (Sy), 40.5% newly diagnosed or paroxysmal AF (Sb), and 5.1% no cardiovascular risk factors or left atrial enlargement (Su). Median follow-up was 24 months. Using multivariable Cox regression analysis, independent predictors of all-cause mortality were (St) [adjusted hazard ratio (aHR) 8.21, 95% confidence interval (CI): 2.60-25.9], (Sb) (aHR 1.21, 95% CI: 1.08-1.35), and (Su) (aHR 1.27, 95% CI: 1.14-1.41). For CV mortality and any thromboembolic event, only (Su) (aHR 1.73, 95% CI: 1.45-2.06) and (Sy) (aHR 1.29, 95% CI: 1.00-1.66) were statistically significant, respectively. None of the domains were independently linked to ischaemic stroke or major bleeding. Higher 4S-AF score was related to a significant increase in all-cause mortality, CV mortality, any thromboembolic event, and ischaemic stroke but not major bleeding. Treatment of all 4S-AF domains was associated with an independent decrease in all-cause mortality (aHR 0.71, 95% CI: 0.55-0.92). For each 4S-AF domain left untreated, the risk of all-cause mortality increased substantially (aHR 1.35, 95% CI: 1.16-1.56). CONCLUSION : Implementation of the novel 4S-AF scheme is feasible, and treatment decisions based on this scheme improve mortality rates in AF.

2022 - Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry [Articolo su rivista]
Lip, G. Y. H.; Kotalczyk, A.; Teutsch, C.; Diener, H. -C.; Dubner, S. J.; Halperin, J. L.; Ma, C. -S.; Rothman, K. J.; Marler, S.; Gurusamy, V. K.; Huisman, M. V.; Abban, D. W.; Aziz, E.; Kalan, M. B.; Abdul, N.; Backes, L. M.; Bradman, D.; Abud, A. M.; Badings, E.; Brautigam, D.; Adams, F.; Bagni, E.; Breton, N.; Addala, S.; Baker, S. H.; Brouwers, P. J. A. M.; Adragao, P.; Bala, R.; Browne, K.; Ageno, W.; Baldi, A.; Cortada, J. B.; Aggarwal, R.; Bando, S.; Bruni, A.; Agosti, S.; Banerjee, S.; Brunschwig, C.; Agostoni, P.; Bank, A.; Buathier, H.; Aguilar, F.; Esquivias, G. B.; Buhl, A.; Linares, J. A.; Barr, C.; Bullinga, J.; Aguinaga, L.; Bartlett, M.; Cabrera, J. W.; Ahmed, J.; Basic Kes, V.; Caccavo, A.; Aiello, A.; Baula, G.; Cai, S.; Ainsworth, P.; Behrens, S.; Caine, S.; Aiub, J. R.; Bell, A.; Calo, L.; Al-Dallow, R.; Benedetti, R.; Calvi, V.; Alderson, L.; Mazuecos, J. B.; Sanchez, M. C.; Velasco, J. A. A.; Benhalima, B.; Candeias, R.; Alexopoulos, D.; Bergler-Klein, J.; Capuano, V.; Manterola, F. A.; Berneau, J. -B.; Capucci, A.; Aliyar, P.; Bernstein, R. A.; Caputo, R.; Alonso, D.; Berrospi, P.; Rizo, T. C.; da Costa, F. A. A.; Berti, S.; Cardona, F.; Amado, J.; Berz, A.; da Costa Darrieux, F. C.; Amara, W.; Best, E.; Vera, Y. C. D.; Amelot, M.; Bettencourt, P.; Carolei, A.; Amjadi, N.; Betzu, R.; Carreno, S.; Ammirati, F.; Bhagwat, R.; Carvalho, P.; Andrade, M.; Bhatta, L.; Cary, S.; Andrawis, N.; Biscione, F.; Casu, G.; Annoni, G.; Bisignani, G.; Cavallini, C.; Ansalone, G.; Black, T.; Cayla, G.; Ariani, M. K.; Bloch, M. J.; Celentano, A.; Arias, J. C.; Bloom, S.; Cha, T. -J.; Armero, S.; Blumberg, E.; Cha, K. S.; Arora, C.; Bo, M.; Chae, J. K.; Aslam, M. S.; Bohmer, E.; Chalamidas, K.; Asselman, M.; Bollmann, A.; Challappa, K.; Audouin, P.; Bongiorni, M. G.; Chand, S. P.; Augenbraun, C.; Boriani, G.; Chandrashekar, H.; Aydin, S.; Boswijk, D. J.; Chartier, L.; Aydin, S.; Bott, J.; Chatterjee, K.; Ayryanova, I.; Bottacchi, E.; Ayala, C. A. C.; Cheema, A.; Davis, G.; Evonich, R.; Cheema, A.; Davy, J. -M.; Evseeva, O.; Chen, L.; Dayer, M.; Ezhov, A.; Chen, S. -A.; De Biasio, M.; Fahmy, R.; Chen, J. H.; De Bonis, S.; Fang, Q.; Chiang, F. -T.; De Caterina, R.; Farsad, R.; Chiarella, F.; De Franceschi, T.; Fauchier, L.; Chih-Chan, L.; de Groot, J. R.; Favale, S.; Cho, Y. K.; De Horta, J.; Fayard, M.; Choi, J. -I.; De La Briolle, A.; Fedele, J. L.; Choi, D. J.; de la Pena Topete, G.; Fedele, F.; Chouinard, G.; de Paola, A. A. V.; Fedorishina, O.; Chow, D. H. -F.; de Souza, W.; Fera, S. R.; Chrysos, D.; de Veer, A.; Ferreira, L. G. G.; Chumakova, G.; De Wolf, L.; Ferreira, J.; Valenzuela, E. J. J. R. C.; Decoulx, E.; Ferri, C.; Nica, N. C.; Deepak, S.; Ferrier, A.; Cislowski, D. J.; Defaye, P.; Ferro, H.; Clay, A.; Munoz, F. D. -C.; Finsen, A.; Clifford, P.; Brkljacic, D. D.; First, B.; Cohen, A.; Deumite, N. J.; Fischer, S.; Cohen, M.; Di Legge, S.; Fonseca, C.; Cohen, S.; Diemberger, I.; Almeida, L. F.; Colivicchi, F.; Dietz, D.; Forman, S.; Collins, R.; Dionisio, P.; Frandsen, B.; Colonna, P.; Dong, Q.; French, W.; Compton, S.; dos Santos, F. R.; Friedman, K.; Connolly, D.; Dotcheva, E.; Friese, A.; Conti, A.; Doukky, R.; Fruntelata, A. G.; Buenostro, G. C.; D'Souza, A.; Fujii, S.; Coodley, G.; Dubrey, S.; Fumagalli, S.; Cooper, M.; Ducrocq, X.; Fundamenski, M.; Coronel, J.; Dupljakov, D.; Furukawa, Y.; Corso, G.; Duque, M.; Gabelmann, M.; Sales, J. C.; Dutta, D.; Gabra, N.; Cottin, Y.; Duvilla, N.; Gadsboll, N.; Covalesky, J.; Duygun, A.; Galinier, M.; Cracan, A.; Dziewas, R.; Gammelgaard, A.; Crea, F.; Eaton, C. B.; Ganeshkumar, P.; Crean, P.; Eaves, W.; Gans, C.; Crenshaw, J.; Ebels-Tuinbeek, L. A.; Quintana, A. G.; Cullen, T.; Ehrlich, C.; Gartenlaub, O.; Darius, H.; Eichinger-Hasenauer, S.; Gaspardone, A.; Dary, P.; Eisenberg, S. J.; Genz, C.; Dascotte, O.; Jabali, A. E.; Georger, F.; Dauber, I.; Shahawy, M. E.; Georges, J. -L.; Davalos, V.; Hernandes, M. E.; Georgeson, S.; Davies, R.; Izal, A. E.; Giedrimas, E.; G
abstract

Background and purpose: Prospectively collected data comparing the safety and effectiveness of individual non-vitamin K antagonists (NOACs) are lacking. Our objective was to directly compare the effectiveness and safety of NOACs in patients with newly diagnosed atrial fibrillation (AF). Methods: In GLORIA-AF, a large, prospective, global registry program, consecutive patients with newly diagnosed AF were followed for 3 years. The comparative analyses for (1) dabigatran vs rivaroxaban or apixaban and (2) rivaroxaban vs apixaban were performed on propensity score (PS)-matched patient sets. Proportional hazards regression was used to estimate hazard ratios (HRs) for outcomes of interest. Results: The GLORIA-AF Phase III registry enrolled 21,300 patients between January 2014 and December 2016. Of these, 3839 were prescribed dabigatran, 4015 rivaroxaban and 4505 apixaban, with median ages of 71.0, 71.0, and 73.0 years, respectively. In the PS-matched set, the adjusted HRs and 95% confidence intervals (CIs) for dabigatran vs rivaroxaban were, for stroke: 1.27 (0.79–2.03), major bleeding 0.59 (0.40–0.88), myocardial infarction 0.68 (0.40–1.16), and all-cause death 0.86 (0.67–1.10). For the comparison of dabigatran vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 1.16 (0.76–1.78), myocardial infarction 0.84 (0.48–1.46), major bleeding 0.98 (0.63–1.52) and all-cause death 1.01 (0.79–1.29). For the comparison of rivaroxaban vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 0.78 (0.52–1.19), myocardial infarction 0.96 (0.63–1.45), major bleeding 1.54 (1.14–2.08), and all-cause death 0.97 (0.80–1.19). Conclusions: Patients treated with dabigatran had a 41% lower risk of major bleeding compared with rivaroxaban, but similar risks of stroke, MI, and death. Relative to apixaban, patients treated with dabigatran had similar risks of stroke, major bleeding, MI, and death. Rivaroxaban relative to apixaban had increased risk for major bleeding, but similar risks for stroke, MI, and death. Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01468701, NCT01671007. Date of registration: September 2013. Graphical abstract: [Figure not available: see fulltext.]

2022 - Comparing atrial fibrillation guidelines: Focus on stroke prevention, bleeding risk assessment and oral anticoagulant recommendations [Articolo su rivista]
Imberti, J. F.; Mei, D. A.; Vitolo, M.; Bonini, N.; Proietti, M.; Potpara, T.; Lip, G. Y. H.; Boriani, G.
abstract

Clinical practice in atrial fibrillation (AF) patient management is constantly evolving. In the past 3 years, various new AF guidelines or focused updates have been published, given this rapidly evolving field. In 2019, the American College of Cardiology/American Heart Association published a focused update of the 2014 guidelines. In 2020, both the European Society of Cardiology and the Canadian Cardiovascular Society released their new guidelines. Finally, the most recent guidelines were those published in 2021 by the Asian Pacific Heart Rhythm Society, which updates their 2017 version and the 2021 National Institute for Health and Care Excellence (NICE) guidelines. In the present narrative review, we compare these guidelines, emphasizing similarities and differences in the following mainstay elements of patient care: thromboembolic risk assessment, oral anticoagulants (OACs) prescription, bleeding risk evaluation, and integrated patient management. A formal evaluation of baseline thromboembolic and bleeding risks and their reassessment during follow-up is evenly recommended, although some differences in using risk stratification scores. OACs prescription is highly encouraged where appropriate, and prescription algorithms are broadly similar. The importance of an integrated and multidisciplinary approach to patient care is emerging, aiming to address several different aspects of a multifaceted disease.

2022 - Consumer-Led Screening for Atrial Fibrillation: Frontier Review of the AF-SCREEN International Collaboration [Articolo su rivista]
Brandes, Axel; Stavrakis, Stavros; Freedman, Ben; Antoniou, Sotiris; Boriani, Giuseppe; Camm, A John; Chow, Clara K; Ding, Eric; Engdahl, Johan; Gibson, Michael M; Golovchiner, Gregory; Glotzer, Taya; Guo, Yutao; Healey, Jeff S; Hills, Mellanie T; Johnson, Linda; Lip, Gregory Y H; Lobban, Trudie; Macfarlane, Peter W; Marcus, Gregory M; Mcmanus, David D; Neubeck, Lis; Orchard, Jessica; Perez, Marco V; Schnabel, Renate B; Smyth, Breda; Steinhubl, Steven; Turakhia, Mintu P
abstract

The technological evolution and widespread availability of wearables and handheld ECG devices capable of screening for atrial fibrillation (AF), and their promotion directly to consumers, has focused attention of health care professionals and patient organizations on consumer-led AF screening. In this Frontiers review, members of the AF-SCREEN International Collaboration provide a critical appraisal of this rapidly evolving field to increase awareness of the complexities and uncertainties surrounding consumer-led AF screening. Although there are numerous commercially available devices directly marketed to consumers for AF monitoring and identification of unrecognized AF, health care professional-led randomized controlled studies using multiple ECG recordings or continuous ECG monitoring to detect AF have failed to demonstrate a significant reduction in stroke. Although it remains uncertain if consumer-led AF screening reduces stroke, it could increase early diagnosis of AF and facilitate an integrated approach, including appropriate anticoagulation, rate or rhythm management, and risk factor modification to reduce complications. Companies marketing AF screening devices should report the accuracy and performance of their products in high- and low-risk populations and avoid claims about clinical outcomes unless improvement is demonstrated in randomized clinical trials. Generally, the diagnostic yield of AF screening increases with the number, duration, and temporal dispersion of screening sessions, but the prognostic importance may be less than for AF detected by single-time point screening, which is largely permanent, persistent, or high-burden paroxysmal AF. Consumer-initiated ECG recordings suggesting possible AF always require confirmation by a health care professional experienced in ECG reading, whereas suspicion of AF on the basis of photoplethysmography must be confirmed with an ECG. Consumer-led AF screening is unlikely to be cost-effective for stroke prevention in the predominantly young, early adopters of this technology. Studies in older people at higher stroke risk are required to demonstrate both effectiveness and cost-effectiveness. The direct interaction between companies and consumers creates new regulatory gaps in relation to data privacy and the registration of consumer apps and devices. Although several barriers for optimal use of consumer-led screening exist, results of large, ongoing trials, powered to detect clinical outcomes, are required before health care professionals should support widespread adoption of consumer-led AF screening.

2022 - Correction to: Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry (Clinical Research in Cardiology, (2022), 111, 5, (560-573), 10.1007/s00392-022-01996-2) [Articolo su rivista]
Lip, G. Y. H.; Kotalczyk, A.; Teutsch, C.; Diener, H. -C.; Dubner, S. J.; Halperin, J. L.; Ma, C. -S.; Rothman, K. J.; Marler, S.; Gurusamy, V. K.; Huisman, M. V.; Abban, D. W.; Aziz, E.; Kalan, M. B.; Abdul, N.; Backes, L. M.; Bradman, D.; Abud, A. M.; Badings, E.; Brautigam, D.; Adams, F.; Bagni, E.; Breton, N.; Addala, S.; Baker, S. H.; Brouwers, P. J. A. M.; Adragao, P.; Bala, R.; Browne, K.; Ageno, W.; Baldi, A.; Cortada, J. B.; Aggarwal, R.; Bando, S.; Bruni, A.; Agosti, S.; Banerjee, S.; Brunschwig, C.; Agostoni, P.; Bank, A.; Buathier, H.; Aguilar, F.; Esquivias, G. B.; Buhl, A.; Linares, J. A.; Barr, C.; Bullinga, J.; Aguinaga, L.; Bartlett, M.; Cabrera, J. W.; Ahmed, J.; Basic Kes, V.; Caccavo, A.; Aiello, A.; Baula, G.; Cai, S.; Ainsworth, P.; Behrens, S.; Caine, S.; Aiub, J. R.; Bell, A.; Calo, L.; Al-Dallow, R.; Benedetti, R.; Calvi, V.; Alderson, L.; Mazuecos, J. B.; Sanchez, M. C.; Velasco, J. A. A.; Benhalima, B.; Candeias, R.; Alexopoulos, D.; Bergler-Klein, J.; Capuano, V.; Manterola, F. A.; Berneau, J. -B.; Capucci, A.; Aliyar, P.; Bernstein, R. A.; Caputo, R.; Alonso, D.; Berrospi, P.; Rizo, T. C.; da Costa, F. A. A.; Berti, S.; Cardona, F.; Amado, J.; Berz, A.; da Costa Darrieux, F. C.; Amara, W.; Best, E.; Vera, Y. C. D.; Amelot, M.; Bettencourt, P.; Carolei, A.; Amjadi, N.; Betzu, R.; Carreno, S.; Ammirati, F.; Bhagwat, R.; Carvalho, P.; Andrade, M.; Bhatta, L.; Cary, S.; Andrawis, N.; Biscione, F.; Casu, G.; Annoni, G.; Bisignani, G.; Cavallini, C.; Ansalone, G.; Black, T.; Cayla, G.; Ariani, M. K.; Bloch, M. J.; Celentano, A.; Arias, J. C.; Bloom, S.; Cha, T. -J.; Armero, S.; Blumberg, E.; Cha, K. S.; Arora, C.; Bo, M.; Chae, J. K.; Aslam, M. S.; Bohmer, E.; Chalamidas, K.; Asselman, M.; Bollmann, A.; Challappa, K.; Audouin, P.; Bongiorni, M. G.; Chand, S. P.; Augenbraun, C.; Boriani, G.; Chandrashekar, H.; Aydin, S.; Boswijk, D. J.; Chartier, L.; Aydin, S.; Bott, J.; Chatterjee, K.; Ayryanova, I.; Bottacchi, E.; Ayala, C. A. C.; Cheema, A.; Davis, G.; Evonich, R.; Cheema, A.; Davy, J. -M.; Evseeva, O.; Chen, L.; Dayer, M.; Ezhov, A.; Chen, S. -A.; De Biasio, M.; Fahmy, R.; Chen, J. H.; De Bonis, S.; Fang, Q.; Chiang, F. -T.; De Caterina, R.; Farsad, R.; Chiarella, F.; De Franceschi, T.; Fauchier, L.; Chih-Chan, L.; de Groot, J. R.; Favale, S.; Cho, Y. K.; De Horta, J.; Fayard, M.; Choi, J. -I.; De La Briolle, A.; Fedele, J. L.; Choi, D. J.; de la Pena Topete, G.; Fedele, F.; Chouinard, G.; de Paola, A. A. V.; Fedorishina, O.; Chow, D. H. -F.; de Souza, W.; Fera, S. R.; Chrysos, D.; de Veer, A.; Ferreira, L. G. G.; Chumakova, G.; De Wolf, L.; Ferreira, J.; Valenzuela, E. J. J. R. C.; Decoulx, E.; Ferri, C.; Nica, N. C.; Deepak, S.; Ferrier, A.; Cislowski, D. J.; Defaye, P.; Ferro, H.; Clay, A.; Munoz, F. D. -C.; Finsen, A.; Clifford, P.; Brkljacic, D. D.; First, B.; Cohen, A.; Deumite, N. J.; Fischer, S.; Cohen, M.; Di Legge, S.; Fonseca, C.; Cohen, S.; Diemberger, I.; Almeida, L. F.; Colivicchi, F.; Dietz, D.; Forman, S.; Collins, R.; Dionisio, P.; Frandsen, B.; Colonna, P.; Dong, Q.; French, W.; Compton, S.; dos Santos, F. R.; Friedman, K.; Connolly, D.; Dotcheva, E.; Friese, A.; Conti, A.; Doukky, R.; Fruntelata, A. G.; Buenostro, G. C.; D'Souza, A.; Fujii, S.; Coodley, G.; Dubrey, S.; Fumagalli, S.; Cooper, M.; Ducrocq, X.; Fundamenski, M.; Coronel, J.; Dupljakov, D.; Furukawa, Y.; Corso, G.; Duque, M.; Gabelmann, M.; Sales, J. C.; Dutta, D.; Gabra, N.; Cottin, Y.; Duvilla, N.; Gadsboll, N.; Covalesky, J.; Duygun, A.; Galinier, M.; Cracan, A.; Dziewas, R.; Gammelgaard, A.; Crea, F.; Eaton, C. B.; Ganeshkumar, P.; Crean, P.; Eaves, W.; Gans, C.; Crenshaw, J.; Ebels-Tuinbeek, L. A.; Quintana, A. G.; Cullen, T.; Ehrlich, C.; Gartenlaub, O.; Darius, H.; Eichinger-Hasenauer, S.; Gaspardone, A.; Dary, P.; Eisenberg, S. J.; Genz, C.; Dascotte, O.; Jabali, A. E.; Georger, F.; Dauber, I.; Shahawy, M. E.; Georges, J. -L.; Davalos, V.; Hernandes, M. E.; Georgeson, S.; Davies, R.; Izal, A. E.; Giedrimas, E.; G
abstract

In this article, the name of the GLORIA-AF investigator Anastasios Kollias was given incorrectly as Athanasios Kollias in the Acknowledgements. The original article has been corrected.

2022 - Current status of reimbursement practices for remote monitoring of cardiac implantable electrical devices across Europe [Articolo su rivista]
Boriani, Giuseppe; Burri, Haran; Svennberg, Emma; Imberti, Jacopo Francesco; Merino, Josè Luis; Leclercq, Christophe
abstract

Remote monitoring (RM) of cardiac implantable electrical devices (CIEDs) is currently proposed as a standard of care for CIEDs follow-up, as recommended by major cardiology societies worldwide. By detecting a series of relevant device and patient-related parameters, RM is a valuable option for early detection of CIEDs' technical issues, as well as changes in parameters related to cardio-respiratory functions. Moreover, RM may allow longer spacing between in-office follow-ups and better organization of in-hospital resources. Despite these potential advantages, resulting in improved patient safety, we are still far from a widespread diffusion of RM across Europe. Reimbursement policies across Europe still show an important heterogeneity and have been considered as an important barrier to full implementation of RM as a standard for the follow-up of all the patients with pacemakers, defibrillators, devices for cardiac resynchronization, or implantable loop recorders. Indeed, in many countries, there are still inertia and unresponsiveness to the request for widespread implementation of RM for CIEDs, although an improvement was found in some countries as compared to years ago, related to the provision of some form of reimbursement. As a matter of fact, the COVID-19 pandemic has promoted an increased use of digital health for connecting physicians to patients, even if digital literacy may be a limit for the widespread implementation of telemedicine. CIEDs have the advantage of making possible RM with an already defined organization and reliable systems for data transmissions that can be easily implemented as a standard of care for present and future cardiology practice.

2022 - DIGItal Health Literacy after COVID-19 Outbreak among Frail and Non-Frail Cardiology Patients: The DIGI-COVID Study [Articolo su rivista]
Vitolo, Marco; Ziveri, Valentina; Gozzi, Giacomo; Busi, Chiara; Imberti, Jacopo Francesco; Bonini, Niccolò; Muto, Federico; Mei, Davide Antonio; Menozzi, Matteo; Mantovani, Marta; Cherubini, Benedetta; Malavasi, Vincenzo Livio; Boriani, Giuseppe
abstract

Background: Telemedicine requires either the use of digital tools or a minimum technological knowledge of the patients. Digital health literacy may influence the use of telemedicine in most patients, particularly those with frailty. We aimed to explore the association between frailty, the use of digital tools, and patients' digital health literacy. Methods: We prospectively enrolled patients referred to arrhythmia outpatient clinics of our cardiology department from March to September 2022. Patients were divided according to frailty status as defined by the Edmonton Frail Scale (EFS) into robust, pre-frail, and frail. The degree of digital health literacy was assessed through the Digital Health Literacy Instrument (DHLI), which explores seven digital skill categories measured by 21 self-report questions. Results: A total of 300 patients were enrolled (36.3% females, median age 75 (66-84)) and stratified according to frailty status as robust (EFS ≤ 5; 70.7%), pre-frail (EFS 6-7; 15.7%), and frail (EFS ≥ 8; 13.7%). Frail and pre-frail patients used digital tools less frequently and accessed the Internet less frequently compared to robust patients. In the logistic regression analysis, frail patients were significantly associated with the non-use of the Internet (adjusted odds ratio 2.58, 95% CI 1.92-5.61) compared to robust and pre-frail patients. Digital health literacy decreased as the level of frailty increased in all the digital domains examined. Conclusions: Frail patients are characterized by lower use of digital tools compared to robust patients, even though these patients would benefit the most from telemedicine. Digital skills were strongly influenced by frailty.

2022 - Determinants of worse prognosis in patients with cardiac resynchronization therapy defibrillators. Are ventricular arrhythmias an adjunctive risk factor? [Articolo su rivista]
Landolina, Maurizio; Boriani, Giuseppe; Biffi, Mauro; Cattafi, Giuseppe; Capucci, Alessandro; Dello Russo, Antonio; Facchin, Domenico; Rordorf, Roberto; Sagone, Antonio; Del Greco, Maurizio; Morani, Giovanni; Nicolis, Daniele; Meloni, Sarah; Grammatico, Andrea; Gasparini, Maurizio
abstract

Cardiac resynchronization therapy (CRT) is indicated in patients with systolic heart failure (HF), severe left ventricle (LV) dysfunction and interventricular dyssynchrony.In prospective observational research, we aimed to evaluate whether CRT-induced LV reverse remodelling and occurrence of ventricular arrhythmias (VT/VF) independently contribute to prognosis in patients with CRT defibrillators (CRT-D).

2022 - Dronedarone for the treatment of atrial fibrillation with concomitant heart failure and preserved or mildly reduced ejection fraction: closer to Ithaca after a long odyssey? [Articolo su rivista]
Boriani, G.; Imberti, J. F.; Vitolo, M.
abstract

2022 - Effectiveness of atrial fibrillation ablation in heart failure across the entire spectrum of left ventricular ejection fraction [Articolo su rivista]
Boriani, Giuseppe; Marcovitolo, ; Imberti, Jacopof.
abstract

2022 - Epidemiology and impact of frailty in patients with atrial fibrillation in Europe [Articolo su rivista]
Proietti, M.; Romiti, G. F.; Vitolo, M.; Harrison, S. L.; Lane, D. A.; Fauchier, L.; Marin, F.; Nabauer, M.; Potpara, T. S.; Dan, G. -A.; Maggioni, A. P.; Cesari, M.; Boriani, G.; Lip, G. Y. H.
abstract

BACKGROUND: Frailty is a medical syndrome characterised by reduced physiological reserve and increased vulnerability to stressors. Data regarding the relationship between frailty and atrial fibrillation (AF) are still inconsistent. OBJECTIVES: We aim to perform a comprehensive evaluation of frailty in a large European cohort of AF patients. METHODS: A 40-item frailty index (FI) was built according to the accumulation of deficits model in the AF patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry. Association of baseline characteristics, clinical management, quality of life, healthcare resources use and risk of outcomes with frailty was examined. RESULTS: Among 10,177 patients [mean age (standard deviation) 69.0 (11.4) years, 4,103 (40.3%) females], 6,066 (59.6%) were pre-frail and 2,172 (21.3%) were frail, whereas only 1,939 (19.1%) were considered robust. Baseline thromboembolic and bleeding risks were independently associated with increasing FI. Frail patients with AF were less likely to be treated with oral anticoagulants (OACs) (odds ratio 0.70, 95% confidence interval 0.55-0.89), especially with non-vitamin K antagonist OACs and managed with a rhythm control strategy, compared with robust patients. Increasing frailty was associated with a higher risk for all outcomes examined, with a non-linear exponential relationship. The use of OAC was associated with a lower risk of outcomes, except in patients with very/extremely high frailty. CONCLUSIONS: In this large cohort of AF patients, there was a high burden of frailty, influencing clinical management and risk of adverse outcomes. The clinical benefit of OAC is maintained in patients with high frailty, but not in very high/extremely frail ones.

2022 - Epidemiology of subclinical atrial fibrillation in patients with cardiac implantable electronic devices: A systematic review and meta-regression [Articolo su rivista]
Proietti, M.; Romiti, G. F.; Vitolo, M.; Borgi, M.; Rocco, A. D.; Farcomeni, A.; Miyazawa, K.; Healey, J. S.; Lane, D. A.; Boriani, G.; Basili, S.; Lip, G. Y. H.
abstract

Background: In recent years, attention to subclinical atrial fibrillation (SCAF), defined as the presence of atrial high-rate episodes (AHREs), in patients with cardiac implantable electronic devices (CIEDs), has gained much interest as a determinant of clinical AF and stroke risk. We aim to perform a systematic review and meta-regression of the available scientific evidence regarding the epidemiology of SCAF in patients receiving CIEDs. Methods: PubMed and EMBASE were searched for all studies documenting the prevalence of AHREs in patients (n=100 or more, <50% with history of AF) with CIEDs from inception to 20th August 2021, screened by two independent blind reviewers. This study was registered in PROSPERO: CRD42019106994. Results: Among the 2614 results initially retrieved, 54 studies were included, with a total of 72,784 patients. Meta-analysis of included studies showed a pooled prevalence of SCAF of 28.1% (95%CI: 24.3-32.1%), with high heterogeneity between studies (I2=98%). A multivariable meta-regression was able to explain significant proportion of heterogeneity (R2=61.9%, p<0.001), with age and follow-up time non-linearly, directly and independently associated with occurrence of SCAF. Older age, higher CHA2DS2-VASc score, history of AF, hypertension, CHF, and stroke/TIA were all associated with SCAF occurrence. Conclusions: In this systematic review and meta-regression analysis, SCAF was frequent among CIED recipients and was non-linearly associated with age and follow-up time. Older age, higher thromboembolic risk, and several cardiovascular comorbidities were associated with presence of SCAF.

2022 - Erratum: 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: Developed by the Task Force on cardiac pacing and cardiac resynchronization therapy of the European Society of Cardiology (ESC): With the special contribution of the European Heart Rhythm Association (EHRA) (Europace (2022) 24 (71–164) DOI: 10.1093/europace/euab232) [Articolo su rivista]
Glikson, M.; Nielsen, J. C.; Kronborg, M. B.; Michowitz, Y.; Auricchio, A.; Barbash, I. M.; Barrabs, J. A.; Boriani, G.; Braunschweig, F.; Brignole, M.; Burri, H.; Coats, A. J. S.; Deharo, J. -C.; Delgado, V.; Diller, G. -P.; Israel, C. W.; Keren, A.; Knops, R. E.; Kotecha, D.; Leclercq, C.; Merkely, B.; Starck, C.; Thyln, I.; Tolosana, J. M.
abstract

In the originally published version of thismanuscript, there were several errors which are listed in this corrigendumas follows: In Table 4, The Level of Evidence for "For venous access, the cephalic or axillary vein should be considered as first choice" should read "B" instead of "C". In Table 10, the wording "TAVI in valve in valve vs. native valve procedure" should read "TAVI in native valve vs. valve-in-valve procedure". In the Supplementary Data, the wording in Table 14 should read "TAVI in native valve vs. valve-in-valve procedure" instead of "TAVI in valve in valve vs. native valve procedure". These errors have now been corrected.

2022 - Erratum: Publisher's note to: Optimizing indices of atrial fibrillation susceptibility and burden to evaluate atrial fibrillation severity, risk and outcomes (Cardiovascular Research (cvab147) DOI: 10.1093/cvr/cvab147) [Articolo su rivista]
Boriani, G.; Vitolo, M.; Diemberger, I.; Proietti, M.; Valenti, A. C.; Malavasi, V. L.; Lip, G. Y. H.
abstract

This article should have published into Issue 117-7 of Cardiovascular Research as online-only content. However, it was accidentally omitted. The article has been added to the issue retrospectively and we have published this notice to highlight the emendation.

2022 - European Society of Cardiology Quality Indicators for the care and outcomes of cardiac pacing: developed by the Working Group for Cardiac Pacing Quality Indicators in collaboration with the European Heart Rhythm Association of the European Society of Cardiology [Articolo su rivista]
Aktaa, Suleman; Abdin, Amr; Arbelo, Elena; Burri, Haran; Vernooy, Kevin; Blomström-Lundqvist, Carina; Boriani, Giuseppe; Defaye, Pascal; Deharo, Jean-Claude; Drossart, Inga; Foldager, Dan; Gold, Michael R; Johansen, Jens Brock; Leyva, Francisco; Linde, Cecilia; Michowitz, Yoav; Kronborg, Mads Brix; Slotwiner, David; Steen, Torkel; Tolosana, José Maria; Tzeis, Stylianos; Varma, Niraj; Glikson, Michael; Nielsen, Jens Cosedis; Gale, Chris P
abstract

Aims: To develop a suite of quality indicators (QIs) for the evaluation of the care and outcomes for adults undergoing cardiac pacing. Methods and results: Under the auspice of the Clinical Practice Guideline Quality Indicator Committee of the European Society of Cardiology (ESC), the Working Group for cardiac pacing QIs was formed. The Group comprised Task Force members of the 2021 ESC Clinical Practice Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy, members of the European Heart Rhythm Association, international cardiac device experts, and patient representatives. We followed the ESC methodology for QI development, which involved (i) the identification of the key domains of care by constructing a conceptual framework of the management of patients receiving cardiac pacing, (ii) the development of candidate QIs by conducting a systematic review of the literature, (iii) the selection of the final set of QIs using a modified-Delphi method, and (iv) the evaluation of the feasibility of the developed QIs. Four domains of care were identified: (i) structural framework, (ii) patient assessment, (iii) pacing strategy, and (iv) clinical outcomes. In total, seven main and four secondary QIs were selected across these domains and were embedded within the 2021 ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization therapy. Conclusion: By way of a standardized process, 11 QIs for cardiac pacing were developed. These indicators may be used to quantify adherence to guideline-recommended clinical practice and have the potential to improve the care and outcomes of patients receiving cardiac pacemakers.

2022 - Evaluation and management of cancer patients presenting with acute cardiovascular disease: a Clinical Consensus Statement of the Acute CardioVascular Care Association (ACVC) and the ESC council of Cardio-Oncology-part 2: acute heart failure, acute myocardial diseases, acute venous thromboembolic diseases, and acute arrhythmias [Articolo su rivista]
Gevaert, Sofie A; Halvorsen, Sigrun; Sinnaeve, Peter R; Sambola, Antonia; Gulati, Geeta; Lancellotti, Patrizio; Van Der Meer, Peter; Lyon, Alexander R; Farmakis, Dimitrios; Lee, Geraldine; Boriani, Giuseppe; Wechalekar, Ashutosh; Okines, Alicia; Asteggiano, Riccardo; Combes, Alain; Pfister, Roman; Bergler-Klein, Jutta; Lettino, Maddalena
abstract

Advances in treatment, common cardiovascular (CV) risk factors and the ageing of the population have led to an increasing number of cancer patients presenting with acute CV diseases. These events may be related to cancer itself or cancer treatment. Acute cardiac care specialists must be aware of these acute CV complications and be able to manage them. This may require an individualized and multidisciplinary approach. The management of acute coronary syndromes and acute pericardial diseases in cancer patients was covered in part 1 of a clinical consensus document. This second part focusses on acute heart failure, acute myocardial diseases, venous thromboembolic diseases and acute arrhythmias.

2022 - Feasible approaches and implementation challenges to atrial fibrillation screening: A qualitative study of stakeholder views in 11 European countries [Articolo su rivista]
Engler, Daniel; L Hanson, Coral; Desteghe, Lien; Boriani, Giuseppe; Zöga Diederichsen, Søren; Freedman, Ben; Palà, Elena; S Potpara, Tatjana; Witt, Henning; Heidbuchel, Hein; Neubeck, Lis; B Schnabel, Renate
abstract

Objectives Atrial fibrillation (AF) screening may increase early detection and reduce complications of AF. European, Australian and World Heart Federation guidelines recommend opportunistic screening, despite a current lack of clear evidence supporting a net benefit for systematic screening. Where screening is implemented, the most appropriate approaches are unknown. We explored the views of European stakeholders about opportunities and challenges of implementing four AF screening scenarios. Design Telephone-based semi-structured interviews with results reported using Consolidated criteria for Reporting Qualitative research guidelines. Data were thematically analysed using the framework approach. Setting AF screening stakeholders in 11 European countries. Participants Healthcare professionals and regulators (n=24) potentially involved in AF screening implementation. Intervention Four AF screening scenarios: single time point opportunistic, opportunistic prolonged, systematic single time point/prolonged and patient-led screening. Primary outcome measures Stakeholder views about the challenges and feasibility of implementing the screening scenarios in the respective national/regional healthcare system. Results Three themes developed. (1) Current screening approaches: there are no national AF screening programmes, with most AF detected in symptomatic patients. Patient-led screening exists via personal devices, creating screening inequity. (2) Feasibility of screening: single time point opportunistic screening in primary care using single-lead ECG devices was considered the most feasible. Software algorithms may aid identification of suitable patients and telehealth services have potential to support diagnosis. (3) Implementation requirements: sufficient evidence of benefit is required. National screening processes are required due to different payment mechanisms and health service regulations. Concerns about data security, and inclusivity for those without primary care access or personal devices must be addressed. Conclusions There is an overall awareness of AF screening. Opportunistic screening appears the most feasible across Europe. Challenges are health inequalities, identification of best target groups for screening, streamlined processes, the need for evidence of benefit and a tailored approach adapted to national realities.

2022 - Frailty prevalence and impact on outcomes in patients with atrial fibrillation: A systematic review and meta-analysis of 1,187,000 patients [Articolo su rivista]
Proietti, Marco; Romiti, Giulio Francesco; Raparelli, Valeria; Diemberger, Igor; Boriani, Giuseppe; Vecchia, Laura Adelaide Dalla; Bellelli, Giuseppe; Marzetti, Emanuele; Lip, Gregory Yh; Cesari, Matteo
abstract

: Frailty is a clinical syndrome characterized by a reduced physiologic reserve, increased vulnerability to stressors and an increased risk of adverse outcomes. People with atrial fibrillation (AF) are often burdened by frailty due to biological, clinical, and social factors. The prevalence of frailty, its management and association with major outcomes in AF patients are still not well quantified. We systematically searched PubMed and EMBASE, from inception to September 13th, 2021, for studies reporting the prevalence of frailty in AF patients. The study was registered in PROSPERO (CRD42021235854). 33 studies were included in the systematic review (n = 1,187,651 patients). The frailty pooled prevalence was 39.7 % (95 %CI=29.9 %-50.5 %, I2 =100 %), while meta-regression analyses showed it is influenced by age, history of stroke, and geographical location. Meta-regression analyses showed that OAC prescription was influenced by study-level mean age, baseline thromboembolic risk, and study setting. Frail AF patients were associated with a higher risk of all-cause death (OR=5.56, 95 %CI=3.46-8.94), ischemic stroke (OR=1.59, 95 %CI=1.00-2.52), and bleeding (OR=1.64, 95 %CI=1.11-2.41), when compared to robust individuals. In this systematic review and meta-analysis, the prevalence of frailty was high in patients with AF. Frailty may influence the prognosis and management of AF patients, thus requiring person-tailored interventions in a holistic or integrated approach to AF care.

2022 - Guía ESC 2021 sobre estimulación cardiaca y terapia de resincronización [Articolo su rivista]
Glikson, M.; Nielsen, J. C.; Kronborg, M. B.; Michowitz, Y.; Auricchio, A.; Barbash, I. M.; Barrabes, J. A.; Boriani, G.; Braunschweig, F.; Brignole, M.; Burri, H.; Coats, A. J. S.; Deharo, J. -C.; Delgado, V.; Diller, G. -P.; Israel, C. W.; Keren, A.; Knops, R. E.; Kotecha, D.; Leclercq, C.; Merkely, B.; Starck, C.; Thylen, I.; Tolosana, J. M.
abstract

2022 - How to use digital devices to detect and manage arrhythmias: an EHRA practical guide [Articolo su rivista]
Svennberg, Emma; Tjong, Fleur; Goette, Andreas; Akoum, Nazem; Di Biase, Luigi; Bordachar, Pierre; Boriani, Giuseppe; Burri, Haran; Conte, Giulio; Deharo, Jean-Claude; Deneke, Thomas; Drossart, Inga; Duncker, David; Han, Janet K; Heidbuchel, Hein; Jais, Pierre; de Oliviera Figueiredo, Marcio Jansen; Linz, Dominik; Lip, Gregory Y H; Malaczynska-Rajpold, Katarzyna; Márquez, Manlio; Ploem, Corrette; Soejima, Kyoko; Stiles, Martin K; Wierda, Eric; Vernooy, Kevin; Leclercq, Christophe; Meyer, Christian; Pisani, Cristiano; Pak, Hui-Nam; Gupta, Dhiraj; Pürerfellner, Helmut; Crijns, H J G M; Chavez, Edgar Antezana; Willems, Stephan; Waldmann, Victor; Dekker, Lukas; Wan, Elaine; Kavoor, Pramesh; Turagam, Mohit K; Sinner, Moritz
abstract

2022 - Impact of COVID-19 in emergency medicine literature: a bibliometric analysis [Articolo su rivista]
Vitolo, M.; Venturelli, A.; Valenti, A. C.; Boriani, G.
abstract

2022 - Impact of anthropometric factors on outcomes in atrial fibrillation patients: analysis on 10 220 patients from the European Society of Cardiology (ESC)-European Heart Rhythm Association (EHRA) EurObservational Research Programme on Atrial Fibrillation (EORP-AF) general long-term registry [Articolo su rivista]
Boriani, Giuseppe; Vitolo, Marco; Malavasi, Vincenzo L; Proietti, Marco; Fantecchi, Elisa; Diemberger, Igor; Fauchier, Laurent; Marin, Francisco; Nabauer, Michael; Potpara, Tatjana S; Dan, Gheorghe-Andrei; Kalarus, Zbigniew; Tavazzi, Luigi; Maggioni, Aldo Pietro; Lane, Deirdre A; Lip, Gregory Y H
abstract

Aim: To investigate the association of anthropometric parameters [height, weight, body mass index (BMI), body surface area (BSA) and lean body mass (LBM)] with outcomes in atrial fibrillation (AF). Methods and results: 10220 patients were enrolled [40.3% females, median age 70 (62-77) years, followed for 728 (IQR 653-745) days]. Sex-specific tertiles were considered for the 5 anthropometric variables. At the end of follow-up survival free from all-cause death was worse in the lowest tertiles for all the anthropometric variables analyzed. On multivariable Cox regression analysis, an independent association with all-cause death was found for the lowest vs. middle tertile when body weight (hazard ratio [HR] 1.66, 95%CI 1.23-2.23), BMI (HR 1.65, 95%CI 1.23-2.21), BSA (HR 1.49, 95%CI 1.11-2.01) were analysed in female sex, as well as for body weight in male patients (HR 1.61, 95%CI 1.25-2 .07). Conversely, the risk of MACE was lower for the highest tertile (vs. middle tertile) of BSA and LBM in males and for the highest tertile of weight and BSA in female patients. A higher occurrence of hemorrhagic events was found for female patients in the lowest tertile of height [odds ratio (OR) 1.90, 95%CI 1.23-2.94] and LBM (OR 2.13, 95%CI 1.40-3.26).  . Conclusions: In AF patients height, weight, BMI, BSA and LBM were associated with clinical outcomes, with all-cause death being higher for patients presenting lower values of these variables, i.e in the lowest tertiles of distribution. The anthropometric variables independently associated with other outcomes were also different between male and female subjects.

2022 - Impact of body mass index on the outcome of elderly patients treated with transcatheter aortic valve implantation [Articolo su rivista]
Sgura, F. A.; Arrotti, S.; Monopoli, D.; Valenti, A. C.; Vitolo, M.; Magnavacchi, P.; Tondi, S.; Gabbieri, D.; Guiducci, V.; Benatti, G.; Vignali, L.; Rossi, R.; Boriani, G.
abstract

Underweight or overweight patients with cardiovascular diseases are associated with different outcomes. However, the data on the relation between body mass index (BMI) and outcomes after transcatheter aortic valve implantation (TAVI) are not homogeneous. The aim of this study was to assess the role of low BMI on short and long-term mortality in real-world patients undergoing TAVI. We retrospectively included patients undergoing TAVI for severe aortic valve stenosis. Patients were classified into three BMI categories: underweight (< 20 kg/m2), normal weight (20–24.9 kg/m2) and overweight/obese (≥ 25 kg/m2). Our primary endpoint was long-term all-cause mortality. The secondary endpoint was 30-day all-cause mortality. A total of 794 patients were included [mean age 82.3 ± 5.3, 53% females]. After a median follow-up of 2.2 years, all-cause mortality was 18.1%. Patients in the lowest BMI group showed a higher mortality rate as compared to those with higher BMI values. At the multivariate Cox regression analysis, as compared to the normal BMI group, BMI < 20 kg/m2 was associated with long-term mortality independently of baseline risk factors and postprocedural adverse events (hazard ratio [HR] 2.29, 95% confidence interval [CI] 1.30–4.03] and HR 2.61, 95% CI 1.48–4.60, respectively). The highest BMI values were found to be protective for both short- and long-term mortality as compared to lower BMI values even after applying the same adjustments. In our cohort, BMI values under 20 kg/m2 were independent predictors of increased long-term mortality. Conversely, the highest BMI values were associated with lower mortality rates both at short- and long-term follow-up.

2022 - Impact of diabetes on the management and outcomes in atrial fibrillation: an analysis from the ESC-EHRA EORP-AF Long-Term General Registry [Articolo su rivista]
Ding, W. Y.; Kotalczyk, A.; Boriani, G.; Marin, F.; Blomstrom-Lundqvist, C.; Potpara, T. S.; Fauchier, L.; Lip, G. Y. H.
abstract

Background: The prevalence of atrial fibrillation(AF) and diabetes mellitus is rising to epidemic proportions. We aimed to assess the impact of diabetes on the management and outcomes of patients with AF. Methods: The EORP-AF General Long-Term Registry is a prospective, observational registry from 250 centres across 27 European countries. Outcomes of interest were as follows: i)rhythm control interventions; ii)quality of life; iii)healthcare resource utilisation; and iv)major adverse events. Results: Of 11,028 patients with AF, the median age was 71 (63–77) years and 2537 (23.0%) had diabetes. Median follow-up was 24 months. Diabetes was related to increased use of anticoagulation but less rhythm control interventions. Using multivariable analysis, at 2-year follow-up, patients with diabetes were associated with greater levels of anxiety (p = 0.038) compared to those without diabetes. Overall, diabetes was associated with worse health during follow-up, as indicated by Health Utility Score and Visual Analogue Scale. Healthcare resource utilisation was greater with diabetes in terms of length of hospital stay (8.1 (±8.2) vs. 6.1 (±6.7) days); cardiology and internal medicine/general practitioner visits; and emergency room admissions. Diabetes was an independent risk factor of major adverse cardiovascular event (MACE; HR 1.26 [95% CI, 1.04–1.52]), all-cause mortality (HR 1.28 [95% CI, 1.08–1.52]), and cardiovascular mortality (HR 1.41 [95% CI, 1.09–1.83]). Conclusion: In this contemporary AF cohort, diabetes was present in 1 in 4 patients and it served as an independent risk factor for reduced quality of life, greater healthcare resource utilisation and excess MACE, all-cause mortality and cardiovascular mortality. There was increased use of anticoagulation therapy in diabetes but with less rhythm control interventions.

2022 - Impact of malignancy on outcomes in European patients with atrial fibrillation: A report from the ESC-EHRA EURObservational research programme in atrial fibrillation general long-term registry [Articolo su rivista]
Malavasi, Vincenzo L; Vitolo, Marco; Proietti, Marco; Diemberger, Igor; Fauchier, Laurent; Marin, Francisco; Nabauer, Michael; Potpara, Tatjana S; Dan, Gheorghe-Andrei; Kalarus, Zbigniew; Tavazzi, Luigi; Maggioni, Aldo Pietro; Lane, Deirdre A; Lip, Gregory Y H; Boriani, Giuseppe
abstract

Background: The management of patients with atrial fibrillation (AF) and malignancy is challenging given the paucity of evidence supporting their appropriate clinical management.Purpose: To evaluate the outcomes of patients with active or prior malignancy in a contemporary cohort of European AF patients.Methods: Patients enrolled in the EURObservational Research Programme in AF General Long-Term Registry were categorized into 3 categories: No Malignancy (NoMal), Prior Malignancy (PriorMal) and Active Malignancy (ActiveMal). The primary outcomes were all-cause death and the composite outcome MACE.Results: A total of 10 383 patients were analysed. Of these, 9597 (92.4%) were NoMal patients, 577 (5.6%) PriorMal and 209 (2%) ActiveMal. Lack of any antithrombotic treatment was more prevalent in ActiveMal patients (12.4%) as compared to other groups (5.0% vs 6.3% for PriorMal and NoMal, p <.001). After a median follow-up of 730 days, there were 982 (9.5%) deaths and 950 (9.7%) MACE events. ActiveMal was independently associated with a higher risk for all-cause death (HR 2.90, 95% CI 2.23-3.76) and MACE (HR 1.54, 95% CI 1.03-2.31), as well as any haemorrhagic events and major bleeding (OR 2.42, 95% CI 1.49-3.91 and OR 4.18, 95% CI 2.49-7.01, respectively). Use of oral anticoagulants was not significantly associated with a higher risk for all-cause death or bleeding in ActiveMal patients.Conclusions: In a large contemporary cohort of AF patients, active malignancy was independently associated with all-cause death, MACE and haemorrhagic events. Use of anticoagulants was not associated with a higher risk of all-cause death in patients with active malignancies.

2022 - Impact of renal impairment on atrial fibrillation: ESC-EHRA EORP-AF Long-Term General Registry [Articolo su rivista]
Ding, W. Y.; Potpara, T. S.; Blomstrom-Lundqvist, C.; Boriani, G.; Marin, F.; Fauchier, L.; Lip, G. Y. H.
abstract

BACKGROUND: Atrial fibrillation (AF) and renal impairment share a bidirectional relationship with important pathophysiological interactions. We evaluated the impact of renal impairment in a contemporary cohort of patients with AF. METHODS: We utilised the ESC-EHRA EORP-AF Long-Term General Registry. Outcomes were analysed according to renal function by CKD-EPI equation. The primary endpoint was a composite of thromboembolism, major bleeding, acute coronary syndrome and all-cause death. Secondary endpoints were each of these separately including ischaemic stroke, haemorrhagic event, intracranial haemorrhage, cardiovascular death and hospital admission. RESULTS: A total of 9306 patients were included. The distribution of patients with no, mild, moderate and severe renal impairment at baseline were 16.9%, 49.3%, 30% and 3.8%, respectively. AF patients with impaired renal function were older, more likely to be females, had worse cardiac imaging parameters and multiple comorbidities. Among patients with an indication for anticoagulation, prescription of these agents was reduced in those with severe renal impairment, p < .001. Over 24 months, impaired renal function was associated with significantly greater incidence of the primary composite outcome and all secondary outcomes. Multivariable Cox regression analysis demonstrated an inverse relationship between eGFR and the primary outcome (HR 1.07 [95% CI, 1.01-1.14] per 10 ml/min/1.73 m2 decrease), that was most notable in patients with eGFR <30 ml/min/1.73 m2 (HR 2.21 [95% CI, 1.23-3.99] compared to eGFR ≥90 ml/min/1.73 m2 ). CONCLUSION: A significant proportion of patients with AF suffer from concomitant renal impairment which impacts their overall management. Furthermore, renal impairment is an independent predictor of major adverse events including thromboembolism, major bleeding, acute coronary syndrome and all-cause death in patients with AF.

2022 - Implantable cardioverter defibrillators and devices for cardiac resynchronization therapy: what perspective for patients’ apps combined with remote monitoring? [Articolo su rivista]
Sgreccia, D.; Mauro, E.; Vitolo, M.; Manicardi, M.; Valenti, A. C.; Imberti, J. F.; Ziacchi, M.; Boriani, G.
abstract

Introduction: Remote monitoring (RM) of cardiac implantable electronic devices (CIED) allows rapid detection of clinical and electrical events. Recently, several smartphone applications have been developed with the aim of improving patient compliance and better interpreting and integrating data deriving from remote control for the management of heart failure (HF). Areas covered: Studies investigating the role of CIEDs’ RM in HF patients to predict and early treat acute decompensation. The importance of new technologies and applications developed to provide crucial information to clinicians, to better manage HF patients. Expert opinion: New medical technologies and smartphone applications for CIEDs’ RM were developed to help clinicians in the management of CIED carriers. Indeed, the accessibility of technological devices (e.g. smartphones) and the improvements in medical technology provide the opportunity to optimize HF patients’ monitoring by the transmission of device-related data, and with direct involvement of patients themselves. Thanks to these advancements, physicians have the possibility to recognize worsening signs of HF and promptly optimize treatments to potentially avoid hospitalization. The great value of this approach is its potential of reducing scheduled in-office visits or unnecessary medical contacts and optimizing healthcare resources management.

2022 - Implantable cardioverter-defibrillators for primary prevention of sudden cardiac death: what are the barriers to implementation in the ‘real world’? [Articolo su rivista]
Boriani, G.; Vitolo, M.; Leyva, F.
abstract

2022 - Incidence and Predictors of Infections and All-Cause Death in Patients with Cardiac Implantable Electronic Devices: The Italian Nationwide RI-AIAC Registry [Articolo su rivista]
Boriani, G.; Proietti, M.; Bertini, M.; Diemberger, I.; Palmisano, P.; Baccarini, S.; Biscione, F.; Bottoni, N.; Ciccaglioni, A.; Monte, A. D.; Ferrari, F. A.; Iacopino, S.; Piacenti, M.; Porcelli, D.; Sangiorgio, S.; Santini, L.; Malagu, M.; Stabile, G.; Imberti, J. F.; Caruso, D.; Zoni-Berisso, M.; De Ponti, R.; Ricci, R. P.
abstract

Background: The incidence of infections associated with cardiac implantable electronic devices (CIEDs) and patient outcomes are not fully known. Aim: To provide a contemporary assessment of the risk of CIEDs infection and associated clinical outcomes. Methods: In Italy, 18 centres enrolled all consecutive patients undergoing a CIED procedure and entered a 12-months follow-up. CIED infections, as well as a composite clinical event of infection or all-cause death were recorded. Results: A total of 2675 patients (64.3% male, age 78 (70–84)) were enrolled. During follow up 28 (1.1%) CIED infections and 132 (5%) deaths, with 152 (5.7%) composite clinical events were observed. At a multivariate analysis, the type of procedure (revision/upgrading/reimplantation) (OR: 4.08, 95% CI: 1.38–12.08) and diabetes (OR: 2.22, 95% CI: 1.02–4.84) were found as main clinical factors associated to CIED infection. Both the PADIT score and the RI-AIAC Infection score were significantly associated with CIED infections, with the RI-AIAC infection score showing the strongest association (OR: 2.38, 95% CI: 1.60–3.55 for each point), with a c-index = 0.64 (0.52–0.75), p = 0.015. Regarding the occurrence of composite clinical events, the Kolek score, the Shariff score and the RI-AIAC Event score all predicted the outcome, with an AUC for the RI-AIAC Event score equal to 0.67 (0.63−0.71) p < 0.001. Conclusions: In this Italian nationwide cohort of patients, while the incidence of CIED infections was substantially low, the rate of the composite clinical outcome of infection or all-cause death was quite high and associated with several clinical factors depicting a more impaired clinical status.

2022 - Integrated care for optimizing the management of stroke and associated heart disease: a position paper of the European Society of Cardiology Council on Stroke [Articolo su rivista]
Lip, Gregory Y H; Lane, Deirdre A; Lenarczyk, Radosław; Boriani, Giuseppe; Doehner, Wolfram; Benjamin, Laura A; Fisher, Marc; Lowe, Deborah; Sacco, Ralph L; Schnabel, Renate; Watkins, Caroline; Ntaios, George; Potpara, Tatjana
abstract

The management of patients with stroke is often multidisciplinary, involving various specialties and healthcare professionals. Given the common shared risk factors for stroke and cardiovascular disease, input may also be required from the cardiovascular teams, as well as patient caregivers and next-of-kin. Ultimately, the patient is central to all this, requiring a coordinated and uniform approach to the priorities of post-stroke management, which can be consistently implemented by different multidisciplinary healthcare professionals, as part of the patient 'journey' or 'patient pathway,' supported by appropriate education and tele-medicine approaches. All these aspects would ultimately aid delivery of care and improve patient (and caregiver) engagement and empowerment. Given the need to address the multidisciplinary approach to holistic or integrated care of patients with heart disease and stroke, the European Society of Cardiology Council on Stroke convened a Task Force, with the remit to propose a consensus on Integrated care management for optimizing the management of stroke and associated heart disease. The present position paper summarizes the available evidence and proposes consensus statements that may help to define evidence gaps and simple practical approaches to assist in everyday clinical practice. A post-stroke ABC pathway is proposed, as a more holistic approach to integrated stroke care, would include three pillars of management: center dot A: Appropriate Antithrombotic therapy. center dot B: Better functional and psychological status. center dot C: Cardiovascular risk factors and Comorbidity optimization (including lifestyle changes).

2022 - Kidney Function According to Different Equations in Patients Admitted to a Cardiology Unit and Impact on Outcome [Articolo su rivista]
Malavasi, V. L.; Valenti, A. C.; Ruggerini, S.; Manicardi, M.; Orlandi, C.; Sgreccia, D.; Vitolo, M.; Proietti, M.; Lip, G. Y. H.; Boriani, G.
abstract

Background: This paper aims to evaluate the concordance between the Chronic Kidney Disease Epidemiology Collaboration (CKD‐EPI) formula and alternative equations and to assess their predictive power for all‐cause mortality in unselected patients discharged alive from a cardiology ward. Methods: We retrospectively included patients admitted to our Cardiology Division independently of their diagnosis. The total population was classified according to Kidney Disease: Improving Global Outcomes (KDIGO) categories, as follows: G1 (estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m2); G2 (eGFR 89–60 mL/min/1.73 m2); G3a (eGFR 59–45 mL/min/1.73 m2); G3b (eGFR 44–30 mL/min/1.73 m2); G4 (eGFR 29–15 mL/min/1.73 m2); G5 (eGFR < 15 mL/min/1.73 m2). Cockcroft‐Gault (CG), CG adjusted for body surface area (CG‐BSA), Modification of Diet in Renal Disease (MDRD), Berlin Initiative Study (BIS‐1), and Full Age Spectrum (FAS) equations were also assessed. Results: A total of 806 patients were included. Good agreement was found between the CKD‐EPI formula and CG‐BSA, MDRD, BIS‐1, and FAS equations. In subjects younger than 65 years or aged ≥85 years, CKD‐EPI and MDRD showed the highest agreement (Cohen’s kappa (K) 0.881 and 0.588, respectively) while CG showed the lowest. After a median follow‐up of 407 days, overall mortality was 8.2%. The risk of death was higher in lower eGFR classes (G3b HR4.35; 95%CI 1.05–17.80; G4 HR7.13; 95%CI 1.63–31.23; G5 HR25.91; 95%CI 6.63–101.21). The discriminant capability of death prediction tested with ROC curves showed the best results for BIS‐1 and FAS equations. Conclusion: In our cohort, the concordance between CKD‐EPI and other equations decreased with age, with the MDRD formula showing the best agreement in both younger and older patients. Overall, mortality rates increased with the renal function decreasing. In patients aged ≥75 years, the best discriminant capability for death prediction was found for BIS‐1 and FAS equations.

2022 - Letter by Imberti et al Regarding Article, "DREAM-ICD-II Study" [Articolo su rivista]
Imberti, J. F.; Vitolo, M.; Boriani, G.
abstract

2022 - Low Levels of Vitamin D and Silent Myocardial Ischemia in Type 2 Diabetes: Clinical Correlations and Prognostic Significance [Articolo su rivista]
Rossi, R.; Talarico, M.; Pascale, A.; Pascale, V.; Minici, R.; Boriani, G.
abstract

Vitamin D deficiency has a pathogenetic and prognostic role in coronary artery disease and a key role in pain transmission. Diabetic patients have a higher risk of silent myocardial ischemia (SMI) due to diabetic neuropathy. We evaluated the correlation between SMI and Vitamin D serum levels in type 2 diabetic patients and assessed whether SMI patients had a worse survival rate than their symptomatic counterpart. We enrolled 253 patients admitted in our Cardiology Unit and compared them with 50 healthy volunteers. We created three sub-groups: symptomatic MI group (125, 32.4%); SMI group (78, 25.7%), and no-MI group (50, 41.9%). 25(OH)D levels (nmol/L) were lower in the SMI group (34.9 ± 5.8) compared to those in the symptomatic MI (49.6 ± 6.1; p = 0.01), no MI (53.1 ± 6.2; p = 0.001), and control groups (62.1 ± 6.7; p = 0.0001). 25(OH)D levels predicted SMI in diabetic patients, with an inverted odds ratio of 1.11 (p = 0.01). Symptomatic MI group survival was higher than the SMI one (6-year survival rate: 83 vs. 69%; p = 0.01). Diabetic patients with SMI had a higher mortality risk and showed lower 25(OH)D levels than the symptomatic group. This suggests the crucial role that vitamin D has in the pathogenesis of SMI.

2022 - Mobile health technology in atrial fibrillation [Articolo su rivista]
Bonini, Niccolò; Vitolo, Marco; Imberti, Jacopo Francesco; Proietti, Marco; Romiti, Giulio Francesco; Boriani, Giuseppe; Paaske Johnsen, Søren; Guo, Yutao; Lip, Gregory Y H
abstract

Introduction Mobile health (mHealth) solutions in atrial fibrillation (AF) are becoming widespread, thanks to everyday life devices, such as smartphones. Their use is validated both in monitoring and in screening scenarios. In the published literature, the diagnostic accuracy of mHealth solutions wide differs, and their current clinical use is not well established in principal guidelines. Areas covered mHealth solutions have progressively built an AF-detection chain to guide patients from the device's alert signal to the health-care practitioners' (HCPs) attention. This review aims to critically evaluate the latest evidence regarding mHealth devices and the future possible patient's uses in everyday life. Expert opinion The patients are the first to be informed of the rhythm anomaly, leading to the urgency of increasing the patients' AF self-management. Furthermore, HCPs need to update themselves about mHealth devices use in clinical practice. Nevertheless, these are promising instruments in specific populations, such as post-stroke patients, to promote an early arrhythmia diagnosis in the post-ablation/cardioversion period, allowing checks on the efficacy of the treatment or intervention.

2022 - Performance-based risk-sharing arrangements for devices and procedures in cardiac electrophysiology: an innovative perspective [Articolo su rivista]
Boriani, Giuseppe; Vitolo, Marco; Svennberg, Emma; Casado-Arroyo, Ruben; Merino, Josè L; Leclercq, Christophe
abstract

There is an increasing pressure on demonstrating the value of medical interventions and medical technologies resulting in the proposal of new approaches for implementation in the daily practice of innovative treatments that might carry a substantial cost. While originally mainly adopted by pharmaceutical companies, in recent years medical technology companies have initiated novel value-based arrangements for using medical devices, in the form of 'outcomes-based contracts', 'performance-based contracts', or 'risk-sharing agreements'. These are all characterized by linking coverage, reimbursement, or payment for the innovative treatment to the attainment of pre-specified clinical outcomes. Risk-sharing agreements have been promoted also in the field of electrophysiology and offer the possibility to demonstrate the value of specific innovative technologies proposed in this rapidly advancing field, while relieving hospitals from taking on the whole financial risk themselves. Physicians deeply involved in the field of devices and technologies for arrhythmia management and invasive electrophysiology need to be prepared for involvement as stakeholders. This may imply engagement in the evaluation of risk-sharing agreements and specifically, in the process of assessment of technology performances or patient outcomes. Scientific Associations may have an important role in promoting the basis for value-based assessments, in promoting educational initiatives to help assess the determinants of the learning curve for innovative treatments, and in promoting large-scale registries for a precise assessment of patient outcomes and of specific technologies' performance.

2022 - Personalizing configuration for atrial fibrillation external electrical cardioversion to improve first shock efficacy [Articolo su rivista]
Massaro, Giulia; Spagni, Stefano; Martignani, Cristian; Bettazzoni, Luca; Spadotto, Alberto; Ziacchi, Matteo; Biffi, Mauro; Galiè, Nazzareno; Boriani, Giuseppe; Frisoni, Jessica; Diemberger, Igor
abstract

Background Despite the common use of biphasic electrical cardioversion (ECV) to convert atrial fibrillation (AF), we lack definite recommendations on electrode configuration. Methods We adopted a quasi-experimental design enrolling all candidates to ECV for AF. In the first stage, two units were involved, one using antero-apical pads (AAP) and the second antero-posterior adhesive patches (APP). These data enabled the creation of a decision algorithm to personalize the ECV approach, which was subsequently validated during the second stage. Results A total of 492 patients were enrolled overall. In the first stage, APP and AAP presented similar conversion rates (87.4 vs. 86.9% at first attempt of a step-up protocol, P = 0.661). While body surface area (BSA) <= 2.12 m(2) was an independent predictor in the overall population, the two components (height and weight) acted differently in the two configurations: being height <= 1.73 m(2) a significant cut-off value in the AAP subgroup, and weight <83 kg in the APP subgroup. Considering these cut-offs, we developed a decision algorithm for electrode configuration. In the second stage, algorithm validation confirmed an improvement in the first shock efficacy with respect to the results of the first stage (93.2 vs. 87.2%, P = 0.025), with a significant reduction in shock impedance (70.8 +/- 15.3 vs. 81.8 +/- 15.6, P < 0.001). Conclusion Patients with high BSA require high energy shocks for sinus rhythm restoration with ECV. Weight seems to affect more APP configuration, while height seems to impact more for the AAP. These findings have the potential to optimize ECV in clinical practice.

2022 - Preoperative checklist to reduce the risk of cardiac implantable electronic device infections [Articolo su rivista]
Ziacchi, M.; Massaro, G.; Angeletti, A.; Statuto, G.; Diemberger, I.; Martignani, C.; Galie, N.; Biffi, M.; Boriani, G.
abstract

Cardiac implantable electronic device (CIED) infection represents a dramatic event with a high mortality rate (>3x) despite antibiotic therapy and device extraction; therefore, the real winning strategy in this situation could be represented by prevention. Antibiotic prophylaxis and antibiotic-releasing envelope are effective in improving patient outcome; however, healthcare costs related to CIED infections remain high over the years. In this review we would keep the attention on a pre-surgical checklist to reduce the risk of CIED infections. In fact, checklist is an effective instrument for medical care quality improvement mainly used in surgery, but not very commonly in cath-lab and electrophysiology procedures. All steps of this checklist are of proven effectiveness in reducing the risk of CIED infections but, up till now, they are not considered together in a pre-surgical approach.

2022 - Prognostic value of renal failure in patients undergoing transvenous lead extraction: single centre experience and systematic review of the literature [Articolo su rivista]
Massaro, G.; Spadotto, A.; Canovi, L.; Martignani, C.; Ziacchi, M.; Angeletti, A.; Galie, N.; Boriani, G.; Biffi, M.; Diemberger, I.
abstract

Introduction: Cardiac implantable electronic device infections (CIEDI) are challenging complications, associated with high mortality rate. Transvenous lead extraction (TLE) is the only curative treatment for CIEDI. Albeit continuous improvement in tools and techniques dramatically decreased TLE associated complications, survival after TLE for CIEDI is still poor. Renal failure (RF) is frequently reported in candidates to TLE, but due to variability in its definition, the real prevalence is not well defined. Objective: Considering the impact of RF on mortality among patients affected by cardiovascular diseases, we aimed our research at defining the role of RF as a predictor of post-TLE mortality. Method and Results: We will provide the results of a systematic revision of literature on the impact of RF on mortality at different time points after TLE, according to the various definitions adopted for RF. Considering the high variability of literature in this field, we will provide the results of an explorative analysis comparing the different definitions of RF on clinical outcomes in a cohort of candidates to TLE for CIEDI in a high-volume referral center. Conclusion: We discuss the possible reasons of the negative impact of RF after TLE, providing new perspectives for future research.

2022 - Pulmonary arterial hypertension and right ventricular systolic dysfunction in COVID-19 survivors [Articolo su rivista]
Rossi, R.; Coppi, F.; Monopoli, D. E.; Sgura, F. A.; Arrotti, S.; Boriani, G.
abstract

2022 - Real-world applicability and impact of early rhythm control for European patients with atrial fibrillation: a report from the ESC-EHRA EORP-AF Long-Term General Registry [Articolo su rivista]
Proietti, M.; Vitolo, M.; Harrison, S. L.; Lane, D. A.; Fauchier, L.; Marin, F.; Nabauer, M.; Potpara, T. S.; Dan, G. -A.; Boriani, G.; Lip, G. Y. H.
abstract

Background: Use of rate/rhythm control is essential to control symptoms in patients with atrial fibrillation (AF). Recently, the EAST-AFNET 4 trial described how early rhythm control strategy was associated with a lower risk of adverse clinical outcomes. Objectives: The aim was to evaluate the real-world applicability and impact of an early rhythm control strategy in patients with AF. Methods: Use of an early rhythm control strategy was assessed in a European cohort of AF patients derived from the EHRA-ESC EORP-AF General Long-Term Registry. Early rhythm control was defined as use of antiarrhythmic drugs or cardioversion/catheter ablation. The primary outcome included cardiovascular death, stroke, acute coronary syndrome, and worsening of heart failure. Quality of life and health-care resource usage were also assessed as outcomes. Results: Among the 10,707 patients evaluated for eligibility to EAST-AFNET 4, a total of 3774 (34.0%) were included. Early rhythm control was associated with better quality of life, but with greater use of health-care resources. During follow-up, the primary outcome occurred less often in early rhythm control patients than in those with no rhythm control (13.6% vs. 18.5%, p < 0.001). In the multivariate adjusted Cox regression model, no significant difference was found between no rhythm control and early rhythm control, for the primary outcome. No difference in the primary outcome between early rhythm control and ‘no rhythm control patients’ adherent to Atrial fibrillation Better Care (ABC) pathway’ was evident (p = 0.753) Conclusions: Use of an early rhythm control strategy was associated with a lower rate of major adverse events, but this difference was non-significant on multivariate analysis, being mediated by differences in baseline characteristics and clinical risk profile. Early rhythm control was associated with a higher use of health-care resources and risk of hospital admission, despite showing better quality of life. Graphic abstract: [Figure not available: see fulltext.]

2022 - Reimbursement practices for use of digital devices in atrial fibrillation and other arrhythmias: a European Heart Rhythm Association survey [Articolo su rivista]
Boriani, G.; Svennberg, E.; Guerra, F.; Linz, D.; Casado-Arroyo, R.; Malaczynska-Rajpold, K.; Duncker, D.; Boveda, S.; Merino, J. L.; Leclercq, C.
abstract

Since digital devices are increasingly used in cardiology for assessing cardiac rhythm and detecting arrhythmias, especially atrial fibrillation (AF), our aim was to evaluate the expectations and opinions of healthcare professionals in Europe on reimbursement policies for the use of digital devices (including wearables) in AF and other arrhythmias. An anonymous survey was proposed through announcements on the European Heart Rhythm Association website, social media channels, and mail newsletter. Two hundred and seventeen healthcare professionals participated in the survey: 32.7%, reported regular use of digital devices, 45.2% reported that they sometimes use these tools, 18.6% that they do not use but would like to. Only a minority (3.5%) reported a lack of trust in digital devices. The survey highlighted a general propensity to provide medical consultation for suspected AF or other arrhythmias detected by a consumer-initiated use of digital devices, even if time constraints and reimbursement availability emerged as important elements. More than 85% of respondents agreed that reimbursement should be applied for clinical use of digital devices, also in different settings such as post-stroke, post-cardioversion, post-ablation, and in patients with palpitations or syncope. Finally, 73.6% of respondents confirmed a lack of reimbursement fees in their country for physicians' consultations (tracings interpretation) related to digital devices. Digital devices, including wearables, are increasingly and widely used for assessing cardiac rhythm and detecting AF, but a definition of reimbursement policies for physicians' consultations is needed.

2022 - Rhythm- or rate-control strategies according to 4S-AF characterization scheme and long-term outcomes in atrial fibrillation patients: the FAMo (Fibrillazione Atriale in Modena) cohort [Articolo su rivista]
Malavasi, V. L.; Vitolo, M.; Colella, J.; Montagnolo, F.; Mantovani, M.; Proietti, M.; Potpara, T. S.; Lip, G. Y. H.; Boriani, G.
abstract

The 4S-AF scheme [Stroke risk, Symptom severity, Severity of atrial fibrillation (AF) burden, Substrate severity] was recently proposed to characterize AF patients. In this post hoc analysis we evaluated the agreement between the therapeutic strategy (rate or rhythm control, respectively), as suggested by the 4S-AF scheme, and the actual strategy followed in a patients cohort. Outcomes of interest were as follows: all-cause death, a composite of all-cause death/any thromboembolism/acute coronary syndrome, and a composite of all-cause death, any thrombotic/ischemic event, and major bleeding (net clinical outcome). We enrolled 615 patients: 60.5% male, median age 74 [interquartile range (IQR) 67–80] years; median CHA2DS2VASc 4 and median HAS-BLED 2. The 4S-AF score would have suggested a rhythm-control strategy in 351 (57.1%) patients while a rate control in 264 (42.9%). The strategy adopted was concordant with the 4S-AF suggestions in 342 (55.6%) cases, and non-concordant in 273 (44.4%). After a median follow-up of 941 days (IQR 365–1282), 113 (18.4%) patients died, 158 (25.7%) had an event of the composite endpoint. On adjusted Cox regression analysis, when 4S-AF score suggested rate control, disagreement with that suggestion was not associated with a worse outcome. When 4S-AF indicated rhythm control, disagreement was associated with a higher risk of all-cause death (HR 7.59; 95% CI 1.65–35.01), and of the composite outcome (HR 2.69; 95% CI 1.19–6.06). The 4S-AF scheme is a useful tool to comprehensively evaluate AF patients and aid the decision-making process. Disagreement with the rhythm control suggestion of the 4S-AF scheme was associated with adverse clinical outcomes.

2022 - Screening for Atrial Fibrillation in Relation to Stroke and Mortality Risk [Articolo su rivista]
Proietti, Marco; Boriani, Giuseppe
abstract

Not requested.

2022 - Screening for atrial fibrillation in the general population: experience from a cardiovascular risk campaign in the Emilia-Romagna Region|Screening della fibrillazione atriale nella popolazione generale: esperienza della campagna educazionale sul rischio cardiovascolare della Regione Emilia-Romagna [Articolo su rivista]
Di Pasquale, G.; Cardelli, L. S.; Canovi, L.; Dal Passo, B.; Frascaro, F.; Zanarelli, L.; Guardigli, G.; Campo, G.; Aschieri, D.; Vignali, L.; Navazio, A.; Rubboli, A.; Ortolani, P.; Galvani, M.; Ni, M.; Piovaccari, G.; Tortorici, G.; Urbinati, S.; Tondi, S.; Sassone, B.; Tortorella, G.; De Palma, R.; Casella, G.; Boriani, G.
abstract

Atrial fibrillation (AF) is a major cause of cerebral ischemia, and its early detection may impact on health. Both invasive and non-invasive devices can be used for the diagnosis of AF. The aim of our study was to estimate the prevalence of AF using a single-lead ECG device (MyDiagnostickTM) on an adult, asymptomatic population during a screening campaign.

2022 - Ten-year follow-up of cardiac resynchronization therapy patients with non-ischemic dilated cardiomyopathy assessed by radionuclide angiography: a single-center cohort study [Articolo su rivista]
Valzania, C.; Massaro, G.; Spadotto, A.; Muraglia, L.; Frisoni, J.; Martignani, C.; Ziacchi, M.; Diemberger, I.; Fanti, S.; Boriani, G.; Biffi, M.; Galie, N.
abstract

Purpose: Relatively few data are available on long-term survival and incidence of ventricular arrhythmias in cardiac resynchronization therapy (CRT) patients. We investigated long-term outcomes of CRT patients with non-ischemic dilated cardiomyopathy stratified as responders or non-responders according to radionuclide angiography. Methods: Fifty patients with non-ischemic dilated cardiomyopathy undergoing CRT were assessed by equilibrium Tc99 radionuclide angiography with bicycle exercise at baseline and after 3 months. Intra- and interventricular dyssynchrony were derived by Fourier phase analysis. Patient clinical outcome was assessed after 10 years. Results: At 3 months, 50% of patients were identified as CRT responders according to an increase in LV ejection fraction ≥ 5%. During a follow-up of 109 ± 48 months, 30% of patients died and 6% underwent heart transplantation. Age and history of paroxysmal atrial fibrillation were found to be predictors of all-cause mortality. CRT responders showed lower risk of death from cardiac causes than non-responders. At follow-up, 38% of patients presented at least one episode of sustained ventricular tachycardia, with a similar percentage between responders and non-responders. Conclusion: At long-term follow-up, non-ischemic CRT recipients identified as responders by radionuclide angiography were found to be at lower risk of worsening heart failure death than non-responders. Long-term risk for sustained ventricular arrhythmia was similar between CRT responders and non-responders.

2022 - The Interplay of PR Interval and AV Pacing Delays Used for Cardiac Resynchronization Therapy in Heart Failure Patients: Association with Clinical Response in a Retrospective Analysis of a Large Observational Study [Articolo su rivista]
Gasparini, Maurizio; Biffi, Mauro; Landolina, Maurizio; Cattafi, Giuseppe; Rordorf, Roberto; Botto, Giovanni Luca; Battista Forleo, Giovanni; Morani, Giovanni; Santini, Luca; Dello Russo, Antonio; Rossillo, Antonio; Meloni, Sarah; Grammatico, Andrea; Vitolo, Marco; Boriani, Giuseppe
abstract

Background. Cardiac resynchronization therapy (CRT) is a treatment for heart failure (HF) patients with prolonged QRS and impaired left ventricular (LV) systolic function. We aim to evaluate how the baseline PR interval is associated with outcomes (all-cause death or HF hospitalizations) and LV reverse remodeling (>15% relative reduction in LV end-systolic volume). Methods. Among 2224 patients with CRT defibrillators, 1718 (77.2%) had a device programmed at out-of-the-box settings (sensed AV delay: 100 ms and paced AV delay: 130 ms). Results. In this cohort of 1718 patients (78.7% men, mean age 66 years, 71.6% in NYHA class III/IV, LVEF = 27 +/- 6%), echocardiographic assessment at 6-month follow-up showed that LV reverse remodeling was not constant as a function of the PR interval; in detail, it occurred in 56.4% of all patients but was more frequent (76.6%) in patients with a PR interval of 160 ms. In a median follow-up of 20 months, the endpoint of death or HF hospitalizations occurred in 304/1718 (17.7%) patients; in the multivariable regression analysis it was significantly less frequent when the PR interval was between 150 and 170 ms (hazard ratio = 0.79, 95% confidence interval (CI): 0.63-0.99, p = 0.046). The same PR range was associated with higher probability of CRT response (odds ratio = 2.51, 95% CI: 1.41-4.47, p = 0.002). Conclusions. In a large population of CRT patients, with fixed AV pacing delays, specific PR intervals are associated with significant benefits in terms of LV reverse remodeling and lower morbidity. These observational data suggest the importance of optimizing pacing programming as a function of the PR interval to maximize CRT response and patient outcome.

2022 - The effect of cardiac resynchronization without a defibrillator on morbidity and mortality: insights from an individual patient data meta-analysis of COMPANION and CARE-HF [Articolo su rivista]
Leyva, F.; Boriani, G.
abstract

2022 - The impact of UEFA Euro 2020 football championship on Takotsubo Syndrome: Results of a multicenter national registry [Articolo su rivista]
Polimeni, A.; Spaccarotella, C.; Ielapi, J.; Esposito, G.; Ravera, A.; Martuscelli, E.; Ciconte, V.; Menichelli, M.; Varbella, F.; Imazio, M.; Navazio, A.; Sinagra, G.; Oberhollenzer, R.; Sibilio, G.; Cacciavillani, L.; Meloni, L.; Dominici, M.; Tomai, F.; Amico, F.; Corda, M.; Musumeci, G.; Lupi, A.; Zezza, L.; De Caterina, R.; Cernetti, C.; Metra, M.; Rossi, L.; Calabro, P.; Murrone, A.; Volpe, M.; Caldarola, P.; Carugo, S.; Cortese, B.; Valenti, R.; Boriani, G.; Fedele, F.; Ventura, G.; Manes, M. T.; Colavita, A. R.; Feola, M.; Versaci, F.; Assennato, P.; Arena, G.; Ceravolo, R.; Amodeo, V.; Tortorici, G.; Nassiacos, D.; Antonicelli, R.; Esposito, N.; Favale, S.; Licciardello, G.; Tedesco, L.; Indolfi, C.
abstract

Objectives: The UEFA 2020 European Football Championship held in multiple cities across Europe from June 11 to July 11, 2021, was won by Italy, providing an opportunity to examine the relationship between emotional stress and the incidence of acute cardiovascular events (ACE). Methods and results: Cardiovascular hospitalizations in the Cardiac Care Units of 49 hospital networks in Italy were assessed by emergency physicians during the UEFA Euro 2020 Football Championship. We compared the events that occurred during matches involving Italy with events that occurred during the remaining days of the championship as the control period. ACE was assessed in 1,235 patients. ACE during the UEFA Euro 2020 Football Championship semifinal and final, the most stressful matches ended with penalties and victory of the Italian team, were assessed. A significant increase in the incidence of Takotsubo Syndrome (TTS) by a factor of 11.41 (1.6–495.1, P < 0.003), as compared with the control period, was demonstrated during the semifinal and final, whereas no differences were found in the incidence of ACS [IRR 0.93(0.74–1.18), P = 0.57]. No differences in the incidence of ACS [IRR 0.98 (0.87–1.11; P = 0.80)] or TTS [IRR 1.66(0.80–3.4), P = 0.14] were found in the entire period including all matches of the UEFA Euro 2020 compared to the control period. Conclusions: The data of this national registry demonstrated an association between the semifinal and final of UEFA Euro 2020 and TTS suggesting that it can be triggered by also positive emotions such as the victory in the European Football Championship finals.

2022 - The search for a gold standard to clinically diagnose and monitor atrial cardiomyopathy [Articolo su rivista]
Boriani, G.; Vitolo, M.; Imberti, J. F.
abstract

Invited editorial commenting on:: Tufano A, Lancellotti P. "Atrial cardiomyopathy: Pathophysiology and clinical implications". Eur J Intern Med. 2022 Mar 11:S0953–6205(22)00097–8. doi: 10.1016/j.ejim.2022.03.007. Epub ahead of print. PMID: 35288030.

2022 - The value of wearable cardioverter defibrillator in adult patients with recent myocardial infarction: Economic and clinical implications from a health technology assessment perspective [Articolo su rivista]
Botto, G. L.; Mantovani, L. G.; Cortesi, P. A.; De Ponti, R.; D'Onofrio, A.; Biffi, M.; Capucci, A.; Casu, G.; Notarstefano, P.; Scaglione, M.; Zanotto, G.; Boriani, G.
abstract

Aims: Sudden cardiac death (SCD) causes high mortality and substantial societal burdens for healthcare systems (HSs). The risk of SCD is significantly increased in patients with reduced left ventricular ejection fraction after myocardial infarction (MI). Current guidelines recommend re-evaluation of cardioverter-defibrillator implantation 40 days post-MI, earliest. Medical therapy alone does not provide sufficient protection against SCD, especially in the first month post-MI, and needs time. Consequently, there is a gap in care of high-risk patients upon hospital discharge. The wearable cardioverter defibrillator (WCD) is a proven safe, effective therapy, which temporarily protects from SCD. Little information on WCD cost-effectiveness exists. We conducted this research to demonstrate the medical need of the device in the post-MI setting defining WCD cost-effectiveness. Methods & results: Based on a randomized clinical trials (RCTs) and Italian and international data, we developed a Markov-model comparing costs, patient survival, and quality-of-life, and calculated the Incremental Cost-Effectiveness Ratio (ICER) of a WCD vs. current standard of care in post-MI patients. The rather conservative base case analysis – based on the RCT intention-to-treat results - produced an ICER of €47,709 per Quality Adjusted Life Year (QALY) gained, which is far lower than the accepted threshold of €60,000 in the Italian National HS. The ICER per Life Year (LY) gained was €38,276. Conclusion: WCD utilization in post-MI patients is clinically beneficial and cost-effective. While improving guideline directed patient care, the WCD can also contribute to a more efficient use of resources in the Italian HS, and potentially other HSs as well.

2022 - Three-Dimensional Automated, Machine-Learning-Based Left Heart Chamber Metrics: Associations with Prevalent Vascular Risk Factors and Cardiovascular Diseases [Articolo su rivista]
Barbieri, A.; Albini, A.; Chiusolo, S.; Forzati, N.; Laus, V.; Maisano, A.; Muto, F.; Passiatore, M.; Stuani, M.; Torlai Triglia, L.; Vitolo, M.; Ziveri, V.; Boriani, G.
abstract

Background. Three-dimensional transthoracic echocardiography (3DE) powered by artificial intelligence provides accurate left chamber quantification in good accordance with cardiac magnetic resonance and has the potential to revolutionize our clinical practice. Aims. To evaluate the association and the independent value of dynamic heart model (DHM)-derived left atrial (LA) and left ventricular (LV) metrics with prevalent vascular risk factors (VRFs) and cardiovascular diseases (CVDs) in a large, unselected population. Materials and Methods. We estimated the association of DHM metrics with VRFs (hypertension, diabetes) and CVDs (atrial fibrillation, stroke, ischemic heart disease, cardiomyopathies, >moderate valvular heart disease/prosthesis), stratified by prevalent disease status: participants without VRFs or CVDs (healthy), with at least one VRFs but without CVDs, and with at least one CVDs. Results. We retrospectively included 1069 subjects (median age 62 [IQR 49–74]; 50.6% women). When comparing VRFs with the healthy, significant difference in maximum and minimum indexed atrial volume (LAVi max and LAVi min), left atrial ejection fraction (LAEF), left ventricular mass/left ventricular end-diastolic volume ratio, and left ventricular global function index (LVGFI) were recorded (p < 0.05). In the adjusted logistic regression, LAVi min, LAEF, LV ejection fraction, and LVGFI showed the most robust association (OR 3.03 [95% CI 2.48–3.70], 0.45 [95% CI 0.39–0.51], 0.28 [95% CI 0.22–0.35], and 0.22 [95% CI 0.16–0.28], respectively, with CVDs. Conclusions. The present data suggested that novel 3DE left heart chamber metrics by DHM such as LAEF, LAVi min, and LVGFI can refine our echocardiographic disease discrimination capacity.

2022 - Use of direct oral anticoagulants in patients with atrial fibrillation and obesity or low body weight: the additional contribution to knowledge provided by pharmacokinetic and pharmacodynamic studies [Articolo su rivista]
Boriani, G.
abstract

2022 - Vascular Accesses in Cardiac Stimulation and Electrophysiology: An Italian Survey Promoted by AIAC (Italian Association of Arrhythmias and Cardiac Pacing) [Articolo su rivista]
Ziacchi, M.; Placci, A.; Angeletti, D.; Quartieri, F.; Balla, C.; Virzi, S.; Bertini, M.; De Ponti, R.; Biffi, M.; Boriani, G.
abstract

Cardiac implantable electronic device (CIED) implants and electrophysiological procedures share a common step: Vascular access. On behalf of the AIAC Ricerca Investigators’ Network, we conducted a survey to outline Italian common practice regarding vascular access in EP-lab. All Italian physicians with experience in CIED implantation and electrophysiology were invited to answer an online questionnaire (from May 2020 to November 2020) featuring 20 questions. In total, 103 cardiologists (from 92 Italian hospitals) answered the survey. Vascular access during CIED implants was considered the most complex step following lead placement by 54 (52.4%) respondents and the most complex for 35 (33.9%). In total, 54 (52.4%) and 49 (47.6%) respondents considered the cephalic and subclavian vein the first option, respectively (intrathoracic and extrathoracic subclavian/axillary vein by 22 and 27, respectively). In total, 45 (43.7%) respondents performed close arterial femoral accesses manually; only 12 (11.7%) respondents made extensive use of vascular closure devices. A total of 46 out of 103 respondents had experience in ultrasound-guided vascular accesses, but only 10 (22%) used it for more than 50% of the accesses. In total, 81 (78.6%) respondents wanted to increase their ultrasound-guided vascular access skills. Reducing complications is a goal to reach in cardiac stimulation and electrophysiological procedures. Our survey shows the heterogeneity of the vascular approaches used in Italian centres. Some vascular accesses were proved to be superior to others in terms of complications, with ultrasound-guided puncture as an emerging technique. More effort to produce the standardization of vascular accesses could be made by scientific societies.

2022 - Ventricular and Atrial Remodeling after Transcatheter Edge-to-Edge Repair: A Pilot Study [Articolo su rivista]
Albini, Alessandro; Passiatore, Matteo; Imberti, Jacopo Francesco; Valenti, Anna Chiara; Leo, Giulio; Vitolo, Marco; Coppi, Francesca; Sgura, Fabio Alfredo; Boriani, Giuseppe
abstract

The aim of this study was to determine the impact of transcatheter edge-to-edge repair (TEER) on left and right ventricular (LV, RV) and left and right atrial (LA, RA) remodeling according to the mechanism of mitral regurgitation (MR) and history of atrial fibrillation (AF).

2021 - 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS) [Articolo su rivista]
Hindricks, Gerhard; Potpara, Tatjana; Dagres, Nikolaos; Arbelo, Elena; Bax, Jeroen J; Blomström-Lundqvist, Carina; Boriani, Giuseppe; Castella, Manuel; Dan, Gheorghe-Andrei; Dilaveris, Polychronis E; Fauchier, Laurent; Filippatos, Gerasimos; Kalman, Jonathan M; La Meir, Mark; Lane, Deirdre A; Lebeau, Jean-Pierre; Lettino, Maddalena; Lip, Gregory Y H; Pinto, Fausto J; Thomas, G Neil; Valgimigli, Marco; Van Gelder, Isabelle C; Van Putte, Bart P; Watkins, Caroline L; Kirchhof, Paulus; Kühne, Michael; Aboyans, Victor; Ahlsson, Anders; Balsam, Pawel; Bauersachs, Johann; Benussi, Stefano; Brandes, Axel; Braunschweig, Frieder; Camm, A John; Capodanno, Davide; Casadei, Barbara; Conen, David; Crijns, Harry J G M; Delgado, Victoria; Dobrev, Dobromir; Drexel, Heinz; Eckardt, Lars; Fitzsimons, Donna; Folliguet, Thierry; Gale, Chris P; Gorenek, Bulent; Haeusler, Karl Georg; Heidbuchel, Hein; Iung, Bernard; Katus, Hugo A; Kotecha, Dipak; Landmesser, Ulf; Leclercq, Christophe; Lewis, Basil S; Mascherbauer, Julia; Merino, Jose Luis; Merkely, Béla; Mont, Lluís; Mueller, Christian; Nagy, Klaudia V; Oldgren, Jonas; Pavlović, Nikola; Pedretti, Roberto F E; Petersen, Steffen E; Piccini, Jonathan P; Popescu, Bogdan A; Pürerfellner, Helmut; Richter, Dimitrios J; Roffi, Marco; Rubboli, Andrea; Scherr, Daniel; Schnabel, Renate B; Simpson, Iain A; Shlyakhto, Evgeny; Sinner, Moritz F; Steffel, Jan; Sousa-Uva, Miguel; Suwalski, Piotr; Svetlosak, Martin; Touyz, Rhian M; Dagres, Nikolaos; Arbelo, Elena; Bax, Jeroen J; Blomström-Lundqvist, Carina; Boriani, Giuseppe; Castella, Manuel; Dan, Gheorghe-Andrei; Dilaveris, Polychronis E; Fauchier, Laurent; Filippatos, Gerasimos; Kalman, Jonathan M; La Meir, Mark; Lane, Deirdre A; Lebeau, Jean-Pierre; Lettino, Maddalena; Lip, Gregory Y H; Pinto, Fausto J; Neil Thomas, G; Valgimigli, Marco; Van Gelder, Isabelle C; Watkins, Caroline L
abstract

2021 - 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS) [Articolo su rivista]
Hindricks, G.; Potpara, T.; Dagres, N.; Arbelo, E.; Bax, J. J.; Blomstrom-Lundqvist, C.; Boriani, G.; Castella, M.; Dan, G. -A.; Dilaveris, P. E.; Fauchier, L.; Filippatos, G.; Kalman, J. M.; La Meir, M.; Lane, D. A.; Lebeau, J. -P.; Lettino, M.; Lip, G. Y. H.; Pinto, F. J.; Neil Thomas, G.; Valgimigli, M.; Van Gelder, I. C.; Van Putte, B. P.; Watkins, C. L.
abstract

2021 - 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation, developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC), developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC [Articolo su rivista]
Hindricks, G.; Potpara, T.; Dagres, N.; Arbelo, E.; Bax, J. J.; Blomstrom-Lundqvist, C.; Boriani, G.; Castella, M.; Dan, G. -A.; Dilaveris, P. E.; Fauchier, L.; Filippatos, G.; Kalman, J. M.; Meir, M. L.; Lane, D. A.; Lebeau, J. -P.; Lettino, M.; Lip, G. Y. H.; Pinto, F. J.; Neil Thomas, G.; Valgimigli, M.; Van Gelder, I. C.; Van Putte, B. P.; Watkins, C. L.
abstract

2021 - 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy [Articolo su rivista]
Glikson, M.; Nielsen, J. C.; Kronborg, M. B.; Michowitz, Y.; Auricchio, A.; Barbash, I. M.; Barrabes, J. A.; Boriani, G.; Braunschweig, F.; Brignole, M.; Burri, H.; Coats, A. J. S.; Deharo, J. -C.; Delgado, V.; Diller, G. -P.; Israel, C. W.; Keren, A.; Knops, R. E.; Kotecha, D.; Leclercq, C.; Merkely, B.; Starck, C.; Thylen, I.; Tolosana, J. M.; Leyva, F.; Linde, C.; Abdelhamid, M.; Aboyans, V.; Arbelo, E.; Asteggiano, R.; Baron-Esquivias, G.; Bauersachs, J.; Biffi, M.; Birgersdotter-Green, U.; Bongiorni, M. G.; Borger, M. A.; Celutkiene, J.; Cikes, M.; Daubert, J. -C.; Drossart, I.; Ellenbogen, K.; Elliott, P. M.; Fabritz, L.; Falk, V.; Fauchier, L.; Fernandez-Aviles, F.; Foldager, D.; Gadler, F.; De Vinuesa, P. G. G.; Gorenek, B.; Guerra, J. M.; Hermann Haugaa, K.; Hendriks, J.; Kahan, T.; Katus, H. A.; Konradi, A.; Koskinas, K. C.; Law, H.; Lewis, B. S.; Linker, N. J.; Lochen, M. -L.; Lumens, J.; Mascherbauer, J.; Mullens, W.; Nagy, K. V.; Prescott, E.; Raatikainen, P.; Rakisheva, A.; Reichlin, T.; Ricci, R. P.; Shlyakhto, E.; Sitges, M.; Sousa-Uva, M.; Sutton, R.; Suwalski, P.; Svendsen, J. H.; Touyz, R. M.; Van Gelder, I. C.; Vernooy, K.; Waltenberger, J.; Whinnett, Z.; Witte, K. K.; Kronborg, M. B.; Michowitz, Y.; Auricchio, A.; Barbash, I. M.; Barrabes, J. A.; Qoriany, A.; Braunschweig, F.; Brignole, M.; Burri, H.; Coats, A. J. S.; Deharo, J. -C.; Delgado, V.; Diller, G. -P.; Israel, C. W.; Keren, A.; Knops, R. E.; Kotecha, D.; Leclercq, C.; Merkely, B.; Starck, C.; Thylen, I.; Tolosana, J. M.
abstract

2021 - 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation [Articolo su rivista]
Steffel, Jan; Collins, Ronan; Antz, Matthias; Cornu, Pieter; Desteghe, Lien; Haeusler, Karl Georg; Oldgren, Jonas; Reinecke, Holger; Roldan-Schilling, Vanessa; Rowell, Nigel; Sinnaeve, Peter; Vanassche, Thomas; Potpara, Tatjana; Camm, A John; Heidbüchel, Hein; Lip, Gregory Y H; Deneke, Thomas; Dagres, Nikolaos; Boriani, Giuseppe; Chao, Tze-Fan; Choi, Eue-Keun; Hills, Mellanie True; Santos, Itamar de Souza; Lane, Deirdre A; Atar, Dan; Joung, Boyoung; Cole, Oana Maria; Field, Mark
abstract

2021 - Anticoagulant selection in relation to the SAMe-TT2R2 score in patients with atrial fibrillation: The GLORIA-AF registry [Articolo su rivista]
Ntaios, G.; Huisman, M. V.; Diener, H. -C.; Halperin, J. L.; Teutsch, C.; Marler, S.; Gurusamy, V. K.; Thompson, M.; Lip, G. Y. H.; Olshansky, B.; Abban, D. W.; Abdul, N.; Abud, A. M.; Adams, F.; Addala, S.; Adragao, P.; Ageno, W.; Aggarwal, R.; Agosti, S.; Agostoni, P.; Aguilar, F.; Linares, J. A.; Aguinaga, L.; Ahmed, J.; Aiello, A.; Ainsworth, P.; Aiub, J. R.; Al-Dallow, R.; Alderson, L.; Aldrete Velasco, J. A.; Alexopoulos, D.; Manterola, F. A.; Aliyar, P.; Alonso, D.; Alves da Costa, F. A.; Amado, J.; Amara, W.; Amelot, M.; Amjadi, N.; Ammirati, F.; Andrade, M.; Andrawis, N.; Annoni, G.; Ansalone, G.; Ariani, M. K.; Arias, J. C.; Armero, S.; Arora, C.; Aslam, M. S.; Asselman, M.; Audouin, P.; Augenbraun, C.; Aydin, S.; Ayryanova, I.; Aziz, E.; Backes, L. M.; Badings, E.; Bagni, E.; Baker, S. H.; Bala, R.; Baldi, A.; Bando, S.; Banerjee, S.; Bank, A.; Esquivias, G. B.; Barr, C.; Bartlett, M.; Kes, V. B.; Baula, G.; Behrens, S.; Bell, A.; Benedetti, R.; Mazuecos, J. B.; Benhalima, B.; Bergler-Klein, J.; Berneau, J. -B.; Bernstein, R. A.; Berrospi, P.; Berti, S.; Berz, A.; Best, E.; Bettencourt, P.; Betzu, R.; Bhagwat, R.; Bhatta, L.; Biscione, F.; Bisignani, G.; Black, T.; Bloch, M. J.; Bloom, S.; Blumberg, E.; Bo, M.; Bohmer, E.; Bollmann, A.; Bongiorni, M. G.; Boriani, G.; Boswijk, D. J.; Bott, J.; Bottacchi, E.; Kalan, M. B.; Bradman, D.; Brautigam, D.; Breton, N.; Brouwers, P. J. A. M.; Browne, K.; Cortada, J. B.; Bruni, A.; Brunschwig, C.; Buathier, H.; Buhl, A.; Bullinga, J.; Cabrera, J. W.; Caccavo, A.; Cai, S.; Caine, S.; Calo, L.; Calvi, V.; Sanchez, M. C.; Candeias, R.; Capuano, V.; Capucci, A.; Caputo, R.; Rizo, T. C.; Cardona, F.; Carlos da Costa Darrieux, F.; Duarte Vera, Y. C.; Carolei, A.; Carreno, S.; Carvalho, P.; Cary, S.; Casu, G.; Cavallini, C.; Cayla, G.; Celentano, A.; Cha, T. -J.; Cha, K. S.; Chae, J. K.; Chalamidas, K.; Challappa, K.; Chand, S. P.; Chandrashekar, H.; Chartier, L.; Chatterjee, K.; Chavez Ayala, C. A.; Cheema, A.; Cheema, A.; Chen, L.; Chen, S. -A.; Chen, J. H.; Chiang, F. -T.; Chiarella, F.; Chih-Chan, L.; Cho, Y. K.; Choi, J. -I.; Choi, D. J.; Chouinard, G.; Hoi-Fan Chow, D.; Chrysos, D.; Chumakova, G.; Jose Roberto Chuquiure Valenzuela, E. J.; Nica, N. C.; Cislowski, D. J.; Clay, A.; Clifford, P.; Cohen, A.; Cohen, M.; Cohen, S.; Colivicchi, F.; Collins, R.; Colonna, P.; Compton, S.; Connolly, D.; Conti, A.; Buenostro, G. C.; Coodley, G.; Cooper, M.; Coronel, J.; Corso, G.; Sales, J. C.; Cottin, Y.; Covalesky, J.; Cracan, A.; Crea, F.; Crean, P.; Crenshaw, J.; Cullen, T.; Darius, H.; Dary, P.; Dascotte, O.; Dauber, I.; Davalos, V.; Davies, R.; Davis, G.; Davy, J. -M.; Dayer, M.; De Biasio, M.; De Bonis, S.; De Caterina, R.; De Franceschi, T.; de Groot, J. R.; De Horta, J.; De La Briolle, A.; Topete, G. D. L. P.; Vicenzo de Paola, A. A.; de Souza, W.; de Veer, A.; De Wolf, L.; Decoulx, E.; Deepak, S.; Defaye, P.; Del-Carpio Munoz, F.; Brkljacic, D. D.; Deumite, N. J.; Di Legge, S.; Diemberger, I.; Dietz, D.; Dionisio, P.; Dong, Q.; Rossi dos Santos, F.; Dotcheva, E.; Doukky, R.; D'Souza, A.; Dubrey, S.; Ducrocq, X.; Dupljakov, D.; Duque, M.; Dutta, D.; Duvilla, N.; Duygun, A.; Dziewas, R.; Eaton, C. B.; Eaves, W.; Ebels-Tuinbeek, L. A.; Ehrlich, C.; Eichinger-Hasenauer, S.; Eisenberg, S. J.; El Jabali, A.; El Shahawy, M.; Hernandes, M. E.; Izal, A. E.; Evonich, R.; Evseeva, O.; Ezhov, A.; Fahmy, R.; Fang, Q.; Farsad, R.; Fauchier, L.; Favale, S.; Fayard, M.; Fedele, J. L.; Fedele, F.; Fedorishina, O.; Fera, S. R.; Gomes Ferreira, L. G.; Ferreira, J.; Ferri, C.; Ferrier, A.; Ferro, H.; Finsen, A.; First, B.; Fischer, S.; Fonseca, C.; Almeida, L. F.; Forman, S.; Frandsen, B.; French, W.; Friedman, K.; Friese, A.; Fruntelata, A. G.; Fujii, S.; Fumagalli, S.; Fundamenski, M.; Furukawa, Y.; Gabelmann, M.; Gabra, N.; Gadsboll, N.; Galinier, M.; Gammelgaard, A.; Ganeshkumar, P.; Gans, C.; Quintana, A. G.; Gartenlaub, O.; Gaspardone, A.; Genz, C.; Georger, F.; Georges, J. -L.; Georgeson, S.;
abstract

Aim: The SAMe-TT2R2 score helps identify patients with atrial fibrillation (AF) likely to have poor anticoagulation control during anticoagulation with vitamin K antagonists (VKA) and those with scores >2 might be better managed with a target-specific oral anticoagulant (NOAC). We hypothesized that in clinical practice, VKAs may be prescribed less frequently to patients with AF and SAMe-TT2R2 scores >2 than to patients with lower scores. Methods and results: We analyzed the Phase III dataset of the Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF), a large, global, prospective global registry of patients with newly diagnosed AF and ≥1 stroke risk factor. We compared baseline clinical characteristics and antithrombotic prescriptions to determine the probability of the VKA prescription among anticoagulated patients with the baseline SAMe-TT2R2 score >2 and ≤ 2. Among 17,465 anticoagulated patients with AF, 4,828 (27.6%) patients were prescribed VKA and 12,637 (72.4%) patients an NOAC: 11,884 (68.0%) patients had SAMe-TT2R2 scores 0-2 and 5,581 (32.0%) patients had scores >2. The proportion of patients prescribed VKA was 28.0% among patients with SAMe-TT2R2 scores >2 and 27.5% in those with scores ≤2. Conclusions: The lack of a clear association between the SAMe-TT2R2 score and anticoagulant selection may be attributed to the relative efficacy and safety profiles between NOACs and VKAs as well as to the absence of trial evidence that an SAMe-TT2R2-guided strategy for the selection of the type of anticoagulation in NVAF patients has an impact on clinical outcomes of efficacy and safety. The latter hypothesis is currently being tested in a randomized controlled trial. Clinical trial registration: URL: https://www.clinicaltrials.gov//Unique identifier: NCT01937377, NCT01468701, and NCT01671007.

2021 - Anticoagulation in patients with atrial fibrillation and active cancer: an international survey on patient management [Articolo su rivista]
Boriani, G.; Lee, G.; Parrini, I.; Lopez-Fernandez, T.; Lyon, A. R.; Suter, T.; Van der Meer, P.; Cardinale, D.; Lancellotti, P.; Zamorano, J. L.; Bax, J. J.; Asteggiano, R.
abstract

BACKGROUND: In patients with active cancer and atrial fibrillation (AF) anticoagulation, thrombotic and bleeding risk still entail uncertainty. AIM: We explored the results of an international survey examining the knowledge and behaviours of a large group of physicians. METHODS AND RESULTS: A web-based survey was completed by 960 physicians (82.4% cardiologists, 75.5% from Europe). Among the currently available anticoagulants for stroke prevention in patients with active cancer, direct oral anticoagulants (DOACs) were preferred by 62.6%, with lower values for low molecular weight heparin (LMWH) (24.1%) and for warfarin (only 7.3%). About 46% of respondents considered that DOACs should be used in all types of cancers except in non-operable gastrointestinal cancers. The lack of controlled studies on bleeding risk (33.5% of respondents) and the risk of drug interactions (31.5%) were perceived as problematic issues associated with use of anticoagulants in cancer. The decision on anticoagulation involved a cardiologist in 27.8% of cases, a cardiologist and an oncologist in 41.1%, and a team approach in 21.6%. The patient also was involved in decision-making, according to ∼60% of the respondents. For risk stratification, use of CHA2DS2-VASc and HAS-BLED scores was considered appropriate, although not specifically validated in cancer patients, by 66.7% and 56.4%, respectively. CONCLUSION: This survey highlights that management of anticoagulation in patients with AF and active cancer is challenging, with substantial heterogeneity in therapeutic choices. Direct oral anticoagulants seems having an emerging role but still the use of LMWH remains substantial, despite the absence of long-term data on thromboprophylaxis in AF.

2021 - Atrial fibrillation in dilated cardiomyopathy: Outcome prediction from an observational registry [Articolo su rivista]
Nuzzi, V.; Cannata, A.; Manca, P.; Castrichini, M.; Barbati, G.; Aleksova, A.; Fabris, E.; Zecchin, M.; Merlo, M.; Boriani, G.; Sinagra, G.
abstract

Background: Little is known about the role of different types of atrial fibrillation (AF) in dilated cardiomyopathy (DCM). We investigated the epidemiological and prognostic impact of different types of AF in DCM during long-term follow-up. Method: We evaluated consecutive DCM patients enrolled in the Trieste Muscle Heart Disease Registry. Uni- and multivariable, extended Kaplan-Meier and propensity score-matching analyses were performed for a composite outcome including death/heart transplantation/ventricular-assist device implantation. Results: Out of 1181 DCM patients (71% males, age 49 ± 15 years, left ventricular ejection fraction 33 ± 11%), 46 (3.9%) had baseline permanent AF (permAF), while 66 (5.6%) had a history of paroxysmal/persistent AF. Compared with sinus rhythm (SR) patients, permAF patients were older (48 ± 15 vs. 61 ± 11 respectively, p = 0.001), were more frequently in NYHA class III-IV (18% vs. 30%, p = 0.002) and had larger left atrium diameter (40 ± 8 vs. 50 ± 10 mm, respectively). Paroxysmal/persistent AF patients had intermediate characteristics between permAF and SR. During a median follow-up of 135 (75–210) months, 63 patients developed permAF (0.45 new cases/100patients/year). At multivariable analysis, permAF as a time-dependent variable was an independent outcome predictor (HR 2.45; 95% C.I. 2.61–3.63, p < 0.001), together with creatinine, NYHA class, restrictive filling pattern and moderate-severe mitral regurgitation, while paroxysmal/persistent AF was neutral. Propensity score-matching analysis confirmed the higher rate of primary outcome events in patients with baseline or incident permAF versus patients without permAF during a very long-term follow-up (70% vs. 20%, p < 0.001). Conclusions: PermAF in a large DCM cohort had low prevalence and incidence but had a relevant. prognostic role on hard outcomes.

2021 - Atrial fibrillation is related to higher mortality in COVID-19/SARS-CoV-2 pneumonia infection [Articolo su rivista]
Denegri, Andrea; Morelli, Marianna; Pezzuto, Giuseppe; Malavasi, Vincenzo Livio; Boriani, Giuseppe
abstract

2021 - Atrial fibrillation pattern and factors affecting the progression to permanent atrial fibrillation [Articolo su rivista]
Malavasi, V. L.; Fantecchi, E.; Tordoni, V.; Melara, L.; Barbieri, A.; Vitolo, M.; Lip, G. Y. H.; Boriani, G.
abstract

Atrial fibrillation (AF) may progress from a non-permanent to a permanent form, and improvement in prediction may help in decision-making. In- and outpatients with non-permanent AF were enrolled in a prospective study and followed every 6 months. At baseline, 314 out of 523 patients (60%) had non-permanent AF (25.5% paroxysmal AF, 52.5% persistent, 2% first diagnosed AF). They were mostly males (188, 59.9%), median age 71 years [interquartile range (IQ) 62–77], median CHA2DS2VASc 3 (IQ 1–4), median HATCH score 1 (IQ 1–2). During a follow-up of 701 (IQ 437–902) days, 66 patients (21%) developed permanent AF. CHA2DS2VASc and HATCH scores were incrementally associated with AF progression (p for trend CHA2DS2VASc < 0.001, HATCH p = 0.001). Cox multivariable proportional hazard regression analysis showed that age [hazard ratio (HR) 1.042; 95%CI 1.005–1.080; p = 0.025], moderate–severe left atrial (LA) enlargement at echo (HR 2.072, 95%CI, 1.121–3.831; p = 0.020), antiarrhythmics drugs (HR 0.087, 95%CI 0.011–0.659, p = 0.018), EHRA score > 2 (HR 0.358, 95%CI 0.162–0.791, p = 0.011) and valvular disease (HR 2.196, 95%CI 1.072–4.499, p = 0.032) were significantly associated with AF progression. Adding “moderate–severe LA dilation” to clinical scores, eg. HATCH score (HATCH-LA) with 2 points (Cox multivariable regression analysis) improved prediction of AF progression vs. HATCH score (p = 0.0225). In patients without permanent AF, progression of AF was independently associated with age, LA dilation, AF symptoms severity, antiarrhythmic drugs and valvular disease. Adding LA dilation (moderate–severe volume increase) to clinical scores improved prediction of progression to permanent AF.

2021 - Beyond the 2020 guidelines on atrial fibrillation of the European society of cardiology [Articolo su rivista]
Boriani, G.; Vitolo, M.; Lane, D. A.; Potpara, T. S.; Lip, G. Y.
abstract

The most recent atrial fibrillation (AF) guidelines delivered by European Society of Cardiology (ESC) offer an updated approach to AF management, with the perspective of improved characterization of the arrhythmia, the cardiac substrate and the patients profile in terms of associated risk factors and comorbidities. Recommendations were based on careful scrutiny and assessment of all available evidence with the final aim to offer to practitioners a lower level of uncertainty in the complex process of decision making for patients with AF. The 2020 ESC guidelines on AF propose a paradigm shift in the clinical approach to AF patients, moving from a single-domain AF classification to comprehensive characterization of AF patients. Given the complex nature of AF, an integrated holistic management of AF patients is suggested by the guidelines for improving patients outcomes through the formal introduction of the CC (Confirm AF and Characterize AF) to ABC (Atrial fibrillation Better Care) pathway. In line with this concept, these new guidelines underline the importance of a more comprehensive management of AF patients which should not be limited to simply prescribe oral anticoagulation or decide between a rhythm or rate control strategy. Indeed, each step of the ABC pathway represents one of the pivotal pillars in the management of AF and only a holistic approach has the potential to improve patients’ outcomes. In this review we will discuss the background that supports some of the new recommendations of 2020 ESC guidelines, with important implications for daily management of AF patients.

2021 - Biomarkers in atrial fibrillation: A constant search for simplicity, practicality, and cost-effectiveness [Articolo su rivista]
Boriani, G.; Valenti, A. C.; Vitolo, M.
abstract

2021 - COVID-19 pandemic: complex interactions with the arrhythmic profile and the clinical course of patients with cardiovascular disease [Articolo su rivista]
Boriani, Giuseppe; Vitolo, Marco
abstract

2021 - Cardiac resynchronization therapy: variations across Europe in implant rates and types of implanted devices [Articolo su rivista]
Boriani, G.; Imberti, J. F.; Bonini, N.; Vitolo, M.
abstract

2021 - Catheter ablation as first-line treatment for paroxysmal atrial fibrillation: A systematic review and meta-analysis [Articolo su rivista]
Imberti, J. F.; Ding, W. Y.; Kotalczyk, A.; Zhang, J.; Boriani, G.; Lip, G.; Andrade, J.; Gupta, D.
abstract

Objective: To assess the efficacy and safety of catheter ablation (CA) compared with antiarrhythmic drugs (AADs) as first-line treatment for symptomatic paroxysmal atrial fibrillation (AF). Methods: Systematic review and meta-analysis of randomised controlled trials identified using MEDLINE, Cochrane Library and Embase published between 01/01/2000 and 19/03/2021. The primary efficacy endpoint was the first documented recurrence of atrial arrhythmias following the blanking period. The primary safety endpoint was a composite of all serious adverse events (SAEs). Results: From 441 records, 6 studies met the inclusion criteria. 609 patients received CA, while 603 received AAD therapy. 212/609 patients in the CA group had a recurrence of atrial arrhythmias as compared with 318/603 in the AADs group resulting in a 36% relative risk reduction (risk ratio: 0.64, 95% CI 0.51 to 0.80, p<0.01). The risk of all SAEs was not statistically different between CA and AAD (0.87, 0.58 to 1.30, p=0.49); 107/609 SAE in the CA group vs 126/603 in the AAD group. Both recurrence of symptomatic atrial arrhythmias (109/505 vs 186/504) and healthcare utilisation (126/397 vs 185/394) were significantly lower in the CA group (0.53, 0.35 to 0.79 and 0.65, 0.48 to 0.89, respectively). There was a 79% reduction in the crossover rate during follow-up among patients randomised to CA compared with AAD (0.21, 0.13 to 0.32, p<0.01). Conclusions: First-line treatment with CA is superior to AAD therapy in patients with symptomatic paroxysmal AF, as it significantly reduces the recurrence of any atrial arrhythmias and symptomatic atrial arrhythmias, and healthcare resource utilisation with comparable safety profile.

2021 - Characterization of atrial fibrillation in real-world patients: testing the 4S-AF scheme in the Spanish and French cohorts of the EORP-AF Long-Term General Registry [Articolo su rivista]
Rivera-Caravaca, José Miguel; Piot, Olivier; Roldán-Rabadán, Inmaculada; Denis, Arnaud; Anguita, Manuel; Mansourati, Jacques; Pérez-Cabeza, Alejandro; Marijon, Eloi; García-Seara, Javier; Leclercq, Christophe; García-Bolao, Ignacio; Lellouche, Nicolas; Potpara, Tatjana; Boriani, Giuseppe; Fauchier, Laurent; Lip, Gregory Y H; Marín, Francisco
abstract

The 4S-AF scheme [Stroke risk, Symptom severity, Severity of atrial fibrillation (AF) burden, Substrate severity] has recently been described as a novel approach to in-depth characterization of AF. We aim to determine if the 4S-AF scheme would be useful for AF characterization and provides prognostic information in real-world AF patients.

2021 - Clinical Factors Associated with Atrial Fibrillation Detection on Single-Time Point Screening Using a Hand-Held Single-Lead ECG Device [Articolo su rivista]
Boriani, Giuseppe; Palmisano, Pietro; Malavasi, Vincenzo Livio; Fantecchi, Elisa; Vitolo, Marco; Bonini, Niccolo’; Imberti, Jacopo F.; Valenti, Anna Chiara; Schnabel, Renate B.; Freedman, Ben
abstract

Our aim was to assess the prevalence of unknown atrial fibrillation (AF) among adults during single-time point rhythm screening performed during meetings or social recreational activities organized by patient groups or volunteers. A total of 2814 subjects (median age 68 years) underwent AF screening by a handheld single-lead ECG device (MyDiagnostick). Overall, 56 subjects (2.0%) were diagnosed with AF, as a result of 12-lead ECG following a positive/suspected recording. Screening identified AF in 2.9% of the subjects >= 65 years. None of the 265 subjects aged below 50 years was found positive at AF screening. Risk stratification for unknown AF based on a CHA(2)DS(2)VASc > 0 in males and >1 in females (or CHA(2)DS(2)VA > 0) had a high sensitivity (98.2%) and a high negative predictive value (99.8%) for AF detection. A slightly lower sensitivity (96.4%) was achieved by using age >= 65 years as a risk stratifier. Conversely, raising the threshold at >= 75 years showed a low sensitivity. Within the subset of subjects aged >= 65 a CHA(2)DS(2)VASc > 1 in males and >2 in females, or a CHA(2)DS(2)VA > 1 had a high sensitivity (94.4%) and negative predictive value (99.3%), while age >= 75 was associated with a marked drop in sensitivity for AF detection.

2021 - Clinical Value of Complex Echocardiographic Left Ventricular Hypertrophy Classification Based on Concentricity, Mass, and Volume Quantification [Articolo su rivista]
Barbieri, Andrea; Albini, Alessandro; Maisano, Anna; De Mitri, Gerardo; Camaioni, Giovanni; Bonini, Niccolò; Mantovani, Francesca; Boriani, Giuseppe
abstract

Echocardiography is the most validated, non-invasive and used approach to assess left ventricular hypertrophy (LVH). Alternative methods, specifically magnetic resonance imaging, provide high cost and practical challenges in large scale clinical application. To include a wide range of physiological and pathological conditions, LVH should be considered in conjunction with the LV remodeling assessment. The universally known 2-group classification of LVH only considers the estimation of LV mass and relative wall thickness (RWT) to be classifying variables. However, knowledge of the 2-group patterns provides particularly limited incremental prognostic information beyond LVH. Conversely, LV enlargement conveys independent prognostic utility beyond LV mass for incident heart failure. Therefore, a 4-group LVH subdivision based on LV mass, LV volume, and RWT has been recently suggested. This novel LVH classification is characterized by distinct differences in cardiac function, allowing clinicians to distinguish between different LV hemodynamic stress adaptations in various cardiovascular diseases. The new 4-group LVH classification has the advantage of optimizing the LVH diagnostic approach and the potential to improve the identification of maladaptive responses that warrant targeted therapy. In this review, we summarize the current knowledge on clinical value of this refinement of the LVH classification, emphasizing the role of echocardiography in applying contemporary proposed indexation methods and partition values.

2021 - Clinical and electrocardiographic characteristics at admission of COVID-19/SARS-CoV2 pneumonia infection [Articolo su rivista]
Denegri, A.; Pezzuto, G.; D'Arienzo, M.; Morelli, M.; Savorani, F.; Cappello, C. G.; Luciani, A.; Boriani, G.
abstract

Background: The aim of the present study was to compare clinical and electrocardiographic characteristics of patients with COVID-19 pneumonia in Modena, Emilia Romagna, Italy. Methods: Patients admitted to the emergency department for suspected COVID-19 pneumonia from March the 16th to April the 15th were enrolled in the study. COVID-19 pneumonia was confirmed by positive nasopharyngeal swab. Primary endpoint was 30-day mortality. Results: 201 patients were diagnosed with COVID-19 pneumonia. Compared to survivors, patients who died were older (79.7 ± 10.8 vs 65.6 ± 14.1, p < 0.001), with a more complex cardiovascular history, including coronary artery disease (CAD, 33.3% vs 13.3%, p = 0.004), atrial fibrillation (23.8 vs 8.8, p = 0.011) and chronic kidney disease (CKD 35.7% vs 7.0%, p < 0.001). 30-day mortality was 20,9% in these patients; atrial fibrillation (OR 12.74, 95% CI 3.65–44.48, p < 0.001), ST-segment depression (OR 5.30, 95% CI 1.50–18.81, p = 0.010) and QTc-interval prolongation (OR 3.17, 95% CI 1.24–8.10, p = 0.016) at ECG admission were associated to an increased mortality risk. On the contrary, sinus rhythm (OR 0.08, 95% CI 0.02–0.27, p < 0.001) and low-molecular weight heparin (LMWH) administration (OR 0.08, 95% CI 0.02–0.29, p < 0.001) were related to reduced mortality. At multivariate analysis, after adjustment for age, sex, diabetes, CAD, and MCA admission, sinus rhythm (HR 2.7, CI 95% 1.1–7.0, p = 0.038) and LMWH (HR 8.5, 95% CI 2.0–36.6, p = 0.004) were confirmed to be independent predictors of increased survival. Conclusion: Sinus rhythm at ECG admission in COVID-19 pneumonia patients was associated with greater survival as well as LMWH administration, which conferred an overall better outcome.

2021 - Clinical management of electrical storm: a current overview [Articolo su rivista]
Guarracini, Fabrizio; Casella, Michela; Muser, Daniele; Barbato, Gaetano; Notarstefano, Pasquale; Sgarito, Giuseppe; Marini, Massimiliano; Grandinetti, Giuseppe; Mariani, Marco V.; Boriani, Giuseppe; Ricci, Renato P.; De Ponti, Roberto; Lavalle, Carlo
abstract

The number of patients affected by electrical storm has been continuously increasing in emergency departments. Patients are often affected by multiple comorbidities requiring multidisciplinary interventions to achieve a clinical stability. Careful reprogramming of cardiac devices, correction of electrolyte imbalance, knowledge of underlying heart disease and antiarrhythmic drugs in the acute phase play a crucial role. The aim of this review is to provide a comprehensive overview of pharmacological treatment, latest transcatheter ablation techniques and advanced management of patients with electrical storm.

2021 - Clinical phenotype classification of atrial fibrillation patients using cluster analysis and associations with trial-adjudicated outcomes [Articolo su rivista]
Vitolo, M.; Proietti, M.; Shantsila, A.; Boriani, G.; Lip, G. Y. H.
abstract

Background and purpose: Given the great clinical heterogeneity of atrial fibrillation (AF) patients, conventional classification only based on disease subtype or arrhythmia patterns may not adequately characterize this population. We aimed to identify different groups of AF patients who shared common clinical phenotypes using cluster analysis and evaluate the association between identified clusters and clinical outcomes. Methods: We performed a hierarchical cluster analysis in AF patients from AMADEUS and BOREALIS trials. The primary outcome was a composite of stroke/thromboembolism (TE), cardiovascular (CV) death, myocardial infarction, and/or all-cause death. Individual components of the primary outcome and major bleeding were also assessed. Results: We included 3980 AF patients treated with the Vitamin-K Antagonist from the AMADEUS and BOREALIS studies. The analysis identified four clusters in which patients varied significantly among clinical characteristics. Cluster 1 was characterized by patients with low rates of CV risk factors and comorbidities; Cluster 2 was characterized by patients with a high burden of CV risk factors; Cluster 3 consisted of patients with a high burden of CV comorbidities; Cluster 4 was characterized by the highest rates of non-CV comorbidities. After a mean follow-up of 365 (standard deviation 187) days, Cluster 4 had the highest cumulative risk of outcomes. Compared with Cluster 1, Cluster 4 was independently associated with an increased risk for the composite outcome (hazard ratio (HR) 2.43, 95% confidence interval (CI) 1.70–3.46), all-cause death (HR 2.35, 95% CI 1.58–3.49) and major bleeding (HR 2.18, 95% CI 1.19–3.96). Conclusions: Cluster analysis identified four different clinically relevant phenotypes of AF patients that had unique clinical characteristics and different outcomes. Cluster analysis highlights the high degree of heterogeneity in patients with AF, suggesting the need for a phenotype-driven approach to comorbidities, which could provide a more holistic approach to management aimed to improve patients’ outcomes.

2021 - Cognitive impairment in patients with atrial fibrillation: Implications for outcome in a cohort study [Articolo su rivista]
Malavasi, Vincenzo Livio; Zoccali, Cristina; Brandi, Maria Chiara; Micali, Giulia; Vitolo, Marco; Imberti, Jacopo Francesco; Mussi, Chiara; Schnabel, Renate B; Freedman, Ben; Boriani, Giuseppe
abstract

The impact of cognitive status on outcomes of patients with atrial fibrillation (AF) is not well defined.

2021 - Cohort profile The ESC EURObservational Research Programme Atrial Fibrillation III (AF III) Registry [Articolo su rivista]
Potpara, Tatjana S; Lip, Gregory Y H; Dagres, Nikolaos; Crijns, Harry J M G; Boriani, Giuseppe; Kirchhof, Paulus; Arbelo, Elena; Savelieva, Irina; Lenarczyk, Radoslaw; Fauchier, Laurent; Maggioni, Aldo P; Gale, Chris P
abstract

The European Society of Cardiology (ESC) EURObservational Research Programme (EORP)-Atrial Fibrillation (AF) III Registry aims to identify contemporary patterns in AF management in clinical practice, assess their compliance with the 2016 ESC AF Guidelines, identify major gaps in guideline implementation, characterize the clinical practice settings associated with good versus poor guideline implementation and assess and compare the 1-year outcome of guideline-adherent versus guideline non-adherent management strategies.

2021 - Comparing outcomes in asymptomatic and symptomatic atrial fibrillation: A systematic review and meta-analysis of 81,462 patients [Articolo su rivista]
Sgreccia, D.; Manicardi, M.; Malavasi, V. L.; Vitolo, M.; Valenti, A. C.; Proietti, M.; Lip, G. Y. H.; Boriani, G.
abstract

Background: In atrial fibrillation (AF) patients, the presence of symptoms can guide the decision between rate or rhythm control therapy, but it is still unclear if AF-related outcomes are determined by symptomatic status of their clinical presentation. Methods: We performed a systematic review and metanalysis following the PRISMA recommendations on available studies that compared asymptomatic to symptomatic AF reporting data on all-cause mortality, cardiovascular death, and thromboembolic events (TEs). We included studies with a total number of patients enrolled equal to or greater than 200, with a minimum follow-up period of six months. Results: From the initial 5476 results retrieved after duplicates’ removal, a total of 10 studies were selected. Overall, 81,462 patients were included, of which 21,007 (26%) were asymptomatic, while 60,455 (74%) were symptomatic. No differences were found between symptomatic and asymptomatic patients regarding the risks of all-cause death (odds ratio (OR) 1.03, 95% confidence interval (CI) 0.81–1.32), and cardiovascular death (OR 0.87, 95% CI 0.54–1.39). No differences between symptomatic and asymptomatic groups were evident for stroke (OR 1.22, 95% CI 0.77–1.93) and stroke/TE (OR 1.06, 95% CI 0.86–1.31) risks. Conclusions: Mortality and stroke/TE events in AF patients were unrelated to symptomatic status of their clinical presentation. Adoption of management strategies in AF patients should not be based on symptomatic clinical status.

2021 - Comparison of HAS-BLED and ORBIT Bleeding Risk Scores in AF Patients treated with NOACs: A Report from the ESC-EHRA EORP-AF General Long-Term Registry [Articolo su rivista]
Proietti, Marco; Romiti, Giulio Francesco; Vitolo, Marco; Potpara, Tatjana S; Boriani, Giuseppe; Lip, Gregory Y H
abstract

Introduction: Bleeding risk assessment is recommended in guidelines for the management of atrial fibrillation (AF). HAS-BLED score was proposed prior to non-vitamin K antagonist oral anticoagulants (NOACs) and has been suggested that the ORBIT score may be superior in predicting bleeds in NOAC users. We aimed to compare the HAS-BLED and ORBIT scores in contemporary AF patients treated with NOACs. Methods and results: We analyzed patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry. HAS-BLED and ORBIT scores were computed based on original schemes. The primary outcome was the occurrence of Major Bleeding (MB). A total of 3018 patients (median age 70; 39.6% females) were included: median [IQR] HAS-BLED and ORBIT scores were 1 [1-2] and 1 [0-2], respectively; 356 (11.8%) patients were at high risk for MB using HAS-BLED (≥3) and 123 (4.1%) using ORBIT (≥4). Overall, 60 (2.0%) MB events were recorded, with an incidence of 1.1 per 100 patient-years.Both HAS-BLED and ORBIT were associated with outcome, modestly predicting MB (AUC 0.653, 95% CI 0.593-0.714 and AUC 0.601, 95% CI 0.526-0.677, respectively). Calibration plots showed that both scores were poorly calibrated, particularly the ORBIT score, which showed consistent poorer calibration. Time-dependent reclassification analysis showed a trend towards incorrect lower risk reclassification using ORBIT compared to HAS-BLED. Conclusion: In this real-life contemporary cohort of AF patients treated with NOACs, the ORBIT score did not provide reclassification improvement, showing even poorer calibration compared to HAS-BLED. Our findings do not support the preferential use of ORBIT in NOAC-treated AF patients.

2021 - Contemporary management of patients with atrial fibrillation in the Netherlands and Belgium: a report from the EORP-AF long-term general registry [Articolo su rivista]
Erkuner, O.; van Eck, M.; Xhaet, O.; Verheij, H.; Neefs, J.; Duygun, A.; Nijmeijer, R.; Said, S. A. M.; Uiterwaal, H.; Hagens, V.; Bhagwandien, R.; Szili-Torok, T.; Bijsterveld, N.; Tjeerdsma, G.; Vijgen, J.; Friart, A.; Hoffer, E.; Evrard, P.; Srynger, M.; Meeder, J.; de Groot, J. R.; van Opstal, J.; Gevers, R.; Lip, G. Y. H.; Boriani, G.; Crijns, H. J. G. M.; Luermans, J. G. L. M.; Mairesse, G. H.
abstract

Background: Contemporary data regarding the characteristics, treatment and outcomes of patients with atrial fibrillation (AF) are needed. We aimed to assess these data and guideline adherence in the EURObservational Research Programme on Atrial Fibrillation (EORP-AF) long-term general registry. Methods: We analysed 967 patients from the EORP-AF long-term general registry included in the Netherlands and Belgium from 2013 to 2016. Baseline and 1‑year follow-up data were gathered. Results: At baseline, 887 patients (92%) received anticoagulant treatment. In 88 (10%) of these patients, no indication for chronic anticoagulant treatment was present. A rhythm intervention was performed or planned in 52 of these patients, meaning that the remaining 36 (41%) were anticoagulated without indication. Forty patients were not anticoagulated, even though they had an indication for chronic anticoagulation. Additionally, 63 of the 371 patients (17%) treated with a non-vitamin K antagonist oral anticoagulant (NOAC) were incorrectly dosed. In total, 50 patients (5%) were overtreated and 89 patients (9%) were undertreated. However, the occurrence of major adverse cardiac and cerebrovascular events (MACCE) was still low with 4.2% (37 patients). Conclusions: Overtreatment and undertreatment with anticoagulants are still observable in 14% of this contemporary, West-European AF population. Still, MACCE occurred in only 4% of the patients after 1 year of follow-up.

2021 - Corrigendum to: 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC (Eur Heart J (2021) 42 (373–498) DOI: 10.1093/eurheartj/ehaa612) [Articolo su rivista]
Hindricks, G.; Potpara, T.; Dagres, N.; Arbelo, E.; Bax, J. J.; Blomstrom-Lundqvist, C.; Boriani, G.; Castella, M.; Dan, G. -A.; Dilaveris, P. E.; Fauchier, L.; Filippatos, G.; Kalman, J. M.; La Meir, M.; Lane, D. A.; Lebeau, J. -P.; Lettino, M.; Lip, G. Y. H.; Pinto, F. J.; Thomas, G. N.; Valgimigli, M.; Van Gelder, I. C.; Van Putte, B. P.; Watkins, C. L.
abstract

Supplementary Table 9, column 'Edoxaban', row 'eGFR category', '95 mL/min' (page 15). The cell should be coloured green instead of yellow. It should also read "60 mg"instead of "60 mg (use with caution in 'supranormal' renal function)."In the above-indicated cell, a footnote has also been added to state: "Edoxaban should be used in patients with high creatinine clearance only after a careful evaluation of the individual thromboembolic and bleeding risk."Supplementary Table 9, column 'Edoxaban', row 'Dose reduction in selected patients' (page 16). The cell should read "Edoxaban 60 mg reduced to 30 mg once daily if any of the following: creatinine clearance 15-50 mL/min, body weight <60 kg, concomitant use of dronedarone, erythromycin, ciclosporine or ketokonazole"instead of "Edoxaban 60 mg reduced to 30 mg once daily, and edoxaban 30 mg reduced to 15mg once daily, if any of the following: creatinine clearance of 30-50 mL/min, body weight <60 kg, concomitant us of verapamil or quinidine or dronedarone."

2021 - Cost-Effectiveness Analyses of an Absorbable Antibacterial Envelope for Use in Patients at Increased Risk of Cardiac Implantable Electronic Device Infection in Germany, Italy, and England [Articolo su rivista]
Boriani, G.; Kennergren, C.; Tarakji, K. G.; Wright, D. J.; Ahmed, F. Z.; Mccomb, J. M.; Goette, A.; Blum, T.; Biffi, M.; Green, M.; Shore, J.; Carion, P. L.; Wilkoff, B. L.
abstract

Objectives: To model the cost-effectiveness of the TYRX Absorbable Antibacterial Envelope when used in patients at increased risk of cardiac implantable electronic device (CIED) infection in the context of 3 European healthcare systems: Germany, Italy, and England. Methods: A decision tree model with a lifetime horizon was populated using data from the Worldwide Randomized Antibiotic Envelope Infection Prevention Trial, a large multicenter randomized controlled trial. Use of the antibacterial envelope adjunctive to standard of care was compared to standard of care infection prevention alone. Patients in the model were divided into subgroups based on presence of factors known to increase infection risk. Results: The antibacterial envelope had the most favorable cost-effectiveness profile when patients had previously experienced CIED infection, had a history of immunosuppressive therapy, or had a Prevention of Arrhythmia Device Infection Trial (PADIT) score indicating high risk of infection (scores ≥6) at cost-effectiveness thresholds of €50 000 in Germany (assumed in the absence of an official threshold), €40 000 in Italy, and £30 000 in England. Probabilistic sensitivity analysis indicated that the antibacterial envelope was likely to be cost-effective in patients with other risk factors (including replacement of high power CIEDs, generator replacement with lead modification, and PADIT scores indicating intermediate risk of infection) when used with some device types and in some countries. Conclusions: The absorbable antibacterial envelope was associated with cost-effectiveness ratios below European benchmarks in selected patients at increased risk of infection, suggesting the envelope provides value for European healthcare systems by reducing CIED infections.

2021 - Cost-minimization analysis of a wearable cardioverter defibrillator in adult patients undergoing ICD explant procedures: Clinical and economic implications [Articolo su rivista]
Boriani, G.; Mantovani, L. G.; Cortesi, P. A.; De Ponti, R.; D'Onofrio, A.; Arena, G.; Curnis, A.; Forleo, G.; Guerra, F.; Porcu, M.; Sgarito, G.; Botto, G. L.
abstract

Aims: Patients with permanently increased risk of sudden cardiac death (SCD) can be protected by implantable cardioverter defibrillators (ICD). If an ICD must be removed due to infection, for example, immediate reimplantation might not be possible or indicated. The wearable cardioverter defibrillator (WCD) is an established, safe and effective solution to protect patients from SCD during this high-risk bridging period. Very few economic evaluations on WCD use are currently available. Methods: We conducted a systematic review to evaluate the available evidence of WCD in patients undergoing ICD explant/lead extraction. Additionally, a decision model was developed to compare use and costs of the WCD with standard therapy (in-hospital stay). For this purpose, a cost-minimization analysis was conducted, and complemented by a one-way sensitivity analysis. Results: In the base case scenario, the WCD was less expensive compared to standard therapy. The cost-minimization analysis showed a cost reduction of €1782 per patient using the WCD. If costs of standard care were changed, cost savings associated with the WCD varied from €3500 to €0, assuming costs for standard care of €6800 to €3600. Conclusion: After ICD explantation, patients can be safely and effectively protected from SCD after hospital discharge through WCD utilization. Furthermore, the use of a WCD for this patient group is cost saving when compared to standard therapy.

2021 - Device-detected atrial high rate episodes and the risk of stroke/thrombo-embolism and atrial fibrillation incidence: a systematic review and meta-analysis [Articolo su rivista]
Vitolo, M.; Imberti, J. F.; Maisano, A.; Albini, A.; Bonini, N.; Valenti, A. C.; Malavasi, V. L.; Proietti, M.; Healey, J. S.; Lip, G. Y.; Boriani, G.
abstract

Background: Atrial High Rate Episodes (AHRE) are asymptomatic atrial tachy-arrhythmias detected through continuous monitoring with a cardiac implantable electronic device. The risks of stroke/Thromboembolic (TE) events and incident clinical Atrial Fibrillation (AF) associated with AHRE varies markedly. Objectives: To assess the relationship between AHRE and TE events, and between AHRE and incident clinical AF. Methods: This systematic review and meta-analysis was conducted following the PRISMA recommendations. PubMed, Scopus, and Google Scholar were searched from inception to 18/02/2021 for studies reporting TE events and incident clinical AF in patients with AHRE, as compared with patients without. Results: Ten out of 8081 records fulfilled the inclusion criteria, for a total of 37 266 patients. Seven out of ten studies excluded patients with prior history of clinical AF (4961 patients), embracing the most recent definition of AHRE. The risk ratio (RR) for TE events in AHRE patients was 2.13 (95% CI: 1.53–2.95, I2: 0%). The incidence of clinical AF was reported in four studies excluding patients with a history of clinical AF (3574 patients). The RR for incident clinical AF was 3.34 (95%CI: 1.89–5.90, I2: 73%). Conclusions: AHRE are significantly associated with systemic thromboembolism and incident clinical AF. Further studies are needed to improve patients' risk stratification and management.

2021 - Digital literacy as a potential barrier to implementation of cardiology tele-visits after COVID-19 pandemic: The INFO-COVID survey [Articolo su rivista]
Boriani, G.; Maisano, A.; Bonini, N.; Albini, A.; Imberti, J. F.; Venturelli, A.; Menozzi, M.; Ziveri, V.; Morgante, V.; Camaioni, G.; Passiatore, M.; de Mitri, G.; Nanni, G.; Girolami, D.; Fontanesi, R.; Siena, V.; Sgreccia, D.; Malavasi, V. L.; Valenti, A. C.; Vitolo, M.
abstract

BACKGROUND During the COVID-19 pandemic, the implementation of telemedicine has represented a new potential option for outpatient care. The aim of our study was to evaluate digital literacy among cardiology outpatients. METHODS From March to June 2020, a survey on telehealth among cardiology outpatients was performed. Digital literacy was investigated through six main domains: age; sex; educational level; internet access; availability of internet sources; knowledge and use of teleconference software programs. RESULTS The study included 1 067 patients, median age 70 years, 41.3% females. The majority of the patients (58.0%) had a secondary school degree, but among patients aged ≥ 75 years old the most represented educational level was primary school or none. Overall, for internet access, there was a splitting between “never” (42.1%) and “every day” (41.0%), while only 2.7% answered “at least 1/month” and 14.2% “at least 1/week”. In the total population, the most used devices for internet access were smartphones (59.0%), and WhatsApp represented the most used app (57.3%). Internet users were younger compared to non-internet users (63 vs. 78 years old, respectively) and with a higher educational level. Age and educational level were associated with non-use of internet (age-per 10-year increase odds ratio (OR) = 3.07, 95% CI: 2.54−3.71, secondary school OR = 0.18, 95% CI: 0.12−0.26, university OR = 0.05, 95% CI: 0.02−0.10). CONCLUSIONS Telemedicine represents an appealing option to implement medical practice, and for its development it is important to address the gaps in patients’ digital skills, with age and educational level being key factors in this setting.

2021 - Echocardiographic Left Ventricular Mass Assessment: Correlation between 2D-Derived Linear Dimensions and 3-Dimensional Automated, Machine Learning-Based Methods in Unselected Patients [Articolo su rivista]
Barbieri, Andrea; Bursi, Francesca; Camaioni, Giovanni; Maisano, Anna; Imberti, Jacopo Francesco; Albini, Alessandro; De Mitri, Gerardo; Mantovani, Francesca; Boriani, Giuseppe
abstract

A recently developed algorithm for 3D analysis based on machine learning (ML) principles detects left ventricular (LV) mass without any human interaction. We retrospectively studied the correlation between 2D-derived linear dimensions using the ASE/EACVI-recommended formula and 3D automated, ML-based methods (Philips HeartModel) regarding LV mass quantification in unselected patients undergoing echocardiography. We included 130 patients (mean age 60 +/- 18 years; 45% women). There was only discrete agreement between 2D and 3D measurements of LV mass (r = 0.662, r(2) = 0.348, p < 0.001). The automated algorithm yielded an overestimation of LV mass compared to the linear method (Bland-Altman positive bias of 13.1 g with 95% limits of the agreement at 4.5 to 21.6 g, p = 0.003, ICC 0.78 (95%CI 0.68-8.4). There was a significant proportional bias (Beta -0.22, t = -2.9) p = 0.005, the variance of the difference varied across the range of LV mass. When the published cut-offs for LV mass abnormality were used, the observed proportion of overall agreement was 77% (kappa = 0.32, p < 0.001). In consecutive patients undergoing echocardiography for any indications, LV mass assessment by 3D analysis using a novel ML-based algorithm showed systematic differences and wide limits of agreements compared with quantification by ASE/EACVI- recommended formula when the current cut-offs and partition values were applied.

2021 - Edoxaban versus Warfarin in Patients with Atrial Fibrillation at the Extremes of Body Weight: An Analysis from the ENGAGE AF-TIMI 48 Trial [Articolo su rivista]
Boriani, G.; Ruff, C. T.; Kuder, J. F.; Shi, M.; Lanz, H. J.; Antman, E. M.; Braunwald, E.; Giugliano, R. P.
abstract

Background The effects of anticoagulants at extremes of body weight (BW) are not well described. The aim of this study was to analyze the pharmacokinetics/pharmacodynamics and clinical outcomes in patients randomized to warfarin, higher dose edoxaban (HDER), and lower dose edoxaban (LDER) regimens at extremes of BW in ENGAGE AF-TIMI 48. Methods and Results We analyzed three BW groups: low BW (LBW: <5th percentile, ≤55 kg, N = 1,082), middle BW (MBW: 45th-55th percentile, 79.8-84 kg, N = 2,153), and high BW (HBW: >95th percentile, ≥120 kg, N = 1,093). In the warfarin arm, LBW patients had higher rates of stroke/systemic embolism (SSE: 6.5 vs. 4.7 in MBW vs. 1.6% in HBW, P trend < 0.001), major bleeding (MB: 9.3 vs. 7.7 vs. 6.5%, P trend = 0.08), and worse net clinical outcome of systemic embolic event, MB, or death (31.5 vs. 19.1 vs. 16.0%, P trend < 0.0001). The time-in-therapeutic range with warfarin was lowest in LBW patients (63.0 vs. 69.3 vs. 70.1% patients, P trend < 0.001). The pharmacokinetic/pharmacodynamic profile of edoxaban was consistent across BW groups. The risk of SSE was similar between HDER and warfarin for each of the three weight groups (P int = 0.52, P int-trend = 0.86). MB was reduced by LDER versus warfarin (P int = 0.061, P int-trend = 0.023), especially in LBW patients. Net clinical outcomes were improved by HDER versus warfarin (P int = 0.087, P int-trend = 0.027), especially in LBW patients. Conclusion Patients with LBW in ENGAGE AF-TIMI 48 had in general a more fragile clinical status and poorer international normalized ratio control. The pharmacokinetic/pharmacodynamic profile of edoxaban was consistent across extremes of BW, resulting in similar efficacy compared with warfarin, while major or clinically relevant non-MB and net outcomes were most favorable with edoxaban as compared to warfarin in LBW patients.

2021 - Effects of sildenafil on right ventricle remodelling in Portopulmonary hypertension [Articolo su rivista]
Rossi, R.; Talarico, M.; Schepis, F.; Coppi, F.; Sgura, F. A.; Monopoli, D. E.; Minici, R.; Boriani, G.
abstract

Portopulmonary hypertension (PoPH) is a clinical condition associated with end‐stage liver disease, described by the coexistence of pulmonary arterial hypertension (PAH) and portal hypertension. In PoPH patients, there is a right ventricle (RV) remodeling to compensate for the increased resistance in the lung circulation. There are no studies on the effects of the PAH-targeted pharmacological treatment on the RV dimension and function. The present study summarizes our experience in patients with PoPH treated with sildenafil in a period of 6 years (from 2013 to 2019). We enrolled 64 consecutive patients identified as PoPH, all treated with sildenafil (57.6% in monotherapy; in the other cases in association with macitentan; in 19.0% with initial combination therapy). A hemodynamic invasive cardiopulmonary study was performed at baseline and after 6 months of sildenafil treatment. In our population we showed a significative improvement in RV performance, with a significant increase in RV stroke volume (+33%), RV ejection fraction (+31%) and RV stroke work index (+17.5%). We registered the reduction of the RV cavity dimension over time in all patients treated with sildenafil (RV end diastolic diameter decreased by 15% after 6 months of follow-up). Regarding diastolic function, we highlighted a very significant reduction in RV end-diastolic pressure (−50% concerning baseline). Sildenafil was effective both when used as monotherapy and in combination with macitentan. In conclusion, Sildenafil had a positive impact on RV systolic and diastolic function in patients with PoPH and was able to conditionate the reverse remodeling of the RV.

2021 - Estimate and reporting of longevity for cardiac implantable electronic devices: a proposal for standardized criteria [Articolo su rivista]
Censi, F.; Calcagnini, G.; Mattei, E.; Ricci, R. P.; Zoni Berisso, M.; Landolina, M.; Boriani, G.
abstract

Background: Cardiac implantable electronic devices (CIEDs) are widely used according to consensus guidelines in various patient categories. The longevity of CIED is a major determinant of the frequency with which patients require device replacement. Given the mismatch between the useful life of the devices and patient survival, device replacement is often needed. There is a great variability in the criteria used by manufacturers to determine the longevity of pacemakers (PM), implantable defibrillators (ICDs), and devices for cardiac resynchronization therapy (CRT). Thus, a fair comparison and an effective device evaluation is often difficult. Methods: The objective of this paper is to provide standardized criteria based on typical clinical settings for estimating the longevity of single and dual chamber ICDs, cardiac resynchronization defibrillators (CRT-D), single and dual chamber PMs, and cardiac resynchronization PMs (CRT- P) to be used in health technology assessment for an appropriate comparison among different devices. Results: The proposed parameters, if applied to the current marketed devices, provide longevity values in the range 5–17.2 years. Conclusion: The values of longevity with the non-standardized criteria used by the manufacturers result in higher maximum values respect to the proposed standardized criteria for CRT-D, CRTD-MPP, CRT-P, and Dual-chamber PM.

2021 - Evaluation and management of cancer patients presenting with acute cardiovascular disease: a Consensus Document of the Acute CardioVascular Care (ACVC) association and the ESC council of Cardio-Oncology-Part 1: acute coronary syndromes and acute pericardial diseases [Articolo su rivista]
Gevaert, Sofie A; Halvorsen, Sigrun; Sinnaeve, Peter R; Sambola, Antonia; Gulati, Geeta; Lancellotti, Patrizio; Van Der Meer, Peter; Lyon, Alexander R; Farmakis, Dimitrios; Lee, Geraldine; Boriani, Giuseppe; Wechalekar, Ashutosh; Okines, Alicia; Asteggiano, Riccardo
abstract

Advances in treatment, common cardiovascular (CV) risk factors and the ageing of the population have led to an increasing number of cancer patients presenting with acute CV diseases. These events may be related to the cancer itself or the cancer treatment. Acute cardiac care specialists must be aware of these acute CV complications and be able to manage them. This may require an individualized and multidisciplinary approach. We summarize the most common acute CV complications of cytotoxic, targeted, and immune-based therapies. This is followed by a proposal for a multidisciplinary approach where acute cardiologists work close together with the treating oncologists, haematologists, and radiation specialists, especially in situations where immediate therapeutic decisions are needed. In this first part, we further focus on the management of acute coronary syndromes and acute pericardial diseases in patients with cancer.

2021 - Grey zones in the practice of permanent cardiac pacing: The case of preventive pacing for improving rhythm control in atrial fibrillation [Articolo su rivista]
Boriani, G.; Vitolo, M.
abstract

2021 - Grupul de lucru pentru diagnosticul şi tratamentul fi brilaţiei atriale al societăţii europene de cardiologie (Esc) [Articolo su rivista]
Hindricks, G.; Potpara, T.; Dagres, N.; Arbelo, E.; Bax, J. J.; Blomstrom-Lundqvist, C.; Boriani, G.; Castella, M.; Dan, G. -A.; Dilaveris, P. E.; Fauchier, L.; Filippatos, G.; Kalman, J. M.; La Meir, M.; Lane, D. A.; Lebeau, J. -P.; Lettino, M.; Lip, G. Y. H.; Pinto, F. J.; Neil Thomas, G.; Valgimigli, M.; Van Gelder, I. C.; Van Putte, B. P.; Watkins, C. L.
abstract

2021 - High sensitivity C-reactive protein (hsCRP) and its implications in cardiovascular outcomes [Articolo su rivista]
Denegri, Andrea; Boriani, Giuseppe
abstract

Atherosclerosis and its fearsome complications represent the first cause of morbidity and mortality worldwide. Over the last two decades, several evidences have been accumulated, suggesting a central role for inflammation in atheroma development. High sensitivity C-reactive protein (hsCRP) is a well-established marker of cardiovascular (CV) disease; high levels of hsCRP have been associated with adverse CV outcome after acute coronary syndrome (ACS) and, despite some controversy, an active role for hsCRP in initiation and development of the atherosclerotic plaque has been also proposed. Randomized clinical trials focusing on hsCRP have been crucial in elucidating the anti-inflammatory effects of statin therapy. Thus, hsCRP has been progressively considered a real CV risk factor likewise to low-density lipoprotein cholesterol (LDL-C), rising the concept of residual CV inflammatory risk. Subsequent research has been designed to investigate potential new targets of atherothrombotic protection. Despite clinical usefulness of hsCRP is widely recognized, hsCRP may not represent the ideal target of specific anti-inflammatory therapies. Clinical investigations, therefore, have focused also on other inflammatory mediators, restricting hsCRP to an indicator rather than a therapeutic target. The aim of the present review is to provide an illustrative overview on the current knowledge of atherosclerosis and inflammation, highlighting the most representative clinical studies of lipid lowering- and antiinflammatory therapies focused on hsCRP in CV diseases.

2021 - How did COVID-19 affect medical and cardiology journals? A pandemic in literature [Articolo su rivista]
Venturelli, A.; Vitolo, M.; Albini, A.; Boriani, G.
abstract

BACKGROUND AND AIMS: The spreading speed of the COVID-19 pandemic forced the medical community to produce efforts in updating and sharing the evidence about this new disease, trying to preserve the accuracy of the data but at the same time avoiding the potentially harmful delay from discovery to implementation. The aim of our analysis was to assess the impact of the COVID-19 pandemic on medical literature in terms of proportion of COVID-19-related published papers and temporal patterns of publications within a sample of general/internal medicine and cardiology journals. METHODS: We searched through PubMed scientific papers published from 1 January 2020 to 31 January 2021 about COVID-19 in ten major medical journals, of which five were in general/internal medicine and five in the cardiology field. We analyzed the proportion of COVID-19-related papers, and we examined temporal trends in the number of published papers. RESULTS: Overall, the proportion of COVID-19-related papers was 18.5% (1986/10 756). This proportion was higher among the five selected general/internal medicine journals, compared with cardiology journals (23.8% vs 9.5%). The vast majority of papers were not original articles; in particular, in cardiology journals, there were 28% 'original articles', 17% 'review articles' and 55.1% 'miscellaneous', compared with 20.2%, 5.1% and 74.7% in general/internal medicine journals, respectively. CONCLUSIONS: Our analysis highlights the big impact of the COVID-19 pandemic on international scientific literature. General and internal medicine journals were mainly involved, with cardiology journals only at a later time.

2021 - Impact of Weight on Clinical Outcomes of Edoxaban Therapy in Atrial Fibrillation Patients Included in the ETNA-AF-Europe Registry [Articolo su rivista]
Boriani, Giuseppe; De Caterina, Raffaele; Manu, Marius Constantin; Souza, José; Pecen, Ladislav; Kirchhof, Paulus
abstract

Background: Extremes of body weight may alter exposure to non-vitamin K antagonist oral anticoagulants and thereby impact clinical outcomes. This ETNA-AF-Europe sub-analysis assessed 1-year outcomes in routine care patients with atrial fibrillation across a range of body weight groups treated with edoxaban. Methods: ETNA-AF-Europe is a multinational, multicentre, observational study conducted in 825 sites in 10 European countries. Overall, 1310, 5565, 4346 and 1446 enrolled patients were categorised into <= 60 kg, >60-<= 80 kg (reference weight group), >80-<= 100 kg and >100 kg groups. Results: Patients weighing <= 60 kg were older, more frail and had a higher CHA(2)DS(2)-VASc score vs. the other weight groups. The rates of stroke/systemic embolism, major bleeding and ICH were low at 1 year (0.82, 1.05 and 0.24%/year), with no significant differences among weight groups. The annualised event rates of all-cause death were 3.50%/year in the overall population. After adjustment for eGFR and CHA(2)DS(2)-VASc score, the risk of all-cause death was significantly higher in extreme weight groups vs. the reference group. Conclusions: Low rates of stroke and bleeding were reported with edoxaban, independent of weight. The risk of all-cause death was higher in extremes of weight vs. the reference group after adjustment for important risk modifiers, thus no obesity paradox was observed.

2021 - Impact of clinical phenotypes on management and outcomes in European atrial fibrillation patients: a report from the ESC-EHRA EURObservational Research Programme in AF (EORP-AF) General Long-Term Registry [Articolo su rivista]
Proietti, M.; Vitolo, M.; Harrison, S. L.; Lane, D. A.; Fauchier, L.; Marin, F.; Nabauer, M.; Potpara, T. S.; Dan, G. -A.; Boriani, G.; Lip, G. Y. H.; Boriani (Chair), G.; Lip, G. Y. H.; Tavazzi, L.; Maggioni, A. P.; Dan, G. -A.; Potpara, T.; Nabauer, M.; Marin, F.; Kalarus, Z.; Fauchier, L.; Ferrari, R.; Shantsila, A.; Goda, A.; Mairesse, G.; Shalganov, T.; Antoniades, L.; Taborsky, M.; Riahi, S.; Muda, P.; Garcia Bolao, I.; Piot, O.; Nabauer, M.; Etsadashvili, K.; Simantirakis, E. N.; Haim, M.; Azhari, A.; Najafian, J.; Santini, M.; Mirrakhimov, E.; Kulzida, K.; Erglis, A.; Poposka, L.; Burg, M. R.; Crijns, H.; Erkuner, O.; Atar, D.; Lenarczyk, R.; Martins Oliveira, M.; Shah, D.; Dan, G. -A.; Serdechnaya, E.; Potpara, T.; Diker, E.; Lip, G. Y. H.; Lane, D.; Zera, E.; Ekmekciu, U.; Paparisto, V.; Tase, M.; Gjergo, H.; Dragoti, J.; Goda, A.; Ciutea, M.; Ahadi, N.; el Husseini, Z.; Raepers, M.; Leroy, J.; Haushan, P.; Jourdan, A.; Lepiece, C.; Desteghe, L.; Vijgen, J.; Koopman, P.; Van Genechten, G.; Heidbuchel, H.; Boussy, T.; De Coninck, M.; Van Eeckhoutte, H.; Bouckaert, N.; Friart, A.; Boreux, J.; Arend, C.; Evrard, P.; Stefan, L.; Hoffer, E.; Herzet, J.; Massoz, M.; Celentano, C.; Sprynger, M.; Pierard, L.; Melon, P.; Van Hauwaert, B.; Kuppens, C.; Faes, D.; Van Lier, D.; Van Dorpe, A.; Gerardy, A.; Deceuninck, O.; Xhaet, O.; Dormal, F.; Ballant, E.; Blommaert, D.; Yakova, D.; Hristov, M.; Yncheva, T.; Stancheva, N.; Tisheva, S.; Tokmakova, M.; Nikolov, F.; Gencheva, D.; Shalganov, T.; Kunev, B.; Stoyanov, M.; Marchov, D.; Gelev, V.; Traykov, V.; Kisheva, A.; Tsvyatkov, H.; Shtereva, R.; Bakalska-Georgieva, S.; Slavcheva, S.; Yotov, Y.; Kubickova, M.; Marni Joensen, A.; Gammelmark, A.; Hvilsted Rasmussen, L.; Dinesen, P.; Riahi, S.; Krogh Veno, S.; Sorensen, B.; Korsgaard, A.; Andersen, K.; Fragtrup Hellum, C.; Svenningsen, A.; Nyvad, O.; Wiggers, P.; May, O.; Aarup, A.; Graversen, B.; Jensen, L.; Andersen, M.; Svejgaard, M.; Vester, S.; Hansen, S.; Lynggaard, V.; Ciudad, M.; Vettus, R.; Muda, P.; Maestre, A.; Castano, S.; Cheggour, S.; Poulard, J.; Mouquet, V.; Leparree, S.; Bouet, J.; Taieb, J.; Doucy, A.; Duquenne, H.; Furber, A.; Dupuis, J.; Rautureau, J.; Font, M.; Damiano, P.; Lacrimini, M.; Abalea, J.; Boismal, S.; Menez, T.; Mansourati, J.; Range, G.; Gorka, H.; Laure, C.; Vassaliere, C.; Elbaz, N.; Lellouche, N.; Djouadi, K.; Roubille, F.; Dietz, D.; Davy, J.; Granier, M.; Winum, P.; Leperchois-Jacquey, C.; Kassim, H.; Marijon, E.; Le Heuzey, J.; Fedida, J.; Maupain, C.; Himbert, C.; Gandjbakhch, E.; Hidden-Lucet, F.; Duthoit, G.; Badenco, N.; Chastre, T.; Waintraub, X.; Oudihat, M.; Lacoste, J.; Stephan, C.; Bader, H.; Delarche, N.; Giry, L.; Arnaud, D.; Lopez, C.; Boury, F.; Brunello, I.; Lefevre, M.; Mingam, R.; Haissaguerre, M.; Le Bidan, M.; Pavin, D.; Le Moal, V.; Leclercq, C.; Piot, O.; Beitar, T.; Martel, I.; Schmid, A.; Sadki, N.; Romeyer-Bouchard, C.; Da Costa, A.; Arnault, I.; Boyer, M.; Piat, C.; Fauchier, L.; Lozance, N.; Nastevska, S.; Doneva, A.; Fortomaroska Milevska, B.; Sheshoski, B.; Petroska, K.; Taneska, N.; Bakrecheski, N.; Lazarovska, K.; Jovevska, S.; Ristovski, V.; Antovski, A.; Lazarova, E.; Kotlar, I.; Taleski, J.; Poposka, L.; Kedev, S.; Zlatanovik, N.; Jordanova, S.; Bajraktarova Proseva, T.; Doncovska, S.; Maisuradze, D.; Esakia, A.; Sagirashvili, E.; Lartsuliani, K.; Natelashvili, N.; Gumberidze, N.; Gvenetadze, R.; Etsadashvili, K.; Gotonelia, N.; Kuridze, N.; Papiashvili, G.; Menabde, I.; Gloggler, S.; Napp, A.; Lebherz, C.; Romero, H.; Schmitz, K.; Berger, M.; Zink, M.; Koster, S.; Sachse, J.; Vonderhagen, E.; Soiron, G.; Mischke, K.; Reith, R.; Schneider, M.; Rieker, W.; Boscher, D.; Taschareck, A.; Beer, A.; Oster, D.; Ritter, O.; Adamczewski, J.; Walter, S.; Frommhold, A.; Luckner, E.; Richter, J.; Schellner, M.; Landgraf, S.; Bartholome, S.; Naumann, R.; Schoeler, J.; Westermeier, D.; William, F.; Wilhelm, K.; Maerkl, M.; Oekinghaus, R.; Denart, M.; Kriete, M.; Tebbe, U.; Sche
abstract

Background: Epidemiological studies in atrial fibrillation (AF) illustrate that clinical complexity increase the risk of major adverse outcomes. We aimed to describe European AF patients’ clinical phenotypes and analyse the differential clinical course. Methods: We performed a hierarchical cluster analysis based on Ward’s Method and Squared Euclidean Distance using 22 clinical binary variables, identifying the optimal number of clusters. We investigated differences in clinical management, use of healthcare resources and outcomes in a cohort of European AF patients from a Europe-wide observational registry. Results: A total of 9363 were available for this analysis. We identified three clusters: Cluster 1 (n = 3634; 38.8%) characterized by older patients and prevalent non-cardiac comorbidities; Cluster 2 (n = 2774; 29.6%) characterized by younger patients with low prevalence of comorbidities; Cluster 3 (n = 2955;31.6%) characterized by patients’ prevalent cardiovascular risk factors/comorbidities. Over a mean follow-up of 22.5 months, Cluster 3 had the highest rate of cardiovascular events, all-cause death, and the composite outcome (combining the previous two) compared to Cluster 1 and Cluster 2 (all P <.001). An adjusted Cox regression showed that compared to Cluster 2, Cluster 3 (hazard ratio (HR) 2.87, 95% confidence interval (CI) 2.27–3.62; HR 3.42, 95%CI 2.72–4.31; HR 2.79, 95%CI 2.32–3.35), and Cluster 1 (HR 1.88, 95%CI 1.48–2.38; HR 2.50, 95%CI 1.98–3.15; HR 2.09, 95%CI 1.74–2.51) reported a higher risk for the three outcomes respectively. Conclusions: In European AF patients, three main clusters were identified, differentiated by differential presence of comorbidities. Both non-cardiac and cardiac comorbidities clusters were found to be associated with an increased risk of major adverse outcomes.

2021 - Impact of covid-19 pandemic on remote monitoring of cardiac implantable electronic devices in italy: Results of a survey promoted by aiac (italian association of arrhythmology and cardiac pacing) [Articolo su rivista]
Maines, M.; Palmisano, P.; Del Greco, M.; Melissano, D.; De Bonis, S.; Baccillieri, S.; Zanotto, G.; D'onofrio, A.; Ricci, R. P.; De Ponti, R.; Boriani, G.
abstract

The COVID-19 pandemic has had a profound impact on the organisation of health care in Italy, with an acceleration in the development of telemedicine. To assess the impact of the COVID-19 pandemic on the spread of remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) in Italy, a survey addressed to cardiologists operating in all Italian CIED-implanting centres was launched. A total of 127 cardiologists from 116 Italian arrhythmia centres took part in the survey, 41.0% of all 283 CIED-implanting centres operating in Italy in 2019. All participating centres declared to use RM of CIEDs. COVID-19 pandemic resulted in an increase in the use of RM in 83 (71.6%) participating centres. In a temporal perspective, an increase in the median number of patients per centre followed up by RM was found from 2012 to 2017, followed by an exponential increase from 2017 to 2020. In 36 participating centres (31.0%) a telehealth visits service was activated as a replacement for in-person outpatient visits (in patients with or without CIED) during the COVID-19 pandemic. COVID-19 pandemic has caused an acceleration in the use of RM of CIEDs and in the use of telemedicine in the clinical practice of cardiology.

2021 - Implantation of cardiac electronic devices in active COVID-19 patients: Results from an international survey [Articolo su rivista]
Tovia-Brodie, Oholi; Acha, Moshe Rav; Belhassen, Bernard; Gasperetti, Alessio; Schiavone, Marco; Forleo, Giovanni Battista; Guevara-Valdivia, Milton E; Ruiz, David Valdeolivar; Lellouche, Nicolas; Hamon, David; Castagno, Davide; Bellettini, Matteo; De Ferrari, Gaetano M; Laredo, Mikael; Carvès, Jean-Baptiste; Ignatiuk, Barbara; Pasquetto, Giampaolo; De Filippo, Paolo; Malanchini, Giovanni; Pavri, Behzad B; Raphael, Craig; Rivetti, Luigi; Mantovan, Roberto; Chinitz, Jason; Harding, Melissa; Boriani, Giuseppe; Casali, Edoardo; Wan, Elaine Y; Biviano, Angelo; Macias, Carlos; Havranek, Stepan; Lazzerini, Pietro Enea; Canu, Antonio M; Zardini, Marco; Conte, Giulio; Cano, Óscar; Casella, Michela; Rudic, Boris; Omelchenko, Alexander; Mathuria, Nilesh; Upadhyay, Gaurav A; Danon, Asaf; Schwartz, Arie Lorin; Maury, Philippe; Nakahara, Shiro; Goldenberg, Gustavo; Schaerli, Nicolas; Bereza, Sergiy; Auricchio, Angelo; Glikson, Michael; Michowitz, Yoav
abstract

Background: Cardiac implantable electronic device (CIED) implantation rates as well as the clinical and procedural characteristics and outcomes in patients with known active coronavirus disease 2019 (COVID-19) are unknown. Objective: The purpose of this study was to gather information regarding CIED procedures during active COVID-19, performed with personal protective equipment, based on an international survey. Methods: Fifty-three centers from 13 countries across 4 continents provided information on 166 patients with known active COVID-19 who underwent a CIED procedure. Results: The CIED procedure rate in 133,655 hospitalized COVID-19 patients ranged from 0 to 16.2 per 1000 patients (P <.001). Most devices were implanted due to high-degree/complete atrioventricular block (112 [67.5%]) or sick sinus syndrome (31 [18.7%]). Of the 166 patients in the study survey, the 30-day complication rate was 13.9% and the 180-day mortality rate was 9.6%. One patient had a fatal outcome as a direct result of the procedure. Differences in patient and procedural characteristics and outcomes were found between Europe and North America. An older population (76.6 vs 66 years; P <.001) with a nonsignificant higher complication rate (16.5% vs 7.7%; P = .2) was observed in Europe vs North America, whereas higher rates of critically ill patients (33.3% vs 3.3%; P <.001) and mortality (26.9% vs 5%; P = .002) were observed in North America vs Europe. Conclusion: CIED procedure rates during known active COVID-19 disease varied greatly, from 0 to 16.2 per 1000 hospitalized COVID-19 patients worldwide. Patients with active COVID-19 infection who underwent CIED implantation had high complication and mortality rates. Operators should take these risks into consideration before proceeding with CIED implantation in active COVID-19 patients.

2021 - In- and out-of-hospital mortality for myocardial infarction during the first wave of the COVID-19 pandemic in Emilia-Romagna, Italy: A population-based observational study [Articolo su rivista]
Campo, G.; Fortuna, D.; Berti, E.; De Palma, R.; Pasquale, G. D.; Galvani, M.; Navazio, A.; Piovaccari, G.; Rubboli, A.; Guardigli, G.; Galie, N.; Boriani, G.; Tondi, S.; Ardissino, D.; Piepoli, M.; Banchelli, F.; Santarelli, A.; Casella, G.
abstract

Background: The COVID-19 pandemic has put several healthcare systems under severe pressure. The present analysis investigates how the first wave of the COVID-19 pandemic affected the myocardial infarction (MI) network of Emilia-Romagna (Italy). Methods: Based on Emilia-Romagna mortality registry and administrative data from all the hospitals from January 2017 to June 2020, we analysed: i) temporal trend in MI hospital admissions; ii) characteristics, management, and 30-day mortality of MI patients; iii) out-of-hospital mortality for cardiac cause. Findings: Admissions for MI declined on February 22, 2020 (IRR -19.5%, 95%CI from -8.4% to -29.3%, p = 0.001), and further on March 5, 2020 (IRR -21.6%, 95%CI from -9.0% to -32.5%, p = 0.001). The return to pre-COVID-19 MI-related admission levels was observed from May 13, 2020 (IRR 34.3%, 95%CI 20.0%-50.2%, p<0.001). As compared to those before the pandemic, MI patients admitted during and after the first wave were younger and with fewer risk factors. The 30-day mortality remained in line with that expected based on previous years (ratio observed/expected was 0.96, 95%CI 0.84–1.08). MI patients positive for SARS-CoV-2 were few (1.5%) but showed poor prognosis (around 5-fold increase in 30-day mortality). In 2020, the number of out-of-hospital cardiac deaths was significantly higher (ratio observed/expected 1.17, 95%CI 1.08–1.27). The peak was reached in April. Interpretation: In Emilia-Romagna, MI hospitalizations significantly decreased during the first wave of the COVID-19 pandemic. Management and outcomes of hospitalized MI patients remained unchanged, except for those with SARS-CoV-2 infection. A concomitant increase in the out-of-hospital cardiac mortality was observed. Funding: None.

2021 - Infections associated with cardiac electronic implantable devices: economic perspectives and impact of the TYRX™ antibacterial envelope [Articolo su rivista]
Boriani, G.; Vitolo, M.; Wright, D. J.; Biffi, M.; Brown, B.; Tarakji, K. G.; Wilkoff, B. L.
abstract

The occurrence of cardiac implantable electronic devices (CIED) infections and related adverse outcomes have an important financial impact on the healthcare system, with hospitalization length of stay (2-3 weeks on average) being the largest cost driver, including the cost of device system extraction and device replacement accounting for more than half of total costs. In the recent literature, the economic profile of the TYRX™ absorbable antibacterial envelope was analysed taking into account both randomized and non-randomized trial data. Economic analysis found that the envelope is associated with cost-effectiveness ratios below USA and European benchmarks in selected patients at increased risk of infection. Therefore, the TYRX™ envelope, by effectively reducing CIED infections, provides value according to the criteria of affordability currently adopted by USA and European healthcare systems.

2021 - Infective endocarditis with perivalvular abscess complicated by septic embolization with acute ST-segment elevation myocardial infarction and peripheral ischemia [Articolo su rivista]
Denegri, A.; Venturelli, A.; Boriani, G.
abstract

2021 - Inhibition of lysyl oxidase stimulates TGF-β signaling and metalloproteinases-2 and -9 expression and contributes to the disruption of ascending aorta in rats: protection by propylthiouracil [Articolo su rivista]
Merico, V.; Imberti, J. F.; Zanoni, M.; Boriani, G.; Garagna, S.; Imberti, R.
abstract

Mutations in lysyl oxidase (LOX) genes cause severe vascular anomalies in mice and humans. LOX activity can be irreversibly inhibited by the administration of β-aminoproprionitrile (BAPN). We investigated the mechanisms underlying the damage to the ascending thoracic aorta induced by LOX deficiency and evaluated whether 6-propylthiouracil (PTU) can afford protection in rats. BAPN administration caused disruption of the ascending aortic wall, increased the number of apoptotic cells, stimulated TGF-β signaling (increase of nuclear p-SMAD2 staining), and up-regulated the expression of metalloproteinases-2 and -9. In BAPN-treated animals, PTU reduced apoptosis, p-SMAD2 staining, MMP-2, and -9 expression, and markedly decreased the damage to the aortic wall. Our results suggest that, as in some heritable vascular diseases, enhanced TGF-β signaling and upregulation of MMP-2 and -9 can contribute to the pathogenesis of ascending aorta damage caused by LOX deficiency. We have also shown that PTU, a drug already in clinical use, protects against the effects of LOX inhibition. MMP-2 and -9 might be potential targets of new therapeutic strategies for the treatment of vascular diseases caused by LOX deficiency.

2021 - Long-term outcomes of postoperative atrial fibrillation following non cardiac surgery: A systematic review and metanalysis [Articolo su rivista]
Albini, A.; Malavasi, V. L.; Vitolo, M.; Imberti, J. F.; Marietta, M.; Lip, G. Y. H.; Boriani, G.
abstract

Background: New-onset atrial fibrillation (AF) in non-cardiac postoperative setting is common and is associated with a high risk of in-hospital mortality and morbidity. The long-term risks of stroke, mortality and AF recurrence rate in patients with postoperative AF (POAF) are unclear. Methods: We performed a systematic literature review in electronic databases from inception to March 5th, 2020 of studies reporting the incidence of stroke, mortality and AF recurrence in patients with POAF. We confined our analysis to studies with a cohort of at least 150 patients with POAF and with a median follow-up of 12 months as a minimum. Odds Ratios (OR) were pooled using a random-effects model. Results: Qualitative analysis included 8 studies (7 observational cohort studies and 1 randomized controlled trial) enrolling 3,718,587 patients. Six studies underwent metanalysis comprising 17,684 postoperative patients with POAF and 2,169,248 postoperative patients without POAF. The development of POAF conferred a four-fold increased risk of stroke in the long-term [OR 4.05; 95% confidence interval (CI) 2.91–5.62]. Mortality in the two studies reporting long-term data was higher in patients with POAF compared to those without POAF (OR 3.59; CI 95% 2.84–4.53). Data about recurrence were too heterogeneous to undergo metanalysis. Conclusions: POAF is associated with a greater risk of stroke and mortality over the long-term period. Studies focusing on AF recurrence are needed to address the perception of POAF as a benign transient entity. The increased mortality risk following POAF should encourage systematic detection and prevention of this arrhythmia.

2021 - Medical therapies for prevention of cardiovascular and renal events in patients with atrial fibrillation and diabetes mellitus [Articolo su rivista]
Fauchier, Laurent; Boriani, Giuseppe; de Groot, Joris R; Kreutz, Reinhold; Rossing, Peter; Camm, A John
abstract

2021 - Optimized implementation of cardiac resynchronization therapy: a call for action for referral and optimization of care: A joint position statement from the Heart Failure Association (HFA), European Heart Rhythm Association (EHRA), and European Association of Cardiovascular Imaging (EACVI) of the European Society of Cardiology [Articolo su rivista]
Mullens, Wilfried; Auricchio, Angelo; Martens, Pieter; Witte, Klaus; Cowie, Martin R; Delgado, Victoria; Dickstein, Kenneth; Linde, Cecilia; Vernooy, Kevin; Leyva, Francisco; Bauersachs, Johann; Israel, Carsten W; Lund, Lars H; Donal, Erwan; Boriani, Giuseppe; Jaarsma, Tiny; Berruezo, Antonio; Traykov, Vassil; Yousef, Zaheer; Kalarus, Zbigniew; Nielsen, Jens Cosedis; Steffel, Jan; Vardas, Panos; Coats, Andrew; Seferovic, Petar; Edvardsen, Thor; Heidbuchel, Hein; Ruschitzka, Frank; Leclercq, Christophe
abstract

: Cardiac resynchronization therapy (CRT) is one of the most effective therapies for heart failure with reduced ejection fraction and leads to improved quality of life, reductions in heartfailure hospitalization rates and reduces all-cause mortality. Nevertheless, up to two-thirds ofeligible patients are not referred for CRT. Furthermore, post implantation follow-up is oftenfragmented and suboptimal, hampering the potential maximal treatment effect. This jointposition statement from three ESC Associations, HFA, EHRA and EACVI focuses onoptimized implementation of CRT. We offer theoretical and practical strategies to achievemore comprehensive CRT referral and post-procedural care by focusing on four actionabledomains; (I) overcoming CRT under-utilization, (II) better understanding of pre-implantcharacteristics, (III) abandoning the term 'non-response' and replacing this by the concept ofdisease modification, and (IV) implementing a dedicated post-implant CRT care pathway.

2021 - Optimizing indices of atrial fibrillation susceptibility and burden to evaluate atrial fibrillation severity, risk and outcomes [Articolo su rivista]
Boriani, Giuseppe; Vitolo, Marco; Diemberger, Igor; Proietti, Marco; Valenti, Anna Chiara; Malavasi, Vincenzo Livio; Lip, Gregory Y H
abstract

2021 - Organization and procedures in contemporary catheter ablation centres: data from the 2018 Italian Catheter Ablation Registry [Articolo su rivista]
Stabile, G.; Bertaglia, E.; Guerra, F.; Palmisano, P.; Zoni Berisso, M.; Soldati, E.; Bisignani, G.; Forleo, G. B.; Zanotto, G.; Landolina, M.; Boriani, G.; D'Onofrio, A.; De Ponti, R.; Ricci, R. P.
abstract

AIMS: This report describes the findings of the 2018 Italian Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC). METHODS: The Italian Catheter Ablation Registry systematically collects data on the ablation procedures performed in Italy. Data collection was retrospective. A standardized questionnaire was completed by participating centres. RESULTS: We collected data on 15 714 catheter ablation procedures performed in Italy during 2018 in 94 electrophysiology centres. In most centres (75/94, 80%), a single electrophysiology laboratory was available, and a hybrid electrophysiology laboratory was available in 15% (14/94) of centres. In most (93%) centres, at least two electrophysiologists were involved in the catheter ablation procedures. In only 13 out of 94 (14%) electrophysiology laboratories, an anaesthesiologist assists every electrophysiology procedure; in most cases (74/94, 79%), an on-demand anaesthesiology service was available. On-site cardiothoracic surgery was reported in 43 out of 94 (46%) centres.Nonfluoroscopic navigation systems were available in most centres (88/94, 93%). Intracardiac echocardiography was used in 59 out of 94 (63%) electrophysiology laboratories. Atrial fibrillation (31%) was the most frequently treated ablation target, followed by atrioventricular nodal re-entrant tachycardia (20%) and cavo-tricuspid isthmus (15%). In 61.7% of all procedures, a 3D mapping system was used. In about one-third of procedures, a near-zero approach was performed. CONCLUSION: In most Italian electrophysiology centres, a single electrophysiology laboratory was available and at least two electrophysiologists were involved in the ablation procedures. An increasing number of procedures were performed by means of a nonfluoroscopic mapping system with a near-zero approach.

2021 - Outcomes of digoxin vs. beta-blocker in AF: report from ESC-EHRA EORP-AF Long-Term General Registry [Articolo su rivista]
Ding, Wern Yew; Boriani, Giuseppe; Marin, Francisco; Blomström-Lundqvist, Carina; Potpara, Tatjana S; Fauchier, Laurent; Lip, Gregory Y H
abstract

Background: The safety of digoxin therapy in atrial fibrillation (AF) remains ill-defined. We aimed to evaluate the effects of digoxin over beta-blocker therapy in AF. Methods: Patients with AF who were treated with either digoxin or beta-blocker from the ESC-EHRA EORP-AF General Long-Term Registry were included. Outcomes of interest were all-cause mortality, cardiovascular (CV) mortality, non-CV mortality, quality of life and number of patients with unplanned hospitalisations. Results: Of 6377 patients, 549(8.6%) were treated with digoxin. Over 24 months, there were 550(8.6%) all-cause mortality events and 1304(23.6%) patients with unplanned emergency hospitalisations. Compared to beta-blocker, digoxin therapy was associated with increased all-cause mortality (HR 1.90 [95%CI,1.48-2.44], CV mortality (HR 2.18 [95%CI,1.47-3.21] and non-CV mortality (HR 1.68 [95%CI,1.02-2.75] with reduced quality of life (Health Utility Score 0.555[±0.406] vs. 0.705[±0.346], P<0.001) but no differences in emergency hospitalisations (HR 1.00 [95%CI,0.56-1.80]) or AF-related hospitalisations (HR 0.95 [95%CI,0.60-1.52]).On multivariable analysis, there were no differences in any of the outcomes between both groups, after accounting for potential confounders. Similar results were obtained in the subgroups of patients with permanent AF and coexisting heart failure. There was no differences in outcomes between AF patients receiving digoxin with and without chronic kidney disease. Conclusion: Poor outcomes related to the use of digoxin over beta-blocker therapy in terms of excess mortality and reduced quality of life are associated with the presence of other risk factors rather than digoxin per se. The choice of digoxin or beta-blocker therapy had no influence on the incidence of unplanned hospitalisations.

2021 - Percorso clinico decisionale nel paziente anziano fragile con fibrillazione atriale: La proposta di un gruppo di lavoro multidisciplinare [Clinical management of older, frail patients with atrial fibrillation. The proposal of a multidisciplinary working group] [Articolo su rivista]
Marchionni, N; Fumagalli, S; Bo, M; Boccanelli, A; Boriani, G; Rubboli, A; Violi, F; Di Pasquale, G
abstract

Atrial fibrillation (AF) is the most common arrhythmia in elderly people. Older patients with AF have several comorbidities and should be treated with complex therapeutic schemes. Arrhythmia complications are also common at an advanced age. Accordingly, AF can be considered a marker of frailty. Few indications can be found concerning the management of frail older subjects in current guidelines. The Frailty in Atrial Fibrillation Survey Study (FAST) was designed to overcome the gap of knowledge about this extremely vulnerable subset of patients. A multidisciplinary team composed by cardiologists, geriatricians and internists participated in the project. In a first phase, a survey was conducted aiming at clarifying specialty-related differences in definition and oral anticoagulant therapy (OAT) management of frail individuals. In the second phase, specific chapters were prepared about AF and frailty epidemiology, the network for the management of the arrhythmia, the diagnostic strategies for AF (including a minimum data set of tools derived from the geriatric multidimensional assessment), OAT and the choice between a rate or a rhythm control strategy. For each chapter, up-to-date evidence and current guideline recommendations were presented and discussed among the 47 Italian centers participating in the project. In the last phase of FAST, the results of the survey and the final draft of the chapters were merged into the present document. A lack of homogeneity in frailty definition existed. The integration among cardiologists, geriatricians and internists can represent the most effective tool to get through these differences improving the management of frail older patients.

2021 - Percutaneous pericardiocentesis for pericardial effusion: predictors of mortality and outcomes [Articolo su rivista]
Pennacchioni, A.; Nanni, G.; Sgura, F. A.; Imberti, J. F.; Monopoli, D. E.; Rossi, R.; Longo, G.; Arrotti, S.; Vitolo, M.; Boriani, G.
abstract

Pericardial effusion can dangerously precipitate patient’s hemodynamic stability and requires prompt intervention in case of tamponade. We investigated potential predictors of in-hospital mortality, a composite outcome of in-hospital mortality, pericardiocentesis-related complications, and the need for emergency cardiac surgery and all-cause mortality in patients undergoing percutaneous pericardiocentesis. This is an observational, retrospective, single-center study on patients undergoing percutaneous pericardiocentesis (2010–2019). We enrolled 81 consecutive patients. Median age was 71.4 years (interquartile range [IQR] 58.1–78.1 years) and 51 (63%) were male. Most of the pericardiocentesis were performed in an urgency setting (76.5%) for cardiac tamponade (77.8%). The most common etiology was idiopathic (33.3%) followed by neoplastic (22.2%). In-hospital mortality was 14.8% while mortality during follow-up (mean 17.1 months) was 44.4%. Only hemodynamic instability (i.e., cardiogenic shock, hypotension refractory to fluid challenge therapy and inotropes) was associated with in-hospital mortality at the univariate analysis (odds ratio [OR] 7.2; 95% confidence interval [CI] 1.76–29.4). Non-neoplastic/non-idiopathic etiology and hemodynamic instability were associated with the composite outcome of in-hospital mortality, need for emergency cardiac surgery, or pericardiocentesis-related complications (OR 5.75, 95% CI 1.65–20.01, and OR 5.81, 95% CI 2.11–15.97, respectively). Multivariate Cox regression analysis adjusted for possible confounding variables (age, coronary artery disease, and hemodynamic instability) showed that neoplastic etiology was independently associated with medium-term mortality (hazard ratio [HR] 4.05, 95% CI 1.45–11.36). In a real-world population treated with pericardiocentesis for pericardial effusion, in-hospital adverse outcomes and medium-term mortality are consistent, in particular for patients presenting with hemodynamic instability or neoplastic pericardial effusion.

2021 - Permanent Atrial Fibrillation as the Terminal Stage of a Chronic Disease: Palliative Care Needs to be Considered in Selected Patients with Markedly Impaired Quality of Life [Articolo su rivista]
Boriani, G.; Valenti, A. C.; Vitolo, M.
abstract

2021 - Prevalence, management and impact of chronic obstructive pulmonary disease in atrial fibrillation: a systematic review and meta-analysis of 4,200,000 patients [Articolo su rivista]
Romiti, Giulio Francesco; Corica, Bernadette; Pipitone, Eugenia; Vitolo, Marco; Raparelli, Valeria; Basili, Stefania; Boriani, Giuseppe; Harari, Sergio; Lip, Gregory Y H; Proietti, Marco
abstract

Prevalence of chronic obstructive pulmonary disease (COPD) in atrial fibrillation (AF) patients is unclear, and its association with adverse outcomes is often overlooked. Our aim was to estimate the prevalence of COPD, its impact on clinical management and outcomes in patients with AF, and the impact of beta-blockers (BBs) on outcomes in patients with COPD.

2021 - Prevention of long-lasting atrial fibrillation through antitachycardia pacing in DDDR pacemakers [Articolo su rivista]
Boriani, G.; Sakamoto, Y.; Botto, G.; Komura, S.; Pieragnoli, P.; Minamiguchi, H.; Iacopino, S.; Noma, T.; Infusino, T.; Takahashi, Y.; Facchin, D.; De Rosa, F.; Pisano, E.; Meloni, S.; Biffi, M.
abstract

Objective: The MINERVA trial showed that in pacemaker patients with atrial fibrillation (AF) history, DDDRP pacing combining three algorithms – (a) atrial antitachycardia pacing with Reactive ATP enabled, (b) atrial preventive pacing and (c) managed ventricular pacing (MVP)—may effectively delay progression to persistent/permanent AF compared with standard DDDR pacing. We performed a comparative non-randomised evaluation to evaluate if Reactive ATP can be the main driver of persistent/permanent AF reduction independently on preventive pacing. Methods: Thirty-one centres included consecutive dual-chamber pacemaker patients with AF history. Reactive ATP was programmed in all patients while preventive atrial pacing was not enabled. These patients were compared with the three groups of MINERVA randomised trial (Control DDDR, MVP, and DDDRP). The main endpoint was the incidence of AF longer than 7 consecutive days. Results: A total of 146 patients (73 years old, 54% male) were included and followed for a median observation period of 31 months. The 2-year incidence of AF > 7 days was 12% in the Reactive ATP group, very similar to that found in the DDDRP arm of the MINERVA trial (13.8%, P =.732) and significantly lower than AF incidence found in the MINERVA Control DDDR arm (25.8%, P =.012) and in the MINERVA MVP arm (25.9%, P =.025). Conclusions: In a real-world population of dual-chamber pacemaker patients with AF history, the use of Reactive ATP is associated with a low incidence of persistent AF, highlighting that the positive results of the MINERVA trial were related to the effectiveness of Reactive ATP rather than to preventive pacing.

2021 - Procedural complications in patients undergoing catheter ablation for atrial fibrillation: Let's talk about sex [Articolo su rivista]
Imberti, Jacopo Francesco; Boriani, Giuseppe; Gupta, Dhiraj; Lip, Gregory Y H
abstract

2021 - Prognostic value of implantable defibrillator-computed respiratory disturbance index: The DASAP-HF study [Articolo su rivista]
Boriani, Giuseppe; Pisanò, Ennio C L; Pieragnoli, Paolo; Locatelli, Alessandro; Capucci, Alessandro; Talarico, Antonello; Zecchin, Massimo; Rapacciuolo, Antonio; Piacenti, Marcello; Indolfi, Ciro; Arias, Miguel Angel; Diemberger, Igor; Checchinato, Catia; La Rovere, Maria Teresa; Sinagra, Gianfranco; Emdin, Michele; Ricci, Renato Pietro; D'Onofrio, Antonio
abstract

Sleep apnea, as measured by polysomnography, is associated with adverse outcomes in heart failure. The DASAP-HF (Diagnosis and Treatment of Sleep Apnea in Patient With Heart Failure) study previously demonstrated that the respiratory disturbance index (RDI) computed by the ApneaScan algorithm (Boston Scientific) accurately identifies severe sleep apnea in implantable cardioverter-defibrillator (ICD) patients.

2021 - Red blood cell distribution width in patients undergoing transcatheter aortic valve implantation: Implications for outcomes [Articolo su rivista]
Valenti, A. C.; Vitolo, M.; Manicardi, M.; Arrotti, S.; Magnavacchi, P.; Gabbieri, D.; Tondi, S.; Guiducci, V.; Losi, L.; Vignali, L.; Sgura, F. A.; Boriani, G.
abstract

Background: Red cell distribution width (RDW) is recently emerging as a prognostic indicator in many cardiovascular diseases. However, less is known about its predictive role in patients undergoing transcatheter aortic valve implantation (TAVI). Methods: We retrospectively included very high-risk patients with severe aortic valve stenosis undergoing TAVI between February 2012 and December 2019. Patients were classified according to RDW tertiles. Our primary endpoint was long-term all-cause mortality. The secondary endpoint was a composite of in-hospital major adverse events as defined by the Valve Academic Research Consortium 2 criteria and/or long-term all-cause mortality. Results: A total of 424 patients [median age 83.5 years, 52.6% females] were analysed. After a median follow-up of 1.55 years, all-cause mortality was 25.5%. At the multivariate-adjusted Cox regression analysis, patients in the highest RDW tertile were associated with a higher risk for all-cause mortality [hazard ratio [HR] 1.73, 95%confidence interval [CI] 1.02-2.95] compared with the lowest tertile. When considering RDW as a continuous variable, we found an 11% increased risk in overall mortality [HR 1.11, 95% CI 1.00-1.24] for each increased point in RDW. The highest RDW tertile was also independently associated with the occurrence of the composite endpoint [odds ratio [OR] 2.10, 95% CI 1.17-3.76] compared with lower tertiles. Conclusions: In our cohort, elevated basal RDW values were independent predictors of increased long-term mortality and higher rate of in-hospital adverse events. The inclusion of a routinely available biomarker as RDW, may help the pre-operative risk assessment in potential TAVI candidates and optimise their management.

2021 - Red cell distribution width and patient outcome in cardiovascular disease: A ‘’real-world” analysis [Articolo su rivista]
Talarico, M.; Manicardi, M.; Vitolo, M.; Malavasi, V. L.; Valenti, A. C.; Sgreccia, D.; Rossi, R.; Boriani, G.
abstract

Red cell distribution width (RDW) has been shown to predict adverse outcomes in specific scenarios. We aimed to assess the association between RDW and all-cause death and a clinically relevant composite endpoint in a population with various clinical manifestations of cardiovascular diseases. We retrospectively analyzed 700 patients (median age 72.7 years [interquartile range, IQR, 62.6–80]) admitted to the Cardiology ward between January and November 2016. Patients were divided into tertiles according to baseline RDW values. After a median follow-up of 3.78 years (IQR 3.38–4.03), 153 (21.9%) patients died and 247 (35.3%) developed a composite endpoint (all-cause death, acute coronary syndromes, transient ischemic attack/stroke, and/or thromboembolic events). With multivariate Cox regression analysis, the highest RDW tertile was independently associated with an increased risk of all-cause death (adjusted hazard ratio [HR] 2.73, 95% confidence interval [CI] 1.63–4.56) and of the composite endpoint (adjusted HR 2.23, 95% CI 1.53–3.24). RDW showed a good predictive ability for all-cause death (C-statistics: 0.741, 95% CI 0.694–0.788). In a real-world cohort of patients, we found that higher RDW values were independently associated with an increased risk of all-cause death and clinical adverse cardiovascular events thus proposing RDW as a prognostic marker in cardiovascular patients.

2021 - Red cell distribution width: a routinely available biomarker with important clinical implications in patients with atrial fibrillation [Articolo su rivista]
Valenti, Anna Chiara; Vitolo, Marco; Imberti, Jacopo Francesco; Malavasi, Vincenzo Livio; Boriani, Giuseppe
abstract

2021 - Registro Italiano Ablazioni 2019. Associazione Italiana di Aritmologia e Cardiostimolazione [Articolo su rivista]
Stabile, Giuseppe; Guerra, Federico; Tola, Gianfranco; Bertaglia, Emanuele; Palmisano, Pietro; Berisso, Massimo Zoni; Soldati, Ezio; Bisignani, Giovanni; Forleo, Giovanni Battista; Zanotto, Gabriele; Landolina, Maurizio; Boriani, Giuseppe; D'Onofrio, Antonio; De Ponti, Roberto; Ricci, Renato Pietro
abstract

Background: This report describes the findings of the 2019 Italian Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC). Methods: Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers. Results: A total of 15 201 ablation procedures were performed by 91 institutions. Most (78%) of the centers has one electrophysiology laboratory, and 17% of them has a hybrid cardiac surgery laboratory. Almost all (98%) centers have a 3D mapping system. The median number of electrophysiologists and nurses involved in the electrophysiology laboratory was 3 and an electrophysiology technician was involved in 30% of all centers. In 88.4% of cases, ablations were performed for supraventricular arrhythmias, and among these the most frequently treated arrhythmia was atrial fibrillation (32.9%), followed by atrioventricular nodal reentrant tachycardia (23.9%), and common atrial flutter (11.7%). In 10 256 (67.4%) patients catheter ablation was performed by means of a 3D mapping system, with a "near-zero" fluoroscopic approach in 4626 (30.4%) of all patients. Conclusions: The 2019 Italian Catheter Ablation Registry confirmed that atrial fibrillation is the most commonly treated arrhythmia in the ablation centers with an increasing number of procedures performed with a 3D mapping system and a "near-zero" approach.

2021 - Relation of outcomes to ABC (Atrial Fibrillation Better Care) pathway adherent care in European patients with atrial fibrillation: an analysis from the ESC-EHRA EORP Atrial Fibrillation General Long-Term (AFGen LT) Registry [Articolo su rivista]
Proietti, Marco; Lip, Gregory Y H; Laroche, Cécile; Fauchier, Laurent; Marin, Francisco; Nabauer, Michael; Potpara, Tatjana; Dan, Gheorghe-Andrei; Kalarus, Zbigniew; Tavazzi, Luigi; Maggioni, Aldo Pietro; Boriani, Giuseppe
abstract

There has been an increasing focus on integrated, multidisciplinary, and holistic care in the treatment of atrial fibrillation (AF). The 'Atrial Fibrillation Better Care' (ABC) pathway has been proposed to streamline integrated care in AF. We evaluated the impact on outcomes of an ABC adherent management in a contemporary real-life European-wide AF cohort.

2021 - Remote monitoring and telemedicine in heart failure: implementation and benefits [Articolo su rivista]
Imberti, J. F.; Tosetti, A.; Mei, D. A.; Maisano, A.; Boriani, G.
abstract

Purpose of review: Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) is recommended as part of the individualized multidisciplinary follow-up of heart failure (HF) patients. Aim of this article is to critically review recent findings on RM, highlighting potential benefits and barriers to its implementation. Recent findings: Device-based RM is useful in the early detection of CIEDs technical issues and cardiac arrhythmias. Moreover, RM allows the continuous monitoring of several patients' clinical parameters associated with impending HF decompensation, but there is still uncertainty regarding its effectiveness in reducing mortality and hospitalizations. Summary: Implementation of RM strategies, together with a proactive physicians' attitude towards clinical actions in response to RM data reception, will make RM a more valuable tool, potentially leading to better outcomes.

2021 - Reshaping of italian echocardiographic laboratories activities during the second wave of covid-19 pandemic and expectations for the post-pandemic era [Articolo su rivista]
Ciampi, Q.; Antonini-Canterin, F.; Barbieri, A.; Barchitta, A.; Benedetto, F.; Cresti, A.; Miceli, S.; Monte, I.; Petrella, L.; Trocino, G.; Aquila, I.; Barbati, G.; Barletta, V.; Barone, D.; Beraldi, M.; Bergandi, G.; Bilardo, G.; Boriani, G.; Bossone, E.; Bongarzoni, A.; Bovolato, F. E.; Bursi, F.; Cammalleri, V.; Carbonella, M.; Casavecchia, G.; Cicco, S.; Cioffi, G.; Cocchia, R.; Colonna, P.; Cortigiani, L.; Cucchini, U.; D'Alfonso, M. G.; D'Andrea, A.; Dell'Angela, L.; Dentamaro, I.; De Paolis, M.; De Stefanis, P.; Deste, W.; Di Fulvio, M.; Di Giannuario, G.; Di Lisi, D.; Di Nora, C.; Fabiani, I.; Esposito, R.; Fazzari, F.; Ferrara, L.; Filice, G.; Forno, D.; Giorgi, M.; Giustiniano, E.; Greco, C. A.; Iannuzzi, G. L.; Izzo, A.; Lanzone, A. M.; Malagoli, A.; Mantovani, F.; Manuppelli, V.; Mega, S.; Merli, E.; Ministeri, M.; Morrone, D.; Napoletano, C.; Nunziata, L.; Pastorini, G.; Pedone, C.; Petruccelli, E.; Polito, M. V.; Polizzi, V.; Prota, C.; Rigo, F.; Rivaben, D. E.; Saponara, S.; Sciacqua, A.; Sartori, C.; Scarabeo, V.; Serra, W.; Severino, S.; Spinelli, L.; Tamborini, G.; Tota, A.; Villari, B.; Carerj, S.; Picano, E.; Pepi, M.
abstract

Background: Cardiology divisions reshaped their activities during the coronavirus disease 2019 (COVID-19) pandemic. This study aimed to analyze the organization of echocardiographic laboratories and echocardiography practice during the second wave of the COVID-19 pandemic in Italy, and the expectations for the post-COVID era. Methods: We analyzed two different time periods: the month of November during the second wave of the COVID-19 pandemic (2020) and the identical month during 2019 (November 2019). Results: During the second wave of the COVID-19 pandemic, the hospital activity was partially reduced in 42 (60%) and wholly interrupted in 3 (4%) echocardiographic laboratories, whereas outpatient echocardiographic activity was partially reduced in 41 (59%) and completely interrupted in 7 (10%) laboratories. We observed an important change in the organization of activities in the echocardiography laboratory which reduced the operator-risk and improved self-protection of operators by using appropriate personal protection equipment. Operators wore FFP2 in 58 centers (83%) during trans-thoracic echocardiography (TTE), in 65 centers (93%) during transesophageal echocardiography (TEE) and 63 centers (90%) during stress echocardiography. The second wave caused a significant reduction in number of echocardiographic exams, compared to November 2019 (from 513 ± 539 to 341 ± 299 exams per center, −34%, p < 0.001). On average, there was a significant increase in the outpatient waiting list for elective echocardiographic exams (from 32.0 ± 28.1 to 45.5 ± 44.9 days, +41%, p < 0.001), with a reduction of in-hospital waiting list (2.9 ± 2.4 to 2.4 ± 2.0 days, −17%, p < 0.001). We observed a large diffusion of point-of-care cardiac ultrasound (88%), with a significant increase of lung ultrasound usage in 30 centers (43%) during 2019, extended to all centers in 2020. Carbon dioxide production by examination is an indicator of the environmental impact of technology (100-fold less with echocardiography compared to other cardiac imaging techniques). It was ignored in 2019 by 100% of centers, and currently it is considered potentially crucial for decision-making in cardiac imaging by 65 centers (93%). Conclusions: In one year, major changes occurred in echocardiography practice and culture. The examination structure changed with extensive usage of point-of-care cardiac ultrasound and with lung ultrasound embedded by default in the TTE examination, as well as the COVID-19 testing.

2021 - Role of cardiac imaging in patients undergoing catheter ablation of ventricular tachycardia [Articolo su rivista]
Muser, Daniele; Lavalle, Carlo; Guarracini, Fabrizio; Sassone, Biagio; Conte, Edoardo; Magnani, Silavia; Notarstefano, Pasquale; Barbato, Gaetano; Sgarito, Giuseppe; Grandinetti, Giuseppe; Nucifora, Gaetano; Ricci, Renato P; Boriani, Giuseppe; De Ponti, Roberto; Casella, Michela
abstract

: Ventricular tachycardia is a major health issue in patients with structural heart disease (SHD). Implantable cardioverter defibrillator (ICD) therapy has significantly reduced the risk of sudden cardiac death (SCD) in such patients, but on the other hand, it has led to frequent ICD shocks as an emerging problem, being associated with poor quality of life, frequent hospitalizations and increased mortality. Myocardial scar plays a central role in the genesis and maintenance of re-entrant arrhythmias, as the coexistence of surviving myocardial fibres within fibrotic tissue leads to the formation of slow conduction pathways and to a dispersion of activation and refractoriness that constitutes the milieu for ventricular tachycardia circuits. Catheter ablation has repeatedly proven to be well tolerated and highly effective in treating VT and in the last two decades has benefited from continuous efforts to determine ventricular tachycardia mechanisms by integration with a wide range of invasive and noninvasive imaging techniques such as intracardiac echocardiography, cardiac magnetic resonance, multidetector computed tomography and nuclear imaging. Cardiovascular imaging has become a fundamental aid in planning and guiding catheter ablation procedures by integrating structural and electrophysiological information, enabling the ventricular tachycardia arrhythmogenic substrate to be characterized and effective ablation targets to be identified with increasing precision, and allowing the development of new ablation strategies with improved outcomes. In this review, we provide an overview of the role of cardiac imaging in patients undergoing catheter ablation of ventricular tachycardia.

2021 - Screening for Atrial Fibrillation in Relation to Stroke and Mortality Risk [Articolo su rivista]
Proietti, M.; Boriani, G.
abstract

2021 - Seventeen-year trend (2001–2017) in pacemaker and implantable cardioverter-defibrillator utilization based on hospital discharge database data: An analysis by age groups [Articolo su rivista]
Zecchin, M.; Torre, M.; Carrani, E.; Sampaolo, L.; Ciminello, E.; Ortis, B.; Ricci, R.; Proclemer, A.; Sinagra, G.; Boriani, G.
abstract

Aims: To analyze temporal trends (2001 -2017) of Pacemakers (PM) and Implantable Cardioverter-Defibrillators (ICD) procedures in Italy, according to the national Hospital Discharge Database (HDD). Methods: Frequency and implant rate (IR) in the Italian population were analyzed by age groups (<50, 50–79, ≥80 years). Results: From 2001 (2009 for Cardiac Resynchronization Therapy-Defibrillator – CRT-D) to 2017, first PM implants (1stPM) increased from 36,823 (637/million inhabitants) to 49,716 (820/million), ICD implants from 3,141 (54/million) to 24,255 (400/million) and CRT-D from 2,915 (49/million, 16.5% of ICD) to 8,595 (142/million, 35.4% of ICD). ICD implants due to ventricular tachycardia or ventricular fibrillation decreased from 55.6% to 13.5% and from 15.9% to 4.5% respectively, while the proportion increased among patients with heart failure (from 22.9% to 46.8%), hypertension (from 11.1% to 15.0%), diabetes (from 6.5% to 10.9%), and renal insufficiency (from 4.4% to 7.6%). Both PM and ICD procedures markedly increased in patients ≥80 years old. However, while IR for ICDs increased from 82/million to 1,038/million inhabitants, IR of 1stPM only changed from 6,111/million to 6,212/million as the population in this age group nearly doubled in Italy. Conclusion: Since 2001, the increase of 1stPM in Italy was mainly due to the ultra-octogenarian population growth. No differences were observed for IR in each PM age group, while the absolute number and IR increased in all groups (especially ≥80 years old) for ICDs and CRT-Ds. An increase in comorbidities and a reduction in implants for secondary prevention were observed in the ICD population.

2021 - Sinergy between drugs and devices in the fight against sudden cardiac death and heart failure [Articolo su rivista]
Boriani, G.; De Ponti, R.; Guerra, F.; Palmisano, P.; Zanotto, G.; D'Onofrio, A.; Ricci, R. P.
abstract

The impact of sudden cardiac death (SCD) in heart failure (HF) patients is important and prevention of SCD is a reasonable and clinically justified endpoint if associated with a reduction in all-cause mortality. According to literature, in HF with reduced ejection fraction, only three classes of agents were found effective in reducing SCD and all-cause mortality: beta-blockers, mineralcorticoid receptor antagonists and, more recently, angiotensin-receptor neprilysin-inhibitors. In the PARADIGM trial that tested sacubitril/valsartan vs. enalapril, the 20% relative risk reduction in cardiovascular deaths obtained with sacubitril/valsartan was attributable to reductions in the incidence of both SCD and death due to HF worsening and this effect can be added to the known positive effect of implantable cardioverter-defibrillators in appropriately selected patients. In order to maximize the implementation of all the available treatments, patients with HF should be included in virtuous networks with a dialogue between all the physician involved, with commitment by all these physicians for appropriate decision-making on application of pharmacological and device treatments according to available evidence, as well as commitment for drug titration before and after device implant, taking advantage from remote monitoring, and with the safety of back up device therapy when indicated. There are potential synergistic effects of drug therapy, with all the therapies acting on neuro-hormonal and sympathetic activation, but specifically with sacubitril/valsartan, and device therapy, in particular cardiac resynchronization therapy, with added incremental benefits on positive cardiac remodelling, prevention of HF progression, and prevention of ventricular tachyarrhythmias.

2021 - Sudden cardiac death in dialysis patients: different causes and management strategies [Articolo su rivista]
Genovesi, Simonetta; Boriani, Giuseppe; Covic, Adrian; Vernooij, Robin W M; Combe, Christian; Burlacu, Alexandru; Davenport, Andrew; Kanbay, Mehmet; Kirmizis, Dimitrios; Schneditz, Daniel; van der Sande, Frank; Basile, Carlo
abstract

Sudden cardiac death (SCD) represents a major cause of death in end-stage kidney disease (ESKD). The precise estimate of its incidence is difficult to establish because studies on the incidence of SCD in ESKD are often combined with those related to sudden cardiac arrest (SCA) occurring during a haemodialysis (HD) session. The aim of the European Dialysis Working Group of ERA-EDTA was to critically review the current literature examining the causes of extradialysis SCD and intradialysis SCA in ESKD patients and potential management strategies to reduce the incidence of such events. Extradialysis SCD and intradialysis SCA represent different clinical situations and should be kept distinct. Regarding the problem, numerically less relevant, of patients affected by intradialysis SCA, some modifiable risk factors have been identified, such as a low concentration of potassium and calcium in the dialysate, and some advantages linked to the presence of automated external defibrillators in dialysis units have been documented. The problem of extra-dialysis SCD is more complex. A reduced left ventricular ejection fraction associated with SCD is present only in a minority of cases occurring in HD patients. This is the proof that SCD occurring in ESKD has different characteristics compared with SCD occurring in patients with ischaemic heart disease and/or heart failure and not affected by ESKD. Recent evidence suggests that the fatal arrhythmia in this population may be due more frequently to bradyarrhythmias than to tachyarrhythmias. This fact may partly explain why several studies could not demonstrate an advantage of implantable cardioverter defibrillators in preventing SCD in ESKD patients. Electrolyte imbalances, frequently present in HD patients, could explain part of the arrhythmic phenomena, as suggested by the relationship between SCD and timing of the HD session. However, the high incidence of SCD in patients on peritoneal dialysis suggests that other risk factors due to cardiac comorbidities and uraemia per se may contribute to sudden mortality in ESKD patients.

2021 - The 4S-AF scheme (Stroke Risk; Symptoms; Severity of Burden; Substrate): A novel approach to in-depth characterization (rather than classification) of atrial fibrillation [Articolo su rivista]
Potpara, T. S.; Lip, G. Y. H.; Blomstrom-Lundqvist, C.; Boriani, G.; Van Gelder, I. C.; Heidbuchel, H.; Hindricks, G.; Camm, A. J.
abstract

Atrial fibrillation (AF) is a complex condition requiring holistic management with multiple treatment decisions about optimal thromboprophylaxis, symptom control (and prevention of AF progression), and identification and management of concomitant cardiovascular risk factors and comorbidity. Sometimes the information needed for treatment decisions is incomplete, as available classifications of AF mostly address a single domain of AF (or patient)-related characteristics. The most widely used classification of AF based on AF episode duration and temporal patterns (that is, the classification to first-diagnosed, paroxysmal, persistent/long-standing persistent, and permanent AF) has contributed to a better understanding of AF prevention and treatment but its limitations and the need for a multidimensional AF classification have been recognized as more complex treatment options became available. We propose a paradigm shift from classification toward a structured characterization of AF, addressing specific domains having treatment and prognostic implications to become a standard in clinical practice, thus aiming to streamline the assessment of AF patients at all health care levels facilitating communication among physicians, treatment decision-making, and optimal risk evaluation and management of AF patients. Specifically, we propose the 4S-AF structured pathophysiology-based characterization (rather than classification) scheme that includes four AF- and patient-related domains-Stroke risk, Symptoms, Severity of AF burden, and Substrate severity-and provide a hypothetical model for the use of 4S-AF characterization scheme to aid treatment decision making concerning the management of patients with AF in clinical practice.

2021 - The challenge to improve knowledge on the interplay between subclinical atrial fibrillation, atrial cardiomyopathy, and atrial remodeling [Articolo su rivista]
Boriani, G.; Imberti, J. F.; Vitolo, M.
abstract

2021 - The impact of covid-19 pandemic and lockdown restrictions on cardiac implantable device recipients with remote monitoring [Articolo su rivista]
Diemberger, I.; Vicentini, A.; Cattafi, G.; Ziacchi, M.; Iacopino, S.; Morani, G.; Pisano, E.; Molon, G.; Giovannini, T.; Russo, A. D.; Boriani, G.; Bertaglia, E.; Biffi, M.; Bongiorni, M. G.; Rordorf, R.; Zucchelli, G.
abstract

From 2020, many countries have adopted several restrictions to limit the COVID-19 pandemic. The forced containment impacted on healthcare organizations and the everyday life of patients with heart disease. We prospectively analyzed data recorded from implantable defibrillators and/or cardiac resynchronization devices of Italian patients during the lockdown (LDP), post-lockdown period (PLDP) and a control period (CP) of the previous year. We analyzed device data of the period 9 March 2019–31 May 2020 of remotely monitored patients from 34 Italian centers. Patients were also categorized according to areas with high/low infection prevalence. Among 696 patients, we observed a significant drop in median activity in LDP as compared to CP that significantly increased in the PLDP, but well below CP (all p < 0.0001). The median day heart rate and heart rate variability showed a similar trend. This behavior was associated during LDP with a significant increase in the burden of atrial arrhythmias (p = 0.0150 versus CP) and of ventricular arrhythmias [6.6 vs. 1.5 per 100 patient-weeks in CP; p = 0.0026]; the latter decreased in PLDP [0.3 per 100 patient-weeks; p = 0.0035 vs. LDP]. No modifications were recorded in thoracic fluid levels. The high/low prevalence of COVID-19 infection had no significant impact. We found an increase in the arrhythmic burden in LDP coupled with a decrease in physical activity and heart rate variability, without significant modifications of transthoracic impedance, independent from COVID-19 infection prevalence. These findings suggest a negative impact of the COVID-19 pandemic, probably related to lockdown restrictions.

2021 - The importance of adherence and persistence with oral anticoagulation treatment in patients with atrial fibrillation [Articolo su rivista]
Lip, Gregory Y H; Boriani, Giuseppe; Lane, Deirdre A; Vitolo, Marco
abstract

2021 - The practice of deep sedation in electrophysiology and cardiac pacing laboratories: Results of an italian survey promoted by the aiac (italian association of arrhythmology and cardiac pacing) [Articolo su rivista]
Palmisano, P.; Ziacchi, M.; Angeletti, A.; Guerra, F.; Forleo, G. B.; Bertini, M.; Notarstefano, P.; Accogli, M.; Lavalle, C.; Bisignani, G.; Landolina, M.; Zanotto, G.; D'Onofrio, A.; Ricci, R. P.; De Ponti, R.; Boriani, G.
abstract

The aim of this survey, which was open to all Italian cardiologists involved in arrhythmia, was to assess common practice regarding sedation and analgesia in interventional electrophysiology procedures in Italy. The survey consisted of 28 questions regarding the approach to sedation used for elective direct-current cardioversion (DCC), subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation, atrial fibrillation (AF) ablation, ventricular tachycardia (VT) ablation, and transvenous lead extraction procedures. A total of 105 cardiologists from 92 Italian centres took part in the survey. The rate of centres where DCC, S-ICD implantation, AF ablation, VT ablation and lead extraction procedures were performed without anaesthesiologic assistance was 60.9%, 23.6%, 51.2%, 37.3%, and 66.7%, respectively. When these procedures were performed without anaesthesiologic assistance, the drugs (in addition to local anaesthetics) commonly administered were benzodiazepines (from 64.3% to 79.6%), opioids (from 74.4% to 88.1%), and general anaesthetics (from 7.1% to 30.4%). Twenty-three (21.9%) of the 105 cardiologists declared that they routinely administered propofol, without the supervision of an anaesthesiologist, in at least one of the above-mentioned procedures. In current Italian clinical practice, there is a lack of uniformity in the sedation/analgesia approach used in interventional electrophysiology procedures.

2021 - Trans-catheter valve implantation and patient outcomes: Focus on the kidney [Articolo su rivista]
Boriani, G.; Arrotti, S.; Gabbieri, D.; Magnavacchi, P.; Sgura, F. A.
abstract

2021 - Updating a simple clinical score predicting incident atrial fibrillation: The C2HEST score or more (mC2HEST)? [Articolo su rivista]
Imberti, J. F.; Boriani, G.; Lip, G. Y. H.
abstract

2021 - Worldwide Survey of COVID-19 Associated Arrhythmias [Articolo su rivista]
Coromilas, Ellie J; Kochav, Stephanie; Goldenthal, Isaac; Biviano, Angelo; Garan, Hasan; Goldbarg, Seth; Kim, Joon-Hyuk; Yeo, Ilhwan; Tracy, Cynthia; Ayanian, Shant; Akar, Joseph; Singh, Avinainder; Jain, Shashank; Zimerman, Leandro; Pimentel, Maurício; Osswald, Stefan; Twerenbold, Raphael; Schaerli, Nicolas; Crotti, Lia; Fabbri, Daniele; Parati, Gianfranco; Li, Yi; Atienza, Felipe; Zatarain, Eduardo; Tse, Gary; Leung, Keith Sai Kit; Guevara-Valdivia, Milton E; Rivera-Santiago, Carlos A; Soejima, Kyoko; De Filippo, Paolo; Ferrari, Paola; Malanchini, Giovanni; Kanagaratnam, Prapa; Khawaja, Saud; Mikhail, Ghada W; Scanavacca, Mauricio; Hajjar, Ludhmila Abrahão; Rizerio Gomes, Brenno; Sacilotto, Luciana; Mollazadeh, Reza; Eslami, Masoud; Laleh Far, Vahideh; Mattioli, Anna Vittoria; Boriani, Giuseppe; Migliore, Federico; Cipriani, Alberto; Donato, Filippo; Compagnucci, Paolo; Casella, Michela; Dello Russo, Antonio; Coromilas, James; Aboyme, Andrew; O'Brien, Connor Galen; Rodriguez, Fatima; Wang, Paul J; Naniwadekar, Aditi; Moey, Melissa; Know, Chia Siang; Cheah, Wee Kooi; Auricchio, Angelo; Conte, Giulio; Hwang, Jongmin; Han, Seongwook; Lazzerini, Pietro Enea; Franchi, Federico; Santoro, Amato; Capecchi, Pier Leopoldo; Joglar, Jose A; Rosenblatt, Anna G; Zardini, Marco; Bricoli, Serena; Bonura, Rosario; Echarte-Morales, Julio; Benito-González, Tomás; Minguito-Carazo, Carlos; Fernández-Vázquez, Felipe; Wan, Elaine Y
abstract

Background - COVID-19 has led to over 1 million deaths worldwide and has been associated with cardiac complications including cardiac arrhythmias. The incidence and pathophysiology of these manifestations remain elusive. In this worldwide survey of patients hospitalized with COVID-19 who developed cardiac arrhythmias, we describe clinical characteristics associated with various arrhythmias, as well as global differences in modulations of routine electrophysiology practice during the pandemic. Methods - We conducted a retrospective analysis of patients hospitalized with COVID-19 infection worldwide with and without incident cardiac arrhythmias. Patients with documented atrial fibrillation (AF), atrial flutter (AFL), supraventricular tachycardia (SVT), non-sustained or sustained ventricular tachycardia (VT), ventricular fibrillation (VF), atrioventricular block (AVB), or marked sinus bradycardia (HR<40bpm) were classified as having arrhythmia. De-identified data was provided by each institution and analyzed. Results - Data was collected for 4,526 patients across 4 continents and 12 countries, 827 of whom had an arrhythmia. Cardiac comorbidities were common in patients with arrhythmia: 69% had hypertension, 42% diabetes mellitus, 30% had heart failure and 24% coronary artery disease. Most had no prior history of arrhythmia. Of those who did develop an arrhythmia, the majority (81.8%) developed atrial arrhythmias, 20.7% developed ventricular arrhythmias, and 22.6% had bradyarrhythmia. Regional differences suggested a lower incidence of AF in Asia compared to other continents (34% vs. 63%). Most patients in in North America and Europe received hydroxychloroquine, though the frequency of hydroxychloroquine therapy was constant across arrhythmia types. Forty-three percent of patients who developed arrhythmia were mechanically ventilated and 51% survived to hospital discharge. Many institutions reported drastic decreases in electrophysiology procedures performed. Conclusions - Cardiac arrhythmias are common and associated with high morbidity and mortality among patients hospitalized with COVID-19 infection. There were significant regional variations in the types of arrhythmias and treatment approaches.

2020 - A giant right coronary artero-venous fistula revealed by an integrated multimodality imaging approach [Articolo su rivista]
Denegri, A.; Albini, A.; Barbieri, A.; Boriani, G.
abstract

2020 - AB0611 STRAIN ANALYSIS OF THE RIGHT VENTRICLE USING 2D-SPECKLE TRACKING ECHOCARDIOGRAPHY IN A COHORT OF PATIENTS WITH SYSTEMIC SCLEROSIS [Abstract in Rivista]
Spinella, A; Macripo, P; Cocchiara, E; Galli, E; Lumetti, F; Magnani, L; Coppi, F; Mattioli, Av; Rossi, R; Boriani, G; Salvarani, C; Giuggioli, D
abstract

Background: Systemic Sclerosis (SSc) is a rare and life-threatening connective tissue disease with multiple organ impairment. Cardio-pulmonary involvement is common: pulmonary fibrosis, pulmonary hypertension (PH), and electrical disorders are the most serious complications and causes of increased mortality. Objectives: We evaluated features related with the onset and development of PH in a cohort of SSc patients. We further studied ecocardiographic abnormalities, by means of 2D-speckle tracking echocardiography (STE) with specific reference to the right ventricular strain measure (RV-strain). Methods: We analyzed data from 50 SSc patients (pts) referred to our University-based Rheumatology Centre and SSc Unit from January 2007 to June 2019 (F/M 45/5; lc/dcSSc 45/5; mean age 59.20±14.357 years; mean disease duration 12.08±8.75 years). All pts underwent general and cardio-pulmonary …

2020 - Anticoagulation to prevent ischemic stroke in patients with atrial fibrillation: a complex scenario including underdiagnosis, undertreatment or underdosing of oral anticoagulants [Articolo su rivista]
Boriani, Giuseppe; Imberti, Jacopo F; Vitolo, Marco
abstract

2020 - Antithrombotic treatment in atrial fibrillation patients undergoing percutaneous coronary interventions: focus on stent thrombosis [Articolo su rivista]
Vitolo, Marco; Javed, Saad; Capodanno, Davide; Rubboli, Andrea; Boriani, Giuseppe; Lip, Gregory Y H
abstract

Coronary artery disease (CAD) commonly coexists with atrial fibrillation (AF), requiring oral anticoagulation (OAC) in a significant subset of patients. These patients also often require revascularization with percutaneous coronary intervention (PCI), which traditionally is supported with dual antiplatelet therapy (DAPT) to prevent complications including stent thrombosis (ST). Recent clinical studies have demonstrated that dual therapy (DAT, i.e. OAC plus single P2Y12 inhibitor) has a more favorable safety profile than triple antithrombotic therapy (TAT). As none of these trials were sufficiently powered for evaluating ischemic outcomes, some concerns remain regarding ischemic complications, in particular ST, a catastrophic complication of PCI.

2020 - Are atrial high rate episodes (AHREs) a precursor to atrial fibrillation? [Articolo su rivista]
Khan, A. A.; Boriani, G.; Lip, G. Y. H.
abstract

Abstract: Atrial high rate episodes (AHREs), also termed, subclinical atrial tachyarrhythmias or subclinical atrial fibrillation (AF) are an important cardiovascular condition. Advancement in implantable cardiac devices such as pacemakers or internal cardiac defibrillators has enabled the continuous assessment of atrial tachyarrhythmias in patients with an atrial lead. Patients with device-detected AHREs are at an elevated risk of stroke and may have unmet anticoagulation needs. While the benefits of oral anticoagulation for stroke prevention in patients with clinical AF are well recognised, it is not known whether the same risk–benefit ratio exists for anticoagulation therapy in patients with AHREs. The occurrence and significance of AHRE are increasingly acknowledged but these events are still not often acted upon in patients presenting with stroke and TIA. Additionally, patients with AHRE show a significant risk for major adverse cardiovascular events (MACE) including acute heart failure, myocardial infarction, cardiovascular hospitalisation, ventricular tachycardia/fibrillation, which is dependent on AHRE burden. In this review, we present an overview of this relatively new entity, its associated thromboembolic risk and its management implications. Graphic abstract: [Figure not available: see fulltext.]

2020 - Association between clinical risk scores and mortality in atrial fibrillation: Systematic review and network meta-regression of 669,000 patients [Articolo su rivista]
Proietti, M.; Farcomeni, A.; Romiti, G. F.; Di Rocco, A.; Placentino, F.; Diemberger, I.; Lip, G. Y. H.; Boriani, G.
abstract

Aims: Many clinical scores for risk stratification in patients with atrial fibrillation have been proposed, and some have been useful in predicting all-cause mortality. We aim to analyse the relationship between clinical risk score and all-cause death occurrence in atrial fibrillation patients. Methods: We performed a systematic search in PubMed and Scopus from inception to 22 July 2017. We considered the following scores: ATRIA-Stroke, ATRIA-Bleeding, CHADS2, CHA2DS2-VASc, HAS-BLED, HATCH and ORBIT. Papers reporting data about scores and all-cause death rates were considered. Results: Fifty studies and 71 scores groups were included in the analysis, with 669,217 patients. Data on ATRIA-Bleeding, CHADS2, CHA2DS2-VASc and HAS-BLED were available. All the scores were significantly associated with an increased risk for all-cause death. All the scores showed modest predictive ability at five years (c-indexes (95% confidence interval) CHADS2: 0.64 (0.63–0.65), CHA2DS2-VASc: 0.62 (0.61–0.64), HAS-BLED: 0.62 (0.58–0.66)). Network meta-regression found no significant differences in predictive ability. CHA2DS2-VASc score had consistently high negative predictive value (≥94%) at one, three and five years of follow-up; conversely it showed the highest probability of being the best performing score (63% at one year, 60% at three years, 68% at five years). Conclusion: In atrial fibrillation patients, contemporary clinical risk scores are associated with an increased risk of all-cause death. Use of these scores for death prediction in atrial fibrillation patients could be considered as part of holistic clinical assessment. The CHA2DS2-VASc score had consistently high negative predictive value during follow-up and the highest probability of being the best performing clinical score.

2020 - Atrial fibrillation and remote monitoring through cardiac implantable electronic devices in heart failure patients [Articolo su rivista]
Boriani, G.; Imberti, J. F.; Vitolo, M.
abstract

2020 - Atrial high-rate episodes: clinical significance, prognostic impact and clinical management [Articolo su rivista]
Boriani, G.; Imberti, J. F.; Bonini, N.; Albini, A.; Autieri, A.; Vitolo, M.
abstract

The rapid increase in cardiac implantable electronic device (CIED) implants and their ability to monitor atrial activity significantly contributed to a parallel increase in the occasional detection of atrial tachyarrhythmias, termed as atrial high-rate episodes (AHREs). These episodes of atrial tachyarrhythmia are usually asymptomatic and they are often diagnosed incidentally during the regular follow-up of patients with CIEDs or during the diagnostic work-up for patients affected by cryptogenic stroke. Over the past 20 years, numerous studies attempted to demonstrate the clinical significance and prognostic impact of these episodes, but their clinical management remains unclear. However, AHREs are not only significantly associated with a greater risk of developing clinical atrial fibrillation over time, but are also associated with an increased risk of cerebral and/or systemic thromboembolic events. Therefore, if deemed favorable, the use of oral anticoagulant therapy may be reasonable. The purpose of this review is to perform a state of the art analysis focusing on the clinical management of AHREs, their prognostic impact, the risks and benefits of anticoagulation and the critical issues that have emerged in the last years of studies.

2020 - COVID-19 pandemic: usefulness of telemedicine in management of arrhythmias in elderly people [Articolo su rivista]
Mattioli, Anna Vittoria; Cossarizza, Andrea; Boriani, Giuseppe
abstract

In March 2020, the WHO defined the diffusion of novel coronavirus, Severe Acute Respiratory Syndrome-Coronavirus- 2 (SARS-CoV-2) as pandemic.[13] As a consequence, the Italian Government among others has enforced quarantine on the population to contain the diffusion of the infection.

2020 - Cardiac arrest: The need for integrated multi-disciplinary actions for a continuum of care both in acute and at long-term [Articolo su rivista]
Boriani, G.
abstract

2020 - Cardiac electronic devices: Future directions and challenges [Articolo su rivista]
Kotalczyk, A.; Kalarus, Z.; Wright, D. J.; Boriani, G.; Lip, G. Y. H.
abstract

Cardiovascular implantable electronic devices (CIEDs) are essential management options for patients with brady-and tachyarrhythmias or heart failure with concomitant optimal pharmacotherapy. Despite increasing technological advances, there are still gaps in the management of CIED patients, eg, the growing number of lead-and pocket-related longterm complications, including cardiac device–related infective endocarditis, requires the greatest care. Likewise, patients with CIEDs should be monitored remotely as a part of a comprehensive, holistic management approach. In addition, novel technologies used in smartwatches may be a convenient tool for long-term atrial fibrillation (AF) screening, especially in high-risk populations. Early detection of AF may reduce the risk of stroke and other AF-related complications. The objective of this review article was to provide an overview of novel technologies in cardiac rhythm–management devices and future challenges related to CIEDs.

2020 - Cardiac implantable electrical devices in patients with hypertrophic cardiomyopathy: single center implant data extracted from the Swedish pacemaker and ICD registry [Articolo su rivista]
Valzania, C.; Gadler, F.; Boriani, G.; Rapezzi, C.; Eriksson, M. J.
abstract

Objectives: To investigate cardiac implantable electrical device (CIED) first implants in patients with hypertrophic cardiomyopathy (HCM) in a Swedish tertiary university hospital. Design: Clinical and technical data on pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) first implants performed in HCM patients at the Karolinska University Hospital from 2005 to 2016 were extracted from the Swedish Pacemaker and ICD Registry. Echocardiographic data were obtained by review of hospital recordings. Results: The number of first pacemaker implants in HCM patients was 70 (1.5% of total pacemaker implants). The mean age of HCM pacemaker patients was 71 ± 10 years. Pacemaker implants were almost uniformly distributed between genders. Dual-chamber pacemakers with or without CRT properties were prevalent (6 and 93%, respectively). The number of first ICD implants in HCM patients was 99 (5.1% of total ICD implants). HCM patients receiving an ICD were 53 ± 15 years and prevalently men (70%). Sixty-five (66%) patients were implanted for primary prevention. Dual-chamber ICDs with or without CRT were 21 and 65%, respectively. Obstructive HCM was present in 47% pacemaker patients and 25% ICD patients with available pre-implant echo. Conclusions: This retrospective registry-based study provides a picture of CIED first implants in HCM patients in a Swedish tertiary university hospital. ICDs were the most commonly implanted devices, covering 59% of CIED implants. HCM patients receiving a pacemaker or an ICD had different epidemiological and clinical profiles.

2020 - Cardioversion of recent-onset atrial fibrillation: current evidence, practical considerations, and controversies in a complex clinical scenario [Articolo su rivista]
Boriani, G.; Bonini, N.; Albini, A.; Venturelli, A.; Imberti, J. F.; Vitolo, M.
abstract

Atrial fibrillation (AF) represents the most common arrhythmia and is associated with increased morbidity and mortality generating high social costs. Due to its high prevalence, AF is usually managed not only by cardiologists but also by general practitioners or clinicians in emergency departments. The conventional classification of AF includes "recent‑onset AF" defined as an arrhythmia episode shorter than 48 hours. In patients with a definite duration of AF of less than 24 hours and a very low-risk profile (CHA2DS2VASc of 0 in men and 1 in women), the thromboembolic risk seems to be low, and the standard 4‑week anticoagulation therapy is now regarded as optional treatment. Cardioversion (electrical or pharmacological) in recent‑onset AF represents a valid rhythm control strategy. Electrical cardioversion is usually reserved for hemodynamically unstable patients and performed with biphasic waveform shocks. On the other hand, pharmacological cardioversion is preferred in hemodynamically stable patients. Several antiarrhythmic drugs have been studied so far, but some questions still remain unresolved mainly due to lack of randomized clinical trials and prospective studies. The current guidelines do not uniformly agree on which drug to use for pharmacological cardioversion, and drug preference varies widely in clinical practice. The aim of this narrative review is to sum up and critically evaluate novel evidence regarding recent‑onset AF as well as to provide some practical considerations particularly focused on rhythm control with pharmacological cardioversion.

2020 - Complicated myocardial infarction in a 99-year-old lady in the era of COVID-19 pandemic: from the need to rule out coronavirus infection to emergency percutaneous coronary angioplasty [Articolo su rivista]
Sgura, F. A.; Arrotti, S.; Cappello, C. G.; Boriani, G.
abstract

2020 - Consumer-led screening for atrial fibrillation using consumer-facing wearables, devices and apps: A survey of health care professionals by AF-SCREEN international collaboration [Articolo su rivista]
Boriani, G.; Schnabel, R. B.; Healey, J. S.; Lopes, R. D.; Verbiest-van Gurp, N.; Lobban, T.; Camm, J. A.; Freedman, B.
abstract

Aim: A variety of consumer-facing wearables, devices and apps are marketed directly to consumers to detect atrial fibrillation (AF). However, their management is not defined. Our aim was to explore their role for AF screening via a survey. Methods and Results: An anonymous web-based survey was undertaken by 588 health care professionals (HCPs) (response rate 23.7%). Overall, 57% HCPs currently advise wearables/apps for AF detection in their patients: this was much higher for electrophysiologists and nurses/allied health professionals (74–75%) than cardiologists (57%) or other physicians (34–38%). Approximately 46% recommended handheld (portable) single-lead dedicated ECG devices, or, less frequently, wristband ECG monitors with similar differentials between HCPs. Only 10–15% HCPs advised photoplethysmographic wristband monitors or smartphone apps. In over half of the HCP consultations for AF detected by wearables/apps, the decision to screen was entirely the patient's. About 45% of HCPs perceive a potential role for AF screening in people aged >65 years or in those with risk factors. Almost 70% of HCPs believed we are not yet ready for mass consumer-initiated screening for AF using wearable devices/apps, with patient anxiety, risk of false positives and negatives, and risk of anticoagulant-related bleeding perceived as potential disadvantages, and perceived need for appropriate management pathways. Conclusions: There is a great potential for appropriate use of consumer-facing wearables/apps for AF screening. However, it appears that there is a need to better define suitable individuals for screening and an appropriate mechanism for managing positive results before they can be recommended by HCPs.

2020 - Continuous monitoring of sleep-disordered breathing with pacemakers: Indexes for risk stratification of atrial fibrillation and risk of stroke [Articolo su rivista]
Mazza, A.; Bendini, M. G.; Leggio, M.; De Cristofaro, R.; Valsecchi, S.; Boriani, G.
abstract

Background: Sleep apnea (SA) is a risk factor for atrial fibrillation (AF). Advanced pacemakers are now able to calculate indexes of SA severity. Hypothesis: We investigated the changes in pacemaker-measured indexes of SA, we assessed their predictive value for AF occurrence and the associated risk of stroke and death at long-term. Methods: We enrolled 439 recipients of a pacemaker endowed with an algorithm for the calculation of a Respiratory Disturbance Index (RDI). The RDI variability was measured over the first 12 months after implantation, as well as its potential association with the occurrence of AF, defined as device-detected cumulative AF burden ≥6 hoursours in a day. Results: The individual RDI mean was 30 ± 18 episodes/h, and the RDI maximum was 59 ± 21 episodes/h. RDI ≥30 episodes/h was detected in 351 (80%) patients during at least one night. The proportion of nights with RDI ≥30 episodes/h was 14% (2%-36%). AF ≥6 hours was detected in 129 (29%) patients during the first 12 months. The risk of AF was higher in patients with RDI maximum ≥63 episodes/h (HR:1.74; 95%CI: 1.22-2.48; P =.001) and with RDI mean ≥ 46 episodes/h (HR:1.63; 95%CI: 1.03-2.57; P =.014). The risk of all-cause death or stroke was higher in patients with AF burden ≥6 hours (HR:1.75; 95%CI: 1.06-2.86; P =.016). Moreover, among patients with no previous history of AF the risk was higher in those with RDI maximum ≥63 episodes/h (HR:1.96; 95%CI: 1.06-3.63; P =.031). Conclusions: Pacemaker-detected SA showed a considerable variability during follow-up. We confirmed the association between RDI and higher risk of AF, and we observed an association between higher RDI maximum and all-cause death or stroke among patients with no previous history of AF.

2020 - Cost-effectiveness of an antibacterial envelope for cardiac implantable electronic device infection prevention in the US healthcare system from the WRAP-IT Trial [Articolo su rivista]
Wilkoff, B. L.; Boriani, G.; Mittal, S.; Poole, J. E.; Kennergren, C.; Corey, G. R.; Krahn, A. D.; Schloss, E. J.; Gallastegui, J. L.; Pickett, R. A.; Evonich, R. F.; Roark, S. F.; Sorrentino, D. M.; Sholevar, D. P.; Cronin, E. M.; Berman, B. J.; Riggio, D. W.; Khan, H. H.; Silver, M. T.; Collier, J.; Eldadah, Z.; Holbrook, R.; Lande, J. D.; Lexcen, D. R.; Seshadri, S.; Tarakji, K. G.
abstract

Background: In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system. Methods: A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years were discounted at 3%. An upper willingness-to-pay threshold of $150 000 per quality-adjusted life year was used to determine cost-effectiveness, in alignment with the American College of Cardiology/American Heart Association practice guidelines and as supported by the World Health Organization and contemporary literature. Results: The base case incremental cost-effectiveness ratio of the antibacterial envelope compared with standard-of-care was $112 603/quality-adjusted life year. The incremental cost-effectiveness ratio remained lower than the willingness-to-pay threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost. Conclusions: The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02277990.

2020 - Cytokine Profile in Striated Muscle Laminopathies: New Promising Biomarkers for Disease Prediction [Articolo su rivista]
Cappelletti, Cristina; Tramacere, I.; Cavalcante, P.; Schena, E.; Politano, L.; Carboni, N.; Gambineri, A.; D'Amico, A.; Ruggiero, L.; Ricci, G.; Siciliano, G.; Boriani, G.; Mongini, T. E.; Vercelli, L.; Biagini, E.; Ziacchi, M.; D'Apice, M. R.; Lattanzi, G.; Mantegazza, R.; Maggi, L.; Bernasconi, P.
abstract

Laminopathies are a wide and heterogeneous group of rare human diseases caused by mutations of the LMNA gene or related nuclear envelope genes. The variety of clinical phenotypes and the wide spectrum of histopathological changes among patients carrying an identical mutation in the LMNA gene make the prognostic process rather difficult, and classical genetic screens appear to have limited predictive value for disease development. The aim of this study was to evaluate whether a comprehensive profile of circulating cytokines may be a useful tool to differentiate and stratify disease subgroups, support clinical follow-ups and contribute to new therapeutic approaches. Serum levels of 51 pro- and anti-inflammatory molecules, including cytokines, chemokines and growth factors, were quantified by a Luminex multiple immune-assay in 53 patients with muscular laminopathy (Musc-LMNA), 10 with non-muscular laminopathy, 22 with other muscular disorders and in 35 healthy controls. Interleukin-17 (IL-17), granulocyte colony-stimulating factor (G-CSF) and transforming growth factor beta (TGF-β2) levels significantly discriminated Musc-LMNA from controls; interleukin-1β (IL-1β), interleukin-4 (IL-4) and interleukin-8 (IL-8) were differentially expressed in Musc-LMNA patients compared to those with non-muscular laminopathies, whereas IL-17 was significantly higher in Musc-LMNA patients with muscular and cardiac involvement. These findings support the hypothesis of a key role of the immune system in Musc-LMNA and emphasize the potential use of cytokines as biomarkers for these disorders.

2020 - Degree of left ventricular dilatation at end-diastole: Correlation and prognostic utility of quantitative volumes by 2D-echocardiography versus linear dimensions in patients with asymptomatic aortic regurgitation [Articolo su rivista]
Barbieri, A.; Benfari, G.; Giubertoni, E.; Manicardi, M.; Bursi, F.; Rossi, A.; Maritan, L.; Venturi, G.; Boriani, G.
abstract

Background: Guideline recommendations for aortic valve replacement (AVR) in asymptomatic patients with chronic aortic regurgitation (AR) have historically focused on linear dimensions without normalization for the body surface area (BSA). Values for grading the severity of end-diastolic volume dilatation by 2D echocardiography remain to be established. Methods and Results: We retrospectively analyzed 543 consecutive asymptomatic patients with pure chronic moderate/severe AR (mean age 66 ± 17 years, 37.7% males). Applying the ASE/EACVI guidelines, BSA-indexed LV end-diastolic volume (LVEDVi) and indexed LV end-diastolic diameter (LVEDDi) were assessed. Then, we identified 192 patients with at least mild LV end-diastolic dilatation by volumetric or linear measurements. The outcome endpoint was the combination of cardiac death, hospitalization for acute heart failure or AVR during a median follow-up of 4.5 ± 3.6 years. Multivariable Cox regression analyses including age, LV ejection fraction (EF) and AR severity showed an independent prognostic value of the LVEDDi and LVEDVi (P <.001 and P <.01, respectively). Congruent severe LVEDDi and LVEDVi dilatation was associated with a higher event rate compared to discordant severe LV end-diastolic dilatation or nonsevere LV dilatation (P =.001) even after landmark analysis (P =.02). In patients with EF > 50%, only the LVEDVi showed and independent prognostic value (P <.001). Conclusions: In a cohort of asymptomatic patients with AR, the presence of severe LV volume and diameter dilatation on the basis of the cutoff values proposed by current recommendations and normalized for BSA may be instrumental in the identification of patients at increased risk of clinical progression regardless of EF.

2020 - Driving restriction in patients with cardiac implantable electronic devices: an overview of worldwide regulations [Articolo su rivista]
Imberti, J. F.; Vitolo, M.; Proietti, M.; Diemberger, I.; Ziacchi, M.; Biffi, M.; Boriani, G.
abstract

Introduction: It is common belief that driving with an implantable cardioverter defibrillator (ICD)/pacemaker (PM) might be associated with sudden cardiac incapacitation, road traffic accidents, and chance to harm to self and others. On the other hand, the ability to drive is highly valuable in the modern era, representing a cornerstone of daily living and employment. National regulations try to balance the right to drive of ICD/PM patients and the risk they pose to public safety, but rules for granting them a driving license are considerably different worldwide. For the same subset of patients driving restrictions may vary between 1 week and 1 year depending on the local law. Areas covered: In this article we systematically review driving restrictions in ICD/PM patients in 16 countries all over the world, highlighting their differences and analyzing data from the literature that underlie their formulation. Expert opinion: Current regulations are mainly based on historical data that do not take into account improvements in ICD/PM technologies and driving environment, which have made driving with an ICD/PM is substantially safe. Newer studies and updated regulatory documents are warranted to set the best driving restrictions and reach homogeneity worldwide.

2020 - Edoxaban and the Issue of Drug-Drug Interactions: From Pharmacology to Clinical Practice [Articolo su rivista]
Corsini, A.; Ferri, N.; Proietti, M.; Boriani, G.
abstract

Edoxaban, a direct factor Xa inhibitor, is the latest of the non-vitamin K antagonist oral anticoagulants (NOACs). Despite being marketed later than other NOACs, its use is now spreading in current clinical practice, being indicated for both thromboprophylaxis in patients with non-valvular atrial fibrillation (NVAF) and for the treatment and prevention of venous thromboembolism (VTE). In patients with multiple conditions, the contemporary administration of several drugs can cause relevant drug-drug interactions (DDIs), which can affect drugs’ pharmacokinetics and pharmacodynamics. Usually, all the NOACs are considered to have significantly fewer DDIs than vitamin K antagonists; notwithstanding, this is actually not true, all of them are affected by DDIs with drugs that can influence the activity (induction or inhibition) of P-glycoprotein (P-gp) and cytochrome P450 3A4, both responsible for the disposition and metabolism of NOACs to a different extent. In this review/expert opinion, we focused on an extensive report of edoxaban DDIs. All the relevant drugs categories have been examined to report on significant DDIs, discussing the impact on edoxaban pharmacokinetics and pharmacodynamics, and the evidence for dose adjustment. Our analysis found that, despite a restrained number of interactions, some strong inhibitors/inducers of P-gp and drug-metabolising enzymes can affect edoxaban concentration, just as it happens with other NOACs, implying the need for a dose adjustment. However, our analysis of edoxaban DDIs suggests that given the small propensity for interactions of this agent, its use represents an acceptable clinical decision. Still, DDIs can be significant in certain clinical situations and a careful evaluation is always needed when prescribing NOACs.

2020 - Effect on mortality of different routes of administration and loading dose of aspirin in patients with ST-segment elevation acute myocardial infarction treated with primary angioplasty [Articolo su rivista]
Rossi, Rosario; Bagnacani, Alessandra; Sgura, Fabio; Enrique Monopoli, Daniel; Coppi, Francesca; Talarico, Marisa; Rolando, Cristina; Boriani, Giuseppe
abstract

Aspirin is the cornerstone of the anti-platelet therapy during the acute phase of ST-segment elevation myocardial infarction (STEMI), and it can be administrated orally or intravenously. The oral loading dose of aspirin is well characterized, whereas there are little data on the optimal intravenous (IV) loading dose.

2020 - Effects of Anti-vitamin k oral anticoagulants on bone and cardiovascular health [Articolo su rivista]
Marietta, M.; Coluccio, V.; Boriani, G.; Luppi, M.
abstract

Vitamin K antagonist oral anticoagulants (VKAs) have been proven over 50 years to be highly effective and acceptably safe in many settings and are still used by millions of people worldwide. The main concern about the safety of VKAs regards the risk of bleeding, but there is accumulation evidence of their potentially negative effects beyond hemostasis. Indeed, VKAs impair the action of several Vitamin-K Dependent Proteins (VKDP), such as Bone Gla protein, Matrix Gla protein, Gas6 Protein, Periostin and Gla-Ric Protein, involved in bone and vascular metabolism, thus exerting a detrimental effect on bone and vascular health. Indeed, although the evidence regarding this issue is not compelling, it has been shown that VKAs use decreases bone mass density, increases the risk of bone fractures and accelerates the process of vascular and valvular calcification. Vascular calcification is a major concern in Chronic Kidney Disease (CKD) patients, also in absence of VKAs, because of mineral metabolism derangement, chronic inflammation and oxidative stress. Direct Oral AntiCoagulants (DOACs) do not affect VKDP involved in vascular and valvular calcification, and do not induce calcific valve degeneration in animal models, being a possible alternative to AVK for CKD patients. However, the efficacy and safety of DOACs in this population, suggested by some recent observations, requires confirmation by dedicated, randomized study. We reviewed here the effects of VKAs in bone and vascular health as compared to DOACs, in order to provide the physicians with some data useful to wisely choose the most suitable anticoagulant for every patient.

2020 - European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections - Endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS) [Articolo su rivista]
Blomstrom-Lundqvist, C.; Traykov, V.; Erba, P. A.; Burri, H.; Nielsen, J. C.; Bongiorni, M. G.; Poole, J.; Boriani, G.; Costa, R.; Deharo, J. -C.; Epstein, L. M.; Saghy, L.; Snygg-Martin, U.; Starck, C.; Tascini, C.; Strathmore, N.; Kalarus, Z.; Boveda, S.; Dagres, N.; Rinaldi, C. A.; Biffi, M.; Geller, L.; Sokal, A.; Birgersdotter-Green, U.; Lever, N.; Tajstra, M.; Kutarski, A.; Rodriguez, D. A.; Hasse, B.; Zinkernagel, A.; Mangoni, E.
abstract

Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially life-saving treatments for a number of cardiac conditions, but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased healthcare costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. Guidance on whether to use novel device alternatives expected to be less prone to infections and novel oral anticoagulants is also limited, as are definitions on minimum quality requirements for centres and operators and volumes. Moreover, an international consensus document on management of CIED infections is lacking. The recognition of these issues, the dissemination of results from important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections.

2020 - European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections - Endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS) [Articolo su rivista]
Blomstrom-Lundqvist, C.; Traykov, V.; Erba, P. A.; Burri, H.; Nielsen, J. C.; Bongiorni, M. G.; Poole, J.; Boriani, G.; Costa, R.; Deharo, J. -C.; Epstein, L. M.; Saghy, L.; Snygg-Martin, U.; Starck, C.; Tascini, C.; Strathmore, N.; Kalarus, Z.; Boveda, S.; Dagres, N.; Rinaldi, C. A.; Biffi, M.; Geller, L.; Sokal, A.; Birgersdotter-Green, U.; Lever, N.; Tajstra, M.; Kutarski, A.; Rodriguez, D. A.; Hasse, B.; Zinkernagel, A.; Mangoni, E.
abstract

Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially life-saving treatments for a number of cardiac conditions, but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased healthcare costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. Guidance on whether to use novel device alternatives expected to be less prone to infections and novel oral anticoagulants is also limited, as are definitions on minimum quality requirements for centres and operators and volumes. Moreover, an international consensus document on management of CIED infections is lacking. The recognition of these issues, the dissemination of results from important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections.

2020 - European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections-endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID), and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS) [Articolo su rivista]
Blomstrom-Lundqvist, C.; Traykov, V.; Erba, P. A.; Burri, H.; Nielsen, J. C.; Bongiorni, M. G.; Poole, J.; Boriani, G.; Costa, R.; Deharo, J. -C.; Epstein, L. M.; Saghy, L.; Snygg-Martin, U.; Starck, C.; Tascini, C.; Strathmore, N.
abstract

Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially lifesaving treatments for a number of cardiac conditions but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased health care costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well-recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, antibacterial envelopes, prolonged antibiotics post-implantation, and others. When compared with previous guidelines or consensus statements, the present consensus document gives guidance on the use of novel device alternatives, novel oral anticoagulants, antibacterial envelopes, prolonged antibiotics post-implantation, as well as definitions on minimum quality requirements for centres and operators and volumes. The recognition that an international consensus document focused on management of CIED infections is lacking, the dissemination of results from new important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a Novel 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections.

2020 - Female sex and stroke in atrial fibrillation: an intriguing relationship [Articolo su rivista]
Boriani, G.; Colella, J.; Imberti, J.; Fantecchi, E.; Vitolo, M.
abstract

2020 - Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial [Articolo su rivista]
Ponikowski, P.; Kirwan, B. -A.; Anker, S. D.; Mcdonagh, T.; Dorobantu, M.; Drozdz, J.; Fabien, V.; Filippatos, G.; Gohring, U. M.; Keren, A.; Khintibidze, I.; Kragten, H.; Martinez, F. A.; Metra, M.; Milicic, D.; Nicolau, J. C.; Ohlsson, M.; Parkhomenko, A.; Pascual-Figal, D. A.; Ruschitzka, F.; Sim, D.; Skouri, H.; van der Meer, P.; Lewis, B. S.; Comin-Colet, J.; von Haehling, S.; Cohen-Solal, A.; Danchin, N.; Doehner, W.; Dargie, H. J.; Motro, M.; Butler, J.; Friede, T.; Jensen, K. H.; Pocock, S.; Jankowska, E. A.; Azize, G.; Fernandez, A.; Zapata, G. O.; Garcia Pacho, P.; Glenny, A.; Ferre Pacora, F.; Parody, M. L.; Bono, J.; Beltrano, C.; Hershson, A.; Vita, N.; Luquez, H. A.; Cestari, H. G.; Fernandez, H.; Prado, A.; Berli, M.; Garcia Duran, R.; Thierer, J.; Diez, M.; Lobo Marquez, L.; Borelli, R. R.; Hominal, M. A.; Metra, M.; Ameri, P.; Agostoni, P.; Salvioni, A.; Fattore, L.; Gronda, E.; Ghio, S.; Turrini, F.; Uguccioni, M.; Di Biase, M.; Piepoli, M.; Savonitto, S.; Mortara, A.; Terrosu, P.; Fucili, A.; Boriani, G.; Midi, P.; Passamonti, E.; Cosmi, F.; van der Meer, P.; Van Bergen, P.; van de Wetering, M.; Al-Windy, N. Y. Y.; Tanis, W.; Meijs, M.; Groutars, R. G. E. J.; The, H. K. S.; Kietselaer, B.; van Kesteren, H. A. M.; Beelen, D. P. W.; Heymeriks, J.; Van de Wal, R.; Schaap, J.; Emans, M.; Westendorp, P.; Nierop, P. R.; Nijmeijer, R.; Manintveld, O. C.; Dorobantu, M.; Darabantiu, D. A.; Zdrenghea, D.; Toader, D. M.; Petrescu, L.; Militaru, C.; Crisu, D.; Tomescu, M. C.; Stanciulescu, G.; Rodica Dan, A.; Iosipescu, L. C.; Serban, D. L.; Drozdz, J.; Szachniewicz, J.; Bronisz, M.; Tycinska, A.; Wozakowska-Kaplon, B.; Mirek-Bryniarska, E.; Gruchala, M.; Nessler, J.; Straburzynska-Migaj, E.; Mizia-Stec, K.; Szelemej, R.; Gil, R.; Gasior, M.; Gotsman, I.; Halabi, M.; Shochat, M.; Shechter, M.; Witzling, V.; Zukermann, R.; Arbel, Y.; Flugelman, M.; Ben-Gal, T.; Zvi, V.; Kinany, W.; Weinstein, J. M.; Atar, S.; Goland, S.; Milicic, D.; Horvat, D.; Tusek, S.; Udovicic, M.; Sutalo, K.; Samodol, A.; Pesek, K.; Artukovic, M.; Ruzic, A.; Sikic, J.; Mcdonagh, T.; Trevelyan, J.; Wong, Y. -K.; Gorog, D.; Ray, R.; Pettit, S.; Sharma, S.; Kabir, A.; Hamdan, H.; Tilling, L.; Baracioli, L.; Nigro Maia, L.; Dutra, O.; Reis, G.; Pimentel Filho, P.; Saraiva, J. F.; Kormann, A.; dos Santos, F. R.; Bodanese, L.; Almeida, D.; Precoma, D.; Rassi, S.; Costa, F.; Kabbani, S.; Abdelbaki, K.; Abdallah, C.; Arnaout, M. S.; Azar, R.; Chaaban, S.; Raed, O.; Kiwan, G.; Hassouna, B.; Bardaji, A.; Zamorano, J.; del Prado, S.; Gonzalez Juanatey, J. R.; Ga Bosa Ojeda, F. I.; Gomez Bueno, M.; Molina, B. D.; Pascual Figal, D. A.; Sim, D.; Yeo, T. J.; Loh, S. Y.; Soon, D.; Ohlsson, M.; Smith, J. G.; Gerward, S.; Khintibidze, I.; Lominadze, Z.; Chapidze, G.; Emukhvari, N.; Khabeishvili, G.; Chumburidze, V.; Paposhvili, K.; Shaburishvili, T.; Parhomenko, O.; Kraiz, I.; Koval, O.; Zolotaikina, V.; Malynovsky, Y.; Vakaliuk, I.; Rudenko, L.; Tseluyko, V.; Stanislavchuk, M.
abstract

Background: Intravenous ferric carboxymaltose has been shown to improve symptoms and quality of life in patients with chronic heart failure and iron deficiency. We aimed to evaluate the effect of ferric carboxymaltose, compared with placebo, on outcomes in patients who were stabilised after an episode of acute heart failure. Methods: AFFIRM-AHF was a multicentre, double-blind, randomised trial done at 121 sites in Europe, South America, and Singapore. Eligible patients were aged 18 years or older, were hospitalised for acute heart failure with concomitant iron deficiency (defined as ferritin <100 μg/L, or 100–299 μg/L with transferrin saturation <20%), and had a left ventricular ejection fraction of less than 50%. Before hospital discharge, participants were randomly assigned (1:1) to receive intravenous ferric carboxymaltose or placebo for up to 24 weeks, dosed according to the extent of iron deficiency. To maintain masking of patients and study personnel, treatments were administered in black syringes by personnel not involved in any study assessments. The primary outcome was a composite of total hospitalisations for heart failure and cardiovascular death up to 52 weeks after randomisation, analysed in all patients who received at least one dose of study treatment and had at least one post-randomisation data point. Secondary outcomes were the composite of total cardiovascular hospitalisations and cardiovascular death; cardiovascular death; total heart failure hospitalisations; time to first heart failure hospitalisation or cardiovascular death; and days lost due to heart failure hospitalisations or cardiovascular death, all evaluated up to 52 weeks after randomisation. Safety was assessed in all patients for whom study treatment was started. A pre-COVID-19 sensitivity analysis on the primary and secondary outcomes was prespecified. This study is registered with ClinicalTrials.gov, NCT02937454, and has now been completed. Findings: Between March 21, 2017, and July 30, 2019, 1525 patients were screened, of whom 1132 patients were randomly assigned to study groups. Study treatment was started in 1110 patients, and 1108 (558 in the carboxymaltose group and 550 in the placebo group) had at least one post-randomisation value. 293 primary events (57·2 per 100 patient-years) occurred in the ferric carboxymaltose group and 372 (72·5 per 100 patient-years) occurred in the placebo group (rate ratio [RR] 0·79, 95% CI 0·62–1·01, p=0·059). 370 total cardiovascular hospitalisations and cardiovascular deaths occurred in the ferric carboxymaltose group and 451 occurred in the placebo group (RR 0·80, 95% CI 0·64–1·00, p=0·050). There was no difference in cardiovascular death between the two groups (77 [14%] of 558 in the ferric carboxymaltose group vs 78 [14%] in the placebo group; hazard ratio [HR] 0·96, 95% CI 0·70–1·32, p=0·81). 217 total heart failure hospitalisations occurred in the ferric carboxymaltose group and 294 occurred in the placebo group (RR 0·74; 95% CI 0·58–0·94, p=0·013). The composite of first heart failure hospitalisation or cardiovascular death occurred in 181 (32%) patients in the ferric carboxymaltose group and 209 (38%) in the placebo group (HR 0·80, 95% CI 0·66–0·98, p=0·030). Fewer days were lost due to heart failure hospitalisations and cardiovascular death for patients assigned to ferric carboxymaltose compared with placebo (369 days per 100 patient-years vs 548 days per 100 patient-years; RR 0·67, 95% CI 0·47–0·97, p=0·035). Serious adverse events occurred in 250 (45%) of 559 patients in the ferric carboxymaltose group and 282 (51%) of 551 patients in the placebo group. Interpretation: In patients with iron deficiency, a left ventricular ejection fraction of less than 50%, and who were stabilised after an episode of acute heart failure, treatment with ferric carboxymaltose was safe and reduced the risk of heart failure hospitalisations, with no apparent effec

2020 - From meta-analysis to the individual patient with atrial fibrillation and coronary artery disease: the complexity of antithrombotic treatment in real-world clinical practice and the need for a tailored approach [Articolo su rivista]
Boriani, G.; Imberti, J. F.; Vitolo, M.
abstract

2020 - Impact of COVID-19 pandemic on the clinical activities related to arrhythmias and electrophysiology in Italy: results of a survey promoted by AIAC (Italian Association of Arrhythmology and Cardiac Pacing) [Articolo su rivista]
Boriani, G.; Palmisano, P.; Guerra, F.; Bertini, M.; Zanotto, G.; Lavalle, C.; Notarstefano, P.; Accogli, M.; Bisignani, G.; Forleo, G. B.; Landolina, M.; D'Onofrio, A.; Ricci, R.; De Ponti, R.; Luise, R.; Grieco, P.; Pangallo, A.; Quirino, G.; Talarico, A.; De Bonis, S.; Carbone, A.; De Simone, A.; D'Onofrio, A.; Nappi, F.; Rotondi, F.; Stabile, G.; Uran, C.; Bertini, M.; Balla, C.; Boggian, G.; Carinci, V.; Barbato, G.; Corzani, A.; Sabbatani, P.; Erminio, M.; Imberti, J. F.; Malavasi, N.; Pastori, P.; Quartieri, F.; Bottoni, N.; Saporito, D.; Virzi, S.; Sassone, B.; Zardini, M.; Placci, A.; Ziacchi, M.; Massaro, G.; Adamo, F.; Scaccia, A.; Spampinato, A.; Biscione, F.; Castro, A.; Cauti, F.; Rossi, P.; Cinti, C.; Gatto, M.; Kol, A.; Narducci, M. L.; Pelargonio, G.; Patruno, N.; Pignalberi, C.; Ricci, R. P.; Ricciardi, D.; Santini, L.; Tancredi, M.; Di Belardino, N.; Pentimalli, F.; Zoni-Berisso, M.; Belotti, G.; Chieffo, E.; Cilloni, S.; Doni, L. A.; Forleo, G. B.; Gardini, A.; Malaspina, D.; Mazzone, P.; Della Bella, P.; Negro, R.; Perego, G. B.; Rordorf, R.; Cipolletta, L.; Russo, A. D.; Luzi, M.; Amellone, C.; Ebrille, E.; Favro, E.; Lucciola, M. T.; Devecchi, C.; Rametta, F.; Devecchi, F.; Matta, M.; Sant'Andrea, A. O.; Santagostino, M.; Dell'Era, G.; Candida, T. R.; Bonfantino, V. M.; Gianfrancesco, D.; Guido, A.; Pellegrino, P. L.; Pisano, E. C. L.; Rillo, M.; Palama, Z.; Sai, R.; Santobuono, V. E.; Favale, S.; Scicchitano, P.; Nissardi, V.; Campisi, G.; Sgarito, G.; Arena, G.; Casorelli, E.; Fumagalli, S.; Giaccardi, M.; Notarstefano, P.; Nesti, M.; Padeletti, M.; Rossi, A.; Piacenti, M.; Del Greco, M.; Catanzariti, D.; Manfrin, M.; Werner, R.; Marini, M.; Andreoli, C.; Fedeli, F.; Mazza, A.; Pagnotta, F.; Ridarelli, M.; Molon, G.; Rossillo, A.
abstract

COVID-19 outbreak had a major impact on the organization of care in Italy, and a survey to evaluate provision of for arrhythmia during COVID-19 outbreak (March–April 2020) was launched. A total of 104 physicians from 84 Italian arrhythmia centres took part in the survey. The vast majority of participating centres (95.2%) reported a significant reduction in the number of elective pacemaker implantations during the outbreak period compared to the corresponding two months of year 2019 (50.0% of centres reported a reduction of > 50%). Similarly, 92.9% of participating centres reported a significant reduction in the number of implantable cardioverter-defibrillator (ICD) implantations for primary prevention, and 72.6% a significant reduction of ICD implantations for secondary prevention (> 50% in 65.5 and 44.0% of the centres, respectively). The majority of participating centres (77.4%) reported a significant reduction in the number of elective ablations (> 50% in 65.5% of the centres). Also the interventional procedures performed in an emergency setting, as well as acute management of atrial fibrillation had a marked reduction, thus leading to the conclusion that the impact of COVID-19 was disrupting the entire organization of health care, with a massive impact on the activities and procedures related to arrhythmia management in Italy.

2020 - Impact of Cardiac Implantable Electronic Device Infection: A Clinical and Economic Analysis of the WRAP-IT Trial [Articolo su rivista]
Wilkoff, B. L.; Boriani, G.; Mittal, S.; Poole, J. E.; Kennergren, C.; Corey, G. R.; Love, J. C.; Augostini, R.; Faerestrand, S.; Wiggins, S. S.; Healey, J. S.; Holbrook, R.; Lande, J. D.; Lexcen, D. R.; Willey, S.; Tarakji, K. G.
abstract

Background: Current understanding of the impact of cardiac implantable electronic device (CIED) infection is based on retrospective analyses from medical records or administrative claims data. The WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) offers an opportunity to evaluate the clinical and economic impacts of CIED infection from the hospital, payer, and patient perspectives in the US healthcare system. Methods: This was a prespecified, as-treated analysis evaluating outcomes related to major CIED infections: mortality, quality of life, disruption of CIED therapy, healthcare utilization, and costs. Payer costs were assigned using medicare fee for service national payments, while medicare advantage, hospital, and patient costs were derived from similar hospital admissions in administrative datasets. Results: Major CIED infection was associated with increased all-cause mortality (12-month risk-adjusted hazard ratio, 3.41 [95% CI, 1.81-6.41]; P<0.001), an effect that sustained beyond 12 months (hazard ratio through all follow-up, 2.30 [95% CI, 1.29-4.07]; P=0.004). Quality of life was reduced (P=0.004) and did not normalize for 6 months. Disruptions in CIED therapy were experienced in 36% of infections for a median duration of 184 days. Mean costs were $55 547±$45 802 for the hospital, $26 867±$14 893, for medicare fee for service and $57 978±$29 431 for Medicare Advantage (mean hospital margin of -$30 828±$39 757 for medicare fee for service and -$6055±$45 033 for medicare advantage). Mean out-of-pocket costs for patients were $2156±$1999 for medicare fee for service, and $1658±$1250 for medicare advantage. Conclusions: This large, prospective analysis corroborates and extends understanding of the impact of CIED infections as seen in real-world datasets. CIED infections severely impact mortality, quality of life, healthcare utilization, and cost in the US healthcare system. Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT02277990.

2020 - Influence of BMI and geographical region on prescription of oral anticoagulants in newly diagnosed atrial fibrillation: The GLORIA-AF Registry Program [Articolo su rivista]
Boriani, G.; Huisman, M. V.; Teutsch, C.; Marler, S.; Franca, L. R.; Lu, S.; Lip, G. Y. H.
abstract

Objective: To investigate the association between body mass index (BMI) and oral anticoagulant (OAC) prescription in atrial fibrillation (AF). Methods: Patients with newly diagnosed non-valvular AF (<3 months) with ≥1 stroke risk factors enrolled in the Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) in Asia, Europe and North America were evaluated. Results: The cohort (n = 13,793) comprised patients from all BMI categories (kg/m2): 1.4% were underweight (<18.5), 27.3% had a normal BMI (18.5 to <25), 37.9% were overweight (25 to <30), 19.3% were moderately obese (30 to <35), and 12.7% were morbidly obese (≥35). The highest proportion of Asians had a BMI of 18.5 to <25 kg/m2, while the highest proportion of patients from Europe and North America were overweight and a substantial proportion of North Americans morbidly obese. In the multivariable analysis, the probability ratio of non-prescription of OAC, as compared to normal BMI, decreased for overweight (RR = 0.907), moderately obese (RR = 0.802) and severe very severe obese patients (RR = 0.659). Moreover, the probability ratio of non-prescription of OACs was increased in the Asia or North America regions, as compared with Europe, in patients aged <65 years or female patients, as well as in patients with prior bleeding or vascular disease. Conclusions: The distribution of BMI differed among the continents. An increased BMI was associated with a lower probability of non-prescription of OACs, as compared with a normal BMI. The probability of non-prescription of OACs was increased in the Asia or North America regions, as compared with Europe.

2020 - Intrahospital organizational model of remote monitoring data sharing, for a global management of patients with cardiac implantable electronic devices: a document of the Italian Association of Arrhythmology and Cardiac Pacing [Articolo su rivista]
Zanotto, G.; Melissano, D.; Baccillieri, S.; Campana, A.; Caravati, F.; Maines, M.; Platania, F.; Zuccaro, L.; Landolina, M.; Berisso, M. Z.; Boriani, G.; Ricci, R. P.
abstract

: In recent years, the increasing number of patients with a cardiac implantable electronic device (CIED) has required different approaches in terms of the device's control and surveillance. It is increasingly difficult to keep the traditional in-office protocol device's control: we must think of a different organization dedicated to the activity of remote control and monitoring (RC/RM) of devices and patients.A CIED team structured with nurses, technicians and physicians should be organized inside the hospital, with the aim of CIED patients' managing and of creating a network between the various departments.Small hospitals may not be able to manage independently the CIEDs RC/RM and it is possible to hypothesize the creation of a collaborative network between neighbouring structures.This activity must combine the use of technology with the ability to take care of patients and to maintain adequate and meaningful relationships.

2020 - Kidney dysfunction and short term all-cause mortality after transcatheter aortic valve implantation [Articolo su rivista]
Sgura, F. A.; Arrotti, S.; Magnavacchi, P.; Monopoli, D.; Gabbieri, D.; Banchelli, F.; Tondi, S.; Denegri, A.; D'Amico, R.; Guiducci, V.; Vignali, L.; Boriani, G.
abstract

Background: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) has been associated with worse outcomes. However, the impact on outcome of AKI in TAVI-patients is not well established. Methods: Inoperable patients with severe aortic stenosis (AS) undergoing TAVI in 2010-2018 were enrolled in this study. AKI and chronic kidney disease (CKD) were defined according to KDIGO guidelines. Patients were divided in two groups according to post-procedural AKI development. The primary endpoint was 30-day all-cause mortality across the two groups. Results: A total of 373 patients (mean age 82.3 ± 6) were analyzed. Compared to non-AKI patients, those who developed AKI, were treated more frequently with trans-apical TAVI (66% vs 35%, p<0.01), with greater amount of contrast medium (200.6 vs 170.4 ml, p=0.02) and in presence of clinically significant peripheral artery disease (PAD, 33% vs 21%, p=0.04). Trans-apical access (OR 3.24, 95% CI 1.76-5.60, p<0.01) was associated with a 3-fold risk of AKI. After adjustment for age, Society of Thoracic Surgery risk score (STS), PAD, access type, EF and contrast medium amount, patients with AKI presented an increased risk of 30-day all-cause mortality (HR=1.25, 95%CI 1.09-1.69, p=0.008). Patients with CKD IV and V, who developed AKI, presented a 9-fold 30-day mortality risk (HR=9.71, 95% CI 2.40-39.2, p=0.001). Conclusion: In our analysis, AKI was a strong predictor of 30-day all-cause mortality. Particularly, patients with severe CKD with AKI showed the highest 30-day mortality risk. Thus, this group of patients might benefit from closer monitoring and specific kidney protection therapies.

2020 - Managing atrial fibrillation: the need for an individualized approach even in the emergency department [Articolo su rivista]
Boriani, G.; Imberti, J. F.; Valenti, A. C.; Malavasi, V. L.; Vitolo, M.
abstract

2020 - Obesity Paradox in Atrial Fibrillation: Implications for Outcomes and Relationship with Oral Anticoagulant Drugs [Articolo su rivista]
Proietti, M.; Boriani, G.
abstract

In the last 40 years, concern about the obesity epidemic has increased. Data from the current literature highlight a strong relationship between obesity and atrial fibrillation (AF), particularly in relation to an increased risk for incident and recurrent AF. A phenomenon called the “obesity paradox” has emerged: the apparently counterintuitive evidence from epidemiological data indicating that overweight and obese patients may have a better prognosis than healthy-weight patients. A differential impact of oral anticoagulants (OACs) in terms of effectiveness and safety in the various body mass index categories has been postulated, particularly in the comparison between non-vitamin-K antagonist oral anticoagulants and vitamin K antagonists. This review aims to summarize the evidence on the impact of obesity in patients with AF, focusing on descriptions of the obesity paradox and its relationships with OAC treatment.

2020 - One-year clinical events and management of patients with atrial fibrillation hospitalized in cardiology centers: Data from the BLITZ-AF study [Articolo su rivista]
Cemin, R.; Colivicchi, F.; Maggioni, A. P.; Boriani, G.; De Luca, L.; Di Lenarda, A.; Di Pasquale, G.; Fabbri, G.; Lucci, D.; Gulizia, M. M.
abstract

Background: The management of atrial fibrillation (AF) has changed with the introduction of direct anticoagulants (DOACs) and new techniques such as catheter ablation. An update collection of data from “real world” AF patients followed by cardiologists is useful to obtain information on both management, outcomes and guideline adherence in clinical practice. Methods: Follow-up information on survival, embolic and bleeding events and hospital readmission, persistence of oral anticoagulant (OAC) therapy was collected in 84 centers participating to the BLITZ-AF study. Results: Patients were followed for a median of 366 days (IQR: 356–378) and vital status was available for 2159 patients. Mortality was 9.2%. Heart failure was the most common cardiovascular cause of death (70%) followed by arrhythmias (6.7%), acute coronary syndrome (5.0%) and ischemic stroke (2.5%). During follow-up 18.1% of the patients were readmitted, mainly (81.3%) for cardiovascular causes. Patients on OAC were 83.4%, 9.1% were on antiplatelets and 7.5% did not receive antithrombotic therapy. The use of DOACs increased from 42.1% to 46.4% during the follow-up, OAC discontinuation occurred in 9.1%. AF recurrences occurred in 23.4% of the patients discharged in sinus rhythm. Rate control strategy was adopted in 55.9% and beta-blockers were the most used drugs (81.9%). Amiodarone (22%) and flecainide (9.7%) were the most frequent used antiahrrythmic drugs. Conclusions: The follow-up of the BLITZ-AF study provide an up to date picture of the clinical course of patients with AF, who appear frequently affected by heart failure and severe comorbidities which might have led to the high mortality rate.

2020 - Optimal Use of Echocardiography in Management of Thrombosis After Anterior Myocardial Infarction [Articolo su rivista]
Barbieri, A.; Mantovani, F.; Bursi, F.; Faggiano, A.; Boriani, G.; Faggiano, P.
abstract

Despite advancement in therapy and management, left ventricular thrombus (LVT) after anterior myocardial infarction (MI) is sporadically encountered and remains associated with a very high risk of major cardiovascular events and mortality. Cardiac magnetic resonance (CMR) is considered the gold standard technique for LVT detection, but it is a time-consuming and expensive test not available in all centers, especially when repeated examinations are necessary. Transthoracic echocardiography represents a useful tool to screen for LVT and to identify predictors of high risk of developing LVT. The advances in ultrasound technology and the use of contrast agents may potentially help clinicians to identify LVT and the use of sequential echocardiography for each patient with acute MI complicated by LVT may provide an opportunity to quantify regression and its correlation with outcomes to tailor the management of these patients. Hence, this narrative review focuses on the added value of echocardiographic-guided LVT management in patients with recent anterior MI to reduce mortality and morbidity excess related to LVT based on current evidence.

2020 - Optimized Implementation of cardiac resynchronization therapy - a call for action for referral and optimization of care [Articolo su rivista]
Mullens, Wilfried; Auricchio, Angelo; Martens, Pieter; Witte, Klaus; Cowie, Martin R; Delgado, Victoria; Dickstein, Kenneth; Linde, Cecilia; Vernooy, Kevin; Leyva, Francisco; Bauersachs, Johann; Israel, Carsten W; Lund, Lars; Donal, Erwan; Boriani, Giuseppe; Jaarsma, Tiny; Berruezo, Antonio; Traykov, Vassil; Yousef, Zaheer; Kalarus, Zbigniew; Nielsen, Jens Cosedis; Steffel, Jan; Vardas, Panos; Coats, Andrew; Seferovic, Petar; Edvardsen, Thor; Heidbuchel, Hein; Ruschitzka, Frank; Leclercq, Christophe
abstract

Cardiac resynchronization therapy (CRT) is one of the most effective therapies for heart failure with reduced ejection fraction and leads to improved quality of life, reductions in heart failure hospitalization rates and reduces all-cause mortality. Nevertheless, up to two-thirds of eligible patients are not referred for CRT. Furthermore, post implantation follow-up is often fragmented and suboptimal, hampering the potential maximal treatment effect. This joint position statement from three ESC Associations, HFA, EHRA and EACVI focuses on optimized implementation of CRT. We offer theoretical and practical strategies to achieve more comprehensive CRT referral and post-procedural care by focusing on four actionable domains; (I) overcoming CRT under-utilization, (II) better understanding of pre-implant characteristics, (III) abandoning the term 'non-response' and replacing this by the concept of disease modification, and (IV) implementing a dedicated post-implant CRT care pathway.

2020 - Position paper of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) on driving by patients with cardiac implantable electronic devices [Articolo su rivista]
Palmisano, P.; Guerra, F.; Bisignani, G.; Forleo, G. B.; Landolina, M.; Soldati, E.; Stabile, G.; Zanotto, G.; Berisso, M. Z.; De Ponti, R.; Boriani, G.; Ricci, R. P.
abstract

In patients with cardiac implantable electronic devices (CIEDs) (implantable cardioverter-defibrillators [ICDs] and pacemakers [PMs]), the potential risk of suddenly being unable to drive, and hence of causing road accidents, is higher than in the general population. In ICD patients, this risk stems from the possibility that an arrhythmic event leading to loss of consciousness may occur while driving. In PM patients, it may be the result of a device malfunction in a PM-dependent patient. To determine a CIED patient's ability to drive, two variables must be taken into account: (i) the risk of events, which depends on the type of underlying heart disease (ICD patients have a higher risk than PM patients); (ii) the time spent driving and the type of vehicle driven (professional drivers are at higher risk than private drivers). This position paper reports the recommendations of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) regarding driving by patients with CIEDs, on the basis of the available literature and the European reference recommendations.

2020 - Protective role of chronic treatment with direct oral anticoagulants in elderly patients affected by interstitial pneumonia in COVID-19 era [Articolo su rivista]
Rossi, R.; Coppi, F.; Talarico, M.; Boriani, G.
abstract

2020 - Protective role of statins in COVID 19 patients: importance of pharmacokinetic characteristics rather than intensity of action [Articolo su rivista]
Rossi, R.; Talarico, M.; Coppi, F.; Boriani, G.
abstract

2020 - Radiotherapy-induced malfunctions of cardiac implantable electronic devices in cancer patients [Articolo su rivista]
Malavasi, V. L.; De Marco, G.; Imberti, J. F.; Placentino, F.; Vitolo, M.; Mazzeo, E.; Cicoria, G.; Casali, E.; Turco, V.; Lohr, F.; Boriani, G.
abstract

The number of patients with cardiac implantable electronic devices (CIEDs) requiring radiation therapy (RT) for cancer treatment is increasing. The purpose of this study is to estimate the prevalence, possible predictors, and clinical impact of RT-related CIEDs malfunctions. We retrospectively reviewed the medical records of all pacemaker (PM)/implantable cardioverter-defibrillator (ICD) patients who underwent RT in the last 14 years. One hundred and twenty-seven patients who underwent 150 separate RT courses were analysed (99 with a PM and 27 with an ICD). Of note, 21/127 (16.6%) patients were PM-dependent. Neutron-producing RT was used in 37/139 (26.6%) courses, whereas non-neutron-producing RT was used in 102/139 (73.4%) courses. The cumulative dose (Dmax) delivered to the CIED exceeded 5 Gy only in 2/132 (1.5%) cases. Device malfunctions were observed in 3/150 (2%) RT courses, but none was life-threatening or led to a major clinical event and all were resolved by CIED reprogramming. In all cases, the Dmax delivered to the CIED was < 2 Gy. Two malfunctions occurred in the 37 patients treated with neutron-producing RT (5.4%), and 1 malfunction occurred in the 102 patients treated with non-neutron-producing RT (1%) (p = 0.17). Device relocation from the RT field was performed in 2/127 (1.6%) patients. RT in patients with CIED is substantially safe if performed in an appropriately organized environment, with uncommon CIEDs malfunctions and no major clinical events. Neutron-producing energies, rather than Dmax, seem to increase the risk of malfunctions. Device interrogation on a regular basis is advised to promptly manage CIED malfunctions.

2020 - Shoulder Function After Cardioverter-Defibrillator Implantation: 5-Year Follow-up [Articolo su rivista]
Martignani, Cristian; Massaro, Giulia; Mazzotti, Andrea; Pegreffi, Francesco; Ziacchi, Matteo; Biffi, Mauro; Porcellini, Giuseppe; Boriani, Giuseppe; Diemberger, Igor
abstract

2020 - Tailored oral anticoagulant prescription in patients with atrial fibrillation: Use and misuse of clinical risk prediction scores [Articolo su rivista]
Proietti, M.; Vitolo, M.; Boriani, G.
abstract

2020 - Temporal patterns of premature atrial complexes predict atrial fibrillation occurrence in bradycardia patients continuously monitored through pacemaker diagnostics [Articolo su rivista]
Boriani, G.; Botto, G. L.; Pieragnoli, P.; Ricci, R.; Biffi, M.; Marini, M.; Sagone, A.; Avella, A.; Pignalberi, C.; Ziacchi, M.; Ricciardi, G.; Tartaglione, E.; Grammatico, A.; Gasparini, M.
abstract

The frequency of premature atrial complexes (PACs) has been related with atrial fibrillation (AF) occurrence and adverse prognosis. Research objective was to evaluate whether temporal patterns of PACs are directly associated with AF onset in pacemaker patients with continuous monitoring of the atrial rhythm. Overall, 193 pacemaker patients (49% female, 72 ± 9 years old), enrolled in a national registry, were analyzed. Frequency of daily PACs was measured in a 14-day initial observation period, during which patients were in sinus rhythm. In the following period, temporal occurrence and frequency of daily PACs and eventual onset of AF were derived by pacemaker diagnostics. In the run-in period, median PACs frequency was 614 PACs/day (interquartile range 70–3056). Subsequently, in a median follow-up of 6 months, AF occurred in 109 patients, in particular in 37/96 (38.5%) patients with a PAC rate < 614 PACs/day and in 72/97 (74.2%) patients with PAC rate ≥ 614 PACs/day (p < 0.001). In patients with AF occurrence, the number of daily PACs, normalized by dividing for the average of PACs in ten preceding days, progressively increased in the 5 days preceding AF. Cox model predictive analysis showed that the risk of AF was significantly higher in patients with a relative increase of the daily PACs higher than 30% compared with PACs average number in ten preceding days [hazard ratio (95% confidence interval) 3.67 (2.40–5.59), p < 0.001]. PACs frequency increases in the 5 days preceding AF onset. A relative increase of the daily PACs is significantly associated with the risk of AF occurrence.

2020 - Temporary transvenous cardiac pacing: a survey on current practice [Articolo su rivista]
Diemberger, I.; Massaro, G.; Rossillo, A.; Chieffo, E.; Dugo, D.; Guarracini, F.; Pellegrino, P. L.; Perna, F.; Landolina, M.; De Ponti, R.; Berisso, M. Z.; Ricci, R. P.; Boriani, G.
abstract

BACKGROUND: Temporary transvenous cardiac pacing (TTCP) is a standard procedure in current practice, despite limited coverage in consensus guidelines. However, many authors reported several complications associated with TTCP, especially development of infections of cardiac implantable electronic devices (CIED). The aim of this survey was to provide a country-wide picture of current practice regarding TTCP. METHODS: Data were collected using an online survey that was administered to members of the Italian Association of Arrhythmology and Cardiac Pacing. RESULTS: We collected data from 102 physicians, working in 81 Italian hospitals from 17/21 regions. Our data evidenced that different strategies are adopted in case of acute bradycardia with a tendency to limit TTCP mainly to advanced atrioventricular block. However, some centers reported a greater use in elective procedures. TTCP is usually performed by electrophysiologists or interventional cardiologists and, differently from previous reports, mainly by a femoral approach and with nonfloating catheters. We found high inhomogeneity regarding prevention of infections and thromboembolic complications and in post-TTCP management, associated with different TTCP volumes and a strategy for management of acute bradyarrhythmias. CONCLUSION: This survey evidenced a high inhomogeneity in the approaches adopted by Italian cardiologists for TTCP. Further studies are needed to explore if these divergences are associated with different long-term outcomes, especially incidence of CIED-related infections.

2020 - The Euro Heart Survey and EURObservational Research Programme (EORP) in atrial fibrillation registries: contribution to epidemiology, clinical management and therapy of atrial fibrillation patients over the last 20 years [Articolo su rivista]
Vitolo, M.; Proietti, M.; Harrison, S.; Lane, D. A.; Potpara, T. S.; Boriani, G.; Lip, G. Y. H.
abstract

Management of atrial fibrillation (AF) may be challenging in clinical practice. Given the complexity of AF patients and the continuous advances in AF clinical management, there is a need for standardized programmes aimed at collecting so-called ‘real-world clinical practice data’ regarding the epidemiology, diagnostic/therapeutic/management practices and assessing adherence to guidelines. Over the past 20 years, the number of registries and surveys based on real-world AF patients has been dramatically increased. In Europe, based on the Euro Heart Survey (EHS) and the EURObservational Research Programme (EORP), a large series of studies based on these prospective, observational, large-scale multicentre registries on AF have been published. This narrative review gives an overview of these two projects on AF led by the European Society of Cardiology, focusing mainly on the contribution that these studies have provided to AF management and patient outcomes. Both the EHS and the EORP registries have collected a large amount of data regarding contemporary clinical practice, and despite some limitations, mainly related to their observational nature, these registries have contributed to our knowledge and clinical management of AF patients.

2020 - The Pacemaker and Implantable Cardioverter-Defibrillator Registry of the Italian Association of Arrhythmology and Cardiac Pacing - Annual report 2018 [Articolo su rivista]
Proclemer, A.; Zecchin, M.; D'Onofrio, A.; Boriani, G.; Ricci, R. P.; Rebellato, L.; Ghidina, M.; Bianco, G.; Bernardelli, E.; Miconi, A.; Zorzin, A. F.; Gregori, D.
abstract

BACKGROUND: The pacemaker (PM) and implantable cardioverter-defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) monitors the main epidemiological data in real-world practice. The survey for the 2018 activity collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers. METHODS: The Registry collects prospectively national PM and ICD implantation activity on the basis of European cards. RESULTS: PM Registry: data about 23 912 PM implantations were collected (20 084 first implants and 3828 replacements). The number of collaborating centers was 180. Median age of treated patients was 81 years (75 quartile I; 86 quartile III). ECG indications included atrioventricular conduction disorders in 34.5% of first PM implants, sick sinus syndrome in 18.3%, atrial fibrillation plus bradycardia in 13.0%, other in 34.2%. Among atrioventricular conduction defects, third-degree atrioventricular block was the most common type (19.2% of first implants). Use of single-chamber PMs was reported in 24.9% of first implants, of dual-chamber PMs in 67.6%, of PMs with cardiac resynchronization therapy (CRT) in 1.6%, and of single lead atrial-synchronized ventricular stimulation (VDD/R PMs) in 5.9%. ICD Registry: data about 18 353 ICD implantations were collected (13 944 first implants and 4359 replacements). The number of collaborating centers was 433. Median age of treated patients was 71 years (63 quartile I; 78 quartile III). Primary prevention indication was reported in 84.3% of first implants, secondary prevention in 15.7% (cardiac arrest in 5.3%). A single-chamber ICD was used in 27.9% of first implants, dual-chamber ICD in 31.9% and biventricular ICD in 40.2%. CONCLUSIONS: The PM and ICD Registry appears fundamental for monitoring PM and ICD utilization on a large national scale with rigorous examination of demographics and clinical indications. The PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The use of CRT-PM regards a very limited number of patients. The ICD Registry documented a large use of prophylactic and biventricular ICD, reflecting a favorable adherence to trials and guidelines in clinical practice. In order to increase and optimize the cooperation of Italian implanting centers, online data entry (http://www.aiac.it/riprid) should be adopted at large scale.

2020 - The unmet needs of sudden cardiac death. The role of the wearable cardioverter defibrillator when the risk is transient or uncertain [Articolo su rivista]
Guerra, F.; Palmisano, P.; Bisignani, G.; Forleo, G.; Landolina, M.; Soldati, E.; Stabile, G.; Zanotto, G.; Berisso, M. Z.; Boriani, G.; De Ponti, R.; Ricci, R. P.
abstract

Sudden cardiac death is defined as a natural death due to termination of cardiac activity associated with loss of consciousness, spontaneous breathing and circulation. Nowadays, the prevention of sudden cardiac death represents a major issue and many areas of uncertainty are not met by current evidences. Among those, reliable tools for risk stratification are still lacking, as well as solution for patients in which the risk of sudden cardiac death is due to a transient or correctable condition.The concept of the wearable cardioverter defibrillator is based on a potential solution for such grey areas. It merges long-term monitoring capabilities, shockable rhythm discrimination and shock delivery without the need for bystander assistance or invasive procedures. The present review aims to summarize current problems in dealing with this insidious condition, and to discuss potential options for patients in whom sudden cardiac death could be prevented more safely and cost-effectively.

2020 - What do we do about atrial high rate episodes? [Articolo su rivista]
Boriani, Giuseppe; Vitolo, Marco; Imberti, Jacopo Francesco; Potpara, Tatjana S; Lip, Gregory Y H
abstract

Atrial high rate episodes (AHREs) are defined as asymptomatic atrial tachyarrhythmias detected by cardiac implantable electronic devices with atrial sensing, providing automated continuous monitoring and tracings storage, occurring in subjects with no previous clinical atrial fibrillation (AF) and with no AF detected at conventional electrocardiogram recordings. AHREs are associated with an increased thrombo-embolic risk, which is not negligible, although lower than that of clinical AF. The thrombo-embolic risk increases with increasing burden of AHREs, and moreover, AHREs burden shows a dynamic pattern, with tendency to progression along with time, with potential transition to clinical AF. The clinical management of AHREs, in particular with regard to prophylactic treatment with oral anticoagulants (OACs), remains uncertain and heterogeneous. At present, in patients with confirmed AHREs, as a result of device tracing analysis, an integrated, individual and clinically-guided assessment should be applied, taking into account the patients' risk of stroke (to be reassessed regularly) and the AHREs burden. The use of OACs, preferentially non-vitamin K antagonists OACs, may be justified in selected patients, such as those with longer AHREs durations (in the range of several hours or ≥24 h), with no doubts on AF diagnosis after device tracing analysis and with an estimated high/very high individual risk of stroke, accounting for the anticipated net clinical benefit, and informed patient's preferences. Two randomized clinical trials on this topic are currently ongoing and are likely to better define the role of anticoagulant therapy in patients with AHREs.

2020 - ‘Real-world’ observational studies in arrhythmia research: data sources, methodology, and interpretation. A position document from European Heart Rhythm Association (EHRA), endorsed by Heart Rhythm Society (HRS), Asia-Pacific HRS (APHRS), and Latin America HRS (LAHRS) [Articolo su rivista]
Torp-Pedersen, Christian; Goette, Andreas; Nielsen, Peter Bronnum; Potpara, Tatjana; Fauchier, Laurent; John Camm, Alan; Arbelo, Elena; Boriani, Giuseppe; Skjoeth, Flemming; Rumsfeld, John; Masoudi, Frederick; Guo, Yutao; Joung, Boyoung; Refaat, Marwan M; Kim, Young-Hoon; Albert, Christine M; Piccini, Jonathan; Avezum, Alvaro; Lip, Gregory Y H; Gorenek, Bulent; Dagres, Nikolaos; Violi, Francesco; Du, Xin; Akao, Masaharu; Choi, Eue-Keun; Lopes, Renato D; Ozcan, Evren Emin; Lane, Deirdre; Marin, Francisco; Gale, Christopher Peter; Vernooy, Kevin; Kudaiberdieva, Gulmira; Kutyifa, Valentina; Traykov, Vassil B; Guevara, Carolina; Chao, Tze-Fan; Al-Khatib, Sana M
abstract

2019 - 2017 Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing [Articolo su rivista]
Stabile, G.; Bertaglia, E.; Guerra, F.; Palmisano, P.; Berisso, M. Z.; Soldati, E.; Bisignani, G.; Forleo, G. B.; Zanotto, G.; Landolina, M.; De Ponti, R.; Boriani, G.; Ricci, R. P.
abstract

Background. This report describes the findings of the 2017 Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC). Methods. Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers. Results. A total of 15 601 ablation procedures were performed by 91 institutions, with a mean of 184 ± 213 procedures per center. The most frequently treated arrhythmia was atrial fibrillation (34%), followed by atrioventricular nodal reentrant tachycardia (25%) and common atrial flutter (14%). About 10% of overall ablation procedures were performed in patients with ventricular arrhythmias. On-site cardiothoracic surgery was available in 42% of the centers performing ablation and in 49% of the centers performing atrial fibrillation ablation. In most patients, the ablation procedure was guided by a three-dimensional mapping system, and in 15% of patients a near-zero X-ray strategy was used. Conclusions. The Italian Catheter Ablation Registry systematically collected 1-year data on ablation procedures performed in Italy, revealing that atrial fibrillation is the most commonly treated arrhythmia in the ablation centers with an increasing number of patients treated for ventricular tachycardia.

2019 - Association between antithrombotic treatment and outcomes at 1-year follow-up in patients with atrial fibrillation: The EORP-AF General Long-Term Registry [Articolo su rivista]
Boriani, G.; Proietti, M.; Laroche, C.; Fauchier, L.; Marin, F.; Nabauer, M.; Potpara, T.; Dan, G. -A.; Kalarus, Z.; Tavazzi, L.; Maggioni, A. P.; Lip, G. Y. H.
abstract

Aims: In recent years, stroke prevention in patients with atrial fibrillation (AF) has radically changed, with increasing use of non-vitamin K antagonist oral anticoagulants (NOACs). Contemporary European data on AF thromboprophylaxis are needed. Methods and results: We report 1-year follow-up data from the EURObservational Research Programme in Atrial Fibrillation (EORP-AF) General Long-Term Registry. Outcomes were assessed according to antithrombotic therapy. At 1-year follow-up, 9663 (88.0%) patients had available data for analysis: 586 (6.1%) were not treated with any antithrombotic; 681 (7.0%) with antiplatelets only; 4066 (42.1%) with vitamin K antagonist (VKA) only; 3167 (32.8%) with NOACs only; and 1163 (12.0%) with antiplatelet and oral anticoagulant. At 1-year follow-up, there was a low rate of stroke (0.7%) and any thromboembolic event (TE) (1.2%), while haemorrhagic events occurred in 222 patients (2.3%). Cardiovascular (CV) death and all-cause death occurred in 3.9% and 5.2% of patients, respectively. Cumulative survival for all the three main outcomes considered was highest amongst patients treated only with NOACs (P < 0.0001). Multivariable-adjusted Cox regression analysis found that VKA or NOACs use was independently associated with a lower risk for any TE/acute coronary syndrome/CV death, while all treatments were independently associated with a lower risk for CV death and all-cause death. Conclusion: The 1-year follow-up of EORP-AF General Long-Term Registry reported a low occurrence of thromboembolic and haemorrhagic events, although mortality was high. Both VKA and NOACs were associated with a lower risk of all main adverse outcomes. All treatments were associated with a lower risk for CV death and all-cause death.

2019 - Atrial fibrillation in patients with active malignancy and use of anticoagulants: Under-prescription but no adverse impact on all-cause mortality [Articolo su rivista]
Malavasi, Vincenzo Livio; Fantecchi, Elisa; Gianolio, Laura; Pesce, Francesca; Longo, Giuseppe; Marietta, Marco; Cascinu, Stefano; Lip, Gregory Y. H.; Boriani, Giuseppe
abstract

Prescription of anticoagulants (ACs) in patients with cancer and atrial fibrillation (AF) is challenging and the impact on survival is not defined. In this study data prospectively collected in Oncology Units were retrospectively evaluated. Among 4664 patients admitted for malignancy, 394 patients (8.4%) had documented AF (mean age of 74 ± 9) and AC was prescribed to 155 patients (40%). Neither the type of cancer, the stage of the disease (metastatic or not) nor the ongoing treatments were significantly associated with prescription of AC, which was independently associated with BMI (OR 1.10; CI 95% 1.03–1.17; p =.003), valvular heart disease (OR 3.76; CI95% 1.59–8.87; p =.002), and previous venous thromboembolism (OR 6.67; 95%CI 2.67–16.70; p <.001). During a median follow-up of 212 days, survival from all-cause death was 37%, 28% and 18% at 6 months, 1 and 2 years, respectively. Only variables related to neoplastic disease or to patient clinical complexity were independently associated with mortality. A CHA2DS2VASc ≥ 4 was significantly associated with mortality (HR 1.33; 95%CI 1.06–1.67; p =.013). Treatment with ACs was not significantly related to mortality, neither in the whole cohort of patients, nor in patients with metastatic malignancies. In conclusion the prescription of ACs in patients with AF and active cancer was suboptimal, with one fourth of the patients not treated with ACs and one third using LMWH at prophylactic, non-therapeutic doses. Only few variables (BMI, valvular heart disease and previous venous thromboembolism) predicted prescription of ACs. Prescription of ACs was not associated with all-cause mortality, even in the subgroup with metastasis.

2019 - Atrial fibrillation in patients with cardiac implantable electronic devices: New perspectives with important clinical implications [Articolo su rivista]
Boriani, G.; Vitolo, M.
abstract

2019 - Atrial high rate episodes in patients with cardiac implantable electronic devices: implications for clinical outcomes [Articolo su rivista]
Miyazawa, K.; Pastori, D.; Li, Y. -G.; Szekely, O.; Shahid, F.; Boriani, G.; Lip, G. Y. H.
abstract

Background: Atrial high rate episodes (AHREs) detected by cardiac implantable electronic devices (CIEDs) are associated with an increased risk of stroke. However, the impact of AHRE on improving stroke risk stratification scheme remains uncertain. Objective: The purpose of this study was to assess the impact of AHRE on prognosis in relation with cardiovascular events and risk stratification. Methods: A total of 856 consecutive patients who had dual-chamber CIEDs implanted were retrospectively analyzed. To detect AHREs, they were monitored for 6 months after CIEDs’ implantation and were followed for a mean of 4.0 years for clinical outcomes such as thromboembolism or death. Results: Overall, 125 (14.6%) of patients developed AHREs within the first 6 months (median age 72.0 years, 39.3% female). Patients with AHREs had a high rate of thromboembolism (2.6%/year) and mortality (3.0%/year). On multivariate analysis, AHRE was significantly associated with increased risk of thromboembolism [hazard ratio (HR) 3.40; 95% confidence interval (CI) 1.38–8.37, P = 0.01] and death (HR 3.47; 95% CI 1.51–7.95; P < 0.01). The predictive abilities of the CHADS2 and CHA2DS2-VASc scores were modest, with no significant improvements by adding AHRE to those scores. However, the integrated discrimination improvement and net reclassification improvement showed that the addition of AHRE to the CHADS2 and CHA2DS2-VASc scores statistically improved their predictive ability for the composite outcome. Conclusions: AHRE was an independent factor associated with increased risk of clinical outcomes. The addition of AHRE to the clinical risk scores significantly improved discrimination for thromboembolism or death.

2019 - CHRONIC KIDNEY DISEASE AND ARRHYTHMIAS: CONCLUSIONS FROM A KIDNEY DISEASE: IMPROVING GLOBAL OUTCOMES (KDIGO) CONTROVERSIES CONFERENCE [Articolo su rivista]
Turakhia, M. P.; Blankestijn, P. J.; Carrero, J. -J.; Clase, C. M.; Deo, R.; Herzog, C. A.; Kasner, S. E.; Passman, R. S.; Pecoits-Filho, R.; Reinecke, H.; Shroff, G. R.; Zareba, W.; Cheung, M.; Wheeler, D. C.; Winkelmayer, W. C.; Wanner, C.; Amann, K.; Banerjee, D.; Bansal, N.; Boriani, G.; Bunch, J.; Chan, C. T.; Charytan, D. M.; Conen, D.; Friedman, A. N.; Genovesi, S.; Holden, R. M.; House, A. A.; Jadoul, M.; Jar-Dine, A. G.; Johnson, D. W.; Jun, M.; Labriola, L.; Mark, P. B.; Mccullough, P. A.; Nolin, T. D.; Potpara, T. S.; Pun, P. H.; Ribeiro, A. L. P.; Rossignol, P.; Shen, J. I.; Sood, M. M.; Tsukamoto, Y.; Yee-Moon Wang, A.; Weir, M. R.; Wetmore, J. B.; Wranicz, J. K.; Yamasaki, H.
abstract

Patients with chronic kidney disease (CKD) are predisposed to heart rhythm disorders, including atrial fibrillation (AF)/atrial flutter, supraventricular tachycardias, ventricular arrhythmias, and sudden cardiac death (SCD). While treatment options, including drug, device, and procedural therapies, are available, their use in the setting of CKD is complex and limited. Patients with CKD and end-stage kidney disease have historically been under-represented or excluded from randomized trials of arrhythmia treatment strategies, 1 although this situation is changing. Cardiovascular society consensus documents have recently identified evidence gaps for treating patients with CKD and heart rhythm disorders. To identify key issues relevant to the optimal prevention, management, and treatment of arrhythmias and their complications in patients with kidney disease, Kidney Disease: Improving Global Outcomes (KDIGO) convened an international, multidisciplinary Controversies Conference in Berlin, Germany, titled CKD and Arrhythmias in October 2016.

2019 - Cancer and atrial fibrillation. Author's reply [Articolo su rivista]
Malavasi, V. L.; Marietta, M.; Lip, G. Y. H.; Boriani, G.
abstract

2019 - Cardiac arrhythmias in the emergency settings of acute coronary syndrome and revascularization: An European Heart Rhythm Association (EHRA) consensus document, endorsed by the European Association of Percutaneous Cardiovascular Interventions (EAPCI), and European Acute Cardiovascular Care Association (ACCA) [Articolo su rivista]
Kalarus, Z.; Svendsen, J. H.; Capodanno, D.; Dan, G. -A.; De Maria, E.; Gorenek, B.; Jedrzejczyk-Patej, E.; Mazurek, M.; Podolecki, T.; Sticherling, C.; Tfelt-Hansen, J.; Traykov, V.; Lip, G. Y. H.; Fauchier, L.; Boriani, G.; Mansourati, J.; Blomstrom-Lundqvist, C.; Mairesse, G. H.; Rubboli, A.; Deneke, T.; Dagres, N.; Steen, T.; Ahrens, I.; Kunadian, V.; Berti, S.
abstract

Despite major therapeutic advances over the last decades, complex supraventricular and ventricular arrhythmias (VAs), particularly in the emergency setting or during revascularization for acute myocardial infarction (AMI), remain an important clinical problem. Although the incidence of VAs has declined in the hospital phase of acute coronary syndromes (ACS), mainly due to prompt revascularization and optimal medical therapy, still up to 6% patients with ACS develop ventricular tachycardia and/or ventricular fibrillation within the first hours of ACS symptoms. Despite sustained VAs being perceived predictors of worse in-hospital outcomes, specific associations between the type of VAs, arrhythmia timing, applied treatment strategies and long-term prognosis in AMI are vague. Atrial fibrillation (AF) is the most common supraventricular tachyarrhythmia that may be asymptomatic and/or may be associated with rapid haemodynamic deterioration requiring immediate treatment. It is estimated that over 20% AMI patients may have a history of AF, whereas the new-onset arrhythmia may occur in 5% patients with ST elevation myocardial infarction. Importantly, patients who were treated with primary percutaneous coronary intervention for AMI and developed AF have higher rates of adverse events and mortality compared with subjects free of arrhythmia. The scope of this position document is to cover the clinical implications and pharmacological/non-pharmacological management of arrhythmias in emergency presentations and during revascularization. Current evidence for clinical relevance of specific types of VAs complicating AMI in relation to arrhythmia timing has been discussed.

2019 - Cardiac resynchronization therapy: Need to synchronize patients and device longevities with comorbidities [Articolo su rivista]
Boriani, G.; Vitolo, M.; Kutyifa, V.
abstract

2019 - Cardiomyopathy associated with long-term right ventricular pacing: an intriguing clinical issue [Articolo su rivista]
Boriani, G.; Vitolo, M.; Proietti, M.
abstract

2019 - Clinical and organizational management of cardiac implantable electronic device replacements: An Italian Survey promoted by AIAC (Italian Association of Arrhythmology and Cardiac Pacing) [Articolo su rivista]
Palmisano, P.; Ziacchi, M.; Belotti, G.; Rapacciuolo, A.; Santini, L.; Stabile, G.; Zoni Berisso, M.; De Ponti, R.; Landolina, M.; Ricci, R. P.; Boriani, G.
abstract

AimsThe aim of this survey was to assess the management and organization of cardiac implantable electronic device (CIED) replacement in Italy.MethodsA questionnaire consisting of 24 questions on organizational aspects and on the peri-procedural management of anticoagulant therapies and antibiotic prophylaxis was sent via the Internet to 154 Italian arrhythmia centers.ResultsA total of 103 out of 154 centers completed the questionnaire (67% response rate). In 43% of the centers, the procedures were performed under day-case admission, in 40% under ordinary admission, and in 17% under either day-case or ordinary admission. The most frequent reason (66%) for choosing ordinary admission rather than day-case admission was to obtain full reimbursement. Although warfarin therapy was continued in 73% of the centers, nonvitamin K oral anticoagulants were discontinued, without bridging, 24h or less prior to replacement procedures in 88%. Prophylactic antibiotic therapy was systematically administered in all centers; in 97%, the first antibiotic dose was administered 1-2h prior to procedures. Local antibacterial envelopes were also used in 43% of the centers in patients with a higher risk of device infection.ConclusionThis survey provides a representative picture of how CIED replacements are organized and managed in current Italian clinical practice. The choice of the type of hospitalization (short versus ordinary) was more often motivated by economic reasons (reimbursement of the procedure) than by clinical and organizational factors. Peri-procedural management of anticoagulation and prophylactic antibiotic therapy was consistent with current scientific evidence.

2019 - Clinical characteristics of heart failure patients undergoing atrial fibrillation ablation today in Europe. Data from the atrial fibrillation registries of the European Society of Cardiology and the European Heart Rhythm Association [Articolo su rivista]
Temporelli, P. L.; Tilz, R. R.; Arbelo, E.; Dagres, N.; Laroche, C.; Crijns, H. J.; Blomstrom-Lundqvist, C.; Kirchhof, P.; Lip, G. Y. H.; Boriani, G.; Pokushalov, E.; Nakou, E.; Brugada, J.; Tavazzi, L.
abstract

2019 - Clinical practice and implementation of guidelines for the prevention, diagnosis and management of cardiac implantable electronic device infections: results of a worldwide survey under the auspices of the European Heart Rhythm Association [Articolo su rivista]
Traykov, V.; Bongiorni, M. G.; Boriani, G.; Burri, H.; Costa, R.; Dagres, N.; Deharo, J. -C.; Epstein, L. M.; Erba, P. A.; Snygg-Martin, U.; Nielsen, J. C.; Poole, J. E.; Saghy, L.; Starck, C.; Strathmore, N.; Blomstrom-Lundqvist, C.
abstract

AIMS: Cardiac implantable electronic device (CIED) infection rates are increasing. Worldwide compliance and disparities to published guidelines for the prevention, diagnosis and management of these conditions are not well elucidated. The purpose of this survey, therefore, was to clarify these issues through an inquiry to arrhythmia-related associations and societies worldwide. METHODS AND RESULTS: A questionnaire comprising 15 questions related to CIED infections was distributed among members of seven arrhythmia societies worldwide. A total of 234 centres in 62 countries reported implantation rates of which 159 (68.0%) performed more than 200 device implantations per year and 14 (6.0%) performed fewer than 50 implantations per year. The reported rates of CIED infections for 2017 were ≤2% in 78.7% of the centres, while the infection rates exceeded 5% in 7.8% of the centres. Preventive measures for CIED infection differed from published recommendations and varied among different regions mainly in terms of pocket irrigation and administering post-operative antimicrobial therapy the use of which was reported by 39.9% and 44% of the respondents, respectively. Antibacterial envelopes were used by 37.7% of the respondents in selected circumstances. In terms of pocket infection management, 62% of the respondents applied complete system removal as an initial step. Diagnostic pocket needle aspiration and pocket surgical debridement were reported by 15.8% and 11.8% of centres, respectively. CONCLUSION: Clinical practices for prevention and management of CIED do not fully comply with current recommendations and demonstrate considerable regional disparities. Further education and programmes for improved implementation of guidelines are mandatory.

2019 - Contribution of PET imaging to mortality risk stratification in candidates to lead extraction for pacemaker or defibrillator infection: a prospective single center study [Articolo su rivista]
Diemberger, Igor; Bonfiglioli, Rachele; Martignani, Cristian; Graziosi, Maddalena; Biffi, Mauro; Lorenzetti, Stefano; Ziacchi, Matteo; Nanni, Cristina; Fanti, Stefano; Boriani, Giuseppe
abstract

Purpose: 18F-FDG PET/CT is an emerging technique for diagnosis of cardiac implantable electronic devices infection (CIEDI). Despite the improvements in transvenous lead extraction (TLE), long-term survival in patients with CIEDI is poor. The aim of the present study was to evaluate whether the extension of CIEDI at 18F-FDG PET/CT can improve prediction of survival after TLE. Methods: Prospective, monocentric observational study enrolling consecutive candidates to TLE for a diagnosis of CIEDI. 18F-FDG PET/CT was performed in all patients prior TLE. Results: There were 105 consecutive patients with confirmed CIEDI enrolled. An increased 18F-FDG uptake was limited to cardiac implantable electrical device (CIED) pocket in 56 patients, 40 patients had a systemic involvement. We had nine negative PET in patients undergoing prolonged antimicrobial therapy (22.5 ± 14.0 days vs. 8.6 ± 13.0 days; p = 0.005). Implementation of 18F-FDG PET/CT in modified Duke Criteria lead to reclassification of 23.8% of the patients. After a mean follow-up of 25.0 ± 9.0 months, 31 patients died (29.5%). Patients with CIED pocket involvement at 18F-FDG PET/CT presented a better survival independently of presence/absence of systemic involvement (HR 0.493, 95%CI 0.240–0.984; p = 0.048). After integration of 18F-FDG PET/CT data, absence of overt/hidden pocket involvement in CIEDI and a (glomerular filtration rate) GFR < 60 ml/min were the only independent predictors of mortality at long term. Conclusions: Patient with CIEDI and a Cold Closed Pocket (i.e., a CIED pocket without skin erosion/perforation nor increased capitation at 18F-FDG PET/CT) present worse long-term survival. Patient management can benefit by systematic adoption of pre-TLE 18F-FDG PET/CT through improved identification of CIED related endocarditis (CIEDIE) and hidden involvement of CIED pocket.

2019 - Corrected QT interval prolongation in psychopharmacological treatment and its modulation by genetic variation [Articolo su rivista]
Corponi, F.; Fabbri, C.; Boriani, G.; Diemberger, I.; Albani, D.; Forloni, G.; Serretti, A.
abstract

Several antipsychotics and antidepressants have been associated with electrocardiogram alterations, the most clinically relevant of which is the heart rate-corrected QT interval (QT c ) prolongation, a risk factor for sudden cardiac death. Genetic variants influence drug-induced QT c prolongation and can provide valuable information for precision medicine. The effect of genetic variants on QT c prolongation as well as the possible interaction between polymorphisms and risk medications in determining QT c prolongation were investigated. Medications were classified according to their known risk of inducing QT c prolongation (high-to-moderate, low, and no risk). QT c duration and risk of QT c > median value were investigated in a sample of 77 patients with mood or psychotic disorders being treated with antidepressants and antipsychotics, and who had at least 1 ECG recording. A secondary analysis considered QT c percentage change in patients (n = 25) with 2 ECG recordings. Single-nucleotide polymorphisms previously associated with QT c prolongation during treatment with psychotropic medications were investigated. No association survived after multiple-testing correction. The best results for modulation of QT c duration were identified for rs10808071 (the ABCB1 gene, nominal p = 0.007) when at least 1 medication with a moderate-to-high risk was prescribed, and for rs12029454 (the NOS1AP gene) in patients taking at least 1 medication with a cardiovascular risk (nominal p = 0.008). In the secondary analysis, rs2072413 (the KCNH2 gene) was the top finding for the modulation of QT c percentage change (nominal p = 0.001) when 1 drug with a moderate-to-high risk was added compared to baseline. Despite the limited power of this study, our results suggest that ABCB1, NOS1AP, and KCNH2 may play a role in QT c duration/prolongation during treatment with psychotropic drugs.

2019 - Differences in cardiac phenotype and natural history of laminopathies with and without neuromuscular onset [Articolo su rivista]
Ditaranto, R.; Boriani, G.; Biffi, M.; Lorenzini, M.; Graziosi, M.; Ziacchi, M.; Pasquale, F.; Vitale, G.; Berardini, A.; Rinaldi, R.; Lattanzi, G.; Potena, L.; Martin Suarez, S.; Bacchi Reggiani, M. L.; Rapezzi, C.; Biagini, E.
abstract

Objective: To investigate differences in cardiac manifestations of patients affected by laminopathy, according to the presence or absence of neuromuscular involvement at presentation. Methods: We prospectively analyzed 40 consecutive patients with a diagnosis of laminopathy followed at a single centre between 1998 and 2017. Additionally, reports of clinical evaluations and tests prior to referral at our centre were retrospectively evaluated. Results: Clinical onset was cardiac in 26 cases and neuromuscular in 14. Patients with neuromuscular presentation experienced first symptoms earlier in life (11 vs 39 years; p < 0.0001) and developed atrial fibrillation/flutter (AF) and required pacemaker implantation at a younger age (28 vs 41 years [p = 0.013] and 30 vs 44 years [p = 0.086] respectively), despite a similar overall prevalence of AF (57% vs 65%; p = 0.735) and atrio-ventricular (A-V) block (50% vs 65%; p = 0.500). Those with a neuromuscular presentation developed a cardiomyopathy less frequently (43% vs 73%; p = 0.089) and had a lower rate of sustained ventricular tachyarrhythmias (7% vs 23%; p = 0.387). In patients with neuromuscular onset rhythm disturbances occurred usually before evidence of cardiomyopathy. Despite these differences, the need for heart transplantation and median age at intervention were similar in the two groups (29% vs 23% [p = 0.717] and 43 vs 46 years [p = 0.593] respectively). Conclusions: In patients with laminopathy, the type of disease onset was a marker for a different natural history. Specifically, patients with neuromuscular presentation had an earlier cardiac involvement, characterized by a linear and progressive evolution from rhythm disorders (AF and/or A-V block) to cardiomyopathy.

2019 - Direct oral anticoagulants vs non-vitamin K antagonist in atrial fibrillation: A prospective, propensity score adjusted cohort study [Articolo su rivista]
Marietta, M.; Banchelli, F.; Pavesi, P.; Manotti, C.; Quintavalla, R.; Sinigaglia, T.; Guazzaloca, G.; Pattacini, C.; Urbinati, S.; Malavasi, V. L.; Boriani, G.; Voci, C.; D'Amico, R.; Magrini, N.
abstract

2019 - EHRA White Paper: Knowledge gaps in arrhythmia management - Status 2019 [Articolo su rivista]
Goette, A.; Auricchio, A.; Boriani, G.; Braunschweig, F.; Terradellas, J. B.; Burri, H.; Camm, A. J.; Crijns, H.; Dagres, N.; Deharo, J. -C.; Dobrev, D.; Hatala, R.; Hindricks, G.; Hohnloser, S. H.; Leclercq, C.; Lewalter, T.; Lip, G. Y. H.; Merino, J. L.; Mont, L.; Prinzen, F.; Proclemer, A.; Purerfellner, H.; Savelieva, I.; Schilling, R.; Steffel, J.; Van Gelder, I. C.; Zeppenfeld, K.; Zupan, I.; Heidbuchel, H.; Boveda, S.; Defaye, P.; Brignole, M.; Chun, J.; Guerra Ramos, J. M.; Fauchier, L.; Svendsen, J. H.; Traykov, V. B.; Heinzel, F. R.
abstract

Clinicians accept that there are many unknowns when we make diagnostic and therapeutic decisions. Acceptance of uncertainty is essential for the pursuit of the profession: bedside decisions must often be made on the basis of incomplete evidence. Over the years, physicians sometimes even do not realize anymore which the fundamental gaps in our knowledge are. As clinical scientists, however, we have to halt and consider what we do not know yet, and how we can move forward addressing those unknowns. The European Heart Rhythm Association (EHRA) believes that scanning the field of arrhythmia / cardiac electrophysiology to identify knowledge gaps which are not yet the subject of organized research, should be undertaken on a regular basis. Such a review (White Paper) should concentrate on research which is feasible, realistic, and clinically relevant, and should not deal with futuristic aspirations. It fits with the EHRA mission that these White Papers should be shared on a global basis in order to foster collaborative and needed research which will ultimately lead to better care for our patients. The present EHRA White Paper summarizes knowledge gaps in the management of atrial fibrillation, ventricular tachycardia/sudden death and heart failure.

2019 - Early or Delayed Cardioversion in Recent-Onset Atrial Fibrillation [Articolo su rivista]
Boriani, G; Biffi, M
abstract

To the Editor: Pluymaekers et al. (April 18 issue)(1) evaluated the occurrence of spontaneous cardioversion in patients with recent-onset (<36 hours) atrial fibrillation. The proposed wait-and-see approach included cardioversion within 48 hours in the absence of spontaneous resumption of sinus rhythm, and delayed cardioversion was actually necessary in 28% of the patients randomly assigned to this strategy. We think that the idea of waiting for spontaneous cardioversion of atrial fibrillation is interesting, but for practical reasons, better patient targeting would be required. In two previous prospective, randomized trials, we found that in patients with recent-onset atrial fibrillation, spontaneous cardioversion can . . .

2019 - Effect of PR interval and pacing mode on persistent atrial fibrillation incidence in dual chamber pacemaker patients: A sub-study of the international randomized MINERVA trial [Articolo su rivista]
Boriani, G.; Pieragnoli, P.; Botto, G. L.; Puererfellner, H.; Mont, L.; Ziacchi, M.; Manolis, A. S.; Gulizia, M.; Tukkie, R.; Landolina, M.; Ricciardi, G.; Cicconelli, M.; Grammatico, A.; Biffi, M.
abstract

Aims Per standard of care, dual-chamber pacemakers are programmed in DDDR mode with fixed atrioventricular (AV) delay or with long AV delay to minimize ventricular pacing. We aimed to evaluate whether the PR interval may be a specific criterion of choice between standard DDDR, to preserve AV synchrony in long PR patients, and managed ventricular pacing (MVP), to avoid ventricular desynchronization imposed by right ventricle apical pacing, in short PR patients. Methods and results In the MINERVA trial, 1166 patients were randomized to Control DDDR, MVP, or atrial anti-tachycardia pacing plus MVP (DDDRP + MVP). We evaluated the interaction of PR interval with pacing mode by comparing the risk of atrial fibrillation (AF) longer than 7 consecutive days as a function of PR interval. Out of 906 patients with available data, the median PR interval was 180 ms. The PR interval was found to significantly (P = 0.012) interact with pacing mode for AF incidence: The risk of AF > 7 days was lower [hazard ratio (HR) 0.58, 95% confidence interval (95% CI) 0.34-0.99; P = 0.047] in patients with short PR (shorter than median PR) if programmed in MVP mode compared with DDDR mode and it was lower (HR 0.65, 95% CI 0.43-0.99; P = 0.049) in patients with long PR (equal to or longer than median PR) if programmed in DDDR mode compared with MVP. Conclusion Our data show that PR interval may be used as a selection criterion to identify the optimal physiological pacing mode. Persistent AF incidence was lower in short PR patients treated by right ventricular pacing minimization and in long PR patients treated by standard dual-chamber pacing.

2019 - Effects of cardiac resynchronization therapy on right ventricular function during rest and exercise, as assessed by radionuclide angiography, and on NT-proBNP levels [Articolo su rivista]
Valzania, Cinzia; Biffi, Mauro; Bonfiglioli, Rachele; Fallani, Francesco; Martignani, Cristian; Diemberger, Igor; Ziacchi, Matteo; Frisoni, Jessica; Tomasi, Luciana; Fanti, Stefano; Rapezzi, Claudio; Boriani, Giuseppe
abstract

Aim: We carried out this study to investigate mid-term effects of cardiac resynchronization therapy (CRT) on right ventricular (RV) function and neurohormonal response, expressed by N-terminal pro-brain natriuretic peptide (NT-proBNP), in heart failure patients stratified by baseline RV ejection fraction (RVEF). Methods and Results: Thirty-six patients with nonischemic dilated cardiomyopathy underwent technetium-99m radionuclide angiography with bicycle exercise immediately after CRT implantation (during spontaneous rhythm and after CRT activation) and 3 months later. Plasma NT proBNP was assessed before implantation and after 3 months. At baseline, RVEF was impaired (≤35%) in 14 patients, preserved (>35%) in 22. At 3 months, RVEF improved during rest and exercise (P = .02) in patients with impaired RV function, while remaining unchanged in patients with preserved RV function. Rest and exercise RV dyssynchrony decreased in both groups at follow-up (P < .05). A similar mid-term improvement in left ventricular (LV) function and NT-proBNP was observed in patients with impaired and preserved RVEF. In the former, the decrease in NT-proBNP correlated with the improvements both in LV and RV dyssynchrony and functions. Conclusion: CRT may improve RV performance, during rest and exercise, and neurohormonal response in heart failure patients with nonischemic dilated cardiomyopathy and baseline RV dysfunction. RV dysfunction should not be considered per se a primary criterion for excluding candidacy to CRT.

2019 - European Heart Rhythm Association (EHRA) consensus document on management of arrhythmias and cardiac electronic devices in the critically ill and post-surgery patient, endorsed by endorsed by Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), Cardiac Arrhythmia Society of Southern Africa (CASSA), and Latin American Heart Rhythm Society (LAHRS) [Articolo su rivista]
Boriani, Giuseppe; Fauchier, Laurent; Aguinaga, Luis; Beattie, James M; Blomstrom Lundqvist, Carina; Cohen, Ariel; Dan, Gheorghe-Andrei; Genovesi, Simonetta; Israel, Carsten; Joung, Boyoung; Kalarus, Zbigniew; Lampert, Rachel; Malavasi, Vincenzo L; Mansourati, Jacques; Mont, Lluis; Potpara, Tatjana; Thornton, Andrew; Lip, Gregory Y H
abstract

NA

2019 - Favorable Trend of Implantable Cardioverter-Defibrillator Service Life in a Large Single-Nation Population: Insights From 10-Year Analysis of the Italian Implantable Cardioverter-Defibrillator Registry [Articolo su rivista]
Poli, S.; Boriani, G.; Zecchin, M.; Facchin, D.; Gasparini, M.; Landolina, M.; Ricci, R. P.; Lanera, C.; Gregori, D.; Proclemer, A.
abstract

Background: Implantable cardioverter-defibrillators (ICDs) are widely employed for the prevention of sudden cardiac death. Despite technological improvements, patients often need to undergo generator replacement, which entails the risk of periprocedural complications. Our aim was to estimate the service life of ICDs over a 10-year interval and to assess the main causes of replacement on the basis of data from the National ICD Registry of the Italian Society of Arrhythmology and Cardiac Pacing (AIAC). Methods and Results: The registry includes data from over 400 hospitals in Italy. We included all patients who underwent device replacement from calendar years 2007 to 2016. The median service life of the ICDs and its trend over the years was estimated across the 3 types of devices (single-chamber, dual-chamber, cardiac resynchronization therapy defibrillator) and the indication to implantation. The causes of replacement were also analyzed. We included 29 158 records from 27 676 patients (80.9% men; mean age at device replacement 65.8±12.0 years). The median service life was 57.3 months (interquartile range 27.8 months). Over the years, service life showed an increasing trend. The majority of patients underwent elective replacement because of battery end of life, and over the years there was a significant reduction of replacement for recalls, erosion/infections, and cardiac resynchronization therapy upgrading. Conclusions: Our data from a large single-nation population showed that the trend of ICD service life, independently from ICD type, indication, and settings, significantly improved over time. Moreover, there was a striking reduction of interventions for upgrading and infection/erosion. This favorable trend has important clinical, organizational, and financial implications.

2019 - Home care for heart failure: can caregiver education prevent hospital admissions? A randomized trial in primary care [Articolo su rivista]
Padula, Maria S; D'Ambrosio, Gaetano Giorgio; Tocci, Marina; D'Amico, Roberto; Banchelli, Federico; Angeli, Letizia; Scarpa, Marina; Capelli, Oreste; Cricelli, Claudio; Boriani, Giuseppe
abstract

To assess the feasibility and effectiveness of a low-complexity, low-cost model of caregiver education in primary care, targeted to reduce hospitalizations of heart failure patients.

2019 - Imaging functional stress test for stable chest pain symptoms in patients at low pretest probability of coronary artery disease: Current practice and long-term outcome [Articolo su rivista]
Gaibazzi, N.; Barbieri, A.; Boriani, G.; Benatti, G.; Codazzo, G.; Manicardi, M.; Bursi, F.; Siniscalchi, C.
abstract

Background: Stress testing in patients with low pretest probability (PTP) of coronary artery disease (CAD) has become an increasing practice, potentially leading to underestimation of its true clinical value. Our aim was to describe the current use of most employed imaging functional tests and their prognostic value. Methods and Results: We selected patients with low PTP of CAD (CAD consortium clinical score < 15%) who underwent exercise or dipyridamole stress echocardiography or single photon emission computed tomography for suspected angina. Main exclusions were age < 45, known CAD, and abnormal rest wall motion. Of the 2279 subjects undergoing stress test, 883 (39%) had low PTP, and 91 (10.3%) had a positive test for ischemia. After a median follow-up of 5.8 years, 36 patients had events (21 died, 14 had nonfatal myocardial infarction). The percentage of events in the abnormal and normal stress test groups were similar (5 [5.5%] vs 31 [3.9%], P = ns), as the annualized event rate (0.87% vs 0.62%, P = ns). Age was the only variable associated with outcome in the regression analysis (hazard ratio 1.072, 95% CI 1.034–1.113, P < 0.001). An abnormal result was not associated with worse outcome in each of the subgroups of functional tests. Conclusions: In our geographical area, a considerable proportion of patients undergoing imaging functional tests for stable chest pain have a low estimated PTP of CAD. Of these, 1 in 10 resulted positive for inducible ischemia. However, none of the most common imaging functional tests, single photon emission computed tomography (SPECT), and stress echocardiography offer prognostic information in these patients.

2019 - Impact of Body Mass Index on Outcomes in the Edoxaban Versus Warfarin Therapy Groups in Patients Underwent Cardioversion of Atrial Fibrillation (from ENSURE-AF) [Articolo su rivista]
Lip, Gregory Y H; Merino, Jose L; Banach, Maciej; de Groot, Joris R; Maier, Lars S; Themistoclakis, Sakis; Boriani, Giuseppe; Jin, James; Melino, Michael; Winters, Shannon M; Goette, Andreas
abstract

In the EdoxabaN versus warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation study (NCT 02072434), edoxaban showed similar efficacy and safety versus enoxaparin-warfarin in patients underwent electrical cardioversion of nonvalvular atrial fibrillation. In this ancillary analysis, we compared the primary efficacy (composite of stroke, systemic embolic event, myocardial infarction, cardiovascular death, and overall study period) and safety (composite of major and clinically relevant nonmajor bleeding, on-treatment) end points in relation to body mass index (BMI; <30 vs ≥30 kg/m2). We also compared cardioversion outcomes in relation to BMI. Of 2,199 patients enrolled, 1,095 were randomized to edoxaban and 1,104 to enoxaparin-warfarin. Mean age was 64 ± 10 and 64 ± 11 years and mean BMI 30.6 and 30.7 kg/m2, respectively. Cardiovascular and metabolic diseases were more prevalent in obese (n = 1067) than nonobese patients. Overall ischemic event rates were low; rates in the BMI <30 kg/m2 subgroup were numerically lower than the ≥30 kg/m2 subgroup, but not significantly different (odds ratio [OR], 0.74 [95% confidence interval 0.23, 2.24]). Composite major + clinically relevant nonmajor bleeding rates were low and numerically lower, but not significantly different (OR 0.88 [0.38, 2.04]), between the edoxaban and enoxaparin-warfarin arms and across weight categories. Successful cardioversion rate was higher in the BMI <30 versus ≥30 kg/m2 subgroup (73.9% vs 69.9%; OR 1.22 [1.01 to 1.48]). In EdoxabaN versus warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation, BMI did not significantly impact the relative efficacy and safety of edoxaban versus enoxaparin-warfarin. Nevertheless, the nonobese group had a higher rate of cardioversion success than the obese group.

2019 - Infective endocarditis in patients with cardiac implantable electronic devices: Impact of comorbidities on outcome [Articolo su rivista]
Diemberger, I.; Lorenzetti, S.; Vitolo, M.; Boriani, G.
abstract

2019 - International longitudinal registry of patients with atrial fibrillation and treated with rivaroxaban: RIVaroxaban Evaluation in Real life setting (RIVER) [Articolo su rivista]
Beyer-Westendorf, J.; Camm, A. J.; Fox, K. A. A.; Le Heuzey, J. -Y.; Haas, S.; Turpie, A. G. G.; Virdone, S.; Kakkar, A. K.; Pieper, K. S.; Kayani, G.; Gersh, B. J.; Hildebrandt, P.; Dominguez, H.; Comuth, W.; Frost, L.; Moller, D. S.; Christensen, H.; Bruun, L. M.; Milhem, A.; Gauthier, J.; Mielot, C.; Chanseaume, S.; Chopra, S.; Amlaiky, A.; Tricot, O.; Sierra, V.; Dompnier, A.; Zannad, N.; Pinzani, A.; Quatre, A.; Mansourati, J.; Fauchier, L.; Badenco, N.; Gandjbakhch, E.; Chachoua, K. F.; Malquarti, V.; Pierron, F.; Sacher, F.; Taieb, J.; Davy, J. M.; Marijon, E.; Lellouche, N.; Leenhardt, A.; Salem, A.; Lesto, I.; Muller, J. J.; Garcia, R.; Neau, J. P.; Berneau, J. B.; Schon, N.; Gulba, D.; Appel, K. F.; Merke, J.; Dshabrailov, J.; Bauknecht, C.; Scheuermann, O.; Schroder, T.; Jung, W.; Kopf, A.; Brachmann, J.; Leschke, M.; Taggeselle, J.; Seige, M.; Lassig, T.; Appel, S.; Schmiedl, M.; Muller, K.; Heinz, G. U.; Axthelm, C.; Eberhard, K.; Hugl, B.; Schwarz, T.; Sechtem, U.; Falanga, A.; Rubino, V.; Calo, L.; Ageno, W.; Massari, F.; Imberti, D.; Di Gennaro, L.; Gaita, F.; Margonato, A.; Cannava, G.; Capasso, F.; Diemberger, I.; Pelliccia, F.; Cafolla, A.; Bardari, S.; Mattei, L.; Ruocco, L.; Boriani, G.; Poli, D.; Testa, S.; Indolfi, C.; Quintavalla, R.; Mos, L.; Ladyjanskaia, G.; Aksoy, I.; Van De Wetering, M.; Theunissen, L.; Den Hartog, F.; Nijmeijer, R.; Van De Wal, R.; Reinders, S.; Patterson, M.; Melker, E. D.; Troquay, R.; Korecki, J.; Szyszka, A.; Diks, F.; Sumis, J.; Cygler, J.; Miklaszewicz, B.; Litwiejko-Pietrynczak, E.; Napora, P.; Drelich, G.; Kawka-Urbanek, T.; Wranicz, J. K.; Mierzejewski, M.; Drzewiecka, A.; Wronska, D.; Fares, I.; Baska, J.; Stania, K.; Krzyzanowski, W.; Miekus, P.; Tyminski, M.; Dronov, D.; Zenin, S.; Isaeva, E.; Lopukhov, A.; Yakusevich, V.; Kuznetsov, D.; Kameneva, T.; Pokushalov, E.; Karetnikova, V.; Dik, I.; Karpushina, I.; Nikolin, D.; Doletsky, A.; Ardashev, A.; Timofeeva, A.; Miller, O.; Lyamina, N.; Shubik, Y.; Boldueva, S.; Blanco Coronado, J. L.; Gonzalez Juanatey, C.; Otero, E.; Alonso, D.; Torres Llergo, J.; Gonzalez Lama, J.; De Prada Tiffe, J. A. V.; Garcia Seara, F. J.; Gomez Doblas, J. J.; Riancho, J. A.; Clua-Espuny, J. L.; Motero, J.; Arrarte, V. I.; Martin Raymondi, D.; Isasti Aizpurua, G.; Marin, F.; Nieto, J. A.; Fernandez Portales, J.; Alvarez Garcia, P.; Torstensson, I.; Cederin, B.; Kalm, T.; Rosenqvist, U.; Thulin, J.; Hajimirsadeghi, A.; Crisby, M.; Manoj, A.; Bakhai, A.; Mistri, A.; Krishnan, M.; Kumar, S.; Kirubakaran, S.; Thomas, H.; Camm, J.; Ahmed, F.; Ross, A. M.; Barry, K.; Stockwell, R.; Broadley, A.; Mamun, M.; Chatterjee, K.; Cooke, J.; Mccready, J.; Dutta, D.; John, K.; Pandya, P.; Howlett, R.; Vinson, P.; Lim, ; Foley, P.; Bruce, D.; Dixit, A.; Broughton, D.; Taylor, J.; Schilling, R.; Leon, K.; Saeed, K.; Shaheen, S.; Tawfik, M.; Mortadda, A.; Seleem, M.; Aly, M. S. I.; Kazamel, G.; Elbadry, M.; Kamal, S.; Hassan, M.; Mostafa, M.; Medhat, M. E. S.; Ekhlas, ; Ghaleb, R.; Taha, M. O.; Daoud, I.; Al Din, H.; Imam, A. M.; El Hameed, M. A.; Helmy, ; Al-Murayeh, M.; Akhtar, N.; Matto, B. M.; Ghani, M. A.; Amoudi, O. A.; Morsy, M. M.; Bashir, A. A. F.; Al Hossni, Y. M.; Al Ghamdi, B.; Zia-Ul-Sabah, ; Mir, S.; Dardir, D.; Masswary, A.; Al Shehri, A. R.; Masswary, A.; Iqbal, J.; Almansori, M. A. J.; Venkitachalam, C. G.; Kurian, J.; Rao, J.; Aisheh, A.; Albawab, A. A.; Subbaraman, B.; Amanat, A.; Esfehani, K. J.; Lochan, R.; Bin Brek, A.; Mittal, B.; Ghazi, Y.; Krishna, M.; Tabatabaei, S. B.; Thoppil, P. S.; Nasim, S.; El Khider Nour, S.; Barros, P.; Almeida, A. P.; Andrade, M.; Garbelini, B.; Silvestrini, T. L.; Alves, A. R.; De Lima, C. E. B.; Kormann, A.; De Lima, G. G.; Halperin, C.; Salvadori Junior, D.; Freitas, A. F.; Gemelli, J. R.; Ornelas, C. E.; Dantas, J. M. M.; Aziz, J. L.; Backes, L. M.; Barroso, W. S.; Paiva, M. S.; De Figueiredo Neto, J. A.; Dos Santos, F. R.; De Lima Neto, J. A.; Bergo, R.; Salvador Junior, P. R.; Lopez, A. G.; Alva, J. C. P.
abstract

Background: Real-world data on non-vitamin K oral anticoagulants (NOACs) are essential in determining whether evidence from randomised controlled clinical trials translate into meaningful clinical benefits for patients in everyday practice. RIVER (RIVaroxaban Evaluation in Real life setting) is an ongoing international, prospective registry of patients with newly diagnosed non-valvular atrial fibrillation (NVAF) and at least one investigator-determined risk factor for stroke who received rivaroxaban as an initial treatment for the prevention of thromboembolic stroke. The aim of this paper is to describe the design of the RIVER registry and baseline characteristics of patients with newly diagnosed NVAF who received rivaroxaban as an initial treatment. Methods and results: Between January 2014 and June 2017, RIVER investigators recruited 5072 patients at 309 centres in 17 countries. The aim was to enroll consecutive patients at sites where rivaroxaban was already routinely prescribed for stroke prevention. Each patient is being followed up prospectively for a minimum of 2-years. The registry will capture data on the rate and nature of all thromboembolic events (stroke / systemic embolism), bleeding complications, all-cause mortality and other major cardiovascular events as they occur. Data quality is assured through a combination of remote electronic monitoring and onsite monitoring (including source data verification in 10% of cases). Patients were mostly enrolled by cardiologists (n = 3776, 74.6%), by internal medicine specialists 14.2% (n = 718) and by primary care/general practice physicians 8.2% (n = 417). The mean (SD) age of the population was 69.5 (11.0) years, 44.3% were women. Mean (SD) CHADS2 score was 1.9 (1.2) and CHA2DS2-VASc scores was 3.2 (1.6). Almost all patients (98.5%) were prescribed with once daily dose of rivaroxaban, most commonly 20 mg (76.5%) and 15 mg (20.0%) as their initial treatment; 17.9% of patients received concomitant antiplatelet therapy. Most patients enrolled in RIVER met the recommended threshold for AC therapy (86.6% for 2012 ESC Guidelines, and 79.8% of patients according to 2016 ESC Guidelines). Conclusions: The RIVER prospective registry will expand our knowledge of how rivaroxaban is prescribed in everyday practice and whether evidence from clinical trials can be translated to the broader cross-section of patients in the real world.

2019 - Lead choice in cardiac implantable electronic devices: an Italian survey promoted by AIAC (Italian Association of Arrhythmias and Cardiac Pacing) [Articolo su rivista]
Ziacchi, M.; Palmisano, P.; Biffi, M.; Guerra, F.; Stabile, G.; Forleo, G. B.; Zanotto, G.; D'Onofrio, A.; Landolina, M.; De Ponti, R.; Zoni Berisso, M.; Ricci, R. P.; Boriani, G.
abstract

Background: Few data are available regarding lead preferences of electrophysiologists during cardiac implantable electronic devices (CIEDs) implantation. Aim of this survey is to evaluate the leads used, and the reasons behind these choices, in a large population of implanters. Methods: A questionnaire was sent to all 314 Italian centers with experience in CIED implantation. Results: 103 operators from 100 centers (32% of centers) responded. For atrium, passive leads represented first choice for pacemakers and defibrillators (71% and 64% of physicians, respectively), mainly for safety. For right ventricle, active fixation was preferred (61% and 93% operators in pacemaker and defibrillator patients), for higher versatility in positioning and lower dislodgement risk. For left ventricular stimulation, quadripolar leads were preferred by more than 80% of respondents, for better phrenic nerve and myocardial threshold management; active-fixation leads represent a second choice, in order to prevent or manage dislodgement (78% and 17% of respondents, respectively), but 44% of operators considered them dangerous. Conclusions: The choice of leads is heterogeneous. Trends are toward active-fixation right ventricular leads and passive-fixation atrial leads (particularly in pacemaker patients, considered frailer). For left ventricular stimulation, operators’ majority want to disposition all kind of leads, although quadripolar leads are the favorites.

2019 - Long-Term Implications of Atrial Fibrillation in Patients With Degenerative Mitral Regurgitation [Articolo su rivista]
Grigioni, F.; Benfari, G.; Vanoverschelde, J. -L.; Tribouilloy, C.; Avierinos, J. -F.; Bursi, F.; Suri, R. M.; Guerra, F.; Pasquet, A.; Rusinaru, D.; Marcelli, E.; Theron, A.; Barbieri, A.; Michelena, H.; Lazam, S.; Szymanski, C.; Nkomo, V. T.; Capucci, A.; Thapa, P.; Enriquez-Sarano, M.; for the MIDA Investigators Clavel, M. A.; Maalouf, J.; Trojette, F.; Szymanski, C.; Touati, G.; Remadi, J. P.; Russo, A.; Biagini, E.; Pasquale, F.; Ferlito, M.; Rapezzi, C.; Savini, C.; Marinelli, G.; Pacini, D.; Gargiulo, G. D.; Di Bartolomeo, R.; Boulif, J.; de Meester, C.; El Khoury, G.; Gerber, B.; Noirhomme, P.; Vancraeynest, D.; Collard, F.; Habib, G.; Mantovani, F.; Lugli, R.; Modena, M. G.; Boriani, G.; Bacchi-Reggiani, L.
abstract

Background: Scientific guidelines consider atrial fibrillation (AF) complicating degenerative mitral regurgitation (DMR) a debated indication for surgery. Objectives: This study analyzed the prognostic/therapeutic implications of AF at DMR diagnosis and long-term. Methods: Patients were enrolled in the MIDA (Mitral Regurgitation International Database) registry, which reported the consecutive, multicenter, international experience with DMR due to flail leaflets echocardiographically diagnosed. Results: Among 2,425 patients (age 67 ± 13 years; 71% male, 67% asymptomatic, ejection fraction 64 ± 10%), 1,646 presented at diagnosis with sinus rhythm (SR), 317 with paroxysmal AD, and 462 with persistent AF. Underlying clinical/instrumental characteristics progressively worsened from SR to paroxysmal to persistent AF. During follow-up, paroxysmal and persistent AF were associated with excess mortality (10-year survival in SR and in paroxysmal and persistent AF was 74 ± 1%, 59 ± 3%, and 46 ± 2%, respectively; p < 0.0001), that persisted 20 years post-diagnosis and independently of all baseline characteristics (p values <0.0001). Surgery (n = 1,889, repair 88%) was associated with better survival versus medical management, regardless of all baseline characteristics and rhythm (adjusted hazard ratio: 0.26; 95% confidence interval: 0.23 to 0.30; p < 0.0001) but post-surgical outcome remained affected by AF (10-year post-surgical survival in SR and in paroxysmal and persistent AF was 82 ± 1%, 70 ± 4%, and 57 ± 3%, respectively; p < 0.0001). Conclusions: AF is a frequent occurrence at DMR diagnosis. Although AF is associated with older age and more severe presentation of DMR, it is independently associated with excess mortality long-term after diagnosis. Surgery is followed by improved survival in each cardiac rhythm subset, but persistence of excess risk is observed for each type of AF. Our study indicates that detection of AF, even paroxysmal, should trigger prompt consideration for surgery.

2019 - Long-Term Relationship Between Atrial Fibrillation, Multimorbidity and Oral Anticoagulant Drug Use [Articolo su rivista]
Proietti, M.; Marzona, I.; Vannini, T.; Tettamanti, M.; Fortino, I.; Merlino, L.; Basili, S.; Mannucci, P. M.; Boriani, G.; Lip, G. Y. H.; Roncaglioni, M. C.; Nobili, A.
abstract

Objectives: To analyze the relationship between atrial fibrillation (AF) and Charlson comorbidity index (CCI) in a population-based cohort study over a long-term follow-up period, in relation to oral anticoagulant (OAC) prescriptions and outcomes. Patients and Methods: We used data from the administrative health databases of Lombardy. All patients with AF and age 40 years and older and who were admitted to the hospital in 2002 were considered for analysis and followed up to 2014. AF diagnosis and CCI were established according to codes from the International Classification of Diseases, Ninth Revision. Results: In 2002, 24,040 patients were admitted with a diagnosis of AF. CCI was higher in patients with AF than in those without AF (1.8±2.1 vs 0.2±0.9; P<.001). Over 12 years of follow-up, AF was associated with an increased risk of higher CCI (beta coefficient, 1.69; 95% CI, 1.67-1.70). In patients with AF, CCI was inversely associated with OAC prescription at baseline (P<.001) and at the end of the follow-up (P=.03). Patients with AF and a high CCI (≥4) had a higher cumulative incidence of stroke, major bleeding, and all-cause death (all P<.001), compared with those with low CCI (range, 0-3). Adjusted Cox regression analysis revealed that time-dependent continuous CCI was associated with an increased risk for stroke, major bleeding, and all-cause death (all P<.001). Conclusions: In hospitalized patients, AF is associated with an increase in CCI that is inversely associated with OAC prescriptions during follow-up. CCI is independently associated with an increased risk of stroke, major bleeding, and all-cause death.

2019 - Management of asymptomatic arrhythmias: a European Heart Rhythm Association (EHRA) consensus document, endorsed by the Heart Failure Association (HFA), Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), Cardiac Arrhythmia Society of Southern Africa (CASSA), and Latin America Heart Rhythm Society (LAHRS) [Articolo su rivista]
Arnar, David O; Mairesse, Georges H; Boriani, Giuseppe; Calkins, Hugh; Chin, Ashley; Coats, Andrew; Deharo, Jean-Claude; Svendsen, Jesper Hastrup; Heidbüchel, Hein; Isa, Rodrigo; Kalman, Jonathan M; Lane, Deirdre A; Louw, Ruan; Lip, Gregory Y H; Maury, Philippe; Potpara, Tatjana; Sacher, Frederic; Sanders, Prashanthan; Varma, Niraj; Fauchier, Laurent
abstract

Asymptomatic arrhythmias are frequently encountered in clinical practice. Although studies specifically dedicated to these asymptomatic arrhythmias are lacking, many arrhythmias still require proper diagnostic and prognostic evaluation and treatment to avoid severe consequences, such as stroke or systemic emboli, heart failure, or sudden cardiac death. The present document reviews the evidence, where available, and attempts to reach a consensus, where evidence is insufficient or conflicting.

2019 - Management of atrial fibrillation in the emergency room and in the cardiology ward: the BLITZ AF study [Articolo su rivista]
Gulizia, Michele Massimo; Cemin, Roberto; Colivicchi, Furio; De Luca, Leonardo; Di Lenarda, Andrea; Boriani, Giuseppe; Di Pasquale, Giuseppe; Nardi, Federico; Scherillo, Marino; Lucci, Donata; Fabbri, Gianna; Maggioni, Aldo Pietro
abstract

To assess the number of admissions to the emergency room (ER) of patients with atrial fibrillation (AF) or atrial flutter (af) and their subsequent management. To evaluate the clinical profile and the use of antithrombotics and antiarrhythmic therapy in patients with AF admitted to cardiology wards.

2019 - Nationwide survey on the current practice of ventricular tachycardia ablation [Articolo su rivista]
Vergara, P.; Casella, M.; Barbato, G.; De Ruvo, E.; Grandinetti, G.; Notarstefano, P.; Tola, G.; Calvi, V.; Santini, L.; Nissardi, V.; Nonis, A.; Ricci, R. P.; Boriani, G.; Tondo, C.; Della Bella, P.
abstract

MethodsWe performed a nationwide survey on the current practice of ventricular tachycardia catheter ablation in Italy during the year 2016.ResultsAmong 145 operators participating in the survey, 58 (40.0%) did not perform any ventricular tachycardia ablation in 2016. Among those performing ventricular tachycardia ablation, 9 operators (6.2%) performed only right ventricular endocardial catheter ablation, 52 (35.9%) performed endocardial catheter ablation both in the right and left ventricle (LV) and 26 (17.9%) performed both endocardial and epicardial LV catheter ablations. Seventy operators (89.7%) among the 78 performing LV and epicardial ablations treated patients with ischemic cardiomyopathy; ablations in the setting of other causes were less frequently performed. The following were considered as minimum requirements for ventricular tachycardia ablation: presence of a three-dimensional mapping system (120 operators, 82.8%), ICU in the hospital (118 operators, 81.4%), operator's training in high volume centers (93 operators, 64.1%). Twenty-eight operators (19.3%) performed catheter ablation in patients with electrical storm only after hemodynamic stabilization, 41 operators (28.3%) also during the acute phase and 9 operators (6.2%) never performed catheter ablation in electrical storm patients; the remaining 67 operators did not perform ventricular tachycardia ablation at all, or performed ablations only in the right ventricle.ConclusionThe present survey provides a snapshot of the current invasive treatment of ventricular tachycardia by catheter ablation. The procedure, especially in the setting of ischemic cardiomyopathy, is performed nationwide. Complex cases, including those with electrical storm, should be managed within a preestablished integrated network of regional referral centers able to transfer patients as soon as possible.

2019 - Neuro-arrhythmology: A challenging field of action and research: A review from the Task Force of Neuro-arrhythmology of Italian Association of Arrhythmias and Cardiac Pacing [Articolo su rivista]
Strano, S.; Toni, D.; Ammirati, F.; Sanna, T.; Tomaino, M.; Brignole, M.; Mazza, A.; Nguyen, B. L.; Di Bonaventura, C.; Ricci, R. P.; Boriani, G.
abstract

There is a growing interest in the study of the mechanisms of heart and brain interactions with the aim to improve the management of high-impact cardiac rhythm disorders, first of all atrial fibrillation. However, there are several topics to which the scientific interests of cardiologists and neurologists converge constituting the basis for enhancing the development of neuro-arrhythmology. This multidisciplinary field should cover a wide spectrum of diseases, even beyond the classical framework corresponding to stroke and atrial fibrillation and include the complex issues of seizures as well as loss of consciousness and syncope. The implications of a more focused interaction between neurologists and cardiologists in the field of neuro-arrhythmology should include in perspective the institution of research networks specifically devoted to investigate 'from bench to bedside' the complex pathophysiological links of the abovementioned diseases, with involvement of scientists in the field of biochemistry, genetics, molecular medicine, physiology, pathology and bioengineering. An investment in the field could have important implications in the perspectives of a more personalized approach to patients and diseases, in the context of 'precision'medicine. Large datasets and electronic medical records, with the approach typical of 'big data' could enhance the possibility of new findings with potentially important clinical implications. Finally, the interaction between neurologists and cardiologists involved in arrythmia management should have some organizational implications, with new models of healthcare delivery based on multidisciplinary assistance, similarly to that applied in the case of syncope units.

2019 - New classification of geometric patterns considering left ventricular volume in patients with chronic aortic valve regurgitation: Prevalence and association with adverse cardiovascular outcomes [Articolo su rivista]
Barbieri, Andrea; Giubertoni, Elisa; Bartolacelli, Ylenia; Bursi, Francesca; Manicardi, Marcella; Boriani, Giuseppe
abstract

Background: Left ventricular (LV) remodeling due to aortic regurgitation (AR) often leads to maladaptive responses. We assessed the prevalence and clinical implications of LV remodeling considering LV volume, mass, and relative wall thickness at the time of AR diagnosis. Methods and Results: Between 2008 and 2017, 370 consecutive patients (mean age 67.3 ± 16.1 years, 56.5% males), with moderate or severe AR, were retrospectively analyzed. LV geometric patterns and clinical outcomes (cardiovascular death, hospitalization for heart failure, or aortic valve replacement) were evaluated. LV dilatation (LV end-diastolic volume >75 mL/m2) was present in 228 patients (61.6%). Applying the new LV remodeling classification system, 40 (10.8%) patients had normal geometry, 14 (3.8%) concentric remodeling, 43 (11.6%) concentric hypertrophy (LVH), 45 (12.2%) indeterminate LVH, 38 (10.3%) mixed LVH, 93 (25.1%) dilated LVH, 54 (14.6%) eccentric LVH, and 43 (11.6%) eccentric remodeling. During a median follow-up of 3.48 years (25th–75th percentile 0.91–5.57), 97 (26.2%) had the combined endpoint. LV dilation (P < 0.001), LVH (P < 0.001), and LV remodeling patterns were significantly associated with the combined endpoint. After multivariable adjustment for age, EF, aortic stenosis, CAD history, and moderate mitral regurgitation, dilated LVH (HR 7.61, IC 95% 1.82–31.80; P = 0.005) and eccentric LVH (HR 7.91, IC 95% 1.82–34.38; P = 0.006) were associated with adverse outcome compared to eccentric remodeling, that showed the best event-free survival rate. Conclusions: In a contemporary cohort of patients with AR, applying the new LV remodeling classification system, only a minority had normal geometry. Dilated LVH and eccentric LVH showed distinct outcome penalty after adjustment for confounders.

2019 - Occurrence of atrial fibrillation in pacemaker patients and its association with sleep apnea and heart rate variability [Articolo su rivista]
Mazza, A.; Bendini, M. G.; Valsecchi, S.; Lovecchio, M.; Leggio, M.; De Cristofaro, R.; Boriani, G.
abstract

Aims: Sleep apnea (SA) is a risk factor for atrial fibrillation (AF) occurrence. Sympathovagal imbalance is a mechanism that predisposes to the development of AF and that occurs in SA. Some pacemakers can detect SA events and continuously measure a time domain measure of heart rate variability (HRV), i.e. the standard deviation of 5-min median atrial–atrial sensed intervals (SDANN). We evaluated the association between the occurrence of AF and device-detected SA and SDANN in patients who received pacemakers. Methods: We enrolled 150 consecutive patients undergoing implantation of a dual-chamber pacemaker, capable of SA and SDANN estimation. The SA was defined as severe if the Respiratory Disturbance Index was ≥30 episodes/h for at least one night during the first week after implantation. Results: Sixteen patients in permanent AF were excluded from our analysis. During follow-up, AF (cumulative device-detected AF duration > 6 h/day) occurred in 24(18%) patients out of the remaining 134 patients. Severe SA was detected in 84 patients. SDANN values were available in 74 patients and the median value was 76 ms [25°–75°percentile:58–77]. The risk of AF was higher in patients with severe SA (log-rank test; p = .033). The presence of either or both conditions (severe SA and SDANN < 76 ms) was associated with shorter time to AF event (p = .042) and was an independent predictor of AF (hazard ratio: 2.37; 95%CI:1.08 to 5.21; p = .033). Conclusion: In pacemaker patients, device-diagnosed severe SA and reduced SDANN are associated with a higher risk of AF.

2019 - Oral anticoagulation for subclinical atrial tachyarrhythmias detected by implantable cardiac devices: an international survey of the AF-SCREEN Group [Articolo su rivista]
Boriani, G.; Healey, J. S.; Schnabel, R. B.; Lopes, R. D.; Calkins, H.; Camm, J. A.; Freedman, B.
abstract

Aims: At present, there is little evidence on how to treat subclinical atrial fibrillation (SCAF) or atrial high rate episodes (AHREs) detected by cardiac implantable electronic devices (CIEDs). Our aim was to assess current practice around oral anticoagulation (OAC) in such patients. Methods: A web-based survey undertaken by 310 physicians: 59 AF-SCREEN International Collaboration members and 251 non-members. Results: In patients with SCAF/AHRE and a CHA2DS2VASc ≥ 2 in males or ≥ 3 in female the amount of SCAF/AHRE triggering use of OAC was variable but <2% of respondents considered that no AHRE would require OAC. Around one third (34%) considered SCAF/AHRE duration of >5–6 min as the basis for OAC prescription, while 16% and 18% required a burden of at least 5.5 h or 24 h, respectively. The propensity to prescribe OAC for a low burden of AHREs differed according to certain respondent characteristics (greater propensity to prescribe OAC for neurologists). When the clinical scenario included a prior stroke or a prior cardioembolic stroke, stated prescription of OAC was very high. More than 96% felt that any SCAF/AHRE should be treated with OAC. Conclusions: There is substantial heterogeneity in the perception of the risk of stroke/systemic embolism associated with SCAF/AHRE of variable duration. The threshold of AHRE burden that would trigger initiation of OAC is highly variable, and differs according to the clinical scenario (lower threshold in case of previous stroke). Ongoing trials will clarify the real benefit and risk/benefit ratio of OAC in this specific clinical setting.

2019 - Reactive atrial-based antitachycardia pacing therapy reduces atrial tachyarrhythmias [Articolo su rivista]
Crossley, G. H.; Padeletti, L.; Zweibel, S.; Hudnall, J. H.; Zhang, Y.; Boriani, G.
abstract

Background: Reactive atrial-based antitachycardia pacing (rATP) aims to terminate atrial tachyarrhythmia/atrial fibrillation (AT/AF) episodes when they spontaneously organize to atrial flutter or atrial tachycardia; however, its effectiveness in the real-world has not been studied. We used a large device database (Medtronic CareLink, Medtronic, Minneapolis, MN, USA) to evaluate the effects of rATP at reducing AT/AF. Methods: Pacemaker, defibrillator, and resynchronization device transmission data were analyzed. Eligible patients had device detected AT/AF during a baseline period but were not in persistent AT/AF immediately preceding first transmission. Note that 1:1 individual matching between groups was conducted using age, sex, device type, pacing mode, AT/AF, and percent ventricular pacing at baseline. Risks of AT/AF events were compared between patients with rATP-enabled versus control patients with rATP-disabled or not available in the device. For matched patients, AT/AF event rates at 2 years were estimated by Kaplan-Meier method, and hazard ratios (HRs) were calculated by Cox proportional hazard models. Results: Of 43,440 qualifying patients, 4,203 had rATP on. Matching resulted in 4,016 pairs, totaling 8,032 patients for analysis. The rATP group experienced significantly lower risks of AT/AF events lasting ≥1 day (HR 0.81), ≥7 days (HR 0.64), and ≥30 days (HR 0.56) compared to control (P < 0.0001 for all). In subgroup analysis, rATP was associated with reduced risks of AT/AF events across age, sex, device type, baseline AT/AF, and preventive atrial pacing. Conclusions: Among real-world patients from a large device database, rATP therapy was significantly associated with a reduced risk of AT/AF. This association was independent of whether the patient had a pacemaker, defibrillator, or resynchronization device.

2019 - Relationship between body mass index and outcomes in patients with atrial fibrillation treated with edoxaban or warfarin in the ENGAGE AF-TIMI 48 trial [Articolo su rivista]
Boriani, G.; Ruff, C. T.; Kuder, J. F.; Shi, M.; Lanz, H. J.; Rutman, H.; Mercuri, M. F.; Antman, E. M.; Braunwald, E.; Giugliano, R. P.
abstract

Aims To investigate the relationship between body mass index (BMI) and outcomes in patients with atrial fibrillation (AF). Methods and results In the ENGAGE AF-TIMI 48 trial, patients with AF were randomized to warfarin (international normalized ratio 2.0–3.0) or edoxaban. The cohort (N = 21 028) included patients across BMI categories (kg/m2): underweight (<18.5) in 0.8%, normal (18.5 to <25) in 21.4%, overweight (25 to <30) in 37.6%, moderately obese (30 to <35) in 24.8%, severely obese (35 to <40) in 10.0%, and very severely obese (≥40) in 5.5%. In an adjusted analysis, higher BMI (continuous, per 5 kg/m2 increase) was significantly and independently associated with lower risks of stroke/ systemic embolic event (SEE) [hazard ratio (HR) 0.88, P = 0.0001], ischaemic stroke/SEE (HR 0.87, P < 0.0001), and death (HR 0.91, P < 0.0001), but with increased risks of major (HR 1.06, P = 0.025) and major or clinically relevant non-major bleeding (HR 1.05, P = 0.0007). There was a significant interaction between sex and increasing BMI category, with lower risk of ischaemic stroke/SEE in males and increased risk of bleeding in women. Trough edoxaban concentration and anti-Factor Xa activity were similar across BMI groups >18.5 kg/m2, while time in therapeutic range for warfarin improved significantly as BMI increased (P < 0.0001). The effects of edoxaban vs. warfarin on stroke/SEE, major bleeding, and net clinical outcome were similar across BMI groups. Conclusion An increased BMI was independently associated with a lower risk of stroke/SEE, better survival, but increased risk of bleeding. The efficacy and safety profiles of edoxaban were similar across BMI categories ranging from 18.5 to >40.

2019 - Remodeling classification system considering left ventricular volume in patients with aortic valve stenosis: Association with adverse cardiovascular outcomes [Articolo su rivista]
Barbieri, A.; Bartolacelli, Y.; Bursi, F.; Manicardi, M.; Boriani, G.
abstract

Background: To assess prevalence and clinical implications of left ventricular (LV) remodeling considering: LV volume, mass and relative wall thickness at the time of aortic valve stenosis diagnosis. Methods and Results: We retrospectively analyzed 343 patients (age 79.2 ± 9.5 years, 48.1% males) with functional aortic valve area (AVA) ≤ 1.5 cm 2 . LV geometric patterns and clinical outcomes (combined death, cardiac hospitalization, aortic valve replacement [AVR]) were evaluated. According to the new LV remodeling classification, 4.9% had normal geometry, 7.5% concentric remodeling, 39.3% concentric hypertrophy (LVH), 22.4% mixed LVH, 12.5% dilated LVH, 3.2% eccentric LVH and 4.3% eccentric remodeling, 5.5% had not classifiable LVH. Indexed stroke volume (SVi) was higher in patients with concentric LVH (40.3 ± 11.9 mL/m 2 ) and mixed LVH (41.6 ± 13.4 mL/m 2 ) and lower in patients with eccentric LVH (24.9 ± 7.7 mL/m 2 ), concentric (36.6 ± 12.7 mL/m 2 ) and eccentric remodeling (34.9 ± 9.5 mL/m 2 ), P = 0.003. During a median follow-up of 2.2 years, 260 (75.8%) had the combined end point. A significant association between the combined end point and LV dilation (P = 0.010) or LV remodeling patterns (P = 0.0001) was found. After multivariable adjustment for AVR, concentric remodeling (HR 3.12, IC 95% 1.14–8.55; P = 0.02) and dilated LVH (HR 3.48, IC 95% 1.31–9.27; P = 0.01) were strongly associated with death or cardiac hospitalizations. Conclusions: In patients with AVA ≤ 1.5 cm 2 , when the new LV remodeling classification system is applied, only a minority had normal geometry and less than half had “classic” concentric LVH or remodeling. LV volume dilatation is frequent and associated with adverse outcome. Concentric remodeling, eccentric remodeling, dilated LVH had the worst noninvasive hemodynamic profile and prognosis.

2019 - Safety and efficacy of dronedarone from clinical trials to real-world evidence: Implications for its use in atrial fibrillation [Articolo su rivista]
Boriani, G.; Blomstrom-Lundqvist, C.; Hohnloser, S. H.; Bergfeldt, L.; Botto, G. L.; Capucci, A.; Lozano, I. F.; Goette, A.; Israel, C. W.; Merino, J. L.; Camm, A. J.
abstract

Efficacy and safety of dronedarone was shown in the ATHENA trial for paroxysmal or persistent atrial fibrillation (AF) patients. Further trials revealed safety concerns in patients with heart failure and permanent AF. This review summarizes insights from recent real-world studies and meta-analyses, including reports on efficacy, with focus on liver safety, mortality risk in patients with paroxysmal/persistent AF, and interactions of dronedarone with direct oral anticoagulants. Reports of rapidly progressing liver failure in dronedarone-prescribed patients in 2011 led to regulatory cautions about potential liver toxicity. Recent real-world evidence suggests dronedarone liver safety profile is similar to other antiarrhythmics and liver toxicity could be equally common with many Class III antiarrhythmics. Dronedarone safety concerns (increased mortality in patients with permanent AF) were raised based on randomized controlled trials (RCT) (ANDROMEDA and PALLAS), but comedication with digoxin may have increased the mortality rates in PALLAS, considering the dronedarone-digoxin pharmacokinetic (PK) interaction. Real-world data on apixaban-dronedarone interactions and edoxaban RCT observations suggest no significant safety risks for these drug combinations. Median trough plasma concentrations of dabigatran 110 mg during concomitant use with dronedarone are at acceptable levels, while PK data on the rivaroxaban-dronedarone interaction are unavailable. In RCTs and real-world studies, dronedarone significantly reduces AF burden and cardiovascular hospitalizations, and demonstrates a low risk for proarrhythmia in patients with paroxysmal or persistent AF. The concerns on liver safety must be balanced against the significant reduction in hospitalizations in patients with non-permanent AF and low risk for proarrhythmias following dronedarone treatment.

2019 - Screening for atrial fibrillation: Need for an integrated, structured approach [Articolo su rivista]
Boriani, G.; Proietti, M.
abstract

2019 - Searching for Atrial Fibrillation Poststroke: A White Paper of the AF-SCREEN International Collaboration [Articolo su rivista]
Schnabel, R. B.; Haeusler, K. G.; Healey, J. S.; Freedman, B.; Boriani, G.; Brachmann, J.; Brandes, A.; Bustamante, A.; Casadei, B.; Crijns, H. J. G. M.; Doehner, W.; Engstrom, G.; Fauchier, L.; Friberg, L.; Gladstone, D. J.; Glotzer, T. V.; Goto, S.; Hankey, G. J.; Harbison, J. A.; Hobbs, F. D. R.; Johnson, L. S. B.; Kamel, H.; Kirchhof, P.; Korompoki, E.; Krieger, D. W.; Lip, G. Y. H.; Lochen, M. -L.; Mairesse, G. H.; Montaner, J.; Neubeck, L.; Ntaios, G.; Piccini, J. P.; Potpara, T. S.; Quinn, T. J.; Reiffel, J. A.; Ribeiro, A. L. P.; Rienstra, M.; Rosenqvist, M.; Sakis, T.; Sinner, M. F.; Svendsen, J. H.; Van Gelder, I. C.; Wachter, R.; Wijeratne, T.; Yan, B.
abstract

Cardiac thromboembolism attributed to atrial fibrillation (AF) is responsible for up to one-third of ischemic strokes. Stroke may be the first manifestation of previously undetected AF. Given the efficacy of oral anticoagulants in preventing AF-related ischemic strokes, strategies of searching for AF after a stroke using ECG monitoring followed by oral anticoagulation (OAC) treatment have been proposed to prevent recurrent cardioembolic strokes. This white paper by experts from the AF-SCREEN International Collaboration summarizes existing evidence and knowledge gaps on searching for AF after a stroke by using ECG monitoring. New AF can be detected by routine plus intensive ECG monitoring in approximately one-quarter of patients with ischemic stroke. It may be causal, a bystander, or neurogenically induced by the stroke. AF after a stroke is a risk factor for thromboembolism and a strong marker for atrial myopathy. After acute ischemic stroke, patients should undergo 72 hours of electrocardiographic monitoring to detect AF. The diagnosis requires an ECG of sufficient quality for confirmation by a health professional with ECG rhythm expertise. AF detection rate is a function of monitoring duration and quality of analysis, AF episode definition, interval from stroke to monitoring commencement, and patient characteristics including old age, certain ECG alterations, and stroke type. Markers of atrial myopathy (eg, imaging, atrial ectopy, natriuretic peptides) may increase AF yield from monitoring and could be used to guide patient selection for more intensive/prolonged poststroke ECG monitoring. Atrial myopathy without detected AF is not currently sufficient to initiate OAC. The concept of embolic stroke of unknown source is not proven to identify patients who have had a stroke benefitting from empiric OAC treatment. However, some embolic stroke of unknown source subgroups (eg, advanced age, atrial enlargement) might benefit more from non-vitamin K-dependent OAC therapy than aspirin. Fulfilling embolic stroke of unknown source criteria is an indication neither for empiric non-vitamin K-dependent OAC treatment nor for withholding prolonged ECG monitoring for AF. Clinically diagnosed AF after a stroke or a transient ischemic attack is associated with significantly increased risk of recurrent stroke or systemic embolism, in particular, with additional stroke risk factors, and requires OAC rather than antiplatelet therapy. The minimum subclinical AF duration required on ECG monitoring poststroke/transient ischemic attack to recommend OAC therapy is debated.

2019 - Stroke Prevention, Evaluation of Bleeding Risk, and Anticoagulant Treatment Management in Atrial Fibrillation Contemporary International Guidelines [Articolo su rivista]
Proietti, M.; Lane, D. A.; Boriani, G.; Lip, G. Y. H.
abstract

In recent years the management of atrial fibrillation patients has progressively and substantially changed because of the introduction of new treatments and the availability of new data regarding the epidemiology and clinical management of these patients. In the past 2 years alone, there have been 7 new guidelines or guideline updates that have been published, which have introduced new recommendations and significantly revised previously published ones. Two updates for Canadian guidelines were published in 2016 and 2018, whereas guidelines from the European Society of Cardiology in 2016, Asia Pacific Heart Rhythm Society were published in 2017, National Heart Foundation of Australia/Cardiac Society of Australia and New Zealand, American College of Chest Physicians, and Korean Heart Rhythm Society have been published in 2018. In this narrative review we provide a comparison of these contemporary international guidelines, with particular attention on the evaluation of thromboembolic and bleeding risks and management of oral anticoagulant therapy. From the analysis of contemporary guidelines on the management of atrial fibrillation, a general agreement is evident about the baseline evaluation of thromboembolic and bleeding risk, as well as a preference for the use of non-vitamin K antagonist oral anticoagulants. Also, regarding the concomitant use of oral anticoagulant and antiplatelet drugs in patients with acute coronary syndromes, undergoing elective percutaneous coronary intervention, catheter ablation, and cardioversion procedures, all of the guidelines agree on the general principles and are supported by evidence. More data are still needed to better substantiate recommendations for specific atrial fibrillation subpopulations. The need for an integrated approach and holistic management is highlighted in the more recently published guidelines.

2019 - The 12-lead ECG: A continuous reference for the cardiologist [Articolo su rivista]
Boriani, G.; Vitolo, M.
abstract

2019 - The Pacemaker and Implantable Cardioverter-Defibrillator Registry of the Italian Association of Arrhythmology and Cardiac Pacing - Annual Report 2017 [Articolo su rivista]
Proclemer, A; Zecchin, M; D'Onofrio, A; Ricci, Rp; Boriani, G; Facchin, D; Rebellato, L; Ghidina, M; Bianco, G; Bernardelli, E; Miconi, A; Zorzin, Af; Gregori, D
abstract

Background. The pacemaker (PM) and implantable cardioverter-defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) monitors the main epidemiological data in real-world practice. The survey for the 2017 activity collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers.Methods. The Registry collects prospectively national PM and ICD implantation activity on the basis of European cards.Results. PM Registry: data about 23 457 PM implantations were collected (19 378 first implant and 4079 replacements). The number of collaborating centers was 185. Median age of treated patients was 81 years (75 quartile I; 86 quartile III). ECG indications included atrioventricular conduction disorders in 37.1% of first PM implants, sick sinus syndrome in 19.5%, atrial fibrillation plus bradycardia in 13.2%, other in 30.2%. Among atrioventricular conduction defects, third-degree atrioventricular block was the most common type (21.0% of first implants). Use of single-chamber PMs was reported in 25.6% of first implants, of dual-chamber PMs in 66.7%, of PMs with cardiac resynchronization therapy (CRT) in 1.4%, and of single lead atrial-synchronized ventricular stimulation (VDD/R PMs) in 6.3%. ICD Registry: data about 19 023 ICD implantations were collected (13 898 first implants and 5125 replacements). The number of collaborating centers was 437. Median age of treated patients was 71 years (63 quartile I; 78 quartile III). Primary prevention indication was reported in 81.8% of first implants, secondary prevention in 18.2% (cardiac arrest in 6.4%). A single-chamber ICD was used in 27.0% of first implants, dual-chamber in 33.6% and biventricular in 39.3%.Conclusions. The PM and ICD Registry appears fundamental for monitoring PM and ICD utilization on a large national scale with rigorous examination of demographics and clinical indications. The PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The use of CRT-PM regards a very limited number of patients. The ICD Registry documented a large use of prophylactic and biventricular ICD, reflecting a favorable adherence to trials and guidelines in clinical practice. In order to increase and optimize the cooperation of Italian implanting centers, online data entry (http://www.aiac.it/riprid) should be adopted at large scale.

2019 - The future of continuing medical education: the roles of medical professional societies and the health care industry: Position paper prepared with contributions from the European Society of Cardiology Committees for Advocacy, Education and Industry Relations, Endorsed by the Board of the European Society of Cardiology [Articolo su rivista]
Bax, Jeroen; Casadei, Barbara; Graham, Ian; Pinto, Fausto; Anker, Stefan; Badimon, Lina; Merkaly, Bela; Bueno, Hector; Clarke, Sarah; Fitzsimons, Donna; Leclerq, Christophe; Linde, Cecilia; Weidinger, Franz; Lettino, Maddalena; Popescu, Bogdan; Grobbee, Diederick; Haude, Michael; Hindricks, Gerhard; Ruschitzka, Frank; Achenbach, Stephan; Clarke, Nigel; Cosentino, Francesco; Filippatos, Gerasimos; Kearney, Peter; Kirchhof, Paulus; Kristensen, Steen Dalby; Luscher, Thomas; Olsson, Gunnar; Vahanian, Alec; Windecker, Stephan; Zamorano, Jose; Simoons, Maarten; Kearney, Peter; de Boer, Rudolf; Bueno, Hector; Byrne, Robert; Caiani, Enrico Gianluca; Cowie, Martin; Fraser, Alan; James, Stefan; Kautzner, Josef; Maniadakis, Nikos; Perk, Joep; Pries, Axel Radlach; Ryden, Lars; Vardas, Panos; Van de Werf, Frans; Kirchhof, Paulus; Baldus, Stephan; van der Bilt, Ivo; Burri, Harran; Fox, Kevin; Gonçalves, Lino; Grapsa, Julia; von Haehing, Stephan; Juantaney, Jose Ramon; Kearney, Peter; Kjaergaard, Jesper; Kletsiou, Eleni; Kontsevaya, Anna; Kotecha, Dipak; Landmesser, Ulf; Milicic, Davor; Mulder, Barbara; Pasquet, Agnes; Price, Susanna; Ribeiras, Regina; Sadaba, Rafael; Sirnes, Per Anton; Sionis, Alessandro; Tanner, Felix; Varenne, Olivier; Verhost, Patrick; Simoons, Maarten; Boriani, Giuseppe; Byrne, Robert; Cosentino, Francesco; Dickstein, Kenneth; Fox, Kim; Haude, Michael; Pilgrim, Thomas; Ryden, Lars; Van de Werf, Frans; Delmas, Aoife
abstract

In recent years, wide ranging biomedical innovation has provided powerful new approaches for prevention, diagnosis and management of diseases. In order to translate such innovation into effective practice, physicians must frequently update their knowledge base and skills through continuing medical education and training. Medical Professional Societies, run as not-for-profit organizations led by peers, are uniquely placed to deliver balanced, disease oriented and patient centred education. The medical industry has a major role in the development of new, improved technology, devices and medication. In fact, the best innovations have been achieved through collaboration with scientists, clinical academics and practicing physicians. Industry has for many years been committed to ensure the optimal and safe application of its products by providing unrestricted support of medical education developed and delivered by international and national learned societies. Recently adopted Codes of Practice for the Pharmaceutical and Device industry were intended to enhance public trust in the relationship between biomedical industry and physicians. Unexpectedly, changes resulting from adoption of the Codes have limited the opportunity for unconditional industry support of balanced medical education in favour of a more direct involvement of industry in informing physicians about their products. We describe the need for continuing medical education in Cardiovascular Medicine in Europe, interaction between the medical profession and medical industry, and propose measures to safeguard the provision of high quality, balanced medical education.

2019 - The role of physical activity in individuals with cardiovascular risk factors: an opinion paper from Italian Society of Cardiology-Emilia Romagna-Marche and SIC-Sport [Articolo su rivista]
Nasi, Milena; Patrizi, Giampiero; Pizzi, Carmine; Landolfo, Matteo; Boriani, Giuseppe; Dei Cas, Alessandra; Cicero, Arrigo F G; Fogacci, Federica; Rapezzi, Claudio; Sisca, Giovanbattista; Capucci, Alessandro; Vitolo, Marco; Galiè, Nazzareno; Borghi, Claudio; Berrettini, Umberto; Piepoli, Massimo; Mattioli, Anna V
abstract

: Regular physical activity is a cornerstone in the prevention and treatment of atherosclerotic cardiovascular disease (CVD) due to its positive effects in reducing several cardiovascular risk factors. Current guidelines on CVD suggest for healthy adults to perform at least 150 min/week of moderate intensity or 75 min/week of vigorous intensity aerobic physical activity. The current review explores the effects of physical activity on some risk factors, specifically: diabetes, dyslipidemia, hypertension and hyperuricemia. Physical activity induces an improvement in insulin sensitivity and in glucose control independently of weight loss, which may further contribute to ameliorate both diabetes-associated defects. The benefits of adherence to physical activity have recently proven to extend beyond surrogate markers of metabolic syndrome and diabetes by reducing hard endpoints such as mortality. In recent years, obesity has greatly increased in all countries. Weight losses in these patients have been associated with improvements in many cardiometabolic risk factors. Strategies against obesity included caloric restriction, however greater results have been obtained with association of diet and physical activity. Similarly, the beneficial effect of training on blood pressure via its action on sympathetic activity and on other factors such as improvement of endothelial function and reduction of oxidative stress can have played a role in preventing hypertension development in active subjects. The main international guidelines on prevention of CVD suggest to encourage and to increase physical activity to improve lipid pattern, hypertension and others cardiovascular risk factor. An active action is required to the National Society of Cardiology together with the Italian Society of Sports Cardiology to improve the prescription of organized physical activity in patients with CVD and/or cardiovascular risk factors.

2019 - Usefulness of Red Cells Distribution Width to Predict Worse Outcomes in Patients With Atrial Fibrillation [Articolo su rivista]
Malavasi, V. L.; Proietti, M.; Spagni, S.; Valenti, A. C.; Battista, A.; Pettorelli, D.; Colella, J.; Vitolo, M.; Lip, G. Y.; Boriani, G.
abstract

Red cells distribution width (RDW) is a measure of red cell size variability, but little is known about the relation between RDW and outcomes in atrial fibrillation (AF).The aims of our study were to evaluate the association between RDW values, AF patients’ profile and outcomes. Consecutive patients with ECG-confirmed AF were divided in 3 groups according to tertiles of RDW values (≤13.5%, 13.6% to 14.6%, >14.6%).We enrolled 457 patients, 61.9% males, median (interquartile range) age 74 (66 to 80). Both CHA2DS2-VASc and HAS-BLED scores increased progressively according to RDW tertiles. During follow-up, there was an increased risk for all-cause death and the composite end point in the highest RDW tertile (p <0.001 for both outcomes). On multivariate Cox regression analysis, the highest RDW tertile was independently associated with all-cause death (hazard ratio [HR] 3.23, 95% confidence interval [CI] 1.04 to 10.00) and the composite end point (HR 2.04, 95% CI 1.12 to 3.70). RDW as a continuous variable was also independently associated with all cause death and the composite outcome (HR 1.16, 95% CI 1.02 to 1.31 and HR 1.16, 95% CI 1.05 to 1.27, respectively). In conclusion, in a real-life AF population, RDW is associated with clinical factors indicating a worse profile and is independently associated with increased risks of all-cause death and other clinical events.

2018 - 12-year Temporal Trend in Referral Pattern and Test Results of Stress Echocardiography in a Tertiary Care Referral Center with Moderate Volume Activities and Cath-lab Facility [Articolo su rivista]
Barbieri, Andrea; Mantovani, Francesca; Bursi, Francesca; Bartolacelli, Ylenia; Manicardi, Marcella; Lauria, Maria Giulia; Boriani, Giuseppe
abstract

Background: Data on stress echocardiography (SE) time-related changes in referral patterns and diagnostic yield for detection of inducible ischemia could enhance Echo Lab quality benchmarks and performance measures. Aim: This study aims to evaluate temporal trends in SE test results among ambulatory patients with suspected or known coronary artery disease (CAD) in a tertiary care referral center with moderate (>100/year) volume SE activities and Cath-Lab facility. Methods: From January 2004 to December 2015, 1954 patients (mean age 62 ± 12 years, 42% women, 27% with known CAD) underwent SE (1673 exercise SE, 86%, 246 pharmacological SE, 12%, 35 pacing SE, 2%). Time was grouped into three 4 year periods, where clinical data and test results were evaluated. Results: Our series comprised low-to-intermediate pretest probability of CAD throughout the observation period (overall pretest probability of CAD 19% ± 15%). A progressive decline over time in the rate of pharmacological SE instead of a dramatic increment of exercise SE (79%-96%, P < 0.0001) was noted. The use of beta-blockers increased (from 43% to 66%, P < 0.0001), while the use of nitrates decreased (from 11% to 4%, P < 0.0001) over time. We noted a very uncommon occurrence of abnormal test results with a further decrease in the last period (from 11% to 3%, P < 0.0001). Conclusions: We observed, over a 12-year period, a progressive decrease in the frequency of inducible myocardial ischemia among patients with known or suspected CADe referred to our Echo Lab for SE with Cath-Lab facility, and this trend was parallel to changes in SE referral practice. These findings are particularly relevant if we consider the practical implications on diagnostic SE accuracy and risk assessment.

2018 - 2018 EHRA expert consensus statement on lead extraction: Recommendations on definitions, endpoints, research trial design, and data collection requirements for clinical scientific studies and registries: Endorsed by APHRS/HRS/LAHRS [Articolo su rivista]
Bongiorni, Maria G; Burri, Haran; Deharo, Jean C; Starck, Christoph; Kennergren, Charles; Saghy, Laszlo; Rao, Archana; Tascini, Carlo; Lever, Nigel; Kutarski, Andrzej; Fernandez Lozano, Ignacio; Strathmore, Neil; Costa, Roberto; Epstein, Laurence; Love, Charles; Blomstrom-Lundqvist, Carina; Fauchier, Laurent; Defaye, Pascal; Arnar, David O; Klug, Didier; Boveda, Serge; Nielsen, Jens Cosedis; Boriani, Giuseppe; Zhang, Shu; Martin, Andrew Paul; Prutkin, Jordan M; De Zuloaga, Claudio
abstract

NA

2018 - A closer look into the complexity of our practice: Outcome research for transvenous temporary cardiac pacing [Articolo su rivista]
Boriani, Giuseppe; Diemberger, Igor
abstract

NA

2018 - Acute hemodynamic effects of intravenous adenosine in patients with associated pulmonary arterial hypertension: Comparison with intravenous epoprostenol [Articolo su rivista]
Rossi, Rosario; Coppi, Francesca; Sgura, Fabio; Monopoli, Daniel Enrique; Boriani, Giuseppe
abstract

Exogenous intravenous (IV) adenosine and epoprostenol are effective vasodilator agents, causing a substantial reduction in pulmonary vascular resistance in patients affected by idiopathic pulmonary arteriolar hypertension (PAH). Their action, in patients with PAH associated with other pathological conditions, is not well defined. In the present paper the authors retrospectively analyzed the acute hemodynamic effects of intravenous adenosine and epoprostenol in 30 consecutive patients (mean age: 58 ± 15 years; 21 females, and 9 males) affected by PAH associated with other pathological conditions, as determined by changes from baseline in systemic and pulmonary hemodynamic parameters. Acute IV administration of adenosine decreased pulmonary vascular resistance index (PVRI) by 3 Wood U/m(2) (- 20%) compared to baseline (p = 0.02). We noted a slight, not significant, decrease in mean pulmonary artery pressure (mPAP) of 4 mmHg. Cardiac index (CI) increased by 0.5 L/min/m(2) (15% increase respect to baseline; p = 0.03). The heart rate and mean systemic blood pressure (BP) did not change significantly. Acute IV administration of epoprostenol decreased PVRI by 6 mmHg (- 40%) respect to baseline (p < 0.0001). CI increased by 1.4 L/min/m(2) (p < 0.0001); while mPAP decreased by 5 mmHg (nearly 10%) (p = 0.04). This decrease of mPAP was accompanied by a mean BP decrease of 11 mmHg compared to baseline (p = 0.003). Our results indicates that, in patients with PAH associated with other pathological conditions, adenosine is predominantly a positive inotropic agent; and epoprostenol a potent vasodilator of both pulmonary and systemic vessels, and a strong positive inotropic agent.

2018 - Antiarrhythmic drugs-clinical use and clinical decision making: A consensus document from the European Heart Rhythm Association (EHRA) and European Society of Cardiology (ESC) Working Group on Cardiovascular Pharmacology, endorsed by the Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS) and International Society of Cardiovascular Pharmacotherapy (ISCP) [Articolo su rivista]
Dan, Gheorghe-Andrei; Martinez-Rubio, Antoni; Agewall, Stefan; Boriani, Giuseppe; Borggrefe, Martin; Gaita, Fiorenzo; Van Gelder, Isabelle; Gorenek, Bulent; Kaski, Juan Carlos; Kjeldsen, Keld; Lip, Gregory Y. H.; Merkely, Bela; Okumura, Ken; Piccini, Jonathan P.; Potpara, Tatjana; Poulsen, Birgitte Klindt; Saba, Magdi; Savelieva, Irina; Tamargo, Juan L.; Wolpert, Christian; Sticherling, Christian; Ehrlich, Joachim R.; Schilling, Richard; Pavlovic, Nikola; De Potter, Tom; Lubinski, Andrzej; Svendsen, Jesper Hastrup; Ching, Keong; Sapp, John Lewis; Chen-Scarabelli, Carol; Martinez, Felipe
abstract

NA

2018 - Antithrombotic Therapy for Atrial Fibrillation: CHEST Guideline and Expert Panel Report [Articolo su rivista]
Lip, Gregory Y H; Banerjee, Amitava; Boriani, Giuseppe; Chiang, Chern En; Fargo, Ramiz; Freedman, Ben; Lane, Deirdre A.; Ruff, Christian T.; Turakhia, Mintu; Werring, David; Patel, Sheena; Moores, Lisa
abstract

BACKGROUND: The risk of stroke is heterogeneous across different groups of patients with atrial fibrillation (AF), being dependent on the presence of various stroke risk factors. We provide recommendations for antithrombotic treatment based on net clinical benefit for patients with AF at varying levels of stroke risk and in a number of common clinical scenarios. METHODS: Systematic literature reviews were conducted to identify relevant articles published from the last formal search perfomed for the Antithrombotic and Thrombolytic Therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (9th Edition). The overall quality of the evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach. Graded recommendations and ungraded consensus-based statements were drafted, voted on, and revised until consensus was reached. RESULTS: For patients with AF without valvular heart disease, including those with paroxysmal AF, who are at low risk of stroke (eg, CHA2DS2-VASc [congestive heart failure, hypertension, age&nbsp;≥ 75 (doubled), diabetes, stroke (doubled)-vascular disease, age 65-74 and sex category (female)] score of 0 in males or 1 in females), we suggest no antithrombotic therapy. The next step is to consider stroke prevention (ie, oral anticoagulation therapy) for patients with 1 or more non-sex CHA2DS2-VASc stroke risk factors. For patients with a single non-sex CHA2DS2-VASc stroke risk factor, we suggest oral anticoagulation rather than no therapy, aspirin, or combination therapy with aspirin and clopidogrel; and for those at high risk of stroke (eg, CHA2DS2-VASc&nbsp;≥ 2 in males or&nbsp;≥ 3 in females), we recommend oral anticoagulation rather than no therapy, aspirin, or combination therapy with aspirin and clopidogrel. Where we recommend or suggest in favor of oral anticoagulation, we suggest using a non-vitamin K antagonist oral anticoagulant drug rather than adjusted-dose vitamin K antagonist therapy. With the latter, it is important to aim for good quality anticoagulation control with a time in therapeutic range &gt; 70%. Attention to modifiable bleeding risk factors (eg, uncontrolled BP, labile international normalized ratios, concomitant use of aspirin or nonsteroidal antiinflammatory drugs in an anticoagulated patient, alcohol excess) should be made at each patient contact, and HAS-BLED (hypertension, abnormal renal/liver function [1 point each], stroke, bleeding history or predisposition, labile international normalized ratio, elderly (0.65), drugs/alcohol concomitantly [1 point each]) score used to assess the risk of bleeding where high risk patients (≥ 3) should be reviewed and followed up more frequently. CONCLUSIONS: Oral anticoagulation is the optimal choice of antithrombotic therapy for patients with AF with&nbsp;≥1 non-sex CHA2DS2-VASc stroke risk factor(s).

2018 - Arterial hypertension in patients with atrial fibrillation in Europe: A report from the EURObservational Research Programme pilot survey on atrial fibrillation [Articolo su rivista]
Dan, G. A.; Badila, E.; Weiss, E.; Laroche, C.; Boriani, G.; Dan, A.; Tavazzi, L.; Maggioni, A. P.; Crijns, H. J.; Popescu, R.; Blommaert, D.; Streb, W.; Lip, G. Y. H.
abstract

Background: Hypertension (HTN) is the most prevalent co-morbidity among atrial fibrillation (AF) patients; the relationship between the two is bidirectional, with an incremental effect on adverse outcomes. Purpose: To study clinical features, treatment patterns and 1 year outcomes amongst AF patients with HTN in the EURObservational Research Programme Atrial Fibrillation (EORP-AF) Pilot Registry, a prospective multi-national survey conducted by the European Society of Cardiology in 9 European countries. Methods: Of 3119 enrolled AF patients, 2194 were diagnosed with HTN (AF-HTN) and 909 were normotensive (AF-NT) (16 patients had unknown HTN status). We compared baseline clinical features, management strategy and 1-year outcomes in terms of all-cause death, cardiovascular (CV) death, and any thrombosis-related event (TE: stroke, transient ischemic attack, acute coronary syndrome, coronary intervention, cardiac arrest, peripheral/pulmonary embolism) in AF-HTN vs AF-NT patients. Results: The AF-HTN patients had more prevalent CV risk factors and comorbidities (median CHA2DS2-VASc score (IQR) 4 (3, 5) in AF-HTN, versus 2 (1, 3) in AF-NT; p &lt; 0.01). Crude rate of all-cause death and any TE event was higher in AF-HTN (194 (11.2%) versus 60 (8.2%), p = 0.02). Kaplan-Meier analysis curves for death by hypertensive status showed no significant differences between the subgroups (log rank test, p = 0.22). On logistic regression analysis, HTN did not emerge as an independent risk factor for outcomes (OR 1.08, 95% CI 0.76–1.54). Conclusion: AF-HTN patients have a higher prevalence of comorbidities and this conferred a higher risk for a composite endpoint of all-cause death and thromboembolic events. In this cohort HTN did not independently predict all-cause mortality at 1-year.

2018 - Atrial fibrillation and prediction of mortality by conventional clinical score systems according to the setting of care [Articolo su rivista]
Diemberger, Igor; Fantecchi, Elisa; Reggiani, Maria Letizia Bacchi; Martignani, Cristian; Angeletti, Andrea; Massaro, Giulia; Ziacchi, Matteo; Biffi, Mauro; Lip, Gregory Y. H.; Boriani, Giuseppe
abstract

Background: Atrial fibrillation (AF) is associated with high morbidity and mortality, also among anticoagulated patients. Our aim was to evaluate the predictive role for long-term mortality of a series of risk stratification scores associated with cardiovascular or thromboembolic outcomes (CHADS2, CHA2DS2-VASc, ATRIA, TIMI-AF), and bleeding complications (HAS-BLED) in an unselected population of patients with AF. Methods: Single center, observational, prospective registry of consecutive patients with AF, undergoing clinical/echocardiographic evaluation in a University Hospital, as either in-patients or out-patients. We assessed the role of each single score as predictors of long-term survival according to clinical setting. Results: We enrolled 1051 patients, mean age 72 ± 12 years, who were followed for 797 ± 298 days. All the tested scores showed a good performance in prediction of mortality, together with several clinical factors (older age, chronic heart failure, diabetes, renal impairment, previous transient ischemic attack, left ventricular ejection fraction). The values at C-statistics ranged between modest (0.608–0.684) of inpatients to good (0.708–0.751) in outpatients without any statistical difference between the scores, excepted a lower performance of HAD-BLED. Conclusions: Risk scores currently adopted for decision making on starting oral anticoagulation provide good prediction of long-term survival in unselected AF patients, especially in the outpatient setting.

2018 - Atrial fibrillation prevention: An appraisal of current evidence [Articolo su rivista]
Boriani, Giuseppe; Proietti, Marco
abstract

Atrial fibrillation (AF), which is the most diagnosed arrhythmia, is becoming a significant issue for health policy-makers. In particular, more and more attention is being devoted to AF prevention. Indeed, several studies recently published point out how targeted interventions could be useful in reducing the risk of AF occurrence (or recurrence). In this review, we briefly summarised the role of the major risk factors associated with the incidence of AF, as well as the effectiveness of interventions aimed at controlling these risk factors. Several general risk factors, such as alcohol consumption, physical activity, smoking habit, as well as specific cardiovascular risk factors as diabetes mellitus, hypertension and obesity have a relevant impact in determining the occurrence of AF, along with a strong clinical evidence of a dose-effect response mechanism for most of the factors examined. Specific interventions aimed at controlling risk factors have been showed to clearly reduce the risk of AF in several cohorts. Even more importantly, integrated programmes aimed at controlling for multiple risk factors would be more efficient in terms of reducing risk of AF, in particular whena stricter control is observed. AF prevention requires a series of initiatives focused on the many risk factors that we reviewed, as well as a more integrated approach, which should involve many stakeholders at different levels. In this light and also considering the constantly changing epidemiology, AF prevention may constitute a future 'win-win' strategy for all the stakeholders.

2018 - Atrioventricular junction ablation in patients with atrial fibrillation treated with cardiac resynchronization therapy: positive impact on ventricular arrhythmias, implantable cardioverter-defibrillator therapies and hospitalizations [Articolo su rivista]
Gasparini, Maurizio; Kloppe, Axel; Lunati, Maurizio; Anselme, Frédéric; Landolina, Maurizio; Martinez-Ferrer, Jose Bautista; Proclemer, Alessandro; Morani, Giovanni; Biffi, Mauro; Ricci, Renato; Rordorf, Roberto; Mangoni, Lorenza; Manotta, Laura; Grammatico, Andrea; Leyva, Francisco; Boriani, Giuseppe
abstract

Aims: We sought to determine whether atrioventricular junction ablation (AVJA) in patients with cardiac resynchronization therapy (CRT) implantable cardioverter-defibrillator (ICD) and with permanent atrial fibrillation (AF) has a positive impact on ICD shocks and hospitalizations compared with rate-slowing drugs. Methods and results: This is a pooled analysis of data from 179 international centres participating in two randomized trials and one prospective observational research. The co-primary endpoints were all-cause ICD shocks and all-cause hospitalizations. Out of 3358 CRT-ICD patients (2720 male, 66.6 years), 2694 (80%) were in sinus rhythm (SR) and 664 (20%) had permanent AF—262 (8%) treated with AVJA (AF + AVJA) and 402 (12%) treated with rate-slowing drugs (AF + Drugs). Median follow-up was 18 months. The mean (95% confidence intervals) annual rate of all-cause ICD shocks per 100 patient years was 8.0 (5.3–11.9) in AF + AVJA, 43.6 (37.7–50.4) in AF + Drugs, and 34.4 (32.5–36.5) in SR patients, resulting in incidence rate ratio (IRR) reductions of 0.18 (0.10–0.32) for AF + AVJA vs. AF + Drugs (P &lt; 0.001) and 0.48 (0.35–0.66) for AF + AVJA vs. SR (P &lt; 0.001). These reductions were driven by significant reductions in both appropriate ICD shocks [IRR 0.23 (0.13–0.40), P &lt; 0.001, vs. AF + Drugs] and inappropriate ICD shocks [IRR 0.09 (0.04–0.21), P &lt; 0.001, vs. AF + Drugs]. Annual rate of all-cause hospitalizations was significantly lower in AF + AVJA vs. AF + Drugs [IRR 0.57 (0.41–0.79), P &lt; 0.001] and SR [IRR 0.85 (073–0.98), P = 0.027]. Conclusion: In AF patients treated with CRT, AVJA results in a lower incidence and burden of all-cause, appropriate and inappropriate ICD shocks, as well as to fewer all-cause and heart failure hospitalizations. Clinical Trial Registration: NCT00147290, NCT00617175, NCT01007474.

2018 - Battery longevity of implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators: technical, clinical and economic aspects. An expert review paper from EHRA [Articolo su rivista]
Boriani, Giuseppe; Merino, Josè; Wright, David J; Gadler, Fredrik; Schaer, Beat; Landolina, Maurizio
abstract

In recent years an extension of devices longevity has been obtained for implantable cardioverter-defibrillators (ICDs), including ICDs for cardiac resynchronization therapy (CRT-D) through improved battery chemistry and device technology and this implies important clinical benefits (reduced need for device replacements and associated complications, particularly infections), as well as economic benefits, in line with patient preferences and needs. From a clinical point of view, the availability of this improvement in technology allows to better tune the choice of the device to be implanted, taking into account that the reasons supporting the value of an extended device longevity as a clinical priority may differ according to the clinical setting (purely electrical diseases or left ventricular dysfunction/heart failure, respectively). From an economic point of view, extension of device longevity may have an important impact in reducing long-term costs of device therapy, with substantial daily savings in favour of devices with extended longevity, up to 30%, depending on clinical scenarios. In studies based on projections, an extension of device longevity allowed to calculate that the cost per day of ICDs may be substantially reduced, and this allows to overcome the frequent perception of ICD and CRT-D devices as treatments with unaffordable costs and to overturn the misconception that up-front costs are the only metric with which to value device treatments. In view of its clinical and economic value, device longevity should be a determining factor in device choice by physicians and healthcare commissioners and should be appropriately considered and valued in comparative tenders.

2018 - Cardiac involvement in systemic sclerosis: identification of high-risk patient profiles in different patterns of clinical presentation [Articolo su rivista]
Coppi, Francesca; Giuggioli, Dilia; Spinella, Amelia; Colaci, Michele; Lumetti, Federica; Farinetti, Alberto; Migaldi, Mario; Rossi, Rosario; Ferri, Clodoveo; Boriani, Giuseppe; Mattioli, Anna Vittoria
abstract

Systemic sclerosis (SSc) is a chronic connective tissue disease characterized by widespread microvascular damage, dysregulation of fibroblasts with collagen overproduction and excessive fibrosis of the skin and internal organs, as well as complex immune system abnormalitie….

2018 - Cardiac resynchronization therapy and electrical storm: results of the OBSERVational registry on long-term outcome of ICD patients (OBSERVO-ICD) [Articolo su rivista]
Guerra, Federico; Palmisano, Pietro; Dell'Era, Gabriele; Ziacchi, Matteo; Ammendola, Ernesto; Pongetti, Giulia; Bonelli, Paolo; Patani, Francesca; Devecchi, Chiara; Accogli, Michele; Occhetta, Eraldo; Nigro, Gerardo; Biffi, Mauro; Boriani, Giuseppe; Capucci, Alessandro
abstract

Electrical storm (ES) is a condition defined as three or more episodes of ventricular fibrillation (VF) or ventricular tachycardia (VT) within 24 h, and usually coexist with advanced heart failure in patients with structural heart disease. The aim of the present study is to test whether cardiac resynchronization therapy (CRT) can be associated with a lower incidence of ES.

2018 - Cardiac resynchronization therapy in the real world: need to upgrade outcome research [Articolo su rivista]
Boriani, Giuseppe; Diemberger, Igor
abstract

NA

2018 - Cardiac resynchronization therapy: How did consensus guidelines from Europe and the United States evolve in the last 15 years? [Articolo su rivista]
Boriani, Giuseppe; Ziacchi, Matteo; Nesti, Martina; Battista, Antonella; Placentino, Filippo; Malavasi, Vincenzo Livio; Diemberger, Igor; Padeletti, Luigi
abstract

Cardiac resynchronization therapy (CRT) was proposed around 20 years ago, and its clinical use rapidly moved from pioneering experiences to randomized controlled trials (RCT). Since 2002 recommendations for CRT have been included in international consensus guidelines that even in an early phase recommended CRT as an effective treatment for improving symptoms, reducing hospitalizations and mortality in well-selected patients with wide QRS, left ventricular dysfunction and moderate to severe heart failure (NYHA classes III–IV), on optimal medical therapy. Subsequently the indications were extended to mild (NYHA class II) heart failure (associated with left ventricular dysfunction and wide QRS) and more recently also to appropriately selected patients with conventional indications for pacing having a left ventricular ejection fraction of 50% or less and NYHA class I–III. While all the guidelines strongly recommend CRT in case of LBBB with QRS duration &gt;150 ms, lower strength of recommendations, with some heterogeneity, appears when QRS duration is 130–150 ms, especially if not associated with LBBB. Of note, according to recent guidelines, CRT is not recommended in case of QRS duration &lt;130 ms, which is now the lower limit for candidacy to CRT, differently from the 120 ms limit used before. Despite consensus guidelines, many data indicate that CRT is still underused, with great heterogeneity in its implementation, both in North America and Europe, thus requiring a more organized patient referral.

2018 - Cardiac resynchronization therapy: a comparison among left ventricular bipolar, quadripolar and active fixation leads [Articolo su rivista]
Ziacchi, M.; Diemberger, I.; Corzani, A.; Martignani, C.; Mazzotti, A.; Massaro, G.; Valzania, C.; Rapezzi, C.; Boriani, G.; Biffi, M.
abstract

We evaluated the performance of 3 different left ventricular leads (LV) for resynchronization therapy: bipolar (BL), quadripolar (QL) and active fixation leads (AFL). We enrolled 290 consecutive CRTD candidates implanted with BL (n = 136) or QL (n = 97) or AFL (n = 57). Over a minimum 10 months follow-up, we assessed: (a) composite technical endpoint (TE) (phrenic nerve stimulation at 8 V@0.4 ms, safety margin between myocardial and phrenic threshold &lt;2V, LV dislodgement and failure to achieve the target pacing site), (b) composite clinical endpoint (CE) (death, hospitalization for heart failure, heart transplantation, lead extraction for infection), (c) reverse remodeling (RR) (reduction of end systolic volume &gt;15%). Baseline characteristics of the 3 groups were similar. At follow-up the incidence of TE was 36.3%, 14.3% and 19.9% in BL, AFL and QL, respectively (p &lt; 0.01). Moreover, the incidence of RR was 56%, 64% and 68% in BL, AFL and QL respectively (p = 0.02). There were no significant differences in CE (p = 0.380). On a multivariable analysis, “non-BL leads” was the single predictor of an improved clinical outcome. QL and AFL are superior to conventional BL by enhancing pacing of the target site: AFL through prevention of lead dislodgement while QL through improved management of phrenic nerve stimulation.

2018 - Cardiolaminopathies from bench to bedside: challenges in clinical decision-making with focus on arrhythmia-related outcomes [Articolo su rivista]
Boriani, G.; Biagini, E.; Ziacchi, M.; Malavasi, V. L.; Vitolo, Marco; Talarico, Marisa; Mauro, E.; Gorlato, G.; Lattanzi, G.
abstract

Lamin A/C gene mutations can be associated with cardiac diseases, usually referred to as 'cardiolaminopathies' characterized by arrhythmic disorders and/or left ventricular or biventricular dysfunction up to an overt picture of heart failure. The phenotypic cardiac manifestations of laminopathies are frequently mixed in complex clinical patterns and specifically may include bradyarrhythmias (sinus node disease or atrioventricular blocks), atrial arrhythmias (atrial fibrillation, atrial flutter, atrial standstill), ventricular tachyarrhythmias and heart failure of variable degrees of severity. Family history, physical examination, laboratory findings (specifically serum creatine phosphokinase values) and ECG findings are often important 'red flags' in diagnosing a 'cardiolaminopathy'. Sudden arrhythmic death, thromboembolic events or stroke and severe heart failure requiring heart transplantation are the most dramatic complications of the evolution of cardiolaminopathies and appropriate risk stratification is clinically needed combined with clinical follow-up. Treatment with cardiac electrical implantable devices is indicated in case of bradyarrhythmias (implant of a device with pacemaker functions), risk of life-threatening ventricular tachyarrhythmias (implant of an ICD) or in case of heart failure with wide QRS interval (implant of a device for cardiac resynchronization). New technologies introduced in the last 5&nbsp;years can help physicians to reduce device-related complications, thanks to the extension of device longevity and availability of leadless pacemakers or defibrillators, to be implanted in appropriately selected patients. An improved knowledge of the complex pathophysiological pathways involved in cardiolaminopathies and in the determinants of their progression to more severe forms will help to improve clinical management and to better target pharmacological and non-pharmacological treatments.

2018 - Changes to oral anticoagulant therapy and risk of death over a 3-year follow-up of a contemporary cohort of European patients with atrial fibrillation final report of the EURObservational Research Programme on Atrial Fibrillation (EORP-AF) pilot general registry [Articolo su rivista]
Boriani, Giuseppe; Proietti, Marco; Laroche, Cécile; Diemberger, Igor; Popescu, Mircea Ioachim; Riahi, Sam; Shantsila, Alena; Dan, Gheorghe-Andrei; Tavazzi, Luigi; Maggioni, Aldo P.; Lip, Gregory Y. H.
abstract

Background: Contemporary European data regarding patients with atrial fibrillation (AF) allow us to assess the use of oral anticoagulants (OACs) and long-term outcomes. Methods: Patients with AF presenting to cardiologists in 9 European Society of Cardiology participating countries were enrolled and followed-up for 3-years. Results: Among the 2119 patients (40.4% female; mean age 69 ± 11 years) the prevalent types of AF at baseline were first-detected (30.5%) and paroxysmal AF (27.0%). The composite of stroke/TIA/peripheral embolism/all-cause death at 3-years occurred in 18.2%, with first detected AF and permanent AF reporting the highest event rates (22.5% and 27.3%, respectively; p &lt; 0.0001). Age, diabetes mellitus, heart failure, restrictive cardiomyopathy, chronic kidney disease and no physical activity were significant predictors of all-cause death. Paroxysmal and persistent AF patients were more likely to be hospitalised than other types of AF (34.1% and 37.9%, p &lt; 0.0001). At follow-up, OAC drugs were used in 80.1% of patients, with non-vitamin K antagonists (NOACs) accounting for 24.3% of patients. OAC treatment at follow-up visits changed throughout time, with a shift from VKA to NOACs reported in 5.4% of the cases, while the reverse shift (from NOACs to VKA) occurred in 8.6%. Discontinuation of OAC was recorded in while in 9.5% of visits. Conclusions: Patients outcomes at 3-years follow-up differ according to type of AF at baseline, with worse outcomes in patients presenting with first-detected or permanent AF. Changes in the type of OAC use with shifts from NOACs to VKA and vice-versa are not uncommon, as were interruptions of OAC.

2018 - Chronic kidney disease and arrhythmias: Conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference [Articolo su rivista]
Turakhia, Mintu P.; Blankestijn, Peter J.; Carrero, Juan-Jesus; Clase, Catherine M.; Deo, Rajat; Herzog, Charles A.; Kasner, Scott E.; Passman, Rod S.; Pecoits-Filho, Roberto; Reinecke, Holger; Shroff, Gautam R.; Zareba, Wojciech; Cheung, Michael; Wheeler, David C.; Winkelmayer, Wolfgang C.; Wanner, Christoph; Boriani, Giuseppe
abstract

N/A

2018 - Clinical Course and Quality of Life in High-Risk Patients with Hypertrophic Cardiomyopathy and Implantable Cardioverter-Defibrillators [Articolo su rivista]
Maron, Barry J.; Casey, Susan A.; Olivotto, Iacopo; Sherrid, Mark V.; Semsarian, Christopher; Autore, Camillo; Ahmed, Aisha; Boriani, Giuseppe; Francia, Pietro; Winters, Stephen L.; Giudici, Michael; Koulova, Anna; Garberich, Ross; Rowin, Ethan J.; Sears, Samuel F.; Maron, Martin S.; Spirito, Paolo
abstract

Background: High-risk patients with hypertrophic cardiomyopathy (HCM) are identified by contemporary risk stratification and effectively treated with implantable cardioverter-defibrillators (ICDs). However, long-term HCM clinical course after ICD therapy for ventricular tachyarrhythmias is incompletely understood. Methods and Results: Cohort of 486 high-risk HCM patients with ICDs was assembled from 8 international centers. Clinical course and device interventions were addressed, and survey questionnaires assessed patient anxiety level and psychological well-being related to ICD therapy. Of 486 patients, 94 (19%) experienced appropriate ICD interventions terminating ventricular tachycardia/ventricular fibrillation, 3.7% per year for primary prevention, over 6.4±4.7 years. Of 94 patients, 87 were asymptomatic or only mildly symptomatic at the time of appropriate ICD interventions; 74 of these 87 (85%) remained in classes I/II without significant change in clinical status over the subsequent 5.9±4.9 years (up to 22). Among the 94 patients, there was one sudden death (caused by device failure; 1.1%); 3 patients died from other HCM-related processes unrelated to arrhythmic risk (eg, end-stage heart failure). Post-ICD intervention, freedom from HCM mortality was 100%, 97%, and 92% at 1, 5, and 10 years, distinctly lower than in ischemic or nonischemic cardiomyopathy ICD trials. HCM patients with ICD interventions reported heightened anxiety in expectation of future shocks, but with intact general psychological well-being and quality of life. Conclusions: In HCM, unlike ischemic heart disease, prevention of sudden death with ICD therapy is unassociated with significant increase in cardiovascular morbidity or mortality, or transformation to heart failure deterioration. ICD therapy does not substantially impair overall psychological and physical well-being.

2018 - Clinically oriented device programming in bradycardia patients: Part 2 (atrioventricular blocks and neurally mediated syncope). Proposals from AIAC (Italian association of arrhythmology and cardiac pacing) [Articolo su rivista]
Palmisano, Pietro; Ziacchi, Matteo; Biffi, Mauro; Ricci, Renato P.; Landolina, Maurizio; Zoni-Berisso, Massimo; Occhetta, Eraldo; Maglia, Giampiero; Botto, Gianluca; Padeletti, Luigi; Boriani, Giuseppe
abstract

The purpose of this two-part consensus document is to provide specific suggestions (based on an extensive literature review) on appropriate pacemaker setting in relation to patients' clinical features. In part 2, criteria for pacemaker choice and programming in atrioventricular blocks and neurally mediate syncope are proposed. The atrioventricular blocks can be paroxysmal or persistent, isolated or associated with sinus node disease. Neurally mediated syncope can be related to carotid sinus syndrome or cardioinhibitory vasovagal syncope. In sinus rhythm, with persistent atrioventricular block, we considered appropriate the activation of mode-switch algorithms, and algorithms for auto-adaptive management of the ventricular pacing output. If the atrioventricular block is paroxysmal, in addition to algorithms mentioned above, algorithms to maximize intrinsic atrioventricular conduction should be activated. When sinus node disease is associated with atrioventricular block, the activation of rate-responsive function in patients with chronotropic incompetence is appropriate. In permanent atrial fibrillation with atrioventricular block, algorithms for auto-adaptive management of the ventricular pacing output should be activated. If the atrioventricular block is persistent, the activation of rate-responsive function is appropriate. In carotid sinus syndrome, adequate rate hysteresis should be programmed. In vasovagal syncope, specialized sensing and pacing algorithms designed for reflex syncope prevention should be activated.

2018 - Clinically oriented device programming in bradycardia patients: part 1 (sinus node disease). Proposals from AIAC (Italian association of arrhythmology and cardiac pacing) [Articolo su rivista]
Ziacchi, Matteo; Palmisano, Pietro; Biffi, Mauro; Ricci, Renato P.; Landolina, Maurizio; Zoni-Berisso, Massimo; Occhetta, Eraldo; Maglia, Giampiero; Botto, Gianluca; Padeletti, Luigi; Boriani, Giuseppe
abstract

Modern pacemakers have an increasing number of programable parameters and specific algorithms designed to optimize pacing therapy in relation to the individual characteristics of patients. When choosing the most appropriate pacemaker type and programing, the following variables must be taken into account: the type of bradyarrhythmia at the time of pacemaker implantation; the cardiac chamber requiring pacing, and the percentage of pacing actually needed to correct the rhythm disorder; the possible association of multiple rhythm disturbances and conduction diseases; the evolution of conduction disorders during follow-up. The goals of device programing are to preserve or restore the heart rate response to metabolic and hemodynamic demands; to maintain physiological conduction; to maximize device longevity; to detect, prevent, and treat atrial arrhythmia. In patients with sinus node disease, the optimal pacing mode is DDDR. Based on all the available evidence, in this setting, we consider appropriate the activation of the following algorithms: rate responsive function in patients with chronotropic incompetence; algorithms to maximize intrinsic atrioventricular conduction in the absence of atrioventricular blocks; mode-switch algorithms; algorithms for autoadaptive management of the atrial pacing output; algorithms for the prevention and treatment of atrial tachyarrhythmias in the subgroup of patients with atrial tachyarrhythmias/atrial fibrillation. The purpose of this two-part consensus document is to provide specific suggestions (based on an extensive literature review) on appropriate pacemaker setting in relation to patients’ clinical features.

2018 - Comparison of cryoballoon and radiofrequency ablation techniques for atrial fibrillation: a meta-analysis [Articolo su rivista]
Maltoni, Susanna; Negro, Antonella; Camerlingo, Maria D.; Pecoraro, Valentina; Sassone, Biagio; Biffi, Mauro; Boriani, Giuseppe
abstract

AIMS: To perform an updated meta-analysis to assess efficacy, safety and technical performance of pulmonary vein isolation using cryoballoon or radiofrequency catheter ablation in patients with paroxysmal or persistent atrial fibrillation.METHODS: In June 2017, databases and websites were systematically searched for systematic reviews, randomized controlled trials and observational studies reporting data on efficacy, safety and technical performance outcomes at follow-up at least 12 months. Researchers independently assessed records' eligibility, inclusion and methodological quality of included studies.RESULTS: Six randomized controlled trials and 25 observational studies - 11 853 patients were included. Studies on paroxysmal atrial fibrillation were 29 and included 11 635 patients. Meta-analysis results showed no difference between cryoballoon and radiofrequency in terms of recurrent atrial fibrillation [risk ratio 1.04, 95% confidence interval (CI) 0.98-1.10] or atrial tachyarrhythmias (risk ratio 1.04, 95% CI 1-1.08) and fluoroscopy time (mean difference -1.92 min, 95% CI -4.89 to 1.05). Cryoballoon ablation was associated with fewer reablations (risk ratio 0.79, 95% CI 0.64-0.98), lower incidence of pericardial effusion (risk ratio 0.52, 95% CI 0.31-0.89) and cardiac tamponade (risk ratio 0.33, 95% CI 0.18-0.62) and shorter total procedural time (mean difference -23.48 min, 95% CI -37.97; -9.02) but with higher incidence of phrenic nerve palsy (risk ratio 5.43, 95% CI 2.67-11.04). Prespecified subgroup analysis confirmed overall results as for freedom from atrial fibrillation and atrial tachyarrhythmias. Only two observational studies included patients with persistent atrial fibrillation, thus hindering any conclusion in this population.CONCLUSION: In patients with paroxysmal atrial fibrillation, cryoballoon and radiofrequency ablation produce similar results in terms of freedom from recurrent atrial fibrillation or atrial tachyarrhythmias but with a different safety profile, being cryoballoon ablation less associated with cardiac complications but more likely to cause phrenic nerve palsy.

2018 - Contemporary stroke prevention strategies in 11 096 European patients with atrial fibrillation: A report from the EURObservational Research Programme on Atrial Fibrillation (EORP-AF) Long-Term General Registry [Articolo su rivista]
Boriani, Giuseppe; Proietti, Marco; Laroche, Cécile; Fauchier, Laurent; Marin, Francisco; Nabauer, Michael; Potpara, Tatjana; Dan, Gheorghe-Andrei; Kalarus, Zbigniew; Diemberger, Igor; Tavazzi, Luigi; Maggioni, Aldo P.; Lip, Gregory Y. H.
abstract

Aims: Contemporary data regarding atrial fibrillation (AF) management and current use of oral anticoagulants (OACs) for stroke prevention are needed. Methods and results: The EURObservational Research Programme on AF (EORP-AF) Long-Term General Registry analysed consecutive AF patients presenting to cardiologists in 250 centres from 27 European countries. From 2013 to 2016, 11 096 patients were enrolled (40.7% female; mean age 69 ± 11 years). At discharge, OACs were used in 9379 patients (84.9%), with non-vitamin K antagonists (NOACs) accounting for 40.9% of OACs. Antiplatelet therapy alone was used by 20% of patients, while no antithrombotic treatment was prescribed in 6.4%. On multivariable analysis, age, hypertension, previous ischaemic stroke, symptomatic AF and planned cardioversion or ablation were independent predictors of OAC use, whereas lone AF, previous haemorrhagic events, chronic kidney disease and admission for acute coronary syndrome (ACS) or non-cardiovascular causes independently predicted OAC non-use. Regarding the OAC type, coronary artery disease, history of heart failure, or valvular heart disease, planned cardioversion and non-AF reasons for admission independently predicted the use of vitamin K antagonists (VKAs). Wide variability among the European regions was observed in the use of NOACs, independently from other clinical factors. Conclusion: The EORP-AF Long-Term General Registry provides a full picture of contemporary use of OAC in European AF patients. The overall rate of OACs use was generally high (84.9%), and a series of factors were associated with the prescription of OAC. A significant geographical heterogeneity in prescription of NOACs vs. VKAs was evident.

2018 - Detection of new atrial fibrillation in patients with cardiac implanted electronic devices and factors associated with transition to higher device-detected atrial fibrillation burden [Articolo su rivista]
Boriani, Giuseppe; Glotzer, Taya V.; Ziegler, Paul D.; De Melis, Mirko; Mangoni di S. Stefano, Lorenza; Sepsi, Milan; Landolina, Maurizio; Lunati, Maurizio; Lewalter, Thorsten; Camm, A. John
abstract

Background: In patients with cardiac implanted electronic devices, detection of new atrial fibrillation (AF) is associated with an increased risk of stroke. Objective: To characterize daily AF burden at first detection and the rate of temporal transition to higher device-detected AF burden. Methods: A pooled analysis of data from 3 prospective projects was analyzed, and 6580 patients (mean age 68 ± 12 years, 72% male) with no history of AF and no use of anticoagulants at baseline were identified. Various thresholds of daily AF burden (5 minutes and 1, 6, 12, and 23 hours) were analyzed. Results: Among the study population of 6580 patients, a new AF, with an AF burden of ≥5 minutes, was detected in 2244 patients (34%) during a follow-up period of 2.4 ± 1.7 years. Among these patients, 1091 (49.8%) transitioned to a higher AF-burden threshold during follow-up. A higher duration of daily AF burden manifest at first detection and CHADS2 score ≥2 were associated with faster transition to a subsequent higher burden. Approximately 24% of patients transitioned from a lower threshold to a daily AF burden of ≥23 hours during follow-up. Conclusion: More than one-third of patients with no history of AF developed device-detected AF, with attainment of different thresholds of daily AF burden over time. Continuous long-term monitoring, especially when the initial detection corresponds to a higher daily AF burden and the CHADS2 score is ≥2, could support timely clinical decisions on anticoagulation by capturing transitions to higher AF-burden thresholds.

2018 - Efficacy of cardiac resynchronization therapy in patients with isolated ventricular noncompaction with dilated cardiomyopathy: a systematic review of the literature [Articolo su rivista]
Bertini, Matteo; Balla, Cristina; Pavasini, Rita; Boriani, Giuseppe
abstract

: This is a systematic review of current evidence regarding the efficacy of cardiac resynchronization therapy (CRT) on patients with dilated cardiomyopathy and isolated left ventricular noncompaction (IVNC). This systematic review was performed following Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. Records were searched in Pubmed, Cochrane Library, Google Scholar, Biomed Central. We included only studies focused on ventricular noncompaction patients treated with CRT. Of 46 records screened, we included 14 studies involving a total of 70 patients. All studies showed a reduction of New York Heart Association class and an increase of the ejection fraction that ranges from 8 to 36% at follow-up after CRT. Analyzing the type of response to CRT, approximately 50% of the patients were classified as responders to the therapy and most of them were super-responders. In conclusion, CRT provides beneficial effects in terms of clinical status and left ventricular function on IVNC patients with heart failure. CRT responders seem to have a great left ventricular reverse remodeling supporting the theory that CRT is able to provide an additional benefit in the IVNC disease, improving the performance of IVNC segments, when paced.

2018 - Elevated TGF β2 serum levels in Emery-Dreifuss Muscular Dystrophy: Implications for myocyte and tenocyte differentiation and fibrogenic processes [Articolo su rivista]
Bernasconi, Pia; Carboni, Nicola; Ricci, Giulia; Siciliano, Gabriele; Politano, Luisa; Maggi, Lorenzo; Mongini, Tiziana; Vercelli, Liliana; Rodolico, Carmelo; Biagini, Elena; Boriani, Giuseppe; Ruggiero, Lucia; Santoro, Lucio; Schena, Elisa; Prencipe, Sabino; Evangelisti, Camilla; Pegoraro, Elena; Morandi, Lucia; Columbaro, Marta; Lanzuolo, Chiara; Sabatelli, Patrizia; Cavalcante, Paola; Cappelletti, Cristina; Bonne, Gisèle; Muchir, Antoine; Lattanzi, Giovanna
abstract

Among rare diseases caused by mutations in LMNA gene, Emery-Dreifuss Muscular Dystrophy type 2 and Limb-Girdle muscular Dystrophy 1B are characterized by muscle weakness and wasting, joint contractures, cardiomyopathy with conduction system disorders. Circulating biomarkers for these pathologies have not been identified. Here, we analyzed the secretome of a cohort of patients affected by these muscular laminopathies in the attempt to identify a common signature. Multiplex cytokine assay showed that transforming growth factor beta 2 (TGF β2) and interleukin 17 serum levels are consistently elevated in the vast majority of examined patients, while interleukin 6 and basic fibroblast growth factor are altered in subgroups of patients. Levels of TGF β2 are also increased in fibroblast and myoblast cultures established from patient biopsies as well as in serum from mice bearing the H222P Lmna mutation causing Emery-Dreifuss Muscular Dystrophy in humans. Both patient serum and fibroblast conditioned media activated a TGF β2-dependent fibrogenic program in normal human myoblasts and tenocytes and inhibited myoblast differentiation. Consistent with these results, a TGF β2 neutralizing antibody avoided fibrogenic marker activation and myogenesis impairment. Cell intrinsic TGF β2-dependent mechanisms were also determined in laminopathic cells, where TGF β2 activated AKT/mTOR phosphorylation. These data show that TGF β2 contributes to the pathogenesis of Emery-Dreifuss Muscular Dystrophy type 2 and Limb-Girdle muscular Dystrophy 1B and can be considered a potential biomarker of those diseases. Further, the evidence of TGF β2 pathogenetic effects in tenocytes provides the first mechanistic insight into occurrence of joint contractures in muscular laminopathies.

2018 - European Heart Rhythm Association (EHRA) consensus document on the management of supraventricular arrhythmias, endorsed by Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulación Cardiaca y Electrofisiologia (SOLAECE) [Articolo su rivista]
Katritsis, Demosthenes G.; Boriani, Giuseppe; Cosio, Francisco G.; Hindricks, Gerhard; Jais, Pierre; Josephson, Mark E.; Keegan, Roberto; Kim, Young-Hoon; Knight, Bradley P.; Kuck, Karl-Heinz; Lane, Deirdre A.; Lip, Gregory Y. H.; Malmborg, Helena; Oral, Hakan; Pappone, Carlo; Themistoclakis, Sakis; Wood, Kathryn A.; Blomström-Lundqvist, Carina
abstract

NA

2018 - European Heart Rhythm Association (EHRA) position paper on arrhythmia management and device therapies in endocrine disorders, endorsed by Asia Pacific Heart Rhythm Society (APHRS) and Latin American Heart Rhythm Society (LAHRS) [Articolo su rivista]
Gorenek, Bulent; Boriani, Giuseppe; Dan, Gheorge-Andrei; Fauchier, Laurent; Fenelon, Guilherme; Huang, He; Kudaiberdieva, Gulmira; Lip, Gregory Y. H.; Mahajan, Rajiv; Potpara, Tatjana; Ramirez, Juan David; Vos, Marc A.; Marin, Francisco; Blomstrom-Lundqvist, Carina; Rinaldi, Aldo; Bongiorni, Maria Grazia; Sciaraffia, Elena; Nielsen, Jens Cosedis; Lewalter, Thorsten; Zhang, Shu; Gutiérrez, Oswaldo; Fuenmayor, Abdel
abstract

Endocrine disorders are associated with various tachyarrhythmias, including atrial fibrillation (AF), ventricular tachycardia (VT), ventricular fibrillation (VF), and bradyarrhythmias. Along with underlying arrhythmia substrate, electrolyte disturbances, glucose, and hormone levels, accompanying endocrine disorders contribute to development of arrhythmia. Arrhythmias may be life-threatening, facilitate cardiogenic shock development and increase mortality. The knowledge on the incidence of tachy- and bradyarrhythmias, clinical and prognostic significance as well as their management is limited; it is represented in observational studies and mostly in case reports on management of challenging cases. It should be also emphasized, that the topic is not covered in detail in current guidelines. Therefore, cardiologists and multidisciplinary teams participating in care of such patients do need the evidence-based, or in case of limited evidence expert-opinion based recommendations, how to treat arrhythmias using contemporary approaches, prevent their complications and recurrence in patients with endocrine disorders. In recognizing this close relationship between endocrine disorders and arrhythmias, the European Heart Rhythm Association (EHRA) convened a Task Force, with representation from Asia-Pacific Heart Rhythm Society (APHRS) and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLAECE), with the remit of comprehensively reviewing the available evidence and publishing a joint consensus document on endocrine disorders and cardiac arrhythmias, and providing up-to-date consensus recommendations for use in clinical practice.

2018 - European Society of Cardiology-Proposed Diagnostic Echocardiographic Algorithm in Elective Patients with Clinical Suspicion of Infective Endocarditis: Diagnostic Yield and Prognostic Implications in Clinical Practice [Articolo su rivista]
Barbieri, A.; Mantovani, F.; Lugli, R.; Bursi, F.; Fabbri, M.; Bartolacelli, Y.; Manicardi, M.; Stefanelli, G.; Mussini, C.; Boriani, G.
abstract

Echocardiography plays a central role in diagnosing infective endocarditis (IE). Accordingly, the European Society of Cardiology (ESC) has proposed a diagnostic echocardiographic algorithm. However, new studies are still needed to evaluate the degree of implementation of these guidelines in clinical practice and their consequences on incidence and prognosis of IE.

2018 - European Society of Cardiology: Cardiovascular disease statistics 2017 [Articolo su rivista]
Timmis, Adam; Townsend, Nick; Gale, Chris; Grobbee, Rick; Maniadakis, Nikos; Flather, Marcus; Wilkins, Elizabeth; Wright, Lucy; Vos, Rimke; Bax, Jeroen; Blum, Maxim; Pinto, Fausto; Vardas, Panos; Boriani, Giuseppe
abstract

Aims: The European Society of Cardiology (ESC) Atlas has been compiled by the European Heart Agency to document cardiovascular disease (CVD) statistics of the 56 ESC member countries. A major aim of this 2017 data presentation has been to compare high-income and middle-income ESC member countries to identify inequalities in disease burden, outcomes, and service provision. Methods and results: The Atlas utilizes a variety of data sources, including the World Health Organization, the Institute for Health Metrics and Evaluation, and the World Bank to document risk factors, prevalence, and mortality of cardiovascular disease and national economic indicators. It also includes novel ESC-sponsored survey data of health infrastructure and cardiovascular service provision provided by the national societies of the ESC member countries. Data presentation is descriptive with no attempt to attach statistical significance to differences observed in stratified analyses. Important differences were identified between the high-income and middle-income member countries of the ESC with regard to CVD risk factors, disease incidence, and mortality. For both women and men, the age-standardized prevalence of hypertension was lower in high-income countries (18% and 27%) compared with middle-income countries (24% and 30%). Smoking prevalence in men (not women) was also lower (26% vs. 41%) and together these inequalities are likely to have contributed to the higher CVD mortality in middle-income countries. Declines in CVD mortality have seen cancer becoming a more common cause of death in a number of high-income member countries, but in middle-income countries declines in CVD mortality have been less consistent where CVD remains the leading cause of death. Inequalities in CVD mortality are emphasized by the smaller contribution they make to potential years of life lost in high-income countries compared with middle-income countries both for women (13% vs. 23%) and men (20% vs. 27%). The downward mortality trends for CVD may, however, be threatened by the emerging obesity epidemic that is seeing rates of diabetes increasing across all the ESC member countries. Survey data from the National Cardiac Societies showed that rates of cardiac catheterization and coronary artery bypass surgery, as well as the number of specialist centres required to deliver them, were greatest in the high-income member countries of the ESC. The Atlas confirmed that these ESC member countries, where the facilities for the contemporary treatment of coronary disease were best developed, were often those in which declines in coronary mortality have been most pronounced. Economic resources were not the only driver for delivery of equitable cardiovascular health care, as some middle-income ESC member countries reported rates for interventional procedures and device implantations that matched or exceeded the rates in wealthier member countries. Conclusion: In documenting national CVD statistics, the Atlas provides valuable insights into the inequalities in risk factors, health care delivery, and outcomes of CVD across the ESC member countries. The availability of these data will underpin the ESC's ambitious mission 'to reduce the burden of cardiovascular disease' not only in its member countries but also in nation states around the world.

2018 - Extending survival by reducing sudden death with implantable cardioverter-defibrillators: a challenging clinical issue in non-ischaemic and ischaemic cardiomyopathies [Articolo su rivista]
Boriani, Giuseppe; Malavasi, Vincenzo Livio
abstract

NA

2018 - Five year trends (2008-2012) in cardiac implantable electrical device utilization in five European nations: A case study in cross-country comparisons using administrative databases [Articolo su rivista]
Banks, Helen; Torbica, Aleksandra; Valzania, Cinzia; Varabyova, Yauheniya; Prevolnik Rupel, Valentina; Taylor, Rod S; Hunger, Theresa; Walker, Simon; Boriani, Giuseppe; Fattore, Giovanni
abstract

Aims Common methodologies for analysis of analogous data sets are needed for international comparisons of treatment and outcomes. This study tests using administrative hospital discharge (HD) databases in five European countries to investigate variation/trends in pacemaker (PM) and implantable cardioverter defibrillator (ICD) implant rates in terms of patient characteristics/management, device subtype, and initial implantation vs. replacement, and compares findings with existing literature and European Heart Rhythm Association (EHRA) reports. Methods and results HD databases from 2008 to 2012 in Austria, England, Germany, Italy and Slovenia were interrogated to extract admissions (without patient identification) associated with PM and ICD implants and replacements, using direct cross-referencing of procedure codes and common methodology to compare aggregate data. 1 338 199 records revealed 212 952 PM and 62 567 ICD procedures/year on average for a 204.4 million combined population, a crude implant rate of about 104/100 000 inhabitants for PMs and 30.6 for ICDs. The first implant/replacement rate ratios were 81/24 (PMs) and 25/7 (ICDs). Rates have increased, with cardiac resynchronization therapy (CRT) subtypes for both devices rising dramatically. Significant between- and within-country variation persists in lengths of stay and rates (Germany highest, Slovenia lowest). Adjusting for age lessened differences for PM rates, scarcely affected ICDs. Male/female ratios remained stable at 56/44% (PMs) and 79/21% (ICDs). About 90% of patients were discharged to home; 85-100% were inpatient admissions. Conclusion To aid in policymaking and track outcomes, HD administrative data provides a reliable, relatively cheap, methodology for tracking implant rates for PMs and ICDs across countries, as comparisons to EHRA data and the literature indicated.

2018 - Health care cost analysis of enhanced pacing modalities in bradycardia patients: Portuguese case study on the results of the MINERVA trial [Articolo su rivista]
de Sousa, João; Marques, Pedro; Martins, Vítor; Hipólito-Reis, António; Duarte, Luís; Joaquim, Inês; Monteiro, Diogo; Boriani, Giuseppe; Wolff, Claudia; Grammatico, Andrea; Padeletti, Luigi
abstract

Introduction: The MINERVA trial established that atrial preventive pacing and atrial antitachycardia pacing (DDDRP) in combination with managed ventricular pacing (MVP) reduces progression to permanent atrial fibrillation (AF) in patients with paroxysmal or persistent AF and bradycardia who need cardiac pacing, compared to standard dual-chamber pacing (DDDR). It was shown that AF-related health care utilization was significantly lower in the DDDRP + MVP group than in the control group. Cost analysis demonstrated significant savings related to this new algorithm, based on health care costs from the USA, Italy, Spain and the UK. Objective: To calculate the savings associated with reduced health care utilization due to enhanced pacing modalities in the Portuguese setting. Methods: The impact on costs was estimated based on tariffs for AF-related hospitalizations and costs for emergency department and outpatient visits in Portugal. Results: The MINERVA trial showed a 42% reduction in AF-related health care utilization thanks to the new algorithm. In Portugal, this represents a potential cost saving of 2323 euros per 100 patients in the first year and 17 118 euros over a 10-year period. Considering the number of patients who could benefit from this new algorithm, Portugal could save a total of 75 369 euros per year and 555 410 euros over 10 years. Additional savings could accrue if heart failure and stroke hospitalizations were considered. Conclusion: The combination of atrial preventive pacing, atrial antitachycardia pacing and an algorithm to minimize the detrimental effect of right ventricular pacing reduces recurrent and permanent AF. The new DDDRP + MVP pacing mode could contribute to significant costs savings in the Portuguese health care setting.

2018 - Impact of pacemaker longevity on expected device replacement rates: Results from computer simulations based on a multicenter registry (ESSENTIAL) [Articolo su rivista]
Boriani, Giuseppe; Bertini, Matteo; Saporito, Davide; Belotti, Giuseppina; Quartieri, Fabio; Tomasi, Corrado; Pucci, Angelo; Boggian, Giulio; Mazzocca, Gian Franco; Giorgi, Davide; Diotallevi, Paolo; Sassone, Biagio; Grassini, Diego; Gargaro, Alessio; Biffi, Mauro
abstract

Background: The rate of device replacement in pacemaker recipients has not been investigated in detail. Hypothesis: Current pacemakers with automatic management of atrial and ventricular pacing output provide sufficient longevity to minimize replacement rate. Methods: We considered a cohort of 542 pacemaker patients (age 78 ± 9 years, 60% male, 71% de-novo implants) and combined 1-month projected device longevity with survival data and late complication rate in a 3-state Markov model tested in several Monte Carlo computer simulations. Predetermined subgroups were: age &lt; or ≥ 70; gender; primary indication to cardiac pacing. Results: At the 1-month follow-up the reported projected device longevity was 153 ± 45 months. With these values the proportion of patients expected to undergo a device replacement due to battery depletion was higher in patients aged &lt;70 (49.9%, range 32.1%-61.9%) than in age ≥70 (24.5%, range 19.9%-28.8%); in women (39.9%, range 30.8%-48.1%) than in men (32.0%, range 24.7%-37.5%); in sinus node dysfunction (41.5%, range 30.2%-53.0%) than in atrio-ventricular block (33.5%, range 27.1-38.8%) or atrial fibrillation with bradycardia (27.9%, range 18.5%-37.0%). The expected replacement rate was inversely related to the assumed device longevity and depended on age class: a 50% increase in battery longevity implied a 5% reduction of replacement rates in patients aged ≥80. Conclusions: With current device technology 1/4 of pacemaker recipients aged ≥70 are expected to receive a second device in their life. Replacement rate depends on age, gender, and primary indication owing to differences in patients' survival expectancy. Additional improvements in device service time may modestly impact expected replacement rates especially in patients ≥80 years.

2018 - Implantable cardioverter-defibrillator–computed respiratory disturbance index accurately identifies severe sleep apnea: The DASAP-HF study [Articolo su rivista]
D'Onofrio, Antonio; La Rovere, Maria Teresa; Emdin, Michele; Capucci, Alessandro; Sinagra, Gianfranco; Bianchi, Valter; Pisanò, Ennio C. L.; Pieragnoli, Paolo; Tespili, Maurizio; Luzi, Mario; Talarico, Antonello; Zecchin, Massimo; Rapacciuolo, Antonio; Piacenti, Marcello; Indolfi, Ciro; Arias, Miguel Angel; Diemberger, Igor; Checchinato, Catia; Boriani, Giuseppe; Padeletti, Luigi
abstract

Background: Sleep apnea (SA) is a relevant issue in the management of patients with heart failure for risk stratification and for implementing treatment strategies. Objective: The purpose of this study was to evaluate in patients with implantable cardioverter-defibrillators (ICDs) the performance of the respiratory disturbance index (RDI) computed by the ApneaScan algorithm (Boston Scientific Inc., Natick, MA) as a discriminator of severe SA. Methods: ICD-indicated patients with left ventricular ejection fraction ≤35% were enrolled. One month after implantation, patients underwent a polysomnographic study. We evaluated the accuracy of the RDI for the prediction of severe SA (apnea-hypopnea index [AHI] ≥30 episodes/h) and the agreement between RDI and AHI during the sleep study night. Results: Two hundred sixty-five patients were enrolled to obtain the required sample of 173 patients with AHI and RDI data for analysis. The mean AHI was 21 ± 15 episodes/h and severe SA was diagnosed in 38 patients (22%), while the mean RDI was 33 ± 13 episodes/h. On the basis of the receiver operating characteristic curve analysis of RDI values, the area under the curve was 0.77 (95% confidence interval [CI] 0.70–0.83; P &lt;.001). At an RDI value of 31 episodes/h, severe SA was detected with 87% (95% CI 72%–96%) sensitivity and 56% (95% CI 48%–66%) specificity. RDI closely correlated with AHI recorded during the same night (r = 0.74; 95% CI 0.57–0.84; P &lt;.001), and the Bland-Altman agreement analysis revealed a bias of 11 episodes/h, with limits of agreement being −10 to 32 episodes/h. Conclusion: The RDI accurately identified severe SA and demonstrated good agreement with AHI. Therefore, it may serve as an efficient tool for screening patients at risk of SA.

2018 - Increased burden of comorbidities and risk of cardiovascular death in atrial fibrillation patients in Europe over ten years: A comparison between EORP-AF pilot and EHS-AF registries [Articolo su rivista]
Proietti, Marco; Laroche, Cécile; Nieuwlaat, Robby; Crijns, Harry J. G. M.; Maggioni, Aldo P.; Lane, Deirdre A.; Boriani, Giuseppe; Lip, Gregory Y. H.
abstract

Background: In 2002, the European Society of Cardiology conducted the Euro Heart Survey (EHS), while in 2014concluded 1-year follow-up of the EURObservational Research Programme AF (EORP-AF) Pilot Registry. Methods: We analysed differences in clinical profiles, therapeutic approaches and outcomes between these two cohorts after propensity score matching (PSM). Results: After PSM, 5206 patients were analysed. In EORP-AF there were more elderly patients than EHS (p &lt;.001). EORP-AF patients were more burdened with cardiovascular (CV) and non-CV comorbidities, with a higher proportion of patients with high thromboembolic risk. EORP-AF patients used more oral-anticoagulant (OAC) (p &lt;.001). At 1-year follow-up EORP-AF patients had lower risk for thromboembolic and CV events, readmission for AF and other CV reasons (all p &lt;.001), showing conversely a higher risk for CV death (p =.015). Kaplan-Meier curves showed that EORP-AF patients had higher risk for CV death (p &lt;.0001) and all-cause death (p =.0019). Cox regression confirmed that EORP-AF patients were at higher risk for CV death (p =.021). Conclusions: We found significant changes in AF epidemiology over a decade in Europe, with older patients, more burdened with comorbidities. A greater use of OAC was found. Despite a reduction in risk for thromboembolic events, a high risk of CV-related death was still evident.

2018 - Integrating new approaches to atrial fibrillation management: The 6th AFNET/EHRA Consensus Conference [Articolo su rivista]
Kotecha, Dipak; Breithardt, Günter; Camm, A. John; Lip, Gregory Y. H.; Schotten, Ulrich; Ahlsson, Anders; Arnar, David; Atar, Dan; Auricchio, Angelo; Bax, Jeroen; Benussi, Stefano; Blomstrom-Lundqvist, Carina; Borggrefe, Martin; Boriani, Giuseppe; Brandes, Axel; Calkins, Hugh; Casadei, Barbara; Castellá, Manuel; Chua, Winnie; Crijns, Harry; Dobrev, Dobromir; Fabritz, Larissa; Feuring, Martin; Freedman, Ben; Gerth, Andrea; Goette, Andreas; Guasch, Eduard; Haase, Doreen; Hatem, Stephane; Haeusler, Karl Georg; Heidbuchel, Hein; Hendriks, Jeroen; Hunter, Craig; Kääb, Stefan; Kespohl, Stefanie; Landmesser, Ulf; Lane, Deirdre A.; Lewalter, Thorsten; Mont, Lluís; Nabauer, Michael; Nielsen, Jens C.; Oeff, Michael; Oldgren, Jonas; Oto, Ali; Pison, Laurent; Potpara, Tatjana; Ravens, Ursula; Richard-Lordereau, Isabelle; Rienstra, Michiel; Savelieva, Irina; Schnabel, Renate; Sinner, Moritz F.; Sommer, Philipp; Themistoclakis, Sakis; Van Gelder, Isabelle C.; Vardas, Panagiotis E.; Verma, Atul; Wakili, Reza; Weber, Evelyn; Werring, David; Willems, Stephan; Ziegler, André; Hindricks, Gerhard; Kirchhof, Paulus
abstract

There are major challenges ahead for clinicians treating patients with atrial fibrillation (AF). The population with AF is expected to expand considerably and yet, apart from anticoagulation, therapies used in AF have not been shown to consistently impact on mortality or reduce adverse cardiovascular events. New approaches to AF management, including the use of novel technologies and structured, integrated care, have the potential to enhance clinical phenotyping or result in better treatment selection and stratified therapy. Here, we report the outcomes of the 6th Consensus Conference of the Atrial Fibrillation Network (AFNET) and the European Heart Rhythm Association (EHRA), held at the European Society of Cardiology Heart House in Sophia Antipolis, France, 17-19 January 2017. Sixty-two global specialists in AF and 13 industry partners met to develop innovative solutions based on new approaches to screening and diagnosis, enhancing integration of AF care, developing clinical pathways for treating complex patients, improving stroke prevention strategies, and better patient selection for heart rate and rhythm control. Ultimately, these approaches can lead to better outcomes for patients with AF.

2018 - Is ventricular sensing always right, when it is left? [Articolo su rivista]
Biffi, Mauro; de Zan, Giulia; Massaro, Giulia; Angeletti, Andrea; Martignani, Cristian; Boriani, Giuseppe; Diemberger, Igor; Ziacchi, Matteo
abstract

Background: Ventricular sensing in transvenous cardiac implantable electronic devices (CIEDs) occurs conventionally from the right ventricular (RV) channel, though it evolved from epicardial sensing both in pacemakers and implantable cardioverter-defibrillators (ICDs). Hypothesis: The objective of this study was to observe the reliability of left ventricular (LV) sensing by transvenous leads placed in coronary veins. Methods: LV leads were used for sensing and arrhythmia detection in clinical situations where placement of an RV lead across the tricuspid valve was either not preferred or not feasible, or RV signal was unsuitable for arrhythmia detection, or in the event of sensing failure of an RV lead under advisory in cardiac resynchronization therapy defibrillator (CRTD) recipients. Results: Thirty-seven patients had an IS-1 LV lead connected to the RV port of CIEDs (17 pacemakers, 5 cardiac resynchronization therapy pacemaker [CRTP], 2 ICDs, and 13 CRTDs). Along a median 41 (25-67) months follow-up, lead performance remained stable; there were neither undersensing nor oversensing of non-cardiac signals. VT/VF were correctly detected and terminated by ATP and shocks (one and three patients, respectively); no inappropriate arrhythmia detection. Device reprogramming occurred in four CRTD recipients because of transient counting the QRS (short intervals) when paced in LV-only, and in two with T-wave oversensing. Conclusions: Ventricular sensing by an LV lead is feasible in transvenous devices. Sensing programmability is an unmet need: to fix RV lead sensing issues in cardiac resynchronization therapy (CRT) recipients at no risk of infection (no pocket opening); to avoid interaction with the tricuspid valve; to avoid lead redundancy in the vasculature. Moreover, it will be mandatory owing to the loss of lead interchangeability due to the adoption of DF-4 and quadripolar leads.

2018 - Letter responding to Screening for atrial fibrillation: A European Heart Rhythm Association (EHRA) consensus document endorsed by the Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), and Societad Latinoamericana de Estimulation Cardiaca y Electrofisiologia (SOLAECE) - Authors' reply [Articolo su rivista]
Mairesse, Georges H.; Boriani, Giuseppe
abstract

NA

2018 - Long-term progression of rhythm and conduction disturbances in pacemaker recipients: findings from the Pacemaker Expert Programming study [Articolo su rivista]
Palmisano, Pietro; Ziacchi, Matteo; Ammendola, Ernesto; Dell'Era, Gabriele; Guerra, Federico; Aspromonte, Vittorio; Boriani, Giuseppe; Nigro, Gerardo; Occhetta, Eraldo; Capucci, Alessandro; Ricci, Renato Pietro; Maglia, Giampiero; Biffi, Mauro; Accogli, Michele
abstract

AIMS: Knowledge of the long-term progression of rhythm disorders requiring pacemaker implantation could have significant implications for the choice of device and its management during follow-up. Accordingly, we conducted an observational study to analyse the long-term progression of rhythm disorders requiring pacemaker implantation. METHODS: This multicentre, observational study enrolled 1810 pacemaker patients (age 71.6 ± 13.3 years, men 53.8%) consecutively evaluated during scheduled pacemaker follow-up visits. To evaluate the long-term progression of rhythm disorders, we analysed the patient's rhythm disorders at the time of device implantation and during follow-up. After pacemaker implantation, the rhythm disorders were reassessed and recorded at each scheduled pacemaker follow-up visit, and the spontaneous rhythm was analysed during pacemaker interrogation. RESULTS: During a median follow-up of 61.6 months, we observed a progression of the primary rhythm disorder in 295 patients (16.3%; worsening of the preexisting rhythm disorder in 7.7%; occurrence of a new rhythm disorder added to the preexisting one in 8.6%). Specifically, the cumulative per-year risks of developing the following disorders were: atrioventricular block (AVB) in patients implanted for sinus node disease (SND), 0.3%; permanent atrial fibrillation in SND patients, 2.9%; SND in AVB patients, 0.7%; and persistent AVB in patients implanted for chronic bifascicular block 3.0%. CONCLUSION: Our results revealed that rhythm disorders requiring pacemaker implantation show long-term progression in a significant number of cases. In many cases, the progression is substantial and may require a change in pacing mode.

2018 - Management and prognosis of atrial fibrillation in diabetic patients: An EORP-AF General Pilot Registry report [Articolo su rivista]
Fumagalli, Stefano; Said, Salah A.; Laroche, Cecile; Gabbai, Debbie; Boni, Serena; Marchionni, Niccolò; Boriani, Giuseppe; Maggioni, Aldo P.; Musialik-Lydka, Agata; Sokal, Adam; Petersen, Jens; Crijns, Harry J. G. M; Lip, Gregory Y. H.
abstract

Aims Diabetes mellitus (DM) is one of the most important cardiovascular risk factors. The aim of this study was to evaluate clinical correlates of DM, including management and outcomes, in the EURObservational Research Programme (EORP)-Atrial Fibrillation (AF) General Pilot (EORP-AF) Registry of the European Society of Cardiology. Methods and results We studied consecutive patients (N= 3101) enrolled in 70 centres of nine European countries between February 2012 and March 2013, and compared diabetics with non-diabetics during a 1-year follow-up. In the overall cohort, the prevalence of DM was 20.6%. Diabetics were older (71 ± 9 vs. 68 ± 12 years, P &lt; 0.0001) and had more comorbidities, higher CHA2DS2-VASc score (4.6 ± 1.6 vs. 2.9 ± 1.7, P &lt; 0.0001) and higher prevalence of permanent AF (21.5 vs. 16.0%, P = 0.0022). Quality of life amongst DM patients was significantly worse [atrial fibrillation quality of life questionnaire (AF-QoL) score 45.2 ± 19.2 vs. 49.3 ± 20.1, P &lt; 0.0001]. Amongst diabetics, the use of electrical cardioversion (16.2 vs. 24.6%, P &lt; 0.0001) and catheter ablation (3.3 vs. 8.6%, P &lt; 0.0001) was lower, whilst oral anticoagulants were more often prescribed (84.3 vs. 78.9%, P = 0.0027). After one year, diabetic patients had significantly higher all-cause (11.9 vs. 4.9%, P &lt; 0.0001), cardiovascular (6.2 vs. 1.9%, P &lt; 0.0001), and non-cardiovascular mortality (2.3 vs. 1.1%, P = 0.0356). Conclusion In AF patients, DM is associated with a higher prevalence of comorbidities and a worse quality of life. After one year, all-cause, cardiovascular, and non-cardiovascular mortality were significantly higher in diabetic subjects.

2018 - Management of cardiopulmonary disease in patients with systemic sclerosis: cardiorheumatology clinic and patient care standardization proposal [Articolo su rivista]
Spinella, Amelia; Coppi, Francesca; Mattioli, Anna Vittoria; Lumetti, Federica; Rossi, Rosario; Cocchiara, Emanuele; Colaci, Michele; Boriani, Giuseppe; Ferri, Clodoveo; Salvarani, Carlo; Giuggioli, Dilia
abstract

Management of cardiopulmonary disease in patients with systemic sclerosis: cardiorheumatology clinic and patient care standardization proposal

2018 - Management of patients with cardiac implantable electronic devices (CIED) undergoing radiotherapy: A consensus document from Associazione Italiana Aritmologia e Cardiostimolazione (AIAC), Associazione Italiana Radioterapia Oncologica (AIRO), Associazione Italiana Fisica Medica (AIFM) [Articolo su rivista]
Zecchin, Massimo; Severgnini, Mara; Fiorentino, Alba; Malavasi, Vincenzo Livio; Menegotti, Loris; Alongi, Filippo; Catanzariti, Domenico; Jereczek-Fossa, Barbara Alicja; Stasi, Michele; Russi, Elvio; Boriani, Giuseppe
abstract

The management of patients with a cardiac implanted electronic device (CIED) receiving radiotherapy (RT) is challenging and requires a structured multidisciplinary approach. A consensus document is presented as a result of a multidisciplinary working group involving cardiac electrophysiologists, radiation oncologists and physicists in order to stratify the risk of patients with CIED requiring RT and approaching RT sessions appropriately. When high radiation doses and beam energy higher than 6 MV are used, CIED malfunctions can occur during treatment. In our document, we reviewed the different types of RT and CIED behavior in the presence of ionizing radiations and electromagnetic interferences, from the cardiologist's, radiation oncologist's and medical physicist's point of view. We also reviewed in vitro and in vivo literature data and other national published guidelines on this issue so far. On the basis of literature data and consensus of experts, a detailed approach based on risk stratification and appropriate management of RT patients with CIEDs is suggested, with important implications for clinical practice.

2018 - Meta-analysis of clinical outcomes of electrical cardioversion and catheter ablation in patients with atrial fibrillation and chronic kidney disease [Articolo su rivista]
Diemberger, Igor; Genovesi, Simonetta; Massaro, Giulia; Reggiani, Maria Letizia Bacchi; Frisoni, Jessica; Gorlato, Giulia; Mauro, Erminio; Padeletti, Margherita; Vincenti, Antonio; Boriani, Giuseppe
abstract

Background: Chronic kidney disease (CKD) is associated with adverse outcomes in presence of atrial fibrillation (AF). However, the literature shows limited data on non-pharmacological management of AF in CKD patients. Aim: summarizing the available data on outcomes associated with electrical cardioversion (ECV) and AF catheter ablation (CA) in CKD patients. Methods: We searched MEDLINE and the Cochrane Central Register of Controlled Trials and performed a meta-analysis. The primary outcome was recurrence of AF. The secondary outcomes were occurrence of thromboembolic events (TEs) and estimated glomerular filtration rate (eGFR) modification. Results: Literature search yielded 26 eligible papers: 22 on CA and 4 concerning ECV. CKD patients presented more AF recurrences 30 days after ECV (OR 2.62, 95%CI 1.28-5.34; p <0.001). Patients with eGFR<60-68 ml/min and on dialysis presented a higher incidence of AF recurrences after CA, median follow up 26.0 and 29.9 months (HR 1.75, 95%CI 1.46-2.09, p <0.001; and HR 1.69, 95%CI 1.22-2.33, p <0.001; respectively). Peri-procedural TEs were rare and not associated with CKD or dialysis. However, patients with CKD were at increased risk for delayed TEs after CA (HR 2.61, 95%CI 1.04-6.54; p <0.001). No significant modification of eGFR was associated with ECV or CA in the overall population. Conclusion: ECV and CA for sinus rhythm restoration/maintenance in AF patients, albeit theoretically promising, seem to be associated with lower efficacy at medium to long-term in patients with CKD. Further studies are needed to better define the role of ECV and CA in CKD.

2018 - Overweight and obesity in patients with atrial fibrillation: Sex differences in 1-year outcomes in the EORP-AF General Pilot Registry [Articolo su rivista]
Boriani, Giuseppe; Laroche, Cécile; Diemberger, Igor; Fantecchi, Elisa; Meeder, Joan; Kurpesa, Malgorzata; Baluta, Monica Mariana; Proietti, Marco; Tavazzi, Luigi; Maggioni, Aldo P.; Lip, Gregory Y. H.
abstract

Background: The impact of overweight and obesity on outcomes in “real world” patients with atrial fibrillation (AF) is not fully defined. Second, sex differences in AF outcomes may also exist. Methods and results: The aim was to investigate outcomes at 1 year follow-up for AF patients enrolled in the EORP-AF Registry, according to BMI (kg/m2), comparing patients with normal BMI (18.5 to&nbsp;&lt;&nbsp;25&nbsp;kg/m2), overweight (25 to&nbsp;&lt;&nbsp;30&nbsp;kg/m2) and obesity (≥ 30&nbsp;kg/m2), in relation to sex differences. Among 2,540 EORP AF patients (38.9% female; median age 69) with 1 year follow-up data available, 720 (28.3%) had a normal BMI, 1,084 (42.7%) were overweight, and 736 (29.0%) were obese. Obese patients were younger and with more prevalent diabetes mellitus and hypertension (P&nbsp;&lt;&nbsp;0. 001). One-year outcomes showed that all-cause mortality was significantly different according to BMI among female patients (9.3% normal BMI, 5.3% overweight, and 4.3 % obese, P&nbsp;=&nbsp;0.023), but not among male patients (P&nbsp;=&nbsp;0.748). The composite outcome of thromboembolic events and death was also significantly different, being lower in obese females (P&nbsp;=&nbsp;0.035). Among male patients, bleeding events were significantly more frequent in obese subjects (P&nbsp;=&nbsp;0.035). On multivariable Cox analysis, BMI was not independently associated with all-cause mortality. Conclusions: Among AF patients, overweight and obesity are common and associated with better outcomes in females (a finding previously reported as “obesity paradox”), while no significant differences in outcomes are detected among male patients. Final multivariable model found that increasing BMI was not associated with increased risk of all-cause death; conversely, age and comorbidities persisted as major determinants.

2018 - Pacemaker-detected severe sleep apnoea predicts new-onset atrial fibrillation: Author's reply [Articolo su rivista]
Mazza, Andrea; Bendini, Maria Grazia; De Cristofaro, Raffaele; Lovecchio, Mariolina; Valsecchi, Sergio; Boriani, Giuseppe
abstract

NA

2018 - Performance and clinical comparison between left ventricular quadripolar and bipolar leads in cardiac resynchronization therapy: Observational research [Articolo su rivista]
Ziacchi, M.; Zucchelli, G.; Ricciardi, D.; Morani, G.; De Ruvo, E.; Calzolari, V.; Viani, S.; Calabrese, V.; Tomasi, L.; Calo, L.; De Mattia, L.; Bongiorni, M. G.; Boriani, G.; Biffi, M.
abstract

Aim: To evaluate Attain Performa (Medtronic, Dublin, Ireland) quadripolar lead performance in clinical practice and, secondarily, to compare its long term clinical outcomes vs bipolar leads for left ventricular (LV) pacing. Methods and results: We retrospectively analyzed clinical, procedural and follow-up data of 215 patients implanted with a quadripolar lead. One hundred and twenty one patients implanted with bipolar lead were selected to compare long-term clinical outcomes. The quadripolar lead was implanted in the target vein in 196 patients (91%) without acute dislodgements. In 50% of patients the chosen final pacing configuration at implant would not have been available with bipolar leads. A dedicated quadripolar pacing vector was chosen more frequently when the LV tip location was apical than otherwise (65.6% vs 42.7%, p = 0.003). After a median follow-up of 14 months, the LV pacing threshold was less than 2.5 V at 0.4 ms in 98 patients (90%) with a safety margin between phrenic nerve and LV pacing threshold &gt;3 V in 97 patients (89%). We observed a slight trend toward a lower risk of heart failure worsening and a lower incidence of ventricular arrhythmias and pulmonary congestion in patients implanted with quadripolar leads compared with the control group. Conclusion: Quadripolar leads improve the management of phrenic nerve stimulation at no trade-off with pacing threshold and lead stability. Quadripolar leads seems to be associated with a lower incidence of VT/VF and pulmonary congestion, when compared with bipolar leads, but further investigations are necessary to confirm that this positive effect is associated with better LV reverse remodeling.

2018 - Physical activity measured by implanted devices predicts atrial arrhythmias and patient outcome: Results of IMPLANTED (Italian Multicentre Observational Registry on Patients With Implantable Devices Remotely Monitored) [Articolo su rivista]
Palmisano, Pietro; Guerra, Federico; Ammendola, Ernesto; Ziacchi, Matteo; Pisanó, Ennio Carmine Luigi; Dell'Era, Gabriele; Aspromonte, Vittorio; Zaccaria, Maria; Di Ubaldo, Francesco; Capucci, Alessandro; Nigro, Gerardo; Occhetta, Eraldo; Maglia, Giampiero; Ricci, Renato Pietro; Boriani, Giuseppe; Accogli, Michele; Botto, Gian Luca; Bertaglia, Emanuele; Berisso, Massimo Zoni; Nissardi, Vincenzo; Santini, Luca; Soldati, Ezio; Stabile, Giuseppe; Landolina, Maurizio; Padeletti, Luigi
abstract

Background--To determine whether daily physical activity (PA), as measured by implanted devices (through accelerometer sensor), was related to the risk of developing atrial arrhythmias during long-term follow-up in a population of heart failure (HF) patients with an implantable cardioverter defibrillator (ICD). Methods and Results--The study population was divided into 2 equally sized groups (PA cutoff point: 3.5 h/d) according to their mean daily PA recorded by the device during the 30- to 60-day period post-ICD implantation. Propensity score matching was used to compare 2 equally sized cohorts with similar characteristics between lower and higher activity patients. The primary end point was time free from the first atrial high-rate episode (AHRE) of duration ≥6 minutes. Secondary end points were: first AHRE ≥6 hours, first AHRE ≥48 hours, and a combined end point of death or HF hospitalization. Data from 770 patients (65±15 years; 66% men; left ventricular ejection fraction 35±12%) remotely monitored for a median of 25 months were analyzed. A PA =3.5 h/d was associated with a 38% relative reduction in the risk of AHRE ≥6 minutes (72-month cumulative survival: 75.0% versus 68.1%; log rank P=0.025), and with a reduction in the risk of AHRE ≥6 hours, AHRE ≥48 hours, and the combined end point of death or HF hospitalization (all P &lt; 0.05). Conclusions--In HF patients with ICD, a low level of daily PA was associated with a higher risk of atrial arrhythmias, regardless of the patients' baseline characteristics. In addition, a lower daily PA predicted death or HF hospitalization.

2018 - Practical management of ibrutinib in the real life: Focus on atrial fibrillation and bleeding [Articolo su rivista]
Boriani, Giuseppe; Corradini, Paolo; Cuneo, Antonio; Falanga, Anna; Foà, Robin; Gaidano, Gianluca; Ghia, Paolo Prospero; Martelli, Maurizio; Marasca, Roberto; Massaia, Massimo; Mauro, Francesca Romana; Minotti, Giorgio; Molica, Stefano; Montillo, Marco; Pinto, Antonio; Tedeschi, Alessandra; Vitolo, Umberto; Zinzani, Pier Luigi
abstract

The Bruton tyrosine kinase inhibitor ibrutinib (IB) has attained an important role in the treatment of patients with chronic lymphocytic leukaemia, mantle cell lymphoma, and Waldenström macroglobulinemia, significantly improving clinical outcomes. However, IB therapy has been associated with an increased risk of atrial fibrillation (AF) and bleeding. We report on the expert opinion that a group of Italian haematologists, cardiologists, and pharmacologists jointly released to improve the practical management of patients at risk for AF and bleeding during treatment with IB. A proper pretreatment assessment to identify patients who are at a higher risk, careful choice of concomitant drugs, regular monitoring, and multispecialist approach were characterized as the main principles of clinical management of these patients. For patients developing AF, anticoagulant and antiarrhythmic therapy must be guided by considerations about efficacy, safety, and risk of pharmacokinetic interactions with IB. For patients experiencing bleeding or requiring procedures that increase the risk of bleeding, considerations about platelet turnover, IB-related platelet dysfunctions, and bleeding worsening by concomitant anticoagulants or antiplatelet agents provide clues to manage bleeding. Overall, AF and bleeding are manageable clinical events in patients receiving IB, not requiring drug interruption in most cases. Preexisting AF should not represent an absolute contraindication to IB therapy. For each patient candidate for IB, strategies of risk assessment and mitigation may allow to exploit the life-saving effects of in chronic lymphocytic leukaemia and mantle cell lymphoma.

2018 - Predictors of long-term survival free from relapses after extraction of infected CIED [Articolo su rivista]
Diemberger, Igor; Biffi, Mauro; Lorenzetti, Stefano; Martignani, Cristian; Raffaelli, Elena; Ziacchi, Matteo; Rapezzi, Claudio; Pacini, Davide; Boriani, Giuseppe
abstract

Aims We explored the possible predictors of long-term prognosis after transvenous lead extraction (TLE) for a cardiac implantable device related infection (CIEDI), including the modified Duke score result. Methods and results We performed a single centre prospective observational study in a population of consecutive patients referred for TLE to a teaching hospital to treat a CIEDI without associated valve-endocarditis. 121 patients were enrolled between January 2012 and March 2016. According to the modified Duke criteria, the presence of CIED-related endocarditis was rejected in 54.5%, possible in 21.5%, and definite in 24.0%. 20/121 patients died after a mean follow-up of 46.0 ± 2.5 months, while 7 patients reported hospitalization for CIEDI recurrence/relapse in the same period. Modified Duke score was significantly associated with a poor prognosis at univariate Cox regression analysis (HR 1.847, 95% CI 1.160-2.941; P = 0.010). However, the three factors independently associated with death and/or CIEDI relapse/recurrence were: a 'closed' CIED pocket (HR 2.720; 95% CI 1.135-6.520), presence of ghost at post-TLE transoesophageal echocardiography (HR 3.469; 95% CI 1.420-8.878), and a GFR &lt;60 (HR 4.565; 95% CI 1.668-12.493). Conclusion CIEDI has a poor long-term prognosis despite an effective TLE. Renal failure, presence of 'ghosts' at post-TLE transoesophageal echocardiography and a closed CIED pocket are associated with a worse prognosis.

2018 - Rate vs. rhythm control and adverse outcomes among European patients with atrial fibrillation [Articolo su rivista]
Purmah, Yanish; Proietti, Marco; Laroche, Cecilé; Mazurek, Michal; Tahmatzidis, Dimitrios; Boriani, Giuseppe; Novo, Salvatore; Lip, Gregory Y. H.
abstract

The impact of rate and rhythm control strategies on outcomes in patients with atrial fibrillation (AF) remains controversial. Our aims were: to report use of rate and rhythm control strategies in European patients from the EURObservational Research Program AF General Pilot Registry. Secondly, to evaluate outcomes according to assigned strategies.

2018 - Registro Italiano Pacemaker e Defibrillatori: Bollettino Periodico 2016 Associazione Italiana di Aritmologia e Cardiostimolazione [Articolo su rivista]
Proclemer, Alessandro; Zecchin, Massimo; D'Onofrio, Antonio; Boriani, Giuseppe; Facchin, Domenico; Rebellato, Luca; Ghidina, Marco; Bianco, Giulia; Bernardelli, Emanuela; Pucher, Elsa; Gregori, Dario
abstract

Background: The pacemaker (PM) and implantable cardioverter-defibrillator (ICD) registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) monitors the main epidemiological data in real-world practice. The survey for the 2016 activity collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers. Methods: The registry collects prospectively national PM and ICD implantation activity on the basis of European cards. Results: PM Registry: data about 23 496 PM implantations were collected (19 003 first implant and 4493 replacements). The number of collaborating centers was 204. Median age of treated patients was 81 years (75 quartile I; 86 quartile III). ECG indications included atrioventricular conduction disorders in 39.8% of first PM implants, sick sinus syndrome in 22.1%, atrial fibrillation plus bradycardia in 14.1%, other in 24.0%. Among atrioventricular conduction defects, third-degree atrioventricular block was the most common type (22.18% of first implants). Use of single-chamber PMs was reported in 26.9% of first implants, of dual-chamber PMs in 65.0%, of PMs with cardiac resynchronization therapy (CRT) in 1.5%, and of single lead atrial-synchronized ventricular stimulation (VDD/R PMs) in 6.6%. ICD Registry: data about 20 350 ICD implantations were collected (14 763 first implants and 5587 replacements). The number of collaborating centers was 430. Median age of treated patients was 72 years (63 quartile I; 78 quartile III]. Primary prevention indication was reported in 79.0% of first implants, secondary prevention in 21.0% (cardiac arrest in 7.9%). A single-chamber ICD was used in 32.2% of first implants, dual-chamber in 31.1% and biventricular in 36.7%. Conclusions: The PM and ICD Registry appears fundamental for monitoring PM and ICD utilization on a large national scale with rigorous examination of demographics and clinical indications. The PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The use of CRT-PM regards a very limited number of patients. The ICD Registry documented a large use of prophylactic and biventricular ICD, reflecting a favorable adherence to trials and guidelines in clinical practice.

2018 - Risk stratification of cardiovascular and heart failure hospitalizations using integrated device diagnostics in patients with a cardiac resynchronization therapy defibrillator [Articolo su rivista]
Burri, Haran; Da Costa, Antoine; Quesada, Aurelio; Ricci, Renato Pietro; Favale, Stefano; Clementy, Nicolas; Boscolo, Gabriele; Villalobos, Federico Segura; Di Mangoni Stefano, Lorenza; Sharma, Vinod; Boriani, Giuseppe
abstract

Aims: Cardiac resynchronization therapy defibrillators (CRT-D) are able to monitor various parameters that may be combined by an automatic algorithm to provide a heart failure risk status (HFRS). We sought to validate the HFRS for stratifying patient risk, evaluate its association with heart failure (HF) symptoms, and investigate its utility for triage of automatic alerts. Methods and results: Data from 722 patients included in the MORE-CARE trial were analysed in a post hoc analysis. A high HFRS was associated with a significantly increased risk of admission over the next 30 days with a relative risk for cardiovascular hospitalization (CVH) of 4.5 (95% CI: 3.1-6.6, P &lt; 0.001), of HF hospitalization of 6.3 (95% CI: 3.9-10.2, P &lt; 0.001) and of non-HF related CVH of 3.5 (95% CI: 2.0-6.9, P &lt; 0.001). The negative predictive value of low or medium HFRS for these admissions was ≥98%. A high HFRS was associated with an increased risk of HF symptoms. Of all the automatic remote monitoring alerts generated during the study, only 10% had a high HFRS. Conclusion: The HFRS is able to risk-stratify CRT-D patients, which is potentially useful for managing automatic remote monitoring alerts, by focusing attention on the minority of high-risk patients.

2018 - Role of cardiovascular imaging in cardiac resynchronization therapy: A literature review [Articolo su rivista]
Sassone, Biagio; Nucifora, Gaetano; Mele, Donato; Valzania, Cinzia; Bisignani, Giovanni; Boriani, Giuseppe
abstract

Cardiac resynchronization therapy (CRT) is an established treatment in patients with symptomatic drug-refractory heart failure and broad QRS complex on the surface ECG. Despite the presence of either mechanical dyssynchrony or viable myocardium at the site where delivering left ventricular pacing being necessary conditions for a successfulCRT, their direct assessment by techniques of cardiovascular imaging, though feasible, is not recommended in clinical practice by the current guidelines. Indeed, even though there is growing body of data providing evidence of the additional value of an image-based approach as compared with routine approach in improving response to CRT, these results should be confirmed in prospective and large multicentre trials before their impact on CRT guidelines is considered.

2018 - Role of the tricuspid regurgitation after mitraclip and transcatheter aortic valve implantation: a systematic review and meta-analysis [Articolo su rivista]
Pavasini, Rita; Ruggerini, Sara; Grapsa, Julia; Biscaglia, Simone; Tumscitz, Carlo; Serenelli, Matteo; Boriani, Giuseppe; Squeri, Angelo; Campo, Gianluca
abstract

Treatment of tricuspid regurgitation (TR) is common after surgery for mitral and/or aortic valves. The prognostic role of moderate to severe TR in patients undergoing mitraclip or transcatheter aortic valve implantation (TAVI) is not well-defined. Thus, the aim of this article is to perform a systematic review and meta-analysis of articles valuing the prognostic role of TR for patients undergoing mitraclip and TAVI.

2018 - The 2018 European Heart Rhythm Association Practical Guide on the use of non-Vitamin K antagonist oral anticoagulants in patients with atrial fibrillation [Articolo su rivista]
Steffel, Jan; Verhamme, Peter; Potpara, Tatjana S.; Albaladejo, Pierre; Antz, Matthias; Desteghe, Lien; Haeusler, Karl Georg; Oldgren, Jonas; Reinecke, Holger; Roldan-Schilling, Vanessa; Rowell, Nigel; Sinnaeve, Peter; Collins, Ronan; Camm, A John; Heidbüchel, Hein; Boriani, Giuseppe
abstract

The current manuscript is the second update of the original Practical Guide, published in 2013 [Heidbuchel et al. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013;15:625-651; Heidbuchel et al. Updated European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation. Europace 2015;17:1467-1507]. Non-vitamin K antagonist oral anticoagulants (NOACs) are an alternative for vitamin K antagonists (VKAs) to prevent stroke in patients with atrial fibrillation (AF) and have emerged as the preferred choice, particularly in patients newly started on anticoagulation. Both physicians and patients are becoming more accustomed to the use of these drugs in clinical practice. However, many unresolved questions on how to optimally use these agents in specific clinical situations remain. The European Heart Rhythm Association (EHRA) set out to coordinate a unified way of informing physicians on the use of the different NOACs. A writing group identified 20 topics of concrete clinical scenarios for which practical answers were formulated, based on available evidence. The 20 topics are as follows i.e., (1) Eligibility for NOACs; (2) Practical start-up and follow-up scheme for patients on NOACs; (3) Ensuring adherence to prescribed oral anticoagulant intake; (4) Switching between anticoagulant regimens; (5) Pharmacokinetics and drug-drug interactions of NOACs; (6) NOACs in patients with chronic kidney or advanced liver disease; (7) How to measure the anticoagulant effect of NOACs; (8) NOAC plasma level measurement: rare indications, precautions, and potential pitfalls; (9) How to deal with dosing errors; (10) What to do if there is a (suspected) overdose without bleeding, or a clotting test is indicating a potential risk of bleeding; (11) Management of bleeding under NOAC therapy; (12) Patients undergoing a planned invasive procedure, surgery or ablation; (13) Patients requiring an urgent surgical intervention; (14) Patients with AF and coronary artery disease; (15) Avoiding confusion with NOAC dosing across indications; (16) Cardioversion in a NOAC-treated patient; (17) AF patients presenting with acute stroke while on NOACs; (18) NOACs in special situations; (19) Anticoagulation in AF patients with a malignancy; and (20) Optimizing dose adjustments of VKA. Additional information and downloads of the text and anticoagulation cards in different languages can be found on an EHRA website (www.NOACforAF.eu).

2018 - The 2018 European Heart Rhythm Association Practical Guide on the use of non-Vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: Executive summary [Articolo su rivista]
Steffel, Jan; Verhamme, Peter; Potpara, Tatjana S.; Albaladejo, Pierre; Antz, Matthias; Desteghe, Lien; Haeusler, Karl Georg; Oldgren, Jonas; Reinecke, Holger; Roldan-Schilling, Vanessa; Rowell, Nigel; Sinnaeve, Peter; Collins, Ronan; Camm, A. John; Heidbüchel, Hein; Boriani, Giuseppe
abstract

The current manuscript is the Executive Summary of the second update to the original Practical Guide, published in 2013. Non-vitamin K antagonist oral anticoagulants (NOACs) are an alternative for vitamin K antagonists (VKAs) to prevent stroke in patients with atrial fibrillation (AF), and have emerged as the preferred choice, particularly in patients newly started on anticoagulation. Both physicians and patients are becoming more accustomed to the use of these drugs in clinical practice. However, many unresolved questions on how to optimally use these agents in specific clinical situations remain. The European Heart Rhythm Association (EHRA) set out to co-ordinate a unified way of informing physicians on the use of the different NOACs. A writing group identified 20 topics of concrete clinical scenarios for which practical answers were formulated, based on available evidence. The 20 topics are (i) eligibility for NOACs; (ii) practical start-up and follow-up scheme for patients on NOACs; (iii) ensuring adherence to prescribed oral anticoagulant intake; (iv) switching between anticoagulant regimens; (v) pharmacokinetics and drug-drug interactions of NOACs; (vi) NOACs in patients with chronic kidney or advanced liver disease; (vii) how to measure the anticoagulant effect of NOACs; (viii) NOAC plasma level measurement: rare indications, precautions, and potential pitfalls; (ix) how to deal with dosing errors; (x) what to do if there is a (suspected) overdose without bleeding, or a clotting test is indicating a potential risk of bleeding; (xi) management of bleeding under NOAC therapy; (xii) patients undergoing a planned invasive procedure, surgery or ablation; (xiii) patients requiring an urgent surgical intervention; (xiv) patients with AF and coronary artery disease; (xv) avoiding confusion with NOAC dosing across indications; (xvi) cardioversion in a NOAC-treated patient; (xvii) AF patients presenting with acute stroke while on NOACs; (xviii) NOACs in special situations; (xix) anticoagulation in AF patients with a malignancy; and (xx) optimizing dose adjustments of VKA. Additional information and downloads of the text and anticoagulation cards in different languages can be found on an EHRA web site (www.NOACforAF.eu).

2018 - The struggle against infections of cardiac implantable electrical devices: the burden of costs requires new personalized solutions [Articolo su rivista]
Boriani, Giuseppe; Elsner, Christian; Diemberger, Igor
abstract

NA

2018 - The subtle connection between development of cardiac implantable electrical device infection and survival after complete system removal: An observational prospective multicenter study [Articolo su rivista]
Diemberger, Igor; Migliore, Federico; Biffi, Mauro; Cipriani, Alberto; Bertaglia, Emanuele; Lorenzetti, Stefano; Massaro, Giulia; Tanzarella, Gaia; Boriani, Giuseppe
abstract

Background Despite the improvements in transvenous lead extraction (TLE), patients with cardiac implantable device related infection (CIEDI) have a poor prognosis at long term. We explored the possible role of factors associated with development of CIEDI as predictors of post-TLE survival. Methods We performed a multi-center prospective observational study in a population of consecutive patients referred for TLE for CIEDI. We adopted a previously developed 10-point scale for CIEDI risk stratification and assessed its performance in predicting post-TLE survival. Results We enrolled 169 consecutive patients with CIEDI (systemic infection in 48.5% and vegetations in 24.5%). A Shariff score ≥ 3 was present in 102/169 (60.4%) of the enrolled patients. Complete radiological success of TLE was obtained in 163 patients. Twenty-seven patients (15.9%) died after a mean follow-up of 20.8 ± 12.0 months. Two factors were independently associated with post-TLE death: a Shariff score ≥ 3 (HR 10.833, 95% CI 2.544–46.129; p = 0.001) and the presence of vegetations at transesophageal echocardiography (HR 3.324, 95% CI 1.530–7.221; p = 0.002). Conclusions Risk factors for development of CIEDI are also predictive of post TLE mortality, together with the presence of vegetations. Improvement of our preventive strategies for CIEDI is crucial for enhancing the outcomes of CIED patients overall.

2018 - Use of idarucizumab in reversing dabigatran anticoagulant effect: a critical appraisal [Articolo su rivista]
Proietti, Marco; Boriani, Giuseppe
abstract

Use of non-vitamin K antagonist oral anticoagulants is spreading in the real world. Despite that, a strong need for antidotes/reversal agents is still reported by several physicians. Idarucizumab is a humanized monoclonal antibody fragment that binds specifically to dabigatran. Idarucizumab was approved in 2015 by the US Food and Drugs Administration and European Medicines Agency for reversal of anticoagulation activity in dabigatrantreated patients. This review briefly summarizes the experimental evidence about effectiveness and safety of idarucizumab. Furthermore, we review the current recommendations and experts' point of view about the use of antidotes/reversal agents in patients reporting a major bleeding event.

2018 - Variations in clinical management of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation according to different equations for estimating renal function: Post hoc analysis of a prospective cohort [Articolo su rivista]
Malavasi, Vincenzo Livio; Pettorelli, Daniele; Fantecchi, Elisa; Zoccali, Cristina; Laronga, Giuliana; Trenti, Tommaso; Lip, Gregory Yoke Hong; Boriani, Giuseppe
abstract

Prescription of non-vitamin K antagonist oral anticoagulants (NOACs) requires an assessment of renal function (RF) and the Cockcroft–Gault (CG) equation is traditionally recommended. The objective of the study was to evaluate the potential changes in NOACs management using different equations for estimating RF. In a post hoc analysis of a prospective cohort of patients with atrial fibrillation, we considered different equations: (1) CG for creatinine clearance (CrCl), (2) modification of diet in renal disease (MDRD), (3) CKD-EPI, (4) Berlin Initiative Study 1 (BIS-1) and (5) full age spectrum (FAS), for glomerular filtration rate (GFR). RF was classified according to CrCl in three categories: severely depressed (SD-RF) &lt; 30&nbsp;ml/min; moderately depressed (MD-RF) 30–49&nbsp;ml/min; preserved/mildly depressed (P-RF) ≥ 50&nbsp;ml/min. Concordances in the assignments were analyzed. A population of 402 patients (61.2% males, age 72 ± 11) was categorized according to CrCl: 12 patients (2.9%) as SD-RF, 81 (20.1%) as MD-RF, 309 (76.8%) as P-RF. A potential change in NOACs management could occur using GFR equations rather than CrCl in 16.9% of patients using MDRD formula, in 11.7% using BIS-1, in 14.7% using CKD-EPI and in 12.9% using the FAS equation. Important changes in RF estimates were more frequent in patients aged ≥ 75, but also BMI had a meaningful impact. Use of equations estimating GFR instead of the Cockcroft–Gault equation may result in changes in NOACs management in 12–17% of patients. In the elderly ≥ 75, more pronounced changes in RF classification are detectable according to different equations and NOACs dosing should be further investigated.

2018 - [Appropriateness criteria for the management of anticoagulant therapy in complex patients with atrial fibrillation. The opinion of a group of expert Italian cardiologists] [Articolo su rivista]
Botto, Giovanni Luca; Padeletti, Luigi; Ammirati, Fabrizio; Calò, Leonardo; Calvi, Valeria; Cappato, Riccardo; Capucci, Alessandro; D'Onofrio, Antonio; Grimaldi, Massimo; Lombardi, Federico; Lunati, Maurizio; Senatore, Gaetano; Themistoclackis, Sakis; Boriani, Giuseppe
abstract

Atrial fibrillation (AF) is a common arrhythmia often associated with high thromboembolic risk. The purpose of this position paper is to provide clinicians with recommendations useful in managing some important issues regarding the use of anticoagulant therapy in patients with AF in particularly complex clinical situations.The RAND/UCLA appropriateness method, validated to combine the best available scientific evidence with the collective judgment of experts, was used to assess the judgment of an expert panel of cardiologists. To this purpose, the benefit-to-harm ratio of 37 clinical scenarios was rated. Each indication was classified as "appropriate", "uncertain", or "inappropriate" in accordance with the panelists' median score.The present document reports the results of this consensus process, which led to the development of recommendations for clinical practice on how to use anticoagulant therapy in patients with AF in complex clinical settings, including the presence of comorbidities, cardioversion, or ablation. Non-vitamin K oral anticoagulants are a valid alternative to vitamin K antagonists in preventing embolic events in patients with non-valvular AF, particularly in case of clinical complexity.

2017 - 'Real-world' atrial fibrillation management in Europe: observations from the 2-year follow-up of the EURObservational Research Programme-Atrial Fibrillation General Registry Pilot Phase [Articolo su rivista]
Proietti, Marco; Laroche, Cécile; Opolski, Grzegorz; Maggioni, Aldo P; Boriani, Giuseppe; Lip, Gregory Y. H.
abstract

Atrial fibrillation (AF) is commonly associated with a high risk of stroke, thromboembolism, and mortality. The 1-year follow-up of the EURObservational Research Programme-Atrial Fibrillation (EORP-AF) Pilot Registry demonstrated a high mortality but good outcomes with European Society of Cardiology guideline-adherent therapy. Whether these 'real-world' observations on patients managed by European cardiologists extend to 2 years remains uncertain.

2017 - A first described case of cancer-associated non-bacterial thrombotic endocarditis in the era of direct oral anticoagulants [Articolo su rivista]
Mantovani, F.; Navazio, A.; Barbieri, A.; Boriani, Giuseppe
abstract

N/A

2017 - Adoption Decisions for Medical Devices in the Field of Cardiology: Results from a European Survey [Articolo su rivista]
Hatz, Maximilian H. M; Schreyögg, Jonas; Torbica, Aleksandra; Boriani, Giuseppe; Blankart, Carl R. B.
abstract

Decisions to adopt medical devices at the hospital level have consequences for health technology assessment (HTA) on system level and are therefore important to decision makers. Our aim was to investigate the characteristics of organizations and individuals that are more inclined to adopt and utilize cardiovascular devices based on a comprehensive analysis of environmental, organizational, individual, and technological factors and to identify corresponding implications for HTA. Seven random intercept hurdle models were estimated using the data obtained from 1249 surveys completed by members of the European Society of Cardiology. The major findings were that better manufacturer support increased the adoption probability of ‘new’ devices (i.e. in terms of CE mark approval dates), and that budget pressure increased the adoption probability of ‘old’ devices. Based on our findings, we suggest investigating the role of manufacturer support in more detail to identify diffusion patterns relevant to HTA on system level, to verify whether it functions as a substitute for medical evidence of new devices, and to receive new insights about its relationship with clinical effectiveness and cost-effectiveness. © 2017 The Authors. Health Economics published by John Wiley &amp; Sons, Ltd.

2017 - Adverse outcomes in patients with atrial fibrillation and peripheral arterial disease: a report from the EURObservational research programme pilot survey on atrial fibrillation [Articolo su rivista]
Proietti, Marco; Raparelli, Valeria; Laroche, Cécile; Dan, Georghe Andrei; Janion, Marianna; Popescu, Raluca; Sinagra, Gianfranco; Vijgen, Johan; Boriani, Giuseppe; Maggioni, Aldo P; Tavazzi, Luigi; Lip, Gregory Y. H.
abstract

Peripheral arterial disease (PAD) is highly prevalent in general population. Data on the prevalence of symptomatic PAD in patients with atrial fibrillation (AF) are limited, and the impact of PAD on adverse outcomes in AF patients is controversial. Our aims were: (i) to define the prevalence of symptomatic PAD in European AF patients and describe its associated clinical risk factors and (ii) to establish the relationship of PAD to adverse events in AF, especially all-cause death.

2017 - Antithrombotic Therapy in Atrial Fibrillation Associated with Valvular Heart Disease: Executive Summary of a Joint Consensus Document from the European Heart Rhythm Association (EHRA) and European Society of Cardiology Working Group on Thrombosis, Endorsed by the ESC Working Group on Valvular Heart Disease, Cardiac Arrhythmia Society of Southern Africa (CASSA), Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), South African Heart (SA Heart) Association and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE) [Articolo su rivista]
Lip, Gregory Y. H.; Collet, Jean Philippe; De Caterina, Raffaele; Fauchier, Laurent; Lane, Deirdre A.; Larsen, Torben B.; Marin, Francisco; Morais, Joao; Narasimhan, Calambur; Olshansky, Brian; Pierard, Luc; Potpara, Tatjana; Sarrafzadegan, Nizal; Sliwa, Karen; Varela, Gonzalo; Vilahur, Gemma; Weiss, Thomas; Boriani, Giuseppe; Rocca, Bianca
abstract

Management strategies for patients with atrial fibrillation (AF) in association with valvular heart disease (VHD) have been less informed by randomized trials, which have largely focused on 'non-valvular AF' patients. Thromboembolic risk also varies according to valve lesion and may also be associated with CHA 2 DS 2 -VASc score risk factor components, rather than only the valve disease being causal. Given the need to provide expert recommendations for professionals participating in the care of patients presenting with AF and associated VHD, a task force was convened by the European Heart Rhythm Association (EHRA) and European Society of Cardiology (ESC) Working Group (WG) on Thrombosis, with representation from the ESC WG on Valvular Heart Disease, Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), South African Heart (SA Heart) Association and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE) with the remit to comprehensively review the published evidence, and to produce a consensus document on the management of patients with AF and associated VHD, with up-to-date consensus statements for clinical practice for different forms of VHD, based on the principles of evidence-based medicine. This is an executive summary of a consensus document which proposes that the term 'valvular AF' is outdated and given that any definition ultimately relates to the evaluated practical use of oral anticoagulation (OAC) type, we propose a functional EHRA (Evaluated Heartvalves, Rheumatic or Artificial) categorization in relation to the type of OAC use in patients with AF, as follows: (1) EHRA (Evaluated Heartvalves, Rheumatic or Artificial) type 1 VHD, which refers to AF patients with 'VHD needing therapy with a vitamin K antagonist (VKA)' and (2) EHRA (Evaluated Heartvalves, Rheumatic or Artificial) type 2 VHD, which refers to AF patients with 'VHD needing therapy with a VKA or a non-VKA oral anticoagulant also taking into consideration CHA 2 DS 2 -VASc score risk factor components.

2017 - Antithrombotic therapy in atrial fibrillation associated with valvular heart disease: A joint consensus document from the European Heart Rhythm Association (EHRA) and European Society of Cardiology Working Group on Thrombosis, endorsed by the ESC Working Group on Valvular Heart Disease, Cardiac Arrhythmia Society of Southern Africa (CASSA), Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), South African Heart (SA Heart) Association and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE) [Articolo su rivista]
Lip, Gregory Y. H; Collet, Jean Philippe; Caterina, Raffaele De; Fauchier, Laurent; Lane, Deirdre A; Larsen, Torben B; Marin, Francisco; Morais, Joao; Narasimhan, Calambur; Olshansky, Brian; Pierard, Luc; Potpara, Tatjana; Sarrafzadegan, Nizal; Sliwa, Karen; Varela, Gonzalo; Vilahur, Gemma; Weiss, Thomas; Boriani, Giuseppe; Rocca, Bianca; Gorenek, Bulent; Savelieva, Irina; Sticherling, Christian; Kudaiberdieva, Gulmira; Chao, Tze-Fan; Violi, Francesco; Nair, Mohan; Zimerman, Leandro; Piccini, Jonathan; Storey, Robert; Halvorsen, Sigrun; Gorog, Diana; Rubboli, Andrea; Chin, Ashley; Scott-Millar, Robert
abstract

Atrial fibrillation (AF) is a major public health problem1 with global prevalence rates (per 1000000 population) in 2010 being 596.2 (95% uncertainty interval (UI), 558.4-636.7) in men and 373.1 (95% UI, 347.9-402.2) in women; the incidence rates increased to 77.5 (95% UI, 65.2-95.4) in men and 59.5 (95% UI, 49.9-74.9) in women.2 Worldwide, AF in association with valvular heart disease (VHD) is also common, and management strategies for this group of patients have been less addressed by randomized trials. The latter have largely focused on 'non-valvular AF' patients leading to major uncertainties over how to define (and treat) such patients. There is also an important heterogeneity in the definition of valvular and non-valvular AF.3 Some physicians assume that any valve disease should be considered as 'valvular' AF. Others consider that only mechanical valve prosthesis and rheumatic mitral stenosis should be defined as 'valvular' AF. The term valvular AF has been arbitrarily applied and the 2016 ESC guidelines have avoided the term 'valvular AF' and refer simply to 'AF related to hemodynamically significant mitral stenosis or prosthetic mechanical heart valves'.4 AF clearly leads to an incremental risk for thromboembolism in patients with mitral valve stenosis, but there are limited data for other valvular diseases. Another proposal is to use the acronym MARM-AF as a simple acronym to designate 'Mechanical and Rheumatic Mitral AF' as an alternative to term 'valvular AF' to designate the clinical scenarios for which at the non-vitamin K antagonist oral anticoagulants (NOACs) are not indicated.5 For this document we recognize the uncertainty in terminology, and our scope largely relates to AF related to 'hemodynamically significant' rheumatic VHD (ie. severe enough to impact on patient's survival or necessitates an intervention or surgery) or prosthetic mechanical heart valves. Nonetheless, thrombo-embolic (TE) risk varies according to valve lesion and may be associated with CHA2DS2VASc score risk factor components, rather than the valve disease per se being causal.6,7 TE risk may also be influenced not only by type but also the severity of the lesion. For example, the degree of mitral regurgitation may matter when it comes to risk of TE as some studies suggest that mild (Grade 1) mitral regurgitation is associated with a 2.7-fold increased risk of stroke/TE, while severe forms may possibly have a 'protective' effect (HR = 0.45 for stroke and 0.27 for LA stasis.8 An appropriate definition of 'valvular AF' would need to identify a subgroup of patients with similar pathophysiology of thrombo-embolism, TE risk, and treatment strategies6,9; however, this would be challenging given the major heterogeneity of the condition. This consensus document proposes that the term 'valvular AF' is outdated and given that any definition ultimately relates to the evaluated practical use of oral anticoagulation (OAC) type, we propose a functional EHRA (EvaluatedHeartvalves, Rheumatic orArtificial) categorization in relation to the type of OAC use in patients with AF, as follows:Evaluated Heartvalves, Rheumatic or Artificial (EHRA) Type 1,which refers to AF patients with 'VHD needing therapy with a Vitamin K antagonist (VKA)'

2017 - Arrhythmias Originating in the Atria [Articolo su rivista]
Leonelli, Fabio; Bagliani, Giuseppe; Boriani, Giuseppe; Padeletti, Luigi
abstract

Atrial flutter, atrial tachycardias, and atrial fibrillation are the main sustained atrial tachycardias. Reentry, increased automaticity, and triggered activity are atrial arrhythmia's main mechanisms. Atrial flutter is the clinical and theoretical model of reentry. Its classification is based on the atrial chamber involved and the arrhythmia's anatomic path. Ablative procedures for atrial fibrillation have created several new reentrant tachycardias. Electrocardiography (ECG) identifies the site of origin of focal atrial tachycardias and the mechanism of these arrhythmias. ECG is fundamental in the diagnosis of atrial fibrillation and often allows understanding of its mechanism of origin and maintenance.

2017 - Atrial antitachycardia pacing and atrial remodeling: A substudy of the international, randomized MINERVA trial [Articolo su rivista]
Boriani, Giuseppe; Tukkie, Raymond; Biffi, Mauro; Mont, Lluis; Ricci, Renato; Pürerfellner, Helmut; Botto, Giovanni Luca; Manolis, Antonis S; Landolina, Maurizio; Gulizia, Michele; Hudnall, J. Harrison; Mangoni, Lorenza; Grammatico, Andrea; Padeletti, Luigi
abstract

Atrial tachycardia (AT) and atrial fibrillation (AF) are common in pacemaker patients and are associated with bad prognoses.

2017 - Can we predict new AF occurrence in single-chamber ICD patients? Insights from an observational investigation [Articolo su rivista]
Biffi, Mauro; Ziacchi, Matteo; Ricci, Renato Pietro; Facchin, Domenico; Morani, Giovanni; Landolina, Maurizio; Lunati, Maurizio; Iacopino, Saverio; Capucci, Alessandro; Bianchi, Stefano; Infusino, Tommaso; Botto, Giovanni Luca; Padeletti, Luigi; Boriani, Giuseppe
abstract

Background Atrial tachyarrhythmias (AT/AF) have been associated with an increased risk of mortality, morbidity and ischemic stroke. Up to now, single chamber ICD diagnostics was not able to detect AT/AF, therefore the incidence of new onset AT/AF in patients with single chamber ICD is not known. Objective To evaluate incidence and predictors of AT/AF occurrence in patients with dual-chamber ICD with no pacing indications and no history of AT/AF that strictly mimic single chamber ICD recipient. Methods &amp; results Consecutive dual-chamber ICD patients were prospectively followed by 47 Italian cardiologic centers in an observational research. Clinical and device data were reviewed by expert cardiologists to assess AT/AF occurrence. Multivariate regression analysis evaluated the risk of new-onset AT/AF and its association with patients’ baseline characteristics and with CHADS2 score. 428 (13.4% female, 64&nbsp;years old) patients were followed for a median observation period of 31&nbsp;months. AT/AF episodes occurred in 160 (37.4%) patients when considering at least 5&nbsp;min duration, in 95 (22.2%) for AT/AF ≥&nbsp;6&nbsp;h, in 47 (11.0%) for AT/AF ≥&nbsp;1&nbsp;day, in 29 (6.8%) for AT/AF ≥&nbsp;7&nbsp;days. Patients with CHADS2&nbsp;≥&nbsp;2, who comprised 36% of the whole population, showed higher incidence of AT/AF ≥&nbsp;6&nbsp;h compared with patients with CHADS2&nbsp;&lt;&nbsp;2 (Hazard Ratio&nbsp;=&nbsp;1.69, 95% Confidence Interval&nbsp;=&nbsp;1.13–2.53, p&nbsp;=&nbsp;0.011). Conclusions Our observations in a population of dual-chamber ICD patients with no pacing indications and no history of AT/AF, who strictly mimic single–chamber ICD recipients, highlight that AT/AF episodes occurred in the 37.5% of the population and CHADS2 score is predictive of new-onset AT/AF.

2017 - Cardiac Resynchronization Therapy: An Overview on Guidelines [Articolo su rivista]
Boriani, Giuseppe; Nesti, Martina; Ziacchi, Matteo; Padeletti, Luigi
abstract

Cardiac resynchronization therapy (CRT) is included in international consensus guidelines as a treatment with proven efficacy in well-selected patients on top of optimal medical therapy. Although all the guidelines strongly recommend CRT for LBBB with QRS duration greater than 150&nbsp;milliseconds, lower strength of recommendation is reported for QRS duration of 120&nbsp;to 150&nbsp;milliseconds, especially if not associated with LBBB. CRT is not recommended for a QRS of less than 120&nbsp;milliseconds. No indication emerges for guiding the implant based on echocardiographic evaluation of dyssynchrony. Many data indicate that CRT is underused and there is heterogeneity in its implementation.

2017 - Cardiac resynchronization therapy in the real world: need to focus on implant rates, patient selection, co-morbidities, type of devices, and complications [Articolo su rivista]
Boriani, Giuseppe; Diemberger, Igor
abstract

N/A

2017 - Clinically guided pacemaker choice and setting: pacemaker expert programming study [Articolo su rivista]
Ziacchi, Matteo; Palmisano, Pietro; Ammendola, Ernesto; Dell'Era, Gabriele; Guerra, Federico; Aquilani, Stefano; Aspromonte, Vittorio; Boriani, Giuseppe; Accogli, Michele; Del Giorno, Giuseppe; Occhetta, Eraldo; Capucci, Alessandro; Ricci, Renato Pietro; Maglia, Giampiero; Biffi, Mauro
abstract

The aim of this multicentre, observational, transversal study was to evaluate pacemaker (PM) choice and setting in a large number of patients, in order to understand their relationship with the patients' clinical characteristics.

2017 - Corrigendum: Glomerular filtration rate in patients with atrial fibrillation and 1-year outcomes (Scientific Reports (2016) 6 (30271) DOI: 10.1038/srep30271) [Articolo su rivista]
Boriani, Giuseppe; Laroche, Cécile; Diemberger, Igor; Popescu, Mircea Ioachim; Rasmussen, Lars Hvilsted; Petrescu, Lucian; Crijns, Harry J. G. M; Tavazzi, Luigi; Maggioni, Aldo P; Lip, Gregory Y. H.
abstract

This Article contains errors in the Acknowledgements section: "Abbott Vascular Int. (2011-2014), Amgen (2012-2018), AstraZeneca (2014-2017), Bayer (2013-2018), Boehringer Ingelheim (2013-2016), Boston Scientific (2010-2012), The Bristol Myers Squibb and Pfizer Alliance (2014-2016), The Alliance Daiichi Sankyo Europe GmbH and Eli Lilly and Company (2014-2017), Gedeon Richter Plc. (2014-2017), Menarini Int. Op. (2010-2012), MSD-Merck &amp; Co. (2011-2014), Novartis Pharma AG (2014-2017), ResMed (2014-2016), Sanofi (2010-2011), SERVIER (2012-2018)". should read: "Abbott Vascular Int. (2011-2014), Amgen (2009-2018), AstraZeneca (2014-2017), Bayer (2009-2018), Boehringer Ingelheim (2009-2016), Boston Scientific (2009-2012), The Bristol Myers Squibb and Pfizer Alliance (2011-2016), The Alliance Daiichi Sankyo Europe GmbH and Eli Lilly and Company (2011-2017), Gedeon Richter Plc. (2014-2017), Menarini Int. Op. (2009-2012), MSD-Merck &amp; Co. (2011-2014), Novartis Pharma AG (2014-2017), ResMed (2014-2016), Sanofi (2009-2011), SERVIER (2009-2018)".

2017 - Device-detected subclinical atrial tachyarrhythmias: Definition, implications and management - An European Heart Rhythm Association (EHRA) consensus document, endorsed by Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS) and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE) [Articolo su rivista]
Gorenek, Bulent; Bax, Jeroen; Boriani, Giuseppe; Chen, Shih-Ann; Dagres, Nikolaos; Glotzer, Taya V.; Healey, Jeff S.; Israel, Carsten W.; Kudaiberdieva, Gulmira; Levin, Lars-Åke; Lip, Gregory Y. H.; Martin, David; Okumura, Ken; Svendsen, Jesper H.; Tse, Hung-Fat; Botto, Giovanni L.; Linde, Cecilia; Kutyifa, Valentina; Bernat, Robert; Scherr, Daniel; Lau, Chu-Pak; Iturralde, Pedro; Morin, Daniel P.; Savelieva, Irina
abstract

Among atrial tachyarrhythmias (AT), atrial fibrillation (AF) is the most common sustained arrhythmia. Many patients with AT have no symptoms during brief or even extended periods of the arrhythmia, making detection in patients at risk for stroke challenging. Subclinical atrial tachyarrhythmia and asymptomatic or silent atrial tachyarrhythmia often precede the development of clinical AF. Clinical AF and subclinical atrial fibrillation (SCAF) are associated with an increased risk of thromboembolism. Indeed, in many cases, SCAF is discovered only after complications such as ischaemic stroke or congestive heart failure have occurred.

2017 - Edoxaban in Atrial Fibrillation and Venous Thromboembolism—Ten Key Questions and Answers: A Practical Guide [Articolo su rivista]
De Caterina, Raffaele; Ageno, Walter; Boriani, Giuseppe; Colonna, Paolo; Ghirarduzzi, Angelo; Patti, Giuseppe; Rossini, Roberta; Rubboli, Andrea; Schinco, Piercarla; Agnelli, Giancarlo
abstract

Edoxaban is the fourth non-vitamin K antagonist oral anticoagulant now available for clinical use in the prevention of stroke/systemic embolism in atrial fibrillation (AF) and in the treatment of venous thromboembolism (VTE), after the completion of large-scale randomized comparative clinical trials with the vitamin K antagonist warfarin. Edoxaban has some peculiar pharmacological properties and outcome data. Here a group of experts in AF and VTE answers a set of questions on its practical use, trying to define the profile of patients that would be most appropriate for its use.

2017 - Effect of fixed-rate vs. Rate-RESPONSIve pacing on exercise capacity in patients with permanent, refractory atrial fibrillation and left ventricular dysfunction treated with atrioventricular junction aBLation and bivEntricular pacing (RESPONSIBLE): A prospective, multicentre, randomized, single-blind study [Articolo su rivista]
Palmisano, Pietro; Aspromonte, Vittorio; Ammendola, Ernesto; Dell'Era, Gabriele; Ziacchi, Matteo; Guerra, Federico; Aquilani, Stefano; Maglia, Giampiero; Del Giorno, Giuseppe; Giubertoni, Ailia; Boriani, Giuseppe; Capucci, Alessandro; Ricci, Renato Pietro; Accogli, Michele
abstract

Aims: Atrioventricular junction (AVJ) ablation followed by biventricular pacing is an established strategy for improving symptoms and morbidity in patients with permanent atrial fibrillation (AF), reduced left ventricular ejection fraction (LVEF), and uncontrolled ventricular rate. There is no clear evidence that such patients benefit from rate-responsive (RR) pacing. Methods and results: This prospective, randomized, single-blind, multicentre study was designed as an intra-patient comparison and enrolled 60 patients (age 69.5 ± 11.8 years, males 63.3%, NYHA 3.0 ±0.6) with refractory AF and reduced LVEF (mean 32.4±8.3%) treated with AVJ ablation and biventricular pacing. Two 6-minute walking tests (6MWT) were performed 1 week apart: one during VVI 70/min biventricular pacing and the other during VVIR 70-130/min biventricular pacing; patients were randomly and blindly assigned to Group A (n = 29, first 6MWT in VVIR mode) or B (n = 31, first 6MWT in VVI mode). Rate-responsive activation determined an increase of 18.8±24.4 m in the distance walked during the 6MWT (P &lt; 0.001). The increase was similar in both groups (P = 0.571). A &gt;5% increase in the distance walked was observed in 76.7% of patients. The increase in the distance walked was linearly correlated with the increase in heart rate recorded during the 6MWT in the VVIR mode (r = 0.54; P &lt; 0.001). Conclusion: In permanent AF patients with uncontrolled rate and reduced LVEF who had undergone AVJ ablation and biventricular pacing, RR pacing yields a significant gain in exercise capacity, which seems to be related to the RR-induced frequency during effort.

2017 - Effects of remote monitoring on clinical outcomes and use of healthcare resources in heart failure patients with biventricular defibrillators: results of the MORE-CARE multicentre randomized controlled trial [Articolo su rivista]
Boriani, Giuseppe; Da Costa, Antoine; Quesada, Aurelio; Ricci, Renato Pietro; Favale, Stefano; Boscolo, Gabriele; Clementy, Nicolas; Amori, Valentina; Lorenza, Mangoni di S. Stefano; Burri, Haran
abstract

Aims: The aim of this study was to evaluate the clinical efficacy and safety of remote monitoring in patients with heart failure implanted with a biventricular defibrillator (CRT-D) with advanced diagnostics. Methods and results: The MORE-CARE trial is an international, prospective, multicentre, randomized controlled trial. Within 8 weeks of de novo implant of a CRT-D, patients were randomized to undergo remote checks alternating with in-office follow-ups (Remote arm) or in-office follow-ups alone (Standard arm). The primary endpoint was a composite of death and cardiovascular (CV) and device-related hospitalization. Use of healthcare resources was also evaluated. A total of 865 eligible patients (mean age 66 ± 10 years) were included in the final analysis (437 in the Remote arm and 428 in the Standard arm) and followed for a median of 24 (interquartile range = 15–26) months. No significant difference was found in the primary endpoint between the Remote and Standard arms [hazard ratio 1.02, 95% confidence interval (CI) 0.80–1.30, P = 0.89] or in the individual components of the primary endpoint (P &gt; 0.05). For the composite endpoint of healthcare resource utilization (i.e. 2-year rates of CV hospitalizations, CV emergency department admissions, and CV in-office follow-ups), a significant 38% reduction was found in the Remote vs. Standard arm (incidence rate ratio 0.62, 95% CI 0.58–0.66, P &lt; 0.001) mainly driven by a reduction of in-office visits. Conclusions: In heart failure patients implanted with a CRT-D, remote monitoring did not reduce mortality or risk of CV or device-related hospitalization. Use of healthcare resources was significantly reduced as a result of a marked reduction of in-office visits without compromising patient safety. Trial registration: NCT00885677.

2017 - Electrical treatment of atrial arrhythmias in heart failure patients implanted with a dual defibrillator CRT device. Results from the TRADE-HF study [Articolo su rivista]
Botto, Giovanni Luca; Padeletti, Luigi; Covino, Gregorio; Pieragnoli, Paolo; Liccardo, Mattia; Mariconti, Barbara; Favale, Stefano; Molon, Giulio; De Filippo, Paolo; Bolognese, Leonardo; Landolina, Maurizio; Raciti, Giovanni; Boriani, Giuseppe
abstract

Background Ventricular and atrial arrhythmias commonly occur in heart failure patients and are a significant source of symptoms, morbidity and mortality. Some specific generators referred to as dual defibrillators, Dual CRT-Ds, have the ability to treat atrial and ventricular arrhythmias. TRADE-HF is a prospective two-arm randomized study aimed at assessing the benefits of complete automatic management of atrial arrhythmias in patients implanted with a dual CRT-D. Methods Primary objective of the TRADE-HF study was to document reduction of unplanned hospital admission for cardiac reasons or death for cardiovascular causes or progression to permanent AF, by comparing fully-automatic device driven therapy for atrial tachycardia or fibrillation (AT/AF) to an in-hospital approach for treatment of symptomatic AT/AF. Randomized Patients were followed every 6&nbsp;months for 3&nbsp;years to assess the primary objective. Results Four-hundred-twenty patients have been enrolled in the study. At the end of the study 30 subjects died for cardiovascular causes, 60 had at least one hospitalization for cardiovascular causes and 14 developed permanent AF. Eighty-seven patients experienced a composite event. Hazard Ratio for device-managed automatic therapy arm compared to traditional was 0.987 (95% CI: 0.684–1.503; p&nbsp;=&nbsp;0.951). The primary endpoint analysis resulted in no difference between the device managed and in-hospital treatment arm. Conclusion The TRADE-HF study failed to demonstrate a reduction in the composite of unplanned hospitalizations for cardiovascular causes or death for cardiovascular causes or progression to permanent AF using automatic atrial therapy compared to a traditional approach including hospitalization for symptomatic episodes and/or in-hospital treatment of AT/AF.

2017 - Electrocardiogram Alterations Associated With Psychotropic Drug Use and CACNA1C Gene Variants in Three Independent Samples [Articolo su rivista]
Fabbri, Chiara; Boriani, Giuseppe; Diemberger, Igor; Filippi, Maria Giulia; Ravegnini, Gloria; Hrelia, Patrizia; Minarini, Alessandro; Albani, Diego; Forloni, Gianluigi; Angelini, Sabrina; Serretti, Alessandro
abstract

Several antipsychotics and antidepressants have been associated with QTc prolongation or other electrocardiogram (ECG) alterations, but their impact is still debated and other risk factors are known to affect QTc. We investigated the effect of antidepressants and antipsychotics on QTc and other ECG intervals/waves in three samples. Two discovery samples (cross-sectional sample n = 145 and prospective sample n = 68, naturalistic treatment) and a replication prospective sample (Clinical Antipsychotic Trials of Intervention Effectiveness, n = 515, randomized treatment) were analysed. In both prospective samples, baseline/follow-up changes in ECG parameters were analysed in relation to the number of psychotropic drugs stratified according to their known cardiovascular risk. In the cross-sectional sample, ECG parameters were compared among drugs with different risk profile. The possible effect of single nucleotide polymorphisms (SNPs) in the CACNA1C gene on QTc was also investigated. There was no evidence of mean QTc prolongation or increased risk of clinically relevant QTc prolongation (≥20 msec.) in association with psychotropic drugs stratified according to their known cardiovascular risk. The prescription of drugs with cardiovascular risk was less common in older individuals or individuals with cardiovascular comorbidities. Other factors (gender, baseline QTc, renal function) affected QTc. rs1006737 and SNPs in linkage disequilibrium with it modulated QTc duration/changes in all samples. An association between risk drugs and shorter RR interval or higher heart rate was found in all samples. A relevant effect of psychotropic drugs with cardiovascular risk on QTc duration was not observed. A number of factors other than psychotropic drugs may influence QTc. CACNA1C rs1006737 may modulate QTc in patients treated with psychotropic drugs.

2017 - Emery-Dreifuss Muscular Dystrophy-Associated Mutant Forms of Lamin A Recruit the Stress Responsive Protein Ankrd2 into the Nucleus, Affecting the Cellular Response to Oxidative Stress [Articolo su rivista]
Angori, Silvia; Capanni, Cristina; Faulkner, Georgine; Bean, Camilla; Boriani, Giuseppe; Lattanzi, Giovanna; Cenni, Vittoria
abstract

Background: Ankrd2 is a stress responsive protein mainly expressed in muscle cells. Upon the application of oxidative stress, Ankrd2 translocates into the nucleus where it regulates the activity of genes involved in cellular response to stress. Emery-Dreifuss Muscular Dystrophy 2 (EDMD2) is a muscular disorder caused by mutations of the gene encoding lamin A, LMNA. As well as many phenotypic abnormalities, EDMD2 muscle cells also feature a permanent basal stress state, the underlying molecular mechanisms of which are currently unclear. Methods: Experiments were performed in EDMD2-lamin A overexpressing cell lines and EDMD2-affected human myotubes. Oxidative stress was produced by H2O2 treatment. Co-immunoprecipitation, cellular subfractionation and immunofluorescence analysis were used to validate the relation between Ankrd2 and forms of lamin A; cellular sensibility to stress was monitored by the analysis of Reactive Oxygen Species (ROS) release and cell viability. Results: Our data demonstrate that oxidative stress induces the formation of a complex between Ankrd2 and lamin A. However, EDMD2-lamin A mutants were able to bind and mislocalize Ankrd2 in the nucleus even under basal conditions. Nonetheless, cells co-expressing Ankrd2 and EDMD2-lamin A mutants were more sensitive to oxidative stress than the Ankrd2-wild type lamin A counterpart. Conclusions: For the first time, we present evidence that in muscle fibers from patients affected by EDMD2, Ankrd2 has an unusual nuclear localization. By introducing a plausible mechanism ruling this accumulation, our data hint at a novel function of Ankrd2 in the pathogenesis of EDMD2-affected cells.

2017 - European Heart Rhythm Association (EHRA)/European Association of Cardiovascular Prevention and Rehabilitation (EACPR) position paper on how to prevent atrial fibrillation endorsed by the Heart Rhythm Society (HRS) and Asia Pacific Heart Rhythm Society (APHRS) [Articolo su rivista]
Gorenek, Bulent; Pelliccia, Antonio; Benjamin, Emelia J.; Boriani, Giuseppe; Crijns, Harry J.; Fogel, Richard I.; Van Gelder, Isabelle C.; Halle, Martin; Kudaiberdieva, Gulmira; Lane, Deirdre A.; Bjerregaard Larsen, Torben; Lip, Gregory Y. H.; Løchen, Maja Lisa; Marin, Francisco; Niebauer, Josef; Sanders, Prashanthan; Tokgozoglu, Lale; Vos, Marc A.; Van Wagoner, David R.; Fauchier, Laurent; Savelieva, Irina; Goette, Andreas; Agewall, Stefan; Chiang, Chern En; Figueiredo, Márcio; Stiles, Martin; Dickfeld, Timm; Patton, Kristen; Piepoli, Massimo; Corra, Ugo; Manuel Marques Vidal, Pedro; Faggiano, Pompilio; Schmid, Jean Paul; Abreu, Ana
abstract

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2017 - European Heart Rhythm Association (EHRA)/European Association of Cardiovascular Prevention and Rehabilitation (EACPR) position paper on how to prevent atrial fibrillation endorsed by the Heart Rhythm Society (HRS) and Asia Pacific Heart Rhythm Society (APHRS) [Articolo su rivista]
Gorenek, Bulent; Pelliccia, Antonio; Benjamin, Emelia J.; Boriani, Giuseppe; Crijns, Harry J.; Fogel, Richard I.; Van Gelder, Isabelle C.; Halle, Martin; Kudaiberdieva, Gulmira; Lane, Deirdre A.; Larsen, Torben Bjerregaard; Lip, Gregory Y. H.; Løchen, Maja Lisa; Marín, Francisco; Niebauer, Josef; Sanders, Prashanthan; Tokgozoglu, Lale; Vos, Marc A.; Vanwagoner, David R.; Fauchier, Laurent; Savelieva, Irina; Goette, Andreas; Agewall, Stefan; Chiang, Chern En; Figueiredo, Marcio; Stiles, Martin; Dickfeld, Timm; Patton, Kristen; Piepoli, Massimo; Corra, Ugo; Marques Vidal, Pedro Manuel; Faggiano, Pompilio; Schmid, Jean Paul; Abreu, Ana
abstract

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2017 - European heart rhythm association (EHRA) consensus document on the management of supraventricular arrhythmias, endorsed by Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulación Cardiaca y Electrofisiologia (SOLAECE) [Articolo su rivista]
Katritsis, Demosthenes G.; Boriani, Giuseppe; Cosio, Francisco G.; Hindricks, Gerhard; Jäis, Pierre; Josephson, Mark E.; Keegan, Roberto; Kim, Young Hoon; Knight, Bradley P.; Kuck, Karl Heinz; Lane, Deirdre A.; Lip, Gregory Y. H.; Malmborg, Helena; Oral, Hakan; Pappone, Carlo; Themistoclakis, Sakis; Wood, Kathryn A.; Blomström Lundqvist, Carina; Gorenek, Bulent; Dagres, Nikolaos; Dan, Gheorge Andrei; Vos, Marc A.; Kudaiberdieva, Gulmira; Crijns, Harry; Roberts Thomson, Kurt; Lin, Yenn Jiang; Vanegas, Diego; Caorsi, Walter Reyes; Cronin, Edmond; Rickard, Jack
abstract

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2017 - Evaluating adherence to non-vitamin-K antagonist oral anticoagulants in post-approval observational studies of patients with atrial fibrillation [Articolo su rivista]
Potpara, Tatjana S.; Boriani, Giuseppe; Lip, Gregory Y. H.
abstract

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2017 - How to RESPOND to the quest to increase the effectiveness of cardiac resynchronization therapy? [Articolo su rivista]
Boriani, Giuseppe
abstract

This editorial refers to 'Contractility sensor-guided optimization of cardiac resynchronization therapy: results from the RESPOND-CRT trial', by J. Brugada et al., on page 730.

2017 - Hypertension and cardiac arrhythmias: A consensus document from the European Heart Rhythm Association (EHRA) and ESC Council on Hypertension, endorsed by the Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS) and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE) [Articolo su rivista]
Lip, Gregory Y. H.; Coca, Antonio; Kahan, Thomas; Boriani, Giuseppe; Manolis, Antonis S.; Olsen, Michael Hecht; Oto, Ali; Potpara, Tatjana S.; Steffel, Jan; Marín, Francisco; De Oliveira Figueiredo, Márcio Jansen; De Simone, Giovanni; Tzou, Wendy S.; Chiang, Chern-En; Williams, Bryan; Dan, Gheorghe-Andrei; Gorenek, Bulent; Fauchier, Laurent; Savelieva, Irina; Hatala, Robert; Van Gelder, Isabelle; Brguljan-Hitij, Jana; Erdine, Serap; Lovic, Dragan; Kim, Young-Hoon; Salinas-Arce, Jorge; Field, Michael
abstract

Hypertension is a common cardiovascular risk factor leading to heart failure (HF), coronary artery disease, stroke, peripheral artery disease and chronic renal insufficiency. Hypertensive heart disease can manifest as many cardiac arrhythmias, most commonly being atrial fibrillation (AF). Both supraventricular and ventricular arrhythmias may occur in hypertensive patients, especially in those with left ventricular hypertrophy (LVH) or HF. Also, some of the antihypertensive drugs commonly used to reduce blood pressure, such as thiazide diuretics, may result in electrolyte abnormalities (e.g. hypokalaemia, hypomagnesemia), further contributing to arrhythmias, whereas effective control of blood pressure may prevent the development of the arrhythmias such as AF. In recognizing this close relationship between hypertension and arrhythmias, the European Heart Rhythm Association (EHRA) and the European Society of Cardiology (ESC) Council on Hypertension convened a Task Force, with representation from the Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE), with the remit to comprehensively review the available evidence to publish a joint consensus document on hypertension and cardiac arrhythmias, and to provide up-to-date consensus recommendations for use in clinical practice. The ultimate judgment regarding care of a particular patient must be made by the healthcare provider and the patient in light of all of the circumstances presented by that patient.

2017 - Hypertension and cardiac arrhythmias: executive summary of a consensus document from the European Heart Rhythm Association (EHRA) and ESC Council on Hypertension, endorsed by the Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE) [Articolo su rivista]
Lip, Gregory Y. H; Coca, Antonio; Kahan, Thomas; Boriani, Giuseppe; Manolis, Antonis S; Olsen, Michael Hecht; Oto, Ali; Potpara, Tatjana S; Steffel, Jan; Marín, Francisco; de Oliveira Figueiredo, Márcio Jansen; de Simone, Giovanni; Tzou, Wendy S; En Chiang, Chern; Williams, Bryan
abstract

Hypertension (HTN) is a common cardiovascular risk factor leading to heart failure (HF), coronary artery disease (CAD), stroke, peripheral artery disease and chronic renal failure. Hypertensive heart disease can manifest as many types of cardiac arrhythmias, most commonly being atrial fibrillation (AF). Both supraventricular and ventricular arrhythmias may occur in HTN patients, especially in those with left ventricular hypertrophy (LVH), CAD, or HF. In addition, high doses of thiazide diuretics commonly used to treat HTN, may result in electrolyte abnormalities (e.g. hypokalaemia, hypomagnesaemia), contributing further to arrhythmias, while effective blood pressure control may prevent the development of the arrhythmias such as AF. In recognizing this close relationship between HTN and arrhythmias, the European Heart Rhythm Association (EHRA) and the European Society of Cardiology (ESC) Council on Hypertension convened a Task Force, with representation from the Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE), with the remit of comprehensively reviewing the available evidence and publishing a joint consensus document on HTN and cardiac arrhythmias, and providing up-to-date consensus recommendations for use in clinical practice. The ultimate judgment on the care of a specific patient must be made by the healthcare provider and the patient in light of all individual factors presented. This is an executive summary of the full document co-published by EHRA in EP-Europace.

2017 - Investigating Regional Variation of Cardiac Implantable Electrical Device Implant Rates in European Healthcare Systems: What Drives Differences? [Articolo su rivista]
Torbica, Aleksandra; Banks, Helen; Valzania, Cinzia; Boriani, Giuseppe; Fattore, Giovanni
abstract

Despite established efficacy for cardiac implantable electrical devices (CIEDs), large differences in CIED implant rates have been documented across and within countries. The aim of this paper is to investigate the influence of socio-economic, epidemiological and supply side factors on CIED implant rates across 57 Regions in 5 EU countries and to assess the feasibility of using administrative data for this purpose. A total of 1&nbsp;330&nbsp;098 hospitalizations for CIED procedures extracted from hospital discharge databases in Austria, England, Germany, Italy and Slovenia from 2008 to 2012 was used in the analysis. Higher levels of tertiary education among the labour force and percent of aged population are positively associated with implant rates of CIED. Regional per capita GDP and number of implanting centres appear to have no significant effect. Institutional factors are shown to be important for the diffusion of CIED. Wide variation in CIED implant rates across and within five EU countries is undeniable. However, regional factors play a limited part in explaining these differences with few exceptions. Administrative databases are a valuable source of data for investigating the diffusion of medical technologies, while the choice of appropriate modelling strategy is crucial in identifying the drivers for variation across countries. © 2017 The Authors. Health Economics published by John Wiley &amp; Sons, Ltd.

2017 - Management of atrial high-rate episodes detected by cardiac implanted electronic devices [Articolo su rivista]
Freedman, Ben; Boriani, Giuseppe; Glotzer, Taya V.; Healey, Jeff S.; Kirchhof, Paulus; Potpara, Tatjana S.
abstract

Cardiac implanted electronic devices (CIEDs), including pacemakers and implantable defibrillators that perform atrial sensing typically using an atrial electrode, frequently detect subclinical atrial high-rate episodes (AHREs). When the intracardiac electrograms are carefully examined, the majority of AHREs are atrial fibrillation (AF) or other atrial tachyarrhythmias, which have been shown to be associated with both an increased risk of stroke, and subsequent development of clinical AF. However, the absolute risk of stroke among patients with AHREs is less than might be expected for clinically diagnosed paroxysmal AF. In addition, a close temporal relationship between AHREs and stroke is seen in only 15% of strokes in patients with a CIED: The majority have either no AHREs before the stroke, or AHREs very distant from incident stroke, suggesting that AHREs might be more of a risk marker than a risk factor for stroke. Management of AHREs should not be the same as for clinical AF, and a degree of uncertainty underpins the rationale for much-needed, ongoing, randomized trials of oral anticoagulation in patients with CIED-detected AHREs. We propose a management algorithm that takes into account both the stroke risk and the AHRE burden, but highlights the current uncertainty and evidence gaps for this condition.

2017 - Occupational radiation exposure in the electrophysiology laboratory with a focus on personnel with reproductive potential and during pregnancy: A European Heart Rhythm Association (EHRA) consensus document endorsed by the Heart Rhythm Society (HRS) [Articolo su rivista]
Sarkozy, Andrea; De Potter, Tom; Heidbuchel, Hein; Ernst, Sabine; Kosiuk, Jedrzej; Vano, Eliseo; Picano, Eugenio; Arbelo, Elena; Tedrow, Usha; Lip, Gregory YH; Potpara, Tatjana; Lundqvist, Carina Blomström; Mandrola, John; Lane, Deirdre A.; Dagres, Nikolaos; Chung, Mina K.; Wunderle, Kevin A.; Boriani, Giuseppe
abstract

N/A

2017 - Oral loading of propafenone: restoring its role before restoring rhythm [Articolo su rivista]
Martignani, Cristian; Diemberger, Igor; Ziacchi, Matteo; Biffi, Mauro; Boriani, Giuseppe
abstract

N/A

2017 - Outcomes with dronedarone in atrial fibrillation: What differences between real-world practice and trials? A meta-analysis and meta-regression analysis [Articolo su rivista]
Diemberger, Igor; Massaro, Giulia; Reggiani, Maria L. B.; Lorenzetti, Stefano; Biffi, Mauro; Ziacchi, Matteo; Martignani, Cristian; Boriani, Giuseppe
abstract

Dronedarone was found to have divergent safety profiles in randomized controlled trials (RCT) in term of cardiac death and overall mortality. We decided to evaluate all available evidence on the cardiovascular safety of this drug. A systematic search was made of the MEDLINE and the Cochrane Central Register of Controlled Trials from January 2003 through April 2016 for RCT comparing dronedarone to placebo/active control, to provide the most accurate estimate of the effects of this agent and observational cohort studies (OBS) reporting clinical outcomes in patients treated with dronedarone, according to current guidelines, to obtain a real-life comparator for the findings summarized by RTC analysis. The literature search yielded 2335 papers and after careful review we identified 12 RCT and 7 OBS studies. RCT meta-analysis showed that, despite high heterogeneity, dronedarone was not associated with increased all-cause mortality [OR (Odds Ratio) 1.36, 95%CI (Confidence Interval) 0.79-2.33; p=0.732, I2=57.0%] or cardiovascular mortality [OR 1.51 95%CI 0.74-3.08; p=0.860, I2=64.4%]. OBS studies had a trend toward a better survival with respect to RCT [ES (Effect Size) 2.03, 95%CI 0.53-3.53 vs. ES 3.03, 95%CI 1.23-4.83; p=0.115], reaching the significance when restricted to the cardiovascular mortality [ES 0.52, 95%CI 0.36-0.69 vs. ES 1.86, 95%CI 0.62-3.09; p<0.001]. Two variables, co-adiministration of digoxin and prevalence of non-permanent AF completely abolished the dishomogeneity among the analyzed RCT studies. In conclusion, use of dronedarone for prophylaxis of AF recurrences is not associated with an increased risk of death, either cardiovascular or total, and combination with digoxin should be avoided.

2017 - Pacemaker-detected severe sleep apnea predicts new-onset atrial fibrillation [Articolo su rivista]
Mazza, Andrea; Bendini, Maria Grazia; De Cristofaro, Raffaele; Lovecchio, Mariolina; Valsecchi, Sergio; Boriani, Giuseppe
abstract

Sleep apnea (SA) diagnosed on overnight polysomnography is a risk factor for atrial fibrillation (AF). Advanced pacemakers are now able to monitor intrathoracic impedance for automatic detection of SA events.

2017 - Patient outcome after implant of a cardioverter defibrillator in the ‘real world’: the key role of co-morbidities [Articolo su rivista]
Boriani, Giuseppe; Malavasi, Vincenzo Livio
abstract

This article refers to 'The impact of co-morbidity burden on appropriate implantable cardioverter defibrillator therapy and all-cause mortality: insight from Danish nationwide clinical registers,' by A.C. Ruwald et al., published in this issue on pages 377-386.

2017 - Pre-participation cardiovascular evaluation for athletic participants to prevent sudden death: Position paper from the EHRA and the EACPR, branches of the ESC. Endorsed by APHRS, HRS, and SOLAECE [Articolo su rivista]
Mont, Lluis; Pelliccia, Antonio; Sharma, Sanjay; Biffi, Alessandro; Borjesson, Mats; Terradellas, Josep Brugada; Carre, Francois; Guasch, Eduard; Heidbuchel, Hein; La Gerche, Andre; Lampert, Rachel; Mckenna, William; Papadakis, Michail; Priori, Silvia G.; Scanavacca, Mauricio; Thompson, Paul; Sticherling, Christian; Viskin, Sami; Wilson, Mathew; Corrado, Domenico; Gregory, Lip Y. H.; Gorenek, Bulent; Lundqvist, Carina Blomström; Merkely, Bela; Hindricks, Gerhard; Hernandez Madrid, Antonio; Lane, Deirdre; Boriani, Giuseppe; Narasimhan, Calambur; Marquez, Manlio F.; Haines, David; Mackall, Judith; Marques Vidal, Pedro Manuel; Corra, Ugo; Halle, Martin; Tiberi, Monica; Niebauer, Josef; Piepoli, Massimo
abstract

N/A

2017 - Pre-participation cardiovascular evaluation for athletic participants to prevent sudden death: Position paper from the EHRA and the EACPR, branches of the ESC. Endorsed by APHRS, HRS, and SOLAECE [Articolo su rivista]
Mont, Lluís; Pelliccia, Antonio; Sharma, Sanjay; Biffi, Alessandro; Borjesson, Mats; Brugada Terradellas, Josep; Carré, Francois; Guasch, Eduard; Heidbuchel, Hein; La Gerche, André; Lampert, Rachel; Mckenna, William; Papadakis, Michail; Priori, Silvia G; Scanavacca, Mauricio; Thompson, Paul; Sticherling, Christian; Viskin, Sami; Wilson, Mathew; Corrado, Domenico; Lip, Gregory Y. H.; Gorenek, Bulent; Blomström Lundqvist, Carina; Merkely, Bela; Hindricks, Gerhard; Hernández Madrid, Antonio; Lane, Deirdre; Boriani, Giuseppe; Narasimhan, Calambur; Marquez, Manlio F.; Haines, David; Mackall, Judith; Manuel Marques Vidal, Pedro; Corra, Ugo; Halle, Martin; Tiberi, Monica; Niebauer, Josef; Piepoli, Massimo
abstract

N/A

2017 - Prevalence and clinical significance of left bundle branch block according to classical or strict definition criteria in permanent pacemaker patients [Articolo su rivista]
Mazza, Andrea; Bendini, Maria Grazia; De Cristofaro, Raffaele; Lovecchio, Mariolina; Valsecchi, Sergio; Leggio, Massimo; Boriani, Giuseppe
abstract

Previous studies have shown that the presence of left bundle branch block (LBBB) is associated with an increased risk of cardiac mortality and heart failure (HF). Recently, new criteria to define strict LBBB have been proposed: QRS duration ≥140 ms for men and ≥130 ms for women, along with mid-QRS notching or slurring in ≥2 contiguous leads.

2017 - Rationale and design of the Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation (ARTESiA) trial [Articolo su rivista]
Lopes, Renato D; Alings, Marco; Connolly, Stuart J.; Beresh, Heather; Granger, Christopher B.; Mazuecos, Juan Benezet; Boriani, Giuseppe; Nielsen, Jens C.; Conen, David; Hohnloser, Stefan H.; Mairesse, Georges H.; Mabo, Philippe; Camm, A. John; Healey, Jeffrey S.
abstract

Background Device-detected subclinical atrial fibrillation (AF) refers to infrequent, short-lasting, asymptomatic AF that is detected only with long-term continuous monitoring. Subclinical AF is common and associated with an increased risk of stroke; however, the risk of stroke with subclinical AF is lower than for clinical AF, and very few patients with subclinical AF alone have been included in large AF anticoagulation trials. The net benefit of anticoagulation in patients with subclinical AF is unknown. Design ARTESiA is a prospective, multicenter, double-blind, randomized controlled trial, recruiting patients with subclinical AF detected by an implanted pacemaker, defibrillator, or cardiac monitor, and who have additional risk factors for stroke. Patients with clinical AF documented by surface electrocardiogram will be excluded from the study. Participants will be randomized to receive either apixaban (according to standard AF dosing) or aspirin 81&nbsp;mg daily. The primary outcome is the composite of stroke, transient ischemic attack with diffusion-weighted magnetic resonance imaging evidence of cerebral infarction, and systemic embolism. Approximately 4,000 patients will be enrolled from around 230 clinical sites, with an anticipated mean follow-up of 36&nbsp;months until 248 adjudicated primary outcome events have occurred. Summary ARTESiA will determine whether oral anticoagulation therapy with apixaban compared with aspirin reduces the risk of stroke or systemic embolism in patients with subclinical AF and additional risk factors.

2017 - Reduction in unnecessary ventricular pacing fails to affect hard clinical outcomes in patients with preserved left ventricular function: A meta-analysis [Articolo su rivista]
Shurrab, Mohammed; Healey, Jeff S.; Haj Yahia, Saleem; Kaoutskaia, Anna; Boriani, Giuseppe; Carrizo, Aldo; Botto, Gianluca; Newman, David; Padeletti, Luigi; Connolly, Stuart J.; Crystal, Eugene
abstract

Aims Several pacing modalities across multiple manufacturers have been introduced to minimize unnecessary right ventricular pacing.We conducted a meta-analysis to assess whether ventricular pacing reduction modalities (VPRM) influence hard clinical outcomes in comparison to standard dual-chamber pacing (DDD). Methods and results An electronic search was performed using Cochrane Central Register, PubMed, Embase, and Scopus. Only randomized controlled trials (RCT) were included in this analysis. Outcomes of interest included: frequency of ventricular pacing (VP), incident persistent/permanent atrial fibrillation (PerAF), all-cause hospitalization and all-cause mortality. Odds ratios (OR) were reported for dichotomous variables. Seven RCTs involving 4119 adult patients were identified. Ventricular pacing reduction modalities were employed in 2069 patients: (MVP, Medtronic Inc.) in 1423 and (SafeR, Sorin CRM, Clamart) in 646 patients. Baseline demographics and clinical characteristics were similar between VPRM and DDD groups. The mean follow-up period was 2.5+0.9 years. Ventricular pacing reduction modalities showed uniform reduction in VP in comparison to DDD groups among all individual studies. The incidence of PerAF was similar between both groups 8 vs. 10%, OR 0.84 [95% confidence interval (CI) 0.57; 1.24], P = 0.38. Ventricular pacing reductionmodalities showed no significant differences in comparison toDDDfor all-cause hospitalization or all-cause mortality [9 vs. 11%, OR 0.82 (95% CI 0.65; 1.03), P= 0.09; 6 vs. 6%, OR 0.97 (95% CI 0.74; 1.28), P = 0.84, respectively]. Conclusion Novel VPRM measures effectively reduce VP in comparison to standard DDD. When actively programmed, VPRM did not improve clinical outcomes and were not superior to standard DDD programming in reducing incidence of PerAF, all-cause hospitalization, or all-cause mortality.

2017 - Registro Italiano pacemaker e defibrillatori bollettino periodico 2015: Associazione Italiana di Aritmologia e Cardiostimolazione [Articolo su rivista]
Proclemer, Alessandro; Zecchin, Massimo; D'Onofrio, Antonio; Boriani, Giuseppe; Botto, Giovanni Luca; Facchin, Domenico; Rebellato, Luca; Ghidina, Marco; Bianco, Giulia; Bernardelli, Emanuela; Pucher, Elsa; Gregori, Dario
abstract

Background: The pacemaker (PM) and implantable cardioverter-defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) monitors the main epidemiological data in real-world practice. The survey for the 2015 activity collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the Italian collaborating centers. Methods: The Registry collects prospectively national PM and ICD implantation activity on the basis of European cards. Results: PM Registry: data about 24 285 PM implantations were collected (19 194 first implant and 5091 replacements). The number of collaborating centers was 218. Median age of treated patients was 81 years (75 quartile I; 86 quartile III). ECG indications included atrioventricular conduction disorders in 42.8% of first PM implants, sick sinus syndrome in 22.9%, atrial fibrillation plus bradycardia in 15.1%, other in 19.2%. Among atrioventricular conduction defects, third-degree atrioventricular block was the most common type (23.8% of first implants). Use of single-chamber PMs was reported in 26.9% of first implants, of dual-chamber PMs in 63.4%, of PMs with cardiac resynchronization therapy (CRT) in 1.8%, and of single lead atrial-synchronized ventricular stimulation (VDD/R PMs) in 7.9%. ICD Registry: data about 15 363 ICD implantations were collected (11 453 first implants and 3910 replacements). The number of collaborating centers was 434. Median age of treated patients was 71 years (63 quartile I; 78 quartile III]. Primary prevention indication was reported in 77.3% of first implants, secondary prevention in 22.7% (cardiac arrest in 8.0%). A single-chamber ICD was used in 29.3% of first implants, dual-chamber in 34.6% and biventricular in 36.1%. Conclusions: The PM and ICD Registry appears fundamental for monitoring PM and ICD utilization on a large national scale with rigorous examination of demographics and clinical indications. The PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The use of CRT-PM regards a very limited number of patients. The ICD Registry documented a large use of prophylactic and biventricular ICD, reflecting a favorable adherence to trials and guidelines in clinical practice.

2017 - Screening for atrial fibrillation: A European Heart Rhythm Association (EHRA) consensus document endorsed by the Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLAECE) [Articolo su rivista]
Mairesse, Georges H.; Moran, Patrick; Van Gelder, Isabelle C.; Elsner, Christian; Rosenqvist, Marten; Mant, Jonathan; Banerjee, Amitava; Gorenek, Bulent; Brachmann, Johannes; Varma, Niraj; Glotz De Lima, Gustavo; Kalman, Jonathan; Claes, Neree; Lobban, Trudie; Lane, Deirdre; Lip, Gregory Y. H.; Boriani, Giuseppe; Fauchier, Laurent; Jung, Werner; Savelieva, Irina; Freedman, Benedict; Chen, Shih Ann; Isa, Rodrigo; Turakhia, Mintu; Sapp, John Lewis
abstract

NA

2017 - Screening for atrial fibrillation: A Report of the AF-SCREEN International Collaboration [Articolo su rivista]
Ben, Freedman; John, Camm; Hugh, Calkins; Jeffrey, S. Healey; Mårten, Rosenqvist; Jiguang, Wang; Christine, M. Albert; Craig, S. Anderson; Sotiris, Antoniou; Emelia, J. Benjamin; Boriani, Giuseppe; Johannes, Brachmann; Axel, Brandes; Tze Fan, Chao; David, Conen; Johan, Engdahl; Laurent, Fauchier; David, A. Fitzmaurice; Leif, Friberg; Bernard, J. Gersh; David, J. Gladstone; Taya, V. Glotzer; Kylie, Gwynne; Graeme, J. Hankey; Joseph, Harbison; Graham, S. Hillis; Mellanie, T. Hills; Hooman, Kamel; Paulus, Kirchhof; Peter, R. Kowey; Derk, Krieger; Vivian, W. Y. Lee; Lars Åke, Levin; Gregory, Y. H. Lip; Trudie, Lobban; Nicole, Lowres; Georges, H. Mairesse; Carlos, Martinez; Lis, Neubeck; Jessica, Orchard; Jonathan, P. Piccini; Katrina, Poppe; Tatjana, S. Potpara; Helmut, Puererfellner; Michiel, Rienstra; Roopinder, K. Sandhu; Renate, B. Schnabel; Chung Wah, Siu; Steven, Steinhubl; Jesper, H. Svendsen; Emma, Svennberg; Sakis, Themistoclakis; Robert, G. Tieleman; Mintu, P. Turakhia; Arnljot, Tveit; Steven, B. Uittenbogaart; Isabelle, C. Van Gelder; Atul, Verma; Rolf, Wachter; Bryan, P. Yan
abstract

Approximately 10% of ischemic strokes are associated with atrial fibrillation (AF) first diagnosed at the time of stroke. Detecting asymptomatic AF would provide an opportunity to prevent these strokes by instituting appropriate anticoagulation. The AF-SCREEN international collaboration was formed in September 2015 to promote discussion and research about AF screening as a strategy to reduce stroke and death and to provide advocacy for implementation of country-specific AF screening programs. During 2016, 60 expert members of AF-SCREEN, including physicians, nurses, allied health professionals, health economists, and patient advocates, were invited to prepare sections of a draft document. In August 2016, 51 members met in Rome to discuss the draft document and consider the key points arising from it using a Delphi process. These key points emphasize that screen-detected AF found at a single timepoint or by intermittent ECG recordings over 2 weeks is not a benign condition and, with additional stroke factors, carries sufficient risk of stroke to justify consideration of anticoagulation. With regard to the methods of mass screening, handheld ECG devices have the advantage of providing a verifiable ECG trace that guidelines require for AF diagnosis and would therefore be preferred as screening tools. Certain patient groups, such as those with recent embolic stroke of uncertain source (ESUS), require more intensive monitoring for AF. Settings for screening include various venues in both the community and the clinic, but they must be linked to a pathway for appropriate diagnosis and management for screening to be effective. It is recognized that health resources vary widely between countries and health systems, so the setting for AF screening should be both country- and health system-specific. Based on current knowledge, this white paper provides a strong case for AF screening now while recognizing that large randomized outcomes studies would be helpful to strengthen the evidence base.

2017 - Self-reported physical activity and major adverse events in patients with atrial fibrillation: A report from the EURObservational Research Programme Pilot Survey on Atrial Fibrillation (EORP-AF) General Registry [Articolo su rivista]
Proietti, Marco; Boriani, Giuseppe; Laroche, Cécile; Diemberger, Igor; Popescu, Mircea I.; Rasmussen, Lars H.; Sinagra, Gianfranco; Dan, Gheorghe Andrei; Maggioni, Aldo P.; Tavazzi, Luigi; Lane, Deirdre A.; Lip, Gregory Y. H.
abstract

Aims Physical activity is protective against cardiovascular (CV) events, both in general population and in high-risk CV cohorts. However, the relationship between physical activity with major adverse outcomes in atrial fibrillation (AF) is not wellestablished. Our aim was to analyse this relationship in a 'real-world' AF population. Second, we investigated the influence of physical activity on arrhythmia progression. Methods and results We studied all patients enrolled in the EURObservational Research Programme on AF (EORP-AF) Pilot Survey. Physical activity was defined as 'none', 'occasional', 'regular', and 'intense', based on patient self-reporting. Data on physical activity were available for 2442 patients: 38.9% reported none, 34.7% occasional, 21.7% regular, and 4.7% intense physical activity. Prevalence of the principal CV risk factors progressively decreased from none to intense physical activity. Lower rates of CV death, all-cause death, and composite outcomes were found in AF patients who reported regular and intense physical activity (P &lt; 0.0001). Increasing physical activity was inversely associated with CV death/any thromboembolic event (TE)/bleeding in the whole cohort, irrespective of gender, paroxysmal AF, elderly age, or high stroke risk. Any level of physical activity intensity was significantly associated with lower risk of CV death/any TE/bleeding at 1-year follow-up. Physical activity was not significantly associated with arrhythmia progression. Conclusion Atrial fibrillation patients taking regular exercise were associated with a lower risk of all-cause death, even when we considered various subgroups, including gender, elderly age, symptomatic status, and stroke risk class. Efforts to increase physical activity among AF patients may improve outcomes in these patients.

2017 - The Changing Landscape for Stroke Prevention in AF: Findings From the GLORIA-AF Registry Phase 2 [Articolo su rivista]
Huisman, Menno V; Rothman, Kenneth J.; Paquette, Miney; Teutsch, Christine; Diener, Hans Christoph; Dubner, Sergio J.; Halperin, Jonathan L.; Ma, Chang Sheng; Zint, Kristina; Elsaesser, Amelie; Bartels, Dorothee B.; Lip, Gregory Y. H.; Abban, Dzifa; Abdul, Nasser; Abelson, Mark; Ackermann, Alan; Adams, Fran; Adams, Luthando; Adragão, Pedro; Ageno, Walter; Aggarwal, Rajesh; Agosti, Sergio; Marin, Javier Aguila; Aguilar, Francisco; Aguilar Linares, Julio Alberto; Aguinaga, Luis; Ahmad, Zia; Ainsworth, Paul; Al Ghalayini, Kamal; Al Ismail, Saad; Alasfar, Abdelfatah; Alawwa, Abdul; Al Dallow, Raed; Alderson, Lisa; Alexopoulos, Dimitrios; Ali, Abdullah; Ali, Malik; Aliyar, Pareed; Al Joundi, Tammam; Al Mahameed, Soufian; Almassi, Hossein; Almuti, Khalid; Al Obaidi, Mohamed; Alshehri, Mohamed; Altmann, Ute; Alves, Alvaro Rabelo; Al Zoebi, Ayham; Amara, Walid; Amelot, Mathieu; Amjadi, Nima; Ammirati, Fabrizio; Andrawis, Nabil; Angoulvant, Denis; Annoni, Giorgio; Ansalone, Gerardo; Antonescu, Sorin Alexandru; Ariani, Mehrdad; Arias, Juan Carlos; Armero, Sébastien; Arora, Rohit; Arora, Chander; Ashcraft, William; Aslam, M. Shakil; Astesiano, Alfredo; Audouin, Philippe; Augenbraun, Charles; Aydin, S.; Azar, Rabih; Azim, Abul; Aziz, Shahid; Backes, Luciano Marcelo; Baig, Mirza; Bains, Suchdeep; Bakbak, Asaad; Baker, Seth; Bakhtiar, Karim; Bala, Richard; Banayan, Jonathan; Bandh, Stellan; Bando, Shigenobu; Banerjee, Subhash; Bank, Alan; Barbarash, Olga; Barón, Gonzalo; Barr, Craig; Barrera, Carlos; Barton, John; Kes, Vanja Basic; Baula, Giovanni; Bayeh, Hamid; Bazargani, Nooshin; Behrens, Steffen; Bell, Alan; Benezet Mazuecos, Juan; Benhalima, Bouziane; Berdagué, Philippe; Berg van den, B. J.; Bergen van, P. F. M. M.; Berngard, Edvard; Bernstein, Richard; Berrospi, Percy; Berti, Sergio; Bertomeu, Vicente; Berz, Andrea; Bettencourt, Paulo; Betzu, Robert; Beyer Westendorf, Jan; Bhagwat, Ravi; Black, Toby; Blanco Ibaceta, Jorge Hugo; Bloom, Stephen; Blumberg, Edwin; Bo, Mario; Bockisch, Valerie; Bøhmer, Ellen; Bongiorni, Maria Grazia; Boriani, Giuseppe; Bosch, Ralph; Boswijk, D. J.; Bott, Jochen; Bottacchi, Edo; Kalan, Marica Bracic; Brandes, Axel; Bratland, Bjørn; Brautigam, Donald; Breton, Nicolas; Brouwers, P. J. A. M.; Browne, Kevin; Bruguera, Jordi; Brunehaut, Myriam; Brunschwig, Claude; Buathier, Hervé; Buhl, Aurélie; Bullinga, John; Butcher, Kenneth; Cabrera Honorio, Jose Walter; Caccavo, Alberto; Cadinot, Didier; Cai, Shanglang; Calvi, Valeria; Camm, John; Candeias, Rui; Capo, James; Capucci, Alessandro; Cardoso, Juliano Novaes; Duarte Vera, Yan Carlos; Carlson, Brian; Carvalho, Paula; Cary, Susanna; Casanova, Rene; Casu, Gavino; Cattan, Simon; Cavallini, Claudio; Cayla, Guillaume; Cha, Tae Joon; Cha, Kwang Soo; Chaaban, Said; Chae, Jei Keon; Challappa, Krishnan; Chand, Sunil; Chandrashekar, Harinath; Chang, Mark; Charbel, Paul; Chartier, Ludovic; Chatterjee, Kausik; Cheema, Aamir; Chen, Shih Ann; Chevallereau, Pierre; Chiang, Fu Tien; Chiarella, Francesco; Chih Chan, Lin; Cho, Yong Keun; Choi, Dong Ju; Chouinard, Guy; Danny, Null; Chow, Hoi Fan; Chrysos, Dimitrios; Chumakova, Galina; José Roberto Chuquiure Valenzuela, Eduardo Julián; Cieza Lara, Tomas; Nica, Violeta Cindea; Ciobotaru, Vlad; Cislowski, David; Citerne, Olivier; Claus, Matthias; Clay, Anthony; Clifford, Piers; Cohen, Serge; Cohen, Andrew; Colivicchi, Furio; Collins, Rónán; Compton, Steve; Connors, Sean; Conti, Alberto; Buenostro, Gabriel Contreras; Coodley, Gregg; Cooper, Martin; Corbett, Lynn; Corey, Oran; Coronel, Julián; Corrigan, John; Cotrina Pereyra, Rosa Ysabel; Cottin, Yves; Coutu, Benoit; Cracan, Aurel; Crean, Peter; Crenshaw, James; Crijns, H. J. G. M.; Crump, Charles; Cucher, Fred; Cudmore, David; Cui, Lianqun; Culp, John; Darius, Harald; Dary, Patrick; Dascotte, Olivier; Dauber, Ira; Davee, Thomas; Davies, Ruth; Davis, Gershan; Davy, Jean Marc; Dayer, Mark; De La Briolle, Axel; de Mora, Manuel; De Teresa, Ed
abstract

Background GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non–vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase&nbsp;1. Methods During phase 2, 15,641 consenting patients were enrolled (November 2011 to December 2014); 15,092 were eligible. This pre-specified cross-sectional analysis describes eligible patients’ baseline characteristics. Atrial fibrillation&nbsp;disease characteristics, medical outcomes, and concomitant diseases and medications were collected. Data were analyzed using descriptive statistics. Results Of the total patients, 45.5% were female; median age was 71 (interquartile range: 64, 78) years. Patients were from Europe (47.1%), North America (22.5%), Asia (20.3%), Latin America (6.0%), and the Middle East/Africa (4.0%). Most had high stroke risk (CHA2DS2-VASc [Congestive heart failure, Hypertension, Age&nbsp;≥75 years, Diabetes mellitus, previous Stroke, Vascular disease, Age 65 to 74 years, Sex category] score&nbsp;≥2; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc&nbsp;= 1). Overall, 79.9% received oral anticoagulants, of whom 47.6% received NOAC and 32.3% vitamin K antagonists (VKA); 12.1% received antiplatelet agents; 7.8% received no antithrombotic treatment. For comparison, the proportion of phase 1 patients (of N&nbsp;= 1,063 all eligible) prescribed VKA was 32.8%, acetylsalicylic acid 41.7%, and no therapy 20.2%. In Europe in phase 2, treatment with NOAC was more common than VKA (52.3% and 37.8%, respectively); 6.0% of patients received antiplatelet treatment; and 3.8% received no antithrombotic treatment. In North America, 52.1%, 26.2%, and 14.0% of patients received NOAC, VKA, and antiplatelet drugs, respectively; 7.5% received no antithrombotic treatment. NOAC use was less common in Asia (27.7%), where 27.5% of patients received VKA, 25.0% antiplatelet drugs, and 19.8% no antithrombotic treatment. Conclusions The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in&nbsp;Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in&nbsp;Asia&nbsp;and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701)

2017 - The Italian subcutaneous implantable cardioverter-defibrillator survey: S-ICD, why not? [Articolo su rivista]
Botto, Giovanni Luca; Forleo, Giovanni B; Capucci, Alessandro; Solimene, Francesco; Vado, Antonello; Bertero, Giovanni; Palmisano, Pietro; Pisanò, Ennio; Rapacciuolo, Antonio; Infusino, Tommaso; Vicentini, Alessandro; Viscusi, Miguel; Ferrari, Paola; Talarico, Antonello; Russo, Giovanni; Boriani, Giuseppe; Padeletti, Luigi; Lovecchio, Mariolina; Valsecchi, Sergio; D'Onofrio, Antonio
abstract

A recommendation for a subcutaneous-implantable cardioverter-defibrillator (S-ICD) has been added to recent European Society of Cardiology Guidelines. However, the S-ICD is not ideally suitable for patients who need pacing. The aim of this survey was to analyse the current practice of ICD implantation and to evaluate the actual suitability of S-ICD.

2017 - The cost of atrial fibrillation in Italy: a five-year analysis of healthcare expenditure in the general population. From the Italian Survey of Atrial Fibrillation Management (ISAF) study [Articolo su rivista]
Zoni Berisso, M; Landolina, M; Ermini, G; Parretti, D; Zingarini, G. L; Degli Esposti, L; Cricelli, C; Boriani, Giuseppe
abstract

Atrial fibrillation (AF) is a relevant item of expenditure for the National Healthcare systems. The aim of the study was to estimate the annual costs of AF in Italy.

2017 - The effects of gender on electrical therapies for the heart: physiology, epidemiology, and access to therapies: A report from the XII Congress of the Italian Association on Arrhythmology and Cardiostimulation (AIAC) [Articolo su rivista]
Boriani, Giuseppe; Lorenzetti, Stefano; Cerbai, Elisabetta; Oreto, Giuseppe; Bronzetti, Gabriele; Malavasi, Vincenzo Livio; Biffi, Alessandro; Padeletti, Luigi; Botto, Gianluca; Diemberger, Igor
abstract

The difference between men and women is clear even just by looking at an electrocardiogram: females present higher resting heart rate, a shorter QRS complex length and greater corrected QT interval. The development of these differences from pubertal age onward suggests that sexual hormones play a key role, although their effect is far from being completely understood. Different incidences between sexes have been reported for many arrhythmias, both ventricular and supraventricular, and also for sudden cardiac death. Moreover, arrhythmias are an important issue during pregnancy, both for diagnosis and treatment. Interestingly, cardiovascular structural and electrophysiological remodelling promoted by exercise training enhances this 'gender effect'. Despite all these relevant issues, we lack gender specific recommendations in the current guidelines for electrical therapies for heart rhythm disorders and heart failure. Even more, we continue to see that fewer women are included in clinical trials and are less referred than men for these treatments.

2017 - The effects of gender on electrical therapies for the heart: procedural considerations, results and complications: A report from the XII Congress of the Italian Association on Arrhythmology and Cardiostimulation (AIAC) [Articolo su rivista]
Diemberger, Igor; Marazzi, Raffaella; Casella, Michela; Vassanelli, Francesca; Galimberti, Paola; Luzi, Mario; Borrelli, Alessio; Soldati, Ezio; Golzio, Pier Giorgio; Fumagalli, Stefano; Francia, Pietro; Padeletti, Luigi; Botto, Gianluca; Boriani, Giuseppe
abstract

Use of cardiac implantable devices and catheter ablation is steadily increasing in Western countries following the positive results of clinical trials. Despite the advances in scientific knowledge, tools development, and techniques improvement we still have some grey area in the field of electrical therapies for the heart. In particular, several reports highlighted differences both in medical behaviour and procedural outcomes between female and male candidates. Women are referred later for catheter ablation of supraventricular arrhythmias, especially atrial fibrillation, leading to suboptimal results. On the opposite females present greater response to cardiac resynchronization, while the benefit of implantable defibrillator in primary prevention seems to be less pronounced. Differences on aetiology, clinical profile, and development of myocardial scarring are the more plausible causes. This review will discuss all these aspects together with gender-related differences in terms of acute/late complications. We will also provide useful hints on plausible mechanisms and practical procedural aspects.

2017 - The increased risk of stroke/transient ischemic attack in women with a cardiac implantable electronic device is not associated with a higher atrial fibrillation burden [Articolo su rivista]
Boriani, Giuseppe; Lip, Gregory Y. H; Ricci, Renato Pietro; Proclemer, Alessandro; Landolina, Maurizio; Lunati, Maurizio; Padeletti, Luigi; Zanotto, Gabriele; Molon, Giulio; Biffi, Mauro; Rordorf, Roberto; Quartieri, Fabio; Gasparini, Maurizio
abstract

To evaluate if the increased thromboembolic risk in female patients may be related to a higher burden of atrial fibrillation (AF).

2017 - The wearable cardioverter-defibrillator: Current technology and evolving indications [Articolo su rivista]
Reek, Sven; Burri, Haran; Roberts, Paul R.; Perings, Christian; Epstein, Andrew E.; Klein, Helmut U.; Lip, Gregory; Gorenek, Bulent; Sticherling, Christian; Fauchier, Laurent; Goette, Andreas; Jung, Werner; Vos, Marc A.; Brignole, Michele; Elsner, Christian; Dan, Gheorghe Andrei; Marin, Francisco; Boriani, Giuseppe; Lane, Deirdre; Lundqvist, Carina Blomstrom; Savelieva, Irina
abstract

The wearable cardioverter-defibrillator has been available for over a decade and now is frequently prescribed for patients deemed at high arrhythmic risk in whom the underlying pathology is potentially reversible or who are awaiting an implantable cardioverter-defibrillator. The use of the wearable cardioverter-defibrillator is included in the new 2015 ESC guidelines for the management of ventricular arrhythmias and prevention of sudden cardiac death. The present review provides insight into the current technology and an overview of this approach.

2017 - Updated European Heart Rhythm Association practical guide on the use of non-vitamin-K antagonist anticoagulants in patients with non-valvular atrial fibrillation: Executive summary [Articolo su rivista]
Heidbuchel, Hein; Verhamme, Peter; Alings, Marco; Antz, Matthias; Diener, Hans-Christoph; Hacke, Werner; Oldgren, Jonas; Sinnaeve, Peter; Camm, A. John; Kirchhof, Paulus; Ahmad, Azhar; Heinrich-Nols, Jutta; Hess, Susanne; Müller, Markus; Münzel, Felix; Schwertfeger, Markus; Van Eickels, Martin; Richard-Lordereau, Isabelle; Lip, Gregory; Chiang, Chern-En; Piccini, Jonathan; Potpara, Tatjana; Fauchier, Laurent; Lane, Deirdre; Avezum, Alvaro; Bjerregaard Larsen, Torben; Boriani, Giuseppe; Roldan-Schilling, Vanessa; Gorenek, Bulent
abstract

In 2013, the European Heart Rhythm Association (EHRA) published a Practical Guide on the use of non-VKA oral anticoagulants (NOACs) in patients with atrial fibrillation (AF) (Heidbuchel H, Verhamme P, Alings M, Antz M, Hacke W, Oldgren J, Sinnaeve P, Camm AJ, Kirchhof P, European Heart Rhythm A. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013;15:625-651; Heidbuchel H, Verhamme P, Alings M, Antz M, Hacke W, Oldgren J, Sinnaeve P, Camm AJ, Kirchhof P. EHRA practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation: executive summary. Eur Heart J 2013;34:2094-2106). The document received widespread interest, not only from cardiologists but also from neurologists, geriatricians, and general practitioners, as became evident from the distribution of &gt; 350 000 copies of its pocket version (the EHRA Key Message Booklet) world-wide. Since 2013, numerous new studies have appeared on different aspects of NOAC therapy in AF patients. Therefore, EHRA updated the Practical Guide, including new information but also providing balanced guiding in the many areas where prospective data are still lacking. The outline of the original guide that addressed 15 clinical scenarios has been preserved, but all chapters have been rewritten. Main changes in the Update comprise a discussion on the definition of 'non-valvular AF' and eligibility for NOAC therapy, inclusion of finalized information on the recently approved edoxaban, tailored dosing information dependent on concomitant drugs, and/or clinical characteristics, an expanded chapter on neurologic scenarios (ischaemic stroke or intracranial haemorrhage under NOAC), an updated anticoagulation card and more specifics on start-up and follow-up issues. There are also many new flow charts, like on appropriate switching between anticoagulants (VKA to NOAC or vice versa), default scenarios for acute management of coronary interventions, step-down schemes for longterm combined antiplatelet-anticoagulant management in coronary heart disease, management of bleeding, and cardioversion under NOAC therapy. The Updated Guide is available in full in EP Europace (Heidbuchel H, Verhamme P, Alings M, Antz M, Diener HC, HackeW, Oldgren J, Sinnaeve P, Camm AJ, Kirchhof P, Advisors. Updated European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation. Europace 2015;17:1467-1507), while additional resources can be found at the related ESC/EHRA website (www.NOACforAF.eu).

2017 - Use of antihistamines and risk of ventricular tachyarrhythmia: a nested case-control study in five European countries from the ARITMO project [Articolo su rivista]
Poluzzi, Elisabetta; Diemberger, I.; De Ridder, M.; Koci, A.; Clo, M.; Oteri, A.; Pecchioli, S.; Bezemer, I.; Schink, T.; Pilgaard Ulrichsen, S.; Boriani, G.; Sturkenboom, M. C. J.; De Ponti, F.; Trifirò, G.
abstract

Purpose: After regulatory restrictions for terfenadine and astemizole in ‘90s, only scarce evidence on proarrhythmic potential of antihistamines has been published. We evaluate the risk of ventricular tachyarrhythmia (VA) related to the use of individual antihistamines. Methods: A matched case-control study nested in a cohort of new users of antihistamines was conducted within the EU-funded ARITMO project. Data on 1997–2010 were retrieved from seven healthcare databases: AARHUS (Denmark), GEPARD (Germany), HSD and ERD (Italy), PHARMO and IPCI (Netherlands) and THIN (UK). Cases of VA were selected and up to 100 controls were matched to each case. The odds ratio (OR) of current use for individual antihistamines (AHs) was estimated using conditional logistic regression. Results: For agents largely used to prevent allergic symptoms, such as cetirizine, levocetirizine, loratadine, desloratadine and fexofenadine, we found no VA risk. A statistically significant, increased risk of VA was found only for current use of cyclizine in the pooled analysis (ORadj, 5.3; 3.6–7.6) and in THIN (ORadj, 5.3; 95% CI, 3.7–7.6), for dimetindene in GEPARD (ORadj, 3.9; 1.1–14.7) and for ebastine in GEPARD (ORadj, 3.3; 1.1–10.8) and PHARMO (ORadj, 4.6; 1.3–16.2). Conclusions: The risk of VA associated with a few specific antihistamines could be ascribable to heterogeneity in pattern of use or in receptor binding profile.

2017 - Use of statins and adverse outcomes in patients with atrial fibrillation: An analysis from the EURObservational Research Programme Atrial Fibrillation (EORP-AF) general registry pilot phase [Articolo su rivista]
Proietti, Marco; Laroche, Cécile; Nyvad, Ole; Haberka, Maciej; Vassilikos, Vassilios P.; Maggioni, Aldo P.; Boriani, Giuseppe; Lip, Gregory Y. H.
abstract

Background Despite oral anticoagulation being highly effective in reducing stroke and thromboembolism, patients with atrial fibrillation (AF) still have a significant residual excess in mortality risk. Additional management strategies are needed to reduce the mortality risk seen in AF patients. Methods Ancillary analysis from the EURObservational Research Programme Atrial Fibrillation (EORP-AF) General Pilot Registry, to evaluate 1-year outcomes in AF patients according to statin use at baseline. Results Of 2636 patients, 1286 (48.8%) patients used statins at baseline. Patients prescribed statins had more comorbidities. At 1-year follow-up, logistic regression analysis adjusted for AF type, symptomatic status and CHA2DS2-VASc score demonstrated that statin use was inversely associated with CV death (odds ratio [OR]: 0.50, 95% confidence interval [CI]: 0.30–0.82, p &lt; 0.0001), all-cause death (OR: 0.52, 95% CI: 0.37–0.73, p &lt; 0.0001) and the composite outcome of CV death/any thromboembolic event/bleeding (OR: 0.71, 95% CI: 0.52–0.98, p &lt; 0.0001). Similar findings were observed for ‘high risk’ subgroups including the elderly, primary prevention and high thromboembolic risk AF patients. Survival analysis showed that statins prescribed patients had a lower risk of all-cause death at follow-up (p = 0.0433). Multivariate Cox regression analysis found that statin use remained independently associated with a lower risk for all-cause death (hazard ratio [HR]: 0.61, 95% CI: 0.42–0.88, p = 0.0077). Conclusions Statin use in AF patients was associated with improved outcomes, with an independent association with a lower risk of all-cause death at 1-year follow-up.

2017 - [Clinical practice for the diagnosis of cardiac arrhythmias in patients on renal replacement therapy: data from a Lombard survey] [Articolo su rivista]
Genovesi, Simonetta; Nava, Elisa; Pasa, Alice; Corghi, Enzo; Ondei, Patrizia; Marta, Elisabetta; Bellasi, Antonio; Malberti, Fabio; Teatini, Ugo; Guastoni, Carlo Maria; Spatola, Leonardo; Luise, Maria Carmen; Tiboldo, Renza; Bertoli, Silvio; Messa, Piergiorgio; Doria, Maria; Gallieni, Maurizio; Cozzolino, Mario; Spotti, Donatella; Sala, Valeria; Sironi, Elisabetta; Boriani, Giuseppe
abstract

Among dialysis patients, 40% of deaths are due to cardiovascular causes, and 60% of cardiac deaths are due to an arrhythmia. The purpose of this survey, carried out with the organizational support of the Lombard Section of the Italian Society of Nephrology, is to evaluate the frequency and mode of use of non-invasive instruments for the diagnosis of cardiac arrhythmias in the dialysis centers of Lombardy. Information on the prevalence and type of cardiac devices at December 1, 2016 in this population was also required. Data from 18 centers were collected for a total of 3395 patients in replacement renal therapy, including 2907 (85.6%) in hemodialysis and 488 (14.4%) in peritoneal dialysis. All centers use the 12-lead ECG in case of evocative symptoms of an arrhythmic event and 2/3 perform the exam with programmed cadence (usually once a year). Twenty four-hour ECG Holter is not used as a routine diagnostic tool. The proportion of cardiac devices is relatively high, compared to literature data: n=259, equal to 7.6% of the population. Pace-Maker patients are 166 (4.9%), those with intracardiac defibrillator 52 (1.5%), those with resynchronization therapy 18 (0.5%) and those with resynchronization therapy and intracardiac defibrillator 23 (0.7%). The survey provides interesting information and can be an important starting point for trying to optimize clinical practice and collaboration between nephrologists and cardiologists in front of a major problem like that of arrhythmic disease in patients on renal replacement therapy.

2016 - 'Real-world' management and outcomes of patients with paroxysmal vs. non-paroxysmal atrial fibrillation in Europe: The EURObservational Research Programme-Atrial Fibrillation (EORP-AF) General Pilot Registry [Articolo su rivista]
Boriani, Giuseppe; Laroche, Cecile; Diemberger, Igor; Fantecchi, Elisa; Popescu, Mircea Ioachim; Rasmussen, Lars Hvilsted; Dan, Gheorghe Andrei; Kalarus, Zbigniew; Tavazzi, Luigi; Maggioni, Aldo P.; Lip, Gregory Y. H.
abstract

Aims Atrial fibrillation (AF) has different presentations (first detected, paroxysmal, persistent, permanent), with uncertain impact on outcome. The aim of this study was to investigate clinical presentation, management, and outcome of paroxysmal and non-paroxysmal AFs within the EURObservational Research Programme-Atrial Fibrillation General Pilot Registry. Methods and results Overall 2589 patients with available 1-year follow-up data were evaluated according to AF type. Patients with paroxysmal AF (26.8%) were younger, had lower prevalence of heart disease (particularly valvular), and major co-morbidities, as well as lower CHADS2, CHA2DS2-VASc, and HAS-BLED scores. Patients with first-detected AF (29.9%) had characteristics similar to persistent AF patients (25.9%), but lower use of oral anticoagulants. Patients with permanent AF represented 17.4% of the cohort. At 1 year, the rate of stroke/transient ischaemic attack and thromboembolism was low (0.6-1.0%) and did not differ between paroxysmal and non-paroxysmal AFs. All-cause mortality was higher in non-paroxysmal vs. paroxysmal AF (log rank test, P = 0.0018). Using a multivariable Cox model, non-paroxysmal AF was not an independent predictor of death during follow-up. Independent predictors of death were age, chronic heart failure, chronic kidney disease, diabetes, restrictive cardiomyopathy, and physical activity. Conclusion In this 'real-world' contemporary observational registry, patients with non-paroxysmal AF had a worse outcome, in terms of all-cause mortality, which was related to a more severe clinical profile. The risk of stroke at 1 year was relatively low, perhaps reflecting the high rates of anticoagulation use in this cohort.

2016 - 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing [Articolo su rivista]
Wilkoff, Bruce L.; Fauchier, Laurent; Stiles, Martin K.; Morillo, Carlos A.; Al Khatib, Sana M.; Almendral, Jesús; Aguinaga, Luis; Berger, Ronald D.; Cuesta, Alejandro; Daubert, James P.; Dubner, Sergio; Ellenbogen, Kenneth A.; Estes, N. A. Mark; Fenelon, Guilherme; Garcia, Fermin C.; Gasparini, Maurizio; Haines, David E.; Healey, Jeff S.; Hurtwitz, Jodie L.; Keegan, Roberto; Kolb, Christof; Kuck, Karl Heinz; Marinskis, Germanas; Martinelli, Martino; Mcguire, Mark; Molina, Luis G.; Okumura, Ken; Proclemer, Alessandro; Russo, Andrea M.; Singh, Jagmeet P.; Swerdlow, Charles D.; Teo, Wee Siong; Uribe, William; Viskin, Sami; Wang, Chun Chieh; Zhang, Shu; Boriani, Giuseppe; Brignole, Michele; Cheng, Alan; Crawford, Thomas C.; Di Biase, Luigi; Donahue, Kevin; Epstein, Andrew E.; Field, Michael E.; Gorenek, Bulent; Huang, Jin Long; Indik, Julia H.; Israel, Carsten W.; Jessup, Mariell L.; Leclercq, Christophe; Macfadyen, Robert J.; Madias, Christopher; Marquez, Manlio F.; Olshansky, Brian; Patton, Kristen K.; Refaat, Marwan M.; Tracy, Cynthia M.; Upadhyay, Gaurav A.; Vanegas, Diego; Wang, Paul J.
abstract

N/A

2016 - A roadmap to improve the quality of atrial fibrillation management: Proceedings from the fifth Atrial Fibrillation Network/European Heart Rhythm Association consensus conference [Articolo su rivista]
Kirchhof, Paulus; Breithardt, Günter; Bax, Jeroen; Benninger, Gerlinde; Blomstrom Lundqvist, Carina; Boriani, Giuseppe; Brandes, Axel; Brown, Helen; Brueckmann, Martina; Calkins, Hugh; Calvert, Melanie; Christoffels, Vincent; Crijns, Harry; Dobrev, Dobromir; Ellinor, Patrick; Fabritz, Larissa; Fetsch, Thomas; Freedman, S. Ben; Gerth, Andrea; Goette, Andreas; Guasch, Eduard; Hack, Guido; Haegeli, Laurent; Hatem, Stephane; Haeusler, Karl Georg; Heidbüchel, Hein; Heinrich Nols, Jutta; Hidden Lucet, Francoise; Hindricks, Gerd; Juul Möller, Steen; Kääb, Stefan; Kappenberger, Lukas; Kespohl, Stefanie; Kotecha, Dipak; Lane, Deirdre A.; Leute, Angelika; Lewalter, Thorsten; Meyer, Ralf; Mont, Lluis; Münzel, Felix; Nabauer, Michael; Nielsen, Jens C.; Oeff, Michael; Oldgren, Jonas; Oto, Ali; Piccini, Jonathan P.; Pilmeyer, Art; Potpara, Tatjana; Ravens, Ursula; Reinecke, Holger; Rostock, Thomas; Rustige, Joerg; Savelieva, Irene; Schnabel, Renate; Schotten, Ulrich; Schwichtenberg, Lars; Sinner, Moritz F.; Steinbeck, Gerhard; Stoll, Monika; Tavazzi, Luigi; Themistoclakis, Sakis; Tse, Hung Fat; Van Gelder, Isabelle C.; Vardas, Panagiotis E.; Varpula, Timo; Vincent, Alphons; Werring, David; Willems, Stephan; Ziegler, André; Lip, Gregory Y. H.; Camm, A. John
abstract

At least 30 million people worldwide carry a diagnosis of atrial fibrillation (AF), and many more suffer from undiagnosed, subclinical, or 'silent' AF. Atrial fibrillation-related cardiovascular mortality and morbidity, including cardiovascular deaths, heart failure, stroke, and hospitalizations, remain unacceptably high, even when evidence-based therapies such as anticoagulation and rate control are used. Furthermore, it is still necessary to define how best to prevent AF, largely due to a lack of clinical measures that would allow identification of treatable causes of AF in any given patient. Hence, there are important unmet clinical and research needs in the evaluation and management of AF patients. The ensuing needs and opportunities for improving the quality of AF care were discussed during the fifth Atrial Fibrillation Network/European Heart Rhythm Association consensus conference in Nice, France, on 22 and 23 January 2015. Here, we report the outcome of this conference, with a focus on (i) learning from our 'neighbours' to improve AF care, (ii) patient-centred approaches to AF management, (iii) structured care of AF patients, (iv) improving the quality of AF treatment, and (v) personalization of AF management. This report ends with a list of priorities for research in AF patients.

2016 - A tailored treatment strategy: A modern approach for stroke prevention in patients with atrial fibrillation [Articolo su rivista]
Lip, G. Y. H.; Potpara, T; Boriani, Giuseppe; Blomström Lundqvist, C.
abstract

The main priority in atrial fibrillation (AF) management is stroke prevention, following which decisions about rate or rhythm control are focused on the patient, being primarily for management of symptoms. Given that AF is commonly associated with various comorbidities, risk factors such as hypertension, heart failure, diabetes mellitus and sleep apnoea should be actively looked for and managed in a holistic approach to AF management. The objective of this review is to provide an overview of modern AF stroke prevention with a focus on tailored treatment strategies. Biomarkers and genetic factors have been proposed to help identify 'high-risk' patients to be targeted for oral anticoagulation, but ultimately their use must be balanced against that of more simple and practical considerations for everyday use. Current guidelines have directed focus on initial identification of 'truly low-risk' patients with AF, that is those patients with a CHA2 DS2 -VASc [congestive heart failure, hypertension, age ≥75 years (two points), diabetes mellitus, stroke (two points), vascular disease, age 65-74 years, sex category] score of 0 (male) or 1 (female), who do not need any antithrombotic therapy. Subsequently, patients with ≥1 stroke risk factors can be offered effective stroke prevention, that is oral anticoagulation. The SAMe-TT2 R2 [sex female, age &lt;60 years, medical history (&gt;2 comorbidities), treatment (interacting drugs), tobacco use (two points), race non-Caucasian (two points)] score can help physicians make informed decisions on those patients likely to do well on warfarin (SAMe-TT2 R2 score 0-2) or those who are likely to have a poor time in therapeutic range (SAMe-TT2 R2 score &gt;2). A clinically focused tailored approach to assessment and stroke prevention in AF with the use of the CHA2 DS2 VASc, HAS-BLED [hypertension, abnormal renal/liver function (one or two points), stroke, bleeding history or predisposition, labile international normalized ratio, elderly (&gt;65 years) drugs/alcohol concomitantly (one or two points)] and SAMeTT2 R2 scores to evaluate stroke risk, bleeding risk and likelihood of successful warfarin therapy, respectively, is discussed.

2016 - Atrial fibrillation and aging: Risky mutual relationships [Articolo su rivista]
Boriani, Giuseppe
abstract

N/A

2016 - Atrial fibrillation burden and atrial fibrillation type: Clinical significance and impact on the risk of stroke and decision making for long-term anticoagulation [Articolo su rivista]
Boriani, Giuseppe; Pettorelli, Daniele
abstract

Atrial fibrillation (AF) is a common arrhythmia increasing the risk of morbidity and adverse outcomes (stroke, heart failure, death). AF is found in 1–2% of the general population, with increasing prevalence with aging. Its exact epidemiological profile is incomplete and underestimated, because 10–40% of AF patients (particularly the elderly) can be asymptomatic (“clinically silent or subclinical AF”), with occasional electrocardiographic diagnosis. The research interest on silent AF has increased by the evidence that its outcome is no less severe, in terms of risks of stroke and death, than that for symptomatic patients. Data collected from more than 18,000 patients indicate that cardiac implantable electrical devices (CIEDs) are validated tools for detecting silent AF and measuring the time spent in AF, defined as “AF burden.” A maximum daily AF burden of ≥ 5–6 min, but particularly ≥ 1 h, is associated with a significant increase in the risk of stroke, and may be clinically relevant to improve current risk stratification based on risk scores and for “personalizing” prescription of oral anticoagulants. An in-depth study of the temporal relationship between AF and ischemic stroke showed that data from CIEDs reveal a complex scenario, by which AF is certainly a risk factor for cardioembolic stroke, with a cause–effect relationship related to atrial thrombi, but can also be a simple “marker of risk,” with a noncausal association with stroke. In such cases, stroke is possibly related to atheroemboli from the aorta, the carotid arteries, or other sources.

2016 - Automatic management of atrial and ventricular stimulation in a contemporary unselected population of pacemaker recipients: The ESSENTIAL Registry [Articolo su rivista]
Biffi, Mauro; Bertini, Matteo; Saporito, Davide; Belotti, Giuseppina; Quartieri, Fabio; Piancastelli, Maurizio; Pucci, Angelo; Boggian, Giulio; Mazzocca, Gian Franco; Giorgi, Davide; Diotallevi, Paolo; Diemberger, Igor; Martignani, Cristian; Pancaldi, Stefano; Ziacchi, Matteo; Marcantoni, Lina; Toselli, Tiziano; Attala, Simone; Iori, Matteo; Bottoni, Nicola; Argnani, Selina; Tomasi, Corrado; Sassone, Biagio; Boriani, Giuseppe
abstract

Aims We investigated the applicability of the Ventricular Capture Control (VCC) and Atrial Capture Control (ACC) algorithms for automatic management of cardiac stimulation featured by Biotronik pacemakers in a broad, unselected population of pacemaker recipients. Methods and results Ventricular Capture Control and Atrial Capture Control were programmed to work at a maximum adapted output voltage as 4.8 V in consecutive recipients of Biotronik pacemakers. Ambulatory threshold measurements were made 1 and 12 months after pacemaker implant/replacement in all possible pacing/sensing configurations, and were compared with manual measurements. Among 542 patients aged 80 (73-85) years, 382 had a pacemaker implant and 160 a pacemaker replacement. Ventricular Capture Control could work at long term in 97% of patients irrespectively of pacing indication, lead type, and lead service life, performance being superior with discordant pacing/sensing configurations. Atrial Capture Control could work in 93% of patients at 4.8 V maximum adapted voltage and at any pulse width, regardless of pacing indication, lead type, and service life. At 12-month follow-up, a ventricular threshold increase ≥1.5 V had occurred in 4.4% of patients uneventfully owing to VCC functioning. Projected pacemaker longevity at 1 month was strongly correlated with the 12-month estimate, and exceeded 13 years in &gt;60% of patients. Conclusion These algorithms for automatic management of pacing output ensure patient safety in the event of a huge increase of pacing threshold, while enabling maximization of battery longevity. Their applicability is quite broad in an unselected pacemaker population irrespectively of lead choice and service of life.

2016 - BLOCK HF: How far does it extend indications for cardiac resynchronization therapy? [Articolo su rivista]
Boriani, Giuseppe; Ziacchi, Matteo; Diemberger, Igor; Biffi, Mauro; Martignani, Cristian; Leyva, Francisco
abstract

The Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block (BLOCK HF) trial, published in April 2013 [Curtis AB, Worley SJ, Adamson PB, et al; Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block (BLOCK HF) Trial Investigators. Biventricular pacing for atrioventricular block and systolic dysfunction. N Engl J Med 2013; 368:1585-1593], explored whether cardiac resynchronization therapy (CRT) was superior to conventional pacing in patients with conventional indications for pacing, left ventricular dysfunction and NYHA (New York Heart Association) class I-III. The trial took 8 years and a source of concern is selection bias, because participating centers had an average of two patients enrolled per center, per year. Both the internal and external validity of the trial merit some comments. BLOCK HF showed a relatively low treatment effect of CRT as compared with other CRT trials. As a matter of fact, the absolute risk reduction for death or hospitalization because of heart failure was 4.8%, in a relatively long follow-up, with a number needed to treat (NNT) of 21, much higher than the NNT of other CRT trials. We estimate that at least one third of patients in BLOCK HF could meet current indications for CRT. Moreover, the study did not consider the additional risks and costs of CRT versus conventional pacing, both having important implications for cost-effectiveness estimates. For these and other reasons, uncertainties arise as to how far BLOCK HF extends current recommendations for CRT and how much it should be implemented in daily clinical practice.

2016 - Battery drain in daily practice and medium-term projections on longevity of cardioverterdefibrillators: An analysis from a remote monitoring database [Articolo su rivista]
Boriani, Giuseppe; Ritter, Philippe; Biffi, Mauro; Ziacchi, Matteo; Diemberger, Igor; Martignani, Cristian; Valzania, Cinzia; Valsecchi, Sergio; Padeletti, Luigi; Gadler, Fredrik
abstract

Aims The longevity of generators is a crucial determinant of the cost-effectiveness of therapy with implantable cardioverterdefibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D). We evaluated the trend of devicemeasured residual battery capacity and longevity projections over 5-year follow-up.We also investigated possible factors associated with battery drain. Methods and results Data from 4851 patients in the European LATITUDEw database who were followed up for a minimum of 3 years were analysed. The factors associated with battery drain (i.e. year-to-year decrease in residual battery capacity), and thus potentially impacting on device longevity, were mainly the pacing parameters in CRT-D devices and the number of shocks delivered and diverted in both ICD and CRT-D (all P &lt; 0.01 on linear regression analysis). Over the first 5 years, the longevity estimates provided by devices showed low intra-patient variability and increased with time. The estimates exceeded 10 years for CRT-Dand 13 and 12 years for single- and dual-chamber ICDs, respectively. In CRT-D patients, the expected patient age on replacement was 80±12 years, and the expected probability of undergoing device replacement was 63±13% for New York Heart Association (NYHA) II patients and 37±16% for NYHA III patients. For comparison, the probabilities of replacing a CRT-D lasting 5 years were 78±8 and 59±13%, respectively (both P, 0.001). Conclusion Battery drain was mainly associated with pacing output in CRT-D devices and with the number of capacitor charges in both ICD and CRT-D devices. The longevity estimates provided by the devices were consistent and conservative. According to these estimates, among CRT-D recipients a low proportion of patients should require device replacement.

2016 - Beat-to-beat analysis of P waves in patient with atrial fibrillation history [Relazione in Atti di Convegno]
Corino, Valentina D. A; Censi, Federica; Tesoro, Marianna; Corazza, Ivan; Reggiani, Elisa; Boriani, Giuseppe; Mainardi, Luca T.
abstract

P wave morphology has been shown to be modified in patients with paroxysmal atrial fibrillation (AF) and in healthy subjects of different age. These changes are commonly evaluated in the signal averaged ECG, thus in average P waves. Aim of this study is to assess beat-to-beat variations in P wave characteristics. Five-minute 12-lead ECG were recorded from 10 healthy subjects (C group), 10/10 patients with/without an AF recurrence (R/NR groups), after electrical cardioversion. Principal component analysis was performed on a beat-to-beat basis. The dynamic of the first three eigenvalues series and the beat-to-beat variability of the first three principal components (PCs) morphology were analyzed by calculating the distance between the average morphology over all the beats acquired and the morphology identified on each beat for the first three PCs. Most of the indexes were statistically different between C group and the patients with history of AF, highlighting higher regularity of the eigenvalues series as well as more similar PCs in healthy subjects. In addition, the series of the first eigenvalues was significantly less regular in R group compared NR group (Reg: 0.029 ± 0.020, 0.062 ± 0.033, p<0.05, R vs NR group).

2016 - Beat-to-beat variability of P-wave in patients suffering from atrial fibrillation [Relazione in Atti di Convegno]
Censi, Federica; Calcagnini, Giovanni; Mattei, Eugenio; Ricci, Alessandro; Corazza, Ivan; Reggiani, Elisa; Boriani, Giuseppe
abstract

The aim of this paper was to analyze the P-wave variability over time in patients suffering from Atrial Fibrillation (AF). Behind some time-domain and morphological features of the P-wave template, two novel indexes of P-wave variability have been estimated: one based on the cross-correlation coefficients among the P-waves (Correlation Index, CI), and one associated to variation of P-waves amplitude (Amplitude Index, AI). These indexes were estimated in two experimental models: patients suffering from persistent AF respect to control subjects and patients developing post-operative AF (POAF) after coronary artery bypass grafting respect to patients without POAF. The control group resulted to be characterized by shorter P-wave duration and by a less amount of fragmentation and variability, respect to AF patients (with a sensitivity and specificity of 98.4% and 95 % respectively). Also P-wave features resulted to be different for patients with POAF respect to patients without. In conclusion the quantification of the P-wave variability over time can add information in the understanding of the association between the anatomical atrial substrate and atrial arrhythmias.

2016 - Cardiac Resynchronization Therapy with a Quadripolar Electrode Lead Decreases Complications at 6 Months Results of the MORE-CRT Randomized Trial [Articolo su rivista]
Boriani, Giuseppe; Connors, Sean; Kalarus, Zbigniew; Lemke, Bernd; Mullens, Wilfried; Osca Asensi, Joaquin; Raatikainen, Pekka; Gazzola, Carlo; Farazi, Taraneh G.; Leclercq, Christophe
abstract

Objectives The aim of this study was to test the hypothesis that a quadripolar left ventricular (LV) lead results in fewer LV lead-related events than a bipolar cardiac resynchronization therapy (CRT) system in a prospective randomized trial. Background Bipolar LV leads cannot be implanted at the optimal site in up to 10% of patients who need CRT, because of anatomic or technical challenges (pacing threshold, phrenic stimulation, or mechanical instability). Methods The MORE-CRT (More Options Available With a Quadripolar LV Lead Provide In-Clinic Solutions to CRT Challenges) trial enrolled 1,078 patients. Patients with indications for CRT defibrillator therapy were randomized into 2 groups in a 1:2 ratio: a group with a bipolar CRT lead system (the BiP group; any manufacturer) and a group with a quadripolar CRT system (the Quad group; Quartet LV lead). The primary endpoint was freedom from a composite endpoint of intraoperative and post-operative LV lead-related events at 6 months. Results A total of 1,074 of 1,078 patients (99%) were randomized and contributed to the primary endpoint. Freedom from the composite endpoint was significantly greater in the Quad than the BiP group (83.0% vs. 74.4%, p = 0.0002). The intraoperative component of the endpoint was met less frequently by Quad group patients (6.26% Quad vs. 12.1% BiP), whereas there was no difference for the post-operative component (7.1% Quad vs. 7.6% BiP). Conclusions The Quartet LV system significantly reduced total LV lead-related events at 6 months after implantation compared with a bipolar CRT system. The reduction in events demonstrates the superiority of this quadripolar technology to effectively manage CRT patients. (More Options Available With a Quadripolar LV Lead Provide In-Clinic Solutions to CRT Challenges [MORE-CRT]; NCT01510652).

2016 - Cardiac device therapy in patients with left ventricular dysfunction and heart failure: ‘real-world’ data on long-term outcomes (mortality, hospitalizations, days alive and out of hospital) [Articolo su rivista]
Boriani, Giuseppe; Berti, Elena; Belotti, Laura Maria Beatrice; Biffi, Mauro; De Palma, Rossana; Malavasi, Vincenzo L.; Bottoni, Nicola; Rossi, Luca; De Maria, Elia; Mantovan, Roberto; Zardini, Marco; Casali, Edoardo; Marconi, Marco; Bandini, Alberto; Tomasi, Corrado; Boggian, Giulio; Barbato, Gaetano; Toselli, Tiziano; Zennaro, Mauro; Sassone, Biagio
abstract

Background: The impact on long-term outcomes of implantable cardioverter defibrillators (ICDs) and biventricular defibrillators for cardiac resynchronization (CRT-D) devices in ‘real world’ patients with heart failure (HF) needs to be assessed in terms of clinical effectiveness. Methods and results: A registry including consecutive HF patients who underwent a first implant of an ICD (891 patients) or a CRT-D device (709 patients) in 2006–2010 was followed (median 1487 days and 1516 days, respectively), collecting administrative data on survival, all-cause hospitalizations, cardiovascular or HF hospitalizations, and days alive and out of hospital (DAOH). Survival free from death/cardiac transplant was 61.9% and 63.8% at 5 years for ICD and CRT-D patients, respectively. Associated comorbidities (Charlson Comorbidity Index) had a significant impact on death/cardiac transplant, as well as on hospitalizations. The median values of DAOH% were 97.4% for ICD and 97.7% for CRT-D patients, but data were highly skewed, with the lower quartile of DAOH% values including values ranging between 0% and 52.8% for ICD and between 0% and 56.1% for CRT-D patients. Charlson Comorbidity Index was a very strong predictor of DAOH%. Conclusions: Patients who were implanted in ‘real world’ clinical practice with an ICD or a CRT-D device have, on average, a relatively favourable outcome, with a survival of around 62–64% at 5 years, but with an important burden of hospitalizations. Comorbidities, as evaluated by means of the Charlson Comorbidity Index, have a significant impact on outcomes in terms of mortality/heart transplant, hospitalizations and days spent alive and out of hospital.

2016 - Cause of death and predictors of all-cause mortality in anticoagulated patients with nonvalvular atrial fibrillation: Data from ROCKET AF [Articolo su rivista]
Pokorney, Sean D; Piccini, Jonathan P.; Stevens, Susanna R.; Patel, Manesh R.; Pieper, Karen S.; Halperin, Jonathan L.; Breithardt, Günter; Singer, Daniel E.; Hankey, Graeme J.; Hacke, Werner; Becker, Richard C.; Berkowitz, Scott D.; Nessel, Christopher C.; Mahaffey, Kenneth W.; Fox, Keith A. A.; Califf, Robert M.; Anderson, J.; Bedwell, N.; Bilsker, M.; Bruce, G.; Agah, R.; Desantis, M.; Eisenberg, S.; Flores, A.; Herzog, W.; Klein, S.; Snyder, H.; Krueger, S.; Almaguer, E.; Lavie, E.; Lee, C.; Mallis, G.; Modi, M.; Woodworth, G.; Niazi, I.; Peart, B.; Sundaram, S.; Snoddy, B.; Sotolongo, R.; Moloney, J.; Vijayaraghavan, K.; Whittier, F.; Yellen, L.; Banerjee, S.; Lustgarten, D.; Suresh, D.; Gelernt, M.; Levinson, L.; Ghanekar, R.; Niazi, I.; Kneller, G.; Hall, C.; Fadl, Y.; Suresh, D.; Pirwitz, M.; French, W.; Mayer, N.; Pugeda, J.; Steel, K.; Mody, F.; Malik, A.; Chandna, H.; Go, A.; Emlein, G.; Bowden, W.; Moscoso, R.; Hodson, R.; Berk, M.; Pan, D.; Pappas, J.; Orchard, R.; Lynchard, G.; Vijay, N.; Khan, W.; El Khadra, M.; Antonishen, M.; Cucher, F.; Staab, M.; Zebrack, J.; Borromeo, S.; Heilman, J.; Chaturvedi, S.; Makam, S.; Turk, S.; Hyers, T.; Williams, G.; Labroo, A.; Gill, S.; Myears, D.; Weinstein, J.; Shanes, J.; Chandrashekhar, Y.; Shah, S.; Reiter, W.; Logemann, T.; Almquist, A.; Bhagwat, R.; Tak, T.; Shen Ling, J.; Patel, P.; Artis, A.; Arouni, A.; Lauer, M.; Kinney, K.; Elsen, J.; Roan, P.; Villafria, R.; Sumpter, M.; Ip, J.; Welka, S.; Schifferdecker, B.; Sandoval, R.; Speirs, S.; Jones, A.; Haldis, T.; Kazmierski, J.; Sutherland, J.; Dietrich, D.; Telfer, E.; Berry, J.; Mcelveen, A.; Russell, J.; Sackett, M.; Antonios, N.; Smith, D.; Vora, K.; Kirby, A.; Lui, H.; Mego, D.; Ziada, K.; Navas, J.; Taussig, A.; Koren, M.; Vogel, C.; Saba, F.; Parrott, C.; Schneider, R.; Shirwany, A.; Rubin, M.; Treasure, C.; Bertolet, B.; Chang, M.; Langberg, J.; Becker, R.; Cohen, Y.; Mcgrew, F.; White, J.; Arzola, F.; Zelenka, J.; Tannenbaum, A.; Fernandes, V.; Jamnadas, P.; Agamasu, J.; Collins, B.; Jauch, W.; Sasseen, B.; Hotchkiss, D.; Abadier, R.; Osunkoya, A.; Schlau, A.; Chappel, C.; Foster, M.; Braun, E.; Mostel, E.; Capo, J.; Ashchi, M.; Howard, V.; Albirini, A.; Burger, A.; Rolston, D.; Staniloae, C.; Bacon, J.; Wiseman, A.; Mcgarvey, J.; Sonel, A.; Hamroff, G.; Chang, D.; Daboul, N.; Broderick, G.; Meholick, A.; Corbelli, J.; Silverman, R.; Raffetto, J.; Fishberg, R.; Georgeson, S.; Held, J.; Seidner, M.; Saint Jacques, H.; Heitner, J.; Kutalek, S.; Friedlander, I.; Hutchinson, B.; Walia, J.; Kondo, N.; Smiley, N.; Blitz, L.; Dale, H.; Sulman, S.; Szulawski, I.; Modares, F.; Martin, R.; Nahhas, A.; Renzi, M.; Akyea Djamson, A.; Alfieri, A.; Sandhu, J.; Voyce, S.; Amaram, S.; Meyerrose, G.; Shoukfeh, M.; Lee, F.; Villegas, B.; Idowu, O.; Khera, A.; Sam, C.; Vo, A.; Lieber, I.; Smith, T.; Awan, N.; Tsai, C.; Ganim, R.; Alzaghrini, G.; Pitt, W.; Shepherd, A.; Tang, S.; Go, A.; Stoltz, S.; Nelson, W.; Cox, S.; Meymandi, S.; Melucci, M.; Thomas, G.; Gogia, H.; Machell, C.; Chandrasekaran, S.; Brown, C.; Jetty, P.; Miller, G.; Dykstra, G.; Jaffrani, N.; Zakhary, B.; Caruso, A.; Zolty, R.; Fox, D.; Jacobs, G.; Lebenthal, M.; Mukherjee, S.; Zimetbaum, P.; Kingsley, J.; Jones, R.; Robinson, V.; Kenton, D.; Usedom, J.; Williams, S.; Snipes, C.; Wilson, V.; Hasty, R.; Shoemaker, J.; Donahue, M.; Al Saghir, Y.; Thomsen, E.; Yarows, S.; Chastain, S.; Mclaughlin, P.; Wakham, M.; Shrestha, D.; Simmons, J.; Fisher, D.; Seymour, Z.; Frandsen, B.; First, B.; Sharpe, C.; Popeil, L.; Guthrie, R.; Hunter, J.; Alvarado, O.; Sandberg, J.; Gutman, N.; Belber, A.; Arkhipov, M.; Ballyzek, M.; Baranov, A.; Barbarash, O.; Barbarich, V.; Belenky, D.; Berkovich, O.; Bokarev, I.; Boyarkin, M.; Vaniev, S.; Volkova, E.; Gratsiansky, N.; Demin, A.; Zadionchenko, V.; Zateyshchikov, D.; Zrazhevsky, K.; Mazaev, V.; Martynov, A.; Mikhailov, S.; Mkrtchian, V.; Novozhenov, V.; Raskina, T.; Rebrov, A.; Sanina
abstract

Background-Atrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all-cause mortality may guide interventions. Methods and Results-In the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose-adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all-cause mortality in the 14 171 participants in the intentionto- treat population. The median age was 73 years, and the mean CHADS2 score was 3.5. Over 1.9 years of median follow-up, 1214 (8.6%) patients died. Kaplan-Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all-cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33-1.70, P&lt;0.0001) and age ≥75 years (hazard ratio 1.69, 95% CI 1.51-1.90, P&lt;0.0001) were associated with higher all-cause mortality. Multiple additional characteristics were independently associated with higher mortality, with decreasing creatinine clearance, chronic obstructive pulmonary disease, male sex, peripheral vascular disease, and diabetes being among the most strongly associated (model C-index 0.677). Conclusions-In a large population of patients anticoagulated for nonvalvular atrial fibrillation, ≈7 in 10 deaths were cardiovascular, whereas &lt;1 in 10 deaths were caused by nonhemorrhagic stroke or systemic embolism. Optimal prevention and treatment of heart failure, renal impairment, chronic obstructive pulmonary disease, and diabetes may improve survival.

2016 - EACVI/EHRA Expert Consensus Document on the role of multi-modality imaging for the evaluation of patients with atrial fibrillation [Articolo su rivista]
Donal, Erwan; Lip, Gregory Y. H; Galderisi, Maurizio; Goette, Andreas; Shah, Dipen; Marwan, Mohamed; Lederlin, Mathieu; Mondillo, Sergio; Edvardsen, Thor; Sitges, Marta; Grapsa, Julia; Garbi, Madalina; Senior, Roxy; Gimelli, Alessia; Potpara, Tatjana S; Van Gelder, Isabelle C; Gorenek, Bulent; Mabo, Philippe; Lancellotti, Patrizio; Kuck, Karl-Heinz; Popescu, Bogdan A; Hindricks, Gerhard; Habib, Gilbert; Boriani, Giuseppe
abstract

Atrial fibrillation (AF) is the commonest cardiac rhythm disorder. Evaluation of patients with AF requires an electrocardiogram, but imaging techniques should be considered for defining management and driving treatment. The present document is an expert consensus from the European Association of Cardiovascular Imaging (EACVI) and the European Heart Rhythm Association. The clinical value of echocardiography, cardiac magnetic resonance (CMR), computed tomography (CT), and nuclear imaging in AF patients are challenged. Left atrial (LA) volume and strain in echocardiography as well as assessment of LA fibrosis in CMR are discussed. The value of CT, especially in planning interventions, is highlighted. Fourteen consensus statements have been reached. These may serve as a guide for both imagers and electrophysiologists for best selecting the imaging technique and for best interpreting its results in AF patients.

2016 - Effect of Cardiac Resynchronization Therapy on Left Atrial Size and Function as Expressed by Speckle Tracking 2-Dimensional Strain [Articolo su rivista]
Valzania, Cinzia; Gadler, Fredrik; Boriani, Giuseppe; Rapezzi, Claudio; Eriksson, Maria J.
abstract

Changes in left atrial (LA) strain in patients treated with cardiac resynchronization therapy (CRT) remain not entirely explored. We prospectively evaluated long-term changes in LA size and function and their relation with left ventricular (LV) reverse remodeling and noninvasive hemodynamic variables in patients treated with CRT by 2-dimensional speckle tracking echocardiography. Thirty patients (62 ± 11 years, 63% men) underwent 2-dimensional speckle tracking echocardiography before implant and after 12 months. LA area, global and regional LA strains, LV ejection fraction (LVEF) and longitudinal strain, mitral regurgitation (MR), and diastolic variables were evaluated. At 12 months, CRT responders (60%) exhibited an increase in LA strain (11.4 ± 6.5% vs 16.5 ± 7.9%, p &lt;0.001) and a reduction in LA area (p = 0.002), which were associated with an improvement in MR, E/E′ ratio, LVEF, and LV longitudinal strain. In nonresponders, a worsening in LA strain (11.4 ± 6.8% vs 8.7 ± 4.6%, p = 0.017) and LA area (p = 0.002) occurred in parallel with an increase in E/E′, whereas LVEF and LV longitudinal strain were unchanged. In conclusion, over long-term follow-up, LA size and strain improved in CRT responders, while worsening in nonresponders. Changes in LV function, filling pressures, and MR seem to be related to LA reverse remodeling, giving a feedback loop.

2016 - Effect of telemonitoring of cardiac implantable electronic devices on healthcare utilization: A meta-analysis of randomized controlled trials in patients with heart failure [Articolo su rivista]
Klersy, Catherine; Boriani, Giuseppe; De Silvestri, Annalisa; Mairesse, Georges H.; Braunschweig, Frieder; Scotti, Valeria; Balduini, Anna; Cowie, Martin R.; Leyva, Francisco
abstract

Aims Implantable device telemonitoring (DTM) is a diagnostic adjunct to traditional face-to-face hospital visits. Remote device follow-up and earlier diagnoses facilitated by DTM should reduce healthcare utilization. We explored whether DTM reduces healthcare utilization over standard of care (SoC), without compromising patient outcomes. Methods and results This systematic review and meta-analysis of 11 randomized controlled trials on DTM in patients with heart failure consisted of 5702 patients, with a median of 117 [interquartile range (IQR) 76-331] patients per study [age 65 years (IQR 63-67)] and follow-up range of 12-36 months. DTM was associated with a reduction in total number of visits [planned, unplanned, and emergency room (ER)] [relative risk (RR) 0.56; 95% confidence interval (CI) 0.43-0.73, P &lt; 0.001]. Rates of cardiac hospitalizations (RR 0.96; 95% CI 0.82-1.12, P = 0.60) and the composite endpoints of ER, unplanned hospital visits, or hospitalizations (RR 0.99; 95% CI 0.68-1.43, P = 0.96) was similar between the DTM and the SoC groups. An increase in the total number of ER or unscheduled visits (RR 1.37; 95% CI 1.11-1.70, P = 0.004) was observed. This effect was consistent and statistically significant for all studies. Total and cardiac mortality were similar between the groups (DTM RR 0.90; 95% CI 0.69-1.16, P = 0.41; and DTM RR 0.93; 95% CI 0.51-1.69, P = 0.80). Monetary costs favoured DTM (10-55% reduction in five studies). Conclusions Compared with SoC, DTM is associated with a marked reduction in planned hospital visits. In addition, DTM was associated with lower monetary costs, despite a modest increase in unplanned hospital and ER visits. DTM did not compromise survival.

2016 - Electrocardiographic Eligibility for Subcutaneous Implantable Cardioverter Defibrillator: Evaluation during Bicycle Exercise [Articolo su rivista]
Ziacchi, Matteo; Corzani, Alessandro; Diemberger, Igor; Martignani, Cristian; Marziali, Alessandro; Mazzotti, Andrea; Massaro, Giulia; Rapezzi, Claudio; Biffi, Mauro; Boriani, Giuseppe
abstract

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is used in patients at risk of sudden death. Our aim was to assess clinical predictors of electrocardiographic ineligibility for S-ICD, and the impact of exercise on S-ICD eligibility in an unselected series of patients requiring ICD therapy. Methods: 102 patients at risk of sudden death were evaluated at rest and during exercise. Electrocardiograph screening using limb lead electrodes (to simulate the S-ICD sensing vectors) was performed at rest and during bicycle ergometer exercise. Results: R wave amplitude in lead D3 during exercise &gt;16 mV, baseline QTc and the sum of amplitudes of the R waves at supine &gt;30 mV were predictors of ineligibility for S-ICD. Eligibility increased from 90% to 100% of patients when evaluated with an "any of the three leads" criterion compared to current recommendations. A more restrictive criterion based on two of three ECG leads caused an eligibility drop at 66%, that further decreased to 56% during exercise; these figures improved to 79% and 81%, respectively, when an "any 2 of 3 leads" criterion was used. Conclusions: Huge ECG amplitude and QTc duration are associated with ineligibility in the current S-ICD release. By performing exercise testing, lead suitability changes in one patient out of 14 (7% of tested patients) and eligibility is decreased by use of a more stringent criterion for eligibility (ECG criteria satisfied in two of three leads). A dynamic selection of sensing vectors aiming at situation-specific suitability (any of three leads) would increase S-ICD eligibility to 100% of patients.

2016 - Establishing and Managing a Device Clinic and Database [Capitolo/Saggio]
Boriani, G.; Wilkoff, B. L.
abstract

2016 - Executive Summary: European Heart Rhythm Association Consensus Document on the Management of Supraventricular Arrhythmias [Articolo su rivista]
Katritsis, Demosthenes G.; Boriani, Giuseppe; Cosio, Francisco G.; Jais, Pierre; Hindricks, Gerhard; Josephson, Mark E.; Keegan, Roberto; Knight, Bradley P.; Kuck, Karl Heinz; Lane, Deirdre A.; Lip, Gregory Y. H.; Malmborg, Helena; Oral, Hakan; Pappone, Carlo; Themistoclakis, Sakis; Wood, Kathryn A.; Young Hoon, Kim; Lundqvist, Carina Blomström
abstract

This paper is an executive summary of the full European Heart Rhythm Association (EHRA) consensus document on the management of supraventricular arrhythmias, published in Europace. It summarises developments in the field and provides recommendations for patient management, with particular emphasis on new advances since the previous European Society of Cardiology guidelines. The EHRA consensus document is available to read in full at http://europace.oxfordjournals.org.

2016 - Glomerular filtration rate in patients with atrial fibrillation and 1-year outcomes [Articolo su rivista]
Boriani, Giuseppe; Laroche, C; Diemberger, I; Popescu, Mi; Rasmussen, Lh; Petrescu, L; Crijns, Hj; Tavazzi, L; Maggioni, Ap; Lip, G. Y.
abstract

We assessed 1-year outcomes in patients with atrial fibrillation enrolled in the EurObservational Research Programme AF General Pilot Registry (EORP-AF), in relation to kidney function, as assessed by glomerular filtration rate (eGFR). In a cohort of 2398 patients (median age 69 years; 61% male), eGFR (ml/min/1.73 m(2)) calculated using the CKD-EPI formula was ≥80 in 35.1%, 50-79 in 47.2%, 30-49 in 13.9% and &lt;30 in 3.7% of patients. In a logistic regression analysis, eGFR category was an independent predictor of stroke/TIA or death, with elevated odds ratios associated with severe to mild renal impairment, ie. eGFR &lt; 30 ml/min/1.73 m(2) [OR 3.641, 95% CI 1.572-8.433, p &lt; 0.0001], 30-49 ml/min/1.73 m(2) [OR 3.303, 95% CI 1.740-6.270, p = 0.0026] or 50-79 ml/min/1.73 m2 [OR 2.094, 95% CI 1.194-3.672, p = 0.0003]. The discriminant capability for the risk of death was tested among various eGFR calculation algorithms: the best was the Cockcroft-Gault equation adjusted for BSA, followed by Cockcroft-Gault equation, and CKD-EPI equation, while the worst was the MDRD equation. In conclusion in this prospective observational registry, renal function was a major determinant of adverse outcomes at 1 year, and even mild or moderate renal impairments were associated with an increased risk of stroke/TIA/death.

2016 - Guía ESC 2015 sobre el tratamiento de pacientes con arritmiasventriculares y prevención de la muerte súbita cardiaca [Articolo su rivista]
Priori, Silvia G; Blomström Lundqvist, Carina; Mazzanti, Andrea; Blom, Nico; Borggrefe, Martin; Camm, John; Elliott, Perry Mark; Fitzsimons, Donna; Hatala, Robert; Hindricks, Gerhard; Kirchhof, Paulus; Kjeldsen, Keld; Kuck, Karl Heinz; Hernández Madrid, Antonio; Nikolaou, Nikolaos; Norekvål, Tone M.; Spaulding, Christian; Van Veldhuisen, Dirk J.; Kolh, Philippe; Lip, Gregory Y. H.; Agewall, Stefan; Barón Esquivias, Gonzalo; Boriani, Giuseppe; Budts, Werner; Bueno, Héctor; Capodanno, Davide; Carerj, Scipione; Crespo Leiro, María G.; Czerny, Martin; Deaton, Christi; Dobrev, Dobromir; Erol, Çetin; Galderisi, Maurizio; Gorenek, Bulent; Kriebel, Thomas; Lambiase, Pier; Lancellotti, Patrizio; Lane, Deirdre A.; Lang, Irene; Manolis, Athanasios J.; Morais, Joao; Moreno, Javier; Piepoli, Massimo F.; Rutten, Frans H.; Sredniawa, Beata; Zamorano, José L.; Zannad, Faiez
abstract

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2016 - Impact of chronic obstructive pulmonary disease on prognosis in atrial fibrillation: A report from the EURObservational Research Programme Pilot Survey on Atrial Fibrillation (EORP-AF) General Registry [Articolo su rivista]
Proietti, Marco; Laroche, Cécile; Drozd, Marcin; Vijgen, Johan; Cozma, Dragos C.; Drozdz, Jaroslaw; Maggioni, Aldo P.; Boriani, Giuseppe; Lip, Gregory Y. H.
abstract

Chronic obstructive pulmonary disease (COPD) is a common chronic disease, being associated with both high rates of morbidity and mortality. Similarly, atrial fibrillation (AF) is associated with a higher risk of both cardiovascular (CV) events and overall mortality. The AF and COPD often coexist, but the impact of COPD on prognosis in European AF patients is unknown. Methods We evaluated COPD prevalence in patients enrolled in the EURObservational Research Programme Pilot Survey on Atrial Fibrillation Registry Pilot Phase. Clinical factors associated with COPD and adverse outcomes at 1-year follow-up were determined. Results In the overall cohort, a diagnosis of COPD was recorded in 339 (11.0%) of AF patients. The AF patients with COPD were more burdened with risk factors and comorbidities, including diabetes mellitus (P &lt;.0001) and chronic heart failure (P &lt;.0001). β-Blockers were less likely to be prescribed to patients with COPD (P =.0007). On follow-up, AF patients with COPD had a higher risk of both CV death and all-cause death (both P &lt;.0001), as well as for the composite outcome of any thromboembolic event/bleeding /CV death (P =.0003). Cox regression analysis found that COPD was independently associated with an increase in all-cause death (hazard ratio, 1.55; 95% CI 1.05-2.28; P =.0269). Conclusions Chronic obstructive pulmonary disease is highly prevalent in European AF patients, and is associated with higher rates of CV death, all-cause death, and the composite outcome of any thromboembolic event/bleeding/CV death. The presence of COPD in AF patients was independently associated with all-cause death in AF patients.

2016 - Implant rates of cardiac implantable electrical devices in Europe: A systematic literature review [Articolo su rivista]
Valzania, Cinzia; Torbica, Aleksandra; Tarricone, Rosanna; Leyva, Francisco; Boriani, Giuseppe
abstract

Background: In recent years, indications for cardiac implantable electrical devices (CIEDs) have broadened; however, budget constraints can significantly impact patient access to these life-saving health technologies. Objective: To perform a systematic literature review on the implant rates of pacemakers, cardioverter-defibrillators, and cardiac resynchronization therapy devices in Europe over the last decade to provide insight into the possible reasons for differences across regions or countries. Methods: Four electronic databases were searched to find studies describing CIED implant rates in Europe. Fifty-eight studies were included. Results: An overview showed a recent rise in CIED implants, with large geographic differences. The ratio between the regions with the highest and lowest implant rates within the same country ranged between 1.3 and 3.4 for pacemakers and between 1.7 and 44.0 for defibrillators. The ratio between the countries with the highest and lowest implant rates ranged between 2.3 and 87.5 for pacemakers, between 3.1 and 1548.0 for defibrillators, and between 4.1 and 221.0 for resynchronization therapy devices. Implant rate variability appears to be influenced by health care, economic, demographic, and cultural factors. Conclusion: Publications on CIED implant rates in Europe show a wide variability within and across countries, the determinants of which are only partially investigated. Policy making should improve regarding equity of access to better care.

2016 - Implantable cardioverter-defibrillator programming and electrical storm: Results of the OBSERVational registry On long-term outcome of ICD patients (OBSERVO-ICD) [Articolo su rivista]
Guerra, Federico; Palmisano, Pietro; Dell'Era, Gabriele; Ziacchi, Matteo; Ammendola, Ernesto; Bonelli, Paolo; Patani, Francesca; Cupido, Claudio; Devecchi, Chiara; Accogli, Michele; Occhetta, Eraldo; Santangelo, Lucio; Biffi, Mauro; Boriani, Giuseppe; Capucci, Alessandro
abstract

BACKGROUND Electrical storm (ES) is defined as 3 or more episodes of ventricular fibrillation (VF) or ventricular tachycardia (VT) within 24 hours and is associated with increased cardiac and all-cause mortality.OBJECTIVE The purpose of this study was to test whether aggressive implantable cardioverter-defibrillator (ICD) programming can be associated with ES.METHODS The OBSERVational registry On long-term outcome of ICD patients (OBSERVO-ICD) is a multicenter, retrospective registry enrolling all consecutive patients undergoing ICD implantation from 2010 to 2012 in 5 Italian high-volume arrhythmia centers. Clinical history and risk factors were collected for all patients, as were ICD therapy-related variables such as detection zones and delays. The total number of arrhythmic episodes and therapies delivered by the ICD were collected through out-of-hospital visits and remote monitoring.RESULTS The registry enrolled 1319 consecutive patients, of whom 62 (4.7%) experienced at least 1 ES during follow-up (median 39 months). Patients who experienced ES had a significantly lower VF detection zone (P =.002), more frequently had antitachycardia pacing therapies programmed off during capacitor charge (P =.001), and less frequently had an ICD set with delayed therapies for VT zones (P =.042) and VF zone (P =.036). Patients who experienced ES had a significantly higher incidence of death and heart failure-related death compared to patients with no ventricular arrhythmias and patients with unclustered VTs/VFs (P =.025 and P &lt;.001, respectively).CONCLUSION Patients with ES had a more aggressive ICD programming setup, including lower VF detection rates, shorter detection times, and no antitachycardia pacing therapies during capacitor charge. This kind of ICD programming potentially could increase the likelihood of ES and the related risk of death.

2016 - Left Ventricular Reverse Remodeling Elicited by a Quadripolar Lead: Results from the Multicenter Per4mer Study [Articolo su rivista]
Ziacchi, Matteo; Saporito, Davide; Zardini, Marco; Luzi, Mario; Quartieri, Fabio; Morgagni, Gianluigi; De Maria, Elia; Bertini, Matteo; Carinci, Valeria; Boriani, Giuseppe; Biffi, Mauro
abstract

Background To understand the impact of a quadripolar left ventricular (LV) lead on reverse remodeling and phrenic nerve stimulation (PNS) in congestive heart failure patients treated by cardiac resynchronization therapy at 8-month follow-up (FU). Methods One hundred and fifty-eight patients received an LV Medtronic Performa lead (Medtronic Inc., Minneapolis, MN, USA) and were reevaluated at FU by echocardiography and measurement of electrical parameters. Results A targeted LV lead placement was achieved in 140 (89%) patients. Super responders and responders were 76 (50%) and 26 (18%), respectively, at FU; seven (4%) died and 13 (8%) were hospitalized for any cause. Nonischemic etiology was the only independent predictor of reverse remodeling. The configurations available only with the Performa leads reduced PNS occurrence at 8 V@0.4 ms from 43 (27%) to 14 (9%) of patients at implantation, and from 44 (28%) to 19 (12%) at last FU, compared to configurations available with bipolar leads. Patients with detectable PNS had &gt;10/16 pacing configurations with a PNS safety margin &gt;2 V both at implantation and at FU. During FU 16 (10%) patients had an adverse event possibly related to the lead or to modification of the underlying heart disease but 99% of these events were fixed by reprogramming of the pacing vector. Conclusions Performa Lead enables an increased capability to achieve a targeted lead positioning in the broad clinical scenario of large- and small-volume implanting centers, with a relevant impact on the occurrence of reverse remodeling compared to literature data. The enhanced management of PNS resulted in a dislodgement rate of only 1%.

2016 - Linee guida ESC 2015 per il trattamento dei pazienti con aritmie ventricolari e la prevenzione della morte cardiaca improvvisa: Task Force per il Trattamento dei Pazienti con Aritmie Ventricolari e la Prevenzione della Morte Cardiaca Improvvisa della Società Europea di Cardiologia (ESC) [Articolo su rivista]
Priori, Silvia G.; Blomström Lundqvist, Carina; Mazzanti, Andrea; Bloma, Nico; Borggrefe, Martin; Camm, John; Elliott, Perry Mark; Fitzsimons, Donna; Hatala, Robert; Hindricks, Gerhard; Kirchhof, Paulus; Kjeldsen, Keld; Kuck, Karl Heinz; Hernandez Madrid, Antonio; Nikolaou, Nikolaos; Norekvål, Tone M.; Spaulding, Christian; Van Veldhuisen, Dirk J.; Kolh, Philippe; Lip, Gregory Y. H.; Agewall, Stefan; Barón Esquivias, Gonzalo; Boriani, Giuseppe; Budts, Werner; Bueno, Héctor; Capodanno, Davide; Carerj, Scipione; Crespo Leiro, Maria G.; Czerny, Martin; Deaton, Christi; Dobrev, Dobromir; Erol, Çetin; Galderisi, Maurizio; Gorenek, Bulent; Kriebel, Thomas; Lambiase, Pier; Lancellotti, Patrizio; Lane, Deirdre A.; Lang, Irene; Manolis, Athanasios J.; Morais, Joao; Moreno, Javier; Piepoli, Massimo F.; Rutten, Frans H.; Sredniawa, Beata; Zamorano, Jose L.; Zannad, Faiez
abstract

N/A

2016 - Modelling projections for the uptake of edoxaban in an European population to 2050: Effects on stroke, thromboembolism, and health economics perspectives [Articolo su rivista]
Blann, Andrew D.; Boriani, Giuseppe; Lip, Gregory Y. H.
abstract

Aims In the coming decades, the number of Europeans with atrial fibrillation (AF) is set to rise as the population ages, and so with it will the number of strokes. The risk of thromboembolism (principally stroke and systemic embolism) and death can be reduced by the use of the vitamin K antagonists (VKA, e.g. warfarin) and more so by non-VKA oral anticoagulants (NOACs) such as edoxaban. Methods and results We modelled the effect of the increasing use of edoxaban in preference to warfarin in a European AF population from both clinical and economic perspectives. We estimate that the introduction of NOACs in 2010 eliminated over 88 000 thromboembolisms and deaths annually, of which over 17 000 were ischaemic strokes. At a 1-year cost of €30k per ischaemic stroke, this strategy saved €510 million annually. Should the use of edoxaban increase from 11% in 2013 to 75% by 2030, we expect that rate of thromboembolism and death will fall from 5.67 to 5.42 total events per million patients per year, which will further eliminate over 12 000 of these events annually. At an inflation-adjusted 1-year cost of approximately €35k per ischaemic stroke, this will save €44.5 million each year. At a conservative rate of increase in the AF population of 2.2-fold from 2005, in 2050 there will be around 180 000 AF-related ischaemic strokes that, at an inflation-adjusted cost of around €62k per stroke, sums to €11 116 million. Should the rate of AF rise 2.6-fold from 2005, then in 2050 there will be 214 500 ischaemic strokes that will cost around €13 300 million. Conclusion Our data point to a substantial increase in the human and economic cost burden of AF and so emphasize the need to reduce this burden. This may be achieved by the increased use of oral anticoagulants, particularly with the NOACs such as edoxaban.

2016 - P-wave Variability and Atrial Fibrillation [Articolo su rivista]
Censi, Federica; Corazza, Ivan; Reggiani, Elisa; Calcagnini, Giovanni; Mattei, Eugenio; Triventi, Michele; Boriani, Giuseppe
abstract

The analysis of P-wave template has been widely used to extract indices of Atrial Fibrillation (AF) risk stratification. The aim of this paper was to assess the potential of the analysis of the P-wave variability over time in patients suffering from atrial fibrillation. P-wave features extracted from P-wave template together with novel indices of P-wave variability have been estimated in a population of patients suffering from persistent AF and compared to those extracted from control subjects. We quantify the P-wave variability over time using three algorithms and we extracted three novel indices: one based on the cross-correlation coefficients among the P-waves (Cross-Correlation Index, CCI), one associated to variation in amplitude of the P-waves (Amplitude Dispersion Index, ADI), one sensible to the phase shift among P-waves (Warping Index, WI). The control group resulted to be characterized by shorter P-wave duration and by a less amount of fragmentation and variability, respect to AF patients. The parameter CCI shows the highest sensitivity (97.3%) and a good specificity (95%).

2016 - Predictors of nonsimultaneous interventricular delay at cardiac resynchronization therapy optimization [Articolo su rivista]
Ziacchi, Matteo; Diemberger, Igor; Biffi, Mauro; Martignani, Cristian; Bertini, Matteo; Rocchi, Guido; Biagini, Elena; Graziosi, Maddalena; Mazzotti, Andrea; Rapezzi, Claudio; Boriani, Giuseppe
abstract

Aim Cardiac resynchronization is a well tolerated and effective therapy for heart failure, but 30% of patients still do not respond to biventricular pacing. Optimization of device settings, in particular interventricular delay value, represents a plausible target for improving these results, but available literature is discordant. We aimed our study at the identification of the best suitable candidates to interventricular delay optimization. Methods A total of 77 consecutive patients with optimized drugs therapy underwent clinical, echocardiographic and electrocardiographic evaluation before and after 6 months from implantation of a biventricular defibrillator in accordance to current guidelines. In each patient, atrioventricular and interventricular delay values were optimized at predischarge with echocardiogram. Results The only predictor of an optimized interventricular delay value different from simultaneous (i.e. standard shipment setting), at both univariate and multivariate analyses, was a QRS duration greater than 160ms (odds ratio 22.958; PU0.003) with a sensitivity of 70.9%. Conclusion Candidates to cardiac resynchronization therapy with a basal QRS greater than 160ms have a higher chance of requiring echo-guided tailoring of interventricular delay value. A strategy based on these data can potentially improve device programming, reducing by one-third the need for optimization, according to our findings, and at the same time avoid unnecessary timeconsuming procedures.

2016 - Prognostic implications of mitral regurgitation in patients after cardiac resynchronization therapy [Articolo su rivista]
Cipriani, Manlio; Lunati, Maurizio; Landolina, Maurizio; Proclemer, Alessandro; Boriani, Giuseppe; Ricci, Renato P.; Rordorf, Roberto; Matassini, Maria Vittoria; Padeletti, Luigi; Iacopino, Saverio; Molon, Giulio; Perego, Giovanni B.; Gasparini, Maurizio
abstract

Aim: Mitral regurgitation (MR) is a common finding in patients with heart failure with debatable effects on prognosis. Reduction in MR is one of the mechanisms by which cardiac resynchronization therapy (CRT) exerts its beneficial effects. We investigated the prognostic impact of baseline MR and MR persistence after CRT on outcomes of treated patients. Methods and results: We prospectively followed 1122 CRT patients (66.4 ± 10.3 years, 78% male) who were stratified according to baseline MR severity as having MR− (degree 0–1; n = 508, 45%) or MR+ (degrees 2–3–4; n = 614, 55%). In 916 patients (82%) with MR severity data available at 1-year follow-up, the annual mortality rate was 3.4 and 6.0 per patient-year in the MR− and MR+ group, respectively, with a 1-year incidence rate ratio (IRR) of 1.76 (P &lt; 0.001). Similar results were observed for cardiovascular mortality (1-year IRR 1.72, P = 0.002). When considering survival according to MR severity after CRT, all-cause and cardiovascular mortality were lower in the improved than in the worsened group (1-year IRR 1.87 and 2.33, respectively; both P &lt; 0.001). Regression analysis showed that absence of MR improvement at follow-up was a significant independent predictor of both all-cause and cardiovascular mortality. Conclusions: Baseline significant MR and absence of MR improvement after CRT are strongly predictive of less favourable long-term survival.

2016 - Psychological correlates, allostatic overload and clinical course in patients with implantable cardioverter defibrillator (ICD) [Articolo su rivista]
Gostoli, Sara; Bonomo, Matteo; Roncuzzi, Renzo; Biffi, Mauro; Boriani, Giuseppe; Rafanelli, Chiara
abstract

Background Implantable cardioverter defibrillator (ICD) is a key treatment option for both primary and secondary prevention of sudden cardiac death. Despite this, there is a growing number of studies showing that ICD is often associated with post-implantation deleterious psychosocial effects, even in the absence of medical complications. Knowledge about the predictive role of pre-ICD psychological profile is scant. The present research aims to describe patients' pre-ICD psychological profile, focusing on acute and chronic distress, such as anxiety, depression, type D personality, psychosomatic syndromes and allostatic overload (AO), and to evaluate if these psychological variables could affect ICD outcomes and survival. Methods 117 consecutive patients (74.4% males; mean age&nbsp;=&nbsp;63.1&nbsp;±&nbsp;13.7&nbsp;years) underwent psychological assessment prior to ICD implantation. Data on ICD-related complications and death were collected up to 26&nbsp;months after the intervention. Results At baseline, 36.8% of the sample had anxiety and 17.9% depression. Among psychosomatic syndromes, psychological factors affecting medical conditions were the most frequent (37.6%). 12.8% presented with type D personality, whereas 16.2% showed moderate AO and 4.3% severe AO. 25.6% of the patients had post-ICD complications and 6% died. Severe AO was the only predictor of survival. Conclusion Our findings show that a reliable evaluation of stress and the inability to cope with it (allostatic overload) may help to identify patients at higher risk of post-ICD complications and death. Such sensitive index, more than traditional psychiatric diagnostic criteria, may help the physician to identify easily manifestations of distress and clinically relevant information, which could affect medical illness outcomes.

2016 - Reduction of inappropriate anti-tachycardia pacing therapies and shocks by a novel suite of detection algorithms in heart failure patients with cardiac resynchronization therapy defibrillators: A historical comparison of a prospective database [Articolo su rivista]
Lunati, Maurizio; Proclemer, Alessandro; Boriani, Giuseppe; Landolina, Maurizio; Locati, Emanuela; Rordorf, Roberto; Daleffe, Elisabetta; Ricci, Renato Pietro; Catanzariti, Domenico; Tomasi, Luca; Gulizia, Michele; Baccillieri, Maria Stella; Molon, Giulio; Gasparini, Maurizio
abstract

Aims Implantable cardioverter defibrillators improve survival of patients at risk for ventricular arrhythmias, but inappropriate shocks occur in up to 30% of patients and have been associated with worse quality of life and prognosis. In heart failure patients with cardiac resynchronization therapy defibrillators (CRT-Ds), we evaluated whether a new generation of detection and discrimination algorithms reduces inappropriate shocks. Methods and results We analysed 1983 Medtronic CRT-D patients (80% male, 67±10 years), 1368 with standard devices (Control CRTD) and 615 with new generation devices (New CRT-D). Expert electrophysiologists reviewed and classified the electrograms of all device-detected ventricular tachycardia/fibrillation episodes. Total follow-up was 3751 patients-years. Incidence of inappropriate shocks at 1 year was 2.8% [95% confidence interval (CI) = 2.0-3.5] in Control CRT-D and 0.9% (CI = 0.4-2.2) in New CRT-D (hazard ratio = 0.37, CI = 0.21-0.66, P &lt; 0.001). In New CRT-D, inappropriate shocks were reduced by 77% [incidence rate ratio (IRR) = 0.23, CI = 0.16-0.35, P &lt; 0.001] and inappropriate antitachycardia pacing by 81% (IRR = 0.19, CI = 0.11-0.335, P &lt; 0.001). Annual rate per 100 patient-years for appropriate VF detections was 3.0 (CI = 2.1-4.2) in New CRT-D and 3.2 (CI = 2.1-5.0) in Control CRT-D (P = 0.68), for syncope was 0.4 (CI = 0.2-0.9) in New CRT-D and 0.7 (CI = 0.5-1.0) in Control CRT-D (P = 0.266), and for death was 1.0 (CI = 0.6-1.6) in New CRT-D and 3.5 (CI = 3.0-4.1) in Control CRT-D (P &lt; 0.001). Conclusion Detection and discrimination algorithms used in new generation CRT-D significantly reduced inappropriate shocks when compared with standard CRT-D. This result, with no compromise on VF sensitivity or risk of syncope, has important implications for patients' quality of life and prognosis.

2016 - Switching among Equivalents in Chronic Cardiovascular Therapies: 'Real World' Data from Italy [Articolo su rivista]
Poluzzi, Elisabetta; Veronese, Giacomo; Piccinni, Carlo; Raschi, Emanuel; Koci, Ariola; Pagano, Paola; Godman, Brian; Marchesini, Giulio; Boriani, Giuseppe; De Ponti, Fabrizio
abstract

Since August 2012, Italian general practitioners are required to prescribe the generic name of medicines, except for refill of chronic therapy. We evaluated the extent of switching among equivalents in chronic cardiovascular therapies, the influence of the 2012 regulatory intervention and of patient-related or drug-related factors. Prescriptions of off-patent anti-arrhythmics, oral antidiabetics and ACE inhibitors dispensed from August 2011 to August 2013 within the Bologna Local Health Authority (870,000 inhabitants) was collected. The rate of actual switching among equivalents was evaluated monthly. The effect of the regulatory intervention was estimated by interrupted-time-series analysis. Adjusted odds ratios (aORs) of switching were calculated for the following: age, gender, number of different equivalents available for each drug and change in dispensing pharmacy between subsequent refills. The average monthly rates of switches were 9.6%, 16.3% and 16.3% for anti-arrhythmics, antidiabetics and ACE inhibitors, respectively. Values significantly increased soon after the regulatory intervention for ACE inhibitors (+1.81%, p &lt; 0.01), anti-arrhythmics (+1.46%, p = 0.01) and antidiabetics (+1.09%, p = 0.01), and no significant decreasing trends were observed in the following 12 months. For all drug classes, odd of switching was higher in case of change in dispensing pharmacy (up to aOR = 4.31, 95 CI = 4.26-4.35 for ACE inhibitors) and availability of ≥5 different equivalents (up to aOR = 7.82, 95 CI = 7.39-8.28 for antidiabetics). Switching was lower for age ≥65 for antidiabetics and ACE inhibitors (aOR = 0.92, 95 CI = 0.90-0.93; 0.87, 0.86-0.88, respectively). The Italian regulatory intervention generated an immediate increase, not sustained in time, in switching among equivalents of cardiovascular therapies. Young age, high number of available equivalents and changes in dispensing pharmacy between subsequent refills were associated with switching.

2016 - Tailored treatment strategies: A new approach for modern management of atrial fibrillation [Articolo su rivista]
Van Gelder, I. C; Hobbelt, A. H.; Marcos, E. G.; Schotten, U.; Cappato, R.; Lewalter, T.; Schwieler, J.; Rienstra, M.; Boriani, Giuseppe
abstract

Atrial fibrillation (AF) is not benign. Cardiovascular diseases and risk factors differ importantly amongst patients. Careful phenotyping with the aim to start tailored therapy may improve outcome and quality of life. Furthermore, structural remodelling plays an important role in initiation and progression of AF. Therapies that interfere in the remodelling processes are promising because they may modify the atrial substrate. However, success is still limited probably due to variations in the underlying substrate in individual patients. The most favourable effects of lifestyle changes on success of rhythm control have been demonstrated in obese patients with AF. Differences in genotype may also play an important role. Common gene variants have been associated with recurrence of AF after electrical cardioversion, antiarrhythmic drug therapy and catheter ablation. Therefore, both phenotyping and genotyping may become useful for patient selection in the future. Beside the choice of rate or rhythm control, and type of rhythm control, prevention of complications associated with AF may also differ depending on genotype and phenotype. Efficacy of stroke prevention has been well established, but bleeding remains a clinically relevant problem. Risk stratification is still cumbersome, especially in low-risk patients and in those with a high bleeding risk. The decision whether to start anticoagulation (and if so which type of anticoagulant) or, alternatively, to implant an occlusion device of the left atrial appendage may also be improved by genotyping and phenotyping. In this review, we will summarize new insights into the roles of phenotype and genotype in generating more tailored treatment strategies in patients with AF and discuss several patient-tailored treatment options. Content List - Read more articles from the symposium: Atrial fibrillation - from atrial extrasystoles to atrial cardiomyopathy. What have we learned from basic science and interventional procedures.

2016 - The Impact of Diabetes and Comorbidities on the Outcome of Heart Failure Patients Treated with Cardiac Resynchronization Therapy: Implications for Patient Management [Articolo su rivista]
Boriani, Giuseppe
abstract

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2016 - The ventricular ectopic QRS interval (VEQSI): Diagnosis of arrhythmogenic right ventricular cardiomyopathy in patients with incomplete disease expression [Articolo su rivista]
Bastiaenen, Rachel; Pantazis, Antonis; Gonna, Hanney; Chis Ster, Irina; Castelletti, Silvia; Batchvarov, Velislav N.; Domenichini, Giulia; Coccolo, Fabio; Boriani, Giuseppe; Mckenna, William J.; Behr, Elijah R.; Gallagher, Mark M.
abstract

Background The ventricular ectopic QRS interval (VEQSI) has been shown to identify structural heart disease and predict mortality. In arrhythmogenic right ventricular cardiomyopathy (ARVC), early diagnosis is difficult using current methods, and life-threatening arrhythmias are common and difficult to predict. Objective The purpose of this study was to assess the utility of ventricular ectopic indices including VEQSI in ARVC diagnosis. Methods We studied 70 patients with ARVC [30 with definite disease (age 47 ± 12 years; 60% male), 40 with incomplete disease expression (age 44 ± 18 years; 44% male)], 116 healthy controls (age 40 ± 15 years; 56% male), and 26 patients with normal heart right ventricular outflow tract (RVOT) ectopy (age 46 ± 17 years; 27% male). The duration of the broadest ventricular ectopic beat during 12-lead Holter monitoring was recorded as VEQSI max. Results VEQSI max was associated with age and gender, but not with conducted QRS duration. Adjusted VEQSI max was greater in ARVC patients than in control groups. In healthy males (44.5 years), estimated VEQSI max was 163 ms (95% confidence interval [CI] 159-167 ms); in definite ARVC 212 ms (95% CI 206-217 ms); in incompletely expressed ARVC 204 ms (95% CI 199-210 ms); and in normal heart RVOT ectopy 171 ms (95% CI 165-178 ms). VEQSI max &gt;180 ms had 98% sensitivity and specificity for diagnosis of ARVC (area under the curve 0.99, 95% CI 0.980-0.998). In our incompletely expressed ARVC patients, VEQSI max &gt;180 ms identified 88% as affected. Conclusion VEQSI max distinguishes ARVC patients, including those with incomplete disease expression, from healthy controls and patients with normal heart RVOT ectopy.

2016 - Usefulness of Electrocardiographic Patterns at Presentation to Predict Long-term Risk of Cardiac Death in Patients With Hypertrophic Cardiomyopathy [Articolo su rivista]
Biagini, Elena; Pazzi, Chiara; Olivotto, Iacopo; Musumeci, Beatrice; Limongelli, Giuseppe; Boriani, Giuseppe; Pacileo, Giuseppe; Mastromarino, Vittoria; Bacchi Reggiani, Maria Letizia; Lorenzini, Massimiliano; Lai, Francesco; Berardini, Alessandra; Mingardi, Francesca; Rosmini, Stefania; Resciniti, Elvira; Borghi, Claudia; Autore, Camillo; Cecchi, Franco; Rapezzi, Claudio
abstract

The objective of this study was to investigate the prognostic significance of 12-lead electrocardiogram (ECG) patterns in a large multicenter cohort of patients with hypertrophic cardiomyopathy; 1,004 consecutive patients with hypertrophic cardiomyopathy and a recorded standard ECG (64% men, mean age 50 ± 16 years) were evaluated at 4 Italian centers. The study end points were sudden cardiac death (SCD) or surrogates, including appropriate implanted cardiac defibrillator discharge and resuscitated cardiac arrest and major cardiovascular events (including SCD or surrogates and death due to heart failure, cardioembolic stroke, or heart transplantation). Prevalence of baseline electrocardiographic characteristics was: normal ECG 4%, ST-segment depression 56%, pseudonecrosis waves 33%, "pseudo-ST-segment elevation myocardial infarction (STEMI)" pattern 17%, QRS duration ≥120 ms 17%, giant inverted T waves 6%, and low QRS voltages 3%. During a mean follow-up of 7.4 ± 6.8 years, 77 patients experienced SCD or surrogates and 154 patients experienced major cardiovascular events. Independent predictors of SCD or surrogates were unexplained syncope (hazard ratio [HR] 2.5, 95% confidence interval [CI] 1.4 to 4.5, p = 0.003), left ventricular ejection fraction &lt;50% (HR 3.5, 95% CI 1.9 to 6.7, p = 0.0001), nonsustained ventricular tachycardia (HR 1.7, 95% CI 1.1 to 2.6, p = 0.027), pseudo-STEMI pattern (HR 2.3, 95% CI 1.4 to 3.8, p = 0.001), QRS duration ≥120 ms (HR 1.8, 95% CI 1.1 to 3.0, p = 0.033), and low QRS voltages (HR 2.3, 95% CI 1.01 to 5.1, p = 0.048). Independent predictors of major cardiovascular events were age (HR 1.02, 95% CI 1.01 to 1.03, p = 0.0001), LV ejection fraction &lt;50% (HR 3.73, 95% CI 2.39 to 5.83, p = 0.0001), pseudo-STEMI pattern (HR 1.66, 95% CI 1.13 to 2.45, p = 0.010), QRS duration ≥120 ms (HR 1.69, 95% CI 1.16 to 2.47, p = 0.007), and prolonged QTc interval (HR 1.68, 95% CI 1.21 to 2.34, p = 0.002). In conclusion, a detailed qualitative and quantitative electrocardiographic analyses provide independent predictors of prognosis that could be integrated with the available score systems to improve the power of the current model.

2016 - Ventricular antitachycardia pacing therapy in patients with heart failure implanted with a cardiac resynchronization therapy defibrillator device: Efficacy, safety, and impact on mortality [Articolo su rivista]
Landolina, Maurizio; Lunati, Maurizio; Boriani, Giuseppe; Pietro Ricci, Renato; Proclemer, Alessandro; Facchin, Domenico; Rordorf, Roberto; Morani, Giovanni; Maines, Massimiliano; Gasparini, Gianni; Molon, Giulio; Turrini, Pietro; Gasparini, Maurizio
abstract

Background Cardiac resynchronization therapy defibrillator can terminate ventricular tachycardia (VT) and fast VT (FVT) via antitachycardia pacing (ATP). Objectives We evaluated efficacy and safety of ATP, whether ATP induces ventricular arrhythmias after inappropriate ATP or atrial fibrillation (AF) after appropriate ATP, and whether ATP is associated with mortality. Methods A total of 1404 patients with a cardiac resynchronization therapy defibrillator were followed in a prospective multicenter observational research. All-cause mortality rates were estimated in patient subgroups in order to uncouple the trigger (VT/FVT or other rhythms causing inappropriate detections) from ATP therapy. Results Over a median follow-up of 31 months, 2938 VT/FVT episodes were treated with ATP in 360 patients. The adjusted ATP success rate was 63% (95% confidence interval [CI] 57%-69%) on FVTs and 68% (95% CI 62%-74%) on VTs. Acceleration occurred in 55 (1.87%) and syncope in 4 (0.14%) of all ATP-treated episodes. In 14 true VT/FVT episodes in 5 patients, AF followed ATP therapy. In 4 episodes in 2 patients, VT followed ATP inappropriately applied during AF. Death rate per 100 patient-years was 5.6 (95% CI 4.3-7.5) in patients with appropriate ATP and 1.5 (95% CI 0.4-6.1) in patients with inappropriate ATP (P =.045). Conclusion ATP was effective in terminating VT/FVT episodes and displayed a good safety profile. ATP therapies by themselves did not increase death risk; prognosis was indeed better in patients without arrhythmic episodes, even if they received inappropriate ATP, than in patients with ATP on VT/FVT episodes. Adverse outcomes observed in patients receiving implantable cardioverter-defibrillator therapies are probably related to the arrhythmia itself, a marker of disease progression, rather than to adverse effects of ATP.

2015 - 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death the Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC) Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC) [Articolo su rivista]
Priori, Silvia G; Blomstrom Lundqvist, Carina; Mazzanti, Andrea; Bloma, Nico; Borggrefe, Martin; Camm, John; Elliott, Perry Mark; Fitzsimons, Donna; Hatala, Robert; Hindricks, Gerhard; Kirchhof, Paulus; Kjeldsen, Keld; Kuck, Karl Heinz; Hernandez Madrid, Antonio; Nikolaou, Nikolaos; Norekval, Tone M.; Spaulding, Christian; Van Veldhuisen, Dirk J.; Kolh, Philippe; Lip, Gregory Y. H.; Agewall, Stefan; Barón Esquivias, Gonzalo; Boriani, Giuseppe; Budts, Werner; Bueno, Héctor; Capodanno, Davide; Carerj, Scipione; Crespo Leiro, Maria G.; Czerny, Martin; Deaton, Christi; Dobrev, Dobromir; Erol, Çetin; Galderisi, Maurizio; Gorenek, Bulent; Kriebel, Thomas; Lambiase, Pier; Lancellotti, Patrizio; Lane, Deirdre A.; Lang, Irene; Manolis, Athanasios J.; Morais, Joao; Moreno, Javier; Piepoli, Massimo F.; Rutten, Frans H.; Sredniawa, Beata; Zamorano, Jose Luis; Zannad, Faiez; Aboyans, Victor; Achenbach, Stephan; Badimon, Lina; Baumgartner, Helmut; Bax, Jeroen J.; Dean, Veronica; Fitzsimons, Donna; Gaemperli, Oliver; Kirchhof, Paulus; Nihoyannopoulos, Petros; Ponikowski, Piotr; Roffi, Marco; Torbicki, Adam; Vaz Carneiro, Antonio; Windecker, Stephan; Piruzyan, Armen; Roithinger, Franz Xaver; Mairesse, Georges H.; Goronja, Boris; Shalganov, Tchavdar; Puljević, Davor; Antoniades, Loizos; Kautzner, Josef; Larsen, Jacob Moesgaard; Aboulmaaty, Mervat; Kampus, Priit; Hedman, Antti; Kamcevska Dobrkovic, Lidija; Piot, Olivier; Etsadashvili, Kakhaber; Eckardt, Lars; Deftereos, Spyridon; Gellér, László; Gizurarson, Sigfús; Keane, David; Haim, Moti; Della Bella, Paolo; Abdrakhmanov, Ayan; Mirrakhimov, Aibek; Kalejs, Oskars; Ben Lamin, Hisham; Marinskis, Germanas; Groben, Laurent; Sammut, Mark; Raducan, Aurica; Chaib, Ali; Tande, Pål Morten; Lenarczyk, Radoslaw; Morgado, Francisco Bello; Vatasescu, Radu; Mikhaylov, Evgeny N.; Hlivak, Peter; Arenal, Angel; Jensen Urstad, Mats; Sticherling, Christian; Zeppenfeld, Katja; Chettaoui, Rafik; Demir, Mesut; Duncan, Edward; Parkhomenko, Alexander
abstract

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2015 - 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC) [Articolo su rivista]
Priori, Silvia G; Blomström Lundqvist, Carina; Mazzanti, Andrea; Bloma, Nico; Borggrefe, Martin; Camm, John; Elliott, Perry Mark; Fitzsimons, Donna; Hatala, Robert; Hindricks, Gerhard; Kirchhof, Paulus; Kjeldsen, Keld; Kuck, Karl Heinz; Hernandez Madrid, Antonio; Nikolaou, Nikolaos; Norekvål, Tone M.; Spaulding, Christian; Van Veldhuisen, Dirk J.; Kolh, Philippe; Lip, Gregory Y. H.; Agewall, Stefan; Barón Esquivias, Gonzalo; Boriani, Giuseppe; Budts, Werner; Bueno, Héctor; Capodanno, Davide; Carerj, Scipione; Crespo Leiro, Maria G.; Czerny, Martin; Deaton, Christi; Dobrev, Dobromir; Erol, Çetin; Galderisi, Maurizio; Gorenek, Bulent; Kriebel, Thomas; Lambiase, Pier; Lancellotti, Patrizio; Lane, Deirdre A.; Lang, Irene; Manolis, Athanasios J.; Morais, Joao; Moreno, Javier; Piepoli, Massimo F.; Rutten, Frans H.; Sredniawa, Beata; Zamorano, Jose L.; Zannad, Faiez
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2015 - Against all odds: Targeted pacing site for resynchronization therapy by venoplasty and active fixation lead [Articolo su rivista]
Ziacchi, Matteo; Boriani, Giuseppe; Biffi, Mauro
abstract

In cardiac resynchronization therapy, reaching the target pacing site is essential to achieve optimal therapy. Coronary vein stenosis in the target vein might be an obstacle for lead placement, which can be overcome by venoplasty and stenting of the narrowed segment. Additional active fixation of the left ventricular lead ensures precise location in the target site with minimal risk of lead dislodgment.

2015 - Age-related differences in presentation, treatment, and outcome of patients with atrial fibrillation in Europe: The EORP-AF general pilot registry (EURObservational Research Programme-Atrial Fibrillation) [Articolo su rivista]
Fumagalli, Stefano; Said, Salah A. M.; Laroche, Cecile; Gabbai, Debbie; Marchionni, Niccolò; Boriani, Giuseppe; Maggioni, Aldo P.; Popescu, Mircea Ioachim; Rasmussen, Lars Hvilsted; Crijns, Harry J. G. M.; Lip, Gregory Y. H.
abstract

Objectives This study sought to compare age-related differences in presentation, treatment, and outcome of atrial fibrillation (AF) in a wide cohort of European subjects. Background AF is the most common sustained arrhythmia in the elderly. Methods We evaluated all patients enrolled in the EORP-AF (EURObservational Research Programme-Atrial Fibrillation) General Pilot Registry in 70 centers of 9 European countries. Results Among 3,119 subjects, 1,051 (33.7%) were age ≥75 years. Permanent AF was significantly more common in the elderly, who had a higher prevalence of hypertension, valvular diseases, chronic heart failure, coronary artery disease, renal failure, chronic obstructive pulmonary disease, and prior hemorrhagic event or a transient ischemic attack. Common diagnostic tests were underused in older subjects. Despite their higher stroke risk, the use of oral anticoagulants was significantly lower in the elderly (76.7% vs. 82.8%; p = 0.0012), whereas aspirin and clopidogrel alone or in combination were more often prescribed. Rate control was the management of choice in the older group, with electrical cardioversion and catheter ablation performed less frequently than in the younger age group. Antiarrhythmic drugs were significantly less prescribed in the elderly (29.8% vs. 41.7%; p &lt; 0.0001). At the 1-year follow-up, mortality (11.5% vs. 3.7%; p &lt; 0.0001) and the composite of stroke/transient ischemic attack, systemic thromboembolism, and/or death (13.6% vs. 4.9%; p &lt; 0.0001) were significantly higher in the ≥75 years of age cohort. Conclusions In older patients, AF is more often associated with comorbidities. Rate control is the preferred therapeutic approach. Despite a higher CHA2DS2-VASc score, the use of oral anticoagulation is suboptimal. In elderly subjects, the rate of adverse events is higher at follow-up.

2015 - Antithrombotic management in patients undergoing electrophysiological procedures: a European Heart Rhythm Association (EHRA) position document endorsed by the ESC Working Group Thrombosis, Heart Rhythm Society (HRS), and Asia Pacific Heart Rhythm Society (APHRS) [Articolo su rivista]
Sticherling, Christian; Marin, Francisco; Birnie, David; Boriani, Giuseppe; Calkins, Hugh; Dan, Gheorghe Andrei; Gulizia, Michele; Halvorsen, Sigrun; Hindricks, Gerhard; Kuck, Karl Heinz; Moya, Angel; Potpara, Tatjana; Roldan, Vanessa; Tilz, Roland; Lip, Gregory Y. H.; Gorenek, Bulent; Indik, Julia H.; Kirchhof, Paulus; Ma, Chang Shen; Narasimhan, Calambur; Piccini, Jonathan; Sarkozy, Andrea; Shah, Dipen; Savelieva, Irene
abstract

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2015 - Asymptomatic atrial fibrillation: clinical correlates, management, and outcomes in the EORP-AF Pilot General Registry [Articolo su rivista]
Boriani, Giuseppe; Laroche, C.; Diemberger, I.; Fantecchi, E.; Popescu, M. I.; Rasmussen, L. H.; Sinagra, G.; Petrescu, L.; Tavazzi, L.; Maggioni, A. P.; Lip, G. Y.
abstract

OBJECTIVE: Atrial fibrillation is often asymptomatic, but outcomes require further characterization. The study objective was to investigate the clinical presentation, management, and outcomes in asymptomatic and symptomatic patients with atrial fibrillation who were prospectively enrolled in the EurObservational Research Programme - Atrial Fibrillation (EORP-AF) Pilot General Registry. METHODS: A total of 3119 patients were enrolled, and 1237 (39.7%) were asymptomatic (European Heart Rhythm Association [EHRA] score I). Among symptomatic patients, 963 (51.2%) had mild symptoms (EHRA score II) and 919 (48.8%) had severe or disabling symptoms (EHRA III-IV). Permanent atrial fibrillation was 3-fold more common in asymptomatic patients than in symptomatic patients. RESULTS: On multivariate analysis, male gender (odds ratio [OR], 1.630; 95% confidence interval [CI], 1.384-1.921), older age (OR, 1.019; 95% CI, 1.012-1.026), previous myocardial infarction (OR, 1.681; 95% CI, 1.350-2.093), and limited physical activity (OR, 1.757; 95% CI, 1.495-2.064) were associated significantly with asymptomatic (EHRA I) atrial fibrillation. Fully asymptomatic atrial fibrillation (absence of current and previous symptoms) was present in 520 patients (16.7%) and was associated independently with male gender, age, and previous myocardial infarction. Appropriate guideline-based prescription of oral anticoagulants was lower in these patients, and aspirin was prescribed more frequently. Mortality at 1 year was more than 2-fold higher in asymptomatic patients compared with symptomatic patients (9.4% vs 4.2%, P &lt; .0001) and was associated independently with older age and comorbidities, including chronic kidney disease and chronic heart failure. CONCLUSIONS: Asymptomatic atrial fibrillation is common in daily cardiology practice and is associated with elderly age, more comorbidities, and high thromboembolic risks. A higher 1-year mortality was found in asymptomatic patients compared with symptomatic patients.

2015 - Asymptomatic lone atrial fibrillation - how can we detect the arrhythmia? [Articolo su rivista]
Boriani, Giuseppe; Valzania, Cinzia; Biffi, Mauro; Diemberger, Igor; Ziacchi, Matteo; Martignani, Cristian
abstract

Atrial fibrillation (AF) may occur in the absence of identifiable causes, co-morbidities or structural cardiac disease (lone AF). Silent AF is common and patients may have a completely asymptomatic arrhythmia or may experience both symptomatic and asymptomatic AF episodes. It has been estimated that among patients with recognized AF, one third has no appreciable symptoms. In contemporary clinical practice, AF remains largely underdiagnosed and 25% of patients with AF-associated cardioembolic stroke have not been previously diagnosed with AF. The strategies for AF screening include opportunistic and systematic screening. Several methods for AF detection are nowadays available: from very simple (pulse palpation) to more advanced technologies proposed for ambulatory external monitoring of variable time duration. In patients previously implanted with cardiac electrical devices with an atrial lead, according to current clinical indications, the ability to continuously detect AF and to monitor its evolution is magnified, and AF burden can be precisely measured and monitored along with time. Similar information on AF burden can be also obtained by implantation of subcutaneous cardiac monitors that rely on the analysis of consecutive RR intervals for the diagnosis of AF. The prognosis is generally favorable for patients presenting with lone AF, but adverse outcomes, including stroke and thromboembolic events may occur at long term, in association with aging, or the development of underlying heart disease, or progression from paroxysmal to permanent AF. In this respect, the role of new technologies and diagnostic tools for AF detection and monitoring should be fully defined.

2015 - Cardiac Resynchronization Therapy: An Overview on Guidelines [Articolo su rivista]
Boriani, Giuseppe; Nesti, Martina; Ziacchi, Matteo; Padeletti, Luigi
abstract

Cardiac resynchronization therapy (CRT) is included in international consensus guidelines as a treatment with proven efficacy in well-selected patients on top of optimal medical therapy. Although all the guidelines strongly recommend CRT for LBBB with QRS duration greater than 150 milliseconds, lower strength of recommendation is reported for QRS duration of 120 to 150 milliseconds, especially if not associated with LBBB. CRT is not recommended for a QRS of less than 120 milliseconds. No indication emerges for guiding the implant based on echocardiographic evaluation of dyssynchrony. Many data indicate that CRT is underused and there is heterogeneity in its implementation.

2015 - Cardiac Resynchronization Therapy: State of the Art [Articolo su rivista]
Padeletti, Luigi; Nesti, Martina; Boriani, Giuseppe
abstract

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2015 - Cardiac resynchronization therapy and cardiac sympathetic function [Articolo su rivista]
Martignani, Cristian; Diemberger, Igor; Nanni, Cristina; Biffi, Mauro; Ziacchi, Matteo; Boschi, Stefano; Corzani, Alessandro; Fanti, Stefano; Sambuceti, Gianmario; Boriani, Giuseppe
abstract

Background: Cardiac resynchronization therapy (CRT) is an established therapy for advanced congestive heart failure, improving both survival and hospitalization. The mechanism beneath these improvements still needs to be defined as about one-third of the patients do not benefit from resynchronization. Restoration of sympatho-vagal function can play a significant role in the process, but available data are limited. In this scenario, positron emission tomography scans with 11C-hydroxyephedrine, a noradrenaline analogous, has the potential to characterize the modifications of the sympathetic nervous system induced by CRT in decompensated patients. Materials and methods: Ten patients (six males, age 68 ± 10 years) with primary dilated cardiomyopathy were studied before and after resynchronization (acutely and after 3 months), from a clinical and echocardiographic point of view. Their cardiac sympathetic nerve activity was evaluated by 11C-hydroxyephedrine positron emission tomography before resynchronization, at short and medium term after resynchronization. Results: Responders to CRT (patients showing ≥ 15% decrease in left ventricular end-systolic volume) showed a higher level of left ventricular radiotracer uptake both at baseline and after resynchronization with respect to nonresponders. This was coupled with a progressive improvement in homogeneity in left ventricular tracer uptake mainly in responders. Conclusions: Cardiac resynchronization therapy improves cardiac sympathetic nerve activity in responders since its activation, while nonresponders do not show any significant change at any time of evaluation. CRT seems to be more effective in those patients with a still structurally preserved, yet functionally impaired, neuroautonomic system.

2015 - Cardiac tachyarrhythmias and patient values and preferences for their management: The European Heart Rhythm Association (EHRA) consensus document endorsed by the Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE) [Articolo su rivista]
Lane, Deirdre A; Aguinaga, Luis; Blomström Lundqvist, Carina; Boriani, Giuseppe; Dan, Gheorge Andrei; Hills, Mellanie True; Hylek, Elaine M.; Lahaye, Stephen A.; Lip, Gregory Y. H.; Lobban, Trudie; Mandrola, John; Mccabe, Pamela J.; Pedersen, Susanne S.; Pisters, Ron; Stewart, Simon; Wood, Kathryn; Potpara, Tatjana S.; Gorenek, Bulent; Conti, Jamie Beth; Keegan, Roberto; Power, Suzannah; Hendriks, Jeroen; Ritter, Philippe; Calkins, Hugh; Violi, Francesco; Hurwitz, Jodie
abstract

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2015 - Chronic kidney disease in patients with cardiac rhythm disturbances or implantable electrical devices: Clinical significance and implications for decision making- A position paper of the European Heart Rhythm Association endorsed by the Heart Rhythm Society and the Asia Pacific Heart Rhythm Society [Articolo su rivista]
Boriani, Giuseppe; Savelieva, Irina; Dan, Gheorghe Andrei; Deharo, Jean Claude; Ferro, Charles; Israel, Carsten W.; Lane, Deirdre A.; La Manna, Gaetano; Morton, Joseph; Mitjans, Angel Moya; Vos, Marc A.; Turakhia, Mintu P.; Lip, Gregory Y. H.; Gorenek, Bulent; Takahashi, Yoshihide; Lau, Dennis; Chung, Mina; Nielsen, Jens Cosedis; Fauchier, Laurent; Potpara, Tatjana; Marin, Francisco; Kudaiberdieva, Gulmira; Hindricks, Gerhard; Linde, Cecilia; Brignole, Michele
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2015 - Clinical management of electromagnetic interferences in patients with pacemakers and implantable cardioverter-defibrillators: Review of the literature and focus on magnetic resonance conditional devices [Articolo su rivista]
Corzani, Alessandro; Ziacchi, Matteo; Biffi, Mauro; Allaria, Luca; Diemberger, Igor; Martignani, Cristian; Bratten, Tara; Boriani, Giuseppe; Gardini, Beatrice
abstract

The number of cardiac implantable electronic devices (CIEDs) has greatly increased in the last 10 years. Many electronic devices used in daily activities generate electromagnetic interferences (EMIs) that can interact with CIEDs. In clinical practice, it is very important to know the potential sources of EMIs and their effect on CIEDs in order to understand how to manage or mitigate them. A very important source of EMI is magnetic resonance (MR), which is considered nowadays the diagnostic gold standard for different anatomical districts. In this review, we focused on the effects of EMI on CIEDs and on the clinical management. Moreover, we made a clarification about MR and CIEDs. In patients with CIEDs, EMIs may cause potentially serious and even life-Threatening complications (inappropriate shocks, device malfunctions, inhibition of pacing in pacemaker-dependent patients) and may rarely dictate device replacement. The association of inappropriate shocks with increased mortality highlights the importance of minimizing the occurrence of EMI. Adequate advice andrecommendations about the correct management of EMIs in patients with CIEDs are required to avoid all complications during hospitalization and in daily life. Furthermore, the article focused on actual management about MR and CIEDs.

2015 - Detect Long-term Complications after ICD Replacement (DECODE): Rationale and Study Design of a Multicenter Italian Registry [Articolo su rivista]
Diemberger, Igor; Parisi, Quintino; De Filippo, Paolo; Narducci, Maria Lucia; Zanon, Francesco; Potenza, Domenico Rosario; Ciaramitaro, Gianfranco; Malacrida, Maurizio; Boriani, Giuseppe; Biffi, Mauro
abstract

The replacement of implantable cardioverter-defibrillators (ICDs) may give rise to considerable clinical consequences, the importance of which is underrated by the medical community. Replacement-related adverse events are difficult to identify and require monitoring of both short-term complications and long-term patient outcome. The aim of this study is to perform a structured evaluation of both short- and long-term adverse events and a cost analysis of consecutive ICD replacement procedures. Detect Long-term Complications After ICD Replacement (DECODE) is a prospective, single-arm, multicenter cohort study designed to estimate long-term complication rates (at 12 months and 5 years) in patients undergoing ICD generator replacement. The study will also evaluate predictors of complications, patient management before and during the replacement procedure in clinical practice, and the costs related to use of health care resources. About 800 consecutive patients with standard indications for ICD generator replacement will be enrolled in this study. The decision to undertake generator replacement/upgrade will be made according to the investigators' own judgment (which will be recorded). Patients will be followed for 60 months through periodic in-hospital examinations or remote monitoring. Detailed data on complications related to ICD replacement in current clinical practice are still lacking. The analysis of adverse events will reveal the value of new preventive strategies, thereby yielding both clinical and economic benefits. Moreover, assessment of complication rates after ICD replacement in a real-life setting will help estimate the actual long-term cost of ICD therapy and assess the real impact of increasing ICD longevity on cost-effectiveness.

2015 - Difficult decision making in the management of patients with atrial fibrillation and acute coronary syndrome or invasive cardiovascular interventions: new recommendations for daily practice [Articolo su rivista]
Boriani, Giuseppe; Lane, Deirdre A.; Windecker, Stephan; Huber, Kurt; Kirchhof, Paulus; Lip, Gregory Y. H.
abstract

This editorial refers to 'Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a joint consensus document of the European Society of Cardiology Working Group on Thrombosis, European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS) and Asia-Pacific Heart Rhythm Society (APHRS).' by Lip et al., on page 3155-3179.

2015 - Effects of enhanced pacing modalities on health care resource utilization and costs in bradycardia patients: An analysis of the randomized MINERVA trial [Articolo su rivista]
Boriani, Giuseppe; Manolis, Antonis S.; Tukkie, Raymond; Mont, Lluis; Pürerfellner, Helmut; Santini, Massimo; Inama, Giuseppe; Serra, Paolo; Gulizia, Michele; Samoilenko, Igor Vasilyevich; Wolff, Claudia; Holbrook, Reece; Gavazza, Federica; Padeletti, Luigi
abstract

Background Many patients who suffer from bradycardia and need cardiac pacing also have atrial fibrillation (AF). New pacemaker algorithms, such as atrial preventive pacing and atrial antitachycardia pacing (DDDRP) and managed ventricular pacing (MVP), have been specifically designed to reduce AF occurrence and duration and to minimize the detrimental effects of right ventricular pacing. The randomized MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure trial established that DDDRP + MVP pacing modality reduced permanent AF in bradycardia patients as compared with standard dual-chamber pacing (DDDR). Objective The aim of this study was to estimate the cost savings due to lower AF-related health care utilization events based on health care costs from the United States and the European Union. Methods Dual-chamber pacemaker patients with a history of paroxysmal or persistent AF were randomly assigned to receive DDDR (n = 385) or the advanced features (DDDRP + MVP; n = 383). We used published health care costs from the United States and the European Union (Italy, Spain, and the United Kingdom) to estimate the costs associated with AF-related hospitalizations and emergency visits. Results The rate of AF-related hospitalizations was significantly lower in the DDDRP + MVP group than in the conventional pacemaker group (DDDR group; 42% reduction; incidence rate ratio 0.58). Similarly, a significant reduction of 68% was observed for AF-related emergency department visits (incidence rate ratio 0.32; P <.001). As a consequence, DDDRP + MVP could potentially reduce health care costs by 40%-44%. Over a ten-year period, the cost savings per 100 patients ranged from $35,702 in the United Kingdom to $121,831 in the United States. Conclusion New pacing algorithms such as DDDRP + MVP used in the MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure trial successfully reduced AF-related health care utilization, resulting in significant cost savings to payers.

2015 - European Heart Rhythm Association/Heart Failure Association joint consensus document on arrhythmias in heart failure, endorsed by the Heart Rhythm Society and the Asia Pacific Heart Rhythm Society [Articolo su rivista]
Lip, Gregory Y. H.; Heinzel, Frank R.; Gaita, Fiorenzo; Juanatey, Jose Rámon Gonzalez; Le Heuzey, Jean Yves; Potpara, Tatjana; Svendsen, Jesper Hastrup; Vos, Marc A.; Anker, Stefan D.; Coats, Andrew J.; Haverkamp, Wilhelm; Manolis, Antonis S.; Chung, Mina K.; Sanders, Prashanthan; Pieske, Burkert; Gorenek, Bulent; Lane, Deirdre; Boriani, Giuseppe; Linde, Cecilia; Hindricks, Gerhard; Tsutsui, Hiroyuki; Homma, Shunichi; Brownstein, Sheldon; Nielsen, Jens Cosedis; Lainscak, Mitja; Crespo Leiro, Marisa; Piepoli, Massimo; Seferovic, Petar; Savelieva, Irene
abstract

N/A

2015 - Heart failure in patients with atrial fibrillation in Europe: A report from the EURObservational Research Programme Pilot survey on Atrial Fibrillation [Articolo su rivista]
Lip, Gregory Y. H; Laroche, Cécile; Popescu, Mircea I.; Rasmussen, Lars H.; Vitali Serdoz, Laura; Dan, Gheorghe Andrei; Kalarus, Zbigniew; Crijns, Harry J. G. M.; Oliveira, Mario M.; Tavazzi, Luigi; Maggioni, Aldo P.; Boriani, Giuseppe
abstract

Aims The purpose of this study was too describe the associated baseline features of AF patients with heart failure (HF) with reduced and preserved ejection fraction (HFrEF and HFpEF). Secondly, we assessed symptomatic status and their clinical correlates. Finally, we examined independent predictors for 'heart failure' at the 1-year follow-up period. Methods and results A survey of European cardiologists from nine countries, participating in the EURObservational Research Programme Pilot survey on Atrial Fibrillation (EORP-AF Pilot), was carried out. Of the whole cohort of 2972 patients, 1411 (47.5%) had a diagnosis of HF. Of the AF patients with HF, oral anticoagulants were prescribed to 82.1% and antiarrhythmic drugs in 36.7%. Independent predictors of HFpEF were high body mass index, high heart rate, high systolic blood pressure, low diastolic blood pressure, high CHA2DS2-VASc score, and absence of chronic kidney disease, sleep apnoea, or ischaemic cardiomyopathy. On multivariate stepwise regression analysis, independent predictors of the development of HF were mode of AF presentation, diuretic use, prior HF, COPD, and valvular disease. At 1 year, HF was associated with a greater risk of all-cause mortality (log-rank test, P &lt; 0.001). When HFrEF was compared with HFpEF at 1 year, crude rates were significant for the composite endpoint of 'stroke/thrombo-embolism/transient ischaemic attack and death' (15.9% vs. 11.1%, P = 0.043). Conclusion We provide insights into the clinical characteristics and outcomes in AF patients with HF, who were managed by European cardiologists. Despite a high prevalence of oral anticoagulant use, 1-year mortality and morbidity remained high in AF patients with HF, whether HFrEF or HFpEF. Such patients require a holistic approach to cardiovascular risk management.

2015 - Heterogeneous response of cardiac sympathetic function to cardiac resynchronization therapy in heart failure documented by 11[C]-hydroxy-ephedrine and PET/CT [Articolo su rivista]
Capitanio, Selene; Nanni, Cristina; Marini, Cecilia; Bonfiglioli, Rachele; Martignani, Cristian; Dib, Bassam; Fuccio, Chiara; Boriani, Giuseppe; Picori, Lorena; Boschi, Stefano; Morbelli, Silvia; Fanti, Stefano; Sambuceti, Gianmario
abstract

Introduction: Cardiac resynchronization therapy (CRT) is an accepted treatment in patients with end-stage heart failure. PET permits the absolute quantification of global and regional homogeneity in cardiac sympathetic innervation. We evaluated the variation of cardiac adrenergic activity in patients with idiopathic heart failure (IHF) disease (NYHA III-IV) after CRT using 11C-hydroxyephedrine (HED) PET/CT. Methods: Ten IHF patients (mean age. = 68; range. = 55-81; average left ventricular ejection fraction 26 ± 4%) implanted with a resynchronization device underwent three HED PET/CT studies: PET 1 one week after inactive device implantation; PET 2, one week after PET 1 under stimulated rhythm; PET 3, at 3 months under active CRT. A dedicated software (PMOD 3.4 version) was used to estimate global and regional cardiac uptake of HED through 17 segment polar maps. Results: At baseline, HED uptake was heterogeneously distributed throughout the left ventricle with a variation coefficient of 18 ± 5%. This variable markedly decreased after three months CRT (12 ± 5%, p. &lt;. 0.01). Interestingly, subdividing the 170 myocardial segments (17 segments of each patient multiplied by the number of patients) into two groups, according to the median value of tracer uptake expressed as % of maximal myocardial uptake (76%), we observed a different behaviour depending on baseline innervation: HED uptake significantly increased only in segments with "impaired innervation" (SUV 2.61 ± 0.92 at PET1 and 3.05 ± 1.67 at three months, p. &lt;. 0.01). Conclusion: As shown by HED PET/CT uptake and distribution, improvement in homogeneity of myocardial neuronal function reflected a selective improvement of tracer uptake in regions with more severe neuronal damage. Advances in Knowledge: These finding supported the presence of a myocardial regional variability in response of cardiac sympathetic system to CRT and a systemic response involving remote tissues with rich adrenergic innervation. Implication for patient care: This work might contribute to identify imaging parameters that could predict the response to CRT therapy.

2015 - Holter ECG for pacemaker/defibrillator carriers: What is its role in the era of remote monitoring? [Articolo su rivista]
Diemberger, Igor; Gardini, Beatrice; Martignani, Cristian; Ziacchi, Matteo; Corzani, Alessandro; Biffi, Mauro; Boriani, Giuseppe
abstract

Nowadays several diagnostic tools are available to investigate cardiovascular symptoms like palpitations, dizziness and syncope: ECG Holter (or ambulatory ECG, AECG), external and implantable event/loop recorders. Despite this technological burden, many diagnoses are still missed. In the meantime, we are facing an increasing use of implantable devices for cardiac pacing/defibrillation (CIED), which have rapidly evolved from simple pacing/shock boxes to devices including several diagnostic features. However, these functions are not adequately exploited in current clinical practice and several redundant diagnostic tests, like AECG, are still prescribed to CIED carriers, leading to an increase of costs and a delay in final diagnosis. This review is aimed at identifying the current role of AECG in CIED carriers in view of this technological improvement. First, we will briefly present the indications for AECG according to current guidelines. We will then provide a direct comparison of the different diagnostic features provided by AECG (and event/loop recorders) versus automatic diagnostic CIED to highlight the respective pros and cons. This will serve to carefully discuss these indications in view of the results of recent studies on CIED carriers, highlighting the need for proper implantation and follow-up. Eventually, we will provide useful hints to properly analyse AECG in CIED carriers, considering the different behaviours according to the implemented algorithms. We will conclude by suggesting updated indications for AECG.

2015 - Improved outcomes with European Society of Cardiology guideline-adherent antithrombotic treatment in high-risk patients with atrial fibrillation: A report from the EORP-AF General Pilot Registry [Articolo su rivista]
Lip, Gregory Y. H.; Laroche, Cécile; Popescu, Mircea Iaochim; Rasmussen, Lars Hvilsted; Vitali Serdoz, Laura; Dan, Gheorghe Andrei; Kalarus, Zbigniew; Crijns, Harry J. G. M.; Oliveira, Mario Martins; Tavazzi, Luigi; Maggioni, Aldo P.; Boriani, Giuseppe
abstract

Aims Guideline-adherent therapy for stroke prevention in atrial fibrillation has been associated with better outcomes, in terms of thromboembolism (TE) and bleeding. Methods and results In this report from the EuroObservational Research Programme-Atrial Fibrillation (EORP-AF) Pilot General Registry, we describe the associated baseline features of 'high risk' AF patients in relation to guideline-adherent antithrombotic treatment, i.e. whether they were adherent, over-treated, or under-treated based on the 2012 European Society of Cardiology (ESC) guidelines. Secondly, we assessed the predictors of guideline-adherent antithrombotic treatment. Thirdly, we evaluated outcomes for all-cause mortality, TE, bleeding, and the composite endpoint of 'any TE, cardiovascular death or bleeding' in relation to whether they were ESC guideline-adherent treatment. From the EORP-AF cohort, the follow-up dataset of 2634 subjects was used to assess the impact of guideline adherence or non-adherence. Of these, 1602 (60.6%) were guideline adherent, whilst 458 (17.3%) were under-treated, and 574 (21.7%) were over-treated. Non-guideline-adherent treatment can be related to region of Europe as well as associated clinical features, but not age, AF type, symptoms, or echocardiography indices. Over-treatment per se was associated with symptoms, using the EHRA score, as well as other comorbidities. Guideline-adherent antithrombotic management based on the ESC guidelines is associated with significantly better outcomes. Specifically, the endpoint of 'all cause death and any TE' is increased by &gt;60% by undertreatment [hazard ratio (HR) 1.679 (95% confidence interval (CI) 1.202-2.347)] or over-treatment [HR 1.622 (95% CI 1.173-2.23)]. For the composite endpoint of 'cardiovascular death, any TE or bleeding', over-treatment increased risk by &gt;70% [HR 1.722 (95% CI 1.200-2.470)]. Conclusion Even in this cohort with high overall rates of oral anticoagulation use, ESC guideline-adherent antithrombotic management is associated with significantly better outcomes, including those related to mortality and TE, as well as the composite endpoint of 'cardiovascular death, any TE or bleeding'. These contemporary observations emphasize the importance of guideline implementation, and adherence to the 2012 ESC guidelines for stroke prevention in AF.

2015 - Inappropriate shock for myopotential over-sensing in a patient with subcutaneous ICD [Articolo su rivista]
Corzani, Alessandro; Ziacchi, Matteo; Biffi, Mauro; Diemberger, Igor; Martignani, Cristian; Boriani, Giuseppe
abstract

Inappropriate ICD shocks are common adverse events; they are mainly due to supraventricular arrhythmias and secondly are related to noise, undersensing, oversensing, device malfunctions. We present a case of inappropriate device therapy due to myopotential oversensing in a patient with a subcutaneous ICD (s-ICD). A 58 years old male with an s-ICD during the device interrogation showed a previous episode of suspected sustained ventricular tachycardia at 210 bpm, which was effectively treated with ICD shock. The patient experienced the electrical shock while holding a big gas-cylinder in his arms. The EGM analysis revealed many irregular ventricular signals of low amplitude lasting for 24 s and interrupted by the shock. The device showed no malfunctions. This is the first case report of inappropriate S-ICD shock related to myopotential over-sensing. By recording intracardiac EGM, we demonstrated that the noise was created by the activity of the pectorals muscles.

2015 - Management of atrial fibrillation in bradyarrhythmias [Articolo su rivista]
Boriani, Giuseppe; Padeletti, Luigi
abstract

Sinus node disease (SND), a common indication to implant a pacemaker, is frequently associated with atrial fibrillation (AF), either at implantation (paroxysmal AF) or during follow-up, which often evolves to persistent or permanent AF. Pacemakers with an atrial lead allow continuous monitoring of the atrial rhythm and enable detection of the burden of AF. Asymptomatic atrial tachyarrhythmias, being associated with increased risk of stroke, have important prognostic implications, and their detection could guide decision-making about antithrombotic prophylaxis. Pacing mode and pacing algorithms can influence the occurrence of AF and atrial tachyarrhythmias. In DDD/DDDR pacing mode, reduction of unnecessary right ventricular pacing positively affects the occurrence and evolution of AF, but patients with a history of atrial tachyarrhythmias maintain an increased risk of arrhythmic events. In the MINERVA study, the use of algorithms that act in the atrium for preventive pacing and atrial antitachycardia pacing while minimizing right ventricular pacing was beneficial in patients with SND and previous atrial tachyarrhythmias, and was associated with a significant reduction in evolution to permanent AF. New information available on therapies delivered at the atrial level by implanted devices suggests clinical advantages that could improve current guidelines for the management of AF and atrial tachyarrhythmias.

2015 - New left ventricular active fixation lead: The experience of lead extraction [Articolo su rivista]
Ziacchi, Matteo; Diemberger, Igor; Martignani, Cristian; Boriani, Giuseppe; Biffi, Mauro
abstract

Left ventricular active fixation lead is fundamental for targeted pacing site. The challenge is the extraction but in our experience Attain® Stability™ was removed without any problem. As usual the lead can cause a thrombosis of the coronary vein but we performed a venoplasty in order to place again a lead in the target site and maintain the CRT response.

2015 - New-generation atrial antitachycardia pacing (Reactive ATP) is associated with reduced risk of persistent or permanent atrial fibrillation in patients with bradycardia: Results from the MINERVA randomized multicenter international trial [Articolo su rivista]
Padeletti, Luigi; Pürerfellner, Helmut; Mont, Lluis; Tukkie, Raymond; Manolis, Antonis S.; Ricci, Renato; Inama, Giuseppe; Serra, Paolo; Scheffer, Mike G.; Martins, Vitor; Warman, Eduardo N.; Vimercati, Marco; Grammatico, Andrea; Boriani, Giuseppe
abstract

Background Atrial fibrillation (AF) is a frequent comorbidity in patients with pacemaker and is a recognized cause of mortality, morbidity, and quality-of-life impairment. The international MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure trial established that atrial preventive pacing and atrial antitachycardia pacing (DDDRP) in combination with managed ventricular pacing (MVP) reduce permanent AF occurrence in comparison with standard dual-chamber pacing (DDDR). Objective We aimed to determine the role of new-generation atrial antitachycardia pacing (Reactive ATP) in preventing AF disease progression. Methods Patients with dual-chamber pacemaker and with previous atrial tachyarrhythmias were randomly assigned to DDDR (n = 385 (33%)), MVP (n = 398 (34%)), or DDDRP+MVP (n = 383 (33%)) group. The incidence of permanent AF, as defined by the study investigator, or persistent AF, defined as ≥7 consecutive days with AF, was estimated using the Kaplan-Meier method, while its association with patients' characteristics was evaluated via multivariable Cox regression. Results At 2 years, the incidence of permanent or persistent AF was 26% (95% confidence interval [CI] 22%-31%) in the DDDR group, 25% (95% CI 21%-30%) in the MVP group, and 15% (95% CI 12%-20%) in the DDDRP+MVP group (P &lt;.001 vs DDDR; P =.002 vs MVP). Generalized estimating equation-adjusted Reactive ATP efficacy was 44.4% (95% CI 41.3%-47.6%). Multivariate modeling identified high Reactive ATP efficacy (&gt;44.4%) as a significant predictor of reduced permanent or persistent AF risk (hazard ratio 0.32; 95% CI 0.13-0.781; P =.012) and episodes' characteristics, such as long atrial arrhythmia cycle length, regularity, and the number of rhythm transitions, as predictors of high ATP efficacy. Conclusion In patients with bradycardia, DDDRP+MVP delays AF disease progression, with Reactive ATP efficacy being an independent predictor of permanent or persistent AF reduction.

2015 - Non-valvular atrial fibrillation: Potential clinical implications of the heterogeneous definitions used in trials on new oral anticoagulants [Articolo su rivista]
Boriani, Giuseppe; Cimaglia, Paolo; Fantecchi, Elisa; Mantovani, Valentina; Ziacchi, Matteo; Valzania, Cinzia; Martignani, Cristian; Biffi, Mauro; Diemberger, Igor
abstract

Aims: To evaluate the potential impact of the different definitions of non-valvular atrial fibrillation reported in the literature and to analyse the possible implications for eligibility for novel oral anticoagulants (NOACs) in clinical practice. Methods: We derived the definitions of 'non-valvular atrial fibrillation' from the exclusion criteria of the trials on NOACs, and then assessed the number and percentage of patients fulfilling the various definitions in a cohort of 500 consecutive atrial fibrillation patients, undergoing clinical and echocardiographic evaluation in our cardiology department, as either in-patients or out-patients. Results: Among the 500 atrial fibrillation patients (mean age 71.27±12.6 years), with permanent atrial fibrillation in 45.2% of the cases, hypertension was very common, either as the main diagnosis or as an associated disease. Valvular heart disease as the main diagnosis (including valvular prosthesis) accounted for 22.8% of the cases. At the echocardiographic evaluation, valvular alterations were very common, especially mitral regurgitation (present, with a variable degree of severity in 63.6% of the cases). Application of the RE-LY exclusion criteria with regard to valvular disease resulted in 116 (23.2%) patients of our cohort classified as valvular atrial fibrillation. This percentage was reduced to 12.2 and 8.8% if ROCKET-AF and ARISTOTLE/ENGAGE-AF criteria, respectively, were applied. Conclusions: Non-valvular atrial fibrillation is a common clinical entity, but without a unified definition in the literature. The impact in daily practice of the different definitions adopted in trials is noteworthy, since in one patient out of seven, the eligibility for NOACs can be questioned, simply as a consequence of adopting a more or less restrictive definition.

2015 - Ranolazine in the treatment of atrial fibrillation: Results of the dose-ranging RAFFAELLO (Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion) study [Articolo su rivista]
De Ferrari, Gaetano M.; Maier, Lars S.; Mont, Lluís; Schwartz, Peter J.; Simonis, Gregor; Leschke, Matthias; Gronda, Edoardo; Boriani, Giuseppe; Darius, Harald; Guillamón Torán, Laura; Savelieva, Irene; Dusi, Veronica; Marchionni, Niccolò; Quintana Rendón, Miguel; Schumacher, Kai; Tonini, Giulia; Melani, Lorenzo; Giannelli, Stefano; Alberto Maggi, Carlo; John Camm, A.
abstract

Background Currently available antiarrhythmic agents for the treatment of atrial fibrillation (AF) have important limitations, leaving an unmet need for safe and effective therapy. Ranolazine is an approved antianginal agent with a favorable safety profile and electrophysiologic properties suggesting a potential role in the treatment of AF. Objective The purpose of this study was to assess the safety and efficacy of ranolazine in the prevention of AF recurrence after successful electrical cardioversion and to ascertain the most appropriate dose of this agent. Methods This prospective, multicenter, randomized, double-blind, placebo-control parallel group phase II dose-ranging trial randomized patients with persistent AF (7 days to 6 months) 2 hours after successful electrical cardioversion to placebo, or ranolazine 375 mg, 500 mg, or 750 mg bid. Patients were monitored daily by transtelephonic ECG. The primary end-point was the time to first AF recurrence. Results Of 241 patients randomized, 238 took at least 1 drug dose. Ranolazine proved to be safe and tolerable. No dose of the drug significantly prolonged time to AF recurrence. AF recurred in 56.4%, 56.9%, 41.7%, and 39.7% of patients in the placebo, ranolazine 375 mg, ranolazine 500 mg, and ranolazine 750 mg groups, respectively. The reduction in overall AF recurrence in the combined 500-mg and 750-mg groups was of borderline significance compared to the placebo group (P =.053) and significant compared to 375-mg group (P =.035). Conclusion No dose of ranolazine significantly prolonged time to AF recurrence. However, the 500-mg and 750 mg-groups combined reduced AF recurrences, suggesting a possible role for this agent in the treatment of AF.

2015 - Remote monitoring of cardiac implantable electrical devices in Europe: Quo vadis? [Articolo su rivista]
Boriani, Giuseppe
abstract

This editorial refers to 'Implementation and reimbursement of remote monitoring for cardiac implantable electronic devices in Europe: a survey from the Health Economics Committee of the European Heart Rhythm Association' by G.H. Mairesse et al., on page 814-818.

2015 - Repolarization effects of multiple-cycle chemotherapy and predictors of QTc prolongation: A prospective female cohort study on >2000 ECGs [Articolo su rivista]
Diemberger, Igor; Massaro, Giulia; Cubelli, Marta; Rubino, Daniela; Quercia, Sara; Martignani, Cristian; Ziacchi, Matteo; Biffi, Mauro; Bernardi, Alessandra; Cacciari, Nicoletta; Zamagni, Claudio; Boriani, Giuseppe
abstract

Purpose: Oncological patients are at increasing risk of QT prolongation, a risk factor for ventricular arrhythmia. We assessed impact and risk factors for corrected QT (QTc) prolongation during multiple-cycle chemotherapy. Methods: We enrolled 100 outpatients initiating chemotherapy in a university center specializing in female cancer. Clinical, drug, laboratory, and 12-lead ECG data collection at baseline and at each chemotherapy cycle was performed. Results: Enrolled patients were followed for 992 chemotherapy cycles (median 7; interquartile range 6-13); 2438 ECGs were recorded (20; 18-31) 36.8 % pre-therapy, 36.8 % following chemotherapy, and 22.5 % 7-10 days after chemotherapy. Maximum QTc (Max-QTc) was recorded after 4 chemotherapy administrations in >50 % of the entire cohort and also within every subset of patients with prolonged QTc (57 % 471-480 ms; 54 % 481-500 ms; 66 % >500 ms). No cumulative effect on QTc was shown. QTc prolongation was comparable among the various protocols. Prophylactic/supportive drugs were not associated with additional QTc prolongation. Variables independently associated with QTc prolongation >470 ms were age (OR 1.056 95 % CI 1.006-1.108, p∈=∈0.028) and the baseline-first chemotherapy averaged QTc (BC-QTc) (OR 1.092 95 % CI 1.051-1.136), a novel parameter devised for this study. Only BC-QTc maintained significance for QTc >480 ms. BC-QTc >435 ms identified 100 % of patients with Max-QTc >500 ms, 96 % with Max-QTc 481-500 ms, and 66 % with Max-QTc 471-480 ms. Only 29 % of patients with Max-QTc 470 ms presented a BC-QTc >435 ms. Conclusions: Our results confirm the high prevalence of QTc prolongation after chemotherapy. Most of the patients reached Max-QTc after several cycles. BC-QTc may help in stratifying arrhythmic risk in real-world clinical practice.

2015 - The epidemiologic threat of atrial fibrillation: Need for secondary, primary, and primordial prevention [Articolo su rivista]
Boriani, Giuseppe
abstract

N/A

2015 - Triple antithrombotic therapy in atrial fibrillation patients with acute coronary syndromes or undergoing percutaneous coronary intervention or transcatheter aortic valve replacement [Articolo su rivista]
Capodanno, Davide; Lip, Gregory Y. H.; Windecker, Stephan; Huber, Kurt; Kirchhof, Paulus; Boriani, Giuseppe; Lane, Deirdre; Gilard, Martine; Collet, Jean Philippe; Valgimigli, Marco; Byrne, Robert A.
abstract

N/A

2015 - Validation of a simple risk stratification tool for patients implanted with Cardiac Resynchronization Therapy: The VALID-CRT risk score [Articolo su rivista]
Gasparini, Maurizio; Klersy, Catherine; Leclercq, Cristophe; Lunati, Maurizio; Landolina, Maurizio; Auricchio, Angelo; Santini, Massimo; Boriani, Giuseppe; Proclemer, Alessandro; Leyva, Francisco
abstract

Aims Mortality after cardiac resynchronization therapy (CRT) is difficult to predict. We sought to design and validate a simple prognostic score for patients implanted with CRT, based on readily available clinical variables, including age, gender, left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) class, presence/absence of atrial fibrillation, presence/absence of atrioventricular junction ablation, coronary heart disease, diabetes, and implantation of a CRT device with defibrillation. Methods For predictive modelling, 5153 consecutive patients enrolled in 72 European centres (79% male; LVEF 25.9 ± 6.85%; NYHA class III-IV 77.5%; QRS 158.4 ± 32.3 ms) were randomly split into derivation (70%) and validation (30%) samples. The primary endpoint was total mortality and the secondary endpoint was cardiovascular mortality. The final predictive model fit was assessed by plotting observed vs. predicted survival. Results In the entire cohort, 1004 deaths occurred over a follow-up of 14 409 person years. Total mortality ranged from 3.1% to 28.2% at 2 years in the first and fifth quintile of the risk score, respectively. At 5 years, total mortality was 10.3%, 18.6%, 27.6%, 36.1%, and 58.8%, from the first to the fifth quintile. Compared with the lowest quintile (Q), total mortality was significantly higher in the other four quintiles [Q2 hazard ratio (HR) = 1.71; Q3 HR = 2.20; Q4 HR = 4.03; Q5 HR = 8.03; all P &lt; 0.001). The final model, which was based on the entire cohort using the above variables, showed a good discrimination (Harrell's c = 0.70) and high explained variation (0.26). The mean predicted survival fitted well with the observed survival for up to 6 years of follow-up. Conclusions The VALID-CRT risk score, which is based on routine, readily available clinical variables, reliably predicted the long-term total and cardiovascular mortality in patients undergoing CRT. While this score cannot be used to predict the benefit of CRT, it may be useful for predicting survival after CRT. This may have useful implications for follow-up.

2015 - Wytyczne ESC dotyczące postępowania u pacjentów z komorowymi zaburzeniami rytmu oraz zapobiegania nagłym zgonom sercowym w 2015 roku [Articolo su rivista]
Priori, S. G.; Blomstrom-Lundqvist, C.; Mazzanti, A.; Blom, N.; Borggrefe, M.; Camm, J.; Elliott, P. M.; Fitzsimons, D.; Hatala, R.; Hindricks, G.; Kirchhof, P.; Kjeldsen, K.; Kuck, K. -H.; Hernandez-Madrid, A.; Nikolaou, N.; Norekva, T. M.; Spaulding, C.; Van Veldhuisen, D. J.; Kolh, P.; Lip, G. Y. H.; Agewall, S.; Baron-Esquivias, G.; Boriani, G.; Budts, W.; Bueno, H.; Capodanno, D.; Carerj, S.; Crespo-Leiro, M. G.; Czerny, M.; Deaton, C.; Dobrev, D.; Erol, C.; Galderisi, M.; Gorenek, B.; Kriebel, T.; Lambiase, P.; Lancellotti, P.; Lane, D. A.; Lang, I.; Manolis, A. J.; Morais, J.; Moreno, J.; Piepoli, M. F.; Rutten, F. H.; Sredniawa, B.; Zamorano, J. L.; Zannad, F.
abstract

2014 - 'Real-World' antithrombotic treatment in atrial fibrillation: The eorp-af pilot survey [Articolo su rivista]
Lip, Gregory Y. H; Laroche, Cécile; Dan, Gheorghe Andrei; Santini, Massimo; Kalarus, Zbigniew; Rasmussen, Lars Hvilsted; Ioachim, Popescu Mircea; Tica, Otilia; Boriani, Giuseppe; Cimaglia, Paolo; Diemberger, Igor; Hellum, Camilla Fragtrup; Mortensen, Bettina; Maggioni, Aldo P.
abstract

Background Current guidelines strongly recommend that oral anticoagulation should be offered to patients with atrial fibrillation and ≥1 stroke risk factors. The guidelines also recommend that oral anticoagulation still should be used in the presence of stroke risk factors irrespective of rate or rhythm control. Methods In an analysis from the dataset of the EURObservational Research Programme on Atrial Fibrillation Pilot Survey (n = 3119), we examined antithrombotic therapy prescribing, with particular focus on the risk factors determining oral anticoagulation or antiplatelet therapy use. Results When oral anticoagulation was used among admitted patients in whom no pharmacologic cardioversion, electrical cardioversion, or catheter ablation was performed or planned, vitamin K antagonist therapy was prescribed in the majority (72.2%), whereas novel oral anticoagulants were used in the minority (7.7%). There was no significant difference in bleeding risk factors among the patients treated with the different types of antithrombotic therapies, except for those with chronic kidney disease, in whom oral anticoagulation was less commonly used (P =.0318). Antiplatelet therapy was more commonly used in patients with a high Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly (&gt;65 years), Drugs/alcohol concomitantly score (≥2) (P &lt;.0001). More oral anticoagulation use was associated with female gender (P =.0245). Less novel oral anticoagulant use was associated with valvular heart disease (P &lt;.0001), chronic heart failure (P =.0010), coronary artery disease (P &lt;.0001), and peripheral artery disease (P =.0092). Coronary artery disease was the strongest reason for combination therapy with oral anticoagulation plus antiplatelet drug (odds ratio, 8.54; P &lt;.0001). When the Congestive heart failure, Hypertension, Age ≥75 [Doubled], Diabetes, Stroke [Doubled]-Vascular disease, Age 65-74, and Sex category [female] score was used, 95.6% of patients with a score ≥1 received antithrombotic therapy, with 80.5% of patients with a score ≥1 receiving oral anticoagulation. Of note, 83.7% of those with a score ≥2 received antithrombotic therapy. Of the latter, 70.9% of those with a score ≥2 received oral anticoagulation, vitamin K antagonists were used in 64.1%, and novel oral anticoagulants were used in 6.9%. Conclusions The EURObservational Research Programme on Atrial Fibrillation Pilot Survey provides contemporary data on oral anticoagulation prescribing by European cardiologists for atrial fibrillation. Although the uptake of oral anticoagulation (mostly vitamin K antagonist therapy) has improved since the Euro Heart Survey a decade ago, antiplatelet therapy is still commonly prescribed, with or without oral anticoagulation, whereas elderly patients are commonly undertreated with oral anticoagulation.

2014 - 11C-mHED for PET / CT: principles of synthesis, methodology and first clinical applications [Articolo su rivista]
Bonfiglioli, Rachele; Nanni, Cristina; Martignani, Cristian; Zanoni, Lucia; La Donna, Raffaele; Diemberger, Igor; Boriani, Giuseppe; Pettinato, Cinzia; Sambuceti, Gianmario; Fanti, Stefano; Mansi, Luigi
abstract

Alterations of the cardiac autonomic nervous system play an important role in the pathway of many heart diseases. Nuclear imaging tools have been demonstrated to be useful for global and regional assessment of myocardial innervation. We used (11)C-meta-hydroxy-ephedrine ((11)C-mHED), a catecholamine analogue, as a radiotracer usable with a PET/CT scanner to study the cardiac sympathetic system. After a fast and automatic synthesis of mHED and its labeling with (11)C, we acquired cardiac images by using a PET/ CT scanner. In this paper we present our preliminary results showing the radiotracer bio-distribution in humans 10 minutes post injection. The present study assesses the feasibility of PET/CT with the radiolabeled catecholamine analogue ((11)C-mHED) in order to determine sympathetic innervation in the human heart.

2014 - 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy [Articolo su rivista]
Brignole, Michele; Auricchio, Angelo; Baron Esquivias, Gonzalo; Bordachar, Pierre; Boriani, Giuseppe; Breithardt, Ole A; Cleland, John; Deharo, Jean Claude; Delgado, Victoria; Elliott, Perry M; Gorenek, Bulent; Israel, Carsten W; Leclercq, Christophe; Linde, Cecilia; Mont, Lluís; Padeletti, Luigi; Sutton, Richard; Vardas, Panos E.
abstract

N/A

2014 - A prospective survey in European Society of Cardiology member countries of atrial fibrillation management: baseline results of EURObservational Research Programme Atrial Fibrillation (EORP-AF) Pilot General Registry [Articolo su rivista]
Lip, G. Y. H.; Laroche, C.; Dan, G. -A.; Santini, M.; Kalarus, Z.; Rasmussen, L. H.; Oliveira, M. M.; Mairesse, G.; Crijns, H. J. G. M.; Simantirakis, E.; Atar, D.; Kirchhof, P.; Vardas, P.; Tavazzi, L.; Maggioni, A. P.; Raepers, M.; El Husseini, Z.; Dilling-Boer, D.; Schurmans, J.; Vijgen, J.; Koopman, P.; Huybrechts, W.; Dormal, F.; Blommaert, D.; Deceuninck, O.; Xhaet, O.; Fragtrup Hellum, C.; Mortensen, B.; Ginnerup Sorensen, B.; Joensen, A. M.; Rasmussen, L. H.; Karlsdottir, A.; Pehrson, S.; Hummelshoj, J.; Svenningsen, A-M.; Tanggaard, L.; Wiggers, P.; Nygaard, A.; Jonstrup, A.; Petersen, J.; Odgaard, A.; Mortensen, M.; Frost, L.; Svenstrup Moller, D.; Sondergaard, H. M.; Christensen, P. D.; Xydonas, S.; Lioni, L.; Dimopoulou, M.; Georgiopoulos, G.; Papatheodorou, E.; Boutas, P.; Kartalis, A.; Vardas, P.; Nakou, H.; Kanoupakis, E.; Simantirakis, E.; Tahmatzidis, D.; Styliadis, I.; Vassilikos, V.; Koskinas, K.; Fragakis, N.; Polymeropoulos, K.; Maligos, G.; Martignani, C.; Diemberger, I.; Boriani, G.; Frisoni, J.; Biffi, M.; Ziacchi, M.; Cimaglia, P.; Fantecchi, E.; Boni, S.; Gabbai, D.; Marchionni, N.; Fumagalli, S.; Bobbo, M.; Ramani, F.; Sinagra, G.; Vitali-Serdoz, L.; Nordio, A.; Porto, A.; Zecchin, M.; Di Nora, C.; Novo, S.; Guarneri, F. P.; Macaione, F.; Rod, R.; Stodle, R. M. O.; Pervez, M. O.; Smith, P.; Buvarp, M.; Ronnevik, P. K.; Vold, A.; Fuglestved, J.; Atar, D.; Stenshjemmet, E.; Risberg, K.; Sokal, A.; Kubicius, A.; Prochniewicz, E.; Pokrywa, K.; Rzeuski, R.; Weryszko, A.; Haberka, M.; Gasior, Z.; Slowikowski, A.; Janion, M.; Kolodziej, M.; Janion-Sadowska, A.; Drozdz, J.; Stasiak, M.; Jakubowski, P.; Ciurus, T.; Pawlak, M.; Nowakowska, M.; Wiklo, K.; Kurpesa, M.; Olejnik, A.; Miarka, J.; Streb, W.; Zielinski, L.; Dluzniewski, M.; Tomaszewska-Kiecana, M.; Opolski, G.; Budnik, M.; Kiliszek, M.; Gorska, J.; Mamcarz, A.; Sliz, D.; Makowiecki, K.; Fuglewicz, A.; Drozd, M.; Garncarek, M.; Musialik-Lydka, A.; Markowicz-Pawlus, E.; Kazmierczak, G.; Leopold-Jadczyk, A.; Koziel, M.; Kalarus, Z.; Sobral, S.; Pereira, H.; Brandao Alves, L.; Ribeiro, L.; Miranda, R.; Almeida, S.; Madeira, F.; Faustino, M.; Oliveira, R.; Gil, V.; Braga, C.; Martins, J.; Rocha, S.; Magalhaes, S.; Ramos, V.; Bernardo, R.; Costa, F.; Morgado, F.; Galvao Santos, P.; Almeida, N.; Adragao, P.; Carmo, P.; Mariano Pego, G.; Ferreira, J.; Elvas, L.; Ventura, M.; Antonio, N.; Ferreira, R.; Damasio, A. F.; Santos, A. R.; Picarra, B.; Neves, D.; De Jesus, I.; Amado, J.; Sousa, P.; Candeias, R.; Lourenco, A.; Pereira, A.; Canario-Almeida, F.; Fernandes, M.; Ferreira, F.; Machado, I.; Quelhas, I.; Guardado, J.; Pereira, V.; Cavaco, D.; Almeida, N.; Adragao, P.; Carmo, P.; Lousinha, A.; Valente, B.; Silva, N.; Cunha, P.; Pimenta, R.; Santos, S.; Martins Oliveira, M.; Vicente, S.; Bernardes, A.; Nunes Diogo, A.; Rodrigues, E.; Frazao Rodrigues De Sousa, J. M.; Carpinteiro, L.; Satendra, M.; Cortez Dias, N.; Neto, S.; Gama Ribeiro, V.; Goncalves, H.; Primo, J.; Adao, L.; Oliveira, M.; Costa, A.; Delgado, A.; Marmelo, B.; Moreira, D.; Santos, J.; Santos, L.; Rodrigues, B.; Pop Moldovan, A.; Darabantiu, D.; Todea, B.; Pop, C.; Dicu, D.; Filip, D.; Mercea, D.; Kozma, G.; Schiopu, M.; Catanescu, G.; Popescu, C.; Bobescu, E.; Gabor, A.; Buzea, A.; Dan, A.; Buzea Daha, I.; Asan, N.; Popescu, R.; Dan, G. -A.; Bartos, D.; Badila, E.; Tintea, E.; Grigore, C.; Daraban, A. M.; Sandulescu, A.; Carp, A.; Gherasim, D.; Stoian, I. M.; Baluta, M. M.; Vintila, M. M.; Popescu, M. I.; Tica, O.; Petrescu, L.; Alina-Ramona, N.; Dan, R.; Cozma, D. C.; Tutuianu, C.; Mangea, M.; Goanta, E.; Van Opstal, J. M.; Van Rennes, R.; Mulder, B. A.; Said, S. A. M.; Folkeringa, R. J.; Philippens, S.; Crijns, H. J. G. M.; Blaauw, Y.; Aksoy, I.; Pluymen, M.; Driessen, R.; Limantoro, I.; Lankveld, T.; Mafi Rad, M.; Hendriks, J.; Van Unen, W. H.; Meeder, J.
abstract

Aims: Given the advances in atrial fibrillation (AF) management and the availability of new European Society of Cardiology (ESC) guidelines, there is a need for the systematic collection of contemporary data regarding the management and treatment of AF in ESC member countries. Methods and results: We conducted a registry of consecutive in- and outpatients with AF presenting to cardiologists in nine participating ESC countries. All patients with an ECG-documented diagnosis of AF confirmed in the year prior to enrolment were eligible. We enroled a total of 3119 patients from February 2012 to March 2013, with full data on clinical subtype available for 3049 patients (40.4% female; mean age 68.8 years). Common comorbidities were hypertension, coronary disease, and heart failure. Lone AF was present in only 3.9% (122 patients). Asymptomatic AF was common, particularly among those with permanent AF. Amiodarone was the most common antiarrhythmic agent used (~20%), while beta-blockers and digoxin were the most used rate control drugs. Oral anticoagulants (OACs) were used in 80% overall, most often vitamin K antagonists (71.6%), with novel OACs being used in 8.4%. Other antithrombotics (mostly antiplatelet therapy, especially aspirin) were still used in one-third of the patients, and no antithrombotic treatment in only 4.8%. Oral anticoagulants were used in 56.4% of CHA 2DS2-VASc = 0, with 26.3% having no antithrombotic therapy. A high HAS-BLED score was not used to exclude OAC use, but there was a trend towards more aspirin use in the presence of a high HAS-BLED score. Conclusion: The EURObservational Research Programme Atrial Fibrillation (EORP-AF) Pilot Registry has provided systematic collection of contemporary data regarding the management and treatment of AF by cardiologists in ESC member countries. Oral anticoagulant use has increased, but novel OAC use was still low. Compliance with the treatment guidelines for patients with the lowest and higher stroke risk scores remains suboptimal. © The Author 2013.

2014 - AF burden is important - Fact or fiction? [Articolo su rivista]
Boriani, Giuseppe; Diemberger, I.; Ziacchi, M.; Valzania, C.; Gardini, B.; Cimaglia, P.; Martignani, C.; Biffi, M.
abstract

Asymptomatic atrial fibrillation (AF) is common and in view of its prognostic impact (the same as of clinically overt AF) knowledge of the overall AF burden (defined as the amount of time spent in AF) appears to be important, both for scientific and clinical reasons. Data collected on more than 12,000 patients indicate that cardiac implantable electrical devices (CIEDs) are validated tools for measuring AF burden and that AF burden is associated with an increased risk of stroke. A maximum daily AF burden of ≥ 1 h carries important negative prognostic implications and may be a clinically relevant parameter for improving risk stratification for stroke. Decision-making should primarily consider the context in which asymptomatic, subclinical arrhythmias are detected (i.e. primary or secondary prevention of stroke and systemic embolism) and the risk profile of every individual patient with regard to thromboembolic and haemorrhagic risk, as well as patient preferences and values. Continuous monitoring using CIEDs with extensive data storage capabilities allow in-depth study of the temporal relationship between AF and ischaemic stroke. The relationships between AF and stroke are complex. AF is certainly a risk factor for cardioembolic stroke, with a cause-effect relationship between the arrhythmia and a thromboembolic event, the latter being related to atrial thrombi. However, AF can also be a simple 'marker of risk', with a non-causal association between the arrhythmia and stroke, the latter being possibly related to atheroemboli from the aorta, the carotid arteries or from other sources. © 2014 John Wiley &amp; Sons Ltd.

2014 - Atrial antitachycardia pacing and managed ventricular pacing in bradycardia patients with paroxysmal or persistent atrial tachyarrhythmias: The MINERVA randomized multicentre international trial [Articolo su rivista]
Boriani, Giuseppe; Tukkie, R; Manolis, As; Mont, L; Pürerfellner, H; Santini, M; Inama, G; Serra, P; de Sousa, J; Botto, Gl; Mangoni, L; Grammatico, A; Padeletti, L.
abstract

AIMS: Atrial fibrillation (AF) is a common comorbidity in bradycardia patients. Advanced pacemakers feature atrial preventive pacing and atrial antitachycardia pacing (DDDRP) and managed ventricular pacing (MVP), which minimizes unnecessary right ventricular pacing. We evaluated whether DDDRP and MVP might reduce mortality, morbidity, or progression to permanent AF when compared with standard dual-chamber pacing (Control DDDR). METHODS AND RESULTS: In a randomized, parallel, single-blind, multi-centre trial we enrolled 1300 patients with bradycardia and previous atrial tachyarrhythmias, in whom a DDDRP pacemaker had recently been implanted. History of permanent AF and third-degree atrioventricular block were exclusion criteria. After a 1-month run-in period, 1166 eligible patients, aged 74 ± 9 years, 50% females, were randomized to Control DDDR, DDDRP + MVP, or MVP. Analysis was intention-to-treat. The primary outcome, i.e. the 2-year incidence of a combined endpoint composed of death, cardiovascular hospitalizations, or permanent AF, occurred in 102/385 (26.5%) Control DDDR patients, in 76/383 (19.8%) DDDRP + MVP patients [hazard ratio (HR) = 0.74, 95% confidence interval 0.55-0.99, P = 0.04 vs. Control DDDR] and in 85/398 (21.4%) MVP patients (HR = 0.89, 95% confidence interval 0.77-1.03, P = 0.125 vs. Control DDDR). When compared with Control DDDR, DDDRP + MVP reduced the risk for AF longer than 1 day (HR = 0.66, 95% CI 0.52-0.85, P < 0.001), AF longer than 7 days (HR = 0.52, 95% CI 0.36-0.73, P < 0.001), and permanent AF (HR = 0.39, 95% CI 0.21-0.75, P = 0.004). CONCLUSION: In patients with bradycardia and atrial tachyarrhythmias, DDDRP + MVP is superior to standard dual-chamber pacing. The primary endpoint was significantly lowered through the reduction of the progression of atrial tachyarrhythmias to permanent AF.

2014 - Cardiac arrhythmias in acute coronary syndromes: Position paper from the joint EHRA, ACCA, and EAPCI task force [Articolo su rivista]
Gorenek, Bulent; Lundqvist, Carina Blomström; Terradellas, Josep Brugada; Camm, A. John; Hindricks, Gerhard; Huber, Kurt; Kirchhof, Paulus; Kuck, Karl-Heinz; Kudaiberdieva, Gulmira; Lin, Tina; Raviele, Antonio; Santini, Massimo; Tilz, Roland Richard; Valgimigli, Marco; Vos, Marc A.; Vrints, Christian; Zeymer, Uwe; Boriani, Giuseppe
abstract

N/A

2014 - Cardiac resynchronization therapy: Implant rates, temporal trends and relationships with heart failure epidemiology [Articolo su rivista]
Boriani, Giuseppe; Berti, Elena; Belotti, Laura Maria Beatrice; Biffi, Mauro; Carboni, Angelo; Bandini, Alberto; Casali, Edoardo; Tomasi, Corrado; Toselli, Tiziano; Baraldi, Paolo; Bottoni, Nicola; Barbato, Gaetano; Sassone, Biagio
abstract

BACKGROUND: Consensus guidelines define indications for cardiac resynchronization therapy (CRT), but the variability in implant rates in 'real world' clinical practice, as well as the relationship with the epidemiology of heart failure are not defined. METHODS AND RESULTS: In Emilia-Romagna, an Italian region with around 4.4 million inhabitants, a registry was instituted to collect data on implanted devices for CRT, with (CRT-D) or without defibrillation (CRT-P) capabilities. Data from all consecutive patients resident in this region who underwent a first implant of a CRT device in years 2006-2010 were collected and standardized (considering each of the nine provinces of the region). The number of CRT implants increased progressively, with a 71% increase in 2010 compared to 2006. Between 84 and 90% of implants were with CRT-D devices. The variability in standardized implant rates among the provinces was substantial and the ratio between the provinces with the highest and the lowest implant rates was always greater than 2. Considering prevalent cases of heart failure in the period 2006-2010, the proportion of patients implanted with CRT per year ranged between 0.23 and 0.30%. CONCLUSIONS: The application in 'real world' clinical practice of CRT in heart failure is quite heterogeneous, with substantial variability even among areas belonging to the same region, with the need to make the access to this treatment more equitable. Despite the increased use of CRT, its overall rate of adoption is low, if a population of prevalent heart failure patients is selected on the basis of administrative data on hospitalizations. © 2014 Italian Federation of Cardiology.

2014 - Cardiac resynchronization therapy: The conundrum of predicting response in the individual patient [Articolo su rivista]
Boriani, Giuseppe; Ziacchi, M.; Diemberger, M.; Valzania, C.; Biffi, M.; Martignani, C.
abstract

N/A

2014 - Cost-effectiveness of implantable cardioverter-defibrillator in today's world [Articolo su rivista]
Boriani, Giuseppe; Cimaglia, Paolo; Biffi, Mauro; Martignani, Cristian; Ziacchi, Matteo; Valzania, Cinzia; Diemberger, Igor
abstract

The implantable cardioverter-defibrillator (ICD) is an example of an effective intervention with high up-front costs and delayed benefits. It has become a proven and well-accepted therapy not only for secondary but also for primary prevention of sudden cardiac death in patients with ischemic and non-ischemic heart disease. In recent years, the international guidelines have extended the indications to the prophylactic ICD, increasing the number of eligible patients and, together, the financial challenges of a widespread implementation. In this article, we review the available economic tools that can help address the ICD cost issue. We think that the awareness of such knowledge may facilitate dialogues between physicians, administrators and policy-makers, and help foster rational decision making. © 2014, Cardiological Society of India. All rights reserved.

2014 - Determinants of all-cause mortality in different age groups in patients with severe systolic left ventricular dysfunction receiving an implantable cardioverter defibrillator (from the Italian ClinicalService Multicenter Observational Project) [Articolo su rivista]
Fumagalli, Stefano; Gasparini, Maurizio; Landolina, Maurizio; Lunati, Maurizio; Boriani, Giuseppe; Proclemer, Alessandro; Santini, Massimo; Mangoni, Lorenza; Padeletti, Margherita; Marchionni, Niccolò; Padeletti, Luigi
abstract

Heart failure (HF) is a common condition in elderly patients. Despite great improvements in medical therapy, HF mortality remains high. Implantable cardioverter defibrillator (ICD) significantly lengthens the survival rate of subjects with severe HF, but little evidence exists on its effect in elderly persons. Aim of this study was to compare the age-related determinants of prognosis in a large population of patients with ICD. We divided all patients who underwent an ICD implantation in 117 Italian centers of the "ClinicalService Project" into 3 age groups (<65, 65 to 74, ≥75 years), and collected clinical and instrumental variables at baseline and during follow-up (median length: 27 months). Between 2004 and 2011, 6,311 patients were enrolled (5,174 men; left ventricular ejection fraction 29% ± 9%); 1,510 subjects were ≥75 years (23.9%; mean age 78 ± 3 years). The prevalence of co-morbidities increased with age. HF was most frequently due to coronary artery disease in the elderly, who also showed the worst New York Heart Association class. At multivariate analysis, older age, coronary artery disease, chronic obstructive pulmonary disease, chronic renal failure, diabetes, complex ventricular arrhythmias, and left ventricular ejection fraction were significant predictors of all-cause mortality. After adjustment, the hazard ratioage group for mortality was 22.6% less than at univariate analysis. When groups were analyzed separately, age alone predicted mortality in the oldest. In conclusion, a large proportion of our population was aged ≥75 years. Mortality was related to age and several co-morbidities, except for the oldest patients in whom age alone resulted predictive. © 2014 Elsevier Inc. All rights reserved.

2014 - Device-detected atrial fibrillation and risk for stroke: An analysis of >10 000 patients from the SOS AF project (Stroke preventiOn Strategies based on Atrial Fibrillation information from implanted devices) [Articolo su rivista]
Boriani, Giuseppe; Glotzer, Taya V.; Santini, Massimo; West, Teena M.; De Melis, Mirko; Sepsi, Milan; Gasparini, Maurizio; Lewalter, Thorsten; Camm, John A.; Singer, Daniel E.
abstract

Objective The aim of this study was to assess the association between maximum daily atrial fibrillation (AF) burden and risk of ischaemic stroke. Background Cardiac implanted electronic devices (CIEDs) enhance detection of AF, providing a comprehensive measure of AF burden. Design, setting, and patients A pooled analysis of individual patient data from five prospective studies was performed. Patients without permanent AF, previously implanted with CIEDs, were included if they had at least 3 months of follow-up. A total of 10 016 patients (median age 70 years) met these criteria. The risk of ischaemic stroke associated with pre-specified cut-off points of AF burden (5 min, 1, 6, 12, and 23 h, respectively) was assessed. Results During a median follow-up of 24 months, 43% of 10 016 patients experienced at least 1 day with at least 5 min of AF burden and for them the median time to the maximum AF burden was 6 months (inter-quartile range: 1.3–14). A Cox regression analysis adjusted for the CHADS2 score and anticoagulants at baseline demonstrated that AF burden was an independent predictor of ischaemic stroke. Among the thresholds of AF burden that we evaluated, 1 h was associated with the highest hazard ratio (HR) for ischaemic stroke, i.e. 2.11 (95% CI: 1.22–3.64, P = 0.008). Conclusions Device-detected AF burden is associated with an increased risk of ischaemic stroke in a relatively unselected population of CIEDs patients. This finding may add to the basis for timely and clinically appropriate decision-making on anticoagulation treatment.

2014 - Ghidul societăţii Europene de cardiologie pentru cardiostimulare şi terapie de resincronizare cardiacă (2013) [Articolo su rivista]
Brignole, M.; Auricchio, A.; Baron-Esquivias, G.; Bordachar, P.; Boriani, G.; Breithardt, O. A.; Cleland, J.; Deharo, J. C.; Delgado, V.; Elliott, P. M.; Gorenek, B.; Israel, C. W.; Leclercq, C.; Linde, C.; Mont, L.; Padeletti, L.; Sutton, R.; Vardas, P. E.; Zamorano, J. L.; Achenbach, S.; Baumgartner, H.; Bax, J. J.; Bueno, H.; Dean, V.; Deaton, C.; Erol, C.; Fagard, R.; Ferrari, R.; Hasdaii, D.; Hoes, A. W.; Kirchhof, P.; Knuut, J.; Kol, P.; Lancellotti, P.; Linhart, A.; Nihoyannopoulos, P.; Piepoli, M. F.; Ponikowskii, P.; Sirnes, P. A.; Tamargo, J. L.; Tendera, M.; Torbicki, A.; Wijns, W.; Windecker, S.
abstract

2014 - Guía de práctica clínica de la ESC 2013 sobre estimulación cardiaca y terapia de resincronización cardiaca [Articolo su rivista]
Brignole, Michele; Auricchio, Angelo; Barón Esquivias, Gonzalo; Bordachar, Pierre; Boriani, Giuseppe; Breithardt, Ole A.; Cleland, John; Deharo, Jean Claude; Delgado, Victoria; Elliott, Perry M.; Gorenek, Bulent; Israel, Carsten W.; Leclercq, Christophe; Linde, Cecilia; Mont, Lluís; Padeletti, Luigi; Sutton, Richard; Vardas, Panos E.
abstract

N/A

2014 - Left ventricular lead stabilization to retain cardiac resynchronization therapy at long term: When is it advisable? [Articolo su rivista]
Biffi, Mauro; Bertini, Matteo; Ziacchi, Matteo; Diemberger, Igor; Martignani, Cristian; Boriani, Giuseppe
abstract

AimsLeft ventricular (LV) lead dislodgement occurs in about 10.6% of patients in the first 12 months after cardiac resynchronization therapy defibrillator implantation, and causes lack of clinical improvement, repeated surgery, and predisposes to infective complications and death. To understand the factors predictive of lead dislodgement, and to investigate whether bipolar LV lead stabilization can reduce the dislodgement rate and improve the clinical outcome.Methods and resultsPredisposing coronary vein anatomy was identified on a retrospective series of 218 patients implanted before August 2009. Lead stabilization guided by vein anatomy was prospectively tested on consecutive patients from October 2009 to December 2010. Among 84 patients, lead stabilization based on vein anatomy was recommended in 19 patients, of which 16 agreed and 3 refused. Two of these latter had lead dislodgement within 1 month, whereas none of the former had adverse events during 23.8 ± 3.1 months follow-up. Only 1 of 58 patients deemed at low risk had lead dislodgement. Seven patients required lead stabilization for severe phrenic stimulation issues that dictated lead placement at specific sites. Patients with stabilized LV leads were more likely to be cardiac resynchronization therapy (CRT) responders than the others: 19 of 26 (73%) vs. 34 of 58 (59%, P= NS), and had a significantly higher proportion of super-responders: 12 of 26 (46%) vs. 12 of 58 (21%, P< 0.005).ConclusionCoronary vein anatomy may assist decision making about the need for LV lead stabilization, and the choice of tools during the implanting procedure to ensure effective CRT delivery at long term. © The Author 2013.

2014 - Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: A joint consensus document of the European Society of Cardiology Working Group on Thrombosis, European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS) and Asia-Pacific Heart Rhythm Society (APHRS) [Articolo su rivista]
Lip, Gy; Windecker, S; Huber, K; Kirchhof, P; Marin, F; Ten Berg, Jm; Haeusler, Kg; Boriani, Giuseppe; Capodanno, D; Gilard, M; Zeymer, U; Lane, D; Document, Reviewers; Storey, Rf; Bueno, H; Collet, Jp; Fauchier, L; Halvorsen, S; Lettino, M; Morais, J; Mueller, C; Potpara, Ts; Rasmussen, Lh; Rubboli, A; Tamargo, J; Valgimigli, M; Zamorano, Jl
abstract

N.A.

2014 - New devices in heart failure: An European Heart Rhythm Association report [Articolo su rivista]
Kuck, Karl Heinz; Bordachar, Pierre; Borggrefe, Martin; Boriani, Giuseppe; Burri, Haran; Leyva, Francisco; Schauerte, Patrick; Theuns, Dominic; Thibault, Bernard; Kirchhof, Paulus; Hasenfuss, Gerhard; Dickstein, Kenneth; Leclercq, Christophe; Linde, Cecilia; Tavazzi, Luigi; Ruschitzka, Frank
abstract

Several new devices for the treatment of heart failure (HF) patients have been introduced and are increasingly used in clinical practice or are under clinical evaluation in either observational and/or randomized clinical trials. These devices include cardiac contractility modulation, spinal cord stimulation, carotid sinus nerve stimulation, cervical vagal stimulation, intracardiac atrioventricular nodal vagal stimulation, and implantable hemodynamic monitoring devices. This task force believes that an overview on these technologies is important. Special focus is given to patients with HF New York Heart Association Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex. An overview on potential device options in addition to optimal medical therapy will be helpful for all physicians treating HF patients. © 2013 The Author.

2014 - Pacing-induced torsades de pointes after the short-long-short sequence in a patient with a biventricular defibrillator: What is the mechanism? [Articolo su rivista]
De Maria, Elia; Biffi, Mauro; Cappelli, Stefano; Boriani, Giuseppe
abstract

N/A

2014 - Prevention of infections in cardiovascular implantable electronic devices beyond the antibiotic agent [Articolo su rivista]
De Maria, Elia; Diemberger, Igor; Vassallo, Pier L.; Pastore, Monica; Giannotti, Federica; Ronconi, Cinzia; Romandini, Andrea; Biffi, Mauro; Martignani, Cristian; Ziacchi, Matteo; Bonfatti, Federica; Tumietto, Fabio; Viale, Pierluigi; Boriani, Giuseppe
abstract

The increase in incidence/prevalence of infections of implantable pacemakers and defibrillators (implantable cardioverter defibrillator, ICD) is outweighing that of the implanting procedures, mainly favored by the changes in patient profile. Despite the high impact on patient's outcome and related costs for healthcare systems, we lack specific evidence on the preventive measures with the exception of antibiotic prophylaxis. The aim of this study is to focus on common approaches to pacemaker/ICD implantation to identify the practical preventive strategies and choices that can (potentially) impact on the occurrence of this feared complication. After a brief introduction on clinical presentation, pathogenesis, and risk factors, we will present the results from a survey on the preventive strategies adopted by different operators from the 25 centers of the Emilia Romagna region in the northern Italy (4.4 million inhabitants). These data will provide the basis for reviewing available literature on this topic and identifying the gray areas. The last part of the article will cover the available evidence about pacemaker/ICD implantation, focusing on prophylaxis of pacemaker/ICD infection as a 'continuum' starting before the surgical procedure (from indications to patient preparation), which follows during (operator, room, and techniques) and after the procedure (patient and device follow-up). We will conclude by evaluating the relationship between adherence to the available evidence and the volume of procedures of the implanting centers or operators' experience according to the results of our survey. © 2014 Italian Federation of Cardiology.

2014 - Prognosis and treatment of atrial fibrillation patients by European cardiologists: One Year Follow-up of the EURObservational Research Programme-Atrial Fibrillation General Registry Pilot Phase (EORP-AF Pilot registry) [Articolo su rivista]
Lip, Gy; Laroche, C; Ioachim, Pm; Rasmussen, Lh; Vitali Serdoz, L; Petrescu, L; Darabantiu, D; Crijns, Hj; Kirchhof, P; Vardas, P; Tavazzi, L; Maggioni, Ap; Boriani, Giuseppe
abstract

BACKGROUND: The EURObservational Research Programme-Atrial Fibrillation General Registry Pilot Phase (EORP-AF Pilot) provides systematic collection of contemporary data regarding the management and treatment of 3119 subjects with AF from 9 member European Society of Cardiology (ESC) countries. In this analysis, we report the development of symptoms, use of antithrombotic therapy and rate vs. rhythm strategies, as well as determinants of mortality and/or stroke/transient ischaemic attack (TIA)/peripheral embolism during 1-year follow-up in this contemporary European registry of AF patients. METHODS: The registry population comprised consecutive in- and out-patients with AF presenting to cardiologists in participating ESC countries. Consecutive patients with AF documented by ECG were enrolled. Follow-up was performed by the local investigator, initially at 1 year, as part of a long-term cohort study. RESULTS: At the follow-up, patients were frequently asymptomatic (76.8%), but symptoms are nevertheless common among paroxysmal and persistent AF patients, especially palpitations, fatigue, and shortness of breath. Oral anticoagulant (OAC) use remains high, ∼78% overall at follow-up, and of those on vitamin K antagonist (VKA), 84% remained on VKA during the follow-up, while of those on non-VKA oral anticoagulant (NOAC) at baseline, 86% remained on NOAC, and 11.8% had changed to a VKA and 1.1% to antiplatelet therapy. Digitalis was commonly used in paroxysmal AF patients. Of rhythm control interventions, electrical cardioversion was performed in 9.7%, pharmacological cardioversion in 5.1%, and catheter ablation in 4.4%. Despite good adherence to anticoagulation, 1-year mortality was high (5.7%), with most deaths were cardiovascular (70%). Hospital readmissions were common, especially for atrial tachyarrhythmias and heart failure. On multivariate analysis, independent baseline predictors for mortality and/or stroke/TIA/peripheral embolism were age, AF as primary presentation, previous TIA, chronic kidney disease, chronic heart failure, malignancy, and minor bleeding. Independent predictors of mortality were age, chronic kidney disease, AF as primary presentation, prior TIA, chronic obstructive pulmonary disease, malignancy, minor bleeding, and diuretic use. Statin use was predictive of lower mortality. CONCLUSION: In this 1-year follow-up analysis of the EORP-AF pilot general registry, we provide data on the first contemporary registry focused on management practices among European cardiologists, conducted since the publication of the new ESC guidelines. Overall OAC use remains high, although persistence with therapy may be problematic. Nonetheless, continued OAC use was more common than in prior reports. Despite the high prescription of OAC, 1-year mortality and morbidity remain high in AF patients, particularly from heart failure and hospitalizations.

2014 - Regional differences in presentation and treatment of patients with atrial fibrillation in Europe: A report from the EURObservational Research Programme Atrial Fibrillation (EORP-AF) Pilot General Registry [Articolo su rivista]
Lip, Gy; Laroche, C; Boriani, Giuseppe; Dan, Ga; Santini, M; Kalarus, Z; Rasmussen, Lh; Oliveira, Mm; Mairesse, G; Crijns, Hj; Simantirakis, E; Atar, D; Maggioni, Ap; Tavazzi, L.
abstract

AIMS: Country differences in management practices are evident, and the publication of management guidelines by the European Society of Cardiology (ESC) and other learned societies has tried to recommend a uniform evidence-based approach to management. Despite the availability of guidelines and efforts to improve implementation, differences in guideline adherence are evident, and differences between countries and regions within Europe are therefore likely. METHODS AND RESULTS: In this analysis from the baseline dataset of the EORP-AF Pilot survey, we examined regional differences in presentation and treatment of contemporary patients with atrial fibrillation (AF) in Europe, as managed by European cardiologists. We focused on a subgroup of 902 hospital admitted patients in whom no rhythm control was performed or planned. Chronic heart failure was more common in East countries (P < 0.0001) while hypertension and peripheral artery disease were more common in South countries (both P < 0.0001). Previous bleeding and chronic kidney disease were more common in South countries (both P < 0.0001). A CHA2DS2-VASc score of ≥2 was highest in East and South countries (93.0 and 95.3%, respectively) compared with 80.8% in West countries (P < 0.0001). A HAS-BLED score of ≥3 was also highest in East and South countries (18.0 and 29.2% respectively) compared with 4.8% in West countries (P < 0.0001). Oral anticoagulation (OAC) use (either as OAC or OAC plus antiplatelet therapy) in West, East, and South countries was 72.0, 74.7, and 76.2%, respectively. Only antiplatelet therapy was used in 13.6, 15.4, and 12.4%, respectively. An initial rate control strategy only was most common in South countries (77.8%) (P < 0.0001). CONCLUSION: From the systematic collection of contemporary data regarding the management and treatment of AF in nine participating member ESC countries, we provide hypothesis-generating insights into regional management practices in Europe with regard to patient characteristics and treatment options.

2014 - Role of 18F-FDG PET/CT in the diagnosis of infective endocarditis in patients with an implanted cardiac device: A prospective study [Articolo su rivista]
Graziosi, Maddalena; Nanni, Cristina; Lorenzini, Massimiliano; Diemberger, Igor; Bonfiglioli, Rachele; Pasquale, Ferdinando; Ziacchi, Matteo; Biffi, Mauro; Martignani, Cristian; Bartoletti, Michele; Tumietto, Fabio; Boriani, Giuseppe; Viale, Pier Luigi; Fanti, Stefano; Rapezzi, Claudio
abstract

Purpose: Infective endocarditis (IE) is widely underdiagnosed or diagnosed after a major delay. The diagnosis is currently based on the modified DUKE criteria, where the only validated imaging technique is echocardiography, and remains challenging especially in patients with an implantable cardiac device. The aim of this study was to assess the incremental diagnostic role of 18F-FDG PET/CT in patients with an implanted cardiac device and suspected IE. Methods: We prospectively analysed 27 consecutive patients with an implantable device evaluated for suspected device-related IE between January 2011 and June 2013. The diagnostic probability of IE was defined at presentation according to the modified DUKE criteria. PET/CT was performed as soon as possible following the clinical suspicion of IE. Patients then underwent medical or surgical treatment based on the overall clinical evaluation. During follow-up, we considered: lead cultures in patients who underwent extraction, direct inspection and lead cultures in those who underwent surgery, and a clinical/instrumental reevaluation after at least 6 months in patients who received antimicrobial treatment or had an alternative diagnosis and were not treated for IE. After the follow-up period, the diagnosis was systematically reviewed by the multidisciplinary team using the modified DUKE criteria and considering the new findings. Results: Among the ten patients with a positive PET/CT scan, seven received a final diagnosis of "definite IE", one of "possible IE" and two of "IE rejected". Among the 17 patients with a negative PET/CT scan, four were false-negative and received a final diagnosis of definite IE. These patients underwent PET/CT after having started antibiotic therapy (≥48 h) or had a technically suboptimal examination. Conclusion: In patients with a cardiac device, PET/CT increases the diagnostic accuracy of the modified Duke criteria for IE, particularly in the subset of patients with possible IE in whom it may help the clinician manage a challenging situation. © 2014 Springer-Verlag.

2014 - Sex-related differences in presentation, treatment, and outcome of patients with atrial fibrillation in Europe: A report from the Euro Observational Research Programme Pilot survey on Atrial Fibrillation [Articolo su rivista]
Lip, Gregory Y. H; Laroche, Cecile; Boriani, Giuseppe; Cimaglia, Paolo; Dan, Gheorghe Andrei; Santini, Massimo; Kalarus, Zbigniew; Rasmussen, Lars Hvilsted; Popescu, Mircea Ioachim; Tica, Otilia; Hellum, Camilla Fragtrup; Mortensen, Bettina; Tavazzi, Luigi; Maggioni, Aldo P.
abstract

Aims Sex differences in the epidemiology and clinical management of AF are evident. Of note, females are more symptomatic and if age &gt;65, are at higher risk of thromboembolism if incident AF develops, compared with males. Methods and results In an analysis from the dataset of the Euro Observational Research Programme on Atrial Fibrillation (EORP-AF) Pilot survey (n = 3119), we examined sex-related differences in presentation, treatment, and outcome of contemporary patients with AF in Europe.Female subjects were older (P &lt; 0.0001), with a greater proportion aged ≥75 years, with more heart failure and hypertension. Heart failure with preserved ejection fraction was more common in females (P &lt; 0.0001), as was valvular heart disease (P = 0.0003). Females were more symptomatic compared with males with a higher proportion being EHRA Class III and IV (P = 0.0012). The more common symptoms that were more prevalent in females were palpitations (P &lt; 0.0001) and fear/anxiety (P = 0.0007). Other symptoms (e.g. dyspnoea, chest pain, fatigue, etc.) were not different between males and females. Health status scores were significantly lower for females overall, specifically for the psychological and physical domains (both P &lt; 0.0001) but not for the sexual activity domain (P = 0.9023). Females were less likely to have electrical cardioversion (18.9 vs. 25.5%, P &lt; 0.0001), and more likely to receive rate control (P = 0.002). Among patients recruited in hospital and discharged alive (n = 2009), documented contraindications to vitamin K antagonist (VKA) were evident in 23.8% of females. A CHA2DS2-VASc score ≥2 was found in 94.7% of females and 74.6% of males (P &lt; 0.0001), with oral anticoagulants being used in 95.3 and 76.2%, respectively (P &lt; 0.0001). A HAS-BLED score of ≥3 was found in 12.2% of females and 14.5% of males. Independent predictors of VKA use in females on multivariate analysis were CHA2DS2-VASc score (P = 0.0007), lower HAS-BLED score (P = 0.0284), and prosthetic mechanical valves (P = 0.0276). Conclusion The EORP-AF Pilot survey provides contemporary data on sex differences in clinical features and management of AF patients participating in the EORP-AF Pilot registry. Female subjects were older and more symptomatic, compared with males, and were more likely to receive rate control. Also, female patients were at higher stroke risk overall, but oral anticoagulation was used in a high proportion of patients.

2014 - Statistics on the use of cardiac electronic devices and electrophysiological procedures in 55 ESC countries: 2013 report from the European Heart Rhythm Association (EHRA) [Articolo su rivista]
Arribas, Fernando; Auricchio, Angelo; Boriani, Giuseppe; Brugada, Josep; Deharo, Jean Claud; Hindriks, Gerhardt; Kuck, Karl Heinz; Merino, Jose Luis; Vardas, Panos; Wolpert, Christian; Zeppenfeld, Katja
abstract

N/A

2014 - Stroke/thromboembolism and intracranial hemorrhage in a real-world atrial fibrillation population: The Complications of Atrial Fibrillation in the Bologna Area (CAFBO) study [Articolo su rivista]
Palareti, Gualtiero; Salomone, Luisa; Cavazza, Mario; Guidi, Marcello; Muscari, Antonio; Boriani, Giuseppe; Di Micoli, Antonio; Guizzardi, Giordano; Procaccianti, Gaetano; Guidetti, Angelo; Binetti, Nicola; Malservisi, Simona; Masina, Marco; Viola, Antonella; Bua, Vincenzo; Ongari, Maurizio; Diaspri, Giampaolo; Lip, Gregory Y. H.
abstract

BACKGROUND: Ischemic events (IEs) and intracranial hemorrhages (ICHs) are feared complications of atrial fibrillation (AF) and of antithrombotic treatment in patients with these conditions.METHODS: Patients with AF admitted to the EDs of the Bologna, Italy, area with acute IE or ICH were prospectively recorded over 6 months.RESULTS: A total of 178 patients (60 male patients; median age: 85 years) presented with acute IE. Antithrombotic therapy was as follows: (1) vitamin K antagonists (VKAs) in 31 patients (17.4%), with international normalized ratio (INR) at admission of, 2.0 in 16 patients, 2.0 to 3.0 in 13 patients, and . 3.0 in two patients; (2) aspirin (acetylsalicylic acid) (ASA) in 107 patients (60.1%); and (3) no treatment in 40 patients (22.5%), mainly because AF was not diagnosed. Twenty patients (eight male patients; median age: 82 years) presented with acute ICH: 13 (65%) received VKAs (INR, 2.0-3.0 in 11 patients and . 3.0 in two patients), while six (30%) received ASA. Most IEs (88%) and ICHs (95%) occurred in patients aged . 70 years. A modeling analysis of patients aged . 70 years was used to estimate annual incidence in subjects anticoagulated with VKAs in our Network of Anticoagulation Centers (NACs), or those expected to have AF but not included in NACs. The expected incidence of IE was 12.0%/y (95% CI, 10.7-13.3) in non-NACs and 0.57%/y (95% CI, 0.42-0.76) in NACs (absolute risk reduction [ARR], 11.4%/y; relative risk reduction [RRR], 95%; P , .0001). The incidence of ICH was 0.63%/y (95% CI, 0.34-1.04) and 0.30%/y (95% CI, 0.19-0.44), respectively (ARR, 0.33%/y; RRR, 52.4%/y; P 5 .04).CONCLUSIONS: IEs occurred mainly in elderly patients who received ASA or no treatment. One-half of patients with IEs receiving anticoagulant treatment had subtherapeutic INRs. Therapeutic approaches to elderly subjects with AF require an effective anticoagulant treatment strategy.

2014 - The OPTI-MIND study: A prospective, observational study of pacemaker patients according to pacing modality and primary indications [Articolo su rivista]
Biffi, Mauro; Melissano, Donato; Rossi, Paolo; Kaliska, Gabriela; Havlíĉek, Aleš; Pelargonio, Gemma; Romero, Rafael; Guastaferro, Ciro; Menichelli, Maurizio; Vireca, Elisa; Frisoni, Jessica; Boriani, Giuseppe; Malacký, Tibor
abstract

Aims The OPTI-MIND study aims to collect 2-year clinical outcomes of pacemaker patients in real-world clinical practice, overall and according to patient characteristics and pacemaker settings. Methods and results The present analysis of the OPTI-MIND study describes the programmed device settings after discharge from the pacemaker implant. The objective was to determine whether these settings fit recent guidelines for device-programmed physiological pacing based on the preservation of atrioventricular synchrony, avoiding unnecessary pacing, ensuring rate increase during exercise or preventing neurally mediated symptoms. A total of 1740 patients were enroled at 68 centres worldwide. Baseline patient characteristics and device programming settings are available in 1674 of 1740 patients (96%). Guidelines to ensure physiological pacing were followed in 41% of patients: in patients with sinus node disease (SND), and without atrioventricular block (AVB), device programming could have led to unnecessary right ventricular pacing in 38% of patients. In SND patients with chronotropic incompetence, assisted rate increase during exercise was not programmed in 42% of patients. In 11% of patients with AVB, atrioventricular (AV) synchrony was not pursued; the main drivers being advanced age and history of atrial fibrillation. Patients with both SND and AVB were generally programmed physiologically (87%). Conclusion The present analysis showed that frequent deviations occurred when comparing the device settings at discharge from the pacemaker implant in clinical practice to the available guidelines on pacing mode selection. Analysis of 2-year outcomes in the OPTI-MIND study will provide an insight into whether specific physiological settings could improve the quality of pacing with a positive effect on patient outcome. © 2014 Published on behalf of the European Society of Cardiology. All rights reserved.

2014 - Ventricular rate monitoring as a tool to predict and prevent atrial fibrillation-related inappropriate shocks in heart failure patients treated with cardiac resynchronisation therapy defibrillators [Articolo su rivista]
Ricci, Renato Pietro; Pignalberi, Carlo; Landolina, Maurizio; Santini, Massimo; Lunati, Maurizio; Boriani, Giuseppe; Proclemer, Alessandro; Facchin, Domenico; Catanzariti, Domenico; Morani, Giovanni; Gulizia, Michele; Mangoni, Lorenza; Grammatico, Andrea; Gasparini, Maurizio
abstract

Objective: Inappropriate implantable cardioverter defibrillators (ICD) therapies have been associated with multiple adverse effects, including worse quality of life and prognosis. We evaluated the possibility of predicting atrial fibrillation (AF)-related inappropriate ICD shocks through continuous monitoring of device diagnostics. Methods: 1404 ICD patients were prospectively followed in an observational research by 74 Italian cardiology centres. Device diagnostics stored daily information on AF duration and ventricular rate (VR) during AF. Uncontrolled VR was defined as mean VR>80 beats per minute (bpm) and maximum VR>110 bpm. Expert electrophysiologists reviewed the ventricular tachycardia/ventricular fibrillation (VT/VF) episodes electrograms, stored in the device memory, and classified appropriate detections, inappropriate detection mechanisms and ICD therapy outcomes. Results: Over a median follow-up of 31 months, 511 (36%) patients suffered spontaneous VT/VF, which were treated by ICD shocks in a subgroup of 189 (13%) patients. Inappropriate detections occurred in 232 (16%) patients, and inappropriate ICD shocks in 101 (7%) patients. AF was the cause of inappropriate shocks in 60 patients. AF caused 144 inappropriate shocks: 53% of all inappropriate shocks. The likelihood of experiencing AF-related inappropriate shocks was 2.4% at 1 year and 6% at 5 years. Uncontrolled VR during AF proved to be an independent predictor of AF-related inappropriate shocks (OR=3.02, p=0.006); an alarm set at a VR>90 bpm or 100 bpm was associated with prediction of AF-related inappropriate shocks with a sensitivity of 73% or 62%, respectively. Conclusions: AF is the most common cause of inappropriate shocks in ICD patients. Continuous remote monitoring of VR during AF would promptly and efficiently predict AF-related inappropriate shocks.

2013 - 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy [Articolo su rivista]
M., Brignole; A., Auricchio; G., Baron Esquivias; P., Bordachar; Boriani, Giuseppe; O. A., Breithardt; J., Cleland; J. C., Deharo; V., Delgado; P. M., Elliott; B., Gorenek; C. W., Israel; C., Leclercq; C., Linde; L., Mont; L., Padeletti; R., Sutton; P. E., Vardas; J. L., Zamorano; S., Achenbach; H., Baumgartner; J. J., Bax; H., Bueno; V., Dean; C., Deaton; C., Erol; R., Fagard; R., Ferrari; D., Hasdai; A. W., Hoes; P., Kirchhof; J., Knuuti; P., Kolh; P., Lancellotti; A., Linhart; P., Nihoyannopoulos; M. F., Piepoli; P., Ponikowski; P. A., Sirnes; J. L., Tamargo; M., Tendera; A., Torbicki; W., Wijns; S., Windecker; P., Kirchhof; C., Blomstrom Lundqvist; L. P., Badano; F., Aliyev; D., Bansch; H., Baumgartner; W., Bsata; P., Buser; P., Charron; J. C., Daubert; D., Dobreanu; S., Faerestrand; D., Hasdai; A. W., Hoes; J. Y., Le Heuzey; H., Mavrakis; T., Mcdonagh; J. L., Merino; M. M., Nawar; J. C., Nielsen; B., Pieske; L., Poposka; F., Ruschitzka; M., Tendera; I. C., Van Gelder; C. M., Wilson
abstract

Guidelines on cardiac pacing and cardiac resynchronization therapy

2013 - 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: The Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA) [Articolo su rivista]
Brignole, M.; Auricchio, A.; Baron Esquivias, G.; Bordachar, P.; Boriani, Giuseppe; Breithardt, O. A.; Cleland, J.; Deharo, J. C.; Delgado, V.; Elliott, P. M.; Gorenek, B.; Israel, C. W.; Leclercq, C.; Linde, C.; Mont, L.; Padeletti, L.; Sutton, R.; Vardas, P. E.; Zamorano, J. L.; Achenbach, S.; Baumgartner, H.; Bax, J. J.; Bueno, H.; Dean, V.; Deaton, C.; Erol, C.; Fagard, R.; Ferrari, R.; Hasdai, D.; Hoes, A. W.; Kirchhof, P.; Knuuti, J.; Kolh, P.; Lancellotti, P.; Linhart, A.; Nihoyannopoulos, P.; Piepoli, M. F.; Ponikowski, P.; Sirnes, P. A.; Tamargo, J. L.; Tendera, M.; Torbicki, A.; Wijns, W.; Windecker, S.; Kirchhof, P.; Blomstrom Lundqvist, C.; Badano, L. P.; Aliyev, F.; Bansch, D.; Baumgartner, H.; Bsata, W.; Buser, P.; Charron, P.; Daubert, J. C.; Dobreanu, D.; Faerestrand, S.; Hasdai, D.; Hoes, A. W.; Le Heuzey, J. Y.; Mavrakis, H.; Mcdonagh, T.; Merino, J. L.; Nawar, M. M.; Nielsen, J. C.; Pieske, B.; Poposka, L.; Ruschitzka, F.; Tendera, M.; Van Gelder, I. C.; Wilson, C. M.
abstract

Guidelines summarize and evaluate all available evidence, at the time of the writing process, on a particular issue, with the aim of assisting physicians in selecting the best management strategies for an individual patient with a given condition, taking into account the impact on outcome, as well as the risk–benefit ratio of particular diagnostic or therapeutic means. Guidelines are not substitutes, but are complements for textbooks and cover the ESC Core Curriculum topics. Guidelines and recommendations should help physicians to make decisions in their daily practice. However, the final decisions concerning an individual patient must be made by the responsible physician(s).

2013 - Acute changes in electromechanical parameters during different pacing configurations using a quadripolar left ventricular lead [Articolo su rivista]
Cinzia, Valzania; Maria J., Eriksson; Mauro, Biffi; Boriani, Giuseppe; Fredrik, Gadler
abstract

Purpose: Quadripolar left ventricular (LV) leads allow for several pacing configurations in candidates for cardiac resynchronization therapy (CRT). Whether different pacing configurations may affect LV dyssynchrony and systolic function is not completely known. We aimed to evaluate the acute effects of different pacing vectors on LV electromechanical parameters in patients implanted with a quadripolar LV lead. Methods: In this two-centre study, within 1 month of implantation 21 CRT patients (65 ± 8 years, 76 % men, 38 % ischemic) receiving a quadripolar LV lead (Quartet 1458Q, St Jude Medical) underwent LV capture threshold assessment, intracardiac electrogram optimization, and two-dimensional echocardiography during four pacing configurations: D1-P4, P4-RV coil, D1-RV coil, and P4-M2. LV dyssynchrony and contractile function were expressed by septal-to-lateral delay and global longitudinal strain (GLS). Results: LV capture threshold varied between the configurations (P < 0.001), showing higher values in the configurations P4-RV coil and P4-M2. Septal-to-lateral delay decreased in the configurations D1-P4 and D1-RV coil (P = 0.003 and P = 0.033 vs. spontaneous rhythm, respectively). GLS improved significantly vs. spontaneous rhythm only in the configuration D1-P4 (from -8.6 ± 3.5 to -11.0 ± 3.2 %, P = 0.001). Accordingly, an increase in stroke volume and a decrease in mitral regurgitation were observed in the configuration D1-P4 (P ≤ 0.001 vs. spontaneous rhythm). Conclusions: In CRT patients receiving a quadripolar LV lead, significant variations in electromechanical parameters were observed by changing pacing vector. Individually targeting the optimal pacing site may enhance the acute haemodynamic response to CRT. © 2013 Springer Science+Business Media New York.

2013 - Aritimie cardiache, morte cardiaca improvvisa, sincope [Capitolo/Saggio]
Boriani, Giuseppe; Martignani, C.
abstract

Definizione e trattamento delle aritmie

2013 - Assessing the outcomes of implantable cardioverter defibrillator treatment in a real world setting: results from hospital record data [Articolo su rivista]
S., Ghislandi; A., Torbica; Boriani, Giuseppe
abstract

Background: A plethora of clinical studies have assessed the benefits of implantable cardioverter defibrillators (ICDs) and supported their use in clinical practice. However, evidence on the safety and efficacy of ICDs appears insufficient to support expansion of their use in clinical practice, and more information on their impact in real life settings is warranted. This paper aims to investigate the impact of ICDs using a large administrative dataset reflecting actual clinical practice. Methods: Data were obtained from the hospital discharge database of the Friuli Venezia Giulia region in Italy containing patient-level information on 169,488 cases. Data on mortality outside hospital were obtained from regional sources. Exact matching method was used to estimate the outcomes associated with ICDs: mortality, length of stay, re-hospitalization and regional expenditure. The method was applied in two steps. First, patients with ICDs were matched with those without using the following: age class (by 5 years), gender, year of admission, type of admission (day hospital vs. ordinary) and primary diagnosis. In the second step, matching included also Charlson Comorbidities Index. Exact matching average treatment effect on the treated (ATT) was used as a main measure of impact. Results: Compared with matched controls, treatment with ICDs was associated with lower mortality (absolute risk reduction 10.6% at 1 year and 8.3% at 2 and 8.4% at 3 years, p &lt; 0.001 and hazard ratio 0.80, p &lt; 0.001), greater regional expenditure at index hospitalization (ATT: (sic)9459.64, p &lt; 0.001) and during follow up (ATT: (sic)1707.29, p &lt; 0.001) and higher re-hospitalization rate (ATT: 0.53, p &lt; 0.001). No significant difference was found for length of stay (9.07 vs. 8.86 days). The results were maintained after more restrictive matching was applied. Conclusions: Assessing the impact of innovative, expensive medical technologies on the basis of real world data is warranted, especially when there are barriers to implementation. Hospital administrative datasets can be of great value when a technology such as the ICD is implemented in a relatively small sample of patients, to allow use of exact matching techniques.

2013 - Atrial Fibrillation in Patients with Cardiac Resynchronization Therapy: Clinical Management and Outcome [Articolo su rivista]
Boriani, Giuseppe; Battistini, Paola; Diemberger, Igor; Ziacchi, Matteo; Valzania, Cinzia; Martignani, Cristian; Biffi, Mauro
abstract

Atrial fibrillation (AF) and heart failure (HF) are two emerging epidemics in the cardiovascular field and are strictly inter-related since may directly predispose to each other. Cardiac resynchronization therapy (CRT) has emerged as an important therapeutic option for selected HF patients with LV dysfunction and ventricular dyssynchrony. However almost all RCTs demonstrated the CRT effectiveness in patients in sinus rhythm (SR), including permanent AF among the exclusion criteria. In patients with paroxysmal or persistent AF strategies for rhythm control can be applied, but usually with limited efficacy. Furthermore, rhythm control strategy did not result superior to rate-control in patients with heart failure. AF ablation in HF patients is usually performed only in selected centres. In patients with permanent or long-standing AF and a CRT device the option of AVN ablation offers the advantage of allowing >95% biventricular pacing. AF implies a harmful increase in thromboembolic risk. Detection of AF in patients treated with a CRT device is enhanced by device diagnostic capabilities, that allow detection of episodes of atrial tachyarrythmias, including silent AF. In these cases decision making on appropriate antithrombotic prophy/laxis has to consider clinical risk stratification, usually applying CHADS2 and CHA2DS2VASc scores. In summary, in order to maximise outcome, AF in patients with CRT prompts the need to appropriately decide on antithromboembolic prophylaxis (according to risk stratifications), as well as on rate and/or rhythm control strategies, with the aim to allow constant biventricular pacing. In this perspective, AVN ablation has an important role since by inducing pace-maker dependency guarantees continuous biventricular pacing.

2013 - Cardiac Resynchronization Therapy in Patients With Atrial Fibrillation. The CERTIFY Study (Cardiac Resynchronization Therapy in Atrial Fibrillation Patients Multinational Registry) [Articolo su rivista]
Gasparini, Maurizio; Leclercq, Christophe; Lunati, Maurizio; Landolina, Maurizio; Auricchio, Angelo; Santini, Massimo; Boriani, Giuseppe; Lamp, Barbara; Proclemer, Alessandro; Curnis, Antonio; Klersy, Catherine; Leyva, Francisco
abstract

Abstract OBJECTIVES: The purpose of this study is to determine whether, in patients with atrial fibrillation (AF) undergoing cardiac resynchronization therapy (CRT), atrioventricular junction ablation (AVJA) is associated with a better outcome than treatment with rate-slowing drugs. BACKGROUND: Different trials have demonstrated that CRT is effective in treating heart failure (HF) patients who are in sinus rhythm (SR). No trials have addressed whether CRT confers similar benefits on AF patients, with or without AVJA. METHODS: The clinical outcomes of CRT for patients with permanent AF undergoing CRT combined with either AVJA (n = 443) or rate-slowing drugs (n = 895) were compared with those of SR patients (n = 6,046). RESULTS: Median follow-up was 37 months. Total mortality (6.8 vs. 6.1 per 100 person-years) and cardiac mortality (4.2 vs. 4.0) were similar for patients with AF+AVJA and patients in SR (both p = NS). In contrast, the AF+drugs group had a higher total and cardiac mortality than the SR group and the AF+AVJA group (11.3 and 8.1, respectively; p &lt; 0.001). On multivariable analysis, AF+AVJA had total mortality (hazard ratio [HR]: 0.93, 95% confidence interval [CI]: 0.74 to 1.67) and cardiac mortality (HR: 0.88, 95% CI: 0.66 to 1.17) similar to that of the SR group, independent of known confounders. The AF+drugs group, however, had a higher total mortality (HR: 1.52, 95% CI: 1.26 to 1.82) and cardiac mortality (HR: 1.57, 95% CI: 1.27 to 1.94) than both the SR group and the AF+AVJA group (both p &lt; 0.001). CONCLUSIONS: Long-term survival after CRT among patients with AF+AVJA is similar to that observed among patients in SR. Mortality is higher for AF patients treated with rate-slowing drugs. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

2013 - Correspondence: Left ventricular pacing rate lower than expected during manual pacing threshold test in a biventricular defibrillator Response [Articolo su rivista]
E. D., Maria; M., Biffi; Boriani, Giuseppe
abstract

not available

2013 - Cost Effectiveness of Treatments for Stroke Prevention in Atrial Fibrillation: Focus on the Novel Oral Anticoagulants [Articolo su rivista]
Charalampos, Kasmeridis; Stavros, Apostolakis; Lars, Ehlers; Lars H., Rasmussen; Boriani, Giuseppe; Gregory Y. H., Lip
abstract

For more than 5 decades, the only available treatment for the prevention of atrial fibrillation (AF)-related stroke were the vitamin K antagonists. Recently, novel oral anticoagulants (NOAC) have been approved for the prevention of AF-related stroke. In the present article, the cost effectiveness of AF-related stroke-prevention strategies is reviewed. The emphasis on NOACs aims to provide an overview of their impact on health economics based on the published cost-effectiveness analyses. The available evidence suggests that the balance from the efficacy and safety point of view makes the treatment with the NOACs a cost-effective alternative to warfarin. Thus, the NOACs offer efficacy, safety and convenience, as well as cost effectiveness, for stroke prevention in AF. © 2013 Springer International Publishing Switzerland.

2013 - DEVICE DETECTED ATRIAL FIBRILLATION AND RISK FOR STROKE: AN ANALYSIS OF MORE THAN 10,000 PATIENTS FROM THE SOS AF PROJECT (STROKE PREVENTION STRATEGIES BASED ON ATRIAL FIBRILLATION INFORMATION FROM IMPLANTED DEVICES) [Abstract in Rivista]
Glotzer, T; Boriani, Giuseppe; Santini, M; West, T; De Melis, M; Sepsi, M; Gasparini, M; Lewalter, T; Camm, Aj; Singer, D.
abstract

not available

2013 - Edoxaban versus warfarin in patients with atrial fibrillation [Articolo su rivista]
Giugliano, R. P.; Ruff, C. T.; Braunwald, E.; Murphy, S. A.; Wiviott, S. D.; Halperin, J. L.; Waldo, A. L.; Ezekowitz, M. D.; Weitz, J. I.; Spinar, J.; Ruzyllo, W.; Ruda, M.; Koretsune, Y.; Betcher, J.; Shi, M.; Grip, L. T.; Patel, S. P.; Patel, I.; Hanyok, J. J.; Mercuri, M.; Antman, E. M.; Peruzzotti-Jametti, L.; Malynovsky, Y.; Morin, S. E.; Hoffman, E. B.; Deenadayalu, N.; Lanz, H.; Curt, V.; Duggal, A.; Dave, J.; Morgan, D.; Choi, Y.; Shi, M.; Jin, J.; Xie, J.; Crerand, W.; Kappelhof, J.; Maxwell, W.; Skinner, M.; Selicato, G.; Otto, C.; Reissner, C.; Smith, K.; Ostroske, J.; Ron, A.; Connolly, S.; Camm, J.; Paolasso, E.; Aylward, P.; Heidbuchel, H.; Nicolau, J. C.; Goudev, A.; Roy, D.; Corbalan, R.; Yang, Y.; Botero, R.; Bergovec, M.; Grande, P.; Hassager, C.; Voitk, J.; Huikuri, H.; Nieminen, M.; Blanc, J. J.; LeHeuzey, J. Y.; Mitrovic, V.; Alexopoulos, D.; Sotomora, G.; Kiss, R.; SomaRaju, B.; Lewis, B.; Merlini, P.; Metra, M.; Yamashita, T.; Garcia-Castillo, A.; Ophuis, T.; White, H.; Atar, D.; Horna, M.; Babilonia, N.; Morais, J.; Dorobantu, M.; Ostojic, M.; Duris, T.; Dalby, A.; Chung, N.; Zamorano, J. L.; Juul-Moller, S.; Moccetti, T.; Chen, S. A.; Sritara, P.; Oto, A.; Parkhomenko, A.; Senior, R.; Verheugt, F.; Skene, A.; Anderson, J.; Bauer, K.; Easton, J. D.; Goto, S.; Lowe, C.; Awtry, E.; Berger, C. J.; Croce, K.; Desai, A.; Gelfand, E.; Goessling, W.; Greenberger, N. J.; Ho, C.; Leeman, D. E.; Link, M. S.; Norden, A. D.; Pande, A.; Rost, N.; Ruberg, F.; Silverman, S.; Singhal, A.; Vita, J. A.; Vogelmann, O.; Gonzalez, C.; Ahuad Guerrero, R.; Rodriguez, M.; Albisu, J.; Rosales, E.; Allall, O.; Reguero, M.; Alvarez, C.; Garcia, M.; Ameriso, S.; Ameriso, P.; Amuchastegui, M.; Caceres, M.; Beloscar, J.; Petrucci, J.; Berli, M.; Budassi, N.; Valle, M.; Bustamante Labarta, G.; Saravia, M.; Caccavo, A.; Fracaro, V.; Cartasegna, L.; Novas, V.; Caruso, O.; Zarandon, R. S.; Colombo, H.; Morandini, M.; Cuello, J.; Rosell, M.; Cuneo, C.; Bocanera, M.; D'Amico, A.; Cendali, G.; Dran, R.; Moreno, V.; Estol, C.; Davolos, M.; Facello, A.; Facello, M.; Falu, E.; Iriarte, M.; Femenia, F.; Arrieta, M.; Fuselli, J.; Zanotti, A.; Gant Lopez, J.; Meiller, F.; Garcia Duran, R.; Perlo, D.; Garrido, M.; Ceirano, C.; Giacomi, G.; Eden, M.; Giannaula, R.; Huerta, M.; Goicoechea, R.; von Wulffen, M.; Hominal, M.; Bianchini, M.; Jure, H.; Jure, D.; Kevorkian, R.; Monaco, F.; Lanternier, G.; Belcuore, M.; Liniado, G.; Iglesias, M.; Litvak, B.; Nigro, A.; Llanos, J.; Vignau, S.; Lorente, C.; Shatsky, K.; Lotti, J.; Raimondi, G.; Mackinnon, I.; Carne, M.; Manuale, O.; Calderon, M.; Marino, J.; Funes, I.; Muntaner, J.; Gandur, H.; Nul, D.; Verdini, E.; Piskorz, D.; Tommasi, A.; Povedano, G.; Casares, E.; Pozzer, D.; Fernandez, E.; Prado, A.; Venturini, C.; Ramos, H.; Navarrete, S.; Alvarez, M.; Sanchez, A.; Bowen, L.; Sanjurjo, M.; Codutti, O.; Saravia Toledo, S.; Formoso, I.; Schmidberg, J.; Goloboulicz, A.; Schygiel, P.; Buzzetti, C.; Severino, P.; Morara, P.; Sosa Liprandi, M.; Teves, M.; Vico, M.; Morell, Y.; Anderson, C.; Paraskevaidis, T.; Arstall, M.; Hoffmann, B.; Colquhoun, D.; Price-Smith, S.; Crimmins, D.; Slattery, A.; Dart, A.; Kay, S.; Davis, S.; Silver, G.; Flecknoe-Brown, S.; Roberts, J.; Gates, P.; Jones, S.; Lehman, R.; Morrison, H.; McKeirnan, M.; Li, J.; Paul, V.; Batta, C.; Purnell, P.; Perrett, L.; Szto, G.; O'Shea, V.; Capiau, L.; Banaeian, F.; De Bleecker, J.; de Koning, K.; De Tollenaere, M.; De Bruyne, L.; Desfontaines, P.; Tincani, G.; Meeusen, K.; Herzet, J.; Malmendier, D.; Mairesse, G.; Raepers, M.; Parque, J.; Clinckemaille, N.; Scavee, C.; Huyberechts, D.; Stockman, D.; Jacobs, C.; Vandekerckhove, Y.; Derycker, K.; Vanwelden, J.; van Welden, J.; Vervoort, G.; Mestdagh, I.; Vrolix, M.; Beerts, C.; Wollaert, B.; Denie, D.; Amato Vincenzo de Paola, A.; Coutinho, E.; Andrade Lotufo, P.; de Melo, R. F.; Atie, J.; Motta, C.; Augusto Alves da Costa, F.; Ferraz, R. F.; Bertolim Precoma, D.; Sehnem, E.; Botelho, R.; Cun
abstract

BACKGROUND: Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known. METHODS: We conducted a randomized, double-blind, double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation (median follow-up, 2.8 years). The primary efficacy end point was stroke or systemic embolism. Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period. The principal safety end point was major bleeding. RESULTS: The annualized rate of the primary end point during treatment was 1.50% with warfarin (median time in the therapeutic range, 68.4%), as compared with 1.18% with high-dose edoxaban (hazard ratio, 0.79; 97.5% confidence interval [CI], 0.63 to 0.99; P&lt;0.001 for noninferiority) and 1.61% with low-dose edoxaban (hazard ratio, 1.07; 97.5% CI, 0.87 to 1.31; P=0.005 for noninferiority). In the intention-to-treat analysis, there was a trend favoring high-dose edoxaban versus warfarin (hazard ratio, 0.87; 97.5% CI, 0.73 to 1.04; P=0.08) and an unfavorable trend with low-dose edoxaban versus warfarin (hazard ratio, 1.13; 97.5% CI, 0.96 to 1.34; P=0.10). The annualized rate of major bleeding was 3.43% with warfarin versus 2.75% with high-dose edoxaban (hazard ratio, 0.80; 95% CI, 0.71 to 0.91; P&lt;0.001) and 1.61% with low-dose edoxaban (hazard ratio, 0.47; 95% CI, 0.41 to 0.55; P&lt;0.001). The corresponding annualized rates of death from cardiovascular causes were 3.17% versus 2.74% (hazard ratio, 0.86; 95% CI, 0.77 to 0.97; P=0.01), and 2.71% (hazard ratio, 0.85; 95% CI, 0.76 to 0.96; P=0.008), and the corresponding rates of the key secondary end point (a composite of stroke, systemic embolism, or death from cardiovascular causes) were 4.43% versus 3.85% (hazard ratio, 0.87; 95% CI, 0.78 to 0.96; P=0.005), and 4.23% (hazard ratio, 0.95; 95% CI, 0.86 to 1.05; P=0.32). CONCLUSIONS: Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes. (Funded by Daiichi Sankyo Pharma Development; ENGAGE AF-TIMI 48 ClinicalTrials.gov number, NCT00781391.) Copyright © 2013 Massachusetts Medical Society.

2013 - Erratum: From lead management to implanted patient management: Systematic review and meta-analysis of the last 15 years of experience in lead extraction (Expert Review of Medical Devices (2013) 10:4 (551-573) DOI: 10.1586/14760584.2013.811837) [Articolo su rivista]
Diemberger, I.; Mazzotti, A.; Biffi, M.; Massaro, G.; Martignani, C.; Ziacchi, M.; Reggiani, M. L. B.; Battistini, P.; Boriani, G.
abstract

2013 - From lead management to implanted patient management: systematic review and meta-analysis of the last 15 years of experience in lead extraction [Articolo su rivista]
Igor, Diemberger; Andrea, Mazzotti; Mauro, Biffi; Giulia, Massaro; Cristian, Martignani; Matteo, Ziacchi; Maria Letizia Bacchi, Reggiani; Paola, Battistini; Boriani, Giuseppe
abstract

Percutaneous lead extraction is considered a safe and effective procedure, although published results derive primarily from cohort studies. The authors performed a systematic review and meta-analysis of the last 15 years' experience in this field, to give an objective evaluation of the efficacy and safety of this procedure. Moreover, the subsequent metaregression analysis enabled the identification of the main factors influencing these results: patient age, presence of leads in situ for more than 1 year, presence of device infection and use of laser sheath. These findings are significant in order to improve our extraction approach, data reporting and future research

2013 - Health technology assessment in interventional electrophysiology and device therapy: a position paper of the European Heart Rhythm Association. [Articolo su rivista]
Boriani, Giuseppe; Maniadakis, N; Auricchio, A; Müller Riemenschneider, F; Fattore, G; Leyva, F; Mantovani, L; Siebert, M; Willich, Sn; Vardas, P; Kirchhof, P.
abstract

not available

2013 - Impact of extending device longevity on the long-term costs of implantable cardioverter-defibrillator therapy: a modelling study with a 15-year time horizon. [Articolo su rivista]
Boriani, Giuseppe; Braunschweig, F; Deharo, Jc; Leyva, F; Lubinski, A; Lazzaro, C.
abstract

AIMS: To determine the long-term costs of extending device longevity in four patient populations requiring a single-chamber implantable cardioverter-defibrillator (ICD) or requiring cardiac resynchronization therapy with defibrillation (CRT-D) device over a 15-year time window.METHODS AND RESULTS: We considered patient populations with an accepted indication for a single-chamber ICD for prevention of sudden cardiac death in the context of preserved (Population A) or impaired (Population B) left ventricular function; or with indication for a CRT-D device in the context of heart failure in New York Heart Association class II (Population C) or III (Population D). Expected patient survival and a cost analysis, including the cost of complications, was undertaken from a hospital perspective. Extended device longevity of 5 vs. 9 years for ICDs (Populations A and B); 4 vs. 7 years for CRT-Ds (Populations C and D) were considered. Over a 15-year time horizon, total, yearly, and per diem savings, per patient, from extending ICD longevity to 9 years were €10 926.91, €728.46, and €1.99 for Population A, and €7661.32, €510.75, and €1.40 for Population B. Total, yearly, and per diem savings from extending CRT-D longevity to 7 years were €13 630.38, €908.69, and €2.49 for Population C, and €10 968.29, €731.22, and €2.00 for Population D. Avoidance of a generator replacement amounted up to 46.6-62.5% of the saving.CONCLUSION: Extending device longevity has an important effect on the long-term cost of device therapy, both for ICD and CRT-D. This has important implications for device choice.

2013 - Implantation of cardioverter-defibrillator: Effects on shoulder function [Articolo su rivista]
Diemberger, Igor; Pegreffi, Francesco; Mazzotti, Andrea; Foschi, Elia; Martignani, Cristian; Belli, Guido; Biffi, Mauro; Ziacchi, Matteo; Branzi, Angelo; Grigioni, Francesco; Maietta Latessa, Pasqualino; Porcellini, Giuseppe; Tentoni, Claudio; Boriani, Giuseppe
abstract

Abstract BACKGROUND: Subcutaneous almost substituted subpectoral approach of implantable cardioverter-defibrillator (ICD) implantation as a less invasive surgical technique. However, the impact of this change in placement site on procedure-related shoulder impairment is poorly understood. METHODS: Candidates for ICD implantation were prospectively evaluated at baseline, 2-weeks and 3-months after the procedure. Assessment of shoulder function included: Constant Score, Numeric Rating Scale (NRS) for pain and the Disability of the Arm, Shoulder and Hand (DASH) scoring method. The Short Form-36 (SF-36) questionnaire was adopted for quality of life. RESULTS: Fifty consecutive patients were enrolled (21 single-chamber, 5 dual-chamber and 24 biventricular ICD). Significant changes in the short term were observed: physical component summary (regarding SF-36) decreased from 44.5±9.1 to 41.8±11.4 (p=0.016), patients with NRS >1 increased from 14% to 44% (p<0.001), DASH score increased from 1.29 [interquartile range 0.00-10.34] to 30.60 [interquartile range 12.93-46.34] (p<0.001). Notably, only the shoulder ipsilateral to implantation site presented a decrease in Constant Score (76.00 [interquartile range 61.37-86.87] vs. 95.75 [interquartile range 91.37-98.00]; p<0.001). After three months most of the parameters seemed to have recovered, except for range of motion. Procedure-related increase in pain (i.e. NRS increase ≥1 point) was the most important independent predictor of shoulder impairment, in terms of Constant Score modification (r=0.570; p<0.001). CONCLUSIONS: ICD implantation is frequently associated with ipsilateral shoulder impairment which tends to recover within 3-months. These data positively compare with the subpectoral approach and should be considered for future research regarding impact of ICD implant on physical well-being and quality of life.

2013 - Incidence and Predictors of Postoperative Atrial Fibrillation in Kidney Transplant Recipients. [Articolo su rivista]
La Manna, G; Boriani, Giuseppe; Capelli, I; Marchetti, A; Grandinetti, V; Spazzoli, A; Dalmastri, V; Todeschini, P; Rucci, P; Stefoni, S.
abstract

BACKGROUND: Postoperative atrial fibrillation (POAF) is a complication of cardiothoracic and noncardiothoracic surgery. Kidney transplant recipients bear several known risk factors and may have a higher incidence of POAF. We retrospectively studied kidney and kidney/liver transplant recipients to estimate their POAF incidence and identify relevant risk factors. We also adapted a clinical score originally designed to predict thromboembolic risk in atrial fibrillation (AF; CHA2DS2-VASc) for assessing transplant patients. METHODS: We reviewed the clinical charts of kidney or kidney/liver transplant recipients from January 2005 to December 2008 at St. Orsola University Hospital Kidney Transplant Centre. Patients with and without POAF were compared on a number of clinical, laboratory, and instrumental data. RESULTS: The POAF incidence in kidney transplant recipients was 8.2%. Risk factors for POAF identified in univariate analyses included older recipient age, history of myocardial infarction, history of AF, liver/kidney transplantation, arterial stiffness, atherosclerotic plaques in the aorta or lower limbs, and diabetes mellitus. In a multivariate analysis, age, myocardial infarction history and combined liver/kidney transplantation were significant independent predictors of POAF. The modified CHA2DS2-VASc score proved to have a better predictive validity that the original CHA2DS2-VASc (area under the curve=0.71, 95% confidence interval=0.63-0.79 vs. area under the curve=0.62, 95% confidence interval=0.52-0.73, respectively). CONCLUSION: AF is a notable complication of kidney, and particularly simultaneous liver/kidney, transplant surgery. Age, previous myocardial infarction, and simultaneous liver/kidney transplant independently predicted POAF. The modified CHA2DS2-VASc score could be useful to predict POAF risk in kidney transplant candidates.

2013 - Incidenza e fattori predittivi di fibrillazione atriale post operatoria nei riceventi di trapianto renale [Articolo su rivista]
I., Capelli; P., Todeschini; A., Marchetti; V., Grandinetti; A., Spazzoli; P., Rucci; Boriani, Giuseppe; G., La Manna; M. P., Scolari; S., Stefoni
abstract

la fibrillazione atriale post operatoria è una complicanza della chirurgia cardiotoracica e non cardiotoracica . I riceventi di trapianto renale presentano diversi fattori di rischio noti e sono esposti a maggiore incidenza di fibrillazione atriale.

2013 - Left ventricular pacing rate lower than expected during manual pacing threshold test in a biventricular defibrillator. [Articolo su rivista]
De Maria, E; Biffi, M; Boriani, Giuseppe
abstract

non disponibile

2013 - Letter by Gasparini and Boriani Regarding Article, "Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation: Results From the Resynchronization for Ambulatory Heart Failure Trial (RAFT)" [Articolo su rivista]
M., Gasparini; Boriani, Giuseppe
abstract

Results from the resynchronization for ambulatory heart failure trial (RAFT)

2013 - Personalized management of atrial fibrillation: Proceedings from the fourth Atrial Fibrillation competence NETwork/European Heart Rhythm Association consensus conference [Articolo su rivista]
P., Kirchhof; G., Breithardt; E., Aliot; S., Al Khatib; S., Apostolakis; A., Auricchio; C., Bailleul; J., Bax; G., Benninger; C., Blomstrom Lundqvist; L., Boersma; Boriani, Giuseppe; A., Brandes; H., Brown; M., Brueckmann; H., Calkins; B., Casadei; A., Clemens; H., Crijns; R., Derwand; D., Dobrev; M., Ezekowitz; T., Fetsch; A., Gerth; A., Gillis; M., Gulizia; G., Hack; L., Haegeli; S., Hatem; K., Georg Hausler; H., Heidbuchel; J., Hernandez Brichis; P., Jais; L., Kappenberger; J., Kautzner; S., Kim; K. H., Kuck; D., Lane; A., Leute; T., Lewalter; R., Meyer; L., Mont; G., Moses; M., Mueller; F., Munzel; M., Nabauer; J. C., Nielsen; M., Oeff; A., Oto; B., Pieske; R., Pisters; T., Potpara; L., Rasmussen; U., Ravens; J., Reiffel; I., Richard Lordereau; H., Schafer; U., Schotten; W., Stegink; K., Stein; G., Steinbeck; L., Szumowski; L., Tavazzi; S., Themistoclakis; K., Thomitzek; I. C., Van Gelder; B., von Stritzky; A., Vincent; D., Werring; S., Willems; G. Y. H., Lip; A. J., Camm
abstract

The management of atrial fibrillation (AF) has seen marked changes in past years, with the introduction of new oral anticoagulants, new antiarrhythmic drugs, and the emergence of catheter ablation as a common intervention for rhythm control. Furthermore, new technologies enhance our ability to detect AF. Most clinical management decisions in AF patients can be based on validated parameters that encompass type of presentation, clinical factors, electrocardiogram analysis, and cardiac imaging. Despite these advances, patients with AF are still at increased risk for death, stroke, heart failure, and hospitalizations. During the fourth Atrial Fibrillation competence NETwork/European Heart Rhythm Association (AFNET/EHRA) consensus conference, we identified the following opportunities to personalize management of AF in a better manner with a view to improve outcomes by integrating atrial morphology and damage, brain imaging, information on genetic predisposition, systemic or local inflammation, and markers for cardiac strain. Each of these promising avenues requires validation in the context of existing risk factors in patients. More importantly, a new taxonomy of AF may be needed based on the pathophysiological type of AF to allow personalized management of AF to come to full fruition. Continued translational research efforts are needed to personalize management of this prevalent disease in a better manner. All the efforts are expected to improve the management of patients with AF based on personalized therapy.

2013 - Predicting the Quality of Anticoagulation During Warfarin Therapy [Articolo su rivista]
Boriani, Giuseppe
abstract

N/A

2013 - Prevention of Sudden Cardiac Death With Implantable Cardioverter-Defibrillators in Children and Adolescents With Hypertrophic Cardiomyopathy [Articolo su rivista]
B. J., Maron; P., Spirito; M. J., Ackerman; S. A., Casey; C., Semsarian; I. E., N.; K. M., Shannon; E. A., Ashley; S. M., Day; G., Pacileo; F., Formisano; E., Devoto; A., Anastasakis; J. M., Bos; A., Woo; C., Autore; R. H., Pass; Boriani, Giuseppe; R. F., Garberich; A. K., Almquist; M. W., Russell; L., Boni; S., Berger; M. S., Maron; M. S., Link
abstract

Objectives The aim of this study was to determine the efficacy of implantable cardioverter-defibrillators (ICDs) in children and adolescents with hypertrophic cardiomyopathy (HCM). Background HCM is the most common cause of sudden death in the young. The availability of ICDs over the past decade for HCM has demonstrated the potential for sudden death prevention, predominantly in adult patients. Methods A multicenter international registry of ICDs implanted (1987 to 2011) in 224 unrelated children and adolescents with HCM judged at high risk for sudden death was assembled. Patients received ICDs for primary (n = 188) or secondary (n = 36) prevention after undergoing evaluation at 22 referral and nonreferral institutions in the United States, Canada, Europe, and Australia. Results Defibrillators were activated appropriately to terminate ventricular tachycardia or ventricular fibrillation in 43 of 224 patients (19%) over a mean of 4.3 +/- 3.3 years. ICD intervention rates were 4.5% per year overall, 14.0% per year for secondary prevention after cardiac arrest, and 3.1% per year for primary prevention on the basis of risk factors (5-year cumulative probability 17%). The mean time from implantation to first appropriate discharge was 2.9 +/- 2.7 years (range to 8.6 years). The primary prevention discharge rate terminating ventricular tachycardia or ventricular fibrillation was the same in patients who underwent implantation for 1, 2, or >= 3 risk factors (12 of 88 [14%], 10 of 71 [14%], and 4 of 29 [14%], respectively, p = 1.00). Extreme left ventricular hypertrophy was the most common risk factor present (alone or in combination with other markers) in patients experiencing primary prevention interventions (17 of 26 [65%]). ICD-related complications, particularly inappropriate shocks and lead malfunction, occurred in 91 patients (41%) at 17 +/- 5 years of age. Conclusions In a high-risk pediatric HCM cohort, ICD interventions terminating life-threatening ventricular tachyarrhythmias were frequent. Extreme left ventricular hypertrophy was most frequently associated with appropriate interventions. The rate of device complications adds a measure of complexity to ICD decisions in this age group. (J Am Coll Cardiol 2013;61:1527-35) (C) 2013 by the American College of Cardiology Foundation

2013 - Profilo psicologico e psicosomatico di pazienti sottoposti a Implantable Cardioverter Defibrillator (ICD): uno studio di follow-up a breve termine. [Abstract in Rivista]
Rafanelli, C; Gostoli, S; Luongo, C; Roncuzzi, R; Biffi, M; Boriani, Giuseppe
abstract

Obiettivi: Scopo dello studio è valutare 1) la presenza di disagio psicologico e vulnerabilità psicosomatica e 2) l’associazione tra variabili psicologiche e decorso clinico cardiologico in soggetti portatori di Implantable Cardioverter Defibrillator (ICD). Metodi: Dei 21 pazienti afferenti all’UO cardiologia del policlinico Sant’Orsola (Bologna) per sottoporsi ad impianto ICD, sono state considerate variabili demografiche, cliniche, psicologiche e psicosomatiche un giorno prima dell’intervento e 90 giorni dopo. Gli strumenti utilizzati, alla baseline e al follow-up, comprendevano le interviste SCID (ansia e depressione) e DCPR e i test auto-valutativi SQ, PWB, DS-14, SF-36, PSI. Risultati e conclusioni: Il campione di pazienti ICD mostra un’alta prevalenza, rispetto alla popolazione generale, di distimia (DSM), di sintomatologia ansiosa, depressiva, somatica (SQ), di distress psicologico e di comportamento abnorme di malattia (PSI). Presenta inoltre negazione di malattia, umore irritabile e demoralizzazione (DCPR); in particolare gli ultimi due si associano a minore benessere psicologico e maggiore disagio. Sia il disagio psicologico clinico e sub-clinico (tranne la sintomatologia ansiosa) che le sindromi psicosomatiche persistono al follow-up, non confermando una diretta associazione tra impianto ICD e sviluppo di sintomi psicopatologici. Non si riscontrano modificazioni nel decorso clinico post-impianto associate alle variabili psicologiche. Sarà importante monitorare per un periodo più lungo un campione più ampio di pazienti, in particolare valutando se la persistenza di vulnerabilità psicosomatica associata ad una variazione del benessere psicologico possa costituire un fattore di rischio per complicanze cardiache.

2013 - Short-spaced dipole for managing phrenic nerve stimulation in patients with CRT: The "phrenic nerve mapping and stimulation EP" catheter study. [Articolo su rivista]
Biffi, M; Zanon, F; Bertaglia, E; Padeletti, L; Varbaro, A; De Santo, T; Boriani, Giuseppe; Yang, Z.
abstract

Phrenic nerve stimulation (PNS), occurring in 33%-37% of the patients with cardiac resynchronization therapy (CRT), is a limiting factor when implanting left ventricular (LV) leads from coronary veins. OBJECTIVE: To test the hypothesis that PNS occurrence is related to bipolar electrode spacing. METHODS: During standard CRT defibrillator implant procedures, a 5-F diagnostic electrophysiology catheter with 10 electrodes, spaced 2-5-2 mm, was positioned in a cardiac vein suitable for permanent LV lead placement. Pacing in the unipolar configuration identified the site with the lowest PNS threshold. PNS and left ventricular pacing (LVP) thresholds were then measured in different configurations at 0.5 ms: unipolar, each LV electrode served as the cathode in turn; and bipolar with different electrode spacing, cathode being the electrode with the lowest unipolar PNS threshold. RESULTS: From February to September 2010, 40 patients undergoing CRT implantation were enrolled in 4 centers in Italy. It was possible to identify PNS and perform a complete set of measurements in 23 patients. A bipolar electrode spacing of 2 mm resulted in higher PNS thresholds in bipolar configurations han did a bipolar electrode spacing of ≥ 5 mm. However, no significant increase in the LVP threshold was observed (P = ns). CONCLUSIONS: This experience suggests that LVP with a bipolar electrode spacing of 2 mm significantly increases the PNS threshold without affecting the LVP threshold, thereby increasing the possibility of delivering CRT when the LV lead is placed in proximity to the phrenic nerve

2013 - The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) Randomized Controlled Trial: Phase 1 Results on Dynamics of Early Intervention With Remote Monitoring [Articolo su rivista]
Boriani, Giuseppe; Antoine Da, Costa; Renato Pietro, Ricci; Aurelio, Quesada; Stefano, Favale; Saverio, Iacopino; Francesco, Romeo; Arnaldo, Risi; Lorenza Mangoni di S., Stefano; Xavier, Navarro; Mauro, Biffi; Massimo, Santini; Haran, Burri
abstract

Background: Remote monitoring (RM) in patients with advanced heart failure and cardiac resynchronization therapy defibrillators (CRT-D) may reduce delays in clinical decisions by transmitting automatic alerts. However, this strategy has never been tested specifically in this patient population, with alerts for lung fluid overload, and in a European setting. Objective: The main objective of Phase 1 (presented here) is to evaluate if RM strategy is able to reduce time from device-detected events to clinical decisions. Methods: In this multicenter randomized controlled trial, patients with moderate to severe heart failure implanted with CRT-D devices were randomized to a Remote group (with remote follow-up and wireless automatic alerts) or to a Control group (with standard follow-up without alerts). The primary endpoint of Phase 1 was the delay between an alert event and clinical decisions related to the event in the first 154 enrolled patients followed for 1 year. Results: The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group: 2 (25th-75th percentile, 1-4) days vs 29 (25th-75th percentile, 3-51) days respectively, P=.004. In-hospital visits were reduced in the Remote group (2.0 visits/patient/year vs 3.2 visits/patient/year in the Control group, 37.5% relative reduction, P&lt;.001). Automatic alerts were successfully transmitted in 93% of events occurring outside the hospital in the Remote group. The annual rate of all-cause hospitalizations per patient did not differ between the two groups (P=.65). Conclusions: RM in CRT-D patients with advanced heart failure allows physicians to promptly react to clinically relevant automatic alerts and significantly reduces the burden of in-hospital visits.

2013 - The use of imaging for electrophysiological and devices procedures: a report from the first European Heart Rhythm Association Policy Conference, jointly organized with the European Association of Cardiovascular Imaging (EACVI), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology. [Articolo su rivista]
Blomström Lundqvist, C; Auricchio, A; Brugada, J; Boriani, Giuseppe; Bremerich, J; Cabrera, Ja; Frank, H; Gutberlet, M; Heidbuchel, H; Kuck, Kh; Lancellotti, P; Rademakers, F; Winkels, G; Wolpert, C; Vardas, Pe
abstract

mplantations of cardiac devices therapies and ablation procedures frequently depend on accurate and reliable imaging modalities for pre-procedural assessments, intra-procedural guidance, detection of complications, and the follow-up of patients. An understanding of echocardiography, cardiovascular magnetic resonance imaging, nuclear cardiology, X-ray computed tomography, positron emission tomography, and vascular ultrasound is indispensable for cardiologists, electrophysiologists as well as radiologists, and it is currently recommended that physicians should be trained in several imaging modalities. There are, however, no current guidelines or recommendations by electrophysiologists, cardiac imaging specialists, and radiologists, on the appropriate use of cardiovascular imaging for selected patient indications, which needs to be addressed. A Policy Conference on the use of imaging in electrophysiology and device management, with representatives from different expert areas of radiology and electrophysiology and commercial developers of imaging and device technologies, was therefore jointly organized by European Heart Rhythm Association (EHRA), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology (ESCR). The objectives were to assess the state of the level of evidence and a first step towards a consensus document for currently employed imaging techniques to guide future clinical use, to elucidate the issue of reimbursement structures and health economy, and finally to define the need for appropriate educational programmes to ensure clinical competence for electrophysiologists, imaging specialists, and radiologists.

2013 - Trends in antiarrhythmic drug use after marketing authorization of dronedarone: comparison between Emilia Romagna (Italy) and Sweden. [Articolo su rivista]
Piccinni, C; Raschi, E; Poluzzi, E; Puccini, A; Cars, T; Wettermark, B; Diemberger, I; Boriani, Giuseppe; De Ponti, F.
abstract

PURPOSE: Our aim was to evaluate whether dronedarone authorization impacts antiarrhythmic drug prescribing in Sweden and Emilia Romagna (Italy). METHODS: Prescriptions of classes I and III antiarrhythmics, expressed as defined daily doses per thousand inhabitants per day (DDD/TID) were monthly using information collected from pharmacy-reimbursed databases. Interrupted time series analysis was applied to compare prescription data over the 2009-2011 period. RESULTS: In Emilia Romagna, the overall consumption of antiarrhythmics was six times as high as in Sweden (7.6 vs. 1.2 DDD/TID). In the first year on the market, dronedarone represented 1.0 % in Italy and 10.7 % in Sweden of the overall antiarrhythmic prescriptions. In Sweden, dronedarone authorization generated an increase in the prescription trend of antiarrhythmics (trend change +0.02; p < 0.001) without variation in amiodarone use In Emilia Romagna, dronedarone marketing did not influence the prescription pattern of either overall antiarrhythmics or amiodarone. CONCLUSIONS: Emilia Romagna and Sweden substantially differ in terms of overall antiarrhythmic use. Although clinical guidelines place dronedarone among first-choice treatments for atrial fibrillation, amiodarone prescribing was not affected in either country by the entry of dronedarone, probably due to a cautious approach by clinicians in line with regulatory recommendations and safety warnings.

2013 - Ventricular tachycardia/fibrillation early after defibrillator implantation in patients with hypertrophic cardiomyopathy is explained by a high risk subgroup of patients. [Articolo su rivista]
Alsheikh Ali, Aa; Link, Ms; Semsarian, C; Shen, Wk; Mark Estes NA, 3rd; Maron, Ms; Haas, Ts; Formisano, F; Boriani, Giuseppe; Spirito, P; Maron, B. J.
abstract

BACKGROUND: Implantable cardioverter-defibrillator (ICD) studies in patients with coronary artery disease report higher risk of ventricular tachycardia/fibrillation (VT/VF) early post-implant, potentially related to local proarrhythmic effects of ICD leads. OBJECTIVE: To characterize early and long-term risk of ICD discharge for VT/VF in a large hypertrophic cardiomyopathy (HCM) cohort. METHODS: By using HCM multicenter registry data, we compared long-term risk of VT/VF subsequent to an early post-implant period (a priori defined as within 3 months of implant) between patients with or without VT/VF within 3 months after ICD implantation. RESULTS: Over a median follow-up of 4.3 years, 109 of 506 (22%) patients with HCM who received ICDs received at least 1 ICD discharge for VT/VF. Risk of first ICD discharge for VT/VF was highest in the first year post-implant (10.8% per person-year; 95% confidence interval 7.9-13.8) and particularly in the first 3 months (17.0% per person-year; 95% confidence interval 9.8-24.3). Patients with early VT/VF (≤3 months post-implant) were older, and more commonly had secondary prevention ICDs following cardiac arrest or systolic dysfunction (end-stage HCM with ejection fraction<50%). Only 2 of 247 (0.7%) patients with primary prevention ICDs and preserved systolic function had early VT/VF. Patients with VT/VF early post-implant (≤3 months) had more than 5-fold higher risk for future VT/VF during long-term follow-up compared with patients without early VT/VF (adjusted hazard ratio 5.4; 95% confidence interval 2.3-12.6). CONCLUSIONS: High-risk patients with HCM and VT/VF early after ICD implantation are particularly prone to subsequent VT/VF throughout follow-up. Early ICD interventions for VT/VF are largely confined to patients with prior cardiac arrest or systolic dysfunction and therefore more likely driven by higher arrhythmic risk rather than lead-related proarrhythmia.

2013 - Wytyczne ESC dotycza̧ce stymulacji serca i terapii resynchronizuja̧cej w 2013 ROKU [Articolo su rivista]
Brignole, M; Auricchio, A; Baron Esquivias, G; Bordachar, P; Boriani, Giuseppe; Breithardt, O; Cleland, J; Deharo, J; Delgado, V; Elliott, Pm; Gorenek, B; Israel, Cw; Leclercq, C; Linde, C; Mont, L; Padeletti, L; Sutton, R; Vardas, Pe
abstract

Resynchronization therapy

2013 - [Appropriateness criteria for the treatment of atrial fibrillation with dronedarone: practical issues. An Italian cardiologists' expert opinion] [Articolo su rivista]
Botto, Giovanni Luca; Capucci, Alessandro; Raviele, Antonio; Boriani, Giuseppe; Brignole, Michele; Calò, Leonardo; Calvi, Valeria; De Ponti, Roberto; De Simone, Antonio; Delise, Pietro; Di Biase, Matteo; Lombardi, Federico; Lunati, Maurizio; Santomauro, Maurizio; Senni, Michele; Stabile, Giuseppe; Themistoclakis, Sakis; Tritto, Massimo; Volpe, Massimo
abstract

Antiarrhythmic agents are among the therapeutic options available for the treatment of atrial fibrillation when a rhythm control strategy is required. Although their efficacy seems to be generally comparable to that of nonpharmacological interventions, the use of these agents remains controversial. In particular, among this class of drugs, the use of dronedarone in clinical practice is a matter of debate. In this paper, the authors aimed to address these issues, involving a team of expert cardiologists who discussed about the potential use of dronedarone in different clinical scenarios. The RAND/UCLA appropriateness method was used to develop appropriateness measures for the optimal management of patients treated with dronedarone, by combining the best available scientific evidence with the collective judgment of experts. To this purpose, a group of experts was identified and asked to rate the benefit-to-harm ratio of 52 clinical scenarios. Each indication was classified as "appropriate", "uncertain" or "inappropriate" in accordance with the panelists' median score. The classification of each scenario has led to the development of several recommendations for clinical practice. The use of dronedarone for the management of paroxysmal and persistent atrial fibrillation has evolved over time: this antiarrhythmic drug appears to be useful not only in monitoring symptoms, but also in reducing hospitalization and mortality rates in patients with atrial fibrillation.

2013 - [The BLOCK HF study] [Articolo su rivista]
Boriani, Giuseppe; Sassone, Biagio
abstract

N/A

2012 - Arrhythmia discrimination by physician and defibrillator: importance of atrial channel. [Articolo su rivista]
Diemberger, I; Martignani, C; Biffi, M; Frabetti, L; Valzania, C; Cooke, Rm; Rapezzi, C; Branzi, A; Boriani, Giuseppe
abstract

BACKGROUND: Many ICD carriers experience inappropriate shocks, but the relative merits of dual- /single-chamber devices for arrhythmia discrimination still remain unclear. We explored possible advantages of the atrial data provided by dual-chamber implantable defibrillators (ICD) for discrimination of real-life supraventricular/ventricular tachyarrhythmias (SVT/VT). METHODS: 100 dual-chamber traces from 24 ICD were blindly reviewed in dual-chamber and simulated single-chamber (with/without discriminator data) reading modes by five electrophysiologists who determined chamber of origin and provided Likert-scale "confidence" ratings. We assessed 1) intra/interobserver concordance; 2) diagnostic accuracy, using expert diagnoses as a reference standard; 3) ROC curves of sensitivity/specificity of "likelihood perception" scores, generated by combining chamber-of-origin diagnostic judgments with Likert-scale "confidence" ratings. We also assessed diagnostic accuracy of automated discrimination by all possible dual-/single-chamber algorithm configurations. RESULTS: Interobserver concordance was "substantial" (modified Cohen kappa-test values for dual-/single-chamber, 0.79/0.68); intraobserver concordance "almost complete" (kappa ≥ 0.89). Dual-chamber mode provided best diagnostic sensitivity/specificity (99%/92%) and highest reader confidence (p<0.001). Area under ROC curves of sensitivity/specificity values for the "likelihood perception" score (representing electrophysiologists' perceptions of the likelihood that an episode was of ventricular origin) was highest in dual-chamber mode (0.98 vs. 0.93 for both single-chamber modes; p<0.001). Regarding automated discrimination, all four dual-chamber configurations conferred 100% sensitivity (specificity values ranged 39%-88%), whereas single-chamber configurations appeared inferior (best sensitivity/specificity combination, 89%/64%). CONCLUSIONS: Availability of the atrial channel helps in reducing inappropriate ICD therapies by providing relevant advantages in terms of both appropriate cardiologist's post-hoc discrimination of SVT/VT (improving program tailoring) and automated arrhythmia discrimination.

2012 - Atrial fibrillation: it is better to be alone than in bad company! [Articolo su rivista]
Boriani, Giuseppe; Diemberger, I; Biffi, M.
abstract

Comment on: Potpara TS, Stankovic GR, Beleslin BD, Polovina MM, Marinkovic JM, Ostojic MC, Lip GY A 12-year follow-up study of patients with newly diagnosed lone atrial fibrillation: implications of arrhythmia progression on prognosis: the Belgrade Atrial Fibrillation study. Chest. 2012 Feb;141(2):339-47. .

2012 - Cardiac resynchronization therapy in heart failure. Doubts and certainties. [Articolo su rivista]
M., Ziacchi; M., Biffi; E., Cervi; C., Martignani; I., Diemberger; A., Marziali; G., Massaro; A., Mazzotti; B., Gardini; Boriani, Giuseppe
abstract

Cardiac resynchronization therapy (CRT) is an effective and useful electrical treatment for appropriately selected heart failure patients with complete left bundle branch block, even for those with mild symptoms. It has been calculated that 3-12% of heart failure patients could benefit from a CRT device. According to the results of a series of trials, biventricular pacing improves quality of life and haemodynamic parameters and this is associated with a reduction in heart failure hospitalizations and mortality. The efficacy of CRT has been proven by a series of randomized controlled studies, and consensus guidelines now give precise recommendations for selecting candidates for CRT not only among patients with moderate to severe heart failure, but also among patients with mild heart failure. Despite some uncertainties concerning a series of issues (selection of candidates, prediction of response, phrenic nerve stimulation, optimization of device programming), CRT is now an accepted treatment for selected patients with heart failure and specific indications are included in consensus guidelines for heart failure treatment. Devices for CRT have a relatively high upfront cost, but when CRT is applied to appropriately selected patients it may be a worthwhile investment not only for our patients but also for our healthcare systems.

2012 - Changes in global longitudinal strain during rest and exercise in patients treated with cardiac resynchronization therapy. [Articolo su rivista]
Valzania, C; Gadler, F; Boriani, Giuseppe; Eriksson, M. J.
abstract

Relatively few data have been reported on prospective changes in global longitudinal strain (GLS) following cardiac resynchronization therapy (CRT), and none are available on GLS during physical exercise. We investigated the effects of CRT on GLS, assessed by speckle tracking two-dimensional (2D) echocardiography, at rest and during exercise after a mid-term follow-up. Twenty consecutive CRT patients (45% ischaemic) were assessed prospectively by speckle tracking 2D echocardiography before implant (at rest) and at mid-term follow-up (during rest and bicycle exercise). GLS, septum and lateral wall longitudinal strain, left ventricular ejection fraction (LVEF), and conventional functional variables were evaluated at baseline and follow-up. All patients completed the study protocol at rest. Exercise images were available in 90% of the patients. At follow-up, GLS improved at rest from -7·1 ± 2·6% to -9·1 ± 4·5% (P<0·01), with a further increase to -11 ± 5·1% during exercise (P<0·001). Longitudinal strain increased at rest both in the septum and in the lateral wall, with an additional increase during exercise in the lateral wall (P<0·05). GLS correlated with LVEF both at rest (r = -0·55 and r = -0·91 at baseline and 3 months, respectively; P<0·05) and during exercise (r = -0·89, P<0·05). Improvement in GLS during rest and exercise can be observed in CRT patients at mid-term follow-up and seems to correlate with changes in LVEF. GLS may be a valuable method to assess left ventricular function during rest and exercise.

2012 - Comprehensive risk reduction in patients with atrial fibrillation: emerging diagnostic and therapeutic options--a report from the 3rd Atrial Fibrillation Competence NETwork/European Heart Rhythm Association consensus conference. [Articolo su rivista]
Kirchhof, P; Lip, Gy; Van Gelder, Ic; Bax, J; Hylek, E; Kaab, S; Schotten, U; Wegscheider, K; Boriani, Giuseppe; Brandes, A; Ezekowitz, M; Diener, H; Haegeli, L; Heidbuchel, H; Lane, D; Mont, L; Willems, S; Dorian, P; Aunes Jansson, M; Blomstrom Lundqvist, C; Borentain, M; Breitenstein, S; Brueckmann, M; Cater, N; Clemens, A; Dobrev, D; Dubner, S; Edvardsson, Ng; Friberg, L; Goette, A; Gulizia, M; Hatala, R; Horwood, J; Szumowski, L; Kappenberger, L; Kautzner, J; Leute, A; Lobban, T; Meyer, R; Millerhagen, J; Morgan, J; Muenzel, F; Nabauer, M; Baertels, C; Oeff, M; Paar, D; Polifka, J; Ravens, U; Rosin, L; Stegink, W; Steinbeck, G; Vardas, P; Vincent, A; Walter, M; Breithardt, G; Camm, A. J.
abstract

While management of atrial fibrillation (AF) patients is improved by guideline-conform application of anticoagulant therapy, rate control, rhythm control, and therapy of accompanying heart disease, the morbidity and mortality associated with AF remain unacceptably high. This paper describes the proceedings of the 3rd Atrial Fibrillation NETwork (AFNET)/European Heart Rhythm Association (EHRA) consensus conference that convened over 60 scientists and representatives from industry to jointly discuss emerging therapeutic and diagnostic improvements to achieve better management of AF patients. The paper covers four chapters: (i) risk factors and risk markers for AF; (ii) pathophysiological classification of AF; (iii) relevance of monitored AF duration for AF-related outcomes; and (iv) perspectives and needs for implementing better antithrombotic therapy. Relevant published literature for each section is covered, and suggestions for the improvement of management in each area are put forward. Combined, the propositions formulate a perspective to implement comprehensive management in AF.

2012 - Cost-effectiveness of cardiac resynchronisation therapy [Articolo su rivista]
Boriani, Giuseppe; I., Diemberger; M., Biffi; C., Martignani
abstract

Cardiac resynchronisation therapy (CRT) is a pacing treatment for heart failure. It was first proposed in the 1990s for selected patients with drug refractory heart failure, on the basis of a series of pioneering experiences performed in France.1 ,2 The pathophysiological background for CRT is the presence, in a substantial subset of heart failure patients, of a left intraventricular conduction delay (wide QRS at 12 lead ECG) with associated left ventricular mechanical dyssynchrony. Stimulation of the left ventricle through an electrode, inserted into the venous system until its tip reaches a posterolateral or lateral branch of the coronary sinus, is able to correct the electrical dyssynchrony, thus improving haemodynamics, exercise performance and the patient's symptoms. In patients with symptomatic improvement, the correction of electrical dyssynchrony (ie, resynchronisation) is usually associated with a reduction in left ventricular volumes (‘reverse remodelling’), a reduction of mitral regurgitation and an improvement in left ventricular ejection fraction.

2012 - Dronedarone: Una reale innovazione o solo una valida seconda scelta? Come districarsi tra linee guida, agenzie regolatorie e pratica clinica quotidiana [Articolo su rivista]
Capucci, A; Guerra, F; Antenucci, C; Antonicelli, R; Bocconcelli, P; Boriani, Giuseppe; Busacca, P; Ciampani, N; Della Casa, S; Gabrielli, D; Galvani, M; Margheri, M; Melandri, F; Modena, Maria Grazia; Perna, Gp; Pieri, P; Piovaccari, G; Pozzolini, A; Rapezzi, C; Villani, Gq
abstract

Dronedarone is the antiarrhythmic drug with the most complete and wide literature preceding its marketing. Most of these studies showed a good efficacy along with an excellent risk profile, especially in low- and medium-risk patients. Recently, updates of European, American and even Italian guidelines gave dronedarone its own spot into the antiarrhythmic armamentarium, recommending its use both for rhythm control and rate control in non-permanent atrial fibrillation. In Italy, however, dronedarone prescription is still possible only when amiodarone is not tolerated, making dronedarone a mere second choice of its older "relative". Moreover, patients taking dronedarone must undergo a strict alanine aminotransferase and bilirubin follow-up, which usefulness in predicting drug-induced liver damage (probably idiosyncratic in nature and therefore unpredictable) is far from demonstrated. The aim of this review is to sum up actual evidences on dronedarone, describe how these evidences had been differently transposed by panel of experts and drug agencies into guidelines and recommendations, and define the current difficulties encountered by the cardiologist in the correct use of this new antiarrhythmic agent in clinical practic

2012 - First prospective, multi-centre clinical experience with a novel left ventricular quadripolar lead [Articolo su rivista]
Sperzel, J; Dänschel, W; Gutleben, Kj; Kranig, W; Mortensen, P; Connelly, D; Trappe, Hj; Seidl, K; Duray, G; Pieske, B; Stockinger, J; Boriani, Giuseppe; Jung, W; Schilling, R; Saberi, L; Hallier, B; Simon, M; Rinaldi, C. A.
abstract

Abstract AIMS: Cardiac resynchronization therapy (CRT) is sometimes complicated by elevated pacing thresholds and phrenic nerve stimulation (PNS), both of which may require that the coronary sinus lead be repositioned. The purpose of this study was to evaluate the performance of a novel quadripolar electrode lead and cardiac resynchronization therapy-defibrillator (CRT-D) device that enables electrical repositioning, potentially obviating a lead reposition procedure. METHODS AND RESULTS: Patients indicated for CRT were enrolled and received a quadripolar electrode lead and CRT-D device (Quartetmodel 1458Q and Promote Q; St Jude Medical, Sylmar, CA, USA). Electrical data, and the presence of PNS during pacing from each left ventricular (LV) configuration, were documented at pre-hospital discharge and at 1 month. Seventy-five patients were enrolled and 71 were successfully implanted with a Quartetlead. Electrical measurements were stable over the follow-up period. Ninety-seven per cent (64 of 66) of patients had one or more programmable configurations with a threshold < 2.5 V and no PNS vs. 86% (57 of 66) if only conventional bipolar configurations were considered. Physicians were able to use the increased programming options to manage threshold changes and PNS. CONCLUSION: The new quadripolar electrode LV lead provides more programming options to address common problems faced when managing CRT patients. Electrical measurements from new vectors are comparable with conventional configurations. Furthermore, 11% of patients in the study suffered PNS on all conventional bipolar vectors

2012 - Globalization of the Epidemiologic, Clinical, and Financial Burden of Atrial Fibrillation [Articolo su rivista]
Boriani, Giuseppe; Igor, Diemberger
abstract

Cost of illness in atrial fibrillation

2012 - How do cardiologists face health economics and health technology assessments? [Articolo su rivista]
Boriani, Giuseppe
abstract

How do cardiologists face health economics and health technology assessments

2012 - Identifying the patient who FADES away prior to appropriate ICD intervention. [Articolo su rivista]
Boriani, Giuseppe; Diemberger, I.
abstract

N/A

2012 - Impact of mitral regurgitation on the outcome of patients treated with CRT-D: data from the InSync ICD Italian Registry. [Articolo su rivista]
Boriani, Giuseppe; Gasparini, M; Landolina, M; Lunati, M; Biffi, M; Santini, M; Padeletti, L; Molon, G; Botto, G; de Santo, T; Valsecchi, S; InSync/InSync ICD Italian Registry, Investigators
abstract

Abstract We assessed the influence of clinically significant mitral regurgitation (MR) on clinical-echocardiographic response and outcome in heart failure (HF) patients treated with a biventricular defibrillator (cardiac resynchronization therapy defibrillator [CRT-D]). METHODS AND RESULTS: A total of 659 HF patients underwent successful implantation of CRT-D and were enrolled in a multicenter prospective registry (median follow-up of 15 months). Following baseline echocardiographic evaluation, patients were stratified into two groups according to the severity of MR: 232 patients with more than mild MR (Group MR+: grade 2, 3, and 4 MR) versus 427 patients with mild (grade 1) or no functional MR (Group MR-). On 6- and 12-month echocardiographic evaluation, MR was seen to have improved in the vast majority of MR+ patients, while it remained unchanged in most MR- patients. On 12-month follow-up evaluation, a comparable response to CRT was observed in the two groups, in terms of the extent of left ventricular reverse remodeling and combined clinical and echocardiographic response. During long-term follow-up, event-free survival did not differ between MR+ and MR- patients, even when subpopulations of patients with ischemic heart disease and with dilated cardiomyopathy were analyzed separately. On multivariate analysis, the only independent predictor of death from any cause was the lack of β-blocker use. CONCLUSIONS: This observational analysis supports the use of CRT-D in HF patients with clinically significant MR; MR had no major influence on patient outcome.

2012 - Improving thromboprophylaxis using atrial fibrillation diagnostic capabilities in implantable cardioverter-defibrillators: the multicentre Italian ANGELS of AF Project [Articolo su rivista]
Boriani, Giuseppe; Santini, M; Lunati, M; Gasparini, M; Proclemer, A; Landolina, M; Padeletti, L; Botto, Gl; Capucci, A; Bianchi, S; Biffi, M; Ricci, Rp; Vimercati, M; Grammatico, A; Lip, Gy
abstract

BACKGROUND: Atrial fibrillation (AF) is a well-established risk factor for stroke and thromboembolism and is a frequent comorbid arrhythmia in patients with implantable cardioverter-defibrillators (ICDs). The Anticoagulation Use Evaluation and Life Threatening Events Sentinels (ANGELS) of AF project was a medical care program aimed at supporting adherence to oral anticoagulation (OAC) guidelines for thromboprophylaxis through the use of ICD AF diagnostics. METHODS AND RESULTS: Fifty Italian cardiology clinics followed 3438 patients with ICDs. In a subgroup of 15 centers (the ANGELS of AF centers), cardiologists attending to follow-up visits were supplied with specific reports describing stroke risk factors and risk scores (American College of Chest Physicians and CHADS(2) [congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, and prior stroke or transient ischemic attack]), AF occurrence and duration, and current antithrombotic therapy for patients with AF, especially those with a CHADS(2) score >0 and not on OAC therapy. The remaining centers represented a control group of patients as a comparison of OAC use. In the ANGELS of AF centers, 709 (36%) patients had AF described either in their clinical history (n=426 [22%]) or as new-onset AF (n=257 [14%]). Among 683 (96%) patients with CHADS2 score >0, 209 (30.6%) were not taking an OAC. Appropriate OAC therapy was prescribed in 10% (22/209) of patients after evaluation of ANGELS of AF reports. The percentage of patients on OAC therapy, as indicated by guidelines, increased during follow-up from 46.1% at baseline, to 69.4% at the stroke risk evaluation phase, to up to 72.6% at the end of the observation period. In control centers, corresponding figures were 46.9% at baseline and 56.8% at the end of the observation period (P<0.001 versus ANGELS of AF group). CONCLUSIONS: The ANGELS of AF project demonstrates the possibility to improve OAC use in accordance with available guidelines for stroke risk reduction in AF by supplying attending physicians with reports about patients risk factors and AF information from continuous ICD monitoring.

2012 - Influence of time between last myocardial infarction and prophylactic implantable defibrillator implant on device detections and therapies. Routine Practice data from the SEARCH MI registry. [Articolo su rivista]
Boriani, Giuseppe; Botto, G; Lunati, M; Proclemer, A; Schmidt, B; Erdogan, A; Rauhe, W; Biffi, M; Santi, E; Becker, D; Messier, M; Santini, M.
abstract

BACKGROUND: A multicenter European Registry, SEARCH-MI, was instituted in the year 2002 in order to assess patients' outcomes and ICD interventions in patients with a previous MI and depressed LV function, treated with an ICD according to MADIT II results. In this analysis, we evaluate the influence of the time elapsed between last myocardial infarction (MI) and prophylactic cardioverter defibrillator (ICD) implant on device activations. METHODS: 643 patients with left ventricular dysfunction (mean LVEF 26 ± 5%) and NYHA class I-III were prospectively followed for 1.8 ± 1.2 years in a multicenter registry. The population was divided into 3 groups according to the time between last MI and ICD implant: [1] from 40 days to less than 1.5 years; [2] from 1.5 to less than 7 years and [3] at least 7 years. RESULTS: The cumulative incidence of ventricular tachyarrhymias and appropriate device therapy (ATP or shock) were higher in patients implanted longer time from last MI (Gray's Test p=0.002 and p=0.013 respectively). No significant differences were seen in all cause mortality (Gray's Test p=0.618) or sudden cardiac death across the MI stratification groups (Gray's Test p=0.663). CONCLUSIONS: Patients implanted with an ICD longer after the MI have a higher chance of presenting ventricular tachyarrhythmias and appropriate ICD therapy, while no differences were seen in overall mortality. These observations may be important for improving patient targeting in sudden death prevention.

2012 - Laminopathies: Many diseases, one gene. Report of the first Italian meeting course on laminopathies [Relazione in Atti di Convegno]
Lattanzi, G; Benedetti, S; Bertini, E; Boriani, Giuseppe; Mazzanti, L; Novelli, G; Pasquali, R; Pini, A; Politano, L.
abstract

non disponibile

2012 - Massive Pulmonary Embolism with Acute Coronary Syndrome-like Electrocardiogram Mimicking Acute Left Main Coronary Artery Obstruction. [Articolo su rivista]
Ciliberti, P; Rapezzi, C; Villani, C; Boriani, Giuseppe
abstract

not available

2012 - Meta-analysis of randomized controlled trials evaluating left ventricular vs. biventricular pacing in heart failure: effect on all-cause mortality and hospitalizations. [Articolo su rivista]
Boriani, Giuseppe; Gardini, B; Diemberger, I; Bacchi Reggiani, Ml; Biffi, M; Martignani, C; Ziacchi, M; Valzania, C; Gasparini, M; Padeletti, L; Branzi, A.
abstract

Aim Randomized controlled trials (RCTs) showed that biventricular (BiV) pacing reduces heart failure (HF) hospitalizations and mortality in patients with New York Heart Association (NYHA) class III-IV HF, left ventricular (LV) dysfunction, and wide QRS. We performed a systematic review and meta-analysis of the RCTs comparing LV-only vs. biventricular (BiV) pacing in candidates for cardiac resynchronization therapy (CRT). METHODS AND RESULTS: The systematic review selected five RCTs (out of 1888 analysed reports) with a cumulative number of 372 patients randomized to BiV pacing and 258 to LV-only pacing. The meta-analysis shows that BiV pacing is not superior to LV-only pacing and that these two pacing modalities do not differ with regard to death or heart transplantation [LV-only vs. BiV pacing odds ratio (OR) 1.24, 95% confidence interval (CI) 0.57-2.70 with the fixed effect model, OR 1.25, 95% CI 0.48-3.24 with the random effect model]. Specific data on hospitalizations were available only in two RCTs with a cumulative number of 127 patients randomized to BiV and 123 to LV-only pacing. The meta-analysis shows that BiV pacing is not superior to LV-only pacing and that these two pacing modalities do not differ with regard to this outcome (LV-only vs. BiV pacing OR 0.86, 95% CI 0.49-1.50 with the fixed effect model, OR 0.86, 95% CI 0.49-1.50 with the random effect model). CONCLUSIONS: Biventricular pacing is not superior to LV-only pacing, and these two pacing modalities appear to achieve similar efficacy in candidates for CRT for moderate to severe HF, in terms of all-cause mortality and hospitalizations during follow-up.

2012 - On the resolution of ECG acquisition systems for the reliable analysis of the P-wave [Articolo su rivista]
Censi, F.; Calcagnini, G.; Corazza, I.; Mattei, E.; Triventi, M.; Bartolini, P.; Boriani, Giuseppe
abstract

The analysis of the P-wave on surface ECG is widely used to assess the risk of atrial arrhythmias. In order to provide reliable results, the automatic analysis of the P-wave must be precise and reliable and must take into account technical aspects, one of those being the resolution of the acquisition system. The aim of this note is to investigate the effects of the amplitude resolution of ECG acquisition systems on the P-wave analysis. Starting from ECG recorded by an acquisition system with a less significant bit (LSB) of 31 nV (24 bit on an input range of 524 mVpp), we reproduced an ECG signal as acquired by systems with lower resolution (16, 15, 14, 13 and 12 bit). We found that, when the LSB is of the order of 128 µV (12 bit), a single P-wave is not recognizable on ECG. However, when averaging is applied, a P-wave template can be extracted, apparently suitable for the P-wave analysis. Results obtained in terms of P-wave duration and morphology revealed that the analysis of ECG at lowest resolutions (from 12 to 14 bit, LSB higher than 30 µV) could lead to misleading results. However, the resolution used nowadays in modern electrocardiographs (15 and 16 bit, LSB <10 µV) is sufficient for the reliable analysis of the P-wave.

2012 - Prophylactic cardioverter defibrillator utilization in the "real world": a conundrum. [Articolo su rivista]
Boriani, Giuseppe; Leyva, F.
abstract

Randomized controlled trials have shown that implantable cardioverter defibrillator (ICD) therapy improves survival in appropriately selected patients with left ventricular dysfunction due to myocardial infarction (MI). Specific recommendations for ICD therapy have been included in consensus guidelines. There is, however, uncertainty as to whether guidelines on prophylactic ICD therapy are being applied in "real world" clinical practice. A report from a tertiary care center in Israel shows that in the period between 2005 and 2009, a prophylactic ICD was implanted in only 14% of post-MI patients in whom it was indicated, according to current guidelines. Importantly, failure to systematically reassess left ventricular function after a MI was linked to underuse of ICDs. Various factors such as differential coverage by health care insurances, patients' decision, physician's evaluation of co-morbidities and age, as well as under-referral to specialized centers may be involved in limiting the use of prophylactic ICDs. The shortfall in ICD implant rate in relation to that expected from current guidelines calls for further integration of healthcare systems.

2012 - QRS pattern and improvement in right and left ventricular function after cardiac resynchronization therapy: a radionuclide study [Articolo su rivista]
Domenichini, G; Burri, H; Valzania, C; Gavaruzzi, G; Fallani, F; Biffi, M; Sunthorn, H; Diemberger, I; Martignani, C; Foulkes, H; Fleury, E; Boriani, Giuseppe
abstract

Predicting response to cardiac resynchronization therapy (CRT) remains a challenge. We evaluated the role of baseline QRS pattern to predict response in terms of improvement in biventricular ejection fraction (EF). METHODS: Consecutive patients (pts) undergoing CRT implantation underwent radionuclide angiography at baseline and at mid-term follow-up. The relationship between baseline QRS pattern and mechanical dyssynchrony using phase analysis was evaluated. Changes in left and right ventricular EF (LVEF and RVEF) were analyzed with regard to baseline QRS pattern. RESULTS: We enrolled 56 pts, 32 with left bundle branch block (LBBB), 4 with right bundle branch block (RBBB) and 20 with non-specific intraventricular conduction disturbance (IVCD). A total of 48 pts completed follow-up. LBBB pts had significantly greater improvement in LVEF compared to RBBB or non-specific IVCD pts (+9.6 ± 10.9% vs. +2.6 ± 7.6%, p = 0.003). Response (defined as ≥ 5% increase in LVEF) was observed in 68% of LBBB vs. 24% of non-specific IVCD pts (p = 0.006). None of the RBBB pts were responders. RVEF was significantly improved in LBBB (+5.0 ± 9.0%, p = 0.007), but not in non-specific IVCD and RBBB pts (+0.4 ± 5.8%, p = 0.76). At multivariate analysis, LBBB was the only predictor of LVEF response (OR, 7.45; 95% CI 1.80-30.94; p = 0.006), but not QRS duration or extent of mechanical dyssynchrony. CONCLUSIONS: Presence of a LBBB is a marker of a positive response to CRT in terms of biventricular improvement. Pts with non-LBBB pattern show significantly less benefit from CRT than those with LBBB.

2012 - Relevance of Monitoring Atrial Fibrillation in Clinical Practice [Articolo su rivista]
Lewalter, Thorsten; Boriani, Giuseppe
abstract

The monitoring of atrial fibrillation (AF) is performed using a variety of tools, ranging from the conventional Holter electrocardiogram to modern implantable loop recording with remote data exchange. The main clinical areas in AF where monitoring is crucial for decision-making are catheter and surgical ablation, as well as anticoagulation to prevent strokes. Identifying the patient cohort at risk - e.g., those with subclinical silent AF - is a challenge. In addition, the interaction of AF with implanted devices - e.g. AF-triggered inadequate shock therapy - should be the object of continuous monitoring. The prevention of inadequate shock delivery in particular is of major clinical importance.

2012 - Short-term onset of fatal pulmonary toxicity in a patient treated with intravenous amiodarone for post-operative atrial fibrillation. [Articolo su rivista]
Boriani, Giuseppe; Ferruzzi, L; Corti, B; Ruffato, A; Gavelli, G; Mattioli, S.
abstract

No abstract available

2012 - The "rope and stick" and the "safety snare": Two new techniques for tricky lead extractions. [Articolo su rivista]
Diemberger, I; Biffi, M; Martignani, C; Ziacchi, M; Boriani, Giuseppe
abstract

not available

2012 - The EHRA White Book. [Articolo su rivista]
Arribas, F; Auricchio, A; Wolpert, C; Merkely, B; Merino, Jl; Boriani, Giuseppe; van der Velde, E; Camm, J; Vardas, P.
abstract

non disponibile

2012 - The empowerment of translational research: lessons from laminopathies [Articolo su rivista]
Benedetti, S; Bernasconi, P; Bertini, E; Biagini, E; Boriani, Giuseppe; Capanni, C; Carboni, N; Cenacchi, G; Columbaro, M; D'Adamo, M; D'Amico, A; D'Apice, Mr; Fontana, M; Gambineri, A; Lattanzi, G; Liguori, R; Maraldi, Nm; Mazzanti, L; Mercuri, E; Mongini, T; Morandi, Lo; Neri, I; Nigro, G; Novelli, G; Ortolani, M; Pasquali, R; Pini, A; Petrini, S; Politano, L; Previtali, S; Pucci, L; Rapezzi, C; Ricci, G; Rodolico, C; Sbraccia, P; Scarano, E; Siciliano, G; Squarzoni, S; Toscano, A; Vercelli, L; Ziacchi, M.
abstract

The need for a collaborative approach to complex inherited diseases collectively referred to as laminopathies, encouraged Italian researchers, geneticists, physicians and patients to join in the Italian Network for Laminopathies, in 2009. Here, we highlight the advantages and added value of such a multidisciplinary effort to understand pathogenesis, clinical aspects and try to find a cure for Emery-Dreifuss muscular dystrophy, Mandibuloacral dysplasia, Hutchinson-Gilford Progeria and forms of lamin-linked cardiomyopathy, neuropathy and lipodystrophy.

2012 - Transcatheter aortic valve implantation with a self-expanding nitinol bioprosthesis: prediction of the need for permanent pacemaker using simple baseline and procedural characteristics. [Articolo su rivista]
Saia, F; Lemos, Pa; Bordoni, B; Cervi, E; Boriani, Giuseppe; Ciuca, C; Taglieri, N; Mariani J., Jr; Filho, Rk; Marzocchi, A.
abstract

To ascertain incidence and predictors of new permanent pacemaker (PPM) following transcatheter aortic valve implantation (TAVI) with the self-expanding aortic bioprosthesis. BACKGROUND: TAVI with the Medtronic Corevalve (MCV) Revalving System (Medtronic, Minneapolis, MN) has been associated with important post-procedural conduction abnormalities and frequent need for PPM. METHODS: Overall, 73 consecutive patients with severe symptomatic AS underwent TAVI with the MCV at two institutions; 10 patients with previous pacemaker and 3 patients with previous aortic valve replacement were excluded for this analysis. Clinical, echocardiographic, and procedural data were collected prospectively in a dedicated database. A standard 12-lead ECG was recorded in all patients at baseline, after the procedure and predischarge. Decision to implant PPM was taken according to current guidelines. Logistic multivariable modeling was applied to identify independent predictors of PPM at discharge. RESULTS: Patients exhibited high-risk features as evidenced by advanced age (mean = 82.1 ± 6.2 years) and high surgical scores (logistic EuroSCORE 23.0 ± 12.8%, STS score 9.4 ± 6.9%). The incidence of new PPM was 28.3%. Interventricular septum thickness and logistic Euroscore were the baseline independent predictors of PPM. When procedural variables were included, the independent predictors of PPM were interventricular septum thickness (OR 0.52; 95% CI 0.32-0.85) and the distance between noncoronary cusp and the distal edge of the prosthesis (OR 1.37; 95% CI 1.03-1.83). CONCLUSIONS: Conduction abnormalities are frequently observed after TAVI with self-expandable bioprosthesis and definitive pacing is required in about a third of the patients, with a clear association with depth of implant and small interventricular septum thickness.

2012 - Winning the war, far, in developing countries. Novel anticoagulants as a new weapon against stroke [Articolo su rivista]
Bronzetti, G. K.; Corzani, A.; D'Angelo, C.; Bonvicini, M.; Gargiulo, G. D.; Boriani, Giuseppe
abstract

I have just returned from an African mission in Zimbabwe. I am now in the university hospital in Bologna where I work. In the waiting room of the anticoagulation therapy center I see a silent mass of people, mostly elderly, waiting for a blood sample to be taken. The expression on the faces of these men and women is generally sad and resigned; I know this ritual well, it can happen from two to four times a month. The queue, the nurse, the needle and the wait for the verdict – INR – that will decide the dose of the medicine to be taken in the evening, a few hours after meals. Meals that in turn are limited by the countless interferences of warfarin/Coumadin, the infamous rat poison that has become a life-saver for heart disease patients. This image takes me back irresistibly to Africa. Some go to Black Africa with their world-class Reflex to look for the “Big Five” on safari, some go with a portable echocardiograph to look for the many “big African hearts” in the improvized clinics between the wards where people are dying of HIV and TBC, as was my case last week. In just a few days I saw around a hundred people with heart disease, some with rheumatic valvulopathy, some with congenital heart disease; I did the follow-up on those who had already been operated on in Italy and screened those scheduled for surgery. The great majority of these patients are being treated with Coumadin due to the presence of a valvular prosthesis or atrial fibrillation. In the last year, among the young cardiopathic patients with valvular disease being followed up there were 6 deaths; in 3 of them the suspected cause was an acute malfunction of the prosthesis and in the other 3 it was stroke (both of these had chronic atrial fibrillation). In all these cases, inappropriate anticoagulant therapy seems to have been the cause of death. It is not difficult to imagine how prohibitive anticoagulant therapy can be in third world countries. The reagent is expensive and the test is inaccessible to most patients, never mind the unreliability of the test results due to laboratory errors; on top of all this lack of compliance and dietary errors complete the disastrous scenario. Finding a drug to replace warfarin would be enormously significant for a number of reasons, including its possible use in developing countries. Dabigatran is an oral anticoagulant which acts by directly and competitively inhibiting thrombin, the “leader” of a class of drugs to which new active ingredients are being added. The RE-LY study (The Randomized Evaluation of Long-Term Anticoagulation Therapy) is a multicentre, prospective, randomized trial that enrolled 18,113 patients with atrial fibrillation (AF) and at least one additional cardiovascular risk factor for stroke. The primary endpoint was the incidence of stroke or thromboembolism [1] and [2]. Other outcomes included mortality myocardial infarct rates. In patients with AF, dabigatran administered at the dose of 110 mg was associated with stroke and systemic embolism rates similar to those observed with warfarin (1.53% dabigatran vs 1.69% warfarin) with a lower rate of severe hemorrhage (2.71% vs 3.36% per year). Dabigatran administered at the dose of 150 mg showed lower rates of stroke and systemic embolism compared to warfarin (1.11% vs 1.69%), with similar rates of major hemorrhage (3.11% dabigatran vs 3.36% warfarin). The rates of major hemorrhage (reduction of hemoglobin by at least 2 g/dl, transfusion of at least 2 packs of blood units or symptomatic bleeding in at least one organ) per year were 3.36% for warfarin, 2.71% for dabigatran 110 mg (p = 0.003) and 3.11% for dabigatran 150 mg (p = 0.31) [3].

2011 - Cardiac resynchronization therapy: a cost or an investment? [Articolo su rivista]
Boriani, Giuseppe; Mantovani, Lorenzo G; Biffi, Mauro; Schalij, Martin J; Martignani, Cristian; Leclercq, Christophe; Bax, Jeroen J; Auricchio, Angelo
abstract

Cost-effectiveness estimates can help optimize use of available financial resources and this is especially relevant for implementation of cardiac resynchronization therapy (CRT), given the high upfront costs and the timescale of expected benefits. All available cost-effectiveness estimates for devices with (CRT-P) or without (CRT-D) a defibrillator are based on results of randomized trials of selected patients, with a relatively brief follow-up. Extrapolation suggests that the cost effectiveness of CRT may become more favourable as time horizons increase. Using a lifetime time horizon and comparison with optimal medical therapy, the cost effectiveness of both CRT-P and CRT-D appears to meet the $50 000/QALY benchmark commonly used for health-care interventions in the USA, as well as similar thresholds used in Europe. The absence of direct comparisons of the efficacy/effectiveness of CRT-P and CRT-D hampers cost-effectiveness comparisons, and so clinical judgment in the context of current evidence supporting the benefits of cardioverter-defibrillators may provide a rational basis for choosing between CRT-P and CRT-D. Efforts are currently being dedicated to improve CRT response rates by improved patient selection and, reasonably, any improvement in this field will translate into improved effectiveness, and therefore into improved cost effectiveness. The extended longevity of CRT devices will also positively impact cost-effectiveness estimates.

2011 - Cardiovascular Centers Participating in the ClinicalService Project. Long-term complications related to biventricular defibrillator implantation: rate of surgical revisions and impact on survival: insights from the Italian Clinical Service Database. [Articolo su rivista]
Landolina, M; Gasparini, M; Lunati, M; Iacopino, S; Boriani, Giuseppe; Bonanno, C; Vado, A; Proclemer, A; Capucci, A; Zucchiatti, C; Valsecchi, S; Ricci, Rp; Santini, M.
abstract

Background: Long-term data on device-related untoward events in patients receiving defibrillators for resynchronization therapy (CRT-D) are lacking. We quantified the frequency of repeat invasive procedures and the nature of long-term complications in current clinical practice and examined possible predictors of device-related events and their association with long-term patient outcome. Methods and results: We analyzed data from 3253 patients who underwent de novo successful implantation of CRT-D and were followed up for a median of 18 months (25th to 75th percentiles: 9 to 30) in 117 Italian centers. Device-related events were reported in 416 patients, and, specifically, surgical interventions for system revision were described in 390 patients. Four years after the implantation procedure, 50% of patients underwent surgical revision for battery depletion and 14% for unanticipated events. For comparison, at 4 years battery depletion occurred in 10% and 13% of patients who received single- and dual-chamber defibrillators at the study centers, and unanticipated events were reported as 4% and 9%, respectively. In CRT-D, infections occurred at a rate of 1.0%/y, and the risk of infections increased after device replacement procedures (hazard ratio, 2.04; 95% confidence interval, 1.01 to 4.09; P=0.045). Left ventricular lead dislodgements were reported at a rate of 2.3%/y and were predicted by longer fluoroscopy time and higher pacing threshold on implantation. Device-related events were not associated with a worse clinical outcome; indeed, the risk of death was similar in patients with and without surgical revision (hazard ratio, 0.90; 95% confidence interval, 0.56 to 1.47; P=0.682). XSConclusions: In current clinical practice device-related events are more frequent in CRT-D than in single- or dual-chamber defibrillators, and are frequently managed by surgical intervention for system revision. However, a worse clinical outcome is not associated with these events.

2011 - Changes in exercise capacity induced by heart transplantation: prognostic and therapeutic implications. [Articolo su rivista]
Grigioni, F; Specchia, S; Maietta, P; Potena, L; Bacchi Reggiani, Ml; Ghetti, G; Boriani, Giuseppe; Foschi, E; Corazza, I; Ionico, T; Magnani, G; Zannoli, R; Tentoni, C; Branzi, A.
abstract

Survival and exercise performance are key targets of heart transplantation (HT). We designed this study to help in identifying (1) patients with chronic heart failure (CHF) at risk of poor exercise capacity after HT and (2) HT recipients presenting risk factors modifiable with exercise showing a potential impact on outcome. We enrolled 49 HT recipients (age 52 ± 12 years, 84% males) who underwent a cardiopulmonary exercise test before (9 ± 6 months) and after (20 ± 14 months) HT. In the CHF phase, lower peak oxygen consumption (V̇O 2) (odds ratio 0.69, P=0.017) independently predicted peak V̇O 2 improvement after HT. In the post-HT phase, body mass index (BMI) [adjusted hazard ratio (HR) 1.16, P=0.034] and V̇E (ventilation)/V̇CO 2 (carbon dioxide production) slope (adjusted HR 1.07, P=0.031) independently predicted mortality. In conclusion, CHF patients with only a moderate impairment of peak V̇O 2 are at a risk of failing to achieve a significant improvement of exercise performance after HT. In the post-HT phase, a BMI≥28 and/or a V̇E/V̇CO 2 slope ≥47 represent risk factors for death, which are potentially modifiable with exercise. Prospective randomized studies are needed to analyze the effects of training on functional capacity and outcome in the different subsets of HT recipients.

2011 - Clinical management of atrial fibrillation: need for a comprehensive patient-centered approach. [Articolo su rivista]
Boriani, Giuseppe; Cervi, E; Diemberger, I; Martignani, C; Biffi, M.
abstract

not available

2011 - Comparison of the usefulness of cardiac resynchronization therapy in three age-groups (<65, 65-74 and ≥75 Years) (from the InSync/InSync ICD Italian Registry) [Articolo su rivista]
Fumagalli, S; Valsecchi, S; Boriani, Giuseppe; Gasparini, M; Landolina, M; Lunati, M; Padeletti, M; Tronconi, F; Marchionni, N; Padeletti, L.
abstract

Chronic heart failure is one of the most important geriatric syndromes, associated with disability, increased hospital admissions, and high mortality. The aim of this study was to evaluate the existence of age-related differences in clinical effectiveness and outcomes of cardiac resynchronization therapy (CRT), alone or in combination with an implantable cardioverter-defibrillator (CRT-D), in a large, real-world registry. A total of 1,787 patients admitted for CRT or CRT-D to the 117 centers participating in the InSync/InSync ICD Italian Registry from 1999 to 2005 were evaluated. Patients were divided into 3 age groups: <65 years (n = 571), 65 to 74 years (n = 740), and ≥75 years (n = 476). The left ventricular ejection fraction did not differ in the 3 groups (26 ± 8% vs 26 ± 7% vs 27 ± 8%, p = 0.123). Atrial fibrillation prevalence demonstrated an age-related increase. The use of recommended medical therapy for chronic heart failure decreased with age, as well as CRT-D implantation (p <0.001). The percentage of echocardiographic responders to CRT was similar in the 3 groups, and New York Heart Association class significantly improved independent of age. During the follow-up period (19 ± 13 months), all-cause mortality was higher in patients aged ≥75 years than in those aged <65 years (p = 0.005). In the whole population, mortality was associated with the nonresponder condition, the presence of atrial fibrillation and the lack of prescription of recommended medical therapy. In conclusion, CRT improved left ventricular performance and functional capacity independent of age. The proportion of the responder condition to CRT was the same in all groups. Pharmacologic undertreatment is an important issue in a "real-world" geriatric population

2011 - Comprehensive risk reduction in patients with atrial fibrillation: Emerging diagnostic and therapeutic options. Executive summary of the report from the 3rd AFNET/EHRA consensus conference. [Articolo su rivista]
Kirchhof, P; Lip, Gy; Van Gelder, Ic; Bax, J; Hylek, E; Kääb, S; Schotten, U; Wegscheider, K; Boriani, Giuseppe; Ezekowitz, M; Diener, H; Heidbuchel, H; Lane, D; Mont, L; Willems, S; Dorian, P; Vardas, P; Breithardt, G; Camm, A. J.
abstract

There are exciting new developments in several areas of atrial fibrillation (AF) management that carry the hope of improving outcomes in AF patients. This paper is an executive summary that summarises the proceedings from the 3 rd AFNET/EHRA consensus conference on atrial fibrillation, held in Sophia Antipolis from November 7 th to 9 th 2010, shortly after the release of the new ESC guidelines on AF. The conference was jointly organised by the German Atrial Fibrillation competence NETwork (AFNET) and the European Heart Rhythm Association (EHRA). This executive summary report covers four sections: 1. Risk factors and risk markers for AF, 2. Pathophysiological classification of AF, 3. Relevance of monitored AF duration for AF-related outcomes, and 4. Perspectives and needs for implementing better antithrombotic therapy

2011 - Device therapy and hospital reimbursement practices across European countries: a heterogeneous scenario. [Articolo su rivista]
Boriani, Giuseppe; Burri, H; Mantovani, Lg; Maniadakis, N; Leyva, F; Kautzner, J; Lubinski, A; Braunschweig, F; Jung, W; Lozano, If; Fattore, G.
abstract

As in other settings, in the field of clinical use of cardiac implantable electrical devices (CIEDs), the implementation, in various ways, of diagnosis-related groups (DRGs) has created new scenarios in most European healthcare systems. A DRG system is primarily a financial tool with the aim of promoting efficiency and improving utilization of resources. However, there are a variety of ways in which this system is used for funding the activity of centres implanting CIEDs. It is possible that the specific type and method of reimbursement may influence the implementation of CIEDs in the 'real world' through a variable spectrum of practices. These may range from the situation where reimbursement may, together with other factors, constitute a true barrier to the implementation of guidelines, to scenarios where reimbursement is adequate, and/or to situations where reimbursement may be adequate for standard devices but not for prompt implementation of effective technological innovations. The variety in reimbursement also affects how in-office checks of CIEDs are covered and, above all, the possibility to pay for remote follow-up of CIEDs. In the field of medical devices, refinement of DRG systems and adoption of new strategies and policies are needed to sustain and enhance those effective technological innovations that may be beneficial for specific patient populations. It is also important that physicians are deeply involved in the development and deployment of DRGs, and that each country DRGs agency has a transparent approach to engagement with stakeholders, along with robust and transparent mechanisms for updating these systems.

2011 - Device-detected atrial tachyarrhythmias predict adverse outcome in real-world patients with implantable biventricular defibrillators. [Articolo su rivista]
Santini, M; Gasparini, M; Landolina, M; Lunati, M; Proclemer, A; Padeletti, L; Catanzariti, D; Molon, G; Botto, Gl; La Rocca, L; Grammatico, A; Boriani, Giuseppe
abstract

Objectives The purpose of this analysis was to evaluate the correlation between atrial tachycardia (AT) or atrial fibrillation (AF) and clinical outcomes in heart failure (HF) patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D). Background In HF patients, AT and AF have high prevalence and are associated with compromised hemodynamic function. Methods Forty-four Italian cardiological centers followed up 1,193 patients who received a CRT-D according to current guidelines for advanced HF, New York Heart Association functional class <II, left ventricular ejection fraction ≤35%, and QRS complex <120 ms. All patients were in sinus rhythm at implant. Results During a median follow-up period of 13 months, AT/AF >10 min occurred in 361 of 1,193 (30%) patients. The composite end point (deaths or HF hospitalizations) occurred in 174 of 1,193 (14.6%). Multivariate time-dependent Cox regression analyses showed that composite end point risk was higher among patients with device-detected AT/AF (hazard ratio [HR]: 2.16, p = 0.032), New York Heart Association functional class III or IV compared with II (HR: 2.09, p = 0.002), and absence of beta-blockers (HR: 1.36, p = 0.036). Furthermore, the composite end point risk was inversely associated with left ventricular ejection fraction (HR: 1.04, p = 0.045), increasing by a factor of 4% for each 1% decrease in left ventricular ejection fraction. Conclusions In HF patients with CRT-D, device-detected AT/AF is associated with a worse prognosis. Continuous device diagnostics monitoring and Web-based alerts may inform the physician of AT/AF occurrences and identify patients at risk of cardiac deterioration or patients with suboptimal rate or rhythm control. (Italian ClinicalService Project; NCT01007474

2011 - Economic evaluation in cardiology. [Articolo su rivista]
Maniadakis, N; Vardas, P; Mantovani, Lg; Fattore, G; Boriani, Giuseppe
abstract

For a variety of reasons, the demand and supply of healthcare services is changing daily and expenditure on healthcare services is increasing with rates well above those of the gross domestic product in most countries, regardless of geography, economic development, and population health status. As resources are scarce, it is necessary to ensure that they are allocated in uses that maximize overall health societal benefit. Economic evaluation of healthcare technologies and interventions is a tool designed to assist decision makers in allocating budgets in ways that will maximize value for money spent. This paper explains the economic approach from the perspective of cardiology

2011 - Effects of cardiac resynchronisation therapy on dilated cardiomyopathy with isolated ventricular non-compaction. [Articolo su rivista]
Bertini, M; Ziacchi, M; Biffi, M; Biagini, E; Rocchi, G; Martignani, C; Ferlito, M; Pasquale, F; Cervi, E; Branzi, A; Rapezzi, C; Boriani, Giuseppe
abstract

Objective: To compare the effects of cardiac resynchronisation therapy (CRT) on left ventricular (LV) reverse remodelling in patients with dilated cardiomyopathy (DCM) associated or not with isolated ventricular non-compaction (IVNC). Methods and results: 52 patients with heart failure, candidates for CRT, were recruited: 20 patients with IVNC associated with DCM (IVNC-DCM) without other coexisting cardiac diseases and 32 patients with DCM without IVNC matched for age, gender, body surface area and LV systolic function. Standard and contrast echocardiography were used to assess LV volumes and function and to optimise visualisation of the endocardial border at baseline and at 6 months' follow-up. Patients with heart failure were subsequently classified as CRT negative responders, non-responders, responders or super-responders based on different LV reverse remodelling 6 months after CRT implantation. Different types of CRT response were observed in IVNC-DCM and DCM patients. In particular, in IVNC-DCM patients the percentage of super-responders was significantly higher than for patients with DCM (60% vs 28%, respectively, p=0.023). In addition, the number of IVNC segments had a trend towards reduction with respect to baseline (4 (3-6)) at 6 months' follow-up (3 (1-5); p=0.067). Finally, in IVNC-DCM, the patients with a higher number of IVNC segments at baseline (>4) were more likely to be responders or super-responders than patients with ≤4 IVNC segments (p=0.003). Conclusions: Patients with IVNC-DCM had greater LV reverse remodelling after CRT than patients with DCM. The greater the area of non-compaction (higher number of IVNC segments) the greater the chance of achieving CRT response and greater LV reverse remodelling.

2011 - Effects of cardiac resynchronization therapy on myocardial contractile reserve during exercise. [Articolo su rivista]
Valzania, C; Gadler, F; Boriani, Giuseppe; Eriksson, Mj
abstract

AimsMyocardial contractile reserve (MCR) is a marker of myocardial viability. The impact of cardiac resynchronization therapy (CRT) on MCR during exercise has been little studied. Our aim was to investigate the effects of CRT on global and regional MCR by exercise echocardiography.Methods and resultsTwenty-seven CRT responders (56 ischaemic) were assessed by echocardiography during rest and bicycle exercise. Images were acquired during spontaneous rhythm ('off) and active CRT ('on). Global MCR was expressed as the change (Δ) in left ventricular ejection fraction (LVEF) and aortic velocity-time integral (VTI) from rest to exercise. Regional MCR was expressed as the change in peak systolic tissue velocity (Sm) of the septum and lateral wall. Left ventricular ejection fraction and aortic VTI increased at 'on during rest and exercise, and the increase in global MCR during exercise was higher during 'on than 'off (Δ LVEF 6 ± 6 vs. 3 ± 3; P 0.009). Septum Sm increased during 'on at rest, and it was still higher during exercise (P≤ 0.01), although the absolute change from rest to exercise was similar during 'on and 'off. Lateral wall Sm did not change at rest during 'on, but basal lateral wall MCR during exercise was higher at 'on than 'off (P 0.036).ConclusionIn CRT responders, there is a pacing-dependent increase in global MCR during exercise. The changes in regional MCR of the septum and lateral wall show different patterns. These factors may help to understand the determinants of improved exercise tolerance in CRT responders

2011 - Excimer laser lead extraction by femoral approach. [Articolo su rivista]
Diemberger, I; Biffi, M; Martignani, C; Boriani, Giuseppe
abstract

Despite the latest improvements in pacemaker/defibrillator lead extraction techniques, this procedure may be hindered by specific problems related to patient/lead characteristics. We report the case of a 67-year-old man with a single-chamber implantable defibrillator (ICD) with a malfunctioning right ventricular (RV) defibrillating lead, referred for lead extraction. During extraction of the defibrillating electrode, the added sensing/pacing RV lead suddenly manifested an inapparent fracture with migration within the superior vena cava. Lead extraction through a superior conventional and laser-assisted approach was ineffective. The use of the laser sheath through the femoral approach allowed complete removal of the migrated lead and reimplantation of a new ICD lead

2011 - From lead management to implanted patient management: indications to lead extraction in pacemaker and cardioverter-defibrillator systems [Articolo su rivista]
Diemberger, I; Biffi, M; Martignani, C; Boriani, Giuseppe
abstract

Abstract Based on the published results primarily from cohort studies, percutaneous lead extraction is now considered a safe procedure and indications for its use have broadened from device-related infections to less strict indications, such as recurrent isolated bacteremia, asymptomatic upper vein occlusion and malfunctioning/redundant leads. Almost 50% of electrophysiologists consider lead extraction in these latter situations. To broaden its implementation, further prospective evaluation against conservative approaches is still needed. Rather than only aiming at short-term results, this technique should be integrated into wide-ranging tailored long-term strategies to manage all of the different issues of implanted patients

2011 - Health economics and the European Heart Rhythm Association. [Articolo su rivista]
Vardas, P; Boriani, Giuseppe
abstract

The management of healthcare is becoming extremely complex in developed countries, as a result of increasing age of the population and increasing costs of care, coupled with diminishing resources due to global financial crisis. This situation threatens access to appropriate care, and a more or less explicit rationing of some types of treatment may occur in 'real world' clinical practice. This is particularly true for those treatments or interventions with a relatively high up-front cost, such as cardioverter defibrillators, devices for cardiac resynchronization therapy or ablation procedures for atrial fibrillation. The European Heart Rhythm Association (EHRA) is strongly convinced that the skills of electrophysiologists and cardiologists responsible for the management of rhythm disorders have to evolve, also embracing the knowledge of health economics, clinical epidemiology, health-care management and outcome research. These disciplines do not belong to what is considered as the conventional cultural background of physicians, but knowledge of comparative cost effectiveness and of other economic approaches nowadays appears fundamental for a dialogue with a series of stakeholders, such as policy makers, politicians, and administrators, involved in budgeting the activity of hospitals and health-care services, as well as in approaching health technology assessment

2011 - Health technology assessment: what is it? Current status and perspectives in the field of electrophysiology. [Articolo su rivista]
Fattore, G; Maniadakis, N; Mantovani, Lg; Boriani, Giuseppe
abstract

Health technology assessment (HTA) is the multidisciplinary field of policy analysis that studies medical, social, ethical, and economic implications of the development, diffusion, and use of health technologies. Its worldwide diffusion needs to be understood in the context of evidence-based healthcare delivery policy, and it is strongly driven by the search for new cost-containment policies by the governments of universal healthcare systems. This article presents the three main pillars of HTA: evaluating comparative effectiveness, cost-effectiveness, and organizational impact. While comparative analysis is more familiar to cardiologists, cost-effectiveness and organizational studies are less widely known because they expand the perspective of the evaluation to institutional settings and society at large and require significant inter-disciplinary work. Sound economic and organizational studies that extend comparative effectiveness studies may facilitate dialogue between medical science and policymaking.

2011 - Healthcare personnel resource burden related to in-clinic follow-up of cardiovascular implantable electronic devices: a European Heart Rhythm Association and Eucomed joint survey. [Articolo su rivista]
Boriani, Giuseppe; Auricchio, A; Klersy, C; Kirchhof, P; Brugada, J; Morgan, J; Vardas, P.
abstract

Aims: A pilot European survey was conducted to assess the cumulative time spent by healthcare personnel for in-office follow-up of cardiac implantable electrical devices (CIEDs), including cardiac pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy (CRT) devices. Methods and results: Resource use data were collected during a session of in-clinic follow-up. Among 407 visits, 93 were scheduled and 7 unscheduled. Visit duration (total cumulative time) lasted a mean of 27 min for scheduled visits, and was ∼30 longer for unscheduled visits. Independent determinants of visit duration were: unscheduled visit (7.6 min, P 0.01), the need for device reprogramming (7.5 min, P < 0.001), and the type of device checked, with CRT devices needing 9.1 and 6.6 more minutes than single- (P < 0.001) and dual-chamber devices (P 0.002), respectively. Most visits involved two different types of healthcare personnel (239 of 407, 59), simultaneously. The most frequent combination was the involvement of both a cardiologist and a nurse (216 of 407 visits with both of them only, and 65 additional visits with also an internal technician, an external technician, or both). Overall, an external technician was involved in 18 of visits. Conclusions: In 'real-world' practice, the follow-up of CIEDs nowadays requires important resources in terms of time dedicated by specialized personnel, corresponding to cardiologists, nurses, internal technicians, and external, industry-employed technicians. These observations should be the basis for addressing clinical, organizational, financial, and policy initiatives targeted to optimize follow-up procedures in order to face the increase in the number of patients treated with CIEDs expected for the next years

2011 - How to truly value implantable cardioverter-defibrillators technology: Up-front cost or daily cost? [Articolo su rivista]
Biffi, M; Ziacchi, M; Bertini, M; Gardini, B; Mazzotti, A; Massaro, G; Martignani, C; Diemberger, I; Boriani, Giuseppe; Corsini, D.
abstract

Background: We calculated the daily cost of implantable cardioverter-defibrillators (ICDs) based on their actual longevity to prove whether the up-front cost is a reliable parameter for the ICD purchasing-process. Methods. Longevity of single chamber (SC), double chamber (DC), and biventricular (BiV) ICDs from Medtronic (MDT), Guidant (GDT), and St. Jude Medical (SJM) was measured in all the patients implanted in years 2000, 2001, 2002 who reached device replacement within December 31, 2009. The cost of each ICD (device + lead/s) was normalized for its own longevity. Data are expressed as median (25th-75th percentile). Results: A total of 123/153 patients completed the study, 70 percent being alive 8 years after implantation. MDT devices had a superior longevity compared with GDT and SJM (p <.001). Fifty-eight percent of replaced ICDs had a service life at least 1 year shorter than the manufacturers' prediction. Longer-lasting devices had a significantly lower daily cost: €4.8 (4.6-5.7) versus €6.8 (6.2-9.2) and €6.9 (6.2-7.6) for SC (p <.001); €6.9 (6.8-7.7) versus €12.6 (11.8-13.3) and €13.4 (10.3-16.1) for DC; €8.5 (8.3-10.3) versus €15.4 (15.1-15.8) and €14.6 (14.1-14.9) for BiV (p <.005). Conclusions: The true cost of ICD treatment is strictly dependent on device longevity, whereas device up-front cost is unreliable. This aspect should be valued in the technology purchasing process, and could set the basis for an outcome-based reimbursement system. Our observations may be the benchmark respectively for ICD longevity and daily ICD cost in future comparisons. Independent observations in the real-life scenario are needed to properly value newer technologic improvements

2011 - Improving stroke risk stratification using the CHADS2 and CHA2DS2-VASc risk scores in patients with paroxysmal atrial fibrillation by continuous arrhythmia burden monitoring. [Articolo su rivista]
Boriani, Giuseppe; Botto, Gl; Padeletti, L; Santini, M; Capucci, A; Gulizia, M; Ricci, R; Biffi, M; De Santo, T; Corbucci, G; Lip, Gy; Italian AT 500 Registry, Investigators
abstract

Background And Purpose- In patients with atrial fibrillation (AF), stroke risk stratification schema do not consider AF parameters. The aim of the study is to assess the impact of combining risk factors with continuous AF burden monitoring. Methods- In this retrospective study 568 patients implanted with a DDDR-P pacemaker (AT-500; Medtronic) and a history of AF were continuously monitored for 1 year. Results- During follow-up, 14 patients (2.5%) had a thromboembolic event. Patients were divided into 3 groups: AF burden ≤5 minutes per day (AF-free; n=223 [39%]), AF burden >5 minutes but <24 hours per day (AF-5 minutes; n=179 [32%]), and AF burden 24 hours (AF-24 hours; n=166 [29%]). Patients were also classified according to CHADS2 and CHA2DS2-VASc risk scores. The discrimination ability of each risk score was evaluated performing a logistic regression analysis and calculating the corresponding C-statistic. The addition of AF burden improved C-statistics: for CHADS2 from 0.653 (P=0.051) to 0.713 (P=0.007); for CHA2DS2-VASc, from 0.898 (P<0.0001) to 0.910 (P<0.0001). Conclusions- The CHA2DS2-VASc score had a high sensitivity to predict thromboembolism. Implementation of device data on AF presence/duration/burden has the potential to contribute to improved clinical risk stratification and should be tested prospectively.

2011 - Incidence and clinical relevance of uncontrolled ventricular rate during atrial fibrillation in heart failure patients treated with cardiac resynchronization therapy. [Articolo su rivista]
Boriani, Giuseppe; Gasparini, M; Landolina, M; Lunati, M; Proclemer, A; Lonardi, G; Iacopino, S; Rahue, W; Biffi, M; Distefano, P; Grammatico, A; Santini, M.
abstract

Aims Uncontrolled ventricular rate (VR) during atrial fibrillation (AF) may cause clinical deterioration in heart failure (HF) patients who need continuous biventricular pacing to achieve cardiac resynchronization therapy (CRT). We aimed at evaluating the association between AF, uncontrolled VR, and sub-optimal CRT, defined as low biventricular pacing percentage (BIVP). Methods and results All 1404 patients had HF, New York Heart Association (NYHA) ≥II, left ventricular ejection fraction (LVEF) ≤35, and QRS ≥120 ms, and received an implantable CRT defibrillator (CRT-D). Occurrence of AF, VR during AF and lifetime BIVP were estimated from device data. Ventricular rate during AF was defined as uncontrolled in patients with mean VR>80 bpm and maximum VR>110 bpm. Over a median follow-up of 18 months, AF was detected in 443 of 1404 patients (32). In this sub-group of AF patients, VR during AF was uncontrolled in 150 of 443 patients (34). Multivariate Cox regression analysis showed that age [hazard ratio (HR) 1.03, 95 confidence interval (CI) 1.001.06, P 0.028], and uncontrolled VR [HR 1.69 (CI 1.012.83), P 0.046] were the only independent predictors of clinical outcome, assessed by HF hospitalizations and death. The median lifetime BIVP was 95 (2575 percentile range 9199). Biventricular pacing percentage was significantly and inversely correlated to VR, decreasing by 7 for each 10 bpm increase in VR. Sub-optimal CRT, defined as BIVP <95, was predicted by the occurrence of persistent or permanent AF [odds ratio (OR) 3.77, CI 2.445.82, P< 0.001], and uncontrolled VR [OR 2.25, CI 1.353.73, P 0.002]. Conclusion Uncontrolled VR occurs in one-third of CRT-D patients, who experience AF, and is associated with HF hospitalizations and death and with sub-optimal CRT (lifetime BIVP<95)

2011 - Linee guida AIAC all'impianto di pacemaker, dispositivi per la resincronizzazione cardiaca, defibrillatori automatici e loop recorder. Update 2011. [Articolo su rivista]
Lunati, M; Santini, M; Bongiorni, Mg; Boriani, Giuseppe; Cappato, R; Corrado, D; Curnis, A; Dibiase, M; Favale, S; Padeletti, L; Pedretti, R; Proclemer, A; Ricci, R; Spirito, P; Vergara, G.
abstract

Aggiornamento linee guida AIAC

2011 - Long-term RV threshold behavior by automated measurements: safety is the standpoint of pacemaker longevity! [Articolo su rivista]
Biffi, M; Bertini, M; Mazzotti, A; Gardini, B; Mantovani, V; Ziacchi, M; Valzania, C; Martignani, C; Diemberger, I; Boriani, Giuseppe
abstract

Background: We studied long-term right ventricular (RV) pacing threshold (RVPT) behavior in patients consecutively implanted with pacemakers capable of automatic output reprogramming tracked by automatic RV threshold measurement (automatic verification of capture [AVC]). Methods: All the patients had state-of-the art steroid-eluting bipolar pacing leads and were RV-paced by an AVC algorithm from the three American manufacturers. Follow-up occurred twice in the first year after implantation, then yearly until approaching elective replacement indicator. Results: Three hundred and twenty-one patients aged 73 ± 12 years were observed for 49 ± 26 months on average. At implantation, RVPT was 0.54 ± 0.2 V at 0.4 ms at an average 774 ± 217 Ω impedance. Forty-one of the 321 patients (12.8%) had a permanent RVPT increase above 1.5 V at 0.4 ms: RVPT was between 1.6 and 2.5 V in 29 of 321 (9%) patients, whereas it was between 2.6 and 3.5 V in seven of 321 (2.2%) patients, and >3.5 V in five of 321 (1.5%) patients. No exit block occurred because of automatic RV output adjustment by AVC algorithms. No predictor of RVPT increase was found at multivariable analysis. The maximum RVPT increase occurred within 12 months from implantation in 19 of 321 (5.9%) patients, between the first and the second year in 12 of 321 (3.7%), between the second and the sixth year in eight of 321 (2.5%), and after the sixth year in two of 321 (0.6%). Conclusion: Despite technologic improvement in lead manufacturing, long-term increase of the RVPT occurs in about 13% of patients, possibly representing a serious safety issue in 3.7% when 2.5 V at 0.4 ms is exceeded. AVC algorithms can improve patients' safety by automatic tailoring of the pacing output to threshold fluctuations, while maximizing device longevity

2011 - Management of Phrenic Stimulation in CRT Patients over the Long Term: Still an Unmet Need ? [Articolo su rivista]
Biffi, M; Bertini, M; Ziacchi, M; Gardini, B; Mazzotti, A; Massaro, G; Diemberger, I; Martignani, C; Valzania, C; Boriani, Giuseppe
abstract

Background: Phrenic stimulation (PS) may cause intolerable symptoms and prevent CRT delivery in 2-5% of patients. We sought to ensure effective cardiac resynchronization therapy (CRT) delivery by management of PS at the left ventricular (LV) target site. Methods and Results: Two hundred and eleven consecutive patients received a CRT device despite PS occurrence at the LV target site at implantation, when a PS-LV difference >2V was achieved by LV stimulation programming (cathode, pacing vector). PS management strategy both at implantation and at follow-up (FU) aimed to keep the target LV implantation site. LV reverse remodeling was assessed by echocardiography before implantation and at follow-up. LV lead placement was lateral/posterolateral in all the 211 patients; 51 of 211 had detectable PS at FU, 26 of 211 (12.3%) were symptomatic. Symptoms occurred more frequently when PS-LV difference was <3V (16/16 vs 10/35, P < 0.001). Cathode and pacing vector reprogramming improved the PS-LV difference and symptoms in 14 of 23 patients. LV output as threshold +0.5V was helpful to manage PS symptoms in patients with a PS-LV ≤2V at FU. Median FU was 34.9 (16-50) months: 12 patients had tolerable PS symptoms, 76% (39/51) were objective responders at echocardiography compared to 74% (119/160) in patients without PS (P = NS). Conclusions: CRT delivery at long term is feasible despite PS at the target LV site. PS management is mandatory in about 12.3% of patients at FU, with 6.6% remaining symptomatic. Symptoms improve at FU when a PS-LV >3V is achieved. Further improvement in lead manufacturing and pacing electronics are awaited to meet this clinical need

2011 - Measuring P-wave morphological variability for AF-prone patients identification [Relazione in Atti di Convegno]
Villani, Valeria; Fasano, Antonio; Vollero, Luca; Censi, Federica; Boriani, Giuseppe
abstract

Atrial fibrillation is the most common arrhythmia encountered in clinical practice. Abnormal P-waves have been observed in patients prone to AF and the analysis of P-waves from surface electrocardiogram has been extensively used to identify patients prone to atrial arrhythmias. Measuring the temporal variability of P- waves, i.e., the variation over time of morphological characteristics of single P-waves, may represent a useful method for characterizing and predicting AF cases. In this paper, we propose a method for the statistical analysis of P-waves variability. It is based on the evaluation of the empirical distribution function of differences energy among normalized P-waves. The proposed method seems promising for capturing atrial anomalies and identifying patients prone to AF.

2011 - Peri-operative management of patients taking antithrombotic therapy: need for an integrated proactive approach. [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Diemberger, I; Cervi, E; Martignani, C.
abstract

not available

2011 - Phrenic stimulation management in CRT patients: are we there yet? [Articolo su rivista]
Biffi, M; Boriani, Giuseppe
abstract

PURPOSE OF REVIEW: Phrenic stimulation may hinder left-ventricular (LV) stimulation and prevent cardiac resynchronization therapy (CRT) delivery. We reviewed the literature to address its prevalence and clinical implications in CRT patients. RECENT FINDINGS: Phrenic stimulation prevalence ranges from 20 to 33% of patients when a posterolateral LV lead placement is aimed. False-negatives are common during implantation, sensitivity being about 60-80%. Symptoms may dictate repositioning the LV lead, meaning risk of lead dislodgement, decreased CRT efficacy, or high LV threshold. CRT turn-off occurred in 2% of patients because of refractory phrenic stimulation. Several strategies have been used to manage phrenic stimulation: whereas lead repositioning was the only one available in early CRT experience, the use of bipolar/multipolar leads combined with cathode programmability enabling several pacing configurations has made possible targeting the optimal LV pacing sites in nearly all patients.Despite technological improvements, phrenic stimulation symptoms are sporadically reported by 6-8% of patients at follow-up, meaning that there is still an unmet need to address this problem. SUMMARY: Phrenic stimulation needs to be carefully managed at implantation and follow-up. Use of bipolar/multipolar leads and of multiple pacing configurations is mandatory to increase the chances of managing phrenic stimulation. Active fixation LV leads, hopefully bipolar, could further increase the success rate.

2011 - QT interval shortening in spontaneous reports submitted to the FDA: the need for consensus [Articolo su rivista]
Raschi, E; Poluzzi, E; Koci, A; Boriani, Giuseppe; De Ponti, F.
abstract

not available

2011 - Response [Articolo su rivista]
Biffi, Mauro; Martignani, Cristian; Boriani, Giuseppe
abstract

N/A

2011 - Role of atrial fibrillation after transcatheter closure of patent foramen ovale in patients with or without cryptogenic stroke [Articolo su rivista]
Bronzetti, G; D'Angelo, C; Donti, A; Salomone, L; Giardini, A; Picchio, Fm; Boriani, Giuseppe
abstract

Background: Atrial fibrillation (AF) after transcatheter closure of patent foramen ovale (PFO) is not a rare complication. However little is known about the effect of atrial septal device implantation on the occurrence of this arrhythmia. Objective: The aim of this study was to evaluate the occurrence of AF in two groups of patients who underwent transcatheter PFO closure: those with a previous cryptogenic stroke and those with other index events respectively. Materials and methods: Patient population included 276 patients with documented PFO who underwent percutaneous closure at our institution. Patients were grouped on the basis of two distinct clinical presentations: a) 246 patients with history of previous cryptogenic cerebrovascular ischemic event (CIE) or b) 30 patients with other different index events. AF after PFO closure was detected by 12-lead electrocardiography or by 24-h-Holter monitoring. Results: During a mean follow-up of 17 months, new-onset AF was documented in 10 patients (4%), all included in the group with a previous cryptogenic CIE, at a mean of 1.6 months post-procedure. Comparing patients with and without AF, age (mean 56 years vs 46 years, p = 0.012) and left atrial size (4.4 cm vs 3.7 cm, p = 0.001) resulted to differ significantly. The type and size of occluder devices do not seem to impact the occurrence of AF after PFO closure. Conclusion: In patients presenting with cryptogenic stroke, especially in those with slightly enlarged left atria and age above 50-55 years, detection of a PFO should prompt an extended monitoring for excluding AF

2011 - Spotlight Issue "Electrophysiology and cardiac device therapy: why and how to approach health economics?" Volume 13 Supplement 2 May 2011 of EP Europace [Curatela]
Boriani, Giuseppe
abstract

This is a special issue of EP-Europace, with G Boriani as Guest Editor. It is the result of an initiative of the Committee on Health Economics and Outcome Research of EHRA, chaired by G Boriani. EHRA is the acronym of European Heart Rhythm Association, a branch of the European Society of Cardiology and it is the leader association on Electrophysiology and Arrhthmia science in Europe. This issue covers a wide spectrum of topics, starting from an overview of economic evaluations, and then focusing on the disease burden and emerging costs of atrial fibrillation and heart failure, two growing epidemics in western countries. The emerging role of European registries, a cornerstone of outcome research and policy making is also highlighted, as well as the important contribution of patient associations in promoting and supporting the access to evidence-based therapies. The applications of economic evaluations to a series of treatments that carry a high up-front cost, such as cardioverter defibrillators, devices for CRT, and atrial fibrillation ablation procedures are discussed in articles co-authored by both electrophysiologists and health economists. Remote monitoring, a new option for improving both patient care and the organization of device clinics, is also discussed. Finally, the application of health economics in policy making, the need for an appropriate approach to treatment with medical devices, taking into consideration the differences with pharmacological treatments, and the possibility to base decision making on a multidisciplinary approach, such as health technology assessment, are debated. In this complex scenario, the heterogeneity of reimbursement practices and the need for a refinement of DRG (diagnosis-related groups) systems and for new strategies to sustain and enhance those effective technological innovations that may be beneficial for specific patient populations are also highlighted. The issue includes 13 articles in 65 pages.

2011 - Targeting the arrhythmogenic substrate in atrial fibrillation: focus on structural remodeling [Articolo su rivista]
Raschi, E.; Boriani, Giuseppe; De Ponti, F.
abstract

Atrial fibrillation (AF) is an emerging clinical problem with multifaceted issues: current and expected prevalence, significant morbidity, potentially fatal outcome (e.g., stroke) and gaps in therapeutic approaches. Current antiarrhythmic strategies not only fail to guarantee effective rhythm control, but also cause “on target” (i.e., pro-arrhythmia, namely torsade de pointes) and “off target” (i.e., extra-cardiac toxicities) side effects. Although a number of drugs have just come out of the pipeline with promising results (e.g., dronedarone), the question arises whether channel-targeted drugs represent the only viable approach. A body of evidence has emerged supporting structural remodeling as the main arrhythmogenic substrate perpetuating AF. Fibrosis, inflammation and oxidative stress appear strongly interconnected in the pathogenesis of remodeling-induced abnormalities. Moreover, insights into extracellular matrix network strongly suggested an active cross-talk within the cardiac microenvironment, which should be further investigated as promising “anti-remodeling” approach. Therefore, pharmacological modulation of non-ionic targets (the so called “upstream” therapy) has gained interest as a preventive strategy in AF. At the present state of knowledge, renin-angiotensinaldosterone system blockers and statins offer evidence for potential clinical exploitation, while several remodeling targeted therapies have been tested only experimentally or failed when studied for human validation. Fascinating and innovative strategies have been proposed (e.g., miRNAs modulation), but the actual benefit is debated. This review will provide mechanistic insights into structural remodeling and highlight emerging upstream strategies in AF management.

2011 - The challenge of preventing stroke in elderly patients with atrial fibrillation. [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Diemberger, I; Ziacchi, M; Martignani, C.
abstract

not available

2011 - Treatment of atrial fibrillation with a dual defibrillator in heart failure patients (TRADE HF): protocol for a randomized clinical trial. [Articolo su rivista]
Botto, Gl; Boriani, Giuseppe; Favale, S; Landolina, M; Molon, G; Tondo, C; Biffi, M; Grandinetti, G; De Filippo, P; Raciti, G; Padeletti, L.
abstract

Background: Heart failure(HF) and atrial fibrillation(AF) frequently coexist in the same patient and are associated with increased mortality and frequent hospitalizations. As the concomitance of AF and HF is often associated with a poor prognosis, the prompt treatment of AF in HF patients may significantly improve outcome.Methods/design: Recent implantable cardiac resynchronization (CRT) devices allow electrical therapies to treat AF automatically. TRADE-HF (trial registration: NCT00345592; http://www.clinicaltrials.gov) is a prospective, randomized, double arm study aimed at demonstrating the efficacy of an automatic, device-based therapy for treatment of atrial tachycardia and fibrillation(AT/AF) in patients indicated for CRT. The study compares automatic electrical therapy to a traditional more usual treatment of AT/AF: the goal is to demonstrate a reduction in a combined endpoint of unplanned hospitalizations for cardiac reasons, death from cardiovascular causes or permanent AF when using automatic atrial therapy as compared to the traditional approach involving hospitalization for symptoms and in-hospital treatment of AT/AF.Discussion: CRT pacemaker with the additional ability to convert AF as well as ventricular arrhythmias may play a simultaneous role in rhythm control and HF treatment. The value of the systematic implantation of CRT ICDs with the capacity to deliver atrial therapy in HF patients at risk of AF has not yet been explored. The TRADE-HF study will assess in CRT patients whether a strategy based on automatic management of atrial arrhythmias might be a valuable option to reduce the number of hospital admission and to reduce the progression the arrhythmia to a permanent form

2011 - Which resolution for reliable ECG P-wave analysis in atrial fibrillation? [Relazione in Atti di Convegno]
Censi, Federica; Calcagnini, Giovanni; Triventi, Michele; Mattei, Eugenio; Bartolini, Pietro; Corazza, Ivan; Boriani, Giuseppe
abstract

P-wave analysis is becoming more and more used to help indentifying patients at risk for AF. Particularly, precise measurement of P-wave duration is an important factor in determining the risk of atrial arrhythmias. However, the methods to extract P-wave duration must be precise and reliable. Automatic analysis of P-wave must take into account technical aspects, one of those being the bit resolution. The aim of this manuscript is to investigate the effects of amplitude resolution of ECG acquisition systems on P-wave analysis. Starting from ECG recorded by an acquisition system with a LSB of 31 nV (24-bit on an input range of 524mVpp), we reproduced ECG signal as acquired by systems with lower resolution (16, 15, 14, 13 and 12 bit). We found that, when LSB is of the order of 128 μV (12 bit), a single P-wave is not recognizable on ECG (figure 1, upper panel). However, when averaging is applied, a P-wave template can be extracted, apparently suitable for P-wave analysis. Results obtained in terms of P-wave duration revealed that at lowest resolution (from 12 to 14 bit) the error on P-wave duration estimation is important and could lead to misleading results. However, the resolution used nowadays in modern electrocardiographs (15 and 16 bit) lead to results rather similar to those obtained with higher resolution.

2010 - 'Pill-in-the-pocket' treatment for recent-onset atrial fibrillation [4] [Articolo su rivista]
Alboni, Paolo; Botto, Giovanni L.; Boriani, Giuseppe; Russo, Giovanni; Pacchioni, Federico; Iori, Matteo; Pasanisi, Giovanni; Mancini, Marina; Maricanti, Barbara; Cappucci, Alessandro
abstract

N/A

2010 - A randomized double-blind comparison of biventricular versus left ventricular stimulation for cardiac resynchronization therapy: the Biventricular versus Left Univentricular Pacing with ICD Back-up in Heart Failure Patients (B-LEFT HF) trial. [Articolo su rivista]
Boriani, Giuseppe; Kranig, W; Donal, E; Calo, L; Casella, M; Delarche, N; Lozano, If; Ansalone, G; Biffi, M; Boulogne, E; Leclercq, C.
abstract

Biventricular (BiV) stimulation is the preferred means of delivering cardiac resynchronization therapy (CRT), although left ventricular (LV)-only stimulation might be as safe and effective. B-LEFT HF is a prospective, multicenter, randomized, double-blind study aimed to examine whether LV-only is noninferior to BiV pacing regarding clinical and echocardiographic responses.

2010 - Actual pacemaker longevity: The benefit of stimulation by automatic capture verification [Articolo su rivista]
Biffi, M; Bertini, M; Saporito, D; Ziacchi, M; Martignani, C; Diemberger, I; Boriani, Giuseppe
abstract

We evaluated the impact of an algorithm for automatic right ventricular (RV) stimulation compared to fixed-output pacing (FOP) stimulation on actual pacemaker longevity over a 9-year follow-up.

2010 - Anticancer drugs and cardiotoxicity: Insights and perspectives in the era of targeted therapy. [Articolo su rivista]
Raschi, E; Vasina, V; Ursino, Mg; Boriani, Giuseppe; Martoni, A; De Ponti, F.
abstract

Drug-induced cardiotoxicity is emerging as an important issue among cancer survivors. For several decades, this topic was almost exclusively associated with anthracyclines, for which cumulative dose-related cardiac damage was the limiting step in their use. Although a number of efforts have been directed towards prediction of risk, so far no consensus exists on the strategies to prevent and monitor chemotherapy-related cardiotoxicity. Recently, a new dimension of the problem has emerged when drugs targeting the activity of certain tyrosine kinases or tumor receptors were recognized to carry an unwanted effect on the cardiovascular system. Moreover, the higher than expected incidence of cardiac dysfunction occurring in patients treated with a combination of old and new chemotherapeutics (e.g. anthracyclines and trastuzumab) prompted clinicians and researchers to find an effective approach to the problem. From the pharmacological standpoint, putative molecular mechanisms involved in chemotherapy-induced cardiotoxicity will be reviewed. From the clinical standpoint, current strategies to reduce cardiotoxicity will be critically addressed. In this perspective, the precise identification of the antitarget (i.e. the unwanted target causing heart damage) and the development of guidelines to monitor patients undergoing treatment with cardiotoxic agents appear to constitute the basis for the management of drug-induced cardiotoxicity.

2010 - Atrial fibrillation: Adverse effects of "pill-in-the-pocket" treatment and propafenone-carvedilol interaction. [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Diemberger, I; Domenichini, G; Marziali, A; Martignani, C.
abstract

Propafenone and carvedilol share a common hepatic metabolism involving the oxidative pathway (CYP2D6). Therefore, oral loading with propafenone (as "pill-in-the-pocket" treatment of recent-onset atrial fibrillation) in a patient on concurrent carvedilol treatment may lead to a pharmacokinetic interaction, with high plasma levels of propafenone and potential drug-related adverse effects. In clinical practice, in order to improve the safety of "pill-in-the-pocket" treatment, use of propafenone loading should, in our view, be discouraged in patients on concurrent treatment with carvedilol.

2010 - Balancing the risk of hemorrhage vs thromboembolism in patients with atrial fibrillation: how to navigate between Scylla and Charybdis? [Articolo su rivista]
Boriani, Giuseppe; Diemberger, I; Biffi, M; Martignani, C.
abstract

N/A

2010 - Cardiac resynchronization therapy: is systole all that matters? [Articolo su rivista]
Biffi, M; Bertini, M; Boriani, Giuseppe
abstract

N/A

2010 - Delayed asymptomatic migration of an implantable cardioverter-defibrillator lead to the costophrenic angle. [Articolo su rivista]
Diemberger, I; Biffi, M; Martignani, C; Boriani, Giuseppe
abstract

N/A

2010 - Device therapy: A subcutaneous ICD-preliminary results. [Articolo su rivista]
Spirito, P; Boriani, Giuseppe
abstract

N/A

2010 - Effect of cardiac resynchronization therapy on subendo- and subepicardial left ventricular twist mechanics and relation to favorable outcome. [Articolo su rivista]
Bertini, M; Delgado, V; Nucifora, G; Marsan, Na; Ng, Ac; Shanks, M; Van Bommel, Rj; Borleffs, Cj; Ewe, Sh; Boriani, Giuseppe; Biffi, M; Schalij, Mj; Bax, J. J.
abstract

N/A

2010 - Exercise intolerance in chronic heart failure: mechanisms and therapies. Part I. [Articolo su rivista]
Piepoli, Mf; Guazzi, M; Boriani, Giuseppe; Cicoira, M; Corrà, U; Dalla Libera, L; Emdin, M; Mele, D; Passino, C; Vescovo, G; Vigorito, C; Villani, Gq; Agostoni, P.
abstract

N/A

2010 - Exercise intolerance in chronic heart failure: mechanisms and therapies. Part II. [Articolo su rivista]
Piepoli, Mf; Guazzi, M; Boriani, Giuseppe; Cicoira, M; Corrà, U; Dalla Libera, L; Emdin, M; Mele, D; Passino, C; Vescovo, G; Vigorito, C; Villani, G; Agostoni, P.
abstract

N/A

2010 - Health economics and outcomes research: a new challenge and field of action for the European Heart Rhythm Association. [Articolo su rivista]
Boriani, Giuseppe; Maniadakis, N; Auricchio, A; Vardas, P.
abstract

N/A

2010 - Implantable electrical devices for prevention of sudden cardiac death: data on implant rates from a 'real world' regional registry. [Articolo su rivista]
Boriani, Giuseppe; Berti, E; Biffi, M; Marino, M; Sassone, B; Villani, Gq; Bottoni, N; Malavasi, Vl; Melandri, F; Barbato, G; Talamonti, E; Marconi, M.
abstract

International and national consensus guidelines define appropriate indications for implantable cardioverter-defibrillators (ICDs), but the variability in implant rates in 'real world' clinical practice is still unknown.

2010 - Incompatibility between intravenous amiodarone and heparin in an infant [Articolo su rivista]
Bronzetti, G; D'Angelo, C; Mariucci, E; Picchio, Fm; Boriani, Giuseppe
abstract

Amiodarone is an effective antiarrhythmic agent and represents the drug of choice in the treatment of severe arrhythmias, especially in the setting of ventricular dysfunction. Amiodarone has the potential for interaction with many cardiac and non-cardiac drugs. Nonetheless few incompatibilities have been reported. We report the incompatibility between amiodarone and heparin administrated in the same vein in a case of a one month old baby with atrial flutter. This topic needs more attention, due to the frequent co-administration of these two drugs in tachyarrhythmias with high thromboembolic risk.

2010 - Interventricular delay optimization: a comparison among three different echocardiographic methods. [Articolo su rivista]
Bertini, M.; Valzania, C.; Biffi, M.; Martignani, C.; Ziacchi, M.; Pedri, S.; Domenichini, G.; Diemberger, I.; Saporito, D.; Rocchi, G.; Rapezzi, C.; Branzi, A.; Boriani, Giuseppe
abstract

To compare three different methods for obtaining interventricular-(VV) interval optimization.

2010 - Intravenous administration of flecainide or propafenone in patients with recent-onset atrial fibrillation does not predict adverse effects during 'pill-in-the-pocket' treatment. [Articolo su rivista]
Alboni, P; Botto, Gl; Boriani, Giuseppe; Russo, G; Pacchioni, F; Iori, M; Pasanisi, G; Mancini, M; Mariconti, B; Capucci, A.
abstract

Pill-in-the-pocket treatment should be prescribed only if the administration of a loading oral dose of flecainide or propafenone has been proved safe in hospital, since major adverse effects have been reported in 5% of patients during in-hospital treatment. However, in emergency rooms, the oral administration of these drugs for the conversion of atrial fibrillation (AF) is very rarely used because it is time consuming. Objective To investigate whether tolerance to intravenous administration of flecainide or propafenone might predict the safety of pill-in-the-pocket treatment-the out-of-hospital self-administration of these drugs after the onset of palpitations-in patients with AF of recent onset.

2010 - L'ottimizzazione degli intervalli AV e VV nei pazienti con device biventricolare: revisione della letteratura e contributo sperimentale [Articolo su rivista]
M., Ziacchi; M., Bertini; M., Biffi; C., Martignani; I., Diemberger; E., Cervi; C., Valzania; A., Mazzotti; B., Gardini; G., Massaro; C., Moschini; V., Mantovani; A., Marziali; Boriani, Giuseppe
abstract

La terapia di resincronizzazione è una valida opzione nel trattamento dello scompenso cardiaco. Esiste ancora però una percentuale elevata di pazienti che non risponde in termini di rimodellamento ventricolare inverso. Con lo scopo di ridurre il numero di non responder, migliorando la sincronia di contrazione atrio-ventricolare e inter/intraventricolare, negli ultimi anni ha preso piede l’ottimizzazione della programmazione degli intervalli atrio-ventricolare e interventricolare. Facendo una revisione della letteratura si può notare che i contributi sperimentali sull’ottimizzazione dei parametri AV e VV sono diversi, utilizzano svariate tecniche di ottimizzazione e i trial multicentrici condotti fino a oggi portano a conclusioni controverse soprattutto per quel che riguarda l’intervallo VV. Nella seconda parte del lavoro abbiamo confrontato tre metodiche ecocardiografiche per la valutazione dell’intervallo VV ottimale (VTI, Strain circonferenziale e velocità). In primis, abbiamo dimostrato che l’ottimizzazione dell’intervallo VV ha determinato un maggior beneficio dopo impianto di CRT, rispetto alla programmazione standard in termini di rimodellamento ventricolare inverso. Inoltre, c’è una buona correlazione tra le tre metodiche utilizzate per ottimizzare l’intervallo VV; metodiche che non solo valutano la funzione sistolica del ventricolo sinistro ma anche la dissincronia.

2010 - La tachicardiomiopatia: una revisione della letteratura [Articolo su rivista]
M., Ongari; Boriani, Giuseppe
abstract

A fast heart rate or an irregular ventricular rhythm can produce various degrees of functional impairment and structural remodeling of the ventricle referred to as tachycardia-related cardiomyopathy or tachycardiomyopathy. This form of myocardial dysfunction can be caused by supraventricular or ventricular tachyarrhythmias that are incessant and associated with ventricular rates higher than 120 bpm. It can be reversed with pharmacological or nonpharmacological rate control or arrhythmia reversion. The prevalence of ventricular and supraventricular tachyarrhythmias is high among patients with heart failure. Consequently, in clinical settings, it may be difficult to determine whether a patient with severe ventricular dysfunction and supraventricular tachyarrhythmia associated with a rapid ventricular response is suffering from tachycardiomyopathy or from heart failure complicated by the subsequent development of a supraventricular tachyarrhythmia (e.g. atrial fibrillation). This typical "chicken-or-the-egg" dilemma can be resolved by treating the arrhythmia (pharmacological or nonpharmacological rate and/or rhythm control) and closely monitoring the evolution of the left ventricular dysfunction. Proper management of tachycardiomyopathy requires appropriate decision making, use of both pharmacological and nonpharmacological treatment approaches, and close follow-up. The purpose of this review article is to examine currently available data (experimental and clinical) on this complex clinical entity and on rate-control therapy

2010 - Long-term follow-up of patients with syncope evaluated by head-up tilt test. [Articolo su rivista]
Domenichini, G; Diemberger, I; Biffi, M; Martignani, C; Valzania, C; Bertini, M; Saporito, D; Ziacchi, M; Branzi, A; Boriani, Giuseppe
abstract

Clinicians may be tempted to consider a positive head-up tilt test (HUTT) an unfavorable prognostic indicator. We investigated whether results of routine HUTT predict long-term recurrence of syncope.

2010 - Management of patients receiving implantable cardiac defibrillator shocks: recommendations for acute and long-term patient management. [Articolo su rivista]
Braunschweig, F; Boriani, Giuseppe; Bauer, A; Hatala, R; Herrmann Lingen, C; Kautzner, J; Pedersen, Ss; Pehrson, S; Ricci, R; Schalij, M. J.
abstract

N/A

2010 - P-wave characteristics after electrical external cardioversion: Predictive indexes of relapse [Relazione in Atti di Convegno]
Censi, Federica; Calcagnini, Giovanni; Triventi, Michele; Mattei, Eugenio; Bartolini, Pietro; Corazza, Ivan; Boriani, Giuseppe
abstract

Atrial fibrillation (AF) is the most common arrhythmia in the western countries and accounts for hundred thousand strokes per year. Electrocardiographic characteristics of AF have been demonstrated to help identify patients at risk of developing AF. Prolonged and highly fragmented P-waves have been observed in patients prone to AF, and time-domain. Morphological characteristics of the P-wave from surface ECG recordings turned out to significantly distinguish patients at risk of AF. The aim of this study is to evaluate the morphological and time-domain characteristics of the P-wave in patients with AF relapse after cardioversion, respect to patients without. 14 patients who underwent successful electrical cardioversion for persistent AF were enrolled. Five minute ECG recordings were performed for each subject, immediately post-successful cardioversion. ECG signals were acquired by using a 16-lead mapping system for high-resolution biopotential measurements (sample frequency 2 kHz, 31 nV resolution, 0-400 Hz bandwidth). From the 16 recordings, a standard 12-lead ECG was derived and analyzed in terms of signal-averaged P-wave. Time-domain and mor-phological characteristics were estimated from the averaged P-waves of each lead. Time-domain features were quantified as: maximum P-wave duration in any of the 12 leads (Pmax), minimum Pwave duration in any of the leads (Pmin), P-wave dispersion (Pdisp=Pmax-Pmin), and Pindex (standard devia-tion of Pwave duration in any of the 12 leads). Morphological characteristics were extracted from a Gaussian function-based model of the P-wave as: average model order (Nav), maximum number of zero-crossing (PCmax), and maximum and average number of maxima and minima (FCImax and FCIav) in any of the leads. The results obtained so far indicate that the morphological and time-domain characteristics distinguish between patients with AF relapse and patients without. © 2010 IEEE.

2010 - Prediction of atrial fibrillation in patients with an implantable cardioverter-defibrillator and heart failure. [Articolo su rivista]
Bertini, M; Borleffs, Cj; Delgado, V; Ng, Ac; Piers, Sr; Shanks, M; Antoni, Ml; Biffi, M; Boriani, Giuseppe; Schalij, Mj; Bax, Jj; Van de Veire, N. R.
abstract

N/A

2010 - Prediction of cardiac resynchronization therapy response: value of calibrated integrated backscatter imaging. [Articolo su rivista]
Bertini, M; Delgado, V; den Uijl, Dw; Nucifora, G; Ng, Ac; van Bommel, Rj; Borleffs, Cj; Boriani, Giuseppe; Schalij, Mj; Bax, Jj
abstract

Left ventricular (LV) fibrosis is important for the response to cardiac resynchronization therapy (CRT). Calibrated integrated backscatter derived by 2D echocardiography quantifies myocardial ultrasound reflectivity, which may provide a surrogate of LV fibrosis. The aim of the study was first, to investigate the relation of myocardial ultrasound reflectivity assessed with calibrated integrated backscatter on CRT response, and second, to explore the "myocardial ultrasound reflectivity-CRT response" relation in patients with ischemic and nonischemic heart failure (HF).

2010 - Prophylactic implantable defibrillator in patients with arrhythmogenic right ventricular cardiomyopathy/dysplasia and no prior ventricular fibrillation or sustained ventricular tachycardia [Articolo su rivista]
Corrado, D; Calkins, H; Link, Ms; Leoni, L; Favale, S; Bevilacqua, M; Basso, C; Ward, D; Boriani, Giuseppe; Ricci, R; Piccini, Jp; Dalal, D; Santini, M; Buja, G; Iliceto, S; Estes NA, 3rd; Wichter, T; Mckenna, Wj; Thiene, G; Marcus, F. I.
abstract

BACKGROUND: The role of implantable cardioverter-defibrillator (ICD) in patients with arrhythmogenic right ventricular cardiomyopathy/dysplasia and no prior ventricular fibrillation (VF) or sustained ventricular tachycardia is an unsolved issue. METHODS AND RESULTS: We studied 106 consecutive patients (62 men and 44 women; age, 35.6±18 years) with arrhythmogenic right ventricular cardiomyopathy/dysplasia who received an ICD based on 1 or more arrhythmic risk factors such as syncope, nonsustained ventricular tachycardia, familial sudden death, and inducibility at programmed ventricular stimulation. During follow-up of 58±35 months, 25 patients (24%) had appropriate ICD interventions and 17 (16%) had shocks for life-threatening VF or ventricular flutter. At 48 months, the actual survival rate was 100% compared with the VF/ventricular flutter-free survival rate of 77% (log-rank P=0.01). Syncope significantly predicted any appropriate ICD interventions (hazard ratio, 2.94; 95% confidence interval, 1.83 to 4.67; P=0.013) and shocks for VF/ventricular flutter (hazard ratio, 3.16; 95% confidence interval, 1.39 to 5.63; P=0.005). The positive predictive value of programmed ventricular stimulation was 35% for any appropriate ICD intervention and 20% for shocks for VF/ventricular flutter, with a negative predictive value of 70% and 74%. None of the 27 asymptomatic patients with isolated familial sudden death had appropriate ICD therapy. Twenty patients (19%) had inappropriate ICD interventions, and 18 (17%) had device-related complications. CONCLUSIONS: One fourth of patients with arrhythmogenic right ventricular cardiomyopathy/dysplasia and no prior sustained ventricular tachycardia or VF had appropriate ICD interventions. Syncope was an important predictor of life-saving ICD intervention and is an indication for ICD. Prophylactic ICD may not be indicated in asymptomatic patients because of their low arrhythmic risk regardless of familial sudden death and programmed ventricular stimulation findings. Programmed ventricular stimulation had a low predictive accuracy for ICD therapy.

2010 - Radionuclide angiographic determination of regional left ventricular systolic function during rest and exercise in patients with nonischemic cardiomyopathy treated with cardiac resynchronization therapy. [Articolo su rivista]
Valzania, C; Fallani, F; Gavaruzzi, G; Biffi, M; Martignani, C; Diemberger, I; Bertini, M; Domenichini, G; Ziacchi, M; Gadler, F; Eriksson, Mj; Braunschweig, F; Franchi, R; Branzi, A; Rapezzi, C; Boriani, Giuseppe
abstract

N/A

2010 - Role of drugs and devices in patients at risk of sudden cardiac death. [Articolo su rivista]
Boriani, Giuseppe; Diemberger, I; Valzania, C; Biffi, M; Martignani, C; Raschi, E; Mantovani, V; Ziacchi, M; Bertini, M; De Ponti, F; Branzi, A.
abstract

N/A

2010 - The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) study: rationale and design. [Articolo su rivista]
Burri, H; Quesada, A; Ricci, Rp; Boriani, Giuseppe; Davinelli, M; Favale, S; Da Costa, A; Kautzner, J; Moser, R; Navarro, X; Santini, M.
abstract

With the advent of remote monitoring, current models of implantable cardioverter defibrillators (ICDs) have the possibility of sending automatic alert messages that allow early diagnosis of events such as lung fluid overload, atrial fibrillation and device integrity issues. Timely treatment of these events has the potential to improve patient outcome, but this has not as yet been proven.

2010 - Trial-generated profiles for implantation of electrical devices in outpatients with heart failure: real-world prevalence and 1-year outcome. [Articolo su rivista]
Boriani, Giuseppe; Rapezzi, C; Diemberger, I; Gonzini, L; Gorini, M; cci D, L. u.; Sinagra, G; Cooke, Rm; Di Pasquale, G; Tavazzi, L; Maggioni, Ap
abstract

Randomized controlled trials have generated strong evidence on the efficacy of electrical device therapy in selected patients with heart failure (HF). The enrolment criteria of these three trials generated patient profiles that helped to shape current guidelines on chronic heart failure (CHF) treatment and sudden cardiac death (SCD) prevention. We investigated the prevalence of trial-generated profiles for implantable defibrillator or cardiac resynchronization therapy candidacy among HF outpatients; we explored differences between real-world and trial populations and we evaluated 1-year survival without device treatment.

2009 - A changing scenario in the clinical use of implantable defibrillators: the need for long-term data on lead performance. [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Marziali, A; Diemberger, I; Martignani, C.
abstract

N/A

2009 - A prospective randomized evaluation of VV delay optimization in CRT-D recipients: Echocardiographic observations from the RHYTHM II ICD study [Articolo su rivista]
Boriani, Giuseppe; Biffi, Mauro; Müller, Cord Paul; Seidl, Karl Heinz; Grove, Rainer; Vogt, Jürgen; Danschel, Wilfried; Schuchert, Andreas; Deharo, Jean Claude; Becker, Thorsten; Boulogne, Eric; Trappe, Hans Joachim
abstract

Background: All current cardiac resynchronization therapy (CRT) devices allow the programming of the atrioventricular (AV/PV) delays and the sequential stimulation of the ventricles via the inter ventricular (VV) delay. Aim: This post hoc analysis of the RHYTHM II study was conducted to compare the reverse remodeling associated with VV delay optimization in patients randomly assigned to simultaneous (SIM) biventricular stimulation versus patients assigned to optimized VV delay programming (OPT) (1:3 randomization scheme). Methods: The analysis included 14 patients assigned to the SIM group and 34 patients to the OPT group who completed the 6-month follow-up period with paired echocardiographic recordings. Results: In both study groups, changes consistent with left ventricular (LV) remodeling were observed between baseline and 6 months, with significant improvements in LV function and decrease in LV dimensions. In the OPT group, there was also a decrease in left atrial diameter and mitral valve closure to opening time. At 6 months, the overall proportion of echocardiographic responders (≥10% decrease in LV end-systolic volume or ≥5% absolute increase in LV ejection fraction) was similar in both groups. The optimal AV/VV delays, evaluated by maximization of LV outflow tract velocity time integral, changed over time. Conclusions: Ventriculo-ventricular delay optimization was associated with better immediate hemodynamic function than simultaneous biventricular stimulation, though did not promote additional reverse remodeling at 6 months and did not increase the proportion of echocardiographic responders to CRT. Optimization of both the AV and VV intervals was patient-specific and optimal values changed over time. © 2009, The Authors.

2009 - A simplified biventricular defibrillator with fixed long detection intervals reduces implantable cardioverter defibrillator (ICD) interventions and heart failure hospitalizations in patients with non-ischaemic cardiomyopathy implanted for primary prevention: the RELEVANT [Role of long dEtection window programming in patients with LEft VentriculAr dysfunction, Non-ischemic eTiology in primary prevention treated with a biventricular ICD] study. [Articolo su rivista]
Gasparini, M; Menozzi, C; Proclemer, A; Landolina, M; Iacopino, S; Carboni, A; Lombardo, E; Regoli, F; Biffi, M; Burrone, V; Denaro, A; Boriani, Giuseppe
abstract

To investigate the efficacy and safety of a cardiac resynchronization therapy with cardioverter-defibrillator (CRT-D) device with simplified ventricular tachycardia management in patients with non-ischaemic heart failure (HF) and primary prevention implantable cardioverter defibrillator (ICD) indication.

2009 - Analisi costi-benefici dell’impianto di cardioverter-defibrillatore [Capitolo/Saggio]
Boriani, Giuseppe; M., Biffi; C., Martignani; E., Cervi; I., Diemberger; A., Branzi
abstract

Revisione e trattazione della complessa problematica della valutazione economica dei cardioverter-defibrillatori, dotati di provata efficacia clinica, ma con un alto costo iniziale del dispositivo.

2009 - Atrial fibrillation therapy in patients with a CRT defibrillator with wireless telemetry [Articolo su rivista]
Crossley, Gh; Aonuma, K; Haffajee, C; Shoda, M; Meijer, A; Bauer, A; Boriani, Giuseppe; Svendsen, J; Thomas, S; Wiggenhorn, C; Unterberg Buchwald, C.
abstract

BACKGROUND: Atrial fibrillation (AF) is a major cause of morbidity and mortality, especially in patients with congestive heart failure. OBJECTIVES: The purposes of this international, prospective multicenter study were to evaluate the efficacy of atrial shock therapy in patients with a cardiac resynchronization therapy defibrillator (CRT-D) and to evaluate the safety of the new CRT-D. The effectiveness of a new wireless telemetry system was also evaluated. METHODS: A total of 282 patients, without permanent AF, who had indications for a CRT-D were included. Atrial shock therapy was tested on both spontaneous and induced AF episodes. The effectiveness of the Medtronic wireless telemetry system (Conexus; Medtronic Inc., Minneapolis, MN, USA) was also tested. Secondary endpoints included the heart failure Clinical Composite Response, system performance evaluation, and adverse event summary. RESULTS: Atrial shock therapy was successful in 168 of 171 episodes (98.2%). Of these, 138 episodes were induced and 33 were spontaneous. Successful cardioversion occurred in 137 of the 138 induced-AF episodes (86.1% with 12 joule (J), 13.1% with 24 J, and 0.7% with 35 J). During the first 3 months of implant, there were 43 system-related complications in 37 subjects out of 278 subjects. There were 1,999 Conexus telemetry uses recorded during this study. This includes 282 uses during the implant procedure. There were no cases of complete loss of telemetry or any adverse events reported using this system. CONCLUSION: We achieved an atrial shock efficacy of 98.2% in patients who met standard CRT-D indications. The wireless telemetry performed well with no reported unanticipated adverse device effects

2009 - Automatic management of left ventricular stimulation: hints for technologic improvement. [Articolo su rivista]
Biffi, M; Bertini, M; Saporito, D; Ziacchi, M; Stabellini, S; Valsecchi, S; Ricci, V; Boriani, Giuseppe
abstract

We used a cardiac resynchronization therapy defibrillator device with an algorithm for automatic verification of left ventricular (LV) stimulation to understand LV threshold variability, such as to provide hints to program the algorithm features. We also evaluated the algorithm performance over long term, and tested a stimulation setting to achieve 99% effective stimulation while maximizing device longevity.

2009 - Clinical and arrhythmic outcomes after implantation of a defibrillator for primary prevention of sudden death in patients with post-myocardial infarction cardiomyopathy: The Survey to Evaluate Arrhythmia Rate in High-risk MI patients (SEARCH-MI) [Articolo su rivista]
Santini, M; Russo, M; Botto, G; Lunati, M; Proclemer, A; Schmidt, B; Erdogan, A; Helmling, E; Rauhe, W; Desaga, M; Santi, E; Messier, M; Boriani, Giuseppe
abstract

To evaluate clinical and arrhythmic outcomes in post-infarction cardiomyopathy patients implanted with a defibrillator (ICD) for primary prevention of sudden death.

2009 - Clinical implications of left superior vena cava persistence in candidates for pacemaker or cardioverter-defibrillator implantation [Articolo su rivista]
Biffi, M; Bertini, M; Ziacchi, M; Martignani, C; Valzania, C; Diemberger, I; Branzi, A; Boriani, Giuseppe
abstract

Persistence of a left superior vena cava (LSVC) has been reported in 0.3%-0.4% of candidates for pacemaker (PM) or cardioverter-defibrillator (ICD) implantation. The aim of the study was to evaluate the clinical implications of LSVC persistence for proper device performance. We observed the prevalence of LSVC during a 15-year period. A total of 2077 consecutive patients underwent PM implantation over a 15-year period: 7 had persistent LSVCs (0.34%). Among 599 patients undergoing ICD implantation, 4 LSVCs (0.66%) were observed. Overall LSVC persistence was found in 11/2676 (0.41%) patients. The right superior vena cava was absent in 4/11 (36%) patients. The leads were placed from the left subclavian approach in 5/7 PM patients: 2 received an elective right sided approach due to physician preference. All ICD patients had the device placed left pectoral with a single-coil lead: defibrillation therapy was effective in the long term in all but one patient, who required the addition of a subcutaneous array. Left superior vena cava persistence in PM/ICD patients is similar to the general population (0.41% in our study). The left-sided implant may be skill-demanding during lead placement; however, this task can be accomplished in the majority of cases, with a reliable outcome in the short term and appropriate device performance at follow-up.

2009 - Decrease in patient radiation exposure by a tantalum filter during electrophysiological procedures. [Articolo su rivista]
Rossi, Pl; Mariselli, M; Corazza, I; Bianchini, D; Biffi, M; Martignani, C; Zannoli, R; Boriani, Giuseppe
abstract

Minimization of X-ray exposure remains a primary issue in cardiac electrophysiology. The effectiveness of X-ray beam filtration during cardiac electrophysiological procedures was therefore studied, using a 0.05-mm-thick tantalum (Ta) foil, as a filter on the primary X-ray beam, to reduce the patient dose without degradation of image quality.

2009 - Effect of high-pass filtering on ECG signal on the analysis of patients prone to atrial fibrillation [Articolo su rivista]
Censi, F; Calcagnini, G; Triventi, M; Mattei, E; Bartolini, P; Corazza, I; Boriani, Giuseppe
abstract

The aim of this study was to assess the effect of filtering techniques on the time-domain analysis of the ECG. Multi-lead ECG recordings obtained from chronic atrial fibrillation (AF) patients after successful external cardioversion have been acquired. Several high-pass filtering techniques and three cut-off frequency values were used: Bessel and Butterworth four-pole and two-pole bidirectional and unidirectional filters, at 0.01, 0.05 and 0.5 Hz low cut-off frequency. As a reference, a beat-by-beat linear piecewise interpolation was used to remove baseline wander, on each P-wave. Results show that ECG filtering affects the estimation of P-wave duration in a manner that depends upon the type of filter used: particularly, the bidirectional filters caused negligible variation of P-wave duration, while unidirectional ones provoked an increase higher than 8%.

2009 - Effectiveness of cardiac resynchronization therapy in heart failure patients with valvular heart disease: comparison with patients affected by ischaemic heart disease or dilated cardiomyopathy. The InSync/InSync ICD Italian Registry. [Articolo su rivista]
Boriani, Giuseppe; Gasparini, M; Landolina, M; Lunati, M; Biffi, M; Santini, M; Padeletti, L; Molon, G; Botto, G; De Santo, T; Valsecchi, S.
abstract

To analyse the effectiveness of cardiac resynchronization therapy (CRT) in patients with valvular heart disease (a subset not specifically investigated in randomized controlled trials) in comparison with ischaemic heart disease or dilated cardiomyopathy patients.

2009 - Effects of Cardiac Resynchronization Therapy on Left Ventricular Twist [Articolo su rivista]
Bertini, M; Marsan, Na; Delgado, V; van Bommel, Rj; Nucifora, G; Borleffs, Cj; Boriani, Giuseppe; Biffi, M; Holman, Er; van der Wall, Ee; Schalij, Mj; Bax, J. J.
abstract

This study explored the effects of cardiac resynchronization therapy (CRT) on left ventricular (LV) twist, particularly in relation to LV lead position.

2009 - Exercise stress echocardiography is superior to rest echocardiography in predicting left ventricular reverse remodelling and functional improvement after cardiac resynchronization therapy. [Articolo su rivista]
Rocchi, G; Bertini, M; Biffi, M; Ziacchi, M; Biagini, E; Gallelli, I; Martignani, C; Cervi, E; Ferlito, M; Rapezzi, C; Branzi, A; Boriani, Giuseppe
abstract

Cardiac resynchronization therapy (CRT) improves functional capacity and survival in heart failure. However, one-third of patients fail to respond to CRT. Resting left ventricular (LV) dyssynchrony assessed by echocardiography (ECHO) showed discordant results in identifying CRT responders. LV dyssynchrony can totally change during exercise. Aim of this study was to evaluate whether exercise dyssynchrony could select responders to CRT.

2009 - Expenditure and value for money: the challenge of implantable cardioverter defibrillators [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Martignani, C; Diemberger, I; Valzania, C; Bertini, M; Branzi, A.
abstract

Many technology-driven interventions entail considerable financial cost, raising affordability issues. The implantable cardioverter defibrillator (ICD) is a case of an effective primary prevention intervention with high initial costs that is capable of delivering long-term population benefits. At first glance, such interventions may provoke diffidence, if not active resistance, due to the financial burdens which inevitably accompany their widespread adoption. In this article, we review the available economic tools that can help address the ICD cost issue. We think awareness of such knowledge may facilitate dialogues between physicians, administrators and policymakers, and help foster rational decision-making.

2009 - Impact of time to reperfusion after acute myocardial infarction on myocardial damage assessed by left ventricular longitudinal strain. [Articolo su rivista]
Bertini, M; Mollema, Sa; Delgado, V; Antoni, Ml; Ng, Ac; Holman, Er; Boriani, Giuseppe; Schalij, Mj; Bax, J. J.
abstract

The relation between cardiac troponin T (cTnT) and regional strain in patients with acute myocardial infarction (AMI) was investigated. Furthermore, the effect of symptoms-to-balloon time on impairment in regional strain after AMI was evaluated. A total of 157 consecutive patients with AMI who underwent primary percutaneous coronary intervention were included. Two-dimensional echocardiography soon after percutaneous coronary intervention was performed. Speckle-tracking analysis was applied to assess left ventricular global and regional longitudinal peak systolic strain (LPSS). Infarcted area was defined based on the culprit vessel. Mean left ventricular ejection fraction was 47 +/- 7%. Global LPSS was -14.4 +/- 3.2%. The infarcted area LPSS was significantly decreased compared with global LPSS (-11.3 +/- 4.5%, p <0.001). The major reflector of cTnT was infarcted area LPSS (beta 0.47, p <0.001). Mean symptoms-to-balloon time was 212 +/- 92 minutes. Based on this time, the study population was divided in tertiles. In the group with the shortest symptoms-to-balloon time, global LPSS and infarcted area LPSS were less impaired compared with groups with longer symptoms-to-balloon time (p <0.01 for the 2 comparisons). In conclusion, myocardial strain was related to peak levels of cTnT, thus reflecting damage after AMI. Early reperfusion resulted in decreased myocardial damage in the infarcted area as quantified with strain.

2009 - Is cardiac resynchronization therapy cost-effective? [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Martignani, C; Valzania, C; Diemberger, I; Bertini, M; Domenichini, G; Ziacchi, M; Branzi, A.
abstract

Cardiac resynchronization therapy (CRT) is a treatment of proven efficacy for selected patients with heart failure and associated conduction disturbances. The increasing financial burden that healthcare systems face has increased the interest in cost-effectiveness and cost-utility estimates, focused on devices with defibrillation capabilities (CRT-D), with a high upfront cost, as well as on simpler devices providing only biventricular pacing (CRT-P). Available economic estimates are largely dependent on data source, assumptions, modelling technique, time horizon, and perspective, leading to some variability in cost-effectiveness and cost-utility estimates. As a whole, cost-effectiveness and cost-utility estimates of both CRT-P and CRT-D improve as the time horizon examined is lengthened and appear to be below US$50,000 per quality-adjusted life-year, a threshold value commonly adopted for coverage of healthcare interventions in the USA and quite comparable with similar thresholds used within Europe. Limited data are available on the comparative cost-effectiveness or cost-utility of CRT-P and CRT-D devices. Moreover, more data on the effectiveness and long-term benefits of CRT-D and CRT-P are needed in order to estimate better the value of these treatments in the 'real world, as well as for attempts to improve cost-effectiveness through improved patient selection.

2009 - La sindrome da pacemaker. [Capitolo/Saggio]
Boriani, Giuseppe; I., Diemberger; M., Biffi; C., Martignani
abstract

Trattazione completa sulla problematche della sindrome da pacemaker, con focus su diagnosi e trattamento.

2009 - Left Ventricular Rotational Mechanics in Acute Myocardial Infarction and in Chronic (Ischemic and Nonischemic) Heart Failure Patients [Articolo su rivista]
Bertini, M; Nucifora, G; Marsan, Na; Delgado, V; van Bommel, Rj; Boriani, Giuseppe; Biffi, M; Holman, Er; Van der Wall, Ee; Schalij, Mj; Bax, J. J.
abstract

Left ventricular (LV) twist and untwisting rate are emerging as global and thorough parameters for assessment of LV function. This study explored differences of LV twist and untwisting rate in patients with acute myocardial infarction (AMI) and patients with ischemic and nonischemic chronic heart failure (HF). Fifty patients with AMI, 49 with ischemic HF, and 38 with nonischemic HF were studied. As a control group, 28 subjects without evidence of structural heart disease were included. Speckle-tracking analysis was applied to LV short-axis images at basal and apical levels. LV twist was defined as the net difference of apical and basal rotations at isochronal time points. The first time derivative of LV untwist was defined as the LV untwisting rate. Compared with control subjects, peak LV twist was decreased in patients with AMI and extremely decreased in those with HF (p <0.001, analysis of variance). A strong correlation (r = 0.87, p <0.001) was found between peak LV twist and LV ejection fraction in the overall study population. LV untwisting rate was progressively decreased in patients with AMI and HF compared with control subjects (p <0.001, analysis of variance). A moderate correlation (r = 0.56, p <0.001) was noted between peak LV untwisting rate and grade of diastolic dysfunction in the overall study population. In conclusion, LV twist and untwisting rate are strongly related to LV systolic and diastolic functions, respectively. Impairment of LV function observed in patients with AMI and HF is associated with a decrease of LV twist and untwisting rate.

2009 - Lifetime cost-effectiveness of prophylactic implantation of a cardioverter defibrillator in patients with reduced left ventricular systolic function: Results of markov modelling in a european population [Articolo su rivista]
Cowie, Mr; Marshall, D; Drummond, M; Ferko, N; Maschio, M; Ekman, M; de Roy, L; Heidbuchel, H; Verboven, Y; Braunschweig, F; Linde, C; Boriani, Giuseppe
abstract

Current European guidelines recommend prophylactic implantation of cardioverter defibrillators (ICDs) in patients with a reduced left ventricular ejection fraction (LVEF) who are not in NYHA class IV and have reasonable life expectancy. Cost and benefit implications of this recommendation have not been reported from a European perspective.

2009 - Phrenic stimulation: a challenge for cardiac resynchronization therapy [Articolo su rivista]
Biffi, M; Moschini, C; Bertini, M; Saporito, D; Ziacchi, M; Diemberger, I; Valzania, C; Domenichini, G; Cervi, E; Martignani, C; Sangiorgi, D; Branzi, A; Boriani, Giuseppe
abstract

Phrenic stimulation (PS) may hinder left ventricular (LV) pacing. We prospectively observed its prevalence in consecutive patients with cardiac resynchronization therapy (CRT) devices.

2009 - Presence and duration of atrial fibrillation detected by continuous monitoring: crucial implications for the risk of thromboembolic events. [Articolo su rivista]
Botto, Gl; Padeletti, L; Santini, M; Capucci, A; Gulizia, M; Zolezzi, F; Favale, S; Molon, G; Ricci, R; Biffi, M; Russo, G; Vimercati, M; Corbucci, G; Boriani, Giuseppe
abstract

Asymptomatic atrial fibrillation (AF) can expose patients to the risk of stroke. The primary objective of this study was to assess the incidence of thromboembolic events in relationship with CHADS(2) (congestive heart failure, hypertension, age >or=75 years, diabetes mellitus, and prior stroke, or transient ischemic attack) score and AF presence/duration. The secondary objective was to compare intermittent versus continuous monitoring strategies.

2009 - Prognostic implications of the Doppler restrictive filling pattern in hypertrophic cardiomyopathy [Articolo su rivista]
Biagini, E; Spirito, P; Rocchi, G; Ferlito, M; Rosmini, S; Lai, F; Lorenzini, M; Terzi, F; Bacchi Reggiani, L; Boriani, Giuseppe; Branzi, A; Boni, L; Rapezzi, C.
abstract

The Doppler echocardiographic pattern of restrictive left ventricular (LV) filling has proved to be an important predictor of clinical course and prognosis in dilated cardiomyopathy. However, the relation between restrictive filling pattern and clinical course has not been systematically investigated in hypertrophic cardiomyopathy (HC). We assessed the prognostic implications of the Doppler restrictive filling pattern in 239 consecutive patients with HC in whom Doppler measurements of LV filling had been systematically recorded at initial evaluation and during follow-up. Restrictive LV filling was identified in 14 patients (5.9%) at initial evaluation and developed in 22 (9.2%) during follow-up. A close relation was identified between restrictive filling pattern and end-stage HC, with patients with restrictive filling showing a sixfold increase in risk of developing end-stage HC (hazard ratio 6.25, 95% confidence interval 1.90 to 20.57, p = 0.003). Over a median follow-up of 9.7 years, 22 patients (9.2%) died suddenly or received appropriate cardioverter-defibrillator interventions, and 54 (22.6%) had HC-related death or underwent heart transplantation. In a set of univariate and multivariate analyses including each of the generally accepted risk factors for cardiac death in HC, the restrictive filling pattern was a strong and independent marker of increased risk (hazard ratio for sudden cardiac events 3.51, 95% confidence interval 1.37 to 8.95, p = 0.009; hazard ratio for HC-related death or heart transplantation 3.54, 95% confidence interval 1.91 to 6.57, p <0.001) compared to patients without restrictive filling. In conclusion, in our study cohort, the Doppler pattern of restrictive LV filling proved to be a strong predictor of sudden death and HC-related death, independently of other markers for unfavorable prognosis in this disease.

2009 - Remote Monitoring of Patients with an Implanted Device and Patients' Outcomes: The Potential for "Win-Win" Dynamics. [Articolo su rivista]
Boriani, Giuseppe; Diemberger, I; Mantovani, V; Biffi, M; Martignani, C.
abstract

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2009 - Reply to reader's comment: "Electrocardiographic optimization of cardiac resynchronization devices: simple, but not so simple!" by Mont et al [Articolo su rivista]
Bertini, M; Biffi, M; Ziacchi, M; Martignani, C; Boriani, Giuseppe
abstract

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2009 - Resolution of atrial thrombosis with heparin in a newborn with atrial flutter [Articolo su rivista]
Bronzetti, G; D'Angelo, C; Angelini, A; Picchio, Fm; Boriani, Giuseppe
abstract

Atrial thrombosis is a relatively rare event in children. We report a case of a newborn with AFI who after restoration of sinus rhythm, developed atrial thrombus on a prominent Chiari network floating between the right and left atrium through the patent foramen ovale. The thrombus was resolved following treatment with heparin without events. Conclusion: Atrial stunning was proposed as a key mechanistic phenomenon because the thrombus occurred after the cardioversion of AFI to sinus rhythm. Heparin may be effective in the resolution of atrial thrombus within a few days

2009 - Response [Pacing and Clinical Electrophysiology] [Articolo su rivista]
Boriani, Giuseppe; Biffi, Mauro
abstract

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2009 - Terapia farmacologica in acuto [Capitolo/Saggio]
Boriani, Giuseppe
abstract

Trattazione con schemi e tabelle dei presidi farmacologici per il trattamento in acuto di fibrillazione e flutter atriale, con indiicazione di dosaggi, indicazioni e controindicazioni dei farmaci antiaritmici.

2009 - The CONVERT trial [Articolo su rivista]
Boriani, Giuseppe; Marziali, A; Cappato, R.
abstract

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2009 - The QRS interval in patients treated with resynchronization therapy: which value? [Articolo su rivista]
Boriani, Giuseppe; Bertini, M; Diemberger, I; Biffi, M; Martignani, C.
abstract

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2009 - Time-domain analysis of the ecg P-Wave after external cardioversion for persistent atrial fibrillation [Relazione in Atti di Convegno]
Censi, F.; Calcagnini, G.; Triventi, M.; Mattei, E.; Bartolini, P.; Corazza, I.; Boriani, G.
abstract

Atrial fibrillation is the most common arrhythmia with an increasing prevalence related to ageing. Its societal impact is large because of the morbidity, predominantly related to stroke as a consequence of embolization from the thrombi in the atrium, but also to heart failure. Normal cardiac impulse initiation begins in the sinoatrial node and then travels through working atrial myocardium. During this time, surface ECG recordings show the P-wave. If the atrial depolarization pattern deviates from the physiological pattern, the morphology of the P-wave changes, resulting in prolonged and highly variable P-waves. Since abnormal P-waves have been observed in patients prone to AF, a more advanced analysis of P-wave characteristics based on the extraction of morphological features might contribute to a better identification of patients at risk. The aim of this study is to evaluate the morphological and time-domain characteristics of the P-wave within 6 months after successful electrical cardioversion. The study included 35 patients with preserved left ventricular function, who underwent successful electrical cardioversion for persistent AF. Five minute ECG recordings were performed for each subject, soon after normal sinus rhythm restoration by external electrical cardioversion, and after 6 months. ECG signals were acquired by using a 16-lead mapping system for high-resolution biopotential measurements (sample frequency 2 kHz, 31 nV resolution, 0-400 Hz bandwidth). Time-domain and morphological characteristics were estimated from averaged P-waves for each lead. The results obtained so far indicate that the morphological and time-domain characteristics of the P-wave do not vary within the 6-months after external successful cardioversion, but can predict AF recurrence. © 2009 Springer Berlin Heidelberg.

2009 - Troponin I rise after pacemaker implantation at the time of "universal definition of myocardial infarction" [Articolo su rivista]
Martignani, C; Diemberger, I; Biffi, M; Ziacchi, M; Saporito, D; Valzania, C; Bertini, M; Domenichini, G; Branzi, A; Boriani, Giuseppe
abstract

We assessed incidence, magnitude, and time course of cardiac troponin I (cTnI) increase after pacemaker implantation in patients without acute coronary syndromes (ACSs). Seventy patients (mean age 71 years, interquartile range 44 to 92, 38 men) undergoing elective implantation of a single-/dual-chamber pacemaker with active/passive fixation leads were enrolled, excluding subjects with clinical suspicion of ACS, abnormal basal cTnI level, or presenting conditions predisposing to abnormal cTnI. Cardiac TnI concentrations were determined in basal conditions, at the end of the procedure, and after 8, 12, and 24 hours. Single-/dual-chamber devices were implanted in 31 of 39 patients. Cardiac TnI peak concentration occurred within the 12-hour assay in 69 of 70 patients; 26 of 70 had a cTnI above the normal cut-off range. All patients presented normal cTnI at 24-hour assay. In conclusion, pacemaker implantation is associated with increases of cTnI levels in up to 37% of patients. This can affect the specificity of cTnI assessment for ruling out ACS, especially within 12 hours after the procedure. These data deserve consideration in a contemporary setting, in which troponin has gathered a pivotal role in the diagnosis and therapy of ACS, and in particular clinical presentations in which electrocardiogram loses its diagnostic capabilities (due to paced rhythms) and symptoms may be lacking or confusing.

2008 - A comparison among three different echocardiographic methods for Interventricular delay optimization. Poster European Congress of Cardiology 2008 [Articolo su rivista]
M., Bertini; C., Valzania; M., Biffi; C., Martignani; G., Domenichini; D., Saporito; M., Ziacchi; I., Diemberger; S., Pedri; Boriani, Giuseppe
abstract

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2008 - A prospective randomized evaluation of VV delay optimization in CRT patients. Proceedings 16th World Congress in Cardiac Electrophysiology and Cardiac Techniques [Articolo su rivista]
Boriani, Giuseppe; M., Biffi; K. H., Seidl; R., Grove; J., Vogt; W., Danshel; A., Schuckert; Deharo, J. C.; Muller, C. P.; T., Becker; E., Boulogne; Trappe, H. J. J.
abstract

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2008 - A randomized comparison of amiodarone and class IC antiarrhythmic drugs to treat atrial fibrillation in patients paced for sinus node disease: the Prevention Investigation and Treatment: A Group for Observation and Research on Atrial arrhythmias (PITAGORA) trial. [Articolo su rivista]
Gulizia, M; Mangiameli, S; Orazi, S; Chiarandà, G; Piccione, G; Di Giovanni, N; Colletti, A; Pensabene, O; Lisi, F; Vasquez, L; Grammatico, A; Boriani, Giuseppe
abstract

BACKGROUND: Rhythm control is an important goal in the treatment of recurrent atrial tachyarrhythmias (AT). The PITAGORA study was a randomized trial in patients paced for sinus node disease (SND), designed to test the noninferiority of class IC antiarrhythmic drugs (AADs) to amiodarone in terms of a primary end point composed of death, permanent AT, cardiovascular hospitalization, atrial cardioversion, or AAD change. METHODS: Randomization was stratified to assign 2 patients to amiodarone and 2 patients to class IC AADs: propafenone or flecainide. One hundred seventy-six patients (46% men, 72 +/- 8 years) were enrolled. Device diagnostics continuously monitored AT recurrences and duration. RESULTS: In a mean follow-up of 20 +/- 9 months, the primary end point occurred in 23 (30.7%) of 75 class IC patients and in 28 (40.0%) of 70 amiodarone patients. The absolute difference in the end point incidence (-9.3%; 95% CI between 3.7% and -22.3%) confirmed the noninferiority of class IC to amiodarone (P = .007). Kaplan-Meier 1-year freedom from AT episodes >10 minutes, 1 day, and 7 days was 40%, 73%, and 91% for amiodarone and 28%, 78%, and 86% for class IC AADs (P = nonsignificant). CONCLUSIONS: In patients paced for SND and suffering from AT, class IC AADs proved not to be inferior to amiodarone in terms of the primary composite end point described or end points which were differently composed of mortality, efficacy, or AAD side effects. The AADs studied also showed similar results in terms of symptoms, quality of life, and freedom from AT recurrences.

2008 - Antiarrhythmic effect of reverse ventricular remodeling induced by cardiac resynchronization therapy: the InSync ICD (Implantable Cardioverter-Defibrillator) Italian Registry. [Articolo su rivista]
Di Biase, L; Gasparini, M; Lunati, M; Santini, M; Landolina, M; Boriani, Giuseppe; Curnis, A; Bocchiardo, M; Vincenti, A; Denaro, A; Valsecchi, S; Natale, A; Padeletti, L; InSync/InSync ICD Italian Registry, Investigators
abstract

We investigated whether the reverse remodeling after cardiac resynchronization therapy (CRT) might reduce the occurrence of ventricular arrhythmias (VAs).

2008 - Antiarrhythmic effect of reverse ventricular remodelling induced by cardiac resynchronization therapy [Artigo recomendado do mês] [Articolo su rivista]
Di Biase, Luigi; Gasparini, Maurizio; Lunati, Maurizio; Santini, Massimo; Ladolina, Maurizio; Boriani, Giuseppe; Curnis, Antonio; Bocchiardo, Mario; Vicenti, Antonio; Denaro, Alessandra; Valsecchi, Sergio; Natale, Andrea; Padeletti, Luigi
abstract

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2008 - Assessment of regional left ventricular function by radionuclide angiography in CRT patients. Proceedings 16th World Congress in Cardiac Electrophysiology and Cardiac Techniques [Articolo su rivista]
C., Valzania; F., Fallani; G., Gavaruzzi; M., Biffi; C., Martignani; M., Bertini; I., Diemberger; D., Saporito; M., Ziacchi; G., Domenichini; E., Cervi; R., Franchi; Boriani, Giuseppe
abstract

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2008 - Atrial fibrillation ablation: beyond electro-mechanical matters [Articolo su rivista]
Martignani, C; Diemberger, I; Biffi, M; Valzania, C; Bertini, M; Domenichini, G; Boriani, Giuseppe
abstract

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2008 - Atrial fibrillation in heart failure patients undergoing resynchronization therapy: what decision making? Proceedings 16th World Congress in Cardiac Electrophysiology and Cardiac Techniques [Articolo su rivista]
D., Saporito; M., Biffi; C., Martignani; C., Valzania; I., Diemberger; M., Bertini; G., Domenichini; M., Ziacchi; E., Cervi; C., Moschini; Boriani, Giuseppe
abstract

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2008 - Automatic management of left ventricular pacing output: effectiveness of stimulation and device longevity. Proceedings XIII International symposium on Progress in Clinical Pacing [Abstract in Rivista]
M., Biffi; M., Bertini; D., Saporito; M., Ziacchi; S., Stabellini; S., Valsecchi; V., Ricci; Boriani, Giuseppe
abstract

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2008 - Automatic verification of ventricular stimulation: fusion management algorithm [Articolo su rivista]
Bertini, M; Biffi, M; Ziacchi, M; Valzania, C; Saporito, D; Boriani, Giuseppe
abstract

Ventricular stimulation with automatic control and back-up pulse warrants maximum safety for the patient and increases device longevity. Fusion phenomenon may hinder evoked response (ER) detection and cause unnecessary back-up stimulation. We evaluated an automatic fusion beat management algorithm and its relationship with atrioventricular (AV) interval programming in a DDD/R pacemaker.

2008 - Can we improve risk stratification for thromboembolic events in atrial fibirillation by combining arrhythmia presence and duration with CHADS2 score? Poster European Congress of Cardiology 2008 [Articolo su rivista]
Boriani, Giuseppe; L., Padeletti; M., Santini; A., Capucci; M., Gulizia; F., Zolezzi; S., Favale; G., Molon; G., Corbucci; Botto, G. L.
abstract

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2008 - Cardiac resynchronization therapy during rest and exercise: comparison of two optimization methods. Proceedings 16th World Congress in Cardiac Electrophysiology and Cardiac Techniques [Articolo su rivista]
C., Valzania; Eriksson, M. J.; Boriani, Giuseppe; F., Gadler
abstract

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2008 - Cardiac resynchronization therapy during rest and exercise: comparison of two optimization methods. [Articolo su rivista]
Valzania, C; Eriksson, Mj; Boriani, Giuseppe; Gadler, F.
abstract

Optimal exercise programming of cardiac resynchronization therapy (CRT) devices is unknown. We aimed to: (i) investigate variations in optimal atrioventricular (AV) and interventricular (VV) delays from rest to exercise, assessed by both echocardiography and an automated intracardiac electrogram (IEGM) method; (ii) evaluate the acute haemodynamic impact of CRT optimization performed during exercise.

2008 - Case of polymorphic ventricular tachycardia after stroke necessitating defibrillation [Articolo su rivista]
VAN GELDER, Ic; EHRA EDUCATION, Committee; Boriani, Giuseppe; Ernst, S; Heidbuchel, H; Zaza, A; Mäkijärvi, M; Gorenek, B; Lundquist, C. B.
abstract

This case describes the occurrence of a tachycardia occurring early after a subarachnoid haemorrhage.

2008 - Case of the month by the EHRA Education committee: exercise-related arrhythmias. [Articolo su rivista]
Van Gelder, Ic; Boriani, Giuseppe; Ernst, S; Heidbuchel, H; Zaza, A; Mäkijärvi, M; Gorenek, B; Lundquist, Cb
abstract

This case describes two nephews with exercise-related arrhythmias

2008 - Clinical response to either biventrcular or left ventricular only pacing for cardiac resynchronization therapy: results of the double-blind randomized BLEFT-HF study. Presentation European Congress of Cardiology 2008 [Articolo su rivista]
Boriani, Giuseppe; W., Kranig; E., Donal; L., Calo; P., Zecchi; N., Delarche; I., Lozano; G., Ansalone; E., Boulogne
abstract

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2008 - Clinical usefulness of the left ventricular capture management (LVCM) algorithm. Proceedings 16th World Congress in Cardiac Electrophysiology and Cardiac Techniques [Articolo su rivista]
M., Biffi; M., Bertini; M., Ziacchi; S., Stabellini; E., Mazzini; T., Desanto; C., Martignani; Boriani, Giuseppe
abstract

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2008 - Comparison of two strategies to reduce ventricular pacing in pacemaker patients [Articolo su rivista]
Pürerfellner, H; Brandt, J; Israel, C; Sheldon, T; Johnson, J; Tscheliessnigg, K; Sperzel, J; Boriani, Giuseppe; Puglisi, A; Milasinovic, G.
abstract

Managed Ventricular Pacing (MVP) and Search AV+ (SAV+) are two pacing algorithms designed to reduce ventricular pacing. MVP promotes conduction by operating in AAI/R mode with backup ventricular pacing during atrioventricular block (AVB). SAV+ operates in DDD/R mode with a nominal AV extension of 290 ms during atrial sensing and 320 ms during atrial pacing. The reduction in ventricular pacing was compared with these two algorithms in pacemaker patients.

2008 - Comparison of two strategies to reduce ventricular pacing in pacemaker patients (PACE - Pacing and Clinical Electrophysiology (2008) 31, 2, (167-176) DOI: 10.1111/j.1540-8159.2007.00965.x) [Articolo su rivista]
Pürerfellner, Helmut; Brandt, Johan; Israel, Carsten; Sheldon, Todd; Johnson, James; Tscheliessnigg, Karlheinz; Sperzel, Johannes; Boriani, Giuseppe; Puglisi, Andrea; Milasinovic, Goran
abstract

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2008 - Confronto tra metodi standard per il rilevamento della fibrillazione atriale e il monitoraggio continuo [Articolo su rivista]
Boriani, Giuseppe; L., Padeletti; M., Santini; A., Capucci; Gulizia, M. M.; F., Zolezzi; S., Favale; G., Molon; R., Ricci; M., Biffi; G., Russo; M., Vimercati; G., Corbucci; G., Botto
abstract

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2008 - Contribution of morphology discrimination algorithm for improving rhythm discrimination in slow and fast ventricular tachycardia zones in dual-chamber implantable cardioverter-defibrillators. [Articolo su rivista]
Boriani, Giuseppe; Occhetta, E; Cesario, S; Grossi, S; Marconi, M; Speca, G; Silvestri, P; Biffi, M; Bortnik, M; Martignani, C; Branzi, A.
abstract

Morphology discrimination (MD) is an algorithm based on QRS morphology analysis, that can be used alone or in various combinations with other discriminators in order to diagnose ventricular tachycardia (VT) [the implantable cardioverter-defibrillator (ICD) may be set to diagnose VT if 'Any' or 'All' the discriminators indicate VT)].

2008 - Effect of ECG filtering on time domain analysis of the P-Wave [Relazione in Atti di Convegno]
Censi, F.; Calcagnini, G.; Bartolini, P.; Cervi, E.; Diemberger, I.; Corazza, I.; Boriani, G.
abstract

The aim of this study was to assess the effect of filtering techniques on the time-domain analysis of the P-wave. Multi-lead ECG recordings obtained from chronic AF patients after successful external cardioversion have been acquired. Several high-pass filtering techniques and three cut-off frequency values were used: Bessel and Butterworth four-pole and two-pole bidirectional and unidirectional filters, at 0.01, 0.05 and 0.5 Hz low cut-off frequency. As a reference, a beat-by-beat linear piecewise interpolation was used to remove baseline wander, on each P-wave. Results show that ECG filtering affects the estimation of P-wave duration in a manner that depends upon the type of filter used: particularly, the bidirectional filters caused negligible variation of P- wave duration, while unidirectional ones provoked an increase higher than 8%.

2008 - Effects of cardiac resynchronization therapy on coronary blood flow: Evaluation by transthoracic Doppler echocardiography. [Articolo su rivista]
Valzania, C; Gadler, F; Winter, R; Braunschweig, F; Brodin, La; Gudmundsson, P; Boriani, Giuseppe; Eriksson, M. J.
abstract

Relatively limited and conflicting data are available on the effects of cardiac resynchronization therapy (CRT) on coronary blood flow (CBF).

2008 - Electrical storm in patients with biventricular implantable cardioverter defibrillator: Incidence, predictors, and prognostic implications. [Articolo su rivista]
Gasparini, M; Lunati, M; Landolina, M; Santini, M; Padeletti, L; Perego, G; Vincenti, A; Curnis, A; Carboni, A; Denaro, A; Spotti, A; Grammatico, A; Regoli, F; Boriani, Giuseppe; on behalf of the InSync ICD Italian Registry, Investigators
abstract

The aim of the present study was to evaluate the incidence, predictors, and related outcomes of patients with heart failure (HF) treated with cardiac resynchronization therapy with an implantable cardioverter defibrillator (CRT-D) who experienced electrical storm (ES). Electrical storm was defined as the occurrence of >or=3 episodes in 24 hours of sustained ventricular tachyarrhythmias.

2008 - Electrophysiological inducibility does not predict ventricular arrhythmia occurrence in post MI cardiomyopathy. Proceedings XIII International symposium on Progress in Clinical Pacing [Articolo su rivista]
M., Russo; Boriani, Giuseppe; M., Lunati; G., Botto; A., Proclemer; W., Rahue; S., Toscano; G., Vergara; A., Curnis; M., Merico; L., Larocca; M., Santi
abstract

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2008 - Fibrillazione atriale e chiusura transcatetere del forame ovale pervio: quale correlazione? Abstract 69° Congresso Nazionale Società Italiana di Cardiologia [Articolo su rivista]
C., D’Angelo; G., Bronzetti; A., Donti; A., Giardini; L., Salomone; E., Mariucci; Boriani, Giuseppe; Picchio, F. M.
abstract

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2008 - Fibrillazione atriale e terapia di resincronizzazine cardiaca: quale strategia? Abstract 69° Congresso Nazionale Società Italiana di Cardiologia [Articolo su rivista]
D., Saporito; M., Ziacchi; E., Cervi; G., Domenichini; C., Moschini; M., Biffi; C., Martignani; C., Valzania; Boriani, Giuseppe; A., Branzi
abstract

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2008 - Follow up a lungo termine di pazienti con sincope valutati con tilt test. Abstract 69° Congresso Nazionale Società Italiana di Cardiologia [Articolo su rivista]
G., Domenichini; I., Diemberger; C., Valzania; M., Bertini; D., Saporito; M., Ziacchi; A., Marziali; C., Martignani; M., Biffi; Boriani, Giuseppe; A., Branzi
abstract

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2008 - Heart transplantation in hypertrophic cardiomyopathy. [Articolo su rivista]
Biagini, E; Spirito, P; Leone, O; Picchio, Fm; Coccolo, F; Ragni, L; Lofiego, C; Grigioni, F; Potena, L; Rocchi, G; Bacchi Reggiani, L; Boriani, Giuseppe; Prandstraller, D; Arbustini, E; Branzi, A; Rapezzi, C.
abstract

Heart transplantation (HT) is the sole therapeutic option for selected patients with hypertrophic cardiomyopathy (HC) and refractory heart failure. However, the results of HT have not been systematically investigated in HC. We assessed the pathophysiologic profile of HT candidates and the outcome after transplantation in 307 patients with HC consecutively evaluated at our tertiary referral center from 1987 to 2005; follow-up was 9.9+8.2 years. Outcome of recipients with HC was compared with that of 141 patients who underwent transplantation for idiopathic dilated cardiomyopathy at our center over the same period. Of 21 patients with HC who entered the transplantation list, 20 had end-stage evolution with systolic dysfunction and 1 had an extremely small left ventricular cavity with impaired filling and recurrent cardiogenic shock during paroxysmal atrial fibrillation. Of 33 study patients with HC who showed end-stage evolution during follow-up, the 23 who were included on the waiting list or died from refractory heart failure (2 patients) were significantly younger than the 10 patients who remained clinically stable (37+/-14 vs 57+/-17 years, p=0.004). Of the 21 HT candidates, 18 underwent transplantation during follow-up. In heart transplant recipients, 7-year survival rate was 94% and not different from that of the 141 patients who received transplants for idiopathic dilated cardiomyopathy (p=0.66). In conclusion, long-term outcome after HT in patients with HC is favorable and similar to that of patients with idiopathic dilated cardiomyopathy. In patients with end-stage HC, young age is associated with more rapid progression to refractory heart failure.

2008 - How to assess the efficacy of catheter ablation of atrial fibrillation? [Articolo su rivista]
Martignani, C; Diemberger, I; Biffi, M; Valzania, C; Bertini, M; Boriani, Giuseppe
abstract

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2008 - ICD cost is related to device longevity. Proceedings 16th World Congress in Cardiac Electrophysiology and Cardiac Techniques [Articolo su rivista]
M., Biffi; M., Ziacchi; M., Bertini; D., Saporito; C., Valzania; G., Domenichini; C., Moschini; E., Cervi; I., Diemberger; C., Martignani; Boriani, Giuseppe
abstract

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2008 - ICD longevity: a comparison among manufacturers. Proceedings XIII International symposium on Progress in Clinical Pacing [Articolo su rivista]
M., Biffi; M., Ziacchi; M., Bertini; D., Saporito; C., Valzania; G., Domenichini; C., Moschini; E., Cervi; C., Martignani; I., Diemberger; Boriani, Giuseppe
abstract

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2008 - Il follow up di pacemaker e defibrillatore: quali disagi per pazienti e famigliari?, quale potenziale impatto della telemedicina? [Articolo su rivista]
M., Salomoni; M., Balbo; F., Bonfatti; J., Frisoni; M., Biffi; C., Martignani; Boriani, Giuseppe
abstract

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2008 - Indici predittivi dell’efficacia della terapia di resincronizzazione cardiaca mediante valutazone della capacità funzionale cardiorespiratoria. Abstract 69° Congresso Nazionale Società Italiana di Cardiologia [Abstract in Rivista]
E., Filippini; E., Barbaresi; S., Stabellini; D., Saporito; L., Bacchi Reggiani; Boriani, Giuseppe; S., Specchia; A., Branzi
abstract

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2008 - Interventricular delay interval optimization in cardiac resynchronization therapy guided by echocardiography versus guided by electrocardiographic QRS interval width. [Articolo su rivista]
Bertini, M; Ziacchi, M; Biffi, M; Martignani, C; Saporito, D; Valzania, C; Diemberger, I; Cervi, E; Frisoni, J; Sangiorgi, D; Branzi, A; Boriani, Giuseppe
abstract

Present devices for cardiac resynchronization therapy offer the possibility of tailoring the hemodynamic effect of biventricular pacing by optimization of the interventricular delay (VV) beyond atrioventricular (AV)-interval optimization. It was not yet defined whether a QRS width-based strategy may be a helpful tool for echocardiography for device programming. The aim of the study was to investigate the relation between VV-interval optimization guided by echocardiography and guided by QRS interval width. One hundred six patients with a cardiac resynchronization therapy device for > or =3 months were enrolled. All patients underwent echocardiographic AV and VV delay optimization. The AV interval was optimized according to the E wave-A wave (EA) interval and left ventricular filling time. At the optimal AV delay, VV optimization was performed by measuring the aortic velocity time integral at 5 different settings: simultaneous right and left ventricle output, left ventricle pre-excitation (left ventricle + 40 and 80 ms, respectively), and right ventricle pre-excitation (right ventricle + 40 and 80 ms, respectively). A 12-lead electrocardiogram was recorded and QRS duration was measured in the lead with the greatest QRS width. The electrocardiographic (ECG)-optimized VV interval was defined according to the narrowest achievable QRS interval among 5 VV intervals. The echocardiographic-optimized VV interval was left ventricle + 40 ms in 28 patients, left ventricle + 80 ms in 15 patients, simultaneous in 46 patients, right ventricle + 40 ms in 14 patients, and right ventricle + 80 ms in 3 patients. Significant concordance (kappa = 0.69, p <0.001) was found between the echocardiographic- and ECG-optimized VV interval. In conclusion, significant concordance appeared to exist during biventricular pacing between VV programming based on the shortest QRS interval at 12-lead ECG pacing and echocardiographic-guided VV-interval optimization. A combined ECG- and echocardiographic approach could be a less time-consuming solution in performing this operation.

2008 - La longevità dei defibrillatori impiantabili: implicazioni cliniche ed economiche. Abstract 69° Congresso Nazionale Società Italiana di Cardiologia [Articolo su rivista]
M., Biffi; M., Ziacchi; M., Bertini; D., Sangiorgi; D., Corsini; D., Saporito; I., Diemberger; C., Martignani; C., Valzania; C., Moschini; E., Cervi; G., Domenichini; A., Marziali; A., Branzi; Boriani, Giuseppe
abstract

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2008 - Left ventricular versus biventricular pacing: a randomized comparative study evaluating mid-term electromechanical and clinical effects. [Articolo su rivista]
Valzania, C; Rocchi, G; Biffi, M; Martignani, C; Bertini, M; Diemberger, I; Biagini, E; Ziacchi, M; Domenichini, G; Saporito, D; Rapezzi, C; Branzi, A; Boriani, Giuseppe
abstract

Although left ventricular (LV) pacing has been proposed as an alternative to biventricular (BIV) pacing for heart failure (HF) patients, few comparative data are available on the electromechanical effects of these pacing modalities at mid-term follow-up.

2008 - Letter by Boriani et al regarding article, "Death without prior appropriate implantable cardioverter-defibrillator therapy: a competing risk study" [Articolo su rivista]
Boriani, Giuseppe; Diemberger, I; Grigioni, F.
abstract

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2008 - Local amyloidosis as a possible component of the atrial remodeling accompanying atrial fibrillation. [Articolo su rivista]
O., Leone; Boriani, Giuseppe; G., Marinelli; C., Rapezzi
abstract

In their extensive state-of-the-art paper on the clinical implications for atrial fibrillation of structural and functional remodeling of the left atrium.

2008 - Long term follow up of patients with sincope evaluated by head up til test. Proceedings 16th World Congress in Cardiac Electrophysiology and Cardiac Techniques [Articolo su rivista]
G., Domenichini; I., Diemberger; M., Biffi; C., Martignani; C., Valzania; M., Bertini; M., Ziacchi; D., Saporito; A., Branzi; Boriani, Giuseppe
abstract

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2008 - Longevity of implantable cardioverter-defibrillators: implications for clinical practice and health care systems. [Articolo su rivista]
Biffi, M; Ziacchi, M; Bertini, M; Sangiorgi, D; Corsini, D; Martignani, C; Diemberger, I; Boriani, Giuseppe
abstract

Comparative studies on the longevity of implantable cardioverter-defibrillators (ICDs) among different manufacturers have never been reported. Longevity of ICD devices implanted from 1 January 2000 to 31 December 2002 was prospectively investigated according to their type and manufacturer.

2008 - May we improve risk stratification for thromboembolic events by combining CHADS2 score with atrial fibrillation presence and duration? Proceedings 16th World Congress in Cardiac Electrophysiology and Cardiac Techniques [Articolo su rivista]
Botto, G. L.; L., Padeletti; M., Santini; A., Capucci; M., Gulizia; F., Zolezzi; S., Favale; G., Molon; R., Ricci; M., Biffi; B., Mariconti; M., Vimercati; G., Corbucci; Boriani, Giuseppe
abstract

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2008 - Modificazioni del flusso muscolare periferico in pazienti sottoposti a terapia di resincronizzazione cardiaca e confronto col rimodellamento ventricolare. Abstract 69° Congresso Nazionale Società Italiana di Cardiologia [Articolo su rivista]
I., Diemberger; I., Corazza; J., Frisoni; C., Martignani; M., Biffi; C:valzania, ; M., Bertini; G., Domenichini; A., Marziali; R., Zannoli; A., Branzi; Boriani, Giuseppe
abstract

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2008 - Non invasive evaluation of functional and hemodynamic capacity: efficacy and reliability in CRT patients. Proceedings XIII International symposium on Progress in Clinical Pacing [Abstract in Rivista]
E., Barbaresi; N., Rizzo; A., Balducci; S., Stabellini; L., Bacchi Reggiani; E., Filippini; S., Specchia; Boriani, Giuseppe; A., Branzi
abstract

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2008 - Optimization of VV delay in devices for cardiac resynchronization therapy: a prospective randomized study. Poster European Congress of Cardiology 2008 [Articolo su rivista]
Boriani, Giuseppe; M., Biffi; K. H., Seidl; R., Grove; J., Vogt; W., Danshel; A., Schuckert; Deharo, J. C.; Muller, C. P.; T., Becker; E., Boulogne; Trappe, H. J. J.
abstract

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2008 - Ottimizzazione del’intervallo interventricolare nei dispositivi per resicronizzazione cardiaca: studio prospettico di confronto fra tre diverse metodiche ecocardiografiche. Abstract 69° Congresso Nazionale Società Italiana di Cardiologia [Articolo su rivista]
M., Bertini; C., Valzania; M., Biffi; C., Martignani; G., Domenichini; M., Ziacchi; I., Diemberger; D., Saporito; A., Marziali; S., Pedri; A., Branzi; Boriani, Giuseppe
abstract

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2008 - Patients with previous sincope evaluated with head up til test : long term follow up. Poster European Congress of Cardiology 2008 [Articolo su rivista]
Boriani, Giuseppe; G., Domenichini; I., Diemberger; M., Biffi; C., Martignani; C., Valzania; M., Bertini; D., Saporito; M., Ziacchi; A., Branzi
abstract

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2008 - Persistent atrial fibrillation worsens heart rate variability, activity and heart rate, as shown by a continuous monitoring by implantable biventricular pacemakers in heart failure patients. [Articolo su rivista]
Puglisi, A; Gasparini, M; Lunati, M; Sassara, M; Padeletti, L; Landolina, M; Botto, Gl; Vincenti, A; Bianchi, S; Denaro, A; Grammatico, A; Boriani, Giuseppe
abstract

Atrial fibrillation (AF) induces loss of atrial contribution, heart rate irregularity, and fast ventricular rate.

2008 - Prolonged QRS and QTc interval and mortality [Articolo su rivista]
Grigioni, F; Piovaccari, G; Boriani, Giuseppe
abstract

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2008 - Prophylactic ICD in female versus male post-infarction patients: data from a real-world registry. Poster European Congress of Cardiology 2008 [Articolo su rivista]
Boriani, Giuseppe; M., Biffi; Botto, G. L.; M., Lunati; A., Proclemer; B., Schmidt; A., Erdogan; W., Rahue; M., Messier; M., Santini
abstract

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2008 - Response to resynchronization therapy accordino to the degree of functional impairment at cardiopulmonary exercise testing. Proceedings 16th World Congress in Cardiac Electrophysiology and Cardiac Techniques [Articolo su rivista]
Boriani, Giuseppe; D., Saporito; M., Biffi; C., Martignani; C., Valzania; I., Diemberger; M., Bertini; G., Domenichini; M., Ziacchi; E., Cervi; F., Grigioni; S., Specchia; A., Branzi
abstract

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2008 - Results from the RELEVANT study: shockless programming is safe and effective in patients with non ischemic heart failure. Presentation European Congress of Cardiology 2008 [Articolo su rivista]
Boriani, Giuseppe; A., Proclemer; C., Menozzi; M., Landolina; S., Iacopino; M., Biffi; E., Lombardi; A., Denaro; A., Varbaro; M., Gasparini
abstract

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2008 - Rhythm discrimination by analysis of QRS morphology in biventricular cardioverter defibrillators. Proceedings 16th World Congress in Cardiac Electrophysiology and Cardiac Techniques [Articolo su rivista]
Boriani, Giuseppe; M., Biffi; C., Martignani; C., Valzania; I., Diemberger; M., Bertini; D., Saporito; M., Ziacchi; G., Domenichini; E., Cervi; P., Silvestri; A., Branzi
abstract

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2008 - Si puo’ migliorare la stratificazione del rischio tromboembolico combinando il CHADS2 score con presenza e durata della fibrillazione atriale? [Articolo su rivista]
G., Botto; L., Padeletti; M., Santini; A., Capucci; Gulizia, M. M.; F., Zolezzi; S., Favale; G., Molon; R., Ricci; M., Biffi; B., Mariconti; M., Vimercati; G., Corbucci; Boriani, Giuseppe
abstract

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2008 - Standard methods fora atrial fibrillation detection compared to continuous monitoring. Poster European Congress of Cardiology 2008 [Articolo su rivista]
Botto, G. L.; L., Padeletti; M., Santini; A., Capucci; M., Gulizia; F., Zolezzi; S., Favale; G., Molon; M., Vimercati; Boriani, Giuseppe
abstract

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2008 - Strategy for a genetic assessment of antipsychotic and antidepressant-related proarrhythmia. [Articolo su rivista]
Drago, A; De Ponti, F; Boriani, Giuseppe; De Ronchi, D; Serretti, A.
abstract

Antidepressants and antipsychotics may affect several ion channels involved in the control of cardiac action potential and be proarrhythmic. In this field, accurate understanding of genetics, which per se is a non-controllable risk factor, may help clinicians to prevent life-threatening side effects. So far, a number of genes have been associated with arrhythmia: SCN5A, SCN4B, CACNL1AC, KCNH2, KCNQ1, KCNE1, ANK2, ALG10, KCNJ2, KCNE2, RYR2, KCND3, KCND2, ACE, NOS1AP, CASQ2 and Rad. These genes represent good candidates for the definition of a genetic pro-arrhythmic profile. A genetic analysis of these targets is provided and their possible pathophysiological role in arrhythmias is discussed. Special attention is devoted to the interactions between these genes and new generation antidepressants and antipsychotics. A list of relevant rare mutations within the selected genes is presented, together with a complete list of Tag SNPs covering the whole genetic sequence. The aim of this paper is to define a part of the genetic framework responsible for the proarrhythmic effects of antidepressants and antipsychotics. The selected variants, both mutations and polymorphisms, may help in defining a next-to-come genetic assessment to be performed before drug prescription in order to improve drug safety.

2008 - Telecardiology and remote monitoring of implanted electrical devices: the potential for fresh clinical care perspectives. [Articolo su rivista]
Boriani, Giuseppe; Diemberger, I; Martignani, C; Biffi, M; Valzania, C; Bertini, M; Domenichini, G; Saporito, D; Ziacchi, M; Branzi, A.
abstract

Telecardiology may help confront the growing burden of monitoring the reliability of implantable defibrillators/pacemakers. Herein, we suggest that the evolving capabilities of implanted devices to monitor patients' status (heart rhythm, fluid overload, right ventricular pressure, oximetry, etc.) may imply a shift from strictly device-centered follow-up to perspectives centered on the patient (and patient-device interactions). Such approaches could provide improvements in health care delivery and clinical outcomes, especially in the field of heart failure. Major professional, policy, and ethical issues will have to be overcome to enable real-world implementation. This challenge may be relevant for the evolution of our health care systems.

2008 - The Drug And Pace Health cliNical Evaluation (DAPHNE) study: A randomized trial comparing sotalol versus β-blockers to treat symptomatic atrial fibrillation in patients with brady-tachycardia syndrome implanted with an antitachycardia pacemaker [Articolo su rivista]
Capucci, A; Botto, G; Molon, G; Spampinato, A; Favale, S; Proclemer, A; Porfilio, A; Marotta, T; Vimercati, M; Boriani, Giuseppe
abstract

Atrial tachyarrhythmias (ATAs) are mainly treated by pharmacologic therapy for rate control or rhythm control. The aim of our study was to compare sotalol (S) versus beta-blocking agents (BB) in terms of prevention of ATA, cardioversions (CVs), and cardiovascular hospitalizations (H) in patients paced for bradycardia-tachycardia form of sinus node disease (BT-SND).

2008 - The MINERVA study design and rationale: A controlled randomized trial to assess the clinical benefit of minimizing ventricular pacing in pacemaker patients with atrial tachyarrhythmias [Articolo su rivista]
Funck, Rc; Boriani, Giuseppe; Manolis, As; Püererfellner, H; Mont, L; Tukkie, R; Pisapia, A; Israel, Cw; Grovale, N; Grammatico, A; Padeletti, L.
abstract

Dual-chamber (DDD) pacing has generally been regarded as "physiologic pacing" and therefore expected to be superior to ventricular pacing. Major randomized trials have so far failed to demonstrate significant reductions in the incidences of mortality, stroke, and heart failure. It has been shown that unnecessary ventricular pacing in patients with sinus node dysfunction or only intermittent atrioventricular block is associated with ventricular desynchronization and increased risk of atrial tachyarrhythmias (ATA).

2008 - The cost of ICD therapy is dependent on device longevity. Proceedings XIII International symposium on Progress in Clinical Pacing [Articolo su rivista]
M., Biffi; M., Ziacchi; M., Bertini; D., Saporito; C., Valzania; G., Domenichini; C., Moschini; E., Cervi; C., Martignani; I., Diemberger; Boriani, Giuseppe
abstract

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2008 - The impact of quality of life scores in patients implanted with defibrillatoors for primary prevention of sudden cardiac death. Proceedings XIII International symposium on Progress in Clinical Pacing [Articolo su rivista]
M., Russo; M., Santini; Boriani, Giuseppe; G., Botto; M., Lunati; A., Proclemer; W., Rahue; G., Vergara; S., Toscano; M., Merico
abstract

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2008 - Troponin I levels and pacemaker implantation: what clinical implications? Proceedings 16th World Congress in Cardiac Electrophysiology and Cardiac Techniques [Articolo su rivista]
C., Martignani; M., Ziacchi; D., Saporito; M., Bertini; M., Biffi; I., Diemberger; C., Valzania; G., Domenichini; E., Cervi; A., Branzi; Boriani, Giuseppe
abstract

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2008 - Uneventful right ventricular perforation with displacement of a pacing lead into the left thorax. [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Martignani, C.
abstract

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2008 - Ventricular dyssynchrony at echo: Detection by two-dimensional tracking and tissue Doppler imaging in candidates to biventricular pacing [Relazione in Atti di Convegno]
Valzania, C.; Bertini, M.; Pedri, S.; Domenichini, G.; Frisoni, J.; Ziacchi, M.; Biffi, M.; Martignani, C.; Diemberger, I.; Corazza, I.; Pedrizzetti, G.; Boriani, G.
abstract

Left ventricular (LV) dyssynchrony is a predictor of response to biventricular (BiV) pacing in patients with heart failure (HF) and LV dysfunction. In this study we compared a novel two-dimensional speckle tracking technique to standard Tissue Doppler Imaging (TDI) with regard to LV dyssynchrony assessment in 10 HF patients candidated to BiV pacing. Substantial correlation was found between the two techniques in measuring LV dyssynchrony (r=0.69; p<0,05). Two-dimensional speckle tracking was able to detect variations in LV dyssynchrony induced by simultaneous BiV pacing. This pilot evaluation suggests that two-dimensional speckle tracking may be a valuable alternative to standard TDI to assess LV dyssynchrony before implant and during follow up in candidates to BiV pacing.

2008 - Ventricular dyssynchrony at rest and during exercise assessed by radionuclide angiography in CRT patients. Proceedings 16th World Congress in Cardiac Electrophysiology and Cardiac Techniques [Articolo su rivista]
C., Valzania; F., Fallani; G., Gavaruzzi; M., Biffi; C., Martignani; M., Bertini; I., Diemberger; D., Saporito; M., Ziacchi; G., Domenichini; E., Cervi; R., Franchi; Boriani, Giuseppe
abstract

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2007 - Atrial threshold variability: implications for automatic atrial stimulation algorithms. [Articolo su rivista]
Biffi, M; Spitali, G; Silvetti, Ms; Argnani, S; Rubino, I; Fontana, P; Barbato, G; Mazzini, E; De Santo, T; Drago, F; Boriani, Giuseppe
abstract

Automatic management of atrial stimulation by verification of atrial threshold (ACM) has recently been made feasible. We investigated circadian atrial threshold variability over the long term and the predictors of successful automatic atrial threshold measurement, in order to provide practical clues for programming ACM features, in such a way as to achieve daily threshold verification and > 99% effective atrial stimulation.

2007 - Biventricular ICDs and rhythm discrimination by analysis of QRS morphology: are there QRS changes associated with left ventricular reverse remodeling? Poster European Congress of Cardiology 2007 [Articolo su rivista]
Boriani, Giuseppe; M., Biffi; C., Martignani; C., Valzania; I., Diemberger; M., Bertini; D., Saporito; M., Ziacchi; P., Silvestri; A., Branzi
abstract

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2007 - Cardiac resynchronization therapy in clinical practice: Need for electrical, mechanical, clinical and logistic synchronization. [Articolo su rivista]
Boriani, Giuseppe; Diemberger, I; Biffi, M; Martignani, C; Valzania, C; Ziacchi, M; Bertini, M; Specchia, S; Grigioni, F; Rapezzi, C; Branzi, A.
abstract

Considering the relatively short history of cardiac resynchronization therapy (CRT), the amount of available evidence of efficacy is impressive, and effectiveness studies are now required. Transfer of our experimentally gained knowledge into the real world raises issues that call for synchronization among the many specialists involved in chronic heart failure (CHF) management and CRT decision making. From an economic perspective, the demonstrated ability of CRT to reduce hospitalizations could help ease the burden on health systems derived from the growing incidence of CHF. Recent American College of Cardiology/American Heart Association guideline revisions should encourage a synchronized approach to rational deployment of CRT in selected patients. Nevertheless, current QRS criteria for CRT candidacy do not directly address the key issue of identification of patients with a pacing-correctable mechanical dyssynchrony (and in clinical trials, 25-30% of implanted patients did not respond to CRT). Echocardiography could become an important adjunct (or even an alternative) to QRS duration for patient selection; routine implementation would require use of straightforward, reproducible measurements, possibly obtainable on standard equipment. Echocardiography could also help optimize site location, although this would not eliminate lead placement problems. A series of issues remain open for investigation, including the potential of CRT in patients with atrial fibrillation, impact of devices with defibrillation ability, effects of electrical/pharmacological tailoring, need for confirmation that efficacy of CRT extends into the long term and possible use of CRT in mild CHF. Interdisciplinary synchronization in the various phases of CRT (screening, proposing, implementing, optimizing and monitoring) should eventually help develop a coordinated system for patient referral.

2007 - Cardiac resynchronization therapy: Variations in echo-guided optimized atrioventricular and interventricular delays during follow-up [Articolo su rivista]
Valzania, C; Biffi, M; Martignani, C; Diemberger, I; Bertini, M; Ziacchi, M; Bacchi, L; Rocchi, G; Rapezzi, C; Branzi, A; Boriani, Giuseppe
abstract

Abstract BACKGROUND: Relatively few data are available on long-term echocardiographic optimization of atrioventricular (AV) and interventricular (VV) delay programming in cardiac resynchronization therapy (CRT). We assessed variations in optimized AV and VV delays during long-term follow-up. METHODS: Thirty-seven consecutive heart failure patients received Doppler echocardiographic optimization of AV and VV delay within 48 hours from CRT device implantation, at 6 months and at 12 months (the last for the first enrolled 14 patients). RESULTS: After implantation, median optimized AV delay was 100 ms (range, 45 ms); VV optimization led to simultaneous biventricular activation in 4 patients, left ventricular preactivation in 17 patients and right ventricular preactivation in 16 patients. At 12 months median AV delay decreased to 85 ms (23 ms) (P < 0.05 vs. baseline). With respect to previous assessment, VV delay variations > or =40 ms were observed in 41% of the patients at 6 months and in 57% of the tested patients at 12 months. A nonconcordance (by Kappa test) of optimized VV delays was found between each new assessment and the previous one. VV delay optimization was associated with significant (P < 0.001) increases in aortic velocity time integral both at baseline and during follow-up. CONCLUSIONS: Echocardiographic optimization of AV and VV delay is associated with broad intraindividual variability during follow-up. A new assessment of optimized VV delays during long-term follow-up reveals a nonconcordance with previous values and provides increases in forward stroke volume.

2007 - Cardioverter defibrillators in primary prevention of sudden cardiac death: a cost or an investment? [Articolo su rivista]
Boriani, Giuseppe
abstract

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2007 - Celebrating 50 years of electrical therapies for the heart [Articolo su rivista]
Boriani, Giuseppe; Linde, C; Sutton, R.
abstract

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2007 - Clinical and arrhythmic outcomes of patients with post- myocardial infarction cardiomyopathy treated with implantable defibrillators for primary prevention of sudden death: the Search-MI Registry. Abstract XIII World Congress on Cardiac Pacing and Electrophysiology [Articolo su rivista]
Boriani, Giuseppe; M., Santini; M., Russo; M. LUNATI G., Botto; A., Proclemer; A., Erdogan; B., Shmidt; W., Rahue; M., Desaga; E., Santi; M., Messier; M., Biffi
abstract

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2007 - Duration of P-wave is associated with atrial fibrillation hospitalizations in patients with atrial fibrillation and paced for bradycardia. [Articolo su rivista]
Padeletti, L; Santini, M; Boriani, Giuseppe; Botto, G; Ricci, R; Spampinato, A; Vergara, G; Rahue, Wg; Capucci, A; Gulizia, M; Pieragnoli, P; Grammatico, A; Platonov, P; Barold, S. S.
abstract

Atrial fibrillation (AF) is a common problem in pacemaker patients. We conducted a prospective observational study in patients paced for bradycardia with associated paroxysmal or persistent AF, to determine whether P-wave duration may stratify patients at higher risk for AF recurrences and AF-related hospitalizations. The patients were evaluated for the prevalence, cause, and predictors of hospitalization.

2007 - Effect of cardiac resynchronization therapy on coronary blood flow: evaluation by transthoracic echocardiography. Abstract Europace 2007 [Articolo su rivista]
C., Valzania; M. J., Eriksson; R., Winter; F., Braunschweig; P., Gudmunsson; Boriani, Giuseppe; F., Gadler
abstract

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2007 - Effects of cardiac resynchronization therapy on coronary blood flow: evaluation by transthoracic Doppler echocardiography. Poster European Congress of Cardiology 2007 [Articolo su rivista]
C., Valzania; M. J., Eriksson; R., Winter1; F., Braunschweig; P., Gudmundsson1; Boriani, Giuseppe; F., Gadler
abstract

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2007 - Effects of cardiac resynchronization therapy on diastolic function: evaluation by radionuclide angiography. [Articolo su rivista]
Boriani, Giuseppe; Valzania, C; Fallani, F; Biffi, M; Martignani, C; Saporito, D; Ziacchi, M; Diemberger, I; Greco, C; Bertini, M; Domenichini, G; Levorato, M; Franchi, R; Branzi, A.
abstract

While the beneficial effects of cardiac resynchronization therapy (CRT) on left ventricular (LV) systolic function have been demonstrated, no information is available regarding its effects on LV diastolic function during exercise. Using radionuclide angiography, we prospectively evaluated the effects of CRT on diastolic function at rest and during exercise in 15 patients consecutively referred for CRT. All patients underwent equilibrium Tc(99) radionuclide angiography with bicycle exercise performed (1) at baseline; (2) immediately after CRT implantation, in spontaneous rhythm and during CRT; and (3) after 3 months of biventricular stimulation. Diastolic function was assessed by measurements of peak filling rate (PFR). At baseline, activation of biventricular stimulation influenced PFR neither at rest (1.06 +/- 0.34 vs 1.07 +/- 0.50 mL/s during spontaneous rhythm, P = 0.9) nor during exercise (1.45 +/- 0.62 vs 1.33 +/- 0.48 mL/s, P = 0.3). At 3 months, improvements were observed in New York Heart Association functional class and systolic function. By contrast, no improvement in diastolic function was observed either at rest (PFR = 1.11 +/- 0.45 vs 1.07 +/- 0.50 mL/s in spontaneous rhythm at baseline, P = 0.6) or during exercise (1.23 +/- 0.50 vs 1.33 +/- 0.48 mL/s, P = 0.2). These observations indicate that the intermediate benefits conferred by CRT on LV systolic function at rest and during exercise were not accompanied by similar improvements in diastolic function

2007 - Electrical cardioversion for persistent atrial fibrillation or atrial flutter in clinical practice: predictors of long-term outcome. [Articolo su rivista]
Boriani, Giuseppe; Diemberger, I; Biffi, M; Domenichini, G; Martignani, C; Valzania, C; Branzi, A.
abstract

Despite the results of Atrial Fibrillation Follow-up Investigation of Rhythm Management and Rate Control versus Electrical Cardioversion for Persistent Atrial Fibrillation trials, which favour a general shift in atrial fibrillation (AF) therapeutic approach towards control of ventricular rate, a strategy based on restoration of sinus rhythm could still play a role in selected patients at lower risk of AF recurrence. We explored possible predictors of relapses after external electrical cardioversion among patients with persistent AF or atrial flutter (AFL). We analysed the clinical characteristics and conventional echocardiographic parameters of patients with persistent AF/AFL enrolled in an institutional electrical cardioversion programme. Among 242 patients (AF/AFL, 195/47; mean age 62+/-13 years), sinus rhythm was restored in 215 (89%) and maintained in 73 (34%) at a follow-up of 930 days (median). No baseline clinical/echocardiographic variables predicted acute efficacy of cardioversion at logistic regression analysis. However, two variables predicted long-term AF/AFL recurrence among patients with successful cardioversion at multivariate Cox's proportional hazards analysis: (i) duration of arrhythmia&gt;or=1 year (HR, 2.07; 95% CI, 1.29-3.33) and (ii) presence of previous cardioversion (HR, 1.67; 95% CI, 1.17-2.38). These variables also presented high-positive predictive values (72% and 80% respectively). Whereas the high acute efficacy of electrical cardioversion (approximately 90%) does not appear to be predictable, two simple clinical variables could help identify patients at higher risk of long-term AF/AFL recurrence after successful electrical cardioversion. We think there could be a case for initially attempting external electrical cardioversion to patients who have had AF/AFL for &lt;1 year. In such patients, the chance of long-term success appears to be relatively high.

2007 - Electrical therapies for the heart: a 50-year story projected into the future. [Curatela]
Boriani, Giuseppe; C., Linde; R., Sutton
abstract

Celebrating 50 years of electrical therapies for the heart Around Fifty years ago, on 8 October 1958, Elmqvist and Senning, at the Karolinska Hospital in Stockholm, implanted the first endocardial pacemaker to treat a patient with recurrent Adam–Stokes episodes.1 Since this pioneering experience, arrhythmia management has evolved enormously in the last 50 years, with electrophysiology being one of the areas of medicine where technology has had the strongest impact.2 The technologically driven evolution of devices and tools has been complemented by the acquisition of important scientific evidence of benefit in specific patient settings. Accumulation of hard evidence has allowed us to progress from pioneering experiences with pacemakers, implantable cardioverter-defibrillators (ICDs), and ablative techniques in very sick subjects treated in a handful of research centres to widespread routine use of such interventions in hundreds of thousands of patients around the world. The type of therapeutic target has also evolved: from ‘rescue’ interventions in high-risk conditions (complete atrioventricular block for pacemakers, multiple cardiac arrests for ICDs, high-risk ventricular pre-excitation for ablation) to ‘preventive’ interventions designed to avoid the risk of serious consequences stemming from the development of severe bradyarrhythmias, ventricular tachyarrhythmias or supraventricular tachyarrhythmias, or related to heart failure. In view of the need to keep clinical practice abreast of the ongoing changes in the potential for care, this evolution has required extensive cooperation between physicians, scientists, engineers, manufacturers, regulatory agencies, and health care providers. Clearly, the rapidity and extent of change has many important practical implications, related to themes such as emerging clinical skills, the complexity of current technology, treatment costs, the need for consensus guidelines, re-organization of care delivery, and the potential of telemedicine. In this supplement we have collected some of the most prominent issues in the field today in the context of lessons learnt in these 50 years of co-operative engagement. We have chosen to spotlight topical issues within the broad spectrum of electrical therapies for the heart: antibradycardia pacing (current and new indications, sensors, autocapture, alternative sites of pacing, etc.); sudden death prevention (risk stratification, current use of ICDs, and barriers to implementation of current guidelines); cardiac resyncronization therapy for heart failure (patient selection, haemodynamic and clinical effects); arrhythmia ablation (indications and technical advances); atrial fibrillation management in the real world, and ablation therapy for atrial fibrillation (mapping and ablation techniques).

2007 - Electromechanical effects of cardiac resynchronization therapy during rest and stress in patients with heart failure. [Articolo su rivista]
Valzania, C; Gadler, F; Eriksson, Mj; Olsson, A; Boriani, Giuseppe; Braunschweig, F.
abstract

Haemodynamic and functional effects of cardiac resynchronization therapy (CRT) have been studied mostly at rest. CRT effects on left ventricular (LV) dyssynchrony and function during stress have not been evaluated in detail.

2007 - Electrophysiologic manifestations of ventricular tachyarrhythmias provoking appropriate defibrillator interventions in high-risk patients with hypertrophic cardiomyopathy. [Articolo su rivista]
Cha, Ym; Gersh, Bj; Maron, Bj; Boriani, Giuseppe; Spirito, P; Hodge, Do; Weivoda, Pl; Trusty, Jm; Friedman, Pa; Hammill, Sc; Rea, Rf; Shen, W. K.
abstract

Our objective was to determine features of ventricular tachyarrhythmias triggering appropriate implantable cardioverter-defibrillator (ICD) interventions in hypertrophic cardiomyopathy (HCM).

2007 - Evaluation of trial-based eligibility for device therapy in the real world: extent of the overlap between trial generated profiles and associated patients outcomes at 1 year. Poster European Congress of Cardiology 2007 [Articolo su rivista]
Boriani, Giuseppe; I., Diemberger; C., Rapezzi; G., Gorini; L., Gonzini; D., Lucci; G. F., Sinagra; G., DI PASQUALE; L., Tavazzi; A. P., Maggioni
abstract

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2007 - Evolution of pacing for bradycardia: Autocapture [Articolo su rivista]
Biffi, M; Sperzel, J; Martignani, C; Branzi, A; Boriani, Giuseppe
abstract

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2007 - How, why, and when may atrial defibrillation find a specific role in implantable devices? A clinical viewpoint. [Articolo su rivista]
Boriani, Giuseppe; Diemberger, I; Biffi, M; Martignani, C; Ziacchi, M; Bertini, M; Valzania, C; Bronzetti, G; Rapezzi, C; Branzi, A.
abstract

This viewpoint article discusses the potential for incorporation of atrial defibrillation capabilities in modern multi-chamber devices. In the late 1990s, the possibility of using shock-only therapy to treat selected patients with recurrent atrial fibrillation (AF) was explored in the context of the stand-alone atrial defibrillator. The failure of this strategy can be attributed to the technical limitations of the stand-alone device, low tolerance of atrial shocks, difficulties in patient selection, a lack of predictive knowledge about the evolution of AF, and, last but not least, commercial considerations. An open question is how atrial defibrillation capability may now assume a specific new role in devices implanted for sudden death prevention or cardiac resynchronization. For patients who already have indications for implantable devices, device-based atrial defibrillation appears attractive as a "backup" option for managing AF when preventive pharmacological/electrical measures fail. This and several other personalized hybrid therapeutic approaches await exploration, though assessment of their efficacy is methodologically challenging. Achievement of acceptance by patients is an essential premise for any updated atrial defibrillation strategy. Strategies that are being investigated to improve patient tolerance include waveform shaping, pharmacologic modulation of pain, and patient-activated defibrillation (patients might also perceive the problem of discomfort somewhat differently in the context of a backup therapy). The economic impact of implementing atrial defibrillation features in available devices is progressively decreasing, and financial feasibility need not be a major issue. Future studies should examine clinically relevant outcomes and not be limited (as occurred with stand-alone defibrillators) to technical or other soft endpoints.

2007 - Implantable cardioverter defibrillators: From evidence of trials to clinical practice [Articolo su rivista]
Boriani, G.; Ricci, R.; Toselli, T.; Ferrari, R.; Branzi, A.; Santini, M.
abstract

A series of landmark randomized trials has validated the role of implantable cardioverter defibrillators (ICDs) not only in the setting of secondary prevention of sudden cardiac death (SCD) but also in the challenging subset of primary prevention of SCD, i.e. for high-risk patients without previous malignant ventricular tachyarrhythmias. Despite definite indications provided by consensus guidelines, the use of ICDs in clinical practice still encounters a series of barriers mainly related to the characteristics of such treatment (a 'rescue' treatment) and its up-front cost, resulting in substantial under-referral and rationing. Cost is likely to remain a major determinant of full acceptance, and implementation of ICD therapy and the problem of how broadened evidence-based indications for implantation can be translated into routine clinical practice require an analysis of available economic resources and identification of priorities for health care. Economic analysis (cost-effectiveness, cost-utility and cost-benefit estimates) provides the most appropriate tool for weighing ICD costs against likely eventual outcome benefits. A series of data indicate that the use of ICDs in appropriately selected high-risk SCD patients is associated with cost-effectiveness ratios similar to, or better than, other accepted treatments, such as renal dialysis. Improvement in risk stratification for SCD and assessment of the cost-effectiveness profile of ICD treatment in specific subgroups of patients appears to be a crucial step in any attempt to maximize health outcomes in a context of limited economic resources.

2007 - Implantable cardioverter-defibrillators and prevention of sudden cardiac death in hypertrophic cardiomyopathy. [Articolo su rivista]
Maron, Bj; Spirito, P; Shen, Wk; Haas, Ts; Formisano, F; Link, Ms; Epstein, Ae; Almquist, Ak; Daubert, Jp; Lawrenz, T; Boriani, Giuseppe; Estes NA, 3rd; Favale, S; Piccininno, M; Winters, Sl; Santini, M; Betocchi, S; Arribas, F; Sherrid, Mv; Buja, G; Semsarian, C; Bruzzi, P.
abstract

Recently, the implantable cardioverter-defibrillator (ICD) has been promoted for prevention of sudden death in hypertrophic cardiomyopathy (HCM). However, the effectiveness and appropriate selection of patients for this therapy is incompletely resolved.

2007 - Implementation of MADIT II in "real world" clinical practice: data from a multicenter international registry.. Abstract European Congress of Cardiology 2007 [Articolo su rivista]
Boriani, Giuseppe; B., Shmidt; M. LUNATI G., Botto; A., Proclemer; A., Erdogan; W., Rahue; M., Russo; M., Santini
abstract

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2007 - Left ventricular pacing by automatic capture verification. [Articolo su rivista]
Biffi, M; Bertini, M; Ziacchi, M; Boriani, Giuseppe
abstract

To investigate the feasibility of transvenous left ventricular (LV) pacing by autocapture at long term. A reliable measurement of LV evoked response (ER) is the pivotal requirement for beat-to-beat detection of ventricular capture and automatic output adjustment.

2007 - Longevity of ICDs: are they all comparable? Abstract XIII World Congress on Cardiac Pacing and Electrophysiology [Articolo su rivista]
M., Biffi; M., Ziacchi; M., Bertini; D., Saporito; C., Martignani; C., Valzania; I., Diemberger; G., Biavati; C., Moschini; Boriani, Giuseppe
abstract

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2007 - Outcome of cardioverter-defibrillator implant in patients with arrhythmogenic right ventricular cardiomyopathy. [Articolo su rivista]
Boriani, Giuseppe; P., Artale; M., Biffi; C., Martignani; L., Frabetti; C., Valzania; I., Diemberger; M., Ziacchi; M., Bertini; C., Rapezzi; M., Parlapiano; A., Branzi
abstract

The aim of the present study was to investigate outcomes of implantable cardioverter-defibrillator (ICD) treatment in patients with arrhythmogenic right ventricular cardiomyopathy (ARVC). We reviewed baseline/follow-up data of 15 consecutive ARVC patients (mean age 55 +/- 15 years) and 30 randomly drawn patients with coronary artery disease (CAD) (mean age 60 +/- 10 years) with matching durations of follow-up (all implanted with ICDs for primary/secondary prevention of sudden death). At implant, appropriate placement of the RV lead was more difficult in ARVC patients. During follow-up (median 41 months), appropriate interventions for any ventricular tachyarrhythmias occurred in 8 (53%) ARVC patients and 17 (57%) CAD patients, but the occurrence of high rate (>240 beats/min) ventricular tachyarrhythmias was higher in ARVC patients. Inappropriate ICD interventions occurred in 5 (33%) ARVC patients and 10 (33%) CAD patients. Lead-related adverse events requiring surgical revision occurred in 7 (47%) ARVC patients as compared with 4 (13%) CAD patients (P = 0.0004). While ICD implantation is highly effective for prevention of sudden death in ARVC, it does carry elevated burdens of long-term lead-related adverse events. These findings underline the need of careful follow-up in ARVC aimed at early recognition of complications that can impair ICD function.

2007 - Painless shock therapy: more than just an attempt to square the circle? [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Martignani, C.
abstract

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2007 - Persistent atrial fibrillation worsen heart rate variabilità, activity and heart rate, as shown by a continuous minitoring by implantable biventricular pacemakers in heart failure patients. Poster Heart Rhythm 2007, 28th Annual Scientific Session of the Heart Rhythm Society [Articolo su rivista]
Padeletti, L; Pugliei, A; Gasparini, M; Lunati, M; Sassara, M; Lanolina, M; Orazi, S; Botto, Gl; Boriani, Giuseppe; Coltella, A; Valsecchi, S; Piro, F.
abstract

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2007 - Plateau waveform shape allows a much higher patient shock energy tolerance in AF patients. [Articolo su rivista]
Boriani, Giuseppe; Edvardsson, N; Biffi, M; Silvestri, P; Martignani, C; Valzania, C; Diemberger, I; Moulder, Jc; Mouchawar, G; Poci, D; Branzi, A; Kroll, M. W.
abstract

Reduced Pain Plateau Waveform. Objectives: To evaluate the possible pain reduction of the plateau waveform in atrial fibrillation (AF) patients. Background: Previous studies have indicated that reduced amplitude waveforms would be less painful than a conventional (65/65% tilt) biphasic waveform. Computer modeling suggested that a moderately long (10-12 msec) plateau (flat topped) shock waveform would deliver equivalent effectiveness with the lowest possible peak amplitude. Methods: We enrolled 27 patients at two sites with persistent AF with a total of 220 shocks delivered during internal atrial cardioversion using an interleaved crossover design. Patient response was scored in three ways: (1) a verbally reported discomfort score, (2) visual analog scale (VAS), and (3) a blinded observer reporting a contraction score. Results: All scores were significantly reduced (P < 0.0001) by the plateau waveform with impressive statistics: Verbal discomfort (3.51 ± 0.13 to 2.89 ± 0.12), VAS (7.00 ± 0.56 to 5.91 ± 0.36), and contraction scores (1.94 ± 0.12 to 1.62 ± 0.12). The average pain threshold shift (TS) for the Verbal score was 2.34, while that for the VAS score was 2.30. (This means that the patient typically could tolerate 2.34 times as much energy with the plateau waveform for the same level of verbally reported discomfort.) The contraction TS was less at 1.57. Response scores were also corrected for the shock sequence number to control for the sensitization effect from multiple shocks. This increased the TS for the Verbal score to 3.58, but the shock number was not significant for the VAS. A pulmonary artery electrode return was associated with lower pain compared with a coronary sinus position. Conclusion: A plateau shaped biphasic waveform resulted in significantly increased shock energy pain tolerances. Controlling for session sensitization, patients tolerated over three times as much energy for the same verbally reported discomfort score

2007 - Potential of medical treatment, device therapy, and conventional surgery in patients referred for heart transplantation. [Articolo su rivista]
Grigioni, F; Potena, L; Russo, A.; Boriani, Giuseppe; Masetti, M; Magnani, G; Coccolo, F; Fallani, F; Branzi, A.
abstract

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2007 - Potential of non-antiarrhythmic drugs to provide an innovative upstream approach to the pharmacological prevention of sudden cardiac death [Articolo su rivista]
Boriani, Giuseppe; Valzania, C; Diemberger, I; Biffi, M; Martignani, C; Bertini, M; Ziacchi, M; Domenichini, G; Saporito, D; Rapezzi, C; Branzi, A.
abstract

Sudden cardiac death (SCD) is the most common cause of death and often occurs in low-risk patients. Present prevention strategies, mainly confined to high-risk subjects (proposed implantable cardioverter defibrillators recipients), have a limited effect on SCD burden in the general population. A relatively unexplored strategy for extending SCD prevention could imply targeting the early (upstream) processes of the complex cascade leading to SCD by non-antiarrhythmic drugs (i.e., beta-blockers, aldosterone antagonists, angiotensin-converting enzyme inhibitors, angiotensin receptor-blocker agents, statins and omega-3 fatty acids). In this innovative pharmacological perspective, agents with upstream effects may also be used in high-risk patients in association with a strictly downstream intervention, such as the implantable cardioverter defibrillator, in an attempt to obtain an additive/synergetic effect.

2007 - Preventing atrial fibrillation in hypertensive patients: the clinical relevance of evidence-based treatment with losartan [Articolo su rivista]
Boriani, Giuseppe; Cervi, E; Biffi, M; Martignani, C.
abstract

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2007 - Rate control in patients with pacemaker affected by brady-tachy form of sick sinus syndrome. [Articolo su rivista]
Boriani, Giuseppe; Padeletti, L; Santini, M; Gulizia, M; Orazi, S; Botto, G; Capucci, A; Biffi, M; Martignani, C; Ricci, R; Vimercati, M; Distefano, P; Grammatico, A.
abstract

In sinus node disease (SND) atrial tachyarrhythmias (ATs) may frequently occur, after implant of a pacemaker for bradycardia, and are to be managed by rate or rhythm control.

2007 - Reverse remodeling after cardiac resynchronization therapy diminishes the need for ICD therapy: the InSync ICD Italian Registry. Abstract European Congress of Cardiology 2007 [Articolo su rivista]
M., Santini; L., Padeletti; M., Landolinai; M., Gasparini; M., Lunati; Boriani, Giuseppe; S., Bianchi; G. B., Perego; A., Denaroi; S., Valsecchi
abstract

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2007 - Temporal Variability of Atrial Fibrillation in Pacemaker Recipients for Bradycardia: Implications for Crossover Designed Trials, Study Sample Size, and Identification of Responder Patients by Means of Arrhythmia Burden. [Articolo su rivista]
Botto, Gl; Santini, M; Padeletti, L; Boriani, Giuseppe; Luzzi, G; Zolezzi, F; Orazi, S; Proclemer, A; Chiaranda, G; Favale, S; Solimene, F; Luzi, M; Vimercati, M; Desanto, T; Grammatico, A.
abstract

Most clinical trials that have tested pacing therapies to prevent and treat atrial tachyarrhythmias (AT) have chosen endpoints such as AT frequency or burden (defined as percentage of time a patient is in AT), but failed to show unequivocal evidence of a clinical impact.

2007 - The occurrence of atrial arrhythmias is not directly related to ventricular pacing. Abstract Europace 2007 [Articolo su rivista]
B., Huegl; A., Gillis; Boriani, Giuseppe; C., Israel; F., Biedermann; B., Gerritse; J. C., Geller; H., Puererfellner
abstract

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2007 - The pharmacologic approach to patients at risk of sudden cardiac death: not only antiarrhythmic drugs [Capitolo/Saggio]
Boriani, Giuseppe; C., Valzania; M., Biffi; C., Martignani; I., Diemberger; M., Bertini; M., Ziacchi; G., Domenichini; C., Rapezzi; A., Branzi
abstract

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2007 - Transvenous cardioverter-defibrillator implantation in a patient with tricuspid mechanical prosthesis. [Articolo su rivista]
Biffi, M; Bertini, M; Ziacchi, M; Boriani, Giuseppe
abstract

Background. A 64-year-old woman was referred to our center because of poorly tolerated ventricular tachycardia (VT) at 210 bpm due to an old myocardial infarction. The patient had been operated on at age of 20 for mitral valve commissurolysis, at age of 49 for ductal carcinoma, at age of 56 for mitral valve replacement, and at age of 61 for tricuspid valve replacement. Left ventricular EF was 31%. The patient was in permanent atrial fibrillation (AF) since the age of 53. She had undergone three cardiac surgery procedures, ending with two prosthetic mechanical valves. The cardiac surgery team advised against an epicardial ICD implantation. Results. We achieved a fully transvenous implant, with a screw-in defibrillation coil in the low right atrium and a bipolar pacing/sensing lead in a posterolateral branch of the coronary sinus. Pacing/sensing parameters were reliable, and effective defibrillation occurred at 20 J by a stepdown protocol. During 16-month follow-up, three VT episodes at 210 bpm were terminated by antitachycardia pacing (ATP) therapy. Left ventricular pacing/sensing was stable at long term. Conclusion. Thanks to technologic improvements, transvenous ICD implantation is feasible and safe in patients with a tricuspid mechanical prosthesis

2007 - Validazione di un algoritmo per la soglia automatica in atrio destro utilizzando due metodi di rilevazione della risposta evocata. Abstract 68° Congresso Nazionale Società Italiana di Cardiologia [Articolo su rivista]
Boriani, Giuseppe; J., Sperzel; C., Kennergren; C., Butter; S., Goetze; A., Garg; B., Schubert; M., Biffi:
abstract

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2007 - Ventricular pacing has no immediate effect on the occurrence of atrial arrhythmias. Abstract Heart Rhythm 2007, 28th Annual Scientific Session of the Heart Rhythm Society [Articolo su rivista]
Hugl, Bj; Gillis, Am; Boriani, Giuseppe; Israel, Cw; Findeisen, Z; Geller, C; Biedermann, F; Gerritse, B; Purerfellner, H.
abstract

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2007 - Wide spectrum of presentation and variable outcomes of isolated left ventricular non-compaction [Articolo su rivista]
Lofiego, C; Biagini, E; Pasquale, F; Ferlito, M; Rocchi, G; Perugini, E; Bacchi Reggiani, L; Boriani, Giuseppe; Leone, O; Caliskan, K; ten Cate, Fj; Picchio, Fm; Branzi, A; Rapezzi, C.
abstract

OBJECTIVES: To investigate diagnostic routes, echocardiographic substrates, outcomes and prognostic factors in patients with isolated ventricular non-compaction (IVNC) identified by echocardiographic laboratories with referral from specialists and primary care physicians. PATIENTS AND DESIGN: Since 1991, all patients with suspected IVNC were flagged and followed up on dedicated databases. Patients were divided into symptom-based and non-symptom-based diagnostic subgroups. RESULTS: 65 eligible patients were followed up for 6-193 months (mean 46 (SD 44). In 53 (82%) patients, IVNC was associated with variable degrees of left ventricular (LV) dilatation and hypokinesia, and in the remaining 12 (18%) LV volumes were normal. Diagnosis was symptom based in 48 (74%) and non-symptom based in 17 (26%) (familial referral in 10). The non-symptom-based subgroup was characterised by younger age, lower prevalence of ECG abnormalities, better systolic function and lower left atrial size, whereas the extent of non-compaction was not different. No major cardiovascular events occurred in the non-symptom-based group, whereas 15 of 48 (31%) symptomatically diagnosed patients experienced cardiovascular death or heart transplantation (p = 0.01, Kaplan-Meier analysis). Independent predictors of cardiovascular death or heart transplantation were New York Heart Association class III-IV, sustained ventricular arrhythmias and left atrial size. CONCLUSIONS: IVNC is associated with a broad spectrum of clinical and pathophysiological findings, and the overall natural history and prognosis may be better than previously thought. Adult patients with incidental or familial discovery of IVNC have an encouraging outlook, whereas those who have symptoms of heart failure, a history of sustained ventricular tachycardia or an enlarged left atrium have an unstable course and more severe prognosis.

2006 - Acute and chronic haemodynamic effects of biventricular pacing and of switching to different pacing modalities in heart failure patients [Articolo su rivista]
Boriani, Giuseppe; Saporito, D; Biffi, M; Martignani, C; Valzania, C; Diemberger, I; Ziacchi, M; Artale, P; Grigioni, F; Bacchi, L; Specchia, S; Rapezzi, C; Branzi, A.
abstract

In patients with severe heart failure, sinus rhythm and wide QRS complex biventricular (BiV) pacing leads to clinical and haemodynamic improvement, but the immediate reversibility of these changes is not known. METHODS: We assessed the acute and medium-term (3-month) haemodynamic effects of BiV pacing and of switching to other pacing modalities in 21 patients with severe heart failure, sinus rhythm and QRS>/=130 ms. Haemodynamic studies were performed: 1) at the time of implantation of a BiV pacing device, during AAI pacing, atrial synchronous right ventricular (RV) pacing, atrial synchronous left ventricular (LV) pacing and atrial synchronous BiV pacing (all at 100 bpm); 2) after 3 months of continuous BiV pacing-with evaluations being made by switching to RV and the other pacing modalities. RESULTS: At both the acute and medium-term evaluations, BiV pacing provided the greatest improvement in cardiac index. Switching from BiV to RV pacing led to a more marked decrease in the cardiac index at 3 months. No strict correlation was evident between acute and medium-term effects of BiV pacing on cardiac index. CONCLUSION: Cardiac resynchronization by BiV pacing provides acute/medium-term improvements in cardiac index. Sudden, medium-term failure of LV stimulation can lead to an even more pronounced haemodynamic derangement than that inducible by RV pacing at baseline. Acute haemodynamic evaluations do not seem to provide a powerful way for identifying medium-term responders.

2006 - Biventricular vs. left univentricular pacing in heart failure: rationale, design, and endpoints of the B-LEFT HF study. [Articolo su rivista]
Leclercq, C; Ansalone, G; Gadler, F; Boriani, Giuseppe; Perez Castellano, N; Grubb, N; Sack, S; Boulogne, E.
abstract

Cardiac resynchronization therapy (CRT) confers sustained therapeutic benefits to patients suffering from congestive heart failure (CHF) due to systolic dysfunction associated with ventricular dyssynchrony. Biventricular (BiV) pacing has, thus far, been the preferred method, as it corrects both electrical and mechanical dyssynchrony. Left ventricular (LV) only pacing, which has conferred similar benefits in pilot studies, may be an alternative treatment method. 'Biventricular vs. left univentricular pacing with ICD back-up in heart failure patients' (B-LEFT HF) is an international, prospective, randomized, parallel-design, double-blind, clinical trial to examine whether LV only pacing is as safe and effective as BiV pacing in patients suffering from CHF. METHODS AND RESULTS: The trial will randomly assign 172 patients to either LV only or BiV pacing. The study has prospectively defined efficacy endpoints to be evaluated at 6 months, which are (i) changes in functional capacity and degree of reverse remodelling (primary) and (ii) changes in the heart failure clinical composite response (secondary). CONCLUSION: Because LV only pacing in CRT is likely to be technically less challenging and costly than BiV, a specifically designed study is needed to compare the safety and effectiveness of the two configurations. B-LEFT HF has been designed to settle this critical issue.

2006 - Characteristics of ventricular tachyarrhythmias occurring in ischemic versus nonischemic patients implanted with a biventricular cardioverter-defibrillator for primary or secondary prevention of sudden death [Articolo su rivista]
Boriani, Giuseppe; Gasparini, M; Lunati, M; Santini, M; Landolina, M; Vincenti, A; Curnis, A; Bocchiardo, M; Padeletti, L; Biffi, M; Allaria, L; Denaro, A; INSYNC ICD ITALIAN REGISTRY, Investigators
abstract

The InSync ICD Registry evaluated patients indicated for cardiac resynchronization therapy with defibrillation.

2006 - Controllo ambulatoriale del portatore di defibrillatore [Capitolo/Saggio]
Biffi, M; Valzania, C; Bertini, M; Ziacchi, M; Saporito, D; Artale, P; Diemberger, I; Martignani, C; Boriani, Giuseppe; Frabetti, L; Branzi, A.
abstract

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2006 - Cost-effectiveness of implantable cardioverter-defibrillators [Capitolo/Saggio]
Boriani, Giuseppe; G., Larsen
abstract

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2006 - Design and rationale of a randomized study to compare amiodarone and Class IC anti-arrhythmic drugs in terms of atrial fibrillation treatment efficacy in patients paced for sinus node disease: The PITAGORA trial [Articolo su rivista]
Gulizia, Michele; Mangiameli, Salvatore; Chiarandà, Giacomo; Spadola, Vincenzo; Di Giovanni, Nicolò; Colletti, Andrea; Bulla, Vincenzo; Circo, Antonio; Pensabene, Orazio; Vasquez, Ludovico; Vaccaro, Ignazio; Grammatico, Andrea; Boriani, G.; Biffi, M.; Orsola, S.; Bramanti, O.; Arrigo, Null; Butera, G.; Miranda, Null; Muscio, G. F.; Tosto, Null; Emanuele, V.; Guzzo, V.; Abele Aiello, Null; Evola, R.; Galvagna, G.; Vincenzo, S.; Ferrante, R.; Arestia, Null; Paternò-Arezzo, Null; Gambino, P.; Fratelli Parlapiano, Null; Giglia, S.; Elia, S.; Grassi, R.; Busà, G.; Papardo, Null; Gulizia, M.; Francese, G. M.; Luigi, S.; Currò, S.; Indelicato, V.; Lisi, F.; Coppola, A.; Cannizzaro, Null; Malluzzo, Null; Costanza, Null; Barone Lombardo, Null; Mangiameli, S.; Doria, Null; Garibaldi, Null; Mossuti, E.; Maltese, Null; Umberto, I.; Orazi, S.; Pavia, L.; Piemonte, Null; Puntrello, C.; Di Girolamo, Null; Antonio Abate, S.; Santini, M.; Ricci, R.; Filippo Neri, S.; Spadola, V.; Piccione, Null; Catalano, C.; Giovanni di Dio, S.; Vanaria, Null; Scalisi, Null; Tomaselli, Null; Vasco, C.; Battaglia, Null; Umberto, I.
abstract

Aims: Many sinus node disease (SND) patients suffer from atrial fibrillation (AF). Anti-arrhythmic drugs (AADs) are the therapeutic mainstay for AF prophylaxis. The PITAGORA trial has a multicentre, prospective, randomized, single blind design to compare amiodarone with Class IC AADs in patients who have an AF history and are paced for SND. Methods and results: Starting from January 2001, 176 patients received a Medtronic AT500 pacemaker. AADs were randomly assigned with a 3:2 ratio between Class III and Class IC. Randomization was stratified in order to assign two patients to amiodarone and one patient to sotalol every three Class III AAD patients. After a 5-month observational period, Ramp or Burst+ ATP therapies were enabled in a randomized way, maintained for 4 months, and then crossed over. Total follow-up period is 21 months. The primary long-term objective is to show the non-inferiority of IC AADs compared with amiodarone in terms of time to first occurrence of a composite endpoint (death, atrial cardioversion, hospitalizations due to AF or heart failure, or change of AADs). Data will be analysed on an intention-to-treat basis. The primary short-term objective is to compare Ramp vs. Burst+ efficacy in terminating atrial tachyarrhythmias treated by the device. Secondary endpoints are major clinical events, medication toxicity, symptoms, AF burden, and quality-of-life. Conclusion: Given the high morbidity and healthcare costs associated with AF, new therapeutic strategies are needed. The results of the PITAGORA trial may help in guiding AADs therapy and ATP programming in SND patients suffering from AF. © 2006 Oxford University Press.

2006 - Electrocardiographic remodeling during cardiac resynchronization therapy [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Martignani, C; Ziacchi, M; Saporito, D; Grigioni, F; Domenichini, G; Valzania, C; Diemberger, I; Bertini, M; Specchia, S; Branzi, A.
abstract

More information is required on the relationship between electrical and structural reverse remodeling in patients treated with cardiac resynchronization theraphy. METHODS: QRS and JT intervals were investigated during different pacing modes before and 3 months after implantation of a device for biventricular (BiV) pacing in 20 patients with severe drug-refractory heart failure (with left ventricular ejection fraction < 40% and QRS > 120 ms); structural remodeling was evaluated by echocardiography. RESULTS: QRS interval was significantly shortened by BiV pacing both acutely (p=0.002) and at 3 months (p=0.007). No significant change was found in the JT interval. The extent of QRS shortening obtained by BiV pacing showed moderate correlations with the reduction of end-systolic and end-diastolic volumes (r=0.53, p=0.016 and r=0.45, p=0.045, respectively) as well as with increase of left ventricular ejection fraction (r=0.49, p=0.028) at 3 months. The widening of QRS observed during right ventricular (RV) pacing was greater after 3 months of BiV pacing (with respect to acute assessments), suggesting accentuation of pacing-induced electrical dyssynchrony after a period of pacing-induced resynchronization. CONCLUSION: The extent of QRS shortening induced by BiV pacing appears to correlate with the reverse structural remodeling (in terms of reduction in end-systolic volume). The acute changes and the remodeling process occurring at mid-term in the overall population of CRT-treated patients do not appear to involve the JT interval. A period of pacing-induced resynchronization appears to accentuate the potential for RV pacing-driven electrical

2006 - I problemi aritmologici nello scompenso cardiaco [Capitolo/Saggio]
Boriani, Giuseppe; L., Frabetti; M., Biffi; C., Martignani; I., Diemberger; A., Branzi
abstract

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2006 - Il ruolo della cardiostimolazione nella terapia dello scompenso cardiaco [Capitolo/Saggio]
Boriani, Giuseppe; M., Biffi; C., Martignani; M., Bertini; C., Valzania; A., Branzi
abstract

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2006 - Il trattamento profilattico delle recidive di fibrillazione atriale. 1. Il trattamento farmacologico [Capitolo/Saggio]
A., Capucci; Boriani, Giuseppe
abstract

N/A

2006 - Monitored atrial fibrillation duration predicts arterial embolic events in patients suffering from bradycardia and atrial fibrillation implanted with antitachycardia pacemakers. [Articolo su rivista]
Capucci, A; Santini, M; Padeletti, L; Gulizia, M; Botto, G; Boriani, Giuseppe; Ricci, R; Favale, S; Zolezzi, F; Di Belardino, N; Molon, G; Drago, F; Villani, Gq; Mazzini, E; Vimercati, M; Grammatico, A.
abstract

The aim of our study was to evaluate arterial embolism (AE) occurrence rates and predictors in patients suffering from bradycardia and wearing a pacemaker with antitachycardia pacing therapies. BACKGROUND: Atrialfibrillation (AF) is associated with a high incidence of AE. METHODS: A total of725 patients (360 men, age 71 +/- 11 years) were implanted with a DDDRP pacemaker (Medtronic AT500, Medtronic Inc., Minneapolis, Minnesota). At baseline 225 (31.0%) patients received antiplatelet therapy and 264 (36.4%) patients received anticoagulation agents. RESULTS: Over a median 22-month follow-up (25th to 75th interquartile range 16 to 30 months), AE occurred in 14 (1.9%) patients: 7 patients suffered a nonfatal ischemic stroke (0.6% per year), 4 patients had transient ischemic attack (0.34% per year), and 3 patients had embolic complications. Among baseline patients' characteristics, multivariate logistic analysis showed that embolic events are independently associated to ischemic heart disease (7.0 odds ratio [OR], 95% confidence interval [CI] 2.3 to 21.3, p = 0.001), prior embolic event (7.3 OR, 95% CI 1.2 to 43.9, p = 0.029), diabetes (5.0 OR, 95% CI 1.2 to 15.7, p = 0.032), and hypertension (4.1 OR, 95% CI 1.1 to 15.6, p = 0.036). The risk of embolism, adjusted for known risk factors, was 3.1 times increased (95% CI 1.1 to 10.5, p = 0.044) in patients with device-detected atrial fibrillation episodes longer than one day during follow-up. CONCLUSIONS: In a cohort of patients with bradycardia and AF, arterial embolism was common in patients with ischemic cardiopathy, hypertension, diabetes mellitus, and in patients with known stroke risk factors. Atrial fibrillation occurrences longer than one day were independently associated with embolic events.

2006 - Neurohormones and inflammatory mediators in patients with heart failure undergoing cardiac resynchronization therapy: Time courses and prediction of response. [Articolo su rivista]
Boriani, Giuseppe; Regoli, F; Saporito, D; Martignani, C; Toselli, T; Biffi, M; Francolini, G; Diemberger, I; Bacchi, L; Rapezzi, C; Ferrari, R; Branzi, A.
abstract

Despite interest in neurohormonal activation as a determinant of prognosis in chronic heart failure (CHF) and as a target for pharmacological treatments, data are lacking on the time-related effects of electrical cardiac resynchronization therapy (CRT) on a broad spectrum of neurohormones and cytokines. The aim of this study was to assess time-courses and extents of changes within the neurohormonal profile of CHF patients treated with CRT. We performed a prospective follow-up study in 32 patients with NYHA class III-IV CHF to investigate the effects of CRT on a broad panel of neurohormones proposed for characterization of CHF patients. Levels of atrial and brain natriuretic peptides (ANP, BNP), epinephrine, norepinephrine, aldosterone, plasma renin activity, IL-6, TNF, soluble receptors sTNFR1 and 2, and chromogranin A were assessed before implantation and after 3 months of CRT; when feasible, measurements were also performed at 1 week, 1 month and 12 months (clinical evaluation, echocardiography and ECG were also performed at each time-point). The results showed that at 3 months improvement in NYHA class and echographically assessed left ventricular (LV) reverse structural remodeling were accompanied by significant reductions versus baseline in ANP and BNP, but not in other neurohormones. Moreover a baseline ANP concentration

2006 - Optimization of pacing algorithms to prevent and treat supraventricular tachyarrhythmias [Articolo su rivista]
Ricci, Rp; Boriani, Giuseppe; Grammatico, A; Santini, M.
abstract

Preventive atrial pacing and antitachycardia pacing have been proposed for the treatment of atrial fibrillation and associated arrhythmias in patients with indications for device implantation. Preventive algorithms provide overdrive atrial pacing, reduction of atrial premature beats, and prevent short-long atrial cycles with good patient tolerance. However, clinical trials testing preventive algorithms have shown contradictory results, possibly because of different trial designs, end points and patient populations. Factors probably responsible for neutral results include an already high atrial pacing percentage with the conventional DDDR mode, suboptimal atrial pacing site, and the deleterious effects of high percentages of right ventricular apical pacing. Atrial antitachycardia pacing therapies are effective in treating organized atrial tachyarrhythmias (that precede atrial fibrillation), mainly when delivered early after the onset particularly if the tachycardia is relatively slow. Antitachycardia pacing therapies might influence atrial fibrillation burden, but clinical studies have shown conflicting results about this issue. Consistent monitoring of atrial and ventricular rhythm including progression to persistent forms of atrial arrhythmias, variability of atrial arrhythmia recurrence patterns and onset mechanisms as well as antitachycardia pacing efficacy should be recorded in the stored device memory and used for optimal individual programming of these new functions.

2006 - Primary Prevention of Sudden Cardiac Death: Can We Afford the Cost of Cardioverter-Defibrillators? Data from the Search-MI Registry-Italian Sub-study [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Russo, M; Lunati, M; Botto, G; Proclemer, A; Vergara, G; Rahue, W; Martignani, C; Ricci, R; Santini, M.
abstract

Large randomized trials show that in appropriately selected patients with left ventricular dysfunction, implantable cardioverter-defibrillators (ICDs) can improve overall survival at 2-5 years. Since direct implementation of the criteria used in the MADIT II and SCD-HeFT will lead to a marked rise in ICD implants, there is a growing fear that increased use of ICDs may cause a dramatic burden to health care systems. The ICD has traditionally been seen as an expensive form of treatment, which is difficult to accept at the first look. This is mainly due to the nonlinear character of the ICD investment, characterized by high initial expenditure, followed by a deferred pay-off in terms of clinical benefits. Cost-effectiveness analysis may help provide a different perspective on the problem of ICD cost, as may estimation of the daily cost of ICD treatment, assuming a time horizon of 5-7 years--a particularly interesting subject for further registry studies.

2006 - Randomized comparison between Ramp and Burst+ atrial antitachycardia pacing therapies in patients suffering from sinus node disease and atrial fibrillation and implanted with a DDDRP device. [Articolo su rivista]
Gulizia, M; Mangiameli, S; Orazi, S; Chiaranda, G; Boriani, Giuseppe; Piccione, G; Digiovanni, N; Colletti, A; Puntrello, C; Butera, G; Vasco, C; Vaccaro, I; Scardace, G; Grammatico, A.
abstract

Atrial tachycardia and flutter frequently occur in association with atrial fibrillation and may be treated by overdrive pacing in patients who receive pacemakers with antitachycardia pacing (ATP) capabilities. The PITAGORA trial was a multi-centre, randomized, cross-over study aimed at comparing two different ATP modes for atrial tachyarrhythmia (AT) termination in patients suffering from sinus node disease (SND). METHODS AND RESULTS: One hundred and seventy-six patients (72 M, age 71+/-9 years) received a Medtronic AT500 pacemaker. All patients were on class IC or III antiarrhythmic drugs. After a 5-month observation period, 170 patients were randomized to either Ramp or Burst+ ATP therapy; 4 months later they crossed over. One hundred and fifty-seven patients completed the 13 months of follow-up; 114 (72.6%) suffered 6088 AT episodes. In 75 patients, 1904 AT episodes were treated and 934 (49.1%) successfully terminated. The median value of individual patients' ATP efficacy was 60%. Burst+ terminated 387 out of 873 AT episodes (44%) in 58 patients. Ramp terminated 547 out of 1031 AT episodes (53%, P<0.001) in 56 patients. Ramp efficacy was significantly (P<0.01) and directly correlated with AT cycle length (ATCL), whereas Burst+ efficacy was not. Ramp showed higher (P<0.001) termination efficacy than Burst+ for ATCL >240 ms. Quality of life, as measured by the EuroQoL questionnaire, and number of symptoms significantly improved in the overall population. This improvement was significantly higher in patients with ATP efficacy >60%. CONCLUSION: In patients suffering from SND and AT, Ramp therapy shows higher termination efficacy than Burst+ therapy in AT episodes with ATCL >240 ms. Further studies are required to show the impact of ATP on clinical outcomes.

2006 - Randomized comparison of simultaneous biventricular stimulation versus optimized interventricular delay in cardiac resynchronization therapy The Resynchronization for the HemodYnamic Treatment for Heart Failure Management II implantable cardioverter defibrillator (RHYTHM II ICD) study [Articolo su rivista]
Boriani, Giuseppe; Muller, Cp; Seidl, Kh; Grove, R; Vogt, J; Danschel, W; Schuchert, A; Djiane, P; Biffi, M; Becker, T; Bailleul, C; Trappe, Hj
abstract

The clinical value of interventricular (V-V) delay optimization in patients with chronic congestive heart failure (CHF) undergoing implantation of a device for cardiac resynchronization therapy (CRT) has not been clearly demonstrated. METHODS: RHYTHM II was a single-blind randomized trial including 121 recipients of a device for CRT with cardioverter/defibrillator capabilities (CRT-D) randomly assigned in a 1:3 ratio to simultaneous (n = 30) versus optimized (OPT) (n = 91) biventricular pacing. V-V delay was optimized by echocardiography. The study end points were (1) freedom from CRT-D system-related complications and (2) changes between preimplant and 6 months of follow-up in (a) New York Heart Association CHF functional class, (b) distance covered during a 6-minute hall walk, and (c) quality of life (QOL). RESULTS: In the OPT group, the V-V delay ranged from 0 to 80 milliseconds, with 28.4% of patients stimulated at an OPT V-V delay of 0 milliseconds. The overall 6-month survival free of adverse events requiring invasive interventions was 81.8%. In the whole cohort, 6 months of CRT-D was associated with a significant decrease in New York Heart Association class, increase in the distance covered during the 6-minute hall walk, and improvement in QOL (each P < .0001). The effects of CRT-D on these end points were similar in both study groups. CONCLUSIONS: Cardioverter-defibrillator capabilities was associated with a significant alleviation of CHF symptoms, increase in functional capacity, and improvement in QOL. The optimization of the V-V delay conferred no additional benefit compared with simultaneous biventricular stimulation.

2006 - Reducing unnecessary right ventricular pacing with the managed ventricular pacing mode in patients with sinus node disease and AV block. [Articolo su rivista]
Gillis, Am; Purerfellner, H; Israel, Cw; Sunthorn, H; Kacet, S; Anelli Monti, M; Tang, F; Young, M; Boriani, Giuseppe
abstract

Frequent and unnecessary right ventricular apical pacing increases the risk of atrial fibrillation or congestive heart failure. We evaluated a new pacing algorithm, managed ventricular pacing (MVP) which automatically changes modes between AAI/R and DDD/R in patients receiving pacemakers for symptomatic bradycardia. METHODS: Patients were randomized to the MVP mode or DDD/R mode for 1 month and then crossed over to the alternate pacing modality for an additional month. On completion of the crossover phase, the pacing mode selected was individualized and patients were followed for an additional 4 months. RESULTS: Of the 129 patients who successfully completed the crossover study, the cumulative percent ventricular pacing was significantly reduced in the MVP mode (median 1.4%) compared to the DDD/R mode (median 89.6%, 94.0% relative reduction; 95% CI 89.3-98.8%, P < 0.001). Patients with sinus node disease (SND, n = 51) when compared to patients with AV block (AVB) (n = 68) experienced a greater reduction in ventricular pacing with the MVP mode compared to the DDD/R mode (median relative reduction 99.1%; 95% CI 97.5-99.9% vs median relative reduction 60.1%; 95% CI 16.7-93.9% P < 0.001). The reduced percent ventricular pacing during MVP was sustained over longer term follow-up. CONCLUSIONS: The majority of patients with a bradycardia indication for cardiac pacing do not require ventricular pacing most of the time. The MVP mode significantly reduces unnecessary right ventricular pacing. This mode benefits even patients with intermittent AVB and is sustained over longer term follow-up

2006 - Relevance of cardioverter defibrillators for the prevention of sudden cardiac death on the timing of heart transplantation. [Articolo su rivista]
Grigioni, F; Boriani, Giuseppe; Barbieri, A; Russo, A; Reggianini, L; Bursi, F; Potena, L; Ricci, C; Fallani, F; Coccolo, F; Magnani, G; Magelli, C; Modena, Maria Grazia; Branzi, A.
abstract

Information on the incidence of decompensation of chronic heart failure (CHF) in heart transplantation (HT) candidates eligible for prophylactic implantable cardioverter defibrillators (ICD) could provide insights into the influence of ICD on the timing for HT.

2006 - Role of severe functional mitral regurgitation in predicting electrical remodeling in idiopathic dilated cardiomyopathy. [Articolo su rivista]
Barbieri, A; Grigioni, F; Bursi, F; Reggianini, L; Bonatti, S; Ricci, C; Boriani, Giuseppe; Russo, A; Magelli, C; Branzi, A; Modena, Maria Grazia
abstract

OBJECTIVE: To investigate incidence and predictors of clinically relevant QRS widening (predefined as >/= 10% with respect to baseline) in idiopathic dilated cardiomyopathy (IDC) and particularly the prognostic role of functional mitral regurgitation (MR). Although QRS widening in left ventricular systolic dysfunction carries relevant prognostic and therapeutic implications, its incidence and predictors in patients with IDC remain unknown. METHODS: We analyzed 114 patients with IDC receiving optimized medical treatment (age 52 +/- 10 years; 44% males; 36% New York Heart Association class III-IV) who underwent clinical, echocardiographic, hemodynamic, and laboratory evaluations and at least two electrocardiograms >/= 6 months after the index evaluation. RESULTS: During follow-up (median 20 months), 19 (17%) patients developed clinically relevant QRS widening, corresponding to an incidence of 8% per year. At multivariable analysis, the presence of echocardiographically detected severe MR (P = 0.029) and mean right atrial pressure (RAP) by right heart catheterization (P = 0.021) independently predicted clinically relevant QRS widening. CONCLUSIONS: Clinically relevant QRS widening is relatively frequent in IDC despite optimized medical treatment, and is independently predicted by MR severity and high RAP. IDC patients presenting either of these risk-factors might benefit from strict follow-up, which could also allow timely detection of the onset of indications for cardiac resynchronization therapy.

2006 - Role of ventricular Autocapture function in increasing longevity of DDDR pacemakers: a prospective study. [Articolo su rivista]
Boriani, Giuseppe; Rusconi, L; Biffi, M; Pavia, L; Sassara, M; Malfitano, D; Bongiorni, Mg; Padeletti, L; Filice, I; Sanfelici, D; Maffei, P; Vicentini, A; Branzi, A.
abstract

Autocapture is an algorithm for automatic adaptation of ventricular output to capture threshold. The aim of this prospective study was to estimate the effects of ventricular Autocapture algorithm on DDD-DDDR pacemaker longevity. METHODS AND RESULTS: Eighty-three patients implanted with a DDD-DDDR pacemaker (Affinity or Entity; St Jude Medical, USA) were enrolled and the Autocapture function was activated pre-discharge. Ventricular pulse duration was randomly programmed at 0.3 or 0.4 ms, with a cross-over at 8-12 weeks and again at 13-14 months. Diagnostic data were retrieved from device memory and by calculating battery current drain from long-term threshold recordings; device longevity was estimated at the following settings: Autocapture with a pulse duration of 0.3 and 0.4 ms, respectively, standard output (3.5 V, 0.4 ms) and conventional low output programming (2.5 V, 0.4 ms). According to a series of assumptions, Autocapture was associated with a 55-60% increase in estimated device longevity compared with standard output programming and a 6-7% increase in longevity compared with low output programming. No significant differences were found between Autocapture programmed with a pulse duration of 0.3 or 0.4 ms. In projections to a 10-year follow-up, use of the Autocapture function resulted in a 42% reduction in pacing-related estimated costs compared with standard output programming at 3.5 V, 0.4 ms. CONCLUSION: Pacing with constant adaptation of ventricular output in dual-chamber devices has the potential to increase generator longevity and to reduce sizeably pacing-related costs compared with standard programming

2006 - Short QT syndrome and arrhythmogenic cardiac diseases in the young: the challenge of implantable cardioverter-defibrillator therapy for children. [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Valzania, C; Bronzetti, G; Martignani, C.
abstract

not available

2006 - The epidemiological burden of atrial fibrillation: a challenge for clinicians and health care systems. [Articolo su rivista]
Boriani, Giuseppe; Diemberger, I; Martignani, C; Biffi, M; Branzi, A.
abstract

N/A

2005 - A controlled study on the effect of verapamil on atrial tachycaarrhythmias in patients with brady-tachy syndrome implanted with a DDDR pacemaker [Articolo su rivista]
Boriani, Giuseppe; Bertaglia, E; Carboni, A; Latini, R; Biffi, M; Martignani, C; Sciotto, F; Branzi, A.
abstract

While verapamil has been proposed as a treatment for reducing electrophysiological remodeling due to atrial fibrillation and atrial tachyarrhythmias, no previous study has tested its effects in brady-tachy patients implanted with a dual-chamber pacemaker. Fourteen patients with frequent episodes of atrial fibrillation (> or =2 episodes/month) in the setting of brady-tachy syndrome, implanted with a DDDR pacing system with extensive monitor function (Selection 900, Vitatron) were enrolled. Four months after implantation, they were randomly allocated to a 2-month period of treatment with verapamil (240 mg/day) or to no treatment, followed by a crossover. The burden of atrial tachyarrhythmias, the total number of hours spent in atrial tachyarrhythmia and the mean number of hours per day spent in atrial tachyarrhythmia were retrieved from diagnostic devices. The accuracy of atrial tachyarrhythmias detection was confirmed independently by two observers. The main results showed that treatment with verapamil was associated with a trend towards an higher percentage of atrial pacing in comparison with control (mean value+/-S.D.=63.2+/-29.9% vs. 57.3+/-30.6%, median value 53% vs. 49%, P value at Wilcoxon signed rank test=0.069), but without any significant reduction in atrial tachyarrhythmia burden (4.5+/-11.8 vs. 3.3+/-9.1%) or total hours spent in atrial tachyarrhythmia (65+/-161 vs. 48+/-131 h). Palpitation episodes were not significantly reduced by verapamil treatment in comparison with control (10.3+/-7.8 vs. 6.1+/-6.5). In conclusion, verapamil does not exert any beneficial effect on documented episodes of atrial tachyarrhythmia in patients with brady-tachy syndrome implanted with a DDDR device. Moreover, this drug was ineffective in reducing the number of palpitation episodes reported by the patient.

2005 - Atrial fibrillation in patients with a dual defibrillator: Characteristics of spontaneous and induced episodes and effect of ventricular tachyarrhythmia induction [Articolo su rivista]
Boriani, Giuseppe; Raviele, A; Biffi, M; Gasparini, G; Martignani, C; Valzania, C; Diemberger, I; Corrado, A; Raciti, G; Branzi, A.
abstract

The pattern of FF intervals during atrial fibrillation (AF) has been analyzed in induced and spontaneous AF episodes, after the induction of ventricular fibrillation (VF) and after atrial shock, in order to suggest practical considerations for AF management in patients implanted with antitachycardia devices. METHODS: In 13 patients implanted with a dual-chamber defibrillator, FF intervals were analyzed during two separate induced AF episodes, before and after VF induction over AF, as well as during spontaneous AF episodes and after unsuccessful atrial shocks. The following parameters were considered: mean atrial cycle length (CL), atrial CL stability, and standard deviation of the atrial cycle. RESULTS: The AF pattern had comparable characteristics considering two separate inductions of AF, as well as spontaneous AF episodes. Ventricular tachyarrhythmia induction resulted in a shortening of atrial CL (P < 0.02) and in a less organized AF pattern (P < 0.005). Changes in the FF interval after ineffective shock therapy showed a shortening of AF cycles after shocks with energies far below the defibrillation threshold. CONCLUSIONS: (a) The AF pattern is reproducible in separate inductions of sustained AF and in spon taneous episodes, (b) dynamic changes involving a shortening of the AF cycle and an evolution to a less homogeneous pattern occur after VF induction, revealing a complex interplay between AF and VF, and (c) FF interval analysis after ineffective shock delivery may allow the relationship between delivered shock energy and effective defibrillation energy to be estimated, thereby providing practical suggestions for step-up protocols in atrial cardioversion.

2005 - Cardiac resynchronization therapy: effects on left and right ventricular ejection fraction during exercise. [Articolo su rivista]
Boriani, Giuseppe; Fallani, F; Martignani, C; Biffi, M; Saporito, D; Greco, C; Ziacchi, M; Levorato, M; Pontone, G; Valzania, C; Diemberger, I; Franchi, R; Branzi, A.
abstract

In patients with heart failure and wide QRS complex, cardiac resynchronization therapy (CRT) is associated with improvement of symptoms and cardiac function. This study examined the effects of a 3-month period of CRT on left ventricular (LV) and right ventricular (RV) ejection fraction (EF) and on LV volumes, both at rest and during exercise. A CRT system was implanted in 15 patients with severe heart failure and wide QRS. Before implant and 3 months later, all patients underwent assessment of cardiac performance with equilibrium Tc(99) radionuclide angiography with imaging in the best septal left anterior oblique view. Exercise was performed on a bicycle ergometer. At 3 months, a significant improvement in New York Heart Association functional class was observed, and radionuclide angiography showed a significant decrease in LV volumes and a significant increase in LVEF at rest, as well as a significant increase in LVEF during exercise. The remodeling processes associated with CRT did not appear to include RV function, since RVEF did not improve, and changes in RVEF did not correlate with changes in LVEF, neither at rest nor during exercise.

2005 - Comparison of induced and spontaneous atrial tachyarrhythmias in patients with a history of spontaneous atrial tachyarrhythmias [Articolo su rivista]
Wollmann, Cg; Birnie, D; Tang, A; Boriani, Giuseppe; Kuhl, M; Bocker, D.
abstract

This retrospective study investigated whether induced episodes could be used to predict the morphology of future spontaneous atrial episodes. METHODS: Eighty-two patients (64 +/- 12 years; 77% male; CAD in 60%; left ventricular ejection fraction 45 +/- 16%) with a history of atrial tachycardia or atrial fibrillation (AT/AF) were implanted with a dual-chamber implantable cardioverter defibrillator (ICD) and followed for 6 months. A total of 224 episodes of induced and spontaneous AT/AF were classified into type I, II, and III according to the method of Israel et al. and then compared based on average cycle length (CL) and atrial amplitude. Episodes were also grouped as "pace-terminable" or "nonpace-terminable" based on the CL definition of Gillis et al. RESULTS: The analysis of 121 induced episodes (from 80 patients) and 103 spontaneous episodes (from 43 patients) showed that within each arrhythmia type, there were no significant differences in CL or mean amplitude between induced and spontaneous episodes. Additional analysis of patients that had both induced and spontaneous episodes (n = 41) showed 78% had at least one spontaneous episode that matched the induced episode. Fifty-seven percent of spontaneous episodes were considered to be pace-terminable based on CL. CONCLUSIONS: Our data suggest that there is no significant difference between induced and spontaneous episodes of AT/AF of the same type. The majority of patients had at least one spontaneous episode of the same type as the induced episode, showing that induced atrial arrhythmias may be useful in predicting the morphology of future spontaneous episodes and in identifying patients potentially benefiting from atrial antitachycardia pacing.

2005 - Dilated-Hypokinetic evolution of hypertrophic cardiomyopathy [Articolo su rivista]
Biagini, E; Coccolo, F; Ferlito, M; Perugini, E; Rocchi, G; Bacchi Reggiani, L; Lofiego, C; Boriani, Giuseppe; Prandstraller, D; Picchio, Fm; Branzi, A; Rapezzi, C.
abstract

OBJECTIVES: This study sought to investigate the incidence, risk factors, and prognosis of dilated-hypokinetic evolution in a large cohort of patients with hypertrophic cardiomyopathy (HCM) followed up at a cardiology center serving both the pediatric and the adult population. BACKGROUND: The available data on this evolution of HCM mainly regards prevalence (rather than incidence) in adults, with very little being known about the pediatric population. METHODS: A total of 222 consecutive HCM patients (65% men, 19% < or =18 years old) were prospectively evaluated for a mean follow-up of 11 +/- 9 years. RESULTS: A diagnosis of dilated-hypokinetic HCM was made in 12 patients at first evaluation (11 without previous septal myectomy surgery; prevalence, 4.9%). Twelve of the 210 patients with classic HCM at first evaluation underwent dilated-hypokinetic evolution (incidence, 5.3/1,000 patient-years). Patients with prevalent/incident dilated-hypokinetic evolution were younger at first evaluation (32 +/- 14 years vs. 41 +/- 21 years, p = 0.04) and more often had a family history of HCM (61% vs. 26%, p = 0.002) or sudden death (43% vs. 19%, p = 0.01) with respect to patients who maintained classic HCM. Moreover, they showed greater interventricular septum (23 +/- 3 mm vs. 19 +/- 6 mm, p = 0.004) and posterior wall (15 +/- 3 mm vs. 13 +/- 4 mm, p = 0.006) thickness. Cardiovascular death-free survival was lower among patients with dilated-hypokinetic HCM (p < 0.04). Cox proportional hazards regression analysis identified left ventricular wall thickness (hazard ratio [HR] = 1.07; 95% confidence interval [CI], 1.01 to 1.14; p = 0.03) and end-diastolic diameter (HR = 1.08; 95% CI 1.04 to 1.11; p = 0.0001) as independent predictors of cardiovascular death. CONCLUSIONS: Dilated-hypokinetic evolution is rare but not exceptional in HCM. Young age at diagnosis, family history of HCM, and greater wall thickness are incremental risk factors for dilated-hypokinetic HCM, which carries an ominous prognosis.

2005 - Evaluation of fusion beat detection with a new ventricular automatic capture algorithm in ICDs. [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Schwarz, T; Dong, Y; Koenig, A; Temporin, S; Meyer, S; Sperzel, J.
abstract

This study evaluated a newly developed automatic capture verification scheme for implantable cardioverter defibrillators (ICDs) regarding discrimination of capture, fusion, and noncapture beats, with an emphasis on fusion detection. The algorithm uses evoked response detection based on a sensing vector from right ventricular shocking coil to Can. Patients undergoing ICD implant or replacement were enrolled in this study. An external system was used for pacing and data acquisition. To provoke ventricular fusion beats, VVI patients were paced close to the rate of their intrinsic rhythm and DDD patients were paced close at their intrinsic PR interval. Surface ECG and wideband filtered intracardiac electrograms were recorded for off-line analysis. Each paced beat was independently classified visually by surface ECG and by the automatic detection algorithm. The algorithm performance was then evaluated by comparing the classification results. Twenty-seven patients (22 males, 5 females; 63.8 +/- 12.5 years) were analyzed. Device and lead demographics were: 18 DDD/9 VVI; 16 dedicated bipolar, 11 integrated bipolar leads; 18 acute, 9 chronic (3.7 +/- 2.0 years) leads. In total, 2064 beats were analyzed, including 1,477 fusion beats and 587 capture beats. Fusion detection sensitivity and specificity were 99.5% and 99.0%, respectively. Seven true-fusion beats (0.5%) were classified as capture and 6 capture beats (1.0%) were identified as fusions. Capture or fusion beats were never detected as non-capture beats. It is concluded that the algorithm was effective in detecting fusion beats. It could potentially be used in ICD applications that need accurate fusion detection.

2005 - Evaluation of the atrial evoked response for capture detection with high-polarization leads. [Articolo su rivista]
Sperzel, J; Binner, L; Boriani, Giuseppe; Biffi, M; Snell, J; Scheiner, J; Park, E; Bornzin, G.
abstract

AutoCapture based on the evoked response can be confounded by electrode polarization. In this study, polarization was measured in human subjects who had chronic atrial leads. The aim of the study was to determine whether electrode polarization can be measured using a time integral atrial evoked-response integral (AERI) of the negative portion of the atrial paced ER evoked-response signal and to determine whether high-polarization atrial leads unsuitable for AutoCapture can be identified a priori. Atrial intracardiac-electrogram (IEGM) signals from 39 patients with implanted pacemakers were recorded and analyzed. The signals were recorded during conventional atrial-threshold searches. A total of 221 atrial-capture thresholds were recorded, ranging from 0.25 to 2.75 V with a mean of 0.79 V. Each evoked response was evaluated using the AERI in a 36 ms window following the 0.4 ms atrial stimulus. The polarization was estimated as a linear function of stimulus voltage using the evoked-response signal integral of captured beats identified on the IEGM. The 221 threshold-search datasets were obtained using leads with eight different electrode materials. Polarization could be measured using AERI as a function of stimulus voltage. Furthermore, this polarization measure can be used to identify high-polarization leads, which are ill suited for the atrial AutoCapture algorithm.

2005 - Heart failure after myocardial revascularization: Risk markers [Articolo su rivista]
Biffi, M; Bertini, M; Boriani, Giuseppe; Martignani, C; Branzi, A.
abstract

We investigated the prognostic weight of several risk factors for heart failure in patients undergoing CABG. We followed 351 consecutive patients for 18+/-12 months after surgery to assess clinical outcome, presence and degree of heart failure. The risk of developing heart failure >class 2 at 1 year was investigated by logistic regression on the following preoperative variables: sex, age, left ventricular EF, QRS duration, previous MI, history of heart failure, atrial fibrillation (AF), hypertension, hypercholesterolemia, diabetes, previous stroke. Age was 70+/-8 years and EF was 54+/-12% at the time of surgery. Heart failure >class 2 occurred in 95/351 patients (27%) at follow up. Logistic regression identified QRS duration (OR=1.02), a history of stroke (OR=3.94), and diabetes (OR=1.98) as predictors of CHF at follow up. All the other variables were not risk markers for heart failure at logistic regression. Thirty five patients (10%) had QRS>/=140 ms before surgery; 51% of them had CHF at follow up compared to 24% of patients with QRS<140 ms (p<0.05). In the current surgical era, candidates to CABG (50% of patients older than 70 years) have a relevant likelihood of heart failure at follow up, despite myocardial revascularization. Risk stratification may rely upon inexpensive variables as previous stroke, diabetes, and QRS duration. A minority of patients (5%) could benefit from LV-based pacing, which should be considered at the same surgical time via an epicardial implantation.

2005 - Implantable dual-chamber defibrillator for the selective treatment of spontaneous atrial and ventricular arrhythmias: arrhythmia incidence and device performance. [Articolo su rivista]
Schuchert, A; Boriani, Giuseppe; Wollmann, C; Biffi, M; Kuhl, M; Sperzel, J; Stiller, S; Gasparini, G; Bocker, D.
abstract

Atrial tachyarrhythmias are a common co-morbidity in patients with an ICD indication. Recently introduced ICD's are equipped to independently detect and treat atrial and ventricular tachyarrhythmias. The purpose of this prospective study was to evaluate the incidence and termination of spontaneous atrial and ventricular tachyarrythmias in patients with a history of atrial tachyarrhythmias. METHODS AND RESULTS: Ninety patients, 70% male with an ICD indication and history of atrial tachyarrhythmia (LVEF 45 +/- 6%, [AT/AF indication 55 +/- 10, AT/VT 45 +/- 16], 46% CAD) were enrolled and 89 were implanted with a VENTAK PRIZM AVT (Guidant). Spontaneous atrial and ventricular tachyarrhythmias were printed and evaluated during an average follow-up period of 272 +/- 72 days utilizing the stored intracardial electrogram function of the device. Nineteen patients (21%) presented had only atrial tachyarrhythmias, 32 patients (36%) had both atrial and ventricular tachyarrhythmias and 18 patients (20%) had only ventricular tachyarrhythmias. Patients with only atrial tachyarrhythmias had a total of 3274 atrial episodes; 2002 terminated spontaneously, 1264 were treated with ATP and 8 with shock therapy. ATP was successful in 735 (58%) of 1264 episodes. Patients with both atrial and ventricular tachyarrhythmias had 7277 documented atrial tachyarrhythmias, 5231 terminated spontaneously, 1153 of 2009 were terminated by ATP (57.4%) and 37 by shock therapy (20 patient controlled). Atrial tachyarrhythmias identified as atrial flutter (AT) by the atrial rhythm classification (ARC) algorithm had a higher ATP conversion success rate than episodes identified as atrial fibrillation (AF); 66.7% for AT and 26.4% for AF. Patients with only ventricular tachyarrhythmias had 690 documented episodes, 401 terminated spontaneously, 248 (85.8%) were terminated by ATP and 41 by shock. CONCLUSION: Seventy-seven percent of patients with an ICD indication had spontaneous atrial and/or ventricular tachyharrhythmias within the first 6 months after ICD implantation. ATP therapy terminated 58% of all atrial tachyarrhytmias and 66.7% of the atrial flutters. The dual chamber ICD detected, classified and terminated all ventricular tacharrhythmias appropriately.

2005 - La fibrillazione atriale e il controllo della frequenza ventricolare: approccio terapeutico e valutazione dell’efficacia del trattamento [Articolo su rivista]
Boriani, Giuseppe; I., Diemberger; M., Biffi; C., Martignani; C., Valzania; A., Branzi
abstract

N/A

2005 - La terapia di controllo della freuenza ventricolare nella fibrillazione atriale: razionale, metodologia e obiettivi [Articolo su rivista]
I., Diemberger; Boriani, Giuseppe; C., Rapezzi
abstract

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2005 - Letter regarding article by Bokhari et al, "Long-term comparison of the implantable cardioverter defibrillator versus amiodarone: eleven-year follow-up of a subset of patients in the Canadian Implantable Defibrillator Study (CIDS)" [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Martignani, C.
abstract

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2005 - Linee Guida AIAC 2006 all’impianto di pacemaker, dispositivi per la resincronizzazione cardiaca (CRT) e defibrillatori automatici impiantabili (ICD) [Articolo su rivista]
M., Lunati; Mg, Bongiorni; Boriani, Giuseppe; R., Cappato; D., Corrado; A. Curnis M., Di Biase; S., Favale; L., Padeletti; R., FE Pedretti; A., Proclemer; R., Ricci; M., Santini; P., Spirito; G., Vergara
abstract

Fin dalla loro prima introduzione, le Linee Guida hanno sempre avuto lo scopo di informare il medico sulle evidenze scientifiche riportate in letteratura ed indirizzarlo verso il trattamento più appropriato di specifiche patologie. Debbono cioè identificare dei gruppi di pazienti con determinate caratteristiche e suggerire per essi il trattamento che, in trial clinici randomizzati, abbia dimostrato di garantire il miglior risultato per il paziente. Purtroppo, molto spesso non sono disponibili per tutte le categorie di pazienti, dati scientifici che evidenzino con chiarezza i potenziali benefici o non benefici di specifici trattamenti e ciò determina l’esistenza di grandi “zone grigie” nelle quali, in assenza di supporti scientifici chiari, la decisione terapeutica rimane totalmente nelle mani del medico curante il quale è chiamato a valutare la situazione clinica di ogni paziente su base individuale

2005 - Lo scompenso cardiaco: ruolo della terapia elettrica di resincronizzazione [Articolo su rivista]
Boriani, Giuseppe; M., Biffi; C., Martignani; M., Ziacchi; P., Artale; D., Saporito; C., Valzania; I., Diemberger; F., Grigioni; C., Rapezzi; L., Frabetti; A., Branzi
abstract

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2005 - Long-term reduction of atrial tachyarrhythmia recurrences in patients paced for bradycardia-tachycardia syndrome. [Articolo su rivista]
Padeletti, L; Santini, M; Boriani, Giuseppe; Botto, G; Gulizia, M; Molon, G; Luzzi, G; Senatore, G; Giraldi, F; Zolezzi, F; Pieragnoli, P; Pro, F; Desanto, T; Grammatico, A.
abstract

Atrial tachyarrhythmias (AT) are considered progressive diseases. Several rhythm control therapies for treatment of AT have been proposed. OBJECTIVES: The Italian AT500 Registry was designed to prospectively study long-term AT evolution in patients paced for the brady-tachy form of sinus node disease (BT-SND). METHODS: Three hundred forty-six BT-SND patients received an antitachycardia dual-chamber pacemaker and were followed-up for a minimum of 12 months (median 19 months). Prevention and antitachycardia pacing (ATP) features were enabled in all patients. RESULTS: During the observation period, 224 (65%) patients were treated by antiarrhythmic drugs and 45 (13%) patients were cardioverted. Five patients suffered a stroke, 4 transient ischemic attack, 22 permanent AT, and 98 AT recurrences longer than 7 days. AT mean cycle length changed from 246 to 270 ms, and the percentage of patients with AT-related hospitalizations significantly decreased with an annual 28% relative reduction. AT burden and the percentage of patients with AT recurrences longer than 2 days remained constant with time in the overall population but decreased significantly in the subgroup of patients who did not develop permanent AT. High ATP efficacy was associated with an increasingly higher prevention of AT recurrences longer than 2 days. CONCLUSION: In a long-term observation of BT-SND patients, AT-related hospitalizations decreased significantly and mean AT cycle length increased significantly. The data suggest that rhythm control therapies induce inversion of AT progression.

2005 - Mechanisms of pain associated with internal defibrillation shocks: Results of a randomized study of shock waveform [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Silvestri, P; Martignani, C; Valzania, C; Diemberger, I; Moulder, C; Mouchawar, G; Kroll, M; Branzi, A.
abstract

Shock pain has limited the acceptance of the implantable atrial cardioverter and is a complication of ventricular implantable cardioverter-defibrillator therapy. Rounding off of the peak of a shock waveform reduces pain. Whether the pain reduction results from reduction in the peak voltage or from the rounding has not been established. In other words, does reducing the extreme dV/dt (voltage derivative) of the conventional truncated exponential capacitive discharge waveform reduce pain?

2005 - P wave dispersion and short-term vs. late atrial fibrillation recurrences after cardioversion [Articolo su rivista]
Boriani, Giuseppe; Diemberger, I; Biffi, M; Camanini, C; Valzania, C; Corazza, I; Martignani, C; Zannoli, R; Branzi, A.
abstract

P wave dispersion has been previously suggested as a potential tool for predicting the risk of recurrence of atrial fibrillation after electrical cardioversion. We investigated whether different P wave dispersion values are associated with recurrence of atrial fibrillation in the short (< or =1 month after cardioversion) and longer term. METHODS: In 37 patients with long-lasting persistent atrial fibrillation (mean duration 21 +/- 36 months) with (n = 19) or without (n = 18) amiodarone pretreatment as antiarrhythmic prophylaxis, maximum and minimum P wave duration and P wave dispersion were measured 1 min after internal cardioversion. RESULTS: P wave dispersion was lower in patients with amiodarone pretreatment (28.3 +/- 9.5 vs. 21.9 +/- 7.3 ms, P = 0.029). The subgroups of patients with recurrence of atrial fibrillation at 1 month or in the long-term did not differ from the rest of the study sample regarding age, sex, atrial fibrillation duration, left atrial dimensions or ejection fraction. P wave dispersion was significantly higher in patients with short-term atrial fibrillation recurrence (< or = 1 month) than in the rest of the population. Furthermore, P wave dispersion values >25 ms were associated with a higher short-term relapse rate. No significant relation was present in the long-term. CONCLUSIONS: Our results suggest that P wave dispersion analysis immediately after internal cardioversion may help predict short-term recurrences of atrial fibrillation. These findings may be related to different mechanisms and predisposing factors for short-term and late recurrences. The long-term predictive value of serial evaluations of P wave dispersion during follow-up deserves investigation.

2005 - Pacing with capture verification in candidates for resynchronisation therapy: A feasibility study [Articolo su rivista]
Biffi, M; Boriani, Giuseppe; Bertini, M; Silvestri, P; Martignani, C; Branzi, A.
abstract

Devices for cardiac resynchronisation therapy (CRT) deliver energy into 3 output channels. Such a burden can significantly reduce device longevity. Autocapture has been shown to improve pacemaker longevity and safety of right ventricular pacing in clinical studies. The aim of this study was to investigate the application of Autocapture during biventricular pacing (BIV) to decrease the energy cost of CRT. METHODS: During implantation of BIV devices, an acute study was performed to test the hypothesis that the evoked response (ER) elicited by each delivered stimulus is correctly detected and measured either on the right ventricular (RV) channel during BIV pacing with the left ventricular (LV) channel pacing first, or in the LV channel with the RV channel pacing first. A reliable measurement of ER is the critical requirement for the correct performance of Autocapture. RESULTS: ER amplitude in the right ventricle during BIV pacing was not significantly decreased compared with RV pacing in the VVI mode (16.36+/-5.27 mV vs 17.09+/-6.12 mV). ER amplitude in the left ventricle during BIV pacing was not significantly decreased compared with LV pacing in the VVI mode (12.4+/-8.95 mV vs 12.25+/-8.97 mV). Three patients in atrial fibrillation had a DDDR pacemaker with the LV lead connected to the atrial port, and received BIV pacing with Autocapture turned on in the RV channel. Autocapture performance in the long term, as assessed by the trend of RV threshold over 20+/-8 months, showed that LV depolarisation was never sensed as an ER on the RV channel. CONCLUSIONS: Our observations support the feasibility and safety of capture verification during BIV pacing on the ventricular channel paced secondly, which could increase the longevity of CRT devices, and decrease the costs of this new therapy for heart failure patients.

2005 - Pazienti con indicazione MADIT II: risultati del follow up del registro SEARCH MI. Poster Congresso Nazionale Associazione Cardiologi Ospedalieri (ANMCO) [Articolo su rivista]
Rahue, W; Santini, M; Boriani, Giuseppe; Proclemer, A; Lunati, M; Vergara, G; Comisso, I; Rizzo, V.
abstract

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2005 - Persistenza della vena cava superiore sinistra in candidati a pacemaker o cardioverter-defibrillatore: implicazioni pratico-cliniche. Abstract 66° Congresso Società Italiana di cardiologia [Articolo su rivista]
M., Bertini; M., Biffi; Boriani, Giuseppe; L., Frabetti; C., Martignani; A., Branzi
abstract

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2005 - Predictors of atrial antitachycardia pacing efficacy in patients affected by brady-tachy form of sick sinus syndrome and implanted with a DDDRP device. [Articolo su rivista]
Boriani, Giuseppe; Padeletti, L; Santini, M; Gulizia, M; Capucci, A; Botto, G; Ricci, R; Molon, G; Accogli, M; Vicentini, A; Biffi, M; Vimercati, M; Grammatico, A.
abstract

Predictors of ATP efficacy in brady/tachy patients. BACKGROUND: Recent options to treat atrial tachyarrhythmias (ATA) include implantable devices delivering antitachycardia pacing therapies (ATP). No prospective study selected patients with higher chances of episode termination by ATP or indicated the most effective ATP use. Our aim was to study ATP efficacy in patients with brady-tachy form of sinus node disease (SND), identifying clinical factors, ATA characteristics, and device features predicting ATP efficacy. METHODS AND RESULTS: Three hundred and sixteen patients (105 M, aged 71.1+/-8.8 years) received a DDDRP pacemaker and were prospectively followed. Median follow-up was 18 months: 37,125 ATA episodes occurred in 217 patients; ATP treated 5,536 of them. Overall, ATP efficacy was 50.0%. A multivariate analysis identified longer arrhythmia cycle lengths (OR=1.25; CI=1.07-1.47) and shorter delays to ATP delivery (OR=0.15; CI=0.10-0.22) as independent predictors of ATP efficacy for episodes preceded by >or=5 minutes of sinus rhythm. Additionally, ATP efficacy for all treated episodes was predicted by lower New York Heart Association (NYHA) class (OR=0.64; CI=0.42-0.98), episode classification as nonimmediate recurrence of ATA (non-IRAT) (OR=0.07; CI=0.02-0.33), absence of overlap in the device detection windows (OR=0.54; CI=0.32-0.91), and flecainide treatment (OR=2.22; CI=1.04-4.71). CONCLUSIONS: In patients paced for SND, multivariate analysis shows that ATP efficacy is associated to longer arrhythmia cycle lengths, shorter ATP delivery delays, NYHA class I, episode classification as non-IRAT, absence of overlap in the atrial arrhythmia device detection windows, and flecainide treatment.

2005 - Quantification of fatty tissue mass by magnetic resonance imaging in arrhythmogenic right ventricular dysplasia. [Articolo su rivista]
Fattori, R; Tricoci, P; Russo, V; Lovato, L; Bacchi Reggiani, L; Gavelli, G; Branzi, A; Boriani, Giuseppe
abstract

INTRODUCTION: Arrhythmogenic right ventricular dysplasia (ARVD) is a heart muscle disorder in which the pathological substrate is a fatty or fibro-fatty replacement of the right ventricular (RV) myocardium. METHODS AND RESULTS: Magnetic resonance imaging (MRI) studies were performed in 10 patients with arrhythmogenic right ventricular dysplasia and in 24 matched controls in order to assess right ventricular epicardial/intramyocardial fatty tissue mass, RV myocardial mass, and RV functional parameters. Functional abnormalities were found in all ARVD cases. Patients with ARVD showed increased fatty tissue compared to controls (8.2 +/- 4 g vs. 2.0 +/- 1.0 g; P = 0.001), whereas no significant differences were found in RV myocardial mass (29.5 +/- 9.2 g vs. 23.2 +/- 6.7 g; P = NS). A correlation coefficient between 0.87 and 0.97 was found for repeated measurements. CONCLUSION: Quantification of fatty tissue with MRI is feasible and constitutes an objective method for differentiating normal from pathological conditions. This approach may lead to a complete diagnostic assessment of ARVD with the potential application for monitoring the evolution of the disease.

2005 - Temporal variability of atrial tachyarrhythmia burden in bradycardia-tachycardia syndrome patients. [Articolo su rivista]
Padeletti, L; Santini, M; Boriani, Giuseppe; Botto, G; Capucci, A; Gulizia, M; Ricci, R; Spampinato, A; Pieragnoli, P; Warman, E; Vimercati, M; Grammatico, A.
abstract

Several studies have tested non-pharmacological therapies for atrial tachyarrhythmias (ATs) by measuring the cumulative time (burden) the patient spends in arrhythmia. Contradictory results questioned either therapy efficacy or statistical power of the trials. We studied AT burden variability in patients paced for sinus node disease (SND) in order to interpret currently published data appropriately and to evaluate reliable sample sizes. METHODS AND RESULTS: One hundred and five patients with AT and SND received a dual chamber pacemaker with antitachyarrhythmia-pacing capability, and were followed for 13 months. Seventy-eight patients (74%) suffered AT recurrences. Device-gathered diagnostic measures were used to simulate results of randomized studies both with crossover and parallel design. The sample size required for statistically significant results was calculated as a function of the expected therapy-induced burden reduction. AT burden intra-patient variability was high: 43% of patients showed intrinsic fluctuations hiding any therapy-induced burden reduction lower than 30%. Demonstrating therapeutic breakthrough through a 6 month study would require 290 patients with crossover design and 5800 patients with parallel design. Doubling the study period requires 400 and 3000 patients, respectively. CONCLUSION: Patients with AT and paced for SND showed high intra-patient burden variability, which could possibly hide an AT burden reduction induced by a therapy. Previous studies involving non-pharmacological therapies utilizing AT burden endpoints could lack the power to reach statistical significance.

2004 - Amyloid deposition as a cause of atrial remodelling in persistent valvular atrial fibrillation [Articolo su rivista]
Leone, O; Boriani, Giuseppe; Chiappini, B; Pacini, D; Cenacchi, G.; MARTIN SUAREZ, S; Rapezzi, C; BACCHI REGGIANI, Ml; Marinelli, G.
abstract

The spectrum of histological alterations, namely atrial amyloidosis, in the right and left atria of patients with chronic persistent atrial fibrillation (AF) and rheumatic heart disease is not completely known.

2004 - Atrial tachyarrhythmia recurrence temporal patterns in bradycardia patients implanted with antitachycardia pacemakers [Articolo su rivista]
R., Ricci; M., Santini; L., Padeletti; Boriani, Giuseppe; A., Capucci; Botto, G. L.; M., Gulizia; G., Inama; A., Galati; F., Solimene; M., Pepe; A., Grammatico
abstract

New-generation pacemakers allow continuous atrial tachyarrhythmia (AT) monitoring that provides accurate information about AT type, frequency, burden, and temporary evolution.

2004 - Cardiac resynchronization by pacing: an electrical treatment of heart failure [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Martignani, C; Fallani, F; Greco, C; Grigioni, F; Corazza, I; Bartolini, P; Rapezzi, C; Zannoli, R; Branzi, A.
abstract

Various modalities of cardiac pacing have been proposed in the past to improve hemodynamics, either directly or indirectly. Some of these are conventional ways of cardiac stimulation, others such as biventricular or left ventricular pacing, represent dedicated pacing techniques. Left ventricular and biventricular pacing are successfully applied in those patients with congestive heart failure who have conduction disturbances (i.e. left bundle branch block) as they correct the ensuing intra- and interventricular dyssynchrony. This is the reason why these pacing modalities are described as cardiac resynchronization therapy. According to the results of a series of studies, the cardiac resynchronization therapy seems to have a favourable clinical impact in terms of quality of life, morbidity and hospitalization rate. On-going and future studies should assess the impact of resynchronization therapy on overall mortality and its cost-effectiveness profile in specific subgroups of patients. Other open issues regard (i) the convenience of using biventricular pacing as a pacing-alone therapy or in combination with ventricular defibrillation capability, especially for potential candidates to heart transplantation, and (ii) the ways to identify properly the responders to resynchronization therapy.

2004 - Cardiac resynchronization therapy: Update on clinical studies [Articolo su rivista]
Boriani, Giuseppe; Biffi, Mauro; Martignani, Cristian; Ziacchi, Matteo; Saporito, Davide; Valzania, Cinzia; Diemberger, Igor; Bertini, Matteo; Domenichini, Giulia; Artale, Paolo; Frabetti, Lorenzo; Branzi, Angelo
abstract

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2004 - Clinical and therapeutic implications of troponin elevation in cardiac arrest [Articolo su rivista]
Boriani, Giuseppe; M., Biffi; C., Martignani
abstract

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2004 - Closed loop stimulation in prevention of vasovagal syncope. Inotropy controlled pacing in vasovagal syncope (INVASY): A multicentre randomized, single blind, controlled study [Articolo su rivista]
Occhetta, Eraldo; Bortnik, Miriam; Audoglio, Roberto; Vassanelli, Corrado; Roncarolo, Pierluigi; Chiodi, Leandro; Marcolongo, Marco; Torta, Davide; Zanetta, Marco; Boriani, Giuseppe; Pirisi, Raimondo; Mazza, Antonio; Marconi, Paolo; Igidbashian, Diran; Romano, Salvatore; Manfredini, Ruggero; Tondo, Claudio; Arlotti, Massimo; Chimienti, Marcello; Zamparelli, Luigi; Cioffi, Luciano; Carboni, Angelo; Bongiorni, Maria Grazia; Polimeni, Rocco; Sermasi, Sergio; Del Giudice, Giovanni; Croce, Adriano; Batista Tola, Giovanni; Terrosu, Pierfranco; Bellotti, Paolo; Gazzarata, Massimo; Libero, Luigi; Jorfida, Marcella; Bensoni, Mauro; Barbieri, Daniela; Lombroso, Sergio; Galati, Antonio; Salerno, Jorge; Caico, Salvatore; Bianchi, Enzo Maria; Glenzer, Renato; Zolezzi, Francesco; Negro, Roberto; Sassara, Massimo; De Luca, Fernando
abstract

Objectives: To determine whether dual-chamber rate-adaptive Closed Loop Stimulation (CLS) could prevent recurrence of Vasovagal Syncope (VVS). Background: During VVS, an increase in myocardial contractility associated with a reduction of ventricular filling produces an increase in baroreceptor afferent flow and a consequent decrease in the heart rate. The CLS algorithm is a form of rate-adaptive pacing, which responds to myocardial contraction dynamics, by measuring variations in right ventricular intracardiac impedance: during an incipient VVS it could increase paced heart rate and avoid bradycardia, arterial hypotension and syncope. Methods: Fifty patients (27 males, mean age 59 ± 18 year) with severe and recurrent vasovagal syncope and positive Head Up Tilt Test (HUTT) with cardioinhibition, received a CLS pacemaker (INOS2, Biotronik GmbH Co., Germany). The primary end point was recurrence of two VVSs during a minimum of 1 year of follow-up. Randomization between DDD-CLS and DDI mode (40 bpm) pacing was performed only during the first stage of the study (first year): 9/26 randomized to DDI mode (control group) and 17/26 in DDD-CLS mode. All the 24 patients recruited in the second stage of the study (second year) were programmed in DDD-CLS mode. Results: Of the nine patients randomized to the DDI mode, seven had recurrences of syncope during the first year. At the end of the first year the nine patients were reprogrammed to the CLS mode and no syncope occurred after reprogramming. The 41 patients programmed to CLS had a mean follow-up of 19 ± 4 months: none reported VVS, only four (10%) reported occasional presyncope and their quality of life greatly improved. Positive HUTT at the end of the first year failed to predict the clinical response to CLS pacing. Conclusions: The study demonstrates the effectiveness of CLS pacing in preventing cardioinhibitory VVS. A possible placebo effect of pacemaker implantation occurred in 22% of patients. © 2004 The European Society of Cardiology. Published by Elsevier Ltd. All rights reserved.

2004 - Efficacy of internal cardioversion for chronic atrial fibrillation in patients with and without left ventricular dysfunction. [Articolo su rivista]
Boriani, Giuseppe; Biffi, M.; Camanini, C.; Corazza, I.; Martignani, C.; Valzania, C.; Gallina, M.; Grigioni, F.; Zannoli, R.; Rapezzi, C.; Branzi, A.
abstract

Internal cardioversion can restore sinus rhythm with energies below 6-10 J, often without anaesthesia/sedation. We investigated its safety and short-/medium-term efficacy in patients with persistent atrial fibrillation (AF) with left ventricular dysfunction (defined as ejection fraction < or = 40%). Among 34 patients with persistent AF who agreed to receive internal cardioversion, 16 had left ventricular dysfunction and 18 did not (the groups were similar as regards age, duration of AF and pretreatment with amiodarone). Internal CV was performed delivering 3.0/3.0-ms biphasic shocks between coil catheters using a step-up protocol. Sinus rhythm was always restored. General anaesthesia (administered only when discomfort was not tolerated) was required only in 2 of the 16 (12.5%) patients with left ventricular dysfunction. The defibrillation threshold was similar in patients with and without left ventricular dysfunction (10.2+/-6.9 vs. 8.4+/-4.9 J; p=0.37). Short-term (within 72 h) AF recurrence rates in the presence and absence of left ventricular dysfunction were 19% (3/16) and 6% (1/18), respectively (p=0.51). After cardioversion, all patients received antiarrhythmic drugs (mostly amiodarone in patients with left ventricular dysfunction and class IC agents in the remainder). With mean follow-up periods of about 220 days, AF recurrence rates among patients with and without left ventricular dysfunction were 50% (8/16) and 28% (5/18), respectively (p=0.328). We conclude that even in patients with left ventricular dysfunction, internal CV is safe and effective, minimizing risks from anaesthesia. Although these patients may have a higher risk of short- or medium-term AF recurrence, 6-month maintenance of sinus rhythm is possible in about 50% of cases.

2004 - Far-field R wave oversensing in dual-chamber pacemakers designed for atrial arrhythmia management: effect of pacing site and lead tip to ring distance [Articolo su rivista]
G., Inama; M., Santini; L., Padeletti; Boriani, Giuseppe; G., Botto; A., Capucci; M., Gulizia; R., Riccci; P., Rizzon; F., Ferri; F., Miraglia; R., Raneri; A., Grammatico
abstract

INAMA, G., et al.: Far-Field R Wave Oversensing in Dual Chamber Pacemakers Designed for Atrial Arrhythmia Management: Effect of Pacing Site and Lead Tip to Ring Distance. The aim of the study was to determine the incidence and practical implications of far-field R wave oversensing (FFRWO) and its association with pacing site and lead tip to ring spacing (TTRS) in implantable devices designed to diagnose and treat atrial tachyarrhythmias and programmed with a fixed and short postventricular blanking period. The study included 395 patients who were implanted with a DDDRP pacemaker and prospectively followed. At implant and follow-up visits FFRWO was assessed by analyzing lead electrical measures and atrial tachyarrhythmic episodes collected in the device diagnostics. During a median follow-up of 12 months 11 (2.8%) of 395 patients showed a clinically significant FFRWO that induced inappropriate detection or pacemaker malfunctioning. The atrial pacing site of these 11 patients was right atrium appendage (RAA) for 3 patients, representing 1.1% of 254 RAA patients, coronary sinus ostium (CSO) for 7 patients, representing 7.4% of 94 CSO patients (P < 0.005 vs RAA), and lateral wall (LW) for 1 (2.9%) of 34 LW patients. The minimal value of the FFRWO to P wave ratio, measured at implant, associated with a clinically significant FFRWO was 0.6; therefore, a value of 0.5 was used as a cutoff to identify patients at risk of undesirable device behavior induced by FFRWO: there were 11 (9.6%) of 114 of RAA patients with short (< or = 10 mm) TTRS, 22 (18.8%) of 117 of RAA patients with long (> or = 17 mm) TTRS (P < 0.05 vs short TTRS), 21 (30.6%) of 64 of CSO patients short TTRS (P < 0.001 vs RAA patients with short TTRS) and 3 (30%) of 10 of CSO patients with long TTRS. The analysis showed that, despite the short postventricular blanking time, FFRWO inducing undesired functioning in AT500 pacemakers is infrequent (2.8% of patients). Compared to RAA, the CSO lead position was more frequently associated with FFRWO.TTRS < 10 mm was associated with lower risk of clinically significant FFRWO in RAA. (PACE 2004; 27:1221-1230).

2004 - Fusion beat detection in ICDs with a new ventricular automatic capture detection algorithm [Articolo su rivista]
Boriani, Giuseppe; Biffi, J. S. P. E. R. Z. E. L. M.; T., Schwartz; A., Konig; S., Temporin; Y., Dong; S., Meyer:
abstract

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2004 - Implications of cardiac resynchronization therapy and prophylactic defibrillator implantation among patients eligible for heart transplantation [Articolo su rivista]
Pedone, C.; Grigioni, F.; Boriani, Giuseppe; Lofiego, C.; Vassallo, P. L.; Potena, L.; Coccolo, F.; Magnani, G.; Biffi, M.; Martignani, C.; Frabetti, L.; Zannoli, R.; Magelli, C.; Branzi, A.
abstract

This study analyzed the relations and time-related changes in eligibility for cardiac resynchronization therapy and prophylactic defibrillator implantation in 161 potential candidates for heart transplantation. Although up to 62% of patients who fulfilled the severity criteria for heart transplantation were eligible for either device, this percentage increased as clinical/instrumental parameters of heart failure severity worsened.

2004 - Increase in QT/QTc dispersion after low energy cardioversion of chronic persistent atrial fibrillation. [Articolo su rivista]
Boriani, Giuseppe; Valzania, C.; Biffi, M.; Corazza, I.; Camanini, C.; Martignani, C.; Bacchi, L.; Zannoli, R.; Branzi, A.
abstract

The effects of atrial internal cardioversion on QT interval and QT dispersion (parameters associated with increased risk of ventricular tachyarrhythmias) are unknown. We investigated changes in QT interval, QTc and QT dispersion immediately after shock delivery for internal cardioversion in patients with chronic persistent atrial fibrillation.

2004 - Pattern and temporal occurrence of spontaneous atrial and ventricular tachyarrhythmias in patients with a history of atrial tachycardia after ICD implantation [Articolo su rivista]
Boriani, Giuseppe; A., Schuckert; M., Kuhl; C., Wollmann
abstract

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2004 - Perché i risultati dei trias clinici sulla terapia elettrica delle tachiaritmie atriali fino ad oggi pubblicati non sono ancora conclusivi? Una valutazione di metodo del registro italiano AT 500 [Articolo su rivista]
L., Padeletti; A., Coltella; R., Ricci; Boriani, Giuseppe; P., Rizzon; R., Favilli; F., Pasqualini; A., Grammatico; F., Pro; M., Santini
abstract

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2004 - Pharmacological cardioversion of atrial fibrillation: current management and treatment options. [Articolo su rivista]
Boriani, Giuseppe; Diemberger, I; Biffi, M; Martignani, C; Branzi, A.
abstract

Atrial fibrillation (AF) is the most common form of arrhythmia, carrying high social costs. It is usually first seen by general practitioners or in emergency departments. Despite the availability of consensus guidelines, considerable variations exist in treatment practice, especially outside specialised cardiological settings. Cardioversion to sinus rhythm aims to: (i) restore the atrial contribution to ventricular filling/output; (ii) regularise ventricular rate; and (iii) interrupt atrial remodelling. Cardioversion always requires careful assessment of potential proarrhythmic and thromboembolic risks, and this translates into the need to personalise treatment decisions. Among the many clinical variables that affect strategy selection, time from onset is crucial. In selected patients, pharmacological cardioversion of recent-onset AF can be a safely used, feasible and effective approach, even in internal medicine and emergency departments. In most cases of recent-onset AF, pharmacological cardioversion provides an important--and probably more cost effective--alternative to electrical cardioversion, which can then be employed as a second-line therapy for nonresponders. Class IC agents (flecainide or propafenone), which can be safely used in hospitalised patients with recent-onset AF without left ventricular dysfunction, can provide rapid conversion to sinus rhythm after either intravenous administration or oral loading. Although intravenous amiodarone requires longer conversion times, it is still the standard treatment for patients with heart failure. Ibutilide also provides good conversion rates and could be used for AF patients with left ventricular dysfunction (were it not for high costs). For long-lasting AF most pharmacological treatments have only limited efficacy and electrical cardioversion remains the gold standard in this setting. However, a widely used strategy involves pretreatment with amiodarone in the weeks before planned electrical cardioversion: this provides optimal prophylaxis and can sometimes even restore sinus rhythm. Dofetilide may also be capable of restoring sinus rhythm in up to 25-30% of patients and can be used in patients with heart failure. The potential risk of proarrhythmia increases the need for careful therapeutic decision making and management of pharmacological cardioversion. The results of recent trials (AFFIRM [Atrial Fibrillation Follow-up Investigation of Rhythm Management] and RACE [Rate Control versus Electrical Cardioversion for Persistent Atrial Fibrillation]) on rate versus rhythm control strategies in the long term have led to a generalised shift in interest towards rate control. Although carefully designed studies are required to better define the role of pharmacological rhythm control in specific AF settings, this alternative option remains a recommendable strategy for many patients, especially those in acute care.

2004 - Prevention of sudden death in hypertrophic cardiomyopathy: but which defibrillator for which patient ? [Articolo su rivista]
Boriani, Giuseppe; B., Maron; Wk, Shen; P., Spirito
abstract

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2004 - Rate control in AFFIRM: Considerations about the clinical implications [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Martignani, C; Branzi, A.
abstract

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2004 - Rhythm control and increased risk of noncardiovascular death in the Atrial Fibrillation Follow-up Investigation of Rhythm Management trial [Articolo su rivista]
Boriani, Giuseppe; Biffi, M.; Mattioli, S.
abstract

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2004 - Solution to a crushing dosage problem? [Articolo su rivista]
Bronzetti, G; Canzi, A; Boriani, Giuseppe; Giardini, A; Picchio, F.
abstract

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2004 - Ventricular fibrillation during sleep in an adolescent with hypertrophic cardiomyopathy: the difficulty of risk stratification and the power of the cardioverter-defibrillator [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Rapezzi, C; Coccolo, F; Branzi, A.; Spirito, P.
abstract

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2003 - 108th ENMC International Workshop, 3rd Workshop of the MYO-CLUSTER project: EUROMEN, 7th International Emery-Dreifuss Muscular Dystrophy (EDMD) Workshop, 13-15 September 2002, Naarden, The Netherlands. [Relazione in Atti di Convegno]
Bonne, G; Yaou, Rb; Béroud, C; Boriani, Giuseppe; Brown, S; de Visser, M; Duboc, D; Ellis, J; Hausmanowa Petrusewicz, I; Lattanzi, G; Merlini, L; Morris, G; Muntoni, F; Opolski, G; Pinto, Ym; Sangiuolo, F; Toniolo, D; Trembath, R; van Berlo, Jh; van der Kooi, Aj; Wehnert, M.
abstract

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2003 - Abnormal cardiac innervation in patients with idiopathic ventricular fibrillation [Articolo su rivista]
Biffi, M; Fallani, F; Boriani, Giuseppe; Fanti, S; Kowoll, L; Pettinato, C; Monetti, N; Branzi, A.
abstract

Idiopathic ventricular fibrillation (VF) is diagnosed in up to nearly 10% of survivors of out-of-hospital cardiac arrest. The arrhythmogenic substrate is unknown. This study examined the role of cardiac innervation as a possible contributor to this arrhythmia. Eight patients with idiopathic VF were compared with eight normal subjects (controls) by [(123)] I metaiodobenzylguanidine SPECT (MIBG), measuring peak uptake, late uptake, and clearance of the nuclear tracer. The left ventricle was divided in 13 segments in the bull's-eye target plot. Peak and late MIBG uptake was increased in the anterolateral segments (2,3,7,8) compared to the inferoposterior and septal segments, in controls and in patients. No difference was observed between controls and patients in the inferoposterior and septal segments. In contrast, a significantly higher MIBG uptake was observed in patients compared to controls in the anterolateral segments (94 4% vs 81 +/- 11%, P < 0.03 for peak uptake; 94 +/- 5% vs 79 +/- 12%, P < 0.01 forlate uptake). No difference was observed in MIBG clearance in any segment in either study group. Cardiac sympathetic innervation is highly heterogeneous, though predominant in anterolateral segments in normal subjects. Patients with idiopathic VF exhibit the same distribution, though have a significantly greater density of sympathetic terminals in the anterolateral segments than controls, which may promote ventricular arrhythmias. (PACE 2003;26[Pt.II]:357-360).

2003 - Atrial evoked response integral for automatic capture verification in atrial pacing [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Cameron, D; Datteri, S; Snell, J; Holmstrom, N; Park, E; Bornzin, Ga
abstract

Beat-by-beat Autocapture is currently limited to operation in the ventricle with bipolar leads. The authors investigated the integral of the negative-going portion of the atrial evoked response integral (AERI) as a potential resource for verification of atrial capture. Intracardiac electrogram signals were collected from 59 patients (ages 67.8 +/- 15.1 years) with bipolar, low polarization atrial leads. The signals were collected over a mean period of 6.1 months (minimum 4 days) after lead implantation. St. Jude Medical Affinity pulse generators were used to perform automatic capture threshold tests while the electrogram signals were recorded by a Model 3510 programming device. These signals were transferred to a personal computer in digital form for later analysis. The AERI was calculated at each programmable pacing voltage until capture was lost. The difference between the polarization integral at loss of capture and evoked response integral with successful capture was sufficient to justify enabling the atrial Autocapture feature in 53 of 59 patients in whom bipolar pacing and unipolar sensing was performed. The authors developed a calibration routine to identify automatically those patients in whom atrial Autocapture could be programmed On, based on the polarization integral at loss of capture, the estimated maximum polarization integral, and the AERI. Preliminary analysis indicated that the AERI is a practical resource for beat-by-beat atrial capture detection when used with low polarization leads.

2003 - Atrial remodeling: evolving concepts [Articolo su rivista]
Biffi, Mauro; Boriani, Giuseppe
abstract

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2003 - Cardiac resynchronization and implantable cardioverter defibrillator therapy: Preliminary results from the InSync Implantable Cardioverter Defibrillator Italian Registry [Articolo su rivista]
Gasparini, M; Lunati, M; Bocchiardo, M; Mantica, M; Gronda, E; Frigerio, M; Caponi, D; Carboni, A; Boriani, Giuseppe; Zanotto, G; Ravazzi, Pa; Curnis, A; Puglisi, A; Klersy, C; Vicini, I; Cavaglia, S.
abstract

The aim of this study was to evaluate ventricular arrhythmias occurring in recipients of the InSync ICD for the primary and secondary prevention of sudden death. The InSync ICD was implanted in 142 patients (128 men; mean age 65 +/- 10 years) with heart failure (mean NYHA functional Class 3.0 +/- 0.7) and wide QRS (mean 159 +/- 33 ms). The underlying etiology was ischemic in 55%, idiopathic in 33%, and valvular or hypertensive cardiomyopathy in 12% of patients. The numbers of arrhythmic episodes/100 patient-months was computed with their 95% CI, assuming a Poisson distribution. Implants were performed in 48 (34%) patients who did not have an ACC/AHA guidelines Class I indication for ICD therapy. A total of 104 patients were compliant for follow-up visits. During a 9-month median (range 0.1-24) follow-up of 104 compliant patients, 19 experienced a total of 94 ventricular arrhythmias, all successfully interrupted or selfterminated, with a median number of two separate episodes, corresponding to a rate of 10 episodes/100 person-month (95% CI 8-12). A rate of 12 episodes/100 person-months (95% CI 10-15) was measured in the subgroup of patients with ACC/AHA class I indications, versus two episodes/100 person-months (95% CI 1-5) in the remainder of the population. Among 12 deaths, 9 were due to heart failure, 1 to a noncardiovascular cause, and 2 to unknown causes. The implantation of ICD in heart failure patients has been prominently extended to primary prevention. Patients without standard ICD indications experienced life-threatening arrhythmic events. The impact of ICD combined with cardiac resynchronization therapy on arrhythmic profile, mortality, and costs in this subgroup of patients need to be more precisely studied, with a particular focus on the various types of underlying heart disease.

2003 - Cardioverter-defibrillators after MADIT-II: the balance between weight of evidence and treatment costs. [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Martignani, C; Camanini, C; Grigioni, F; Rapezzi, C; Branzi, A.
abstract

The possibility of using implantable cardioverter-defibrillators (ICDs) for primary prevention of sudden death in selected high-risk patients has prompted a series of prospective controlled studies. Recently, the MADIT II study highlighted the possibility of effective primary prevention of sudden death in patients with coronary artery disease selected by straightforward clinical data and without expensive screening (electrophysiological study). For patients with previous myocardial infarction and low left ventricular ejection fraction (</=30%), ICD implantation may reduce mortality risk by approximately 31% in the following 2 years. Implementation of this therapeutic strategy threatens to impact on public health-care spending. Possible cost-limiting mechanisms include price cuts because of increasing usage (market forces); identification of subgroups at higher risk of sudden death and use of cheaper devices with limited diagnostic and therapeutic options. Further long-term evaluation of the cost-effectiveness and cost-utility of ICDs should identify subgroups of patients for whom implantation is affordable despite current economic constraints. For heart failure patients, randomized controlled trials are currently evaluating the effects on overall survival of both conventional ICDs and devices with biventricular pacing capabilities. In this perspective, data from the COMPANION trial are expected to stimulate the use of devices with defibrillation back-up in candidates for biventricular pacing.

2003 - Clinical relevance of atrial fibrillation/flutter, stroke, pacemaker implant, and heart failure in Emery-Dreifuss muscular dystrophy - A long-term longitudinal study [Articolo su rivista]
Boriani, Giuseppe; Gallina, M; Merlini, L; Bonne, G; Toniolo, D; Amati, S; Biffi, M; Martignani, C; Frabetti, L; Bonvicini, M; Rapezzi, C; Branzi, A.
abstract

Background and Purpose-Emery-Dreifuss muscular dystrophy (EDMD) is a rare inherited disorder associated with cardiac involvement. We investigated the spectrum and relevance of the cardiac manifestations of EDMD, focusing on bradyarrhythmias and tachyarrhythmias (including atrial fibrillation/flutter), embolic stroke, and heart failure. Methods and Results-Eighteen patients (age 42.8+/-19.6 years) with genetically confirmed X-linked (n=10, including 3 carriers) or autosomal dominant (n=8) EDMD were followed for a period ranging from 1 to 30 years in a research center for neuromuscular diseases and in a university cardiological department. Pacemakers were required by 10 of 18 (56%) patients for bradyarrhythmia, and related complications occurred in 3 of 10 (30%) cases. Atrial fibrillation/flutter developed in 11 of 18 (61%) patients, with atrial standstill subsequently occurring in 5 of 11 (45%) cases and embolic stroke (most often disabling) in 4 of 11 (36%). Heart failure requiring transplantation occurred in 1 of 18 (6%) patients, and asymptomatic left ventricular dysfunction in a further 3 (17%). No relationship was evident between neuromuscular impairment and cardiac involvement. Conclusions-Both X-linked and autosomal dominant EDMD patients risk not only bradyarrhythmia (requiring pacemaker implant) but also atrial fibrillation/flutter, which often anticipates atrial standstill and can cause disabling embolic stroke at a relatively young age. Antithromboembolic prophylaxis has to be recommended in EDMD patients with atrial fibrillation/flutter or atrial standstill. With careful monitoring, survival after pacemaker implant may be long. Heart failure, which seems to occur only in a minority of patients, may be severe.

2003 - Effect of left ventricular function on long-term left ventricular pacing and sensing threshold [Articolo su rivista]
Tse, Hf; Yu, C; Paul, Ve; Boriani, Giuseppe; Schuchert, A; del Ojo, Jl; Malinowski, K; Blanc, Jj; Lau, Cp
abstract

Background: The effect of left ventricular (LV) systolic function on the long-term left ventricular pacing and sensing threshold is unclear. Methods and Results: We studied the effect of LV ejection fraction (LVEF) on the LV pacing and sensing threshold in 56 patients (mean age: 70.2 +/- 10.5 years) underwent permanent LV pacing using a self-retaining coronary sinus lead (Model 1055 K, St Jude Medical, USA). In 49 patients, the LV lead was implanted for conventional pacemaker indication (sick sinus syndrome = 14, heart block = 26 or slow atrial fibrillation = 9). The remaining 7 patients were implanted for congestive heart failure. The LV pacing and sensing threshold, and lead impedance were compared between patients with LVEF <40% ( Group 1, n = 28) and LVEF >40% (Group 2, n = 28) during implant and at 3-month follow up. The LV pacing lead was successfully implanted in all patients without any lead dislodgement on follow-up. At implant, Group 1 patients had a significant lower R wave amplitude, but similar LV pacing threshold and lead impedance as compared to Group 2. However, at 3-month follow-up, Group 1 patients had a significantly higher LV pacing threshold compared to Group 2 patients. There were no significant differences in the sensing threshold and lead impedance between the two groups. Furthermore, there was also a significant interval increase in LV pacing threshold in Group 1 patients (0.94 +/- 0.12 V) after 3 months, but not in Group 2 patients (0.16 +/- 0.08 V, p < 0.01). Conclusions: The results of this study suggest that the LV systolic function has a significant impact on the long-term LV pacing threshold. The long-term left ventricular pacing threshold in patients with left ventricular systolic dysfunction increased after implant and was higher than patients with normal left ventricular systolic function.

2003 - Evaluation of a dual chamber implantable cardioverter defibrillator for the treatment of atrial and ventricular arrhythmias [Articolo su rivista]
Boriani, Giuseppe; Wollmann, C; Biffi, M; Kuhl, M; Schuchert, A; Sperzel, J; Stiller, S; Gasparini, G; Bocker, D.
abstract

Eighty-nine patients with a documented history of atrial tachyarrhythmias or fibrillation (AF) received a cardioverter defibrillator designed to selectively differentiate and treat atrial and ventricular arrhythmias. Twenty-two patients received a coronary sinus lead and, therefore, could use a separate shock vector for selective treatment of atrial tachyarrhythmias/AE The device is designed to treat tachyarrhythmias with antitachycardia pacing (ATP) and/or shock therapy using an atrial and/or a ventricular shock vector. Patients underwent induction and shock termination of atrial or dual tachyarrhythmias (AF/VF) to verify proper device function and to measure the arrhythmia detection time with enhancements and preventive algorithms programmed On and Off, respectively. Detection time for 329 VF inductions was 2.41 +/- 0.64 seconds with enhancements On and 2.29 +/- 0.47 with enhancements Off (NS). At implant or predischarge, 283 AF and/or AF/VF (121 atrial and 162 atrial/ventricular fibrillation) were induced. Shock conversion efficacy was 89.8% with AF conversion energies ranging from 0.9 to 27 J. Thirteen of the 23 patients had atrial shock conversions using the separate shock vector with an average conversion energy of 1.9 +/- 1.41. (range 0.5-5 J) A During follow-up the efficacy of ATP on atrial tachyarrhythmias was 59% and the efficacy of delivered shocks on AF was 85%. This new dual chamber cardioverter defibrillator appropriately detected and classified atrial arrhythmias, and shock therapy for AF was highly effective. The detection algorithm differentiated atrial tachyarrhythmia/AF and did not delay VF detection. The separate shock vector converted induced AF with energies ranging from 0.6 to 5 J.

2003 - Fluttering waves in electrocardiograms recorded in neonatal intensive care unit [Articolo su rivista]
Bronzetti, G; Canzi, A; Picchio, Fm; Boriani, Giuseppe
abstract

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2003 - Late improvement in ventricular performance following internal cardioversion for persistent atrial fibrillation: An argument in support of concealed cardiomyopathy [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Rapezzi, C; Ferlito, M; Bronzetti, G; Bacchi, L; Zannoli, R; Branzi, A.
abstract

The aim of the study was to evaluate the time course of atrial and ventricular function improvement following internal atrial cardioversion in patients with structural heart disease. Twenty-nine patients with chronic persistent atrial fibrillation (AF) and underlying structural heart disease were followed by serial echocardiograms performed at 1 and 6 hours, 1 day, 1, 2, and 3 weeks, and 1, 2, 3, and 6 months after successful cardioversion. Sinus rhythm was maintained at 6 months in 24 patients. Following cardioversion the time course of left atrial mechanical function (peak A wave, percent A wave filling) differed from that of left ventricular ejection fraction: peak A wave values (cm/s) increased significantly at 1 week (51 +/- 23 vs 35 +/- 15 at 1 hour, P < 0.05), percent A wave filling (%) increased significantly at 2 weeks (34 +/- 12 vs 22 +/- 9 at 1 hour, P < 0.05), whereas left ventricular ejection fraction (%) increased later (at 1 month 60 +/- 14 vs 55 +/- 14 at baseline, P < 0.05 and at 2 months 60 +/- 14 vs 56 +/- 14 at 1 hour, P < 0.05). In conclusion, restoration of sinus rhythm results in an improvement in left ventricular ejection fraction during follow-up, even in patients with structural heart disease without fast ventricular rates at baseline. The dissociation between the time course of atrial and ventricular function improvement suggests that the latter was partly due to regression of a concealed form of cardiomyopathy and/or of a ventricular dysfunction due to chronic AF.

2003 - Mutation analysis of the lamin A/C gene (LMNA) among patients with different cardiomuscular phenotypes [Articolo su rivista]
Vytopil, M; Benedetti, S; Ricci, E; Galluzzi, G; Dello Russo, A; Merlini, L; Boriani, Giuseppe; Gallina, M; Morandi, L; Politano, L; Moggio, M; Chiveri, L; Hausmanova Petrusewicz, I; Ricotti, R; Vohanka, S; Toman, J; Toniolo, D.
abstract

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2003 - QRS interval time-related changes and prognosis in heart failure [Articolo su rivista]
Grigioni, F; Boriani, Giuseppe; Magelli, C; Branzi, A.
abstract

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2003 - Rate control in atrial fibrillation: choice of treatment and assessment of efficacy [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Diemberger, I; Martignani, C; Branzi, A.
abstract

The clinical relevance and high social costs of atrial fibrillation have boosted interest in rate control as a cost-effective alternative to long-term maintenance of sinus rhythm (i.e. rhythm control). Prospective studies show that rate control (coupled with thromboembolic prophylaxis) is a valuable treatment option for all forms of atrial fibrillation. The rationale for rate control is that high ventricular rates, frequently found in atrial fibrillation, lead to haemodynamic impairment, consisting of a variable combination of loss of atrial kick, irregularity in ventricular response and inappropriately rapid ventricular rate, depending on the type of underlying heart disease. Long-term persistence of tachycardia at a high ventricular rate can lead to various degrees of ventricular dysfunction and even to tachycardiomyopathy-related heart failure. Identification of this reversible and often concealed form of left ventricular dysfunction can permit effective management by rate (or rhythm) control. Although acute rate control (to reduce ventricular rate within hours) is still often based on digoxin administration, for patients without left ventricular dysfunction, calcium channel antagonists or beta-adrenoceptor antagonists (beta-blockers) are generally more appropriate and effective. In chronic atrial fibrillation, long-term rate control (to reduce morbidity/mortality and improve quality of life) must be adapted to patients' individual characteristics to grant control during daily activities, including exercise. According to current guidelines, the clinical target of rate control should be a ventricular rate below 80-90 bpm at rest. However, in many patients, assessment of the appropriateness of different drugs should include exercise testing and 24h-Holter monitoring, for which specific guidelines are needed. In practice, rate control is considered a valid alternative to rhythm control. Recent prospective trials (e.g. the Pharmacological Intervention in Atrial Fibrillation [PIAF] and the Atrial Fibrillation Follow-up Investigation of Rhythm Management [AFFIRM] trials) have shown that in selected patients, rate control provides similar benefits, more economically, in terms of quality of life and long-term mortality. The choice of a rate control medication (digoxin, beta-blockers, calcium channel antagonists or possibly amiodarone) or a non-pharmacological approach (mainly atrioventricular node ablation coupled with pacing) must currently be based on clinical assessment, which includes assessing the presence of underlying heart disease and haemodynamic impairment. Definite guidelines are required for each different subset of patients. Rate control is particularly tricky in patients with heart failure, for whom non-pharmacological options can also be considered. The preferred pharmacological options are beta-blockers for stabilised heart failure and digoxin for unstabilised forms.

2003 - Rhythm discrimination by rate branch and QRS morphology in dual chamber implantable cardioverter defibrillators [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Dall'Acqua, A; Martignani, C; Frabetti, L; Zannoli, R; Branzi, A.
abstract

Morphology Discrimination is a discriminator based on QRS morphology analysis that has been recently implemented in dual chamber implantable cardioverter defibrillators (ICDs). Detected events are initially classified according to median atrial and ventricular rates (Rate Branch). Then, a series of discriminators (Morphology Discrimination, Stability, Sudden Onset) analyze the rhythm according to specific criteria and the number of discriminators required for VT diagnosis (i.e., requiring "any" or "all" of the specific discriminators to indicate VT). The discriminating accuracy of the algorithm was evaluated in 645 detections recorded during the follow-up of 25 patients. The overall specificity for 397 supraventricular arrhythmias was 73.5% (292/397) with the tachycardia diagnosis criteria set to "any" and 90.9% (361/397) with the tachycardia diagnosis criteria set to "all." Sensitivity for VT was 100% and 98.7% (231/234) with the tachycardia diagnosis criteria set to "any" and "all," respectively. With the tachycardia diagnosis criteria set to "any," specificity for atrial fibrillation was 88.6%, for atrial flutter 40.3%, for atrial tachycardia 0%, and for sinus tachycardia 97.0%. With the tachycardia diagnosis criteria set to "all, " specificity for atrial fibrillation was 92.40%, for atrial flutter 93.5%, for atrial tachycardia 54.7%, and for sinus tachycardia 99.0%. The contribution of Morphology Discrimination was crucial to improve the specificity of the Rate Branch algorithm. The implementation of Morphology Discrimination in a dual chamber ICD with Rate Branch rhythm classification allows the attainment of high specificity and high sensitivity for ventricular tachyarrhythmias.

2003 - Serial versus isolated assessment of clinical and instrumental parameters in heart failure: Prognostic and therapeutic implications [Articolo su rivista]
Grigioni, F; Barbieri, A; Magnani, G; Potena, L; Coccolo, F; Boriani, Giuseppe; Specchia, S; Carigi, S; Musuraca, A; Zannoli, R; Magelli, C; Branzi, A.
abstract

Background In heart failure (HF), it is not known whether analysis of serial changes in prognostic parameters provides incremental information with respect to comprehensive isolated clinical and instrumental assessments. Methods We analyzed time-related changes in a period greater than or equal to6 months in a broad panel of clinical and instrumental (electrocardiographic, echocardiographic, hemodynamic, and cardiopulmonary) parameters in 105 patients with HF (age, 53 +/- 10 years; 88% men; 55% New York Heart Association classification III-IV; E F, 24% +/- 6%). Results Among the time-related parameters, QRS widening (adjusted RR per 10 ms, 1.21; 95% CI. 10-1.48; P=.003) and peak oxygen uptake (pVO2) decrease (adjusted RR per mL/Kg/min, 1.11; 95% CI, 1.01-1.22; P =.034) provided independent, incremental information for predicting cardiac death/need for heart transplantation (CD/HT) with respect to the entire panel of isolated readings. The overall rate of CD/HT-free survival after 12 months was 60% +/- 5%. Patients who were clinically stable with QRS widening and pVO2 decrease values of < 10% had a better CD/HT event-free survival rate at 1 year (92% +/- 5% vs 50% +/- 6%; P <.001). Conclusions This study indicates that analysis of time-related changes in prognostic parameters provides relevant incremental prognostic information and may help in the risk stratification of patients with HF and the selection of candidates for HT. In particular, patients who were clinically stable and had QRS widening and a pVO2 decreases <10% in a period &GE;6 months appear to be characterized by a good prognosis and may not be suitable candidates for HT.

2002 - A randomised cross-over study on the haemodynamic effects of oral dofetilide compared with oral sotalol in patients with ischaemic heart disease and sustained ventricular tachycardia [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Bacchi, L; Martignani, C; Zannoli, R; Butrous, Gs; Branzi, A.
abstract

Objective: To assess the haemodynamic effects of short-term treatment with dofetilide in comparison with sotalol in patients with ischaemic heart disease. Methods: Twelve patients with ischaemic heart disease and sustained ventricular tachycardia were treated with dofetilide [500 mug twice daily (b.i.d.)] or sotalol (160 mg b.i.d., randomised sequence separated by wash-out period) for 3-5 days. Right-heart catheterisation was performed at baseline and at the end of each short-term treatment phase. Results: The main findings were a significant reduction in heart rate, mean systemic pressure and cardiac index (-13%) during treatment with sotalol. Conversely, cardiac index increased significantly during dofetilide (mean percentage change 11%) with no effect on heart rate and systemic blood pressure. Conclusions: Oral dofetilide exerts favourable haemodynamic effects in comparison with D,L-sotalol following short-term oral treatment. In view of these observations, the use of dofetilide may be proposed also in patients with ventricular tachyarrhythmias associated with impaired left-ventricular function. Whether the haemodynamic differences between dofetilide and D,L-sotalol are the basis for differences in tolerability remains to be evaluated.

2002 - Accelerated QRS widening as an independent predictor of cardiac death or of the need for heart transplantation in patients with congestive heart failure [Articolo su rivista]
Grigioni, F; Carinci, V; Boriani, Giuseppe; Bracchetti, G; Potena, L; Magnani, G; Bacchi Reggiani, L; Magelli, C; Branzi, A.
abstract

We analyzed QRS interval for 6 months or more in 82 patients with dilated cardiomyopathy. At 1 year, the incidence of cardiac death/need for heart transplantation was higher among patients with QRS-interval widening of 0.5 msec/month or greater (p = 0.002). At multivariate analysis, QRS widening independently and unfavorably predicted cardiac death/need for heart transplantation (p = 0.029). Randomized prospective studies are necessary to confirm the prognostic value of accelerated QRS widening in patients with dilated cardiomyopathy and to investigate its significance in selecting candidates for electrical resynchronization and heart transplantation.

2002 - Atrial fibrillation precipitating sustained ventricular tachycardia in hypertrophic cardiomyopathy [Articolo su rivista]
Boriani, Giuseppe; Rapezzi, C; Biffi, M; Branzi, A; Spirito, P.
abstract

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2002 - Atrial fibrillation recurrence after internal cardioversion: prognostic importance of electrophysiological parameters [Articolo su rivista]
Biffi, M; Boriani, Giuseppe; Bartolotti, M; Reggiani, Lb; Zannoli, R; Branzi, A.
abstract

Objective: To evaluate the clinical and electrophysiological determinants of arrhythmia recurrence in patients undergoing internal atrial cardioversion for chronic atrial fibrillation (AF). Setting: Tertiary cardiac referral centre. Methods: 101 consecutive patients with failed external cardioversion or AF greater than or equal to 1 year underwent internal atrial cardioversion; once stable sinus rhythm (SR) was obtained, electrophysiological study was performed in 73 patients (72%) who gave informed consent. Patients were then followed on antiarrhythmic treatment. Results: 101 consecutive patients underwent internal atrial cardioversion in the period 1996-1999 with 100% conversion to SR; prophylactic antiarrhythmic treatment was flecainide (52%), amiodarone (37%), and sotalol (11%). Average follow up at first AF recurrence was 18.4 (14.4) months (range 0.1-49.8 months); persistence of SR was observed in 72/101 (72%) patients. By logistic regression, AF duration (odds ratio (OR) 1.07, 95% confidence interval (0) 1.01 to 1.13) and a lower sinus rate at discharge on antiarrhythmic drugs (OR 0.92, 95% CI 0.85 to 0.99) were independent predictors of AF recurrence, whereas age, New York Heart Association functional class, left atrial dimensions, and left ventricular ejection fraction were not predictive of arrhythmia recurrence. When electrophysiological parameters were added to the statistical model in 73 patients, a shorter atrial effective refractoriness (OR I 04, 95% CI 1 to 1.08) and an abnormal relation of atrial effective refractoriness to cycle length (OR 31, 95% CI 3.7 to 266) were also independent predictors of AF recurrence at follow up, beyond AF duration and heart rate at discharge. Conclusions: Patients with failed external cardioversion or long lasting AF may benefit from internal atrial cardioversion and antiarrhythmic treatment to keep SR at long term; electrophysiological study may identify patients at the highest risk of arrhythmia recurrence, Although preservation of SR seems unlikely for AF duration &gt; 3 years, a consistent minority of this subgroup (38%) may benefit from this approach.

2002 - Atrial signal analysis and defibrillation threshold assessment in chronic persistent and reinduced atrial fibrillation [Articolo su rivista]
Boriani, Giuseppe; Bartolini, P; Biffi, M; Calcagnini, G; Camanini, C; Corazza, I; Zannoli, R; Barbaro, V; Branzi, A.
abstract

Introduction: Induced versus spontaneous atrial fibrillation (AF) is of interest for assessing atrial defibrillation threshold reproducibility. Methods and Results: Twenty-one patients with chronic AF underwent internal cardioversion with assessment of atrial defibrillation threshold at baseline and at reinduced AF. High right atrial (HRA) and coronary sinus (CS) bipolar recordings were analyzed to measure the mean local atrial period, its coefficient of variation, the 5th (P5) and 95th (P95) percentiles of atrial intervals, and the percentage of points lying at the baseline (number of occurrences), and to quantify AF organization. Atrial defibrillation threshold was comparable in baseline and reinduced AF in terms of leading-edge voltage and delivered energy. Baseline and reinduced AF were comparable with regard to overall signal parameters (both in HRA and CS) and the presence of an organized arrhythmia pattern. As for individual variables, P5 increased while P95 and coefficient of variation decreased in reinduced AF compared with spontaneous AF (statistical significance was achieved for all these parameters in HRA, but only for coefficient of variation and P95 in CS). Conclusion: Sustained AF reinduced after cardioversion of chronic AF is comparable with baseline AF in terms of atrial defibrillation threshold, atrial cycle length, and pattern of organization. Therefore, a clinical model based on reinduction of sustained AF after cardioversion is suitable for studying the effects of a series of interventions on atrial defibrillation threshold. However, because this model does not yield a form of AF with comparable indices of local refractoriness (e.g., P5), it is not recommended when analyzing local electrophysiologic properties.

2002 - Combined use of morphology discrimination, sudden onset, and stability as discriminating algorithms in single chamber cardioverter defibrillators [Articolo su rivista]
Boriani, Giuseppe; Occhetta, E; Pistis, G; Menozzi, C; Jorfida, M; Sermasi, S; Pagani, M; Gasparini, G; Musso, G; Dall'Acqua, A; Biffi, M; Branzi, A.
abstract

Morphology Discrimination (MD) is a rhythm discriminator based on QRS morphology analysis that can be combined with other discriminators like Stability, with or without Sinus Interval History (SIH) and Sudden Onset. Thirty-five patients implanted with a St. Jude Medical single chamber ICD were evaluated during exercise testing, during induced AF, and during follow-up for 14 +/- 5 months. At exercise testing (60 episodes detected) MD had a specificity (SP) of 96.7% and Sudden Onset a SP of 91.7%; during induced AF (25 episodes) both MD and Stability had a SP of 96.0%. The diagnostic performance on spontaneous arrhythmias was as follows:for ventricular tachycardia (126 episodes) a sensitivity (SE) of 94.4% for MD, 92.1% for Sudden Onset, 89.7% for Stability without SIH and 79.4% for Stability + SIH, for sinus tachycardia (44 episodes) a SP of 86.4% for MD, 97.7% for Sudden Onset, 2.3% for Stability and of 95.5% for Stability + SIH. For AF (165 cases) a SP of 67.9% for MD, 69,1% for Stability and 90.3% for Stability + SIH, 44.8% for Sudden Onset. Use of MD alone provided a SE of 94.4% and a SP of 71.4% for spontaneous arrhythmias and combined use of the discriminators in a "2 of 3 " diagnostic logic implied a SP of 90.9% with maintenance of 96.0% of SE. In single chamber ICDs a wide range of SE/SP ratios may be obtained by use of multiple discriminators, but use of the algorithm in a 2 of 3 diagnostic logic may achieve a SP of 90.9% and a SE of 96.0%.

2002 - Current clinical perspectives on implantable devices for atrial defibrillation [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Martignani, C; Luceri, R; Bartolini, P; Branzi, A.
abstract

The role of devices that deliver shock therapy for atrial fibrillation is still debated. Following technical improvements in catheter-based atrial defibrillation, implantable devices have become available either in the form of stand-alone atrial defibrillators or in the form of dual defibrillators. Although preliminary results do not support their use as a single, unique treatment for atrial fibrillation patients, in combination with drugs, pacing or other treatments such as ablation, atrial defibrillators should help appropriately selected groups of patients.

2002 - Hypertrophic cardiomyopathy with massive hypertrophy, amiodarone treatment and high defibrillation threshold at cardioverter-defibrillator implant [Articolo su rivista]
Boriani, Giuseppe; Rapezzi, C; Biffi, M; Branzi, A.
abstract

N/A

2002 - Oral loading with propafenone for conversion of recent-onset atrial fibrillation - A review on in-hospital treatment [Articolo su rivista]
Boriani, Giuseppe; Martignani, C; Biffi, M; Capucci, A; Branzi, A.
abstract

Atrial fibrillation (AF) is a very common arrhythmia. In order to treat acute AF rapidly, effective drug regimens are required. Propafenone is a class IC antiarrhythmic agent that is suitable for oral loading as it reaches peak plasma concentrations within 2 to 4 hours of administration. The use of propafenone loading in patients with AF must be based on appropriate patient selection in view of the negative inotropic effect and the potential proarrhythmic effects of the drug. A series of controlled trials in patients with recent-onset AF without heart failure who were hospitalised with enforced bed rest has shown that orally loaded propafenone (450 to 600mg as single dose) exerts a relatively quick effect (within 3 to 4 hours) and a high rate of efficacy (72 to 78% within 8 hours). A potentially harmful effect of class IC agents is the risk of transforming AF into atrial flutter (3.5 to 5% of patients). However, atrial flutter with 1 : 1 atrioventricular response was observed in only two of 709 patients receiving propafenone (0.3% incidence). Nevertheless, the potential negative inotropic effect of propafenone demands careful patient selection, with systematic exclusion of patients with left ventricular dysfunction or congestive heart failure. Oral loading with propafenone can be considered as an episodic treatment in patients with AF recurrences, as has been proposed for other drugs in the past. However, the safety of oral loading with propafenone as an outpatient treatment in appropriately selected patients has to be assessed by appropriately designed prospective studies.

2002 - Transvenous internal cardioversion for atrial fibrillation: A randomized comparison between catheters with different coil length [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Camanini, C; Sammali, A; Bacchi, L; Accorti, P; Luceri, R; Zannoli, R; Branzi, A.
abstract

Objectives The aim of this study was to evaluate the effects of 2 different right atrial electrode coil lengths on energy and voltage requirements for transvenous atrial cardioversion. Methods Twenty-six patients (mean age 61+/-11 years) with chronic persistent atrial fibrillation (AF) (mean duration 11+/-10 months) underwent transvenous cardioversion. A 6F catheter with a 5.5-cm coil was positioned in the coronary sinus. Another catheter with either a 5.5-cm or an 8-cm coil was positioned along the lateral wall of the right atrium, according to a randomized allocation. R wave-synchronized biphasic shocks were delivered according to a step-up protocol. After cardioversion of baseline AF, AF was reinduced, the right atrial catheter was substituted, and cardioversion was repeated with the alternative right atrial coil. Results successful cardioversion was obtained in all of the patients. Leading edge voltage of effective shocks was significantly lower when catheters with an 8-cm coil in right atrium were used compared with the alternative 5-cm coil catheters (301+/-80 volts vs 340+/-78 volts, P<.001); and delivered energy (6.75&PLUSMN;4.25 joules vs 7.86&PLUSMN;4.29 joules, P=.043) and shock impedance (60&PLUSMN;9 ohm vs 66&PLUSMN;10 ohm, P<.001) were lower. Moreover, shock-induced discomfort, evaluated by assessment of pain score, was reduced (3.69+/-1.09 vs 4.12+/-0.99, P=.035). Conclusions The use of a longer right atrial coil results in lower shock impedance, lower energy and voltage requirements, and lower discomfort during transvenous atrial cardioversion. The results of the current study are of value either for transvenous internal cardioversion of chronic persistent AF or for implantable atrial defibrillators.

2002 - [Implantable defibrillators and prevention of sudden death: clinical and economic implications in the light of the MADIT II study]. FT Defibrillatori impiantabili e prevenzione della morte improvvisa: implicazioni cliniche ed economiche alla luce dello studio MADIT II. [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Martignani, C; Branzi, A.
abstract

The cardioverter-defibrillator is the most effective strategy to prevent sudden death in patients with previous episodes of ventricular tachyarrhythmia (secondary prevention of sudden death). In recent years the possibility of primary prevention of sudden death in selected groups of high risk patients has raised great interest. The MADIT II study highlighted the possibility of preventing sudden death in patients with coronary artery disease. According to this trial, identification of such patients can be performed by means of few clinical data and without expensive screenings (i.e. electrophysiological study). Indeed, patients with a previous myocardial infarction and low left ventricular ejection fraction (&lt; 30%) may benefit from the implant of a cardioverter-defibrillator, with a reduction of the mortality risk by about 31% in the following two years. In the light of these data, implant of a cardioverter-defibrillator should be proposed in such patients, even if the problem of limited economic resources to meet the cost of the devices has to be considered even in the richest country of the world. Despite the positive scientific result, MADIT II has raised the problem of the effective possibility of adopting this therapeutic strategy in clinical practice and this question is still open. Strategies to reduce the theoretically high costs implicated by the MADIT II study include a reduction in the cost of defibrillators through dynamic market forces, the identification of subgroups at higher risk of sudden death, and the use of cheap defibrillators with limited diagnostic and therapeutic options. A long-term evaluation of the cost-effectiveness for western countries of these strategies is necessary to identify in which patient subgroups implant of a cardioverter-defibrillator is acceptable, i.e. cost-effective, in terms of primary prevention.

2001 - A multicentre, double-blind randomized crossover comparative study on the efficacy and safety of dofetilide vs sotalol in patients with inducible sustained ventricular tachycardia and ischaemic heart disease [Articolo su rivista]
Boriani, Giuseppe; Lubinski, A; Capucci, A; Niederle, P; Kornacewicz Jack, Z; Wnuk Wojnar, Am; Borggrefe, M; Brachmann, J; Biffi, M; Butrous, Gs
abstract

Background Antiarrhythmic drugs are still used for the treatment of ventricular tachyarrhythmias. in combination with implantable cardioverter-defibrillators or without them. Aim of the study In a double-blind randomized crossover design, the short- and long-term efficacy and safety of oral dofetilide or oral sotalol were compared in 135 patients with ischaemic heart disease and inducible sustained ventricular tachycardia. Methods The inducibility of ventricular tachycardia was determined by programmed electrophysiological stimulation at baseline. Patients were then blindly randomized to receive either oral dofetilide 500 mug twice daily or oral sotalot 160 mg twice daily, for 3 to 5 days. Suppression of inducible ventricular tachycardia on the drug was then assessed by programmed elect ro physiological stimulation. After a wash-out period of at least 2-5 days. the patients received the alternative treatment for 3 to 5 days. Suppression of inducible ventricular tachycardia on the alternate drug was again determined by programmed electrophysiological stimulation. Selection of long-term treatment was allocated blindly according to programmed electrophysiological stimulation results. Results During the acute phase, 128 patients received both dofetilide and sotalol. Sixty-seven patients were responders to either drug. Forty-six patients (35(.)9%) were responders to dofetilide compared with 43 (33(.)6%) to sotalol (P=ns). Only 23 patients responded to both dofetilide and sotalol. Adverse events, deemed to be treatment related, were seen in 2(.)3% of patients receiving dofetilide and 8(.)6% of patients receiving sotalol (P=0(.)016). Three patients on dofetilide had torsade de pointes. Two patients receiving sotalol died during the acute phase (one was arrhythmic death, and the other was due to heart failure). During the long-term phase, two of 42 patients (4(.)8%) receiving dofetilide and three of 27 patients (11(.)1%) receiving sotalol withdrew from treatment due to lack of efficacy. Overall, during the long-term phase, 23(.)8% of the patients receiving dofetilide and 37(.)0% of the patients receiving sotalol. withdrew from treatment with a similar pattern of withdrawals for the two drugs. Conclusion Dofetilide was as efficacious as sotalol, in preventing the induction of sustained ventricular tachycardia. There was no concordance in the response rate in two-thirds of the patients. Dofetilide was significantly better tolerated during the acute phase than sotalol. Both dofetilide and sotalol were well tolerated during the long term with no statistically significant difference in the adverse events.

2001 - A semi-automatic algorithm for reducing the time spent on routine follow-up of cardioverter defibrillators [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Renzi, R; Capestro, F; Pierantozzi, A; Sgarbi, E; Scarfo, S; Alboni, P; Migani, L; Sallusti, L; Frabetti, L; Branzi, A.
abstract

Background. The routine follow-up of cardioverter defibrillators (CD) is a time-consuming procedure. Aim of the Study and Methods. The present study was a prospective randomized cross-over evaluation on the clinical usefulness of a specific semi-automatic software algorithm (Quick Check) for CD follow-up, available in CPI Guidant systems (CD and programmer). Time-saving, while ensuring all the required data and patient safety, was evaluated in a large group of patients (105), recruited in different centers. In the same session and under a physician's supervision all patients underwent a follow-up with the aid of Quick Check or a standard follow-up, in a randomized sequence. Each patient served as his own control. Results. In the overall population of 105 patients, the time spent for follow-up was reduced by Quick Check from 186+/-105 sec to 106+/-67 sec (p <0.0001) (43% reduction). The reduction in time spent for follow-up with Quick Check was the same (43% reduction) in patients with detected episodes (n=38) (from 241+/-144 sec to 138+/-95 sec (p <0.0001)) and in patients without detected episodes (n=67) (from 154+/-52 sec to 88+/-34 sec (p <0.0001)). No adverse events or deletion of potentially useful data was detected by the supervising physician. Conclusions. Use of a specific software algorithm for routine follow-up of implanted CDs allows a significant shortening of the time spent on routine follow-up, thus reducing costs. The supervision of a physician is a guarantee of patient safety.

2001 - Analysis and processing of cardiac electrograms in atrial fibrillation: Preface [Articolo su rivista]
Barbaro, Vincenzo; Bartolini, Pietro; Calcagnini, Giovanni; Boriani, Giuseppe
abstract

N/A

2001 - Antitachycardia pacing therapies to terminate atrial tachyarrhythmias: the AT500 Italian Registry [Articolo su rivista]
Disertori, M; Padeletti, L; Santini, M; Dini, P; Gasparini, M; Inama, G; Botto, M; Boriani, Giuseppe; Capucci, A; Ricci, R; Gramegna, L; Del Greco, M; Grammatico, A; Vimercati, M.
abstract

Background Antitachycardia pacing (ATP) therapies may have a role to play in treating paroxysmal atrial tachy-arrythmias. The Medtronic AT500 is a new DDDRP pacemaker providing automatic ATP therapies and prevention algorithms. Method A total of 131 patients (age 71 +/- 9 years, 71 mate and 60 female) were enrolled in the AT500 Italian Registry after receiving the device. After implant, diagnostic features were enabled. They classify arrhythmias as atrial fibrillation (AF) or atrial tachycardia (AT) according to their rate, atrioventricular association and regularity. ATP therapies and prevention algorithms were enabled at first month follow-up visit. ATP therapies were programmed to treat episodes classified as AT at their onset or during their progression. Therapies were automatically delivered 1 min after episode detection. Results During a follow up of 3.3 +/- 2.9 months, 5593 AT/AF episodes were detected and treated in 21 patients, and 2065 (36%) were classified by the device as successfully terminated. In a subgroup of patients for whom electrogram information was available, the device classified 96 (37.4%) of the 256 recorded episodes as successfully terminated. The effect of ATP on AF burden was closely related to the efficacy of ATR A reduction in AF burden was more evident in those patients in whom ATP therapy efficacy was greater than 50% in terminating episodes. ATP efficacy was greater (52.6%) in episodes classified at onset as AT than in those classified at onset as AF (28.6%). ATP efficacy was also higher in patients with long pre-therapy P-P cycle interval and in patients with atrial lead implanted at the inter-atrial septum. Conclusion The present study demonstrates the safety and efficacy of automatic ATP therapies for terminating AT/AF with a sophisticated dual-chamber pacemaker. Atrial ATP terminated 36.9% of treated AT/AF episodes without any proarrhythmic effects in a population of patients with indications for pacemaker implantation and/or a history of AF (C) 2001 The European Society of Cardiology.

2001 - Antitachycardia pacing, therapy to treat spontaneous atrial tachyarrhythmias: the 7250 dual defibrillator Italian Registry [Articolo su rivista]
Ricci, R; Pignalberi, C; Disertori, M; Capucci, A; Padeletti, L; Botto, G; Boriani, Giuseppe; Miraglia, F; de Santo, T; Santini, M.
abstract

Background The dual defibrillator is a new device that can deliver atrial antitachycardia pacing (ATP) and shock therapies to treat atrial tachyarrhythmias in patients with and without life-threatening ventricular tachyarrhythmias. The aims of the present study were to investigate the efficacy of ATP and to identify factors that may impact on success of treatment. Method A total of 105 patients (80 male, mean age 64 +/- 10 years) implanted with a dual defibrillator were enrolled in the study;, 66% had documented atrial fibrillation (AF) before implantation and 14% had no history of prior ventricular tachyarrhythmias. Results The follow-up lasted 6 +/- 5 months (range 1-24 months). A total of 863 treated atrial episodes were analyzed; 54.8% were classified as AF and 45.2% as atrial tachycardia (AT). The positive predictive value for atrial tachyarrhythmia was 97.7%. The efficacy of atrial ATP therapy was as follows: 48% overall, 70.9% on AT and 24.3% on AF. The overall efficacy of atrial shock was 100% for AT and 80% for AF. Atrial burst+ and ramp efficacy correlated well with atrial arrhythmia cycle length, whereas 50-Hz burst did not. As ATP delivery delay increased from 0 to 30 min, the mean atrial arrhythmia cycle length shortened and ATP efficacy decreased. Class IC drug treatment was associated with longer mean atrial cycles as compared with no therapy or with class III drugs. Conclusion ATP therapies afforded by dual defibrillators were highly effective in treating spontaneous atrial tachyarrhythmias. Early treatment of such arrhythmias should improve success rates and patient benefits. (C) 2001 The European Society of Cardiology.

2001 - Clinical evaluation of morphology discrimination: An algorithm for rhythm discrimination in cardioverter defibrillators [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Frabetti, L; Lattuca, Jj; Branzi, A.
abstract

The aim of this study was to test the new morphology discrimination diagnostic algorithm for ICDs that differentiates supraventricular tachycardias (SVTs) from VTs by analysis of ventricular depolarization complexes morphology. Twenty-five patients implanted with a St. Jude Ventritex single chamber ICD were studied during electrophysiological evaluation at predischarge and were followed for 7 +/- 4 months. Sensitivity and specificity for VT detection and overall diagnostic accuracy of the morphology discrimination algorithm were calculated on 326 detected events. At electrophysiological evaluation, the algorithm was tested during 67 episodes of right atrial pacing, during 119 episodes of RV pacing (at basal interventricular septum and RV apex) and during 27 episodes of sustained AF: specificity was 98%, sensitivity was 66%, and diagnostic accuracy was 80%. Ah episodes of AF were correctly diagnosed as SVT. Exclusion of detections related to pacing at the basal interventricular septum, resulted in a specificity of 98%, a sensitivity of 85%, and a diagnostic accuracy of 93%. During follow-up, evaluation of the morphology discrimination algorithm on 113 spontaneous episodes (31 VTs, 31 AF, 7 SVTs, and 44 sinus tachycardias) exhibited a specificity of 89%, a sensitivity of 100%, and a diagnostic accuracy of 92%. In conclusion, the morphology discrimination algorithm exhibits a high specificity in discriminating VTs from SVTs, although with a corresponding reduction in sensitivity. The preliminary experience on spontaneous episodes is promising. To correct for the reduction in sensitivity, it is advisable to use this algorithm in parallel with other algorithms for rhythm discrimination (sudden onset, stability) coupled with extended high rate.

2001 - Cost-effectiveness of implantable cardioverter-defibrillators [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Martignani, C; Gallina, M; Branzi, A.
abstract

N/A

2001 - Effects of consistent atrial pacing and atrial rate stabilization - two pacing algorithms to suppress recurrent paroxysmal atrial fibrillation in brady-tachy syndrome [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Padeletti, L; Spampinato, A; Botto, Gl; Pignalberi, C; Grammatico, A; Hettrick, Da; De Seta, F; Branzi, A.
abstract

Background and method Recently, various dedicated atrial pacing algorithms have been proposed to prevent atrial fibrillation (AF). Consistent atrial pacing (CAP; an algorithm for automatic atrial overdrive) and atrial rate stabilization (ARS; an algorithm for preventing the 'short-long' sequences) were tested in 16 patients with brady-tachy syndrome and recurrent paroxysmal AF (greater than or equal to3 episodes per month). Results In the population as a whole, pacing with CAP was associated with a significant reduction in AF burden in comparison with DDDR pacing. With regard to the effects on AF burden, 11 patients (69%) were found to benefit significantly from CAP or ARS pacing algorithms (reduction &gt; 50% in AF burden). In detail, seven patients were responders to both algorithms, two to CAP only and two to ARS only. Two patients exhibited a significant increase in AF burden with the ARS algorithm. With regard to the effects on number of mode switches per day, seven patients (44%) were found to benefit significantly from CAP or ARS pacing algorithms (reduction in mode switches per day &gt; 50%). In detail, five patients were responders to both algorithms and two to ARS only. Two patients had a significant increase in the number of mode switches per day with both CAP and ARS algorithms. Conclusion The response to ARS and CAP algorithms is heterogeneous. In 31-69% of patients with brady-tachy syndrome a significant reduction in AF burden and/or mode switch episodes can be obtained with ARS and/or CAP algorithms; however, in a few patients an increase in AF episodes and/or AF burden may occur. (C) 2001 The European Society of Cardiology.

2001 - Impact of consistent atrial pacing algorithm on premature atrial complexe number and paroxysmal atrial fibrillation recurrences in brady-tachy syndrome: A randomized prospective cross over study [Articolo su rivista]
Ricci, R; Santini, M; Puglisi, A; Azzolini, P; Capucci, A; Pignalberi, C; Boriani, Giuseppe; Botto, Gl; Spampinato, A; Bellocci, F; Proclemer, A; Grammatico, A; de Seta, F.
abstract

Aim of the study: The Consistent Atrial Pacing (CAP) algorithm has been designed to achieve a high percentage of atrial pacing to suppress paroxysmal atrial fibrillation. The aim of our study was to compare the impact of DDDR+CAP versus DDDR pacing on paroxysmal atrial fibrillation recurrences and triggers in patients with Brady-Tachy Syndrome. Methods: 61 patients, 23 M and 38 F, mean age 75 +/-9 y, affected by Brady-Tachy Syndrome, implanted with a DDDR pacemaker, were randomized to DDDR or DDDR+CAP pacing with cross over of pacing modality after 1 month. Results: 78% of patients in DDDR pacing and 73% in DDDR+CAP pacing (p=n.s.) were free from symptomatic paroxysmal atrial fibrillation recurrences. During DDDR+CAP pacing, the atrial pacing percentage increased from 77 +/- 29% to 96 +/-7% (p <0.0001). Automatic mode switch episodes/day were 0.73 +/-1.09 in DDDR and 0.79 +/-1.14 (p=n.s.) in DDDR+CAP. In patients with less than 50% of atrial pacing during DDDR, automaticmode switch episodes/day decreased during DDDR+CAP from 1.13 +/-1.59 to 0.23 +/-0.32 (p <0.05) and in patients with less than 90% from 1.23 +/-1.27 to 0.75 +/-1.10 (p <0.001). The number of premature atrial complexes per day decreased during DDDR+CAP from 2665 +/- 4468 to 556 +/- 704 (p <0.02). Conclusion: CAP algorithm allowed continuous overdrive atrial pacing without major side effects. Triggers of paroxysmal atrial fibrillation induction, such as premature atrial complexes, were critically decreased. Paroxysmal atrial fibrillation episodes were reduced in patients with atrial pacing percentage lower than 90 % during DDDR pacing.

2001 - Implantable cardioverter defibrillators for ventricular tachyarrhythmia: current status and technological evolution [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Martignani, C; Bartolini, P; Branzi, A.
abstract

N/A

2001 - Internal low energy atrial cardioversion: Efficacy and safety in older patients with chronic persistent atrial fibrillation [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Magagnoli, G; Zannoli, R; Branzi, A.
abstract

BACKGROUND: Low-energy internal atrial cardioversion is a relatively new technique based on delivery of intracardiac shocks through transvenous catheters placed into the atria or the vessels. OBJECTIVE: The aim of this study was to assess in older and younger patients with chronic persistent atrial fibrillation (AF) the efficacy and safety of transvenous low-energy internal atrial cardioversion performed without routine administration of sedatives or anesthetics. DESIGN: A prospective longitudinal study. SETTING: A cardiological university hospital. PARTICIPANTS: 82 patients, divided into older (greater than or equal to 60 years) (n = 49) and younger (n = 33) subjects. MEASUREMENTS: Atrial defibrillation threshold for internal cardioversion, measured as leading edge voltage (V) and delivered energy (J) of effective shocks, percentage of patients maintaining sinus rhythm at short-term (within 3 days) and at long-term follow-up. METHODS: Patients with chronic persistent AF, treated with oral anticoagulants for at least 3 to 4 weeks, were admitted to hospital. Following a clinical work-up, patients were subjected to low-energy internal atrial cardioversion with shock delivery according to a step-up protocol. RESULTS: Internal cardioversion was effective in restoring sinus rhythm in 90% (44/49) of the older patients and in 94% (31/33) of the younger patients. Shocks were effective at a mean energy between 6 and 8 joules (range 0.9-23) and administration of sedatives or anesthetics was required during the procedure in 22% (11/49) of older and in 48% (16/33) of younger patients (P = .026 at chi-square). No major complications occurred during the procedure. Pharmacological prophylaxis of AF recurrences was instituted immediately following the procedure. During inhospital stay and during the follow-up (mean 12 +/- 9 months for older patients and 15 +/- 10 months for younger patients), AF recurred in 39% (17/44) of older patients and in 16%, (5/31) of younger subjects (P = .064 at chi-square). CONCLUSIONS: Internal low energy cardioversion is a very effective procedure For restoring sinus rhythm in patients with AF; it can be performed in older patients, and administration of sedatives or anesthetics can be avoided or minimized in a substantial proportion of subjects. Recurrences of AF in the long term tend to be higher in older subjects and intensive prophylaxis with antiarrhythmic drugs is required.

2001 - Left superior vena cava persistence in patients undergoing pacemaker or cardioverter-defibrillator implantation: a 10-year experience [Articolo su rivista]
Biffi, M; Boriani, Giuseppe; Frabetti, L; Bronzetti, G; Branzi, A.
abstract

Objective: The persistence of a left superior vena cava (I,SVC) has been observed in 0.3% of the general population as established by autopsy. In the adult population, it is an important anatomic finding if a left superior approach to the heart is considered. The aim of the study was to evaluate the prevalence of a LSVC in patients undergoing pacemaker (PM) and cardioverter-defibrillator (CD) implantation. Design: We observed the prevalence of LSVC during a 10-year period; each patient undergoing PM or transvenous CD implantation received a left cephalic/left subclavian venous approach to the heart. With this technique, LSVC persistence is easily diagnosed during lead placement. Results: A total of 1,139 patients consecutively underwent PM implantation during 10 years: 4 patients had persistent LSCV (0.34%). Among 115 patients undergoing CD implantation, 2 patients with LSVC (1.7%) were observed, Overall LSVC persistence was found in 6 of 1,254 patients (0.47%), Two patients, one of whom had no light superior vena cava (RSVC), received a left-sided PM, whereas two other patients received right-sided devices. Both CD patients received a left-sided active-can device: the first patient with a right-sided lead tunneled to the left pectoral pocket, as a result of poor catheter handling through the LSVC and coronary sinus, and the second patient with a screw-in lead from]LSVC. Long-term follow-up of these patients (average +/- SD, 41 +/- 26 months) revealed absence of lead dislodgment and appropriate device function regardless of lead implantation site. Conclusions: Persistence of LSVC in adults undergoing PM/CD implantation is similar to that of the general population (0.47% in our study), The left-sided implant can be achieved by stylet shaping and by use of active fixation leads in most patients, with a reliable outcome at short term in addition to appropriate device performance at follow-up. Assessment of the RSVC is advisable when planning a right-sided implantation, since a minority of patients lacks this vessel.

2001 - Management of patients with atrial fibrillation: different therapeutic options and role of electrophysiology-guided approaches. [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Camanini, C; Corazza, I; Bartolini, P; Calcagnini, G; Barbaro, V; Zannoli, R; Branzi, A.
abstract

At present the approach to atrial fibrillation treatment is based on the electrophysiological patterns of atrial fibrillation (on the basis of multiple intra-atrial recordings or sophisticated new mapping techniques) only in a restricted minority of patients, those who are candidate to ablation of the substrate and/or of the triggers. Atrial fibrillation has a broad spectrum of clinical presentations and a heterogeneous electrophysiological pattern. The treatment of this arrhythmia, both with drugs and non pharmacological treatments, has been based, classically, on empirical basis and on a clinically-guided staged-approach. The limitations of pharmacological treatment led in recent years to the development of a wide spectrum of non pharmacological treatments. This implies a change in the approach to atrial fibrillation and the need to identify potentially ideal candidates to complex and expensive treatments. In this view it is currently under investigation the possibility to identify potential responders to a definitive treatment or a combination of treatments (both pharmacological and non-pharmacological) on the basis of the electrophysiological pattern.

2001 - Neurocardiogenic syncope in selected pediatric patients - Natural history during long-term follow-up and effect of prophylactic pharmacological therapy [Articolo su rivista]
Biffi, M; Boriani, Giuseppe; Bronzetti, G; Frabetti, L; Picchio, Fm; Branzi, A.
abstract

Objective: The natural history of pediatric patients with severely symptomatic neurocardiogenic syncope is poorly defined respect to the likelihood of remission or symptomatic recurrence along time. We undertook this study to investigate the likelihood of clinical relapse, and to assess the effect of prophylactic pharmacological treatment in the most symptomatic patients. Methods: Twenty-nine patients with neurocardiogenic syncope were studied at our Institution: 14 (12 +/- 3.6 years) highly symptomatic received prophylactic therapy with beta -blockers guided by head up tilt (HUT), whereas 15 (12.2 +/- 2.7 years) moderately symptomatic received only education to avoid triggering of the vasovagal reflex and to abort forthcoming syncope. Patients were then followed respectively for 33.7 +/- 9.0 and 33.3 +/- 8.7 months (p = NS). Results: The average duration of symptoms before HUT was 9.0 +/- 4.3 months (range 3-17) for treated patients, and 6.2 +/- 2.5 months (range 2-11) for those untreated (p < 0.05). Treated patients had also a greater number of symptomatic events: 6 +/- 2 vs. 2 +/- 1 (p < 0.001). During follow up, 9/15 untreated and 6/14 treated patients had at least I recurrence, with an odds ratio of 2 (95% Cl 0.72-5.49). Clinical events were greatly reduced in both groups at follow up, but treated patients had a significantly greater reduction either of syncopal (p < 0.001) or near syncopal events (p < 0.02). Time to the first recurrence, syncope or near syncope, was shorter for untreated vs treated patients: 5 +/- 2 vs. 25 +/- 12 months (p < 0.001). Looking at the time course of all clinical recurrences, 23/26 occurred in untreated patients, whereas 7/10 occurred in treated patients within 24 months. An attempt to therapy discontinuation was made after 30 months in 4 patients, and resulted in half of them being asymptomatic, and half with a single minor recurrence. Conclusions: Spontaneous reduction of symptoms occurs along time in pediatric patients with neurocardiogenic syncope, so that recurrences are very unlikely after 24 months from first diagnosis. Tiered prophylactic therapy may be guided by HUT in selected highly symptomatic patients; <beta>-blockers appear a very effective intervention. Larger, prospective controlled studies are required to investigate the role of any intervention in moderately symptomatic patients.

2001 - New options for pharmacological conversion of atrial fibrillation [Articolo su rivista]
Boriani, G.
abstract

N/A

2001 - Nightmares and sleep disturbances with simvastatin and metoprolol [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Strocchi, E; Branzi, A.
abstract

N/A

2001 - Randomized crossover comparison of right atrial appendage pacing versus interatrial septum pacing for prevention of paroxysmal atrial fibrillation in patients with sinus bradycardia [Articolo su rivista]
Padeletti, L; Pieragnoli, P; Ciapetti, C; Colella, A; Musilli, N; Porciani, Mc; Ricci, R; Pignalberi, C; Santini, M; Puglisi, A; Azzolini, P; Spampinato, A; Martelli, M; Capucci, A; Boriani, Giuseppe; Botto, G; Proclemer, A.
abstract

Background New atrial pacing techniques and overdrive pacing algorithms have been introduced to prevent atrial fibrillation. This study was designed to test the hypotheses that (I) interatrial septum pacing (IASP) at the triangle of Koch would be more effective than right atrial appendage pacing (RAAP) in preventing paroxysmal atrial fibrillation (PAF) in patients with sinus bradycardia and (2) an algorithm (CAP) designed to achieve constant atrial capture would increase the efficacy of rate-responsive atrial pacing. Methods We studied 46 patients with PAF and sinus bradycardia implanted with a DDD(R) (Medtronic Thera) pacemaker. Twenty-four patients (6.0 +/- 10.1 PAF episodes/month within 3 months before study) were randomized to RAAP and 22 patients (5.4 +/- 7.1, not significant) to IASP. Within each arm 2 randomized crossover periods of CAP-OFF and CAP-ON function were programed. Results The PAF episodes per month significantly decreased in the RAAP (CAP-OFF: 2.1 +/- 4.2, P < .05; CAP-ON: 1.9 <plus/minus> 3.81 P < .05) and in the IASP group (CAP-OFF: 0.2 <plus/minus> 0.5, P < .05; CAP-ON: 0.2 0.5, P < .05). Values were significantly lower in the IASP group than in the RAAP group in both CAP-OFF (0.2 0.5 vs 2.1 4.2, P < .05) and CAP-ON (0.2 0.5 vs 1.9 <plus/minus> 3.8, P < .05) conditions. PAF burden was significantly lower in the IASP than in the RAAP group in CAP-OFF (47 <plus/minus> 84 min/d vs 140 +/- 217, P < .05) and in CAP-ON (41 <plus/minus> 72 vs 193 +/- 266, P < .05) conditions. No differences were observed within each arm in PAF burden between the 2 crossover CAP programing periods. Conclusions Rate-adaptive IASP at the triangle of Koch is more effective than RAAP in preventing PAF in patients with sinus bradycardia. In our sample of patients no additional clinical benefit is furnished by the CAP algorithm.

2001 - Transvenous low energy internal cardioversion for atrial fibrillation: A review of clinical applications and future developments [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Camanini, C; Luceri, Rm; Branzi, A.
abstract

Low energy internal atrial cardioversion can be performed by delivering biphasic shocks between transvenous catheters positioned within the cardiac chambers or great vessels. Delivery of shocks results in effective cardioversion at energies < 6-10 J and the procedure can be effective even when external cardioversion has failed. Shock induced discomfort varies from patient to patient, but the procedure can be usually performed without general anesthesia and eventually under mild sedation. Nevertheless, tolerability has to be improved by obtaining a substantial reduction in defibrillating thresholds. With regard to safety, delivery of shocks for defibrillating the atria implies a potential risk of inducing ventricular fibrillation; to minimize this risk, shock delivery must be synchronous to the QRS and should be avoided during rapid RR cycles (< 300 ms). Presently, transvenous low energy cardioversion is an investigational procedure, but a widening of indications is expected in the near future. The cost of the procedure, which remains invasive and requires a brief hospital stay must be balanced with the benefit of restoring sinus rhythm and the possibility of maintaining sinus rhythm for the medium- to long-term. Experimental and clinical investigations of low energy internal cardioversion have resulted in the development of devices for atrial defibrillation whose clinical role and cost-benefit ratio is currently under evaluation.

2000 - Benefits in projected pacemaker longevity and in pacing related costs conferred by automatic threshold tracking [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Branzi, A; Mininno, A; Sigliano, R.
abstract

The aim of this study was to calculate the battery current drain of different VVI-VVIR pulse generators, with and without automatic adjustment of stimulation output, from the same manufacturer, and obtain projections on pacemaker longevity and pacing related costs. Twenty-five patients who had received a VVIR pacemaker (Microny SR + 2425T) with Autocapture function, an algorithm able to provide automatic adaptation of device output coupled with continuously monitored capture threshold, were analyzed. Calculations of current drain and projections of device longevity were based on diagnostic data retrieved from device memory and on comparisons of multiple programmed settings of the same device (Microny SR + 2425T with Autocapture, Low Output [output = 2 x Autocapture threshold, but not less than 2.4 V] versus Standard Output [5 V]). In addition, devices with Autocapture but with different battery capacities (0.35 Ah and 0.79 Ah, Microny and Regency, respectively) were compared to a standard device (battery capacity = 0.78 Ah) at 2.5-V and 5-V output settings. According to a series of assumptions, Autocapture increased device longevity by 53% (Microny) and by 245% (Regency) over a 15-year follow-up with a consequent reduction in pacing related costs of 25% (Microny) and of 57% (Regency) compared to the standard settings of a VVIR device from the same manufacturer. In conclusion, pacing with constant adaptation of generator output coupled with continuous monitoring of stimulation thresh old has the potential to increase generator longevity and to reduce pacing related costs as compared to a standard device from the same manufacturer.

2000 - DDD and single-lead VDD pacing: Evaluation of atrial signal dynamic changes [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Bandini, A; Moracchini, Pv; Capucci, A; Sigliano, R; Mininno, A; Branzi, A.
abstract

Background: Single-lead VDD pacing systems are an alternative to conventional DDD pacemakers in patients with atrioventricular (AV) block and normal sinus function. Hypothesis: The aim of this study was to assess changes of P-wave amplitude occurring in dynamic conditions in two groups of patients with a single-lead VDD and with a DDD pacing system, respectively. Methods: Twenty-eight patients with second- or third-degree AV block and normal sinus function were enrolled prospectively into the study. Seventeen patients were implanted with a single-lead VDD pacing system and 11 with a DDD pacemaker. Patients were evaluated at 3 months tall patients) and at 6 months (26 patients) at supine and in dynamic conditions (postural changes, hyperventilation, and during exercise). Results: Mean P-wave values at supine were 1.92 +/- 1.10 mV at 3 months and 1.76 +/- 1.01 mV at 6 months for VDD systems, and 4.63 +/- 2.18 mV at 3 months and 4.58 +/- 2.80 mV at 6 months for DDD pacemakers. In dynamic conditions, P-wave amplitude changes compared with supine condition ranged between -74 and +226% in VDD, and between -53 and +138% in DDD; however P-wave amplitudes showed no significant changes compared with baseline. Moreover, changes in atrial signal amplitudes did not occur randomly, and in both systems P-wave amplitudes remained significantly correlated with supine values. Conclusions: A wide range of P-wave amplitude variations occurs in different postural conditions or during exercise, both with single-lead VDD and DDD pacing systems. However, with appropriate programming of atrial sensitivity based on supine values, constant atrial tracking can be maintained.

2000 - Efficacy of implantable cardioverter-defibrillators for the prevention of sudden death in patients with hypertrophic cardiomyopathy. [Articolo su rivista]
Maron, Bj; Shen, Wk; Link, Ms; Epstein, Ae; Almquist, Ak; Daubert, Jp; Bardy, Gh; Favale, S; Rea, Rf; Boriani, Giuseppe; Estes, Nam; Spirito, P.
abstract

Background: Hypertrophic cardiomyopathy is a genetic disease associated with a risk of ventricular tachyarrhythmias and sudden death, especially in young patients. Methods: We conducted a retrospective multicenter study of the efficacy of implantable cardioverter-defibrillators in preventing sudden death in 128 patients with hypertrophic cardiomyopathy who were judged to be at high risk for sudden death. Results: At the time of the implantation of the defibrillator, the patients were 8 to 82 years old (mean [+/-SD], 40+/-16), and 69 patients (54 percent) were less than 41 years old. The average follow-up period was 3.1 years. Defibrillators were activated appropriately in 29 patients (23 percent), by providing defibrillation shocks or antitachycardia pacing, with the restoration of sinus rhythm; the average age at the time of the intervention was 41 years. The rate of appropriate defibrillator discharge was 7 percent per year. A total of 32 patients (25 percent) had episodes of inappropriate discharges. In the group of 43 patients who received defibrillators for secondary prevention (after cardiac arrest or sustained ventricular tachycardia), the devices were activated appropriately in 19 patients (11 percent per year). Of 85 patients who had prophylactic implants because of risk factors (i.e., for primary prevention), 10 had appropriate interventions (5 percent per year). The interval between implantation and the first appropriate discharge was highly variable but was substantially prolonged (four to nine years) in six patients. In all 21 patients with stored electrographic data and appropriate interventions, the interventions were triggered by ventricular tachycardia or fibrillation. Conclusions: Ventricular tachycardia or fibrillation appears to be the principal mechanism of sudden death in patients with hypertrophic cardiomyopathy. In high-risk patients with hypertrophic cardiomyopathy, implantable defibrillators are highly effective in terminating such arrhythmias, indicating that these devices have a role in the primary and secondary prevention of sudden death. (N Engl J Med 2000;342:365-73.) (C)2000, Massachusetts Medical Society.

2000 - Evaluation of myocardial injury following repeated internal atrial shocks by monitoring serum cardiac troponin I levels [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Cervi, V; Bronzetti, G; Magagnoli, G; Zannoli, R; Branzi, A.
abstract

Electrical shocks delivered for atrial cardioversion (CV) may cause myocardial damage. The aim of this study was to assess the extent of myocardial injury caused by repeated intracardiac shocks delivered for low-energy internal atrial CV.

2000 - High defibrillation threshold at cardioverter defibrillator implantation under amiodarone treatment: Favorable effects of D,L-sotalol [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Frabetti, L; Maraschi, M; Branzi, A.
abstract

A 57-year-old man with primary dilated cardiomyopathy and obesity received an implantable cardioverter defibrillator because of recurrent, poorly tolerated ventricular tachycardia despite continuous treatment with amiodarone. When the device was implanted, assessment of the ability to defibrillate induced ventricular fibrillation showed high energy requirements, with a lack of conventional safety margin between energies effective at defibrillation testing and maximal device output. Treatment with oral amiodarone was withdrawn and substituted with oral sotalol. A repeat defibrillation test, performed 54 days after amiodarone withdrawal and during D,L-sotalol treatment, showed a reduction in defibrillation energy requirements. In view of this experience, replacement of amiodarone treatment with an alternate class Ill agent (D,L-sotalol or other agents, if available) can be considered as a possible option in case of high defibrillation threshold at the time of the implantation in a patient receiving continuous amiodarone treatment.

2000 - Internal atrial cardioversion in atrial fibrillation [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Camanini, C; Corazza, I; Martignani, C; Zannoli, R; Branzi, A.
abstract

N/A

2000 - Predictors of atrial defibrillation threshold in internal cardioversion [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Camanini, C; Bacchi, L; Zannoli, R; Luceri, R; Branzi, A.
abstract

This study examined the clinical, echocardiographic, and electrophysiological factors influencing the atrial defibrillation threshold (ADFT) in patients with chronic, persistent AF undergoing transvenous, low energy, atrial cardioversion. Twenty-two patients (age 57 +/- 15 years) with a mean AF duration of 7.8 +/- 7.1 months (range 2-32 months) underwent internal cardioversion with catheters placed in the right atrium and coronary sinus. Biphasic shocks (3/3 ms) were delivered in a step-up protocol. ADFT was defined as the lowest energy shock that converted AF to sinus rhythm. All patients were successfully cardioverted at a mean ADFT of 5.62 +/- 2.82 J (range 2.6-12.9 J). Fifteen variables, including clinical characteristics (age, body mass index, AF duration, etiology), echocardiographic measurements (atrial diameter and volumes, interdexes of ventricular performance), hemodynamic measurements, and mean atrial cycle during AF were analyzed as possible predictors of ADFT. in univariate regression analysis, AF duration, mean RR interval, and cardiac index correlated with ADFT. In multivariate regression analysis, AF duration remained as the only significant predictor of ADFT (B coefficient 0.311, P < 0.002; 95% confidence interval [CI] 0.194-0.427). AF duration was the most powerful predictor of ADFT. It should be considered when planning internal CV of AF to limit the number of shocks delivered. Furthermore, long intervals between AF onset and CV should be avoided.

2000 - Repolarization changes in a double-blind crossover study of dofetilide versus sotalol in the treatment of ventricular tachycardia [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; De Simone, N; Bacchi, L; Martignani, C; Bitonti, F; Zannoli, R; Butrous, G; Branzi, A.
abstract

The aim of this study was to determine whether a therapeutic response to Class III antiarrhythmic drugs is related to predictable changes in repolarization on the electrocardiogram (ECG). A group of 57 patients with ischemic heart disease and inducible ventricular tachycardia (VT) at electrophysiological study(EPS) were selected from a population enrolled in a randomized double-blind crossover study of dofetilide (500 mug bid) versus sotalol (160 mg bid). ECGs were analyzed blindly, and RR, QT (maximum value/12 leads), QTc (Bazett's formula), QT dispersion (QTmax - QTmin over 12 leads) and QTc dispersion, were calculated at baseline and on the third day of treatment (4 hours after dosing), when patients underwent EPS to test the effects of study drugs on VT inducibility. Results: At EPS 21 patients were responders to dofetilide and 22 to sotalol. On day 3, a significant increase in QT and QTc and decrease in QT and QTc dispersion, compared to baseline, was measured in responders and nonresponders, with both dofetilide and sotalol. No significant difference in QTc or QT dispersion between responders and nonresponders Mras observed in either treatment group. In conclusion, treatment with dofetilide and sotalol was associated with an increase in QT and QTc, and a decrease in QT and QTc dispersion. In contrast with previous reports, a differential effect on QT or QTc dispersion was not observed in drug responders versus nonresponders.

1999 - Antiarrhythmic benefits of dual chamber stimulation with rate-response in patients with paroxysmal atrial fibrillation and chronotropic incompetence - A prospective, multicentre study [Articolo su rivista]
Bellocci, F; Spampinato, A; Ricci, R; Puglisi, A; Capucci, A; Dini, P; Boriani, Giuseppe; Botto, G; Curnis, A; Moracchini, Pv; Nicotra, G; Lisi, F; Nigro, P.
abstract

Background While the haemodynamic benefits of DDDR pacing compared with DDD pacing in patients with brady-tachy syndrome and chronotropic incompetence (CI) are well demonstrated, the antiarrhythmic advantage is controversial and so far not dearly demonstrated. Aim We have performed a prospective, randomized, multicentre study to evaluate the efficacy of DDDR and DDD pacing modes in preventing paroxysmal atrial fibrillation (PAF) episodes in patients with brady-tachy syndrome and CI. Methods and Results Seventy-eight patients were included in the study. All patients had a dual chamber pacemaker implanted and were randomly programmed to DDD or DDDR with a cross over (DDD--> DDDR or vice versa) at 3 months. The final evaluation was performed at 6 months by means of two self-administered symptom questionnaires to evaluate activity. Symptoms of palpitations were analysed and scored. The patients were less symptomatic with the DDDR mode. The number of mode-switch activations compared with symptomatic episodes of PAF confirmed the high rate of asymptomatic PAF episodes in patients with brady-tachy syndrome. We conclude that in a small but well defined population of patients affected by sick sinus syndrome with CI and severely symptomatic PAF, DDDR pacing compared with DDD pacing may offer an additional antiarrhythmic benefit and should be considered the primary mode of pacing. (C) 1999 The European Society of Cardiology.

1999 - Electrophysiological effects of flecainide and propafenone on atrial fibrillation cycle and relation with arrhythmia termination [Articolo su rivista]
Biffi, M; Boriani, Giuseppe; Bronzetti, G; Capucci, A; Branzi, A; Magnani, B.
abstract

Objectives-(1) To investigate the electrophysiological effects of flecainide and propafenone during atrial fibrillation, and their relation to arrhythmia termination; (2) to investigate the effects of isoprenaline on atrial fibrillation in basal conditions and during treatment with class 1C drugs to evaluate the role of adrenergic stimulation on proarrhythmic events occurring during this treatment. Design-Prospective, single centre study. Setting-University hospital. Methods-10 patients with lone paroxysmal atrial fibrillation underwent an electrophysiological study. The dynamic behaviour of MFF (the mean of 100 consecutive atrial fibrillation intervals) was evaluated at two atrial sites after induction of atrial fibrillation either at baseline or after class 1C drug administration (flecainide or propafenone 2 mg/kg). The effects of isoprenaline on MFF and RR interval were also investigated both under basal conditions and during class 1C drug treatment. Results-After induction of atrial fibrillation, mean (SD) MFF shortened with time, and was further shortened by isoprenaline infusion (177 (22) v 162 (16) v 144 (11) ms, p < 0.05). The administration of class 1C drugs reversed this trend and significantly increased the MFF to an average of 295 (49) ms, leading to conversion to sinus rhythm within 10 minutes in all patients. Atrial fibrillation was then reinduced on class 1C drugs: isoprenaline shortened the MFF and RR interval with a trend to AV synchronisation (223 (43) v 269 (49) ms for the MFF, 347 (55) v 509 (92) ms for the RR, p < 0.05); 1:1 sustained AV conduction occurred in two patients, at 187 and 222 beats/min respectively. One of these patients underwent electrical cardioversion because of haemodynamic collapse. Conclusions-Class 1C drugs are effective at restoring sinus rhythm by increasing the MFF to a much greater extent than observed in self terminating atrial fibrillation episodes, and reversing the spontaneous atrial fibrillation behaviour (progressive shortening of MFF and self perpetuation of atrial fibrillation). MFF prolongation with 1:1 conduction at fast ventricular rates may lead to synchronisation during adrenergic stimulation, with a very short ventricular cycle; hence it is advisable to keep the patients at rest after acute class 1C drug loading or to consider pharmacological modulation of AV conduction for patients who are prone to a fast ventricular response.

1999 - Evaluation of atrial refractoriness and atrial fibrillation inducibility immediately after internal cardioversion in patients with chronic persistent atrial fibrillation [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Zannoli, R; Branzi, A; Magnani, B.
abstract

To prospectively evaluate right atrial refractoriness and sustained atrial fibrillation (AF) inducibility at programmed electrical stimulation in two groups of patient: a series of patients with chronic persistent AF, studied immediately after successful low energy internal atrial cardioversion, and a group of control patients without history of supraventricular arrhythmias.

1999 - Favorable effects of flecainide in transvenous internal cardioversion of atrial fibrillation [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Capucci, A; Bronzetti, G; Ayers, Gm; Zannoli, R; Branzi, A; Magnani, B.
abstract

OBJECTIVES The aim of the study was to evaluate the effects of intravenous (IV) flecainide on defibrillation energy requirements in patients treated with low-energy internal atrial cardioversion. BACKGROUND Internal cardioversion of atrial fibrillation is becoming a more widely accepted therapy for acute episode termination and for implantable atrial defibrillators. METHODS Twenty-four patients with atrial fibrillation (19 persistent, 5 paroxysmal) underwent elective transvenous cardioversion according to a step-up protocol. After successful conversion in a drug-free stale, atrial fibrillation was induced by atrial pacing; IV flecainide (2 mg/kg) was administered and a second threshold was determined. In patients in whom cardioversion in a drug-free state failed notwithstanding a 400- to 550-V shock, a threshold determination was attempted after flecainide. RESULTS Chronic persistent atrial fibrillation was converted in 13/19 (68%) patients at baseline and in 16/19 (84%) patients after flecainide. Paroxysmal atrial fibrillation was successfully cardioverted in all the patients. A favorable effect of flecainide was observed either in chronic persistent atrial fibrillation (13 patients) or in paroxysmal atrial fibrillation (5 patients) with significant reductions in energy requirements for effective defibrillation (persistent atrial fibrillation: 4.42 +/- 1.37 to 3.50 +/- 1.51 J, p < 0.005; paroxysmal atrial fibrillation: 1.68 +/- 0.29 to 0.84 +/- 0.26 J, p < 0.01). In 14 patients not requiring sedation, the favorable effects of flecainide on defibrillation threshold resulted in a significant reduction in the scores of shock-induced discomfort (3.71 +/- 0.83 vs. 4.29 +/- 0.61, p < 0.005). No ventricular proarrhythmia was observed for any shock. CONCLUSIONS Intravenous flecainide reduces atrial defibrillation threshold in patients treated with low-energy internal atrial cardioversion. This reduction in threshold results in lower shock-induced discomfort. Additionally, flecainide may increase the procedure success rate in patients with chronic persistent atrial-fibrillation. (C) 1999 by the American College of Cardiology.

1999 - Low energy internal atrial cardioversion in atrial fibrillation lasting more than a year [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Pergolini, F; Zannoli, R; Branzi, A; Magnani, B.
abstract

The aim of this study was to evaluate the efficacy of low energy internal atrial cardioversion in restoring sin us rhythm (SR) in patients with chronic atrial fibrillation (AF) persisting > 1 year. Fifteen patients with chronic AF lasting > 1 year (from 13-48 months, mean 24 +/- 13 months) were studied. R wave synchronized 3/3 ms biphasic shocks were delivered between right atrial and coronary sinus (left pulmonary artery in five patients) electrodes. Sedatives or anesthetics were administered only at the patient's request. Results: Stable SR was restored in 14 (93%) of 15 patients after shocks with a mean leading edge voltage of 377 +/- 77 V (range 260-500) and a mean delivered energy of 7.3 +/- 3.4 J (range 2.6-12.9). The procedure was performed without anesthesia in 6 (40%) patients. All successfully cardioverted patients were treated with flecainide, sotalol, or amiodarone. During a follow up of 7.7 +/- 7.9 months (range 1-24) AF recurred in five (36%) patients. Three of five AF recurrences occurred within 3 days after conversion to SR. Conclusion: internal low energy atrial cardioversion is highly effective in restoring SR even in patients with AF lasting > 1 year. The long-term results from the standpoint of freedom from AF recurrences, are satisfactory, although additional antiarrhythmic treatment is required, particularly in the first days after conversion.

1999 - Transvenous internal cardioversion for atrial fibrillation: a randomized study on defibrillation threshold and tolerability of asymmetrical compared with symmetrical shocks [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Zannoli, R; Branzi, A; Magnani, B.
abstract

The aim of the study was to compare, according to a randomized cross-over design, two different biphasic waveforms (6.5/2.5 ms and 3.0/3.0 ms phases duration, respectively) for low energy internal atrial cardioversion with regard to energy requirements for cardioversion and shock induced discomfort. Methods: Nineteen patients with chronic persistent atrial fibrillation (AF)(mean duration 16+/-20 months) were submitted to internal atrial cardioversion (shock delivery between catheters in right atrium and coronary sinus, respectively) and were randomly allocated to baseline cardioversion with an asymmetrical biphasic shock (6.5/2.5 ms) or with a symmetrical biphasic shock (3.0/3.0 ms), according to a step up protocol. After baseline cardioversion, a sustained AF was reinduced and the patients crossed to the alternative waveform. The procedure was performed without routine administration of sedatives and shock induced discomfort was monitored by a subjective score (1 to 5). Sedatives or anesthetics were administered at patient's request. Results: The procedure was effective in all the patients and was performed without need for sedatives/anesthetics in 17/19 patients (89%). Leading edge voltage of effective shocks resulted lower for asymmetrical shocks compared to symmetrical shocks (290+/-76 vs. 337+/-104 V, P<0.001) with no statistically significant differences in delivered energy (7.74+/-4.25 vs. 8.65+/-5.94 J). Moreover shock induced discomfort resulted lower for asymmetrical shocks compared to symmetrical (pain score=4.18+/-0.73 vs. 4.59+/-0.62, P<0.02). Shock impedence of effective shocks was 59+/-10 ohms for both waveforms. No significant complications occurred during the procedure and no ventricular arrhythmia was observed after atrial cardioversion. Transient bradycardia requiring support ventricular pacing was observed in one patient. Conclusions: Delivery of biphasic asymmetrical shocks (6.5/2.5 ms) results in lower leading edge voltage of effective shocks and better patients tolerability compared with conventional biphasic symmetrical shocks (3.0/3.0 ms). These findings are of interest both for transvenous internal cardioversion of chronic persistent AF and for implantable atrial defibrillators. (C) 1999 Elsevier Science Ireland Ltd. All rights reserved.

1998 - Cardioverter-defibrillator oversensing due to double counting of ventricular tachycardia electrograms [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Frabetti, L; Parlapiano, M; Galli, R; Branzi, A; Magnani, B.
abstract

We report a case of a patient with idiopathic dilated cardiomyopathy and recurrent ventricular tachycardias refractory to antiarrhythmic treatment with amiodarone, A cardioverter defibrillator implantation was performed by the transvenous technique, but ventricular tachycardia detection resulted to be inappropriate because of constant double sensing of ventricular tachycardia electrograms (QRS width=250 ms). Device programmability didn't allow a satisfactory solution to this problem, therefore a more appropriate sensing system was considered. Through an anterior thoracotomy two epicardial wires were positioned acid sensing by these wires, placed closer to ventricular tachycardia origin, resulted appropriate. An electrophysiologic study and subsequent follow up confirmed appropriate ICD detection of ventricular tachycardias. This case emphasizes how in some cases sensing by epicardial wires may be a solution for QRS double counting occurring with endocardial leads during ventricular tachycardia. (C) 1998 Elsevier Science Ireland Ltd. All rights reserved.

1998 - Clinical experience with downsized lower energy output implantable cardioverter defibrillators. Ventak Mini II Clinical Investigators [Articolo su rivista]
Boriani, G; Frabetti, L; Biffi, M; Sallusti, L
abstract

Technical improvements in cardioverter defibrillators technology has resulted in decrease in can size coupled with improved electrodes technology. A decrease in maximum energy output allows further decrease in device size. The aim of this study was to evaluate the feasibility of a single lead transvenous implant employing a downsized cardioverter-defibrillator (volume 59 cm3), with a related decrease in maximum energy output (29-31 joules as stored energy and 25-27 joules as delivered energy).

1998 - Clinical pattern and complications of nonvalvular atrial fibrillation in elderly and nonelderly patients [Articolo su rivista]
Boriani, Giuseppe; Gallina, M; Biffi, M; Bronzetti, G; Manetti, R; De Simone, N; Branzi, A; Magnani, B.
abstract

Three hundred patients with nonvalvular atrial fibrillation were hospitalized between 1988 and 1995, representing 2% of hospital admissions in this period. Two hundred six patients had paroxysmal atrial fibrillation, associated with structural heart disease in 67% of the cases (patients' age greater than or equal to 65 years in 60%) and not associated with heart disease in 33% (patients' age greater than or equal to 65 years in 36%). Ninety-four patients had chronic atrial fibrillation, associated with structural heart disease in 79% of the cases (patients' age greater than or equal to 65 years in 51%) and not associated with structural heart disease in 21% (patients' age greater than or equal to 65 years in 40%). In patients with paroxysmal atrial fibrillation, the most common underlying heart disease was ischemic heart disease, either in patients <65 years (prevalence = 49%) or greater than or equal to 65 years (prevalence = 82%). In patients aged <65 years with chronic atrial fibrillation, the most common underlying heart disease was cardiomyopathy (prevalence = 44%), whereas in patients aged greater than or equal to 65 years, the most common heart disease was ischemic heart disease (prevalence = 42%). Among patients aged <65 years, systemic hypertension was present in 20% of the patients with paroxysmal atrial fibrillation without structural heart disease, in 41% of patients with paroxysmal atrial fibrillation and heart disease, in 50% of patients with chronic atrial fibrillation without structural heart disease, and in 42% of patients with chronic atrial fibrillation and heart disease. Among patients aged greater than or equal to 65 years, systemic hypertension was present in 60% of the patients with paroxysmal atrial fibrillation without structural heart disease, in 52% of patients with paroxysmal atrial fibrillation and heart disease, in 63% of patients with chronic atrial fibrillation without structural heart disease, and in 53% of patients with chronic atrial fibrillation and heart disease. Overall 32 out of 300 patients (11%) had a history of previous thromboembolic complications (transient ischemic attacks in 50%, stroke in 44%, systemic embolism in 6%), and these complications occurred even in patients without structural heart disease (2% of patients with paroxysmal atrial fibrillation <65 years, 8% of patients with paroxysmal atrial fibrillation greater than or equal to 65 years, 8% of patients with chronic atrial fibrillation <65 years, and 50% of patients with chronic atrial fibrillation greater than or equal to 65 years). In conclusion, in a selected in-hospital population, nonvalvular atrial fibrillation (either paroxysmal or chronic) is more frequently associated with structural heart disease, particularly ischemic heart disease. Hypertension is quite common in these patients, especially in those aged greater than or equal to 65 years. Thromhoembolic complications may occur even in atrial fibrillation without structural heart disease, and their prevalence is particularly high in elderly subjects with chronic atrial fibrillation.

1998 - Clinical reliability of single-lead VDD pacing from evaluation of P-wave sensing under dynamic conditions [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Bandini, A; Pettini, A; Moracchini, Pv; Giuliani, M; Capucci, A; Groppi, F; Sigliano, R; Mininno, A.
abstract

In a group of 20 patients implanted with a single-lead VDD pacing system, a wide interindividual variability was found in P-wave amplitude changes occurring under dynamic conditions, even though they were of minor clinical relevance because constant atrial tracking was maintained.

1998 - Conversion of recent-onset atrial fibrillation to sinus rhythm: Effects of different drug protocols [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Capucci, A; Botto, G; Broffoni, T; Ongari, M; Trisolino, G; Rubino, I; Sanguinetti, M; Branzi, A; Magnani, B.
abstract

In a population of 417 hospitalized patients, the efficacy and safety of different drug regimens administered to convert atrial fibrillation (AF) of recent onset (less than or equal to 7 days duration) to sinus rhythm were evaluated. All patients were in NYHA Class less than or equal to 2, and free of heart failure. They were randomly allocated to treatment with placebo in 221 patients; TV amiodarone, 5 mg/kg bolus, followed by 2.8 g/24 hours in 51 patients; IV propafenone, 2 mg/kg bolus, followed by 0.0078 mg/kg/min in 57 patients; p.o. propafenone, 600 mg p.o. in a single dose in 119 patients; and p.o. flecainide, 300 mg p.o. in (7 single dose in 69 patients. All patients were continuously monitored by Holter EGG, and the number of conversions to sinus rhythm was measured at 1, 3, and 8 hours. Results: (1) IV propafenone resulted in a higher conversion rate within 2 hour compared with the oral loading regimens of propafenone or flecainide, but the conversion rates at 3 and 8 hours were comparable, approximately 75% at 8 hours; 2) IV amiodarone was not different from placebo until 8 hours when it was associated with 57% of conversions; (3) conversion to sinus rhythm at 8 hours was observed in 37% of the placebo treated patients. Serious adverse effects occurred in few patients: two patients treated with flecainide and one treated with IV propafenone experienced left ventricular decompensation; one patient treated with placebo and two treated with flecainide had atrial flutter with rapid ventricular response. In conclusion, single-dose, oral loading with propafenone or flecainide are acceptable alternatives to conventional drug regimens in selected hospitalized patients. In addition, the measure of a placebo effect is mandatory in studies of recent-onset AF.

1998 - Efficacy and tolerability in fully conscious patients of transvenous low-energy internal atrial cardioversion for atrial fibrillation [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Bronzetti, G; Ayers, Gm; Zannoli, R; Branzi, A; Capucci, A; Magnani, B.
abstract

Transvenous low-energy atrial cardioversion was performed in a series of fully conscious patients (30 patients with chronic atrial fibrillation and 5 patients with paroxysmal atrial fibrillation). The results show that internal atrial defibrillation is effective and tolerable in most patients.

1998 - Le aritmie in età pediatrica [Articolo su rivista]
Picchio, F. M.; Bronzetti, G.; Boriani, G.
abstract

N/A

1998 - Malignant vasovagal syncope: a randomised trial of metoprolol and clonidine - Reply [Articolo su rivista]
Biffi, M; Boriani, Giuseppe; Sabbatani, P; Bronzetti, G; Frabetti, L; Zannoli, R.
abstract

N/A

1998 - Oral loading with propafenone: A placebo-controlled study in elderly and nonelderly patients with recent onset atrial fibrillation [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Capucci, A; Botto, Gl; Broffoni, T; Rubino, I; Della Casa, S; Sanguinetti, M; Branzi, A; Magnani, B.
abstract

The efficacy and safety of propafenone as an oral loading dose (600-mg single oral dose) in converting recent-onset atrial fibrillation (less than or equal to 7 days duration) to sinus rhythm were evaluated in a single-blind, placebo-controlled study according to patients' age. Overall, 240 hospitalized patients, NYHA Class less than or equal to 2 without signs or symptoms of heart failure were enrolled: among patients aged less than or equal to 60 years, 55 were allocated to propafenone treatment and 59 to placebo, respectively, and among patients aged > 60 years, 64 were allocated to propafenone treatment and 62 to placebo, respectively. Results: In each age group, the likelihood of conversion to sinus rhythm was significantly greater after propafenone compared with placebo at 3 and 8 hours. For patients aged less than or equal to 60 years, corresponding odd ratios were 3.78 (95% CI = 1.80-7.92, P = 0.04) at 3 hours and 4.74 (95% CI = 2.22-10.54, P = 0.02) at 8 hours; for patients aged > 60 years odd ratios were 5.03 (95% CI = 2.08-12.12, P = 0.02) at 3 hours and 6.75 (95% CI = 3.28-73.86, P = 0.01) at 8 hours, respectively. Logistic regression analysis showed that conversion to sinus rhythm within 3 hours was predicted by age less than or equal to 60 years IP = 0.0064) and by propafenone treatment IP ( 0.0001), and conversion to sinus rhythm within 8 hours was predicted by age less than or equal to 60 years(P = 0.0467) and by propafenone treatment (P ( 0.0001). The occurrence of adverse effects was observed in 14%-16% of propafenone treated patients and in 8% of placebo treated patients without significant differences according to age. In conclusion, in patients with recent-onset atrial fibrillation without signs of heart failure, propafenone as a single oral loading dose is effective. It is also effective in selected elderly subjects with a favorable safety profile. Moreover, spontaneous conversion to sin us rhythm appears to occur less frequently in elderly patients.

1998 - Pharmacological treatment of atrial fibrillation: a review on prevention of recurrences and control of ventricular response [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Branzi, A; Magnani, B.
abstract

Atrial fibrillation is the most common sustained arrhythmia, however its treatment remains controversial and problematic. Electrical or pharmacological cardioversion are able to restore sinus rhythm in many patients but maintenance of sinus rhythm requires long term treatment with antiarrrhythmic agents. Today there is major concern regarding the ventricular proarrhythmic effects of antiarrhythmic drugs because they may increase mortality. Even non-cardiac toxicity of these agents must be considered. An alternative strategy based on pharmacological control of ventricular response rate coupled with antithromboembolic prophylaxis can be followed. For rate control digoxin alone has some specific limitations, therefore, use of calcium antagonists (verapamil or diltiazem) or beta-blockers must be considered. At the present time, the relative efficacy and risks of these two alternative strategies in specific patients subgroups remain to be established. Today, non-pharmacological treatments, as atrio-ventricular node ablation are also available. In elderly patients, moreover, advanced age, underlying heart disease, concomitant systemic illnesses and patient compliance to treatments condition our decision making and treatment needs to be individualized. Appropriate knowledge of the advantages, of the limitations and of the costs of every pharmacological or non-pharmacological treatment option is required for deciding in every patient in view of the best risk-benefit and cost-benefit ratio. (C) 1998 Elsevier Science ireland Ltd. All rights reserved.

1997 - Beta-blocker treatment guided by head-up tilt test in neurally mediated syncope [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Bronzetti, G; Sabbatani, P; Branzi, A; Magnani, B.
abstract

This study was an open-label, uncontrolled, dose-escalation trial of beta-blockers in patients with a history of syncope without warning or syncope resulting in trauma (malignant vasovagal syncope) who had positive head-up tilt test (HUT) responses, with or without isoproterenol infusion. Thirty patients (mean age, 37 +/- 21 years) with recurrent syncopal and near-syncopal episodes of unexplained origin in the previous year (6 +/- 14 syncopal episodes and 17 +/- 3 near-syncopes) underwent HUT for diagnostic purposes and for guiding prophylactic treatment. After patients were given a 10-minute rest in a recumbent position, rye performed an WT at 70 degrees for 25 minutes; if indicated, isoproterenol testing was performed at incremental dosages (dye steps at 10-minute intervals at 80 degrees), AU patients experienced syncope during HUT, 15 (50%) at baseline HUT and 15 (50%) during isoproterenol infusion (1 to 3 mu g/min; mean, 1.6 mu g/min). Sixteen syncopes were of vasodepressor type, 10 were mixed, and 4 were of cardioinhibitory type. After baseline HUT, betablocking drugs were prescribed to all patients as follows: 1 patient was given propranolol (160 mg daily), and 29 patients were given metoprolol (246 +/- 49 mg daily), with a dose titration period of 14 days. HUT was repeated after 3 weeks, and 24 patients (80%) had negative results (no syncope or anomalous responses). After further dosage adjustment of beta-blockers in nonresponders, a negative HUT was obtained in 28 patients (93%). Overall mean metoprolol daily dose was 262 +/- 60 mg (29 patients), and propranolol was administered at 160 mg daily in 1 patient. Thirteen patients (43%) reported side effects, none of which required drug withdrawal. At an average follow-up of 16 +/- 4 months, none of the patients experienced syncope, a statistically significant reduction. Moreover, a statistically significant reduction in the number of near-syncopal episodes was observed in comparison to the previous year. None of the patients discontinued treatment because of long-term side effects. Beta-blockers were well tolerated and achieved a high rate of efficacy, even in cardioinhibitory syncopes. In conclusion, in selected patients with malignant vasovagal syncope, treatment with metoprolol or propranolol at relatively high doses is feasible and, if guided by HUT results, is associated with a favorable outcome in terms of freedom from syncopal recurrences. Appropriate titration to achieve the full beta-blocking effect appears to be advisable.

1997 - Conversion of recent onset atrial fibrillation to sinus rhythm using a single oral loading dose of propafenone: comparison of two regimens [Articolo su rivista]
Botto, Gl; Capucci, A; Bonini, W; Boriani, Giuseppe; Broffoni, T; Barone, P; Espureo, M; Lombardi, R; Molteni, S; Ferrari, G.
abstract

A population of 105 patients with recent onset (<72 h) atrial fibrillation was randomly treated with propafenone as a single oral loading dose of 450 mg (Regimen A) or 600 mg (Regimen B) or with placebo. A 24-h Holter was performed. Criteria of efficacy were conversion to sinus rhythm at 2, 4 and 8 h compared to placebo and also significant reduction of mean ventricular rate in persistent atrial fibrillation. After 2 h, regimen B was more effective than either regimen A (43% vs. 8%; p=0.001) or placebo (11%; p=0.004). At 4 h, both the active treatments were more effective than placebo (17% vs. 46% regimen A and 57% vs. regimen B; p<0.04 and p<0.001, respectively). Sinus rhythm resumed within 24 h in 71%, 80% and 69% of the patients with regimen A, B and placebo, respectively (p=not significant): The mean ventricular rate reduction after 1 h was 8%, 11% and 4% for regimen A, B and placebo, respectively (p<0.005 vs. regimen B), and 17%, 25% and 6% respectively (p<0.001 placebo vs. regimen A and B, p<0.05 regimen B vs. A) at 2 h. No major adverse effect occurred. Atrial flutter with 1:1 atrioventricular conduction ensued only in one case who received placebo. Propafenone acute oral administration is more effective than placebo in rapidly converting recent-onset atrial fibrillation to sinus rhythm and may be the treatment of choice in this setting limiting hospitalization and contributing to improved quality of life. Copyright (C) 1997 Elsevier Science Ireland Ltd.

1997 - Lead related complications in transvenous cardioverter-defibrillators: Clinical presentation and options for reinstituting lead system reliability [Articolo su rivista]
Boriani, G.; Frabetti, L.; Galli, R.; Parlapiano, M.; Biffi, M.; Sabbatani, P.; Bronzetti, G.; Capucci, A.; Pierangeli, A.; Magnani, B.
abstract

N/A

1997 - Malignant vasovagal syncope: A randomised trial of metoprolol and clonidine [Articolo su rivista]
Biffi, M; Boriani, Giuseppe; Sabbatani, P; Bronzetti, G; Frabetti, L; Zannoli, R; Branzi, A; Magnani, B.
abstract

Objective-To evaluate the efficacy of head up tilt guided treatment with metoprolol and clonidine in preventing the recurrence of syncope in patients with malignant vasovagal syncope. Patients-20 patients (9 men and 11 women, mean age 33 (SD 17), range 14 to 62 years) with severe symptoms. Design-Randomised double blind cross-over trial; efficacy was assessed by head up tilt testing. Results-Metoprolol was more effective than clonidine in abolishing syncope (19/20 v 1/20, P < 0.001) but clonidine showed some beneficial effects on time to syncope and severity of hypotension in 12 patients. During an average follow up of 15 (3) months there was a significant reduction in the recurrence of symptoms compared with the previous year in patients who had tilt up guided treatment (18 metoprolol, 1 clonidine). Conclusions-Treatment guided by head up tilting is a reliable method of treating patients with malignant vasovagal syndrome. Metoprolol was an effective long term treatment for preventing syncope. High doses were more effective and a careful dose titration period helped to minimise withdrawal symptoms and side effects.

1997 - Oral propafenone to convert recent-onset atrial fibrillation in patients with and without underlying heart disease - A randomized, controlled trial [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Capucci, A; Botto, Gl; Broffoni, T; Rubino, I; Dellacasa, S; Sanguinetti, M; Magnani, B.
abstract

Background: The effectiveness of oral propafenone in converting recent-onset atrial fibrillation to sinus rhythm has been established by controlled trials. However, it is not clear whether the effectiveness of propafenone is affected by the presence or absence of underlying heart disease. Objectives: To investigate the safety and effectiveness of oral propafenone and the role of underlying heart disease. Design: Randomized, single-blind, controlled study. Setting: 3 teaching hospitals. Patients: 240 hospitalized patients with recent-onset atrial fibrillation. Intervention: Propafenone (one 600-mg oral dose) or placebo. Measurements: Conversion rates at 3 and 8 hours. Results: Propafenone was more effective than placebo for converting atrial fibrillation to sinus rhythm at 3 hours: Fifty-four of 119 patients (45%) receiving propafenone and 22 of 121 patients (18%) receiving placebo had conversion (P < 0.001). It was also more effective at 8 hours: Ninety-one of 119 patients (76%) receiving propafenone and 45 of 121 patients (37%) receiving placebo had con version (P < 0.001). Subgroup analysis showed that among patients without heart disease, 78% of those receiving propafenone and 56% of those receiving placebo converted to sinus rhythm within 8 hours (P = 0.02). In those with hypertension, the rate was 70% for those receiving propafenone and 27% for those receiving placebo (P < 0.001); in patients with structural heart disease, the rate was 81% for those receiving propafenone and 17% for those receiving placebo (P < 0.001). Conclusions: Oral loading of propafenone was more effective than placebo for conversion to sinus rhythm with in 8 hours and had a favorable safety profile. The rate of spontaneous conversion to sinus rhythm was higher in patients without structural heart disease; this finding has important implications for the assessment of drug effectiveness in recent-onset atrial fibrillation.

1997 - Paroxysmal atrial fibrillation in sleep [Articolo su rivista]
Coccagna, G; Capucci, A; Bauleo, S; Boriani, Giuseppe; Santarelli, A.
abstract

Thirty-eight patients with lone paroxysmal atrial fibrillation (PAF) were monitored during spontaneous sleep. The starts of 111 episodes of atrial fibrillation (AF) occurred in 12 patients. Statistical analysis failed to disclose significant differences in the number of starts per hour between wakefulness and the different sleep stages. Heart rate (HR) in the 60 seconds prior to a PAF episode did not show significant changes with respect to fragments of recording taken away from PAF episodes. As expected, spectral analysis of HR variability during sleep (basal values) showed a reduction of low frequency/high frequency (LF/HF) ratio during slow sleep, while the ratio returned to values similar to wake levels during REM sleep. In the 2 minutes preceding a PAF episode the LF/HF ratio of the spectral power was more unstable with a clear-cut prevalence of sympathetic activity both in wake and in different sleep stages. A shift toward parasympathetic activation was never seen before the start of any of the 17 PAF episodes recorded during sleep.

1996 - La fibrillazione atriale [Monografia/Trattato scientifico]
Capucci, A; Boriani, Giuseppe
abstract

N/A

1996 - Role of magnetic resonance in the diagnosis of arrhythmogenic right ventricular dysplasia [Contributo diagnostico della risonanza magnetica nel sospetto clinico di displasia aritmogena del ventricolo destro] [Articolo su rivista]
Fattori, R.; Castriota, F.; Bertaccini, P.; Celletti, F.; Boriani, G.; Sangiorgio, P.; Gavelli, G.
abstract

N/A

1996 - Ventricular fibrillation after intravenous amiodarone in Wolff-Parkinson-White syndrome with atrial fibrillation [Articolo su rivista]
Boriani, Giuseppe; Biffi, M; Frabetti, L; Azzolini, U; Sabbatani, P; Bronzetti, G; Capucci, A; Magnani, B.
abstract

N/A

1995 - AGE-DEPENDENCE OF FLECAINIDE PHARMACOKINETICS [Articolo su rivista]
Boriani, Giuseppe; Capucci, A; Strocchi, E; Spedicato, L; Biffi, M; Calliva, R; Magnani, B.
abstract

Aim: The aim of the study was to evaluate the relationship between age and the pharmacokinetics of flecainide. Methods: Fifteen patients with frequent premature ventricular contractions and with normal renal function were selected and divided into two groups: elderly (greater than or equal to 60 years) and younger patients (< 60 years). Flecainide pharmacokinetics were studied either after acute oral administration (200 mg) of the drug or at the end of a 21-day course (150 mg twice daily). Results: In elderly patients, the plasma half-life of flecainide after chronic treatment was significantly longer than that after acute oral administration (22.1 +/- 4.3 compared with 12.1 +/- 2.3 h, P< 0.001; mean half-life 84% longer after chronic administration). In the younger patients, the half-lives of flecainide after acute and chronic treatment were not significantly different (11.2 +/- 2.9 compared with 13.9 +/- 3.2h). In both groups, the area under the concentration-time curve (AUC) after drug administration increased during chronic treatment (P<0.001 in both cases), although the change was proportionally greater in the elderly group (an increase of 139% compared with 76% in the other group). After both acute and chronic treatment with flecainide, the AUC was higher in the elderly than in the younger patients (P< 0.05 for acute and P< 0.005 for chronic treatment, respectively). The half-life of flecainide during chronic treatment and the observed percentage increases in AUC during chronic treatment were significantly related to the age of the patient (r = 0.73, P< 0.005 and r= 0.66, P<0.01, respectively). Conclusion: Flecainide kinetics are strictly dependent on the age of the patient; in elderly people, even in those with normal renal function, the drug exhibits non-linear kinetics. In clinical practice, when treating patients over the age of 60 years with flecainide, the initial dosage should be reduced and monitoring of the plasma concentration of the drug should be considered.

1995 - Cardioverter-defibrillatori impiantati per via transvenosa: esperienza clinica all'impianto e durante il follow-up [Transvenous cardioverter-defibrillators: clinical experience at implantation and follow-up] [Articolo su rivista]
Boriani, G.; Frabetti, L.; Capucci, A.; Parlapiano, M.; Biffi, M.; Sabbatani, P.; Spedicato, L.; Bronzetti, G.; Pierangeli, A.; Galli, R
abstract

Thirty-seven patients with ventricular tachyarrhythmias refractory to antiarrhythmic drug treatment, guided by electrophysiological testing, were submitted to implantation of a cardioverter-defibrillator by the transvenous technique. Mean age was 55 +/- 14 years and the underlying heart disease was coronary heart disease in 24 patients, cardiomyopathy or other etiologies in 11 patients. In 2 patients ventricular arrhythmias were idiopathic. Left ventricular ejection fraction was &lt; or equal to 40% in 65% of the patients. The following devices were implanted: CPI Ventak P in 2 patients, Ventak P2 in 9 patients, Ventak PRx in 9 patients, Ventak PRxII in 2 patients, Telectronics Guardian ATP III 4215 in 9 patients, Siemens Siecure in 5 patients, Medtronic Jewel PCD in 1 patient. At implantation defibrillation threshold was lower with biphasic shocks than with monophasic shocks (17.0 +/- 3.2 vs 20.9 +/- 3.8 J, p &lt; 0.003) and the need for subcutaneous patches was lower when biphasic shocks were employed. Operative and perioperative mortality were 0% and no significant complications were observed. During the follow-up (16 +/- 11 months) 35% of the patients had appropriate shocks and 93% of the patients with antitachycardia pacing availability (n = 15) had effective antitachycardia pacing interventions. The following complications were observed: lead failure in 4 patients (3 insulation breaks and 1 elongation for stretching), late lead dislodgement in 2 patients, lead recall in 1 patient, all of which required reintervention. Inappropriate shocks occurred in 30% of the patients and were related to lead failure, supraventricular arrhythmias or alternating current interference. During the follow-up one patient died of sudden death and one was submitted to heart transplantation. In conclusion, implantation of a cardioverter-defibrillator by the transvenous technique is a procedure relatively free from complications. During the follow-up lead failure appears to be one of the most relevant complications. Antitachycardia pacing allows effective termination of ventricular tachycardias without cardioversion, with a better compliance.

1995 - DYNAMIC ELECTROPHYSIOLOGICAL BEHAVIOR OF HUMAN ATRIA DURING PAROXYSMAL ATRIAL-FIBRILLATION [Articolo su rivista]
Capucci, A; Biffi, M; Boriani, Giuseppe; Ravelli, F; Nollo, G; Sabbatani, P; Orsi, C; Magnani, B.
abstract

Background The aims of our study were to investigate the meaning of local atrial activation and its behavior during paroxysmal atrial fibrillation and to study the effect of overdrive pacing on local atrial activity. Methods and Results Twenty-five patients with lone paroxysmal atrial fibrillation underwent electrophysiological study. Functional and effective atrial refractoriness was determined. Mean and fifth percentile values of 100 consecutive atrial fibrillation intervals (FF) were evaluated at three atrial sites either at arrhythmia onset or at self-termination (or at minute 5). A high-voltage burst pacing was performed after 6 minutes of stable atrial fibrillation in 10 patients. Mean FF intervals were evaluated 5 seconds before and after atrial pacing. Forty-nine atrial fibrillation episodes were induced: 39 self-terminating within 5 minutes and 10 long-lasting. A significant correlation was found between mean FF and atrial functional refractory period (r=.73, P<.001) and between fifth percentile FF and atrial effective refractory period (r=.57, P<.005). Atrial fibrillation self-termination was associated with significant mean FF prolongation, whereas long-lasting fibrillation behaved the opposite. In 10 patients, burst pacing resulted in significant shortening of the mean FF at the stimulation site; no changes were observed in the two distant recording sites. Conclusions The analysis of the FF intervals demonstrates a strict correlation with atrial functional refractoriness. The self-termination of atrial fibrillation is related to a prolongation of the functional refractoriness (mean FF), whereas a shortening of both functional and effective refractoriness (fifth percentile) is associated with atrial fibrillation persistence. The provoked shortening of the mean FF at the stimulation site is consistent with the presence of a gap of excitability during atrial fibrillation in the human atria.

1995 - ITALIAN MULTICENTER CLINICAL-EXPERIENCE WITH ENDOCARDIAL DEFIBRILLATION - ACUTE AND LONG-TERM RESULTS IN 307 PATIENTS [Articolo su rivista]
Raviele, A; Gasparini, G; Capestro, F; Renzi, R; Favale, S; Rizzon, P; Capucci, A; Boriani, Giuseppe; Marchini, A; Verlato, R; Corrado, D; Carli, L; Abbate, M; Calcaterra, V; Leone, G; Paparella, N; Alboni, P; Derosa, F; Plastina, F; Daulerio, M; Tirella, G; Benedini, G; Musso, G; Mureddu, R; Brignole, M; Oddone, D; Arlotti, M; Lotto, A; Lunati, M; Gasparini, M; Marzegalli, M; Bernasconi, M; Vincenti, A; Ciro, A; Musto, B; Donofrio, A; Renzulli, A; Cotrufo, M; Occhetta, E; Plebani, L; Deponti, R; Salerno, Ja; Bongiorni, Mg; Biagini, A; Pulitano, G; Adornato, E; Pennisi, V; Dini, P; Adinolfi, E; Bellocci, F; Zecchi, P; Auricchio, A; Scafuri, A; Potenza, D; Fanelli, R; Fazzari, M; Pistis, G; Libero, L; Giustetto, C; Vergara, G; Furlanello, F; Petz, E; Morgera, T; Proclemer, A; Feruglio, Ga; Onofri, M; Caico, S; Vicentini, A; Peranzoni, G; Ometto, R.
abstract

This study presents the acute and long-term results of 307 patients (267 men, mean age 57.5 years, 205 suffering from coronary artery disease, mean left ventricular ejection fraction 33.3%) with malignant Ventricular tachyarrhythmias who underwent attempted transvenous ICD implantation with the CPI Endotak lead system in 37 Italian centers. Transvenous ICD implantation was ultimately accomplished in 306 (99.7%) patients. These included 19 subjects with high (< 10 J below output energy of implanted device) defibrillation threshold (DFT) at implant. One hundred sixty-four patients (53%) were implanted with the endocardial lead alone, while 142 also received an SQ patch or SQ array. The mean DFT (not always step-down DFT) at implant was 16.9 +/- 5.7 joules; 15.3 +/- 5.2 joules with biphasic shock and 19.6 +/- 5.4 joules with monophasic shock; P < 0.0001. A significantly higher percentage of patients rested with a biphasic shock could be implanted with adequate safety margin and without an additional SQ patch or SQ array (98% and 81%, respectively). No perioperative deaths occurred. During the mean follow-up of 14.5 +/- 10.2 months, 140 patients (52%) received at least one appropriate shock. An inappropriate shock was observed in 26% of episodes. The 1- and 3-year actuarial incidence of sudden death was 2% and 4%, respectively, and that of total death was 10% and 20%, respectively. A pocket infection requiring ICD explantation occurred in 4 patients (1.4%) and an endocardial lead dislodgment in 11 patients (3.6%). Two patients (0.3%) showed a sensing pin disconnection and six patients (2.3%) had a lead insulation break. The results of this Italian multicenter trial indicate that the CPI Endotak lead system is (I simple, safe, and reliable system for endocardial defibrillation. When compared to epicardial leads, it clearly reduces the perioperative mortality and morbidity, while maintaining a similar efficacy in preventing sudden death and terminating ventricular arrhythmias.

1995 - Long-term results of low energy stimulation: A multicentre study [Articolo su rivista]
Capucci, A.; Boriani, G.; Moracchini, P. V.; Nigro, P.; Bernasconi, A.; Cornacchia, D.; De Matteis, C.; Puglisi, A.; Pulitano, G.; Rusconi, L.; Circo, A.; De Seta, F.; Romano, S.
abstract

A multicentre randomised study was performed on 133 patients (pts.) to evaluate the 3 year follow-up results of threshold behaviour and low energy stimulation by comparing steroid eluting electrodes with Target Tip® electrodes as control. Sixty-five pts. were implanted with VVI and 68 pts. with DDD stimulators. Minimum output allowed by the devices was 0.8V (V) for VVI and 2.5V for DDD pacemakers. The main results showed lower threshold values for the steroid eluting electrodes, compared with the platinised lead (Target Tip®). The advantage of steroid eluting electrodes was statistically appreciable born for ventricular leads (lower mean values of all the measurements: at 3, 7 and 21 days at 2 and 6 months, 1, 2 and 3 years after implantation) and for atrial leads (lower mean values in the measurements performed later). We observed that during the three years follow-up the behaviour of the mean thresholds of pulse duration for both chambers was significantly lower in steroid-eluting leads than in the platinised lead. For example, at 3 years of follow-up steroid-eluting leads had 0.22 ± 10ms ventricular threshold at 0.8V compared with 0.39 ± 13ms in the platinised lead (P<0.001). In the atrium, the steroid-eluting lead's 3 year thresholds at 2.5V were 0.072 ± 0.03ms compared with 0.091 ± 0.06ms for the platinised lead (P<0.01). Seventeen pts. with VVI and steroid eluting electrodes were programmed at 1.6V/0.5ms vs five control (p<0.01). The limitation of lack of lower outputs of the DDD pacemakers did not allow a significant difference in the atrium. No significant loss of capture was demonstrated during low energy stimulation either by 24 Holter recording or at clinical controls. In conclusion, steroid eluting electrodes can maintain low stimulation thresholds even after 3 years. This is probably a consequence of the absence of the 'physiological' threshold increase around the third week after implantation. This threshold behaviour allowed the possibility of safe ventricular stimulation at 1.6V, 0.5ms in a relevant number of patients.

1995 - PROPAFENONE FOR CONVERSION OF RECENT-ONSET ATRIAL-FIBRILLATION - A CONTROLLED COMPARISON BETWEEN ORAL LOADING DOSE AND INTRAVENOUS ADMINISTRATION [Articolo su rivista]
Boriani, Giuseppe; Capucci, A; Lenzi, T; Sanguinetti, M; Magnani, B.
abstract

Study objective: To compare placebo vs two different regimens of propafenone administration-intravenous administration or short-term oral loading-in converting recent-onset atrial fibrillation to sinus rhythm. Design: Single-blind placebo-controlled study. Patients: Eighty-seven patients with atrial fibrillation of recent onset (less than or equal to 7 days' duration) admitted to the hospital without signs of organic heart disease (n=42) or with systemic hypertension without signs or symptoms of heart failure (n=45). The patients were assigned randomly to treatment with intravenous propafenone (29 patients), oral propafenone (29 patients), or placebo (29 patients). Interventions: Administration of propafenone intravenously (2-mg/kg bolus followed by 0.0078 mg/kg/min) or as short-term oral loading (600 mg orally single dose). Patients were submitted to Holter monitoring and conversion to sinus rhythm was evaluated at 1, 3, and 8 h. Results: Conversion to sinus rhythm was obtained within 1 h in 28% with intravenous propafenone, in 3% with oral propafenone, and in 3% with placebo, At 3 h, the efficacy of intravenous propafenone (41%) and of oral propafenone (55%) were statistically superior to placebo (10% of conversions) and at 8 h either intravenous or oral propafenone were effective in almost two thirds of the patients with a statistical difference vs placebo, whose efficacy was 24%, No major side effects were observed. Conclusions: Propafenone as an oral loading dose is an efficacious and fast way of treating atrial fibrillation of recent onset and due to its simplicity of administration and safety can be preferred to the intravenous route.

1995 - Propafenone in the treatment of cardiac arrhythmias. A risk-benefit appraisal [Articolo su rivista]
Capucci, A; Boriani, Giuseppe
abstract

Propafenone is a potent antiarrhythmic agent effective in either supraventricular or ventricular tachyarrhythmias. For proper utilisation, some important pharmacological aspects must be considered, such as nonlinear pharmacokinetics, inability in some patients (poor debrisoquine metabolisers) to oxidise the drug in the liver, existence of at least one active metabolite (5-hydroxy-propafenone) and ability to exert a slight beta-blocking activity. Like all the other antiarrhythmic drugs, propafenone may be associated with adverse effects and may exert proarrhythmic effects. For this reason, its usage must be based on a careful analysis of the risk-benefit ratio, by considering the patient's profile as well as the characteristics of the arrhythmia and its prognostic significance. Propafenone appears to be very effective, and has a favourable risk-benefit profile in the treatment of all supra-ventricular arrhythmias. Particularly, it is effective in converting atrial fibrillation to sinus rhythm and in preventing atrial fibrillation recurrences, and is very effective in the pharmacological control of the arrhythmias of the Wolff-Parkinson-White syndrome. Propafenone is also effective in suppressing ventricular premature complexes and nonsustained ventricular tachycardias. However, because of potential proarrhythmic effects, its use in these arrhythmias must be considered after a careful analysis of the risk-benefit profile, which could be favourable in some patients, but less favourable in others (e.g. patients with coronary artery disease and ventricular dysfunction). In malignant ventricular arrhythmias, further studies are needed to define the limitations of antiarrhythmic drugs in comparison with non-pharmacological treatments, mainly cardioverter/defibrillators. At present, like the other class I antiarrhythmic agents, propafenone does not seem to be a first choice prophylactic agent for malignant ventricular arrhythmias, although more data from controlled studies are needed.

1995 - [Idiopathic atrial fibrillation: clinical-instrumental characterization and thromboembolic risk]. FT Fibrillazione atriale idiopatica: caratterizzazione clinico-strumentale e rischio tromboembolico. [Articolo su rivista]
Boriani, Giuseppe; Capucci, A; Bruni, V; Spedicato, L; Biffi, M; Sabbatani, P; Frabetti, L; Branzi, A; Magnani, B.
abstract

Ninety-two patients with diagnosis of lone atrial fibrillation (AF) were retrospectively identified by our in-hospital records. Among the 92 patients, 62 were males and 30 females. Mean age was 50 +/- 15 years (range 13-81). In 30% of the patients mild to moderate systemic hypertension was present. None had thyroid dysfunction. At the time of our first clinical observation, AF showed the following characteristics: recurrent AF in 58% of the cases (53 patients), chronic AF in 16% of the cases (15 patients) and first episode of AF in 26% of the cases (24 patients). Patient's symptoms were: palpitation in 73% of the cases, dyspnea in 24%, asthenia in 22%, chest pain in 19%, dizziness in 19% and syncope in 9% of the cases. In 9% of the subjects AF was asymptomatic. Recurrent AF presented with more than one episode per day in 12% of the cases, one per week in 16% of the cases, one-two episodes in 1 month in 8% of the cases and between two and six episodes in 1 year in 33% of the cases. Cross-sectional echocardiography, evidenced a higher prevalence of left atrial enlargement in patients with chronic AF (7/15 cases = 47%) either compared to subjects with recurrent AF (5/53 cases = 9%, p < 0.005) or compared to subjects with a first episode of AF (3/24 cases = 11%, p < 0.05). Echocardiographic signs of left ventricular dysfunction (left ventricular enlargement or hypokinesia) were found in 27% of the patients with chronic AF and in 8% of the other two groups (NS).(ABSTRACT TRUNCATED AT 250 WORDS)

1994 - A CONTROLLED-STUDY ON ORAL PROPAFENONE VERSUS DIGOXIN PLUS QUINIDINE IN CONVERTING RECENT-ONSET ATRIAL-FIBRILLATION TO SINUS RHYTHM [Articolo su rivista]
Capucci, A; Boriani, Giuseppe; Rubino, I; Dellacasa, S; Sanguinetti, M; Magnani, B.
abstract

Eighty-seven patients with recent onset atrial fibrillation (less-than-or-equal-to 8 days) without clinical signs of heart failure were randomly allocated to one of the following treatments: (i) oral propafenone (600 mg as a loading dose followed after 8 h by 300 mg t.i.d.); (ii) intravenous digoxin as acute scheme (up to 1.125 mg/24 h) followed after 6 h by hydroquinidine chlorhydrate (total dose, 1350 mg); or (iii) placebo. The patients were submitted to Holter monitoring for 48 h. Results: propafenone achieved higher successful conversion rates at 6, 12 and 24 h compared either with placebo (62% vs. 17%, 83% vs. 34%; 86% vs. 55%; P < 0.01, respectively) or with digoxin at 6 h (62% vs. 38%; P < 0.05) and digoxin plus quinidine at 12 h (83% vs. 48%; P < 0.05). At 48 h, a placebo conversion rate of 76% was observed with consequent lack of any significant difference with the active treatments. Mean conversion times within 48 h were 267 +/- 238 min for propafenone, 648 +/- 631 min for digoxin plus quinidine (P < 0.01 vs. propafenone) and 893 +/- 622 min for placebo (P < 0.001 vs. propafenone). Propafenone and digoxin plasma levels were within the therapeutic range. Asymptomatic phases of atrial flutter with greater-than-or-equal-to 2:1 atrio-ventricular conduction ratio were observed during Holter monitoring, before conversion to sinus rhythm, in four patients treated with propafenone, in one patient taking digoxin plus quinidine and in four patients with placebo. One patient experienced syncope while standing up, 8 h after the beginning of propafenone treatment, due to a 1:1 atrial flutter with aberrant ventricular conduction. In conclusion, propafenone as an oral loading dose followed by oral treatment is highly and quickly effective in converting recent onset atrial fibrillation to sinus rhythm compared with placebo. Digoxin and digoxin plus quinidine, at the doses employed, had a lower success rate and more prolonged conversion times. The high rate of conversion to sinus rhythm during placebo underlines the need for controlled studies in this subset of patients.

1994 - CONVERSION OF RECENT-ONSET ATRIAL-FIBRILLATION BY A SINGLE ORAL LOADING DOSE OF PROPAFENONE OR FLECAINIDE [Articolo su rivista]
Capucci, A; Boriani, Giuseppe; Botto, Gl; Lenzi, T; Rubino, I; Falcone, C; Trisolino, G; Dellacasa, S; Binetti, N; Cavazza, M; Sanguinetti, M; Magnani, B.
abstract

N/A

1993 - DDDR versus DDD and VVIR pacing: A single blind randomised evaluation of symptoms and effort performance [Articolo su rivista]
Capucci, A.; Cazzin, R.; Zardo, F.; Boriani, G.; Zanuttini, D.; Piccolo, E.
abstract

The aim of this study was to evaluate effort performance and subjective symptoms in a within-patient comparison of DDDR, DDD and VVIR pacing. A DDDR pacemaker (Synergyst II, Medtronic) was implanted in 14 patients (mean age 66.5 ± 5.0 yrs.) with sick sinus syndrome or II-III degree AV block. Seven subjects had chronotropic incompetence (maximum heart rate on exercise < 100 beats/min or maximum heart rate after i.v. atropine < 100 beats/min). All the patients underwent a symptom limited exercise test and a questionnaire score after 1 month of DDDR, DDD and VVIR pacing, in random order. The mean effort duration in DDDR was 12.6 ± 3.1 min, in VVIR 11.4 ± 3.4 min (p < 0.01 vs DDDR) and in DDD = 11.0 ± 2.9 min (p < 0.01 vs DDDR). Considering the subgroup of patients with chronotropic incompetence the same differences persisted whilst in the 6 subjects without chronotropic incompetence who completed the study DDDR pacing was statistically superior only to DDD and not to VVIR pacing. VVIR pacing was poorly tolerated since in all the groups of patients its symptom score was significantly higher compared with either DDDR or DDD pacing. In conclusion DDDR pacing is characterised by a superior maximal effort capacity in comparison with DDD pacing and VVIR pacing. In patients with chronotropic incompetence these differences are more marked. Moreover VVIR pacing appears poorly tolerated in subjective terms and in occurrence of side effects.

1993 - DRUGS, SURGERY, CARDIOVERTER DEFIBRILLATOR - A DECISION BASED ON THE CLINICAL PROBLEM [Articolo su rivista]
Capucci, A; Boriani, Giuseppe
abstract

These three therapeutic options are the basis of sudden cardiac death prevention: antiarrhythmic drugs, surgery, and automatic implantable cardioverter defibrillator. Each of these treatments has specific favorable and unfavorable indications. Antiarrhythmic drugs are mainly limited by the low therapeutic profile, proarrhythmic effects, complex pharmacokinetics and pharmacodynamics, possible negative inotropic effects, and the possible change of the organic substratum. Arrhythmia surgery may be limited by the need of a highly trained center, by a relatively high perioperative mortality (up to 15%), and by limited electrophysiological and clinical indications. The implantable cardioverter defibrillator is an expensive tool with a theoretically wide range of clinical indications, with already proven efficacy in converting ventricular fibrillation to sinus rhythm but with unproven efficacy on prolonging survival because of a lack of controlled trials (which, we must admit, is also true for drugs and surgery). The results of the ongoing multicenter trials on this item will clarify this clinical point. The choice among these different therapeutic options is mainly based on hemodynamic status (ejection fraction), feasibility of a surgical treatment, and the electrophysiological characteristics of the ventricular arrhythmia.

1993 - FLECAINIDE ACETATE - CONCENTRATION-RESPONSE RELATIONSHIPS FOR ANTIARRHYTHMIC AND ELECTROCARDIOGRAPHIC EFFECTS [Articolo su rivista]
Boriani, Giuseppe; Capucci, A; Strocchi, E; Calliva, R; Santarelli, A; Biffi, M; Magnani, B.
abstract

In order to evaluate the concentration-response relationship for either antiarrhythmic or electrocardiographic effects, 13 patients with symptomatic, stable, premature ventricular contractions (>100/hour) were selected, and flecainide was administered as a single oral dose (200 mg) and as chronic treatment (150 mg b.i.d. for 21 days). In both settings a Holter monitoring, serial electrocardiogram (ECG) tracings and serum samples for flecainide concentrations were obtained; the relationships between drug levels, antiarrhythmic efficacy, and ECG modifications were analysed. The results obtained indicated that QRS and PR intervals lengthened significantly either after acute oral administration or after chronic treatment by 21-36% (mean values), and that the ARS interval changes were significantly correlated to serum flecainide concentrations (r=0.68, p<0.001 after acute and r=0.79, p<0.001 after chronic administration). However, for any given plasma concentration of flecainide, the percentage widening of QRS intervals was smaller after chronic treatment, as shown by the different slopes of the correlation lines (7.7+/-4.0%.ml.mu g(-1) after acute dosing versus 3.8+/-1.1%.ml.mu g(-1) after chronic treatment, p<0.001). This finding suggests a relative reduction of flecainide's effects on ECG intervals during chronic treatment, while the antiarrhythmic efficacy was maintained (flecainide effective in 8/13 patients in acute and in 11/13 patients in chronic) without significant differences between flecainide's minimal effective concentrations (262+/-119 ng/ml and 319+/-276 ng/ml for acute vs chronic respectively). We conclude that during chronic treatment a dissociation seems to occur between the electrocardiographic and the antiarrhythmic effects and this could limit the clinical usefulness of monitoring QRS intervals.

1993 - Flecainide: Evidence of different concentration-response relationships for antiarrhythmic and electrocardiographic effects [Relazione in Atti di Convegno]
Boriani, G.; Capucci, A.; Strocchi, E.; Santarelli, A.; Spedicato, L.; Biffi, M.; Magnani, B.
abstract

In order to evaluate the concentration-response relationship for either antiarrhythmic or electrocardiographic (ECG) effects, 13 patients with stable and frequent (>100/hour) premature ventricular contractions (PVCs) were selected and flecainide (FLE) was administered as acute oral dose (200 mg) and as chronic treatment (150 mg b.i.d, for 21 days), followed by wash out. In each phase Holter monitoring, serial ECG tracings and serum samples for FLE concentrations were performed. The relationships between FLE concentrations and either ECG effects or antiarrhythmic efficacy, analysed by calculation of the minimal effective concentration (efficacy = reduction > 90% of PVCs), were assessed. Results: QRS and PR intervals lengthened significantly either after acute oral administration or after chronic treatment by 21-36% (mean values) and QRS interval changes were significantly related to serum FLE concentrations (r = 0.68, p < 0.001 in acute and r = 0.79, p < 0.001 in chronic administration). However, the relationship between FLE concentrations and QRS intervals percentual lengthening showed a reduction in the slope of the regression lines in chronic vs. acute treatment (average of the individual values = 7.7 ± 4.0% ml.μg in acute versus 3.8 ± 1.1% ml.μg in chronic, p < 0.001), thus indicating a relative reduction during chronic treatment of the drug effects on ECG intervals. Antiarrhythmic efficacy was reached in 8/13 patients in acute and in 11/13 patients in chronic without significant differences in FLE minimal effective concentrations (acute = 262 ± 119 ng/ml, chronic = 319 ± 276 ng/ml, n.s.). In conclusion during chronic treatment with FLE a dissociation between ECG and antiarrhythmic effects occurs, with a relative reduction in the extent of QRS lengthening at a given FLE concentration but without changes in the relationship between FLE concentrations and antiarrhythmic effects. This finding limits the clinical usefulness of QRS intervals changes monitoring during treatment with FLE.

1993 - Mechanisms of atrial fibrillation [Relazione in Atti di Convegno]
Capucci, A.; Biffi, M.; Boriani, G.; Spedicato, T.; Santarelli, A.; Orsi, C.; Ravelli, F.; Nollo, G.; Magnani, B.
abstract

The electrophysiologic mechanisms basis of atrial fibrillation have been extensively investigated in animal models and clinical electrophysiology. Short atrial refractoriness and slow conduction are constant findings in AF patients. Less information is available about human atrial fibrillation behaviour, expecially regarding its self termination and persistence. Fourteen patients with lone paroxysmal atrial fibrillation underwent an electrophysiologic study. Mean and P5 of 100 consecutive FF intervals were evaluated at 3 atrial sites either at arrhythmia onset or at self termination (or at the 5th minute). Twenty-eight atrial fibrillation episodes were induced: 21 self terminating within 5 minutes, and 7 long lasting. A significant correlation was found between mean FF interval and atrial functional refractory period (r = 0.79, p < 0.001), and between P5 FF interval and atrial effective refractory period (r = 0.6, p < 0.005). Atrial fibrillation self termination was associated with significant mean FF prolongation, while long lasting fibrillation behaved the opposite. The FF intervals analysis during fibrillation showed a significant relation to atrial electrophysiologic properties and offer a useful parameter for the comprehension of AF spontaneous behaviour and for the evaluation of therapeutic interventions.

1993 - Oral cardioversion with flecainide in supraventricular arrhythmias [Relazione in Atti di Convegno]
Capucci, A.; Boriani, G.; Lenzi, T.; Trisolino, G.; Biffi, M.; Spedicato, L.; Binetti, N.; Cavazza, M.; Magnani, B.
abstract

Flecainide is a class 1C antiarrhythmic drug with proven efficacy by the intravenous route in terminating supraventricular arrhythmias. Pharmacokinetic studies evidenced how its administration as acute oral loading dose obtains therapeutic drug levels within 2-3 hours after administration. We therefore planned a controlled study evaluating the efficacy of a single oral loading dose of flecainide (300 mg q.d.) in converting recent onset atrial fibrillation to sinus rhythm. The data confirmed the high efficacy of this kind of treatment (84% of conversion within 8 hours). Therefore acute oral loading with FLE is proposable for extensive in-hospital employment in order to treat acutely, under clinical observation, supraventricular arrhythmias in patients without heart failure or left ventricular disfunction.

1993 - Young subjects with apparently idiopathic complex ventricular arrhythmias: Non-invasive cardiological evaluation and follow-up [Relazione in Atti di Convegno]
Carini, G. C.; Di Pasquale, G.; Capucci, A.; Ribani, M. A.; Boriani, G.; Fabii, S.; Grepioni, A.; Pinelli, G.; Magnani, B.
abstract

The prognosis of patients (pts) with ventricular arrhythmias (VA) not associated with structural heart disease is not well defined. Aim of this study was to evaluate the presence of myocardial disease and the prognosis in a group of pts with complex VA and apparently normal heart. We studied 19 pts, 13 M and 6 F, aged < 50 years (mean 33, range 15-45), with > 100 ventricular premature beats (VPBs)/hour at Holter recording and no signs of heart disease at clinical examination. Baseline examination consisted of resting ECG, chest X-ray, exercise ECG testing, transthoracic echocardiography (TTE) and radionuclide angiocardiography (RNA). After a mean follow-up period of 53 ± 9.5 months all pts but four that refused to attend the clinical examination, were revaluated. In addition to the baseline work-up, 8 pts performed transesophageal echocardiography (TEE) and 11 magnetic resonance imaging (MRI). Resting ECG was normal in all pts but one with inverted T waves in V1-V3 leads. Exercise ECG testing did not show ischemia or worsening of VA in any pts. The mean number of VPBs at 24 hour Holter monitoring was 11.6 ± 8.946; 9 pts (47%) had repetitive forms (couplets and non sustained ventricular tachycardia). The VPBs morphology was LBBB in 16 pts (84%) and polymorphous in 3 (16%). TTE showed mild abnormalities, such as mitral valve prolapse and left ventricular false tendonsi in 4 pts, exaggerated right ventricular trabecular appearance in 6, while it was normal in 9. The RNA right ventricular ejection fraction (RVEF) was lower than normal in the majority of pts (mean 38.9 ± 9), while RNA left ventricular ejection fraction (LVEF) was < 50% only in 5 pts (mean 53.7 ± 8.6). During the follow-up period no cardiac events or symptoms worsening occurred in any pts. Resting ECG and TEE was unchanged in all pts, while the mean number of VPBs at 24 hour Holter recording was reduced (6.622 ± 11.407); 3 pts had < 10 VPBs/hour. TEE showed exaggerated right ventricular trabecular appearance without abnormalities of segmental contraction in 4 pts and was normal in the other 4 pts. The MRI excluded the present of right ventricular cardiomyopathy in all 11 pts that performed it. In conclusion, our data suggest that these pts with apparently idiopathic complex VA and no signs of significant heart disease detectable by non invasive tests are clinically stable over time and have no cardiac events during a more than 4 years follow-up period. Minor abnormalities, particularly mild right ventricular dysfunction, are frequently detected and therefore TEE should be routinely performed to evaluate with more accuracy the right ventricle. MRI is an extremely valuable diagnostic tool and is recommended whenever the other non-invasive tests give conflicting results and are not sufficient to rule out a myocardial disease.

1993 - [Paroxysmal atrial fibrillation: the significance of the dynamic behavior of the atrial cycle]. FT Fibrillazione atriale parossistica: significato del comportamento dinamico del ciclo atriale. [Articolo su rivista]
Biffi, M; Capucci, A; Boriani, Giuseppe; Santarelli, A; Mignatti, V; Magnani, B.
abstract

The aim of this study was to evaluate the dynamic atrial endocardial activation pattern during atrial fibrillation and to investigate the electrophysiologic changes related to the self-termination of the arrhythmia. Twenty patients with daily recurrences of lone paroxysmal atrial fibrillation episodes underwent electrophysiological study with contemporary recording of the atrial signal in high right atrium, low right atrium and coronary sinus. Sixty episodes lasting longer than 1 min were recorded, 22 spontaneous and 38 induced with a single extrastimulus. A significant correlation has been demonstrated for the mean of 100 consecutive intervals evaluated at the arrhythmia onset and the atrial functional refractory period (R = 0.73, p < 0.001). Mean FF length increased significantly in the minute preceding self-termination of atrial fibrillation in all the 3 recording sites. On the contrary, a significant decrease of mean FF length was documented in long lasting episodes. Self-termination of atrial fibrillation episodes implies a peculiar pattern of intra-atrial interval. Therefore the analysis of FF intervals seems to have pathophysiological implication and may be applied also to evaluate pharmacological interventions.

1993 - β-Blocking Properties of Propafenone in Extensive Oxidisers: A Study on Heart Rate Behaviour during Holter Monitoring [Articolo su rivista]
Boriani, Giuseppe; Capucci, Alessandro; Strocchi, Enrico; Marchesini, Bruno; Santarelli, Andrea; Biffi, Mauro; Magnani, Bruno
abstract

The aims of this study were to evaluate whether the beta-blocking effect during propafenone treatment is clinically significant even in extensive metabolisers of debrisoquine (&gt; 90% of Caucasians), and to identify the kinetic determinants of such an effect. 11 patients, classified as extensive oxidisers of debrisoquine, with stable ventricular contractions (&gt; 100/hour) were studied by Holter monitoring in basal condition and after 14 days of treatment with propafenone 300mg 3 times daily. A complete pharmacokinetic assessment, with serial plasma samples for propafenone and 5-hydroxy propafenone determination, was performed during washout. A mean reduction in either maximum heart rate (HR max) [-7.1%] or mean heart rate (HR mean) [-4.2%] was observed during treatment with propafenone, but its extent varied within the patient population from 0 to 17%. The degree of HR slowing was related to the area under the concentration-time curve of propafenone (r = 0.725, p &lt; 0.02 for HR max; r = 0.715, p &lt; 0.02 for HR mean) as well as to propafenone minimum concentrations at steady-state (r = 0.809, p &lt; 0.005 for HR max; r = 0.752, p &lt; 0.01 for HR mean) without significant relationships to 5-hydroxy propafenone levels or to age. HR max percentage reduction during therapy was significant compared with basal values only during daytime hours (-8.1%, p &lt; 0.005), suggesting a beta-blocking effect, and was again related to the area under the concentration-time curve of propafenone (r = 0.704, p &lt; 0.02) and to propafenone minimum steady-state concentrations (r = 0.786, p &lt; 0.005). A strict relationship between oxidative metabolism, evaluated by debrisoquine hydroxylation and propafenone metabolism, was observed (r = 0.982, p &lt; 0.001). In conclusion, a beta-blocking effect during treatment with propafenone 300mg 3 times daily can be detected even by Holter monitoring performed during daily activity. However, the extent of such an effect varies widely between individuals, depending on propafenone plasma levels. The degree of oxidative metabolism is thus a major determinant of the clinical beta-blocking effect of propafenone.

1992 - ATRIAL PREMATURE BEATS COUPLING INTERVAL DETERMINES LONE PAROXYSMAL ATRIAL-FIBRILLATION ONSET [Articolo su rivista]
Capucci, A; Santarelli, A; Boriani, Giuseppe; Magnani, B.
abstract

In 20 patients with recurrent episodes of lone paroxysmal atrial fibrillation we assessed the onset pattern of each episode of either atrial fibrillation or of atrial flutter during a 24-h Holter monitoring. We evaluated 24 twenty-four-hour Holter tape recordings and our data are related to 168 episodes of paroxysmal atrial fibrillation and 27 episodes of paroxysmal atrial flutter. Eighty-five percent of atrial fibrillations and 67% of atrial flutters were of short duration (< 5 min). The majority of patients (80%) had either nocturnal or daily episodes of arrhythmia and PP intervals immediately before onset of arrhythmia did not show significant variations in 77% of cases. The coupling interval of the supraventricular premature beats eliciting atrial fibrillation was significantly shorter than the coupling intervals of the spontaneous isolated supraventricular premature beats (p < 0.0001); again, in 6 patients with either atrial fibrillation or flutter, the coupling interval at onset of fibrillation was significantly shorter in comparison to flutter (p < 0.0001). In conclusion, vagal or sympathetic prevalence does not seem to influence significantly the beginning of the arrhythmia, while the coupling interval of the atrial premature beats plays a critical role in the inducibility of atrial flutter or fibrillation.

1992 - EFFECTIVENESS OF LOADING ORAL FLECAINIDE FOR CONVERTING RECENT-ONSET ATRIAL-FIBRILLATION TO SINUS RHYTHM IN PATIENTS WITHOUT ORGANIC HEART-DISEASE OR WITH ONLY SYSTEMIC HYPERTENSION [Articolo su rivista]
Capucci, A; Lenzi, T; Boriani, Giuseppe; Trisolino, G; Binetti, N; Cavazza, M; Fontana, G; Magnani, B.
abstract

Sixty-two patients with recent-onset (less-than-or-equal-to 1 week) atrial fibrillation (New York Heart Association functional class 1 and 2) were randomized in a single-blind study to 1 of the following treatment groups: (1) flecainide (300 mg) as a single oral loading dose; or (2) amiodarone (5 mg/kg) as an intravenous bolus, followed by 1.8 g/day; or (3) placebo for the first 8 hours. Twenty-four-hour Holter recording was performed, and conversion to sinus rhythm at 3, 8, 12 and 24 hours was considered as the criterion of efficacy. Conversion to sinus rhythm was achieved within 8 hours (placebo-controlled period) in 20 of 22 patients (91%) treated with flecainide, 7 of 19 (37%) treated with amiodarone (p <0.001 vs flecainide), and 10 of 21 (48%) treated with placebo (p <0.01 vs flecainide). Resumption of sinus rhythm within 24 hours occurred in 21 of 22 patients (95%) with flecainide and in 17 of 19 (89%) with amiodarone (p = not significant). Mean conversion times were shorter for flecainide (190 +/- 147 minutes) than for amiodarone (705 +/- 418; p <0.001). No major side effects occurred. At Holter monitoring, a pause of 9.3 seconds was observed in 1 asymptomatic patient treated with flecainide. Phases of atrial flutter with a ventricular rate less-than-or-equal-to 150 beats/min were detected before sinus conversion in 1 patient receiving placebo and in 2 receiving flecainide. In conclusion, flecainide administered orally in a single loading dose is highly effective in converting recent-onset atrial fibrilation to sinus rhythm and is more rapid than is intravenous amiodarone. This in-hospital regimen in patients without major organic heart diseases was safe and well-tolerated.

1992 - EVALUATION BY CARDIOPULMONARY EXERCISE TEST OF DDDR VERSUS DDD PACING [Articolo su rivista]
Capucci, A; Boriani, Giuseppe; Specchia, S; Marinelli, M; Santarelli, A; Magnani, B.
abstract

In eight patients (age 62 +/- 6 years) a DDDR pacemaker was implanted for sick sinus syndrome (three cases) or second- and third-degree AV block (five cases). In five subjects chronotropic incompetence (maximal heart rate on effort < 110 beats/min) was present before implantation. One month after implantation,the patients were randomized to DDDR or DDD pacing for 3 weeks each, with subsequent crossover, and at the end of each period a symptom limited cardiopulmonary exercise test (25 watts/2 min) was performed and the patients were requested to fill a symptoms questionnaire. Results: DDDR pacing, compared to DDD, was associated with higher maximal heart rates (127 +/- 20 vs 110 +/- 27 beats/min, P < 0.02), higher [VO2 max (25.4 - 6.1 vs 21.5 +/- 7.8 mL/kg/ per min, P < 0.03) and higher VO2 at the anaerobic threshold (20.3 +/- 5.0 vs 15.8 +/- 4.9 mL/kg per min, P < 0.03), without significant differences in mean exercise time (526 +/- 193 vs 472 +/- 216 sec, NS). The increase in VO2 max obtained in DDDR versus DDD was significantly related to the increase in maximal heart rate (r = 0.72, P < 0.05) and the increase in VO2 at the anaerobic threshold obtained in DDDR versus DDD was related to the increase in heart rate at the anaerobic threshold (r = 0.81, P < 0.02). In patients with chronotropic incompetence the improvement obtained in DDDR versus DDD was even more significant (VO2 max = 22.7 +/- 5.9 vs 16.1 +/- 4.4 mL/kg per min, P < 0.03; VO2 at the anaerobic threshold = 18.4 +/- 5.1 vs 13.2 +/- 2.8 mL/kg per min, P < 0.05; exercise time = 438 +/- 132 vs 352 +/- 150 sec, P < 0.02). In the population as a whole, no significant differences were found relative to subjective symptoms, meanwhile in patients with chronotropic incompetence a better subjective tolerance was apparent with DDDR than with DDD pacing. In conclusion, DDDR pacing induces a significant improvement of exercice capacity, in comparison to DDD pacing, related to the ability to reach higher heart rates during exercise. This phenomenon is particulary evident in patients with chronotropic incompetence in whom DDDR pacing also is subjectively better tolerated.

1992 - INTRAVENOUS ADMINISTRATION OF PROPAFENONE [Articolo su rivista]
Capucci, A; Boriani, Giuseppe
abstract

N/A

1992 - ROLE OF THE AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IN THE PREVENTION OF SUDDEN CARDIAC DEATH [Articolo su rivista]
Capucci, A; Boriani, Giuseppe
abstract

N/A

1992 - Sick sinus syndrome and diffuse impairment of the conduction system in a child: successful pacing with a steroid eluting endocardial pacing lead [Articolo su rivista]
Capucci, A; Boriani, Giuseppe; Galli, R; Picchio, Fm; Pierangeli, A; Magnani, B.
abstract

A 9-year-old patient who had had a syncope was found to have atrial flutter in a resting electrocardiogram (ECG). Brief phases of sinus arrest had previously occurred after drug conversion to sinus rhythm. Structural heart disease was excluded by cardiac catheterization and angiography. Electrophysiologic study revealed a sick sinus syndrome, associated with diffuse impairment of the conduction system (supra-, infra-, and intrahisian block). Epimyocardial and an endocardial pacemaker implantation failed because of high stimulation threshold, after 3 years and 2 weeks, respectively. At the third implantation a steroid-eluting endocardial pacing lead was used and satisfactory pacing was still present 2 years later.

1991 - A DOUBLE-BLIND CROSSOVER COMPARISON OF FLECAINIDE AND SLOW-RELEASE MEXILETINE IN THE TREATMENT OF STABLE PREMATURE VENTRICULAR COMPLEXES [Articolo su rivista]
Capucci, A; Dipasquale, G; Boriani, Giuseppe; Carini, G; Balducelli, M; Frabetti, L; Carozzi, A; Finzi, A; Pinelli, G; Magnani, B.
abstract

In 24 patients with stable premature ventricular contractions (PVCs) greater-than-or-equal-to 100/h, Lown class greater-than-or-equal-to 2 the relative anti-arrhythmic efficacy of flecainide 150 mg twice daily and slow-release mexiletine 360 mg twice daily was evaluated in a double-blind placebo-controlled randomized crossover study. All the patients had normal ventricular function. Criteria of efficacy were: reduction greater-than-or-equal-to 70% of PVCs or reduction greater-than-or-equal-to 50% with abolition of Lown class > 2 arrhythmias or suppression of non-sustained ventricular tachycardias (nSVT). Twenty-two patients completed the study protocol. The placebo phases showed comparable results and no carry over effect. The criteria of efficacy were fulfilled in 20 of the 22 patients (91%) on flecainide and in 12 of the 22 (55%) on mexiletine. The absolute reductions of PVCs, couplets and nSVT obtained on flecainide and mexiletine, in comparison to the placebo, were statistically significant (p < 0.01 for flecainide, p < 0.05 for mexiletine). Flecainide was superior to mexiletine in overall PVC reduction (p < 0.05). In the 17 patients with couplets the reduction obtained with flecainide was superior to mexiletine (p < 0.05). Both drugs were highly effective on nSVT. At steady state, the mean plasma levels of both drugs were within the range of clinical efficacy. The drugs were well tolerated and no patient withdrew because of side-effects. It was concluded that at the dosages employed flecainide was superior to mexiletine in reducing premature ventricular contractions and in abolishing couplets. The efficacy of both drugs for non-sustained ventricular tachycardias was comparable. Both drugs were highly effective by comparison with the placebo.

1991 - FLECAINIDE - EVIDENCE OF NONLINEAR KINETICS [Articolo su rivista]
Boriani, Giuseppe; Strocchi, E; Capucci, A; Calliva, R; Frabetti, L; Ambrosioni, E; Magnani, B.
abstract

The pharmacokinetics of flecainide has been studied in 12 patients with ventricular arrhythmias, both after single administration and during chronic treatment. Both the half-life and the AUC were significantly increased during chronic treatment. This suggests that the kinetics of flecainide might be non-linear also in patients with normal kidney and liver function. The increase in plasma flecainide levels during chronic treatment could not be predicted, so close monitoring of its plasma levels is advisable.

1991 - IMPORTANZA DEL GRADO DI METABOLIZZAZIONE EPATICA OSSIDATIVA NEL CONDIZIONARE LA FARMACOCINETICA E LA FARMACODINAMICA DEL PROPAFENONE [Articolo su rivista]
Boriani, Giuseppe; Capucci, A; Strocchi, E; Marchesini, B; Baroni, M; Frabetti, L; Ambrosioni, E; Magnani, B.
abstract

N/A

1991 - La fibrillazione atriale. Problemi clinici e terapeutici [Monografia/Trattato scientifico]
Capucci, A; Boriani, Giuseppe
abstract

N/A

1991 - Therapeutic implications of propafenone in atrial fibrillation by the light of electrophysiologic profile [Relazione in Atti di Convegno]
Capucci, A.; Boriani, G.; Biffi, M.; Ravelli, F.; Nollo, G.; Santarelli, A.; Magnani, B.
abstract

N/A

1991 - [Idiopathic atrial fibrillation: clinical and therapeutic problems]. FT La fibrillazione atriale idiopatica: problematiche cliniche e terapeutiche. [Articolo su rivista]
Capucci, A; Boriani, Giuseppe
abstract

Atrial fibrillation (AF) is defined as idiopathic when no one heart disease can be documented by clinical examination or by laboratory investigations. Epidemiological studies have shown that almost one third of all the cases of AF are idiopathic and that their incidence increases with age. Idiopathic AF may have different clinical manifestations: the paroxysmal form, characterised by long-lasting episodes, the transient recurrent form, characterised by frequent self-terminating episodes, or, less commonly, the chronic form. According to the literature, the risk of thromboembolic complications in idiopathic AF is not elevated and certainly lower than in AF associated with heart disease. By a clinical evaluation patients in whom an electrical cardioversion is necessary for reestablishing the sinus rhythm can be identified, considering that definite contraindications to electrical cardioversion exist. For prophylaxis of recurrences of AF the classical treatment with class 1A antiarrhythmic drugs (disopyramide or quinidine) is not very effective and not well tolerated; recently class 1C antiarrhythmic drugs have been employed with better results. In patients without heart failure their employment appears sufficiently safe. Amiodarone is certainly very effective but considering the serious side effects, its use must be limited to selected cases. Moreover non-pharmacological treatments (catheter ablation and surgery) have been developed recently for selected cases of AF refractory to antiarrhythmic drugs.

1990 - Hyperkinetic ventricular arrhythmia during the treadmill test in chronic ischemic heart disease [Articolo su rivista]
Baroni, M; Boriani, Giuseppe; Capucci, A; Magnani, B.
abstract

Aim of this study was to evaluate the pattern of onset and the characteristics of ventricular arrhythmias (VA) observed during treadmill test (TT) in patients with chronic ischemic heart disease (CIHD). Two groups of patients with CIHD were retrospectively compared: group A consisted of 120 consecutive patients with premature ventricular beats (PVBs) either isolated (greater than 2/min) or repetitive during exercise, or maximal exercise, or recovery; group B consisted of 140 consecutive patients without PVBs during TT. The two groups were comparable in mean age, male/female ratio, incidence of previous myocardial infarction, of previous coronary artery by-pass graft or of percutaneous transluminal coronary angioplasty. There were no significant differences between the two groups regarding the parameters evaluated during TT: duration of exercise, maximal heart rate, heart rate-systolic blood pressure product as well as in the percentage of positive tests for acute myocardial ischemia (51.6% vs 40.7%). In the two subgroups of patients who underwent coronary arteriography and left ventricular angiography (24/120 and 23/140 patients respectively) no differences were found in the number and distribution of critical coronary stenosis and of dyskinetic or akinetic areas. In both groups A and B the QTc interval at maximal exercise was significantly longer than its value at rest (p less than 0.001), but there was no relevant difference between the two groups. In group A patients with VA during maximal exercise (n = 60) showed a higher prevalence of complex VA (class Lown greater than or equal to 3) compared to the others (p less than 0.005).(ABSTRACT TRUNCATED AT 250 WORDS)

1990 - Lone paroxysmal atrial fibrillation episodes: Mechanisms of onset and patterns of atrial activation [Relazione in Atti di Convegno]
Capucci, A.; Biffi, M.; Boriani, G.; Frabetti, L.; Magnani, B.
abstract

N/A

1990 - Minimal effective concentration values of propafenone and 5-hydroxy-propafenone in acute and chronic therapy [Articolo su rivista]
Capucci, A; Boriani, Giuseppe; Marchesini, B; Strocchi, E; Tomasi, L; Balducelli, M; Frabetti, L; Ambrosioni, E; Magnani, B.
abstract

We evaluated the antiarrhythmic efficacy and the minimal effective concentrations of propafenone and its metabolite 5-hydroxy-propafenone during a) acute intravenous infusion (1.5 mg/kg in bolus followed by 45 minutes infusion), b) an acute oral single-dose test (450 mg), and c) 14-day chronic therapy (300 mg tid) followed by a washout. Oxidative metabolism was assessed by a debrisoquine oral test in every patient. Eleven patients with stable ventricular premature beats (VPBs) greater than or equal to 300/hr and Lown class greater than or equal to 3 completed the study. The main results emphasized a certain discrepancy between the clinical effect of the acute intravenous infusion (efficacy in 5 out of 11 patients) and of the acute oral test and chronic therapy (efficacy in 11/11), with a time lag of the ECG changes during the acute intravenous infusion. The minimal effective concentrations were lower after acute oral administration compared with chronic treatment both for propafenone (200 +/- 189 ng/ml vs. 492 +/- 530 ng/ml; p less than 0.05) and for 5-hydroxy-propafenone (82 +/- 40 ng/ml vs. 149 +/- 80 ng/ml; p less than 0.02). A linear correlation was demonstrated between drug/metabolite ratios of propafenone and debrisoquine, either after acute oral (r = 0.91) or after chronic administration (r = 0.84). The pharmacokinetics of propafenone was nonlinear and showed wide interindividual variations.(ABSTRACT TRUNCATED AT 250 WORDS)

1990 - Pseudoischemic T waves: a possible electrophysiologic mechanism [Articolo su rivista]
Capucci, A; Baroni, M; Boriani, Giuseppe; Magnani, B.
abstract

N/A

1990 - Study on the minimal effective concentration of antiarrhythmic agents. Experience with propafenone [Articolo su rivista]
Capucci, A.; Boriani, G.; Strocchi, E.; Marchesini, B.; Ambrosioni, E.; Magnani, B.
abstract

N/A

1990 - USEFULNESS OF NICORANDIL IN CONGESTIVE HEART-FAILURE [Articolo su rivista]
Galie, N; Varani, E; Maiello, L; Boriani, Giuseppe; Boschi, S; Binetti, G; Magnani, B.
abstract

N/A

1990 - [Determination of oxidative phenotype in a sample population and correlation with the pharmacokinetics of propafenone] [Articolo su rivista]
Boriani, G; Strocchi, E; Capucci, A; Boschi, S; Frabetti, L; Ambrosioni, E; Magnani, B
abstract

Propafenone, like other cardioactive drugs (metoprolol, propranolol, encainide) is submitted to oxidative metabolism, evaluable by assessment of debrisoquine oxidative capacity. Two phenotypes have been described: extensive and poor oxidizers, with interethnic differences in the prevalence of poor oxidizers. Aims of this study were: 1) to assess the oxidative phenotype in a sample of the Italian population and 2) to evaluate the relationships between oxidative capacity and propafenone pharmacokinetics or pharmacodynamics. The ratio between debrisoquine (D) and 4-hydroxy-debrisoquine (4-OH-D) in the urines after D administration (10 mg) was employed to characterize oxidative phenotype in 90 subjects (42 arrhythmia patients and 48 healthy volunteers). In 10 patients, extensive oxidizers of debrisoquine, we studied propafenone (P) and 5-hydroxy-propafenone (5-OH-P) kinetics after acute oral administration (450 mg) and chronic oral treatment (300 mg tid for 2 weeks), followed by wash out.

1989 - Intravenous and oral propafenone: Pharmacokinetic-pharmacodynamic relationships and clinical implications [Articolo su rivista]
Capucci, A.; Boriani, G.; Magnani, B.
abstract

N/A

1989 - Tocainide and metoprolol: an efficacious therapeutic combination in the treatment of premature ventricular beats [Articolo su rivista]
Capucci, A; Frabetti, L; Gubelli, S; Boriani, G; Marchesini, B; Boschi, S; Ambrosioni, E; Magnani, B
abstract

A double-blind crossover study was performed in 20 patients to verify the efficacy of tocainide plus metoprolol in patients with premature ventricular contractions (PVCs) class Lown greater than or equal to 2 (mean frequency greater than or equal to 30/h) judged as being "stable" by at least three basal 24-h Holter ECGs with PVC variation of less than +/- 25%. All 20 patients were submitted to a placebo period; and all were subsequently randomized to therapy with tocainide 1800 mg/day or metoprolol 200 mg/day for 15 days and then to tocainide 1800 mg + metoprolol 200 mg/day or tocainide 1200 mg + metoprolol 200 mg/day for 15 days, followed by a crossover of the two combination treatments. At steady state in every stage we controlled for plasma levels of the drugs, a 24-h Holter recording, and a 12-lead ECG. A modified Lown score was evaluated together with the Lown class. Tocainide (mean plasma level 3.3 +/- 0.7 micrograms/ml) was efficacious in 3 of 8 patients, the modified Lown score decreased from 63 +/- 32 (placebo period) to 42 +/- 27 (p less than 0.01) and Lown 4B arrhythmias were abolished in 3 of 4 patients. Metoprolol (mean plasma level 97.4 +/- 89.6 ng/ml) was efficacious in 2 of 10 patients; the modified Lown score and Lown classes did not change significantly. Administration of tocainide 1200 mg + metoprolol 200 mg obtained a positive response in 9 of 12 patients, the modified Lown score decreased significantly compared with placebo (from 53 +/- 31 to 32 +/- 30, p less than 0.01) and Lown 4B arrhythmias were abolished in 2 of 5 cases. Tocainide 1800 mg plus metoprolol 200 mg was scarcely tolerated owing to neurologic and gastroenteric side effects, and only three patients completed this stage with no better antiarrhythmic results compared to the lower dose. In conclusion, the combination of tocainide at 1200 mg and metoprolol 200 mg is well tolerated, efficacious in a high percentage of patients, and superior to single drug therapy in patients with stable PVCs.

1989 - [Cerebral and renal aspergillosis in a patient with orthotopic heart transplant: diagnosis, treatment and follow-up] [Articolo su rivista]
Boriani, G; Mirri, A; Iacobitti, P; Magnani, G; Ferretti, R M; Gamba, A; Mamprin, F; Fiocchi, R; Ferrazzi, P; Binetti, G
abstract

A cardiac transplant recipient developed systemic aspergillosis with abscesses from aspergillus fumigatus in the brain and the right kidney. Surgical resections were performed (lobectomy for the brain abscess, partial resection for the renal abscess followed, after extension of the infection, by right nephrectomy) combined with therapy with itraconazole, a new antimycotic agent. Recovery from the infection was obtained and at 18 months of follow-up the patient feels well without signs of recurrences of the infection.

1989 - [Electrocardiographic, clinical and prognostic evaluation of sustained ventricular tachycardia in acute and chronic ischemic heart disease] [Articolo su rivista]
Boriani, G; Balducelli, M; Capucci, A; Magnani, B
abstract

We retrospectively evaluated 48 patients with sustained ventricular tachycardia (STV), in whom a 12 lead ECG had been recorded during arrhythmia, considering two groups: pts. with acute or subacute myocardial infarction (MI group = 15 pts.) and pts. with chronic post infarction ischemic heart disease (CPIIHD group = 33 pts.). The electrocardiographic patterns in the basal ECG and during SVT (16 SVT in the MI group, 40 in the CPIIHD group) as well as the in-hospital and long-term prognosis were evaluated. The two groups were comparable as far as mean age, site of acute or previous infarction, and baseline ECG parameters are concerned. QTc values greater than 440 msec were present in 64.5% of the cases. The ECG recording during SVT showed longer duration of QRS in CPIIHD group (171 +/- 39 msec) versus MI group (140 +/- 25 msec) (p less than 0.005). In comparison to basal ECG, Q waves in the SVT recording were in the same site (47.2%) or in a wider site (38.1%), rarely (10.9% of the cases) there was a discordance between the two tracings. In-hospital mortality was 40% (6/15 pts.) in MI group, related to severe hemodynamic impairment, 15.1% (5/33 pts.) in CPIIHD group. During the follow-up (mean 38.4 months) survival in CPIIHD group was 89.3% at 12 months, in MI group 88.9% at 12 months. In CPIIHD patients SVT was recurrent in 60.6% of the cases.(ABSTRACT TRUNCATED AT 250 WORDS)

1989 - [Non-invasive diagnosis of acute rejection in heart transplant] [Articolo su rivista]
Varani, E; Mirri, A; Iacobitti, P; Magnani, G; Caporale, R; Boriani, G; Ferretti, R M; Ferrazzi, P; Gamba, A; Fiocchi, R
abstract

The purpose of this study was to evaluate the sensibility of some clinical and non-invasive parameters in the early diagnosis of cardiac rejection in heart transplant patients. Eighteen patients (15 males and 3 females) aged 13-57 years (mean 44 +/- 14), with orthotopic heart transplant were followed clinically for a mean period of 15 +/- 8.7 months (range 3-27). They were all treated with cyclosporin, associated with azathioprine or prednisone, or both. During the same day of the endomyocardial biopsy, the patients were submitted to a clinical examination, 12 leads ECG and 2-dimensional and Doppler-echocardiography. The following parameters were evaluated: systolic and diastolic blood pressure, heart rate, body weight, summated QRS voltage in the 12 leads ECG, interventricular septum and left ventricular posterior wall end-diastolic thickness, left ventricular myocardial mass and fractional shortening, isovolumic relaxation time. Biopsy specimens were graded according to the Billingham criteria. Totally, 251 biopsies were performed: 130 were negative, 98 positive for mild or moderate rejection, 23 had a resolving rejection pattern; in 61 cases the patients were treated for acute rejection. Compared to negative biopsies, during acute rejection the QRS voltage and the isovolumic relaxation time significantly decreased, while left ventricular wall thickness and body weight increased. To evaluate the effects of the acute immunosuppressive therapy, the same parameters before and after treatment were compared. The QRS voltage, the wall thickness and the isovolumic relaxation time were significantly modified, returning to the pre-rejection values. In conclusion, both clinical and non-invasive information, may be useful to suspect an episode of acute rejection in heart transplant patients and to program myocardial biopsy.

1989 - [Paroxysmal atrial fibrillation: study of the pattern of onset using dynamic electrocardiography] [Articolo su rivista]
Balducelli, M; Capucci, A; Boriani, G; Magnani, B
abstract

We have examined 24 hours ECG Holter recordings of 22 patients without any organic heart disease and with recurrent episodes of paroxysmal atrial fibrillation (PAF) to check the possible sympatho-vagal influence on spontaneous initiation. Patients were divided into 3 groups according to average heart rate (HR) during the 24 hours recording and to the mode of onset of the arrhythmia: sympathetic (only diurnal episodes, HR greater than or equal to 75 b/min before the onset of the episode, average 24 hours HR greater than or equal to 80 b/min, progressive or sudden shortening of sinusal cycle before the onset), vagal (only nocturnal episodes, HR less than or equal to 60 b/min before the onset, average 24 hours HR less than or equal to 60 b/min, progressive or sudden lengthening of sinusal cycle before the onset of the episode) or "others" who did not show the aforementioned characteristics.

1988 - [Propafenone: evaluation of antiarrhythmic efficacy in hyperkinetic ventricular arrhythmia using acute oral test] [Articolo su rivista]
Boriani, G; Capucci, A; Balducelli, M; Frabetti, L; Marchesini, B; Tomasi, L; Ambrosioni, E; Magnani, B
abstract

N/A

1988 - [Refractory sustained ventricular tachycardia. Electrocardiographic characterization and prognosis] [Articolo su rivista]
Boriani, G; Vecchi, G; Balducelli, M; Capucci, A; Magnani, B
abstract

N/A

1988 - [Role of electrophysiologic study in the sick sinus syndrome and in carotid sinus syndrome] [Articolo su rivista]
Balducelli, M; Boriani, G; Capucci, A; Magnani, B
abstract

N/A

1987 - [Hyperkinetic ventricular arrhythmias in acute myocardial infarction: different etiopathogenetic mechanisms?] [Articolo su rivista]
Capucci, A; Boriani, G; Balducelli, M; Magnani, B
abstract

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