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Roberto SILINGARDI

Professore Associato
Dipartimento di Scienze Biomediche, Metaboliche e Neuroscienze sede ex-Medicina, Endocrinologia, Metabolismo e Geriatria


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Pubblicazioni

2022 - Bridging stent graft fracture after branched endovascular aortic repair in a dual-center retrospective cohort study [Articolo su rivista]
Gennai, S.; Simonte, G.; Migliari, M.; Isernia, G.; Leone, N.; Casali, F.; Farchioni, L.; Lenti, M.; Silingardi, R.
abstract

Objective: Target vessel instability is a relevant complication after thoracoabdominal aortic aneurysms branched endovascular aortic repair (BEVAR). Long-term bridging stent graft (BSG) durability has already been established, but the incidence of long-term complications as component fractures was not deeply investigated. This paper aims to assess BSG fracture incidence and risk factors after BEVAR. Methods: This was a dual-center observational retrospective cohort study. Data of each patient treated with BEVAR between April 2008 and December 2019 were prospectively collected. The primary outcome was the incidence of BSG fracture during follow-up. A logistic regression analysis was performed, including preoperative and postoperative measurements as well as intraoperative details to identify potential risk factors. Results: Two hundred ninety-five target visceral vessels in 91 patients were considered suitable for cannulation. Technical success was 96.9% (286/295 target visceral vessels). The median follow-up was 32.5 months (interquartile range, 14.3-50.1 months). Five BSG fractures (1.75%; 5/286) were detected. Four BSG fractures involved the superior mesenteric artery, and one the celiac trunk. Four different types of fractured stents were detected during follow-up: two Advanta, one BeGraft, one Fluency, and one Viabahn. The median time to BSG fracture was 28.2 months (interquartile range, 11.7-50.8 months). The use of multiple stents (P = .030) and different stent types on the same vessel (P = .004) were associated with BSG fracture at univariable analysis. Using bare-metal stents for distal relining (P = .045) was the only significant factor predisposing to BSG fracture at multiple logistic regression. Conclusions: BSG fracture is a rare but severe complication after BEVAR. It is not related to the stent type used as bridging stent, and it is hardly predictable based on preoperative anatomy. Using multiple and different stents on the same vessel and relining the bridging stents with bare-metal stents may increase BSG fracture risk. A strict computed tomography angiography follow-up remains the best strategy to detect target vessel instability.


2022 - Comparison of long occlusive femoropopliteal de novo versus previous endovascularly treated lesions managed with in situ saphenous bypass [Articolo su rivista]
Troisi, N.; Michelagnoli, S.; Adami, D.; Berchiolli, R.; Accrocca, F.; Amico, A.; Angelini, A.; Arnuzzo, L.; Marchetti, A. A.; Attisani, L.; Bafile, G.; Baldino, G.; Barbanti, E.; Bartoli, S.; Bellosta, R.; Benedetto, F.; Borioni, R.; Briolini, F.; Busoni, C.; Camparini, S.; Cappiello, P.; Carbonari, L.; Casella, F.; Celoria, G.; Chiama, A.; Chisci, E.; Civilini, E.; Codispoti, F.; Conti, B.; Coppi, G.; De Blasis, G.; D'Elia, M.; Di Domenico, R.; Di Girolamo, C.; Ercolini, L.; Ferrari, A.; Ferrari, M.; Forliti, E.; Frigatti, P.; Frigerio, D.; Frosini, P.; Garriboli, L.; Giordano, A. N.; Guerrieri, W.; Jannello, A.; Massara, M.; Merlo, M.; Mezzetti, R.; Miccoli, T.; Milite, D.; Mingazzini, P.; Muncinelli, M.; Nano, G.; Natola, M.; Novali, C.; Palasciano, G.; Perkmann, R.; Persi, F.; Petruccelli, D.; Pinelli, M.; Poletto, G.; Porta, C.; Pratesi, C.; Pruner, G.; Ragazzi, G.; Righini, P.; Salvini, M.; Scovazzi, P.; Setacci, C.; Settembrini, A. M.; Siani, A.; Silingardi, R.; Silvestro, A.; Talarico, F.; Tolva, V.; Trani, A.; Trimarchi, S.; Tshomba, Y.; Vigliotti, G.; Viola, D.; Volpe, P.; Zani, F.
abstract

Background: The aim of this study was to compare the 2-year outcomes of de novo versus postendovascular lesion treatment of femoropopliteal occlusions included in a national, multicenter, observational, prospective registry based on the treatment of critical Limb-threatening IschaeMia with infragenicular Bypass adopting in situ SAphenous VEin technique (LIMBSAVE) registry. Methods: From January 2018 to December 2019, 541 patients from 43 centers have been enrolled in the LIMBSAVE registry. Of these patients, 460 were included in the present study: 341 (74.1%) with de novo lesions (DN group) and 119 (25.9%) with postendovascular treatment lesions (PE group). Initial outcome measures were assessed at 30 days after treatment. Furthermore, at the 2-year follow-up, the estimated outcomes of primary patency, primary-assisted patency, secondary patency, and limb salvage were analyzed with Kaplan-Meier curves and compared between groups with the log-rank test. Results: Both groups were homogeneous in terms of demographic data, preoperative risk factors, and clinical presentation. However, compared with DN group, more patients in PE group had a great saphenous vein diameter of less than 3 mm (11.1% vs 21%; P = .007). Intraoperatively, both groups showed similar distal anastomosis sites: below-the-knee popliteal artery (63% DN group, 66.4% PE group) and tibial vessel (37% DN group, 33.6% PE group) (P = .3). The overall mean duration of follow-up was 11.6 months (range, 1-24 months). At the 2-year follow-up, there were no differences between the two groups in terms of primary patency (66.3% DN group vs 74.1% PE group; P = .9), primary-assisted patency (78.2% DN group vs 79.5% PE group; P = .2), secondary patency (85.1% DN group vs 91.4% PE group; P = .2), and limb salvage (95.2% DN group vs 95.1% PE group; P = .9). Conclusions: The LIMBSAVE registry did not show a worsening of overall patency and limb salvages rates at the 2-year follow-up in patients undergoing in situ saphenous bypass after a failed endovascular approach for long femoropopliteal occlusive disease. This finding is in contrast with what has been published in literature.


2022 - Distal landing zone outcomes in thoracic endovascular aortic aneurysm repair with challenging morphology: a propensity-matched comparison of distal active fixation versus standard stent-graft [Articolo su rivista]
Gennai, S.; Leone, N.; Karelis, A.; Xodo, A.; Mezzetto, L.; Fargion, A.; Antonello, M.; Veraldi, G. F.; Dias, N. V.; Sonesson, B.; Pratesi, C.; Silingardi, R.; Lauricella, A.; Migliari, M.; Andreoli, F.; Bartolotti, L. A.; Scorsone, L.; Mas-Trorilli, D.; Petroni, R.
abstract

Background: To evaluate the distal landing zone (LZ) outcomes in adverse morphology after thoracic endovascular repair (TEVAR) with distal active fixation (DAF) stent-grafts compared with standard endografts. Methods: Between 2006 and the 31st December 2020, sixty-nine DAFs (study group) and sixty-nine standard stent-grafts (control group) were enrolled in a multi-center, retrospective, case-control study. The primary outcomes were the distal endoleak and reintervention. The secondary outcomes were: distal segment migration, wedge apposition and related complications. A univariate and multivariate logistic regression followed by a propensity-scored model (1:1) were performed. Results: The results were reported for the DAF vs. control group. The mean follow-up was 3.3±2.1 vs. 3.7±3.4 years. The distal endoleak rate was 7.3% vs. 27.5% (P=0.011). The freedom from distal endoleak was 95%, 95% and 91% vs. 85%, 76%, and 73% at 1, 3 and 5 years respectively (Log-rank P=0.011). Tortuosity index and distal thoracic aorta angulation were predictors of endoleak (P=0.012 and P=0.029 respectively). The distal reinterventions rate was 7.3% vs. 20.3% (P=0.026). The freedom from distal reinterventions was 95%, 95% and 91% vs. 92%, 75% and 75% at 1, 3 and 5 years respectively (Log-rank P=0.041). The wedge apposition was 5.8 vs. 13.0-mm (P<0.000). The distal segment migration was upward directed in all cases and was significant (>10-mm) in 13.0% vs. 39.1% (P=0.000). Conclusions: The DAF stent-graft showed a significant reduction of the distal endoleak rates and other specific outcomes of the distal LZ in patients with an adverse anatomy.


2022 - Editor's Choice – PRINciples of optimal antithrombotiC therapy and coagulation managEment during elective fenestrated and branched EndovaScular aortic repairS (PRINCE2SS): An International Expert Based Delphi Consensus Study [Articolo su rivista]
D'Oria, M.; Bertoglio, L.; Bignamini, A. A.; Mani, K.; Kolbel, T.; Oderich, G.; Chiesa, R.; Lepidi, S.; Abisi, S.; Adam, D.; Antonello, M.; Austermann, M.; Beck, A. W.; Berard, X.; Bisdas, T.; Bockler, D.; Budtz-Lilly, J.; Cheng, S. W. K.; Czerny, M.; Demartino, R.; Dias, N.; Donas, K. P.; Eagleton, M. J.; Farber, M. A.; Fargion, A. T.; Ferreira, M.; Forbes, T. L.; Gargiulo, M.; Gasper, W. J.; Jakimowicz, T.; Haulon, S.; Hockley, J. A.; Holden, A.; Holt, P.; Kahlberg, A.; Khashram, M.; Kotelis, D.; Lundberg, G.; Maldonado, T. S.; Mangialardi, N.; Mastracci, T. M.; Maurel, B.; Milner, R.; Modarai, B.; Pannuccio, G.; Parlani, G.; Pratesi, G.; Pulli, R.; Qasabian, R. A.; Reijnen, M. M. P. J.; Resh, T.; Riambau, V.; Settembre, N.; Schanzer, A.; Schmidt, A.; Schneider, D.; Schurink, G. W. H.; Silingardi, R.; Sobocinski, J.; Soler, R.; Sweet, M. P.; Leong Tan, G. W.; Tenorio, E. R.; Tielliu, I. F. J.; Timaran, C. H.; Tshomba, Y.; Tsilimparis, N.; Van den Eynde, W.; Vasudevan, T.; Veraldi, G. F.; Verhagen, H. J.; Verhoeven, E.; Verzini, F.; Wanhainen, A.; Zimmermann, A.
abstract

Objective: Management of antithrombotic therapy in patients undergoing elective fenestrated branched endovascular aortic repair (F-BEVAR) is not standardised, nor are there any recommendations from current guidelines. By designing an international expert based Delphi consensus, the study aimed to create recommendations on the pre-, intra-, and post-operative management of antithrombotic therapy in patients scheduled for elective F-BEVAR in high volume centres. Methods: Eight facilitators created appropriate statements regarding the study topic that were voted on, using a four point Likert scale, by a selected panel of international experts using a three round modified Delphi consensus process. Based on the experts’ responses, only those statements reaching Grade A (full agreement ≥ 75%) or B (overall agreement ≥ 80% and full disagreement < 5%) were included in the final document. The round answers’ consistency was graded using Cohen's k, the intraclass correlation coefficient, and, in case of double re-submission, the Fleiss k. Results: Sixty-seven experts were included in the final analysis and voted the initial 43 statements related to pre- (n = 15), intra- (n = 10), and post-operative (n = 18) management of antithrombotic drugs. At the end of the process, six statements (13%) were rejected, 20 statements (44%) received a Grade B consensus, and 18 statements (40%) reached a Grade A consensus. Most statements (27; 71%) exhibited very high or high consistency grades, and 11 (29%) a fair or poor grading. The intra-operative statements mostly concentrated on threshold for and monitoring of proper heparinisation. The pre- and post-operative statements mainly focused on indications for dual antiplatelet therapy and its management, considering the possible need for cerebrospinal fluid drainage. Conclusion: Based on the elevated strength and high consistency of this international expert based Delphi consensus, most of the statements might guide current clinical management of antithrombotic therapy for elective F-BEVAR. Future studies are needed to clarify the debated issues.


2022 - Endoleak outcomes with different stent-graft generations in a 25-years thoracic endovascular aortic repair experience [Articolo su rivista]
Gennai, S.; Leone, N.; Maria Bartolotti, L. A.; Covic, T.; Lauricella, A.; Andreoli, F.; Saitta, G.; Silingardi, R.
abstract

Introduction: To compare endoleak outcomes after thoracic endovascular aneurysm repair (TEVAR) with different stent-graft generations into long-term follow-up. Design: retrospective, observational, and single-center cohort study. Methods: TEVAR procedures performed between November 1995 and December 2020 were analyzed. The primary endpoint of this study was the freedom from endoleak (type I/III) in four stent-graft generations during the follow-up period. The first generation (GEN1) included: Vanguard; AneuRx and Talent; Stentor; Excluder; Endologix; EndoFit. The second generation (GEN2) included: TAG and TX. The third (GEN3) included: Relay Plus; Valiant Captivia; Zenith Alpha and custom-made. The fourth (GEN4) included: Relay Pro; Conformable C-TAG; Navion; E-Vita; Najuta; Nexus; standard and custom-made thoraco-abdominal devices. Nonaortic and aorta-related survival was considered as secondary outcome. Results: A total of 509 TEVAR were included with a 44.3 ± 42.5 months mean follow-up. Freedom from endoleak at 5 years was 65.6%, 61.4%, 76.2%, and 69.1% for GEN1, GEN2, GEN3, and GEN4, respectively (p = 0.368). The first two generations demonstrated a higher endoleak rate when compared with the two most recent ones (27.2 vs 18.2%, respectively; p = 0.043). GEN1 was an independent risk factor (p = 0.014) and GEN4 was an independent protective factor (p = 0.001) for endoleak. GEN1 was found to be a risk factor for type-Ia endoleak (p = 0.059). GEN4 demonstrated a protective association regarding type-Ib endoleak (p = 0.012). Overall survival was 75.3%, 44.4%, 27.2%, and 17.6% at 1, 5, 10, and 15 years, respectively. Survival distinguished as non-related versus aortic-related was 86.7% vs 23.5%, 52.7% vs 9.8%, 32.9% vs 2.0%, 21.2% vs 0% at 1, 5, 10, and 15 years, respectively (p< 0.000). Conclusion: Endoleak occurred in a non-negligible percentage of TEVAR patients. A significant reduction of endoleak incidence over evolving stent-grafts generations was registered. Newer stent-graft generations demonstrated better long-term endoleak. Data about long-term outcomes require ongoing updates to prove both the reliability and the durability of newer stent-graft generations.


2022 - Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study [Articolo su rivista]
de Donato, G.; Pasqui, E.; Sirignano, P.; Talarico, F.; Palasciano, G.; Taurino, M.; Gaggiano, A.; Ferri, M.; Maione, M.; Frola, E.; Tozzi, M.; Piffaretti, G.; Rivolta, N.; Trabattoni, P.; Zoli, S.; Grego, F.; Antonello, M.; Piazza, M.; Frigatti, P.; Borrelli, M. P.; Tusini, N.; Giannace, G.; Silingardi, R.; Andreoli, F.; Ercolini, L.; Ventoruzzo, G.; Mazzitelli, G.; Filippi, F.; Panzano, C.; Credi, G.; Nottoli, J.; Michelagnoli, S.; Chisci, E.; Camparini, S.; Russo, S.; Arzedi, R.; Serra, A.; di Marzo, L.; Mansour, W.; Gattuso, R.; Cuozzo, S.; Ippoliti, A.; Fazzini, S.; Oddi, F. M.; Mangialardi, N.; Orrico, M.; Bartoli, S.; Siani, A.; Ronckey, S.; Barbante, M.; Setteducati, E.; Orlando, P.; Volpe, P.; Massara, M.; Dionisi, C.; Palasciano, G.; Vigliotti, G.; Spinetti, F.; Di Angelo, C.; Modugno, P.; Picone, V.; Farina, A.; Sanfiorenzo, A.; Cappelli, A.; Galzerano, G.; Baldi, C.; Benevento, D.; Alba, G.; Ferrante, G.; Casilli, G.; Gargiulo, B.; Lazzeri, E.; Ferraro, G.; Molino, C.; Pasquetti, L.
abstract

Background: Since 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval. Objective: This registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience. Methods: All consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients' baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint. Results: The study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups. Conclusions: The results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label.


2022 - Multicenter comparison between open conversions and semi-conversions for late endoleaks after endovascular aneurysm repair [Articolo su rivista]
Perini, Paolo; Gargiulo, Mauro; Silingardi, Roberto; Bonardelli, Stefano; Bellosta, Raffaello; Piffaretti, Gabriele; Michelagnoli, Stefano; Tusini, Nicola; Capelli, Patrizio; Turicchia, Giorgio Ubaldo; Freyrie, Antonio
abstract

Objective: The aim of this study is to compare early and follow-up outcomes of late open conversions (LOC, with complete or partial endograft explantation) and semi-conversions (SC, with endograft preservation) after endovascular aneurysm repair in a multicenter experience.Methods: All LOC and SC performed from 1997 to 2020 in 11 vascular centers were compared. Endograft infections or thrombosis were excluded. Primary endpoints were early mortality and long-term survival estimates. Secondary endpoints were differences in postoperative complication rates and conversion-related complications during follow-up.Results: In the considered period, 347 patients underwent surgery for endovascular aneurysm repair complications. Among these, 270 were operated on for endoleaks (222 LOC, 48 SC). The two groups were homogeneous in terms of American Society of Anesthesiologists score (LOC, 3.2 +/- 0.7; SC, 3 +/- 0.5; P = .128) and main endograft characteristics (suprarenal fixation, bifurcated/aorto-uni-iliac configuration). The mean age was 75 +/- 8 years for LOC and 79 +/- 7 years for SC (P= .009). Reasons for LOC were: 62.2% (138/222) type I endoleak, 21.6% (48/222) type II endoleak, 7.7% (17/222) type III endoleak, and 8.5% (19/222) endotension. Indications for SC were: 64.6% (31/48) type II endoleak, 33.3% (16/48) type I endoleak, and 2.1% (1/48) type III endoleak. Thirty-day mortality was 12.2% (27/222) in the LOC group, and 10.4% (5/48) in the SC group (P = .73). Postoperative complication rate was higher in the LOC group (45.5% vs 29.2%; P = .04). The estimated survival rate after LOC was 80% at 1 year and 64% at 5 years; after SC, it was 72% at 1 year and 37% at 5 years (log-rank P= .01). During the median follow-up of 21.5 months (interquartile range, 2.4-61 months), an endoleak after SC was found in the 38.3% of the cases; sac growth was recorded in the 27.7% of SC patients.Conclusions: SC has an early benefit over LOC in terms of reduced postoperative complications but has a significantly inferior mid-term survival. The high rates of persistent and/or recurrent endoleaks reduce SC durability.


2022 - One-year results of the INSIGHT study on endovascular treatment of abdominal aortic aneurysms [Articolo su rivista]
Torsello, G.; Bertoglio, L.; Kellersmann, R.; Wever, J. J.; van Overhagen, H.; Stavroulakis, K.; Becquemin, J. -P.; Buhler, C.; Chiesa, R.; Cieri, E.; Coppi, G.; de Blas, M.; Dias, N.; Ducasse, E.; Garcia, I.; Hamady, M.; Ippoliti, A.; Knippenberg, B.; Kolvenbach, R.; Lakshminarayan, R.; Lorido, A.; Midy, D.; Mosquera, N.; Oberhuber, A.; Pogany, G.; Pratesi, C.; Resch, T.; Riambau, V.; Roos, H.; Philipp Schafer, J.; Scheinert, D.; Silingardi, R.; Sultan, S.; Verzini, F.; Vona, A.; Warle, M.; Wikkeling, M.; Wilkins, J.
abstract

Objective: Endovascular repair of abdominal aortic aneurysms (AAAs) using the INCRAFT AAA Stent Graft System was safe and effective in regulatory approval studies. We herein report on the 1-year results of a real-world clinical study. Methods: The INSIGHT study is a multi-center, prospective, open label, post-approval study conducted to continually evaluate the safety and performance of the INCRAFT System. Between 2015 and 2016, 150 consecutive patients with AAA at 23 centers in Europe were treated with the device in routine clinical practice. The primary endpoint was freedom from major adverse events (MAEs), namely death, myocardial infarction, cerebrovascular accident, and renal failure, within 30 days of the index procedure. End point data were assessed by a core laboratory. The secondary end points included technical success at the conclusion of the procedure and clinical success. Results: All 150 patients studied (mean age, 73.6 ± 8.0 years; 89.3% men) met the primary end point without MAEs at 30-day follow-up. Technical success was achieved in 99.3% of patients without stent fractures at 30 days. Among the 146 patients eligible for 1-year follow-up, the MAE rate was 8.2% (ie, 12 patients suffered 13 MAEs: cerebrovascular accident in 8, myocardial infarction in 1, and 4 died, resulting in a 2.7% all-cause mortality rate). There were no reports of new onset renal failure requiring dialysis. Only 2.7% of patients had type I endoleak, and no type III endoleaks were identified through 1 year. The rate of clinical success at 1 year was 91.8%. Conclusions: The 1-year results of this multicenter real-world study underscore the safety and effectiveness of endovascular treatment of AAA with the INCRAFT System in routine clinical practice.


2022 - Preoperative Risk Factors for Access Site Failure in Ultrasound-Guided Percutaneous Treatment of TASC C and D Aorto-Iliac Occlusive Disease [Articolo su rivista]
Mezzetto, L.; Mastrorilli, D.; Gennai, S.; Silingardi, R.; Bruno, S.; Veraldi, E.; Veraldi, G. F.
abstract

Background: At our institution, we adopted routinely ultrasound guided approach for all percutaneous procedures. The objective of this study was to describe the predictors of access site failures (ASFs) in patients undergoing percutaneous aorto iliac revascularization and to also evaluate whether other factors such as time period or different vascular devices may influence outcomes in terms of ASFs. Methods: We reviewed all consecutive percutaneous revascularizations performed for aortoiliac occlusion or stenosis at our institution from 2011 to 2020. All procedure were performed using an ultrasound (US) guided common femoral access. The primary outcome was ASFs, defined as bleeding or groin hematomas that required transfusions; pseduoaneurysm (diagnosed by US); retroperitoneal hematoma; artery laceration or ruptured (diagnosed intraoperatively); and thrombosis. Multivariable logistic regression was used to determine predictors of ASFs. Results: A total of 502 femoral arteries were accessed under DUS guidance with no failure in sheath placement. Technical success was achieved in 498 of 502 procedures (99.2%). ASFs occurred in 21 patients (7%); but year of procedure appear to be associated with an excess of ASFs as rates were different between the first and second period of the study (10.9% vs. 4.8%, P = 0.04). Results of multivariable logistic regression model indicated that independent predictors of ASFs were common femoral artery (CFA) calcification peripheral artery calcium scoring system (PACCS) grade (odds ratio [OR], 8.7; 95% confidence interval [CI], 5.5–13.7), and CFA diameter (OR, 0.46; 95% CI, 0.25–0.85). Compared to patients with successful percutaneous access, ASFs resulted in longer post-op lengths of stay (P = < 0.001). Conclusion: Percutaneous US guided access can be safely performed in patients undergoing endovascular procedures for aorto iliac revascularization with TASC C and D lesions. CFA calcification PACCS grade greater than 3 and smaller femoral vessel diameter are independent risk factors for ASFs.


2021 - A prognostic risk score for major amputation in dialysis patients with chronic limb-threatening ischemia after endovascular revascularization [Articolo su rivista]
Farchioni, L.; Gennai, S.; Giuliani, E.; Cucci, A.; Lauricella, A.; Leone, N.; Silingardi, R.
abstract

Background: Almost 38% of all patients with end-stage chronic kidney disease (CKD) have peripheral arterial disease of the lower limbs that can lead to chronic limb threatening ischemia (CLTI). The aim of this study was to assess the impact of several factors to conduct a stratification of the amputation risk in CKD patients with CLTI receiving endovascular revascularization. Methods: Observational, retrospective, single-center study of patients treated from 2010 to 2016. The primary endpoint was the major amputation. The study included adult CKD dialysis patients affected by CLTI (rest pain and/or trophic lesions) with indication to endovascular revascularization and excluded for open repair. Results: A total of 82 patients were considered (58 men [70.7%], 24 women [29.3%] mean age 70.4±15.0 years). The number of major amputations was 28 (34.1%). The arterial lesion severity (TASC II-classification) and the trophic lesions extension (WIfI classification) were significantly associated with major amputation (OR and 95%CI, 1.20 [1.07-1.34], P=0.001; 2.65 [1.49-4.72], P=0.001; respectively). Based on the abovementioned characteristics, a prognostic score was proposed to predict the major amputation risk. A score .23 was associated with a 67.6% probability of amputation in the following 12 months. Conclusions: The CLTI revascularization is associated with poor outcomes in CKD patients. The present clinical score provided a pragmatic tool to calculate the major amputation risk. An elevated score could facilitate the decision-making process in order to perform an endovascular treatment vs. conservative approach.


2021 - An International, Multicenter Retrospective Observational Study to Assess Technical Success and Clinical Outcomes of Patients Treated with an Endovascular Aneurysm Sealing Device for Type III Endoleak [Articolo su rivista]
Zoethout, A. C.; Ketting, S.; Zeebregts, C. J.; Apostolou, D.; Mees, B. M. E.; Berg, P.; Beyrouti, H. E.; De Vries, J. -P. P. M.; Torella, F.; Migliari, M.; Silingardi, R.; Reijnen, M. M. P. J.
abstract

Introduction: Type III endoleaks post-endovascular aortic aneurysm repair (EVAR) warrant treatment because they increase pressure within the aneurysm sac leading to increased rupture risk. The treatment may be difficult with regular endovascular devices. Endovascular aneurysm sealing (EVAS) might provide a treatment option for type III endoleaks, especially if located near the flow divider. This study aims to analyze clinical outcomes of EVAS for type III endoleaks after EVAR. Methods: This is an international, retrospective, observational cohort study including data from 8 European institutions. Results: A total of 20 patients were identified of which 80% had a type IIIb endoleak and the remainder (20%) a type IIIa endoleak. The median time between EVAR and EVAS was 49.5 months (28.5–89). Mean AAA diameter prior to EVAS revision was 76.6±19.9 mm. Technical success was achieved in 95%, 1 patient had technical failure due to a postoperative myocardial infarction resulting in death. Mean follow-up was 22.8±15.2 months. During follow-up 1 patient had a type Ia endoleak, and 1 patient had a new type IIIa endoleak at an untreated location. There were 5 patients with aneurysm growth. Five patients underwent AAA-related reinterventions indications being: growth with type II endoleak (n=3), type Ia endoleak (n=1), and iliac aneurysm (n=1). At 1-year follow-up, the freedom from clinical failure was 77.5%, freedom from all-cause mortality 94.7%, freedom from aneurysm-related mortality 95%, and freedom from aneurysm-related reinterventions 93.8%. Conclusion: The EVAS relining can be safely performed to treat type III endoleaks with an acceptable technical success rate, a low 30-day mortality rate and no secondary ruptures at short-term follow-up. The relatively low clinical success rates, related to reinterventions and AAA enlargement, highlight the need for prolonged follow-up.


2021 - Bridging Stents in Fenestrated and Branched Endovascular Aneurysm Repair: A Systematic REVIEW [Articolo su rivista]
Mezzetto, L.; Scorsone, L.; Silingardi, R.; Gennai, S.; Piffaretti, G.; Mantovani, A.; Bush, R. L.; Haulon, S.; Veraldi, G. F.
abstract

Background: Concern exists about durability of stent grafts used to bridge aortic grafts to visceral and renal arteries during fenestrated and branched endovascular aneurysm repair (F/B-EVAR). There are no guidelines regarding the ideal technique for joining target vessels (TVs). Methods: We systematically reviewed data published from 2014 to 2019 using PRISMA guidelines and PICO models. Keywords were searched in MEDLINE, EMBASE, and Cochrane Library. All articles were screened by two authors (a third author in case of discrepancies). Only original articles regarding F/B-EVAR in complex aortic aneurysm, reporting the number and type of TVs mated, the onset of bridging stent complications, and reinterventions on TVs were included. Analysis included quality assessment scoring, types of stent grafts, and complications related to bridging stents. Results: 19 studies were included with 2,796 patients and 9556 TV; 4,797 renal arteries (50.2%), 4,174 visceral arteries (43.6%), and undefined TV (n = 585; 6.1%) were bridged. Balloon-expandable stent-grafts (B-EXP) were used in 40.9% and self-expandable (S-EXP) in 22.7% and undefined stents in 36.3%. The included studies had quality assessment scores ranging between 11/15 and 15/15, with high grade of accordance on reporting general results, but a low grade of accordance on reporting detailed data. Despite study heterogeneity, high-volume analysis confirmed a higher rate of complication in renal arteries than visceral arteries, 6% (95% CI 4–8) vs. 2% (95% CI 1–3), respectively. The rate of reinterventions was similar, 3% (95% CI 2–4) and 2% (95% CI 1–3). S-EXP versus B-EXP stent complication was 4% (95% CI 2–7) vs. 3% (95% CI 2–5), respectively. Conclusions: This systematic review underlines the low grade of accordance in reporting detailed data of bridging stents in F/B-EVAR. Renal TVs were more prone to complications, with an equivalent reintervention rate to visceral TVs. As to B-EVAR, the choice of B-EXP over S-EXP is still uncertain.


2021 - Endovascular occlusion of an aortic coarctation after thoracic endovascular aortic repair of an anastomotic aneurysm [Articolo su rivista]
Covic, T.; Leone, N.; Gennai, S.; Silingardi, R.
abstract

A 58-year-old man with a history of aortic and mitral mechanical valve replacement was referred to our hospital for symptomatic chronic heart failure. In 1988, he had undergone open surgical correction of an isthmic aortic coarctation (CoA), with the creation of an extra-anatomic bypass from the left subclavian artery to the descending thoracic aorta. The following findings were found: severe mitral valve failure with perivalvular leakage, severe aortic valve stenosis, pulmonary hypertension, distal anastomotic aneurysm with the apparent occlusion of the CoA. A thoracic endovascular aneurysm repair was performed. A postoperative high-pressure leak with no evident signs of ineffective sealing was observed. Computed tomography angiography (CTA) 3D reconstruction demonstrated the recanalization of the CoA. A second procedure was planned. The CoA was anterogradely cannulated. Three coils were deployed into the aneurysmal sac, followed by a vascular plug, positioned on the coarctation conduit, but it failed to anchor and dislocated into the sac. A second plug was deployed, but it also partially dislocated. Finally, a patent foramen ovale occluder device was deployed to occlude the communication. The final angiogram showed the complete occlusion of the coarctation and correction of the leak, which was confirmed by a 6-month post-operative CTA.


2021 - Evaluation of Clinical Outcomes After Revascularization in Patients With Chronic Limb-Threatening Ischemia: Results From a Prospective National Cohort Study (RIVALUTANDO) [Articolo su rivista]
de Donato, G.; Benedetto, F.; Stilo, F.; Chiesa, R.; Palombo, D.; Pasqui, E.; Panzano, C.; Pulli, R.; Novali, C.; Silingardi, R.; Grego, F.; Palasciano, G.; Setacci, C.; Pulli, R.; Angiletta, G.; Delia, S.; Novali, C.; Rivellini, C.; Palombo, B.; Pane, B.; Spinella, G.; Benedetto, F.; Pipito, N.; Spinelli, D.; Derone, G.; Chiesa, R.; Tshomba, Y.; Cilli, G.; Silingardi, R.; Lauricella, A.; Maresca, L.; Grego, F.; Antonello, M.; Piazza, M.; Bonvini, S.; Wassermann, V.; Trani, A.; Barresi, A.; Licitra, G.; Spinelli, F.; Stilo, F.; Montelione, N.; Paroni, G.; Magistro, G.; Ceriello, D.; Merlo, M.; Giordano, F.; de Donato, G.; Pasqui, E.; Panzano, C.; Ruzzi, U.; Mazzitelli, G.; Mele, M.; Giannace, G.; Alba, G.; Grottola, G.; Pazzaglia, M.; Giubbolini, G.; Baldi, B.; Guerrieri, W.; Benevento, D.; Cappelli, A.; Palasciano, G.; Setacci, C.; Kahlberg, A.; Carta, N.
abstract

We evaluated the outcomes of revascularization in patients with chronic limb-threatening ischemia (CLTI) treated in real-world settings. This is a prospective multicenter cohort study with 12-month follow-up enrolling patients (n = 287) with CLTI undergoing open, endovascular, or hybrid lower extremity revascularization. The primary end point was amputation-free survival (AFS) at 12 months. Cox proportional analysis was used to determine independent predictors of amputation and restenosis. At 30 days, major adverse cardiovascular and major adverse limb events (MALE) rates were 3.1% and 2.1%, respectively. At 1 year, the overall survival rate was 88.8%, the AFS was 86.6%, and the primary patency was 70.5%. Freedom from MALE was 62.5%. After multivariate analysis, smoking (hazard ratio [HR] = 2.2, P = 0.04), renal failure (HR = 2.3, P = 0.03), Rutherford class (≥5) (HR = 3.2, P = 0.01), and below-the-knee disease (HR = 2.0, P = 0.05) were significant predictors of amputation; iloprost infusion (>10 vials) (HR = 0.64, P = 0.05) was a significant protective factor. Cilostazol administration (HR = 0.77, P = 0.05) was a significant protective factor for restenosis. Results from this prospective multicenter registry offer a consistent overview of clinical outcomes of CLTI patients at 1 year when adequately revascularized. Medical treatment, including statins, cilostazol and iloprost, were associated with improved 1-year freedom from restenosis and amputation.


2021 - Health-related quality of life outcomes and hospitalization length of stay after micro-fragmented autologous adipose tissue injection in minor amputations for diabetic foot ulceration (MiFrAADiF Trial): Results from a randomized controlled single-center clinical trial [Articolo su rivista]
Gennai, S.; Leone, N.; Covic, T.; Migliari, M.; Lonardi, R.; Silingardi, R.
abstract

Background: The diabetic foot ulcer (DFU) is a high prevalence complication that significantly impairs the health-related quality of life (HRQoL) and is characterized by prolonged hospital length of stay (LOS). The impact of the micro-fragmented autologous adipose tissue injection at the minor amputation wound in the case of DFU (MiFrAADiF) on HRQoL and LOS compared to the standard care has not been determined yet. Methods: This was a two-arm, 6-month, individually-randomized controlled single-center clinical trial. A 1:1 randomization to local injection of autologous micro-fragmented adipose tissue (treatment group; N.=57) or standard clinical care (control group; N.=57) was performed. The primary objective was the HRQoL. The secondary endpoint was the LOS. HRQoL was assessed with the Medical Outcomes Study 36-item Short-Form Health Survey which provides 2 scores focused on physical (PCS) and mental functioning (MCS). The trial was registered in ClinicalTrials.gov (NCT03276312). Results: The type of treatment (P=0.009) and the time elapsed since surgery (P=0.0000) demonstrated a significant improvement on PCS. The MCS improvements resulted in a non-significant association with treatment (P=0.21). The time elapsed since surgery showed a significant influence on the MCS (P=0.0000). The mean LOS was 16.2 days and 24.4 days for the treatment and the control group respectively (P=0.025). Conclusions: The MiFrAADiF Trial demonstrated a significant improvement in terms of physical HRQoL and a significant reduction of the hospital length of stay after injection of micro-fragmented autologous adipose tissue in diabetic patients' minor amputations wound.


2021 - Intravascular Ultrasound in Branched and Fenestrated Endovascular Aneurysm Repair: Initial Experience in a Single-Center Cohort Study [Articolo su rivista]
Gennai, S.; Leone, N.; Saitta, G.; Migliari, M.; Lauricella, A.; Farchioni, L.; Silingardi, R.
abstract

Purpose: To evaluate intravascular ultrasound (IVUS) safety and efficacy to detect visceral stenting issues during complex endovascular aneurysm repair through branched and fenestrated repair (B-FEVAR). Materials and Methods: A single-center retrospective analysis of 33 bridging stents assessed intraoperatively using IVUS between January and September 2020 was performed. Ten aortic aneurysm patients [7 thoracoabdominal / 1 pararenal / 2 juxtarenal; 3 females; mean age 73 years [range 70–77 years]) were included. Eight BEVAR (5 standard; 2 custom-made) and 2 FEVAR (custom-made) were performed. The study assessed the safety and efficacy of IVUS utilization to detect immediate branch instability after visceral stenting in the case of B-FEVAR. The primary safety endpoint was defined as the absence of IVUS-related adverse events. The primary efficacy endpoint was defined as the composite of technical success of the IVUS-assessment in each target visceral vessels (TVVs), the rate of IVUS-findings divided as prompting additional maneuvers or not, and the incidence of postoperative computed tomography angiography findings compared with intraoperative assessment. Results: There were no IVUS-related adverse events. The technical success of the IVUS-assessment was achieved in all TVVs. No technical issues compromised the evaluation of the intended vessel. Among the 7 findings identified by IVUS, 3 were suspected at the angiography. In all, 57% (4/7) had normal final angiography. IVUS was able to detect a 12% (4/33) intraoperative branch instability not identified/suspected at the completion angiography. The IVUS assessment led to an immediate revision in 5 (15%) vessels. A total of 57% (4/7) of the issues were detected in patients undergoing primary BEVAR. The remaining 43% (3/7) was detected in patients undergoing secondary intervention for branch instability. Conclusion: IVUS was safe as an adjunctive imaging technique to assess completion after B-FEVAR. It demonstrated efficacy in the detection of intraoperative issues missed by angiography. Further investigations are required to validate these promising results.


2021 - Outcome of Endovascular Repair of Popliteal Artery Aneurysms using the Supera Stent [Articolo su rivista]
Lauricella, A.; Gennai, S.; Covic, T.; Leone, N.; Migliari, M.; Andreoli, F.; Silingardi, R.
abstract

Purpose: To evaluate the efficacy of endovascular repair of popliteal artery aneurysms (PAAs) with a wire-interwoven nitinol stent. Materials and Methods: This is a prospective, descriptive, and analytical study. From January 2016 to December 2018, 28 consecutive patients (29 lower limbs) were treated for a PAA with the deployment of the Supera stent (Abbott Vascular, Illinois). Twenty-three (79.3%) PAAs were asymptomatic; 6 (20.7%) presented with symptoms. The mean diameter and length of the aneurysm were 26.8 mm (20–40 mm) and 47.1 mm (23–145 mm) respectively. The primary endpoint was the prevention of embolic symptoms. The secondary endpoints were aneurysm exclusion, aneurysm diameter decrease, freedom from reintervention, and preservation of preoperative runoff vessels. Results: Technical success was 100%, with a median of 2.4 run-off vessels at completion angiography, without any loss of run-off vessels. A double Supera stent was deployed in 10 cases. At completion angiography, a median of 2.4 runoff vessels were present, without any loss of runoff vessels. The mean follow-up time was 24.3 (12–35) months. Primary endpoints were reached in 100% of the cases and vessels run off was preserved in all cases. In 2 PAAs, complete sac thrombosis was witnessed at 6-month follow-up, while at 12-month follow-up, it was seen in 10 of 29 (34.4%) limbs. In all the other cases the diameter of the aneurysm remained stable, with a freedom from sac enlargement of 100%. No fractures or stent thromboses were detected. Conclusions: For endovascular repair of PAAs, the use of a thick interwoven-wire stent, that could work like a multilayer flow modulator showed encouraging mid-term results with no cases of stent fracture, occlusion or aneurysm increase.


2021 - Preliminary Outcomes of Viabahn Balloon-Expandable Endoprosthesis as Bridging Stent in Renal Arteries During Fenestrated Endovascular Aortic Repair [Articolo su rivista]
Mezzetto, L.; Mastrorilli, D.; Leone, N.; Gennai, S.; Silingardi, R.; Veraldi, G. F.; Piazza, M.; Squizzato, F.; Antonello, M.
abstract

Purpose: To report preliminary outcomes of Viabahn Balloon-Expandable Endoprosthesis (VBX) stent-graft as bridging stent for renal arteries in fenestrated endovascular aneurysm repair (FEVAR). Materials and Methods: Between 2018 and 2019, patients undergoing FEVAR at 3 referral Italian university hospitals were prospectively collected. During the study period, VBX was the first-line choice as bridging stent for renal arteries. Procedural and anatomical data were analyzed, including renal artery (RA) configuration. A dedicated software (3Mensio, Vascular Imaging, Bilthoeven, The Netherlands) was used and RA anatomy classified as follow: upward-oriented in case of any angle >30° above the horizontal or transverse axis perpendicular to the aortic axis, downward-oriented if there was an angle >30° measured below the transverse axis and downward + upward in case of an angle <30° associated with a renal artery angulation >90°. Primary endpoints were technical success, defined as complete deployment of the fenestrated endograft without target vessel (TV) loss, limb stenosis or occlusion and type I or III endoleak, and freedom from target artery instability (TAI), defined by target vessel-related death, occlusion, rupture or reintervention for stenosis, endoleak or disconnection. Secondary endpoints were target artery patency rate and freedom from reinterventions. Results: A total of 26 elective FEVAR for juxta/pararenal aneurysm (20), thoracoabdominal type II (3) and type IV (3) were included. Fifty-one RA were planned for revascularization. Of these, 32 were downward, 10 horizontal, 6 upward, 4 were downward + upward. Technical success was achieved in 88.5% (23/26) of patients and 94.2% (48/51) of the TVs. One occlusion (2.1%) occurred within 30 days in a patient with previous endovascular aortic repair and suprarenal fixation. During follow-up (median 10 months), there was 1 type IC endoleak after 6 months (2.1%) in a patient with upward plus downward arterial orientation. Freedom from TAI was 96.1% (CI = 0.89 to 1.04) at first month and 92.3% (CI = 0.82 to 1.03) at 6 months. No aneurysm-related mortality and renal insufficiency occurred during follow-up. Conclusion: The use of VBX as bridging stent of RA in FEVAR is safe and feasible. Previous EVAR and tortuosity of RA may be a challenging on target vessel fate.


2021 - Preliminary six-month outcomes of LIMBSAVE (treatment of critical Limb IscheMia with infragenicular Bypass adopting in situ SAphenous VEin technique) registry [Articolo su rivista]
Troisi, N.; Blasis, G. D.; Salvini, M.; Michelagnoli, S.; Setacci, C.; Accrocca, F.; Adami, D.; Angelini, A.; Arnuzzo, L.; Ascoli Marchetti, A.; Attisani, L.; Bafile, G.; Baldino, G.; Barbanti, E.; Bartoli, S.; Bellosta, R.; Benedetto, F.; Borioni, R.; Briolini, F.; Busoni, C.; Camparini, S.; Cappiello, P.; Carbonari, L.; Casella, F.; Celoria, G.; Chisci, E.; Civilini, E.; Codispoti, F.; Conti, B.; Coppi, G.; D'Amico, A.; De Blasis, G.; D'Elia, M.; Di Domenico, R.; Di Girolamo, C.; Ercolini, L.; Ferrari, A.; Ferrari, M.; Forliti, E.; Frigatti, P.; Frigerio, D.; Frosini, P.; Garriboli, L.; Nicola Giordano, A.; Guerrieri, W.; Jannello, A.; Massara, M.; Merlo, M.; Mezzetti, R.; Miccoli, T.; Michelagnoli, S.; Milite, D.; Mingazzini, P.; Muncinelli, M.; Nano, G.; Natola, M.; Novali, C.; Palasciano, G.; Perkmann, R.; Persi, F.; Petruccelli, D.; Pinelli, M.; Poletto, G.; Porta, C.; Pratesi, C.; Pruner, G.; Ragazzi, G.; Righini, P.; Salvini, M.; Scovazzi, P.; Setacci, C.; Maria Settembrini, A.; Siani, A.; Silingardi, R.; Silvestro, A.; Talarico, F.; Tolva, V.; Trani, A.; Trimarchi, S.; Tshomba, Y.; Vigliotti, G.; Viola, D.; Volpe, P.; Zani, F.
abstract

Objectives: Guidelines recommend open bypass surgery for long occlusions of infrainguinal arteries. In situ saphenous vein bypass is a standardized technique. The aim of this study was to report preliminary six-month outcomes of a national, multicenter, observational, prospective registry based on the examination of treatment of critical Limb IscheMia with infragenicular Bypass adopting the in situ SAphenous VEin technique (LIMBSAVE). Methods: From January 2018 until October 2019, 428 patients from 41 centers were enrolled in the LIMBSAVE registry. Data were prospectively collected in a dedicated database, including demographics, preoperative risk factors, clinical and diagnostic preoperative assessments, intraoperative measures (including safety and effectiveness of the valvulotome during the surgical procedures), and 30-day follow-up data. Furthermore, estimated six-month outcomes according to Kaplan–Meier curves in terms of primary patency, primary assisted patency, secondary patency, and limb salvage were evaluated. Results: Patients were predominantly male (n = 332, 77.6%) with a mean age of 73.3 years (range 39–95). Technical success, defined as bypass pulse after use of the valvulotome, was obtained in all cases. The proximal anastomosis could be reached by the valvulotome in all cases. The mean number of valvulotome uses was 2.5 (range 1–5). No vein perforation was reported. In nine cases (2.1%), a vein lesion with intramural hemorrhage occurred. The mean length of hospital stay was 11.1 days (range 1–60). At 30-day follow-up, the overall bypass patency rate was 97.4%, and the rate of open or endo reinterventions for failing bypass was 5.4%. At six-month follow-up, the estimated primary patency, primary assisted patency, secondary patency, and limb salvage were 78.1%, 86.2%, 92.1%, and 94.7%, respectively. Conclusions: Preliminary intraprocedural outcomes of the LIMBSAVE registry show that the in situ technique with the valvulotome is safe and effective in disrupting valves and obtaining pulsatility in the saphenous vein. The complication rate related to the use of the valvulotome is low. The six-month preliminary outcomes in terms of overall patency and limb salvage are promising. Further examinations and continuous follow-up are needed to evaluate long-term outcomes.


2021 - Safety and Efficacy of Vacuum Assisted Thrombo-Aspiration in Patients with Acute Lower Limb Ischaemia: The INDIAN Trial [Articolo su rivista]
de Donato, G.; Pasqui, E.; Sponza, M.; Intrieri, F.; Spinazzola, A.; Silingardi, R.; Guzzardi, G.; Ruffino, M. A.; Palasciano, G.; Setacci, C.; Jannello, A.; Bonera, G.; Ronchey, S.; Siani, A.; Lenti, M.; Moramarco, L.; Pulli, R.; Speziale, F.; Santuari, D.
abstract

Objective: The aim was to evaluate the short term safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischaemia. (ALLI). Recently, endovascular vacuum assisted thrombectomy devices, similar to those used in the management of acute ischaemic stroke, have become available for peripheral arteries, but data are still scarce. Methods: To assess vessel patency, a modified Thrombolysis in Myocardial Infarction (TIMI) classification, called TIPI (Thrombo-aspiration In Peripheral Ischaemia), is proposed. The TIPI flow is assessed at presentation, immediately after treatment with the study device, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularisation TIPI 2 – 3. Safety and clinical success rate were collected at one month. Results: One hundred and fifty patients were enrolled. The mean age was 72.4 years and 73.3% were male. Rutherford grade on enrolment was I in 16%, IIa in 40.7%, and IIb in 43.3% with a mean ankle brachial index of 0.19. Primary technical success (TIPI 2 – 3 flow) was achieved in 88.7% of patients. Adjunctive procedures included angioplasty/stenting of chronic atherosclerotic lesions (n = 39), thrombolysis (n = 31), covered stenting (n = 15), and supplementary Fogarty embolectomy (n = 6). After all interventions, assisted primary technical success was 95.3% (TIPI 2 – 3 in 143/150). No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, one death, and one below the knee amputation were recorded. Primary patency was 92% (138/150), and the re-intervention rate was 7.33%, resulting in an assisted primary and secondary patency of 94% and 99.33%, respectively. Conclusion: Results from the INDIAN registry reveal that mechanical thrombectomy using the Indigo system is safe and effective for revascularisation of ALLI as a primary therapy.


2021 - Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy [Articolo su rivista]
Halliday, A.; Bulbulia, R.; Bonati, L. H.; Chester, J.; Cradduck-Bamford, A.; Peto, R.; Pan, H.; Potter, J.; Henning Eckstein, H.; Farrell, B.; Flather, M.; Mansfield, A.; Mihaylova, B.; Rahimi, K.; Simpson, D.; Thomas, D.; Sandercock, P.; Gray, R.; Molyneux, A.; Shearman, C. P.; Rothwell, P.; Belli, A.; Herrington, W.; Judge, P.; Leopold, P.; Mafham, M.; Gough, M.; Cao, P.; Macdonald, S.; Bari, V.; Berry, C.; Bradshaw, S.; Brudlo, W.; Clarke, A.; Cox, R.; Fathers, S.; Gaba, K.; Gray, M.; Hayter, E.; Holliday, C.; Kurien, R.; Lay, M.; le Conte, S.; Mcmanus, J.; Madgwick, Z.; Morris, D.; Munday, A.; Pickworth, S.; Ostasz, W.; Poorthuis, M.; Richards, S.; Teixeira, L.; Tochlin, S.; Tully, L.; Wallis, C.; Willet, M.; Young, A.; Casana, R.; Malloggi, C.; Odero, A.; Silani, V.; Parati, G.; Malchiodi, G.; Malferrari, G.; Strozzi, F.; Tusini, N.; Vecchiati, E.; Coppi, G.; Lauricella, A.; Moratto, R.; Silingardi, R.; Veronesi, J.; Zini, A.; Ferrero, E.; Ferri, M.; Gaggiano, A.; Labate, C.; Nessi, F.; Psacharopulo, D.; Viazzo, A.; Malacrida, G.; Mazzaccaro, D.; Meola, G.; Modafferi, A.; Nano, G.; Occhiuto, M. T.; Righini, P.; Stegher, S.; Chiarandini, S.; Griselli, F.; Lepidi, S.; Pozzi Mucelli, F.; Naccarato, M.; D'Oria, M.; Ziani, B.; Stella, A.; Dieng, M.; Faggioli, G.; Gargiulo, M.; Palermo, S.; Pini, R.; Puddu, G. M.; Vacirca, A.; Angiletta, D.; Desantis, C.; Marinazzo, D.; Mastrangelo, G.; Regina, G.; Pulli, R.; Bianchi, P.; Cireni, L.; Coppi, E.; Pizzirusso, R.; Scalise, F.; Sorropago, G.; Tolva, V.; Caso, V.; Cieri, E.; Derango, P.; Farchioni, L.; Isernia, G.; Lenti, M.; Parlani, G. B.; Pupo, G.; Pula, G.; Simonte, G.; Verzini, F.; Carimati, F.; Delodovici, M. L.; Fontana, F.; Piffaretti, G.; Tozzi, M.; Civilini, E.; Poletto, G.; Reimers, B.; Praquin, B.; Ronchey, S.; Capoccia, L.; Mansour, W.; Sbarigia, E.; Speziale, F.; Sirignano, P.; Toni, D.; Galeotti, R.; Gasbarro, V.; Mascoli, F.; Rocca, T.; Tsolaki, E.; Bernardini, G.; Demarco, E.; Giaquinta, A.; Patti, F.; Veroux, M.; Veroux, P.; Virgilio, C.; Mangialardi, N.; Orrico, M.; Di Lazzaro, V.; Montelione, N.; Spinelli, F.; Stilo, F.; Cernetti, C.; Irsara, S.; Maccarrone, G.; Tonello, D.; Visona, A.; Zalunardo, B.; Chisci, E.; Michelagnoli, S.; Troisi, N.; Masato, M.; Dei Negri, M.; Pacchioni, A.; Sacca, S.; Amatucci, G.; Cannizzaro, A.; Accrocca, F.; Ambrogi, C.; Barbazza, R.; Marcucci, G.; Siani, A.; Bajardi, G.; Savettieri, G.; Argentieri, A.; Corbetta, R.; Odero, A.; Quaretti, P.; Thyrion, F. Z.; Cappelli, A.; Benevento, D.; De Donato, G.; Mele, M. A.; Palasciano, G.; Pieragalli, D.; Rossi, A.; Setacci, C.; Setacci, F.; Palombo, D.; Perfumo, M. C.; Martelli, E.; Paolucci, A.; Trimarchi, S.; Grassi, V.; Grimaldi, L.; La Rosa, G.; Mirabella, D.; Scialabba, M.; Sichel, L.; D'Angelo, C. L.; Fadda, G. F.; Kasemi, H.; Marino, M.; Burzotta, F.; Codispoti, F. A.; Ferrante, A.; Tinelli, G.; Tshomba, Y.; Vincenzoni, C.; Amis, D.; Anderson, D.; Catterson, M.; Clarke, M.; Davis, M.; Dixit, A.; Dyker, A.; Ford, G.; Jackson, R.; Kappadath, S.; Lambert, D.; Lees, T.; Louw, S.; Mccaslin, J.; Parr, N.; Robson, R.; Stansby, G.; Wales, L.; Wealleans, V.; Wilson, L.; Wyatt, M.; Baht, H.; Balogun, I.; Burger, I.; Cosier, T.; Cowie, L.; Gunathilagan, G.; Hargroves, D.; Insall, R.; Jones, S.; Rudenko, H.; Schumacher, N.; Senaratne, J.; Thomas, G.; Thomson, A.; Webb, T.; Brown, E.; Esisi, B.; Mehrzad, A.; Macsweeney, S.; Mcconachie, N.; Southam, A.; Sunman, W.; Abdul-Hamiq, A.; Bryce, J.; Chetter, I.; Ettles, D.; Lakshminarayan, R.; Mitchelson, K.; Rhymes, C.; Robinson, G.; Scott, P.; Vickers, A.; Ashleigh, R.; Butterfield, S.; Gamble, E.; Ghosh, J.; Mccollum, C. N.; Welch, M.; Welsh, S.; Wolowczyk, L.; Donnelly, M.; D'Souza, S.; Egun, A. A.; Gregary, B.; Joseph, T.; Kelly, C.; Punekar, S.; Rahi, M. A.; Raj, S.; Seriki, D.; Thomson, G.; Brown, J.; Durairajan, R.; Grunwald, I.; Guyler, P.; Harman, P.; Jakeways, M.; Khuoge, C.; Kundu, A.; Loganathan, T.; Menon, N.; Prabakaran, R. O.; Sinha, D.; Tho
abstract

Background: Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods: ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings: Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation: Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding: UK Medical Research Council and Health Technology Assessment Programme.


2021 - Two Decades of Abdominal Aortic Endovascular Repair With the Anatomical FiXation at the Aortic Bifurcation in a Large Single-Center Experience [Articolo su rivista]
Gennai, S.; Andreoli, F.; Saitta, G.; Leone, N.; Migliari, M.; Covic, T.; Silingardi, R.
abstract

Objective: The introduction of new endograft models improved long-term results of abdominal aortic aneurysm (AAA) endovascular repair (EVAR), but most of them maintained an old and unchanged design: a short body and long legs shifting up the flow divider. This study assessed the long-term results of EVAR with unimodular endoprosthesis fixed at the aorto-iliac bifurcation (Anatomical FiXation), in a large, unselected cohort. Materials and Methods: In a single-center, retrospective cohort study, 623 patients selectively treated between 1999 and 2016, were analyzed. Follow-up protocol included at least a computed tomography angiography within 3 months and a duplex ultrasound and clinical exam yearly. All enrolled patients were analyzed by 2020. The primary outcomes were technical success, clinical success, and survival. Secondary outcomes included survival-free from late-open-conversion (LOC), reintervention, and endoleaks. Results: Median age was 74±11 years and the follow-up 93±54 months. The technical success was achieved in 99.4% and the 30-day clinical success was 98.4%. A 5-year clinical success of 97.7% was registered and at 10 years success was 96.7%. The overall survival at 1, 5, 10, and 15 years was 92.4%, 79.5%, 64.9%, and 45.5%, respectively. Six (0.98%) AAA-related death were registered, 3 caused by infection of the endograft and 3 for secondary rupture. LOCs were 9 (1.47%) and reintervention-free survival at 1, 5, 10, and 15 years were 88.4%, 78.0%, 76.2%, and 74.6%, respectively. Freedom from endoleaks was 88.8% at 1 year and 72.7% at 15 years. A total of 63 high-flow endoleaks were registered (43 type I, 7 type IIIa, 12 type IIIb, and 1 type Ib+IIIb). No migrations were recorded, and the graft limb thrombosis rate was 1.14%. From a multivariate analysis resulted that long-term clinical success appeared to be reduced in patients affected by diabetes [odds ratio (OR) 0.24; p=0.04] and in presence of calcified and thrombotic iliac accesses (OR 0.16; p=0.006). Conclusion: EVAR with the Anatomical FiXation was confirmed to be safe, feasible, and effective to prevent AAA rupture in the long term as well. However, the overall survival remains afflicted by cardiovascular accident. The original concept of unibody bifurcated design allowed a very low rate of graft thrombosis and zeroed the risk of migration and related reintervention.


2021 - Unibody bifurcated aortic endograft: Device description, review of the literature and future perspectives [Articolo su rivista]
Sirignano, P.; Silingardi, R.; Mansour, W.; Andreoli, F.; Migliari, M.; Speziale, F.
abstract

The unibody (Powerlink/AFX/AFX2) Endovascular AAA device (Endologix Inc., CA, USA) presents a unique design with its long main body and two innate limbs. The device is designed to be deployed and sits on the native aortoiliac bifurcation and represents the only one-piece bifurcated endograft designed to use anatomical fixation for endograft stabilization. According to published literature, the unibody device seems to represent a valid choice in the treatment of abdominal aortic aneurysms. This particular device would seem to satisfactorily perform even in the treatment of more compressed aneurysms (also in off-label association with parallel grafts) and in occlusive pathologies. Ongoing studies will provide new real-life data in a large and unselected patient population to better understand the device's advantages and limitations.


2021 - Visceral and renal artery aneurysms [Monografia/Trattato scientifico]
Silingardi, Roberto; Gennai, Stefano
abstract


2020 - Acute limb ischemia in COVID-19 patients: Could aortic floating thrombus be the source of embolic complications? [Articolo su rivista]
Silingardi, R.; Gennai, S.; Migliari, M.; Covic, T.; Leone, N.
abstract


2020 - Early and Long-term Results of ePTFE (Gore TAG®) versus Dacron (Relay Plus® Bolton) Grafts in Thoracic Endovascular Aneurysm Repair [Articolo su rivista]
Luca, M.; Lorenzo, S.; Silingardi, R.; Stefano, G.; Nicola, L.; Gabriele, P.; Franco, V. G.
abstract

Background: The aim of this study is to compare early and late results of an expanded polytetrafluoroethylene (ePTFE—Gore TAG®, group A) mesh structured endograft versus a Dacron one (Relay Plus® Bolton, group B) in thoracic endovascular aneurysm repair (TEVAR). Methods: A prospective database was used to extract information from anonymous patients who underwent TEVAR for descending thoracic aortic aneurysms (DTAAs) between February 2005 and February 2019 at 3 referral university hospitals. Cases treated by means of ePTFE endograft (Gore TAG, group A) and Dacron graft (Relay Plus Bolton, group B) in elective and urgent settings were included. Early and late outcomes were compared. Results: A total of 129 consecutive patients were included (115 men and 14 women). ePTFE—Gore TAG® and Dacron—Relay Plus® Bolton were used in 56 (43.4%) and 73 (56.5%) patients, respectively. Preoperative characteristics of patients were similar. Technical success was 100%. Urgent procedures were 22.4%. Mean aortic coverage and partial debranching were 217.5 ± 91.3 and 37.2%, respectively. Early mortality and spinal cord ischemia (SCI) were 8.5% and 2.3%, respectively, without differences between the 2 groups. Early reintervention was required in 5.4% (group A) and 11% (group B), P = 0.29. Median follow-up was 32 months (interquartile range 12–55 months, range 1–156 months), similar between the 2 groups. Type I endoleak (EL), type II EL, and type III EL were observed in 16.3%, 10.9%, and 3.1% of cases, respectively, without significant differences between the groups. The rate of sac shrinkage was 28.6% in group A vs. 39.7% in group B (P = 0.19). Freedom from reintervention in group A versus group B at 6, 12, 24, and 36 months was 94.0% vs. 97.1%, 94.0% vs. 95.5%, 90.8% vs. 86.9%, and 81.1% vs. 80.4%, respectively (log-rank 0.35, Breslow 0.54). Rate of survival at 6, 12, 24, and 36 months was 96.0% vs. 94.2%, 89.3% vs. 86.8%, 76.5% vs. 77.5%, and 63.3% vs. 64.2%, respectively (log-rank 0.30, Breslow 0.57). Conclusions: ePTFE—Gore TAG and Dacron—Relay Plus Bolton in DTAA presented similar early and late results in terms of mortality, SCI, EL, and TEVAR-related reinterventions. Effectiveness of TEVAR procedure was confirmed by the high rate of sac shrinkage and it was not influenced by endograft fabric.


2020 - Erratum: Unibody endograft using AFX 2 for less invasive and faster endovascular aortic repair: Protocol for a multicenter nonrandomized study (JMIR Research Protocols (2020) 9:4 (e16959) DOI: 10.2196/16959) [Articolo su rivista]
Silingardi, R.; Sirignano, P.; Andreoli, F.; Mansour, W.; Migliari, M.; Speziale, F.
abstract

In “Unibody Endograft Using AFX 2 for Less Invasive and Faster Endovascular Aortic Repair: Protocol for a Multicenter Nonrandomized Study” (JMIR Res Protoc 2020;9(4):e16959) there were two errors in the Collaborators List. The collaborator Sonia Ronchey was inadvertently not included in the collaborator list. Additionally, the collaborator name Pietro Volpet should have been listed as Pietro Volpe. The Collaborator List was initially published as follows: The LIVE Study Collaborators are as follows: Giancarlo Accarino; Dimitri Apostolou; Guido Bajardi; Stefano Bartoli; Filippo Benedetto; Franco Briolini; Stefano Camparini; Emidio Costantini; Giovanni Credi; Ruggiero Curci; Raffaello Dallatana; Gianmarco de Donato; Carlo Dionisi; Vittorio Dorrucci; Leonardo Ercolini; Gianfranco Fadda; Mauro Ferrari; Loris Flora; Andrea Gaggiano; Roberto Gattuso; Franco Grego; Sabrina Grimaldi; Giovanni Impedovo; Arnaldo Ippoliti; Antonio Jannello; Sergio Losa; Nicola Mangialardi; Isaac Martinez; Javier Martinez; Stefano Michelagnoli; Giancarlo Palasciano; Vincenzo Palazzo; Domenico Palombo; Raffaele Pulli; Giovanni Rossi; Antonino Scolaro; Gianantonio Simoni; Francesco Spinelli; Francesco Talarico; Maurizio Taurino; Marco Trogolo; Nicola Tusini; Gianfranco Veraldi; Pier Francesco Veroux; Gennaro Vigliotti; and Pietro Volpet. The Collaborator List has now been updated to the following: The LIVE Study Collaborators are as follows: Giancarlo Accarino; Dimitri Apostolou; Guido Bajardi; Stefano Bartoli; Filippo Benedetto; Franco Briolini; Stefano Camparini; Emidio Costantini; Giovanni Credi; Ruggiero Curci; Raffaello Dallatana; Gianmarco de Donato; Carlo Dionisi; Vittorio Dorrucci; Leonardo Ercolini; Gianfranco Fadda; Mauro Ferrari; Loris Flora; Andrea Gaggiano; Roberto Gattuso; Franco Grego; Sabrina Grimaldi; Giovanni Impedovo; Arnaldo Ippoliti; Antonio Jannello; Sergio Losa; Nicola Mangialardi; Isaac Martinez; Javier Martinez; Stefano Michelagnoli; Giancarlo Palasciano; Vincenzo Palazzo; Domenico Palombo; Raffaele Pulli; Sonia Ronchey; Giovanni Rossi; Antonino Scolaro; Gianantonio Simoni; Francesco Spinelli; Francesco Talarico; Maurizio Taurino; Marco Trogolo; Nicola Tusini; Gianfranco Veraldi; Pier Francesco Veroux; Gennaro Vigliotti; and Pietro Volpe. The correction will appear in the online version of the paper on the JMIR website on June 24, 2020, together with the publication of this correction notice. Because this was made after submission to PubMed, PubMed Central, and other full-text repositories, the corrected article has also been resubmitted to those repositories.


2020 - Impact of plaque dilation before carotid artery stent deployment [Articolo su rivista]
Lauricella, A.; Berchiolli, R.; Moratto, R.; Ferri, M.; Viazzo, A.; Silingardi, R.
abstract

Objective: Plaque stability is of utmost importance for stroke prevention in the perioperative period (within 24 hours) following carotid artery stenting (CAS). Although carotid plaque is entrapped between stent struts after stent deployment, postdilation can cause a scissoring effect on the plaque, increasing the risk of postprocedural embolic events due to plaque prolapse. Maximum carotid plaque dilation before stent deployment may reduce this risk. This study analyzed the effect of maximum dilation of the carotid plaque before stent deployment (max-pre-SD) or after stent deployment (post-SD) on macroscopic plaque debris, hemodynamic depression (HD), and immediate major adverse events. Methods: This prospective nonrandomized multicenter study analyzed patients treated for carotid artery stenosis with CAS from January 2014 to August 2016. Clinical and morphologic characteristics and operative details were analyzed with logistic regression analysis for macroscopic debris and HD. The number of microembolic signals (MESs) was assessed by transcranial Doppler and analyzed. Results: A total of 309 patients were enrolled and treated with standard CAS performed using a proximal occlusion cerebral embolic protection device; 149 received max-pre-SD and 160 were treated with post-SD. Technical success was achieved in 100% of cases. Macroscopic debris and HD were significantly different between the two groups in favor of max-pre-SD (P <.001). A significant difference in intraprocedural MESs between the groups was detected. Compared with post-SD, max-pre-SD significantly reduced mean MES counts (8.1% vs 68.1%; P <.001). Patients treated with post-SD had a significantly increased risk of MESs in the immediate postoperative period compared with patients treated with max-pre-SD (41.9% vs 1.3%; P <.001).This result was mainly due to the small number of events encountered. Patients treated with post-SD had a 12-fold increased risk of macroscopic debris collection (odds ratio [OR], 12.36; 95% confidence interval [CI], 5.68-26.87; P <.001) and an 18 times increase in HD risk (OR, 17.80; 95% CI, 5.27-60.17; P <.001) compared with patients treated with max-pre-SD. The heterogeneous, mainly echolucent plaque type significantly highly increased the risk of macroscopic debris (OR, 78.45; 95% CI, 8.70-707.09; P <.001) while acting as a protective factor against HD (OR, 0.02; 95% CI, 0.006-0.11; P <.001) along with echogenic or echolucent complex plaques with irregular surface plaque types (OR, 0.10; 95% CI, 0.031-0.336; P <.001). No significant differences between groups (max-pre-SD group and post-SD) were detected in immediate major adverse events (minor stroke, 2.0% and 2.5% [P =.461]; major stroke, 0% and 0.6% [P =.334], respectively). Conclusions: Max-pre-SD seems to be a safe and feasible technical modification to the CAS procedure. Macroscopic debris, HD, and MESs are significantly reduced compared with CAS with post-SD. Further research with larger, randomized cohorts of patients is required to establish the superiority of this technical modification.


2020 - Influence of Thoracic Endovascular Repair on Aortic Morphology in Patients Treated for Blunt Traumatic Aortic Injuries: Long Term Outcomes in a Multicentre Study [Articolo su rivista]
Gennai, S.; Leone, N.; Andreoli, F.; Munari, E.; Berchiolli, R.; Arcuri, L.; Tusini, N.; Marcheselli, L.; Silingardi, R.
abstract

Objective: The aim of this study was to evaluate aortic remodelling and associated complications in patients treated by thoracic endovascular aneurysm repair (TEVAR) for blunt traumatic aortic injuries (BTAI). Methods: This was a retrospective, observational, multicentre study. Remodelling was considered as aortic diameter variations of >2 mm and distal graft and aortic axis angle modification measured by computed tomography angiography (CTA). The predefined levels of measurement were the proximal end of the graft (D1: landing in zone [LZ] 2; D2: LZ 3); distal end (D3); and control measurement (D4) 15 mm beyond D3. Survival, procedure, graft, and/or radiation exposure related complications were registered. CTA was required within three months and at one, six, and 10 years post-operatively. Results: Between 2004 and 2017 52 patients were treated; 47 were included for remodelling analysis (five immediate deaths were excluded); median age was 47 years (range 20–80 years). Mean TEVAR oversizing was 19.6% ± 9.7% (range 5%–35%). Following a median follow up of 67.4 ± 56.1 months (range 14–153 months) survival at one, three, six, and 10 years was 90.4% (standard error [SE] 4.1%), 88.3% (SE 4.5%) 84.8% (SE 5.5%), and 84.8% (SE 5.5%), respectively. There were no procedure/graft related complications except for one late intramural haematoma that required re-intervention. Freedom from aortic remodelling at one, six, and 10 years was 85.1% (SE 5.2%), 30.9% (SE 8.6%), and 24.7% (SE 8.8%), respectively. The increase in D1/D2 and D3 diameters were influenced by time from intervention (both p <.001), age (p <.001 and p =.002, respectively) and sealing in zone 2 (p =.027 and p =.042, respectively). For every 10% increase in oversizing, proximal neck diameter remodelling was 3.4% (p =.05). The distal axis decreased over time (p <.001; significant between three and six years). Conclusion: TEVAR is safe for BTAI in the mid to long term. This study reports a correlation between time, oversizing, and remodelling, but the level of adverse events was low.


2020 - Twenty years outcomes in a single center experience after endovascular aneurysm repair with unibody endograft and anatomical fixation [Articolo su rivista]
Silingardi, R.; Andreoli, F.; saiTTa, G. M.; Leone, N.; Migliari, M.; Gennai, S.
abstract

BaCKground: To assess the long-term safety and effectiveness of endovascular aneurysm repair (evar) treatment with unibody endograft deployed on aortic bifurcation (anatomical fixation). MeThods: a retrospective, observational, single-center study of patients treated from 1999 to 2002 with unibody bifurcated endograft. follow-up protocol required clinical and doppler-ultrasound at 1 and 6 months and annually thereafter, computed tomography angiography at 1-, 6- and 12-months and then every year. Primary endpoints included technical and treatment success, survival and freedom from late evar failure; secondary endpoints were freedom from late open conversion (loC), freedom from late re-interventions and endoleaks. resulTs: seventy-three patients, mean age of 73±6 years were enrolled. Median follow-up was 6±0.5 years. Technical success was 98.6% (n.=71/73; causes of failure: 1 open conversion and 1 type ib endoleak). a treatment success of 96% (n.=69/72) was recorded due to endoleaks (n.=2; 1 type ia and 1 type ib) and limb occlusion (n.=1). survival at 1, 5, 10, 15 and 18 years was 90%, 58%, 40%, 32% and 23% respectively. one aneurysm-related death for infection of the endograft was registered. evar failure was 14% (n.=10/71). Three loC were recorded and freedom from reinterventions at 1, 5, 10 and 18 years was 99%, 91%, 86% and 86%. fourteen endoleaks were recorded: ia (n.=6; 42.8%), ia+ib (n.=1; 7.1%), ib (n.=2; 14.2%) and ii (n.=5; 35.6%). four endoleaks were observed, 9 endovascular correction and 1 loC were required. endoleaks free survival of 90% at 1-year and 75% at the end of the study. aneurysm sac shrinkage was observed in 79% (n.=56/71). CONCLUSIONS: This small, retrospective cohort of anatomically fixed EVAR demonstrated long-term safety and effectiveness. The design of the unibody graft did not substantially change and newer generation should guarantee the same performance.


2020 - Twenty-two Year Multicentre Experience of Late Open Conversions after Endovascular Abdominal Aneurysm Repair [Articolo su rivista]
Perini, P.; Gargiulo, M.; Silingardi, R.; Bonardelli, S.; Bellosta, R.; Bonvini, S.; Michelagnoli, S.; Tusini, N.; Capelli, P.; Freyrie, A.; Mariani, E.; Faggioli, G.; Gallitto, E.; Migliari, M.; Gennai, S.; Paro, B.; Baggi, P.; Attisani, L.; Pegorer, M.; Tasselli, S.; Wassermann, V.; Chisci, E.; Troisi, N.; Fontana, A.; Strozzi, F.; Scabini, M.; Mosso, F.; Gessaroli, M.; Leone, M.; Masi, G.; Turicchia, G. U.
abstract

Objectives: The aim was to report indications, technical aspects, and outcomes of a multicentre experience of late open conversions (LOCs) after endovascular abdominal aneurysm repair (EVAR), in order to identify risk factors which may influence early morbidity and mortality rates, and long term survival. Methods: Ten vascular centres retrospectively reviewed all patients requiring LOC (≥30 days from initial EVAR, undergoing total or partial endograft explantation) from 1996 to 2017. Baseline characteristics, endograft data, indications, procedural details, post-operative outcomes, and follow up data were reviewed and analysed. Results: Included patients totalled 232 (90.1% males, mean age 74.3 ± 7.9 years). The number of LOC per year significantly increased during the study period, reaching 22 in 2017 (correlation r = 0.867, p <.0001). Reasons for LOC were 80.2% endoleak (186/232), 15.5% endograft infection (36/232), and 9.9% endograft thrombosis (23/232). Sixty-nine patients (29.7%) were operated on urgently; rupture was present in 18.5% (43/232). Eighty-nine patients (38.4%) underwent endovascular re-interventions prior to LOC. The proximal aortic cross clamp site was infrarenal in 40.5% (94/232), suprarenal in 25.4% (59/232), supracoeliac in 32.8% (76/232), and thoracic in 1.3% (3/232). Endograft explantation was total in 164/232 patients (70.7%), and partial in the remaining 68/232 (29.3%). The overall 30 day mortality was 11.2% (26/232). Early mortality was significantly higher for patients operated on urgently (26.1% vs. 4.9%, p <.001). Suprarenal clamping (odds ratio (OR) 2.34, 95% CI 1.12–4.88) and pre-existing renal insufficiency (OR 2.11, 95% CI 1.03–4.31) were independent risk factors for post-operative renal failure on multivariable analysis. Median follow up was 24.1 months (IQR 4.4–60.6). The estimated overall one and five year survival rates were 79.7% and 58.6%, respectively. Survival estimates were significantly lower for patients with endograft infection (83.8% vs. 59% at one year, 65.2% vs. 28.9% at five years; log rank p =.005), as well as for urgent patients (87.2% vs. 62.1% at one year, 65.1% vs. 43.7% at five years; log rank p <.0001). Conclusions: The annual number of LOC increased over time. LOCs performed urgently or for endograft infection are associated with poor survival. Infrarenal aortic clamping has lower post-operative complication rates.


2020 - Unibody endograft using AFX 2 for less invasive and faster endovascular aortic repair: Protocol for a multicenter nonrandomized study [Articolo su rivista]
Silingardi, R.; Sirignano, P.; Andreoli, F.; Mansour, W.; Migliari, M.; Speziale, F.
abstract

Background: Since the introduction of endovascular aortic repair (EVAR) for treatment of abdominal aortic aneurysms (AAAs), progressive improvements in results have been achieved. However, conventional bifurcated stent grafts have been proven to have a nonnegligible risk of failure and secondary intervention, principally due to the lack of adequate proximal sealing. The unique AFX 2 Endovascular AAA System (Endologix, Irvine, CA) unibody device, which provides different sealing and fixation features compared with conventional devices, seems to overcome these limitations. Objective: The aim of this study is to evaluate intraoperative, perioperative, and postoperative results in patients treated with the AFX 2 Endovascular AAA System endografts for elective AAA repair in a large cohort of consecutive patients. Methods: All eligible EVAR patients will be included in this observational, multicenter, prospective, nonrandomized study. The number of patients to be enrolled is 500. Results: The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with unibody endografts in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will also be addressed: operative time, intraoperative radiation exposure, contrast medium usage, AAA sac shrinkage at 12-month and 5-year follow-up, and any potential role of patients’ baseline characteristics and device configuration on primary endpoint. The actual start date of the investigation was November 2019. The final patient is expected to be treated by the end of December 2020, and the estimated study completion date is December 2025. Conclusions: This study will provide verified real-world data on AAAs treated by AFX 2 endografts and followed for a long-term interval.


2019 - Autologous micro-fragmented adipose tissue for the treatment of diabetic foot minor amputations: A randomized controlled single-center clinical trial (MiFrAADiF) [Articolo su rivista]
Lonardi, R.; Leone, N.; Gennai, S.; Trevisi Borsari, G.; Covic, T.; Silingardi, R.
abstract

Background: The diabetic foot ulcer (DFU) is one of the most prevalent complications of diabetes mellitus and often develops severe effects that can lead to amputation. A non-healing "minor" amputation often precedes a major amputation resulting in a negative impact on the function and quality of life of the patients. Stem cell-based therapies have emerged as a promising option to improve healing, and the adipose tissue is an abundant and easy to access source. The injection of autologous micro-fragmented adipose tissue at the amputation stump of a diabetic population undergoing a lower limb minor amputation was evaluated and compared with the standard care. Methods: In this randomized controlled trial with two arms (parallel assignment) and no masking, 114 patients undergoing a lower limb minor amputation were randomized to standard of care or to micro-fragmented adipose tissue injection prepared using a minimal manipulation technique (Lipogems®) in a closed system. Clinical outcomes were determined monthly up to 6 months. Primary endpoint of the study was the evaluation of the healing rate and time after the minor amputation. Secondary endpoints included the assessment of safety, feasibility, technical success, relapse rate, skin tropism, and intensity of pain. Results: At 6 months, 80% of the micro-fragmented adipose tissue-treated feet healed and 20% failed as compared with the control group where 46% healed and 54% failed (p = 0.0064). No treatment-related adverse events nor relapses were documented, and technical success was achieved in all cases. The skin tropism was improved in the treatment group, and the pain scale did not differ between the two groups. Conclusion: The results of this randomized controlled trial suggest that the local injection of autologous micro-fragmented adipose tissue is a safe and valid therapeutic option able to improve healing rate following minor amputations of irreversible DFU. The technique overcomes several stem cell therapy-related criticisms and its potential in wound care should be better evaluated and the therapeutic indications could be expanded. Trial registration: ClinicalTrials.gov number: NCT03276312. Date of registration: September 8, 2017 (retrospectively registered).


2019 - Comparison of aortoiliac repair with iliac branch endoprosthesis versus hypogastric occlusion in aortoiliac aneurysms [Articolo su rivista]
Verzini, F.; Cieri, E.; Parlani, G.; Pula, G.; Simonte, G.; De Blasis, G.; Di Girolamo, C.; Veroux, P.; Giaquinta, A.; Pratesi, C.; Fargion, A. T.; Silingardi, R.; Farchioni, L.; Jannello, A.; Garri-Boli, L.; Fadda, G.; Marino, M.; Cieri, E.; Simonte, G.; Parlani, G.; Speziale, F.; Mansour, W.; Giudice, R.; Sbenaglia, G.; Ippoliti, A.; Barbante, M.; Gaggiano, A.; Ferri, M.; Rispoli, P.; Verzini, F.; Varetto, G. F.; Ruffino, A.; Veraldi, G.; Mezzetto, L.
abstract

BACKGROUND: The CARIBE Study aims to assess the outcome of endovascular repair (EVAR) with iliac branch endoprosthesis (IBE) in patients with aorto-iliac aneurysms extending to iliac bifurcation, comparing these results with those of EVAR with hypogastric occlusion pres¬ ent in the recent published literature. METHODS: Patients with aorto-iliac aneurysms anatomically suitable for EVAR with IBE, are included in the study. RESULTS: Primary safety outcome measure are total and aneurysm related death free survival. Efficacy endpoints include: iliac branch patency, aneurysmal sac exclusion and freedom from reinterventions or conversion to open repair. Patient reported outcomes are evaluated with Walking Impairment Questionnaire (WIQ), International Index of Erectile Function-5 (IIEF-5) and quality of life Euro-Qual EQ-5D Questionnaire. CONCLuSIONS: Comparison with recent hystorical literature obtained in patients with EVAR with HA occlusion will offer data useful for correct information of patients affected by aorto-iliac aneurysms.


2019 - Early Experience with the Covera Stent Graft as a Bridging Stent in Branched Thoraco-Abdominal Endovascular Aneurysm Repairs [Articolo su rivista]
Gennai, S.; Antonello, M.; Leone, N.; Migliari, M.; Andreoli, F.; Dall'Antonia, A.; Grego, F.; Silingardi, R.
abstract

Purpose: To evaluate the Covera Plus (Bard, Tempe, Arizona) covered stent as a bridging stent in branched thoraco-abdominal endovascular aneurysm repair (BEVAR). Materials and Methods: Retrospective analysis of 112 self-expandable stents was performed at 2 university centers between August 2017 and March 2019. Thirty-one consecutive BEVAR procedures were studied (21 males; mean age, 75 years; 29 American Society of Anesthesiologists grade III/IV) with 119 patent target vessels (7 did not receive the studied device). Primary endpoints were technical success, branch instability, and primary/secondary clinical success. Secondary endpoints included primary/secondary patency and any adverse events. Results: Technical success was 100%. Median follow-up was 12 months (interquartile range, 6–14 months). Branch instability was registered twice (2/112), due to immediate renal occlusion and type Ic endoleak; no additional events occurred during the follow-up. Primary clinical success was 84%. There were 2 immediate deaths, 1 upper limb ischemia, 1 hemorrhage from splenic artery, and 1 type Ic endoleak; these last 3 events were successfully treated, with a secondary clinical success of 100% that was maintained during the follow-up. One late death occurred. Primary patency was 99% (111/112) and 100% (105/105) within 30 days and at the end of the study period,respectively. Adverse events included 4 acute kidney injuries and 2 spinal cord ischemia. No type I/III endoleaks, occlusion, fracture, or dislodging were diagnosed after 30 days. Conclusions: The stent graft seems safe and effective for bridging in BEVAR with low branch instability and high patency rate. Longer follow-up is required to confirm these promising results.


2019 - Endovascular aneurysm sealing with the Nellix endograft in hemodynamically-unstable ruptured abdominal aortic aneurysm with challenging anatomy [Articolo su rivista]
Gennai, S.; Saitta, G. M.; Lauricella, A.; Leone, N.; Andreoli, F.; Silingardi, R.
abstract

BACKGROUND: To assess immediate and midterm outcomes of hemodynamically-unstable patients with ruptured abdominal aortic aneurysm (rAAA) treated with the Nellix endovascular sealing system (EVAS). METHODS: From June 2014 to June 2017, 21 hemodynamically-unstable rAAA patients with challenging anatomies were treated with EVAS. The mean AAA diameter and neck length measured 73±15 mm and 14±10 mm, respectively. All the patients presented an advance trauma life support (ATLS) hemorrhage class ≥1 confirming a compromised hemodynamic status. Primary endpoints include technical success, treatment success, primary safety and 30-day survival. Secondary endpoints include re-intervention rate and time free-from-reintervention. RESULTS: Technical success was achieved in 95% (N.=20/21); one patient was converted intraoperatively to open surgery due to ongoing hemorrhage. Seven re-interventions were performed within 30-days and one during the follow-up; treatment success rate of 67% and re-intervention rate of 33%. Early endoleaks were diagnosed in 5 patients (24%). Primary safety was 52%. After a mean follow-up of 11±10 months, survival rates were 81%, 62% and 57% at 1, 6 and 12 months, respectively. Time free-from-reintervention was 15±11 months. CONCLUSIONS: Emergency-EVAS (eEVAS) appeared feasible and useful, especially in hemodynamically-unstable patients with challenging anatomies. There are some limitations in this cohort study and larger, prospective and comparative studies are required to confirm eEVAS as part of an emergency treatment protocol for rAAA.


2019 - Hybrid rescue technique after failure of a standard multibranched stent graft [Articolo su rivista]
Veraldi, G. F.; Mezzetto, L.; Scorsone, L.; Gennai, S.; Macri, M.; Silingardi, R.
abstract

A 78-year-old woman presented with type IIIC and IIID endoleaks after endovascular treatment for a thoracoabdominal aortic aneurysm. Mating between the ruptured segments of superior mesenteric artery stent graft was performed. After failed attempts at relining the right renal artery stent graft, a hybrid approach was used to connect the side branch to the target vessel: a stent graft was deployed into the side branch of the main graft and it was temporarily occluded with a balloon. After opening the sac, a stent graft was deployed into the right renal artery and the two stent grafts were connected with a running suture. Follow-up examination performed 1 month postoperatively by computed tomography imaging confirmed the effectiveness of this treatment.


2019 - Influence of Type of Fixation and Other Characteristics on Outcome after Endovascular Repair of Ruptured Abdominal Aortic Aneurysms [Articolo su rivista]
Silingardi, R.; Coppi, G.; Benassi, F.; Saitta, G.; Marcheselli, L.; Lauricella, A.; Gennai, S.
abstract

Background: Endovascular treatment nowadays represents a valuable option in the treatment of ruptured abdominal aortic aneurysms (rAAAs). The aim of this study is to evaluate a 15-year, single-center experience with endovascular treatment of rAAAs and the role of the type of fixation in outcome. Methods: Retrospective analysis of all consecutive hemodynamically stable and unstable patients with a diagnosed rAAA treated at this hospital with an endovascular procedure between December 1999 and January 2015 was conducted. Patients with symptomatic aneurysms and impending ruptures were excluded. Predictive factors of immediate and overall major complications and survival were investigated. Study end points included technical and clinical success, mortality, and major adverse events. Results: This study included 142 patients. Technical success was 97.1% within 30 days, 60 major adverse events were reported in 43 patients (30.3%), including 40 deaths (28.2%). Clinical success at 30 days was 59.9%. Predictive factors of 30-day mortality were chronic renal disease (odds ratio [OR] 3.44, P = 0.006), chronic obstructive pulmonary disease (OR 2.42, P = 0.032), hemodynamic instability at presentation (OR 4.57, P = 0.001), and the use of an aortic balloon (OR 23.4, P < 0.001). The use of local anesthesia (OR 0.38, P = 0.017) had a protective influence. One-year survival was 52%. At a median follow-up of 44 months (range 0.5–152), overall survival was 39% (95% CI 30–48), with a median overall survival of 13 month (95% CI 6–36). Five-year survival was 23%. Predictive factors of long-term mortality were advanced age (>85 years) (hazard ratio [HR] 2.0, P = 0.002), hemodynamic instability at admission (HR 1.90, P = 0.005), and the use of an aortic balloon (HR 4.56, P < 0.001). The implantation of an anatomically fixated (AFIX) device was found to be protective against mortality (OR 0.41, P = 0.011). Conclusions: In this series, satisfactory rates of complications and survival were observed after endovascular repair of rAAAs. In addition to the well-known predictors of outcome, the type of fixation also seems to play a significant role, and the AFIX device was associated with improved longer term survival when its use was deemed feasible.


2019 - Late open conversions after endovascular abdominal aneurysm repair in an urgent setting [Articolo su rivista]
Perini, P.; Gargiulo, M.; Silingardi, R.; Piccinini, E.; Capelli, P.; Fontana, A.; Migliari, M.; Masi, G.; Scabini, M.; Tusini, N.; Faggioli, G.; Freyrie, A.
abstract

Objectives: We report a multicenter experience of urgent late open conversion (LOC), with the goal of identifying the mode of presentation, technical aspects, and outcomes of this cohort of patients. Methods: A retrospective analysis of endovascular aneurysm repair (EVAR) requiring LOC (>30 days after implantation) from 1996 to 2016 in six vascular centers was performed. Patients with aneurysm rupture or other conditions requiring urgent surgery (<24 hours) were included. Patient demographics, time interval between EVAR and LOC, endograft characteristics, previous attempts at endovascular correction, indications, operative technique, 30-day mortality and morbidity, and long-term survival were analyzed. Results: There were 42 patients (88.1% men; mean age, 75.8 ± 9.0 years) included. Among the 42 explanted grafts, 33 were bifurcated, 1 tube, 6 aortouni-iliac, and 2 side-branch devices. Suprarenal fixation was present in 78.6%. Twelve patients (28.6%) underwent endovascular reintervention before LOC. Indications for urgent LOC were aneurysm rupture in 24 of the 42 cases (57.1%), endograft infection in 11 (26.2%), endoleak associated with aneurysm growth and pain in 6 (14.3%), and recurrent endograft thrombosis in 2 (4.8%). The proximal aortic cross-clamping site was infrarenal in 38.1% of cases, suprarenal in 19.1%, and supraceliac in 42.9%. Complete removal of the endograft was performed in 32 patients (76.2%) and partial removal in 10 (proximal preservation in 7 of 10). Reconstructions were performed with Dacron grafts in 33 of the 42 cases, cryopreserved arterial allografts in 5, and endograft removal associated with prosthetic axillobifemoral bypass in 4. The 30-day mortality was 23.8%; hemorrhagic shock was an independent risk factor of early mortality (odds ratio, 10.5; 95% confidence interval, 1.5-73.7; P =.018). During a mean follow-up of 23.9 ± 36.0 months, two late aneurysm-related deaths occurred. The estimated 1- and 5-year survival rates were 62.1% and 46.1%, respectively. Conclusions: Urgent LOC after EVAR are associated with high postoperative mortality rates and poor long-term survival. Further studies are necessary to define the timing and the best treatment option for failing EVAR.


2019 - New Conception of Relining in the Endovascular Aneurysm Sealing Era: A Monocentric Case Series Study [Articolo su rivista]
Saitta, G. M.; Gennai, S.; Munari, E.; Borsari, G. T.; Lauricella, A.; Migliari, M.; Silingardi, R.
abstract

Over 20 years from the first endovascular aortic repair, endoleaks still represent a common problem, even with newer endograft generation. Numerous procedures can be adopted to manage these complications; relining of the endoprosthesis is a rational technique to treat type III and IV endoleaks. The absence of dedicated materials for these procedures forces the vascular surgeon to perform complex hybrid or endovascular interventions. In this case report, we aimed to evaluate our relining experience using the Nellix device in 5 consecutive cases.


2018 - Abdominal aortic endograft: The anatomical fixation [Monografia/Trattato scientifico]
Silingardi, Roberto
abstract


2018 - Early outcomes with a single-sided access endovascular stent [Articolo su rivista]
Hofmann, M.; Pecoraro, F.; Planer, D.; Pfammatter, T.; Puippe, G.; Bettex, D.; Veith, F. J.; Lachat, M.; Chaykovska, L.; Kolvenbach, R.; Brunkwall, J.; Coppi, G.; Chiesa, R.; Silingardi, R.; Vecchiati, E.; Nessi, F.; Van Sambeek, M.; Davidovic, L.; Radak, D.
abstract

Objective: The objective of this study was to report the 1-year follow-up study results of the new Horizon stent graft (Endospan, Herzliya, Israel) from two different prospective consecutive trials. The Horizon abdominal aortic aneurysm stent graft system is a 14F profile system requiring only a single access site. It consists of three modules, introduced separately: base limb (iliac to iliac limb); distal aortic limb; and proximal aortic limb with a bare suprarenal crown and active fixation. Methods: Data from the first in man (FIM) clinical study with 10 patients enrolled and the pivotal study with 30 patients were analyzed. Outcomes measured were freedom from major adverse events (MAEs) including all-cause mortality, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, bowel ischemia, and procedural blood loss ≥1000 mL. Performance end points included successful delivery and deployment of the device, freedom from aneurysm growth ≥5 mm, type I or type III endoleak, stent graft occlusion, conversion to open surgery, rupture, and stent graft migration. Results: In the FIM study, one conversion to open surgery with >1000 mL of blood loss was registered perioperatively. In the pivotal study, no perioperative MAE was registered. Overall, at 1-year follow-up, two deaths and one aneurysm growth unrelated to endoleak were registered. Conclusions: The results of both the FIM and pivotal studies demonstrated that 39 of 40 procedures were successful for delivery and deployment of the Horizon stent graft. No MAE was registered during the follow-up. The primary safety and performance end points were met in both studies.


2018 - Nellix.The EVAS innovation. [Monografia/Trattato scientifico]
Gossetti, Bruno; Silingardi, Roberto
abstract


2018 - Preliminary results of endovascular aneurysm sealing from the multicenter Italian Research on Nellix Endoprosthesis (IRENE) study [Articolo su rivista]
Gossetti, B.; Martinelli, O.; Ferri, M.; Silingardi, R.; Verzini, F.; Angiletta, D.; Apostoulo, D.; Bellandi, G.; Berchiolli, R.; Ficarelli, R.; Frigatti, P.; Galzerano, G.; Garriboli, L.; Giudice, R.; Grossi, R.; Ippoliti, A.; Jannello, A. M.; La Barbera, G.; Lauricella, A.; Maioli, F.; Mansour, W.; Marconi, M.; Novali, C.; Parlani, G.; Pratesi, G.; Pulli, R.; Scrivere, P.; Setacci, C.; Speziale, F.; Talarico, F.; Taurino, M.; Viazzo, A.
abstract

Objective: Because of advances in technology and experience of the operator, endovascular aneurysm repair (EVAR) has supplanted open repair to treat abdominal aortic aneurysm (AAA). The low 30-day mortality and morbidity of EVAR make the endovascular approach particularly suitable for patients at high surgical risk. However, endoleak or endograft migration requiring secondary intervention or open surgical conversion is a limitation of EVAR. The Nellix system (Endologix, Inc, Irvine, Calif) has been designed to seal the entire AAA to overcome these limitations with EVAR. We report the results of a retrospective, multicenter study with endovascular aneurysm sealing (EVAS) aimed to assess technical success, procedure-related mortality, complications, and reinterventions. Methods: This study included patients selected for elective treatment with the Nellix device per the endovascular repair protocol at 16 Italian vascular centers. All patients were enrolled in a postoperative surveillance imaging program including duplex ultrasound investigations, computed tomography, and magnetic resonance controls following local standards of care. Results: From 2013 to 2015, there were 335 patients (age, 75.5 ± 7.4 years; 316 men) who underwent elective EVAS. In 295 cases (88.0%), EVAS was performed under standard instructions for use of the Nellix system. Preoperative aneurysm diameter was 55.5 ± 9.4 mm (range, 46-65 mm). The inferior mesenteric artery and lumbar arteries emerging from the AAA were patent in 61.8% and 81.3% of cases, respectively. Chimney grafts were electively carried out in eight cases (2.4%). One (0.3%) intraprocedural type IB endoleak was observed and promptly corrected. Device deployment was successful in all patients, with no perioperative mortality. Early (≤30 days) complications included 1 (0.3%) type IA endoleak, 2 (0.6%) type II endoleaks (0.6%), 2 (0.6%) stent occlusions (0.6%), 3 (0.9%) distal embolizations, and 2 (0.2%) femoral artery dissections. Six (2.9%) patients underwent reinterventions. At 1-year follow-up, complications included 3 (1.1%) type II endoleaks, 4 (1.4%) type IA endoleaks, 1 (0.3%) type IB endoleak, 2 (0.7%) distal stent migrations, 5 (1.8%) distal embolizations, and 1 (0.3%) stent occlusion. Twelve patients (3.7%) underwent reinterventions, including four (1.4%) surgical conversions due to aortoduodenal fistula (1), endograft infection (1), and type IA endoleak that was unsuccessfully treated percutaneously (2). Two AAA-related deaths occurred. Freedom from aneurysm-related reintervention was 98.3% at 1-month and 94.7% at 12-month follow-up. Conclusions: The preliminary results of this real-world multicenter study showed that EVAS with Nellix for the management of AAAs appears feasible. This device platform is associated with acceptable procedure-related mortality and low overall complication and reintervention rates. Definitive conclusions on the value of this novel device await long-term follow-up data.


2018 - Standard “off-the-shelf” multibranched thoracoabdominal endograft in urgent and elective patients with single and staged procedures in a multicenter experience [Articolo su rivista]
Silingardi, Roberto; Gennai, Stefano; Leone, Nicola; Gargiulo, Mauro; Faggioli, Gianluca; Cao, Piergiorgio; Verzini, Fabio; Ippoliti, Arnaldo; Tusini, Nicola; Ricci, Carmelo; Antonello, Michele; Chiesa, Roberto; Marone, Enrico Maria; Mangialardi, Nicola; Speziale, Francesco; Veraldi, Gian Franco; Bonardelli, Stefano; Marcheselli, Luigi; Lonardi, Roberto; Saitta, Giuseppe; Lauricella, Antonio; Ferrer, Ciro; Simonte, Gioele; Pratesi, Giovanni; Fontana, Antonio; Lucatelli, Pierleone; Dall'Antonia, Alberto; Bertoglio, Luca; Ronchey, Sonia; Mansour, Wassim; Mezzetto, Luca; Cuomo, Raffaele
abstract

Objective: The objective of this study was to assess immediate and midterm outcomes for urgent/emergent and elective patients with thoracoabdominal aortic aneurysms (TAAAs) treated with the first commercially available “off-the-shelf” multibranched endograft for endovascular aneurysm repair, with a single-step or a staged surgical approach. Methods: A multicenter, nonrandomized, retrospective study was conducted of TAAA patients grouped by urgent/emergent and elective treatment with multibranched endograft for endovascular aneurysm repair at 13 Italian centers from November 2012 to August 2016. Urgent/emergent repair was classified as rupture in 16%, impending rupture in 9%, pain in 53%, or a maximum TAAA diameter ≥80 mm in 22%. Study end points were technical success, mortality, spinal cord ischemia, target visceral vessel (TVV) patency, and procedure-related reinterventions at 30 days and at follow-up. Results: Seventy-three patients (274 TVVs) were enrolled. Treatment was performed in elective (n = 41 [56%]) or urgent/emergent (n = 32 [44%]) settings, according to a single-step (n = 30 [41%]) or staged (n = 43 [59%]) approach. Technical success was 92%. Mortality within 30 days was 4% (n = 3 urgent/emergent patients) due to myocardial infarction. Spinal cord ischemia was recorded in two patients (3%; elective group). The primary patency of TVVs was 99% (three renal branch occlusions). Procedure-related reinterventions were required in five cases (7%). At least one adverse event from any cause ≤30 days was registered in 42% (n = 31). At a median follow-up of 18 months (range, 1-43 months), eight (11%) deaths (elective vs urgent/emergent, 2% vs 22%; P =.018), three (1%) cases of branch occlusion or stenosis, and five (7%) reinterventions were recorded. A survival of 88% (standard error [SE], 4%), 86% (SE, 4%), and 82% (SE, 5%) was evidenced at 12, 24, and 36 months, respectively. Urgent/emergent repair and female gender were identified as independent risk factors for all-cause mortality (P <.001 and P =.015, respectively), and the staged approach was identified as protective (P =.026). Freedom from reintervention was 86% (SE, 4%) and 83% (SE, 5%) at 12 and 24 months. Conclusions: The first off-the-shelf multibranched endograft seems safe in both urgent/emergent and elective settings. The staged surgical approach appears to positively influence overall survival. This unique device and its operators will usher in a new treatment paradigm for TAAA repair.


2017 - Contemporary economic and clinical evaluations of endovascular repair for intact descending thoracic aortic aneurysms [Articolo su rivista]
Silingardi, R.; Gennai, S.; Coppi, G.; Chester, J.; Marcheselli, L.; Brunetti, M.
abstract

BACKGROUND: The aim of this study was to assess clinical and contemporary costs associated with elective endovascular repair of intact descending thoracic aortic aneurysms (DTAA) into the mid-Term follow-up. METHODS: A retrospective review of a prospectively maintained clinical database including 29 consecutive patients from July 2005 to December 2009 treated with elective endovascular repair (TEVAR) or TEVAR and surgical infrarenal repair (hybrid) of intact DTAA was performed. Mean age was 74.5 years old (±7.1). Primary clinical endpoints include mortality and major morbidity. Additionally a comprehensive economic appraisal of individual in-hospital and follow-up costs was executed. Economic endpoints include in-hospital and follow-up costs and patient discharge status. Elective endovascular and open repairs' clinical and economical outcomes in contemporary literature were assessed for comparison according to PRISMA standards. RESULTS: Immediate mortality was 6.9% (1/24 TEVAR and 1/5 hybrid). Three respiratory complications were recorded (11%; 2 TEVAR, 1 hybrid). Renal and cardiac complication rates were 7.4% (1 TEVAR, 1 hybrid) and 3.7% (1 TEVAR) respectively. Routine discharge home was achieved for 85% of patients (95.7% TEVAR, 25% hybrid). Three endoleaks were treated throughout the follow-up (2 TEVAR, 1 hybrid; mean 30.4 mo, ±19.9) rendering an 11% (3/27) reintervention rate. Average immediate cost was €21,976.87 for elective endovascular repair and €33,783.21 for elective endovascular hybrid repair. Additional reintervention and routine follow-up costs augmented immediate costs by 12.4%. CONCLUSIONS: This study supports satisfying immediate clinical outcomes for TEVAR and TEVAR+surgical infrarenal procedures. Although limited by a small population size and difficulties in economic comparisons, this study presents the real world social and economic cost scenario for both elective TEVAR and TEVAR hybrid treatment of DTAA of both the in-hospital and at mid term follow-up periods.


2017 - Erratum to “Choices of Stent and Cerebral Protection in the Ongoing ACST-2 Trial: A Descriptive Study” (European Journal of Vascular and Endovascular Surgery (2017) 53(5) (617–625) (S1078588417300424) (10.1016/j.ejvs.2016.12.034)) [Articolo su rivista]
de Waard, D. D.; Halliday, A.; de Borst, G. J.; Bulbulia, R.; Huibers, A.; Casana, R.; Bonati, L. H.; Tolva, V.; Fraedrich, G.; Rantner, B.; Gizewski, E.; Gruber, I.; Hendriks, J.; Cras, P.; Lauwers, P.; van Scheil, P.; Vermassen, F.; Van Herzeele, I.; Geenens, M.; Hemelsoet, D.; Lerut, P.; Lambrecht, B.; Saad, G.; Peeters, A.; Bosiers, M.; da Silva, E.; de Luccia, N.; Sitrangulo, J. C.; Estenssoro, A. E. V.; Presti, C.; Casella, I.; Monteiro, J. A. T.; Campos, W.; Puech-Leao, P.; Petrov, V.; Bachvarov, C.; Hill, M.; Mitha, A.; Wong, J.; Liu, C. -W.; Bao, L.; Yu, C.; Cvjetko, I.; Vidjak, V.; Fiedler, J.; Ostry, S.; Sterba, L.; Kostal, P.; Staffa, R.; Vlachovsky, R.; Privara, M.; Kriz, Z.; Vojtisek, B.; Krupa, P.; Reif, M.; Benes, V.; Buchvald, P.; Endrych, L.; Prochazka, V.; Kuliha, M.; Otahal, D.; Hrbac, T.; Netuka, D.; Mohapl, M.; Kramier, F.; Eldessoki, M.; Heshmat, H.; Abd-Allah, F.; Palmiste, V.; Margus, S.; Toomsoo, T.; Becquemin, J. -P.; Bergeron, P.; Abdulamit, T.; Cardon, J. -M.; Debus, S.; Thomalla, G.; Fiehler, J.; Gerloss, C.; Grzyska, U.; Storck, M.; LaMacchia, E.; Eckstein, H. H.; Sollner, H.; Berger, H.; Kallmayer, M.; Popert, H.; Zimmermann, A.; Guenther, A.; Klingner, C.; Mayer, T.; Schubert, J.; Zanow, J.; Scheinert, D.; Banning-Eichenseer, U.; Bausback, Y.; Branzan, D.; Braunilch, S.; Lenzer, J.; Schidt, A.; Staab, H.; Ulirch, M.; Barlinn, J.; Haase, K.; Abramyuk, A.; Bodechtel, U.; Gerber, J.; Reeps, C.; Pfeiffer, T.; Torello, G.; Coster, A.; Giannoukas, A.; Spanos, K.; Matsagkas, M.; Koutias, S.; Vasdekis, S.; Kakisis, J.; Moulakakis, K.; Lazaris, A.; Liapas, C.; Brountzos, E.; Lazarides, M.; Ioannou, N.; Polydorou, A.; Fulop, B.; Fako, E.; Voros, E.; Bodosi, M.; Nemeth, T.; Barzo, P.; Pazdernyik, S.; Entz, L.; Szeberin, Z.; Dosa, E.; Nemes, B.; Jaranyi, Z.; Pazdernyia, S.; Madhaban, P.; Hoffman, A.; Nikolsky, E.; Beyar, R.; Silingardi, R.; Lauricella, A.; Coppi, G.; Nicoloci, E.; Tusini, N.; Strozzi, F.; Vecchiati, E.; Ferri, M.; Ferrero, E.; Psacharopulo, D.; Gaggiano, A.; Viazzo, A.; Farchioni, L.; Parlani, G.; Caso, V.; De Rangoy, P.; Verzini, F.; Castelli, P.; DeLodovici, M. L.; Carrafiello, G.; Ierardi, A. M.; Piffaretti, G.; Nano, G.; Occhiuto, M. T.; Malacrida, G.; Tealdi, D.; Steghter, S.; Stella, A.; Pini, R.; Faggioli, G.; Sacca, S.; Negri, M. D.; Palombo, M.; Perfumo, M. C.; Fadda, G. F.; Kasemi, H.; Cernetti, C.; Tonello, D.; Visona, A.; Mangialardi, N.; Ronchey, S.; Altavista, M. C.; Michelagnoli, S.; Chisci, E.; Speziale, F.; Capoccia, L.; Veroux, P.; Giaquinta, A.; Patti, F.; Pulli, R.; Boggia, P.; Angiletta, D.; Amatucci, G.; Spinetti, F.; Mascoli, F.; Tsolaki, E.; Civilini, E.; Reimers, B.; Setacci, C.; Pogany, G.; Odero, A.; Accrocca, F.; Bajardi, G.; Takashi, I.; Masayuki, E.; Hidenori, E.; Aidashova, B.; Kospanov, N.; Bakke, S.; Skjelland, M.; Czlonkowska, A.; Kobayashi, A.; Proczka, R.; Dowzenko, A.; Czepel, W.; Polanski, J.; Bialek, P.; Ozkinis, G.; Stanisic, M.; Iwanowski, W.; Andziak, P.; Goncalves, F. B.; Starodubtsev, V.; Ignatenko, P.; Karpenko, A.; Radak, D.; Aleksic, N.; Sagic, D.; Davidovic, L.; Koncar, I.; Tomic, I.; Colic, M.; Bartkoy, D.; Rusnak, F.; Gaspirini, M.; Praczek, P.; Milosevic, Z.; Flis, V.; Bergauer, A.; Kobilica, N.; Miksic, K.; Matela, J.; Blanco, E.; Guerra, M.; Riambau, V.; Gillgren, P.; Skioldebrand, C.; Nymen, N.; Berg, B.; Delle, M.; Formgren, J.; Kally, T. B.; Qvarfordt, P.; Plate, G.; Parson, H.; Lindgren, H.; Bjorses, K.; Gottsater, A.; Warvsten, M.; Kristmundsson, T.; Forssell, C.; Malina, M.; Holst, J.; Kuhme, T.; Sonesson, B.; Lindblad, B.; Kolbel, T.; Acosta, S.; Bonati, L.; Traenka, C.; Mueller, M.; Lattman, T.; Wasner, M.; Mujagic, E.; Von Hessling, A.; Isaak, A.; Stierli, P.; Eugster, T.; Mariani, L.; Stippich, C.; Wolff, T.; Kahles, T.; Toorop, R.; Moll, F.; Lo, R.; Meershoek, A.; Jahrome, A. K.; Vos, A. W. F.; Schuiling, W.; Keunen, R.; Reijnen, M.; Macsweeney, S.; McConachie, N.; Southam, A.; Stansby, G.; Lees, T.; Lambert, D.; Clarke, M.; W
abstract

Due to a miscommunication during the production of this article, the members of the ACST-2 Collaborative Group were not properly indexed in PubMed. This has now been corrected online. We apologize for any confusion or inconvenience that this oversight might have caused.


2016 - Midterm Outcomes of the Nellix Endovascular Aneurysm Sealing System: A Dual-Center Experience [Articolo su rivista]
Silingardi, R.; Coppi, G.; Ferrero, E.; Lauricella, A.; Psacharopulo, D.; Saitta, G.; Viazzo, A.; Ferri, M.
abstract

Purpose: To report midterm outcomes of the Nellix Endovascular Aneurysm Sealing (EVAS) System in the treatment of abdominal aortic aneurysm (AAA). Methods: Between September 2013 and July 2014, 64 AAA patients (mean age 76.6±6.8 years; 61 men) were treated with the EVAS system at 2 centers (only procedures performed at least 12 months prior to the analysis were included). Most patients were treated for a stable AAA, while 1 patient was treated for a ruptured aneurysm. Mean aneurysm diameter was 57.3±9.3 mm. The proximal neck measured a mean 21.5±3.3 mm in diameter and 27.0±12.1 mm long; the neck angle was 16.9°±19.3°. Eleven (17.2%) patients were treated outside the instructions for use (IFU). Results: Technical success was achieved in 63 (98.4%) of 64 patients; 1 type Ia endoleak was treated intraoperatively. One (1.6%) aneurysm-related death occurred at 4 months due to a secondary aortoenteric fistula. Overall, endoleaks occurred in 3 (4.7%) patients (2 type Ia, 1 type II). The estimated rates for 18-month overall survival, freedom from aneurysm-related death, and freedom from secondary interventions were 92.7%, 98.4%, and 95.0%, respectively. Patients treated outside the IFU had a significantly higher incidence of device-related complications (p=0.03). Conclusion: The use of the Nellix device in everyday clinical practice is safe and offers promising midterm results. The risk of secondary aortoenteric fistula requires further analysis. Longer follow-up is needed to assess the actual efficacy of the device, although the risk of migration with late endoleak seems low.


2016 - Use of Aortic Occluders and Endovascular Plugs in a 2-step Hybrid Treatment of Secondary Aortoenteric Fistulas [Articolo su rivista]
Silingardi, R.; Coppi, G.; Saitta, G.; Lauricella, A.; Njila, M. K.; Coppi, G.
abstract

Aortoenteric fistula (AEF) is a dreadful complication of abdominal aortic surgery. Surgical treatment is associated to high mortality and requires urgent graft removal with extra-anatomic or in situ reconstruction. Other authors suggest the use of stent grafts, both as a stand-alone procedure or as a bridge solution before open repair. We reviewed the results of a cohort of patients that presented at our institution with an AEF and were treated with a novel 2-step endovascular-open surgical procedure. The first step consisted in immediate endovascular occlusion of the infrarenal graft with deployment, below the renal arteries, of an aortic occluder and/or endovascular plugs. After occlusion of the infrarenal graft, extra-anatomic reconstruction (axillofemoral bypass) was performed. The second step consisted in the removal of the infrarenal graft with aortic stump ligation and took place after a few days recovery to allow improvement of patients' condition. A total of 5 selected patients were treated. Endovascular aortic occlusion was achieved in all cases with the deployment of 1 (3 patients) or 2 (2 patients) devices. The mean interval between the first and the second step was 7 days (min 4-max 13). Complete removal of the aortic graft was possible in all patients. One patient died on the first postoperative day due to multiorgan failure (1 of 5, 20%). Mean survival after discharge was 24 months (min 6-max 36). One patient died at 6 months because of aortic stump blowout. In our initial experience, endovascular aortic occlusion seems an effective option to prevent fatal enteric bleeding and a valuable first-step treatment for selected cases of AEF.


2015 - Durability and efficacy of tibial arterial stent placement for critical limb ischemia [Articolo su rivista]
Silingardi, R.; Lauricella, A.; Copi, G.; Chester, J.; Trevisi-Borsari, G.; Corvi, V.; Marcheselli, L.; Coppi, G.
abstract

Purpose To analyze the efficacy and durability of long-term tibioperoneal arterial stent placement for selected cases of symptomatic chronic limb ischemia (CLI). Materials and Methods From January 2005 to June 2012, 168 limbs (155 patients) were treated with percutaneous transluminal angioplasty (PTA)/stent placement for de novo tibial stenosis or occlusion in at least one tibial artery. Most patients (92.9%) were classified with severe disease (Rutherford category 5/6). Concomitant interventions were performed in 58%. Bare metal (84%) and drug-eluting (16%) stents were used. Indications for stent placement were residual stenosis after PTA (> 30%), elastic recoiling, and dissection. Primary endpoints were freedom from symptomatic intrastent restenosis, target lesion revascularization (TLR), major amputation, and overall survival (OS). Results Technical success rate was 99%. Within 30 days, five deaths (3.2%) occurred, and a 1.8% (95% confidence interval [CI], 0.1%-27.2%) major adverse cardiac event rate, 3.6% (95% CI, 0.1%-22.1%) major adverse limb event rate, and 1.8% (95% CI, 0%-27.5%) amputation rate were recorded. Mean follow-up was 33 months (range, 1-96 mo). Symptomatic intrastent restenosis occurred in 20 limbs (12%) at a mean of 10.3 months ± 11.27; this was identified as a prognostic factor for limb loss (P =.045). TLR was necessary in 10.8% of limbs, for a limb salvage rate of 89.2%. OS was influenced by age (> 75 y; P <.001), diabetes (P =.048), and renal insufficiency and/or dialysis (P <.001). Estimated survival rate was 63% at 36 months (hazard ratio, 1.63; 95% CI, 54%-70%). Conclusions Stent placement offers promising short- to long-term restenosis and patency rates, even in cases of multilevel symptomatic disease. Rigorous follow-up is vital.


2015 - Midterm results of endovascular treatment of superficial femoral artery disease with biodegradable stents: Single-center experience [Articolo su rivista]
Silingardi, R.; Lauricella, A.; Coppi, G.; Nicolosi, E.; Gennai, S.; Coppi, G.
abstract

Purpose: To assess the midterm efficacy of a biodegradable poly-L-lactic acid (PLLA) stent in the treatment of superficial femoral artery (SFA) occlusive disease. Materials and Methods: Between June 2009 and April 2011, 35 de novo SFA lesions were treated with 43 biodegradable stents. This nonrandomized, retrospective, single-center study included patients with moderate or severe claudication, lower-limb rest pain, or ischemic ulceration restricted to the toes; symptoms were classified as Rutherford category 2 (48.6%), 3 (37.1%), 4 (8.6%), or 5 (5.7%). The population included 28 men and had a mean age of 71 years (range, 51-81 y). Follow-up included clinical examination and color-flow duplex imaging. Mean follow-up was 38.3 months (range, 30-58 mo). Results: Technical success was reported in all patients (100%). There were no intraoperative or immediate (< 30 d) complications.. During follow-up, one in-stent occlusion and seven in-stent restenoses occurred, all of which were successfully treated with percutaneous transluminal angioplasty. Primary and secondary patency rates were 77.1% and 97.1% at 24 and 36 months, respectively. No stent recoil or stent fracture was encountered. Late follow-up (> 12 mo) by ultrasound confirmed total reabsorption of the stent structures. Clinical improvement (ie, an upward shift of at least two Rutherford categories) was achieved in all 35 patients. Conclusions: Midterm results for biodegradable PLLA stents for atherosclerotic SFA lesions were associated with high technical success and secondary patency rates, without stent recoil and vessel remodeling.


2015 - Treatment of a ruptured abdominal aortic aneurysm with an adverse anatomy using the Nellix endovascular aneurysm sealing system [Articolo su rivista]
Coppi, G.; Saitta, G.; Lauricella, A.; Silingardi, R.
abstract


2015 - Unibody endografts for abdominal aortic aneurysm repair reduce radiation and nephrotoxic exposure compared with modular endografts [Articolo su rivista]
Silingardi, R.; Azzoni, I.; Giuliani, E.; Saitta, G.; Gennai, S.; Coppi, G.
abstract

Background To compare nephrotoxic and radiation exposure during elective endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms in a selected patient cohort treated with 2 different infrarenal endograft types: the unibody and modular. Methods Procedural data were retrospectively collected in a single center, case-controlled study. From January 2010 to January 2012, patients treated with elective EVAR were analyzed. Patients treated for thoracoabdominal aneurysms, aortic dissection, aortoiliac aneurysms, and pseudoaneurysms were excluded. The remaining subjects were divided according to the endograft type: group A treated with a unibody endograft type (60 patients) and group B (57 patients) treated with a modular endograft type. Outcome measures included total procedural time, total fluoroscopy time, and volume of contrast medium. Results All end points for group A and B were statistically significantly different; median surgical procedure duration was 75 vs. 105 min (P < 0.0001), median volume of iodine contrast injected was 85 vs. 170 mL (P < 0.0001), and median fluoroscopy time was 350 vs. 780 sec (P < 0.0001). Conclusions The overall EVAR procedural duration, fluoroscopy time, and volume of contrast medium infusion were significantly reduced in the group treated with the unibody endografts. These results seem to suggest that the unibody endograft may reduce patient risk of nephrotoxic action of the contrast medium, especially important in patients with existing renal insufficiency, and may reduce ionizing radiation exposure for both the patients and operators.


2014 - Cryopreserved autologous saphenous vein for staged treatment of bilateral popliteal aneurysms: Report of three cases [Articolo su rivista]
Coppi, G.; Ragazzi, G.; Coppi, G.; Cataldi, V.; Corvi, V.; Silingardi, R.
abstract

Popliteal artery aneurysms are the most common aneurysmal disease of the lower extremity. Although endovascular solutions are gaining consensus, open surgery with interposition grafting remains the standard of care. The great saphenous vein (GSV) is the most commonly used conduit and shows the best long-term results. However, optimal vein segments can sometimes be unavailable, thus leading to the use of unsuitable segments or prosthetic grafts. We report the cases of 3 patients who had bilateral popliteal aneurysms and only 1 GSV that was considered suitable for grafting, without alternative venous segments. All patients underwent staged treatment with the use of the GSV. After the first operation, the remaining GSV was cryopreserved and then reused for the contralateral limb. All patients had an uneventful outcome. No graft occlusions and no aneurysmal dilatations were detected at follow-up. Cryopreservation of autologous vein for staged treatment of bilateral popliteal aneurysms is feasible and seems to avoid the risk of residual GSV loss during the time inbetween the interventions. © 2014 Elsevier Inc. All rights reserved.


2014 - INCRAFT Stent-Graft System: One-year outcome of the INNOVATION trial [Articolo su rivista]
Coppi, G.; Njila, M.; Coppi, G.; Saitta, G.; Silingardi, R.; Pratesi, C.; Chiesa, R.; Scheinert, D.; Brunkwall, J. S.; Torsello, G.
abstract

Aim: Endovascular repair has surpassed open surgical treatment as the most common procedure in patients with abdominal aortic aneurysms (AAA), yet its applicability remains limited to those with aortoiliac anatomy suitable for the introduction and deployment of the devices. The current study was performed to assess the safety and efficacy of INCRAFT® (Cordis Corporation, Bridgewater, NJ), an ultra-low-profile device for the treatment of AAA. Methods: The INNOVATION study is a first in human prospective, multicenter trial involving 6 centers in Europe. From March 2010 to June 2011 60 patients with asymptomatic AAA were treated with the INCRAFT® bifurcated Stent-Graft System. The main inclusion criteria were a proximal aortic neck of 15 mm or more in length and up to 27 mm in diameter; iliac landing zones greater than 10 mm in length and between 9 and 18 mm in diameter; an access vessel large enough to accept the 14F outer diameter of the delivery system; and an aortic bifurcation >18 mm in diameter. The primary endpoint was technical success at one-month; one-year safety endpoints included the absence of device-or procedure-related major adverse events; absence of type I or III endoleaks; and maintenance of device integrity through one year of follow-up. Results: Among 60 patients treated at six centers, the primary endpoint was met in 56 of 58 patients (97%; 95% CI, 88-100%) who came back for one month follow-up, two patients did not come back for their one month follow-up assessments but remained enrolled in the study. Fifty-six had one-year follow-up data showing 100% freedom from aneurysm enlargement with absence of type I and III endoleaks in all patients. There were two patients (3.6%) with a type la endoleak which was successfully treated with secondary endovascular intervention in both occasions. Core laboratory evaluation of the postoperative imaging studies documented absence of endograft migration, stent fracture, or limb occlusion. A single patient (1.8%) died within one year due to sepsis unrelated to the AAA. Conclusion: The results of the INNOVATION study with the INCRAFT® Stent-Graft are encouraging, with satisfactory clinical outcome and device durability through one-year of follow-up. The INCRAFT® device is a novel ultra-low-profile endograft that holds promise to broaden the patient population eligible for endovascular aneurysm repair.


2014 - Mechanical thrombectomy in proximal subclavian artery in-stent occlusion [Articolo su rivista]
Silingardi, R.; Lauricella, A.; Cataldi, V.; Njila, M. K. S.; Coppi, G.
abstract

Purpose: Mechanical thrombectomy is an established tool for endovascular therapy of acute/chronic in-stent occlusions of the lower extremities, especially for the superficial femoral artery. The authors report the use of the Rotarex catheter system for an in-stent proximal subclavian occlusion. Case presentation: A 51-year-old female patient with previous multiple attempts at left subclavian revascularization; primary endovascular stenting at the origin of the subclavian artery occluded at 3 months, and a carotid-subclavian bypass was placed distally to the stent. After 6 months from the first treatment, the patient was readmitted with an acute left arm ischemia and full occlusion of the bypass was confirmed at computed tomography angiography. An anterograde thrombectomy for in-stent restenosis, together with PTA with a drug-eluting balloon was performed in the subclavian artery with confirmed patency at 6 months. Conclusion: Mechanical thrombectomy together with drug-eluting balloon PTA for in-stent occlusion or restenosis of the subclavian artery could be a promising procedure with a lower invasivity and risk with respect to surgical options. © 2013 Japanese Association of Cardiovascular Intervention and Therapeutics.


2014 - Transealing: A novel and simple technique for embolization of type 2 endoleaks through direct sac access from the distal stent-graft landing zone [Articolo su rivista]
Coppi, G.; Saitta, G.; Coppi, G.; Gennai, S.; Lauricella, A.; Silingardi, R.
abstract

Objective: Type 2 endoleak (T2EL) is the Achilles' heel of endovascular abdominal aortic aneurysm repair. Experience with transealing, an alternative technique for the treatment of T2ELs, is described. Methods: The outcome of a group of patients treated with transealing has been reviewed. Femoral access was obtained with a 9-Fr sheath. A super-stiff guide wire and a stiff hydrophilic wire were placed inside the stent-graft and a Piton GC catheter inserted. The stiff hydrophilic wire was retrieved to allow the catheter to regain its curvature and the catheter tip was placed against the iliac wall, at the edge of the stent-graft. The hydrophilic wire was then forced between the stent-graft and arterial wall into the sac. A 5/6-Fr introducer was inserted inside the sac and angiography was performed to evaluate the leak. Coils, cyanoacrylate, or fibrin glue were deployed. After removal of the catheters, the iliac limb was ballooned. Results: Seventeen patients were treated between February 2009 and April 2013. It was possible to access the aneurysm in 16/17 attempts. One patient treated with acrylic glue suffered from colon ischemia. One intraoperative secondary type 1b endoleak was treated with an iliac extension. Mean follow-up was 21.5 months. Three months of follow-up were completed in 14 patients with a 53% freedom from endoleak rate. At 1 year, the rate was 45%. During the study period, there was one surgical conversion, one aneurysm growth, and one re-embolization procedure. The remaining leaks remained stable. Conclusions: This study shows that transealing is feasible and represents a valid alternative in selected patients. The advantages of this technique are mainly its low invasiveness, reduced costs, and ease of use. © 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.


2013 - Bifurcated coronary stents for infrapopliteal angioplasty in critical limb ischemia [Articolo su rivista]
Silingardi, R; Tasselli, S; Cataldi, V; Moratto, R; Gennai, S; Coppi, Gioachino; Marcheselli, L; Coppi, G.
abstract

The goal of this article is to report the preliminary results of infrapopliteal percutaneous transluminal angioplasty stenting with the Nile Croco coronary bifurcated stent (Minvasys, Gennevilliers, France) for selected patients with critical limb ischemia (CLI).


2013 - BRAVISSIMO: 12-month results from a large scale prospective trial [Articolo su rivista]
Bosiers, M; Deloose, K; Callaert, J; Maene, L; Beelen, R; Keirse, K; Verbist, J; Peeters, P; Schroë, H; Lauwers, G; Lansink, W; Vanslembroeck, K; D'Archambeau, O; Hendriks, J; Lauwers, P; Vermassen, F; Randon, C; Van Herzeele, I; De Ryck, F; De Letter, J; Lanckneus, M; Van Betsbrugge, M; Thomas, B; Deleersnijder, R; Vandekerkhof, J; Baeyens, I; Berghmans, T; Buttiens, J; Van Den Brande, P; Debing, E; Rabbia, C; Ruffino, A; Tealdi, D; Nano, G; Stegher, S; Gasparini, D; Piccoli, G; Coppi, Gioachino; Silingardi, R; Cataldi, V; Paroni, G; Palazzo, V; Stella, A; Gargiulo, M; Muccini, N; Nessi, F; Ferrero, E; Pratesi, C; Fargion, A; Chiesa, R; Marone, E; Bertoglio, L; Cremonesi, A; Dozza, L; Galzerano, G; De Donato, G; Setacci, C.
abstract

The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR) within 12 months. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery.


2013 - How to simplify the approach to the supra-aortic trunks [Articolo su rivista]
Moratto, R; Veronesi, J; Silingardi, R; Nicolosi, E; Gennai, S; Coppi, Gioachino
abstract

Carotid artery stenting (CAS) represents a valid alternative to carotid endarterectomy (CEA). Possible embolization during the approach and the cannulation of the supra-aortic arterial trunks remains an important obstacle to CAS. This risk is increased in elderly patients and complex anatomies. In order to achieve satisfactory technical and clinical outcomes, a thorough understanding of the patients' individual anatomy of the arch and the access vessels is essential. The cannulation of the common carotid artery represents the key maneuver for the entire CAS procedure. This review article will present the currents techniques and devices actually use in order to facilitate the approach to the supra-aortic vessels.


2012 - Endovascular preservation of pelvic circulation with external iliac-to-internal iliac artery "cross-stenting" in patients with aorto-iliac aneurysms: a case report and literature review [Articolo su rivista]
Silingardi, R; Tasselli, S; Gennai, S; Saitta, G; Coppi, Gioachino
abstract

Endovascular success depends heavily upon anatomical suitability for secure graft placement. Common iliac artery (CIA) aneurysms frequently extend close to the iliac bifurcation, requiring distal fixation in the external iliac artery (EIA), in turn excluding the internal iliac artery (IIA). The preservation of circulation to at least one IIA artery is highly recommended. We report an endovascular technique for complete preservation of the hypogastric arteries of an aorto-iliac aneurysm extending into the iliac bifurcation and hypogastric artery. A left CIA aneurysm involving the iliac bifurcation was excluded with a covered Fluency stent-graft (Bard Inc., New Jersey, USA) deployed from the EIA into the IIA followed by the internal deployment of a Luminex uncovered stent (Bard Inc.) extended into one branch of the hypograstric artery. IVUS evaluation was essential in determining precise aneurysm and sealing zone measurements. Complete preservation of hypogastric circulation was achieved. The placement of the uncovered stent effectively extended the sealing zones without covering either of the hypogastric distal branches and concurrently corrected the Fluency stent kinking due to severe arterial tortuosity. In CIA aneurysms involving the IIA, an uncovered stent can extend the sealing zones, whilst maintaining complete preservation of pelvic circulation and offers support to the covered stent-graft. IVUS seems necessary for precise neck evaluation.


2012 - Endovascular treatment of ruptured thoracic aortic aneurysms [Articolo su rivista]
COPPI, Gioachino; Gennai, S.; Silingardi, R.; Saitta, G.; Trevisi Borsari, G.; Nijla, M.; Benassi, F.
abstract

NA


2012 - Urgent carotid artery stenting with technical modifications for patients with transient ischemic attacks and minor stroke [Articolo su rivista]
Moratto, R; Veronesi, J; Silingardi, R; Sacha, Nm; Trevisi Borsari, G; COPPI, Gioachino; Coppi, G.
abstract

To evaluate the safety and efficacy of urgent carotid artery stenting (CAS) with technical modifications in patients with recent (<24 hours) initial or recurrent (≥2 episodes in 24 hours) transient ischemic attacks (TIA) or with minor stroke.


2012 - Use of combined thoracic and abdominal endografts for proximal severe neck angulation in abdominal aortic aneurysms [Articolo su rivista]
Silingardi, Roberto; Antonio, Lauricella; Sebastiano, Tasselli; Giulia Trevisi Borsari, ; Njila Mistral Klend Sasha, ; Coppi, Gioachino
abstract

To evaluate endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA) with severe neck angulation (SNA) utilizing a thoracic endograft placed proximal to a bifurcated endograft.


2011 - A new idea for a safer approach to the supra-aortic trunks: the Piton™ catheter [Articolo su rivista]
Setacci, C; Moratto, R; Sirignano, P; Setacci, F; Silingardi, R; Coppi, Gioachino
abstract

Carotid artery disease is among the most common causes of stroke, and stroke is the third leading cause of death in industrialized countries. Thus the personal health and socioeconomic burden of carotid artery disease is significant. Carotid artery disease accounts for approximately 5-12% of new strokes in patients amenable to revascularization therapy. Atherosclerosis is the main reason for stroke and accounts for approximately one third of all cases. Carotid stenting is nowadays considered a valid standard alternative to surgical carotid endarterectomy, especially in patients having a high perioperative risk. The first carotid balloon angioplasty was carried out in 1979 and the first carotid balloon-expandable bare metal stents were implanted 10 years later, in 1989. However, carotid stenting at that time was associated with major complications, due to extrinsic compression and subsequent to the steel stents used. The Piton™ GC (carotid guide catheter) is intended to facilitate the introduction and placement of interventional devices (e.g., guidewires, stent delivery systems, dilation balloons, angiographic- or micro-catheters, etc.) into the human vasculature to treat vascular obstructive disease, including but not limited to the supra-aortic vessels.


2011 - Diagnostica avanzata e accessi endovascolari [Monografia/Trattato scientifico]
Silingardi, R; Coppi, G.
abstract

Volume cartonato di 576 pagine con 667 figure in nero e a colori e 74 tabelle - Questo volume intende offrire un supporto ampio e di rapida consultazione della diagnostica utile e appropriata per affrontare le procedure endoluminali secondo le più attuali conoscenze offerte dalle diverse discipline coinvolte. Per un intervenzionista che sia Chirurgo vascolare, Cardiologo o Radiologo già introdotto alle procedure oppure per chi desidera avvicinarsi a questa importante disciplina, il volume "Diagnostica avanzata e accessi endovascolari" assolve pienamente all'obiettivo di fornire una adeguata diagnostica prima e durante una procedura endoluminale o endovascolare. Il testo accosta alla diagnostica di secondo livello per le procedure endovascolari anche le informazioni necessarie per un buon approccio ai vasi con aghi, guide, cateteri ecc. proprio allo scopo di dimostrare che le procedure devono seguire a una buona diagnostica che, a sua volta, è la base di una buona clinica.


2011 - Two year follow-up results of thoracic endovascular repair with Relay Bolton endoprosthesis: the experience of the Italian participants of RESTORE I registry [Articolo su rivista]
Tealdi, D. G.; Nano G., Stegher S.; Coppi, Gioachino; Silingardi, R.; Ferro, C.; Passerone, G.
abstract

NA


2010 - A thoracic endograft for abdominal aortic aneurysms: an unusual application for severe neck angulation. A case report and literature review. [Articolo su rivista]
Silingardi, R.; Tasselli, S.; Gennai, S.; Coppi, Gioachino
abstract

Purpose: To achieve complete proximal sealing in an abdominal aortic aneurysm (AAA) with severe neck angulation (SNA) during endovascular treatment (EVAR) of a patient considered unfit for surgery.Basic methods: An 82 year-old patient with an infra-renal AAA of 9.8cm with SNA of 90° was admitted for acute coronary syndrome. Following coronary treatment, the patient was considered unfit for surgery, and therefore evaluated for EVAR. Aneurysm sac exclusion was obtained with a the deployment of a Powerlink bifurcated graft (Endologix Inc, Irvine, California) inside a Relay thoracic endograft (Bolton Medical, Florida, USA) placed just below the most distal renal artery.Principal findings: At 6 months, angio-CT confirmed correct graft placement, complete aneurysm exclusion and a reduction of the aneurysmal sac.Conclusion: In AAA patients with SNA at high risk of EVAR failure, the adaptability of a thoracic endograft could be considered for proximal sealing.


2010 - Carotid artery stent fracture identification and clinical relevance [Articolo su rivista]
Coppi, Gioachino; Moratto, R.; Veronesi, J.; Nicolosi, E.; Silingardi, R.
abstract

Background: This study was conducted to identify the prevalence, risk factors, and clinical relevance of carotid artery stentfracture.Methods: Commercially available carotid stents were implanted in this prospective, observational study that began inJanuary 2004. Indications included asymptomatic patients (stenosis >80%), symptomatic patients (stenosis >60%), andulcerated lesions (>50%). Stent integrity was assessed with plain radiography at 12 months. Data were analyzed in April2009 on a series of 341 consecutive patients treated with carotid artery stenting with at least 12 months follow-up.Results: Stent fracture prevalence was 3.4% at 12 months (95% confidence interval, 1.7%-6.1%). The median clinicalfollow-up was 30 months (range, 12-64 months) for 323 eligible patients. Treatment included 23.6% of symptomaticpatients. According to univariate analysis, calcification type III increased the odds of stent fracture by more than 4.5 times(odds ratio [OR], 4.74; P .006) and angulation >45° increased the odds of stent fracture by 6.5 times (OR, 6.51; P .008). Carotid stent cell type, stent length, and stent over-sizing were not correlated with stent fracture incidence. Stentfracture was not associated with stroke (0%), transient ischemic attack (0%), or death (0%). Restenosis was significantlyassociated with stent fracture (P < .001). Multivariate analysis evidenced that type III calcification (OR, 3.90; P .029)and angulation >45° (OR, 4.69; P .026) were important risk factors for carotid stent fracture.Conclusions: Carotid stent fracture is a rare complication after CAS and is associated with vessel angulation, calcification,and restenosis. In this series, fracture identification was independent of stroke, transient ischemic attack, and mortality.


2010 - Endovascular preservation of pelvic circulation with external Iliac - to - internal iliac artery “cross-stenting” in patients with aorto-iliac aneurysms [Articolo su rivista]
Coppi, Gioachino; Tasselli, S.; Silingardi, R.; Gennai, S.; Saitta, G.; Veronesi, J.
abstract

Abstract: Common iliac arteries (CIA) aneurysms which extend into the iliac bifurcation and internaliliac artery (IIA) usually require exclusion of the IIA, exposing pelvic ischemic complication risks. Thiscase report presents an endovascular technique of cross-stenting in a short proximal landing zone withcomplete exclusion of the CIA aneurysm using a covered stent-graft with a longer uncovered stentextending into one branch of the IIAs, maintainig full pelvic circulation. EIA to IIA cross stenting withan additional uncovered stent warrants further investigation as it seems to extend graft stentingindications, increase stability and avoid IIA exclusion.


2010 - Inflammatory abdominal aortic aneurysm endovascular repair into the long-term follow-up [Articolo su rivista]
Coppi, Gioachino; Rametta, F.; Aiello, S.; Saitta, G.; Gennai, S.; Silingardi, R.
abstract

Purpose: To investigate long-term outcomes for inflammatory abdominal aortic aneurysm(IAAA) following endovascular treatment (EVAR).Material and Methods: Between May 1997 and January 2009, 9 male patients (67 yrs, 54– 75) with IAAA were treated with EVAR using commercially available endografts. Resultswere assessed with computed tomography CT at 3 and 12 months, and every subsequenttwo years. Echo-color duplex scanning at 3, 6 and 12 months after discharge and annuallythereafter was also recommended. Primary endpoints were aneurysm-related mortality,aneurysm sac development, peri-aneurysmal fibrosis thickness (PAF) and hydronephrosisevolution.Results: No aneurysm-related deaths were observed during the follow-up of 8 patients (1patient death unknown). Overall mortality rate was 44.4% (4/9) at a mean follow-up of 69.3months (12-140). Maximum aneurysmal sac diameter progressively reduced in 8 patients(89%) and remained unchanged in 1 patient (11%). The absolute mean reduction of theaneurysm size was 26%. PAF regressed in 2 patients (22%), reduced in 5 patients (56%)and remained unchanged in 2 patients (22%). The absolute median reduction of the PAFthickness was 55%. No endoleak was observed during the follow-up period.Hydronephrosis persisted in all 3 patients pre-operatively diagnosed with this pathology.Conclusions: This series suggests that EVAR for IAAA into the long-term is associatedwith a positive trend in both PAF and aneurysm diameter reduction. No association withaneurysm-related mortality was reported. This treatment does not seem to offeradvantages for hydronephrosis.


2010 - Mechanical thrombectomy in in-stent restenosis: Preliminary experience at the iliac and femoropopliteal arteries with the Rotarex System [Articolo su rivista]
Silingardi, R.; Cataldi, V.; Moratto, R.; Azzoni, I.; Veronesi, J.; Coppi, Gioachino
abstract

Aim. Iliac and femoropopliteal arterial stenting remainscontroversial due to frequent restenosis. This study aimsto evaluate the efficacy of a mechanical rotationalthrombectomy procedure with the Rotarex MechanicalThrombectomy System (Straub Medical, Wangs, CH) andpercutaneous transluminal angioplasty (PTA) in termsof technical success, patency rates and limb salvage.Methods. From May 2006 to March 2010, 32 selectedpatients with sub-acute or chronic in-stent restenosisat the iliac or femoropopliteal arteries were treated witha Rotarex and then PTA procedure.Results. Technical success was 100%. Intra-proceduralcomplications included a superficial femoral artery(SFA) dissection (1), SFA (1) and external iliac (1) perforationsand a groin hematoma (1). There was no incidenceof embolization in this series. One patient required reintervention(3.1%); an attempted surgical bypass andamputation. Secondary reinterventions were required in17 patients (53.1%). Limb salvage rate at 12 months was90.6%. Primary patency at 30 days was 96.8%. Primary,primary assisted and secondary patency rates at 6months were 75%, 75% and 89.6% and at 12 monthswere 58.1%, 58.1% and 75.5%, respectively. Late mortalitywas 18.75% at an average follow-up of 13.1 months(3-45).Conclusion. This treatment seems promising in terms oftechnical success and embolization risk. Reinterventionsare frequently required but mid-term limb salvage ratesare encouraging. Larger, randomised studies are neededto determine the cost/benefit advantage and longtermresults.


2009 - Advancements in the Mo.Ma system procedure during cartid stenting [Articolo su rivista]
Coppi, Gioachino; Moratto, R.; Veronesi, J.; Nicolosi, E.; Chester, J.; Silingardi, R.
abstract

Aim: To reduce the incidence of clamping intolerance, asystolia, immediate mortality and neurological complications associated with carotid artery stenting (CAS) using the Mo.Masystem (Invatec, Roncadelle Brescia, Italy) embolic protection device (EPD).Methods: CAS was perfomed using the Mo.Ma system in 312 patients between January 2002 – October 2009. From October 2008 variations to the standard technique were introduced. A total of 214 patients were treated with the standard technique, and 88 with the new technique. Improvements include the engagement of the guidewire's floppy tip through the lesion whilst the cerebral blood flow is maintained, a slow release post-dilation(1 atm/2 sec), a quicker manual aspiration procedure following post dilation, a redirection of blood flow into the external carotid artery (ECA) with the post-dilation balloon inflated in the internal carotid artery (ICA), and a further manual aspiration and the subsequent release of the Mo.Ma system.Results: This study reports reduced incidence of clamping intolerance (7.9% vs 4.5%), asystolia (0 vs 1.9%), immediate mortality (0 vs 0.9%) and neurological complications (1.1% vs 3.7%). The only neurological complication associated with the new technique was a transient ischemic attack (TIA).Conclusion The new variations of the standard Mo.Ma technique seem rational in the improvement of the safety and efficacy of CAS using an EPD, in reducing the incidence of clamping intolerance and asystolia, immediate mortality and neurological complications. This series indicates a positive trend for this revised technique, but a multi-centre registry is required to validate these promising results.


2009 - Analgesia during abdominal aortic aneurysm endovascular repair: remifentanil vs fentanyl-midazolam - a randomized controlled trial [Articolo su rivista]
Giuliani, Enrico; D'Amico, Roberto; Barbieri, Alberto; Bonfreschi, V.; Malagnino, F. C.; Navi, A.; Coppi, Gioachino; Silingardi, R.
abstract

BACKGROUND AND OBJECTIVE: Endovascular repair offers a less surgically invasive procedure for abdominal aortic aneurysms but nevertheless, still requires analgesic sedative cover to ensure an acceptable level of patient comfort and cardiorespiratory stability. The peculiarity of this kind of operation is that painful stimuli are concentrated in specific moments separated by intervals devoid of pain, so the insurgence of pain can be predicted and prevented with a bolus of analgesic, making a continuous infusion not essential, but potentially useful in achieving a better analgesic stability. The primary objective of the study was pain control measured by Visual Analogue Scale; secondary endpoints were cardiorespiratory stability and an acceptable level of sedation. METHODS: The sedative analgesic protocols of two groups of randomly allocated patients, undergoing abdominal aortic aneurysm endovascular repair, were compared. The experimental group received remifentanil infusion (0.03-0.1 microg kg min) and the control group received intravenous doses of fentanyl and midazolam (1-3 microg kg and 0.05-0.1 mg kg, respectively). RESULTS: Fifty patients were investigated out of 60 enrolled. There were no relevant differences concerning cardiorespiratory stability and level of sedation, but pain levels were significantly lower in the experimental group: mean Visual Analogue Scale 0.35+/-0.40 vs. 1.49+/-0.62 (P&lt;0.001) and area under the curve 17.48+/-5.09 vs. 33.05+/-8.19 (P&lt;0.001). CONCLUSION: Both techniques were shown to be safe and most importantly effective in offering cardiovascular stability and analgesia for American Society of Anaesthesiologists III-IV patients undergoing endovascular abdominal aortic aneurysm repair. However, remifentanil continuous infusion proved to offer significantly more stable pain control compared with the currently used combination fentanyl-midazolam.


2009 - Treatment of ruptured abdominal aortic aneurysm after endovascular abdominal aortic repair: A comparison with patients without prior treatment. [Articolo su rivista]
Coppi, Gioachino; S., Gennai; G., Saitta; R., Silingardi; S., Tasselli
abstract

Objective: A retrospective analysis of immediate outcomes following aneurysm rupture (rAAA) in two groups: patientspreviously treated at our center with primary endovascular repair (EVAR) and patients without previous EVAR forabdominal aortic aneurysms (AAA) in an 8-year period.Methods: Fourteen patients with a confirmed rAAA identified throughout the follow-up period following primary EVARrepair at our center (from a population of 820 AAA treated at our center in election) were retrospectively compared with155 patients without previous EVAR in the same time period, from the introduction of an intention-to-treat protocolwith EVAR for rAAA in January 1999. Primary study outcomes included 30-day mortality and severe systemiccomplications following rAAA correction with both open and EVAR treatments.Results: In the 14 patients secondary interventions were necessary throughout follow-up prior to rupture in 43% (6/14).The mean time to rupture was 50.23 months (9-113). The mean increase in maximum aneurysmal diameter at rupturewas 18.39 mm. Type of endoleaks observed at rupture: 35.7% I proximal, 35.7% III contralateral stump disconnection,14.3% I distal, 14.3% III midgraft tear: treatment at rupture included five EVAR corrections with aortouniiliacendografts, four EVAR corrections with extensions, and five surgical conversions. Thirty-day mortality between the twogroups, 28.5% (patients with prior EVAR) 38.7% (patients without prior EVAR), and severe systemic complications, 50%vs 37.6%, were not found to be statistically significant. Hemodynamic instability, 36% (patients with prior EVAR) 63%(patients without prior EVAR), was found to be an independent predictor of 30-day mortality (P < .0001), whereassevere systemic complications, 50% vs 33.5%, did not influence the same outcome (P .852).Conclusions: In terms of mortality, it would be logical to expect a protection from the endograft in patients with previousEVAR. A trend seems to confirm this assumption, but no statistical significance was found, which may be due to the smallpopulation size.


2008 - Endovascular treatment of abdominal aortic aneurysms with the Powerlink Endograft System: influence of placement on the bifurcation and use of a proximal extension on early and late outcomes. [Articolo su rivista]
Coppi, Gioachino; Silingardi, R; Tasselli, S; Gennai, S; Saitta, G; Veraldi, Gf
abstract

Objective: We evaluated the influence of placement of the bifurcated Powerlink endograft (Endologix Inc, Irvine, Calif)on the aortic bifurcation, with the addition of a proximal extension, in the endovascular treatment (EVAR) of selectedpatients with atherosclerotic abdominal aortic aneurysms (AAAs).Methods: From September 1999 to June 2007, 205 patients were treated with the bifurcated Powerlink endograft foratherosclerotic AAA at two Italian centers with shared protocols. Patients were retrospectively divided in two groupsaccording to treatment with the bifurcated graft only (n 126), or its placement on the bifurcation with the addition ofa proximal extension (n 79) at the initial procedure. Study end points included postoperative complications, secondaryprocedures, immediate and late conversion, migration, endoleak, death, and aneurysmal sac behavior.Results: Overall technical success was 98.5%. Additional procedures were performed in 18%, and postoperative complicationsoccurred in 11.2% (systemic, 8.3%; local, 2.9%). Median follow-up was 42.4 months (range, 6-94 months).Secondary procedures were recorded in 11.2%, migration in 3.9%, type I proximal endoleak in 7.8%, and late conversionsin 2.4%. Placement on the bifurcation and the addition of an extension were associated with a higher incidence ofpostoperative complications (7.1% vs 17.7%, P .020). A reduced incidence of endoleak (19% vs 8.9%, P .048),secondary procedures (14.3% vs 6.3%, P .04), and migration (6.3% vs 0%, P .024) were observed in the group witha proximal extension. Analysis of single variables reveals that migration was significantly influenced by placement of thegraft on the bifurcation (47% vs 0%, P < .001). Both placement on the bifurcation and the addition of an extensionpositively influenced the type I proximal endoleak rate (3.8% vs 35.3% P < .001) and the need for a secondary intervention(6.3% vs 35.3% P < .001) Two aneurysm ruptures and five cases of late conversion occurred in the group treated with abifurcated graft only (4%, P .52, P .159). Analysis of aneurysm sac behavior was not statistically significant:enlargement, 4.1% vs 1.3% (P .158); reduction, 34.1% vs 40.5% (P .542).Conclusion: The placement of the bifurcated Powerlink endograft on the aortic bifurcation with a proximal extension forcomplete sealing seems to improve late outcomes, particularly secondary procedures, migration, and endoleak development.Larger prospective studies with longer follow-up are necessary to confirm these promising results.


2008 - Single-center experience with the Talent LPS endograft in patients with at least 5 years of follow-up. [Articolo su rivista]
Coppi, Gioachino; Silingardi, R; Saitta, G; Gennai, S.
abstract

Purpose: To evaluate long-term results in patients undergoing elective endovascular aneurysm repair (EVAR) using the Talent LPS endograft to treat abdominal aortic aneurysm (AAA).Methods: Fifty patients (49 men; median age 72 years, range 54–89) were treated electively between 1997 and 2001 with the Talent LPS endograft chosen for various anatomical reasons, including short (<15 mm) aortic neck (32.5%), iliac ectasia (>18 mm) in at least 1 iliac artery (32%), angulated (30°–60°) aortic neck (16%), large (>28 mm) aortic neck (6%), and tapered, reversed tapered, or bulging aortic neck (14%). A quarter of patients were preoperatively classified as unfit for AAA open repair, and 58% were high risk (ASA III or IV). The primary endpoints were immediate success, aneurysm-related and non-aneurysm related mortality, secondary interventions, graft-related complications, graft migration (>5 mm), and structural failure.Results: Implantation success was achieved in 96% (48/50). Four (8%) patients died within 30 days; in follow-up, the mortality rate was 51% over a mean 47.7 +/-27.4 months (minimum of 5 years). Aneurysm-related mortality was 12% (6/50); 3 (6%) tients were converted. The overall reintervention rate was 16% (8/50). There were 9 (18%) endoleaks in 8 patients: 4 type I (2 proximal, 2 distal), 3 type II, and 2 type III. The migration rate was 4% (1 ruptured AAA, 1 endoleak). Individual cases of graft kinking and stent fracture occurred in this series.Conclusion: Despite the small population, trends in our results suggest that the Talent stent-graft performs well over the long term. Surveillance, especially with regard to migration and graft integrity, remains of great importance.


2006 - A single-center experience in open and endovascular treatment of hemodynamically unstable and stable patients with ruptured abdominal aortic aneurysms [Articolo su rivista]
Coppi, Gioachino; Silingardi, R.; Gennai, S.; Saitta, G.; Ciardullo, A. V.
abstract

Objective: To retrospectively compare a single center’s immediate and mid-term outcomes of ruptured abdominal aorticaneurysm open and endovascular repair (EVAR) for two patient groups—hemodynamically stable and unstablepatients—in the same time period.Methods: Patients presenting at our center with confirmed rupture of an abdominal aortic aneurysm between December1999 and April 2006 were considered according to an intention-to-treat model with EVAR. Patients with symptomaticor acute (but not ruptured) AAAs were not included in this study. Thirty-three patients underwent EVAR, and 91underwent open repair. Seventy-two patients (EVAR, 45%; open, 63%) were classified as hemodynamically unstable atarrival, and 52 were classified as stable (EVAR, 55%; open, 37%). Ninety-seven percent of EVAR procedures commencedunder local anesthesia, and 100% of open repairs occurred with general anesthesia. Overall successful graft deployment,30-day mortality, overall reintervention rate, and complications were the study primary end points.Results: Overall successful graft deployment for EVAR was 91%; for open repair, it was 96%. Overall 30-day mortality forEVAR was 30% (unstable, 53%; stable, 11%), and the rate was 46% for open repair (unstable, 61%; stable, 21%). TheEVAR postoperative reintervention rate (within 30 days) was 15% (unstable, 20%; stable, 11%), and for open repair it was10% (unstable, 9%; stable, 15%). We recorded a 27% severe complication rate for EVAR patients (unstable, 40%; stable,17%), and for patients treated with open repair, it was 33% (unstable, 35%; stable, 29%). Our overall EVAR eligibility ratewas 52%, and our overall EVAR treatment rate was 27%.Conclusions: Our study’s overall results for EVAR remain encouraging when compared with those of conventional repair,but large randomized trials are required to confirm the efficacy of the procedure.


2006 - Complicanze e risultati del trattamento endovascolare [Capitolo/Saggio]
Coppi, Gioachino; Moratto, R.; Silingardi, R.; Giovannoni, M.; Ragazzi, G.; Lonardi, Roberto; Rametta, F.
abstract

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2006 - Ipertensione nefro-vascolare: Complicanze e risultati del trattamento endovascolare. [Monografia/Trattato scientifico]
Coppi, Gioachino; Moratto, R.; Silingardi, R.; Giovannoni, M.; Ragazzi, G.; Lonardi, Roberto; Rametta, F.
abstract

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2005 - Comparing outcomes of carotid endarterectomy with international benchmarks: Audit from an Italian vascular surgery department [Articolo su rivista]
Coppi, G.; Moratto, R.; Ragazzi, G.; Nicolosi, E.; Silingardi, R.; Franciosi, G. B.; Ciardullo, A. V.
abstract

Background. The aim of this study was to compare the outcomes of carotid endarterectomy (CEA) in the current practice of our department of vascular surgery with international benchmarks. Methods. In-patient data from 488 CEA performed in both symptomatic 145 (29.7%) and asymptomatic 343 (70.3%) patients with a ≥ 60% stenosis at the level of the internal carotid artery. Comprehensive retrospective review of the records for all the CEAs performed during a 2-year period. The main outcome measures were death rate, and fatal and non-fatal stroke rates perioperatively, and at 30 and 180 days. Results. The fatal and non-fatal stroke rates of symptomatic patients were: 0.7% perioperatively, 0.7% at 30 days, and 0.7% at 180 days. The fatal and non-fatal stroke rates of asymptomatic patients were: 0.6% perioperatively, 0.6% at 30 days, and 0.3% at 180 days. The death rates of symptomatic patients were 0% for all time periods. The death rates of asymptomatic patients were: 0% perioperatively, 0% at 30 days, and 0.3% at 180 days. Conclusions. The present comprehensive audit shows that our surgeons achieve CEA outcomes comparable with international benchmarks. © 2005 CEPI Srl.


2005 - Effectiveness and safety of carotid endarterectomy under remifentanil. [Articolo su rivista]
Coppi, Gioachino; Moratto, R; Ragazzi, G; Nicolosi, E; Silingardi, R; BENASSI FRANCIOSI, G; Rambaldi, M; Navi, A; Ciardullo, Av
abstract

AIM: The aim of this study was to evaluate the effectiveness and safety of carotid endarterectomy (CEA) with conscious sedation under remifentanil (Remifentanil anesthesia - RA) vs conventional loco-regional anesthesia (Conventional-LRA) in the current practice of a vascular surgery unit.METHODS: We introduced the ''Remifentanil-RA'' in our practice according to a two-step protocol. In the first step we performed a pilot prospective study to assess the procedure's safety and reproducibility in our setting on 60 consecutive patients with symptomatic and/or high-grade (&gt;70%) internal carotid artery stenosis and alternately assigning them either to ''Remifentanil-RA'' or ''Conventional-LRA'' CEA. In the second step we analysed our routine operative records as to effectiveness and safety on 533 patients who consecutively underwent ''Remifentanil-RA'' CEA. We compared them with 533 age- and sex-matched historical controls who underwent ''Conventional-LRA'' CEA.RESULTS: The patients' mean age was 71.2+/-6.8 vs 71.8+/-6.1 (''Remifentanil-RA'' vs ''Conventional-LRA''). About 73% of them were male and 56% had a symptomatic carotid stenosis. Neither the pilot study nor second step comparison showed differences in outcome measures. We found only higher peri-operative nausea/ vomit (3.6% vs 0.4% ''Remifentanil-RA'' vs ''Conventional-LRA'', P&lt;0.0002) and fewer re-operations for post-operative hematomas (3% vs 5.4% respectively, P=0.048).CONCLUSIONS: We found that ''Remifentanil-RA'' CEA was safe, effective and satisfactory. Nevertheless, with the potential problems of intubation and those already found with side effects, a randomized control trial (RCT) is needed in order to prove that this method is superior to ''Conventional-LRA'' CEA.


2005 - PRIAMUS – Proximal flow blockage cerebral protection during carotid stenting: Results from a multi-centre Italian Registry. [Articolo su rivista]
Coppi, Gioachino; Moratto, R.; Silingardi, R.; Rubino, P.; Sarropago, G.; Salemme, L.; Cremonesi, A.; Castriota, F.; Manetti, R.; Sacca, S.; Reimers, B. J.
abstract

AIM: The aim of this Italian prospective registry was to evaluate the applicability and efficacy of the Mo.Ma Device (Invatec, Roncadelle, Italy) for the prevention of cerebral embolization during carotid artery stenting (CAS) in a real world population.METHODS: In 4 Italian centers, 416 patients (300 men; mean age 71.6+/-9 years) between October 2001 and March 2005 were enrolled in a prospective registry. Two-hundred and sixty-four symptomatic (63.46%) with >50% diameter stenosis and 152 (36.54%) asymptomatic patients with >70% diameter stenosis were included. The Mo.Ma Proximal Flow Blockage Embolic Protection System was used to perform protected CAS, achieving cerebral protection by endovascular clamping of the common carotid artery (CCA) and of the external carotid artery (ECA).RESULTS: Technical success, defined as the ability to establish protection with the Mo.Ma device and to deploy the stent, was achieved in 412 cases (99.03%). The mean duration of flow blockage was 4.91+/-1.1 min. Transient intolerances to flow blockage were observed in 24 patients (5.76%), but in all cases the procedure was successfully completed. No peri-procedural strokes and deaths were observed. Complications during hospitalization included 16 minor strokes (3.84%), 3 transient ischemic attacks (0.72%), 2 deaths (0.48%) and 1 major stroke (0.24%). This resulted in a cumulative rate at discharge of 4.56% all strokes and deaths, and of 0.72% major strokes and deaths. All the patients underwent thirty-day follow-up. At thirty-day follow-up, there were no deaths and no minor and major strokes, confirming the overall cumulative 4.56% incidence of all strokes and deaths rate, and of 0.72% rate of major strokes and deaths at follow up. In 245 cases (58.89%) there was macroscopic evidence of debris after filtration of the aspirated blood.CONCLUSIONS: This Italian multicenter registry confirms and further supports the efficacy and applicability of the endovascular clamping concept with proximal flow blockage in a broad patient series. Results match favorably with current available studies on carotid stenting with cerebral protection.


2005 - PRIAMUS - Proximal flow blockage cerebral protection during carotid stenting: Results from a multicenter Italian registry [Articolo su rivista]
Coppi, G.; Moratto, R.; Silingardi, R.; Rubino, P.; Sarropago, G.; Salemme, L.; Cremonesi, A.; Castriota, F.; Manetti, R.; Sacca, S.; Reimers, B.
abstract

Aim. The aim of this Italian prospective registry was to evaluate the applicability and efficacy of the Mo.Ma Device (Invatec, Roncadelle, Italy) for the prevention of cerebral embolization during carotid artery stenting (CAS) in a real world population. Methods. In 4 Italian centers, 416 patients (300 men; mean age 71.6±9 years) between October 2001 and March 2005 were enrolled in a prospective registry. Two-hundred and sixty-four symptomatic (63.46%) with &gt;50% diameter stenosis and 152 (36.54%) asymptomatic patients with &gt;70% diameter stenosis were included. The Mo.Ma Proximal Flow Blockage Embolic Protection System was used to perform protected CAS, achieving cerebral protection by endovascular clamping of the common carotid artery (CCA) and of the external carotid artery (ECA). Results. Technic al success, defined as the ability to establish protection with the Mo.Ma device and to deploy the stent, was achieved in 412 cases (99-03%). The mean duration of flow blockage was 4.91±1.1 min. Transient intolerances to flow blockage were observed in 24 patients (5.76%), but in all cases the procedure was successfully completed. No peri-procedural strokes and deaths were observed. Complications during hospitalization included 16 minor strokes (3.84%), 3 transient ischemic attacks (0.72%), 2 deaths (0.48%) and 1 major stroke (0.24%). This resulted in a cumulative rate at discharge of 4.56% all strokes and deaths, and of 0.72% major strokes and deaths. All the patients underwent thirty-day follow up. At thirty-day follow up, there were no deaths and no minor and major strokes, confirming the overall cumulative 4.56% incidence of all strokes and deaths rate, and of 0.72% rate of major strokes and deaths at follow up. In 245 cases (58.89%) there was macroscopic evidence of debris after filtration of the aspirated blood. Conclusion. This Italian multicenter registry confirms and further supports the efficacy and applicability of the endovascular the endovascular clamping concept with proximal flow blockage in abroad patient series. Results match favorably with current available studies on carotid stenting with cerebral protection.


1997 - The Italian trial of endovascular AAA exclusion using the Parodi endograft [Articolo su rivista]
Coppi, G.; Moratto, R.; Silingardi, R.; Tusini, N.; Vecchioni, R.; Scuro, A.; Stimamiglio, P.; Adami, C. A.
abstract

Purpose: To report the outcome of the prospective 11-center Italian Parodi Trial using straight and tapered endografts for the endovascular exclusion of abdominal aortic aneurysms (AAA). Methods: From April 1994 to July 1995, 27 patients were evaluated and selected for endovascular AAA exclusion. The Parodi devices were delivered through femoral arteriotomies using 18 to 22F introducers and deployed by balloon expansion of the terminal stents. Results: Of 27 cases attempted, 24 endografts (15 tube, 9 aortomonoiliac) were implanted (1 deployment and 2 access failures [11.1%] were converted). Three endoleaks (12.5%) were treated intraoperatively with covered stents, two successfully, and the third sealed within 30 days. Three (12.5%) of the 24 treated patients died in-hospital of device- (n = 2) and procedure related (n = 1) causes; the remaining 21 patients were discharged within 8 days. Of the 8 aortomonoiliac grafts in follow-up, only 1 (12.5%) failed in the mean 23-month (range 18 to 30) follow-up; however, 4 (31%) of 13 tube graft patients were converted to surgery within 18 months. Of the 16 (66.7%) surviving endografts at 2 years, 6 (38%) showed no change in the AAA diameter, while 10 (62%) had shrunk. Conclusions: The tube graft was applicable in only about 5% of cases, and accurate endograft sizing and distal fixation were problematic. The aortomonoiliac design was not appealing to surgeons but fared better in the long term. Given the advent of newer endograft models, the Italian Parodi Trial has been terminated.


1988 - Pre-operative examination of atheromatous lesions of supra-aortic vessels by Doppler and digital subtraction angiography [Articolo su rivista]
Martinelli, C.; Aimi, G.; Torricelli, P.; Silingardi, R.; Vecchiati, E.; Coppi, G.
abstract