Wieneke Vlastra1, Jaya Chandrasekhar1,2, Antonio J Muñoz-Garcia3, Didier Tchétché4, Fabio S de Brito5, Marco Barbanti6, Ran Kornowski7, Azeem Latib8, Augusto D'Onofrio9, Flavio Ribichini10, Jan Baan1, Jan G P Tijssen1, Ramiro Trillo-Nouche11, Nicolas Dumonteil4, Alexandre Abizaid12, Samantha Sartori2, Paola D'Errigo13, Giuseppe Tarantini9, Mattia Lunardi10, Katia Orvin7, Matteo Pagnesi8, Raquel Del Valle14, Thomas Modine15, George Dangas2, Roxana Mehran2, Jan J Piek1, Ronak Delewi1. 1. Department of Clinical and Experimental Cardiology, Heart Center, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands. 2. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, New York, NY, USA. 3. Department of Cardiology, Hospital Universitario Virgen de la Victoria, Campus de Teatinos, S/N, Málaga, Spain. 4. Clinique Pasteur, 45 Avenue de Lombez - BP 27617 - 31076 TOULOUSE, Toulouse, France. 5. Heart Institute (InCor), University of São Paulo Medical School, Av. Dr. Enéas Carvalho de Aguiar, 44 - Cerqueira César, São Paulo - SP, Brazil. 6. Division of Cardiology, Policlinico-Vittorio Emanuele Hospital, University of Catania, Via Salvatore Citelli, 6, Catania CT, Italy. 7. Cardiology Department, Rabin Medical Center, Ze'ev Jabotinsky St 39, Petah Tikva, Israel. 8. Interventional Cardiology Unit, San Raffaele Scientific Institute, Via Olgettina Milano, 58, Milano MI, Italy. 9. Department of Cardiac, Thoracic and Vascular Sciences, Interventional Cardiology Unit, University of Padova, Via Nicolò Giustiniani, 2, Padova PD, Italy. 10. Division of Cardiology, Department of Medicine, University of Verona, Policlinico GB Rossi, Piazzale L.A. Scuro 10, Verona, Italy. 11. Servicio de Cardiología, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Rúa da Choupana, s/n, 15706 Santiago de Compostela, A Coruña, Spain. 12. Instituto Dante Pazzanese de Cardiologia, Av. Dr. Dante Pazzanese, 500 - Vila Mariana, São Paulo - SP, Brazil. 13. National Centre for Global Helath-Istituto Superiore di Sanità, Viale Regina Elena, 299, Roma RM, Italy. 14. Hospital Universitario Central de Asturias, Julian Claveria. S/N, 33011 Oviedo, Asturias, Spain. 15. Centre Hospitalier Universitaire, 2, avenue Oscar Lambret - 59037 Lille, France.
Abstract
Aims: The aim of this study was to compare clinical outcomes of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with balloon-expandable (BE) valves vs. self-expandable (SE) valves. Transcatheter aortic valve implantation is a minimally invasive and lifesaving treatment in patients with aortic valve stenosis. Even though BE-valves and SE-valves are both commonly used on a large scale, adequately sized trials comparing clinical outcomes in patients with severe aortic valve stenosis treated with BE-valves compared with SE-valves are lacking. Methods and results: In this CENTER-collaboration, data from 10 registries or clinical trials, selected through a systematic search, were pooled and analysed. Propensity score methodology was used to reduce treatment selection bias and potential confounding. The primary endpoints were mortality and stroke at 30 days follow-up in patients treated with BE-valves compared with SE-valves. Secondary endpoints included clinical outcomes, e.g. bleeding during hospital admission. All outcomes were split for early-generation BE-valves compared with early-generation SE-valves and new-generation BE-valves with new-generation SE-valves. The overall patient population (N = 12 381) included 6239 patients undergoing TAVI with BE-valves and 6142 patients with SE-valves. The propensity matched population had a mean age of 81 ± 7 years and a median STS-PROM score or 6.5% [interquartile range (IQR) 4.0-13.0%]. At 30-day follow-up, the mortality rate was not statistically different in patients undergoing TAVI with BE-valves compared with SE-valves [BE: 5.3% vs. SE: 6.2%, relative risk (RR) 0.9; 95% confidence interval (CI) 0.7-1.0, P = 0.10]. Stroke occurred less frequently in patients treated with BE-valves (BE: 1.9% vs. SE: 2.6%, RR 0.7; 95% CI 0.5-1.0, P = 0.03). Also, patients treated with BE-valves had a three-fold lower risk of requiring pacemaker implantation (BE: 7.8% vs. SE: 20.3%, RR 0.4; 95% CI 0.3-0.4, P < 0.001). In contrast, patients treated with new-generation BE-valves more frequently experienced major and life-threatening bleedings compared with new-generation SE-valves (BE: 4.8% vs. SE: 2.1%, RR 2.3; 95% CI 1.6-3.3, P < 0.001). Conclusion: In this study, which is the largest study to compare valve types in TAVI, we demonstrated that the incidence of stroke and pacemaker implantation was lower in patients undergoing transfemoral TAVI with BE-valves compared with SE-valves. In contrast, patients treated with new-generation BE-valves more often suffered from major or life-threatening bleedings than patients with new-generation SE-valves. Mortality at 30-days was not statistically different in patients treated with BE-valves compared with SE-valves. This study was a propensity-matched analysis generated from observational data, accordingly current outcomes will have to be confirmed in a large scale randomized controlled trial.
Aims: The aim of this study was to compare clinical outcomes of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with balloon-expandable (BE) valves vs. self-expandable (SE) valves. Transcatheter aortic valve implantation is a minimally invasive and lifesaving treatment in patients with aortic valve stenosis. Even though BE-valves and SE-valves are both commonly used on a large scale, adequately sized trials comparing clinical outcomes in patients with severe aortic valve stenosis treated with BE-valves compared with SE-valves are lacking. Methods and results: In this CENTER-collaboration, data from 10 registries or clinical trials, selected through a systematic search, were pooled and analysed. Propensity score methodology was used to reduce treatment selection bias and potential confounding. The primary endpoints were mortality and stroke at 30 days follow-up in patients treated with BE-valves compared with SE-valves. Secondary endpoints included clinical outcomes, e.g. bleeding during hospital admission. All outcomes were split for early-generation BE-valves compared with early-generation SE-valves and new-generation BE-valves with new-generation SE-valves. The overall patient population (N = 12 381) included 6239 patients undergoing TAVI with BE-valves and 6142 patients with SE-valves. The propensity matched population had a mean age of 81 ± 7 years and a median STS-PROM score or 6.5% [interquartile range (IQR) 4.0-13.0%]. At 30-day follow-up, the mortality rate was not statistically different in patients undergoing TAVI with BE-valves compared with SE-valves [BE: 5.3% vs. SE: 6.2%, relative risk (RR) 0.9; 95% confidence interval (CI) 0.7-1.0, P = 0.10]. Stroke occurred less frequently in patients treated with BE-valves (BE: 1.9% vs. SE: 2.6%, RR 0.7; 95% CI 0.5-1.0, P = 0.03). Also, patients treated with BE-valves had a three-fold lower risk of requiring pacemaker implantation (BE: 7.8% vs. SE: 20.3%, RR 0.4; 95% CI 0.3-0.4, P < 0.001). In contrast, patients treated with new-generation BE-valves more frequently experienced major and life-threatening bleedings compared with new-generation SE-valves (BE: 4.8% vs. SE: 2.1%, RR 2.3; 95% CI 1.6-3.3, P < 0.001). Conclusion: In this study, which is the largest study to compare valve types in TAVI, we demonstrated that the incidence of stroke and pacemaker implantation was lower in patients undergoing transfemoral TAVI with BE-valves compared with SE-valves. In contrast, patients treated with new-generation BE-valves more often suffered from major or life-threatening bleedings than patients with new-generation SE-valves. Mortality at 30-days was not statistically different in patients treated with BE-valves compared with SE-valves. This study was a propensity-matched analysis generated from observational data, accordingly current outcomes will have to be confirmed in a large scale randomized controlled trial.
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