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Registry of transcatheter aortic-valve implantation in high-risk patients.

Martine Gilard 1 Hélène Eltchaninoff Bernard Iung 2 Patrick Donzeau-Gouge Karine Chevreul Jean Fajadet Pascal Leprince 3 Alain Leguerrier 4 Michel Lievre 5 Alain Prat Emmanuel Teiger 6 Thierry Lefevre Dominique Himbert 2 Didier Tchetche Didier Carrié 7 Bernard Albat 8 Alain Cribier 9 Gilles Rioufol 10 Arnaud Sudre Didier Blanchard Frederic Collet Pierre dos Santos 11 Nicolas Meneveau Ashok Tirouvanziam 12 Christophe Caussin Philippe Guyon Jacques Boschat 1 Herve Le Breton Frederic Collart Remi Houel Stephane Delpine Geraud Souteyrand Xavier Favereau Patrick Ohlmann Vincent Doisy Gilles Grollier Antoine Gommeaux Jean-Philippe Claudel Francois Bourlon Bernard Bertrand 13 Eric van Belle 14 Marc Laskar 15, 16, 17 Non Renseigné
Abstract : BACKGROUND: Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2. METHODS: All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause. RESULTS: A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival. CONCLUSIONS: This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).
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Submitted on : Thursday, April 11, 2013 - 12:41:48 AM
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Martine Gilard, Hélène Eltchaninoff, Bernard Iung, Patrick Donzeau-Gouge, Karine Chevreul, et al.. Registry of transcatheter aortic-valve implantation in high-risk patients.. New England Journal of Medicine, Massachusetts Medical Society, 2012, 366 (18), pp.1705-15. ⟨10.1056/NEJMoa1114705⟩. ⟨hal-00811695⟩



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