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Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients The FRANCE-2 Registry

Martine Gilard 1 Hélène Eltchaninoff 2, 3 Patrick Donzeau-Gouge 4 Karine Chevreul 5, 6 Jean Fajadet 7 Pascal Leprince 8 Alain Leguerrier 9, 10 Michel Lievre 11 Alain Prat Emmanuel Teiger 12, 13, 14 Thierry Lefèvre Didier Tchetche Didier Carrie 15, 16, 17 Dominique Himbert 18 Bernard Albat 19 Alain Cribier 2 Arnaud Sudre 20 Didier Blanchard 21 Gilles Rioufol 22 Frederic Collet Remi Houel Pierre dos Santos 23 Nicolas Meneveau 24 Said Ghostine Thibaut Manigold Philippe Guyon Dominique Grisoli Hervé Le Breton 25 Stephane Delpine Romain Didier Xavier Favereau Geraud Souteyrand Patrick Ohlmann Vincent Doisy Gilles Grollier 26 Antoine Gommeaux Jean-Philippe Claudel Francois Bourlon Bernard Bertrand Marc Laskar 27, 28 Bernard Iung 29
11 Evaluation et modélisation des effets thérapeutiques
Département biostatistiques et modélisation pour la santé et l'environnement [LBBE]
Abstract : BACKGROUND Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up. OBJECTIVES This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. METHODS The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used. RESULTS A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade >= 2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in < 2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up. CONCLUSIONS The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time. (J Am Coll Cardiol 2016; 68: 1637-47) (C) 2016 by the American College of Cardiology Foundation.
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Submitted on : Monday, December 12, 2016 - 12:44:40 PM
Last modification on : Tuesday, July 20, 2021 - 5:20:07 PM

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Martine Gilard, Hélène Eltchaninoff, Patrick Donzeau-Gouge, Karine Chevreul, Jean Fajadet, et al.. Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients The FRANCE-2 Registry. Journal of the American College of Cardiology, Elsevier, 2016, 68 (15), pp.1637--1647. ⟨10.1016/j.jacc.2016.07.747⟩. ⟨hal-01414473⟩



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