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Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients

2016; Elsevier BV; Volume: 68; Issue: 15 Linguagem: Inglês

10.1016/j.jacc.2016.07.747

1558-3597

Martine Gilard, Hélène Eltchaninoff, Patrick Donzeau‐Gouge, Karine Chevreul, Jean Fajadet, Pascal Leprince, Alain Leguerrier, Michel Lièvre, Alain Prat, Emmanuel Teíger, Thierry Lefevre, Didier Tchétché, Didier Carrié, Dominique Himbert, Bernard Albat, Alain Cribier, Arnaud Sudre, Didier Blanchard, Gilles Rioufol, F Collet, Rémi Houël, Pierre Dos Santos, Nicolas Méneveau, Saïd Ghostine, Thibaut Manigold, Philippe Guyon, Dominique Grisoli, Hervé Breton, Stephane Delpine, Romain Didier, Xavier Favereau, Géraud Souteyrand, Patrick Ohlmann, Vincent Doisy, Gilles Grollier, Antoine Gommeaux, Jean-Philippe Claudel, F Bourlon, Bernard Bertrand, Marc Laskar, Bernard Iung, Martine Gilard, Marc Laskar, Hélène Eltchaninoff, Jean Fajadet, Bernard Iung, Emmanuel Teíger, Patrick Donzeau‐Gouge, Pascal Leprince, Alain Leguerrier, Alain Prat, Karine Chevreul, Michel Lièvre, Michel Bertrand, J Cassagne, J Boschat, Jean Rene Lusson, Pierre Mathieu, Y Logeais, Jean-Paul Bessou, Thierry Lefevre, Bernard Chevalier, Arnaud Farge, Philippe Garot, Thomas Hovasse, Marie Claude Morice, Mauro Romano, P. Donzeau Gouge, Didier Tchétché, Olivier Vahdat, Bruno Farah, Jean Fajadet, Didier Carrié, Nicolas Dumonteil, G Fournial, Bertrand Marcheix, Dominique Himbert, Patrick Nataf, Alec Vahanian, Bernard Albat, Florence Leclercq, Christophe Piot, Laurent Schmutz, P Aubas, A. du Cailar, Arnaud Dubar, Nicolas Dürrleman, F. Fargosz, Gilles Levy, Eric Maupas, François Rivalland, Gabriel Robert, Hélène Eltchaninoff, Jean-Paul Bessou, Alain Cribier, Christophe Tron, Arnaud Sudre, Françis Juthier, Thomas Modine, Éric Van Belle, Carlo Banfı, Didier Blanchard, T Sallerin, Olivier Bar, Christophe Barbey, Stéphan Chassaing, Didier Chatel, Olivier Le Page, Arnaud Tauran, Gilles Rioufol, D. Cao, Raphaël Dauphin, Guy Durand de Gevigney, Gérard Finet, Olivier Jegaden, Jean‐François Obadia, Pascal Leprince, Farzin Beygui, Jean-Philippe Collet, Alain Pavie, F Collet, Pecheux, Bayet, A Vaillant, Jacques Vicat, Olivier Wittenberg, Rémi Houël, Patrick Joly, Roger Rosario, Patrice Bergeron, Jacques Bille, Richard Gélisse, Emmanuel Teíger, Jean-Paul Couëtil, Jean‐Luc Dubois Randé, Delphine Hayat, Emilie Fougères, Jean-Luc Monin, Gauthier Mouillet, Pierre Dos Santos, Florence Arsac, Emmanuel Choukroun, Marina Dijos, Jean-Philippe Guibaud, Lionel Leroux, Nicolas Elia, Nicolas Méneveau, Descotes Genon, Sidney Chocron, François Schiele, Christophe Caussin, Alexandre Azmoun, Saïd Ghostine, R Nottin, Ashok Tirouvanziam, D Crochet, Régis Gaudin, Jean-Christian Roussel, Philippe Guyon, Nicolas Bonnet, Franck Digne, Patrick Mesnidrey, Thierry Royer, Victor Stratiev, Dominique Grisoli, Jean‐Louis Bonnet, Thomas Cuisset, Dominique Grisoli, Hervé Breton, I. Abouliatim, Marc Bédossa, Dominique Boulmier, Jean Philippe Verhoye, Stéphane Delepine, Jean-Louis Debrux, Alain Furber, Frédéric Pinaud, Martine Gilard, Eric Bezon, J Boschat, Jean-Noël Choplain, Xavier Favereau, O Bical, Grégoire Dambrin, Philippe Deleuze, Arnaud Jégou, Jean‐René Lusson, Kasra Azarnouch, Nicolas Durel, Andréa Innorta, Géraud Souteyrand, Vincent Doisy, Yves Lienhart, R Roriz, Patrick Staat, Didier Blanchard, Jean-Noël Fabiani, Antoine Lafont, Rachid Zegdi, Didier Heudes, Patrick Ohlmann, Michel Kindo, Jean‐Philippe Mazzucotelli, Michel Zupan, Gilles Grollier, Calin Ivascau, Thérèse Lognoné, Massimo Massetti, Rémy Sabatier, Bruno Huret, Antoine Gommeaux, Philippe Hochart, Pecheux, Jean-Philippe Claudel, Damien Bouchayer, F Gabrielle, Franck Pelissier, G Trémeau, F Bourlon, Gilles Dreyfus, Armand Eker, Y Habib, Nicolas Hugues, Claude Mialhe, Bernard Bertrand, Olivier Chavanon, Paolo Porcu, Gérald Vanzetto,

Cardiac Imaging and Diagnostics

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. This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. 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. 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. 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.