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

Carlo Banfi, Massimo Massetti, Martine Gilard, Hélène Eltchaninoff, Patrick Donzeau-Gouge, Karine Chevreul, Jean Fajadet, Pascal Leprince, Alain Leguerrier, Michel Lievre, Alain Prat, Emmanuel Teiger, Thierry Lefevre, Didier Tchetche, Didier Carrié, Dominique Himbert, Bernard Albat, Alain Cribier, Arnaud Sudre, Didier BlanchardGilles Rioufol, Frederic Collet, Remi Houel, Pierre Dos Santos, Nicolas Meneveau, Said Ghostine, Thibaut Manigold, Philippe Guyon, Dominique Grisoli, Herve Le Breton, Stephane Delpine, Romain Didier, Xavier Favereau, Geraud Souteyrand, Patrick Ohlmann, Vincent Doisy, Gilles Grollier, Antoine Gommeaux, Jean-Philippe Claudel, Francois Bourlon, Bernard Bertrand, Marc Laskar, Bernard Iung, Martine Gilard, Marc Laskar, Hélène Eltchaninoff, Jean Fajadet, Bernard Iung, Emmanuel Teiger, Patrick Donzeau-Gouge, Pascal Leprince, Alain Leguerrier, Alain Prat, Karine Chevreul, Michel Lievre, Michel Bertrand, Jean Cassagne, Jacques Boschat, Jean Rene Lusson, Pierre Mathieu, Yves Logeais, Jean-Paul Bessou, Thierry Lefevre, Bernard Chevalier, Arnaud Farge, Philippe Garot, Thomas Hovasse, Marie Claude Morice, Mauro Romano, Patrick Donzeau Gouge, Didier Tchetche, Olivier Vahdat, Bruno Farah, Jean Fajadet, Didier Carrie, Nicolas Dumonteil, Gérard Fournial, Bertrand Marcheix, Dominique Himbert, Patrick Nataf, Alec Vahanian, Bernard Albat, Florence Leclercq, Christophe Piot, Laurent Schmutz, Pierre Aubas, A. Du Cailar, A. Dubar, N. Durrleman, F. Fargosz, Gilles Levy, Eric Maupas, François Rivalland, G. Robert, Hélène Eltchaninoff, Jean-Paul Bessou, Alain Cribier, Christophe Tron, Arnaud Sudre, Francis Juthier, Thomas Modine, Eric Van Belle, Didier Blanchard, Thierry Sallerin, Olivier Bar, Christophe Barbey, Stephan Chassaing, Didier Chatel, Olivier Le Page, Arnaud Tauran, Gilles Rioufol, Daniele Cao, Raphael Dauphin, Guy Durand De Gevigney, Gérard Finet, Olivier Jegaden, Jean-François Obadia, Pascal Leprince, Farzin Beygui, Jean-Philippe Collet, Alain Pavie, Frédéric Collet, Pecheux, Bayet, Alain Vaillant, Jacques Vicat, Olivier Wittenberg, Rémi Houel, Patrick Joly, Roger Rosario, Patrice Bergeron, Jacques Bille, Richard Gelisse, Emmanuel Teiger, Jean-Paul Couetil, Jean-Luc Dubois Rande, Delphine Hayat, Emilie Fougeres, Jean-Luc Monin, Gauthier Mouillet, Pierre Dos Santos, Florence Arsac, Emmanuel Choukroun, Marina Dijos, Jean-Philippe Guibaud, Lionel Leroux, Nicolas Elia, Nicolas Meneveau, Descotes Genon, Sidney Chocron, François Schiele, Christophe Caussin, Alexandre Azmoun, Saïd Ghostine, Rémi Nottin, Ashok Tirouvanziam, Dominique 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 Le Breton, Issal Abouliatim, Marc Bedossa, Dominique Boulmier, Jean Philippe Verhoye, Stéphane Delepine, Jean-Louis Debrux, Alain Furber, Frédéric Pinaud, Martine Gilard, Eric Bezon, Jacques Boschat, Jean-Noel Choplain, Xavier Favereau, Oliver Bical, Grégoire Dambrin, Philippe Deleuze, Arnaud Jegou, Jean-René Lusson, Kasra Azarnouch, Nicolas Durel, Andrea Innorta, Géraud Souteyrand, Vincent Doisy, Yves Lienhart, Ricardo 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 Lognone, Rémy Sabatier, Bruno Huret, Antoine Gommeaux, Philippe Hochart, Pecheux, Jean-Philippe Claudel, Damien Bouchayer, François Gabrielle, Franck Pelissier, Guillaume Tremeau, François Bourlon, Gilles Dreyfus, Armand Eker, Yakoub Habib, Nicolas Hugues, Claude Mialhe, Bernard Bertrand, Olivier Chavanon, Paolo Porcu, Gérald Vanzetto

Risultato della ricerca: Contributo in rivistaArticolo in rivista

70 Citazioni (Scopus)

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.
Lingua originaleEnglish
pagine (da-a)1637-1647
Numero di pagine11
RivistaJOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Volume68
DOI
Stato di pubblicazionePubblicato - 2016

Keywords

  • Aged, 80 and over
  • Aortic Valve Stenosis
  • Female
  • France
  • Humans
  • Male
  • Prospective Studies
  • Registries
  • Risk Assessment
  • Time Factors
  • Transcatheter Aortic Valve Replacement
  • Treatment Outcome
  • aortic stenosis
  • predictive analysis
  • risk score

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