Registry of transcatheter aortic-valve implantation in high-risk patients
Martine Gilard, Hélène Eltchaninoff, Bernard Iung, Patrick Donzeau-Gouge, Karine Chevreul, Jean Fajadet, Pascal Leprince, Alain Leguerrier, Michel Lievre, Alain Prat, Emmanuel Teiger, Thierry Lefevre, Dominique Himbert, Didier Tchetche, Didier Carrié, Bernard Albat, Alain Cribier, Gilles Rioufol, Arnaud Sudre, Didier Blanchard, Frederic Collet, Pierre Dos Santos, Nicolas Meneveau, Ashok Tirouvanziam, Christophe Caussin, Philippe Guyon, Jacques Boschat, 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, Eric Van Belle, Marc Laskar, FRANCE 2 Investigators, 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, Pierre Mathieu, Yves Logeais, 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, Dominique Himbert, Patrick Nataf, Alec Vahanian, Didier Carrie, Nicolas Dumonteil, Gérard Fournial, Bertrand Marcheix, 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, Gilles Rioufol, Daniele Cao, Raphael Dauphin, Guy Durand De Gevigney, Gérard Finet, Olivier Jegaden, Jean-François Obadia, Arnaud Sudre, Francis Juthier, Thomas Modine, Eric Van Belle, Carlo Banfi, Didier Blanchard, Thierry Sallerin, Olivier Bar, Christophe Barbey, Stephan Chassaing, Didier Chatel, Olivier Le Page, Arnaud Tauran, Pascal Leprince, Farzin Beygui, Jean-Philippe Collet, Alain Pavie, Emmanuel Teiger, Jean-Paul Couetil, Jean-Luc Dubois Rande, Delphine Hayat, Emilie Fougeres, Jean-Luc Monin, Gauthier Mouillet, Frédéric Collet, Pecheux, Bayet, Alain Vaillant, Jacques Vicat, Olivier Wittenberg, Pierre Dos Santos, Florence Arsac, Emmanuel Choukroun, Marina Dijos, Jean-Philippe Guibaud, Lionel Leroux, Nicolas Elia, Nicolas Meneveau, Descotes Genon, Sidney Chocron, François Schiele, Ashok Tirouvanziam, Dominique Crochet, Régis Gaudin, Jean-Christian Roussel, Christophe Caussin, Alexandre Azmoun, Saïd Ghostine, Rémi Nottin, Philippe Guyon, Nicolas Bonnet, Franck Digne, Patrick Mesnidrey, Thierry Royer, Victor Stratiev, Martine Gilard, Eric Bezon, Jacques Boschat, Jean-Noel Choplain, Hervé Le Breton, Issal Abouliatim, Marc Bedossa, Dominique Boulmier, Jean Philippe Verhoye, Frédéric Collart, Jean-Louis Bonnet, Thomas Cuisset, Dominique Grisoli, Rémi Houel, Patrick Joly, Roger Rosario, Patrice Bergeron, Jacques Bille, Richard Gelisse, Stéphane Delepine, Jean-Louis Debrux, Alain Furber, Frédéric Pinaud, Jean-René Lusson, Kasra Azarnouch, Nicolas Durel, Andrea Innorta, Géraud Souteyrand, Xavier Favereau, Oliver Bical, Grégoire Dambrin, Philippe Deleuze, Arnaud Jegou, Patrick Ohlmann, Michel Kindo, Jean-Philippe Mazzucotelli, Michel Zupan, Vincent Doisy, Yves Lienhart, Ricardo Roriz, Patrick Staat, Didier Blanchard, Jean-Noël Fabiani, Antoine Lafont, Rachid Zegdi, Didier Heudes, Gilles Grollier, Calin Ivascau, Thérèse Lognone, Massimo Massetti, 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, Martine Gilard, Hélène Eltchaninoff, Bernard Iung, Patrick Donzeau-Gouge, Karine Chevreul, Jean Fajadet, Pascal Leprince, Alain Leguerrier, Michel Lievre, Alain Prat, Emmanuel Teiger, Thierry Lefevre, Dominique Himbert, Didier Tchetche, Didier Carrié, Bernard Albat, Alain Cribier, Gilles Rioufol, Arnaud Sudre, Didier Blanchard, Frederic Collet, Pierre Dos Santos, Nicolas Meneveau, Ashok Tirouvanziam, Christophe Caussin, Philippe Guyon, Jacques Boschat, 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, Eric Van Belle, Marc Laskar, FRANCE 2 Investigators, 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, Pierre Mathieu, Yves Logeais, 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, Dominique Himbert, Patrick Nataf, Alec Vahanian, Didier Carrie, Nicolas Dumonteil, Gérard Fournial, Bertrand Marcheix, 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, Gilles Rioufol, Daniele Cao, Raphael Dauphin, Guy Durand De Gevigney, Gérard Finet, Olivier Jegaden, Jean-François Obadia, Arnaud Sudre, Francis Juthier, Thomas Modine, Eric Van Belle, Carlo Banfi, Didier Blanchard, Thierry Sallerin, Olivier Bar, Christophe Barbey, Stephan Chassaing, Didier Chatel, Olivier Le Page, Arnaud Tauran, Pascal Leprince, Farzin Beygui, Jean-Philippe Collet, Alain Pavie, Emmanuel Teiger, Jean-Paul Couetil, Jean-Luc Dubois Rande, Delphine Hayat, Emilie Fougeres, Jean-Luc Monin, Gauthier Mouillet, Frédéric Collet, Pecheux, Bayet, Alain Vaillant, Jacques Vicat, Olivier Wittenberg, Pierre Dos Santos, Florence Arsac, Emmanuel Choukroun, Marina Dijos, Jean-Philippe Guibaud, Lionel Leroux, Nicolas Elia, Nicolas Meneveau, Descotes Genon, Sidney Chocron, François Schiele, Ashok Tirouvanziam, Dominique Crochet, Régis Gaudin, Jean-Christian Roussel, Christophe Caussin, Alexandre Azmoun, Saïd Ghostine, Rémi Nottin, Philippe Guyon, Nicolas Bonnet, Franck Digne, Patrick Mesnidrey, Thierry Royer, Victor Stratiev, Martine Gilard, Eric Bezon, Jacques Boschat, Jean-Noel Choplain, Hervé Le Breton, Issal Abouliatim, Marc Bedossa, Dominique Boulmier, Jean Philippe Verhoye, Frédéric Collart, Jean-Louis Bonnet, Thomas Cuisset, Dominique Grisoli, Rémi Houel, Patrick Joly, Roger Rosario, Patrice Bergeron, Jacques Bille, Richard Gelisse, Stéphane Delepine, Jean-Louis Debrux, Alain Furber, Frédéric Pinaud, Jean-René Lusson, Kasra Azarnouch, Nicolas Durel, Andrea Innorta, Géraud Souteyrand, Xavier Favereau, Oliver Bical, Grégoire Dambrin, Philippe Deleuze, Arnaud Jegou, Patrick Ohlmann, Michel Kindo, Jean-Philippe Mazzucotelli, Michel Zupan, Vincent Doisy, Yves Lienhart, Ricardo Roriz, Patrick Staat, Didier Blanchard, Jean-Noël Fabiani, Antoine Lafont, Rachid Zegdi, Didier Heudes, Gilles Grollier, Calin Ivascau, Thérèse Lognone, Massimo Massetti, 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
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.).
Source: PubMed