Registry of Transcatheter Aortic-Valve Implantation in High-Risk Patients

被引:976
作者
Gilard, Martine [1 ]
Eltchaninoff, Helene [2 ]
Iung, Bernard [3 ]
Donzeau-Gouge, Patrick [6 ]
Chevreul, Karine [4 ]
Fajadet, Jean [7 ]
Leprince, Pascal [5 ]
Leguerrier, Alain [9 ]
Lievre, Michel [10 ]
Prat, Alain [13 ]
Teiger, Emmanuel [4 ]
Lefevre, Thierry [6 ]
Himbert, Dominique [3 ]
Tchetche, Didier [7 ]
Carrie, Didier [8 ]
Albat, Bernard [14 ]
Cribier, Alain [2 ]
Rioufol, Gilles [16 ]
Sudre, Arnaud [13 ]
Blanchard, Didier [15 ]
Collet, Frederic [17 ,19 ]
Dos Santos, Pierre [23 ]
Meneveau, Nicolas [21 ]
Tirouvanziam, Ashok [24 ]
Caussin, Christophe [20 ]
Guyon, Philippe [22 ]
Boschat, Jacques [1 ]
Le Breton, Herve [9 ]
Collart, Frederic
Houel, Remi [18 ]
Delpine, Stephane [25 ]
Souteyrand, Geraud [26 ]
Favereau, Xavier [27 ]
Ohlmann, Patrick [28 ]
Doisy, Vincent [11 ]
Grollier, Gilles [29 ]
Gommeaux, Antoine [30 ]
Claudel, Jean-Philippe [12 ]
Bourlon, Francois [33 ]
Bertrand, Bernard [31 ]
Van Belle, Eric [13 ]
Laskar, Marc [32 ]
机构
[1] CHU Brest, F-29285 Brest, France
[2] Univ Rouen, Hop Charles Nicolle, INSERM, U1096, Rouen, France
[3] Hop Bichat Claude Bernard, F-75877 Paris, France
[4] CHU Henri Mondor, Paris, France
[5] Hop La Pitie Salpetriere, Paris, France
[6] Inst Jacques Cartier, Massy, France
[7] Clin Pasteur, Toulouse, France
[8] CHU Toulouse, Toulouse, France
[9] CHU Rennes, Rennes, France
[10] Univ Lyon 1, F-69365 Lyon, France
[11] Clin Tonkin, Lyon, France
[12] Infirm Protestante, Lyon, France
[13] CHU Lille, F-59037 Lille, France
[14] CHU Montpellier, Montpellier, France
[15] Clin St Gatien, Tours, France
[16] CHU Lyon, Bron, France
[17] Hop Clairval, Marseille, France
[18] Hop St Joseph, Marseille, France
[19] Hop Enfants La Timone, Marseille, France
[20] Hop Marie Lannelongue, F-92350 Le Plessis Robinson, France
[21] CHU Besancon, F-25030 Besancon, France
[22] Ctr Cardiol Nord, St Denis, France
[23] CHU Bordeaux, Bordeaux, France
[24] CHU Nantes, F-44035 Nantes 01, France
[25] CHU Angers, Angers, France
[26] CHU Clermont Ferrand, Clermont Ferrand, France
[27] Parly 2, Le Chesnay, France
[28] CHU Strasbourg, F-67000 Strasbourg, France
[29] CHU Caen, F-14000 Caen, France
[30] Polyclin Bois Bernard, Bois Bernard, France
[31] CHU Grenoble, F-38043 Grenoble, France
[32] CHU Dupuytren, Limoges, France
[33] Ctr Cardiothorac, Monte Carlo, Monaco
关键词
OUTCOME SOURCE REGISTRY; VALVULAR HEART-DISEASE; EUROPEAN REGISTRY; STENOSIS; REPLACEMENT; SOCIETY; PROSTHESIS; GUIDELINES; MANAGEMENT; COREVALVE;
D O I
10.1056/NEJMoa1114705
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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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收藏
页码:1705 / 1715
页数:11
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