학술논문
Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry
Document Type
Academic Journal
Author
Eltchaninoff, Hélène; Prat, Alain; Gilard, Martine; Leguerrier, Alain; Blanchard, Didier; Fournial, Gérard; Iung, Bernard; Donzeau-Gouge, Patrick; Tribouilloy, Christophe; Debrux, Jean-Louis; Pavie, Alain; Gueret, Pascal; Leprince, P; Beygui, F; Collet, J-P; Himbert, D; Nataf, P; Vahanian, A; Lefevre, T; Romano, M; Eltchaninoff, H; Litzler, P-Y; Bessou, J-P; Cribier, A; Fajadet, J; Carrie, D; Berthoumieu, P; Dumonteil, N; Fournial, G; Teiger, E; Dubois Randé, J-L; Kirsch, M; Blanchard, D; Fabiani, J-N; Sudre, A; Modine, T; Dos Santos, P; Guibaud, J-P; Roques, X; Gilard, M; Boschat, J; Bezon, E; Schiele, F; Chocron, S; Meneveau, N; Bassand, JP; Rioufol, G; Obadia, J-F; Tirouvanziam, A; Roussel, J-C; Crochet, D; Collard, F; Bonnet, J-L; Cuisset, T; Wolf, J-E; Bouchot, O; Gueret, P; Pavie, A; Blanchard, D; Debrux, J-L; Donzeau-Gouge, P; Eltchaninoff, H; Gilard, M; Iung, B; Leguerrier, A; Prat, A; Tribouilloy, C; Chevreul, K
Source
European Heart Journal. Jan 01, 2011 32(2):191-197
Subject
Language
English
ISSN
0195-668X
Abstract
AIMS: Transcatheter aortic valve implantation is a therapeutic alternative for high-surgical-risk patients with severe symptomatic aortic stenosis. Two models of prosthesis are currently commercialized in France, which can be implanted either via a transarterial or a transapical approach. The aim of the study was to evaluate in a national French registry the early safety and efficacy of transcatheter aortic valve replacement (AVR) using either the Edwards SAPIEN™ or CoreValve™ in high-surgical-risk patients with severe aortic stenosis. METHODS AND RESULTS: The multicentre national registry was conducted in 16 centres between February 2009 and June 2009, under the authority of the French Societies of Cardiology and Thoracic and Cardio-Vascular Surgery. The primary endpoint was mortality at 1 month. Two hundred and forty-four high-surgical-risk patients (logistic EuroSCORE ≥20%, STS ≥10%, or contra-indication to AVR) were enrolled. Mean age was 82 ± 7 years and 43.9% were female. Edwards SAPIEN and CoreValve were implanted in 68 and 32% of patients, respectively. The approaches used were transarterial (transfemoral: 66%; subclavian: 5%) or transapical in 29%. Device success rate was 98.3% and 30-day mortality was 12.7%. Severe complications included stroke (3.6%), tamponade (2%), acute coronary occlusion (1.2%), and vascular complications (7.3%). Pacemaker was required in 11.8%. At 1 month, 88% of patients were in NYHA class II or less. CONCLUSION: This prospective registry reflects the real-life experience of transcatheter aortic valve implantation in high-risk elderly patients in France. The early results are satisfactory in terms of feasibility, short-term haemodynamic and functional improvement, and safety. Longer term follow-up will be further assessed.