Registry of transcatheter aortic-valve implantation in high-risk patients.
|Title||Registry of transcatheter aortic-valve implantation in high-risk patients.|
|Publication Type||Journal Article|
|Year of Publication||2012|
|Authors||Gilard, M., H. Eltchaninoff, B. Iung, P. Donzeau-Gouge, K. Chevreul, J. Fajadet, P. Leprince, A. Leguerrier, M. Lievre, A. Prat, E. Teiger, T. Lefevre, D. Himbert, D. Tchetche, D. Carrié, B. Albat, A. Cribier, G. Rioufol, A. Sudre, D. Blanchard, F. Collet, P. Dos Santos, N. Meneveau, A. Tirouvanziam, C. Caussin, P. Guyon, J. Boschat, H. Le Breton, F. Collart, R. Houel, S. Delpine, G. Souteyrand, X. Favereau, P. Ohlmann, V. Doisy, G. Grollier, A. Gommeaux, J. - P. Claudel, F. Bourlon, B. Bertrand, E. Van Belle, and M. Laskar|
|Corporate Authors||FRANCE 2 Investigators|
|Journal||The New England journal of medicine|
|Date Published||2012 May 3|
|Keywords||Aged, Aged, 80 and over, Aortic Valve Stenosis, Cardiac Catheterization, Female, France, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Hemorrhage, Humans, Incidence, Male, Multivariate Analysis, Prospective Studies, Registries, Stroke|
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.).
|Alternate Journal||N. Engl. J. Med.|