Registry of transcatheter aortic-valve implantation in high-risk patients. - Université de Bretagne Occidentale Access content directly
Journal Articles New England Journal of Medicine Year : 2012

Registry of transcatheter aortic-valve implantation in high-risk patients.

Hélène Eltchaninoff
  • Function : Author
Bernard Iung
Patrick Donzeau-Gouge
  • Function : Author
Karine Chevreul
  • Function : Author
Jean Fajadet
  • Function : Author
Alain Prat
  • Function : Author
Thierry Lefevre
Didier Tchetche
  • Function : Author
Arnaud Sudre
  • Function : Author
Didier Blanchard
  • Function : Author
Frederic Collet
  • Function : Author
Nicolas Meneveau
  • Function : Author
Christophe Caussin
  • Function : Author
Philippe Guyon
  • Function : Author
Herve Le Breton
  • Function : Author
Frederic Collart
Remi Houel
  • Function : Author
Stephane Delpine
  • Function : Author
Geraud Souteyrand
  • Function : Author
Xavier Favereau
  • Function : Author
Patrick Ohlmann
  • Function : Author
Vincent Doisy
  • Function : Author
Gilles Grollier
  • Function : Author
Antoine Gommeaux
  • Function : Author
Jean-Philippe Claudel
  • Function : Author
Francois Bourlon
  • Function : Author
Non Renseigné
  • Function : Author

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.).

Dates and versions

hal-00811695 , version 1 (11-04-2013)

Identifiers

Cite

Martine Gilard, Hélène Eltchaninoff, Bernard Iung, Patrick Donzeau-Gouge, Karine Chevreul, et al.. Registry of transcatheter aortic-valve implantation in high-risk patients.. New England Journal of Medicine, 2012, 366 (18), pp.1705-15. ⟨10.1056/NEJMoa1114705⟩. ⟨hal-00811695⟩
869 View
0 Download

Altmetric

Share

Gmail Mastodon Facebook X LinkedIn More