title: Registry of transcatheter aortic-valve implantation in high-risk patients.
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.).
authors.affiliation: Centre Hospitalier Universitaire (CHU) Brest, Brest, France. martine.gilard@chu-brest.fr
authors.forename: Martine
authors.initials: M
authors.lastname: Gilard
authors.forename: Hélène
authors.initials: H
authors.lastname: Eltchaninoff
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authors.forename: Didier
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authors.forename: Stephane
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authors.forename: Geraud
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authors.lastname: Souteyrand
authors.forename: Xavier
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authors.lastname: Favereau
authors.forename: Patrick
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authors.lastname: Ohlmann
authors.forename: Vincent
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authors.lastname: Doisy
authors.forename: Gilles
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authors.lastname: Grollier
authors.forename: Antoine
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authors.lastname: Gommeaux
authors.forename: Jean-Philippe
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authors.lastname: Claudel
authors.forename: Francois
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authors.lastname: Bourlon
authors.forename: Bernard
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mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000150:complications / Q000628:therapy*; D006328:Cardiac Catheterization / Q000379:methods; D005260:Female; D005602:France / Q000453:epidemiology; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D006470:Hemorrhage / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D015994:Incidence; D008297:Male; D015999:Multivariate Analysis; D011446:Prospective Studies; D012042:Registries; D020521:Stroke / Q000453:epidemiology / Q000209:etiology