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Journal Articles Journal of the American College of Cardiology Year : 2016

Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients The FRANCE-2 Registry

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Jean Fajadet
  • Function : Author
Alain Prat
  • Function : Author
Thierry Lefèvre
  • Function : Author
Didier Tchetche
  • Function : Author
Frederic Collet
  • Function : Author
Remi Houel
  • Function : Author
Said Ghostine
  • Function : Author
Thibaut Manigold
  • Function : Author
Philippe Guyon
  • Function : Author
Dominique Grisoli
  • Function : Author
Stephane Delpine
  • Function : Author
Romain Didier
Xavier Favereau
  • Function : Author
Geraud Souteyrand
  • Function : Author
Patrick Ohlmann
  • Function : Author
Vincent Doisy
  • Function : Author
Antoine Gommeaux
  • Function : Author
Jean-Philippe Claudel
  • Function : Author
Francois Bourlon
  • Function : Author
Bernard Bertrand
  • Function : Author
Bernard Iung

Abstract

BACKGROUND Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up. OBJECTIVES This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. METHODS The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used. RESULTS A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade >= 2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in < 2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up. CONCLUSIONS The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time. (J Am Coll Cardiol 2016; 68: 1637-47) (C) 2016 by the American College of Cardiology Foundation.

Dates and versions

hal-01414473 , version 1 (12-12-2016)

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Cite

Martine Gilard, Hélène Eltchaninoff, Patrick Donzeau-Gouge, Karine Chevreul, Jean Fajadet, et al.. Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients The FRANCE-2 Registry. Journal of the American College of Cardiology, 2016, 68 (15), pp.1637--1647. ⟨10.1016/j.jacc.2016.07.747⟩. ⟨hal-01414473⟩
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