title: Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients: The FRANCE-2 Registry.
abstract: 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.
  
  
  
  This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Cardiology, Brest University Hospital, Brest, France. Electronic address: martine.gilard@chu-brest.fr.
authors.forename: Martine
authors.initials: M
authors.lastname: Gilard
authors.affiliation: Department of Cardiology, Rouen University Hospital, Rouen, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Eltchaninoff
authors.affiliation: Department of Cardiology and Surgery, Institut Cardiovasculaire Paris Sud, Massy, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Donzeau-Gouge
authors.affiliation: Department of URC-ECO and Cardiology, Creteil University Hospital, Paris, France.
authors.forename: Karine
authors.initials: K
authors.lastname: Chevreul
authors.affiliation: Department of Cardiology, Clinique Pasteur, Toulouse, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Fajadet
authors.affiliation: Department of Surgery, Pitié Salpetrière University Hospital, Paris, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Leprince
authors.affiliation: Department of Cardiology and Surgery, Rennes University Hospital, Rennes, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Leguerrier
authors.affiliation: UMR and Department of Cardiology, Lyon University Hospital, Lyon, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Lievre
authors.affiliation: Department of Cardiology and Surgery, Lille University Hospital, Lille, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Prat
authors.affiliation: Department of URC-ECO and Cardiology, Creteil University Hospital, Paris, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Teiger
authors.affiliation: Department of Cardiology and Surgery, Institut Cardiovasculaire Paris Sud, Massy, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefevre
authors.affiliation: Department of Cardiology, Clinique Pasteur, Toulouse, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Tchetche
authors.affiliation: Department of Cardiology, Toulouse University Hospital, Toulouse, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Carrié
authors.affiliation: Department of Cardiology, Bichat University Hospital, Paris, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Himbert
authors.affiliation: Department of Surgery, Montpellier University Hospital, Montpellier, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Albat
authors.affiliation: Department of Cardiology, Rouen University Hospital, Rouen, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Cribier
authors.affiliation: Department of Cardiology and Surgery, Lille University Hospital, Lille, France.
authors.forename: Arnaud
authors.initials: A
authors.lastname: Sudre
authors.affiliation: Department of Cardiology, Clinique St. Gatien, Tours, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Blanchard
authors.affiliation: UMR and Department of Cardiology, Lyon University Hospital, Lyon, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Rioufol
authors.affiliation: Department of Surgery, Hospital Clairval, Marseille, France.
authors.forename: Frederic
authors.initials: F
authors.lastname: Collet
authors.affiliation: Department of Surgery, Hospital Saint Joseph, Marseille, France.
authors.forename: Remi
authors.initials: R
authors.lastname: Houel
authors.affiliation: Department of Cardiology, Bordeaux University Hospital, Bordeaux, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Dos Santos
authors.affiliation: Department of Cardiology, Besancon University Hospital, Besancon, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Meneveau
authors.affiliation: Department of Cardiology, Centre Cardiologique Marie Lannelongue, Le Plessis Robinson, France.
authors.forename: Said
authors.initials: S
authors.lastname: Ghostine
authors.affiliation: Department of Cardiology, Nantes University Hospital, Nantes, France.
authors.forename: Thibaut
authors.initials: T
authors.lastname: Manigold
authors.affiliation: Department of Cardiology, Centre Cardiologique du Nord, Saint Denis, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Guyon
authors.affiliation: Department of Surgery, Marseille University Hospital, Marseille, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Grisoli
authors.affiliation: Department of Cardiology and Surgery, Rennes University Hospital, Rennes, France.
authors.forename: Herve
authors.initials: H
authors.lastname: Le Breton
authors.affiliation: Department of Cardiology, Angers University Hospital, Angers, France.
authors.forename: Stephane
authors.initials: S
authors.lastname: Delpine
authors.affiliation: Department of Cardiology, Brest University Hospital, Brest, France.
authors.forename: Romain
authors.initials: R
authors.lastname: Didier
authors.affiliation: Department of Cardiology, Parly 2 Hospital, Le Chesnay, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Favereau
authors.affiliation: Department of Cardiology, Clermont Ferrand University Hospital, Clermont Ferrand, France.
authors.forename: Geraud
authors.initials: G
authors.lastname: Souteyrand
authors.affiliation: Department of Cardiology, Strasbourg University Hospital, Strasbourg, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Ohlmann
authors.affiliation: Department of Surgery, Clinique du Tonkin, Lyon, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Doisy
authors.affiliation: Department of Cardiology, Caen University Hospital, Caen, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Grollier
authors.affiliation: Department of Cardiology, Hôpital Bois Bernard, Bois Bernard, France.
authors.forename: Antoine
authors.initials: A
authors.lastname: Gommeaux
authors.affiliation: Department of Cardiology, Infirmerie Protestante, Lyon, France.
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Claudel
authors.affiliation: Department of Cardiology, Centre Cardio-Thoracique, Monaco.
authors.forename: Francois
authors.initials: F
authors.lastname: Bourlon
authors.affiliation: Department of Cardiology, Grenoble University Hospital, Grenoble, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Bertrand
authors.affiliation: Department of Surgery, Limoges University Hospital, Limoges, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Laskar
authors.affiliation: Department of Cardiology, Bichat University Hospital, Paris, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Iung
mesh_terms: D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery*; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012042:Registries; D018570:Risk Assessment; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement; D016896:Treatment Outcome
keywords: aortic stenosis; predictive analysis; risk score