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

Martine Gilard (1) , Hélène Eltchaninoff (2, 3) , Patrick Donzeau-Gouge (4) , Karine Chevreul (5, 6) , Jean Fajadet (7) , Pascal Leprince (8) , Alain Leguerrier (9, 10) , Michel Lievre (11) , Alain Prat , Emmanuel Teiger (12, 13, 14) , Thierry Lefèvre , Didier Tchetche , Didier Carrie (15, 16, 17) , Dominique Himbert (18) , Bernard Albat (19) , Alain Cribier (2) , Arnaud Sudre (20) , Didier Blanchard (21) , Gilles Rioufol (22) , Frederic Collet , Remi Houel , Pierre dos Santos (23) , Nicolas Meneveau (24) , Said Ghostine , Thibaut Manigold , Philippe Guyon , Dominique Grisoli , Hervé Le Breton (25) , Stephane Delpine , Romain Didier , Xavier Favereau , Geraud Souteyrand , Patrick Ohlmann , Vincent Doisy , Gilles Grollier (26) , Antoine Gommeaux , Jean-Philippe Claudel , Francois Bourlon , Bernard Bertrand , Marc Laskar (27, 28) , Bernard Iung (29)

1 ORPHY (EA 4324) - Optimisation des régulations physiologiques
2 Service de cardiologie [CHU Rouen]
3 EnVI - Nouvelles Cibles Pharmacologiques de la Protection Endothéliale et de l'Insuffisance Cardiaque
4 ICPS - Institut Cardiovasculaire Paris Sud
5 APHP URC-Eco Ile de Frabce
6 ECEVE (U1123 / UMR_S_1123) - Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables
7 Clinique Pasteur
8 Service de Chirurgie cardiaque et thoracique [CHU Pitié-Salpêtrière]
9 Service de chirurgie thoracique cardiaque et vasculaire [Rennes] = Thoracic and Cardiovascular Surgery [Rennes]
10 LTSI - Laboratoire Traitement du Signal et de l'Image
11 Evaluation et modélisation des effets thérapeutiques
12 CHU Henri Mondor - Département de physiologie
13 IMRB - Institut Mondor de Recherche Biomédicale
14 Service de cardiologie
15 Service Cardiologie [CHU Toulouse]
16 I2MR - Institut de médecine moléculaire de Rangueil
17 I2MC - Institut des Maladies Métaboliques et Cardiovasculaires
18 Service de cardiologie
19 Service de chirurgie thoracique et cardio-vasculaire
20 CHRU Lille - Centre Hospitalier Régional Universitaire [Lille]
21 Pôle Cardiologie Interventionnelle / Coro-scanner / IRM Cardiaque
22 Hôpital Cardiovasculaire Louis Pradel
23 Université Bordeaux Segalen - Bordeaux 2
24 UFC - Université de Franche-Comté
25 Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes]
26 Service de cardiologie et de pathologie vasculaire [CHU Caen]
27 Service de Chirurgie Thoracique et Vasculaire - Médecine vasculaire [CHU Limoges]
28 ERMA - Equipe de Recherche Médicale Appliquée
29 CHU de Montpellier

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.

Keywords: survival; stenosis; predictors; 2-year outcomes; late clinical-outcomes; permanent pacemaker implantation; corevalve; impact; mortality; long-term outcomes

Domains: Life Sciences [q-bio]

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⟩