Registry of transcatheter aortic-valve implantation in high-risk patients.
Martine Gilard
(1)
,
Hélène Eltchaninoff
,
Bernard Iung
(2)
,
Patrick Donzeau-Gouge
,
Karine Chevreul
,
Jean Fajadet
,
Pascal Leprince
(3)
,
Alain Leguerrier
(4)
,
Michel Lievre
(5)
,
Alain Prat
,
Emmanuel Teiger
(6)
,
Thierry Lefevre
,
Dominique Himbert
(2)
,
Didier Tchetche
,
Didier Carrié
(7)
,
Bernard Albat
(8)
,
Alain Cribier
(9)
,
Gilles Rioufol
(10)
,
Arnaud Sudre
,
Didier Blanchard
,
Frederic Collet
,
Pierre dos Santos
(11)
,
Nicolas Meneveau
,
Ashok Tirouvanziam
(12)
,
Christophe Caussin
,
Philippe Guyon
,
Jacques Boschat
(1)
,
Herve Le Breton
,
Frederic Collart
,
Remi Houel
,
Stephane Delpine
,
Geraud Souteyrand
,
Xavier Favereau
,
Patrick Ohlmann
,
Vincent Doisy
,
Gilles Grollier
,
Antoine Gommeaux
,
Jean-Philippe Claudel
,
Francois Bourlon
,
Bernard Bertrand
(13)
,
Eric van Belle
(14)
,
Marc Laskar
(15, 16, 17)
,
Non Renseigné
1
ORPHY (EA 4324) -
Optimisation des régulations physiologiques
2 Service de cardiologie
3 CHU Pitié-Salpêtrière [AP-HP]
4 Service de chirurgie thoracique cardiaque et vasculaire [Rennes] = Thoracic and Cardiovascular Surgery [Rennes]
5 Evaluation et modélisation des effets thérapeutiques [LBBE]
6 IMRB - Institut Mondor de Recherche Biomédicale
7 Service Cardiologie [CHU Toulouse]
8 Service de chirurgie thoracique et cardio-vasculaire
9 Service de Cardiologie [CHU Rouen]
10 Hôpital Cardiovasculaire Louis Pradel
11 Université Bordeaux Segalen - Bordeaux 2
12 ITX - ITX - unité de recherche de l'institut du thorax
13 Neurosciences Sensorielles Comportement Cognition
14 Interface sang vaisseaux et réparation cardiovasculaire
15 Service de Chirurgie Thoracique et Vasculaire - Médecine vasculaire [CHU Limoges]
16 UNILIM - Université de Limoges
17 ERMA - Equipe de Recherche Médicale Appliquée
2 Service de cardiologie
3 CHU Pitié-Salpêtrière [AP-HP]
4 Service de chirurgie thoracique cardiaque et vasculaire [Rennes] = Thoracic and Cardiovascular Surgery [Rennes]
5 Evaluation et modélisation des effets thérapeutiques [LBBE]
6 IMRB - Institut Mondor de Recherche Biomédicale
7 Service Cardiologie [CHU Toulouse]
8 Service de chirurgie thoracique et cardio-vasculaire
9 Service de Cardiologie [CHU Rouen]
10 Hôpital Cardiovasculaire Louis Pradel
11 Université Bordeaux Segalen - Bordeaux 2
12 ITX - ITX - unité de recherche de l'institut du thorax
13 Neurosciences Sensorielles Comportement Cognition
14 Interface sang vaisseaux et réparation cardiovasculaire
15 Service de Chirurgie Thoracique et Vasculaire - Médecine vasculaire [CHU Limoges]
16 UNILIM - Université de Limoges
17 ERMA - Equipe de Recherche Médicale Appliquée
Hélène Eltchaninoff
- Function : Author
Patrick Donzeau-Gouge
- Function : Author
Karine Chevreul
- Function : Author
Jean Fajadet
- Function : Author
Alain Prat
- Function : Author
Thierry Lefevre
- Function : Author
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
- Function : Author
- PersonId : 768289
- ORCID : 0000-0003-4247-7184
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
Eric van Belle
- Function : Author
- PersonId : 953380
- ORCID : 0000-0001-5631-5341
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.).