Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry.
OBJECTIVE
Transcatheter aortic valve implantation is a therapeutic alternative for high-surgical-risk patients with severe symptomatic aortic stenosis. Two models of prosthesis are currently commercialized in France, which can be implanted either via a transarterial or a transapical approach. The aim of the study was to evaluate in a national French registry the early safety and efficacy of transcatheter aortic valve replacement (AVR) using either the Edwards SAPIEN™ or CoreValve™ in high-surgical-risk patients with severe aortic stenosis.


RESULTS
The multicentre national registry was conducted in 16 centres between February 2009 and June 2009, under the authority of the French Societies of Cardiology and Thoracic and Cardio-Vascular Surgery. The primary endpoint was mortality at 1 month. Two hundred and forty-four high-surgical-risk patients (logistic EuroSCORE ≥20%, STS ≥10%, or contra-indication to AVR) were enrolled. Mean age was 82 ± 7 years and 43.9% were female. Edwards SAPIEN and CoreValve were implanted in 68 and 32% of patients, respectively. The approaches used were transarterial (transfemoral: 66%; subclavian: 5%) or transapical in 29%. Device success rate was 98.3% and 30-day mortality was 12.7%. Severe complications included stroke (3.6%), tamponade (2%), acute coronary occlusion (1.2%), and vascular complications (7.3%). Pacemaker was required in 11.8%. At 1 month, 88% of patients were in NYHA class II or less.


CONCLUSIONS
This prospective registry reflects the real-life experience of transcatheter aortic valve implantation in high-risk elderly patients in France. The early results are satisfactory in terms of feasibility, short-term haemodynamic and functional improvement, and safety. Longer term follow-up will be further assessed.
Eltchaninoff
Hélène
H
Cardiology Department, Charles Nicolle Hospital, University of Rouen-INSERM U644, 1 rue de Germont, Rouen Cedex, France. helene.eltchaninoff@chu-rouen.fr
Prat
Alain
A
Gilard
Martine
M
Leguerrier
Alain
A
Blanchard
Didier
D
Fournial
Gérard
G
Iung
Bernard
B
Donzeau-Gouge
Patrick
P
Tribouilloy
Christophe
C
Debrux
Jean-Louis
JL
Pavie
Alain
A
Gueret
Pascal
P
D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D006328:Cardiac Catheterization / Q000379:methods*; D005260:Female; D005602:France; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology*; D012042:Registries; D016896:Treatment Outcome