Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry

• Published in: European heart journal Vol. 32; no. 2; pp. 191 - 197
• Main Authors: ELTCHANINOFF, Hélène, PRAT, Alain, PAVIE, Alain, GUERET, Pascal, GILARD, Martine, LEGUERRIER, Alain, BLANCHARD, Didier, FOURNIAL, Gérard, LUNG, Bernard, DONZEAU-GOUGE, Patrick, TRIBOUILLOY, Christophe, DEBRUX, Jean-Louis
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01-01-2011; Oxford University Press (OUP)
• Subjects: Aged; Aged, 80 and over; Analysis of Variance; Aortic Valve; Aortic Valve - surgery; Aortic Valve Stenosis; Aortic Valve Stenosis - surgery; Biological and medical sciences; Cardiac Catheterization; Cardiac Catheterization - methods; Cardiology. Vascular system; Endocardial and cardiac valvular diseases; Female; France; Heart; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Heart Valve Prosthesis Implantation - methods; Human health and pathology; Humans; Life Sciences; Male; Medical sciences; Middle Aged; Postoperative Complications; Postoperative Complications - etiology; Registries; Tissues and Organs; Treatment Outcome; France; Europe; Aortic stenosis; Transcatheter aortic valve implantation; Cardiac valvular disease; Cardiovascular disease; Aorta; Implantation; Early; Circulatory system; Cardiology; Aortic valve; Result
• ISSN: 0195-668X; 1522-9645
• DOI: 10.1093/eurheartj/ehq261

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.
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.
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.