Dr. Gerhard Schuler
Prof. Martine Gilard,
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BackgroundTreatment of high risk patients with severe aortic stenosis and co-morbidities is challenging. Transcatheter aortic valve implantation (TAVI) has revolutionized management. We report the results of the exhaustive prospective multicenter national French Transcatheter Aortic Valve Intervention Registry, FRANCE 2.
MethodsThe FRANCE 2 registry was established under the authority of the French Societies of Cardiology and Thoracic and Cardio-Vascular Surgery. All TAVIs perormed in France were included, and data were collected prospectively. The primary end-point of the study was mortality from any cause. The standardized outcome definitions of the Valve Academic Research Consortium (VARC) were used. Mortality was adjudicated by an independent clinical events committee.
ResultsA total of 3933 patients were enrolled between January 2010 and december 2011 in 34 centres. Mean age was 82.8+7 years; 49.5% were female. All patients were highly symptomatic and at high surgical risk; Edwards SAPIEN and Medtronic CoreValve devices were implanted in 67% and 33% of patients, respectively. Approaches were transarterial (transfemoral: 73%; subclavian: 6 %; transaortic: 1.62 ) or transapical (18%). Procedural success rate was 97%. Mortality at 30 days, 6 month and 1 year was respectively 9.5%, 18% and 24.1%. In a multivariate model, survival was significantly adversely affected by logistic Euroscore, Periprostheticregurgitation grade 2 or higher, trans apical approach, NYHA functional class, creatinemia > 200 μmol/L, dyslipidimia and previous Aortic surgery. We analyzed the evolution in patient and procedural characteristics between the 2 years of the registry (1575 pts in 2010, 2446 pts in 2011).
ConclusionThis is the largest prospective registry and reflects the real-life TAVI experience in high-risk elderly patients in France. TAVI appears to be a reasonable option for a selected population of inoperable or high-risk patients with severe aortic stenosis.
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711009 - 711010
Clinical Trial & Registry Update III: Updates on Atrial Fibrillation and Valves
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