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Assessment of structural valve deterioration of transcatheter aortic bioprosthetic balloon-expandable valves using the new European consensus definition

1. Rouen University Hospital, Department of Cardiology, FHU REMOD-VHF, Rouen, France; 2. Normandie Univ, UNIROUEN, INSERM U1096, Rouen, France; 3. Rouen University Hospital, Department of Thoracic and Cardiovascular Surgery, Rouen, France; 4. Rouen University Hospital, Department of Radiology, Cardiac Imaging Unit, FHU REMOD-VHF, Rouen, France; 5. Department of Biostatistics, Edwards Lifesciences, Nyon, Switzerland

Aims: Durability of transcatheter aortic bioprosthetic valves remains a major issue. Standardised definitions of deterioration and failure of bioprosthetic valves have recently been proposed. The aim of this study was to assess structural transcatheter valve deterioration (SVD) and bioprosthetic valve failure (BVF) using these new definitions.

Methods and results: All TAVI patients implanted up to September 2012 with a minimal theoretical five-year follow-up were included. Systematic clinical and echocardiographic follow-up was performed annually. New standardised definitions were used to assess durability of transcatheter aortic bioprosthetic valves. From 2002 to 2012, 378 patients were included. Mean age and logistic EuroSCORE were 83.3±6.8 years and 22.8±13.1%. Thirty-day mortality was 13.2%. Nine patients had SVD including two severe forms and two patients had definite late BVF. The incidence of SVD and BVF at eight years was 3.2% (95% CI: 1.45-6.11) and 0.58% (95% CI: 0.15-2.75), respectively.

Conclusions: Even though limited by the poor survival of the very high-risk/compassionate early population, our data do not demonstrate any alarm concerning transcatheter aortic valve durability. Careful prospective assessment in younger and lower-risk patients and comparison with surgical bioprosthetic valves are required for further assessment of the long-term durability of transcatheter valves.

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