Assessment of long-term structural deterioration of transcatheter aortic bioprosthetic valves using standardized new European definitions, a multicenter French study

Abstract

In the context of extension of transcatheter aortic valve implantation (TAVI) indications to lower-risk patients, long-term durability of transcatheter aortic bioprosthetic valves (TABV) is a crucial issue. There is a paucity of data, especially beyond 5 years of follow-up. Recently, new definitions have been proposed to assess structural valve deterioration (SVD) and bioprosthetic valve failure (BVF). We aim to assess long-term SVD and BVF of TABV using standardized new definitions. All TAVI patients implanted between 2002 and 2011 in 5 French centers were included. One month and last available echocardiographic follow-up were used to assess SVD and BVF of according to the new European criteria. Competing-risk analysis was used to assess SVD and BVF incidence. From 2002 to 2011, 1403 patients were included. Mean age and logistic EuroSCORE were 82.6 ± 7.5 years and 21.3 ± 7.5%. Mean duration follow-up was 3.6 ± 2.1 years with a maximum of 10.2 years. Survival rates were 83.5% (95% CI: 81.4–85.5), 18.6% (95% CI: 15.3–21.8) and 8.0% (95% CI: 1.9–14.2) at 1, 7 and 10 years, respectively. BVF occurred in 18 patients of whom 5 required reoperation with a mean delay of 5.5 ± 1.3 years. Incidence of BVF was 2.2% (95% CI: 1.2–3.7) and 3.4 (95% CI: 1.7–5.9) at 7 and 10 years, respectively. Among 589 patients eligible for the SVD analysis, 41 had moderate SVD and 15 had severe SVD. Incidence of moderate SVD was 9.2% (95% CI: 6.5–12.6) and 16.6% (95% CI: 9.1–26.0) at 7 and 10 years, respectively. Incidence of severe SVD was 4.4% (95% CI: 2.2–7.9) and 8.0% (95% CI: 3.3–15.2) at 7 and 10 years, respectively. Despite the low survival rates of the early treated TAVI population in France, we believe reporting the longest follow-up available. Our study does not highlight any alarm signal concerning late durability of TABV. Further studies are warranted to assess long-term durability of TABV particularly in younger and lower risk-patients.