Long-Term Outcomes of a Self-Expanding Transcatheter Heart Valve.

Background: Data on long-term outcomes and durability of the ACURATE neo valve are limited. This study aimed to obtain long-term outcome and echocardiographic data among ACURATE neo recipients. Methods: Consecutive patients undergoing transfemoral transcatheter aortic valve implantation for severe native aortic stenosis from 4 centers using the ACURATE neo valve between 2012 and 2018 (n = 961) were included. Exclusion criteria for the durability analysis were 30-day mortality, valve-in-valve implantation or surgical aortic valve replacement within 30 days, and lack of echocardiographic follow-up (FU) beyond 30 days, leaving 758 patients included in the durability cohort. Primary endpoints were the cumulative incidence of late bioprosthetic valve failure (BVF), structural valve deterioration (SVD), and Kaplan-Meier estimates of all-cause mortality. Results: In the overall cohort (median age of 82 years, 61.3% females, median and maximum FU time of 5.0 and 11.3 years), estimates of all-cause mortality at 1, 5, and 8 years were 13.6, 43.1, and 67.3%, respectively. In the durability cohort, the cumulative incidence was 3.5% for moderate SVD, 2.1% for severe SVD, and 3.2% for BVF at 8 years. Paired FU echocardiography beyond 5 years (n = 243, median FU time of 6.4 years) showed mean aortic valve gradients and effective orifice area of 9 mmHg and 1.8 cm Conclusions: In this multicenter observational cohort treated with the ACURATE neo platform, 8-year survival was 32.7%, and the cumulative incidence of severe SVD (2.1%) and BVF (3.2%) was limited. These findings provide long-term durability estimates in an elderly, real-world population.