Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis
Thomas M. Beaver, Joseph E. Bavaria, Bartley P. Griffith, Lars G. Svensson, Philippe Pîbarot, Michael A. Borger, Omar M. Sharaf, David Heimansohn, Vinod H. Thourani, Eugene H. Blackstone, John D. Puskas
Abstract
Objective As bioprosthetic aortic valve replacement (AVR) extends to younger cohorts, tissue durability is of paramount importance. We report 7-year outcomes from an AVR bioprosthesis utilizing novel tissue. Methods International Investigational Device Exemption trial for novel AVR with annual follow-up and a subset re-consented at 5 years for extended 10-year follow-up. Safety endpoints and echocardiographic measurements were adjudicated by an independent clinical events committee and by a dedicated core laboratory, respectively. Results Between 1/2013 and 3/2016, 689 patients underwent AVR with the study valve. Mean age was 66.9±11.6 years, STS risk score was 2.0±1.8%, and 74.3% of patients were NYHA Class II and III. Five-year follow-up was completed by 512 patients, and 225 reconsented for extended follow-up. Follow-up duration was 5.3±2.2 years (3,665.6 patient-years), and 194 and 195 patients completed 6- and 7-year follow-ups, respectively. One-, 5-, and 7-year freedom from all-cause mortality was 97.7%, 89.4%, and 85.4%, respectively. Freedom from structural valve deterioration at 7 years was 99.3%. At 7 years, effective orifice area and mean gradients were 1.82±0.57 cm2 (n=153), and 9.4±4.5 mmHg (n=157), respectively. At 7 years, predominantly none (96.8%, n=152/157) or trivial/trace (2.5%, n=4/157) paravalvular regurgitation and none (84.7%, n=133/157) or trivial/trace (11.5%, n=18/157) transvalvular regurgitation were observed. Conclusions We report the longest surgical AVR follow-up with novel tissue in an IDE trial utilizing an independent clinical events committee and an echocardiography core laboratory. This tissue demonstrates excellent outcomes through 7 years and is the benchmark for future surgical and transcatheter prostheses.