Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis

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: This was an 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 end points and echocardiographic measurements were adjudicated by an independent clinical events committee and by a dedicated core laboratory, respectively. Results: Between January 2013 and March 2016, 689 patients underwent AVR with the study valve. Mean age was 66.9 +/- 11.6 years, Society of Thoracic Surgeons risk score was 2.0% % +/- 1.8%, % , and 74.3% % of patients were New York Heart Association functional class II and III. Five-year follow-up was completed by 512 patients, and 225 re-consented for extended follow-up. Follow-up duration was 5.3 +/- 2.2 years (3665.6 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 fi ce area and mean gradients were 1.82 +/- 0.57 cm(2) (n = 153), and 9.4 +/- 4.5 mm Hg (n = 157), respectively. At 7 years, predominantly none (96.8% % [152 out of 157]) or trivial/trace (2.5% % [4 out of 157]) paravalvular regurgitation and none (84.7% % [133 out of 157]) or trivial/trace (11.5% % [18 out of 157]) transvalvular regurgitation were observed. Conclusions: We report the longest surgical AVR follow-up with novel tissue in an investigational device exemption 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.