Five-Year Results of Aortic Valve Replacement With a Novel Bioprosthesis: Real-World Data From a Large Multicenter Registry

Background: The clinical performance and safety of a glutaraldehyde-free bioprosthetic valve using a novel tissue treatment in a large real-world patient population have not previously been reported. Methods: This is a prospective, multicenter, real-world registry of all patients undergoing surgical aortic valve replacement with a novel bioprosthesis at 7 European cardiac surgery centers. The primary end point was the 5-year freedom from structural valve deterioration per Valve Academic Research Consortium 3 criteria. Secondary end points included hemodynamic performance of the bioprosthesis and freedom from all-cause and cardiovascular mortality, prosthetic endocarditis, stroke, and reintervention at 5 years. Results: A total of 498 patients were included in the analysis; the mean age was 60.1 years, with a mean EuroSCORE II of 3.9% and 27.9% being female. The median follow-up was 4.8 years. Five-year freedom from structural valve deterioration stages 1, 2, and 3 was 95.7%, 98.6%, and 99.3%, respectively. The estimated 5-year overall survival was 93.2%; freedom from cardiovascular mortality was 97.2%. Event-free probabilities at 5 years for endocarditis, stroke, and reintervention were 98.6%, 98.1%, and 98.2%, respectively. Moderate-severe paravalvular leakage was infrequent (97.3% event-free probability at 5 years), and mean aortic valve pressure gradient was stable compared with discharge (median, 11.0 mm Hg at discharge vs 12.0 mm Hg at 5 years). Conclusions: These real-world clinical data of a novel aortic bioprosthesis demonstrated good 5-year results for both durability and safety outcomes as well as stable hemodynamic valve performance.