Long-term clinical outcomes 15 years after aortic valve replacement with the Freestyle stentless aortic bioprosthesis.

Background: The Freestyle stentless aortic root bioprosthesis has excellent hemodynamics and durability through 10 years. The purpose of this report is to present clinical outcomes in a large multicenter cohort through 15 years.

Methods: The multicenter evaluation of the Freestyle valve began in 1992 at 21 centers in North America and Europe. In 1997, a long-term study continued, including 725 patients from 8 of the original centers; clinical outcomes data after 10 years have continued to be collected at 6 of 8 centers.

Results: Patient age was 71.7±7.9 years. There were 402 (55.4%) men and 323 (44.6%) women. Total follow-up was 5,491.2 patient-years. There were 52 late reoperations, with explant of the bioprosthesis in 47 cases. Respective 10- and 15-year survival was 46.2%±2.3% and 25.9%±3.2%; freedom from valve-related death was 94.9%±1.5% and 92.7%±3.5%; freedom from reoperation was 92.3%±1.8% and 80.7%±5.0%; and freedom from explant owing to structural valve deterioration was 96.5%±1.3% and 83.3%±4.8%. Increased age was associated with higher risks of all-cause mortality and valve-related mortality and lower risks of reoperation and explant caused by structural valve deterioration.

Conclusions: In this long-term, multicenter, observational study, the Freestyle stentless aortic root bioprosthesis offered good clinical outcomes in terms of survival, freedom from valve-related mortality, freedom from reoperation, and freedom from structural valve deterioration. The Freestyle valve is a viable option for use in patients undergoing bioprosthetic aortic valve replacement and for anticipated desire for long-term durability.