Five-Year Outcomes After Bicuspid Aortic Valve Replacement With a Novel Tissue Bioprosthesis

This article examines the results of the COMMENCE trial, which evaluated the safety and effectiveness of surgical aortic valve replacement using RESILIA tissue valves during a five-year period in patients with native bicuspid aortic valves, comparing outcomes with those of patients with tricuspid aortic valves. 
 
Of the 689 patients in the COMMENCE trial, 645 had documented valve morphology and evaluable echocardiograms. A total of 214 patients had bicuspid aortic valves, while 458 had tricuspid valves. Notably, the bicuspid cohort was significantly younger, with an average age of 59.8 years compared to 70.2 years for the tricuspid cohort (P < .001). 
 
The results showed no structural valve deterioration in the bicuspid aortic valve group during the five years, along with low rates of paravalvular leak (0.7 percent) and transvalvular regurgitation (2.9 percent), all classified as mild. These findings were comparable to those observed in the tricuspid valve group. Additionally, linear mixed-effects models indicated that the estimated postoperative mean gradient and effective orifice area, and their changes over time, did not differ significantly between the two patient groups after adjusting for age, body surface area, and bioprosthesis size. 
 
In conclusion, RESILIA tissue valves demonstrated excellent durability and safety in patients with bicuspid aortic valves during the five-year follow-up period. The absence of structural valve deterioration and minimal rates of regurgitation are particularly promising, suggesting that RESILIA tissue could be a viable option for younger patients requiring aortic valve replacement.