Propensity-adjusted 8-year outcomes following bioprosthetic aortic valve replacement: The influence of novel anticalcification technology

Objective Aortic bioprostheses with RESILIA (Edwards Lifesciences) tissue technology have demonstrated robust outcomes through 7 years of follow-up. However, studies comparing RESILIA tissue valve outcomes to previous bioprosthetic valves are lacking. We sought to assess surgical aortic valve replacement outcomes in patients implanted with RESILIA tissue valves compared with non-RESILIA valves (PERIMOUNT Magna Ease with ThermaFix treatment; Edwards Lifesciences) at 8 years using data from 2 single-arm trials. Methods The analysis consisted of 689 RESILIA patients from the Prospective, Non-Randomized, Multicenter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE) Aortic trial and 258 non-RESILIA surgical aortic valve replacement patients from the Magna Ease postapproval study. To account for differences in baseline characteristics in these cohorts, stabilized inverse probability of treatment weighting with propensity score was used to analyze safety endpoints, including structural valve deterioration (SVD), reoperation due to SVD, all-cause reoperation, and all-cause mortality. Results Mean age of the propensity score-adjusted cohort was 67 years, with a majority of male patients. After adjustment, all prespecified clinically relevant baseline variables were appropriately matched. At 8 years, the RESILIA cohort significantly outperformed non-RESILIA valves in freedom from reoperation (97.0% vs 90.5%; P = .0014), reoperation due to SVD (99.2% RESILIA vs 93.9% non-RESILIA; P = .0007), and SVD (99.3% vs 90.5%; P < .0001). Freedom from all-cause mortality was not statistically different between cohorts (83.3% RESILIA vs 81.3% non-RESILIA; P = .6332). Conclusions In this propensity-adjusted patient population, surgical aortic valve replacement with this novel tissue treatment was associated with significantly lower rates of SVD, reoperation due to SVD, and all-cause reoperation at 8 years, with similar rates of all-cause mortality.