RESUMO
BACKGROUND: Prior economic analyses demonstrate that legacy tissue valves are associated with substantial financial savings over the long run after a surgical aortic valve replacement (SAVR). Bioprostheses with RESILIA tissue reduce calcification, the primary cause of structural valve deterioration (SVD), and have demonstrated promising pre-clinical and 5-year clinical results. This economic evaluation quantifies the expected long-run savings of bioprosthetic valves with RESILIA tissue relative to mechanical valves given 5-year clinical results and expected performance through year 15. METHODS: Simulation models estimated disease progression across two hypothetical SAVR cohorts (tissue vs. mechanical) of 10,000 patients in the US over 15 years. One comparison evaluated RESILIA tissue valves relative to mechanical valves. The other compared legacy SAVR tissue and mechanical valves. Health outcome probabilities and costs were based on literature and expert opinion. Incidence rates of health outcomes associated with mechanical valve were calculated using relative risks of expected outcomes in tissue valve versus mechanical valve patients. The comparisons also accounted for anti-coagulation monitoring in both cohorts. Savings estimates are based on US healthcare costs and do not yet account for the premium associated use of RESILIA relative to a standard tissue valve. RESULTS: Relative to mechanical SAVR, the median net discounted savings for a patient receiving SAVR with a RESILIA tissue valve is $20,744 ($US, 2020; 95% CI = $15,835-$26,655) over a 15-year horizon. While 30-day and 1-year savings were not significant, expected savings after 5 years are $9,110 (95% CI = $6,634-$11,969). Net savings for RESILIA SAVR valves were approximately 30-50% larger than savings anticipated using legacy tissue SAVR valves. CONCLUSION: RESILIA tissue valves are associated with lower health expenditures relative to mechanical valves.
