Presentation (CTI)

OBJECTIVES: Transcatheter aortic valve replacement (TAVR) is increasingly popular for treating aortic stenosis in South Korea. The latest TAVR valves use RESILIA, a bovine pericardial tissue treated with integrity-preservation technology. This involves chemically blocking residual free aldehyde groups to prevent calcium binding and glycerolisation to replace water with glycerol, protecting against structural valve deterioration (SVD) and enhancing durability. RESILIA is incorporated into the newest balloon-expandable valves on the SAPIEN platform. Although this new tissue increases valve costs, a recent study shows it offers a survival benefit compared to previous valve generations (HR=0.79, 95% CI 0.67, 0.93). The study aims to evaluate the cost-utility of the SAPIEN 3 Ultra RESILIA (S3UR) valve versus earlier SAPIEN valves (S3 and S3U) for treating aortic stenosis in South Korea.
METHODS: A Markov model with two health states (alive, dead) was developed with 2-week cycles. Survival curves from a clinical trial were reconstructed through digitisation and a published algorithm. Survival was extrapolated to 10 years; Korean specific health state utilities and disease management costs were obtained from published sources. Deterministic and probabilistic sensitivity analyses were performed to test the robustness of the results.
RESULTS: S3UR added 0.26 years of life (LYs) and 0.23 quality adjusted life years (QALYs) at an additional cost of KRW 6M (approximately EUR 3,800) discounted, resulting in ICERs of KRW 23.5M/LY saved and KRW 26.4M/QALY saved. The sensitivity analysis showed that the ICER was most sensitive to cost S3UR and the hazard ratio of survival. However, the ICER was stable and 96.2% of the simulations in the PSA were below a KRW39.9M threshold.
CONCLUSIONS: S3UR represents a cost-effective alternative to previous generations of valves with potential improvement in quality of life and survival for aortic stenosis patients in South Korea.