Abstract 156: Cost-Effectiveness Analysis of the Sentinel Cerebral Embolic Protection Device During Transcatheter Aortic Valve Replacement

Abstract

Introduction: Transcatheter aortic valve replacement (TAVR) has been established as a standard of care for patients with severe aortic stenosis deemed at prohibitive or high risk for surgery. However, stroke remains an unpredictable and devastating complication after TAVR. The Sentinel cerebral embolic protection (CEP) device has been shown to collect thrombus and debris in 99% of patients during TAVR and possibly lowers risk of clinically-overt periprocedural stroke. Methods: We performed a cost-effectiveness analysis comparing CEP vs no CEP using a Markov model with 3 health states (stroke-free, post-stroke, death) and simulated an average 83-year old high-risk TAVR patient cohort. Risk of stroke and mortality at 30 days with and without CEP (5.6 vs 9.0 and 1.3 vs 1.8%, respectively) were based on the SENTINEL trial. U.S. healthcare costs, utilities, and long-term survival following TAVR with or without stroke were based on the PARTNER and CoreValve US Pivotal trials. Sentinel device costs were based on the manufacturer’s cost estimate ($2,400). We performed a probabilistic sensitivity analysis accounting for parameter uncertainty and calculated lifetime costs and quality-adjusted life years (QALYs) at a discount rate of 3%. Results: CEP increased QALYs of 3.81 by 0.16 (95% CI -0.04 to 0.54) and costs of $232,623 by $7,517 (95% CI $103 to 28,161), yielding an incremental cost-effectiveness ratio of $48,269 per QALY gained. The likelihood that CEP would be considered cost-effective at commonly used thresholds of $50-150k/QALY ranged from 45 to 86% ( Figure ). Results were influenced by procedural stroke risk and efficacy of the device. Conclusion: Our results suggest CEP may be considered a cost-effective strategy during TAVR.