Cost-Effectiveness of Atrioventricular Synchronous Leadless Pacing in Patients With Atrioventricular Block: Results and Implications From an Exploratory Analysis for Japan.

Background: Atrioventricular (AV) synchronous pacing with a transcatheter pacing system (TC-PM) is an alternative to transvenous pacemakers (TV-PM) in patients with AV block. In this study we assessed the potential cost-effectiveness of TC-PM in Japan and methodological implications for future global cost-effectiveness analyses. Methods and Results: A decision-analytic Markov model captured strategy-specific complication rates, device replacements, and health-related quality of life. Parameter inputs were derived from systematic literature search, clinical studies, and claims data. The discounted lifetime incremental cost-effectiveness ratio (ICER, in JPY per quality-adjusted life-year (QALY) gained) was evaluated against a 5 million JPY per QALY willingness-to-pay threshold. Extensive scenario and sensitivity analyses were conducted. TC-PM was associated with lower complication rates (3.8% vs. 9.8% at 36 months, hazard ratio 0.39; P<0.001) and a lifetime cost increase of JPY632,849 (JPY2,268,945 vs. JPY1,636,096). TC-PM concurrently added 0.24 (3.33 vs. 3.09) QALYs, rendering TC-PM cost-effective in the base case (ICER JPY2,640,519 per QALY gained), but not all scenarios. Long-term quality-of-life assumptions, as also evidenced by a recent Japanese government study, are an important driver of cost-effectiveness. Conclusions: AV-synchronous pacing with a TC-PM is associated with lower complication rates and some improvement in projected quality-adjusted survival that can render it a cost-effective intervention in the Japanese healthcare system as long as some of the observed short-term quality-of-life benefit is maintained.