Real-World Cost-Effectiveness of Pulmonary Vein Isolation for Atrial Fibrillation: A Target Trial Approach.

Randomized controlled trials of pulmonary vein isolation (PVI) for treating atrial fibrillation (AF) have proven the procedure's efficacy. Studies assessing its empirical cost-effectiveness outside randomized trial settings are lacking. We aimed to evaluate the effectiveness and cost-effectiveness of PVI versus medical therapy for AF. We followed a target trial approach using the Swiss-AF cohort, a prospective observational cohort study that enrolled patients with AF between 2014 and 2017. Resource utilization and cost information were collected through claims data. Quality of life was measured with EQ-5D-3L utilities. We estimated incremental cost-effectiveness ratios (ICERs) from the perspective of the Swiss statutory health insurance system. Patients undergoing PVI compared with medical therapy had a 5-year overall survival advantage with a hazard ratio of 0.75 (95% CI 0.46-1.21; P =.69) and a 19.8% SD improvement in quality of life (95% CI 15.5-22.9; P <.001), at an incremental cost of 29 604 Swiss francs (CHF) (95% CI 16 354-42 855; P <.001). The estimated ICER was CHF 158 612 per quality-adjusted life-year (QALY) gained within a 5-year time horizon. Assuming similar health effects and costs over 5 additional years changed the ICER to CHF 82 195 per QALY gained. Results were robust to the sensitivity analyses performed. Our results show that PVI might be a cost-effective intervention within the Swiss healthcare context in a 10-year time horizon, but unlikely to be so at 5 years, if a willingness-to-pay threshold of CHF 100 000 per QALY gained is assumed. Given data availability, we find target trial designs are a valuable tool for assessing the cost-effectiveness of healthcare interventions outside of randomized controlled trial settings. • What is the real-world cost-effectiveness of pulmonary vein isolation (PVI) compared with standard medical therapy for patients with atrial fibrillation? • In this economic evaluation designed with a target trial approach including 2379 patients with real-world clinical, quality of life, and costing data, we estimate the incremental cost-effectiveness ratio of PVI compared with standard medical therapy to be 158 612 Swiss francs per quality-adjusted life-year gained (1 US dollar ∼ 0.93 Swiss francs) at 5 years and 82 195 per quality-adjusted life-year at 10 years. • In our target trial emulation-based cost-effectiveness assessment, PVI for the management of atrial fibrillation might be cost-effective over a 10-year period. [ABSTRACT FROM AUTHOR]