Cost-Effectiveness of Pulmonary Vein Isolation with Epicardial Left Atrial Appendage Ligation for the Treatment of Non-Paroxysmal Atrial Fibrillation

Introduction: Electrical isolation of the left atrial appendage (LAA) using percutaneous epicardial ligation may improve catheter ablation outcomes for non-paroxysmal atrial fibrillation (AF) patients. Little is known regarding the cost effectiveness of this procedure. Hypothesis: We hypothesized that cost-effectiveness between pulmonary vein isolation (PVI) + LAA epicardial ligation using a percutaneous LARIAT ® Suture Delivery Device would be cost effective (CE) compared to PVI alone over 5 years. Methods: A Markov model simulated outcomes for a population with annual stroke risk of 4.6% (CHA 2 DS 2 -VASc score 3). Model inputs for procedure efficacy, stroke and bleed events, health utility, and event costs were estimated from literature. Procedure costs from Medicare rates were used. The model had a 5-year time-horizon and US payer perspective. Univariate and probabilistic sensitivity analyses (PSA) were performed. Outcomes were health care costs and quality-adjusted life-years (QALYs). In the base case, PVI + LAA ligation efficacy from published studies was 67% after 1-year, with an estimated 25% oral anticoagulant (OAC) utilization in PVI + LAA ligation patients in normal sinus rhythm 13-60 months after the index procedure. Cost effectiveness thresholds were evaluated with alternative PVI + LAA ligation efficacy and OAC utilization rates, including 1-year PVI + LAA ligation efficacies of 67%, 70%, 75%, and 80% and OAC utilization of 20-60%. Results: In the base case, PVI + LAA ligation had a mean 5-year cost of $72,865 with 3.25 QALYs and PVI alone had mean cost of $69,936 with 3.19 QALYs. The incremental cost-effectiveness ratio was $46,716; PVI + LAA ligation was CE at $50,000 per QALY gained. In PSA, 64% and 82% of simulations were CE at $50,000 and $100,000 per QALY gained, respectively. In various scenarios, procedure efficacy of 75% combined with OAC utilization of 50% or below yielded CE at $50,000 per QALY gained. Reduction of OAC utilization to 30% yielded CE at $50,000 per QALY gained, regardless of efficacy. Conclusions: In the base case, PVI + LAA ligation was CE at $50,000 per QALY gained when compared to PVI alone. The CE threshold for efficacy was 75% and OAC utilization was 30%. Cost savings were driven by reductions in OAC use and increased efficacy.