Decision-analytic modeling of concomittant left atrial appendage closure versus lifelong anticoagulation after atrial fibrillation ablation: cost-effectiveness and lifetime outcomes

Background Lifetime oral anticoagulation (OAC) is recommended for patients at high risk of stroke following atrial fibrillation (AF) ablation irrespective of rhythm outcomes. Left atrial appendage occlusion (LAAC) is a mechanical alternative to anticoagulation, and its combination with AF ablation is supported by new evidence. The aim of our analysis was to evaluate the cost-effectiveness of LAAC performed in a single session with AF ablation compared to new oral anticoagulants (NOACs) in patients at high risk of stroke. Methods and results We built a Markov model simulating the entire lifetime of patients with potential thromboembolic and bleeding events, mortality, costs (from the perspective of the Hungarian healthcare financing system), and quality of life utilities. The thromboembolic and bleeding outcomes associated with LAAC and NOAC treatment were derived from the results of the OPTION randomized trial. Other inputs (procedural complications, mortality data) were obtained from propensity score-matched studies, large registries, epidemiological studies and data from the Hungarian Central Statistical Office. Costs were derived from hospital records and national diagnosis related group values. The model was run on a population of 10,000 patients with an average CHA2DS2-VASc score of 3.5±1.3. We analyzed two scenarios, with a baseline age of 70 and 60 years, and performed a sensitivity analysis by randomly varying the inputs within 95% confidence intervals (CI). When performed at age 70, LAAC became cost-effective compared to NOACs by year 9 (EUR 13,600/quality-adjusted life year [QALY]) mainly due to accumulation of drug costs for NOACs. Over their lifetime, patients gained 0.35 (95% CI: 0.24–0.57) more QALYs with LAAC than with NOAC therapy (+4%). The lifetime risk was lower on the LAAC arm for all individual outcomes of ischemic stroke (RR=0.78), major bleeding (RR=0.55), and clinically relevant non-major bleeding (RR=0.43). In the sensitivity analysis, LAAC was cost-effective compared to NOACs in 97.4% of simulations. In the 60-year-old cohort, LAAC became cost-effective earlier, providing 0.57 (95% CI: 0.48–0.91) more QALYs and saving EUR 2,632 in additional costs per patient. Conclusion LAAC combined with AF ablation is a cost-effective alternative to lifelong NOAC therapy in patients at high risk of stroke, and provides more QALYs on avarage.