Left Atrial Appendage Occlusion Versus Direct Oral Anticoagulation in Atrial Fibrillation Patients at Very High Risk of Stroke: A Budget Impact Analysis in Italy

Background: Left atrial appendage occlusion (LAAO) requires a significant upfront investment, which is in contrast with the more gradual, long-term costs of direct oral anticoagulants (DOACs). Objective: We performed a budget impact analysis exploring the financial impact of increasing the number of LAAO procedures in a high-stroke-risk population over a 10-year time horizon from the perspective of the healthcare providers under the Italian National Healthcare Service. Methods: Two alternative scenarios simulating an increased uptake of the LAAO therapy were compared to the estimated volume of LAAO procedures performed (baseline scenario: 1341 procedures): (1) Alternative Scenario I (3314 procedures) based on the level of penetration observed in the Italian region performing the highest rate of LAAO procedures; (2) Alternative Scenario II (7672 procedures): LAAO therapy uptake set to attain 5% of the estimated target population. Clinical data were extracted from a propensity-matched, multicenter cohort of 554 AF patients at a very high thromboembolic risk profile (CHA2DS2-VASc score ≥ 5) treated with LAAO or DOACs. Results: Cumulative cost savings in Alternative Scenario I were around €4.9 million compared to the baseline. When comparing Scenario II to the baseline scenario, savings added up to €15.8 million over 10 years. The break-even point occurred between the seventh and eighth years. Cost savings were observed even in the instance that all DOAC prices would decrease as generics became available. Conclusions: The widespread use of LAAO therapies in a population of AF patients at very high stroke risk may yield substantial long-term benefits, as the initial investment in the LAAO procedure and device would be counterbalanced within 8 years.