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.