Left Atrial Appendage Occlusion Using the Amplatzer Amulet Device in High-Risk Patients With Atrial Fibrillation...

Patients with severe aortic stenosis and atrial fibrillation (AF) undergoing transcatheter aortic valve intervention (TAVI) are at increased risk of bleeding and cerebrovascular events. This investigator-initiated, randomized, multicenter, open-label pilot study assessed left atrial appendage occlusion (LAAO) in patients with AF undergoing TAVI.

Patients were randomly assigned to LAAO (TAVI + LAAO) or standard medical therapy (SMT) (TAVI + SMT). The primary endpoint was a composite of cerebrovascular events, peripheral embolism, life-threatening/disabling/major bleeding, or cardiovascular mortality at 1 year. A sensitivity analysis was performed in the per-protocol population.

Eighty-one patients (Society of Thoracic Surgeons score: 9.0% ± 5.4%) were enrolled. The primary endpoint occurred in 13 patients (33%) in the TAVI + LAAO group and in 15 patients (37%) in the TAVI + SMT group (adjusted odds ratio [OR], 0.87; 95% CI: 0.32-2.29, p = 0.77). Bleeding rates were comparable between TAVI + LAAO (13%) and TAVI + SMT (17%), with absent nonprocedural bleeding in the TAVI + LAAO group and 5 gastrointestinal bleedings in TAVI + SMT, and cerebrovascular events did not significantly differ between groups (10% in TAVI + LAAO vs. 2.4% in TAVI + SMT). In the per-protocol analysis, occurrence of the primary endpoint was comparable between groups (adjusted OR, 0.55; 95% CI: 0.18-1.56, p = 0.27) with cerebrovascular events in 5.6% and 2.4%, and bleeding events in 8.3% and 17% for TAVI + LAAO and TAVI + SMT, respectively.

This pilot study suggests that among high-risk patients with AF undergoing TAVI, a strategy of a combined procedure with LAAO and early cessation of oral anticoagulation overall showed similar rates of the primary end point as compared to a single TAVI procedure (NCT03088098).