Left atrial appendage occlusion combined with TAVI resulted in similar rates of the primary composite endpoint compared to TAVI with standard medical therapy (33% vs 37%; OR 0.87; P=0.77).
RCT (n=81)
Open-label
randomly assigned
Yes
Does left atrial appendage occlusion combined with TAVI reduce the composite of cerebrovascular events, peripheral embolism, major bleeding, or cardiovascular mortality in high-risk patients with AF undergoing TAVI?
In a pilot study of high-risk patients with AF undergoing TAVI, combining LAAO with TAVI resulted in similar 1-year rates of a composite clinical endpoint compared to TAVI with standard medical therapy.
Odds Ratio: 0.87 (95% CI 0.32–2.29)
Absolute Event Rate: 33% vs 37%
p-value: p=0.77
Background 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. Methods 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. Results 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. Conclusions 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).
Jakob et al. (2025) conducted an RCT in Severe aortic stenosis and atrial fibrillation undergoing TAVI (n=81). Left atrial appendage occlusion (LAAO) vs. Standard medical therapy (SMT) was evaluated on Composite of cerebrovascular events, peripheral embolism, life-threatening/disabling/major bleeding, or cardiovascular mortality at 1 year (adjusted OR 0.87, 95% CI 0.32-2.29, p=0.77). Left atrial appendage occlusion combined with TAVI resulted in similar rates of the primary composite endpoint compared to TAVI with standard medical therapy (33% vs 37%; OR 0.87; P=0.77).