Left atrial appendage occlusion using the amplatzer amulet device in high-risk patients with atrial fibrillation undergoing transcatheter aortic valve intervention: a pilot study

Background Patients with atrial fibrillation (AF) undergoing transcatheter aortic valve intervention (TAVI) are at increased risk of bleeding and neurologic events. Left atrial appendage occlusion (LAAO) may be a therapeutic option to standard medical therapy (SMT) for the reduction of the risk of bleeding and the prevention of neurologic events. Purpose This investigator-initiated, randomized, multicenter, open-label pilot study assessed LAAO and early cessation of oral anticoagulation as compared to SMT in patients with AF undergoing TAVI. Methods Patients were randomly assigned to LAAO (TAVI+LAAO) or standard medical therapy (TAVI+SMT). The primary end point was a composite of ischemic and hemorrhagic neurologic events, peripheral embolism, life-threatening/disabling and major bleeding, or cardiovascular mortality at 1 year. A sensitivity analysis was performed in the per-protocol population. Results A total of 81 high-risk patients (age: 82.8±5.3 years, STS-score: 9.04±5.42%) were enrolled between May 2016 and May 2018 at 3 sites in Switzerland. At discharge, 92% in TAVI+LAAO were on antiplatelet therapy only and 87% in TAVI+SMT on OAC. Follow-up was available for all patients. Rates of the primary end point did not differ between groups (TAVI+LAAO: 33%; TAVI+SMT: 37%; adjusted OR 0.87; 95%CI: 0.32-2.29, P=0.77). Bleeding was numerically lower in TAVI+LAAO (13%) as compared to TAVI+SMT (17%), with absent non-procedural bleeding in TAVI+LAAO and 5 gastrointestinal bleedings in TAVI+SMT, but neurologic events were numerically higher in TAVI+LAAO (10% vs. 2.4% in TAVI+SMT). LAAO was not attempted because of complications prior to LAAO in 3 patients, and the LAA occluder was not deployed due to technical challenges in 1 patient, resulting in a per-protocol population of 36 patients in the TAVI+LAAO group and 41 patients in the TAVI+SMT group. In the per-protocol analysis, rates of the primary end point were comparable between groups (adjusted OR, 0.55; 95%CI: 0.18-1.56, P=0.27) with numerically higher neurologic (5.6% vs. 2.4%), but lower bleeding events (8.3% vs. 17%) in the TAVI+LAAO group as compared to the TAVI+SMT group. Conclusion 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 showed similar rates of the primary end point as compared to a single TAVI procedure.