Concomitant Left Atrial Appendage Occlusion and Transcatheter Aortic Valve Replacement Among Patients with Atrial Fibrillation

Abstract

Background: Atrial fibrillation (AF) is common in patients undergoing transcatheter aortic valve replacement (TAVR) and is associated with increased risk of bleeding and stroke. While left atrial appendage occlusion (LAAO) is approved as an alternative to anticoagulants for stroke prevention in patients with AF, placement of these devices neither in patients with severe AS, nor at the same time as TAVR, has been extensively studied. Methods: WATCH-TAVR was a multicenter, randomized trial evaluating the safety and effectiveness of concomitant TAVR and LAAO with WATCHMAN in AF patients. Patients were randomized 1:1 to TAVR+LAAO or TAVR+medical therapy. WATCHMAN patients received anticoagulation for 45 days followed by dual antiplatelet therapy until 6 months. Anticoagulation was per treating physician preference for patients randomized to TAVR+medical therapy. The primary non-inferiority endpoint was all-cause mortality, stroke, and major bleeding at 2-years between the two strategies. Results: The study enrolled 349 patients, 177 TAVR+LAAO and 172 TAVR+medical therapy, between December-2017 and November-2020 at 34 US centers. The mean age was 81 years, CHA 2 DS 2 -VASc score was 4.9 and HAS-BLED score was 3.0. At baseline, 85.4% of patients were taking anticoagulation and 71.3% patients were on antiplatelet therapy. The cohorts were well-balanced for baseline characteristics. The incremental LAAO procedure time was 38 minutes; the median contrast volume was 119 mL for combined procedures versus 70 mL with TAVR alone. At 24 months follow-up, 82.5% compared to 50.8% of patients were on any antiplatelet therapy, and 13.9% compared to 66.7% of patients were on any anticoagulation therapy in TAVR+LAAO compared to TAVR+medical therapy group respectively. For the composite primary endpoint, TAVR+.LAAO was non-inferior to TAVR+ medical therapy (22.7 vs 27.3 events/100 patient years for TAVR+LAAO and TAVR+medical therapy respectively; Hazard Ratio 0.86, 95% CI 0.60 -1.22, P noninferiority <0.001). Conclusions: Concomitant WATCHMAN LAAO and TAVR is noninferior to TAVR with medical therapy in severe aortic stenosis patients with AF. The increased complexity and risks of the combined procedure should be considered when concomitant LAAO is viewed as an alternative to medical therapy for patients with AF undergoing TAVR.