Concomitant LAAO an alternative to medical therapy for AF patients undergoing TAVR: WATCH-TAVR trial

The researchers advise considering the increased complexity and risks of the combined procedure when concomitant LAAO is viewed as an alternative for medical therapy for patients with AF undergoing TAVR. The findings from the WATCH-TAVR study were presented at TCT 2023 and simultaneously published in Circulation.

"Concomitant LAAO with the Watchman 2.5 device (Boston Scientific) and TAVR was noninferior to TAVR plus chronic oral anticoagulation for the primary endpoint of stroke, all-cause mortality, and major bleeding at 2 years among patients with severe symptomatic aortic stenosis and AF," the researchers reported.

At 2-year follow-up, the primary noninferiority endpoint occurred in 33.9% of patients who received LAAO a TAVR compared with 37.2% who received TAVR plus medical therapy (HR = 0.86;).

In patients undergoing TAVR, atrial fibrillation is common and is associated with an increased risk of stroke and bleeding. Left atrial appendage occlusion is being approved as an alternative to anticoagulants for stroke prevention in AF patients but placement of these devices neither in patients with severe AS nor at the same time as TAVR, has been extensively studied.

To fill this knowledge gap, Samir R. Kapadia, Cleveland Clinic, Cleveland, OH, and colleagues evaluated the effectiveness and safety of concomitant TAVR and LAAO with WATCHMAN in AF patients by conducting WATCH-TAVR, a multicenter, randomized trial.

349 patients were randomized in the ratio of 1:1 to TAVR+LAAO (n=177) or TAVR+medical therapy (n=172). WATCHMAN patients received anticoagulation for 45 days followed by dual antiplatelet therapy (DAPT) until 6 months. For patients randomized to medical therapy, anticoagulation was per the treating physician's preference. The primary non-inferiority endpoint was stroke, all-cause mortality, and major bleeding at 2 years between the two strategies.

The researchers reported the following findings:

· CHA2DS2-VASc score was 4.9 and HAS-BLED score was 3.0.

· At baseline, 85.4% of patients were taking anticoagulation and 71.3% of 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 of 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).

"The risks of the combined procedures and increased complexity should be considered when concomitant LAAO is viewed as an alternative to medical therapy for patients with AF undergoing TAVR," the researchers wrote.

The study did not account for differences between the groups beyond 2 years. Also, the study was limited to using only the Watchman 2.5 device.

Reference:

Kapadia SR, et al. Circulation. 2023;doi:10.1161/CIRCULATIONAHA.123.067312.