SAN FRANCISCO — Left atrial appendage occlusion (LAAO) at the time of transcatheter aortic valve replacement (TAVR) using the WATCHMAN 2.5 device (Boston Scientific) is feasible and non-inferior to TAVR followed by medical therapy on the composite endpoint of all-cause mortality, stroke, and major bleeding in patients with both atrial fibrillation (AF) and severe aortic stenosis.
However, arterial and venous thromboembolism occurred more often in patients who had the combined procedure compared with TAVR and medical therapy.
Based on past trials, AF typically is present in about 33%–40% of patients undergoing TAVR.
"The duration of WATCHMAN was only 45 minutes added to the procedure," Samir Kapadia, MD, of the Cleveland Clinic, told attendees here at Transcatheter Cardiovascular Therapeutics 2023. The results of the WATCH-TAVR study were simultaneously published online in the journal Circulation.
Compared with TAVR plus medical therapy, hospital length of stay and rate of acute kidney injury were no different. Using WATCHMAN with TAVR, pericardial effusion occurred in four patients and required only draining. Kapadia said the combination procedure required 40 mL more contrast volume.
This non-inferiority study was investigator initiated, prospective, and involved 34 centers in North America. It enrolled 349 patients (TAVR + LAAO, n = 177; TAVR + medical therapy, n = 172) undergoing transfemoral TAVR and evaluated them for the primary endpoint of the first occurrence of all-cause mortality, any stroke, or life-threatening or major bleeding events within 24 months.
