Building upon the success of the Watchman device, Boston Scientific (Marlborough, MA) conducted a single-arm 400-patient trial of the next generation Watchman FLX (pronounced “flex”) device at 29 US sites. Subjects underwent left atrial appendage occlusion (LAAO) with the Watchman FLX device followed by an antithrombotic regimen of DOAC + aspirin for 45 days, then clopidogrel + aspirin through 6 months, and final aspirin indefinitely. The investigators reported a 100% rate of effective LAAO by transesophageal echocardiography (TEE) at 1 year. The primary endpoint of all-cause mortality, ischemic stroke, systemic embolism, or major device/procedure-related complications occurred in only 2 patients (0.5%). Results were reported at the May 2020 meeting of the Heart Rhythm Society (HRS). The Watchman FLX device received CE Mark approval in Europe in March 2019 and FDA approval in the US in August 2020.
All Editors: Andrew M. Goldsweig, MD, MSC, RPVI, FSCAI
Including recently published studies, coverage of late-breaking science, updates from clinical trials and registries, and complex case presentations.