Mechanical left appendage occlusion (LAAO) with Watchman has been proven as effective alternative to warfarin in clinical trials. We aim to investigate the long-term efficacy and safety of LAAO with Watchman compared to direct oral anticoagulation (DOAC).
We identified 99 atrial fibrillation patients with a history of ischemic stroke from January 2018 to March 2020 who were not suitable for DOAC, including non-traumatic intracranial hemorrhage, systemic bleeding, or had a recurrent stroke while compliance with DOAC. Variables of demographics, comorbidities - hypertension, hyperlipidemia, diabetes, smoking status, CHADS2-VASC, and HAS-BLED score were collected.
Our study evaluated if LAAO with Watchman is non-inferior to the current standard recommendation of DOAC in patients with AF up to 5 years following LAAO with Watchman
A total of 99 patients were included, 57 male (58%). The mean CHADS2-VASC score 4.8±1.3. The mean HAS-BLED score was 3.2±0.8. All patients received 45 days of either dual antiplatelet therapy (DAPT) or DOAC after the procedure, then switched to antiplatelet monotherapy. There were no procedure-related complications in this study cohort.
After a median follow-up of 61±6 months post-Watchman, 3 patients who received a Watchman device demonstrated a similarly low rate of recurrent ischemic stroke (3.03%), compared to 3.0% incidence of stroke in AF patients receiving standard DOAC (Circulation 2022). The stroke mechanism in three patients with recurrent stroke was determined as intracranial artery stenosis and cardiogenic in the setting of unremarkable vascular study
Device-associated thrombus without recurrent ischemic stroke was detected in only one patient. No residual leaks were detected in patients after post-LAAO with the Watchman device using a transesophageal echocardiogram.
Watchman LAAO is non-inferior to DOAC for secondary stroke prevention in patients with AF after a median follow-up of 61months. In this real-world study cohort, LAAO with Watchman demonstrated an excellent safety profile with no post-procedure complications.