Transcatheter left atrial appendage occlusion (LAAO) with a WATCHMAN device may be associated with a low rate of stroke at one year among older patients with atrial fibrillation (AFib) at high risk for stroke or bleeding, according to a study presented during a Featured Clinical Research session May 15 during ACC.21.

Matthew J. Price, MD, FACC, et al., used data from ACC's LAAO Registry to assess the rates of thromboembolic and bleeding events one year following transcatheter LAAO in 36,681 patients who received the WATCHMAN device between 2016 and 2018. The study's primary endpoint was rate of ischemic stroke. Secondary endpoints included mortality, systemic embolism and major bleeding.

Overall, patients in the study were older and at higher risk than those who participated in clinical trials for the WATCHMAN device. The average age of patients in the study was 76 years, about one-quarter had a prior stroke and nearly 70% had a history of clinically relevant bleeding.

After one year, 1.53% of patients experienced an ischemic stroke, 8.52% died, less than 0.7% experienced systemic embolism, and 6.2% experienced major bleeding. The stroke rate was 77% lower than expected based on patients' CHA2DS2-VASc scores.

According to the researchers, the findings support clinical effectiveness of transcatheter LAAO and demonstrate a low rate of thromboembolic events after one year. They note that risks of bleeding in the early post-discharge period and of death unrelated to thromboembolism should be incorporated into shared decision-making for AFib patients who are not candidates for long-term oral anticoagulants.

Price et al., note that future research should assess LAAO in broader patient populations and on outcomes from new devices or techniques for performing the procedure. In addition, future studies are planned to look at clinical efficacy at three and four years following the procedure.

"I was actually a bit surprised by the relatively low event rates because the patients are substantially higher risk than those studied in clinical trials," Price said. "However, all-cause mortality, as well as bleeding in the weeks following the procedure, were not infrequent – consistent with the co-morbidities of this patient population. This underscores the need to individualize one's approach to stroke prevention so that patients reap the clinical benefit of stroke reduction."

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Interventions and Imaging

Keywords: ACC Annual Scientific Session, ACC21, LAAO Registry, National Cardiovascular Data Registries, Atrial Fibrillation, Atrial Appendage, Stroke, Diagnostic Imaging, Cardiac Surgical Procedures

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