Left atrial appendage occlusion using the Watchman device in a national registry of 38,158 procedures demonstrated a major in-hospital adverse event rate of 2.16%.
Observational (n=38,158)
Yes
What are the patient characteristics and in-hospital safety outcomes of left atrial appendage occlusion in real-world practice?
Real-world data from the NCDR LAAO Registry demonstrates that LAAO procedures have a low rate of major in-hospital adverse events (2.16%) despite being performed in an older, higher-risk population compared to pivotal trials.
BACKGROUND: Left atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited. OBJECTIVES: The purpose of this study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years. METHODS: The authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates. RESULTS: A total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA2DS2-VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, 65 to 74 years of age, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 18 to 44) and for physicians was 12 (interquartile range: 8 to 20). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with 38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials.
“Based on these data, it seems like we're doing the right thing. The rate of ischemic stroke was low and supports the clinical effectiveness of transcatheter LAAO as it is currently applied in the U.S.”
Freeman et al. (2020) conducted an observational in Atrial fibrillation (n=38,158). Left atrial appendage occlusion (Watchman) was evaluated on Major in-hospital adverse events. Left atrial appendage occlusion using the Watchman device in a national registry of 38,158 procedures demonstrated a major in-hospital adverse event rate of 2.16%.