The NCDR Left Atrial Appendage Occlusion Registry
Key result
Watchman LAAO demonstrates a 2.16% rate of major in-hospital adverse events.
- n=38,158
Why the study?
LAAO has been evaluated in two randomized trials, but post-approval clinical data are limited.
What are the patient characteristics and in-hospital safety outcomes of left atrial appendage occlusion in real-world practice?
Key Points
- This study aims to describe the NCDR LAAO Registry and assess in-hospital adverse event rates for Watchman procedures.
- Described the LAAO Registry structure and governance
- Analyzed data from 38,158 procedures across 495 hospitals
- Characterized patient demographics and in-hospital outcomes
- 2.16% of patients experienced major in-hospital adverse events
- Pericardial effusion requiring intervention occurred in 1.39%
- Major bleeding reported in 1.25% of cases, with rare instances of stroke (0.17%) and death (0.19%)
Study Design
Type
Observational (n=38,158)
Multicenter
Yes
Structured PICO
What are the patient characteristics and in-hospital safety outcomes of left atrial appendage occlusion in real-world practice?
P
Population
38,158 patients undergoing left atrial appendage occlusion (LAAO) procedures to prevent stroke in atrial fibrillation, mean age 76.1 ± 8.1 years, mean CHA2DS2-VASc 4.6 ± 1.5, mean HAS-BLED 3.0 ± 1.1, across 495 hospitals in the United States.
I
Intervention
Left atrial appendage occlusion (LAAO) using the Watchman device
O
Outcome
In-hospital adverse event ratessafety
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.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“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.”
“You can try to paint the picture for patients, so that they have realistic expectations for left atrial appendage occlusion and try to kind of get across what those risks and benefits truly are.... It's not likely to lengthen their life necessarily.”
AGAndrew GoldsweigCardiologist, University of Massachusetts-Baystate
“The best news that I see in this is that the LAAO registry is linked to Medicare data, so that we can continue to get longer-term follow-up on more contemporary patients.”
Implication
Reassures on procedural safety in contemporary practice; extends RCT evidence to older higher-risk patients while leaving open long-term effectiveness.
Abstract
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 <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare. CONCLUSIONS: The LAAO Registry has enrolled >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.
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Cite This Study
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%.