April 24, 2026Open Access
View Full PaperThe NCDR Left Atrial Appendage Occlusion Registry
Key Result
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%.
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.
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 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.
Expert Takes3 quotes
1/3
“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.”
Matthew J. Price, Director, cardiac catheterization laboratory, Scripps ClinicScripps Clinicauto_pipelineView source