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Updated: Dec 25, 2025
Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
The NCDR Left Atrial Appendage Occlusion Registry
James V Freeman1, Paul Varosy2, Matthew J Price3
1Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut.
Insights
Left atrial appendage occlusion (LAAO) using the Watchman device is effective for stroke prevention in atrial fibrillation patients. Post-market data show low adverse event rates, even in older patients with comorbidities.
Area of Science:
- Cardiology
- Medical Devices
- Public Health
Background:
- Limited post-approval clinical data exist for Left Atrial Appendage Occlusion (LAAO) device use in preventing stroke in atrial fibrillation patients.
- Existing data primarily stem from two randomized trials, necessitating real-world evidence.
Purpose of the Study:
- To describe the National Cardiovascular Data Registry (NCDR) LAAO Registry structure and governance.
- To present patient, hospital, and physician characteristics for Watchman procedures.
- To report in-hospital adverse event rates for LAAO procedures in the United States over a three-year period.
Main Methods:
- Analysis of data from the NCDR LAAO Registry, encompassing procedures performed between January 2016 and December 2018.
- Characterization of patient demographics, comorbidities (CHA2DS2-VASc and HAS-BLED scores), and procedural details.
- Adjudication of outcomes and assessment of data quality for collected information.
Main Results:
- 38,158 LAAO procedures were included, performed by 1,318 physicians across 495 hospitals.
- Patients were older (mean age 76.1 years) with high comorbidity scores (CHA2DS2-VASc 4.6, HAS-BLED 3.0).
- Major in-hospital adverse events occurred in 2.16% of patients, with pericardial effusion (1.39%) and bleeding (1.25%) being most common; stroke (0.17%) and death (0.19%) were rare.
Conclusions:
- The NCDR LAAO Registry successfully enrolled over 38,000 patients.
- Patients undergoing LAAO were older and had more comorbidities than those in pivotal trials.
- In-hospital adverse event rates were lower than previously reported in clinical trials, indicating favorable real-world outcomes.
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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