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NCDR Left Atrial Appendage Occlusion Registry
Study Questions:
What are patient, hospital, and physician characteristics and in-hospital outcomes for Watchman procedures performed in the United States in its first 3 years?
Methods:
The authors describe the National Cardiovascular Data Registry (NCDR) left atrial appendage occlusion (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 Watchman 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, 4-56) and for physicians was 12 (interquartile range, 0-14). 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.
Perspective:
The LAAO registry allows an in-depth evaluation of patient, provider, and hospital characteristics for the Watchman procedure/implant over its first 3 years. Patient characteristics are notable for older age and more women in the registry compared to those enrolled in the randomized controlled trials. Median individual hospitals implanted approximately 30 devices a year and each physician approximately 12 a year. Success rates and outcomes were better in the registry patients compared to randomized controlled trials. Patients were higher risk for both bleeding and thromboembolism compared to registry data. Whether further analysis of registry data can help refine selection criteria for Watchman versus continued oral anticoagulation remains to be seen.
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Pericardial Disease, Prevention, Pulmonary Hypertension and Venous Thromboembolism, Vascular Medicine, Anticoagulation Management and Venothromboembolism, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure, Hypertension
Keywords: Anticoagulants, Arrhythmias, Cardiac, Atrial Appendage, Geriatrics, Heart Failure, Hemorrhage, Hypertension, Ischemic Attack, Transient, National Cardiovascular Data Registries, Pericardial Effusion, Stroke, Vascular Diseases, Venous Thromboembolism
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