The NCDR Left Atrial Appendage Occlusion Registry

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.

Keywords: atrial fibrillation; bleeding; hospital volume; left atrial appendage occlusion; registry; stroke.

Figure 1.

Procedure Volume (A), Implanting Physicians, and Implanting Hospitals (B) in the NCDR LAAO Registry. Between January 1, 2016 and December 31, 2018, data were collected for 38,158 left atrial appendage implant procedures performed by 1,318 physicians in 495 hospitals in the United States. NCDR= National Cardiovascular Data Registry, LAAO= Left Atrial Appendage Occlusion

Figure 1.

Procedure Volume (A), Implanting Physicians, and Implanting Hospitals (B) in the NCDR LAAO Registry. Between January 1, 2016 and December 31, 2018, data were collected for 38,158 left atrial appendage implant procedures performed by 1,318 physicians in 495 hospitals in the United States. NCDR= National Cardiovascular Data Registry, LAAO= Left Atrial Appendage Occlusion

Figure 2.

Implant success rates in the pivotal trials and registries compared with the LAAO Registry. Among procedures in the NCDR LAAO Registry in the first three years in which a device was deployed, 98.3% were successfully implanted, which was higher than in the pivotal trials and consistent with the more recent EWOLUTION Registry. LAAO= Left Atrial Appendage Occlusion.

Figure 3.

Distribution of CHA₂DS₂-VASC (A) and HAS-BLED (B) Scores Among Patients Enrolled in the LAAO Registry between January 1, 2016 to December 31, 2018. Patients had a high risk of stroke and thromboembolism with a mean CHA₂DS₂-VASC score of 4.6±1.5 and a high risk of bleeding events with a mean HAS-BLED score of 3 ±1.1. LAAO= Left Atrial Appendage Occlusion.

Figure 3.

Distribution of CHA₂DS₂-VASC (A) and HAS-BLED (B) Scores Among Patients Enrolled in the LAAO Registry between January 1, 2016 to December 31, 2018. Patients had a high risk of stroke and thromboembolism with a mean CHA₂DS₂-VASC score of 4.6±1.5 and a high risk of bleeding events with a mean HAS-BLED score of 3 ±1.1. LAAO= Left Atrial Appendage Occlusion.

Figure 4.

Distribution of Hospital Annual Procedure Volume among 495 Participating Hospitals in the LAAO Registry between January 1, 2016 to December 31, 2018. The figure shows the number of hospitals in each annual volume category. The median number of LAAO procedures performed annually among enrolling hospitals was 30 (interquartile range [IQR] 26) with most hospitals performing <40 procedures annually, although there was considerable variation in annual volume. LAAO= Left Atrial Appendage Occlusion.

Figure 5.

Distribution of Physician Annual Procedure Volume among 1147 Physicians in the LAAO Registry between January 1, 2016 to December 31, 2018. The figure shows the number of physicians in each annual volume category. Among implanting physicians, the median number of LAAO procedures performed annually was 12 (IQR 12) with most physicians performing <20 procedures annually, although there was considerable variation. LAAO= Left Atrial Appendage Occlusion.

Central Illustration.. Procedure Volume, Implanting Physicians, Implanting Hospitals, and Major In-hospital Adverse Events.

Between January 1, 2016 and December 31, 2018 in the NCDR LAAO Registry, data were collected for 38,158 left atrial appendage implant procedures performed by 1,318 physicians in 495 hospitals in the United States. NCDR= National Cardiovascular Data Registry, LAAO= Left Atrial Appendage Occlusion