Author + information
- Received May 30, 2019
- Revision received October 31, 2019
- Accepted December 9, 2019
- Published online March 30, 2020.
- James V. Freeman, MD, MPH, MSa,b,∗ (, )@jfreemd@Dr_BowTie65,
- Paul Varosy, MDc,
- Matthew J. Price, MDd,
- David Slotwiner, MDe,
- Fred M. Kusumoto, MDf,
- Chidambaram Rammohan, MDg,
- Clifford J. Kavinsky, MD, PhDh,
- Zoltan G. Turi, MDi,
- Joseph Akar, MD, PhDa,b,
- Cristina Koutras, RNj,
- Jeptha P. Curtis, MDa,b and
- Frederick A. Masoudi, MD, MSPHc
- aSection of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut
- bCenter for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut
- cDivision of Cardiology, University of Colorado School of Medicine, Denver, Colorado
- dDivision of Cardiovascular Diseases, Scripps Clinic, La Jolla, California
- eDivision of Cardiology, New York Presbyterian Queens, Weill Cornell Medical College, New York, New York
- fDepartment of Cardiovascular Disease, Mayo Clinic, Jacksonville, Florida
- gDivision of Cardiovascular Medicine, Palo Alto Medical Foundation, El Camino Hospital, Mountain View, California
- hDivision of Cardiovascular Medicine, Rush University Medical Center, Chicago, Illinois
- iCenter for Structural and Congenital Heart Disease, Hackensack University Medical Center, Hackensack, New Jersey
- jAmerican College of Cardiology Foundation, Washington, DC
- ↵∗Address for correspondence:
Dr. James V. Freeman, Section of Cardiovascular Medicine, Yale University School of Medicine, P.O. Box 208017, New Haven, Connecticut 06520.
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.
This study was funded by the American College of Cardiology National Cardiovascular Data Registry (NCDR) and National Heart, Lung, and Blood Institute grants R56HL142765 and R01HL142765. Dr. Freeman has received salary support from the American College of Cardiology NCDR and the National Heart, Lung, and Blood Institute; and has received consulting/Advisory Board fees (modest) from Boston Scientific, Medtronic, Janssen Pharmaceuticals, and Biosense Webster. Dr. Price has received consulting/Advisory Board fees and honoraria from Boston Scientific, Chiesi USA, Medtronic, Abbott Vascular, W.L. Gore Medical, AstraZeneca, and Conformal Medical; and has received research grants (to institution) from Daiichi-Sankyo. Dr. Rammohan has received consulting fees from Medtronic and Abbott Vascular. Dr. Turi has received lecturing honoraria from Abbott Vascular; and has served on the Data Safety Monitoring Board for Coherex for the Wavecrest 2 Trial. Dr. Curtis has an institutional contract with the American College of Cardiology for his role as Senior Scientific Advisor of the NCDR; has received salary support from the American College of Cardiology and Centers for Medicaid & Medicare Services; and has equity in Medtronic. Dr. Masoudi has an institutional contract with the American College of Cardiology for his role as Chief Scientific Advisor of the NCDR. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received May 30, 2019.
- Revision received October 31, 2019.
- Accepted December 9, 2019.
- 2020 American College of Cardiology Foundation
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.