Usama A Daimee1, Yongfei Wang2, Frederick A Masoudi3, Paul D Varosy3, Daniel J Friedman2,4, Chengan Du2, Cristina Koutras5, Vivek Y Reddy6, Jacqueline Saw7, Matthew J Price8, Fred M Kusumoto9, Jeptha P Curtis2,4, James V Freeman2,4. 1. Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, MD (U.A.D.). 2. Center for Outcomes Research and Evaluation Yale New Haven Health Services Corporation, New Haven, CT (Y.W., D.J.F., C.D., J.P.C., J.V.F.). 3. Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora (F.A.M., P.D.V.). 4. Section of Cardiovascular Medicine (D.J.F., J.P.C., J.V.F.), Yale University School of Medicine, New Haven, CT. 5. American College of Cardiology Foundation, Washington, DC (C.K.). 6. Division of Cardiology, Icahn School of Medicine at Mount Sinai, New York, NY (V.Y.R.). 7. Division of Cardiology, Vancouver General Hospital, The University of British Columbia (J.S.). 8. Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, CA (M.J.P.). 9. Department of Cardiovascular Disease, Mayo Clinic, Jacksonville, FL (F.M.K.).
Abstract
BACKGROUND: The Food and Drug Administration approved left atrial appendage occlusion with the Watchman device for patients who are at increased stroke risk and are suitable for oral anticoagulation but who have an appropriate reason to seek a nondrug alternative. These broad criteria raise the question of their interpretation in clinical practice. There is a lack of studies comprehensively evaluating the indications for Watchman implantation among a large series of patients from contemporary, real-world practice in the United States. METHODS: We used the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry to identify Watchman procedures performed between 2016 and 2018. We assessed procedural indications for Watchman implantation in the United States and evaluated the association between procedural indications and in-hospital adverse events. RESULTS: A total of 38 314 procedures were included. The mean patient age was 76.1±8.1 years, and 58.9% were men. The mean CHA2DS2-VASc score was 4.8±1.5, whereas the mean hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol (HAS-BLED) score was 3.0±1.1. Prior stroke or transient ischemic attack was reported in 40.2% and prior bleeding in 70.1%, with gastrointestinal bleeding being most common (41.9%). The most common site-reported procedural indications for Watchman implantation were increased thromboembolic risk (64.8%) and history of major bleed (64.3%), followed by high fall risk (35.5%). Most (71.9%) had ≥2 procedural indications. Patients with high fall risk had increased risk of in-hospital adverse events (adjusted OR, 1.12; P=0.025), but no other differences were found in the risk of in-hospital adverse events by procedural indication. CONCLUSIONS: Among patients in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry, the most common procedural indications for Watchman implantation were increased thromboembolic risk, history of major bleed, and high fall risk. A majority of patients had multiple procedural indications. High fall risk conferred a modestly increased risk of in-hospital adverse events.
BACKGROUND: The Food and Drug Administration approved left atrial appendage occlusion with the Watchman device for patients who are at increased stroke risk and are suitable for oral anticoagulation but who have an appropriate reason to seek a nondrug alternative. These broad criteria raise the question of their interpretation in clinical practice. There is a lack of studies comprehensively evaluating the indications for Watchman implantation among a large series of patients from contemporary, real-world practice in the United States. METHODS: We used the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry to identify Watchman procedures performed between 2016 and 2018. We assessed procedural indications for Watchman implantation in the United States and evaluated the association between procedural indications and in-hospital adverse events. RESULTS: A total of 38 314 procedures were included. The mean patient age was 76.1±8.1 years, and 58.9% were men. The mean CHA2DS2-VASc score was 4.8±1.5, whereas the mean hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol (HAS-BLED) score was 3.0±1.1. Prior stroke or transient ischemic attack was reported in 40.2% and prior bleeding in 70.1%, with gastrointestinal bleeding being most common (41.9%). The most common site-reported procedural indications for Watchman implantation were increased thromboembolic risk (64.8%) and history of major bleed (64.3%), followed by high fall risk (35.5%). Most (71.9%) had ≥2 procedural indications. Patients with high fall risk had increased risk of in-hospital adverse events (adjusted OR, 1.12; P=0.025), but no other differences were found in the risk of in-hospital adverse events by procedural indication. CONCLUSIONS: Among patients in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry, the most common procedural indications for Watchman implantation were increased thromboembolic risk, history of major bleed, and high fall risk. A majority of patients had multiple procedural indications. High fall risk conferred a modestly increased risk of in-hospital adverse events.
Entities:
Keywords:
United States; anticoagulants; hospitals; humans; registries
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