James V Freeman1, Angela Y Higgins2, Yongfei Wang3, Chengan Du4, Daniel J Friedman5, Usama A Daimee6, Karl E Minges3, Lucy Pereira4, Andrew M Goldsweig7, Matthew J Price8, Vivek Y Reddy9, Douglas Gibson8, Shephal K Doshi10, Paul D Varosy11, Frederick A Masoudi12, Jeptha P Curtis3. 1. Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA; Center for Outcomes Research and Evaluation, Yale New Haven Health Services Corporation, New Haven, Connecticut, USA. Electronic address: james.freeman@yale.edu. 2. Division of Cardiology, Maine Health, Scarborough, Maine, USA. 3. Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA; Center for Outcomes Research and Evaluation, Yale New Haven Health Services Corporation, New Haven, Connecticut, USA. 4. Center for Outcomes Research and Evaluation, Yale New Haven Health Services Corporation, New Haven, Connecticut, USA. 5. Division of Cardiology, Duke University School of Medicine, Durham, North Carolina, USA. 6. Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. 7. Division of Cardiovascular Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA. 8. Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA. 9. Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, New York, USA. 10. Division of Cardiology, St John's Health Center, Pacific Heart Institute, Santa Monica, California, USA. 11. Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA; Veterans Affairs Eastern Colorado Health Care System, Aurora, Colorado, USA. 12. Ascension Health, St Louis, Missouri, USA.
Abstract
BACKGROUND: Pivotal trials of percutaneous left atrial appendage occlusion (LAAO) used specific postprocedure treatment protocols. OBJECTIVES: This study sought to evaluate patterns of postprocedure care after LAAO with the Watchman device in clinical practice and compare the risk of adverse events for different discharge antithrombotic strategies. METHODS: We evaluated patients in the LAAO Registry of the National Cardiovascular Data Registry who underwent LAAO with the Watchman device between 2016 and 2018. We assessed adherence to the full postprocedure trial protocol including standardized follow-up, imaging, and antithrombotic agents and then evaluated the most commonly used antithrombotic strategies and compared the rates and risk of adverse events at 45 days and 6 months by means of multivariable COX frailty regression. RESULTS: Among 31,994 patients undergoing successful LAAO, only 12.2% received the full postprocedure treatment protocol studied in pivotal trials; the most common protocol deviations were with discharge antithrombotic medications. The most common discharge medication strategies were warfarin and aspirin (36.9%), direct oral anticoagulant (DOAC) and aspirin (20.8%), warfarin only (13.5%), DOAC only (12.3%), and dual antiplatelet therapy (5.0%). In multivariable Cox frailty regression, the adjusted risk of any adverse event through the 45-day follow-up visit were significantly lower for discharge on warfarin alone (HR: 0.692; 95% CI: 0.569-0.841) and DOAC alone (HR: 0.731; 95% CI: 0.574-0.930) compared with warfarin and aspirin. Warfarin alone retained lower risk at the 6-month follow-up. CONCLUSIONS: In contemporary U.S. practice, practitioners rarely used the full U.S. Food and Drug Administration-approved postprocedure treatment protocols studied in pivotal trials of the Watchman device. Discharge after implantation on warfarin or DOAC without concomitant aspirin was associated with lower risk of adverse outcomes.
BACKGROUND: Pivotal trials of percutaneous left atrial appendage occlusion (LAAO) used specific postprocedure treatment protocols. OBJECTIVES: This study sought to evaluate patterns of postprocedure care after LAAO with the Watchman device in clinical practice and compare the risk of adverse events for different discharge antithrombotic strategies. METHODS: We evaluated patients in the LAAO Registry of the National Cardiovascular Data Registry who underwent LAAO with the Watchman device between 2016 and 2018. We assessed adherence to the full postprocedure trial protocol including standardized follow-up, imaging, and antithrombotic agents and then evaluated the most commonly used antithrombotic strategies and compared the rates and risk of adverse events at 45 days and 6 months by means of multivariable COX frailty regression. RESULTS: Among 31,994 patients undergoing successful LAAO, only 12.2% received the full postprocedure treatment protocol studied in pivotal trials; the most common protocol deviations were with discharge antithrombotic medications. The most common discharge medication strategies were warfarin and aspirin (36.9%), direct oral anticoagulant (DOAC) and aspirin (20.8%), warfarin only (13.5%), DOAC only (12.3%), and dual antiplatelet therapy (5.0%). In multivariable Cox frailty regression, the adjusted risk of any adverse event through the 45-day follow-up visit were significantly lower for discharge on warfarin alone (HR: 0.692; 95% CI: 0.569-0.841) and DOAC alone (HR: 0.731; 95% CI: 0.574-0.930) compared with warfarin and aspirin. Warfarin alone retained lower risk at the 6-month follow-up. CONCLUSIONS: In contemporary U.S. practice, practitioners rarely used the full U.S. Food and Drug Administration-approved postprocedure treatment protocols studied in pivotal trials of the Watchman device. Discharge after implantation on warfarin or DOAC without concomitant aspirin was associated with lower risk of adverse outcomes.
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Authors: James V Freeman; Paul Varosy; Matthew J Price; David Slotwiner; Fred M Kusumoto; Chidambaram Rammohan; Clifford J Kavinsky; Zoltan G Turi; Joseph Akar; Cristina Koutras; Jeptha P Curtis; Frederick A Masoudi Journal: J Am Coll Cardiol Date: 2020-04-07 Impact factor: 24.094
Authors: Lucas V A Boersma; Boris Schmidt; Timothy R Betts; Horst Sievert; Corrado Tamburino; Emmanuel Teiger; Evgeny Pokushalov; Stephan Kische; Thomas Schmitz; Kenneth M Stein; Martin W Bergmann Journal: Eur Heart J Date: 2016-01-27 Impact factor: 29.983