Yoshinari Enomoto1, Varuna K Gadiyaram2, Carola Gianni3, Rodney P Horton4, Chintan Trivedi5, Sanghamitra Mohanty6, Luigi Di Biase7, Amin Al-Ahmad5, J David Burkhardt5, Arvin Narula2, Gwen Janczyk2, Matthew J Price2, Muhammad R Afzal8, Moustapha Atoui8, Matthew Earnest8, Vijay Swarup9, Shephal K Doshi10, Sarina van der Zee10, Rebecca Fisher1, Dhanunjaya R Lakkireddy8, Douglas N Gibson2, Andrea Natale11, Vivek Y Reddy12. 1. Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, New York. 2. Interventional Electrophysiology, Scripps Clinic, La Jolla, California. 3. Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy. 4. Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas; Department of Biomedical Engineering, University of Texas, Austin, Texas. 5. Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas. 6. Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas; Dell Medical School, University of Texas, Austin, Texas. 7. Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas; Department of Biomedical Engineering, University of Texas, Austin, Texas; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; Department of Clinical and Experimental Medicine, University of Foggia, Foggia, Italy. 8. Division of Cardiovascular Diseases, University of Kansas Medical Center, Kansas City, Kansas. 9. Arizona Heart Rhythm Center, Phoenix, Arizona. 10. Pacific Heart Institute, Providence St. Johns Health Center, Santa Monica, California. 11. Interventional Electrophysiology, Scripps Clinic, La Jolla, California; Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas; Department of Biomedical Engineering, University of Texas, Austin, Texas; Dell Medical School, University of Texas, Austin, Texas; MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio; Division of Cardiology, Stanford University, Stanford, California,; Electrophysiology and Arrhythmia Services, California Pacific Medical Center, San Francisco, California. 12. Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: vivek.reddy@mountsinai.org.
Abstract
BACKGROUND: In the stroke prevention trials of left atrial appendage closure with the Watchman device (Boston Scientific), a postimplantation antithrombotic regimen of 6 weeks of warfarin was used. OBJECTIVE: Given the clinical complexity of warfarin use, the purpose of this study was to study the relative feasibility and safety of using non-warfarin oral anticoagulants (NOACs) instead of warfarin during the peri- and initial postimplantation periods after Watchman implantation. METHODS: This was a retrospective multicenter study of consecutive patients undergoing Watchman implantation and receiving peri- and postprocedural NOACs or warfarin. Transesophageal echocardiography or chest computed tomography was performed between 6 weeks and 4 months postimplant to assess for device-related thrombosis. Bleeding and thromboembolic events also were evaluated at the time of follow-up. RESULTS: In 5 centers, 214 patients received NOACs (46% apixaban, 46% rivaroxaban, 7% dabigatran, and 1% edoxaban) in either an uninterrupted (82%) or a single-held-dose (16%) fashion. Compared to a control group receiving uninterrupted warfarin (n = 212), the rates of periprocedural complications, including bleeding events, were similar (2.8% vs 2.4%, P = 1). At follow-up, the rates of device-related thrombosis (0.9% vs 0.5%, P = 1), composite of thromboembolism or device-related thrombosis (1.4% vs 0.9%, P = 1), and postprocedure bleeding events (0.5% vs 0.9%, P = .6) also were comparable between the NOAC and warfarin groups. CONCLUSION: NOACs proved to be a feasible peri- and postprocedural alternative regimen to warfarin for preventing device-related thrombosis and thromboembolic complications expected early after appendage closure with the Watchman device, without increasing the risk of bleeding.
BACKGROUND: In the stroke prevention trials of left atrial appendage closure with the Watchman device (Boston Scientific), a postimplantation antithrombotic regimen of 6 weeks of warfarin was used. OBJECTIVE: Given the clinical complexity of warfarin use, the purpose of this study was to study the relative feasibility and safety of using non-warfarin oral anticoagulants (NOACs) instead of warfarin during the peri- and initial postimplantation periods after Watchman implantation. METHODS: This was a retrospective multicenter study of consecutive patients undergoing Watchman implantation and receiving peri- and postprocedural NOACs or warfarin. Transesophageal echocardiography or chest computed tomography was performed between 6 weeks and 4 months postimplant to assess for device-related thrombosis. Bleeding and thromboembolic events also were evaluated at the time of follow-up. RESULTS: In 5 centers, 214 patients received NOACs (46% apixaban, 46% rivaroxaban, 7% dabigatran, and 1% edoxaban) in either an uninterrupted (82%) or a single-held-dose (16%) fashion. Compared to a control group receiving uninterrupted warfarin (n = 212), the rates of periprocedural complications, including bleeding events, were similar (2.8% vs 2.4%, P = 1). At follow-up, the rates of device-related thrombosis (0.9% vs 0.5%, P = 1), composite of thromboembolism or device-related thrombosis (1.4% vs 0.9%, P = 1), and postprocedure bleeding events (0.5% vs 0.9%, P = .6) also were comparable between the NOAC and warfarin groups. CONCLUSION:NOACs proved to be a feasible peri- and postprocedural alternative regimen to warfarin for preventing device-related thrombosis and thromboembolic complications expected early after appendage closure with the Watchman device, without increasing the risk of bleeding.
Authors: Mohammed Osman; Tatiana Busu; Khansa Osman; Safi U Khan; Matthew Daniels; David R Holmes; Mohamad Alkhouli Journal: JACC Clin Electrophysiol Date: 2020-01-29
Authors: Jan Latal; Michal Pazdernik; Maria Holicka; Radek Pelouch; Jiri Widimsky; Jiri Pudich; Radek Vancata; Michal Siranec; Kamila Blechova; Tadeas Butta; Marketa Mikulcova; Michal Mikulica; Peter Wohlfahrt; Martin Hutyra; Jan Precek Journal: Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub Date: 2021-02-22 Impact factor: 1.245