Use of non-warfarin oral anticoagulants instead of warfarin during left atrial appendage closure with the Watchman device

Yoshinari Enomoto; Varuna K Gadiyaram; Carola Gianni; Rodney P Horton; Chintan Trivedi; Sanghamitra Mohanty; Luigi Di Biase; Amin Al-Ahmad; J David Burkhardt; Arvin Narula; Gwen Janczyk; Matthew J Price; Muhammad R Afzal; Moustapha Atoui; Matthew Earnest; Vijay Swarup; Shephal K Doshi; Sarina van der Zee; Rebecca Fisher; Dhanunjaya R Lakkireddy; Douglas N Gibson; Andrea Natale; Vivek Y Reddy

doi:10.1016/j.hrthm.2016.10.020

Use of non-warfarin oral anticoagulants instead of warfarin during left atrial appendage closure with the Watchman device

Heart Rhythm. 2017 Jan;14(1):19-24. doi: 10.1016/j.hrthm.2016.10.020. Epub 2016 Oct 19.

Authors

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

Affiliations

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.

PMID: 27771552
DOI: 10.1016/j.hrthm.2016.10.020

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.

Keywords: Device-related thrombosis; Left atrial appendage; Non-warfarin oral anticoagulants; Stroke; Thromboembolism; Watchman.

Publication types

Multicenter Study
Observational Study

MeSH terms

Administration, Oral
Aged
Aged, 80 and over
Anticoagulants / administration & dosage*
Anticoagulants / pharmacology
Atrial Appendage / diagnostic imaging*
Atrial Appendage / drug effects
Atrial Appendage / surgery*
Atrial Fibrillation / prevention & control
Cohort Studies
Echocardiography, Transesophageal / methods
Female
Follow-Up Studies
Humans
Male
Prostheses and Implants
Prosthesis Implantation / adverse effects*
Prosthesis Implantation / methods
Retrospective Studies
Risk Assessment
Thromboembolism / etiology
Thromboembolism / prevention & control*
Treatment Outcome
Warfarin / administration & dosage

Substances

Anticoagulants
Warfarin