Safety of Continuous Anticoagulation With Dabigatran During Implantation of Cardiac Rhythm Devices

Study Questions:

What are the safety and bleeding risks of continuous anticoagulation with dabigatran during implantation of cardiac implantable electronic devices (CIEDs)?


This was a prospective, observational study. Twenty-five consecutive patients undergoing implantation of an initial pacemaker, implantable cardioverter-defibrillator (ICD), cardiac resynchronization device, or pulse generator replacement and receiving anticoagulation with dabigatran within 48 hours of the procedure were included. Study endpoints included major bleeding, minor bleeding, and thrombotic complications during the index hospitalization and at 30 days of follow-up.


The last dose of dabigatran was given 16 ± 15 hours before implantation, and the first dose of the anticoagulant was given 17 ± 16 hours after the procedure. In 11 patients (44%), dabigatran was administered uninterrupted with no missed doses. During the index hospitalization, no thromboembolic or bleeding complications developed. No major bleeding complications occurred within 30 days of surgery. One minor bleeding event (pocket hematoma that did not require additional intervention or discontinuation of dabigatran) occurred in one patient within 30 days of implantation; this patient was also receiving dual antiplatelet therapy.


The authors concluded that continuous anticoagulation with dabigatran during implantation of CIEDs may be safe, and is not associated with appreciable risk for bleeding and/or thromboembolic complications.


The present analysis is limited by the small size and infrequent number of bleeding complications during device implantation. Only 11 patients received dabigatran without any interruption. Additional studies are necessary to establish optimal antithrombotic management practices during implantation of CIEDs among patients using newly approved oral anticoagulant agents.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Implantable Devices, SCD/Ventricular Arrhythmias, Novel Agents

Keywords: Follow-Up Studies, Disease Management, Hematoma, Cardiac Resynchronization Therapy, Blood Coagulation, Safety, beta-Alanine, Benzimidazoles, Pacemaker, Artificial, Hemorrhage, Defibrillators, Implantable

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