Abstract 13275: Bleeding Complications Following Pacemaker or Internal Cardioverter-Defibrillator Implantation Among Patients Receiving Dabigatran
Background: Patients (pts) undergoing placement of pacemakers (PPMs) or internal cardioverter-defibrillators (ICDs) requiring anticoagulation (AC) may have increased risk of thromboembolic (TE) events if AC is interrupted, but may have increased bleeding if AC is continued. Current guidelines recommend heparin bridging for device implantation, although multiple studies indicate that continuing warfarin is safer. The bleeding risks associated with device implantation on dabigatran are unknown.
Methods: In this prospective study, we evaluated 25 consecutive pts with atrial fibrillation (AF) undergoing device implantation who were anticoagulated with dabigatran. Major complications were defined as bleeding requiring surgical intervention, discontinuation of AC or transfusion of blood products within 30 days of surgery. Minor complications included the development of a hematoma.
Results: The cohort was 66 ± 11 years old, 88% male, and the mean CHADS2 score was 2.1 ± 1.4. Implant procedures consisted of 6 ICDs (24%), 9 PPMs (36%), 5 CRT (20%), and 5 pulse generator change outs (20%). There were various dabigatran dosing strategies perioperatively, most commonly with AC held the day of the procedure. However, 11 pts underwent implantation without interruption of dabigatran. These 11 pts had similar CHADS2 scores to the remaining cohort (2 ± 1.7 vs 2.2 ± 1) but were more likely to have recent or planned cardioversion (73% vs 21%, respectively p = 0.02). The mean time between the last dose of AC and implant was 26 ± 16 hours for the group with interrupted AC and 5 ± 3 hours for the uninterrupted group (p = 0.0003). The mean time between implant and the first dose of AC was 27 ± 19 hours in the interrupted group and 8 ± 3 hours in the uninterrupted group (p = 0.004). There were no major bleeding or TE events observed. One pt (4%) had a hematoma not requiring intervention while receiving dual antiplatelet therapy and uninterrupted AC due to a CHADS2 score of 6. The relative risk for minor complications of uninterrupted dabigatran was 0.9 (95% CI 0.72 to 1.14, p = 0.4).
Conclusion: Patients with AF treated with dabigatran can safely undergo device implantation without discontinuation of AC. Further study is needed to define the optimal dosing strategy of dabigatran perioperatively.
- © 2012 by American Heart Association, Inc.