Meta-Analysis of Bleeding Complications Associated With Cardiac Rhythm Device Implantation

Study Questions:

What is the risk of bleeding complications from device implantation in patients treated with different anticoagulant/antiplatelet therapies?


This was a meta-analysis of 13 studies that included 5,978 patients who underwent implantation of a pacemaker or implantable cardioverter-defibrillator (ICD). The risk of major and minor bleeding complications was compared between the following subgroups: no anticoagulant/antiplatelet therapy, anticoagulation held, anticoagulation continued, single antiplatelet therapy (SAP), dual antiplatelet therapy (DAP), and heparin bridging (HB). Major bleeding was defined as pericardial effusion, hemothorax, life-threatening bleed, or bleeding requiring transfusion or surgical intervention.


The rate of bleeding complications was approximately 2% in the no therapy group. After adjustment for study heterogeneity, the odds of bleeding relative to no therapy were increased by 8.3 with HB, by 5.0 with DAP, by 1.7 with anticoagulation held, by 1.6 with anticoagulation continued, and by 1.5 with SAP. Major bleeding events were significantly more common with HB (2%) and DAP (1.9%) than in the other groups (0.1-0.5%).


The authors concluded that HB and DAP are associated with the highest risk of bleeding complications related to device implantation.


Studies published in the past 3 years have indicated that uninterrupted warfarin has a more favorable risk:benefit ratio than interrupted warfarin plus HB in patients undergoing radiofrequency catheter ablation of atrial fibrillation. This meta-analysis confirms that the same is true for device implants. Of note is that the risk of bleeding was just as high with DAP than with HB. Therefore, if possible, coronary artery stenting and device implants should be separated by at least 6 weeks. Furthermore, a bare-metal stent may be preferable to a drug-eluting stent in patients who are potential candidates for a pacemaker or ICD over the short-term.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Implantable Devices, SCD/Ventricular Arrhythmias

Keywords: Defibrillators, Warfarin, Heparin, Pacemaker, Artificial

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