Bleeding risk of submuscular ICD implantation with continued oral anticoagulation versus heparin bridging therapy

Recent studies have shown that subcutaneous or subfascial pacemaker- and ICD implantation with continued oral anticoagulation therapy is associated with lower risk for bleeding complications, when compared to heparin bridging strategies. However, ICD generators are often implanted submuscularly. We therefore compared the bleeding risk with continued phenprocoumon therapy vs. heparin bridging in patients receiving submuscular ICD implantation. Between 01/2013 and 12/2013, 104 patients with need for oral anticoagulation received submuscular ICD or CRT-D implantation in our institution. 46 patients were implanted under continued phenprocoumon therapy while 58 patients received heparin bridging for implantation procedure. All ICD generators were placed submuscularly. The primary outcome of the study was clinically significant bleeding or device pocket hematoma with need for surgical revision. Mean patients age was 63.7 years, 72.1% were male. In patients with heparin bridging therapy, preoperative INR prior to ICD implantation was 1.2 ± 0.31 while in the group of patients on continued phenprocoumon therapy, mean pre-OP INR was 2.4 ± 0.47. In heparin bridging group, 8 (13.8%) patients experienced a clinically relevant pocket hematoma, while only 1 (2.2%) patient on continued phenprocoumon therapy needed surgical revision for pocket hematoma (P = 0.04). No further bleeding complications or clinically relevant pericardial effusion was observed in any of the groups and no perioperative thromboembolic event occurred. Submuscular ICD implantation under continued phenprocoumon therapy was safe and feasible. Compared to patients with heparin bridging therapy, those with continued phenprocoumon therapy had a lower incidence of clinically relevant bleeding complications.