Bleeding complications after implantation of active cardiovascular implantable devices in an era of triple therapy and novel antithrombotic drugs

Abstract

Introduction: Bleeding complications (eg. pocket hematoma) are still common complications after implantation of active cardiovascular implantable devices (CIEDs). We investigated the influence of the type of CIED, the implantation strategy, and the underlying antiplatelet- and anticoagulation-therapy on bleeding complication. Methods: Between 2006 and 2012, a total of 3,082 CIEDs (Pacemakers: n=1,689; ICD/CRT/CCM: n= 1393) were implanted at our institution. There was no perioperative anticoagulation in 17.7%, ASA or thienopyridine monotherapy in 33.5%, anticoagulation with phenprocoumon, heparins or novel oral anticoagulants (NOAKs) monotherapy in 16.3%, and a dual- or triple-combination of different antithrombotic drugs in 32.5% of the patients. HAS-BLED-score was >3 in 17.5% of the patients. Bleeding complications were defined as pocket hematoma, pericardial effusion, hematothorax, drop of hemoglobin >2mg/dl, and transfusion of >2 erythrocyte concentrates. Results: No patient died due to bleeding complications. The overall incidence of bleeding complications was 7,2%. Reoperation for pocket hematoma or hematothorax was required in 1.26%. Patients with HAS-BLED-Score >3, patients on dual- or triple combination of antithrombotic drugs, patients on low molecular weight heparins (LMWHs), and patients on dabigatran, ticagrelor or prasugrel exhibited a higher incidence for bleeding complications. Conclusions: Even in an era of novel antithrombotic drugs and dual-/triple-anticoagulation, the rate of bleeding complications is comparable to published data of the last decade. The use of bridging therapy with LMWHs and especially its combination with ASA/thienopyridine treatment are highly predictive for bleeding complications during or after CIEDs-surgery.