Meta-analysis of bleeding complications associated with cardiac rhythm device implantation.

BACKGROUND Many patients receiving cardiac rhythm devices have conditions requiring antiplatelet (AP) and/or anticoagulant (AC) therapy. Current guidelines recommend a heparin-bridging strategy (HBS) for anticoagulated patients with moderate/high risk for thrombosis. Several studies reported lower bleeding risk with continued oral anticoagulation rather than HBS. The best strategy for perioperative management of patients on AP therapy is less clear. The present study was designed as a meta-analysis of device implantation-associated bleeding complications using different AC/AP therapies. METHODS AND RESULTS PubMed and Cochrane Database searches identified articles based on design, outcomes, and available data. Device recipients were grouped as follows: no therapy, aspirin only, AC held, AC continued, dual AP, and HBS. The primary outcome was defined as a bleeding complication including hematoma, transfusion, or prolonged hospital stay. Thirteen articles were identified for analysis including 5978 patients. The combined incidence of bleeding complications was 274 of 5978 (4.6%), ranging from 2.2% (no therapy) to 14.6% (HBS). The estimated odds of bleeding were increased by 8.3 (95% CI, 5.5-12.9) times in the HBS group, 5.0 (95% CI, 3.0-8.3) for dual AP therapy, 1.7 (95% CI, 1.0-3.1) for AC held, 1.6 (95% CI, 0.9-2.6) for AC continued, and 1.5 (95% CI, 0.9-2.3) for aspirin only relative to the no therapy group. HBS significantly increased bleeding events compared with holding or continuing AC. Continuing AC did not increase bleeding events compared with no therapy. CONCLUSIONS Continuing AC appears safer than HBS for device implantation. Dual AP therapy but not continuing AC carries a significant risk of bleeding.