Over 1.6 million pacing or cardioverter defibrillator (ICD) devices are implanted worldwide annually and up to 1\/3 of this cohort have an indication for long-term anticoagulation therapy. Current guidelines suggest discontinuing the oral anticoagulant and initiating bridging therapy with heparin but this strategy is associated with increased costs, a short but high risk period of normal coagulability, and of itself is associated with a pocket haematoma rate of between 20 to 30%. Small case series have suggested that it may be safe to perform surgery without interrupting warfarin treatment but thus far no adequately powered prospective trial has reported on this strategy.<\/p>\n
In the BRUISE-CONTROL study, 681 patients taking warfarin and requiring device implantation were randomly assigned in a 1:1 ratio to continued warfarin treatment or to bridging therapy with heparin. The primary outcome was clinically significant device-pocket haematoma, which was defined as device-pocket haematoma that necessitated prolonged hospitalization, interruption of anticoagulation therapy, or further surgery. The trial was terminated early after a prespecified interim analysis, which strongly favoured continuation of warfarin therapy. Clinically significant pocket haematoma occurred in 12 of 343 patients (3.5%) in the warfarin group, as compared with 54 of 338 (16.0%) in the heparin group (RR, 0.19; 95% CI, 0.10 to 0.36; P<0.001). Major surgical and thromboembolic complications were rare and did not differ significantly between the study groups. They included one episode of cardiac tamponade and one myocardial infarction in the heparin-bridging group and one stroke and one transient ischaemic attack in the warfarin group.<\/p>\n
Conclusions:<\/strong><\/p>\n In this large multi-center prospective study, as compared with bridging therapy with heparin, a strategy of continued warfarin treatment at the time of pacemaker or ICD implantation significantly reduced the incidence of pocket haematomas.<\/p>\n