Predictors of pocket hematoma in patients on antithrombotic therapy undergoing cardiac rhythm device implantation: insights from the FinPAC trial

Background. The FinPAC trial showed that the strategy of uninter- rupted oral anticoagulation (OAC) was non-inferior to interrupted OAC for the primary outcome of bleeding and thromboembolic complications in patients undergoing cardiac rhythm manage- ment device (CRMD) implantation. Methods. We conducted a post hoc analysis of the FinPAC data to explore the incidence and predictors of signifi cant ( 100 cm 2 ) pocket hematoma after CRMD implantation among the study population ( n 447). A total of 213 patients were on OAC, 128 were on aspirin, and 106 on no antithrombotic therapy. Results. The incidence of signifi cant pocket hematoma during hospital stay was signifi cantly higher among patients using OAC (5.6%) and aspirin (5.5%) than in those with no antithrom- botic medications (0.9%), but only one patient (0.8%) in the aspirin group needed revision of hematoma. Two patients (0.9%) in the OAC group and one (0.8%) in the aspirin group needed blood products. In multivariable regression analysis, no pre- procedural features predicted the signifi cant hematoma in any of the groups. Conclusions. Clinically signifi cant pocket hematoma is a rare complication after CRMD implantation in patients with ongoing therapeutic OAC. The incidence of signifi cant pocket hematoma formation is similar in patients using OAC and those using aspirin.