Predictors of pocket hematoma in patients on antithrombotic therapy undergoing cardiac rhythm device implantation: insights from the FinPAC trial
: Wail Nammas, M. J. Pekka Raatikainen, Petri Korkeila, Juha Lund, Antti Ylitalo, Pasi Karjalainen, Vesa Virtanen, Ulla-Maija Koivisto, Seppo Utriainen, Tuija Vasankari, Juhani Koistinen, K. E. Juhani Airaksinen
: 2014
: Annals of Medicine
: Annals of Medicine
: Ann.Med.
: 46
: 3
: 177
: 181
: 5
: 0785-3890
: 1365-2060
DOI: https://doi.org/10.3109/07853890.2014.894285
Background. The FinPAC trial showed that the strategy of uninterrupted oral anticoagulation (OAC) was non-inferior to interrupted OAC for the primary outcome of bleeding and thromboembolic complications in patients undergoing cardiac rhythm management device (CRMD) implantation. Methods. We conducted a post hoc analysis of the FinPAC data to explore the incidence and predictors of significant (> 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 significant pocket hematoma during hospital stay was significantly higher among patients using OAC (5.6%) and aspirin (5.5%) than in those with no antithrombotic 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 preprocedural features predicted the significant hematoma in any of the groups. Conclusions. Clinically significant pocket hematoma is a rare complication after CRMD implantation in patients with ongoing therapeutic OAC. The incidence of significant pocket hematoma formation is similar in patients using OAC and those using aspirin.