Pacemaker Implantation in Elderly Patients: Safety of Various Regimens of Anticoagulant Therapy.

Abstract

To study incidence of hemorrhagic complications after pacemaker implantation in elderly patients receiving antithrombotic therapy with warfarin or uninterrupted dabigatran. 126 patients aged 83 [82; 85] years who receive continuous antithrombotic therapy after pacemaker implantation, were enrolled in the study. Adverse event data were collected during hospitalization and further 12 weeks. 95 subjects (75.4%) from general number of enrolled patients received elective anticoagulant warfarin therapy and 31 subjects (24.6%) were treated with dabigatran. All patients of dabigatran group received 220 mg/day skipping the last dose before a surgery and resumed the drug intake in 36-48 hours after it. Patients of warfarin group underwent surgery if INR was NMT 3; they didn't stop taking the drug for the duration of operation.No statistically significant differences of hematoma incidence were detected in dabigatran (incidence is 0.065, 95%CI (-0.02-0.15)) and warfarin (incidence is 0.05, 95%CI (0.006-0.01)) groups, p(Fisher)= 0.55. Three cases of nonfatal gastrointestinal bleeding (warfarin group) and 1 similar event in dabigatran group were detected during a follow-up (12 [6; 20] weeks): RR= 0.98 (warfarin group), p(Fisher)=0.68. No statistically significant difference of age, sex composition, history of IHD and diabetes was detected between groups by comparison of individual characteristics of patients whose surgeries were complicated/non-complicated by hematoma formation. Upon that, hematoma formation rate was significantly higher in patients with adjunctive pacemaker muscular fixation: 71.4% vs 31.9% (patients without hematomas), p(Fisher)= 0.045. Incidence of hematoma formation after pacemaker implantation in patients > 75 years receiving warfarin or dabigatran, is the same as in general population of patients treated with anticoagulants. Adjunctive pacemaker muscular fixation is a significant risk factor of hematoma formation.