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

Objective: To study incidence of hemorrhagic complications after pacemaker implantation in elderly patients receiving antithrombotic therapy with warfarin or uninterrupted dabigatran.

Methods: 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.

Results: 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.

Conclusion: 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.