Prevention of bleeding complications with local tranexamic acid use during cardiovascular implantable electronic device implantation
R Chantrakul, W BoonyapisitAbstract
Background
Most patients undergoing cardiovascular implantable electronic device (CIED) implantation have comorbid cardiovascular conditions, such as atrial fibrillation (AF), coronary artery disease (CAD), and ischemic stroke. As a result, approximately half of these patients are on antiplatelet or anticoagulant therapy, which increases the risk of device-related bleeding complications (DRBCs), particularly pocket hematomas. Various strategies exist for bleeding control, including the use of tranexamic acid, an antifibrinolytic drug.
Objective
This study aimed to evaluate the efficacy and safety of local tranexamic acid in controlling bleeding during CIED implantation procedures.
Method
A single-center, double-blind, randomized controlled trial was conducted. Patients undergoing CIED implantation and receiving antiplatelet and/or anticoagulant therapy were included. Participants were stratified and randomly assigned to receive either tranexamic acid or placebo. The two groups consisted of patients on single antiplatelet therapy, warfarin, novel oral anticoagulants, or combined medication. After pocket creation and bleeding check, three to five pieces of gauze soaked with 10 milliliters of the assigned fluid were placed prior to pulse generator (PG) device implantation. Outcomes, including pocket hematoma and other complications, were monitored the morning after the procedure and during outpatient follow-up at two weeks.
Results
A total of 132 patients were included: 66 in the intervention group and 66 in the control group. The procedures included 85 first implantations, 43 PG changes, 2 device upgrades, and 1 lead revision. The incidence of pocket hematoma was 9.1% in the intervention group and 7.6% in the control group (P = 0.75). DRBCs were observed in 16.7% of the intervention group and 19.7% of the control group (P = 0.65).
Conclusion
Local application of tranexamic acid during CIED implantation did not significantly reduce bleeding complications in patients undergoing the procedure.