A comparison of postoperative complications following cardiac implantable electronic device procedures in patients treated with antithrombotic drugs.

BACKGROUND: The incidence of postoperative complications following cardiac implantable electronic device (CIED) procedures in patients treated with antithrombotic drugs has not been studied sufficiently. Here we present a comparison of complications after CIED implantations.

METHODS: Using an observational study design, the study included 1807 patients with a taking antiplatelet drugs (n: 1601), nonvitamin K anticoagulants (NOAC) (n: 136), and warfarin (n: 70) undergoing CIED surgery. Primary endpoint was accepted as cumulative events including composite of clinically significant hematoma (CSH), pericardial effusion or tamponade, pneumothorax, and infection related to device system. Secondary outcomes included each compenent of cumulative events. Multivariable analysis was performed to identify predictors of cumulative events.

RESULTS: The overall cumulative event rate was 3.7% (67 of 1807). Cumulative events occured 3.1% (50 of 1601) in the antiplatelet, 5.1% (7 of 136) NOAC, and 14.3% (10 of 70) warfarin groups (p < 0.001). CSH occurred in 2 of 70 patients (2.9%) in the warfarin group, as compared with 5 of 1601 (0.3%) in the antiplatelet group (p: 0.032). However, no significant differences were found between NOAC and warfarin groups in terms of CSH (0.7% vs. 2.9% respectively, p: 0.267). Warfarin treatment was an independent predictor of cumulative events and increased 2.9-fold the risk of cumulative events. Major surgical complications were rare and did not differ significantly between the study groups.

CONCLUSIONS: The incidence and severity of complications may be lower in patients treated with periprocedurally antiplatelet or NOAC therapy when compared with warfarin therapy. Further randomized control studies are required to confirm our findings.