Introduction: Data on peri-operative management of direct-acting oral anticoagulants (DOACs) during transcatheter pacing leadless system (TPS) implantations remain limited. This study aimed to evaluate a standardized DOAC management regime consisting of interruption of a single dose prior to implantation and reinitiation within 6-24 h; also, patient clinical characteristics associated with this approach were identified.
Method: Consecutive patients undergoing standard TPS implantation procedures from two Swiss tertiary centers were included. DOAC peri-operative management included the standardized approach (Group 1A) or other approaches (Group 1B).
Results: Three hundred and ninety-two pts (mean age 81.4 ± 7.3 years, 66.3% male, left ventricular ejection fraction 55.5 ± 9.6%) underwent TPS implantation. Two hundred and eighty-two pts (71.9%) were under anticoagulation therapy; 192 pts were treated with DOAC; 90 pts were under vitamin-K antagonist. Patients treated with DOAC less often had structural heart disease, diabetes mellitus, and advanced renal failure. The rate of major peri-procedural complications did not differ between groups 1A (n = 115) and 1B (n = 77) (2.6% and 3.8%, p = 0.685). Compared to 1B, 1A patients were implanted with TPS for slow ventricular rate atrial fibrillation (AF) (p = 0.002), in a better overall clinical status, and implanted electively (<0.001).
Conclusions: Standardized peri-procedural DOAC management was more often implemented for elective TPS procedures and did not seem to increase bleeding or thromboembolic adverse events.
Keywords: anticoagulation management; bleeding complications in leadless pacemaker; direct-acting oral anticoagulants’ management; leadless pacemaker implantation; leadless pacing.