Leadless Pacemaker Implant, Anticoagulation Status, and Outcomes: Results From The Micra Transcatheter Pacing System Post-Approval Registry.

BACKGROUND Early results from the Micra investigational trial and Micra post-approval registry (PAR) demonstrated excellent safety and device performance; however, outcomes based upon anticoagulation status at implant have not been evaluated. OBJECTIVE To report implant characteristics, perforation rate and vascular related events based upon perioperative oral anticoagulation (AC) strategy in patients undergoing Micra implant. METHODS We compared procedure characteristics, major complications, and vascular events, including pericardial effusion, stratified by any AE (including major complications, minor complications and observations) or major complication only according to AC status in the Micra PAR. RESULTS Among 1795 patients with AC status available, 585 were not on AC, 795 had AC interrupted, and 415 had AC continued during Micra implant. Non-AC patients tended to be younger, with less history of AF and COPD, and more history of dialysis than interrupted and continued patients. The implant success rate was similar for all groups (99.1%-99.8%). Through 30 days post implant, the overall major complication rate was 3.1% for the non-AC group, 2.6% for the interrupted group, and 1.5% for the continued group. The combined rate for any vascular or pericardial effusion AE did not differ significantly between AC strategies (6.5%, 4.8%, and 3.6% respectively). CONCLUSION Implant of Micra appears to be safe and feasible regardless of an interrupted or continued peri-procedural oral anticoagulation strategy, with no increased risk of perforation rate or vascular complications.