Leadless pacemaker implant, anticoagulation status, and outcomes: Results from the Micra Transcatheter Pacing System Post-Approval Registry

Abstract

Background: Early results from the Micra investigational trial and Micra Post-Approval Registry (PAR) demonstrated excellent safety and device performance; however, outcomes based on anticoagulation (AC) status at implant have not been evaluated.

Objective: The purpose of this study was to report implant characteristics, perforation rate, and vascular-related events based on perioperative oral AC strategy in patients undergoing Micra implant.

Methods: We compared procedure characteristics, major complications, and vascular events, including pericardial effusion, stratified by any adverse event (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 atrial fibrillation and chronic obstructive pulmonary disease, 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 postimplant, 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 adverse event did not differ significantly among AC strategies (6.5%, 4.8%, and 3.6%, respectively).

Conclusion: Implant of Micra seems to be safe and feasible regardless of an interrupted or continued periprocedural oral AC strategy, with no increased risk of perforation or vascular complications.

Trial registration: ClinicalTrials.gov NCT02536118.

Keywords: Anticoagulation; Bradycardia; Leadless pacemaker; Pacing; Vascular complications.