What are the incidence, characteristics, and outcomes of leadless pacemaker revisions, and is device removal safe and feasible in patients with implanted Micra devices?
Leadless pacemaker revisions are rare (1.1%) and predominantly managed without removal, but device removal is highly successful (97%) and safe, suggesting it could be considered more frequently.
AIMS: Leadless pacemakers (LLPs) offer a valuable option for selected patients requiring ventricular pacing. However, data on revision procedures-defined as any intervention on an implanted LLP to correct dysfunction or upgrade the system, with or without removal-remain scarce. This study aimed to evaluate the real-world incidence, characteristics, and outcomes of LLP revisions, with particular emphasis on the feasibility and safety of removal. METHODS AND RESULTS: This multicentre retrospective study involved 46 French centres performing LLP implantations between 2015 and 2023. Among 8994 Micra LLPs implanted, 100 revision procedures (1.1%) were performed in 100 patients, including 73 Micra VR and 27 Micra AV devices, at a median follow-up of 229 (68.5-629.8) days. Seventy revisions were managed without device removal, while 30 involved removal. Revision indications included device upgrade (55%), high pacing threshold (33%), battery depletion (3%), ventricular arrhythmias (3%), and miscellaneous causes (6%). No significant differences were observed in pacing indications, implantation characteristics, or initial device indication between the two groups. Revisions occurred significantly earlier in the removal group than in the group without removal median 81.5 (8-211.5) days, vs. 334 (130.25-882.5) days, P < 0.001, with 80% occurring within 1 year. Device removal was successful in 97% of cases (one failure at 157 days of follow-up), with no major complications reported. CONCLUSION: LLP revisions are infrequent and predominantly managed without device removal. However, given the high procedural success rate and the low complication rate, device removal appears to be underutilized and should be considered more frequently on a case-by-case basis.
Jacon et al. (Mon,) studied this question.