Key result
Micra leadless pacemaker implantation in centers without cardiac surgery resulted in similar acute complication rates compared to centers with cardiac surgery (0.8% vs. 0.5%; p=0.391).
Why the study?
Concerns initially limited Micra pacemaker implantation to centers with on-site cardiac surgery capabilities, and data comparing outcomes in centers with versus without cardiac surgery remain limited.
Does leadless pacemaker implantation in centers without cardiac surgery have similar safety and feasibility compared to centers with cardiac surgery?
Observational (n=1,899)
Yes
Does leadless pacemaker implantation in centers without cardiac surgery have similar safety and feasibility compared to centers with cardiac surgery?
Leadless pacemakers can be safely implanted in centers without on-site cardiac surgery, showing comparable complication rates to centers with surgical backup.
Answers are grounded in this paper and cite their sources.
Supports Micra implantation in non-CS centers; hypothesis-generating and requires prospective validation before practice change.
BACKGROUND: Micra leadless pacemaker offers an alternative to traditional transvenous pacemakers by eliminating the risks associated with leads and device pockets. Due to the technical demands of a leadless transcatheter pacemaker, concerns initially limited the procedure to centers with on-site cardiac surgery (CS) capabilities. However, growing evidence supports its safe implementation in noncardiac surgical centers, though data comparing outcomes in these settings remain limited. AIMS: This analysis aims to evaluate the safety and feasibility of Micra leadless pacemaker implantation in centers with and without CS, assessing acute complications, device performance, and patient follow-up. METHODS: A retrospective analysis was conducted on 1899 patients who received a Micra pacemaker from May 2015 to September 2024 at 23 centers. Patients were divided into two groups: those implanted in centers with CS (CS, n = 1025) and those without (No-CS, n = 874). The primary endpoint was acute complications within 15 days postimplant, while secondary endpoints included device performance and clinical follow-up at 12 months. RESULTS: The overall acute complication rate was low at 0.6%, with no significant difference between the CS (0.5%) and No-CS groups (0.8%; p = 0.391). Procedural times were slightly shorter in No-CS centers (41.2 ± 19.8 vs. 46.1 ± 19.3 min; p < 0.001), and both groups showed comparable device performance and patient outcomes over the follow-up period. CONCLUSION: The Micra leadless pacemaker can be safely and effectively implanted in centers without CS capabilities, broadening access to this technology across diverse clinical settings.
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Manzo et al. (2025) conducted an observational in Patients requiring pacemaker implantation (n=1,899). Implantation in centers without cardiac surgery vs. Implantation in centers with cardiac surgery was evaluated on Acute complications within 15 days postimplant (p=0.391). Micra leadless pacemaker implantation in centers without cardiac surgery resulted in similar acute complication rates compared to centers with cardiac surgery (0.8% vs. 0.5%; p=0.391).
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