Arrhythmias & electrophysiology

Multicenter Results of a Novel Pediatric Pacemaker in Neonates and Infants

Circ Arrhythm ElectrophysiolPublished Multicenter report

Authors' conclusion

The pediatric implantable pulse generator can be safely implanted in neonates and infants. This multicenter report demonstrates that the devices remain stable, with effective pacing, normal electrical parameters, and battery longevity aligned with projections. This novel pediatric pacemaker provides a viable alternative to standard-size generators and addresses a vital unmet need for these small patients.

Study context

Population
Neonates and infants who underwent implantation of a pediatric implantable pulse generator (Medtronic Micra subassembly in a polymer header connecting to a bipolar epicardial lead), March 2022 to February 2024all patients at 12 sites within the timeframe
Participants
29 neonates
Outcome
Device parameters (most recent)
Follow-up
Average duration of implant 325 days (73-808 days)
Methodological detailsdeidentified data, 12 of 15 sites in the United States
  • Deidentified data
  • 12 of 15 sites in the United States

Main finding

As reported in the abstract

Lead impedance mean

612 ohms

450–840 ohms

Ventricular capture threshold mean

1 V @ 0.4 ms

range, 0.38–2.75 V

R-wave sensing mean

12.5 mV

3.6–20 mV

Further findings

Generator explants · removed at 6.5 to 31 months of age

Generator explants
7 (24%)

Baseline characteristics · at implant

Median age at implant
15 days (range, 0 days to 3 years, including 1 outlier)
Median weight
2.3 kg (range, 1.3-11.4 kg)
Gestational age
28.5 weeks to term
Born prematurely
23 (79%)
Congenital heart disease, of those with anatomic information
25%

Original publication

Multicenter Results of a Novel Pediatric Pacemaker in Neonates and Infants. Circ Arrhythm Electrophysiol. Published 25 February 2025. doi:10.1161/circep.124.013436

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