Transcatheter Leadless Pacemakers viable pacing option for pediatric patients and those with congenital heart disease

USA: Transcatheter Leadless Pacemakers (TLP) may be a viable option for pediatric patients and those with congenital heart disease who cannot undergo traditional forms of pacemaker implantation, according to a study published in Circulation: Arrhythmia and Electrophysiology.

The research, conducted by the Pediatric and Congenital Electrophysiology Society, aimed to assess the safety and efficacy of TLP in children, a population that has been excluded from previous clinical trials.

The study collected retrospective data from 15 centers enrolled in the Pediatric and Congenital Electrophysiology Society TLP registry, including patients ≤21 years old who underwent Micra TLP implantation with ≥ 1-week follow-up.

Out of the 63 patients enrolled in the study 20 patients had congenital heart disease (32%) and the mean body weight at implantation was 55±19 kg, 8 patients were ≤8 years old and ≤30 kg. The TLP was implanted by femoral (87%) and internal jugular (12.6%) venous approaches.

The study concluded with the following clinical findings:

1. 1.Successful implantation in 98% of 63 registry patients aged 15±4.1 years.
2. 2.16% (10) of patients had complications during a 9.5±5.3-month follow-up period
3. 3.Complications included cardiac perforation/pericardial effusion, nonocclusive femoral venous thrombus, and TLP retrieval/replacement due to high thresholds.
4. 4.No deaths, TLP infections, or device embolizations.
5. 5.Electrical parameters including capture thresholds, R wave sensing, and pacing impedances remained stable.

The study’s findings suggest that TLP implantation is safe and effective in pediatric patients and those with congenital heart disease. However, the researchers noted that further long-term prospective data are needed to confirm the reproducibility of these initial findings.

This Lead author Dr. Maully Shah added that “This is important information for clinicians who treat pediatric patients with pacing indications. The use of TLP could potentially avoid the need for repeated sternotomies, thoracotomies, or transvenous systems, which can be difficult and risky in young patients.”

Reference:

Shah M., Borquez A., Cortez D., McCanta A., De Filippo P., Whitehill R., Imundo J., Moore J., Sherwin E., Howard T., Rosenthal E., Kertesz N., Chang P., Madan N., Kutalek S., Hammond B., Janson C., Iyer R., Williams M.; Transcatheter Leadless Pacing in Children: A PACES Collaborative Study in the Real-World Setting; Circulation: Arrhythmia and Electrophysiology. 2023;0:e011447; doi: https://doi.org/10.1161/CIRCEP.122.011447