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Transcatheter Leadless Pacing in Children: A PACES Collaborative Study in the Real-World Setting
Journal article   Open access   Peer reviewed

Transcatheter Leadless Pacing in Children: A PACES Collaborative Study in the Real-World Setting

Maully J Shah, Alejandro A Borquez, Daniel Cortez, Anthony C McCanta, Paolo De Filippo, Robert D Whitehill, Jason R Imundo, Jeremy P Moore, Elizabeth D Sherwin, Taylor S Howard, …
Circulation. Arrhythmia and electrophysiology, v 16(4), e011447
Apr 2023
PMID: 37039017
url
https://doi.org/10.1161/circep.122.011447View
Published, Version of Record (VoR)Maybe Open Access (Publisher Bronze) Open
url
https://doi.org/10.1161/CIRCEP.122.011447View
Published, Version of Record (VoR) Open

Abstract

Adolescent Adult Arrhythmias, Cardiac - diagnosis Arrhythmias, Cardiac - therapy Child Equipment Design Heart Defects, Congenital - diagnosis Heart Defects, Congenital - therapy Humans Infant, Newborn Pacemaker, Artificial Prospective Studies Reproducibility of Results Retrospective Studies Treatment Outcome Young Adult
Transcatheter Leadless Pacemakers (TLP) are a safe and effective option for adults with pacing indications. These devices may be an alternative in pediatric patients and patients with congenital heart disease for whom repeated sternotomies, thoracotomies, or transvenous systems are unfavorable. However, exemption of children from clinical trials has created uncertainty over the indications, efficacy, and safety of TLP in the pediatric population. The objectives of this study are to evaluate clinical indications, procedural characteristics, electrical performance, and outcomes of TLP implantation in children. Retrospective data were collected from patients enrolled in the Pediatric and Congenital Electrophysiology Society TLP registry involving 15 centers. Patients ≤21 years of age who underwent Micra (Medtronic Inc, Minneapolis, MN) TLP implantation and had follow-up of ≥1 week were included in the study. The device was successfully implanted in 62 of 63 registry patients (98%) at a mean age of 15±4.1 years and included 20 (32%) patients with congenital heart disease. The mean body weight at TLP implantation was 55±19 kg and included 8 patients ≤8 years of age and ≤30 kg in weight. TLP was implanted by femoral (n=55, 87%) and internal jugular (n=8, 12.6%) venous approaches. During a mean follow-up period of 9.5±5.3 months, there were 10 (16%) complications including one cardiac perforation/pericardial effusion, one nonocclusive femoral venous thrombus, and one retrieval and replacement of TLP due to high thresholds. There were no deaths, TLP infections, or device embolizations. Electrical parameters, including capture thresholds, R wave sensing, and pacing impedances, remained stable. Initial results from the Pediatric and Congenital Electrophysiology Society TLP registry demonstrated a high level of successful Micra device implants via femoral and internal venous jugular approaches with stable electrical parameters and infrequent major complications. Long-term prospective data are needed to confirm the reproducibility of these initial findings.

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Collaboration types
Domestic collaboration
International collaboration
Web of Science research areas
Cardiac & Cardiovascular Systems
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