Journal article
Transcatheter Leadless Pacing in Children: A PACES Collaborative Study in the Real-World Setting
Circulation. Arrhythmia and electrophysiology, v 16(4), e011447
Apr 2023
PMID: 37039017
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
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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Details
- Title
- Transcatheter Leadless Pacing in Children: A PACES Collaborative Study in the Real-World Setting
- Creators
- Maully J Shah - Children's Hospital of PhiladelphiaAlejandro A Borquez - Rady Children's Hospital-San DiegoDaniel Cortez - University of MinnesotaAnthony C McCanta - Children's Hospital of Orange CountyPaolo De Filippo - Ospedale Papa Giovanni XXIIIRobert D Whitehill - Children's Healthcare of AtlantaJason R Imundo - Penn State Milton S. Hershey Medical CenterJeremy P Moore - Mattel Children's HospitalElizabeth D Sherwin - Children's NationalTaylor S Howard - Texas Children's HospitalEric Rosenthal - Evelina London Children's HealthcareNaomi J Kertesz - Nationwide Children's HospitalPhilip M Chang - UF Health Shands HospitalNandini Madan - Drexel UniversitySteven P Kutalek - Drexel UniversityBenjamin H Hammond - Cleveland Clinic Lerner College of MedicineChristopher M Janson - Children's Hospital of PhiladelphiaV Ramesh Iyer - University of PennsylvaniaMatthew R Williams - Rady Children's Hospital-San Diego
- Publication Details
- Circulation. Arrhythmia and electrophysiology, v 16(4), e011447
- Number of pages
- 13
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pediatrics; College of Medicine
- Web of Science ID
- WOS:000971842200003
- Scopus ID
- 2-s2.0-85152971080
- Other Identifier
- 991020431208904721
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- Collaboration types
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Cardiac & Cardiovascular Systems