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Current Device Needs for Patients with Pediatric and Congenital Heart Disease

Heather M Giacone1, Anne M Dubin1

  • 1Department of Pediatric Cardiology, Lucile Packard Children's Hospital at Stanford University, 750 Welch Road, Palo Alto, CA 94304, USA.

Cardiac Electrophysiology Clinics
|October 21, 2023
PubMed

Insights

Pediatric electrophysiologists lack specialized cardiac implantable electronic devices (CIEDs) for children, leading to higher complication rates. Improved regulations and clinical trial support are emerging for pediatric and congenital heart disease patients needing CIEDs.

Area of Science:

  • Pediatric Cardiology
  • Biomedical Engineering
  • Medical Device Regulation

Background:

  • Pediatric electrophysiologists face a shortage of cardiac implantable electronic devices (CIEDs) specifically designed for children.
  • Unique pediatric patient characteristics, including vascular and anatomical differences and growth potential, restrict available CIED options.
  • Pediatric and congenital heart disease (CHD) patients experience higher rates of CIED-related complications than adult populations.

Purpose of the Study:

  • To highlight the challenges in pediatric CIED implantation.
  • To emphasize the need for pediatric-specific device development and advocacy.
  • To discuss the progress in regulatory improvements and clinical trial support for pediatric CIEDs.

Main Methods:

  • Literature review and expert opinion synthesis regarding pediatric CIED challenges.
  • Analysis of patient-specific factors influencing device selection and outcomes.
  • Examination of collaborative efforts between regulatory bodies, industry, and medical societies.

Main Results:

  • A significant deficit in pediatric-appropriate CIEDs exists, impacting patient care.
  • Pediatric and CHD patients exhibit increased risks for CIED-related complications.
  • Collaborative initiatives have enhanced regulatory frameworks and facilitated clinical trials for pediatric devices.

Conclusions:

  • Addressing the paucity of pediatric CIEDs is crucial for improving patient outcomes.
  • Continued collaboration is essential for advancing device innovation and ensuring patient safety.
  • Regulatory advancements and trial support are vital for meeting the growing needs of pediatric patients requiring CIEDs.

Keywords:
Congenital heart diseaseFDAPacemakerPediatric devices

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