A recent meeting of the International Society for Heart and Lung Transplantation (ISHLT) highlighted the need to improve pediatric heart devices for children with life-threatening heart conditions. The current landscape favors adult devices, forcing clinicians to adapt them for pediatric patients, leading to suboptimal care and higher risks.

Critical Gaps in Patient Care

Pediatric patients with advanced heart failure often need mechanical circulatory support (MCS) devices while awaiting heart transplantation. However, most devices are designed for adults, leaving a significant gap in safe pediatric heart devices. This lack of specialized options heightens risks and complicates care. The small pediatric population reduces industry incentives to invest in device development due to concerns over return on investment. Consequently, children often receive off-label adult MCS devices, which can cause complications.

Progress and Challenges in Pediatric Cardiac Care

Recent years have seen improvements in pediatric end-stage heart failure management. Over a third of pediatric heart transplant recipients are now bridged to transplantation with a VAD, and waitlist mortality has halved since these devices became more common.

While the FDA has approved some pediatric-specific devices—like the Berlin Heart EXCOR VAD—most options remain oversized or poorly suited for children. The CDC reports that about 40,000 U.S. children are born yearly with congenital heart defects, highlighting the need for better pediatric heart devices. Initiatives like ACTION are pushing for more child-specific devices and expanded labeling.

Economic Implications and Accessibility

• Health Economics and Outcomes Research: The lack of pediatric-specific heart devices leads to complications, longer hospital stays, and higher costs. Tailored devices could improve outcomes and reduce expenses.
• Market Access and Pricing: The small patient population discourages manufacturers, limiting innovation and availability.
• Reimbursement Issues: Payers may refuse to cover off-label or poorly studied pediatric devices. Expanding FDA labeling and trials could improve reimbursement and industry engagement.
• Collaborative Efforts Needed: Ongoing initiatives, sometimes with FDA support, are addressing pediatric heart devices, but gaps remain. Clinicians, industry professionals, regulators, and advocates must collaborate to improve care for children with severe cardiac conditions.

Bridging the Gap

The ISHLT experts highlight a critical gap in the pediatric heart devices market. Underfunding, weak industry incentives, and reliance on adult devices worsen the problem. Innovation, policy changes, and collaboration could improve outcomes and create a more efficient healthcare system.