The study cohort included 9,608 valve implant procedures in 8,971 patients who were younger than 18 years (median age = 9 years; interquartile range = 2.7–14 years). The investigators identified a total of 10,875 valve devices implanted across these procedures. Each device was categorized based on FDA approval status: approved for pediatric use, approved for adults only, approved with unknown pediatric status, not approved for any population, or unknown approval status. Autografts and surgeon-fashioned valves were separately categorized because they fall outside FDA regulation.
According to the study published in JAMA Pediatrics, among all implanted devices, only 965 (8.9%) were FDA approved for pediatric use. In comparison, 6,716 devices (61.8%) were approved for adults only, 736 (6.8%) had unclear pediatric approval status, 1,076 (9.9%) were not FDA approved, and 392 (3.6%) had undetermined approval status. The devices represented 186 unique brand names, of which only eight (4.3%) were approved for pediatric patients, while 150 (80.6%) were approved for adults only. Use of pediatric-approved valves varied by age group: 20.7% of valves in infants were FDA approved for pediatric use, compared with 9.8% in children, 5.3% in neonates, and 2.9% in adolescents. The pulmonic and mitral valve positions had the highest frequency of pediatric-approved devices, accounting for 11.5% and 9.7%, respectively.
The researchers also noted that their findings may have underestimated off-label device use because they were not able to account for device implantation in unapproved locations.
The findings demonstrate a continued reliance on off-label use of adult cardiac valve devices in pediatric populations and reflect limited availability of FDA-approved, pediatric-specific devices, the investigators wrote.
No conflicts of interest were reported.
