IMPLANTABLE MEDICAL DEVICES USED IN THE CARE OF CHILDREN WITH CONGENITAL HEART DISEASE

Abstract:

Background While many FDA-approved valve replacements exist for adults, few have been developed for children, resulting in widespread adoption and off-label use of adult devices in even the youngest pediatric age groups. Improving our understanding of off-label device use in children will allow us to identify conditions and patient populations in greatest need of clinical innovation and research investment. Methods We identified valve implant procedures in children< 18 years from 1/1/2016 to 6/30/2022 in the STS-CHSD, a clinical registry of pediatric cardiac operations performed in North America. Medical device labels for each device were reviewed to ascertain if implanted valves were approved for pediatric use. Results We analyzed 9,897 valve implant procedures, with an average patient age of 8.6 (SD 5.9) years. A total of 11,197 valves were implanted, of which 1,041 (9%) were approved for pediatric use …