NEST R2: Characterization and Utilization of Therapeutic Cardiac Devices in Children with Congenital Heart Disease

Utilizing the Electronic Health Record (EHR) to capture the use of implantable devices during congenital cardiac catheterization procedures across multiple institutions has not been previously possible. In this Test Case sponsored by the National Evaluation System for Health Technology Coordinating Center (NESTcc), we aimed to use the amalgamated EHR of a consortium of pediatric hospitals included within the PEDSnet learning health system to track the specifics of device implantation with unique device identifiers (UDI) in the pulmonary and systemic arteries and veins during cardiac catheterization interventions. The initial medical device of interest was the range of Cook Formula 418® Pre-Mounted Stents, currently used “off-label” in this population. These stents are of particular interest in the pediatric age as they are pre-mounted, have low profile, excellent radial strength and expandability. Considering the real-world experience / evidence (RWE), the aim was expanded to characterize the range of all pediatric stent use throughout the cardiac space (vascular and intra-cardiac) at participating PEDSnet sites. This Test Case was successful in demonstrating that with substantial human commitment and system adjustment, UDI’s were successfully tracked within discrete populations across multiple institutions. Real-time adjustment of the secondary aims leveraged greater specificity of the site of device implantation and additional patient level clinical information. This successful demonstration may allow development of a scalable approach to investigating any UDI coded devices across multiple institutions. Multi-institutional implantation and use surveillance could provide the impetus for more robust outcome assessment, and possible label expansion.