New Registry Studying Long-Term Outcomes of Heart Procedures

A new national registry is tracking patients’ progress over time following heart procedures as neonates.

Children’s of Alabama has joined a new national registry managed by the Congenital Cardiac Research Collaborative (CCRC), attempting to answer the question: What is the best way to treat ductal-dependent pulmonary blood flow congenital heart conditions?

Conditions such as Tetralogy of Fallot, critical pulmonary valve stenosis and complex single-ventricle arrangements can be treated with various interventions, both percutaneous and surgical. “We’re looking at all neonates (first 30 days of life) who require a procedure, so they get enough pulmonary blood flow to survive,” Children’s pediatric cardiologist Mark Law, M.D., said. “The goal is to take this broad grouping of patients and understand how they do, not just with their first intervention or even their second intervention if they need one, but how do they do as they grow up?” This question of long-term outcomes hasn’t been studied, he said.

“In our field, we tend to be very focused on the short-term, procedural outcome. We have a disease, we have a problem. We do an intervention, and we look at that intervention or outcome. But we haven’t looked at overall survival and longevity; some of the more nuanced outcomes, including quality of life,” Law said.

The idea came about as the result of the Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (COMPASS) trial, which is comparing overall survival and post-surgical complications, hospital length of stay and quality of life between a surgically inserted shunt and one threaded into the ductus arteriosus, the artery that connects the aorta and pulmonary artery in newborns. That trial, in which Children’s is also participating, will follow patients for two years. Part of the funding enabled the development of the registry. Participation requirements for the registry are also broader than for the clinical trial, opening it up to a larger population. It will also be part of Cardiac Networks United, which manages numerous other registries.

The CCRC registry, which currently has 14 participating institutions, started in 2022 and has been collecting data for less than a year. Children’s was among the first institutions to join. The registry will track how patients fare over time and provide valuable information about which treatment pathway is best for which condition and which child. Children’s has been enrolling patients since October 2022 and currently has about 11. The goal is 15 to 20 a year. Registry information on each participant will be updated annually, but Law said that’s one of the challenging parts of the study—for instance, if families move out of the area and are seen at other institutions. That challenge, Law said, could be overcome through the robust electronic health records children’s hospitals use to share information.

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