The use of a stent to repair pulmonary artery stenosis in children and adults with congenital heart disease was successful in the majority of patients, but many also experienced serious complications, according to a study published March 14 in the Journal of the American College of Cardiology.

Using data from ACC’s IMPACT Registry, researchers examined records from 1,183 patients treated at 59 U.S. hospitals between January 2011 and January 2014. Of that group, 262 patients had a single ventricle.

For patients with two ventricles, researchers developed two definitions to measure success, each with separate benchmarks. Both definitions looked at whether pressure in the right ventricle decreased and the diameter of the pulmonary artery increased following the procedure. The second definition included an additional measurement – whether the pressure across the obstructed vessel changed, and by how much. 

Researchers found that when using the first definition, 76 percent of the procedures were considered successful, while 86 percent based on the second definition were deemed a success. The overall success rate was more than 75 percent.

For single ventricle patients, researchers used an increase in the diameter of the pulmonary artery after stenting as the definition for success. Among those procedures, 75 percent were considered successful. The complication rate for all patients in the study cohort was 14 percent, with 9 percent experiencing death or a major adverse event, often associated with bleeding. Patients with a single ventricle were 2.3 times more likely to have a major adverse event than those with two ventricles.   

Matthew J. Lewis, MD, MPH, the study’s lead author said that “given the high rate of adverse events, further study is needed to determine how to minimize patient risk and further validate definitions of procedural success.”

In an accompanying editorial, Phillip Moore, MD, MBA, FACC, adds that because the two definitions of success resulted in statistically significant different rates, there is a need for a clear, widely agreed upon definition of procedural success so that “we can begin to reap the true potential benefits of our ‘big data’ efforts.”  

Keywords: Benchmarking, Child, Cohort Studies, Constriction, Pathologic, Heart Defects, Congenital, Heart Ventricles, Pulmonary Artery, Pulmonary Circulation, Pulmonary Valve Stenosis, Registries, Stents, IMPACT Registry, National Cardiovascular Data Registries

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