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Procedural Results and Safety of Common Interventional Procedures in Congenital Heart Disease: Initial Report From the National Cardiovascular Data Registry | Journal Scan
Study Questions:
What are the results of a large registry of congenital cardiac interventions?
Methods:
The Improving Pediatric and Adult Congenital Treatment (IMPACT) registry was developed by the National Cardiovascular Data Registry (NCDR). This study compiled registry data for patients enrolled in IMPACT from January 2011 through March 2013. Patients were included if they underwent an isolated interventional procedure, including device closure of atrial septal defect (ASD), device closure of patent ductus arteriosus (PDA), pulmonary valvuloplasty, aortic valvuloplasty, coarctation of the aorta angioplasty and stenting, and pulmonary artery (PA) stenting. Patient data, procedural data and results, and adverse events (AEs) were reviewed and described. Major adverse events (MAEs) were defined as: need for permanent or temporary pacemaker, cardiac arrest, cardiac tamponade requiring drainage, embolic stroke within 72 hours of procedure, and unplanned cardiac surgery due to catheterization complication.
Results:
For the 1,286 ASD closures, AEs occurred in 5.7% of patients, with MAEs in 1.2% of patients. For 1,375 PDA procedures, AEs occurred in 5.3% of patients, with MAEs in 0.2%. Device embolization occurred in 1.2% of cases, with successful catheter retrieval in 69%. There were 270 “typical” pulmonary valve procedures, with AEs in 7.1% of patients (mostly infants), and no MAEs. Pulmonary valve insufficiency ≥2+ was observed in <10% of cases. Single-balloon aortic valvuloplasty was reported in 305 patients, with AEs in 24.3% and MAEs in 3.3%. Aortic insufficiency of 2+ was seen in 15.1% of patients, whereas aortic insufficiency of >2+ was seen in 2.3% of patients. Balloon dilatation and/or stenting of coarctation of the aorta were reported in 671 patients, with 17.3% AEs and 1.2% MAEs. Stent implantation for proximal PA stenosis was reported in 245 patients with biventricular physiology. AEs were reported in 13.2% of patients, with MAEs occurring in 1.2%.
Conclusions:
This report describes the contemporary community practice, procedural outcomes, and safety for six common congenital cardiac interventional procedures, which provides benchmark data for historical and future comparisons.
Perspective:
This data-laden report is not conducive to a brief summary of results. The manuscript contains an enormous amount of data related to congenital cardiac interventions, and demonstrates the power of a large, coordinated registry. The data set will allow for individual centers to compare themselves with national benchmarks. The primary limitation of the registry is that the data are self-reported, with the possibility of reporting bias or incomplete data. An auditing procedure for the IMPACT registry is under development, but was not in place for the data reported in this manuscript. Despite these limitations, the IMPACT registry provides important benchmark data for congenital cardiac interventions.
Keywords: Angioplasty, Aortic Coarctation, Aortic Valve Insufficiency, Cardiac Surgical Procedures, Cardiac Tamponade, Cardiac Catheterization, Constriction, Pathologic, Dilatation, Ductus Arteriosus, Heart Arrest, Heart Defects, Congenital, Heart Septal Defects, Atrial, Infant, Pulmonary Artery, Pulmonary Valve, Stents, Stroke
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