IMPACT Registry Study Details Results and Safety of Common Congenital Interventional Procedures

A new registry-based report published Dec. 8 in the Journal of the American College of Cardiology described the results and safety of six common congenital interventional procedures – device closure of atrial septal defect (ASD), device closure of patent ductus arteriosus (PDA), pulmonary valvuloplasty, aortic valvuloplasty, Coarct angioplasty and stenting and pulmonary artery stenting – performed in patients enrolled in the ACC's IMPACT Registry during its initial data collection.

Overseen by principal author John Moore, MD, MPH, FACC, Division of Cardiology, Department of Pediatrics, Rady Children's Hospital, University of California San Diego, the study used data from patients enrolled in IMPACT Registry from January 2011 through March 2013. Results showed that from a total of 4,152 catheterizations, there were 1,286 single ASD procedures, 1,375 PDA procedures, 270 "typical" pulmonary valvuloplasty procedures, 305 aortic valve procedures, 671 aortic procedures, and 245 pulmonary artery procedures. Desired outcomes were accomplished in >98 percent of ASD and PDA procedures, but were less common in the others, with coarctation angioplasty procedures being the least successful (51 percent). Reports of major adverse event rates ranged from 0 percent to 3.3 percent. Total adverse event rates ranged from 5.3 percent to 24.3 percent.

The authors conclude that while longitudinal data is still needed to define the long-term effectiveness, safety and risk of mortality associated with interventional procedures in patients with congenital heart disease, the IMPACT Registry provides a proper source of measures and predictors of procedural success that may be considered in evaluating patients for common interventional procedures.

"The finding [of Moore et al.] may underwhelm the casual reader, but on further reflection, the serious reader will be impressed by the humility demonstrated in the pursuit of accuracy," writes Michael Landzberg, MD, FACC, Departments of Medicine and Cardiology, Brigham and Women's Hospital and Children's Hospital, Harvard Medical School, Boston, in a coinciding editorial. "Beginnings of procedural definitions emerged and patient and procedural characteristics are catalogued; significant limitations in these are recognized, allowing the Registry the ability to learn, reflect and to refine. The authors avoid terms such as 'success' related to procedure or outcomes, recognizing that the true, 2-fold triumph of these initial efforts: bringing together a congenital community that overwhelmingly endorsed participation in this Registry, and avoiding overstatement or over-interpretation of results. In so doing, Moore and colleagues, representing IMPACT Registry participants, confirm that the congenital cardiology field has matured and come of age, and can now can tackle some of its most difficult questions relating to outcomes, quality and worth ... The efforts of Moore and colleagues in this week's Journal, representing the steering committee and the many IMPACT participants, deserve praise. However, from these humble beginnings, great expectations remain. The stage has been clearly set for the future of congenital cardiology."

NCDR IMPACT Registry Moore JACC Safety of Common Interventional Procedures in CHD Study Slide

Keywords: Angioplasty, Aortic Coarctation, Aortic Valve, Catheterization, Registries, Ductus Arteriosus, Patent, Heart Defects, Congenital, Heart Septal Defects, Atrial, Pulmonary Artery

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