Development of the MAGIC Congenital Heart Disease Catheterization Database for Interventional Outcome Studies

Abstract

As the field of catheter-based therapies for congenital heart disease continues to expand, we lack the evidence-based data to make appropriate therapeutic decisions in the catheterization laboratory. A stumbling block to the determination of evidence-based therapies is our inability to simply and reliably share outcome data across multiple centers. We investigated whether a commonly used congenital heart disease catheterization database program (PedCath) could be used as an automatic catheterization data submission tool to a central database for outcome analysis. To test the feasibility of such a tool for collaborative outcomes research we formed a national group of seven congenital heart disease centers, the Mid-Atlantic Group of Interventional Cardiology, to warehouse and analyze catheterization data. We successfully modified PedCath to transfer the results of catheter-based therapies on 256 therapeutic procedures for atrial septal defect (ASD) closure, coarctation of the aorta angioplasty and stenting, and pulmonary and aortic balloon valvuloplasties over a 13-month pilot period. Short-term follow-up within the 13-month period was received on 31 patients. This study demonstrated the successful development of a simple process, requiring minimal data entry for investigators from around the world to share cardiac catheterization data for long-term outcome determination of catheter-based therapies for congenital heart disease.

Catheterization for Congenital Heart Disease Adjustment for Risk Method (CHARM)

“…Currently, there are several groups gathering this type of data, including C3PO, the MAGIC (MidAtlantic Group of Interventional Cardiology), and the CCISC (Congenital Cardiovascular Interventional Study Consortium), but these efforts have been relatively recent and there is limited ability to cross-communicate between the systems (8,(21)(22)(23). There is an effort to make a more widely used outcomes registry through the American College of Cardiology IMPACT (Improving Pediatric Adult Congenital Treatments) registry, which began in 2011 (24).…”

Procedural characteristics and adverse events in diagnostic and interventional catheterisations in paediatric and adult CHD: initial report from the IMPACT Registry

“…Previous congenital cardiac databases have concentrated mainly on interventional procedures. [1][2][3][4][5][6][7][8] In its design, the IMPACT Registry aims to collect catheterisation data on all children and adult congenital cases, including all diagnostic, biopsy, and interventional procedures. More in-depth data were obtained on the following six specific interventions: device closure of atrial septal defect; device closure of patent ductus arteriosus; pulmonary valvuloplasty for pulmonary stenosis; aortic valvuloplasty for aortic stenosis; interventionsangioplasty and stentingon coarctation of the aorta; and central pulmonary artery stenting.…”

Balloon valvuloplasty for congenital aortic stenosis: Multi‐center safety and efficacy outcome assessment

“…Data collection and reporting methodologies used within C3PO and MAGIC have been previously reported . Institutional Review Board approval was obtained at all sites.…”

“…The Congenital Cardiac Catheterization Outcome Project (C3PO) and the Mid‐Atlantic Group of Interventional Cardiology (MAGIC) collected data on diagnostic and interventional catheterization procedures performed in patients with congenital heart disease at 22 centers (Appendix Table ). We examined the prospectively‐collected data on BAVP for cAS from these two registries to assess the procedural efficacy and to estimate adverse event rates in the current era.…”