The IMPACT Registry: Improving Care and Tracking Outcomes for Patients with CHD

In this article EP Lab Digest speaks with Gerard R. Martin, MD, FACC, Chair of the NCDR^® IMPACT Registry Steering Committee. The IMPACT Registry™ is the first national registry designed to track outcomes for pediatric and adult patients undergoing a cardiac catheterization procedure for congenital heart disease. Dr. Martin is executive director of the Center for Heart, Lung and Kidney Disease at Children’s National Medical Center in Washington, DC. He is also co-director of the Children’s National Heart Institute, Washington, DC, and C. Richard Beyda Professor of Cardiology, George Washington University School of Medicine.

Describe the aim of the registry.

The purpose of the National Cardiovascular Data Registry’s (NCDR) IMPACT Registry™ (IMproving Pediatric and Adult Congenital Treatment) is primarily to improve patient care by promoting quality improvement at participating institutions. The registry will seek to assess the prevalence, demographics, management, and outcomes of patients undergoing diagnostic catheterization and catheter-based interventions for congenital heart disease (CHD). The collection and analysis of nationwide data will allow for significant contributions to the knowledge and outcomes associated with congenital heart disease. The data collected will facilitate performance measurement, benchmarking, and quality improvement for hospitals caring for patients with congenital heart disease.

When was it created? Why was there a need for this type of registry?

The interest to develop the IMPACT Registry began at an American College of Cardiology, Adult Congenital/Pediatric Cardiology Council breakout session on Quality Improvement. During this session, pediatric cardiologists and adult CHD cardiologists expressed their desire to establish a national registry to better understand clinical practice and patient outcomes. A workgroup was formed to write a concept and feasibility paper outlining the need and purpose of the registry. This paper was approved in August 2007, and a Steering Committee and Data Workgroup were then formed. The Steering Committee established the strategic direction and scope of the registry. The Data Workgroup was charged with selecting data elements and metrics for reporting. The Steering Committee also secured partnerships with key professional associations, including the Society for Cardiovascular Angiography and Interventions (SCAI), the Society of Thoracic Surgeons (STS), the American Academy of Pediatrics (AAP), and the Food and Drug Administration (FDA). 

Congenital heart disease is the most common type of birth defect. CHD also occurs in adults; recent epidemiological data have shown that the population of patients living with this disease is growing rapidly. It is now estimated that there are more adults than children in the United States with CHD. The number of adult CHD hospitalizations increased from approximately 36,000 to 73,000 over the period from 1998 to 2005. Improvements in medicine such as two-dimensional and color flow echocardiography, followed by novel surgical procedures, catheter-based interventions and intensive care treatment over the last 30 years, have resulted in an increasing number of pediatric CHD patients surviving into adulthood. It is estimated that 50% of pediatric patients diagnosed with CHD undergo corrective treatment in their first year of life. Results of surgical procedures are tracked in registries and have shown valuable trends in delivery of care. However, there are no such catheterization registries and, as a result, there has been inadequate monitoring of outcomes and procedural variability in the application of catheter-based interventions to the population as a whole. A catheterization registry to assess the quality and effectiveness of these procedures is needed.

How many institutions are currently participating in the registry? Do you anticipate expanding to additional centers?

The IMPACT Registry is open to all pediatric and adult centers. Presently, there are 23 centers submitting data to the registry.

What data is being collected in the IMPACT Registry?

The IMPACT Registry is set up in a similar manner as the other NCDR registries. There is a Demographics, Episode of Care, Congenital Conditions, Cath Lab Visit, Procedure Information, Hemodynamics, Intra- and Post-Procedure Events, and Discharge Information section. In addition to these sections, there are sections on Atrial Septal Defect (ASD), Coarctation of the Aorta (COA), Patent Ductus Arteriosus (PDA), Aortic Valvuloplasty, and Primary Pulmonary Artery Stenting.

Do you expect some variance in the data collected on the management and outcomes of pediatric and adult CHD patients?

Current published clinical practice guidelines have outlined recommendations for the care and management of CHD patients. However, for catheter-based interventional procedures and/or surgical treatments, most recommendations have been derived primarily from expert opinion, thereby underscoring the need to systematically collect data on these populations to gain greater evidence-based insights. In addition, because clinical studies conducted in congenital heart disease have generally been small in number, coupled with the fact that prior registries have been limited in scope and in geographic representation, there is a paucity of evidence-based information related to the use of diagnostic catheterization and catheter-based interventions, as well as the acute and long-term morbidity and mortality associated with these procedures. Along these same lines, there is an ongoing need to facilitate quality improvement in this area.

When will the first registry data be available?

The first Outcomes Report will be published to participating centers by the fourth quarter of 2011.

How can a hospital enroll in the registry?

To enroll in the IMPACT Registry, please contact Joan Michaels, BSN, MSN, associate director for the IMPACT Registry, at (202) 375-6309 for more information.

Tell about some of the recent support for the IMPACT Registry.

U.S. News and World Report recently added the IMPACT Registry to their questionnaire (e.g., “Does your hospital intend to participate in the IMPACT Registry?”) for the Best Children’s Hospital list.
In addition, the FDA has posted a letter to clinical investigators encouraging their support and participation in the IMPACT Registry; in the letter, Danica Marinac-Dabic, MD, PhD, Director, Division of Epidemiology, Center for Devices and Radiological Health, writes that participation in the registry will “provide significant contributions to the knowledge base and outcomes associated with congenital heart disease.”

Is there anything else you’d like to add?

I have thoroughly enjoyed chairing the steering committee and working with an incredibly talented group of interventional cardiologists who are passionate about improving the outcomes of their trade. I am confident that IMPACT will significantly change the way we care for our patients with congenital heart disease.

For more information, please visit: www.ncdr.com/impact 

References

1. Congenital Heart Defects. 16 June 2011. National Heart Lung and Blood Institute. <https://www.nhlbi.nih.gov/health/dci/Diseases/chd/chd_what.html>
2. Opotowsky AR, Siddiqi OK, Webb GD. Trends in hospitalizations for adults with congenital heart disease in the U.S. J Am Coll Cardiol 2009;54:460–467.