The aim of this research is to study whether a scoring system called the Residual Lesion Score will predict how children with congenital heart disease do after cardiac surgery. We hope the scoring system will help doctors and nurses understand which parts of cardiac surgery may affect a child’s recovery after surgery.
The study began in the summer of 2015 and was completed at seventeen Pediatric Heart Network centers in the United States and Canada. 1149 patients across the centers were enrolled in this study. Some data elements for this study were collected from a surgical database to compare how accurate data can be from electronic sources.
1149 patients were enrolled in this study.
Seventeen PHN research centers participated in this study.
Suggesting that registry data can be an efficient source for research studies.
For each child who participated in this study, we recorded information about the child’s medical history, cardiac surgery and post-operative recovery, including the child’s echocardiograms (ultrasound examination of the heart) performed for his or her routine care around the time of surgery. We also contacted families one year after their child’s surgery to ask about any medical or surgical procedures that may have occurred after the child’s hospital discharge.
Results of this study are currently being analyzed. The PHN is grateful to all of the families who participated in this study.
M. Nathan, Ann Thorac Surg 2016 Oct 7. pii: S0003-4975(16)30916-X.
The purpose of this study was to assess the accuracy of heart surgery data obtained from a registry compared with data copied from babies’ medical charts by research coordinators. Most PHN sites participate in a registry called “the Society of Thoracic Surgeons- Congenital Heart Surgery Database” in which each site collects data around the time of surgeries. For a select set of variables (like blood pressure, length of hospital stay etc), we found that 94.7% of data elements were both complete and accurate within the registry, suggesting that registry data can be an efficient source for research studies.
M. Nathan, J Thorac Cardiovasc Surg 2019 Nov 15. pii: S0022-5223(19)32761-8.
Outcomes after surgery for congenital heart disease may be impacted by a wide variety of variables. Risk for adverse outcomes begins before surgery and includes innate characteristics such as birth weight, gestational age, genetic abnormalities, and complexity of congenital heart disease (CHD), as well as factors such as hemodynamic stability, adequacy of diagnostic evaluation, prior cardiac operation(s), and appropriateness of surgical plan. Intraoperative risk factors relate to cardiopulmonary bypass, surgical technique, adequacy of intraoperative imaging, subsequent decision to return (or not) to bypass for residual lesions identified, and early post-bypass hemodynamic management. The postoperative milieu may also contribute to outcomes, particularly through serious medical events and complications. The presence of residual lesions (intended or unintended postoperative structural cardiac abnormalities, including those persisting from the preoperative state or newly acquired consequent to the surgical procedure) may be among the most important factors in determining long-term clinical outcomes and costs. The “Residual Lesion Score” (RLS) is a novel tool for evaluating the status of repair across operations and centers. The prospective multi-center RLS study, funded by the National Heart Lung and Blood Institute’s Pediatric Heart Network (PHN), seeks to validate the association of the RLS with early and mid-term postoperative outcomes for common congenital cardiac operations in a multicenter environment. The RLS can serve as an instrument for quality improvement and support future research on perioperative strategies to improve outcomes of congenital heart surgery.
C. J. Prospero, Cardiol Young. 2019 Jul;29(7):930-938.
B. R. Anderson, Cardiol Young. 2020 Jun;30(6):807-817.
J. C. Levine, Cardiol Young 2024 Mar: 34(3)570-575.
This was a descriptive paper outlining our challenges and solutions and was designed to help others who may wish to carry out similar projects. This study reviewed some of the unique considerations related to planning and executing the review of echocardiographic images in the Residual Lesion Score study when the participants are in the infant age range. These unique considerations included those related to imaging of patients who may not be able to cooperate with data acquisition, imaging of patients with complex anatomic variants and coordinating uniform data collection across a large number of centers with variable imaging requirements and styles. Finally, we reviewed the lack of technical infrastructure that currently exists to support this type of data review and the efforts that we went through to modify existing platforms and create some unique software.
M. Nathan, Cardiol Young 2022 Dec 23: 1-14.
The Pediatric Heart Network conducted a study to test a new tool called the Residual Lesion Score. This tool helps doctors assess if there are any remaining heart defects after surgery for congenital heart defects. It uses ultrasound images called echocardiograms and also considers if any unexpected additional procedures were needed after the initial heart surgery before the child leaves the hospital.
The Residual Lesion Score was developed based on a previous tool called the Technical Performance Score. Experts used the RAND Delphi methodology to refine the Technical Performance Score to develop the Residual Lesion Score. This method involves rating the quality of different measures on a nine-point scale, where higher numbers indicate better quality. The scale helps ensure that the ratings are fair and not influenced by dominant voices in the group.
A panel of 11 experts in pediatric heart care, under the guidance of experts, reviewed and provided feedback on the Residual Lesion Score. They looked at its validity (how well does it measures what it is supposed to) and feasibility (how practical is it to use) for five common heart surgeries in infants. These surgeries include:
1. Repair of tetralogy of Fallot with pulmonary stenosis
2. Repair of complete atrioventricular septal defect
3. Arterial switch operation for dextro-transposition of the great arteries
4. Repair of coarctation of the aorta or related conditions
5. Norwood procedure for single ventricle anatomy
The experts first reviewed the tool via email and then met in person to discuss and refine it. Based on analysis of the final validity and feasibility scores from experts, we developed the final Residual Lesion Score for each of these surgeries. These scores were then tested in the Pediatric Heart Network’s Residual Lesion Score study.