Residual Lesion Score (RLS)

(Observational Study)

Study Summary

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

1149 patients were enrolled in this study.

17 Centers

Seventeen PHN research centers participated in this study.

94.7% of Data Elements Complete and Accurate

Suggesting that registry data can be an efficient source for research studies.

Who was in the study?

This study enrolled children less than one year old who were undergoing one of the following cardiac surgeries:
  1. Repair of complete common atrioventricular canal;
  2. Repair of Tetralogy of Fallot with pulmonary stenosis;
  3. Repair of arterial switch operation;
  4. Stage I Norwood procedure; or
  5. Repair of interrupted/hypoplastic arch or coarctation with VSD closure.

What happened during the study?

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.

What were the results of the study?

Results of this study are currently being analyzed. The PHN is grateful to all of the families who participated in this study.

Study Publications

  • Completeness and Accuracy of Local Clinical Registry Data for Children Undergoing Heart Surgery

    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.

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  • The Pediatric Heart Network Residual Lesion Score Study: Design and Objectives

    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.

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  • Lessons learned in the use of clinical registry data in a multi-centre prospective study: the Pediatric Heart Network Residual Lesion Score Study

    C. J. Prospero, Cardiol Young. 2019 Jul;29(7):930-938.

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  • Registry-based trials: a potential model for cost savings?

    B. R. Anderson, Cardiol Young. 2020 Jun;30(6):807-817.

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