Design and Objectives of the Pediatric Heart Network’s Residual Lesion Score Study

Abstract Objectives The Residual Lesion Score (RLS) was developed as a novel tool for assessing residual lesions after congenital heart operations based on widely available clinical and echocardiographic characteristics. The RLS ranks postoperative findings as follows: Class 1 (no/trivial residua), Class 2 (minor residua), or Class 3 (major residua or reintervention prior to discharge for residua). The multi-center prospective RLS study aims to analyze the impact of residual lesions on outcomes in common congenital cardiac operations. We hypothesize that RLS will predict postoperative adverse events, resource utilization, mortality and reinterventions by one year postoperatively. Methods The study cohort consists of infants ≤12 months of age undergoing definitive surgery for: (1) complete atrioventricular septal defect, (2) tetralogy of Fallot, (3) dextro-transposition of the great arteries with or without intact ventricular septum, (4) single ventricle (Norwood procedure), and (5) coarctation or interrupted/hypoplastic arch with ventricular septal defect. Subjects with major congenital or acquired extra-cardiac anomalies that could independently affect the primary endpoint, which is number of days alive and out of the hospital within 30 days of surgery (60 days for Norwood procedure), were excluded. Secondary outcomes include: ≥1 early major postoperative adverse event; days of intensive care unit and hospital stay, and initial and total ventilator time; mortality/transplant after discharge; unplanned reinterventions after discharge; and cost. All analyses will be performed separately by surgical operation. Conclusion This is the first multi-center prospective validation of a tool for surgical outcome assessment and quality improvement specific to congenital heart surgery.