The Pediatric Heart Network Residual Lesion Score Study: Design and objectives.

Abstract

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 before discharge for residua). The multicenter prospective RLS study aims to analyze the influence 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 1 year postoperatively. The study cohort consisted of infants aged ≤12 months undergoing definitive surgery for complete atrioventricular septal defect, tetralogy of Fallot, dextro-transposition of the great arteries with or without intact ventricular septum, single ventricle (Norwood procedure), and coarctation or interrupted/hypoplastic arch with ventricular septal defect. Children with major congenital or acquired extracardiac anomalies that could independently affect the primary end point, which was number of days alive and out of the hospital within 30 days of surgery (60 days for Norwood procedure), were excluded. Secondary outcomes included ≥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. This is the first multicenter prospective validation of a tool for surgical outcome assessment and quality improvement specific to congenital heart surgery.