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 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. Methods: 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. Conclusions: This is the first multicenter prospective validation of a tool for surgical outcome assessment and quality improvement specific to congenital heart surgery.
Bibliographical noteFunding Information:
Authors have nothing to disclose with regard to commercial support. The authors thank the registry data managers from each site and the software vendors, particularly Owen White, who graciously volunteered their time to develop queries for extracting registry data for the Residual Lesion Score Study. The authors also thank the study coordinators from each of the 17 sites for their invaluable contribution to this study ( Appendix E1 ). Pediatric Heart Network's Residual Lesion Score Writing Committee: Meena Nathan MD, MPH (Department of Cardiac Surgery, Boston Children's Hospital); Felicia L. Trachtenberg, PhD, and Maria I. Van Rompay, PhD (New England Research Institutes, Inc); William Gaynor, MD (Division of Cardiac Surgery, Children's Hospital of Philadelphia); Kirk Kanter, MD (Division of Pediatric Cardiac Surgery, Children's Health Care of Atlanta); Richard Ohye, MD (Division of Pediatric Cardiac Surgery, C. S. Mott Children's Hospital); Emile A. Bacha, MD (Division of Cardiothoracic Surgery, New York Presbyterian/Morgan Stanley Children's Hospital, Columbia University Irving Medical Center); James Tweddell, MD (Division of Pediatric Cardiac Surgery, Cincinnati Children's Hospital and Medical Center); Steven M. Schwartz, MD (Division of Cardiac Critical Care Medicine, The Hospital for Sick Children); L. LuAnn Minich, MD, and Linda M. Lambert, MSN-FNP (Division of Pediatric Cardiology, University of Utah and Primary Children's Hospital); Carlos M. Mery, MD, MPH (Texas Center for Pediatric and Congenital Heart Disease, University of Texas Dell Medical School/Dell Children's Medical Center); Christian Pizarro, MD (Division of Cardiac Surgery, Nemours Cardiac Center, Alfred I. duPont Hospital for Children); Steven D. Colan, MD, Jami Levine, MD, and Carolyn Dunbar-Masterson, MSN (Department of Cardiology, Boston Children's Hospital); Brett R. Anderson, MD, MBA, MS (Division of Pediatric Cardiology, New York-Presbyterian/Morgan Stanley Children's Hospital, Columbia University Irving Medical Center); Eric M. Graham, MD (Division of Pediatric Cardiology, Medical University of South Carolina); Geetha Raghuveer MD (Heart Center, Children's Mercy Hospital); Marcus S. Schamberger, MD (Division of Pediatric Cardiology, Riley Hospital for Children); Jonathan R. Kaltman, MD (Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute); Benjamin Goot, MD (Division of Pediatric Cardiology, Children's Hospital of Wisconsin, Medical College of Wisconsin); Shanthi Sivanandam, MD (Division of Pediatric Cardiology, Masonic Children's Hospital); David M. Overman, MD (Division of Cardiovascular Surgery, Children's Hospitals and Clinics of Minnesota); Marshall L. Jacobs, MD (Department of Surgery, Johns Hopkins School of Medicine); Jeffrey P. Jacobs, MD (Division of Cardiac Surgery, Johns Hopkins Heart and Vascular Institute); Iki Adachi, MD (Division of Congenital Heart Surgery, Texas Children's Hospital); Nicolas Madsen, MD (Division of Pediatric Cardiology, Cincinnati Children's Hospital and Medical Center); and Jane W. Newburger, MD, MPH (Department of Cardiology, Boston Children's Hospital).
- congenital heart surgery, Residual Lesion Score, outcomes