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Echocardiographic image collection and evaluation in infants with CHD: lessons learned from the imaging core lab for the Residual Lesion Score study

Published online by Cambridge University Press:  22 August 2023

Jami C. Levine Open the ORCID record for Jami C. Levine [Opens in a new window] ,
Steven Colan ,
Felicia Trachtenberg ,
Edward Marcus ,
Matthew Ferguson ,
Anitha Parthiban ,
Carolyn Taylor ,
Andreea Dragulescu ,
Benjamin Goot Open the ORCID record for Benjamin Goot [Opens in a new window]  and
Ronald V. Lacro
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Jami C. Levine*
Affiliation:
Department Cardiology, Boston Children’s Hospital, Harvard Medical School, Boston, MA, USA
Steven Colan
Affiliation:
Department Cardiology, Boston Children’s Hospital, Harvard Medical School, Boston, MA, USA
Felicia Trachtenberg
Affiliation:
Healthcore, Watertown, MA, USA
Edward Marcus
Affiliation:
Department Cardiology, Boston Children’s Hospital, Harvard Medical School, Boston, MA, USA
Matthew Ferguson
Affiliation:
Department of Pediatrics, Emory University School of Medicine, Atlanta, GA, USA
Anitha Parthiban
Affiliation:
Department of Pediatrics, Texas Children’s Hospital, Baylor College of Medicine, Houston, TX, USA
Carolyn Taylor
Affiliation:
Department of Pediatrics, Medical University of South Carolina Children’s Hospital, Charleston, SC, USA
Andreea Dragulescu
Affiliation:
Department of Paediatrics, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada
Benjamin Goot
Affiliation:
Department of Pediatrics, Children’s Wisconsin, Medical College of Wisconsin, Milwaukee, WI, USA
Ronald V. Lacro
Affiliation:
Department Cardiology, Boston Children’s Hospital, Boston, MA, USA
Carol McFarland
Affiliation:
Department of Pediatrics, Primary Children’s Hospital, University of Utah, Salt Lake City, UT, USA
Shanthi Narasimhan
Affiliation:
Department of Pediatric Cardiology, Masonic Children’s Hospital, University of Minnesota, Minneapolis, MN, USA
Matthew O’Connor
Affiliation:
Department of Pediatrics, Children’s Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, USA
Marcus Schamberger
Affiliation:
Department of Pediatrics, Riley Children’s Hospital, Indiana University School of Medicine, Indianapolis, IN, USA
Shubhika Srivistava
Affiliation:
Department of Pediatrics, Nemours/Alfred I. DuPont Hospital for Children, Wilmington, DE, USA
Michael Taylor
Affiliation:
Department of Pediatrics, Cincinnati Children’s Medical Center, University of Cincinnati, Cincinnati, OH, USA
Meena Nathan
Affiliation:
Department Cardiology, Boston Children’s Hospital, Harvard Medical School, Boston, MA, USA
*
Corresponding author: Jami C. Levine; Email: Jami.levine@cardio.chboston.org
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Abstract

Many factors affect patient outcome after congenital heart surgery, including the complexity of the heart disease, pre-operative status, patient specific factors (prematurity, nutritional status and/or presence of comorbid conditions or genetic syndromes), and post-operative residual lesions. The Residual Lesion Score is a novel tool for assessing whether specific residual cardiac lesions after surgery have a measurable impact on outcome. The goal is to understand which residual lesions can be tolerated and which should be addressed prior to leaving the operating room. The Residual Lesion Score study is a large multicentre prospective study designed to evaluate the association of Residual Lesion Score to outcomes in infants undergoing surgery for CHD. This Pediatric Heart Network and National Heart, Lung, and Blood Institute-funded study prospectively enrolled 1,149 infants undergoing 5 different congenital cardiac surgical repairs at 17 surgical centres. Given the contribution of echocardiographic measurements in assigning the Residual Lesion Score, the Residual Lesion Score study made use of a centralised core lab in addition to site review of all data. The data collection plan was designed with the added goal of collecting image quality information in a way that would permit us to improve our understanding of the reproducibility, variability, and feasibility of the echocardiographic measurements being made. There were significant challenges along the way, including the coordination, de-identification, storage, and interpretation of very large quantities of imaging data. This necessitated the development of new infrastructure and technology, as well as use of novel statistical methods. The study was successfully completed, but the size and complexity of the population being studied and the data being extracted required more technologic and human resources than expected which impacted the length and cost of conducting the study. This paper outlines the process of designing and executing this complex protocol, some of the barriers to implementation and lessons to be considered in the design of future studies.

Keywords

Paediatric cardiologycongenital heart surgeryechocardiographymulticentre trial
Type
Original Article
Information
Cardiology in the Young , Volume 34 , Issue 3 , March 2024 , pp. 570 - 575
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Copyright
© The Author(s), 2023. Published by Cambridge University Press

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