Surgery for congenital heart disease carries considerable risk for mortality. It is widely acknowledged that this risk varies significantly among congenital heart centers even after adjusting for known risk factors. A contemporary study from Pediatric Heart Network (PHN) centers demonstrated operative mortality rates that varied more than 3-fold among centers and even greater among surgeons. Collaborative efforts among adult heart surgery programs using the concepts of collaborative learning and standards development have markedly reduced practice variation and improved patient outcomes. By applying these same principles, this proposal endeavors to measure, analyze and improve outcomes for high-risk congenital heart surgery within the PHN. The study will focus on neonatal cardiac surgery which currently has a hospital mortality of greater than 10%. The investigators will employ a number of novel methodologies from the field of industrial engineering to measure various aspects of a center's performance including evaluation of protocols, direct observation of communication, and technical performance. Site evaluations and facilitation will be performed by a highly experienced team from the Georgia Institute of Technology. The study design will include measurement of surgical outcomes for neonatal heart surgery for a defined period. The cumulative sum control methodology (CUSUM), which represents the accumulated sum of all prior surgeries, comparing the actual to expected failure rate, will be used to measure outcomes. This aspect is especially important in congenital heart surgery, a complex and multi-faceted discipline whose volume cannot support the easy discovery of small effects. Each site and each surgeon will be evaluated with site- visits from a team of industrial engineers. These visits generate verbal and non-verbal communication, increasing the likelihood that unmeasured but important factors receive attention. Together through shared learning and consensus development of priority measures, each surgeon and center will institute a number of programatic changes. Subsequently outcomes will be reassessed to determine whether the failure rate has decreased significantly. The cumulative effect of several small changes may be impressive.

Public Health Relevance

There remains an unacceptable level of mortality and morbidity following newborn congenital heart surgery, with drastic variation among centers and surgeons. While randomized trials of novel peri-operative techniques may improve these outcomes to a small degree, strategies to identify best practices and reduce variability will more likely yield quantum improvements. This proposal endeavors to realize such improvements via collaboration, shared learning and application of industrial engineering principles.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
Application #
Study Section
Special Emphasis Panel (ZHL1-CSR-S (M2))
Program Officer
Pemberton, Victoria
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Emory University
Schools of Medicine
United States
Zip Code
Goldberg, David J; Zak, Victor; Goldstein, Bryan H et al. (2018) Design and rationale of the Fontan Udenafil Exercise Longitudinal (FUEL) trial. Am Heart J 201:1-8
Mahle, William T; Hu, Chenwei; Trachtenberg, Felicia et al. (2018) Heart failure after the Norwood procedure: An analysis of the Single Ventricle Reconstruction Trial. J Heart Lung Transplant 37:879-885
Saarel, Elizabeth V; Granger, Suzanne; Kaltman, Jonathan R et al. (2018) Electrocardiograms in Healthy North American Children in the Digital Age. Circ Arrhythm Electrophysiol 11:e005808
Minich, L LuAnn; Pemberton, Victoria L; Shekerdemian, Lara S et al. (2018) The Pediatric Heart Network Scholar Award programme: a unique mentored award embedded within a multicentre network. Cardiol Young 28:854-861
Mussatto, Kathleen A; Hollenbeck-Pringle, Danielle; Trachtenberg, Felicia et al. (2018) Utilisation of early intervention services in young children with hypoplastic left heart syndrome. Cardiol Young 28:126-133
Lopez, Leo; Colan, Steven; Stylianou, Mario et al. (2017) Relationship of Echocardiographic Z Scores Adjusted for Body Surface Area to Age, Sex, Race, and Ethnicity: The Pediatric Heart Network Normal Echocardiogram Database. Circ Cardiovasc Imaging 10:
Oster, Matthew E; Watkins, Stephanie; Hill, Kevin D et al. (2017) Academic Outcomes in Children With Congenital Heart Defects: A Population-Based Cohort Study. Circ Cardiovasc Qual Outcomes 10:
Oster, Matthew E; Chen, Shan; Dagincourt, Nicholas et al. (2017) Development and impact of arrhythmias after the Norwood procedure: A report from the Pediatric Heart Network. J Thorac Cardiovasc Surg 153:638-645.e2
Nathan, Meena; Jacobs, Marshall L; Gaynor, J William et al. (2017) Completeness and Accuracy of Local Clinical Registry Data for Children Undergoing Heart Surgery. Ann Thorac Surg 103:629-636
Mahle, William T; Nicolson, Susan C; Hollenbeck-Pringle, Danielle et al. (2016) Utilizing a Collaborative Learning Model to Promote Early Extubation Following Infant Heart Surgery. Pediatr Crit Care Med 17:939-947

Showing the most recent 10 out of 26 publications