Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures

The incidence of moderate to severe congenital heart disease (CHD) in the United States is estimated to be 6 per 1000 live-born full term infants. Recent advances in pediatric cardiology, surgery and critical care have significantly improved the survival rates of patients with CHD leading to an increase in prevalence in both children and adults. Children with CHD significant enough to require cardiac surgery frequently also undergo non-cardiac surgical procedures. Analysis of the Pediatric Health Information System database between 2004 and 2012 demonstrated that 41% of children who had undergone surgery to correct CHD in the first year of life also underwent at least one non-cardiac surgery by age 5. With this increased demand for non-cardiac procedures, anesthesiologists, pediatricians and other healthcare providers will encounter patients with repaired or unrepaired CHD and other cardiac diseases in their practice.

However, the information provided by national databases lack granularity and the information from single institutional data is limited.

This project aims to address this knowledge gap in quantifying the risk for cardiac patients coming for noncardiac procedures and identify the health care resource utilization and system to best care for this patient population. To conduct this study, we will create a multi-institutional collaboration between large and small centers to create a unique dataset spanning all the different variables that need to be considered in risk prediction for these patients including patient variables, hospital setting, and providers. The aggregate multiinstitutional data set may be used for benchmarking for national quality improvement efforts.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease in Children
• Intervention / Treatment: Other: No intervention. It is observational

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Viviane Nasr, MD; Phone Number: 617-355-6225; Email: viviane.nasr@childrens.harvard.edu
• Study Contact Backup: Name: Rachel Bernier; Phone Number: 857-218-5348; Email: Rachel.Bernier@childrens.harvard.edu

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Recruiting
      • Hospital for Sick Kids
      • Contact: Vannessa Chin, MD; Phone Number: 416-813-7445; Email: vannessa.chin@sickkids.ca
• United States
  • California
    • Los Angeles, California, United States, 90095
      • Active, not recruiting
      • University of California, Los Angeles
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20310
      • Recruiting
      • Children's National Medical Center
      • Contact: Nina Deutsch, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Active, not recruiting
      • Children's Healthcare of Atlanta - Egleston Hospita
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Viviane Nasr, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Active, not recruiting
      • University of Minnesota Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
      • Contact: Susan Nicolson
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Michael Kuntz, MD; Phone Number: 615-322-5000; Email: michael.kuntz@vumc.org
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Texas Children's Hospital
      • Contact: Wanda Miller Hance
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Terminated
      • Children's Hospital of The King's Daughter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with congenital heart disease and presenting to the participating institution for a noncardiac procedure are included in the study.

All patients will be included.

Description

Inclusion Criteria:

1. Males or females ages birth to 21 years.
2. Patients diagnosed with congenital heart disease
3. Patients undergoing a noncardiac procedure (surgical or nonsurgical)

Exclusion Criteria:

1. Patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers.
2. Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Death	during the procedure and up to 30-days following the procedure
Intensive Care Unit admission	The postoperative location of the patient is in the intensive care unit unexpectedly	following the procedure and up to 72 hours
Postoperative mechanical support	Patient required a ventilator or noninvasive positive pressure ventilation	following the procedure and up to 72 hours
Intraoperative cardiac event		During the perioperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission Cardiac arrest: during the procedure and up to 72 hours Neurologic injury (stroke, seizure) following the procedure and up to 72 hours Renal injury following the procedure and up to 72 hours	Patient was discharged after the procedure and needed to be readmitted to the hospital is defined as readmission	following the procedure and up to 72 hours
Cardiac arrest	Patient required cardiopulmonary ressuscitation	during the procedure and up to 72 hours
Neurologic injury	Defined as stroke or seizure by the provider	Following the procedure and up to 72 hours
Renal Injury	Defined based on creatinine and glomerular filtration	Following the procedure and up to 72 hours

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: The Hospital for Sick Children; Baylor College of Medicine; Children's Hospital of Philadelphia; University of California, Los Angeles; Vanderbilt University Medical Center; University of Minnesota; Children's National Research Institute; Children's Healthcare of Atlanta; Children's Hospital of The King's Daughters
• Investigators: Principal Investigator: Viviane Nasr, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Perioperative risk prediction; Adverse Postoperative Outcomes
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: IRB-P00035008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No