COVID-19 Pediatric Patients with Congenital Heart Disease in the US: Characterizing Clinical Impact, Outcomes, and Current Pandemic Response to Inform Future Crisis Preparedness

This proposal has three specific aims designed to provide critical information about the impact and scope of the COVID-19 pandemic among patients less than age 30 years with congenital heart disease (CHD), derive empirically-based criteria to stratify COVID-19 severity risk among this population, provide data around patient triage, and formulate policy that will inform future responses to this and similar crises from a personnel, individual hospital, and regional healthcare delivery perspective.

AIM 1 focuses on the impact of COVID-19 on clinical presentations and outcomes
AIM 1a: Characterize differences in the clinical profiles among COVID-19 positive pediatric patients with CHD versus a contemporaneous cohort of COVID-19 negative patients with CHD.
Aim1b: Characterize differences in the clinical profiles among COVID-19 positive pediatric patients without CHD versus a contemporaneous cohort of COVID-19 positive patients with CHD.
AIM1c: Examine the impact of COVID-19 positive status on outcomes after interventional procedures. In-hospital outcomes after cardiac catheterization and surgical procedures among CHD patients will be compared to risk-adjusted outcomes from contemporaneous registry data. Outcomes include: Major morbidity (using Society of Thoracic Surgeons Congenital Heart Surgery Database [STS-CHSD] definitions), length of hospital stay, level and duration of respiratory support, and hospital billed charges and cost).

AIM2 focuses on the national scope, variation, and impact of current pandemic response systems and decision-making processes
Aim 2a: Describe the evolution of response systems utilized at congenital cardiac surgery programs during the COVID-19 pandemic. Changes in policy will be tracked at the 10 participating sites by compiling data from administrative communications.
Aim2b: Determine the effect of hospital triaging practices during the pandemic on CHD outcomes and resource utilization during and following the COVID-19 pandemic among participating hospitals. Specific outcomes include participating center case volume for both catheter-based and surgical procedures and the case-mix (types of congenital heart surgery and cardiac catheterization procedures performed) during the study period as compared to the calendar year preceding the pandemic (January 1, 2019 – December 31, 2019). Innovative models that are specifically utilized to investigate abrupt shifts in global practices will be employed to assess impacts of evolving triaging practices on outcome.

AIM 3 will provide ethical context to inform and guide triage and allocation with expert opinion from congenital cardiac ethicists, formulate policy to define elective versus non-elective procedures and hospital resource allocation.This information will be disseminated nationally with goal toward empirically-based standardization. Such policy would be essential for expediting response in any future crisis that drastically lowers resources to this high-risk patient population.