Building a Non-Invasive Cardiac Output Monitor for Infants and Children with Congenital Heart Disease

Johns Hopkins Medical Institute
Baltimore, MD

Principal Investigator: Danielle Gotlieb Sen, MS, MD, MPH, Pediatric and Congenital Cardiac Surgeon, Director of Pediatric Cardiac Research, and Director of Pediatric Surgery Quality & Outcomes Research.

Congenital heart disease (CHD) remains the single most common congenital anomaly, affecting nearly 1% of all annual births in the United States. Infants and children with CHD can have complex abnormalities in cardiac anatomy and physiology requiring surgical intervention and close hemodynamic monitoring. Cardiac output (CO), the amount of blood the heart can pump every minute, is a key variable - low CO is associated with significant morbidity and mortality. The current gold standard for calculating CO requires invasive cardiac catheterization. Though useful, catheterization produces an instantaneous value at a single discrete time point that almost certainly misses dynamic and clinically important variations. There are non-trivial procedural risks associated with cardiac catheterization, and catheterization is performed under general anesthesia, which itself alters the patient’s physiology. Non-invasive alternatives to catheterization have been tested in intensive care units but their accuracy and precision is highly variable; such devices are not fully validated against invasive measurements, and none are designed specifically for young children with CHD. We seek to develop a first-of-its-kind cardiac output monitoring device to give healthcare teams the power to non-invasively, accurately, and continuously measure and monitor CO in patients with CHD.

This project aims to do the following: 

1.     Build models predicting cardiac output by analyzing standard hemodynamic waveform data from a large retrospective cohort of patients with CHD undergoing cardiac catheterization.

2.     Using a novel, non-invasive device that integrates bioimpedance, bioreactance and near infrared spectroscopy technologies, collect waveform data from well babies and postoperative infants with CHD.

3.     Refine our algorithm for predicting cardiac output by prospectively collecting data from patients with CHD undergoing cardiac catheterization.