Heart Disease Screening in Newborns

Heart disease screening in newborns

People may not realize that heart disease is a significant health problem in newborns.??Congenital heart diseases (CHD) are a leading cause of birth defect-associated infant illness and death.?According to the CDC, about 1 in 100 babies are born with, of which 25% are considered critical congenital heart disease (CCHD).?Arrhythmias occur?in 1% to 5% of all newborns (Dubin, Neoreviews 2000 1 (8): e146–e151).?One in every 2000 babies are born with long QT syndrome, a genetic condition that can cause arrhythmia and sudden death (Schwartz et al, Circulation 2009; 120:1761–1767).?Studies have found that 10-15% deaths from sudden infant death syndrome (SIDS) are likely due to arrhythmias??from undiagnosed long QT syndrome.

Currently all babies born in the US are screened by pulse oximetry for CCHD on?the second day of life.??Despite the success of this public health mandate, about half of babies with CCHD are missed, which leads to delays in diagnosis and management.

Electrocardiogram (ECG or EKG) is an important tool in the diagnosis of heart disease in pediatric patients.?ECG can detect newborns with arrhythmias to allow early treatment.?Of those babies with CCHD who are missed by pulse oximetry screening, a 12-lead ECG may show abnormalities to enable early detection.?Studies have also found that prospective screening of newborns by 12-lead ECG can identify babies with long QT syndrome early, so that effective therapy can be instituted to prevent sudden death (SIDS).?In a study published in 2019, our research team reported that using an ECG designed for pediatrics and laypeople use, parents could do a standard 12-lead ECG test on their own babies (Lin et al. Home use of a compact, 12?lead ECG recording system for newborns. DOI: 10.1016/j.jelectrocard.2019.01.086).

The ECG technologies we have developed at QT Medical are making differences in many sectors of health care all over the world.?PCA 500 is the only medical standard 12-lead ECG cleared by the FDA and CE Mark for professional and patient use.?It is now used in hospitals, clinics, telehealth practice, clinical trials, commercial flights, schools and by thousands of patients at home.?In 2023, we are planning to offer newborn ECG screening services for early detection of long QT syndrome, arrhythmias and CCHD.?After many years of research, development and validation, we are now very close to what we planned to do in the very beginning of this journey—to make an impact on the care of heart diseases in thousands of babies.