Thousands of newborn babies die or suffer serious illness each year for want of a cheap, readily available medical device to test for congenital heart disease, according to neonatal health experts.
Nearly 1.3 million babies each year are born with congenital heart disease, making it among the top 1 or 2 most common birth defects in nearly every developed or developing country. CHD accounts for nearly 1 in 3 infant deaths attributed to birth defects and about 3% of all infant deaths that occur in the 1st year of life, according to the Centers for Disease Control & Prevention.
In the U.S. alone, about 40,000 babies each year are diagnosed with CHD; of those, about 4,000 don’t live to see their 1st birthday. But nearly half could have been saved if their condition had been detected earlier – or at all, according to Newborn Foundation co-founder and chairman Annamarie Saarinen.
Physician’s don’t have the tools to prevent CHD from occurring, but with proper screening and the right technology they may be able to catch the condition within a baby’s 1st 24 hours, allowing them to take swift action and potentially prevent those "2 a.m. calls" that spell disaster for a newborn.
"When you get a call at 2 in the morning, it’s because a child has crashed, either at home or in the emergency department, and they then end up spiraling downward with multiple organ dysfunction," said Dr. Peter Cox, clinical director of critical care medicine for the Hospital for Sick Children in Toronto. "If one can detect this early enough, before you actually reach that stage, you present to surgery with a child who is far more physiologically stable."
Detecting CHD before symptoms appear can be the difference between treating an infant who appears otherwise healthy and attempting to perform surgery on one who may already be in a dire state.
The screening technology is available and pretty cheap, Saarinen said; the challenge is implementation. A specialized pulse oximeter, 1 that accounts for motion and low perfusion, could help doctors catch CHD earlier and more often. Medtech company Masimo (NSDQ:MASI), which sponsors the PSSTS meeting, makes just such a device.
Still, some hospitals rely on "lowest common denominator" devices intended for adults, which may miss the condition or produce false positives, according to Dr. Mitch Goldstein, associate professor of pediatrics at Loma Linda University Children’s Hospital.
Other hospitals have no process in place to screen infants at all, despite the fact that pulse oximeters that fit the bill for neonatal screening are already FDA-approved and available on the U.S. market.
Pulse oximetry is a non-invasive, painless test used to determine pulse rate and the amount of oxygen in the blood. The test takes about 3-5 minutes to produce results that can indicate the presence of a potentially deadly heart defect. A newly developed mobile pulse oximeter may bring similar life-saving potential to developing areas, Saarinen said.
When Saarinen attended the PSSTS conference at this time last year, she reported that less than 15% of babies born in the U.S. were screened for CHD and only 9 states had fully implemented proper screening as part of routine neonatal care. Even then, the program was saving lives.
"We have 220 lives saved," Saarinen said. "These are babies that would have been discharged with critical heart lesions."
By Q3 of this year about 80% of U.S. babies will undergo screening, with 33 states signed up to fully launch neonatal pulse oximetry programs, thanks largely to the efforts of the Newborn Coalition and other groups, Saarinen said.
CHD concerns have played a big role in the PSSTS conference both years since the Patient Safety Movement’s conception, representing 1 of the challenges the group hopes to tackle. Backed by pulse oximetry devices maker Masimo, the foundation aims to entirely eliminate preventable hospital deaths by the year 2020, including those associated with hospital-acquired infections, medication errors and surgical mistakes such as objects left inside a patient’s body.