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Fetal Risk-Assessment Protocol Developed at Children's National Predicts Complications from Congenital Heart Disease at Birth

 Mary Donofrio

Mary T. Donofrio, MD, Director of the Fetal Heart Program and Critical Care Delivery Program at Children’s National Health System, has published the conclusions of an eight-year study determining the accuracy of a delivery room risk-assessment ranking protocol for babies diagnosed in utero with congenital heart disease (CHD), in the Journal of the American Society of Echocardiography.

The study concluded that fetal echography (a detailed ultrasound of the heart), enables accurate delivery room and neonatal Level of Care (LOC) stratification, and should be used in planning for postnatal care of fetuses diagnosed with CHD to predict the likelihood and range of complications that may occur at birth.

According to the protocol, when a baby is diagnosed in utero with CHD using fetal echocardiography, the images are evaluated using a “risk-stratified” system to determine the potential for serious illness or even death after delivery. A delivery room LOC ranking from 1-4 is assigned for the fetal patient, depending on the condition, severity, and expected postnatal course.  A care plan is then created to be used at the time of birth to minimize compromise and improve outcomes for the baby.

The study determined that the protocol is highly effective at predicting the necessary level of postnatal care for fetuses diagnosed with CHD; LOC was correctly determined in 92 percent of the patients (427 in total) who underwent evaluation and care after birth. Twenty-seven patients were assigned a higher LOC than ultimately required at birth. Only nine patients were assigned an LOC that was lower than needed at delivery; of note is that seven were patients with D-TGA (CHD in which the position of the aorta and pulmonary arteries are inverted). The study concluded that all patients with D-TGA diagnoses should be assigned LOC 3 or 4 to optimize clinical outcomes.

The protocol, initially developed by Dr. Donofrio in 2004, was expanded and published in an American Heart Association Scientific Statement in 2014, the first reported Guidelines for the Diagnosis and Treatment of Fetal Cardiac Disease. It is now used in many healthcare centers across the U.S. The protocol has also recently been adapted for fetuses diagnosed with non-cardiac abnormalities at Children’s National.

“Our protocol has resulted in better coordination between community physicians and Children’s National specialists, allowing for the best possible neonatal care for patients diagnosed in utero with CHD,” said Dr. Donofrio. “We now can predict how sick a baby will be at birth. The Level of Care (LOC) protocol is our systematic approach to care that allows us to use evidenced based medicine and clinical expertise to create an individualized care plan for each baby we evaluate.”

In most cases, only routine delivery room care (LOC 1) is needed and cardiology consultation with outpatient or telemedicine follow-up with a Children’s National specialist is arranged.

In some instances, specialty care is required before transfer to Children’s National for surgery or other intervention (LOC 2). In these cases, care is coordinated between the neonatologist at the local hospital and the specialists at Children’s National.

In rare cases when it is anticipated that severe illness or death may occur (LOC 3 or 4), babies are delivered in Children’s National cardiac operating rooms and receive highly specialized care from an integrated team including cardiologists, interventionalists, intensivists, anesthesiologists,  and nursing staff.

“Fetal medicine has really advanced in recent years. The fetus is now considered to be a patient from the time of in utero diagnosis, and care starts immediately. We can now create an individualized management plan for each baby using the best care strategies available. We are truly integrating the science and art of medicine to improve outcomes starting right at birth,” adds Dr. Donofrio.

Contact: Emily Hartman at 202-476-4500

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