Heart blockages affect about 500 babies per year in the U.S. (Photo: Courtesy of Children's Hospital Los Angeles)
Just like adults, a fetus can develop a conduction block that causes the heart to beat too slowly to pump enough blood for their growing bodies. While adults experiencing this can receive pacemakers, there is currently no way of treating heart blockages in early-stage fetuses.
This rare condition affects about 500 babies per year in the U.S., according to the American Pregnancy Association.
To give these unborn children a chance at life, Gerald Loeb, medical doctor and professor at the USC Viterbi Department of Biomedical Engineering and collaborating clinicians have invented the first micropacemaker to treat fetuses in utero.
“One of the things that attracts me to this problem is that it usually occurs in isolation,” Loeb said. “There are many syndromes that result in a very difficult existence once the child is born, but this isn’t one of them.”
Previous attempts to address congenial heart blocks in fetuses had focused on placing a pacemaker in the mother and attaching its electrical lead to the unborn child. However, they failed when the fetus changed position. Loeb's team figured out how to fabricate a pacemaker small enough to fit entirely in the fetus. The clinicians figured out how to implant it in the fetus through a 3.5 mm tube under ultrasound guidance.
“As it turned out, we were familiar with a medical power cell that was just the right size thanks to our previous work with neuromuscular stimulators,” said Loeb, adding that the project has received funding from the Coulter Foundation and National Institutes of Health, among other sources.
The pacemaker project, a joint collaboration between USC Viterbi engineers and clinicians from the USC Keck School of Medicine, “has resulted in a constant process of design and redesign as we have developed a device that meets all of the tremendous challenges of fetal pacing,” said Keck School Professor Yaniv Bar-Cohen, M.D.
The micropacemakers have already been successfully implanted in fetal sheep. The first human trials may occur within a year. After a positive human trial, the pacemakers would still need to go through a rigorous evaluation to receive FDA approval and insurance coverage. Only then would they become commercially available for clinical use.
“As I tell my students, no patient was ever made well by a journal article,” Loeb said. “In academia, we are often very happy when we get a publication or a grant, but if our goal is to make patients better, we have to commercialize our product so it’s actually available to them.”