The Food and Drug Administration recently approved a heart stent made specifically for infants and young children, a device that could help kids born with certain congenital heart defects avoid a series of open heart operations over their childhoods.
About 40,000 babies are born with congenital heart defects in the U.S. each year, according to the Centers for Disease Control and Prevention. In some cases, those defects are treated with stents, which prop open blood vessels, ensuring that blood can properly flow through them.
Typically, when infants and young children need stents, surgeons trim or modify adult-size stents and squeeze them into the tiny vessels of infants’ hearts, which are about the size of a walnut. (An adult’s heart is about the size of a fist.)
“What we’ve been doing for the past three decades is kind of jerry-rigging these adult stents and making them work for our patients,” said Dr. Evan Zahn, a pediatric cardiologist and director of the Guerin Congenital Heart program at Cedars Sinai Medical Center in Los Angeles. “You can imagine that is less than ideal — they’re too big.”
This means that as the child grows older and their blood vessels get bigger, stents have to be replaced, often with open heart surgery, Zahn said.
“It’s not unusual to have kids who are going into middle school who’ve had four or five or even six open heart surgeries,” he said. “Their survival is great, but the amount of what I call therapeutic trauma that they have to go through is quite a burden.”
The Minima stent, from the California-based biotech company Renata, is designed to grow with the child as he or she ages. Zahn is the company’s chief medical officer.
Instead of surgery, the size of the stent can be adjusted with a minimally invasive procedure through a blood vessel in the groin. Patients are usually able to go home about a day later, compared with around seven days for open heart surgery, including some days in the ICU.
Dr. Shabana Shahanavaz, pediatric cardiologist and director of the cardiac catheterization lab at Cincinnati Children’s Hospital, said that in her 15 years of practice she’s never seen a stent that was specifically manufactured for babies.
“That is mind-boggling to think that it wasn’t there before,” said Shahanavaz, who consults for Renata.