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.”
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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.
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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.
Claire Wasserman and Ashley Louise, mothers to 8-month-old twins Raphael and Antonia Wasserman, were waiting desperately for the stent to be approved.
Raphael was born with a congenital heart defect and had open heart surgery when he was just days old. But over the next several months, Raphael became sicker as the largest blood vessel in his body narrowed. His heart was struggling to pump blood, and he urgently needed another procedure.
“It became this kind of race with time,” Louise said. “How long can he wait putting off having this surgery if we are able to get to this point when the stent is approved.”
The approval came just in time for Raphael, who became one of the first babies to receive the device. Zahn was Raphael’s surgeon.
“I was definitely a little nervous as a physician who’s using something new on somebody’s baby,” he said. “No matter how long you do it you’re never not nervous when you’re doing something that’s relatively new realizing that you have somebody’s most precious possession on the table with you.”
Dr. Michael Argilla, a pediatric cardiologist and director of the pediatric catheterization laboratory at NYU Langone Health in New York City, said, “The word game-changer is thrown around a lot, but this stent really does change the frame of reference for a lot of our work, which is pretty amazing.”
The FDA approved the Minima stent to treat two heart conditions: coarctation, or narrowing of the aorta, which is the largest blood vessel in the body; and stenosis, or narrowing and hardening, of the pulmonary artery, which pumps blood from the heart to the lungs.
Shahanavaz said that with further testing, it’s possible that the stent will be approved to treat other congenital heart defects as well.
Since the surgery, Raphael is doing well in his recovery.
“It felt really amazing actually to witness medicine in progress and technology changing your life in a very real way,” Louise said. “He’s not going to have to have a stent replacement every three years for the next 20 years.”
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