First miniature, adjustable stent implanted in 5-month-old with congenital heart defects
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On Feb. 1, the first-in-human implantation of a novel miniaturized stent for infants and small children that can be expanded as they grew was performed at Children’s Hospital Los Angeles.
The procedure was the first in a multicenter early feasibility study to test the efficacy and safety of this miniaturized, adjustable stent for very young patients (Minima, Renata Medical). This was the first in-human implantation of the new device, as it was previously only tested in piglets.
“Vascular stents that can ultimately reach adult size and be safely implanted in neonates, infants and young children have long been an unmet need in our field,” Darren P. Berman, MD, director of congenital interventional catheterization with the Heart Institute at Children’s Hospital Los Angeles, told Healio. “An ‘adult-sized’ stent is a stent that can be further expanded to keep up with the normal growth of a blood vessel as a child grows. Until now, implanting an adult-sized stent typically required a large-sized catheter. Because of this, neonates, infants and young children have not had this technology readily available to them, as their blood vessels are not large enough to be able to safely implant the desired stent.”
The first recipient of the new stent, a 5-month-old boy named Asher, was born with two congenital heart defects, dextro-transposition of the great arteries and coarctation of the aorta.
The patient underwent prior surgeries at Children’s Hospital Los Angeles to repair the defects and reopen the aorta, which were ultimately unsuccessful.
The patient experienced a long recovery from the first surgery, according to the release, and was therefore selected to receive the new stent.
“Right off the bat, we were excited,” Hilla, the patient’s mother, said in the release. “But when we learned that Asher would be the first human [to receive it], that set us back a bit. We were scared. But after weighing the pros and cons, we decided to try the stent. It was minimally invasive and less pain and a shorter recovery for Asher. That’s what we were looking for.”
The procedure was performed by Berman and Patrick Sullivan, MD, attending physician at the Heart Institute at Children’s Hospital Los Angeles and clinical assistant professor of pediatrics at the Keck School of Medicine of USC.
“Asher has complex congenital heart disease that will require a lifetime of follow-up. The use of this stent allowed us to prevent another open-heart surgery for him,” Berman told Healio. “We expect him to be able to live a normal, healthy life with routine follow-up with the Heart Institute team at Children’s Hospital Los Angeles.”
As described by Berman in the press release, the stent delivery system is approximately “the size of a piece of spaghetti.”
As the patient grows, the stent will be expanded via repeated minimally invasive catheter procedures to a maximum width of 18 mm. According to the release, the stent will likely need to be expanded two to four times over the lifetime of the patient.
The patient was discharged to home the day after the procedure and is doing well, according to the release.
“We are actively enrolling patients in an early feasibility study. We plan to enroll 10 patients across four centers in the U.S.,” Berman told Healio. “The FDA will then review this preliminary data, and then we anticipate proceeding with a larger prospective study enrolling a total of 40 patients across more centers in the U.S. Based on the results of this larger study, we will seek FDA approval.”
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