Custom 3D-Printed Tracheal Splints

For most affected children, tracheomalacia—a congenital deformity of the trachea that causes the airway to collapse with breathing and coughing—is a medically manageable inconvenience that resolves over time. But for some children and families, tracheomalacia is a life-threatening condition that also interferes with child development and family bonding.

Justice Altidor was one of those children. Justice and her twin, Journee, were born at 34 weeks gestation because doctors were concerned about twin-to-twin transfusion syndrome, said Emanuella Altidor, the girls’ mother. Justice had also been diagnosed with a double aortic arch while in utero.

“They whisked her away as soon as she came out because they noticed her difficulty breathing,” Ms. Altidor said.

Justice was intubated, connected to a ventilator, and scheduled for cardiac surgery. She underwent surgical repair of the double aortic arch eleven days after birth but continued to have breathing difficulties. Justice had severe tracheomalacia; she was ventilator-dependent and required intensive care. Her parents couldn’t pick her up because the slightest movement could shift her breathing tube out of place and trigger a respiratory crisis.

Not so very long ago, Justice would have likely spent the first years of her life tethered to a ventilator and in and out of the hospital—if she survived. The estimated mortality rate for severe tracheomalacia is 80% (Int J Pediatr Otorhinolaryngol. 2023;169:111559).

“These kids can be so sick that, if the breathing tube moves just a tiny bit, they can experience complete respiratory arrest,” said Kevin Maher, MD, a pediatric cardiologist who is director of the Cardiac Intensive Care Unit at Children’s Healthcare of Atlanta.

But thanks to medical innovation, collaboration, and a few custom 3D-printed, bioabsorbable tracheal splints, Justice was able to go home with her parents and sister—without a ventilator or oxygen—just four months after birth. She was free to crawl, sit, and eventually run. Now four years old, Justice plays soccer, rides her bike, and swims.

The treatment that enhanced Justice’s life isn’t yet widely available. Only five institutions in the U.S. currently offer tracheal splints to support the airway, and the Georgia Institute of Technology is one of only two locations capable of custom printing these devices. Each case must be individually considered and submitted to the U.S. Food and Drug Administration (FDA) for possible approval under expanded access guidelines for lifesaving, cutting-edge therapies. To date, approximately 30 children have undergone surgical implantation of the custom airway splints.

These devices have had a profound impact on the children who receive them, their families, and the medical professionals involved. And, someday, the innovation that led to this transformative treatment may advance otolaryngology.

Managing Severe Tracheomalacia

Tracheomalacia is the most common congenital tracheal defect, with one in 2,100 children born with the condition, according to the National Organization for Rare Disorders. Most children with the condition have a mild to moderate presentation, and symptoms may improve and even resolve by two years of age. Children with severe cases of tracheomalacia may also experience significant improvement as they grow.

“The vast majority of these kids will actually outgrow it,” said Matthew Brigger, MD, MPH, a pediatric otolaryngologist who serves as director of the Center for Pediatric Aerodigestive Disorders and Airway Surgery at Rady Children’s Hospital-San Diego. “You just have to give it time. Sometimes, you need a tracheostomy to get to that point.”

Fortunately, few children have severe tracheomalacia. “It’s rare in the sense that you’re not going to see one case a week. But if you’re in a high-volume center, you’ll see two or three a year,” said Steve Goudy, MD, division chief of otolaryngology at Children’s Healthcare of Atlanta. “Tracheostomy and ventilation are the historical answers” that allow children to go home with their families, he said.