CLEVELAND – In 2003, Keith Medovich, in his forties, fought off a lung cancer diagnosis through rounds chemotherapy and radiation.
And while the treatments were ultimately successful, in 2015, he began having trouble breathing.
As it turned out, despite being cured of his cancer, Medovich was one of a rare group of people who suffer long-term side effects from high-dose chemotherapy and radiation treatments
Portions of his trachea and bronchus were becoming severely constricted due to scarring and other after-effects from his prior radiation treatment. This condition – called tracheal stenosis – can narrow the windpipe so significantly a person can barely function.
“After a while, I couldn’t do anything from the shortness of breath,” said Medovich. “I couldn’t work. I couldn’t walk 100 feet to the mailbox. I couldn’t even lay down to sleep. I had to sleep sitting up in a chair. I told the doctor, ‘I just want to be able to mow my grass again’.”
According to Sonali Sethi, M.D., Medovich’s interventional pulmonologist at Cleveland Clinic, most patients who need a narrowed airway to be opened wider can benefit from standard, ‘off-the-shelf’ stents, which typically come in just a few shapes and sizes. However, she said this approach would not work for Medovich.
“His airway was completely distorted, twisted and narrowed,” said Dr. Sethi. “It no longer looked like a person’s normal airway, and the opening was as small as a pin prick. A standard stent would only work for a short time.”
Breathing difficulty forced Medovich and his wife Brigitte to make two emergency 50-mile trips to Cleveland Clinic from their hometown of Warren, Ohio. Upon arriving the second time, he was admitted to the intensive care unit with acute respiratory failure.
Medovich’s doctors knew his treatment options were exhausted. So, they appealed to the U.S. Food and Drug Administration (FDA) to allow him to be treated with first-of-its-kind, patient-specific, Y-shaped stent made from a 3D-printed mold, created and developed by Cleveland Clinic interventional pulmonologist Thomas Gildea, M.D.
The patient-specific stent was not yet FDA approved, so the team asked if one could be developed for Medovich under the agency’s “compassionate use” provision.
The request was granted, and shortly after, using a CT scan of Medovich’s chest and throat, and 3D visualization software, the stent – made of medical-grade silicone – was created to perfectly fit into his airways.
“For Keith, we went through every type of treatment procedure we could think of and nothing worked,” said Dr. Gildea. “He became the third patient we’d ever treated with the patient-specific stent, but the first with a problem in the trachea.”
Immediately upon awaking, Medovich said he felt like a new man.
“I could breathe again. The difference was like night and day,” he said.
Today, Medovich can once again mow his lawn and has even gone back to long-haul truck driving. He only requires maintenance or scheduled replacements of the stent every six to 12 months.
Since his procedure, the FDA has approved the patient-specific stent.
Dr. Gildea, who has been working on the concept since 2014, is eager to see the positive effects the devices can have on the 30,000 or so patients requiring airway stents each year in the United States.
“Shortness of breath is quite insidious, and over time it can get progressively worse,” he said. “As Keith showed, a patient can go from feeling totally incapacitated to feeling completely normal with the right stent.”