Implanted Stimulator Used to Treat Vocal Cord Paralysis

Newswise — Vanderbilt Voice Center patient Judit Kiss, 40, who lives about 25 minutes outside of Denver, enjoyed hiking in the mountains, running, and singing ‘You Are My Sunshine’ to her daughters, 9 and 11 years old.

As a nurse she felt a bump on her neck one day that didn’t seem right and was later diagnosed with thyroid cancer. She had a thyroidectomy to remove her thyroid gland and the cancer that went with it.

But side effects from the surgery caused her to experience vocal cord paralysis, a condition that affects not only her singing but also her breathing.

“My vocal cords didn’t fully open, they were just kind of lazy,” she said. “I couldn’t exercise, even walking up the stairs left me gasping for breath.

“I used to sing ‘You Are My Sunshine’ to my girls every night. But the last six years have been ‘You Are My Sun …’ (gasp for breath) ….”

Injury to both vocal cords (bilateral paralysis) is common in cancer patients who have had a resection, and makes patients feel like they are being strangulated.

Persons with this condition have vocal folds frozen in the near-closed position, which can make it difficult to breathe, according to David Zealear, PhD, professor of Otolaryngology – Head and Neck Surgery at Vanderbilt University Medical Center.

“The standard of care for these patients has been to enlarge the airway to improve breathing, but this sacrifices the patient’s ability to speak,” Zealear said.

Kiss had been searching online for an answer to her condition but was coming up empty until she read about a laryngeal pacer clinical trial, the first of its kind, led by Zealear at VUMC.

In fact, Vanderbilt is the only place in the world that has an implantable bilateral pacemaker that can stimulate opening of both vocal folds in patients with bilateral vocal fold paralysis, allowing them to both breathe and speak.

Further, the opening is much larger than that achieved by surgical enlargement, providing the patient the capacity to engage in strenuous exercise.

After decades of researching possibilities for reanimation of a paralyzed muscle, Kiss would be Zealear’s first patient in this NIH-funded clinical trial.

“She was the perfect candidate, and I could not have hoped for a better result — this is a really amazing proof of concept,” Zealear said.

There are 7,000 new patients each year diagnosed with vocal paralysis and a total of more than 80,0000 patients living with the condition across the world who would be candidates for the surgery, he said. His clinical trial is enrolling eight patients, with hopes to expanding to multisite studies moving forward.

Now six months into the trial, Kiss has a pacer implanted under her skin that cycles on for three seconds and off for three seconds, synced with her breathing rate, to allow her vocal cords to open.

“This allows me to do everything. I am not kidding when I say I have not been able to work out for six years,” she said. “I have always been an athlete, I have always been active, so it was really frustrating to not be able to do that.

“Now my pacer is implanted and it is on, and it is cranking. I recently was able to dance at my best friend’s wedding and there is no way I could have done that before. And I don’t feel it, it just does its thing,” she said.

Eben Rosenthal, MD, Odess Professor of Otolaryngology- Head and Neck Surgery and chair of the department, classifies the operation both as a success in itself and as necessary preparation for laryngeal transplants.

“Dave has been able to give new breath — pun intended — into new patients that had physically shut off their breathing,” Rosenthal said.

“Every day not being able to breathe as you go up a flight of stairs or walk any kind of distance is just incredibly traumatic, and it is a feeling of asphyxiation. It is like being smothered.”

Perhaps what is most exciting is the opportunity for using this idea in other settings, Rosenthal said.

“Many people get their voice boxes taken out for cancer, and we could conceivably transplant them if we had a way to open the vocal cords.

“The implications of this are not just for an unusual disease but for a common disease like throat cancer where you could conceivably give them a transplant with moving vocal cords.”