“Aside from the gap posterially, you really can’t tell the difference between the two sides,” Dr. Lott said. On a video, the woman can be heard reading, with good voice quality.
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March 2022“We know that that proof of concept is there—that we can use that three-dimensional shape, we can get function, and we didn’t need to do a laryngectomy for her,” he said. That procedure has now been performed in a total of six patients, he added.
Then, Dr. Lott’s group moved on to a tissue-engineered implant so that tissue would grow over the scaffolding “to decrease the morbidity, decrease intraoperative time, and decrease the variability involved with flaps and tissue rearrangement.”
They turned to a canine model, using adipose-derived stem cells that were removed from the canine. They then cellularized the scaffold with a concentration of about 3 million cells. The cells were in a fibrin gel that would help move them into the porous material of the implant and then grow across its surface. Researchers then put the cellularized scaffold into the canine model and assessed the progress (Lott DG, et al. A tissue engineered construct for laryngeal regeneration: a proof-ofconcept device design study. Laryngoscope. Jan 27, 2022. Published online ahead of print).
“We’ve shown we can 3D print and mold these structures,” Dr. Lott said. “We decided to go with a molded structure because it’s easier to show the ability for it to maintain its parameters for the FDA.”
Hemilaryngectomy is oncologically sound and can circumvent many of the quality-oflife issues seen with total laryngectomy. The problem is, hemilaryngectomy has fallen out of favor to some degree with many surgeons due to the difficulty of achieving good laryngeal function after surgery. —David Lott, MD
Dr. Lott displayed pictures of the progression during his Triological meeting presentation that showed that by 12 months, the implant was completely covered with epithelium except for the medial portion of the vocal fold—a 3-mm area that had not epithelialized.
Nonetheless, the procedure was considered successful. The airflow and subglottal pressure were within normal limits, and acoustic signaling showed that there was strong harmonic content to the dog’s bark. On a sound clip, the dog’s bark sounds like a typical bark. There were also no swallowing or breathing problems. There was never any infection, and the canine thrived throughout the study, he said.
“I think part of the reason why it didn’t completely epithelialize is that the dog’s barking and coughing caused both strong tangential airflow across the surface and direct trauma to the surface from the normal vocal fold,” Dr. Lott explained. When they removed the implant, the muscle had pulled away from the concave component of it so that there wasn’t good vascularization, he said.