While there have been a few randomized controlled trials demonstrating the effectiveness of BDET for patients with relatively mild Eustachian tube dysfunction, according to Dr. Saunders, there has been very little research on chronic ear disease.
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April 2023Dr. Poe noted that it’s difficult to judge how common BDET is in the United States because healthcare providers here don’t keep track of the numbers of these procedures being done.
Performing BDET requires special certification, either from taking a course from the company that sells their balloon device or through training in residency. “There are three FDA-approved devices in the United States, made by Acclarent, Stryker, and Medtronic,” Dr. Poe said. “If you’ve already used the Stryker device for sinuses, you don’t have to get certified for Eustachian tubes. At the academy course, about 70% say they have done the procedure. It’s become a widespread clinical treatment.”
While BDET isn’t yet FDA approved for use in children, Dr. Poe said it’s very popular in other countries and performed on children as young as 18 months. “The balloons we have in the United States aren’t designed for children,” he said. “There’s only one size.”
Dr. Poe has published research on BDET in children aged seven and said that children are very sensitive and there’s risk of overdilation where the valve won’t close, so it’s important to be especially careful in selecting patients. He’s comfortable performing it in children aged five and above, scaling down the amount of time that the balloon is used, but says smaller balloons and more research are needed.
Balloon Dilation-Assisted Cricoid Split Procedure
Balloon dilation has also been used in rib graft placement via an endoscopic posterior cricoid split, a novel modification described by Ahmed AlAmmar, MD, at King Saud University in Riyadh, Saudi Arabia, senior author of a study published last January in The Laryngoscope with co-author and colleague Bshair Aldriweesh, MD, associate consultant, pediatric otolaryngology and airway surgery, King Fahad Specialist Hospital Dammam, Dammam, Saudi Arabia (Laryngoscope. 2022;132:212–214).
According to the study, endoscopic posterior cricoid split and rib grafting (EPCS/RG) was performed in patients with subglottic stenosis, posterior glottic stenosis, and bilateral vocal fold paralysis. Placement of the cartilage graft into the divided cricoid lamina is considered a challenging step in this procedure and the study presents a modified EPCS/RG that used balloon dilation between October 2017 and April 2021 with five patients, ages 11 to 19, to aid in this step. The main outcome measures were resolution of dyspnea, prevention of aspiration, and the need for more surgeries.