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Recent studies by investigators using each of these systems demonstrated the superiority of this technology over medical therapy alone for patients with ETD (Laryngoscope 2018;128:1200–1206; Otol Neurotol. 2018;39:894–902). In May 2018, Poe and colleagues reported results of a multicenter, prospective, randomized, controlled trial that showed that patients treated with balloon dilation plus medical management had significantly greater tympanogram normalization at six weeks compared to those who received medical management alone (51.8% vs. 13.9%) (Laryngoscope. 2018;128:1200–1206). At 24 weeks, 62.2% of patients treated with balloon dilation plus medical management had tympanogram normalization. In addition, patients treated with balloon dilation and medical management reported significant improvement in symptoms based on Eustachian Tube Dysfunction Questionnaire-7 Symptom (ETDQ-7) scores at six-week follow-up compared to those treated with medical management alone (56.2% vs. 8.5%).
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September 2018In June, Meyer and colleagues reported similar results, albeit based on the primary endpoint of ETDQ-7. In this study, patients treated with balloon dilation and medical management had a significantly mean change in overall ETDQ-7 score at six weeks of -2.9, compared with -0.6 for those treated with medical management alone. These improvements were maintained through 12 months for the patients treated with balloon dilation. The study also found that 66.7% of patients treated with balloon dilation and medical management had a significant improvement in tympanogram normalization at six weeks from baseline compared with 0% of patients treated with medical management alone.
Importantly, this last study also shows that this procedure can be done in the office setting. Unlike the study conducted by Poe and colleagues, in which all the procedures were conducted in the operating room, 72% of the procedures in the Meyer study were conducted in an office setting under local anesthesia.
According to lead author of the study, Ted A. Meyer, MD, PhD, director of the Cochlear Implant Center and associate professor in the department of otolaryngology–head and neck surgery at the Medical University of South Carolina in Charleston, patients generally tolerated the procedure as well in the office setting as in the operating room. As with any in office procedure, he said, pain management is a primary challenge.
An ongoing challenge with using this technology is reimbursement, he said. To date, there are no appropriate CPT codes for the procedure, so billing and insurance issues remain challenging. “There are lots of financial issues that still are needing to be worked out,” he said.