Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial.

OBJECTIVES/HYPOTHESIS: To assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dilatory dysfunction. STUDY DESIGN: In this prospective, multicenter, randomized, controlled trial, we assigned, in a 2:1 ratio, patients age 22 years and older with Eustachian tube dilatory dysfunction refractory to medical therapy to undergo balloon dilation of the Eustachian tube with balloon catheter in conjunction with medical management or medical management alone. METHODS: The primary endpoint was normalization of tympanogram at 6 weeks. Additional endpoints were normalization of Eustachian Tube Dysfunction Questionaire-7 symptom scores, positive Valsalva maneuver, mucosal inflammation, and safety. RESULTS: Primary efficacy results demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone. Tympanogram normalization at 6-week follow-up was observed in 51.8% (72/139) of investigational patients versus 13.9% (10/72) of controls (P < .0001). Tympanogram normalization in the treatment group was 62.2% after 24 weeks. Normalization of Eustachian Tube Dysfunction Questionaire-7 Symptom scores at 6-week follow-up was observed in 56.2% (77/137) of investigational patients versus 8.5% (6/71) controls (P < .001). The investigational group also demonstrated substantial improvement in both mucosal inflammation and Valsalva maneuver at 6-week follow-up compared to controls. No device- or procedure-related serious adverse events were reported for those who underwent balloon dilation of the Eustachian tube. CONCLUSIONS: This study demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone to treat Eustachian tube dilatory dysfunction in adults. LEVEL OF EVIDENCE: 1b. Laryngoscope, 128:1200-1206, 2018.

Transtympanic perfusion: indications and limitations.

PURPOSE OF REVIEW: To review the most recent literature regarding the application of transtympanic inner ear perfusion in the treatment of inner ear disorders including Meniere disease, sudden sensorineural hearing loss, and autoimmune inner ear disease. RECENT FINDINGS: The use of gentamicin perfusion in the management of Meniere disease with intractable vertigo has been demonstrated to have a very high rate of success, and is much less invasive than alternative surgical procedures such as vestibular nerve section or labyrinthectomy. The technique for achieving the highest rate of success while still minimizing the risk of cochleotoxicity continues to be investigated. Sustained delivery techniques such as the Silverstein MicroWick appear to achieve the best pharmacokinetic profile within the inner ear fluids. The end point of treatment does not necessarily require complete vestibular ablation to cure the patient, and shorter courses of treatment may help to reduce the risk of hearing loss. Cochlear Meniere disease can be treated with dexamethasone 4 mg/cc perfusion of the inner ear, which may improve the hearing, tinnitus, and pressure in the ear. Sudden sensorineural hearing loss has been managed with transtympanic steroid delivery, and this appears to be beneficial for some patients who have failed to respond to oral steroids, or have medical contraindications to systemic steroids. SUMMARY: Inner ear perfusion via transtympanic delivery is an emerging technique in the management of inner ear disease. Improved results are expected over time as research in this area answers questions about dosage and delivery techniques, as well as identifying new applications and pharmaceuticals.

Gentamicin perfusion vestibular response and hearing loss.

OBJECTIVE: To compare hearing results as a function of vestibular ablation in the treatment of Ménière's Disease, using gentamicin perfusion. STUDY DESIGN: A retrospective review of patients with Ménière's Disease treated by gentamicin perfusion of the inner ear via the MicroWick device. SETTING: A tertiary otologic referral center. PATIENTS AND INTERVENTIONS: The charts of patients treated with gentamicin perfusion via the MicroWick between the years 1998 and 2000 were reviewed. The results for patients with functional hearing in the affected ear were analyzed and were compared with the results in patients without functional hearing. MAIN OUTCOME MEASURES: Audiologic and vestibular test results as well as subjective symptoms. RESULTS: There were 45 patients who met the inclusion criteria. The averages for speech discrimination score and pure tone average before treatment were 92% and 38 dB, and after treatment were 82% and 47 dB. Patients were divided into two groups: Group 1 (20 patients), less than 75% ice air caloric reduced vestibular response (RVR); Group 2 (25 patients), those who reached greater than 75% ice air caloric RVR. There were 8 patients (17.6%) with persistent vertigo; 7 were from Group 1, and 1 was from Group 2, which was statistically significant (p = 0.007)wwww. The pure tone average dropped an average of 3 dB for Group 1 and 15 dB for Group 2. The difference in hearing loss between the two groups was statistically significant (p = 0.01). CONCLUSION: This study suggests that there is a correlation between the degree of vestibular ablation, the control of vertigo, and the risk of hearing loss. Patients with functional hearing seem to have a similar success rate for vertigo control, compared with patients who already had lost functional hearing before treatment. Future investigation may determine if less than 100% RVR, but greater than 75% RVR, is an alternative end point with adequate vertigo control and reduced risk of hearing loss.

Direct application of dexamethasone for the treatment of chronic eustachian tube dysfunction.

We undertook a prospective study to determine the safety and effectiveness of the direct administration of a steroid to the eustachian tube via the Silverstein MicroWick in 11 patients with chronic eustachian tube dysfunction, including two who had Samter's triad. All patients had previously been treated with medical therapy and surgical middle ear ventilation without resolution. The MicroWick was placed directly in the eustachian tube orifice through a pressure-equalization tube. Patients received 3 drops of dexamethasone 4 mg/ml three times a day. The drops were discontinued after 4 weeks, and the MicroWick and ventilation tube were removed after 3 months. At study's end, eight patients (72.7%) reported subjective improvement in terms of a reduction in aural pressure and fullness. Audiometric testing demonstrated a 55% reduction in the mean air-bone gap and a 3% increase in the mean speech discrimination score. Bone pure-tone averages remained stable. Tympanometry showed that five patients (45.5%) converted from type B or C tympanograms to type A. Four patients (36.4%) had persistent perforations. Both patients with Samter's triad improved with therapy. These preliminary results suggest that direct dexamethasone administration to the eustachian tube is safe and effective for the treatment of chronic eustachian tube dysfunction. Long-term studies to confirm these findings are under way.