Balloon Dilation of the Eustachian Tube: 12-Month Follow-up of the Randomized Controlled Trial Treatment Group.

OBJECTIVE: Obstructive eustachian tube dysfunction (OETD) affects up to 5% of adults; however, available treatment strategies have limitations. It was previously reported that balloon dilation of the eustachian tube (BDET) with the eustachian tube balloon catheter + medical management (MM) results in a significantly higher proportion of subjects with normalized tympanograms versus MM alone at 6- and 24-week follow-up. The current analysis extends these initial findings by investigating the durability of BDET + MM treatment outcomes through 52 weeks. STUDY DESIGN: Prospective cohort follow-up study from the treatment group in a previously reported multicenter randomized controlled trial. SETTING: Twenty-one investigational sites across the United States. SUBJECTS AND METHODS: Here we report on secondary and exploratory endpoints for patients with OETD who previously failed MM and were randomized to the BDET + MM cohort. Analyses of tympanogram outcomes are reported by ear, unless specified otherwise, as a more accurate measure of durability of the procedure over time. RESULTS: Among subjects randomized to BDET + MM, the overall number with normalized tympanograms and ETDQ-7 scores (Eustachian Tube Dysfunction Questionnaire-7) remained comparable to those reported at 6- versus 52-week follow-up: tympanograms, 73 of 143 (51.0%) versus 71 of 128 (55.5%); ETDQ-7, 79 of 142 (55.6%) versus 71 of 124 (57.3%). The overall number of ears with normalized tympanograms also remained comparable, with 117 of 204 (57%) versus 119 of 187 (63.6%). CONCLUSIONS: The present study suggests that the beneficial effects of BDET + MM on tympanogram normalization and symptoms of subjects with refractory OETD demonstrate significant durability that is clinically relevant through 52 weeks.

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.

Silverstein MicroWick.

Using the MicroWick to deliver otic medication to the inner ear fluids isa new, unique, effective, safe, efficient, and inexpensive method to treat inner ear disease. This self-treatment method using otic medication represents a major breakthrough in the treatment of inner ear disease. It allows the otologist to treat inner ear disease much as the ophthalmologist treats eye disease using eye drops. In the future, new drugs and medications will likely be developed that will relieve vertigo attacks, improve certain types of sensorineural hearing loss, and reduce tinnitus. The MicroWick will be available for patients to self-administer these medications to the inner ear through the round window membrane.

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.

Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial with 1-year follow-up.

BACKGROUND: The objective of this prospective, multicenter, randomized trial was to evaluate and compare 1-year outcomes from the REMODEL study between office balloon dilation and functional endoscopic sinus surgery (FESS). METHODS: Adults with maxillary chronic rhinosinusitis (CRS), including those with anterior ethmoid disease, who failed medical management and were surgical candidates for FESS, underwent either standalone balloon dilation or FESS in a 1:1 randomization scheme and were followed through a minimum of 1 year. Sinonasal symptom improvement was assessed using the validated 20-item Sino-Nasal Outcome Test (SNOT-20) survey. Standardized effect sizes were computed to further assess clinical significance. Ostial patency rate, rhinosinusitis episode frequency, impact of sinus disease on activity and work productivity using the validated Work Productivity and Activity Impairment survey, complications, and revision rate were also compared between the two groups. RESULTS: Ninety-two patients (50 balloon dilation; 42 FESS) were treated and 89 (96.7%) completed 1-year follow-up. Both groups showed clinically meaningful and statistically significant (p < 0.0001) improvement in mean overall SNOT-20 scores and in all four SNOT-20 subscales. The 1-year mean change in SNOT-20 after balloon dilation (-1.64) was noninferior to FESS (-1.65; p < 0.001). The standardized effect size was large, showing clinically significant improvement for both interventions. Ostial patency was 96.7 and 98.7% after balloon dilation and FESS, respectively, and each group reported significant reductions (p < 0.0001) in rhinosinusitis episodes (mean decrease, 4.2 for balloon dilation and 3.5 for FESS). Overall work productivity and daily activity impairment due to chronic sinusitis were significantly improved (p < 0.001) in both groups. There were no complications and revision surgery rate was 2% in each arm through 1 year. CONCLUSION: With 1-year follow-up, standalone balloon dilation is as effective as FESS in the treatment of CRS in patients with maxillary sinus disease with or without anterior ethmoid disease who failed medical therapy and met the criteria for medically necessary FESS.

Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial.

BACKGROUND: A prospective randomized controlled study was conducted on patients with chronic rhinosinusitis (CRS) to test the hypotheses that symptom improvement after balloon dilation was noninferior to functional endoscopic sinus surgery (FESS) and balloon dilation was superior to FESS for postoperative debridements. METHODS: Adults with uncomplicated CRS of the maxillary sinuses with or without anterior ethmoid disease who met criteria for medically necessary FESS were randomized 1:1 to office balloon dilation or FESS and followed for 6 months. A minimum of 36 patients per arm were required to test the hypotheses with 90% power. Symptom improvement using the validated 20-item Sino-Nasal Outcome Test (SNOT-20) survey, debridements, recovery outcomes, complications, and revision surgeries were compared between groups. RESULTS: Ninety-two patients (50 balloon dilation; 42 FESS) were treated. Mean SNOT-20 improvement was 1.67 ± 1.10 and 1.60 ± 0.96 in the balloon and FESS arms, respectively. Both groups showed clinically meaningful and statistically significant (p < 0.0001) improvement and the balloon arm was noninferior (p < 0.001) to FESS. The mean number of postprocedure debridements per patient was 0.1 ± 0.6 in the balloon arm versus 1.2 ± 1.0 in the FESS arm, with the balloon group showing superiority (p < 0.0001). Occurrence of postoperative nasal bleeding (p = 0.011), duration of prescription pain medication use (p < 0.001), recovery time (p = 0.002), and short-term symptom improvement (p = 0.014) were all significantly better for balloon dilation versus FESS. No complications occurred in either group and one revision surgery was reported in each arm. CONCLUSION: Balloon dilation is noninferior to FESS for symptom improvement and superior to FESS for postoperative debridements in patients with maxillary and anterior ethmoid disease. Balloon dilation is an effective treatment in patients with uncomplicated CRS who meet the criteria for medically necessary FESS.