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.

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.

Hearing outcome of laser stapedotomy minus prosthesis (STAMP) versus conventional laser stapedotomy.

OBJECTIVE: The objective of this study was to compare short-and long-term hearing outcomes for patients undergoing primary laser stapedotomy minus prosthesis (STAMP) versus conventional laser stapedotomy. STUDY DESIGN: We conducted a retrospective case review of 167 consecutive patients from 1993 to 2002. SETTING: Otology/neurotology tertiary referral center. PATIENTS: We studied those with clinical otosclerosis without previous otologic surgery. INTERVENTIONS: Patients with otosclerosis confined to the fissula ante fenestram underwent STAMP. Patients with more extensive otosclerosis or anatomic contraindications to STAMP underwent standard laser stapedotomy. MAIN OUTCOME MEASURES: Pure-tone audiometry was performed before surgery, postoperatively, and on routine follow-up examination. RESULTS: Of the 183 ears in 167 patients, 128 (67.1%) underwent laser stapedotomy and 55 (32.98%) underwent STAMP. The STAMP mean air-bone gap (ABG) closed from a preoperative value of 22 dB (standard deviation [SD], 10 dB) to 6 dB (SD, 7 dB) on average follow up of 778 days. In 128 laser stapedotomy patients with an average follow up of 747 days, the preoperative mean ABG closed from 27 dB (SD, 10 dB) to 8 dB (SD, 7 dB). There was a trend toward improvement in high-frequency air conduction thresholds after STAMP versus worsening of high-frequency thresholds in the conventional stapedotomy group. There was a statistically significant improvement in most recent postoperative high-frequency (6000-8000 Hz) air conduction thresholds in the STAMP patients compared with patients who underwent conventional laser stapedotomy. CONCLUSION: Laser STAMP, when used for isolated anterior footplate otosclerosis, provides excellent high-frequency hearing, yields lasting results similar to conventional laser stapedotomy, and has a low incidence of refixation necessitating revision surgery.

Changing trends in the surgical treatment of Ménière's disease: results of a 10-year survey.

In order to discern trends in surgical procedures used to treat Ménière's disease in the United States during the 1990s, we mailed a questionnaire to 700 members of the American Otological Society and the American Neurotology Society. These physicians were asked about the frequency, results, and complications of surgical procedures for Ménière's disease that they had performed between Jan. 1, 1990, and Dec. 31, 1999. Questionnaires were returned by 137 surgeons (19.6%). Their responses indicated that the number of vestibular neurectomies, labyrinthectomies, and endolymphatic sac surgeries all decreased during 1999. Meanwhile, the use of office-administered intratympanic gentamicin therapy increased rapidly throughout the entire 10-year period, and by 1999 it had become the most frequently used invasive treatment for Ménière's disease. Surgeons now seem to reserve inpatient procedures for cases where intratympanic gentamicin fails to control vertigo.

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.

Laser stapedotomy minus prosthesis (laser STAMP): absence of refixation.

OBJECTIVE: To determine what percentage of patients with otosclerosis could successfully undergo a laser stapedotomy minus prosthesis over a 5-year period, and to determine the percentage of patients in whom refixation develops during follow-up. STUDY DESIGN: Retrospective case review of 136 patients (137 ears) who underwent primary surgery for otosclerosis. SETTING: An otology/neurotology tertiary referral center. PATIENTS: Patients were chosen if they had clinical evidence of otosclerosis without a history of otologic surgery. INTERVENTIONS: A standard stapes approach was used for all patients. For the laser stapedotomy minus prosthesis, a hand-held laser probe was used to vaporize the anterior crus of the stapes and perform a linear stapedotomy across the anterior one third of the footplate. If otosclerosis was confined to the fissula ante fenestram, the stapes became completely mobile. The stapedotomy opening was sealed with an adipose tissue graft from the ear lobe. MAIN OUTCOME MEASURES: Pure-tone audiometry with appropriate masking and auditory discrimination testing was performed before surgery, 6 weeks after surgery, and every year thereafter. RESULTS: Of the 137 cases, favorable anatomy and minimal otosclerosis allowed 46 (33.6%) of these patients to undergo laser stapedotomy minus prosthesis. Fifty-seven patients (41.6%) could not undergo the procedure because of extensive otosclerosis. The remaining 34 patients (24.8%) did not receive laser stapedotomy minus prosthesis because of other anatomic or technical difficulties. Of the 34 patients in the laser stapedotomy minus prosthesis group with more than 4 months follow-up, the average air-bone gap was closed from a mean of 22 dB (SD 10 dB) to 6 dB (SD 4 dB) 6 weeks postoperatively. Follow-up periods ranged from 5 months to 53 months (mean 767 days, SD 437 days). The long-term air-bone gap improved slightly to an average of 5 dB (SD 6 dB) in comparison with the sixth postoperative week value. CONCLUSION: Laser stapedotomy minus prosthesis is a minimally invasive procedure, which over the follow-up period has a very low incidence of refixation, as evidenced by a lack of progressive conductive hearing loss. The success of this procedure depends on the correct selection of cases. This procedure has been successfully performed on 33.6% of patients undergoing primary stapes surgery. Laser stapedotomy minus prosthesis seems to be a viable alternative to conventional stapedotomy that yields good results without evidence of refixation over an extended time.