Efficacy and Safety of Intranasal Betahistine in the Treatment of Surgery-Induced Acute Vestibular Syndrome: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Study.

OBJECTIVE: To evaluate the safety and efficacy of AM-125 nasal spray (intranasal betahistine) in the treatment of surgery-induced acute vestibular syndrome (AVS). STUDY DESIGN: Prospective, double-blind, randomized, placebo-controlled exploratory phase 2 study with dose escalation (part A) followed by parallel dose testing (part B); open-label oral treatment for reference. SETTING: Twelve European study sites (tertiary referral centers). PATIENTS: One hundred and twenty-four patients 18 to 70 years old undergoing surgery for vestibular schwannoma resection, labyrinthectomy or vestibular neurectomy with confirmed bilateral vestibular function presurgery and acute peripheral vertigo postsurgery. INTERVENTIONS: AM-125 (1, 10, or 20 mg) or placebo or betahistine 16 mg p.o. t.i.d. for 4 weeks, starting 3 days postsurgery; standardized vestibular rehabilitation. MAIN OUTCOME MEASURES: Tandem Romberg test (TRT) for primary efficacy, standing on foam, tandem gait, subjective visual vertical and spontaneous nystagmus for secondary efficacy, Vestibular Rehabilitation Benefit Questionnaire (VRBQ) for exploratory efficacy; nasal symptoms and adverse events for safety. RESULTS: At treatment period end, mean TRT improvement was 10.9 seconds for the 20-mg group versus 7.4 seconds for the placebo group (mixed model repeated measures, 90% confidence interval = 0.2 to 6.7 s; p = 0.08). This was corroborated by nominally higher frequency of complete spontaneous nystagmus resolution (34.5% vs. 20.0% of patients) and improvement in the VRBQ; the other secondary endpoints showed no treatment effect. The study drug was well tolerated and safe. CONCLUSIONS: Intranasal betahistine may help accelerate vestibular compensation and alleviate signs and symptoms of vestibular dysfunction in surgery-induced AVS. Further evaluation in a confirmatory manner appears warranted.

The otologic approach in the management of posterior petrous surface meningiomas.

PURPOSE: Report our experience in the management of posterior petrous surface meningiomas (PPSMs), and identify features that affect hearing, facial nerve (FN) function, and control of the disease. METHODS: Retrospective case series of 131 patients surgically managed for PPSMs. FN status, hearing and tumour radicality were assessed and compared between patients with tumours of different locations (Desgeorges classification) and internal auditory canal involvement (IAC). RESULTS: At the time of surgery 74.8% of patients had a hearing loss. Hearing was mostly unserviceable in tumors attached to the meatus. Pure tone audiometry did not correlate to IAC extension, while speech discrimination scores were statistically worse when the tumor occupied the IAC (unpaired t test, p = 0.0152). Similarly, extrameatal tumors undergoing removal by otic preserving techniques maintained postoperative hearing, whereas hearing worsened significantly in tumors involving the IAC (paired t test, p = 0.048). The FN was affected preoperatively in 11.4% of cases. Postoperative FN palsy was significantly correlated to the IAC involvement (Fisher's exact test, p = 0.0013), while it was not correlated to tumor size. According to the Desgeorges classification, a postoperative FN palsy complicated the majority of anteriorly extending tumors and, two-fifths of meatus centred tumors. 75% of posterior located tumors had a postoperative FN grade I HB. CONCLUSIONS: Since the involvement of the IAC by the tumor affects both hearing and FN function, the IAC is of primary importance in PPSMs and should be studied and addressed as much as the tumor location in the CPA.

Surgical Labyrinthectomy and Cochlear Implantation in Menière's Disease.

OBJECTIVE: The aim of this study was to analyze the results of labyrinthectomy and cochlear implantation (CI) on hearing, vertigo, and tinnitus and evaluate the adequacy of labyrinthectomy and CI for the treatment of end stage Menière's Disease (MD). STUDY DESIGN: Retrospective case review. SETTING: Tertiary referral center. PATIENTS: Charts of 22 patients undergoing labyrinthectomy and CI in the same ear for intractable vertigo and hearing loss with both preoperatory and postoperatory documentation available, were reviewed. INTERVENTION(S): Therapeutic. MAIN OUTCOME MEASURE(S): Auditory outcomes were assessed with pure tone and speech audiometry, and compared with the preoperatory audiometric evaluation. Dizziness was graded according to the Dizziness Handicap Inventory Questionnaire (DHI). Tinnitus outcomes were assessed by the tinnitus handicap inventory (THI). RESULTS: Post-CI pure tone average had a statistically significant improvement (p = 0.035, paired t test). Speech audiometry resulted in a non-statistically significant speech discrimination score variation (p = 0.056, paired t test). Postoperatory THI had a statistically significant variation (p = 0.0001, paired t test). Sixty seven per cent of the patients had complete resolution of the vestibular symptoms in their operated ear, however, patients over 70 years old had significantly more failures as evinced by the postoperative DHI (p = 0.0109, Fisher's exact test). CONCLUSIONS: Patients affected by end stage MD or secondary MD, with vertigo and severe hearing loss can successfully undergo labyrinthectomy and CI. Caution should be reserved in elderly patients for a risk of persistent instability. The CI confers significant benefit in hearing rehabilitation and tinnitus suppression.

Bone anchored hearing implants without skin thinning: the Gruppo Otologico surgical and audiological experience.

To investigate the surgical and audiological outcomes of an installation of a bone-anchored hearing system (BAHS) procedure without tissue reduction using Ponto implants and abutments. Retrospective consecutive case series. Forty-nine patients, 18 years or older and eligible for treatment with a bone-anchored hearing system with tissue preservation surgery, were included in the study. Following a systematic scheme for medical outcomes, we collected the data regarding surgical intervention, quality of life (GBI), skin and soft tissue reactions (Holgers grading system), pain and numbness (VAS). Hearing performance (aided thresholds and speech recognition in noise) was recorded in 20 patients. No implants were lost, skin, and soft tissue reactions were mild in 96 % of the all visits. Quality of life (GBI) generally improved in the aided condition compared to prior to implantation. Audiologically, 100 % of the 20 patients examined showed improvement of speech reception and sound field thresholds comparing aided to unaided. An average improvement of 33 dB on PTA was recorded. The study, presenting data on a large population, treated with tissue preservation and modern titanium implants, shows that this treatment is a viable solution that results in fewer complications, high degree of predictability and good audiological results.

The long-term outcomes of wait-and-scan and the role of radiotherapy in the management of vestibular schwannomas.

OBJECTIVE: To analyze the growth characteristics in patients assigned to wait and scan in vestibular schwannomas (VSs) during long-term follow-up. BACKGROUND: The wait-and-scan policy and radiotherapy (RT) are conservative management strategies for VSs. A better insight into the natural history of the tumor and growth patterns is quintessential in planning optimal management. METHODS: The charts of 576 patients with unilateral sporadic VSs who were assigned to wait and scan at our center from 1986 to 2013 were reviewed. A systematic review of radiosurgical literature was done and compared with results of wait and scan. RESULTS: The overall mean follow-up was 36.9 ± 30.2 months. One hundred fifty-four patients with a 5-year follow-up were analyzed separately for patterns of tumor growth. Varied combinations of growth patterns were observed. Eighty-four (54.5%) tumors showed no growth throughout 5 years, 12 (7.8%) showed slow growth throughout 5 years, 2 (1.3%) tumors showed fast growth throughout 5 years. A total of 134 tumors (87%) showed favorable growth patterns for wait and scan. When the results of wait and scan were compared with those of RT, it pointed to the possibility that at least a portion of control of tumor by RT could be attributed to the natural course of the tumor. CONCLUSION: The wait-and-scan modality is ideal for management of VSs in the elderly population and also in younger patients with intrameatal tumors. Considering the fact that a large percentage of tumors do not require any form of treatment, the role of RT in VSs needs to be reinvestigated.

Salivary gland choristoma of the middle ear.

Choristoma of the middle ear is a rare condition characterized by the presence of normal salivary gland tissue in the middle ear space. Salivary gland choristomas are benign lesions that are frequently associated with ossicular chain and facial nerve anomalies. Total surgical excision is indicated when there is no risk of damaging the facial nerve. We describe a new case of salivary gland choristoma of the middle ear, and we discuss the etiology, histologic features, and management of such lesions. Our patient was a 22-year-old woman in whom we surgically removed a whitish retrotympanic mass. Intraoperatively, we also detected an ossicular chain malformation. Histologic examination of the choristoma revealed the presence of salivary gland tissue. Furthermore, the lesion contained an extensive and previously undescribed component: a well-defined pseudostratified respiratory-type epithelium, similar to that of a normal eustachian tube. Ten months after removal of the choristoma, we surgically repaired the ossicular chain anomalies. No recurrence was noted on follow-up.

The role of subtotal petrosectomy in cochlear implant surgery--a report of 32 cases and review on indications.

OBJECTIVE: To report and review 32 cases of subtotal petrosectomy (SP) in cochlear implant (CI) surgery and to define the indications and contraindications for this procedure. STUDY DESIGN: Retrospective case review + case reports. SETTING: Tertiary skull base center. PATIENTS: Cochlear implant database: 32 subtotal petrosectomies in 31 patients. INTERVENTIONS: Subtotal petrosectomy with blind sac closure of the external auditory canal, closure of Eustachian tube, and abdominal fat obliteration in combination with cochlear implantation. RESULTS: Indications for SP in CI surgery were as follows: chronic otitis media (n = 4), previous radical cavity (n = 13), previous subtotal petrosectomy (n = 4), ossification of the cochlea (n = 5), malformation of the inner ear (n = 2), and temporal bone fracture (n = 4). One patient was simultaneously bilaterally implanted; 2 cases were revisions. All procedures were performed in 1 stage. In 2 cases, complications were encountered (6%), one of which lead to reoperation (3%). None of the patients was explanted. CONCLUSION: Subtotal petrosectomy combined with cochlear implantation is a procedure required in specific situations and lowers the risk of repetitive ear infections, CSF leakage, and meningitis by closing off all connection with the external environment. Additionally, it gives excellent visibility and access in difficult anatomy or in drill-out procedures. The complication rate of 6% is comparable with normal cochlear implantation. Preservation of residual hearing can be considered the only absolute contraindication as an open external meatus is necessary for use of electroacoustic stimulation. Risks of the SP+CI procedure are infection of the abdominal fat, breakdown of the blind sac closure, and entrapped cholesteatoma. Follow-up with CT imaging is therefore mandatory.

The use of intratympanic gentamicin in patients with vestibular schwannoma and disabling vertigo.

OBJECTIVE: To document the effect of intratympanic gentamicin as treatment of disabling vertigo secondary to a vestibular schwannoma in elderly patients. PATIENTS: Four elderly patients with a vestibular schwannoma, with an extrameatal diameter of less than 1 cm, experiencing disabling vertigo and followed a wait-and-scan policy. INTERVENTION: Intratympanic injection of gentamicin. MAIN OUTCOME MEASURES: Subjective improvement of quality of life and audiologic and vestibular assessment. RESULTS: We obtained a subjective improvement in the quality of life for all the 4 patients. In fact, disabling vertigo disappeared in all cases; 3 patients recovered their posttreatment unsteadiness after a period of vestibular rehabilitation, whereas one of them complained of persistent unsteadiness. The hearing remained unchanged in 3 patients, whereas in one, the pretreatment severe sensorineural hearing loss progressed to anacusis. CONCLUSION: This treatment represents an additional option in patients with small not-growing tumor affected by vestibular symptoms to be combined with a wait-and-scan policy.

Congenital mastoid cholesteatoma: case series, definition, surgical key points, and literature review.

OBJECTIVES: We evaluate 3 new cases of congenital cholesteatoma confined to the mastoid process, and compare them with cases presented in the literature in order to better define this rare lesion. METHODS: We performed a retrospective chart analysis of all congenital cholesteatomas treated surgically in a tertiary referral and skull base center. We performed a complete analysis (history, radiologic, and surgical) of all patients with congenital cholesteatoma confined to the mastoid process; we then performed a literature review and compared our findings with the presented cases. RESULTS: The results of preoperative imaging were in line with the surgical findings. The most important surgical issue in this type of lesion was the management of the sigmoid sinus and the jugular bulb. Half of the cases previously reported in the literature appeared not to fulfill the definition criteria of a congenital cholesteatoma of the mastoid process. CONCLUSIONS: Congenital cholesteatoma confined to the mastoid process is a rare lesion, and is even more exceptional upon critical review of the literature. Symptoms are often lacking or nonspecific, and although cases have a congenital origin, the diagnosis often is not made until adulthood. A combined congenital cholesteatoma group with middle ear and mastoid features seems to fill in the gap in the definition. Management of the sigmoid sinus and the jugular bulb is the most demanding surgical key point.