Cochlear Implant Device Failures Falling Under the 2020 FDA Voluntary Field Corrective Action: A Systematic Review and Meta-analysis.

OBJECTIVE: To compare the rate of device failure for those cochlear implants (CIs) involved in the 2020 Food and Drug Administration (FDA) voluntary field corrective action (VFCA). DATABASES REVIEWED: Medline, Embase, and Scopus. METHODS: A systematic review was performed according to the PRISMA guidelines. Publications reporting institutional experiences with implants affected by the VFCA were included. Outcomes assessed included etiology of, rate of, and time to failure and pre-/post-device failure speech perception testing. All outcomes reported in at least two independent studies were included in a meta-analysis. RESULTS: Six studies met criteria for analysis. The overall pooled failure rate was 23.7% (95% CI, 11.6-38.4%). The pooled device, inconclusive, and medical failure rates were 21.5%, 0.2%, and 0.7%, respectively. Pediatric failure rates were higher than those of adults (46.9% [95% CI, 11.2-84.5%] versus 32.6% [95% CI, 8.2-63.7%]). WRS declined with primary implant failure (55.1% [95% CI, 48.0-62.1%] to 34.1% [95% CI, 30.2-38.0%]) but improved after reimplantation (34.1% [95% CI, 30.2-38.0%] to 50.1% [95% CI, 45.2-55.1%]). CONCLUSIONS: The rate of pooled reported failure for CIs falling under the 2020 VFCA in the literature thus far is 23.7%. The overwhelming majority of these failures were device related, the rates of which were higher in children. Speech perception improved significantly after reimplantation.

Cost-Effectiveness of Diffusion-Weighted Magnetic Resonance Imaging Versus Second-Look Surgery in Treating Cholesteatoma: A Modeling Study.

OBJECTIVE: To evaluate whether canal wall-up (CWU) tympanomastoidectomy with diffusion-weighted magnetic resonance imaging (DW-MRI) is a cost-effective method of treating cholesteatoma compared with CWU with second-look surgery. DESIGN AND SETTING: Cost-effectiveness analysis was conducted using a Markov state transition model. The simulation model adhered to the Panel Recommendations on Cost-Effectiveness in Health and Medicine established by the US Public Health Service. One-way and Monte Carlo probability sensitivity analyses were conducted for validation. INTERVENTIONS: Tympanomastoidectomy with DW-MRI versus tympanomastoidectomy with second-look surgery. MAIN OUTCOME MEASURES: Effectiveness and health utility were measured using quality-adjusted life years (QALYs). Costs were derived from Medicare reimbursement using the perspective of the payer. Probabilities for outcomes and complications were taken from existing literature. Cost-effectiveness was assessed using the incremental cost-effectiveness ratio. RESULTS: With base case analysis, the total cost was $15,069 when treated with CWU and second-look surgery versus $13,126 when treated with CWU and DW-MRI. The second-look treatment pathway yielded 17.05 QALYs, whereas the DW-MRI pathway yielded 16.91 QALYs in terms of health benefit accrued across the lifetime of the patient. The cost-effectiveness incremental cost-effectiveness ratio was $21,800/QALY. Using the conventional $50,000 willingness-to-pay threshold, second-look surgery was the more cost-effective approach 63.7% of the time by simulation. CONCLUSIONS: Both treatment pathways were found to be cost-effective, with second-look surgery incrementally cost-effective 63.7% of the time. Assumptions were validated by one-way and Monte Carlo probability sensitivity analysis. PROFESSIONAL PRACTICE GAP AND EDUCATIONAL NEED: There is ample variation in treatment pathways regarding usage of DW-MRI and second-look surgery for cholesteatoma. LEARNING OBJECTIVE: To evaluate the cost-effectiveness of DW-MRI and second-look surgery approaches, accounting for health-related quality-of-life outcomes and costs for the duration of the patient lifetimes. DESIRED RESULT: To inform the discussion on the treatment for cholesteatoma given emergent noninvasive technologies.Level of Evidence: Level III.Indicate IRB or IACUC: Exempt.

The Role of Lumbar Drains in the Perioperative Management of Primary Spontaneous Temporal Lobe Encephaloceles and Cerebrospinal Fluid Leaks.

OBJECTIVE: To examine the role of lumbar drains (LDs) in the success of spontaneous temporal cerebrospinal fluid (CSF) leak and encephalocele repair. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary academic health system. PATIENTS: Patients undergoing repair of spontaneous temporal lobe encephaloceles or middle fossa CSF leaks during years 2017 to 2023. INTERVENTIONS: Transmastoid, middle fossa craniotomy, or combination approaches to CSF leak repair. OUTCOME MEASURES: Failure rate, complication rate, length of stay (LOS), readmission. RESULTS: Sixty-nine patients were included, with a combination approach performed in 78.3%, transmastoid in 17.4%, and isolated middle fossa craniotomy in 4.3%. Mean body mass index was 33.2, mean bony defect size width was 6.51 mm, and defect locations included the epitympanum, antrum, mastoid, and petrous apex. Multilayer closure with three or more layers was performed in 87.0%. LD was used in 73.9% of cases for a mean duration 2.27 days and was associated with longer LOS (3.27 vs. 1.56 d, p = 0.006) but not with failure rate, complications, discharge destination, or readmission. Only one major complication occurred as a result of the drain, but low-pressure headache was anecdotally common. CONCLUSIONS: Use of LD in the repair of spontaneous CSF leaks and temporal lobe encephaloceles is associated with longer LOS but not failure rates or other admission-level outcomes.

Use of Soft Cervical Collar Improves Surgeon Ergonomics During Simulated Otologic Surgery.

OBJECTIVE: To determine whether surgeon use of a soft cervical collar during endoscopic and microscopic otologic surgery is feasible and impacts surgeon ergonomics as measured by inertial sensors. STUDY DESIGN: Prospective crossover trial. SETTING: US-based otolaryngology training program. PATIENTS: Otolaryngology residents and fellows. INTERVENTIONS: Therapeutic-use of a soft cervical collar during simulated otologic surgery. MAIN OUTCOME MEASURES: Time spent in high-risk angles of neck and back flexion and extension; average angle of neck flexion, extension, rotation, and lateral bending; validated assessment of neck pain; average daily phone use. RESULTS: Fifteen subjects met criteria for inclusion. Ten of 15 (67%) were male. Seven of 15 (47%) were postgraduate year 1-2. Seven of 15 (47%) reported a history of neck pain. None reported prior spinal steroid injections or surgery. Across all subjects, use of the soft cervical collar significantly reduced time spent in high-risk angles of neck flexion/extension during both endoscopic (56% vs. 35%, p < 0.05) and microscopic (60% vs. 32%, p < 0.05) otologic surgery. There was no effect on back flexion or extension. There was no difference in time spent in high-risk neck or back angles between endoscopic and microscopic surgery. Average angles of neck or back flexion, extension, lateral bending, and rotation were not significantly different for subgroups with more operative experience, increased phone use, perception of good posture, or history of neck pain. CONCLUSIONS: Use of a soft cervical collar during simulated otologic surgery significantly reduced time spent in high-risk neck positions. These data support feasibility of soft collar use during otologic surgery and hold promise for reduction in the high rates of neck pain reported by neurotologists. PROFESSIONAL PRACTICE GAP AND EDUCATIONAL NEED: Improving surgeon ergonomics for otologic surgery. LEARNING OBJECTIVE: To identify a therapeutic intervention to mitigate neck pain in surgeons caused by assumption of high-risk cervical neck flexion and extension. DESIRED RESULT: To demonstrate that use of a readily available soft cervical collar reduces risk of neck pain in otologic surgeons. LEVEL OF EVIDENCE: II. INDICATE IRB OR IACUC: Exempt.

Management of phaeochromocytoma and paraganglioma in patients with germline SDHB pathogenic variants: an international expert Consensus statement.

Adult and paediatric patients with pathogenic variants in the gene encoding succinate dehydrogenase (SDH) subunit B (SDHB) often have locally aggressive, recurrent or metastatic phaeochromocytomas and paragangliomas (PPGLs). Furthermore, SDHB PPGLs have the highest rates of disease-specific morbidity and mortality compared with other hereditary PPGLs. PPGLs with SDHB pathogenic variants are often less differentiated and do not produce substantial amounts of catecholamines (in some patients, they produce only dopamine) compared with other hereditary subtypes, which enables these tumours to grow subclinically for a long time. In addition, SDHB pathogenic variants support tumour growth through high levels of the oncometabolite succinate and other mechanisms related to cancer initiation and progression. As a result, pseudohypoxia and upregulation of genes related to the hypoxia signalling pathway occur, promoting the growth, migration, invasiveness and metastasis of cancer cells. These factors, along with a high rate of metastasis, support early surgical intervention and total resection of PPGLs, regardless of the tumour size. The treatment of metastases is challenging and relies on either local or systemic therapies, or sometimes both. This Consensus statement should help guide clinicians in the diagnosis and management of patients with SDHB PPGLs.

Immediate Improvement in Subjective Visual Vertical and Disequilibrium Predicts Resolution of Benign Paroxysmal Positional Vertigo Following Single Canalith Repositioning Maneuver.

Objective: To evaluate whether immediate post-canalith repositioning maneuver (CRM) vestibular changes are predictive of benign paroxysmal positional vertigo (BPPV) resolution. Study Design: Retrospective cohort study. Setting: Tertiary referral center. Patients: Adults (n = 27) with posterior canal BPPV. Interventions: Single CRM with Frenzel goggles. Main Outcome Measures: The Visual Analog Scale (VAS) for disequilibrium, the subjective visual vertical (SVV), the subjective visual horizontal (SVH), and the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) were administered pre- and immediately following single CRM. Dix-Hallpike was performed 1-3 weeks after CRM to assess for BPPV resolution. Pre- and post-treatment vestibular assessments were compared between groups to determine if post-CRM vestibular changes could predict BPPV resolution. Results: The change in VAS score following CRM treatment was statistically different between patients who responded to CRM treatment (n = 15) and those who did not (n = 12), (-0.07 points versus -2.40 points, respectively; P = 0.03). Likewise, a significantly greater improvement in SVV score was observed for CRM responders compared with CRM nonresponders (0.92° versus -0.06°, respectively; P = 0.02). Change in SVH and mCTSIB scores did not differ significantly between groups. Additionally, patient age was found to predict outcome of CRM treatment, with older patients more likely to experience persistent BPPV (P ≤ 0.01). Conclusions: Immediate improvement in VAS and SVV scores following CRM may be useful in predicting resolution of BPPV and may assist in directing the timing and need for future interventions. Younger age may have a favorable predictive value for improvement following single CRM.