Impact of elexacaftor/tezacaftor/ivacaftor CFTR modulator therapy on rates of endoscopic sinus surgery in cystic fibrosis.

BACKGROUND: Elexacaftor/tezacaftor/ivacaftor (ETI), a combination cystic fibrosis transmembrane receptor (CFTR) modulator, has demonstrated improved pulmonary outcomes in individuals with cystic fibrosis (CF). However, ETI's impact on functional endoscopic sinus surgery (FESS) remains unclear. METHODS: The TriNetX Analytics Research Network, consisting of 120 million global de-identified electronic medical records, was queried from 2012 to 2023 for subjects with CF who underwent sinus surgery.1 Patients on ETI prior to FESS (n = 6,056) were propensity score matched to control individuals with CF not on CFTR modulators (n = 37,906) and those on other FDA-approved CFTR modulators (tezacaftor/ivacaftor, lumacaftor/ivacaftor, and ivacaftor) (n = 2437) based on relevant factors. The primary outcome was the absolute risk reduction (ARR) of undergoing FESS. Secondary outcomes included ARR of CF-related pulmonary exacerbations and hospital admission from 0 to 6, 6 to 12, and 12 to 24 months following FESS. RESULTS: ETI use demonstrated a significant ARR for FESS when compared to CF patients not on CFTR modulators (2.12%; 95% confidence interval [CI] 1.5-2.75; p-value < 0.0001) and those on other CFTR modulators (4.7%; 95% CI 3.54-5.85; p-value < 0.0001). No significant differences occurred in secondary outcomes between ETI and non-CFTR modulator groups, except for reduced CF-related pulmonary exacerbations from 0 to 6 months post-FESS. Additionally, a significant reduction in pulmonary exacerbations was observed at all time points and hospital admissions within 6 months following FESS compared to those using other CFTR modulators. CONCLUSIONS: In a large dataset, CF patients on ETI demonstrated significantly reduced risk of FESS, pulmonary exacerbations, and hospital admission compared to patients not on CFTR modulators or those on other CFTR modulators, suggesting improved sinonasal disease and overall health status in CF.

Comprehensive Analysis of Adverse Events Associated With Hypoglossal Nerve Stimulators: Insights From the MAUDE Database.

OBJECTIVE: This study aims to examine the adverse events associated with hypoglossal nerve stimulator (HNS) implantation for treating obstructive sleep apnea (OSA), drawing data from the Manufacturer and User Facility Device Experience (MAUDE) database. We aim to provide a comprehensive and updated account of these adverse events. STUDY DESIGN: Retrospective analysis. SETTING: MAUDE Database review. METHODS: A retrospective analysis was performed on the MAUDE database to collect all HNS-related reports from May 2014 to December 2023. Variables collected included date of event, event description, nature of event, iatrogenic injuries, required interventions, and, if available, root causes. Each event description was analyzed to classify the adverse event, the postevent intervention, and device model number. RESULTS: Out of 1178 reports fulfilling the inclusion criteria, 1312 adverse events were identified. Common adverse events included infection (24.0%), pain (19.7%), and hematoma/seroma (10.2%). Approximately 83.1% of these adverse events necessitated medical and/or surgical intervention. The most frequent procedures included explantation (29.4%) and device repositioning (15.8%). Pneumothorax was reported in 50 cases, with 41 (82.0%) requiring a chest tube to be inserted. Three adverse events described overstimulation in the setting of magnetic resonance imaging (MRI) despite the implantation of MRI-compatible second-generation internal pulse generators. CONCLUSION: While HNS implantation has been established as a reliable intervention for OSA in cases of continuous positive airway pressure failure or intolerance, this study highlights several perioperative and postoperative difficulties and complications. Understanding these challenges is essential for refining surgical practices and enhancing patient consent processes, ultimately aiming to improve therapeutic outcomes.

Are There Hidden Adverse Events in Hypoglossal Nerve Stimulation: Comparing Social Media and a Federal Database.

OBJECTIVE: Hypoglossal nerve stimulation (HNS) can be an effective treatment for moderate to severe obstructive sleep apnea (OSA) in positive airway pressure (PAP) intolerant patients. To better understand patient experiences with HNS therapy, we explored reported events from HNS-related Facebook groups and the Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: A retrospective analysis of HNS-related Facebook posts from three groups pertaining to HNS therapy, from October 1, 2022 to October 1, 2023, was performed. Posts were analyzed for patient-reported adverse events. Concurrently, the MAUDE database was reviewed for HNS-related events during the same timeframe. RESULTS: From 737 Facebook posts, 132 (17.55%) adverse events were identified. Adverse events included pain (34.85%), stimulation discomfort (14.39%), lip weakness (6.82%) and issues related to lead tethering or tight leads around the neck (3.79%). Analysis of the MAUDE database found 428 adverse events, including pain (24.07%), lip weakness (0.44%), and lead tethering (1.64%). CONCLUSION: Facebook group members reported higher rates of lip weakness and lead tethering than recorded in the MAUDE database. These findings illustrate how diverse data sources, such as social media, can enhance our understanding of patient experiences and identify gaps in patient education with HNS therapy. LEVEL OF EVIDENCE: NA Laryngoscope, 2024.

COVID-19-related chemosensory changes: Findings from a prospective national database.

Objective: The aim of this study was to review findings from a large prospective national database of chemosensory disturbances associated with coronavirus disease 2019 (COVID-19) infection. Data Sources: The Virginia Commonwealth University Smell and Taste Center national database of COVID-19 chemosensory disturbances. Methods: A series of online surveys, first opened on April 10, 2020, was made accessible nationwide to any adult with sudden chemosensory dysfunction since January 2020. Participants received subsequent follow-up surveys 14 days, 1 month, 3 months, and 6 months after enrollment. An additional survey was sent to all participants on May 28, 2022 to assess long-term outcomes. Information pertaining to demographics, symptoms, comorbidities, treatments, and life impact was collected. Results: Of 363 participants who reported complete smell recovery, 51.2% recovered within 1 month, 70% within 3 months, and 79% within 6 months, while 8.8% took over 1 year to completely recover. Among all participants, 7.5% had no smell recovery. Positive predictors of recovery included age <40, male gender, and the presence of nasal congestion. Negative predictors included difficulty breathing and prior head injury. Many participants reported a decrease in quality of life and the presence of potential safety hazards associated with decreased smell loss. Conclusions: Most subjects with COVID-19-related chemosensory dysfunction recover, with the majority noting complete recovery within weeks of infection. Those aged over 40 years and female gender were associated with lower rates of recovery. A considerable number of participants reported significant impact on quality of life and safety.

Awareness campaigns for cochlear implants: Are we making an impact?

OBJECTIVE: This study aimed to determine if the major public awareness campaign for cochlear implants 'International Cochlear Implant Day' influenced national and international public interest as measured by internet search activity. METHODS: Weekly search volume data in the United States, Canada, Australia, Germany, United Kingdom, Brazil, India, Japan, and a 'Worldwide' group for the search topic 'cochlear implant' was collected from Google Trends over a 5-year period (2017-2021). The 'Campaign' window was defined as 1 week before, the week of, and 2 weeks after International Cochlear Implant Day (February 25th). 'Non-Campaign' weeks were considered any data outside the 'Campaign' window. RESULTS: Of the studied regions, the United States, United Kingdom, Australia, India, and 'Global' demonstrated a significant increase in internet search activity between 2017 and 2021. Although some individual years showed significant increases during the 'Campaign' period for Canada, Germany, Brazil, and Japan, none showed statistically significant increases over the 5-year period studied. CONCLUSION: Public awareness campaigns are recognized crucial elements to delivering effective healthcare, but their success varies worldwide. While data from Google Trends suggests that cochlear implant awareness campaigns can translate into increased internet searches, greater efforts can be made in select countries to improve public interest.

Considerations for Use of the MAUDE Database in Otolaryngology-Head & Neck Surgery Research.

The use of the US Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) to analyze adverse events linked to medical devices has grown in recent years. MAUDE facilitates post-market surveillance, contributing to the assessment of device performance and the identification of potential safety concerns. The database is instrumental not only for mandatory reporters such as manufacturers and healthcare facilities but also offers a platform for voluntary submissions from clinicians and patients, thus widening the scope of data collection. While the database offers valuable data, there are important limitations that must be understood in order to encourage appropriate interpretation of findings. This commentary highlights the major advantages and disadvantages of the MAUDE database, as well as describes possible areas for improvement in adverse event reporting.

Gun shot injuries to the temporal bone: Anatomic predictors of mortality.

PURPOSE: To explore anatomic predictors of mortality from gunshot wounds involving the temporal bone. METHODS: A retrospective search of radiology reports was performed for all patients with CT reports suggestive of gunshot wounds (GSW) to the TB (2000-2020). All cases were reviewed by the senior author to confirm injury to the temporal bone. Detailed demographic and radiographic data were collected. MAIN FINDINGS: A total of 120 patients met inclusion criteria. The majority of patients were male (n = 101) and the average age was 32.9. The squamosa was the most commonly involved subsite (n = 90), followed by the mastoid (n = 43). Squamosal entry site had the highest associated mortality (89.7 %). For those with known disposition, 65.8 % (79 of 120) expired on the same hospital admission. Inpatient otolaryngology consultation was noted in 18.3 % (n = 22) of patients, with poor outpatient follow-up. CONCLUSIONS: This series represents the largest survey of GSW to the temporal bone to date. Although associated mortality is high and outpatient follow-up poor, otolaryngologists should be aware of associated morbidities to facilitate both inpatient and subsequent outpatient management.

Vascular injury arising from lateral skull base fractures.

PURPOSE: Although uncommon, vascular injury can be seen in patients with lateral skull base fractures (LSBF). However, little is known about this potentially life-threatening comorbidity. The objective of this study is to better characterize the vascular injuries associated with temporal and lateral sphenoid bone fractures. BASIC PROCEDURES: Retrospective review of all patients with computed tomography angiography (CTA) performed specifically to evaluate for vascular injury following LSBF. In addition to patient demographics (age, gender, race), the mechanism of injury, the location of fracture(s), and the nature of vascular injury diagnosed by CTA was recorded. Two-way ANOVA was performed to determine if any variables were predictive of vascular injury. MAIN FINDINGS: From 2011 to 2021, 143 patients with 333 subsite fractures met inclusion criteria. Of all patients, 46 (32.2 %) had CTA evidence of at least one vascular injury, the most common type being venous thrombosis/filling defect (41.7 %). Evidence of vascular injury was unclear in 14 patients (9.8 %). Fractures most associated with vascular injury ranged from 0.7 % (otic capsule fractures) to 26.7 % (mastoid, lateral sphenoid fractures). Risk of vascular injury was no different between patients with single vs multiple fractures. There were no fracture locations that could reliably predict specific vascular injury. CONCLUSIONS: Over 40 % of all CTAs ordered following LSBF identified were suspicious for associated vascular injury. Yet fracture location and number cannot reliably predict vascular injury. Until such determinants can be better identified, clinicians should have a low threshold to obtain CTA to rule out associated vascular injury.