Actigraphy measures show sleep improvement after parathyroidectomy for primary hyperparathyroidism.

IMPORTANCE: The symptoms of primary hyperparathyroidism are often subtle, such as fatigue, mood changes, and sleep disturbances. After parathyroidectomy, patients often report improvement in sleep and mood; however, objective data supporting these improvements is lacking. OBJECTIVE: This prospective study uses standard measures to objectively and subjectively assess sleep in patients with primary hyperparathyroidism before and after parathyroidectomy. DESIGN: A longitudinal prospective study was conducted over three one-week-long periods: pre-parathyroidectomy, 1-week post-parathyroidectomy, and three months post-parathyroidectomy. During each time point, patients wore an actigraphy device, recorded a sleep diary, and completed the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and Depression Anxiety Stress Scale (DASS). Statistical analysis was performed using repeated measures models to compare the average measures among the three time points and test for trends over time. SETTING: Single institution, tertiary care center. PARTICIPANTS: Patients with primary hyperparathyroidism from ages 18 to 89 years old. EXPOSURE: Parathyroidectomy between September 2020 and January 2024. MAIN OUTCOMES AND MEASURES: Actigraphy data, consensus sleep diary, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Depression Anxiety Stress Scales - 21 Items (DASS). RESULTS: Thirty-six patients were enrolled, and 34 patients completed the study. Actigraphy data showed a significant negative trend in average sleep latency (p = 0.045) and average time in bed (p = 0.046). Sleep diary data showed additional differences in the number of awakenings (p = 0.002), wake after sleep onset (p < 0.001), sleep quality (p < 0.001), and sleep efficiency (p = 0.02) among the three time points and/or as a significant negative trend. PSQI and ISI scores were significantly different among the three time points (p = 0.002 and p < 0.001, respectively) and also declined significantly over time (p = 0.008 and p = 0.007, respectively). DASS depression, anxiety, and stress scores were significantly different among the three time points (p < 0.001, p = 0.01, and p < 0.001, respectively), and stress also declined significantly over time (p = 0.005). CONCLUSION AND RELEVANCE: This study represents the most extensive prospective study demonstrating objective and subjective sleep and mood improvement in patients with primary hyperparathyroidism after parathyroidectomy.

Auditory brainstem implants: an analysis of adverse events in the MAUDE database.

OBJECTIVE: Auditory Brainstem Implants (ABI) are used to restore hearing in patients lacking appropriate cochlear anatomy and/or cochlear nerve. The objective of this study was to examine the Manufacture and User Facility Device Experience (MAUDE) database to analyze adverse events. STUDY DESIGN: This is a study of a multi-institutional database maintained by the US FDA. SETTING: A database analysis was performed via collaboration of multiple clinicians at tertiary referral centers. METHODS: The MAUDE database was queried for Medical Device Reports (MDRs) relating to ABIs. MDRs were identified using the advanced search term "Implant, Auditory Brainstem" and reviewing all reports with the basic search term "Brainstem Implant". All collected reports were individually reviewed. RESULTS: A total of 265 individual patient reports were reviewed, of which 55 reports met inclusion criteria. Reports regarding audiologic outcome included failure to provide hearing benefit (n = 27), implant failure/device malfunction (n = 10), and device non-use (n = 6). Postoperative complications included local skin infection (n = 3), CSF leak (n = 3), elevated ICP (n = 1), surgical site dehiscence (n = 1), swelling (n = 1), seroma formation requiring drainage (n = 1), and meningitis (n = 2). Two patients had dislodged magnets during 1.5 Tesla MRI acquisition. There were 35 instances of full explantation of the device and 1 partial removal; 13 patients had a new device implanted following explantation. CONCLUSIONS: Poor hearing results, device failure, and non-use were commonly reported causes for explanation in this analysis. This information can aid physicians in counseling patients and family members and managing device expectations.

Diagnosis and management of facial nerve palsy secondary to granulomatosis with polyangiitis - A systematic review.

OBJECTIVE: Granulomatosis with polyangiitis is associated with otolaryngologic complaints in 70-95 % of cases, with the most common being serous otitis media. In rare cases, patients may experience facial nerve palsy in conjunction with otologic or nasal symptoms; and, often, initially present to an otolaryngologist. It is important for healthcare professionals to be able to recognize the nuisances of facial nerve palsy as a potential presentation of granulomatosis with polyangiitis. STUDY DESIGN: Systematic review. METHODS: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Protocol, PubMed and MED-LINE Databases were queried for articles published from January 2007 to December 2022 describing facial nerve palsy in the context of Granulomatosis with polyangiitis, formerly known as Wegener's Granulomatosis. The keywords included "facial nerve palsy", "facial palsy", "granulomatosis with polyangiitis", "Wegener's granulomatosis", "ANCA positive" in the title/abstract. All full-text articles available in English were screened, including single case presentations. Abstracts, commentaries, and publications deemed outside the scope of our study aims were excluded from review. After removal of duplicate articles, a total of 85 articles were screened. After applying inclusion and exclusion criteria, 14 articles were included in the review. RESULTS: There were a total of 28 reports of facial nerve palsy in the literature in patients who were eventually diagnosed with granulomatosis with polyangiitis. The patients' ages ranged from 14 to 68 years old. None of the patients had been previously diagnosed with GPA, and a majority of them presented initially with other otologic symptoms. Hearing loss was reported in 24 patients (86 %), otalgia was present in 11 patients (39 %), and otorrhea was present in 6 patients (21 %). Bilateral facial paralysis was reported in 10 patients in the literature (36 %). In total, 16 patients underwent surgery for facial paralysis: 6 tympanomastoidectomies, 4 mastoidectomies, 2 explorative tympanotomies. Surgery was generally considered ineffective in resolving facial weakness. All patients ended up receiving some combination of steroids and immunosuppressant, most commonly prednisolone and cyclophosphamide or rituximab, which was eventually transitioned to azathioprine for maintenance. Unlike auditory thresholds, which remained decreased in two patients, all patients recovered facial function following appropriate medical treatment of their vasculitis. CONCLUSIONS: Facial nerve paralysis in patients with granulomatosis with polyangiitis is a rare but treatable phenomenon. In patients with intractable otitis media, unresolving facial palsy, or a combination of otologic issues, it is important to consider GPA as a possible source. The prognosis for facial function appears to be excellent in patients who undergo appropriate treatment for vasculitis, but further studies are needed for confirmation.

Nasal Epistaxis Balloons: A Comprehensive MAUDE Database Analysis.

BACKGROUND: While nasal epistaxis balloons are generally seen as safe and routinely utilized by both surgical and nonsurgical providers, the complication profile related to this type of device has not been well defined. OBJECTIVE: The objective of this study was to utilize the FDA MAUDE (Manufacturer and User Facility Device Experience) database to better assess adverse events (AE) related to use of nasal epistaxis balloons. Reports were individually tabulated and events were categorized with special attention to AEs. METHODS: The FDA MAUDE database was queried for all medical device reports (MDR) related to nasal epistaxis balloon devices from January 2012 to November 2022. RESULTS: 19 MDRs met inclusion criteria. 5 MDRs were classified as device related (26.3 %); two events were reported for balloon leak and deflation, two events were reported for device breakage, and one device related event was unknown. 14 MDRs (73.7 %) were classified as patient related. Two documented MDRs were patient deaths due to exsanguination. Additional serious AEs included balloon ingestion and subsequent small bowel perforation (n = 1), cerebrospinal fluid leak (n = 1), skull base violation and intracranial placement of the device (n = 1), and respiratory distress (n = 3). CONCLUSION: Though epistaxis control with nasal balloons is generally seen as a safe procedure, there have been several concerning AEs reported. While two reports of death due to exsanguination were the most severe AEs, multiple other life-threatening AEs were also documented. Increased awareness of associated complications can be used to better counsel patients during the informed consent process as well as providers in their clinical decision making.

Eustachian Tube Balloon Dilation: A Comprehensive Analysis of Adverse Events.

BACKGROUND: Eustachian tube balloon dilation (ETBD) has been Food and Drug Administration (FDA) approved for refractory Eustachian tube dysfunction since 2016. While ETBD is generally seen as safe, the complication profile has not been well defined. OBJECTIVE: The objective of this study was to utilize the FDA manufacturer and user facility device experience (MAUDE) database to better assess adverse events (AE) related to ETBD. METHODS: This is a study of a multiinstitutional database maintained by the U.S. FDA. A database analysis was performed via the collaboration of multiple clinicians at tertiary referral centers. The FDA MAUDE database was queried for all medical device reports (MDR) related to ETBD devices from January 2012 to November 2022. Eighty-eight unique MDR were identified, 16 of which met inclusion criteria. RESULTS: Three MDRs were classified as device-related (18.8%); none resulted in an AE. Thirteen MDRs (81.3%) were patient-related; all were classified as AEs. The most common AE was postoperative subcutaneous emphysema (n = 6, 46.2%). Of the patients with subcutaneous emphysema, there was a wide range of severity. The most severe AE (n = 1, 6.3%) was postoperative stroke secondary to carotid artery dissection. CONCLUSION: Though ETBD is generally seen as a safe procedure, there have been several concerning AEs reported to date. Increased awareness of ETBD complications can serve as a primer for improved patient education and counseling during the informed consent process and aid surgeons in clinical decision-making. Future studies with standardized reporting protocols are warranted to create a central registry for ETBD.

Otologic use of porcine small intestinal submucosal graft (biodesign): A MAUDE database review.

OBJECTIVE: To review and summarize reported adverse events related to the use of porcine small intestine submucosal grafts (Biodesign™) in otologic procedures. STUDY DESIGN: Retrospective cross-sectional analysis. SETTING: Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. MATERIAL AND METHODS: The MAUDE database was queried for all medical device reports (MDR) related to otologic use of Biodesign™ (Cook Medical, Bloomington, IN) from January 2016 to November 2022. Adverse events (AEs) were identified by reviewing all reports with the basic search term "Biodesign" and "Biodesign, Otologic". Reports were individually reviewed and categorized with special attention to AEs. RESULTS: A total of 500 reports were reviewed. Since FDA approval of Biodesign™ in 2016, there have been 5 adverse events reported for use of Biodesign™ during otologic surgery (tympanoplasty, n = 3; stapes surgery, n = 2). All reported events described patient injury, and all cases required at least one revision surgery. Four cases described significant foreign body inflammatory reactions. Complications included hearing loss (n = 3), severe otalgia (n = 2), persistent perforation (n = 2), vertigo (n = 2), and facial paralysis (n = 1). CONCLUSION: The use of porcine small intestinal submucosal graft has been thought to be a safe and effective option for otologic surgery, with the advantage of availability without graft harvest in minimally invasive endoscopic surgery. However, foreign body or granulomatous reactions have been documented and should be considered prior to its use in otologic surgery.

Is there a role for Eustachian tube balloon dilation in pediatric patients with refractory Eustachian tube dysfunction?

BACKGROUND: Eustachian tube dysfunction (ETD) is common in children. Over the past decade, eustachian tube balloon dilation (ETBD) has become a more widespread treatment for this condition. Data has been encouraging in the adult population, but data among the pediatric population has been sparser. This comprehensive review aims to assess current evidence for ETBD in pediatric patients. REVIEW: Studies relevant to ETBD in the pediatric population were identified by utilizing the PubMed MEDLINE database. While multiple retrospective studies were found, this search yielded two systematic reviews focused on the pediatric population as the highest level of evidence assessing ETBD in children. There was overlap of included studies, but each review contained a unique set of studies. These reviews found that ETBD was safe in children. BEST PRACTICE SUMMARY: Overall, ETBD appears safe and efficacious in children with refractory ETD. Future prospective trials confirming this conclusion are warranted. At this time, there appears to be a role for ETBD with or without ventilation tube placement in children with refractory ETD.

Systematic Review of Laryngeal Fractures and Trends in Operative Management.

Study Design: Systematic review of the literature. Objective: The goal of this study is to review the current literature on the trends in management of laryngeal fractures following trauma. Methods: Independent searches of the PubMed and MEDLINE databases were performed. Articles from the period of 1963 to 2020 were collected. All studies which described laryngeal fractures using the Boolean method and relevant search term combinations, including "Laryngeal", "Fracture", "Operative", and "Management" were collected. Results: A total of 588 relevant unique articles were identified for analysis. Of these, 24 articles were deemed appropriate for inclusion in the literature review. Due to variability in study design and outcome measures, formal synthesis of data in the form of a meta-analysis was not possible. Conclusions: Laryngeal fractures are rare traumatic injuries that require early identification and evaluation with complex management options. This comprehensive review aims to highlight the breadth of the topic with regard to presentation and clinical management. Though there remains no clear best practice for laryngeal fracture management, we review trends in clinical practice throughout the literature.

Postoperative Outcomes in Pediatric Septoplasty.

OBJECTIVE: Identify risk factors and perioperative morbidity for pediatric patients undergoing septoplasty. METHODS: The American College of Surgeons National Surgical Quality Improvement Program Pediatric (NSQIP-P) database was retrospectively queried to identify patients who underwent septoplasty (CPT 30520) for a diagnosis of deviated nasal septum (ICD J34.2) from 2018 to 2019. Outcomes analyzed include patient demographics, medical comorbidities, surgical setting, operative characteristics, length of stay, and postoperative outcomes. RESULTS: A total of 729 children were identified. Median age at time of surgery was 15.8 years, with most patients (82.8%) >12 years of age; no significant association was identified between age at time of surgery and adverse surgical outcomes. Overall, postoperative complications were uncommon (0.6%), including readmission (0.4%), septic shock (0.1%), and surgical site infection (0.1%). A history of asthma was found to be a significant risk factor for postoperative complications (P = .035) as well as BMI (P = .028). CONCLUSION: The 30-day postoperative complications following pediatric septoplasty in children reported in the NSQIP-P database are infrequent. Special considerations regarding young age, complex sinonasal anatomy, and surgical technique remain important features in considering corrective surgery for the pediatric nose and certainly warrant further investigation in subsequent studies.

Assessing Patient Barriers to Cochlear Implantation.

OBJECTIVE: Evaluate barriers that deter adult patients from following through with cochlear implantation. STUDY DESIGN: Retrospective chart review and phone survey. SETTING: Single tertiary referral center. PATIENTS: Between January 2019 and August 2021, 113 patients, without a previous cochlear implant (CI), were determined to be candidates for cochlear implantation. Thirty-eight (33.6%) patients deferred cochlear implantation. Survey response rate was 61.1% (22/36). INTERVENTION: None. MAIN OUTCOME MEASURES: Demographic, socioeconomic, otologic history, and comorbidity factors associated with deferment of cochlear implantation. Patient survey assessment of factors that had the greatest impact, rated on a scale of 1 to 10 (10 being the most impactful), on their decision to defer a CI. RESULTS: Out of the 113 patients who met inclusion criteria, 75 (66.3%) underwent cochlear implantation and 38 (33.6%) patients deferred. Comparing implanted versus deferred groups, there was no statistical difference in age (67.1 y versus 68.5 y; p = 0.690) or male sex (53.3% versus 57.9%; p = 0.692). The deferred group had higher mean neighborhood disadvantage state decile (5.3 versus 4.3; p = 0.064) and national percentile (73.0 versus 66.2; p = 0.106) scores, although neither were statistically significant. A greater proportion of the deferred group were not living independently at time of CI evaluation (13.2 versus 2.7%; p = 0.017). Fear of losing residual hearing was rated the highest among the survey respondents (mean rating of 5.1), followed by general medical health (4.9) and cost and financial concerns (3.6). CONCLUSION: The greatest concern among the patients was the fear of losing residual hearing. Spending greater time educating patients about the success and failure rates of cochlear implantation may reduce patient hesitancy with implantation.

Head trauma and Cochlear implant displacement - A systematic review.

OBJECTIVE: Cochlear implant (CI) migration due to head trauma is a rare complication, and there is limited data summarizing this topic. This review seeks to provide a more comprehensive understanding of risk factors, clinical presentations, diagnosis, and intervention strategies for traumatic CI displacement. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Protocol was followed using the PubMed and MED-LINE databases from 2000 to 2021, with manual cross-checks of reference lists of identified articles for additional relevant studies. The keywords used for database searches included "cochlear implant", "migration", "displacement", "extrusion" and "head trauma". All full-text articles available in English were screened, including single case presentations. Abstracts, commentaries, and publications deemed outside the scope of our study aims were excluded from review. RESULTS: After the removal of duplicate articles, a total of 152 articles were screened. After applying inclusion and exclusion criteria, 11 articles were included in the review. Due to heterogeneity of the available literature, a qualitative synthesis was employed to integrate results by identifying common themes among the relevant studies. CONCLUSIONS: The incidence of traumatic CI migration is extremely low and can be due to receiver-stimulator displacement, magnet displacement, or electrode extrusion. Migration occurred anywhere from 3 months to 26 years after implantation, suggesting that risk of migration from head trauma does not depend solely on time from implantation. There are several methods for repairing migrated CI, but there is limited data comparing operative techniques, specifically in the prevention of traumatic CI migration.

Trends in Facial Paralysis Management: A National Survey Study.

INTRODUCTION: Advances in operative management, minimally invasive procedures, and physical therapy have allowed for dramatic improvements in functional and cosmetic outcomes in patients with facial paralysis. Our goal was to evaluate the current trends and practice patterns in the diagnosis and management of facial paralysis by provider demographics. MATERIALS AND METHODS: An electronic questionnaire was distributed to members of the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS). Practice patterns in the diagnosis and treatment were compared by level of training (fellowship-trained facial plastic and reconstructive surgeon versus non-fellowship trained), practice type (academic and private), practice length, patient volume, and presence of a dedicated facial nerve clinic. The bivariate associations of the outcome variables and the stratification factors were analyzed using 2-way contingency tables and Fisher's exact tests. RESULTS: The survey was sent to 1129 members of the AAFPRS. The response rate was 11.7% (n=132). Most respondents were fellowship-trained surgeons (79%) in the academic setting (55%), and most have been in practice for more than 10 years (53%). Practice setting and patient volume were the factors most associated with significant variations in management, including the use of facial paralysis grading scales, photography/videography, patient-reported outcome metrics, as well as differences in both noninvasive and surgical management. CONCLUSION: Based on the present study, several physician demographic factors may play a role in choosing which diagnostic and treatment options are employed for facial paralysis, with practice setting and patient volume appearing to be the 2 variables associated with the most significant differences.

Headache Diagnosis in Children and Adolescents.

Pediatric headache is a common medical complaint managed across multiple subspecialties with a myriad of unique factors (clinical presentation and disease phenotype) that make accurate diagnosis particularly elusive. A thorough understanding of the stepwise approach to headache disorders in children is essential to ensure appropriate evaluation, timely diagnosis, and efficacious treatment. This work aims to review key components of a comprehensive headache assessment as well as discuss primary and secondary headache disorders observed in children, with a particular focus on clinical pearls and "red flag" symptoms necessitating ancillary diagnostic testing.

Utility of Temporal Bone Computed Tomography in Pediatric Emergency Medicine.

OBJECTIVE: Temporal bone computed tomography (CT) requires a relatively high radiation dose to produce high-resolution images required to define surgical anatomy. In the acute setting, the need for this detailed evaluation of temporal bone pathology may not be required for nonsurgical management and clinical decision-making. We performed a retrospective review of the clinical characteristics and subsequent management of children who underwent CT of the temporal bone with the goal of optimizing clinical decision-making and mitigating the risks of radiation exposure in children. METHODS: We included pediatric patients (<18 years of age) with International Classification of Diseases (9th or 10th revision) diagnoses consistent with otitis externa, otitis media, mastoiditis, head trauma, temporal bone fracture, and otalgia who were treated in the emergency department and underwent temporal bone CT from January 1, 2012-December 31, 2016. We collected data regarding the patients' presenting symptoms, physical exam findings, indications for imaging, radiographic findings, disposition, and operative intervention within 30 days of imaging. Features of the suspected mastoiditis group were compared between operative and non-operative patients. RESULTS: Over the four-year study period there were 96 temporal bone CTs. Most studies (70%) were associated with a subsequent inpatient admission. Common indications for imaging included evaluation of acute mastoiditis (55%) or trauma (41%). Of the 53 patients with concern for mastoiditis, 27 (51%) required otologic surgery. Two patients in the trauma group required surgical intervention, both for facial nerve decompression. In patients with suspected mastoiditis, mental status changes (P = 0.02), auricular proptosis (P = 0.05), and fluctuance (P = 0.02) were significantly more prevalent in the operative group; however, no other findings were significantly associated with operative intervention. CONCLUSION: Temporal bone CT is beneficial in guiding diagnosis and management of acute mastoiditis. We found that a majority of patients with suspected mastoiditis who underwent temporal bone CT ultimately required surgery or hospital admission. However, the potential for reduction in the use of CT still exists in this population. Fractures of the temporal bone typically do not require urgent operative intervention in the absence of complete facial nerve paralysis; thus, the utility of temporal bone CT in trauma evaluation may be limited.

A Novel Technique for Reconstruction of a Congenitally Absent Earlobe.

OBJECTIVE: Congenital anomalies of the external ear may present a reconstructive challenge, particularly when normal chondrocutaneous components of the auricle fail to develop. Our goal was to develop a novel technique for lobule reconstruction of a congenitally absent earlobe with photographic documentation of the technique. METHODS: Informed consent for perioperative photography and publication of case details was obtained. A postauricular, turnover flap with ipsilateral conchal cartilage grafting was performed to reconstruct the lobule, and a superiorly based, postauricular, rotation advancement flap was used to close the donor site defect. RESULTS: Perioperative photographs are included demonstrating technique and cosmetic results. CONCLUSIONS: Malformations rarely involve the lobule or lower third of the ear primarily. Literature regarding lobule reconstruction for congenital malformations is scarce. We present a novel technique for lobule reconstruction of a congenitally absent earlobe performed in a single stage that avoids a visible neck scar and allows for simultaneous conchal cartilage harvest. The technique demonstrated satisfactory cosmesis regarding contour and overall appearance and these results remained stable at 1-year follow up.

The Safety Profile of Liposomal Bupivacaine Use in Septorhinoplasty.

Objective: To evaluate the safety profile, including adverse drug reactions and operative complications, of liposomal bupivacaine (LB) use for local anesthesia during functional septorhinoplasty. Study Design: Retrospective review. Subject and Methods: A database query was conducted for patients >18 years of age who underwent septorhinoplasty from January 1, 2019, to August 1, 2020. Adverse drug reactions and postoperative outcomes were compared between patients who received locally administered LB and patients who received standard local anesthetic at the completion of the surgery. Results: A total of 95 cases were included in our data analysis. No significant differences were found in adverse reactions overall (6.3% vs. 3.1%, p = 0.51) or complications, including rate of infection (3.2% vs. 3.1%, p = 1), cartilage warping (1.6% vs. 0%, p = 1), graft resorption (0% vs. 0%, p = 1), septal hematoma (0% vs. 0%, p = 1), and need for revision surgery (4.8% vs. 3.1%, p = 1) between LB and control groups. Conclusion: LB demonstrated an acceptable safety profile when compared with standard local anesthetics during septorhinoplasty, with no significant difference in systemic or local adverse drug reactions or postoperative complications.

A Systematic Review of Surgical Techniques for Management of Severe Rhinophyma.

STUDY DESIGN: Systematic review of the literature. OBJECTIVE: The goal of this study is to review the current literature on severe rhinophyma requiring operative management for significant cosmetic deformity or nasal obstruction. We aim to provide a treatment algorithm for the various surgical techniques employed in the treatment of severe rhinophyma. METHODS: Independent searches of the PubMed and MEDLINE databases were performed. Articles from the period of 2010 to 2020 were collected. All studies which described surgical treatment of severe rhinophyma using the Boolean method and relevant search term combinations, including "rhinophyma," "severe," "operative" and "surgery" were collected. RESULTS: A total of 111 relevant unique articles met criteria for eligibility analysis. Of these, 85 articles were deemed inappropriate for the literature review due to exclusion criteria. The remaining 26 articles were included in the literature review. Due to variability in study design and outcome measures, formal synthesis of data in the form of a meta-analysis was not possible. CONCLUSIONS: Severe rhinophyma may present a reconstructive challenge to reestablish normal contour and patent nasal airway. Significant deformity necessitates surgical correction. The present article reviews the current literature and provides a summary and stepwise explanation of established surgical techniques for addressing the cosmetic and functional deficits these patients encounter.