Prospective >12 Months Outcomes After Vocal Fold Injection Medialization With Silk Microparticle-Hyaluronic Acid Material.

OBJECTIVE: Vocal fold injection medialization (VFIM) is widely used as an initial treatment for unilateral vocal fold paralysis (UVFP). Current practices employ materials that share the limitation of temporary clinical effect from variable resorption rates. A novel silk protein microparticle-hyaluronic acid-based material (silk-HA) has demonstrated cellular infiltration and tissue deposition that may portend a durable medialization effect. We report on ≥12 months outcomes after VFIM with silk-HA. METHODS: Prospective open-label study of patients with UVFP that elected treatment with VFIM with silk-HA. Blinded experts rated laryngeal stroboscopic exams. RESULTS: Seventeen patients with UVFP underwent VFIM with silk-HA. Twelve of the 17 patients have ≥12 months follow-up. Seven patients demonstrated durable treatment benefit ≥12 months after injection with median improvement of 19 (p = 0.0156) in VHI-10. There was no significant change in VHI-10 between 1 and 12 months for these patients. Blinded ratings indicated that 5/7 patients with sustained improvements in VHI-10 exhibited complete or touch glottal closure at 12 months. Two of the seven patients exhibited a small (<1 mm) glottal gap at 12 months. Seven patients experienced initial benefit with later regression 3-4 months after injection. CONCLUSION: VFIM with silk-HA can offer durable improvement in voice-related outcomes for UVFP past 12 months. A subset of patients treated with silk-HA experienced early loss of effect around 3-4 months postinjection. Clinical factors predictive of sustained treatment response to silk-HA injection require further exploration. LEVEL OF EVIDENCE: 3 Laryngoscope, 2023.

Assessment of Patients Receiving Short-Interval Botulinum Toxin Chemodenervation Treatment for Laryngeal Dystonia and Essential Tremor of the Vocal Tract.

Importance: The gold-standard treatment for laryngeal dystonia (LD) and essential tremor of the vocal tract (ETVT) is botulinum toxin (BoNT) chemodenervation. Although safe and effective, it is not curative, and periodic injections are required. Some medical insurance companies only cover injections at a 3-month interval, though some patients benefit from injections more frequently. Objective: To determine the proportion and characteristics of patients who receive BoNT chemodenervation treatment in intervals shorter than 90 days. Design, Setting, and Participants: This retrospective cohort study across 3 quaternary care neurolaryngology specialty practices in Washington and California recruited patients who underwent at least 4 consecutive laryngeal BoNT injections for LD and/or ETVT in the past 5 years. Data were collected from March through June 2022 and analyzed from June through December 2022. Exposure: Laryngeal BoNT treatment. Main Outcomes and Measures: Biodemographic and clinical variables, injection characteristics, evolution during the 3 interinjection intervals, and lifetime laryngeal BoNT treatment data were collected from patient medical records. Logistic regression was used to assess association to the short-interval outcome, defined as an average injection interval shorter than 90 days. Results: Of 255 patients included from the 3 institutions, 189 (74.1%) were female, and the mean (SD) age was 62.7 (14.3) years. The predominant diagnosis was adductor LD (n = 199 [78.0%]), followed by adductor dystonic voice tremor (n = 26 [10.2%]) and ETVT (n = 13 [5.1%]). Seventy patients (27.5%) received short-interval injections (<90 days). The short-interval group was younger than the long-interval group (≥90 days), with a mean (SD) age of 58.6 (15.5) years and 64.2 (13.5) years, respectively, and a mean difference of -5.7 years (95% CI, -9.6 to -1.8 years). There were no patient-related differences between the short- and long-interval groups in terms of sex, employment status, or diagnosis. Conclusions and Relevance: This cohort study demonstrated that while insurance companies often mandate a 3-month or greater interval for BoNT chemodenervation financial coverage, there is a considerable subset of patients with LD and ETVT who receive short-interval treatment to optimize their vocal function. Short-interval chemodenervation injections demonstrate a similar adverse effect profile and do not appear to predispose to resistance through antibody formation.

Fake drugs: Using Baseline Spectral Fingerprinting and a sorting algorithm to infer quality of medications.

An estimated 30-70% of available medications in low-income countries and conflict states are of low quality or counterfeit. Reasons for this vary but most are rooted in regulatory agencies being poorly equipped to oversee quality of pharmaceutical stocks. This paper presents the development and validation of a method for point-of-care drug stock quality testing in these environs. The method is termed Baseline Spectral Fingerprinting and Sorting (BSF-S). BSF-S leverages the phenomena that all compounds in solution have nearly unique spectral profiles in the UV spectrum. Further, BSF-S recognizes that variations in sample concentrations are introduced when preparing samples in the field. BSF-S compensates for this variability by incorporating the ELECTRE-TRI-B sorting algorithm, which contains parameters that are trained in the laboratory using authentic, proxy low quality and counterfeit samples. The method was validated in a case study using fifty samples that include factually authentic Praziquantel and inauthentic samples prepared in solution by an independent pharmacist. Study researchers were blinded to which solution contained the authentic samples. Each sample was tested by the BSF-S method described in this paper and sorted to authentic or low quality/counterfeit categories with high levels of specificity and sensitivity. In combination with a companion device under development using ultraviolet light emitting diodes, the BSF-S method is intended to be a portable and low-cost method for testing medications for authenticity at or near the point-of-care in low income countries and conflict states.

Local Reaction Causing Airway Compromise Following Vocal Fold Injection Augmentation with Carboxymethylcellulose.

OBJECTIVES: This case report aims to identify local allergic reaction as a rare complication of vocal fold injection augmentation with carboxymethylcellulose and discuss the management of airway swelling following this reaction. INTRODUCTION: Glottis insufficiency due to true vocal fold immobility is important to manage to reduce risk of aspiration and improve voice function. Vocal fold injection augmentation with carboxymethylcellulose is considered a safe and effective treatment for glottis insufficiency, commonly due to vocal fold immobility. METHODS: Retrospective medical records review and case report. RESULTS: We report a unique case of an adult female with vocal fold immobility that was treated with injection laryngoplasty using carboxymethylcellulose and subsequently developed a local reaction requiring intubation and tracheostomy placement. CONCLUSION: Otolaryngologists should be aware of this rare, but life-threatening complication and counsel patients accordingly when obtaining consent. If there are signs and symptoms of airway edema, the patient should be transferred to the ICU for airway watch, intravenous steroids, and possible intubation.

Opioid Sparing Multimodal Analgesia for Transoral Robotic Surgery: Improved Analgesia and Narcotic Use Reduction.

Objective: To compare postoperative pain scores and opioid consumption in patients after transoral robotic surgery (TORS). Study Design: Single institution retrospective cohort study. Setting: TORS was performed at a single academic tertiary care center. Methods: This study compared traditional opioid-based and opioid-sparing multimodal analgesia (MMA) regimens in patients with oropharyngeal and supraglottic malignancy after TORS. Data were obtained from the electronic health records from August 2016 to December 2021. The average postoperative pain scores and total opioid consumption in morphine milligram equivalents were calculated for postoperative days (PODs) 0 to 3. The secondary objectives were to quantify and characterize opioid prescriptions upon hospital discharge. Results: A total of 114 patients were identified for this study, 58 patients in the non-MMA cohort and 56 in the MMA cohort. Postoperative pain levels in the MMA cohort were statistically lower on POD 0 (p = 0.001), POD 1 (p = 0.001), and POD 3 (p = 0.004). Postoperative opioid consumption decreased significantly in the MMA cohort from 37.7 to 10.8 mg on POD 0 (p = 0.002), 65.9 to 19.9 mg on POD 1 (p < 0.001), 36.0 to 19.3 mg on POD 2 (p = 0.02), and 45.4 to 13.8 mg on POD 3 (p = 0.02). The number of patients discharged from the hospital with a prescription for narcotics was significantly lower in the MMA cohort (71.4%) compared with the non-MMA cohort (98.3%) (p < 0.001). Conclusion: Implementation of our MMA pain protocol reduced pain levels and narcotic consumption in the immediate postoperative period.

Adverse Events Associated With Image-Guided Sinus Navigation in Endoscopic Sinus Surgery: A MAUDE Database Analysis.

OBJECTIVE: The utilization of image-guided navigation during endoscopic sinus surgery (ESS) has increased significantly since its introduction. However, the most common associated complications are still unknown. This study describes and analyzes adverse events related to image-guided ESS. STUDY DESIGN: Cross-sectional analysis. SETTING: The Food and Drug Administration's 2018-2022 MAUDE database (Manufacturer and User Facility Device Experience). METHODS: The MAUDE database was searched for all reports on adverse events involving sinus navigation systems used in ESS from 2018 to 2022. Reported events were reviewed and categorized. RESULTS: During the study period, there were 1857 adverse events from 1565 reports, which were divided into device-related (n = 1834, 98.8%) and patient-related (n = 23, 1.2%) complications. The most common device-related complications were nonfunctionality of the system (n = 512, 27.9%), device imprecision (n = 427, 23.3%), and device sensing problems (n = 277, 15.1%). The most common patient-related complications were cerebrospinal fluid (CSF) leak (n = 14, 60.9%), intracranial injury (n = 4, 17.4%), and bleeding/hemorrhage (n = 3, 13.1%). Imprecision was associated with increased risk of navigation abortion by the surgeon (odds ratio, 1.50 [95% CI, 1.38-1.65]; P < .001) and increased risk of CSF leak (odds ratio, 16.5 [95% CI, 3.66-74.0]; P < .001) as compared with other device-related complications. CONCLUSIONS: The most commonly reported device- and patient-related adverse events associated with image-guided sinus navigation systems were device nonfunction, imprecision, device sensing difficulties, and CSF leak. When imprecise navigation occurred, there was an increased likelihood of CSF leak and navigation abortion by the surgeon. Health care providers should be mindful of these possible complications when electing to use image-guided sinus navigation during ESS.

Ultrasound-guided regional anesthesia: feasibility and effectiveness of teaching via telesimulation in Ethiopia.

BACKGROUND: Acute pain management in resource-poor countries remains a challenge. Ultrasound-guided regional anesthesia is a cost-effective way of delivering analgesia in these settings. However, for financial and logistical reasons, educational workshops are inaccessible to many physicians in these environments. Telesimulation provides a way of teaching across distance by using simulators and video-conferencing software to connect instructors and students worldwide. We conducted a prospective study to determine the feasibility of ultrasound-guided regional anesthesia teaching via telesimulation in Ethiopia. METHODS: Eighteen Ethiopian orthopedic and emergency medicine house staff participated in telesimulation teaching of ultrasound-guided femoral nerve block. This consisted of four 90-min sessions, once per week. Week 1 consisted of a precourse test and a presentation on aspects of performing a femoral nerve block, weeks 2 and 3 were live teaching sessions on scanning and needling techniques, and in week 4, the house staff undertook a postcourse test. All participants were assessed using a validated Global Rating Scale and Checklist. RESULTS: Participants were provided with a validated checklist and global rating scale as a pretest and post-test. The participants showed significant improvement in their test scores, from a total mean of 51% in the pretest to 84% in their post-test. CONCLUSIONS: Teaching ultrasound-guided regional anesthesia of the femoral nerve remotely via telesimulation is feasible. Telesimulation can greatly improve the accessibility of ultrasound-guided regional anesthesia teaching to physicians in remote areas.