Disparities in the prevalence of self-reported dysphagia and treatment among U.S. adults.

OBJECTIVE: To assess sociodemographic differences in the prevalence of self-reported dysphagia and treatment and to identify barriers in access to care. STUDY DESIGN: Cross-sectional analysis. SETTING: National healthcare survey database. METHODS: The 2012 National Health Interview Survey was used to analyze adults who reported a swallowing problem in the prior 12 months. Associations of sociodemographic variables with dysphagia prevalence and treatment as well as access to care were determined by multivariate logistic regression. RESULTS: Among 235 million adults in the United States, 9.4 ± 0.3 million (4.0 % ± 0.1 %) adults (mean age 52.1 ± 0.6 years; 60.2 % female) reported swallowing problems, only 19.2 % ± 2.0 % of whom reported receiving treatment or therapy for their swallowing problem. In a multivariate model controlling for sociodemographic factors, female gender, older age, lower income level, public insurance status and unemployment were independently associated with increased odds of reporting dysphagia, while also associated with decreased odds of receiving treatment. Conversely, Black, Hispanic and other racial/ethnic minorities were less likely to report swallowing problems, but among those who did report dysphagia, non-white adults were more likely to receive treatment. Barriers leading to delayed care for women, low-income adults and adults with public or no health insurance included cost, not being able to get an appointment soon enough, limited office hours, inability to get through to an office by phone, lack of transportation, and long office wait times. CONCLUSION: Sociodemographic groups at higher risk for dysphagia are less likely to receive treatment. Targeted interventions are needed to address barriers to care. LEVEL OF EVIDENCE: IV.

Dysphagia as a Manifestation of Endocrine and Metabolic Disorders.

Dysphagia is a common manifestation of endocrine and metabolic diseases. Swallowing is a complex neuromuscular process, with an interplay of sensory and motor function, that has voluntary and involuntary control. Disruptions in any of these processes can cause significant dysphagia. Endocrine disorders and metabolic derangements are systemic conditions that affect multiple organ systems. They contribute to the development of neuropathies, myopathies, and motility disorders that lead to swallowing difficulty. Malnutrition and critical illness can lead to deconditioning and atrophy which can cause dysphagia, which in turn can lead to further malnutrition and deconditioning.

Safety of Nebulized Ciprodex for Postoperative Management of Tracheal Resection.

OBJECTIVE: Anastomotic complications after tracheal resection/cricotracheal resection (TR/CTR), such as granulation tissue formation, can lead to severe morbidity. The off-label use of nebulized ciprofloxacin-dexamethasone (Ciprodex) for granulation tissue prophylaxis has anecdotally been used after TR/CTR, especially in pediatric patients. However, its use in the adult population, and its safety and side effect profile post-TR/CTR has not been reported. This study aims to characterize the incidence of adverse side effects associated with nebulized Ciprodex in post-TR/CTR patients. METHODS: A retrospective review of all patients who underwent TR/CTR from June 2015 to July 2023 was performed. The use of nebulized Ciprodex (1 mL ciprofloxacin-dexamethasone 0.3%-0.1% otic suspension in 4 mL normal saline) while inpatient was evaluated. Potential side effects were defined as oral thrush, ageusia, arthralgia, and allergic reaction, and were recorded for all patients. RESULTS: Seventy-three patients underwent TR/CTR from June 2015 to July 2023. Of these, 53 (72.6%) had documented Ciprodex administration during their postoperative course. One (1.9%) patient reported at least one side effect, including one instance of skin rash (1.9%) and one instance of allergic reaction (1.9%). There were no other side effects attributed to Ciprodex use. CONCLUSIONS: The incidence of side effects related to the use of nebulized Ciprodex is felt to be minimal in post-TR/CTR. Although Ciprodex may have the potential to treat granulation tissue in the airway, further studies are needed to verify its efficacy and safety. LEVEL OF EVIDENCE: 4 Laryngoscope, 2024.

Development of a Novel Airway-Exchange Broncholaryngoscope.

OBJECTIVE: The purpose of this project was to develop a novel airway-exchange broncholaryngoscope (AEBLScope) to improve the efficiency and accuracy of airway-exchange procedures. METHODS: The AEBLScope was designed to combine a bronchoscope and airway-exchange catheter (AEC) into a single device and to reduce the blind placement of AECs. The prototype was constructed by modifying an existing distal-chip bronchoscope. A custom AEC was procured to fit concentrically over the flexible portion of the scope. The catheter was connected to the scope handpiece by a customized push-pull locking attachment. The AEBLScope was used to perform airway-exchange procedures with both tracheostomy and endotracheal tubes using two different airway models. Experimental procedures were recorded with still photography to evaluate the exchange of tubes and placement of AECs. RESULTS: In two airway models using the AEBLScope, both tracheostomy and endotracheal tubes were successfully exchanged on first-pass attempt, and AECs were accurately placed under visual guidance. CONCLUSION: The AEBLScope combines a bronchoscope and AEC into a single tool. Based on these first results, this novel scope has the potential to perform airway-exchange procedures more safely compared with standard procedures by increasing the accuracy of placement, decreasing procedural time, and reducing the morbidity and mortality that can occur from blind placement of AECs. LEVEL OF EVIDENCE: N/A Laryngoscope, 2024.

Experiences of Patients Living with Retrograde Cricopharyngeal Dysfunction.

OBJECTIVES: Retrograde cricopharyngeal dysfunction (RCPD) is a newly described condition resulting from failure of cricopharyngeal sphincter relaxation during periods of esophageal distension that results in the inability to burp. Patients' perspectives on symptom experiences, barriers to care, and treatment benefits were investigated. STUDY DESIGN: Qualitative semi-structured interviews were conducted with patients diagnosed with RCPD who had been treated with botulinum toxin injection into the cricopharyngeus muscle. Interview questions centered on their experience living with RCPD. Conventional content analysis was performed on interview transcripts. RESULTS: Thematic saturation was reached with 13 participants. All participants were diagnosed with RCPD by an otolaryngologist and underwent botulinum toxin injection into the cricopharyngeus muscle with or without dilation of the upper esophageal sphincter in the operating room. Participants described having no memories of ever being able to burp, and all started experiencing RCPD symptoms during adolescence. Patients with RCPD experienced increased social isolation, lost productivity, and worsened mental health. Unanimously, participants first learned about RCPD on social media. All patients were seen by physicians in non-otolaryngology specialties regarding their symptoms prior to learning about their RCPD diagnosis and undergoing treatment by an otolaryngologist. Dilation and chemodenervation resulted in complete resolution of RCPD symptoms for 84.6% of participants. Participants emphasized a desire for more health providers to learn about RCPD and the impact it has on quality-of-life. CONCLUSION(S): The lived experience of patients with RCPD significantly impacts quality of life and is often met with diagnostic barriers in the medical community. Although social media plays a significant role in increasing awareness of RCPD, physician education about the impact of RCPD is essential to improve diagnosis and treatment. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:2136-2143, 2024.

Timing of Complications in Open Airway Reconstruction.

OBJECTIVE: Tracheal resection (TR) and cricotracheal resection (CTR) are performed for patients with airway stenosis, tracheal tumor, and tracheoesophageal fistula. Post-operative complications include airway edema requiring reintubation, hematoma, anastomotic dehiscence, restenosis, and death. Although these complications and associated risk factors have been well described, the time where clinical suspicion should be highest post operatively has not been characterized. METHODS: Patients who underwent TR or CTR at a single center between 2015 and 2022 were reviewed. Variables including demographics and comorbidities were recorded. Rate, nature, and time in days of post-operative complications were evaluated. RESULTS: Sixty-nine cases were reviewed. Average patient age was 46.8 years old and 63.8% were male. The average follow-up period was 625 ± 724 days. 19 (27.5%) patients experienced one or more major complications including four (5.8%) who died. Eight (11.6%) patients required reintubation and 4 (5.8%) patients underwent revision tracheostomy. Most complications occurred within 8 days of surgery. Restenosis was noted an average of 42.6 days after surgery, with no new restenosis occurring after 3 months. CONCLUSIONS: In this single-center study, most post-operative complications after TR or CTR, including hematoma and anastomotic dehiscence, occurred within 8 days post-operatively. Restenosis was noted approximately 1-3 months after surgery. This may inform clinical decision-making regarding patient monitoring and surveillance after open airway surgery. LEVEL OF EVIDENCE: 4 Laryngoscope, 2024.

Decision-Making in the Treatment of Idiopathic Subglottic Stenosis: A Survey of Laryngologists.

OBJECTIVE: Idiopathic subglottic stenosis (iSGS) is a rare condition involving the subglottic larynx and upper trachea, commonly affecting Caucasian females between 30 and 50 years of age. Despite its homogeneous presentation, clinical management for iSGS is yet to be standardized, leading to variability in outcomes between predominant interventions. In recognition of the heterogenicity in iSGS treatment and the need to improve patient outcomes, this study aimed to survey laryngologists to understand the factors influencing clinical decision-making and the incorporation of new treatment modalities for iSGS. METHODS: An online survey was sent to 145 academic laryngologists. The survey assessed respondents' professional backgrounds, experience treating iSGS, treatment algorithms, and how various patient factors affect management. RESULTS: Of the 87 (60%) laryngologists who responded to the survey, the most common clinical assessments were tracheoscopy/bronchoscopy (96.8%) and pulmonary function tests (43.6%). Endoscopic dilation (ED) was the most common primary treatment offered (97.5%): 28.7% of surveyed laryngologists offer SISI as a primary treatment, and 74.7% perform SISI as a planned postoperative treatment. The most common SISI protocol was repeated injections every 4-6 weeks for a series of 1-3 total injections. Notably, 9.2% perform the Maddern procedure. Routine algorithms of care involving surgery were most often based on prior experience and prior patient outcomes (75.9%) and conversations with colleagues (64.4%). Only 31% report using the same protocol learned during their fellowship training. CONCLUSION: This survey highlights significant variation in the management of patients with iSGS. Understanding the factors that influence decision-making may lead to potential standardization in heterogeneous treatment approaches and may improve clinical outcomes. LEVEL OF EVIDENCE: 5 Laryngoscope, 134:865-872, 2024.

Factors Associated With Dysphagia in Patients Undergoing Tracheal Resection.

Importance: Patients undergoing tracheal resection commonly experience dysphagia postoperatively, and the patient factors that predict severity and duration of symptoms are currently unclear. Objective: To determine the association of patient and surgical factors on postoperative dysphagia in adult patients undergoing tracheal resection. Design, Setting, and Participants: This was a retrospective cohort study of patients undergoing tracheal resection at 2 tertiary academic centers from February 2014 to May 2021. The centers included LAC+USC (Los Angeles County + University of Southern California) Medical Center and Keck Hospital of USC, both tertiary care academic institutions. Patients involved in the study underwent a tracheal or cricotracheal resection. Exposures: Tracheal or cricotracheal resection. Main Outcomes and Measures: The main outcome was dysphagia symptoms as measured by the functional oral intake scale (FOIS) on postoperative days (PODs) 3, 5, and 7, on the day of discharge, and at the 1-month follow-up visit. Demographics, medical comorbidities, and surgical factors were evaluated for association with FOIS scores at each time period using Kendall rank correlation and Cliff delta. Results: The study cohort consisted of 54 patients, with a mean (SD) age of 47 (15.7) years old, of whom 34 (63%) were male. Length of resection segment ranged from 2 to 6 cm, with a mean (SD) length of 3.8 (1.2) cm. The median (range) FOIS score was 4 (1-7) on PODs 3, 5, 7. On the day of discharge and at 1-month postoperative follow-up, the median (range) FOIS score was 5 (1-7) and 7 (1-7), respectively. Increasing patient age was moderately associated with decreasing FOIS scores at all measured time points (τ = -0.33; 95% CI, -0.51 to -0.15 on POD 3; τ = -0.38; 95% CI, -0.55 to -0.21 on POD 5; τ = -0.33; 95% CI, -0.58 to -0.08 on POD 7; τ = -0.22; 95% CI, -0.42 to -0.01 on day of discharge; and τ = -0.31; 95% CI, -0.53 to -0.09 at 1-month follow-up visit). History of neurological disease, including traumatic brain injury and intraoperative hyoid release, was not associated with FOIS score at any of the measured time points (δ = 0.03; 95% CI, -0.31 to 0.36 on POD 3; δ = 0.11; 95% CI, -0.28 to 0.47 on POD 5, δ = 0.3; 95% CI, -0.25 to 0.70 on POD 7; δ = 0.15; 95% CI, -0.24 to 0.51 on the day of discharge, and δ = 0.27; 95% CI, -0.05 to 0.53 at follow-up). Resection length was also not correlated with FOIS score with τ ranging from -0.04 to -0.23. Conclusions and Relevance: In this retrospective cohort study, most patients undergoing tracheal or cricotracheal resection experienced full resolution of dysphagia symptoms within the initial follow-up period. During preoperative patient selection and counseling, physicians should consider that older adult patients will experience greater severity of dysphagia throughout their postoperative course and delayed resolution of symptoms.

Repair of Anterior Tracheal Defect by Trans-Tracheostomy Placement of Acellular Dermal Matrix.

Severe infections of the neck can lead to life-threatening consequences when not treated promptly and correctly. This case report is the first to illustrate the successful use of an acellular dermal matrix to repair a tracheal defect in the setting of a severe neck infection. Laryngoscope, 133:1961-1963, 2023.

Creation of an Open Bedside Tracheostomy Program at a Community Hospital With a Single Surgeon.

Objective: To assess the adverse event rate and operating cost of open bedside tracheostomy (OBT) at a community hospital. To present a model for creating an OBT program at a community hospital with a single surgeon. Study Design: Retrospective case series pilot study. Setting: Academic-affiliated community hospital. Methods: Retrospective chart review of surgical OBT and operating room tracheostomy (ORT) at a community hospital from 2016 to 2021. Primary outcomes included operation duration; perioperative, postoperative, and long-term complications; and crude time-based estimation of operating cost to the hospital using annual operating cost. Clinical outcomes of OBT were assessed with ORT as a comparison using t tests and Fisher's exact tests. Results: Fifty-five OBT and 14 ORT were identified. Intensive care unit (ICU) staff training in preparing for and assisting with OBT was successfully implemented by an Otolaryngologist and ICU nursing management. Operation duration was 20.3 minutes for OBT and 25.2 minutes for ORT (p = .14). Two percent, 18%, and 10% of OBT had perioperative, postoperative, and long-term complications, respectively; this was comparable to rates for ORT (p = .10). The hospital saved a crude estimate of $1902 in operating costs per tracheostomy when performed in the ICU. Conclusion: An OBT protocol can be successfully implemented at a single-surgeon community hospital. We present a model for creating an OBT program at a community hospital with limited staff and resources.

Variations in Practices and Preferences of Vocal Fold Injection Materials: A National Survey.

BACKGROUND: Vocal fold injection augmentation (VFI) is a common procedure for the treatment of glottic insufficiency. Material options for VFI and decisions regarding material selection are not standardized and often based on clinician preference. OBJECTIVE: This study aims to understand the variations in provider preference and utilization of injectable materials for VFI. METHODS: A 40-question survey was sent to 158 academic laryngologists. Questions pertained to the type of injectable materials used including brand preferences and rationale for preferences. RESULTS: Ninety-seven of the 158 laryngologists contacted participated in the survey (61.4%). The most frequently used injectable materials were Hyaluronic Acid (HA)-based products. Carboxymethylcellulose (CMC)-based products were preferred for trial augmentation (57.2%), HA-based products were preferred for acute/subacute vocal fold paralysis, presbyphonia, and sulcus/scar (54.2%, 61.5%, 44.7%, 41.7% respectively), and Calcium Hydroxyapatite (CaHA)-based products were preferred for long-term paralysis (28.1%). CMC-based products were discontinued by 21.8% of participants, largely due to quick material resorption. 17.8% of participants discontinued HA-based products largely due to adverse events and 26.0% abandoned CaHA-based products mostly due to inflammatory properties causing vocal fold stiffness and material unpredictability. Over 30% of respondents reported wanting to reinitiate micronized alloderm Cymetra® as an available injectable. CONCLUSION: Our survey demonstrated that there are significant variations in practice and preferences in regard to injectable material selection for VFI. As there is limited data on the direct material comparison, understanding the rationale behind these variations is crucial to guide new providers in material selection and provide information to patients undergoing these procedures. LEVEL OF EVIDENCE: 5 Laryngoscope, 133:1176-1183, 2023.

Serial In-Office Steroid Injections for Airway Stenosis: Long-Term Benefit and Cost Analysis.

OBJECTIVES: To evaluate the long-term benefit of serial in-office steroid injections (SISI) in the treatment of subglottic and proximal tracheal stenosis (SG/PTS). Evaluate cost of SISI compared to endoscopic dilation (ED). STUDY DESIGN: Retrospective study and cost analysis. METHODS: All patients with SGS/PTS with at least two consecutive in-office steroid injections between 2013 and 2021 were evaluated. Patients with less than 2 years of follow-up data after the initial SISI series were excluded. Demographics, etiology of stenosis, total injections performed, time between steroid series, surgery-free interval (SFI) and adverse events were collected. For patients with known surgical history before SISI, pre-SISI SFI was compared. Institutional billing records and the national CMS average reimbursement were evaluated. Total charges for three treatment strategies (ED alone, ED with post-operative SISI and primary intervention with SISI) were also compared. RESULTS: Forty-nine patients were included; 29 (59%) idiopathic, 11 (22%) traumatic and 9 (18%) rheumatologic. Mean (SD) follow-up time after the first SISI was 3.41 years (1.5), range (2.08-7.25 years). 79% (39/49) did not require additional surgery during the entire follow-up period. The SFI improved from a mean 13.5 months (SD 12.6; range 2-42 months) pre-SISI to a mean (SD) of 42 months (SD 20.2; range 10-87 months) (p < 0.0001) after SISI. Annual average charges for ED alone in our cohort was $15,383.28, compared to $7,070.04 for SISI. CONCLUSIONS: SISI are an effective treatment for patients with SG/PTS. In-office steroid injections could offer cost savings for the patient. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:2673-2679, 2023.

Platelet-Rich Plasma for Vocal Fold Scar: A Preliminary Report of Concept.

INTRODUCTION: Vocal fold atrophy and scar can lead to loss of normal superficial lamina propria, negatively affecting the vibratory function of the vocal fold. These changes can lead to dysphonia, vocal fatigue, decreased volume, and altered pitch. Treatment options for these conditions are limited. Platelet-rich plasma (PRP) consists of platelets, growth factors, and cytokines derived from the patient's own blood and is believed to activate tissue regeneration. The purpose of this study was to review the technical aspects of collecting PRP and injecting it into the vocal fold injection - based on our initial experience with this procedure. CASE: A patient with vocal fold scar was identified and enrolled in an ongoing prospective clinical trial study of a series of 4 monthly subepithelial vocal fold PRP injections, which was temporarily halted due to the COVID-19 pandemic. Patient underwent a single injection of autologous PRP into the left vocal fold. There were no adverse events during the study period. Subjective improvement in voice was noted at 1 month after injection with subsequent return to baseline over the next 4 months. Videostroboscopy performed on postinjection day 1 and day 7 and demonstrated no concerning exam changes. Compared to the preinjection baseline, the patient-reported voice-handicap index-10 (VHI-10) and voice catastrophization index were similar at 4 months following injection (20 to 20 and 4 to 3, respectively). Independent perceptual analysis of voice showed improvement at 4 months postinjection, compared to baseline consensus auditory-perceptual evaluation of voice 60 to 44. CONCLUSIONS: This preliminary report was part of a prospective trial investigating the use of PRP to treat vocal fold atrophy and scar. This work highlights the technical considerations for injecting PRP into the vocal fold. Planned prospective enrollment in this study will help to validate the safety and efficacy of PRP injections.

Open Bedside Tracheostomy: Safe and Cost Saving but Underutilized Nationally.

OBJECTIVE: To evaluate open bedside tracheostomy (OBT) and compare it with open operating room (OR) tracheostomy and bedside percutaneous dilatational tracheostomy (PDT) in complications and cost. To determine the tracheostomy practice patterns of academic otolaryngology programs. STUDY DESIGN: Retrospective cohort study and cross-sectional study. SETTING: Public hospital and tertiary care hospital. METHODS: Otolaryngology program directors were surveyed to determine their institutions' tracheostomy practice patterns and the factors preventing the implementation of open bedside tracheostomies. A retrospective chart review was done of tracheostomies performed at our institutions from 2009 to 2019 for prolonged mechanical ventilation. Complications, length of intubation, comorbidities, body mass index, demographics, mortality rates, and decannulation rates were recorded. A cost analysis between OBT and PDT was conducted. RESULTS: Data from 802 patients were analyzed for 449 OBTs, 206 PDTs, and 147 open OR tracheostomies. Complication rates were low. PDTs were more likely to have perioperative tracheal bleeding (P = .028) and mucus plugging (P = .006). OBTs were performed on sicker patients with a higher Charlson Comorbidity Index than PDT and OR tracheostomies. The cost of OBT was less than that of PDT. The survey response rate of tracheostomy practice patterns was 46%. The otolaryngologists at the responding programs all conducted OR tracheostomies, while 52.7% did OBTs and 30.9% PDTs. CONCLUSION: OBT can be done safely in patients with multiple comorbidities and has a cost that can be less than PDT. Despite these benefits, only 50% of academic institutions routinely performed OBT.

A Novel Grading System for Supraglottic Stenosis Based on Morphology and Functional Status.

OBJECTIVE: Currently, no classification system exists to grade the severity of supraglottic stenosis. The aim of this investigation was to (1) develop a novel grading system for supraglottic stenosis that can both enhance communication between providers and relay information about patient functional status and (2) determine the reliability of the grading system. METHODS: A retrospective analysis of patients with supraglottic stenosis at three institutions from 2010-2021 was conducted. After demographic data were collected, two focus group meetings of five laryngologists were held to develop a grading system based on functional status and morphology of stenosis seen on laryngoscopy. Three laryngologists then used the grading system to rate 20 case examples of supraglottic stenosis. Quadratic-weighted kappa coefficients were calculated to assess inter-rater and intra-rater reliabilities of the novel grading system. RESULTS: Twenty-eight patients were included. Epiglottic and arytenoid fixation were morphological features associated with worse functional outcomes such as requiring a G-tube or a tracheostomy, respectively. Inter-rater reliability was substantial to almost perfect (Kw = 0.79-0.81) and intra-rater reliability was almost perfect for all raters (0.88-1.0) when using the novel grading system. CONCLUSION: A grading system for supraglottic stenosis has been proposed with strong inter-rater and intra-rater reliabilities. The proposed system has the advantage of being descriptive of both patient functionality and morphology of the stenosis. LEVEL OF EVIDENCE: 3-According to the Oxford Center for Evidence-Based Medicine 2011 level of evidence guidelines, this non-randomized retrospective cohort study is classified as level 3 evidence Laryngoscope, 133:1442-1447, 2023.

The Effect of Subglottic Steroid injection on Blood Glucose in a Cohort of Patients With Subglottic Stenosis.

OBJECTIVE: The objective of this work was to assess the effect of a single intralesional subglottic steroid injection on fasting blood glucose over 7 days in a cohort of patients with subglottic stenosis. METHODS: A prospective cohort study of patients undergoing intralesional steroid injections at a tertiary academic center. Patients had baseline bloodwork performed, including fasting blood glucose (FBG), and hemoglobin A1C levels. Demographic data and risk factors were collected. Fasting capillary glucose (FCG) was measured using a capillary glucometer and performed by patients daily from days 0 to 7 after a single injection of Triamcinolone into the subglottic airway. Data were analyzed using descriptive and comparative statistics. RESULTS: Eleven patients were enrolled, and 10 completed data collection over 7 days. All were female, with a mean age of 52.6 years (SD 17.5). Two patients were diabetic (non-insulin dependent). There was a statistically significant increase in FCG on day 1 post-injection (mean = 122.4 mg/dl compared to 100.7 mg/dl) that normalized for all patients within 24-72 h. The mean increase in FCG was 21.5% (SD 22.5%) of the initial value for the cohort. The diabetic group had statistically significant higher glucose values on day 1 compared to the non-diabetic group (146.5 mg/dl compared to 117.0 mg/dl). CONCLUSION: A single subglottic steroid injection appears to cause a transient increase in FCG 1 day post injection, which resolves after 24-72 h and can be more pronounced in diabetic patients. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:1590-1594, 2023.

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.

Safety of Platelet-Rich Plasma Subepithelial Infusion for Vocal Fold Scar, Sulcus, and Atrophy.

OBJECTIVE: To demonstrate the safety profile of platelet-rich plasma (PRP) as an injectable therapeutic for the treatment of vocal fold scarring and atrophy. METHODS: Preliminary report on a prospective clinical trial of patients with vocal fold scar or atrophy undergoing unilateral vocal fold subepithelial infusion with autologous PRP. Enrolled patients underwent four subepithelial injections spaced 1 month apart. Adverse events were assessed peri and post-injection at each session. Patient-reported outcomes were collected at every visit using the Voice Handicap Index-10 (VHI-10) and Vocal Fatigue Index (VFI) questionnaires. RESULTS: Twelve patients underwent unilateral vocal fold injection with autologous PRP prepared according to Eclipse PRP® system protocol. Forty-three injections were performed using a peroral or percutaneous approach. An average of 1.57 ± 0.4 cc (range 0.6-2.0 cc) injectate was used. All patients tolerated the procedure without difficulty or peri-procedural complications. The average duration of follow-up was 3.6 ± 1.8 months. No significant inflammatory reactions or adverse events were seen to date. There was statistically significant improvement in patient-reported outcomes at the 3 month follow up (n = 9) follow-up (mean ΔVHI-10 = 10.8, p < 0.001, mean ΔVFI = 18.9, p = 0.01, t test, paired two sample for means, two-tail). All nine patients who completed the series of four injections subjectively (yes/no) reported they were satisfied with the results. CONCLUSION: This prospective study cohort demonstrated a favorable safety profile, with no adverse events or peri-procedural complications. Subjective improvements in vocal quality and reduction in vocal fatigue need to be clinically correlated with further study. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:647-653, 2023.

Flexible Versus Rigid Laryngoscopy: A Prospective, Blinded Comparison of Image Quality.

OBJECTIVE: To compare flexible distal-chip laryngoscopy (FDL) and rigid telescopic laryngoscopy (RTL) in image quality and diagnostic ability. STUDY DESIGN: Prospective cohort study; blinded comparison. METHODS: Eighteen normal adult subjects were recruited to undergo both FDL and RTL and normalized videos were recorded. Three blinded laryngologists compared the videos for color fidelity, illumination, resolution, and vascularity, and indicated superiority with FDL, RTL, or no difference. Raters also reported if an abnormality was seen and in which video it was better visualized. Videos for two subjects were repeated to assess intra-rater reliability, making 20 video comparisons across 3 raters for a total of 60 ratings. Differences in responses were analyzed via Mann-Whitney U and Pearson Χ2. Inter-rater reliability was assessed via Fleiss' kappa, and intra-rater reliability was assessed via percent agreement. RESULTS: RTL was rated superior in all categories of image quality (47 vs 5 vs 8, P < 0.01; 47 vs 7 vs 6, P < 0.01; 51 vs 5 vs 4, P<0.01; 44 vs 9 vs 7, P < 0.01, respectively). An abnormality was seen 33 times with both modalities and 6 times with RTL only. When seen with both modalities, visualization was superior in RTL compared with FDL (29 vs 4, P <0.01). CONCLUSIONS: There was significant superiority of RTL in all categories of image quality, with slight inter-rater agreement for color fidelity, resolution, and vascularity. RTL was also significantly better for visualization of abnormalities. These findings suggest superior image quality in RTL compared with FDL, but further research is required to determine if this difference is clinically significant.

Validation of an AI-assisted Treatment Outcome Measure for Gender-Affirming Voice Care: Comparing AI Accuracy to Listener's Perception of Voice Femininity.

OBJECTIVES: There is currently a lack of objective treatment outcome measures for transgender individuals undergoing gender-affirming voice care. Recently, Bensoussan et al developed an AI model that is able to generate a voice femininity rating based on a short voice sample provided through a smartphone application. The purpose of this study was to examine the feasibility of using this model as a treatment outcome measure by comparing its performance to human listeners. Additionally, we examined the effect of two different training datasets on the model's accuracy and performance when presented with external data. METHODS: 100 voice recordings from 50 cisgender males and 50 cisgender females were retrospectively collected from patients presenting at a university voice clinic for reasons other than dysphonia. The recordings were evaluated by expert and naïve human listeners, who rated each voice based on how sure they were the voice belonged to a female speaker (% voice femininity [R]). Human ratings were compared to ratings generated by (1) the AI model trained on a high-quality low-quantity dataset (voices from the Perceptual Voice Quality Database) (PVQD model), and (2) the AI model trained on a low-quality high-quantity dataset (voices from the Mozilla Common Voice database) (Mozilla model). Ambiguity scores were calculated as the absolute value of the difference between the rating and certainty (0 or 100%). RESULTS: Both expert and naïve listeners achieved 100% accuracy in identifying voice gender based on a binary classification (female >50% voice femininity [R]). In comparison, the Mozilla-trained model achieved 92% accuracy and the previously published PVQD model achieved 84% accuracy in determining voice gender (female >50% AI voice femininity). While both AI models correlated with human ratings, the Mozilla-trained model showed a stronger correlation as well as lower overall rating ambiguity than the PVQD-trained model. The Mozilla model also appeared to handle pitch information in a similar way to human raters. CONCLUSIONS: The AI model predicted voice gender with high accuracy when compared to human listeners and has potential as a useful outcome measure for transgender individuals receiving gender-affirming voice training. The Mozilla-trained model performed better than the PVQD-trained model, indicating that for binary classification tasks, the quantity of data may influence accuracy more than the quality of the data used for training the voice AI models.