Safety of a Novel Upper Esophageal Sphincter Balloon Dilator.

OBJECTIVE: The shape of esophageal dilators has not changed in over 350 years. Clinical and animal research suggests that the upper esophageal sphincter (UES) is not round but approximates a kidney shape and that cylindrical dilators may be suboptimal. The Infinity UES Dilation System has been developed specifically for the anatomic configuration of the UES. This study evaluates the safety of the UES-specific Infinity Dilation System. METHODS: All patients undergoing dilation of the UES between January 1, 2022 and September 1, 2023 were included. Demographics, procedure indication, dilator type, minor adverse events, and major complications were abstracted. Minor adverse events, complications, and maximum dilation dimension (mm) were compared between groups. RESULTS: A total of 477 patients were included. Eight hundred and seventy-three total UES dilations were performed. The primary indications for UES dilation were cricopharyngeus muscle dysfunction (43%) and stenosis from radiation toxicity (40%). Twenty-three percent (202/873) of dilations were performed with an Infinity balloon, 31% (270/873) were performed using two conventional balloons placed side by side, and 46% (401/873) were performed with one singleton conventional balloon. The average maximum dilation dimension was 33 (±4.7) mm for Infinity balloons, 32 (±3.8) mm for two side-by-side balloons, and 18 (±3.4) mm for singleton balloons. There were three major complications with conventional balloons and none with Infinity balloons. There were no significant differences in minor adverse events between groups. CONCLUSIONS: A UES-specific esophageal dilator provides a greater maximum dilation dimension and appears to be at least as safe as dilation with a single cylindrical balloon designed to dilate the esophagus. LEVEL OF EVIDENCE: Level 3 Laryngoscope, 2024.

The Global Experience of Laryngeal Transplantation: Series of Eleven Patients in Three Continents.

BACKGROUND: The loss of laryngeal function affects breathing, swallowing, and voice, thus severely compromises quality of life. Laryngeal transplantation has long been suggested as a solution for selected highly affected patients with complete laryngeal function loss. OBJECTIVE: To obtain insights regarding the advantages, weaknesses, and limitations of this procedure and facilitate future advances, we collected uniform data from all known laryngeal transplants reported internationally. METHODOLOGY: A case series. Patients were enrolled retrospectively by each institutional hospital or clinic. Eleven patients with complete loss of laryngeal function undergoing total laryngeal transplantation between 1998 and 2018 were recruited. RESULTS: After a minimum of 24 months follow-up, three patients had died (27%), and there were two graft explants in survivors, one total and one partial, due to chronic rejection. In the remaining cases, voice was functional in 62.5% and 50% achieved decannulation. Swallowing was initially restricted, but only one patient was gastrostomy-dependent by 6 months and all had normal or near-normal swallowing by the end of year two after transplantation. Median follow-up was 73 months. Functional (voice, swallowing, airway) recovery peaked between 12 and 24 months. CONCLUSIONS: Laryngeal transplantation is a complex procedure with significant morbidity. Significant improvements in quality of life are possible for highly selected individuals with end-stage laryngeal disorders, including laryngeal neoplasia, but further technical and pharmacological developments are required if the technique is to be more widely applicable. An international registry should be created to provide better quality pooled data for analysis of outcomes of any future laryngeal transplants. LEVEL OF EVIDENCE: IV Laryngoscope, 2024.

The Dubai Definition and Diagnostic Criteria of Laryngopharyngeal Reflux: The IFOS Consensus.

OBJECTIVE: The objective of this work was to gather an international consensus group to propose a global definition and diagnostic approach of laryngopharyngeal reflux (LPR) to guide primary care and specialist physicians in the management of LPR. METHODS: Forty-eight international experts (otolaryngologists, gastroenterologists, surgeons, and physiologists) were included in a modified Delphi process to revise 48 statements about definition, clinical presentation, and diagnostic approaches to LPR. Three voting rounds determined a consensus statement to be acceptable when 80% of experts agreed with a rating of at least 8/10. Votes were anonymous and the analyses of voting rounds were performed by an independent statistician. RESULTS: After the third round, 79.2% of statements (N = 38/48) were approved. LPR was defined as a disease of the upper aerodigestive tract resulting from the direct and/or indirect effects of gastroduodenal content reflux, inducing morphological and/or neurological changes in the upper aerodigestive tract. LPR is associated with recognized non-specific laryngeal and extra-laryngeal symptoms and signs that can be evaluated with validated patient-reported outcome questionnaires and clinical instruments. The hypopharyngeal-esophageal multichannel intraluminal impedance-pH testing can suggest the diagnosis of LPR when there is >1 acid, weakly acid or nonacid hypopharyngeal reflux event in 24 h. CONCLUSION: A global consensus definition for LPR is presented to improve detection and diagnosis of the disease for otolaryngologists, pulmonologists, gastroenterologists, surgeons, and primary care practitioners. The approved statements are offered to improve collaborative research by adopting common and validated diagnostic approaches to LPR. LEVEL OF EVIDENCE: 5 Laryngoscope, 134:1614-1624, 2024.

Clinician accuracy in identifying essential laryngeal landmarks on swallowing fluoroscopy.

Objective: Identification of anatomical landmarks is essential for interpretation of video fluoroscopic swallow studies (VFSS). This investigation sought to confirm the location of essential laryngeal landmarks and determine clinician accuracy in structure identification on VFSS. Methods: A single human cadaver was used to generate unmarked standard lateral and anterior-posterior (AP) fluoroscopic images. Essential laryngeal structures (e.g., true vocal fold, arytenoid) were directly identified using a guidewire placed through an endoscope while obtaining corresponding marked fluoroscopic images. Licensed clinicians (speech-language pathologists [SLP], laryngologists) and trainees (otolaryngology residents, SLP clinical fellows [CF]) identified 18 structures (9 lateral, 9 AP) on unmarked images. Answers were compared to corresponding marked images. The percentage of accurate identification was calculated for each clinician and then compared between groups using t-tests. Results: Twenty-four individuals (10 SLPs, 1 CF, 9 residents, 4 laryngologists) from six institutions completed structure identification. Mean overall accuracy was 41.7 ± 13.0% (range 18.8-68.8%). There were no significant differences in mean overall accuracy between trainees (41.9 ± 12.9%) and clinicians (42.0 ± 13.1%), p = .97, or between SLPs (45.5 ± 12.8%) and physicians (38.9 ± 12.3%), p = .22. On average, participants were significantly more accurate identifying structures on lateral view (53.1 ± 16.1%) than AP (27.3 ± 22.8%), p < .001. Less than half of participants accurately identified the laryngeal ventricle, cricoid, epiglottic petiole, and the anterior commissure on lateral view. Conclusions: The ability of certified clinicians and trainees to correctly identify essential anatomic landmarks on swallowing fluoroscopy may be poor. Future work is needed to identify how we can train clinicians on more accurate identification of essential anatomic structures on swallowing fluoroscopy.Level of Evidence: NA.

Use of a Novel Hypercrosslinked Carbohydrate Scaffold for Vocal Fold Medialization in an Ovine Model.

Objectives: Vocal fold medialization is commonly performed for glottic insufficiency and vocal fold immobility. Currently available materials are temporary injectables or synthetic implants. Acellular scaffolds may allow vocal fold augmentation with autologous tissue via host cell migration. The purpose of this investigation was to evaluate the use of a novel carbohydrate scaffold as a medialization implant. Study Design: Animal model. Setting: Academic medical center. Methods: Unilateral type I medialization thyroplasty was performed in 3 Dorper cross ewes using a hypercrosslinked carbohydrate polymer (HCCP) scaffold. Animals were monitored for 4 weeks for general well-being, dyspnea, and weight loss. The animals were euthanized at 4 weeks and the larynges harvested. Histologic evaluation was performed to assess for adverse tissue reaction, migration, degradation, and biocompatibility. Results: No adverse events were reported. No animals lost weight or displayed evidence of dyspnea. Histology demonstrated ingrowth of host cells and neovascularization with minimal peri-implant inflammatory reaction. Cellular ingrowth into the scaffold was predominately made up of fibroblasts and early inflammatory cells. Scaffold shape was grossly maintained as it underwent degradation and replacement with host tissue. Migration of the implant material was not observed. Conclusion: Vocal fold medialization in an ovine model with an HCCP scaffold resulted in the ingrowth of host cells with minimal peri-implant inflammation. Scaffold shape was maintained without evidence of migration as it underwent replacement with host tissue. Further research is required to assess long-term efficacy in comparison to currently available implants.

Partners of persons with severe swallowing dysfunction have significantly reduced mental health.

INTRODUCTION: Dysphagia can result in malnutrition, dehydration, social isolation, depression, pneumonia, pulmonary abscess, and death. The effect of dysphagia on the health and quality of life (QOL) of the life partners of persons with dysphagia is uncertain. We hypothesize that the partners of individuals with significant dysphagia will experience a significant reduction in quality of life. PURPOSE: To evaluate the QOL of the significant others of persons with swallowing dysfunction. METHODOLOGY: Persons with significant swallowing dysfunction (defined as EAT10® > 10) and their significant others were prospectively administered the 10-item Eating Assessment Tool (EAT10®) patient-reported outcome measure and the 12-item SF quality of life instrument (SF12). Summary data from the 8 mean health domains were compared between patients and their significant others. Mean scores for each domain are calibrated at 50, and a score below 47 implies significantly diminished QOL for a particular domain. RESULTS: Twenty-three couples were evaluated. The mean ± SD EAT10 score for persons with significant dysphagia was 21 ± 7; mean EAT10 for their significant others or for couples in the control group was 0.3 ± 0.8. The mean physical health composite score (PCS) was significantly lower for patients with dysphagia compared to their significant others (39.1 ± 10 and 46.2 ± 11, respectively) (p < 0.05). Both patients and their significant others had comparable mean mental health composite scores (MCS) of 46.6 ± 10 and 46.4 ± 10, respectively (p > 0.05). CONCLUSION: Although significant others of persons with swallowing dysfunction have higher physical well-being than their partners, they exhibit the same reduction in mental well-being, which is significantly lower than the general population. The data suggest that clinicians should address the mental well-being of the partners of persons with severe swallowing dysfunction.

Objective Fluoroscopic Outcomes After Endoscopic Staple Versus Laser Zenker's Diverticulotomy.

OBJECTIVE: Endoscopic Zenker's diverticulotomy (EZD) is typically performed via stapling (endoscopic staple diverticulotomy; ESD) or CO2 laser (endoscopic laser diverticulotomy; ELD). Conflicting reports exist on which approach provides optimal outcomes. This investigation compared objective fluoroscopic data between ESD and ELD. METHODS: A retrospective review of all patients undergoing primary EZD at a tertiary center between January 1, 2014 and January 10, 2022 was performed. Patients undergoing ESD and ELD were matched by preoperative diverticulum size. Primary outcome measures were postoperative diverticulum size and change in diverticulum size from pre- to postoperative swallowing fluoroscopy. Secondary outcome measures were the Eating Assessment Tool (EAT-10) score, penetration aspiration scale (PAS), pharyngeal constriction ratio (PCR), and pharyngoesophageal segment opening (PESo). RESULTS: Thirteen matched pairs with complete fluoroscopic data were identified. The mean (±SD) age of the cohort was 74.0 (±8.5) years. There were no age or gender differences between groups (p > 0.05). The mean pre-operative ZD size was 1.98 (±0.69) cm for ESD and 1.97 (±0.72) cm for ELD; the mean postoperative size was 0.84 (±0.62) cm for ESD and 0.34 (±0.27) cm for ELD (p < 0.05). Mean diverticulum size improved by 1.14 (±0.59) cm after ESD and 1.62 (±0.59) cm after ELD (p < 0.05). There were no significant differences in postoperative EAT-10, PAS, PCR, or PESo between groups. CONCLUSION: The data suggest that endoscopic laser Zenker's diverticulotomy results in a greater improvement in diverticulum size than endoscopic staple diverticulotomy. The data did not suggest a difference in postoperative dysphagia symptom scores or other objective fluoroscopic parameters between staple and laser diverticulotomy. LEVEL OF EVIDENCES: Level 3 Laryngoscope, 133:3057-3060, 2023.

Interim Results of a Phase 1/2 Open-Label Study of INO-3107 for HPV-6 and/or HPV-11-Associated Recurrent Respiratory Papillomatosis.

OBJECTIVE: To evaluate the safety, immunogenicity, and efficacy of INO-3107, a DNA immunotherapy designed to elicit targeted T-cell responses against human papillomavirus (HPV) types 6 and 11, in adult patients with recurrent respiratory papillomatosis (RRP; NCT04398433). METHODS: Eligible patients required ≥2 surgical interventions for RRP in the year preceding dosing. INO-3107 was administered by intramuscular (IM) injection followed by electroporation (EP) on weeks 0, 3, 6, and 9. Patients underwent surgical debulking within 14 days prior to first dose, with office laryngoscopy and staging at screening and weeks 6, 11, 26, and 52. Primary endpoint was safety and tolerability, as assessed by treatment-emergent adverse events (TEAEs). Secondary endpoints included frequency of surgical interventions post-INO-3107 and cellular immune responses. RESULTS: An initial cohort of 21 patients was enrolled between October 2020 and August 2021. Fifteen (71.4%) patients had ≥1 TEAE; 11 (52.4%) were Grade 1, and 3 (14.3%) were Grade 3 (none treatment related). The most frequently reported TEAE was injection site or procedural pain (n = 8; 38.1%). Sixteen (76.2%) patients had fewer surgical interventions in the year following INO-3107 administration, with a median decrease of 3 interventions versus the preceding year. The RRP severity score, modified by Pransky, showed improvement from baseline to week 52. INO-3107 induced durable cellular responses against HPV-6 and HPV-11, with an increase in activated CD4 and CD8 T cells and CD8 cells with lytic potential. CONCLUSION: The data suggest that INO-3107 administered by IM/EP is tolerable and immunogenic and provides clinical benefit to adults with RRP. LEVEL OF EVIDENCE: 3 Laryngoscope, 133:3087-3093, 2023.

Upper Instrumented Vertebrae, Number of Levels Fused, and Plate Morphology Do Not Affect Severity of Chronic Dysphagia After Anterior Cervical Spine Surgery.

BACKGROUND: Disordered swallowing, or dysphagia, is the most common complication after anterior cervical spine (ACS) surgery. Many operative factors are associated with development of dysphagia. The aim of this study was to explore how number of levels instrumented, specific levels fused, and plate morphology affect chronic dysphagia after ACS surgery. METHODS: Consecutive patients referred to a tertiary center for otolaryngology evaluation for chronic dysphagia after ACS surgery between 2012 and 2017 were enrolled. Basic demographic data were obtained. Plain radiographs were reviewed for number of levels fused, upper instrumented vertebrae, and plate morphology. Plate morphology was categorized as a closed, small window, large window, or no profile plate. The 10-item Eating Assessment Tool (EAT-10) was used to assess dysphagia severity. RESULTS: Of 171 patients referred for dysphagia, 126 met inclusion criteria; 54% were female, with a mean age of 63 years (range, 32-88 years). Mean EAT-10 score was 18.5 ± 10.1. Mean time from spine surgery to videofluoroscopic swallow study for dysphagia was 58.3 months. Mean number of levels fused was 2.2 ± 0.9. There were no significant differences in EAT-10 scores in single-level versus multilevel fusion (19.0 vs. 18.4, P = 0.76) as well as with regard to upper instrumented vertebrae or plate morphology. CONCLUSIONS: In this series of patients with chronic dysphagia following ACS surgery, the severity of dysphagia as measured by the EAT-10 was not affected by upper instrumented vertebrae, number of levels fused, or plate morphology.

Best Practices in Treatment of Laryngopharyngeal Reflux Disease: A Multidisciplinary Modified Delphi Study.

BACKGROUND: Laryngopharyngeal reflux (LPR) is a common otolaryngologic diagnosis. Treatment of presumed LPR remains challenging, and limited frameworks exist to guide treatment. METHODS: Using RAND/University of California, Los Angeles (UCLA) Appropriateness Methods, a modified Delphi approach identified consensus statements to guide LPR treatment. Experts independently and blindly scored proposed statements on importance, scientific acceptability, usability, and feasibility in a four-round iterative process. Accepted measures reached scores with ≥ 80% agreement in the 7-9 range (on a 9-point Likert scale) across all four categories. RESULTS: Fifteen experts rated 36 proposed initial statements. In round one, 10 (27.8%) statements were rated as valid. In round two, 8 statements were modified based on panel suggestions, and experts subsequently rated 5 of these statements as valid. Round three's discussion refined statements not yet accepted, and in round four, additional voting identified 2 additional statements as valid. In total, 17 (47.2%) best practice statements reached consensus, touching on topics as varied as role of empiric treatment, medication use, lifestyle modifications, and indications for laryngoscopy. CONCLUSION: Using a well-tested methodology, best practice statements in the treatment of LPR were identified. The statements serve to guide physicians on LPR treatment considerations.

A Comparative Assessment of the Diagnosis of Swallowing Impairment and Gastroesophageal Reflux in Canines and Humans.

Swallowing impairment is a highly prevalent and clinically significant problem affecting people and dogs. There are myriad causes of swallowing impairment of which gastroesophageal reflux is the most common in both species. Similarities in anatomy and physiology between humans and canines results in analogous swallowing disorders including cricopharyngeus muscle achalasia, esophageal achalasia, hiatal herniation, and gastroesophageal reflux with secondary esophagitis and esophageal dysmotility. Accordingly, the diagnostic approach to human and canine patients with swallowing impairment is similar. Diagnostic procedures such as swallowing fluoroscopy, high-resolution manometry, pH/impedance monitoring, and endolumenal functional luminal imaging probe can be performed in both species; however, nasofacial conformation, increased esophageal length, and the difficulty of completing several of these procedures in awake dogs are inherent challenges that need to be considered. Human patients can convey their symptoms and respond to verbal cues, whereas veterinarians must rely on clinical histories narrated by pet owners followed by comprehensive physical examination and observation of the animal eating different food consistencies and drinking water. Dogs may also be unwilling to drink or eat in the hospital setting and may be resistant to physical restraint during diagnostic procedures. Despite the species differences and diagnostic challenges, dogs are a natural animal model for many oropharyngeal and esophageal disorders affecting people, which presents a tremendous opportunity for shared learnings. This manuscript reviews the comparative aspects of esophageal anatomy and physiology between humans and canines, summarizes the diagnostic assessment of swallowing impairment in both species, and discusses future considerations for collaborative medicine and translational research.

Autologous Muscle-Derived Cell Therapy for Swallowing Impairment in Patients Following Treatment for Head and Neck Cancer.

OBJECTIVES/HYPOTHESIS: To evaluate the safety and potential efficacy of autologous muscle-derived cells (AMDCs) for the treatment of swallowing impairment following treatment for oropharynx cancer. STUDY DESIGN: Prospective, phase I, open label, clinical trial. METHODS: Oropharynx cancer survivors disease free ≥2 years post chemoradiation were recruited. All patients had swallowing impairment but were not feeding tube dependent (Functional Oral Intake Scale [FOIS] ≥ 5). Muscle tissue (50-250 mg) was harvested from the vastus lateralis and 150 × 106 AMDCs were prepared (Cook MyoSite Inc., Pittsburgh, PA). The cells were injected into four sites throughout the intrinsic tongue musculature. Participants were followed for 24 months. The primary outcome measure was safety. Secondary endpoints included objective measures on swallowing fluoroscopy, oral and pharyngeal pressure, and changes in patient-reported outcomes. RESULTS: Ten individuals were enrolled. 100% (10/10) were male. The mean age of the cohort was 65 (±8.87) years. No serious adverse event occurred. Mean tongue pressure increased significantly from 26.3 (±11.1) to 31.8 (±9.5) kPa (P = .017). The mean penetration-aspiration scale did not significantly change from 5.6 (±2.1) to 6.8 (±1.8), and the mean FOIS did not significantly change from 5.4 (±0.5) to 4.6 (±0.7). The incidence of pneumonia was 30% (3/10) and only 10% (1/10) experienced deterioration in swallowing function throughout 2 years of follow-up. The mean eating assessment tool (EAT-10) did not significantly change from 24.1 (±5.57) to 21.3 (±6.3) (P = .12). CONCLUSION: Results of this phase I clinical trial demonstrate that injection of 150 × 106 AMDCs into the tongue is safe and may improve tongue strength, which is durable at 2 years. A blinded placebo-controlled trial is warranted. LEVEL OF EVIDENCE: 3 Laryngoscope, 132:523-527, 2022.

Effects of Pyridostigmine on Esophageal and Pharyngeal Motility in Dysphagic Patients Undergoing High-Resolution Manometry.

Weak or absent peristalsis of the esophageal musculature is a common finding in ambulatory patients suffering from dysphagia and frequently associated with gastroesophageal reflux. There is currently no pharmacologic intervention that reliably improves esophageal contractility in patients suffering from various esophageal motility disorders. Our objective was to evaluate the acute effects of pyridostigmine on high-resolution manometry parameters in patients suffering from dysphagia with evidence of esophageal dysmotility. Pyridostigmine is an acetylcholinesterase inhibitor which increases effective concentrations of acetylcholine at the neuromuscular junction of both striated and smooth muscle cells. We conducted a prospective crossover study of five patients with dysphagia and proven esophageal dysmotility. Three patients had baseline ineffective esophageal motility and two had achalasia. Patients underwent pharyngeal and esophageal manometry before and after pyridostigmine administration. The median distal contractile integral (DCI), a marker of esophageal contractile vigor, was significantly higher post pyridostigmine administration 3001 (1950.3-3703.2) mmHg × s × cm compared to pre-pyridostigmine DCI of 1229.9 (956.2-2100) mmHg × s × cm; P < 0.001. Pre-pyridostigmine 18/25 (72%) of the patient's swallows was peristaltic compared to 25/25 (100%) post-pyridostigmine; P < 0.005. No other pharyngeal or esophageal high-resolution manometry parameter differed significantly after pyridostigmine administration. The results of this pilot study demonstrate that pyridostigmine acutely improves esophageal contractile vigor in patients suffering from dysphagia with esophageal dysmotility. Further investigation with larger sample size, longer follow-up, side effect profile, and patient-reported outcome measures is still needed to determine the clinical usefulness of pyridostigmine in specific disorders of esophageal motility.

Effect of Pretreatment Dysphagia on Postchemoradiation Swallowing Function in Head and Neck Cancer.

OBJECTIVES: Chemoradiation therapy (CRT) for head and neck cancer can have profound effects on swallowing function. Identification of risk factors for development of swallowing dysfunction after CRT may improve allocation of preventive strategies. The purpose of this study is to determine the association between pre-CRT dysphagia and post-CRT swallowing dysfunction. STUDY DESIGN: Retrospective cohort study. SETTING: Academic medical center. METHODS: Patients with head and neck cancer were evaluated before and 3 months after CRT. Dysphagia was assessed with the Eating Assessment Tool (EAT-10). Swallowing dysfunction was evaluated by a videofluoroscopic swallow study and the Penetration-Aspiration Scale and swallowing safety was evaluated by the Functional Oral Intake Scale. The association between pre-CRT EAT-10 scores and post-CRT swallowing dysfunction was evaluated. RESULTS: The mean ± SD post-CRT Functional Oral Intake Scale score was 6.5 ± 1.2 for individuals with a pre-CRT EAT-10 score <3 and 5.3 ± 1.9 for those with a pre-CRT EAT-10 score ≥3 (P < .001). The mean post-CRT Penetration-Aspiration Scale score was 2.2 ± 1.5 for individuals with a pre-CRT EAT-10 score <3 and 3.8 ± 2.6 for those with a pre-CRT EAT-10 score ≥3 (P < .001). After multivariate analysis adjusting for age, tumor subsite, T classification, and primary surgery, pre-CRT dysphagia (EAT-10 ≥3) was an independent predictor of post-CRT aspiration (odds ratio, 4.19 [95% CI, 1.08-16.20]; P = .04) and feeding tube dependence (odds ratio, 3.54 [95% CI, 1.01-12.33]; P = .04). CONCLUSION: The presence of dysphagia before chemoradiation for head and neck cancer is an independent predictor of swallowing dysfunction after completion of therapy. These results may help target intervention toward preventing swallowing dysfunction in high-risk individuals.

Predictors of Aspiration Pneumonia and Mortality in Patients with Dysphagia.

OBJECTIVES/HYPOTHESIS: To identify risk factors for pneumonia incidence in patients with dysphagia undergoing a videofluoroscopic swallow study (VFSS) in an outpatient tertiary-care center. STUDY DESIGN: Historical cohort study. METHODS: All individuals undergoing a VFSS between 10/02/13 and 07/30/15 were identified and followed historically for 2 years. Demographic information, medical history, and fluoroscopic data were collected. The 2-year incidence of pneumonia was obtained from the medical records and telephone interview. The incidence of pneumonia and death were calculated and risk factors for pneumonia and mortality were ascertained. RESULTS: 689 patients were followed for 2 years. The mean age (±standard deviation) of the cohort was 65 (±15.5) years. 49% (338/689) were female. The most common causes of dysphagia were cricopharyngeus muscle dysfunction (270/689), head and neck cancer (175/689), and neurodegenerative disease (56/689). The incidence of pneumonia was 22% (153/689). The incidence of death was 11%. Multivariable logistic regression revealed that chronic obstructive pulmonary disorder [COPD] (odds ratio [OR] = 2.36, 95% confidence interval [CI]: 1.33-4.19), hypertension (OR = 1.82, 95% CI: 1.23-2.73), tracheotomy status (OR = 2.96, 95% CI: 1.09-7.99), and vallecular residue (OR = 1.88, 95% CI: 1.24-2.85) were all significantly associated with an elevated risk of pneumonia. Kidney disease (OR = 1.27, 95% CI: 1.02-9.9), COPD (OR = 3.27, 95% CI: 1.65-6.49), vallecular residue (OR = 2.35, 95% CI: 1.35-4.1), male gender (OR = 2.21, 95% CI: 1.25-3.92), and low body mass index (OR: 1.12, 95% CI: 1.06-1.19) were independent adjusted risk factors for death. CONCLUSIONS: The incidence of aspiration pneumonia (22%) and death (11%) within 2-years of a VFSS was high. The greatest adjusted risk factors for incident pneumonia were tracheotomy (OR = 3.0), COPD (OR = 2.4) and vallecular residue (OR = 1.9). The greatest adjusted risk factors for death were COPD (OR = 3.3), vallecular residue (OR = 2.3), and male gender (OR = 2.2). LEVEL OF EVIDENCE: 4 Laryngoscope, 132:1172-1176, 2022.

Endoscopic visualization for tracheoesophageal puncture tract sizing.

BACKGROUND: Accurate tracheoesophageal prosthesis (TEP) size is essential for optimal functioning. Current sizing techniques do not afford direct visualization. The clinical utility of direct visualization with unsedated transnasal esophagoscopy (TNE) to improve TEP sizing accuracy has not been established. AIMS/OBJECTIVES: The purpose of this investigation was to determine if endoscopic visualization with TNE during TEP fitting improves sizing accuracy. MATERIAL AND METHODS: Participants undergoing secondary TEP placement had their TEP sized without visualization and with visualization during TNE. The effect of endoscopic visualization on TEP sizing was assessed. RESULTS: The mean age (SD) of the cohort (N = 15) was 61.20 (±10.19) years. The percent disagreement between non-visualized and endoscopic-visualized puncture tract measurement was 60%. The mean difference in puncture tract length with visualization compared to without visualization was 1.75 mm (±1.91). Discordance between non-visualized and endoscopic-visualized puncture tract length was worse for persons with a history of radiation (66.7%) than without radiation (33.3%) (p < .05). The overall test agreement between endoscopic and non-endoscopic sizing techniques was moderate (Cohen's kappa coefficient = 0.254; (p < .05). CONCLUSION AND SIGNIFICANCE: The percent disagreement between non-visualized and endoscopic-visualized TEP sizing is high (60%). The data suggest that endoscopic visualization with TNE improves sizing accuracy during TEP placement.

Inflammatory Effects of Thickened Water on the Lungs in a Murine Model of Recurrent Aspiration.

OBJECTIVE: Liquid thickeners are commonly recommended in individuals with dysphagia and recurrent aspiration as a strategy for pneumonia prevention. The goal of this study was to examine the effects of small amounts of aspirated liquid thickener on the lungs. STUDY DESIGN: Animal model. Prospective small animal clinical trial. METHODS: Adult Sprague Dawley rats (n = 19) were divided into two groups and underwent three intratracheal instillations of either xanthan gum-based nectar-thick water (0.1-0.25 mL/kg) or water-only control over the course of 8 days. Blood was collected from a peripheral vein on days 1 and 8 and submitted for complete blood count (CBC) analysis. Rats were euthanized 10 days after the last instillation, and the lungs were harvested. Histopathology was conducted on lung specimens by a blinded licensed veterinary pathologist and scored for evidence of lung injury and pneumonia. RESULTS: Fifteen animals (8 nectar-thickener group, 7 control group) survived until the endpoint of the study (day 18). Serum CBC did not show abnormalities at any timepoint in either group. Histological evidence of lung inflammation and edema were significantly greater in the nectar-thick group compared to controls (P < .05). Signs of inflammation included aggregates of foamy macrophages, expansion of bronchiolar lymphoid tissue, and large numbers of eosinophilic intraalveolar crystals. Histiocytic and neutrophilic pneumonia was noted in one animal that received thickened liquids. CONCLUSION: Recurrent aspiration of small amounts of thickened water resulted in significant pulmonary inflammation in a murine model of aspiration. Results of this study support the need for further investigation of liquid thickener safety and its efficacy in reducing the pulmonary complications of swallowing disorders. LEVEL OF EVIDENCE: NA Laryngoscope, 131:1223-1228, 2021.

Esophageal Dysmotility is Common in Patients With Multiple System Atrophy.

OBJECTIVES: Esophageal dysmotility (ED) in patients with multiple system atrophy (MSA) are poorly understood. This study aimed to investigate the prevalence of ED in patients with MSA and to assess the relationship of esophageal abnormalities with other clinical findings and characteristics in these patients. METHODS: A retrospective chart review was conducted to identify patients with MSA and to compare them to the elderly controls without MSA (65+ years) who underwent a videofluorographic esophagram from 2014 to 2019. Disease type, disease severity, vocal fold mobility impairment, abnormal deglutitive proximal esophageal contraction (ADPEC), and intra-esophageal stasis (IES) were reviewed and compared between groups. RESULTS: Thirty-seven patients with MSA were identified. The median age was 63 and 26 (70%) were male. These patients were matched to 22 elderly adults with presbylarynx but not MSA (median age 77, 68% male). In MSA patients, cerebellar variant type was predominant (59%), and ADPEC was recognized in 18 patients (49%). Disease severity level (P = 0.028) and existence of IES (P = 0.046) were associated with higher risks of developing ADPEC. The prevalence of IES was significantly higher in patients with MSA (95%) compared to controls without MSA (46%) (P < 0.001). Disease severity level and the existence of IES were significantly associated with the presence of ADPEC (p < 0.05). CONCLUSION: ADPEC and IES were significantly more common in MSA than in elderly subjects without MSA. MSA severity is associated with the development of ADPEC. The data suggest that esophageal motility is predominantly affected in MSA. LEVEL OF EVIDENCE: 3 Laryngoscope, 131:832-838, 2021.

Cervical Fibrosis as a Predictor of Dysphagia.

OBJECTIVE: Radiotherapy of head and neck cancer (HNCA) causes dysfunction through radiation-induced fibrosis (RIF). We hypothesize that the degree of cervical fibrosis is associated with swallowing dysfunction. This study evaluated the association between cervical fibrosis and swallowing dysfunction in patients after radiation therapy for HNCA. STUDY DESIGN: Cross sectional study. METHODOLOGY: A convenience sample of patients with dysphagia who were at least 1 year post radiation therapy for HNCA underwent simultaneous cervical ultrasound (US) and video-fluroscopic swallow study (VFSS). US determinants of fibrosis were measurements of sternocleidomastoid fascia (SCMF) thickness bilaterally at the level of the cricoid. Primary and secondary outcome variables on VFSS were pharyngeal constriction ratio, a validated measure of pharyngeal contractility, and penetration aspiration scale (PAS). A qualitative assessment of lateral neck rotation was performed as a functional measure of neck fibrosis. RESULTS: Simultaneous cervical US and VFSS examinations were performed on 18 patients with a history of radiotherapy for HNCA and on eight controls. The mean (±SD) age of the entire cohort (N = 26) was 66 (±10) years. Individuals with a history of radiation had significantly thinner mean SCMF (0.26 [±0.04 mm]) compared to controls (0.48 [±0.06 mm]; P < .05). Individuals with thinner SCMF were more likely to have moderate to severe restriction in lateral neck rotation, a higher PCR, and a higher PAS (P < .05). CONCLUSION: Thinner sternocleidomastoid fascia on ultrasound in patients having undergone radiotherapy for head and neck cancer was associated with reduced lateral neck movement, poorer pharyngeal constriction and greater penetration/aspiration scale. The data suggest that cervical fibrosis is associated with swallowing dysfunction in head and neck cancer survivors and support the notion that, "As the neck goes, so does the swallow." LEVEL OF EVIDENCE: 3. Laryngoscope, 131:548-552, 2021.