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.

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.

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.

The effects of barium concentration levels on the pulmonary inflammatory response in a rat model of aspiration.

PURPOSE: Barium sulfate (Ba) suspension is the most widely used contrast agent for upper gastrointestinal and videofluoroscopic swallow studies (VFSS). The effect of Ba concentration on lung injury is uncertain. The aims of this study were to explore the effects of different barium concentrations on the respiratory organs and elucidate the underlying mechanisms of these effects in an established animal model of aspiration. METHODS: Animal model study. Eight-week-old male Sprague-Dawley rats were allocated into three groups (n = 12, each group). Two groups underwent tracheal instillation of low (30% w/v) and high (60% w/v) concentration Ba (low-Ba, high-Ba). A control group was instilled with saline. Half of the animals were euthanized on day 2 and the remaining half were euthanized on day 30. Histological and gene analyses were performed. RESULTS: Both low-Ba and high-Ba aspiration caused inflammatory cell infiltration in the lung at 2 days post aspiration with an increase in the expression of inflammatory cytokines. At 30 days post aspiration, small quantities of barium particles remained in the lung of the low-Ba group without any inflammatory reaction. Chronic inflammation was recognized in the high-Ba group up to 30 days post aspiration. CONCLUSION: A small amount of high concentration Ba (60% w/v) caused sustained inflammation in the rat lung at least 30 days after aspiration. Even with a small amount of low concentration Ba aspiration (30% w/v), Ba particles can remain in the lung over a month, causing sustained late effects.

The Relationship Between Hiatal Hernia and Cricopharyngeus Muscle Dysfunction.

Although the precise etiology of cricopharyngeus muscle (CPM) dysfunction (CPMD) is uncertain, many have hypothesized that a hypertrophied CPM may develop as a protective compensation against gastroesophageal reflux disease (GERD). The purpose of this investigation was to evaluate the association between CPMD and the presence of hiatal hernia (HH) in an attempt to elucidate the potential etiology of CPMD. The charts of individuals who underwent video fluoroscopic esophagrams between 01/01/14 and 10/30/16 were reviewed from an electronic database. A group of 50 subjects with reported HH were identified and age- and gender-matched to an individual without HH. The prevalence of CPMD was compared between groups. The mean (± SD) age of the HH cohort was 64 (± 13.4) years and 64 (± 12.8) years for the group without HH (p > 0.05). Thirty-eight percent was male. The frequency of CPMD in the HH group was 78% versus 58% in the non-HH group (p < 0.05). Individuals with a HH were 2.57 times more likely to have evidence of CPMD (95% CI 1.07- 6.15). Although these data suggest an association between GERD and CPMD, further research is required before a causal relationship can be presumed.

Total laryngectomy for management of chronic aspiration pneumonia in a myopathic dog.

A 5-month-old female pit bull terrier dog evaluated for ataxia, progressive regurgitation, and recurrent aspiration pneumonia had markedly elevated creatine kinase activity, non-inflammatory generalized myopathy, and severe esophageal dysmotility. A narrow-field total laryngectomy was performed. The dog is doing well 30 months after surgery, and no longer has episodes of aspiration pneumonia, despite intermittent regurgitation. This case represents the first application of total laryngectomy for the prevention of chronic recurrent aspiration pneumonia in the dog.

Laryngectomie totale pour la gestion d'une pneumonie par aspiration chronique chez un chien myopathique. Une chienne Pit Bull Terrier âgée de 5 mois évaluée pour de l'ataxie, de la régurgitation progressive et une pneumonie par aspiration récurrente présentait une activité de la créatine kinase particulièrement élevée, une myopathie généralisée non inflammatoire et un trouble de motilité de l'œsophage grave. Une laryngectomie totale à champ étroit a été réalisée. La chienne se porte bien 30 mois après la chirurgie et n'a plus d'épisodes de pneumonie par aspiration, malgré une régurgitation intermittente. Ce cas représente la première application d'une laryngectomie totale pour la prévention d'une pneumonie par aspiration chronique récurrente chez un chien.(Traduit par Isabelle Vallières).

The Ability of the 10-Item Eating Assessment Tool (EAT-10) to Predict Aspiration Risk in Persons With Dysphagia.

BACKGROUND: Dysphagia is common and costly. The ability of patient symptoms to predict objective swallowing dysfunction is uncertain. PURPOSE: This study aimed to evaluate the ability of the Eating Assessment Tool (EAT-10) to screen for aspiration risk in patients with dysphagia. METHODS: Data from individuals with dysphagia undergoing a videofluoroscopic swallow study between January 2012 and July 2013 were abstracted from a clinical database. Data included the EAT-10, Penetration Aspiration Scale (PAS), total pharyngeal transit (TPT) time, and underlying diagnoses. Bivariate linear correlation analysis, sensitivity, specificity, and predictive values were calculated. RESULTS: The mean age of the entire cohort (N=360) was 64.40 (±14.75) years. Forty-six percent were female. The mean EAT-10 was 16.08 (±10.25) for nonaspirators and 23.16 (±10.88) for aspirators (P<.0001). There was a linear correlation between the total EAT-10 score and the PAS (r=0.273, P<.001). Sensitivity and specificity of an EAT-10>15 in predicting aspiration were 71% and 53%, respectively. CONCLUSION: Subjective dysphagia symptoms as documented with the EAT-10 can predict aspiration risk. A linear correlation exists between the EAT-10 and aspiration events (PAS) and aspiration risk (TPT time). Persons with an EAT-10>15 are 2.2 times more likely to aspirate (95% confidence interval, 1.3907-3.6245). The sensitivity of an EAT-10>15 is 71%.

Evaluation of hypopharyngeal suction to eliminate aspiration: the Retro-Esophageal Suction (REScue) catheter.

Profound oropharyngeal dysphagia (OPD) is common and costly. Treatment options are limited. The purpose of this investigation was to evaluate the utility of hypopharyngeal suction at the upper esophageal sphincter (UES) to eliminate aspiration. Five different catheters were passed retrograde up the esophagus and positioned at the UES in a cadaver model of profound OPD. Suction was affixed to each catheter. 10 cc of barium was administered into the pyriform sinus, and videofluoroscopy was utilized to evaluate the presence of aspiration. 6 trials were administered per catheter and for a no catheter control. The outcome measures were the incidence of aspiration, the NIH Swallow Safety Scale (NIH-SSS), and UES opening. Control trials with no suction resulted in an aspiration rate of 100 % (6/6 trials). Negative pressure through 16, 18, 24, and 30 Fr catheter resulted in an aspiration rate of 0 % (0/24 trials; p < 0.001), and suction through a 12-Fr catheter resulted in an aspiration rate of 33 % (2/6 trials; p > 0.05). The mean NIH-SSS improved from 7.0 (±0.0) in the control to 0 (±0.0) with hypopharyngeal suction (18 Fr nasogastric catheter; p < 0.001). Mean UES opening improved from 0.0 (±0.0) mm in the control condition to 8.6 (±0.2) mm with a hypopharyngeal catheter (16 Fr Foley catheter; p < 0.001). Negative pressure applied through retro-esophageal suction catheters (>12 Fr) at the level of the UES reduced aspiration by 100 % and significantly increased UES opening in a cadaveric model of profound oropharyngeal dysphagia.

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.

Tracheotomy tubes with suction above the cuff reduce the rate of ventilator-associated pneumonia in intensive care unit patients.

OBJECTIVES: We evaluated the effect of tracheotomy tubes that enable suction immediately above the cuff on the development of ventilator-associated pneumonia (VAP). METHODS: Patients without preexisting pneumonia who required tracheotomy were randomly assigned to receive a tracheotomy tube with or without above-the-cuff suction. The suction tube provided 10 mm Hg of continuous wall suction while the tracheotomy tube cuff was inflated. Data regarding the development of VAP, time on the ventilator, and length of stay in the intensive care unit (ICU) were recorded and compared between groups. RESULTS: Eighteen patients were randomized and prospectively evaluated. Nine patients received standard tracheotomy tubes, and 9 received suction-above-the-cuff tracheotomy tubes. The prevalences of VAP were 56% in the control group and 11% in the suction tracheotomy group (p = 0.02). The mean times on the ventilator were 18 +/- 14 days in the control group and 11 +/- 11 days in the suction group (p = 0.12). The mean lengths of ICU stay were 26 +/- 15 days in the control group and 18 +/- 15 days in the suction group (p = 0.14). CONCLUSIONS: Use of suction-above-the-cuff tracheotomy tubes significantly decreases the incidence of VAP in ICU patients. There were trends toward decreased time on the ventilator and decreased length of stay in the ICU.

The upper esophageal sphincter is not round: a pilot study evaluating a novel, physiology-based approach to upper esophageal sphincter dilation.

OBJECTIVES: Recent basic science investigations have suggested that the upper esophageal sphincter (UES), in cross section, is not round, but that it more closely approximates a kidney shape. Dilation with simultaneous use of two cylindrical dilators provides a novel, physiology-based approach to UES distention. We evaluated the initial safety and efficacy of UES dilation with simultaneous use of two controlled radial expansion balloon dilators. METHODS: Using a computerized database, we reviewed the charts of all persons who underwent UES dilation with simultaneous use of two radial expansion balloon dilators between December 1, 2011, and March 15, 2012. Information regarding patient demographics, indications, technique, and complications was abstracted. Self-reported swallowing impairment was assessed with the validated 10-item Eating Assessment Tool (EAT-10). RESULTS: Ten individuals underwent simultaneous dilation with two dilators. Their mean age was 65 years (SD, 14 years), and 7 (70%) of them were male. The indications for dilation were radiation-induced UES stenosis (50%), cricopharyngeus muscle dysfunction (30%), upper esophageal web (10%), and anastomotic stricture (10%). After the double-balloon dilation, no complications were reported. The mean EAT-10 score improved significantly, from 34.3 (SD, 13.5) to 16.7 (SD, 8.4), after the simultaneous dilation (p = 0.003). CONCLUSIONS: Pilot data suggest that simultaneous dilation of the UES with two controlled radial expansion balloon dilators is feasible, safe, and effective. Future investigation is necessary to confirm the safety of this technique in a larger cohort and to use objective measures of efficacy to compare the technique to conventional dilation with a single dilator.

A bibliometric review of published abstracts presented at the Dysphagia Research Society: 2001-2011.

The purpose of this investigation was to perform a comprehensive bibliometric review of published abstracts presented at the Dysphagia Research Society between 2001 and 2011 in order to delineate research trends, identify knowledge gaps, and recommend areas for future dysphagia research. All 972 research abstracts, both oral and poster presentations, were included. Study designs included cross-sectional (n = 333, 34.4 %), cohort (n = 279, 28.8 %), and case series (n = 210, 21.7 %), while randomized controlled trials constituted only 3.3 % (n = 32) of all research presentations. Levels of evidence were assigned based on analysis of abstract details, as level 1 (n = 29, 3.0 %), level 2 (n = 639, 65.7 %), level 3 (n = 53, 5.5 %), level 4 (n = 243, 25.0 %), and level 5 (n = 8, 0.8 %). Research topics included normal swallowing pathophysiology (n = 279, 28.7 %), swallowing physiology (n = 266, 27.4 %), swallowing diagnosis (n = 192, 19.7 %), swallowing treatment (n = 165, 17.0 %), clinical policy and practice (n = 36, 3.7 %), and basic science (n = 34, 3.5 %). Research occurred in adults (n = 861, 88.6 %), pediatrics (n = 76, 7.8 %), animals (n = 29, 3.0 %), cadavers (n = 3, 0.3 %), and mechanical models (n = 3, 0.3 %). Presenting authors represented 14 different disciplines, with the majority in speech-language pathology, dentistry, basic science, and otolaryngology. Research was performed in 14 different countries with increased geographical diversity during the decade of analysis. Research recommendations derived from our findings call for increased (1) randomized controlled clinical trials consistent with level 1 evidence, (2) focus on pediatric feeding and swallowing, (3) use of animal models to study swallowing dysfunction and novel treatments, and (4) investigations from additional medical specialties. In addition, we applaud current trends and encourage continued support of interdisciplinary, international, and trainee representation.

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.

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.

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.

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.

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.