Functional Laryngectomy and Quality of Life in Survivors of Head and Neck Cancer With Intractable Aspiration.

Importance: Late effects of head and neck cancer (HNC) treatment include profound dysphagia, chronic aspiration, and death. Functional laryngectomy (FL) can improve patient survival and quality of life (QoL); however, removing a failing larynx for a noncancer reason is a difficult decision. Data regarding the ability of FL to improve self-perceptions of voice, swallowing, and QOL in survivors of HNC with intractable aspiration are inconclusive. Objective: To investigate the association of FL with changes in self-reported perceptions of voice, swallowing, oral intake, QoL, and mood in survivors of HNC experiencing profound dysphagia and intractable aspiration. Design, Settings, and Participants: This cohort study was conducted at a single academic institution and included survivors of HNC with profound swallowing dysfunction and intractable aspiration who underwent FL from July 2016 through March 2022. Of the initial 22 patients enrolled, 2 patients (15%) died of aspiration pneumonia before receiving FL. Data analyses were performed from July 2016 through March 2023. Main Outcomes and Measures: Self-reported measures of voice using the VHI (30-item Voice Handicap Index), swallowing using the EAT-10 (10-item Eating Assessment Tool), functional oral intake scale using the FOIS (Functional Oral Intake Scale), and quality of life using the FACT-H&N (Functional Assessment of Cancer Therapy-Head & Neck) were assessed before FL and at 1, 3, and 6 months after FL. Mood states were evaluated using the POMS (Profile of Mood States, second edition), before FL and at 6 months after FL. Results: The study analyses included 20 patients (mean [SD] age, 72.4 (7.0) years; 19 [95%] males and 1 [5%] female) who underwent FL and had complete data across all time points. Among these, 12 patients (60%) had received chemoradiation for oropharyngeal, 7 (35%) for laryngeal, or 1 (5%) for nasopharyngeal cancer. The mean (SD) time from completion of oncologic treatment to FL was 15.5 (5.5) years. Mean (SD) score on the EAT-10 improved from 33.2 (7.4) to 23.1 (10.8) at 1 month; 12.1 (9.1) at 3 months; and 8.3 (7.4) at 6 months, with a large effect size (η2 = 0.72; 95% CI, 0.54-0.80). Mean (SD) score on the FOIS improved from 2.0 (1.5) to 2.9 (1.7) at 1 month; 4.8 (2.5) at 3 months; and 5.2 (1.7) at 6 months, with a large effect size (η2 = 0.6; 95% CI, 0.38-0.71). Improvement in oral intake was achieved in 19 patients (95%), and feeding tubes were removed in 10 of 16 patients (63%) who were feeding tube-dependent; 6 patients (27%) continued to require supplemental tube feedings. Mean (SD) score on the VHI improved from 63.6 (34.0) to 86.9 (33.7) at 1 month; 71.3 (36.1) at 3 months; and 39.7 (26.9) at 6 months, with a large effect size (η2 = 0.42; 95% CI, 0.19-0.56). Seventeen patients (85%) were able to use a tracheoesophageal voice prosthesis for alaryngeal communication. Mean (SD) score on the FACT-H&N improved from 86.2 (17.8) to 93.6 (18.4) at 1 month; 109.0 (18.4) at 3 months; and 121.0 (16.8) at 6 months, with a large effect size (η2 = 0.64; 95% CI, 0.42-0.74). Mean (SD) score on the POMS improved from 58.9 (13.2) at baseline to 44.5 (9.9) at 6 months, with a large effect size (Cohen d = 1.04; 95% CI, 0.48-1.57). None of the patients experienced major complications of FL; 1 patient (5%) had a postoperative pharyngocutaneous fistula. Conclusions and Relevance: The findings of this cohort study indicate that FL was associated with marked improvements in self-perception of voice and swallowing, functional oral intake, QoL, and mood state among survivors of HNC. These findings can serve as a framework for FL counseling among HNC survivors experiencing profound dysphagia and intractable aspiration.

Surgical Outcomes in Zenker Diverticula: A Multicenter, Prospective, Longitudinal Study.

OBJECTIVE: To compare improvement in patient-reported outcomes (PROM) in persons undergoing endoscopic and open surgical management of Zenker diverticula (ZD). METHODOLOGY: Prospective, multicenter cohort study of all individuals enrolled in the Prospective OUtcomes of Cricopharyngeus Hypertonicity (POUCH) Collaborative who underwent surgery for ZD. Patient survey, radiography reports, and the 10-item Eating Assessment Tool (EAT-10) pre- and post-procedure were abstracted from a REDCap database, which summarized means, medians, percentages, and frequencies of. Outcome based on operative intervention (endoscopic vs. open) was compared using t-test, Wilcoxon rank sum test or chi-square test, as appropriate. RESULTS: One hundred and forty-seven persons were prospectively followed. The mean age (SD) of the cohort was 68.7 (11.0). Overall, 66% of patients reported 100% improvement in EAT-10; 81% of patients had greater than 75% improvement; and 88% had greater than 50% improvement. Endoscopic was used for n = 109 patients, and open surgical intervention was used for n = 38. The median [interquartile range, IQR] EAT-10 percent improvement for endoscopic treatment was 93.3% [72, 100], and open was 100% [92.3, 100] (p = 0.05). The incidence of intraoperative complications was 3.7% for endoscopic and 7.9% for open surgical management. The median [IQR] in follow-up was 86 and 97.5 days, respectively. CONCLUSION: Both endoscopic and open surgical management of ZD provide significant improvement in patient-reported outcomes. The data suggest that open diverticulectomy may provide a modest advantage in symptomatic improvement compared to endoscopic management. The data suggest that the postoperative complication rate is higher in the open surgical group. LEVEL OF EVIDENCE: 3 Laryngoscope, 134:97-102, 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.

Postoperative Care of Zenker Diverticula: Contemporary Perspective from the Prospective OUtcomes Cricopharyngeaus Hypertonicity (POUCH) Collaborative.

OBJECTIVES: The aim of the study was to identify trends in postoperative management of persons undergoing surgery for Zenker diverticula (ZD) by evaluating length of stay (LOS), diet on discharge, and imaging with or without surgical complication. METHODS: Prospectively enrolled adult patients with cricopharyngeal muscle dysfunction with diverticula undergoing surgery from August 1, 2017 to February 1, 2023 were included. Data were extracted from a multi-institutional REDCap database, summarizing means, medians, percentages, and frequencies. Fisher's exact or chi squared analyses were utilized, as appropriate, to compare subsets of data. Descriptive analysis assessed differences in clinical course and the relationship to postoperative management. RESULTS: There were 298 patients with a mean (standard deviation) age of 71.8 (11.2) years and 60% male. Endoscopic surgery was performed in 79.5% (237/298) of patients versus 20.5% (61/298) open surgery. Sixty patients (20.1%) received postoperative imaging, with four leaks identified. Complications were identified in 9.4% of cases (n = 29 complications in 28 patients), more commonly in open surgery. Most (81.2%) patients were discharged within 23 h. About half of patients (49%) were discharged from the hospital on a pureed/liquid diet; 36% had been advanced to a soft diet. In patients without complications, LOS was significantly longer following open cases (p = 0.002); postoperative diet was not different between open and endoscopic (p = 0.26). CONCLUSIONS: Overall, most patients are discharged within 23 h without imaging. However, LOS was affected by surgical approach. Postoperative complications are different in endoscopic versus open surgery. Complications with either approach were associated with prolonged LOS, need for imaging, and diet restriction. LEVEL OF EVIDENCE: Level III Laryngoscope, 134:2678-2683, 2024.

Validation and cross-cultural adaptation of the Italian version of the paediatric eating assessment tool (I-PEDI-EAT-10) in genetic syndromes.

BACKGROUND: The Pediatric Eating Assessment Tool (PEDI-EAT-10) is a reliable and valid tool for rapid identification of dysphagia in patients aged 18 months to 18 years. AIMS: To translate and adapt the PEDI-EAT-10 into the Italian language and evaluate its validity and reliability. METHODS & PROCEDURES: The translation and cross-cultural adaptation of the tool consisted of five stages: initial translation, synthesis of the translations, back translation, expert committee evaluation and test of the prefinal version. The internal consistency of the translated tool was analysed in a clinical group composed of 200 patients with special healthcare needs aged between 18 months and 18 years. They were consecutively enrolled at the Rare Disease Unit, Paediatrics Department, Fondazione Policlinico Agostino Gemelli-IRCCS, Rome. For test-retest reliability, 50 caregivers filled in the PEDI-EAT-10 questionnaire for a second time after a 2-week period. Construct validity was established by comparing data obtained from patients with data from healthy participants (n = 200). The study was approved by the local ethics committee. OUTCOMES & RESULTS: Psychometric data obtained from patients (104 M; mean age = 8.08 ± 4.85 years; median age = 7 years) showed satisfactory internal consistency (Cronbach's α = 0.89) and test-retest reliability (Pearson r = 0.99; Spearman r = 0.96). A total of 30% of children were classified as having a high risk of penetration/aspiration. The Italian PEDI-EAT-10 mean total score of the clinical group was significantly different from that resulting from healthy participants. CONCLUSIONS & IMPLICATIONS: The PEDI-EAT-10 was successfully translated into Italian, validated and found to be a reliable one-page rapid screening tool to identify dysphagia in children and adolescents with special needs. WHAT THIS PAPER ADDS: What is already known on the subject The PEDI-EAT-10 is a valid and reliable quick discriminative paediatric tool for identifying penetration/aspiration risks. What this paper adds to the existing knowledge In the present study we successfully translated and adapted the PEDI-EAT-10 into the Italian language. What are the potential or actual clinical implications of this work? This translation and adaptation increase access to valid feeding and swallowing assessment for children of Italian-speaking families. In addition, the I-PEDI-EAT-10 can suggest further assessment of patients' swallowing abilities.

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.

The efficacy of two commercially available devices for airway foreign body relief: A cadaver study.

Objective: Foreign body aspiration events are frequent in young children and in the geriatric population. They may result in several complications such as hypoxia, edema, cardiac arrest, and death. Recently, two commercially available devices, the LifeVac and DeChoker, have entered the market with the claim of relieving foreign body aspiration. Both devices are portable, nonpowered, suction devices that are being considered for use in large public spaces such as schools, airports, and malls despite previous studies detailing variable efficacy. In this study, we aim to contribute further data on the safety and efficacy of these devices through a fresh cadaver model. Methods: Commonly aspirated foods of three different sizes (saltines, grapes, and cashews) were placed at the level of the true vocal folds in a fresh cadaver. Three participants performed two trials with each food and device. Device use was performed to manufacturer specifications. Results: The DeChoker resulted in gross injury to the tongue and failed to remove the obstruction in all trials. LifeVac was successful in removing the barium-moistened saltines but failed to remove all other foreign bodies. Both devices applied significant pressure to the tongue. Conclusion: With the exception of the LifeVac removing saltine crackers, all trials were entirely unsuccessful in relieving foreign body aspiration. Additionally, both devices may cause significant pressure and injury to the oral cavity in a clinical setting. We conclude bystanders should continue to follow International Liaison Committee on Resuscitation's guidelines on resuscitation to aid with relieving foreign body aspiration. Level of Evidence: 4.

Can EAT-10 Become EAT-5? Improving Measurement Efficiency of Dysphagia with Item Response Theory.

OBJECTIVES: To assess: (1) the Eating Assessment Tool (EAT-10) with item response theory (IRT) to determine which individual items provide the most information, (2) the extent to which dysphagia is measured with subsets of items while maintaining precise score estimates, and (3) if 5-item scales have the differing discriminatory ability, as compared to the parent 10-item instrument. METHODS: Prospectively collected data from 2,339 patients who completed the EAT-10 questionnaire during evaluation at a tertiary care otolaryngology clinic were utilized. IRT analyses provided discrimination and location parameters associated with individual questions. Residual item correlations were also assessed for redundant information. Based on these results, three 5-item subsets were further evaluated using item information function curves. Areas under receiver-operator characteristic curves (ROC-AUC) were also calculated to evaluate the discriminatory ability for dysphagia-related clinical diagnoses. RESULTS: Item discrimination parameter estimates ranged from 1.71 to 5.46, with higher values indicating more information. Residual item correlations were determined within item pairs, and location parameters were calculated. Based on these data, in combination with clinical utility, three 5-item subsets were proposed and assessed. ROC-AUC analyses demonstrated no significant difference between the EAT-5-Alpha subset and the original 10-item instrument for discriminating dysphagia as a primary diagnosis (0.88, 0.88). The EAT-5-Clinical subset outperformed the original 10 instruments in ROC-AUC for aspiration. The EAT-5-Range subset was significantly associated with problems with thin liquids. CONCLUSIONS: IRT analyses distinguished three proposed 5-item subsets of the EAT-10 instrument, supporting shorter survey options, while still reflecting the impact of dysphagia without significant loss of discrimination. LEVEL OF EVIDENCE: 3 (Diagnostic testing with consistently applied reference standards, partial blinding). Laryngoscope, 133:3327-3333, 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.

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.

Tongue base augmentation to improve swallow function in a cadaveric model.

Objectives: To evaluate the feasibility of using Calcium Hydroxylapatite (CaHA) to augment the tongue base for patients with swallowing impairment due to tongue base atrophy. Methods: A fresh human cadaver was obtained through the institution's body donation program and baseline lateral fluoroscopic images were obtained. A total of 2 mL of CaHA (Prolaryn Plus) were injected into three sites of the base of tongue under flexible endoscopic guidance with a 22G, 1.5-inch needle (Monoject, Cardinal Health). Post-lateral fluoroscopic images were obtained and pharyngeal area (cm2) and tongue base to pharyngeal wall distance (cm) was measured pre- and postinjection using SwallowTail fluoroscopic measurement software (Belldev Medical). Results: The procedure was easily performed and the CaHA flowed easily into the cadaveric tongue without evidence of extrusion. The pre-procedural pharyngeal area decreased from 24.36 to 23.14 cm after augmentation. The base of tongue to pharyngeal wall distance decreased from 2.21 to 1.32 cm after augmentation. Conclusion: Tongue base augmentation with CaHA may be a feasible adjuvant therapy for the management of swallowing impairment secondary to tongue base atrophy. Further investigation is necessary to evaluate the clinical safety and efficacy. Level of Evidence: 4.

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.

Killian Jamieson Diverticulum, the Great Mimicker: A Case Series and Contemporary Review.

OBJECTIVE: To assess barium esophagram (BAS) as a diagnostic marker for patients with Killian Jamieson diverticula (KJD). METHODS: Prospective, multicenter cohort study of individuals enrolled in the Prospective OUtcomes of Cricopharyngeus Hypertonicity (POUCH) Collaborative. Patient demographics, comorbidities, radiographic imaging reports, laryngoscopy findings, patient-reported outcome measures (PROM), and operative reporting were abstracted from a REDCap database and summarized using means, medians, percentages, frequencies. Paired t-tests and Wilcoxon Signed Rank test were used to test pre- to post-operative differences in RSI, EAT-10, and VHI-10 scores. Diagnostic test evaluation including sensitivity, specificity, positive, and negative predictive value with 95% confidence intervals were calculated comparing BAS findings to operative report. RESULTS: A total of 287 persons were enrolled; 13 (4%) patients were identified with confirmed KJD on operative reports. 100% underwent open transcervical excision. BAS has a 46.2% (95% confidence interval [CI]: 23.2, 70.9) sensitivity and 97.8% (95% CI: 95.3, 99.0) specificity in detecting a KJD and 50% (95% CI: 25.4, 74.6) positive predictive value but 97.4% (95%CI: 94.8, 98.7) negative predictive value. Preoperatively, patients reported mean (SD) RSI and EAT-10 of 19.4 (9) and 8.3 (7.5) accordingly. Postoperatively, patients reported mean (SD) RSI and EAT-10 as 5.4 (6.2) and 2.3 (3.3). Both changes in RSI and EAT-10 were statistically significant (p = 0.008, p = 0.03). CONCLUSION: KJD are rare and represent <5% of hypopharyngeal diverticula undergoing surgical intervention. Open transcervical surgery significantly improves symptoms of dysphagia. BAS has high specificity but low sensitivity in detecting KJD. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:2110-2115, 2023.

The American Broncho-Esophagological Association Position Statement on Swallowing Fluoroscopy.

OBJECTIVES: To develop an expert consensus statement on the clinical use of swallowing fluoroscopy in adults that reduces practice variation and identifies opportunities for quality improvement in the care of patients suffering from swallowing impairment. METHODOLOGY: A search strategist reviewed data sources (PubMed, Embase, Cochrane, Web of Science, Scopus) to use as evidence for an expert development group to compose statements focusing on areas of controversy regarding swallowing fluoroscopy. Candidate statements underwent two iterations of a modified Delphi protocol to reach consensus. RESULTS: A total of 2184 publications were identified for title and abstract review with 211 publications meeting the criteria for full text review. Of these, 148 articles were included for review. An additional 116 publications were also included after reviewing the references of the full text publications from the initial search. These 264 references guided the authors to develop 41 candidate statements in various categories. Forty statements encompassing patient selection, fluoroscopic study choice, radiation safety, clinical team dynamics, training requirements, videofluoroscopic swallow study and esophagram techniques, and interpretation of swallowing fluoroscopy met criteria for consensus. One statement on esophagram technique reached near-consensus. CONCLUSIONS: These 40 statements pertaining to the comprehensive use of swallowing fluoroscopy in adults can guide the development of best practices, improve quality and safety of care, and influence policy in both the outpatient and inpatient settings. The lack of consensus on some aspects of esophagram technique likely reflects gaps in knowledge and clinical practice variation and should be a target for future research. Laryngoscope, 133:255-268, 2023.

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.

Cricopharyngeus Muscle Dysfunction and Hypopharyngeal Diverticula (e.g., Zenker): A Multicenter Study.

OBJECTIVE: To describe demographics and imaging and compare findings and symptoms at presentation in a large cohort of persons with cricopharyngeus muscle dysfunction (CPMD) with and without hypopharyngeal diverticula. METHODOLOGY: Prospective, multicenter cohort study of all individuals enrolled in the Prospective OUtcomes of Cricopharyngeal Hypertonicity (POUCH) Collaborative. Patient survey, comorbidities, radiography, laryngoscopy findings, and patient-reported outcome measures (e.g., Eating Assessment Tool [EAT-10]) data were abstracted from a REDCap database and summarized using means, medians, percentages, and frequencies. Diagnostic categories were compared using analysis of variance. RESULTS: A total of 250 persons were included. The mean age (standard deviation [SD]) of the cohort was 69.0 (11.2). Forty-two percent identified as female. Zenker diverticula (ZD) was diagnosed in 85.2%, 9.2% with CPMD without diverticula, 4.4% with a Killian Jamieson diverticula (KJD), and 1.2% traction-type diverticula. There were no differences between diagnostic categories in regard to age, gender, and duration of symptoms (p = 0.25, 0.19, 0.45). The mean (SD) EAT-10 score for each group was 17.1 (10.1) for ZD, 20.2 (9.3) for CPMD, and 10.3 (9.4) for KJD. Patients with isolated CPMD had significantly greater EAT-10 scores compared to the other diagnostic groups (p = 0.03). CONCLUSION: ZD is the most common, followed by CPMD without diverticula, KJD, and traction-type. Patients with isolated obstructing CPMD may be more symptomatic than persons with ZD or KJD. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:1349-1355, 2023.

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.