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.

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.

Factors Associated With Otolaryngologists Performing Tracheotomy.

Importance: Tracheotomies are frequently performed by nonotolaryngology services. The factors that determine which specialty performs the procedure are not defined in the literature but may be influenced by tracheotomy approach (open vs percutaneous) and other clinicodemographic factors. Objective: To evaluate demographic and clinical characteristics associated with tracheotomies performed by otolaryngologists compared with other specialists and to differentiate those factors from factors associated with use of open vs percutaneous tracheotomy. Design, Setting, and Participants: This multicenter, retrospective cohort study included patients aged 18 years or older who underwent a tracheotomy for cardiopulmonary failure at 1 of 8 US academic institutions between January 1, 2013, and December 31, 2016. Data were analyzed from September 2022 to July 2023. Exposure: Tracheotomy. Main Outcomes and Measures: The primary outcome was factors associated with an otolaryngologist performing tracheotomy. The secondary outcome was factors associated with use of the open tracheotomy technique. Results: A total of 2929 patients (mean [SD] age, 57.2 [17.2] years; 1751 [59.8%] male) who received a tracheotomy for cardiopulmonary failure (652 [22.3%] performed by otolaryngologists and 2277 [77.7%] by another service) were analyzed. Although 1664 of all tracheotomies (56.8%) were performed by an open approach, only 602 open tracheotomies (36.2%) were performed by otolaryngologists. Most tracheotomies performed by otolaryngologists (602 of 652 [92.3%]) used the open technique. Multivariable regression analysis revealed that self-reported Black race (odds ratio [OR], 1.89; 95% CI, 1.52-2.35), history of neck surgery (OR, 2.71; 95% CI, 2.06-3.57), antiplatelet and/or anticoagulation therapy (OR, 1.74; 95% CI, 1.29-2.36), and morbid obesity (OR, 1.54; 95% CI, 1.24-1.92) were associated with greater odds of an otolaryngologist performing tracheotomy. In contrast, history of neck surgery (OR, 1.36; 95% CI, 0.96-1.92), antiplatelet and/or anticoagulation therapy (OR, 0.80; 95% CI, 0.56-1.14), and morbid obesity (OR, 0.94; 95% CI, 0.74-1.19) were not associated with undergoing open tracheotomy when performed by any service, and Black race (OR, 0.56; 95% CI, 0.44-0.71) was associated with lesser odds of an open approach being used. Age-adjusted Charlson Comorbidity Index score greater than 4 was associated with greater odds of both an otolaryngologist performing tracheotomy (OR, 1.26; 95% CI, 1.03-1.53) and use of the open tracheotomy technique (OR, 1.48, 95% CI, 1.21-1.82). Conclusions and Relevance: In this study, otolaryngologists were significantly more likely than other specialists to perform a tracheotomy for patients with history of neck surgery, morbid obesity, and ongoing anticoagulation therapy. These findings suggest that patients undergoing tracheotomy performed by an otolaryngologist are more likely to present with complex and challenging clinical characteristics.

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.

Expert Consensus Statement: Management of Dysphagia in Head and Neck Cancer Patients.

OBJECTIVE: To develop an expert consensus statement (ECS) on the management of dysphagia in head and neck cancer (HNC) patients to address controversies and offer opportunities for quality improvement. Dysphagia in HNC was defined as swallowing impairment in patients with cancers of the nasal cavity, paranasal sinuses, nasopharynx, oral cavity, oropharynx, larynx, or hypopharynx. METHODS: Development group members with expertise in dysphagia followed established guidelines for developing ECS. A professional search strategist systematically reviewed the literature, and the best available evidence was used to compose consensus statements targeted at providers managing dysphagia in adult HNC populations. The development group prioritized topics where there was significant practice variation and topics that would improve the quality of HNC patient care if consensus were possible. RESULTS: The development group identified 60 candidate consensus statements, based on 75 initial proposed topics and questions, that focused on addressing the following high yield topics: (1) risk factors, (2) screening, (3) evaluation, (4) prevention, (5) interventions, and (6) surveillance. After 2 iterations of the Delphi survey and the removal of duplicative statements, 48 statements met the standardized definition for consensus; 12 statements were designated as no consensus. CONCLUSION: Expert consensus was achieved for 48 statements pertaining to risk factors, screening, evaluation, prevention, intervention, and surveillance for dysphagia in HNC patients. Clinicians can use these statements to improve quality of care, inform policy and protocols, and appreciate areas where there is no consensus. Future research, ideally randomized controlled trials, is warranted to address additional controversies related to dysphagia in HNC patients.

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.

Clinicodemographic Predictors of Tracheotomy Tube Size and Decannulation: A Multiinstitutional Retrospective Cohort Study on Tracheotomy.

OBJECTIVE: We aimed to discern clinico-demographic predictors of large (≥8) tracheostomy tube size placement, and, secondarily, to assess the effect of large tracheostomy tube size and other parameters on odds of decannulation before hospital discharge. SUMMARY OF BACKGROUND DATA: Factors determining choice of tracheostomy tube size are not well-characterized in the current literature, despite evidence linking large tracheostomy tube size with posttracheotomy tracheal stenosis. The effect of tracheostomy tube size on timing of decannulation is also unknown, an important consideration given reported associations between endotracheal tube size and probability of failed extubation. METHODS: We collected information pertaining to patients who underwent tracheotomy at 1 of 10 U.S. health care institutions between 2010 and 2019. Tracheostomy tube size was dichotomized (≥8 and <8). Multivariable logistic regression models were fit to identify predictors of (1) large tracheostomy tube size, and (2) decannulation before hospital discharge. RESULTS: The study included 5307 patients, including 2797 (52.7%) in the large tracheostomy cohort. Patient height (odds ratio [OR] = 1.060 per inch; 95% confidence interval [CI] 1.041-1.070) and obesity (1.37; 95% CI 1.1891.579) were associated with greater odds of large tracheostomy tube; otolaryngology performing the tracheotomy was associated with significantly lower odds of large tracheostomy tube (OR = 0.155; 95% CI 0.131-0.184). Large tracheostomy tube size (OR = 1.036; 95% CI 0.885-1.213) did not affect odds of decannulation. CONCLUSIONS: Obesity was linked with increased likelihood of large tracheostomy tube size, independent of patient height. Probability of decannulation before hospital discharge is influenced by multiple patient-centric factors, but not by size of tracheostomy tube.

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.

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.

Polyamine Metabolites as Biomarkers in Head and Neck Cancer Biofluids.

Background: Novel, non-invasive diagnostic biomarkers that facilitate early intervention in head and neck cancer are urgently needed. Polyamine metabolites have been observed to be elevated in numerous cancer types and correlated with poor prognosis. The aim of this study was to assess the concentration of polyamines in the saliva and urine from head and neck cancer (HNC) patients, compared to healthy controls. Methods: Targeted metabolomic analysis was performed on saliva and urine from 39 HNC patient samples and compared to 89 healthy controls using a quantitative, targeted liquid chromatography mass spectrometry approach. Results: The metabolites N1-acetylspermine (ASP), N8-acetylspermidine (ASD) and N1,N12-diacetylspermine (DAS) were detected at significantly different concentrations in the urine of HNC patients as compared to healthy controls. Only ASP was detected at elevated levels in HNC saliva as compared to healthy controls. Conclusion: These data suggest that assessment of polyamine-based metabolite biomarkers within the saliva and urine warrants further investigation as a potential diagnostic in HNC patients.

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.

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.

Association of Functional Outcomes in Tracheoesophageal Voicing With Intratracheal Pressures and Esophagram Findings.

Importance: Tracheoesophageal voice prosthesis (TEP) is a commonly used device for alaryngeal voicing following total laryngectomy. Variability in TEP voice and speech production may be reflected in differences in intratracheal pressures. Objective: To examine the association between intratracheal manometric pressure (IMP), speech function, and proximal esophageal abnormalities in patients with TEP. Design, Setting, and Participants: This retrospective cohort study was conducted at a single academic institution and included all patients with a history of total laryngectomy and TEP who completed a radiographic esophagram and intratracheal manometry between September 9, 2019, and December 4, 2019. Main Outcomes and Measures: Intratracheal manometric pressures during sustained phonation, conversational speech, and maximum loudness tasks were obtained for 22 patients. Pressure metrics, phonation duration time, and fluency of speech production were compared between patients with dysphagia with those without swallowing complaints. The association between pressure and speech metrics was also assessed. Results: Of 22 patients, 17 (77.2%) were men, 5 (22.7%) were women, and the mean (SD) age was 66.6 (8.8) years. The mean (SD) sustained phonation duration time was 9.3 (5.2) seconds, and the mean (SD) IMP during sustained phonation was 50.5 (21.4) cm H20. The IMPs during sustained phonation were strongly correlated with conversational speech (r = 0.712; 95% CI, 0.384-1.039) and moderately correlated with maximum loudness tasks (r = 0.524; 95% CI, 0.127-0.921). The IMPs during conversational speech were moderately correlated with maximum loudness task (r = 0.538; 95% CI, 0.145-0.931). Increased IMP during sustained phonation was moderately correlated with decreased sustained phonation duration time (r = -0.450; 95% CI, -0.867 to -0.034) and conversational speech was moderately correlated with decreased sustained phonation duration time (r = -0.524; 95% CI, -0.921 to -0.127). Patients with subjective swallowing complaints and proximal esophagus abnormalities had a shorter maximum phonation time (mean [SD], 7.08 [5.03] seconds) compared with patients without subjective dysphagic complaints (mean [SD], 11.95 [4.40] seconds), with a large effect size (Cohen d = 1.031; 95% CI, 0.141-1.92). All patients with nonfluent TEP speech production had structural abnormalities of the proximal esophagus. No difference in pressure or speech metrics was observed for primary closure vs reconstructive flap type. Conclusions and Relevance: This cohort study found that increased IMP and abnormalities of the proximal esophagus were associated with worse TEP speech quality. Evaluation of the esophagus should be considered in patients who are experiencing difficulties with TEP voicing. Further investigation of intratracheal manometry as a biofeedback tool to improve TEP voicing is needed.

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.

Moving Forward with Dysphagia Care: Implementing Strategies during the COVID-19 Pandemic and Beyond.

Growing numbers of SARS-CoV-2 cases coupled with limited understanding of transmissibility and virulence, have challenged the current workflow and clinical care pathways for the dysphagia provider. At the same time, the need for non-COVID-19-related dysphagia care persists. Increased awareness of asymptomatic virus carriers and variable expression of the disease have also focused attention to appropriate patient care in the context of protection for the healthcare workforce. The objective of this review was to create a clinical algorithm and reference for dysphagia clinicians across clinical settings to minimize spread of COVID-19 cases while providing optimal care to patients suffering from swallowing disorders. Every practitioner and healthcare system will likely have different constraints or preferences leading to the utilization of one technique over another. Knowledge about this pandemic increases every day, but the algorithms provided here will help in considering the best options for proceeding with safe and effective dysphagia care in this new era.

Reconstruction technique following total laryngectomy affects swallowing outcomes.

OBJECTIVES: How reconstruction affects function following total laryngectomy is unclear. This study seeks to determine whether reconstruction method is associated with differences in swallowing outcomes. METHODS: Retrospective review of reconstruction technique in patients undergoing TL was compared by pharyngeal transit time (PTT), patient-reported dysphagia (EAT-10), and diet-tolerated (FOIS). RESULTS: Ninety-five patients met inclusion criteria, with 40 patients (42.1%) undergoing primary closure and 55 patients (57.9%) undergoing tissue transfer. There was no difference in EAT-10 scores between the groups (P = .09). There was a significantly higher proportion of patients achieving oral diet (FOIS >3) with primary closure (P = .003). Patients undergoing PMC vs free flap had similar rates of g-tube dependency. Primary closure had the shortest PTT (1.89 seconds) compared to free flap (3.47-4.65 seconds) or PMC (5.1 seconds; P = .035). CONCLUSIONS: When primary closure is achievable, these results suggest improved swallowing outcomes with better tolerance of oral diet and shorter pharyngeal transit times. LEVEL OF EVIDENCE: IV.

Assessment of Tracheostomy and Laryngectomy Knowledge among Non-Otolaryngology Physicians.

OBJECTIVE: Identify knowledge deficits about alternate airways (AAs) (tracheostomy and laryngectomy) among physicians across multiple specialties a tertiary institution and to assess the impact of an educational lecture on improving deficits. METHODS: Study Design: Cross-sectional assessment. Setting: Academic medical center. Subjects and Methods: An anonymous 10-item, multiple choice assessment was given to physicians at a tertiary care center in the departments of Otolaryngology, Emergency Medicine, Family Medicine, General Surgery, Internal Medicine, and Pediatrics. An educational lecture on AAs was presented. Scores between a pre-lecture and a 3-month post-lecture assessment were compared. Data was analyzed using ANOVA and chi-squared analysis. RESULTS: Otolaryngology physicians scored an average of 97.8%, while non-otolaryngology physicians scored 58.3% (P < .05). Non-otolaryngology surgical physicians scored 68.4% while non-surgical physicians were lower at 55.1% (P < .0001). Comparing pre-lecture to post-lecture scores, all non-otolaryngology physicians improved their scores significantly from 58.3% to 86.5% (P < .005). Non-surgical physicians had significant improvement after the instructional lecture, closing the score gap with surgical physicians for the post-lecture assessment. DISCUSSION: The care of patients with AAs requires an understanding of their basic principles. Our findings identify significant knowledge deficits among non-otolaryngologists. Through an instructional lecture, we demonstrated improvement in knowledge among non-otolaryngology physicians and durability of the knowledge after 3 months. CONCLUSIONS: Through an instructional lecture, we found tracheostomy and laryngectomy knowledge deficits can be identified and improved upon. Periodic reinforcement of basic principles for non-otolaryngology physicians may be a promising strategy to ensure the proper care of patients with AAs.

Validation of the PILL-5: A 5-Item Patient Reported Outcome Measure for Pill Dysphagia.

Objectives: Pill dysphagia is common and costly with a significant risk of pill retention, caustic injury, and poor medication compliance. The purpose of this investigation was to determine the validity and reliability of the PILL-5, a self-administered patient reported outcome measure (PROM) to quantify the degree of pill (tablet and capsule) dysphagia. The PILL-5 is a 5-item questionnaire with a maximum symptom score of 20. Methods: The PILL-5 was administered to 190 patients with dysphagia referred for videofluoroscopic esophagography (VFE). Construct validity was assessed by comparing PILL-5 composite scores to delayed barium tablet transit on VFE. Normative data was obtained by administering the instrument to a cohort of healthy community based volunteers. Internal consistency was assessed with the Cronbach alpha. Test/retest reliability was determined by administering the instrument to the same cohort of patients at two time points. Results: The mean PILL-5 was 5.6 (±4.9) for persons with dysphagia and 1.6 (±2.7) for healthy volunteers (p < 0.001). The internal consistency of the instrument was high (Cronbach alpha = 0.85). The mean PILL-5 was 4.3 (±4.1) for patients with normal transit and 7.6 (±5.3) for patients with delayed barium tablet transit on esophagography, indicating excellent criterion based validity (p < 0.001). Reproducibility was high with an intraclass correlation coefficient of 0.83 (p < 0.001). Conclusions: Healthy individuals report some degree of swallowing difficulty with pills. Normative data suggest that a PILL-5 > 6 is abnormal (mean + 2 SD). The instrument demonstrated excellent criterion based validity and reliability. The PILL-5 is the first validated patient reported outcome measure for pill dysphagia.

Volitional control of the upper esophageal sphincter with high-resolution manometry driven biofeedback.

INTRODUCTION: Dysfunction of the upper esophageal sphincter (UES) is associated with swallow dysfunction and globus pharyngeus. Although volitional augmentation of the UES has been previously documented, the ability of individuals to control UES pressure with high-resolution manometry (HRM) driven biofeedback has not been assessed. PURPOSE: To evaluate the ability of patient driven HRM biofeedback to control UES basal pressure. METHODS: HRM data was collected from 10 patients undergoing esophageal manometry. Participants were trained on real-time HRM-driven biofeedback to both elevate and reduce UES pressure. Measures of baseline UES minimum, mean and maximum pressures (mmHg) were compared to biofeedback-driven volitional increases and decreases in UES pressures. Pre- and post-biofeedback data were compared with paired sample T-tests. RESULTS: The mean age (± standard deviation) of the cohort was 68 (±12.7) years. Sixty percent (6/10) were female. The mean UES baseline pressure increased from 30.1 (±15.3) mmHg to 44.8 (±25.03) mmHg (P = .02) with biofeedback-driven UES augmentation (P < .05). Maximum UES pressures were also increased from 63.84 (±24.1) mmHg to 152.4 (±123.7) (P = .04). Although some individuals were able to successfully decrease basal UES tone with the HRM biofeedback, no statistically significant group differences were observed (P > .05). CONCLUSION: Volitional control of UES pressure is possible with HRM-driven biofeedback. Patients vary in their ability to intentionally control UES pressure and some may require further training aimed at lowering UES pressure with HRM-guided biofeedback. These data may have significant implications for the future treatment of UES disorders and warrant further investigation. LEVEL OF EVIDENCE: 4.