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

Lechien, Jerome R; Vaezi, Michael F; Chan, Walter W; Allen, Jacqueline E; Karkos, Petros D; Saussez, Sven; Altman, Kenneth W; Amin, Milan R; Ayad, Tareck; Barillari, Maria R; Belafsky, Peter C; Blumin, Joel H; Johnston, Nikki; Bobin, Francois; Broadhurst, Matthew; Ceccon, Fabio P; Calvo-Henriquez, Christian; Eun, Young-Gyu; Chiesa-Estomba, Carlos M; Crevier-Buchman, Lise; Clarke, John O; Dapri, Giovanni; Eckley, Claudia A; Finck, Camille; Fisichella, P Marco; Hamdan, Abdul-Latif; Hans, Stephane; Huet, Kathy; Imamura, Rui; Jobe, Blair A; Hoppo, Toshitaka; Maron, Lance P; Muls, Vinciane; O'Rourke, Ashli K; Perazzo, Paulo S; Postma, Gregory; Prasad, Vyas M N; Remacle, Marc; Sant'Anna, Geraldo D; Sataloff, Robert T; Savarino, Edoardo V; Schindler, Antonio; Siupsinskiene, Nora; Tseng, Ping-Huei; Zalvan, Craig H; Zelenik, Karol; Fraysse, Bernard; Bock, Jonathan M; Akst, Lee M; Carroll, Thomas L
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/CONCLUSIONS: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/METHODS:5 Laryngoscope, 134:1614-1624, 2024.
PMID: 37929860
ISSN: 1531-4995
CID: 5639632

Vocal Health Assessment of Professional Performers Returning to the Stage After the COVID-19 Pandemic Shutdown

Crosby, Tyler; Ezeh, Uche C; Achlatis, Stratos; Kwak, Paul E; Amin, Milan R; Johnson, Aaron M
OBJECTIVES/HYPOTHESIS/OBJECTIVE:This study assessed the vocal health of performers returning to full-time performance after the COVID-19 pandemic shutdown and investigated how differences in voice usage, exposure to voice care professionals, and vocal pathology before and during the pandemic contributed to variability in self-perceived and instrumental vocal outcome measures. STUDY DESIGN/METHODS:This was a prospective, case-control observational study conducted at a single outpatient site. METHODS:Twenty-two patients, 11 cases and 11 controls, were enrolled for the study. All participants were full-time singing professionals prior to the COVID-19 pandemic. Cases were recruited from patients presenting to a tertiary care voice center for vocal or pharyngeal complaints. Controls were healthy volunteers recruited from the general population of professional singers in the surrounding metropolitan area. All participants provided responses to the Voice Handicap Index-10, Evaluation of Ability to Sing Easily, and Laryngopharyngeal Measure of Perceived Sensation validated questionnaires as well as a study survey with questions regarding vocal use and history prior to and during the pandemic. All participants underwent instrumental acoustic and videostroboscopic voice evaluations. RESULTS:Cases had poorer outcome measures overall and were more likely to report their voices were worse at study enrollment when compared to their prepandemic perception (P = 0.027). Cases tended to be older and less likely to have pursued alternative employment during the pandemic that involved increased speaking voice use (27% vs 55%), but these differences were not statistically significant. CONCLUSIONS:There was a variable response among performers to the prolonged hiatus from performing during the COVID-19 pandemic. Those with poorer outcomes tended to be older and may have used their voice less during the pandemic. These findings are consistent with detraining periods in the exercise physiology literature and support the construct of treating vocal performers as vocal athletes.
PMID: 38296764
ISSN: 1873-4588
CID: 5627182

A Large Cohort Analysis of Epiglottic Phenotypes and Pharyngeal Residue

Kravietz, Adam; Crosby, Tyler; Yang, Jackie; Balou, Stamatela; Dion, Gregory R.; Logan, Ashley; Amin, Milan R.
Objective: To describe the phenotypic characteristics of the epiglottis at rest and their impact on vallecular residue. Methods: Videofluoroscopic studies (VFSS) were pooled from 2 Laryngology practices, and Image J was used to measure epiglottic anatomic features at rest. Studies were rated by the MBSImp and presence of vallecular residue following swallow of thin and puree boluses. A conditional inference tree analysis was performed to isolate which epiglottic parameters were risk factors for presence of vallecular reside followed by logistic regression. Results: The majority of patients had a normal shaped epiglottis, followed by omega shape. The mean angle of the epiglottis from the hyoid was approximately 90°. Only abnormal epiglottic movement was associated with increased risk of residue for thin boluses (OR 35.09, CI 10.93-158.66, P <.001). However, in those with normal epiglottic movement, age >70 years old was associated with increased risk of residue (OR 3.98, CI 1.73-9.23, P =.001). For puree boluses, a normal or omega shaped epiglottis was associated with residue (OR 5.19, CI 2.41-11.51, P <.001), and this relationship was further modulated by increased distance of the epiglottic tip from the posterior pharyngeal wall. No other anatomic features of the resting epiglottis were associated with residue. Comorbidities potentially affecting swallow were infrequent in the cohort and were not associated with residue. Conclusion: Abnormal epiglottic movement is associated with aspiration, and in this study we find that abnormal epiglottic movement increases the risk of vallecular residue and that older age is a risk factor for residue. The resting properties of the epiglottis do not appear to be associated with abnormal epiglottic movement or residue.
SCOPUS:85181689250
ISSN: 0003-4894
CID: 5630122

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

Howell, Rebecca; Johnson, Christopher; Allen, Jacqui; Altaye, Mekibib; Amin, Milan; Bayan, Semirra; Belafsky, Peter; Cervenka, Brian; Desilva, Brad; Dion, Gregory R; Ekbom, Dale; Friedman, Aaron; Fritz, Mark; Giliberto, John Paul; Guardiani, Elizabeth; Kasperbauer, Jan; Kim, Brandon; Krekeler, Brittany N; Kuhn, Maggie; Kwak, Paul; Ma, Yue; Madden, Lyndsay L; Matrka, Laura; Mayerhoff, Ross; McKeon, Mallory; Piraka, Cyrus; Rosen, Clark A; Tabangin, Meredith; Wahab, Shaun A; Wilson, Keith; Wright, Carter; Young, VyVy N; Postma, Gregory
OBJECTIVE:To compare improvement in patient-reported outcomes (PROM) in persons undergoing endoscopic and open surgical management of Zenker diverticula (ZD). METHODOLOGY/METHODS: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/CONCLUSIONS: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/METHODS:Level 3 Laryngoscope, 2023.
PMID: 37191092
ISSN: 1531-4995
CID: 5503502

Validation of a 3D-Printed Percutaneous Injection Laryngoplasty Simulator: A Randomized Controlled Trial

Kostas, Julianna C; Lee, Andrew S; Arunkumar, Amit; Han, Catherine; Lee, Mark; Goel, Alexander N; Alrassi, James; Crosby, Tyler; Clark, Christine M; Amin, Milan; Abu-Ghanem, Sara; Kirke, Diana; Rameau, Anaïs
OBJECTIVE:Simulation may be a valuable tool in training laryngology office procedures on unsedated patients. However, no studies have examined whether existing awake procedure simulators improve trainee performance in laryngology. Our objective was to evaluate the transfer validity of a previously published 3D-printed laryngeal simulator in improving percutaneous injection laryngoplasty (PIL) competency compared with conventional educational materials with a single-blinded randomized controlled trial. METHODS:Otolaryngology residents with fewer than 10 PIL procedures in their case logs were recruited. A pretraining survey was administered to participants to evaluate baseline procedure-specific knowledge and confidence. The participants underwent block randomization by postgraduate year to receive conventional educational materials either with or without additional training with a 3D-printed laryngeal simulator. Participants performed PIL on an anatomically distinct laryngeal model via trans-thyrohyoid and trans-cricothyroid approaches. Endoscopic and external performance recordings were de-identified and evaluated by two blinded laryngologists using an objective structured assessment of technical skill scale and PIL-specific checklist. RESULTS:Twenty residents completed testing. Baseline characteristics demonstrate no significant differences in confidence level or PIL experience between groups. Senior residents receiving simulator training had significantly better respect for tissue during the trans-thyrohyoid approach compared with control (p < 0.0005). There were no significant differences in performance for junior residents. CONCLUSIONS:In this first transfer validity study of a simulator for office awake procedure in laryngology, we found that a previously described low-cost, high-fidelity 3D-printed PIL simulator improved performance of PIL amongst senior otolaryngology residents, suggesting this accessible model may be a valuable educational adjunct for advanced trainees to practice PIL. LEVEL OF EVIDENCE/METHODS:N/A Laryngoscope, 2023.
PMID: 37466294
ISSN: 1531-4995
CID: 5535732

The Effectiveness of Ultraviolet Smart D60 in Reducing Contamination of Flexible Fiberoptic Laryngoscopes

Ezeh, Uche C; Achlatis, Efstratios; Crosby, Tyler; Kwak, Paul E; Phillips, Michael S; Amin, Milan R
OBJECTIVE:To compare the effectiveness of disinfection protocols utilizing a ultraviolet (UV) Smart D60 light system with Impelux™ technology with a standard Cidex ortho-phthalaldehyde (OPA) disinfection protocol for cleaning flexible fiberoptic laryngoscopes (FFLs). METHODS:Two hundred FFLs were tested for bacterial contamination after routine use, and another 200 FFLs were tested after disinfection with one of four methods: enzymatic detergent plus Cidex OPA (standard), enzymatic detergent plus UV Smart D60, microfiber cloth plus UV Smart D60, and nonsterile wipe plus UV Smart D60. Pre- and post-disinfection microbial burden levels and positive culture rates were compared using Kruskal-Wallis ANOVA and Fisher's two-sided exact, respectively. RESULTS:After routine use, approximately 56% (112/200) of FFLs were contaminated, with an average contamination level of 9,973.7 ± 70,136.3 CFU/mL. The standard reprocessing method showed no positive cultures. The enzymatic plus UV, microfiber plus UV, and nonsterile wipe plus UV methods yielded contamination rates of 4% (2/50), 6% (3/50), and 12% (6/50), respectively, with no significant differences among the treatment groups (p > 0.05). The pre-disinfection microbial burden levels decreased significantly after each disinfection technique (p < 0.001). The average microbial burden recovered after enzymatic plus UV, microfiber plus UV, and nonsterile wipe plus UV were 0.40 CFU/mL ± 2, 0.60 CFU/mL ± 2.4, and 12.2 CFU/mL ± 69.5, respectively, with no significant difference among the treatment groups (p > 0.05). Micrococcus species (53.8%) were most frequently isolated, and no high-concern organisms were recovered. CONCLUSION:Disinfection protocols utilizing UV Smart D60 were as effective as the standard chemical disinfection protocol using Cidex OPA. LEVEL OF EVIDENCE:NA Laryngoscope, 133:3512-3519, 2023.
PMID: 37485725
ISSN: 1531-4995
CID: 5609162

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

Mau, Ted; Amin, Milan R; Belafsky, Peter C; Best, Simon R; Friedman, Aaron D; Klein, Adam M; Lott, David G; Paniello, Randal C; Pransky, Seth M; Saba, Nabil F; Howard, Tamara; Dallas, Michael; Patel, Aditya; Morrow, Matthew P; Skolnik, Jeffrey M
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/CONCLUSIONS: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/METHODS:3 Laryngoscope, 2023.
PMID: 37204106
ISSN: 1531-4995
CID: 5503642

Paralysis Versus Non-Paralysis Anesthesia for Operative Laryngoscopy: A Randomized Controlled Trial

Yang, Jackie; Crosby, Tyler; Chen, Sophia; Ezeh, Uche C; Patil, Sachi; Kwak, Paul E; Chin, Wanda A; Amin, Milan R
OBJECTIVE:To compare outcomes between two standard-of-care anesthesia regimens for operative laryngoscopy: general anesthesia with a neuromuscular blocking agent (NMBA) versus remifentanil and propofol (non-NMBA). METHODS:This was a prospective, single-blinded, randomized controlled trial at a tertiary care center. Patients were randomized to either anesthesia using rocuronium (NMBA) or with remifentanil/propofol infusion alone (non-NMBA). Intraoperative impressions, anesthesia data, and post-operative patient surveys were collected. RESULTS:Sixty-one patients who underwent suspension laryngoscopy from 2020 to 2022 were included (25 female, 36 male, ranging 20-81 years). Thirty patients were enrolled in the NMBA arm and 31 patients in the non-NMBA arm. Heart rate and mean arterial pressure were higher in the NMBA (p < 0.01). Patients in the non-NMBA group were more likely to require vasopressors (p = 0.04, RR = 3.08 [0.86-11.05]). Surgeons were more frequently satisfied with conditions in the NMBA group (86.7%) compared to the non-NMBA group (58.1%, p < 0.01). Procedures were more likely to be paused due to movement in the non-NMBA group (45.1%) compared to the NMBA group (16.6%, p < 0.03, RR = 2.26 [1.02-4.99]). Patients in the non-NMBA group were more likely to endorse myalgia the week after surgery (44%) compared to the NMBA group (8.3%, p < 0.01) and reported higher average pain levels on a 0-10 pain scale (3.7) compared to the paralysis group (2.0). CONCLUSIONS:Anesthesia with rocuronium was associated with better intraoperative conditions and postoperative pain compared to anesthesia with remifentanil/propofol. Remifentanil/propofol were associated with lower blood pressure and suppression of laryngoscopy-associated tachycardia. LEVEL OF EVIDENCE/METHODS:Level 2 Laryngoscope, 2023.
PMID: 36715102
ISSN: 1531-4995
CID: 5419902

Longitudinal Effects of Base of Tongue Concurrent Chemoradiation Therapy in a Pre-Clinical Model

Benedict, Peter A; Kravietz, Adam; Yang, Jackie; Achlatis, Efstratios; Doyle, Carina; Johnson, Aaron M; Dion, Gregory R; Amin, Milan R
BACKGROUND/OBJECTIVES/OBJECTIVE:Base of tongue (BOT) dysfunction is common following oropharyngeal concurrent chemoradiation therapy (CCRT). We present a clinically relevant animal model quantifying the effects of CCRT on tongue strength and elasticity over time. METHODS:Fifty-three male and 53 female Sprague-Dawley rats were randomized to control or experimental groups. Experimental animals received cisplatin, 5-fluorouracil, and 5 fractions of 7 Gy directed to the BOT. Controls received no intervention. At 2 weeks, 5 months, or 10 months after CCRT, animals underwent non-survival surgery to measure twitch and tetanic tongue strength, which were analyzed using multivariate linear mixed effects models. Tongue displacement, a surrogate for tongue elasticity, was also determined via stress-strain testing and analyzed via a multivariate linear mixed effects model. RESULTS:Reporting the combined results of both sexes, the estimated experimental group mean peak twitch forces became more divergent over time compared to controls, being 8.3% lower than controls at 2 weeks post-CCRT, 15.7% lower at 5 months, and 31.6% lower at 10 months. Estimated experimental group mean peak tetanic forces followed a similar course and were 2.9% lower than controls at 2 weeks post CCRT, 20.7% lower at 5 months, and 27.0% lower at 10 months. Stress-strain testing did not find CCRT to have a significant effect on tongue displacement across experimental timepoints. CONCLUSIONS:This study demonstrates an increasing difference in tongue strength over time between controls and animals exposed to CCRT. Tongue elasticity was not significantly affected by CCRT, suggesting that changes in strength may not be caused by fibrosis. LEVEL OF EVIDENCE/METHODS:NA Laryngoscope, 2022.
PMID: 36134872
ISSN: 1531-4995
CID: 5335542

Presumptive Diagnosis in Tele-Health Laryngology: A Multi-Center Observational Study

Montalbaron, Michael B; Achlatis, Efstratios; Johnson, Aaron M; Ma, Yue; Young, VyVy N; Rosen, Clark A; Amin, Milan R; Kwak, Paul E
OBJECTIVES/UNASSIGNED:Early in the COVID-19 pandemic, outpatient visits were adapted for the virtual setting, forcing laryngologists to presume certain diagnoses without the aid of laryngoscopy, solely based on history and the limited physical exam available via video visit. This study aims to examine the accuracy of presumptive diagnoses made via telemedicine, compared to subsequent in-person follow up, where endoscopic examination could confirm or refute suspected diagnoses. METHODS/UNASSIGNED:A retrospective chart review was conducted of 38 patients evaluated for voice-related issues at NYU Langone Health and the University of California-San Francisco. Presumptive diagnoses at the initial telemedicine encounter were noted, along with diagnostic cues used for clinical reasoning and recommended treatment plans. These presumptive diagnoses were compared to diagnoses and plans established following laryngoscopy at follow-up in-person visits. RESULTS/UNASSIGNED:After laryngoscopy at the first in-person visit, 38% of presumptive diagnoses changed, as did 37% of treatment plans. The accuracy varied among conditions. Muscle tension dysphonia and Reinke's edema were accurately diagnosed without laryngoscopy, but other conditions, including vocal fold paralysis and subglottic stenosis, were not initially suspected, relying on laryngoscopy for diagnosis. CONCLUSIONS/UNASSIGNED:While some laryngologic conditions may be reasonably identified without in-person examination, laryngoscopy remains central to definitive diagnosis and treatment. Telemedicine can increase access to care, but it may provide more utility as a screening tool, triaging which patients should present more urgently for in-person laryngoscopy. LEVEL OF EVIDENCE/UNASSIGNED:4.
PMID: 37070580
ISSN: 1943-572x
CID: 5464412