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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

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

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

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

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

A scoping review of the methods used to capture dysphagia after anterior cervical discectomy and fusion: the need for a paradigm shift

Molfenter, Sonja M; Amin, Milan R; Balou, Matina; Herzberg, Erica G; Frempong-Boadu, Anthony
OBJECTIVE:Dysphagia is the most commonly reported complication of annterior cervical discectomy and fusion (ACDF) surgery. However, the incidence of dysphagia post-ACDF varies widely-partly attributable to differing outcome measures used to capture dysphagia. Our objective was to conduct a scoping review of the literature to quantify which dysphagia outcome measures have been employed post-ACDF and examine trends by study design, year, and location. METHODS:After removing duplicates, 2396 abstracts were screened for inclusion. A total of 480 studies were eligible for full-text review. After applying exclusion criteria, data was extracted from 280 studies. We extracted the dysphagia outcome measure(s), study design (prospective vs retrospective), year, and location (country). Approximately 10% of studies were repeated for intra-rater agreement. RESULTS:In total, 317 dysphagia outcome measures were reported in 280 studies (primarily retrospective-63%). The largest proportion of outcome measures were categorized as "unvalidated patient-reported outcome measures" (46%), largely driven by use of the popular Bazaz scale. The next most common categories were "insufficient detail" and "validated patient-reported outcome measures" (both 16%) followed by "chart review/database" (13%) and instrumental assessment (7%). Studies examining dysphagia post-ACDF steadily increased over the years and the use of validated measures increased in the past 10 years. CONCLUSIONS:This scoping review of the literature highlights that nearly half of the ACDF dysphagia literature relies on unvalidated patient-reported outcome measures. The current understanding of the mechanism, timeline, and presentation of dysphagia post-ACDF are likely limited due to the metrics that are most commonly reported in the literature.
PMID: 36625955
ISSN: 1432-0932
CID: 5410402

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

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 Impeluxâ„¢ 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: N/A Laryngoscope, 2023.
ISSN: 0023-852x
CID: 5549132

Prospective, Multi-Center Study of the Anatomic Distribution of Recurrent Respiratory Papillomatosis

Benedict, Peter A; Kravietz, Adam; Achlatis, Efstratios; Wang, Binhuan; Zhang, Yan; Kidane, Joseph; Harrison, Tina; Miller, Jonas; Drake, Virginia E; Best, Simon R; McWhorter, Andrew J; Lin, R Jun; Rosen, Clark A; Smith, Libby J; Amin, Milan R
OBJECTIVES/HYPOTHESIS/OBJECTIVE:To create a model of the anatomic distribution, recurrence, and growth patterns of recurrent respiratory papillomatosis (RRP). STUDY DESIGN/METHODS:Prospective, multi-institutional cohort study. METHODS:Adult patients with a diagnosis of RRP evaluated between August 1, 2018 and February 1, 2021 at six participating centers were invited to enroll. At each office or operating room encounter, laryngologists recorded the location and size of RRP lesions using a 22-region schematic. A generalized linear mixed effects model was used to compare region variations in lesion prevalence and recurrence. RESULTS:The cohort comprised 121 patients: 74% were male, 81% had been diagnosed with adult-onset RRP, and a plurality (34%) had undergone 0 to 3 RRP interventions prior to enrollment. Across the study period, the odds of a lesion occurring in the glottis was significantly higher (odds ratio [OR]: 26.51; 95% confidence interval [CI]: 11.76-59.75, P < .001) compared with all other areas of the larynx and trachea. Within the true vocal folds, the membranous vocal folds had significantly higher odds (OR: 6.16; 95% CI: 2.66-14.30, P < .001) of lesion occurrence compared to the cartilaginous vocal folds. Despite these strong trends in lesion distribution, there were no differences in the odds of lesion recurrence, growth, or in the time to recurrence, between anatomic subsites. CONCLUSIONS:RRP lesions are most likely to occur in the glottis, particularly the membranous vocal folds, compared with other regions of the larynx or trachea. However, all lesions demonstrate similar behavior with respect to recurrence, growth, and time to recurrence regardless of anatomic location. LEVEL OF EVIDENCE/METHODS:3 Laryngoscope, 2022.
PMID: 35129220
ISSN: 1531-4995
CID: 5167092

A Novel Approach to Vocal Fold Mucous Retention Cysts: Awake KTP Laser-Assisted Marsupialization

Gao, William Z; Abu-Ghanem, Sara; Reder, Lindsay S; Amin, Milan; Johns, Michael M
Vocal fold mucous retention cysts are an important etiology of dysphonia and have classically been treated via microsurgical excision under general anesthesia. We present four cases that were treated with a novel technique of awake potassium-titanyl-phosphate laser-assisted marsupialization under local anesthesia. Reasons for in-office treatment included older age, medical comorbidities, and desire to avoid surgery/general anesthesia. No recurrences were observed and all patients had improved vocal quality, with a mean reduction in Voice Handicap Index-10 of 12.5. Hence, awake potassium-titanyl-phosphate laser treatment exhibits potential as a modality for addressing vocal fold mucous retention cysts in select patients with favorable outcomes.
PMID: 32843259
ISSN: 1873-4588
CID: 4595932