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Percutaneous Dilational Tracheostomy for Coronavirus Disease 2019 Patients Requiring Mechanical Ventilation
Angel, Luis F; Amoroso, Nancy E; Rafeq, Samaan; Mitzman, Brian; Goldenberg, Ronald; Shekar, Saketh Palasamudram; Troxel, Andrea B; Zhang, Yan; Chang, Stephanie H; Kwak, Paul; Amin, Milan R; Sureau, Kimberly; Nafday, Heidi B; Thomas, Sarun; Kon, Zachary; Sommer, Philip M; Segal, Leopoldo N; Moore, William H; Cerfolio, Robert
OBJECTIVES/OBJECTIVE:To assess the impact of percutaneous dilational tracheostomy in coronavirus disease 2019 patients requiring mechanical ventilation and the risk for healthcare providers. DESIGN/METHODS:Prospective cohort study; patients were enrolled between March 11, and April 29, 2020. The date of final follow-up was July 30, 2020. We used a propensity score matching approach to compare outcomes. Study outcomes were formulated before data collection and analysis. SETTING/METHODS:Critical care units at two large metropolitan hospitals in New York City. PATIENTS/METHODS:Five-hundred forty-one patients with confirmed severe coronavirus disease 2019 respiratory failure requiring mechanical ventilation. INTERVENTIONS/METHODS:Bedside percutaneous dilational tracheostomy with modified visualization and ventilation. MEASUREMENTS AND MAIN RESULTS/RESULTS:Required time for discontinuation off mechanical ventilation, total length of hospitalization, and overall patient survival. Of the 541 patients, 394 patients were eligible for a tracheostomy. One-hundred sixteen were early percutaneous dilational tracheostomies with median time of 9 days after initiation of mechanical ventilation (interquartile range, 7-12 d), whereas 89 were late percutaneous dilational tracheostomies with a median time of 19 days after initiation of mechanical ventilation (interquartile range, 16-24 d). Compared with patients with no tracheostomy, patients with an early percutaneous dilational tracheostomy had a higher probability of discontinuation from mechanical ventilation (absolute difference, 30%; p < 0.001; hazard ratio for successful discontinuation, 2.8; 95% CI, 1.34-5.84; p = 0.006) and a lower mortality (absolute difference, 34%, p < 0.001; hazard ratio for death, 0.11; 95% CI, 0.06-0.22; p < 0.001). Compared with patients with late percutaneous dilational tracheostomy, patients with early percutaneous dilational tracheostomy had higher discontinuation rates from mechanical ventilation (absolute difference 7%; p < 0.35; hazard ratio for successful discontinuation, 1.53; 95% CI, 1.01-2.3; p = 0.04) and had a shorter median duration of mechanical ventilation in survivors (absolute difference, -15 d; p < 0.001). None of the healthcare providers who performed all the percutaneous dilational tracheostomies procedures had clinical symptoms or any positive laboratory test for severe acute respiratory syndrome coronavirus 2 infection. CONCLUSIONS:In coronavirus disease 2019 patients on mechanical ventilation, an early modified percutaneous dilational tracheostomy was safe for patients and healthcare providers and associated with improved clinical outcomes.
PMID: 33826583
ISSN: 1530-0293
CID: 4839312
Shared Decision-making and Stakeholder Engagement in COVID-19 Tracheostomy-Reply
Kwak, Paul E; Persky, Michael J; Amin, Milan R
PMID: 33764364
ISSN: 2168-619x
CID: 4875412
Disparities in Mortality from Larynx Cancer: Implications for Reducing Racial Differences
Chen, Sophia; Dee, Edward Christopher; Muralidhar, Vinayak; Nguyen, Paul L; Amin, Milan R; Givi, Babak
OBJECTIVE:Race predicts overall mortality (OM) of laryngeal squamous cell carcinoma (LSCC) in the United States (US). We assessed whether racial disparities affect cancer-specific mortality (CSM) using the Surveillance, Epidemiology, and End Results (SEER) database. METHODS:Adults with LSCC from 2004 to 2015 were selected. Univariable and multivariable Cox proportional hazards and Fine-Gray competing-risks regression analysis adjusted for clinicodemographic factors defined hazard ratios (aHR). RESULTS:We identified 14,506 patients. The median age was 63 years. Most were male (11,725, 80.8%) and white (11,653, 80.3%), followed by Black (2294, 15.8%). Most had early-stage disease (7544, 52.0%) and received radiotherapy only (4107, 28.3%), followed by chemoradiation (3748, 25.8%). With median follow-up of 60 months, overall 3- and 5-year OM were 34.0% and 43.2%; CSM were 16.0% and 18.9%, respectively. Black patients had higher OM than white patients on univariable (HR 1.35, 95% CI, 1.26-1.44, P < .001) and multivariable (aHR 1.10, 95% CI, 1.02-1.18, P = .011) analyses. Black patients had higher CSM on univariable analysis (HR 1.22, 95% CI, 1.09-1.35, P < .001) but not on multivariable CSM analysis (aHR 1.01, 95% CI, 0.90-1.13, P = .864). On multivariable analysis, year of diagnosis, age, disease site, stage, treatment, nodal metastasis, marital status, education, and geography significantly predicted CSM. CONCLUSION/CONCLUSIONS:On multivariable analyses controlling for sociodemographic, clinical, and treatment characteristics, Black and white patients differed in OM but not in CSM. However, Black patients presented with greater proportions of higher stage cancers and sociodemographic factors such as income and marital status that were associated with worse outcomes. Efforts to target sociodemographic disparities may contribute to the mitigation of racial disparities in LSCC. LEVEL OF EVIDENCE/METHODS:4 Laryngoscope, 2020.
PMID: 32869893
ISSN: 1531-4995
CID: 4583052
Early Outcomes From Early Tracheostomy for Patients With COVID-19
Kwak, Paul E; Connors, Joseph R; Benedict, Peter A; Timen, Micah R; Wang, Binhuan; Zhang, Yan; Youlios, Stephanie; Sureau, Kimberly; Persky, Michael J; Rafeq, Samaan; Angel, Luis; Amin, Milan R
Importance/UNASSIGNED:Decision-making in the timing of tracheostomy in patients with coronavirus disease 2019 (COVID-19) has centered on the intersection of long-standing debates on the benefits of early vs late tracheostomy, assumptions about timelines of infectivity of the novel coronavirus, and concern over risk to surgeons performing tracheostomy. Multiple consensus guidelines recommend avoiding or delaying tracheostomy, without evidence to indicate anticipated improvement in outcomes as a result. Objective/UNASSIGNED:To assess outcomes from early tracheostomy in the airway management of patients with COVID-19 requiring mechanical ventilation. Design, Setting, and Participants/UNASSIGNED:A retrospective medical record review was completed of 148 patients with reverse transcriptase-polymerase chain reaction-confirmed COVID-19 requiring mechanical ventilation at a single tertiary-care medical center in New York City from March 1 to May 7, 2020. Interventions/UNASSIGNED:Open or percutaneous tracheostomy. Main Outcomes and Measures/UNASSIGNED:The primary outcomes were time from symptom onset to (1) endotracheal intubation, (2) tracheostomy; time from endotracheal intubation to tracheostomy; time from tracheostomy to (1) tracheostomy tube downsizing, (2) decannulation; total time on mechanical ventilation; and total length of stay. Results/UNASSIGNED:Participants included 148 patients, 120 men and 28 women, with an overall mean (SD) age of 58.1 (15.8) years. Mean (SD; median) time from symptom onset to intubation was 10.57 (6.58; 9) days; from symptom onset to tracheostomy, 22.76 (8.84; 21) days; and from endotracheal intubation to tracheostomy, 12.23 (6.82; 12) days. The mean (SD; median) time to discontinuation of mechanical ventilation was 33.49 (18.82; 27) days; from tracheostomy to first downsize, 23.02 (13.76; 19) days; and from tracheostomy to decannulation, 30.16 (16.00; 26) days. The mean (SD; median) length of stay for all patients was 51.29 (23.66; 45) days. Timing of tracheostomy was significantly associated with length of stay: median length of stay was 40 days in those who underwent early tracheostomy (within 10 days of endotracheal intubation) and 49 days in those who underwent late tracheostomy (median difference, -8; 95% CI, -15 to -1). In a competing risks model with death as the competing risk, the late tracheostomy group was 16% less likely to discontinue mechanical ventilation (hazard ratio, 0.84; 95% CI, 0.55 to 1.28). Conclusions and Relevance/UNASSIGNED:This cohort study from the first 2 months of the pandemic in New York City provides an opportunity to reconsider guidelines for tracheostomy for patients with COVID-19. Findings demonstrated noninferiority of early tracheostomy and challenges recommendations to categorically delay or avoid tracheostomy in this patient population. When aligned with emerging evidence about the timeline of infectivity of the novel coronavirus, this approach may optimize outcomes from tracheostomy while keeping clinicians safe.
PMID: 33331855
ISSN: 2168-619x
CID: 4718022
Association of Social Determinants of Health with Time to Diagnosis and Treatment Outcomes in Idiopathic Subglottic Stenosis
Lee, Jaclyn; Huang, Li-Ching; Berry, Lynn D; Anderson, Catherine; Amin, Milan R; Benninger, Michael S; Blumin, Joel H; Bock, Jonathan M; Bryson, Paul C; Castellanos, Paul F; Chen, Sheau-Chiann; Clary, Matthew S; Cohen, Seth M; Crawley, Brianna K; Dailey, Seth H; Daniero, James J; de Alarcon, Alessandro; Donovan, Donald T; Edell, Eric S; Ekbom, Dale C; Fink, Daniel S; Franco, Ramon A; Garrett, C Gaelyn; Guardiani, Elizabeth A; Hillel, Alexander T; Hoffman, Henry T; Hogikyan, Norman D; Howell, Rebecca J; Hussain, Lena K; Johns, Michael M; Kasperbauer, Jan L; Khosla, Sid M; Kinnard, Cheryl; Kupfer, Robbi A; Langerman, Alexander J; Lentz, Robert J; Lorenz, Robert R; Lott, David G; Lowery, Anne S; Makani, Samir S; Maldonado, Fabien; Mannion, Kyle; Matrka, Laura; McWhorter, Andrew J; Merati, Albert L; Mori, Matthew; Netterville, James L; O'Dell, Karla; Ongkasuwan, Julina; Postma, Gregory N; Reder, Lindsay S; Rohde, Sarah L; Richardson, Brent E; Rickman, Otis B; Rosen, Clark A; Rutter, Michael J; Sandhu, Guri S; Schindler, Joshua S; Schneider, G Todd; Shah, Rupali N; Sikora, Andrew G; Sinard, Robert J; Smith, Marshall E; Smith, Libby J; Soliman, Ahmed M S; Sveinsdóttir, SigrÃður; Van Daele, Douglas J; Veivers, David; Verma, Sunil P; Weinberger, Paul M; Weissbrod, Philip A; Wootten, Christopher T; Shyr, Yu; Francis, David O; Gelbard, Alexander
OBJECTIVES/UNASSIGNED:To examine whether social determinants of health (SDH) factors are associated with time to diagnosis, treatment selection, and time to recurrent surgical intervention in idiopathic subglottic stenosis (iSGS) patients. METHODS/UNASSIGNED:Adult patients with diagnosed iSGS were recruited prospectively (2015-2017) via clinical providers as part of the North American Airway Collaborative (NoAAC) and via an online iSGS support community on Facebook. Patient-specific SDH factors included highest educational attainment (self-reported), median household income (matched from home zip code via U.S. Census data), and number of close friends (self-reported) as a measure of social support. Main outcomes of interest were time to disease diagnosis (years from symptom onset), treatment selection (endoscopic dilation [ED] vs cricotracheal resection [CTR] vs endoscopic resection with adjuvant medical therapy [ERMT]), and time to recurrent surgical intervention (number of days from initial surgical procedure) as a surrogate for disease recurrence. RESULTS/UNASSIGNED:The total 810 participants were 98.5% female, 97.2% Caucasian, and had a median age of 50 years (IQR, 43-58). The cohort had a median household income of $62 307 (IQR, $50 345-$79 773), a median of 7 close friends (IQR, 4-10), and 64.7% of patients completed college or graduate school. Education, income, and number of friends were not associated with time to diagnosis via multivariable linear regression modeling. Univariable multinominal logistic regression demonstrated an association between education and income for selecting ED versus ERMT, but no associations were noted for CTR. No associations were noted for time to recurrent surgical procedure via Kaplan Meier modeling and Cox proportional hazards regression. CONCLUSIONS/UNASSIGNED:Patient education, income, and social support were not associated with time to diagnosis or time to disease recurrence. This suggests additional patient, procedure, or disease-specific factors contribute to the observed variations in iSGS surgical outcomes.
PMID: 33629608
ISSN: 1943-572x
CID: 4875162
Long-term intubation and high rate of tracheostomy in COVID-19 patients might determine an unprecedented increase of airway stenoses: a call to action from the European Laryngological Society
Piazza, Cesare; Filauro, Marta; Dikkers, Frederik G; Nouraei, S A Reza; Sandu, Kishore; Sittel, Christian; Amin, Milan R; Campos, Guillermo; Eckel, Hans E; Peretti, Giorgio
INTRODUCTION/BACKGROUND:The novel Coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2, may need intensive care unit (ICU) admission in up to 12% of all positive cases for massive interstitial pneumonia, with possible long-term endotracheal intubation for mechanical ventilation and subsequent tracheostomy. The most common airway-related complications of such ICU maneuvers are laryngotracheal granulomas, webs, stenosis, malacia and, less commonly, tracheal necrosis with tracheo-esophageal or tracheo-arterial fistulae. MATERIALS AND METHODS/METHODS:This paper gathers the opinions of experts of the Laryngotracheal Stenosis Committee of the European Laryngological Society, with the aim of alerting the medical community about the possible rise in number of COVID-19-related laryngotracheal stenosis (LTS), and the aspiration of paving the way to a more rationale concentration of these cases within referral specialist airway centers. RESULTS:A range of prevention strategies, diagnostic work-up, and therapeutic approaches are reported and framed within the COVID-19 pandemic context. CONCLUSIONS:One of the most important roles of otolaryngologists when encountering airway-related signs and symptoms in patients with previous ICU hospitalization for COVID-19 is to maintain a high level of suspicion for LTS development, and share it with colleagues and other health care professionals. Such a condition requires specific expertise and should be comprehensively managed in tertiary referral centers.
PMCID:7275663
PMID: 32506145
ISSN: 1434-4726
CID: 4510402
Autologous fibroblasts for vocal scars and age-related atrophy: A randomized clinical trial
Ma, Yue; Long, Jennifer; Amin, Milan R; Branski, Ryan C; Damrose, Edward J; Sung, Chih-Kwang; Achlatis, Stratos; Kearney, Ann; Chhetri, Dinesh K
OBJECTIVES/HYPOTHESIS/OBJECTIVE:To assess the safety and efficacy of autologous cultured fibroblasts (ACFs) to treat dysphonia related to vocal fold scar and age-related vocal atrophy (ARVA). STUDY DESIGN/METHODS:Randomized, double-blinded, placebo-controlled, multi-institutional, phase II trial. METHODS:cells or placebo saline was performed at 4-week intervals for each vocal fold. Follow-up was performed at 4, 8, and 12 months. The primary outcome was improved mucosal waves. Secondary outcomes included Voice Handicap Index (VHI)-30, patient reported voice quality outcomes, and perceptual analysis of voice. RESULTS:Fifteen subjects received ACF and six received saline injections. At 4, 8, and 12 months after ACF treatments, a significant improvement in mucosal wave grade relative to baseline was observed in both vocal scar and ARVA groups. Relative to control group, mucosal waves were significantly improved in the ARVA group at 4 and 8 months. Perceptual analysis significantly improved in the vocal scar group 12 months after ACF treatments compared to controls. Vocal scar group reported significantly improved vocal quality from baseline. VHI and expert rater voice grade improved in both groups, but did not achieve significance. No adverse events related to fibroblast injections were observed. CONCLUSIONS:In this cohort, injection of ACFs into the vocal fold lamina propria (LP) was safe and significantly improved mucosal waves in patients with vocal scar and ARVA. ACF may hold promise to reconstruct the LP. LEVEL OF EVIDENCE/METHODS:1 Laryngoscope, 2019.
PMID: 31804729
ISSN: 1531-4995
CID: 4218812
Characterization of Persistent Uncontrolled Asthma Symptoms in Community Members Exposed to World Trade Center Dust and Fumes
Reibman, Joan; Caplan-Shaw, Caralee; Wu, Yinxiang; Liu, Mengling; Amin, Milan R; Berger, Kenneth I; Cotrina-Vidal, Maria L; Kazeros, Angeliki; Durmus, Nedim; Fernandez-Beros, Maria-Elena; Goldring, Roberta M; Rosen, Rebecca; Shao, Yongzhao
The destruction of the World Trade Center (WTC) towers on the 11th of September, 2001 released a vast amount of aerosolized dust and smoke resulting in acute and chronic exposures to community members as well as responders. The WTC Environmental Health Center (WTC EHC) is a surveillance and treatment program for a diverse population of community members, including local residents and local workers with WTC dust exposure. Many of these patients have reported persistent lower respiratory symptoms (LRS) despite treatment for presumed asthma. Our goal was to identify conditions associated with persistent uncontrolled LRS despite standard asthma management. We recruited 60 patients who were uncontrolled at enrollment and, after a three-month run-in period on high-dose inhaled corticosteroid and long acting bronchodilator, reassessed their status as Uncontrolled or Controlled based on a score from the Asthma Control Test (ACT). Despite this treatment, only 11 participants (18%) gained Controlled status as defined by the ACT. We compared conditions associated with Uncontrolled and Controlled status. Those with Uncontrolled symptoms had higher rates of upper airway symptoms. Many patients had persistent bronchial hyper-reactivity (BHR) and upper airway hyper-reactivity as measured by paradoxical vocal fold movement (PVFM). We found a significant increasing trend in the percentage of Controlled with respect to the presence of BHR and PVFM. We were unable to identify significant differences in lung function or inflammatory markers in this small group. Our findings suggest persistent upper and lower airway hyper-reactivity that may respond to standard asthma treatment, whereas others with persistent LRS necessitate additional diagnostic evaluation, including a focus on the upper airway.
PMID: 32933057
ISSN: 1660-4601
CID: 4592962
Tracheostomy in COVID-19 Patients: Why Delay or Avoid? [Letter]
Kwak, Paul E; Persky, Michael J; Angel, Luis; Rafeq, Samaan; Amin, Milan R
PMID: 32808866
ISSN: 1097-6817
CID: 4566762
Recurrent Respiratory Papillomatosis Office versus Operating Room: Systematic Review and Meta-Analysis
Chen, Sophia; Connors, Joseph; Zhang, Yan; Wang, Binhuan; Vieira, Dorice; Shapira-Galitz, Yael; Garber, David; Amin, Milan R
OBJECTIVES/UNASSIGNED:Recurrent respiratory papillomatosis can be treated in the office or operating room (OR). The choice of treatment is based on several factors, including patient and surgeon preference. However, there is little data to guide the decision-making. This study examines the available literature comparing operative treatment in-office versus OR. METHODS/UNASSIGNED:A systematic review was performed following Preferred Reporting Items for Systematic Reviews guidelines. Of 2,864 articles identified, 78 were reviewed full-length and 18 were included. Outcomes of interest were recurrence and complication rates, number of procedures, time interval between procedures, and cost. RESULTS/UNASSIGNED:Only one study compared outcomes of operative in-office to OR treatments. The weighted average complication rate for OR procedures was 0.02 (95% confidence interval [CI] 0.00-0.32), n = 8, and for office procedures, 0.17 (95% CI 0.08-0.33), n = 6. The weighted average time interval between OR procedures was 10.59 months (5.83, 15.35) and for office procedures 5.40 months (3.26-7.54), n = 1. The weighted average cost of OR procedures was $10,105.22 ($5,622.51-14,587.83), n = 2 versus $2,081.00 ($1,987.64-$2,174.36), n = 1 for office procedures. CONCLUSION/UNASSIGNED:Only one study compares office to OR treatment. The overall data indicate no differences aside from cost and imply that office procedures may be more cost-effective than OR procedures. However, the heterogeneous data limits any strong comparison of outcomes between office and OR-based treatment of laryngeal papillomas. More studies to compare the two treatment settings are warranted.
PMID: 32781827
ISSN: 1943-572x
CID: 4556332