Publications by authors named "Diego Preciado"

116 Publications

Tympanostomy Tubes or Medical Management for Recurrent Acute Otitis Media.

N Engl J Med 2021 May;384(19):1789-1799

From the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).

Background: Official recommendations differ regarding tympanostomy-tube placement for children with recurrent acute otitis media.

Methods: We randomly assigned children 6 to 35 months of age who had had at least three episodes of acute otitis media within 6 months, or at least four episodes within 12 months with at least one episode within the preceding 6 months, to either undergo tympanostomy-tube placement or receive medical management involving episodic antimicrobial treatment. The primary outcome was the mean number of episodes of acute otitis media per child-year (rate) during a 2-year period.

Results: In our main, intention-to-treat analysis, the rate (±SE) of episodes of acute otitis media per child-year during a 2-year period was 1.48±0.08 in the tympanostomy-tube group and 1.56±0.08 in the medical-management group (P = 0.66). Because 10% of the children in the tympanostomy-tube group did not undergo tympanostomy-tube placement and 16% of the children in the medical-management group underwent tympanostomy-tube placement at parental request, we conducted a per-protocol analysis, which gave corresponding episode rates of 1.47±0.08 and 1.72±0.11, respectively. Among secondary outcomes in the main analysis, results were mixed. Favoring tympanostomy-tube placement were the time to a first episode of acute otitis media, various episode-related clinical findings, and the percentage of children meeting specified criteria for treatment failure. Favoring medical management was children's cumulative number of days with otorrhea. Outcomes that did not show substantial differences included the frequency distribution of episodes of acute otitis media, the percentage of episodes considered to be severe, and antimicrobial resistance among respiratory isolates. Trial-related adverse events were limited to those included among the secondary outcomes of the trial.

Conclusions: Among children 6 to 35 months of age with recurrent acute otitis media, the rate of episodes of acute otitis media during a 2-year period was not significantly lower with tympanostomy-tube placement than with medical management. (Funded by the National Institute on Deafness and Other Communication Disorders and others; ClinicalTrials.gov number, NCT02567825.).
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http://dx.doi.org/10.1056/NEJMoa2027278DOI Listing
May 2021

Tracheostomy on infants born in the periviable period: Outcomes at discharge from the neonatal intensive care unit (NICU).

Int J Pediatr Otorhinolaryngol 2021 Apr 27;146:110746. Epub 2021 Apr 27.

Department of Otorhinolaryngology H & N Surgery, University of Maryland School of Medicine and University of Maryland Children's Hospital, Baltimore, MD, USA.

Objectives: Advances in neonatal intensive care have allowed successful resuscitation of children born at the border of viability. However, there has been little change in the incidence of bronchopulmonary dysplasia (BPD) and anatomical upper airway obstruction which may require a tracheostomy in that group. The benefits of the procedure are accompanied by sequelae that impact outcomes. Information about these issues can assist caregivers in making decisions and planning care after discharge from the neonatal intensive care unit (NICU). The objectives of this study were to describe the clinical characteristics of neonates born in the periviable period (≤25 weeks gestation) requiring tracheotomy and to highlight their hospital course, complications and status upon NICU discharge.

Methods: Retrospective analysis at four tertiary care academic children's hospitals. Medical records of neonates born ≤25 weeks gestation who required tracheotomy between January 1, 2012 and December 31, 2018 were reviewed. Demographics, medical comorbidities, and tracheostomy related complications were studied. Feeding, ventilation, and neurodevelopmental outcomes at time of transfer from NICU were evaluated.

Results: Fifty-two patients were included. The mean gestational age was 24.3 (95% confidence interval, 24.1 to 24.5) weeks. The mean birth weight was 635 (95% CI: 603 to 667) grams and 50 (96.2%) children had BPD. At time of discharge from the NICU, 47 (90.4%) required mechanical ventilation, four (7.7%) required supplemental oxygen and one (1.9%) was weaned to room air. Forty-two (80.8%) were discharged with a gastrostomy tube, seven (28%) with a nasogastric tube, and three (5.8%) were on oral feeds. Two (3.8%) suffered hypoxic ischemic encephalopathy, 27 (51.9%) had neurodevelopmental delay, seven (13.5%) were diagnosed with another anomaly, and 16 (30.8%) were considered normal. Complications related to the procedure were observed in 28 (53.8%) neonates. Granulation tissue was seen in 17 (32.7%), wound break down or cellulitis in three (5.8%), one (1.9%) with tracheostomy plugging, three (5.8%) with dislodgement of the tracheostomy tube and four (7.7%) developed tracheitis.

Conclusions: Tracheostomy in infants born in the periviable period is primarily performed for BPD and portends extended ventilatory dependence. It is associated with non-oral alimentation at the time of discharge from the NICU and developmental delay. Mortality directly related to the procedure is rare. Minor complications are common but do not require surgical intervention. These data may aid in counseling caregivers about the procedure in this vulnerable population.
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http://dx.doi.org/10.1016/j.ijporl.2021.110746DOI Listing
April 2021

Sistrunk vs modified Sistrunk procedures: Does procedure type matter?

J Pediatr Surg 2021 Mar 26. Epub 2021 Mar 26.

Division of Pediatric Surgery, Department of Surgery, Children's Medical Center, University of Texas Southwestern, Dallas TX USA. Electronic address:

Background: Thyroglossal Duct Cyst (TDC) is the most common congenital neck mass in children and is surgically managed with a Sistrunk procedure. Some surgeons perform a modified Sistrunk (mSis), involving the dissection of the fistula beyond the hyoid bone without coring out the foramen cecum at the base of the tongue. We aim to evaluate surgical outcomes of children undergoing Sistrunk (Sis) or modified Sistrunk (mSis) procedures for TDC at an academic pediatric institution.

Materials And Methods: We conducted a retrospective chart review of the Children's National Medical Center database from 2004 to 2014. Basic demographic information, preoperative characteristics, postoperative complications, and recurrence were extracted for children diagnosed with TDC. We estimated descriptive statistics using Kruskal-Wallis tests and Pearson's chi-square for continuous and categorical values.

Results: 157 patients that underwent TDC excision were identified. Sistrunk (Sis) was performed in 52 cases (33%) and modified Sistrunk (mSis) performed in 105 (67%) cases. 84 (54%) were female and the mean age at surgery was 5.4 years (SD=4.5). Overall recurrence was detected in 8 cases (5.1%) and did not differ significantly by procedure type [2 (4%) in Sis and 6 (6%) in mSis, p = 0.616]. Post-operative complications did not differ significantly between Sis and mSis procedure: swelling [6 (12%) and 18 (17%), p = 0.481]; seroma [5 (10%) and 10 (10%), p = 1.00]; surgical site infection [3 (6%) and 8 (8%), p = 0.752]; or post-excision incision and drainage [3 (6%) and 9 (9%), p = 0.752] (respectively).

Conclusions: Our findings reveal no statistical difference in recurrence rates between Sis and mSis with no risk factors for recurrence identified. Furthermore, there was no difference in post-operative complications between the groups. Both surgical procedures were associated with few complications and low recurrence.
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http://dx.doi.org/10.1016/j.jpedsurg.2021.03.044DOI Listing
March 2021

Complex Pediatric Otolaryngology Subcertification-Now Is the Time.

JAMA Otolaryngol Head Neck Surg 2021 Apr 22. Epub 2021 Apr 22.

Department of Otolaryngology-Head & Neck Surgery, George Washington University, Children's National Hospital, Washington, DC.

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http://dx.doi.org/10.1001/jamaoto.2021.0533DOI Listing
April 2021

Effects of Premedication With Midazolam on Recovery and Discharge Times After Tonsillectomy and Adenoidectomy.

Cureus 2021 Feb 3;13(2):e13101. Epub 2021 Feb 3.

Anesthesiology, Children's National Medical Center, Washington, D.C., USA.

Background Midazolam is commonly used preoperatively for anxiety. Adverse effects data in pediatric patients with obstructive sleep apnea (OSA) undergoing tonsillectomy and adenoidectomy (T&A) is limited. Aims We hypothesized that preoperative midazolam increases the time to emergence from anesthesia and postoperative discharge. Secondary objectives assessed if patients receiving midazolam experienced increased side effects or complications from treatment. Methods This study was a retrospective chart review of patients undergoing T&A from July 2014 to December 2015. Midazolam receiving patients (midazolam group: MG) were compared to patients who did not (non-midazolam group: NMG). Multivariable analyses were performed and adjusted for predefined potential cofounder variables. Results Emergence and discharge times were 5.2 minutes (95% CI [-7.1, 17.4]; p=0.41) and 10.1 minutes (95% CI [-6.7, 26.8]; p=0.24) longer in MG. These results were not statistically significant. Comparing by OSA status, there was no statistical difference in emergence and discharge times between mild, moderate and severe OSA groups or between MG and NMG within each OSA group. Emergence and discharge times in moderate OSA was 6.1 minutes (95% CI [-17.6, 29.8]; p=0.61) and 18.8 minutes (95% CI [-16.4, 53.9]; p=0.29) longer than mild OSA, and in the severe OSA group, 2.6 minutes (95% CI [-19.9, 25.1]; p=0.82) shorter and 2.8 minutes (95% CI [-30.3, 35.9]; p=0.87) longer. The incidence of postoperative complications was comparable between MG and NMG groups. Conclusions Premedication with midazolam was not associated with prolonged emergence or discharge time or higher incidence of complications after anesthesia for T&A in patients with OSA.
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http://dx.doi.org/10.7759/cureus.13101DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7935262PMC
February 2021

Barriers to Decannulation After Double-Stage Laryngotracheal Reconstruction.

Laryngoscope 2021 Feb 26. Epub 2021 Feb 26.

Division of Pediatric Otolaryngology, Children's National Hospital, Washington, District of Columbia, U.S.A.

Objectives/hypothesis: To identify any potential barriers for decannulation in children undergoing double-staged laryngotracheal reconstruction (dsLTR) beyond the severity of disease itself.

Study Design: Case series with chart review.

Methods: We performed a retrospective chart review from 2008 to 2018 of 41 children who had undergone dsLTR as primary treatment for laryngotracheal stenosis at a stand-alone tertiary children's hospital. We examined the effect of demographic, medical, and surgical factors on successful decannulation and time to decannulation after dsLTR.

Results: Of the 41 children meeting inclusion criteria who underwent dsLTR, 34 (82%) were decannulated. Age, gender, race, insurance status, medical comorbidity, and multilevel stenosis did not predict overall decannulation. Insurance status did not impact time to decannulation (P = .13, Log-rank). Factors that increased length of time to decannulation were the use of anterior and posterior cartilage grafts (P = .001, Log-rank), history of pulmonary disease (P = .05, Log rank), history of cardiac disease (P = .017, Log-rank), and race/ethnicity (P = .001 Log-rank).

Conclusion: In a cohort with a similar decannulation rates to previous dsLTR cohorts, we identified no demographic or medical factors that influenced overall decannulation. We did observe that pulmonary comorbidity, cardiac comorbidity, and race/ethnicity lengthens time to decannulation.

Level Of Evidence: 4 Laryngoscope, 2021.
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http://dx.doi.org/10.1002/lary.29486DOI Listing
February 2021

Defining the patterns of PAP adherence in pediatric obstructive sleep apnea: a clustering analysis using real-world data.

J Clin Sleep Med 2021 May;17(5):1005-1013

Division of Pediatric Pulmonary and Sleep Medicine, Children's National Hospital, George Washington University, Washington, DC.

Study Objectives: The implementation of positive airway pressure (PAP) therapy to treat obstructive sleep apnea in children is a complex process. PAP therapy data are highly heterogeneous in pediatrics, and the clinical management cannot be generalized. We hypothesize that pediatric PAP users can be subgrouped via clustering analysis to guide tailored interventions.

Methods: PAP therapy data for 250 children with obstructive sleep apnea were retrospectively examined using unsupervised hierarchical cluster analysis based on (1) PAP tolerance (average hours on days used) and (2) consistency of PAP use (percentage of days used). Clinical features in each cluster were defined, and a tree decision analysis was generated for clinical implementation.

Results: We were able to subclassify all 250 children (median age = 11.5 years) into five clusters: A (13.6%), B (29.6%), C (17.6%), D (16.4%), and E (22.8%). The clusters showed significant differences in PAP use patterns (Kruskal-Wallis P value < 1e-16). The most consistent PAP use patterns were seen in clusters A, B, and C. Major differences across clusters included the prevalence of obesity, PAP setting, developmental delay, and adenotonsillectomy. We also identified important differences in mask acceptance, OSA severity, and individual responses to PAP therapy based on objective apnea-hypopnea reductions in PAP downloads.

Conclusions: A simple method to subset PAP use patterns in children can be implemented by analyzing cloud-based PAP therapy data. This novel approach may contribute to optimization of PAP therapy in children of all ages based on real-world evidence at the individual level.
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http://dx.doi.org/10.5664/jcsm.9100DOI Listing
May 2021

Systemic Bevacizumab for Treatment of Respiratory Papillomatosis: International Consensus Statement.

Laryngoscope 2021 Jun 6;131(6):E1941-E1949. Epub 2021 Jan 6.

Department of Otolaryngology-Head and Neck Surgery, University of Texas (UT) Southwestern Medical Center, Dallas, Texas, U.S.A.

Objectives/hypothesis: The purpose of this study is to develop consensus on key points that would support the use of systemic bevacizumab for the treatment of recurrent respiratory papillomatosis (RRP), and to provide preliminary guidance surrounding the use of this treatment modality.

Study Design: Delphi method-based survey series.

Methods: A multidisciplinary, multi-institutional panel of physicians with experience using systemic bevacizumab for the treatment of RRP was established. The Delphi method was used to identify and obtain consensus on characteristics associated with systemic bevacizumab use across five domains: 1) patient characteristics; 2) disease characteristics; 3) treating center characteristics; 4) prior treatment characteristics; and 5) prior work-up.

Results: The international panel was composed of 70 experts from 12 countries, representing pediatric and adult otolaryngology, hematology/oncology, infectious diseases, pediatric surgery, family medicine, and epidemiology. A total of 189 items were identified, of which consensus was achieved on Patient Characteristics (9), Disease Characteristics (10), Treatment Center Characteristics (22), and Prior Workup Characteristics (18).

Conclusion: This consensus statement provides a useful starting point for clinicians and centers hoping to offer systemic bevacizumab for RRP and may serve as a framework to assess the components of practices and centers currently using this therapy. We hope to provide a strategy to offer the treatment and also to provide a springboard for bevacizumab's use in combination with other RRP treatment protocols. Standardized delivery systems may facilitate research efforts and provide dosing regimens to help shape best-practice applications of systemic bevacizumab for patients with early-onset or less-severe disease phenotypes.

Level Of Evidence: 5 Laryngoscope, 131:E1941-E1949, 2021.
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http://dx.doi.org/10.1002/lary.29343DOI Listing
June 2021

Factors influencing time to operating room in children presenting with post-tonsillectomy hemorrhage.

Int J Pediatr Otorhinolaryngol 2021 Feb 20;141:110581. Epub 2020 Dec 20.

Division of Pediatric Otolaryngology, Children's National Hospital, Washington, DC, USA. Electronic address:

Objectives: We aimed to evaluate factors associated with time to return to OR in children presenting with post-tonsillectomy hemorrhage to a tertiary children's hospital.

Methods: Retrospective study of pediatric patients presenting to a single institution from January 2012 to January 2020, with post-tonsillectomy hemorrhage (PTH) requiring surgical intervention for control of bleeding. Correlation, univariate, and multivariate analysis were conducted.

Results: Of 15,984 tonsillectomies performed at our institution during the study period, 144 required return to the OR for bleeding control, in addition to 15 other children whose tonsillectomy had been performed at an outside institution. Mean time to the OR was 119.7 min (SD 101.5) in the morning, 77.4 min (SD 60.6) in the afternoon, 55.6 min (SD 34.8) in the evening, and 49.4 min (SD 26.4) overnight (ANOVA p < 0.0001). The mean hemoglobin decline from pre-to post-tonsillectomy was 1.3 g/dl (SD 1.7). Primary hemorrhages had a mean time to OR of 62.39 min (SD 63.42) while secondary hemorrhages mean time to OR was 85.54 min (SD 76.21) (p = 0.0064). There was no significant difference in time to OR among race/ethnicity (p = 0.928), insurance status (p = 0.359), weekday (p = 0.557), surgeon seniority (p = 0.8104) or by hemoglobin drop (p = 0.2773). When controlling for each of these variables, multiple linear regression showed that only time of day had significant correlation with time to OR (p = 0.0003).

Conclusion: At a tertiary children's hospital, patients presenting with PTH requiring revision surgery waited the longest to get to the OR in the morning versus all other times of day. These results can aid in individualization of anticipatory guidance in order to reduce morbidity and mortality from complications requiring revision in the operating room.
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http://dx.doi.org/10.1016/j.ijporl.2020.110581DOI Listing
February 2021

Review of otitis media microbiome studies: What do they tell us?

Laryngoscope Investig Otolaryngol 2020 Oct 21;5(5):936-940. Epub 2020 Sep 21.

Division of Pediatric Otolaryngology Head and Neck Surgery, Children's National Health System Washington District of Columbia USA.

Objectives: To provide a state of the art review on accruing studies focused on defining the middle ear microbiome, highlighting the relationship of the microbiome to disease pathophysiology.

Data Sources: Pubmed indexed peer-reviewed articles and published textbooks.

Review Methods: Comprehensive review of the literature using the following search terms: "microbiome" "bacterial pathogens" with the term "otitis media," and "middle ear."

Results: A multitude of microbiome studies have been published in the recent past. In general findings from these studies underscore distinct profiles based on disease category. The adenoidal reservoir theory may not explain all etiologies of middle ear effusion production. The host immune system appears to be associated to the bacterial population identified in the middle ear space. Atopic respiratory diseases correlate to the middle ear microbiome. Some novel middle ear bacterial genera may be protective in terms of disease.

Conclusion: The understanding of otitis media disease progression pathophysiology is evolving, informed by accruing middle ear microbiomic data. The functional implications of middle ear microbiome findings need to be studied further. This may help counterbalance probiotic vs antibiotic approaches to disease mitigation.
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http://dx.doi.org/10.1002/lio2.460DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7585249PMC
October 2020

Competency-Based Assessment Tool for Pediatric Esophagoscopy: International Modified Delphi Consensus.

Laryngoscope 2021 05 9;131(5):1168-1174. Epub 2020 Oct 9.

Department of Otolaryngology, Head and Neck Surgery, Stanford University, Lucile Salter Packard Children's Hospital, Palo Alto, California, U.S.A.

Objectives/hypothesis: Create a competency-based assessment tool for pediatric esophagoscopy with foreign body removal.

Study Design: Blinded modified Delphi consensus process.

Setting: Tertiary care center.

Methods: A list of 25 potential items was sent via the Research Electronic Data Capture database to 66 expert surgeons who perform pediatric esophagoscopy. In the first round, items were rated as "keep" or "remove" and comments were incorporated. In the second round, experts rated the importance of each item on a seven-point Likert scale. Consensus was determined with a goal of 7 to 25 final items.

Results: The response rate was 38/64 (59.4%) in the first round and returned questionnaires were 100% complete. Experts wanted to "keep" all items and 172 comments were incorporated. Twenty-four task-specific and 7 previously-validated global rating items were distributed in the second round, and the response rate was 53/64 (82.8%) with questionnaires returned 97.5% complete. Of the task-specific items, 9 reached consensus, 7 were near consensus, and 8 did not achieve consensus. For global rating items that were previously validated, 6 reached consensus and 1 was near consensus.

Conclusions: It is possible to reach consensus about the important steps involved in rigid esophagoscopy with foreign body removal using a modified Delphi consensus technique. These items can now be considered when evaluating trainees during this procedure. This tool may allow trainees to focus on important steps of the procedure and help training programs standardize how trainees are evaluated.

Level Of Evidence: 5. Laryngoscope, 131:1168-1174, 2021.
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http://dx.doi.org/10.1002/lary.29126DOI Listing
May 2021

Pediatric Otolaryngology in the COVID-19 Era.

Otolaryngol Clin North Am 2020 Dec 19;53(6):1171-1174. Epub 2020 Aug 19.

Division of Pediatric Otolaryngology, Department of Otolaryngology, Pediatrics, and Plastic Surgery, Hassenfeld Children's Hospital at NYU Langone, NYU Langone Health, 240 East 38th Street, New York, NY 10016, USA.

Although the majority of attention to the health care impact of COVID-19 has focused on adult first responders and critical care providers, the pandemic has had a profound effect on the entire health care industry, including the pediatric otolaryngology community. This article highlights the unique ramifications of COVID-19 on pediatric otolaryngology, with a focus on the immediate and potential long-term shifts in practice. Specifically, the article is divided into 3 sections (care for the patient, care for the practitioner, and care for the practice) and details the unique effects of the pandemic on the pediatric otolaryngology specialty.
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http://dx.doi.org/10.1016/j.otc.2020.08.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7437513PMC
December 2020

Retained Tympanostomy Tubes: Who, What, When, Why, and How to Treat?

Ear Nose Throat J 2020 Aug 31:145561320950490. Epub 2020 Aug 31.

Division of Pediatric Otolaryngology, Head and Neck Surgery, 43989Children's National Health System, Washington, DC, USA.

Background: Tympanostomy tube placement is one of the most common surgical procedures performed across the globe. Controversies exist regarding what to do when a tube is considered to be retained in the tympanic membrane for too long.

Materials And Methods: Review of the PubMed medical literature starting in 1990, focusing on English language studies reporting on the definition, complications, and management of retained tympanostomy tubes.

Results: The medical literature reporting on outcomes regarding retained tympanostomy tubes is relatively sparse. Most studies recommend prophylactic removal of tubes after a defined period of time, usually around 2 to 3 years after placement. A preferred method of myringoplasty after tympanostomy tube retrieval has not been established, but most studies recommend grafting the perforation at the time of tube removal.

Conclusions: Although a consensus as to the optimal management of retained tympanostomy tubes is not yet established in the medical literature, a preponderance of studies recommend prophylactic removal at defined period of time (>2-3 years) before the onset of complications such as otorrhea and granulation tissue formation. Due to a lack of best evidence, the surgeon's preference remains the guiding principle as to the best technique for myringoplasty at the time of removal.
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http://dx.doi.org/10.1177/0145561320950490DOI Listing
August 2020

A current render of pediatric otolaryngology in the United States.

Authors:
Diego Preciado

Pediatr Investig 2019 Sep 26;3(3):133-136. Epub 2019 Sep 26.

Division of Pediatric Otolaryngology, Head and Neck Surgery Children's National Health System Washington DC USA.

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http://dx.doi.org/10.1002/ped4.12139DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7331395PMC
September 2019

MUC5B induces in vitro neutrophil extracellular trap formation: Implication in otitis media.

Laryngoscope Investig Otolaryngol 2020 Jun 23;5(3):536-545. Epub 2020 May 23.

Sheikh Zayed Institute for Pediatric Surgical Innovation Children's National Health System Washington District of Columbia USA.

Background: Chronic otitis media (COM) is characterized by middle ear fluid predominantly containing cytokines, (NTHi), the mucin MUC5B, and neutrophil extracellular traps (NETs). NETs consist of extracellular DNA coated with antibacterial proteins such as myeloperoxidase (MPO) and citrullinated histone 3 (CitH3). NETs can damage tissues and sustain inflammation. Our study aimed to develop an in vitro model of NETosis, testing COM inductors.

Methods: NETosis was evaluated in fresh blood human neutrophils attached to collagen-coated plates and in suspension exposed to phorbol myristate acetate (PMA) as a control, and COM relevant mediators. Confocal microscopy, DNA fluorescence assay and flow cytometry were used to quantify NETosis.

Results: PMA exposure induced DNA, MPO, and CitH3 by immunofluorescence (IF) most significantly at 3 hours (3.8-fold for DAPI, 7.6-fold for MPO, and 6.9-fold for CitH3, all  < .05). IL-8 and TNF-α cytokines showed milder increases of DAPI, MPO, and CitH3 positive cells. NTHi had no effect on these NETs markers. Purified salivary MUC5B (10 to 40 μg/mL) produced potent increases, comparable to PMA. A composite NET score summing the fold-increases for DAPI, MPO, and CitH3 demonstrated PMA at 13.6 to 19 relative to control set at 1; and MUC5B at 8.6 to 16.3 (all  < .05). IL-8 and TNF-α showed scores of 5.4 and 3, respectively, but these were not statistically significant.

Conclusion: We developed a reliable in vitro assay for NETosis which demonstrated that salivary MUC5B is a potent inductor of NETs whereas IL-8, TNF-α, live and lyzed NTHi demonstrated minimal to no NETosis.

Level Of Evidence: NA.
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http://dx.doi.org/10.1002/lio2.396DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7314476PMC
June 2020

Tracheostomy in the Extremely Premature Neonate: A Multi-Institutional Study.

Otolaryngol Head Neck Surg 2020 Apr 25;162(4):559-565. Epub 2020 Feb 25.

Department of Otorhinolaryngology-Head and Neck Surgery, University of Maryland School of Medicine and University of Maryland Children's Hospital, Baltimore, Maryland, USA.

Objective: (1) To describe characteristics associated with tracheostomy placement and (2) to describe associated in-hospital morbidity in extremely premature infants.

Study Design: Pooled retrospective analysis of charts.

Setting: Academic children's hospitals.

Subjects And Methods: The patient records of premature infants (23-28 weeks gestational age) who underwent tracheostomy between January 1, 2012, and December 31, 2017, were reviewed from 4 academic children's hospitals. Demographics, procedural morbidity, feeding, respiratory, and neurodevelopmental outcomes at the time of transfer from the neonatal intensive care unit (NICU) were obtained. The contribution of baseline characteristics to mortality, neurodevelopmental, and feeding outcomes was also assessed.

Results: The charts of 119 infants were included. The mean gestational age was 25.5 (95% confidence interval, 25.2-25.7) weeks. The mean birth weight was 712 (671-752) g. Approximately 50% was African American. The principal comorbidity was chronic lung disease (92.4%). Overall, 60.5% of the infants had at least 1 complication. At the time of transfer, most remained mechanically ventilated (94%) and dependent on a feeding tube (90%). Necrotizing enterocolitis increased the risk of feeding impairment ( = .002) and death ( = .03).

Conclusions: Tracheostomy in the extremely premature neonate is primarily performed for chronic lung disease. Complications occur frequently, with skin breakdown being the most common. Placement of a tracheostomy does not seem to mitigate the systemic morbidity associated with extreme prematurity.
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http://dx.doi.org/10.1177/0194599820905528DOI Listing
April 2020

Otitis Media Middle Ear Effusion Identification and Characterization Using an Optical Coherence Tomography Otoscope.

Otolaryngol Head Neck Surg 2020 03 21;162(3):367-374. Epub 2020 Jan 21.

Division of Pediatric Otolaryngology, Children's National Health System (CNHS), Washington, DC, USA.

Objective: To determine the feasibility of detecting and differentiating middle ear effusions (MEEs) using an optical coherence tomography (OCT) otoscope.

Study Design: Cross-sectional study.

Setting: US tertiary care children's hospital.

Subjects And Methods: Seventy pediatric patients undergoing tympanostomy tube placement were preoperatively imaged using an OCT otoscope. A blinded reader quiz was conducted using 24 readers from 4 groups of tiered medical expertise. The primary outcome assessed was reader ability to detect presence/absence of MEE. A secondary outcome assessed was reader ability to differentiate serous vs nonserous MEE.

Results: OCT image data sets were analyzed from 45 of 70 total subjects. Blinded reader analysis of an OCT data subset for detection of MEE resulted in 90.6% accuracy, 90.9% sensitivity, 90.2% specificity, and intra/interreader agreement of 92.9% and 87.1%, respectively. Differentiating MEE type, reader identification of nonserous MEE had 70.8% accuracy, 53.6% sensitivity, 80.1% specificity, and intra/interreader agreement of 82.9% and 75.1%, respectively. Multivariate analysis revealed that age was the strongest predictor of OCT quality. The mean age of subjects with quality OCT was 5.01 years (n = 45), compared to 2.54 years (n = 25) in the remaining subjects imaged ( = .0028). The ability to capture quality images improved over time, from 50% to 69.4% over the study period.

Conclusion: OCT otoscopy shows promise for facilitating accurate MEE detection. The imageability with the prototype device was affected by age, with older children being easier to image, similar to current ear diagnostic technologies.
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http://dx.doi.org/10.1177/0194599819900762DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7289273PMC
March 2020

Panel 2- recent advance in otitis media bioinformatics.

Int J Pediatr Otorhinolaryngol 2020 Mar 18;130 Suppl 1:109834. Epub 2019 Dec 18.

Objectives: To update the medical literature on recent large-scale studies employing bioinformatics data analysis tools in otitis media (OM) disease models with a principal focus on developments in the past 5 years.

Data Sources: Pubmed indexed peer-reviewed articles.

Review Methods: Comprehensive review of the literature using the following search terms: 'genomics, inflammasome, microRNA, proteomics, transcriptome, bioinformatics' with the term 'otitis media', and 'middle ear'. Included articles published in the English language from January 1, 2015-April 1, 2019.

Implications For Practice: Large scale bioinformatics tools over the past five years lend credence to the paradigm of innate immune response playing a critical role in host defense against bacteria contributing to Otitis Media (OM) progression from acute to chronic. In total, genomic, miRNAomic, and proteomic analyses all point to the need for a tightly regulated innate immune and inflammatory response in the middle ear. Currently, there is an urgent need for developing novel therapeutic strategies to control immunopathology and tissue damage, improve hearing and enhance host defense for both acute and chronic OM based on full understanding of the basic molecular pathogenesis of OM.
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http://dx.doi.org/10.1016/j.ijporl.2019.109834DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7184535PMC
March 2020

Human primary middle ear epithelial cell culture: A novel in vitro model to study otitis media.

Laryngoscope Investig Otolaryngol 2019 Dec 27;4(6):663-672. Epub 2019 Nov 27.

Sheikh Zayed Center for Pediatric Surgical Innovation and Division of Otolaryngology Children's National Health System Washington District of Columbia U.S.A.

Objectives: Otitis media (OM) is a ubiquitous pediatric disease leading to a significant health care burden. There is no medication beneficial to resolving COM fluid, highlighting the need for research in the field. Crucially, current human middle ear epithelial cell models are transformed cells not recapitulating physiological functions. Herein, we describe a new method to proliferate and differentiate pediatric primary middle ear epithelial cells (pMEEC) from patients as a physiological model for the study of OM.

Methods: We adapted a cell reprogramming protocol using irradiated fibroblast feeder medium in addition to Rho kinase inhibitor to proliferate pMEEC collected during cochlear implant surgery. Cells were plated on transwell membranes, proliferated with conditionally reprogrammed culture medium, and transferred to air-liquid interface (ALI). Cultures were maintained for 4 weeks at ALI, photos were taken and cell lysates and secretions were collected over time for characterization analysis using quantitative polymerase chain reaction, Western bolt, and proteomics. Keratins, MUC5B and MUC5AC mucins, and beta tubulin (TUBB) were analyzed at the mRNA and protein level.

Results: Cultures took a mean of 2 weeks to proliferate before transwell plating and forming a tight epithelium at ALI from 2 to 4 weeks. Although mRNA expression of MUC5B, MUC5AC, TUBB, and keratin 5 (KRT5) were variable depending on the differentiation stage and the patient, both TUBB and KRT5 proteins were detected until week 2.

Conclusion: We demonstrate a novel method to proliferate and differentiate pMEECs that express epithelial markers and that are able to secrete mucins for the study of OM.

Level Of Evidence: NA.
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http://dx.doi.org/10.1002/lio2.319DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6929573PMC
December 2019

Sedation withdrawal following single stage laryngotracheal reconstruction: Does dexmedetomidine help?

Int J Pediatr Otorhinolaryngol 2020 Feb 31;129:109758. Epub 2019 Oct 31.

Department of Otolaryngology, Children's National Health System, 111 Michigan Avenue, Washington, DC, 20010, USA. Electronic address:

Objectives: Single-stage laryngotracheal reconstruction (SS-LTR) requires a period of post-operative intubation, during which time adequate sedation is needed to ensure graft healing. Commonly used agents include benzodiazepines, opioids, and more recently, dexmedetomidine, a centrally-acting α adrenoreceptor. This study aims to compare withdrawal outcomes between various sedation regimens following SS-LTR.

Methods: Retrospective chart review of 56 patients who underwent SS-LTR between 2008 and 2018 at a tertiary free-standing children's hospital was performed. Of 47 patients with complete records, 18 patients received dexmedetomidine for >75% of their intubation period with midazolam (DexWM), 9 received dexmedetomidine for >75% without midazolam (DexWOM), and 20 received dexmedetomidine for <75% with midazolam (noDex).

Results: There was no significant difference in length of PICU or hospital stay between the groups. The noDex group trended toward a higher re-intubation rate of 25%, as compared with 11% of DexWOM and 5.6% of DexWM (p = 0.21). There was no significant difference in days of oral sedation taper required or Withdrawal Assessment Tool (WAT-1) score for post-extubation days 1 and 3. By post-extubation day 5, 100% of the DexWM group had WAT-1 scores <3 as compared with 71.4% of the noDex group (p = 0.037). Notably, lower average daily doses of dexmedetomidine and midazolam were used in the DexWM group, as compared with the DexWOM and noDex groups, respectively.

Conclusion: Dexmedetomidine as a primary sedation agent with midazolam allows for adequate sedation following SS-LTR. The combination of the two drugs in the DexWM group not only reduced the dosage of each drug needed, but also significantly improved WAT-1 scores by post-extubation day 5, as compared with the alternative sedation regimens.
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http://dx.doi.org/10.1016/j.ijporl.2019.109758DOI Listing
February 2020

Altered Middle Ear Microbiome in Children With Chronic Otitis Media With Effusion and Respiratory Illnesses.

Front Cell Infect Microbiol 2019 4;9:339. Epub 2019 Oct 4.

Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, Computational Biology Institute, The George Washington University, Washington, DC, United States.

Chronic otitis media with effusion (COME) is a common childhood disease characterized by an accumulation of fluid behind the eardrum. COME often requires surgical intervention and can also lead to significant hearing loss and subsequent learning disabilities. Recent characterization of the middle ear fluid (MEF) microbiome in pediatric patients has led to an improved understanding of the microbiota present in the middle ear during COME. However, it is not currently known how the MEF microbiome might vary due to other conditions, particularly respiratory disorders. Here, we apply an amplicon sequence variant (ASV) pipeline to MEF 16S rRNA high-throughput sequencing data from 50 children with COME (ages 3-176 months) undergoing tube placement. We achieve a more detailed taxonomic resolution than previously reported, including species and genus level resolution. Additionally, we provide the first report of the functional roles of the MEF microbiome and demonstrate that despite high taxonomic diversity, the functional capacity of the MEF microbiome remains uniform between patients. Furthermore, we analyze microbiome differences between children with COME with and without a history of lower airway disease (i.e., asthma or bronchiolitis). The MEF microbiome was less diverse in participants with lower airway disease than in patients without, and phylogenetic β-diversity (weighted UniFrac) was significantly different based on lower airway disease status. Differential abundance between patients with lower airway disease and those without was observed for the genera , and . These findings support previous suggestions of a link between COME and respiratory illnesses and emphasize the need for future study of the middle ear and respiratory tract microbiomes in diseases such as asthma and bronchiolitis.
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http://dx.doi.org/10.3389/fcimb.2019.00339DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6787523PMC
June 2020

Airway Papillomatosis: New Treatments for an Old Challenge.

Front Pediatr 2019 18;7:383. Epub 2019 Sep 18.

Sheikh Zayed Center for Pediatric Surgical Innovation, Children's National Health System, Washington, DC, United States.

Recurrent respiratory papillomatosis (RRP) is the recurrent growth of small, benign tumors, or papillomas, in the respiratory tract, caused by human papillomavirus (HPV). Currently, there is no cure. Palliative treatments seek to prevent airway obstruction, keep underlying tissues healthy, and maintain voice quality. The most common intervention, the local surgical removal of papillomas, may be inadequate as a standalone treatment for pediatric populations that experience rapid papilloma regrowth, as repeated surgeries cause increased damage to the surrounding tissues and impose significant emotional and economic burden on families. Interferon α and Cidofovir have been shown to lengthen the time between surgical interventions and/or decrease the total number of procedures needed, although the evidence of their efficacy and safety is controversial. Novel therapies, including photodynamic therapy, indole-3-carbinol, anti-reflux medication, heat shock protein, and Mumps and HPV vaccination, may provide potential avenues for treatment, but require further research. Among all the novel therapies investigated, systemic bevacizumab seems to offer the most promising alternative to surgery. Randomized control trials to investigate its impact, especially in a pediatric population, should be conducted before implementing it as a standard form of care. This review will summarize the latest literature on medical care for aggressive RRP disease.
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http://dx.doi.org/10.3389/fped.2019.00383DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6759931PMC
September 2019

Systemic bevacizumab for end-stage juvenile recurrent respiratory papillomas: A case report.

Int J Pediatr Otorhinolaryngol 2020 Jan 8;128:109706. Epub 2019 Oct 8.

Division of Pediatric Otolaryngology, Children's National Health System, Washington, DC, USA. Electronic address:

We report on two cases of severe recurrent respiratory papillomatosis (RRP) involvement where the anti-vascular endothelial growth factor (VEGF) antibody bevacizumab IV has been administered for treatment. Notably, there have not been any episodes of urgent transfer to the hospital for obstructive events since the bevacizumab was started. It is important to note however, that the disease has not been eliminated. While some pulmonary nodules continue to grow, they have become cavitated. Overall, the number and size of pulmonary lesions has decreased. Therefore, VEGF-targeted therapies, Bevacizumab, could prove to be a promising novel approach for long-term treatment of severe RRP.
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http://dx.doi.org/10.1016/j.ijporl.2019.109706DOI Listing
January 2020

Otitis media: what is new?

Curr Opin Otolaryngol Head Neck Surg 2019 Dec;27(6):495-498

Division of Pediatric Otolaryngology, Head and Neck Surgery, Children's National Health System, Washington, DC, USA.

Purpose Of Review: To review the latest literature on otitis media diagnosis, guidelines, treatment, and pathophysiology.

Recent Findings: Although otitis media remains one of the most common reasons for outpatient visits, antibiotic prescriptions, and surgery in the United States, little progress has been made in terms of developing novel treatments for the prevention and resolution of this condition, indicating the urgent need to continue investigations into the pathophysiology of this disorder. The recent past has seen the publication of new guidelines for the management of both acute otitis media, chronic otitis media and tympanostomy tube placement. Exciting technologies are being investigated into novel means to improve the diagnosis of otitis media, reviewed herein. Advancements in mucosal immunology and genetics have offered clues as to the underlying pathophysiology influencing otitis media propensity. Future research into modifying these pathophysiologic underpinnings, potentially through the usage of transtympanic drug delivery systems, should greatly influence the management of this condition.

Summary: Research into novel methods for otitis media pathophysiology, diagnosis and treatment has seen great strides in the recent past. Avenues towards markedly altering the evaluation and management of the condition are likely to be adopted into clinical practice over the coming years.
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http://dx.doi.org/10.1097/MOO.0000000000000591DOI Listing
December 2019

Index of pediatric voice handicap: Translation, transculturalization and validation to Argentinian Spanish.

Int J Pediatr Otorhinolaryngol 2019 Dec 11;127:109663. Epub 2019 Sep 11.

Hospital de Pediatría J.P. Garrahan, Buenos Aires, Argentina.

Objective: Voice disorders are very common in the pediatric population, with 6% and 23% of all children presenting with some form of dysphonia [1,2]. For many years, these patients have been underdiagnosed. There has been increasing awareness and interest in the study of voice alterations in children, and, most importantly, their impact in their quality of life. To do this, an instrument capable of measuring the quality of life in pediatric patients with vocal pathology is required, which can be used extensively in the scientific community. The objective of our study is to carry out the translation, transculturalization and validation of pVHI (Pediatric Voice Handicap Index) to Argentinian Spanish-speakers.

Material And Methods: A study was carried out in the Hospital de Pediatria Dr. JP Garrahan in the city of Buenos Aires, Argentina. It included patients between 3 and 18 years old. The pVHI was translated and transculturalized for said population and for its validation, a survey was carried out in two groups of patients: one group being children with a background of both reconstructive larynx surgery, and dysphonia (n = 35) and the other group being control patients, without any voice pathology (n = 35). The survey was conducted among either parents or caregivers of the children in question.

Results: A significant difference was found between both groups, for both overall pVHI score and survey subgroups score (p < 0.001) with an optimal internal confidence and a good Alpha Cronbach for each of the subgroups (functional 0,92; organic 0,87 and emotional 0,88). Test-retest for reliability revealed "p-values" without any significant difference (p > 0.05) for each of all subgroups (functional 0,68; organic 0,32 and emotional 0,72).

Conclusion: The validation and transculturalization of the rate of pediatric vocal impairment to Argentinian Spanish population presented an adequate validity and reliability. The rate of pediatric vocal impairment was identified through this simple and practical survey, offering additional information on the child's own vocal perception by part of the caregiver. We recommend this survey being included as a valuable tool in the evaluation of pediatric dysphonia in Spanish-speaking families.
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http://dx.doi.org/10.1016/j.ijporl.2019.109663DOI Listing
December 2019

Quality of life outcomes following velopharyngeal insufficiency surgery.

Int J Pediatr Otorhinolaryngol 2019 Dec 14;127:109643. Epub 2019 Aug 14.

Department of Otolaryngology, Children's National Health System, 111 Michigan, Washington, DC, 20010, USA; Division of Otolaryngology, George Washington University, 2300 M St, Washington, DC, 20037, USA. Electronic address:

Objectives: Velopharyngeal insufficiency (VPI) may be due to functional or anatomic causes, and can lead to speech deficits, communication difficulty, and emotional strain on patients and their caregivers. The VPI Effects on Life Outcomes (VELO) instrument quantifies quality of life outcomes in VPI patients both before and after VPI surgery. This study aims to identify pre-operative patient characteristics associated with better post-operative quality of life.

Methods: This study is a retrospective chart review of 51 patients who underwent VPI surgery between 2009 and 2018 at a tertiary free-standing children's hospital. A 26-item parent-proxy VELO questionnaire was administered by telephone to parents to assess their child's quality of life post-VPI surgery.

Results: Twenty-seven parents responded to the VELO questionnaire. Average post-operative VELO score was significantly higher in non-syndromic patients as compared with syndromic patients. Average post-operative VELO score was not significantly different between patients with and without submucous cleft (SMC) or those with mild to moderate versus severe pre-operative hypernasality. On multivariate analysis, absence of genetic syndrome, lack of submucous cleft, and presence of severe-pre-operative hypernasality were significantly and positively associated with increased post-operative VELO scores.

Conclusion: Children who undergo VPI surgery are more likely to have better post-operative quality of life outcomes if their VPI was not associated with a genetic syndrome or submucous cleft. Non-syndromic and non-SMC patients with severe pre-operative hypernasality may benefit significantly from VPI surgery and have improved post-operative quality of life.
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http://dx.doi.org/10.1016/j.ijporl.2019.109643DOI Listing
December 2019

Pilot study of the potential of 3D ultrasound to measure tonsillar volume and hypertrophy.

Int J Pediatr Otorhinolaryngol 2019 Nov 31;126:109612. Epub 2019 Jul 31.

Children's National Medical Center, Otolaryngology, 111 Michigan Ave, NW, Washington, DC, 20010, USA. Electronic address:

Objective: Obstructive sleep apnea (OSA), results in approximately 4-5 million outpatient visits per year in the United States. In pediatric patients, OSA is primarily caused by adenotonsillar hypertrophy, and therefore, adenotonsillectomy remains an effective surgical treatment. We investigate whether 3D ultrasound (3DUS) imaging can accurately and objectively assess tonsillar hypertrophy for the potential identification and stratification of candidates for adenotonsillectomy.

Methods: A prospective study was performed evaluating pediatric patients (N = 17) between the ages of 4-14 years who were undergoing adenotonsillectomy for OSA symptoms. On the day of surgery, tonsillar ultrasound was performed by a single attending radiologist. Tonsillectomy was performed and each tonsils' principal axes and physical volume by water submergence were measured. The findings were compared using paired T-test, Pearson correlation coefficient and Bland-Altman analysis.

Results: The average tonsillar physical measurements of length, width and height were 1.54 ± 0.28, 2.0 ± 0.31 cm and 2.72 ± 0.41 cm, and 1.73 ± 0.17, 1.61 ± 0.21 mm and 2.98 ± 0.28 mm from physical and 3DUS estimations, respectively (P < 0.001 for all measurements). The average tonsillar volume was 3.84 ± 1.23 ml and 4.30 ± 1.15 ml from physical and 3DUS measurements, respectively (p = 0.04). The Bland-Altman mean difference ± 95% limit of agreement between length, width, height, and volume results from the two measurements were -0.186 ± 2.01 cm, -0.393 ± 6.33 cm, 0.25 ± 7.71 cm, and 0.45 ± 2.32 ml, respectively.

Conclusion: While 3DUS is feasible, it may not be an accurate estimate of tonsillar volume for assessing hypertrophy. A larger study will be required to establish the accuracy of 3DUS measurements of tonsillar volume.
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http://dx.doi.org/10.1016/j.ijporl.2019.109612DOI Listing
November 2019

An evaluation of arytenoid prolapse following laryngotracheal reconstruction.

Laryngoscope 2020 01 5;130(1):247-251. Epub 2019 Mar 5.

Department of Otolaryngology, Children's National Health System, Washington, DC, U.S.A.

Objectives/hypothesis: Laryngotracheal reconstruction (LTR) is a collection of procedures used to treat pediatric laryngotracheal stenosis. Arytenoid prolapse is a potential postoperative complication that may lead to upper airway obstruction. This study investigates the incidence, risk factors, and need for surgical intervention for post-LTR arytenoid prolapse.

Study Design: Retrospective chart review.

Methods: The charts of 107 patients who underwent a total of 119 LTR procedures between 2005 and 2018 at a tertiary free-standing children's hospital were reviewed.

Results: The incidence of post-LTR arytenoid prolapse was 7.6%. Age, glottic involvement, tracheostomy status, vocal cord paralysis, and balloon dilation had no effect on arytenoid prolapse development. Sixteen percent of procedures performed in children <8 kg resulted in arytenoid prolapse, versus 4.5% of procedures performed in children >8 kg (P = .036). One hundred percent 100% of patients with post-LTR arytenoid prolapse had placement of a posterior graft. Multivariate analysis confirmed both weight <8 kg and posterior graft use to be significantly associated with arytenoid prolapse (P = .027 and .039, respectively). Three of the nine patients with arytenoid prolapse were symptomatic and weighed <8 kg at time of surgery. One required voice therapy; two required surgical intervention.

Conclusions: The incidence of arytenoid prolapse is 7.6% following LTR. Patients undergoing posterior graft LTR or weigh <8 kg at time of surgery are more likely to develop arytenoid prolapse. Children <8 kg at time of surgery who develop arytenoid prolapse are more likely to be symptomatic and require further intervention. These findings are valuable for preoperative risk assessment of pediatric laryngotracheal stenosis management.

Level Of Evidence: 4 Laryngoscope, 130:247-251, 2020.
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http://dx.doi.org/10.1002/lary.27864DOI Listing
January 2020

Special Populations in Implantable Auditory Devices: Pediatric.

Otolaryngol Clin North Am 2019 Apr;52(2):323-330

Division of Pediatric Otolaryngology, Children's National Health System, George Washington University School of Medicine, 111 Michigan Avenue Northwest, Washington, DC 20010, USA. Electronic address:

"Hearing loss in the pediatric population can have significant social and developmental implications. Early auditory rehabilitation by at least 6 months of age is imperative. Although traditional hearing aids are often a first-line treatment option, there is a wide array of implantable auditory devices available. This article describes the indications for such devices as they pertain to the pediatric population, including osseointegrated bone-conduction devices, middle ear implants, cochlear implants, and auditory brainstem implants."
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http://dx.doi.org/10.1016/j.otc.2018.11.015DOI Listing
April 2019

Outcome measures for pediatric laryngotracheal reconstruction: International consensus statement.

Laryngoscope 2019 01 27;129(1):244-255. Epub 2018 Aug 27.

University of Arkansas School for Medical Sciences, Department of Otolaryngology-Head & Neck Surgery, Arkansas Children's Hospital, Little Rock, Arkansas.

Objectives: Develop multidisciplinary and international consensus on patient, disease, procedural, and perioperative factors, as well as key outcome measures and complications, to be reported for pediatric airway reconstruction studies.

Methods: Standard Delphi methods were applied. Participants proposed items in three categories: 1) patient/disease characteristics, 2) procedural/intraoperative/perioperative factors, and 3) outcome measures and complications. Both general and anatomic site-specific measures were elicited. Participants also suggested specific operations to be encompassed by this project. We then used iterative ranking and review to develop consensus lists via a priori Delphi consensus criteria.

Results: Thirty-three pediatric airway experts from eight countries in North and South America, Europe, and Australia participated, representing otolaryngology (including International Pediatric Otolaryngology Group members), pulmonology, general surgery, and cardiothoracic surgery. Consensus led to inclusion of 19 operations comprising open expansion, resection, and slide procedures of the larynx, trachea, and bronchi as well as three endoscopic procedures. Consensus was achieved on multiple patient/comorbidity (10), disease/stenosis (7), perioperative-/intraoperative-/procedure-related (16) factors. Consensus was reached on multiple outcome and complication measures, both general and site-specific (8 general, 13 supraglottic, 15 glottic, 17 subglottic, 8 cervical tracheal, 12 thoracic tracheal). The group was able to clarify how each outcome should be measured, with specific instruments defined where applicable.

Conclusion: This consensus statement provides a framework to communicate results consistently and reproducibly, facilitating meta-analyses, quality improvement, transfer of information, and surgeon self-assessment. It also clarifies expert opinion on which patient, disease, procedural, and outcome measures may be important to consider in any pediatric airway reconstruction patient.

Level Of Evidence: 5 Laryngoscope, 129:244-255, 2019.
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http://dx.doi.org/10.1002/lary.27445DOI Listing
January 2019