Considering a Weight Criterion for Neonatal Tracheostomy: An Analysis of the ACS NSQIP-P.

OBJECTIVES: Neonates weighing < 2.5 kg have known higher rates of surgical mortality and morbidity, but this remains unexamined specifically for tracheostomy. We present outcomes of neonates undergoing tracheostomy stratified by weight. METHODS: Retrospective review of the American College of Surgeons National Surgical Quality Improvement Program-Pediatric from 2012 to 2014. Patients undergoing tracheostomy were included. Thirty-day mortality and major/minor complication rates were stratified by weight (group 1: < 2.5 kg; group 2: ≥ 2.5 kg and < 4 kg; group 3: ≥ 4 kg). Patient comorbidities were assessed for independent risk factors of morbidity and mortality. RESULTS: Of 183,233 patients, 543 underwent tracheostomy. Forty-four patients were group 1 (mean: 2.2 kg ± 0.25); 170 patients were group 2 (mean: 3.31 kg ± 0.42); and 329 patients were group 3 (mean: 6.4 kg ± 2.7). Between groups 1 and 2, there were no significant differences in mortality (P = 0.47), major complication rates (P = 0.99), or minor complication rates (P = 0.64). In comparing all three groups, there were no significant differences in mortality (P = 0.47), major complication rates (P = 0.80), or minor complication rates (P = 0.77). The overall 30-day mortality for all patients was 4.24%. In a multivariate logistical regression model, weight group did not change the odds of all negative outcomes (group 1: odds ratio [OR] of 0.71; 95% confidence interval [CI], 0.33-1.53 and group 2: OR of 0.78; 95% CI, 0.50-1.22). Bronchopulmonary dysplasia was the only independent significant predictor of major complications (OR, 1.69; 95% CI, 1.02-2.79) (P = 0.04). CONCLUSION: Our data indicate that 30-day mortality and morbidity outcomes for neonatal tracheostomy are not affected by weight. Overall 30-day mortality should be discussed with caregivers preoperatively. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:500-505, 2019.

Sex bias in basic science and translational otolaryngology research.

OBJECTIVES/HYPOTHESIS: Recent studies revealed sex bias in surgical research. Although many diseases exhibit sex-based clinically relevant differences, otolaryngology research has not been evaluated for sex reporting and sex-based analysis. We postulate that a similar bias is prevalent in otolaryngology literature. STUDY DESIGN: Literature review. METHODS: Articles published from 2016 to 2017 in The Laryngoscope, Otolaryngology-Head and Neck Surgery, and JAMA Otolaryngology-Head and Neck Surgery were reviewed. Articles with animal subjects, human subject cells, or commercial cell lines were included. Data collected included study type, cell/animal sex, and sex-based data analysis. RESULTS: One hundred forty-four basic/translational research articles were identified. Sixty-nine (47.9%) of those lacked sex reporting. Of 75 studies that reported sex, 22 (29.3%) included both sexes, and 11 (14.7%) analyzed data by sex. One hundred five (72.9%) used animal subjects, of which 54 (51.9%) lacked sex breakdown. Among animal studies, 48/105 included only one sex, and three articles analyzed data by sex. Fifty-four studies used commercial cell lines (N = 23) or human/animal subject cells (N = 31). Among cell groups, 28/54 (51.9%) were of unknown sex, and seven were single sex. Eight (14.8%) studies included data analysis by sex. Domestic studies exhibited a lower rate of sex reporting in both animal and cell studies, and a lower rate of sex-based analysis in cell studies. CONCLUSIONS: Sex may influence outcomes significantly but is underreported and underanalyzed in basic/translational otolaryngology research. Because this research frequently lays the groundwork for clinical trials and standards of care, future research must address these sex-based discrepancies. LEVEL OF EVIDENCE: NA Laryngoscope, 129:613-618, 2019.

Sex bias: Is it pervasive in otolaryngology clinical research?

OBJECTIVES/HYPOTHESIS: Recent initiatives highlight substantial sex bias in biomedical research. The objective was to determine whether sex bias is present in otolaryngology and whether sex is appropriately analyzed as an independent variable in otolaryngology clinical research. STUDY DESIGN: Literature review. METHODS: We systematically reviewed all 2016 articles in three major otolaryngology journals: The Laryngoscope, JAMA Otolaryngology-Head and Neck Surgery, and Otolaryngology-Head and Neck Surgery. Extracted data included study origin, location, subspecialty, number/sex of subjects, ≥50% sex matching (SM≥50 ), and sex-based statistical analysis. RESULTS: Six hundred of 1,209 articles comprising original clinical research were reviewed including 8,997,345,495 subjects (males: 3,898,559,264 [43.3%]; females: 5,095,592,583 [56.6%]; and unknown: 3,193,648 [0.04%]). There were 533/600 (88.8%) studies that included both sexes, eight (1.3%) included females only, five (0.8%) included males only, and 56 (9.3%) did not document participant sex. Only 280 studies (46.7%) analyzed data by sex, and 330 studies (60.7%) had SM≥50 . Sex-based statistical analysis and SM≥50 were similar in domestic and international studies (48.7% vs. 42.8% and 60.9% vs. 62%, respectively). Database studies performed sex-based statistical analysis more frequently than single and multi-institutional studies (79.1% vs. 40.4% and 43.4%, P < .00001). Analysis by sex was more frequently performed in head and neck surgery (53.6%) and pediatric otolaryngology (51.3%), whereas SM≥50 was highest in pediatric otolaryngology (86.8%) and otology (82.4%). CONCLUSIONS: Sex bias exists in the clinical otolaryngology literature, with less than half the studies analyzing sex. Acknowledging the intertwinement of sex with disease pathophysiology and outcomes is important. Eliminating sex bias in research and clinical care should become a major focus for otolaryngologists. LEVEL OF EVIDENCE: NA Laryngoscope, 129:858-864, 2019.

Cleft Lip and Palate.

Orofacial clefts are common congenital malformations with genetic and environmental risk factors. In the perinatal period, feeding and nutrition can be a challenge and the need for specialized feeders is common. Lip taping and nasoalveolar molding are early interventions that can be used to preoperatively modify cleft defects to enhance surgical outcomes. Multiple techniques are available for repair of orofacial clefts and choice of technique depends on cleft extent and surgeon preference. After definitive repair, children remain at increased risk for middle ear disease, velopharyngeal dysfunction, and malocclusion and require ongoing follow-up with a multidisciplinary team.

Surgical simulation and applicant perception in otolaryngology residency interviews.

OBJECTIVE: The traditional resident applicant interview involves multiple oral interviews. The implementation of surgical simulations adds an additional dimension of assessment but can be perceived in a stressful way by applicants. The purpose of this project is to describe low-fidelity simulations that were implemented for the 2016 to 2017 residency interviews and obtain applicant perception of these simulations. METHODS: Six simulation modules were created, which reflected tasks used in six subspecialties within otolaryngology (pediatrics, otology, laryngology, facial plastics, rhinology, and head/neck). Applicants were guided in the procedures by both an attending and resident. Afterward, applicants were anonymously surveyed on their perception of the tasks using a 5-point Likert scale (1 = Strongly Disagree, 2 = Somewhat Disagree, 3 = Neutral, 4 = Somewhat Agree, 5 = Strongly Agree). RESULTS: A total of 41 applicants were interviewed. The following were measured: enjoyable (98.5% strongly agree, 2.5% somewhat agree; mean: 4.97; 95% confidence interval [CI], 4.92, 5.02), educational (88% strongly agree, 12% somewhat agree; mean: 4.88; 95% CI, 4.78, 4.98), recommended for future use (92.7% strongly agree, 7.3% somewhat agree; mean: 4.93; 95% CI, 4.85, 5.01), and stressful (63.5% strongly disagree, 19.5% somewhat disagree, 17% neutral; mean: 1.54; 95% CI, 1.30, 1.78). CONCLUSION: Implementation of a low-fidelity multi-station surgical simulation experience is feasible in an interview day. Majority of applicants viewed the simulations in a positive manner. Surgical simulations may provide a useful holistic evaluation of an applicant in future interviews, especially if done in a setting that minimizes stress and maximizes the educational experience. LEVEL OF EVIDENCE: 2b. Laryngoscope, 2503-2507, 2018.

Trends in medical malpractice claims in patients with cleft or craniofacial abnormalities in the United States.

OBJECTIVE: To describe medical malpractice trends in patients with cleft and/or craniofacial abnormalities. METHODS AND MATERIALS: A modified Delphi approach was used to gather search terms. Search settings included "all jury verdicts and settlements", with jurisdiction of "all states" and "all federal courts" (by court and circuit). A retrospective review of WestLawNext legal database was conducted. Cases were excluded if they did not have a direct association from the patient's craniofacial anomaly or if they were not related to malpractice. RESULTS: Forty-two cases met inclusion criteria. Cases closed between 1981 and 2014 were included. The mean payment among claims with an indemnity payment was $3.9 million. Of cases brought to trial, 62% were in favor of the plaintiff. Amongst physicians named as co-defendants, pediatricians were most commonly named (24%), followed by plastic surgeons (16%), obstetricians (7.8%), and radiologists (7.8%). "Missed diagnosis" was the most common type of negligent claim (45%), followed by "surgical error" (21%), and "medication error" (17%). "Anoxic brain injury" resulted in the highest median indemnity payment for complication of patient management ($3.5 million), followed by "wrongful birth" ($1.03 million), and "minor physical injury" ($520,000). No specific type of negligent claim (p = 0.764) nor complication of patient management (p = 0.61) was associated with a greater indemnity payment. Mean indemnity payment was $920,000 prior to 2001 and $4.4 million after 2001 (p = 0.058). CONCLUSIONS: Mean indemnity payments were fourteen-fold greater in patients as compared to those in the overall population ($3.9 million versus $274,887) and seven-fold greater than those in the average pediatric population ($3.9 million versus $520,923). All healthcare providers should be aware of the associated medical malpractice claims that may be incurred when treating patients at risk for these conditions.

Diagnosis and management of patients with clefts: a comprehensive and interdisciplinary approach.

This article reviews the most current practice guidelines in the diagnosis and management of patients born with cleft lip and/or palate. Such patients frequently have multiple medical and social issues that benefit greatly from a team approach. Common challenges include feeding difficulty, nutritional deficiency, speech disorders, hearing problems, ear disease, dental anomalies, and both social and developmental delays, among others. Interdisciplinary evaluation and collaboration throughout a patient's development are essential.

Prospective quality of life assessment in congenital laryngomalacia.

PURPOSE OF STUDY: Disturbances in breathing or feeding may profoundly affect parental perceptions of a newborn's health. Previous research into quality of life for patients with laryngomalacia is limited to retrospective analysis. The purpose of this study is to prospectively evaluate the quality of life of families of infants with laryngomalacia and the impact of surgical and non-surgical treatments. DESIGN AND METHOD: Pilot prospective analysis using the laryngomalacia quality of life (QOL) survey in families of infants with newly diagnosed laryngomalacia under age one year. A 29-question survey regarding severity of symptoms related to overall health, airway, and swallowing is completed at initial and post-treatment visits. Responses are quantified over a range from 1 to 5 (1 never to 5 always). RESULTS: Twenty-six families were enrolled in the study. Eleven patients were managed medically and fifteen underwent supraglottoplasty. The overall mean QOL score for patients treated medically was 2.57 (standard error, SE 0.16) on initial visit and 1.67 (SE 0.16) post-treatment (mean 3.9 months). Patients undergoing supraglottoplasty had an overall mean QOL score of 3.59 (SE 0.14) on initial visit and 2.22 (SE 0.22) post-treatment (mean 3.5 months). Analysis of variance (ANOVA) and post hoc testing revealed significant improvement between initial and follow-up visits in both treatment groups (p < 0.01). Patients who underwent supraglottoplasty had significantly higher scores at initial visit (p < 0.01). No statistically significant difference was noted between patient groups post-treatment (p > 0.05). CONCLUSIONS: Prospective QOL assessment of children with laryngomalacia and their families reveals a significant burden of disease. Quality of life improves in all patients but may improve more significantly in patients managed surgically.

CT measured normative cartilage growth in children requiring costochondral grafting.

OBJECTIVE: Careful operative timing is required for children undergoing microtia repair using autologous costochondral grafting. This operation is performed as early as age 6 in efforts to treat children before school matriculation while allowing for sufficient rib growth. There remains a paucity of data regarding cartilaginous growth of the ribs and synchondrosis routinely harvested during microtia repair. This study employs CT imaging to generate normative costochondral growth characteristics in children. STUDY DESIGN: A population-based study was performed. SETTING: Tertiary care children's hospital. SUBJECTS AND METHODS: Chest CTs were reviewed in 360 children ages 3 to 20 years. Measurements included: length of ribs 6, 7, and 8 and the height and width of the synchondrosis between ribs 6 and 7. Growth charts are presented for gender and laterality. RESULTS: At age 6: ribs 6, 7, and 8 measure 5.96 ± 0.69, 7.79 ± 0.84, and 6.33 ± 1.01 cm, respectively. In adulthood the mean length of ribs 6, 7, and 8 are 8.29 ± 1.00, 11.10 ± 1.19, and 8.95 ± 1.99 cm, respectively. The vertical height of the synchondrosis at years 6 and 20 are 2.42 ± 0.39 and 3.59 ± 0.53 cm, respectively. Ribs 6, 7, and 8 as well as the synchondrosis grow in a nearly linear fashion. CONCLUSIONS: Cartilaginous growth of ribs 6 to 8 during early childhood is nearly linear. Synchondrosis height approaches adult auricle width at 8 years. Rib size is consistently larger in males and on the left side. These data are useful for the pediatric otolaryngologist and facial plastics and reconstructive surgeon performing microtia surgery.

Role of stromal cell-derived factor-1 expression in the injured mouse auditory nerve.

OBJECTIVE: The degeneration of hair cells and spiral ganglion neurons (SGNs) is an important pathologic process in the development of sensorineural hearing loss. In a murine model, predictable and reproducible damage to SGNs occurs through the application of ouabain to the round window. Recent evidence has shown that the chemokine stromal cell-derived factor-1 (SDF-1) is a potent chemoattractant of hematopoietic stem cells (HSCs) and provides trophic support to injured tissues during development and maturation. The hypothesis for the current study is that expression of SDF-1 plays an important role in protecting SGNs and preventing further degeneration in the setting of cochlear injury. STUDY DESIGN: Prospective, controlled. SETTING: Academic research laboratory. SUBJECT AND METHODS: Auditory brainstem response (ABR) and the expression of SDF-1 mRNA and protein were examined 1, 3, 7, 14, and 30 days after application of ouabain in 35 adult mice. RESULTS: Following ouabain application, real-time reverse-transcription polymerase chain reaction for SDF demonstrates increased mRNA expression following ouabain injury in nontransplanted mice. A significant increase in SDF protein expression was also observed using immunolabeling techniques and Western blot analysis. CONCLUSIONS: SDF-1 expression is increased in the auditory nerve following cochlear injury. Further knowledge about the cochlear microenvironment, including SDF-1, is critical to maximizing HSC engraftment in the injured cochlea and providing a therapeutic option for sensorineural hearing loss.

Sox2 up-regulation and glial cell proliferation following degeneration of spiral ganglion neurons in the adult mouse inner ear.

In the present study, glial cell responses to spiral ganglion neuron (SGN) degeneration were evaluated using a murine model of auditory neuropathy. Ouabain, a well-known Na,K-ATPase inhibitor, has been shown to induce SGN degeneration while sparing hair cell function. In addition to selectively removing type I SGNs, ouabain leads to hyperplasia and hypertrophy of glia-like cells in the injured auditory nerves. As the transcription factor Sox2 is predominantly expressed in proliferating and undifferentiated neural precursors during neurogenesis,we sought to examine Sox2 expression patterns following SGN injury by ouabain. Real-time RT-PCR and Western blot analyses of cochlea indicated a significant increase in Sox2 expression by 3 days posttreatment with ouabain. Cells incorporating bromodeoxyuridine(BrdU) and expressing Sox2 were counted in the auditory nerves of control and ouabain-treated ears. The glial phenotype of Sox2+cells was identified by two neural glial markers: S100 and Sox10. The number of Sox2+ glial cells significantly increased at 3 days post-treatment and reached its maximum level at 7 days post-treatment. Similarly,the number of BrdU+ cells increased at 3 and 7 days post-treatment in the injured nerves. Quantitative analysis with dual-immunostaining procedures indicated that about 70% of BrdU+ cells in the injured nerves were Sox2+ glial cells. These results demonstrate that up-regulation of Sox2 expression is associated with increased cell proliferation in the auditory nerve after injury.

Unmyelinated auditory type I spiral ganglion neurons in congenic Ly5.1 mice.

With the exception of humans, the somata of type I spiral ganglion neurons (SGNs) of most mammalian species are heavily myelinated. In an earlier study, we used Ly5.1 congenic mice as transplant recipients to investigate the role of hematopoietic stem cells in the adult mouse inner ear. An unanticipated finding was that a large percentage of the SGNs in this strain were unmyelinated. Further characterization of the auditory phenotype of young adult Ly5.1 mice in the present study revealed several unusual characteristics, including 1) large aggregates of unmyelinated SGNs in the apical and middle turns, 2) symmetrical junction-like contacts between the unmyelinated neurons, 3) abnormal expression patterns for CNPase and connexin 29 in the SGN clusters, 4) reduced SGN density in the basal cochlea without a corresponding loss of sensory hair cells, 5) significantly delayed auditory brainstem response (ABR) wave I latencies at low and middle frequencies compared with control mice with similar ABR threshold, and 6) elevated ABR thresholds and deceased wave I amplitudes at high frequencies. Taken together, these data suggest a defect in Schwann cells that leads to incomplete myelinization of SGNs during cochlear development. The Ly5.1 mouse strain appears to be the only rodent model so far identified with a high degree of the "human-like" feature of unmyelinated SGNs that aggregate into neural clusters. Thus, this strain may provide a suitable animal platform for modeling human auditory information processing such as synchronous neural activity and other auditory response properties.

Postoperative management following sphincter pharyngoplasty.

OBJECTIVE: To evaluate postoperative airway-associated outcomes following sphincter pharyngoplasty. STUDY DESIGN: Case series with chart review. SETTING: Academic tertiary care medical center. SUBJECTS AND METHODS: Postoperative management of sphincter pharyngoplasty (SP) conventionally includes overnight observation to monitor for upper airway obstruction. To evaluate for postoperative airway-related outcomes, 36 patients who underwent SP between April 2003 and January 2009 were evaluated retrospectively. RESULTS: Mean patient age was 8.1 (SD 4.3) years. Mean follow-up was 6.5 (SD 10.7) months. Cleft palate (36.1%), velo-cardio-facial syndrome (22.2%), and post-adenoidectomy (16.7%) were the most common causes of velopharyngeal insufficiency. All patients underwent overnight observation postoperatively. Mean hospital stay was 1.2 (SD 0.5) days. Five patients remained inpatient two or three days owing to fever (2 patients), bleeding ear after concurrent otoplasty (1 patient), minimal oropharyngeal bleeding with spontaneous resolution (1 patient), and medication allergy (1 patient). No patient had a documented apneic event or desaturation below 95 percent. Although no desaturations were documented, four patients received supplemental oxygen: three for less than two hours, and one for 12 hours. All patients had adequate oral intake and pain control on oral medications prior to discharge; nine patients required one to three doses of intravenous narcotic medication for pain on postoperative day zero. CONCLUSION: Upper airway obstruction requiring overnight observation following SP is uncommon. In otherwise healthy patients, performing SP in an outpatient setting, given appropriate recovery room evaluation for airway concerns, oral intake, and pain control, should be considered.

Use of sentinel lymph node biopsy for melanoma of the head and neck.

Sentinel lymph node biopsy (SLN) is a well-accepted procedure for truncal and extremity melanoma (T&E). However, its role in melanoma of the head and neck (H&N) remains controversial. Complex lymphatic and vascular drainage make SLN more challenging in this region. This study was done to evaluate the results of SLN for H&N versus T&E melanoma. Three hundred sixteen patients who underwent SLN for melanoma using a double indicator technique were identified from a prospective database. Records were analyzed retrospectively. Statistical analysis was performed using chi2, t test, or Mann-Whitney U test to evaluate the results, as appropriate. H&N was found in 87 cases (27.5%). The mean age was 63.2 and 53.2 years for H&N and T&E melanoma (P < 0.001), respectively. 99Technetium positivity (89.7% H&N versus 99.6% T&E, P < 0.001) and isosulfan blue positivity (85.1% H&N versus 91.7% T&E, P = 0.08) were more likely in T&E melanoma. There was a significant difference between H&N and T&E melanoma with respect to the incidence of failed SLN, defined as no sentinel nodes identified intraoperatively (8.0% versus 0%, P < 0.001). Both groups had similar rates of positive intraoperative imprint cytologic examination (4.6% H&N versus 6.1% T&E, P > 0.5). There was a trend suggesting a higher mean number of sentinel lymph nodes found (3.1 versus 2.7, P = 0.1) in H&N melanoma. The total number of lymph nodes found in dissection specimens (20.9 versus 21.9, P = 0.45), the total number of positive lymph nodes (3.5 versus 1.6, P = 0.32), the incidence of any recurrence (19.5% versus 12.7%, P = 0.2), and time to recurrence (14.2 versus 20.6 months, P = 0.18) were similar between H&N and T&E melanoma. SLN mapping of H&N lesions is more difficult than at other sites. However, rates of nodal positivity are similar to melanoma of the trunk and extremities. Therefore, despite being more demanding, SLN is useful in diagnosis and treatment of melanomas of the head and neck.

Office-based laryngeal laser surgery: a review of 443 cases using three wavelengths.

BACKGROUND: Unsedated office-based laser surgery (UOLS) of the larynx and trachea has significantly improved the treatment options for patients with laryngotracheal pathology including recurrent respiratory papillomas, granulomas, leukoplakia, and polypoid degeneration. UOLS delivered by flexible endoscopes has dramatically impacted office-based surgery by reducing the time, costs, and morbidity of surgery. OBJECTIVES: To review our experience with 443 laryngotracheal cases treated by UOLS. METHODS: The laser logbooks at the Center for Voice and Swallowing Disorders were reviewed for UOLS, and the medical and laryngological histories were detailed, as were the treatment modalities, frequencies, and complications. RESULTS: Of the 443 cases, 406 were performed with the pulsed-dye laser, 10 with the carbon-dioxide laser, and 27 with the thulium: yttrium-aluminum-garnet laser. There were no significant complications in this series. A review of indications and wavelength selection criteria is presented. CONCLUSION: Unsedated, office-based, upper aerodigestive tract laser surgery appears to be a safe and effective treatment option for many patients with laryngotracheal pathology.