Microsecretory Adenocarcinoma of the Ear Canal: Novel Cutaneous Analog of a Salivary Gland Neoplasm.

ABSTRACT: Microsecretory adenocarcinoma (MSA) of the salivary gland is a new entity recently added to the World Health Organization Classification of Head and Neck Tumors. This tumor is characterized by a recurrent MEF2C-SS18 translocation. We present a nodular tumor confined to the dermis of the ear canal of a 44-year-old patient, which demonstrated classic histopathologic features and molecular alteration of MSA. Specifically, the tumor was composed of numerous tubules and microcysts filled with abundant basophilic mucinous secretion and associated with a fibromyxoid stroma. The tumor cells were diffusely positive for CK7 and SOX10 and variably positive for S100 and p63. Breakapart fluorescence in situ hybridization for SS18 confirmed rearrangement of this gene. Together, these findings support a primary cutaneous MSA, presumably arising from ceruminous glands of the ear canal. Based on current knowledge of its salivary gland counterpart, cutaneous MSA is expected to be locally invasive but unlikely to recur or metastasize on complete excision.

A Novel Performance-Based Paradigm of Care for Cochlear Implant Follow-Up.

OBJECTIVES: Utilize a multi-institutional outcomes database to determine expected performance for adult cochlear implant (CI) users. Estimate the percentage of patients who are high performers and achieve performance plateau. STUDY DESIGN: Retrospective database study. METHODS: Outcomes from 9,448 implantations were mined to identify 804 adult, unilateral recipients who had one preoperative and at least one postoperative consonant-nucleus-consonant (CNC) word score. Results were examined to determine percent-correct CNC word recognition preoperatively and at 1, 3, 6, 12, and 24 months after activation. Outcomes from 318 similar patients who also had at least three postoperative CNC word scores were examined. Linear mixed-effects regression was used to examine CNC word performance over time. The time when each patient achieved maximum performance was recorded as a surrogate for time of performance plateau. Patients were assigned as candidates for less intense follow-up if they were high performers and achieved performance plateau. RESULTS: Among 804 patients with at least one postoperative score, CNC score improved at all time intervals. Average performance after the 3-month time interval was 47.2% to 51.5%, indicating a CNC ≥ 50% cutoff for high performers. Among 318 patients with at least three postoperative scores, performance improved from 1 to 3 (P = .001), 3 to 6 (P = .001), and 6 to 12 (P = .01) months. Scores from the 12- and 24-month intervals did not significantly differ (P = .09). By 12 months after activation, 59.7% of patients were considered candidates for less intense follow-up. CONCLUSION: Findings suggest that CNC ≥ 50% is a reasonable cutoff to separate high performers from low performers. Within 12 months after activation, 59.7% of patients were good candidates for less intense follow-up. LEVEL OF EVIDENCE: 3 Laryngoscope, 132:S1-S10, 2022.

Real-World Compliance With Follow-up in 2,554 Cochlear Implant Recipients: An Analysis of the HERMES Database.

BACKGROUND: Traditional paradigms of care recommend close audiology follow-up and regular speech perception outcomes assessment indefinitely for cochlear implant (CI) recipients after device activation. However, there is scant published data on actual compliance with this paradigm in clinical practice. METHODS: A multi-center cochlear implant database was queried to identify follow-up rates after cochlear implantation. Follow-up rates where speech perception outcomes assessment occurred at 1-, 3-, 6-, 12-, 18-, and 24-months post-activation were determined by tabulating observed follow-up divided by expected follow-up (O/E ratio) expressed as a percentage. To determine all-cause audiology follow-up rates (with or without testing speech perception outcomes assessment), the database patients from two participating centers (one private practice and one academic center) were similarly analyzed using electronic health record (EHR) data to calculate O/E rates where audiology follow-up occurred for any reason. RESULTS: O/E follow-up rates where speech perception outcomes assessment occurred was 42, 40, 31, 29, 5, and 22% for 1-, 3-, 6-, 12-, 18-, and 24-months post-activation, respectively (n = 2,554). All-cause audiology follow-up rates (with or without speech perception outcomes assessment) using EHR-confirmed data from two individual centers were 97, 94, 81, 66, 41, and 35% at 1-, 3-, 6-, 12-, 18-, and 24-months post-activation visits, respectively (n = 118). CONCLUSIONS: Compliance with audiology follow-up and speech perception outcomes assessment is generally low and decreases significantly as time post-activation increases. Future paradigms of care for CI should be designed recognizing the significant attrition that occurs with CI follow-up.

Benefits of a Hearing Registry: Cochlear Implant Candidacy in Quiet Versus Noise in 1,611 Patients.

Purpose This retrospective study used a cochlear implant registry to determine how performing speech recognition candidacy testing in quiet versus noise influenced patient selection, speech recognition, and self-report outcomes. Method Database queries identified 1,611 cochlear implant recipients who were divided into three implant candidacy qualifying groups based on preoperative speech perception scores (≤ 40% correct) on the AzBio sentence test: quiet qualifying group, +10 dB SNR qualifying group, and +5 dB SNR qualifying group. These groups were evaluated for demographic and preoperative hearing characteristics. Repeated-measures analysis of variance was used to compare pre- and postoperative performance on the AzBio in quiet and noise with qualifying group as a between-subjects factor. For a subset of recipients, pre- to postoperative changes on the Speech, Spatial and Qualities of Hearing Scale were also evaluated. Results Of the 1,611 patients identified as cochlear implant candidates, 63% of recipients qualified in quiet, 10% qualified in a +10 dB SNR, and 27% qualified in a +5 dB SNR. Postoperative speech perception scores in quiet and noise significantly improved for all qualifying groups. Across qualifying groups, the greatest speech perception improvements were observed when tested in the same qualifying listening condition. For a subset of patients, the total Speech, Spatial and Qualities of Hearing Scale ratings improved significantly as well. Conclusion Patients who qualified for cochlear implantation in quiet or background noise test conditions showed significant improvement in speech perception and quality of life scores, especially when the qualifying noise condition was used to track performance.

Assessing Cochlear Implant Performance in Older Adults Using a Single, Universal Outcome Measure Created With Imputation in HERMES.

OBJECTIVE: In the era of big data, it is critical to aggregate results across different institutions. This is a major challenge for cochlear implant (CI) research given multiple, incompatible outcome measures. We use a large, national CI database to develop a formula to convert between the two most common measures: Consonant-Nucleus-Consonant word (CNCw) and Arizona Biomedical (AzBio). We then use this tool to analyze hearing outcomes in older adults with a single, universal outcome measure. STUDY DESIGN: Analysis of a prospective, national cochlear implant database (HERMES). SETTING: Multicentered, 32 US private practice and academic medical centers. PATIENTS: CI subjects (n = 386, n = 430 ears; 10-102 years old; mean: 65). MAIN OUTCOME MEASURE(S): CNCw, AzBio. RESULTS: Univariable linear regression equations were generated relating CNCw and AzBio scores at each time-point. Correlation (R) was 0.71 (3 mo), 0.69 (6 mo), 0.63 (12 mo), and 0.56 (24 mo) (all p < 0.01). Using these equations, missing outcomes (CNCw, n = 83 or AZBio, n = 96) were imputed (calculated). The average absolute difference between observed and imputed CNCw (when both present) was 10.5% (95% CI = 9.8-11.3). On multivariable regression, age was not a significant predictor of CNCw (p = 0.38) after controlling for sex, hearing loss duration, use, and postoperative follow-up duration. CONCLUSIONS: We generated simple linear regression equations to calculate CNCw scores from AzBio, and vice versa, with good accuracy. This allowed one of the largest analyses of CI performance in older adults to date. We confirm that older age is not a significant predictor of performance when controlling for confounders.

Pilot study on the use of data mining to identify cochlear implant candidates.

OBJECTIVES: The goal of this pilot study was to determine the clinical utility of data-mining software that screens for cochlear implant (CI) candidacy. METHODS: The Auditory Implant Initiative developed a software module that screens for CI candidates via integration with a software system (Noah 4) that serves as a depository for hearing test data. To identify candidates, patient audiograms from one practice were exported into the screening module. Candidates were tracked to determine if any eventually underwent implantation. RESULTS: After loading 4836 audiograms from the Noah 4 system, the screening module identified 558 potential CI candidates. After reviewing the data for the potential candidates, 117 were targeted and invited to an educational event. Following the event, a total of six candidates were evaluated, and two were implanted. DISCUSSION: This objective approach to identifying candidates has the potential to address the gross underutilization of CIs by removing any bias or lack of knowledge regarding the management of severe to profound sensorineural hearing loss with CIs. CONCLUSION: The screening module was an effective tool for identifying potential CI candidates at one ENT practice. On a larger scale, the screening module has the potential to impact thousands of CI candidates worldwide.

Assessing Cochlear Implant Outcomes in Older Adults Using HERMES: A National Web-based Database.

OBJECTIVE: Cochlear implant (CI) outcomes research has been largely limited to retrospective or single-institution studies in the United States. The objective is to demonstrate the feasibility of using a novel, national, web-based CI database through evaluating CI outcomes in older adults. STUDY DESIGN: Analysis of a prospective, national, web-based database designed for CI outcome tracking (HERMES; HIPAA-secure, Encrypted, Research Management and Evaluation Solution). SETTING: Multi-centered at 18 private practice and academic US medical centers. PATIENTS: Older (age ≥75, n = 47) or younger (age <75, n = 103) adult CI patients (n = 150 total, n = 160 ears). MAIN OUTCOME MEASURE(S): Arizona Biomedical (AzBio), CI usage, postoperative complications. RESULTS: Older adults had slightly lower performance on most recent AzBio (56.0%, n = 26, 12.2 ±â€Š6.5 mo postoperatively) compared with younger adults (74.0%, n = 52, 12.6 ±â€Š6.5 mo postoperatively; p < 0.01, Mann-Whitney). However, on multiple regression, age was not a significant predictor of AzBio scores after controlling for sex, hearing loss duration, use, and postoperative follow-up duration. Most recent CI use was similar but significantly different (11.4 h/d in older, n = 24 versus 13.0 in younger, n = 45; p = 0.01). Usage also did not decline over time (p = 0.81 in older versus p = 0.46, in younger). The most common complications were similar (vertigo 25 versus 20%, p = 0.45; tinnitus 4 versus 4%, p = 0.93) in older and younger adults, respectively. CONCLUSION: We demonstrate the feasibility of a novel user-friendly, web-based, national CI database to analyze CI outcomes. Older age was not a significant predictor of AzBio scores after adjusting for multiple factors. Additionally, CI use did not decline over time.

Creating a framework for data sharing in cochlear implant research.

OBJECTIVES: To summarize the development process of a national database that was designed to facilitate communication and collaboration, improve care, and create a framework for aggregate data sharing in cochlear implant (CI) research. METHODS: A group of nationally represented, multidisciplinary CI providers cooperated to define a standard set of data elements to incorporate into a database built by them in association with a group of computer scientists and software designers. CI centers across the USA, then, joined the non-profit Auditory Implant Initiative to use the database for their own clinical purposes and to help contribute to the national de-identified dataset for research and analytics. RESULTS: Approximately 12 months after the full release of the database, clinical information on 373 patients has been entered from 17 different CI centers representing 61 hearing professionals. A blend of six academic, seven private, and four non-profit CI centers participated in this phase of the data sharing network. DISCUSSION: The adoption of a single, standardized database by 17 centers throughout the USA has begun a framework for data sharing in CI research. Future steps include (1) expanding adoption, (2) scaling the database to include more patients, (3) streamlining the legal hurdles required for adoption, and (4) integrating the database with other software platforms (e.g. electronic health records, processors). CONCLUSION: A standardized clinical outcomes database that is utilized by a growing network of CI centers can help strengthen research through aggregate data sharing.

Steroids for improving recovery following tonsillectomy in children.

BACKGROUND: This is an update of a Cochrane Review first published in The Cochrane Library in Issue 1, 2003.Tonsillectomy continues to be one of the most common surgical procedures performed worldwide. Despite advances in anesthetic and surgical techniques, post-tonsillectomy morbidity remains a significant clinical problem. OBJECTIVES: To assess the clinical efficacy of a single intraoperative dose of dexamethasone in reducing post-tonsillectomy morbidity. SEARCH STRATEGY: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ISRCTN; and additional sources for published and unpublished trials. The date of the most recent search was 29 October 2010, following a previous search in September 2002. SELECTION CRITERIA: Randomized, double-blind, placebo-controlled trials of a single dose of intravenous, intraoperative corticosteroid for pediatric patients (age < 18 years) who underwent tonsillectomy or adenotonsillectomy. DATA COLLECTION AND ANALYSIS: The first author extracted data regarding the primary outcome measures and measurement tools from the published studies. The first author also recorded data regarding study design, patient ages, procedures performed, dose of corticosteroid and method of delivery, as well as methodological quality. When data were missing from the original publications, we contacted the authors for more information. We performed data analysis with a random-effects model, using the RevMan 5.1 software developed by the Cochrane Collaboration. MAIN RESULTS: We included 19 studies (1756 participants). We selected only randomized, placebo-controlled, double-blinded studies to minimize inclusion of poor quality studies. However, the risk of bias in the included studies was not formally assessed. Children receiving a single intraoperative dose of dexamethasone (dose range = 0.15 to 1.0 mg/kg) were half as likely to vomit in the first 24 hours compared to children receiving placebo (risk ratio (RR) 0.49; 95% confidence interval (CI) 0.41 to 0.58; P < 0.00001). Routine use in five children would be expected to result in one less patient experiencing post-tonsillectomy emesis (risk difference (RD) -0.24; 95% CI -0.32 to -0.15; P < 0.00001). Children receiving dexamethasone were also more likely to advance to a soft/solid diet on post-tonsillectomy day one (RR 1.45; 95% CI 1.15 to 1.83; P = 0.001) than those receiving placebo. Finally, postoperative pain was improved in children receiving dexamethasone as measured by a visual analog scale (VAS, 0 to 10) (MD -1.07; 95% CI -1.73 to -0.41; P = 0.001), which correlates clinically to a reduction in pain (on a VAS of 0 to 10) from 4.72 to 3.65. No adverse events were noted in the included studies. AUTHORS' CONCLUSIONS: The evidence suggests that a single intravenous dose of dexamethasone is an effective, safe and inexpensive treatment for reducing morbidity from pediatric tonsillectomy.

Clinical evaluation of a bioresorbable implant for medialization of the middle turbinate in sinus surgery.

BACKGROUND: During endoscopic sinus surgery (ESS), postoperative lateralization of the middle turbinate can lead to scarring and obstruction of key drainage pathways, including the osteomeatal complex. The technique of suturing the middle turbinate to the nasal septum to enhance exposure can be difficult and time consuming. This study presents the first clinical results using the Middle Turbinate Implant (MTI), a device composed of absorbable copolymer polylactide-co-glycolide and intended to medialize the middle turbinate during surgical procedures such as ESS. METHODS: The trial included 22 implantations (21 successful implantations) on 14 subjects (6 unilateral and 8 bilateral implantations). The primary outcome measure was the position of the middle turbinate at 1, 2, and 4 weeks postoperatively. The extent of tissue reaction at the site of implantation was also evaluated. RESULTS: At 1, 2, and 4 weeks postoperatively, 100% of the middle turbinates were held medially or in the neutral position with no significant synechiae present. At 1, 2, and 4 weeks postoperatively, there was either no (95%, 90%, and 95%) or mild (5%, 10%, and 5%) tissue reaction at the site of implantation. No complications were noted during implantation. CONCLUSION: The use of the bioresorbable MTI appears to be a safe and effective method of medializing the middle turbinate during ESS.

How does the absence or presence of subglottal medialization affect glottal airflow?

OBJECTIVES: Our previous work has shown that the symmetric, smooth, convergent shape of the subglottis reduces turbulent airflow at the glottal entrance. Medialization thyroplasty may alter the glottal shape and is very likely to introduce some degree of glottal asymmetry, which could result in increased turbulence and a reduction in voice quality. This study reports the effects of medializing and not medializing the subglottis in silicone models of human cadaveric larynges. METHODS: In experiment 1, silicone models of 4 human cadaveric larynges were created. The subglottis was then completely medialized in all 4 models. Hot-wire anemometry was used to measure velocity and turbulence profiles at the entrance and exit of the subglottis. In experiment 2, 1 model was created to accommodate incremental medialization of the glottis without any medialization of the subglottis. Airflow characteristics were likewise measured. RESULTS: In experiment 1, the average maximum turbulence intensity (TI) at the exit of the larynx was less than the TI of incoming tracheal airflow for all 4 larynges. In experiment 2, incremental medialization of the glottis did not affect the TI for medialization up to 35%. However, the TI significantly increased for medialization of 53%. CONCLUSIONS: Medialization of the subglottis does not significantly affect the turbulence reduction properties of the subglottis, even though subglottal asymmetry is introduced. On the other hand, large amounts of medialization of the glottis only (with no subglottal medialization) can introduce significant amounts of turbulence.

Comparing quality at an ambulatory surgery center and a hospital-based facility: preliminary findings.

OBJECTIVE: To measure the quality of outpatient surgery in an ambulatory surgery center (ASC) compared to a hospital-based facility (HBF) in a multidimensional manner. STUDY DESIGN: Cross-sectional survey based on chart review. SETTING: Pediatric academic health center. SUBJECTS AND METHODS: A total of 486 cases were reviewed. Procedures were performed at either an ASC (n = 275) or an HBF (n = 211). Cases comprised four procedure types: ventilation tube insertion (ASC, n = 126; HBF, n = 108), dental rehabilitation (ASC, n = 89; HBF, n = 58), adenotonsillectomy (ASC, n = 37; HBF, n = 34), and ventilation tube insertion/adenoidectomy (ASC, n = 23; HBF, n = 11). Measures were developed for five categories: safety, patient-centeredness, timeliness, efficiency, and equitability. Performance was compared between facilities. RESULTS: The ASC had no unexpected safety events (0/275) compared to nine events (9/211) at the HBF. Tonsil bleed rates were 0 percent (0/37) at the ASC compared to 5.9 percent (2/34) at the HBF. Patient satisfaction was similar between facilities (ASC, n = 64; HBF, n = 35). Differences in timeliness approached 30 percent. A total of 77 percent of ASC cases finished within the scheduled time compared to 38 percent at the HBF. Total charges were 12 to 23 percent less at the ASC. Patients treated at the ASC generally lived in wealthier neighborhoods. CONCLUSION: Performance at the ASC generally exceeded that at the HBF. Future research should investigate how perioperative processes result in these quality differences. Health policy implications are discussed.

Spontaneous nasal septal perforation with antiangiogenic bevacizumab therapy.

Otolaryngologists should be made aware of a newer cause of nasal septal perforations resulting from the more recent antiangiogenic therapy used to treat malignancies. This case describes a 52-year-old white woman who developed a spontaneous nasal septal perforation after given the antiangiogenic drug, bevacizumab, for metastatic ovarian cancer treatment. Bevacizumab is a recently developed monoclonal antibody against vascular endothelial growth factor receptor used to inhibit angiogenesis. The patient was ultimately treated with a nasal septal button with good symptom relief. This case documents the first report in the otolaryngology literature describing this new etiology for nasal septal perforations.

Acquired tracheoesophageal fistula following disc-battery ingestion: can we watch and wait?

Acquired tracheoesophageal fistulas (TEF) are rare but dangerous complications of disc-battery ingestion. Management approaches include endoscopic or open surgical repair. Unfortunately, these procedures can be complicated by high rates of recurrent laryngeal nerve injury, tracheal stenosis, recurrent fistula and significant patient mortality. Thus, several authors have advocated the use of esophageal rest as conservative management of acquired TEF to permit closure by secondary intention. This study describes a patient with spontaneous closure of an acquired TEF following disc-battery ingestion. The late recurrence of the TEF following conservative management, and endoscopic and radiographic evidence of closure, illustrates the importance of long term evaluation before assuming fistula resolution. Practitioners must carefully weigh the risks and benefits before deciding surgical versus conservative management of TEF. An extended follow-up of at least 6 months should be instituted with a high index of suspicion if conservative management is utilized. Transtracheal repair using an imbricated suture technique is a good surgical option when conservative management fails.

Patients' commitment to their primary physician and why it matters.

PURPOSE: The patient-physician relationship is the cornerstone of health care service delivery. The objectives of this study were to assess the contribution of relationship commitment along with trust to patient-physician relationships and to evaluate the association of commitment and trust with adherence to medical advice and healthy eating behaviors. METHODS: To test the proposed model, we developed a questionnaire that included both existing scales and a scale constructed specifically for the study; the questions addressed trust, commitment, adherence to physicians' medical recommendations, and healthy eating behavior. The questionnaire was given to adult patients in the waiting rooms of 4 large clinics in central Texas. RESULTS: A total of 1,008 patients returned questionnaires; 869 patients' questionnaires were complete and used in the analysis. A 3-stage least squares analysis that tested a system of 4 equations which included relationship commitment yielded a systemwide R(2) of 0.71 that was 0.09 higher than a system of equations excluding relationship commitment. Trust and commitment were positively associated with adherence (P <.001 and P = .02, respectively). We also found positive relationships between adherence and commitment and between trust and commitment (P <.001 for each). Adherence and commitment were both associated with healthy eating behavior as well (P <.001 for each). CONCLUSIONS: Patients' trust in their physician and commitment to the relationship offer a more complete understanding of the patient-physician relationship. In addition, trust and commitment favorably influence patients' health behaviors.

Neonatal alcohol exposure increases malondialdehyde (MDA) and glutathione (GSH) levels in the developing cerebellum.

It has been suggested that developmental alcohol-induced brain damage is mediated through increases in oxidative stress. In this study, the concentrations of malondialdehyde (MDA) and reduced glutathione (GSH) were measured to indicate alcohol-mediated oxidative stress. In addition, the ability of two known antioxidants, melatonin (MEL) and lazaroid U-83836E (U), to attenuate alcohol-induced oxidative stress was investigated. Sprague-Dawley rat pups were randomly assigned to six artificially-reared groups, ALC (alcohol), MEL, MEL/ALC, U, U/ALC, and GC (gastrostomy control), and one normal suckle control (to control for artificial-rearing effects on the dependent variables). The daily dosages for ALC, MEL, and U were 6 g/kg, 20 mg/kg, and 20 mg/kg, respectively. Alcohol was administered in 2 consecutive feedings, and antioxidant (MEL or U) was administered for a total of 4 consecutive feedings (2 feedings prior to and 2 feedings concurrently with alcohol). The animals received treatment from postnatal days (PD) 4 through 9. Cerebellar, hippocampal, and cortical samples were collected on PD 9 and analyzed for MDA and GSH content. The results indicated that MDA concentrations in the cerebellum were significantly elevated in animals receiving alcohol; however, MDA levels in the hippocampus and cortex were not affected by alcohol treatment. Additionally, GSH levels in the cerebellum were significantly elevated in groups receiving alcohol, regardless of antioxidant treatment. Neither antioxidant was able to protect against alcohol-induced alterations of MDA or GSH. These findings suggest that alcohol might increase GSH levels indirectly as a compensatory mechanism designed to protect the brain from oxidative-stress-mediated insult.

Antioxidant pretreatment does not ameliorate alcohol-induced Purkinje cell loss in the developing rat cerebellum.

BACKGROUND: Recent research has suggested that oxidative stress is a potential mechanism for alcohol-induced injury and that supplementation with antioxidants can ameliorate alcohol-induced damage. In this study, two known antioxidants, melatonin and U83836E, were assessed for their effectiveness in blocking the expected alcohol-induced cerebellar Purkinje cell loss in neonatal rat pups. METHODS: Sprague-Dawley rat pups were artificially reared from postnatal days (PDs) 4-9 and were exposed to either alcohol or antioxidants (melatonin or U83836E) individually or in combination. A normal control group (raised by rat dams) was included in this study. On PD 9, the brain from each pup was removed and weighed, and the cerebellar vermis was processed for stereological cell counting. RESULTS: Alcohol exposure during the brain growth spurt produced microencephaly, in addition to significant decreases in the number and density of Purkinje cells in lobule I and the volume of lobule I. The antioxidants did not reduce any of the adverse effects observed from alcohol exposure, and they did not decrease the Purkinje cell number when administered alone. Furthermore, antioxidants did not change the only blood alcohol concentration measured on PD 6. CONCLUSIONS: The results confirmed alcohol-induced microencephaly and cerebellar Purkinje cell loss from neonatal alcohol exposure, and they showed that neither antioxidant could attenuate these adverse effects on the developing brain. The inability of antioxidants to reduce Purkinje cell loss from neonatal alcohol exposure suggests the existence of alternative mechanisms for developmental alcohol-induced Purkinje cell loss.