24 research outputs found

    An Updated Review of Subglottic Stenosis: Etiology, Evaluation, and Management

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    Purpose of Review To assimilate the newly published literature regarding subglottic stenosis (SGS), including basic science and translational research on mechanisms of etiology, clinical diagnostics, and therapeutic treatments. Recent Findings The role of inflammation in development of iatrogenic and idiopathic SGS (iSGS) is continuing to be studied. The IL-23/IL-17A inflammatory axis appears to be a potential mechanism for development of iSGS. Additionally, as anticipated in an inflammatory milieu, PD-1/PD-L1 expression is upregulated. If the PD-1/PD-L1 axis is important in SGS pathogenesis, then it may represent a potential target for immunotherapeutic inhibition, given its success in cancer treatment. In terms of surgical management, prospective studies show that endoscopic approaches have more frequent recurrence compared to open techniques. Summary SGS arises from various etiologies, and further understanding of its pathogenesis can aid in the development of novel therapies. It is imperative to obtain a thorough history for each patient presenting with respiratory complaints, as misdiagnosis can delay proper treatment. Endoscopic and open surgical techniques continue to be investigated in a growing number of prospective clinical trials to determine optimal treatment protocols. In-office injections are gaining popularity and show promise in the treatment of SGS

    Adverse events associated with the Inspire implantable hypoglossal nerve stimulator: A MAUDE database review

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    © 2020 Elsevier Inc. Background: Implantable hypoglossal nerve stimulation (HNS) has been found to be a safe and effective therapy for patients with obstructive sleep apnea, and patient adherence to treatment has been found to be as high as 86% after 12 months of therapy. Objective: The purpose of this study is to review the medical device reports (MDRs) submitted to the Food and Drug Administration\u27s (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events related to HNS therapy that could hinder compliance. Methods: A search of the FDA MAUDE database was conducted using the product code “MNQ” for “Inspire stimulator for sleep apnea.” Reports of adverse events associated with Inspire for sleep apnea from January 2000 to May 2020 were included for analysis. From these included reports, event variables were collected, including event setting, adverse event to patient, iatrogenic injury, device malfunction, interventions, and root causes. Results were compiled and reviewed. Results: The search query yielded 180 reports that met inclusion criteria, containing a total of 196 adverse events. The most commonly reported adverse events to patients were infection (n = 50, 34.2%), neuropraxia (n = 22, 15.1%) and hematoma/seroma (n = 17, 11.6%). A total of 83 adverse events (42.3%) required reoperation. The most common reoperations performed for adverse events to patients were explantation (n = 30, 46.2%) and device repositioning/lead revision (n = 24, 36.9%), while the most common reoperation performed for device malfunctions was device replacement (n = 10, 55.6%). Conclusion: In attempting to further improve patient compliance, understanding these device malfunctions and adverse events related to HNS implantation or usage is crucial for the identification of potential causes of patient non-adherence

    Adverse events associated with the Inspire implantable hypoglossal nerve stimulator: A MAUDE database review.

    No full text
    © 2020 Elsevier Inc. Background: Implantable hypoglossal nerve stimulation (HNS) has been found to be a safe and effective therapy for patients with obstructive sleep apnea, and patient adherence to treatment has been found to be as high as 86% after 12 months of therapy. Objective: The purpose of this study is to review the medical device reports (MDRs) submitted to the Food and Drug Administration\u27s (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events related to HNS therapy that could hinder compliance. Methods: A search of the FDA MAUDE database was conducted using the product code “MNQ” for “Inspire stimulator for sleep apnea.” Reports of adverse events associated with Inspire for sleep apnea from January 2000 to May 2020 were included for analysis. From these included reports, event variables were collected, including event setting, adverse event to patient, iatrogenic injury, device malfunction, interventions, and root causes. Results were compiled and reviewed. Results: The search query yielded 180 reports that met inclusion criteria, containing a total of 196 adverse events. The most commonly reported adverse events to patients were infection (n = 50, 34.2%), neuropraxia (n = 22, 15.1%) and hematoma/seroma (n = 17, 11.6%). A total of 83 adverse events (42.3%) required reoperation. The most common reoperations performed for adverse events to patients were explantation (n = 30, 46.2%) and device repositioning/lead revision (n = 24, 36.9%), while the most common reoperation performed for device malfunctions was device replacement (n = 10, 55.6%). Conclusion: In attempting to further improve patient compliance, understanding these device malfunctions and adverse events related to HNS implantation or usage is crucial for the identification of potential causes of patient non-adherence

    I\u27m All Ears: A Population-Based Analysis of Consumer Product Foreign Bodies of the Ear

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    OBJECTIVES: The purpose of this study was to assess the nationwide incidence of ear foreign body (FB) presentations to the emergency department (ED) and analyze the most common FB consumer products encountered. METHODS: The National Electronic Injury Surveillance System (NEISS) was evaluated for ED visits that included ear foreign bodies from 2010 through 2019. The most frequent foreign bodies were identified and organized by demographics. RESULTS: A total of 20,545 ear FB cases were found, with an estimated 608,860 ED visits nationwide. Female patients (56%) were more likely to have jewelry and first aid equipment FBs. Males between the ages of 5 and 15 years were significantly ( \u3c 0.05) more likely to have paper products, pens/pencils, and desk supplies in their ears. CONCLUSION: Ear FBs represent a substantial proportion of healthcare expenditures. Although children are the most commonly affected individuals, all ages require further education and preventive measures

    Otolaryngology-related Google Search trends during the COVID-19 pandemic.

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    OBJECTIVE: To assess trends of Google Search queries for symptoms and complaints encountered commonly in otolaryngology practices during the coronavirus disease 2019 (COVID-19) pandemic when in-person care has been limited. MATERIALS AND METHODS: In this cross-sectional study, data on Google Search queries in the United States for 30 otolaryngology-related terms were obtained from Google Trends. The means of relative search volume from the COVID-19 period (March 29, 2020 through May 16, 2020) were compared to similar periods from 2016 to 2019 using a t-test of two independent samples. RESULTS: In total, 16.6% of search terms had significant increases in relative search volume during the COVID-19 period, with the largest percentage increase for can\u27t smell (124.4%, p = .006), followed by allergies (30.3%, p = .03), voice pain (26.1%, p = .008), and ears ringing (19.0%, p \u3c .001). Of all search terms, 26.7% had significant decreases in relative search volume, including the largest percentage decrease for laryngitis (59.8%, p \u3c .001), followed by thyroid nodule (54.4%, p \u3c .001), thyroid cancer (45.6%, p \u3c .001), and ENT (34.9%, p \u3c .001). CONCLUSION: This study demonstrates that Google search activity for many otolaryngology-related terms during the COVID-19 pandemic has increased or decreased significantly as compared to previous years. With reduced access to in-office otolaryngology care in the United States during the COVID-19 pandemic, these are important considerations for otolaryngology practices to meet the needs of patients who lack access to care

    Adverse Events Associated With Ossicular Prostheses: Utility of a Federal Database

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    OBJECTIVES: Ossicular prostheses have demonstrated utility in ossicular chain reconstruction, but their use also is associated with complications. This study aims to explore the utility of the U.S. Food and Drug Administration\u27s Manufacturer and User Facility Device Experience (MAUDE) database for the systematic analysis of complications associated with ossicular prostheses. It also summarizes adverse events to patients (AEPs) and device malfunctions (DMs) reported in the MAUDE database, and attempts to examine the consequences brought about by these events and to identify likely root causes. STUDY DESIGN: Retrospective analysis of the MAUDE database. METHODS: The MAUDE database was queried for reports from January 2010 to May 2020. Data were extracted from reports involving the use of ossicular prostheses. RESULTS: Seventy-three medical device reports, reports submitted to the Food and Drug Administration detailing suspected device-associated malfunctions, injuries, and deaths, involved ossicular prostheses and were included for analysis, from which 126 adverse events were extracted. Of these, 50 (39.7%) were AEPs, while 76 (60.3%) were DMs. The most common AEPs were foreign body and hearing loss, while the DMs reported most commonly were broken prosthesis and displaced prosthesis. Of the 76 DMs, 19 (25%) were attributed to mishandling by the operator, while 6 (7.9%) were due to a defective device. Broken prosthesis was the DM most commonly attributed to mishandling by the operator in 16 (32.7%) cases. CONCLUSION: Ossicular prostheses are used extensively for ossicular chain reconstruction, but also are associated with adverse events. The MAUDE database in its current form does not appear sufficient for the systematic review of adverse events associated with ossicular prostheses. A more standardized reporting format with clearly defined categories and inclusion of relevant variables might improve the quality of information provided by the MAUDE database
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