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Δευτέρα 14 Δεκεμβρίου 2020

Potential Gene Therapy Trials in Autosomal Dominant Progressive Sensorineural Hearing Loss

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Background: Advances in gene therapeutic approaches to treat sensorineural hearing loss (SNHL) confront us with future challenges of translating these animal studies into clinical trials. Little is known on patient attitudes towards future innovative therapies. Objective: We aimed to better understand the willingness of patients with progressive SNHL and vestibular function loss of autosomal dominant (AD) inheritance to participate in potential gene therapy trials to prevent, stabilize, or slow down hearing loss. Methods: A survey was performed in carriers of the P51S and G88E pathogenic variant in the COCH gene (DFNA9). Various hypothetical scenarios were presented while using a Likert scale. Results: Fifty three participants were included, incl. 49 symptomatic patients, one presymptomatic patient, and three participants at risk. Their attitude towards potential trials studying innovative therapies was overall affirmative, even if the treatment would only slow down the decline of hearing and vestibular function, rather than cure the disease. Among the different potential scenarios, the less invasive and less frequent treatments increased the likelihood to enroll. Daily oral medication and annual intravenous infusion were awarded the highest scores. The more invasive, more frequent, and more at-risk treatments were still likely to be accepted but decreased the willingness to participate. The presence of a placebo arm was met with the lowest scores of willingness to participate. Conclusions: Overall, most symptomatic DFNA9 patients would likely consider participation in future innovative inner ear therapy trials, even if it would only slow down the decline of hearing and vestibular function. Address correspondence and reprint requests to Camille Levie, M.D., Department of Otorhinolaryngology and Head & Neck surgery, Antwerp University Hospital, Wilrijkstraat 10, 2610 Edegem, Belgium; E-mail: camille.levie@uza.be Disclosure of funding: The authors received no specific funding for this work. The authors disclose no conflicts of interest. Copyright © 2020 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company
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Management of Intractable Petrous Bone Cholesteatoma With a Combined Translabyrinthine–Transsphenoidal Approach

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Objective: To evaluate whether a combined translabyrinthine–transsphenoidal approach can be used to achieve adequate surgical resection of an extensive petrous bone cholesteatoma and create a debris drainage route for the residual cholesteatoma that is maintained long-term. Patient: A 71-year-old man with residual petrous temporal bone cholesteatoma that had spread extensively to the internal carotid artery and posterior cranial fossa. Intervention: Surgical resection of the cholesteatoma via a translabyrinthine approach and creation of a debris drainage route into the nasopharynx via a transsphenoidal approach. Main Outcome Measures: Control of unresectable petrous temporal bone cholesteatoma and occurrence of cholesteatoma- or surgery-related complications. Results: Although complete removal of the cholesteatoma was attempted via a translabyrinthine approach, this was not possible because the epithelium of the cholesteatoma was strongly attached to the internal carotid artery and posterior cranial fossa. A debris drainage route leading to the nasopharynx was created by drilling the clivus on the side of the lesion via a transsphenoidal approach. The patient has had no complications since surgery. The drainage route remains open, and the cholesteatoma has been controlled for 57 months. Conclusions: A markedly advanced petrous temporal bone cholesteatoma can be managed safety and reliably by combining a translabyrinthine approach with a transsphenoidal approach. Creation of a debris drainage route into the nasopharynx can prevent isolation of the cholesteatoma and mastoid cavity problems after surgery. This one-stage surgery may be a suitable method for keeping cholesteatoma under control in patients with unresectable petrous bone cholesteatoma. Address correspondence and reprint requests to Tsunetaro Morino, M.D., Ph.D., Department of Otorhinolaryngology, Jikei University School of Medicine, 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, Japan; E-mail: moritune@jikei.ac.jp The study received no source of funding. The authors disclose no conflicts of interest. Copyright © 2020 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company
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Subjective Visual Vertical Evaluation by a Smartphone-Based Test—Taking the Phone Out of the Bucket

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Objective: To measure the subjective visual vertical (SVV) in patients suffering from peripheral vestibular disorders versus controls, using a smartphone-based test designed to simulate the bucket test, in order to validate it as an available tool for the clinician. Study design: Prospective cohort study. Setting: Academic tertiary medical center. Patients: Forty-five adult patients were recruited to the study, 25 had vestibular disorders, and 20 did not (controls). Intervention: All patients underwent conventional bucket-SVV (b-SVV) and smartphone-based SVV (s-SVV) testing. Main outcome measures: Correlation and agreement of b-SVV and s-SVV scores in patients with peripheral vestibular disorders compared to controls. Results: SVV score in the vestibular disorders group was significantly higher compared to controls in both testing methods (p 
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Cochlear Implantation and Electric Acoustic Stimulation in Children With TMPRSS3 Genetic Mutation

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Background: Mutations in the TMPRSS3 gene, although rare, can cause high frequency hearing loss with residual hearing at low frequencies. Several previous studies have reported cochlear implant (CI) outcomes for adults with TMPRSS3 mutation with mixed results. Although some studies have suggested that TMPRSS3 is expressed in spiral ganglion cells, it remains unclear if previously reported poor CI outcomes in this population were secondary to long durations of deafness or to the effects of the TMPRSS3 mutation. To date, no studies in the literature have reported CI outcomes for children with TMPRSS3 mutation treated with CI. Objective: The current case series aimed to describe outcomes for three children with sloping hearing loss caused by TMPRSS3 mutation who underwent bilateral CI. Study Design: Case series. Setting: Academic medical center. Patients: Three children (3–4 yr) with TMPRSS3 mutation and normal sloping to profound high frequency hearing loss. Interventions: CI and electric acoustic stimulation (EAS). Main Outcome Measures: Outcome measures were residual hearing thresholds, speech recognition scores, and electrode placement determined via intraoperative CT imaging. Results: All three children maintained residual acoustic hearing and received benefit from EAS. Mean change in low-frequency pure-tone average was 17 dB. Mean postoperative word and sentence recognition scores in the bilateral EAS condition were 80 and 75%, respectively. Conclusions: Results indicate that CI with EAS is an appropriate treatment for children with TMPRSS3 genetic mutation. Pediatric results from this case series show more favorable CI outcomes than are currently reported for adults with TMPRSS3 mutation suggesting that the intervention may be time sensitive. Address correspondence and reprint requests to Jourdan T. Holder, Au.D., Department of Hearing and Speech Sciences, 1215 21st Avenue South, Medical Center East, South Tower, #9302, Nashville, TN 37232-8605; E-mail: jourdan.t.holder@vumc.org Financial Material & Support: NIH R01 DC13117; PI: R.H.G., PhD. Institutional Review Board: IRB# 130229. Conflict(S) of Interest to Declare: None directly related to this case series. J.T.H.: consultant for Advanced Bionics and Cochlear; A.R.: consultant for Advanced Bionics, Cochlear, MED-EL, Stryker, Grace Medical, Cook Medical; R.H.G.: advisory board for Cochlear, Advanced Bioincs, and Frequency Therapeutics; R.F.L.: consultant for Advanced Bionics and Cochlear. Copyright © 2020 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company
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Usefulness of the Video Head Impulse Test for the Evaluation of Vestibular Function in Patients With Otitis Media With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis

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Objectives: To investigate usefulness of the video Head Impulse Test (vHIT) as a method for evaluating semicircular canal function in patients with otitis media with antineutrophil cytoplasmic antibody-associated vasculitis (OMAAV). Study Design: Retrospective case review. Setting: Tertiary referral center. Patients: Fourteen patients with OMAAV underwent vestibular examination. Main Outcome Measures: The gain in vestibulo-ocular reflex (VOR) and the presence of catch-up saccade were examined for each semicircular canal. Results: Seven (50.0%) of the 14 patients felt subjective symptoms of disequilibrium. Dysfunction in at least one semicircular canal was detected in all ears of the OMAAV patients evaluated by vHIT. Dysfunction in posterior semicircular canal was detected more frequently than that in the anterior or horizontal canal. There were no significant correlations between the gain in VOR and hearing loss. Conclusions: vHIT is thought to be the most suitable method for evaluating semicircular canal function in patients with OMAAV as vHIT is not influenced by middle ear pathology and was able to evaluate vertical canal function including the posterior canal. Address correspondence and reprint requests to Keishi Fujiwara, M.D., Ph.D., Kita-Ku, N15W7, Sapporo 0608638, Hokkaido, Japan; E-mail: boron700@med.hokudai.ac.jp Source of Funding: None declared. The authors disclose no conflicts of interest. Copyright © 2020 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company
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Migraine Features in Patients With Recurrent Benign Paroxysmal Positional Vertigo

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Objectives: To identify migraine features present in a cohort of patients with recurrent benign paroxysmal positional vertigo (BPPV). Methods: Patients presenting with recurrent BPPV were surveyed. Recurrent BPPV was defined as three episodes or greater in 6 months before presentation, with resolution of symptoms after Epley maneuver. Current or past migraine headache (MH) diagnosis was made according to the International Headache Society guidelines. Results: Fifty-eight patients with recurrent BPPV with a mean age of 53.8 ± 17.4 years were included. Half (29 patients) fulfilled criteria for MH and half (29 patients) did not meet the criteria for MH (non-MH). No statistically significant difference was found in a majority of migraine-related symptoms between the MH and non-MH cohorts with recurrent BPPV. History of migraine medication usage (p = 0.008), presence of a weekly headache (p = 0.01), and duration of dizziness after positional vertigo (p = 0.01) were the only variables that were different on multivariate analysis between the MH and non-MH cohorts. Conclusions: Half of recurrent BPPV patients suffer from migraine headaches. The other half presented with migraine-related symptoms, but do not meet criteria for MH. The high comorbidity of MH in our recurrent BPPV cohort as well as the absence of a statistically significant difference in a majority of migraine-related features among patients who did and did not fulfill criteria for MH may suggest that recurrent BPPV has a relationship with migraine. Recurrent BPPV may potentially be a manifestation of migraine in the inner ear, which we term otologic migraine including cochlear, vestibular, or cochleovestibular symptoms. Address correspondence and reprint requests to Hamid R. Djalilian, M.D., Division of Neurotology and Skull Base Surgery, Department of Otolaryngology–Head and Neck Surgery, University of California Irvine, 19182 Jamboree Road, Otolaryngology-5386, Irvine, CA 92697; E-mail: hdjalili@hs.uci.edu D.B., M.A., and B.S. contributed equally to this manuscript. Financial Disclosure: M.A. is supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant TL1TR001415. Conflicts of Interest: None. Copyright © 2020 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company
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Robot-assisted Cochlear Implant Electrode Array Insertion in Adults: A Comparative Study With Manual Insertion

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Objective: To describe the first cochlear array insertions using a robot-assisted technique, with different types of straight or precurved electrode arrays, compared with arrays manually inserted into the cochlea. Study Design: Retrospective review. Setting: Tertiary otologic center. Patients: Twenty cochlear implantations in the robot-assisted group and 40 in the manually inserted group. Interventions: Cochlear implantations using a robot-assisted technique (RobOtol) with straight (eight Cochlear CI522/622, and eight Advanced Bionics Hifocus Slim J) or precurved (four Advanced Bionics Hifocus Mid-Scala) matched to manual cochlear implantations. Three-dimensional reconstruction images of the basilar membrane and the electrode array were obtained from pre- and postimplantation computed tomography. Main Outcome Measures: Rate and localization of scalar translocations. Results: For straight electrode arrays, scalar translocations occurred in 19% (3/16) of the robot-assisted group and 31% (10/32) of the manually inserted group. Considering the number of translocated electrodes, this was lower in the robot-assisted group (7%) than in the manually inserted group (16%) (p 
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ΦΕΚ 5486/12-12-2020 τΒ΄ Έκτακτα μέτρα προστασίας της δημόσιας υγείας από τον κίνδυνο περαιτέρω διασποράς του κορωνοϊού COVID-19 από 13/12/2020 έως 7/1/2021

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ΦΕΚ 5486/2020 τΒ΄

Αριθμ. Δ1α/ΓΠ.οικ. 80189
Έκτακτα μέτρα προστασίας της δημόσιας υγείας από τον κίνδυνο περαιτέρω διασποράς του κορωνοϊού COVID-19 στο σύνολο της Επικράτειας για το διάστημα από την Κυριακή 13 Δεκεμβρίου 2020 και ώρα 6:00 έως και την Πέμπτη 7 Ιανουαρίου 2021 και ώρα 6:00.

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Ν.4761/ΦΕΚ 248 A’/13.12.2020 Εθνική Εκστρατεία Εμβολιασμού κατά του κορωνοϊού COVID-19 κλπ

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N 4761 ΦΕΚ 248/13-12-2020 τΑ΄
Αναδιοργάνωση του Ταμείου Αρχαιολογικών Πόρων και Απαλλοτριώσεων και μετονομασία του σε Οργανισμό Διαχείρισης και Ανάπτυξης Πολιτιστικών Πόρων, προβολή της πολιτιστικής κληρονομιάς στο εξωτερικό, ρυθμίσεις για το Ιστορικό Μουσείο Κρήτης και το μουσείο «Φοίβος Ανωγειανάκης» και άλλες διατάξεις.

ΜΕΡΟΣ Ζ'
ΡΥΘΜΙΣΕΙΣ ΣΤΟ ΠΛΑΙΣΙΟ ΤΩΝ ΕΚΤΑΚΤΩΝ ΜΕΤΡΩΝ ΚΑΤΑ ΤΟΥ ΤΟΥ ΚΟΡΩΝΟΪΟΥ COVID-19
Άρθρο 70 Παράταση της ισχύος των πιστωτικών σημειωμάτων λόγω ακύρωσης ή αναβολής πολιτιστικών εκδηλώσεων – Τροποποίηση του άρθρου 16 του ν. 4708/2020
Άρθρο 71 Ενταλματοποίηση και καταβολή δεδουλευμένων εφημεριών και αποζημίωση δαπανών από εξετάσεις βιολογικού υλικού
Άρθρο 72 Επιτροπή διαπραγμάτευσης τιμής φαρμάκων – Συμπλήρωση εξουσιοδοτικής διάταξης – Τροποποίηση του άρθρου 254 του ν. 4512/2018
Άρθρο 73 Διενέργεια ελέγχων φορείας του κορωνοϊού COVID -19 για επιδημιολογικούς λόγους
Άρθρο 74 Εθνική Εκστρατεία Εμβολιασμού κατά του κορωνοϊού COVID-19

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Loss of exosomal miR-146a-5p from cancer-associated fibroblasts after androgen deprivation therapy contributes to prostate cancer metastasis

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Androgen deprivation therapy (ADT) is the backbone of therapy for advanced prostate cancer (PCa). Despite the good initial response, castration resistance and metastatic progression will inevitably occur. Canc...
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The biomarkers related to immune related adverse events caused by immune checkpoint inhibitors

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The enthusiasm for immune checkpoint inhibitors (ICIs), an efficient tumor treatment model different from traditional treatment, is based on their unprecedented antitumor effect, but the occurrence of immune-r...
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