21 research outputs found

    Bioactive glass in canal wall reconstruction tympanoplasty

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    The purpose of this Technical Note is to describe the surgical technique to transform canal wall down tympanoplasty into canal wall up tympanoplasty, that is, to rehabilitate a recess cavity by filling the mastoid and epitympanic cavities with synthetic tissue (bioactive glass) and recreating a normal-caliber external auditory canal. Mastoid cavity obliteration leads to a clinically significant improvement in health-related quality of life without increasing risk of recurrent or residual cholesteatoma, conditional upon technically impeccable surgery.L'objectif de cette note technique est de décrire la technique chirurgicale permettant de transformer une technique ouverte en une technique dite « refermée ». Il s'agit donc de réhabiliter une cavité d'évidement en comblant les cavités mastoïdienne et épitympanique avec du tissu synthétique (bioverre), et en recréant un méat acoustique externe de calibre normal. Cette intervention permet d'améliorer de façon significative la qualité de vie des patients opérés sans augmenter le risque de cholestéatome récidivant ou résiduel, à condition de parfaitement maitriser la technique chirurgicale

    Otoskills training during covid-19 pandemic: a before-after study

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    International audienceBackground: The ongoing COVID-19 pandemic has disrupted the surgical training of residents. There is a real concern that trainees will not be able to meet their training requirements. Low-fidelity surgical simulation appears to be an alternative for surgical training. The educational benefits of repeating ossiculoplasty simulations under a microscope have never been evaluated. With this study we aimed to evaluate the differences in performance scores and on a global rating scale before and after training on an ossiculoplasty simulator. Methods: In this quasi-experimental, prospective, single-centre, before-after study with blinded rater evaluation, residents performed five microscopic ossiculoplasty tasks with a difficulty gradient (sliding beads onto rods, the insertion of a partial prosthesis, the insertion of a total prosthesis, and the insertion of a stapedotomy piston under microscopic or endoscopic surgery) before and after training on the same simulator. Performance scores were defined for each task, and total performance scores (score/min) were calculated. All data were collected prospectively. Results: Six out of seven intermediate residents and 8/9 novices strongly agreed that the simulator was an effective training device and should be included in the ENT residency program. The mean effect of training was a significant increase in the total performance score (+ 0.52 points/min, [95 % CI, 0.40-0.64], p < 0.001), without a significant difference between novice and intermediate residents. Conclusions: This preliminary study shows that techniques for middle-ear surgery can be acquired using a simulator, avoiding any risk for patients, even under lockdown measures

    Estimated Costs Associated With Management of Otosclerosis With Hearing Aids vs Surgery in Europe

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    Importance: Surgery and hearing aids have similar outcomes in terms of hearing acuity but differ in terms of cost, aesthetics, and patient quality of life. The cost-effectiveness and budget impact of otosclerosis treatments have never been studied in Europe.Objectives: To compare the estimated mean costs per patient over 10 years of surgery vs hearing aids for the treatment of otosclerosis and to estimate the budget impact of an increase in the proportion of patients receiving surgical treatment.Design, setting, and participants: This economic evaluation analyzed French and European epidemiological data on the surgical management of symptomatic otosclerosis and compared them with data from the literature to build economic models. The analysis was conducted in January 2021.Exposures: Two care pathways were considered in the treatment of otosclerosis, either hearing aid or surgery.Main outcomes and measures: Costs were studied over 10 years using Markov models of the 2 care pathways (hearing aid vs surgery). The budget impact analysis was performed over 5 and 10 years, assuming a 1-percentage point yearly increase in the proportion of patients receiving surgical treatment.Results: Over 10 years, the estimated mean cost per patient was significantly lower in the surgery group compared with the hearing aid group (€3446.9 vs €6088.4; mean difference, -€2641.5; 95% CI -€4064.8 to -€1379.4 [US 3913.4vsUS3913.4 vs US 6912.4; mean difference, -US 2999.0;952999.0; 95% CI, -US 4614.9 to -US 1566.1]).Increasingsurgicaltreatmentby1percentagepointperyearfor10yearswouldleadtooverallsavingsof1762304(US1566.1]). Increasing surgical treatment by 1 percentage point per year for 10 years would lead to overall savings of €1 762 304 (US 2 000 798) in France, with an increase of €1 322 920 (US 1501952)at10yearsforthepublichealthinsurancesystemandadecreaseof3085224(US1 501 952) at 10 years for the public health insurance system and a decrease of €3 085 224 (US 3 502 750) at 10 years for patients and private health insurers. Sensitivity analyses showed that these results were robust.Conclusions and relevance: These results suggest that in France, treating otosclerosis surgically is slightly less expensive over 10 years than using hearing aids, when considering all payers. The proposed models developed in this study could be adjusted to perform the same analysis in other countries

    Prevalence and Characteristics of Altered Sense of Smell/Taste During Covid-19 first wave: A French Nationwide Cross-sectional Study

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    International audienceAim: Altered sense of smell and/or taste is a leading symptom of SARS-CoV-2 infection, but its prevalence at a population-level is unknown. Methods: From a questionnaire addressed to a representative subset of the French general adult (≥ 18-year) population over a 6-week period during the first French lockdown (April 7 to May 19 2020), self-reported new cases of altered sense of smell and/or taste were collected. Results: From 29,660 participants, new altered sense of smell and/or taste was 2.18% and 2.11% after direct standardization on the French population representing more than 1,110,000 subjects in France. Moreover, 0.5% of participants reported a positive SARS-CoV-2 test, among which 47.4% reported a newly altered sense of smell and/or taste. Male participants, younger ones together with those presenting with chronic condition had higher odds of reporting a newly altered sense of smell and/or taste. Conclusion: This study provides an accurate estimate of new cases of altered sense of smell and/or taste in the general population at a nationwide level during the Covid-19 first wave

    Objective diagnosis of internal nasal valve collapse by four‐phase rhinomanometry

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    International audienceBackground: Internal valve collapse is a frequent cause of nasal obstruction but remains poorly understood and is sometimes treated inappropriately as a result. No functional or imaging test for the condition has been validated and the reference diagnostic technique is physical examination. The objective of this study was to evaluate the potential of four-phase rhinomanometry as a diagnostic test for internal valve collapse.Methods: In a case–control diagnostic accuracy study, the nostrils of adult patients consulting for chronic nasal obstruction were classified as “collapsed” or “non-collapsed” based on clinical findings. Four-phase rhinomanometry was performed in all patients. The area defined by the path of the flow/pressure curve in the two phases of inspiration (the “inspiratory loop area” or “hysteresis loop area”) was calculated for both nasal cavities and the threshold value with the highest Youden index was identified.Results: Sixty-six patients (132 nostrils) were included with 72 nostrils classified as collapsed and 60 as non-collapsed. Before nasal decongestion, the inspiratory loop area with the highest Youden index was 17.3 Pa L s−1 and the corresponding sensitivity and specificity were 88.3% (95% confidence interval, 80.0–95.0%) and 89.9% (82.6–95.7%), respectively.Conclusions: In these patients, a cutoff inspiratory loop area in four-phase rhinomanometry data reproduced clinical diagnoses of internal valve collapse with high sensitivity and specificity. This method may offer a firmer basis for treatment indications than subjective physical examinations

    Cross-cultural adaptation of the CRS-PRO questionnaire into French

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    International audienceAbstract Background Chronic rhinosinusitis (CRS), encompasses many different clinical patterns with variable response to treatment. Precise criteria specifying disease severity and control are lacking in the current literature. Our aim was to perform a cross-cultural adaptation of the CRS-PRO, creating a French version for use as a routine questionnaire in the assessment of patients with CRS. Methods The CRS-PRO questionnaire was translated according to the recommendations of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) through a three-step procedure including a backward translation. Results Seven of 12 items were initially discordant between the three translators before achieving consensus (Step 1). Two of 12 items were discordant between the backward translation and the initial CRS-PRO version regarding the word “mucus”(Step 2). Step 3 allowed the creation of a French proof-read version of the CRS-PRO questionnaire. Thirty patients were included for initial validation, mean age of 49.2 ± 15 years and 63.3% (19/30) male. It took them 67 ± 23 s to complete the questionnaire without any patients requiring more than 2 min. Conclusion This study presents the French version of the CRS-PRO questionnaire—an adapted, validated, and well-accepted instrument to evaluate the CRS symptoms in the French speaking population

    In vivo intranasal delivery of coagulation factor IX: a proof-of-concept study

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    Background: Hemophilia B (HB) is a bleeding disorder characterized by coagulation factor (F) IX (FIX) deficiency. The current standard-of-care for severe HB is prophylaxis with long-term repetitive intravenous (i.v.) infusions of recombinant FIX (rFIX) with standard half-life or extended half-life. Unmet needs remain regarding the development of non-invasive administration routes for coagulation factors. The aim of this study was to evaluate the effectiveness of intranasal delivery (IND) of rFIX and rFIX fused to Fc fragment (rFIX-Fc) in mice.Methods: Drops of rFIX and rFIX-Fc were deposited in the nostrils of wild-type, FcRn knockout , FcRn humanized, and FIX knockout mice. rFIX mucosal uptake was evaluated by measuring plasma FIX antigen and FIX activity (FIX:C) levels, and by performing histologic analysis of the nasal mucosa following IND.Results: After IND, both rFIX and rFIX-Fc were equally delivered to the blood compartment, irrespective of the mouse strain studied, mostly through a passive mechanism of transportation across the mucosal barrier, independent of FcRn receptor. Both plasma FIX antigen and FIX:C activity levels increased following IND in FIX knockout mice.Conclusion: This proof-of-concept study describes evidence supporting the nasal route as an alternative to FIX i.v. infusion for the treatment of HB

    FcRn as a Transporter for Nasal Delivery of Biologics: A Systematic Review

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    International audienceFcRn plays a major role in regulating immune homeostasis, but it is also able to transport biologics across cellular barriers. The question of whether FcRn could be an efficient transporter of biologics across the nasal epithelial barrier is of particular interest, as it would allow a less invasive strategy for the administration of biologics in comparison to subcutaneous, intramuscular or intravenous administrations, which are often used in clinical practice. A focused systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. It was registered on the international prospective register of systematic reviews PROSPERO, which helped in identifying articles that met the inclusion criteria. Clinical and preclinical studies involving FcRn and the nasal delivery of biologics were screened, and the risk of bias was assessed across studies using the Oral Health Assessment Tool (OHAT). Among the 12 studies finally included in this systematic review (out of the 758 studies screened), 11 demonstrated efficient transcytosis of biologics through the nasal epithelium. Only three studies evaluated the potential toxicity of biologics’ intranasal delivery, and they all showed that it was safe. This systematic review confirmed that FcRn is expressed in the nasal airway and the olfactory epithelium, and that FcRn may play a role in IgG and/or IgG-derived molecule-transcytosis across the airway epithelium. However, additional research is needed to better characterize the pharmacokinetic and pharmacodynamic properties of biologics after their intranasal delivery
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