Costs analysis of cochlear implantation in children.

OBJECTIVES: The study assessed the direct medical costs of the cochlear implantation pathway from the healthcare payer's perspective, in children with bilateral severe to profound hearing loss, from diagnosis to 3 years' follow-up after first implantation. We also compared costs between two populations: congenital and progressive deafness. MATERIAL AND METHODS: A retrospective costs analysis was performed for 56 children who received a cochlear implant in one French pediatric ENT center. The children had severe to profound hearing loss, and were implanted before the age of 10 years. We calculated direct medical costs in 3 phases: diagnosis to pre-implantation assessment, surgical and hospital management of implantation, and 3 years' follow-up. RESULTS: Mean costs were €64,675 (range, €38,709-113,954) per child from diagnosis to 3 years after first implantation. Mean costs in congenital deafness detected on neonatal screening and on progressive deafness were respectively €65,420 and €63,930 (P=0.7). CONCLUSION: The global cost was €64,675 per child from diagnosis to 3 years after first implantation. There was no difference in cost according to congenital versus progressive hearing loss.

Reperfused human cadaver as a new simulation model for colonoscopy: a pilot study.

BACKGROUND: The reperfused human cadaver is a validated simulator for surgery. We aimed to use it as a colonoscopy simulator. METHODS: Novices, intermediates and skilled participants in gastrointestinal endoscopy were included. They performed one colonoscopy on a reperfused human cadaver and reaching rates, time, and length needed to reach anatomical landmarks were reported for construct validity analysis. We also assessed our model realism (SRS survey), educational content (CVS survey) and task load (NASA-TLX index). Score items were collected and defined as "favorable" when items were rated ≥ 5/7 with an inter-quartile range (IQR) overlapping four, and "very favorable" when rated ≥ 5/7 with an IQR excluding four (neutral). Primary endpoints were the rectosigmoid junction (RSJ) reaching rate and the descending colon (DC) reaching time. Secondary objectives were SRS, CVS and NASA-TLX questionnaire results. RESULTS: A total of 11 skilled participants, 5 intermediates and 8 novices were included. Skilled participants reached RSJ more often than novice and intermediary groups, respectively, 100%, 80% and 75% without differing significantly. They reached DC more frequently (100% for skilled, 80% for intermediates and 50% for novices, p = 0.018). The median time to reach RSJ (59, 272 and 686 s for skilled, intermediates and novices group, respectively) and DC (90, 534 and 1360 s for skilled, intermediates and novices) was significantly shorter for skilled participants (both p < .01). Nineteen out of the 22 items composing the realism survey obtained "very favorable" and "favorable" scores. Educational content was designated as "very favorable". Mental, physical, and technical demands were gradually higher the lower the initial level of experience. CONCLUSIONS: Reperfused human cadaver model has the potential to be valid simulation tool for diagnostic colonoscopy training.

The French Cochlear Implant Registry (EPIIC): Perception and language results in infants with cochlear implantation under the age of 24 months.

OBJECTIVE: Multi-centre study of the National French Registry (EPIIC) of patients with cochlear implants, focusing on infants who were operated-on under the age of 24 months between 2012 and 2016. PATIENTS AND METHODS: A total of 615 profoundly deaf infants, who received cochlear implants (CIs) before their second birthday, were included in the registry by different CI centers. Epidemiological, surgical, speech therapy and school, follow-up data were included in the registry, 12, 24, 36 and 48 months thereafter. The following parameters were studied: type of implantation (uni- or bilateral), complications, cause of deafness, category of auditory perception (CAP), Open-set word recognition score (OSW), speech intelligibility rating, lexical comprehension with EVIP (Peabody), communication mode and type of schooling. Bilateral simultaneous CI (BiCI) and unilateral CI (UniCI) groups were compared. RESULTS: There were 744 implantations. The explantation-reimplantation rate, within the four-year follow-up, was just 3.6%. Mean implantation age was 16.0 months, and similar in the two groups (BiCI/UniCI). A total of 51% of children had their first implant between 12 and 18 months, and 15% before 12 months. Implantation was unilateral in 52% of cases. Fifty-six percent of the bilateral procedures were sequential, with a mean delay of 16.8 months for the second implantation. The cause of deafness was unknown in 52% of cases. Of the 48% (297/615) of attributed cases, 32% had clear genetic causes. The remaining deafness was due to cytomegalovirus (CMV, 8%), inner-ear malformation (5%) and meningitis (3%). The main complications were from infections (47%) and internal device failure (25%). Four years post-operation, 84% of the UniCI and 75% of BiCl groups had a CAP≥5, and 83% of UniCl and 100% BiCI had OSW≥80%. Furthermore 74% of UniCI and 77% of BiCI communicated orally and 85% of UniCI and 90% of BiCI integrated into mainstream schooling. CONCLUSION: The French Registry of cochlear implants (EPIIC) is the only such national registry in the world. Our analysis illustrates the immediate benefits of, either single or double, cochlear implantation for language, perception skills and schooling.

The French Cochlear Implant Registry (EPIIC): General indicators.

Cochlear and brainstem implants have been included on the list of reimbursable products (LPPR) in France since March of 2009. The implants were initially inscribed for 5 years, after which an application for renewal with the French National Commission for the Evaluation of Medical Devices and Health Technologies (Commission Nationale d'évaluation des dispositifs médicaux et des technologies de santé - CNEDiMTS) was required [Haute Autorité de santé, 2009]. Upon registration to the list of reimbursable products, the companies and the reference centers for cochlear and brainstem implants were asked to set up a post-registration registry called EPIIC. This article reports the evolution in the EPIIC registry of the general indicators for 5051 patients over the five years from 2012-2016.

The French National Cochlear Implant Registry (EPIIC): Cochlear explantation and reimplantation.

This study aims to determine the frequency and causes of cochlear explants with re-implantation (ERI) after 5 years' follow up of the patients included in the French national EPIIC (étude post-inscription des implants cochléaires) registry tracking patients with cochlear implantation. This multicenter, descriptive prospective study was conducted on 5051 patients enrolled in the EPIIC database between January 2012 and December 2016. Ninety-five patients (1.9%) received a primary implant and an ERI during the study. Of these, four benefitted from two ERIs. The number of ERIs was significantly higher in the pediatric population than among adults. The explantation and reimplantation were performed simultaneously in 86% of cases. The reasons for explantation were: in 46.4% of cases linked to a malfunction of the implant, and in 39.3% of cases for medical or surgical reasons. The number of electrodes inserted was significantly higher after the ERI than after the first implantation. There was just one post-ERI infection for these 95 explanted and re-implanted patients. As well as explantation with reimplantation rarely being necessary, it generally presents no major surgical difficulty and in most cases it allows a better integration than in the first implantation.

The French National Cochlear Implant Registry (EPIIC): Results, quality of life, questionnaires, academic and professional life.

This study concerns the results of cochlear implantation in children and adults from French cochlear implantation centers, monitored at one, two and three years by the Cochlear Implant French Registry EPIIC. This multicenter study enrolled 2603 subjects (1667 adults and 936 children) implanted in one ear. The following parameters were studied: hearing overall performances, monosyllabic or dissyllabic word perception, speech intelligibility, self-assessment questionnaire of Cochlear Implant (CI) benefits (Abbreviated profile of Hearing aid Benefit); professional activity and schooling. This study confirms the ceiling effect in adults' performances after the 1st year and the progressive growth in children's performances. It also shows that the contralateral hearing aid enhances performances compared to the CI alone condition, in all follow-up sessions. The French register of CIs is the only worldwide register of systematic follow-up on a period of three years and more of all adults and children implanted in a country.

The French National Cochlear Implant Registry (EPIIC): Cochlear implantation in adults over 65years old.

OBJECTIVES: To analyze the performance of cochlear implants in French patients aged 65 and over, implanted between 2012 and 2016, using data from the French national registry for cochlear implants (EPIIC). MATERIALS AND METHODS: The French national registry incorporates patient data from before implantation and for three years after implantation, stratified in different age groups (18-39, 40-64years, 65-74years and>75years). Here, we assessed the latter two categories. Hearing was assessed using mono- and disyllabic words in a silent background. The Category of Auditory Performance (CAP) scale was also implemented and subjects took the Abbreviated Profile of Hearing Aid Benefit (Aphab) questionnaire. RESULTS: The population aged over 65 accounted for 38% (n=1193) of the 3178 adult implanted patients. The performance for mono- and disyllabic words in silence, the CAP scores and the APHAB questionnaire answers for ease of communication, background noise and reverberation were dramatically improved at one year post-implantation (P<0.0001 for each score) and remained stable between one and three years thereafter. The percentage improvement was similar across all age groups. The scores for loud-noise intolerance did not change after cochlear implantation in any age group. CONCLUSION: Cochlear implants improve hearing and communication in subjects aged 65 and over, with comparable efficiency to that achieved in younger subjects. Cochlear implantation should thus be proposed whenever hearing aids provide only limited benefit. However, between 2012 and 2016, cochlear implantation was given to less than 1% of the French population aged 65 and over with profound deafness.

The French Cochlear Implant Registry (EPIIC): Cochlear implant candidacy assessment of off-label indications.

OBJECTIVE: Evaluate in France the outcomes of cochlear implantation outside the selection criteria, off-label. MATERIAL AND METHODS: This is a prospective cohort study including adults and children having received a cochlear implant (CI) in an off-label indication, that is outside the criteria established by the "Haute Autorité de santé (HAS)" in 2012. The data was collected from the "EPIIC" registry on recipients who received CIs in France between 2011 and 2014. Speech audiometry was performed at 60dB preimplantation and after one year of CI use, as well as an evaluation of the scores of the quality of life with the APHAB questionnaire, the scores for CAP and the professional/academic status in pre- and post-implantation conditions. Major and minor complications at surgery have been recorded. RESULTS: In total, 590 patients (447 adults and 143 children) with an off-label indication for CIs were included in this study from the EPIIC registry (11.7% of the whole cohort of EPIIC). For adults, the median percentage of comprehension using monosyllabic word lists was 41% in preimplantation condition versus 53% after one year of CI use (P<0.001) and 60% versus 71% in dissyllabic word lists (P<0.001). The CAP scores were 5 versus 6 in pre- and post-implantation conditions respectively (P<0.001) and the APHAB scores were statistically lower after implantation (P<0.001). In the children cohort, the median percentage of comprehension using monosyllabic word lists was 51% in preimplantation condition and 65% after CI (P<0.001), and 48% versus 82% (P<0.001) for dissyllabic word lists. The CAP scores were 5 versus 7 respectively in pre- and post-CI conditions (P<0.001). Thirty-two minor complications (5.4%) and 17 major complications (2.8%) were reported in our panel of off-label indication patients. CONCLUSION: These results suggest that a revision of the cochlear implantation candidacy criteria is necessary to allow more patients with severe or asymmetric hearing loss to benefit from a CI when there is an impact on quality of life despite the use of an optimal hearing aid.

The French National Cochlear Implant Registry (EPIIC): Bilateral cochlear implantation.

OBJECTIVES: Assessment of the incidence and results of bilateral cochlear implantation in adults and children in France. MATERIALS AND METHODS: Multicenter retrospective study of data in the French national registry of cochlear implantations from January 1st 2012 to December 31st 2016. Functional results from CAP (Category of Auditory Performance) questionnaires and speech audiometry tests, with mono- and di-syllabic word-lists, were compared before and after implantation. Speech audiometry tests were carried out against a noisy background, except before simultaneous implantations. RESULTS: Nine hundred and forty two bilateral cochlear implantations were performed during this period, that is, 16.4% of all cochlear implantations. Five hundred and eighty eight bilateral implantations were performed sequentially. 59% of the bilateral implantations were performed in children. Bilateral implants significantly improved CAP scores in all cases (P<0.001). Auditory performance, with the two types of word-list, were significantly improved after simultaneous implantation (P<0.01). After sequential implantation, the speech discrimination score, already very good with the first implant, reached 63±26% [0-100] with monosyllabic word lists, and 72±28% [0-100] with dissyllabic words. There were more complications due to surgery in bilateral cases than in the entire population of cochlear recipients (9.1% vs 6.4%, P<0.02). CONCLUSION: Hearing is significantly improved by simultaneous cochlear implantation. For sequential implantation, at one year, when auditory results were already excellent from the first implant, in the bimodal condition CAP scores were significantly improved, although there was no further change in speech audiometry in noise.

The French Cochlear Implant Registry (EPIIC): Cochlear implantation complications.

OBJECTIVES: The aim of this study was to evaluate peri- and post-operative complications related to cochlear implantations. We searched for risk factors predicting these complications and analyzed the complications in the youngest and most elderly. STUDY DESIGN: Retrospective analysis of cochlear implant patients. MATERIALS AND METHODS: All patients who underwent cochlear implantation in France between January 2012 and December 2016 were anonymized and registered in the EPIIC database. This population included 3483 adults and 2245 children. Their demographic and surgical data and their incidence of peri- or post-operative complications, including their severity, whether major or minor, were all indicated. RESULTS: The global complication rate was 6.84%. The risk of complication was higher in initial implantation versus reimplantation (P<0.0001). The risk was also higher for bilateral implantation versus unilateral (P<0.0001). Complications were more frequent for patients with cochlear malformation (P=0.002). There was no difference in complication rates across age groups; babies under 1 year old, and the elderly over 80 and even over 90, did not have more complications than the rest of the population. Patients treated in the daily care unit had no more complications than those who were hospitalized for one night or more (P=0.64). CONCLUSION: Cochlear implantation is a safe technique with a low incidence of complications. The absence of increased risk in patients at the extremes of the age spectrum justifies offering this solution to all, without age limitation.

[The tumors of the ear]. / Les tumeurs de l'oreille.

Any cutaneous lesion of the outer ear must be managed jointly by a dermatologist and an ENT, regardless of the age of the patient. The presence of a malignant cutaneous carcinoma (Squamous cell carcinoma or melanoma) of the pavilion requires a minimum extension assessment by a cervical ultrasound, CT-scan and MRI will be prescribed according to the degree of infiltration and the presence of clinics signs (lymphadenopathy, facial paralysis, cognitive impairment). A polyp of the external auditory meatus must be systematically biopsied in consultation and, if necessary, in the operating room with fresh anatomopathological analysis. Any "otitis externa", which does not progress favorably under local treatment, must lead to eliminate a tumoral pathology of the external acoustic meatus or of the middle ear. Any suspicion of cholesteatoma should lead to an ENT consultation to confirm the diagnosis and consider its treatment to limit the auditory dysfunction. Any unilateral neurosensorial hearing loss or unilateral vestibular involvement with normal otoscopy should lead to eliminate a inner ear tumor by an MRI of the inner ear and the ponto-cerebellar angle in millimeter sections.

Assessment and management of cervico-mediastinal goiter.

Cervico-mediastinal goiter is a particular entity from the point of view of thyroid surgery. Its volume, hardness and intrathoracic extension require the surgeon to adapt technique and perform a painstaking preoperative work-up, so as to draw up fully-fledged plan. CT is now indispensable, to anticipate risks and determine whether sternotomy is needed. Surgery seems to induce more postoperative complications than in conventional surgery, although they can be reduced by retrograde dissection of the inferior laryngeal nerve and downward dissection of the posterior side of the lobe to optimize control of adjacent structures. This surgery requires optimal teamwork between all of the specialties involved in patient management: medical, radiological, anesthesiological and surgical.

Embryo Form Project: An original technique for the three-dimensional reconstruction of human embryo morphology.

Our current knowledge on the developmental stages of human embryogenesis has derived from limited numbers of classical studies. Computer technology now permits accurate 3D reconstruction of embryo morphology from serial histological sections. We present a successful technique that uses either fresh or preserved serial histological sections to generate highly detailed 3D image reconstructions of very small human embryos. We present the data we obtained from the reconstruction in virtual space of previously sectioned 15 and 22.5mm embryos. Their morphologies were studied using a DICOM viewer which permitted the analysis of any specific structure in any required orientation. To our knowledge, this is the first time human embryos have been reconstructed in this way. We believe that this reconstruction technique could improve our knowledge on embryo morphogenesis, especially if coupled to the study of genes involved in embryonic development. It may also prove to be a useful pedagogical tool.

Growth and structure of ultrathin alumina films on the (1 1 0) surface of γ-Al4Cu9 complex metallic alloy.

The first stages of oxidation of the (1 1 0) surface of a γ-Al(4)Cu(9) complex metallic alloy were investigated by combining x-ray photoemission spectroscopy, low energy electron diffraction and scanning tunnel microscopy studies. Oxidation at room temperature in the 2 × 10(-8) to 2 × 10(-7) mbar oxygen pressure range occurs in two steps: a fast regime is followed by a much slower one, leading to the formation of a thin aluminium oxide film showing no long range order. Cu-O bonds are never observed, due to fast oxygen induced aluminium segregation. The low value of the estimated activation energy for aluminium diffusion (0.65 ± 0.12 eV at(-1)) was ascribed to the presence of two vacancies in the γ-Al(4)Cu(9) structure. Annealing at 925 K the oxide film formed at room temperature leads to the formation of small crystallized domains with a sixton structure similar to structures reported in the literature following the oxidation of Cu-9% Al(1 1 1), NiAl (1 1 0) and FeAl(1 1 0) surfaces as well as ultrathin Al films deposited onto Cu(1 1 1) or Ni(1 1 1) surfaces. Two contributions were observed in the O1s peaks, which have been ascribed to loosely bound oxygen species and oxygen belonging to the sixton structure respectively.

Persistent stapedial arteries in human: from phylogeny to surgical consequences.

The stapedial artery is an embryonic artery which disappears during the tenth week in utero, in human species. During its short life, this artery shapes the stapes and transforms the middle meningeal artery from the internal carotid artery to a branch of the external carotid system. Nevertheless, a persistent stapedial artery is seen in 0.2-4.8 per thousand of human adults. This persistence is usually asymptomatic but can sometimes cause pulsatile tinnitus or conductive hearing loss. Despite the risk of facial palsy, hearing loss and even hemiplegia argued by several authors, some surgeons have succeeded in coagulation without side effects. Reviewing the literature, we seek to enlighten the actual knowledge about the persistent stapedial artery to evaluate the risk to coagulate it. Embryologic studies explain the four types of persistent stapedial arteries: the hyoido-stapedial artery, the pharyngo-stapedial artery, the pharyngo-hyo-stapedial artery and aberrant internal carotid with persistent stapedial artery. Phylogenetic studies show that the stapedial artery persists in adulthood in many vertebrates. Its disappearance is therefore either a random effect or an adaptative convergence. This adaptation could be partially linked to the negative allometry of the stapes. Practically, the risk to coagulate a stapedial artery seems limited thanks to anastomoses, for example with the stylomastoid artery. The risk of hemiplegia reported is in fact an extrapolation of variation in rats' embryos. A persistent stapedial artery can therefore reasonably be coagulated, with special attention to the facial nerve, because the facial canal is always dehiscent where the artery penetrates.

In vivo characterization of the vestibulo-cochlear nerve motion by MRI.

The motion of the vestibulo-cochlear nerve (VCN) was quantified at the level of the cerebello-pontine angle in 28 healthy volunteers enrolled in a prospective study performed on a 3T MRI scanner. A phase contrast MRI (PCMRI) sequence was used. The VCN was divided into a cisternal part and a meatic part, both of which were measured for motion in the cranio-caudal (CC) and antero-posterior (AP) directions. Motion was cardiac-cycle-dependent in these two directions. The meatic VCN motion was delayed compared to the cisternal VCN motion. In the CC direction, the mean amplitude of the cisternal VCN motion was twice larger than the mean amplitude of the meatic VCN motion (0.37+/-0.14 mm versus 0.17+/-0.08 mm). In the AP direction, the mean amplitude of the cisternal VCN was 0.19+/-0.08 mm versus 0.16+/-0.14 mm for the meatic VCN. We used an "oscillating string" to explain the VCN motion. Reproducibility tests have shown small variations in measurements of the CC motion. PCMRI can be used to assess the VCN motion at the level of the cerebello-pontine angle.

[Treatment of voice prosthesis leakage. Preliminary results]. / Traitement des fuites sur prothèse phonatoire. Résultats préliminaires.

UNLABELLED: Numerous voice prostheses have been developed since the early eighties. The device, located in the tracheo-esophageal wall, can generate local complications. The most frequent and the hardest to treat is peri-prosthetic salivary leakage. OBJECTIVE: To present a new management scheme for peri-prosthetic salivary leakage by BIOPLASTIQUE injection. PATIENTS AND METHOD: Five patients, with residual peri-prosthetic salivary leakage after different treatments were managed by peri-prosthetic injection of BIOPLASTIQUE, a medical silicone elastomere. The injection was performed under general anesthesia in four points around the prosthesis: above, below, left and right. RESULTS: Leakage disappeared after one or two injections in all patients. No technical problem was encountered. CONCLUSION: Although this method still has to pass the test of time, our preliminary results are encouraging. Such a procedure could be performed under local anesthesia in order to minimize its cost.

An anatomical study of the vestibulocochlear anastomosis (anastomosis of Oort) in humans: preliminary results.

Von Oort first described the vestibulocochlear anastomosis in 1918, and there have been very few anatomical studies of it. It is located at the bottom of the internal auditory meatus and links the saccular nerve to the cochlear nerve. The aim of this study was to investigate the micro-anatomical characteristics of this anastomosis. We dissected 10 human temporal bones from five heads. We found the vestibulocochlear anastomosis in seven of the specimens, of which six were clearly visible. We were unable to uncover it in three specimens due to dissection problems. Its length was evaluated to be between 0.5 and 1 mm, with a diameter of 0.5 mm. The vestibulocochlear anastomosis could be the pathway for the nerve fibers of the cochlear efferent system, whose description remains incomplete. However, no anatomist, histologist or physiologist has demonstrated this function. From the results of this study, it seems likely that the vestibulocochlear anastomosis exists. Other studies are necessary to link it to the efferent system.

[Sinuso-nasal sarcoidosis]. / Les localisations naso-sinusiennes de la sarcoïdose.

OBJECTIVES: Sinonasal sarcoidosis is unusual and may be misdiagnosed. We describe the characteristic clinical presentation observed in three patients treated in our institution and define the complementary explorations leading to diagnosis. Basis for treatment is also developed. PATIENTS AND METHODS: Among one hundred and one patients treated for sarcoidosis between 1983 and 2003 in three department of RD Hospital, three had histologically proved sinonasal sarcoidosis. These three cases were retrospectively analyzed and compared with the literature. RESULTS: All patients complained of chronic rhinosinusitis without improvement under usual treatment. Computed tomography showed usual aspects of chronic rhinosinusitis. The diagnosis was finally based on the biopsy of the nasal mucosa. Even if sarcoidosis had been already diagnosed, the main point was the delay between ENT symptoms and diagnosis because all clinical presentations and radiological aspects were aspecific. CONCLUSION: This case report underlines the difficulty to diagnose sinonasal sarcoidosis. When a patient is treated for sarcoidosis, sinonasal localization of the disease must be suggested in the event of chronic rhinosinusitis. On the other hand, sarcoidosis must be suggested and specific complementary examination must be performed in the event of chronic rhinosinusitis without improvement under usual treatment. ENT biopsy remains the main argument for diagnosis.

[Fundamentals of the anatomy of oculomotor behavior]. / Les bases anatomiques de l'oculomotricité.

The oculomotricity rests on complex anatomo-physiological bases and allows the binocular vision, which is a sensory function very completed in the human. After a short embryologic recall, the binocular vision is defined. The anatomical structures, which take part in the binocularity, are reviewed within three functional stages: an effector peripheral stage (eye ball, extrinsic muscles and their nerves), a sub cortical central stage, generator of the movements (oculomotor nuclei, reticularis formation...), and a central, cortical and subcortical stage, incitator of the movements (cortical areas, vestibular nuclei, cerebellum...). These anatomical bases make it possible to understand the many disorders observed in pathology.