Publications by authors named "Daniele Bernardeschi"

56 Publications

Middle ear adenomatous neuroendocrine tumours: Single institution experience with five cases.

Clin Otolaryngol 2021 May 1. Epub 2021 May 1.

APHP, Otology, auditory implants and skull base department, Pitié-Salpêtrière Hospital, Paris, France.

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http://dx.doi.org/10.1111/coa.13791DOI Listing
May 2021

Cochlear Implantation and Other Treatments in Single-Sided Deafness and Asymmetric Hearing Loss: Results of a National Multicenter Study Including a Randomized Controlled Trial.

Audiol Neurootol 2021 Mar 31:1-11. Epub 2021 Mar 31.

Service d'Otologie, Otoneurologie et ORL pédiatrique, Hôpital Pierre-Paul Riquet, CHU Purpan, Toulouse, France.

Introduction: Cochlear implantation is a recent approach proposed to treat single-sided deafness (SSD) and asymmetric hearing loss (AHL). Several cohort studies showed its effectiveness on tinnitus and variable results on binaural hearing. The main objective of this study is to assess the outcomes of cochlear implantation and other treatment options in SSD/AHL on quality of life.

Methods: This prospective multicenter study was conducted in 7 tertiary university hospitals and included an observational cohort study of SSD/AHL adult patients treated using contralateral routing of the signal (CROS) hearing aids or bone-anchored hearing systems (BAHSs) or who declined all treatments, and a randomized controlled trial in subjects treated by cochlear implantation, after failure of CROS and BAHS trials. In total, 155 subjects with SSD or AHL, with or without associated tinnitus, were enrolled. After 2 consecutive trials with CROS hearing aids and BAHSs on headband, all subjects chose any of the 4 treatment options (abstention, CROS, BAHS, or cochlear implant [CI]). The subjects who opted for a CI were randomized between 2 arms (CI vs. initial observation). Six months after the treatment choice, quality of life was assessed using both generic (EuroQoL-5D, EQ-5D) and auditory-specific quality-of-life indices (Nijmegen Cochlear implant Questionnaire [NCIQ] and Visual Analogue Scale [VAS] for tinnitus severity). Performances for speech-in-noise recognition and localization were measured as secondary outcomes.

Results: CROS was chosen by 75 subjects, while 51 opted for cochlear implantation, 18 for BAHSs, and 11 for abstention. Six months after treatment, both EQ-5D VAS and auditory-specific quality-of-life indices were significantly better in the "CI" arm versus "observation" arm. The mean effect of the CI was particularly significant in subjects with associated severe tinnitus (mean improvement of 20.7 points ± 19.7 on EQ-5D VAS, 20.4 ± 12.4 on NCIQ, and 51.4 ± 35.4 on tinnitus). No significant effect of the CI was found on binaural hearing results. Before/after comparisons showed that the CROS and BAHS also improved significantly NCIQ scores (for CROS: +7.7, 95% confidence interval [95% CI] = [4.5; 10.8]; for the BAHS: +14.3, 95% CI = [7.9; 20.7]).

Conclusion: Cochlear implantation leads to significant improvements in quality of life in SSD and AHL patients, particularly in subjects with associated severe tinnitus, who are thereby the best candidates to an extension of CI indications.
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http://dx.doi.org/10.1159/000514085DOI Listing
March 2021

Objective improvement in adults with cerebellopontine angle arachnoid cysts after surgical treatment.

Acta Neurochir (Wien) 2021 03 29;163(3):753-758. Epub 2021 Jan 29.

Department of Neurosurgery - AP-HP, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, 47-83 boulevard de l'hôpital, 75013, Paris, France.

Background: Intracranial arachnoid cysts are extra-axial benign lesions mainly found in the middle cerebral fossa. Rare case series report various cranial nerve dysfunctions associated with cerebellopontine angle (CPA) cysts and there is no consensus with regard to their surgical management; some reports claiming that subjective improvement in adults with intracranial arachnoid cysts cannot justify surgical treatment.

Methods: This retrospective study included all 12 consecutive adult patients treated by microsurgical fenestration for symptomatic CPA arachnoid cysts between 2010 and 2019 and using a retrosigmoid approach. Demographic, clinical, surgical, and radiological data were collected from medical files.

Results: The main symptoms were audiovestibular in 9 patients (75%) complaining of dizziness and 6 patients (50%) with hearing loss. In addition, 3 patients (25%) reported tinnitus, 3 patients (25%) presented vasovagal syncope, and 1 patient (8.3%) reported facial pain. Surgery improved 5 patients (83%) with pre-operative hearing loss, 7 patients (78%) reporting dizziness, and all patients with vasovagal syncope. All of the patients recovered from at least one symptom. No recurrence was observed with a mean follow-up of 5.5 years.

Conclusion: Although most arachnoid cysts are asymptomatic, the CPA location may lead to cranial nerve impairments. Microsurgical fenestration seems to be a simple, safe, and effective technique.
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http://dx.doi.org/10.1007/s00701-021-04721-6DOI Listing
March 2021

Current Management of Large Vestibular Schwannomas for NF2 Patients in a National Reference Center.

Laryngoscope 2021 01 17;131(1):E98-E107. Epub 2020 Aug 17.

Neurosurgical Department, Pitié-Salpétrière Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.

Objective: Recently, treatment decision making for large vestibular schwannomas (VS) in patients with neurofibromatosis type 2 (NF2) has become increasingly challenging due to the availability of multiple therapeutic options including surgery, bevacizumab (an anti-VEGF), radiosurgery, and observation; and it often remains an arbitrary decision based on local practices without firm recommendations. Our objective is to discuss the multimodal treatment options for Koos IV VS in a national reference center for NF2.

Study Design: Single-institution retrospective cohort study.

Methods: All NF2 patients with Koos IV VS who visited our center, the National Reference Center for NF2 Rare Disease in Pitié-Salpétrière Hospital of Paris, between January 2016 and December 2018 were included. Clinical charts, radiology, operative reports, and audiograms were reviewed.

Results: Among 54 NF2 patients with Koos IV VS (mean maximum extrameatal diameter: 34 mm; range:17-62 mm), 27 were operated on for 28 VS; 21 were treated with bevacizumab; and six were observed. In the surgical group, VS resections were gross total, near-total, subtotal, or partial in 32%, 25%, 32%, and 11%, respectively; and a good (House-Brackmann grades I-II) facial nerve function was achieved in 81.5% at 1 year. Hearing was preserved in 14%, 78%, and 66% of the surgical (n = 7), bevacizumab (n = 9), and observation (n = 3) patients, respectively.

Conclusion: All therapeutic options, including surgery and/or bevacizumab and occasionally observation, should be proposed to NF2 patients with large VS in the setting of dedicated centers. A decision-making tree is proposed for Koos IV VS management based on tumor evolution, hearing and clinical status of the patient, and contralateral VS size.

Level Of Evidence: 4, case series study, historically controlled study Laryngoscope, 131:E98-E107, 2021.
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http://dx.doi.org/10.1002/lary.28998DOI Listing
January 2021

Treatment choice in single-sided deafness and asymmetric hearing loss. A prospective, multicentre cohort study on 155 patients.

Clin Otolaryngol 2020 Nov 24. Epub 2020 Nov 24.

Service d'Otologie, Otoneurologie et ORL Pédiatrique, Hôpital Pierre-Paul Riquet, CHU Toulouse Purpan, France.

Objectives: To describe the treatment choice in a cohort of subjects with single-sided deafness (SSD) and asymmetric hearing loss (AHL). To assess the reliability of the treatment trials.

Design: In this national, multicentre, prospective study, the choice of subjects was made after two consecutive trials of Contralateral Routing Of the Signal (CROS) hearing aids and a Bone Conduction Device (BCD) on a headband. Subjects could proceed with one of these two options, opt for cochlear implantation or decline all treatments.

Setting: Seven tertiary university hospitals.

Participants: One hundred fifty-five subjects with SSD or AHL fulfilling the candidacy criteria for cochlear implantation, with or without associated tinnitus.

Main Outcome Measures: After the two trials, the number of subjects choosing each option was described. Repeated assessments of both generic and auditory-specific quality of life were conducted, as well as hearing assessments (speech recognition in noise and horizontal localization).

Results: CROS was chosen by 75 subjects, followed by cochlear implantation (n = 51), BCD (n = 18) and abstention (n = 11). Patients who opted for cochlear implantation had a poorer quality of life (P = .03). The improvement of quality of life indices after each trial was significantly associated with the final treatment choice (P = .008 for generic indices, P = .002 for auditory-specific indices). The follow-up showed that this improvement had been overestimated in the CROS group, with a long-term retention rate of 52.5%.

Conclusions: More than one third of SSD/AHL subjects are unsatisfied after CROS and BCD trials. Repeated quality of life assessments help counselling the patient for his/her treatment choice.
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http://dx.doi.org/10.1111/coa.13672DOI Listing
November 2020

Multinational Appraisal of the Chronic Otitis Media Questionnaire 12 (COMQ-12).

Otol Neurotol 2021 01;42(1):e45-e49

University of Miyazaki, Miyazaki, Japan.

Objectives: The Chronic Otitis Media Questionnaire-12 (COMQ-12) assesses patient-reported health-related quality of life. A multinational collaborative project was performed to translate and appraise the psychometric properties of the COMQ-12 across Europe, Asia, and South America.

Methods: Eight otology units from seven countries (China, Colombia, France, Italy, Japan, Korea, Turkey) created native versions of the COMQ-12 by the process of translation and back-translation. Questionnaire reliability was assessed on the basis of internal consistency by calculating Cronbach's coefficient alpha. Exploratory factor analysis was performed to identify underlying correlations between individual questionnaire items.

Results: This study included 478 participants from 8 countries. Calculated values for Cronbach's coefficient alpha were between 0.71 and 0.90. Exploratory factor analysis allowed the identification of three dominant factors, the primary factor (related to hearing problems) explaining 42% of the total variance, the secondary factor (related to daily activities) explaining 30% of the variance, and the third factor (related to acute disease activity) explaining 28% of the variance.

Conclusions: This is a large study of patients with chronic otitis media, from centers from within many different countries spanning Europe, Asia, and South America. This study supports the use of the COMQ-12 within the individual countries where it was tested.
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http://dx.doi.org/10.1097/MAO.0000000000002845DOI Listing
January 2021

Management of tegmen defects with mastoid and epitympanic obliteration using S53P4 bioactive glass.

Laryngoscope Investig Otolaryngol 2020 Apr 9;5(2):297-304. Epub 2020 Mar 9.

APHP Département d'Otologie, d'implants auditifs et de base du crâne, auditory Groupe Hospitalo-Universitaire Pitié-Salpêtrière Paris France.

Objective: To evaluate the surgical results and complications in a cohort of patients operated on to repair a tegmen bony defect using either transmastoid approach with obliteration using S53P4 bioactive glass granules (TMA-O), or the classic middle cranial fossa approach (MCFA).

Study Design: A retrospective monocentric study.

Methods: Twenty-five cases (24 patients) were included. Data regarding patient demographics, etiology, intraoperative findings, complications, recurrences, audiometric data, and follow-up were analyzed.

Results: Seven patients were operated with MCFA and 17 patients with TMA-O. One patient was operated on using a combined approach (MCFA + TMA-O). In the preoperative HRCT scan, the size of the defect was estimated to be 6 ± 3.8 mm in the TMA-O group and 6 ± 3.5 mm in the MCFA group ( = .969). Intraoperatively, in the MCFA group, the location of the defect was mostly anterior (86%) with an intact ossicular chain (86%). A discontinuous chain was observed in 15 patients (88%) in the TMA-O group. The mean follow-up time was 22 ± 14 months in the TMA-O group and 24 ± 15 months in the MCFA group ( = .762). In both groups, there were no early postoperative complications or recurrences during follow-up.

Conclusion: Repair of a tegmen bony defect with S53P4 bioactive glass granules seems to be safe and effective, limiting the use of the middle cranial fossa approach to cases with epitympanic defects and with an intact ossicular chain, and it could be used whatever the size of the defect and/or the presence of meningoencephalocele.

Level Of Evidence: 4.
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http://dx.doi.org/10.1002/lio2.374DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7178447PMC
April 2020

Management of sporadic vestibular schwannoma with contralateral nonserviceable hearing.

Laryngoscope 2020 06 23;130(6):E407-E415. Epub 2019 Oct 23.

Otorhinolaryngology Department, Unit of Otology, Auditory Implants and Skull Base Surgery, Greater paris university hospitals, Pitié-Salpêtrière University Group Hospital, Paris, France.

Objectives/hypothesis: To outline a possible decision-making process for sporadic vestibular schwannoma (VS) with contralateral nonserviceable hearing at diagnosis.

Study Design: Retrospective case series.

Methods: Diagnosed VS was studied in a tertiary referral center from 1995 to 2013.

Results: Twenty-eight patients were included, with a mean follow-up of 6.9 years (range = 0.5-20 years). Ten were stage 1, 10 were stage 2, five were stage 3, and three were stage 4. Ipsilateral hearing levels were A (n = 3), B (n = 10), C (n = 7) and D (n = 8) American Academy of Otolaryngology-Head and Neck Surgery classification. Contralateral hearing levels were C (n = 11) and D (n = 17). Initial VS management included surveillance (n = 12) or surgery (n = 16), and four patients were later treated with surgery (n = 3) or stereotactic irradiation (n = 1). Hearing was improved by hearing aids and/or etiological treatment (n = 8), restored by contralateral (n = 15) or ipsilateral (n = 4) cochlear implants (CIs), or ipsilateral auditory brainstem implants (ABIs) (n = 3). Finally, 18 CIs were active daily; 14 of them presented high or moderate benefit with mean open-set dissyllabic word scores (WRS) of 58.1% and sentence recognition scores (SRS) of 69.7%, but only one ABI was still active (WRS of 70% and SRS of 87% with lip reading).

Conclusions: When early removal of VS was not necessary, contralateral CI or etiological treatment for hearing loss might be recommended initially. Ipsilateral CI is proposed, whereas VS should be operated on if previous hearing restoration was not successful. ABI should be reserved for the rare cases where a contralateral CI could not be implanted or the cochlear nerve was sectioned during VS removal.

Level Of Evidence: 3 Laryngoscope, 130:E407-E415, 2020.
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http://dx.doi.org/10.1002/lary.28369DOI Listing
June 2020

NF2-Related Intravestibular Schwannomas: Long-Term Outcomes of Cochlear Implantation.

Otol Neurotol 2020 01;41(1):94-99

APHP, GH Pitié-Salpêtrière, Department of Otology, Auditory Implants and Skull Base Surgery, Ile-de-France Reference Center of Cochlear Implant and Auditory Brainstem Implant; Rare Diseases Center of Genetic deafness for adult.

Objective: Intravestibular schwannomas (IVS) are uncommon tumors in Neurofibromatosis type 2 (NF2) and are mainly associated with multiple internal auditory meatus (IAM) and cerebellopontine angle (CPA) tumors. They usually induce profound hearing loss which can be rehabilitated by cochlear implantation (CI). The aim of this study was to analyze the long-term outcomes of CI during the unpredictable evolution of NF2 disease.

Study Design: Retrospective case review.

Setting: Tertiary referral center.

Patients: Three adults with neurofibromatosis type 2 and intravestibular schwannomas, and who were cochlear implant recipients.

Interventions: Periodic radiologic follow-up, tumor resection, and hearing rehabilitation.

Main Outcome Measures: Audiological evolution, tumor evolution, surgical outcome, cochlear implant outcome.

Results: Three NF2 patients (mean age at diagnosis, 26.3 ± 3.2 yr) were identified with IVS in the period between 2000 and 2017. IVS were first observed by serial MRI and profound hearing loss occurred in this ear after 4 ± 1.5 years of follow-up. IVS were removed via a translabyrinthine approach, and ipsilateral cochlear implantations were simultaneously performed. In two patients, large contralateral CPA tumors had previously been removed without hearing preservation, whereas in the third patient, a small, growing contralateral VS was excised via a retrosigmoid approach 6 months after IVS removal/cochlear implantation with serviceable hearing preservation. In all cases, CI provided good hearing outcomes. In two cases, hearing outcomes were even better for more than 5 years when ipsilateral intracanalicular vestibular schwannomas were removed in either the same or subsequent procedures.

Conclusions: Rehabilitation of hearing with CI provides a favorable long-term outcome in patients with NF2-related IVS which could be altered by the occurrence of other intracanalicular and/or CPA NF2-related tumors.
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http://dx.doi.org/10.1097/MAO.0000000000002431DOI Listing
January 2020

Cochlear Implant Electrode Migration due to Cholesterol Granuloma: Cues from a Case.

J Int Adv Otol 2019 Dec;15(3):466-468

Department of Otology, Auditory Implants and Skull Base, Pitié Salpêtrière Hospital, Paris, France.

This paper aims to describe a rare case of cochlear implant (CI) failure due to electrode array migration and review the literature on the topic. A 72-year-old woman complained of retroauricolar pain two years after receiving a left CI, with deterioration of the auditory skills and an increased impedance of electrodes. Temporal bone computed tomographic scans revealed a soft density tissue involving the left mastoid and the middle ear. It also revealed a lateral displacement of the array into the middle ear. Surgery with CI re-implantation was performed. The specimen examination disclosed the presence of a cholesterol granuloma. According to the literature, array migration after CI due to cholesterol granuloma is very rare. When patient's auditory performances decline and electrodes impedance increases, computed tomography (CT) scans should be performed to detect possible electrode issues, as in this case. Middle ear and mastoid cholesterol granuloma represent a possible, rare, cause of electrode array migration, even in absence of cochlear erosions.
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http://dx.doi.org/10.5152/iao.2019.6072DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6937185PMC
December 2019

Benefits of a contralateral routing of signal device for unilateral Naída CI cochlear implant recipients.

Eur Arch Otorhinolaryngol 2019 Aug 17;276(8):2205-2213. Epub 2019 May 17.

Sorbonne Université, Inserm, Unité de Réhabilitation chirurgicale mini-invasive robotisée de l'audition, Paris, France.

Purpose: Many bilaterally deaf adults are only able to receive one cochlear implant (CI), resulting in suboptimal listening performance, especially in challenging listening environments. Adding a contralateral routing of signal (CROS) device to a unilateral CI is one possibility to alleviate these challenges. This study examined the benefit of such a CROS device.

Methods: Thirteen adult subjects with at least 6 months of CI use, and no or limited benefit of a hearing instrument in the contralateral ear were included in the study. The perceived benefit of a CROS device in everyday listening environments was evaluated up to 1 year after initial fitting using several questionnaires. Speech intelligibility performance was determined using the French matrix sentence test in quiet and in two speech-in-noise setups and was followed for 3 months after CROS fitting.

Results: Subjects indicated high satisfaction with the practical usability of the CROS device and long-term device retention was high. Perceived benefits in everyday listening environments were reported. Formal speech intelligibility tests revealed statistically significant median improvements of 6.93 dB SPL (Wilcoxon Z = 2.380, p = 0.017) in quiet and up to 8.00 dB SNR (Wilcoxon Z = 2.366, p = 0.018) in noise. These benefits were accessible immediately without a need for prolonged acclimatization.

Conclusions: Subjective satisfaction and device retention as well as speech intelligibility benefits in quiet and in noise prove the CROS device to be a valuable addition to a unilateral CI in cases of bilateral deafness where bilateral implantation is not an option.
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http://dx.doi.org/10.1007/s00405-019-05467-9DOI Listing
August 2019

Bioactive glass granules for mastoid and epitympanic surgical obliteration: CT and MRI appearance.

Eur Radiol 2019 Oct 19;29(10):5617-5626. Epub 2019 Mar 19.

AP-HP, Neuroradiology department, Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix, 75013, Paris, France.

Purpose: To evaluate the appearance of mastoid and epitympanic obliteration using S53P4 bioactive glass (BG) granules in high-resolution computed tomography (HRCT) and MRI.

Materials And Methods: Patients undergoing mastoid and epitympanic obliteration between May 2013 and December 2015 were prospectively included in an uncontrolled clinical study. All patients underwent a temporal HRCT scan 1 year after surgery, aimed at evaluating the attenuation, homogeneity, and osseointegration of the BG granules, as well as the ventilation of the middle ear and the volume of the obliterated paratympanic spaces. If a cholesteatoma was found during surgery, additional MRI, including at least pre- and post-contrast T1-weighted, T2-weighted, and axial non-echo-planar diffusion-weighted (DW) sequences, was performed 1 year after surgery, to study the normal signal of the BG granules and the presence of residual cholesteatoma and/or other temporal bone pathologies.

Results: Seventy cases were included. On 1-year HRCT, the mean attenuation of the BG granules was 888.34 ± 166.10 HU. The obliteration was found to be mostly homogeneous with partial osseointegration. The appearance of the BG granules having a low-intensity signal in T2-weighted imaging and DW MRI was always different from the appearance of cholesteatoma. A longer follow-up has shown no attenuation or signal modification of the BG granules compared with the 1-year imaging.

Conclusion: Radiological follow-up of patients operated on with mastoid and epitympanic obliteration using BG granules is effective using both HRCT and MRI. A cholesteatoma and/or other potential complications could easily be detected due to the specific radiological appearance of the BG granules.

Key Points: • The appearance of mastoid and epitympanic obliteration by S53P4 bioactive glass (BG) granules on high-resolution computed tomography (HRCT) scans was homogeneous with an attenuation significantly higher than the attenuation of cholesteatoma and lower than mastoid bone attenuation. • The granules have a low-intensity signal on non-echo-planar diffusion-weighted sequences and on T2-weighted images and present contrast enhancement allowing the differential diagnosis with cholesteatoma and effective for the detection of other underlying temporal bone pathologies. • The volume and radiological appearance of the obliteration appear to be stable with time.
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http://dx.doi.org/10.1007/s00330-019-06120-zDOI Listing
October 2019

Pig as a large animal model for posterior fossa surgery in oto-neurosurgery: A cadaveric study.

PLoS One 2019 26;14(2):e0212855. Epub 2019 Feb 26.

Sorbonne Université, Inserm, Unité "Réhabilitation chirurgicale mini-invasive et robotisée de l'audition", Paris, France.

This study proposes a practical model for a new approach to the posterior fossa in common domestic pigs. Several surgical procedures can be simulated in the nonliving pig model, including soft tissue dissection, drilling of temporal bone, dural incision, access to the cerebellopontine angle, exposure of cranial nerves and drilling of the internal auditory canal. The pig model perfectly simulates standard otological and neurosurgical procedures, and we highlight the feasibility of our approach for further experiments in a living pig model with the possibility of reproducing the model for research on cranial nerves in pigs to study their electrophysiological behavior.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0212855PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6391018PMC
November 2019

Positive Impact of Genetic Test on the Management and Outcome of Patients With Paraganglioma and/or Pheochromocytoma.

J Clin Endocrinol Metab 2019 04;104(4):1109-1118

Assistance Publique, Hôpitaux de Paris, Hôpital Cochin, Service d'Endocrinologie, Centre de Référence Maladies Rares de la Surrénale, Paris, France.

Context: Pheochromocytomas and paragangliomas (PPGLs) are characterized by a strong genetic component, with up to 40% of patients carrying a germline mutation in a PPGL susceptibility gene. International guidelines recommend that genetic screening be proposed to all patients with PPGL.

Objective: Our objective was to evaluate how a positive genetic test impacts the management and outcome of patients with SDHx or VHL-related PPGL.

Design: We performed a multicentric retrospective study involving 221 propositi carrying an SDHB, SDHD, SDHC, or VHL germline mutation. Patients were divided into two groups: genetic patients, who were informed of their genetic status within the year following the first PPGL diagnosis, and historic patients, who only benefited from the genetic test several years after initial PPGL diagnosis.

Results: Genetic patients had better follow-up than historic patients, with a greater number of examinations and a reduced number of patients lost to follow-up (9.6% vs 72%, respectively). During follow-up, smaller (18.7 vs 27.6 mm; P = 0.0128) new PPGLs and metastases as well as lower metastatic spread were observed in genetic patients. Of note, these differences were reversed in the historic cohort after genetic testing. Genetic patients who developed metachronous metastases had a better 5-year survival rate than historic patients (P = 0.0127).

Conclusion: Altogether, our data suggest that early knowledge of genetic status had a positive impact on the management and clinical outcome of patients with a germline SDHx or VHL mutation.
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http://dx.doi.org/10.1210/jc.2018-02411DOI Listing
April 2019

Revision stapes surgery: A review of 102 cases.

Clin Otolaryngol 2018 12 25;43(6):1587-1590. Epub 2018 Jul 25.

AP-HP, GHU Pitié-Salpêtrière, Service ORL, Otologie, implants auditifs et chirurgie de la base du crâne, Paris, France.

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http://dx.doi.org/10.1111/coa.13181DOI Listing
December 2018

Fluctuating Hearing Loss in the Only Hearing Ear: Cochlear Implantation in the Contralateral Deaf Side.

Otolaryngol Head Neck Surg 2018 06 20;158(6):1101-1106. Epub 2018 Mar 20.

1 Sorbonne Universités, Université Pierre et Marie Curie Paris 6, Inserm, Unité Réhabilitation chirurgicale mini-invasive et robotisée de l'audition, Paris, France.

Objective To investigate the hearing performance of adult patients presenting unilateral deafness with contralateral fluctuating hearing loss who received a cochlear implant on the deaf side. Study Design Case series with chart review. Setting University tertiary referral center. Subjects and Methods Preoperatively and at 6 and 12 months postoperatively, 23 patients underwent pure tone audiometry and speech audiometry with disyllabic and monosyllabic words in a quiet environment and sentences in quiet and noisy (signal-to-noise ratio +10 dB SPL) environments under best-aided conditions. The Abbreviated Profile of Hearing Aid Benefit (APHAB) inventory was evaluated preoperatively and at 6 and 12 months postoperatively. Results No difference was found between pre- and postoperative tests for disyllabic and monosyllabic words. For sentences in quiet and noisy environments, a difference between pre- and postoperative performance was present at 1 year ( P = .002 and P = .02, respectively). In a noisy environment, a difference was present at 6 and 12 months postoperatively as compared with the preoperative value (mean ± SD: 6 months: 42% ± 7.1% vs 61% ± 6.5%, P = .016). A significant improvement in the APHAB score was found at 6 and 12 months postimplantation (Friedman's 2-way analysis of variance by ranks, P < .001). The number of years of hearing deprivation of the deaf ear was not correlated with performance. Conclusion When incapacitating fluctuating hearing loss occurs in patients presenting a contralateral deaf ear, a cochlear implant is indicated in the latter ear, significantly improving performance in noisy conditions and allowing a better quality of communication to be achieved.
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http://dx.doi.org/10.1177/0194599818763137DOI Listing
June 2018

Potential of Robot-Based Surgery for Otosclerosis Surgery.

Otolaryngol Clin North Am 2018 Apr;51(2):475-485

Sorbonne Université, Inserm, UMR-S 1159 "Minimally Invasive Robot-based Hearing Rehabilitation", 16 Rue Henri Huchard, 75018 Paris, France; Otolaryngology Department, Unit of Otology, Auditory Implants and Skull Base Surgery, AP-HP, GHU Pitié-Salpêtrière, 43 bd de l'hôpital, 75013 Paris, France.

Otosclerosis surgery is performed through a transcanal approach and requires long, thin instruments with submillimetric precision and precise amplitude of motion. The functional outcomes and complications of otosclerosis surgery depend on the experience of the surgeon. Thus, any technological assistance that can enhance the surgeon's dexterity and rapidly reduce the learning curve could yield an even safer surgical procedure. One of the options is to use robotic assistance to achieve this goal. An overview of different robots designed for otosclerosis surgery is presented focusing on the RobOtol system that we have designed as a multitask platform for ear surgery.
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http://dx.doi.org/10.1016/j.otc.2017.11.016DOI Listing
April 2018

3D endoscopic ear surgery: a clinical pilot study.

Eur Arch Otorhinolaryngol 2018 Feb 5;275(2):379-384. Epub 2017 Dec 5.

AP-HP, GHU Pitié-Salpêtrière, Service ORL, Otologie, implants auditifs et chirurgie de la base du crâne, 50/52 Bd Vincent Auriol, 75013, Paris, France.

Objective: To evaluate the feasibility and efficacy of a new high-resolution 3D endoscope in endoscopic ear and lateral skull base surgery.

Methods: Eight patients, five women and three men, were included in this clinical pilot prospective study. Their age was 38 ± 17.3 years (mean ± SD, range 17-54 years). The right side was involved in five cases, and the left side in three cases. There were three cases of chronic otitis, one case of cholesteatoma of the external auditory canal, one case of otosclerosis, one case of cochlear implant surgery, and two cases of stage 2 vestibular schwannoma operated on with a retrosigmoid approach to preserve hearing.

Results: There were no intraoperative or postoperative complications. The new system was used during all procedures without the necessity to switch to a 2D mode. The surgeons felt comfortable using the system and its major advantages were considered to be in measuring the distances for ossicular chain reconstruction and in the sense of depth provided in the middle ear and cerebellopontine angle.

Conclusion: The sense of depth provided by the 3D system is effective in both middle ear and lateral skull base surgery. Further improvements (smaller and/or more angled endoscopes) should be considered for future developments in endoscopic ear surgery.
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http://dx.doi.org/10.1007/s00405-017-4839-6DOI Listing
February 2018

Cochlear Implant Insertion Axis Into the Basal Turn: A Critical Factor in Electrode Array Translocation.

Otol Neurotol 2018 02;39(2):168-176

Sorbonne Universités, Université Pierre et Marie Curie Paris 6, Inserm, Unité "Réhabilitation chirurgicale mini-invasive et robotisée de l'audition".

Hypothesis: An inappropriate insertion axis leads to intracochlear trauma during cochlear implantation (CI).

Background: Few studies assessed the relationship between the insertion axis and the electrode scalar location.

Methods: Preimplantation cone-beam CT (CBCT) was performed on 12 human temporal bones. In five temporal bones, an optimal insertion axis was planned, due to the impossibility to attain the ST centerline from the posterior tympanotomy, because of facial canal position. In the seven other temporal bones, an inaccurate insertion axis was intentionally planned (optimal axis+15 degrees). Automated CI array insertion according to the planned axis was performed with a motorized insertion tool driven by a navigated robot-based arm. The cochlea and basilar membrane were segmented from the preimplantation CBCT and the array segmented from the postimplantation CBCT to construct a merged final three-dimensional (3D) model. Microscopical and 3D analysis were performed to determine the intracochlear trauma at the level of each electrode.

Results: A good agreement was observed in determining electrode position between microscopic analysis and the 3D model (Cohen's kappa k = 0.67). The angle of approach to the ST centerline was associated with the number of electrodes inserted into the ST (r = -0.65, p = 0.02, [95% CI -0.90 to -0.11] Spearman's rank correlation).

Conclusion: A 3D reconstruction model was effective in determining the array position in the cochlea scalae. Our data indicate that the angle of approach to the ST centerline is a critical factor in intracochlear trauma. Additional studies should be conducted to assess the importance of the insertion axis with other array designs.
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http://dx.doi.org/10.1097/MAO.0000000000001648DOI Listing
February 2018

Does the diameter of the stapes prosthesis really matter? A prospective clinical study.

Laryngoscope 2018 08 24;128(8):1922-1926. Epub 2017 Nov 24.

Department of Otolaryngology, Unit of Otology, Auditory implants and Skull base surgery, Public Assistance-Paris Hospital, Pitié-Salpêtrière Group Hospital, Paris, France.

Objectives/hypothesis: To evaluate the influence of the diameter of stapes prosthesis on functional outcomes in stapes surgery.

Study Design: Prospective cohort study.

Methods: Fifty consecutive small fenestra stapedotomies performed using a 0.4-mm-diameter prosthesis were compared with 50 consecutive small fenestra stapedotomies carried out using a 0.6-mm-diameter piston. Audiological assessment following the recommendations of the Committee on Hearing and Equilibrium was performed 1 month after surgery. Postoperative complications between the two groups were noted.

Results: There were no statistically significant differences in demographic data between the two groups, and no differences in preoperative bone-conduction (BC) or air-conduction (AC) hearing thresholds for all frequencies (analysis of variance [ANOVA] and χ tests). No differences were found in the mean preoperative BC and AC pure-tone average and air-bone gap (ABG). In the postoperative evaluation, a statistically significant difference was found for the mean AC gain (20 ± 8.7 vs. 24 ± 11.5, P = .042, ANOVA) as well as for the postoperative AC threshold at 0.125 and 0.25 kHz and the postoperative BC threshold at 0.25 kHz (P < .01, ANOVA). A postoperative ABG ≤10 dB was obtained in 90% and 94% of patients in the 0.4-mm- and 0.6-mm-diameter piston groups, respectively (difference not significant, χ test). No postoperative dead ear and/or sensorineural hearing loss was noted in either group.

Conclusions: The 0.6-mm piston allowed a statistically significant higher AC gain compared with the 0.4-mm diameter piston. A larger diameter piston may be preferable if there are no anatomical or technical reasons that would favor a smaller prosthesis.

Level Of Evidence: 2b Laryngoscope, 1922-1926, 2018.
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http://dx.doi.org/10.1002/lary.27021DOI Listing
August 2018

Spontaneously Resolving Symptomatic Subdural Hygromas After Cerebellopontine Angle Tumor Surgery.

World Neurosurg 2018 02 31;110:35-38. Epub 2017 Oct 31.

Department of Neurosurgery, Groupe Hospitalier Pitié-Salpêtrière, APHP, Paris, France; Université Paris VI-Pierre et Marie Curie, Paris, France.

Background: Subdural hygroma is a rare disease most commonly encountered in posttraumatic patients. Even more rarely, it has been described as a complication of cerebellopontine angle tumor requiring surgical evacuation.

Case Description: This report discusses 2 patients who underwent surgery for cerebellopontine angle tumor and who both developed symptomatic subdural hygromas a few days later. Both became highly symptomatic but symptoms resolved spontaneously and promptly before planned surgery.

Conclusions: These 2 cases highlight the 2 principal pathogenesis theories for the development of subdural hygromas (arachnoid tear and effusion) and suggest a theory for their sudden and spontaneous resolution: the pressure equilibrium opening the valve created by the arachnoid tear. Eventhough surgical treatment remains the recommended attitude, these cases show that conservative treatment can be an option in some cases.
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http://dx.doi.org/10.1016/j.wneu.2017.10.114DOI Listing
February 2018

Benefit of the UltraZoom beamforming technology in noise in cochlear implant users.

Eur Arch Otorhinolaryngol 2017 Sep 29;274(9):3335-3342. Epub 2017 Jun 29.

Sorbonne Universités, Université Pierre et Marie Curie Paris 6, Inserm, Unité Réhabilitation chirurgicale mini-invasive et robotisée de l'audition, Paris, France.

The objectives of the study were to demonstrate the audiological and subjective benefits of the adaptive UltraZoom beamforming technology available in the Naída CI Q70 sound processor, in cochlear-implanted adults upgraded from a previous generation sound processor. Thirty-four adults aged between 21 and 89 years (mean 53 ± 19) were prospectively included. Nine subjects were unilaterally implanted, 11 bilaterally and 14 were bimodal users. The mean duration of cochlear implant use was 7 years (range 5-15 years). Subjects were tested in quiet with monosyllabic words and in noise with the adaptive French Matrix test in the best-aided conditions. The test setup contained a signal source in front of the subject and three noise sources at +/-90° and 180°. The noise was presented at a fixed level of 65 dB SPL and the level of speech signal was varied to obtain the speech reception threshold (SRT). During the upgrade visit, subjects were tested with the Harmony and with the Naída CI sound processors in omnidirectional microphone configuration. After a take-home phase of 2 months, tests were repeated with the Naída CI processor with and without UltraZoom. Subjective assessment of the sound quality in daily environments was recorded using the APHAB questionnaire. No difference in performance was observed in quiet between the two processors. The Matrix test in noise was possible in the 21 subjects with the better performance. No difference was observed between the two processors for performance in noise when using the omnidirectional microphone. At the follow-up session, the median SRT with the Naída CI processor with UltraZoom was -4 dB compared to -0.45 dB without UltraZoom. The use of UltraZoom improved the median SRT by 3.6 dB (p < 0.0001, Wilcoxon paired test). When looking at the APHAB outcome, improvement was observed for speech understanding in noisy environments (p < 0.01) and in aversive situations (p < 0.05) in the group of 21 subjects who were able to perform the Matrix test in noise and for speech understanding in noise (p < 0.05) in the group of 13 subjects with the poorest performance, who were not able to perform the Matrix test in noise. The use of UltraZoom beamforming technology, available on the new sound processor Naída CI, improves speech performance in difficult and realistic noisy conditions when the cochlear implant user needs to focus on the person speaking at the front. Using the APHAB questionnaire, a subjective benefit for listening in background noise was also observed in subjects with good performance as well as in those with poor performance. This study highlighted the importance of upgrading CI recipients to new technology and to include assessment in noise and subjective feedback evaluation as part of the process.
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http://dx.doi.org/10.1007/s00405-017-4651-3DOI Listing
September 2017

Modifications to a 3D-printed temporal bone model for augmented stapes fixation surgery teaching.

Eur Arch Otorhinolaryngol 2017 Jul 24;274(7):2733-2739. Epub 2017 Apr 24.

Sorbonne Universités, Université Pierre et Marie Curie Paris 6, Inserm, UMR-S 1159 "Minimally Invasive Robot-based Hearing Rehabilitation", Paris, France.

Functional outcomes and complications in otosclerosis surgery are governed by the surgeon's experience. Thus, teaching the procedure to residents to guide them through the learning process as quickly as possible is challenging. Artificial 3D-printed temporal bones are replacing cadaver specimens in many institutions to learn mastoidectomy, but these are not suitable for middle ear surgery training. The goal of this work was to adapt such an artificial temporal bone to aid the teaching of otosclerosis surgery and to evaluate this tool. We have modified a commercially available 3D-printed temporal bone by replacing the incus and stapes of the model with in-house 3D-printed ossicles. The incus could be attached to a 6-axis force sensor. The stapes footplate was fenestrated and attached to a 1-axis force sensor. Six junior surgeons (residents) and seven senior surgeons (fellows or consultants) were enrolled to perform piston prosthesis placement and crimping as performed during otosclerosis surgery. The time required to perform the tasks and the forces applied to the incus and stapes were collected and analyzed. No statistically significant differences were observed between the junior and senior groups for time taken to perform the tasks and the forces applied to the incus during crimping and placement of the prosthesis. However, significantly lower forces were applied to the stapes by the senior surgeons in comparison with the junior surgeons during prosthesis placement (junior vs senior group, 328 ± 202.9 vs 80 ± 99.6 mN, p = 0.008) and during prosthesis crimping (junior vs senior group, 565 ± 233 vs 66 ± 48.6 mN, p = 0.02). We have described a new teaching tool for otosclerosis surgery based on the modification of a 3D-printed temporal bone to implement force sensors on the incus and stapes. This tool could be used as a training tool to help the residents to self-evaluate their progress with recording of objective measurements.
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http://dx.doi.org/10.1007/s00405-017-4572-1DOI Listing
July 2017

Imaging Criteria to Predict Surgical Difficulties During Stapes Surgery.

Otol Neurotol 2017 07;38(6):815-821

*Otorhinolaryngology, Creteil Hospital, Creteil †Radiology Department ‡Biostatistic, Public Health and Medical Information Department §Otorhinolaryngology Assistance Publique des Hôpitaux de Paris (APHP), Pitié Salpêtrière University Hospital ||Sorbonne University, UPMC univ Paris 6 ¶National Institute of Health and Medical Research Pierre and Marie Curie University (UPMC INSERM), UMR S-1159, Minimally Invasive Robot-based Hearing Rehabilitation #Brain and Spine Institute, Magnetoencephalography-Electroencephalography Center (MEG-EEG Center) (UMR 7225/U1127), Pierre and Marie Curie University (UPMC)/National Center of Scientific Research (CNRS)/National Institute of Health and Medical Research (INSERM), Paris, France.

Background And Purpose: Stapes surgery for otosclerosis can be challenging if access to the oval window niche is restricted. The aim of this study was to determine the accuracy of the computed tomographic (CT) scan in the evaluation of anatomical distances, and to analyze its reliability in predicting surgical technical difficulties.

Material And Methods: A total of 96 patients (101 ears) were enrolled in a prospective study between 2012 and May 2015. During surgery, we evaluated the distance D1 between the stapes and the facial nerve, distance D2 between the promontory and the facial nerve after ablation of the superstructure, and the intraoperative discomfort of the surgeon. On preoperative CT scans, we measured the width and depth of the oval window niche, and the angle formed by two axes starting from the center-point of the footplate, the first tangential to the superior wall of the promontory, and the second tangential to the inferior wall of the fallopian canal.

Results: Intraoperative distances D1 and D2 were correlated with the width of the oval window and with the facial-promontory angle measured on imaging. CT scan measurements of the facial-promontory angle and width of the oval window were associated with the degree of discomfort of the surgeon. The cut-off threshold for intraoperative subjective discomfort was computed as 1.1 mm for the width of the oval window niche, with a sensibility of 71% and a specificity of 84%.

Conclusion: Preoperative imaging analysis of the oval window width and the facialpromontory angle can predict operative difficulty in otosclerosis surgery.
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http://dx.doi.org/10.1097/MAO.0000000000001417DOI Listing
July 2017

Role of electrophysiology in guiding near-total resection for preservation of facial nerve function in the surgical treatment of large vestibular schwannomas.

J Neurosurg 2018 03 14;128(3):903-910. Epub 2017 Apr 14.

2Sorbonne Universités, UPMC Université Paris VI; and.

OBJECTIVE In large vestibular schwannoma (VS) surgery, the facial nerve (FN) is at high risk of injury. Near-total resection has been advocated in the case of difficult facial nerve dissection, but the amount of residual tumor that should be left and when dissection should be stopped remain controversial factors. The objective of this study was to report FN outcome and radiological results in patients undergoing near-total VS resection guided by electromyographic supramaximal stimulation of the FN at the brainstem. METHODS This study was a retrospective analysis of a prospectively maintained database. Inclusion criteria were surgical treatment of a large VS during 2014, normal preoperative FN function, and an incomplete resection due to the strong adherence of the tumor to the FN and the loss of around 50% of the response of supramaximal stimulation of the proximal FN at 2 mA. Facial nerve function and the amount and evolution of the residual tumor were evaluated by clinical examination and by MRI at a mean of 5 days postoperatively and at 1 year postoperatively. RESULTS Twenty-five patients met the inclusion criteria and were included in the study. Good FN function (Grade I or II) was observed in 16 (64%) and 21 (84%) of the 25 patients at Day 8 and at 1 year postoperatively, respectively. At the 1-year follow-up evaluation (n = 23), 15 patients (65%) did not show growth of the residual tumor, 6 patients (26%) had regression of the residual tumor, and only 2 patients (9%) presented with tumor progression. CONCLUSIONS Near-total resection guided by electrophysiology represents a safe option in cases of difficult dissection of the facial nerve from the tumor. This seems to offer a good compromise between the goals of preserving facial nerve function and achieving maximum safe resection.
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http://dx.doi.org/10.3171/2016.11.JNS161737DOI Listing
March 2018

Multivariate Analysis of Factors Influencing Facial Nerve Outcome following Microsurgical Resection of Vestibular Schwannoma.

Otolaryngol Head Neck Surg 2017 03 16;156(3):525-533. Epub 2016 Nov 16.

1 Unit of Otology, Auditory Implants and Skull Base Surgery, Otorhinolaryngology Department, Pitié-Salpêtrière Hospital, AP-HP, Paris, France.

Objective To assess through multivariate analysis the clinical pre- and intraoperative factors of facial nerve outcomes at day 8 and 1-year recovery of facial palsy, as compared with day 8 status among patients who underwent total resection of unilateral vestibular schwannoma. Study Design Case series with chart review. Setting Tertiary referral center. Subjects and Methods This study included 229 patients with preoperative normal facial function and anatomic preservation of the facial nerve. Clinical, radiologic, and intraoperative factors were assessed according to facial nerve function at day 8 and 1 year. Results We observed that 74% and 84% of patients had good facial function (House-Brackmann [HB] I-II) at day 8 and 1 year, respectively. Of 60 patients, 26 (43%) who had impaired facial function (HB III-VI) at day 8 recovered good facial function (HB I-II) 1 year after surgery. A structured equation model showed that advanced tumor stage and strong facial nerve adhesion were independently associated with facial nerve conduction block at day 8. No predictive factor of impaired facial function recovery was seen at 1 year. In terms of the extracanalicular diameter of the tumor, the cutoff point to minimize the risk of impaired facial function was 16 mm. Conclusion At day 8 after vestibular schwannoma resection, facial function was impaired in the case of large tumors or strong facial nerve adhesion to the tumor. After 1 year, less than half of the patients recovered good facial function, and no predictive factor was found to be associated with this possible recovery.
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http://dx.doi.org/10.1177/0194599816677711DOI Listing
March 2017

Cone beam computed tomography and histological evaluations of a straight electrode array positioning in temporal bones.

Acta Otolaryngol 2017 Mar 22;137(3):229-234. Epub 2016 Sep 22.

a AP-HP, Groupe Hospitalier Pitié-Salpétrière, Unité d'Otologie , Implants Auditifs et Chirurgie de la base du crâne, Service ORL , Paris , France.

Conclusion: CBCT allows a precise evaluation of the dimensions and of the shape of the cochlear duct that is of primary importance for the choice of the length and the design of the electrode array. This radio-histological study confirms that CBCT is a reliable tool to be used in clinical studies to evaluate the position of straight electrode arrays within the cochlear scala.

Objective: To validate the reliability of cone beam computed tomography (CBCT) in the evaluation of cochlear anatomy and positioning of a straight electrode array, by comparing radiological images to histological analysis of cochlear implanted temporal bones.

Methods: Eight temporal bones for four subjects were analysed before and after cochlear implantation with a straight electrode array. The size of the cochlea, the dimensions, and shape of the cochlear duct at 180° and 360° were evaluated on CBCT performed before implantation. Temporal bones then underwent histological analysis to determine the position of the electrode array. Scalar localization of the electrode array was assessed on CBCT performed after implantation, and compared with histological study.

Results: CBCT is a reliable radiological technique to differentiate variability not only of cochlear dimensions, but also of size and shape of the cochlea. Histological analysis confirmed the scalar position of the electrode array assessed by the CBCT in 7/8 temporal bones, but soft tissue trauma such as dissection of the spiral ligament was not identified by the CBCT.
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http://dx.doi.org/10.1080/00016489.2016.1227477DOI Listing
March 2017

Damage to inner ear structure during cochlear implantation: Correlation between insertion force and radio-histological findings in temporal bone specimens.

Hear Res 2017 02 5;344:90-97. Epub 2016 Nov 5.

Sorbonne Universités, Université Pierre et Marie Curie Paris 6, Inserm, Unité Réhabilitation chirurgicale mini-invasive et robotisée de l'audition, Paris, France; AP-HP, GHU Pitié-Salpêtrière, Service ORL, Otologie, implants auditifs et chirurgie de la base du crâne, Paris, France.

Cochlear implant insertion should be as least traumatic as possible in order to reduce trauma to the cochlear sensory structures. The force applied to the cochlea during array insertion should be controlled to limit insertion-related damage. The relationship between insertion force and histological traumatism remains to be demonstrated. Twelve freshly frozen cadaveric temporal bones were implanted with a long straight electrodes array through an anterior extended round window insertion using a motorized insertion tool with real-time measurement of the insertion force. Anatomical parameters, measured on a pre-implantation cone beam CT scan, position of the array and force metrics were correlated with post-implantation scanning electron microscopy images and histological damage assessment. An atraumatic insertion occurred in six cochleae, a translocation in five cochleae and a basilar membrane rupture in one cochlea. The translocation always occurred in the 150- to 180-degree region. In the case of traumatic insertion, different force profiles were observed with a more irregular curve arising from the presence of an early peak force (30 ± 18.2 mN). This corresponded approximately to the first point of contact of the array with the lateral wall of the cochlea. Atraumatic and traumatic insertions had significantly different force values at the same depth of insertion (p < 0.001, two-way ANOVA), and significantly different regression lines (y = 1.34x + 0.7 for atraumatic and y = 3.37x + 0.84 for traumatic insertion, p < 0.001, ANCOVA). In the present study, the insertion force was correlated with the intracochlear trauma. The 150- to 180-degree region represented the area at risk for scalar translocation for this straight electrodes array. Insertion force curves with different sets of values were identified for traumatic and atraumatic insertions; these values should be considered during motorized insertion of an implant so as to be able to modify the insertion parameters (e.g axis of insertion) and facilitate preservation of endocochlear structures.
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http://dx.doi.org/10.1016/j.heares.2016.11.002DOI Listing
February 2017

Early functional results using the nitibond prosthesis in stapes surgery.

Acta Otolaryngol 2017 Mar 4;137(3):259-264. Epub 2016 Nov 4.

a Service d'Oto-Rhino-Laryngologie, département d'Otologie, Implants auditifs et Chirurgie de la base du crâne , AP-HP, Groupe hospitalier Pitié-Salpêtrière , Paris , France.

Conclusion: The NiTiBOND prosthesis allows early results to be obtained similar to those with a manually crimped prosthesis fitted by experienced surgeons, thus reducing the learning curve in this critical step of the procedure.

Objective: To analyze the 1-month results using the nitinol NiTiBOND prosthesis in primary otosclerosis surgery and to compare the results with those obtained with fully fluoroplastic or fully titanium pistons.

Materials And Methods: Fifty consecutive cases operated on with the NiTiBOND prosthesis (nitinol group) were compared with 50 cases operated on with a fully fluoroplastic piston (fluoroplastic group), and with 131 cases operated on with a fully titanium piston (first titanium group), and also with 50 cases operated on with the same titanium piston just before using the NiTiBOND piston (last titanium group). Pure-tone and speech audiometry was performed 1 month after surgery for the nitinol group. Comparison was made between the early hearing results of the four groups.

Results: The mean air-bone gap closure for the nitinol group was 16 ± 1.0 dB (mean ± SEM, n = 50); an air-bone gap of <15 dB and <10 dB was obtained in 100% and 84% of cases, respectively. These hearing results were similar to the last titanium group and significantly better than those observed in the fluoroplastic and first titanium groups.
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http://dx.doi.org/10.1080/00016489.2016.1247499DOI Listing
March 2017