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1.
Histopathology ; 2024 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-38923026

RESUMO

AIMS: Low-grade non-intestinal-type sinonasal adenocarcinoma (LGSNAC) is a rare heterogeneous and poorly characterised group of tumours, distinct from intestinal- and salivary-type neoplasms. Therefore, further characterisation is needed for clearer biological understanding and classification. METHODS AND RESULTS: Clinical, histological and molecular characterisation of four cases of biphasic, low-grade adenocarcinomas of the sinonasal tract was performed. All patients were male, aged between 48 and 78 years, who presented with polypoid masses in the nasal cavity. Microscopically, virtually all tumours were dominated by tubulo-glandular biphasic patterns, microcystic, focal (micro)papillary, oncocytic or basaloid features. Immunohistochemical staining confirmed biphasic differentiation with an outer layer of myoepithelial cells. Molecular profiling revealed HRAS (p.G13R, p.Q61R) mutations, and concomitant AKT1 (p.E17K, p.Q79R) mutations in two cases. Two cases showed potential in-situ/precursor lesions adjacent to the tumour. Follow-up periods ranged from 1 to 30 months, with one case relapsing locally after 12 and > 20 years. CONCLUSION: This study further corroborates a distinct biphasic low-grade neoplasm of the sinonasal tract with seromucinous differentiation. Although morphological and molecular features overlap with salivary gland epithelial-myoepithelial carcinoma, several arguments favour categorising these tumours within the spectrum of LGSNAC.

2.
Otol Neurotol ; 45(4): e271-e280, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38346807

RESUMO

OBJECTIVES: The aim of this study is to improve our understanding of the mechanics involved in the insertion of lateral wall cochlear implant electrode arrays. DESIGN: A series of 30 insertion experiments were conducted by three experienced surgeons. The experiments were carried out in a previously validated artificial temporal bone model according to established soft surgery guidelines. The use of an in vitro setup enabled us to comprehensively evaluate relevant parameters, such as insertion force, intracochlear pressure, and exact electrode array position in a controlled and repeatable environment. RESULTS: Our findings reveal that strong intracochlear pressure transients are more frequently caused during the second half of the insertion, and that regrasping the electrode array is a significant factor in this phenomenon. For choosing an optimal insertion speed, we show that it is crucial to balance slow movement to limit intracochlear stress with short duration to limit tremor-induced pressure spikes, challenging the common assumption that a slower insertion is inherently better. Furthermore, we found that intracochlear stress is affected by the order of execution of postinsertion steps, namely sealing the round window and posterior tympanotomy with autologous tissue and routing of the excess cable into the mastoid cavity. Finally, surgeons' subjective estimates of physical parameters such as speed, smoothness, and resistance did not correlate with objectively assessed measures, highlighting that a thorough understanding of intracochlear mechanics is essential for an atraumatic implantation. CONCLUSION: The results presented in this article allow us to formulate evidence-based surgical recommendations that may ultimately help to improve surgical outcome and hearing preservation in cochlear implant patients.


Assuntos
Implante Coclear , Implantes Cocleares , Humanos , Implante Coclear/métodos , Cóclea/cirurgia , Janela da Cóclea/cirurgia , Osso Temporal/cirurgia , Eletrodos Implantados
3.
Eur Arch Otorhinolaryngol ; 281(1): 67-74, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37378725

RESUMO

OBJECTIVE: To evaluate the long-term outcomes of trans-mastoid plugging of superior semicircular canal dehiscence (SSCD), focusing on complicated cases. METHODS: In this cohort study, we included all patients who underwent trans-mastoid plugging of SSCD between 2009 and 2019. We evaluated the symptoms (autophony, sound-/pressure-induced vertigo, disequilibrium, aural fullness and pulsatile tinnitus) before and 1 year after surgery in the medical records. We systematically assessed the current symptoms 6.2 ± 3 years postoperative (range 2.2-12.3 years) using questionnaires sent by post and validated by telephone interviews. We also documented any complications and the need for further procedures. We compared pure tone and speech audiometry before and 1 year after surgery. Finally, the degree of mastoid pneumatisation and mastoid tegmen anatomy were reviewed on preoperative CT scans. RESULTS: We included 24 ears in 23 patients. No complications were recorded, and none required a second procedure for SSCD. Following surgery, oscillopsia and Tullio phenomena resolved in all patients. Hyperacusis, autophony, and aural fullness were also settled in all patients except one. Balance impairment persisted to some degree in 35% of patients. No deterioration over the years was reported regarding the above symptoms. On average, bone conduction pure tone average pre- and 1 year postoperative were 13.7 ± 17 and 20.5 ± 18 dB, respectively (P = 0.002). Air bone gaps were reduced from 12.7 ± 8 to 5.9 ± 6 (P = 0.001). Two patients had a significant sclerotic mastoid, three had a prominent low-lying mastoid tegmen, and two had both. Anatomy had no effect on outcome. CONCLUSION: Trans-mastoid plugging of SSCD is a reliable and effective technique which achieves long-lasting symptom control, even in cases with sclerotic mastoid or low-lying mastoid tegmen.


Assuntos
Processo Mastoide , Deiscência do Canal Semicircular , Humanos , Processo Mastoide/diagnóstico por imagem , Processo Mastoide/cirurgia , Estudos de Coortes , Deiscência do Canal Semicircular/complicações , Seguimentos , Estudos Retrospectivos , Vertigem/etiologia , Canais Semicirculares/diagnóstico por imagem , Canais Semicirculares/cirurgia
4.
Front Surg ; 10: 1293616, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38098476

RESUMO

Introduction: An optimal placement of bone conduction implants can provide more efficient mechanical transmission to the cochlea if placed in regions with greater bone column density. The aim of this study was to test this hypothesis and to determine the clinical potential of preoperative bone column density assessment for optimal implant placement. Methods: Five complete cadaver heads were scanned with quantitative computed tomography imaging to create topographic maps of bone density based on the column density index (CODI). Laser Doppler vibrometry was used to measure cochlear promontory acceleration under bone conduction stimulation in different locations on the temporal bone, using a bone-anchored hearing aid transducer at frequencies ranging from 355 Hz to 10 kHz. Results: We found a statistically significant association between CODI levels and the accelerance of the cochlear promontory throughout the frequency spectrum, with an average increase of 0.6 dB per unit of CODI. The distance between the transducer and the cochlear promontory had no statistically significant effect on the overall spectrum. Discussion: We highlight the importance of bone column density in relation to the mechanical transmission efficiency of bone conduction implants. It may be worthwhile to consider column density in preoperative planning in clinical practice.

5.
Front Neurol ; 14: 1231403, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37745650

RESUMO

Aim: This study aimed to compare the effectiveness of auditory brainstem response (ABR) and extracochlear electrocochleography (ECochG) in objectively evaluating the coupling efficiency of floating mass transducer (FMT) placement during active middle ear implant (AMEI) surgery. Methods: We enrolled 15 patients (mean age 58.5 ± 19.4 years) with mixed hearing loss who underwent AMEI implantation (seven ossicular chain and eight round window couplings). Before the surgical procedure, an audiogram was performed. We utilized a clinical measurement system to stimulate and record intraoperative ABR and ECochG recordings. The coupling efficiency of the VSB was evaluated through ECochG and ABR threshold measurements. Postoperatively, we conducted an audiogram and a vibrogram. Results: In all 15 patients, ABR threshold testing successfully determined intraoperative coupling efficiency, while ECochG was successful in only eight patients. In our cohort, ABR measurements were more practical, consistent, and robust than ECochG measurements. Coupling efficiency, calculated as the difference between vibrogram thresholds and postoperative bone conduction thresholds, was found to be more accurately predicted by ABR measurements (p = 0.016, R2 = 0.37) than ECochG measurements (p = 0.761, R2 = 0.02). We also found a non-significant trend toward better results with ossicular chain coupling compared to round window coupling. Conclusion: Our findings suggest that ABR measurements are more practical, robust, and consistent than ECochG measurements for determining coupling efficiency during FMT placement surgery. The use of ABR measurements can help to identify the optimal FMT placement, especially with round window coupling. Finally, we offer normative data for both techniques, which can aid other clinical centers in using intraoperative monitoring for AMEI placement.

6.
Ear Hear ; 44(6): 1379-1388, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37157125

RESUMO

OBJECTIVES: Reliable determination of cochlear implant electrode positions shows promise for clinical applications, including anatomy-based fitting of audio processors or monitoring of electrode migration during follow-up. Currently, electrode positioning is measured using radiography. The primary objective of this study is to extend and validate an impedance-based method for estimating electrode insertion depths, which could serve as a radiation-free and cost-effective alternative to radiography. The secondary objective is to evaluate the reliability of the estimation method in the postoperative follow-up over several months. DESIGN: The ground truth insertion depths were measured from postoperative computed tomography scans obtained from the records of 56 cases with an identical lateral wall electrode array. For each of these cases, impedance telemetry records were retrieved starting from the day of implantation up to a maximum observation period of 60 mo. Based on these recordings, the linear and angular electrode insertion depths were estimated using a phenomenological model. The estimates obtained were compared with the ground truth values to calculate the accuracy of the model. RESULTS: Analysis of the long-term recordings using a linear mixed-effects model showed that postoperative tissue resistances remained stable throughout the follow-up period, except for the two most basal electrodes, which increased significantly over time (electrode 11: ~10 Ω/year, electrode 12: ~30 Ω/year). Inferred phenomenological models from early and late impedance telemetry recordings were not different. The insertion depth of all electrodes was estimated with an absolute error of 0.9 mm ± 0.6 mm or 22° ± 18° angle (mean ± SD). CONCLUSIONS: Insertion depth estimations of the model were reliable over time when comparing two postoperative computed tomography scans of the same ear. Our results confirm that the impedance-based position estimation method can be applied to postoperative impedance telemetry recordings. Future work needs to address extracochlear electrode detection to increase the performance of the method.


Assuntos
Implante Coclear , Implantes Cocleares , Humanos , Impedância Elétrica , Reprodutibilidade dos Testes , Cóclea/cirurgia , Implante Coclear/métodos
7.
IEEE Trans Biomed Eng ; 70(11): 3137-3146, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37195836

RESUMO

Electrocochleography (ECochG) is increasingly used to monitor the inner ear function of cochlear implant (CI) patients during surgery. Current ECochG-based trauma detection shows low sensitivity and specificity and depends on visual analysis by experts. Trauma detection could be improved by including electric impedance data recorded simultaneously with the ECochG. However, combined recordings are rarely used because the impedance measurements produce artifacts in the ECochG. In this study, we propose a framework for automated real-time analysis of intraoperative ECochG signals using Autonomous Linear State-Space Models (ALSSMs). We developed ALSSM based algorithms for noise reduction, artifact removal, and feature extraction in ECochG. Feature extraction includes local amplitude and phase estimations and a confidence metric over the presence of a physiological response in a recording. We tested the algorithms in a controlled sensitivity analysis using simulations and validated them with real patient data recorded during surgeries. The results from simulation data show that the ALSSM method provides improved accuracy in the amplitude estimation together with a more robust confidence metric of ECochG signals compared to the state-of-the-art methods based on the fast Fourier transform (FFT). Tests with patient data showed promising clinical applicability and consistency with the findings from the simulations. We showed that ALSSMs are a valid tool for real-time analysis of ECochG recordings. Removal of artifacts using ALSSMs enables simultaneous recording of ECochG and impedance data. The proposed feature extraction method provides the means to automate the assessment of ECochG. Further validation of the algorithms in clinical data is needed.

8.
IEEE Trans Biomed Eng ; 70(3): 860-866, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36063524

RESUMO

OBJECTIVE: In conventional cochlear implantation, the insertion of the electrode array is strongly affected by the local anatomy and human kinematics. Herein, we present a concept for an insertion tool that allows to optimize the insertion trajectory beyond anatomical constraints and stabilizes the electrode array in manual implantation. A novel sleeve-based design allows the instrument to be compliant and potentially protective to intracochlear structures, while a tear-open mechanism allows it to be removed after insertion by simply retracting the tool. METHODS: Conventional and tool-guided manual insertions were performed by expert cochlear implant surgeons in an analog temporal bone model that allows to simultaneously record intracochlear pressure, insertion forces and electrode array deformation. RESULTS: Comparison between conventional and tool-guided insertions demonstrate a substantial reduction of maximum insertion forces, force variations, transverse intracochlear electrode array movement, and pressure transients. CONCLUSION: The presented tool can be utilized in manual cochlear implantation and significantly improves key metrics associated with intracochlear trauma. SIGNIFICANCE: The instrument may ultimately help improve hearing outcomes in cochlear implantation. The versatile design may be used in both manual cochlear implantation and motorized and robotic insertion, as well as image-guided surgery.


Assuntos
Implante Coclear , Implantes Cocleares , Humanos , Cóclea/cirurgia , Osso Temporal/cirurgia , Fenômenos Mecânicos
9.
Clin Case Rep ; 10(12): e6694, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36583197

RESUMO

We present the case of a 65 years old patient who developed a complete, sensorineural hearing loss on the right side due to an intravestibular schwannoma. Our video shows a transcanal, endoscopic approach with complete schwannoma removal on the right side, subsequent e-BERA recordings, and cochlear implantation.

10.
J Vis Exp ; (184)2022 06 16.
Artigo em Inglês | MEDLINE | ID: mdl-35786698

RESUMO

Robot-assisted systems offer great potential for gentler and more precise cochlear implantation. In this article, we provide a comprehensive overview of the clinical workflow for robotic cochlear implantation using a robotic system specifically developed for a minimally invasive, direct cochlear access. The clinical workflow involves experts from various disciplines and requires training to ensure a smooth and safe procedure. The protocol briefly summarizes the history of robotic cochlear implantation. The clinical sequence is explained in detail, beginning with the assessment of patient eligibility and covering surgical preparation, preoperative planning with the special planning software, drilling of the middle ear access, intraoperative imaging to confirm the trajectory, milling of the inner ear access, insertion of the electrode array, and implant management. The steps that require special attention are discussed. As an example, the postoperative outcome of robotic cochlear implantation in a patient with advanced otosclerosis is presented. Finally, the procedure is discussed in the context of the authors' experience.


Assuntos
Implante Coclear , Orelha Interna , Procedimentos Cirúrgicos Robóticos , Robótica , Cóclea/cirurgia , Implante Coclear/métodos , Orelha Interna/cirurgia , Humanos
11.
Front Neurol ; 13: 886171, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35832176

RESUMO

Introduction and Objectives: Among cochlear implant candidates, an increasing number of patients are presenting with residual acoustic hearing. To monitor the postoperative course of structural and functional preservation of the cochlea, a reliable objective biomarker would be desirable. Recently, impedance telemetry has gained increasing attention in this field. The aim of this study was to investigate the postoperative course of the residual acoustic hearing and clinical impedance in patients with long electrode arrays and to explore the applicability of impedance telemetry for monitoring residual hearing. Methods: We retrospectively analyzed records of 42 cochlear implant recipients with residual hearing covering a median postoperative follow-up of 25 months with repeated simultaneous pure tone audiometry and impedance telemetry. We used a linear mixed-effects model to estimate the relation between clinical electrode impedance and residual hearing. Besides the clinical impedance, the follow-up time, side of implantation, gender, and age at implantation were included as fixed effects. An interaction term between impedance and follow-up time, as well as subject-level random intercepts and slopes, were included. Results: Loss of residual hearing occurred either during surgery or within the first 6 post-operative months. Electrode contacts inserted further apically (i.e., deeper) had higher impedances, independent of residual hearing. The highest impedances were measured 1 month postoperatively and gradually decreased over time. Basal electrodes were more likely to maintain higher impedance. Follow-up time was significantly associated with residual hearing. Regardless of the time, we found that a 1 kΩ increase in clinical impedance was associated with a 4.4 dB deterioration of residual hearing (p < 0.001). Conclusion: Pure tone audiometry is the current gold standard for monitoring postoperative residual hearing. However, the association of clinical impedances with residual hearing thresholds found in our study could potentially be exploited for objective monitoring using impedance telemetry. Further analysis including near-field related impedance components could be performed for improved specificity to local immune responses.

12.
Int J Pediatr Otorhinolaryngol ; 159: 111204, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-35696773

RESUMO

INTRODUCTION: The preoperative determination of suitable electrode array lengths for cochlear implantation in inner ear malformations is a matter of debate. The choice is usually based on individual experience and the use of intraoperative probe electrodes. The purpose of this case series was to evaluate the applicability and precision of an angular insertion depth (AID) prediction method, based on a single measurement of the cochlear base length (CBL). METHODS: We retrospectively measured the CBL in preoperative computed tomography (CT) images in 10 ears (8 patients) with incomplete partition type 2 malformation. With the known electrode length (linear insertion depth, LID) the AID at full insertion was retrospectively predicted for each ear with a heuristic equation derived from non-malformed cochleae. Using the intra- or post-implantation cone beam CT images, the actual AID was assessed and compared. The deviations of the predicted from the actual insertion angles were quantified (clinical prediction error) to assess the precision of this single-measure estimation. RESULTS: Electrode arrays with 15 mm (n = 3), 19 mm (n = 2), 24 mm (n = 3), and 26 mm (n = 2) length were implanted. Postoperative AIDs ranged from 211° to 625°. Clinical AID prediction errors from -64° to 62° were observed with a mean of 0° (SD of 44°). In two ears with partial insertion of the electrode, the predicted AID was overestimated. The probe electrode was intraoperatively used in 9/10 cases. CONCLUSION: The analyzed method provides good predictions of the AID based on LID and CBL. It does not account for incomplete insertions, which lead to an overestimation of the AID. The probe electrode is useful and well established in clinical practice. The investigated method could be used for patient-specific electrode length selection in future patients.


Assuntos
Implante Coclear , Implantes Cocleares , Cóclea/diagnóstico por imagem , Cóclea/cirurgia , Implante Coclear/métodos , Eletrodos Implantados , Humanos , Estudos Retrospectivos , Tomografia Computadorizada por Raios X/métodos
13.
J Vis Exp ; (180)2022 02 16.
Artigo em Inglês | MEDLINE | ID: mdl-35253796

RESUMO

The microscopic transcanal (aka transmeatal) surgical approach was first described in the 60s, offering a minimally invasive means of reaching the external auditory canal, the middle ear, and epitympanon. Such an approach avoids a retroauricular or endaural skin incision; however, working through a narrow space needs angled microsurgical instruments and specific training in otologic surgery. The transcanal approach restricts the working space; however, it offers a binocular microscopic vision into the middle ear without extended skin incisions and thus, reducing post-operative pain and bleeding. In addition, this minimally invasive approach avoids scar tissue complications, hypoesthesia of the auricle, and potential protrusion of the pinna. Despite its numerous advantages, this method is still not routinely performed by otologic surgeons. Since this minimally invasive technique is more challenging, there is a need for extensive training in order for it to be widely adopted by otologic surgeons. This article provides step-by-step surgical instructions for stapes surgery and reports possible indications, pitfalls, and limitations using this microscopic transcanal technique.


Assuntos
Procedimentos Cirúrgicos Otológicos , Cirurgia do Estribo , Orelha Média/cirurgia , Endoscopia/métodos , Microcirurgia , Procedimentos Cirúrgicos Otológicos/métodos
14.
J Vis Exp ; (181)2022 03 08.
Artigo em Inglês | MEDLINE | ID: mdl-35343956

RESUMO

Electrocochleography (ECochG) measures inner ear potentials generated in response to acoustic stimulation of the ear. These potentials reflect the residual function of the cochlea. In cochlear implant candidates with residual hearing, the implant electrode can directly measure ECochG responses during the implantation process. Various authors have described the ability to monitor the inner ear function by continuous ECochG measurements during the surgery. The measurement of ECochG signals during surgery is not trivial. There are no interpretable signals in up to 20% of cases. For a successful recording, a standardized procedure is recommended to achieve the highest measurement reliability and avoid possible pitfalls. Therefore, seamless collaboration between the CI surgeon and CI technician is key. This video consists of an overview of the system setup and a stepwise procedure of performing intracochlear ECochG measurements during CI surgery. It shows the surgeon's and the CI technician's roles in the process, and how a smooth collaboration between the two is made possible.


Assuntos
Implante Coclear , Implantes Cocleares , Audiometria de Resposta Evocada/métodos , Cóclea/cirurgia , Implante Coclear/métodos , Reprodutibilidade dos Testes
15.
J Vis Exp ; (179)2022 01 19.
Artigo em Inglês | MEDLINE | ID: mdl-35129171

RESUMO

Implementation of endoscopes in cholesteatoma surgery resulted in considerable changes in the management of cholesteatoma in the last two decades. Compared to the microscopic approach with an excellent but straight-line view and limited illumination, the introduction of endoscopes provides a wide-angled panoramic view. Moreover, angled lenses allow the surgeon to visualize the middle ear and its hidden recesses through a transcanal, minimally-invasive approach. The endoscope enables the surgeon to remove limited cholesteatoma of the middle ear and its recesses using an exclusive endoscopic technique by taking advantage of these benefits. This reduces the rate of residual disease and sparing external incisions and excessive temporal bone drilling as in a transmastoid approach. Since transcanal endoscopic access is mainly a one-handed technique, it implies the need for specific procedures and technical refinements. This article describes a step-by-step guide as a surgical manual for endoscopic removal of epitympanic cholesteatoma. Different techniques for cholesteatoma dissection and bone removal for epitympanectomy, including curettage and powered instruments such as drills and ultrasonic devices with their outcomes, are discussed. This may offer ear surgeons insight into technical refinements and the latest technological developments and open the horizon for different techniques.


Assuntos
Colesteatoma da Orelha Média , Procedimentos Cirúrgicos Otológicos , Colesteatoma da Orelha Média/cirurgia , Orelha Média/cirurgia , Endoscopia/métodos , Humanos , Neoplasia Residual , Procedimentos Cirúrgicos Otológicos/métodos , Resultado do Tratamento
16.
Eur Arch Otorhinolaryngol ; 279(2): 645-652, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33616750

RESUMO

PURPOSE: In unilateral cochlear implant (CI) recipients, a contralateral routing of signals (CROS) device enables to receive auditory information from the unaided side. This study investigates the feasibility as well as subjective and objective benefits of using a CI processor as a CROS device in unilateral CI recipients. METHODS: This is a single-center, prospective cohort study. First, we tested the directionality of the CROS processor in an acoustic chamber. Second, we examined the difference of speech perception in quiet and in noise in ten unilateral CI recipients with and without the CROS processor. Third, subjective ratings with the CROS processor were evaluated according to the Client Oriented Scale of Improvement Questionnaire. RESULTS: There was a time delay between the two devices of 3 ms. Connection of the CROS processor led to a summation effect of 3 dB as well as a more constant amplification along all azimuths. Speech perception in quiet showed an increased word recognition score at 50 dB (mean improvement 7%). In noise, the head shadow effect could be mitigated with significant gain in speech perception (mean improvement 8.4 dB). This advantage was reversed in unfavorable listening situations, where the CROS device considerably amplified the noise (mean: - 4.8 dB). Subjectively, patients who did not normally wear a hearing aid on the non-CI side were satisfied with the CROS device. CONCLUSIONS: The connection and synchronization of a CI processor as a CROS device is technically feasible and the signal processing strategies of the device can be exploited. In contra-laterally unaided patients, a subjective benefit can be achieved when wearing the CROS processor.


Assuntos
Implante Coclear , Implantes Cocleares , Auxiliares de Audição , Percepção da Fala , Humanos , Estudos Prospectivos
17.
Front Surg ; 8: 742112, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34692764

RESUMO

Hypothesis: The use of freehand stereotactic image-guidance with a target registration error (TRE) of µTRE + 3σTRE < 0.5 mm for navigating surgical instruments during neurotologic surgery is safe and useful. Background: Neurotologic microsurgery requires work at the limits of human visual and tactile capabilities. Anatomy localization comes at the expense of invasiveness caused by exposing structures and using them as orientation landmarks. In the absence of more-precise and less-invasive anatomy localization alternatives, surgery poses considerable risks of iatrogenic injury and sub-optimal treatment. There exists an unmet clinical need for an accurate, precise, and minimally-invasive means for anatomy localization and instrument navigation during neurotologic surgery. Freehand stereotactic image-guidance constitutes a solution to this. While the technology is routinely used in medical fields such as neurosurgery and rhinology, to date, it is not used for neurotologic surgery due to insufficient accuracy of clinically available systems. Materials and Methods: A freehand stereotactic image-guidance system tailored to the needs of neurotologic surgery-most importantly sub-half-millimeter accuracy-was developed. Its TRE was assessed preclinically using a task-specific phantom. A pilot clinical trial targeting N = 20 study participants was conducted (ClinicalTrials.gov ID: NCT03852329) to validate the accuracy and usefulness of the developed system. Clinically, objective assessment of the TRE is impossible because establishing a sufficiently accurate ground-truth is impossible. A method was used to validate accuracy and usefulness based on intersubjectivity assessment of surgeon ratings of corresponding image-pairs from the microscope/endoscope and the image-guidance system. Results: During the preclinical accuracy assessment the TRE was measured as 0.120 ± 0.05 mm (max: 0.27 mm, µTRE + 3σTRE = 0.27 mm, N = 310). Due to the COVID-19 pandemic, the study was terminated early after N = 3 participants. During an endoscopic cholesteatoma removal, a microscopic facial nerve schwannoma removal, and a microscopic revision cochlear implantation, N = 75 accuracy and usefulness ratings were collected from five surgeons each grading 15 image-pairs. On a scale from 1 (worst rating) to 5 (best rating), the median (interquartile range) accuracy and usefulness ratings were assessed as 5 (4-5) and 4 (4-5) respectively. Conclusion: Navigating surgery in the tympanomastoid compartment and potentially in the lateral skull base with sufficiently accurate freehand stereotactic image-guidance (µTRE + 3σTRE < 0.5 mm) is feasible, safe, and useful. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03852329.

18.
Otol Neurotol ; 42(8): e1030-e1036, 2021 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-33859138

RESUMO

OBJECTIVES: Real-time electrocochleography (rt-ECochG) is a method to detect intracochlear potential changes during cochlear implantation (CI). Steep amplitude drops of the cochlear microphonic (CM) signal (so called "ECochG events") have been correlated with worse residual hearing outcomes. However, the sensitivity and specificity of monitoring CM amplitude on its own are too low to use it as a biomarker. The aim of this article was to establish if additional signal components would help to better predict postoperative hearing outcomes. DESIGN AND SETTING: Single-center, prospective cohort study at a tertiary referral hospital. PARTICIPANTS AND INTERVENTIONS: Between 2017 and 2020, we included 73 adult patients receiving a lateral wall cochlear implant electrode. During electrode insertion, rt-ECochG measurements were performed. MAIN OUTCOMES: We calculated a multiple regression analysis for patients with one ECochG event. The dependant variable was the relative acoustic hearing result 4 weeks after surgery. Independent variables were CM latency, a ratio of the auditory nerve neurophonic to the CM (the ANN/CM index) as well as CM signal recovery. RESULTS: The change of the ANN/CM index linearly correlated with acoustic hearing outcomes 4 weeks after surgery. Adding this factor led to a statistically significant increase in the variance accounted for by the regression model. CONCLUSIONS: When monitoring the implantation process with rt-ECochG, prediction of postoperative hearing thresholds is improved by addition of the ANN/CM index to a model that includes CM amplitude fluctuation.


Assuntos
Implante Coclear , Implantes Cocleares , Adulto , Audiometria de Resposta Evocada , Audição , Humanos , Estudos Prospectivos
19.
Ear Hear ; 41(6): 1560-1567, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33136631

RESUMO

OBJECTIVES: Real-time electrocochleography (ECochG) has been used as a monitoring tool during cochlear implantation (CI), whereby, amplitude drops have been correlated with postoperative acoustic hearing results. However, no consensus has been reached as to how a single event of an amplitude drop should be characterized. The aim of this study was to identify ECochG events that predict loss of hearing 1 month after surgery. DESIGN: Fifty-five patients were included in this prospective cohort study. Real-time ECochG measurements were performed during CI electrode insertion. Single ECochG events were characterized according to their amplitude loss and slope steepness. RESULTS: Using receiver operating characteristic analyses, the most efficient cut-off criterion for a relative hearing loss of 25% was an amplitude loss of 61% at a fixed slope steepness of 0.2 µV/sec. Three-quarters of our population had at least one such event during implantation. Most events occurred shortly before full insertion. With increasing number of events, median residual hearing thresholds deteriorated for all frequencies. Larger amplitude drops trended toward worse hearing preservation. Signal recovery after an ECochG event could not be correlated to acoustic hearing outcomes. CONCLUSIONS: Our data suggest that amplitude drops exceeding 61% of the ongoing signal at a slope steepness of 0.2 µV/sec are correlated with worse acoustic hearing preservation. Clearly defined ECochG events have the potential to guide surgeons during CI in the future. This is essential if a fully automated data analysis is to be employed or benchmarking undertaken.


Assuntos
Implante Coclear , Implantes Cocleares , Audiometria de Resposta Evocada , Cóclea/cirurgia , Humanos , Estudos Prospectivos
20.
Clin Otolaryngol ; 44(3): 254-262, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30588758

RESUMO

OBJECTIVES: To translate and validate the Zurich Chronic Middle Ear Inventory (ZCMEI-21) for the English language in order to provide an English instrument to assess health-related quality of life in chronic otitis media (COM). DESIGN: Pilot translation study including cognitive debriefings, prospective multicentre cross-sectional psychometric validation study. SETTING: Four tertiary referral centres in three different English-speaking countries (UK, USA and Australia). PARTICIPANTS: Adult patients suffering from COM. MAIN OUTCOME MEASURES: The English translation of the ZCMEI-21 (ZCMEI-21-E) and the five-level version of the EQ-5D questionnaire. The EQ-5D, which constitutes a generic measure of health-related quality of life, consists of a descriptive system score and a visual analogue scale. Statistical outcomes included single-item descriptive statistics, internal consistency (Cronbach's α) as an indicator of reliability, as well as construct validity. RESULTS: A total of 124 patients suffering from COM were included. The mean age was 50.1 years (SD 16.9 years), and 72 (58.1%) were males. The Cronbach's α of the ZCMEI-21-E was 0.91, suggesting an excellent internal consistency. The Spearman's correlation coefficient of the ZCMEI-21-E total score was 0.55 (P < 0.0001) for convergent construct validity with EQ-5D descriptive system score and 0.57 (P < 0.0001) with the EQ-5D visual analogue scale. CONCLUSIONS: The ZCMEI-21-E is a new validated questionnaire that provides clinicians with a short, comprehensive and reliable instrument to quantify health-related quality of life in patients suffering from COM. The ZCMEI-21-E may be of use in clinical routine as well as in outcome research and monitoring.


Assuntos
Idioma , Otite Média/psicologia , Psicometria/métodos , Qualidade de Vida , Traduções , Doença Crônica , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Reprodutibilidade dos Testes , Inquéritos e Questionários
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