Trauma After Cochlear Implantation: The Accuracy of Micro-Computed Tomography and Cone-Beam Fusion Computed Tomography Compared With Histology in Human Temporal Bones.

HYPOTHESIS: Micro-computed tomography (micro-CT) and cone-beam computed tomography (CBCT), in conjunction with the image fusion technique, may provide similar results for trauma assessment after cochlear implantation, with respect to the trauma evaluation in preclinical cochlear implant (CI) studies, as the histology. BACKGROUND: Before clinical use, novel cochlear implant (CI) designs are tested in temporal bone (TB) studies for usability and risk evaluation. The criterion standard for evaluating intracochlear insertion trauma and electrode location has historically been with histological samples. Progress of modern imaging technology has created alternatives to classic histology. This study compares the micro-CT and CBCT fusion images between histological samples in a preclinical CI study. METHODS: Fourteen freshly frozen TBs were inserted with a lateral wall research CI electrode. All TBs were scanned with CBCT preoperatively and postoperatively. After insertion, the TBs were prepared for micro-CT and histology. Twelve TBs underwent first a micro-CT and then the histological process. The CBCTs were used for image fusion, and all three different methods were used for intracochlear trauma evaluation. The results were compared between methods. RESULTS: There were 4 of 14 translocations detected with the fusion image method and 3 of 12 with the micro-CT and histology. When compared, the trauma grades converged and were not statistically significant. CONCLUSION: The trauma grading based on micro-CT is comparable to the histology. The image fusion technique based on CBCT is less accurate because it relies on an empirical assumption of the basal membrane localization, but it is clinically applicable.

A New Application of CBCT Image Fusion in Temporal Bone Studies.

OBJECTIVES: Temporal bone (TB) studies are essential during the development of new arrays. Postoperative cochlear histology is still regarded as golden standard for the assessment of electrode localization and trauma though it is time consuming, expensive and technically very demanding. The aim of this study is to investigate whether pre-operative evacuation of perilymph improve the assessment of electrode localization and insertion trauma in TBs applying fusion imaging. The results were compared to a prior validated image fusion technique based on the quantification of the electrode placement. MATERIALS AND METHODS: 12 prototype electrodes were implanted in fresh frozen TBs. The perilymph was evacuated from the scale prior to pre-operative cone-beam computer tomography (CBCT). The TB were then immersed in Ringer solution to rehydrated both scalae. After electrode insertion post-operative CBCT were obtained. 3D fusions of the pre- and postoperative registration were reconstructed. The electrode localization with respect to the basilar membrane was visually assessed. RESULTS: The visualization of the BM on the pre-operative scans was achieved beyond the second turn in all TBs. The visual assessment was found to be as accurate as the previously validated fusion technique. There was no statistically significant difference between the methods (p=0.564). The image reconstructions and evaluations, however, were faster to perform and the insertion results are immediately available. CONCLUSION: CBCT in combination with pre- and postoperative image fusion is an accurate method for the post-operative assessment of insertion trauma in TBs. This new application facilitates the identification of the BM and allows for a visual assessment of insertion trauma.

Cochlear Implantation With a Novel Long Straight Electrode: the Insertion Results Evaluated by Imaging and Histology in Human Temporal Bones.

HYPOTHESIS: To evaluate the insertion results of a novel straight array (EVO) by detailed imaging and subsequent histology in human temporal bones (TB). BACKGROUND: The main focuses of modern cochlear implant surgery are to prevent damage to the intracochlear structures and to preserve residual hearing. This is often achievable with new atraumatic electrode arrays in combination with meticulous surgical techniques. METHODS: Twenty fresh-frozen TBs were implanted with the EVO. Pre- and postoperative cone beam computed tomography scans were reconstructed and fused for an artifact-free representation of the electrode. The array's vertical position was quantified in relation to the basilar membrane on basis of which trauma was classified (Grades 0-4). The basilar membrane location was modeled from previous histologic data. The TBs underwent subsequent histologic examination. RESULTS: The EVOs were successfully inserted in all TBs. Atraumatic insertion (Grades 0-1) were accomplished in 14 of 20 TBs (70%). There were three apical translocations, and two basal translocations due to electrode bulging. One TB had multiple translocations. The sensitivity and specificity of imaging for detecting insertion trauma (Grades 2-4) was 87.5% and 97.3.0%, respectively. CONCLUSION: Comparable insertion results as reported for other arrays were also found for the EVO. Insertion trauma can be mostly avoided with meticulous insertion techniques to prevent bulging and by limiting the insertion depth angle to 360 degrees. The image fusion technique is a reliable tool for evaluating electrode placement and is feasible for trauma grading.

Evaluation of a new slim lateral wall electrode for cochlear implantation: an imaging study in human temporal bones.

PURPOSE: To evaluate the insertion characteristics and trauma of a new slim lateral wall electrode (SlimJ) in human temporal bones (TB). METHODS: Pre- and postoperative assessment was performed using cone beam computed tomography (CBCT) and image fusion in 11 human TB. The position of the array in each cochlea was analyzed and described using a vertical scaling factor, calculated by dividing the distance of the scala tympani floor to the centre of the electrode by the duct height. Insertion trauma was scaled according to the presumed localization of the basilar membrane, which was modeled from histologic sections of 20 TBs. The insertion trauma was described by the adaptation of the Eshragi trauma grading. RESULTS: A full electrode insertion, via the round window, was achieved in all TBs. Surgical handling was good, with a favorable compromise between high flexibility but sufficient stiffness to facilitate smooth insertions. The median angular insertion depth was 368° (range 330°-430°). Scala tympani placement was achieved in ten out of eleven TBs; in one TB a scala translocation was observed, occurring at approximately 180°. CONCLUSIONS: The SlimJ showed atraumatic insertion characteristics. The CBCT fusion technique provides an accurate and reliable assessment of the electrode position and allows for grading insertion trauma without histology. The SlimJ true potential for structure and hearing preservation needs to be further assessed in vivo.

A New Slim Modiolar Electrode Array for Cochlear Implantation: A Radiological and Histological Study.

HYPOTHESIS: To explore the results of a new slim modiolar electrode array (SMA) with respect to intracochlear placement and trauma evaluated by detailed radiologic imaging and histology. BACKGROUND: Hearing and structure preservation is the goal of cochlear implantation for advanced hearing outcomes. Currently, this is most consistently achieved with thin lateral wall electrodes. Modiolar electrodes are located nearer the modiolus and may provide some electrophysiological advantages, but have a greater tendency for causing insertion trauma. METHODS: The SMA was implanted in 20 fresh-frozen human temporal bones (TB). All TBs were scanned pre- and postoperatively with cone beam computed tomography. For atraumatic insertion, the round window approach was preferred. Scalar localization and trauma were analyzed by three-dimensional image fusion reconstructions of the pre- and postimplant scans. The TBs underwent histologic examination to validate the radiologic findings. RESULTS: Insertion through the round window was performed in 19 TBs and through a cochleostomy in one TB. In one TB trauma in the form of scala translocation was identified radiologically and histologically. In the remaining TBs there was no insertion trauma. Adequate modiolar localization of the SMA was found in 19 of 20 TBs. The mean angular insertion depth was 400 degrees without correlation to cochlea size. There was no significant statistical difference between the radiological and histological measurements of electrode localization. CONCLUSION: The SMA showed consistent and atraumatic insertion results in TBs. Pre- and postimplant cone beam computed tomography with image fusion was shown to be very accurate for the assessment of electrode position and insertion trauma.

Insertion characteristics and placement of the Mid-Scala electrode array in human temporal bones using detailed cone beam computed tomography.

The aim of this study was to evaluate the insertion results and placement of the new Advanced Bionics HiFocus Mid-Scala (HFms) electrode array, inserted through the round window membrane, in eight fresh human temporal bones using cone beam computed tomography (CBCT). Pre- and post-insertion CBCT scans were registered to create a 3D reconstruction of the cochlea with the array inserted. With an image fusion technique both the bony edges of the cochlea and the electrode array in situ could accurately be determined, thus enabling to identify the exact position of the electrode array within the scala tympani. Vertical and horizontal scalar location was measured at four points along the cochlea base at an angular insertion depth of 90°, 180° and 270° and at electrode 16, the most basal electrode. Smooth insertion through the round window membrane was possible in all temporal bones. The imaging results showed that there were no dislocations from the scala tympani into the scala vestibule. The HFms electrode was positioned in the middle of the scala along the whole electrode array in three out of the eight bones and in 62 % of the individual locations measured along the base of the cochlea. In only one cochlea a close proximity of the electrode with the basilar membrane was observed, indicating possible contact with the basilar membrane. The results and assessments presented in this study appear to be highly accurate. Although a further validation including histopathology is needed, the image fusion technique described in this study represents currently the most accurate method for intracochlear electrode assessment obtainable with CBCT.