Otosclerosis under microCT: New insights into the disease and its anatomy.

Purpose: Otospongiotic plaques can be seen on conventional computed tomography (CT) as focal lesions around the cochlea. However, the resolution remains insufficient to enable evaluation of intracochlear damage. MicroCT technology provides resolution at the single micron level, offering an exceptional amplified view of the otosclerotic cochlea. In this study, a non-decalcified otosclerotic cochlea was analyzed and reconstructed in three dimensions for the first time, using microCT technology. The pre-clinical relevance of this study is the demonstration of extensive pro-inflammatory buildup inside the cochlea which cannot be seen with conventional cone-beam CT (CBCT) investigation. Materials and Methods: A radiological and a three-dimensional (3D) anatomical study of an otosclerotic cochlea using microCT technology is presented here for the first time. 3D-segmentation of the human cochlea was performed, providing an unprecedented view of the diseased area without the need for decalcification, sectioning, or staining. Results: Using microCT at single micron resolution and geometric reconstructions, it was possible to visualize the disease's effects. These included intensive tissue remodeling and highly vascularized areas with dilated capillaries around the spongiotic foci seen on the pericochlear bone. The cochlea's architecture as a morphological correlate of the otosclerosis was also seen. With a sagittal cut of the 3D mesh, it was possible to visualize intense ossification of the cochlear apex, as well as the internal auditory canal, the modiolus, the spiral ligament, and a large cochleolith over the osseous spiral lamina. In addition, the oval and round windows showed intense fibrotic tissue formation and spongiotic bone with increased vascularization. Given the recently described importance of the osseous spiral lamina in hearing mechanics and that, clinically, one of the signs of otosclerosis is the Carhart notch observed on the audiogram, a tonotopic map using the osseous spiral lamina as region of interest is presented. An additional quantitative study of the porosity and width of the osseous spiral lamina is reported. Conclusion: In this study, structural anatomical alterations of the otosclerotic cochlea were visualized in 3D for the first time. MicroCT suggested that even though the disease may not appear to be advanced in standard clinical CT scans, intense tissue remodeling is already ongoing inside the cochlea. That knowledge will have a great impact on further treatment of patients presenting with sensorineural hearing loss.

Image-Based Planning of Minimally Traumatic Inner Ear Access for Robotic Cochlear Implantation.

Objective: During robotic cochlear implantation, an image-guided robotic system provides keyhole access to the scala tympani of the cochlea to allow insertion of the cochlear implant array. To standardize minimally traumatic robotic access to the cochlea, additional hard and soft constraints for inner ear access were proposed during trajectory planning. This extension of the planning strategy aims to provide a trajectory that preserves the anatomical and functional integrity of critical intra-cochlear structures during robotic execution and allows implantation with minimal insertion angles and risk of scala deviation. Methods: The OpenEar dataset consists of a library with eight three-dimensional models of the human temporal bone based on computed tomography and micro-slicing. Soft constraints for inner ear access planning were introduced that aim to minimize the angle of cochlear approach, minimize the risk of scala deviation and maximize the distance to critical intra-cochlear structures such as the osseous spiral lamina. For all cases, a solution space of Pareto-optimal trajectories to the round window was generated. The trajectories satisfy the hard constraints, specifically the anatomical safety margins, and optimize the aforementioned soft constraints. With user-defined priorities, a trajectory was parameterized and analyzed in a virtual surgical procedure. Results: In seven out of eight cases, a solution space was found with the trajectories safely passing through the facial recess. The solution space was Pareto-optimal with respect to the soft constraints of the inner ear access. In one case, the facial recess was too narrow to plan a trajectory that would pass the nerves at a sufficient distance with the intended drill diameter. With the soft constraints introduced, the optimal target region was determined to be in the antero-inferior region of the round window membrane. Conclusion: A trend could be identified that a position between the antero-inferior border and the center of the round window membrane appears to be a favorable target position for cochlear tunnel-based access through the facial recess. The planning concept presented and the results obtained therewith have implications for planning strategies for robotic surgical procedures to the inner ear that aim for minimally traumatic cochlear access and electrode array implantation.

Robotic Milling of Electrode Lead Channels During Cochlear Implantation in an ex-vivo Model.

Objective: Robotic cochlear implantation is an emerging surgical technique for patients with sensorineural hearing loss. Access to the middle and inner ear is provided through a small-diameter hole created by a robotic drilling process without a mastoidectomy. Using the same image-guided robotic system, we propose an electrode lead management technique using robotic milling that replaces the standard process of stowing excess electrode lead in the mastoidectomy cavity. Before accessing the middle ear, an electrode channel is milled robotically based on intraoperative planning. The goal is to further standardize cochlear implantation, minimize the risk of iatrogenic intracochlear damage, and to create optimal conditions for a long implant life through protection from external trauma and immobilization in a slight press fit to prevent mechanical fatigue and electrode migrations. Methods: The proposed workflow was executed on 12 ex-vivo temporal bones and evaluated for safety and efficacy. For safety, the difference between planned and resulting channels were measured postoperatively in micro-computed tomography, and the length outside the planned safety margin of 1.0 mm was determined. For efficacy, the channel width and depth were measured to assess the press fit immobilization and the protection from external trauma, respectively. Results: All 12 cases were completed with successful electrode fixations after cochlear insertions. The milled channels stayed within the planned safety margins and the probability of their violation was lower than one in 10,000 patients. Maximal deviations in lateral and depth directions of 0.35 and 0.29 mm were measured, respectively. The channels could be milled with a width that immobilized the electrode leads. The average channel depth was 2.20 mm, while the planned channel depth was 2.30 mm. The shallowest channel depth was 1.82 mm, still deep enough to contain the full 1.30 mm diameter of the electrode used for the experiments. Conclusion: This study proposes a robotic electrode lead management and fixation technique and verified its safety and efficacy in an ex-vivo study. The method of image-guided robotic bone removal presented here with average errors of 0.2 mm and maximal errors below 0.5 mm could be used for a variety of other otologic surgical procedures.

In Silico Assessment of Safety and Efficacy of Screw Placement for Pediatric Image-Guided Otologic Surgery.

Introduction: Current high-accuracy image-guided systems for otologic surgery use fiducial screws for patient-to-image registration. Thus far, these systems have only been used in adults, and the safety and efficacy of the fiducial screw placement has not yet been investigated in the pediatric population. Materials and Methods: In a retrospective study, CT image data of the temporal region from 11 subjects meeting inclusion criteria (8-48 months at the time of surgery) were selected, resulting in n = 20 sides. These datasets were investigated with respect to screw stability efficacy in terms of the cortical layer thickness, and safety in terms of the distance of potential fiducial screws to the dura mater or venous sinuses. All of these results are presented as distributions, thickness color maps, and with descriptive statistics. Seven regions within the temporal bone were analyzed individually. In addition, four fiducial screws per case with 4 mm thread-length were placed in an additively manufactured model according to the guidelines for robotic cochlear implantation surgery. For all these screws, the minimal distance to the dura mater or venous sinuses was measured, or if applicable how much they penetrated these structures. Results: The cortical layer has been found to be mostly between 0.7-3.3 mm thick (from the 5th to the 95th percentile), while even thinner areas exist. The distance from the surface of the temporal bone to the dura mater or the venous sinuses varied considerably between the subjects and ranged mostly from 1.1-9.3 mm (from the 5th to the 95th percentile). From all 80 placed fiducial screws of 4 mm thread length in the pediatric subject younger than two years old, 22 touched or penetrated either the dura or the sigmoid sinus. The best regions for fiducial placement would be the mastoid area and along the petrous pyramid in terms of safety. In terms of efficacy, the parietal followed by the petrous pyramid, and retrosigmoid regions are most suited. Conclusion: The current fiducial screws and the screw placement guidelines for adults are insufficiently safe or effective for pediatric patients.

Freehand Stereotactic Image-Guidance Tailored to Neurotologic Surgery.

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.