Clinical Applicability of a Preoperative Angular Insertion Depth Prediction Method for Cochlear Implantation.

OBJECTIVE: Evaluation of the accuracy and clinical applicability of a single measure cochlear implant angular insertion depth prediction method. BACKGROUND: Cochlear implantation outcomes still vary extensively between patients. One of the possible reasons could be variability in intracochlear electrode array placement. For this reason, single measure methods were suggested to preoperatively predict angular insertion depths. Based on a previously performed accuracy study in human temporal bones, we were interested in determining the extent to which the method could be applied in a clinical setting. METHODS: A retrospective analysis was performed on pre- and postoperative radiographic images of 50 cochlear implant recipients. Preoperatively predicted angular insertion depths were compared with angular insertion depths measured on postoperative ground truth. The theoretical prediction error was computed under the assumption that all achieved insertions were matching the preoperatively assumed linear insertion depth. More importantly, the clinical prediction error was assessed using two different software tools performed by three experienced surgeons. RESULTS: Using the proposed method we found a theoretical prediction error of 5 degrees (SD = 41 degrees). The clinical prediction error including the cases with extracochlear electrodes was 70 degrees (SD = 96 degrees). CONCLUSIONS: The presented angular insertion depth prediction method is a first practical approach to support the preoperative selection of cochlear implant electrode arrays. However, the presented procedure is limited in that it is unable to predict the occurrence of insertion results with extracochlear electrodes and requires user training.

Robotic middle ear access for cochlear implantation: First in man.

To demonstrate the feasibility of robotic middle ear access in a clinical setting, nine adult patients with severe-to-profound hearing loss indicated for cochlear implantation were included in this clinical trial. A keyhole access tunnel to the tympanic cavity and targeting the round window was planned based on preoperatively acquired computed tomography image data and robotically drilled to the level of the facial recess. Intraoperative imaging was performed to confirm sufficient distance of the drilling trajectory to relevant anatomy. Robotic drilling continued toward the round window. The cochlear access was manually created by the surgeon. Electrode arrays were inserted through the keyhole tunnel under microscopic supervision via a tympanomeatal flap. All patients were successfully implanted with a cochlear implant. In 9 of 9 patients the robotic drilling was planned and performed to the level of the facial recess. In 3 patients, the procedure was reverted to a conventional approach for safety reasons. No change in facial nerve function compared to baseline measurements was observed. Robotic keyhole access for cochlear implantation is feasible. Further improvements to workflow complexity, duration of surgery, and usability including safety assessments are required to enable wider adoption of the procedure.

Robotic cochlear implantation: feasibility of a multiport approach in an ex vivo model.

PURPOSE: A recent clinical trial has shown the feasibility of robotic cochlear implantation. The electrode was inserted through the robotically drilled tunnel and an additional access through the external auditory canal was created to provide for means of visualization and manipulation. To obviate the need for this additional access, the utilization of multiple robotically drilled tunnels targeting the round window has been proposed. The objective of this study was to assess the feasibility of electrode insertion through a robotic multiport approach. METHODS: In four ex vivo human head specimens (left side), four trajectories through the facial recess (2x) and the retrofacial and suprameatal region were planned and robotically drilled. Optimal three-port configurations were determined for each specimen by analyzing combinations of three of the four trajectories, where the three trajectories were used for the electrode, endoscopic visualization and manipulative assistance. Finally, electrode insertions were conducted through the optimal configurations. RESULTS: The electrodes could successfully be inserted, and the procedure sufficiently visualized through the facial recess drill tunnels in all specimens. Effective manipulative assistance for sealing the round window could be provided through the retrofacial tunnel. CONCLUSIONS: Electrode insertion through a robotic three-port approach is feasible. Drill tunnels through the facial recess for the electrode and endoscope allow for optimized insertion angles and sufficient visualization. Through a retrofacial tunnel effective manipulation for sealing is possible.

Neuromonitoring During Robotic Cochlear Implantation: Initial Clinical Experience.

During robotic cochlear implantation a drill trajectory often passes at submillimeter distances from the facial nerve due to close lying critical anatomy of the temporal bone. Additional intraoperative safety mechanisms are thus required to ensure preservation of this vital structure in case of unexpected navigation system error. Electromyography based nerve monitoring is widely used to aid surgeons in localizing vital nerve structures at risk of injury during surgery. However, state of the art neuromonitoring systems, are unable to discriminate facial nerve proximity within submillimeter ranges. Previous work demonstrated the feasibility of utilizing combinations of monopolar and bipolar stimulation threshold measurements to discretize facial nerve proximity with greater sensitivity and specificity, enabling discrimination between safe (> 0.4 mm) and unsafe (< 0.1 mm) trajectories during robotic cochlear implantation (in vivo animal model). Herein, initial clinical validation of the determined stimulation protocol and nerve proximity analysis integrated into an image guided system for safety measurement is presented. Stimulation thresholds and corresponding nerve proximity values previously determined from an animal model have been validated in a first-in-man clinical trial of robotic cochlear implantation. Measurements performed automatically at preoperatively defined distances from the facial nerve were used to determine safety of the drill trajectory intraoperatively. The presented system and automated analysis correctly determined sufficient safety distance margins (> 0.4 mm) to the facial nerve in all cases.

Accuracy and feasibility of a dedicated image guidance solution for endoscopic lateral skull base surgery.

OBJECTIVE: We aimed to design, build and validate a surgical navigation system which fulfills the accuracy requirements for surgical procedures on the ear and the lateral skull base, and which integrates with the endoscopic workflow and operating room setup. MATERIALS AND METHODS: The navigation system consists of portable tablet computer (iPad Pro, Apple Computer, USA) and an optical tracking system (Cambar B1, Axios3D, Germany), both connected via a wireless Bluetooth link and attached directly to the OR table. Active optical tracking references are rigidly fixed to both the patient and surgical tools. Software to support image import, registration and 2D/3D visualization has been developed. Two models were used for targeting accuracy assessment: a technical phantom model and an ex vivo temporal bone model. Additionally, workflow integration and usability of the navigation system during endoscopic lateral skull base procedures was investigated in ex vivo experiments on 12 sides of cadaver head specimens. RESULTS: The accuracy experiments revealed a target registration error in the technical phantom model of 0.20 ± 0.10 mm (n = 36) and during the ex vivo assessment of 0.28 ± 0.10 mm (n = 21). Navigation was successfully carried out in n = 36 procedures (infracochlear, suprageniculate and transpromontorial approach), with navigated instruments usable without interference with the endoscope. The system aided in the successful and accurate identification of vital anatomical structures. CONCLUSIONS: Useful surgical navigation is, to a large extent, a result of sufficiently accurate tracking technology. We have demonstrated sufficient accuracy and a potentially suitable integration for surgical application within endoscopic lateral skull base procedures.

Robotic cochlear implantation: surgical procedure and first clinical experience.

CONCLUSION: A system for robotic cochlear implantation (rCI) has been developed and a corresponding surgical workflow has been described. The clinical feasibility was demonstrated through the conduction of a safe and effective rCI procedure. OBJECTIVES: To define a clinical workflow for rCI and demonstrate its feasibility, safety, and effectiveness within a clinical setting. METHOD: A clinical workflow for use of a previously described image guided surgical robot system for rCI was developed. Based on pre-operative images, a safe drilling tunnel targeting the round window was planned and drilled by the robotic system. Intra-operatively the drill path was assessed using imaging and sensor-based data to confirm the proximity of the facial nerve. Electrode array insertion was manually achieved under microscope visualization. Electrode array placement, structure preservation, and the accuracy of the drilling and of the safety mechanisms were assessed on post-operative CT images. RESULTS: Robotic drilling was conducted with an accuracy of 0.2 mm and safety mechanisms predicted proximity of the nerves to within 0.1 mm. The approach resulted in a minimal mastoidectomy and minimal incisions. Manual electrode array insertion was successfully performed through the robotically drilled tunnel. The procedure was performed without complications, and all surrounding structures were preserved.