Electrode impedance changes after implantation of a dexamethasone-eluting intracochlear array.

Postoperative inflammation and the formation of fibrotic tissue around the intracochlear electrode array are often held responsible for negative outcomes in cochlear implant recipients. Here we test the effectiveness of intracochlear delivery of dexamethasone via a drug-eluting electrode array in reducing fibrotic tissue formation, assessed via measurement of both monopolar and four-point electrode impedance. Adult guinea pigs were bilaterally implanted with a dexamethasone-eluting array (left ear) and a standard non-eluting array (right ear). Arrays were electrically stimulated daily for 4 weeks, commencing 1 week after implantation, and impedance measured both before and after stimulation. Histological assessment of the tissue was made at the end of the 5-week period. The dexamethasone-eluting array did not reduce monopolar (MP1 + 2) electrode impedance over the course of 5 weeks, and no significant difference was observed in fibrotic tissue, new bone growth, or spiral ganglion neuron density between array types. However, four-point impedance, which provides an indication of the local environment at the neural-tissue interface, was significantly lower in the presence of dexamethasone. A strong relationship was seen between four-point and monopolar impedance for individual electrode arrays, with the exception of the standard array after daily electrical stimulation. This group instead showed a significant correlation between the final four-point impedance measure and percentage of fibrous tissue and new bone growth. In conclusion, this study demonstrated that dexamethasone influences four-point electrode impedance as well as the relationship between fibrotic tissue and impedance, and that both outcomes are shaped by daily electrical stimulation. These results suggest a change occurs at the local tissue-electrode interface in the presence of sustained, intracochlear release of dexamethasone.

Evaluation of Intracochlear Position of a Slim Modiolar Electrode Array, by Using Different Radiological Analyses.

INTRODUCTION: The radiological analysis following a cochlear implantation offers insight into the audiological outcomes of cochlear implant recipients. The wrapping factor (WF) is the most common radiological analysis measuring the modiolar position and depth of insertion of an electrode array. New measurements like the intracochlear position index (ICPI) or the homogeneity factor (HF) can offer more accurate information regarding the electrode's intracochlear position. We have also studied a new method to calculate the WF, by normalizing it with a new methodology (WFn). OBJECTIVES: To analyze and compare the results of the WF, ICPI, HF, and WFn obtained using a cone beam computer tomography (CBCT) with the histological analysis on temporal bone. MATERIAL: A perimodiolar electrode array (Nucleus Slim CI532) was inserted in three temporal bones. A perfect insertion was performed in the first temporal bone, according to the correct specifications. In the second specimen, a slightly over-inserted electrode was analyzed and in the third specimen a completely over-inserted electrode array was studied. METHOD: A CBCT was performed following the implantations and then, a histological analysis with slices perpendicular to the cochlea axis (modiolus). Each measurement was made 10 times by 10 experts (radiologist and otologist) with a total amount of 600 measurements (100 for each data, 3 CBCT and 3 histology). A t test statistical analysis was performed to compare the measurements between CBCT and histology. RESULTS: It was observed that the ICPI and the HF correctly identify the three different insertions. Regarding the WF no significant difference in the two over-inserted specimens was found. The ICPI was the only measurement that shows no statistical difference between the CBCT and the histology, so it was considered the most accurate method. Finally, the WF shows a statistical difference between the CBCT and the histology in all cases, indicating the poor value of the radiological method. The WFn analysis includes the modiolar wall length in the measurement. This improves the final result as it reduces the error induced by the size of the cochlea. CONCLUSION: The ICPI and the HF provide better radiological information than the WF, regarding the intracochlear position of the electrode array. The most relevant difference is that the ICPI, HF, and WFn include modiolar and lateral wall dimensions, thereby using the diameter of the cochlear duct for the analysis.

Techniques for processing eyes implanted with a retinal prosthesis for localized histopathological analysis: Part 2 Epiretinal implants with retinal tacks.

Retinal prostheses for the treatment of certain forms of blindness are gaining traction in clinical trials around the world with commercial devices currently entering the market. In order to evaluate the safety of these devices, in preclinical studies, reliable techniques are needed. However, the hard metal components utilised in some retinal implants are not compatible with traditional histological processes, particularly in consideration for the delicate nature of the surrounding tissue. Here we describe techniques for assessing the health of the eye directly adjacent to a retinal implant secured epiretinally with a metal tack. Retinal prostheses feature electrode arrays in contact with eye tissue. The most commonly used location for implantation is the epiretinal location (posterior chamber of the eye), where the implant is secured to the retina with a metal tack that penetrates all the layers of the eye. Previous methods have not been able to assess the proximal ocular tissue with the tack in situ, due to the inability of traditional histological techniques to cut metal objects. Consequently, it has been difficult to assess localized damage, if present, caused by tack insertion. Therefore, we developed a technique for visualizing the tissue around a retinal tack and implant. We have modified an established technique, used for processing and visualizing hard bony tissue around a cochlear implant, for the soft delicate tissues of the eye. We orientated and embedded the fixed eye tissue, including the implant and retinal tack, in epoxy resin, to stabilise and protect the structure of the sample. Embedded samples were then ground, polished, stained, and imaged under various magnifications at incremental depths through the sample. This technique allowed the reliable assessment of eye tissue integrity and cytoarchitecture adjacent to the metal tack.

Reliability of cone beam computed tomography in scalar localization of the electrode array: a radio histological study.

Postoperative imaging plays a growing role in clinical studies concerning prognostic factors in cochlear implantation. Indeed, intracochlear position of the cochlear implant has recently been identified as a contributor in functional outcomes and radiological tools must be accurate enough to determine the final placement of the electrode array. The aim of our study was to validate cone beam computed tomography as a reliable technique for scalar localization of the electrode array. We performed therefore a temporal bone study on ten specimens that were implanted with a perimodiolar implant prototype. Cone beam reconstructions were performed and images were analyzed by two physicians both experienced in cochlear implant imaging, who determined the scalar localization of the implant. Temporal bones then underwent histological control to document this scalar localization and hypothetical intracochlear lesions. In four cases, a dislocation from scala tympani to scala vestibuli was suspected on cone beam reconstructions of the ascending part of the basal turn. In three of these four specimens, dislocation in pars ascendens was confirmed histologically. In the remaining temporal bone, histological analysis revealed an elevation with rupture of the basilar membrane. Histological assessment revealed spiral ligament tearing in another bone. We conclude that cone beam is a reliable tool to assess scalar localization of the selectrode array and may be used in future clinical studies.