Cochlear Implant Receiver Location and Migration: Experimental Validation Pilot Study of a Clinically Applicable Screening Method

Markodimitraki, Laura M.; Stegeman, Inge; Smit, A.L.; Thomeer, Hans G. X. M.

doi:10.3389/fsurg.2019.00078

Cited by 3 publications

(2 citation statements)

References 25 publications

(35 reference statements)

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“…Although these methods provide an objective outcome measure, test–retest variability as well as inter-rater variability might be taken into account. In a recent publication by our group, a similar measurement method was tested and validated (34). According to our results, not all anatomical landmarks are applicable when assessing the position of the R/S device.…”

Section: Discussionmentioning

confidence: 86%

Cochlear Implant Fixation Techniques: A Systematic Review of the Literature

Markodimitraki

Strijbos²,

Stegeman

et al. 2021

Otology &Amp; Neurotology

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Objective: Given the lack of consensus on fixation techniques of the cochlear implant, this review aims to create an up-to-date overview of intra-and postoperative complications, focusing on migration of the internal receiver/stimulator (R/S) device and the electrode array. Data Sources: On June 29, 2020 we conducted a search in PubMed, Embase, Cochrane, Web of Science, and CINAHL. Keywords were ''Cochlear implant,'' ''complication,'' ''migration,'' and synonyms. Study Selection: Studies were considered if: 1) the adult study population consisted of ! 10 patients, 2) the R/S device was fixated using the bony well or tight subperiostal pocket technique without bone-anchoring sutures or screws on the implant, and 3) migration of the R/S device or displacement of the electrode array were described as outcomes. Data Extraction: Study characteristics, interventions, followup, and outcomes were extracted. For critical appraisal, an adapted version of the Newcastle-Ottawa quality assessment scale for cohort studies was used. Data Synthesis: Seven studies were included (n ¼ 430 patients). Migration of the R/S device was reported by three studies. Two studies applying the tight pocket technique reported migration rates ranging from 9.0 to 69.2%. One study using the bony bed technique reported migration of 100%, with an average of 2.5 mm. All studies lacked the required standard for comparability, assessment of outcome, and follow-up. Conclusions and Relevance: There is currently no evidence of a difference between the bony bed-and tight pocket fixation technique, regarding migration of the R/S device or the electrode array, in adult patients.

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Section: Discussionmentioning

confidence: 86%

Cochlear Implant Fixation Techniques: A Systematic Review of the Literature

Markodimitraki

Strijbos²,

Stegeman

et al. 2021

Otology &Amp; Neurotology

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“…Our results also show a high translational deviation in the Y-axis in these specimens, suggesting a tendency to place the implant more posteriorly. Finally, the translational analysis of the center of the magnet is an easy to interpret analysis of the accuracy which could also be applied in clinic using a flexible tape measure method, validated by our group [ 19 ]. Based on the results from this study the largest median deviation would be expected in the Z-axis.…”

Section: Discussionmentioning

confidence: 99%

Cochlear implant positioning and fixation using 3D-printed patient specific surgical guides; a cadaveric study

et al. 2022

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Hypothesis To develop and validate the optimal design and evaluate accuracy of individualized 3D- printed surgical guides for cochlear implantation. Background Positioning and fixation of the cochlear implant (CI) are commonly performed free hand. Applications of 3-dimensional (3D) technology now allow us to make patient specific, bone supported surgical guides, to aid CI surgeons with precise placement and drilling out the bony well which accommodates the receiver/stimulator device of the CI. Methods Cone beam CT (CBCT) scans were acquired from temporal bones in 9 cadaveric heads (18 ears), followed by virtual planning of the CI position. Surgical, bone-supported drilling guides were designed to conduct a minimally invasive procedure and were 3D-printed. Fixation screws were used to keep the guide in place in predetermined bone areas. Specimens were implanted with 3 different CI models. After implantation, CBCT scans of the implanted specimens were performed. Accuracy of CI placement was assessed by comparing the 3D models of the planned and implanted CI’s by calculating the translational and rotational deviations. Results Median translational deviations of placement in the X- and Y-axis were within the predetermined clinically relevant deviation range (< 3 mm per axis); median translational deviation in the Z-axis was 3.41 mm. Median rotational deviations of placement for X-, Y- and Z-rotation were 5.50°, 4.58° and 3.71°, respectively. Conclusion This study resulted in the first 3D-printed, patient- and CI- model specific surgical guide for positioning during cochlear implantation. The next step for the development and evaluation of this surgical guide will be to evaluate the method in clinical practice.

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A monocenter, patient-blinded, randomized, parallel-group, non-inferiority study to compare cochlear implant receiver/stimulator device fixation techniques (COMFIT) with and without drilling in adults eligible for primary cochlear implantation

Markodimitraki,

Harkel,

Bennink

et al. 2023

Trials

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Background During the cochlear implantation procedure, the receiver/stimulator (R/S) part of the implant is fixated to prevent postoperative device migration, which could have an adverse effect on the position of the electrode array in the cochlea. We aim to compare the migration rates of two fixation techniques, the bony recess versus the subperiosteal tight pocket without bony sutures. Methods and analysis This single-blind randomized controlled trial will recruit a total of 112 primary cochlear implantation adult patients, eligible for implantation according to the current standard of practice. Randomization will be performed by an electronic data capture system Castor EDC, with participants block randomized to either bony recess or standard subperiosteal tight pocket in a 1:1 ratio, stratified by age. The primary outcome of this study is the R/S device migration rate; secondary outcomes include patient-experienced burden using the validated COMPASS questionnaire, electrode migration rate, electrode impedance values, speech perception scores, correlation between R/S migration, electrode array migration and patient complaints, assessment of complication rates, and validation of an implant position measurement method. Data will be collected at baseline, 1 week, 4 weeks, 8 weeks, 3 months, and 12 months after surgery. All data analyses will be conducted according to the intention-to-treat principle. Discussion Cochlear implantation by means of creating a tight subperiosteal pocket without drilling a bony seat is a minimally invasive fixation technique with many advantages. However, the safety of this technique has not yet been proven with certainty. This is the first randomized controlled trial that directly compares the minimally invasive technique with the conventional method of drilling a bony seat. Trial registration Netherlands Trial Register NL9698. Registered on 31 August 2021.

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Cochlear Implant Receiver Location and Migration: Experimental Validation Pilot Study of a Clinically Applicable Screening Method

Abstract: Objectives: Postoperative follow-up after cochlear implantation lacks a reliable screening method to detect cochlear implant receiver device migration. This study aims to validate a clinically applicable method to assess the position and migration of the cochlear implant receiver device.

Cited by 3 publications

References 25 publications

Cochlear Implant Fixation Techniques: A Systematic Review of the Literature

Cochlear Implant Fixation Techniques: A Systematic Review of the Literature

Cochlear implant positioning and fixation using 3D-printed patient specific surgical guides; a cadaveric study

A monocenter, patient-blinded, randomized, parallel-group, non-inferiority study to compare cochlear implant receiver/stimulator device fixation techniques (COMFIT) with and without drilling in adults eligible for primary cochlear implantation

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