Dataset Information

Evaluating Reasons for Revision Surgery and Device Failure Rates in Patients Who Underwent Cochlear Implantation Surgery.

ABSTRACT:

Importance

Understanding the reasons for cochlear implant (CI) revision surgery and device failure rates is important for clinicians when counseling patients who are considering CI.

Objectives

To analyze the revision surgery rate, reasons for revision surgery, and device failure and survival rates of different device models in recipients of CIs.

Design, setting, and participants

In this cohort study, cochlear implants at Samsung Medical Center, a tertiary referral center, were retrospectively reviewed. Patients who underwent CI surgery from October 2001 to March 2019 were included. In the device survival analysis, the first revision surgery was considered the primary event, and the end point of observation was June 1, 2019.

Interventions

Therapeutic and rehabilitative CI surgery.

Main outcomes and measures

The revision surgery rate, reasons for revision surgery, and the failure and survival rates of different device models were analyzed. The Kaplan-Meier method and the log-rank test were used to present both the device survival and cumulative survival curves with rates.

Results

In this study, 43 of 925 patients with CIs (4.6%) underwent a revision surgery. Device failure was the most common reason (28 of 43 patients [65%]). Flap-associated problems and migration of the inner device were the next most important reasons (4 of 43 [9.3%] each). Overall, the 10-year cumulative survival rate of CI surgery was 94.4%, and the device survival rate was 96.0%. Thirteen different CI devices from 4 different manufacturers were implanted, and no meaningful differences in device failure were found among CI manufacturers or devices (hazard ratios for cumulative survival: Cochlear, 1.67 [95% CI, 0.72-3.88]; Advanced Bionics, 1.67 [95% CI, 0.61-4.53]; Med-El, reference; hazard ratios for device survival: Cochlear, 1.65 [95% CI, 0.55-4.99]; Advanced Bionics, 1.93 [95% CI, 0.56-6.74]; Med-El, reference). Several recalls were issued by manufacturers during the study period, and after excluding the recalled devices, the device survival rates for 5, 10, and 15 years were 98.2%, 97.7%, and 94.9%, respectively.

Conclusions and relevance

Generally, implanted devices remain safe and stable for a long time, and no significant differences in survival rates were found between device types or manufacturers. Device failure was the main reason for CI revision, followed by flap-associated problems and migration of the inner device.

SUBMITTER: Kim SY

PROVIDER: S-EPMC7059107 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Publications

Evaluating Reasons for Revision Surgery and Device Failure Rates in Patients Who Underwent Cochlear Implantation Surgery.

Kim So Yeon SY Kim Min Bum MB Chung Won-Ho WH Cho Yang-Sun YS Hong Sung Hwa SH Moon Il Joon IJ

JAMA otolaryngology-- head & neck surgery 20200501 5

<h4>Importance</h4>Understanding the reasons for cochlear implant (CI) revision surgery and device failure rates is important for clinicians when counseling patients who are considering CI.<h4>Objectives</h4>To analyze the revision surgery rate, reasons for revision surgery, and device failure and survival rates of different device models in recipients of CIs.<h4>Design, setting, and participants</h4>In this cohort study, cochlear implants at Samsung Medical Center, a tertiary referral center, w ...[more]

PMID: 32134441

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Project description:BackgroundIn order to preserve residual hearing in patients with sensorineural hearing loss (SNHL) who receive a cochlear implant (CI), insertion trauma to the delicate structures of the cochlea needs to be minimized. The surgical approach comprises the conventional mastoidectomy-posterior tympanotomy (MPT) to arrive at the middle ear, followed by either a cochleostomy (CO) or the round window (RW) approach. Both techniques have their benefits and disadvantages. Another important aspect in structure preservation is the design of the electrode array. Two different designs are used: a "straight" lateral wall lying electrode array (LW) or a "pre-curved" perimodiolar lying electrode array (PM). Interestingly, until now, the best surgical approach and design of the implant is uncertain. Our hypothesis is that there is a difference in hearing preservation outcomes between the four possible treatment options.MethodsWe designed a monocenter, multi-arm, randomized controlled trial to compare insertion trauma between four groups of patients, with each group having a unique combination of an electrode array type (LW or PM) and surgical approach (RW or CO). In total, 48 patients will be randomized into one of these four intervention groups. Our primary objective is the comparison of postoperative hearing preservation between these four groups. Secondly, we aim to assess structure preservation (i.e., scalar translocation, with basilar membrane disruption or tip fold-over of array) for each group. Thirdly, we will compare objective outcomes of hearing and structure preservation by way of electrocochleography (ECochG).DiscussionCochlear implantation by way of a cochleostomy or round window approach, using different electrode array types, is the standard medical care for patients with severe to profound bilateral sensorineural hearing loss, as it is a relatively simple and low-risk procedure that greatly benefits patients. However, loss of residual hearing remains a problem. This trial is the first randomized controlled trial that evaluates the effect of cochlear insertion trauma of several CI treatment options on hearing preservation.Trial registrationNetherlands Trial Register (NTR) NL8586 . Registered on 4 May 2020. Retrospectively registered; 3/48 participants were included before registration.

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Dataset Information

Evaluating Reasons for Revision Surgery and Device Failure Rates in Patients Who Underwent Cochlear Implantation Surgery.

Importance

Objectives

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Publications

Evaluating Reasons for Revision Surgery and Device Failure Rates in Patients Who Underwent Cochlear Implantation Surgery.

Similar Datasets

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