Samsung Hearing Laboratory, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Samsung Medical Center, Department of Otorhinolaryngology-Head and Neck Surgery, Sungkyunkwan University School of Medicine, Seoul, Korea.
JAMA Otolaryngol Head Neck Surg. 2020 May 1;146(5):414-420. doi: 10.1001/jamaoto.2020.0030.
Understanding the reasons for cochlear implant (CI) revision surgery and device failure rates is important for clinicians when counseling patients who are considering CI.
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.
Therapeutic and rehabilitative CI surgery.
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.
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.
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.
了解人工耳蜗（CI）翻修手术和设备失败率的原因对于考虑 CI 的患者的临床医生来说非常重要。
分析不同设备模型在接受 CI 患者中的翻修手术率、翻修手术原因、设备失败和设备存活率。
设计、地点和参与者：在这项队列研究中，回顾了三星医疗中心的人工耳蜗植入情况。该研究纳入了 2001 年 10 月至 2019 年 3 月期间接受 CI 手术的患者。在设备生存分析中，第一次翻修手术被认为是主要事件，观察终点为 2019 年 6 月 1 日。
治疗和康复性 CI 手术。
分析了翻修手术率、翻修手术原因以及不同设备模型的失败和存活率。使用 Kaplan-Meier 方法和对数秩检验来呈现设备生存率和累积生存率曲线以及率。
在这项研究中，925 名接受 CI 治疗的患者中有 43 名（4.6%）接受了翻修手术。设备故障是最常见的原因（28 名患者[65%]）。瓣相关问题和内部设备的迁移是下一个最重要的原因（各有 4 名患者[9.3%]）。总的来说，CI 手术的 10 年累积生存率为 94.4%，设备生存率为 96.0%。共植入了来自 4 家不同制造商的 13 种不同的 CI 设备，不同 CI 制造商或设备之间的设备故障率没有明显差异（累积生存率的危害比：科利尔，1.67[95%CI，0.72-3.88]；高级仿生学，1.67[95%CI，0.61-4.53]；Med-El，参考；设备生存率的危害比：科利尔，1.65[95%CI，0.55-4.99]；高级仿生学，1.93[95%CI，0.56-6.74]；Med-El，参考）。在研究期间，制造商发布了几次召回通知，在排除召回设备后，5、10 和 15 年的设备生存率分别为 98.2%、97.7%和 94.9%。
一般来说，植入设备可以长时间保持安全和稳定，并且在设备类型或制造商之间没有发现生存率的显著差异。设备故障是 CI 翻修的主要原因，其次是瓣相关问题和内部设备的迁移。
