Department of Otolaryngology-Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, China.
These authors are co-first authors who have contributed equally to this work.
Ear Hear. 2023;44(1):43-52. doi: 10.1097/AUD.0000000000001266. Epub 2022 Aug 15.
In terms of cochlear reimplantation, there is no consensus on the definition, range, or calculation formulation for the reimplantation rate. This study aims to put forward a relatively standardized and more explicit definition based on a literature review, calculate the rate of cochlear reimplantation, and examine the classification and distribution of the reimplantation causes.
A systematic review and retrospective study. A relatively clearer definition was used in this study: cochlear reimplantation is the implantation of new electrodes to reconstruct the auditory path, necessitated by the failure or abandonment of the initial implant. Seven English and Chinese databases were systematically searched for studies published before July 23, 2021 regarding patients who accepted cochlear reimplantation. Two researchers independently applied the inclusion and exclusion criteria to select studies and complete data extraction. As the effect size, the reimplantation rate was extracted and synthesized using a random-effects model, and subgroup and sensitivity analyses were performed to reduce heterogeneity. In addition, a retrospective study analyzed data on cochlear reimplantation in a tertiary hospital from April 1999 to August 2021. Kaplan-Meier survival analysis and the log-rank test were adopted to analyze the survival times of cochlear implants and compare them among different subgroups.
A total of 144 articles were included, with 85,851 initial cochlear implantations and 4276 cochlear reimplantations. The pooled rate of cochlear reimplantation was 4.7% [95% CI (4.2% to 5.1%)] in 1989 to 2021, 6.8% [95% CI (4.5% to 9.2%)] before 2000, and 3.2% [95% CI (2.7% to 3.7%)] after 2000 ( P =0.003). Device failures accounted for the largest proportion of reimplantation (67.6% [95% CI (64.0% to 71.3%)], followed by medical reasons (28.9% [95% CI (25.7% to 32.0%)]). From April 1999 to August 2021, 1775 cochlear implants were performed in West China Hospital (1718 initial implantations and 57 reimplantations; reimplantation rate 3.3%). In total, 45 reimplantations (78.9%) were caused by device failure, 10 (17.5%) due to medical reasons, and 2 (3.5%) from unknown reasons. There was no difference in the survival time of implants between adults and children ( P = 0.558), while there existed a significant difference between patients receiving implants from different manufacturers ( P < 0.001).
The cochlear reimplantation rate was relatively high, and more attention should be paid to formulating a standard definition, calculation formula, and effect assessment of cochlear reimplantation. It is necessary to establish a sound mechanism for long-term follow-up and rigorously conduct longitudinal cohort studies.
在耳蜗再植入方面，对于再植入率的定义、范围或计算公式尚未达成共识。本研究旨在基于文献回顾提出一个相对标准化且更明确的定义，计算耳蜗再植入率，并研究再植入原因的分类和分布。
系统评价和回顾性研究。本研究采用了一个相对更清晰的定义：由于初始植入物的失败或放弃，需要重新植入新的电极以重建听觉通路，即为耳蜗再植入。系统检索了 2021 年 7 月 23 日前发表的关于接受耳蜗再植入患者的英文和中文数据库中的研究。两名研究人员独立应用纳入和排除标准筛选研究并完成数据提取。作为效应量，采用随机效应模型提取和综合再植入率，并进行亚组和敏感性分析以减少异质性。此外，还进行了一项回顾性研究，分析了 1999 年 4 月至 2021 年 8 月期间某三级医院的耳蜗再植入数据。采用 Kaplan-Meier 生存分析和对数秩检验分析耳蜗植入物的生存时间，并比较不同亚组之间的差异。
共纳入 144 篇文章，其中包括 85851 例初始耳蜗植入和 4276 例耳蜗再植入。1989 年至 2021 年的总体再植入率为 4.7%[95%置信区间（4.2%至 5.1%）]，2000 年前为 6.8%[95%置信区间（4.5%至 9.2%）]，2000 年后为 3.2%[95%置信区间（2.7%至 3.7%）]（P=0.003）。设备故障是再植入的最大原因（67.6%[95%置信区间（64.0%至 71.3%）]），其次是医疗原因（28.9%[95%置信区间（25.7%至 32.0%）]）。2019 年 4 月至 2021 年 8 月期间，我院共进行了 1775 例耳蜗植入术（1718 例初始植入，57 例再植入；再植入率为 3.3%）。总共 45 例（78.9%）再植入是由于设备故障引起的，10 例（17.5%）是由于医疗原因，2 例（3.5%）是由于不明原因。成人和儿童的植入物存活时间无差异（P=0.558），而不同制造商生产的植入物之间存在显著差异（P<0.001）。
耳蜗再植入率相对较高，应更加重视耳蜗再植入的标准定义、计算公式和效果评估。有必要建立健全的长期随访机制，并严格进行纵向队列研究。
