1575例人工耳蜗电极阵列尖端折叠的评估

文献信息

中文摘要

目的： 人工耳蜗（CI）手术旨在实现无创电极阵列插入，以保留残余听力并优化 outcomes。尖端折叠是插入过程中的一种机械并发症，可能损害刺激效果，并可能需要重新插入或翻修手术。本研究调查了在大量植入各种CI电极阵列设计的患者队列中尖端折叠的发生率、影响因素和诊断方法。
方法： 我们对2013年至2024年间在弗赖堡大学医学中心耳鼻咽喉-头颈外科接受CI手术的成年患者进行了回顾性分析。纳入的电极阵列来自Cochlear™（Slim Straight [SSA]、Slim Modiolar [SMA]、Contour Advance [CA]）、MED-EL（FlexSoft、Flex28、Flex26、Flex24）和Advanced Bionics（SlimJ、Mid Scala [MS]）。对手术报告、术中电生理数据和术后影像学进行了详细审查——由至少两名审查者独立评估。诊断成像方式包括锥形束计算机和数字容积断层扫描（DVT）。
结果： 在1575只植入耳中，检测到13例尖端折叠，总体发生率为0.83%。值得注意的是，其中10例发生在预弯曲、耳蜗周围阵列（SMA和CA，Cochlear™；MS，Advanced Bionics），而仅在直侧壁设计（SSA，Cochlear™）中发现3例。在任何MED-EL电极阵列或Advanced Bionics的SlimJ电极阵列中均未观察到尖端折叠事件。术中跨阻抗矩阵（TIM）分析和术中X射线在解剖结构正常的病例中可靠地检测到尖端折叠。
结论： 电极阵列设计显著影响尖端折叠风险。与柔性直阵列相比，耳蜗周围电极阵列观察到可能更高的发生率。本研究强调了术中诊断的重要性。TIM分析和术中X射线成像被证明可有效实时检测尖端折叠事件，允许立即采取纠正措施并避免翻修手术。这项大规模回顾性研究证实，尖端折叠仍然是CI手术中罕见但重要的并发症，在预弯曲耳蜗周围电极阵列中患病率更高。本研究强调需要对所有CI系统保持持续警惕。

英文摘要

OBJECTIVE: Cochlear implant (CI) surgery aims to achieve atraumatic electrode array insertion to preserve residual hearing and optimize outcomes. Tip fold-over, a mechanical complication during insertion, can compromise stimulation effectiveness and may require reinsertion or revision surgery. This study investigates the incidence, influencing factors, and diagnostic approaches for tip fold-over across a large patient cohort implanted with various CI electrode array designs.
METHODS: We conducted a retrospective analysis of adult patients who underwent CI surgery between 2013 and 2024 at the Department of Otorhinolaryngology-Head and Neck Surgery, Medical Center-University of Freiburg. Included electrode arrays were from Cochlear™ (Slim Straight [SSA], Slim Modiolar [SMA], Contour Advance [CA]), MED-EL (FlexSoft, Flex28, Flex26, Flex24), and Advanced Bionics (SlimJ, Mid Scala [MS]). Detailed reviews of surgical reports, intraoperative electrophysiological data, and postoperative imaging-evaluated independently by at least two reviewers-were performed. Diagnostic imaging modalities included cone beam computed and digital volume tomography (DVT).
RESULTS: Among 1,575 implanted ears, 13 cases of tip fold-over were detected, yielding an overall incidence of 0.83%. Notably, 10 of these occurred with precurved, perimodiolar arrays (SMA and CA, Cochlear™; MS, Advanced Bionics), while only 3 were found in straight lateral wall designs (SSA, Cochlear™). No tip fold-over events were observed with any MED-EL electrode arrays or with the SlimJ electrode array from Advanced Bionics. Intraoperative Transimpedance matrix (TIM) analysis and intraoperative X-ray reliably detected tip fold-over in cases with normal anatomy.
CONCLUSION: Electrode array design significantly influences tip fold-over risk. A potentially higher incidence has been observed with perimodiolar electrode arrays compared with flexible straight arrays. The importance of intraoperative diagnostics is underscored in this study. TIM analysis and intraoperative X-ray imaging proved effective in detecting tip fold-over events in real-time, allowing for immediate corrective action and avoiding revision surgeries. This large-scale retrospective study confirms that tip fold-over remains a rare but significant complication in CI surgery, with a higher prevalence in precurved perimodiolar electrode arrays. This study emphasizes the need for ongoing vigilance across all CI systems.