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使用Otoarm-Otodrive系统在人工耳蜗植入中机器人辅助电极插入的早期临床经验。

Early Clinical Experience With Robot-Assisted Electrode Insertion in Cochlear Implantation Using the Otoarm-Otodrive System.

临床研究耳科IF 2.7Q1

文献信息

中文摘要

重要性: 手动人工耳蜗植入(CI)电极插入仍依赖于外科医生,并可能导致耳蜗内创伤。机器人辅助系统,如新型Otoarm-Otodrive,提供超慢速度的电动控制,旨在最小化力度波动和压力变化,从而可能改善听力保留和手术一致性。
目的: 描述使用Otoarm-Otodrive系统进行机器人辅助人工耳蜗植入(CI)的机构经验、手术流程整合及可行性。
设计: 对50例连续机器人辅助CI病例的回顾性描述性研究。
地点: 加拿大一家三级转诊耳科中心。
参与者: 2025年1月至10月期间使用MED-EL设备接受人工耳蜗植入且无耳蜗畸形或骨化的50例成年患者。
干预: 使用Otoarm-Otodrive(MED-EL)系统进行机器人辅助耳蜗电极阵列插入。
主要结局指标: 可行性(设置和插入时间)、插入深度、术中挑战以及融入手术流程的情况。
结果: 机器人设置和对准的额外时间平均为374秒。电极插入持续时间以标准化速率0.1毫米/秒进行,平均为444秒。30例的术后Otoplan分析显示平均角度插入深度为575°。未发生面神经麻痹或感染等重大并发症,也未发生设备相关并发症。除1例外,所有病例均实现完全插入。
结论: 使用Otoarm-Otodrive系统进行机器人辅助耳蜗电极插入安全、可重复,且易于整合到标准CI流程中。
相关性: 这是北美首次使用Otoarm-Otodrive系统的经验,证明了机器人人工耳蜗植入作为实现无创植入一步的可行性。未来研究将评估听力保留益处和成本效益,以促进更广泛采用。

英文摘要

IMPORTANCE: Manual cochlear implant (CI) electrode insertion remains surgeon-dependent and may contribute to intracochlear trauma. Robotic-assisted systems, such as the new Otoarm-Otodrive, offer motorized control at ultra-slow speeds that aim to minimize force fluctuations and pressure changes, potentially improving hearing preservation and surgical consistency.
OBJECTIVE: To describe the institutional experience, surgical workflow integration, and feasibility of robot-assisted cochlear implantation (CI) using the Otoarm-Otodrive system.
DESIGN: Retrospective descriptive study of 50 consecutive robot-assisted CI cases.
SETTING: Tertiary referral otology center in Canada.
PARTICIPANTS: Fifty Adult patients undergoing cochlear implantation without cochlear malformation or ossification using a MED-EL device from January to October 2025.
INTERVENTION: Robot-assisted cochlear electrode array insertion using the Otoarm-Otodrive (MED-EL) system.
MAIN OUTCOME MEASURES: Feasibility (setup and insertion times), insertion depth, intraoperative challenges, and integration into operative workflow.
RESULTS: The additional time for robot setup and alignment averaged 374 seconds. Mean electrode insertion duration, performed at a standardized rate of 0.1 mm/second, was 444 seconds. Postoperative Otoplan analysis in 30 cases demonstrated a mean angular insertion depth of 575°. No major complications such as facial nerve palsy or infections, and no device-related complications occurred. All but 1 case achieved full insertion.
CONCLUSIONS: Robot-assisted cochlear electrode insertion using the Otoarm-Otodrive system is safe, reproducible, and easily integrated into standard CI workflow.
RELEVANCE: This first North American experience in using the Otoarm-Otodrive system demonstrates the feasibility of robotic cochlear implant insertion as a step toward achieving atraumatic implantation. Future studies will assess hearing preservation benefits and cost-effectiveness for broader adoption.