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耳蜗内测试电极在听神经瘤手术中进行听神经监测的诊断准确性。

Diagnostic Accuracy of Intracochlear Test Electrode for Acoustic Nerve Monitoring in Vestibular Schwannoma Surgery.

机构信息

Otolaryngology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.

Otolaryngology Department, Hospital Universitario Germans Trias i Pujol, Barcelona, Spain.

出版信息

Ear Hear. 2020 Nov/Dec;41(6):1648-1659. doi: 10.1097/AUD.0000000000000883.

Abstract

OBJECTIVES

Cochlear implants (CIs) are a well-known hearing restoration option for patients with vestibular schwannoma (VS) in cases of neurofibromatosis type-2 and, more recently, for patients with sporadic VS. One of the main limitations when performing CI during VS surgery is the capability to preserve the acoustic nerve (AN) anatomically and functionally. Significant efforts have been directed toward developing an intraoperative testing method for monitoring the AN function to determine if, after tumor removal, it is suitable for conducting stimuli delivered by a CI. However, all these methods have significant limitations, and none of them have documented diagnostic efficacy. To overcome these limitations and to obtain reliable information before CI insertion, a minimally invasive intracochlear test electrode (TE) has been recently developed. This TE has demonstrated to be suitable to test the integrity of the AN before CI in patients without any residual hearing by recording electrically evoked auditory brainstem responses (EABR). The present study constitutes the next phase of this research, which was to determine the usefulness of EABR obtained intraoperatively with the intracochlear TE after the resection of a VS and to calculate its diagnostic accuracy to assess the functionality of the AN for CI.

DESIGN

This was a prospective, multicenter study of diagnostic accuracy. It was conducted in three tertiary referral centers between January 2015 and 2018. This study was designed following the Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement guidelines. The STARD statement are guidelines to improve the completeness and transparency of reports of diagnostic accuracy studies. The diagnostic accuracy of the EABR evoked with the intracochlear TE after tumor removal was studied. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value were calculated. Patients eligible for the study were consecutive adults undergoing surgery for VS with simultaneous CI. The test under evaluation (index test) was the EABR obtained with the intracochlear TE after resection of the tumor. The reference test (gold standard) was the presence of auditory perception with the CI, defined as the presence of sound detection on an audiogram at 500, 1000, 2000, and 4000 Hz of no greater than 50 dB. In all the cases, auditory perception was verified by the presence of a positive EABR evoked with the CI.

RESULTS

Twenty-one patients were included during the study period; seven patients were excluded from the diagnostic efficacy analysis due to inconclusive EABR results or absence of the gold standard to compare (they did not finally receive the CI). Thus, the outcome of the gold standard was assessed in 14 cases: 9 cases had positive EABR, all of them obtained auditory perception with the CI, and 5 cases had negative EABR, only one case had auditory perception with the CI, which constitutes the only false negative of this study. Accuracy of the TE was 93% (95% confidence interval, 66 to 100%), sensitivity 90% (95% confidence interval, 71 to 100%), specificity 100% (95% confidence interval, 100 to 100%), positive predictive value 100% (95% confidence interval, 100 to 100%), and negative predictive value 80% (95% confidence interval, 45 to 100%).

CONCLUSIONS

EABR elicited with the intracochlear TE had a diagnostic accuracy of 93% for predicting auditory perception with CIs after VS removal. These results suggest that the intracochlear TE can be used intraoperatively after tumor removal to test the integrity of the AN as a useful tool to complement the surgeon's perception for decision-making regarding implantation.

摘要

目的

对于神经纤维瘤病 2 型患者和最近的散发性听神经鞘瘤(VS)患者,人工耳蜗(CI)是一种众所周知的听力恢复选择。在 VS 手术中进行 CI 时的主要限制之一是能够在解剖学和功能上保留听神经(AN)。为了开发一种用于监测 AN 功能的术中测试方法,以确定在肿瘤切除后是否适合进行 CI 传递的刺激,已经进行了大量努力。然而,所有这些方法都有显著的局限性,而且没有一种方法具有明确的诊断效果。为了克服这些限制,并在插入 CI 之前获得可靠的信息,最近开发了一种微创耳蜗内测试电极(TE)。该 TE 通过记录电诱发听觉脑干反应(EABR),已被证明适合在没有任何残余听力的情况下,对接受 CI 的患者进行 CI 前 AN 完整性测试。本研究构成了该研究的下一个阶段,旨在确定在 VS 切除后使用耳蜗内 TE 获得的 EABR 的有用性,并计算其诊断准确性,以评估 AN 的 CI 功能。

设计

这是一项具有诊断准确性的前瞻性、多中心研究。它于 2015 年至 2018 年在三个三级转诊中心进行。本研究遵循诊断准确性研究报告的标准(STARD)声明指南。STARD 声明是提高诊断准确性研究报告的完整性和透明度的指南。研究了肿瘤切除后使用耳蜗内 TE 诱发的 EABR 的诊断准确性。计算了准确性、灵敏度、特异性、阳性预测值和阴性预测值。本研究纳入的患者为连续接受 VS 手术并同时进行 CI 的成年人。评估的测试(索引测试)是肿瘤切除后使用耳蜗内 TE 获得的 EABR。参考测试(金标准)是 CI 检测到的听觉感知,定义为在 500、1000、2000 和 4000 Hz 处不超过 50 dB 的听力图上存在声音检测。在所有情况下,通过 CI 诱发的阳性 EABR 来验证听觉感知的存在。

结果

在研究期间共纳入 21 例患者;由于 EABR 结果不确定或缺乏金标准(他们最终未接受 CI),7 例患者被排除在诊断疗效分析之外。因此,14 例患者评估了金标准的结果:9 例 EABR 阳性,均获得 CI 听觉感知,5 例 EABR 阴性,仅 1 例获得 CI 听觉感知,这是本研究中唯一的假阴性。TE 的准确性为 93%(95%置信区间,66 至 100%),灵敏度为 90%(95%置信区间,71 至 100%),特异性为 100%(95%置信区间,100 至 100%),阳性预测值为 100%(95%置信区间,100 至 100%),阴性预测值为 80%(95%置信区间,45 至 100%)。

结论

EABR 由耳蜗内 TE 引出,对预测 VS 切除后 CI 中的听觉感知具有 93%的诊断准确性。这些结果表明,耳蜗内 TE 可以在肿瘤切除后术中使用,作为一种有用的工具来测试 AN 的完整性,以补充外科医生对植入决策的感知。

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