Department of Otolaryngology-Head and Neck Surgery, Indiana University School of Medicine, Indianapolis, Indiana, U.S.A.
Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Indiana University School of Medicine, Indianapolis, Indiana, U.S.A.
Laryngoscope. 2023 Feb;133(2):423-430. doi: 10.1002/lary.30365. Epub 2022 Aug 26.
No reported outcome measures have been established to evaluate sensor lead function in the hypoglossal nerve stimulator (HNS). This study describes the development of novel functional outcome measures for intraoperative sensor electrode function and compares 2-incision and 3-incision outcomes for HNS.
A retrospective cohort study of 100 consecutive patients who underwent HNS between June 2019 and September 2021. Demographic information, intraoperative findings, and immediate postoperative outcomes were recorded. Structured parameters were developed to compare intraoperative waveforms with six outcome measures utilized: waveform syncing, waveform amplitude, sensory current leakage, shark-fin morphology, cardiac artifact, and overall impression. Two sleep surgeons and two sleep medicine specialists compared all waveforms in a blinded fashion and assigned scores on the Likert Scale.
The cohort included 50 three-incision and 50 two-incision patients. Age, gender, average body mass index, comorbidity profiles, and sleep endoscopy findings did not significantly differ between the two groups. No major complications occurred. The interclass-correlation-coefficient was greater than 0.7 for all comparisons (good to very good interrater reliability). There was no difference in waveform amplitude, cardiac artifact, sensory current leakage, or shark-fin morphology between the two groups. Waveform syncing and overall impression were statistically better in the 2-incision cohort.
This study is the first to define a structured method of HNS sensor electrode outcome measurement and showed consistent measures by surgeons and sleep medicine specialists. This article supports the transition to the 2-incision technique among surgeons for placement of the sensor lead. Consideration should be given to utilizing this novel tool in the clinical/research setting and validating these measures moving forward.
3 Laryngoscope, 133:423-430, 2023.
目前尚无评估舌下神经刺激器（HNS）传感器导联功能的报道结果测量指标。本研究描述了用于术中传感器电极功能的新型功能结果测量指标，并比较了 HNS 的两切口和三切口结果。
这是一项回顾性队列研究，纳入了 2019 年 6 月至 2021 年 9 月期间接受 HNS 的 100 例连续患者。记录了人口统计学信息、术中发现和术后即刻结果。制定了结构化参数，以比较术中波形与六种结果测量指标：波形同步、波形幅度、感觉电流泄漏、鲨鱼鳍形态、心脏伪影和总体印象。两名睡眠外科医生和两名睡眠医学专家以盲法比较所有波形，并使用 Likert 量表对其进行评分。
该队列包括 50 例三切口和 50 例两切口患者。两组患者的年龄、性别、平均体重指数、合并症谱和睡眠内镜检查结果无显著差异。没有发生重大并发症。所有比较的组内相关系数均大于 0.7（观察者间具有良好至非常好的可靠性）。两组之间的波形幅度、心脏伪影、感觉电流泄漏或鲨鱼鳍形态无差异。两切口组的波形同步和总体印象在统计学上更好。
本研究首次定义了 HNS 传感器电极结果测量的结构化方法，并由外科医生和睡眠医学专家进行了一致的测量。本文支持外科医生向两切口技术过渡，以便放置传感器导联。在临床/研究环境中应考虑使用这种新工具，并在未来验证这些措施。
3 级喉镜，133：423-430，2023 年。
