Novel Outcome Analysis Tool for Hypoglossal Nerve Stimulator Sensor Lead Function and Comparison by Incision Type (2 Versus 3)

Abstract

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.