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Device-related outcomes following hypoglossal nerve stimulator implantation
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Journal Article
Device-related outcomes following hypoglossal nerve stimulator implantation
2024
Overview
Study Objectives:
Hypoglossal nerve stimulation (HGNS) has been widely used to treat obstructive sleep apnea in selected patients. Here we evaluate rates of revision and explant related to HGNS implantation and assess types of adverse events contributing to revision and explant.
Methods:
Postmarket surveillance data for HGNS implanted between January 1, 2018 and March 31, 2022, were collected. Event rates and risk were calculated using the postmarket surveillance event counts and sales volume over the same period. Indications were categorized for analysis. Descriptive statistics were reported and freedom from explant or revision curves were grouped by year of implantation.
Results:
Of the 20,881 HGNS implants assessed, rates of explant and revision within the first year were 0.723% and 1.542%, respectively. The most common indication for explant was infection (0.378%) and for revision was surgical correction (0.680%). Of the 5,820 devices with 3-year postimplantation data, the rate of explant was 2.680% and of revision was 3.557%. During this same interval, elective removal (1.478%) was the most common indication, and for revisions, surgical correction (1.134%).
Conclusions:
The efficacy of HGNS is comparable in the real world setting to published clinical trial data. Rates of explant and revision are low, supporting a satisfactory safety profile for this technology.
Citation:
Moroco AE, Wei Z, Byrd I, et al. Device-related outcomes following hypoglossal nerve stimulator implantation.
J Clin Sleep Med
. 2024;20(9):1497–1503.
Publisher
Springer International Publishing,Springer Nature B.V,American Academy of Sleep Medicine
Subject
/ Device Removal - statistics & numerical data
/ Electric Stimulation Therapy - adverse effects
/ Electric Stimulation Therapy - instrumentation
/ Electric Stimulation Therapy - methods
/ Female
/ Humans
/ Implantable Neurostimulators - adverse effects
/ Male
/ Product Surveillance, Postmarketing - statistics & numerical data
/ Reoperation - statistics & numerical data
