Upper airway stimulation for obstructive sleep apnea: 5-year outcomes

ObjectiveTo present 5-year outcomes from a prospective cohort of patients with obstructive sleep apnea (OSA) who were treated with upper airway stimulation (UAS) via a unilateral hypoglossal nerve implant.Study DesignA multicenter prospective cohort study.SettingIndustry-supported multicenter academ...

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Hauptverfasser: Woodson, B. Tucker (VerfasserIn) , Maurer, Joachim T. (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: March 27, 2018
In: Otolaryngology - head and neck surgery
Year: 2018, Jahrgang: 159, Heft: 1, Pages: 194-202
ISSN:1097-6817
DOI:10.1177/0194599818762383
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1177/0194599818762383
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Verfasserangaben:B. Tucker Woodson, Kingman P. Strohl, Ryan J. Soose, M. Boyd Gillespie, Joachim T. Maurer, Nico de Vries, Tapan A. Padhya, M. Safwan Badr, Ho-sheng Lin, Olivier M. Vanderveken, Sam Mickelson, and Patrick J. Strollo

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520 |a ObjectiveTo present 5-year outcomes from a prospective cohort of patients with obstructive sleep apnea (OSA) who were treated with upper airway stimulation (UAS) via a unilateral hypoglossal nerve implant.Study DesignA multicenter prospective cohort study.SettingIndustry-supported multicenter academic and clinical trial.MethodsFrom a cohort of 126 patients, 97 completed protocol, and 71 consented to a voluntary polysomnogram. Those having continuous positive airway pressure failure with moderate to severe OSA, body mass index <32 kg/m2, and no unfavorable collapse on drug-induced sleep endoscopy were enrolled in a phase 3 trial. Prospective outcomes included apnea-hypopnea index (AHI), oxygen desaturation index, and adverse events, as well as measures of sleepiness, quality of life, and snoring.ResultsPatients who did and did not complete the protocol differed in baseline AHI, oxygen desaturation index, and Functional Outcomes of Sleep Questionnaire scores but not in any other demographics or treatment response measures. Improvement in sleepiness (Epworth Sleepiness Scale) and quality of life was observed, with normalization of scores increasing from 33% to 78% and 15% to 67%, respectively. AHI response rate (AHI <20 events per hour and >50% reduction) was 75% (n = 71). When a last observation carried forward analysis was applied, the responder rate was 63% at 5 years. Serious device-related events all related to lead/device adjustments were reported in 6% of patients.ConclusionsImprovements in sleepiness, quality of life, and respiratory outcomes are observed with 5 years of UAS. Serious adverse events are uncommon. UAS is a nonanatomic surgical treatment with long-term benefit for individuals with moderate to severe OSA who have failed nasal continuous positive airway pressure. 
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