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Otolaryngol Head Neck Surg. 2018 Jul;159(1):194-202. doi: 10.1177/0194599818762383. Epub 2018 Mar 27.

Upper Airway Stimulation for Obstructive Sleep Apnea: 5-Year Outcomes.

Author information

1
1 Department of Otolaryngology and Human Communication, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
2
2 Department of Pulmonary, Critical Care and Sleep Medicine, Cleveland VA Medical Center, Cleveland, Ohio, USA.
3
3 Department of Otolaryngology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
4
4 Department of Otolaryngology-Head and Neck Surgery, University of Tennessee Health Science Center, Memphis, Tennessee, USA.
5
5 Department of Otorhinolaryngology-Head and Neck Surgery, Sleep Disorders Center, University Hospital Mannheim, Mannheim, Germany.
6
6 Department of Otolaryngology, OLVG Hospital and ACTA, Amsterdam, Netherlands.
7
7 Department of Otorhinolaryngology and Head and Neck Surgery, Multidisciplinary Sleep Disorders Center, University of Antwerp, Antwerp, Belgium.
8
8 Department of Otolaryngology-Head and Neck Surgery, College of Medicine, University of South Florida, Tampa, Florida, USA.
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9 Department of Internal Medicine, Wayne State University Health Center, Detroit, Michigan, USA.
10
10 Department of Otolaryngology-Head and Neck Surgery, Wayne State University Health Center, Detroit, Michigan, USA.
11
11 Advanced ENT Associates, Atlanta, Georgia, USA.
12
12 Division of Pulmonary Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

Abstract

Objective To 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 Design A multicenter prospective cohort study. Setting Industry-supported multicenter academic and clinical trial. Methods From 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. Results Patients 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. Conclusions Improvements 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.

KEYWORDS:

cranial nerve; device; device apnea hypopnea index; hypoglossal nerve; implant; long term; obstructive sleep apnea; polysomnogram; quality of life; sleep; sleepiness; surgery; upper airway stimulation

PMID:
29582703
DOI:
10.1177/0194599818762383
[Indexed for MEDLINE]

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