Hypoglossal Nerve Stimulator Outcomes for Patients Outside the U.S. FDA Recommendations.
Food and Drug Administration
Obstructive sleep apnea
hypoglossal nerve stimulator
neurostimulation
surgery for obstructive sleep apnea
Journal
The Laryngoscope
ISSN: 1531-4995
Titre abrégé: Laryngoscope
Pays: United States
ID NLM: 8607378
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
18
04
2019
revised:
28
05
2019
accepted:
18
06
2019
pubmed:
11
7
2019
medline:
18
8
2020
entrez:
11
7
2019
Statut:
ppublish
Résumé
The hypoglossal nerve stimulator (HGNS) is currently approved for the treatment of obstructive sleep apnea (OSA) in patients with an apnea-hypopnea index (AHI) of >15 to ≤65 events/hour, and a central apnea index (CAI) <25% of the AHI, no complete concentric collapse on drug-induced sleep endoscopy, and a recommended body mass index (BMI) <32 kg/m We included all patients who underwent HGNS but who did not meet all FDA guidelines. Demographic data, previous OSA treatments, polysomnographic (PSG) parameters from baseline and HGNS titration PSG, Epworth sleepiness score (ESS), and BMI were compared before and after surgery. Eighteen patients were identified: 94.4% male, median age 63 years. Seven underwent previous sleep surgery. Four had an AHI <15 (mean 10.5 events/hour), four had an AHI >65 (mean 86.9 events/hour), two had an elevated CAI (mean 31.3% of AHI), and 12 had a BMI >32 kg/m Our success rate for patients outside the Food and Drug Administration guidelines for HGNS (67%) was similar to the 1-year STAR trial results (66%). Future studies are necessary to consider expansion of these guidelines. 4 Laryngoscope, 130:866-872, 2020.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
866-872Informations de copyright
© 2019 The American Laryngological, Rhinological and Otological Society, Inc.
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