Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea in a Multicenter German Postmarket Study. (February 2017)

• Record Type: Journal Article
• Authors: Heiser, Clemens; Maurer, Joachim T.; Hofauer, Benedikt; Sommer, J. Ulrich; Seitz, Annemarie; Steffen, Armin
• Is Part Of: Otolaryngology--head and neck surgery. Volume 156:Number 2(2017)
• Page Start: 378
• Page End: 384
• Publication Date: 2017-02
• Subjects: obstructive sleep apnea -- surgical treatment -- hypoglossal nerve -- selective upper airway stimulation -- German postmarket study; Head -- Surgery -- Periodicals; Neck -- Surgery -- Periodicals; Otolaryngology -- Periodicals; 617.51
• DOI: 10.1177/0194599816683378
• Languages: English
• ISSNs: 0194-5998

Abstract

Objective: Selective stimulation of the hypoglossal nerve is a new surgical therapy for obstructive sleep apnea, with proven efficacy in well-designed clinical trials. The aim of the study is to obtain additional safety and efficacy data on the use of selective upper airway stimulation during daily clinical routine. Study Design: Prospective single-arm study. Setting: Three tertiary hospitals in Germany (Munich, Mannheim, Lübeck). Subjects and Methods: A multicenter prospective single-arm study under a common implant and follow-up protocol took place in 3 German centers (Mannheim, Munich, Lübeck). Every patient who received an implant of selective upper airway stimulation was included in this trial (apnea-hypopnea index ≥15/h and ≤65/h and body mass index <35 kg/m 2 ). Before and 6 months after surgery, a 2-night home sleep test was performed. Data regarding the safety and efficacy were collected. Results: From July 2014 through October 2015, 60 patients were included. Every subject reported improvement in sleep and daytime symptoms. The average usage time of the system was 42.9 ± 11.9 h/wk. The median apnea-hypopnea index was significantly reduced at 6 months from 28.6/h to 8.3/h. No patient required surgical revision of the implanted system. Conclusion: Selective upper airway stimulation is a safe and effective therapy for patients with obstructive sleep apnea and represents a powerful option for its surgical treatment.