title: Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea in a Multicenter German Postmarket Study.
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/m2). 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.
authors.affiliation: 1 Department of Otorhinolaryngology-Head and Neck Surgery, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
authors.forename: Clemens
authors.initials: C
authors.lastname: Heiser
authors.affiliation: 2 Department of Otorhinolaryngology-Head and Neck Surgery, University-Hospital Mannheim, Mannheim, Germany.
authors.forename: Joachim T
authors.initials: JT
authors.lastname: Maurer
authors.affiliation: 1 Department of Otorhinolaryngology-Head and Neck Surgery, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
authors.forename: Benedikt
authors.initials: B
authors.lastname: Hofauer
authors.affiliation: 2 Department of Otorhinolaryngology-Head and Neck Surgery, University-Hospital Mannheim, Mannheim, Germany.
authors.forename: J Ulrich
authors.initials: JU
authors.lastname: Sommer
authors.affiliation: 3 Department of Otorhinolaryngology, University of Lübeck, Lübeck, Germany.
authors.forename: Annemarie
authors.initials: A
authors.lastname: Seitz
authors.affiliation: 3 Department of Otorhinolaryngology, University of Lübeck, Lübeck, Germany.
authors.forename: Armin
authors.initials: A
authors.lastname: Steffen
mesh_terms: D000328:Adult; D000368:Aged; D004599:Electric Stimulation Therapy / Q000295:instrumentation*; D005260:Female; D005858:Germany; D006801:Humans; D007002:Hypoglossal Nerve / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D000071066:Patient Reported Outcome Measures; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D019736:Prostheses and Implants; D020181:Sleep Apnea, Obstructive / Q000503:physiopathology* / Q000601:surgery*; D016896:Treatment Outcome
keywords: German postmarket study; hypoglossal nerve; obstructive sleep apnea; selective upper airway stimulation; surgical treatment