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Sleep Breath. 2019 Sep 4. doi: 10.1007/s11325-019-01933-0. [Epub ahead of print]

Long-term follow-up of the German post-market study for upper airway stimulation for obstructive sleep apnea.

Author information

1
Department of Otorhinolaryngology, University of Lübeck, Klinik für HNO-Heilkunde, Ratzeburger Allee 160, 23538, Lübeck, Germany. armin.steffen@uksh.de.
2
Department of Otorhinolaryngology, Head and Neck Surgery, Helios University Hospital Wuppertal, University Witten/Herdecke, Wuppertal, Germany.
3
Department of Otorhinolaryngology, Head and Neck Surgery, University-Hospital Mannheim, Mannheim, Germany.
4
Department of Otorhinolaryngology, University of Lübeck, Klinik für HNO-Heilkunde, Ratzeburger Allee 160, 23538, Lübeck, Germany.
5
Department of Otorhinolaryngology, University of Freiburg, Kilianstraße 5, 79106, Freiburg, Germany.
6
Department of Otorhinolaryngology, Head and Neck Surgery, Technische Universität München, Munich, Germany.

Abstract

PURPOSE:

Upper airway stimulation (UAS) is an effective treatment for obstructive sleep apnea (OSA) in positive airway pressure (PAP) failure. Most reports have presented short-term data, so long-term safety and efficacy reports are rare. The German post-market study (G-PMS) has followed approximately 60 patients from three implanting centers for several years.

METHODS:

Patients with OSA and PAP failure qualified for the G-PMS by the absence of obesity class 2 an AHI between 15 and 65 events/h and absence of complete concentric collapse at the velum during drug-induced sleep endoscopy. Optional 2- and 3-year follow-ups after implantation were collected during routine clinical practice. We measured respiratory parameters such as apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) and daytime sleepiness using the Epworth sleepiness scale (ESS) in a per protocol analysis. Usage was calculated from device-downloaded reports. Device-related complications were documented.

RESULTS:

Of the 60 original patients, 41 returned for 2-year follow-up, and 38 for 3 years. About 76% at 2 years and 68% at 3 years met the criterion of therapy success defined as an AHI below 15/h. The median AHI was reduced from 28.6/h (baseline) to 9.0/h (2 years) and 10.0/h (3 years); whereas median ODI decreased from 27.0 to 6.3/h (2 years), and 8.3/h (3 years). Median ESS improved from baseline 13 points to 4 (2 years) and 6 (3 years). Usage was stable at approximately 45 h per week at 2 and 3 years. Serious device-related adverse events were rare, with two-device explantation between 12 to 36 months postoperatively.

CONCLUSIONS:

The German multi-center long-term outcomes compare favorably with previously published studies. Respiratory and sleepiness efficacy outcomes were sustained over 2 and 3 years, with a favorable safety profile, supporting the safety and efficacy of a chronic implantable therapy.

KEYWORDS:

Device; Hypoglossal nerve stimulation; Long term; Obstructive sleep apnea; PAP failure; Surgery; Upper airway stimulation

PMID:
31485853
DOI:
10.1007/s11325-019-01933-0

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