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

  • Sleep Breathing Physiology and Disorders • Original Article
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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.

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Acknowledgments

The authors would like to express their gratitude to the study nurses and colleagues of the local sleep laboratories Katharina Eckbauer, Nicole Behn, Oliver Schmidt, and Sabrina Sihman for their commitment in collecting the necessary data for this study. Underlying data for the 1-year evaluation from German post-market study was furnished by Inspire Medical Systems, Inc.

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Authors and Affiliations

  1. Department of Otorhinolaryngology, University of Lübeck, Klinik für HNO-Heilkunde, Ratzeburger Allee 160, 23538, Lübeck, Germany

    Armin Steffen & Nils Abrams

  2. Department of Otorhinolaryngology, Head and Neck Surgery, Helios University Hospital Wuppertal, University Witten/Herdecke, Wuppertal, Germany

    Ulrich J. Sommer

  3. Department of Otorhinolaryngology, Head and Neck Surgery, University-Hospital Mannheim, Mannheim, Germany

    Joachim T. Maurer

  4. Department of Otorhinolaryngology, University of Freiburg, Kilianstraße 5, 79106, Freiburg, Germany

    Benedikt Hofauer

  5. Department of Otorhinolaryngology, Head and Neck Surgery, Technische Universität München, Munich, Germany

    Clemens Heiser

Authors
  1. Armin Steffen
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  2. Ulrich J. Sommer
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  3. Joachim T. Maurer
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  4. Nils Abrams
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  5. Benedikt Hofauer
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Corresponding author

Correspondence to Armin Steffen.

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Conflict of interest

Armin Steffen, Ulrich J. Sommer, Joachim T. Maurer and Clemens Heiser are study investigators and received honoraria and travel expenses for invited talks on behalf of Inspire Medical, Inc., outside the submitted work. Clemens Heiser is a consultant for Inspire Medical Systems. Benedikt Hofauer received travel expenses from Inspire Medical, Inc. Nils Abrams has nothing to declare.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The German post-market study was approved by the ethics committee at all three institutions and was registered as NCT02293746 on clinicaltrials.gov.

Informed consent

Informed consent was obtained from all individual participants included in the German post-market study.

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Steffen, A., Sommer, U.J., Maurer, J.T. et al. Long-term follow-up of the German post-market study for upper airway stimulation for obstructive sleep apnea. Sleep Breath 24, 979–984 (2020). https://doi.org/10.1007/s11325-019-01933-0

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  • DOI: https://doi.org/10.1007/s11325-019-01933-0

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