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Long-term Follow-up of the German Post-Market-Study for Upper Airway Stimulation for Obstructive Sleep Apnea
Upper airway stimulation (UAS) is an effective treatment for Obstructive Sleep Apnea (OSA) in 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 patients from three implanting centers for several years.
Patients with OSA and PAP-failure qualified for the G-PMS by the absence of obesity class 2, an AHI between 15-65 events/hour, and absence of complete concentric collapse at the velum during drug-induced sleep endoscopy. Optional two and three years-follow-up after implantation was collected during routine clinical practice. We measured Apnea-Hypopnea-Index (AHI) and Oxygen-Desaturation-Index (ODI), and daytime sleepiness using the Epworth Sleepiness Scale (ESS). Usage was calculated from device downloaded reports. Device-related complications were documented.
Of the 60 original patients, 41 returned for two-year follow-up, and 38 for three-years. About 76 % at two-year and 68 % at three years met the criterion of therapy success defined as an AHI below 15/h. The median AHI was reduced from 28.6/h to 9.0/h (two-years) and 10.0/h (three-years); whereas median ODI decreased from 27.0/h to 6.3/h (two-years), and 8.3/h (three-years). Median ESS improved from baseline 13 points to 4 (two-years) and 6 (three years). Usage was stable at about 45 hours per week at 2 and 3 years. Serious device-related adverse events were rare, with two device explantation between 12 to 36 months post-operatively.
The German multi-center long-term outcomes compare favorably to previously published studies. Respiratory and sleepiness efficacy outcomes were sustained over two and three years, with a favorable safety profile, supporting the safety and efficacy of a chronic implantable therapy.
Article published online:
10 June 2020
© 2020. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).
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