5-year follow-up of the German Postmarket Study – Upper airway stimulation in obstructive sleep apnea

Introduction Selective upper airway stimulation has been established as an effective second line treatment for obstructive sleep apnea (OSA). Most publications report on 1-year data and long-term data are lacking. The prospective German Post-Market Study enrolled 60 patients from 3 centers who were followed for 60 months in clinical routine.

Patients and methods OSA patients with failed PAP-therapy, a Body-Mass-Index < 35 kg/m², an apnea-hypopnea-index (AHI) from 15-65/h, and without a complete concentric collaps during drug-induced sleep endoscopy were enrolled. 4- and 5-year results were analyzed, comprising of AHI, oxygen desaturation index (ODI) and Epworth Sleepiness Scale (ESS). The patients‘ remote control delivered weekly usage.

Results Of the 60 patients enrolled we could collect 4- and 5-year results in 20 and 15 patients, respectively. Median AHI dropped from initially 29/h to 11/h and 16/h, median ODI from 27/h to 8/h and 8/h, respectively. Daytime sleepiness was reduced from a median of 13 to 6 and 4 assessed by the ESS. Weekly usage remained stable with 41 and 44 hours, respectively. The system was explanted in 2 patients, the sensor electrode was changed in 3 patients.

Conclusion 5-year data show a good reduction of OSA and und a high usage in clinical routine. A regular long-term follow-up regarding efficacy and safety is necessary.

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Publication History

Article published online:
13 May 2021