0577 PATIENT OUTCOMES AND THERAPY ADHERENCE OF UPPER AIRWAY STIMULATION FOR TREATMENT OF OSA: PRELIMINARY RESULTS FROM THE MULTI-CENTER ADHERE REGISTRY

Abstract

Upper airway stimulation (UAS) is an FDA-approved treatment for obstructive sleep apnea (OSA) in patients who cannot adhere to positive airway pressure (CPAP or Bilevel). Controlled clinical trials utilizing UAS have demonstrated a reduction of OSA severity and improvement in patient-reported outcomes. A registry of UAS patients will provide insight into these areas in a real-world setting. We hypothesized that 1) UAS would reduce the AHI to < 10 events/hour over a 12 month period; 2) it would normalize the Epworth Sleepiness Scale scores; and 3) patients would use it for over 6 hours/night. The Adherence and Outcome of UAS for OSA (ADHERE UAS) is an international registry of consecutive patients who have received an implanted UAS system (Inspire Medical Systems, USA). It collects baseline, outcome and adherence data. Outcome measures include the pre- and post-implant AHI and the Epworth Sleepiness Scale (ESS) score. The post-implant AHI is measured during the in-lab polysomnographic (PSG) titration study and at 12-months with PSG or home sleep testing. The Registry is intended to enroll 2,500 patients. As of Dec 15, 2016, 86 participants enrolled in the registry. The mean age was 61.1 ± 11.1 years (84% male) and mean BMI was 29.5 ± 3.7 kg/m2. The AHI was reduced from 38.0 ± 14.2 to 5.1 ± 8.8 and 6.1 ± 4.7 events/h at the titration and 12-month visits respectively (p<0.001 for both visits vs. baseline). After the titration, 69%, 85% and 92% of participants had an AHI of ≤ 5, ≤10, and ≤15 respectively. The ESS changed from 11.5 ± 6.3 to 6.5 ± 4.5 and 6.1 ± 4.1 at the titration and final visits, respectively. Therapy adherence was 6.4 ± 1.8 and 6.1 ± 2.1 hrs/night at the titration and the 12-month visits. Upper airway stimulation reduced OSA severity, and improved daytime sleepiness. Therapy adherence remained high after 12 months among the registry participants who previously could not adhere to CPAP. Support for this study provided by Inspire Medical Systems.