Comparison of Upper Airway Stimulation Outcomes between Regions and BMI groups from the ADHERE registry

Upper Airway Stimulation (UAS) is a surgical alternative for CPAP-intolerant obstructive sleep apnea, available in the US and in EU countries. The ADHERE Registry is an international study following outcomes through 1-year follow-up (M12). We examined efficacy between regions and baseline BMI.

Subjects who met current therapy indications 15≤AHI≤65 and had AHI outcome at M12 were included in the analysis. Data was group by region (EU vs US), and by BMI (BMI≤32 vs 32Nearly 1600 subjects have been enrolled (11/2019), and 542 subjects have completed M12. The distribution of subjects at M12 was 50 % EU (Germany, Netherlands, Belgium), 50 % US. Both groups had similar improvements in AHI (EU 33 to10, US 34 to10), and ESS (EU 12 to7; US 11 to6), and similar Sher response ratios (EU 71 %, US 68 %). The AHI and ESS difference between regions was within the equivalence margin AHI: 0.34,CI[-1.78,2.46], ESS 0.57, CI[-0.04,1.19].

The majority of subjects had a BMI≤32, and 17 % had BMI between 32-35. The proportion was similar between US and EU (p=n.s.). When comparing BMI≤32 versus BMI 32-35, change in AHI from baseline to treatment AHI at M12 was equivalent between the groups. There was a significant difference in response rate between the groups using Sher criteria; 72 % vs. 60 % (p = 0.02). Patients with higher BMI were less likely to achieve AHI < 20. Therapeutic ESS scores were equivalent between the groups.

The ADHERE registry continues to demonstrate high efficacy rates for UAS, and the outcomes are similar between the US and EU. While there are differences in Sher criteria response rates between subjects with BMI≤32 and 32

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Publication History

Article published online:
10 June 2020