Results of the ADHERE upper airway stimulation registry and predictors of therapy efficacy

Abstract

Objective/Hypothesis: The ADHERE Registry is a multicenter prospective observational study following outcomes of upper airway stimulation (UAS) therapy in patients who have failed continuous positive airway pressure therapy for obstructive sleep apnea (OSA). The aim of this registry and purpose of this article were to examine the outcomes of patients receiving UAS for treatment of OSA.Study Design: Cohort Study.Methods: Demographic and sleep study data collection occurred at baseline, implantation visit, post-titration (6 months), and final visit (12 months). Patient and physician reported outcomes were also collected. Post hoc univariate and multivariate analysis was used to identify predictors of therapy response, defined as ≥50% decrease in Apnea-Hypopnea Index (AHI) and AHI ≤20 at the 12-month visit.Results: The registry has enrolled 1,017 patients from October 2016 through February 2019. Thus far, 640 patients have completed their 6-month follow-up and 382 have completed the 12-month follow-up. After 12 months, median AHI was reduced from 32.8 (interquartile range [IQR], 23.6-45.0) to 9.5 (IQR, 4.0-18.5); mean, 35.8 AE 15.4 to 14.2 AE 15.0, P < .0001. Epworth Sleepiness Scale was similarly improved from 11.0 (IQR, 7-16) to 7.0 (IQR, 4-11); mean, 11.4 AE 5.6 to 7.2 AE 4.8, P < .0001. Therapy usage was 5.6 AE 2.1 hours per night after 12 months. In a multivariate model, only female sex and lower baseline body mass index remained as significant predictors of therapy response.Conclusions: Across a multi-institutional study, UAS therapy continues to show significant improvement in subjective and objective OSA outcomes. This analysis shows that the therapy effect is durable and adherence is high.

Changes in breath cycle sensing affect outcomes in upper airway stimulation in sleep apnea

“…Patient's characteristics with regard to middle age, male gender, and moderate to severe OSA were in correspondence with previous reports in larger cohorts . Therapy usage was high at initial assessment but did not differ from other UAS publications .…”

“…Most previous reports on patient reported outcomes document changes in time points with larger intervals . Thus, intervention periods that were too short could be the reasons for the mismatch of unchanged ESS and documented sleep architecture …”

“…Hypoglossal nerve stimulation with respiratory sensing (upper airway stimulation [UAS]) has gained increasing interest for the treatment of patients with obstructive sleep apnea (OSA) and positive airway pressure failure. To achieve success rates of about 70% and intensive usage, appropriate candidate selection and precise identification of the branches of the hypoglossal nerve are needed . The electric field—arising from the different modes of electrode configuration in the implant—influences the patient's tongue motion patterns, which are regarded to be a predictor of response to therapy …”

<p>Hypoglossal Nerve Stimulation in the Treatment of Obstructive Sleep Apnea: Patient Selection and New Perspectives</p>

“…On the contrary, the Adhere Registry study highlighted a 8.5% reduced odds of treatment success for each unit increase in BMI. 28 Although further data are needed to clarify this incongruence, it seems that BMI > 32 Kg/m 2 represents only an indirect predictor of HNS response. 36 The positive correlation between BMI and the probability of complete concentric palatal collapse has been described.…”

“…The STAR trial 26 used an AHI between 20 and 50 events per hour as an important inclusion criteria. Both the German Postmarket study 27 and the Adhere Registry 28 showed that OSA severity measured by baseline AHI is not a predictor of therapy response. If Sher criteria 29 (50% reduction in AHI and overall AHI < 20) is used to define treatment response, an elevated AHI (more than 65) is not a HNS contraindication considering the reported treatment success in several studies, leading to a potential benefit for some patients with particularly severe disease.…”