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 ± 15.4 to 14.2 ± 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 ± 5.6 to 7.2 ± 4.8, P < .0001. Therapy usage was 5.6 ± 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.

Level of evidence: 2 Laryngoscope, 130:1333-1338, 2020.

Keywords: Obstructive sleep apnea; drug-induced sleep endoscopy; surgery; upper airway stimulation.

Figure 1

Approach to the anterior branches of the hypoglossal nerve. The first step is to identify and retract the posterior edge of the anterior belly of the digastric muscle (black arrow). The second step is to identify and anteriorly retract the posterior edge of the mylohyoid muscle. Just underneath this and at the anterior border of the submandibular gland is the hypoglossal nerve as it begins to branch. Genioglossus branches are identified with nerve stimulation and a neuromonitor.

Figure 2

Median AHI measurements at baseline and at 6 and 12 months postoperatively. Error bars in SD. AHI = Apnea‐Hypopnea Index; SD = standard deviation.

Figure 3

ESS measurements at baseline and at 6 and 12 months postoperatively. Error bars in SD. ESS = Epworth Sleepiness Scale; SD = standard deviation.