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

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.

Early feasibility of hypoglossal nerve upper airway stimulator in patients with cardiac implantable electronic devices and continuous positive airway pressure-intolerant severe obstructive sleep apnea.

BACKGROUND: Implantable hypoglossal nerve upper airway stimulation (HNS) is a novel strategy approved by the US Food and Drug Administration for the management of moderate-to-severe obstructive sleep apnea (OSA) in patients with continuous positive airway pressure therapy intolerance or failure. Because of the proximity of a cardiac implantable electronic device (CIED) to this stimulator, interaction between these devices is theoretically possible. OBJECTIVE: The purpose of this study was to assess interactions between an implantable HNS device and a CIED. METHODS: We retrospectively analyzed 14 ad hoc patients with continuous positive airway pressure-intolerant, moderate-to-severe OSA and pre-existing transvenous CIEDs undergoing HNS implantation (Inspire II, Inspire Medical Systems). We assessed these devices for their pre and postimplant OSA outcomes and for possible device-device interaction. All patients were followed up for 1 year. RESULTS: Of the 14 patients, 9 had a pacemaker (8 dual-chamber, 1 single-chamber), 4 had an implantable cardioverter-defibrillator (2 dual-chamber, 1 single-chamber), and 1 had a cardiac resynchronization therapy device. All the HNS devices were implanted on the opposite side of the CIED. All CIEDs were programmed bipolar. HNS were programmed either unipolar or bipolar. During implant, intraoperative testing was performed to confirm that bipolar and unipolar HNS stimulation did not impact CIED sensing. During the follow-up period, no oversensing episodes were noted on the CIEDs. CONCLUSION: In this early experience, simultaneous use of a novel hypoglossal nerve upper airway stimulation device with transvenous CIEDs seems to be safe, effective, and without any device-device interactions.