Bilateral vs Unilateral Hypoglossal Nerve Stimulation in Patients With Obstructive Sleep Apnea

• Published in: OTO open : the official open access journal of the American Academy of Otolaryngology--Head and Neck Surgery Foundation Vol. 6; no. 3; pp. 2473974X221109794 - n/a
• Main Authors: Heiser, Clemens, Sommer, J. Ulrich, Hofauer, Benedikt, de Vries, Nico, Ravesloot, Madeline JL, Vanderveken, Olivier M., Jira, Daniel
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.07.2022; John Wiley & Sons, Inc; Wiley
• Subjects: bilateral hypoglossal nerve stimulation; Clinical outcomes; Electric stimulation therapy; hypoglossal nerve stimulation; Nervous system; neurostimulation; obstructive sleep apnea; Original Research; Oxygen saturation; Sleep apnea; upper airway stimulation; obstructive sleep apnea; bilateral hypoglossal nerve stimulation; hypoglossal nerve stimulation; upper airway stimulation; neurostimulation
• ISSN: 2473-974X; 2473-974X
• DOI: 10.1177/2473974X221109794

Objective Unilateral hypoglossal nerve stimulation (uniHNS) is an effective treatment for obstructive sleep apnea. Bilateral hypoglossal nerve stimulation (biHNS) is a novel therapeutic option and a different approach to hypoglossal nerve stimulation. The aim of this study was to analyze the clinical outcome of the first 10 biHNS cases vs the first 10 uniHNS cases ever implanted. Study Design Prospective data analysis. Setting International multicenter comparative clinical trial. Methods The first 10 patients in 2020 who received a biHNS device (Genio System; Nyxoah) and the first 10 patients in 2014 who received a uniHNS system (Inspire II; Inspire Medical Systems) were included. Treatment outcome was evaluated at 3 months after surgery. Data collection included demographics, apnea hypopnea index (AHI), oxygen saturation and desaturation index, Epworth Sleepiness Scale, and adverse events. Results The mean ± SD age was 52.1 ± 9.6 years (biHNS) and 58.3 ± 8.6 years (uniHNS). The mean body mass index was 26.4 ± 5.6 kg/m2 (biHNS) and 26.2 ± 2.2 kg/m2 (uniHNS). The mean preimplantation AHI (biHNS, 39.9 ± 14.8/h; uniHNS, 32.2 ± 11.0/h) decreased in both groups after 3 months (biHNS, 19.2 ± 14.0/h, P = .008; uniHNS, 13.1 ± 16.8/h, P = .037) with no significant difference between groups (P = .720). The mean preimplantation Epworth Sleepiness Scale (biHNS, 11.8 ± 6.2; uniHNS, 11.1 ± 4.9) decreased as well after 3 months (biHNS, 9.4 ± 6.3; uniHNS, 6.0 ± 5.0). Conclusion Preliminary postmarket data suggest that biHNS may be as safe and effective as uniHNS. Long-term follow-up in a larger sample size is required to assess the stability of biHNS.