0453 3-Year Outcomes of Proximal Hypoglossal Nerve Stimulation in the THN3 Controlled Trial

Abstract Introduction The THN3 randomized, controlled trial of moderate to severe obstructive sleep apnea (OSA) showed that proximal (“targeted”) hypoglossal nerve stimulation (HGNS) safely improved sleep-disordered breathing (SDB) and quality life (QOL) through 11 months treatment. Outcomes subjects receiving active HGNS also surpassed those with inactive therapy 4 post-implant. Herein 3-year outcomes are reported compared distal (STAR trial). Methods OSA (Apnea-Hypopnea Index, AHI, 20-65/hr; BMI ≤ 35 kg/m2, no drug-induced endoscopy screening) were followed long-term. Complete data follow-up analyzed. Efficacy measures comprised Oxygen Desaturation Index (ODI), %sleep time O2 saturation < 90% (T90), Epworth Sleepiness Scale (ESS), Functional Sleep Questionnaire (FOSQ) EQ-5D Visual Analog (VAS) Snore Survey (SOS). 36-Month medians against after (Month 12/15) STAR. Adverse events (AEs) during Months 12-36 for STAR compared. Results 75% participants (104/138) attended follow-up, complete efficacy records in N≥93 except SOS (N=67, not administered at all sites). Proximal produced clinically statistically significant improvements SDB QOL Month 12/15 closely maintained 36 (median paired changes from Baseline/Month 12/15: □AHI:-18.2/-0.1, □ODI:-16.2/0.8, □T90:-1.8/0.2, □FOSQ:3.0/0.0, □ESS:-5.0/0.0, □VAS:5.0/0.0, □SOS:37.5/3.1) comparable (□AHI:-19.4, □ODI:-17.2, □T90:-1.5, □FOSQ: 2.6, □ESS:-4.0). Procedure- device-related AEs respectively totaled (3 27)/(4 122) THN3/STAR over 12-36. During this time, 3 related-AEs occurred THN3; the most frequent related involved tongue discomfort (N=8, device-related). Conclusion Improvements on persisted least 36. long-term was HGNS. uncommonly typically mild. is a safe, effective, stable, therapy, yielding treating OSA. ongoing, confirmatory OSPREY randomized will provide additional insights into therapeutic benefits Support (if any) LivaNova