0578 PREDICTORS OF SUCCESS FOR OSA TARGETED HYPOGLOSSAL NEUROSTIMULATION

Abstract

Introduction: Targeted Hypoglossal Neurostimulation (THN) is a novel treatment for OSA that aims to stimulate selective tongue muscles using a 6-contact cuff, placed around the hypoglossal nerve trunk. Selective stimulation and cycling between contacts is used to minimize risk of neuromuscular fatigue. From earlier safety and feasibility trials, predictors of success (POS) criteria were retrospectively identified based on BMI, AHI, AHI and oxygen desaturation parameters. These POS criteria are currently utilized in the THN3 pivotal trial. In this study we validated the POS criteria in a cohort of patients implanted outside of trial in multiple centers internationally. Methods: Thirty patients with moderate to severe OSA were implanted with ImThera Medical's aura6000 THN Sleep TherapyTM System from 2013-2016. Preoperative sleep testing consisted of either attended polysomnographic or home testing. Stimulation parameters were set during polysomnography at 1 month post implantation with subsequent therapy initiation. AHI outcome was assessed using sleep testing at 3-6 months, and at 12 months and analyzed against the POS criteria. Predictors criteria included BMI< 35 kg/M2, AI< 30, AHI< 65 and < 15 oxygen desaturations/ hour of >10%. Patients were classified as responders if they demonstrated a reduction in AHI of at least 50% and an AHI < 20. Results: At baseline, the mean Body Mass Index (BMI) was 27.3 (range 21.0-35.4), Apnea Hypopnea Index (AHI) was 50.0 (range 25-106), and Oxygen Desaturation Index (ODI) was 47.8 (range 4.6- 83.0). Outcome data was available for 18 patients. Mean AHI decreased from 50.0+/-21.9 to 19.3 +/-16.0 at 3-6 months and to 17.8+/-15.6 at 12 months (p