Three-Year Outcomes of Proximal Hypoglossal Nerve Stimulation in OSA.

Abstract

Targeted proximal hypoglossal nerve stimulation (THN, pHGNS) improved sleep-disordered breathing, sleep architecture, and quality of life (QOL) with a favorable safety profile over 1 year in the THN3 randomized, controlled trial. Herein, THN3 pHGNS 3-year safety and efficacy are profiled with reference to distal HGNS (dHGNS) from the STAR trial. What are the long-term safety and efficacy of pHGNS, and how do they compare to dHGNS? THN3 enrollees had an apnea-hypopnea index (AHI) 20-65/hr and body mass index (BMI) ≤ 35 kg/m². Participants completing the pre-specified 3-year visit were analyzed. Outcomes included adverse events, AHI, oxygen desaturation index (ODI), percentage of sleep time with oxygen saturation <90% (T90) and QOL. pHGNS responses at 24 and 36 months were compared with baseline and 11 months of therapy (Months 12/15). pHGNS and dHGNS results were compared through 36 months. One hundred four of 138 (75%) of THN3 participants completed 3-year follow-up. pHGNS delivered sustained improvements in sleep-disordered breathing, oxygenation, and QOL at months 24 and 36 vs baseline. Long-term outcomes were comparable to those at 11 months of treatment: median AHI reductions were -15.1/h (95%CI, -18.6, -12.6) and -17.7/h (-21.9, -15.3) with large effect sizes: probabilities of superiority vs baseline were .79 (.72-.87) and .79 (.70-.87), respectively. Benefits in sleep disordered breathing and QOL were sustained at 36 months and appeared to be comparable to those reported for dHGNS at 3 years. Therapeutic responses to pHGNS at 1 year were maintained through 3 years with relatively few adverse events. Similarities in responses to dHGNS suggest that pHGNS provides safe and effective long-term OSA treatment. ClinicalTrials.gov; No.: NCT02263859; URL: www. gov.