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Published on: December 6, 2016
Three-Year Outcomes of Proximal Hypoglossal Nerve Stimulation in OSA
Alan R Schwartz1, Ofer Jacobowitz2, Samuel A Mickelson3
1Department of Otorhinolaryngology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Department of Otolaryngology, Vanderbilt University School of Medicine, Nashville, TN.
Background:
Targeted proximal hypoglossal nerve stimulation was shown to improve sleep-disordered breathing, sleep architecture, and quality of life (QOL) with a favorable safety profile over 1 year in the Targeted Hypoglossal Stimulation 3 (THN3) randomized controlled trial. Herein, THN3 proximal hypoglossal nerve stimulation (pHGNS) 3-year safety and efficacy are profiled with reference to distal hypoglossal nerve stimulation (dHGNS) from the Stimulation Therapy for Apnea Reduction (STAR) trial.
Research Question:
What are the long-term safety and efficacy of pHGNS, and how do they compare with dHGNS?
Study Design And Methods:
THN3 (NCT02263859) enrollees had an apnea-hypopnea index (AHI) 20-65/hr and BMI ≤ 35 kg/m2. Participants completing the prespecified 3-year visit were analyzed. Outcomes included adverse events, AHI, Oxygen Desaturation Index, percentage of sleep time with oxygen saturation <90%, 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.
Results:
One hundred four of 138 (75%) 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 0.79 (0.72-.87) and 0.79 (0.70-.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.
Interpretation:
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 efficacious long-term OSA treatment.
Clinical Trial Registration:
ClinicalTrials.gov; No.: NCT02263859; URL: www.
Clinicaltrials:
gov.
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