0785 Cardiovascular Outcomes For Obstructive Sleep Apnea With HGNS Therapy

Abstract

Introduction Obstructive sleep apnea (OSA) is linked to cardiovascular disease, particularly when left untreated. Hypoglossal nerve stimulation (HGNS) is a novel and promising PAP alternative as it is well-tolerated and reduces OSA severity; however, its effect on mitigating cardiovascular risk secondary to OSA is unknown. The aim of this study is to evaluate the effect of HGNS on sympathetic and vascular function. Our hypothesis is mean 24-hour systolic blood pressures (SBP) will be improved at “active” levels of HGNS. Methods This study is a double-blinded, sham-controlled, randomized controlled therapy crossover trial. Subjects are randomized for four weeks in each arm to either “active” HGNS or “sham” HGNS, with “sham” HGNS being defined as the lowest voltage at which HGNS was sensed by the patient and/or visualized by the principal investigator. Included patients had already been implanted with the Inspire® device. Patients were excluded for active PAP therapy use, recent automobile accidents, a minimum difference (<30%) between “active” and “sham” voltages, and pregnancy. Results 53 patients met all inclusion criteria. Overall, the study cohort was older (mean [SD] age 66.8 [10.2]), overweight (BMI 28.8 [4.36]), 60% male, and predominantly of white race. There was no significant difference in mean 24-hour SBP between “active” and “sham” HGNS (122.4 mmHg [12.2] vs. 122.4 mmHg [11.2], respectively). Further, there was no significant difference in mean SBP during sleep between “active” and “sham” HGNS (115.0 mmHg [15.2] vs. 115.2 mmHg [14.4], respectively). Conclusion This is a randomized controlled trial evaluating cardiovascular outcomes in patients with OSA using HGNS therapy. The HGNS system permits a unique investigation of the therapy “on/off” effect on measures of the sympathetic nervous system and vascular health. “Active” HGNS levels, compared to “sham” HGNS levels, do not appear to reduce mean systolic blood pressure during wake or sleep periods. Support (If Any) Raj C. Dedhia, MD, MSCR is supported by the American Heart Association and the American Sleep Medicine Foundation.