Abstract
Abstract Introduction Upper Airway Stimulation is an approved technology for the treatment of moderate to severe obstructive sleep apnea. Differences exist among specific indications for use and/or coverage limits, with certain geographies supporting a broader AHI range (15-65 events/hr) compared to others that are limited to a narrower range (AHI 20-50 events/hr). This study provides a comparison of the outcomes related to these two groups. Methods This is a retrospective analysis of two data sets: (1) STAR pivotal data set, including only patients with a baseline AHI (average of pre-implant and post-implant/pre-activation AHIs) between 20 - 50 event/hr; compared to (2) ADHERE Registry data set, including only patients with a baseline AHI (pre-implant) between 15 -65 events/hr. Baseline demographics, as well as AHI and Epworth Sleepiness Scale (ESS) at 12 months post-implant, were compared between the two groups. Results A total of 94 STAR subjects (AHI 20-50) were compared to 1604 ADHERE subjects (AHI 15-65; with AHI 15-20 in 192 subjects and AHI 50-65 in 208 subjects). The STAR group had a significantly lower age (54.6±10.2 vs 60.2±10.9, p< 0.001), lower baseline AHI (31.8±7.6 vs 34.7±12.6, p< 0.001) and more males (85.1% vs 75.5%, p=0.03) compared to the ADHERE group. At 12-months post-implant, there were no significant differences in AHI (15.2±15.5 vs 15.7±14.7, p=0.33), change in AHI from baseline (16.5±14.7 vs 18.5±20.3, p=0.23), Sher Responder Rate (67.7% vs 63.4%, p=0.47) or ESS (7.0±4.2 vs 6.9±4.6, p=0.53) between the STAR and ADHERE groups. Conclusion While subjects implanted under the narrower AHI range (20-50 events/hr) were younger and had a significantly lower AHI at baseline, results in these patients were comparable to patients implanted under the broader range of AHI 15-65. Support (if any) The STAR study and ADHERE Registry were sponsored by Inspire Medical Systems, Inc.
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