aLiberty University College of Osteopathic Medicine, Lynchburg, Virginia
bWalter Reed Army Institute of Research, Silver Spring, Maryland
cUniformed Services University of the Health Sciences, Bethesda, Maryland
Author disclosures
The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.
Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.
The TJU and UP cohorts are composed of patients who underwent implantation between May 2014 and August 2016 at 2 academic centers.31,32 Selection criteria was consistent with that used in the STAR trial, and patients completed postoperative titration PSG and outpatient follow-up (48 patients at TJU and 49 at UP). Primary outcomes included AHI, ESS, and O2 nadir. Secondary outcomes consisted of surgical success and percentage of patients tolerating optimal titration setting at follow-up. Postoperative outcomes were assessed during the titration PSG. Time from initial ESS to postoperative PSG at TJU was 1.7 years and at UP was 1.9 years. Time from initial AHI to postoperative PSG at TJU was 90.4 days and 85.2 days at UP. At TJU, mean (SD) AHI and ESS dropped from 35.9 (20.8) and 11.1 (3.8), respectively at baseline to 6.3 (11.5) and 5.8 (3.4), respectively at follow-up. At UP, mean (SD) AHI and ESS fell from 35.3 (15.3) and 10.9 (4.9), respectively at baseline to 6.3 (6.1) and 6.6 (4.5), respectively at follow-up. There were no site-related differences in rates of AHI, ESS, or surgical success.31
Pordzik and Colleagues Cohort
This cohort of 29 patients underwent implantation between February 2020 and June 2022 at a tertiary university medical center with both pre- and postoperative PSG. Selection criteria was consistent with that of the German postmarket cohort. Postoperative PSG was completed a mean (SD) 96.3 (27.0) days after device activation. Mean (SD) AHI dropped from 38.6 (12.7) preoperatively to 24.4 (13.3) postoperatively. Notably, this cohort showed a much lower decrease of postoperative AHI than reported by the STAR trial and UP/TJU cohort.33
Stimulation vs Sham Trial
This multicenter, double-blinded, randomized, crossover trial assessed the effect of HGNS (stim) vs sham stimulation (sham) in 86 patients that completed both phases of the trial. Primary outcomes included AHI and ESS. Secondary outcomes included FOSQ. No carryover effect was found during the crossover phase. The difference between the phases was−15.5 (95% CI, −18.3 to −12.8) for AHI and −3.3 (95% CI, −4.4 to −2.2) for ESS.34
Comparator
The comparator study used propensity score matching to compare outcomes of HGNS and PAP therapy. Primary outcomes included sleepiness, AHI, and effectiveness with outcome measures of AHI and ESS collected at baseline and 12 months postimplantation. The article reported that 126 of 227 patients were matched 1:1. Both groups showed improvement in AHI and ESS. Mean (SD) AHI for the HGNS group at baseline started at 33.9 (15.1) and decreased to 8.1 (6.3). Mean (SD) ESS for the HGNS group at baseline was 15.4 (3.5) and decreased to 7.5 (4.7). In the PAP comparator group, mean (SD) baseline AHI was 36.8 (21.6) and at follow-up was 6.6 (8.0) and mean (SD) ESS was 14.6 (3.9) at baseline and 10.8 (5.6) at follow-up.35
DISCUSSION
The current clinical data on HGNS suggest that this treatment is effective in adults with moderate-to-severe OSA and effects are sustained at long-term follow-up, as measured by AHI reduction and improvements in sleep related symptoms and quality of life (Table 2). These results have been consistent across several sites.
The STAR trial included a randomized control withdrawal group, for whom HGNS treatment was withdrawn after the 12-month follow-up, and then restored at 18 months.21 This revealed that withdrawal of HGNS treatment resulted in deterioration of both objective and subjective measures of OSA and sleepiness. The beneficial effects of HGNS were restored when treatment was resumed.24 Additionally, the RCCT revealed that therapeutic stimulation via HGNS significantly reduced subjective and objective measures of OSA.34 These studies provide definitive evidence of HGNS efficacy.
Currently, a diagnosis of OSA on PAP is classified as a 50% military disability rating. This rating is based primarily on epidemiologic evidence that untreated OSA is a costly disease that leads to other chronic illnesses that increases health care utilization.9 HGNS requires an initially invasive procedure and higher upfront costs, but it could result in reduced health care use and long-term costs because of improved adherence to treatment—compared with CPAP—that results in better outcomes.
