Abstract
STUDY OBJECTIVES: Data on adherence and outcome of upper airway stimulation (UAS) for patients with obstructive sleep apnea (OSA) are collected in an international registry (ADHERE). Previous publications report significant improvement in self-reported and objective OSA outcomes, durable effectiveness, and high adherence. Debate remains whether the effectiveness of UAS is influenced by preoperative OSA severity; therefore, we aimed to evaluate this using data from the ADHERE Registry. METHODS: ADHERE is a postmarket, ongoing, international multicenter registry. Adult patients were included if they had undergone UAS implantation and had at least 1 follow-up visit recorded in the database on June 8, 2021. We divided the patients into 5 subgroups, based on OSA severity at baseline (AHI in events/h): subgroup 1 (0-15), 2 (15-30), 3 (≥ 30-50), 4 (> 50-65), and 5 (> 65). We compared results regarding objective and self-reported treatment outcomes. RESULTS: A total of 1,963 patients were included. Twelve months after implantation, there was a significant (P < .0001) improvement in objective sleep parameters in all subgroups with an AHI above 15 events/h. Patients in subgroup 1 had the lowest AHI at the final visit and the AHI reduction in patients in subgroup 5 was the largest (P < .0001). No significant difference was found between the subgroups in overall treatment success (66.6%) and improvement in self-reported outcomes. CONCLUSIONS: Our results suggest that UAS is an effective treatment for patients with an AHI ≥ 15 events/h, independent of preoperative OSA severity. Self-reported outcomes and treatment success did not differ significantly between the 5 subgroups. These results clearly support that the indication of UAS could be broadened for patients with an AHI above 65 events/h, which, to date, is not common practice. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry (ADHERE Registry); Identifier: NCT02907398; URL: https://www.clinicaltrials.gov/ct2/show/NCT02907398. CITATION: Bosschieter PFN, de Vries N, Mehra R, et al. Similar effect of hypoglossal nerve stimulation for obstructive sleep apnea in 5 disease severity categories. J Clin Sleep Med. 2022;18(6):1657-1665.
| Original language | English |
|---|---|
| Pages (from-to) | 1657-1665 |
| Number of pages | 9 |
| Journal | Journal of clinical sleep medicine |
| Volume | 18 |
| Issue number | 6 |
| Early online date | 1 Jun 2022 |
| DOIs | |
| Publication status | Published - Jun 2022 |
Bibliographical note
Publisher Copyright:© 2022 American Academy of Sleep Medicine.
Funding
All authors have seen and approved the manuscript. The ADHERE Registry is sponsored by Inspire Medical Systems, Inc (Minneapolis, MN). The ADHERE Registry is a real-world registry that collects data on all individuals who were implanted with the Inspire UAS System and have consented to having their data collected; this includes patients who were implanted outside of labeling (including patients with an apnea-hypopnea index > 65 events/h, etc). Prof. Dr. O. Vander-veken reports research grants from Philips and Somnomed at Antwerp University Hospital, research support from Inspire Medical Systems and Nyxoah at Antwerp University Hospital, and a Senior Clinical Fellowship Grant (Fundamenteel Klinisch Mandaat) from Research Foundation–Flanders–Vlaanderen (FWO). Prof. Dr. S. Manchanda is consultant on the Physician Advisory Council for Inspire Medical Systems. Prof. Dr. N. de Vries is a member of the Medical Advisory Board of NightBa-lance and a consultant for Philips Healthcare, Inspire Medical Systems, and Nyxoah. The other authors report no conflicts of interest.
| Funders | Funder number |
|---|---|
| Research Foundation–Flanders–Vlaanderen | |
| Fonds Wetenschappelijk Onderzoek | |
| Universitair Ziekenhuis Antwerpen |
Keywords
- obstructive
- sleep apnea
- therapy