Similar effect of hypoglossal nerve stimulation for obstructive sleep apnea in 5 disease severity categories

Pien F N Bosschieter; Nico de Vries; Reena Mehra; Shalini Manchanda; Tapan A Padhya; Olivier M Vanderveken; M J L Ravesloot; ADHERE Registry Investigators

doi:10.5664/jcsm.9956

Similar effect of hypoglossal nerve stimulation for obstructive sleep apnea in 5 disease severity categories

J Clin Sleep Med. 2022 Jun 1;18(6):1657-1665. doi: 10.5664/jcsm.9956.

Authors

Pien F N Bosschieter¹, Nico de Vries^{1

2

3

4}, Reena Mehra⁵, Shalini Manchanda⁶, Tapan A Padhya⁷, Olivier M Vanderveken^{3

4}, M J L Ravesloot¹; ADHERE Registry Investigators

Affiliations

¹ Department of Otorhinolaryngology-Head and Neck surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
² Department of Oral Kinesiology, Academisch Centrum Tandheelkunde Amsterdam MOVE Research Institute Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, The Netherlands.
³ Department of Otorhinolaryngology-Head and Neck Surgery Antwerp University Hospital (UZA), Antwerp, Belgium.
⁴ Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
⁵ Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio.
⁶ Division of Pulmonary, Critical Care, Sleep, and Occupational Medicine, Indiana University School of Medicine, Indianapolis, Indiana.
⁷ Department of Otolaryngology-Head and Neck Surgery, University of South Florida Morsani College of Medicine, Tampa, Florida.

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.

Keywords: obstructive; sleep apnea; therapy.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Electric Stimulation Therapy* / methods
Humans
Hypoglossal Nerve
Severity of Illness Index
Sleep Apnea, Obstructive* / therapy
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT02907398