Impact of Body Mass Index and Discomfort on Upper Airway Stimulation: ADHERE Registry 2020 Update

ADHERE Registry Investigators

Research output: Contribution to JournalArticleAcademicpeer-review

Abstract

© 2021 The American Laryngological, Rhinological and Otological Society, Inc.Objectives/Hypothesis: To provide the ADHERE registry Upper Airway Stimulation (UAS) outcomes update, including analyses grouped by body mass index (BMI) and therapy discomfort. Study Design: Prospective observational study. Methods: ADHERE captures UAS outcomes including apnea-hypopnea index (AHI), Epworth sleepiness scale (ESS), therapy usage, patient satisfaction, clinician assessment, and safety over a 1-year period. BMI ≤32 kg/m2 (BMI32) and 32 < BMI ≤35 kg/m2 (BMI35) group outcomes were examined. Results: One thousand eight hundred forty-nine patients enrolled in ADHERE, 1,019 reached final visit, 843 completed the visit. Significant changes in AHI (−20.9, P <.0001) and ESS (− 4.4, P <.0001) were demonstrated. Mean therapy usage was 5.6 ± 2.2 hr/day. Significant therapy use difference was present in patients with reported discomfort versus no discomfort (4.9 ± 2.5 vs. 5.7 ± 2.1 hr/day, P =.01). Patients with discomfort had higher final visit mean AHI versus without discomfort (18.9 ± 18.5 vs. 13.5 ± 13.7 events/hr, P =.01). Changes in AHI and ESS were not significantly different. Serious adverse events reported in 2.3% of patients. Device revision rate was 1.9%. Surgical success was less likely in BMI35 versus BMI32 patients (59.8% vs. 72.2%, P =.02). There was a significant therapy use difference: 5.8 ± 2.0 hr/day in BMI32 versus 5.2 ± 2.2 hr/day in BMI35 (P =.028). Conclusions: Data from ADHERE demonstrate high efficacy rates for UAS. Although surgical response rate differs between BMI32 and BMI35 patient groups, the AHI and ESS reduction is similar. Discomfort affects therapy adherence and efficacy. Thus, proper therapy settings adjustment to ensure comfort is imperative to improve outcomes. Level of Evidence: 4 Laryngoscope, 131:2616–2624, 2021.
Original languageEnglish
Pages (from-to)2616-2624
JournalLaryngoscope
Volume131
Issue number11
DOIs
Publication statusPublished - 1 Nov 2021

Funding

m.v.s. has received honoraria from Inspire Medical; a.s. has received honoraria and covered travel expenses for invited talks on behalf of Inspire Medical; m.b. has received research support and is a consultant for Inspire Medical; r.d.p. has received honoraria from Inspire Medical; c.h. has received research grant, travel support and consulting honoraria from Inspire Medical; c.h. has received research support from Inspire Medical; c.l. is a consultant for Inspire Medical; j.t.m. received honoraria from ImThera Medical, is a consultant and received honoraria from Inspire Medical, is a consultant and received honoraria from Nyxoah Medical, has received honoraria and travel reimbursement from Neuwirth Medical Products; r.s. received research support from Inspire Medical, consultant for Smith & Nephew, Cryosa Inc, Invicta Medical, Inspire Medical, Galvani Bioelectronics, Enhale Medical; n.d.v. is a researcher for Inspire, Nyxoah, on medical advisory board for Philips NightBalance; h.w. serves as the principal investigator of the studies with Inspire at Cleveland Clinic, has received funding from Resmed; e.t. has received a research grant from Inspire Medical. The study is financially supported by Inspire Medical Systems.

FundersFunder number
ImThera Medical
Inspire Medical Systems
Inspiro Medical

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