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

Maria V Suurna, Armin Steffen, Maurits Boon, Eugene Chio, Marcel Copper, Reena Dhanda Patil, Katherine Green, Ronald Hanson, Clemens Heiser, Colin Huntley, David Kent, Christopher Larsen, Shalini Manchanda, Joachim T Maurer, Ryan Soose, Nico de Vries, Harneet K Walia, Erica Thaler

Journal: The Laryngoscope 2021;131(11):2616-2624

PMID: 34626128

Full Text on Wiley View on PubMed

Abstract

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/m (BMI ) and 32 < BMI ≤35 kg/m (BMI ) 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 BMI versus BMI patients (59.8% vs. 72.2%, P = .02). There was a significant therapy use difference: 5.8 ± 2.0 hr/day in BMI versus 5.2 ± 2.2 hr/day in BMI (P = .028).

CONCLUSIONS

Data from ADHERE demonstrate high efficacy rates for UAS. Although surgical response rate differs between BMI and BMI 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.

Address: Department of Otolaryngology-Head and Neck Surgery, Weill Cornell Medicine/New York Presbyterian Hospital, New York, New York, U.S.A.; Department of Otorhinolaryngology, University of Lübeck, Lübeck, Germany.; Department of Otolaryngology - Head and Neck Surgery, Thomas Jefferson University Hospital.; Department of Otolaryngology - Head and Neck Surgery, Ohio State University, Columbus, Ohio, U.S.A.; Department of Otolaryngology-Head and Neck Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.; Department of Otolaryngology - Head and Neck Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio, U.S.A.; Department of Surgical Services, Cincinnati Veterans Affairs Medical Center, Cincinnati, Ohio, U.S.A.; Department of Otolaryngology, University of Colorado, Denver, Colorado, U.S.A.; Otolaryngology, St. Cloud Ear, Nose, Throat Clinic, St. Cloud, Minnesota, U.S.A.; Department of Otorhinolaryngology, Head and Neck Surgery, Technische Universität München, Munich, Germany.; Department of Otolaryngology, Vanderbilt University Medical Center, Nashville, Tennessee, U.S.A.; Department of Otolaryngology-Head and Neck Surgery, Kansas University Medical Center, Andover, Kansas, U.S.A.; Section of Pulmonary, Critical Care, Sleep and Occupational Medicine, Indiana University School of Medicine and Indiana University Health, Indianapolis, Indiana, U.S.A.; Division of Sleep Medicine, Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.; Division of Sleep Surgery, Department of Otolaryngology, Pittsburgh School of Medicine, UPMC Mercy, University of Pittsburgh, Pittsburgh, Pennsylvania, U.S.A.; Department of Ear, Nose and Throat, OLVG, Department of Oral Kinesiology, ACTA Amsterdam, Amsterdam, The Netherlands.; Cleveland Clinic, Sleep Disorders Center, Neurological Institute, Cleveland, Ohio, U.S.A.; Center for Sleep and Circadian Neurobiology, University of Pennsylvania, Philadelphia, Pennsylvania, U.S.A.

DOI: 10.1002/lary.29755

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https://doi.org/10.1002/lary.29755

MeSH Terms: Aged, Body Mass Index, Electric Stimulation Therapy, Female, Humans, Implantable Neurostimulators, Male, Middle Aged, Patient Compliance, Prospective Studies, Registries, Severity of Illness Index, Sleep Apnea, Obstructive, Treatment Outcome