Results of the ADHERE upper airway stimulation registry and predictors of therapy efficacy

  • Erica Thaler
    Department of Otorhinolaryngology–Head and Neck Surgery University of Pennsylvania Philadelphia Pennsylvania
  • Richard Schwab
    Penn Sleep Center, University of Pennsylvania Philadelphia Pennsylvania
  • Joachim Maurer
    Sleep Disorders Center, University Hospital Mannheim Mannheim Germany
  • Ryan Soose
    Department of Otolaryngology University of Pittsburgh Pittsburgh Pennsylvania
  • Christopher Larsen
    Department of Otolaryngology–Head and Neck Surgery University of Kansas Medical Center Kansas City Kansas
  • Suzanne Stevens
    Department of Otolaryngology–Head and Neck Surgery University of Kansas Medical Center Kansas City Kansas
  • Damien Stevens
    Department of Otolaryngology–Head and Neck Surgery University of Kansas Medical Center Kansas City Kansas
  • Maurits Boon
    Department of Otolaryngology–Head and Neck Surgery Thomas Jefferson University Hospitals Philadelphia Pennsylvania
  • Colin Huntley
    Department of Otolaryngology–Head and Neck Surgery Thomas Jefferson University Hospitals Philadelphia Pennsylvania
  • Karl Doghramji
    Department of Otolaryngology–Head and Neck Surgery Thomas Jefferson University Hospitals Philadelphia Pennsylvania
  • Tina Waters
    Cleveland Clinic Health System Cleveland Clinic Cleveland Ohio
  • Alan Kominsky
    Head and Neck Institute Cleveland Clinic Cleveland Ohio
  • Armin Steffen
    Department of Otorhinolaryngology University of Lübeck Lübeck Germany
  • Eric Kezirian
    Department of Otolaryngology–Head and Neck Surgery Keck School of Medicine at University of Southern California Los Angeles California
  • Benedikt Hofauer
    Department of Otorhinolaryngology–Head and Neck Surgery Klinikum rechts der Isar, Technical University Munich Munich Germany
  • Ulrich Sommer
    Department of Otorhinolaryngology–Head and Neck Surgery University Hospital Mannheim Mannheim Germany
  • Kirk Withrow
    Department of Otolaryngology University of Alabama School of Medicine Birmingham Alabama
  • Kingman Strohl
    Department of Medicine Case Western Reserve University Cleveland Ohio U.S.A
  • Clemens Heiser
    Department of Otorhinolaryngology–Head and Neck Surgery Klinikum rechts der Isar, Technical University Munich Munich Germany

抄録

<jats:sec><jats:title>Objective/Hypothesis</jats:title><jats:p>The ADHERE Registry is a multicenter prospective observational study following outcomes of upper airway stimulation (UAS) therapy in patients who have failed continuous positive airway pressure therapy for obstructive sleep apnea (OSA). The aim of this registry and purpose of this article were to examine the outcomes of patients receiving UAS for treatment of OSA.</jats:p></jats:sec><jats:sec><jats:title>Study Design</jats:title><jats:p>Cohort Study.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Demographic and sleep study data collection occurred at baseline, implantation visit, post‐titration (6 months), and final visit (12 months). Patient and physician reported outcomes were also collected. Post hoc univariate and multivariate analysis was used to identify predictors of therapy response, defined as ≥50% decrease in Apnea‐Hypopnea Index (AHI) and AHI ≤20 at the 12‐month visit.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The registry has enrolled 1,017 patients from October 2016 through February 2019. Thus far, 640 patients have completed their 6‐month follow‐up and 382 have completed the 12‐month follow‐up. After 12 months, median AHI was reduced from 32.8 (interquartile range [IQR], 23.6–45.0) to 9.5 (IQR, 4.0–18.5); mean, 35.8 ± 15.4 to 14.2 ± 15.0, <jats:italic>P</jats:italic> < .0001. Epworth Sleepiness Scale was similarly improved from 11.0 (IQR, 7–16) to 7.0 (IQR, 4–11); mean, 11.4 ± 5.6 to 7.2 ± 4.8, <jats:italic>P</jats:italic> < .0001. Therapy usage was 5.6 ± 2.1 hours per night after 12 months. In a multivariate model, only female sex and lower baseline body mass index remained as significant predictors of therapy response.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Across a multi‐institutional study, UAS therapy continues to show significant improvement in subjective and objective OSA outcomes. This analysis shows that the therapy effect is durable and adherence is high.</jats:p></jats:sec><jats:sec><jats:title>Level of Evidence</jats:title><jats:p>2</jats:p><jats:p><jats:italic>Laryngoscope</jats:italic>, 130:1333–1338, 2020</jats:p></jats:sec>

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