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Post-approval upper airway stimulation predictors of treatment effectiveness in the ADHERE registry

Clemens Heiser, Armin Steffen, Maurits Boon, Benedikt Hofauer, Karl Doghramji, Joachim T. Maurer, J. Ulrich Sommer, Ryan Soose, Patrick J. Strollo Jr, Richard Schwab, Erica Thaler, Kirk Withrow, Alan Kominsky, Christopher Larsen, Eric J. Kezirian, Jennifer Hsia, Stanley Chia, John Harwick, Kingman Strohl, Reena Mehra on behalf of the ADHERE registry investigators
European Respiratory Journal 2019 53: 1801405; DOI: 10.1183/13993003.01405-2018
Clemens Heiser
1Dept of Otorhinolaryngology, Head and Neck Surgery, Munich Technical University, Munich, Germany
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Armin Steffen
2Dept of Otorhinolaryngology, University of Lubeck, Lubeck, Germany
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Maurits Boon
3Dept of Otorhinolaryngology – Head and Neck Surgery, Thomas Jefferson University, Philadelphia, PA, USA
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Benedikt Hofauer
1Dept of Otorhinolaryngology, Head and Neck Surgery, Munich Technical University, Munich, Germany
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Karl Doghramji
3Dept of Otorhinolaryngology – Head and Neck Surgery, Thomas Jefferson University, Philadelphia, PA, USA
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Joachim T. Maurer
4Dept of Otorhinolaryngology, Head and Neck Surgery, HELIOS University Hospital Wuppertal, Wuppertal, Germany
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J. Ulrich Sommer
4Dept of Otorhinolaryngology, Head and Neck Surgery, HELIOS University Hospital Wuppertal, Wuppertal, Germany
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Ryan Soose
5Dept of Otorhinolaryngology, University of Pittsburgh, Pittsburgh, PA, USA
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Patrick J. Strollo Jr
5Dept of Otorhinolaryngology, University of Pittsburgh, Pittsburgh, PA, USA
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Richard Schwab
6Dept of Sleep Medicine, University of Pennsylvania, Philadelphia, PA, USA
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Erica Thaler
6Dept of Sleep Medicine, University of Pennsylvania, Philadelphia, PA, USA
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Kirk Withrow
7Dept of Otorhinolaryngology, University of Alabama, Birmingham, AL, USA
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Alan Kominsky
8Dept of Otorhinolaryngology, Cleveland Clinic, Cleveland, OH, USA
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Christopher Larsen
9Dept of Otorhinolaryngology – Head and Neck Surgery, Kansas University Medical Center, Kansas City, KS, USA
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Eric J. Kezirian
10Dept of Otorhinolaryngology – Head and Neck Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA
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Jennifer Hsia
11Dept of Otorhinolaryngology – Head and Neck Surgery, University of Minnesota Fairview Hospital, Minneapolis, MN, USA
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Stanley Chia
12Dept of Otorhinolaryngology, MedStar Washington Hospital Center, Washington, DC, USA
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John Harwick
13Dept of Otorhinolaryngology – Head and Neck Surgery, University of Florida, Gainesville, FL, USA
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Kingman Strohl
14Dept of Pulmonary and Critical Care Medicine and Sleep Medicine, University Hospital Cleveland Medical Center, Cleveland, OH, USA
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Reena Mehra
8Dept of Otorhinolaryngology, Cleveland Clinic, Cleveland, OH, USA
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  • Article
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Figures

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  • FIGURE 1
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    FIGURE 1

    Changes in apnoea/hypopnoea index (AHI) from baseline to post-titration and final visit results. Data are presented as mean+sd.

  • FIGURE 2
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    FIGURE 2

    Changes in Epworth sleepiness scale (ESS) from baseline to post-titration and final visit results. Data are presented as mean+sd

  • FIGURE 3
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    FIGURE 3

    Clinical Global Impression of the Intervention – Improvement (CGI-I) rated by the physician at post-titration and final visit.

  • FIGURE 4
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    FIGURE 4

    Patient experience with upper airway stimulation (UAS) at the post-titration and final visits. CPAP: continuous positive airway pressure.

Tables

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  • TABLE 1

    Baseline characteristics of the registry participants

    Subjects n508
    Age years59.4±11.2
    Sex
     Male399 (79)
     Female109 (21)
    Race
     Caucasian491 (97)
     Other7 (1)
     Black6 (1)
     Asian2 (<1)
     American Indian or Alaska Native2 (<1)
    BMI kg·m−229.3±3.9
    Systolic blood pressure mmHg130±13
    Diastolic blood pressure mmHg78±9
    AHI events·h−136.3±15.7
    ESS11.8±5.5
    Hypertension46.5
    Depression21.3
    Diabetes mellitus11.2
    Atrial fibrillation5.4
    Myocardial infarction3.8
    Stroke2.5

    Data are presented as mean±sd, n (%) or %, unless otherwise stated. BMI: body mass index; AHI: apnoea/hypopnoea index; ESS: Epworth sleepiness scale.

    • TABLE 2

      Summary of post-operative adverse events

      Post-titrationFinal visit
      Events
      n
      Patients %Events
      n
      Patients %
      Tongue weakness2<10
      Swallowing or speech related3<10
      Discomfort (incision/scar)5152
      Discomfort (device)7231
      Infection00
      Post-operative – other#8231
      Stimulation-related discomfort268156
      Tongue abrasion7273
      Insomnia/arousal6293
      Revision interventions (including explant)01<1
      Other discomfort512<1
      Activation – other185166
      Total87236123

      72 patients reported adverse events at the post-titration visit and 50 at the final visit (not mutually exclusive). Some patients reported multiple adverse events. Percentage of patients was calculated based on the number of patients at each visit who completed the visit form, which contains adverse event information. #: includes shortness of breath, seroma, numbness of the throat and hoarseness during the day and a mild tongue-base and epiglottic obstruction.

      • TABLE 3

        Logistic regression univariate analysis of predictors of obstructive sleep apnoea treatment success at the final visit (median time 373 days)

        OR (95% CI)p-value
        Age (baseline) years1.04 (1.01–1.08)0.01
        Sex (female versus male)2.62 (0.88–7.78)0.08
        BMI (baseline) kg·m−20.91 (0.83–0.99)0.03
        AHI (baseline) events·h−11.00 (0.98–1.03)0.88
        Therapy hours per week at post-titration visit1.04 (0.99–1.67)0.25
        Therapy hours per week at final visit1.02 (0.99–1.04)0.22
        Bilateral protrusion versus right protrusion2.08 (0.96–4.51)0.37
        Other versus right protrusion2.03 (0.50–8.21)0.61

        A multivariable model was fit with stepwise selection used to reduce the model to retain only significant parameters (age and body mass index (BMI)) and only age was retained. AHI: apnoea/hypopnoea index.

        • TABLE 4

          Logistic regression of univariate analysis to assess for predictors of upper airway stimulation adherence (≥28 h per week) at the final visit

          Univariable results
          OR (95% CI)p-value
          Age at consent1.04 (1.01–1.07)0.01
          Sex (female versus male)2.14(0.79–5.77)0.14
          BMI at baseline0.90 (0.83–0.97)0.009
          Baseline AHI0.98 (0.96–0.999)0.04
          Bilateral protrusion versus right protrusion0.92 (0.41–2.11)0.59
          Other versus right protrusion1.33 (0.32–5.59)0.62
          Change in AHI at post-titration visit1.01 (0.99–1.04)0.19
          Change in ESS at post-titration visit0.98 (0.91–1.05)0.57
          AHI success at post-titration visit0.99 (0.42–2.34)0.98
          Improvement by CGI at post-titration visit0.67 (0.30–1.51)0.33
          Patient satisfied or strongly satisfied at post-titration0.60 (0.15–2.47)0.48
          Therapy use at post-titration1.08 (1.05–1.11)<0.0001
          Therapy use ≥28 h per week at post-titration0.19 (0.07–0.48)0.0004

          A multivariable model was fit with stepwise selection used to reduce the model to retain only significant parameters (age, body mass index (BMI), apnoea/hypopnoea index (AHI) and therapy at post-titration) and only BMI and therapy use at post-titration visit was retained. ESS: Epworth sleepiness scale; CGI: Clinical Global Impressions scale.

          Supplementary Materials

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            Supplementary tables ERJ-01405-2018_Supplement

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          Post-approval upper airway stimulation predictors of treatment effectiveness in the ADHERE registry
          Clemens Heiser, Armin Steffen, Maurits Boon, Benedikt Hofauer, Karl Doghramji, Joachim T. Maurer, J. Ulrich Sommer, Ryan Soose, Patrick J. Strollo, Richard Schwab, Erica Thaler, Kirk Withrow, Alan Kominsky, Christopher Larsen, Eric J. Kezirian, Jennifer Hsia, Stanley Chia, John Harwick, Kingman Strohl, Reena Mehra
          European Respiratory Journal Jan 2019, 53 (1) 1801405; DOI: 10.1183/13993003.01405-2018

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          Post-approval upper airway stimulation predictors of treatment effectiveness in the ADHERE registry
          Clemens Heiser, Armin Steffen, Maurits Boon, Benedikt Hofauer, Karl Doghramji, Joachim T. Maurer, J. Ulrich Sommer, Ryan Soose, Patrick J. Strollo, Richard Schwab, Erica Thaler, Kirk Withrow, Alan Kominsky, Christopher Larsen, Eric J. Kezirian, Jennifer Hsia, Stanley Chia, John Harwick, Kingman Strohl, Reena Mehra
          European Respiratory Journal Jan 2019, 53 (1) 1801405; DOI: 10.1183/13993003.01405-2018
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