Erica Thaler1, Richard Schwab2, Joachim Maurer3, Ryan Soose4, Christopher Larsen5, Suzanne Stevens5, Damien Stevens5, Maurits Boon6, Colin Huntley6, Karl Doghramji6, Tina Waters7, Alan Kominsky8, Armin Steffen9, Eric Kezirian10, Benedikt Hofauer11, Ulrich Sommer12, Kirk Withrow13, Kingman Strohl14, Clemens Heiser11. 1. Department of Otorhinolaryngology-Head and Neck Surgery, University of Pennsylvania, Philadelphia, Pennsylvania. 2. Penn Sleep Center, University of Pennsylvania, Philadelphia, Pennsylvania. 3. Sleep Disorders Center, University Hospital Mannheim, Mannheim, Germany. 4. Department of Otolaryngology, University of Pittsburgh, Pittsburgh, Pennsylvania. 5. Department of Otolaryngology-Head and Neck Surgery, University of Kansas Medical Center, Kansas City, Kansas. 6. Department of Otolaryngology-Head and Neck Surgery, Thomas Jefferson University Hospitals, Philadelphia, Pennsylvania. 7. Cleveland Clinic Health System, Cleveland Clinic, Cleveland, Ohio. 8. Head and Neck Institute, Cleveland Clinic, Cleveland, Ohio. 9. Department of Otorhinolaryngology, University of Lübeck, Lübeck, Germany. 10. Department of Otolaryngology-Head and Neck Surgery, Keck School of Medicine at University of Southern California, Los Angeles, California. 11. Department of Otorhinolaryngology-Head and Neck Surgery, Klinikum rechts der Isar, Technical University Munich, Munich, Germany. 12. Department of Otorhinolaryngology-Head and Neck Surgery, University Hospital Mannheim, Mannheim, Germany. 13. Department of Otolaryngology, University of Alabama School of Medicine, Birmingham, Alabama. 14. Department of Medicine, Case Western Reserve University, Cleveland, Ohio, U.S.A.
Abstract
OBJECTIVE/HYPOTHESIS: 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. STUDY DESIGN: Cohort Study. METHODS: 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. RESULTS: 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, P < .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, P < .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. CONCLUSIONS: 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. LEVEL OF EVIDENCE: 2 Laryngoscope, 130:1333-1338, 2020.
OBJECTIVE/HYPOTHESIS: 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. STUDY DESIGN: Cohort Study. METHODS: 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. RESULTS: 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, P < .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, P < .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. CONCLUSIONS: 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. LEVEL OF EVIDENCE: 2 Laryngoscope, 130:1333-1338, 2020.
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