TY - JOUR
T1 - Results of the ADHERE upper airway stimulation registry and predictors of therapy efficacy
AU - Thaler, Erica
AU - Schwab, Richard
AU - Maurer, Joachim
AU - Soose, Ryan
AU - Larsen, Christopher
AU - Stevens, Suzanne
AU - Stevens, Damien
AU - Boon, Maurits
AU - Huntley, Colin
AU - Doghramji, Karl
AU - Waters, Tina
AU - Kominsky, Alan
AU - Steffen, Armin
AU - Kezirian, Eric
AU - Hofauer, Benedikt
AU - Sommer, Ulrich
AU - Withrow, Kirk
AU - Strohl, Kingman
AU - Heiser, Clemens
N1 - Funding Information:
The authors thank medical illustrator Dominique Bohorquez for her work on Figure.
Publisher Copyright:
© 2019 The Authors. The Laryngoscope published by Wiley Periodicals, Inc. on behalf of The American Laryngological, Rhinological and Otological Society, Inc.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/5/1
Y1 - 2020/5/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85073982235&partnerID=8YFLogxK
U2 - 10.1002/lary.28286
DO - 10.1002/lary.28286
M3 - Journal articles
C2 - 31520484
AN - SCOPUS:85073982235
SN - 0023-852X
VL - 130
SP - 1333
EP - 1338
JO - Laryngoscope
JF - Laryngoscope
IS - 5
ER -