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Post-Approval Upper Airway Stimulation Predictors of Treatment Efficacy 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 2018; DOI: 10.1183/13993003.01405-2018
Clemens Heiser
1Munich Technical University, Germany
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Armin Steffen
2University of Lubeck, Germany
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Maurits Boon
3Thomas Jefferson University
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Benedikt Hofauer
1Munich Technical University, Germany
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Karl Doghramji
3Thomas Jefferson University
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Joachim T. Maurer
4University-Hospital Mannheim, Germany
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J. Ulrich Sommer
4University-Hospital Mannheim, Germany
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Ryan Soose
5University of Pittsburgh, Pittsburgh, PA
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Patrick J. Strollo Jr
5University of Pittsburgh, Pittsburgh, PA
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Richard Schwab
6University of Pennsylvania, Philadelphia, PA
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Erica Thaler
6University of Pennsylvania, Philadelphia, PA
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Kirk Withrow
7University of Alabama, Birmingham, AL
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Alan Kominsky
8Cleveland Clinic
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Christopher Larsen
9Kansas University Medical Center
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Eric J. Kezirian
10Keck School of Medicine of the University of Southern California, Los Angeles, CA
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Jennifer Hsia
11University of Minnesota Fairview Hospital
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Stanley Chia
12MedStar Washington Hospital Center, Washington, DC
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John Harwick
13University of Florida, Gainesville
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Kingman Strohl
14University Hospital Cleveland Medical Center, Cleveland, OH
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Reena Mehra
8Cleveland Clinic
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Abstract

Upper airway stimulation (UAS) has been shown to reduce severity of obstructive sleep apnea (OSA). The aim of this registry was to identify predictors of UAS therapy response in an international multicenter registry. Patients who underwent UAS implantation in the US and Germany were enrolled in an observational registry. Data collected included patient characteristics, apnea-hypopnea index (AHI), Epworth Sleepiness Scale, objective adherence, adverse events, and patient satisfaction measures. Post hoc univariate and multiple logistic regression were performed to evaluate factors associated with treatment success. Between October 2016 and January 2018, 508 participants were enrolled from 14 centers. Median AHI was reduced from 34.0 to 7.0 events·h−1, median ESS reduced from 12 to 7 from baseline to final visit at 12-month post-implant. In post hoc analyses, for each 1-year increase in age, there was a 4% increase in odds of treatment success. For each 1 unit increase in BMI, there was 9% reduced odds of treatment success. In the multivariable model, age persisted in serving as statistically significant predictor of treatment success.

In a large multicenter international registry, UAS is an effective treatment option with high patient satisfaction and low adverse events. Increasing age and reduced BMI are predictors of treatment response.

Footnotes

This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.

Conflict of interest: Dr. Heiser reports grants and personal fees from Inspire Medical Systems (Maple Grove, MN, USA), during the conduct of the study; grants and personal fees from Inspire Medical Systems (Maple Grove, MN, USA), outside the submitted work.

Conflict of interest: Armin Steffen has received reimbursement of conference fees and travel and accommodation expenses, fees for preparing scientific continuing professional development or other events, funding for research he himself initiated, and fees for conducting clinical studies on related subjects from inspire Medical System, Inc.

Conflict of interest: Dr. Boon reports grants from Inspire Medical, during the conduct of the study; personal fees and other from Inspire Medical, grants from Inspire Medical, outside the submitted work.

Conflict of interest: Dr. Hofauer reports personal fees from Inspire Medical Systems, during the conduct of the study.

Conflict of interest: Dr. Doghramji reports grants from Inspire Medical Systems, during the conduct of the study; grants and personal fees from Inspire Medical Systems, outside the submitted work.

Conflict of interest: Dr. Maurer reports grants from Inspire Medical, personal fees from Inspire Medical, during the conduct of the study; grants from Imthera, grants from Revent, grants from Philipps, personal fees from Revent, personal fees from GlaxoSmithKline, personal fees from Heinen und Löwenstein, personal fees from Weinmann, personal fees from Sissel Novacare, personal fees from ResMed, personal fees from Olympus, personal fees from Neuwirth Medical, personal fees from Medtronic, outside the submitted work.

Conflict of interest: Dr. Soose reports other from Inspire Medical Systems, during the conduct of the study; other from Galvani Bioelectronics, other from Invicta Medical, outside the submitted work.

Conflict of interest: Dr. Strollo reports grants and personal fees from Inspire Medical Systems, personal fees from Philips-Respironics, grants and personal fees from Jazz Pharmaceuticals, personal fees from Itamar Medical, outside the submitted work.

Conflict of interest: Dr. Schwab reports grants from Inspire Medical Systems, during the conduct of the study.

Conflict of interest: Dr. Thaler reports other from Inspire, outside the submitted work.

Conflict of interest: Dr. Withrow has nothing to disclose.

Conflict of interest: Dr. Kominsky has nothing to disclose.

Conflict of interest: Dr. Larsen has nothing to disclose.

Conflict of interest: Dr. Kezirian reports grants from Inspire Medical Systems, during the conduct of the study; other from Nyxoah, other from Pillar Palatal, other from Cognitive Life Science, other from Split Rock Scientific, other from Gerard Scientific, other from Berendo Scientific, other from ReVENT Medical, grants from Autonomic Technologies, outside the submitted work; In addition, Dr. Kezirian has a patent Magnap issued, a patent Endoscopic Device and System issued, a patent Head and Neck Exercise Methods pending, and a patent Airway and Airflow Factors issued.

Conflict of interest: Dr. Hsia has nothing to disclose.

Conflict of interest: Dr. Chia has nothing to disclose.

Conflict of interest: Dr. Harwick has nothing to disclose.

Conflict of interest: Dr. Strohl reports grants from Inspire Medical Systems, during the conduct of the study; other from Sommetrics and other from Galvani Bioelectronics, outside the submitted work.

Conflict of interest: Dr. Mehra reports grants from Inspire, during the conduct of the study; grants from NIH, other from Philips Respironics, other from Resmed, from American Academy of Sleep Medicine, from Up to Date, outside the submitted work.

Conflict of interest: Prof. Sommer reports grants, personal fees and non-financial support from Inspire, ImThera, Regis Medical, Nyxoah, Phillips, MedEl, and personal fees from Neucomed, during the conduct of the study.

This is a PDF-only article. Please click on the PDF link above to read it.

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Post-Approval Upper Airway Stimulation Predictors of Treatment Efficacy 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 2018, 1801405; DOI: 10.1183/13993003.01405-2018

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Post-Approval Upper Airway Stimulation Predictors of Treatment Efficacy 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 2018, 1801405; DOI: 10.1183/13993003.01405-2018
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