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

Clemens Heiser¹, Armin Steffen², Maurits Boon³, Benedikt Hofauer¹, Karl Doghramji³, Joachim T Maurer⁴, J Ulrich Sommer⁴, Ryan Soose⁵, Patrick J Strollo Jr⁵, Richard Schwab⁶, Erica Thaler⁶, Kirk Withrow⁷, Alan Kominsky⁸, Christopher Larsen⁹, Eric J Kezirian¹⁰, Jennifer Hsia¹¹, Stanley Chia¹², John Harwick¹³, Kingman Strohl¹⁴, Reena Mehra⁸; ADHERE registry investigators

Affiliations

¹ Dept of Otorhinolaryngology, Head and Neck Surgery, Munich Technical University, Munich, Germany.
² Dept of Otorhinolaryngology, University of Lubeck, Lubeck, Germany.
³ Dept of Otorhinolaryngology - Head and Neck Surgery, Thomas Jefferson University, Philadelphia, PA, USA.
⁴ Dept of Otorhinolaryngology, Head and Neck Surgery, HELIOS University Hospital Wuppertal, Wuppertal, Germany.
⁵ Dept of Otorhinolaryngology, University of Pittsburgh, Pittsburgh, PA, USA.
⁶ Dept of Sleep Medicine, University of Pennsylvania, Philadelphia, PA, USA.
⁷ Dept of Otorhinolaryngology, University of Alabama, Birmingham, AL, USA.
⁸ Dept of Otorhinolaryngology, Cleveland Clinic, Cleveland, OH, USA.
⁹ Dept of Otorhinolaryngology - Head and Neck Surgery, Kansas University Medical Center, Kansas City, KS, USA.
¹⁰ Dept of Otorhinolaryngology - Head and Neck Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA.
¹¹ Dept of Otorhinolaryngology - Head and Neck Surgery, University of Minnesota Fairview Hospital, Minneapolis, MN, USA.
¹² Dept of Otorhinolaryngology, MedStar Washington Hospital Center, Washington, DC, USA.
¹³ Dept of Otorhinolaryngology - Head and Neck Surgery, University of Florida, Gainesville, FL, USA.
¹⁴ Dept of Pulmonary and Critical Care Medicine and Sleep Medicine, University Hospital Cleveland Medical Center, Cleveland, OH, USA.

PMID: 30487205
PMCID: PMC6319796
DOI: 10.1183/13993003.01405-2018

Observational Study

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

Clemens Heiser et al. Eur Respir J. 2019.

. 2019 Jan 3;53(1):1801405.

doi: 10.1183/13993003.01405-2018. Print 2019 Jan.

Authors

Affiliations

¹ Dept of Otorhinolaryngology, Head and Neck Surgery, Munich Technical University, Munich, Germany.
² Dept of Otorhinolaryngology, University of Lubeck, Lubeck, Germany.
³ Dept of Otorhinolaryngology - Head and Neck Surgery, Thomas Jefferson University, Philadelphia, PA, USA.
⁴ Dept of Otorhinolaryngology, Head and Neck Surgery, HELIOS University Hospital Wuppertal, Wuppertal, Germany.
⁵ Dept of Otorhinolaryngology, University of Pittsburgh, Pittsburgh, PA, USA.
⁶ Dept of Sleep Medicine, University of Pennsylvania, Philadelphia, PA, USA.
⁷ Dept of Otorhinolaryngology, University of Alabama, Birmingham, AL, USA.
⁸ Dept of Otorhinolaryngology, Cleveland Clinic, Cleveland, OH, USA.
⁹ Dept of Otorhinolaryngology - Head and Neck Surgery, Kansas University Medical Center, Kansas City, KS, USA.
¹⁰ Dept of Otorhinolaryngology - Head and Neck Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA.
¹¹ Dept of Otorhinolaryngology - Head and Neck Surgery, University of Minnesota Fairview Hospital, Minneapolis, MN, USA.
¹² Dept of Otorhinolaryngology, MedStar Washington Hospital Center, Washington, DC, USA.
¹³ Dept of Otorhinolaryngology - Head and Neck Surgery, University of Florida, Gainesville, FL, USA.
¹⁴ Dept of Pulmonary and Critical Care Medicine and Sleep Medicine, University Hospital Cleveland Medical Center, Cleveland, OH, USA.

PMID: 30487205
PMCID: PMC6319796
DOI: 10.1183/13993003.01405-2018

Abstract

Upper airway stimulation (UAS) has been shown to reduce severity of obstructive sleep apnoea. The aim of this study was to identify predictors of UAS therapy response in an international multicentre registry.Patients who underwent UAS implantation in the United States and Germany were enrolled in an observational registry. Data collected included patient characteristics, apnoea/hypopnoea index (AHI), Epworth sleepiness scale (ESS), 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 centres. Median AHI was reduced from 34 to 7 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 body mass index (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 multicentre 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.

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Conflict of interest statement

Conflict of interest: C. Heiser reports grants and personal fees from Inspire Medical Systems (Maple Grove, MN, USA), during the conduct of the study; and grants and personal fees for consultancy from Inspire Medical Systems, outside the submitted work. Conflict of interest: A. 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 Systems. Conflict of interest: M. Boon reports grants from Inspire Medical Systems, during the conduct of the study; and grants and personal fees for consultancy from Inspire Medical Systems, outside the submitted work. Conflict of interest: B. Hofauer reports personal fees from Inspire Medical Systems, during the conduct of the study. Conflict of interest: K. Doghramji reports grants from Inspire Medical Systems, during the conduct of the study; and grants and personal fees from Inspire Medical Systems, outside the submitted work. Conflict of interest: J.T. Maurer reports grants and personal fees for lectures, surgical training and consulting from Inspire Medical Systems, during the conduct of the study; and grants and personal fees for surgical training from Imthera and Revent, grants and personal fees for consultancy from Philipps and Nyxoah, and personal fees for lecturing from GlaxoSmithKline, Heinen und Löwenstein, Weinmann, Sissel Novacare, ResMed, Olympus, Neuwirth Medical and Medtronic, outside the submitted work. Conflict of interest: J.U. Sommer reports grants, personal fees and non-financial support from Inspire Medical Systems, ImThera, Regis Medical, Nyxoah, Phillips, MedEl, and personal fees from Neucomed, during the conduct of the study. Conflict of interest: R. Soose was a consultant and study investigator for Inspire Medical Systems, during the conduct of the study; and carried out advisory board and consultancy work for Galvani Bioelectronics, and was a consultant for Invicta Medical, outside the submitted work. Conflict of interest: P.J. Strollo Jr reports grants and personal fees for consultancy from Inspire Medical Systems and Jazz Pharmaceuticals, and personal fees for consultancy from Philips-Respironics and Itamar Medical, outside the submitted work. Conflict of interest: R. Schwab reports grants from Inspire Medical Systems, during the conduct of the study. Conflict of interest: E. Thaler is a consultant for Inspire Medical Systems, outside the submitted work. Conflict of interest: K. Withrow has nothing to disclose. Conflict of interest: A. Kominsky has nothing to disclose. Conflict of interest: C. Larsen has nothing to disclose. Conflict of interest: E.J. Kezirian reports grants from Inspire Medical Systems, during the conduct of the study; and equity from Nyxoah, Pillar Palatal, Cognitive Life Science, Split Rock Scientific, Gerard Scientific, Berendo Scientific and ReVENT Medical, and grants from Autonomic Technologies, outside the submitted work; and in addition, 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: J. Hsia has nothing to disclose. Conflict of interest: S. Chia has nothing to disclose. Conflict of interest: J. Harwick has nothing to disclose. Conflict of interest: K. Strohl reports grants (as site PI for post-approval studies) from Inspire Medical Systems, during the conduct of the study; and was consultant to Sommetrics and advisor to Galvani Bioelectronics, outside the submitted work. Conflict of interest: R. Mehra reports grants (to institution, to support efforts to collect data for the ADHERE registry) from Inspire Medical Systems, during the conduct of the study; and grants from NIH, equipment for research from Philips Respironics and Resmed, personal fees from American Academy of Sleep Medicine, and royalties from Up to Date, outside the submitted work.

Figures

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

**FIGURE 3**
Clinical Global Impression of the Intervention – Improvement (CGI-I) rated by the physician at post-titration and final visit.

**FIGURE 4**
Patient experience with upper airway stimulation (UAS) at the post-titration and final visits. CPAP: continuous positive airway pressure.

See this image and copyright information in PMC

References

1. Peppard PE, Young T, Barnet JH, et al. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol 2013; 177: 1006–1014. - PMC - PubMed
1. Remmers JE, de Groot WJ, Sauerland EK, et al. Pathogenesis of upper airway occlusion during sleep. J Appl Physiol Respir Environ Exerc Physiol 1978; 44: 931–938. - PubMed
1. Strohl KP, Saunders NA, Feldman NT, et al. Obstructive sleep apnea in family members. N Engl J Med 1978; 299: 969–973. - PubMed
1. Eckert DJ. Phenotypic approaches to obstructive sleep apnoea – new pathways for targeted therapy. Sleep Med Rev 2018; 37: 45–59. - PubMed
1. Dempsey JA, Veasey SC, Morgan BJ, et al. Pathophysiology of sleep apnea. Physiol Rev 2010; 90: 47–112. - PMC - PubMed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources