A novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility

Vaclav Pavelec,1,2 Brian W Rotenberg,3 Joachim T Maurer,4 Edward Gillis,5 Thomas Verse6 1LENTE Clinic, 2Faculty of Health Studies of West Bohemia University, Plzen, Czech Republic; 3Department of Otolaryngology, Head and Neck Surgery, Western University, London, ON, Canada; 4Department of Otorhinola...

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Autores principales:	Pavelec V, Rotenberg BW, Maurer JT, Gillis E, Verse T
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2016
Materias:	Obstructive sleep apnea implantable device surgical treatment breathing sleep tongue base Psychiatry RC435-571 Neurophysiology and neuropsychology QP351-495
Acceso en línea:	https://doaj.org/article/d2a2b6a78c88413f9eb1735f1711b39b
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spelling	oai:doaj.org-article:d2a2b6a78c88413f9eb1735f1711b39b2021-12-02T02:00:24ZA novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility1179-1608https://doaj.org/article/d2a2b6a78c88413f9eb1735f1711b39b2016-05-01T00:00:00Zhttps://www.dovepress.com/a-novel-implantable-device-for-the-treatment-of-obstructive-sleep-apne-peer-reviewed-article-NSShttps://doaj.org/toc/1179-1608Vaclav Pavelec,1,2 Brian W Rotenberg,3 Joachim T Maurer,4 Edward Gillis,5 Thomas Verse6 1LENTE Clinic, 2Faculty of Health Studies of West Bohemia University, Plzen, Czech Republic; 3Department of Otolaryngology, Head and Neck Surgery, Western University, London, ON, Canada; 4Department of Otorhinolaryngology, Head and Neck Surgery, University Medicine Mannheim, Mannheim, Germany; 5ReVENT Medical, Inc., Newark, CA, USA; 6Department of Otorhinolaryngology, Head and Neck Surgery, Asklepios Klinikum Harburg, Hamburg, GermanyObjective: Many cases of obstructive sleep apnea (OSA) involve collapse of the tongue base and soft palate during sleep, causing occlusion of the upper airway and leading to oxygen desaturation. Existing therapies can be effective, but they are plagued by patient adherence issues and the invasiveness of surgical approaches. A new, minimally invasive implant for OSA has been developed, which is elastic and contracts a few weeks after deployment, stabilizing the surrounding soft tissue. The device has had good outcomes in preclinical testing; this report describes the preliminary feasibility and safety of its implementation in humans.Patients and methods: A prospective, multicenter, single-arm feasibility study was conducted. Subjects were adults with moderate-to-severe OSA who had previously failed or refused conventional continuous positive airway pressure treatment. Intraoperative feasibility data, postoperative pain, and safety information were collected for a 30-day postoperative period.Results: Forty subjects participated (37 men, three women; average age of 46.1 years); each received two tongue-base implants and two soft-palate implants. Surgical procedure time averaged 43 minutes. Postsurgical pain resolved readily in most cases; at 30 days post implantation, <20% of subjects reported pain, which averaged less than two out of ten. Adverse events were generally the mild and expected sequelae of a surgical procedure with general anesthesia and intraoral manipulation. The device was well tolerated. Implant extrusions were reported with soft-palate implants (n=12), while tongue-base implants required few revisions (n=2). Quantitative and qualitative sleep effectiveness outcomes (including full-night polysomnographic and quality-of-life measures) will be presented in a subsequent report.Conclusion: Implantation of the device was feasible. Although a relatively high rate of extrusions occurred in the now-discontinued palate implants, tongue-base implants were largely stable and well tolerated. The minimally invasive and maintenance-free implant may provide a new alternative to higher morbidity surgical procedures.Keywords: obstructive sleep apnea, implantable device, surgical treatment, breathing, sleep, tongue basePavelec VRotenberg BWMaurer JTGillis EVerse TDove Medical PressarticleObstructive sleep apneaimplantable devicesurgical treatmentbreathingsleeptongue basePsychiatryRC435-571Neurophysiology and neuropsychologyQP351-495ENNature and Science of Sleep, Vol 2016, Iss Issue 1, Pp 137-144 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	Obstructive sleep apnea implantable device surgical treatment breathing sleep tongue base Psychiatry RC435-571 Neurophysiology and neuropsychology QP351-495
spellingShingle	Obstructive sleep apnea implantable device surgical treatment breathing sleep tongue base Psychiatry RC435-571 Neurophysiology and neuropsychology QP351-495 Pavelec V Rotenberg BW Maurer JT Gillis E Verse T A novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility
description	Vaclav Pavelec,1,2 Brian W Rotenberg,3 Joachim T Maurer,4 Edward Gillis,5 Thomas Verse6 1LENTE Clinic, 2Faculty of Health Studies of West Bohemia University, Plzen, Czech Republic; 3Department of Otolaryngology, Head and Neck Surgery, Western University, London, ON, Canada; 4Department of Otorhinolaryngology, Head and Neck Surgery, University Medicine Mannheim, Mannheim, Germany; 5ReVENT Medical, Inc., Newark, CA, USA; 6Department of Otorhinolaryngology, Head and Neck Surgery, Asklepios Klinikum Harburg, Hamburg, GermanyObjective: Many cases of obstructive sleep apnea (OSA) involve collapse of the tongue base and soft palate during sleep, causing occlusion of the upper airway and leading to oxygen desaturation. Existing therapies can be effective, but they are plagued by patient adherence issues and the invasiveness of surgical approaches. A new, minimally invasive implant for OSA has been developed, which is elastic and contracts a few weeks after deployment, stabilizing the surrounding soft tissue. The device has had good outcomes in preclinical testing; this report describes the preliminary feasibility and safety of its implementation in humans.Patients and methods: A prospective, multicenter, single-arm feasibility study was conducted. Subjects were adults with moderate-to-severe OSA who had previously failed or refused conventional continuous positive airway pressure treatment. Intraoperative feasibility data, postoperative pain, and safety information were collected for a 30-day postoperative period.Results: Forty subjects participated (37 men, three women; average age of 46.1 years); each received two tongue-base implants and two soft-palate implants. Surgical procedure time averaged 43 minutes. Postsurgical pain resolved readily in most cases; at 30 days post implantation, <20% of subjects reported pain, which averaged less than two out of ten. Adverse events were generally the mild and expected sequelae of a surgical procedure with general anesthesia and intraoral manipulation. The device was well tolerated. Implant extrusions were reported with soft-palate implants (n=12), while tongue-base implants required few revisions (n=2). Quantitative and qualitative sleep effectiveness outcomes (including full-night polysomnographic and quality-of-life measures) will be presented in a subsequent report.Conclusion: Implantation of the device was feasible. Although a relatively high rate of extrusions occurred in the now-discontinued palate implants, tongue-base implants were largely stable and well tolerated. The minimally invasive and maintenance-free implant may provide a new alternative to higher morbidity surgical procedures.Keywords: obstructive sleep apnea, implantable device, surgical treatment, breathing, sleep, tongue base
format	article
author	Pavelec V Rotenberg BW Maurer JT Gillis E Verse T
author_facet	Pavelec V Rotenberg BW Maurer JT Gillis E Verse T
author_sort	Pavelec V
title	A novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility
title_short	A novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility
title_full	A novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility
title_fullStr	A novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility
title_full_unstemmed	A novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility
title_sort	novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility
publisher	Dove Medical Press
publishDate	2016
url	https://doaj.org/article/d2a2b6a78c88413f9eb1735f1711b39b
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A novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility

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