Upper Airway Stimulation for Obstructive Sleep Apnea: 5-Year Outcomes
Objective To present 5-year outcomes from a prospective cohort of patients with obstructive sleep apnea (OSA) who were treated with upper airway stimulation (UAS) via a unilateral hypoglossal nerve implant. Study Design A multicenter prospective cohort study. Setting Industry-supported multicenter a...
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| Veröffentlicht in: | Otolaryngology-head and neck surgery 2018-07, Vol.159 (1), p.194-202 |
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| creator | Woodson, B. Tucker Strohl, Kingman P. Soose, Ryan J. Gillespie, M. Boyd Maurer, Joachim T. de Vries, Nico Padhya, Tapan A. Badr, M. Safwan Lin, Ho-sheng Vanderveken, Olivier M. Mickelson, Sam Strollo, Patrick J. |
| description | Objective
To present 5-year outcomes from a prospective cohort of patients with obstructive sleep apnea (OSA) who were treated with upper airway stimulation (UAS) via a unilateral hypoglossal nerve implant.
Study Design
A multicenter prospective cohort study.
Setting
Industry-supported multicenter academic and clinical trial.
Methods
From a cohort of 126 patients, 97 completed protocol, and 71 consented to a voluntary polysomnogram. Those having continuous positive airway pressure failure with moderate to severe OSA, body mass index |
| doi_str_mv | 10.1177/0194599818762383 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2019047008</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.1177_0194599818762383</sage_id><sourcerecordid>2019047008</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4943-586e637c1bf5282e2a06b66be5dec6d5053dda414616ebfdbcf3485fa2a0c4323</originalsourceid><addsrcrecordid>eNqFkDtPwzAUhS0EoqWwM6GMLAE_4kfYStVSJESH0oHJcpwblCppgp1Q9d-TksKAhJg8nO87uj4IXRJ8Q4iUt5jEEY9jRZQUlCl2hIYExzIUishjNNzH4T4foDPv1xhjIaQ8RQMac0UlZkM0XdU1uGCcu63ZBcsmL9vCNHm1CbLKBYvEN661Tf4BwbIAqINxvQFzF_DwFUyXt42tSvDn6CQzhYeLwztCq9n0ZTIPnxYPj5PxU2ijOGIhVwIEk5YkGaeKAjVYJEIkwFOwIuWYszQ1EYkEEZBkaWIzFimemQ60EaNshK773tpV7y34Rpe5t1AUZgNV6zXtfowjibHqUNyj1lXeO8h07fLSuJ0mWO_H07_H65SrQ3ublJD-CN9rdYDqgW1ewO7fQr2YP9_PCKVfatir3ryBXlet23RD_X3LJ5jthdQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2019047008</pqid></control><display><type>article</type><title>Upper Airway Stimulation for Obstructive Sleep Apnea: 5-Year Outcomes</title><source>Wiley Online Library Journals Frontfile Complete</source><source>SAGE Complete</source><creator>Woodson, B. Tucker ; Strohl, Kingman P. ; Soose, Ryan J. ; Gillespie, M. Boyd ; Maurer, Joachim T. ; de Vries, Nico ; Padhya, Tapan A. ; Badr, M. Safwan ; Lin, Ho-sheng ; Vanderveken, Olivier M. ; Mickelson, Sam ; Strollo, Patrick J.</creator><creatorcontrib>Woodson, B. Tucker ; Strohl, Kingman P. ; Soose, Ryan J. ; Gillespie, M. Boyd ; Maurer, Joachim T. ; de Vries, Nico ; Padhya, Tapan A. ; Badr, M. Safwan ; Lin, Ho-sheng ; Vanderveken, Olivier M. ; Mickelson, Sam ; Strollo, Patrick J.</creatorcontrib><description>Objective
To present 5-year outcomes from a prospective cohort of patients with obstructive sleep apnea (OSA) who were treated with upper airway stimulation (UAS) via a unilateral hypoglossal nerve implant.
Study Design
A multicenter prospective cohort study.
Setting
Industry-supported multicenter academic and clinical trial.
Methods
From a cohort of 126 patients, 97 completed protocol, and 71 consented to a voluntary polysomnogram. Those having continuous positive airway pressure failure with moderate to severe OSA, body mass index <32 kg/m2, and no unfavorable collapse on drug-induced sleep endoscopy were enrolled in a phase 3 trial. Prospective outcomes included apnea-hypopnea index (AHI), oxygen desaturation index, and adverse events, as well as measures of sleepiness, quality of life, and snoring.
Results
Patients who did and did not complete the protocol differed in baseline AHI, oxygen desaturation index, and Functional Outcomes of Sleep Questionnaire scores but not in any other demographics or treatment response measures. Improvement in sleepiness (Epworth Sleepiness Scale) and quality of life was observed, with normalization of scores increasing from 33% to 78% and 15% to 67%, respectively. AHI response rate (AHI <20 events per hour and >50% reduction) was 75% (n = 71). When a last observation carried forward analysis was applied, the responder rate was 63% at 5 years. Serious device-related events all related to lead/device adjustments were reported in 6% of patients.
Conclusions
Improvements in sleepiness, quality of life, and respiratory outcomes are observed with 5 years of UAS. Serious adverse events are uncommon. UAS is a nonanatomic surgical treatment with long-term benefit for individuals with moderate to severe OSA who have failed nasal continuous positive airway pressure.</description><identifier>ISSN: 0194-5998</identifier><identifier>EISSN: 1097-6817</identifier><identifier>DOI: 10.1177/0194599818762383</identifier><identifier>PMID: 29582703</identifier><language>eng</language><publisher>Los Angeles, CA: SAGE Publications</publisher><subject>cranial nerve ; device ; device apnea hypopnea index ; hypoglossal nerve ; implant ; long term ; obstructive sleep apnea ; polysomnogram ; quality of life ; sleep ; sleepiness ; surgery ; upper airway stimulation</subject><ispartof>Otolaryngology-head and neck surgery, 2018-07, Vol.159 (1), p.194-202</ispartof><rights>American Academy of Otolaryngology—Head and Neck Surgery Foundation 2018</rights><rights>2018 American Association of Otolaryngology‐Head and Neck Surgery Foundation (AAO‐HNSF)</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4943-586e637c1bf5282e2a06b66be5dec6d5053dda414616ebfdbcf3485fa2a0c4323</citedby><cites>FETCH-LOGICAL-c4943-586e637c1bf5282e2a06b66be5dec6d5053dda414616ebfdbcf3485fa2a0c4323</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/0194599818762383$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/0194599818762383$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,776,780,1411,21798,27901,27902,43597,43598,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29582703$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Woodson, B. Tucker</creatorcontrib><creatorcontrib>Strohl, Kingman P.</creatorcontrib><creatorcontrib>Soose, Ryan J.</creatorcontrib><creatorcontrib>Gillespie, M. Boyd</creatorcontrib><creatorcontrib>Maurer, Joachim T.</creatorcontrib><creatorcontrib>de Vries, Nico</creatorcontrib><creatorcontrib>Padhya, Tapan A.</creatorcontrib><creatorcontrib>Badr, M. Safwan</creatorcontrib><creatorcontrib>Lin, Ho-sheng</creatorcontrib><creatorcontrib>Vanderveken, Olivier M.</creatorcontrib><creatorcontrib>Mickelson, Sam</creatorcontrib><creatorcontrib>Strollo, Patrick J.</creatorcontrib><title>Upper Airway Stimulation for Obstructive Sleep Apnea: 5-Year Outcomes</title><title>Otolaryngology-head and neck surgery</title><addtitle>Otolaryngol Head Neck Surg</addtitle><description>Objective
To present 5-year outcomes from a prospective cohort of patients with obstructive sleep apnea (OSA) who were treated with upper airway stimulation (UAS) via a unilateral hypoglossal nerve implant.
Study Design
A multicenter prospective cohort study.
Setting
Industry-supported multicenter academic and clinical trial.
Methods
From a cohort of 126 patients, 97 completed protocol, and 71 consented to a voluntary polysomnogram. Those having continuous positive airway pressure failure with moderate to severe OSA, body mass index <32 kg/m2, and no unfavorable collapse on drug-induced sleep endoscopy were enrolled in a phase 3 trial. Prospective outcomes included apnea-hypopnea index (AHI), oxygen desaturation index, and adverse events, as well as measures of sleepiness, quality of life, and snoring.
Results
Patients who did and did not complete the protocol differed in baseline AHI, oxygen desaturation index, and Functional Outcomes of Sleep Questionnaire scores but not in any other demographics or treatment response measures. Improvement in sleepiness (Epworth Sleepiness Scale) and quality of life was observed, with normalization of scores increasing from 33% to 78% and 15% to 67%, respectively. AHI response rate (AHI <20 events per hour and >50% reduction) was 75% (n = 71). When a last observation carried forward analysis was applied, the responder rate was 63% at 5 years. Serious device-related events all related to lead/device adjustments were reported in 6% of patients.
Conclusions
Improvements in sleepiness, quality of life, and respiratory outcomes are observed with 5 years of UAS. Serious adverse events are uncommon. UAS is a nonanatomic surgical treatment with long-term benefit for individuals with moderate to severe OSA who have failed nasal continuous positive airway pressure.</description><subject>cranial nerve</subject><subject>device</subject><subject>device apnea hypopnea index</subject><subject>hypoglossal nerve</subject><subject>implant</subject><subject>long term</subject><subject>obstructive sleep apnea</subject><subject>polysomnogram</subject><subject>quality of life</subject><subject>sleep</subject><subject>sleepiness</subject><subject>surgery</subject><subject>upper airway stimulation</subject><issn>0194-5998</issn><issn>1097-6817</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><recordid>eNqFkDtPwzAUhS0EoqWwM6GMLAE_4kfYStVSJESH0oHJcpwblCppgp1Q9d-TksKAhJg8nO87uj4IXRJ8Q4iUt5jEEY9jRZQUlCl2hIYExzIUishjNNzH4T4foDPv1xhjIaQ8RQMac0UlZkM0XdU1uGCcu63ZBcsmL9vCNHm1CbLKBYvEN661Tf4BwbIAqINxvQFzF_DwFUyXt42tSvDn6CQzhYeLwztCq9n0ZTIPnxYPj5PxU2ijOGIhVwIEk5YkGaeKAjVYJEIkwFOwIuWYszQ1EYkEEZBkaWIzFimemQ60EaNshK773tpV7y34Rpe5t1AUZgNV6zXtfowjibHqUNyj1lXeO8h07fLSuJ0mWO_H07_H65SrQ3ublJD-CN9rdYDqgW1ewO7fQr2YP9_PCKVfatir3ryBXlet23RD_X3LJ5jthdQ</recordid><startdate>201807</startdate><enddate>201807</enddate><creator>Woodson, B. Tucker</creator><creator>Strohl, Kingman P.</creator><creator>Soose, Ryan J.</creator><creator>Gillespie, M. Boyd</creator><creator>Maurer, Joachim T.</creator><creator>de Vries, Nico</creator><creator>Padhya, Tapan A.</creator><creator>Badr, M. Safwan</creator><creator>Lin, Ho-sheng</creator><creator>Vanderveken, Olivier M.</creator><creator>Mickelson, Sam</creator><creator>Strollo, Patrick J.</creator><general>SAGE Publications</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201807</creationdate><title>Upper Airway Stimulation for Obstructive Sleep Apnea: 5-Year Outcomes</title><author>Woodson, B. Tucker ; Strohl, Kingman P. ; Soose, Ryan J. ; Gillespie, M. Boyd ; Maurer, Joachim T. ; de Vries, Nico ; Padhya, Tapan A. ; Badr, M. Safwan ; Lin, Ho-sheng ; Vanderveken, Olivier M. ; Mickelson, Sam ; Strollo, Patrick J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4943-586e637c1bf5282e2a06b66be5dec6d5053dda414616ebfdbcf3485fa2a0c4323</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>cranial nerve</topic><topic>device</topic><topic>device apnea hypopnea index</topic><topic>hypoglossal nerve</topic><topic>implant</topic><topic>long term</topic><topic>obstructive sleep apnea</topic><topic>polysomnogram</topic><topic>quality of life</topic><topic>sleep</topic><topic>sleepiness</topic><topic>surgery</topic><topic>upper airway stimulation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Woodson, B. Tucker</creatorcontrib><creatorcontrib>Strohl, Kingman P.</creatorcontrib><creatorcontrib>Soose, Ryan J.</creatorcontrib><creatorcontrib>Gillespie, M. Boyd</creatorcontrib><creatorcontrib>Maurer, Joachim T.</creatorcontrib><creatorcontrib>de Vries, Nico</creatorcontrib><creatorcontrib>Padhya, Tapan A.</creatorcontrib><creatorcontrib>Badr, M. Safwan</creatorcontrib><creatorcontrib>Lin, Ho-sheng</creatorcontrib><creatorcontrib>Vanderveken, Olivier M.</creatorcontrib><creatorcontrib>Mickelson, Sam</creatorcontrib><creatorcontrib>Strollo, Patrick J.</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Otolaryngology-head and neck surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Woodson, B. Tucker</au><au>Strohl, Kingman P.</au><au>Soose, Ryan J.</au><au>Gillespie, M. Boyd</au><au>Maurer, Joachim T.</au><au>de Vries, Nico</au><au>Padhya, Tapan A.</au><au>Badr, M. Safwan</au><au>Lin, Ho-sheng</au><au>Vanderveken, Olivier M.</au><au>Mickelson, Sam</au><au>Strollo, Patrick J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Upper Airway Stimulation for Obstructive Sleep Apnea: 5-Year Outcomes</atitle><jtitle>Otolaryngology-head and neck surgery</jtitle><addtitle>Otolaryngol Head Neck Surg</addtitle><date>2018-07</date><risdate>2018</risdate><volume>159</volume><issue>1</issue><spage>194</spage><epage>202</epage><pages>194-202</pages><issn>0194-5998</issn><eissn>1097-6817</eissn><abstract>Objective
To present 5-year outcomes from a prospective cohort of patients with obstructive sleep apnea (OSA) who were treated with upper airway stimulation (UAS) via a unilateral hypoglossal nerve implant.
Study Design
A multicenter prospective cohort study.
Setting
Industry-supported multicenter academic and clinical trial.
Methods
From a cohort of 126 patients, 97 completed protocol, and 71 consented to a voluntary polysomnogram. Those having continuous positive airway pressure failure with moderate to severe OSA, body mass index <32 kg/m2, and no unfavorable collapse on drug-induced sleep endoscopy were enrolled in a phase 3 trial. Prospective outcomes included apnea-hypopnea index (AHI), oxygen desaturation index, and adverse events, as well as measures of sleepiness, quality of life, and snoring.
Results
Patients who did and did not complete the protocol differed in baseline AHI, oxygen desaturation index, and Functional Outcomes of Sleep Questionnaire scores but not in any other demographics or treatment response measures. Improvement in sleepiness (Epworth Sleepiness Scale) and quality of life was observed, with normalization of scores increasing from 33% to 78% and 15% to 67%, respectively. AHI response rate (AHI <20 events per hour and >50% reduction) was 75% (n = 71). When a last observation carried forward analysis was applied, the responder rate was 63% at 5 years. Serious device-related events all related to lead/device adjustments were reported in 6% of patients.
Conclusions
Improvements in sleepiness, quality of life, and respiratory outcomes are observed with 5 years of UAS. Serious adverse events are uncommon. UAS is a nonanatomic surgical treatment with long-term benefit for individuals with moderate to severe OSA who have failed nasal continuous positive airway pressure.</abstract><cop>Los Angeles, CA</cop><pub>SAGE Publications</pub><pmid>29582703</pmid><doi>10.1177/0194599818762383</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0194-5998 |
| ispartof | Otolaryngology-head and neck surgery, 2018-07, Vol.159 (1), p.194-202 |
| issn | 0194-5998 1097-6817 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2019047008 |
| source | Wiley Online Library Journals Frontfile Complete; SAGE Complete |
| subjects | cranial nerve device device apnea hypopnea index hypoglossal nerve implant long term obstructive sleep apnea polysomnogram quality of life sleep sleepiness surgery upper airway stimulation |
| title | Upper Airway Stimulation for Obstructive Sleep Apnea: 5-Year Outcomes |
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