Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial
Objectives/Hypothesis To assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dilatory dysfunction. Study Design In this prospective, multicenter, randomized, controlled trial, we assigned, in a 2...
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| Veröffentlicht in: | The Laryngoscope 2018-05, Vol.128 (5), p.1200-1206 |
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| creator | Poe, Dennis Anand, Vijay Dean, Marc Roberts, William H. Stolovitzky, Jose Pablo Hoffmann, Karen Nachlas, Nathan E. Light, Joshua P. Widick, Mark H. Sugrue, John P. Elliott, C. Layton Rosenberg, Seth I. Guillory, Paul Brown, Neil Syms, Charles A. Hilton, Christopher W. McElveen, John T. Singh, Ameet Weiss, Raymond L. Arriaga, Moises A. Leopold, John P. |
| description | Objectives/Hypothesis
To assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dilatory dysfunction.
Study Design
In this prospective, multicenter, randomized, controlled trial, we assigned, in a 2:1 ratio, patients age 22 years and older with Eustachian tube dilatory dysfunction refractory to medical therapy to undergo balloon dilation of the Eustachian tube with balloon catheter in conjunction with medical management or medical management alone.
Methods
The primary endpoint was normalization of tympanogram at 6 weeks. Additional endpoints were normalization of Eustachian Tube Dysfunction Questionaire‐7 symptom scores, positive Valsalva maneuver, mucosal inflammation, and safety.
Results
Primary efficacy results demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone. Tympanogram normalization at 6‐week follow‐up was observed in 51.8% (72/139) of investigational patients versus 13.9% (10/72) of controls (P |
| doi_str_mv | 10.1002/lary.26827 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1942709152</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2027589143</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3937-84edbe807d83435c437c4c024c1146444046c207997c2b578fe027c0d15db0c43</originalsourceid><addsrcrecordid>eNp90MtKAzEUBuAgitbqxgeQgBsRRnNtJu5q8QYFQRR0FTJJBkfSiSYzSH16U6e6cOHqHDgfP4cfgAOMTjFC5MzruDwlk5KIDTDCnOKCSck3wSgfaVFy8rQDdlN6RQgLytE22CGlZIgLNgLqQnsfQgtt43XX5CXUsHtx0PWp0-al0S3s-srBOsTBhLiEdpnqvjUrfw6nMOrWhkXz6Sw0oe1i8D6vXWy03wNbtfbJ7a_nGDxeXT7Mbor53fXtbDovDJVUFCVztnIlErakjHLDqDDMIMIMxmzCGENsYggSUgpDKi7K2iEiDLKY2wplPgbHQ-5bDO-9S51aNMk473XrQp8UlowIJDEnmR79oa-hj23-TpEcykuJGc3qZFAmhpSiq9VbbBa5aYWRWtWuVrWr79ozPlxH9tXC2V_603MGeAAfjXfLf6LUfHr_PIR-AXDFjJc</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2027589143</pqid></control><display><type>article</type><title>Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial</title><source>Access via Wiley Online Library</source><creator>Poe, Dennis ; Anand, Vijay ; Dean, Marc ; Roberts, William H. ; Stolovitzky, Jose Pablo ; Hoffmann, Karen ; Nachlas, Nathan E. ; Light, Joshua P. ; Widick, Mark H. ; Sugrue, John P. ; Elliott, C. Layton ; Rosenberg, Seth I. ; Guillory, Paul ; Brown, Neil ; Syms, Charles A. ; Hilton, Christopher W. ; McElveen, John T. ; Singh, Ameet ; Weiss, Raymond L. ; Arriaga, Moises A. ; Leopold, John P.</creator><creatorcontrib>Poe, Dennis ; Anand, Vijay ; Dean, Marc ; Roberts, William H. ; Stolovitzky, Jose Pablo ; Hoffmann, Karen ; Nachlas, Nathan E. ; Light, Joshua P. ; Widick, Mark H. ; Sugrue, John P. ; Elliott, C. Layton ; Rosenberg, Seth I. ; Guillory, Paul ; Brown, Neil ; Syms, Charles A. ; Hilton, Christopher W. ; McElveen, John T. ; Singh, Ameet ; Weiss, Raymond L. ; Arriaga, Moises A. ; Leopold, John P.</creatorcontrib><description>Objectives/Hypothesis
To assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dilatory dysfunction.
Study Design
In this prospective, multicenter, randomized, controlled trial, we assigned, in a 2:1 ratio, patients age 22 years and older with Eustachian tube dilatory dysfunction refractory to medical therapy to undergo balloon dilation of the Eustachian tube with balloon catheter in conjunction with medical management or medical management alone.
Methods
The primary endpoint was normalization of tympanogram at 6 weeks. Additional endpoints were normalization of Eustachian Tube Dysfunction Questionaire‐7 symptom scores, positive Valsalva maneuver, mucosal inflammation, and safety.
Results
Primary efficacy results demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone. Tympanogram normalization at 6‐week follow‐up was observed in 51.8% (72/139) of investigational patients versus 13.9% (10/72) of controls (P < .0001). Tympanogram normalization in the treatment group was 62.2% after 24 weeks. Normalization of Eustachian Tube Dysfunction Questionaire‐7 Symptom scores at 6‐week follow‐up was observed in 56.2% (77/137) of investigational patients versus 8.5% (6/71) controls (P < .001). The investigational group also demonstrated substantial improvement in both mucosal inflammation and Valsalva maneuver at 6‐week follow‐up compared to controls. No device‐ or procedure‐related serious adverse events were reported for those who underwent balloon dilation of the Eustachian tube.
Conclusions
This study demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone to treat Eustachian tube dilatory dysfunction in adults.
Level of Evidence
1b. Laryngoscope, 128:1200–1206, 2018</description><identifier>ISSN: 0023-852X</identifier><identifier>EISSN: 1531-4995</identifier><identifier>DOI: 10.1002/lary.26827</identifier><identifier>PMID: 28940574</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>balloon catheter ; Catheters ; Eustachian tube dysfunction ; normalization of tympanogram</subject><ispartof>The Laryngoscope, 2018-05, Vol.128 (5), p.1200-1206</ispartof><rights>2017 The American Laryngological, Rhinological and Otological Society, Inc.</rights><rights>2018 The American Laryngological, Rhinological and Otological Society, Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3937-84edbe807d83435c437c4c024c1146444046c207997c2b578fe027c0d15db0c43</citedby><cites>FETCH-LOGICAL-c3937-84edbe807d83435c437c4c024c1146444046c207997c2b578fe027c0d15db0c43</cites><orcidid>0000-0002-8641-7370</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Flary.26827$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Flary.26827$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,781,785,1418,27929,27930,45579,45580</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28940574$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Poe, Dennis</creatorcontrib><creatorcontrib>Anand, Vijay</creatorcontrib><creatorcontrib>Dean, Marc</creatorcontrib><creatorcontrib>Roberts, William H.</creatorcontrib><creatorcontrib>Stolovitzky, Jose Pablo</creatorcontrib><creatorcontrib>Hoffmann, Karen</creatorcontrib><creatorcontrib>Nachlas, Nathan E.</creatorcontrib><creatorcontrib>Light, Joshua P.</creatorcontrib><creatorcontrib>Widick, Mark H.</creatorcontrib><creatorcontrib>Sugrue, John P.</creatorcontrib><creatorcontrib>Elliott, C. Layton</creatorcontrib><creatorcontrib>Rosenberg, Seth I.</creatorcontrib><creatorcontrib>Guillory, Paul</creatorcontrib><creatorcontrib>Brown, Neil</creatorcontrib><creatorcontrib>Syms, Charles A.</creatorcontrib><creatorcontrib>Hilton, Christopher W.</creatorcontrib><creatorcontrib>McElveen, John T.</creatorcontrib><creatorcontrib>Singh, Ameet</creatorcontrib><creatorcontrib>Weiss, Raymond L.</creatorcontrib><creatorcontrib>Arriaga, Moises A.</creatorcontrib><creatorcontrib>Leopold, John P.</creatorcontrib><title>Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial</title><title>The Laryngoscope</title><addtitle>Laryngoscope</addtitle><description>Objectives/Hypothesis
To assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dilatory dysfunction.
Study Design
In this prospective, multicenter, randomized, controlled trial, we assigned, in a 2:1 ratio, patients age 22 years and older with Eustachian tube dilatory dysfunction refractory to medical therapy to undergo balloon dilation of the Eustachian tube with balloon catheter in conjunction with medical management or medical management alone.
Methods
The primary endpoint was normalization of tympanogram at 6 weeks. Additional endpoints were normalization of Eustachian Tube Dysfunction Questionaire‐7 symptom scores, positive Valsalva maneuver, mucosal inflammation, and safety.
Results
Primary efficacy results demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone. Tympanogram normalization at 6‐week follow‐up was observed in 51.8% (72/139) of investigational patients versus 13.9% (10/72) of controls (P < .0001). Tympanogram normalization in the treatment group was 62.2% after 24 weeks. Normalization of Eustachian Tube Dysfunction Questionaire‐7 Symptom scores at 6‐week follow‐up was observed in 56.2% (77/137) of investigational patients versus 8.5% (6/71) controls (P < .001). The investigational group also demonstrated substantial improvement in both mucosal inflammation and Valsalva maneuver at 6‐week follow‐up compared to controls. No device‐ or procedure‐related serious adverse events were reported for those who underwent balloon dilation of the Eustachian tube.
Conclusions
This study demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone to treat Eustachian tube dilatory dysfunction in adults.
Level of Evidence
1b. Laryngoscope, 128:1200–1206, 2018</description><subject>balloon catheter</subject><subject>Catheters</subject><subject>Eustachian tube dysfunction</subject><subject>normalization of tympanogram</subject><issn>0023-852X</issn><issn>1531-4995</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><recordid>eNp90MtKAzEUBuAgitbqxgeQgBsRRnNtJu5q8QYFQRR0FTJJBkfSiSYzSH16U6e6cOHqHDgfP4cfgAOMTjFC5MzruDwlk5KIDTDCnOKCSck3wSgfaVFy8rQDdlN6RQgLytE22CGlZIgLNgLqQnsfQgtt43XX5CXUsHtx0PWp0-al0S3s-srBOsTBhLiEdpnqvjUrfw6nMOrWhkXz6Sw0oe1i8D6vXWy03wNbtfbJ7a_nGDxeXT7Mbor53fXtbDovDJVUFCVztnIlErakjHLDqDDMIMIMxmzCGENsYggSUgpDKi7K2iEiDLKY2wplPgbHQ-5bDO-9S51aNMk473XrQp8UlowIJDEnmR79oa-hj23-TpEcykuJGc3qZFAmhpSiq9VbbBa5aYWRWtWuVrWr79ozPlxH9tXC2V_603MGeAAfjXfLf6LUfHr_PIR-AXDFjJc</recordid><startdate>201805</startdate><enddate>201805</enddate><creator>Poe, Dennis</creator><creator>Anand, Vijay</creator><creator>Dean, Marc</creator><creator>Roberts, William H.</creator><creator>Stolovitzky, Jose Pablo</creator><creator>Hoffmann, Karen</creator><creator>Nachlas, Nathan E.</creator><creator>Light, Joshua P.</creator><creator>Widick, Mark H.</creator><creator>Sugrue, John P.</creator><creator>Elliott, C. Layton</creator><creator>Rosenberg, Seth I.</creator><creator>Guillory, Paul</creator><creator>Brown, Neil</creator><creator>Syms, Charles A.</creator><creator>Hilton, Christopher W.</creator><creator>McElveen, John T.</creator><creator>Singh, Ameet</creator><creator>Weiss, Raymond L.</creator><creator>Arriaga, Moises A.</creator><creator>Leopold, John P.</creator><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-8641-7370</orcidid></search><sort><creationdate>201805</creationdate><title>Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial</title><author>Poe, Dennis ; Anand, Vijay ; Dean, Marc ; Roberts, William H. ; Stolovitzky, Jose Pablo ; Hoffmann, Karen ; Nachlas, Nathan E. ; Light, Joshua P. ; Widick, Mark H. ; Sugrue, John P. ; Elliott, C. Layton ; Rosenberg, Seth I. ; Guillory, Paul ; Brown, Neil ; Syms, Charles A. ; Hilton, Christopher W. ; McElveen, John T. ; Singh, Ameet ; Weiss, Raymond L. ; Arriaga, Moises A. ; Leopold, John P.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3937-84edbe807d83435c437c4c024c1146444046c207997c2b578fe027c0d15db0c43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>balloon catheter</topic><topic>Catheters</topic><topic>Eustachian tube dysfunction</topic><topic>normalization of tympanogram</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Poe, Dennis</creatorcontrib><creatorcontrib>Anand, Vijay</creatorcontrib><creatorcontrib>Dean, Marc</creatorcontrib><creatorcontrib>Roberts, William H.</creatorcontrib><creatorcontrib>Stolovitzky, Jose Pablo</creatorcontrib><creatorcontrib>Hoffmann, Karen</creatorcontrib><creatorcontrib>Nachlas, Nathan E.</creatorcontrib><creatorcontrib>Light, Joshua P.</creatorcontrib><creatorcontrib>Widick, Mark H.</creatorcontrib><creatorcontrib>Sugrue, John P.</creatorcontrib><creatorcontrib>Elliott, C. Layton</creatorcontrib><creatorcontrib>Rosenberg, Seth I.</creatorcontrib><creatorcontrib>Guillory, Paul</creatorcontrib><creatorcontrib>Brown, Neil</creatorcontrib><creatorcontrib>Syms, Charles A.</creatorcontrib><creatorcontrib>Hilton, Christopher W.</creatorcontrib><creatorcontrib>McElveen, John T.</creatorcontrib><creatorcontrib>Singh, Ameet</creatorcontrib><creatorcontrib>Weiss, Raymond L.</creatorcontrib><creatorcontrib>Arriaga, Moises A.</creatorcontrib><creatorcontrib>Leopold, John P.</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>The Laryngoscope</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Poe, Dennis</au><au>Anand, Vijay</au><au>Dean, Marc</au><au>Roberts, William H.</au><au>Stolovitzky, Jose Pablo</au><au>Hoffmann, Karen</au><au>Nachlas, Nathan E.</au><au>Light, Joshua P.</au><au>Widick, Mark H.</au><au>Sugrue, John P.</au><au>Elliott, C. Layton</au><au>Rosenberg, Seth I.</au><au>Guillory, Paul</au><au>Brown, Neil</au><au>Syms, Charles A.</au><au>Hilton, Christopher W.</au><au>McElveen, John T.</au><au>Singh, Ameet</au><au>Weiss, Raymond L.</au><au>Arriaga, Moises A.</au><au>Leopold, John P.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial</atitle><jtitle>The Laryngoscope</jtitle><addtitle>Laryngoscope</addtitle><date>2018-05</date><risdate>2018</risdate><volume>128</volume><issue>5</issue><spage>1200</spage><epage>1206</epage><pages>1200-1206</pages><issn>0023-852X</issn><eissn>1531-4995</eissn><abstract>Objectives/Hypothesis
To assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dilatory dysfunction.
Study Design
In this prospective, multicenter, randomized, controlled trial, we assigned, in a 2:1 ratio, patients age 22 years and older with Eustachian tube dilatory dysfunction refractory to medical therapy to undergo balloon dilation of the Eustachian tube with balloon catheter in conjunction with medical management or medical management alone.
Methods
The primary endpoint was normalization of tympanogram at 6 weeks. Additional endpoints were normalization of Eustachian Tube Dysfunction Questionaire‐7 symptom scores, positive Valsalva maneuver, mucosal inflammation, and safety.
Results
Primary efficacy results demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone. Tympanogram normalization at 6‐week follow‐up was observed in 51.8% (72/139) of investigational patients versus 13.9% (10/72) of controls (P < .0001). Tympanogram normalization in the treatment group was 62.2% after 24 weeks. Normalization of Eustachian Tube Dysfunction Questionaire‐7 Symptom scores at 6‐week follow‐up was observed in 56.2% (77/137) of investigational patients versus 8.5% (6/71) controls (P < .001). The investigational group also demonstrated substantial improvement in both mucosal inflammation and Valsalva maneuver at 6‐week follow‐up compared to controls. No device‐ or procedure‐related serious adverse events were reported for those who underwent balloon dilation of the Eustachian tube.
Conclusions
This study demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone to treat Eustachian tube dilatory dysfunction in adults.
Level of Evidence
1b. Laryngoscope, 128:1200–1206, 2018</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>28940574</pmid><doi>10.1002/lary.26827</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-8641-7370</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | The Laryngoscope, 2018-05, Vol.128 (5), p.1200-1206 |
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| language | eng |
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| subjects | balloon catheter Catheters Eustachian tube dysfunction normalization of tympanogram |
| title | Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial |
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