Safety and outcomes of balloon catheter sinusotomy: A multicenter 24-week analysis in 115 patients
The aim of this study was to further evaluate the safety and effectiveness of balloon catheter devices to dilate obstructed sinus ostia/perform sinusotomy. Through a prospective, multicenter evaluation, safety was assessed by rate of adverse events, patency was determined by endoscopic examination,...
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Veröffentlicht in: | Otolaryngology-head and neck surgery 2007-07, Vol.137 (1), p.10-20 |
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container_title | Otolaryngology-head and neck surgery |
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creator | Bolger, William E. Brown, Christopher L. Church, Christopher A. Goldberg, Andrew N. Karanfilov, Boris Kuhn, Frederick A. Levine, Howard L. Sillers, Michael J. Vaughan, Winston C. Weiss, Raymond L. |
description | The aim of this study was to further evaluate the safety and effectiveness of balloon catheter devices to dilate obstructed sinus ostia/perform sinusotomy.
Through a prospective, multicenter evaluation, safety was assessed by rate of adverse events, patency was determined by endoscopic examination, and sinus symptoms were determined by the Sino-Nasal Outcome Test (SNOT 20).
At the conclusion of the 24-week analysis, endoscopy determined that the sinusotomy was patent in 80.5% (247 of 307) sinuses and nonpatent in 1.6% (5 of 307), and could not determine ostial patency status in 17.9% (55 of 307). Of the ostia visualized on endoscopy, 98% were patent (247 of 252), while 2% (5 of 252) were considered nonpatent. SNOT 20 scores showed consistent symptomatic improvement over baseline. Revision treatment was required in 3 sinuses (3 of 307 sinuses, 0.98%) in 3 patients (3 of 109 patients, 2.75%).
Balloon catheter technology appears safe and effective in relieving ostial obstruction. Patients were pleased and indicated that they experienced symptomatic improvement. |
doi_str_mv | 10.1016/j.otohns.2007.02.006 |
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Through a prospective, multicenter evaluation, safety was assessed by rate of adverse events, patency was determined by endoscopic examination, and sinus symptoms were determined by the Sino-Nasal Outcome Test (SNOT 20).
At the conclusion of the 24-week analysis, endoscopy determined that the sinusotomy was patent in 80.5% (247 of 307) sinuses and nonpatent in 1.6% (5 of 307), and could not determine ostial patency status in 17.9% (55 of 307). Of the ostia visualized on endoscopy, 98% were patent (247 of 252), while 2% (5 of 252) were considered nonpatent. SNOT 20 scores showed consistent symptomatic improvement over baseline. Revision treatment was required in 3 sinuses (3 of 307 sinuses, 0.98%) in 3 patients (3 of 109 patients, 2.75%).
Balloon catheter technology appears safe and effective in relieving ostial obstruction. Patients were pleased and indicated that they experienced symptomatic improvement.</description><identifier>ISSN: 0194-5998</identifier><identifier>EISSN: 1097-6817</identifier><identifier>DOI: 10.1016/j.otohns.2007.02.006</identifier><identifier>PMID: 17599558</identifier><language>eng</language><publisher>Los Angeles, CA: Mosby, Inc</publisher><subject>Adult ; Aged ; Catheterization - adverse effects ; Catheterization - instrumentation ; Cohort Studies ; Endoscopy ; Equipment Failure ; Female ; Fluoroscopy ; Follow-Up Studies ; Frontal Sinusitis - surgery ; Frontal Sinusitis - therapy ; Humans ; Male ; Maxillary Sinusitis - surgery ; Maxillary Sinusitis - therapy ; Middle Aged ; Prospective Studies ; Recurrence ; Retreatment ; Safety ; Sinusitis - surgery ; Sinusitis - therapy ; Sphenoid Sinusitis - surgery ; Sphenoid Sinusitis - therapy ; Tomography, X-Ray Computed ; Treatment Outcome</subject><ispartof>Otolaryngology-head and neck surgery, 2007-07, Vol.137 (1), p.10-20</ispartof><rights>2007 American Academy of Otolaryngology–Head and Neck Surgery Foundation</rights><rights>2007 SAGE Publications</rights><rights>2007 American Association of Otolaryngology‐Head and Neck Surgery Foundation (AAO‐HNSF)</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5214-f2d8197f48dd12eb674e578aaaf71275c2aff336c6f0b7dbed7541c457b854df3</citedby><cites>FETCH-LOGICAL-c5214-f2d8197f48dd12eb674e578aaaf71275c2aff336c6f0b7dbed7541c457b854df3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1016/j.otohns.2007.02.006$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1016/j.otohns.2007.02.006$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,776,780,1411,21799,27903,27904,43600,43601,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17599558$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bolger, William E.</creatorcontrib><creatorcontrib>Brown, Christopher L.</creatorcontrib><creatorcontrib>Church, Christopher A.</creatorcontrib><creatorcontrib>Goldberg, Andrew N.</creatorcontrib><creatorcontrib>Karanfilov, Boris</creatorcontrib><creatorcontrib>Kuhn, Frederick A.</creatorcontrib><creatorcontrib>Levine, Howard L.</creatorcontrib><creatorcontrib>Sillers, Michael J.</creatorcontrib><creatorcontrib>Vaughan, Winston C.</creatorcontrib><creatorcontrib>Weiss, Raymond L.</creatorcontrib><title>Safety and outcomes of balloon catheter sinusotomy: A multicenter 24-week analysis in 115 patients</title><title>Otolaryngology-head and neck surgery</title><addtitle>Otolaryngol Head Neck Surg</addtitle><description>The aim of this study was to further evaluate the safety and effectiveness of balloon catheter devices to dilate obstructed sinus ostia/perform sinusotomy.
Through a prospective, multicenter evaluation, safety was assessed by rate of adverse events, patency was determined by endoscopic examination, and sinus symptoms were determined by the Sino-Nasal Outcome Test (SNOT 20).
At the conclusion of the 24-week analysis, endoscopy determined that the sinusotomy was patent in 80.5% (247 of 307) sinuses and nonpatent in 1.6% (5 of 307), and could not determine ostial patency status in 17.9% (55 of 307). Of the ostia visualized on endoscopy, 98% were patent (247 of 252), while 2% (5 of 252) were considered nonpatent. SNOT 20 scores showed consistent symptomatic improvement over baseline. Revision treatment was required in 3 sinuses (3 of 307 sinuses, 0.98%) in 3 patients (3 of 109 patients, 2.75%).
Balloon catheter technology appears safe and effective in relieving ostial obstruction. Patients were pleased and indicated that they experienced symptomatic improvement.</description><subject>Adult</subject><subject>Aged</subject><subject>Catheterization - adverse effects</subject><subject>Catheterization - instrumentation</subject><subject>Cohort Studies</subject><subject>Endoscopy</subject><subject>Equipment Failure</subject><subject>Female</subject><subject>Fluoroscopy</subject><subject>Follow-Up Studies</subject><subject>Frontal Sinusitis - surgery</subject><subject>Frontal Sinusitis - therapy</subject><subject>Humans</subject><subject>Male</subject><subject>Maxillary Sinusitis - surgery</subject><subject>Maxillary Sinusitis - therapy</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Recurrence</subject><subject>Retreatment</subject><subject>Safety</subject><subject>Sinusitis - surgery</subject><subject>Sinusitis - therapy</subject><subject>Sphenoid Sinusitis - surgery</subject><subject>Sphenoid Sinusitis - therapy</subject><subject>Tomography, X-Ray Computed</subject><subject>Treatment Outcome</subject><issn>0194-5998</issn><issn>1097-6817</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkMFu1DAURS1ERYeWP0DIK3YJtseOHYSQ2opSpKpdFNaWYz9TD0k8xA5V_h6PMhI7YGXp-dz7ng5CrympKaHNu10dc3wcU80IkTVhNSHNM7ShpJVVo6h8jjaEtrwSbatO0cuUdqQQjZQv0CmVZSqE2qDuwXjICzajw3HONg6QcPS4M30f44ityY-QYcIpjHMqG4flPb7Aw9znYGE8_DBePQH8KBWmX1JIOIyYUoH3JodCpHN04k2f4NXxPUPfrj99vbqpbu8_f7m6uK2sYJRXnjlFW-m5co4y6BrJQUhljPGSMiksM95vt41tPOmk68BJwanlQnZKcOe3Z-jt2ruf4s8ZUtZDSBb63owQ56QlKVo4bwvIV9BOMaUJvN5PYTDToinRB7d6p1e3-uBWE6aLuRJ7c-yfuwHcn9BRZgE-rMBT6GH5r1J9f3N3ec2IUrzE6RpP5jvoXZynIjT966aPawaK2F8BJp1skW7BhQls1i6Gvxf8BkBCsII</recordid><startdate>200707</startdate><enddate>200707</enddate><creator>Bolger, William E.</creator><creator>Brown, Christopher L.</creator><creator>Church, Christopher A.</creator><creator>Goldberg, Andrew N.</creator><creator>Karanfilov, Boris</creator><creator>Kuhn, Frederick A.</creator><creator>Levine, Howard L.</creator><creator>Sillers, Michael J.</creator><creator>Vaughan, Winston C.</creator><creator>Weiss, Raymond L.</creator><general>Mosby, Inc</general><general>SAGE Publications</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>8BM</scope></search><sort><creationdate>200707</creationdate><title>Safety and outcomes of balloon catheter sinusotomy: A multicenter 24-week analysis in 115 patients</title><author>Bolger, William E. ; Brown, Christopher L. ; Church, Christopher A. ; Goldberg, Andrew N. ; Karanfilov, Boris ; Kuhn, Frederick A. ; Levine, Howard L. ; Sillers, Michael J. ; Vaughan, Winston C. ; Weiss, Raymond L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5214-f2d8197f48dd12eb674e578aaaf71275c2aff336c6f0b7dbed7541c457b854df3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Catheterization - adverse effects</topic><topic>Catheterization - instrumentation</topic><topic>Cohort Studies</topic><topic>Endoscopy</topic><topic>Equipment Failure</topic><topic>Female</topic><topic>Fluoroscopy</topic><topic>Follow-Up Studies</topic><topic>Frontal Sinusitis - surgery</topic><topic>Frontal Sinusitis - therapy</topic><topic>Humans</topic><topic>Male</topic><topic>Maxillary Sinusitis - surgery</topic><topic>Maxillary Sinusitis - therapy</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Recurrence</topic><topic>Retreatment</topic><topic>Safety</topic><topic>Sinusitis - surgery</topic><topic>Sinusitis - therapy</topic><topic>Sphenoid Sinusitis - surgery</topic><topic>Sphenoid Sinusitis - therapy</topic><topic>Tomography, X-Ray Computed</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bolger, William E.</creatorcontrib><creatorcontrib>Brown, Christopher L.</creatorcontrib><creatorcontrib>Church, Christopher A.</creatorcontrib><creatorcontrib>Goldberg, Andrew N.</creatorcontrib><creatorcontrib>Karanfilov, Boris</creatorcontrib><creatorcontrib>Kuhn, Frederick A.</creatorcontrib><creatorcontrib>Levine, Howard L.</creatorcontrib><creatorcontrib>Sillers, Michael J.</creatorcontrib><creatorcontrib>Vaughan, Winston C.</creatorcontrib><creatorcontrib>Weiss, Raymond L.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>ComDisDome</collection><jtitle>Otolaryngology-head and neck surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bolger, William E.</au><au>Brown, Christopher L.</au><au>Church, Christopher A.</au><au>Goldberg, Andrew N.</au><au>Karanfilov, Boris</au><au>Kuhn, Frederick A.</au><au>Levine, Howard L.</au><au>Sillers, Michael J.</au><au>Vaughan, Winston C.</au><au>Weiss, Raymond L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and outcomes of balloon catheter sinusotomy: A multicenter 24-week analysis in 115 patients</atitle><jtitle>Otolaryngology-head and neck surgery</jtitle><addtitle>Otolaryngol Head Neck Surg</addtitle><date>2007-07</date><risdate>2007</risdate><volume>137</volume><issue>1</issue><spage>10</spage><epage>20</epage><pages>10-20</pages><issn>0194-5998</issn><eissn>1097-6817</eissn><abstract>The aim of this study was to further evaluate the safety and effectiveness of balloon catheter devices to dilate obstructed sinus ostia/perform sinusotomy.
Through a prospective, multicenter evaluation, safety was assessed by rate of adverse events, patency was determined by endoscopic examination, and sinus symptoms were determined by the Sino-Nasal Outcome Test (SNOT 20).
At the conclusion of the 24-week analysis, endoscopy determined that the sinusotomy was patent in 80.5% (247 of 307) sinuses and nonpatent in 1.6% (5 of 307), and could not determine ostial patency status in 17.9% (55 of 307). Of the ostia visualized on endoscopy, 98% were patent (247 of 252), while 2% (5 of 252) were considered nonpatent. SNOT 20 scores showed consistent symptomatic improvement over baseline. Revision treatment was required in 3 sinuses (3 of 307 sinuses, 0.98%) in 3 patients (3 of 109 patients, 2.75%).
Balloon catheter technology appears safe and effective in relieving ostial obstruction. Patients were pleased and indicated that they experienced symptomatic improvement.</abstract><cop>Los Angeles, CA</cop><pub>Mosby, Inc</pub><pmid>17599558</pmid><doi>10.1016/j.otohns.2007.02.006</doi><tpages>11</tpages></addata></record> |
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source | SAGE Complete A-Z List; MEDLINE; Wiley Online Library Journals Frontfile Complete; Alma/SFX Local Collection |
subjects | Adult Aged Catheterization - adverse effects Catheterization - instrumentation Cohort Studies Endoscopy Equipment Failure Female Fluoroscopy Follow-Up Studies Frontal Sinusitis - surgery Frontal Sinusitis - therapy Humans Male Maxillary Sinusitis - surgery Maxillary Sinusitis - therapy Middle Aged Prospective Studies Recurrence Retreatment Safety Sinusitis - surgery Sinusitis - therapy Sphenoid Sinusitis - surgery Sphenoid Sinusitis - therapy Tomography, X-Ray Computed Treatment Outcome |
title | Safety and outcomes of balloon catheter sinusotomy: A multicenter 24-week analysis in 115 patients |
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