The safety and efficacy of an extravascular, water‐soluble sealant for vascular closure: Initial clinical results for Mynx™
Identifieur interne : 001727 ( Istex/Corpus ); précédent : 001726; suivant : 001728The safety and efficacy of an extravascular, water‐soluble sealant for vascular closure: Initial clinical results for Mynx™
Auteurs : D. Scheinert ; H. Sievert ; M. A. Turco ; A. Schmidt ; K. E. Hauptmann ; R. Mueller ; D. Dadourian ; H. Krankenberg ; E. GrubeSource :
- Catheterization and Cardiovascular Interventions [ 1522-1946 ] ; 2007-11-01.
English descriptors
Abstract
Objective: The purpose of this study was to evaluate the hemostatic efficacy and safety of the Mynx extravascular sealant for femoral artery closure. Background: The Mynx device is an extra‐arterial vascular closure technology utilizing a water‐soluble, porous, polyethylene glycol matrix that immediately seals the arteriotomy by rapidly absorbing subcutaneous fluids and expanding in the tissue tract and then, resorbs within 30 days. Methods: The Mynx study was a prospective, multicenter, single‐arm clinical investigation conducted at five European centers. The safety and effectiveness of the Mynx device was evaluated in patients following diagnostic or interventional endovascular procedures performed through 5 Fr, 6 Fr, or 7 Fr introducer sheaths in the common femoral artery. The primary safety endpoint was the combined rate of major complications within 30 days (±7 days). The primary efficacy endpoints were time to hemostasis and time to ambulation. Results: Patient enrollment included 190 patients with 50% having undergone diagnostic catheterization and 50% interventional procedures with a mean activated clotting time of 221 sec. One (0.5%) major vascular complication (transfusion) occurred in one patient. No device‐precipitated complications associated with serious clinical sequelae were reported. Mean (± standard deviation) times to hemostasis and ambulation were 1.3 ± 2.3 min and 2.6 ± 2.6 hr, respectively. There was no significant difference in median times to hemostasis between diagnostic and interventional patients (0.5 vs. 0.6 min). Conclusions: The initial experience with the extra‐arterial Mynx closure technology supports hemostatic safety and efficacy in patients undergoing diagnostic and interventional catheterization procedures. © 2007 Wiley‐Liss, Inc.
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DOI: 10.1002/ccd.21353
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A." last="Turco">M. A. Turco</name><affiliation><mods:affiliation>Washington Adventist Hospital, Tacoma Park, Maryland</mods:affiliation></affiliation></author><author><name sortKey="Schmidt, A" sort="Schmidt, A" uniqKey="Schmidt A" first="A." last="Schmidt">A. Schmidt</name><affiliation><mods:affiliation>Department of Angiology, Heart Center, University of Leipzig, Leipzig, Germany</mods:affiliation></affiliation></author><author><name sortKey="Hauptmann, K E" sort="Hauptmann, K E" uniqKey="Hauptmann K" first="K. E." last="Hauptmann">K. E. Hauptmann</name><affiliation><mods:affiliation>Department of Internal Medicine, Cardiology Med. Klinik I, Trier, Germany</mods:affiliation></affiliation></author><author><name sortKey="Mueller, R" sort="Mueller, R" uniqKey="Mueller R" first="R." last="Mueller">R. Mueller</name><affiliation><mods:affiliation>Department of Cardiology, HELIOS Heart Center Siegburg, Siegburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Dadourian, D" sort="Dadourian, D" uniqKey="Dadourian D" first="D." last="Dadourian">D. Dadourian</name><affiliation><mods:affiliation>Hahnemann University Hospital, Philadelphia, Pennsylvania</mods:affiliation></affiliation></author><author><name sortKey="Krankenberg, H" sort="Krankenberg, H" uniqKey="Krankenberg H" first="H." last="Krankenberg">H. Krankenberg</name><affiliation><mods:affiliation>Universitaeres Herz‐und Gefaesszentrum Hamburg GmbH, Hamburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Grube, E" sort="Grube, E" uniqKey="Grube E" first="E." last="Grube">E. 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Scheinert</name><affiliation><mods:affiliation>Department of Angiology, Heart Center, University of Leipzig, Leipzig, Germany</mods:affiliation></affiliation><affiliation><mods:affiliation>University of Leipzig, Heart Center, Leipzig, Germany</mods:affiliation></affiliation></author><author><name sortKey="Sievert, H" sort="Sievert, H" uniqKey="Sievert H" first="H." last="Sievert">H. Sievert</name><affiliation><mods:affiliation>CardioVascular Center, Frankfurt Germany and Washington Hospital Center, Washington DC</mods:affiliation></affiliation></author><author><name sortKey="Turco, M A" sort="Turco, M A" uniqKey="Turco M" first="M. A." last="Turco">M. A. Turco</name><affiliation><mods:affiliation>Washington Adventist Hospital, Tacoma Park, Maryland</mods:affiliation></affiliation></author><author><name sortKey="Schmidt, A" sort="Schmidt, A" uniqKey="Schmidt A" first="A." last="Schmidt">A. Schmidt</name><affiliation><mods:affiliation>Department of Angiology, Heart Center, University of Leipzig, Leipzig, Germany</mods:affiliation></affiliation></author><author><name sortKey="Hauptmann, K E" sort="Hauptmann, K E" uniqKey="Hauptmann K" first="K. E." last="Hauptmann">K. E. Hauptmann</name><affiliation><mods:affiliation>Department of Internal Medicine, Cardiology Med. Klinik I, Trier, Germany</mods:affiliation></affiliation></author><author><name sortKey="Mueller, R" sort="Mueller, R" uniqKey="Mueller R" first="R." last="Mueller">R. Mueller</name><affiliation><mods:affiliation>Department of Cardiology, HELIOS Heart Center Siegburg, Siegburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Dadourian, D" sort="Dadourian, D" uniqKey="Dadourian D" first="D." last="Dadourian">D. Dadourian</name><affiliation><mods:affiliation>Hahnemann University Hospital, Philadelphia, Pennsylvania</mods:affiliation></affiliation></author><author><name sortKey="Krankenberg, H" sort="Krankenberg, H" uniqKey="Krankenberg H" first="H." last="Krankenberg">H. Krankenberg</name><affiliation><mods:affiliation>Universitaeres Herz‐und Gefaesszentrum Hamburg GmbH, Hamburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Grube, E" sort="Grube, E" uniqKey="Grube E" first="E." last="Grube">E. Grube</name><affiliation><mods:affiliation>Department of Cardiology, HELIOS Heart Center Siegburg, Siegburg, Germany</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Catheterization and Cardiovascular Interventions</title><title level="j" type="abbrev">Cathet. Cardiovasc. Intervent.</title><idno type="ISSN">1522-1946</idno><idno type="eISSN">1522-726X</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2007-11-01">2007-11-01</date><biblScope unit="volume">70</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="627">627</biblScope><biblScope unit="page" to="633">633</biblScope></imprint><idno type="ISSN">1522-1946</idno></series><idno type="istex">3FE41F94C39F7106C3FAE31BF99C91E5A48EBAD8</idno><idno type="DOI">10.1002/ccd.21353</idno><idno type="ArticleID">CCD21353</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1522-1946</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>cardiac catheterization</term><term>femoral artery</term><term>hemostasis</term><term>polyethylene glycol</term><term>vascular access</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Objective: The purpose of this study was to evaluate the hemostatic efficacy and safety of the Mynx extravascular sealant for femoral artery closure. Background: The Mynx device is an extra‐arterial vascular closure technology utilizing a water‐soluble, porous, polyethylene glycol matrix that immediately seals the arteriotomy by rapidly absorbing subcutaneous fluids and expanding in the tissue tract and then, resorbs within 30 days. Methods: The Mynx study was a prospective, multicenter, single‐arm clinical investigation conducted at five European centers. The safety and effectiveness of the Mynx device was evaluated in patients following diagnostic or interventional endovascular procedures performed through 5 Fr, 6 Fr, or 7 Fr introducer sheaths in the common femoral artery. The primary safety endpoint was the combined rate of major complications within 30 days (±7 days). The primary efficacy endpoints were time to hemostasis and time to ambulation. Results: Patient enrollment included 190 patients with 50% having undergone diagnostic catheterization and 50% interventional procedures with a mean activated clotting time of 221 sec. One (0.5%) major vascular complication (transfusion) occurred in one patient. No device‐precipitated complications associated with serious clinical sequelae were reported. Mean (± standard deviation) times to hemostasis and ambulation were 1.3 ± 2.3 min and 2.6 ± 2.6 hr, respectively. There was no significant difference in median times to hemostasis between diagnostic and interventional patients (0.5 vs. 0.6 min). Conclusions: The initial experience with the extra‐arterial Mynx closure technology supports hemostatic safety and efficacy in patients undergoing diagnostic and interventional catheterization procedures. © 2007 Wiley‐Liss, Inc.</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>D. Scheinert MD</name><affiliations><json:string>Department of Angiology, Heart Center, University of Leipzig, Leipzig, Germany</json:string><json:string>University of Leipzig, Heart Center, Leipzig, Germany</json:string></affiliations></json:item><json:item><name>H. Sievert MD</name><affiliations><json:string>CardioVascular Center, Frankfurt Germany and Washington Hospital Center, Washington DC</json:string></affiliations></json:item><json:item><name>M.A. Turco MD, FACC</name><affiliations><json:string>Washington Adventist Hospital, Tacoma Park, Maryland</json:string></affiliations></json:item><json:item><name>A. Schmidt MD</name><affiliations><json:string>Department of Angiology, Heart Center, University of Leipzig, Leipzig, Germany</json:string></affiliations></json:item><json:item><name>K.E. Hauptmann MD</name><affiliations><json:string>Department of Internal Medicine, Cardiology Med. Klinik I, Trier, Germany</json:string></affiliations></json:item><json:item><name>R. Mueller MD</name><affiliations><json:string>Department of Cardiology, HELIOS Heart Center Siegburg, Siegburg, Germany</json:string></affiliations></json:item><json:item><name>D. Dadourian MD, FACC</name><affiliations><json:string>Hahnemann University Hospital, Philadelphia, Pennsylvania</json:string></affiliations></json:item><json:item><name>H. Krankenberg MD</name><affiliations><json:string>Universitaeres Herz‐und Gefaesszentrum Hamburg GmbH, Hamburg, Germany</json:string></affiliations></json:item><json:item><name>E. Grube MD, FACC</name><affiliations><json:string>Department of Cardiology, HELIOS Heart Center Siegburg, Siegburg, Germany</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>femoral artery</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>hemostasis</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>vascular access</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>polyethylene glycol</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>cardiac catheterization</value></json:item></subject><articleId><json:string>CCD21353</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>article</json:string></originalGenre><abstract>Objective: The purpose of this study was to evaluate the hemostatic efficacy and safety of the Mynx extravascular sealant for femoral artery closure. Background: The Mynx device is an extra‐arterial vascular closure technology utilizing a water‐soluble, porous, polyethylene glycol matrix that immediately seals the arteriotomy by rapidly absorbing subcutaneous fluids and expanding in the tissue tract and then, resorbs within 30 days. Methods: The Mynx study was a prospective, multicenter, single‐arm clinical investigation conducted at five European centers. The safety and effectiveness of the Mynx device was evaluated in patients following diagnostic or interventional endovascular procedures performed through 5 Fr, 6 Fr, or 7 Fr introducer sheaths in the common femoral artery. The primary safety endpoint was the combined rate of major complications within 30 days (±7 days). The primary efficacy endpoints were time to hemostasis and time to ambulation. Results: Patient enrollment included 190 patients with 50% having undergone diagnostic catheterization and 50% interventional procedures with a mean activated clotting time of 221 sec. One (0.5%) major vascular complication (transfusion) occurred in one patient. No device‐precipitated complications associated with serious clinical sequelae were reported. Mean (± standard deviation) times to hemostasis and ambulation were 1.3 ± 2.3 min and 2.6 ± 2.6 hr, respectively. There was no significant difference in median times to hemostasis between diagnostic and interventional patients (0.5 vs. 0.6 min). Conclusions: The initial experience with the extra‐arterial Mynx closure technology supports hemostatic safety and efficacy in patients undergoing diagnostic and interventional catheterization procedures. © 2007 Wiley‐Liss, Inc.</abstract><qualityIndicators><score>7.267</score><pdfVersion>1.3</pdfVersion><pdfPageSize>612 x 810 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractCharCount>1796</abstractCharCount><pdfWordCount>4267</pdfWordCount><pdfCharCount>29186</pdfCharCount><pdfPageCount>7</pdfPageCount><abstractWordCount>251</abstractWordCount></qualityIndicators><title>The safety and efficacy of an extravascular, water‐soluble sealant for vascular closure: Initial clinical results for Mynx™</title><refBibs><json:item><author><json:item><name>E Nikolsky</name></json:item><json:item><name>R Mehran</name></json:item><json:item><name>A Halkin</name></json:item><json:item><name>ED Aymong</name></json:item><json:item><name>GS 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Klinik I, Trier, Germany</affiliation></author><author xml:id="author-6"><persName><forename type="first">R.</forename><surname>Mueller</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Cardiology, HELIOS Heart Center Siegburg, Siegburg, Germany</affiliation></author><author xml:id="author-7"><persName><forename type="first">D.</forename><surname>Dadourian</surname></persName><roleName type="degree">MD, FACC</roleName><affiliation>Hahnemann University Hospital, Philadelphia, Pennsylvania</affiliation></author><author xml:id="author-8"><persName><forename type="first">H.</forename><surname>Krankenberg</surname></persName><roleName type="degree">MD</roleName><affiliation>Universitaeres Herz‐und Gefaesszentrum Hamburg GmbH, Hamburg, Germany</affiliation></author><author xml:id="author-9"><persName><forename type="first">E.</forename><surname>Grube</surname></persName><roleName type="degree">MD, FACC</roleName><affiliation>Department of Cardiology, HELIOS Heart Center Siegburg, Siegburg, Germany</affiliation></author></analytic><monogr><title level="j">Catheterization and Cardiovascular Interventions</title><title level="j" type="abbrev">Cathet. Cardiovasc. Intervent.</title><idno type="pISSN">1522-1946</idno><idno type="eISSN">1522-726X</idno><idno type="DOI">10.1002/(ISSN)1522-726X</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2007-11-01"></date><biblScope unit="volume">70</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="627">627</biblScope><biblScope unit="page" to="633">633</biblScope></imprint></monogr><idno type="istex">3FE41F94C39F7106C3FAE31BF99C91E5A48EBAD8</idno><idno type="DOI">10.1002/ccd.21353</idno><idno type="ArticleID">CCD21353</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2007</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Objective: The purpose of this study was to evaluate the hemostatic efficacy and safety of the Mynx extravascular sealant for femoral artery closure. Background: The Mynx device is an extra‐arterial vascular closure technology utilizing a water‐soluble, porous, polyethylene glycol matrix that immediately seals the arteriotomy by rapidly absorbing subcutaneous fluids and expanding in the tissue tract and then, resorbs within 30 days. Methods: The Mynx study was a prospective, multicenter, single‐arm clinical investigation conducted at five European centers. The safety and effectiveness of the Mynx device was evaluated in patients following diagnostic or interventional endovascular procedures performed through 5 Fr, 6 Fr, or 7 Fr introducer sheaths in the common femoral artery. The primary safety endpoint was the combined rate of major complications within 30 days (±7 days). The primary efficacy endpoints were time to hemostasis and time to ambulation. Results: Patient enrollment included 190 patients with 50% having undergone diagnostic catheterization and 50% interventional procedures with a mean activated clotting time of 221 sec. One (0.5%) major vascular complication (transfusion) occurred in one patient. No device‐precipitated complications associated with serious clinical sequelae were reported. Mean (± standard deviation) times to hemostasis and ambulation were 1.3 ± 2.3 min and 2.6 ± 2.6 hr, respectively. There was no significant difference in median times to hemostasis between diagnostic and interventional patients (0.5 vs. 0.6 min). Conclusions: The initial experience with the extra‐arterial Mynx closure technology supports hemostatic safety and efficacy in patients undergoing diagnostic and interventional catheterization procedures. © 2007 Wiley‐Liss, Inc.</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>keywords</head><item><term>femoral artery</term></item><item><term>hemostasis</term></item><item><term>vascular access</term></item><item><term>polyethylene glycol</term></item><item><term>cardiac catheterization</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article-category</head><item><term>Coronary Artery Disease</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2007-04-25">Received</change><change when="2007-08-01">Registration</change><change when="2007-11-01">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/3FE41F94C39F7106C3FAE31BF99C91E5A48EBAD8/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Hoboken</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1522-726X</doi><issn type="print">1522-1946</issn><issn type="electronic">1522-726X</issn><idGroup><id type="product" value="CCD"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS">Catheterization and Cardiovascular Interventions</title><title type="short">Cathet. Cardiovasc. Intervent.</title></titleGroup><selfCitationGroup><citation type="ancestor" xml:id="cit1"><journalTitle>Catheterization and Cardiovascular Diagnosis</journalTitle><accessionId ref="info:x-wiley/issn/00986569">0098-6569</accessionId><accessionId ref="info:x-wiley/issn/10970304">1097-0304</accessionId><pubYear year="1998">1998</pubYear><vol>45</vol><issue>4</issue></citation></selfCitationGroup></publicationMeta><publicationMeta level="part" position="50"><doi origin="wiley" registered="yes">10.1002/ccd.v70:5</doi><numberingGroup><numbering type="journalVolume" number="70">70</numbering><numbering type="journalIssue">5</numbering></numberingGroup><coverDate startDate="2007-11-01">1 November 2007</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="1" status="forIssue"><doi origin="wiley" registered="yes">10.1002/ccd.21353</doi><idGroup><id type="unit" value="CCD21353"></id></idGroup><countGroup><count type="pageTotal" number="7"></count></countGroup><titleGroup><title type="articleCategory">Coronary Artery Disease</title><title type="tocHeading1">Coronary Artery Disease</title><title type="tocHeading2">Original Studies</title></titleGroup><copyright ownership="publisher">Copyright © 2007 Wiley‐Liss, Inc.</copyright><eventGroup><event type="manuscriptReceived" date="2007-04-25"></event><event type="manuscriptAccepted" date="2007-08-01"></event><event type="firstOnline" date="2007-10-24"></event><event type="publishedOnlineFinalForm" date="2007-10-29"></event><event type="xmlConverted" agent="Converter:JWSART34_TO_WML3G version:2.3.15 mode:FullText" date="2010-07-21"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.8.8" date="2014-01-09"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.1.7 mode:FullText,remove_FC" date="2014-10-15"></event></eventGroup><numberingGroup><numbering type="pageFirst">627</numbering><numbering type="pageLast">633</numbering></numberingGroup><correspondenceTo>University of Leipzig, Heart Center, Leipzig, Germany</correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:CCD.CCD21353.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="1"></count><count type="tableTotal" number="3"></count><count type="referenceTotal" number="12"></count><count type="wordTotal" number="5243"></count></countGroup><titleGroup><title type="main" xml:lang="en">The safety and efficacy of an extravascular, water‐soluble sealant for vascular closure: Initial clinical results for Mynx™</title><title type="short" xml:lang="en">Extravascular Sealant for Vascular Closure</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>D.</givenNames><familyName>Scheinert</familyName><degrees>MD</degrees></personName><contactDetails><email normalForm="sched@medizin.uni-leipzig.de">sched@medizin.uni‐leipzig.de</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>H.</givenNames><familyName>Sievert</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>M.A.</givenNames><familyName>Turco</familyName><degrees>MD, FACC</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af1"><personName><givenNames>A.</givenNames><familyName>Schmidt</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af4"><personName><givenNames>K.E.</givenNames><familyName>Hauptmann</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af5"><personName><givenNames>R.</givenNames><familyName>Mueller</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au7" creatorRole="author" affiliationRef="#af6"><personName><givenNames>D.</givenNames><familyName>Dadourian</familyName><degrees>MD, FACC</degrees></personName></creator><creator xml:id="au8" creatorRole="author" affiliationRef="#af7"><personName><givenNames>H.</givenNames><familyName>Krankenberg</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au9" creatorRole="author" affiliationRef="#af5"><personName><givenNames>E.</givenNames><familyName>Grube</familyName><degrees>MD, FACC</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="DE" type="organization"><unparsedAffiliation>Department of Angiology, Heart Center, University of Leipzig, Leipzig, Germany</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="US" type="organization"><unparsedAffiliation>CardioVascular Center, Frankfurt Germany and Washington Hospital Center, Washington DC</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="US" type="organization"><unparsedAffiliation>Washington Adventist Hospital, Tacoma Park, Maryland</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="DE" type="organization"><unparsedAffiliation>Department of Internal Medicine, Cardiology Med. Klinik I, Trier, Germany</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="DE" type="organization"><unparsedAffiliation>Department of Cardiology, HELIOS Heart Center Siegburg, Siegburg, Germany</unparsedAffiliation></affiliation><affiliation xml:id="af6" countryCode="US" type="organization"><unparsedAffiliation>Hahnemann University Hospital, Philadelphia, Pennsylvania</unparsedAffiliation></affiliation><affiliation xml:id="af7" countryCode="DE" type="organization"><unparsedAffiliation>Universitaeres Herz‐und Gefaesszentrum Hamburg GmbH, Hamburg, Germany</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">femoral artery</keyword><keyword xml:id="kwd2">hemostasis</keyword><keyword xml:id="kwd3">vascular access</keyword><keyword xml:id="kwd4">polyethylene glycol</keyword><keyword xml:id="kwd5">cardiac catheterization</keyword></keywordGroup><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p><span cssStyle="text-decoration:underline">Objective:</span> The purpose of this study was to evaluate the hemostatic efficacy and safety of the Mynx extravascular sealant for femoral artery closure. <span cssStyle="text-decoration:underline">Background:</span> The Mynx device is an extra‐arterial vascular closure technology utilizing a water‐soluble, porous, polyethylene glycol matrix that immediately seals the arteriotomy by rapidly absorbing subcutaneous fluids and expanding in the tissue tract and then, resorbs within 30 days. <span cssStyle="text-decoration:underline">Methods:</span> The Mynx study was a prospective, multicenter, single‐arm clinical investigation conducted at five European centers. The safety and effectiveness of the Mynx device was evaluated in patients following diagnostic or interventional endovascular procedures performed through 5 Fr, 6 Fr, or 7 Fr introducer sheaths in the common femoral artery. The primary safety endpoint was the combined rate of major complications within 30 days (±7 days). The primary efficacy endpoints were time to hemostasis and time to ambulation. <span cssStyle="text-decoration:underline">Results:</span> Patient enrollment included 190 patients with 50% having undergone diagnostic catheterization and 50% interventional procedures with a mean activated clotting time of 221 sec. One (0.5%) major vascular complication (transfusion) occurred in one patient. No device‐precipitated complications associated with serious clinical sequelae were reported. Mean (± standard deviation) times to hemostasis and ambulation were 1.3 ± 2.3 min and 2.6 ± 2.6 hr, respectively. There was no significant difference in median times to hemostasis between diagnostic and interventional patients (0.5 vs. 0.6 min). <span cssStyle="text-decoration:underline">Conclusions:</span> The initial experience with the extra‐arterial Mynx closure technology supports hemostatic safety and efficacy in patients undergoing diagnostic and interventional catheterization procedures. © 2007 Wiley‐Liss, Inc.</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>The safety and efficacy of an extravascular, water‐soluble sealant for vascular closure: Initial clinical results for Mynx™</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Extravascular Sealant for Vascular Closure</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>The safety and efficacy of an extravascular, water‐soluble sealant for vascular closure: Initial clinical results for Mynx™</title></titleInfo><name type="personal"><namePart type="given">D.</namePart><namePart type="family">Scheinert</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Angiology, Heart Center, University of Leipzig, Leipzig, Germany</affiliation><affiliation>University of Leipzig, Heart Center, Leipzig, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Sievert</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>CardioVascular Center, Frankfurt Germany and Washington Hospital Center, Washington DC</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.A.</namePart><namePart type="family">Turco</namePart><namePart type="termsOfAddress">MD, FACC</namePart><affiliation>Washington Adventist Hospital, Tacoma Park, Maryland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A.</namePart><namePart type="family">Schmidt</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Angiology, Heart Center, University of Leipzig, Leipzig, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">K.E.</namePart><namePart type="family">Hauptmann</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Internal Medicine, Cardiology Med. Klinik I, Trier, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R.</namePart><namePart type="family">Mueller</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Cardiology, HELIOS Heart Center Siegburg, Siegburg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">D.</namePart><namePart type="family">Dadourian</namePart><namePart type="termsOfAddress">MD, FACC</namePart><affiliation>Hahnemann University Hospital, Philadelphia, Pennsylvania</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Krankenberg</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Universitaeres Herz‐und Gefaesszentrum Hamburg GmbH, Hamburg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">E.</namePart><namePart type="family">Grube</namePart><namePart type="termsOfAddress">MD, FACC</namePart><affiliation>Department of Cardiology, HELIOS Heart Center Siegburg, Siegburg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2007-11-01</dateIssued><dateCaptured encoding="w3cdtf">2007-04-25</dateCaptured><dateValid encoding="w3cdtf">2007-08-01</dateValid><copyrightDate encoding="w3cdtf">2007</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="figures">1</extent><extent unit="tables">3</extent><extent unit="references">12</extent><extent unit="words">5243</extent></physicalDescription><abstract lang="en">Objective: The purpose of this study was to evaluate the hemostatic efficacy and safety of the Mynx extravascular sealant for femoral artery closure. Background: The Mynx device is an extra‐arterial vascular closure technology utilizing a water‐soluble, porous, polyethylene glycol matrix that immediately seals the arteriotomy by rapidly absorbing subcutaneous fluids and expanding in the tissue tract and then, resorbs within 30 days. Methods: The Mynx study was a prospective, multicenter, single‐arm clinical investigation conducted at five European centers. The safety and effectiveness of the Mynx device was evaluated in patients following diagnostic or interventional endovascular procedures performed through 5 Fr, 6 Fr, or 7 Fr introducer sheaths in the common femoral artery. The primary safety endpoint was the combined rate of major complications within 30 days (±7 days). The primary efficacy endpoints were time to hemostasis and time to ambulation. Results: Patient enrollment included 190 patients with 50% having undergone diagnostic catheterization and 50% interventional procedures with a mean activated clotting time of 221 sec. One (0.5%) major vascular complication (transfusion) occurred in one patient. No device‐precipitated complications associated with serious clinical sequelae were reported. Mean (± standard deviation) times to hemostasis and ambulation were 1.3 ± 2.3 min and 2.6 ± 2.6 hr, respectively. There was no significant difference in median times to hemostasis between diagnostic and interventional patients (0.5 vs. 0.6 min). Conclusions: The initial experience with the extra‐arterial Mynx closure technology supports hemostatic safety and efficacy in patients undergoing diagnostic and interventional catheterization procedures. © 2007 Wiley‐Liss, Inc.</abstract><subject lang="en"><genre>keywords</genre><topic>femoral artery</topic><topic>hemostasis</topic><topic>vascular access</topic><topic>polyethylene glycol</topic><topic>cardiac catheterization</topic></subject><relatedItem type="host"><titleInfo><title>Catheterization and Cardiovascular Interventions</title></titleInfo><titleInfo type="abbreviated"><title>Cathet. Cardiovasc. Intervent.</title></titleInfo><genre type="journal">journal</genre><subject><genre>article-category</genre><topic>Coronary Artery Disease</topic></subject><identifier type="ISSN">1522-1946</identifier><identifier type="eISSN">1522-726X</identifier><identifier type="DOI">10.1002/(ISSN)1522-726X</identifier><identifier type="PublisherID">CCD</identifier><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>70</number></detail><detail type="issue"><caption>no.</caption><number>5</number></detail><extent unit="pages"><start>627</start><end>633</end><total>7</total></extent></part></relatedItem><relatedItem type="preceding"><titleInfo><title>Catheterization and Cardiovascular Diagnosis</title></titleInfo><identifier type="ISSN">0098-6569</identifier><identifier type="ISSN">1097-0304</identifier><part><date point="end">1998</date><detail type="volume"><caption>last vol.</caption><number>45</number></detail><detail type="issue"><caption>last no.</caption><number>4</number></detail></part></relatedItem><identifier type="istex">3FE41F94C39F7106C3FAE31BF99C91E5A48EBAD8</identifier><identifier type="DOI">10.1002/ccd.21353</identifier><identifier type="ArticleID">CCD21353</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2007 Wiley‐Liss, Inc.</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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