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Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve.

Identifieur interne : 000635 ( Ncbi/Merge ); précédent : 000634; suivant : 000636

Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve.

Auteurs : Joachim Schofer [Allemagne] ; Antonio Colombo [Italie] ; Silvio Klugmann [Italie] ; Jean Fajadet [France] ; Federico Demarco [Italie] ; Didier Tchétché [France] ; Francesco Maisano [Italie] ; Giuseppe Bruschi [Italie] ; Azeem Latib [Italie] ; Klaudija Bijuklic [Allemagne] ; Neil Weissman [États-Unis] ; Reginald Low [Royaume-Uni] ; Martyn Thomas [Royaume-Uni] ; Christopher Young [Royaume-Uni] ; Simon Redwood [Royaume-Uni] ; Michael Mullen [Allemagne] ; John Yap [Allemagne] ; Eberhard Grube [Allemagne] ; Georg Nickenig [Allemagne] ; Jan-Malte Sinning [Allemagne] ; Karl Eugen Hauptmann [Allemagne] ; Ivar Friedrich [Allemagne] ; Michael Lauterbach [Allemagne] ; Michael Schmoeckel [États-Unis] ; Charles Davidson [France] ; Thierry Lefevre [États-Unis]

Source :

RBID : pubmed:24211506

English descriptors

Abstract

The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical (DFM) system for the treatment of severe aortic stenosis.

DOI: 10.1016/j.jacc.2013.10.013
PubMed: 24211506

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pubmed:24211506

Le document en format XML

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<name sortKey="Mullen, Michael" sort="Mullen, Michael" uniqKey="Mullen M" first="Michael" last="Mullen">Michael Mullen</name>
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<name sortKey="Yap, John" sort="Yap, John" uniqKey="Yap J" first="John" last="Yap">John Yap</name>
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<name sortKey="Grube, Eberhard" sort="Grube, Eberhard" uniqKey="Grube E" first="Eberhard" last="Grube">Eberhard Grube</name>
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<name sortKey="Sinning, Jan Malte" sort="Sinning, Jan Malte" uniqKey="Sinning J" first="Jan-Malte" last="Sinning">Jan-Malte Sinning</name>
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<name sortKey="Hauptmann, Karl Eugen" sort="Hauptmann, Karl Eugen" uniqKey="Hauptmann K" first="Karl Eugen" last="Hauptmann">Karl Eugen Hauptmann</name>
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<name sortKey="Friedrich, Ivar" sort="Friedrich, Ivar" uniqKey="Friedrich I" first="Ivar" last="Friedrich">Ivar Friedrich</name>
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<name sortKey="Davidson, Charles" sort="Davidson, Charles" uniqKey="Davidson C" first="Charles" last="Davidson">Charles Davidson</name>
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<name sortKey="Lefevre, Thierry" sort="Lefevre, Thierry" uniqKey="Lefevre T" first="Thierry" last="Lefevre">Thierry Lefevre</name>
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<name sortKey="Bruschi, Giuseppe" sort="Bruschi, Giuseppe" uniqKey="Bruschi G" first="Giuseppe" last="Bruschi">Giuseppe Bruschi</name>
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<name sortKey="Bijuklic, Klaudija" sort="Bijuklic, Klaudija" uniqKey="Bijuklic K" first="Klaudija" last="Bijuklic">Klaudija Bijuklic</name>
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<name sortKey="Nickenig, Georg" sort="Nickenig, Georg" uniqKey="Nickenig G" first="Georg" last="Nickenig">Georg Nickenig</name>
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<region type="state">Illinois</region>
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<name sortKey="Davidson, Charles" sort="Davidson, Charles" uniqKey="Davidson C" first="Charles" last="Davidson">Charles Davidson</name>
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<name sortKey="Lefevre, Thierry" sort="Lefevre, Thierry" uniqKey="Lefevre T" first="Thierry" last="Lefevre">Thierry Lefevre</name>
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<region type="state">Californie</region>
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<title level="j">Journal of the American College of Cardiology</title>
<idno type="eISSN">1558-3597</idno>
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<term>Aortic Valve (surgery)</term>
<term>Aortic Valve Stenosis (diagnosis)</term>
<term>Aortic Valve Stenosis (surgery)</term>
<term>Cardiac Catheterization (instrumentation)</term>
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<front>
<div type="abstract" xml:lang="en">The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical (DFM) system for the treatment of severe aortic stenosis.</div>
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<DateCreated>
<Year>2014</Year>
<Month>02</Month>
<Day>28</Day>
</DateCreated>
<DateCompleted>
<Year>2014</Year>
<Month>04</Month>
<Day>22</Day>
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<Year>2014</Year>
<Month>02</Month>
<Day>28</Day>
</DateRevised>
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<Journal>
<ISSN IssnType="Electronic">1558-3597</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>63</Volume>
<Issue>8</Issue>
<PubDate>
<Year>2014</Year>
<Month>Mar</Month>
<Day>04</Day>
</PubDate>
</JournalIssue>
<Title>Journal of the American College of Cardiology</Title>
<ISOAbbreviation>J. Am. Coll. Cardiol.</ISOAbbreviation>
</Journal>
<ArticleTitle>Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve.</ArticleTitle>
<Pagination>
<MedlinePgn>763-8</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.jacc.2013.10.013</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S0735-1097(13)05747-1</ELocationID>
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<AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical (DFM) system for the treatment of severe aortic stenosis.</AbstractText>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The DFM transcatheter aortic valve system is a nonmetallic design with a pressurized support structure that allows precise positioning, retrieval, and assessment of valve performance prior to permanent implantation.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">One hundred high surgical risk patients with severe aortic stenosis were evaluated for the primary endpoint. There were 75 patients in the group evaluable for the secondary endpoints and 25 in the pre-specified roll-in training phase. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events adjudicated by clinical event committee and classified according to Valve Academic Research Consortium (VARC) criteria.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">There was 99% freedom from all cause mortality at 30 days (primary endpoint). VARC criteria defined 30 day combined freedom from patient safety event rate was 91% and overall device success was 93%. The post-implantation echocardiography results demonstrated mild or no aortic regurgitation in 99% (73 of 74) with a mean gradient of 12.6 ± 7.1 mm Hg (n = 72) and effective orifice area of 1.50 ± 0.56 cm(2) and New York Heart Association functional class was I or II in 92% of cases.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99% of patients.</AbstractText>
<CopyrightInformation>Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.</CopyrightInformation>
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<LastName>Schofer</LastName>
<ForeName>Joachim</ForeName>
<Initials>J</Initials>
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</AffiliationInfo>
</Author>
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<LastName>Colombo</LastName>
<ForeName>Antonio</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>San Raffaele Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
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<LastName>Klugmann</LastName>
<ForeName>Silvio</ForeName>
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<LastName>Fajadet</LastName>
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</AffiliationInfo>
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<LastName>DeMarco</LastName>
<ForeName>Federico</ForeName>
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<LastName>Tchétché</LastName>
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<LastName>Bruschi</LastName>
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<LastName>Redwood</LastName>
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<LastName>Mullen</LastName>
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<LastName>Yap</LastName>
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<LastName>Grube</LastName>
<ForeName>Eberhard</ForeName>
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<LastName>Davidson</LastName>
<ForeName>Charles</ForeName>
<Initials>C</Initials>
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<Affiliation>L'Institut Cardiovasculaire Paris Sud, L'Institut Hospitalier Jacques Cartier, Massy, France.</Affiliation>
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<Month>11</Month>
<Day>06</Day>
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<Keyword MajorTopicYN="N">TAVR</Keyword>
<Keyword MajorTopicYN="N">aortic regurgitation</Keyword>
<Keyword MajorTopicYN="N">aortic valve stenosis</Keyword>
<Keyword MajorTopicYN="N">transfemoral</Keyword>
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<Year>2013</Year>
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<Month>10</Month>
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<Year>2014</Year>
<Month>4</Month>
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<li>Allemagne</li>
<li>France</li>
<li>Italie</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
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<li>Angleterre</li>
<li>Californie</li>
<li>District de Cologne</li>
<li>District de Columbia</li>
<li>Hambourg</li>
<li>Illinois</li>
<li>Lombardie</li>
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<li>Occitanie (région administrative)</li>
<li>Rhénanie-du-Nord-Westphalie</li>
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<li>Bonn</li>
<li>Hambourg</li>
<li>Milan</li>
<li>Toulouse</li>
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<name sortKey="Bijuklic, Klaudija" sort="Bijuklic, Klaudija" uniqKey="Bijuklic K" first="Klaudija" last="Bijuklic">Klaudija Bijuklic</name>
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<name sortKey="Mullen, Michael" sort="Mullen, Michael" uniqKey="Mullen M" first="Michael" last="Mullen">Michael Mullen</name>
<name sortKey="Nickenig, Georg" sort="Nickenig, Georg" uniqKey="Nickenig G" first="Georg" last="Nickenig">Georg Nickenig</name>
<name sortKey="Sinning, Jan Malte" sort="Sinning, Jan Malte" uniqKey="Sinning J" first="Jan-Malte" last="Sinning">Jan-Malte Sinning</name>
<name sortKey="Yap, John" sort="Yap, John" uniqKey="Yap J" first="John" last="Yap">John Yap</name>
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<name sortKey="Colombo, Antonio" sort="Colombo, Antonio" uniqKey="Colombo A" first="Antonio" last="Colombo">Antonio Colombo</name>
</region>
<name sortKey="Bruschi, Giuseppe" sort="Bruschi, Giuseppe" uniqKey="Bruschi G" first="Giuseppe" last="Bruschi">Giuseppe Bruschi</name>
<name sortKey="Demarco, Federico" sort="Demarco, Federico" uniqKey="Demarco F" first="Federico" last="Demarco">Federico Demarco</name>
<name sortKey="Klugmann, Silvio" sort="Klugmann, Silvio" uniqKey="Klugmann S" first="Silvio" last="Klugmann">Silvio Klugmann</name>
<name sortKey="Latib, Azeem" sort="Latib, Azeem" uniqKey="Latib A" first="Azeem" last="Latib">Azeem Latib</name>
<name sortKey="Maisano, Francesco" sort="Maisano, Francesco" uniqKey="Maisano F" first="Francesco" last="Maisano">Francesco Maisano</name>
</country>
<country name="France">
<region name="Occitanie (région administrative)">
<name sortKey="Fajadet, Jean" sort="Fajadet, Jean" uniqKey="Fajadet J" first="Jean" last="Fajadet">Jean Fajadet</name>
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<name sortKey="Davidson, Charles" sort="Davidson, Charles" uniqKey="Davidson C" first="Charles" last="Davidson">Charles Davidson</name>
<name sortKey="Tchetche, Didier" sort="Tchetche, Didier" uniqKey="Tchetche D" first="Didier" last="Tchétché">Didier Tchétché</name>
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<country name="États-Unis">
<region name="District de Columbia">
<name sortKey="Weissman, Neil" sort="Weissman, Neil" uniqKey="Weissman N" first="Neil" last="Weissman">Neil Weissman</name>
</region>
<name sortKey="Lefevre, Thierry" sort="Lefevre, Thierry" uniqKey="Lefevre T" first="Thierry" last="Lefevre">Thierry Lefevre</name>
<name sortKey="Schmoeckel, Michael" sort="Schmoeckel, Michael" uniqKey="Schmoeckel M" first="Michael" last="Schmoeckel">Michael Schmoeckel</name>
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<country name="Royaume-Uni">
<region name="Angleterre">
<name sortKey="Low, Reginald" sort="Low, Reginald" uniqKey="Low R" first="Reginald" last="Low">Reginald Low</name>
</region>
<name sortKey="Redwood, Simon" sort="Redwood, Simon" uniqKey="Redwood S" first="Simon" last="Redwood">Simon Redwood</name>
<name sortKey="Thomas, Martyn" sort="Thomas, Martyn" uniqKey="Thomas M" first="Martyn" last="Thomas">Martyn Thomas</name>
<name sortKey="Young, Christopher" sort="Young, Christopher" uniqKey="Young C" first="Christopher" last="Young">Christopher Young</name>
</country>
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</affiliations>
</record>

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