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

Identifieur interne : 000377 ( PubMed/Corpus ); précédent : 000376; suivant : 000378

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

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

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

Links to Exploration step

pubmed:24211506

Le document en format XML

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<nlm:affiliation>Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg University Cardiovascular Center, Hamburg, Germany. Electronic address: schofer@herz-hh.de.</nlm:affiliation>
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<name sortKey="Demarco, Federico" sort="Demarco, Federico" uniqKey="Demarco F" first="Federico" last="Demarco">Federico Demarco</name>
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<nlm:affiliation>Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg University Cardiovascular Center, Hamburg, Germany.</nlm:affiliation>
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<name sortKey="Weissman, Neil" sort="Weissman, Neil" uniqKey="Weissman N" first="Neil" last="Weissman">Neil Weissman</name>
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<nlm:affiliation>MedStar Health Research Institute, Georgetown University, Washington, DC.</nlm:affiliation>
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<name sortKey="Low, Reginald" sort="Low, Reginald" uniqKey="Low R" first="Reginald" last="Low">Reginald Low</name>
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<nlm:affiliation>University of California Davis, Davis, California; St. Thomas' Hospital, London, England.</nlm:affiliation>
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<name sortKey="Thomas, Martyn" sort="Thomas, Martyn" uniqKey="Thomas M" first="Martyn" last="Thomas">Martyn Thomas</name>
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<name sortKey="Young, Christopher" sort="Young, Christopher" uniqKey="Young C" first="Christopher" last="Young">Christopher Young</name>
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<name sortKey="Redwood, Simon" sort="Redwood, Simon" uniqKey="Redwood S" first="Simon" last="Redwood">Simon Redwood</name>
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<nlm:affiliation>The Heart Hospital, London, England.</nlm:affiliation>
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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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<nlm:affiliation>University Hospital Bonn, Bonn, Germany.</nlm:affiliation>
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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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<nlm:affiliation>University Hospital Bonn, Bonn, Germany.</nlm:affiliation>
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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="Nickenig, Georg" sort="Nickenig, Georg" uniqKey="Nickenig G" first="Georg" last="Nickenig">Georg Nickenig</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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<nlm:affiliation>Asklepios Klinik St Georg, Hamburg, Germany.</nlm:affiliation>
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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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<nlm:affiliation>Asklepios Klinik St Georg, Hamburg, Germany.</nlm:affiliation>
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<name sortKey="Lauterbach, Michael" sort="Lauterbach, Michael" uniqKey="Lauterbach M" first="Michael" last="Lauterbach">Michael Lauterbach</name>
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<nlm:affiliation>Asklepios Klinik St Georg, Hamburg, Germany.</nlm:affiliation>
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<name sortKey="Schmoeckel, Michael" sort="Schmoeckel, Michael" uniqKey="Schmoeckel M" first="Michael" last="Schmoeckel">Michael Schmoeckel</name>
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<nlm:affiliation>Northwestern Memorial Hospital, Chicago, Illinois.</nlm:affiliation>
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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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<nlm:affiliation>Clinique Pasteur, Toulouse, France.</nlm:affiliation>
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<name sortKey="Demarco, Federico" sort="Demarco, Federico" uniqKey="Demarco F" first="Federico" last="Demarco">Federico Demarco</name>
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<nlm:affiliation>Azienda Ospedaliera Niguarda Ca Granda, Milan, Italy.</nlm:affiliation>
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<name sortKey="Tchetche, Didier" sort="Tchetche, Didier" uniqKey="Tchetche D" first="Didier" last="Tchétché">Didier Tchétché</name>
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<name sortKey="Latib, Azeem" sort="Latib, Azeem" uniqKey="Latib A" first="Azeem" last="Latib">Azeem Latib</name>
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<nlm:affiliation>San Raffaele Hospital, Milan, Italy.</nlm:affiliation>
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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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<nlm:affiliation>Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg University Cardiovascular Center, Hamburg, Germany.</nlm:affiliation>
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<name sortKey="Weissman, Neil" sort="Weissman, Neil" uniqKey="Weissman N" first="Neil" last="Weissman">Neil Weissman</name>
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<nlm:affiliation>MedStar Health Research Institute, Georgetown University, Washington, DC.</nlm:affiliation>
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<name sortKey="Low, Reginald" sort="Low, Reginald" uniqKey="Low R" first="Reginald" last="Low">Reginald Low</name>
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<nlm:affiliation>University of California Davis, Davis, California; St. Thomas' Hospital, London, England.</nlm:affiliation>
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<name sortKey="Thomas, Martyn" sort="Thomas, Martyn" uniqKey="Thomas M" first="Martyn" last="Thomas">Martyn Thomas</name>
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<name sortKey="Young, Christopher" sort="Young, Christopher" uniqKey="Young C" first="Christopher" last="Young">Christopher Young</name>
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<nlm:affiliation>The Heart Hospital, London, England.</nlm:affiliation>
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<name sortKey="Redwood, Simon" sort="Redwood, Simon" uniqKey="Redwood S" first="Simon" last="Redwood">Simon Redwood</name>
<affiliation>
<nlm:affiliation>The Heart Hospital, London, England.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Mullen, Michael" sort="Mullen, Michael" uniqKey="Mullen M" first="Michael" last="Mullen">Michael Mullen</name>
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<nlm:affiliation>University Hospital Bonn, Bonn, Germany.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Yap, John" sort="Yap, John" uniqKey="Yap J" first="John" last="Yap">John Yap</name>
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<nlm:affiliation>University Hospital Bonn, Bonn, Germany.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Grube, Eberhard" sort="Grube, Eberhard" uniqKey="Grube E" first="Eberhard" last="Grube">Eberhard Grube</name>
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<nlm:affiliation>Krankenhaus der Barmherzigen, Trier, Germany.</nlm:affiliation>
</affiliation>
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<author>
<name sortKey="Nickenig, Georg" sort="Nickenig, Georg" uniqKey="Nickenig G" first="Georg" last="Nickenig">Georg Nickenig</name>
<affiliation>
<nlm:affiliation>Krankenhaus der Barmherzigen, Trier, Germany.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Sinning, Jan Malte" sort="Sinning, Jan Malte" uniqKey="Sinning J" first="Jan-Malte" last="Sinning">Jan-Malte Sinning</name>
<affiliation>
<nlm:affiliation>Krankenhaus der Barmherzigen, Trier, Germany.</nlm:affiliation>
</affiliation>
</author>
<author>
<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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<nlm:affiliation>Asklepios Klinik St Georg, Hamburg, Germany.</nlm:affiliation>
</affiliation>
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<author>
<name sortKey="Friedrich, Ivar" sort="Friedrich, Ivar" uniqKey="Friedrich I" first="Ivar" last="Friedrich">Ivar Friedrich</name>
<affiliation>
<nlm:affiliation>Asklepios Klinik St Georg, Hamburg, Germany.</nlm:affiliation>
</affiliation>
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<author>
<name sortKey="Lauterbach, Michael" sort="Lauterbach, Michael" uniqKey="Lauterbach M" first="Michael" last="Lauterbach">Michael Lauterbach</name>
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<nlm:affiliation>Asklepios Klinik St Georg, Hamburg, Germany.</nlm:affiliation>
</affiliation>
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<name sortKey="Schmoeckel, Michael" sort="Schmoeckel, Michael" uniqKey="Schmoeckel M" first="Michael" last="Schmoeckel">Michael Schmoeckel</name>
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<nlm:affiliation>Northwestern Memorial Hospital, Chicago, Illinois.</nlm:affiliation>
</affiliation>
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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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<nlm:affiliation>L'Institut Cardiovasculaire Paris Sud, L'Institut Hospitalier Jacques Cartier, Massy, France.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Lefevre, Thierry" sort="Lefevre, Thierry" uniqKey="Lefevre T" first="Thierry" last="Lefevre">Thierry Lefevre</name>
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<nlm:affiliation>Clinical Imaging Analytics, Guerneville, California.</nlm:affiliation>
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<title level="j">Journal of the American College of Cardiology</title>
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<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Animals</term>
<term>Aortic Valve (pathology)</term>
<term>Aortic Valve (surgery)</term>
<term>Aortic Valve Stenosis (diagnosis)</term>
<term>Aortic Valve Stenosis (surgery)</term>
<term>Cardiac Catheterization (instrumentation)</term>
<term>Cardiac Catheterization (methods)</term>
<term>Cattle</term>
<term>Cohort Studies</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Heart Valve Prosthesis</term>
<term>Heart Valve Prosthesis Implantation (instrumentation)</term>
<term>Heart Valve Prosthesis Implantation (methods)</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Prospective Studies</term>
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<term>Aortic Valve Stenosis</term>
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<term>Cardiac Catheterization</term>
<term>Heart Valve Prosthesis Implantation</term>
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<term>Heart Valve Prosthesis Implantation</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>
</front>
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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>
</DateCompleted>
<DateRevised>
<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>
<Abstract>
<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>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Schofer</LastName>
<ForeName>Joachim</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg University Cardiovascular Center, Hamburg, Germany. Electronic address: schofer@herz-hh.de.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Colombo</LastName>
<ForeName>Antonio</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>San Raffaele Hospital, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Klugmann</LastName>
<ForeName>Silvio</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Azienda Ospedaliera Niguarda Ca Granda, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Fajadet</LastName>
<ForeName>Jean</ForeName>
<Initials>J</Initials>
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<Affiliation>Clinique Pasteur, Toulouse, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>DeMarco</LastName>
<ForeName>Federico</ForeName>
<Initials>F</Initials>
<AffiliationInfo>
<Affiliation>Azienda Ospedaliera Niguarda Ca Granda, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Tchétché</LastName>
<ForeName>Didier</ForeName>
<Initials>D</Initials>
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