PittsburghV1, Main, Exploration, bibRecord, 004D71

Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis

Identifieur interne : 004D71 ( Main/Exploration ); précédent : 004D70; suivant : 004D72

Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis

Auteurs : David H. Adams [États-Unis] ; Jeffrey J. Popma [États-Unis] ; Michael J. Reardon [États-Unis] ; Steven J. Yakubov [États-Unis] ; Joseph S. Coselli [États-Unis] ; G. Michael Deeb [États-Unis] ; Thomas G. Gleason [États-Unis] ; Maurice Buchbinder [États-Unis] ; James Jr Hermiller [États-Unis] ; Neal S. Kleiman [États-Unis] ; Stan Chetcuti [États-Unis] ; John Heiser [États-Unis] ; William Merhi [États-Unis] ; George Zorn [États-Unis] ; Peter Tadros [États-Unis] ; Newell Robinson [États-Unis] ; George Petrossian [États-Unis] ; G. Chad Hughes [États-Unis] ; J. Kevin Harrison [États-Unis] ; John Conte [États-Unis] ; Brijeshwar Maini [États-Unis] ; Mubashir Mumtaz [États-Unis] ; Sharla Chenoweth [États-Unis] ; Jae K. Oh [États-Unis]

Source :

The New England journal of medicine [ 0028-4793 ] ; 2014.

RBID : Pascal:14-0139364

Descripteurs français

Pascal (Inist)
- Prothèse, Valvule aortique, Médecine.
Wicri :
- topic : Médecine.

English descriptors

KwdEn :
- Aortic valve, Medicine, Prosthesis.

Abstract

BACKGROUND We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery. METHODS We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing. RESULTS A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, -0.4; P<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke. CONCLUSIONS In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement.

Affiliations:

États-Unis
Maryland, Massachusetts, Michigan, Minnesota, Pennsylvanie, Texas, État de New York
Baltimore, Boston, Houston, Pittsburgh

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Le document en format XML

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<author><name sortKey="Chetcuti, Stan" sort="Chetcuti, Stan" uniqKey="Chetcuti S" first="Stan" last="Chetcuti">Stan Chetcuti</name>
<affiliation wicri:level="2"><inist:fA14 i1="07"><s1>University of Michigan Medical Center</s1>
<s2>Ann Arbor, Michigan</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Michigan</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Heiser, John" sort="Heiser, John" uniqKey="Heiser J" first="John" last="Heiser">John Heiser</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>St. Vincent Medical Center</s1>
<s2>Indianapolis</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>St. Vincent Medical Center</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Merhi, William" sort="Merhi, William" uniqKey="Merhi W" first="William" last="Merhi">William Merhi</name>
<affiliation wicri:level="2"><inist:fA14 i1="08"><s1>Spectrum Health Hospitals</s1>
<s2>Grand Rapids, Michigan</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Michigan</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Zorn, George" sort="Zorn, George" uniqKey="Zorn G" first="George" last="Zorn">George Zorn</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>University of Kansas Hospital</s1>
<s2>Kansas City</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>University of Kansas Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Tadros, Peter" sort="Tadros, Peter" uniqKey="Tadros P" first="Peter" last="Tadros">Peter Tadros</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>University of Kansas Hospital</s1>
<s2>Kansas City</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>University of Kansas Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Robinson, Newell" sort="Robinson, Newell" uniqKey="Robinson N" first="Newell" last="Robinson">Newell Robinson</name>
<affiliation wicri:level="2"><inist:fA14 i1="02"><s1>St. Francis Hospital</s1>
<s2>Roslyn, New York</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Petrossian, George" sort="Petrossian, George" uniqKey="Petrossian G" first="George" last="Petrossian">George Petrossian</name>
<affiliation wicri:level="2"><inist:fA14 i1="02"><s1>St. Francis Hospital</s1>
<s2>Roslyn, New York</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Hughes, G Chad" sort="Hughes, G Chad" uniqKey="Hughes G" first="G. Chad" last="Hughes">G. Chad Hughes</name>
<affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Duke University Medical Center</s1>
<s2>Durham, NC</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Duke University Medical Center</wicri:noRegion>
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</author>
<author><name sortKey="Harrison, J Kevin" sort="Harrison, J Kevin" uniqKey="Harrison J" first="J. Kevin" last="Harrison">J. Kevin Harrison</name>
<affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Duke University Medical Center</s1>
<s2>Durham, NC</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Duke University Medical Center</wicri:noRegion>
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</author>
<author><name sortKey="Conte, John" sort="Conte, John" uniqKey="Conte J" first="John" last="Conte">John Conte</name>
<affiliation wicri:level="3"><inist:fA14 i1="14"><s1>Johns Hopkins Hospital</s1>
<s2>Baltimore</s2>
<s3>USA</s3>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><settlement type="city">Baltimore</settlement>
<region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Maini, Brijeshwar" sort="Maini, Brijeshwar" uniqKey="Maini B" first="Brijeshwar" last="Maini">Brijeshwar Maini</name>
<affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Pinnacle Health</s1>
<s2>Harrisburg, PA</s2>
<s3>USA</s3>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Pinnacle Health</wicri:noRegion>
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<author><name sortKey="Mumtaz, Mubashir" sort="Mumtaz, Mubashir" uniqKey="Mumtaz M" first="Mubashir" last="Mumtaz">Mubashir Mumtaz</name>
<affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Pinnacle Health</s1>
<s2>Harrisburg, PA</s2>
<s3>USA</s3>
<sZ>21 aut.</sZ>
<sZ>22 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Pinnacle Health</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Chenoweth, Sharla" sort="Chenoweth, Sharla" uniqKey="Chenoweth S" first="Sharla" last="Chenoweth">Sharla Chenoweth</name>
<affiliation wicri:level="2"><inist:fA14 i1="16"><s1>Medtronic</s1>
<s2>Minneapolis, Minnesota</s2>
<s3>USA</s3>
<sZ>23 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Minnesota</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Oh, Jae K" sort="Oh, Jae K" uniqKey="Oh J" first="Jae K." last="Oh">Jae K. Oh</name>
<affiliation wicri:level="2"><inist:fA14 i1="17"><s1>Mayo Clinical Foundation</s1>
<s2>Rochester, Minnesota</s2>
<s3>USA</s3>
<sZ>24 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Minnesota</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
<imprint><date when="2014">2014</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aortic valve</term>
<term>Medicine</term>
<term>Prosthesis</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Prothèse</term>
<term>Valvule aortique</term>
<term>Médecine</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Médecine</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">BACKGROUND We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery. METHODS We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing. RESULTS A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, -0.4; P<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke. CONCLUSIONS In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement.</div>
</front>
</TEI>
<affiliations><list><country><li>États-Unis</li>
</country>
<region><li>Maryland</li>
<li>Massachusetts</li>
<li>Michigan</li>
<li>Minnesota</li>
<li>Pennsylvanie</li>
<li>Texas</li>
<li>État de New York</li>
</region>
<settlement><li>Baltimore</li>
<li>Boston</li>
<li>Houston</li>
<li>Pittsburgh</li>
</settlement>
</list>
<tree><country name="États-Unis"><region name="État de New York"><name sortKey="Adams, David H" sort="Adams, David H" uniqKey="Adams D" first="David H." last="Adams">David H. Adams</name>
</region>
<name sortKey="Buchbinder, Maurice" sort="Buchbinder, Maurice" uniqKey="Buchbinder M" first="Maurice" last="Buchbinder">Maurice Buchbinder</name>
<name sortKey="Chenoweth, Sharla" sort="Chenoweth, Sharla" uniqKey="Chenoweth S" first="Sharla" last="Chenoweth">Sharla Chenoweth</name>
<name sortKey="Chetcuti, Stan" sort="Chetcuti, Stan" uniqKey="Chetcuti S" first="Stan" last="Chetcuti">Stan Chetcuti</name>
<name sortKey="Conte, John" sort="Conte, John" uniqKey="Conte J" first="John" last="Conte">John Conte</name>
<name sortKey="Coselli, Joseph S" sort="Coselli, Joseph S" uniqKey="Coselli J" first="Joseph S." last="Coselli">Joseph S. Coselli</name>
<name sortKey="Deeb, G Michael" sort="Deeb, G Michael" uniqKey="Deeb G" first="G. Michael" last="Deeb">G. Michael Deeb</name>
<name sortKey="Gleason, Thomas G" sort="Gleason, Thomas G" uniqKey="Gleason T" first="Thomas G." last="Gleason">Thomas G. Gleason</name>
<name sortKey="Harrison, J Kevin" sort="Harrison, J Kevin" uniqKey="Harrison J" first="J. Kevin" last="Harrison">J. Kevin Harrison</name>
<name sortKey="Heiser, John" sort="Heiser, John" uniqKey="Heiser J" first="John" last="Heiser">John Heiser</name>
<name sortKey="Hermiller, James Jr" sort="Hermiller, James Jr" uniqKey="Hermiller J" first="James Jr" last="Hermiller">James Jr Hermiller</name>
<name sortKey="Hughes, G Chad" sort="Hughes, G Chad" uniqKey="Hughes G" first="G. Chad" last="Hughes">G. Chad Hughes</name>
<name sortKey="Kleiman, Neal S" sort="Kleiman, Neal S" uniqKey="Kleiman N" first="Neal S." last="Kleiman">Neal S. Kleiman</name>
<name sortKey="Maini, Brijeshwar" sort="Maini, Brijeshwar" uniqKey="Maini B" first="Brijeshwar" last="Maini">Brijeshwar Maini</name>
<name sortKey="Merhi, William" sort="Merhi, William" uniqKey="Merhi W" first="William" last="Merhi">William Merhi</name>
<name sortKey="Mumtaz, Mubashir" sort="Mumtaz, Mubashir" uniqKey="Mumtaz M" first="Mubashir" last="Mumtaz">Mubashir Mumtaz</name>
<name sortKey="Oh, Jae K" sort="Oh, Jae K" uniqKey="Oh J" first="Jae K." last="Oh">Jae K. Oh</name>
<name sortKey="Petrossian, George" sort="Petrossian, George" uniqKey="Petrossian G" first="George" last="Petrossian">George Petrossian</name>
<name sortKey="Popma, Jeffrey J" sort="Popma, Jeffrey J" uniqKey="Popma J" first="Jeffrey J." last="Popma">Jeffrey J. Popma</name>
<name sortKey="Reardon, Michael J" sort="Reardon, Michael J" uniqKey="Reardon M" first="Michael J." last="Reardon">Michael J. Reardon</name>
<name sortKey="Robinson, Newell" sort="Robinson, Newell" uniqKey="Robinson N" first="Newell" last="Robinson">Newell Robinson</name>
<name sortKey="Tadros, Peter" sort="Tadros, Peter" uniqKey="Tadros P" first="Peter" last="Tadros">Peter Tadros</name>
<name sortKey="Yakubov, Steven J" sort="Yakubov, Steven J" uniqKey="Yakubov S" first="Steven J." last="Yakubov">Steven J. Yakubov</name>
<name sortKey="Zorn, George" sort="Zorn, George" uniqKey="Zorn G" first="George" last="Zorn">George Zorn</name>
</country>
</tree>
</affiliations>
</record>

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Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis

Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis

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