Serveur d'exploration sur les relations entre la France et l'Australie

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First Serial Assessment at 6 Months and 2 Years of the Second Generation of Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold: A Multi-Imaging Modality Study

Identifieur interne : 005012 ( PascalFrancis/Curation ); précédent : 005011; suivant : 005013

First Serial Assessment at 6 Months and 2 Years of the Second Generation of Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold: A Multi-Imaging Modality Study

Auteurs : John A. Ormiston [Nouvelle-Zélande] ; Patrick W. Serruys [Pays-Bas] ; Yoshinobu Onuma [Pays-Bas] ; Robert-Jan Van Geuns [Pays-Bas] ; Bernard De Bruyne [Belgique] ; Dariusz Dudek [Pologne] ; Leif Thuesen [Danemark] ; Pieter C. Smits [Pays-Bas] ; Bernard Chevalier [France] ; Dougal Mcclean [Nouvelle-Zélande] ; Jacques Koolen [Pays-Bas] ; Stephan Windecker [Suisse] ; Robert Whitbourn [Australie] ; Ian Meredith [Australie] ; Cecile Dorange [Belgique] ; Susan Veldhof [Belgique] ; Karine Miquel Hebert [Belgique] ; Richard Rapoza [États-Unis] ; Hector M. Garcia-Garcia [Pays-Bas]

Source :

RBID : Pascal:12-0423421

Descripteurs français

English descriptors

Abstract

Background-Nonserial observations have shown this bioresorbable scaffold to have no signs of area reduction at 6 months and recovery of vasomotion at 1 year. Serial observations at 6 months and 2 years have to confirm the absence of late restenosis or unfavorable imaging outcomes. Methods and Results-The ABSORB trial is a multicenter single-arm trial assessing the safety and performance of an everolimus-eluting bioresorbable vascular scaffold. Forty-five patients underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography at 6 and 24 months of follow-up. From 6 to 24 months, late luminal loss increased from 0.16±0.18 to 0.27±0.20 mm on quantitative coronary angiography, with an increase in neointima of 0.68±0.43 mm2 on optical coherence tomography and 0.17±0.26 mm2 on intravascular ultrasound. Struts still recognizable on optical coherence tomography at 2 years showed 99% of neointimal coverage with optical and ultrasonic signs of bioresorption accompanied by increase in mean scaffold area compared with baseline (0.54±1.09 mm2 on intravascular ultrasound, P=0.003 and 0.77±1.33 m2 on optical coherence tomography, P=0.016). Two-year major adverse cardiac event rate was 6.8% without any scaffold thrombosis. Conclusions-This serial analysis of the second generation of the everolimus-eluting bioresorbable vascular scaffold confirmed, at medium term, the safety and efficacy of the new device.
pA  
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A08 01  1  ENG  @1 First Serial Assessment at 6 Months and 2 Years of the Second Generation of Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold: A Multi-Imaging Modality Study
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A11 02  1    @1 SERRUYS (Patrick W.)
A11 03  1    @1 ONUMA (Yoshinobu)
A11 04  1    @1 GEUNS (Robert-Jan Van)
A11 05  1    @1 DE BRUYNE (Bernard)
A11 06  1    @1 DUDEK (Dariusz)
A11 07  1    @1 THUESEN (Leif)
A11 08  1    @1 SMITS (Pieter C.)
A11 09  1    @1 CHEVALIER (Bernard)
A11 10  1    @1 MCCLEAN (Dougal)
A11 11  1    @1 KOOLEN (Jacques)
A11 12  1    @1 WINDECKER (Stephan)
A11 13  1    @1 WHITBOURN (Robert)
A11 14  1    @1 MEREDITH (Ian)
A11 15  1    @1 DORANGE (Cecile)
A11 16  1    @1 VELDHOF (Susan)
A11 17  1    @1 MIQUEL HEBERT (Karine)
A11 18  1    @1 RAPOZA (Richard)
A11 19  1    @1 GARCIA-GARCIA (Hector M.)
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C01 01    ENG  @0 Background-Nonserial observations have shown this bioresorbable scaffold to have no signs of area reduction at 6 months and recovery of vasomotion at 1 year. Serial observations at 6 months and 2 years have to confirm the absence of late restenosis or unfavorable imaging outcomes. Methods and Results-The ABSORB trial is a multicenter single-arm trial assessing the safety and performance of an everolimus-eluting bioresorbable vascular scaffold. Forty-five patients underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography at 6 and 24 months of follow-up. From 6 to 24 months, late luminal loss increased from 0.16±0.18 to 0.27±0.20 mm on quantitative coronary angiography, with an increase in neointima of 0.68±0.43 mm2 on optical coherence tomography and 0.17±0.26 mm2 on intravascular ultrasound. Struts still recognizable on optical coherence tomography at 2 years showed 99% of neointimal coverage with optical and ultrasonic signs of bioresorption accompanied by increase in mean scaffold area compared with baseline (0.54±1.09 mm2 on intravascular ultrasound, P=0.003 and 0.77±1.33 m2 on optical coherence tomography, P=0.016). Two-year major adverse cardiac event rate was 6.8% without any scaffold thrombosis. Conclusions-This serial analysis of the second generation of the everolimus-eluting bioresorbable vascular scaffold confirmed, at medium term, the safety and efficacy of the new device.
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Pascal:12-0423421

Le document en format XML

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<name sortKey="Dorange, Cecile" sort="Dorange, Cecile" uniqKey="Dorange C" first="Cecile" last="Dorange">Cecile Dorange</name>
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<name sortKey="Miquel Hebert, Karine" sort="Miquel Hebert, Karine" uniqKey="Miquel Hebert K" first="Karine" last="Miquel Hebert">Karine Miquel Hebert</name>
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<name sortKey="Garcia Garcia, Hector M" sort="Garcia Garcia, Hector M" uniqKey="Garcia Garcia H" first="Hector M." last="Garcia-Garcia">Hector M. Garcia-Garcia</name>
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<title xml:lang="en" level="a">First Serial Assessment at 6 Months and 2 Years of the Second Generation of Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold: A Multi-Imaging Modality Study</title>
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<s1>Cardiovascular Center</s1>
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<s3>BEL</s3>
<sZ>5 aut.</sZ>
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<country>Belgique</country>
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<author>
<name sortKey="Dudek, Dariusz" sort="Dudek, Dariusz" uniqKey="Dudek D" first="Dariusz" last="Dudek">Dariusz Dudek</name>
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<s1>Jagiellonian University</s1>
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<country>Pologne</country>
</affiliation>
</author>
<author>
<name sortKey="Thuesen, Leif" sort="Thuesen, Leif" uniqKey="Thuesen L" first="Leif" last="Thuesen">Leif Thuesen</name>
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<inist:fA14 i1="05">
<s1>Skejby Sygehus University Hospital</s1>
<s2>Aarhus</s2>
<s3>DNK</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>Danemark</country>
</affiliation>
</author>
<author>
<name sortKey="Smits, Pieter C" sort="Smits, Pieter C" uniqKey="Smits P" first="Pieter C." last="Smits">Pieter C. Smits</name>
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<inist:fA14 i1="06">
<s1>Maasstad Hospital</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
</affiliation>
</author>
<author>
<name sortKey="Chevalier, Bernard" sort="Chevalier, Bernard" uniqKey="Chevalier B" first="Bernard" last="Chevalier">Bernard Chevalier</name>
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<inist:fA14 i1="07">
<s1>Institut Jacques Cartier</s1>
<s2>Massy</s2>
<s3>FRA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>France</country>
</affiliation>
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<author>
<name sortKey="Mcclean, Dougal" sort="Mcclean, Dougal" uniqKey="Mcclean D" first="Dougal" last="Mcclean">Dougal Mcclean</name>
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<inist:fA14 i1="08">
<s1>Christchurch Hospital</s1>
<s2>Christchurch</s2>
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<sZ>10 aut.</sZ>
</inist:fA14>
<country>Nouvelle-Zélande</country>
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<name sortKey="Koolen, Jacques" sort="Koolen, Jacques" uniqKey="Koolen J" first="Jacques" last="Koolen">Jacques Koolen</name>
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<inist:fA14 i1="09">
<s1>Catharina Hospital</s1>
<s2>Eindhoven</s2>
<s3>NLD</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
</affiliation>
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<name sortKey="Windecker, Stephan" sort="Windecker, Stephan" uniqKey="Windecker S" first="Stephan" last="Windecker">Stephan Windecker</name>
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<inist:fA14 i1="10">
<s1>Bern University Hospital</s1>
<s2>Bern</s2>
<s3>CHE</s3>
<sZ>12 aut.</sZ>
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<country>Suisse</country>
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</author>
<author>
<name sortKey="Whitbourn, Robert" sort="Whitbourn, Robert" uniqKey="Whitbourn R" first="Robert" last="Whitbourn">Robert Whitbourn</name>
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<inist:fA14 i1="11">
<s1>St Vincent's Hospital</s1>
<s2>Fitzroy</s2>
<s3>AUS</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Australie</country>
</affiliation>
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<name sortKey="Meredith, Ian" sort="Meredith, Ian" uniqKey="Meredith I" first="Ian" last="Meredith">Ian Meredith</name>
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<inist:fA14 i1="12">
<s1>Monash Cardiovascular Research Centre</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Australie</country>
</affiliation>
</author>
<author>
<name sortKey="Dorange, Cecile" sort="Dorange, Cecile" uniqKey="Dorange C" first="Cecile" last="Dorange">Cecile Dorange</name>
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<inist:fA14 i1="13">
<s1>Abbott Vascular</s1>
<s2>Diegem</s2>
<s3>BEL</s3>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>Belgique</country>
</affiliation>
</author>
<author>
<name sortKey="Veldhof, Susan" sort="Veldhof, Susan" uniqKey="Veldhof S" first="Susan" last="Veldhof">Susan Veldhof</name>
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<inist:fA14 i1="13">
<s1>Abbott Vascular</s1>
<s2>Diegem</s2>
<s3>BEL</s3>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>Belgique</country>
</affiliation>
</author>
<author>
<name sortKey="Miquel Hebert, Karine" sort="Miquel Hebert, Karine" uniqKey="Miquel Hebert K" first="Karine" last="Miquel Hebert">Karine Miquel Hebert</name>
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<inist:fA14 i1="13">
<s1>Abbott Vascular</s1>
<s2>Diegem</s2>
<s3>BEL</s3>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>Belgique</country>
</affiliation>
</author>
<author>
<name sortKey="Rapoza, Richard" sort="Rapoza, Richard" uniqKey="Rapoza R" first="Richard" last="Rapoza">Richard Rapoza</name>
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<inist:fA14 i1="14">
<s1>Abbott Vascular</s1>
<s2>Santa Clara, CA</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
</author>
<author>
<name sortKey="Garcia Garcia, Hector M" sort="Garcia Garcia, Hector M" uniqKey="Garcia Garcia H" first="Hector M." last="Garcia-Garcia">Hector M. Garcia-Garcia</name>
<affiliation wicri:level="1">
<inist:fA14 i1="15">
<s1>Cardialysis</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">Circulation. Cardiovascular interventions</title>
<title level="j" type="abbreviated">Circ. Cardiovasc. interv.</title>
<idno type="ISSN">1941-7640</idno>
<imprint>
<date when="2012">2012</date>
</imprint>
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<title level="j" type="main">Circulation. Cardiovascular interventions</title>
<title level="j" type="abbreviated">Circ. Cardiovasc. interv.</title>
<idno type="ISSN">1941-7640</idno>
</seriesStmt>
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<term>Artery</term>
<term>Complication</term>
<term>Coronary arteriography</term>
<term>Coronary heart disease</term>
<term>Hemodialysis</term>
<term>Human</term>
<term>Long term</term>
<term>Multicenter study</term>
<term>Nuclear magnetic resonance imaging</term>
<term>Optical coherence tomography</term>
<term>Preoperative</term>
<term>Prognosis</term>
<term>Restenosis</term>
<term>Stapling</term>
<term>Suturation</term>
<term>Test object</term>
<term>Three dimensional representation</term>
<term>Thrombosis</term>
<term>Ultrasound</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Thrombose</term>
<term>Cardiopathie coronaire</term>
<term>Resténose</term>
<term>Pronostic</term>
<term>Etude multicentrique</term>
<term>Homme</term>
<term>Coronarographie</term>
<term>Ultrason</term>
<term>Tomographie en cohérence optique</term>
<term>Complication</term>
<term>Représentation tridimensionnelle</term>
<term>Préopératoire</term>
<term>Suture chirurgicale</term>
<term>Hémodialyse</term>
<term>Imagerie RMN</term>
<term>Long terme</term>
<term>Fixation agrafe</term>
<term>Objet test</term>
<term>Artère</term>
<term>Compliance(volume pression)</term>
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<front>
<div type="abstract" xml:lang="en">Background-Nonserial observations have shown this bioresorbable scaffold to have no signs of area reduction at 6 months and recovery of vasomotion at 1 year. Serial observations at 6 months and 2 years have to confirm the absence of late restenosis or unfavorable imaging outcomes. Methods and Results-The ABSORB trial is a multicenter single-arm trial assessing the safety and performance of an everolimus-eluting bioresorbable vascular scaffold. Forty-five patients underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography at 6 and 24 months of follow-up. From 6 to 24 months, late luminal loss increased from 0.16±0.18 to 0.27±0.20 mm on quantitative coronary angiography, with an increase in neointima of 0.68±0.43 mm
<sup>2</sup>
on optical coherence tomography and 0.17±0.26 mm
<sup>2</sup>
on intravascular ultrasound. Struts still recognizable on optical coherence tomography at 2 years showed 99% of neointimal coverage with optical and ultrasonic signs of bioresorption accompanied by increase in mean scaffold area compared with baseline (0.54±1.09 mm
<sup>2</sup>
on intravascular ultrasound, P=0.003 and 0.77±1.33 m
<sup>2</sup>
on optical coherence tomography, P=0.016). Two-year major adverse cardiac event rate was 6.8% without any scaffold thrombosis. Conclusions-This serial analysis of the second generation of the everolimus-eluting bioresorbable vascular scaffold confirmed, at medium term, the safety and efficacy of the new device.</div>
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<s1>Maasstad Hospital</s1>
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<s1>Institut Jacques Cartier</s1>
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<sZ>9 aut.</sZ>
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<fA14 i1="08">
<s1>Christchurch Hospital</s1>
<s2>Christchurch</s2>
<s3>NZL</s3>
<sZ>10 aut.</sZ>
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<fA14 i1="09">
<s1>Catharina Hospital</s1>
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<sZ>11 aut.</sZ>
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<s1>Bern University Hospital</s1>
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<s2>Melbourne</s2>
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<s1>Abbott Vascular</s1>
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<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
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<s0>Background-Nonserial observations have shown this bioresorbable scaffold to have no signs of area reduction at 6 months and recovery of vasomotion at 1 year. Serial observations at 6 months and 2 years have to confirm the absence of late restenosis or unfavorable imaging outcomes. Methods and Results-The ABSORB trial is a multicenter single-arm trial assessing the safety and performance of an everolimus-eluting bioresorbable vascular scaffold. Forty-five patients underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography at 6 and 24 months of follow-up. From 6 to 24 months, late luminal loss increased from 0.16±0.18 to 0.27±0.20 mm on quantitative coronary angiography, with an increase in neointima of 0.68±0.43 mm
<sup>2</sup>
on optical coherence tomography and 0.17±0.26 mm
<sup>2</sup>
on intravascular ultrasound. Struts still recognizable on optical coherence tomography at 2 years showed 99% of neointimal coverage with optical and ultrasonic signs of bioresorption accompanied by increase in mean scaffold area compared with baseline (0.54±1.09 mm
<sup>2</sup>
on intravascular ultrasound, P=0.003 and 0.77±1.33 m
<sup>2</sup>
on optical coherence tomography, P=0.016). Two-year major adverse cardiac event rate was 6.8% without any scaffold thrombosis. Conclusions-This serial analysis of the second generation of the everolimus-eluting bioresorbable vascular scaffold confirmed, at medium term, the safety and efficacy of the new device.</s0>
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<fC03 i1="09" i2="X" l="ENG">
<s0>Optical coherence tomography</s0>
<s5>15</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Tomógrafo óptico de coherencia</s0>
<s5>15</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Complication</s0>
<s5>16</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Complication</s0>
<s5>16</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA">
<s0>Complicación</s0>
<s5>16</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE">
<s0>Représentation tridimensionnelle</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG">
<s0>Three dimensional representation</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA">
<s0>Representación tridimensional</s0>
<s5>17</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE">
<s0>Préopératoire</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG">
<s0>Preoperative</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA">
<s0>Preoperatorio</s0>
<s5>18</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE">
<s0>Suture chirurgicale</s0>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG">
<s0>Suturation</s0>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA">
<s0>Sutura quirúrgica</s0>
<s5>19</s5>
</fC03>
<fC03 i1="14" i2="X" l="FRE">
<s0>Hémodialyse</s0>
<s5>20</s5>
</fC03>
<fC03 i1="14" i2="X" l="ENG">
<s0>Hemodialysis</s0>
<s5>20</s5>
</fC03>
<fC03 i1="14" i2="X" l="SPA">
<s0>Hemodiálisis</s0>
<s5>20</s5>
</fC03>
<fC03 i1="15" i2="X" l="FRE">
<s0>Imagerie RMN</s0>
<s5>21</s5>
</fC03>
<fC03 i1="15" i2="X" l="ENG">
<s0>Nuclear magnetic resonance imaging</s0>
<s5>21</s5>
</fC03>
<fC03 i1="15" i2="X" l="SPA">
<s0>Imaginería RMN</s0>
<s5>21</s5>
</fC03>
<fC03 i1="16" i2="X" l="FRE">
<s0>Long terme</s0>
<s5>22</s5>
</fC03>
<fC03 i1="16" i2="X" l="ENG">
<s0>Long term</s0>
<s5>22</s5>
</fC03>
<fC03 i1="16" i2="X" l="SPA">
<s0>Largo plazo</s0>
<s5>22</s5>
</fC03>
<fC03 i1="17" i2="X" l="FRE">
<s0>Fixation agrafe</s0>
<s5>23</s5>
</fC03>
<fC03 i1="17" i2="X" l="ENG">
<s0>Stapling</s0>
<s5>23</s5>
</fC03>
<fC03 i1="17" i2="X" l="SPA">
<s0>Fijación con grapa</s0>
<s5>23</s5>
</fC03>
<fC03 i1="18" i2="X" l="FRE">
<s0>Objet test</s0>
<s5>24</s5>
</fC03>
<fC03 i1="18" i2="X" l="ENG">
<s0>Test object</s0>
<s5>24</s5>
</fC03>
<fC03 i1="18" i2="X" l="SPA">
<s0>Objeto prueba</s0>
<s5>24</s5>
</fC03>
<fC03 i1="19" i2="X" l="FRE">
<s0>Artère</s0>
<s5>25</s5>
</fC03>
<fC03 i1="19" i2="X" l="ENG">
<s0>Artery</s0>
<s5>25</s5>
</fC03>
<fC03 i1="19" i2="X" l="SPA">
<s0>Arteria</s0>
<s5>25</s5>
</fC03>
<fC03 i1="20" i2="X" l="FRE">
<s0>Compliance(volume pression)</s0>
<s4>INC</s4>
<s5>86</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Pathologie de l'appareil circulatoire</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Cardiovascular disease</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Aparato circulatorio patología</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Pathologie des vaisseaux sanguins</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Vascular disease</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Vaso sanguíneo patología</s0>
<s5>38</s5>
</fC07>
<fN21>
<s1>331</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>

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