Predictors of Paravalvular Regurgitation After Implantation of the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Valve (from the REPRISE II Trial Extended Cohort).
Identifieur interne : 000572 ( Main/Exploration ); précédent : 000571; suivant : 000573Predictors of Paravalvular Regurgitation After Implantation of the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Valve (from the REPRISE II Trial Extended Cohort).
Auteurs : Daniel J. Blackman [Royaume-Uni] ; Ian T. Meredith [États-Unis] ; Nicolas Dumonteil [France] ; Didier Tchétché [France] ; David Hildick-Smith [Royaume-Uni] ; Mark S. Spence [Royaume-Uni] ; Darren L. Walters [Australie] ; Jan Harnek [Suède] ; Stephen G. Worthley [Australie] ; Gilles Rioufol [France] ; Thierry Lefèvre [France] ; Vicki M. Houle [États-Unis] ; Dominic J. Allocco [États-Unis] ; Keith D. Dawkins [États-Unis]Source :
- The American journal of cardiology [ 1879-1913 ] ; 2017.
Descripteurs français
- KwdFr :
- Complications postopératoires, Conception de prothèse, Défaillance de prothèse, Femelle, Humains, Indice de gravité médicale, Insuffisance aortique (diagnostic), Insuffisance aortique (étiologie), Mâle, Pronostic, Prothèse valvulaire cardiaque (effets indésirables), Remplacement valvulaire aortique par cathéter (effets indésirables), Sténose aortique (), Sujet âgé de 80 ans ou plus, Tomodensitométrie multidétecteurs (), Valve aortique (), Échocardiographie, Études de suivi.
- MESH :
- diagnostic : Insuffisance aortique.
- effets indésirables : Prothèse valvulaire cardiaque, Remplacement valvulaire aortique par cathéter.
- étiologie : Insuffisance aortique.
- Complications postopératoires, Conception de prothèse, Défaillance de prothèse, Femelle, Humains, Indice de gravité médicale, Mâle, Pronostic, Sténose aortique, Sujet âgé de 80 ans ou plus, Tomodensitométrie multidétecteurs, Valve aortique, Échocardiographie, Études de suivi.
English descriptors
- KwdEn :
- Aged, 80 and over, Aortic Valve (surgery), Aortic Valve Insufficiency (diagnosis), Aortic Valve Insufficiency (etiology), Aortic Valve Stenosis (surgery), Echocardiography, Female, Follow-Up Studies, Heart Valve Prosthesis (adverse effects), Humans, Male, Multidetector Computed Tomography (methods), Postoperative Complications, Prognosis, Prosthesis Design, Prosthesis Failure, Severity of Illness Index, Transcatheter Aortic Valve Replacement (adverse effects).
- MESH :
- adverse effects : Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement.
- diagnosis : Aortic Valve Insufficiency.
- etiology : Aortic Valve Insufficiency.
- methods : Multidetector Computed Tomography.
- surgery : Aortic Valve, Aortic Valve Stenosis.
- Aged, 80 and over, Echocardiography, Female, Follow-Up Studies, Humans, Male, Postoperative Complications, Prognosis, Prosthesis Design, Prosthesis Failure, Severity of Illness Index.
Abstract
Paravalvular leak (PVL) after transcatheter aortic valve replacement is associated with worse long-term outcomes. The Lotus Valve incorporates an innovative Adaptive Seal designed to minimize PVL. This analysis evaluated the incidence and predictors of PVL after implantation of the Lotus transcatheter aortic valve. The REPRISE II (REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System - Evaluation of Safety and Performance) Study With Extended Cohort enrolled 250 high-surgical risk patients with severe symptomatic aortic stenosis. Aortic regurgitation was assessed by echocardiography pre-procedure, at discharge and 30 days, by an independent core laboratory. Baseline and procedural predictors of mild or greater PVL at 30 days (or at discharge if 30-day data were not available) were determined using a multivariate regression model (n = 229). Of the 229 patients, 197 (86%) had no/trace PVL, 30 had mild, and 2 had moderate PVL; no patient had severe PVL. Significant predictors of mild/moderate PVL included device:annulus area ratio (odds ratio [OR] 0.87; 95% CI 0.83 to 0.92; p <0.001), left ventricular outflow tract calcium volume (OR 2.85; 95% CI 1.44 to 5.63; p = 0.003), and annulus area (OR 0.89; 95% CI 0.82 to 0.96; p = 0.002). When the device:annulus area ratio was <1, the rate of mild/moderate PVL was 53.1% (17 of 32). The rates of mild/moderate PVL with 0% to 5%, 5% to 10%, and >10% annular oversizing by area were 17.5% (11 of 63), 2.9% (2 of 70), and 3.2% (2 of 63), respectively. Significant independent predictors of PVL included device:annulus area ratio and left ventricular outflow tract calcium volume. When the prosthetic valve was oversized by ≥5%, the rate of mild or greater PVL was only 3%. In conclusion, the overall rates of PVL with the Lotus Valve are low and predominantly related to device/annulus areas and calcium; these findings have implications for optimal device sizing.
DOI: 10.1016/j.amjcard.2017.04.026
PubMed: 28535962
Affiliations:
- Australie, France, Royaume-Uni, Suède, États-Unis
- Massachusetts, Midi-Pyrénées, Occitanie (région administrative)
- Toulouse
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Le document en format XML
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Blackman</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiology, Leeds Teaching Hospitals, Leeds, United Kingdom. Electronic address: daniel.blackman1@nhs.net.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Cardiology, Leeds Teaching Hospitals, Leeds</wicri:regionArea><wicri:noRegion>Leeds</wicri:noRegion></affiliation></author><author><name sortKey="Meredith, Ian T" sort="Meredith, Ian T" uniqKey="Meredith I" first="Ian T" last="Meredith">Ian T. Meredith</name><affiliation wicri:level="2"><nlm:affiliation>Division of Cardiology, MonashHeart, Monash Medical Centre and Monash University, Melbourne, Australia; Boston Scientific Corporation, Marlborough, Massachusetts.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Division of Cardiology, MonashHeart, Monash Medical Centre and Monash University, Melbourne, Australia; Boston Scientific Corporation, Marlborough</wicri:cityArea></affiliation></author><author><name sortKey="Dumonteil, Nicolas" sort="Dumonteil, Nicolas" uniqKey="Dumonteil N" first="Nicolas" last="Dumonteil">Nicolas Dumonteil</name><affiliation wicri:level="3"><nlm:affiliation>Department of Cardiology, Clinique Pasteur, Toulouse, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Cardiology, Clinique Pasteur, Toulouse</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Tchetche, Didier" sort="Tchetche, Didier" uniqKey="Tchetche D" first="Didier" last="Tchétché">Didier Tchétché</name><affiliation wicri:level="3"><nlm:affiliation>Department of Cardiology, Clinique Pasteur, Toulouse, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Cardiology, Clinique Pasteur, Toulouse</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Hildick Smith, David" sort="Hildick Smith, David" uniqKey="Hildick Smith D" first="David" last="Hildick-Smith">David Hildick-Smith</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiology, Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Cardiology, Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton</wicri:regionArea><wicri:noRegion>Brighton</wicri:noRegion></affiliation></author><author><name sortKey="Spence, Mark S" sort="Spence, Mark S" uniqKey="Spence M" first="Mark S" last="Spence">Mark S. Spence</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiology, Royal Victoria Hospital, Belfast, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Cardiology, Royal Victoria Hospital, Belfast</wicri:regionArea><wicri:noRegion>Belfast</wicri:noRegion></affiliation></author><author><name sortKey="Walters, Darren L" sort="Walters, Darren L" uniqKey="Walters D" first="Darren L" last="Walters">Darren L. Walters</name><affiliation wicri:level="1"><nlm:affiliation>Division of Cardiology, The Prince Charles Hospital, Brisbane, Queensland, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Division of Cardiology, The Prince Charles Hospital, Brisbane, Queensland</wicri:regionArea><wicri:noRegion>Queensland</wicri:noRegion></affiliation></author><author><name sortKey="Harnek, Jan" sort="Harnek, Jan" uniqKey="Harnek J" first="Jan" last="Harnek">Jan Harnek</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiology, University Hospital of Lund, Lund, Sweden.</nlm:affiliation><country xml:lang="fr">Suède</country><wicri:regionArea>Department of Cardiology, University Hospital of Lund, Lund</wicri:regionArea><wicri:noRegion>Lund</wicri:noRegion></affiliation></author><author><name sortKey="Worthley, Stephen G" sort="Worthley, Stephen G" uniqKey="Worthley S" first="Stephen G" last="Worthley">Stephen G. Worthley</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Cardiology, Royal Adelaide Hospital, Adelaide, South Australia</wicri:regionArea><wicri:noRegion>South Australia</wicri:noRegion></affiliation></author><author><name sortKey="Rioufol, Gilles" sort="Rioufol, Gilles" uniqKey="Rioufol G" first="Gilles" last="Rioufol">Gilles Rioufol</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiology, Hôpital Cardiologique de Lyon and INSERM 1060, CARMEN, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Cardiology, Hôpital Cardiologique de Lyon and INSERM 1060, CARMEN</wicri:regionArea><wicri:noRegion>CARMEN</wicri:noRegion><wicri:noRegion>CARMEN</wicri:noRegion></affiliation></author><author><name sortKey="Lefevre, Thierry" sort="Lefevre, Thierry" uniqKey="Lefevre T" first="Thierry" last="Lefèvre">Thierry Lefèvre</name><affiliation wicri:level="1"><nlm:affiliation>Department of Cardiology, Institut Cardiovasculaire-Paris Sud, Massy, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Cardiology, Institut Cardiovasculaire-Paris Sud, Massy</wicri:regionArea><wicri:noRegion>Massy</wicri:noRegion><wicri:noRegion>Massy</wicri:noRegion></affiliation></author><author><name sortKey="Houle, Vicki M" sort="Houle, Vicki M" uniqKey="Houle V" first="Vicki M" last="Houle">Vicki M. Houle</name><affiliation wicri:level="2"><nlm:affiliation>Boston Scientific Corporation, Marlborough, Massachusetts.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Boston Scientific Corporation, Marlborough</wicri:cityArea></affiliation></author><author><name sortKey="Allocco, Dominic J" sort="Allocco, Dominic J" uniqKey="Allocco D" first="Dominic J" last="Allocco">Dominic J. Allocco</name><affiliation wicri:level="2"><nlm:affiliation>Boston Scientific Corporation, Marlborough, Massachusetts.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Boston Scientific Corporation, Marlborough</wicri:cityArea></affiliation></author><author><name sortKey="Dawkins, Keith D" sort="Dawkins, Keith D" uniqKey="Dawkins K" first="Keith D" last="Dawkins">Keith D. Dawkins</name><affiliation wicri:level="2"><nlm:affiliation>Boston Scientific Corporation, Marlborough, Massachusetts.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Boston Scientific Corporation, Marlborough</wicri:cityArea></affiliation></author></analytic><series><title level="j">The American journal of cardiology</title><idno type="eISSN">1879-1913</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged, 80 and over</term><term>Aortic Valve (surgery)</term><term>Aortic Valve Insufficiency (diagnosis)</term><term>Aortic Valve Insufficiency (etiology)</term><term>Aortic Valve Stenosis (surgery)</term><term>Echocardiography</term><term>Female</term><term>Follow-Up Studies</term><term>Heart Valve Prosthesis (adverse effects)</term><term>Humans</term><term>Male</term><term>Multidetector Computed Tomography (methods)</term><term>Postoperative Complications</term><term>Prognosis</term><term>Prosthesis Design</term><term>Prosthesis Failure</term><term>Severity of Illness Index</term><term>Transcatheter Aortic Valve Replacement (adverse effects)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Complications postopératoires</term><term>Conception de prothèse</term><term>Défaillance de prothèse</term><term>Femelle</term><term>Humains</term><term>Indice de gravité médicale</term><term>Insuffisance aortique (diagnostic)</term><term>Insuffisance aortique (étiologie)</term><term>Mâle</term><term>Pronostic</term><term>Prothèse valvulaire cardiaque (effets indésirables)</term><term>Remplacement valvulaire aortique par cathéter (effets indésirables)</term><term>Sténose aortique ()</term><term>Sujet âgé de 80 ans ou plus</term><term>Tomodensitométrie multidétecteurs ()</term><term>Valve aortique ()</term><term>Échocardiographie</term><term>Études de suivi</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Heart Valve Prosthesis</term><term>Transcatheter Aortic Valve Replacement</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Aortic Valve Insufficiency</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Insuffisance aortique</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Prothèse valvulaire cardiaque</term><term>Remplacement valvulaire aortique par cathéter</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Aortic Valve Insufficiency</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Multidetector Computed Tomography</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Aortic Valve</term><term>Aortic Valve Stenosis</term></keywords><keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Insuffisance aortique</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged, 80 and over</term><term>Echocardiography</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Male</term><term>Postoperative Complications</term><term>Prognosis</term><term>Prosthesis Design</term><term>Prosthesis Failure</term><term>Severity of Illness Index</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Complications postopératoires</term><term>Conception de prothèse</term><term>Défaillance de prothèse</term><term>Femelle</term><term>Humains</term><term>Indice de gravité médicale</term><term>Mâle</term><term>Pronostic</term><term>Sténose aortique</term><term>Sujet âgé de 80 ans ou plus</term><term>Tomodensitométrie multidétecteurs</term><term>Valve aortique</term><term>Échocardiographie</term><term>Études de suivi</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Paravalvular leak (PVL) after transcatheter aortic valve replacement is associated with worse long-term outcomes. The Lotus Valve incorporates an innovative Adaptive Seal designed to minimize PVL. This analysis evaluated the incidence and predictors of PVL after implantation of the Lotus transcatheter aortic valve. The REPRISE II (REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System - Evaluation of Safety and Performance) Study With Extended Cohort enrolled 250 high-surgical risk patients with severe symptomatic aortic stenosis. Aortic regurgitation was assessed by echocardiography pre-procedure, at discharge and 30 days, by an independent core laboratory. Baseline and procedural predictors of mild or greater PVL at 30 days (or at discharge if 30-day data were not available) were determined using a multivariate regression model (n = 229). Of the 229 patients, 197 (86%) had no/trace PVL, 30 had mild, and 2 had moderate PVL; no patient had severe PVL. Significant predictors of mild/moderate PVL included device:annulus area ratio (odds ratio [OR] 0.87; 95% CI 0.83 to 0.92; p <0.001), left ventricular outflow tract calcium volume (OR 2.85; 95% CI 1.44 to 5.63; p = 0.003), and annulus area (OR 0.89; 95% CI 0.82 to 0.96; p = 0.002). When the device:annulus area ratio was <1, the rate of mild/moderate PVL was 53.1% (17 of 32). The rates of mild/moderate PVL with 0% to 5%, 5% to 10%, and >10% annular oversizing by area were 17.5% (11 of 63), 2.9% (2 of 70), and 3.2% (2 of 63), respectively. Significant independent predictors of PVL included device:annulus area ratio and left ventricular outflow tract calcium volume. When the prosthetic valve was oversized by ≥5%, the rate of mild or greater PVL was only 3%. In conclusion, the overall rates of PVL with the Lotus Valve are low and predominantly related to device/annulus areas and calcium; these findings have implications for optimal device sizing.</div></front></TEI><affiliations><list><country><li>Australie</li><li>France</li><li>Royaume-Uni</li><li>Suède</li><li>États-Unis</li></country><region><li>Massachusetts</li><li>Midi-Pyrénées</li><li>Occitanie (région administrative)</li></region><settlement><li>Toulouse</li></settlement></list><tree><country name="Royaume-Uni"><noRegion><name sortKey="Blackman, Daniel J" sort="Blackman, Daniel J" uniqKey="Blackman D" first="Daniel J" last="Blackman">Daniel J. Blackman</name></noRegion><name sortKey="Hildick Smith, David" sort="Hildick Smith, David" uniqKey="Hildick Smith D" first="David" last="Hildick-Smith">David Hildick-Smith</name><name sortKey="Spence, Mark S" sort="Spence, Mark S" uniqKey="Spence M" first="Mark S" last="Spence">Mark S. Spence</name></country><country name="États-Unis"><region name="Massachusetts"><name sortKey="Meredith, Ian T" sort="Meredith, Ian T" uniqKey="Meredith I" first="Ian T" last="Meredith">Ian T. Meredith</name></region><name sortKey="Allocco, Dominic J" sort="Allocco, Dominic J" uniqKey="Allocco D" first="Dominic J" last="Allocco">Dominic J. Allocco</name><name sortKey="Dawkins, Keith D" sort="Dawkins, Keith D" uniqKey="Dawkins K" first="Keith D" last="Dawkins">Keith D. Dawkins</name><name sortKey="Houle, Vicki M" sort="Houle, Vicki M" uniqKey="Houle V" first="Vicki M" last="Houle">Vicki M. Houle</name></country><country name="France"><region name="Occitanie (région administrative)"><name sortKey="Dumonteil, Nicolas" sort="Dumonteil, Nicolas" uniqKey="Dumonteil N" first="Nicolas" last="Dumonteil">Nicolas Dumonteil</name></region><name sortKey="Lefevre, Thierry" sort="Lefevre, Thierry" uniqKey="Lefevre T" first="Thierry" last="Lefèvre">Thierry Lefèvre</name><name sortKey="Rioufol, Gilles" sort="Rioufol, Gilles" uniqKey="Rioufol G" first="Gilles" last="Rioufol">Gilles Rioufol</name><name sortKey="Tchetche, Didier" sort="Tchetche, Didier" uniqKey="Tchetche D" first="Didier" last="Tchétché">Didier Tchétché</name></country><country name="Australie"><noRegion><name sortKey="Walters, Darren L" sort="Walters, Darren L" uniqKey="Walters D" first="Darren L" last="Walters">Darren L. Walters</name></noRegion><name sortKey="Worthley, Stephen G" sort="Worthley, Stephen G" uniqKey="Worthley S" first="Stephen G" last="Worthley">Stephen G. Worthley</name></country><country name="Suède"><noRegion><name sortKey="Harnek, Jan" sort="Harnek, Jan" uniqKey="Harnek J" first="Jan" last="Harnek">Jan Harnek</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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