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Myocardial Injury After Balloon Predilatation Versus Direct Transcatheter Aortic Valve Replacement: Insights From the DIRECTAVI Trial

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Τίτλος: Myocardial Injury After Balloon Predilatation Versus Direct Transcatheter Aortic Valve Replacement: Insights From the DIRECTAVI Trial
Συγγραφείς: Akodad, Mariama, Roubille, François, Marin, Gregory, Lattuca, Benoit, Macia, Jean‐christophe, Delseny, Delphine, Gandet, Thomas, Robert, Pierre, Schmutz, Laurent, Piot, Christophe, Maupas, Eric, Robert, Gabriel, Targosz, Frederic, Albat, Bernard, Cayla, Guillaume, Leclercq, Florence
Συνεισφορές: Physiologie & médecine expérimentale du Cœur et des Muscles U 1046 (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Biomécanique des Interactions et de l'Organisation des Tissus et des Cellules (BIOTIC), Laboratoire de Mécanique et Génie Civil (LMGC), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), ThermoMécanique des Matériaux (ThM2), Clinique du Millénaire - Oc Santé Montpellier, Oc Santé Montpellier, Hôpital privé les Franciscaines, Centre Hospitalier Saint Jean de Perpignan (CH Perpignan)
Πηγή: ISSN: 2047-9980 ; Journal of the American Heart Association ; https://hal.science/hal-03052611 ; Journal of the American Heart Association, 2020, 9 (24), pp.e018405. ⟨10.1161/JAHA.120.018405⟩.
Στοιχεία εκδότη: CCSD
Wiley-Blackwell
Έτος έκδοσης: 2020
Συλλογή: Université de Montpellier: HAL
Θεματικοί όροι: [SDV]Life Sciences [q-bio]
Περιγραφή: International audience ; BackgroundMyocardial injury is associated with higher mortality after transcatheter aortic valve replacement (TAVR) and might be increased by prior balloon aortic valvuloplasty (BAV). We aimed to evaluate the impact of prior BAV versus direct prosthesis implantation on myocardial injury occurring after (TAVR) with balloon‐expandable prostheses.Methods and ResultsThe DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) trial, an open‐label randomized study, demonstrated noninferiority of TAVR without BAV (direct TAVR group) compared with systematic BAV (BAV group) with the Edwards SAPIEN 3 valve. High‐sensitivity troponin was assessed before and the day after the procedure. Incidence of myocardial injury after the procedure (high‐sensitivity troponin elevation >15× the upper reference limit [14 ng/L]) was the main end point. Impact of myocardial injury on 1‐month adverse events (all‐cause mortality, stroke, major bleeding, major vascular complications, transfusion, acute kidney injury, heart failure, pacemaker implantation, and aortic regurgitation) was evaluated. Preprocedure and postprocedure high‐sensitivity troponin levels were available in 211 patients. The mean age of patients was 83 years (78–87 years), with 129 men (61.1%). Mean postprocedure high‐sensitivity troponin was 124.9±81.4 ng/L in the direct TAVR group versus 170.4±127.7 ng/L in the BAV group (P=0.007). Myocardial injury occurred in 42 patients (19.9%), including 13 patients (12.2%) in the direct TAVR group and 29 (27.9%) in the BAV group (P=0.004). BAV increased by 2.8‐fold (95% CI, 1.4–5.8) myocardial injury probability. Myocardial injury was associated with 1‐month adverse events (P=0.03).ConclusionsBAV increased the incidence and magnitude of myocardial injury after TAVR with new‐generation balloon‐expandable valves. Myocardial injury was associated with 1‐month adverse events. These results argue in favor of direct SAPIEN 3 valve implantation.
Τύπος εγγράφου: article in journal/newspaper
Γλώσσα: English
Relation: info:eu-repo/semantics/altIdentifier/pmid/33297821; PUBMED: 33297821; PUBMEDCENTRAL: PMC7955361
DOI: 10.1161/JAHA.120.018405
Διαθεσιμότητα: https://hal.science/hal-03052611
https://hal.science/hal-03052611v1/document
https://hal.science/hal-03052611v1/file/JAHA.120.018405.pdf
https://doi.org/10.1161/JAHA.120.018405
Rights: https://creativecommons.org/licenses/by-nc-nd/4.0/ ; info:eu-repo/semantics/OpenAccess
Αριθμός Καταχώρησης: edsbas.F569162C
Βάση Δεδομένων: BASE
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  Data: Myocardial Injury After Balloon Predilatation Versus Direct Transcatheter Aortic Valve Replacement: Insights From the DIRECTAVI Trial
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  Data: <searchLink fieldCode="AR" term="%22Akodad%2C+Mariama%22">Akodad, Mariama</searchLink><br /><searchLink fieldCode="AR" term="%22Roubille%2C+François%22">Roubille, François</searchLink><br /><searchLink fieldCode="AR" term="%22Marin%2C+Gregory%22">Marin, Gregory</searchLink><br /><searchLink fieldCode="AR" term="%22Lattuca%2C+Benoit%22">Lattuca, Benoit</searchLink><br /><searchLink fieldCode="AR" term="%22Macia%2C+Jean‐christophe%22">Macia, Jean‐christophe</searchLink><br /><searchLink fieldCode="AR" term="%22Delseny%2C+Delphine%22">Delseny, Delphine</searchLink><br /><searchLink fieldCode="AR" term="%22Gandet%2C+Thomas%22">Gandet, Thomas</searchLink><br /><searchLink fieldCode="AR" term="%22Robert%2C+Pierre%22">Robert, Pierre</searchLink><br /><searchLink fieldCode="AR" term="%22Schmutz%2C+Laurent%22">Schmutz, Laurent</searchLink><br /><searchLink fieldCode="AR" term="%22Piot%2C+Christophe%22">Piot, Christophe</searchLink><br /><searchLink fieldCode="AR" term="%22Maupas%2C+Eric%22">Maupas, Eric</searchLink><br /><searchLink fieldCode="AR" term="%22Robert%2C+Gabriel%22">Robert, Gabriel</searchLink><br /><searchLink fieldCode="AR" term="%22Targosz%2C+Frederic%22">Targosz, Frederic</searchLink><br /><searchLink fieldCode="AR" term="%22Albat%2C+Bernard%22">Albat, Bernard</searchLink><br /><searchLink fieldCode="AR" term="%22Cayla%2C+Guillaume%22">Cayla, Guillaume</searchLink><br /><searchLink fieldCode="AR" term="%22Leclercq%2C+Florence%22">Leclercq, Florence</searchLink>
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  Data: Physiologie & médecine expérimentale du Cœur et des Muscles U 1046 (PhyMedExp)<br />Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)<br />Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier)<br />Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)<br />Biomécanique des Interactions et de l'Organisation des Tissus et des Cellules (BIOTIC)<br />Laboratoire de Mécanique et Génie Civil (LMGC)<br />Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)<br />ThermoMécanique des Matériaux (ThM2)<br />Clinique du Millénaire - Oc Santé Montpellier<br />Oc Santé Montpellier<br />Hôpital privé les Franciscaines<br />Centre Hospitalier Saint Jean de Perpignan (CH Perpignan)
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  Data: <i>ISSN: 2047-9980 ; Journal of the American Heart Association ; https://hal.science/hal-03052611 ; Journal of the American Heart Association, 2020, 9 (24), pp.e018405. ⟨10.1161/JAHA.120.018405⟩</i>.
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  Data: International audience ; BackgroundMyocardial injury is associated with higher mortality after transcatheter aortic valve replacement (TAVR) and might be increased by prior balloon aortic valvuloplasty (BAV). We aimed to evaluate the impact of prior BAV versus direct prosthesis implantation on myocardial injury occurring after (TAVR) with balloon‐expandable prostheses.Methods and ResultsThe DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) trial, an open‐label randomized study, demonstrated noninferiority of TAVR without BAV (direct TAVR group) compared with systematic BAV (BAV group) with the Edwards SAPIEN 3 valve. High‐sensitivity troponin was assessed before and the day after the procedure. Incidence of myocardial injury after the procedure (high‐sensitivity troponin elevation >15× the upper reference limit [14 ng/L]) was the main end point. Impact of myocardial injury on 1‐month adverse events (all‐cause mortality, stroke, major bleeding, major vascular complications, transfusion, acute kidney injury, heart failure, pacemaker implantation, and aortic regurgitation) was evaluated. Preprocedure and postprocedure high‐sensitivity troponin levels were available in 211 patients. The mean age of patients was 83 years (78–87 years), with 129 men (61.1%). Mean postprocedure high‐sensitivity troponin was 124.9±81.4 ng/L in the direct TAVR group versus 170.4±127.7 ng/L in the BAV group (P=0.007). Myocardial injury occurred in 42 patients (19.9%), including 13 patients (12.2%) in the direct TAVR group and 29 (27.9%) in the BAV group (P=0.004). BAV increased by 2.8‐fold (95% CI, 1.4–5.8) myocardial injury probability. Myocardial injury was associated with 1‐month adverse events (P=0.03).ConclusionsBAV increased the incidence and magnitude of myocardial injury after TAVR with new‐generation balloon‐expandable valves. Myocardial injury was associated with 1‐month adverse events. These results argue in favor of direct SAPIEN 3 valve implantation.
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