Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement
| Autor: | Nicolas Nagot, Grégory Marin, Gilles Levy, Benoit Lattuca, Laurent Schmutz, François Roubille, Gabriel Robert, Eric Maupas, Marine Chettouh, Delphine Delseny, Florence Leclercq, Mariama Akodad, Thomas Gandet, Frederic Targosz, Jean-Christophe Macia, Pierre Robert, Guillaume Cayla, Bernard Albat |
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| Přispěvatelé: | Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), 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), Institut de Génomique Fonctionnelle (IGF), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Comportement et noyaux gris centraux = Behavior and Basal Ganglia [Rennes], Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes = Institute of Clinical Neurosciences of Rennes (INCR), Clinique du Millénaire - Oc Santé [Montpellier], Oc Santé [Montpellier], Centre Hospitalier Saint Jean de Perpignan, Hôpital des Franciscaines, Pathogénèse et contrôle des infections chroniques (PCCI), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Service de chirurgie thoracique et cardio-vasculaire, Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Arnaud de Villeneuve-Université de Montpellier (UM), Edwards Lifesciences, Université de Montpellier (UM)-Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Montpellier 2 - Sciences et Techniques (UM2)-Centre National de la Recherche Scientifique (CNRS), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre Hospitalier Universitaire de Montpellier (CHU Montpellier ), MORNET, Dominique, Université de Rennes (UR)-Université européenne de Bretagne - European University of Brittany (UEB)-CHU Pontchaillou [Rennes]-Institut des Neurosciences Cliniques de Rennes (INCR) |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Aortic valve
medicine.medical_specialty [SDV.MHEP.CHI] Life Sciences [q-bio]/Human health and pathology/Surgery medicine.medical_treatment Regurgitation (circulation) [SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery 030204 cardiovascular system & hematology Balloon law.invention 03 medical and health sciences 0302 clinical medicine Valve replacement Randomized controlled trial [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system law Internal medicine device success medicine Clinical endpoint direct implantation 030212 general & internal medicine business.industry randomized clinical trial Confidence interval [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system Aortic valvuloplasty medicine.anatomical_structure balloon aortic valvuloplasty Cardiology transcatheter aortic valve replacement Cardiology and Cardiovascular Medicine business |
| Zdroj: | JACC: Cardiovascular Interventions JACC: Cardiovascular Interventions, 2020, 13 (5), pp.594-602. ⟨10.1016/j.jcin.2019.12.006⟩ JACC: Cardiovascular Interventions, Elsevier/American College of Cardiology, 2020, 13 (5), pp.594-602. ⟨10.1016/j.jcin.2019.12.006⟩ |
| ISSN: | 1936-8798 |
| DOI: | 10.1016/j.jcin.2019.12.006⟩ |
| Popis: | International audience; Objectives: The aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV).Background: Randomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV.Methods: DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty. The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events.Results: Device success was recorded for 184 of 236 included patients (78.0%). The rate of device success in the direct implantation group (n = 97 [80.2%]) was noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: −4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 19.0% in the direct implantation group; p = 0.70). No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation.Conclusions: Direct TAVR without prior BAV was noninferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification. BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519) |
| Databáze: | OpenAIRE |
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