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1. Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients: The FRANCE-2 Registry

Author

Gilard, Martine, Eltchaninoff, Hélène, Donzeau Gouge, Patrick, Chevreul, Karine, Fajadet, Jean, Leprince, Pascal, Leguerrier, Alain, Lievre, Michel, Prat, Alain, Teiger, Emmanuel, Lefevre, Thierry, Tchetche, Didier, Didier, Didier, Himbert, Dominique, Albat, Bernard, Cribier, Alain, Sudre, Arnaud, Blanchard, Didier, Rioufol, Gilles, Collet, Frederic, Houel, Remi, Dos Santos, Pierre, Meneveau, Nicolas, Ghostine, Said, Manigold, Thibaut, Guyon, Philippe, Grisoli, Dominique, Le Breton, Herve, Delpine, Stephane, Favereau, Xavier, Souteyrand, Geraud, Ohlmann, Patrick, Doisy, Vincent, Grollier, Gilles, Gommeaux, Antoine, Claudel, Claude, Bourlon, Francois, Bertrand, Bernard, Laskar, Marc, Iung, Bernard, Bertrand, Michel, Cassagne, Jean, Boschat, Jacques, Lusson, Jean, Mathieu, Pierre, Logeais, Yves, Bessou, Jean-Paul, Chevalier, Bernard, Farge, Arnaud, Garot, Philippe, Hovasse, Thomas, Morice, Claude, Romano, Mauro, Vahdat, Olivier, Farah, Bruno, Carrie, Didier, Dumonteil, Nicolas, Fournial, Gérard, Bertrand, Marc, Nataf, Patrick, Vahanian, Alec, Leclercq, Florence, Piot, Christophe, Schmutz, Laurent, Aubas, Pierre, du Cailar, A., Dubar, A., Durrleman, N., Fargosz, F., Levy, Gilles, Maupas, Eric, Rivalland, François, Robert, G., Tron, Christophe, Juthier, Francis, Modine, Thomas, Van Belle, Eric, Banfi, Carlo, Sallerin, Thierry, Bar, Olivier, Barbey, Christophe, Chassaing, Stephan, Chatel, Didier, Le Page, Olivier, Tauran, Arnaud, Cao, Daniele, Dauphin, Raphael, Durand de Gevigney, Guy, Finet, Gérard, Jegaden, Olivier, Obadia, François, Beygui, Farzin, Collet, Jean-Philippe, Pavie, Alain, Vaillant, Alain, Vicat, Jacques, Wittenberg, Olivier, Joly, Patrick, Rosario, Roger, Bergeron, Patrice, Bille, Jacques, Gelisse, Richard, Couetil, Jean-Paul, Dubois Rande, Jean-Luc, Hayat, Delphine, Fougeres, Emilie, Monin, Jean-Luc, Mouillet, Gauthier, Arsac, Florence, Choukroun, Emmanuel, Dijos, Marina, Guibaud, Jean-Philippe, Leroux, Lionel, Elia, Nicolas, Chocron, Sidney, Schiele, François, Caussin, Christophe, Azmoun, Alexandre, Nottin, Rémi, Tirouvanziam, Ashok, Crochet, Dominique, Gaudin, Régis, Roussel, Jean-Christian, Bonnet, Nicolas, Digne, Franck, Mesnidrey, Patrick, Royer, Thierry, Stratiev, Victor, Bonnet, Jean-Louis, Cuisset, Thomas, Abouliatim, Issal, Bedossa, Marc, Boulmier, Dominique, Verhoye, Philippe, Delepine, Stéphane, Debrux, Jean-Louis, Furber, Alain, Pinaud, Frédéric, Bezon, Eric, Choplain, Jean-Noel, Bical, Oliver, Dambrin, Grégoire, Deleuze, Philippe, Jegou, Arnaud, Lusson, Jean-René, Azarnouch, Kasra, Durel, Nicolas, Innorta, Andrea, Lienhart, Yves, Roriz, Ricardo, Staat, Patrick, Fabiani, Jean-Noël, Lafont, Antoine, Zegdi, Rachid, Heudes, Didier, Kindo, Michel, Mazzucotelli, Jean-Philippe, Zupan, Michel, Ivascau, Calin, Lognone, Thérèse, Massetti, Massimo, Sabatier, Rémy, Huret, Bruno, Hochart, Philippe, Bouchayer, Damien, Gabrielle, François, Pelissier, Franck, Tremeau, Guillaume, Dreyfus, Gilles, Eker, Armand, Habib, Yakoub, Hugues, Nicolas, Mialhe, Claude, Chavanon, Olivier, Porcu, Paolo, Vanzetto, Gérald, Donzeau-Gouge, Patrick, Didier, Romain, Gommeaux, Bernard, Claudel, Jean-Philippe, Nutrition, obésité et risque thrombotique ( NORT ), Institut National de la Recherche Agronomique ( INRA ) -Aix Marseille Université ( AMU ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Nutrition, obésité et risque thrombotique (NORT), Aix Marseille Université (AMU)-Institut National de la Recherche Agronomique (INRA)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Institut National de la Recherche Agronomique (INRA)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
[SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, predictive analysis, aortic stenosis, risk score, [ SDV.MHEP.CSC ] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system
Abstract

International audience; Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up.; This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry.; The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used.; A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p

Published
2016

2. Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients The FRANCE-2 Registry

Author

Gilard, Martine, Eltchaninoff, Hélène, Donzeau-Gouge, Patrick, Chevreul, Karine, Fajadet, Jean, Leprince, Pascal, Leguerrier, Alain, Lievre, Michel, Prat, Alain, Teiger, Emmanuel, Lefèvre, Thierry, Tchetche, Didier, Carrie, Didier, Himbert, Dominique, Albat, Bernard, Cribier, Alain, Sudre, Arnaud, Blanchard, Didier, Rioufol, Gilles, Collet, Frederic, Houel, Remi, dos Santos, Pierre, Meneveau, Nicolas, Ghostine, Said, Manigold, Thibaut, Guyon, Philippe, Grisoli, Dominique, Le Breton, Hervé, Delpine, Stephane, Didier, Romain, Favereau, Xavier, Souteyrand, Geraud, Ohlmann, Patrick, Doisy, Vincent, Grollier, Gilles, Gommeaux, Antoine, Claudel, Jean-Philippe, Bourlon, Francois, Bertrand, Bernard, Laskar, Marc, Iung, Bernard, Optimisation des régulations physiologiques (ORPHY (EA 4324)), Université de Brest (UBO)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Service de cardiologie [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Nouvelles Cibles Pharmacologiques de la Protection Endothéliale et de l'Insuffisance Cardiaque (EnVI), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Cardiovasculaire Paris Sud (ICPS), APHP URC-Eco Ile de Frabce, Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables (ECEVE (U1123 / UMR_S_1123)), Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris]-Université Paris Diderot - Paris 7 (UPD7), Clinique Pasteur, Clinique Pasteur [Toulouse], Service de chirurgie cardiaque et thoracique [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], Service de chirurgie thoracique cardiaque et vasculaire [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Evaluation et modélisation des effets thérapeutiques, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Département de physiologie (CHU Henri Mondor), Hôpital Henri Mondor, Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Service de cardiologie, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Service de cardiologie [Toulouse], Hôpital de Rangueil, CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse], Institut de médecine moléculaire de Rangueil (I2MR), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-IFR150-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut des Maladies Métaboliques et Cardiovasculaires (I2MC), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Diderot - Paris 7 (UPD7)-AP-HP - Hôpital Bichat - Claude Bernard [Paris]-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Service de chirurgie thoracique et cardio-vasculaire, Hôpital Arnaud de Villeneuve-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université Montpellier 1 (UM1)-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Pôle Cardiologie Interventionnelle / Coro-scanner / IRM Cardiaque, Clinique Saint Gatien, Hôpital Cardiovasculaire Louis Pradel, Hospices Civils de Lyon (HCL), Université Bordeaux Segalen - Bordeaux 2, Université de Franche-Comté (UFC), Service de cardiologie et maladies vasculaires, Service de cardiologie et de pathologie vasculaire [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Service de Chirurgie Thoracique et Vasculaire - Médecine vasculaire [CHU Limoges], CHU Limoges, Equipe de Recherche Médicale Appliquée (ERMA), Université de Limoges (UNILIM)-CHU Limoges-Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503), CHU de Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), FRANCE-2 registry, Edwards Lifesciences, Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Service de Chirurgie cardiaque et thoracique [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de chirurgie thoracique cardiaque et vasculaire [Rennes] = Thoracic and Cardiovascular Surgery [Rennes], CHU Pontchaillou [Rennes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Arnaud de Villeneuve-Université de Montpellier (UM), Université Bourgogne Franche-Comté [COMUE] (UBFC), Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes], Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503)-Université de Limoges (UNILIM)-CHU Limoges, Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris], Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Hôpital de Rangueil, CHU Toulouse [Toulouse], Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Arnaud de Villeneuve, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service Cardiologie [CHU Toulouse], Pôle Cardiovasculaire et Métabolique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Université de Toulouse (UT)-Université de Toulouse (UT)- Institut Fédératif de Recherche Bio-médicale Institution (IFR150)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées- Institut Fédératif de Recherche Bio-médicale Institution (IFR150)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
corevalve, predictors, [SDV]Life Sciences [q-bio], permanent pacemaker implantation, stenosis, impact, 2-year outcomes, survival, mortality, long-term outcomes, late clinical-outcomes
Abstract

International audience; BACKGROUND Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up. OBJECTIVES This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. METHODS The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used. RESULTS A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade >= 2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in < 2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up. CONCLUSIONS The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time. (J Am Coll Cardiol 2016; 68: 1637-47) (C) 2016 by the American College of Cardiology Foundation.

Published
2016
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3. Registry of transcatheter aortic-valve implantation in high-risk patients

Author

Gilard, Martine, Eltchaninoff, Hélène, Iung, Bernard, Donzeau-Gouge, Patrick, Chevreul, Karine, Fajadet, Jean, Leprince, Pascal, Leguerrier, Alain, Lievre, Michel, Prat, Alain, Teiger, Emmanuel, Lefevre, Thierry, Himbert, Dominique, Tchetche, Didier, Carrié, Didier, Albat, Bernard, Cribier, Alain, Rioufol, Gilles, Sudre, Arnaud, Blanchard, Didier, Collet, Frederic, Dos Santos, Pierre, Meneveau, Nicolas, Tirouvanziam, Ashok, Caussin, Christophe, Guyon, Philippe, Boschat, Jacques, Le Breton, Herve, Collart, Frederic, Houel, Remi, Delpine, Stephane, Souteyrand, Geraud, Favereau, Xavier, Ohlmann, Patrick, Doisy, Vincent, Grollier, Gilles, Gommeaux, Antoine, Claudel, Jean-Philippe, Bourlon, Francois, Bertrand, Bernard, Van Belle, Eric, Laskar, Marc, Renseigné, Non, Optimisation des régulations physiologiques (ORPHY (EA 4324)), Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Service de cardiologie, Université Paris Diderot - Paris 7 (UPD7)-AP-HP - Hôpital Bichat - Claude Bernard [Paris]-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Service d'Hématologie Clinique [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], Service de chirurgie thoracique cardiaque et vasculaire [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Evaluation et modélisation des effets thérapeutiques, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Service de cardiologie [Toulouse], Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Hôpital de Rangueil, CHU Toulouse [Toulouse], Service de chirurgie thoracique et cardio-vasculaire, Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Arnaud de Villeneuve, Service de cardiologie [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Hôpital Cardiovasculaire Louis Pradel, Hospices Civils de Lyon (HCL), Université Bordeaux Segalen - Bordeaux 2, unité de recherche de l'institut du thorax UMR1087 UMR6291 (ITX), Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Neurosciences Sensorielles Comportement Cognition, Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon, Interface sang vaisseaux et réparation cardiovasculaire, Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Service de Chirurgie Thoracique et Vasculaire - Médecine vasculaire [CHU Limoges], CHU Limoges, Université de Limoges (UNILIM), Equipe de Recherche Médicale Appliquée (ERMA), Université de Limoges (UNILIM)-CHU Limoges-Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503), Université de Brest (UBO)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Service d'Hématologie clinique [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de chirurgie thoracique cardiaque et vasculaire [Rennes] = Thoracic and Cardiovascular Surgery [Rennes], CHU Pontchaillou [Rennes], Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Arnaud de Villeneuve-Université de Montpellier (UM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service Cardiologie [CHU Toulouse], Pôle Cardiovasculaire et Métabolique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Unité de recherche de l'institut du thorax (ITX-lab), Université Paris Diderot - Paris 7 (UPD7)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital de Rangueil, CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse], Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-IFR10, and Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503)-Université de Limoges (UNILIM)-CHU Limoges

Subjects
Male, Cardiac Catheterization, MESH: Registries, medicine.medical_treatment, Periprosthetic, 030204 cardiovascular system & hematology, 0302 clinical medicine, MESH: Aged, 80 and over, Prospective Studies, Registries, 030212 general & internal medicine, MESH: Incidence, Settore MED/23 - CHIRURGIA CARDIACA, Prospective cohort study, Stroke, MESH: Aortic Valve Stenosis, Cardiac catheterization, Aged, 80 and over, Heart Valve Prosthesis Implantation, MESH: Aged, High risk patients, Framingham Risk Score, MESH: Cardiac Catheterization, Incidence, General Medicine, 3. Good health, Heart Valve Prosthesis, Aortic valve stenosis, Cardiology, Female, France, MESH: Hemorrhage, Medtronic corevalve, MESH: Heart Valve Prosthesis Implantation, medicine.medical_specialty, Transcatheter aortic, MESH: Heart Valve Prosthesis, Hemorrhage, MESH: Multivariate Analysis, MESH: Stroke, 03 medical and health sciences, Internal medicine, medicine, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Humans, Aged, MESH: Humans, business.industry, EuroSCORE, Aortic Valve Stenosis, medicine.disease, MESH: Prospective Studies, MESH: Male, Surgery, MESH: France, Stenosis, Multivariate Analysis, business, MESH: Female
Abstract

International audience; BACKGROUND: Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2. METHODS: All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause. RESULTS: A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival. CONCLUSIONS: This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).

Published
2012
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4. Percutaneous balloon atrioseptostomy for left heart discharge in extracorporeal life support patients with persistent pulmonary edema

Author

Bignon, Mathieu, Roule, Vincent, Dahdouh, Ziad, Sabatier, Rémi, Lognoné, Thérèse, Malcor, Guillaume, Idali, Moussa, Ivascau, Calin, Massetti, Massimo, and Grollier, Gilles

Subjects
Adult, Male, Extracorporeal Circulation, Adolescent, Angioplasty, Coronary, Pulmonary Edema, Middle Aged, Femoral Artery, Life Support Care, Young Adult, Treatment Outcome, Nuclear Medicine and Imaging, Humans, Female, Angioplasty, Balloon, Coronary, Cardiology and Cardiovascular Medicine, Radiology, Settore MED/23 - CHIRURGIA CARDIACA, Cardiomyopathies, Balloon, Retrospective Studies, Radiology, Nuclear Medicine and Imaging
Abstract

In severe myocardial dysfunction, extracorporeal life support (ECLS) can preserve organ perfusion. Occasionally, the high resulting afterload can lead to refractory pulmonary edema. We report our experience with percutaneous balloon atrioseptostomy used in this circumstance to discharge the left heart and prevent worsening pulmonary congestion.Between October 2002 and December 2009, 5 patients, with a mean age of 39 years, who were under peripheral ECLS underwent percutaneous balloon atrioseptostomy for refractory worsening pulmonary edema as determined by clinical, radiological, and echocardiographic criteria. Myocardial dysfunction was related to drug poisoning in 2 cases and to myocarditis in the 3 others. Atrioseptostomy successfully improved pulmonary edema and echocardiographic indices of left ventricular function in all cases. Four patients were eventually discharged. The fifth patient died in hospital due to multiorgan failure.In our experience, percutaneous balloon atrioseptostomy appeared to be a rapid, effective, and minimally invasive technique for offloading the left heart of patients with a reversible cardiac dysfunction under ECLS and suffering from refractory pulmonary edema.

Published
2011

5. Recombinant hirudin (lepirudin) for the improvement of thrombolysis with streptokinase in patients with acute myocardial infarction Results of the HIT-4 trial

Author

Neuhaus, Karl-Ludwig, Molhoek, G.Peter, Zeymer, Uwe, Tebbe, Ulrich, Wegscheider, Karl, Schröder, Rolf, Camez, Anne, Laarman, G.Jan, Grollier, Gilles M, Lok, Dirk J.A, Kuckuck, Holger, and Lazarus, Peter

Abstract

OBJECTIVESThe purpose of this study was to compare recombinant hirudin and heparin as adjuncts to streptokinase thrombolysis in patients with acute myocardial infarction (AMI).BACKGROUNDExperimental studies and previous small clinical trials suggest that specific thrombin inhibition improves early patency rates and clinical outcome in patients treated with streptokinase.METHODSIn a randomized double-blind, multicenter trial, 1,208 patients with AMI ≤6 h were treated with aspirin and streptokinase and randomized to receive recombinant hirudin (lepirudin, IV bolus of 0.2 mg/kg, followed by subcutaneous (SC) injections of 0.5 mg/kg b.i.d. for 5 to 7 days) or heparin (IV placebo bolus, followed by SC injections of 12,500 IU b.i.d. for 5 to 7 days). A total of 447 patients were included in the angiographic substudy in which the primary end point, 90-min Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 of the infarct-related artery, was evaluated, while the other two-thirds served as “safety group” in which only clinical end points were evaluated. As an additional efficacy parameter the ST-segment resolution at 90 and 180 min was measured in all patients.RESULTSTIMI flow grade 3 was observed in 40.7% in the lepirudin and in 33.5% in the heparin group (p = 0.16), respectively. In the entire study population the proportion of patients with complete ST resolution at 90 min (28% vs. 22%, p = 0.05) and at 180 min (52% vs. 48%, p = 0.18) after start of therapy tended to be higher in the lepirudin group. There was no significant difference in the incidence of hemorrhagic stroke (0.2% vs. 0.3%) or total stroke (1.2% vs. 1.5%), reinfarction rate (4.6% vs. 5.1%) and total mortality rate (6.8% vs. 6.4%) at 30 days, as well as the combined end point of death, nonfatal stroke, nonfatal reinfarction, rescue-percutaneous transluminal coronary angioplasty and refractory angina (22.7 vs. 24.3%) were not statistically different between the two groups.CONCLUSIONSLepirudin as adjunct to thrombolysis with streptokinase did not significantly improve restoration of blood flow in the infarct vessel as assessed by angiography, but was associated with an accelerated ST resolution. There was no increase in the risk of major bleedings with lepirudin compared to heparin.

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