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1. Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients

Author

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

Subjects
medicine.medical_specialty, Framingham Risk Score, Transcatheter aortic, business.industry, Incidence (epidemiology), medicine.medical_treatment, 030204 cardiovascular system & hematology, medicine.disease, 3. Good health, Surgery, 03 medical and health sciences, Stenosis, 0302 clinical medicine, Valve replacement, Aortic valve stenosis, medicine, 030212 general & internal medicine, Cardiology and Cardiovascular Medicine, Risk assessment, business, Prospective cohort study
Abstract

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 = 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

2. Temporal Trends in Transcatheter Aortic Valve Replacement in France

Author

Vincent Auffret, Thierry Lefevre, Eric Van Belle, Hélène Eltchaninoff, Bernard Iung, René Koning, Pascal Motreff, Pascal Leprince, Jean Philippe Verhoye, Thibaut Manigold, Geraud Souteyrand, Dominique Boulmier, Patrick Joly, Frédéric Pinaud, Dominique Himbert, Jean Philippe Collet, Gilles Rioufol, Said Ghostine, Olivier Bar, Alain Dibie, Didier Champagnac, Lionel Leroux, Frédéric Collet, Emmanuel Teiger, Olivier Darremont, Thierry Folliguet, Florence Leclercq, Thibault Lhermusier, Patrick Olhmann, Bruno Huret, Luc Lorgis, Laurent Drogoul, Bernard Bertrand, Christian Spaulding, Laurent Quilliet, Thomas Cuisset, Maxence Delomez, Farzin Beygui, Jean-Philippe Claudel, Alain Hepp, Arnaud Jegou, Antoine Gommeaux, Anfani Mirode, Luc Christiaens, Charles Christophe, Claude Cassat, Damien Metz, Lionel Mangin, Karl Isaaz, Laurent Jacquemin, Philippe Guyon, Christophe Pouillot, Serge Makowski, Vincent Bataille, Josep Rodés-Cabau, Martine Gilard, Hervé Le Breton, Herve Le Breton, Marc Laskar, Bernard Chevalier, Philippe Garot, Thomas Hovasse, Patrick Donzeau Gouge, Arnaud Farge, Mauro Romano, Bertrand Cormier, Erik Bouvier, Jean-Jacques Bauchart, Jean-Christophe Bodart, Cédric Delhaye, David Houpe, Robert Lallemant, Fabrice Leroy, Arnaud Sudre, Francis Juthier, Mohamed Koussa, Thomas Modine, Natacha Rousse, Jean-Luc Auffray, Marjorie Richardson, Jacques Berland, Mathieu Godin, Jean-Paul Bessou, Vincent Letocart, Jean-Christian Roussel, Philippe Jaafar, Nicolas Combaret, Nicolas D’Ostrevy, Andréa Innorta, Guillaume Clerfond, Charles Vorilhon, Marc Bedossa, Guillaume Leurent, Amedeo Anselmi, Majid Harmouche, Jean-Philippe Verhoye, Erwan Donal, Jacques Bille, Rémi Houel, Bertrand Vilette, Wissam Abi Khalil, Stéphane Delepine, Olivier Fouquet, Frédéric Rouleau, Jérémie Abtan, Marina Urena, Soleiman Alkhoder, Walid Ghodbane, Dimitri Arangalage, Eric Brochet, Coppelia Goublaire, Olivier Barthelemy, Rémi Choussat, Jean-Philippe Collet, Guillaume Lebreton, Chiro Mastrioanni, Richard Isnard, Raphael Dauphin, Olivier Dubreuil, Guy Durand De Gevigney, Gérard Finet, Brahim Harbaoui, Sylvain Ranc, Fadi Farhat, Olivier Jegaden, Jean-François Obadia, Matteo Pozzi, Saïd Ghostine, Philippe Brenot, Sahbi Fradi, Alexandre Azmoun, Philippe Deleuze, Martin Kloeckner, Didier Blanchard, Christophe Barbey, Stephan Chassaing, Didier Chatel, Olivier Le Page, Arnaud Tauran, Didier Bruere, Laurent Bodson, Yvon Meurisse, Aurélien Seemann, Nicolas Amabile, Christophe Caussin, Simon Elhaddad, Luc Drieu, Alice Ohanessian, François Philippe, Aurélie Veugeois, Matthieu Debauchez, Konstantinos Zannis, Daniel Czitrom, Chrystelle Diakov, François Raoux, Yves Lienhart, Patrick Staat, Oualid Zouaghi, Vincent Doisy, Jean Philippe Frieh, Fabrice Wautot, Julie Dementhon, Olivier Garrier, Fadi Jamal, Pierre Yves Leroux, Frédéric Casassus, Benjamin Seguy, Laurent Barandon, Louis Labrousse, Julien Peltan, Claire Cornolle, Marina Dijos, Stéphane Lafitte, Gilles Bayet, Claude Charmasson, Alain Vaillant, Jacques Vicat, Marie Paule Giacomoni, Eric Bergoend, Céline Zerbib, Jean Louis Leymarie, Philippe Clerc, Emmanuel Choukroun, Nicolas Elia, Jean-Philippe Grimaud, Jean-Philippe Guibaud, Stéphane Wroblewski, Eric Abergel, Emmanuel Bogino, Christophe Chauvel, Patrick Dehant, Marc Simon, Michel Angioi, Julien Lemoine, Simon Lemoine, Batric Popovic, Pablo Maureira, Olivier Huttin, Christine Selton Suty, Guillaume Cayla, Delphine Delseny, Gilles Levy, Jean Christophe Macia, Eric Maupas, Christophe Piot, François Rivalland, Gabriel Robert, Laurent Schmutz, Frédéric Targosz, Bernard Albat, Arnaud Dubar, Nicolas Durrleman, Thomas Gandet, Emmanuel Munos, Stéphane Cade, Frédéric Cransac, Frédéric Bouisset, Etienne Grunenwald, Bertrand Marcheix, Pauline Fournier, Olivier Morel, Patrick Ohlmann, Michel Kindo, Minh Tam Hoang, Hélène Petit, Hafida Samet, Anne Trinh, Guillaume Lecoq, Jean François Morelle, Pascal Richard, Thierry Derieux, Emmanuel Monier, Cédric Joret, Olivier Bouchot, Jean Christophe Eicher, Pierre Meyer, Stéphane Lopez, Michel Tapia, Jacques Teboul, Jean-Pierre Elbeze, Alain Mihoubi, Gérald Vanzetto, Olivier Wittenberg, Vincent Bach, Cécile Martin, Carole Sauier, Charlotte Casset, Philippe Castellant, Eric Bezon, Jean-Noel Choplain, Ahmed Kallifa, Bahaa Nasr, Yannick Jobic, Antoine Lafont, Jean-Yves Pagny, Ramzi Abi Akar, Jean-Noël Fabiani, Rachid Zegdi, Alain Berrebi, Tania Puscas, Bernard Desveaux, Fabrice Ivanes, Christophe Saint Etienne, Thierry Bourguignon, Blandine Aupy, Romain Perault, Jean-Louis Bonnet, Marc Lambert, Dominique Grisoli, Nicolas Jaussaud, Erwan Salaun, Amine Laghzaoui, Christine Savoye, Mathieu Bignon, Vincent Roule, Rémy Sabatier, Calin Ivascau, Vladimir Saplacan, Eric Saloux, Damien Bouchayer, Guillaume Tremeau, Camille Diab, Joel Lapeze, Franck Pelissier, Thomas Sassard, Catherine Matz, Nicolas Monsarrat, Ivan Carel, Franck Sibellas, Alain Curtil, Grégoire Dambrin, Xavier Favereau, Gabriel Ghorayeb, Laurent Guesnier, Wassim Khoury, Christophe Kucharski, Bruno Pouzet, Claude Vaislic, Riadh Cheikh-Khelifa, Loïc Hilpert, Philippe Maribas, Gery Hannebicque, Philippe Hochart, Marc Paris, Max Pecheux, Olivier Fabre, Laurent Leborgne, Marcel Peltier, Faouzi Trojette, Doron Carmi, Christophe Tribouilloy, Jean Mergy, Pierre Corbi, Pascale Raud Raynier, Sylvain Carillo, Arnaud Hueber, Fédéric Moulin, Georges Pinelli, Nicole Darodes, Francis Pesteil, Chadi Aludaat, Frédéric Torossian, Loïc Belle, Nicolas Chavanis, Chrystelle Akret, Alexis Cerisier, Jean Pierre Favre, Jean François Fuzellier, Romain Pierrard, Olivier Roth, Jean Yves Wiedemann, Nicolas Bischoff, Georghe Gavra, Nicolas Bourrely, Franck Digne, Mohammed Najjari, Victor Stratiev, Nicolas Bonnet, Patrick Mesnildrey, David Attias, Julien Dreyfus, Daniel Karila Cohen, Thierry Laperche, Julien Nahum, Aliocha Scheuble, Geoffrey Rambaud, Eric Brauberger, Michel Ah Hot, Philippe Allouch, Fabrice Beverelli, Julien Rosencher, Stéphane Aubert, Jean Michel Grinda, Thierry Waldman, Service de cardiologie et maladies vasculaires, Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Maladies infectieuses et vecteurs : écologie, génétique, évolution et contrôle ( MIVEGEC ), Université de Montpellier ( UM ) -Centre National de la Recherche Scientifique ( CNRS ) -Institut de Recherche pour le Développement ( IRD [France-Sud] ), Service de cardiologie [Rouen], CHU Rouen-Université de Rouen Normandie ( UNIROUEN ), Normandie Université ( NU ) -Normandie Université ( NU ), Service de cardiologie, Assistance publique - Hôpitaux de Paris (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris]-Université Paris Diderot - Paris 7 ( UPD7 ), CHU Gabriel Montpied ( CHU ), CHU Clermont-Ferrand, Institut Pascal - Clermont Auvergne ( IP ), Sigma CLERMONT ( Sigma CLERMONT ) -Université Clermont Auvergne ( UCA ) -Centre National de la Recherche Scientifique ( CNRS ), Service de chirurgie cardiaque et thoracique [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Pitié-Salpêtrière [APHP], 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 ), Service de chirurgie cardio-vasculaire et thoracique, CHU Angers, Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition ( ICAN ), CHU Pitié-Salpêtrière [APHP]-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Assistance publique - Hôpitaux de Paris (AP-HP)-Université Pierre et Marie Curie - Paris 6 ( UPMC ), Adaptation cardiovasculaire à l'ischemie, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Institut Mondor de recherche biomédicale ( IMRB ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ), Service de cardiologie [Toulouse], Université Paul Sabatier - Toulouse 3 ( UPS ) -CHU Toulouse [Toulouse]-Hôpital de Rangueil, CHU Cochin [AP-HP], 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 ), CHU de Poitiers, Epidémiologie et Biostatistique, Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps [Toulouse], Université Paul Sabatier - Toulouse 3 ( UPS ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Optimisation des régulations physiologiques ( ORPHY (EA 4324) ), Université de Brest ( UBO ) -Institut Brestois du Numérique et des Mathématiques ( IBNM ), Université de Brest ( UBO ) -Université de Brest ( UBO ), Institut de Chimie de la Matière Condensée de Bordeaux ( ICMCB ), Université de Bordeaux ( UB ) -Centre National de la Recherche Scientifique ( CNRS ), Centre Hospitalier Régional Universitaire [Lille] ( CHRU Lille ), Institut national de recherches archéologiques préventives ( Inrap ), Hémostase et pathologie cardiovasculaire, EA2693-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Lille, Droit et Santé, Belgian Institute for Space Aeronomy / Institut d'Aéronomie Spatiale de Belgique ( BIRA-IASB ), ONERA - The French Aerospace Lab ( Toulouse ), ONERA, Service de chirurgie thoracique cardiaque et vasculaire [Rennes], Institut de cardiologie [CHU Pitié-Salpêtrière], Service de Chirurgie Thoracique et Cardiovasculaire [CHU Pitié-Salpêtrière], Cardioprotection, Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Cardiovasculaire, métabolisme, diabétologie et nutrition ( CarMeN ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Hospices Civils de Lyon ( HCL ) -Institut National des Sciences Appliquées de Lyon ( INSA Lyon ), Université de Lyon-Institut National des Sciences Appliquées ( INSA ) -Université de Lyon-Institut National des Sciences Appliquées ( INSA ) -Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Institut National de la Recherche Agronomique ( INRA ), Carnegie Mellon University [Pittsburgh] ( CMU ), Hôpital nord, St Etienne, Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ), Clinique du Tonkin, Unité de recherche Phytopharmacie et Médiateurs Chimiques ( UPMC ), Institut National de la Recherche Agronomique ( INRA ), Département de cardiologie, CHU Bordeaux [Bordeaux]-Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Centre des Sciences des Littératures en Langue Française ( CSLF ), Université Paris Nanterre ( UPN ), Service de Cardiologie [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Saint-Antoine [APHP], Laboratoire de Chimie Physique - Matière et Rayonnement ( LCPMR ), Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Centre National de la Recherche Scientifique ( CNRS ), Laboratoire d'Informatique Fondamentale de Lille ( LIFL ), Université de Lille, Sciences et Technologies-Institut National de Recherche en Informatique et en Automatique ( Inria ) -Université de Lille, Sciences Humaines et Sociales-Centre National de la Recherche Scientifique ( CNRS ), Défaillance Cardiovasculaire Aiguë et Chronique ( DCAC ), Centre Hospitalier Régional Universitaire de Nancy ( CHRU Nancy ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Lorraine ( UL ), Centre Hospitalier Régional Universitaire de Nîmes ( CHRU Nîmes ), Service de chirurgie thoracique et cardio-vasculaire, Université Montpellier 1 ( UM1 ) -Centre Hospitalier Régional Universitaire [Montpellier] ( CHRU Montpellier ) -Hôpital Arnaud de Villeneuve, Institut des Maladies Métaboliques et Cardiovasculaires ( I2MC ), Université Paul Sabatier - Toulouse 3 ( UPS ) -Hôpital de Rangueil-Institut National de la Santé et de la Recherche Médicale ( INSERM ), École de sages-femmes René Rouchy ( ESF Angers ), Université d'Angers ( UA ) -CHU Angers, Laboratoire de Génie Civil et d'Ingénierie Environnementale ( LGCIE ), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon ( INSA Lyon ), Université de Lyon-Institut National des Sciences Appliquées ( INSA ) -Institut National des Sciences Appliquées ( INSA ), Agriculture and Agri-Food [Ottawa] ( AAFC ), Centre d'études et de recherche sur les contentieux - EA 3164 ( CERC ), Université de Toulon ( UTLN ), Radiopharmaceutiques biocliniques, Université Joseph Fourier - Grenoble 1 ( UJF ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Clinique de chirurgie cardiaque, Université Joseph Fourier - Grenoble 1 ( UJF ) -CHU Grenoble, Unité Mixte de Recherches sur les Herbivores ( UMR 1213 Herbivores ), VetAgro Sup ( VAS ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Recherche Agronomique ( INRA ), Université Grenoble Alpes - UFR Médecine ( UGA UFRM ), Université Grenoble Alpes ( UGA ), Développement artériel, Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Centre de recherche en économie et management ( CREM ), Université de Caen Normandie ( UNICAEN ), Normandie Université ( NU ) -Normandie Université ( NU ) -Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Centre National de la Recherche Scientifique ( CNRS ), Université Pierre et Marie Curie - Paris 6 - UFR de Médecine Pierre et Marie Curie ( UPMC ), Université Pierre et Marie Curie - Paris 6 ( UPMC ), Récepteurs nucléaires, maladies cardiovasculaires et diabète ( EGID ), Université de Lille, Droit et Santé-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Institut Pasteur de Lille, Réseau International des Instituts Pasteur ( RIIP ) -Réseau International des Instituts Pasteur ( RIIP ) -Centre Hospitalier Régional Universitaire [Lille] ( CHRU Lille ), Edwards Lifesciences Medtronic Lead-Up Medicines Company French Cardiology Federation (Federation Francaise de Cardiologie) Eli Lilly WebMD Biosensor ACIST Abbott Biosensors Terumo Daichii-Sankyo Boston Scientific St. Jude Medical Bristol-Myers Squibb Bayer AstraZeneca French Ministry of Health Abiomed Zoll Medpass Cordis Servier, Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Assistance publique - Hôpitaux de Paris (AP-HP)-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -CHU Pitié-Salpêtrière [APHP], Centre hospitalier universitaire de Poitiers ( CHU Poitiers ), Institut Pasteur de Lille, and Réseau International des Instituts Pasteur ( RIIP ) -Réseau International des Instituts Pasteur ( RIIP ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] ( CHRU Lille )

Subjects
Aortic valve, medicine.medical_specialty, medicine.medical_treatment, national registry, 030204 cardiovascular system & hematology, outcomes, 03 medical and health sciences, 0302 clinical medicine, Valve replacement, Cardiac tamponade, Medicine, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, Aortic dissection, business.industry, Mortality rate, transfemoral, EuroSCORE, [ SDV.MHEP.CSC ] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, medicine.disease, pacemaker, 3. Good health, Surgery, Stenosis, Catheter, medicine.anatomical_structure, Cardiology and Cardiovascular Medicine, business
Abstract

Background - Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited. Objectives - The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period. Methods - TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers. Results - A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p

Published
2017

3. Freedom SOLO valve: early- and intermediate-term results of a single centre's first 100 cases

Author

Nicolas Elia, Pierre Oses, Jean-Philippe Guibaud, Mathieu Pernot, Gilbert Dubois, Guillaume Lebreton, and Xavier Roques

Subjects
Pulmonary and Respiratory Medicine, Aortic valve, Adult, Male, medicine.medical_specialty, medicine.medical_treatment, Aortic Valve Insufficiency, Prosthesis Design, Pericardial effusion, Preoperative care, Aortic valve replacement, Internal medicine, Thromboembolism, medicine, Humans, Aged, Bioprosthesis, Heart Valve Prosthesis Implantation, business.industry, Platelet Count, Suture Techniques, Mitral valve replacement, Hemodynamics, Atrial fibrillation, EuroSCORE, General Medicine, Aortic Valve Stenosis, Middle Aged, medicine.disease, Septal myectomy, Surgery, medicine.anatomical_structure, Treatment Outcome, Aortic Valve, Heart Valve Prosthesis, Cardiology, Female, Cardiology and Cardiovascular Medicine, business, Epidemiologic Methods
Abstract

Objective: The Freedom SOLO aortic valve is a bovine pericardial stentless valve, which requires only one suture line. The aim of our singlecentre retrospective study was to assess postoperative and intermediate-term haemodynamic results of the first 100 consecutively implanted valves. Methods: One hundred patients (39 male and 61 female) underwent aortic valve replacement with a Freedom SOLO from November 2006 to January 2008. Their clinical, operative, platelet levels, echocardiography and follow-up data were prospectively recorded. All but two patients were available for follow-up (98% completeness), which averaged 12.6 5.06 months. Results: Associated procedures were performed in 38 patients (38%): 27 coronary artery bypass grafting (CABG), 11 mitral valve replacement, 11 septal myectomy and one ablation for atrial fibrillation. The mean age at the time of surgery was 77.2 6.43 years. The mean European System for Cardiac Operative Risk Evaluation (EuroSCORE) was 8.05 2.07. Mean cross-clamp time of isolated valve replacements was 51.27 4.7 min and 63.18 21.7 min with associated procedures. The mean implanted valve size was 23.5 1.9 mm. One patient was re-operated for bleeding, two for pericardial effusion and 39 were transfused. The overall hospital mortality was 3%. One patient died suddenly postoperatively, and a second due to a fatal atrio-ventricular block. A third patient died following a subdural bleed. Three patients required a pacemaker before hospital discharge. The overall patient survival was 97 2.26% at 1 year. Echocardiographic results preoperative, 8 days postoperative and 12 months after surgery showed mean transvalvular gradients of 50.6 15.3, 15.6 5.2 and 11.5 3.8 mm Hg, respectively, and mean left ventricular ejection fractions of 37.9 10.2%, 44 15.2% and 53.6 10.4%. Effective orifice area index for valve sizes 19, 21, 23, 25 and 27 were 0.91 0.08, 0.97 0.1, 1.08 0.07, 1.53 0.12 and 1.57 0.1 cm 2 m 2 , respectively. There were three early non-structural dysfunctions (grade 1) of regurgitation, which remained stable at 12 months. Conclusions: Freedom SOLO valve has very good early- and intermediate-term results. Short implantation times and its haemodynamic performances, particularly in small diameters, allow us to use it by first intention in older and often sicker patients. These results must be confirmed by long-term outcomes. # 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Published
2009

4. Surgical repair of an aneurysm of the innominate artery with fistulization into the trachea

Author

Xavier Roques, Nicolas Elia, Jan Remes, Jean-Philippe Guibaud, Francesco Rosato, Marie N. Laborde, Jean Dubrez, and E. Baudet

Subjects
Adult, Male, medicine.medical_specialty, Aneurysm, Right Common Carotid Artery, medicine.artery, Medicine, Humans, Brachiocephalic Trunk, Surgical repair, Vascular Fistula, Aorta, Tracheal Diseases, business.industry, Extracorporeal circulation, General Medicine, medicine.disease, Surgery, medicine.anatomical_structure, Circulatory system, cardiovascular system, Respiratory Tract Fistula, Cardiology and Cardiovascular Medicine, business, Ligation, Artery
Abstract

This report describes a 43-year-old patient presenting with an aneurysm located at the junction between the innominate artery and aorta, with spontaneous fistulization into the trachea. Emergency treatment of this unusually located lesion was undertaken to prevent intratracheal rupture. After ligation of the innominate artery, right common carotid artery, and right subclavian artery due to the risk of infection, the tracheal fistula was treated by direct closure and exclusion using an autologous pericardial flap. The procedure was performed under extracorporeal circulation and circulatory arrest with profound hypothermia.

Published
2001

5. The short- and mid-term results of bidirectional cavopulmonary shunt with additional source of pulmonary blood flow as definitive palliation for the functional single ventricular heart

Author

Maria Jimenez, Alain Choussat, Xavier Roques, Kazunori Yamada, E. Baudet, Nicolas Elia, and Marie-Nadine Laborde

Subjects
Pulmonary and Respiratory Medicine, Adult, Heart Defects, Congenital, Male, medicine.medical_specialty, Pulmonary Circulation, Time Factors, Heart disease, Adolescent, Heart Ventricles, Mid term results, medicine, Pulmonary blood flow, Humans, In patient, Derivation, Child, Survival rate, Cavopulmonary shunt, business.industry, Heart Bypass, Right, Palliative Care, Infant, Reproducibility of Results, General Medicine, Middle Aged, medicine.disease, Survival Analysis, Confidence interval, Surgery, Treatment Outcome, Child, Preschool, Female, Cardiology and Cardiovascular Medicine, business
Abstract

Objective: The purpose of this study was to demonstrate the early and late outcomes of bidirectional cavopulmonary shunt (BCPS) as a definitive procedure for the functional single ventricular heart. Method: From September 1991 to December 1997, 34 patients underwent a BCPS procedure without a routine conversion to Fontan circulation. The additional source of pulmonary blood flow was left in all patients. Conversion was performed only when it was required for excessive cyanosis. Results: The hospital mortality rate was 8.8% (3/34, 95% confidence limit; 1.9‐23%) and the 5-year survival rate was 75% for a mean follow-up period of 33 ^ 22 months. Seven patients underwent a conversion procedure for remnant or recurrent cyanosis and deterioration of exercise tolerance. Four of these patients died after conversion to Fontan circulation. Twenty-five long-term survivors with BCPSs maintained an arterial oxygen saturation of 84 ^ 6.1%, and 52% of them had a normal exercise tolerance or mild limitation. No patients developed severe late complications other than recurrent cyanosis. Conclusion: Due to the high mortality after conversion to Fontan circulation in patients whose conditions had deteriorated, we could not demonstrate the clear superiority of long-term BCPS over the construction of Fontan circulation for management of the functional single ventricular heart. If deteriorated conditions were successfully managed in the late period, the outcome of long-term BCPS would have been better. q 2000 Elsevier Science B.V. All rights reserved.

Published
2000

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