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1. Aortic root surgery with the CARDIOROOT vascular graft: results of a prospective multicenter post-market surveillance study

Author

Giordano Tasca, Jaroslav Lindner, Laurent Barandon, Petr Santavy, Carlo Antona, Jan Burkert, and Amando Gamba

Subjects
Aortic root surgery, Vascular graft, Sinus of Valsalva, CARDIOROOT, Surgery, RD1-811, Anesthesiology, RD78.3-87.3
Abstract

Abstract Background Sparing Aortic Valve procedure requires to reproduction of the geometry of the physiologic anatomy of the aortic root. Thus, the materials adopted may make a difference. CARDIOROOT is a one-piece collagen-coated woven vascular graft with pseudo-sinuses, which was designed for use in the treatment of aortic root disease. We report the results of a prospective, multicenter, observational post-market surveillance study evaluating the safety and performance of the CARDIOROOT in patients requiring aortic root surgery. Methods Patients with aortic root disease suitable for treatment with a vascular graft with pseudo-sinuses CARDIOROOT graft were eligible for participation. The enrolled patients were assessed intraoperatively, post-operatively, at discharge and at 1-year. Sites assessed complications at each visit, and recorded any reported adverse events. The study endpoint was mortality and complications through 1-year post-procedure. Results Fifty-two patients were enrolled from 6 European centers. All procedures were technically successful. Operative mortality was 1.9%: one patient suffered hemorrhagic shock unrelated to the graft 1 day following surgery. At 1-year follow-up the survival rate was 96.2%, with a late death due to pneumonia 5 months post-procedure. Eleven serious adverse events occurred in 7 patients, which included cardiac complications (pericardial effusion, myocardial infarction and ventricular arrhythmia), infection (pericardial infection, deep sternal infection and superficial sternal infection), vascular disorders, including hemorrhagic shock and pleural effusion requiring drainage. Nine of the 11 events were deemed procedure-related by the local investigator, and all were deemed unrelated to the device. There were no reports of graft-related adverse events, infection, occlusion or graft failure. Conclusions The results of this 1-year follow-up study showed that the CARDIOROOT vascular graft is safe and effective for the treatment of aneurysmal aortic root in immediate and mid-term follow-up. However, longer term follow-up is needed before conclusions can be made on the long-term safety and effectiveness. Trial registration ClinicalTrials.gov Identifier: NCT01609270. Registered 31 May 2012.

Published
2019
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2. Cardiac Resynchronization Therapy Reduces Metaboreflex Contribution to the Ventilatory Response in Heart Failure Population

Author

Jérémie Jaussaud, Laurie Aimable, Pierre Bordachar, Pierre Dos Santos, Laurent Barandon, Philippe Ritter, Raymond Roudaut, and Hervé Douard

Subjects
Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background. Metaboreflex overactivation has been proprosed to explain exaggerated hyperventilation in heart failure population. We investigated the metaboreflex activation after cardiac resynchronization therapy (CRT). Methods. 10 heart failure patients (mean left ventricular ejection fraction (LVEF) 27±4%) schedulded for CRT implantation were prospectively studied. At baseline and after 6 month follow up two maximal cardiopulmonary exercise tests with and without regional circulatory occlusion (RCO) during recovery were performed. RCO was achieved by inflation of bilateral upper thigh tourniquets 30 mmHg above peak systolic blood pressure during 3 minutes after peak exercise. Metaboreflex contribution to the ventilatory response was assessed as the difference in ventilatory data at the third minute during recovery between the two tests (Δ). Results. Patients had enhanced VE/VCO2 slope (40±9) and an evident metaboreflex contribution to the high ventilatory response (ΔVE: 3±4 L/min; 𝑃=0.05, ΔRR: 4.5±4/min; 𝑃=0.003 and ΔVE/VCO2: 5.5±4; 𝑃=0.007). 6 months after CRT implantation, NYHA class, LVEF, peak VO2 and VE/VCO2 were significantly improved (1.4±0.5; 𝑃

Published
2012
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3. Adjustment and Characterization of an Original Model of Chronic Ischemic Heart Failure in Pig

Author

Laurent Barandon, Joachim Calderon, Patricia Réant, Dominique Caillaud, Stéphane Lafitte, Xavier Roques, Thierry Couffinhal, and Pierre Dos Santos

Subjects
Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

We present and characterize an original experimental model to create a chronic ischemic heart failure in pig. Two ameroid constrictors were placed around the LAD and the circumflex artery. Two months after surgery, pigs presented a poor LV function associated with a severe mitral valve insufficiency. Echocardiography analysis showed substantial anomalies in radial and circumferential deformations, both on the anterior and lateral surface of the heart. These anomalies in function were coupled with anomalies of perfusion observed in echocardiography after injection of contrast medium. No demonstration of myocardial infarction was observed with histological analysis. Our findings suggest that we were able to create and to stabilize a chronic ischemic heart failure model in the pig. This model represents a useful tool for the development of new medical or surgical treatment in this field.

Published
2010
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4. Left ventricle reconstruction and heartmate3 implantation. The 'double patch technique'

Author

Alexandre Metras, Mathieu Pernot, Louis Labrousse, Laurent Barandon, Julien Peltan, Waleed Albadi, Gregory Kalscheuer, Antonio Piperata, Gino Gerosa, Tomaso Bottio, UCL - SSS/IREC/MONT - Pôle Mont Godinne, and UCL - (MGD) Service de chirurgie cardio-vasculaire et thoracique

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Bovine pericardium, Heart Ventricles, medicine.medical_treatment, cardiovascular pathology, 030204 cardiovascular system & hematology, cardiovascular research, Prosthesis Design, giant ventricular aneurysm, Ventricular geometry, Prosthesis Implantation, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Animals, Humans, cardiovascular diseases, Cardiac Surgical Procedures, Heart Aneurysm, Heart Failure, Thrombotic risk, Bridge to transplant, business.industry, Plastic Surgery Procedures, medicine.disease, medicine.anatomical_structure, 030228 respiratory system, Ventricle, Ventricular assist device, Heart failure, Cardiology, cardiovascular system, Cattle, Surgery, Heart-Assist Devices, Cardiology and Cardiovascular Medicine, business, Destination therapy
Abstract

Background HeartMate 3 is a left ventricular assist device, composed of a centrifugal pump. It can be applied as a myocardial recovery, a bridge to transplant, or a destination therapy, in the treatment of patients with left ventricular heart failure. Methods Herein we describe a technique applied against a giant aneurysmal dilatation, which combines a surgical device implantation and a left ventricular reconstruction using a double patch. Results The patch minimizes thrombotic risk thanks to its internal bovine pericardium layer, which is in contact with blood. Conclusions The outlined technique is relatively reproducible and safe in a selected group of patients, as it employs a high-quality device and enables the restoration of an appropriate ventricular geometry.

Published
2020

5. Early Ventricular Arrhythmias After LVAD Implantation Is the Strongest Predictor of 30-Day Post-Operative Mortality

Author

Vincent Auffret, Walid Ghodbane, Stéphane Boulé, Annette Belin, Michel Kindo, Nicolas Jacob, Romain Eschalier, Gerard Babatasi, Mathieu Pernot, Philippe Rouvière, Fabien Garnier, Frédéric Anselme, Christophe Leclercq, Anne Rollin, Philippe Gaudard, Edeline Pelcé, David Hamon, Nicolas Lellouche, Thomas Senage, Jean-François Obadia, Nicolas D'Ostrevy, Arnaud Savouré, André Vincentelli, Olivier Chavanon, Marie-Cécile Bories, Vincent Galand, Vlad Gariboldi, Raphaël P. Martins, Matteo Pozzi, Erwan Flecher, Laurent Barandon, Pascal Defaye, Jean-Philippe Verhoye, Thierry Bourguignon, Camille Pichard, Hugues Blangy, Constance Verdonk, Thomas Cardi, Bertrand Pierre, Eloi Marijon, Fabrice Vanhuyse, Marie Bielefeld, Pierre Mondoly, Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Univ Rennes, Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes], CHU Pontchaillou [Rennes], Department of Cardiology and Cardiac Surgery, CHU Lille, Institut Coeur-Poumons, Lille, France, Service Cardiologie [CHU Toulouse], Pôle Cardiovasculaire et Métabolique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Hôpital Cardiologique du Haut-Lévêque, Université Bordeaux II, Bordeaux, France, Department of Cardiovascular Surgery, Hôpitaux Universitaires de Strasbourg, Strasbourg, France, Centre Hospitalier Régional Universitaire de Strasbourg (CHRU de Strasbourg), 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), 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), Department of Anesthesiology and Critical Care Medicine, Centre hospitalier universitaire de Nantes (CHU Nantes), Cardiac Stimulation and Rhythmology, CHU Grenoble, Department of Cardiology and Cardiovascular Surgery, CHU Michallon, Grenoble, France, Hospital Bichat Paris, Department of Cardiology and Cardiac Surgery, Bichat-Hospital, Paris, France, Hôpital de la Timone [CHU - APHM] (TIMONE), Department of Cardiac Surgery, 'Louis Pradel' Cardiologic Hospital, Lyon, France, Service de cardiologie [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Service de chirurgie cardio-vasculaire et thoracique (CHU Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Hôpital Henri Mondor, Service de cardiologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Department of Cardiology and Cardiac Surgery, Tours University Hospital, Tours, France, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Service de Cardiologie Maladies Vasculaires [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, CHU Clermont-Ferrand, Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Cardiology Department, European Georges Pompidou Hospital, Paris, France, Service de cardiologie pédiatrique [CHU Necker], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Chirurgie Cardiaque et Transplantations - Hôpital Brabois, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Service de Cardiologie [CHRU Nancy], Service de chirurgie thoracique cardiaque et vasculaire [Rennes] = Thoracic and Cardiovascular Surgery [Rennes], Fédération Française de Cardiologie, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Cardiology, Department of Cardiac Surgery, CHU de Toulouse, Toulouse, France, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Université de Rouen Normandie (UNIROUEN), and Normandie Université (NU)-Normandie Université (NU)-CHU Rouen

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Heart Ventricles, [SDV]Life Sciences [q-bio], Discharged alive, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Postoperative Complications, Internal medicine, medicine, left ventricular assist device, Humans, Post operative mortality, Clinical significance, 030212 general & internal medicine, post-operative mortality, Aged, Retrospective Studies, ventricular arrhythmia, Heart Failure, Ejection fraction, business.industry, Incidence (epidemiology), Arrhythmias, Cardiac, Middle Aged, medicine.disease, 3. Good health, Heart failure, Ventricular assist device, Ventricular fibrillation, Cardiology, Female, Heart-Assist Devices, business
Abstract

International audience; Objectives - This study aimed to evaluate incidence, clinical significance, and predictors of early ventricular arrhythmias (VAs) in left ventricular assist device (LVAD) recipients. Background - LVAD implantation is increasingly used in patients with end-stage heart failure. Early VAs may occur during the 30-day post-operative period, but many questions remain unanswered regarding their incidence and clinical impact. Methods - This observational study was conducted in 19 centers between 2006 and 2016. Early VAs were defined as sustained ventricular tachycardia and/or ventricular fibrillation occurring

Published
2019
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6. Risk factors and prognostic impact of left ventricular assist device–associated infections

Author

Marylou Para, Vincent Veniard, Louis Bernard, Vincent Auffret, Stéphane Boulé, Constance Verdonk, Laurent Barandon, Michel Kindo, Thierry Bourguignon, Pascal Defaye, Marie Bielefeld, David Hamon, Edeline Pelcé, Pierre Tattevin, Jérôme Jouan, Fabien Garnier, Philippe Gaudard, Pierre-Yves Litzler, Christophe Leclercq, Fabrice Vanhuyse, Nicolas Lellouche, Thomas Senage, Clément Delmas, Emilie Varlet, Thomas Cardi, Vlad Gariboldi, Daniel Grinberg, André Vincentelli, Arnaud Savouré, Erwan Flecher, Annette Belin, Nicolas Jacob, Gerard Babatasi, Philippe Rouvière, Romain Eschalier, Olivier Chavanon, Hugues Blangy, Camille Dambrin, Raphaël P. Martins, Matteo Pozzi, Nicolas D'Ostrevy, Vincent Galand, MORNET, Dominique, Service des maladies infectieuses et réanimation médicale [Rennes] = Infectious Disease and Intensive Care [Rennes], CHU Pontchaillou [Rennes], Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes], Centre Hospitalier Universitaire de Lille (CHU de Lille), Service Chirurgie Cardio-Vasculaire [CHU Toulouse] (CCV), Pôle Cardiovasculaire et Métabolique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Equipe 'Obésité et insuffisance cardiaque: approches moléculaires et cliniques ', Institut des Maladies Métaboliques et Cardiovasculaires (I2MC), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Adaptation cardiovasculaire à l'ischemie, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Bordeaux II, Centre Hospitalier Régional Universitaire de Strasbourg (CHRU de Strasbourg), 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 Nantes (CHU Nantes), Centre Hospitalier Universitaire [Grenoble] (CHU), Hôpital Michallon, Hospital Bichat Paris, Hospital,Bichat- Paris, Hôpital de la Timone [CHU - APHM] (TIMONE), Département de Chirurgie Cardiaque [Hôpital de la Timone - APHM], Hôpital Louis Pradel [CHU - HCL], Hospices Civils de Lyon (HCL), Service de cardiologie [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Service de chirurgie cadiovasculaire et thoracique [Rouen], Hôpital Charles Nicolle [Rouen], Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Hôpital Henri Mondor, Service de cardiologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Hôpital Bretonneau, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Clermont-Ferrand, chirurgie cardio-vasculaire, Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Service de Chirurgie Cardiaque et Transplantations - Hôpital Brabois, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu [Nancy], French Federation of Cardiology, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Chirurgie Cardio-Vasculaire, CHU Toulouse [Toulouse]-Hôpital de Rangueil, CHU Toulouse [Toulouse], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rouen Normandie (UNIROUEN), and Normandie Université (NU)-Normandie Université (NU)-Hôpital Charles Nicolle [Rouen]-Université de Rouen Normandie (UNIROUEN)

Subjects
Male, medicine.medical_specialty, Percutaneous, Prosthesis-Related Infections, medicine.medical_treatment, Heart Ventricles, [SDV]Life Sciences [q-bio], 030204 cardiovascular system & hematology, medicine.disease_cause, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, medicine, Humans, 030212 general & internal medicine, Device Removal, Retrospective Studies, Heartmate ii, Pseudomonas aeruginosa, business.industry, Retrospective cohort study, Middle Aged, Prognosis, equipment and supplies, Cannula, 3. Good health, Icd implantation, Defibrillators, Implantable, [SDV] Life Sciences [q-bio], Staphylococcus aureus, Ventricular assist device, Catheter-Related Infections, Multivariate Analysis, Female, France, Heart-Assist Devices, Cardiology and Cardiovascular Medicine, business
Abstract

International audience; Background - Left ventricular assist device (LVAD)-associated infections may be life-threatening and impact patients' outcome. We aimed to identify the characteristics, risk factors, and prognosis of LVAD-associated infections. Methods - Patients included in the ASSIST-ICD study (19 centers) were enrolled. The main outcome was the occurrence of LVAD-associated infection (driveline infection, pocket infection, or pump/cannula infection) during follow-up. Results - Of the 652 patients enrolled, 201 (30.1%) presented a total of 248 LVAD infections diagnosed 6.5 months after implantation, including 171 (26.2%), 51 (7.8%), and 26 (4.0%) percutaneous driveline infection, pocket infection, or pump/cannula infection, respectively. Patients with infections were aged 58.7 years, and most received HeartMate II (82.1%) or HeartWare (13.4%). Most patients (62%) had implantable cardioverter-defibrillators (ICDs) before LVAD, and 104 (16.0%) had ICD implantation, extraction, or replacement after the LVAD surgery. Main pathogens found among the 248 infections were Staphylococcus aureus (n = 113' 45.4%), Enterobacteriaceae (n = 61; 24.6%), Pseudomonas aeruginosa (n = 34; 13.7%), coagulase-negative staphylococci (n = 13; 5.2%), and Candida species (n = 13; 5.2%). In multivariable analysis, HeartMate II (subhazard ratio, 1.56; 95% CI, 1.03 to 2.36; P = .031) and ICD-related procedures post-LVAD (subhazard ratio, 1.43; 95% CI, 1.03-1.98; P = .031) were significantly associated with LVAD infections. Infections had no detrimental impact on survival. Conclusions - Left ventricular assist device-associated infections affect one-third of LVAD recipients, mostly related to skin pathogens and gram-negative bacilli, with increased risk with HeartMate II as compared with HeartWare, and in patients who required ICD-related procedures post-LVAD. This is a plea to better select patients needing ICD implantation/replacement after LVAD implantation.

Published
2019
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7. Identification of Streptococcus sinensis from a patient with endocarditis using MALDI-TOF mass spectrometry, 16S rDNA- and sodA-based phylogeny

Author

Thomas Baudinet, Prune Gaillard, Gaetane Wirth, Julien Goret, Fabrice Camou, Carine Greib, Nahema Issa, Cécile Bébéar, Francis Mégraud, Olivia Peuchant, Laurent Barandon, Armelle Ménard, ProdInra, Migration, Institut National de la Recherche Agronomique (INRA), CHU Bordeaux [Bordeaux], Institut National de la Santé et de la Recherche Médicale (INSERM), and USC IHMC - Infections humaines à mycoplasmes et à chlamydiae

Subjects
Microbiology (medical), Chromatography, General Immunology and Microbiology, [SDV]Life Sciences [q-bio], General Medicine, Ribosomal RNA, Biology, 16S ribosomal RNA, MALDI-TOF Mass Spectrometry, Mass spectrometry, medicine.disease, [SDV] Life Sciences [q-bio], Matrix-assisted laser desorption/ionization, Infectious Diseases, Phylogenetics, medicine, Immunology and Allergy, Endocarditis, Identification (biology), ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
2019
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8. 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
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9. State-of-the-Art of Left Ventricular Assist Device use in France: the ASSIST-ICD registry

Author

Stéphane Boulé, Michel Kindo, Hugues Blangy, André Vincentelli, M. Pozzi, C V Verdonk, Rosana de Carvalho Cristo Martins, Laurent Fauchier, Jean-François Obadia, M. Michel, A. Belin, Olivier Bouchot, F. Sacher, P.Y. Litlzer, Vincent Galand, Erwan Flecher, Jean-Claude Deharo, Philippe Rouvière, G. Babatasi, Jean-Christian Roussel, Laurent Barandon, Romain Eschalier, E. Marijon, Christophe Leclercq, Pascal Defaye, Pierre Mondoly, Gabriel Laurent, Vlad Gariboldi, Thierry Bourguignon, Nicolas Lellouche, Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Charles Sadron (ICS), Université de Strasbourg (UNISTRA)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Réseau nanophotonique et optique, Centre National de la Recherche Scientifique (CNRS)-Université de Strasbourg (UNISTRA)-Université de Haute-Alsace (UHA) Mulhouse - Colmar (Université de Haute-Alsace (UHA))-Centre National de la Recherche Scientifique (CNRS)-Université de Strasbourg (UNISTRA)-Université de Haute-Alsace (UHA) Mulhouse - Colmar (Université de Haute-Alsace (UHA))-Matériaux et nanosciences d'Alsace (FMNGE), Institut de Chimie du CNRS (INC)-Université de Strasbourg (UNISTRA)-Université de Haute-Alsace (UHA) Mulhouse - Colmar (Université de Haute-Alsace (UHA))-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Strasbourg (UNISTRA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), IHU-LIRYC, Université Bordeaux Segalen - Bordeaux 2-CHU Bordeaux [Bordeaux], Cardiac Stimulation and Rhythmology, CHU Grenoble, Univers, Transport, Interfaces, Nanostructures, Atmosphère et environnement, Molécules (UMR 6213) (UTINAM), Institut national des sciences de l'Univers (INSU - CNRS)-Centre National de la Recherche Scientifique (CNRS)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Hôpital du Bocage, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Paris-Centre de Recherche Cardiovasculaire (PARCC - UMR-S U970), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), LyRe, Lyonnaise des Eaux, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Strasbourg (UNISTRA)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Matériaux et Nanosciences Grand-Est (MNGE), Université de Strasbourg (UNISTRA)-Université de Haute-Alsace (UHA) Mulhouse - Colmar (Université de Haute-Alsace (UHA))-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Université de Strasbourg (UNISTRA)-Université de Haute-Alsace (UHA) Mulhouse - Colmar (Université de Haute-Alsace (UHA))-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Réseau nanophotonique et optique, Université de Strasbourg (UNISTRA)-Université de Haute-Alsace (UHA) Mulhouse - Colmar (Université de Haute-Alsace (UHA))-Centre National de la Recherche Scientifique (CNRS)-Université de Strasbourg (UNISTRA)-Centre National de la Recherche Scientifique (CNRS), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre National de la Recherche Scientifique (CNRS)-Institut national des sciences de l'Univers (INSU - CNRS), Université de Strasbourg (UNISTRA)-Centre National de la Recherche Scientifique (CNRS)-Matériaux et nanosciences d'Alsace, Université de Strasbourg (UNISTRA)-Université de Haute-Alsace (UHA) Mulhouse - Colmar (Université de Haute-Alsace (UHA))-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Strasbourg (UNISTRA)-Université de Haute-Alsace (UHA) Mulhouse - Colmar (Université de Haute-Alsace (UHA))-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Réseau nanophotonique et optique, Université de Strasbourg (UNISTRA)-Université de Haute-Alsace (UHA) Mulhouse - Colmar (Université de Haute-Alsace (UHA))-Centre National de la Recherche Scientifique (CNRS)-Université de Strasbourg (UNISTRA), CHU Bordeaux [Bordeaux]-Université Bordeaux Segalen - Bordeaux 2, Université Paris Descartes - Paris 5 (UPD5)-Hôpital Européen Georges Pompidou [APHP] (HEGP), and Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
medicine.medical_specialty, business.industry, medicine.medical_treatment, 030204 cardiovascular system & hematology, medicine.disease, 03 medical and health sciences, 0302 clinical medicine, Ventricular assist device, Internal medicine, medicine, Cardiology, 030212 general & internal medicine, State (computer science), Medical emergency, Cardiology and Cardiovascular Medicine, business, ComputingMilieux_MISCELLANEOUS, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience

Published
2017
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10. Impact of Afterload Increase on Left Ventricular Myocardial Deformation Indices

Author

Pierre Dos Santos, Alexandre Ouattara, Philippe Diolez, Alexandre Metras, Annabel Reynaud, Dominique Detaille, Béatrice Jaspard-Vinassa, Laurent Barandon, Raymond Roudaut, Patricia Reant, Stephane Lafitte, CHU Bordeaux [Bordeaux], Adaptation cardiovasculaire à l'ischémie, Université de Bordeaux (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Physiology and Pharmacology, University of Salamanca, Adaptation cardiovasculaire à l'ischemie, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Biologie des maladies cardiovasculaires = Biology of Cardiovascular Diseases, Université de Bordeaux (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), IHU-LIRYC, Université Bordeaux Segalen - Bordeaux 2-CHU Bordeaux [Bordeaux], Département de cardiologie, CHU Bordeaux [Bordeaux]-Hôpital Haut-Lévêque [CHU Bordeaux], Service Anesthésie - Réanimation [Bordeaux], Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Bordeaux (UB), Universidad de Salamanca, and Boullé, Christelle

Subjects
Male, medicine.medical_specialty, Cardiac output, Swine, Blood Pressure, 030204 cardiovascular system & hematology, Left ventricular hypertrophy, Sensitivity and Specificity, Muscle hypertrophy, Contractility, Ventricular Dysfunction, Left, 03 medical and health sciences, Basal (phylogenetics), 0302 clinical medicine, Afterload, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Elastic Modulus, Internal medicine, medicine, Article CLINIQUE, Animals, Radiology, Nuclear Medicine and imaging, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, 2. Zero hunger, Ejection fraction, business.industry, Reproducibility of Results, Stroke Volume, Aortic Valve Stenosis, medicine.disease, Myocardial Contraction, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Echocardiography, cardiovascular system, Cardiology, Elasticity Imaging Techniques, Myocardial fibrosis, Stress, Mechanical, Cardiology and Cardiovascular Medicine, business
Abstract

Background Left ventricular (LV) afterload could be associated with reduced myocardial contractility. The aim of this study was to evaluate the relative impact of increased afterload on LV myocardial deformation indices in chronic aortic constriction, with regard to hypertrophy, myocardial fibrosis, and mitochondrial function, and to differentiate acute versus chronic afterload effect. Methods Young pigs underwent aortic banding ( n = 11) or sham ( n = 7) operations. Nineteen weeks later, LV morphology and systolic function, including myocardial deformation, were assessed by echocardiography before and after banding release or acute aortic constriction (in the sham group). After the animals were euthanized, mitochondrial function and LV interstitial fibrosis were assessed. Results The chronic banding group ( n = 8) presented with significant LV hypertrophy compared with the sham group ( n = 7), and longitudinal strain (LS) was significantly altered (16.9 ± 0.7% vs 20.3 ± 0.7%, P = .001) while circumferential, radial strain, and ejection fraction were not. LS abnormalities were situated mostly on the basal and mid segments and on the septal wall. There was also significantly more myocardial fibrosis in the chronic banding group compared with the sham group, while mitochondrial function was preserved. The relative contributions of hypertrophic and fibrotic remodeling and of afterload to alter global LS were 62%, and 38%, respectively. Acute aortic banding also significantly altered LS. The ratio of LS to septal wall thickness enabled differentiation between chronic and acute afterload increase (1.9 ± 0.2 in the chronic group vs 2.9 ± 0.3 in the acute group, P = .001). Conclusions LS is susceptible to both hypertrophic and fibrotic remodeling and afterload increase, particularly on the basal and mid LV segments of the septum. The ratio of LS to septal wall thickness enables differentiation of acute from chronic afterload LS alteration.

Published
2016
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11. 1083. Long-Term Prognosis of 448 Infectious Endocarditis Followed by an Endocarditis Team

Author

Marina Dijos, Claire Cornolle, Irène Machelart, Nahema Issa, Fabrice Camou, Olivia Peuchant, Gaetane Wirth, Laurent Barandon, and Carine Greib

Subjects
medicine.medical_specialty, Patient care team, business.industry, medicine.disease, Comorbidity, Term (time), Abstracts, Infectious Diseases, Oncology, Embolism, Bacterial endocarditis, B. Poster Abstracts, Heart failure, medicine, Endocarditis, Lost to follow-up, Intensive care medicine, business
Abstract

Background The management of infective endocarditis (IE) by an expert medico-surgical team through multidisciplinary consultation meetings is now recommended. While it seems clear that it can improve the short-term prognosis of patients, long-term data are still scarce. Methods All patients hospitalized between 2013 and 2017 in the three teaching hospitals of our center with an IE treated by the multidisciplinary team were followed prospectively at 1, 3, 6, and 12 months. The main objective was to determine the 1-year mortality of the entire cohort treated by the team. Results During the study, 493 patients had a certain or possible IE and the outcome at 1 year was known for 448 of them (4 lost to follow-up and 41 followed for less than 1 year): 254 had native valve IE (57%) and 194 had prosthetic valve IE (43%). The median age of IE patients was 69.3 years (155 patients were over 75 years old) and 329 (73%) were men. Healthcare-associated IE (HAIE) accounted for 47% of cases. A microorganism was isolated in 92% of cases (S. aureus = 24%), 252 patients (56%) had an embolic events and 68 (15%) had heart failure. The Charlson Median Comorbidity Index (ICC) was 5.0. Two hundred sixteen patients (48%) underwent surgery. The mortality rates at 1 month, 3 months, 6 months, and 1 year were, respectively, 14.1%, 19.0%, 23.2%, and 27.7%. The ICC at inclusion of patients who died at 1 year was 6.0 vs. 4.0 for survivors. Mortality at 1 year was significantly higher in case of HAIE (33% vs. 23%), documented S. aureus IE (39% vs. 24%), exclusive medical treatment (40% vs. 15%), and heart failure (43% vs. 25%). Conclusion While the management of IE by an endocarditis team seems to improve the short-term prognosis of IE, 1-year mortality remains high as patients are increasingly older and have severe comorbidities. Our study confirms that early prognostic factors remain in the long term and that the prognosis is better in community-acquired IE with surgery. Disclosures All authors: No reported disclosures.

Published
2018

12. Adjustment and Characterization of an Original Model of Chronic Ischemic Heart Failure in Pig

Author

Stephane Lafitte, Xavier Roques, Thierry Couffinhal, Joachim Calderon, Patricia Reant, Laurent Barandon, Dominique Caillaud, and Pierre Dos Santos

Subjects
Lv function, lcsh:Diseases of the circulatory (Cardiovascular) system, medicine.medical_specialty, Article Subject, business.industry, medicine.disease, Surgery, Contrast medium, medicine.anatomical_structure, lcsh:RC666-701, Internal medicine, Mitral valve, Cardiology, cardiovascular system, Medicine, Myocardial infarction, Circumflex, Cardiology and Cardiovascular Medicine, business, Ischemic heart, Perfusion, Artery, Research Article
Abstract

We present and characterize an original experimental model to create a chronic ischemic heart failure in pig. Two ameroid constrictors were placed around the LAD and the circumflex artery. Two months after surgery, pigs presented a poor LV function associated with a severe mitral valve insufficiency. Echocardiography analysis showed substantial anomalies in radial and circumferential deformations, both on the anterior and lateral surface of the heart. These anomalies in function were coupled with anomalies of perfusion observed in echocardiography after injection of contrast medium. No demonstration of myocardial infarction was observed with histological analysis. Our findings suggest that we were able to create and to stabilize a chronic ischemic heart failure model in the pig. This model represents a useful tool for the development of new medical or surgical treatment in this field.

Published
2010

13. Single surgical procedure combining epicardial pacemaker implantation and subsequent extraction of the infected pacing system for pacemaker-dependent patients

Author

Michel Haïssaguerre, Laurent Barandon, Louis Labrousse, Zachary I. Whinnett, Sylvain Ploux, Philippe Ritter, Sana Amraoui, Pierre Bordachar, Pierre Oses, and Arnaud Denis

Subjects
Male, Reoperation, Pulmonary and Respiratory Medicine, Pacemaker, Artificial, medicine.medical_specialty, Time Factors, Epicardial pacing, Blood Loss, Surgical, Hemodynamics, Pacemaker system, Pacemaker implantation, Postoperative Complications, Internal medicine, Cardiac tamponade, medicine, Humans, Device Removal, Aged, Aged, 80 and over, Surgical repair, business.industry, Septic shock, Cardiac Pacing, Artificial, Equipment Design, Combined procedure, Middle Aged, Staphylococcal Infections, medicine.disease, Anti-Bacterial Agents, Surgery, Treatment Outcome, Cardiology, Equipment Contamination, Feasibility Studies, Equipment Failure, Female, business, Cardiology and Cardiovascular Medicine
Abstract

Objectives Management of pacemaker infection in pacing-dependent patients is often challenging. Typically, temporary pacing is used while antibiotic therapy is given for a number of days before reimplantation of a new endocardial system. This results in a prolonged hospital stay and complications associated with temporary pacing. In this study, we examine the feasibility of performing a single combined procedure of epicardial pacemaker implantation followed by system extraction. Methods One hundred consecutive infected pacemaker-dependent patients underwent implantation of 2 epicardial ventricular leads and were converted to a ventricular demand pacing system. The infected pacing system was then extracted during the same procedure. Patients were followed up for 12 months. Results Significant pericardial bleeding developed during the procedure in 3 patients. The presence of the pericardial drain positioned during the implantation of the epicardial pacing system meant that cardiac tamponade did not occur, allowing surgical repair with sternotomy to be carried out under stable hemodynamic conditions. Two of these 100 patients died in the 30-day postoperative period; 1 death was due to septic shock and 1 to pulmonary distress. Median 1-year epicardial pacing thresholds were stable and excellent (1.4 ± 0.9 volts). However, 1 of the 2 leads developed increased thresholds in 6 patients, which led to the exclusive use of other ventricular lead. Conclusions A single combined procedure of surgical epicardial pacemaker implantation and pacemaker system extraction appears to be a safe and effective method for managing pacemaker-dependent patients with infected pacemakers.

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14. After acute coronary syndrome, diabetic patients with peripheral vascular disease remain at high risk of cardiovascular events despite secondary prevention measures

Author

Thierry Couffinhal, Henri Gin, Laurent Barandon, Xavier Pillois, Yann Pucheu, Jacques Bonnet, and Marianne Lafitte

Subjects
Male, Health Knowledge, Attitudes, Practice, medicine.medical_specialty, Acute coronary syndrome, Time Factors, Heart Diseases, Éducation thérapeutique du patient, Diabète, Drug Prescriptions, Risk Assessment, Coronary artery disease, Medication Adherence, Artériopathie périphérique, Diabetes Complications, Patient Education as Topic, Risk Factors, Internal medicine, Diabetes mellitus, medicine, Humans, Acute Coronary Syndrome, Risk factor, Aged, Proportional Hazards Models, Peripheral Vascular Diseases, Chi-Square Distribution, Prevention secondaire, Vascular disease, business.industry, Secondary prevention, Hazard ratio, Diabetes, Absolute risk reduction, Cardiovascular Agents, General Medicine, Patient education, Middle Aged, medicine.disease, Surgery, Treatment Outcome, Peripheral vascular disease, Coronaropathie, Female, business, Risk assessment, Cardiology and Cardiovascular Medicine
Abstract

Summary Background Peripheral vascular disease (PVD) is associated with a high risk of cardiovascular events after an acute coronary syndrome (ACS). The impact of suboptimal risk-factor control and drug prescription on morbidity and mortality rates in patients with PVD following an ACS remains to be established. Aims To assess whether a global atherosclerosis management programme and optimal secondary prevention could benefit high-risk PVD patients after an ACS. Methods A total of 851 ACS patients underwent an intensified intervention focusing on evaluating risk factors and atherosclerosis lesions, and on optimizing treatment and education. We compared its impact on long-term risk factors, medication observance and cardiovascular outcomes in patients with coronary artery disease (CAD) alone ( n = 715, 84.0%) and with both CAD and PVD ( n = 136). Results At a median follow-up of 18.6 months, both groups reached recommended secondary prevention goals and showed no significant differences in rates of drug prescription. PVD was not associated with minor cardiovascular events (hazard ratio [HR] 1.32, 95% confidence interval [CI] 0.57–3.02) but remained independently associated with major (HR 2.15, 95% CI 1.12–4.13) and total (HR 1.76, 95% CI 1.05–2.93) cardiovascular events. Compared to patients with CAD alone, this risk was significantly higher in CAD patients with both PVD and diabetes (HR 2.87, 95% CI 1.52–5.43), but not in PVD patients without diabetes (HR 1.35, 95% CI 0.71–2.56) or diabetic patients without PVD (HR 1.11, 95% CI 0.68–1.81). Conclusion Despite optimization of risk-factor control and drug prescription after ACS, patients with both PVD and diabetes carry a 2.9-fold higher risk of cardiovascular events at 18-month follow-up versus patients with CAD alone. This excess risk was not significant in PVD patients without diabetes or in diabetic patients without PVD.

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15. 0376: Arrhythmic storm in patients with Heart Mate® II. Incidence, risk factors and management

Author

Claire Loizeau, Pierre Dos Santos, Michel Haïssaguerre, Frederic Sacher, Joachim Calderon, Pierre Bordachar, François Picard, Laurent Barandon, Nicolas Derval, Adlane Zemmoura, Pierre Jaïs, Arnaud Denis, and Jérôme Corré

Subjects
medicine.medical_specialty, Bridge to transplant, Ejection fraction, business.industry, Incidence (epidemiology), Mortality rate, Ischaemic cardiomyopathy, Sustained ventricular tachycardia, Primary prevention, Internal medicine, medicine, Cardiology, In patient, Cardiology and Cardiovascular Medicine, business
Abstract

BackgroundRhythmic complications seem common after left ventricular (LV) assist device (LVAD), especially in the early phase of implantation (

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16. Effect of Levosimendan on Low Cardiac Output Syndrome in Patients With Low Ejection Fraction Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass

Author

Cholley, Bernard, Caruba, Thibaut, Grosjean, Sandrine, Amour, Julien, Ouattara, Alexandre, Villacorta, Judith, Miguet, Bertrand, Guinet, Patrick, Lévy, François, Squara, Pierre, Aït Hamou, Nora, Carillon, Aude, Boyer, Julie, Boughenou, Marie-Fazia, Rosier, Sebastien, Robin, Emmanuel, Radutoiu, Mihail, Durand, Michel, Guidon, Catherine, Desebbe, Olivier, Charles-Nelson, Anaïs, Menasché, Philippe, Rozec, Bertrand, Girard, Claude, Fellahi, Jean-Luc, Pirracchio, Romain, Chatellier, Gilles, Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Université Paris Descartes - Paris 5 (UPD5), Université Sorbonne Paris Cité (USPC), CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Pierre et Marie Curie - Paris 6 (UPMC), Biologie des maladies cardiovasculaires = Biology of Cardiovascular Diseases, Université de Bordeaux (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hôpital Haut-Lévêque - CHU de Bordeaux (Centre médico chirurgical Magellan), Hôpital de la Timone [CHU - APHM] (TIMONE), Hôpital Guillaume-et-René-Laennec [Saint-Herblain], CHU Pontchaillou [Rennes], Nouvel Hôpital Civil de Strasbourg, Clinique Ambroise Paré [Centres Médico-Chirurgicaux Ambroise Pré, Pierre Cherest, Hartmann], Hôpital Claude Huriez [Lille], CHU Lille, Hôpital Côte de Nacre [CHU Caen], CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), CHU Grenoble, Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital Louis Pradel [CHU - HCL], Hospices Civils de Lyon (HCL), Université Paris Descartes, Sorbonne Paris Cité, Laboratoire de Recherche Magellan, Université Jean Moulin - Lyon 3 (UJML), Université de Lyon-Université de Lyon-Institut d'Administration des Entreprises (IAE) - Lyon, Christian Latrémouille, Paul Achouh, Jérôme Jouan, Alain Bel, Jean-Noël Fabiani, Delphine Hourton, Olivier Bouchot, Adrien Bouglé, Astrid Quessard, Marwan Nader, Pascal Leprince, Delphine Hirtz, Alain Coiffic, Nathalie Noël, Cécile Poisvert, Alain Rémy, Cédric Zaouter, Louis Labrousse, Laurent Barandon, Françoise Gaillat, Catherine-Charlotte Joseph, Frédéric Collart, Nicolas Cotron, Laurent Delille, Jean-Christian Roussel, Hubert-François Carton, Laurent Daviet, Erwan Flecher, Minh Tam Hoang, Alain Brusset, Philippe Estagnaisie, Dan Longrois, Alexandre Mebazaa, Olivier Joulin, Sylvaine Robin, Géraldine Dessertaine, Myriam Cassez Brasseur, Olivier Chavanon, Fabien Dechanet, Clément Boisselier, Pierre Joseph, Olivier Bastien, Jean-François Obadia, Pascal Gueret, François Stéphan, Raphaël Porcher, and charles-nelson, anais

Subjects
[SDV] Life Sciences [q-bio], [SDV]Life Sciences [q-bio]
Abstract

International audience; Importance: Low cardiac output syndrome after cardiac surgery is associated with high morbidity and mortality in patients with impaired left ventricular function.Objective: To assess the ability of preoperative levosimendan to prevent postoperative low cardiac output syndrome.Design, setting, and participants: Randomized, double-blind, placebo-controlled trial conducted in 13 French cardiac surgical centers. Patients with a left ventricular ejection fraction less than or equal to 40% and scheduled for isolated or combined coronary artery bypass grafting with cardiopulmonary bypass were enrolled from June 2013 until May 2015 and followed during 6 months (last follow-up, November 30, 2015).Interventions: Patients were assigned to a 24-hour infusion of levosimendan 0.1 µg/kg/min (n = 167) or placebo (n = 168) initiated after anesthetic induction.Main outcomes and measures: Composite end point reflecting low cardiac output syndrome with need for a catecholamine infusion 48 hours after study drug initiation, need for a left ventricular mechanical assist device or failure to wean from it at 96 hours after study drug initiation when the device was inserted preoperatively, or need for renal replacement therapy at any time postoperatively. It was hypothesized that levosimendan would reduce the incidence of this composite end point by 15% in comparison with placebo.Results: Among 336 randomized patients (mean age, 68 years; 16% women), 333 completed the trial. The primary end point occurred in 87 patients (52%) in the levosimendan group and 101 patients (61%) in the placebo group (absolute risk difference taking into account center effect, -7% [95% CI, -17% to 3%]; P = .15). Predefined subgroup analyses found no interaction with ejection fraction less than 30%, type of surgery, and preoperative use of β-blockers, intra-aortic balloon pump, or catecholamines. The prevalence of hypotension (57% vs 48%), atrial fibrillation (50% vs 40%), and other adverse events did not significantly differ between levosimendan and placebo.Conclusions and relevance: Among patients with low ejection fraction who were undergoing coronary artery bypass grafting with cardiopulmonary bypass, levosimendan compared with placebo did not result in a significant difference in the composite end point of prolonged catecholamine infusion, use of left ventricular mechanical assist device, or renal replacement therapy. These findings do not support the use of levosimendan for this indication.Trial registration: EudraCT Number: 2012-000232-25; clinicaltrials.gov Identifier: NCT02184819.

Published
2017
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