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1. Cardiac screening before returning to elite sport after SARS-CoV-2 infection

Author

Hédon, Christophe, Schnell, Frédéric, Sosner, Philippe, Chagué, Frédéric, Schuster, Iris, Julia, Marc, Duparc, Alexandre, Guy, Jean-Michel, Molinari, Nicolas, Michaux, Lionel, Cransac, Frédéric, Cade, Stéphane, Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Pontchaillou [Rennes], 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), Hôpital Hôtel-Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Laboratoire 'Mobilité, Vieillissement, Exercice' (MOVE), Université de Poitiers, Physiopathologie et épidémiologie cérébro-cardiovasculaire [Dijon] (PEC2), Université de Bourgogne (UB)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Centre Hospitalier Saint Jean de Perpignan, Hôpital Rangueil, CHU Toulouse [Toulouse], CHU Bordeaux [Bordeaux], Institut Desbrest de santé publique (IDESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Institut Montpelliérain Alexander Grothendieck (IMAG), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Médecine de précision par intégration de données et inférence causale (PREMEDICAL), Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Institut Desbrest de santé publique (IDESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Clinique du Millénaire - Oc Santé [Montpellier], Oc Santé [Montpellier], Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), and None

Subjects
Male, Adult, SARS-CoV-2, [SDV]Life Sciences [q-bio], COVID-19, Heart, General Medicine, Young Adult, Myocarditis, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Athletes, [MATH.MATH-ST]Mathematics [math]/Statistics [math.ST], Screening, Humans, Female, Cardiology and Cardiovascular Medicine, Return-to-play
Abstract

International audience; Background: SARS-CoV-2 infection can induce cardiac damage. Therefore, in the absence of clear data, a cardiac evaluation was recommended for athletes before returning to play after recent SARS-CoV-2 infection.Aim: To assess the proportion of anomalies detected by this cardiac screening.Methods: We reviewed the medical files of elite athletes referred for cardiac evaluation before returning to play after a non-hospitalized SARS-CoV-2 infection (based on a positive polymerase chain reaction or antigen test) from March 2020 to July 2021 in 12 French centres.Results: A total of 554 elite athletes (professional or national level) were included (median age 22 years, 72.0% male). An electrocardiogram (ECG), echocardiogram and exercise test were performed in 551 (99.5%), 497 (89.7%) and 293 (52.9%) athletes, respectively. We found anomalies with a potential link with SARS-CoV-2 infection in four ECGs (0.7%), three echocardiograms (0.6%) and three exercise tests (1.0%). Cardiac magnetic resonance imaging was performed in 34 athletes (6.1%), mostly due to abnormal first-line examinations, and was abnormal in one (2.9%). The rates of those abnormalities were not higher among athletes with cardiac symptoms or more severe forms of non-hospitalized SARS-CoV-2 infection. Only one athlete had a possible SARS-CoV-2 myocarditis and sport was temporally contraindicated. None had a major cardiac event declared during the follow-up.Conclusion: The proportion of cardiac involvement after non-hospitalized forms of SARS-CoV-2 infection in athletes are very low. Systematic cardiac screening before returning to play seems to be unnecessary.

Published
2022
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2. Optimization of biologics to reduce treatment failure in inflammatory bowel diseases

Author

Anne Breton, Frédérick Barreau, Emmanuel Mas, Cyrielle Gilletta De Saint-Joseph, Aurélie Bourchany, Unité de Gastroentérologie, Hépatologie, Nutrition, Diabétologie et Maladies Héréditaires du Métabolisme, Hôpital des Enfants, CHU de Toulouse, Département de Gastroentérologie, Hôpital Rangueil, CHU de Toulouse, Institut de Recherche en Santé Digestive (IRSD ), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Ecole Nationale Vétérinaire de Toulouse (ENVT), Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), CCSD, Accord Elsevier, Service Diabétologie [CHU Toulouse], Pôle Cardiovasculaire et Métabolique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Service de Gastroentérologie et pancréatologie [CHU Toulouse], and Pôle Maladies de l'appareil digestif [CHU Toulouse]

Subjects
0301 basic medicine, Drug, medicine.medical_specialty, media_common.quotation_subject, Drug Resistance, Drug resistance, Antibodies, Monoclonal, Humanized, 030226 pharmacology & pharmacy, Inflammatory bowel disease, law.invention, Efficacy, 03 medical and health sciences, 0302 clinical medicine, Gastrointestinal Agents, Randomized controlled trial, law, Drug Discovery, medicine, Humans, Treatment Failure, Intensive care medicine, media_common, Pharmacology, Biological Products, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, medicine.diagnostic_test, Tumor Necrosis Factor-alpha, business.industry, Inflammatory Bowel Diseases, medicine.disease, 3. Good health, 030104 developmental biology, Therapeutic drug monitoring, Monoclonal, Trough level, Ustekinumab, Drug Monitoring, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; Moderate to severe inflammatory bowel disease patients can fail to respond to conventional therapy and/or to biologic treatment. In the era of TNFα antagonists and other non-anti-TNF biologic drugs, it is important to review the literature on biologic treatment failure, which could be defined as primary non-response, secondary loss of response and intolerance. Therapeutic drug monitoring (TDM), that is, drug trough level and antidrug antibodies, should enable to determine the mechanisms of treatment failure and to optimize drug efficacy. There is a consensus on reactive TDM at the time of loss of response. Proactive TDM could be of interest during induction and/or maintenance, but randomized controlled trials are required.

Published
2020
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3. Correlation of Nailfold Capillaroscopy Findings with History of Digital Ulcer on Same Finger: Results of SCLEROCAP Study

Author

Carine, Boulon, Fanny, Velardo, Sophie, Blaise, Marion, Mangin, Joelle Decamps-Le, Chevoir, Patricia, Senet, Isabelle, Lazareth, Nathalie, Baudot, Laurent, Tribout, Bernard, Imbert, François-Xavier, Lapebie, Loubna, Dari, Philippe, Lacroix, Marie-Elise, Truchetet, Julien, Seneschal, Anne, Solanilla, Estibaliz, Lazaro, Isabelle, Quéré, Marc-Antoine, Pistorius, Julien, Asselineau, Edouard, Lhomme, Patrick, Carpentier, Joël, Constans, Hôpital Saint-André [CHU de Bordeaux], Institut de Santé Publique, d'Epidémiologie et de Développement (ISPED), Université Bordeaux Segalen - Bordeaux 2, Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes), Service de dermatologie et allergologie [CHU Tenon], Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Saint-Joseph, Assistance Publique-Hôpitaux de Paris, CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Rangueil, CHU Toulouse [Toulouse], Epidémiologie des Maladies Chroniques en zone tropicale (EpiMaCT), CHU Limoges-Institut d'Epidémiologie Neurologique et de Neurologie Tropicale-Institut National de la Santé et de la Recherche Médicale (INSERM)-OmégaHealth (ΩHealth), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), Service de Chirurgie Thoracique et Vasculaire - Médecine vasculaire [CHU Limoges], CHU Limoges, Service de rhumatologie, hôpital Pellegrin, CHU Bordeaux [Bordeaux], Service de dermatologie Hôpital Saint-André Bordeaux, Hôpital Haut-Lévêque [CHU de Bordeaux], Hôpital Saint Eloi, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), and Hôpital Hôtel-Dieu de Nantes - Centre Hospitalier Universitaire de Nantes (Hôpital Hôtel-Dieu de Nantes - CHU de Nantes)

Subjects
Male, Scleroderma, Systemic, Capillaroscopy, Microcirculation, Digital ulcer, Cell Biology, Biochemistry, Capillaries, Microscopic Angioscopy, Fingers, Cross-Sectional Studies, Nails, Skin Ulcer, Finger ischemia, Humans, Systemic sclerosis, Female, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Prospective Studies, Cardiology and Cardiovascular Medicine, Ulcer
Abstract

International audience; Systemic sclerosis may be complicated by digital ulcers. Nailfold capillaroscopy on one finger might reflect an increased risk of digital ulcer (DU). In the present study we studied the correlations between a history of ulcer and capillary findings on the finger.Method: This study is part of Sclerocap, a multicenter study aiming at validating prospectively the prognostic value of Maricq's and Cutolo's capillaroscopic classifications during a three-year longitudinal follow-up. A history of past or present digital ulcer was recorded at inclusion and nailfold capillaroscopy was performed. Elementary findings as well as Cutolo and Maricq's classifications were assessed.Results: 387 patients were included in Sclerocap (327 females, 60 males) and 3096 fingers were examined by capillaroscopy at inclusion: 316 fingers (10%) belonging to 113 patients had a history of DU. Late Cutolo's stage was statistically correlated with a history of DU, both by univariate: OR 2.08 [1.09-3.96] and multivariate analysis: OR 1.97 [1.06-3.63]. Among the elemental abnormalities, only edema and decreased capillary density were correlated with a history of DU by multivariate analysis: respectively OR 1.92 [1.17-3.16] and 0.65 [0.49-0.85].Conclusion: This cross-sectional study in a large cohort of patients with systemic sclerosis shows a correlation between a history of digital ulcer and edema, a decrease in capillary density and the late stage in Cutolo's classification. The extent of capillary abnormalities on one finger is associated with a history of local digital ulcer. Capillaroscopy might be used to predict the risk of DU but these results need first to be confirmed by prospective studies.

Published
2022
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4. Mitral Valve Infective Endocarditis after Trans-Catheter Aortic Valve Implantation

Author

Vassili Panagides, David del Val, Mohamed Abdel-Wahab, Norman Mangner, Eric Durand, Nikolaj Ihlemann, Marina Urena, Costanza Pellegrini, Francesco Giannini, Piotr Scislo, Zenon Huczek, Martin Landt, Vincent Auffret, Jan Malte Sinning, Asim N. Cheema, Luis Nombela-Franco, Chekrallah Chamandi, Francisco Campelo-Parada, Erika Munoz-Garcia, Howard C Herrmann, Luca Testa, Won-Keun Kim, Juan Carlos Castillo, Alberto Alperi, Didier Tchetche, Antonio L. Bartorelli, Samir Kapadia, Stefan Stortecky, Ignacio Amat-Santos, Harindra C. Wijeysundera, John Lisko, Enrique Gutiérrez-Ibanes, Vicenç Serra, Luisa Salido, Abdullah Alkhodair, Ugolino Livi, Tarun Chakravarty, Stamatios Lerakis, Victoria Vilalta, Ander Regueiro, Rafael Romaguera, Utz Kappert, Marco Barbanti, Jean-Bernard Masson, Frédéric Maes, Claudia Fiorina, Antonio Miceli, Susheel Kodali, Henrique B. Ribeiro, Jose Armando Mangione, Fabio Sandoli de Brito, Guglielmo Mario Actis Dato, Francesco Rosato, Maria-Cristina Ferreira, Valter Correia de Lima, Alexandre Siciliano Colafranceschi, Alexandre Abizaid, Marcos Antonio Marino, Vinicius Esteves, Julio Andrea, Roger R. Godinho, Fernando Alfonso, Helene Eltchaninoff, Lars Søndergaard, Dominique Himbert, Oliver Husser, Azeem Latib, Hervé Le Breton, Clement Servoz, Isaac Pascual, Saif Siddiqui, Paolo Olivares, Rosana Hernandez-Antolin, John G. Webb, Sandro Sponga, Raj Makkar, Annapoorna S. Kini, Marouane Boukhris, Philippe Gervais, Axel Linke, Lisa Crusius, David Holzhey, Josep Rodés-Cabau, Université Laval [Québec] (ULaval), Universität Leipzig [Leipzig], Technische Universität Dresden = Dresden University of Technology (TU Dresden), Endothélium, valvulopathies et insuffisance cardiaque (EnVI), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Rigshospitalet [Copenhagen], Copenhagen University Hospital, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Deutsches Herzzentrum München (DHM), Ospedale San Raffaele, Medical University of Warsaw - Poland, Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes], CHU Pontchaillou [Rennes], 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), 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), Hôpital Rangueil, CHU Toulouse [Toulouse], UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Département cardiovasculaire, Universität Leipzig, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)

Subjects
MESH: Endocarditis, Catheters, MESH: Humans, Endocarditis, MESH: Heart Valve Prosthesis, Aortic Valve Insufficiency, Aortic Valve Stenosis, MESH: Aortic Valve Insufficiency, MESH: Mitral Valve, Transcatheter Aortic Valve Replacement, Treatment Outcome, Risk Factors, MESH: Risk Factors, Aortic Valve, Heart Valve Prosthesis, Humans, Mitral Valve, [SDV.IB]Life Sciences [q-bio]/Bioengineering, MESH: Transcatheter Aortic Valve Replacement, MESH: Catheters, Cardiology and Cardiovascular Medicine, 610 Medicine & health, MESH: Aortic Valve, MESH: Aortic Valve Stenosis, MESH: Treatment Outcome
Abstract

Scarce data exist on mitral valve (MV) infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). This multicenter study included a total of 579 patients with a diagnosis of definite IE after TAVI from the IE after TAVI International Registry and aimed to evaluate the incidence, characteristics, management, and outcomes of MV-IE after TAVI. A total of 86 patients (14.9%) had MV-IE. These patients were compared with 284 patients (49.1%) with involvement of the transcatheter heart valve (THV) only. Two factors were found to be associated with MV-IE: the use of self-expanding valves (adjusted odds ratio 2.49, 95% confidence interval [CI] 1.23 to 5.07, p = 0.012), and the presence of an aortic regurgitation >= 2 at discharge (adjusted odds ratio 3.33; 95% CI 1.43 to 7.73, p < 0.01). There were no differences in IE timing and causative microorganisms between groups, but surgical management was significantly lower in patients with MV-IE (6.0%, vs 21.6% in patients with THV-IE, p = 0.001). All-cause mortality rates at 2-year follow-up were high and similar between patients with MV-IE (51.4%, 95% CI 39.8 to 64.1) and patients with THV-IE (51.5%, 95% CI 45.4 to 58.0) (log-rank p = 0.295). The factors independently associated with increased mortality risk in patients with MV-IE were the occurrence of heart failure (adjusted p < 0.001) and septic shock (adjusted p < 0.01) during the index hospitalization. One of 6 IE episodes after TAVI is localized on the MV. The implantation of a self-expanding THV and the presence of an aortic regurgitation >= 2 at discharge were associated with MV-IE. Patients with MV-IE were rarely operated on and had a poor prognosis at 2-year follow-up. (C) 2022 Elsevier Inc. All rights reserved.

Published
2022
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5. Cyclosporine before PCI in Patients with Acute Myocardial Infarction

Author

Marc Metge, Gérald Vanzetto, David Garcia-Dorado, Martine Gilard, Philippe Dubois, Fabrice Prunier, Frédéric Moulin, Thierry Unterseeh, Gilles Grollier, Marie-Claude Morice, Arnaud Sudre, Philippe Gabriel Steg, Pierre Coste, Nathan Mewton, Thien-Tri Cung, P. Staat, Fabien de Poli, Marc J. Claeys, Meier Elbaz, Inesse Boussaha, Hervé Le Breton, Jean-Luc Dubois-Randé, Cyrille Bergerot, Patrice Guerin, Pascal Motreff, Guillaume Cayla, Denis Angoulvant, Olivier Roth, Nicolas Delarche, Michel Ovize, Christophe Piot, Grégoire Rangé, Jean-François Aupetit, Magnus Hansson, Eric Bonnefoy-Cudraz, Yves Cottin, P Coussement, Paul Barragan, Thierry Beard, Loic Belle, Olivier Morel, Vincent Malquarti, Didier Blanchard, Christophe Tron, Geneviève Derumeaux, Patrice Colin, Bernard Jouve, Omar Ider, Jean-Noël Labèque, Jérôme Clerc, Eskil Elmér, Claire Jossan, Gilles Rioufol, Hôpital Arnaud de Villeneuve [CHRU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Les Hôpitaux Universitaires de Strasbourg (HUS), Université de Montpellier (UM), Hôpital Cardiovasculaire Louis Pradel, Hospices Civils de Lyon (HCL), Cellules Dendritiques, Immunomodulation et Greffes, Université de Tours (UT), Service Cardiologie [CHU Toulouse], Pôle Cardiovasculaire et Métabolique [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Department of Cardiology (Cardio - BORDEAUX), CHU Bordeaux [Bordeaux], Radiopharmaceutiques biocliniques, Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de cardiologie [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Service de cardiologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Hémostase, bio-ingénierie et remodelage cardiovasculaires (LBPC), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Institut Galilée-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Lipides - Nutrition - Cancer (U866) (LNC), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon (ENSBANA), CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Service de Cardiologie, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Laboratoire de Protection et Remodelage du Myocarde (PMRM), Université d'Angers (UA)-Université d'Angers (UA), Service de Cardiologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre hospitalier de la région d'Annecy, Centre Hospitalier Privé Beauregard. (CHPB), Centre hopitalier Privé, Optimisation des régulations physiologiques (ORPHY (EA 4324)), Université de Brest (UBO)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Institut de Génomique Fonctionnelle (IGF), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), INSERM U955, équipe 3, Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), 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), Pôle Cardiologie Interventionnelle / Coro-scanner / IRM Cardiaque, Clinique Saint Gatien, Hôpital Louis Pradel, Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Institut National de la Recherche Agronomique (INRA)-Université Claude Bernard Lyon 1 (UCBL), 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)-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM), Cardioprotection, Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Cardiology, University Hospital of Rangueil, Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Université Paris Diderot - Paris 7 (UPD7)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Diderot - Paris 7 (UPD7)-Université Paris 13 (UP13)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Galilée, Université de Montpellier (UM)-Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Montpellier 2 - Sciences et Techniques (UM2)-Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-IFR10-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-IFR10, 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), Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Institut National de la Recherche Agronomique (INRA), Hôpital Arnaud de Villeneuve, Université de Tours, Université Paris Diderot - Paris 7 (UPD7)-AP-HP - Hôpital Bichat - Claude Bernard [Paris]-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hospices Civils de Lyon (HCL), Centre Hospitalier Régional Universitaire [Montpellier] ( CHRU Montpellier ), Hospices Civils de Lyon ( HCL ), Department of Cardiology ( Cardio - BORDEAUX ), Université Joseph Fourier - Grenoble 1 ( UJF ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Service de cardiologie [Rouen], CHU Rouen-Université de Rouen Normandie ( UNIROUEN ), Normandie Université ( NU ) -Normandie Université ( NU ), Assistance publique - Hôpitaux de Paris (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris]-Université Paris Diderot - Paris 7 ( UPD7 ), Hémostase, bio-ingénierie et remodelage cardiovasculaires ( LBPC ), Université Paris Diderot - Paris 7 ( UPD7 ) -Université Paris 13 ( UP13 ) -Université Sorbonne Paris Cité ( USPC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Institut Galilée, Lipides - Nutrition - Cancer (U866) ( LNC ), Université de Bourgogne ( UB ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon ( ENSBANA ), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand ( CHU Dijon ), CHU Angers-PRES Université Nantes Angers Le Mans ( UNAM ), Laboratoire de Protection et Remodelage du Myocarde ( PMRM ), Université d'Angers ( UA ) -Université d'Angers ( UA ), Centre Hospitalier Régional Universitaire de Nancy ( CHRU Nancy ), Centre Hospitalier Privé Beauregard. ( CHPB ), 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 Génomique Fonctionnelle ( IGF ), Centre National de la Recherche Scientifique ( CNRS ) -Université Montpellier 2 - Sciences et Techniques ( UM2 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Montpellier 1 ( UM1 ) -Université de Montpellier ( UM ), Institut Mondor de Recherche Biomédicale ( IMRB ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ), 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 ), 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 ), Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Hôpital Rangueil, CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris]-Université Paris Diderot - Paris 7 (UPD7), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bourgogne (UB)-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon (ENSBANA)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, 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), and Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Myocardial Infarction, Infarction, Heart failure, Kaplan-Meier Estimate, Injections, Cyclophilins, Electrocardiography, Double-Blind Method, General & Internal Medicine, Internal medicine, medicine, Humans, [ SDV.IB ] Life Sciences [q-bio]/Bioengineering, cardiovascular diseases, Myocardial infarction, Mortality, Enzyme Inhibitors, Ventricular remodeling, Stroke, Aged, Ventricular Remodeling, Unstable angina, business.industry, percutaneous coronary intervention, Percutaneous coronary intervention, 11 Medical And Health Sciences, General Medicine, Middle Aged, medicine.disease, Combined Modality Therapy, 3. Good health, Injections, Intravenous, Conventional PCI, Cyclosporine, Cardiology, Female, [SDV.IB]Life Sciences [q-bio]/Bioengineering, Human medicine, Intravenous, business
Abstract

International audience; BACKGROUND: Experimental and clinical evidence suggests that cyclosporine may attenuate reperfusion injury and reduce myocardial infarct size. We aimed to test whether cyclosporine would improve clinical outcomes and prevent adverse left ventricular remodeling. METHODS: In a multicenter, double-blind, randomized trial, we assigned 970 patients with an acute anterior ST-segment elevation myocardial infarction (STEMI) who were undergoing percutaneous coronary intervention (PCI) within 12 hours after symptom onset and who had complete occlusion of the culprit coronary artery to receive a bolus injection of cyclosporine (administered intravenously at a dose of 2.5 mg per kilogram of body weight) or matching placebo before coronary recanalization. The primary outcome was a composite of death from any cause, worsening of heart failure during the initial hospitalization, rehospitalization for heart failure, or adverse left ventricular remodeling at 1 year. Adverse left ventricular remodeling was defined as an increase of 15% or more in the left ventricular end-diastolic volume. RESULTS: A total of 395 patients in the cyclosporine group and 396 in the placebo group received the assigned study drug and had data that could be evaluated for the primary outcome at 1 year. The rate of the primary outcome was 59.0% in the cyclosporine group and 58.1% in the control group (odds ratio, 1.04; 95% confidence interval [CI], 0.78 to 1.39; P=0.77). Cyclosporine did not reduce the incidence of the separate clinical components of the primary outcome or other events, including recurrent infarction, unstable angina, and stroke. No significant difference in the safety profile was observed between the two treatment groups. CONCLUSIONS: In patients with anterior STEMI who had been referred for primary PCI, intravenous cyclosporine did not result in better clinical outcomes than those with placebo and did not prevent adverse left ventricular remodeling at 1 year. (Funded by the French Ministry of Health and NeuroVive Pharmaceutical; CIRCUS ClinicalTrials.gov number, NCT01502774; EudraCT number, 2009-013713-99.)

Published
2015
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6. The efficacy of transcutaneous electrical nerve stimulation on the improvement of walking distance in patients with peripheral arterial disease with intermittent claudication: study protocol for a randomised controlled trial: the TENS-PAD study

Author

Vincent Gremeaux, Marc Labrunee, Thibaut Guiraud, Jean-Michel Senard, Damien Garrigues, Mélanie Riédel, Florent Besnier, 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 ), Réeducation Cardio-Vasculaire et Pulmonaire [Clinique de Saint-Orens], Clinique Saint-Orens, Service de Pharmacologie Clinique du CHU de Toulouse, Université Paul Sabatier - Toulouse 3 ( UPS ), Pôle Rééducation - Réadaptation (Médecine Physique et Réadaptation) (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand ( CHU Dijon ), Plateforme d’Investigation Technologique [Centre d’Investigation Clinique 1432 module Plurithématique - Dijon] ( PIT ), Cognition, Action, et Plasticité Sensorimotrice [Dijon - U1093] ( CAPS ), Université de Bourgogne ( UB ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Bourgogne ( UB ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre d'Investigation Clinique 1432 (Dijon) - Module Plurithématique : Périnatalité Cancérologie Handicap et Ophtalmologie ( CIC-P803 ), Université de Bourgogne ( UB ) -Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Service de réadaptation cardio-vasculaire (Centre Ylang Ylang de La Réunion), Centre Ylang Ylang, Service de médecine physique et réadaptation [Hôpital Rangueil - Toulouse], Hôpital de Rangueil, Ministry of Health, 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), Service de Pharmacologie Clinique, Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Plateforme d’Investigation Technologique [Centre d’Investigation Clinique 1432 module Plurithématique - Dijon] (PIT), Cognition, Action, et Plasticité Sensorimotrice [Dijon - U1093] (CAPS), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre d'Investigation Clinique 1432 (Dijon) - Module Plurithématique : Périnatalité Cancérologie Handicap et Ophtalmologie (CIC-P803), Université de Bourgogne (UB)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Direction Générale de l'Organisation des Soins (DGOS)-Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Direction Générale de l'Organisation des Soins (DGOS)

Subjects
exercise pressor reflex, Male, Time Factors, medicine.medical_treatment, Medicine (miscellaneous), Walking, 030204 cardiovascular system & hematology, law.invention, Study Protocol, association task-force, 0302 clinical medicine, Clinical Protocols, Randomized controlled trial, Quality of life, law, Pharmacology (medical), Prospective Studies, Aged, 80 and over, Transcutaneous electrical nerve stimulation, 2. Zero hunger, lcsh:R5-920, Exercise Tolerance, Rehabilitation, american-college, VO2 max, Middle Aged, Combined Modality Therapy, Exercise Therapy, 3. Good health, Treatment Outcome, Research Design, Transcutaneous Electric Nerve Stimulation, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], Female, France, medicine.symptom, lcsh:Medicine (General), management, Adult, skin, medicine.medical_specialty, Adolescent, cutaneous blood-flow, prevalence, Placebo, Peripheral Arterial Disease, Young Adult, 03 medical and health sciences, Double-Blind Method, medicine, Humans, Aged, practice guidelines, Physical activity, business.industry, Endothelial function, Recovery of Function, Intermittent Claudication, low-frequency, Intermittent claudication, [ SDV.NEU ] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], Physical therapy, business, Claudication, 030217 neurology & neurosurgery, healthy-subjects
Abstract

Background In patients with peripheral arterial disease (PAD), walking improvements are often limited by early pain onset due to vascular claudication. It would thus appear interesting to develop noninvasive therapeutic strategies, such as transcutaneous electrical nerve stimulation (TENS), to improve the participation of PAD patients in rehabilitation programmes, and thus improve their quality of life. Our team recently tested the efficacy of a single 45-min session of 10-Hz TENS prior to walking. TENS significantly delayed pain onset and increased the pain-free walking distance in patients with class-II PAD. We now seek to assess the efficacy of a chronic intervention that includes the daily use of TENS for 3 weeks (5 days a week) on walking distance in Leriche-Fontaine stage-II PAD patients. Methods/design This is a prospective, double-blind, multicentre, randomised, placebo-controlled trial. One hundred subjects with unilateral PAD (Leriche-Fontaine stage II) will be randomised into two groups (1:1). For the experimental group (TENS group): the treatment will consist of stimulation of the affected leg (at a biphasic frequency of 10 Hz, with a pulse width of 200 μs, maximal intensity below the motor threshold) for 45 min per day, in the morning before the exercise rehabilitation programme, for 3 weeks, 5 days per week. For the control group (SHAM group): the placebo stimulation will be delivered according to the same modalities as for the TENS group but with a voltage level automatically falling to zero after 10 s of stimulation. First outcome: walking distance without pain. Secondary outcomes: transcutaneous oxygen pressure (TcPO2) measured during a Strandness exercise test, peak oxygen uptake (VO2 peak), endothelial function (EndoPAT®), Ankle-brachial Pressure Index, Body Mass Index, lipid profile (LDL-C, HDL-C, triglycerides), fasting glycaemia, HbA1c level, and the WELCH questionnaire. Discussion TENS-PAD is the first randomised controlled trial that uses transcutaneous electrical therapy as an adjuvant technique to improve vascular function in the treatment of PAD. If the results are confirmed, this technique could be incorporated into the routine care in cardiovascular rehabilitation centers and used in the long term by patients to improve their walking capacity. Trial registration ClinicalTrials.gov, ID: NCT02678403. Registered on 9 February 2016. Sponsor: Toulouse University Hospital. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1997-1) contains supplementary material, which is available to authorized users.

Published
2017
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