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Transcatheter aortic valve implantation using the SAPIEN 3 valve to treat aortic regurgitation: The French multicentre S3AR study
Institution:1. Department of Cardiology, Bichat Hospital, AP–HP, Inserm U 1148, University of Paris, 75018 Paris, France;2. Medipôle Lyon–Villeurbanne, 69100 Villeurbanne, France;3. Rangueil Hospital, 31400 Toulouse, France;4. Strasbourg University Hospital, 67000 Strasbourg, France;5. Hôpital Cardiologique et Pneumologique Louis-Pradel, Hospices Civils de Lyon, 69500 Bron, France;6. Department of Interventional Cardiology for Coronary, Valves and Structural Heart Diseases, Institut C?ur Poumon, Cardiology, CHU Lille, 59000 Lille, France;7. Service Médico-Chirurgical de Valvulopathies, University Hospital Angers, 49100 Angers, France;8. Besançon University Hospital, 25000 Besançon, France;1. Cardiology Department, Institut cardiovasculaire de Strasbourg, 67000 Strasbourg, France;2. Cardiology Department, centre cardiologique du Nord, 32–36, rue des Moulins Gémeaux, 93200 Saint-Denis, France;3. Cardiology Department, clinique Pasteur, 31000 Toulouse, France;4. Cardiology Department, University Hospital of Tours and University François-Rabelais, 37044 Tours, France;5. Cardiology Department, University Hospital of Grenoble-Alpes and Grenoble-Alpes University, CS 10217, 38043 Grenoble, France;1. Department of Cardiac and Thoracic Surgery, Cardiology Institute, Pitié-Salpêtrière Hospital, AP-HP, Sorbonne University Medical School, 75013 Paris, France;2. Department of Anaesthesiology and Critical Care Medicine, Cardiology Institute, Pitié-Salpêtrière Hospital, AP-HP, Sorbonne University Medical School, 75013 Paris, France;3. Inserm, UMRS 1166-ICAN, Institute of Cardiometabolism and Nutrition, 75013 Paris, France;4. Department of Medical Intensive Care Unit, Cardiology Institute, Pitié-Salpêtrière Hospital, AP-HP, Sorbonne University Medical School, 75013 Paris, France;5. Paris Translational Research Centre for Organ Transplantation, Inserm, UMR-S970, 75015 Paris, France;1. Département de cardiologie, CHU Timone, 13005 Marseille, France;2. C2VN, Aix-Marseille université, Inserm, INRA, 13005 Marseille, France;3. Faculté de médecine, Aix-Marseille université, 13385 Marseille, France;4. Service de cardiologie, centre hospitalier universitaire trousseau et Faculté de médecine, université de Tours, 37032 Tours, France;5. EA4245 Transplantation immunité inflammation, université de Tours, 37032 Tours, France;6. Département de cardiologie, CHU Nord, 13015 Marseille, France;7. Service d’information médicale, d’épidémiologie et d’économie de la santé, centre hospitalier universitaire et Faculté de médecine, EA7505, université de Tours, 37044 Tours, France;1. Department of General Practice, Amsterdam University Medical Centre, Vrije Universiteit Amsterdam, 1081 BT Amsterdam, The Netherlands;2. Health Behaviours & Chronic Diseases, Amsterdam Public Health Research Institute, 1081 BT Amsterdam, The Netherlands;3. Department of Epidemiology and Data Science, Amsterdam University Medical Centre, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, 1081 HV Amsterdam, The Netherlands;4. National Healthcare Group Polyclinics, Singapore, 138543;1. EA CHIMERE 7516, department of vascular medicine, Picardie Jules Verne university, CHU Amiens Picardie, 80054 Amiens, France;2. EA HEMATIM 4666, department of genetics, Picardie Jules Verne university, CHU Amiens Picardie, 80054 Amiens, France;3. Thrombosis and atherosclerosis research unit, vessels and blood institute (IVS), anticoagulation clinic (CREATIF), Lariboisière hospital, AP–HP, 75010 Paris, France;4. Department of cardiology, CHU Grenoble, 38700 La Tronche, France;5. Department of cardiology, hospital of Antibes, 06600 Antibes, France;6. Department of gynaecology, Cochin hospital, AP–HP, 75014 Paris, France;7. French Society of cardiology, 75012 Paris, France;8. EA 3878, CIC Inserm 1412, FCRIN INNOVTE, department of internal medicine and pneumology, university of Western Brittany, CHU Brest, 29609 Brest, France;9. Institute of cardiology, La Pitié-Salpêtrière hospital, Sorbonne university, AP–HP, 47-83, boulevard de l’Hôpital, 75651 Paris cedex 13, France;1. Florida Atlantic University and Delray Medical Center, Boca Raton, Florida, USA;2. Université Laval/Québec Heart and Lung Institute, Quebec, Canada;3. New York Presbyterian Hospital, Columbia University Medical Center, New York, New York, USA;4. Massachusetts General Hospital, Boston, Massachusetts, USA;5. Bern University Hospital, Bern, Switzerland;6. University of Texas Southwestern Medical Center, Dallas, Texas, USA;7. The Heart Hospital Baylor Plano, Plano, Texas, USA;8. Pima Heart and Vascular/Tucson Medical Center, Tucson, Arizona, USA;9. Beaumont Health and Spectrum Health, Royal Oak, Michigan, USA;10. Oakland University William Beaumont School of Medicine, Auburn Hills, Michigan, USA
Abstract:BackgroundTranscatheter aortic valve implantation now has a major role in the treatment of patients with severe aortic stenosis. However, evidence is scarce on its feasibility and safety to treat patients with pure aortic regurgitation.AimsWe sought to evaluate the results of transcatheter aortic valve implantation using the balloon-expandable SAPIEN 3 transcatheter heart valve (Edwards Lifesciences, Irvine, CA, USA) in patients with pure aortic regurgitation on native non-calcified valves.MethodsWe conducted a retrospective and prospective French multicentre observational study. We included all patients with symptomatic severe pure aortic regurgitation on native non-calcified valves, contraindicated to or at high risk for surgical valve replacement, who underwent transcatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve.ResultsA total of 37 patients (male sex, 73%) with a median age of 81 years (interquartile range 69–85 years) were screened using transthoracic echocardiography and computed tomography and were included at eight French centres. At baseline, 83.8% of patients (n = 31) had dyspnoea New York Heart Association class  III. The device success rate was 94.6% (n = 35). At 30 days, the all-cause mortality rate was 8.1% (n = 3) and valve migration occurred in 10.8% of cases (n = 4). Dyspnoea New York Heart Association class  II was seen in 86.5% of patients (n = 32), and all survivors had aortic regurgitation grade  1. At 1-year follow-up, all-cause mortality was 16.2% (n = 6), 89.7% (n = 26/29) of survivors were in New York Heart Association class  II and all had aortic regurgitation grade  2.ConclusionTranscatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve seems promising to treat selected high-risk patients with pure aortic regurgitation on non-calcified native valves, contraindicated to surgical aortic valve replacement.
Keywords:Aortic regurgitation  Transcatheter aortic valve implantation  Balloon-expandable transcatheter heart valve  Non-calcified aortic valve  AR"}  {"#name":"keyword"  "$":{"id":"kw0030"}  "$$":[{"#name":"text"  "_":"aortic regurgitation  AS"}  {"#name":"keyword"  "$":{"id":"kw0040"}  "$$":[{"#name":"text"  "_":"aortic stenosis  CE"}  {"#name":"keyword"  "$":{"id":"kw0050"}  "$$":[{"#name":"text"  "_":"Conformité Européenne  CT"}  {"#name":"keyword"  "$":{"id":"kw0060"}  "$$":[{"#name":"text"  "_":"computed tomography  LVEF"}  {"#name":"keyword"  "$":{"id":"kw0070"}  "$$":[{"#name":"text"  "_":"left ventricular ejection fraction  NYHA"}  {"#name":"keyword"  "$":{"id":"kw0080"}  "$$":[{"#name":"text"  "_":"New York Heart Association  SPAP"}  {"#name":"keyword"  "$":{"id":"kw0090"}  "$$":[{"#name":"text"  "_":"systolic pulmonary artery pressure  TAVI"}  {"#name":"keyword"  "$":{"id":"kw0100"}  "$$":[{"#name":"text"  "_":"transcatheter aortic valve implantation  THV"}  {"#name":"keyword"  "$":{"id":"kw0110"}  "$$":[{"#name":"text"  "_":"transcatheter heart valve  TTE"}  {"#name":"keyword"  "$":{"id":"kw0120"}  "$$":[{"#name":"text"  "_":"transthoracic echocardiography  VARC"}  {"#name":"keyword"  "$":{"id":"kw0130"}  "$$":[{"#name":"text"  "_":"Valve Academic Research Consortium
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