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      Outcomes of Patients With Asymptomatic Aortic Stenosis Followed Up in Heart Valve Clinics

      1 , 2 , 3 , 1 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 1 , 14 , 15 , 16 , 16 , 16 , 1 , 1 , 1 , 6 , 17 , 18 , 5 , 1 , 4 , 4 , 8 , 19 , 19 , 20 , 21 , 22 , 23 , 1 , 19 , 4 , 1
      JAMA Cardiology
      American Medical Association (AMA)

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          A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease.

          To identify the characteristics, treatment, and outcomes of contemporary patients with valvular heart disease (VHD) in Europe, and to examine adherence to guidelines. The Euro Heart Survey on VHD was conducted from April to July 2001 in 92 centres from 25 countries; it included prospectively 5001 adults with moderate to severe native VHD, infective endocarditis, or previous valve intervention. VHD was native in 71.9% of patients and 28.1% had had a previous intervention. Mean age was 64+/-14 years. Degenerative aetiologies were the most frequent in aortic VHD and mitral regurgitation while most cases of mitral stenosis were of rheumatic origin. Coronary angiography was used in 85.2% of patients before intervention. Of the 1269 patients who underwent intervention, prosthetic replacement was performed in 99.0% of aortic VHD, percutaneous dilatation in 33.9% of mitral stenosis, and valve repair in 46.5% of mitral regurgitation; 31.7% of patients had > or =1 associated procedure. Of patients with severe, symptomatic, single VHD, 31.8% did not undergo intervention, most frequently because of comorbidities. In asymptomatic patients, accordance with guidelines ranged between 66.0 and 78.5%. Operative mortality was <5% for single VHD. This survey provides unique contemporary data on characteristics and management of patients with VHD. Adherence to guidelines is globally satisfying as regards investigations and interventions.
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            Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.

            The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. Two in-person meetings (held in September 2011 in Washington, DC, USA, and in February 2012 in Rotterdam, the Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and non-interventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiography recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints. This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVI and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavors of applying definitions to other transcatheter valve therapies (for example, mitral valve repair). Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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              Two-year outcomes after transcatheter or surgical aortic-valve replacement.

              The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits. At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation. The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001). A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).
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                Author and article information

                Journal
                JAMA Cardiology
                JAMA Cardiol
                American Medical Association (AMA)
                2380-6583
                November 01 2018
                November 01 2018
                : 3
                : 11
                : 1060
                Affiliations
                [1 ]GIGA Cardiovascular Sciences, Department of Cardiology, Heart Valve Clinic, University of Liège Hospital, Centre Hospitalier Universitaire du Sart Tilman, Liège, Belgium
                [2 ]Gruppo Villa Maria Care and Research, Anthea Hospital, Bari, Italy
                [3 ]Cardiology Department, Centre Hospitalier Universitaire de Limoges, Hôpital Dupuytren, Pôle Coeur-Poumon-Rein, Limoges, France
                [4 ]Québec Heart and Lung Institute, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Laval University, Quebec City, Québec, Canada
                [5 ]Cardiologie and LTSI INSERM U 1099, Centre Hospitalier Universitaire de Rennes, Université de Rennes 1, Rennes, France
                [6 ]Marcus Heart Valve Center, Piedmont Heart Institute, Atlanta, Georgia
                [7 ]Guy’s and St Thomas Hospitals, London, United Kingdom
                [8 ]Department of Cardiology, Medical University of Vienna, Vienna, Austria
                [9 ]Aix-Marseille Université, Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes, Marseille, France
                [10 ]Assistance Publique–Hopitaux Marseille, La Timone Hospital, Cardiology Department, Marseille, France
                [11 ]Barts Heart Centre Echo Lab, St Bartholomew’s Hospital, London, United Kingdom
                [12 ]Cardiology Service, CMSR Veneto Medica, Altavilla Vicentina, Italy
                [13 ]King’s Health Partners, King’s College Hospital NHS Foundation Trust, London, United Kingdom
                [14 ]Department of Cardiovascular Surgery, GVM Care and Research, Maria Eleonora Hospital, Palermo, Italy
                [15 ]Department of Surgery and Cancer, University of Palermo, Palermo, Italy
                [16 ]Centre Hospitalier Universitaire de Lille, Departments of Clinical Physiology and Echocardiography and Cardiovascular Surgery, Lille, France
                [17 ]Morristown Medical Center, Morristown, New Jersey
                [18 ]Section of Cardiology, Department of Medicine, University of Verona, Verona, Italy
                [19 ]Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands
                [20 ]Centrum voor Hart en Vaatziekten, Universitair Ziekenhuis Brussel and In Vivo Cellular and Molecular Imaging Laboratory, Brussels, Belgium
                [21 ]Centre Hospitalier Universitaire de Bordeaux, Hôpital Cardiologique Haut-Lévêque, Pessac, France
                [22 ]Cardiology Department, University of Tours Hospital, Tours, France
                [23 ]University François Rabelais, Tours, France
                Article
                10.1001/jamacardio.2018.3152
                30285058
                db54bec9-adb2-4cd2-901c-b8b25f032c53
                © 2018
                History

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