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Year : 2020  |  Volume : 30  |  Issue : 2  |  Page : 52-61

Discordant echocardiographic grading in low gradient aortic stenosis (DEGAS study) from the Italian society of echocardiography and cardiovascular imaging research network: Rationale and study design

1 Division of Cardiology, Department of Diagnostics, Clinical and Public Health Medicine, Policlinico University Hospital of Modena, Milano, Italy
2 Rehabilitative Cardiology, Ospedale Riabilitativo di Alta Specializzazione di Motta di Livenza (TV), Milano, Italy
3 Monzino Cardiology Center, IRCCS, Milano, Italy
4 Cardiology, AOU Policlinic, University of Catania, Italy
5 Cardiology, Hospital of Desio, S. Antonio Hospital, AO Padova, Italy
6 Emergency Medicine, S. Antonio Hospital, AO Padova, Italy
7 Cardiology, Fatebenefratelli Hospital, Benevento, Italy
8 Cardiology, Dip. Cardio Neuro Vascolare Asl sudest Toscana, Hospital of Grosseto, Italy
9 Geriatrics, AOU Mater-Domini, Catanzaro, Italy
10 Cardiology, “Mazzini” Hospital, Teramo, Italy
11 Cardiology, G.O.M. “Bianchi Melacrino Morelli”, Reggio Calabria, Italy
12 Department of Clinical and Experimental Medicine - Section of Cardiology, G. Martino General Hospital, University of Messina, Italy
13 Section of Cardiology, Department of Medicine, University of Verona, Italy
14 Division of Cardiology, Heart and Lung Department, San Paolo Hospital, ASST Santi Paolo and Carlo, University of Milan, Italy
15 AOU Modena Baggiovara, Italy
16 Pediatric and Adult Congenital Heart Cardiac Surgery, S.Orsola Malpighi Hospital, University of Bologna, Italy
17 Azienda USL- IRCCS di Reggio Emilia, Italy
18 Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval, Quebec City, Quebec, Canada

Correspondence Address:
Andrea Barbieri
Department of Diagnostics, Division of Cardiology, Clinical and Public Health Medicine, Policlinico University Hospital of Modena, Modena
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jcecho.jcecho_68_20

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Background: Low-gradient aortic stenosis (LG-AS) is characterized by the combination of an aortic valve area compatible with severe stenosis and a low transvalvular mean gradient with low-flow state (i.e., indexed stroke volume <35 mL/m2) in the presence of reduced (classical low-flow AS) or preserved (paradoxical low-flow AS) ejection fraction. Furthermore, the occurrence of a normal-flow LG-AS is still advocated by many authors. Within this diagnostic complexity, the diagnosis of severe AS remains challenging. Objective: The general objective of the Discordant Echocardiographic Grading in Low-gradient AS (DEGAS Study) study will be to assess the prevalence of true severe AS in this population and validate new parameters to improve the assessment and the clinical decision-making in patients with LG-AS. Methods and Analyses: The DEGAS Study of the Italian Society of Echocardiography and Cardiovascular Imaging is a prospective, multicenter, observational diagnostic study that will enroll consecutively adult patients with LG-AS over 2 years. AS severity will be ideally confirmed by a multimodality approach, but only the quantification of calcium score by multidetector computed tomography will be mandatory. The primary clinical outcome variable will be 12-month all-cause mortality. The secondary outcome variables will be (i) 30-day mortality (for patients treated by Surgical aortic valve replacement or TAVR); (ii) 12-month cardiovascular mortality; (iii) 12-month new major cardiovascular events such as myocardial infarction, stroke, vascular complications, and rehospitalization for heart failure; and (iv) composite endpoint of cardiovascular mortality and hospitalization for heart failure. Data collection will take place through a web platform (REDCap), absolutely secure based on current standards concerning the ethical requirements and data integrity.

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