TY - JOUR
T1 - Discordant echocardiographic grading in low gradient aortic stenosis (DEGAS study) from the Italian society of echocardiography and cardiovascular imaging research network
T2 - Rationale and study design
AU - Barbieri, Andrea
AU - Antonini-Canterin, Francesco
AU - Pepi, Mauro
AU - Monte, Ines
AU - Trocino, Giuseppe
AU - Barchitta, Agata
AU - Ciampi, Quirino
AU - Cresti, Alberto
AU - Miceli, Sofia
AU - Petrella, Licia
AU - Benedetto, Frank
AU - Zito, Concetta
AU - Benfari, Giovanni
AU - Bursi, Francesca
AU - Malagoli, Alessandro
AU - Bartolacelli, Ylenia
AU - Mantovani, Francesca
AU - Clavel, Marie Annick
N1 - Publisher Copyright:
© 2020 Wolters Kluwer Medknow Publications. All rights reserved.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/4/1
Y1 - 2020/4/1
N2 - 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/m) 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.
AB - 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/m) 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.
KW - Aortic valve calcium score
KW - aortic valve stenosis
KW - diagnosis
KW - dobutamine stress echocardiography
KW - echocardiography
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U2 - 10.4103/jcecho.jcecho_68_20
DO - 10.4103/jcecho.jcecho_68_20
M3 - Article
AN - SCOPUS:85090883347
VL - 30
SP - 52
EP - 61
JO - Journal of Cardiovascular Echography
JF - Journal of Cardiovascular Echography
SN - 2211-4122
IS - 2
ER -