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

Andrea Barbieri; Francesco Antonini-Canterin; Mauro Pepi; Ines Paola Monte; Giuseppe Trocino; Agata Barchitta; Quirino Ciampi; Alberto Cresti; Sofia Miceli; Licia Petrella; Frank Benedetto; Concetta Zito; Giovanni Benfari; Francesca Bursi; Alessandro Malagoli; Ylenia Bartolacelli; Francesca Mantovani; Marie-Annick Clavel

doi:10.4103/jcecho.jcecho_68_20

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

J Cardiovasc Echogr. 2020 Apr-Jun;30(2):52-61. doi: 10.4103/jcecho.jcecho_68_20. Epub 2020 Aug 17.

Authors

Andrea Barbieri¹, Francesco Antonini-Canterin², Mauro Pepi³, Ines Paola Monte⁴, Giuseppe Trocino⁵, Agata Barchitta⁶, Quirino Ciampi⁷, Alberto Cresti⁸, Sofia Miceli⁹, Licia Petrella¹⁰, Frank Benedetto¹¹, Concetta Zito¹², Giovanni Benfari¹³, Francesca Bursi¹⁴, Alessandro Malagoli¹⁵, Ylenia Bartolacelli¹⁶, Francesca Mantovani¹⁷, Marie-Annick Clavel¹⁸

Affiliations

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.

Abstract

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.

Keywords: Aortic valve calcium score; aortic valve stenosis; diagnosis; dobutamine stress echocardiography; echocardiography.