Rationale and design of SAVI-AoS: A physiologic study of patients with symptomatic moderate aortic valve stenosis and preserved left ventricular ejection fraction.
Int J Cardiol Heart Vasc
; 41: 101063, 2022 Aug.
Article
em En
| MEDLINE
| ID: mdl-35663622
ABSTRACT
Background:
Moderate aortic valve stenosis occurs twice as often as severe aortic stenosis (AS) and carries a similarly poor prognosis. Current European and American guidelines offer limited insight into moderate AS (MAS) patients with unexplained symptoms. Measuring valve physiology at rest while most patients experience symptoms during exertion might represent a conceptual limitation in the current grading of AS severity. The stress aortic valve index (SAVI) may delineate hemodynamically significant AS among patients with MAS.Objectives:
To investigate the diagnostic value of SAVI in symptomatic MAS patients with normal left ventricular ejection fraction (LVEF ≥ 50%) aortic valve area (AVA) > 1 cm2 plus either mean valve gradient (MG) 15-39 mmHg or maximal aortic valve velocity (AOV max) 2.5-3.9 m/s. Short-term objectives include associations with symptom burden, functional capacity, and cardiac biomarkers. Long-term objectives include clinical outcomes. Methods andresults:
Multicenter, non-blinded, observational cohort. AS severity will be graded invasively (aortic valve pressure measurements with dobutamine stress testing for SAVI) and non-invasively (echocardiography during dobutamine and exercise stress). Computed tomography (CT) of the aortic valve will be scored for calcium, and hemodynamics simulated using computational fluid dynamics. Cardiac biomarkers and functional parameters will be serially monitored. The primary objective is to see how SAVI and conventional measures (MG, AVA and Vmax) correlate with clinical parameters (quality of life survey, 6-minute walk test [6MWT], and biomarkers).Conclusions:
The SAVI-AoS study will extensively evaluate patients with unexplained, symptomatic MAS to determine any added value of SAVI versus traditional, resting valve parameters.
6MWT, 6-minute walking test; AOV max, Maximal aortic valve velocity; AS, Aortic stenosis; AVA, Aortic valve area; CCS, Canadian Cardiovascular Society; IQR, Interquartile range; KCCQ-OS, Kansas City Cardiomyopathy Questionnaire Overall Score; LV, Left ventricle/ventricular; LVEF, Left ventricular ejection fraction; LVOT, Left ventricular outflow tract; MAS:, Moderate aortic stenosis; MDCT, Multi-detector computed tomography; MG, Mean valve gradient; Moderate aortic stenosis; NT-proBNP, N-terminal pro-B-type natriuretic peptide; NYHA, New York Heart Association; SAVI; SAVI, Stress aortic valve index; SAVR, Surgical aortic valve replacement; TAVI, Transcatheter aortic valve implantation/replacement
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Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
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Diagnostic_studies
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Guideline
/
Prognostic_studies
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Qualitative_research
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article