Rationale and Design of Savi-AoS: A Physiologic Study of Patients With Symptomatic Moderate Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction

Authors

Rob Eerdekens
Pim Tonino
Jo Zelis
Rik Adrichem
Jung-Min Ahn
Jesse Demandt
Ashkan Eftekhari
Mohamed El Farissi
Phillip Freeman
Abdul Rahman Ihdayhid
Nikolaos Kakouros
Dae-Hee Kim
Seung-Ah Lee
Nicolas M Van Mieghem
Waqas Qureshi
Nils P Johnson

Publication Date

8-1-2022

Journal

International Journal of Cardiology Congenital Heart Disease

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 and results: 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.

Keywords

SAVI, Moderate aortic stenosis

DOI

10.1016/j.ijcha.2022.101063

PMID

35663622

PMCID

PMC9157233

PubMedCentral® Posted Date

5-27-2022

PubMedCentral® Full Text Version

Post-print

Published Open-Access

yes