According to current European Recommendations on valvular heart disease (VHD), "classical" severe aortic stenosis (AS) is defined by an aortic valve area (AVA) ≤1 cm2 and indexed AVA ≤0.6 cm2/m2, a mean aortic pressure gradient (MAG) \>40 mmHg, and a maximal aortic velocity \>4 m/sec. Aortic valve replacement (AVR) is recommended (class I indication) in patients with "classical" severe AS who have any symptoms related to aortic valve disease. In 2007, Hachicha et al. described a particular pattern of severe AS, characterized by an AVA ≤0.6 cm2/m2, low mean pressure aortic gradient (MAG \<40 mmHg), despite the presence of a preserved left ventricular ejection fraction (LVEF ≥50%). This pattern of AS is encountered in nearly 15-25 % of patients who have severe AS. Typically, these patients are elderly subjects, with several comorbidities, a small left ventricular (LV) cavity with pronounced LV concentric remodeling and a restrictive physiology, leading to a decrease in LV stroke volume despite a preserved LVEF. The diagnosis and management of patients with low gradient severe AS and preserved LVEF are often challenging because: 1. the presence of a "true" severe aortic stenosis should be carefully confirmed by a multi-modality imaging approach; 2. the best therapeutic management (AVR versus conservative strategy) of symptomatic patients with low gradient severe AS and preserved LVEF is not clearly established. In very recently updated European guidelines on the management of VHD, symptomatic patients with low gradient and low flow severe AS and preserved LVEF have only a class IIa-level C indication for AVR. No specific indications are given for the management of symptomatic patients with low gradient and normal flow severe AS. This lack of indications is clearly attributed to a gap in knowledge which requires further investigations to be filled up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
aortic valve replacement surgical or transcatheter aortic valve replacement (will be decided by the heart team before randomization)
strict clinical surveillance strategy
CHU Liège
Liège, Belgium
CHU Amiens - Picardie
Amiens, France
CHU Angers
Angers, France
CHU Brest - Hôpital La Cavale Blanche
Brest, France
APHP - CHU Henri Mondor
Créteil, France
CHU Dijon - Hôpital François Mitterrand
Dijon, France
CHU Lille
Lille, France
CH Bretagne Sud
Lorient, France
APHM - Hôpital La Timone
Marseille, France
Clinique du Millénaire
Montpellier, France
...and 8 more locations
time from randomization to first occurrence of any of the components of the composite outcome (adjudicated): all-cause mortality or cardiovascular related hospitalization
Time frame: during 2 years follow-up
rate of all-cause mortality
Time frame: 2 years
rate of cardiovascular mortality
Time frame: 2 years
rate of cardiovascular related hospitalization
Time frame: 2 years
rate of cerebrovascular events
Time frame: 2 years
walking distance
6-minute walking test
Time frame: 6, 12, 18 and 24 months
NT-proBNP plasma levels
Time frame: 6, 12, 18 and 24 months
quality of life score
test EQ-5D
Time frame: 6, 12, 18 and 24 months
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