The aim of the present study is to investigate safety and efficacy of early versus deferred aortic valve replacement in patients with moderate aortic stenosis combined with moderate mitral regurgitation.
In more than one-half of all patients with valvular heart disease, more than a single valve is involved. Valvular aortic stenosis coexists with significant mitral valve disease in up to one-third of patients undergoing aortic valve replacement (AVR). Guidelines for the management of valvular heart disease provide recommendations for isolated valvular lesions; data to guide timing of intervention in patients with multivalvular disease is however scarce. Currently, patients with moderate aortic stenosis (AS) in combination with mitral regurgitation have an indication for aortic valve replacement (AVR) only if the concomitant mitral regurgitation meets an indication for surgery. However, the hemodynamic stress of combined valvular lesions is greater than its individual components, and patients may benefit from early intervention. Furthermore, the presence of multivalvular heart disease complicates the assessment of individual valvular lesions. In patients with combined AS and mitral regurgitation (MR), increased left ventricular pressure exacerbates the mitral regurgitant volume. Conversely, decreased forward flow across the aortic valve underestimates the severity of aortic stenosis when assessed by a pressure gradient. Standard cut-off values inadequately reflect the hemodynamic stress in concomitant aortic and mitral valve disease, and recommendations for the timing of valvular replacement fail to account for the complex interplay of multiple valvular lesions. Timing of intervention in patients with combined AS and MR is therefore challenging and evidence on the optimal timing of intervention is scarce. Thus, the objective of the present study is to investigate safety and efficacy of early versus deferred aortic valve replacement in patients with moderate aortic stenosis combined with at least moderate mitral regurgitation. Patients with combined aortic stenosis and mitral regurgitation will be screened for eligibility. If eligible and informed consent is provided, patients will be randomly allocated in a 1:1 ratio to early (within 3 months) or deferred aortic valve replacement (with or without mitral valve intervention).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Early transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement.
Deferred transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement.
Insel Gruppe AG, Inselspital Bern
Bern, Switzerland
RECRUITINGUniversity Hospital Geneva (HUG)
Geneva, Switzerland
RECRUITINGHeart Clinic Hirslanden
Zurich, Switzerland
RECRUITINGThe primary outcome will be a composite of all-cause death, stroke, and unplanned hospitalization for heart failure related to valvular heart disease at 2 years.
Time frame: 2 years
All-cause death
Number of all-cause death within study participation
Time frame: 5 years
Cardiovascular death
Number of patients with Cardiovascular death within study participation
Time frame: 5 years
Neurologic events
Number of patients with stroke, symptomatic hypoxic-ischaemic injury, TIA and evaluation
Time frame: 5 years
Hospitalization for heart failure
Number of patients who need hospitalization for heart failure within study participation and evaluation
Time frame: 5 years
New-onset atrial fibrillation
Number of patients with new-onset atrial fibrillation within study participation and evaluation
Time frame: 5 years
Implantation of a permanent pacemaker
Number of patients with atrioventricular conductance disturbance requiring the implantation of a permanent pacemaker
Time frame: 5 years
Aortic or mitral valve re-intervention
Number of patients with Aortic or mitral valve re-intervention within study participation and evaluation
Time frame: 5 years
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NYHA functional class
Measurement of NYHA functional class within study participation
Time frame: 5 years
Days alive out of hospital (DAOH)
Calculation of days alive out of hospital (DAOH) within study participation
Time frame: 5 years
The evaluation Health-related quality of life assessment by means of the KCCQ 12 questionnaire
Record the health-related quality of life assessment by means of the KCCQ 12 questionnaire within study participation
Time frame: 5 years