Aortic stenosis is the most common valvular disease in the Western world. It is caused by progressive narrowing of the aortic valve leading to increased strain on the heart muscle which has to work increasingly hard to pump blood through the narrowed valve. Over time the heart muscle thickens to generate more force, but eventually the heart fails leading to death if the valve is not replaced with an operation. No medical treatments exist to stop or reverse the heart valve narrowing. Current clinical guidelines suggest that an operation should be performed only when symptoms develop or the heart muscle is visibly weak on cardiac ultrasound scanning. However, symptoms can be difficult to interpret and in many patients the heart muscle has become irreversibly damaged and the heart fails to recover following surgery. Using MRI scans of the heart, the investigators have identified heart scarring which seems to develop as the heart muscle thickens. Several studies now show that people who have developed this scarring are more likely to suffer poor outcomes including death. The investigators have also identified clinical risks that predict the presence of scarring. The investigators propose a study where patients with severe aortic stenosis but no indications for valve replacement as per current guidelines are assessed for those clinical risks. If a participant's risk of having scarring is higher they will undergo a cardiac MRI scan. If scarring is present participants will be randomised to routine clinical care, or referral for valve replacement surgery. Participants with no evidence of scarring will be randomised routine care with study follow or not. The investigators of this study hypothesize that early surgery will lead to fewer complications and reduced risk of death compared to standard care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,000
The choice of either surgical aortic valve replacement or transcatheter aortic valve implantation (TAVI) will be made by the local clinical team according to local policies. In patients undergoing surgical replacement the choice of surgical technique and type of valve replacement used will be at the discretion of the operating surgeon. Patients found to have significant coronary artery disease requiring concomitant coronary artery bypass surgery will not be excluded. Similarly the choice of TAVI valve and need for percutaneous coronary intervention will be made by the TAVI heart team. The procedure should be performed as soon as possible and ideally within four months of randomisation and allocation to group A.
NHS Lothian
Edinburgh, United Kingdom
Composite of all-cause mortality or unplanned aortic stenosis-related hospitalisation
The first event of all-cause mortality or unplanned aortic stenosis-related hospitalisation Unplanned aortic stenosis-related hospitalisation is defined as an unplanned admission with syncope, heart failure, chest pain or arrhythmia (ventricular arrhythmia or second or third degree heart block) attributed to aortic stenosis. This endpoint will be adjudicated by two independent investigators blinded to the details of randomisation following review of the case notes and hospital records.
Time frame: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
All-cause mortality
Time frame: Randomisation through to study completion, an average of 2.75 years
Cardiovascular death
Time frame: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
AS-related death
AS-related death is a death where aortic stenosis has been listed as a contributory cause by the clinical care team on the patient's official death certificate.
Time frame: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
Sudden cardiac death
Time frame: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
Unplanned aortic-stenosis related hospitalisation
Unplanned aortic stenosis-related hospitalisation is defined as an unplanned admission with syncope, heart failure, chest pain or arrhythmia (ventricular arrhythmia or second or third degree heart block) attributed to aortic stenosis.
Time frame: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
WHODAS 2.0 (12 item)
The World Health Organization Disability Assessment Schedule (WHODAS 2.0) is a generic assessment instrument developed by WHO to provide a standardized method for measuring health and disability across cultures.
Time frame: At study completion (mean follow up is expected to be an average of 2.75 years)
LV systolic function
The development of LV systolic dysfunction (EF \<50% quantitatively or at least mild LV dysfunction qualitatively)
Time frame: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
NYHA status
Self reported patient symptoms on a scale of I-IV (I = No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, IV = Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.)
Time frame: At study completion (mean follow up is expected to be an average of 2.75 years)
Permanent pacemaker insertion, cardiac resynchronisation therapy or automated implantable cardioverter defibrillator
To compare between study arms the number of participants who have had a permanent pacemaker insertion, cardiac resynchronisation therapy or automated implantable cardioverter defibrillator
Time frame: Randomisation to through to study completion (mean follow up is expected to be an average of 2.75 years)
Stroke
Time frame: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
Endocarditis
To compare between study arms the number of participants who have endocarditis
Time frame: Randomisation to through to study completion (mean follow up is expected to be an average of 2.75 years)
Post-operative complications following aortic valve intervention
Time frame: 30 days post aortic valve intervention
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