Medical Care Versus Ventricular Assist Device for the Management of End-stage Heart Failure (MEVADE)

Inclusion criteria

All patients presenting with end-stage heart failure defined as:

• A left ventricular ejection fraction ≤25%
• Or an oxygen consumption peak < 14 mL/kg/min
• Or severe symptoms (NYHA class III or IV) despite optimal medical treatment
• Or a cardiogenic shock

Exclusion criteria

• Age over 70 years
• Active neoplasia
• Suspected or active systemic infection
• Body mass index ≥40 kg/m2
• Severe chronic obstruction pulmonary disease
• Evidence of intrinsic hepatic diseases defined as liver enzyme values ≥ 5 times the upper limit of normal within 4 days before the randomisation, or biopsy proven liver cirrhosis
• Significant chronic renal impairment with persistent creatinine >2.5 or clearance < 25ml/min
• Pregnant or lactating female
• Patient under consideration for conventional revascularization procedures, therapeutic valvular repair, left ventricular procedure or cardiomyoplasty
• Presence of implanted mechanical aortic valve that will not be converted to bioprothesis at the time of ventricular assist device implantation
• Evidence of intrinsic hepatic diseases defined as liver enzyme values ≥ 5 times the upper limit of normal, or biopsy proven liver cirrhosis
• Occurrence of stroke within 90 days or history of cerebrovascular disease with major (≥ 80%) extracranial or carotid stenosis documented by Doppler study
• Confirmation by neurologist of impairment of cognitive function, presence of Alzheimer's disease or any other form of irreversible dementia or both
• Major peripheral vascular disease accompanied by pain on rest or leg ulceration
• Recent history of psychiatric disease that is likely to impair compliance
• Drug or alcohol dependence
• Difficult social surroundings