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

Study Overview
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Brief Summary
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End-stage heart failure (ESHF) represents a major burden in terms of quality of life, mortality and costs. The current practice in France is to treat patients with ESHF by a combination of drugs and lifestyle interventions before proposing heart transplant (HT) if there is no contraindication. In the Heart and Diabetes Center of Bad Oyenhausen (BO) in Germany, patients presenting with ESHF are preferentially managed by ventricular assist device (VAD) therapy. The primary purpose of this study was to compare the outcomes of these two strategies in the management of ESHF and associated consumption of resources.

Official Title
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Medical Care Versus Ventricular Assist Device in Patients With NYHA Class IV Congestive Heart Failure: a Non Randomized Comparison of Clinical and Economic Outcomes

Conditions
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Heart Failure, Heart Transplantation, Heart-Assist Devices

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>Group managed by ventricular assist devices in first intention in Bad-Oeynhausen, Germany | |
| Group II<br>Group managed with medical therapy, heart transplantation, or both, in first intention,in Paris, France | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | The primary outcome was comparison of survival at two years between the two treatment strategies | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resource consumption | One secondary outcomes was comparison of the treatment strategies up to two years of follow-up about resource consumption. | Two years | 
| Costs | One secondary outcomes was comparison of the treatment strategies up to two years of follow-up about costs. | Two years | 
| Costs versus survival | One secondary outcomes was comparison of the treatment strategies up to two years of follow-up about costs versus survival. | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End Stage Heart Failure, New York Heart Association functional class III or IV, Heart transplantation, Ventricular assisted devices, Cardiogenic shock