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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Group managed by ventricular assist devices in first intention in Bad-Oeynhausen, Germany | ||
| Group II | Group managed with medical therapy, heart transplantation, or both, in first intention,in Paris, France |
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| Measure | Description | Time Frame |
|---|---|---|
| Survival | The primary outcome was comparison of survival at two years between the two treatment strategies | two years |
| 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. |
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Inclusion Criteria: All patients presenting with end-stage heart failure defined as:
Exclusion Criteria:
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All patients presenting with end-stage heart failure between November 2010 and October 2011 at the Heart and Diabetes Center of Bad Oeynhausen, and who underwent ventricular assist device implantations were included in group I. All patients presenting with end-stage heart failure to the Hôpital Européen Georges Pompidou or the Groupe Hospitalier Pitié-Salpêtrière, during that same period, were included in group II.
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle IDZ Durand-Zaleski, MD, PhD | UMRS 1123, Unité de Recherche Clinique en Économie de la Santé, Ile de France Hôpital Hôtel Dieu, Santé Publique Hôpital Henri Mondor, Paris, France; | Study Director |
| Nadia NA Aissaoui, MD, PhD | HEGP and Université Paris Descartes | Principal Investigator |
| Jan JG Gummert, M.D, PhD | Herz und Diabetes Zentrum, NRW | Study Chair |
| Jean-Yves JYF Fagon, MD, PhD | Study Chair |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
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| 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 |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |