Myocardial Infarction Clinical Trial
Official title:
Left Ventricular Assist Device (Impella LP 2.5) vs. Intraaortic Balloon Counterpulsation (IABP) in Patients With Cardiogenic Shock and Acute Coronary Syndromes
The purpose of this study is to evaluate the efficacy and safety of a left ventricular assist device in comparison to a standard treatment with an intraaortic balloon pump (IABP) in patients with cardiogenic shock due to left ventricular failure following an acute coronary syndrome (myocardial infarction).
Cardiogenic shock due to a left ventricular failure after myocardial infarction (MI) is
associated with a mortality rate of 50-70 % despite all efforts such as immediate PCI of the
occluded vessel, positive inotropic drugs, and the use of intraaortic balloon
counterpulsation (IABP). While urgent heart transplantation or the surgical implantation of
high-volume left ventricular assist devices are possible treatment options, a widespread use
of these techniques for this common complication of myocardial infarction is limited.
Because of the easy, percutaneous use of an intraaortic balloon pump, IABP is the method of
choice for mechanical assistance in these patients. Despite a lack of randomized data, the
ACC/AHA guidelines recommend the use of an intraaortic balloon counterpulsation (Level of
evidence IB) in patients with a cardiogenic shock after myocardial infarction. However,
improvement of the hemodynamic state by the use of an IABP is limited and the lack of an
active cardiac support remains the major limitation of this treatment. Percutaneous left
ventricular assist devices may both overcome the limitation of a surgical approach and offer
the potential benefit of an active cardiac support during recovery of the failing left
ventricle after PCI.
Previous studies have demonstrated a significant improvement of hemodynamic parameters by
the use of a catheter-based miniaturized rotary blood pump (Impella LP2.5, Abiomed-Impella
CardioSystems GmbH, Aachen, Germany), that is placed retrogradely through the aortic valve.
The microaxial pump aspirates blood from the left ventricle and expels it to the ascending
aorta with a maximal flow of 2.5 L/min. Randomized data comparing the LVAD with IABP are
missing. Therefore, this trial will primarily compare the hemodynamic improvement of the
LVAD (Impella LP2.5) with the hemodynamic improvement of an intraaortic balloon
counterpulsation (IABP), while secondarily feasibility, safety and mortality will be
compared.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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