Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock

Eligibility Criteria

• * Acute myocardial infarction (AMI) of \<36 hours duration from symptom onset to cath lab arrival, confirmed by:
• * ECG and/or biomarker evidence of ST-segment elevation myocardial infarction (STEMI) or
• * ECG and/or biomarker evidence of non-ST-segment elevation myocardial infarction (NSTEMI) and angiographic evidence of one or more culprit vessels
• * Cardiogenic shock that develops under one of the following conditions: prior to primary PCI, with \<24 hours from the onset of shock to cath lab arrival, or within 12 hours after initiating primary PCI. Cardiogenic shock is confirmed by at least two of the following:
• * Peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5 mmol/l or SvO2 \<55% with a normal PaO2)
• * Systolic blood pressure \<100 mmHg or need for vasoactive agents to maintain systolic blood pressure ≥100 mmHg
• * Hemodynamic criteria represented by a cardiac index of \<2.2 L/min/m2 or a cardiac power output ≤0.6 W
• * Patient received PCI to treat the AMI
• * Patient was supported with Impella CP as the initial MCS device for cardiogenic shock
• * Age ≥18 years
• * Any contraindication listed in the Impella CP IFU if known to be present (i.e. mural thrombus in the left ventricle; presence of a mechanical aortic valve or heart constrictive device; aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); severe arterial disease precluding placement of the Impella system; presence of an atrial or ventricular septal defect (including post-infarct VSD); significant right heart failure; left ventricular rupture; cardiac tamponade; combined cardiorespiratory failure).
• * 2\. Shock principally due to a cause other than LV failure, including:
• * RV infarction, hypovolemia, anaphylaxis, hemorrhage, sepsis, myocarditis, pulmonary embolism, pneumothorax, or high cardiac output shock
• * Severe arrhythmias as the primary cause of low cardiac output
• * Known mechanical complications of AMI that may cause cardiogenic shock such as free wall rupture, ventricular septal defect or papillary muscle rupture with acute mitral regurgitation
• * Other mechanical circulatory support already in place for present indication, including intra-aortic balloon counter-pulsation or patients with Impella CP placement prior to transfer to the cath lab at the tertiary facility
• * Acute or chronic aortic dissection
• * Prior PCI at another institution for the present infarction
• * Thrombolytic therapy for the present infarction
• * Not obeying verbal commands after preadmission or in-hospital cardiac arrest, indicative of possible anoxic brain injury NOTE:
• * Non-intubated subjects: A positive and appropriate response to commands must be repeatable on at least two (2) instances to rule out reflex response to voice
• * Intubated subjects: May be included if:
• * They were following verbal commands immediately prior to intubation, or
• * They were clearly following verbal commands after intubation
• * Infective endocarditis
• * Other severe, concomitant disease with limited life expectancy \<1 year (other than cardiogenic shock)
• * Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached the timing of its primary endpoint