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

Inclusion 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), STEMI equivalents, or new or presumed new left bundle branch block 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 confirmed by at least two of the following:

• Tissue hypoperfusion, manifested by an arterial or venous blood lactate level ≥2.5 mmol/L or SvO2 <55% in the presence of a PaO2 > 90mmHg
• 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/m^2 or a cardiac power output ≤0.6 W
• 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
• <12 hours after initiating primary PCI
• Patient was supported with Impella CP as the initial MCS device for cardiogenic shock
• Age ≥18 years
• Europe only: Subject or legally designated representative (LDR) or Independent Physician has provided written informed consent for participation in the observational study

Exclusion criteria

• 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).
• 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, including acute bradyarrhythmias, tachyarrhythmias, or advanced heart block
• 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
• Procedural complication of the PCI that results in coronary perforation
• 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 are excluded if: They were not following verbal commands immediately prior to intubation, or They were not clearly following verbal commands after intubation within 6 hours post-PCI
• 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