Unloading in Heart Failure Cardiogenic Shock

To demonstrate the efficacy of timely temporary mechanical left ventricular unloading with the Impella 5.5® assist device in patients with acute decompensated heart failure complicated by cardiogenic shock (ADHF-CS) vs. current standard of (pharmacological) care

Inclusion criteria

• Evidence of HFrEF according to ESC HF guidelines (LVEF ≤ 35%) 2. Signs of (persistent) congestion (elevated CVP, edema, rales, ascites, pleural effusion) 3. Evidence of CS with presence of at least 2 of the 3 following:

• Hypotension

• systolic blood pressure <90 mmHg for at least 30 min OR
• mean arterial pressure <60 mmHg for at least 30 min
• Hypoperfusion

• lactate > 2.0 mmol/L (two consecutive values > 2 mmol/L with at least 30 min between samples, with non-decreasing trend on if on (steady doses of) inotropes and/or vasopressors)
• amino-L-transferase >200 U/L (two consecutive values > 200 Ul/L with at least 30 min between samples, with non-decreasing trend if on (steady doses of) inotropes and/or vasopressors)
• creatinine rise ≥ 0.3 mg/dl/24h ( 26,53 μmol/L)
• oliguria (≤ 0,5 ml/kg/h, ≤ 720 ml/24 h)
• Inotropes/vasoactives (use of)

Exclusion criteria

• Contraindications for Impella 5.5
• Severe concomitant RV failure
• Grade IV mitral regurgitation eligible for surgical treatment
• Dialysis for end-stage renal failure
• Acute coronary syndrome (type 1, AMI)
• Bradycardia and AV blocks necessitating pacemaker implantation
• HD parameters and biochemistry alterations as specifically defined for SCAI CS E
• Combined cardiorespiratory failure
• Resuscitated (OHCA/PEA)
• History of CVA or TIA within previous 90 days
• History of acute myocardial infarction within previous 30 days
• History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions
• Inflammatory
• Active systemic infections
• Acute myocarditis