Rapid Impella Support and Escalation Trial
The aim of this trial is to evaluate whether a structured and time-optimized escalation strategy from a transfemoral microaxial flow-pump (Impella CP™) to the Impella 5.5™ microaxial flow-pump is associated with improved clinical outcomes and fewer adverse events in patients with cardiogenic shock due to acute myocardial infarction
• Age ≥18 years and ≤77 years
• Patients with ACS-CS (STEMI and NSTEMI with a culprit lesion that received revascularisation) and Impella CP™ support during initial revascularisation
• The following additional parameters must be met at the time of initial revascularisation procedure:
‣ Hypotension or need for inotropes AND
⁃ Lactate \> 2.5 mM AND
⁃ Left ventricular ejection fraction (EF) \< 45%
• Need for escalation to Impella 5.5 at the discretion of the treating physician and the following criteria are fulfilled:
‣ Decision for Impella 5.5 escalation within 6 ± 1 hours after completion of initial revascularisation procedure
⁃ Escalation to Impella 5.5procedure is initiated within 24 hours after completion of the initial revascularisation procedure
• Need for inotropes and/or vasopressors with VIS \> 5 but ≤ 50 at Impella CP™ support at level P7 or above at 6+1 hours after completion of initial revascularisation procedure
• Prospective Informed Consent obtained from the patient or deferred consent according to Cologne Model applied.