Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients

Prior treatment

• Previous participation in the same study

Other illness

• Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) \> 30 min
• Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters
• Contra-indication for VA ECMO, e.g. unrecoverable heart and not a candidate for transplant or VAD

Lab values

• Lactate \> 16 mmol/L

Age

• Age \> 85 years

Other

• In case of female patients: pregnancy or lactation period
• Participation in an interventional clinical study during the preceding 30 days
• No flow time \> 5 min
• Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture)
• Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.)
• Fever (Body temperature \> 38.0 °C) or other evidence of sepsis
• Onset of cardiogenic shock \> 6 h before enrolment
• Contra-indications for anticoagulation

• Informed consent signed and dated by study patient/legal representative and investigator/authorised physician
• Minimum age of 18 years
• Patients in cardiogenic shock
• Cardiogenic shock is defined as:
  • Systolic blood pressure \< 90 mmHg for at least 30 min
  • Inotropes and/or vasopressors are needed to maintain systolic blood pressure \> 90 mmHg
  • Clinical signs of heart insufficiency with pulmonary congestion
• Signs of end organ hypoperfusion with at least one of the following criteria:
  • Cold, damp skin or extremities
  • Oliguria (≤ 30 mL/h)
• Serum lactate \> 3.0 mmol/L