For Pre-trial Phase
Inclusion Criteria:
1. Age 18-75 years old;
2. Refractory cardiogenic shock as determined by the cardiac MDT expert group; The criteria for refractory cardiogenic shock are: despite adequate doses of two vasoactive drugs and treatment of the underlying cause, there is still evidence of tissue hypoperfusion;
3. The subject can understand the purpose of the trial, voluntarily participate and sign the written informed consent form reviewed and approved by the ethics committee; the subject agrees to complete the follow-up in accordance with the protocol requirements.
Exclusion Criteria:
1. Right heart failure that meets any of the following conditions:
a Central venous pressure-capillary wedge pressure ≥10mmHg; b Central venous pressure-pulmonary artery diastolic pressure ≥10mmHg; c Cardiac tamponade.
2. Any peripheral vascular disease that prevents the placement of the trial device;
3. Left or right ventricular thrombus;
4. Aortic valve regurgitation, echocardiographic grade ≥2+;
5. Aortic valve stenosis, valve area ≤1.5cm2;
6. Aortic valve calcification;
7. Presence of mechanical aortic valve;
8. Hypertrophic or obstructive cardiomyopathy;
9. Untreated ventricular septal or atrial septal defect;
10. Patent foramen ovale;
11. Mechanical complications of acute myocardial infarction;
12. Presence of hereditary spherocytosis, hereditary elliptocytosis, autoimmune hemolytic anemia or other diseases that cause hemolysis;
13. Cardiopulmonary resuscitation lasting more than 15 minutes within 24 hours before catheter pump implantation;
14. Ventricular tachycardia or ventricular fibrillation is ineffective with drug treatment;
15. Renal failure, serum creatinine ≥309.4umol/l or blood urea nitrogen ★ ≥35.7mmol/l);
16. Liver failure (total bilirubin ≥85.5umol/l);
17. Allergy or intolerance to heparin;
18. Presence of any cardiac assist device;
19. Presence of active systemic infection;
20. Refusing to sign the informed consent form or failing to complete follow-up as required by the protocol;
21. Pregnant or lactating women, female subjects with potential fertility but unable or unwilling to use effective contraceptive measures during the study;
22. Subjects who have participated in other clinical trials within 3 months or are currently participating in other clinical trials;
23. Other situations that the investigator believes are not suitable for clinical trials.
For Formal Research Phase
Inclusion Criteria:
1. Age 18-75 years old;
2. Low cardiac output syndrome or increased filling pressure after regular continuous pumping of 1 high-dose or 2 medium-dose inotropic drugs within 48 hours after cardiopulmonary bypass was removed during cardiac surgery. The specific criteria are as follows;
The drugs, doses and time of 1 high-dose or 2 medium-dose inotropic drugs are as follows:
Epinephrine: medium dose (\<0.03 μg/kg/min), continuous pumping ≥15 minutes High dose (≥0.03 μg/kg/min), continuous pumping ≥15 minutes; Dobutamine: medium dose (\<5μg/kg/min), continuous pumping ≥15 minutes High dose (≥5μg/kg/min), continuous pumping ≥15 minutes; Milrinone: medium dose (\<0.3 μg/kg/min), continuous pumping ≥120 minutes High dose (≥0.3 μg/kg/min), continuous pumping ≥120 minutes; Low cardiac output syndrome: cardiac index 1.3≤CI≤2.2 L/min/m2;
Increased filling pressure: pulmonary capillary wedge pressure:
20≤PCWP≤30mmHg or pulmonary artery systolic pressure: 25≤PAP≤35mmHg 3) The subject can understand the purpose of the trial, voluntarily participate and sign the informed consent form reviewed and approved by the ethics committee; the subject agrees to complete the follow-up in accordance with the protocol requirements.
Exclusion Criteria:
1. Right heart failure that meets any of the following conditions:
1. Central venous pressure-capillary wedge pressure ≥10mmHg;
2. Central venous pressure-pulmonary artery diastolic pressure ≥10mmHg;
3. Cardiac ascites.
2. Any peripheral vascular disease that prevents the placement of the trial device;
3. Left or right ventricular thrombus;
4. Aortic valve regurgitation, echocardiographic grade ≥2+;
5. Aortic valve stenosis, valve area ≤1.5cm2;
6. Presence of mechanical aortic valve;
7. Hypertrophic or obstructive cardiomyopathy;
8. Untreated ventricular septal or atrial septal defect;
9. Patent foramen ovale;
10. Mechanical complications of acute myocardial infarction;
11. Suffering from diseases that cause increased blood cell fragility or hemolysis;
12. Cardiopulmonary resuscitation lasting more than 15 minutes within 24 hours before catheter pump implantation;
13. Sustained or non-sustained ventricular tachycardia or ventricular fibrillation that is unresponsive to drug treatment;
14. Renal failure, serum creatinine ≥3.5mg/dl or blood urea nitrogen ≥100mg/dl;
15. Liver failure, total bilirubin ≥5mg/dl;
16. Allergy or intolerance to heparin;
17. Other cardiac assist devices other than IABP have been implanted;
18. Active systemic infection;
19. Refuse to sign the informed consent form or fail to complete follow-up as required by the protocol;
20. Pregnant or lactating women, female subjects with potential fertility but unable or unwilling to use effective contraceptive measures during the study;
21. Subjects who are participating in other clinical trials and have not yet reached the endpoints of the trial;
22. Other situations that the investigator believes are not suitable for clinical trials.
