6.2
Instructions for Use & Clinical Reference Manual (US)
Exclusion Criteria
Specific to Cohort A:
1. INTERMACS 1 patients (Critical cardiogenic shock patient who is “crashing and burning,” has
life-threatening hypotension and rapidly escalating inotropic or pressor support, with critical
organ hypoperfusion often confirmed by worsening acidosis and lactate levels)
2. End organ failure (defined as hepatic total bilirubin
≥ 5 mg/dL based on lab data within 24
hours prior to Impella RP initiation, renal: creatinine
≥ 4 mg/dL based on lab data within the 24
hours prior to Impella RP initiation)
3. Evidence of acute neurologic injury following LVAD implant
Specific to Cohort B:
1. Patient in profound cardiogenic shock defined as systolic blood pressure< 75 mmHg and CI
<1.3 l/min/m
2
despite 2 or more high dose of inotropes ± mechanical support or evidence of
shock-related end-organ damage, metabolic acidosis (pH 7.1 or less) and not corrected by 100
ml NaHCO3 (1mEq/ml), disseminated intravascular coagulation or clinical evidence of diffuse
brain injury or in cardiogenic shock for >24 hours.
2. AMI with mechanical complications (ventricular septal defect, myocardial rupture, papillary
muscle rupture)
3. Unsuccessful revascularization of the RCA (TIMI 0.1 post PCI or post-CABG)
General – For Both Cohorts
1. Active infection, two of the following WBC>12,500, positive blood culture, fever
2. RA, RV and/or PA thrombus
3. Prosthetic valves in the right heart (tricuspid or pulmonary valves)
4. Unrepaired atrial septal defect/ patent foramen ovale
5. Structural tricuspid valve disease
6. Severe pulmonary valve stenosis or insufficiency
7. Intolerance to anticoagulant or antiplatelet therapies
8. Severe pulmonary hypertension (PAP>60mmHg)
9. Documented DVT and/or presence of IVC filter
10. Anatomic conditions precluding insertion of the pump or safe use of the device such as severe
anomaly of the inferior vena cava, calcification or other disorders of the pulmonary artery wall
11. Pulmonary artery conduit replacement
12. Patient on right side support device or extracorporeal membrane oxygenation
13. Current diagnosis of pulmonary embolism
14. Patient with anatomic anomalies or aortic diseases like aortic dissection, Marfan-Syndrome,
Morbus Erdheim-Gsell or others
15. Allergy or intolerance to contrast media
16. Thrombolysis within the previous 30 days or known existing coagulopathy such as
thrombocytopenia, heparin induced thrombocytopenia (HIT), hemoglobin diseases such as
sickle cell anemia or thalassemia
17. Existing congenital heart disease precluding device insertion
18. Participation in any other clinical investigation that is likely to confound study results or affect
study outcome
