INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery

Exclusion Criteria

• •1. Underlying unmodifiable conditions that limit initiation of GDMT prior to enrollment, including but not limited to:
• •1. Drug allergies or hypersensitivities to HF GDMT medications, unless alternative can be identified.
• •Drug allergy/hypersensitivity is an immune-mediated reaction to a medication. Adverse reactions must be a result of immune or inflammatory cell stimulations by the mеԁiсаtion:
• •2. Known bilateral renal artery stenosis
• •3. Type 1 diabetes
• •4. 2nd or 3rd degree AV block, unless pacemaker is in place
• •5. Angioedema, hereditary or idiopathic
• •6. Pregnancy, known or confirmed by a pregnancy test if of child bearing potential.
• •2. Cardiogenic shock due to myocardial infarction prior to enrollment
• •3. Mixed shock, septic shock, or shock from non-cardiac origins
• •4. Severe Cardiogenic Shock, defined as meeting one or more of the below prior to enrollment:
• •1. SCAI stage E per Study Definition (Appendix C)
• •2. Serum lactate \> 8mmol/L
• •3. On mechanical circulatory support (not including IABP) or on mechanical ventilation for non-procedural reasons.
• •4. Experiencing pulseless electrical activity (PEA) or refractory ventricular tachycardia (VT)/ventricular fibrillation (VF)
• •5. Severe acidosis (pH \< 7.2 or bicarbonate \< 10mEq/L)
• •5. In cardiac arrest prior to enrollment
• •6. Revascularization or cardiac surgery within 90-days of the index hospitalization date or decision to undergo revascularization or cardiac surgery made prior to enrollment.
• •7. Inflammatory and infiltrative cardiomyopathy (CM) including myocarditis, restrictive CM, constrictive pericarditis, or hypertrophic CM including sarcoidosis and amyloidosis.
• •8. Adult congenital heart disease without appropriate surgical correction
• •9. Structural or anatomical abnormalities that cannot be modified as determined by the treating cardiologist, including severe primary mitral regurgitation (MR) .
• •10. Severe RV dysfunction, per Study Definition (Appendix C), requiring mechanical or inotropic support prior to enrollment.
• •11. Severe dilatation of the LV with LVEDD greater than 8.0cm
• •12. History of heart transplant or listed for heart transplant prior to enrollment.
• •13. Planned to be implanted with a permanent VAD within 90-days of the index hospitalization date.
• •14. Continuous outpatient inotropic support prior to the index hospitalization date.
• •15. Planned to pursue palliative care or hospice, or life expectancy of less than 2 years due to non-cardiac illness at the time of index hospitalization date.
• •16. ICD upgrade to BiV, or implantation of CRT within 30-days of the index hospitalization date.
• •17. Currently on dialysis, or has pre-existing end-stage chronic kidney disease (stage 4 or above), or has hereditary, infectious, or autoimmune nephropathy.
• •18. Pre-existing liver dysfunction defined as: presence of liver cirrhosis or alcoholic hepatitis, or presence of acute liver failure or acute hepatitis not due to cardiogenic shock.
• •19. Pre-existing pulmonary disease requiring home oxygen
• •20. History of stroke or intracranial hemorrhage ≤ 90 days of the index hospitalization date, or a history of cerebrovascular disease with significant (\> 80%) uncorrected carotid stenosis, or any permanent neurological deficit with mRS score \>2.
• •21. Any contraindication that precludes placing an Impella 5.5®, including but not limited to:
• •1. Aortic valve stenosis/calcification with orifice area ≤0.6cm2 or aortic insufficiency of any grade greater than mild on pre-procedure echocardiography.
• •2. Presence of mechanical aortic valve or heart constrictive device.
• •3. Thrombus in the left atrium or ventricle.
• •4. Infection of the planned procedural access site or suspected systemic active infection.
• •5. Severe arterial disease precluding placement of Impella.
• •6. Presence of Atrial or Ventricular Septal Defect (including post-infarct VSD)
• •7. Left ventricular rupture
• •8. Cardiac tamponade I. Combined cardiorespiratory failure
• •22. Known contraindication to heparin (i.e., heparin induced thrombocytopenia (HIT)) or intolerance to anticoagulant or antiplatelet therapies.
• •23. Allergies or contraindications to contrast agents unless can be adequately medicated.
• •24. History of bleeding diathesis or known coagulopathy, any GU or GI bleed within 90-days of the index hospitalization date or will refuse blood transfusions.
• •25. Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures.
• •26. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not met its primary endpoint.
• •27. Subject belongs to a vulnerable population, such as such as prisoners, individuals with impaired decision making, or economically or educationally disadvantaged persons.
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