Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock

Study Overview
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Brief Summary
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A Clinical Events Committee (CEC) will include Cardiac Surgery Professor and chief of cardiac surgery Rose Kelly MD, Professor of Medicine Ganesh Raveendran MD at the University of Minnesota who is the direction of Interventional Cardiology and Professor of Medicine at the University of Minnesota David Benditt. They will review and adjudicate serious and unexpected adverse events independently from the PI and co investigators.

Official Title
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Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock

Conditions
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Acute Coronary Syndrome, Cardiogenic Shock

Intervention / Treatment
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* Other: Physiological Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years SCAI D/E CS requiring VA-ECMO support based on treating team's judgement. MAP >65 mmHg on <3 vasopressors/inotropes at the time of consent Cardiogenic shock due to acute coronary syndrome identified by coronary angiography at the index hospitalization per standard cardiology practice Exclusion Criteria: VA-ECMO for sepsis, pulmonary embolism, COVID-19 related cardiorespiratory failure, severe RV failure due to severe idiopathic pulmonary hypertension CS due to other (non-ACS) etiologies Known patient with severe left ventricular dysfunction and stage IV NYHA heart failure being evaluated for or with a history of LVAD and transplantation prior to commencement of VA-ECMO Profound vasoplegia with MAP <65 mmHg on 3 vasopressors/inotropes Moderate to severe aortic regurgitation (contraindication to VA-ECMO) Moderate to severe aortic stenosis (contraindication to LV instrumentation with PV loop catheter) Bleeding complications requiring ongoing transfusions of blood products Ischemic lower extremities Evidence of circuit thrombosis or fibrin accumulation (turndown increases risk for stroke and clot formation) Evidence of sepsis or septic shock Evidence of LV thrombus on echocardiography (contraindication for accessing LV cavity with catheters)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Physiological Assessment<br>Prospective physiological assessment of LV work and oxygen consumption in patients with SCAI D/E cardiogenic shock due to acute coronary syndrome treated with peripheral VA-ECMO support. | Other: Physiological Assessment<br>* Observational only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure-volume loops at the highest level of VA-ECMO support and the lowest level of VA-ECMO support. | Pressure-volume loops at the highest level of VA-ECMO support and the lowest level of VA-ECMO support. | Day 3 of ECMO | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, Cardiogenic Shock, Left ventricle, VA-ECMO