Impella CP With VA ECMO for Cardiogenic Shock

Study Summary

Veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) is indicated as a haemodynamic rescue strategy in decompensated acute or chronic heart failure presenting as cardiogenic shock. It has been used across aeitologies including post-myocardial infarction, dilated cardiomyopathy, acute myocarditis and in post-cardiotomy shock. VA ECMO has a number of effects on the circulation including improved end-organ perfusion and possibly improved coronary perfusion, and is a bridge to further therapies including permanent advanced mechanical circulatory support, cardiac transplantation and to cardiac recovery. Left ventricular assist devices (LVADs) provide long-term mechanical circulatory support and also profoundly mechanically unload the left ventricle. Multiple clinical studies have documented cardiac recovery using LVAD therapy, with a rate between 10-60% in selected populations. A large body of basic science has documented the pivotal role of mechanical load in determining ventricular contractile performance across species. Therefore both clinical data and basic laboratory studies support the notion that profound ventricular unloading may result in improved cardiac performance through a variety of mechanisms ranging from triggered de novo cardiomyocyte proliferation, subcellular calcium handling reverse remodeling, changes to the extracellular matrix of the heart, reverse remodeling of the neurohormal milleu, amongst many others. One of the major deficiencies of peripheral VA-ECMO is its lack of left ventricular unloading, with associated pulmonary congestion, which can derail clinical improvement and hamper cardiac recovery. Indeed, percutaneous VA-ECMO increases LV afterload due to the retrograde blood flow, and because of the lack of venting, there may be progressive LV distension. These conditions can result in a congested, pressure-overloaded ventricle, even in the absence of echocardiographic ventricular distension. This may be ameliorated with the additio

Primary Outcome

The number of subjects treated with this standardized ECMO protocol with either (i) no additional therapy or (ii) Impella CP for LV mechanical unloading who experience myocardial recovery defined as: survival free from mechanical circulatory support, heart transplantation or inotropic support.

Interventions

• DEVICE Impella-CP LV Vent