Proposal for a trial of early left ventricular venting with venous-arterial extracorporeal membrane oxygenation for cardiogenic shock

Abstract Objective Patients with profound cardiogenic shock may require veno-arterial (VA) extracorporeal membrane oxygenation (ECMO) for circulatory support most commonly via the femoral vessels. The rate of cardiac recovery in this population remains low, possibly because peripheral VA-ECMO increases ventricular afterload. Whether direct ventricular unloading in peripheral VA-ECMO enhances cardiac recovery is unknown, but is being more frequently utilized. A randomized trial is warranted to evaluate the clinical effectiveness of percutaneous LV venting to enhance cardiac recovery in the setting of VA-ECMO. Methods We here describe the rationale, design and initial testing of a randomized controlled trial of VA-ECMO with and without percutaneous LV venting using a percutaneous micro-axial ventricular assist device. Results This is an ongoing prospective randomized controlled trial in adult patients with primary cardiac failure presenting in cardiogenic shock requiring peripheral VA-ECMO, designed to test the safety and effectiveness of percutaneous LV venting in improving the rate of cardiac recovery. Conclusion The results of this non-industry sponsored trial will provide critical information on whether LV unloading in peripheral VA-ECMO is safe and effective.