Proposal for a trial of early left ventricular venting during venoarterial extracorporeal membrane oxygenation for cardiogenic shock

Abstract

Objective: Patients with profound cardiogenic shock may require venoarterial (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 left ventricle venting to enhance cardiac recovery in the setting of VA-ECMO.Methods: We describe the rationale, design, and initial testing of a randomized controlled trial of VA-ECMO with and without percutaneous left ventricle 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 left ventricle venting in improving the rate of cardiac recovery. Conclusions:The results of this nonindustry-sponsored trial will provide critical information on whether left ventricle unloading in peripheral VA-ECMO is safe and effective. (JTCVS Open 2021;8:393-400) Schematic of the REVERSE Randomized Controlled Study.

Commentary: To vent or not, that is the question

“…In December 2021 issue of JTCVS Open , Ibrahim and colleagues 1 outline the rational and design for their ongoing clinical trial at the University of Pennsylvania in “A Prospective Randomized Trial of Early LV Venting Using Impella CP for Recovery in Patients With Cardiogenic Shock Managed With VA ECMO (REVERSE Trial).” The authors are to be commended on such a difficult undertaking to answer a critical question in the field of mechanical circulatory support.…”

“…In this current manuscript, Ibrahim and colleagues 1 outline a single-institution (multicenter) randomized controlled trial to assess the safety and efficacy of early (within 24 hours of ECMO initiation) LV venting using Impella. The study design is sound and aims to answer a highly relevant clinical question.…”

Commentary: Left ventricle venting in extracorporeal membrane oxygenation: Comment on a proposed randomized trial

“…We therefore welcome and applaud the initiation of a prospective Randomized trial of Early LV Venting using Impella CP for Recovery (REVERSE) in patients with cardiogenic shock managed with VA-ECMO (described in detail elsewhere 4 ). REVERSE is a nonindustry-sponsored, single-institution randomized controlled trial comparing VA-ECMO alone to VA-ECMO with percutaneously placed Impella CP device (Abiomed) for LV venting in cardiogenic shock.…”

Commentary: Can we REVERSE the effects of venous-arterial extracorporeal membrane oxygenation in cardiogenic shock?

“…Here, we comment on the proposed Randomized Trial of Early LV Venting Using Impella CP for Recovery in patients with cardiogenic shock managed with VA ECMO (REVERSE) investigation. 4 …”

“… 5 The REVERSE investigators chose Impella, also known as “ECpella,” when combined with VA-ECMO as their LV venting strategy. 4 , 5 We are excited for the results of this trial but will pay particular attention to measures of hemolysis and renal injury with this device. Ultimately, the risk–benefit profile for each strategy must be based on the best clinical indication for a patient.…”