The effects of mechanical left ventricular unloading during ExtraCorporeal Membrane Oxygenation (ECMO), a Registry Based Randomized Clinical Trial

Project summary

Cardiogenic shock, which can arise as an acute final common pathway of many heart diseases, threatens the lives of about 50 per 100,000 patients per year. Luckily, patients now have long term prospects of survival and quality of life thanks to the rapid evolution of heart failure drugs and mechanical left ventricular assist devices. To profit from these therapies, patients must survive an initial critical phase of severe illness. This initial phase can be successfully bridged by creating a temporary parallel circulation through application of cardiopulmonary bypass for prolonged periods of time, called “ExtraCorporeal Membrane Oxygenation (ECMO)”.

Despite the lifesaving effects of ECMO, even today, up to 50 percent of patients will not survive one year. This high mortality rate is in part attributable to the occurrence of major complications such as intracardiac thrombosis, pulmonary oedema and eventually, failure of the heart to recover. These complications are considered to be caused by the unnatural blood flow of the ECMO circuit parallel to that of the native heart, hampering the left ventricle to eject blood and recover. This extra burden can be alleviated by concomitant implantation of one of the following devices: 1) an IntraAortic Balloon counterPulsation (IABP) or 2) transaortic axial pump (Impella). Both devices “unload the left ventricle” and can potentially reduce ECMO support duration and improve survival and quality of life.

I hypothesize that: 1) by unloading the left ventricle, IABP and Impella will increase ECMO weaning success, and improve survival and quality of life. 2) IABP is non-inferior to Impella with regards to these end points. This project contains the development and implementation of a Registry Based Randomized Clinical Trial (RB-RCT) platform that will investigate the effects of IABP versus Impella versus ECMO alone on ECMO weaning success, mortality and quality of life in ECMO supported cardiogenic shock patients.

The implementation of this RB-RCT for the conduction of trials fills an identified unmet medical need. Moreover it will serve as a basis for nesting future simultaneous and/or subsequent trials covering other relevant therapeutic questions regarding ECMO management.