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. 2021 Jul 30:8:393-400.
doi: 10.1016/j.xjon.2021.07.024. eCollection 2021 Dec.

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

Michael Ibrahim  1 , Michael A Acker  1 , Wilson Szeto  1 , Jacob Gutsche  1 , Matthew Williams  1 , Pavan Atluri  1 , Matthew Woods  1 , Thomas Richards  1 , Timothy J Gardner  1 , Jeremy McGarvey  1 , Mark Epler  1 , Joyce Wald  1 , Eduardo Rame  1 , Edo Birati  1 , Christian Bermudez  1
Affiliations

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

Michael Ibrahim et al. JTCVS Open. .

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.

Keywords: LVAD, left ventricular assist device; VA-ECMO, venoarterial extracorporeal membrane oxygenation; cardiac recovery; cardiogenic shock.

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Figures

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Graphical abstract
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Schematic of the REVERSE Randomized Controlled Study.
Figure 1
Figure 1
Inclusion criteria, visual flowsheet of study, and exclusion criteria for the trial of early left ventricular venting during venoarterial extracorporeal membrane oxygenation for cardiogenic shock study. ECMO, Extracorporeal membrane oxygenation; VSD, ventricular septal defect; VA-ECMO, venoarterial extracorporeal membrane oxygenation; MCS, mechanical circulatory support; OHT, orthotopic heart transplpant; CPR, cardiopulmonary resuscitation; LVEDD, left ventricular end diastolic dimension; LVEF, left ventricular ejection fraction; AVR, aortic valve replacement; LV, left ventricle; AI, aortic insufficiency.
Figure 2
Figure 2
Visual representation of the Proposal for a trial of early left ventricular venting during venoarterial extracorporeal membrane oxygenation for cardiogenic shockstudy showing patient population, randomization to either left ventricle venting group or without, and list of primary and secondary outcomes.
See this image and copyright information in PMC

References

    1. Peura J.L., Colvin-Adams M., Francis G.S., Grady K.L., Hoffman T.M., Jessup M., et al. Recommendations for the use of mechanical circulatory support: device strategies and patient selection: a scientific statement from the American Heart Association. Circulation. 2012;126:2648–2667. - PubMed
    1. Stentz M.J., Kelley M.E., Jabaley C.S., O'Reilly-Shah V., Groff R.F., Moll V., et al. Trends in extracorporeal membrane oxygenation growth in the United States, 2011-2014. ASAIO J. 2019;65:712–717. - PubMed
    1. McCarthy F.H., McDermott K.M., Kini V., Gutsche J.T., Wald J.W., Xie D., et al. Trends in US extracorporeal membrane oxygenation use and outcomes: 2002-2012. Semin Thorac Cardiovasc Surg. 2015;27:81–88. - PMC - PubMed
    1. Cheng Y.T., Garan A.R., Sanchez J., Kurlansky P., Ando M., Cevasco M., et al. Midterm outcomes of bridge-to-recovery patients after short-term mechanical circulatory support. Ann Thorac Surg. 2019;108:524–530. - PubMed
    1. Pappalardo F., Schulte C., Pieri M., Schrage B., Contri R., Soeffker G., et al. Concomitant implantation of Impella on top of veno-arterial extracorporeal membrane oxygenation may improve survival of patients with cardiogenic shock. Eur J Heart Fail. 2017;19:404–412. - PubMed

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