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Outcome of patients treated with extracorporeal life support in cardiogenic shock complicating acute myocardial infarction: 1-year result from the ECLS-Shock study

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Abstract

Background

Treatment with extracorporeal life support (ECLS) in acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) fell short of improving myocardial recovery measured by 30 day ejection fraction in the ECLS-SHOCK trial. However, to date, no data regarding impact of ECLS on long-term outcomes exist.

Methods

In this randomized, controlled, prospective, open-label trial, 42 patients with CS complicating AMI were randomly assigned to ECLS (ECLS group, n = 21) or no ECLS (control group, n = 21). The primary endpoint was left ventricular ejection fraction (LVEF) after 30 days. Secondary endpoints included mortality and neurological outcome after 12 months. Evaluation of neurological outcome used the modified Rankin Scale.

Results

The 12-month all-cause mortality was 19% in the ECLS group versus 38% in the control group (p = 0.31). Only one patient (control group) died after the initial 30 days. Three patients underwent elective percutaneous coronary intervention (PCI) during follow-up (one in the control and two in the ECLS group). Favorable neurological outcome (modified Rankin Score ≤ 2) was seen in 61.9% of patients in the ECLS group versus 57.1% in the control group (p = 1).

Conclusion

This pilot study showed that randomized studies with ECLS in CS patients are feasible and safe. Small numbers of included patients impede meaningful conclusions about mortality and neurological outcome. Our findings of numerical differences in mortality and survival with severe neurological impairment give an urgent call for larger multi-centric randomized trials assessing the endpoint of all-cause mortality but also considering the effects on neurological outcome measures.

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Availability of data and material

The R Code of our analysis was submitted to the journal and is available on request.

Abbreviations

AMI:

Acute myocardial infarction

CABG:

Coronary artery bypass graft

CAD:

Coronary artery disease

CS:

Cardiogenic shock

ECLS:

Extracorporeal life support

IABP:

Intra-aortic balloon pumping

IQR:

Interquartile range

LVEF:

Left ventricular ejection fraction

MACE:

Major adverse cardiac event

PCI:

Percutaneous coronary intervention

PCAS:

Post-cardiac arrest syndrome

PRMD:

Post resuscitation myocardial dysfunction

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Funding

LivaNova (Munich, Germany) supported the study, but did not have any involvement in trial design or evaluation.

Author information

Authors and Affiliations

  1. Department of Medicine I, Munich University Hospital, Ludwig-Maximilian-University, Marchioninistr. 15, 81377, Munich, Germany

    Korbinian Lackermair, Stefan Brunner, Mathias Orban, Martin Orban, Hans D. Theiss, Bruno C. Huber, Axel Bauer, Jörg Hausleiter & Steffen Massberg

  2. Department of Cardiac Surgery, Munich University Hospital, Ludwig-Maximilian-University, Marchioninistr. 15, 81377, Munich, Germany

    Sven Peterss, Gerd Juchem, Frank Born, Maximilian Pichlmaier, Christian Hagl & Sabina P. W. Guenther

  3. Institute for Medical Information Processing, Biometry and Epidemiology (IBE), Ludwig-Maximilian-University, Munich, Germany

    Anne-Laure Boulesteix

  4. Munich Heart Alliance, German Centre for Cardiovascular Research, Munich, Germany

    Axel Bauer, Jörg Hausleiter, Steffen Massberg & Christian Hagl

  5. Department of Cardiology, University Hospital Innsbruck, Innsbruck, Austria

    Axel Bauer

Authors
  1. Korbinian Lackermair
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  2. Stefan Brunner
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Contributions

KL (conception and design or analysis and interpretation of data, drafting of the manuscript or revising it critically for important intellectual content), SB (conception and design or analysis and interpretation of data, drafting of the manuscript or revising it critically for important intellectual content), MO (final approval of the manuscript submitted), SP (final approval of the manuscript submitted), MO (final approval of the manuscript submitted), HDT (conception and design or analysis and interpretation of data), BCH (final approval of the manuscript submitted), GJ (final approval of the manuscript submitted), FB (conception and design or analysis and interpretation of data), A-LB (conception and design or analysis and interpretation of data), AB (conception and design or analysis and interpretation of data), MP (conception and design or analysis and interpretation of data), JH (conception and design or analysis and interpretation of data, drafting of the manuscript or revising it critically for important intellectual content), SM (conception and design or analysis and interpretation of data, drafting of the manuscript or revising it critically for important intellectual content), CH (conception and design or analysis and interpretation of data), SPWG (conception and design or analysis and interpretation of data, final approval of the manuscript submitted).

Corresponding authors

Correspondence to Steffen Massberg or Christian Hagl.

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Lackermair, K., Brunner, S., Orban, M. et al. Outcome of patients treated with extracorporeal life support in cardiogenic shock complicating acute myocardial infarction: 1-year result from the ECLS-Shock study. Clin Res Cardiol 110, 1412–1420 (2021). https://doi.org/10.1007/s00392-020-01778-8

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