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Clinical Trial
. 2021 Sep;110(9):1412-1420.
doi: 10.1007/s00392-020-01778-8. Epub 2020 Nov 12.

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

Korbinian Lackermair  1 , Stefan Brunner  1 , Mathias Orban  1 , Sven Peterss  2 , Martin Orban  1 , Hans D Theiss  1 , Bruno C Huber  1 , Gerd Juchem  2 , Frank Born  2 , Anne-Laure Boulesteix  3 , Axel Bauer  1   4   5 , Maximilian Pichlmaier  2 , Jörg Hausleiter  1   4 , Steffen Massberg  6   7 , Christian Hagl  8   9 , Sabina P W Guenther  2
Affiliations
Clinical Trial

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

Korbinian Lackermair et al. Clin Res Cardiol. 2021 Sep.

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.

Keywords: Acute myocardial infarction; Cardiogenic shock; ECLS; Neurological outcome.

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