Outcome of patients treated with extracorporeal life support in cardiogenic shock complicating acute myocardial infarcti
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ORIGINAL PAPER
Outcome of patients treated with extracorporeal life support in cardiogenic shock complicating acute myocardial infarction: 1-year result from the ECLS-Shock study Korbinian Lackermair1 · Stefan Brunner1 · Mathias Orban1 · Sven Peterss2 · Martin Orban1 · Hans D. Theiss1 · Bruno C. Huber1 · Gerd Juchem2 · Frank Born2 · Anne‑Laure Boulesteix3 · Axel Bauer1,4,5 · Maximilian Pichlmaier2 · Jörg Hausleiter1,4 · Steffen Massberg1,4 · Christian Hagl2,4 · Sabina P. W. Guenther2 Received: 22 September 2020 / Accepted: 30 October 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020
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.
* Steffen Massberg [email protected]‑muenchen.de * Christian Hagl [email protected]‑muenchen.de 1
Department of Medicine I, Munich University Hospital, Ludwig-Maximilian-University, Marchioninistr. 15, 81377 Munich, Germany
2
Department of Cardiac Surgery, Munich University Hospital, Ludwig-Maximilian-University, Marchioninistr. 15, 81377 Munich, Germany
3
Institute for Medical Information Processing, Biometry and Epidemiology (IBE), Ludwig-Maximilian-University, Munich, Germany
4
Munich Heart Alliance, German Centre for Cardiovascular Research, Munich, Germany
5
Department of Cardiology, University Hospital Innsbruck, Innsbruck, Austria
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Vol.:(0123456789)
Clinical Research in Cardiology
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