Hot Line: Does early extracorporeal life support improve survival in patients with MI and cardiogenic shock?
27 Aug 2023
In a Hot Line session yesterday, Professor Holger Thiele (Heart Centre Leipzig at University of Leipzig - Leipzig, Germany) presented results from ECLS-SHOCK, the first randomised trial to investigate the effect of extracorporeal life support (ECLS) on mortality in patients with acute myocardial infarction (MI) complicated by cardiogenic shock.1
Mortality rates remain high in patients with cardiogenic shock secondary to acute MI, reaching 40–50% within 30 days,2 and this has led to an increase in the use of active mechanical circulatory support devices to achieve haemodynamic stabilisation in severe shock. In particular, the use of ECLS – venoarterial extracorporeal membrane oxygenation (VA-ECMO) – has risen by more than 10 times in recent years.3 However, evidence for ECLS is restricted to observational studies and three small, randomised trials.4–7 The potential benefits of haemodynamic support might be outweighed by a considerable risk of device-associated local and systemic complications including bleeding, stroke, limb ischaemia and haemolysis. With a primary endpoint of 30-day mortality, the ECLS-SHOCK randomised trial was conducted to provide conclusive evidence in favour of or against ECLS.
The final analysis included 417 patients with acute MI and cardiogenic shock scheduled for early revascularisation in centres across Germany and Slovenia who were randomised to early ECLS plus usual medical treatment or usual medical treatment alone. The median age of participants was 63 years and 19% were women.
At 30 days, all-cause death occurred in 47.8% of patients in the ECLS group and 49.0% of patients in the control group (relative risk [RR] 0.98; 95% CI 0.80 to 1.19; p=0.81).
Regarding secondary endpoints, the median duration of mechanical ventilation was longer in the ECLS group: 7 days (interquartile range [IQR] 4–12) in the ECLS group versus 5 days (IQR 3–9) in the control group, with a Hodges-Lehmann estimate of the difference between the groups of 1 (95% CI 0 to 2). The time to haemodynamic stabilisation and rates of renal replacement therapy were similar between treatment groups.
Safety endpoints were not favourable with ECLS. Moderate or severe bleeding occurred more frequently with ECLS than usual care (23.4% versus 9.6%; RR 2.44; 95% CI 1.50 to 3.95). Furthermore, peripheral vascular complications requiring intervention also occurred more often in the ECLS group (11.0% versus 3.8%; RR 2.86; 95% CI 1.31 to 6.25).
Prof. Thiele concludes, “The results of ECLS-SHOCK demonstrated no reduction in 30-day mortality with early ECLS therapy and an increase in complications. The findings may lead to the discontinued routine use of these devices in clinical practice.”
References
- Thiele H, et al. Am Heart J. 2021;234:1–11.
- Thiele H, et al. Eur Heart J. 2019;40:2671–2683.
- Becher PM, et al. Circulation. 2018;138:2298–2300.
- Ostadal P, et al. Circulation. 2023;147:454–464.
- Brunner S, et al. J Am Coll Card. 2019;73:2355–2357.
- Ouweneel DM, et al. Intensive Care Med. 2016;42:1922–1934.
- Banning AS, et al. EuroIntervention. 2023 May 19. Online ahead of print.
