Key Points:
- The 30-day ECLS SHOCK study demonstrated no benefit to up-front ECLS in the reduction of 30-day mortality in acute, infarct-related cardiogenic shock.
- At one year, there were similarly no differences in the primary endpoint of all-cause mortality between ECLS and control. Additionally, there were no differences in the secondary outcomes of CV mortality, readmissions, and repeat revascularization.
- Patients receiving ECLS had significantly higher moderate or extreme pain at one year relative to those in the control arm, with no differences in other quality of life measures.
While cardiogenic shock mortality has not improved over the past decade, utilization of VA-ECMO and other forms of extracorporeal life support (ECLS) has increased rapidly. The 30-day results of ECLS SHOCK cast doubt on the up-front utilization of ECLS in acute-MI-related cardiogenic shock. In a breaking presentation at the 2024 ESC Congress today, Dr. Steffen Desch and his team presented “Extracorporeal life support for acute myocardial infarction complicated by cardiogenic shock – 12 months results of the ECLS-SHOCK trial.”
The ECLS-SHOCK study (NCT03637205) was a randomized, multicenter trial of patients with acute MI and cardiogenic shock treated with either up-front ECLS or randomized to the control arm. Participants were required to have cardiogenic shock complicating an acute MI with the addition of a) planned revascularization, b) sBP <90mm Hg or catecholamines required to maintain a sBP>90mm Hg, c) signs of impaired organ perfusion, and d) arterial lactate > 3mmol/L. Key exclusion criteria were resuscitation lasting >45 minutes, onset of shock >12 hours ago, a mechanical cause of shock, severe PAD precluding cannulation, and severe concomitant disease with a limited life expectancy < 6 months. The primary endpoint was 30-day all-cause mortality.
A total of 420 patients were 1:1 randomized to ECLS or control. The mean age was 62, 19% were women, and 67% presented with a STEMI. The median ejection fraction was 30%, and half presented in SCAI C shock. In keeping with the 30-day results, participants receiving ECLS had no difference in the primary endpoint of all-cause mortality at one year (HR 0.94, 95% CI 0.73-1.22). There were also no significant differences in myocardial reinfarction, CV mortality, repeat revascularization, rehospitalization for HF, or poor neurological outcomes amongst survivors (all p>0.05). Quality of life was similar between groups, with no significant differences in mobility, self-care, usual activities, or anxiety/depression between groups (p>0.05); however, individuals who had received ECLS were more likely to have pain/discomfort at one year (7.2% vs 3.7% for extreme pain and 31.3% vs 17.1% for moderate pain; p =0.013).
When discussing the clinical implications of the study at the ESC Dr. Desch stated: “At one year follow-up, ECLS therapy does not provide clinical benefit compared to optimal medical therapy alone in patients with severe infarct-related cardiogenic shock.”
