ExtraCorporeal Life Support for acute myocardial infarction complicated by cardiogenic shock - ECLS-SHOCK

Nov 11, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Trial Sponsor:
Else Kröner Fresenius Foundation; German Heart Research Foundation; Helios Health Institute
Date Presented:
11/11/2023
Date Published:
08/26/2023
Date Updated:
11/11/2023
Original Posted Date:
08/26/2023
References

Contribution To Literature:

Highlighted text has been updated as of November 11, 2023.

The ECLS-SHOCK trial failed to show that ECLS during acute MI and cardiogenic shock improves 30-day mortality.

Description:

The goal of the trial was to evaluate extracorporeal life support (ECLS) compared with control among patients with acute myocardial infarction (MI) and cardiogenic shock.

Study Design

  • Randomized
  • Parallel

Patients with acute MI and cardiogenic shock were randomized to ECLS (n = 211) vs. usual care (n = 209).

  • Total number of enrollees: 420
  • Duration of follow-up: 30 days
  • Mean patient age: 62 years
  • Percentage female: 19%

Inclusion criteria:

  • Acute MI and cardiogenic shock
  • Planned revascularization
  • Systolic blood pressure <90 mm Hg or vasoactive drugs to support blood pressure
  • Impaired organ perfusion with 1) altered mental status, 2) cold/clammy skin, or 3) urine output <30 cc/hour
  • Lactate >3 mmol/L

Exclusion criteria:

  • Resuscitation >45 minutes
  • Mechanical cause of cardiogenic shock
  • Onset of shock >12 hours
  • Severe peripheral artery disease
  • <18 years or >80 years of age
  • Noncardiogenic shock
  • Limited life expectancy for another reason
  • Pregnancy

Other salient features/characteristics:

  • ECLS was performed prior to revascularization in 22%, during revascularization in 26%, and after revascularization in 52%
  • Distal perfusion catheter, 95%
  • Left ventricular unloading, 5.8%

Principal Findings:

The primary outcome, 30-day mortality, was 47.8% in the ECLS group vs. 49.0% in the usual care group (p = 0.81).

Secondary outcomes:

  • Moderate or severe bleeding: 23.4% in the ECLS group vs. 9.6% in the usual care group (p < 0.05)
  • Vascular complication requiring surgery or intervention: 11.0% in the ECLS group vs. 3.8% in the usual care group (p < 0.05)

Outcomes according to cardiac arrest pre-randomization:

  • 324 subjects had cardiac arrest with cardiopulmonary bypass prior to randomization
  • Subgroup analysis reported as odds ratio (OR) for ECLS vs. control, according to cardiac arrest status
  • Mortality: OR 1.00 (95% confidence interval [CI] 0.65-1.55) for cardiac arrest, OR 0.81 (95% CI 0.36-1.82) without cardiac arrest (p for interaction = 0.65)
  • Peripheral vascular complication: OR 3.05 (95% CI 1.17-7.94) for cardiac arrest, OR 3.22 (95% CI 0.61-16.86) without cardiac arrest (p for interaction = 0.96)
  • Major bleeding: OR 2.58 (95% CI 1.46-4.58) for cardiac arrest, OR 2.83 (95% CI 0.98-8.18) without cardiac arrest (p for interaction = 0.88)

Interpretation:

Among patients with acute MI, ECLS failed to improve 30-day survival. ECLS was also associated with safety concerns due to an increased incidence of moderate or severe bleeding. Serious vascular complications were also increased with ECLS. Findings were the same regardless of pre-randomization cardiac arrest status. Despite lack of evidence, there has been increased use of ECLS. Accordingly, this study will challenge an ECLS strategy during acute MI and cardiogenic shock.

References:

Presented by Dr. Uwe Zeymer at the American Heart Association Scientific Sessions, Philadelphia, PA, November 11, 2023.

Thiele H, Zeymer U, Akin I, et al., on behalf of the ECLS-SHOCK Investigators. Extracorporeal Life Support in Infarct-Related Cardiogenic Shock. N Engl J Med 2023;389:1286-97.

Editorial: Leopold JA, Taichman DB. Routine Early ECLS in Infarct-Related Cardiogenic Shock? N Engl J Med 2023;389:1331-2.

Presented by Dr. Holger Thiele at the European Society of Cardiology Congress, Amsterdam, Netherlands, August 26, 2023.

Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Implantable Devices, SCD/Ventricular Arrhythmias, Acute Heart Failure

Keywords: Acute Coronary Syndrome, AHA23, Heart Arrest, Shock, Cardiogenic


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