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Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock - ECMO-CS
Contribution To Literature:
The ECMO-CS trial showed that use of VA-ECMO early among patients with rapidly deteriorating or severe cardiogenic shock (SCAI stages D or E) did not result in superior outcomes compared with initial conservative care.
Description:
The goal of the trial was to compare the safety and effectiveness of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) versus usual care among patients with rapidly deteriorating or severe cardiogenic shock.
Study Design
Eligible patients with shock at four centers in the Czech Republic were randomized in a 1:1 open-label fashion to either immediate VA-ECMO (n = 58) or early conservative therapy (n = 59). Other cardiovascular procedures were performed as appropriate in both arms. At the time of randomization, 14% were on intra-aortic balloon pump. Patients in the control arm could switch over to VA-ECMO for worsening hemodynamic status at the discretion of the treating physicians.
- Total number of enrollees: 117
- Duration of follow-up: 30 days
- Mean patient age: 66 years
- Percentage female: 27%
Inclusion criteria:
- Rapidly deteriorating cardiogenic shock (Society for Cardiovascular Angiography and Interventions [SCAI] shock stage D) defined as progressive hemodynamic instability necessitating repeated bolus administration of vasopressors to maintain mean arterial pressure >50 mm Hg + impaired left ventricular systolic function (left ventricular ejection fraction [LVEF] <35% or LVEF 35-55% in case of severe mitral regurgitation or aortic stenosis)
- Severe cardiogenic shock (SCAI shock stage D) defined as:
- Hemodynamic
- Cardiac index (CI) <2.2 L/min/m2 + norepinephrine dose >0.1 μg/kg/min + dobutamine dose >5 μg/kg/min
- Systolic blood pressure <100 mm Hg + norepinephrine dose >0.2 μg/kg/min + dobutamine dose >5 μg/kg/min + (LVEF <35% or LVEF 35-55% + severe mitral regurgitation or aortic stenosis)
- Metabolic
- Lactate–two consecutive values ≥3 mmol/L (with ≥30 min between samples), with non-decreasing trend on steady doses of inotropes and/or vasopressors
- SvO2–two consecutive values <50% (with ≥30 min between measurements), with non-increasing trend on steady doses of inotropes and/or vasopressors
- Central venous pressure >7 mm Hg or pulmonary capillary wedge pressure >12 mm Hg
Exclusion criteria:
- Age <18 years
- Life expectancy lower than 1 year
- High suspicion of pulmonary emboli or cardiac tamponade as a cause of shock
- Significant bradycardia or tachycardia that could be responsible for hemodynamic instability and was not treated by pacing or cardioversion
- Cardiac arrest survivors remaining comatose
- Hypertrophic obstructive cardiomyopathy
- Peripheral artery disease precluding arterial cannula insertion in the femoral artery
- Moderate to severe aortic regurgitation
- Aortic dissection
- Uncontrolled bleeding or TIMI major bleeding within last 6 months
- Known encephalopathy
Other salient features/characteristics:
- Chronic heart failure: 24%
- Blood lactate at randomization: 5 mmol/L
- Mechanical ventilation at randomization: 72%
- At baseline, use of norepinephrine: 86%, epinephrine: 3.4%, dobutamine: 54.7%, milrinone: 32.5%, vasopressin: 35%
- Cause of cardiogenic shock: ST-segment elevation myocardial infarction (STEMI): 50%, non-STEMI (NSTEMI): 12%, mechanical complication of acute MI: 2.6%
- Crossover to VA-ECMO in early conservative arm: 39%
Principal Findings:
The primary outcome, composite of all-cause mortality, implantation of another mechanical circulatory support (MCS) device, resuscitated cardiac arrest, for VA-ECMO vs. early conservative care, was: 63.8% vs. 71.2% (hazard ratio [HR] 0.72, 95% confidence interval [CI] 0.46-1.12).
- All-cause mortality: 50% vs. 47.5% (HR 1.11, 95% CI 0.66-1.87)
- Another MCS: 17.2% vs. 42.4% (HR 0.38, 95% CI 0.18-0.79)
- Resuscitated circulatory arrest: 10.3% vs. 13.6% (HR 0.79, 95% CI 0.27-2.28)
Secondary outcomes for VA-ECMO vs. early conservative care:
- Composite of all-cause mortality or resuscitated cardiac arrest: 53.4% vs. 54.2% (p > 0.05)
- Bleeding, leg ischemia, or stroke: 37.9% vs. 23.7% (p = 0.10)
Interpretation:
The results of this trial indicate that the use of VA-ECMO early among patients with cardiogenic shock (SCAI stages D or E) did not result in superior outcomes compared with initial conservative care (39% cross-over to VA-ECMO later). This study has several limitations: open-label, high crossover rates (which was part of the endpoint definition), and low use of LV venting, which might be beneficial. Despite this, it provides important data for this field/patient population in whom the use of VA-ECMO in recent years has increased dramatically despite the lack of randomized controlled trial data suggesting a clear benefit. Larger trials are ongoing.
References:
Ostadal P, Rokyta R, Karasek J, et al., on behalf of the ECMO-CS Investigators. Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock: Results of the ECMO-CS Randomized Clinical Trial. Circulation 2022;Nov 6:[Epub ahead of print].
Presented by Dr. Petr Ostadal at the American Heart Association Scientific Sessions, Chicago, IL, November 6, 2022.
Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Implantable Devices, SCD/Ventricular Arrhythmias, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Angiography, Nuclear Imaging, Mitral Regurgitation
Keywords: AHA Annual Scientific Sessions, AHA22, Angiography, Aortic Valve Stenosis, Arterial Pressure, Blood Pressure, Central Venous Pressure, Extracorporeal Membrane Oxygenation, Heart Arrest, Heart Failure, Hemodynamics, Hemorrhage, Ischemia, Mitral Valve Insufficiency, Myocardial Infarction, Respiration, Artificial, Shock, Cardiogenic, Stroke, Stroke Volume, Vasopressins, Ventilation, Ventricular Function, Left
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