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Published on: May 15, 2020
Outcomes of ECLS-SHOCK Eligibility Criteria Applied to a Real-World Cohort
Dirk von Lewinski1, Lukas Herold1, Eva Bachl1
1Department of Internal Medicine, Division of Cardiology, Medical University of Graz, Auenbruggerplatz 15, 8036 Graz, Austria.
Insights
Only 38% of patients with myocardial infarction-related cardiogenic shock met ECLS-SHOCK trial criteria. Real-world outcomes differed, suggesting VA-ECMO trial results may not generalize to diverse patient populations.
Area of Science:
- Cardiology
- Critical Care Medicine
- Medical Device Technology
Background:
- Cardiogenic shock (CS) has a high in-hospital mortality rate of approximately 50%.
- The ECLS-SHOCK trial found veno-arterial extracorporeal membrane oxygenation (VA-ECMO) had neutral effects on mortality and secondary outcomes in myocardial infarction (MI)-related CS.
- Real-world applicability of ECLS-SHOCK trial findings requires comparison with broader patient cohorts.
Purpose of the Study:
- To compare the eligibility criteria of the ECLS-SHOCK trial with a real-world cohort of CS patients.
- To assess the generalizability of ECLS-SHOCK trial findings to a diverse patient population.
- To evaluate differences in baseline characteristics and outcomes between trial-eligible and non-eligible CS patients.
Main Methods:
- Applied ECLS-SHOCK eligibility criteria to 557 patients in the PREPARE CS registry (SCAI C-E).
- Analyzed mechanical circulatory support (MCS) use, MI-related CS prevalence, and reasons for exclusion from the ECLS-SHOCK trial.
- Compared 30-day mortality between ECLS-SHOCK eligible and non-eligible patients in the real-world cohort and with trial data.
Main Results:
- Only 38% of the real-world CS cohort met ECLS-SHOCK eligibility criteria.
- Exclusion reasons included low initial lactate (43.6%), age over 80 (16.9%), and prolonged CPR >45 min (5.7%).
- Thirty-day mortality for ECLS-SHOCK eligible patients in the real-world cohort was 57.0%, versus 48.4% in the ECLS-SHOCK trial, with differing baseline characteristics.
Conclusions:
- A significant proportion of real-world MI-related CS patients do not meet ECLS-SHOCK trial eligibility criteria.
- The heterogeneity of the real-world CS population may impact the generalizability of VA-ECMO trial outcomes.
- Further research is needed to understand VA-ECMO's impact in diverse, real-world CS patient populations.
Background:
Cardiogenic shock (CS) exhibits high (~50%) in-hospital mortality. The recently published Extracorporeal life Support in Cardiogenic Shock (ECLS-SHOCK) trial demonstrated the neutral effects of the use of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) on all-cause death, as well as on all secondary outcomes in subjects presenting with myocardial-infarction (MI)-related CS. Here, we compared ECLS-SHOCK eligibility criteria with a real-world cohort of CS patients.
Methods And Results:
ECLS-SHOCK eligibility criteria were applied to a prospective single-center CS registry (the PREPARE CS registry) consisting of 557 patients who were consecutively admitted to the catheterization laboratory (cath lab) of the Medical University of Graz, Austria, due to CS (SCAI C-E). Overall use of mechanical circulatory support (MCS) in this cohort was 19%. Sixty-nine percent of the entire cohort had MI-related CS, 38% of whom would have met ECLS-SHOCK eligibility criteria, thus representing only 27% of the PREPARE CS registry. Exclusion from the ECLS-SHOCK trial was based on patients with initial lactate values below 3 mmol/L (n = 168; 43.6%), aged over 80 years (n = 65; 16.9%), and with a duration of cardiopulmonary resuscitation (CPR) exceeding 45 min (n = 22; 5.7%). The 30-day mortality of patients of the PREPARE CS registry who met the ECLS-SHOCK eligibility criteria was 57.0%, compared to 48.4% of patients in the ECLS-SHOCK trial. The patients' baseline characteristics, however, differed considerably with respect to type of infarction, age, and gender.
Conclusions:
In a real-world cohort of patients with MI-related CS, only 38% of patients met the eligibility criteria of the ECLS-SHOCK trial. Thus, the impact of the use of VA-ECMO on outcome parameters in MI-related CS, as observed in the ECLS-SHOCK trial, may differ in a more heterogeneous real-world CS population of the PREPARE CS registry.
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