Outcomes of ECLS-SHOCK Eligibility Criteria Applied to a Real-World Cohort

Abstract

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.

The Management of Cardiogenic Shock From Diagnosis to Devices

“…In considering translatability to a real-world cohort of patients with AMI-CS, > 60% would not have met eligibility for the trial, so there may be populations in which venoarterial ECMO could be expected more reasonably to alter outcomes. 94 Venoarterial ECMO should be reserved for carefully selected patients with AMI-CS, and especially those whose disease is refractory to medical management alone. 95 Finally, the trial results are limited in their generalizability and should not be taken to apply to all patients with CS, such as those with HF-CS.…”

Special Issue “Coronary Artery Disease Interventions”

“…In their article about the use of extracorporeal membrane oxygenation (ECMO) in patients with AMI-associated cardiogenic shock, von Lewinski et al aimed to add realworld experience that would complement randomized-trial-derived data [17]. By applying the ECLS-Shock inclusion criteria on an all-comer cohort of cardiogenic shock (CS) patients from a large CS registry, it was proposed that mechanical circulatory support (MCS) systems might be beneficial in selected real-world cohorts [18,19].…”