Applying randomized control trial criteria to an ECPR cohort.

Area of Science:

• Cardiovascular Medicine
• Critical Care Medicine
• Emergency Medicine

Background:

• Major randomized controlled trials (RCTs) for extracorporeal cardiopulmonary resuscitation (ECPR) establish inclusion criteria.
• The applicability of these criteria to real-world ECPR patient cohorts is not well-defined.

Purpose of the Study:

• To evaluate how inclusion criteria from key ECPR RCTs (ARREST, PRAGUE, INCEPTION) apply to a cannulated ECPR patient cohort.
• To compare observed survival outcomes in this cohort against published RCT results.

Main Methods:

• A single-center retrospective cohort study of adults undergoing ECPR for out-of-hospital cardiac arrest.
• Retrospective application of inclusion criteria from ARREST, PRAGUE, and INCEPTION trials.
• Analysis of survival to hospital discharge, stratified by trial eligibility, and comparison with published RCT data.

Main Results:

• Overall survival to discharge was 14% (9/66), with favorable neurological outcomes in 5 survivors.
• Survival was numerically higher in patients meeting trial criteria, but without statistical significance.
• Survival rates were comparable to the PRAGUE and INCEPTION trials and lower than the ARREST trial.

Conclusions:

• RCT-derived inclusion criteria did not clearly differentiate survivors from non-survivors in this cannulated ECPR cohort.
• Survival was observed in patients who did not meet all trial eligibility thresholds.
• Rigid application of trial criteria at cannulation may exclude patients with potential for recovery.