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Applying randomized control trial criteria to an ECPR cohort
Yigal Helviz1,2,3, Frederic Shmuel Zimmerman1, Amir Orlev2,4
1Intensive Care Unit, Shaare Zedek Medical Center, Jerusalem, Israel.
Objective:
To assess how inclusion criteria from major randomized controlled trials (RCTs) of extracorporeal cardiopulmonary resuscitation (ECPR) apply within a cannulated ECPR cohort and to benchmark observed outcomes against published trial results.
Methods:
We conducted a single-center retrospective cohort study at a 1,000-bed tertiary medical center of adults who underwent ECPR for out of hospital cardiac arrest. Inclusion criteria from the ARREST, PRAGUE, and INCEPTION trials were retrospectively applied. Analyses were restricted to cannulated patients, with survival evaluated overall and stratified by trial eligibility, and descriptively compared with published RCT outcomes.
Results:
Sixty-six patients underwent ECPR, including 25 (38%) with a non-shockable initial rhythm. Overall survival to hospital discharge was 14% (9/66; 95% CI 6.4-24.3%), with favorable neurological outcome in 5/9 survivors. Survival was numerically higher among patients meeting trial inclusion criteria, but differences were not statistically significant. Survival was comparable to PRAGUE and INCEPTION and lower than ARREST.
Conclusions:
Within this program level, cannulated ECPR cohort, RCT-derived inclusion criteria did not clearly distinguish survivors from non-survivors, and survival occurred among patients not meeting one or more trial eligibility thresholds. Rigid application of trial criteria at the point of cannulation may therefore exclude some patients with potential for meaningful recovery.
