Early left ventricular unloading after venoarterial extracorporeal membrane oxygenation: 1-year outcomes of the EARLY-UNLOAD randomized clinical trial.

Aims: The long-term effects of early left ventricular (LV) unloading after venoarterial extracorporeal membrane oxygenation (VA-ECMO) remain unclear.

Methods And Results: The EARLY-UNLOAD trial was a single-centre, investigator-initiated, open-label, randomized clinical trial involving 116 patients with cardiogenic shock (CS) undergoing VA-ECMO. The patients were randomly assigned to undergo either early routine LV unloading by transseptal left atrial cannulation within 12 h after randomization or the conventional approach, which permitted rescue transseptal cannulation in case of an increased LV afterload. The pre-specified secondary endpoints at 1 year included all-cause mortality, cardiac mortality, non-cardiac mortality, rehospitalization for heart failure (HF), and the composite of all-cause mortality or rehospitalization for HF. At 1 year, data for 114 of 116 patients (98.3%) were available for analysis. All-cause death had occurred in 33 of 58 patients (56.9%) in early group and 32 of 56 patients (57.1%) in conventional group {hazard ratio [HR], 0.97 [95% confidence interval (CI), 0.60 to 1.58], P = 0.887}. There was no significant difference in cardiac or non-cardiac mortality. Among 61 survivors at 30 days, the incidence of rehospitalization for HF at 1 year was comparable between two groups [HR, 1.17 (95% CI 0.43 to 3.24), P = 0.758]. The incidence of the composite outcome of all-cause mortality or rehospitalization for HF also did not differ between the groups [HR, 1.01 (95% CI 0.69 to 1.76), P = 0.692].

Conclusion: Among patients with CS undergoing VA-ECMO, early routine LV unloading did not improve clinical outcomes at 1 year of follow-up.

Registration: ClinicalTrials.gov: NCT04775472.