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Conventional strategy, unloading only when clinically indicated (n=30); median time from ECMO insertion to unloading 48.4 hours (IQR 47.8 to 96.5)
Early left ventricular unloading - percutaneous transseptal left atrial cannulation via the femoral vein, incorporated into the ECMO venous circuit, performed at the time of VA ECMO insertion (n=30)
Very small (60 patients), two centres, open-label, and a process endpoint (weaning) rather than a patient-centred one. High control-arm unloading rate. Read via the published abstract and a peer-reviewed review; full text not retrieved. Volume, issue, pages and full author list unverified - first author reported as Park H.
Adults receiving VA ECMO for cardiac arrest or shock at two institutions, December 2018 to August 2022. 60 patients randomised 1:1. Unloading was actually delivered in 29 (96.7%) of the early group and 23 (76.7%) of the conventional group.
Rate of successful weaning from VA ECMO
Weaning 70.0% versus 76.7%; relative risk 0.91 (95% CI 0.67 to 1.24), P=0.386. Survival to discharge 53.3% versus 50.0%, P=0.796. The pulmonary congestion score index improved significantly only in the early group (2.0 plus or minus 0.7 at baseline to 1.7 plus or minus 0.6 at 48 hours, P=0.008). Authors' conclusion: the results do not support routine application of early unloading after VA ECMO insertion.
77% of the conventional arm was eventually unloaded, so this is not a comparison against no unloading. It does not test afterload-reducing devices. With 60 patients it is powered only for very large effects.
The second randomised test of early routine left atrial venting, using the same modality as EARLY-UNLOAD and a weaning rather than mortality endpoint, and equally null. It reproduces the same dissociation: congestion clears faster, outcomes do not change. Pooled with EARLY-UNLOAD (176 patients, Eur J Heart Fail 2024, DOI 10.1002/ejhf.3178) there is no difference in in-hospital mortality, weaning or bridging, and no difference in stroke, limb ischaemia, tamponade or bleeding.