11, 14
Early conservative strategy permitting downstream VA ECMO on haemodynamic worsening
Immediate VA ECMO
Small and underpowered for realistic effect sizes. Composite primary endpoint including 'implementation of another MCS', which is partly a treatment decision rather than a patient outcome. Very high control-arm crossover. Long recruitment period spanning changing practice. READ VIA SECONDARY SUMMARY (The Bottom Line) because Circulation is inaccessible from this environment; full author list, volume and pages unverified. A 1-year follow-up publication exists and has NOT been retrieved.
Severe or rapidly deteriorating cardiogenic shock, SCAI stage D or E, defined as progressive haemodynamic instability requiring repeated vasopressor boluses to maintain MAP above 50 mmHg plus impaired LV function, or multiple haemodynamic and metabolic derangements including raised lactate and reduced mixed venous saturation. Four Czech tertiary ICUs, September 2014 to January 2022. 122 randomised; ITT 58 immediate ECMO vs 59 conservative.
Composite of death from any cause, resuscitated cardiac arrest, or implementation of another mechanical circulatory support at 30 days
63.8% vs 71.2%; risk difference -7.4% (95% CI -24.3 to 9.5) - not significant. No significant difference in 30-day all-cause mortality, neurological outcome, clinically significant bleeding, leg ischaemia, pneumonia or sepsis. 23 control patients (39%) required downstream VA ECMO, of whom 52.2% died.
With 39% crossover it cannot show whether ECMO saves individual lives; it compares timing strategies, not the device against nothing. Small (122 patients), powered only to detect a 50% reduction in the composite, so a modest benefit cannot be excluded. Single-country, four centres, recruitment spanning eight years.
Immediate VA ECMO in SCAI D-E cardiogenic shock is feasible but does not improve outcomes compared with an early conservative approach that keeps ECMO available as rescue. Notably it selected on SEVERITY - the sickest end of the spectrum - and still found nothing.