- ECMO has been used as a salvage strategy in severe cardiogenic shock. However, it is unclear whether immediate ECMO initiation is superior to an initial trial of medical therapy with subsequent MCS utilization as needed if no improvement occurs.
- In the ECMO-CS study, patients presenting with severe cardiogenic shock (SCAI stage D-E) were randomized to either immediate ECMO or medical therapy (with downstream MCS as needed) The primary outcome of interest was a 30-day composite of death from any cause, resuscitated circulatory arrest, and implementation of any other MCS device.
- Immediate ECMO initiation was not associated with a significant reduction in the primary outcome relative to medical therapy with downstream as-needed MCS. There was a 40% crossover in the conservative arm to eventual downstream ECMO.
There has been an upsurge of trials examining the use of various mechanical support devices in severe cardiogenic shock. While ECMO has been examined in cardiogenic shock, there has yet to be a large RCT examining immediate ECMO implantation in severe shock compared to first-line medical therapy with subsequent MCS use as-needed. In a breaking presentation at the 2022 AHA Scientific Sessions today, Dr. Petr Ostadal (Na Homolce Hospital, Prague) and his team presented their study: “ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock,” or the ECMO-CS trial.
The ECMO-CS study (NCT02301819) was a multi-center randomized clinical trial conducted across 4 hospitals in the Czech Republic which evaluated the effects of immediate ECMO implantation or early conservative therapy with downstream MCS as needed in patients presenting with rapidly deteriorating (SCAI D-E) cardiogenic shock. The inclusion criteria comprised any adults presenting with rapidly deteriorating cardiogenic shock ,SCAI stage D-E, (ie, requiring repeated bolus vasopressors to maintain MAP >50). A total of 122 patients were randomized. The mean age was 66, and 47% of patients were female. At the time of randomization, the mean lactate was 5 mmol/L, >70% of patients were mechanically ventilated, and the median vasoactive-inotropic score was 60. The cause of cardiogenic shock was STEMI in half of the patients, and decompensation of CHF in 23%. In the conservative treatment arm, 39% of patients eventually did receive ECMO after randomization due to worsening clinical status.
The primary outcome was a 30-day composite of death from any cause, resuscitated circulatory arrest, and implementation of any other MCS device, which was not statistically different between the two groups. Secondary outcomes included each of the individual components of the composite, which were all non-significant as well. There were also no differences in safety endpoints, including bleeding, leg ischemia, and sepsis.
When discussing the clinical implications of the study at AHA, Dr. Ostadal stated: “Even in patients with severe or rapidly deteriorating cardiogenic shock (SCAI stage D-E), early hemodynamic stabilization using inotropes and vasopressors with implementation of MCS only in case of further hemodynamic worsening is a therapeutic strategy comparable to the immediate insertion of ECMO.”