Early ECMO does not improve outcomes vs. conservative strategy in cardiogenic shock
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CHICAGO — Early veno-arterial extracorporeal membrane oxygenation for cardiogenic shock did not improve outcomes vs. a conservative strategy allowing for downstream extracorporeal membrane oxygenation in case of further hemodynamic decline, a speaker reported.
However, immediate veno-arterial extracorporeal membrane oxygenation (ECMO) did reduce the odds of requiring another mechanical circulatory support within 30 days due to further deterioration of hemodynamic status compared with the conservative strategy for rapidly deteriorating or severe cardiogenic shock, according to data presented at the American Heart Association Scientific Sessions.
Photo credit: Scott Buzby, Online Managing Editor
“Immediate implementation of ECMO in patients with rapidly deteriorating or severe cardiogenic shock did not improve clinical outcomes compared with an early conservative strategy that permitted downstream use of ECMO in case of further hemodynamic worsening,” Petr Ostadal, MD, PhD, professor of medicine in the department of cardiology at Na Homolce Hospital in Prague, said during a press conference.
ECMO-CS was a multicenter, investigator-initiated, randomized trial that enrolled 117 patients at four centers in the Czech Republic with rapidly deteriorating or severe cardiogenic shock to compare immediate implementation of veno-arterial ECMO compared with an initial conservative therapy allowing for downstream ECMO in case of worsening hemodynamic status.
The primary endpoint was a composite of all-cause mortality, resuscitated circulatory arrest and implementation of another mechanical circulatory support device at 30 days.
Rapidly deteriorating cardiogenic shock was defined as Society for Cardiovascular Angiography and Interventions (SCAI) stage D to E and severe cardiogenic shock was defined as SCAI stage D.
Researchers reported no significant difference between an immediate veno-arterial ECMO compared with a conservative strategy for the primary composite endpoint, with a cumulative incidence of 63.8% in the early ECMO group and 71.2% in the conservative therapy group at 30 days (HR = 0.72; 95% CI, 0.46-1.12; P = .21).
However, 39% of patients who received the initial conservative strategy ended up requiring downstream ECMO.
Patients who received immediate veno-arterial ECMO were less likely to require another mechanical circulatory support device within 30 days compared with the conservative strategy (17.2% vs. 42.4%; HR = 0.38; 95% CI, 0.18-0.79). There were no differences between the groups in death or resuscitated cardiac arrest at 30 days.
Moreover, there was no significant difference between early ECMO and the conservative strategy for any of the safety endpoints, including a composite of serious adverse events that included bleeding, leg ischemia, stroke, pneumonia and sepsis.
“A substantial proportion of patients with early conservative strategy required downstream use of ECMO or other mechanical circulatory support due to further deterioration of hemodynamic status,” Ostadal said during a presentation. “Therefore, even in patients with severe or rapidly degenerating cardiogenic shock, early hemodynamic stabilization using inotropes and vasopressors with implementation of mechanical circulatory support only in case of further hemodynamic worsening is a therapeutic strategy comparable to the immediate insertion of ECMO.”
References:
- Early use of ECMO devices did not improve outcomes in people with cardiogenic shock. newsroom.heart.org/news/early-use-of-ecmo-devices-did-not-improve-outcomes-in-people-with-cardiogenic-shock. Accessed Nov. 6, 2022. Published Nov. 6, 2022.
- Ostadal P, et al. Circulation. 2022;doi:10.1161/CIRCULATIONAHA.122.062949.
Perspective
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ECMO-CS was an impressive trial done over 6 to 7 years in the Czech Republic. It’s very hard to recruit these patients with cardiogenic shock and then randomly assign them to ECMO compared with usual care with inotropic and vasopressor agents. They only had 60 patients in the conservatively managed group vs. around 60 in ECMO-treated group.
They showed no difference in outcomes in ECMO-CS, suggesting the futility of ECMO, at least by this study.
However, this study generates lots of questions. It was conducted over a long period, and there have been advances in ECMO and mechanical support since 2014 when the study was started. It was noted that in the 60 patients in the conservatively treated group about 40% were converted over to receive ECMO down the road. The author suggested that this finding shows a conservative strategy may be a better way to treat these patients; to wait and see if they need ECMO and let me convert over mechanical support.
There were other questions raised about afterload — ECMO increases afterload — and whether or not unloading with adjunctive mechanical support, perhaps with Impella (Abiomed), which is also being used in many centers along with ECMO, the so-called Ecpella, and whether that might be another way this could be compared vs. conservative management as well.
ECMO-CS was a great, hard-to-do study. The researchers are congratulated for pulling this off in this very high-risk patient group. It does beget more questions that are helpful because it gives us direction about where we should go in the future as we compare these mechanical support devices with each other and with conservative best medical therapy.
Perspective
Back to TopECMO-CS was resoundingly negative. Early deployment of ECMO compared with ongoing management with IV inotropes and vasopressors did not seem to fundamentally change what happened to these patients.
In the study as well as in the large ECMO registries, death rates are 50% to 60% and that’s what was seen here.
The study does not say that ECMO is not appropriate or that ECMO can’t be helpful. What it does say is that deploying it early probably doesn’t make a big difference when the patient is quasi-stable on IV therapies. This is a high-risk population. We are not curing many of these patients through stabilization with ECMO.
Medical Director, Advanced Heart Failure
University of Colorado School of Medicine
Anschutz Medical Campus
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Ostadal P, et al. LBS.03: High Impact Trials in Intervention and Surgery. Presented at: American Heart Association Scientific Sessions; Nov. 5-7, 2022; Chicago (hybrid meeting).
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