Early use of ECMO devices to support adults with cardiogenic shock did not improve clinical outcomes

Early use of ECMO devices to support adults with cardiogenic shock did not improve clinical outcomes

Immediate use of veno-arterial mechanical circulatory extracorporeal membrane oxygenation (ECMO) devices to support adults with rapidly deteriorating or severe cardiogenic shock was feasible but did not improve clinical outcomes compared to people who received early conservative therapy, according to a recent clinical trial. The results were presented today at the American Heart Association's 2022 Scientific Sessions. The meeting, held in person and virtually November 5-7, 2022 in Chicago, is a premier global exchange of the latest scientific advances, research findings and evidence-based clinical practice updates in cardiovascular science.

Cardiogenic shock occurs when the heart cannot pump enough blood and oxygen to the brain and other vital organs. Treatment of patients with cardiogenic shock includes administration of medications such as inotropes and vasopressors. Inotropes alter the force of the heart's contractions, and vasopressors constrict blood vessels to increase blood pressure. ECMO life support machines can also be used to support blood circulation by pumping a patient's blood out of the body and oxygenating it, allowing the heart and lungs to rest.

ECMO is a widely used, minimally invasive, short-term mechanical circulatory support device that allows rapid restoration of circulation and blood flow to organs. ECMO is increasingly being used for circulatory support in people in cardiogenic shock or cardiac arrest, but current evidence on the use of ECMO to stabilize hemodynamic conditions in these patients remains inadequate.”

Petr Ostadal, MD, Ph.D., Professor of Medicine in the Department of Cardiology at Na Homolce Hospital in the Czech Republic

The ECMO-CS trial is the first multicenter, randomized clinical trial focused on the use of ECMO in people with severe or rapidly progressive cardiogenic shock. The study involved 117 adults with an average age of 65 years, and approximately 75% of patients were male adults. Participants were randomized into two groups: the ECMO group or the early conservative therapy group, and their baseline clinical parameters were comparable at randomization: they had similar lactate levels and similar mean arterial pressure.

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In the conservative therapy group, ECMO may have been used later if the hemodynamic status worsened. All other diagnostic and therapeutic procedures were performed according to current standards of care, including treatment with other cardiovascular interventions or mechanical circulatory support devices when necessary.

The results showed that the clinical outcomes of patients who received early conservative therapy with inotropes and vasopressors were similar to those in the immediate ECMO group:

• Innerhalb von 30 Tagen nach einem schweren oder schnell fortschreitenden kardiogenen Schock starben 64 % der Patienten, die eine frühe ECMO-Therapie erhielten, eine Herzwiederbelebung benötigten oder zusätzliche mechanische Kreislaufunterstützung benötigten, verglichen mit 71 % der Patienten, die eine frühe konservative Behandlung erhielten.
• Die Sterblichkeitsraten nach 30 Tagen waren zwischen beiden Gruppen vergleichbar (50 % vs. 48 %).
• Schwerwiegende Nebenwirkungen wie Blutungen, Beinischämie, Schlaganfall, Lungenentzündung und Sepsis traten bei 60 % der Patienten in der ECMO-Gruppe und bei 61 % der Patienten in der frühkonservativen Gruppe auf.
• Weniger Patienten in der ECMO-Gruppe benötigten eine andere Form der mechanischen Kreislaufunterstützung im Vergleich zu denen in der frühkonservativen Gruppe (jeweils 17 % vs. 42 %).
• 39 % der Patienten, die eine frühe konservative Therapie erhielten, benötigten später im Verlauf der Intensivbehandlung eine ECMO-Unterstützung.

“We expected a significant improvement in outcomes in patients with severe or rapidly progressive cardiogenic shock who underwent early ECMO treatment, and we were surprised to find that immediate use of ECMO was actually not superior to early conservative therapy,” Ostadal said.

Limitations of the study included that the study did not compare ECMO implementation with conservative therapy, but rather compared an early ECMO strategy with an early conservative strategy that allowed for “bailout” ECMO therapy in cases of deteriorating hemodynamic status. Furthermore, the study was not blinded and had a limited sample size. Exclusion criteria also included multiple conditions that can cause or influence cardiogenic shock (e.g., cardiac tamponade, pulmonary embolism, cardiac arrest survivor).

Source:

American Heart Association

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