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Updated: Apr 19, 2026
Utilizing Percutaneous Ventricular Assist Devices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Published on: June 12, 2021
First-in-man analysis of the i-cor assist device in patients with cardiogenic shock
Janine Pöss1, Steffen Kriechbaum2, Sebastian Ewen2
1Klinik für Innere Medizin II, Universitätsklinikum Schleswig-Holstein, Germany Janine.poess@uksh.de.
Insights
The novel i-cor venous-arterial extracorporeal membrane oxygenation (VA-ECMO) device shows promise for stabilizing patients with refractory cardiogenic shock (CS). This first-in-man study indicates successful application and potential for future randomized evaluations of this new VA-ECMO system.
Area of Science:
- Cardiology
- Cardiovascular Surgery
- Intensive Care Medicine
Background:
- Refractory cardiogenic shock (CS) often requires mechanical circulatory support.
- Venous-arterial extracorporeal membrane oxygenation (VA-ECMO) is a key therapy for hemodynamic stabilization in CS.
- Novel devices are continuously being developed to improve VA-ECMO therapy.
Purpose of the Study:
- To evaluate the applicability and safety of the new i-cor VA-ECMO assist device in patients with refractory CS.
- To assess the hemodynamic and clinical outcomes associated with the i-cor device.
Main Methods:
- A first-in-man study involving 15 patients with refractory CS treated with the i-cor VA-ECMO device across three centers.
- Patients presented with hypotension and elevated lactate levels, often due to acute myocardial infarction (AMI).
- Hemodynamic parameters, vasopressor use, lactate levels, renal function (GFR), and complications were monitored.
Main Results:
- Significant reductions in vasopressor therapy (norepinephrine) and serum lactate levels were observed during i-cor VA-ECMO support.
- Inspiratory oxygen concentration was significantly reduced, indicating improved oxygenation.
- Glomerular filtration rate (GFR) significantly increased, suggesting improved renal perfusion. Complications included bleeding, blood transfusion needs, limb ischemia, and hemolysis, but none required ECMO interruption. Overall mortality was 33.3%.
Conclusions:
- The i-cor VA-ECMO device demonstrated successful applicability in human patients with refractory CS.
- The device facilitated hemodynamic stabilization and improved clinical parameters.
- These findings support further evaluation and randomized trials for this novel VA-ECMO system.
Objective:
In patients with refractory cardiogenic shock (CS) mechanical assistance by venous-arterial extracorporeal membrane oxygenation (VA-ECMO) therapy may be considered to reach haemodynamic stabilization. In this first-in-man study, we analysed the applicability of the new i-cor VA-ECMO assist device equipped with a diagonal pump system.
Methods And Results:
In total, 15 patients with refractory CS were treated with the i-cor assist device in three tertiary care centres. In 71%, CS was due to acute myocardial infarction (AMI). At baseline, patients were hypotensive (systolic/diastolic blood pressure 97 ± 4/62 ± 4 mm Hg) despite high doses of catecholamines. Under ECMO therapy, a significant reduction in vasopressor therapy and serum lactate levels was observed (norepinephrine: 0.69 ± 0.1 µg/kg/min at baseline vs 0.21 ± 0.08 µg/kg/min on the last day of treatment, p<0.0001; serum lactate: 6.7 ± 1.4 mmol/l at baseline versus 1.3 ± 0.1 mmol/l on the last day, p<0.001). Inspiratory oxygen concentration was significantly reduced during the course of VA-ECMO support (80.4 ± 7.0% at baseline vs 42.7 ± 2.4% on final day; p<0.001). At baseline, three patients (20%) were on continuous haemodialysis treatment. Of the 12 patients without haemodialysis at baseline, only one patient required haemodialysis during the course of ECMO treatment. Glomerular filtration rate (GFR) significantly increased with treatment (41.2 ± 7.4 at baseline vs 69.0 ± 10.8 on last day; p=0.006). Bleeding at the insertion site was recorded in two patients (13.3%). Overall, 11 patients (73.3%) needed blood transfusion. Three patients (20%) developed signs of limb ischaemia that were fully reversible. Haemolysis was recorded in five patients (33%). None of the complications required the interruption of ECMO therapy. Overall mortality was 33.3% (five patients); two patients died during, and three patients after, ECMO therapy.
Conclusion:
This first-in-man analysis suggests that the i-cor ECMO device is successfully applicable in humans. The data set the stage for further evaluation of this novel system and provide the necessary basis to design randomised evaluations.
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