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.