title: First-in-man analysis of the i-cor assist device in patients with cardiogenic shock.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Klinik für Innere Medizin II, Universitätsklinikum Schleswig-Holstein, Germany Janine.poess@uksh.de.
authors.forename: Janine
authors.initials: J
authors.lastname: Pöss
authors.affiliation: Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Kriechbaum
authors.affiliation: Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Ewen
authors.affiliation: SLK Kliniken Heilbronn GmbH, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Graf
authors.affiliation: SLK Kliniken Heilbronn GmbH, Germany.
authors.forename: Isabell
authors.initials: I
authors.lastname: Häger
authors.affiliation: SLK Kliniken Heilbronn GmbH, Germany.
authors.forename: Marcus
authors.initials: M
authors.lastname: Hennersdorf
authors.affiliation: Universitätsklinikum Leipzig AöR, Germany.
authors.forename: Sirak
authors.initials: S
authors.lastname: Petros
authors.affiliation: Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Link
authors.affiliation: Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Böhm
authors.affiliation: Klinik für Innere Medizin II, Universitätsklinikum Schleswig-Holstein, Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Thiele
authors.affiliation: Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Laufs
mesh_terms: D001803:Blood Transfusion / Q000379:methods; D002395:Catecholamines / Q000378:metabolism; D015199:Extracorporeal Membrane Oxygenation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D005260:Female; D005858:Germany / Q000453:epidemiology; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006439:Hemodynamics / Q000187:drug effects / Q000502:physiology; D006801:Humans; D007677:Kidney Function Tests; D019344:Lactic Acid / Q000097:blood; D008297:Male; D008875:Middle Aged; D009026:Mortality; D009203:Myocardial Infarction / Q000473:pathology; D012189:Retrospective Studies; D012770:Shock, Cardiogenic / Q000473:pathology / Q000628:therapy*; D062606:Tertiary Care Centers
chemical_list: D002395:Catecholamines; D019344:Lactic Acid
keywords: Cardiogenic shock; extracorporeal membrane oxygenation