title: Percutaneous left-ventricular support with the Impella-2.5-assist device in acute cardiogenic shock: results of the Impella-EUROSHOCK-registry.
abstract: BACKGROUND
  Acute cardiogenic shock after myocardial infarction is associated with high in-hospital mortality attributable to persisting low-cardiac output. The Impella-EUROSHOCK-registry evaluates the safety and efficacy of the Impella-2.5-percutaneous left-ventricular assist device in patients with cardiogenic shock after acute myocardial infarction.
  
  
  RESULTS
  This multicenter registry retrospectively included 120 patients (63.6±12.2 years; 81.7% male) with cardiogenic shock from acute myocardial infarction receiving temporary circulatory support with the Impella-2.5-percutaneous left-ventricular assist device. The primary end point evaluated mortality at 30 days. The secondary end point analyzed the change of plasma lactate after the institution of hemodynamic support, and the rate of early major adverse cardiac and cerebrovascular events as well as long-term survival. Thirty-day mortality was 64.2% in the study population. After Impella-2.5-percutaneous left-ventricular assist device implantation, lactate levels decreased from 5.8±5.0 mmol/L to 4.7±5.4 mmol/L (P=0.28) and 2.5±2.6 mmol/L (P=0.023) at 24 and 48 hours, respectively. Early major adverse cardiac and cerebrovascular events were reported in 18 (15%) patients. Major bleeding at the vascular access site, hemolysis, and pericardial tamponade occurred in 34 (28.6%), 9 (7.5%), and 2 (1.7%) patients, respectively. The parameters of age >65 and lactate level >3.8 mmol/L at admission were identified as predictors of 30-day mortality. After 317±526 days of follow-up, survival was 28.3%.
  
  
  CONCLUSIONS
  In patients with acute cardiogenic shock from acute myocardial infarction, Impella 2.5-treatment is feasible and results in a reduction of lactate levels, suggesting improved organ perfusion. However, 30-day mortality remains high in these patients. This likely reflects the last-resort character of Impella-2.5-application in selected patients with a poor hemodynamic profile and a greater imminent risk of death. Carefully conducted randomized controlled trials are necessary to evaluate the efficacy of Impella-2.5-support in this high-risk patient group.
authors.affiliation: Department of Internal Medicine I., Friedrich-Schiller University, Erlanger Allee, Jena, Germany. alexander.lauten@med.uni-jena.de
authors.forename: Alexander
authors.initials: A
authors.lastname: Lauten
authors.forename: Annemarie E
authors.initials: AE
authors.lastname: Engström
authors.forename: Christian
authors.initials: C
authors.lastname: Jung
authors.forename: Klaus
authors.initials: K
authors.lastname: Empen
authors.forename: Paul
authors.initials: P
authors.lastname: Erne
authors.forename: Stéphane
authors.initials: S
authors.lastname: Cook
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Martin W
authors.initials: MW
authors.lastname: Bergmann
authors.forename: Roland
authors.initials: R
authors.lastname: Klingenberg
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Lüscher
authors.forename: Michael
authors.initials: M
authors.lastname: Haude
authors.forename: Dierk
authors.initials: D
authors.lastname: Rulands
authors.forename: Christian
authors.initials: C
authors.lastname: Butter
authors.forename: Bengt
authors.initials: B
authors.lastname: Ullman
authors.forename: Laila
authors.initials: L
authors.lastname: Hellgren
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Modena
authors.forename: Giovanni
authors.initials: G
authors.lastname: Pedrazzini
authors.forename: Jose P S
authors.initials: JP
authors.lastname: Henriques
authors.forename: Hans R
authors.initials: HR
authors.lastname: Figulla
authors.forename: Markus
authors.initials: M
authors.lastname: Ferrari
mesh_terms: D000208:Acute Disease; D004867:Equipment Design; D005060:Europe / Q000453:epidemiology; D005260:Female; D006352:Heart Ventricles / Q000503:physiopathology* / Q000601:surgery; D006353:Heart-Assist Devices; D006439:Hemodynamics; D017052:Hospital Mortality / Q000639:trends; D006801:Humans; D008297:Male; D008875:Middle Aged; D012042:Registries; D012189:Retrospective Studies; D012770:Shock, Cardiogenic / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome