A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction.
OBJECTIVE
The aim of this study was to test whether the left ventricular assist device (LVAD) Impella LP2.5 (Abiomed Europe GmbH, Aachen, Germany) provides superior hemodynamic support compared with the intra-aortic balloon pump (IABP).


BACKGROUND
Cardiogenic shock caused by left ventricular failure is associated with high mortality in patients with acute myocardial infarction (AMI). An LVAD may help to bridge patients to recovery from left ventricular failure.


METHODS
In a prospective, randomized study, 26 patients with cardiogenic shock were studied. The primary end point was the change of the cardiac index (CI) from baseline to 30 min after implantation. Secondary end points included lactic acidosis, hemolysis, and mortality after 30 days.


RESULTS
In 25 patients the allocated device (n = 13 IABP, n = 12 Impella LP2.5) could be safely placed. One patient died before implantation. The CI after 30 min of support was significantly increased in patients with the Impella LP2.5 compared with patients with IABP (Impella: DeltaCI = 0.49 +/- 0.46 l/min/m(2); IABP: DeltaCI = 0.11 +/- 0.31 l/min/m(2); p = 0.02). Overall 30-day mortality was 46% in both groups.


CONCLUSIONS
In patients presenting with cardiogenic shock caused by AMI, the use of a percutaneously placed LVAD (Impella LP 2.5) is feasible and safe, and provides superior hemodynamic support compared with standard treatment using an intra-aortic balloon pump. (Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock [ISAR-SHOCK]; NCT00417378).
Seyfarth
Melchior
M
Deutsches Herzzentrum München, Technische Universität, Munich, Germany. seyfarth@dhm.mhn.de
Sibbing
Dirk
D
Bauer
Iris
I
Fröhlich
Georg
G
Bott-Flügel
Lorenz
L
Byrne
Robert
R
Dirschinger
Josef
J
Kastrati
Adnan
A
Schömig
Albert
A
D000368:Aged; D016001:Confidence Intervals; D016638:Critical Illness; D004869:Equipment Safety; D005240:Feasibility Studies; D005260:Female; D006353:Heart-Assist Devices; D006439:Hemodynamics / Q000502:physiology*; D006801:Humans; D007423:Intra-Aortic Balloon Pumping; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications* / Q000175:diagnosis; D011336:Probability; D011379:Prognosis; D011446:Prospective Studies; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D012770:Shock, Cardiogenic / Q000209:etiology / Q000401:mortality* / Q000601:surgery*; D016019:Survival Analysis; D016896:Treatment Outcome