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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

Presented in part as a Late-Breaking Clinical Trial at the American College of Cardiology 2007 Annual Meeting, New Orleans, Louisiana.
https://doi.org/10.1016/j.jacc.2008.05.065Get rights and content
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Objectives

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: ΔCI = 0.49 ± 0.46 l/min/m2; IABP: ΔCI = 0.11 ± 0.31 l/min/m2; 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)

Key Words

shock
myocardial infarction
heart-assist device
hemodynamics

Abbreviations and Acronyms

AMI
acute myocardial infarction
CI
cardiac index
CPI
cardiac power index
CS
cardiogenic shock
IABP
intra-aortic balloon pump
LVAD
left ventricular assist device
MAP
mean arterial pressure
MODS
Multiple Organ Dysfunction Score
SOFA
Sepsis-related Organ Failure Assessment

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Supported by Abiomed Europe GmbH, Germany. Dr. Seyfarth received lecture fees from Abiomed.