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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

Melchior Seyfarth, MD^_*,,_*, Dirk Sibbing, MD^_*, Iris Bauer, MS^_*, Georg Fröhlich, MD, Lorenz Bott-Flügel, MD, Robert Byrne, MB, MRCPI^_*, Josef Dirschinger, MD, Adnan Kastrati, MD^_* and Albert Schömig, MD^_*,

^_* Deutsches Herzzentrum München, Technische Universität, Munich, Germany
1. Medizinische Klinik rechts der Isar, Technische Universität, Munich, Germany

Manuscript received January 15, 2008; revised manuscript received April 22, 2008, accepted May 27, 2008.

^_* Reprint requests and correspondence: Dr. Melchior Seyfarth, Deutsches Herzzentrum München, Lazarettstrasse 36, 80636 Munich, Germany (Email: seyfarth{at}dhm.mhn.de).

Presented in part as a Late-Breaking Clinical Trial at the American College of Cardiology 2007 Annual Meeting, New Orleans, Louisiana.

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: CI = 0.49 ± 0.46 l/min/m²; IABP: CI = 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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