Document Detail


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.
MedLine Citation:
PMID:  19007597     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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: 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).
Authors:
Melchior Seyfarth; Dirk Sibbing; Iris Bauer; Georg Fröhlich; Lorenz Bott-Flügel; Robert Byrne; Josef Dirschinger; Adnan Kastrati; Albert Schömig
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  52     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2008 Nov 
Date Detail:
Created Date:  2008-11-14     Completed Date:  2008-12-10     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1584-8     Citation Subset:  AIM; IM    
Affiliation:
Deutsches Herzzentrum München, Technische Universität, Munich, Germany. seyfarth@dhm.mhn.de
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MeSH Terms
Descriptor/Qualifier:
Aged
Confidence Intervals
Critical Illness
Equipment Safety
Feasibility Studies
Female
Heart-Assist Devices*
Hemodynamics / physiology*
Humans
Intra-Aortic Balloon Pumping*
Male
Middle Aged
Myocardial Infarction / complications*,  diagnosis
Probability
Prognosis
Prospective Studies
Risk Assessment
Sensitivity and Specificity
Shock, Cardiogenic / etiology,  mortality*,  surgery*
Survival Analysis
Treatment Outcome

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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