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European Heart Journal Advance Access originally published online on February 25, 2005
European Heart Journal 2005 26(13):1276-1283; doi:10.1093/eurheartj/ehi161
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© The European Society of Cardiology 2005. All rights reserved. For Permissions, please e-mail: journals.permissions@oupjournals.org

Randomized comparison of intra-aortic balloon support with a percutaneous left ventricular assist device in patients with revascularized acute myocardial infarction complicated by cardiogenic shock

Holger Thiele*, Peter Sick, Enno Boudriot, Klaus-Werner Diederich, Rainer Hambrecht, Josef Niebauer and Gerhard Schuler

Department of Internal Medicine/Cardiology, University of Leipzig-Heart Centre, Strümpellstr. 39, 04289 Leipzig, Germany

Received 22 July 2004; revised 25 November 2004; accepted 6 January 2005; online publish-ahead-of-print 25 February 2005.

* Corresponding author. Tel: +49 341 865 1428; fax: +49 341 865 1461. E-mail address: thielh{at}medizin.uni-leipzig.de

Aims Mortality in cardiogenic shock (CS) following acute myocardial infarction (AMI) remains unacceptably high despite percutaneous coronary intervention (PCI) of the infarcted artery and use of intra-aortic balloon pump (IABP) counterpulsation. A newly developed percutaneous left ventricular assist device (VAD) (Tandem HeartTM, Cardiac Assist, Pittsburgh, PA, USA) with active circulatory support might have positive haemodynamic effects and decrease mortality.

Methods and results Patients in CS after AMI, with intended PCI of the infarcted artery, were randomized to either IABP (n=20) or percutaneous VAD support (n=21). The primary outcome measure cardiac power index, as well as other haemodynamic and metabolic variables, could be improved more effectively by VAD support from 0.22 [interquartile range (IQR) 0.19–0.30] to 0.37 W/m2 (IQR 0.30–0.47, P<0.001) when compared with IABP from 0.22 (IQR 0.18–0.30) to 0.28 W/m2 (IQR 0.24–0.36, P=0.02; P=0.004 for intergroup comparison). However, complications like severe bleeding (n=19 vs. n=8, P=0.002) or limb ischaemia (n=7 vs. n=0, P=0.009) were encountered more frequently after VAD support, whereas 30 day mortality was similar (IABP 45% vs. VAD 43%, log-rank, P=0.86).

Conclusion Haemodynamic and metabolic parameters can be reversed more effectively by VAD than by standard treatment with IABP. However, more complications were encountered by the highly invasive procedure and by the extracorporeal support.

Key Words: Shock • Heart-assist device • Extracorporeal circulation • Myocardial infarction


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