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

TLDR

Mortality in cardiogenic shock after acute myocardial infarction remains unacceptably high despite percutaneous coronary intervention and intra‑aortic balloon pump support. This study tests whether a newly developed percutaneous left‑ventricular assist device can provide superior haemodynamic support and reduce mortality. Forty‑one patients with cardiogenic shock after AMI were randomized to receive either an intra‑aortic balloon pump (n = 20) or the TandemHeart VAD (n = 21) during planned PCI. The VAD increased cardiac power index from 0.22 to 0.37 W/m² versus 0.22 to 0.28 W/m² with the balloon pump, yet it was associated with higher rates of severe bleeding and limb ischemia, while 30‑day mortality was comparable (45 % vs 43 %).

Abstract

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 Heart™, 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.