Author + information
- Suzanne de Waha1,
- Alexander Jobs1,
- Dagmar Ouweneel2,
- Jose PS. Henriques3,
- Melchior Seyfarth4,
- Steffen Desch5,
- Ingo Eitel6,
- Janine Pöss1,
- Georg Fuernau1 and
- Holger Thiele7
- 1University Heart Center Luebeck, Luebeck, Germany
- 2Academic Medical Center - University of Amsterdam, Amsterdam, Netherlands
- 3Academic Medical Center - University of Amsterdam, Amsterdam, Netherlands
- 4University of Witten/Herdecke, Wuppertal, Germany
- 5University Heart Center Leipzig, Leipzig, Germany
- 6University Heart Center Lübeck, Lübeck, Germany
- 7Heart Center Leipzig - University of Leipzig, Leipzig, Germany
The impact on clinical outcome of active mechanical circulatory support (MCS) devices in cardiogenic shock (CS) has not been fully elucidated yet. This collaborative meta-analysis of randomized trials thus aimed to investigate the efficacy and safety of percutaneous active MCS versus control in CS.
Randomized trials comparing percutaneous active MCS to control in patients with CS predominantly complicated by acute myocardial infarction (AMI) were identified through searches of medical literature databases. Risk ratios (RR) and 95% confidence intervals (95%CI) were calculated to analyze the primary endpoint of 30-day mortality as well as device-related complications including bleeding and leg ischemia. Mean differences (MD) were calculated for cardiac index (CI), mean arterial pressure (MAP), pulmonary capillary wedge pressure (PCWP), and arterial lactate.
Four trials randomizing 148 patients to either TandemHeart™ or Impella® MCS (n=77) versus control (n=71) were identified. In all four trials intraaortic balloon pumping (IABP) served as control. There was no difference in 30-day mortality (RR 1.01, 95%CI 0.70 to 1.44, p=0.98, I2 0%) for active MCS compared to control. Active MCS significantly increased MAP (MD 11.85 mmHg, 95%CI 3.39 to 20.31, p=0.02, I2 32.7%) and decreased arterial lactate (MD -1.36 mmol/l, 95%CI -2.52 to -0.19, I2 0%, p=0.02) at comparable CI (MD 0.32, 95%CI -0.24 to 0.87, p=0.14, I2 44.1%), and PCWP (MD -5.59, 95% -15.59 to 4.40, p=0.14, I2 81.1%). No significant difference was observed with respect to the incidence of leg ischemia (RR 2.64, 95%CI 0.83 to 8.39, p=0.10, I2 0%), whereas the rate of bleeding was significantly increased in MCS compared to IABP (RR 2.50, 95%CI 1.55 to 4.04, p<0.001, I2 0%).
Despite initial beneficial effects on MAP and arterial lactate, active percutaneous MCS did not improve mortality in comparison to control in patients with CS, which may be partly explained by an excess of complications such as bleeding. Results of this collaborative meta-analysis do not support the unselected use of active MCS patients with CS complicating AMI.
CORONARY: Hemodynamic Support and Cardiogenic Shock