Comparison of a pulsatile and a continuous flow left ventricular assist device in high-risk PCI

Background: Mechanical circulatory support devices are able to generate additional cardiac output or maintain sufficient circulation during high-risk PCI. We prospectively compared the hemodynamic and clinical performance of the new iVAC2L® device with the Impella 2.5® device during high-risk PCI.

Materials and methods: In 40 patients [10 female, age 75 ± 8 years, left ventricular ejection fraction (LVEF) 44 ± 11%] high-risk PCIs were performed under iVAC (n = 20) or Impella (n = 20) support. Hemodynamic parameters were collected before and after device placement as well as immediately after PCI. Blood parameters of hemolysis were analyzed before and after support.

Results: Correct device placement was achieved in 17 patients (85%) under iVAC use and in 19 patients (95%) under Impella use. PCI success was 98%. Under iVAC2L® support, systolic, diastolic and mean aortic blood pressure increased significantly with increasing support time. In contrast, aortic pressure increased directly under Impella support, but the increase was comparable between both devices. Impella support generated a significantly higher additional blood flow, as compared to iVAC support (2.07 ± 0.09 l/min vs. 1.25 ± 0.05 l/min, p < 0.001). Five patients (iVAC n = 3) suffered from critical events during high-risk PCI, but both devices were able to maintain stable hemodynamic conditions. After PCI, one severe bleeding occurred in each group. After Impella support, haptoglobin was significantly decreased, indicating potential hemolysis.

Conclusions: High-risk PCIs under support by both devices are feasible and safe and ensure stable hemodynamic conditions also if complications occur. Aortic pressure increases significantly with both devices, but later under iVAC use. Potential hemolysis occurs more frequent under Impella support.