High-risk PCI under support of a pulsatile left ventricular assist device – First German experience with the iVAC2L system

Abstract Background During high-risk percutaneous coronary intervention (PCI) complications may occur, leading to unstable hemodynamic conditions. Circulatory support devices might help to intercept these conditions by supporting cardiac output. We investigated in a prospective trial the performance of the pulsatile iVAC2L system in the setting of high-risk PCI. Methods Circulatory support by the iVAC2L device was attempted in 20 consecutive patients (three females, mean age 72 ± 9 years, LVEF 44 ± 12%) undergoing high-risk PCI. Aortic pressure data were collected after device placement and immediately after PCI. Results Successful device placement was achieved in 17 (85%) patients; kinking of iliac artery and device length limited correct device placement in the remaining three patients. PCI success was 100%. With ongoing support (overall support time 122 ± 32min) systolic, diastolic and mean blood pressure increased significantly and kept the higher level until device removal. Critical events occurred in three patients (massive vasospasm, coronary perforation, no-flow in LCA after wire placement), but the iVAC2L device helped to maintain stable hemodynamic conditions with no need for cardiopulmonary resuscitation. Serial controls of hemolysis related parameters in a subgroup of ten patients revealed no significant device related hemolysis after the performance of the iVAC2l system. Conclusions High-risk PCI under hemodynamic support by the iVAC2L device is feasible and safe. Aortic pressure increases with ongoing support. The device helps to stabilize hemodynamic situations if complications occur.