Introduction: Percutaneous coronary intervention (PCI) has become an alternative therapy to coronary bypass surgery in complex stenosis. Several circulatory support devices have been developed to support cardiac output or maintain sufficient circulation in critical situations or complications during PCI. We compared the hemodynamic and clinical performance of a trans-femoral pulsatile assist device (iVAC2L) with the most used continuous flow assist device (Impella 2.5) in high-risk PCI.

Patients and Methods: In 30 patients [7 female, age 75±8 years, left ventricular ejection fraction (LVEF) 45±12%] high-risk PCI was performed under support with Impella 2.5 (n=13) or IVAC2L (n=17). Aortic pressure data and flow measurements were collected before and after device placement and after PCI. Blood parameters of hemolysis were collected before and after support.

Results: Correct device placement was achieved in 14 (82%) patients in the iVAC2L-group and in 12 (92%) patients in the Impella-group (p=n.s.). PCI success was 97%. Except for contrast agent (276±26ml), no additional fluids were infused. Mean support time was shorter under Impella (130±26min vs. 103±67min, p<0.05). There was no early increase in systolic, diastolic and mean aortic blood pressure under iVAC2L-support, but with prolonged support time these parameters increased significantly and kept their higher level (Tab. 1). In contrast, diastolic and mean aortic pressure increased significantly immediately under Impella-support, but with increasing support time the increase in these parameters was comparable between the two devices after PCI. Compared to the pulsatile flow under iVAC2L continuous flow under Impella was significant higher (2.05±0.08l/min vs. 1.25±0.06l/min, p<0.001). In five patients (iVAC2L n=3) critical not device-related events during PCI occurred, but both devices helped to maintain stable hemodynamic conditions with no need for cardiopulmonary resuscitation. After PCI, one severe bleeding in each group (both due to aneurysm of the femoral artery) and one stroke <24h in iVAC2L-group occurred. There was no reference of significant hemolysis in both groups (Tab.1).

Conclusion: High-risk PCI under circulatory support with either iVAC2L or Impella 2.5 is feasible and safe. Aortic pressure increases under support with both devices, but seems to increase earlier under Impella. Potential differences between the two devices with respect to patients’ outcome or hemodynamic parameters need to be evaluated in large multi-center studies.     

Table 1 (Ao = Aorta, ^*=p<0.05 prePCI _{(no support)} vs. postPCI _{(full support)}; ^#=p<0.05 prePCI _{(no support)} vs. postPCI _{(no support)}) , ^§=p<0.05 prePCI _{(full support)} vs. postPCI _{(full support)}; ^&=p <0.05 prePCI _{(no support)} vs. prePCI _{(full support)}; ^%=p<0.05 iVAC vs. Impella.