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.

Effectiveness and Safety of a Prolonged Hemodynamic Support by the IVAC2L System in Healthy and Cardiogenic Shock Pigs.

BACKGROUND: Mechanical circulatory supports are used in case of cardiogenic shock (CS) refractory to conventional therapy. Several devices can be employed, but are limited by their availability, benefit risk-ratio, and/or cost. AIMS: To investigate the feasibility, safety, and effectiveness of a long-term support by a new available device (IVAC2L) in pigs. METHODS: Experiments were carried out in male pigs, divided into healthy (n = 6) or ischemic CS (n = 4) groups for a median support time of 34 and 12 h, respectively. IVAC2L was implanted under fluoroscopic and TTE guidance under general anesthesia. CS was induced by surgical ligation of the left anterior descending artery. An ipsilateral lower limb reperfusion was created with the Solopath® system. Reperfusion was started after 1 h of support in healthy pigs and upon IVAC2L insertion in CS pigs. Hemodynamic and biological parameters were monitored before and during the whole period of support in each group. RESULTS: Occurrence of an ipsilateral lower limb ischemia was systematic in healthy and CS pigs in a few minutes after IVAC2L implantation, and could be reversed by the arterial reperfusion, as demonstrated by distal transcutaneous pressure in oxygen (TcPO2) and lactate normalization. IVAC2L support decreased pulmonary capillary wedge pressure (PCWP) (15.3 ± 0.3 vs. 7.5 ± 0.9 mmHg, p < 0.001), increased systolic blood pressure (SBP) (70 ± 4.5 vs. 101.3 ± 3.1 mmHg, p < 0.01), and cardiac output (CO) (4.0 ± 0.3 vs. 5.2 ± 0.6 l/min, p < 0.05) in CS pigs; at CS onset and after 12 h of support, without effects on heart rate or pulmonary artery pressure (PAP). Non-sustained ventricular arrhythmias were frequent at implantation (50%). A non-significant hemolysis was observed under support in CS pigs. Bleedings were frequent at the insertion and/or operating sites (30%). CONCLUSION: Long-term support by IVAC2L is feasible and associated with a significant hemodynamic improvement in a porcine model. These preclinical data open the door for a study of IVAC2L in human ischemic CS, keeping in mind the need for systematic reperfusion of the lower limb and the associated risk of bleeding.

PulseCath iVAC2L: next-generation pulsatile mechanical circulatory support.

Contemporary state of the art percutaneous coronary intervention techniques offer treatment strategies and solutions to an increasing number of patients with heart failure and complex coronary artery disease. Percutaneous mechanical circulatory support is intended to alleviate the mechanical and energetic workload imposed to a failing ventricle by reducing left ventricle pressures and volumes and potentially also increasing coronary blood flow. The PulseCath iVAC2L is a transaortic left ventricular assist device that applies a pneumatic driving system to produce pulsatile forward flow. Herein, the essential aspects regarding iVAC2L are discussed with focus on its mechanisms of action and the available clinical experience.

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

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 ±â€¯9 years, LVEF 44 ±â€¯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 ±â€¯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.