Mechanical Circulatory Support With the CorVad 6.0 Ventricular Assist Device: Feasibility and Safety Study in an...

This study aimed to evaluate the feasibility and safety of a novel percutaneous left ventricular assist device CorVad 6.0, for mechanical circulatory support in an ovine model, focusing on device performance, hemocompatibility, and end-organ effects. The CorVad 6.0, which is a microaxial flow pump incorporating an integrated axial-flux motor, was implanted in six healthy sheep via descending aortic access. Animals were supported for 4 weeks, with pump speeds titrated to maintain flows of 1.5-5.0 L/min. All six animals survived the 4 week study period. The CorVad 6.0 was successfully implanted in all subjects with no device-related complications, demonstrating stable operation and a predictable flow response to speed changes. Key hematological and biochemical parameters, including plasma-free hemoglobin, remained within acceptable ranges throughout the study, showing no evidence of significant hemolysis or end-organ dysfunction. Macroscopic and histological analyses of the heart, liver, kidneys, and brain revealed no device-related pathological abnormalities. The CorVad 6.0 demonstrates stable hemodynamic performance and a favorable biocompatibility during a 4 week implantation period. Further study investigating chronic heart failure modes is needed.