Concept and Design of a Novel Pulsatile Left Heart Assist Device-The PERKAT Left Ventricle System.

Cardiogenic shock is associated with high mortality. Patients often require temporary mechanical circulatory support. We aimed to develop a percutaneously implantable, assist device that unloads the left ventricle (LV) in a pulsatile way. The PERkutane KATheter pump technologie (PERKAT LV) device consists of a nitinol pump chamber, which is covered by foils carrying outflow valves. A flexible tube with a pigtail-shaped tip and inflow holes represents the distal part of the pump. The system is designed for 16F percutaneous implantation. The nitinol chamber is placed in the descending aorta while the flexible tube bypasses aortic arch and ascending aorta with its tip in the LV. An intra-aortic balloon pump is placed into the chamber and connected to a console. Balloon deflation generates a blood flow from the LV into the pump chamber. During balloon inflation, blood leaves the system through the outflow foil valves in the descending aorta. Under different afterload settings using a 30 cc intra-aortic balloon pump and varying inflation/deflations rates, we recorded flow rates up to 3.0 L/min. Based on this, we believe that PERKAT LV is a promising approach for temporary LV support. The proposed design and its excellent performance give basis for in vivo tests in an animal model.