A7 - Concept and Design of the Novel, Percutaneous, Pulsatile Left Ventricular Assist Device PERKAT-LV

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Support:The development of this supplement was funded by Abiomed.

Correspondence Details:Daniel Kretzschmar,

Open Access:

The copyright in this work belongs to Radcliffe Medical Media. Only articles clearly marked with the CC BY-NC logo are published with the Creative Commons by Attribution Licence. The CC BY-NC option was not available for Radcliffe journals before 1 January 2019. Articles marked ‘Open Access’ but not marked ‘CC BY-NC’ are made freely accessible at the time of publication but are subject to standard copyright law regarding reproduction and distribution. Permission is required for reuse of this content.

Background: Despite developments in cardiology, cardiogenic shock due to left ventricular failure still has a very high morbidity and mortality. Patients suffering from cardiogenic shock often are in need of a temporary mechanical assist device. In addition, we deal with an increasing number of patients who cannot undergo surgical myocardial revascularisation. Those patients could benefit from a protected percutaneous coronary intervention. The available left ventricular assist device systems have specific advantages and disadvantages.

Hypothesis: Our aim is to develop a novel percutaneous, pulsatile assist device that minimises system-specific disadvantages.

Methods: The PERKAT-LV (PERkutane KATheterpumptechnologie) device consists of a self-expanding nitinol pump chamber that is covered by foils. Those foils carry multiple outflow valves at the proximal part of the pump chamber. A flexible suction tube with a pigtail-shaped tip and inflow valves is attached to its distal part. The system is designed for 16 Fr percutaneous implantation via the femoral artery. Pulling back the sheath unfolds the nitinol chamber in the descending aorta while the flexible suction tube bypasses the aortic arch and ascending aorta with the pigtail tip in the left ventricle. A standard intra-aortic balloon pump (IABP) is placed into the pumping chamber and is connected to an external IABP console. Balloon deflation generates a blood flow from the left ventricle into PERKAT-LV. During balloon inflation, blood leaves the system through the outflow foil valves in the descending aorta.

Results: Preliminary in vitro studies have demonstrated the feasibility of PERKAT-LV. Depending on the size of the ballon in the IABP, flow rates of more than 2.5 l/min are possible.

Conclusion: The novel percutaneously implantable and pulsatile working PERKAT-LV device offers a circulatory support of more than 2.5 l/min in a first feasibility study. At the moment, the system is being studied in an in vitro series. After this, a first in vivo evaluation will follow. Based on the current results, we believe that the system is a promising new approach and could be used in clinical settings for patients in need of temporary left ventricular mechanical support.