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Hemodynamic Performance of a Novel Right Ventricular Assist Device (PERKAT)

Kretzschmar, Daniel; Schulze, P. Christian; Ferrari, Markus W.

doi: 10.1097/MAT.0000000000000464
Adult Circulatory Support

Acute right ventricular failure (RVF) is an increasing clinical problem and a life-threatening condition. Right ventricular assist devices represent a reasonable treatment option for patients with refractory RVF. We here present a novel percutaneously implantable device for right ventricular support. The PERKAT device is based on a nitinol stent cage, which is covered with valve-carrying foils. A flexible outlet trunk with a pigtail tip is connected to the distal part. The device is driven by an intra-aortic balloon pump (IABP) drive unit, which inflates/deflates a standard IABP-balloon placed within the stent cage. In-vitro evaluation was done in a liquid bath containing water or blood analog. The PERKAT device was tested in different afterload settings using two different IABP-balloons and varying inflation/deflation rates. We detected flow rates ranging from 1.97 to 3.93 L/min depending on the afterload setting, inflation/deflation rate, balloon size, and the medium used. Flow rates between water and blood analog were nearly comparable, and in the higher inflation/deflation rate settings slightly higher with water. Based on this promising in vitro data, the innovative percutaneously implantable PERKAT device has a potential to become a therapeutic option for patients with RVF refractory to medical treatment.

From the *Department of Internal Medicine I, Division of Cardiology, Friedrich-Schiller-University Jena, Jena, Germany; and HSK, Clinic of Internal Medicine I, Helios-Kliniken, Wiesbaden, Germany.

Submitted for consideration April 2016; accepted for publication in revised form October 2016.

Disclosures: This study was supported by the German Ministry of Education and Research (BMBF-PERKAT-13GW0013C). The PERKAT device was developed and designed in cooperation with the Novapump GmbH (Jena, Germany). We thank Ronald Reich, Joerg Pfeifer, Patrick Patzer, and Yu-Jin Heinekamp. The team from Novapump has significantly contributed to the test setup used in the in vitro testing of PERKAT and has been working closely with the authors to implement the suggestions for improved handling of the device. Prof. Dr. M.W. Ferrari is a cofounder and a share-holder in Novapump. For the remaining authors, none were declared.

Correspondence: Daniel Kretzschmar, Department of Internal Medicine I, Division of Cardiology, Friedrich-Schiller-University Jena, Erlanger Allee 101, Jena 07747, Germany. Email: daniel.kretzschmar@med.uni-jena.de.

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Copyright © 2017 by the American Society for Artificial Internal Organs