PERKAT RV: first in vivo data of a novel right heart assist device

Abstract

AIMS: Mechanical right ventricular (RV) support offers a treatment option for critically ill patients with RV failure (RVF). We developed an assist device for rapid percutaneous implantation. The aim of the present study was to investigate the implantation procedure, haemodynamic performance and possible side effects of the novel right ventricular assist device - PERKAT RV - in an animal model. METHODS AND RESULTS: The PERkutane KATheterpumptechnologie RV (PERKAT RV) device consists of a nitinol chamber covered by foil containing inflow valves. An outlet tube is attached to its distal part. The system is designed for 18 Fr percutaneous implantation. The chamber is unfolded in the inferior vena cava while the outlet tube bypasses the right heart with the tip in the pulmonary trunk. An IABP balloon is placed inside. Balloon deflation generates blood flow into the chamber; during inflation, blood is guided into the pulmonary arteries. Acute RVF was induced by venous injection of Sephadex in seven sheep for evaluation of the device. The PERKAT RV was able to improve haemodynamics immediately generating a median increase in cardiac output of 59%. Longer pump support was evaluated in a second study. Four sheep were supported for eight hours without any problems. CONCLUSIONS: The percutaneous implantation and explantation of the PERKAT RV device was possible in the designed way. The sheep studies proved beneficial haemodynamic effects in acute RVF. The system offers easy and safe treatment in acute RVF.