Test Procedure for a New Type of a Ventricular Assist Device Based on a Viscous Friction Pump

Abstract

Introduction. Currently, the possibility of effective correction of multiple organ failure and increasing the life expectancy of patients with critical heart failure using the ventricular assist devices (VAD) is absolutely evidenced. The development of alternative analogues of such devices produced within the country has been an urgent problem for many decades. The design of this machine requires the development of a protocol for carrying out complex biomedical studies on the biocompatibility and safety of the new device.The aim of the study was to develop a protocol for testing and conducting comprehensive biomedical biocompatibility studies of a new ventricular assist device in an acute animal experiment.Materials and methods. The study to develop a technique for implanting a left-ventricular assist device (LVAD) in an acute experiment included female mini-pigs, weighed 40-60 kg. In a series of acute experiments, 5 implantations of a disk pump as a LVAD were performed with a maximum observation period equal 6 hours.Results. In the series of acute experiments, an implantation technique was developed and the fundamental possibility of a viscous friction pump application as a ventricular assist device was evidenced. In all experiments (n = 5), the average level of free hemoglobin did not exceed 2.6 mg%, which supports safety of performance of the viscous friction pump regarding blood erythrocytes. None of the experiments recorded episodes of pump shut-off or breakdown.Conclusions. The series of acute experiments on mini-pigs helped reveal a number of anatomical and physiological features of this animal species that significantly complicated implementation of persistent observation. However, the developed experimental LVAD test methodology can be recommended for use in further chronic experiments on large laboratory animals (calves).