LEVITRONIX CENTRIMAG® SHORT-TERM VENTRICULAR ASSIST SYSTEM IN THE BOVINE MODEL

Abstract

The Levitronix CentriMag® Blood Pump is the first disposable centrifugal pump designed for short-term ventricular assistance (LVAD). The device, based on advanced magnetic levitation technology, allows for operation in blood without mechanical bearings and seals. Preclinical studies were conducted in vivo to demonstrate safety of the CentriMag®. The device was implanted (n=5) surgically via left thorocotomy. The inlet and outlet cannulae were inserted into the left ventricular apex and the descending aorta, respectively. All calves were anticoagulated with heparin and coumadin. The pump was run continuously for 1 month (2X safety factor for humans). Pump speed was adjusted to maintain a target flow of 5.0L/min. Plasma free hemoglobin (PFH), complete blood count, chemistry, and coagulation profiles were determined on a daily basis. At study term, full necropsy and histology were performed. Pump data were collected for an average of 28±2 days. The average pump speed was 3300±300 rpm; corresponding average flow was 5.0±2.0 L/min. All calves reached the scheduled end point without exhibiting any hemolysis, end-organ dysfunction, or adverse effects related to the device. Renal and hepatic function, hematological parameters, and PFH remained normal. Our data indicate that the Levitronix CentriMag® pump is an easily implantable, thrombus-free, and nonhemolytic centrifugal LVAD that provides adequate flow. This suggests that the device is ready for clinical use as a short-term LVAD.