Assessment of hydraulic performance and biocompatibility of a MagLev centrifugal pump system designed for pediatric cardiac or cardiopulmonary support.

Abstract The treatment of children with life-threatening cardiac and cardiopulmonary failure is a large andunderappreciated public health concern. We have previously shown that the CentriMag is amagnetically levitated centrifugal pump system, having the utility for treating adults and largechildren (1,500 utilized worldwide). We present here the Pedi-VAS, a pump system whose designwas modified from the CentriMag to meet the physiological requirements of young pediatric andneonatal patients. The PediVAS is comprised of a single-use centrifugal blood pump, reusablemotor, and console, and is suitable for right ventricular assist device (RVAD), left ventricularassist device (LVAD), biventricular assist device (BVAD), or extracorporeal membraneoxygenator (ECMO) applications. It is designed to operate without bearings, seals and valves, andwithout regions of blood stasis, friction, or wear. The PediVAS pump is compatible with theCentriMag hardware, although the priming volume was reduced from 31 to 14 ml, and the portsize reduced from 3/8 to ¼ in. For the expected range of pediatric flow (0.3–3.0 L/min), thePediVAS exhibited superior hydraulic efficiency compared with the CentriMag. The PediVASwas evaluated in 14 pediatric animals for up to 30 days, demonstrating acceptable hydraulicfunction and hemocompatibility. The current results substantiate the performance andbiocompatibility of the PediVAS cardiac assist system and are likely to support initiation of a USclinical trial in the future.In contrast to advances in the development of cardiac support systems for adults, thedevelopment of such systems for children has lagged far behind. The most commonindications for mechanical circulatory support in children is the temporary augmentation ofcardiac performance during and after surgery for congenital heart disease,