Current address: ARTORG Cardiovascular Engineering, University of Bern, Bern, Switzerland.
Biocompatibility Assessment of the First Generation PediaFlow Pediatric Ventricular Assist Device
Article first published online: 9 JUL 2010
© 2010, Copyright the Authors. Artificial Organs © 2010, International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.
Volume 35, Issue 1, pages 9–21, January 2011
How to Cite
Johnson Jr, C. A., Vandenberghe, S., Daly, A. R., Woolley, J. R., Snyder, S. T., Verkaik, J. E., Ye, S.-H., Borovetz, H. S., Antaki, J. F., Wearden, P. D., Kameneva, M. V. and Wagner, W. R. (2011), Biocompatibility Assessment of the First Generation PediaFlow Pediatric Ventricular Assist Device. Artificial Organs, 35: 9–21. doi: 10.1111/j.1525-1594.2010.01023.x
[Corrections made after online publication on 9 July 2010: The data in the “Inflow cannula” column, and “Mean Arterial Pressure” column for Table 1 have been amended.]
- Issue published online: 13 JAN 2011
- Article first published online: 9 JUL 2010
- Received October 2009; revised January 2010.
- Pediatric ventricular assist devices;
- Biocompatibility assessment;
- Platelet activation;
- Magnetic levitation
The PediaFlow pediatric ventricular assist device is a miniature magnetically levitated mixed flow pump under development for circulatory support of newborns and infants (3–15 kg) with a targeted flow range of 0.3–1.5 L/min. The first generation design of the PediaFlow (PF1) was manufactured with a weight of approximately 100 g, priming volume less than 2 mL, length of 51 mm, outer diameter of 28 mm, and with 5-mm blood ports. PF1 was evaluated in an in vitro flow loop for 6 h and implanted in ovines for three chronic experiments of 6, 17, and 10 days. In the in vitro test, normalized index of hemolysis was 0.0087 ± 0.0024 g/100L. Hemodynamic performance and blood biocompatibility of PF1 were characterized in vivo by measurements of plasma free hemoglobin, plasma fibrinogen, total plasma protein, and with novel flow cytometric assays to quantify circulating activated ovine platelets. The mean plasma free hemoglobin values for the three chronic studies were 4.6 ± 2.7, 13.3 ± 7.9, and 8.8 ± 3.3 mg/dL, respectively. Platelet activation was low for portions of several studies but consistently rose along with observed animal and pump complications. The PF1 prototype generated promising results in terms of low hemolysis and platelet activation in the absence of complications. Hemodynamic results validated the magnetic bearing design and provided the platform for design iterations to meet the objective of providing circulatory support for young children with exceptional biocompatibility.