Biocompatibility assessment of the first generation PediaFlow pediatric ventricular assist device

Johnson, Carl A; Vandenberghe, Stijn; Daly, Amanda R; Woolley, Joshua R; Snyder, Shaun T; Verkaik, Josiah E; Ye, Sang-Ho; Borovetz, Harvey S; Antaki, James F; Wearden, Peter D; Kameneva, Marina V; Wagner, William R (2011). Biocompatibility assessment of the first generation PediaFlow pediatric ventricular assist device. Artificial organs, 35(1), pp. 9-21. Malden, Mass.: Wiley-Blackwell 10.1111/j.1525-1594.2010.01023.x

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiovascular Surgery

UniBE Contributor:

Vandenberghe, Stijn

ISSN:

0160-564X

Publisher:

Wiley-Blackwell

Language:

English

Submitter:

Factscience Import

Date Deposited:

04 Oct 2013 14:20

Last Modified:

11 Jul 2014 08:03

Publisher DOI:

10.1111/j.1525-1594.2010.01023.x

PubMed ID:

20626737

Web of Science ID:

000286209000004

URI:

https://boris.unibe.ch/id/eprint/6644 (FactScience: 211642)

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