Publication details

Authors: Olia, Salim E.; Wearden, Peter D.; Maul, Timothy M.; Shankarraman, Venkat; Kocyildirim, Ergin; Snyder, Shaun T.; Callahan, Patrick M.; Kameneva, Marina V.; Wagner, William R.; Borovetz, Harvey S.; Antaki, James F. 
Title: Preclinical performance of a pediatric mechanical circulatory support device: The PediaFlow ventricular assist device 
Type: Journal Article 
Publisher: The Journal of thoracic and cardiovascular surgery  
Year: 2018 
Volume: 156 
Start Page: 1643-1651. 
End Page:  
DOI: 10.1016/j.jtcvs.2018.04.062 
Abstract: OBJECTIVES: The PediaFlow (HeartWare International, Inc, Framingham, Mass) is a miniature, implantable, rotodynamic, fully magnetically levitated, continuous-flow pediatric ventricular assist device. The fourth-generation PediaFlow was evaluated inıvitro and inıvivo to characterize performance and biocompatibility. METHODS: Supported by 2 National Heart, Lung, and Blood Institute contract initiatives to address the limited options available for pediatric patients with congenital or acquired cardiac disease, the PediaFlow was developed with the intent to provide chronic cardiac support for infants as small as 3ıkg. The University of Pittsburgh-led Consortium evaluated fourth-generation PediaFlow prototypes both inıvitro and within a preclinical ovine model (nı=ı11). The latter experiments led to multiple redesigns of the inflow cannula and outflow graft, resulting in the implantable design represented in the most recent implants (nı=ı2). RESULTS: With more than a decade of extensive computational and experimental efforts spanning 4 device iterations, the AA battery-sized fourth-generation PediaFlow has an operating range of 0.5 to 1.5ıL/min with minimal hemolysis inıvitro and excellent hemocompatibility (eg, minimal hemolysis and platelet activation) inıvivo. The pump and finalized accompanying implantable components demonstrated preclinical hemodynamics suitable for the intended pediatric application for up to 60ıdays. CONCLUSIONS: Designated a Humanitarian Use Device for "mechanical circulatory support in neonates, infants, and toddlers weighing up to 20ıkg as a bridge to transplant, a bridge to other therapeutic intervention such as surgery, or as a bridge to recovery" by the Food and Drug Administration, these initial results document the biocompatibility and potential of the fourth-generation PediaFlow design to provide chronic pediatric cardiac support.  
Keywords: *biocompatibility 
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