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J Thorac Cardiovasc Surg. 2018 Oct;156(4):1643-1651.e7. doi: 10.1016/j.jtcvs.2018.04.062. Epub 2018 Apr 21.

Preclinical performance of a pediatric mechanical circulatory support device: The PediaFlow ventricular assist device.

Author information

1
Department of Bioengineering, University of Pittsburgh, Pittsburgh, Pa; McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pa; Artificial Heart Program, University of Pittsburgh Medical Center, Pittsburgh, Pa.
2
Department of Bioengineering, University of Pittsburgh, Pittsburgh, Pa; McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pa; Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, Pa; Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pa.
3
McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pa.
4
McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pa; Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, Pa.
5
LaunchPoint Technologies LLC, Goleta, Calif.
6
McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pa; Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, Pa; Department of Anesthesiology, University of Pittsburgh, Pittsburgh, Pa.
7
Department of Bioengineering, University of Pittsburgh, Pittsburgh, Pa; McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pa; Department of Surgery, University of Pittsburgh, Pittsburgh, Pa.
8
Department of Bioengineering, University of Pittsburgh, Pittsburgh, Pa; McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pa; Department of Surgery, University of Pittsburgh, Pittsburgh, Pa; Department of Chemical and Petroleum Engineering, University of Pittsburgh, Pittsburgh, Pa.
9
McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, Pa; Department of Biomedical Engineering, Carnegie Mellon University, Pittsburgh, Pa. Electronic address: antaki@cornell.edu.

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 in vitro and in vivo 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 3 kg. The University of Pittsburgh-led Consortium evaluated fourth-generation PediaFlow prototypes both in vitro and within a preclinical ovine model (n = 11). 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 (n = 2).

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 1.5 L/min with minimal hemolysis in vitro and excellent hemocompatibility (eg, minimal hemolysis and platelet activation) in vivo. The pump and finalized accompanying implantable components demonstrated preclinical hemodynamics suitable for the intended pediatric application for up to 60 days.

CONCLUSIONS:

Designated a Humanitarian Use Device for "mechanical circulatory support in neonates, infants, and toddlers weighing up to 20 kg 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; blood pump; congenital heart disease; continuous flow; hemocompatibility; pediatric heart failure

PMID:
29807773
PMCID:
PMC6292205
[Available on 2019-10-01]
DOI:
10.1016/j.jtcvs.2018.04.062

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