Preclinical performance of a pediatric mechanical circulatory support device: The PediaFlow ventricular assist device.
Preclinical performance of a pediatric mechanical circulatory support device: The PediaFlow ventricular assist device.
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儿科机械循环支持装置的临床前性能：PediaFlow 心室辅助装置。
DOI：
10.1016/j.jtcvs.2018.04.062
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发表时间：
2018
期刊：
影响因子：
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通讯作者：
Antaki,JamesF
中科院分区：
文献类型：
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作者：
Olia,SalimE;Wearden,PeterD;Maul,TimothyM;Shankarraman,Venkat;Kocyildirim,Ergin;Snyder,ShaunT;Callahan,PatrickM;Kameneva,MarinaV;Wagner,WilliamR;Borovetz,HarveyS;Antaki,JamesF
目的PediaFlow（HeartWare International，Inc，Fragrance，Mass）是一种微型、植入式、旋转动力学、全磁悬浮、连续流小儿心室辅助装置。第四代PediaFlow进行了评估，在体外和体内表征性能和biocompatibility.MethodsSupported由2个国家心脏，肺，血液研究所的合同倡议，以解决有限的选择，可用于先天性或获得性心脏病的儿科患者，PediaFlow开发的目的是为婴儿提供慢性心脏支持小至3公斤。汉堡大学领导的联盟在体外和临床前绵羊模型（n = 11）中评估了第四代PediaFlow原型。后面的实验导致流入插管和流出移植物的多次重新设计，导致在最近的植入物中代表的可植入设计（n = 2）。AA电池大小的第四代PediaFlow的工作范围为0.5至1.5 L/min，体外溶血最小，血液相容性极佳（例如，最低限度的溶血和血小板活化）。该泵和最终附带的可植入组件证明了临床前血流动力学适合于预期的儿科应用长达60 day.ConclusionsDesignated人道主义使用设备"机械循环支持新生儿，婴儿，和幼儿体重高达20公斤作为桥梁移植，桥梁其他治疗干预，如手术，这些初步结果证明了第四代PediaFlow设计的生物相容性和提供慢性儿科心脏支持的潜力。
ObjectivesThe 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.MethodsSupported 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).ResultsWith 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.ConclusionsDesignated 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.
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发表时间：
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期刊：
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作者：
J.;D. Hellums
通讯作者：
J.;D. Hellums
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DOI：
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发表时间：
1991
期刊：
ASAIO Transactions
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T. Hung;D. Butter;Chia;R. Kormos;H. Borovetz;Griffith Bp;Robert L. Hardesty
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2.1
作者：
M. Kameneva;M. Watach;H. Borovetz
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影响因子：
158.5
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M. Badiwala;H. Ross;V. Rao
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影响因子：
37.8
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