Baldwin J Timothy, Adachi Iki, Teal John, Almond Christopher A, Jaquiss Robert D, Massicotte M Patricia, Dasse Kurt, Siami Flora S, Zak Victor, Kaltman Jonathan R, Mahle William T, Jarvik Robert
Division of Cardiovascular Sciences, National Heart, Lung and Blood Institute, Bethesda, MD.
Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX; Congenital Heart Surgery, Texas Children's Hospital, Houston, TX.
Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2017 Jan;20:9-15. doi: 10.1053/j.pcsu.2016.09.003.
The Infant Jarvik ventricular assist device (VAD; Jarvik Heart, Inc., New York, NY) has been developed to support the circulation of infants and children with advanced heart failure. The first version of the device was determined to have elevated hemolysis under certain conditions. The objective of this work was to determine appropriate modifications to the Infant Jarvik VAD that would result in acceptably low hemolysis levels. In vitro hemolysis testing revealed that hemolysis was related to the shape of the pump blade tips and a critical speed over which hemolysis would occur. Various design modifications were tested and a final design was selected that met the hemolysis performance goal. The new version was named the Jarvik 2015 VAD. Chronic in vivo tests, virtual fit studies, and a series of other performance tests were carried out to assess the device's performance characteristics. In vivo test results revealed acceptable hemolysis levels in a series of animals and virtual fit studies showed that the device would fit into children 8 kg and above, but could fit in smaller children as well. Additional FDA-required testing has been completed and all of the data are being submitted to the FDA so that a clinical trial of the Jarvik 2015 VAD can begin. Development of a Jarvik VAD for use in young children has been challenging for various reasons. However, with the hemolysis issue addressed in the Jarvik 2015 VAD, the device is well-poised for the start of the PumpKIN clinical trial in the near future.
婴儿版贾维克心室辅助装置（VAD；贾维克心脏公司，纽约州纽约市）已被研发出来，用于支持患有晚期心力衰竭的婴幼儿的血液循环。该装置的第一个版本在某些条件下被确定存在溶血水平升高的问题。这项工作的目的是确定对婴儿版贾维克VAD进行适当修改，以使其溶血水平低至可接受程度。体外溶血测试表明，溶血与泵叶片尖端的形状以及会发生溶血的临界速度有关。对各种设计修改进行了测试，并选择了一个符合溶血性能目标的最终设计。新版本被命名为贾维克2015 VAD。进行了慢性体内测试、虚拟适配研究以及一系列其他性能测试，以评估该装置的性能特征。体内测试结果显示，在一系列动物中溶血水平可接受，虚拟适配研究表明该装置适合8公斤及以上的儿童，但也能适合更小的儿童。美国食品药品监督管理局（FDA）要求的其他测试已经完成，所有数据正在提交给FDA，以便能启动贾维克2015 VAD的临床试验。由于各种原因，研发用于幼儿的贾维克VAD一直具有挑战性。然而，随着贾维克2015 VAD中溶血问题得到解决，该装置在不久的将来准备好启动“小南瓜”（PumpKIN）临床试验。
