Burki Sarah, Adachi Iki
Division of Congenital Heart Surgery, Texas Children's Hospital.
Department of Surgery and Pediatrics, Baylor College of Medicine, Houston, TX, USA.
Vasc Health Risk Manag. 2017 May 15;13:177-185. doi: 10.2147/VHRM.S82379. eCollection 2017.
The field of mechanical circulatory support has made great strides in the preceding 2 decades. Although pediatric mechanical circulatory support has lagged behind that of adults, the gap between them is expected to close soon. The only device currently approved by the US Food and Drug Administration for use in children is the Berlin Heart EXCOR ventricular assist device (VAD). The prospective Berlin Heart Investigational Device Exemption Trial demonstrated good outcomes, such as bridge to transplantation or recovery, in ~90% of children supported with this device. However, a high incidence of hemorrhagic and thrombotic complications was also noted. As a result, pediatric centers have just started implanting adult intracorporeal continuous-flow devices in children. This paradigm shift has opened a new era in pediatric mechanical circulatory support. Whereas children on VAD were previously managed exclusively in hospital, therapeutic options such as outpatient management and even destination therapy have been becoming a reality. With continued miniaturization and technological refinements, devices currently in development will broaden the range of options available to children. The HeartMate 3 and HeartWare MVAD are two such compact VADs, which are anticipated to have great potential for pediatric use. Additionally, a pediatric-specific continuous-flow VAD, the newly redesigned Jarvik Infant 2015, is currently undergoing preclinical testing and is expected to undergo a randomized clinical trial in the near future. This review aims to discuss the challenges posed by the use of intracorporeal adult continuous-flow devices in children, as well as to provide our perspective on the future prospects of the field of pediatric VADs.
在过去的20年里，机械循环支持领域取得了巨大进展。尽管小儿机械循环支持落后于成人，但预计两者之间的差距将很快缩小。目前美国食品药品监督管理局批准用于儿童的唯一设备是柏林心脏EXCOR心室辅助装置（VAD）。前瞻性的柏林心脏研究性器械豁免试验表明，在使用该装置支持的儿童中，约90%取得了良好的结果，如过渡到移植或康复。然而，也注意到出血和血栓形成并发症的发生率很高。因此，儿科中心刚刚开始在儿童中植入成人体内心脏连续血流装置。这种模式转变开启了小儿机械循环支持的新时代。以前，使用VAD的儿童只能在医院接受治疗，而现在，诸如门诊治疗甚至目标治疗等治疗选择已成为现实。随着设备不断小型化和技术改进，目前正在研发的设备将扩大儿童可用的选择范围。HeartMate 3和HeartWare MVAD就是这样两种紧凑型VAD，预计它们在儿科应用方面具有巨大潜力。此外，一种专门为儿童设计的连续血流VAD——新重新设计的2015版Jarvik婴儿型VAD，目前正在进行临床前测试，预计在不久的将来将进行随机临床试验。这篇综述旨在讨论在儿童中使用成人体内心脏连续血流装置所带来的挑战，并提供我们对小儿VAD领域未来前景的看法。
