ICET Laboratory, Critical Care Research Group, The Prince Charles Hospital and University of Queensland, Brisbane, Australia.
Med Eng Phys. 2011 Nov;33(9):1041-7. doi: 10.1016/j.medengphy.2011.04.010. Epub 2011 Jun 12.
Given the limited availability of donor hearts, ventricular assist device (VAD) therapy is fast becoming an accepted alternative treatment strategy to treat end-stage heart failure. The field of mechanical ventricular assistance is littered with novel and unique ideas either based on volume displacement or rotary pump technology, which aim to sufficiently restore cardiac output. However, only a select few have made the transition to the clinical arena. Clinical implants were initially dominated by the FDA approved volume displacement Thoratec HeartMate I, IVAD, and PVAD, whilst Berlin Heart's EXCOR, and Abiomed's BVS5000 and AB5000 offered suitable alternatives. However, limitations associated with an inherently large size and reduced lifetime of these devices stimulated the development and subsequent implantation of rotary blood pump (RBP) technology. Almost all of the reviewed RBPs are clinically available in Europe, whilst many are still undergoing clinical trial in the USA. Thoratec's HeartMate II is currently the only rotary device approved by the FDA, and has supported the highest number of patients to date. This pump is joined by MicroMed Cardiovascular's Heart Assist 5 Adult VAD, Jarvik Heart's Jarvik 2000 FlowMaker and Berlin Heart's InCOR as the axial flow devices under investigation in the USA. More recently developed radial flow devices such as WorldHeart's Levacor, Terumo's DuraHeart, and HeartWare's HVAD are increasing in their clinical trial patient numbers. Finally CircuLite's Synergy and Abiomed's Impella are two mixed flow type devices designed to offer partial cardiac support to less sick patients. This review provides a brief overview of the volume displacement and rotary devices which are either clinically available, or undergoing the advanced stages of human clinical trials.
鉴于供体心脏的有限可用性,心室辅助装置 (VAD) 治疗迅速成为治疗终末期心力衰竭的可接受替代治疗策略。机械心室辅助领域充满了新颖独特的想法,这些想法基于容积置换或旋转泵技术,旨在充分恢复心输出量。然而,只有少数几个想法成功过渡到临床领域。临床植入物最初由获得 FDA 批准的容积置换型 Thoratec HeartMate I、IVAD 和 PVAD 主导,而 Berlin Heart 的 EXCOR 和 Abiomed 的 BVS5000 和 AB5000 提供了合适的替代品。然而,这些设备固有的尺寸大和使用寿命有限的局限性刺激了旋转血泵 (RBP) 技术的发展和随后的植入。几乎所有审查的 RBP 都在欧洲临床可用,而许多仍在美国进行临床试验。Thoratec 的 HeartMate II 是目前唯一获得 FDA 批准的旋转设备,迄今为止已支持最多的患者。该泵与 MicroMed Cardiovascular 的 Heart Assist 5 成人 VAD、Jarvik Heart 的 Jarvik 2000 FlowMaker 和 Berlin Heart 的 InCOR 一起作为美国正在研究的轴流设备。最近开发的径向流设备,如 WorldHeart 的 Levacor、Terumo 的 DuraHeart 和 HeartWare 的 HVAD,其临床试验患者数量正在增加。最后,CircuLite 的 Synergy 和 Abiomed 的 Impella 是两种混合流类型的设备,旨在为病情较轻的患者提供部分心脏支持。这篇综述简要概述了临床可用或正在进行人体临床试验的高级阶段的容积置换和旋转设备。