Sawa Yoshiki
Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2-2, Yamada-Oka, Osaka, Suita, 565-0871, Japan,
Surg Today. 2015 Jun;45(6):672-81. doi: 10.1007/s00595-014-0957-6. Epub 2014 Aug 21.
Recently, left ventricular assist devices (LVADs) have become a viable therapeutic approach as a bridge to cardiac transplantation, as well as destination therapy or as part of the bridge to recovery. In Japan, paracorporeal pneumatic devices are the only choice for such therapy, as implantable LVADs are not yet generally available due to device lag, which represents a serious problem in this field. Clinical trials of four different continuous-flow pumps, both axial and centrifugal flow types, were completed at about the same time, and two of those devices, DuraHeart and EVAHEART, have already been approved for use in Japan. Thus, reports of advanced treatment for severe heart failure with these devices are expected. The DuraHeart (Terumo Heart, Ann Arbor, MI, USA) and another device named the HeartWare (HeartWare Inc, Miami Lakes, FL, USA) are so-called third-generation devices, as they have achieved miniaturization and improvements in performance from the use of magnetic levitation. Based on our experiences from both clinical research and experimental use, we herein discuss the DuraHeart and HeartWare devices, with a focus on the clinical outcomes and management strategies. Because of the long waiting period for heart transplantation in Japan, these two devices are considered to have important roles in the near future for the treatment of severe heart failure, and a comprehensive strategy for LVAD therapy including such third-generation implantable devices is expected.
最近,左心室辅助装置(LVADs)已成为一种可行的治疗方法,可作为心脏移植的桥梁、终末期治疗或作为恢复桥梁的一部分。在日本,由于设备滞后,植入式LVADs尚未普遍可用,因此体外气动装置是此类治疗的唯一选择,这在该领域是一个严重问题。四种不同的连续流泵(包括轴流和离心流类型)的临床试验大约在同一时间完成,其中两种装置DuraHeart和EVAHEART已在日本获批使用。因此,预计会有关于使用这些装置治疗严重心力衰竭的先进治疗方法的报道。DuraHeart(美国密歇根州安阿伯市泰尔茂心脏公司)和另一种名为HeartWare(美国佛罗里达州迈阿密湖市HeartWare公司)的装置是所谓的第三代装置,因为它们通过使用磁悬浮实现了小型化并提高了性能。基于我们在临床研究和实验使用中的经验,我们在此讨论DuraHeart和HeartWare装置,重点关注临床结果和管理策略。由于在日本心脏移植的等待期很长,这两种装置在不久的将来被认为在治疗严重心力衰竭方面具有重要作用,并且预计会有包括此类第三代植入式装置在内的LVAD治疗的综合策略。