Heart & Diabetes Center, North Rhine-Westphalia, Georgstrasse 11, 32545 Bad Oeynhausen, Germany.
Expert Rev Med Devices. 2010 Mar;7(2):173-83. doi: 10.1586/erd.09.68.
The implantable left ventricular assist system (LVAS) using pulsatile pump technology has become an established therapeutic option for advanced heart failure patients. However, there have been technological limitations in some older designs, including a high incidence of infection and mechanical failures associated with moving parts, and the large size of both implantable pump and percutaneous cable. A smaller rotary blood pump emerged as a possible alternative to a large pulsatile pump to overcome some of these limitations. The technological advancement that defines the third-generation LVAS was the elimination of all mechanical contacts between the impeller and the drive mechanism. The DuraHeart LVAS is the world's first third-generation implantable LVAS to obtain market approval (CE-mark), which combines a centrifugal pump and active magnetic levitation. The initial clinical experience with the DuraHeart LVAS in Europe demonstrated that it provided significantly improved survival (85% at 6 months and 79% at 1 year), reduced adverse event rates and long-term device reliability (freedom from device replacement at 2 years: 96 +/- 3%) over pulsatile LVAS.
采用搏动泵技术的植入式左心室辅助系统(LVAS)已成为晚期心力衰竭患者的一种既定治疗选择。然而,一些较旧设计存在技术限制,包括与活动部件相关的高感染率和机械故障发生率,以及植入式泵和经皮电缆的体积较大。较小的旋转血泵作为大型搏动泵的替代方案出现,以克服其中的一些限制。定义第三代 LVAS 的技术进步是消除叶轮和驱动机构之间的所有机械接触。DuraHeart LVAS 是世界上第一个获得市场批准(CE 标志)的第三代植入式 LVAS,它结合了离心泵和主动磁悬浮。DuraHeart LVAS 在欧洲的初步临床经验表明,与搏动性 LVAS 相比,它提供了显著改善的生存率(6 个月时为 85%,1 年时为 79%),降低了不良事件发生率和长期设备可靠性(2 年时无设备更换:96 +/- 3%)。