Miller P J, Billich T J, LaForge D H, Lee J, Naegeli A, Ramasamy N, Jassawalla J S, Portner P M
Novacor Division, Baxter Healthcare Corporation, Oakland, CA 94621, USA.
ASAIO J. 1994 Jul-Sep;40(3):M465-70. doi: 10.1097/00002480-199407000-00043.
The Novacor left ventricular assist system (LVAS), an implanted electromechanically driven blood pump, has been used in an ongoing clinical trial as a bridge to cardiac transplantation since 1984. The initial configuration included a console based extracorporeal controller. Because patients supported by the device usually become rehabilitated and highly mobile, a wearable control system was developed for the ambulatory patient. Ergonomically designed for portability, comfort, and appearance, it offers the recipient greater mobility, improved self-image, and an enhanced quality of life. This wearable control system consists of a microprocessor based compact controller that drives the implanted pump/drive unit in synchronous counterpulsation to the native heart. Main and reserve rechargeable power packs, each incorporating a "smart" monitoring circuit with charge-level display and alarm, are capable of supporting the pump for as long as 7 hr. An LVAS monitor can be connected to the controller for device monitoring and adjustment or as a power supply in lieu of the main power pack. Clinical evaluation in patients with end-stage heart disease followed the same protocol as the console study. By April 4, 1994, 41 patients had been supported by the wearable system, including 9 patients currently being supported. Mean duration of use was 51 days (range, 1.5-143+ days), compared with 42 days for 170 console patients (range, 0-370 days). Survival to transplant was 66%, which was similar to the survival (60%) for the patients using the console. Post-transplant survival was 100%, compared with 90% for console patients (not significantly different). After recovering from implant surgery and pre-implant morbidity, device recipients had considerable freedom and mobility and were able to move freely within and outside the hospital. Recipients could readily switch between monitored and untethered operation and could manage power pack replacement and recharging.
诺瓦科尔左心室辅助系统（LVAS）是一种植入式机电驱动血泵，自1984年以来一直在一项正在进行的临床试验中用作心脏移植的桥梁。最初的配置包括一个基于控制台的体外控制器。由于使用该设备支持的患者通常会康复并具有很高的活动能力，因此为门诊患者开发了一种可穿戴控制系统。该系统在人体工程学上进行了设计，以实现便携性、舒适性和美观性，为接受者提供了更大的活动能力、改善的自我形象和更高的生活质量。这种可穿戴控制系统由一个基于微处理器的紧凑型控制器组成，该控制器以与天然心脏同步反搏的方式驱动植入的泵/驱动单元。主电源组和备用可充电电源组均包含一个带有电量显示和警报功能的“智能”监测电路，能够为泵提供长达7小时的支持。一个LVAS监测器可以连接到控制器，用于设备监测和调整，或者作为主电源组的替代电源。对终末期心脏病患者的临床评估遵循与控制台研究相同的方案。到1994年4月4日，有41名患者使用了可穿戴系统，其中9名患者目前仍在使用该系统。平均使用时间为51天（范围为1.5 - 143 +天），而170名使用控制台系统的患者平均使用时间为42天（范围为0 - 370天）。移植存活率为66%，与使用控制台系统的患者存活率（60%）相似。移植后存活率为100%，而控制台患者为90%（无显著差异）。在从植入手术和植入前发病中恢复后，设备接受者有相当大的自由和活动能力，能够在医院内外自由活动。接受者可以轻松地在监测操作和无束缚操作之间切换，并且能够管理电源组的更换和充电。
