Division of Cardiothoracic Surgery and Department of Medicine, University of Louisville, Louisville, Kentucky 40202, USA.
J Heart Lung Transplant. 2013 Jul;32(7):675-83. doi: 10.1016/j.healun.2013.04.004.
The HeartWare Ventricular Assist System (HeartWare Inc, Framingmam, MA) is a miniaturized implantable, centrifugal design, continuous-flow blood pump. The pivotal bridge to transplant and continued access protocols trials have enrolled patients with advanced heart failure in a bridge-to-transplant indication.
The primary outcome, success, was defined as survival on the originally implanted device, transplant, or explant for ventricular recovery at 180 days. Secondary outcomes included an evaluation of survival, functional and quality of life outcomes, and adverse events.
A total of 332 patients in the pivotal bridge to transplant and continued access protocols trial have completed their 180-day primary end-point assessment. Survival in patients receiving the HeartWare pump was 91% at 180 days and 84% at 360 days. Quality of life scores improved significantly, and adverse event rates remain low.
The use of the HeartWare pump as a bridge to transplant continues to demonstrate a high 180-day survival rate despite a low rate of transplant. Adverse event rates are similar or better than those observed in historical bridge-to-transplant trials, despite longer exposure times due to longer survival and lower transplant rates.
HeartWare 心室辅助系统（HeartWare Inc，Framingham，MA）是一种小型化、植入式、离心式设计的连续血流泵。关键性桥接至移植和持续通路协议试验已招募了具有晚期心力衰竭的患者作为桥接至移植适应证。
主要结局为成功，定义为最初植入的设备、移植或心室恢复的 180 天内的心脏辅助泵上的存活。次要结局包括生存、功能和生活质量结果以及不良事件的评估。
在关键性桥接至移植和持续通路协议试验中，共 332 例患者完成了他们的 180 天主要终点评估。接受 HeartWare 泵治疗的患者在 180 天的生存率为 91%，在 360 天的生存率为 84%。生活质量评分显著改善，不良事件发生率仍然较低。
尽管移植率较低，但 HeartWare 泵作为桥接的使用继续显示出较高的 180 天生存率。不良事件发生率与历史桥接至移植试验相似或更好，尽管由于生存率较高和移植率较低导致暴露时间更长。
