VentrAssist左心室辅助装置的初步临床经验：试点试验。
Initial clinical experience with the VentrAssist left ventricular assist device: the pilot trial.
作者信息
Esmore Donald S, Kaye David, Salamonsen Robert, Buckland Mark, Begg John R, Negri Justin, Ayre Peter, Woodard John, Rosenfeldt Franklin L
机构信息
Department of Cardiothoracic Surgery, Alfred Hospital, Prahran, Victoria, Australia.
出版信息
J Heart Lung Transplant. 2008 May;27(5):479-85. doi: 10.1016/j.healun.2008.02.003.
BACKGROUND
The VentrAssist (VA) is a novel, continuous flow left ventricular assist device (LVAD). The purpose of this trial was to investigate the safety and efficacy of the VA in elderly patients with end-stage heart failure.
METHODS
In this prospective trial, patients requiring circulatory support either as destination therapy (DT) or as a bridge to transplant (BTT) were implanted with a VA device.
RESULTS
Between June 2003 and August 2006, 9 elderly patients (mean age 65 years) were implanted. The median support time was 454 (range 73 to 977) days for the DT and 35 (range 26 to 508) days for the BTT cohort. All patients survived implantation; 30-day mortality was 22% (n = 2). The adverse event profile was encouraging, with no embolic neurologic events and minimal sepsis. Cumulative trial support time was 7.3 patient-years.
CONCLUSIONS
The VentrAssist shows promise as a safe and reliable "third-generation" VAD. Having demonstrated potential as a DT and prolonged BTT device, extended clinical trials are warranted.
背景
VentrAssist（VA）是一种新型的连续血流左心室辅助装置（LVAD）。本试验的目的是研究VA在老年终末期心力衰竭患者中的安全性和有效性。
方法
在这项前瞻性试验中，需要作为目标治疗（DT）或作为移植过渡（BTT）接受循环支持的患者植入了VA装置。
结果
在2003年6月至2006年8月期间，9名老年患者（平均年龄65岁）接受了植入。DT组的中位支持时间为454天（范围73至977天），BTT组为35天（范围26至508天）。所有患者植入后均存活；30天死亡率为22%（n = 2）。不良事件情况令人鼓舞，无栓塞性神经事件，败血症极少。试验累计支持时间为7.3患者年。
结论
VentrAssist作为一种安全可靠的“第三代”VAD显示出前景。已证明其作为DT和延长BTT装置的潜力，有必要进行扩展的临床试验。
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