Esmore Donald, Kaye David, Spratt Phillip, Larbalestier Robert, Ruygrok Peter, Tsui Steven, Meyers Deborah, Fiane Arnt E, Woodard John
The Alfred Hospital, Melbourne, Australia.
J Heart Lung Transplant. 2008 Jun;27(6):579-88. doi: 10.1016/j.healun.2008.02.012. Epub 2008 Apr 23.
The increasing prevalence of chronic heart failure has stimulated the ongoing development of left ventricular assist devices (LVADs) for both bridge-to-transplant (BTT) and destination therapy (DT). The aim of this prospective, multicenter clinical trial was to determine the efficacy and safety of a third-generation LVAD, the VentrAssist, in a BTT cohort.
Patients (n = 33) with end-stage chronic heart failure who required circulatory support as BTT therapy were implanted with a VentrAssist device. The primary outcome was survival until transplant or transplant eligibility with the device in situ at trial end-point (Day 154 after implant). The secondary outcomes were pump flow index and end-organ function. Safety, patient functional status and resource use were also assessed.
At trial end-point, the success rate was 82% (39.4% transplanted, 42.4% transplant-eligible). The LVAD pump flow index (median >or=2.7 liters/min/m(2)) was sufficient to maintain an adequate circulation and significantly improve end-organ function. Of the 77 protocol-defined serious adverse events, most occurred within 30 days of implantation. No patients died as a direct result of pump failure or malfunction. After implantation, patient functional status improved, with 70% of patients achieving hospital discharge, and resource use was reduced.
This trial demonstrated a favorable efficacy and safety profile for use of the VentrAssist LVAD in BTT patients.
慢性心力衰竭患病率的不断上升推动了用于桥接移植（BTT）和终末期治疗（DT）的左心室辅助装置（LVAD）的持续发展。这项前瞻性多中心临床试验的目的是确定第三代LVAD VentrAssist在BTT队列中的疗效和安全性。
将33例需要循环支持作为BTT治疗的终末期慢性心力衰竭患者植入VentrAssist装置。主要结局是在试验终点（植入后第154天）存活至移植或装置原位符合移植条件。次要结局是泵流量指数和终末器官功能。还评估了安全性、患者功能状态和资源使用情况。
在试验终点，成功率为82%（39.4%接受移植，42.4%符合移植条件）。LVAD泵流量指数（中位数≥2.7升/分钟/平方米）足以维持充足的循环并显著改善终末器官功能。在77例方案定义的严重不良事件中，大多数发生在植入后30天内。没有患者因泵故障或失灵直接死亡。植入后，患者功能状态改善，70%的患者出院，资源使用减少。
该试验证明VentrAssist LVAD用于BTT患者具有良好的疗效和安全性。
