Advanced Technologies & Surgery Branch, Basic and Early Technology Research Program, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD 20892-7940, USA.
J Card Fail. 2010 Nov;16(11):855-8. doi: 10.1016/j.cardfail.2010.06.414.
Ventricular assist devices (VADs) are used to bridge heart failure patients to transplantation, to allow their own hearts to recover, or as permanent ("destination") therapy. To date, the use of VADs has been limited to late-stage heart failure patients because of the associated device risks. In 2008, a National Heart, Lung, and Blood Institute (NHLBI) working group met to evaluate the treatment of heart failure using VADs and to advise the institute on how therapy for heart failure may be best advanced by clinical trials involving the devices.
Recognizing the improvements in VAD technology and in patient care and selection over the past decade, the working group recommended that a trial be performed to assess the use of chronic VAD therapy in patients who are less ill than those currently eligible for destination therapy. The hypothesis proposed for the trial is that VAD therapy may improve both survival and quality of life in moderately advanced heart failure patients who are neither inotrope-dependent nor exercise-intolerant and have not yet developed serious consequences such as malnourishment, end-organ damage, and immobility.
Based on the group's recommendations, NHLBI issued an RFP in 2009 for the REVIVE-IT Pilot Trail, which will serve to test the hypothesis and inform the pivotal trial.
心室辅助装置（VAD）用于桥接心力衰竭患者进行移植，使他们自己的心脏得以恢复，或作为永久性（“目的地”）治疗。迄今为止，由于相关设备风险，VAD 的使用仅限于晚期心力衰竭患者。2008 年，美国国立心肺血液研究所（NHLBI）工作组开会评估使用 VAD 治疗心力衰竭，并就如何通过涉及设备的临床试验来最好地推进心力衰竭治疗向研究所提供建议。
工作组认识到过去十年中 VAD 技术以及患者护理和选择方面的改进，建议进行一项试验，以评估慢性 VAD 治疗在病情较轻的患者中的应用，这些患者目前不符合目的地治疗的条件。该试验提出的假设是，VAD 治疗可能会改善既非依赖于正性肌力药物又非运动不耐受且尚未出现营养不良、终末器官损伤和活动受限等严重后果的中度晚期心力衰竭患者的生存和生活质量。
基于该小组的建议，NHLBI 在 2009 年发布了 REVIVE-IT 先导试验的 RFP，该试验将用于检验假设并为关键试验提供信息。
