Pig-to-human heart transplantation: Who goes first?
Pig-to-human heart transplantation: Who goes first?
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DOI：
10.1111/ajt.15916
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发表时间：
2020-10
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影响因子：
--
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中科院分区：
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--
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异种心脏移植最近向临床迈出了重要的一步。在对“首例人类”异种心脏移植试验的预期中，我们提出了一组确定潜在候选者的患者特征。我们的前提是，为了在伦理上合理，当前最先进的选择带来的风险必须超过开创性的异种移植程序的预期风险。合适的候选对象包括因对同种异体抗原致敏而处于高免疫风险的患者，包括那些表现出早期发病或加速的同种异体心脏移植血管病变的患者。此外，应考虑以下患者：(1)由于高凝状态、抗凝禁忌症或生理限制，机械循环支持风险极高；(2)严重的双室功能障碍预示着单室左心支持失败；(3)成人复杂先天性心脏病。总而言之，由于发表的异种心脏移植临床前基准似乎触手可及，仔细和刻意地定义适当的试验参与者是及时的，作为伦理临床试验设计的基础。
Cardiac xenotransplantation has recently taken an important step towards clinical reality. In anticipation of the “first-in-human” heart xenotransplantation trial, we propose a set of patient characteristics that define potential candidates. Our premise is that, to be ethically justified, the risks posed by current state-of-the-art options must outweigh the anticipated risks of a pioneering xenotransplant procedure. Suitable candidates include patients who are at high immunologic risk because of sensitization to alloantigens, including those who have exhibited early onset or accelerated cardiac allograft vasculopathy. In addition, patients should be considered (1) for whom mechanical circulatory support would be prohibitively risky due to a hypercoagulable state, a contraindication to anticoagulation, or restrictive physiology; (2) with severe biventricular dysfunction predicting unsuccessful univentricular left heart support; and (3) adults with complex congenital heart disease. In conclusion, because the published preclinical benchmark for clinical translation of heart xenotransplantation appears within reach, carefully and deliberately defining appropriate trial participants is timely as the basis for ethical clinical trial design.
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