More than 1000 donated aortic and pulmonary valves from predominantly European tissue banks were centrally decellularized and delivered to hospitals in Europe and Japan. Here, we report on the processing and quality controls before, during and after the decellularization of these allografts. Our experiences show that all tissue establishments, which provide native cardiovascular allografts for decellularization, meet comparably high-quality standards, regardless of their national origin. A total of 84% of all received allografts could be released as cell-free allografts. By far the most frequent reasons for rejection were non-release of the donor by the tissue establishment or severe contaminations of the native tissue donation. Only in 2% of all cases the specification for freedom from cells was not fulfilled, indicating that decellularization of human heart valves is a safe process with a very low discard ratio. In clinical use, cell-free cardiovascular allografts have been shown to be advantageous over conventional heart valve replacements, at least in young adults. These results open the discussion on the future gold standard and funding of this innovative therapeutic option for heart valve replacement.

来自主要是欧洲组织库的 1000 多个捐赠的主动脉瓣和肺动脉瓣被集中去细胞化并运送到欧洲和日本的医院。在这里，我们报告了这些同种异体移植物去细胞化之前、期间和之后的处理和质量控制。我们的经验表明，所有提供用于去细胞化的天然心血管同种异体移植物的组织机构，无论其国籍如何，都符合相对高质量的标准。总共 84% 的所有接受的同种异体移植物可以作为无细胞同种异体移植物释放。到目前为止，拒绝的最常见原因是组织机构未释放供体或天然组织捐献的严重污染。只有 2% 的案例没有达到不含细胞的规格，表明人类心脏瓣膜的去细胞化是一个安全的过程，丢弃率非常低。在临床应用中，无细胞心血管同种异体移植物已被证明优于传统的心脏瓣膜置换术，至少在年轻人中如此。这些结果开启了关于未来黄金标准的讨论以及为这种心脏瓣膜置换的创新治疗选择提供资金。