Abstract

We are grateful for the thoughtful commentaries to our article on patient selection for first clinical trials of cardiac xenotransplantation1 because they give us the opportunity to clarify and further sharpen our arguments in this response. In our article, we proposed a multicriteria approach to selecting patients for first clinical trials of (cardiac) xenotransplantation, encompassing the four criteria medical need, capacity to benefit, patient choice and compliance (used as an exclusion criterion). We also argued that clinical trials following clearly defined study protocols should be favoured over further single compassionate use cases to gather reliable and valid knowledge about the benefits and risks of xenotransplantation. Continuous poor outcomes in compassionate use cases can impede a technology’s development. For example, early heart transplants led to moratoria in several countries due to public and professional backlash. This historical concern is also echoed within the xenotransplantation research community and should be considered when arguing, as Aparicio et al do in their comment, for continuing the expanded access pathway to further establish clinical xenotransplantation.2 We agree with Aparicio et al that patients in general should have access to innovative treatment strategies via expanded access. In cardiac xenotransplantation, however, only a small number of patients can currently be offered a xenotransplant because of …