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Pig‐to‐human heart transplantation: Who goes first?
Author(s) -
Pierson Richard N.,
Burdorf Lars,
Madsen Joren C.,
Lewis Gregory D.,
D’Alessandro David A.
Publication year - 2020
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/ajt.15916
Subject(s) - xenotransplantation , medicine , contraindication , intensive care medicine , heart transplantation , transplantation , anticipation (artificial intelligence) , cardiac allograft vasculopathy , clinical trial , premise , heart disease , human heart , cardiology , surgery , pathology , alternative medicine , artificial intelligence , computer science , linguistics , philosophy
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.