New ISHLT Document on Clinical Cardiac Xenotransplantation
A new ISHLT Document, The 2026 ISHLT Consensus Statement on Clinical Cardiac Xenotransplantation, has been published in JHLT and is available to read online!
Led by Mandeep Mehra, Bruno Reichart, and Muhammad Mohiuddin, this consensus document reflects more than two decades of scientific progress, including the first two pig-to-human heart transplant experiences, and is intended as a living blueprint, to guide clinicians, investigators, regulators, and industry partners as cardiac xenotransplantation enters its next, more disciplined phase.
Developed by a multidisciplinary panel of global experts, this document:
- Synthesizes >20 years of preclinical science and the first pig-to-human heart transplants
- Defines clear preclinical benchmarks and patient selection principles
- Establishes expectations for genetic engineering of source pigs, immunosuppression (with emphasis on costimulatory blockade), organ preservation, and perioperative management
- Sets rigorous standards for immune surveillance, pathology, and infectious risk mitigation
- Outlines pathways for expanded-access cases, pilot studies, and IND/IMPD-qualifying trials, in adults and children
The statement also highlights the importance of robust regulatory oversight, ethical transparency, and long-term follow-up of recipients.
Visit the Standards & Guidelines page for details, top takeaways, and links to read or download the document.