The Journal of Heart and Lung Transplantation · Nov 12, 2026

Disruptions in U.S. Heart Transplantation: When Innovation Outpaces Evidence

By Goldstein DJ, Kanwar MK

For nearly four decades, heart transplantation was defined by a stable, predictable paradigm: brain-dead donors, ice-cooler transport, uniform three-drug immunosuppression, and biopsy-based surveillance. Within a few years, that paradigm has been upended. In this perspective, we examine the disruptions now reshaping heart transplantation in the United States. Some are desirable: new preservation platforms and the rapid growth of donation after circulatory death, which now accounts for nearly a quarter of U.S. heart transplants, have expanded the donor pool, and cardiac xenotransplantation has reached clinical testing. Others remain controversial: the 2018 allocation policy has altered listing and support practices, normothermic regional perfusion raises unresolved questions about the determination of death, and inconsistent definitions of ischemic intervals undermine comparisons across DCD studies. Still others are troubling: OPTN restructuring, uneven OPO performance, outsourced procurement, rising costs, and press reports of donors showing signs of life have strained public trust. Underlying all of these is a data gap: national registries capture few DCD procurement and preservation variables, and little about recipients’ long-term health beyond survival. Innovation has outpaced our ability to evaluate its consequences. We propose a shared DCD clock built on fixed timestamps, national ethical standards for normothermic regional perfusion, transparency in procurement and its costs, longitudinal outcome reporting, and accountability shared by OPOs and transplant centers. The challenge facing the field is no longer simply how to transplant more hearts, but how to ensure that more transplantation becomes better transplantation.

doi.org/10.1016/j.healun.2026.11.003PubMed 43020396Industry & policy