Operationalizing Cardiac Xenotransplantation: An Administrative Playbook

As the field of xenotransplantation advances, institutions must navigate a complex landscape of nonclinical challenges to ensure safe and ethical implementation. This article presents a detailed account of the planning and execution of the first 2 human cardiac xenotransplants performed at the University of Maryland School of Medicine and Medical Center. Beyond the surgical innovation, these procedures required extensive coordination across regulatory, ethical, financial, legal, administrative, and operational domains. Drawing from institutional experience—including after-action analyses and interdisciplinary collaboration—we outline key strategies for Food and Drug Administration authorization, staff education, infection control, financial structuring, and communications planning. We also explore ethical considerations in patient selection and consent, emphasizing transparency, autonomy, and public health safeguards. This article serves as a practical guide for institutions preparing to undertake xenotransplantation, offering insights into the infrastructure and foresight necessary to support this transformative but complex medical advance.