PROJECT SUMMARY
There are over 7,300 heart failure patients listed for a transplant in the US, but in 2022, only 35% received one
and hundreds died or became too sick to remain eligible. The National Academies of Sciences, Engineering,
and Medicine (NASEM) has called for innovations to increase organ availability and longevity. Donation after
circulatory death (DCD) could increase heart availability by up to 30%. However, organs recovered from DCD
donors incur injury due to “ischemic time” – the duration of time an organ is without blood circulation. Ischemic
injury can lead to worse outcomes for recipients of DCD organs compared to recipients of organs recovered
after death by neurologic criteria. Organ injury from ischemic time can be mitigated by perfusion technologies,
either in situ thoracoabdominal normothermic regional perfusion (NRP) via extracorporeal membrane
oxygenation (ECMO) initiation, or ex vivo normothermic machine perfusion (NMP) of individual organs after
surgical extraction.
NRP might enable more high-quality transplants than NMP because all organs can be functionally evaluated
during NRP, and because the less resource-intensive NRP protocol can be implemented more broadly.
Although at least 26 US transplant programs have implemented NRP for DCD, many programs have yet to
adopt NRP due to ethical concerns about restarting circulation, including heartbeat, inside the donor’s body. In
DCD cases, the Uniform Determination of Death Act requires the irreversible cessation of circulatory and
respiratory functions. Because NRP restarts circulation and restores cardiac function in situ, there is concern
that the donor’s death declaration is invalidated. If the donor is not dead, then recovering these organs might
violate the Dead Donor Rule, the ethics principle that requires patients to be dead before removing life-
sustaining organs. These concerns about NRP could potentially jeopardize public trust in the organ transplant
system. We must understand public perceptions toward NRP to know whether its practice could put the
public’s delicate trust in organ transplantation at risk.
The objective of the proposed study is to understand how NRP affects public trust in the organ transplantation
system, and to inform guidelines for how to ethically explain NRP to donor family members who are
approached to authorize organ donation. We first aim to conduct an environmental scan of how procurement
staff request authorization for organ donation involving NRP by surveying and interviewing stakeholders from
all 56 Organ Procurement Organizations. We then aim to assess donor family and public perceptions of the
ethical basis for NRP by conducting focus groups with donor families and a national survey. Lastly, we aim to
use the Delphi method to reach consensus among experts and disseminate ethics guidelines for explaining
NRP to donor family members. Our ethics guidelines will help the 147 heart transplant programs and 56 OPOs
across the nation to decide whether to perform NRP and how to approach family members to promote trust
and transparency in organ donation.
