Investigating Donor Authorization and Public Perceptions of Normothermic Regional Perfusion to Inform Ethical Organ Donation Practices

NIH RePORTER · NIH · R01 · $782,639 · view on reporter.nih.gov ↗

Abstract

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 de...

Key facts

NIH application ID
10858372
Project number
1R01HL173157-01
Recipient
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
Principal Investigator
Brendan Parent
Activity code
R01
Funding institute
NIH
Fiscal year
2024
Award amount
$782,639
Award type
1
Project period
2024-04-01 → 2029-02-28