Pub Date: Tuesday, Aug 08, 2023
Author: Blair Henry, D. Bioethics
Affiliation: University of Toronto
Recent news of the death of the first human recipient of a genetically edited pig heart has sent a shock wave through the organ transplantation community. Initial reports presented a hopeful picture for a new source of viable organ supply using gene-editing technology and xenotransplantation. Though still under investigation as to the definitive cause of its failure, plans remain underway for research trials to commence later this year to fully assess this new opportunity. This movement forward speaks to the continuing demand and priority being placed on behalf of individuals desperately awaiting an organ donation to get a second lease on life.1
The balance and sacredness of honoring the cycle of life, and death are nowhere more apparent than in the field of organ donation and transplantation. Meeting the ever-increasing demand for organ donation is a global problem with a unique set of regional issues. For example, complexity abounds in the areas of ethics and law wherein some jurisdictions lack a legal definition of death, leading some religious groups to hold to their own definition of what death means whilst debating the use of a criterion such as neurological death to withhold donations to proceed. Jurisdictions vary in the use of "opt-in versus opt-out" consent processes when it comes to being a donor, as well as differences in the requisite "hands-off" time limit for concern over the return of spontaneous circulation to honor the dead donor rule. All of these are confounding factors at play in reviewing the current state of affairs when it comes to organ donation around the world- particularly as it relates to out-of-hospital cardiac arrest (OHCA) cases.
A successful organ donation and transplant system involve a complex interplay of many disparate moving parts: early identification of potential organ donor opportunities, premortem interventions, post mortem and pre-surgical organ support and care, successful donor registries, and public trust in the system to permit organ recovery, an effective and fair allocation process for recipient matching, safe and effective means to transport organs ex vivo, successful grafting and organ acceptance in the new host, as well as economic assessments, quality of life evaluation and continued follow-up and monitoring are needed. Each step is complicated by its own science, challenges, and system-level nuances.
It is under these circumstances that the Morrison, et al. scientific statement on Organ Donation after Out-of-Hospital Cardiac arrest provides a welcomed clear, and evidence-informed approach to removing barriers and optimizing the existing system to enable access to what may be an existent source of organs currently being underutilized.2
As presented in this statement, with an existing overall survival rate of about only 10% for OHCA patients, this could be reconsidered as representing a large number of potential donor organs as yet underutilized- basically a percentage of the remaining 90 % where resuscitation attempts were futile. As noted in this paper, the majority of these patients succumb to a circulatory death with or without ever regaining spontaneous circulation, or they regain circulation only to have life-sustaining therapy withdrawn secondary to severe neurological injury and a poor prognosis.
This scientific statement covers international data and practices, and considers the current practices behind all forms of potential organ donors from OHCA cases: Beating heart (brain dead) and non-beating heart donor (circulatory death). Though important to consider, statistically neurological death is considered an infrequent outcome in OHCA patients. Donation after circulatory death can happen in one of two sets of conditions: controlled (cDCD) or uncontrolled (uDCD). Strides are being made in recognizing cDCD opportunities given the ideal conditions and time allowances that can exist in preparing for a transplantation opportunity. uDCD on the other hand is logistically more complicated from an administrative and operational perspective, particularly when time and resources are the limiting factors.
In an attempt to redress this situation the scientific statement's recommendations can be placed into three basic categories:
System administrative upgrading and the use of evidence-informed standardization processes need to be put into place so that practices are recorded appropriately and consistently across geographical boundaries.
-Modify the Maastricht classification system to better reflect the realities and nuances in OHCA events
-Require organ donation information to become a normalized reporting outcome in both existing registries as well as any clinical trials involving resuscitation research. Modifying the Utstein template used in reporting cardiac arrest to enable identifying organ donation would assist in capturing this information.
-Standardize the "hands-off" time and criteria for the termination of resuscitation rule (TOR) will provide a consistent and transparent set of guidelines that can help bridge the patient to donor transition
Establishing a research and quality improvement initiative to remove barriers and improve opportunities that can support organ donation.
-Research to validate neuro prognosis tools to support clinical decision-making in the absence of brain death.
-As eCPR programs continue to evolve, opportunities to identify potential organ donation should be incorporated into their operating algorithm
-Publish validated algorithms and guidelines that incorporate considerations for organ donation as an integral part of OHCA
-Conduct quality improvement research into the practice of uDCD after OHCA such that the logistics and clinical obstacles can be addressed to better facilitate transitions of care to organ donation
The last, but potentially the most impactful recommendation from which all of the other recommendations could be maximized, involves setting social policy and laws enabling organ donation to be realized based on an opt-out versus opt-in requirement for citizens at the age of majority- 16 years old. The arguments for and evidence to support an opt-out system are compelling.
Evidence presented in this scientific statement, and echoed in the academic literature, identifies the positive outcomes reported in organ donation and transplantations in countries where policies enabling "opting out" for determining eligibility status as a potential donor are legally supported. Though limited in practice internationally, statistics reported from the US showed that 90% of Americans are believed to support organ donation but only 50% have signed up;3 this seems to identify a disconnect between thoughts and actions. This reality goes towards supporting the use of such a public health policy nudge as making organ donation the norm and opting out as an active choice better reflect what appears to be public opinion.4
However, implied consent from an opt-out system does not equate to consent as we legally and ethically understand it. It's based on an assumption that this wish is contemporaneous and that assent truly reflects the current wish of that individual. Public support and trust are essential components of all organ donation programs- particularly if presumed consent is to be based on an assumption of assent actually existing (i.e. particularly when this presumption is being technically supported by a lack of direct action by an individual).
It is recognized that valuable time is taken up in trying to find relatives in order to obtain consent for organ retrieval to proceed. In cases of uDCD time is of the essence in order to create an opportunity for a donation to exist. The authors rightly point to Spain as an example of what is possible. Since changing its law in 1979, to allow for opting out, they have consistently had the highest organ donation rate in the world—36 deceased organ donors per million people. But Spain emphasizes that its success is also based on building an organized, professionalized system that patients can trust.4
Trust in justice and fairness extends to the most delicate aspects of organ donation. Donors must be comfortable knowing that their wishes will be respected after death. Indeed, a truly sustainable future—where the expectation of gifting and receiving organs is normalized and valued by all in societies—can only happen with trust. A trust that goes beyond rational confidence in the efficiency or resourcing of a system, but one that also believes the system to be just and fair. Failing to recognize the importance of trust may limit these recommendations and new investments in our attempt to close the organ supply and demand gap.
An 8 to 1 ratio of potential beneficiaries of organ transplantation to actual donors belies the significant benefit and impact that increasing organ procurement can incur. This scientific statement provides an important road map to assist everyone in making the overall system better and more effective. To this end, it should be considered a valuable call to action.
Morrison LJ, Sandroni C, Grunau B, Parr M, Macneil F, Perkins GD, Aibiki M, Censullo E, Lin S, Neumar RW, Brooks SC; on behalf of the International Liaison Committee on Resuscitation. Organ donation after out-of-hospital cardiac arrest: a scientific statement from the International Liaison Committee on Resuscitation [published online ahead of print August 8, 2023]. Circulation. doi: 10.1161/CIR.0000000000001125
- Regalado A. The gene-edited pig heart given to a dying patient was infected with a pig virus. MIT Technology Review. Published: May 4, 2022. https://www.technologyreview.com/2022/05/04/1051725/xenotransplant-patient-died-received-heart-infected-with-pig-virus/
- Morrison L, Sandroni C, Grunau B, Parr M, Macneil F, Perkins GD, Aibiki M, Censullo E, Lin S, Neumar RW, Brooks SC. Organ Donation after Out-of-Hospital Caridac Arrest: Scientific Statement from the International Liaison Committee on Resuscitation.[Reviewed ahead of publication in Circulation, 2022]
- National Survey of Organ Donation Attitudes and Practices, 2019. https://www.organdonor.gov/sites/default/files/organ-donor/professional/grants-research/nsodap-organ-donation-survey-2019.pdf [Accessed Sept. 30, 2022]
- Organ donation depends on trust. Lancet. Editorial| Volume 387, ISSUE 10038, P2575, June 25, 2016. Published: June 25, 2016, DOI: https://doi.org/10.1016/S0140-6736(16)30886-8
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-- The opinions expressed in this commentary are not necessarily those of the editors or of the American Heart Association --