Cardiac Transplant in Midst of ‘Revolution,’ but Public Trust Is Fragile

At a time when registered organ donors are taking their names off registration lists, with a spike in such moves this past summer after several mistakes made national news, there is an urgent need to reestablish confidence in the US transplantation process, say experts.

The transplantation field has had its reputation sullied by reports of “rushed or premature attempts” to remove organs, stories of pressure on families to authorize a donation or on hospital staff to remove life support, and instances in which some patients on waiting lists have been skipped to expedite and ensure organ placement.

Maryjane Farr, MD (UT Southwestern Medical Center, Dallas, TX), said the exodus from organ donor registries—one nonprofit group managing a national registry reported a 700% increase in donor removals since July—is “absolutely devastating” because it means that people have lost faith in the system.  

“In the 50 years of [heart] transplant, it has a place in society for offering a gift of life,” she told TCTMD. “It remains unique as it’s a medical and surgical therapy that can only be had based on the humanitarianism of others. There’s no other way to do it.”  

Trust in the system remains the “absolute lifeblood of transplantation” and it’s something that no one in the field ever wants to see damaged, said Mandeep R. Mehra, MD (Mass General Brigham, Boston, MA). “It’s the thing that gives people hope and families a reason to be altruistic,” he told TCTMD. “If there’s any violation of the trust, it starts to disease the system in very important ways.”

Sean Pinney, MD (Icahn School of Medicine at Mount Sinai, New York, NY), another advanced heart failure and transplant expert, said the public’s recent perception of the transplantation process has been extremely concerning, specifically because the gift of organ donation is considered “sacrosanct” by transplant physicians.

“Nothing is more concerning for those of us who work in transplant than losing the public trust,” he told TCTMD. “Without it, all of transplant goes away because what we are asking donor families to do is extraordinary and it’s heroic and it is based on a fundamental trust: trust in the system and trust in the providers that we are going to do everything in our power to recognize the profound nature of their gift.”

Ethical Concerns of DCD

The first heart transplantation was performed in 1967 in South Africa by Christiaan Barnard, MD, at Groote Schuur Hospital, and this was followed by Norman Shumway, MD, PhD, who completed the first US human heart transplant at Stanford University School of Medicine in 1968.

There has always been a shortage of donor hearts, with fewer than 6,000 heart transplantations performed each year. Today, there are roughly 3,500 patients on the waiting list. In the past, organs had been recovered after brain death, but introduction of donation after circulatory death (DCD) has dramatically altered the field, with some estimates that DCD increases the number of available hearts for transplantation by 30%. The first DCD heart transplantation in the United States took place at Duke University Hospital in 2019, but the procedure was performed previously in Australia in 2014 and the United Kingdom in 2015.

“The brain death definition has always been our standard,” said Farr. “[DCD] is an absolutely new era.”

There are two ways to recover the donor heart. With ex vivo organ perfusion systems, the heart is removed and placed on a machine to preserve and perfuse it during transport. In normothermic regional perfusion (NRP), which was developed to improve the quality of organs taken after DCD, the aorta is clamped and the heart is perfused within the donor, a process that allows its function to be assessed before it is removed.

It remains unique as it’s a medical and surgical therapy that can only be had based on the humanitarianism of others. Maryjane Farr

For Pinney, those in the cardiac transplantation world are “living in the middle of a revolution” with DCD. However, it has not been without ethical concerns, chief among the definition and determination of death. Before the heart or other organs are removed, “it must be determined beyond any doubt that the donor has no future potential for life,” according to a position statement from the International Society for Heart and Lung Transplantation.

In the media this year, there was a case in which surgeons discovered a heart still beating after the patient had been declared dead as well as others, including a high-profile report about a Kentucky man, where patients seemed to regain consciousness despite preparations for donation.

Pinney said taking one’s name off a donor list is an “understandable reaction” in response to some of these horrifying reports. Farr agreed, noting in a recent editorial that these highly publicized cases of donors showing awareness prior to procurement have “seeded doubt in the public and, at times, health professionals alike.”

There have also been troubling reports that some federally-funded organ procurement organizations (OPOs)—the 55 nonprofit organizations that facilitate the donation process by working with donor hospitals to place organs for transplant—“aggressively” pursued circulatory death donors and pushed their families toward surgery for the available organs.

In September, the US Department of Health and Human Services (HHS) decertified an OPO affiliated with the University of Miami Health System following an investigation that detailed unsafe practices and staffing shortages that led to missed organ recoveries. In July, an investigation from the Health Resources and Services Administration, an agency of the HHS, found problems with another OPO, this one serving Kentucky, southwest Ohio, and part of West Virginia. That case involved some patients who “may not have been deceased at the time of organ procurement” and others who had neurological signs incompatible with donation.  

Reactive, Not Proactive

The Centers for Medicare & Medicaid Services (CMS), which oversees OPOs, established performance thresholds in 2021 as part of conditions for coverage, with the organizations at risk of decertification if their donation or organ transplantation rates flag. The performance metrics have been criticized as flawed, with some of the OPOs arguing that aspects of the transplant process are out of their control, such as the nonuse of organs by transplant centers.

This has led to reports that the government pressure to place more organs has some OPOs skipping patients on the transplant list in favor of “ease over fairness,” according to an article in the New York Times.

“There’s been a lot of scrutiny of organ procurement organizations, that they’re underperforming, and so new federal guidelines have held them to very high standards,” said Farr. “As a result of that, organ procurement organizations are increasingly stressed to increase the volume and efficiency of organ placement.”

Pinney noted that the government’s performance metrics have unintended consequences, including out-of-sequence allocation.   

“Maybe you are number five on the list, for example,” said Pinney. “If that center is taking too long to make up their mind, or maybe the person needs a crossmatch test [for compatibility], but another hospital says we have someone who’s number 40 on the list, and if you give us the organ, we’ll take it right now, they allocate the organ out of sequence.”

If there’s any violation of the trust, it starts to dismantle the system in very important ways. Mandeep Mehra

Such queue jumping happened in the past, but it was very rare. However, since the introduction of the 2021 CMS outcomes measures, out-of-sequence allocation for kidney transplants jumped 20%. Similarly, out-of-sequence allocations of donor livers, lungs, and hearts increased 15%, 8%, and 3%, respectively.

“What you see in real time is cause and effect,” said Pinney. “Some of this behavior is the direct consequence of the regulations that [HHS] put in front of the OPOs. It’s reactive rather than proactive.  Whenever you have scorecards, whenever you have threats of closure, that’s going to change behavior and sometimes not always for the best.”

Farr agreed, calling the expedited placements a “rational response to performance metrics.” The OPOs are incentivized to expedite organ donation at hospitals with a greater willingness to take them, which is critical in cardiac transplantation because of the need to avoid prolonged ischemic time.

In the past, declaration of brain death took longer, but now if a patient arrives at the hospital with a devastating neurologic injury and the family is given information that they are very unlikely to recover, the discussion around donation gets started before the donor is deceased. Farr stressed that the declaration of death rests with the treating physician and OPOs are being unfairly disparaged for some of these high-profile mistakes.  

“[The OPO transplant coordinators] are working with this family day in and day out, and so they’re providing a lot of information and explaining a lot of the details,” said Farr. While there can be variability in the quality of the interaction, transplant coordinators are “wonderful people who have devoted their lives to the delivery of safe and secure transplantation in the United States—we absolutely can’t live without them.” 

Adverse Incentives

While some cracks have been exposed in the foundation, Mehra said the US continues to deliver world-leading transplantation outcomes. These discovered fissures undoubtedly have consequences, including the removal of names from the donor registration list, but Mehra is confident that the US transplantation field will address the problems. 

“Are there variabilities in organ procurement? Yes. Is there some inconsistency in DCD practices in the US? Yes. Are there rare cases where death has been declared when in fact the patient was still aware? Yes. Are there policies in play right now that reward speed over fairness? Yes,” said Mehra. “Confronting these issues is critical, but the solution is not to dismantle the system. What we need to do is modernize it.”

For example, he noted that states vary in their use of NRP. In Massachusetts, NRP violates the “dead donor rule” and is not allowed, but it is acceptable in Pennsylvania and Tennessee. Even within states, some centers allow use of NRP and others do not. “Can we ethically reconcile this as a national standard?” asked Mehra. “Right now, we don’t do that.”  

Another way to bring the system in line is through greater transparency around the performance of the OPOs, he said. The development of national standards for the organizations is warranted, including how to communicate with families, but there’s also a need for changes to the performance metrics that reward speed over fairness and appropriate dialogue.

“Some of the national policies are related to the adjudication of speed—how quickly can you get things moving?—and they potentially create adverse incentives,” said Mehra.

What you see in real time is cause and effect. Sean Pinney

Farr notes in her recent editorial that there is a need for increased transparency from OPOs and transplant centers around their outcomes and policymaking processes. What’s also needed are guidelines or consensus documents around the roles of those involved in the care of the donor, such as the roles of anesthesiologists, surgeons, medical teams, and more.

“Different hospitals will do different things with a DCD transplant,” said Farr. For example, anesthesiologists at one hospital may be comfortable and skilled in transplant medicine and will provide appropriate anesthesia to relieve pain and suffering. Others may have fundamental concerns about DCD and worry about providing sedation to those who are not brain dead, or about facilitating that death, she said.

“It can be very, very complicated,” said Farr. Factor in the different ways of performing DCD, specifically with normothermic regional perfusion, and things can get quite murky, she added. “What should not be forgotten, however, is that transplant professionals—surgeons, physicians, nurses, coordinators, logistical specialists, and administrators—devote their lives to honoring the gift of life [and] to safely and transparently offering organ transplant to the hundreds of thousands of children and adults in the United States dying of organ failure,” Farr said.