Speakers debate potential of opt-out system to help increase US organ donor rate
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Presumed consent, by which a country’s residents agree to donate their organs upon death unless they actively opt out, has the potential to improve the donor rate in the United States but raises supply-and-demand issues, speakers said.
“We know there is substantial variation in access to transplant steps. There [are] a lot of data to support that our current system really is grossly underestimating the population that is truly eligible for transplant,” Rachel E. Patzer, PhD, MPH, associate professor in the division of transplantation of the department of surgery at Emory University School of Medicine, said during the virtual American Transplant Congress.
“... (W)e really need a bold and compelling new model to improve equity and access to transplantation. And that bold, new model is really around advocating for this opt out for transplant referral model,” Patzer said.
But Lloyd Ratner, MD, director of renal and pancreatic transplantation in the department of surgery at Columbia University Medical Center, argued that an opt-out system will increase referrals for transplant without dramatically increasing the supply of donated organs to meet the greater demand.
“I think the opt-out system for transplant and referral is laudable but misguided,” he said in his debate with Patzer. “It’s likely to result in the poorest candidates utilizing more of our transplant resources. It is likely to prolong waiting times. It’s likely to create an unnecessary burden for transplant centers without the adequate compensation and financial support.”
Patzer said equity in the distribution of available organs in the U.S. is a major issue.
“Our metrics are flawed in this area and by looking at the referred population, [an opt-out system] would give us a better understanding of equity in all aspects of the transplant process, particularly those earlier steps in the transplant process,” she said. “Creating a default would improve access to information about the procedure and help to improve access among [patients with end-stage renal disease]. Providing that opportunity for transplant access is really our responsibility to the patient population.
“When given the variability we do know, this opt-out model could really have the greatest impact and really could improve equity by reducing some of our current biases in the system.”
How it works
One country, Spain, has an established opt-out system and has seen an increase in donated organs and transplant procedures performed. Other countries are developing similar programs, which also allow family members to object and withhold the donation.
In an opt-out system, patients would automatically be referred to a transplant center for evaluation if they meet basic eligibility criteria, Patzer said, “and ideally, this is happening in the first few months of end-stage renal disease, if not before. Ideally for these patients, it would be something that occurs even before dialysis starts.”
That might help reduce structural barriers associated with the current referral process and “lead to differences in the disproportionate timing in referral for transplant that we see across programs,” Patzer said.
Ratner said a major concern is the additional workload placed on transplant centers as referrals increase and the waitlist expands.
“In 2018, there were 131,000 new cases of end-stage renal disease and yet in 2018, almost 38,000 patients were listed for transplant. So that is about 30% of the total.
“The numbers went up again in 2019 in terms of number of patients being listed, but we don’t come anywhere close in meeting that demand,” Ratner said.
“The other thing we notice is that as we list more patients, the listing has exceeded the supply of organs and so the rate of transplant is going down, and that is driving up the waiting time. So, patients are waiting longer and if we had sort of an opt-out system for referring, we would expect the same thing to happen. We would get more and more patients put into the system, put on the list and decreasing the transplant rate and extending the waiting times.
Increase in referrals
Patzer acknowledged a number of potential problems with the system, agreeing with Ratner that the increased referrals would lead to a higher workload for transplant centers. Electronic medical record systems could improve workflow along with telemedicine “if programs can’t take on the burden of seeing that many patients in-person,” she said.
“There may be an opportunity for screening initially. We’ve seen, I think, in COVID that this is a reasonable approach to reduce workload compared to in-center visits for all those patients.”
Excessive referrals could also flood the waitlist, she acknowledged.
“Why would we want to flood the waiting list when we don’t have enough organ supply?” she said. “But I would have a few arguments to that. One, this is really about equity. So why shouldn’t we have the patients that are truly eligible for transplant ... be on a waiting list? We need to understand what the demand is for transplant to be able to come up with innovative solutions for how we might address some of these issues and problems later in our transplant process.
“But I think it starts here with identifying the appropriate candidates who are eligible for transplants and making sure this is an equitable process for doing so,” she said.
Ratner said the United States could bypass the opt-out system and increase organ donation by relying on nondirected donors.
“The ideal donor age, let’s say, is from 20 to 59 years old. There are 172 million people in the United States. So, we need 54,000 organs presently out of 172 million people — that would be about 0.03%, or about one in 3,000 or three in 10,000 people, who would have to come forward and donate an organ,” Ratner said. “I do not think this is unrealistic. “
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Patzer R. “Pro: An opt-out referral system for kidney transplant referral is the solution.”
Ratner L. “Con: An opt out system for kidney transplant referral will overwhelm transplant programs and without significant financial support will harm patients and transplantation.”
Presented at: American Transplant Congress; June 4-9, 2021. (Virtual meeting).
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