Oct. 30, 2018 -- Dennis Blough had been on the waiting list for more than 2 years when the call came. His surgeon at the University of Southern California in Los Angeles had a heart ready for transplant. But the good news came with a caveat: The heart was from an ''increased-risk'' donor.
His doctor explained that an organ classified as increased risk simply means the donor had certain characteristics, such as drug use, that could make the recipient more likely to get a disease, but not that the organ is in any way inferior.
The potential donor had had syphilis. But Blough's doctor reassured him that if he got the sexually transmitted infection, it was easily treatable with antibiotics. Blough and his wife, Loree, discussed the offer. "I had some mild misgivings," says Blough, now 62, of Laguna Hills, CA. But he decided to go ahead.
As it turned out, he didn’t get that heart after doctors discovered he was still on some medications that must be stopped for a period before the transplant. Six months later, in January 2017, he got another heart and is doing well.
Even so, Blough says he would advise people to consider these organs -- to weigh the time they've been on the list against the risk involved with the donor organ being offered.
Increased-Risk Hearts -- and Survival
That perspective is a good one, many experts agree. Accepting the increased-risk organ may mean a better chance at survival, according to the results of a new study published Monday. Researchers found that accepting a heart from an increased-risk donor resulted in a higher 1-year survival rate for patients than declining that offer and waiting for a different organ. As they waited, some who declined the increased-risk organ died or became too sick to have a transplant, the researchers report.
"Accepting an increased-risk donor organ for transplant is an excellent way to get a heart transplant more quickly, and that makes a real difference in their outcomes," says Michael Mulvihill, MD, a research fellow in surgery at Duke University Medical Center in Durham, NC, and the study's lead author. Those who accepted the offer were not only more likely to survive at the 1-year mark, he says, but the survival benefit continued for 5 years.
But Duke’s researchers did not look at how common it is for a donor organ to pass along disease to its new host. The United Network for Organ Sharing (UNOS), which administers the federal Organ Procurement and Transplantation Network that Congress created in 1984, says it doesn’t have specifics about the odds of getting a disease from an increased-risk organ.
In another study published in 2017, researchers tracked the health of 257 adult organ recipients of organs from donors that were either high risk or increased risk. They found 9 patients tested positive for either HIV, hepatitis B or hepatitis C with blood tests but all tested negative in testing and retesting by the more accurate nucleic acid testing. The researchers concluded that the blood tests were probably false positives.
Transplant Need and Increased Risk, Defined
With more than 114,000 people in the United States waiting for organ transplants, many experts say the time has come to give these ''increased-risk" organs a second look and to encourage patients and doctors to rethink the stigma surrounding them. Other researchers have found similar survival benefits with increased-risk organs.
About 25% of U.S. donor organs are now classified as increased risk, due to new guidelines and other things such as the opioid epidemic, says David Klassen, MD, chief medical officer for UNOS.
The term ''increased-risk organ” was coined in 2013, when the U.S. Public Health Service published new guidelines for cutting the transmission of HIV, hepatitis B, and hepatitis C during organ transplantation. Under previous guidelines from 1994, the term used was “high risk.” In the current guidelines, the Public Health Service emphasizes that the term doesn’t refer to organ quality, nor does it predict the survival of the transplant.
Among the things about donors that play into whether an organ is called increased risk are men who have had sex with men in the past 12 months, drug users who have injected for nonmedical reasons in the past 12 months, women who have had sex with a man who has a history of having sex with men, people who exchanged money or drugs for sex, those who have been in jail longer than 72 hours, and those treated for or newly diagnosed with sexually transmitted infections.
The new criteria are so broad, says Klassen, that ''the issue is how big is that risk? And in reality, that risk is really, really small."
Better Screening, Better Treatments
Better testing methods help cut the chance of spreading disease, Klassen says. While transplant centers cannot offer an organ with HIV, they can offer those with hepatitis B and C. Drugs for hepatitis C can cure it and hepatitis B is treatable
Testing donors for diseases is more accurate today, he says.
"The technology of screening of all donors has really advanced," Klassen says. Because the testing for such diseases as hepatitis C and HIV is more advanced, it's less likely that diseases will go undetected, he explains.
UNOS doesn't keep track of how many of the 254 transplant centers and 58 organ procurement organizations accept increased-risk organs and which do not.
A patient must consent to such an organ. As the percentage of organs termed increased risk rises, research is ongoing about the results. The Public Health Service has worked to help organ procurement organizations and transplant hospitals understand the risk.
'Post-transplant graft and patient survival with increased-risk organs is equal to or better than that with non-indddcreased-risk organs, the organization said in 2017
Heart Study Details
That was the finding in the Duke study. The researchers analyzed the impact of declining an increased-risk donor heart, tracking the results of more than 2,600 such organs offered to more than 10,000 transplant candidates from 2007 to 2017. Survival was better among those who got the increased-risk organ, compared with those who waited.
Of those who declined the increased-risk heart, 58% had a non-increased-risk organ transplanted, more than 12% later had a transplant with an increased-risk heart, and nearly 8% were taken off the list due to death or complications making them unsuitable for a transplant. And 21% were still waiting a year after the initial offer of an increased-risk organ.
Despite the good survival with increased-risk organs, the label still has a stigma, experts say. And the label of ''increased risk'' results in an estimated 313 fewer transplants performed each year, according to a model developed by researchers from UNOS, Loma Linda University, and other institutions. As of late October, 27,281 transplants have been done this year in the United States. On average, 20 people a day die while waiting, UNOS says.
The Duke study on heart transplant survival with increased-risk donors ''quantified something we have suspected for a while," says Mandeep Mehra, MD, medical director of the Heart and Vascular Center at Brigham & Women's Hospital in Boston and professor of medicine at Harvard Medical School, who commented on the study findings. "These hearts we decline due to perceived increased risk are perfectly fine hearts." He points out, too, that if donors had hepatitis C, they may have taken medication and already been cured. "The biases may be doing more harm in the timely allocation of organs to patients," he says.
What is needed is a mindset shift, agrees Jon Kobashigawa, MD, director of the heart transplant program at the Smidt Heart Institute at Cedars-Sinai Medical Center in Los Angeles. His center performs more than 100 heart transplants a year, on average, and he says his staff has adopted a new attitude about the increased-risk organs: "We don't think of it as taking risks; we think of it as saving lives."
Part of the reluctance on the part of the patients, Kobashigawa says, is that people may not truly understand what the term “increased risk” means -- that it describes things about the donor but not the donated organ.
Attitudes about transplanting the increased-risk organs tend to be different outside the U.S., experts say. A new study, presented at the American Society of Nephrology meeting last week, suggests that a more lenient attitude in the U.S. might lower the number of people on the kidney transplant waiting list.
Researchers from the University of Pennsylvania collaborated with researchers from France. They compared kidney quality and outcomes between the U.S. and France, looking at the UNOS registry and the Paris Transplant Group data from 2004 to 2014. French doctors accepted older patients, in general, and organs from less healthy donors. Many of the kidneys transplanted in France would have probably been discarded in the U.S. system, the researchers concluded.
Advice for Potential Recipients
Kobashigawa tells patients they should know there’s always a risk of not having a good outcome, whatever risk of disease transmission comes with the offered organ. ''There is no guarantee that even a standard donor is going to work," he says. "The 1-year overall survival for heart transplants is about 90%," he says. "That means 10% do not make it," even with donor hearts classified as the healthiest.
Patients tend to focus on infection risk, he finds. "When you are a patient and you hear you might get an infection from this donor, you get a little concerned." He tells patients that ''the risk of getting an infection from these donor hearts is very small." And, he emphasizes that ''we save these increased-risk organs for the urgent patients, where the benefits clearly outweigh the risks." He tells patients who do accept an increased-risk organ that they will be followed closely to look for infections or other issues.
"We are not using enough donor hearts," says Kobashigawa. "That's why this paper [from Duke] is so timely. It points out we can use more donor hearts and therefore save people."
Patients should discuss their feelings about the increased-risk organs with their doctors from the start, Mehra says. They need to weigh the pros and cons. And they need to understand if they decline the organs, another one may not be offered for a long time. "They may become sicker or may die. It's a chess game to a large extent."