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Extended Donor Criteria for Transplantation:
Saving Lives by Increasing Alternatives

Extended Donor Criteria for Transplantation

In October, 2003, doctors told John Rice of Brooklyn that he had liver cancer, with tumors over five-and-a-half centimeters wide. He was not allowed on the liver transplant list with tumors so large. "I had two doctors who told me to get my life in order," Mr. Rice recalls. "I was given three months to live."

But Mr. Rice didn't give up. He searched the Internet and discovered liver surgeon John F. Renz, MD, PhD, an Assistant Professor of Surgery at Columbia University College of Physicians and Surgeons. Mr. Rice learned that he did indeed qualify for a liver transplant with Dr. Renz, thanks to surgeons at NewYork-Presbyterian/Columbia utilizing organs that don't meet the usual criteria for the procedure, but are still healthy enough for a successful transplant. "Dr. Renz told me I had a 100 percent chance of dying without the transplant," says Mr. Rice, 53, who celebrated his one-year transplant anniversary with a trip to Florida, where he walked for hours around Disney World.

Due to a significant shortage in available organs, scores of people die before receiving a liver, lung, heart, or kidney off the transplant waiting list. In New York State there are eight patients on the waiting list for every available liver. In addition, many patients are considered too sick or too old to even get a place on the list. But at NewYork-Presbyterian/Columbia, surgeons have saved many lives by reducing the stringent criteria for donor organs, or by increasing the age at which patients can receive a transplant.

Since 2000, when some NewYork-Presbyterian/Columbia surgeons began utilizing these Extended Donor Criteria (EDC) organs, survival has ranged from being equal to the outcomes of patients receiving regular organs to, in the case of heart transplants, a one-year survival rate that is slightly lower: 90 percent of patients who receive standard hearts survive, but that number drops to 75 to 80 percent when patients receive an EDC heart.

Hearts

Heart Transplant

"Yet the alternative heart transplant still gives them much better survival overall," says Yoshifumi Naka, MD, PhD, Director, Cardiac Transplantation Program. "With end-stage heart disease, the one-year survival rate is less than 25 percent without a transplant." In fact, most of the alternative heart recipients die not from the donated heart, but from underlying medical problems.

With heart patients, the criteria have extended not only for the selection of the donor heart, but for the choice of recipients. Patients older than 65 can now receive a heart transplant with an EDC organ. "We don't want to use a 65-year-old donor heart for a young recipient," Dr. Naka explains. "Now, a 70-year-old could receive an older heart that seems to be in good condition, or even a young heart that is a little dysfunctional."

Livers

Due to the great shortage of livers for New Yorkers, patients in this state must wait longer for an available organ than people in other parts of the country. A longer wait means becoming sicker. "About half the people waiting for a liver will die if they continue waiting," says Dr. Renz. "So the key is to get a liver sooner."

One answer is to obtain livers that don't meet the traditional acceptance criteria from areas of the country with a surplus. This includes donors with a history of hepatitis B or hepatitis C, or donors with active use of IV narcotics until their death.

Mr. Rice does not know what was wrong with his donor, but he doesn't care. "Without a doubt Dr. Renz saved my life," says Mr. Rice, noting that he feels 30 again. "No one else would have taken me because I didn't fit their criteria."

EDC livers go to patients who are not as sick as those who receive livers that meet the traditional standards. "EDC recipients accept a slightly higher incidence of a complication or risk of a donor-transmitted disease, because that's why the organs were not used in a surplus area to begin with," says Dr. Renz. "In return, they lower their chances of getting sick or dying while on the waiting list for a non-EDC liver."

The outcomes of liver transplants using extended donor criteria are similar to those with regular transplants. At one year, regular liver recipient have an 84 percent survival rate, while the survival rate for EDC patients is 83 percent. At three years the survival rates are equal at 76 percent.

Kidneys

Physicians at the Renal and Pancreatic Transplantation Program of New York-Presbyterian/Columbia have looked outside the box for solutions to the kidney shortage. In 2004, Lloyd E. Ratner, MD, the program director, performed the hospital's first kidney swap, which involves taking patients who have healthy potential donors but are blood group incompatible, and swapping donors so that donors are now matched with compatible recipients.

For example, one patient needed a kidney transplant and was blood group B. His sister, who wanted to donate to him, was blood group A. Another patient had blood group A, but her step-mother, who wished to donate to her, was blood group B.

"We basically swapped donors," says Dr. Ratner. "To make sure that no one backs out once their loved one gets a kidney, both donors have to undergo anesthesia and have the surgery at the same time. We need four surgical teams and four operating rooms. The logistics need to be synchronized perfectly." Anonymity is kept between the swapping participants prior to surgery.

Another alternative is transplanting incompatible live donors if a compatible live donor cannot be found. To accept a kidney from an incompatible donor, the recipient's blood must be repeatedly "cleaned" of mismatched antibodies through a process known as plasmapheresis. "Our goal is to make optimal use of live donors, getting people off the transplant waiting-list and back to their normal productive lives," Dr. Ratner reports.

Lungs

Lung transplants involve just one list of available organs and one set of patients. "Traditionally, the criteria to accept lungs for donation has been stringent because operative results have been suboptimal," says Joshua R. Sonett, MD, Director, Lung Transplant Program. "Since there is a donor shortage, we've been aggressive in trying to see which lungs we could use from the pool of lungs that would have been rejected by other centers. According to traditional criteria, a lung might be sub par, but we don't think so."

His program's survival rates prove it. Dr. Sonett says that between 2001 and 2003, 53 percent of the lungs transplanted at NewYork-Presbyterian/Columbia were extended donor criteria lungs, with no difference in survival between EDC lung recipients and regular lung recipients. Dr. Sonett's program has a 90 percent survival rate after one year—far above the national average of 78 percent.

"We had a young girl on the transplant list who was going to die relatively soon," says Dr. Sonett. "We matched her with a EDC lung from a donor with a long history of brain cancer and now she's doing excellent."

Dr. Sonett expects his program will perform over 40 lung transplants this year. Despite using extended criteria—including some donors with a minor smoking history—between 10 and 30 percent of patients die annually while waiting for a lung.

Mr. Rice was one of the lucky ones. "As you can imagine, there are no words I can say," he says. "We're talking about a very grateful family."


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