News and issues that affect organ and tissue transplantation

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UNOS plans to roll out a national paired kidney donation program, but combining existing programs may be difficult In September, the United Network for Organ Sharing (UNOS) will roll out a pilot national kidney paired donation (KPD) program, with plans to go live in the fourth quarter of 2010. For the most part, everyone is excited. “I think a national KPD program administered by UNOS will provide the largest growth in live donation that this country has seen in the last decade,” says Dorry Segev, MD, PhD, director of clinical research for the Transplant Surgery Division at Johns Hopkins University in Baltimore. Ruthanne Hanto, RN, MPH, clinical program manager with the New England Program for Kidney Exchange (NEPKE) agrees. “UNOS will ultimately be best equipped to accomplish a national system,” she says. Some have estimated the potential increase in live kidney transplants at more than 2,000 a year with a national program. However, there are those who point out the huge logistical difficulties, not the least of which is bringing together the various consortia already offering KPD programs across the U.S. “We could continue to have disjointed consortia throughout the country, but it won’t yield the optimal number of transplants,” says Robert Montgomery, MD, DPhil, director of the Johns Hopkins Comprehensive Transplant Center. Perhaps you’ve heard the expression “trying to herd cats.” Like herding cats, coordinating these groups could be a challenge. The UNOS pilot program will start small, with two to four participating groups that have KPD experience. The number of donor/recipient pairs will be limited to three (see Figure 1) so that logistical difficulties can be worked out. A UNOS coordinator will facilitate organ procurement organization (OPO) and transplant center activity to determine the need for centralized coordination. Additionally, the pilot program will look at the complicated issues surrounding Medicare and/or insurance reimbursement. For example, who will pay for a donor work-up at one center for an organ that is shipped to another center? As UNOS gears up for the national program, it is seeking funding from private foundations to help offset costs. “If we can obtain enough funding, we may be able to offer assistance to needy candidates and donors,” says Kenneth Andreoni, MD, associate professor of surgery at Ohio State University in Columbus and chair of the UNOS KPD subcommittee. This summer, UNOS sought public comment on whether the pilot program should also incorporate open and closed chains that take advantage of nondirected altruistic donors. The chain concept has the potential to create nonsimultaneous, extended chains of live donation. However, the logistics are considerably tougher than with twoor three-way paired donation. If responses to the UNOS request are positive, in November the Kidney Committee will recommend to the Board that the chain concept be incorporated in the pilot program late this year or early next year. Although first proposed in 1986, the concept of paired donation was held up for several years, beacause transplant professionals feared it might be construed as “valuable consideration” under the National Organ Transplant Act (NOTA). Even before that issue was resolved with the Norwood Act, Johns Hopkins began paired donations, followed shortly by groups in Ohio and New England. Before long, paired donation programs began at single centers and in groups around the country. One of the original pioneers, the University of Toledo's Michael Rees, MD, PhD, now heads the Alliance for Paired Donation. He too is excited about a national program, but worries that “we’re not ready for a pilot program run by UNOS,” which he believes lacks the nimbleness and innovation required in the complicated arena of paired donation. “There are six competing paired donation systems right now doing things in differing ways. I think we can learn a lot from those programs and UNOS can incorporate what is best to build a national system,” he says. According to Dr. Andreoni, many of the existing programs are relatively similar and computer issues won’t be a problem. The pilot program has adopted the best computer optimization programs (including those from Johns Hopkins, Carnegie Mellon and NEPKE), and will incorporate the operational guidelines used by these groups. Hanto believes the biggest challenge will be the coordination of transplants among participating centers. Dr. Rees agrees. “The process of coordinating transplants is a much larger issue than building the software to identify those transplants in the first place,” he says. Ron Shapiro, MD, president of the Paired Donation Network and professor of surgery at the University of Pittsburgh, says the ideal solution would be to have a single national program. “The question is, how do you get there?” he asks. Another consortium leader, Garet Hill of the National Kidney Registry, also supports the goal of a national system, but believes the ideal program must address the problem of incomplete antibody and antigen identification that exists in the current deceased donor system. He says the incomplete information is currently causing numerous live cross-match failures that slow down the paired exchange process. “The system must also address the inevitable issue of out-of-balance pools,” he adds, pointing out the need to attract compatible pairs who are willing to participate in KPD to obtain a better antigen match. “With the shortage of A blood-type recipients in KPD, bringing in compatible pairs will rebalance the pool so that greater than 95% of the pairs can find a match within six months.” Meanwhile, at Johns Hopkins, protocols have been developed to expand the usage of KPD. “At Johns Hopkins, we’ve basically matched everybody in our pool who is matchable. The way our pool looks now is the way a national pool will look in three to four years,” says Dr. Segev. What Hopkins did was to develop a protocol using compatible but poorly matched pairs.1 The team also took advantage of nondirected altruistic donor chains and developed a method to combine desensitization with KPD. “A big part was figuring out the phenotypes,” says Dr. Montgomery. “A lot of the match work was first done in simulations to determine which phenotypes would be better to desensitize and which should go straight to KPD.” Now instituted, the Hopkins’ protocol puts easy-to-match patients into the KPD pool and easy-to-desensitize recipients into the sensitization tract. “I think the thing to realize about this field is that there’s not one thing that can solve the problem,” says Dr. Montgomery. “It’s going to be a combination of these different modalities.” Dr. Andreoni notes that the pilot program will start off slowly, develop a firm foundation and then move forward with possible future considerations such as use of compatible pairs trading up and desensitization combined with KPD. He predicts this will happen in three to five years. The Netherlands has discussed its tremendous success with a five-year-old national paired kidney donation program.2 According to Marry de Klerk from Erasmus Medical Center, Rotterdam, “to supervise a national program, it is important to have one independent organization … to ensure that matching will take place in a fair and neutral way.” She also advocates a national coordinator and a centralized HLA laboratory. However, “the biggest challenge for other countries will be the choice of a national HLA reference laboratory to perform all the cross-matches between the new donor and the recipient,” she says. “In the Netherlands, we already had our HLA reference laboratory for our cadaveric kidney transplantation program.” In a presentation at the annual meeting of The International Society for Heart & Lung Transplantation (ISHLT) last spring in Paris, Johns Hopkins transplant surgeons reported that having both lungs replaced instead of just one is the single most important feature determining who lives longest after having a lung transplant. The finding is potentially controversial. Edward Garrity, MD, MBA, professor of medicine at the University of Chicago, says, “I agree with the philosophy of double-lung transplants as a rule, but the analysis takes what is in the database and analyzes that information. Thus it appears there is no real mention of age as it relates to choice of operation. Many believe older patients have a more difficult time with double-lung transplants.” Noting that the Hopkins’ findings aren’t new, Stuart C. Sweet, MD, medical director of the Pediatric Lung Transplant Program at Washington University in St. Louis, says the ISHLT registry reports have shown similar information. “The decision between offering single- and double-lung transplant is more complicated than just whether the likelihood of 10-year survival after transplant is greater,” he says. “For example, the time waiting for transplant may be longer for a patient waiting for a double-lung transplant than a single lung transplant.”