The AJT Report News and issues that affect organ and tissue transplantation

Authors

  • SUE PONDROM


Abstract

Will the national Kidney Paired Donation program succeed? This month, “The AJT Report” takes a look at some of the advantages and potential drawbacks to the OPTN/UNOS pilot program. Also this month, we review updates from the Department of Health and Human Services regarding the Final Rule.

Will the National Paired Donation Program Take Off?

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[ Growth in nonbiological, unrelated paired exchanges (2000-2010). SOURCE: OPTN/UNOS]

Since its origins as a proposal in 2008, the Organ Procurement and Transplantation Network/United Network for Organ Sharing (OPTN/UNOS) Kidney Paired Donation (KPD) pilot program has matured to the point that a sophisticated computer system is due by year's end. Subcommittees are currently developing a strategic plan to determine how to best handle positive crossmatches, and are creating financial agreements for future participating centers.

Under the pilot program so far, transplant recipients have received assistance from four coordinating centers: the Alliance for Paired Donation, Johns Hopkins Hospital in Baltimore, the University of California, Los Angeles/California Pacific Medical Center and the New England Program for Kidney Exchange. This fall, Ruthanne Hanto, RN, MPH, program manager of the KPD program, met with transplant coordinators and physicians at eight of the 11 regional UNOS meetings to describe the national program and the upcoming opportunity for their centers to participate when the first phase of automation is completed. “This will allow for a gradual phase-out of the four coordinating centers,” says Hanto.

Michael Rees, MD, PhD, CEO of the Alliance for Paired Donation and director of renal transplantation at Ohio's University of Toledo Medical Center, agrees that there should be one national system. “It makes sense for UNOS to oversee and determine the allocation rules for incompatible living-donor kidneys. What a lot of people don't understand is what the overall system will eventually look like,” he says.

Dr. Rees also notes that “UNOS and their participating transplant centers alone do not achieve successful deceased-donor transplants. It takes payers and OPOs [organ procurement organizations] as well. In the end, KPD will require integration and coordination from outside entities such as OPOs, payers or other KPD coordinating groups with proven success.”

While it's a complicated process, Hanto says others can be trained to run it. “In some respects it will be easier for communication when only one organization is coordinating rather than four,” she adds.

Dr. Rees is also concerned that large paired-donation programs will send only their difficult-to-match recipients to the national program, keeping easier-to-match patients within their programs (which, according to Hanto, is what's happening now). “For a national program to work,” says Dr. Rees, “everybody has to figure out how to play fairly and together … If we could truly come together as one, we would have the best paired-donation program in the world. The problem is that UNOS by definition leads by consensus; consensus is not the way to achieve innovation, and KPD still requires innovation.”

KEY POINTS

  • • The OPTN/UNOS national Kidney Paired Donation pilot program is preparing to open up to more transplant centers.
  • • Among the advantages of the national program are a wide donor pool, a heterogeneous population and a sophisticated software program.
  • • Some transplant specialists have concerns about participating in the national program, specifically with regard to longer wait times to transplant, increased costs and uncertainties regarding the administrative burden of large programs.
  • • Optimal management of the expense and timing of the donor evaluation remains unresolved.

A Successful Single-Center Program Perspective

In San Antonio, the Texas Transplant Institute at Methodist Specialty and Transplant Hospital reports that it's done more paired kidney transplants than any other program. According to Adam Bingaman, MD, PhD, transplant surgeon and director of the institute's KPD program, the success of his program is based on six factors:

  • 1A large database of incompatible pairs (he says a critical mass of recipients is 100, and they currently have about 200 in their database1);
  • 2A sophisticated immunology lab;
  • 3Very close coordination between the clinical team and the HLA lab;
  • 4A sophisticated software program;
  • 5Desensitization of some patients; and
  • 6Use of compatible pairs.

Does the Texas Transplant Institute plan to participate in the national program?“We’ve talked about it,” says Dr. Bingaman. “I see advantages and disadvantages.” Among the advantages he notes are a bigger donor pool, which is key for smaller transplant programs; a more heterogeneous population (in San Antonio, his donor pool is largely Hispanic); and a highly sophisticated software program.

However, Dr. Bingaman sees disadvantages related to a national program's slower tempo, lengthy evaluation time and transplant-center expenses. “Of the 150 paired donor transplants we’ve done over the past three-and-a-half years, our median time from incompatible results until time of transplant was four-and-a-half months,” he says. “National programs can't work that quickly.” Furthermore, the national program requires that recipient and donor evaluations be complete before they are entered into the database. Dr. Bingaman puts consented pairs into his program “when they hit the door and I know whether they are favorable or not.” A full workup is done when a recipient is identified. “What happens in a national system,” he says, “is that a lot of donors never get put into the computer system because it is so unlikely that a recipient will ever have a match.”

Additional Goals of the National KPD Program

The national program is working on processes to decrease the time from offer to transplant, says Hanto. The program has established points for certain categories of matches, such as highly sensitized patients, prior donors, pediatric candidates and matches found within a region or donation service area (to decrease cold ischemic time).

Regarding expenses, the national program's finance subcommittee has a template developed and is working with legal counsel to put together a business associate agreement (which includes insurance information) so participating centers need only fill out the agreement once to be available for future matches.

Additionally, the program doesn't expect to see a problem with donors who might renege. “We’ve made the decision that donors won't donate until their recipients have gotten their kidney in a chain,” says Hanto. “We don't want a donor giving up a kidney while the recipient is left waiting.”

In the meantime, Dr. Bingaman says, “It's important for the transplant community to encourage every program doing live-donor transplants to participate in a program, whether that's as a single center, a regional program or a national program. We don't yet know what's best, but I believe everybody should participate in something.”

How Big Should a Chain Be?

At the Texas Transplant Institute, Adam Bingaman, MD, PhD, says his longest chain to date is 23 recipients, and it's still ongoing with an O-bridge donor. “We’re all doing open-ended chains,” says Michael Rees, MD, PhD, director of the Alliance for Paired Donation. Without nonsimultaneous extended altruistic donor chains, it forces a paired transplant program “to find one solution and then whatever they find, that's what they’re stuck with forever,” he says.

Dorry Segev, MD, PhD, director of clinical research for the transplant surgery division at Johns Hopkins Hospital in Baltimore, says, “In the real world, chains cannot go on indefinitely. They will hit a wall either because someone drops out, competing chains are looking to match similar bridge donors or they reach a hard-to-match bridge donor like an AB donor. All of these problems are already happening, and people are starting to reconsider how long they want to keep their chains going.”

He adds that it's hard to predict when a chain will hit a wall, so limiting the length of the chain itself is probably unwise. “A reasonable solution is to limit the amount of time a bridge donor has to wait, ensuring you get the most you’re going to get out of the chain, and then you donate the last kidney to the waiting list,” he says. “This way, you’ll ensure that every nondirected donor makes a direct contribution to the waiting list, you ensure that a center is incentivized to enroll their nondirected donors—because you can promise them that eventually that last kidney will come back to their list—and you minimize the risk of donors backing out long after their intended recipient has been transplanted.”

Reference

HHS Issues Updated Conflict of Interest Rule

In August, the U.S. Department of Health and Human Services (HHS) issued an updated Final Rule on conflict of interest that provides a framework for identifying, managing and ultimately avoiding researchers’ financial conflicts of interest.1

Major changes to the Final Rule include:

  • • Investigators are now required to disclose to their institutions all significant financial interests related to their institutional responsibilities;
  • • The monetary threshold at which significant financial interests require disclosure has been lowered, generally from $10,000 to $5,000;
  • • Institutions are required to report additional information on identified financial conflicts of interest and how they are being managed;
  • • Institutions must make certain information accessible to the public regarding significant financial interests held by key personnel; and
  • • Investigators must complete training related to the regulations and their institution's financial conflict of interest policy.

A spokesperson for the American Society of Transplantation (AST) says the organization's Conflict of Interest Committee reviewed the new policy and believed it did not need further discussion. The AST policy is available at http://www.a-s-t.org/about-ast by clicking on “Conflict of Interest” under Governing Documents. The American Society of Transplant Surgeons (ASTS), whose policy can be seen at http://www.asts.org/TheSociety under “Position Statements,” sent notice of the updates to all members in September. The current ASTS policy will be reviewed at an annual board meeting in January.

Reference

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