Richmond, Va. – The OPTN/UNOS Board of Directors, at its meeting June 23 and 24, unanimously approved the first national policies and standards for transplantation of limbs, faces and other structures collectively known as vascularized composite allografts (VCAs). The requirements will be in effect for 15 months, allowing the transplant network during that time to seek public comment regarding potential improvements.
“These policies establish the framework for further development of this groundbreaking therapy, which returns vital function and identity to people who have suffered a devastating injury or illness,” said OPTN/UNOS President Kenneth Andreoni, M.D. “We want to make this treatment more widely available while recognizing the unique medical and ethical issues involved.”
VCAs involve the transplantation of multiple structures that may include skin, bone, muscles, blood vessels, nerves and connective tissue. Through January 2014, 28 VCA transplants have been performed at 11 hospitals in the United States. These procedures have included transplantation of the face and either single or double hands.
The items approved by the Board, to be effective beginning July 3, include:
- criteria for defining VCAs to be covered in OPTN policy
- OPTN membership requirements for VCA transplant programs
- initial policies for VCA allocation
- guidance for gaining specific consent for donation of VCAs
In addition to seeking public comment on the initial requirements, the OPTN/UNOS Vascularized Composite Allograft Transplantation Committee will continue development of other aspects of VCA policy. Priorities include refining allocation policy, data requirements and data collection procedures for VCAs.
In separate action, the Board approved amendments to heart allocation policy for pediatric candidates (those listed for a transplant before their 18th birthday), with the goals of reducing wait list deaths and providing better access to available organ offers.
The revised pediatric heart policy includes a redefinition of medical criteria for the two highest urgency statuses (Status 1A and 1B) to lessen the effect of waiting time among candidates in these status groups. Infants with high medical urgency will also have greater access to hearts from donors of incompatible blood types. These hearts can be transplanted safely for some infant candidates because their immune system has not developed enough to reject such organs. In addition, to better reflect current clinical practice, the policy eliminates a rarely used provision that allowed candidates to be listed for a transplant shortly before birth.
In other developments, the Board adopted a recommendation to the Health Resources and Services Administration that the OPTN/UNOS Kidney Paired Donation Pilot Program should become a permanent function of the OPTN, thus ending the pilot phase of its development. Since the program became operational in December 2010, it has coordinated 97 kidney transplants at 45 hospitals across the country.
The Board also approved minimum requirements for living liver donor transplant programs to report post-operative outcome data on those donors at intervals up to two years from the donation. Similar to standards enacted previously for reporting of data on living kidney donors, living liver donor transplant programs must report accurate, complete and timely donor status information for at least 80 percent of donors who donate on or after September 1, 2014. They must also report accurate, complete and timely laboratory data on living donors for at least 70 percent of donors one year from donation.
Additionally, the Board approved on a permanent basis a policy change allowing transplant programs to request additional, exceptional priority for adolescent or adult donor lung offers for transplant candidates age 11 or younger. The action followed additional review of a temporary exception adopted in 2013.
United Network for Organ Sharing (UNOS) serves as the Organ Procurement and Transplantation Network (OPTN) by contract with the U.S. Department of Health and Human Services, Health Resources and Services Administration, Division of Transplantation. The OPTN brings together medical professionals, transplant recipients and donor families to develop organ transplantation policy.