Immunosuppression Risks of Face Transplants Overstated

LOUISVILLE, Ky., Aug. 29 -- Facial transplantation involves less immunosuppression-related risk than previously estimated, investigators here reported.

Prior estimates derived from heterogeneous datasets presented an inaccurate and misleading picture of the immunosuppressive risks, John H. Barker, M.D., Ph.D., of the University of Louisville, and colleagues, reported in the September issue of Plastic and Reconstructive Surgery.

The investigators' review of comparable data on immunosuppression regimen, recipient health status, and condition of the transplanted tissue revealed a substantially lower risk of acute rejection, acute rejection reversibility, chronic rejection, cytomegalovirus disease, diabetes, hypertension, and renal failure.

"These updated risk estimates should be used by facial transplant teams, institutional review boards, and potential recipients when considering the immunologic risks associated with facial transplantation," the authors concluded.

French clinicians pioneered in a face transplant, though a handful of U.S, groups have revealed such plans.

The emergence of facial transplantation as a treatment option for severe facial injuries and deformities has sparked considerable debate about the ethics of such treatment, Dr. Baker and colleagues noted. The controversy centers on the issue of whether the risks of lifelong immunosuppressive therapy justify the benefits.

Critics of facial transplantation have often relied on data in a 2004 report from England's Royal College of Surgeons. That report cited immunosuppression-related risks that included a 10% rate of graft loss from acute rejection in the first year and chronic rejection leading to graft loss of 30-50% over the first two to five years

"These projections have had a great influence on framing the risk-versus-benefit debate in face transplantation," the authors wrote, "and indeed have even influenced the position statements published by influential bodies representing plastic surgeons."

Dr. Baker and colleagues asserted that the data are inaccurate and misleading for three principal reasons:

• Risk estimates were based on immunosuppression regimens that are not being used in facial transplantation.
• The health status of solid organ recipients differs substantially from that of face transplant recipients.
• The tissue composition and antigenicity of solid organs differs substantially from that of facial tissues.

To back up their assertion, the authors reviewed data on 10-year clinical experience with kidney transplantation and five-year experience with hand transplantation. All studies included in the review employed tacrolimus/mycophenolate mofetil/corticosteroid immunosuppression.

The investigators also took into account mitigating factors such as ease of rejection diagnosis, rejection reversibility, infection prophylaxis, patient selection, and viral serologic status.

The review produced the following estimated risks:

• Acute rejection: 10-70%
• Acute rejection reversibility: ~100% with steroids alone
• Chronic rejection: Less than 10% at five years
• Cytomegalovirus disease: 1-15%
• Diabetes: 5-15%
• Hypertension: 5-10%
• Renal failure: Less than 5%

"When estimating the risks of graft loss, acute and chronic rejection, and drug toxicity in face transplant recipients, it is important to compare 'apples with apples,'" the authors commented.

"We provide relevant risk data from large solid organ studies and human hand transplantation," they continued. "On the basis of these data, we provide more accurate estimations/extrapolations of rejection and complication rates for facial transplants."