AAPS, American Association of Plastic Surgeons
AAPS, American Association of Plastic Surgeons
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2008 Annual Meeting Abstracts

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Composite Tissue Allotransplantation at 50 Years: Outcome Analysis and Ethical Lessons
Gordon R. Tobin, MD, Suzanne T. Ildstad, MD, Joseph F. Buell, MD, Martin M. Klapheke, MD, Warren C. Breidenbach, MD.
University of Louisville, Louisville, KY, USA.

The first successful human allograft was a 1957 flexor tendon composite tissue allograft (CTA) by visionary North Carolina surgeon, Erle E. Peacock, Jr. This landmark came between two other firsts, the 1954 renal isograft and 1959 renal allograft by Murray and Merrill. These three historic events launched the transplantation era.

PURPOSE:
Since Peacock’s 1957 case, over 12 CTA types were developed, and 127 recipients received 144 grafts. The purpose of this study is to: 1) provide the first comprehensive CTA outcome analysis, and 2) assess trends and ethical implications from outcomes.
METHODS:
Outcome data from 1957 through 2007 were extracted from scientific publications, the hand/CTA registry, CTA symposia, and investigator interviews. Analysis groups were by graft type and total experience. Success parameters included graft survival and objective functional restoration. Failure parameters included graft loss, functional failure, complications, and deaths. Failures were analyzed for cause, prevention, and ethical lessons.
RESULTS:
Cases (recipients/grafts) by CTA type are: flexor mechanism (digital sheath/tendons)-35+/41+, hand-31/41, laryngotracheal-22/22, face-3/3, tongue-1/1, scalp/ears-1/1, abdominal wall-14/15, knee/femur-9/9, peripheral nerve-8/8, uterus-1/1, penis-1/1, muscle-1/1, total-127/144. Outcome successes include: 1) flexor mechanism active range of motion (ROM) equals preoperative passive ROM in 70+%; 2) hand function is equivalent to same-level replants (Carroll test); 3) highly acceptable larynx speaking voice; 4) 70+% decannulation of laryngotracheal CTA’s; 5) highly acceptable facial reanimation; 6) regeneration across 75% of nerve grafts.
Six deaths resulted (4.7%). Three laryngotracheal recipients died and malignancies recurred fatally after 3 allografted cancer resections (larynx, tongue, scalp). Twenty-three grafts were lost from: unavailability of medication-7 (6 hands in China, larynx), non-compliance/psychiatric-3 (hand, penis, knee), infection-2 (knees), technical-4 (2 abdominal walls, uterus, hand), rejection-3 (2 knees, larynx), fracture-2 (knees), and indeterminate-2. Total functional failures included 1 flexor mechanism, 2 nerve non-regenerations and indeterminate hand numbers in China. Opportunistic infections and metabolic complications mirrored solid organ transplants, including 1 bilateral hip osteonecrosis requiring prosthetic replacement. No GVHD or malignancies were induced. No biopsies have yet shown chronic rejection vasculopathy, but a protracted acute rejection phenomenon emerged in immunosuppression withdrawals.
Indications were challenged in 6 cases (larynx, tongue, scalp, digit, uterus, penis). Striking outcome variation emerged between U.S./European and Chinese hand programs. All U.S./European recipients, except one, were closely monitored and adequately immunosuppressed, with graft survival and high-quality function. Chinese recipients were largely unmonitored and discontinued immunosuppression following healthcare system economic change, with all grafts amputated or functioning poorly.
CONCLUSION:
Skin-bearing allografts can now be sustained on renal immunosuppression protocols, with success rates equal or exceeding solid organs. Outcomes varied by CTA type. Nearly all poor outcomes were preventable by adopting safety systems, including: 1) scrutiny of indications; 2) psychiatric screening; 3) extreme caution with prior malignancy; 4) assuring lifelong immunosuppression; and 5) corticosteroid elimination and lessening immunosuppression. CTA investigators bear ethical obligations for these safety, monitoring and oversight systems. These findings support continuing clinical CTA studies and immunologic tolerance research.


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