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Current Concepts in Vascularized Composite Allotransplantation: Lessons Learned from the Development of a Reconstructive Transplantation Program to the Institution’s First Transplant
Curtis L. Cetrulo, Jr., M.D., FACS, Jonathon Winograd, M.D., FACS, Camille Kotton, M.D, James W. May, Jr., M.D., FACS, Michael J. Yaremchuk, M.D., FACS, Amy S. Colwell, M.D., Eric C. Liao, M.D., Ph.D, FACS, William G. Austen, Jr., M.D., FACS.
Massachusetts General Hospital, Boston, MA, USA.

Purpose:
Reconstructive transplantation procedures offer restoration of function and form to patients suffering the most severely disfiguring injuries. We illustrate unique features of our vascularized composite allotransplantation (VCA) program from its inception to our recently-performed first transplant.
Methods:
Clinical vs. Research Protocol (SOC vs. IRB)
Fiscal support from our institution was ensured with a strategic planning initiative and a standard-of-care clinical protocol based on triple drug immunosuppression was developed. However, as numerous opportunities for research questions arose in our cohort of potential patients- including the potential for tolerance induction protocols- we opted instead to acquire Institutional Review Board approval of a research protocol.
UNOS/OPTN Regulatory Compliance
Our plastic surgery, hand surgery and transplant surgery divisions coordinated to establish VCA as an organ transplant procedure subject to clinical practice policies approved by UNOS/OPTN in anticipation of the pending regulatory oversight that will govern VCAs as organs.
Allocation Algorithm
We designed with our OPO a VCA-specific (i.e. hand vs. face vs. abdominal wall) allocation algorithm based on ethical principles common to solid organ transplantation (SOT), but also unique to hand transplantation.
Infectious Disease Prophylaxis
We gathered data from national and international VCA programs to obtain consensus on best practice for infectious disease prophylaxis in VCA.
Results:
Unilateral Dominant Distal Amputee Status Post Burn Sequelae
We performed a distal hand transplant with a large proximal volar forearm flap from the donor in a patient with a distal unilateral dominant amputation and absent cutaneous forearm veins secondary to the burn injury. The design of our donor flap or transplant optimized venous outflow as well as a strategy to achieve intrinsic functional recovery in the hand. In addition, we opted for a cytomegalovirus negative donor-recipient pair.
Donor Recovery and Management of Cold Ischemia Time
Donor recovery proceeded as planned within the 2 hour calculated time frame. We achieved a favorable osteosynthesis, a functional cascade, and perfusion of the allograft in 5.5 hours of cold ischemia time. An infraclavicular catheter was inserted for sympathectomy, which provided excellent peripheral vasodilation.
Hand Therapy
Protocols were initiated preoperatively to assess patient compliance, condition forearm musculature and maximize extrinsic tendon excursion with ???. An aggressive t.i.d. protected active motion protocol was initiated on posttransplant day one.
Immunosuppression
Triple therapy immunosuppression with rapid steroid weaning followed ATG, MMF and steroid induction. Goals of early posttransplant maintenance included 12-14ng levels of tacrolimus to 1) enhance peripheral nerve regeneration and 2) prevent early acute rejection episodes that have been associated with vasculopathy in experimental models and clinical reports.
Conclusion:
Over 100 patients have benefited from VCA procedures. Our case illustrates challenges and opportunities on many fronts including regulatory, financial, immunologic and surgical issues that require comprehensive strategic planning to optimize outcomes.




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