Development of a Clinical Vascularized Composite Allotransplantation Program: Requirements and Recommendations

Vascularized composite allotransplantation (VCA) can achieve close to optimal aesthetic restoration of devastating tissue defects not amenable to conventional reconstruction, with improved functional outcomes and avoidance of multiple surgeries or donor site morbidity. During the past decade, more than 50 VCA programs have been established around the world, performing more than 150 VCA procedures including over 100 upper extremity and 30 facial transplants. Clinical VCA requires a multidisciplinary team of providers with extensive experience in issues faced by patients with complex trauma. The VCA team should thus include hand, plastic, orthopedic, head and neck, and transplant surgeons; internists; physical therapists; psychiatrists; pharmacists, and anesthesiologists. In addition, the transplant coordinator, social workers, caregivers, and patient advocates play an important role. This is a comprehensive overview of the key prerequisites for the planning and establishment of a successful clinical VCA program. It highlights the preapproval; personnel; procedures; preoperative, perioperative, and postoperative protocols and procedures; required infrastructure; resources; psychosocial, pharmacologic, and physical therapies involved in patient selection, and management and procurement aspects that are critical components of a VCA program. Key aspects of VCA programs that are discussed include media and public relations, regulatory and fiscal considerations, and ethical concerns.