*Purpose: Face transplantation (FT) holds promise of restoring form and function to patients with severe facial disfigurement not amenable to traditional reconstructive procedures. However, quantitative outcome reports beyond two years post-FT are scarce. This prospective open study aims to fully understand the long-term impact of FT by reporting comprehensive outcome measures.

*Methods: Four patients with full and two patients with partial FT were included in this study. Prospective outcome measures regarding sensory (two-point discrimination, calorimetric and monofilament testing) and motor (Daniels & Worthingham Manual Muscle Testing) recovery, and quality of life (EQ-5D self-rated health status) were acquired at designated time intervals (three-monthly in the first post-operative year and six-monthly thereafter). Analysis of complications included rejection episodes, opportunistic infections, oncologic and metabolic complications.

*Results: Median follow-up time was 5 years (range 3.5-5) and median age at transplantation was 35.5 years (range 25-57). Maintenance immunosuppression consisted typically of triple therapy with tacrolimus (target levels 6-10 ng/mL after first year), mycophenolate and prednisone, while steroids were completely weaned in four patients. There was statistically significant (p<0.001) improvement in sensory and motor function throughout the first post-operative year. For motor function, there was further significant (p=0.002) improvement after first year, reaching an average of 60% of maximal motor function. The median EQ-5D score improved from baseline 75 (range 60-95) to 82.5 (range 50-93) at maximal follow-up. Patients experienced a median of 5.5 acute rejection episodes (range 2-7) requiring treatment. Infectious episodes were most commonly of bacterial etiology. All rejection and infectious episodes resolved with appropriate treatment. No malignancies were documented to date. There were no cases of new-onset diabetes mellitus, hypertension or lipid disorders post-transplant. A mean decrease of 22 ml/min glomerular filtration rate (GFR) occurred within the first year post-transplant but the GFR never dropped below 60 ml/min at five years of follow-up. Chronic face allograft changes such as skin sclerosis and adnexal atrophy were documented in two patients but with no clear evidence of allograft vasculopathy on histology. No allograft losses or patient fatalities occurred.

*Conclusions: Long-term outcomes of FT are promising. Continued monitoring of detailed outcome measures is paramount to fully understand the risks and benefits of this novel intervention. We propose the evaluation of standardized and reproducible outcome measures, which are thorough yet easy to follow, across all FT centers.

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