Citation

Lantieri L, Grimbert P, Ortonne N, Suberbielle C, Bories D, Gil-Vernet S, Lemogne C, Bellivier F, Lefaucheur JP, Schaffer N, Martin F, Meningaud JP, Wolkenstein P, Hivelin M. Lancet 2016; 388(10052): 1398-1407.

Copyright

(Copyright © 2016, Elsevier Publishing)

DOI

10.1016/S0140-6736(16)31138-2

PMID

unavailable

Abstract

Background More than 30 face transplantations have been done worldwide since 2005 but no documented long-term follow-up has been reported in the literature. We aimed to answer remaining question about the long-term risks and benefits of face transplant.

METHODS In this single-centre, prospective, open study, we assessed 20 patients presenting with facial defects. Ten patients were selected, and, after three were secondarily excluded, seven were transplanted: two with neurofibromatosis 1, one with a burn, and four with self-inflicted facial gunshot injuries. We report the long-term outcomes of six face allotransplant recipients at an average of 6 years (range 3·4-9 years) after the transplantation. All admissions to hospital except for planned revisions and immunosuppressive follow-up therapy were reported as adverse events (safety endpoint). Predefined immunological, metabolic, surgical, and social integration endpoints were collected prospectively. Patients underwent quantitative health-related quality of life assessments through Short Form 36 health questionnaires. This study was registered with ClinicalTrials.gov, number NCT00527280.

FINDINGS Two of seven patients died: one at 65 days due to transplant destruction with concomitant pseudomonas infection and the second at 3·4 years after transplantation by suicide. The six patients alive at long-term follow-up presented with functional transplants. Safety endpoints were related to infection in the first month, acute rejection from 1 day to 7 years after transplantation, or side-effects of immunosuppressive therapy. Recurrent rejection episodes justified maintenance therapy with high-dose steroids at high levels in all patients at last follow-up, yet none of the patients developed diabetes. Three patients were found to have hypertension with one requiring therapy. All patients had a noticeable reduction in glomerular filtration rate. All recipients and their families accepted their transplant. Improvements in social integration and quality of life were highly variable among the patients and depended on baseline levels and psychiatric comorbidities. Interpretation These long-term results show the crucial effect of patients' social support and pre-existing psychiatric conditions on the risk-benefit ratio of facial transplantation. Careful preoperative patient selection and long-term postoperative follow-up programmes under strict institutional review board controls should be used for any future grafts of this type. Funding Protocole Hospitalier de Recherche Clinique (PHRC) National. © 2016 Elsevier Ltd

Language: en

Keywords

adult; human; burn; male; alcoholism; quality of life; depression; suicide attempt; comorbidity; mental disease; gunshot injury; antihypertensive agent; clinical article; hospital admission; human tissue; virus infection; priority journal; steroid; graft versus host reaction; drug safety; family history; drug dependence; follow up; hypercholesterolemia; cardiovascular disease; steroid therapy; hypertension; bipolar II disorder; prospective study; maintenance therapy; diabetes mellitus; methylprednisolone; immunosuppressive treatment; tacrolimus; immunosuppressive agent; hair loss; drug dose reduction; acute graft rejection; cytomegalovirus infection; thymocyte antibody; Article; hypertriglyceridemia; bacterial infection; outcome assessment; open study; integration; Short Form 36; face malformation; glomerulus filtration rate; antiviral therapy; ganciclovir; foscarnet; mycophenolate mofetil; skin biopsy; antihypertensive therapy; Pseudomonas infection; facial transplantation; neurofibromatosis type 1; photopheresis; sialoadenitis; synkinesis; xeroderma pigmentosum