title: Face transplant: long-term follow-up and results of a prospective open study.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  Protocole Hospitalier de Recherche Clinique (PHRC) National.
authors: Service de Chirurgie Plastique, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris (APHP), Université Paris Descartes, Paris, France.
authors: Laurent
authors: L
authors: Lantieri
authors: Service de Néphrologie et Transplantation, Hôpital Henri Mondor, APHP, Creteil, France-Université Paris Est Creteil (UPEC), Paris France.
authors: Philippe
authors: P
authors: Grimbert
authors: Département de Pathologie, Hôpital Henri Mondor, APHP, Creteil, France-Université Paris Est Creteil (UPEC), Paris France.
authors: Nicolas
authors: N
authors: Ortonne
authors: Laboratoire Régional d'Histocompatibilité «Jean Dausset», Hôpital Saint Louis, APHP, Paris, France; Université Paris Diderot, Paris, France.
authors: Caroline
authors: C
authors: Suberbielle
authors: Laboratoire D'Hématologie Biologique et Moléculaire, Hôpital Henri Mondor, APHP, Creteil, France-Université Paris Est Creteil (UPEC), Paris France.
authors: Dominique
authors: D
authors: Bories
authors: Unitat Assistencial de Trasplantament, Bellvitge Hospital Universitari, Barcelona, Spain.
authors: Salvador
authors: S
authors: Gil-Vernet
authors: Service de Psychiatrie, Hôpital Européen Georges Pompidou, APHP-Université Paris Descartes, Paris, France.
authors: Cédric
authors: C
authors: Lemogne
authors: Université Paris Diderot, Sorbonne Paris Cité, INSERM UMR-S 1144, Paris, France; APHP, GH Saint-Louis-Lariboisière-F Widal, Département de Psychiatrie et de Médecine Addictologique.
authors: Frank
authors: F
authors: Bellivier
authors: Service des Explorations Fonctionnelles, Hôpital Henri Mondor, APHP, Creteil, France-Université Paris Est Creteil (UPEC), Paris France.
authors: Jean Pascal
authors: JP
authors: Lefaucheur
authors: Service de Chirurgie Plastique, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris (APHP), Université Paris Descartes, Paris, France.
authors: Nathaniel
authors: N
authors: Schaffer
authors: Paris, France.
authors: Fréderic
authors: F
authors: Martin
authors: Service de Chirurgie Plastique et Reconstructrice, Hôpital Henri Mondor, APHP, Creteil, France-Université Paris Est Creteil (UPEC), Paris France.
authors: Jean Paul
authors: JP
authors: Meningaud
authors: Service de Dermatologie, Hôpital Henri Mondor, APHP, Creteil, France-Université Paris Est Creteil (UPEC), Paris France.
authors: Pierre
authors: P
authors: Wolkenstein
authors: Service de Chirurgie Plastique, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris (APHP), Université Paris Descartes, Paris, France. Electronic address: mikael.hivelin@aphp.fr.
authors: Mikael
authors: M
authors: Hivelin