Facial Allograft Donation: An Interpretative Phenomenological Analysis of the Experiences of Family Members.

Facial allograft transplantation can be regarded as a particular and complex type of donation because of its perceptibility and the importance of the face as an identity characteristic. As research on this topic is currently lacking, the objective of this study is to explore the experiences of the family members of the donor in facial allograft donation. In-depth, semi-structured interviews were conducted separately with the donor's family members and analyzed using interpretative phenomenological analysis. Six themes were identified: (1) Contrasting facial donation to that of more commonly donated organs; (2) Consenting to facial donation; (3) Expectations towards the recipient of the facial graft; (4) Expectations and consequences of restoration of the donor's face; (5) Relationship with the medical team during the process; and (6) Media attention. The findings of our study help to better support donor families through the facial donation process and to improve facial transplantation procedures.

Facing a New Face: An Interpretative Phenomenological Analysis of the Experiences of a Blind Face Transplant Patient and His Partner.

Increasing evidence points to good functional, aesthetic, and psychosocial outcomes after face transplantation. However, research investigating how patients and their families subjectively experience the transplantation process is lacking thus far. This study aims to investigate the personal experiences of a blind face transplant patient and his partner. In-depth interviews exploring different experiences were conducted with both partners separately 20 months after face transplantation. The interviews were analyzed using interpretative phenomenological analysis. Seven themes were identified in both interviews: coping with the facial trauma, motivation for the face transplantation, outcomes of the face transplantation, acceptance of the new face, gratitude toward the donor family, relation to the medical team, and dealing with the media. Two further themes were only mentioned by the patient (coping with complications and coping with blindness) and one theme only by the partner (loss of choices). The results of this study increase our understanding of the transplantation process as experienced by a face transplant recipient and his partner. They may help to better inform professionals to optimize transplantation procedures or supportive interventions.

Long-Term Multifunctional Outcome and Risks of Face Vascularized Composite Allotransplantation.

Vascularized composite allotransplantation (VCA) to reconstruct complex centrally located facial defects and to restore vital functions in a 1-staged procedure has worldwide gained acceptance. Continuous long-term multidisciplinary follow-up of face transplant patients is mandatory for surveillance of the complications associated with the immunosuppressive regime and for functional assessment of the graft. In December 2011, our multidisciplinary team performed a digitally planned face transplant at the Ghent University Hospital, Belgium on a 55-year-old man with a large central facial defect after a high-energy ballistic injury. The patient was closely followed to assess functional recovery, immunosuppressive complications, overall well-being, and quality of life. Three years postoperatively, the patient and his family are very satisfied with the overall outcome, and social reintegration in the community is successful. Motor and sensory functions have recovered near normal. Infectious and medical complications have been serious but successfully managed. Immunosuppressive maintenance therapy consists of corticoids, tacrolimus, and mycophenolate mofetil in minimal doses. Epithetic reconstruction of both eyes gave a tremendous improvement on the overall aesthetic outcome. Despite serious complications during the first 12 months, multifunctional outcome in the first face transplant in Belgium (#19 worldwide) is successful. This should be attributed to the continuous and long-term multidisciplinary team approach. As only few reports of other face transplant patients on long-term follow-up are available, more data need to be collected and reported to further outweigh the risk benefit ratio of this life changing surgery.

Facial transplantation in a blind patient: psychologic, marital, and family outcomes at 15 months follow-up.

BACKGROUND: Quality of life has frequently been reported to improve after vascularized composite allotransplantation of the face. However, psychosocial functioning of the partner or of particular patient groups such as blind patients are until now less well investigated. OBJECTIVE: The aim of this study is to investigate psychologic, marital, and family functioning of a blind 54-year-old patient, Mr. A, and his partner after facial transplantation. METHODS: Depressive and anxiety symptoms, hopelessness, personality, coping, resilience, illness cognitions, marital support, dyadic adjustment, family functioning, and quality of life of Mr. A and his partner were assessed before and after facial transplantation and at 15 months follow-up. Reliable change index (RCI) was further calculated to evaluate the magnitude of change. RESULTS: Most psychologic, marital, and family scores of both Mr. A and his partner were within a normative and healthy range before and after transplant and at 15 months follow-up. Resilience (RCI: 3.6), affective responsiveness (RCI: -3.6), and disease benefits (RCI: 2.6) of Mr. A further improved at 15 months follow-up whereas the physical quality of life (RCI: -14.8) strongly decreased. Only marital support (RCI: -2.1) and depth (RCI: -2.0) of the partner decreased at 15 months. CONCLUSIONS: The results of this study point to positive psychosocial outcomes in a blind patient after facial transplantation. Further, they may underscore the importance of good psychosocial functioning before transplantation of both partners and of their involvement in psychologic and psychiatric treatment. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.

Complex facial reconstruction by vascularized composite allotransplantation: the first Belgian case.

INTRODUCTION: Complex injuries to the central part of the face are difficult to reconstruct with the current plastic surgery methods. The ultimate one-staged approach to restore anatomy and vital facial functions is to perform a vascularized composite allotransplantation (VCA). METHODS: A 54-year-old man suffered from a high-energy ballistic injury, resulting in a large central facial defect. A temporary reconstruction was performed with a free plicated anterolateral thigh (ALT) flap. Considering the goal to optimally restore facial function and aesthetics, VCA was considered as an option for facial reconstruction. A multidisciplinary team approach, digital planning, and cadaver sessions preceded the transplantation. RESULTS: A digitally planned facial VCA was performed involving the bilateral maxillae, the hard palate, a part of the left mandible, and the soft tissues of the lower two-thirds of the face. Due to meticulous preparations, minimal adjustments were necessary to achieve good fitting in the recipient. At week 17, a grade 4 rejection was successfully treated; sensory and motor recovery was noted to occur from the fourth postoperative month. Several serious infectious and medical problems have occurred until 15-months postoperatively; following that, the clinical situation has remained stable. Two years postoperatively, the patient and his family are very satisfied with the overall outcome and social reintegration in the community is successful. CONCLUSION: The first face transplant in Belgium (#19 worldwide) was successful because of a meticulous 3-year preparation by a large multidisciplinary team. In our experience, preparatory cadaver dissections and three-dimensional (3D) computed tomographic (CT) modeling were valuable tools for an optimal intraoperative course and good alignment of the bony structures. Continuous long-term multidisciplinary follow-up is mandatory for surveillance of the complications associated with the immunosuppressive regime and for functional assessment of the graft.

Improved adherence to tacrolimus once-daily formulation in renal recipients: a randomized controlled trial using electronic monitoring.

BACKGROUND: With effective agents available to prevent posttransplantation acute organ rejection, medication adherence becomes a key factor for successful treatment outcomes after renal transplantation. A once-daily, modified-release oral formulation of tacrolimus has been developed to simplify dosing and improve medication adherence. METHODS: Adherence Measurement in Stable Renal Transplant Patients Following Conversion From Prograft to Advagraf is a randomized multicenter controlled trial to evaluate adherence between a tacrolimus once-daily regimen and a tacrolimus twice-daily regimen using an electronic monitor to document drug intake. After enrolment, all patients continued the twice-daily regimen for 3 months and then were randomized 2:1 between the two formulations and followed for 6 months. Adherence was decomposed into patients' persistence and implementation of each regimen. RESULTS: Two hundred nineteen patients (45% male; 3±2 years after transplantation) were analyzed (145 once daily and 74 twice daily). At 6 months after randomization, 81.5% of the once-daily group and 71.9% of the twice-daily group remained persistent with the treatment (P=0.0824). Among patients who remained engaged with the regimen, 88.2% of the once-daily group and 78.8% of the twice-daily group (P=0.0009) took the prescribed number of daily doses. When the patients took the twice-daily regimen, the average percentage of missed doses was 11.7% in the morning and 14.2% in the evening (P=0.0035). CONCLUSIONS: Regimen implementation of tacrolimus once daily is significantly superior to the twice-daily regimen. There was a residual prevalence of suboptimal adherence that will have to be countered by means other than reformulation and regimen simplification. Electronically compiled dosing histories provide detailed data on patient adherence that can be used for efficient medication management.

Immunogenicity and safety of an investigational AS02(v)-adjuvanted hepatitis B vaccine in patients with renal insufficiency who failed to respond or to maintain antibody levels after prior vaccination: results of two open, randomized, comparative trials.

An investigational AS02(v)-adjuvanted hepatitis B (HB-AS02) was compared with a licensed conventional recombinant hepatitis B vaccine (HBVAXPRO™; Sanofi Pasteur MSD, Lyon, France) in pre-dialysis, peritoneal dialysis and hemodialysis patients aged ≥18 years who had failed either to respond to prior vaccination with a conventional hepatitis B vaccine (Study A; n=251) or to maintain protective antibody concentrations after prior hepatitis B vaccination (Study B; n=181). These were open, randomized, comparative trials. Mean (range) age was 65.9 (31-92) and 64.6 (29-92) years in the two studies, respectively. In Study A, two doses of HB-AS02 given one month apart were found to be superior to two doses of the licensed vaccine in terms of seroprotection rate (76.9% versus 37.6%) and anti-HBs geometric mean antibody concentration (GMC; 139.3 versus 6.9mIU/ml), with antibody concentrations ≥100mIU/ml in 61.1% and 15.4% of subjects in the two groups, respectively. In Study B, one month after administration of a single booster dose, seroprotection rates were 89.0% in the HB-AS02 group and 90.8% in the licensed vaccine group, 81.3% and 60.9% of subjects had antibody concentrations ≥100mIU/ml, and anti-HBs GMCs were 1726.8 and 189.5mIU/ml. HB-AS02 was found to be more reactogenic than the licensed vaccine. In summary, the investigational HB-AS02 vaccine induced higher seroprotection rates and anti-HBs GMCs than a licensed conventional hepatitis B vaccine in uremic patients who had failed to respond or to maintain protective antibody titers after prior hepatitis B vaccination.

Pharmacokinetics of atorvastatin and its metabolites after single and multiple dosing in hypercholesterolaemic haemodialysis patients.

BACKGROUND: Patients with chronic renal failure commonly suffer from a secondary form of complex dyslipidaemia, and may benefit from lipid-lowering treatment. Atorvastatin has been shown to reduce efficiently the levels of atherogenic lipoproteins also in patients with renal failure, but pharmacokinetic data in haemodialysis patients are lacking. METHODS: In this study, hypercholesterolaemic haemodialysis patients received 40 mg (n=12) or 80 mg (n=11) atorvastatin once daily, first as a single dose and then continuously for 2 weeks. Plasma levels of atorvastatin and its active and inactive metabolites were measured by LC/MS/MS, and pharmacokinetic parameters (C(max), t(max), AUC, t(1/2)) compared between single and multiple dosing, and between the different doses. RESULTS: The pharmacokinetic parameters of the parent drug atorvastatin acid were not significantly different after single and 2-week multiple dosing; they showed dose-proportionality between the 40 and 80 mg dose, and were comparable to findings in healthy volunteers. Dose-proportionality and absence of accumulation was also observed for the major active metabolite ortho-hydroxy-atorvastatin and the inactive metabolites atorvastatin lactone and ortho-hydroxy-atorvastatin lactone, but the levels of the active metabolite were relatively lower, and the inactive metabolites higher, compared with healthy volunteers. The para-hydroxy-metabolites constituted only a minor pathway in atorvastatin's metabolic elimination. Haemodialysis did not cause enhanced clearance of atorvastatin or its metabolites, the drug was well tolerated and there were no serious adverse events. CONCLUSION: While subtle differences may exist in the metabolic processing of atorvastatin in haemodialysis patients, active drug did not accumulate nor did it show enhanced elimination, and levels were comparable to those measured in healthy volunteers. Therefore there is no need to adapt atorvastatin dosage in this particular patient population.