Incorporating Trauma-informed Approaches to Care in Vascularized Composite Allotransplantation.

Since 1998, vascularized composite allotransplantation (VCA) has been a growing area of research in the field of reconstructive surgery. Although conditions treated with VCA often result from a traumatic injury, there has been limited emphasis on incorporating trauma-informed care (TIC) models in VCA. Considering the importance of psychosocial well-being in VCA candidates and recipients, applying best practices in TIC to the face, upper extremity, and penile transplantation may be critical in minimizing retraumatization throughout the perioperative process. There are six main principles of TIC: safety; trustworthiness and transparency; peer support; collaboration and mutuality; empowerment and choice; and cultural, historical, and gender issues, which may be further incorporated in care for VCA patients. Evaluating for PTSD and incorporating TIC may have substantial benefit to postoperative outcomes.

First-in-Human Whole-Eye Transplantation: Ensuring an Ethical Approach to Surgical Innovation.

As innovations in the field of vascular composite allotransplantation (VCA) progress, whole-eye transplantation (WET) is poised to transition from non-human mammalian models to living human recipients. Present treatment options for vision loss are generally considered suboptimal, and attendant concerns ranging from aesthetics and prosthesis maintenance to social stigma may be mitigated by WET. Potential benefits to WET recipients may also include partial vision restoration, psychosocial benefits related to identity and social integration, improvements in physical comfort and function, and reduced surgical risk associated with a biologic eye compared to a prosthesis. Perioperative and postoperative risks of WET are expected to be comparable to those of facial transplantation (FT), and may be similarly mitigated by immunosuppressive protocols, adequate psychosocial support, and a thorough selection process for both the recipient and donor. To minimize the risks associated with immunosuppressive medications, the first attempts in human recipients will likely be performed in conjunction with a FT. If first-in-human attempts at combined FT-WET prove successful and the biologic eye survives, this opens the door for further advancement in the field of vision restoration by means of a viable surgical option. This analysis integrates recent innovations in WET research with the existing discourse on the ethics of surgical innovation and offers preliminary guidance to VCA programs considering undertaking WET in human recipients.

Technical Feasibility of Whole-eye Vascular Composite Allotransplantation: A Systematic Review.

There are over 43 million individuals in the world who are blind. As retinal ganglion cells are incapable of regeneration, treatment modalities for this condition are limited. Since first incepted in 1885, whole-eye transplantation (WET) has been proposed as the ultimate cure for blindness. As the field evolves, different aspects of the surgery have been individually explored, including allograft viability, retinal survival, and optic nerve regeneration. Due to the paucity in the WET literature, we aimed to systematically review proposed WET surgical techniques to assess surgical feasibility. Additionally, we hope to identify barriers to future clinical application and potential ethical concerns that could be raised with surgery. Methods: We conducted a systematic review of PubMed, Embase, Cochrane Library, and Scopus from inception to June 10, 2022, to identify articles pertaining to WET. Data collection included model organisms studied, surgical techniques utilized, and postoperative functional outcomes. Results: Our results yielded 33 articles, including 14 mammalian and 19 cold-blooded models. In studies performing microvascular anastomosis in mammals, 96% of allografts survived after surgery. With nervous coaptation, 82.9% of retinas had positive electroretinogram signals after surgery, indicating functional retinal cells after transplantation. Results on optic nerve function were inconclusive. Ocular-motor functionality was rarely addressed. Conclusions: Regarding allograft survival, WET appears feasible with no complications to the recipient recorded in previous literature. Functional restoration is potentially achievable with a demonstrated positive retinal survival in live models. Nevertheless, the potential of optic nerve regeneration remains undetermined.

Older Adults' Lived Experience of Kidney Transplantation.

BACKGROUND AND OBJECTIVES: The United States is witnessing a rapid increase in kidney transplantation (KTx) among adults aged 65 and older. Despite this demographic shift, older adults' perspectives on KTx remain notably absent from the discourse on transplant policy and practice, and very little research has examined older adults' perceptions and experiences of KTx. RESEARCH DESIGN AND METHODS: Employing a phenomenological approach, this study explored the lived experiences of 10 KTx recipients aged 65 and older. Fifteen in-depth interviews were conducted, and analyses followed the processes of phenomenological reduction, imaginative variation, and synthesis. RESULTS: Participants reported experiencing an initial disruption of their sense of embodied identity that ranged from mildly unsettling to deeply distressing. However, they described navigating this "liminal" period and eventually incorporating the donor kidney into their sense of embodied self. Notably, most participants viewed their older age as protective and reported that their lived experience over time enabled them to cope more effectively with the challenges they faced during the posttransplant recovery and adaptation period. DISCUSSION AND IMPLICATIONS: Findings from this study can inform more equitable and age-responsive KTx policy, research and clinical practice and may be extended beyond KTx to other forms of solid organ transplantation, vascularized composite allotransplantation, and innovative bioengineered organs.

Social support criteria in vascularized composite allotransplantation versus solid organ transplantation: Should the same ethical considerations apply?

The field of vascularized composite allotransplantation (VCA) is evolving, with some procedures poised to transition from highly experimental research toward standard of care. At present, the use of social support as an eligibility criterion for VCA candidacy is at the discretion of individual VCA programs, allowing VCA teams to consider the unique needs of each potential candidate. Yet this flexibility also creates potential for bias during the evaluation process which may disproportionately impact members of certain communities where social configurations may not resemble the model considered "optimal." We examine the extent to which ethical considerations for social support in solid organ transplantation (SOT) may be applied to or adapted for VCA, and the ethically meaningful ways in which VCA procedures differ from SOT. We conclude that VCA programs must retain some flexibility in determining criteria for candidacy at present; however, considerations of equity will become more pressing as VCA procedures evolve toward standard of care, and further empirical evidence will be needed to demonstrate the association between social support and post-operative success. The field of VCA has an opportunity to proactively address considerations of equity and justice and incorporate fair, inclusive practices into this innovative area of transplantation.

Recognizing Racial Disparities in Postoperative Outcomes of Gender Affirming Surgery.

Purpose: Given the increasing frequency with which gender affirming surgery (GAS) is performed, understanding risk factors for poor outcomes is imperative. Recent investigations highlight inferior health outcomes experienced by Black transgender and gender expansive (TGE) individuals. Herein, we evaluate the relationship between race and postoperative outcomes in TGE patients undergoing GAS, utilizing the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP). Methods: We conducted a retrospective review of ACS NSQIP from 2010 to 2018. Patients with a primary diagnosis of gender dysphoria undergoing GAS were identified and grouped by race. Patient characteristics and 30-day postoperative outcomes were recorded. Univariate analysis was used to compare patient characteristics and postoperative outcomes across groups. Multivariate logistic regression was used to determine independent predictors of complications. Results: We included 2308 patients (1780 White, 419 Black, 109 Asian). Gender, body mass index, smoking status, and type of surgery performed differed significantly between groups (p < 0.001). Univariate analysis revealed significant differences in 30-day readmission and organ space surgical site infection (SSI) across groups (p = 0.03). Multivariate logistic regression, adjusted for confounders, revealed that Black patients had higher odds of reoperation (odds ratio [OR] 1.82, p = 0.047), 30-day readmission (OR 2.46, p = 0.003), and organ space SSI (OR 4.65, p = 0.024) than White patients. Conclusion: We found that race was an independent predictor of important short-term postoperative outcomes in GAS. Inclusive clinical research, effective engagement with the TGE community, and surgery-specific enhanced recovery after surgery protocols may help address disparities, but we must acknowledge race as a social determinant of health.

Trends, Gaps, and Collaboration in Facial Transplantation: A Bibliometric Study.

Facial transplantation (FT) has advanced extensively over the past two decades, with over 40 transplants performed to date. Over this time, the FT literature has evolved as well, from early discussions on ethics and feasibility of FT to functional outcomes reports more recently. We aimed to evaluate the entire body of FT literature to identify trends in publications over time in addition to current existing gaps in the field. Methods: We conducted a comprehensive bibliometric analysis of the published FT literature from 1994, the first year FT was mentioned in the literature, through July 2020. Co-authorship and keyword information were analyzed using VOSviewer. Articles were manually categorized based on keywords and their aim to provide insight on trends. Results: A total of 2182 articles were identified. Analysis identified the top 50 publishing authors in the field and demonstrated co-authorship linkage between 84.8% of the top 1000 authors. Clinical surgical techniques, protocols, and experiments were the most frequently published category. Within clinical outcomes, immunologic outcomes were most frequent, while psychosocial were the lowest. Gaps were identified in long-term outcomes reporting and patient-reported outcomes, with physician-reported outcomes heavily outweighing patient-reported outcomes. Conclusions: As the field continues to evolve, rigorous tracking of publication patterns over time will encourage development of a more robust evidence base, identify gaps in the published literature, and highlight opportunities to enhance collaboration in the field. This data will provide surgeons and research institutions with information to further improve this life-changing procedure.

A Comparison of Immunosuppression Regimens in Hand, Face, and Kidney Transplantation.

BACKGROUND: Authors have speculated that vascularized composite allotransplantation (VCA) recipients may require greater maintenance immunosuppression than solid organ transplant (SOT) recipients due to the higher antigenicity of skin. However, detailed comparisons of VCA and SOT immunosuppression regimens have been limited. METHODS: Hand and face VCA recipient immunosuppression data were collected through a systematic literature review. Kidney recipient data were obtained through a retrospective chart review of the authors' institution. Prednisone and mycophenolate mofetil (MMF) doses were compared between VCA and kidney recipients at predefined follow-up intervals (<1, 1-5, and >5 y). Tacrolimus target trough levels (TTTL) were compared at follow-up intervals of 1-5 and >5 y, and stratified into our institution's kidney transplant risk-based target ranges (4-6 ng/mL, 6-8 ng/mL) or higher (>8 ng/mL). RESULTS: Immunosuppression data were available for 57 VCA and 98 kidney recipients. There were no significant differences in prednisone doses between groups at all follow-up intervals. VCA recipient mean MMF dose was significantly greater at <1-y (1.71 ± 0.58 versus 1.16 ± 0.55 gm/d; P = 0.01). For VCA recipients, there was a significant difference (P = 0.02) in TTTL distribution over the three predefined therapeutic ranges (4-6 ng/mL, 6-8 ng/mL, and >8 ng/mL) between 1 and 5 y (24.0%, 20.0%, 56.0%, respectively) and >5 y (28.6%, 42.9%, 28.6%). CONCLUSIONS: At longer follow-up, VCA and kidney recipients receive comparable MMF/prednisone doses, and most VCA recipients are treated with TTTL similar to kidney recipients. Further research may improve our understanding of VCA's complex risk/benefit ratio, and enhance informed consent.

Equity in access to facial transplantation.

We examine ethical considerations in access to facial transplantation (FT), with implications for promoting health equity. As a form of vascularised composite allotransplantation, FT is still considered innovative with a relatively low volume of procedures performed to date by a small number of active FT programmes worldwide. However, as numbers continue to increase and institutions look to establish new FT programmes, we anticipate that attention will shift from feasibility towards ensuring the benefits of FT are equitably available to those in need. This manuscript assesses barriers to care and their ethical implications across a number of considerations, with the intent of mapping various factors relating to health equity and fair access to FT. Evidence is drawn from an evolving clinical experience as well as published scholarship addressing several dimensions of access to FT. We also explore novel concerns that have yet to be mentioned in the literature.

Perceptions of Quality of Life among Face Transplant Recipients: A Qualitative Content Analysis.

The aim of facial transplantation (FT) was to enhance quality of life (QoL) for individuals living with severe facial disfigurement. Yet QoL has proved challenging to assess, as the field lacks a unified approach for incorporating FT recipients' perspectives into meaningful QoL measures. In this study, we review FT recipients' self-reported QoL through a qualitative analysis of publicly available posttransplant interviews to identify the aspects of QoL they report as meaningful. METHODS: A conventional qualitative content analysis was conducted through a comprehensive review of publicly available interviews with FT recipients. Data sources included English language audio, video, and online print interviews from 2008 to 2019. Recipient interview data were obtained for both partial and full FT recipients located in North America through Google and YouTube searches. Audio and video interviews were transcribed, and an inductive content analysis was used to develop and apply a coding scheme to all interview transcripts. Codes were subsequently grouped into categories and interpreted into themes. RESULTS: In total, 81 interviews representing 12 North American, English-speaking face transplant recipients were collected from internet sources, of which 74 interviews remained after exclusion criteria were applied. Three themes emerged representing the dimensions of QoL emphasized by FT recipients: (1) reconstitution and re-embodiment of physical/corporeal selfhood, (2) integrity of cognitive/emotional selfhood, and (3) social selfhood and the importance of social integration. CONCLUSIONS: This study provides an insight into North American FT recipients' experiences, values, and goals and illuminates critical aspects of QoL that are meaningful to this unique patient population, which may not be fully captured by currently available assessment tools. The themes developed in this study link facets of QoL to the overall significance of embodied selfhood among FT recipients and will help inform the future development of FT-specific patient-reported QoL outcome measures.

Equitable access to ectogenesis for sexual and gender minorities.

As the technology for ectogenesis continues to advance, the ethical implications of such developments should be thoroughly and proactively explored. The possibility of full ectogenesis remains hypothetical at present, and myriad concerns regarding the safety and efficacy of the technology must be evaluated and addressed, while pressing moral considerations should be fully deliberated. However, it is conceivable that the technology may become sufficiently well established in the future and that eventually full ectogenesis might be deemed ethically acceptable as a reproductive alternative to gestation within a human womb under certain circumstances. If the safety and efficacy of full ectogenesis are established, if ethical dilemmas are sufficiently well addressed, and if the technology is offered as a reproductive option to cisgender heterosexual individuals or couples desiring to become parents, there is a moral obligation grounded in social justice to ensure that full ectogenesis be made available to individuals or couples identifying as members of sexual- or gender-minority groups who likewise seek to pursue parenthood. We examine the history of access to current family-building options, including assisted reproductive technology, surrogacy and adoption, for these populations and conclude that in the absence of robust empirical evidence suggesting an increased risk of harm to children of individuals and couples who identify as members of sexual- or gender-minority groups, equitable access to ectogenesis as a pathway to parenthood for sexual and gender minorities must be assured as a matter of reproductive justice.

The ethics of testing and research of manufactured organs on brain-dead/recently deceased subjects.

Over 115 000 people are waiting for life-saving organ transplants, of whom a small fraction will receive transplants and many others will die while waiting. Existing efforts to expand the number of available organs, including increasing the number of registered donors and procuring organs in uncontrolled environments, are crucial but unlikely to address the shortage in the near future and will not improve donor/recipient compatibility or organ quality. If successful, organ bioengineering can solve the shortage and improve functional outcomes. Studying manufactured organs in animal models has produced valuable data, but is not sufficient to understand viability in humans. Before risking manufactured organ experimentation in living humans, study of bioengineered organs in recently deceased humans would facilitate evaluation of the function of engineered tissues and the complex interactions between the host and the transplanted tissue. Although such studies do not pose risk to human subjects, they pose unique ethical challenges concerning the previous wishes of the deceased, rights of surviving family members, effective operation and fair distribution of medical services, and public transparency. This article investigates the ethical, legal and social considerations in performing engineered organ research on the recently deceased.

The Ethics of Psychosocial Assessment in Vascularized Composite Allotransplantation: A Call for Transparency of Process to Support the Equitable Selection of Patients.

As the field of vascularized composite allotransplantation (VCA) continues to evolve and technological approaches improve, VCA programs must focus on promoting greater consistency in psychosocial assessment across programs to support the equitable selection of patients. Based on a summary of published reports of VCA, we address the ethical considerations raised by the present heterogeneity of approaches to psychosocial assessment, including weighing risks and benefits, informed consent and the role of decisional capacity, and potential or perceived bias in the assessment process. We propose transparency of process across the field and encourage VCA programs to work collaboratively to share approaches to psychosocial assessment both pre- and post-transplant to promote health equity.

How to Integrate Lived Experience Into Quality-of-Life Assessment in Patients Considering Facial Transplantation.

Facial transplantation has gained increasing acceptance as a treatment option to improve quality of life (QoL) for persons suffering from severe facial disfigurement. Despite its growth, the field has yet to establish a consistent approach to assessing QoL in face transplant candidates and recipients that includes integration of meaningful patient-reported outcomes. The published literature suggests that face transplant programs currently use a wide variety of assessment tools and strategies. Moreover, confusion remains as to how best to weigh patients' lived experiences and incorporate them into QoL assessments. Qualitative research can illuminate the dimensions of QoL that are meaningful to face transplant candidates and recipients. Coupled with collaboration and data sharing across face transplant programs, qualitative research will help to bring conceptual clarity and transparency to the assessment process.