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

Laspro, Matteo; Thys, Erika; Chaya, Bachar; Rodriguez, Eduardo D; Kimberly, Laura L
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.
PMID: 38181210
ISSN: 1536-0075
CID: 5678552

Public attitudes to xenotransplantation: A national survey in the United States

Padilla, Luz A; Hurst, Daniel J; Zink, Amanda; Parent, Brendan; Kimberly, Laura L
Xenotransplantation (XTx) presents a potential clinical alternative to the shortage of human organs for transplantation. Before clinical trials occur in the United States, public assessments are crucial to understand potential barriers to acceptance. The purpose of this study was to explore barriers and identify characteristics associated with attitudes toward XTx. A survey assessing demographic characteristics and attitudes toward XTx was distributed to a nationally representative sample of adults aged ≥18 years in the United States. Regression analysis was employed to identify characteristics associated with attitudes toward XTx. Between May 25 and June 14, 2023, 5008 respondents completed the survey. Importantly, half of the respondents expressed low or no knowledge of either transplantation or XTx. Approximately 40% expressed discomfort with receiving a pig organ for themselves or a loved one. Despite a lack of xenotransplant outcome data, 36% were open to experimental XTx if they needed a transplant. However, 57% rated lack of current evidence of success or fear of complications as top concerns. Regression models consistently associated being younger, female, not needing an organ, or being a member of a racial minority group with lower acceptance. This survey is the largest to date exploring public attitudes toward XTx. Despite overall acceptance, concerns persist. Increasing public acceptance is key as the field advances.
PMID: 39053770
ISSN: 1600-6143
CID: 5678572

Older Adults' Lived Experience of Kidney Transplantation

Kimberly, Laura L
BACKGROUND AND OBJECTIVES/OBJECTIVE:The United States is witnessing a rapid increase in kidney transplantation (KTx) among adults aged 65 and over. 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/METHODS:Employing a phenomenological approach, this study explored the lived experiences of 10 KTx recipients aged 65 and over. 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 post-transplant recovery and adaptation period. DISCUSSION AND IMPLICATIONS/CONCLUSIONS: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.
PMID: 36002300
ISSN: 1758-5341
CID: 5338282

Pediatric cardiac xenotransplantation and stakeholder engagement [Letter]

Padilla, Luz A; Hurst, Daniel J; Merlocco, Anthony; Kimberly, Laura; Schiff, Tamar; Parent, Brendan
PMID: 38977242
ISSN: 1600-6143
CID: 5678562

"Facing Violence: The Protective Impact of Facial Gender Affirming Surgery"

Parker, Augustus C; Brydges, Hilliard; Kimberly, Laura; Blasdel, Gaines; Rodriguez, Eduardo D
PMID: 35960918
ISSN: 1529-4242
CID: 5287352

Emerging Ethical Challenges Raised by the Evolution of Vascularized Composite Allotransplantation

Caplan, Arthur L; Parent, Brendan; Kahn, Jeffrey; Dean, Wendy; Kimberly, Laura L; Andrew Lee, W P; Rodriguez, Eduardo D
BACKGROUND:Despite early skepticism, the field of vascularized composite allotransplantation (VCA) has demonstrated feasibility. The ethics of VCA have moved past doubts about the morality of attempting such transplant to how to conduct them ethically. METHODS:Leaders of each program performing and/or evaluating VCA in the United States were invited to participate in a working group to assess the state and future of VCA ethics and policy. Four meetings were held over the course of 1 year to describe key challenges and potential solutions. RESULTS:Working group participants concluded that VCA holds great promise as treatment for patients with particular injuries or deficits, but the field faces unique challenges to adoption as standard of care, which can only be overcome by data sharing and standardization of evaluation and outcome metrics. CONCLUSIONS:Adequate attention must be given to concerns including managing the uniquely intense physician-patient relationship, ethical patient selection, ensuring patients have adequate representation, informing and earning the trust of the public for donation, standardizing metrics for success, and fostering an environment of data sharing. These steps are critical to transitioning VCA from research to standard of care, and to its insurance coverage inclusion.
PMID: 30300280
ISSN: 1534-6080
CID: 3334912

Ethical Issues in Gender-Affirming Care for Youth

Kimberly, Laura L; Folkers, Kelly McBride; Friesen, Phoebe; Sultan, Darren; Quinn, Gwendolyn P; Bateman-House, Alison; Parent, Brendan; Konnoth, Craig; Janssen, Aron; Shah, Lesha D; Bluebond-Langner, Rachel; Salas-Humara, Caroline
Transgender and gender-nonconforming (TGNC) youth who suffer from gender dysphoria are at a substantially elevated risk of numerous adverse physical and psychosocial outcomes compared with their cisgender peers. Innovative treatment options used to support and affirm an individual's preferred gender identity can help resolve gender dysphoria and avoid many negative sequelae of nontreatment. Yet, despite advances in these relatively novel treatment options, which appear to be highly effective in addressing gender dysphoria and mitigating associated adverse outcomes, ethical challenges abound in ensuring that young patients receive appropriate, safe, affordable treatment and that access to this treatment is fair and equitable. Ethical considerations in gender-affirming care for TGNC youth span concerns about meeting the obligations to maximize treatment benefit to patients (beneficence), minimizing harm (nonmaleficence), supporting autonomy for pediatric patients during a time of rapid development, and addressing justice, including equitable access to care for TGNC youth. Moreover, although available data describing the use of gender-affirming treatment options are encouraging, and the risks of not treating TGNC youth with gender dysphoria are evident, little is known about the long-term effects of both hormonal and surgical interventions in this population. To support ethical decision-making about treatment options, we encourage the development of a comprehensive registry in the United States to track long-term patient outcomes. In the meantime, providers who work with TGNC youth and their families should endeavor to offer ethically sound, patient-centered, gender-affirming care based on the best currently available evidence.
PMID: 30401789
ISSN: 1098-4275
CID: 3520072

Navigating the Expanded Access Pathway to Investigational Drugs as an Academic Oncologist

Fernandez Lynch, Holly; Salam, Tasnim; Gould, Patrick; Bateman-House, Alison; Kimberly, Laura
PMCID:9938427
PMID: 36800184
ISSN: 2574-3805
CID: 5421212

Ethical Considerations in Expanding Eligibility Criteria for Uterus Transplant Recipients: A Scoping Review

Thys, Erika; Dave, Nikhil; Kimberly, Laura L
ORIGINAL:0017311
ISSN: 2688-4887
CID: 5678582

Incorporating Trauma-informed Approaches to Care in Vascularized Composite Allotransplantation

Thys, Erika; Laspro, Matteo; Chaya, Bachar F.; Rodriguez, Eduardo D.; Kimberly, Laura L.
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.
SCOPUS:85183935777
ISSN: 2169-7574
CID: 5700282