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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
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 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
Social support criteria in vascularized composite allotransplantation versus solid organ transplantation: Should the same ethical considerations apply?
Kimberly, Laura L; Onuh, Ogechukwu C; Thys, Erika; Rodriguez, Eduardo D
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.
PMCID:9723137
PMID: 36483709
ISSN: 1664-1078
CID: 5383192
Early Steps of the Kidney Transplant Process: What Are the Experiences of Dialysis Social Workers?
Levan, Macey L; Kaplow, Katya; Downey, Max C; Sidoti, Carolyn N; Reed, Rhiannon D; Richards, Kristy; Liebman, Scott E; Gordon, Elisa J; Rudow, Dianne LaPointe; Segev, Dorry L; Kayler, Liise K; Lindower, Carrie; Kimberly, Laura L
INTRODUCTION/BACKGROUND:Dialysis social workers (DSWs) educate and advocate for end-stage kidney disease (ESKD) patients during the kidney transplantation (KT) process. However, little is known about the barriers DSWs face as they help patients get waitlisted and how to best support their efforts. We interviewed DSWs across New York (NY) State to examine their experiences, supports, and challenges in helping dialysis patients progress through KT education, referral, and evaluation. METHODS:We conducted semi-structured interviews with DSWs in NY State who had participated or expressed interest in a program designed to educate DSWs about KT and used rapid qualitative analysis to identify themes. FINDINGS/RESULTS:We interviewed 17 DSWs. Seven themes emerged: (1) DSWs report involvement in KT interest assessment, education, referral, and evaluation support, (2) DSWs report varying nephrologist support in helping patients progress to KT, (3) DSWs perceive social support and adherence as key factors in KT centers' eligibility determinations, (4) DSWs have knowledge gaps around living donation and appreciate learning about KT from transplant centers and non-profit organizations, (5) Patients express KT concerns and DSWs counsel them about these concerns, (6) DSWs report solutions to help patients complete KT evaluation appointments, and (7) DSWs report communication deficiencies between dialysis centers and transplant centers, and patients. CONCLUSIONS:Education for DSWs, support from nephrologists, and resources to help patients complete KT evaluation steps facilitated DSW engagement throughout the pre-transplant process, underscoring the need for multi-level, cross-disciplinary programs to support these efforts.
PMID: 40391920
ISSN: 1399-0012
CID: 5852962
Establishing Research Priorities in Geriatric Nephrology: A Delphi Study of Clinicians and Researchers
Butler, Catherine R; Nalatwad, Akanksha; Cheung, Katharine L; Hannan, Mary F; Hladek, Melissa D; Johnston, Emily A; Kimberly, Laura; Liu, Christine K; Nair, Devika; Ozdemir, Semra; Saeed, Fahad; Scherer, Jennifer S; Segev, Dorry L; Sheshadri, Anoop; Tennankore, Karthik K; Washington, Tiffany R; Wolfgram, Dawn; Ghildayal, Nidhi; Hall, Rasheeda; McAdams-DeMarco, Mara
RATIONALE & OBJECTIVE/OBJECTIVE:Despite substantial growth in the population of older adults with kidney disease, there remains a lack of evidence to guide clinical care for this group. The Kidney Disease and Aging Research Collaborative (KDARC) conducted a Delphi study to build consensus on research priorities for clinical geriatric nephrology. STUDY DESIGN/METHODS:Asynchronous modified Delphi study. SETTING & PARTICIPANTS/METHODS:Clinicians and researchers in the US and Canada with clinical experience and/or research expertise in geriatric nephrology. OUTCOME/RESULTS:Research priorities in geriatric nephrology. ANALYTICAL APPROACH/METHODS:In the first Delphi round, participants submitted free-text descriptions of research priorities considered important for improving the clinical care of older adults with kidney disease. Delphi moderators used inductive content analysis to group concepts into categories. In the second and third rounds, participants iteratively reviewed topics, selected their top 5 priorities, and offered comments used to revise categories. RESULTS:Among 121 who were invited, 57 participants (47%) completed the first Delphi round and 48 (84% of enrolled participants) completed all rounds. After 3 rounds, the 5 priorities with the highest proportion of agreement were: 1) Communication and Decision-Making about Treatment Options for Older Adults with Kidney Failure (69% agreement), 2) Quality of Life, Symptom Management, and Palliative Care (67%), 3) Frailty and Physical Function (54%), 4) Tailoring Therapies for Kidney Disease to Specific Needs of Older Adults (42%), and 5) Caregiver and Social Support (35%). Health equity and person-centricity were identified as cross-cutting features that informed all topics. LIMITATIONS/CONCLUSIONS:Relatively low response rate and limited participation by private practitioners and older clinicians and researchers. CONCLUSIONS:Experts in geriatric nephrology identified clinical research priorities with the greatest potential to improve care for older adults with kidney disease. These findings provide a roadmap for the geriatric nephrology community to harmonize and maximize the impact of research efforts.
PMID: 39603330
ISSN: 1523-6838
CID: 5759122
The Modified Frailty 5-Factor Index Predicts Adverse Outcomes After Ventral Hernia Repair in a National Database
Diaz, Allison L; Lee, Wen-Yu; Oh, Cheongeun; Kimberly, Laura L
BACKGROUND/UNASSIGNED:Ventral hernia repair (VHR) is a common procedure performed on a comorbid patient population at risk for complications, necessitating effective preoperative risk assessment. Previous research suggests that frailty better predicts adverse outcomes compared with historical risk proxies including age. We examined the association between frailty as measured by the 5-factor modified frailty index and postoperative complications following VHR as reported in the National Surgical Quality Improvement Program database. METHODS/UNASSIGNED:value less than 0.05 was considered statistically significant. RESULTS/UNASSIGNED:A total of 14,575 patients were identified. Frailty was a significant predictor of all-cause complications, readmission, reoperation, and increasing length of stay. Increased age was a significant predictor for length of stay and severe systemic complications. Smoking status and American Society of Anesthesiologists class of 4 were associated with all outcomes. Body mass index predicted surgical site complications and reoperation. CONCLUSIONS/UNASSIGNED:Frailty can predict many postoperative complications of VHR with component separation technique and is an important element of risk prediction for potential surgical candidates.
PMCID:11730838
PMID: 39810906
ISSN: 2169-7574
CID: 5775782