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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

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.
PMCID:10807881
PMID: 38268713
ISSN: 2169-7574
CID: 5625102

The Use of Virtual Reality in Surgical Training: Implications for Education, Patient Safety, and Global Health Equity

Laspro, Matteo; Groysman, Leya; Verzella, Alexandra N.; Kimberly, Laura L.; Flores, Roberto L.
As medicine becomes more complex, there is pressure for new and more innovative educational methods. Given the economic burden associated with in-person simulation, healthcare, including the realm of surgical education, has begun employing virtual reality (VR). Potential benefits of the addition of VR to surgical learning include increased pre-operative resident exposure to surgical techniques and procedures and better patient safety outcomes. However, these new technological advances, such as VR, may not replicate organic tissues or accurately simulate medical care and surgical scenarios, creating unrealistic pseudo-environments. Similarly, while advancements have been made, there are ongoing disparities concerning the utilization of these technologies. These disparities include aspects such as the availability of stable internet connections and the cost of implementing these technologies. In accordance with other innovative technologies, VR possesses upfront economic costs that may preclude equitable use in different academic centers around the world. As such, VR may further widen educational quality between high- and low-resource nations. This analysis integrates recent innovations in VR technology with existing discourse on global health and surgical equality. In doing so, it offers preliminary guidance to ensure that the implementation of VR occurs in an equitable, safe, and sustainable fashion.
SCOPUS:85180688584
ISSN: 2673-4095
CID: 5630592

The Lived Experience of Pediatric Gene Therapy: A Scoping Review

Kimberly, Laura; Hunt, Cara; Beaverson, Katherine; James, Emma; Bateman-House, Alison; McGowan, Richard; DeSante-Bertkau, Jennifer
Little is known about patients' and families' lived experiences of participating in pediatric gene therapy (GT) clinical trials. Currently, pediatric GT research targets a broad range of indications--including rare and ultra-rare diseases--which vary in severity and in the availability of alternative therapies. Pediatric GT differs meaningfully from adult GT because the decision to participate involves a dyad of both the child and parent or caregiver/s. It is critical to understand patients' and caregivers' perceptions and experiences of social, emotional, physical, and logistical burdens or benefits of participating in such trials, and how they weigh and prioritize these factors when deciding whether to participate. We conducted a scoping review of the current literature in this subject area with objectives to (1) provide an overview of existing literature, (2) identify gaps and areas for further research, and (3) better understand the lived impact of pediatric GT research on patients and their parents/caregivers. Four themes emerged, including (1) weighing risks and benefits (2) timing of GT trial participation, (3) value of clear communication, and (4) potential impact on quality of life. Notably, our sample surfaced articles about how patients/parents/caregivers were thinking about GT-their understanding of its safety, efficacy, and risks-rather than accounts of their experiences, which was our initial intention. Nevertheless, our findings offer useful insights to improve the informed consent process and promote a more patient- and family-centered approach. Moreover, our findings can contribute to patient advocacy organizations' efforts to develop educational materials tailored to patients' and families' expressed informational needs and perspectives, and can inform more patient- and family-centered policies from GT clinical trial sponsors.
PMID: 37964764
ISSN: 1557-7422
CID: 5607822

Gender-affirming hysterectomy in the United States: A comparative outcomes analysis and potential implications for uterine transplantation

Siringo, Nicolette V; Boczar, Daniel; Berman, Zoe P; Chaya, Bachar F; Kimberly, Laura; Rodriguez Colon, Ricardo; Trilles, Jorge; Brydges, Hilliard; Rodriguez, Eduardo D
PURPOSE/OBJECTIVE:Hysterectomy is a gynecological procedure sometimes performed as part of the gender-affirming process for transgender and gender-expansive patients assigned female at birth. Our goal was to compare surgical outcomes between patients undergoing gender-affirming hysterectomy and patients undergoing hysterectomy for benign menstrual disorders. We then explored the implications of gender-affirming hysterectomy for uterine transplantation. METHODS:We performed a retrospective cohort study using data from the American College of Surgeons National Surgical Quality Improvement Program database from 2009 through 2018. We identified patients undergoing hysterectomy in the United States based on Current Procedural Terminology code. We used the International Classification of Diseases 9 or 10 codes to identify patients with benign menstrual disorders (non-gender-affirming group) and gender dysphoria (gender-affirming group). We compared patient characteristics and surgical complications. RESULTS:Of the 40,742 patients that met inclusion criteria, 526 (1.3%) patients were individuals with gender dysphoria. Compared to patients who underwent hysterectomy for benign menstrual disorders, gender-affirming patients were younger, were healthier, had a lower prevalence of diabetes, and were more likely to undergo surgery in the outpatient setting, with shorter time to discharge. Complication rates were similar between groups. Logistic regression controlling for the American Society of Anesthesiology classification determined the difference of return to the operating room was not statistically significant (OR 1.082; 95% CI, 0.56-2.10; p = 0.816). CONCLUSION/CONCLUSIONS:Gender-affirming hysterectomy has a safety profile similar to hysterectomy performed for benign menstrual disorders. Researchers should further explore the possibility of uterus donation among these patients as they may be suitable candidates.
PMID: 37923702
ISSN: 1931-2393
CID: 5607692

Should BMI Help Determine Gender-Affirming Surgery Candidacy?

Castle, Elijah; Kimberly, Laura; Blasdel, Gaines; Parker, Augustus; Bluebond-Langner, Rachel; Zhao, Lee C
Use of body mass index (BMI) as a health care metric is controversial, especially in candidacy assessments for gender-affirming surgery. When considering experiences of fat trans individuals, it is important to advocate for equitable divisions of responsibility for and recognition of systemic fat phobia. This commentary on a case suggests strategies for increasing equitable access to safe surgery for all body types. If surgeons use BMI thresholds, simultaneous effort must be made to advocate for data collection so that surgical candidacy criteria are evidence-based and equitably applied.
PMID: 37432002
ISSN: 2376-6980
CID: 5537012

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

Toward a Broader Conception of Equity in Artificial Womb Technology [Comment]

Kimberly, Laura L; Quinn, Gwendolyn P
PMID: 37130388
ISSN: 1536-0075
CID: 5503002

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

Laspro, Matteo; Chaya, Bachar F; Brydges, Hilliard T; Dave, Nikhil; Thys, Erika; Onuh, Ogechukwu C; Tran, David; Kimberly, Laura L; Ceradini, Daniel J; Rodriguez, Eduardo D
UNLABELLED: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/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED: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.
PMCID:10129168
PMID: 37113307
ISSN: 2169-7574
CID: 5465502

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