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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

Vascularized Composite Allotransplantation: Alternatives and Catch-22s

Diaz-Siso, J Rodrigo; Borab, Zachary M; Plana, Natalie M; Parent, Brendan; Stranix, John T; Rodriguez, Eduardo D
Technical success has been achieved in several forms of vascularized composite allotransplantation, including hand, face, penis, and lower extremity. However, the risks of lifelong immunosuppression have limited these procedures to a select group of patients for whom nontransplant alternatives have resulted in unsatisfactory outcomes. Recent reports of facial allograft failure, and subsequent reconstruction using autologous tissues, have reinforced the idea that a surgical contingency plan must be in place in case this devastating complication occurs. Interestingly, backup plans in the setting of vascularized composite allotransplantation consist of the nontransplant alternatives that were deemed suboptimal in the first place. Moreover, these options may have been exhausted before transplantation, and may therefore be limited in the case of allograft loss or reamputation. In this article, the authors describe the surgical and nonsurgical alternatives to hand, face, penis, and lower extremity transplantation. In addition, the authors explore the ethical implications of approaching vascularized composite allotransplantation as a "last resort" or as a "high-risk, improved-outcome" procedure, focusing on whether nontransplant options eventually preclude vascularized composite allotransplantation, or whether vascularized composite allotransplantation limits future nontransplant reconstruction.
PMID: 30511987
ISSN: 1529-4242
CID: 3520282

Free Ulnar Forearm Flap: Design, Elevation, and Utility in Microvascular Nasal Lining Reconstruction

Kantar, Rami S; Rifkin, William J; Cammarata, Michael J; Diaz-Siso, J Rodrigo; Farber, Scott J; Rodriguez, Eduardo D
Reconstruction of the nasal lining has traditionally been performed using the folded radial forearm free flap, given its reliable blood supply, pliability, and familiarity to surgeons with respect to its harvest. More recently, the free ulnar forearm flap has been proposed as an alternative reconstructive option for the nasal lining, with safe and reliable outcomes, and improved donor-site morbidity compared with its radial counterpart. In this article, the authors provide educational video footage with accompanying text description of the senior author's (E.D.R) approach to design and elevation of the free ulnar forearm flap for the purpose of reconstructing a composite nasal defect. CLINICAL QUESTION/LEVEL OF EVIDENCE:: Therapeutic, V.
PMID: 30489533
ISSN: 1529-4242
CID: 3500682

Appraisal of the Free Ulnar Flap Versatility in Craniofacial Soft-tissue Reconstruction

Kantar, Rami S; Rifkin, William J; Cammarata, Michael J; Jacoby, Adam; Farber, Scott J; Diaz-Siso, J Rodrigo; Ceradini, Daniel J; Rodriguez, Eduardo D
The unique anatomical characteristics of the forearm region make it especially popular as a free flap donor site for craniofacial soft-tissue reconstruction. The free ulnar forearm flap is less hirsute and allows for better concealment of donor site scar as compared with its radial counterpart. Despite these factors, the free radial forearm flap remains more popular among reconstructive surgeons. Through the presented case series, we hope to emphasize the versatile nature of the free ulnar forearm flap in addressing various craniofacial soft-tissue defects. Following institutional review board approval, a retrospective review of the senior authors' clinical experience performing microvascular free ulnar forearm flap reconstruction of craniofacial soft-tissue defects was performed. A total of 10 patients were identified through our review. Soft-tissue defect locations included lower eyelid (n = 2), tongue and floor of mouth (n = 2), lower lip (n = 2), palatopharyngeal area (n = 1), nose (n = 1), and palate (n = 1). Trauma was the most common defect etiology (n = 5), followed by malignancy (n = 4), and iatrogenic injury in 1 case. All patients demonstrated good aesthetic and functional outcomes related to vision, speech, and oral intake at follow-up when applicable. The free ulnar forearm flap is a versatile reconstructive option that can be used to address a wide spectrum of craniofacial soft-tissue defects and offers numerous advantages over its radial counterpart.
PMID: 30349774
ISSN: 2169-7574
CID: 3384452

Long-distance care of face transplant recipients in the United States

Rifkin, William J; Manjunath, Amit; Kimberly, Laura L; Plana, Natalie M; Kantar, Rami S; Bernstein, G Leslie; Diaz-Siso, J Rodrigo; Rodriguez, Eduardo D
Promising aesthetic and functional outcomes in facial transplantation have fueled the interest of patients and providers alike. However, there are currently only 11 active face transplant centers in the United States, and only five have accumulated operative experience to date, resulting in an extremely unbalanced geographical distribution of providers. Since face transplant recipients must receive life-long follow-up, this presents unique challenges for face transplant candidates and provider teams, as long-distance travel may add considerable difficulty to pre- and post-transplant care. Furthermore, by compromising follow-up, this burden of travel may impact the ability of experienced face transplant centers to collect data, share knowledge as these patients are followed, and continue to advance the field. This article highlights the unique logistical and ethical implications of the highly probable long-distance nature of face transplant care in the United States, a challenging aspect of management that has not been previously discussed in the literature. Furthermore, we review current strategies in the long-distance management of solid organ transplantation (SOT) recipients, and propose several possibilities to help address these challenges in facial transplantation based on SOT experience.
PMID: 30244707
ISSN: 1878-0539
CID: 3314892

Ethics, Culture, and Education: The Human Side of Facial Transplantation

Plana, Natalie M; Diaz-Siso, J Rodrigo; Rodriguez, Eduardo D
PMID: 30048371
ISSN: 1529-4242
CID: 3216532

Facial Transplantation: Highlighting the Importance of Clinical Vigilance in Donor Selection

Kantar, Rami S; Gelb, Bruce E; Hazen, Alexes; Rodriguez, Eduardo D
PMID: 30044325
ISSN: 1529-4242
CID: 3216442

Absence of Rejection in a Facial Allograft Recipient with a Positive Flow Crossmatch 24 Months after Induction with Rabbit Anti-Thymocyte Globulin and Anti-CD20 Monoclonal Antibody

Gelb, Bruce E; Diaz-Siso, J Rodrigo; Plana, Natalie M; Jacoby, Adam; Rifkin, William J; Khouri, Kimberly S; Ceradini, Daniel J; Rodriguez, Eduardo D
Background/UNASSIGNED:Donor-specific antibodies (DSA) to human leukocyte antigen increase the risk of accelerated rejection and allograft damage and reduce the likelihood of successful transplantation. Patients with full-thickness facial burns may benefit from facial allotransplantation. However, they are at a high risk of developing DSA due to standard features of their acute care. Case Presentation/UNASSIGNED:A 41-year-old male with severe disfigurement from facial burns consented to facial allotransplantation in 2014; panel reactive antibody score was 0%. In August of 2015, a suitable donor was found. Complement-dependent cytotoxicity crossmatch was negative; flow cytometry crossmatch was positive to donor B cells. An induction immunosuppression strategy consisting of rabbit antithymocyte globulin, rituximab, tacrolimus, mycophenolate mofetil (MMF), and methylprednisolone taper was designed. Total face, scalp, eyelid, ears, and skeletal subunit allotransplantation was performed without operative, immunological, or infectious complications. Maintenance immunosuppression consists of tacrolimus, MMF, and prednisone. As of posttransplant month 24, the patient has not developed acute rejection or metabolic or infectious complications. Conclusions/UNASSIGNED:To our knowledge, this is the first report of targeted B cell agents used for induction immunosuppression in skin-containing vascularized composite tissue allotransplantation. A cautious approach is warranted, but early results are promising for reconstructive transplant candidates given the exceptionally high rate of acute rejection episodes, particularly in the first year, in this patient population.
PMCID:5985128
PMID: 29888023
ISSN: 2090-6943
CID: 3154932

Face of the Future: Lessons Learned and Opportunities in Composite Allotransplantation

Kantar, Rami S; Diaz-Siso, J Rodrigo; Rodriguez, Eduardo D
PMID: 29771837
ISSN: 1536-3732
CID: 3121482

Face Transplantation: An Update for the United States Trauma System

Farber, Scott J; Kantar, Rami S; Diaz-Siso, J Rodrigo; Rodriguez, Eduardo D
Face transplantation has evolved over the last 12 years into a safe and feasible reconstructive solution, with good aesthetic and functional outcomes for patients with severe facial defects who are not amenable to reconstruction through conventional and autologous approaches. Among patients who underwent face transplantation to date, a significant proportion did so following trauma, mostly ballistic and thermal injuries. It is therefore important for trauma surgeons who deal with these injuries regularly to be familiar with the literature on face transplantation following traumatic injuries. In this study, we provide a focused review on this topic, with an emphasis on highlighting the limitations of conventional craniomaxillofacial reconstruction, while emphasizing data available on the risks, benefits, surgical indications, contraindications, as well as aesthetic and functional outcomes of face transplantation. The authors also provide an update on all face transplants performed to date including traumatic mechanisms of injury, and extent of defects. They finally describe 2 cases performed by the senior author for patients presenting with devastating facial ballistic and thermal injuries. The authors hope that this work serves as an update for the trauma surgery community regarding the current role and limitations of face transplantation as a craniomaxillofacial reconstructive option for their patient population. This can potentially expedite the reconstructive process for patients who may benefit from face transplantation.
PMID: 29771838
ISSN: 1536-3732
CID: 3121492