Vascularized Composite Allograft Transplantation in the United States: Current State of the Field and Future Challenges : Transplantation

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Vascularized Composite Allograft Transplantation in the United States: Current State of the Field and Future Challenges

Wainright, Jennifer L. PhD1; Booker, Sarah E. MPH1; Cherikh, Wida S. PhD1; Klassen, David K. MD2

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doi: 10.1097/TP.0000000000004135
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INTRODUCTION

Vascularized composite allograft (VCA) transplants in the United States include organs that meet the criteria in the Organ Procurement and Transplantation Network (OPTN) Final Rule.1 These organs include the upper limb, face, scalp, abdominal wall, penis, larynx, trachea, and uterus. The OPTN was granted oversight of VCA transplants and, on July 3, 2014, implemented national VCA transplant policies and created a national VCA waiting list, on which all VCA candidates must be registered.2-4 VCA organs are offered first to candidates within 500 nautical miles of the donor hospital, then to candidates beyond that circle, with candidates within those classifications ranked by waiting time.5 The field has grown and changed since the first VCA transplant occurred in the United States in 1998,6,7 encountering numerous challenges that include scarce funding sources and effects of the coronavirus disease 2019 (COVID-19) pandemic on transplantation.

VCA TRENDS

Between July 3, 2014, and December 31, 2021, 105 VCA candidates were added to the waiting list—47 uterus, 26 upper limb (14 bilateral, 12 unilateral), 1 bilateral upper limb and face, 12 face, 1 scalp, 2 face with scalp, 1 trachea, 12 abdominal wall, and 3 penis candidates (Figure 1A and B; Supplemental Information, SDC, https://links.lww.com/TP/C401). Additions increased in 2016 after the introduction of uterus and penis transplants in the United States. Additions for head and neck (including face, scalp, trachea, and face with scalp) and upper limb held relatively steady through 2019.

F1
FIGURE 1.:
A and B, VCA candidates in the United States (July 3, 2014–December 31, 2021). OPTN, Organ Procurement and Transplantation Network; UL, upper limb; VCA, vascularized composite allograft.

The COVID-19 pandemic resulted in a decrease in VCA waiting list additions in 2020—only 1 abdominal wall, 1 uterus, and 2 upper limb candidates. Transplant programs added 5 VCA candidates—2 abdominal wall and 3 uterus candidates—to the waiting list in 2021. At the height of the pandemic’s effect on transplantation in April 2020, 11 of 23 VCA candidates were inactive on the waiting list, which means that the candidate would not receive organ offers until their program reactivated them. As of December 31, 2021, 8 of 20 VCA candidates were inactive.

Of 105 candidates, 62 have received 64 transplants (including 1 uterus retransplant and 1 combined face and bilateral upper limb transplant). Others refused transplant (n = 7), became ineligible (n = 4), could not be contacted (n = 2), had condition improvement (n = 1), were too sick for transplant (n = 2), died (n = 3), or were removed for other reasons (n = 3). The median time on the waiting list for those transplanted was 217 d (interquartile range, 76.0–404.25 d).

VCA transplants in the United States between July 3, 2014, and December 31, 2021, included 14 upper limb (9 bilateral; 5 unilateral), 9 face, 1 bilateral upper limb with face, 1 scalp, 1 trachea, 2 abdominal wall, 2 penis, and 33 uterus transplants (12 deceased donors; 21 living donors; Figure 2A). After uterus transplantation began in the United States in 2016, VCA transplantation shifted from mostly upper limb and face transplants to a larger proportion of uterus transplants (Figure 2B). Upper limb and face transplants decreased in 2017, then increased and held steady through 2019.

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FIGURE 2.:
A and B, VCA transplants in the United States (July 3, 2014–December 31, 2021). UL, upper limb; VCA, vascularized composite allograft.

VCA transplants decreased in 2020 with the beginning of the COVID-19 crisis and included 2 uterus transplants, the first US face retransplant, and the first successful combined bilateral upper limb and face transplant in the United States. In 2021, transplant programs performed 2 living donor uterus transplants, 1 bilateral upper limb transplant, and the first trachea transplant in the United States.

Outcomes for VCA transplants in the United States have been very successful. Transplant programs have reported to the OPTN 21 live births to 19 recipients of uterus transplant. The 8 reported uterus graft failures of 33 transplants were observed largely among the earliest uterus transplants performed in the United States, showing improvement in outcomes as this new field gained knowledge and experience. Very few graft losses have been reported for post-July 2014 transplants of other VCA organs: 1 of 15 upper limb (6.7%), 0 of 12 head and neck, 0 of 2 abdominal wall, and 0 of 2 of penis transplants.

FUTURE CHALLENGES AND CONCLUSIONS

VCA transplantation has several challenges to overcome to continue to expand access to more patients and be accepted as standard-of-care treatment. The most acute challenge to the field is the continued pressure the COVID-19 pandemic has placed on hospitals. With numerous programs placing some or all of their VCA candidates into inactive status, the momentum that had been building through 2019 will need to be rebuilt. This work will include the process of evaluating potential candidates and renewing and strengthening relationships with local organ procurement organizations.2,8,9

A more chronic challenge to the field that needs to be resolved is funding. Out of 62 VCA transplant recipients in the United States since July 2014, 21 received free care (ie, the transplant hospital will not charge recipient for the costs of the transplant operation), and 15 were funded by donations, 7 by Medicare or Medicaid, 1 by the Department of Veterans Affairs, and 3 by private insurance. The 2 uterus transplants in 2021 were funded by the recipients, demonstrating the potential of a future funding source for uterus transplants.

Looking at specific VCA organ types, 26 of 33 uterus transplants were free care/donations, and 2 were funded by the recipient; funding source has not yet been reported for 5 uterus transplants. Five of 11 head and neck transplants since July 2014 were free care/donations, 3 were funded by Medicare/Medicaid, and 2 were funded by private insurance; funding source has not yet been reported for 1 head and neck transplant. Since July 2014, 4 upper limb transplants were free care/donations, 1 was funded by Medicare/Medicaid, and 1 was funded by private insurance; funding source has not yet been reported for 7 upper limb transplants. Of the 2 abdominal wall transplants since July 2014, which in the United States have been performed as part of multi-visceral transplants (ie, liver, pancreas, and/or intestine), both were funded by Medicare/Medicaid.

The relatively new field of VCA transplantation was in a period of rapid transition and growth through 2019, with a large increase in uterus transplantation beginning in 2016. The exciting introduction of uterus transplantation introduced new considerations to the field. It is the first organ type intended to be a temporary transplant for the recipient, giving the benefits—a live birth—without the burden of lifetime use of immunosuppressant drugs. The COVID-19 pandemic brought the field to a near standstill during the height of the crisis, with few new listings, active candidates, or transplants in 2020 and a greatly reduced volume in 2021. Continuing questions about funding sources remain a concern, with many VCA transplants still funded by the institution, but recent developments in uterus transplantation suggest the potential for recipient-funded transplants. Despite challenges such as the COVID-19 pandemic and chronic issues such as funding sources, VCA transplantation has shown signs of resilience and growth in 2021, the first successful combined face and upper limb transplant in the United States and the first trachea transplant, and the field has strong potential to regain its momentum.

ACKNOWLEDGMENTS

This work was conducted under the auspices of the United Network for Organ Sharing, the contractor for the OPTN (US Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation).

REFERENCES

1. OPTN Final Rule 42 CFR §121.2. 2013.
2. McDiarmid SV. Donor and procurement related issues in vascularized composite allograft transplantation. Curr Opin Organ Transplant. 2013;18:665–671.
3. Glazier AK. Regulatory oversight in the United States of vascularized composite allografts. Transpl Int. 2016;29:682–685.
4. OPTN Policy 3.4.C Candidate Registrations.
5. OPTN Policy 12.2 VCA Allocation.
6. Wainright JL, Wholley CL, Cherikh WS, et al. OPTN vascularized composite allograft waiting list: current status and trends in the United States. Transplantation. 2018;102:1885–1890.
7. Cherikh WS, Cendales LC, Wholley CL, et al. Vascularized composite allotransplantation in the United States: a descriptive analysis of the Organ Procurement and Transplantation Network data. Am J Transplant. 2019;19:865–875.
8. Wainright JL, Wholley CL, Rosendale J, et al. VCA deceased donors in the United States. Transplantation. 2019;103:990–997.
9. Vece GR, Robinson A, Rosendale J, et al. Maximizing donors’ gifts: a comparison of actual and expected solid organ yield among VCA donors. Am J Transplant. 2021;21:1263–1268.

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