Giuliano Testa M.D.

Testa, G. and L. Johannesson (2020). “Commentary on “Live Birth Following Uterine Transplantation from a Nulliparous Deceased Donor”.” Transplantation Jun 9. [Epub ahead of print.].

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Uterus transplantation (UTx), with less than 100 transplants performed worldwide, is a fertility treatment that has the potential to help thousands of women affected by absolute uterinefactor infertility experience gestation and childbirth.The article by Fronek et al in Transplantation reports a live birth from a mother who had received a uterus from a nulliparous deceased donor. The report provides valuable information that may change the previous praxis of not using uterine grafts from nulliparous donors in UTx and thereby may increase organ availability. Among the 20 reported live births after UTx, only 3, including the one reported in this issue, have occurred from deceased donors, and in the 2 preceding cases the deceased donor had at least 1 proven pregnancy and delivery. [No abstract available; excerpt from article.].

Roth, A. E., I. R. Marino, O. Ekwenna, T. B. Dunn, S. R. Paloyo, M. Tan, R. Correa-Rotter, C. S. Kuhr, C. L. Marsh, J. Ortiz, G. Testa, P. Sindhwani, D. L. Segev, J. Rogers, J. D. Punch, R. C. Forbes, M. A. Zimmerman, M. J. Ellis, A. Rege, L. Basagoitia, K. D. Krawiec and M. A. Rees (2020). “Global Kidney Exchange Should Expand Wisely.” Transpl Int May 20. [Epub ahead of print].

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We read with great interest and appreciation the careful consideration and analysis by Ambagtsheer et al. of the most critical ethical objections to Global Kidney Exchange (GKE). Ambagtsheer et al. conclude that implementation of GKE is a means to increase access to transplantation ethically and effectively.(1,2) These conclusions by their European Society of Transplantation (ESOT) committee on Ethical, Legal and Psychological Aspects of Transplantation (ELPAT) represent a step forward toward a greater understanding and an open, honest debate about GKE.

Johannesson, L., G. Testa, R. Flyckt, R. Farrell, C. Quintini, A. Wall, K. O’Neill, A. Tzakis, E. G. Richards, S. M. Gordon and P. M. Porrett (2020). “Guidelines for standardized nomenclature and reporting in uterus transplantation: An opinion from the United States Uterus Transplant Consortium.” Am J Transplant May 7. [Epub ahead of print].

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Uterus transplantation is a nascent but growing field. To support this growth, the United States Uterus Transplant Consortium proposes guidelines for nomenclature related to operative technique, vascular anatomy, and donor, recipient, and offspring outcomes. In terms of anatomy, the group recommends reporting donor arterial inflow and recipient anastomotic site delivering inflow to the graft and offers standardization of the names for the 4 veins originating from the uterus because of current inconsistency in this particular nomenclature. Seven progressive stages with milestones of success are defined for reporting on uterus transplantation outcomes: (1) technical, (2) menstruation, (3) embryo implantation, (4) pregnancy, (5) delivery, (6) graft removal, and (7) long-term follow-up. The 3 primary metrics for success are recipient survival (as reported for other organ transplant recipients), graft survival, and uterus transplant live birth rate (defined as live birth per transplanted recipient). A number of secondary outcomes should also be reported, most of which capture stage-specific milestones, as well as data on graft failure. Outcome metrics for living donors include patient survival, survival free of operative intervention, and data on complications and hospitalizations. Finally, we make specific recommendations on follow-up for offspring born from uterine grafts, which includes specialty surveillance as well as collection and reporting of routine pediatric outcomes. The goal of standardization in reporting is to create consistency and improve the quality of evidence available on the efficacy and value of the procedure.

Wall, A. E., T. Pruett, P. Stock and G. Testa (2020). “Coronavirus disease 2019: Utilizing an ethical framework for rationing absolutely scarce health-care resources in transplant allocation decisions.” Am J Transplant Apr 13. [Epub ahead of print].

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The novel Coronavirus disease 2019 (COVID-19) is impacting transplant programs around the world, and, as the center of the pandemic shifts to the United States, we have to prepare to make decisions about which patients to transplant during times of constrained resources. In this paper, we discuss how to transition from the traditional justice vs utility consideration in organ allocation to a more nuanced allocation scheme based on ethical values that drive decisions in times of absolute scarcity. We recognize that many decisions are made based on the practical limitations that transplant programs face, especially at the extremes. As programs make the transition from a standard approach to a resource-constrained approach to transplantation, we utilize a framework for ethical decisions in settings of absolutely scarce resources to help guide programs in deciding which patients to transplant, which donors to accept, how to minimize risk, and how to ensure the best utilization of transplant team members.

Asrani, S. K., L. W. Jennings, W. R. Kim, P. S. Kamath, J. Levitsky, M. K. Nadim, G. Testa, M. D. Leise, J. F. Trotter and G. Klintmalm (2020). “MELD-GRAIL-Na: Glomerular Filtration Rate and Mortality on Liver-Transplant Waiting List.” Hepatology 71(5): 1766-1774.

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BACKGROUND AND AIMS: Among patients with cirrhosis awaiting liver transplantation, prediction of wait-list (WL) mortality is adjudicated by the Model for End Stage Liver Disease-Sodium (MELD-Na) score. Replacing serum creatinine (SCr) with estimated glomerular filtration rate (eGFR) in the MELD-Na score may improve prediction of WL mortality, especially for women and highest disease severity. APPROACH AND RESULTS: We developed (2014) and validated (2015) a model incorporating eGFR using national data (n = 17,095) to predict WL mortality. Glomerular filtration rate (GFR) was estimated using the GFR assessment in liver disease (GRAIL) developed among patients with cirrhosis. Multivariate Cox proportional hazard analysis models were used to compare the predicted 90-day WL mortality between MELD-GRAIL-Na (re-estimated bilirubin, international normalized ratio [INR], sodium, and GRAIL) versus MELD-Na. Within 3 months, 27.8% were transplanted, 4.3% died on the WL, and 4.7% were delisted for other reasons. GFR as estimated by GRAIL (hazard ratio [HR] 0.382, 95% confidence interval [CI] 0.344-0.424) and the re-estimated model MELD-GRAIL-Na (HR 1.212, 95% CI 1.199-1.224) were significant predictors of mortality or being delisted on the WL within 3 months. MELD-GRAIL-Na was a better predictor of observed mortality at highest deciles of disease severity (>/= 27-40). For a score of 32 or higher (observed mortality 0.68), predicted mortality was 0.67 (MELD-GRAIL-Na) and 0.51 (MELD-Na). For women, a score of 32 or higher (observed mortality 0.67), the predicted mortality was 0.69 (MELD-GRAIL-Na) and 0.55 (MELD-Na). In 2015, use of MELD-GRAIL-Na as compared with MELD-Na resulted in reclassification of 16.7% (n = 672) of patients on the WL. CONCLUSION: Incorporation of eGFR likely captures true GFR better than SCr, especially among women. Incorporation of MELD-GRAIL-Na instead of MELD-Na may affect outcomes for 12%-17% awaiting transplant and affect organ allocation.