Richard M. Ruiz M.D.

Gordon, E. J., J. Uriarte, J. Lee, R. Kang, M. Shumate, R. Ruiz, A. K. Mathur, D. P. Ladner and J. C. Caicedo (2021). “Effectiveness of a culturally competent care intervention in reducing disparities in Hispanic live donor kidney transplantation: A hybrid trial.” Am J Transplant. [Epub ahead of print].

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Hispanic patients receive disproportionately fewer living donor kidney transplants (LDKTs) than non-Hispanic Whites (NHW). The Northwestern Medicine Hispanic Kidney Transplant Program (HKTP), designed to increase Hispanic LDKTs, was evaluated as a non-randomized, implementation-effectiveness hybrid trial of patients initiating transplant evaluation at two intervention and two similar control sites. Using a mixed method, observational design, we evaluated the fidelity of the HKTP implementation at the two intervention sites. We tested the impact of the HKTP intervention by evaluating the likelihood of receiving LDKT comparing pre-intervention (1/2011-12/2016) and post-intervention (1/2017-3/2020), across ethnicity and centers. The HKTP study included 2,063 recipients. Intervention Site A exhibited greater implementation fidelity than intervention Site B. For Hispanic recipients at Site A, the likelihood of receiving LDKTs was significantly higher at post-intervention compared to pre-intervention [odds ratio (OR)=3.17 95% confidence interval (1.04, 9.63)], but not at the paired control Site C [OR=1.02 (0.61, 1.71)]. For Hispanic recipients at Site B, the likelihood of receiving a LDKT did not differ between pre- and post-intervention [OR=0.88 (0.40, 1.94)]. The LDKT rate was significantly lower for Hispanics at paired control Site D [OR=0.45 (0.28, 0.90)]. The intervention significantly improved LDKT rates for Hispanic patients at the intervention site that implemented the intervention with greater fidelity.

Johannesson, L., Koon, E.C., Bayer, J., McKenna, G.J., Wall, A., Fernandez, H., Martinez, E.J., Gupta, A., Ruiz, R., Onaca, N. and Testa, G. (2021). “Dallas UtErus Transplant Study: Early Outcomes and Complications of Robot-assisted Hysterectomy for Living Uterus Donors.” Transplantation 105(1): 225-230.

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BACKGROUND: Uterus transplantation is a treatment for absolute uterine infertility and can be performed with living and deceased donors. Given the safety and increased utilization of robotic assistance with other gynecologic and transplant donor operations, we adopted a robot-assisted approach to donor hysterectomy. This study compared early outcomes and morbidity of the robot-assisted approach to donor hysterectomy with the traditionally performed open approach and addressed whether the robot-assisted approach is safe and offers advantages for the donor. METHODS: Our institution has performed 18 living donor hysterectomies for uterus transplantation. This retrospective review compared the last 5 cases utilizing a robot-assisted technique and vaginal extraction of the uterus graft with the first 13 cases performed with an open laparotomy technique. Demographic, intraoperative, and postoperative data were examined. RESULTS: There were no differences between the robot-assisted and the open living donor group with respect to age, body mass index, or gynecological history. Although the median operative time was shorter for the open approach (6.27 versus 10.46 h), the donors’ median estimated blood loss, length of hospital stay, and length of sick leave were less with the robot-assisted approach. There was no conversion to open hysterectomy in the robot-assisted cases, and the incidence of complications was similar between the 2 groups. There was no difference in early graft function. CONCLUSIONS: These preliminary results show that robot-assisted living donor hysterectomy is feasible and safe for the donors; it allows a faster postoperative recovery and the same early graft function.

Testa, G., G. J. McKenna, J. Bayer, A. Wall, H. Fernandez, E. Martinez, A. Gupta, R. Ruiz, N. Onaca, R. T. Gunby, A. R. Gregg, M. Olausson, E. C. Koon and L. Johannesson (2020). “The Evolution of Transplantation From Saving Lives to Fertility Treatment: DUETS (Dallas UtErus Transplant Study).” Ann Surg Jul 9. [Epub ahead of print.].

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OBJECTIVE: We report the results of the first 20 uterus transplants performed in our institution. SUMMARY BACKGROUND DATA: Uterus transplantation (UTx) aims at giving women affected by absolute uterine-factor infertility the possibility of carrying their own pregnancy. UTx has evolved from experimental to an established surgical procedure. METHODS: The Dallas Uterus Transplant Study (DUETS) program started in 2016. The uterus was transplanted in orthotopic position with vascular anastomoses to the external iliac vessels and removed when 1 or 2 live births were achieved. Immunosuppression lasted only for the duration of the uterus graft. RESULTS: Twenty women, median age 29.7 years, enrolled in the study, with 10 in phase 1 and 10 in phase 2. All but 2 recipients had a congenital absence of the uterus. Eighteen recipients received uteri from living donors and 2 from deceased donors. In phase 1, 50% of recipients had a technically successful uterus transplant, compared to 90% in phase 2. Four recipients with a technical success in phase 1 have delivered 1 or 2 babies, and the fifth recipient with a technical success is >30 weeks pregnant. In phase 2, 2 recipients have delivered healthy babies and 5 are pregnant. CONCLUSIONS: UTx is a unique type of transplant; whose only true success is a healthy child birth. Based on results presented here, involving refinement of the surgical technique and donor selection process, UTx is now an established solution for absolute uterine-factor infertility.

DiNorcia, J., S. S. Florman, B. Haydel, P. Tabrizian, R. M. Ruiz, G. B. Klintmalm, S. Senguttuvan, D. D. Lee, C. B. Taner, E. C. Verna, K. J. Halazun, M. Hoteit, M. H. Levine, W. C. Chapman, N. Vachharajani, F. Aucejo, M. H. Nguyen, M. L. Melcher, A. D. Tevar, A. Humar, C. Mobley, M. Ghobrial, T. L. Nydam, B. Amundsen, J. F. Markmann, J. Berumen, A. W. Hemming, A. N. Langnas, C. A. Carney, D. L. Sudan, J. C. Hong, J. Kim, M. A. Zimmerman, A. Rana, M. L. Kueht, C. M. Jones, T. M. Fishbein, D. Markovic, R. W. Busuttil and V. G. Agopian (2020). “Pathologic Response to Pretransplant Locoregional Therapy is Predictive of Patient Outcome After Liver Transplantation for Hepatocellular Carcinoma: Analysis From the US Multicenter HCC Transplant Consortium.” Ann Surg 271(4): 616-624.

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OBJECTIVE: The aim of the study was to determine the rate, predictors, and impact of complete pathologic response (cPR) to pretransplant locoregional therapy (LRT) in a large, multicenter cohort of hepatocellular carcinoma (HCC) patients undergoing liver transplantation (LT). BACKGROUND: LRT is used to mitigate waitlist dropout for patients with HCC awaiting LT. Degree of tumor necrosis found on explant has been associated with recurrence and overall survival, but has not been evaluated in a large, multicenter study. METHODS: Comparisons were made among patients receiving pre-LT LRT with (n = 802) and without (n = 2637) cPR from the United States Multicenter HCC Transplant Consortium (UMHTC), and multivariable predictors of cPR were identified using logistic regression. RESULTS: Of 3439 patients, 802 (23%) had cPR on explant. Compared with patients without cPR, cPR patients were younger; had lower Model for End-stage Liver Disease (MELD) scores, AFP levels, and neutrophil-lymphocyte ratios (NLR); were more likely to have tumors within Milan criteria and fewer LRT treatments; and had significantly lower 1-, 3-, and 5-year incidence of post-LT recurrence (1.3%, 3.5%, and 5.2% vs 6.2%, 13.5%, and 16.4%; P < 0.001) and superior overall survival (92%, 84%, and 75% vs 90%, 78%, and 68%; P < 0.001). Multivariable predictors of cPR included age, sex, liver disease diagnosis, MELD, AFP, NLR, radiographic Milan status, and number of LRT treatments (C-statistic 0.67). CONCLUSIONS: For LT recipients with HCC receiving pretransplant LRT, achieving cPR portends significantly lower posttransplant recurrence and superior survival. Factors predicting cPR are identified, which may help prioritize patients and guide LRT strategies to optimize posttransplant cancer outcomes

Kardashian, A., S. S. Florman, B. Haydel, R. M. Ruiz, G. B. Klintmalm, D. D. Lee, C. B. Taner, F. Aucejo, A. D. Tevar, A. Humar, E. C. Verna, K. J. Halazun, W. C. Chapman, N. Vachharajani, M. Hoteit, M. H. Levine, M. H. Nguyen, M. L. Melcher, A. N. Langnas, C. A. Carney, C. Mobley, M. Ghobrial, B. Amundsen, J. F. Markmann, D. L. Sudan, C. M. Jones, J. Berumen, A. W. Hemming, J. C. Hong, J. Kim, M. A. Zimmerman, T. L. Nydam, A. Rana, M. L. Kueht, T. M. Fishbein, D. Markovic, R. W. Busuttil and V. G. Agopian (2020). “Liver Transplantation Outcomes in a U.S. Multicenter Cohort of 789 Patients with Hepatocellular Carcinoma Presenting Beyond Milan Criteria.” Hepatology Mar 2. [Epub ahead of print].

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The Organ Procurement and Transplantation Network recently approved liver transplant (LT) prioritization for patients with hepatocellular carcinoma (HCC) beyond Milan Criteria (MC) who are downstaged (DS) with locoregional therapy (LRT). We evaluated post-LT outcomes, predictors of downstaging, and the impact of LRT in beyond-MC HCC patients from the US Multicenter HCC Transplant Consortium (20 centers, 2002-2013). Clinicopathologic characteristics, overall survival (OS), recurrence-free survival (RFS), and HCC recurrence (HCC-R) were compared between patients within MC (n=3,570) and beyond MC (n=789) who were downstaged (DS, n=465), treated with LRT and not downstaged (LRT-NoDS, n=242), or untreated (NoLRT-NoDS, n=82). Five-year post-LT OS and RFS was higher in MC (71.3% and 68.2%) compared to DS (64.3% and 59.5%), and lowest in NoDS (n=324; 60.2% and 53.8%; overall P<0.001). DS patients had superior RFS (60% vs 54%,P=0.043) and lower 5-year HCC-R (18% vs 32%,P<0.001) compared to NoDS, with further stratification by maximum radiologic tumor diameter (5-year HCC-R of 15.5% in DS/< 5cm and 39.1% in NoDS/>5cm,P<0.001). Multivariate predictors of downstaging included alpha-fetoprotein response to LRT, pathologic tumor number and size, and wait time >12 months. LRT-NoDS had greater HCC-R compared to NoLRT-NoDS (34.1% vs 26.1%,P<0.001), even after controlling for clinicopathologic variables (HR=2.33,P<0.001) and inverse probability of treatment weighted propensity matching (HR=1.82,P<0.001). Conclusion In LT recipients with HCC presenting beyond MC, successful downstaging is predicted by wait time, alpha-fetoprotein response to LRT, and tumor burden, and results in excellent post-LT outcomes, justifying expansion of LT criteria. In LRT-NoDS patients, higher HCC-R compared to NoLRT-NoDS cannot be explained by clinicopathologic differences, suggesting a potentially aggravating role of LRT in patients with poor tumor biology that warrants further investigation.