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. 2024 Jul 18:74:102737.
doi: 10.1016/j.eclinm.2024.102737. eCollection 2024 Aug.

GEMA-Na and MELD 3.0 severity scores to address sex disparities for accessing liver transplantation: a nationwide retrospective cohort study

Manuel Luis Rodríguez-Perálvarez  1   2 , Gloria de la Rosa  3 , Antonio Manuel Gómez-Orellana  4 , María Victoria Aguilera  2   5 , Teresa Pascual Vicente  6 , Sheila Pereira  7 , María Luisa Ortiz  8 , Giulia Pagano  2   9 , Francisco Suarez  10 , Rocío González Grande  11 , Alba Cachero  12 , Santiago Tomé  13 , Mónica Barreales  14 , Rosa Martín Mateos  2   15 , Sonia Pascual  2   16 , Mario Romero  2   17 , Itxarone Bilbao  2   18 , Carmen Alonso Martín  19 , Elena Otón  20 , Luisa González Diéguez  21 , María Dolores Espinosa  22 , Ana Arias Milla  23 , Gerardo Blanco Fernández  24 , Sara Lorente  25 , Antonio Cuadrado Lavín  26 , Amaya Redín García  2   27 , Clara Sánchez Cano  2   5 , Carmen Cepeda-Franco  7 , José Antonio Pons  8 , Jordi Colmenero  2   9 , David Guijo-Rubio  4   28 , Alejandra Otero  10 , Alberto Amador Navarrete  12 , Sarai Romero Moreno  2   5 , María Rodríguez Soler  2   16 , César Hervás Martínez  4 , Mikel Gastaca  6
Affiliations

GEMA-Na and MELD 3.0 severity scores to address sex disparities for accessing liver transplantation: a nationwide retrospective cohort study

Manuel Luis Rodríguez-Perálvarez et al. EClinicalMedicine. .

Abstract

Background: The Gender-Equity Model for liver Allocation corrected by serum sodium (GEMA-Na) and the Model for End-stage Liver Disease 3.0 (MELD 3.0) could amend sex disparities for accessing liver transplantation (LT). We aimed to assess these inequities in Spain and to compare the performance of GEMA-Na and MELD 3.0.

Methods: Nationwide cohort study including adult patients listed for a first elective LT (January 2016-December 2021). The primary outcome was mortality or delisting for sickness within the first 90 days. Independent predictors of the primary outcome were evaluated using multivariate Cox's regression with adjusted relative risks (RR) and 95% confidence intervals (95% CI). The discrimination of GEMA-Na and MELD 3.0was assessed using Harrell c-statistics (Hc).

Findings: The study included 6071 patients (4697 men and 1374 women). Mortality or delisting for clinical deterioration occurred in 286 patients at 90 days (4.7%). Women had reduced access to LT (83.7% vs. 85.9%; p = 0.037) and increased risk of mortality or delisting for sickness at 90 days (adjusted RR = 1.57 [95% CI 1.09-2.28]; p = 0.017). Female sex remained as an independent risk factor when using MELD or MELD-Na but lost its significance in the presence of GEMA-Na or MELD 3.0. Among patients included for reasons other than tumours (n = 3606; 59.4%), GEMA-Na had Hc = 0.753 (95% CI 0.715-0.792), which was higher than MELD 3.0 (Hc = 0.726 [95% CI 0.686-0.767; p = 0.001), showing both models adequate calibration.

Interpretation: GEMA-Na and MELD 3.0 might correct sex disparities for accessing LT, but GEMA-Na provides more accurate predictions of waiting list outcomes and could be considered the standard of care for waiting list prioritization.

Funding: Instituto de Salud Carlos III, Agencia Estatal de Investigación (Spain), and European Union.

Keywords: Allocation; Equity; Liver transplantation; Sex; Urgency.

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Conflict of interest statement

MLR-P has received lecture fees from Chiesi and Advanz Pharma, outside the present work. RM-M has received lecture fees from Chiesi, outside the present work. JC has received lecture fees from Chiesi and Astellas, outside the present work. All other authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Study flowchart showing outcomes on the waiting list, both at 90 days after registration (left side) and at maximal follow-up (right side).
Fig. 2
Fig. 2
Reclassification diagram between the Gender-Equity Model for liver Allocation corrected by serum sodium (GEMA-Na) and the Model for End Stage Liver Disease corrected by serum sodium (MELD-Na) in the whole study population (n = 6071). The diagonal line shows coinciding values of compared models. For a given MELD-Na score, deviations to the left indicate lower GEMA-Na and deviations to the right indicate higher GEMA-Na. Numbers in each box indicate percentages of change.
Fig. 3
Fig. 3
Reclassification diagram between the Gender-Equity Model for liver Allocation corrected by serum sodium (GEMA-Na) and the Model for End Stage Liver Disease 3.0 (MELD 3.0) in the whole study population (n = 6071). The diagonal line shows coinciding values of compared models. For a given MELD 3.0 score, deviations to the left indicate lower GEMA-Na and deviations to the right indicate higher GEMA-Na. Numbers in each box indicate percentages of change.
Fig. 4
Fig. 4
Cumulative incidence of mortality or delisting due to clinical deterioration with right-censoring at day 90 after listing. Patients were stratified according to the differential prioritization between GEMA-Na and MELD-Na (panel A), and between GEMA-Na and MELD 3.0 (panel B) as follows: both models agreed to transplant (dark grey curve), only GEMA-Na prioritized for transplantation (red curve), only the comparator prioritized for transplantation (blue curve), and none of the models assigned prioritization for transplantation (light grey). p values correspond to log rank test considering the four strata (overall p), or only considering differentially prioritized patients (differential p). GEMA-Na: Gender-Equity Model for liver Allocation corrected by serum sodium; MELD-Na: Model for End stage Liver Disease corrected by serum sodium; MELD 3.0: Model for End stage Liver Disease 3.0.
Supplementary Fig. S1
Supplementary Fig. S1
Supplementary Fig. S2
Supplementary Fig. S2
See this image and copyright information in PMC

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