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1. A Bayesian methodology to improve prediction of early graft loss after liver transplantation derived from the Liver Match study

Author

Mario Angelico, Alessandra Nardi, Renato Romagnoli, Tania Marianelli, Stefano Ginanni Corradini, Francesco Tandoi, Caius Gavrila, Mauro Salizzoni, Antonio D. Pinna, Umberto Cillo, Bruno Gridelli, Luciano G. De Carlis, Michele Colledan, Giorgio E. Gerunda, Alessandro Nanni Costa, Mario Strazzabosco, M. Angelico, U. Cillo, S. Fagiuoli, M. Strazzabosco, P. Caraceni, P.L. Toniutto, A. Nanni Costa, Torino M. Salizzoni, R. Romagnoli, G. Bertolotti, D. Patrono, L. De Carlis, A. Slim, J.M.E. Mangoni, G. Rossi, L. Caccamo, B. Antonelli, V. Mazzaferro, E. Regalia, C. Sposito, M. Colledan, V. Corno, F. Tagliabue, S. Marin, A. Vitale, E. Gringeri, M. Donataccio, D. Donataccio, U. Baccarani, D. Lorenzin, D. Bitetto, U. Valente, M. Gelli, P. Cupo, G.E. Gerunda, G. Rompianesi, A.D. Pinna, G.L. Grazi, A. Cucchetti, C. Zanfi, A. Risaliti, M.G. Faraci, G. Tisone, A. Anselmo, I. Lenci, D. Sforza, S. Agnes, M. Di Mugno, A.W. Avolio, G.M. Ettorre, L. Miglioresi, G. Vennarecci, P. Berloco, M. Rossi, S. Ginanni Corradini, A. Molinaro, F. Calise, V. Scuderi, O. Cuomo, C. Migliaccio, L. Lupo, G. Notarnicola, B. Gridelli, R. Volpes, S. Li Petri, F. Zamboni, G. Carbotta, S. Dedola, A. Nardi, T. Marianelli, C. Gavrila, A. Ricci, F. Vespasiano, Angelico, M., Nardi, A., Romagnoli, R., Marianelli, T., Corradini, S. G., Tandoi, F., Gavrila, C., Salizzoni, M., Pinna, A. D., Cillo, U., Gridelli, B., De Carlis, L. G., Colledan, M., Gerunda, G. E., Costa, A. N., Strazzabosco, M., Fagiuoli, S., Caraceni, P., Toniutto, P. L., Sal-izzoni, T. M., Bertolotti, G., Patrono, D., Decarlis, L., Slim, A., Mangoni, J. M. E., Rossi, G., Caccamo, L., Antonelli, B., Mazzaferro, V., Regalia, E., Sposito, C., Corno, V., Marin, S., Vitale, A., Gringeri, E., Donataccio, M., Donataccio, D., Baccarani, U., Lorenzin, D., Bitetto, D., Valente, U., Gelli, M., Cupo, P., Rompianesi, G., Grazi, G. L., Cucchetti, A., Zanfi, C., Risaliti, A., Faraci, M. G., Tisone, G., Anselmo, A., Lenci, I., Sforza, D., Agnes, S., Di Mugno, M., Avolio, A. M., Ettorre, G. M., Miglioresi, L., Vennarecci, G., Berloco, P., Rossi, M., Corradini, G., Molinaro, A., Calise, F., Scuderi, V., Cuomo, O., Migliaccio, C., Lupo, L., Notarnicola, G., Volpes, R., Lipetri, S., Zamboni, G., Carbotta, G., Dedola, S., Angelico, M, Nardi, A, Romagnoli, R, Marianelli, T, Corradini, S, Tandoi, F, Gavrila, C, Salizzoni, M, Pinna, A, Cillo, U, Gridelli, B, DE CARLIS, L, Colledan, M, Gerunda, G, Costa, A, Strazzabosco, M, and Fagiuoli, S

Subjects
Graft Rejection, Male, liver match, Multivariate analysis, medicine.medical_treatment, Settore MED/18 - CHIRURGIA GENERALE, Disease, Liver transplantation, Body Mass Index, Cohort Studies, MED/12 - GASTROENTEROLOGIA, Risk Factors, liver transplantation, early graft loss, Age Factor, Prospective Studies, Multivariate Analysi, hepatitis c, donor risk index, donor-recipient match, graft failure, transplantation outcome, risk factors, Donor Risk Index, Donor-recipient match, Graft failure, Hepatitis C, Risk factors, Transplantation outcome, Settore MED/12 - Gastroenterologia, Cold Ischemia, Graft Survival, Age Factors, Gastroenterology, Middle Aged, Tissue Donors, Treatment Outcome, Italy, Cohort, Female, Human, Adult, United Network for Organ Sharing, medicine.medical_specialty, Tissue Donor, Delayed Graft Function, Bayesan methodology, Risk Assessment, End Stage Liver Disease, medicine, Humans, Aged, Proportional Hazards Models, Hepatology, business.industry, Proportional hazards model, Risk Factor, Bayes Theorem, medicine.disease, Surgery, Prospective Studie, Multivariate Analysis, Proportional Hazards Model, Cohort Studie, Primary Graft Dysfunction, business, Body mass index, Transplantation Outcome
Abstract

Background: To generate a robust predictive model of Early (3 months) Graft Loss after liver transplantation, we used a Bayesian approach to combine evidence from a prospective European cohort (Liver-Match) and the United Network for Organ Sharing registry. Methods: Liver-Match included 1480 consecutive primary liver transplants performed from 2007 to 2009 and the United Network for Organ Sharing a time-matched series of 9740 transplants. There were 173 and 706 Early Graft Loss, respectively. Multivariate analysis identified as significant predictors of Early Graft Loss: donor age, donation after cardiac death, cold ischaemia time, donor body mass index and height, recipient creatinine, bilirubin, disease aetiology, prior upper abdominal surgery and portal thrombosis. Results: A Bayesian Cox model was fitted to Liver-Match data using the United Network for Organ Sharing findings as prior information, allowing to generate an Early Graft Loss-Donor Risk Index and an Early Graft Loss-Recipient Risk Index. A Donor-Recipient Allocation Model, obtained by adding Early Graft Loss-Donor Risk Index to Early Graft Loss-Recipient Risk Index, was then validated in a distinct United Network for Organ Sharing (year 2010) cohort including 2964 transplants. Donor-Recipient Allocation Model updating using the independent Turin Transplant Centre dataset, allowed to predict Early Graft Loss with good accuracy (c-statistic: 0.76). Conclusion: Donor-Recipient Allocation Model allows a reliable donor and recipient-based Early Graft Loss prediction. The Bayesian approach permits to adapt the original Donor-Recipient Allocation Model by incorporating evidence from other cohorts, resulting in significantly improved predictive capability. © 2013 Editrice Gastroenterologica Italiana S.r.l.

Published
2014

2. Liver Match, a prospective observational cohort study on liver transplantation in Italy: study design and current practice of donor-recipient matching

Author

Mario Angelico 1, Umberto Cillo, Stefano Fagiuoli, Antonio Gasbarrini, Caius Gavrila, Tania Marianelli, Alessandro Nanni Costa, Alessandra Nardi, Mario Strazzabosco, Patrizia Burra, Salvatore Agnes, Umberto Baccarani, Fulvio Calise, Michele Colledan, Oreste Cuomo, Luciano De Carlis, Matteo Donataccio, Giuseppe M Ettorre, Giorgio E Gerunda, Bruno Gridelli, Luigi Lupo, Vincenzo Mazzaferro, Antonio Pinna, Andrea Risaliti, Mauro Salizzoni, Giuseppe Tisone, Umberto Valente, Giorgio Rossi, Massimo Rossi, Fausto Zamboni, S Fagiuoli, A Gasbarrini, M Strazzabosco, D Prati, F Piscaglia, P G Toniutto, L Rizzato, S Venettoni, A Nardi, A Ricci, R Romagnoli, G Bertolotti, D Patrono, J M E Mangoni, L Caccamo, B Antonelli, E Regalia, C Sposito, V Corno, F Tagliabue, S Marin, E Gringeri, D Donataccio, F Bresadola, D Lorenzin, M Gelli, G Rompianesi, A Cucchetti, M G Faraci, D Sforza, S Agnes, M Di Mugno, L Miglioresi, M Rossi, S Ginanni Corradini, A Molinaro, V Scuderi, G Arenga, G Notarnicola, B Gridelli, S Li Petri, G Carbotta, S Dedola, C Gavrila, F Vespasiano, Angelico M, Cillo U, Fagiuoli S, Gasbarrini A, Costa AN, Strazzabosco M, Prati D, Piscaglia F, Toniutto PG, Burra P, Rizzato L, Venettoni S, Marianelli T, Salizzoni M, Romagnoli R, Bertolotti G, Patrono D, De Carolis L, Mangoni JM, Rossi G, Caccamo L, Antonelli B, Mazzaferro V, Regalia E, Sposito C, Colledan M, Corno V, Tagliabue F, Marin S, Gringeri E, Donataccio, Donataccio D, Bresadola F, Lorenzin D, Valente U, Gelli M, Gerunda GE, Rompianesi G, Pinna A, Grazi GL, Cucchetti A, Risaliti A, Faraci MG, Tisone G, Sforza D, Agnes S, Di Mugno M, Ettorre GM, Miglioresi L, Berloco P, Rossi M, Ginanni Corradini S, Molinaro A, Calise F, Scuderi V, Cuomo O, Arenga G, Lupo L, Notarnicola G, Gridelli B, Li Petri S, Zamboni F, Carbotta G, Dedola S, Nardi A, Gavrila C, Ricci A, Vespasiano F, Baccarani U, 1, Mario Angelico, Cillo, Umberto, Fagiuoli, Stefano, Gasbarrini, Antonio, Gavrila, Caiu, Marianelli, Tania, Nanni Costa, Alessandro, Nardi, Alessandra, Strazzabosco, Mario, Burra, Patrizia, Agnes, Salvatore, Baccarani, Umberto, Calise, Fulvio, Colledan, Michele, Cuomo, Oreste, De Carlis, Luciano, Donataccio, Matteo, M Ettorre, Giuseppe, E Gerunda, Giorgio, Gridelli, Bruno, Lupo, Luigi, Mazzaferro, Vincenzo, Pinna, Antonio, Risaliti, Andrea, Salizzoni, Mauro, Tisone, Giuseppe, Valente, Umberto, Rossi, Giorgio, Rossi, Massimo, Zamboni, Fausto, Fagiuoli, S, Gasbarrini, A, Strazzabosco, M, Prati, D, Piscaglia, F, G Toniutto, P, Rizzato, L, Venettoni, S, Nardi, A, Ricci, A, Romagnoli, R, Bertolotti, G, Patrono, D, E Mangoni, J M, Caccamo, L, Antonelli, B, Regalia, E, Sposito, C, Corno, V, Tagliabue, F, Marin, S, Gringeri, E, Donataccio, D, Bresadola, F, Lorenzin, D, Gelli, M, Rompianesi, G, Cucchetti, A, G Faraci, M, Sforza, D, Agnes, S, Di Mugno, M, Miglioresi, L, Rossi, M, Ginanni Corradini, S, Molinaro, A, Scuderi, V, Arenga, G, Notarnicola, G, Gridelli, B, Li Petri, S, Carbotta, G, Dedola, S, Gavrila, C, Vespasiano, F, Angelico, M, Cillo, U, Marianelli, T, Costa, A, Burra, P, Baccarani, U, Calise, F, Colledan, M, Cuomo, O, DE CARLIS, L, Donataccio, M, Ettorre, G, Gerunda, G, Lupo, L, Mazzaferro, V, Pinna, A, Risaliti, A, Salizzoni, M, Tisone, G, Valente, U, Rossi, G, Zamboni, F, and Liver Match, I

Subjects
impact of donor/recipient matching on outcomes, Male, Alcoholic liver disease, Cirrhosis, Multicenter Study, Humans, Prospective Study, Liver Transplantation, Donor Risk Index, Hepatocellular Carcinoma, Italy, Donor Liver transplant Recipient, donor match, liver transplantation, donor, recipient, Settore MED/18 - CHIRURGIA GENERALE, medicine.medical_treatment, liver-match, liver transplant, Liver transplantation, Model for End-Stage Liver Disease, MED/12 - GASTROENTEROLOGIA, Prospective Studies, Prospective cohort study, Child, Liver transplant, donor, Aged, 80 and over, Settore MED/12 - Gastroenterologia, education.field_of_study, liver transplantation, Histocompatibility Testing, Graft Survival, Liver Neoplasms, Gastroenterology, Middle Aged, liver transplantations, liver transplant, information on donors and recipients, recipient, Tissue Donors, Treatment Outcome, Donor, Recipient, Hepatocellular carcinoma, Female, Cohort study, Adult, medicine.medical_specialty, Tissue and Organ Procurement, Adolescent, Waiting Lists, Population, NO, Internal medicine, medicine, education, donor match, Aged, Hepatology, business.industry, Patient Selection, Settore MED/09 - MEDICINA INTERNA, medicine.disease, Fibrosis, Surgery, business
Abstract

BACKGROUND: The Liver Match is an observational cohort study that prospectively enrolled liver transplantations performed at 20 out of 21 Italian Transplant Centres between June 2007 and May 2009. Aim of the study is to investigate the impact of donor/recipient matching on outcomes. In this report we describe the study methodology and provide a cross-sectional description of donor and recipient characteristics and of graft allocation. METHODS: Adult primary transplants performed with deceased heart-beating donors were included. Relevant information on donors and recipients, organ procurement and allocation were prospectively entered in an ad hoc database within the National Transplant Centre web-based Network. Data were blindly analysed by an independent Biostatistical Board. RESULTS: The study enrolled 1530 donor/recipient matches. Median donor age was 56 years. Female donors (n = 681, median 58, range 12-92 years) were older than males (n = 849, median 53, range 2-97 years, p < 0.0001). Donors older than 60 years were 42.2%, including 4.2% octogenarians. Brain death was due to non-traumatic causes in 1126 (73.6%) cases. Half of the donor population was overweight, 10.1% was obese and 7.6% diabetic. Hepatitis B core antibody (HBcAb) was present in 245 (16.0%) donors. The median Donor Risk Index (DRI) was 1.57 (>1.7 in 35.8%). The median cold ischaemia time was 7.3h (≥ 10 in 10.6%). Median age of recipients was 54 years, and 77.7% were males. Hepatocellular carcinoma (HCC) was the most frequent indication overall (44.4%), being a coindication in roughly 1/3 of cases, followed by viral cirrhosis without HCC (28.2%) and alcoholic cirrhosis without HCC (10.2%). Hepatitis C virus infection (with or without HCC) was the most frequent etiologic factor (45.9% of the whole population and 71.4% of viral-related cirrhosis), yet hepatitis B virus infection accounted for 28.6% of viral-related cirrhosis, and HBcAb positivity was found in 49.7% of recipients. The median Model for End Stage Liver Disease (MELD) at transplant was 12 in patients with HCC and 18 in those without. Multivariate analysis showed a slight but significant inverse association between DRI and MELD at transplant. CONCLUSIONS: The deceased donor population in Italy has a high-risk profile compared to other countries, mainly due to older donor age. Almost half of the grafts are transplanted in recipients with HCC. Higher risk donors tend to be preferentially allocated to recipients with HCC, who are usually less ill and older. No other relevant allocation strategy is currently adopted at national level.

Published
2010

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