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1. Hepatitis B-core Antibody Positive Donors in Liver Transplantation and Their Impact on Graft Survival: Evidence From The Liver Match Cohort Study

Author

Angelico M, Nardi A, Marianelli T, Caccamo L, Romagnoli R, Tisone G, Pinna AD, Avolio AW, Fagiuoli S, Burra P, Strazzabosco M, Nanni Costa A, U Cillo, P Caraceni, P L Toniutto, M Salizzoni, G Bertolotti, D Patrono, L De Carlis, A Slim, J M E Mangoni, G Rossi, 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, G L Grazi, A Cucchetti, C Zanfi, A Risaliti, M G Faraci, A Anselmo, I Lenci, D Sforza, S Agnes, M Di Mugno, G M Ettorre, L Miglioresi, G Vennarecci, Roma Sapienza, 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, C Gavrila, A Ricci, F Vespasiano, Angelico, M, Nardi, A, Marianelli, T, Caccamo, L, Romagnoli, R, Tisone, G, Pinna, A, Avolio, A, Fagiuoli, S, Burra, P, Strazzabosco, M, Costa, A, M, Angelico, A, Nardi, T, Marianelli, L, Caccamo, R, Romagnoli, G, Tisone, Ad, Pinna, Aw, Avolio, S, Fagiuoli, P, Burra, M, Strazzabosco, A, Nanni Costa, Cillo, U, Caraceni, P, L Toniutto, P, Salizzoni, M, Bertolotti, G, Patrono, D, De Carlis, L, Slim, A, E Mangoni, J M, Rossi, G, Antonelli, B, Mazzaferro, V, Regalia, E, Sposito, C, Colledan, M, Corno, V, Tagliabue, F, Marin, S, Vitale, A, Gringeri, E, Donataccio, M, Donataccio, D, Baccarani, U, Lorenzin, D, Bitetto, D, Valente, U, Gelli, M, Cupo, P, E Gerunda, G, Rompianesi, G, L Grazi, G, Cucchetti, A, Zanfi, C, Risaliti, A, G Faraci, M, Anselmo, A, Lenci, I, Sforza, D, Agnes, S, Di Mugno, M, M Ettorre, G, Miglioresi, L, Vennarecci, G, Sapienza, Roma, Berloco, P, Rossi, M, Ginanni-Corradini, S, Molinaro, A, Calise, F, Scuderi, V, Cuomo, O, Migliaccio, C, Lupo, L, Notarnicola, G, Gridelli, B, Volpes, R, Li Petri, S, Zamboni, F, Carbotta, G, Dedola, S, Gavrila, C, Ricci, A, Vespasiano, F, Mario Angelico, Alessandra Nardi, Tania Marianelli, Lucio Caccamo, Renato Romagnoli, Giuseppe Tisone, Antonio D. Pinna, Alfonso W. Avolio, Stefano Fagiuoli, Patrizia Burra, Mario Strazzabosco, Alessandro Nanni Costa, For the Liver Match Investigators [.., Paolo Caraceni, and ]

Subjects
Male, HBsAg, medicine.medical_treatment, Settore MED/18 - CHIRURGIA GENERALE, graft survival, De novo HBV infection, Donor Risk Index, Donor-recipient matching, HBcAb positive donors, Liver transplantation, medicine.disease_cause, Gastroenterology, Cohort Studies, Model for End-Stage Liver Disease, MED/12 - GASTROENTEROLOGIA, HBcAb positive donor, liver transplantation, Prospective Studies, Prospective cohort study, Settore MED/12 - Gastroenterologia, Hepatitis B Core Antigen, Hazard ratio, Middle Aged, Hepatitis B, Hepatitis B Core Antigens, Tissue Donors, Italy, Hepatocellular carcinoma, HCV, outcome, Female, Human, hbcab positive donors, Adult, medicine.medical_specialty, donor risk index, HBcAb positive, Tissue Donor, survival, donor-recipient matching, Donor Selection, Hepatitis B Antibodie, HBV, liver transplantation, Internal medicine, medicine, Humans, de novo hbv infection, Hepatitis B Antibodies, Donor-recipient matching, HBcAb positive donors, De novo HBV infection, Donor Risk Index, Aged, Hepatitis B virus, Hepatitis, Hepatology, business.industry, LIVER TRANSPLANTATION, medicine.disease, Surgery, Prospective Studie, Liver Transplantation, Graft Survival, Cohort Studie, business
Abstract

Background & Aims: The appropriate allocation of grafts from HBcAb positive donors in liver transplantation is crucial, yet a consensus is still lacking. Methods: We evaluated this issue within Liver Match, a prospective observational Italian study. Data from 1437 consecutive, first transplants performed in 2007-2009 using grafts from deceased heart beating donors were analyzed (median follow-up: 1040 days). Of these, 219 (15.2%) were HBcAb positive. Sixty-six HBcAb positive grafts were allocated to HBsAg positive and 153 to HBsAg negative recipients. Results: 329 graft losses occurred (22.9%): 66 (30.1%) among 219 recipients of HBcAb positive grafts, and 263 (21.6%) among 1218 recipients of HBcAb negative grafts. Graft survival was lower in recipients of HBcAb positive compared to HBcAb negative donors, with unadjusted 3-year graft survival of 0.69 (s.e. 0.032) and 0.77 (0.013), respectively (log-rank, p = 0.0047). After stratifying for recipient HBsAg status, this difference was only observed among HBsAg negative recipients (log rank, p = 0.0007), 3-year graft survival being excellent (0.88, s.e. 0.020) among HBsAg positive recipients, regardless of the HBcAb donor status (log rank, p = 0.4478). Graft loss due to de novo HBV hepatitis occurred only in one patient. At Cox regression, hazard ratios for graft loss were: MELD (1.30 per 10 units, p = 0.0002), donor HBcAb positivity (1.56, p = 0.0015), recipient HBsAg positivity (0.43, p

Published
2012

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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