60 results on '"Belli, LS"'
Search Results
2. Difference in health related quality of life of chronic liver diseases and general population: Paolo Angelo Cortesi
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Cortesi, PA, Conti, S, Scalone, L, Ciaccio, A, Okolicsanyi, S, Rota, M, Belli, LS, Cesana, G, Strazzabosco, M, and Mantovani, LG
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- 2017
- Full Text
- View/download PDF
3. Protective role of tacrolimus, deleterious role of age and comorbidities in liver transplant recipients with Covid-19: results from the ELITA/ELTR multi-center European study
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Belli LS, Fondevila C, Cortesi PA, Conti S, Karam V, Adam R, Coilly A, Ericzon BG, Loinaz C, Cuervas-Mons V, Zambelli M, Llado L, Diaz F, Invernizzi F, Patrono D, Faitot F, Bhooori S, Pirenne J, Perricone G, Magini G, Castells L, Detry O, Cruchaga PM, Colmenero J, Berrevoet F, Rodriguez G, Ysebaert D, Radenne S, Metselaar H, Morelli C, De Carlis L, Polak WG, Duvoux C, and ELITA-ELTR COVID-19 Registry
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Liver transplantation ,COVID-19 ,Tacrolimus ,Outcome - Abstract
BACKGROUND AND AIMS: Despite concerns that liver transplant (LT) recipients may be at increased risk of unfavorable outcomes from COVID-19 due the high prevalence of co-morbidities, immunosuppression and ageing, a detailed analysis of their effects in large studies is lacking. METHODS: Data from adult LT recipients with laboratory confirmed SARS-CoV2 infection were collected across Europe. All consecutive patients with symptoms were included in the analysis. RESULTS: Between March 1st and June 27th2020, data from 243 adult symptomatic cases from 36 centers and 9 countries were collected. Thirty-nine (16%) were managed as outpatients while 204 (84%) required hospitalization including admission to the ICU (39/204, 19.1%). Forty-nine (20.2%) patients died after a median of 13.5 (10-23) days, respiratory failure was the major cause. After multivariable Cox regression analysis, age >70 (HR, 4.16; 95% CI, 1.78-9.73) had a negative effect and tacrolimus (TAC) use (HR, 0.55; 95% CI, 0.31-0.99) had a positive independent effect on survival. The role of co-morbidities was strongly influenced by the dominant effect of age where comorbidities increased with the increasing age of the recipients. In a second model excluding age, both diabetes (HR, 1.95; 95% CI, 1.06-3.58) and chronic kidney disease (HR, 1.97; 95% CI, 1.05-3.67) emerged as associated with death CONCLUSIONS: Twenty-five per cent of patients requiring hospitalization for Covid-19 died, the risk being higher in patients older than 70 and with medical co-morbidities, such as impaired renal function and diabetes. Conversely, the use of TAC was associated with a better survival thus encouraging clinicians to keep TAC at the usual dose.
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- 2021
4. Temporal Trends and Outcomes in Liver Transplantation for Recipients with Human Immunodeficiency Virus Infection in Europe and United States
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Campos-Varela I, Dodge JL, Berenguer M, Adam R, Samuel D, Di Benedetto F, Karam V, Belli LS, Duvoux C, and Terrault NA
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We evaluated trends and outcomes of liver transplantation (LT) recipients with/without human immunodeficiency virus (HIV) infection.
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- 2019
5. THE CASE-MIX IN LIVER TRANSPLANTATION. DIFFERENT PERCEPTIONS (TRANSPLANT SURGEONS AND TRANSPLANT HEPATOLOGISTS) AND DIFFERENT CONCORDANCE LEVELS WITHIN CENTERS
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Calia, R, Avolio, A, Luciani, M, Franco, A, Lai, Q, Vivarelli, M, Benedetti, A, Lupo, L, Rendina, M, Colledan, M, Fagiuoli, S, Cescon, M, Morelli, C, Zamboni, F, Mameli, L, De Carlis, L, Belli, L, Rossi, G, Donato, F, Mazzaferro, V, Bhoori, S, Di Benedetto, F, De Maria, N, Santaniello, W, Di Costanzo, G, Gruttadauria, S, Volpes, R, De Simone, P, Carrai, P, Spada, M, Nobile, V, Agnes, S, Grieco, A, Spoletini, G, Ettorre, G, Giannelli, V, Tisone, G, Lenci, I, Rossi, M, Corradini, S, Romagnoli, R, Martini, S, Risaliti, A, Toniutto, P, Tedeschi, U, Carraro, A, Burra, P, Cillo, U, Calia R, Avolio A, Luciani M, Franco A, Lai Q, Vivarelli M, Benedetti A, Lupo L, Rendina M, Colledan M, Fagiuoli S, Cescon M, Morelli C, Zamboni F, Mameli L, De Carlis L, Belli LS, Rossi G, Donato F, Mazzaferro V, Bhoori S, Di Benedetto F, De Maria N, Santaniello W, Di Costanzo G, Gruttadauria S, Volpes R, De Simone P, Carrai P, Spada M, Nobile V, Agnes S, Grieco A, Spoletini G, Ettorre G, Giannelli V, Tisone G, Lenci I, Rossi M, Corradini SG, Romagnoli R, Martini S, Risaliti A, Toniutto P, Tedeschi U, Carraro A, Burra P, Cillo U, Calia, R, Avolio, A, Luciani, M, Franco, A, Lai, Q, Vivarelli, M, Benedetti, A, Lupo, L, Rendina, M, Colledan, M, Fagiuoli, S, Cescon, M, Morelli, C, Zamboni, F, Mameli, L, De Carlis, L, Belli, L, Rossi, G, Donato, F, Mazzaferro, V, Bhoori, S, Di Benedetto, F, De Maria, N, Santaniello, W, Di Costanzo, G, Gruttadauria, S, Volpes, R, De Simone, P, Carrai, P, Spada, M, Nobile, V, Agnes, S, Grieco, A, Spoletini, G, Ettorre, G, Giannelli, V, Tisone, G, Lenci, I, Rossi, M, Corradini, S, Romagnoli, R, Martini, S, Risaliti, A, Toniutto, P, Tedeschi, U, Carraro, A, Burra, P, Cillo, U, Calia R, Avolio A, Luciani M, Franco A, Lai Q, Vivarelli M, Benedetti A, Lupo L, Rendina M, Colledan M, Fagiuoli S, Cescon M, Morelli C, Zamboni F, Mameli L, De Carlis L, Belli LS, Rossi G, Donato F, Mazzaferro V, Bhoori S, Di Benedetto F, De Maria N, Santaniello W, Di Costanzo G, Gruttadauria S, Volpes R, De Simone P, Carrai P, Spada M, Nobile V, Agnes S, Grieco A, Spoletini G, Ettorre G, Giannelli V, Tisone G, Lenci I, Rossi M, Corradini SG, Romagnoli R, Martini S, Risaliti A, Toniutto P, Tedeschi U, Carraro A, Burra P, and Cillo U
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- 2019
6. Delisting HCV-infected liver transplant candidates who improved after viral eradication: Outcome 2 years after delisting
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Perricone, G, Duvoux, C, Berenguer, M, Cortesi, PA, Vinaixa, C, Facchetti, R, Mazzarelli, C, Rockenschaub, SR, Martini, S, Morelli, C, Monico, S, Volpes, R, Pageaux, GP, Fagiuoli, S, Belli, LS, and European Liver Intestine Transpla
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liver transplantation ,delisting ,cirrhosis ,direct-acting antivirals - Abstract
Backgrounds & Aims Treating patients with decompensated cirrhosis with direct-acting antiviral (DAA) therapy while on the waiting list for liver transplantation results in substantial improvement of liver function allowing 1 in 4 patients to be removed from the waiting list or delisted, as reported in a previous study promoted by the European Liver and Intestine Transplant Association (ELITA). The aim of this study was to report on clinical outcomes of delisted patients, including mortality risk, hepatocellular carcinoma development and clinical decompensation requiring relisting. Methods Results One hundred and forty-two HCV-positive patients on the liver transplant waiting list for decompensated cirrhosis, negative for hepatocellular carcinoma, between February 2014 and June 2015 were treated with DAA therapy and were prospectively followed up. Forty-four patients (30.9%) were delisted following clinical improvement. This percentage was higher than in the original study because of a number of patients being delisted long after starting DAAs. The median Child-Pugh and MELD score of delisted patients was 5.5 and 9 respectively. Four patients were relisted, because of HCC diagnosis in 1 case and 3 patients developed ascites. One further patient died (2.4%) because of rapidly progressing hepatocellular carcinoma twenty-two months after delisting. Of the 70 patients who received a liver graft, 9 died (13%). Conclusions Antiviral therapy allows for a long-term improvement of liver function and the delisting of one-third of treated patients with risk of liver-related complications after delisting being very low.
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- 2018
7. Impact of DAAs on liver transplantation: Major effects on the evolution of indications and results. An ELITA study based on the ELTR registry
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Belli, LS, Perricone, G, Adam, R, Cortesi, PA, Strazzabosco, M, Facchetti, R, Karam, V, Salizzoni, M, Andujar, RL, Fondevila, C, De Simone, P, Morelli, C, Fabregat-Prous, J, Samuel, D, Agarwaal, K, Gonzales, EM, Charco, R, Zieniewicz, K, De Carlis, L, Duvoux, C, and ELITA
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EtOH ,Waiting list ,HCV ,HBV ,NASH ,digestive system diseases ,Liver Transplantation - Abstract
Background & Aims: Direct-acting antivirals (DAAs) have dramatically improved the outcome of patients with hepatitis C virus (HCV) infection including those with decompensated cirrhosis (DC). We analyzed the evolution of indications and results of liver transplantation (LT) in the past 10 years in Europe, focusing on the changes induced by the advent of DAAs. Methods: This is a cohort study based on data from the European Liver Transplant Registry (ELTR). Data of adult LTs performed between January 2007 to June 2017 for HCV, hepatitis B virus (HBV), alcohol (EtOH) and non-alcoholic steatohepatitis (NASH) were analyzed. The period was divided into different eras: interferon (IFN/RBV; 2007-2010), protease inhibitor (PI; 2011-2013) and second generation DAA (DAA; 2014-June 2017). Results: Out of a total number of 60,527 LTs, 36,382 were performed in patients with HCV, HBV, EtOH and NASH. The percentage of LTs due to HCV-related liver disease varied significantly over time (p
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- 2018
8. Impact of new HCV therapies on liver transplantation: the European Liver Transplant Registry study
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Cortesi, PA, primary, Belli, LS, additional, Perricone, G, additional, Adam, R, additional, Strazzabosco, M, additional, Facchetti, R, additional, Karam, V, additional, and Duvoux, C, additional
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- 2018
- Full Text
- View/download PDF
9. Applicazione della value-based medicine nella valutazione della cura dei pazienti affetti da epatite.
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Fornari, C, Cortesi, P, Conti, S, Okolicsanyi, S, Rota, M, Ciaccio, A, Gemma, M, Scalone, L, Cesana, G, Cozzolino, P, Fabris, L, Colledan, M, Fagiuoli, S, Ideo, G, Garcia-Tsao, G, Belli, L, Munari, L, Mantovani, L, Strazzabosco, M, Cortesi, PA, Belli, LS, Munari, LM, Mantovani, LG, Fornari, C, Cortesi, P, Conti, S, Okolicsanyi, S, Rota, M, Ciaccio, A, Gemma, M, Scalone, L, Cesana, G, Cozzolino, P, Fabris, L, Colledan, M, Fagiuoli, S, Ideo, G, Garcia-Tsao, G, Belli, L, Munari, L, Mantovani, L, Strazzabosco, M, Cortesi, PA, Belli, LS, Munari, LM, and Mantovani, LG
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- 2018
10. Optimising the clinical strategy for autoimmune liver diseases: Principles of value-based medicine
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Carbone, M, Cristoferi, L, Cortesi, P, Rota, M, Ciaccio, A, Okolicsanyi, S, Gemma, M, Scalone, L, Cesana, G, Fabris, L, Colledan, M, Fagiuoli, S, Ideo, G, Belli, L, Munari, L, Mantovani, L, Strazzabosco, M, Cortesi, PA, Belli, LS, Munari, LM, Carbone, M, Cristoferi, L, Cortesi, P, Rota, M, Ciaccio, A, Okolicsanyi, S, Gemma, M, Scalone, L, Cesana, G, Fabris, L, Colledan, M, Fagiuoli, S, Ideo, G, Belli, L, Munari, L, Mantovani, L, Strazzabosco, M, Cortesi, PA, Belli, LS, and Munari, LM
- Abstract
Background: Autoimmune hepatitis, primary biliary cholangitis, and primary sclerosing cholangitis represent the three major autoimmune liver diseases (AILDs). Their management is highly specialized, requires a multidisciplinary approach and often relies on expensive, orphan drugs. Unfortunately, their treatment is often unsatisfactory, and the care pathway heterogeneous across different centers. Disease-specific clinical outcome indicators (COIs) able to evaluate the whole cycle of care are needed to assist both clinicians and administrators in improving quality and value of care. Aim of our study was to generate a set of COIs for the three AILDs. We then prospectively validated these indicators based on a series of consecutive patients recruited at three tertiary clinical centers in Lombardy, Italy. Methods: In phase I using a Delphi method and a RAND 9-point appropriateness scale a set of COIs was generated. In phase II the indicators were applied in a real-life dataset. Results: Two-hundred fourteen patients were enrolled and followed-up for a median time of 54. months and the above COIs were recorded using a web-based electronic medical record program. The COIs were easy to collect in the clinical practice environment and their values compared well with the available natural history studies. Conclusions: We have generated a comprehensive set of COIs which sequentially capture different clinical outcome of the three AILDs explored. These indicators represent a critical tool to implement a value-based approach to patients with these conditions, to monitor, compare and improve quality through benchmarking of clinical performance and to assess the significance of novel drugs and technologies. This article is part of a Special Issue entitled: Cholangiocytes in Health and Diseaseedited by Jesus Banales, Marco Marzioni, Nicholas LaRusso and Peter Jansen.
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- 2018
11. Impatto dei farmaci anti virali ad azione diretta sulla cura dei pazienti con epatite C: un approccio di value-based medicine
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Conti, S, Cortesi, P, Okolicsanyi, S, Rota, M, Ciaccio, A, Gemma, M, Scalone, L, Cesana, G, Cozzolino, P, Fabris, L, Colledan, M, Fagiuoli, S, Ideo, G, Garcia-Tsao, G, Belli, L, Munari, L, Mantovani, L, Strazzabosco, M, Conti S, Cortesi PA, Okolicsanyi S, Rota M, Ciaccio A, Gemma M, Scalone L, Cesana G, Cozzolino P, Fabris L, Colledan M, Fagiuoli S, Ideo G, Garcia-Tsao G, Belli LS, Munari LM, Mantovani LG, Strazzabosco M, Conti, S, Cortesi, P, Okolicsanyi, S, Rota, M, Ciaccio, A, Gemma, M, Scalone, L, Cesana, G, Cozzolino, P, Fabris, L, Colledan, M, Fagiuoli, S, Ideo, G, Garcia-Tsao, G, Belli, L, Munari, L, Mantovani, L, Strazzabosco, M, Conti S, Cortesi PA, Okolicsanyi S, Rota M, Ciaccio A, Gemma M, Scalone L, Cesana G, Cozzolino P, Fabris L, Colledan M, Fagiuoli S, Ideo G, Garcia-Tsao G, Belli LS, Munari LM, Mantovani LG, and Strazzabosco M
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- 2018
12. ELITA consensus statements on the use of DAAs in liver transplant candidates and recipients
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Belli, LS, Duvoux, C, Berenguer, M, Berg, T, Coilly, A, Colle, I, Fagiuoli, S, Khoo, S, Pageaux, GP, Puoti, M, Samuel, D, and Strazzabosco, M
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Hepatitis C, chronic ,Antiviral agents ,Liver transplantation ,Waiting lists ,Liver failure ,Liver transplant recipient ,Recurrent hepatitis C ,Interferons ,Guidelines ,Liver transplant candidate - Abstract
The advent of safe and highly effective direct-acting antiviral agents (DAAs) has had huge implications for the hepatitis C virus (HCV) transplant field, and changed our management of both patients on the waiting list and those with HCV graft re-infection after liver transplantation (LT). When treating HCV infection before LT, HCV re-infection of the graft can be prevented in nearly all patients. In addition, some candidates show a remarkable clinical improvement and may be delisted. Alternatively, HCV infection can be treated post-LT either soon after the transplant, taking advantage of the removal of the infected native liver, or at the time of disease recurrence, as was carried out in the past. In either case, some DAAs have a limited use because of their drug to drug interactions with various immunosuppressants as well as the many other drugs liver transplant recipients are often prescribed. In addition, some DAAs should be avoided in case of severe renal failure, which is not an unusual complication after LT. The present document provides a series of consensus statements on the LT issues that have not been extensively addressed previously. These statements have been developed to support physicians and other stakeholders in charge of LT candidates and recipients when deciding to treat HCV, especially in difficult situations. (C) 2017 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
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- 2017
13. Difference in health related quality of life of chronic liver diseases and general population
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Cortesi, P, Conti, S, Scalone, L, Ciaccio, A, Okolicsanyi, S, Rota, M, Belli, L, Cesana, G, Strazzabosco, M, Mantovani, L, Cortesi, PA, Belli, LS, Mantovani, LG, Cortesi, P, Conti, S, Scalone, L, Ciaccio, A, Okolicsanyi, S, Rota, M, Belli, L, Cesana, G, Strazzabosco, M, Mantovani, L, Cortesi, PA, Belli, LS, and Mantovani, LG
- Abstract
Objectives: The impact of chronic liver diseases (CLDs) on health-related quality of life (HRQoL) is relevant to understand the burden of these conditions and to inform decision-making processes. Exhaustive studies addressing simultaneously all major CLDs are still lacking, therefore we compared HRQoL of patients affected by major CLDs with that of the general population. Methods: We analyzed HRQoL data of Italian patients with major CLDs with those of a representative sample of the general Italian population. HRQoL data were collected using the EQ-5D-3L. In order to assess the association between each CLD and HRQoL, we performed multiple regression analyses, adjusting for possible confounders, using each domain of the EQ-5D descriptive system, the utility index and the visual analogue scale (VAS) as dependent variables. Results: Overall, data from 2,962 subjects with CLDs and from 6,800 individuals from the general population were analyzed. Advanced CLDs (decompensated cirrhosis and HCC) were associated with a significantly higher risk of reporting problems in physical domains(mobility, self-care and usual activity), autoimmune hepatitis in self-care, and hepatitis-C and NAFLD/NASH in anxiety/depression. Similar results were obtained with VAS and utility index: advanced CLDs were associated with a significant reduction in both indexes, while autoimmune hepatitis reduced only VAS score. Conclusions: HRQoL in early stage of CLDs is similar to the general population and it decreases with the progression to advanced stages. This study presents a real estimate of the impact of major CLDs on patients’ HRQoL, providing a key tool for decision-making in care delivery for CLDs. Key messages: Quality of life in early stage of chronic livers diseases is similar to the general population and lower in advanced stages. Our results providing a key tool for decision-making in care delivery
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- 2017
14. Practice guidelines for the treatment of hepatitis C: recommendations from an AISF/SIMIT/SIMAST Expert Opinion Meeting
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Prati, D, Gasbarrini, A, Mazzotta, F, Sagnelli, E, Carosi, G, Abrescia, N, Alberti, Alfredo, Ambu, S, Andreone, P, Andriulli, A, Angelico, M, Antonucci, G, Ascione, A, Belli, Ls, Bruno, R, Bruno, S, Burra, Patrizia, Camma, C, Caporaso, N, Cariti, G, Cillo, U, Coppola, N, Craxi, A, DE LUCA, A, DE MARTIN, E, DI MARCO, V, Fagiuoli, S, Ferrari, C, Gaeta, Gb, Galli, M, Grieco, A, Grossi, P, Licata, A, Maida, I, Mangia, A, Marino, N, Maserati, R, Missale, G, Mondelli, M, Nasta, P, Niro, G, Persico, M, Petrelli, E, Picciotto, A, Piscaglia, F, Pollicino, T, Puoti, C, Puoti, M, Raimondo, G, Rumi, Mg, Santantonio, T, Smedile, A, Squadrito, G, Baroni, Gs, Taliani, G, Tavio, M, Toti, M, Bonino, F, Brunetto, Mr, Cacopardo, B, Caremani, M, Cauda, R, Colombo, M, DI PERRI, G, Donato, F, Farci, P, Fattovich, G, Filice, G, Ghinelli, F, Guadagnino, V, Lazzarin, A, Levrero, M, Licata, G, Orani, A, Paffetti, A, Pastore, G, Piccinino, F, Pizzigallo, E, Pontisso, Patrizia, Portelli, V, Rizzetto, M, Rossi, A, Stroffolini, T, Ubaldi, E, Santantanio, T, Alberti, A., Antonucci, Gf, Craxi, A., Prati D, Gasbarrini A, Mazzotta F, Sagnelli E, Carosi G, Abrescia N, Alberti A, Ambu S, Andreone P, Andriulli A, Angelico M, Antonucci GF, Ascione A, Belli LS, Bruno R, Bruno S, Burra P, Cammà, C, Caporaso N, Cariti G, Cillo U, Coppola N, Craxì, A, De Luca A, De Martin E, Di Marco, V, Fagiuoli S, Ferrari C, Gaeta GB, Galli M, Grieco A, Grossi P, Licata, A, Maida I, Mangia A, Marino N, Maserati R, Missale G, Mondelli M, Nasta P, Niro G, Persico M, Petrelli E, Picciotto A, Piscaglia F, Pollicino T, Prati D, Puoti C, Puoti M, Raimondo G, Rumi MG, Sagnelli E, Santantonio T, Smedile A, Squadrito G, Baroni GS, Taliani G, Tavio M, Toti M, Bonino F, Brunetto MR, Cacopardo B, Caremani M, Cauda R, Colombo M, Di Perri G, Donato F, Farci P, Fattovich G, Filice G, Ghinelli F, Guadagnino V, Lazzarin A, Levrero M, Licata G, Orani A, Paffetti A, Pastore G, Piccinino F, Pizzigallo E, Pontisso P, Portelli V, Rizzetto M, Rossi A, Stroffolini T, Ubaldi E., Italian Association for the Study of the Liver, Italian Society of Infectious, Tropical Disease, Italian Society for the Study of Sexually Transmitted Diseases: Prati D., Gasbarrini A., Mazzotta F., Sagnelli E., Carosi G., Abrescia N., Alberti A., Ambu S., Andreone P., Andriulli A., Angelico M., Antonucci G.F., Ascione A., Belli L.S., Bruno R., Bruno S., Burra P., Cammà C., Caporaso N., Cariti G., Cillo U., Coppola N., Craxì A., De Luca A., De Martin E., Di Marco V., Fagiuoli S., Ferrari C., Gaeta G.B., Galli M., Grieco A., Grossi P., Licata A., Maida I., Mangia A., Marino N., Maserati R., Missale G., Mondelli M., Nasta P., Niro G., Persico M., Petrelli E., Picciotto A., Piscaglia F., Pollicino T., Puoti C., Puoti M., Raimondo G., Rumi M.G., Santantonio T., Smedile A., Squadrito G., Baroni G.S., Taliani G., Tavio M., Toti M., Bonino F., Brunetto M.R., Cacopardo B., Caremani M., Cauda R., Colombo M., Di Perri G., Donato F., Farci P., Fattovich G., Filice G., Ghinelli F., Guadagnino V., Lazzarin A., Levrero M., Licata G., Orani A., Paffetti A., Pastore G., Piccinino F., Pizzigallo E., Pontisso P., Portelli V., Rizzetto M., Rossi A., Stroffolini T., Ubaldi E., Prati, D, Gasbarrini, A, Mazzotta, F, Sagnelli, E, Carosi, G, Abrescia, N, Alberti, A, Ambu, S, Andreone, P, Andriulli, A, Angelico, M, Antonucci, G, Ascione, A, Belli, L, Bruno, R, Bruno, S, Burra, P, Caporaso, N, Cariti, G, Cillo, U, Coppola, N, De Luca, A, De Martin, E, Fagiuoli, S, Ferrari, C, Gaeta, G, Galli, M, Grieco, A, Grossi, P, Maida, I, Mangia, A, Marino, N, Maserati, R, Missale, G, Mondelli, M, Nasta, P, Niro, G, Persico, M, Petrelli, E, Picciotto, A, Piscaglia, F, Pollicino, T, Puoti, C, Puoti, M, Raimondo, G, Rumi, M, Santantonio, T, Smedile, A, Squadrito, G, Baroni, G, Taliani, G, Tavio, M, Toti, M, Bonino, F, Brunetto, M, Cacopardo, B, Caremani, M, Cauda, R, Colombo, M, Di Perri, G, Donato, F, Farci, P, Fattovich, G, Filice, G, Ghinelli, F, Guadagnino, V, Lazzarin, A, Levrero, M, Licata, G, Orani, A, Paffetti, A, Pastore, G, Piccinino, F, Pizzigallo, E, Pontisso, P, Portelli, V, Rizzetto, M, Rossi, A, Stroffolini, T, and Ubaldi, E
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Liver Cirrhosis ,ANTIVIRAL TREATMENT ,Human immunodeficiency virus (HIV) ,HIV Infections ,Hepacivirus ,ANTIVIRAL THERAPY ,PEGYLATED INTERFERON-ALPHA-2B ,LIVER-TRANSPLANTATION ,PEGINTERFERON ALPHA-2A ,HIV-INFECTED PATIENTS ,VIRUS-COINFECTED PATIENTS ,RAPID VIROLOGICAL RESPONSE ,Antiviral therapy ,medicine.disease_cause ,Gastroenterology ,Polyethylene Glycols ,HBV ,guidelines ,Acute hepatitis ,Chronic hepatitis ,Settore MED/12 - Gastroenterologia ,liver transplantation ,Hepatitis C ,Recombinant Proteins ,acute hepatitis ,antiviral therapy ,chronic hepatitis ,cirrhosis ,elderly patients ,hbv ,hcv ,hdv ,hiv ,CLINICAL PRACTICE GUIDELINES ,Cirrhosis ,HCV ,Drug Therapy, Combination ,Antiviral therapy Acute hepatitis Chronic hepatitis,Cirrhosis, Elderly patients, HBV, HCV, HDV, HIV Liver transplantation ,Elderly patient ,Acute hepatiti ,medicine.medical_specialty ,Genotype ,Alpha interferon ,Interferon alpha-2 ,CHRONIC HEPATITIS C ,Antiviral Agents ,Hepatitis B, Chronic ,Internal medicine ,HDV ,Drug Resistance, Viral ,Ribavirin ,medicine ,Humans ,Cirrhosi ,Hepatology ,business.industry ,Settore MED/09 - MEDICINA INTERNA ,Interferon-alpha ,HIV ,Hepatitis C, Chronic ,medicine.disease ,Elderly patients ,Family medicine ,Expert opinion ,Chronic hepatiti ,business - Abstract
It is increasingly clear that a tailored therapeutic approach to patients with hepatitis C virus infection is needed. Success rates in difficult to treat and low-responsive hepatitis C virus patients are not completely satisfactory, and there is the need to optimise treatment duration and intensity in patients with the highest likelihood of response. In addition, the management of special patient categories originally excluded from phase III registration trials needs to be critically re-evaluated. This article reports the recommendations for the treatment of hepatitis C virus infection on an individual basis, drafted by experts of three scientific societies.
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- 2010
15. Sofosbuvir and ribavirinin in HCV-infected patients listed for liver transplantation: A cost-effectiveness analysis
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Cortesi, P, Mantovani, L, Ciaccio, A, Rota, M, Cesana, G, Strazzabosco, M, Belli, L, CORTESI, PAOLO ANGELO, CIACCIO, ANTONIO, ROTA, MATTEO, CESANA, GIANCARLO, STRAZZABOSCO, MARIO, MANTOVANI, LORENZO GIOVANNI, Belli, LS, Cortesi, P, Mantovani, L, Ciaccio, A, Rota, M, Cesana, G, Strazzabosco, M, Belli, L, CORTESI, PAOLO ANGELO, CIACCIO, ANTONIO, ROTA, MATTEO, CESANA, GIANCARLO, STRAZZABOSCO, MARIO, MANTOVANI, LORENZO GIOVANNI, and Belli, LS
- Abstract
Post-liver transplant recurrent hepatitis C virus (HCV) infection severely limits the prognosis of HCV-infected patients. Sofosbuvir in combination with ribavirin (SOF/RBV) is a novel interferon-free treatment able to suppress HCV viremia when applied to HCV patients listed for transplant, thereby preventing HCV recurrence. Aim of this study was to assess the cost-effectiveness of this regimens in patients listed for transplant for cirrhosis (HCV-cirrhosis) or for hepatocellular carcinoma in cirrhosis (HCV-HCC). A semi-Markov model was developed to assess the cost-effectiveness of pre-transplant SOF/RBV treatment in patients listed for HCV-cirrhosis and HCV-related HCC. The model simulates the progression of HCV-cirrhosis or HCV-HCC patients from the time of listing until death considering the risk of HCV recurrence post-transplant. The model compared 2 different strategies: 1) SOF/RBV up to a maximum of 24 weeks or until OLT if performed before the 24th week from the initiation of treatment, 2) No antiviral treatment. The model estimated the costs related to the treatment with SOF/RBV, the costs associated to each health state, the life-years (LYSs), the quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER) expressed as € per QALY gained. The analysis was performed from the Italian National Health System perspective with a lifetime time horizon and one-month Markov cycles. Future costs and clinical benefits, expressed as QALYs, were discounted at 3% per year. Results: in the base-case analysis the ICER for 24 weeks of SOF/RBVR was €30,518 per QALY gained in HCV-cirrhosis patients and €41,610 in HCV-HCC patients. The reliability of our results was confirmed by the one way sensitivity-analysis and by the cost-effectiveness acceptability curve that reported 97.5% probability of SOF/RBV to be cost-effective at a willingness to pay threshold of €60,000 in the HCV–cirrhosis scenario, and 88.1% in the HCV-HCC scenario. Further, SOF/RBV c
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- 2014
16. A value-based approach to the management of patients with liver cirrhosis through the systematic measurement of clinical outcome and quality of life indicators
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Okolicsanyi, S, Ciaccio, A, Cortesi, P, Rota, M, Gemma, M, Giani, P, Scalone, L, Mantovani, L, Fagiuoli, S, Valsecchi, M, Cesana, G, Belli, L, Strazzabosco, M, OKOLICSANYI, STEFANO, CIACCIO, ANTONIO, CORTESI, PAOLO ANGELO, ROTA, MATTEO, GEMMA, MARTA, SCALONE, LUCIANA, MANTOVANI, LORENZO GIOVANNI, VALSECCHI, MARIA GRAZIA, CESANA, GIANCARLO, Belli, LS, STRAZZABOSCO, MARIO, Okolicsanyi, S, Ciaccio, A, Cortesi, P, Rota, M, Gemma, M, Giani, P, Scalone, L, Mantovani, L, Fagiuoli, S, Valsecchi, M, Cesana, G, Belli, L, Strazzabosco, M, OKOLICSANYI, STEFANO, CIACCIO, ANTONIO, CORTESI, PAOLO ANGELO, ROTA, MATTEO, GEMMA, MARTA, SCALONE, LUCIANA, MANTOVANI, LORENZO GIOVANNI, VALSECCHI, MARIA GRAZIA, CESANA, GIANCARLO, Belli, LS, and STRAZZABOSCO, MARIO
- Abstract
Development of complications in liver cirrhosis (LC) is associated with increased mortality, hospital admissions and costs. Management of LC complications in clinical practice is well established, but the real value and effectiveness of care provided are still difficult to assess. Measurement of outcome indicators (OIs) together with patients-health related quality of life (p-HRQoL) could assist both clinicians and administrators in the process of care, in order to ensure greater quality in patients with LC. Aim of our study was to validate specific OIs, coupled with p-HRQoL scales, and apply them in the clinical assessment of compensated (CC) and decompensated cirrhosis (DC) management. A panel of hepatologists identified a set of OIs using published evidence, a modified Delphi method and a standard 9-point RAND appropriateness scale. These OIs were part of a larger effort, included in a prospective multicenter observational study (Value Based Medicine in Hepatology Study), involving three European tertiary clinical centers. P-HRQoL collected using the EQ-5D questionnaire, generated an health profile, by means of five utility domains (mobility, self care, anxiety/ depression, usual activities and pain/discomfort), and a visual analogue scale (VAS), which measured overall p-HRQoL in a range from 0 to 100. During 18 months we enrolled 1772 patients with LC: 1015 CC and 757 DC; the median follow-up time was 2 years. Results: the OIs chosen by the panelist were meant to evaluate the efficacy of care of major complications of LC: variceal bleeding occurred with an annual incidence of 3,1%, with 1-year survival of 76% of patients, and hepatocellular carcinoma (HCC) developed in a rate of 3,5% per year, with 83% CC patients diagnosed at early stage HCC. The strongest OIs according to the experts were decompensation rate in CC, which was 6.6% per year in our study, and overall survival in DC patients. The 1-year survival after the first decompensation episode (ascites in 7
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- 2014
17. Trattamento con Sofosbuvir e Ribavirina nei pazienti hcv-positivi listati per il trapianto di fegato: un analisi di costo-efficacia
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Cortesi, P, Mantovani, L, Ciaccio, A, Rota, M, Cesana, G, Strazzabosco, M, Belli, L, CORTESI, PAOLO ANGELO, CIACCIO, ANTONIO, ROTA, MATTEO, CESANA, GIANCARLO, STRAZZABOSCO, MARIO, MANTOVANI, LORENZO GIOVANNI, Belli, LS, Cortesi, P, Mantovani, L, Ciaccio, A, Rota, M, Cesana, G, Strazzabosco, M, Belli, L, CORTESI, PAOLO ANGELO, CIACCIO, ANTONIO, ROTA, MATTEO, CESANA, GIANCARLO, STRAZZABOSCO, MARIO, MANTOVANI, LORENZO GIOVANNI, and Belli, LS
- Abstract
INTRODUZIONE: Il virus dell'epatite C (HCV) è la principale indicazione per il trapianto di fegato, con una percentuale che varia dal 10% nei paesi dell'Europa settentrionale a quasi il 50% nei paesi dell’Europa meridionale. La prognosi dei pazienti affetti da HCV sottoposti a trapianto di fegato è gravemente limitata dall’alta probabilità di recidiva dell’HCV post-trapianto. L'unica opzione terapeutica disponibile attualmente per la recidiva da HCV è il trattamento con Peginterferone in combinazione con Ribavirina. Purtroppo, meno del 50% dei pazienti può effettivamente essere trattato con questi farmaci e il tasso di risposta tra i pazienti trattati è inferiore al 30%. Sofosbuvir in combinazione con ribavirina (SOF/RBV) è un nuovo trattamento senza interferone capace di sopprimere la viremia e prevenire la recidiva da HCV quando usato nei pazienti listati per il trapianto. L’obiettivo di questo studio è stato valutare la costo-efficacia del trattamento con SOF/RBV nei pazienti listati per il trapianto con diagnosi di cirrosi da HCV (HCV-cirrosi) o con diagnosi di epatocarcinoma da HCV (HCV-HCC). MATERIALI E METODI: Un modello analitico decisionale di semi-Markov è stato sviluppato per valutare la costo-efficacia del trattamento SOF/RBV nei pazienti listati per trapianto di fegato con HCV-cirrosi e in quelli con HCV-HCC. Il modello simula la progressione dei soggetti HCV-cirrosi o HCV-HCC dal momento del loro inserimento nella lista trapianti fino alla loro morte, considerando il rischio di recidiva da HCV post-trapianto. Con questo modello sono state confrontate due diverse strategie terapeutiche: 1) Trattamento con SOF/RBV fino a un massimo di 24 settimane o fino a trapianto se eseguito prima della 24° settimana dall’inizio del trattamento, 2) Nessun trattamento antivirale. Il modello ha stimato i costi relativi al trattamento con SOF/RBV, i costi associati a ciascun stato di salute, gli anni di vita (LYs), gli anni di vita aggiustati per la qualità (QA
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- 2014
18. The impact of liver disease on the health-related quality of life
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Cortesi, P, Rota, M, Scalone, L, Cozzolino, P, Cesana, G, Mantovani, L, Okolicsanyi, S, Ciaccio, A, Gemma, M, Fagiuoli, S, Valsecchi, M, Belli, L, Strazzabosco, M, CORTESI, PAOLO ANGELO, ROTA, MATTEO, SCALONE, LUCIANA, CESANA, GIANCARLO, MANTOVANI, LORENZO GIOVANNI, OKOLICSANYI, STEFANO, CIACCIO, ANTONIO, GEMMA, MARTA, VALSECCHI, MARIA GRAZIA, Belli, LS, STRAZZABOSCO, MARIO, Cortesi, P, Rota, M, Scalone, L, Cozzolino, P, Cesana, G, Mantovani, L, Okolicsanyi, S, Ciaccio, A, Gemma, M, Fagiuoli, S, Valsecchi, M, Belli, L, Strazzabosco, M, CORTESI, PAOLO ANGELO, ROTA, MATTEO, SCALONE, LUCIANA, CESANA, GIANCARLO, MANTOVANI, LORENZO GIOVANNI, OKOLICSANYI, STEFANO, CIACCIO, ANTONIO, GEMMA, MARTA, VALSECCHI, MARIA GRAZIA, Belli, LS, and STRAZZABOSCO, MARIO
- Abstract
The impact of liver diseases (LDs) on health-related quality of life (HRQoL) is an important aspect to understand the burden of these conditions and to improve their management. A well characterized impact of the major LDs on HRQoL of the general population is still lacking. The aim of our study was to fill this gap. A dataset with HRQoL data of a representative sample of the general population of most populated Italian region was matched with the dataset from a multicenter study conducted in the same region and time period to generate and validate a set of health care outcomes indicators for the major LDs (hepatitis B (HBV), hepatitis C (HCV), compensated cirrhosis (CC), decompensated cirrhosis (DC), hepatocellular carcinoma (HCC), autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), NAFLD/ NASH and patients listed for liver transplant (LTL)). Within both datasets, HRQoL data were collected using the EQ-5D-3L, a generic instrument that enables HRQoL to be compared within and between clinical conditions and with the general population. It generates a health profile made up of 5 domains (Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/ depression). It also consists of a visual analogue scale (EQ-5D VAS) which measures overall HRQoL. Further, results from the EQ-5D health profile can be converted to utility index, useful to conduct economic evaluations. Multivariate logistic and linear regressions were then performed adjusting for possible confounders (age, sex, education and working status). A total of 6,800 nullhealthy subjectsnull and 3,105 subjects with LDs (625 HCV, 287 HBV, 614 CC, 531 DC, 647 HCC, 59 LTL, 229 NAFLD/NASH, 68 PBC, 55 PSC, and 49 AIH) were included in the analyses. Multivariate logistic analyses showed that DC, HCC, and LTL had significantly (p<0.05) higher risk to have problems in mobility, self-care, and usual activities compared to nullhealthy subjectednull. AIH had significantly hig
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- 2014
19. GENOTYPE 2 AND 3 RECCURENT HEPATITIS C AFTER LIVER TRANSPLANTATION: EXCELLENT RESULTS WITH SUBOPTIMAL DOSES OF ANTIVIRAL THERAPY
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Vigano, R, Ponziani, F, Belli, L, Vangeli, M, Pinzello, G, Gasbarrini, A, Pasulo, L, De Martin, E, Burra, R, Pompili, M, Colledan, M, Cillo, U, Fagiuoli, S, Vigano R, Ponziani FR, Belli LS, Vangeli M, Pinzello G, Gasbarrini A, Pasulo L, De Martin E, Burra R, Pompili M, Colledan M, Cillo U, Fagiuoli S, Vigano, R, Ponziani, F, Belli, L, Vangeli, M, Pinzello, G, Gasbarrini, A, Pasulo, L, De Martin, E, Burra, R, Pompili, M, Colledan, M, Cillo, U, Fagiuoli, S, Vigano R, Ponziani FR, Belli LS, Vangeli M, Pinzello G, Gasbarrini A, Pasulo L, De Martin E, Burra R, Pompili M, Colledan M, Cillo U, and Fagiuoli S
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- 2009
20. THE BENEFIT OF ANTIVIRAL THERAPY ON FIBROSIS PROGRESSION DUE TO HCV RECURRENCE AFTER LIVER TRANSPLANTATION (LT): AN ITALIAN MULTICENTER STUDY
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De Martin, E, Senzolo, M, Ponziani, F, Vigano, R, Belli, L, Pinzello, G, Colledan, M, Donato, M, Di Paolo, D, Angelico, M, Rendina, M, Pompili, M, Merli, M, Villa, E, Russo, F, Boninsegna, S, Cillo, U, Gasbarrini, A, Toniutto, P, Fagiuoli, S, Burra, P, De Martin E, Senzolo M, Ponziani F, Vigano R, Belli LS, Pinzello G, Colledan M, Donato MF, Di Paolo D, Angelico M, Rendina M, Pompili M, Merli M, Villa E, Russo FP, Boninsegna S, Cillo U, Gasbarrini A, Toniutto P, Fagiuoli S, Burra P, De Martin, E, Senzolo, M, Ponziani, F, Vigano, R, Belli, L, Pinzello, G, Colledan, M, Donato, M, Di Paolo, D, Angelico, M, Rendina, M, Pompili, M, Merli, M, Villa, E, Russo, F, Boninsegna, S, Cillo, U, Gasbarrini, A, Toniutto, P, Fagiuoli, S, Burra, P, De Martin E, Senzolo M, Ponziani F, Vigano R, Belli LS, Pinzello G, Colledan M, Donato MF, Di Paolo D, Angelico M, Rendina M, Pompili M, Merli M, Villa E, Russo FP, Boninsegna S, Cillo U, Gasbarrini A, Toniutto P, Fagiuoli S, and Burra P
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- 2009
21. Hepatocellular carcinoma: Comparison between liver transplantation, resective surgery, ethanol injection, and chemoembolization
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Colella, G, Bottelli, R, De Carlis, L, Sansalone, C, Rondinara, G, Alberti, A, Belli, L, Gelosa, F, Iamoni, G, Rampoldi, A, De Gasperi, A, Corti, A, Mazza, E, Aseni, P, Meroni, A, Slim, A, Finzi, M, Di Benedetto, F, Manochehri, F, Follini, M, Ideo, G, Forti, D, Sansalone, CV, Rondinara, GF, Belli, LS, Iamoni, GM, Slim, AO, Follini, ML, Colella, G, Bottelli, R, De Carlis, L, Sansalone, C, Rondinara, G, Alberti, A, Belli, L, Gelosa, F, Iamoni, G, Rampoldi, A, De Gasperi, A, Corti, A, Mazza, E, Aseni, P, Meroni, A, Slim, A, Finzi, M, Di Benedetto, F, Manochehri, F, Follini, M, Ideo, G, Forti, D, Sansalone, CV, Rondinara, GF, Belli, LS, Iamoni, GM, Slim, AO, and Follini, ML
- Abstract
Between January 1989 and June 1997, 533 patients (423 male, 110 female, mean age 61 years, range 22-89 years) with hepatocellular carcinoma (HCC) were observed at our center. We report on 419 patients retrospectively compared for different treatments: liver transplantation (LT; 55 patients), resective surgery (RS; 41 patients), transarterial chemoembolization (TACE; 171 patients) and percutaneous ethanol injection (PEI; 152 patients). The 3- and 5-year actuarial survival rates were, respectively, 72% and 68% for LT, 64 and 44% for RS, 54 and 36% for PEI, and 32 and 22% for TACE. Survival curves were compared for sex, age, tumor characteristics, alphafetoprotein level, Child class, and etiology of cirrhosis. All patient-related characteristics examined (sex, age) are not significantly related to patient survival. Tumor-related variables and associated liver disease variables significantly conditioned survival in relation to different treatments. LT seems to be the treatment of choice for monofocal HCC less then 5 cm in diameter and in selected cases of plurifocal HCC. © Springer-Verlag 1998
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- 1998
22. Iliac artery graft interposition in liver transplantation: Our experience in 72 cases
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Sansalone, C, Colella, G, Rondinara, G, Rossetti, O, De Carlis, L, Belli, L, Meroni, A, Della Volpe, A, Trojsi, C, Sansalone, CV, Rondinara, GF, Belli, LS, Sansalone, C, Colella, G, Rondinara, G, Rossetti, O, De Carlis, L, Belli, L, Meroni, A, Della Volpe, A, Trojsi, C, Sansalone, CV, Rondinara, GF, and Belli, LS
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- 1994
23. Milan multicenter experience in 96 liver transplants for hepatitis B virus-related cirrhosis
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Caccamo, L, Belli, L, Mazzaferro, V, Colledan, M, Alberti, A, Regalia, E, Fassati, L, Ideo, G, Rubino, A, Gennari, L, Galmarini, D, Belli, LS, Fassati, LR, Caccamo, L, Belli, L, Mazzaferro, V, Colledan, M, Alberti, A, Regalia, E, Fassati, L, Ideo, G, Rubino, A, Gennari, L, Galmarini, D, Belli, LS, and Fassati, LR
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- 1994
24. The role of donor and recipient factors in initial renal graft non-function
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Belli, L, De Carlis, L, Del Favero, E, Civati, G, Brando, B, Romani, F, Aseni, P, Rondinara, G, Palmieri, B, Meroni, A, Belli, LS, Rondinara, GF, Palmieri, B., Belli, L, De Carlis, L, Del Favero, E, Civati, G, Brando, B, Romani, F, Aseni, P, Rondinara, G, Palmieri, B, Meroni, A, Belli, LS, Rondinara, GF, and Palmieri, B.
- Abstract
Delayed renal graft function appears to be a complex multifactorial disease that has been related to the premortem condition of the donor total ischemia time (cold or warm), methods of preservation, and surgical harvesting procedure. Perioperative recipient management, recipient variables, and immunologically mediated early injuries have also been implicated. An increased interest in the detection of the possible causes of initial graft nonfunction (IGNF) was recently related to the usual practice of multiorgan procurement. Therefore, we retrospectively investigated the incidence of IGNF in our Department, analyzing the records of 90 consecutive renal donors and recipients with particular attention to the fate of the two harvested kidneys (twin kidney), and comparing the results from multiple organ donors (MOD) with those achieved from single organ donors (SOD)
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- 1988
25. Thromboendoarterectomy (TEA) in the recipient as a major risk of arterial complication after kidney transplantation
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Belli, L, De Carlis, L, Del Favero, E, Puttini, M, Aseni, P, Rondinaria, G, Meroni, A, Beati, C, Belli, LS, Rondinaria, GF, Belli, L, De Carlis, L, Del Favero, E, Puttini, M, Aseni, P, Rondinaria, G, Meroni, A, Beati, C, Belli, LS, and Rondinaria, GF
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- 1989
26. Kidney and liver initial graft function under different procurement techniques
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Belli, L, De Carlis, L, Romani, F, Rondinara, G, Degna, C, Brando, B, Del Favero, E, Palmieri, B, Meroni, A, Frangi, M, Belli, LS, Rondinara, GF, Degna, CT, Belli, L, De Carlis, L, Romani, F, Rondinara, G, Degna, C, Brando, B, Del Favero, E, Palmieri, B, Meroni, A, Frangi, M, Belli, LS, Rondinara, GF, and Degna, CT
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- 1989
27. Hepatitis C virus recurrence after liver transplantation: a 10-year evaluation
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Roberto Di Donato, Mauro Bernardi, Marcello Vangeli, Antonio Daniele Pinna, Luciano De Carlis, Luca S. Belli, Stefania Lorenzini, Ranka Vukotic, Arrigo F G Cicero, Matteo Cescon, Arianna Martello Panno, Pietro Andreone, Gian Luca Grazi, Stefano Gitto, Aldo Airoldi, Lucia Brodosi, Gitto S, Belli LS, Vukotic R, Lorenzini S, Airoldi A, Cicero AF, Vangeli M, Brodosi L, Martello Panno A, Di Donato R, Cescon M, Grazi GL, De Carlis L, Pinna AD, Bernardi M, Andreone P., Gitto, S, Belli, L, Vukotic, R, Lorenzini, S, Airoldi, A, Cicero, A, Vangeli, M, Brodosi, L, Panno, A, Di Donato, R, Cescon, M, Grazi, G, De Carlis, L, Pinna, A, Bernardi, M, and Andreone, P
- Subjects
Male ,Time Factors ,medicine.medical_treatment ,Hepacivirus ,Kaplan-Meier Estimate ,Liver transplantation ,Ten-year survival ,Gastroenterology ,Risk Factors ,Recurrence ,Retrospective Studie ,Odds Ratio ,Multivariate Analysi ,General Medicine ,Hepatitis C ,Middle Aged ,Exact test ,Treatment Outcome ,Italy ,ANTIVIRAL TERAPHY ,HEPATITIS C ,SURVIVAL ,Drug Therapy, Combination ,Female ,Viral hepatitis ,LIVER TRANSPLANTATION ,HEPATITIS C RECURRENCE ,Human ,Adult ,medicine.medical_specialty ,Logistic Model ,Time Factor ,Antiviral treatment ,Hepatitis C virus recurrence ,Antiviral Agents ,NO ,Hepatitis C, Liver transplantation, hepatitis C virus recurrence, Antiviral treatment, Ten-year survival ,End Stage Liver Disease ,Internal medicine ,medicine ,Humans ,Retrospective Cohort Study ,Survival rate ,Survival analysis ,Proportional Hazards Models ,Retrospective Studies ,Antiviral Agent ,Chi-Square Distribution ,Hepaciviru ,Proportional hazards model ,business.industry ,Risk Factor ,medicine.disease ,Surgery ,Transplantation ,Logistic Models ,Multivariate Analysis ,Proportional Hazards Model ,Virus Activation ,business - Abstract
AIM: To evaluate the predictors of 10-year survival of patients with hepatitis C recurrence. /// METHODS: Data from 358 patients transplanted between 1989 and 2010 in two Italian transplant centers and with evidence of hepatitis C recurrence were analyzed. A χ 2, Fisher's exact test and Kruskal Wallis' test were used for categorical and continuous variables, respectively. Survival analysis was performed at 10 years after transplant using the Kaplan-Meier method, and a log-rank test was used to compare groups. A p level less than 0.05 was considered significant for all tests. Multivariate analysis of the predictive role of different variables on 10-year survival was performed by a stepwise Cox logistic regression./// RESULTS: The ten-year survival of the entire popu lation was 61.2%. Five groups of patients were identified according to the virological response or lack of a response to antiviral treatment and, among those who were not treated, according to the clinical status (mild hepatitis C recurrence, "too sick to be treated" and patients with comorbidities contraindicating the treatment). While the 10-year survival of treated and untreated patients was not different (59.1% vs 64.7%, p = 0.192), patients with a sustained virological response had a higher 10-year survival rate than both the "non-responders" (84.7% vs 39.8%, p < 0.0001) and too sick to be treated (84.7% vs 0%, p < 0.0001). Sustained virological responders had a survival rate comparable to patients untreated with mild recurrence (84.7% vs 89.3%). A sustained virological response and young donor age were independent predictors of 10-year survival./// CONCLUSION: Sustained virological response significantly increased long-term survival. Awaiting the interferon-free regimen global availability, antiviral treatment might be questionable in selected subjects with mild hepatitis C recurrence.
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- 2015
28. Statin therapy: improving survival in patients with hepatocellular carcinoma and portal hypertension is possible?
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Dispinzieri G, Becchetti C, Mazzarelli C, Airoldi A, Aprile F, Cesarini L, Cucco M, Perricone G, Stigliano R, Vangeli M, Viganò R, and Belli LS
- Subjects
- Humans, Hypertension, Portal drug therapy, Hypertension, Portal etiology, Carcinoma, Hepatocellular drug therapy, Carcinoma, Hepatocellular mortality, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Liver Neoplasms drug therapy
- Abstract
Statins are generally known for their lipid-lowering properties and protection against cardiovascular events. However, growing evidence suggests that statins are a promising treatment for patients with chronic liver disease. Specifically, there is data supporting their role in reducing portal pressure and having a chemopreventive effect on hepatocellular carcinoma (HCC). Treatment options for HCC remain limited with portal hypertension (PH), thus statins could represent an inexpensive alternative, increasing survival of patients with HCC and PH. These drugs cannot be considered standard of care without a cardiac-metabolic indication to prescription in this patient group, although the potential beneficial effect should be indication for prompt use whenever considered appropriate. Our aim is to review the effects of statins on PH and on HCC, both in the pre-clinical and clinical setting in literature, discussing safety issues and limitations to the current body of evidence., Competing Interests: The authors declare that they have no conflict of interest, (© Acta Gastro-Enterologica Belgica.)
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- 2024
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29. Worldwide variations in COVID-19 vaccination policies and practices in liver transplant settings: results of a multi-society global survey.
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Di Maira T, Vinaixa C, Izzy M, Paolo Russo F, Kirchner VA, Rammohan A, Belli LS, Polak WG, Berg T, and Berenguer M
- Abstract
Background: Despite the WHO's report of 24 available SARS-CoV-2 vaccines, limited data exist regarding vaccination policies for liver transplant (LT) patients. To address this, we conducted a global multi-society survey (EASL-ESOT-ELITA-ILTS) in LT centers., Methods: A digital questionnaire assessing vaccine policies, safety, efficacy, and center data was administered online to LT centers., Results: Out of 168 responding centers, 46.4%, 28%, 13.1%, 10.7%, and 1.8% were from European, American, Western Pacific, Southeast Asian, and Eastern Mediterranean Regions. Most LT centers prioritized COVID-19 vaccine access for LT patients (76%) and healthcare workers (86%), while other categories had lower priority (30%). One-third of responders recommended mRNA vaccine exclusively, while booster doses were widely recommended (81%). One-third conducted post-vaccine liver function tests post COVID-19 vaccine. Only 16% of centers modified immunosuppression, and mycophenolate discontinuation or modification was the main approach. Side effects were seen in 1 in 1,000 vaccinated patients, with thromboembolism, acute rejection, and allergic reaction being the most severe. mRNA showed fewer side effects (-3.1, p = 0.002)., Conclusion: COVID-19 vaccines and booster doses were widely used among LT recipients and healthcare workers, without a specific vaccine preference. Preventative immunosuppression adjustment post-vaccination was uncommon. mRNA vaccines demonstrated a favorable safety profile in this population., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Di Maira, Vinaixa, Izzy, Paolo Russo, Kirchner, Rammohan, Belli, Polak, Berg and Berenguer.)
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- 2024
- Full Text
- View/download PDF
30. Liver Transplantation for Primary Sclerosing Cholangitis (PSC) With or Without Inflammatory Bowel Disease (IBD)-A European Society of Organ Transplantation (ESOT) Consensus Statement.
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Carbone M, Della Penna A, Mazzarelli C, De Martin E, Villard C, Bergquist A, Line PD, Neuberger JM, Al-Shakhshir S, Trivedi PJ, Baumann U, Cristoferi L, Hov J, Fischler B, Hadzic NH, Debray D, D'Antiga L, Selzner N, Belli LS, and Nadalin S
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- Humans, Risk Factors, Immunosuppressive Agents therapeutic use, Liver Transplantation, Cholangitis, Sclerosing complications, Cholangitis, Sclerosing surgery, Inflammatory Bowel Diseases complications, Inflammatory Bowel Diseases surgery
- Abstract
Primary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD) and a lead indication for liver transplantation (LT) in the western world. In this article, we present a Consensus Statement on LT practice, developed by a dedicated Guidelines' Taskforce of the European Society of Organ Transplantation (ESOT). The overarching goal is to provide practical guidance on commonly debated topics, including indications and timing of LT, management of bile duct stenosis in patients on the transplant waiting list, technical aspects of transplantation, immunosuppressive strategies post-transplant, timing and extension of intestinal resection and futility criteria for re-transplantation., Competing Interests: MC has received grant support unrelated to this study from Genetics spa, PSC Pediatric Foundation, AMAF, EpaC and AIRCS. He also received speakers/consultancy/advisory fees for GlaxoSmithKline, Dr. Falk Pharma, Cymabay, Advanz Pharma, Albireo, Ipsen, Mayoly Spindler, Perspectum, Echosens, Kowa, and Mirun. PT receives institutional support from Birmingham NIHR BRC. Unrelated to this study PT has received grant support from the Wellcome Trust, Innovate UK, the Medical Research Foundation, GlaxoSmithKline (GSK), Guts UK, PSC Support, LifeArc, NIHR, Intercept Pharma, Dr. Falk Pharma, Gilead Sciences, and Bristol Myers Squibb. He has also received speaker fees from Intercept and Dr. Falk, and advisory board/consultancy fees from Intercept, Cymabay, Pliant Pharma, Dr. Falk, Albireo, Ipsen and GlaxoSmithKine. HNH consultancies for Arrowhead, Takeda, GLG, Albireo, Alnylam and Mirum. LC received speakers fee from Advanz and Echosens. LD’A received consultancy fees from: Albireo, Mirum, Alexion, Astra Zeneca, Selecta, Vivet, Spark, Genespire, and Tome, in fields unrelated to the current topic. DD received consultancy fees from: Mirum, Vertex, Orphalan, Univar, Alexion, in fields unrelated to this study. UB received consultancy fees or grant support from: Mirum, Albireo, Alexion, Nestle and Vivet in fields unrelated to this study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Carbone, Della Penna, Mazzarelli, De Martin, Villard, Bergquist, Line, Neuberger, Al-Shakhshir, Trivedi, Baumann, Cristoferi, Hov, Fischler, Hadzic, Debray, D’Antiga, Selzner, Belli and Nadalin.)
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- 2023
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31. Economic Impact of European Liver and Intestine Transplantation Association (ELITA) Recommendations for Hepatitis B Prophylaxis After Liver Transplantation.
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Cortesi PA, Viganò R, Conti S, Lenci I, Volpes R, Martini S, Angelico M, Fung J, Buti M, Coilly A, Durand F, Fondevila C, Lebray P, Nevens F, Polak WG, Rizzetto M, Zoulim F, Perricone G, Berenguer M, Mantovani LG, Duvoux C, and Belli LS
- Subjects
- Humans, Antiviral Agents therapeutic use, Drug Therapy, Combination, Liver Transplantation, Hepatitis B prevention & control
- Abstract
The European Liver and Intestine Transplant Association, ELITA, promoted a Consensus Conference involving 20 experts across the world which generated updated guidelines on HBV prophylaxis in liver transplant candidates and recipients. This study explores the economic impact associated with the implementation of the new ELITA guidelines. To this aim, a condition-specific cohort simulation model has been developed to compare new and historical prophylaxis, including only pharmaceutical cost and using the European perspective. The target population simulated in the model included both prevalent and incident cases, and consisted of 6,133 patients after the first year, that increased to 7,442 and 8,743 patents after 5 and 10 years from its implementation. The ELITA protocols allowed a cost saving of around € 235.65 million after 5 years and € 540.73 million after 10 years; which was mainly due to early HIBG withdrawal either after the first 4 weeks or after the first year post Liver Transplantation (LT) depending on the virological risk at transplantation. Results were confirmed by sensitivity analyses. The money saved by the implementation of the ELITA guidelines would allow healthcare decision makers and budget holders to understand where costs could be reduced and resources re-allocated to different needs., Competing Interests: PC has served as a speaker for Novartis and Roche. CD has served as a speaker, a consultant and an advisory board member for Astellas, Biotest, Chiesi, Novartis and Sandoz and has received research funding from Novartis and Sandoz. MA has served as a speaker, a consultant and an advisory board member for Abbvie and Gilead and has received research funding from Gilead and MSD. MB1 has served as a speaker, a consultant and an advisory board member for Abbvie, Astellas, Deep-Genomic, Gilead, Intercept, Orphalan, Novartis, and has received research funding from Gilead. MB2 has served as a speaker and an advisory board member for Gilead and Janseen and has received funding from Abbvie and Gilead. AC has served as a speaker, a consultant and an advisory board member for Astellas, Novartis, Sandoz, Intercept, Gilead and has received research funding from Intercept. FD has served as a consultant for Biotest. CF has served as a speaker, a consultant and an advisory board member for Astellas, Corza Medical and Medtronic, and has received research funding from Guangdong Shunde Innovative Design Institute, Guangdong, China. PL has reported grants (research funding) from Biotest France SAS and non-financial support (financial and logistic participation for Liver Congress) from Biotest France SAS and Gilead. LM reported receiving grants from Bayer, Daiiki-Sankyo, and Boehringer Ingelheim outside the submitted work and speaker fees from Pfizer and Bayer. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Cortesi, Viganò, Conti, Lenci, Volpes, Martini, Angelico, Fung, Buti, Coilly, Durand, Fondevila, Lebray, Nevens, Polak, Rizzetto, Zoulim, Perricone, Berenguer, Mantovani, Duvoux and Belli.)
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- 2023
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32. ESOT Consensus Platform for Organ Transplantation: Setting the Stage for a Rigorous, Regularly Updated Development Process.
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Cillo U, Weissenbacher A, Pengel L, Jochmans I, Roppolo D, Amarelli C, Belli LS, Berenguer M, De Vries A, Ferrer J, Friedewald J, Furian L, Greenwood S, Monbaliu D, Nadalin S, Neyrinck A, Strazzabosco M, Toso C, Zaza G, Thuraisingham R, Berney T, Potena L, Montserrat N, and Selzner N
- Subjects
- Humans, Consensus, Societies, Medical, Organ Transplantation
- Abstract
The European Society for Organ Transplantation (ESOT) has created a platform for the development of rigorous and regularly updated evidence based guidelines for clinical practice in the transplantation field. A dedicated Guideline Taskforce, including ESOT-council members, a representative from the Centre for Evidence in Transplantation, editors of the journal Transplant International has developed transparent procedures to guide the development of guidelines, recommendations, and consensus statements. During ESOT's first Consensus Conference in November 2022, leading experts will present in-depth evidence based reviews of nine themes and will propose recommendations aimed at reaching a consensus after public discussion and assessment by an independent jury. All recommendations and consensus statements produced for the nine selected topics will be published including the entire evidence-based consensus-finding process. An extensive literature review of each topic was conducted to provide final evidence and/or expert opinion., Competing Interests: IJ received speaker fees from XVIVO perfusion paid to her institution. IJ is an ESOT Councilor for which she receives no reimbursement. JFe is recipient of a grant supported by Instituto de Salud Carlos III (ISCIII) through the project “PI18/00161 (Optimization of pancreas transplant graft: A multicentric study of histo-morphological and functional characteristics of unaccepted organs.)” and co-funded by the European Union. AdV received in the past speaker and consultation fees from Astellas, Chiesi, Hansa, Novartis, Sandoz, CSL Behring all of which paid to his institution. AdV is chair of the Dutch Kidney Advisory Committee (Landelijk Overleg NierTransplantatie LONT) for which he receives no reimbursement. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Cillo, Weissenbacher, Pengel, Jochmans, Roppolo, Amarelli, Belli, Berenguer, De Vries, Ferrer, Friedewald, Furian, Greenwood, Monbaliu, Nadalin, Neyrinck, Strazzabosco, Toso, Zaza, Thuraisingham, Berney, Potena, Montserrat and Selzner.)
- Published
- 2022
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33. Liver transplantation for severe alcoholic hepatitis: A multicenter Italian study.
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Germani G, Angrisani D, Addolorato G, Merli M, Mazzarelli C, Tarli C, Lattanzi B, Panariello A, Prandoni P, Craxì L, Forza G, Feltrin A, Ronzan A, Feltracco P, Grieco A, Agnes S, Gasbarrini A, Rossi M, De Carlis L, Francesco D, Cillo U, Belli LS, and Burra P
- Subjects
- Female, Humans, Male, Middle Aged, Patient Selection, Recurrence, Waiting Lists, Hepatitis, Alcoholic surgery, Liver Transplantation
- Abstract
There is increasing evidence that early liver transplantation (eLT), performed within standardized protocols can improve survival in severe alcoholic hepatitis (sAH). The aim of the study was to assess outcomes after eLT for sAH in four Italian LT centers and to compare them with non-responders to medical therapy excluded from eLT. Patients admitted for sAH (2013-2019), according to NIAAA criteria, were included. Patients not responding to medical therapy were placed on the waiting list for eLT after a strict selection. Histological features of explanted livers were evaluated. Posttransplant survival and alcohol relapse were evaluated. Ninety-three patients with severe AH were evaluated (65.6% male, median [IQR] age: 47 [42-56] years). Forty-five of 93 patients received corticosteroids, 52 of 93 were non-responders and among these, 20 patients were waitlisted. Sixteen patients underwent LT. Overall, 6-, 12-, and 24-month survival rates were 100% significantly higher compared with non-responders to medical therapy who were denied LT (45%, 45%, and 36%; p < .001). 2/16 patients resumed alcohol intake, one at 164 days and one at 184 days. Early LT significantly improves survival in sAH non-responding to medical therapy, when a strict selection process is applied. Further studies are needed to properly assess alcohol relapse rates., (© 2021 The American Society of Transplantation and the American Society of Transplant Surgeons.)
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- 2022
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34. 2020 position statement and recommendations of the European Liver and Intestine Transplantation Association (ELITA): management of hepatitis B virus-related infection before and after liver transplantation.
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Duvoux C, Belli LS, Fung J, Angelico M, Buti M, Coilly A, Cortesi P, Durand F, Féray C, Fondevila C, Lebray P, Martini S, Nevens F, Polak WG, Rizzetto M, Volpes R, Zoulim F, Samuel D, and Berenguer M
- Subjects
- Antiviral Agents therapeutic use, Hepatitis B virus, Humans, Immunoglobulins therapeutic use, Neoplasm Recurrence, Local drug therapy, Recurrence, Treatment Outcome, Carcinoma, Hepatocellular drug therapy, Hepatitis B drug therapy, Hepatitis B prevention & control, Liver Neoplasms drug therapy, Liver Transplantation adverse effects
- Abstract
Background: Prophylaxis of HBV recurrence is critical after liver transplantation in HBV patients. Despite new prophylactic schemes, most European LT centres persist on a conservative approach combining hepatitis B immunoglobulin (HBIG) and nucleos(t)ides analogues (NA)., Aim: This setting prompted the European Liver Intestine Transplantation Association (ELITA) to look for a consensus on the prevention of HBV recurrence., Methods: Based on a 4-round Delphi process, ELITA investigated 16 research questions and established 50 recommendations., Results: Prophylaxis should be driven according to 3 simplified risk groups: Low and high virological risk patients, with undetectable and detectable HBV DNA pre-LT, respectively, and special populations (HDV, HCC, poorly adherent patients). In low-risk patients, short-term (4 weeks) combination of third-generation NA+ HBIG, or third generation NA monotherapy can be considered as prophylactic options. In high-risk patients, HBIG can be discontinued once HBV DNA undetectable. Combined therapy for 1 year is advised. HBV-HCC patients should be treated according to their virological risk. In HDV/HBV patients, indefinite dual prophylaxis remains the gold standard. Full withdrawal of HBV prophylaxis following or not HBV vaccination should only be attempted in the setting of clinical trials. Organs from HBsAg+ve donors may be considered after assessment of risks, benefits, and patient consent. They should not be used if HDV is present. In poorly adherent patients, dual long-term prophylaxis is recommended. Budget impact analysis should be taken into account to drive prophylactic regimen., Conclusions: These ELITA recommendations should stimulate a more rational and homogeneous approach to HBV prophylaxis across LT programs., (© 2021 John Wiley & Sons Ltd.)
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- 2021
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35. Reply.
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Belli LS, Conti S, and Polak W
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- 2021
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36. Measurement of Gamma Glutamyl Transferase to Determine Risk of Liver Transplantation or Death in Patients With Primary Biliary Cholangitis.
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Gerussi A, Bernasconi DP, O'Donnell SE, Lammers WJ, Van Buuren H, Hirschfield G, Janssen H, Corpechot C, Reig A, Pares A, Battezzati PM, Zuin MG, Cazzagon N, Floreani A, Nevens F, Gatselis N, Dalekos G, Mayo MJ, Thorburn D, Bruns T, Mason AL, Verhelst X, Kowdley K, van der Meer A, Niro GA, Beretta-Piccoli BT, Marzioni M, Belli LS, Marra F, Valsecchi MG, Lindor KD, Invernizzi P, Hansen BE, and Carbone M
- Subjects
- Female, Humans, Prognosis, gamma-Glutamyltransferase, Cholestasis, Liver Cirrhosis, Biliary, Liver Transplantation
- Abstract
Background & Aims: Gamma-glutamyltransferase (GGT) is a serum marker of cholestasis. We investigated whether serum level of GGT is a prognostic marker for patients with primary biliary cholangitis (PBC)., Methods: We analyzed data from patients with PBC from the Global PBC Study Group, comprising 14 centers in Europe and North America. We obtained measurements of serum GGT at baseline and time points after treatment. We used Cox model hazard ratios to evaluate the association between GGT and clinical outcomes, including liver transplantation and liver-related death., Results: Of the 2129 patients included in our analysis, 281 (13%) had a liver-related clinical endpoint. Mean age at diagnosis was 53 years and 91% of patients were female patients. We found a correlation between serum levels of GGT and alkaline phosphatase (ALP) (r = 0.71). Based on data collected at baseline and yearly for up to 5 years, higher serum levels of GGT were associated with lower hazard for transplant-free survival. Serum level of GGT at 12 months after treatment higher than 3.2-fold the upper limit of normal (ULN) identified patients who required liver transplantation or with liver-related death at 10 years with an area under the receiver operating characteristic curve of 0.70. The risk of liver transplantation or liver-related death in patients with serum level of GGT above 3.2-fold the ULN, despite level of ALP lower than 1.5-fold the ULN, was higher compared to patients with level of GGT lower than 3.2-fold the ULN and level of ALP lower than 1.5-fold the ULN (P < .05). Including information on level of GGT increased the prognostic value of the Globe score., Conclusions: Serum level of GGT can be used to identify patients with PBC at risk for liver transplantation or death, and increase the prognostic value of ALP measurement. Our findings support the use of GGT as primary clinical endpoint in clinical trials. In patients with low serum level of ALP, a high level of GGT identifies those who might require treatment of metabolic disorders or PBC treatment escalation., (Copyright © 2021 AGA Institute. Published by Elsevier Inc. All rights reserved.)
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- 2021
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37. Reply to Rodriguez-Peralvarez et al.
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Polak WG, Fondevila C, Karam V, Adam R, Belli LS, and Duvoux C
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- Europe, Humans, Intestines, Liver, Registries, SARS-CoV-2, COVID-19, Liver Transplantation
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- 2020
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38. Impact of COVID-19 on liver transplantation in Europe: alert from an early survey of European Liver and Intestine Transplantation Association and European Liver Transplant Registry.
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Polak WG, Fondevila C, Karam V, Adam R, Baumann U, Germani G, Nadalin S, Taimr P, Toso C, Troisi RI, Zieniewicz K, Belli LS, and Duvoux C
- Subjects
- COVID-19 diagnosis, COVID-19 Testing, Comorbidity, Donor Selection standards, Early Diagnosis, Europe epidemiology, Health Care Surveys, Humans, Immunocompromised Host, Incidence, Liver Diseases surgery, Mass Screening, Postoperative Complications epidemiology, Procedures and Techniques Utilization, Registries, Risk, Tissue Donors statistics & numerical data, Transplant Recipients statistics & numerical data, COVID-19 epidemiology, Liver Diseases epidemiology, Liver Transplantation statistics & numerical data, Pandemics, SARS-CoV-2
- Abstract
There are scarce data on the impact of COVID-19 pandemic on liver transplantation (LT) in Europe. The aim of this study was to obtain a preliminary data on incidence, management, and outcome of COVID-19 in liver transplant recipients and candidates in Europe. An Internet-based survey was sent to the centers affiliated with European Liver Transplant Registry (ELTR). One hundred nine out of 149 (73%) of ELTR centers located in 28 European countries (93%) responded. Ninety-four (86%) of the centers tested all donors, and 75 (69%) centers tested all LT recipients for SARS-CoV-2. Seventy-three (67%) centers selected recipients for LT in the COVID-19 pandemic, whereas 33% did not. Eighty-eight centers reported COVID-19 infection in 57 LT candidates and in 272 LT recipients. Overall crude incidence of COVID-19 among LT candidates and recipients was estimated 1.05% (range 0.5-20%) and 0.34% (range 0.1-4.8%), respectively, and it was significantly higher among candidates (P < 0.001). Crude rate of death was 18% (10/57) among candidates and 15% (36/244) among recipients. This first large-scale European snapshot study clearly shows that both LT candidates and recipients are at a high risk for COVID-19. These results plead for an early and pro-active screening of COVID-19 symptoms in these populations., (© 2020 Steunstichting ESOT. Published by John Wiley & Sons Ltd.)
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- 2020
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39. Clinical outcome in solid organ transplant recipients with COVID-19: A single-center experience.
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Travi G, Rossotti R, Merli M, Sacco A, Perricone G, Lauterio A, Colombo VG, De Carlis L, Frigerio M, Minetti E, Belli LS, and Puoti M
- Subjects
- Betacoronavirus, COVID-19, Humans, SARS-CoV-2, Spain, Coronavirus Infections, Organ Transplantation, Pandemics, Pneumonia, Viral, Transplant Recipients
- Published
- 2020
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40. Under-dilated TIPS Associate With Efficacy and Reduced Encephalopathy in a Prospective, Non-randomized Study of Patients With Cirrhosis.
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Schepis F, Vizzutti F, Garcia-Tsao G, Marzocchi G, Rega L, De Maria N, Di Maira T, Gitto S, Caporali C, Colopi S, De Santis M, Arena U, Rampoldi A, Airoldi A, Cannavale A, Fanelli F, Mosconi C, Renzulli M, Agazzi R, Nani R, Quaretti P, Fiorina I, Moramarco L, Miraglia R, Luca A, Bruno R, Fagiuoli S, Golfieri R, Torricelli P, Di Benedetto F, Belli LS, Banchelli F, Laffi G, Marra F, and Villa E
- Subjects
- Aged, Fibrosis surgery, Humans, Incidence, Italy epidemiology, Male, Middle Aged, Prospective Studies, Treatment Outcome, Fibrosis complications, Hepatic Encephalopathy epidemiology, Hepatic Encephalopathy prevention & control, Portasystemic Shunt, Transjugular Intrahepatic adverse effects, Portasystemic Shunt, Transjugular Intrahepatic methods
- Abstract
Background & Aims: Portosystemic encephalopathy (PSE) is a major complication of trans-jugular intrahepatic porto-systemic shunt (TIPS) placement. Most devices are self-expandable polytetrafluoroethylene-covered stent grafts (PTFE-SGs) that are dilated to their nominal diameter (8 or 10 mm). We investigated whether PTFE-SGs dilated to a smaller caliber (under-dilated TIPS) reduce PSE yet maintain clinical and hemodynamic efficacy. We also studied whether under-dilated TIPS self-expand to nominal diameter over time., Methods: We performed a prospective, non-randomized study of 42 unselected patients with cirrhosis who received under-dilated TIPS (7 and 6 mm) and 53 patients who received PTFE-SGs of 8 mm or more (controls) at referral centers in Italy. After completion of this study, dilation to 6 mm became the standard and 47 patients were included in a validation study. All patients were followed for 6 months; Doppler ultrasonography was performed 2 weeks and 3 months after TIPS placement and every 6 months thereafter. Stability of PTFE-SG diameter was evaluated by computed tomography analysis of 226 patients with cirrhosis whose stent grafts increased to 6, 7, 8, 9, or 10 mm. The primary outcomes were incidence of at least 1 episode of PSE grade 2 or higher during follow up, incidence of recurrent variceal hemorrhage or ascites, incidence of shunt dysfunction requiring TIPS recanalization, and reduction in porto-caval pressure gradient., Results: PSE developed in a significantly lower proportion of patients with under-dilated TIPS (27%) than controls (54%) during the first year after the procedure (P = .015), but the proportions of patients with recurrent variceal hemorrhage or ascites did not differ significantly between groups. No TIPS occlusions were observed. These results were confirmed in the validation cohort. In an analysis of self-expansion of stent grafts, during a mean follow-up period of 252 days after placement, none of the PTFE-SGs self-expanded to the nominal diameter in hemodynamically relevant sites (such as portal and hepatic vein vascular walls)., Conclusions: In prospective, non-randomized study of patients with cirrhosis, we found under-dilation of PTFE-SGs during TIPS placement to be feasible, associated with lower rates of PSE, and effective., (Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Published
- 2018
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41. Optimising the clinical strategy for autoimmune liver diseases: Principles of value-based medicine.
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Carbone M, Cristoferi L, Cortesi PA, Rota M, Ciaccio A, Okolicsanyi S, Gemma M, Scalone L, Cesana G, Fabris L, Colledan M, Fagiuoli S, Ideo G, Belli LS, Munari LM, Mantovani L, and Strazzabosco M
- Subjects
- Adult, Aged, Autoimmune Diseases epidemiology, Cholangitis, Sclerosing epidemiology, Critical Pathways organization & administration, Delphi Technique, Female, Follow-Up Studies, Hepatitis, Autoimmune epidemiology, Humans, Incidence, Italy epidemiology, Male, Middle Aged, Prospective Studies, Survival Analysis, Tertiary Care Centers statistics & numerical data, Autoimmune Diseases therapy, Cholangitis, Sclerosing therapy, Hepatitis, Autoimmune therapy, Outcome Assessment, Health Care methods, Quality Indicators, Health Care
- Abstract
Background: Autoimmune hepatitis, primary biliary cholangitis, and primary sclerosing cholangitis represent the three major autoimmune liver diseases (AILDs). Their management is highly specialized, requires a multidisciplinary approach and often relies on expensive, orphan drugs. Unfortunately, their treatment is often unsatisfactory, and the care pathway heterogeneous across different centers. Disease-specific clinical outcome indicators (COIs) able to evaluate the whole cycle of care are needed to assist both clinicians and administrators in improving quality and value of care. Aim of our study was to generate a set of COIs for the three AILDs. We then prospectively validated these indicators based on a series of consecutive patients recruited at three tertiary clinical centers in Lombardy, Italy., Methods: In phase I using a Delphi method and a RAND 9-point appropriateness scale a set of COIs was generated. In phase II the indicators were applied in a real-life dataset., Results: Two-hundred fourteen patients were enrolled and followed-up for a median time of 54months and the above COIs were recorded using a web-based electronic medical record program. The COIs were easy to collect in the clinical practice environment and their values compared well with the available natural history studies., Conclusions: We have generated a comprehensive set of COIs which sequentially capture different clinical outcome of the three AILDs explored. These indicators represent a critical tool to implement a value-based approach to patients with these conditions, to monitor, compare and improve quality through benchmarking of clinical performance and to assess the significance of novel drugs and technologies. This article is part of a Special Issue entitled: Cholangiocytes in Health and Diseaseedited by Jesus Banales, Marco Marzioni, Nicholas LaRusso and Peter Jansen., (Copyright © 2017. Published by Elsevier B.V.)
- Published
- 2018
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42. Cost-Effectiveness of New Direct-Acting Antivirals to Prevent Post-Liver Transplant Recurrent Hepatitis.
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Cortesi PA, Mantovani LG, Ciaccio A, Rota M, Mazzarelli C, Cesana G, Strazzabosco M, and Belli LS
- Subjects
- Aged, Antiviral Agents therapeutic use, Female, Follow-Up Studies, Hepatitis C complications, Humans, Male, Middle Aged, Prognosis, Quality-Adjusted Life Years, Recurrence, Antiviral Agents economics, Cost-Benefit Analysis, Hepacivirus pathogenicity, Hepatitis C economics, Hepatitis C prevention & control, Liver Transplantation adverse effects, Postoperative Complications
- Abstract
Preliminary studies on HCV-cirrhotics listed for transplant suggest that sofosbuvir in combination with ribavirin is very effective in promoting viral clearance and preventing disease recurrence. Unfortunately, the high cost of such treatment (€46 500 per 12 weeks of treatment) makes its cost-effectiveness questionable. A semi-Markov model was developed to assess the cost-effectiveness of sofosbuvir/ribavirin treatment in cirrhotic patients without HCC (HCV-CIRRH) and with HCC (HCV-HCC) listed for transplant. In the base-case analysis, the incremental cost-effectiveness ratio for 24 weeks of sofosbuvir/ribavirin was €44 875 per quality-adjusted life-year gained in HCV-CIRRH and €60 380 in HCV-HCC patients. Both results were above the willingness to pay threshold of €37 000 per quality-adjusted life-year. Our data also show that in order to remain cost-effective (with a 24-week treatment), any novel interferon-free treatment endowed with ideal efficacy should cost less than €67 224 or €95 712 in HCV-cirrhotics with and without HCC, respectively. The results shows that sofosbuvir/ribavirin therapy, given to patients listed for transplant, is not cost-effective at current prices despite being very effective, and new, more effective treatments will have little economic margins to remain cost-effective. New interferon-free combinations have the potential to revolutionize the treatment and prognosis of HCV-positive patients listed for transplant; however, without sustainable prices, this revolution is unlikely to happen., (© Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.)
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- 2015
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43. Hepatitis C virus recurrence after liver transplantation: a 10-year evaluation.
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Gitto S, Belli LS, Vukotic R, Lorenzini S, Airoldi A, Cicero AF, Vangeli M, Brodosi L, Panno AM, Di Donato R, Cescon M, Grazi GL, De Carlis L, Pinna AD, Bernardi M, and Andreone P
- Subjects
- Adult, Antiviral Agents adverse effects, Chi-Square Distribution, Drug Therapy, Combination, End Stage Liver Disease diagnosis, End Stage Liver Disease mortality, End Stage Liver Disease virology, Female, Hepacivirus drug effects, Hepacivirus growth & development, Hepatitis C complications, Hepatitis C diagnosis, Hepatitis C mortality, Humans, Italy, Kaplan-Meier Estimate, Logistic Models, Male, Middle Aged, Multivariate Analysis, Odds Ratio, Proportional Hazards Models, Recurrence, Retrospective Studies, Risk Factors, Time Factors, Treatment Outcome, Virus Activation drug effects, Antiviral Agents therapeutic use, End Stage Liver Disease surgery, Hepatitis C drug therapy, Liver Transplantation adverse effects, Liver Transplantation mortality
- Abstract
Aim: To evaluate the predictors of 10-year survival of patients with hepatitis C recurrence., Methods: Data from 358 patients transplanted between 1989 and 2010 in two Italian transplant centers and with evidence of hepatitis C recurrence were analyzed. A χ(2), Fisher's exact test and Kruskal Wallis' test were used for categorical and continuous variables, respectively. Survival analysis was performed at 10 years after transplant using the Kaplan-Meier method, and a log-rank test was used to compare groups. A P level less than 0.05 was considered significant for all tests. Multivariate analysis of the predictive role of different variables on 10-year survival was performed by a stepwise Cox logistic regression., Results: The ten-year survival of the entire population was 61.2%. Five groups of patients were identified according to the virological response or lack of a response to antiviral treatment and, among those who were not treated, according to the clinical status (mild hepatitis C recurrence, "too sick to be treated" and patients with comorbidities contraindicating the treatment). While the 10-year survival of treated and untreated patients was not different (59.1% vs 64.7%, P = 0.192), patients with a sustained virological response had a higher 10-year survival rate than both the "non-responders" (84.7% vs 39.8%, P < 0.0001) and too sick to be treated (84.7% vs 0%, P < 0.0001). Sustained virological responders had a survival rate comparable to patients untreated with mild recurrence (84.7% vs 89.3%). A sustained virological response and young donor age were independent predictors of 10-year survival., Conclusion: Sustained virological response significantly increased long-term survival. Awaiting the interferon-free regimen global availability, antiviral treatment might be questionable in selected subjects with mild hepatitis C recurrence.
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- 2015
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44. The Cost-Effectiveness Of Sofosbuvir And Ribavirin Treatment In Hcv-Infected Patients Listed For Liver Transplantation.
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Cortesi PA, Mantovani L, Ciaccio A, Rota M, Cesana G, Strazzabosco M, and Belli LS
- Published
- 2014
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45. A Comparison Between The Health-Related Quality Of Life Reported By The General Population And By Patients With Major Liver Diseases.
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Cortesi PA, Rota M, Scalone L, Cozzolino P, Cesana G, Mantovani L, Okolicsanyi S, Ciaccio A, Gemma M, Fagiuoli S, Valsecchi MG, Belli LS, and Strazzabosco M
- Published
- 2014
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46. Letter: Sorafenib hepatotoxicity may be enhanced during treatment of advanced hepatocellular carcinoma in HIV-infected patients.
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Mancuso A, Zavaglia C, Bai F, Puoti M, and Belli LS
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- Adult, Antiretroviral Therapy, Highly Active adverse effects, Drug Interactions, Humans, Middle Aged, Niacinamide adverse effects, Protein Kinase Inhibitors adverse effects, Sorafenib, Antineoplastic Agents adverse effects, Carcinoma, Hepatocellular drug therapy, Chemical and Drug Induced Liver Injury etiology, HIV Infections drug therapy, Liver Neoplasms drug therapy, Niacinamide analogs & derivatives, Phenylurea Compounds adverse effects
- Published
- 2013
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47. A caval homograft for Budd-Chiari syndrome due to inferior vena cava obstruction.
- Author
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Mancuso A, Martinelli L, De Carlis L, Rampoldi AG, Magenta G, Cannata A, and Belli LS
- Abstract
Transjugular intrahepatic portosystemic shunt (TIPS) is the standard treatment of Budd-Chiari syndrome (BCS) non responsive to medical therapy. However, patients with inferior vena cava (IVC) obstruction proximal to the atrium do not benefit from TIPS and a surgical approach is mandatory. We report the case of BCS due to intrapericardial IVC obstruction. We describe a novel surgical approach using a fresh caval homograft. An attempt to balloon dilatation of the IVC obstruction was complicated by right atrial disruption with tamponade and ventricular fibrillation. Lately, the patient successfully underwent a reconstruction of the cavo-atrial continuity by the interposition of a fresh caval homograft, a novel surgical approach never described before for BCS. Further follow-up revealed progressive reduction and resolution of ascites, and overall clinical improvement. IVC obstruction near to the atrium can be surgically approached with a new technique consisting in inferior vena cava resection and replacement with a caval homograft.
- Published
- 2013
- Full Text
- View/download PDF
48. Killer cell immunoglobulin-like receptor genotype and killer cell immunoglobulin-like receptor-human leukocyte antigen C ligand compatibility affect the severity of hepatitis C virus recurrence after liver transplantation.
- Author
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de Arias AE, Haworth SE, Belli LS, Burra P, Pinzello G, Vangeli M, Minola E, Guido M, Boccagni P, De Feo TM, Torelli R, Cardillo M, Scalamogna M, and Poli F
- Subjects
- Adult, Biopsy, Carcinoma, Hepatocellular immunology, Carcinoma, Hepatocellular virology, Disease Progression, Female, Gene Frequency, Genotype, Graft Rejection immunology, Graft Rejection virology, Graft Survival, Hepatitis C, Chronic immunology, Hepatitis C, Chronic surgery, Histocompatibility, Humans, Italy, Killer Cells, Natural virology, Ligands, Liver immunology, Liver pathology, Liver virology, Liver Cirrhosis immunology, Liver Cirrhosis virology, Liver Neoplasms immunology, Liver Neoplasms virology, Male, Middle Aged, Receptors, KIR immunology, Receptors, KIR2DL3 genetics, Recurrence, Retrospective Studies, Risk Assessment, Risk Factors, Severity of Illness Index, Time Factors, Transplantation, Homologous, Treatment Outcome, Carcinoma, Hepatocellular surgery, HLA-C Antigens immunology, Hepatitis C, Chronic complications, Killer Cells, Natural immunology, Liver Cirrhosis surgery, Liver Neoplasms surgery, Liver Transplantation, Receptors, KIR genetics
- Abstract
In 20% to 30% of infected individuals, hepatitis C virus (HCV) can cause cirrhosis and hepatocellular carcinoma, for which liver transplantation is the best treatment available. HCV re-infection is universal, and hepatitis disease recurrence occurs in most cases with a 30% probability of progression to graft cirrhosis at 5 years post-transplant. The immunological response to HCV involves natural killer (NK) cells and killer cell immunoglobulin-like receptors (KIRs), which specifically recognize human leukocyte antigen (HLA) class I antigens present on target cells. The effector functions of NK cells are influenced by inhibitory KIR interaction with self-HLA class I ligands, with HLA-C being the most predominant. This study examines the roles of KIR genotypes and their HLA ligands in both HCV disease recurrence and its progression. A total of 151 patients were included in the cohort, and their clinical details were recorded. Liver biopsies were used to define the absence/presence of recurrent hepatitis, the degree of fibrosis, and the progression to cirrhosis over a 10-year period. Mismatching of KIR-HLA-C ligands between donor-recipient pairs was associated with the recurrence of hepatitis (P = 0.008). The presence of KIR2DL3 in the recipient correlated with progression to liver fibrosis (P = 0.04). The mismatching of HLA-KIR ligands favored the progression of the recurrent hepatitis to fibrosis only in the presence of KIR2DL3 (P = 0.04). These preliminary results indicate that the KIR genotype and KIR-HLA-C ligand compatibility play roles in the recurrence and progression of hepatitis C disease in liver transplant recipients., (Copyright 2009 AASLD.)
- Published
- 2009
- Full Text
- View/download PDF
49. Liver transplantation for HCV cirrhosis: improved survival in recent years and increased severity of recurrent disease in female recipients: results of a long term retrospective study.
- Author
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Belli LS, Burroughs AK, Burra P, Alberti AB, Samonakis D, Cammà C, De Carlis L, Minola E, Quaglia A, Zavaglia C, Vangeli M, Patch D, Dhillon A, Cillo U, Guido M, Fagiuoli S, Giacomoni A, Slim OA, Airoldi A, Boninsegna S, Davidson BR, Rolles K, and Pinzello G
- Subjects
- Adult, Age Factors, Cohort Studies, Disease Progression, Female, Hepatitis C physiopathology, Humans, Kaplan-Meier Estimate, Liver Cirrhosis physiopathology, Longitudinal Studies, Male, Middle Aged, Recurrence, Retrospective Studies, Risk Factors, Severity of Illness Index, Sex Factors, Time Factors, Tissue Donors, Hepatitis C complications, Liver Cirrhosis surgery, Liver Cirrhosis virology, Liver Transplantation
- Abstract
In recent years, a worsening outcome of hepatitis C virus (HCV)-positive recipients and a faster progression of recurrent disease to overt cirrhosis has been reported. Our aims were to 1) assess patient survival and development of severe recurrent disease (Ishak fibrosis score > 3) in different transplant years; and 2) model the effects of pre- and post-liver transplantation (LT) variables on the severity of recurrent disease. A multicenter retrospective analysis was conducted on 502 consecutive HCV-positive transplant recipients between January 1990 and December 2002. Protocol liver biopsies were obtained at 1, 3, 5, 7, and 10 yr post-LT in almost 90% of the patients. All 502 patients were included in the overall survival analysis, while only the 354 patients with a follow-up longer than 1 yr were considered for the analysis of predictors of disease progression. The overall Kaplan-Meier survival rates were 78.7%, 66.3%, and 58.6%, at 12, 60, and 120 months, respectively, and a trend for a better patient survival over the years emerged from all 3 centers. The cumulative probability of developing HCV-related recurrent severe fibrosis (Ishak score 4-6) in the cohort of 354 patients who survived at least 1 yr remained unchanged over the years. Multivariate analysis indicated that older donors (P = 0.0001) and female gender of recipient (P = 0.02) were the 2 major risk factors for the development of severe recurrent disease, while the adoption of antilymphocytic preparations was associated with a less aggressive course (P = 0.03). Two of these prognostic factors, donor age and recipient gender, are easily available before LT and their combination showed an important synergy, such that a female recipient not only had a much higher probability of severe recurrent disease than a male recipient but her risk increased with the increasing age of the donor, reaching almost 100% when the age of the donor was 60 or older. In conclusion, a trend for a better patient survival was observed in more recent years but the cumulative probability of developing severe recurrent disease remained unchanged. The combination of a female recipient receiving an older graft emerged as a strong risk factor for a severe recurrence.
- Published
- 2007
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50. Biliary complications after living donor adult liver transplantation.
- Author
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Giacomoni A, Lauterio A, Slim AO, Vanzulli A, Calcagno A, Mangoni I, Belli LS, De Gasperi A, and De Carlis L
- Subjects
- Adult, Anastomosis, Surgical, Bile Ducts metabolism, Female, Hepatic Veins metabolism, Humans, Liver Transplantation methods, Living Donors, Male, Middle Aged, Time Factors, Biliary Tract injuries, Liver Transplantation adverse effects, Magnetic Resonance Imaging methods
- Abstract
The highest rate of complications characterizing the adult living donor liver transplantation (ALDLT) are due to biliary problems with a reported negative incidence of 22-64%. We performed 23 ALDLT grafting segments V-VIII without the middle hepatic vein from March 2001 to September 2005. Biliary anatomy was investigated using intraoperative cholangiography alone in the first five cases and magnetic resonance cholangiography in the remaining 18 cases. In 13 cases we found a single right biliary duct (56.5%) and in 10 we found multiple biliary ducts (43.7%). We performed single biliary anastomosis in 17 cases (73.91%) and double anastomosis in the remaining six (26%) cases. With a mean follow up of 644 days (8-1598 days), patient and graft survivals are 86.95% and 78.26%, respectively. The following biliary complications were observed: biliary leak from the cutting surface: three, anastomotic leak: two, late anastomotic strictures: five, early kinking of the choledochus: one. These 11 biliary complications (47.82%) occurred in eight patients (34.78%). Three of these patients developed two consecutive and different biliary complications. Biliary complications affected our series of ALDLT with a high percentage, but none of the grafts transplanted was lost because of biliary problems. Multiple biliary reconstructions are strongly related with a high risk of complication.
- Published
- 2006
- Full Text
- View/download PDF
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