Browsing by Subject "liver transplantation"
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Item Barriers to access in pediatric living‐donor liver transplantation(Wiley, 2019-09) Mogul, Douglas B.; Lee, Joy; Purnell, Tanjala S.; Massie, Allan B.; Ishaque, Tanveen; Segev, Dorry L.; Bridges, John F. P.; Medicine, School of MedicineChildren receiving a LDLT have superior post‐transplant outcomes, but this procedure is only used for 10% of transplant recipients. Better understanding about barriers toward LDLT and the sociodemographic characteristics that influence these underlying mechanisms would help to inform strategies to increase its use. We conducted an online, anonymous survey of parents/caregivers for children awaiting, or have received, a liver transplant regarding their knowledge and attitudes about LDLT. The survey was completed by 217 respondents. While 97% of respondents understood an individual could donate a portion of their liver, only 72% knew the steps in evaluation, and 69% understood the donor surgery was covered by the recipient's insurance. Individuals with public insurance were less likely than those with private insurance to know the steps for LDLT evaluation (44% vs 82%; P < 0.001). Respondents with public insurance were less likely to know someone that had been a living donor (44% vs 56%; P = 0.005) as were individuals without a college degree (64% vs 85%; P = 0.007). Nearly all respondents generally trusted their healthcare team. Among respondents, 82% believed they were well‐informed about LDLT but individuals with public insurance were significantly less likely to feel well‐informed (67% vs 87%; P = 0.03) and to understand how donor surgery might impact donor work/time off (44% vs 81%; P = 0.001). Substantial gaps exist in parental understanding about LDLT, including its evaluation, potential benefits, and complications. Greater emphasis on addressing these barriers, especially to individuals with fewer resources, will be helpful to expand the use of LDLT.Item Death and Liver Transplantation within Two Years of Onset of Drug-Induced Liver Injury(Wiley, 2017) Hayashi, Paul H.; Rockey, Don; Fontana, Robert J.; Tillmann, Hans L.; Kaplowitz, Neil; Barnhart, Huiman; Gu, Jiezhan; Chalasani, Naga; Reddy, K. Rajender; Sherker, Averell H.; Hoofnagle, Jay H.; Department of Medicine, IU School of MedicineDrug-induced liver injury (DILI) is an important cause of death and indication for liver transplantation (fatality). The role of DILI in these fatalities ispoorly characterized particularly when fatalities occur > 26 weeks after DILI onset. We analyzed patients in the U.S. Drug-Induced Liver Injury Network prospective study having a fatal outcome within 2 years of onset. Each case was reviewed by 8 Network investigators and categorized as DILI having a primary, contributory or no role in the fatality. We subcategorized primary role cases as acute, chronic, acute-on-chronic or acute cholestatic liver failure. For contributory and no role cases, we assigned a primary cause of death. Among 1089 patients, 107 (9.8%) fatalities occurred within 2 years. DILI had a primary role in 68 (64%), a contributory role in 15 (14%) and no role in 22 (21%); 2 had insufficient data. Among primary role cases, 74% had acute, 13% chronic, 7% acute-on-chronic and 6% acute cholestatic failure. For the 15 contributory role cases, common causes of death included sepsis, malignancy and severe cutaneous reactions with multi-organ failure. For the 22 no role cases, malignancies accounted for most fatalities. Higher bilirubin, coagulopathy, leukocytosis and thrombocytopenia were independently associated with DILI fatalities. nR Hy's Law had a higher positive predictive value for overall fatality (14% vs. 10%) and stronger independent association with DILI fatalities within 26 weeks compared to the original version of Hy's Law (HR: 6.2, CI 3.4 – 11.1 vs. 2.2, CI 1.3-3.7). DILI leads directly or indirectly to fatality in 7.6% of cases; 40% of these have non-acute liver failure courses. nR Hy's Law better identifies risk for death compared to the original Hy's Law.Item Eight‐Fold Increase in Dietary Supplement–Related Liver Failure Leading to Transplant Waitlisting Over the Last Quarter Century in the United States(Wiley, 2022-02) Ghabril, Marwan; Ma, Jiayi; Patidar, Kavish R.; Nephew, Lauren; Desai, Archita P.; Orman, Eric S.; Vuppalanchi, Raj; Kubal, Shekhar; Chalasani, Naga; Medicine, School of MedicineWe investigated the trends in listing and outcomes of drug-induced acute liver failure (DIALF) over the last quarter century in the United States using the United Network for Organ Sharing (UNOS) database. We examined waitlisted patients in the UNOS database between 1995 and 2020 with a diagnosis of DIALF and assessed trends in etiologies, demographic and clinical characteristics, and outcomes over 3 periods: 1995-2003, 2004-2012, and 2013-2020. Patients with DIALF and cirrhosis were classified as drug-induced acute-on-chronic liver failure. Implicated agents including acetaminophen (APAP) and herbal or dietary supplements (HDSs) were ascertained. There were 2146 individuals with DIALF during the study period. The observed demographic trends between the earliest and latest period included fewer pediatric patients (18.8% to 13.5%) but with an increasing number of males in non-APAP DIALF (31.8% to 41.4%) and increased racial diversity in APAP DIALF. Antimicrobials remained the most common non-APAP agents across all periods, but antiepileptics, propylthiouracil, and mushroom poisoning decreased, while HDSs markedly increased from 2.9% to 24.1% of all non-APAP DIALF patients. The overall 5-year post-liver transplantation (LT) patient survival improved significantly over the 3 periods (69.9% to 77.4% to 83.3%) and was evident for both APAP and non-APAP DIALF. Over the last quarter century, there has been an 8-fold increase in HDS-related liver failure necessitating waitlisting for liver transplantation in the United States. There are other important temporal trends during the study period, including improved survival following LT among both APAP and non-APAP DIALF patients.Item Expanding the Donor Pool with Utilization of Extended Criteria DCD Livers(AASLD, 2019) Mihaylov, Plamen; Mangus, Richard; Ekser, Burcin; Cabrales, Arianna; Timsina, Lava; Fridell, Jonathan; Lacerda, Marco; Ghabril, Marwan; Nephew, Lauren; Chalasani, Naga; Kubal, Chandrashekhar A.; Pediatrics, School of MedicineUtilization of donation after circulatory death donor (DCD) livers for transplantation has remained cautious in the U.S. The aim of this study was to demonstrate the expansion of DCD liver transplant (LT) program with the use of extended criteria DCD livers. After institutional review board approval, 135 consecutive DCD LTs were retrospectively studied. ECD DCD livers were defined as those with one of the followings: 1) donor age >50 years, 2) donor BMI >35 kg/m2, 3) donor functional warm ischemia time (fWIT) >30 minutes, and 4) donor liver macrosteatosis >30%. An optimization protocol was introduced in July 2011 to improve outcomes of DCD LT, which included thrombolytic donor flush, and efforts to minimize ischemic times. The impact of this protocol on outcomes was evaluated in terms of graft loss, ischemic cholangiopathy (IC) and change in DCD LT volume. Of 135 consecutive DCD LT, 62 were ECD DCDs. 24 ECD DCD LT were performed before (Era I) and 38 after the institution of optimization protocol (Era II), accounting for an increase in the use of ECD DCD livers from 39% to 52%. Overall outcomes of ECD DCD LT improved in Era II, with a significantly lower incidence of IC (5% vs. 17% in Era I; P = 0.03) and better 1‐year graft survival (93% vs. 75% in Era I, P = 0.07). Survival outcomes for ECD DCD LT in Era II were comparable to matched deceased donor (DBD) LT. With the expansion of the DCD donor pool, the number of DCD LT performed at our center gradually increased in Era II to account for > 20% of the center's LT volume. In conclusion, with the optimization of perioperative conditions, ECD DCD livers can be successfully transplanted to expand the donor pool for LT.Item Impact of Recipient Age in Combined Liver-Kidney Transplantation: Caution Is Needed for Patients ≥70 Years(Wolters Kluwer, 2020-06-01) Ekser, Burcin; Goggins, William C.; Fridell, Jonathan A.; Mihaylov, Plamen; Mangus, Richard S.; Lutz, Andrew J.; Soma, Daiki; Ghabril, Marwan S.; Lacerda, Marco A.; Powelson, John A.; Kubal, Chandrashekhar A.; Surgery, School of MedicineBackground. Elderly recipients (≥70 y) account for 2.6% of all liver transplants (LTs) in the United States and have similar outcomes as younger recipients. Although the rate of elderly recipients in combined liver-kidney transplant (CLKT) is similar, limited data are available on how elderly recipients perform after CLKT. Methods. We have previously shown excellent outcomes in CLKT using delayed kidney transplant (Indiana) Approach (mean kidney cold ischemia time = 53 ± 14 h). Between 2007 and 2018, 98 CLKTs were performed using the Indiana Approach at Indiana University (IU) and the data were retrospectively analyzed. Recipients were subgrouped based on their age: 18–45 (n = 16), 46–59 (n = 34), 60–69 (n = 40), and ≥70 years (n = 8). Results. Overall, more elderly patients received LT at IU (5.2%) when compared nationally (2.6%). The rate of elderly recipients in CLKT at IU was 8.2% (versus 2% Scientific Registry of Transplant Recipient). Recipient and donor characteristics were comparable between all age groups except recipient age and duration of dialysis. Patient survival at 1 and 3 years was similar among younger age groups, whereas patient survival was significantly lower in elderly recipients at 1 (60%) and 3 years (40%) (P = 0.0077). Control analyses (replicating Scientific Registry of Transplant Recipient’s survival stratification: 18–45, 46–64, ≥65 y) showed similar patient survival in all age groups. Conclusions. Although LT can be safely performed in elderly recipients, extreme caution is needed in CLKT due to the magnitude of operation.Item Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease(Elsevier, 2015-09) Charlton, Michael; Everson, Gregory T.; Flamm, Steven L.; Kumar, Princy; Landis, Charles; Brown, Robert S., Jr.; Fried, Michael W.; Terrault, Norah A.; O'Leary, Jacqueline G.; Vargas, Hugo E.; Kuo, Alexander; Schiff, Eugene; Sulkowski, Mark S.; Gilroy, Richard; Watt, Kymberly D.; Brown, Kimberly; Kwo, Paul; Pungpapong, Surakit; Korenblat, Kevin M.; Muir, Andrew J.; Teperman, Lewis; Fontana, Robert J.; Denning, Jill; Arterburn, Sarah; Dvory-Sobol, Hadas; Brandt-Sarif, Theo; Pang, Phillip S.; McHutchison, John G.; Reddy, K. Rajender; Afdhal, Nezam; Department of Medicine, IU School of MedicineBackground & Aims There are no effective and safe treatments for chronic hepatitis C virus (HCV) infection of patients who have advanced liver disease. Methods In this phase 2, open-label study, we assessed treatment with the NS5A inhibitor ledipasvir, the nucleotide polymerase inhibitor sofosbuvir, and ribavirin in patients infected with HCV genotypes 1 or 4. Cohort A enrolled patients with cirrhosis and moderate or severe hepatic impairment who had not undergone liver transplantation. Cohort B enrolled patients who had undergone liver transplantation: those without cirrhosis; those with cirrhosis and mild, moderate, or severe hepatic impairment; and those with fibrosing cholestatic hepatitis. Patients were assigned randomly (1:1) to receive 12 or 24 weeks of a fixed-dose combination tablet containing ledipasvir and sofosbuvir, once daily, plus ribavirin. The primary end point was sustained virologic response at 12 weeks after the end of treatment (SVR12). Results We enrolled 337 patients, 332 (99%) with HCV genotype 1 infection and 5 (1%) with HCV genotype 4 infection. In cohort A (nontransplant), SVR12 was achieved by 86%–89% of patients. In cohort B (transplant recipients), SVR12 was achieved by 96%–98% of patients without cirrhosis or with compensated cirrhosis, by 85%−88% of patients with moderate hepatic impairment, by 60%–75% of patients with severe hepatic impairment, and by all 6 patients with fibrosing cholestatic hepatitis. Response rates in the 12- and 24-week groups were similar. Thirteen patients (4%) discontinued the ledipasvir and sofosbuvir combination prematurely because of adverse events; 10 patients died, mainly from complications related to hepatic decompensation. Conclusion The combination of ledipasvir, sofosbuvir, and ribavirin for 12 weeks produced high rates of SVR12 in patients with advanced liver disease, including those with decompensated cirrhosis before and after liver transplantation.Item Liver Allocation to Non-Citizen Non-Residents: An Ethical Framework for a Last-In-Line Approach(Wiley, 2016-06) Hartsock, Jane A.; Ivy, Steven; Helft, Paul R.; Department of Medicine, IU School of MedicineThe incidence of non-U.S. citizen non-U.S. resident patients coming to the United States specifically for deceased donor liver transplantation raises compelling ethical questions that require careful consideration. The inclusion of these often financially and/or socially privileged patients in the pool of potential candidates for an absolutely scarce and life-saving liver transplant may exacerbate disparities already existing in deceased donor liver allocation. In addition, their inclusion on organ transplant waiting lists conflicts with recognized ethical principles of justice and reciprocity. Moreover, preliminary data suggest that public awareness of this practice could discourage organ donation, thereby worsening an already profound supply–demand gulf. Finally, U.S. organ allocation policies and statutes are out of step with recently promulgated international transplant guidelines, which prioritize self-sufficiency of organ programs. This article analyzes each of these ethical conflicts within the context of deceased donor liver transplantation and recommends policy changes that align the United States with international practices that discourage this scenario.Item Neighborhood poverty is associated with failure to be waitlisted and death during liver transplantation evaluation(Wiley, 2022-09) Mohamed, Kawthar A.; Ghabril, Marwan; Desai, Archita; Orman, Eric; Patidar, Kavish R.; Holden, John; Rawl, Susan; Chalasani, Naga; Kubal, Chandra Shekhar; Nephew, Lauren D.; Medicine, School of MedicineLiver transplantation (LT) is the final step in a complex care cascade. Little is known about how race, gender, rural versus urban residence, or neighborhood socioeconomic indicators impact a patient's likelihood of LT waitlisting or risk of death during LT evaluation. We performed a retrospective cohort study of adults referred for LT to the Indiana University Academic Medical Center from 2011 to 2018. Neighborhood socioeconomic status indicators were obtained by linking patients' addresses to their census tract defined in the 2017 American Community Survey. Descriptive statistics were used to describe completion of steps in the LT evaluation cascade. Multivariable analyses were performed to assess the factors associated with waitlisting and death during LT evaluation. There were 3454 patients referred for LT during the study period; 25.3% of those referred were waitlisted for LT. There was no difference seen in the proportion of patients from vulnerable populations who progressed to the steps of financial approval or evaluation start. There were differences in waitlisting by insurance type (22.6% of Medicaid vs. 34.3% of those who were privately insured; p < 0.01) and neighborhood poverty (quartile 1 29.6% vs. quartile 4 20.4%; p < 0.01). On multivariable analysis, neighborhood poverty was independently associated with waitlisting (odds ratio 0.56, 95% confidence interval [CI] 0.38–0.82) and death during LT evaluation (hazard ratio 1.49, 95% CI 1.09–2.09). Patients from high-poverty neighborhoods are at risk of failing to be waitlisted and death during LT evaluation.Item Optimal Timing of Administration of Direct-Acting Antivirals for Patients with Hepatitis C-Associated Hepatocellular Carcinoma Undergoing Liver Transplantation(Wolters Kluwer, 2021-10) Turgeon, Michael K.; Shah, Shimul A.; Delman, Aaron M.; Tran, Benjamin V.; Agopian, Vatche G.; Wedd, Joel P.; Magliocca, Joseph F.; Kim, Ahyoung; Cameron, Andrew; Olyaei, Ali; Orloff, Susan L.; Anderson, Matthew P.; Kubal, Chandrashekhar A.; Cannon, Robert M.; Locke, Jayme E.; Simpson, Mary A.; Akoad, Mohamed E.; Wongjirad, Chelsey P.; Emamaullee, Juliet; Moro, Amika; Aucejo, Federico; Feizpour, Cyrus A.; Vagefi, Parsia A.; Nguyen, Mindie H.; Esquivel, Carlos O.; Dhanireddy, Kiran; Subramanian, Vijay; Chavarriaga, Alejandro; Kazimi, Marwan M.; Anderson, Maia S.; Sonnenday, Christopher J.; Kim, Steven C.; Foley, David P.; Abdouljoud, Marwan; Salgia, Reena J.; Moris, Dimitrios; Sudan, Debra L.; Ganesh, Swaytha R.; Humar, Abhinav; Doyle, Majella; Chapman, William C.; Maithel, Shishir K.; Surgery, School of MedicineObjective: To investigate the optimal timing of direct acting antiviral (DAA) administration in patients with hepatitis C-associated hepatocellular carcinoma (HCC) undergoing liver transplantation (LT). Summary of Background Data: In patients with hepatitis C (HCV) associated HCC undergoing LT, the optimal timing of direct-acting antivirals (DAA) administration to achieve sustained virologic response (SVR) and improved oncologic outcomes remains a topic of much debate. Methods: The United States HCC LT Consortium (2015–2019) was reviewed for patients with primary HCV-associated HCC who underwent LT and received DAA therapy at 20 institutions. Primary outcomes were SVR and HCC recurrence-free survival (RFS). Results: Of 857 patients, 725 were within Milan criteria. SVR was associated with improved 5-year RFS (92% vs 77%, P < 0.01). Patients who received DAAs pre-LT, 0–3 months post-LT, and ≥3 months post-LT had SVR rates of 91%, 92%, and 82%, and 5-year RFS of 93%, 94%, and 87%, respectively. Among 427 HCV treatment-naïve patients (no previous interferon therapy), patients who achieved SVR with DAAs had improved 5-year RFS (93% vs 76%, P < 0.01). Patients who received DAAs pre-LT, 0–3 months post-LT, and ≥3 months post-LT had SVR rates of 91%, 93%, and 78% (P < 0.01) and 5-year RFS of 93%, 100%, and 83% (P = 0.01). Conclusions: The optimal timing of DAA therapy appears to be 0 to 3 months after LT for HCV-associated HCC, given increased rates of SVR and improved RFS. Delayed administration after transplant should be avoided. A prospective randomized controlled trial is warranted to validate these results.Item Outcome of COVID-19 in Patients with Autoimmune Hepatitis: an International Multi-Centre Study(Wiley, 2021) Efe, Cumali; Dhanasekaran, Renumathy; Lammert, Craig; Ebi, Berat; Higuera‐de la Tijera, Fatima; Aloman, Costica; Rıza Calışkan, Ali; Peralta, Mirta; Gerussi, Alessio; Massoumi, Hatef; Catana, Andreea M.; Torgutalp, Murat; Purnak, Tugrul; Rigamonti, Cristina; Gomez Aldana, Andres Jose; Khakoo, Nidah; Kacmaz, Hüseyin; Nazal, Leyla; Frager, Shalom; Demir, Nurhan; Irak, Kader; Ellik, Zeynep Melekoğlu; Balaban, Yasemin; Atay, Kadri; Eren, Fatih; Cristoferi, Laura; Batıbay, Ersin; Urzua, Álvaro; Snijders, Romee; Kıyıcı, Murat; Akyıldız, Murat; Ekin, Nazım; Carr, Rotonya M; Harputoğlu, Murat; Hatemi, Ibrahim; Mendizabal, Manuel; Silva, Marcelo; Idilman, Ramazan; Silveira, Marina; Drenth, Joost P.H.; Assis, David N.; Björnsson, Einar; Boyer, James L.; Invernizzi, Pietro; Levy, Chyntia; Schiano, Thomas D.; Ridruejo, Ezequiel; Wahlin, Staffan; Medicine, School of MedicineBackground Data regarding outcome of Coronavirus disease 2019 (COVID‐19) in patients with autoimmune hepatitis (AIH) are lacking. Patients and methods We performed a retrospective study on AIH patients with COVID‐19 from 34 centres in Europe and the Americas. We analyzed factors associated with severe COVID‐19 outcomes defined as the need for mechanical ventilation, intensive care admission, and/or death. The outcomes of patients with AIH were compared to a propensity‐score matched cohort of non‐AIH patients with chronic liver diseases (CLD) and COVID‐19. The frequency and clinical significance of new‐onset liver injury (alanine aminotransferase>2xupper limit of normal) during COVID‐19 was also evaluated. Results We included 110 AIH patients (80%,female) with a median age of 49 (range:18–85) years at COVID‐19 diagnosis. New‐onset liver injury was observed in 37.1% (33/89) of the patients. Use of antivirals was associated with liver injury (p=0.041; odds ratio (OR) 3.36[1.05‐10.78]) while continued immunosuppression during COVID‐19 was associated with a lower rate of liver injury (p=0.009; OR 0.26[0.09‐0.71]). The rates of severe COVID‐19 (15.5% vs 20.2% p=0.231) and all‐cause mortality (10% vs 11.5%; p=0.852) were not different between AIH and non‐AIH CLD. Cirrhosis was an independent predictor of severe COVID‐19 in patients with AIH (p<0.001; OR 17.46[4.22‐72.13]). Continuation of immunosuppression or presence of liver injury during COVID‐19 was not associated with severe COVID‐19. Conclusions This international, multi‐center study reveals that patients with AIH were not at risk for worse outcomes with COVID‐19 than other causes of CLD. Cirrhosis was the strongest predictor for severe COVID‐19 in AIH patients. Maintenance of immunosuppression during COVID‐19 was not associated with increased risk for severe COVID‐19, but did lower the risk for new‐onset liver injury during COVID‐19.