Search

Objective: To assess the impact of normothermic machine perfusion (NMP) on patients, medical teams, and costs by gathering global insights and exploring current limitations., Background: NMP for ex situ liver graft perfusion is gaining increasing attention for its capability to extend graft preservation. It has the potential to transform liver transplantation (LT) from an urgent to a purely elective procedure, which could revolutionize LT logistics, reduce burden on patients and health care providers, and decrease costs., Methods: A 31-item survey was sent to international transplant directors to gather their NMP experiences and vision. In addition, we performed a systematic review on cost-analysis in LT and assessed studies on cost-benefit in converting urgent-to-elective procedures. We compared the costs of available NMPs and conducted a sensitivity analysis of NMP's cost benefits., Results: Of 120 transplant programs contacted, 64 (53%) responded, spanning North America (31%), Europe (42%), Asia (22%), and South America (5%). Of the total, 60% had adopted NMP, with larger centers (>100 transplants/year) in North America and Europe more likely to use it. The main NMP systems were OrganOx-metra (39%), XVIVO (36%), and TransMedics-OCS (15%). Despite NMP adoption, 41% of centers still perform >50% of LTs at nights/weekends. Centers recognized NMP's benefits, including improved work satisfaction and patient outcomes, but faced challenges like high costs and machine complexity. 16% would invest $100,000 to 500'000, 33% would invest $50,000 to 100'000, 38% would invest $10,000 to 50'000, and 14% would invest <$10,000 in NMP. These results were strengthened by a cost analysis for NMP in emergency-to-elective LT transition. Accordingly, while liver perfusions with disposables up to $10,000 resulted in overall positive net balances, this effect was lost when disposables' cost amounted to >$40,000/organ., Conclusions: The adoption of NMP is hindered by high costs and operational complexity. Making LT elective through NMP could reduce costs and improve outcomes, but overcoming barriers requires national reimbursements and simplified, automated NMP systems for multiday preservation., Competing Interests: M.P., F.H., W.H., M.W.T., P.D. and P.A.C. are part of the Liver4Life project, which involves the development of an ex situ normothermic perfusion machine. The remaining authors report no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Psychiatric disorders after liver transplantation (LT) are associated with worse patient and graft outcomes, which may be amplified by inadequate treatment. We aimed to characterize the burden of psychiatric disorders, treatment patterns, and associated financial burden among liver transplantation recipients (LTRs). IQVIA PharMetrics (R) Plus for Academics-a large health plan claims database representative of the commercially insured US population-was used to identify psychiatric diagnoses among adult LTRs and assess treatment. Multivariable logistic regression analysis identified factors associated with post-LT psychiatric diagnoses and receipt of pharmacotherapy. Patient financial liability was estimated using adjudicated medical/pharmacy claims for LTRs with and without psychiatric diagnoses. Post-LT psychiatric diagnoses were identified in 395 (29.5%) of 1338 LTRs, of which 106 (26.8%) were incident cases. Treatment varied, with 67.3% receiving pharmacotherapy, 32.1% psychotherapy, 21.0% combination therapy, and 21.5% no treatment. Among 340 LTRs on psychotropic medications before transplant, 24% did not continue them post-LT. Post-LT psychiatric diagnoses were independently associated with female sex, alcohol-associated liver disease (ALD), prolonged LT hospitalization (>2 wk), and pre-LT psychiatric diagnosis. Incident psychiatric diagnoses were associated with female sex, ALD, and prolonged LT hospitalization. Patients with a post-LT psychiatric diagnosis had higher rates of hospitalization (89.6% vs. 81.5%, p <0.001) and financial liability (median $5.5K vs. $4.6K USD, p =0.006). Having a psychiatric diagnosis post-LT was independently associated with experiencing high financial liability >$5K. Over 1 in 4 LTRs had a psychiatric diagnosis in a large national cohort, yet nearly a quarter received no treatment. LTRs with psychiatric diagnoses experienced increased health care utilization and higher financial liability. Sociodemographic and clinical risk factors could inform high-risk subgroups who may benefit from screening and mitigation strategies., (Copyright © 2024 American Association for the Study of Liver Diseases.)

Background: Open offers (OOs) in liver transplantation (LT) result from bypassing the traditional allocation system. Little is known about the trends of OOs or the differences in donor/recipient characteristics compared to traditionally placed organs. We aim to quantify modern practices regarding OOs and understand NMP's impact, focusing on social determinants of health (SDH), cost, and graft-associated risk., Methods: LTs from 1/1/2018 to 12/31/2023 at a single center were included. NMP was implemented on 10/1/2022. The CDC (centers for disease control)-validated social vulnerability index (SVI) and donor risk index (DRI) were calculated. Comprehensive complications index (CCI), Clavien-Dindo grades, patient and graft survival, and costs of transplantation were included., Results: 1162 LTs were performed; 193 (16.8%) from OOs. OOs were more common in the post-NMP era (26.5% vs. 13.3%, p < 0.001). Pre-NMP, patients receiving OOs had longer waitlist times (118 vs. 69 days, p < 0.001), lower MELDs (17 vs. 25 points, p < 0.001), and riskier grafts (DRI = 1.8 vs. 1.6, p = 0.004) compared to standard offers. Post-NMP, recipients receiving OOs demonstrated no difference in waitlist time (27 vs. 20 days, p = 0.21) or graft risk (DRI = 2.03 vs. 2.23, p = 0.17). OO recipient MELD remained lower (16 vs. 22, p < 0.001). OO recipients were more socially vulnerable (SVI), pre-NMP (0.41 vs. 0.36, p = 0.004), but less vulnerable after NMP (0.23 vs. 0.36, p = 0.019). Despite increased graft risk, pre-NMP OO-LTs were less expensive in the 90-day global period ($154 939 vs. $178 970, p = 0.002) and the 180-days pre-/post-LT ($208 807 vs. $228 091, p = 0.021). Cost trends remained similar with NMP., Conclusion: OOs are increasingly utilized and may be appealing due to demonstrated cost reductions even with NMP. Although most OO-related metrics in our center remain similar before and after machine perfusion, programs should take caution that increasing use does not worsen organ access for socially vulnerable populations., (© 2024 The Author(s). Clinical Transplantation published by Wiley Periodicals LLC.)

Background: Successful early extubation (EE) after liver transplant (LT) has been shown to reduce intensive care unit (ICU) and hospital length of stay and infectious, vascular, and sedation-related complications in adults. EE may not always be feasible in children, and many may require prolonged mechanical ventilation. Limited data exists regarding the candidacy of EE, risk factors, consequences, and hospital costs of delayed extubation (DE) in pediatric LT., Methods: We conducted a retrospective review to investigate predictive factors and associated costs of EE and DE in infants and children after orthotopic LT at our institution between 2011 and 2021., Results: Of 338 LT (median age 39 months, 54% females), 246 (73%) had EE (within 24 h of LT), while 27% had DE. Age < 1 year (p = 0.0019), diagnosis of biliary atresia (0.02), abnormal pre-LT echocardiogram (0.02), and patients with ongoing hospital admission before LT (0.0001) were independently associated with DE. Hospital costs were significantly (∼3-fold) higher (p < 0.0001) in the DE group. In addition, factors associated with increased total hospital costs were age < 1 year and hospitalization before LT., Conclusion: EE post-LT is feasible and merits a trial. The prevalence of DE though modest is associated with increased resource utilization and hospital costs. Children who can be extubated early and those at risk for DE can be identified pre-operatively for optimal planning and allocation of resources., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

After 2 decades of limited growth, living donor liver transplant (LDLT) has been increasingly accepted as a promising solution to the growing organ shortage in the US. With experience, LDLT offers superior graft and patient survival with low rates of rejection. However, not all waitlisted patients have equal access to LDLT, with financial toxicity representing a substantial barrier. Potential living liver donors face indirect, direct, and opportunity costs associated with donation as well as insurance-based discrimination and variable employer leave policies. There are multiple potential national, local, and patient-centered solutions to address some of the cost-related issues associated with living LDLT. These include standardization of employer leave policies, creation of federal and state-led tax relief programs, optimization of National Living Donor Assistance Center use, engagement of independent living donor advocates, creation of financial toolkits, and encouragement of recipient or donor-led fundraising. In this piece, members of the North American Living Liver Donation Group, a consortium of 37 LDLT programs, explore these financial challenges and discuss solutions to achieve financial neutrality, where individuals can donate free from financial constraints or gains. As a community, it is imperative that we confront factors driving financial toxicity to improve equity and access to LDLT., Competing Interests: Declaration of competing interest The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation., (Copyright © 2024 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved.)

Biliary atresia is a progressive cholangiopathy in neonates, which often results in liver failure. In high-income countries, initial treatment requires prompt diagnosis followed by Kasai portoenterostomy. For those with a late diagnosis, or those in whom Kasai portoenterostomy fails, liver transplantation is the only lifesaving treatment. Unfortunately, in low- and middle-income countries, timely diagnosis is a challenge and liver transplantation is rarely accessible. Here, we discuss the ethical dilemmas surrounding treatment of babies with biliary atresia in Uganda. Issues that require careful consideration include: risk of catastrophic health expenditure to families, ethical dilemmas of transplant tourism, medical risks of maintaining the transplant in a low-resourced health system, and difficult decisions encountered by the surgeon caring for these patients. Four distinct models of the patient-physician relationship are applied to biliary atresia in Uganda. These models describe differences in patient and physician roles, and patient values and autonomy. Solid organ transplantation is a rapidly evolving segment of healthcare in Uganda and ongoing policy advancements may shift ethical considerations in the future., (© 2024 International Society of Surgery/Société Internationale de Chirurgie (ISS/SIC).)

Deceased donor organs for transplantation are costly. Expenses include donor assessment, pre-operative care of acceptable donors, surgical organ recovery, preservation and transport, and other costs. US Organ Procurement Organizations (OPOs) serve defined geographic areas in which each OPO has exclusive organ recovery responsibilities including detailed reporting of costs. We sought to determine the costs of procuring deceased donor livers by examining reported organ acquisition costs from OPO cost reports. Using 6 years of US OPO cost report data for each OPO (2013-2018), we determined the average cost of recovering a viable (i.e., transplanted) liver for each of the 51 independent US OPOs. We examined predictors of these costs including the number of livers procured, the percent of nonviable livers, direct procurement costs, coordinator salaries, professional education, and local cost of living. A cost curve estimated the relationship between the cost of livers and the number of locally procured livers. The average cost of procured livers by individual OPO-year varied widely from $11 393 to $65 556 (average $31 659) over the six study years. An increase in the overall number of procured livers was associated with lower direct costs, administrative, and procurement overhead costs, but this association differed for imported livers. Cost per local liver decreased linearly for each additional liver, while importing more livers was only cost saving until 200 livers, with imported livers costing more ($39K vs. $31.7K). The largest predictor of variation in cost was the aggregate of direct costs (e.g., hospital costs) to recover the organ (57%). Cost increases were 2.5% per year (+$766/year). This information may be valuable in determining how OPOs might improve service to transplant centers and the patients they serve., (© 2024 The Author(s). Clinical Transplantation published by Wiley Periodicals LLC.)

Introduction: Frailty, a measure of physiological aging and reserve, has been validated as a prognostic indicator of mortality in patients with cirrhosis. However, large-scale analyses of the independent association of frailty with clinical and financial outcomes following liver transplantation (LT) are lacking., Methods: Adults (≥18 years) undergoing LT were identified in the 2016-2020 National Readmissions Database. Frailty was defined using the binary Johns Hopkins Adjusted Clinical Groups frailty indicator. Multivariable linear and logistic regression models were developed to evaluate the independent association of frailty with in-hospital mortality, perioperative complications, and costs., Results: Of an estimated 34 442 patients undergoing LT, 8265 (24%) were frail. After adjustment, frailty was associated with greater odds of mortality (adjusted odds ratio [AOR] 1.80; 95% Confidence Interval [CI]: 1.49-1.18), postoperative length of stay (β + 11 days; 95% CI: +10, +12), and hospitalization costs (+$86 880; 95% CI: +75 660, +98 100), as well as a two-fold increase in relative risk of nonhome discharge (AOR 2.17, 95% CI: 1.90-2.49)., Conclusions: Frailty is associated with an increased risk of in-hospital mortality, complications, and resource utilization among LT recipients. As the proportion of frail LT patients continues to rise, our findings underscore the need for novel risk-stratification and individualized care protocols for such vulnerable patients., (© 2024 The Author(s). Clinical Transplantation published by Wiley Periodicals LLC.)

Liver transplantation (LT) is lifesaving for patients with cirrhosis; however, the resultant financial burden to patients has not been well characterized. We aimed to provide a nationally representative portrayal of patient financial burden after LT. Adult recipients of LT from 2006 to 2021 were identified using IQVIA PharMetrics® Plus for Academics-a large nationally representative claims database of commercially insured Americans. Patient financial liability (ie, what patients owe) was estimated using the difference between allowed and paid costs for adjudicated medical/pharmacy claims. Descriptive statistics were provided stratified by the financial liability group within 1 year after LT. Multivariable logistic regression modeling identified factors associated with high/extreme liability adjusting for covariates. Potential indirect costs of post-LT care were estimated based on hourly wages lost for care. Among 1412 recipients of LT, financial liability was heterogeneous-~3% had no liability and 21% had extreme liability > $10K for 1-year post-LT care; most (69%) paid between $1 and 10K, with 48% having liability >$5K. Factors associated with >$5K liability included older age, insurance/enrollment type, US region, history of HCC, and simultaneous liver-kidney transplant (for liability >$10K). Medication costs comprised ~30% of outpatient financial liability. Potential indirect costs from wages lost were $2,201-$6,073 per person, depending on an hourly wage. In a large national cohort of commercially insured recipients of LT, financial liability was highly variable across sociodemographic and clinical characteristics; nearly 1 out of 2 recipients of LT owed >$5K for 1 year of post-LT care. Transplant programs should help patients anticipate potential costs and identify vulnerable populations who would benefit from enhanced financial counseling., (Copyright © 2023 American Association for the Study of Liver Diseases.)

The financial impact of liver transplantation has been underexplored. We aimed to identify associations between high financial burden (≥10% annual income spent on out-of-pocket medical costs) and work productivity, financial distress (coping behaviors in response to the financial burden), and financial toxicity (health-related quality of life, HRQOL) among adult recipients of liver transplant. Between June 2021 and May 2022, we surveyed 207 adult recipients of liver transplant across 5 US transplant centers. Financial burden and distress were measured by 25 items adapted from national surveys of cancer survivors. Participants also completed the Work Productivity and Activity Impairment and EQ-5D-5L HRQOL questionnaires. In total, 23% of recipients reported high financial burden which was significantly associated with higher daily activity impairment (32.9% vs. 23.3%, p =0.048). In adjusted analyses, the high financial burden was significantly and independently associated with delayed or foregone medical care (adjusted odds ratio, 3.95; 95% CI, 1.85-8.42) and being unable to afford basic necessities (adjusted odds ratio, 5.12; 95% CI: 1.61-16.37). Recipients experiencing high financial burden had significantly lower self-reported HRQOL as measured by the EQ-5D-5L compared to recipients with low financial burden (67.8 vs. 76.1, p =0.008) and an age-matched and sex-matched US general population (67.8 vs. 79.1, p <0.001). In this multicenter cohort study, nearly 1 in 4 adult recipients of liver transplant experienced a high financial burden, which was significantly associated with delayed or foregone medical care and lower self-reported HRQOL. These findings underscore the need to evaluate and address the financial burden in this population before and after transplantation., (Copyright © 2024 American Association for the Study of Liver Diseases.)

Objective: Assess cost and complication outcomes after liver transplantation (LT) using normothermic machine perfusion (NMP)., Background: End-ischemic NMP is often used to aid logistics, yet its impact on outcomes after LT remains unclear, as does its true impact on costs associated with transplantation., Methods: Deceased donor liver recipients at 2 centers (January 1, 2019, to June 30, 2023) were included. Retransplants, splits, and combined grafts were excluded. End-ischemic NMP (OrganOx-Metra) was implemented in October 2022 for extended-criteria donation after brain death (DBDs), all donations after circulatory deaths (DCDs), and logistics. NMP cases were matched 1:2 with static cold storage controls (SCS) using the Balance-of-Risk [donation after brain death (DBD)-grafts] and UK-DCD Score (DCD-grafts)., Results: Overall, 803 transplantations were included, 174 (21.7%) receiving NMP. Matching was achieved between 118 NMP-DBDs with 236 SCS; and 37 NMP-DCD with 74 corresponding SCS. For both graft types, median inpatient comprehensive complications index values were comparable between groups. DCD-NMP grafts experienced reduced cumulative 90-day comprehensive complications index (27.6 vs 41.9, P =0.028). NMP also reduced the need for early relaparotomy and renal replacement therapy, with subsequently less frequent major complications (Clavien-Dindo ≥IVa). This effect was more pronounced in DCD transplants. NMP had no protective effect on early biliary complications. Organ acquisition/preservation costs were higher with NMP, yet NMP-treated grafts had lower 90-day pretransplant costs in the context of shorter waiting list times. Overall costs were comparable for both cohorts., Conclusions: This is the first risk-adjusted outcome and cost analysis comparing NMP and SCS. In addition to logistical benefits, NMP was associated with a reduction in relaparotomy and bleeding in DBD grafts, and overall complications and post-LT renal replacement for DCDs. While organ acquisition/preservation was more costly with NMP, overall 90-day health care costs-per-transplantation were comparable., Competing Interests: The authors report no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

BACKGROUND. Differences in survival and morbidity among treatment options (ablation, surgical resection, and transplant) for early-stage hepatocellular carcinoma (HCC) have been well studied. Additional understanding of the costs of such care would help to identify drivers of high costs and potential barriers to care delivery. OBJECTIVE. The purpose of this article was to quantify total and patient out-of-pocket costs for ablation, surgical resection, and transplant in the management of early-stage HCC and to identify factors predictive of these costs. METHODS. This retrospective U.S. population-based study used the SEER-Medicare linked dataset to identify a sample of 1067 Medicare beneficiaries (mean age, 73 years; 674 men, 393 women) diagnosed with early-stage HCC (size ≤ 5 cm) treated with ablation ( n = 623), resection ( n = 201), or transplant ( n = 243) between January 2009 and December 2016. Total costs and patient out-of-pocket costs for the index procedure as well as for any care within 30 and 90 days after the procedure were identified and stratified by treatment modality. Additional comparisons were performed among propensity score-matched subgroups of patients treated by ablation or resection (each n = 172). Multivariable linear regression models were used to identify factors predictive of total costs and out-of-pocket costs for index procedures as well as for 30- and 90-day post-procedure periods. RESULTS. For ablation, resection, and transplant, median index-procedure total cost was US$6689, US$25,614, and US$66,034; index-procedure out-of-pocket cost was US$1235, US$1650, and US$1317; 30-day total cost was US$9456, US$29,754, and US$69,856; 30-day out-of-pocket cost was US$1646, US$2208, and US$3198; 90-day total cost was US$14,572, US$34,984, and US$88,103; and 90-day out-of-pocket cost was US$2138, US$2462, and US$3876, respectively (all p < .001). In propensity score-matched subgroups, ablation and resection had median index-procedure, 30-day, and 90-day total costs of US$6690 and US$25,716, US$9995 and US$30,365, and US$15,851 and US$34,455, respectively. In multivariable analysis adjusting for socioeconomic factors, comorbidities, and liver-disease prognostic indicators, surgical treatment (resection or transplant) was predictive of significantly greater costs compared with ablation at all time points. CONCLUSION. Total and out-of-pocket costs for index procedures as well as for 30-day and 90-day postprocedure periods were lowest for ablation, followed by resection and then transplant. CLINICAL IMPACT. This comprehensive cost analysis could help inform future cost-effectiveness analyses.

Understanding the economics of pediatric liver transplantation (LT) is central to high-value care initiatives. We examined cost and resource utilization in pediatric LT nationally to identify drivers of cost and hospital factors associated with greater total cost of care. We reviewed 3295 children (<21 y) receiving an LT from 2010 to 2020 in the Pediatric Health Information System to study cost, both per LT and service line, and associated mortality, complications, and resource utilization. To facilitate comparisons, patients were stratified into high-cost, intermediate-cost, or low-cost tertiles based on LT cost. The median cost per LT was $150,836 [IQR $104,481-$250,129], with marked variance in cost within and between hospital tertiles. High-cost hospitals (HCHs) cared for more patients with the highest severity of illness and mortality risk levels (67% and 29%, respectively), compared to intermediate-cost (60%, 21%; p <0.001) and low-cost (51%, 16%; p <0.001) hospitals. Patients at HCHs experienced a higher prevalence of mechanical ventilation, total parental nutrition use, renal comorbidities, and surgical complications than other tertiles. Clinical (27.5%), laboratory (15.1%), and pharmacy (11.9%) service lines contributed most to the total cost. Renal comorbidities ($69,563) and total parental nutrition use ($33,192) were large, independent contributors to total cost, irrespective of the cost tertile ( p <0.001). There exists a significant variation in pediatric LT cost, with HCHs caring for more patients with higher illness acuity and resource needs. Studies are needed to examine drivers of cost and associated outcomes more granularly, with the goal of defining value and standardizing care. Such efforts may uniquely benefit the sicker patients requiring the strategic resources located within HCHs to achieve the best outcomes., (Copyright © 2024 American Association for the Study of Liver Diseases.)

Importance: A new liver allocation policy was implemented by United Network for Organ Sharing (UNOS) in February 2020 with the stated intent of improving access to liver transplant (LT). There are growing concerns nationally regarding the implications this new system may have on LT costs, as well as access to a chance for LT, which have not been captured at a multicenter level., Objective: To characterize LT volume and cost changes across the US and within specific center groups and demographics after the policy implementation., Design, Setting, and Participants: This cross-sectional study collected and reviewed LT volume from multiple centers across the US and cost data with attention to 8 specific center demographics. Two separate 12-month eras were compared, before and after the new UNOS allocation policy: March 4, 2019, to March 4, 2020, and March 5, 2020, to March 5, 2021. Data analysis was performed from May to December 2022., Main Outcomes and Measures: Center volume, changes in cost., Results: A total of 22 of 68 centers responded comparing 1948 LTs before the policy change and 1837 LTs postpolicy, resulting in a 6% volume decrease. Transplants using local donations after brain death decreased 54% (P < .001) while imported donations after brain death increased 133% (P = .003). Imported fly-outs and dry runs increased 163% (median, 19; range, 1-75, vs 50, range, 2-91; P = .009) and 33% (median, 3; range, 0-16, vs 7, range, 0-24; P = .02). Overall hospital costs increased 10.9% to a total of $46 360 176 (P = .94) for participating centers. There was a 77% fly-out cost increase postpolicy ($10 600 234; P = .03). On subanalysis, centers with decreased LT volume postpolicy observed higher overall hospital costs ($41 720 365; P = .048), and specifically, a 122% cost increase for liver imports ($6 508 480; P = .002). Transplant centers from low-income states showed a significant increase in hospital (12%) and import (94%) costs. Centers serving populations with larger proportions of racial and ethnic minority candidates and specifically Black candidates significantly increased costs by more than 90% for imported livers, fly-outs, and dry runs despite lower LT volume. Similarly, costs increased significantly (>100%) for fly-outs and dry runs in centers from worse-performing health systems., Conclusions and Relevance: Based on this large multicenter effort and contrary to current assumptions, the new liver distribution system appears to place a disproportionate burden on populations of the current LT community who already experience disparities in health care. The continuous allocation policies being promoted by UNOS could make the situation even worse.

Donation after circulatory death (DCD) donors now represent over 30% of the deceased donor pool in the United States. Compared to donation after brain death, DCD is less likely to result in transplantation. For each potential donor whose organs cannot be utilized for transplantation (ie, dry run), fees are associated with the attempted donation, which add to the overall costs of organ acquisition. To better characterize the true costs of DCD liver acquisition, we performed a cost comparison of the fees associated with organ acquisition for DCD versus donation after brain death at a single transplant institute that comprises 2 liver transplant centers. Cost, recipient, and transportation data for all cases, including fees associated with liver acquisition from July 1, 2019, to October 31, 2021, were collected. We found that the total cost of DCD liver acquisition per liver transplant was $15,029 more than that for donation after brain death donation, with 18% of the costs of the DCD transplant attributed to dry runs. Overall, the costs associated with DCD transplantation accounted for 34.5% of the total organ acquisition costs; however, DCD transplantation accounted for 30.3% of the transplantation volume. Because the expansion of DCD is essential to increasing the availability of liver grafts for transplantation, strategies need to be implemented to decrease the costs associated with dry runs, including using local recovery, transferring donors to hospitals close to transplant centers, and performing more prerecovery organ analysis. Moreover, these strategies are needed to ensure that financial disincentives to DCD procurement and utilization do not reverse the gains made by expanding the organ donor pool using machine perfusion technologies., (Copyright © 2024 American Association for the Study of Liver Diseases.)

Introduction: In Italy, post-liver transplant (LT) hepatitis B virus (HBV) reinfection prophylaxis is frequently based on a combined regimen of anti-HBV immunoglobulin (HBIG) and oral antivirals. However, little information is available at the national level on the cost of LT and the contribution of HBV prophylaxis. This study aimed to quantify the direct healthcare cost for adult patients undergoing LT for HBV-related disease over a lifetime horizon and from the perspective of a National Healthcare Service., Methods: A pharmaco-economic model was implemented with a 4-tiered approach consisting of 1) preliminary literature research to define the research question; 2) pragmatic literature review to retrieve existing information and inform the model; 3) micro-simulated patient cycles; and 4) validation from a panel of national experts., Results: The average lifetime healthcare cost of LT for HBV-related disease was €395,986. The greatest cost drivers were post-transplant end-stage renal failure (31.9% of the total), immunosuppression (20.6%), and acute transplant phase (15.8%). HBV reinfection prophylaxis with HBIG and antivirals accounted for 12.4% and 6.4% of the total cost, respectively; however, lifetime HBIG prophylaxis was only associated with a 6.6% increase (~€422 k). Various sensitivity analyses have shown that discount rates have the greatest impact on total costs., Conclusion: This analysis showed that the burden of LT due to HBV is not only clinical but also economic., Competing Interests: BC, FF, and CV were employees of IQVIA Solutions S.r.l., which received a grant from Kedrion Biopharma Inc. to conduct the study. LC, PS, SF, AM, and MR received a fee from IQVIA Solutions S.r.l. as Advisors., (Copyright © 2024 Marzano, Canali, De Carlis, De Simone, Fiorentino, Rendina, Vassallo and Fagiuoli.)

Disparities exist in pediatric liver transplant (LT). We characterized barriers and facilitators to providing transplant and social care within pediatric LT clinics. This was a multicenter qualitative study. We oversampled caregivers reporting household financial strain, material economic hardship, or demonstrating poor health literacy. We also enrolled transplant team members. We conducted semistructured interviews with participants. Caregiver interviews focused on challenges addressing transplant and household needs. Transplant provider interviews focused on barriers and facilitators to providing social care within transplant teams. Interviews were recorded, transcribed, and coded according to the Capability, Opportunity, Motivation-Behavior model. We interviewed 27 caregivers and 27 transplant team members. Fifty-two percent of caregivers reported a household income <$60,000, and 62% reported financial resource strain. Caregivers reported experiencing (1) high financial burdens after LT, (2) added caregiving labor that compounds the financial burden, (3) dependency on their social network's generosity for financial and logistical support, and (4) additional support being limited to the perioperative period. Transplant providers reported (1) relying on the pretransplant psychosocial assessment for identifying social risks, (2) discomfort initiating social risk discussions in the post-transplant period, (3) reliance on social workers to address new social risks, and (4) social workers feeling overburdened by quantity and quality of the social work referrals. We identified barriers to providing effective social care in pediatric LT, primarily a lack of comfort in assessing and addressing new social risks in the post-transplant period. Addressing these barriers should enhance social care delivery and improve outcomes for these children., (Copyright © 2023 American Association for the Study of Liver Diseases.)

Background: Although Hispanic patients have high rates of end-stage liver disease and liver cancer, for which liver transplantation (LT) offers the best long-term outcomes, they are less likely to receive LT. Studies of end-stage renal disease patients and kidney transplant candidates have shown that targeted, culturally relevant interventions can increase the likelihood of Hispanic patients receiving kidney transplant. However, similar interventions remain largely unstudied in potential LT candidates., Methods: Referrals to a single center in Texas with a large Hispanic patient population were compared before (01/2018-12/2019) and after (7/2021-6/2023) the implementation of a targeted outreach program. Patient progress toward LT, reasons for ineligibility, and differences in insurance were examined between the two eras., Results: A greater proportion of Hispanic patients were referred for LT after the implementation of the outreach program (23.2% vs 26.2%, p = 0.004). Comparing the pre-outreach era to the post-outreach era, more Hispanic patients achieved waitlisting status (61 vs 78, respectively) and received a LT (971 vs 82, respectively). However, the proportion of Hispanic patients undergoing LT dropped from 30.2% to 20.3%. In the post-outreach era, half of the Hispanic patients were unable to get LT for financial reasons (112, 50.5%)., Conclusions: A targeted outreach program for Hispanic patients with end-stage liver disease effectively increased the total number of Hispanic LT referrals and recipients. However, many of the patients who were referred were ineligible for LT, most frequently for financial reasons. These results highlight the need for additional research into the most effective ways to ameliorate financial barriers to LT in this high-need community., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier B.V. All rights reserved.)

To control treatment pathways of transplant patients across healthcare sectors, a profound knowledge of the underlying cost structure is necessary. The aim of this study was to analyze the resource utilization of patients undergoing liver transplantation. Data on resource utilization for 182 liver-transplanted patients was investigated retrospectively. The observational period started with the entry on the waiting list and ended up to 3 years after transplantation. Median treatment cost was 144 424€. During waiting time, median costs amounted to 9466€; 72% of costs were attributed to inpatient care, 3% to outpatient care, and 26% to pharmaceuticals. During the first year after transplantation, median costs of 105 566€ were calculated; 83% were allocated for inpatient and 1% outpatient care, 14% for drugs, and 1% for rehabilitative care. During follow-up after the first year of transplantation, median costs amounted to 20 115€; 75% of these were caused by pharmaceuticals, 21% by inpatient, 4% by outpatient, and <1% by rehabilitative services. Subgroup analyses (e.g., for lab MELD scores) were done. Costs incurred by inpatient care and pharmaceuticals are the dominating cost factors. These findings encourage a debate on challenges and improvements for cost-efficient clinical management between different healthcare sectors. [ABSTRACT FROM AUTHOR]

Introduction: Several clinical studies have demonstrated the safety, feasibility, and efficacy of machine perfusion in liver transplantation, although its economic outcomes are still underexplored. This review aimed to examine the costs related to machine perfusion and its associated outcomes., Methods: Expert opinion of several groups representing different machine perfusion modalities. Critical analysis of the published literature reporting the economic outcomes of the most used techniques of machine perfusion in liver transplantation (normothermic and hypothermic ex situ machine perfusion and in situ normothermic regional perfusion)., Results: Machine perfusion costs include disposable components of the perfusion device, perfusate components, personnel and facility fees, and depreciation of the perfusion device or device lease fee. The limited current literature suggests that although this upfront cost varies between perfusion modalities, its use is highly likely to be cost-effective. Optimization of the donor liver utilization rate, local conditions of transplant programs (long waiting list times and higher MELD scores), a decreased rate of complications, changes in logistics, and length of hospital stay are potential cost savings points that must highlight the expected benefits of this intervention. An additional unaccounted factor is that machine perfusion optimizing donor organ utilization allows patients to be transplanted earlier, avoiding clinical deterioration while on the waiting list and the costs associated with hospital admissions and other required procedures., Conclusion: So far, the clinical benefits have guided machine perfusion implementation in liver transplantation. Albeit there is data suggesting the economic benefit of the technique, further investigation of its costs to healthcare systems and society and associated outcomes is needed., (© 2021 International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.)

Background: Value-based healthcare focuses on improving outcomes relative to cost. We aimed to study the impact of an enhanced recovery pathway for liver transplant recipients on providing value., Methods: In total, 379 liver recipients were identified: pre-enhanced recovery pathway (2017, n = 57) and post-enhanced recovery pathway (2018-2020, n = 322). The enhanced recovery pathway bundle was defined through multidisciplinary efforts and included optimal fluid management, end-of-case extubation, multimodal analgesia, and a standardized care pathway. Pre- and post-enhanced recovery pathway patients were compared with regard to extubation rates, lengths of stay, complications, readmissions, survival, and costs., Results: Pre- and post-enhanced recovery pathway recipient model for end-stage liver disease score and balance of risk scores were similar, although post-enhanced recovery pathway recipients had a higher median donor risk index (1.55 vs 1.39, P = .003). End-of-case extubation rates were 78% post-enhanced recovery pathway (including 91% in 2020) versus 5% pre-enhanced recovery pathway, with post-enhanced recovery pathway patients having decreased median intraoperative transfusion requirements (1,500 vs 3,000 mL, P < .001). Post-enhanced recovery pathway recipients had shorter median intensive care unit (1.6 vs 2.3 days, P = .01) and hospital stays (5.4 vs 8.0 days, P < .001). Incidence of severe (Clavien-Dindo ≥3) complications during the index hospitalization were similar between pre-enhanced recovery pathway versus post-enhanced recovery pathway groups (33% vs 23%, P = .13), as were 30-day readmissions (26% vs 33%, P = .44) and 1-year survival (93.0% vs 94.5%, P = .58). The post-enhanced recovery pathway cohort demonstrated a significant reduction in median direct cost per case ($11,406; P < .001)., Conclusion: Implementation of an enhanced recovery pathway in liver transplantation is feasible, safe, and effective in delivering value, even in the setting of complex surgical care., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Competing Interests: The authors declare no funding or conflicts of interest.

Background: Fast-track anesthesia in liver transplantation (LT) has been discussed over the past few decades; however, factors associated with immediate extubation after LT surgery are not well defined. This study aimed to identify predictive factors and examine impacts of immediate extubation on post-LT outcomes., Methods: A total of 279 LT patients between January 2014 and May 2017 were included. Primary outcome was immediate extubation after LT. Other postoperative outcomes included reintubation, intensive care unit stay and cost, pulmonary complications within 90 days, and 90-day graft survival. Logistic regression was performed to identify factors that were predictive for immediate extubation. A matched control was used to study immediate extubation effect on the other postoperative outcomes., Results: Of these 279 patients, 80 (28.7%) underwent immediate extubation. Patients with anhepatic time >75 minutes and with total intraoperative blood transfusion ≥12 units were less likely to be immediately extubated (odds ratio [OR], 0.48; 95% confidence interval [CI], 0.26-0.89; P = 0.02; OR, 0.11; 95% CI, 0.05-0.21; P < 0.001). The multivariable analysis showed immediate extubation significantly decreased the risk of pulmonary complications (OR, 0.34; 95% CI, 0.15-0.77; P = 0.01). According to a matched case-control model (immediate group [n = 72], delayed group [n = 72]), the immediate group had a significantly lower rate of pulmonary complications (11.1% versus 27.8%; P = 0.012). Intensive care unit stay and cost were relatively lower in the immediate group (2 versus 3 d; P = 0.082; $5700 versus $7710; P = 0.11). Reintubation rates (2.8% versus 2.8%; P > 0.9) and 90-day graft survival rates (95.8% versus 98.6%; P = 0.31) were similar., Conclusions: Immediate extubation post-LT in appropriate patients is safe and may improve patient outcomes and resource allocation., Competing Interests: The authors declare no funding or conflicts of interest., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The economic burden of Primary Biliary Cholangitis (PBC) has not been investigated at population-level. Aim of this study was to estimate the cost of illness of PBC in Lombardy, Italy., Methods: Individuals with PBC were identified through ICD-9-CM code 571.6 and/or medical exemption code 008.571.6, from the Banca Dati Assistito of Lombardy. Only health services (outpatient, inpatient activities and drugs) related to PBC were considered to estimate direct medical costs in 2017., Results: We identified 970 adult patients (83.5% females) with a mean age of 61 years. Global annual costs were equal to € 913,763 (€ 942 per patient), with € 459,506 (50.3%, € 474 per patient) deriving from hospitalizations (mostly due to liver transplantation, 30.5%, and cirrhosis complications, 20.6%). Costs from outpatient activities were € 109,090 (11.9%, € 112 per patient)., Conclusions: This study provides an overview of the costs attributed to PBC care and management, mainly related to hospitalizations for cirrhosis complications, which is necessary for assuring cost-effective introduction of novel therapies. Additional studies focused on indirect cost, e.g. overall loss of productivity, are warranted., Competing Interests: Conflict of interest All the authors do not have conflicts of interests to declare regarding this publication., (Copyright © 2020 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Competing Interests: The authors declare no funding or conflicts of interest.

Background: To investigate the value of European deprivation index (EDI) and hepatocellular carcinoma (HCC) characteristics and their relationships with outcome after liver transplantation (LT)., Methods: Patients undergoing LT for HCC were included from a national database (from "Agence de la Biomédecine" between 2006 and 2016. Characteristics of the patients were blindly extracted from the database. Thus, EDI was calculated in 5 quintiles and prognosis factors of survival were determined according to a Cox model., Results: Among the 3865 included patients, 33.9% were in the fifth quintile (quintile 1, N = 562 [14.5%]; quintile 2, N = 647 [16.7%]; quintile 3, N = 654 [16.9%]; quintile 4, N = 688 [17.8%]). Patients in each quintile were comparable regarding HCC history, especially median size of HCC, number of nodules of HCC and alpha-fetoprotein score. In the univariate analysis of the crude survival, having >2 nodules of HCC before LT and time on waiting list were associated with a higher risk of death (P < 0.0001 and P = 0.03, respectively). EDI, size of HCC, model for end-stage liver disease score, Child-Pugh score were not statistically significant in the crude and net survival. In both survival, time on waiting list and number of HCC ≥2 were independent factor of mortality after LT for HCC (P = 0.009 and 0.001, respectively, and P = 0.03 and 0.02, respectively)., Conclusions: EDI does not impact overall survival after LT for HCC. Number of HCC and time on waiting list are independent prognostic factors of survival after LT for HCC., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Previous studies have demonstrated disparities in transplantation for women, non-Caucasians, the uninsured or publicly insured, and rural populations. We sought to correlate transplant center characteristics with patient access to the waiting list and liver transplantation. We hypothesized that liver transplant centers vary greatly in providing equitable access to the waiting list and liver transplantation., Study Design: Center-specific, adult, deceased-donor liver transplant and waitlist data for the years 2013 to 2018 were obtained from the United Network for Organ Sharing. Waitlist race/ethnicity distributions from liver transplant centers performing ≥ 250 transplants over this period (n = 109) were compared with those of their donor service area, as calculated from 5-year US Census Bureau estimates of 2017. Center-specific characteristics correlating with disparities were analyzed using a linear regression model with a log transformed outcome., Results: Non-Hispanic Blacks (NHBs) are under-represented in liver transplant listing compared with center donation service area (88/109, 81%), whereas, non-Hispanic Whites are over-represented (65/109, 58%) (p < 0.0001). Hispanics were also under-represented on the waitlist at the majority of transplant centers (68/109, 62%) (p = 0.02). Although the racial/ethnic distribution of transplantation is more reflective of the waitlist, there is a higher than expected rate of transplantation for NHBs compared to the waitlist. Predictors of disparity in listing include percentage of transplant recipients at the center who had private insurance, racial composition of the donation service area, and the distance recipients had to travel for transplant., Conclusions: Non-Hispanic Blacks are listed for liver transplantation less than would be expected. Once listed, however, racial disparities in transplantation are greatly diminished. Improvements in access to adequate health insurance appear to be essential to diminishing disparities in access to this life-saving care., (Copyright © 2021 American College of Surgeons. Published by Elsevier Inc. All rights reserved.)

Previous research shows that countries with opt-out consent systems for organ donation conduct significantly more deceased-donor organ transplantations than those with opt-in systems. This paper investigates whether the higher transplantation rates in opt-out systems translate into equally lower death rates among organ patients registered on a waiting list (i.e., organ-patient mortality rates). We show that the difference between consent systems regarding kidney- and liver-patient mortality rates is significantly smaller than the difference in deceased-donor transplantation rates. This is likely due to different incentives between the consent systems. We find empirical evidence that opt-out systems reduce incentives for living donations, which explains our findings for kidneys. The results imply that focusing on deceased-donor transplantation rates alone paints an incomplete picture of opt-out systems' benefits, and that there are important differences between organs in this respect., Competing Interests: The authors have declared that no competing interests exist.

Background: High-quality estimates of health care costs are required to understand the burden of illness and to inform economic models. We estimated the costs associated with hepatitis C virus (HCV) infection from the public payer perspective in Ontario, Canada., Methods: In this population-based retrospective cohort study, we identified patients aged 18-105 years diagnosed with chronic HCV infection in Ontario from 2003 to 2014 using linked administrative data. We allocated the time from diagnosis until death or the end of follow-up (Dec. 31, 2016) to 9 mutually exclusive health states using validated algorithms: no cirrhosis, no cirrhosis (RNA negative) (i.e., cured HCV infection), compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, both decompensated cirrhosis and hepatocellular carcinoma, liver transplantation, terminal (liver-related) and terminal (non-liver-related). We estimated direct medical costs (in 2018 Canadian dollars) per 30 days per health state and used regression models to identify predictors of the costs., Results: We identified 48 239 patients with chronic hepatitis C, of whom 30 763 (63.8%) were men and 35 891 (74.4%) were aged 30-59 years at diagnosis. The mean 30-day costs were $798 (95% confidence interval [CI] $780-$816) ( n = 43 568) for no cirrhosis, $661 (95% CI $630-$692) ( n = 6422) for no cirrhosis (RNA negative), $1487 (95% CI $1375-$1599) ( n = 4970) for compensated cirrhosis, $3659 (95% CI $3279-$4039) ( n = 3151) for decompensated cirrhosis, $4238 (95% CI $3480-$4996) ( n = 550) for hepatocellular carcinoma, $8753 (95% CI $7130-$10 377) ( n = 485) for both decompensated cirrhosis and hepatocellular carcinoma, $4539 (95% CI $3746-$5333) ( n = 372) for liver transplantation, $11 202 (95% CI $10 645-$11 760) ( n = 3201) for terminal (liver-related) and $8801 (95% CI $8331-$9271) ( n = 5278) for terminal (non-liver-related) health states. Comorbidity was the most significant predictor of total costs for all health states., Interpretation: Our findings suggest that the financial burden of HCV infection is substantially higher than previously estimated in Canada. Our comprehensive, up-to-date cost estimates for clinically defined health states of HCV infection should be useful for future economic evaluations related to this disorder., Competing Interests: Competing interests: Murray Krahn and William Wong have received research support from the Canadian Liver Foundation. No other competing interests were declared., (© 2021 Joule Inc. or its licensors.)

Background: Socioeconomic status has been associated with inferior outcomes after multiple surgical procedures, but has not been well studied with respect to pediatric liver transplantation. This study evaluated the impact of insurance status (as a proxy for socioeconomic status) on patient and allograft survival in pediatric first-time liver transplant recipients., Methods: Our retrospective analysis of the UNOS data base from January 2002 through September 2017 revealed 6997 pediatric patients undergoing first-time isolated liver transplantation. A mixed Cox proportional hazards model adjusted for donor, recipient, and program characteristics determined the RR of insurance status on allograft and patient survival. All results were considered significant at P < .05. All statistical results were obtained using R version 3.5.1 and coxme version 2.2-10., Results: Medicaid status had a significant negative impact on long-term survival after controlling for multiple covariates. Pediatric patients undergoing first-time isolated liver transplantation with Medicaid insurance had a RR of 1.42 [confidence interval: 1.18-1.60] of post-transplant death., Conclusion: Pediatric patients undergoing first-time isolated liver transplantation have multiple risk factors that may impact long-term survival. Having Medicaid insurance almost doubles the chances of dying post-liver transplant. This patient population may require more global support post-transplant to improve long-term survival., (© 2020 Wiley Periodicals LLC.)

Concepts to ameliorate the continued mismatch between demand for liver allografts and supply include the acceptance of allografts that meet extended donor criteria (ECD). ECD grafts are generally associated with an increased rate of complications such as early allograft dysfunction (EAD). The costs of liver transplantation for the health care system with respect to specific risk factors remain unclear and are subject to change. We analyzed 317 liver transplant recipients from 2013 to 2018 for outcome after liver transplantation and hospital costs in a German transplant center. In our study period, 1-year survival after transplantation was 80.1% (95% confidence interval: 75.8%-84.6%) and median hospital stay was 33 days (interquartile rage: 24), with mean hospital costs of €115,924 (SD €113,347). There was a positive correlation between costs and laboratory Model for End-Stage Liver Disease score (r s  = 0.48, P  < 0.001), and the development of EAD increased hospital costs by €26,229. ECD grafts were not associated with a higher risk of EAD in our cohort. When adjusting for recipient-associated risk factors such as laboratory Model for End-Stage Liver Disease score, recipient age, and split liver transplantation with propensity score matching, only EAD and cold ischemia increased total costs. Conclusion: Our data show that EAD leads to significantly higher hospital costs for liver transplantation, which are primarily attributed to recipient health status. Strategies to reduce the incidence of EAD are needed to control costs in liver transplantation., (© 2020 The Authors. Hepatology Communications published by Wiley Periodicals LLC on behalf of the American Association for the Study of Liver Diseases.)

Background: Safety net hospitals have historically cared for a disproportionate number of patients of low socioeconomic status, racial and ethnic minorities, and patients with cancer. These innate challenges make safety net hospitals important in understanding how to improve access to cancer care in order to fit the needs of vulnerable patients and ultimately improve their outcomes. The purpose of this study is to characterize the current state and treatment of hepatocellular carcinoma (HCC) at Ben Taub Hospital, a safety net hospital in Houston, Texas., Materials and Methods: A retrospective chart review was performed to review the demographic characteristics, clinicopathologic data, treatment strategies, and outcomes of HCC patients at Ben Taub Hospital between January 2012 and December 2014., Results: Two-hundred twenty-six men and 78 women with a mean age of 58 y underwent evaluation. Most (87%) were either uninsured or covered by Medicaid. The majority (69%) of patients presented with advanced (stage 2 or more) disease, with 58% of patients presenting with multiple lesions. Of the 40% that presented with a solitary lesion, the average size was 4.97 cm. Transarterial chemoembolization was used in 37% of patients and sorafenib was given to 26% of patients. Five patients underwent successful transplant. One hundred seventeen (38%) patients died of their disease, 25 patients are alive with no evidence of disease, and 159 patients have been lost to follow-up., Conclusions: Most patients with HCC presented to this safety net hospital with advanced disease; however, multiple local and systemic treatments were offered. Screening programs to detect HCC at an earlier stage are essential for successful long-term outcomes in a resource-strapped hospital with limited access to liver transplantation., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: Vascular and biliary complications associated with liver transplants involve high morbidity and mortality as well as cost overrun for health systems. Efforts to prioritize their prevention require not only clinical information but also information on costs that reflect the economic burden on health systems. The objective of this study was to describe cost overrun incurred from early vascular and biliary complications after liver transplant., Methods: This cases series included liver transplant patients treated at the San Vicente Foundation University Hospital, Rionegro, Antioquia, from January 1, 2013, to December 31, 2018. All liver transplant patients treated during the above period were included; the absence of clinical records on the variables of interest was considered the exclusion criterion. A probabilistic analysis of patient cost was performed. Monte Carlo simulations as well as a 1-way sensitivity analysis per transplant cost component were performed., Results: Records from 154 patients were assessed. The average patient age was 56.9 (SD 10.9) years; 42.9% of patients were women. Of all, 36.4% patients were classified as Child C, and the average Model for End-Stage Liver Disease score was 19.6. The average cost for patients without complications was $27 834.82, whereas that for patients with early vascular complications was $36 747.83 and for those with early biliary complications was $38 523.74., Conclusion: Early vascular and biliary complications after liver transplant increase healthcare costs, with the increase being significant in patients with biliary complications., (Copyright © 2020. Published by Elsevier Inc.)

Background: Pulmonary function tests (PFTs) are currently recommended for liver transplant candidates. We hypothesized that PFTs may not provide added clinical value to the evaluation of liver transplant patients., Methods: We conducted a retrospective cohort study of adult cadaveric liver transplants from 2012 to 2018. Abnormal PFTs were defined as restrictive disease of diffusing capacity of the lungs for carbon monoxide (DLCO) <80% or obstructive disease of ratio of forced expiratory volume in the first 1 second to the first vital capacity of the lungs (FEV1/FVC) <70%., Results: We analyzed data on 415 liver transplant patients (358 abnormal PFT results and 57 normal results). The liver transplant patients with abnormal PFTs had no difference in number of intensive care unit (ICU) days ( P = .68), length of stay ( P = .24), or intubation days ( P = .33). There were no differences in pulmonary complications including pleural effusion ( P = .30), hemo/pneumothorax ( P = .74), pneumonia ( P = .66), acute respiratory distress syndrome ( P = .57), or pulmonary edema ( P = .73). The significant finding between groups was a higher rate of reintubation in liver transplant patients with normal PFTs ( P = .02). There was no difference in graft survival ( P = .53) or patient survival ( P = .42)., Discussion: Abnormal PFTs, found in 86% of liver transplant patients, did not correlate with complications, graft failure, or mortality. PFTs contribute to the high cost of liver transplants but do not help predict which patients are at risk of postoperative complications.

Background and Aims: Nonalcoholic steatohepatitis (NASH) may progress to advanced liver disease (AdvLD). This study characterized comorbidities, healthcare resource utilization (HCRU) and associated costs among hospitalized patients with AdvLD due to NASH in Italy., Methods and Results: Adult nonalcoholic fatty liver disease (NAFLD)/NASH patients from 2011 to 2017 were identified from administrative databases of Italian local health units using ICD-9-CM codes. Development of compensated cirrhosis (CC), decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC), or liver transplant (LT) was identified using first diagnosis date for each severity cohort (index-date). Patients progressing to multiple disease stages were included in >1 cohort. Patients were followed from index-date until the earliest of disease progression, end of coverage, death, or end of study. Within each cohort, per member per month values were annualized to calculate all-cause HCRU or costs(€) in 2017. Of the 9,729 hospitalized NAFLD/NASH patients identified, 97% were without AdvLD, 1.3% had CC, 3.1% DCC, 0.8% HCC, 0.1% LT. Comorbidity burden was high across all cohorts. Mean annual number of inpatient services was greater in patients with AdvLD than without AdvLD. Similar trends were observed in outpatient visits and pharmacy fills. Mean total annual costs increased with disease severity, driven primarily by inpatient services costs., Conclusion: NAFLD/NASH patients in Italy have high comorbidity burden. AdvLD patients had significantly higher costs. The higher prevalence of DCC compared to CC in this population may suggest challenges of effectively screening and identifying NAFLD/NASH patients. Early identification and effective management are needed to reduce risk of disease progression and subsequent HCRU and costs., Competing Interests: Declaration of Competing Interest This study was sponsored by Gilead Sciences, Inc., and executed by CliCon S.r.l on behalf of Gilead Sciences, Inc. The agreement signed by Clicon S.r.l. and Gilead does not create any entityship, joint venture or any similar relationship between parties. Clicon S.r.l. is an independent company. Neither CliCon S.r.l. nor any of their representatives are employees of Gilead for any purpose. SS, and LDE report no conflicts of interest in this work. JT and SS are employees of Gilead, Foster City, CA, USA. SP, MLP, and GM are consultants of Gilead Sciences, Inc. for this study., (Copyright © 2020 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

Background: Hepatic encephalopathy (HE) is a complication of cirrhosis of the liver causing neuropsychiatric abnormalities. Clinical manifestations of overt HE result in increased health care resource utilization and effects on patient quality of life. While lactulose has historically been the mainstay of treatment for acute HE and maintenance of remission, there is an unmet need for additional therapeutic options with a favorable adverse event profile. Compared with lactulose alone, rifaximin has demonstrated proven efficacy in complete reversal of HE and reduction in the incidence of HE recurrence, mortality, and hospitalizations. Evidence suggests the benefit of long-term prophylactic therapy with rifaximin; however, there is a need to assess the economic impact of rifaximin treatment in patients with HE., Objective: To assess the incremental cost-effectiveness of rifaximin ± lactulose versus lactulose monotherapy in patients with overt HE., Methods: A Markov model was developed in Excel with 4 health states (remission, overt HE, liver transplantation, and death) to predict costs and outcomes of patients with HE after initiation of maintenance therapy with rifaximin ± lactulose to avoid recurrent HE episodes. Cost-effectiveness of rifaximin was evaluated through estimation of incremental cost per quality-adjusted life-year (QALY) or life-year (LY) gained. Analyses were conducted over a lifetime horizon. One-way deterministic and probabilistic sensitivity analyses were conducted to assess uncertainty in results., Results: The rifaximin ± lactulose regimen provided added health benefits despite an additional cost versus lactulose monotherapy. Model results showed an incremental benefit of $29,161 per QALY gained and $27,762 per LY gained with rifaximin ± lactulose versus lactulose monotherapy. Probabilistic sensitivity analyses demonstrated that the rifaximin ± lactulose regimen was cost-effective ~99% of the time at a threshold of $50,000 per QALY/LY gained, which falls within the commonly accepted threshold for incremental cost-effectiveness., Conclusions: The clinical benefit of rifaximin, combined with an acceptable economic profile, demonstrates the advantages of rifaximin maintenance therapy as an important option to consider for patients at risk of recurrent HE., Disclosures: This analysis was funded by Salix Pharmaceuticals, a division of Bausch Health US. Salix and Xcenda collaborated on the methods, and Salix, Xcenda, Jesudian, and Ahmad collaborated on the writing of the manuscript and interpretation of results. Bozkaya and Migliaccio-Walle are employees of Xcenda. Ahmad reports speaker fees from Salix Pharmaceuticals, unrelated to this study. Jesudian reports consulting and speaker fees from Salix Pharmaceuticals, unrelated to this study. The results from this model were presented at AASLD: The Liver Meeting 2014; November 7-11; Boston, MA.

Background: The number of liver transplantations is increasing worldwide, and Brazil ranks in the second position. It has one of the biggest public health care systems, which is responsible for the coordination and financial funding of transplantation procedures. Meeting the demands of such a large system of transplantation has become a challenge, particularly when attempting to minimize costs of scarce and expensive resources. The aim of this study was to investigate the process of donation, the retrieval of organs, and the transplantation itself using engineering methods based on logistics analyses., Methods: Three steps were used: study planning, data gathering, and data analysis. Researchers surveyed professionals to acquire raw information based on their observations, experience, and knowledge. Then, a data analysis was conducted, putting together all the information gathered during the previous steps. Bias was removed, and conflicting perceptions were resolved in order to have a standard view on the transplantation process., Results: Data was gathered between 2014 and 2018 and included 5502 liver donors and 2678 (48.7%) patients who received liver transplants organs. A total of 2824 organs were refused because of logistics issues (transport and handling). Interviews of health care professionals enabled the design of a process map in which 4 stakeholders were identified: patient, physician, organ, and information., Conclusions: The liver transplantation process is analyzed based on a supply chain methodology applying this knowledge and putting together medical and engineering sciences to promote better efficiency and outcomes for the transplantation program. Future studies should focus on the implementation of these ideas aiming to promote optimization gains in any step of the process., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: The outcomes of liver transplantation may vary according to socioeconomic factors such as insurance coverage. The aim of this study was to assess the association between the type of insurance payer and outcomes of liver transplant candidates and recipients in the United States., Study Design: This was a retrospective cohort study of a national database., Methods: The US Scientific Registry of Transplant Recipients was used to select adults (≥18 years) wait-listed for liver transplantation in the United States (2001-2017); patients were followed until March 2018., Results: There were 177,862 liver transplant candidates with payer and outcomes data: The mean (SD) age was 54.1 (10.4) years, 64% were male, 39% had chronic hepatitis C with or without alcoholic liver disease (ALD), 19% had ALD alone, 17% had nonalcoholic steatohepatitis, and 16% had hepatocellular carcinoma. Fifty-nine percent were primarily covered by private insurance, 21% by Medicare, and 16% by Medicaid. After listing, 56% eventually received transplants (mean wait time of 229 days) and 22% dropped off the list. In multivariate analysis, adjusted for demographic and clinical factors, being covered by Medicare (odds ratio [OR], 0.81; 95% CI, 0.78-0.84) or Medicaid (OR, 0.76; 95% CI, 0.73-0.79) was independently associated with a lower chance of receiving a transplant (reference: private insurance). Posttransplant mortality was 11.6% at 1 year, 20.1% at 3 years, 26.8% at 5 years, and 41.6% at 10 years. Having Medicare (adjusted hazard ratio [aHR], 1.24; 95% CI, 1.17-1.31) or Medicaid (aHR, 1.14; 95% CI, 1.06-1.21) was independently associated with higher posttransplant mortality (P <.001) but not with the risk of graft loss (P >.05)., Conclusions: Liver transplant candidates covered by Medicare or Medicaid have poorer wait-list outcomes and higher posttransplant mortality.

Care for end-stage organ failure through transplant is one of the landmark accomplishments of the modern medicine. At the same time, organ transplant is a resource-intensive service that has been under increasing scrutiny in this era of cost containment. A detailed understanding of the economic implications of organ quality, recipient characteristics, and allocation policy is vital for the transplant professionals. Prior studies of kidney transplant economics demonstrate significant cost savings achieved by eliminating the need for long-term dialysis. However, transplant providers are experiencing higher financial costs because of changes in recipient characteristics. Liver transplantation economics are also more challenging because of organ allocation based on the severity of illness. Furthermore, the broader use of marginal organs has been demonstrated to increase costs. Novel strategies are vital to reduce the financial burden faced by the centers that perform transplantations on elevated risk patients and utilize lower quality organs., Competing Interests: Declaration of Competing interest None., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

The incidence of hepatocellular carcinoma (HCC) is increasing worldwide, with significant morbidity and associated costs. Treatment allocation depends on the stage of diagnosis; however, resource utilization can be significant across all stages. We aimed to summarize the available data on the cost effectiveness of surveillance of and treatments for HCC in the context of current treatment guidelines. We performed a focused review of studies investigating the economic burden and cost effectiveness of HCC surveillance treatment modalities published between January 2000 and January 2019. The overall economic burden of HCC is increasing in the USA and in several countries worldwide due to its rising incidence and the proliferation of therapies. Liver transplantation is a cost-effective strategy for early-stage HCC treatment in selected patients. In settings where liver transplantation is not available or in patients awaiting transplant, ablative or locoregional therapies are cost effective with increases in quality-adjusted life-years. First-line therapy with sorafenib for advanced stage HCC is cost effective in the treatment of compensated cirrhosis. The cost effectiveness of recently approved systemic therapies for advanced HCC require further investigation. Existing studies have shown that guideline-recommended surveillance techniques and several available therapies for the treatment of HCC are cost effective; however, there are limitations in the literature, including reliance on suboptimal modeling with incomplete/simplified model structure or inadequate inputs. With increasing therapeutic options in patients with HCC, understanding their relative value is critical in designing HCC treatment algorithms.

Background: Over the next 20 years, the number of patients on the waiting list for liver transplantation (LTx) is expected to increase by 23%, while pre-LTx costs should raise by 83%., Objective: To evaluate direct medical costs of the pre-LTx period from the perspective of a tertiary care center., Methods: The study included 104 adult patients wait-listed for deceased donor LTx between October 2012 and May 2016 whose treatment was fully provided at the study transplant center. Clinical and economic data were obtained from electronic medical records and from a hospital management software. Outcomes of interest and costs of patients on the waiting list were compared through the Kruskal-Wallis test. A generalized linear model with logit link function was used for multivariate analysis. P-values <0.05 were considered statistically significant., Results: The costs of patients who underwent LTx ($8,879.83; 95% CI 6,735.24-11,707.27; P<0.001) or who died while waiting ($6,464.73; 95% CI 3,845.75-10,867.28; P=0.04) were higher than those of patients who were excluded from the list for any reason except death ($4,647.78; 95% CI 2,469.35-8,748.04; P=0.254) or those who remained on the waiting list at the end of follow-up., Conclusion: Although protocols of inclusion on the waiting list vary among transplant centers, similar approaches exist and common problems should be addressed. The results of this study may help centers with similar socioeconomic realities adjust their transplant policies.

Online crowdfunding platforms such as GoFundMe are used to raise funds for health-related expenses associated with medical conditions such as organ transplantation. By investigating crowdfunding in Canadian organ transplantation, this study aimed to increase understanding of the motivations and outcomes of organ transplantation crowdfunding. Canadian liver and kidney transplantation campaigns posted to GoFundMe between May 30 & 31 2018 were identified and after exclusion, 258 kidney and 171 liver campaigns were included in study. These campaigns were coded for: worthiness of the campaign recipient, requested financial and non-monetary contributions, how monetary donations would be spent, and comments on the Canadian health system, among others. Results suggest Canadian organ donors, transplant candidates, recipients, and their families and caregivers experience significant financial difficulties not addressed by the public health system. Living and medication costs, transportation and relocation expenses, and income loss were the expenses most commonly highlighted by campaigners. Liver campaigns raised nearly half their goal while kidney campaigns received 11.5% of their requested amount. Findings highlight disease burden and the use of crowdfunding as a response to the extraordinary costs associated with organ transplantation. Although crowdfunding reduces some financial burden, it does not do so equitably and raises ethical concerns., Competing Interests: The authors have declared that no competing interests exist.

Aims: To assess stakeholder perspectives regarding the clinical utility of pharmacogenomic (PGx) testing following kidney, liver, and heart transplantation. Methods: We conducted individual semi-structured interviews and focus groups with kidney, liver, and heart transplantation patients and providers. We analyzed the qualitative data to identify salient themes. Results: The study enrolled 36 patients and 24 providers. Patients lacked an understanding about PGx, but expressed interest in PGx testing. Providers expressed willingness to use PGx testing, but reported barriers to implementation, such as lack of knowledge, lack of evidence demonstrating clinical utility, and patient healthcare burden. Conclusion: Patient and provider educational efforts, including foundational knowledge, clinical evidence, and applications to patient care beyond just immunosuppression, may be useful to facilitate the use of PGx testing in transplant medicine.