Publications by authors named "Sumeet K Asrani"

92 Publications

ACR Appropriateness Criteria® Radiologic Management of Portal Hypertension.

J Am Coll Radiol 2021 May;18(5S):S153-S173

Specialty Chair, Froedtert & The Medical College of Wisconsin, Milwaukee, Wisconsin, Chair, FMLH credentials committee, Division chief of IR at Medical College of Wisconsin.

Cirrhosis is a heterogeneous disease that cannot be studied as a single entity and is classified in two main prognostic stages: compensated and decompensated cirrhosis. Portal hypertension, characterized by a pathological increase of the portal pressure and by the formation of portal-systemic collaterals that bypass the liver, is the initial and main consequence of cirrhosis and is responsible for the majority of its complications. A myriad of treatment options exists for appropriately managing the most common complications of portal hypertension, including acute variceal bleeding and refractory ascites. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.
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http://dx.doi.org/10.1016/j.jacr.2021.02.013DOI Listing
May 2021

Chronic Kidney Disease after Simultaneous Liver Kidney Transplantation: Refining Patient Selection.

Liver Transpl 2021 Apr 20. Epub 2021 Apr 20.

Division of Nephrology and Hypertension, Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.

The number of simultaneous liver kidney transplantations (SLKT) performed in the United States have steadily increased over the last 15 years: approximately 1 out of 10 liver transplantations is a dual organ transplant.(1) Given the disparity between availability of donor organs and recipients awaiting transplant and the increasing numbers of patients on the waitlist with MELD ≥ 40 with the majority having acute kidney injury (AKI), the number of patients who will qualify for SLKT will most likely continue to increase.(2) Over the years, the transplant community has refined SLKT listing criteria in order to ensure appropriate utilization of kidney organs given the increasing numbers of SLKT.(2, 3) In 2017, new criteria were formalized to set up a "sustained AKI" and "chronic kidney disease" (CKD) criteria for listing for SLKT.
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http://dx.doi.org/10.1002/lt.26075DOI Listing
April 2021

Model for End Stage Liver Disease-Lactate score and prediction of inpatient mortality in critically ill patients with cirrhosis.

Liver Transpl 2021 Apr 20. Epub 2021 Apr 20.

Baylor University Medical Center, Baylor Scott and White, Dallas, TX, United States.

The burden of decompensated liver disease is high with a significant proportion of cirrhosis patients requiring inpatient hospitalization. Patients with cirrhosis have high inpatient mortality in the intensive care unit (ICU) setting, especially as compared to other chronic conditions. Objective models that predict short-term mortality at the time of ICU admission are needed for assessing response to therapy, transplant candidacy as well as futility of care.
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http://dx.doi.org/10.1002/lt.26076DOI Listing
April 2021

Long-term mortality risk stratification of liver transplant recipients: real-time application of deep learning algorithms on longitudinal data.

Lancet Digit Health 2021 05 12;3(5):e295-e305. Epub 2021 Apr 12.

Department of Computer Science, University of Toronto, Toronto, ON, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada; Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada; Vector Institute, Toronto, ON, Canada. Electronic address:

Background: Survival of liver transplant recipients beyond 1 year since transplantation is compromised by an increased risk of cancer, cardiovascular events, infection, and graft failure. Few clinical tools are available to identify patients at risk of these complications, which would flag them for screening tests and potentially life-saving interventions. In this retrospective analysis, we aimed to assess the ability of deep learning algorithms of longitudinal data from two prospective cohorts to predict complications resulting in death after liver transplantation over multiple timeframes, compared with logistic regression models.

Methods: In this machine learning analysis, model development was done on a set of 42 146 liver transplant recipients (mean age 48·6 years [SD 17·3]; 17 196 [40·8%] women) from the Scientific Registry of Transplant Recipients (SRTR) in the USA. Transferability of the model was further evaluated by fine-tuning on a dataset from the University Health Network (UHN) in Canada (n=3269; mean age 52·5 years [11·1]; 1079 [33·0%] women). The primary outcome was cause of death, as recorded in the databases, due to cardiovascular causes, infection, graft failure, or cancer, within 1 year and 5 years of each follow-up examination after transplantation. We compared the performance of four deep learning models against logistic regression, assessing performance using the area under the receiver operating characteristic curve (AUROC).

Findings: In both datasets, deep learning models outperformed logistic regression, with the Transformer model achieving the highest AUROCs in both datasets (p<0·0001). The AUROC for the Transformer model across all outcomes in the SRTR dataset was 0·804 (99% CI 0·795-0·854) for 1-year predictions and 0·733 (0·729-0·769) for 5-year predictions. In the UHN dataset, the AUROC for the top-performing deep learning model was 0·807 (0·795-0·842) for 1-year predictions and 0·722 (0·705-0·764) for 5-year predictions. AUROCs ranged from 0·695 (0·680-0·713) for prediction of death from infection within 5 years to 0·859 (0·847-0·871) for prediction of death by graft failure within 1 year.

Interpretation: Deep learning algorithms can incorporate longitudinal information to continuously predict long-term outcomes after liver transplantation, outperforming logistic regression models. Physicians could use these algorithms at routine follow-up visits to identify liver transplant recipients at risk for adverse outcomes and prevent these complications by modifying management based on ranked features.

Funding: Canadian Donation and Transplant Research Program, CIFAR AI Chairs Program.
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http://dx.doi.org/10.1016/S2589-7500(21)00040-6DOI Listing
May 2021

Financial Hardship from Medical Bills Among Adults with Chronic Liver Diseases: National Estimates from the United States.

Hepatology 2021 Mar 26. Epub 2021 Mar 26.

Division of Gastroenterology and Hepatology, and Division of Biomedical Informatics, Department of Medicine, University of California San Diego, La Jolla, CA, USA.

Background & Aims: Chronic liver diseases (CLD) affect ~2% of the US population and are associated with substantial burden of hospitalization and costs. We estimated the national burden and consequences of financial hardship from medical bills in individuals with CLD.

Approach & Results: Using the National Health Interview Survey from 2014-18, we identified individuals with self-reported CLD. We used complex weighted survey analysis to obtain national estimates of financial hardship from medical bills and other financial toxicity measures (cost-related medication non-adherence, personal and/or healthcare related financial distress, food insecurity). We evaluated the association of financial hardship from medical bills with unplanned healthcare utilization and work productivity, accounting for differences in age, sex, race/ethnicity, insurance, income, education and comorbidities. Of 3,666 (representing 5.3 million) US adults with CLD, 1,377 (representing 2.0 million; [37%, 95% CI: 35-39%]) reported financial hardship from medical bills, including 549 (representing 740,000; [14%, 95% CI: 13-16%]) who were unable to pay medical bills at all. Adults who were unable to pay medical bills had 8.4 times higher odds of cost-related medication non-adherence (aOR, 8.39 [95% CI, 5.72-12.32]), 6.3-times higher odds of financial distress (aOR, 6.33 [4.44-9.03]) and 5.6-times higher odds of food insecurity (aOR, 5.59 [3.74-8.37]), as compared to patients without financial hardship from medical bills. Patients unable to pay medical bills had 1.9-times higher odds of emergency department visits (aOR, 1.85 [1.33-2.57]), and 1.8-times higher odds of missing work due to disease (aOR, 1.83 [1.26-2.67]).

Conclusions: One in 3 adults with CLD experience financial hardship from medical bills, and frequently experience financial toxicity and unplanned healthcare utilization. These financial determinates of health have important implications in the context of value-based care.
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http://dx.doi.org/10.1002/hep.31835DOI Listing
March 2021

Race Adjustment in eGFR Equations Does Not Improve Estimation of Acute Kidney Injury Events in Patients with Cirrhosis.

Dig Dis Sci 2021 Mar 24. Epub 2021 Mar 24.

Division of Gastroenterology and Hepatology, University of Pennsylvania Perelman School of Medicine, 3400 Civic Center Boulevard, 4th Floor, South Pavilion, Philadelphia, PA, 19104, USA.

Background: Accuracy of glomerular filtration rate estimating (eGFR) equations has significant implications in cirrhosis, potentially guiding simultaneous liver kidney allocation and drug dosing. Most equations adjust for Black race, partially accounted for by reported differences in muscle mass by race. Patients with cirrhosis, however, are prone to sarcopenia which may mitigate such differences. We evaluated the association between baseline eGFR and incident acute kidney injury (AKI) in patients with cirrhosis with and without race adjustment.

Methods: We conducted a retrospective national cohort study of veterans with cirrhosis. Baseline eGFR was calculated using multiple eGFR equations including Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), both with and without race adjustment. Poisson regression was used to investigate the association between baseline eGFR and incident AKI events per International Club of Ascites criteria.

Results: We identified 72,267 patients with cirrhosis, who were 97.3% male, 57.8% white, and 19.7% Black. Over median follow-up 2.78 years (interquartile range 1.22-5.16), lower baseline eGFR by CKD-EPI was significantly associated with higher rates of AKI in adjusted models. For all equations this association was minimally impacted when race adjustment was removed. For example, removal of race adjustment from CKD-EPI resulted in a 0.1% increase in the association between lower eGFR and higher rate of AKI events per 15 mL/min/1.73 m change (p < 0.001).

Conclusions: Race adjustment in eGFR equations did not enhance AKI risk estimation in patients with cirrhosis. Further study is warranted to assess the impacts of removing race from eGFR equations on clinical outcomes and policy.
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http://dx.doi.org/10.1007/s10620-021-06943-1DOI Listing
March 2021

Editorial: stratifying risk of adverse outcomes in cirrhosis-the Hepquant SHUNT test. Authors' reply.

Aliment Pharmacol Ther 2021 04;53(8):941-942

Division of Gastroenterology and Hepatology, University of Colorado Denver School of Medicine, Aurora, CO, USA.

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http://dx.doi.org/10.1111/apt.16311DOI Listing
April 2021

Predicting clinical decompensation in patients with cirrhosis using the Hepquant-SHUNT test.

Aliment Pharmacol Ther 2021 04 8;53(8):928-938. Epub 2021 Feb 8.

Baylor University Medical Center, Dallas, TX, USA.

Background: Early identification of risk for decompensation in clinically stable cirrhotic patients helps specialists target early interventions and supports effective referrals from primary care providers to specialty centres.

Aims: To examine whether the HepQuant-SHUNT test (HepQuant LLC, Greenwood Village, Colorado, USA) predicts decompensation and the need for liver transplantation, hospitalisation or liver-related death.

Methods: Thirty-five compensated and 35 subjects with a previous episode of decompensation underwent the SHUNT Test and were followed for a median of 4.2 years. The disease severity index (DSI) (range 0-50) was examined for association with decompensation in compensated patients; and liver transplantation, liver-related death, and the number and days of liver related hospitalisations in all. DSI prediction of decompensation was also evaluated in 84 subjects with compensated cirrhosis from the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis Trial (HALT-C) followed for a median of 5.8 years.

Results: At baseline, subjects with prior decompensation had significantly higher DSI than compensated subjects (32.6 vs 20.9, P < 0.001). DSI ≥24 distinguished the decompensated from the compensated patients and independently predicted adverse clinical outcomes (hazard ratio: 4.92, 95% confidence interval: 1.42-17.06). In the HALT-C cohort, 65% with baseline DSI ≥24 vs 19% with DSI <24 experienced adverse clinical outcomes (relative risk 3.45, P < 0.0001).

Conclusions: The SHUNT test is a novel, noninvasive test that predicts risk of decompensation in previously compensated patients. DSI ≥24 is independently associated with risk for clinical decompensation, liver transplantation, death and hospitalisation.
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http://dx.doi.org/10.1111/apt.16283DOI Listing
April 2021

Predicting Long-Term Survival After Liver Transplantation in Patients With NASH Cirrhosis.

Clin Gastroenterol Hepatol 2021 Jan 16. Epub 2021 Jan 16.

Multi Organ Transplant Program, University Health Network, Toronto, Ontario, Canada; Division of Gastroenterology, Department of Medicine, University of Toronto, and Toronto General Hospital Research Institute, Toronto, Ontario, Canada. Electronic address:

Nonalcoholic steatohepatitis (NASH) cirrhosis is the second most common indication for liver transplantation (LT) in the United States. Patients are increasingly older at presentation, with higher rates of metabolic syndrome, obesity, hyperlipidemia, diabetes mellitus, and renal failure. They are also at higher risk of cardiovascular events and mortality while on the waiting list and in the post-transplant period. We sought to identify predictors of long-term benefit based on 5-year survival post-LT in NASH cirrhosis, thereby delineating those patients that derive a clear benefit from LT versus those in whom LT may be futile.
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http://dx.doi.org/10.1016/j.cgh.2021.01.021DOI Listing
January 2021

Medically tailored meals for the management of symptomatic ascites: the SALTYFOOD pilot randomized clinical trial.

Gastroenterol Rep (Oxf) 2020 Dec 12;8(6):453-456. Epub 2020 Nov 12.

Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA.

Background: Ascites is a costly, morbid complication of cirrhosis. Although a low-sodium diet is central to the clinical management of ascites, its efficacy is limited by poor adherence. We aimed to determine the feasibility and impact of low-sodium medically tailored meals (MTM) intervention.

Methods: We enrolled 40 persons with cirrhosis and ascites at the time of a paracentesis in a 12-week, 1:1 randomized trial of standard of care (SOC) (low-sodium diet educational handout) or MTM with <2,000 mg of sodium, >2,100 kcal, and >80 g of protein including a nocturnal protein supplement. We determined the proportion of eligible candidates recruited and adherence to MTM. The primary outcome was the number of paracenteses performed during weeks 0-12. We also collected ascites-specific quality-of-life (ASI-7) scores.

Results: The median age of the enrolled subjects was 54 (IQR, 47-63) years, 46% were female, with median MELD-Na 18 (IQR, 11-23) and albumin 2.7 (IQR, 2.5-3.3) g/dL. At baseline, subjects reported a median of two (IQR, 1-3) paracenteses in the prior 4 weeks. Adherence to the meal schedule was excellent save for when hospitalizations occurred. After 12 weeks, patients in the MTM arm required fewer paracenteses per week than those in the SOC group [median (IQR): 0.34 (0.14-0.54) vs 0.45 (0.25-0.64)]. During the trial, four (20%) SOC patients died, whereas two (10%) died and one (5%) was transplanted in the MTM arm. Ascites-specific quality of life improved to a greater degree in the MTM arm compared to the SOC arm, by 25% (IQR, -11% to 61%) vs 13% (IQR, -28% to 54%).

Conclusion: A trial of MTM for persons with ascites is feasible and potentially effective. Both arms experienced benefits, highlighting the role for improved education and closer monitoring in this challenging condition.
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http://dx.doi.org/10.1093/gastro/goaa059DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7793123PMC
December 2020

The Predictive Role of Model for End-Stage Liver Disease-Lactate and Lactate Clearance for In-Hospital Mortality Among a National Cirrhosis Cohort.

Liver Transpl 2021 02 9;27(2):177-189. Epub 2020 Dec 9.

Division of Gastroenterology and Hepatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.

The burden of cirrhosis hospitalizations is increasing. The admission Model for End-Stage Liver Disease-lactate (MELD-lactate) was recently demonstrated to be a superior predictor of in-hospital mortality compared with MELD in limited cohorts. We identified specific classes of hospitalizations where MELD-lactate may be especially useful and evaluated the predictive role of lactate clearance. This was a retrospective cohort study of 1036 cirrhosis hospitalizations for gastrointestinal bleeding, infection, or other portal hypertension-related indications in the Veterans Health Administration where MELD-lactate was measured on admission. Performance characteristics for in-hospital mortality were compared between MELD-lactate and MELD/MELD-sodium (MELD-Na), with stratified analyses of MELD categories (≤15, >15 to <25, ≥25) and reason for admission. We also incorporated day 3 lactate levels into modeling and tested for an interaction between day 1 MELD-lactate and day 3 lactate clearance. MELD-lactate had superior discrimination for in-hospital mortality compared with MELD or MELD-Na (area under the curve [AUC] 0.789 versus 0.776 versus 0.760, respectively; P < 0.001) and superior calibration. MELD-lactate had higher discrimination among hospitalizations with MELD ≤15 (AUC 0.763 versus 0.608 for MELD, global P = 0.01) and hospitalizations for infection (AUC 0.791 versus 0.674 for MELD, global P < 0.001). We found a significant interaction between day 1 MELD-lactate and day 3 lactate clearance; heat maps were created as clinical tools to risk-stratify patients based on these clinical data. MELD-lactate had significantly superior performance in predicting in-hospital mortality among patients hospitalized for infection and/or with MELD ≤15 when compared with MELD or MELD-Na. Incorporating day 3 lactate clearance may further improve prognostication.
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http://dx.doi.org/10.1002/lt.25913DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7880877PMC
February 2021

Reducing the Global Burden of Alcohol-Associated Liver Disease: A Blueprint for Action.

Hepatology 2021 May;73(5):2039-2050

Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN.

Alcohol-associated liver disease (ALD) is a major driver of global liver related morbidity and mortality. There are 2.4 billion drinkers (950 million heavy drinkers) and the lifetime prevalence of any alcohol use disorder (AUD) is 5.1%-8.6%. In 2017, global prevalence of alcohol-associated compensated and decompensated cirrhosis was 23.6 million and 2.5 million, respectively. Combined, alcohol-associated cirrhosis and liver cancer account for 1% of all deaths worldwide with this burden expected to increase. Solutions for this growing epidemic must be multi-faceted and focused on both population and patient-level interventions. Reductions in ALD-related morbidity and mortality require solutions that focus on early identification and intervention, reducing alcohol consumption at the population level (taxation, reduced availability and restricted promotion), and solutions tailored to local socioeconomic realities (unrecorded alcohol consumption, focused youth education). Simple screening tools and algorithms can be applied at the population level to identify alcohol misuse, diagnose ALD using non-invasive serum and imaging markers, and risk-stratify higher-risk ALD/AUD patients. Novel methods of healthcare delivery and platforms are needed (telehealth, outreach, use of non-healthcare providers, partnerships between primary and specialty care/tertiary hospitals) to proactively mitigate the global burden of ALD. An integrated approach that combines medical and AUD treatment is needed at the individual level to have the highest impact. Future needs include (1) improving quality of ALD data and standardizing care, (2) supporting innovative healthcare delivery platforms that can treat both ALD and AUD, (3) stronger and concerted advocacy by professional hepatology organizations, and (4) advancing implementation of digital interventions.
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http://dx.doi.org/10.1002/hep.31583DOI Listing
May 2021

Alcohol-associated hepatitis and liver transplantation: Mind the (racial, sex, economic, geographic, center, waitlist, and posttransplant outcomes) gap.

Am J Transplant 2021 03 29;21(3):921-922. Epub 2020 Aug 29.

Baylor University Medical Center, Dallas, Texas, USA.

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http://dx.doi.org/10.1111/ajt.16243DOI Listing
March 2021

Center Variation in Intention-to-Treat Survival Among Patients Listed for Liver Transplant.

Liver Transpl 2020 12 1;26(12):1582-1593. Epub 2020 Oct 1.

Baylor University Medical Center, Dallas, TX.

In the United States, centers performing liver transplant (LT) are primarily evaluated by patient survival within 1 year after LT, but tight clustering of outcomes allows only a narrow window for evaluation of center variation for quality improvement. Alternate measures more relevant to patients and the transplant community are needed. We examined adults listed for LT in the United States, using data submitted to the Scientific Registry of Transplant Recipients. Intention-to-treat (ITT) survival was defined as survival within 1 year from listing, regardless of transplant. Mixed effects/frailty models were used to assess center variation in ITT survival. Between January 2010 and December 2016, there were 66,428 new listings at 113 centers. Overall, median 1-year ITT survival was 79.8% (interquartile range [IQR], 76.1%-83.4%), whereas 1-year waiting-list (WL) survival was 75.8% (IQR, 71.2%-79.4%), and 1-year post-LT survival was 90.0% (IQR, 87.9%-91.8%). Higher rates of ITT mortality were correlated with increased WL mortality (correlation, r = 0.76), increased post-LT mortality (r = 0.31), lower volume centers (r = -0.34), and lower transplant rate ratio (r = -0.25). Similar patterns were observed in the subgroup of WL candidates listed with Model for End-Stage Liver Disease (MELD) ≥25: median 1-year ITT survival was 65.2% (IQR, 60.2%-72.6%), whereas 1-year post-LT survival was 87.5% (IQR, 84.0%-90.9%), and 1-year WL survival was 36.6% (IQR, 27.9%-47.0%). In mixed effects modeling, the transplant center was an independent predictor of ITT survival even after adjustment for age, sex, MELD, and sociodemographic variables. Center variation for ITT survival was larger compared with post-LT survival. The measurement of ITT outcome offers a complementary method to assess center performance. This is a first step toward understanding differences in program quality beyond patient and graft survival after LT.
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http://dx.doi.org/10.1002/lt.25852DOI Listing
December 2020

Patients with severe acute-on-chronic liver failure are disadvantaged by model for end-stage liver disease-based organ allocation policy.

Aliment Pharmacol Ther 2020 10 29;52(7):1204-1213. Epub 2020 Jul 29.

Liver Failure Group, Institute for Liver and Digestive Health, UCL Medical School, London, UK.

Background: Mortality for patients with acute-on-chronic liver failure (ACLF) may be underestimated by the model for end-stage liver disease-sodium (MELD-Na) score.

Aim: To assess waitlist outcomes across varying grades of ACLF among a cohort of patients listed with a MELD-Na score ≥35, and therefore having similar priority for liver transplantation.

Methods: We analysed the United Network for Organ Sharing (UNOS) database, years 2010-2017. Waitlist outcomes were evaluated using Fine and Gray's competing risks regression.

Results: We identified 6342 candidates at listing with a MELD-Na score ≥35, of whom 3122 had ACLF-3. Extra-hepatic organ failures were present primarily in patients with four to six organ failures. Competing risks regression revealed that candidates listed with ACLF-3 had a significantly higher risk for 90-day waitlist mortality (Sub-hazard ratio (SHR) = 1.41; 95% confidence interval [CI] 1.12-1.78) relative to patients with lower ACLF grades. Subgroup analysis of ACLF-3 revealed that both the presence of three organ failures (SHR = 1.40, 95% CI 1.20-1.63) or four to six organ failures at listing (SHR = 3.01; 95% CI 2.54-3.58) was associated with increased waitlist mortality. Candidates with four to six organ failures also had the lowest likelihood of receiving liver transplantation (SHR = 0.61, 95% CI 0.54-0.68). The Share 35 rule was associated with reduced 90-day waitlist mortality among the full cohort of patients listed with ACLF-3 and MELD-Na score ≥35 (SHR = 0.59; 95% CI 0.49-0.70). However, Share 35 rule implementation was not associated with reduced waitlist mortality among patients with four to six organ failures (SHR = 0.76; 95% CI 0.58-1.02).

Conclusions: The MELD-Na score disadvantages patients with ACLF-3, both with and without extra-hepatic organ failures. Incorporation of organ failures into allocation policy warrants further exploration.
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http://dx.doi.org/10.1111/apt.15988DOI Listing
October 2020

Feasibility and Procedural Safety of alfapump System Implantation by IR: Experience from the MOSAIC Study, a Multicenter, Open-Label Prospective Study in Cirrhotic Patients with Refractory Ascites.

J Vasc Interv Radiol 2020 Aug 10;31(8):1256-1262.e3. Epub 2020 Jul 10.

Division of Interventional Radiology, University of Virginia School of Medicine, Charlottesville, Virginia.

Purpose: To evaluate feasibility, procedural outcomes, and safety aspects of implantation of the alfapump system for management of refractory ascites by interventional radiology (IR) methods.

Materials And Methods: The multicenter open-label prospective MOSAIC study included 29 patients (mean age 60.0 y ± 9.9; range, 32-72 y, 17 [56.7%] male) with cirrhotic refractory ascites who received an alfapump system implanted by IR. The fully subcutaneous alfapump system consists of a pump and 2 silicone catheters, whose distal ends are inserted in the peritoneum and the bladder, respectively. The device moves ascites from the peritoneum to the bladder, reducing the requirement of paracentesis. Pumped volume and speed can be customized as required. The implant procedure was performed under general or local anesthesia. Both catheters were placed under ultrasound guidance. The pump was inserted in a subcutaneous pocket on the upper abdomen. Incidence and severity of procedure-related serious adverse events up to 3 months after implantation were recorded.

Results: Technical success was achieved in 29 (100%) IR implant procedures. The pump was usually implanted on the right abdomen (76.7%). In 5 patients, deviation from the Instructions for Use was required. Adverse events (requirement of additional incisions, postoperative bleed) occurred in 3 patients. At 3 months after implantation, 3 possibly procedure-related serious adverse events (ascites leakage, bacterial peritonitis, postoperative bleeding) had occurred. Two explantations (2/29; 6.8%) (cellulitis, pump pocket infection) and 4 reinterventions (pump or catheter replacement) were required, corresponding to an adverse event incidence rate of 9/29 (31.0%).

Conclusions: Placement of the alfapump using IR methods is both feasible and technically successful.
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http://dx.doi.org/10.1016/j.jvir.2020.02.005DOI Listing
August 2020

When Is a Critically Ill Cirrhotic Patient Too Sick to Transplant? Development of Consensus Criteria by a Multidisciplinary Panel of 35 International Experts.

Transplantation 2021 Mar;105(3):561-568

Department of Hepatobiliopancreatic Surgery and Liver Transplantation, Beaujon hospital, AP-HP.Nord, Inserm UMR_S1149, Inserm et Université de Paris, Paris, France.

Background: Critically ill cirrhotic patients are increasingly transplanted, but there is no consensus about futile liver transplantation (LT). Therefore, the decision to delay or deny LT is often extensively debated. These debates arise from different opinions of futility among transplant team members. This study aims to achieve a multinational and multidisciplinary consensus on the definition of futility in LT and to develop well-articulated criteria for not proceeding with LT due to futility.

Methods: Thirty-five international experts from anesthesiology/intensive care, hepatology, and transplant surgery were surveyed using the Delphi method. More than 70% of similar answers to a question were necessary to define agreement.

Results: The panel recommended patient and graft survival at 1 year after LT to define futility. Severe frailty and persistent fever or <72 hours of appropriate antimicrobial therapy in case of ongoing sepsis were considered reasons to delay LT. A simple assessment of the number of organs failing was considered the most appropriate way to decide whether LT should be delayed or denied, with respiratory, circulatory and metabolic failures having the most influence in this decision. The thresholds of severity of organ failures contraindicating LT for which a consensus was achieved were a Pao2/FiO2 ratio<150 mm Hg, a norepinephrine dose >1 μg/kg per minute and a serum lactate level >9 mmol/L.

Conclusions: Our expert panel provides a consensus on the definition of futile LT and on specific criteria for postponing or denying LT. A framework that may facilitate the decision if a patient is too sick for transplant is presented.
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http://dx.doi.org/10.1097/TP.0000000000003364DOI Listing
March 2021

ACR Appropriateness Criteria® Chronic Liver Disease.

J Am Coll Radiol 2020 May;17(5S):S70-S80

Specialty Chair, Virginia Commonwealth University Medical Center, Richmond, Virginia.

The liver fibrosis stage is the most important clinical determinate of morbidity and mortality in patients with chronic liver diseases. With newer therapies, liver fibrosis can be stabilized and possibly reversed, thus accurate diagnosis and staging of liver fibrosis are clinically important. Ultrasound, CT, and conventional MRI can be used to establish the diagnosis of advanced fibrosis/cirrhosis but have limited utility for assessing earlier stages of fibrosis. Elastography-based ultrasound and MRI techniques are more useful for assessment of precirrhotic hepatic fibrosis. In patients with advanced fibrosis at risk for hepatocellular carcinoma (HCC), ultrasound is the surveillance modality recommended by international guidelines in nearly all circumstances. However, in patients in whom ultrasound does not assess the liver well, including those with severe steatosis or obesity, multiphase CT or MRI may have a role in surveillance for HCC. Both multiphase CT and MRI can be used for continued surveillance in patients with a history of HCC, and contrast-enhanced ultrasound may have an emerging role in this setting. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment.
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http://dx.doi.org/10.1016/j.jacr.2020.01.023DOI Listing
May 2020

Discovery and validation of a novel blood-based molecular biomarker of rejection following liver transplantation.

Am J Transplant 2020 08 25;20(8):2173-2183. Epub 2020 May 25.

University of Arizona College of Medicine, Tucson, Arizona.

Noninvasive biomarker profiles of acute rejection (AR) could affect the management of liver transplant (LT) recipients. Peripheral blood was collected following LT for discovery (Northwestern University [NU]) and validation (National Institute of Allergy and Infectious Diseases Clinical Trials in Organ Transplantation [CTOT]-14 study). Blood gene profiling was paired with biopsies showing AR or ADNR (acute dysfunction no rejection) as well as stable graft function samples (Transplant eXcellent-TX). CTOT-14 subjects had serial collections prior to AR, ADNR, TX, and after AR treatment. NU cohort gene expression (46 AR, 45 TX) was analyzed using random forest models to generate a classifier training set (36 gene probe) distinguishing AR vs TX (area under the curve 0.92). The algorithm and threshold were locked and tested on the CTOT-14 validation cohort (14 AR, 50 TX), yielding an accuracy of 0.77, sensitivity 0.57, specificity 0.82, positive predictive value (PPV) 0.47, and negative predictive value (NPV) 0.87 for AR vs TX. The probability score line slopes were positive preceding AR, and negative preceding TX and non-AR (TX + ADNR) (P ≤ .001) and following AR treatment. In conclusion, we have developed a blood biomarker diagnostic for AR that can be detected prior to AR-associated graft injury as well a normal graft function (non-AR). Further studies are needed to evaluate its utility in precision-guided immunosuppression optimization following LT.
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http://dx.doi.org/10.1111/ajt.15953DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7496674PMC
August 2020

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Hepatology 2020 11 20;72(5):1884. Epub 2020 Oct 20.

Baylor University Medical Center, Baylor Scott and White, Dallas, TX.

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http://dx.doi.org/10.1002/hep.31287DOI Listing
November 2020

The COVID-19 pandemic will have a long-lasting impact on the quality of cirrhosis care.

J Hepatol 2020 08 13;73(2):441-445. Epub 2020 Apr 13.

Baylor University Medical Center, Dallas, Texas.

The coronavirus disease 2019 (COVID-19) pandemic has shattered the meticulously developed processes by which we delivered quality care for patients with cirrhosis. Care has been transformed by the crisis, but enduring lessons have been learned. In this article, we review how COVID-19 will impact cirrhosis care. We describe how this impact unfolds over 3 waves; i) an intense period with prioritized high-acuity care with delayed elective procedures and routine care during physical distancing, ii) a challenging 'return to normal' following the end of physical distancing, with increased emergent decompensations, morbidity, and systems of care overwhelmed by the backlog of deferred care, and iii) a protracted period of suboptimal outcomes characterized by missed diagnoses, progressive disease and loss to follow-up. We outline the concrete steps required to preserve the quality of care provided to patients with cirrhosis. This includes an intensification of the preventative care provided to patients with compensated cirrhosis, proactive chronic disease management, robust telehealth programs, and a reorganization of care delivery to provide a full service of care with flexible clinical staffing. Managing the pandemic of a serious chronic disease in the midst of a global infectious pandemic is challenging. It is incumbent upon the entire healthcare establishment to be strong enough to weather the storm. Change is needed.
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http://dx.doi.org/10.1016/j.jhep.2020.04.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7194911PMC
August 2020

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Liver Transpl 2020 07 6;26(7):952-953. Epub 2020 May 6.

Baylor University Medical Center, Dallas, TX.

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http://dx.doi.org/10.1002/lt.25763DOI Listing
July 2020

Not All Episodes of Acute Kidney Injury Are Equal in Patients With Cirrhosis, Based on Patterns of Renal Dysfunction.

Clin Gastroenterol Hepatol 2020 07 14;18(8):1694-1695. Epub 2020 Mar 14.

Department of Medicine, Baylor University Medical Center, Dallas, Texas.

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http://dx.doi.org/10.1016/j.cgh.2020.03.022DOI Listing
July 2020

Model for End-Stage Liver Disease-Lactate and Prediction of Inpatient Mortality in Patients With Chronic Liver Disease.

Hepatology 2020 11;72(5):1747-1757

Baylor University Medical Center, Baylor Scott and White, Dallas, TX.

Background And Aims: Compared to other chronic diseases, patients with chronic liver disease (CLD) have significantly higher inpatient mortality; accurate models to predict inpatient mortality are lacking. Serum lactate (LA) may be elevated in patients with CLD due to both tissue hypoperfusion as well as decreased LA clearance. We hypothesized that a parsimonious model consisting of Model for End-Stage Liver Disease (MELD) and LA at admission may predict inpatient mortality in patients with CLD.

Approach And Results: We examined all patients with CLD in two large and diverse health care systems in Texas (North Texas [NTX] and Central Texas [CTX]) between 2010 and 2015. We developed (n = 3,588) and validated (n = 1,804) a model containing MELD and LA measured at the time of hospitalization. We further validated the model in a second cohort of 14 tertiary care hepatology centers that prospectively enrolled nonelective hospitalized patients with cirrhosis (n = 726). MELD-LA was an excellent predictor of inpatient mortality in development (concordance statistic [C-statistic] = 0.81, 95% confidence interval [CI] 0.79-0.82) and both validation cohorts (CTX cohort, C-statistic = 0.85, 95% CI 0.78-0.87; multicenter cohort C-statistic = 0.82, 95% CI 0.74-0.88). MELD-LA performed especially well in patients with specific cirrhosis diagnoses (C-statistic = 0.84, 95% CI 0.81-0.86) or sepsis (C-statistic = 0.80, 95% CI 0.78-0.82). For MELD score 25, inpatient mortality rates were 11.2% (LA = 1 mmol/L), 19.4% (LA = 3 mmol/L), 34.3% (LA = 5 mmol/L), and >50% (LA > 8 mmol/L). A linear increase (P < 0.01) was seen in MELD-LA and increasing number of organ failures. Overall, use of MELD-LA improved the risk prediction in 23.5% of patients compared to MELD alone.

Conclusions: MELD-LA (bswh.md/meldla) is an early and objective predictor of inpatient mortality and may serve as a model for risk assessment and guide therapeutic options.
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http://dx.doi.org/10.1002/hep.31199DOI Listing
November 2020

Improvement in Quality of Life and Decrease in Large-Volume Paracentesis Requirements With the Automated Low-Flow Ascites Pump.

Liver Transpl 2020 05 22;26(5):651-661. Epub 2020 Mar 22.

Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN.

The automated low-flow ascites pump (alfapump) is an implantable device that drains ascites directly into the urinary bladder. We studied its safety (absence of serious complications) and efficacy (decreased large-volume paracentesis [LVP] requirement and improved quality of life [QoL]) in the management of ascites in a cohort of North American patients with cirrhosis and recurrent ascites ineligible for transjugular intrahepatic portosystemic shunt (TIPS). QoL was measured by the Chronic Liver Disease Questionnaire (CLDQ) and Ascites Questionnaire (Ascites Q). Following alfapump implantation, patients were monitored for ascites control, laboratory abnormalities, QoL, adverse events, and survival at 12 months. A total of 30 patients (60.0 ± 9.9 years; 57% male; Model for End-Stage Liver Disease score, 11.4 ± 2.7) received an alfapump, mostly by an interventional radiology approach (97%), followed by longterm prophylactic antibiotics. The alfapump removed a mean ascites volume of 230.6 ± 148.9 L/patient at 12 months, dramatically reducing the mean LVP frequency from 2.4 ± 1.4/patient/month before pump implantation to 0.2 ± 0.4/patient/month after pump implantation. All surviving patients had improved QoL (baseline versus 3 months; CLDQ, 3.9 ± 1.21 versus 5.0 ± 1.0; Ascites Q, 51.7 ± 21.9 versus 26.7 ± 18.6; P < 0.001 for both) and a better biochemical index of nutritional status (prealbumin 87.8 ± 37.5 versus 102.9 ± 45.3 mg/L at 3 months; P = 0.04). Bacterial infections (15 events in 13 patients), electrolyte abnormalities (11 events in 6 patients), and renal complications (11 events in 9 patients) were the most common severe adverse events. By 12 months, 4 patients died from complications of cirrhosis. Alfapump insertion may be a definitive treatment for refractory ascites in cirrhosis, especially in patients who are not TIPS candidates.
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http://dx.doi.org/10.1002/lt.25724DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7216956PMC
May 2020

Liver transplantation and chronic disease management: Moving beyond patient and graft survival.

Am J Transplant 2020 03 10;20(3):629-630. Epub 2020 Jan 10.

Baylor University Medical Center, Dallas, Texas.

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http://dx.doi.org/10.1111/ajt.15749DOI Listing
March 2020

Meeting Report: The Dallas Consensus Conference on Liver Transplantation for Alcohol Associated Hepatitis.

Liver Transpl 2020 01;26(1):127-140

Baylor University Medical Center, Dallas, TX.

Liver transplantation (LT) for alcohol associated hepatitis (AH) remains controversial. We convened a consensus conference to examine various aspects of LT for AH. The goal was not to unequivocally endorse LT for AH; instead, it was to propose recommendations for programs that perform or plan to perform LT for AH. Criteria were established to determine candidacy for LT in the setting of AH and included the following: (1) AH patients presenting for the first time with decompensated liver disease that are nonresponders to medical therapy without severe medical or psychiatric comorbidities; (2) a fixed period of abstinence prior to transplantation is not required; and (3) assessment with a multidisciplinary psychosocial team, including a social worker and an addiction specialist/mental health professional with addiction and transplantation expertise. Supporting factors included lack of repeated unsuccessful attempts at addiction rehabilitation, lack of other substance use/dependency, acceptance of diagnosis/insight with a commitment of the patient/family to sobriety, and formalized agreement to adhere to total alcohol abstinence and counseling. LT should be avoided in AH patients who are likely to spontaneously recover. Short-term and longterm survival comparable to other indications for LT must be achieved. There should not be further disparity in LT either by indication, geography, or other sociodemographic factors. Treatment of alcohol-use disorders should be incorporated into pre- and post-LT care. The restrictive and focused evaluation process described in the initial LT experience for AH worldwide may not endure as this indication gains wider acceptance at more LT programs. Transparency in the selection process is crucial and requires the collection of objective data to assess outcomes and minimize center variation in listing. Oversight of program adherence is important to harmonize listing practices and outcomes.
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http://dx.doi.org/10.1002/lt.25681DOI Listing
January 2020

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Authors:
Sumeet K Asrani

Hepatology 2020 04 18;71(4):1523. Epub 2020 Mar 18.

Baylor University Medical Center, Dallas, TX.

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http://dx.doi.org/10.1002/hep.31006DOI Listing
April 2020

MELD-GRAIL-Na: Glomerular Filtration Rate and Mortality on Liver-Transplant Waiting List.

Hepatology 2020 05 29;71(5):1766-1774. Epub 2020 Jan 29.

Baylor University Medical Center, Dallas, TX.

Background And Aims: Among patients with cirrhosis awaiting liver transplantation, prediction of wait-list (WL) mortality is adjudicated by the Model for End Stage Liver Disease-Sodium (MELD-Na) score. Replacing serum creatinine (SCr) with estimated glomerular filtration rate (eGFR) in the MELD-Na score may improve prediction of WL mortality, especially for women and highest disease severity.

Approach And Results: We developed (2014) and validated (2015) a model incorporating eGFR using national data (n = 17,095) to predict WL mortality. Glomerular filtration rate (GFR) was estimated using the GFR assessment in liver disease (GRAIL) developed among patients with cirrhosis. Multivariate Cox proportional hazard analysis models were used to compare the predicted 90-day WL mortality between MELD-GRAIL-Na (re-estimated bilirubin, international normalized ratio [INR], sodium, and GRAIL) versus MELD-Na. Within 3 months, 27.8% were transplanted, 4.3% died on the WL, and 4.7% were delisted for other reasons. GFR as estimated by GRAIL (hazard ratio [HR] 0.382, 95% confidence interval [CI] 0.344-0.424) and the re-estimated model MELD-GRAIL-Na (HR 1.212, 95% CI 1.199-1.224) were significant predictors of mortality or being delisted on the WL within 3 months. MELD-GRAIL-Na was a better predictor of observed mortality at highest deciles of disease severity (≥ 27-40). For a score of 32 or higher (observed mortality 0.68), predicted mortality was 0.67 (MELD-GRAIL-Na) and 0.51 (MELD-Na). For women, a score of 32 or higher (observed mortality 0.67), the predicted mortality was 0.69 (MELD-GRAIL-Na) and 0.55 (MELD-Na). In 2015, use of MELD-GRAIL-Na as compared with MELD-Na resulted in reclassification of 16.7% (n = 672) of patients on the WL.

Conclusion: Incorporation of eGFR likely captures true GFR better than SCr, especially among women. Incorporation of MELD-GRAIL-Na instead of MELD-Na may affect outcomes for 12%-17% awaiting transplant and affect organ allocation.
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http://dx.doi.org/10.1002/hep.30932DOI Listing
May 2020