An Evaluation of Critical Factors for the Cost-Effectiveness of Real-Time Computer-Aided Detection: Sensitivity and Threshold Analyses Using a Microsimulation Model.

BACKGROUND & AIMS: The use of computer-aided detection (CAD) increases the adenoma detection rates (ADRs) during colorectal cancer (CRC) screening/surveillance. This study aimed to evaluate the requirements for CAD to be cost-effective and the impact of CAD on adenoma detection by endoscopists with different ADRs. METHODS: We developed a semi-Markov microsimulation model to compare the effectiveness of traditional colonoscopy (mean ADR, 26%) to colonoscopy with CAD (mean ADR, 37%). CAD was modeled as having a $75 per-procedure cost. Extensive 1-way sensitivity and threshold analysis were performed to vary cost and ADR of CAD. Multiple scenarios evaluated the potential effect of CAD on endoscopists' ADRs. Outcome measures were reported in incremental cost-effectiveness ratios, with a willingness-to-pay threshold of $100,000/quality-adjusted life year. RESULTS: When modeling CAD improved ADR for all endoscopists, the CAD cohort had 79 and 34 fewer lifetime CRC cases and deaths, respectively, per 10,000 persons. This scenario was dominant with a cost savings of $143 and incremental effectiveness of 0.01 quality-adjusted life years. Threshold analysis demonstrated that CAD would be cost-effective up to an additional cost of $579 per colonoscopy, or if it increases ADR from 26% to at least 30%. CAD reduced CRC incidence and mortality when limited to improving ADRs for low-ADR endoscopists (ADR <25%), with 67 fewer CRC cases and 28 CRC deaths per 10,000 persons compared with traditional colonoscopy. CONCLUSIONS: As CAD is implemented clinically, it needs to improve mean ADR from 26% to at least 30% or cost less than $579 per colonoscopy to be cost-effective when compared with traditional colonoscopy. Further studies are needed to understand the impact of CAD when used in community practice.

Cost-effectiveness of second-line axicabtagene ciloleucel in relapsed refractory diffuse large B-cell lymphoma.

The ZUMA-7 (Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma) study showed that axicabtagene ciloleucel (axi-cel) improved event-free survival (EFS) compared with standard of care (SOC) salvage chemoimmunotherapy followed by autologous stem cell transplant in primary refractory/early relapsed diffuse large B-cell lymphoma (DLBCL); this led to its recent US Food and Drug Administration approval in this setting. We modeled a hypothetical cohort of US adults (mean age, 65 years) with primary refractory/early relapsed DLBCL by developing a Markov model (lifetime horizon) to model the cost-effectiveness of second-line axi-cel compared with SOC using a range of plausible long-term outcomes. EFS and OS were estimated from ZUMA-7. Outcome measures were reported in incremental cost-effectiveness ratios, with a willingness-to-pay (WTP) threshold of $150 000 per quality-adjusted life-year (QALY). Assuming a 5-year EFS of 35% with second-line axi-cel and 10% with SOC, axi-cel was cost-effective at a WTP of $150 000 per QALY ($93 547 per QALY). axi-cel was no longer cost-effective if its 5-year EFS was ≤26.4% or if it cost more than $972 061 at a WTP of $150 000. Second-line axi-cel was the cost-effective strategy in 73% of the 10 000 Monte Carlo iterations at a WTP of $150 000. If the absolute benefit in EFS is maintained over time, second-line axi-cel for aggressive relapsed/refractory DLBCL is cost-effective compared with SOC at a WTP of $150 000 per QALY. However, its cost-effectiveness is highly dependent on long-term outcomes. Routine use of second-line chimeric antigen receptor T-cell therapy would add significantly to health care expenditures in the United States (more than $1 billion each year), even when used in a high-risk subpopulation. Further reductions in the cost of chimeric antigen receptor T-cell therapy are needed to be affordable in many regions of the world.

Cost-effectiveness of polatuzumab vedotin combined with chemoimmunotherapy in untreated diffuse large B-cell lymphoma.

In patients with treatment-naive diffuse large B-cell lymphoma (DLBCL), the POLARIX study (A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone [R-CHP] Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone [R-CHOP] in Participants With Diffuse Large B-Cell Lymphoma) reported a 6.5% improvement in the 2-year progression-free survival (PFS), with no difference in overall survival (OS) or safety using polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) compared with standard rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). We evaluated the cost-effectiveness of pola-R-CHP for DLBCL. We modeled a hypothetical cohort of US adults (mean age, 65 years) with treatment-naive DLBCL by developing a Markov model (lifetime horizon) to model the cost-effectiveness of pola-R-CHP and R-CHOP using a range of plausible long-term outcomes. Progression rates and OS were estimated from POLARIX. Outcome measures were reported in incremental cost-effectiveness ratios, with a willingness-to-pay (WTP) threshold of $150 000 per quality-adjusted life-year (QALY). Assuming a 5-year PFS of 69.6% with pola-R-CHP and 62.7% with R-CHOP, pola-R-CHP was cost-effective at a WTP of $150 000 (incremental cost-effectiveness ratio, $84 308/QALY). pola-R-CHP was no longer cost-effective if its 5-year PFS was 66.1% or lower. One-way sensitivity analysis revealed that pola-R-CHP is cost-effective up to a cost of $276 312 at a WTP of $150 000. pola-R-CHP was the cost-effective strategy in 56.6% of the 10 000 Monte Carlo iterations at a WTP of $150 000. If the absolute benefit in PFS is maintained over time, pola-R-CHP is cost-effective compared with R-CHOP at a WTP of $150 000/QALY. However, its cost-effectiveness is highly dependent on its long-term outcomes and costs of chimeric antigen receptor T-cell therapy. Routine usage of pola-R-CHP would add significantly to health care expenditures. Price reductions or identification of subgroups that have maximal benefit would improve cost-effectiveness.

Hidden Dangers of Frailty: Higher Mortality, Complications and Costs in Acute Pancreatitis.

BACKGROUND: Frailty is a clinically recognizable state of increased vulnerability due to age-related decline in reserve and function across multiple physiologic systems that compromises the ability to cope with acute stress. As frailty is being identified as an important risk factor in outcomes of gastrointestinal pathologies, we aimed to assess outcomes in patients with acute pancreatitis within this cohort. METHOD: We conducted a retrospective study using the Nationwide Inpatient Sample (NIS) database. ICD-10 codes were used to inquire for patients admitted with acute pancreatitis between September 2015 through 2017. ICD-10 codes corresponding to the Hospital Frailty Risk Score (HFRS) were used to divide the study sample into 2 cohorts: low risk (< 5 points) and intermediate or high risk (> 5 points). To calculate the points, we fitted a logistic regression model that included membership of the frail group as the binary dependent variable (frail vs. non-frail) and the set of ICD-10 codes as binary predictor variables (1 = present, 0 = absent for each code). To simplify the calculation and interpretation, we multiplied regression coefficients by five to create a points system, so that a certain number of points are awarded for each ICD-10 code and added together to create the final frailty risk score. Multivariate regression analysis was performed to find adjusted mortality. RESULTS: Out of a total of 1,267,744 patients admitted with acute pancreatitis, 728,953 (57.5%) were identified as intermediate and high risk (> 5 points) (study cohort) and 538,781 (42.5%) as low risk (< 5 points). The mean age in the study cohort was 64.8 ± 12.6 and that in the low-risk group was 58.6 ± 9.5. Most of the patients in both groups were males and Caucasians; Medicare was the predominant insurance provider. A majority of the admissions in both groups were in an urban teaching hospital and were emergency. (Table 1). The primary outcome was in-hospital mortality which was significantly higher in the study cohort as compared to the low-risk group (4.3% vs. 2.5%, p < 0.0001). The age-adjusted Odds ratio of mortality was 1.72(95% CI (Confidence Interval) 1.65-1.80, p < 0.05). When compared between the two groups; median length of stay (6 vs. 4); hospitalization cost ($14,412 vs. $10,193), disposition to a skilled nursing facility (SNF) (17.1% vs. 8.6%) and need for home health care (HHC) was significantly higher in the study cohort. Complications like septicemia, septic shock, and acute kidney injury were also higher in the study group (Table 2). Table 1 Baseline demographics of the cohort Characteristics Acute pancreatitis with High HES Frailty score (> 5, intermediate + high) Acute pancreatitis with low HES Frailty score (< 5) P-value N = 1,267,744 N = 728,953 (57.5%) N = 538,781 (42.5%) Age  Mean years (Mean ± SD) 64.8 ± 12.6 58.6 ± 9.5 < 0.001 Gender < 0.001  Male 59.1% 52.3%  Female 40.9% 47.7% *Missing-475 Age groups < 0.001  18-44 3.7% 14.3%  45-64 48% 52.9%  65-84 32.2% 28.7%  ≥ 85 16.1% 4.1% Race < 0.001  Caucasians 67.4% 61.9%  African Americans 9.6% 16.8%  Others 23% 21.3% *Missing-10 Insurance type < 0.001  Medicare 40.9% 36.3%  Medicaid 17.2% 24.3%  Private 31.8% 27.9%  Other 9.9% 11.4% *Missing-75 Active smoking 32.7% 37.9% 0.005 Biliary Stone 36.2% 16.7% < 0.001 Admission Type < 0.001  Emergent 93.7% 94.3%  Elective 6.3% 5.7% *Missing-2880 Hospital ownership/control < 0.001  Rural 7.8% 10%  Urban nonteaching 26.3% 26.6%  Urban teaching 65.9% 63.4% Table 2 Outcomes Outcomes Acute pancreatitis with High HES Frailty score (> 5, intermediate + high) Acute pancreatitis with low HES Frailty score (< 5) P-value In-hospital mortality *Missing-920 4.3% 2.5% < .0001 1.72(1.65-1.80) < .0001 Length of stay, days (Median,IQR) 6(3-8) 4(2-6) < .0001 Total hospitalization cost, $ (Median,IQR) 14,412(8843-20,216) 10,193(6840-13,842) < .0001 In-Hospital Complications  ARDS 0.4% 0.3% 0.08  Ventilator dependence respiratory failure 0.23% 0.29% 0.25  Septicemia 15.2% 9.6% < .0001  Septic Shock 6.1% 2.9% < .0001  AKI 24.8% 14.9% < .0001 Disposition < .0001  Discharge to home 58.9% 74.9%  Transfer other: includes  Skilled Nursing Facility (SNF), Intermediate Care Facility (ICF), and another type of facility 17.1% 8.6%  Home health care 11.5% 8.1%  Against medical advice (AMA) 1.6% 3.4% *Missing-920 CONCLUSION: Using frailty as a construct to identify those who are at greater risk for adverse outcomes, can help formulate interventions to target individualized reversible factors to improve outcomes in patients with acute pancreatitis. Future large-scale prospective studies are warranted to understand the dynamic and longitudinal relationship between pancreatitis and frailty.

Cost-effectiveness of endoscopic, surgical and pharmacological obesity therapies: a microsimulation and threshold analyses.

OBJECTIVE: Weight loss interventions to treat obesity include sleeve gastrectomy (SG), lifestyle intervention (LI), endoscopic sleeve gastroplasty (ESG) and semaglutide. We aimed to identify which treatments are cost-effective and identify requirements for semaglutide to be cost-effective. DESIGN: We developed a semi-Markov microsimulation model to compare the effectiveness of SG, ESG, semaglutide and LI for weight loss in 40 years old with class I/II/III obesity. Extensive one-way sensitivity and threshold analysis were performed to vary cost of treatment strategies and semaglutide adherence rate. Outcome measures were incremental cost-effectiveness ratios (ICERs), with a willingness-to-pay threshold of US$100 000/quality-adjusted life-year (QALY). RESULTS: When strategies were compared with each other, ESG was cost-effective in class I obesity (US$4105/QALY). SG was cost-effective in class II obesity (US$5883/QALY) and class III obesity (US$7821/QALY). In class I/II/III, obesity, SG and ESG were cost-effective compared with LI. However, semaglutide was not cost-effective compared with LI for class I/II/III obesity (ICER US$508 414/QALY, US$420 483/QALY and US$350 637/QALY). For semaglutide to be cost-effective compared with LI, it would have to cost less than US$7462 (class III), US$5847 (class II) or US$5149 (class I) annually. For semaglutide to be cost-effective when compared with ESG, it would have to cost less than US$1879 (class III), US$1204 (class II) or US$297 (class I) annually. CONCLUSIONS: Cost-effective strategies were: ESG for class I obesity and SG for class II/III obesity. Semaglutide may be cost-effective with substantial cost reduction. Given potentially higher utilisation rates with pharmacotherapy, semaglutide may provide the largest reduction in obesity-related mortality.

Fully Covered Self-expanding Stents are Cost-effective at Remediating Biliary Strictures in Patients With Chronic Pancreatitis.

Benign biliary strictures (BBS) develop in up to 10% to 30% of patients with chronic pancreatitis (CP).1 Endoscopic endoprosthetics via endoscopic retrograde cholangiopancreatography (ERCP) has become the standard of care for remediating these strictures. Seventy percent to eighty percent of these strictures resolve with sequential or concurrent placement of multiple plastic stents (MPS).1,2 More recently, placement of fully covered self-expanding metal stents (FCSEMS) have been shown to have similar outcomes as MPS.3-6 FCSEMS provide a larger radial diameter and require fewer procedures, but may have drawbacks, including a higher risk of migration, cholecystitis, delamination, and tissue ingrowth. A recent study demonstrated that FCSEMS with a 12-month indwell had similar outcomes to MPS with fewer ERCP needed.7 However, the cost-effectiveness of either strategy for managing BBS has not been assessed previously nor has the impact of additional reimbursement to cover the cost of FCSEMS on the cost-effectiveness of FCSEMS utilization.

A Cost-Effectiveness Analysis for Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis Prophylaxis in the United States.

BACKGROUND & AIMS: Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is the most common adverse event after endoscopic retrograde cholangiopancreatography, and is responsible for substantial morbidity and health care expenditures of at least $200 million. Therapies for PEP prevention include pancreatic stent placement (PSP), rectal indomethacin, sublingual nitrates, and aggressive lactated Ringer's hydration. Our objective was to determine which PEP prophylactic strategies are cost effective. METHODS: We developed 2 separate decision trees to evaluate PEP prophylactic strategies. The first, in high-risk patients, compared rectal indomethacin, PSP, PSP with indomethacin, sublingual nitrates, aggressive hydration with lactated Ringer's, and no prophylaxis. The second, in average-risk patients, compared rectal indomethacin, sublingual nitrates, aggressive hydration, and no prophylaxis. We used incidence rates, transition probabilities, and costs from publications and public data sources. Outcome measures were reported as incremental cost-effectiveness ratios, with a willingness-to-pay (WTP) threshold of $100,000/quality-adjusted life years (QALYs). RESULTS: Compared with no prophylaxis, all strategies were cost effective at a WTP of $100,000 in preventing PEP in high-risk patients. When directly compared with each other, rectal indomethacin was the cost-effective strategy in high-risk patients ($31,589/QALYs). In average-risk patients, indomethacin and sublingual nitrates were cost effective at a WTP of $100,000/QALYs compared with no prophylaxis. When directly compared with each other, rectal indomethacin was the cost-effective strategy ($53,016/QALYs). CONCLUSIONS: Rectal indomethacin was the cost-effective strategy for preventing PEP in both average-risk and high-risk patients undergoing endoscopic retrograde cholangiopancreatography. All strategies were cost effective when compared with no prophylaxis in high-risk patients, whereas all strategies except for aggressive hydration with lactated Ringer's were cost effective in average-risk patients. Further studies are needed to improve the utilization of PEP prevention strategies.

Biosimilars in Inflammatory Bowel Disease.

Over the past 2 decades, biological therapy with monoclonal antibodies targeting tumor necrosis factor-α has become a cornerstone of treatment of patients with inflammatory bowel disease. Although clinically effective, the biological therapies remain expensive, and their availability and utilization have been at times limited due to their high costs. Biosimilars are biological products similar to but not identical to the original biological agent or "reference biologic," also called "originator biologic." It is hoped that the use of biosimilars might enable these agents to become more available and, thus, decrease further expenditures related to the use of the original reference agents such as infliximab and adalimumab. In this study, we review the currently available evidence and shortcomings of these data supporting the use of biosimilars for the treatment of patients with inflammatory bowel disease, including their efficacy and safety as related to initiating therapy with biosimilar agents or switching between reference and biosimilar biologic agents.

P065 A One-Time Education for Gastroenterologists Regarding Osteoporosis Screening for IBD Patients Improves Provider Knowledge But Not Screening Rates.

BACKGROUND: Inflammatory Bowel Disease (IBD) is a chronic gastrointestinal inflammatory condition and has been increasing in prevalence in the United States, with a 30-40% increase over the past few decades. Osteoporosis can be seen in up to 40% of IBD patients. Screening for osteoporosis in IBD patients involves the use of DEXA scans and is recommended by the IBD Cornerstone Committee for select patients, including steroid use > 3 months consecutively or a total of 1 year in the past 2 years, family history of osteoporosis, malnutrition, amenorrheic or post-menopausal. Our quality improvement study looked to improve osteoporosis screening among gastroenterologists. METHODS: We conducted a retrospective chart review on all IBD patients within the St. Luke's Network and extrapolated data on age (>50 in male and >65 in female), sex, chronic glucocorticoid use (3 month consecutively or cumulative), osteoporosis/osteopenia diagnosis, vitamin D (vit-D) levels, and DEXA scan between 2019 to 2021. We gave a 5-minute presentation on current DEXA screen recommendations for patients with IBD on 5/27/2021 to all the network's gastroenterologists, which totaled 12. We performed a pre and post education survey consisting of 5 questions on provider knowledge and comfortability with osteoporosis screening. We assessed provider knowledge, as well as rates of osteoporosis screening. All statistical analyses were conducted in IBM SPSS for Windows Version 26. Chi Square tests were used to compare two groups in categorical variables while Mann-Whitney tests were done to compare continuous variables like age and vit-D levels. RESULTS: There were a total of 5442 patients; 3927 patients before the educational intervention on 5/27/2021 and 1515 patients after the intervention. Both pre and post intervention groups were balanced in terms of age, gender, smoking status, and alcohol risk. Percent of DEXA scans were similar between both groups (13.0% vs 12.3%, p=0.5). DEXA screening rates among patients with chronic steroid use pre-intervention vs post-intervention was 44.45 vs 42.4% respectively. Vit-D levels compared between both groups was not statistically significant (30.5 vs 31.8, p=0.1). Surveys conducted before and after the intervention showed an overall increase in percentage of agreement responses about knowledge and confidence in DEXA screening (88.5% vs 97.5%). CONCLUSION: DEXA scanning can help detect premature decrease in bone mineral density and provide physicians with the opportunity to prevent further morbidity. Our study showed no difference in DEXA screening rates before and after intervention. However, there was an increase in provider knowledge based on post-intervention surveys. A similar study showed that it took three interventions, including educational presentation, flyers, and on screen EMR reminders for there to be a sustainable improvement in the rate of DEXA screening. Our project may have required additional interventions to produce an effect and thus reinforces the need for further efforts to improve osteoporosis screening in IBD patients.

Colonic diverticular disease in autosomal dominant polycystic kidney disease: is there really an association? A nationwide analysis.

PURPOSE: Colonic diverticulosis, diverticulitis, and diverticular bleeding are reportedly more common in patients with autosomal dominant polycystic kidney disease (ADPKD). Other studies have questioned this association. The objectives of our study are to clarify this association using a larger patient population and to identify risk factors in general to develop diverticular disease. METHODS: The Nationwide Inpatient Sample weighted discharges from 2003 to 2011 were used to assess for the prevalence of diverticular disease in the population with ADPKD compared with the general population without ADPKD. A multivariable direct logistic regression model was constructed to determine independent predictors of diverticular disease in the general population. RESULTS: The prevalence of diverticulosis, diverticulitis, and diverticular bleeding were considerably increased in patients with ADPKD compared with the general population without ADPKD. The prevalence of colonic surgery was less in ADPKD patients with diverticulitis. In patients with kidney transplant, the prevalence of diverticulitis was increased in the ADPKD group, but colonic surgery was not significantly different between both groups. The prevalence of diverticular bleeding was slightly elevated in patients with ADPKD, but colonic surgery was significantly increased in patients with ADPKD. NSAID use, hypertension, constipation, and ADPKD had increased odds ratios for diverticular disease during multivariate analysis. CONCLUSION: There is an increased prevalence of colonic diverticular disease in the population with ADPKD.

Cost Effectiveness of Gastric Cancer Screening According to Race and Ethnicity.

BACKGROUND & AIMS: There are marked racial and ethnic differences in non-cardia gastric cancer prevalence within the United States. Although gastric cancer screening is recommended in some regions of high prevalence, screening is not routinely performed in the United States. Our objective was to determine whether selected non-cardia gastric cancer screening for high-risk races and ethnicities within the United States is cost effective. METHODS: We developed a decision analytic Markov model with the base case of a 50-year-old person of non-Hispanic white, non-Hispanic black, Hispanic, or Asian race or ethnicity. The cost effectiveness of a no-screening strategy (current standard) for non-cardia gastric cancer was compared with that of 2 endoscopic screening modalities initiated at the time of screening colonoscopy for colorectal cancer: upper esophagogastroduodenoscopy with biopsy examinations and continued surveillance only if intestinal metaplasia or more severe pathology is identified or esophagogastroduodenoscopy with biopsy examinations continued every 2 years even in the absence of identified pathology. We used prevalence rates, transition probabilities, costs, and quality-adjusted life years (QALYs) from publications and public data sources. Outcome measures were reported in incremental cost-effectiveness ratios, with a willingness-to-pay threshold of $100,000/QALY. RESULTS: Compared with biennial and no screening, screening esophagogastroduodenoscopy with continued surveillance only when indicated was cost effective for non-Hispanic blacks ($80,278/QALY), Hispanics ($76,070/QALY), and Asians ($71,451/QALY), but not for non-Hispanic whites ($122,428/QALY). The model was sensitive to intestinal metaplasia prevalence, transition rates from intestinal metaplasia to dysplasia to local and regional cancer, cost of endoscopy, and cost of resection (endoscopic or surgical). CONCLUSIONS: Based on a decision analytic Markov model, endoscopic non-cardia gastric cancer screening for high-risk races and ethnicities could be cost effective in the United States.

Delays in Initiating Post-operative Prophylactic Biologic Therapy Are Common Among Crohn's Disease Patients.

BACKGROUND: Studies have shown that prophylactic biologic therapy can reduce post-surgical Crohn's disease recurrence. AIMS: We aimed to identify the frequency of delay and risk factors associated with a delay in the initiation of prophylactic post-surgical biologic therapy in high-risk patients. METHODS: We performed a cohort study of Crohn's disease patients who underwent a bowel resection. We identified those at risk of recurrence and explored multiple characteristics for those with and without a delay post-operatively. RESULTS: A total of 84 patients were included in our analysis of which 69.0% had a greater than 4-week delay and 56.0% a greater than 8-week delay in post-surgical biologic prophylaxis. Publicly insured patients had a 100% delay in post-surgical prophylaxis initiation (p = 0.039, p = 0.003 at 4 and 8 weeks, respectively). Patients on a biologic pre-surgery were less likely to have a delay (p < 0.001) in post-operative prophylaxis. Care at an inflammatory bowel disease (IBD) center was associated with timely therapy when considering a post-operative immunomodulator or biologic strategy. CONCLUSIONS: There are a substantial number of delays in initiating post-operative prophylactic biologic therapy in high-risk patients. Identifying susceptible patients by insurance type or absence of pre-operative therapy can focus future improvement efforts. Additionally, consultation with IBD-specialized providers should be considered in peri-surgical IBD care.

Risk of Early Colorectal Cancers Needs to Be Considered in Inflammatory Bowel Disease Care.

BACKGROUND: Current guidelines recommend starting colorectal cancer (CRC) surveillance 8-10 years after inflammatory bowel disease (IBD) onset. Recent studies report that the incidence of CRC within 8-10 years of IBD onset (i.e., early CRC) ranges from 12 to 42%. AIMS: To describe the current prevalence of early CRC in a tertiary care center IBD cohort with CRC and to identify associated risk factors. METHODS: We performed a single-center observational study of IBD patients diagnosed with CRC from 2005 to 2015. We compared characteristics of patients with early CRC (diagnosis of CRC within 8 years of initial IBD onset) to those with CRC diagnosed later in their IBD course. RESULTS: Ninety-three patients met inclusion criteria. Eleven (11.8%) patients developed CRC within 8 years of initial IBD onset. On multivariable logistic regression, age greater than 28 at IBD onset (adjusted OR 12.0; 95% CI 2.30, 62.75) and tobacco use (adjusted OR 8.52; 95% CI 1.38, 52.82) were significant predictors of early CRC. A validation cohort confirmed calibration and discrimination of the model. CONCLUSIONS: One out of every eight IBD patients with CRC developed their malignancy prior to the currently recommended timeframe for the initiation of surveillance colonoscopy. IBD onset at 28 years or older and tobacco use were identified as predictors of early CRC. Early CRC should be considered in discussions of cancer surveillance in this population. Prospective cohort studies are necessary to further analyze the impact of early CRC in IBD.

Cost Effectiveness of Early Insertion of Transjugular Intrahepatic Portosystemic Shunts for Recurrent Ascites.

BACKGROUND & AIMS: Treatment options for recurrent ascites resulting from decompensated cirrhosis include serial large-volume paracentesis and albumin infusion (LVP+A) or insertion of a transjugular intrahepatic portosystemic shunt (TIPS). Insertion of TIPSs with covered stents during early stages of ascites (early TIPS, defined as 2 LVPs within the past 3 weeks and <6 LVPs in the prior 3 months) significantly improves chances of survival and reduces complications of cirrhosis compared with LVP+A. However, it is not clear if TIPS insertion is cost effective in these patients. METHODS: We developed a Markov model using the payer perspective for a hypothetical cohort of patients with cirrhosis with recurrent ascites receiving early TIPSs or LVP+A using data from publications and national databases collected from 2012 to 2018. Projected outcomes included quality-adjusted life-year (QALY), costs (2017 US dollars), and incremental cost-effectiveness ratios (ICERs; $/QALY). Sensitivity analyses (1-way, 2-way, and probabilistic) were conducted. ICERs less than $100,000 per QALY were considered cost effective. RESULTS: In base-case analysis, early insertion of TIPS had a higher cost ($22,770) than LVP+A ($19,180), but also increased QALY (0.73 for early TIPSs and 0.65 for LVP+A), resulting in an ICER of $46,310/QALY. Results were sensitive to cost of uncomplicated TIPS insertion and transplant, need for LVP+A, probability of transplant, and decompensated QALY. In probabilistic sensitivity analysis, TIPS insertion was the optimal strategy in 59.1% of simulations. CONCLUSIONS: Based on Markov model analysis, early placement of TIPSs appears to be a cost-effective strategy for management of specific patients with cirrhosis and recurrent ascites. TIPS placement should be considered early and as a first-line treatment option for select patients.

A single-operator learning curve analysis for the endoscopic sleeve gastroplasty.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is a novel, incisionless technique for gastric volume reduction to promote weight loss. Our aim was to describe the learning curve for performing ESG using a prospective case series. METHODS: Using a prospective case series design, we analyzed the first 128 consecutive patients at a tertiary care academic medical center who underwent ESG performed by a single operator from August 2013 to December 2016. Efficiency (refining performance to decrease procedure time) and mastery (absence of outliers) for performing ESG was evaluated by using a penalized basis-spline regression and cumulative sum analysis. RESULTS: Efficiency for ESG was attained after 38 ESGs, with mastery after 55 procedures. At 12 months, the mean percent total body weight loss was 15.8% (standard deviation, 9.47%). A total of 71.7% of patients achieved successful weight loss. When using multiple linear regression analysis, both number of sutures and baseline weight were significantly associated with procedure time. Other patient characteristics, such as age, sex, and race, did not significantly affect procedure time. In addition, number of sutures, baseline weight, and endoscopist achieving efficiency were not correlated with successful weight loss at 12 months. CONCLUSIONS: Mastery of ESG by a single operator is suggested after sufficient endoscopic experience and may help guide widespread clinical adaptability.

Discharge Disposition After Stroke in Patients With Liver Disease.

BACKGROUND AND PURPOSE: Liver disease is associated with both hemorrhagic and thrombotic processes, including an elevated risk of intracranial hemorrhage. We sought to assess the relationship between liver disease and outcomes after stroke, as measured by discharge disposition. METHODS: Using administrative claims data, we identified a cohort of patients hospitalized with stroke in California, Florida, and New York from 2005 to 2013. The predictor variable was liver disease. All diagnoses were defined using validated diagnosis codes. Ordinal logistic regression was used to analyze the association between liver disease and worsening discharge disposition: home, nursing/rehabilitation facility, or death. Secondarily, multiple logistic regression was used to analyze the association between liver disease and in-hospital mortality. Models were adjusted for demographics, vascular risk factors, and comorbidities. RESULTS: We identified 121 428 patients with intracerebral hemorrhage and 703 918 with ischemic stroke. Liver disease was documented in 13 584 patients (1.7%). Liver disease was associated with worse discharge disposition after both intracerebral hemorrhage (global odds ratio, 1.28; 95% confidence interval, 1.19-1.38) and ischemic stroke (odds ratio, 1.23; 95% confidence interval, 1.17-1.29). Similarly, liver disease was associated with in-hospital death after both intracerebral hemorrhage (odds ratio, 1.33; 95% confidence interval, 1.23-1.44) and ischemic stroke (odds ratio, 1.60; 95% confidence interval, 1.51-1.71). CONCLUSIONS: Liver disease was associated with worse hospital discharge disposition and in-hospital mortality after stroke, suggesting worse functional outcomes.

Optical coherence tomography (OCT) prior to peroral endoscopic myotomy (POEM) reduces procedural time and bleeding: a multicenter international collaborative study.

BACKGROUND: Per-oral endoscopic myotomy (POEM) has emerged as an endoscopic treatment of achalasia. There are no pre-procedural imaging modalities to predict the safest and the most efficacious approach. AIM: To evaluate the use of optimal coherence tomography (OCT) in providing a pre-procedural esophageal assessment. METHODS: Patients undergoing POEM from July 2013 to November 2015 were captured in a multicenter, international registry. Patients who underwent OCT pre-POEM ("OCT arm") were compared to patients without pre-POEM OCT ("control arm"). OCT images were assessed for the degree of vascularity and the thickness of the circular muscular layer, and an approach was determined. RESULTS: A total of 84 patients were captured in the registry. Fifty-one patients underwent pre-POEM OCT. Using OCT as a guide, 24 (47 %) of patients underwent anterior POEM while 27 (53 %) underwent posterior POEM. Technical success was achieved in 96 % of patients. Significantly less bleeding occurred in the OCT arm when compared to the control group [4 (8 %) vs. 14 (43 %), p = 0.0001]. As a result, procedural time was significantly lower in the OCT group as compared to the control group (85.8 vs. 121.7 min, p = 0.000097). CONCLUSION: Pre-POEM OCT results in a reduction in procedural bleeding which contributes to a reduction in overall procedural time. CLINICAL TRIAL REGISTRATION: NCT01438385.