Trends in Textbook Outcomes over Time: Are Optimal Outcomes Following Complex Gastrointestinal Surgery for Cancer Increasing?

BACKGROUND: The use of composite measures like "textbook outcome" (TO) may provide a more accurate measure of surgical quality. We sought to determine if TO has improved over time and to characterize the association of achieving a TO with trends in survival among patients undergoing complex gastrointestinal surgery for cancer. METHODS: Medicare beneficiaries who underwent pancreas, liver, or colon resection for a cancer diagnosis between 2004 and 2016 were identified using the SEER-Medicare database. Rates of TO (no complication, extended length of stay, 90-day readmission, or 90-day mortality) were assessed over time. RESULTS: Among 94,329 patients, 6765 (7.2%), 1985 (2.1%), and 85,579 (90.7%) patients underwent resection for primary pancreatic, hepatic, or colon cancer, respectively. In total, 53,464 (56.7%) patients achieved a TO; achievement of TO varied by procedure (pancreatectomy: 48.1% vs. hepatectomy: 55.2% vs. colectomy: 57.4%, p < 0.001). The proportion of patients achieving a textbook outcome increased over time for all patients (2004-2007, 53.3% vs. 2008-2011, 56.5% vs. 2012-2016, 60.1%) (5-year increase: OR 1.16 95%CI 1.13-1.18) (p < 0.001). Survival at 1-year following pancreatic, liver, or colon resection for cancer had improved over time among both patients who did and did not achieve a postoperative TO. TO was independently associated with a marked reduction in hazard of death (HR 0.44, 95%CI 0.43-0.45). The association of TO and survival was consistent among patients stratified by procedure. CONCLUSION: Less than two-thirds of patients undergoing complex gastrointestinal surgery for a malignant indication achieved a TO. The likelihood of achieving a TO increased over time and was associated with improved survival.

Women in Surgery Italia: National Survey Assessing Gender-Related Challenges.

BACKGROUND: In 2019, women accounted for 46% of surgical residents. Despite the international debate on gender disparities, no literature regarding the experience in Italy is available. The aim of this survey study was to assess satisfaction among female surgeons in Italy, and determine whether they encounter gender-based discrimination. STUDY DESIGN: An anonymous, 83-item web-based survey was distributed among female surgeons working in Italy, from November 18 to December 31, 2020. Gender equity, satisfaction, and factors associated with higher satisfaction and work-life balance were explored. RESULTS: There were 3,242 volunteer respondents, 1,833 of whom completed at least 50% of the specific questions and were included in the study. Approximately 54% of female Italian surgeons reported being satisfied with their job, but only 34% with their work-life balance. Among residents, 67% thought they were not adequately trained. The majority of respondents were responsible for most of the housekeeping (60%) and childcare duties (53%), regardless of their partner's workload, and 62% reported that gender affects the way they are treated at work, with most of them experiencing microaggressions. Sexual harassment was common (59%), but only 10% of women reported it. CONCLUSIONS: Most Italian female surgeons are satisfied with their professional choice. However, they face gender discrimination, including incidents of sexual harassment and microaggression. Due to the fact that half of surgeons working in Italian hospitals will be females in the next few years, actions are urgently required to build a culture that supports a gender-neutral environment.

Long-term outcomes after resection of alcohol-related versus hepatitis-related hepatocellular carcinoma: A SEER-Medicare database analysis.

BACKGROUND: The objective of this study was to define the relative impact of alcohol and/or hepatitis-related HCC etiology on the outcomes of patients who underwent resection or transplantation for HCC. METHODS: The SEER-Medicare database was used to identify patients with HCC between 2004 and 2015. Patients with history of alcohol abuse or hepatitis were identified. Overall survival (OS) and cancer-specific survival (CSS) were calculated using the Kaplan-Meier method and multivariable Cox regression analysis. RESULTS: Among 1140 patients, 11.9% (n = 136) of patients had alcohol-related HCC, 30.0% (n = 342) hepatitis-related HCC, and 58.1% (n = 662) had other cause-related HCC. On multivariable analysis, patients with alcohol-related HCC (HR:1.06, 95%CI:0.82-1.35) or hepatitis-related HCC (HR:1.05, 95%CI:0.88-1.26) had similar hazards of death compared with patients who had non-alcohol/non-hepatitis-related HCC. Patients who had tumor size ≤5 cm had lower hazards of death (HR:0.81, 95%CI:0.68-0.97), while individuals who underwent liver resection (vs. transplantation) had almost a two-fold higher hazards of death (HR:1.99, 95%CI:1.47-2.69). CONCLUSION: Tumor specific factors (i.e. tumor size and stage) and operative approach (i.e. resection vs. transplantation) -rather than HCC etiology- dictated both OS and CSS.

Gastrointestinal coronavirus disease 2019: epidemiology, clinical features, pathogenesis, prevention, and management.

INTRODUCTION: The new Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is the etiologic agent of coronavirus disease 2019. Some authors reported pieces of evidence that patients with SARS-CoV-2 infection could have direct involvement of the gastrointestinal tract, and in symptomatic cases, gastrointestinal symptoms (diarrhea, nausea/vomiting, abdominal pain) could be very common. AREA COVERED: In this article, we reviewed current-published data of the gastrointestinal aspects involved in SARS-CoV-2 infection, including prevalence and incidence of specific symptoms, the presumptive biological mechanism of GI infection, prognosis, clinical management, and public health-related concerns on the possible risk of oral-fecal transmission. EXPERT OPINION: Different clues point to direct virus infection and replication in mucosal cells of the gastrointestinal tract. In vitro studies showed that SARS-CoV-2 could enter into the gastrointestinal epithelial cells by the Angiotensin-Converting enzyme two membrane receptor. These findings, coupled with the identification of viral RNA found in stools of patients, clearly suggest that direct involvement of the gastrointestinal tract is very likely. This can justify most of the gastrointestinal symptoms but also suggest a risk for an oral-fecal route for transmission, additionally or alternatively to the main respiratory route.

Specific Medicare Severity-Diagnosis Related Group Codes Increase the Predictability of 30-Day Unplanned Hospital Readmission After Pancreaticoduodenectomy.

BACKGROUND: The Medicare Severity-Diagnosis Related Group coding system (MS-DRG) is routinely used by hospitals for reimbursement purposes following pancreatic surgery. We aimed to determine whether specific pancreatectomy MS-DRG codes, when combined with distinct clinicopathologic and perioperative characteristics, increased the accuracy of predicting 30-day readmission after pancreaticoduodenectomy (PD). METHODS: Demographic, clinicopathologic, and perioperative factors were compared between readmitted and non-readmitted patients at Brigham and Women's Hospital following PD. Different pancreatectomy DRG codes, currently used for reimbursement purposes [407: without complication/co-morbidity (CC), 406: with CC, and 405: with major CC] were combined with clinical factors to assess their predictability of readmission. Univariate and multivariable analyses were performed to evaluate outcomes. RESULTS: Among 354 patients who underwent PD between 2010 and 2017, 69 (19%) were readmitted. The incidence of readmission was 13, 32, and 55% for patients with assigned DRG codes 407, 406, and 405, respectively (P = 0.0395). Readmitted patients were more likely to have had T4 disease (P = 0.0007), a vascular resection (P = 0.0078), and longer operative times (P = 0.012). On multivariable analysis, combining DRG 407 with relevant clinicopathologic factors was unable to predict readmission. In contrast, DRG 406 code among patients with N positive disease (P = 0.0263) and LOS > 10 days (P = 0.0505) was associated with readmission. DRG 405, preoperative obstructive jaundice (OR: 7.5, CI: 1.5-36, P = 0.0130), vascular resection (OR: 7.7, CI: 1.1-51, P = 0.0336), N positive stage of disease (OR: 0.2, CI: 0-0.9, P = 0.0447), and operative time > 410 min (OR: 5.9, CI: 1-32, P = 0.0399) were each strongly associated with 30-day readmission after PD [likelihood ratio (LR) < 0.0001]. CONCLUSIONS: Distinct pancreatectomy MS-DRG classification codes (405), combined with relevant clinicopathologic and perioperative characteristics, strongly predicted 30-day readmission after PD. DRG classification algorithms can be implemented to more accurately identify patients at a higher risk of readmission.

Assessment of the Lymph Node Status in Patients Undergoing Liver Resection for Intrahepatic Cholangiocarcinoma: the New Eighth Edition AJCC Staging System.

INTRODUCTION: The role of routine lymphadenectomy for intrahepatic cholangiocarcinoma (ICC) is still controversial. The AJCC eighth edition recommends a minimum of six harvested lymph nodes (HLNs) for adequate nodal staging. We sought to define outcome and risk of death among patients who were staged with ≥6 HLNs versus <6 HLNs. MATERIALS AND METHODS: Patients undergoing hepatectomy for ICC between 1990 and 2015 at 1 of the 14 major hepatobiliary centers were identified. RESULTS: Among 1154 patients undergoing hepatectomy for ICC, 515 (44.6%) had lymphadenectomy. On final pathology, 200 (17.3%) patients had metastatic lymph node (MLN), while 315 (27.3%) had negative lymph node (NLN). Among NLN patients, HLN was associated with 5-year OS (p = 0.098). While HLN did not impact 5-year OS among MLN patients (p = 0.71), the number of MLN was associated with 5-year OS (p = 0.02). Among the 317 (27.5%) patients staged according the AJCC eighth edition staging system, N1 patients had a 3-fold increased risk of death compared with N0 patients (hazard ratio 3.03; p < 0.001). CONCLUSION: Only one fourth of patients undergoing hepatectomy for ICC had adequate nodal staging according to the AJCC eighth edition. While the six HLN cutoff value impacted prognosis of N0 patients, the number of MLN rather than HLN was associated with long-term survival of N1 patients.

Liver Resection for Breast Cancer Liver Metastases: A Cost-utility Analysis.

OBJECTIVE: To estimate the cost-effectiveness of liver resection followed by adjuvant systemic therapy relative to systemic therapy alone for patients with breast cancer liver metastasis. BACKGROUND: Data on cost-effectiveness of liver resection for advanced breast cancer with liver metastasis are lacking. METHODS: A decision-analytic Markov model was constructed to evaluate the cost-effectiveness of liver resection followed by postoperative conventional systemic therapy (strategy A) versus conventional therapy alone (strategy B) versus newer targeted therapy alone (strategy C). The implications of using different chemotherapeutic regimens based on estrogen receptor and human epidermal growth factor receptor 2 status was also assessed. Outcomes included quality-adjusted life months (QALMs), incremental cost-effectiveness ratio, and net health benefit (NHB). RESULTS: NHB of strategy A was 10.9 QALMs compared with strategy B when letrozole was used as systemic therapy, whereas it was only 0.3 QALMs when docetaxel + trastuzumab was used as a systemic therapy. The addition of newer biological agents (strategy C) significantly decreased the cost-effectiveness of strategy B (conventional systemic therapy alone). The NHB of strategy A was 31.6 QALMs versus strategy C when palbociclib was included in strategy C; similarly, strategy A had a NHB of 13.8 QALMs versus strategy C when pertuzumab was included in strategy C. Monte-Carlo simulation demonstrated that the main factor influencing NHB of strategy A over strategy C was the cost of systemic therapy. CONCLUSIONS: Liver resection in patients with breast cancer liver metastasis proved to be cost-effective when compared with systemic therapy alone, particularly in estrogen receptor-positive tumors or when newer agents were used.

Racial disparities in treatment and survival of patients with hepatocellular carcinoma in the United States.

BACKGROUND: While the incidence and mortality of hepatocellular carcinoma (HCC) continue to increase across the United States (US), disparities may exist relative to treatment modality and survival. The objective of the present study was to determine the factors associated with racial differences in survival among patients with HCC in the US. METHODS: The Surveillance, Epidemiology, and End Results (SEER) database was used to identify patients with HCC between 1998 and 2012 in the US. Multivariable logistic regression analysis was performed to examine associations between type of therapy and race, while a multivariable Cox proportional hazards model was built to determine the effect of race on survival. RESULTS: A total of 58,186 patients with HCC were identified. Over two-thirds of patients were white (n=39,223, 67.4%), while 18.3% were Asian (n=10,665), 13.1% black (n=7,620) and 1.2% native American (n=678). In comparison to other racial groups, Asian patients with HCC tended to be older [white vs. black vs. native American vs. Asian: median age: 63 years, interquartile range (IQR), 55-73 vs. 59 years, IQR, 53-66 vs. 59 years, IQR, 53-69 vs. 64 years, IQR, 55-73, P<0.001] and were diagnosed with larger tumors (white vs. black vs. native American vs. Asian: median tumor size: 4.8 cm, IQR, 3.0-8.0 vs. 5.1 cm, IQR, 3.1-8.7 vs. 4.8 cm, IQR, 3.0-7.3 vs. 5.5 cm, IQR, 3.1-9.0, P<0.001). Asian patients were also less likely to present with concomitant cirrhosis (white vs. black vs. native American vs. Asian: 81.8% vs. 77.7% vs. 83.2% vs. 69.1%, P<0.001) while elevated levels of alpha-fetoprotein more were often noted among black patients (white vs. black vs. native American vs. Asian: 25.5% vs. 14.9% vs. 22.2% vs. 21.8%, P<0.001). Compared to other racial groups, Asian patients were most likely to receive any form of treatment (white vs. black vs. native American vs. Asian: 29.2% vs. 25.2% vs. 27.6% vs. 34.4%, P<0.001). In particular, after controlling for potential confounders, Asian patients demonstrated the greatest odds of undergoing surgery (OR: 1.48, 95% CI, 1.13-1.95, P=0.01). The median overall survival (OS) was 11 months with the worst prognosis noted among black patients. After accounting for disease and patient factors, Asian patients demonstrated the lowest risk for death [hazard ratio (HR): 0.76, 95% CI, 0.66-0.87, P<0.001] while no differences were noted in the risk of death among other racial groups (all P>0.05). CONCLUSIONS: Significant racial differences were noted in presentation, treatment and survival among patients with HCC. Further research is necessary to better understand socio-demographic and biological factors driving racial disparities in care. Future policies should aim to improve access to care among racial/ethnic minorities.

Factors Associated With Interhospital Variability in Inpatient Costs of Liver and Pancreatic Resections.

IMPORTANCE: In an era of accountable care, understanding variation in health care costs is critical to reducing health care spending. OBJECTIVE: To identify factors associated with increased hospital costs and quantify variations in costs among individual hospitals in patients undergoing liver and pancreatic surgery in the United States. DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of total costs among 42 480 patients undergoing hepatopancreaticobiliary surgery from January 1, 2002, through December 31, 2011, using a nationally representative data set (Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project). Analysis was conducted in May 2015. MAIN OUTCOMES AND MEASURES: Total inpatient costs and proportional variation in inpatient costs among individual hospitals. RESULTS: Among the 42 480 patients who underwent liver or pancreatic resection, the median age was 62 years, 52.4% were female, and 72.9% had a Charlson Comorbidity Index of 2 or higher. The median cost for the entire cohort was $21,535 (interquartile range, $15,373-$31,104), varying from $3320 to $279,102 among individual hospitals. On multivariable analysis, increasing patient comorbidity (coefficient, 2000.30; 95% CI, 1363.33-2637.27; P < .001) and operative characteristics (total pancreatectomy: coefficient, 12 742.31; 95% CI, 10 063.66-15 420.94; P < .001; lobectomy: coefficient, 6336.42; 95% CI, 3934.61-8737.24; P < .001) were associated with higher hospital costs. The development of postoperative complications, such as sepsis (coefficient, 30 571.25; 95% CI, 29 308.96-31 833.54; P < .001) or stroke (coefficient, 8925.34; 95% CI, 2801.38-15 049.30; P = .004), and a longer length of stay were most strongly predictive of higher inpatient cost (length of stay >14 days: coefficient, 44 162.24; 95% CI, 43 125.56-45 198.92; P < .001). After adjusting for patient and hospital characteristics, the overall cost of hepatopancreaticobiliary surgery varied by $9000 among individual hospitals. CONCLUSIONS AND RELEVANCE: Significant variability was noted in hospital costs among patients undergoing pancreatic and liver surgery. Future policies should focus on reducing variations in costs by promoting payment paradigms that support a better quality of care and lower costs.

Understanding drivers of hospital charge variation for episodes of care among patients undergoing hepatopancreatobiliary surgery.

BACKGROUND: Understanding factors associated with variation in hospital charges may help identify means to increase savings. The aim of the present study was to define potential variation in hospital charges associated with hepatopancreatobiliary(HPB) surgery. METHODS: Patients who underwent an HPB procedure between 2009-2013 were identified. Total hospital charges were tabulated for room and board, surgical/anaesthesia services, medications, laboratory/radiology services and other miscellaneous charges. RESULTS: Approximately 2545 patients underwent either a pancreas (66.8%) or liver/biliary (33.2%) resection. The mean total charges for all patients were $42,357 ± 33,745 (pancreas: $46,352 ± 34,932 versus the liver: $34,303 ± 29,639; P < 0.001). Morbidity (pancreas, range: 7-18%; liver, range: 9-18%) and observed:expected (O:E) length of stay (LOS)(pancreas, range: 0.67-1.64; liver, range: 1.06-3.35) varied among providers (both P < 0.001). While a peri-operative complication resulted in increased total hospital charges (complication: $66,401 ± 55,124 versus no complication: $39,668 ± 29,250; P < 0.001), total charges remained variable even among patients who did not experience a complication (P < 0.001). Surgeons within the lowest quartile of O:E LOS had lower total charges ($33 879 ± $27 398) versus surgeons in the highest quartile ($49,498 ± 40 971) (P < 0.001). Surgeons with the highest O:E LOS had higher across-the-board charges (operating room, highest quartile: $10,514 ± $4496 versus lowest quartile: $7842 ± $3706; medication, highest quartile: $1796 ± $3799 versus lowest quartile: $925 ± $2211; radiology, highest quartile: $2494 ± $4683 versus lowest quartile: $1424 ± $3247; P = 0.001; laboratory, highest quartile: $4236 ± $5991 versus lowest quartile: $3028 ± $3804; all P < 0.001). CONCLUSIONS: After accounting for in-hospital complications, the total mean hospital charges for HPB surgery remained variable by case type and provider. While the variation in charges was associated with LOS, provider-level differences in across-the-board charges were also noted.

Early versus late readmission after surgery among patients with employer-provided health insurance.

OBJECTIVES: To define the incidence of 90-day readmission and characterize the factors associated with 90-day readmission after 10 major surgical procedures. BACKGROUND: Most data on readmission focus solely on same hospital readmission (index hospitals) within 30 days of discharge. These studies may underestimate readmission, as patients may be readmitted beyond 30 days of discharge or to other non-index hospitals. METHODS: Patients discharged after 10 major surgical procedures (coronary artery bypass grafting, abdominal aortic aneurysm repair, carotid endarterectomy, aortic valve replacement, esophagectomy, pancreatectomy, pulmonary resection, hepatectomy, colectomy, and cystectomy) between 2010 and 2012 were identified from the Truven Health MarketScan Commercial Claims and Encounters database. Multivariable logistic regression analysis was performed to identify determinants of early (≤30 days) and late (31-90 days) readmission. RESULTS: A total of 158,753 patients were identified; 60.3% were male, and 42.3% had a Charlson Comorbidity Index of 2 or more. A total of 26,817 (16.9%) patients were readmitted within 90 days [early: 16,419 (10.4%) vs late: 10,398 (6.5%)]. Among readmitted patients, 38.3% were readmitted to a different hospital than the index hospital. Both early and late readmissions were more common at the index versus non-index hospital (early: 83.9% vs 16.1%; late: 75.0% vs 25.0%; both P < 0.001). In-hospital mortality after early readmission and late readmission was found to be lower at index hospitals than that at non-index hospitals (early; 0.7% vs 2.5%, P = 0.04; late; 0.2% vs 2.0%, P = 0.02). CONCLUSIONS: More than one-third of readmission occurred after 30 days of index discharge. Approximately 20% of patients were readmitted to non-index hospitals. Assessment of 30 day same hospital readmissions underestimated the true incidence of readmission.

Utility-based criteria for selecting patients with hepatocellular carcinoma for liver transplantation: A multicenter cohort study using the alpha-fetoprotein model as a survival predictor.

The lifetime utility of liver transplantation (LT) in patients with hepatocellular carcinoma (HCC) is still controversial. The aim of this study was to ascertain when LT is cost-effective for HCC patients, with a view to proposing new transplant selection criteria. The study involved a real cohort of potentially transplantable Italian HCC patients (n = 2419 selected from the Italian Liver Cancer group database) who received nontransplant therapies. A non-LT survival analysis was conducted, the direct costs of therapies were calculated, and a Markov model was used to compute the cost utility of LT over non-LT therapies in Italian and US cost scenarios. Post-LT survival was calculated using the alpha-fetoprotein (AFP) model on the basis of AFP values and radiological size and number of nodules. The primary endpoint was the net health benefit (NHB), defined as LT survival benefit in quality-adjusted life years minus incremental costs (US $)/willingness to pay. The calculated median cost of non-LT therapies per patient was US $53,042 in Italy and US $62,827 in the United States. On Monte Carlo simulation, the NHB of LT was always positive for AFP model values ≤ 3 and always negative for values > 7 in both countries. A multivariate model showed that nontumor variables (patient's age, Child-Turcotte-Pugh [CTP] class, and alternative therapies) had the potential to shift the AFP model threshold of LT cost-ineffectiveness from 3 to 7. LT proved always cost-effective for HCC patients with AFP model values ≤ 3, whereas the cost-ineffectiveness threshold ranged between 3 and 7 using nontumor variables.

Liver Resection for Advanced Intrahepatic Cholangiocarcinoma: A Cost-Utility Analysis.

BACKGROUND: Data on cost-effectiveness and efficacy of hepatic resection (HR) for advanced intrahepatic cholangiocarcinoma (ICC) are lacking. We sought to estimate the cost-effectiveness of upfront HR resulting in an R1 resection (strategy A) relative to initial systemic chemotherapy (sCT) followed by possible curative HR (strategy B) for patients with advanced ICC. METHODS: A Markov model was developed using data from a systematic literature review. Three base cases were considered: (1) ICC >6 cm (2) ICC with vascular invasion (3) multi-focal ICC. A Monte Carlo simulation assessed outcomes including quality-adjusted life months (QALMs) and incremental cost-effectiveness ratio (ICER). RESULTS: The net health benefit (NHB) of strategy A versus strategy B was 1.4 QALMs for ICC >6 cm and 1.3 QALMs for ICC and vascular invasion; in contrast, there was a negative NHB for HR versus sCT for multi-focal ICC (-0.3 QALMs). In single nodule ICC >6 cm, the ICER of HR versus sCT was $22,482/quality-adjusted life years (QALY) and the ICER of HR versus sCT was $20,953/QALY for ICC with vascular invasion. In multi-focal ICC, the ICER of HR compared with sCT was $83,604/QALY. Patients with a higher American Society of Anesthesiologists score (coefficient 0.94), male sex (coefficient 0.43), low quality of life after sCT (coefficient -2.57) and T3 tumors (coefficient 0.53) had a better NHB for HR relative to sCT followed by potential surgery. CONCLUSIONS: For patients with large ICC or ICC and vascular invasion, HR was more cost-effective than sCT. In contrast, HR was not associated with a positive NHB relative to sCT for patients with multi-focal ICC, and therefore these patients should be treated with sCT rather than HR.

Hepatic Resection for Disappearing Liver Metastasis: a Cost-Utility Analysis.

BACKGROUND: We sought to estimate the cost-effectiveness of hepatic resection (HR) (strategy A) relative to surveillance plus 6 months of additional systemic chemotherapy (sCT) (strategy B) for patients with colorectal disappearing liver metastases (DLM). METHODS: A Markov model was developed using data from a systematic literature review. Three base cases were evaluated: (1) a 60-year-old patient with three lesions in the right hemi-liver who underwent 6 months of sCT, had normalized carcinoembryonic antigen (CEA), and was diagnosed with DLM through a computed tomography (CT) scan; (2) a 60-year-old patient with three lesions in the right hemi-liver who underwent 6 months of sCT, had normalized CEA, and was diagnosed with DLM through a magnetic resonance imaging (MRI) scan; and (3) a 60-year-old patient with three lesions in the right hemi-liver who underwent 6 months of sCT plus hepatic artery infusion (HAI), had normalized CEA, and was diagnosed with DLM through a MRI scan. The outcomes evaluated were quality-adjusted life months (QALMs), incremental cost-effectiveness ratio (ICER), and net health benefit (NHB). RESULTS: The NHB of strategy A versus strategy B was positive in base case 1 (7.7 QALMs, ICER $34.449/quality-adjusted life year (QALY)) and base case 2 (1.6 QALMs, ICER $43,948/QALY). In contrast it was negative (-0.2 QALMs, ICER $72,474/QALY) for base case 3. Monte Carlo simulation showed that strategy B is acceptable only in old patients (>60 years) with normalized CEA and MRI-based diagnosis. In younger patients, strategy B may reach cost-effectiveness only after sCT plus HAI. CONCLUSION: Surveillance of DLM after sCT was more beneficial and cost-effective among patients >60 years with multiple factors predictive of true complete pathological response, such as normalization of CEA, HAI therapy, BMI ≤30 kg/m(2), and diagnosis of DLM made through MRI.

Potential Economic Impact of Using a Restrictive Transfusion Trigger Among Patients Undergoing Major Abdominal Surgery.

IMPORTANCE: Transfusion practice among surgeons varies despite several evidence-based recommendations supporting the restrictive use of blood products. OBJECTIVE: To define the economic impact of liberal blood transfusions as assessed through an analysis of hemoglobin (Hb) triggers. DESIGN, SETTING, AND PARTICIPANTS: Using a prospective database, data on Hb levels that triggered a transfusion and overall blood product use were obtained for patients undergoing pancreas, liver, or colorectal surgery between January 1, 2010, and August 31, 2013, at Johns Hopkins Hospital. An economic analysis was performed using a range of costs for a single unit of packed red blood cells (PRBCs) based on actual institutional acquisition costs ($220/unit) and an estimated activity-based cost ($760/unit). Guidelines define a liberal Hb trigger as transfusion of PRBCs for an intraoperative Hb level of 10 g/dL or greater or a postoperative Hb level of 8 g/dL or greater (to convert to grams per liter, multiply by 10.0). MAIN OUTCOMES AND MEASURES: Numbers of surgical patients who received PRBC transfusion, estimated cost per transfusion, and estimated cost of excessive blood transfusions. RESULTS: Among 3027 patients, 942 (31.1%) received at least 1 PRBC transfusion, intraoperatively in 264 patients (8.7%), postoperatively in 429 (14.2%), or both in 249 (8.2%). A total of 4000 units of PRBCs (range, 0-167 units/patient) were transfused in the intraoperative (1581 units [39.5%]) and postoperative (2419 units [60.5%]) periods. Estimated total costs of PRBC transfusion ranged from $880,000 to $3,040,000, with marked variation in costs per patient across procedure type and surgeon. Among the 942 patients who received a transfusion, 456 units (11.4%) were transfused using a liberal trigger (intraoperative, 122 patients [13.0%]; postoperative, 79 patients [8.4%]). By adopting a restrictive trigger, total overall PRBC transfusion costs may have been reduced by $100,320 to $346,560 during the 44-month study period or $27,360 to $94,516 per year for patients undergoing a pancreas, liver, or colorectal resection. CONCLUSIONS AND RELEVANCE: More than 1 in 10 units of PRBCs were transfused using a liberal Hb trigger. Patient blood management programs should aim to identify and reduce liberal transfusion practice in the surgical patient.

Net health benefit of hepatic resection versus intraarterial therapies for neuroendocrine liver metastases: A Markov decision model.

BACKGROUND: Management of patients with neuroendocrine liver metastasis (NELM) remains controversial. We sought to compare the net health benefit (NHB) of hepatic resection (HR) versus intraarterial therapy (IAT) among patients with NELM. METHODS: A decision analytic Markov model was created to estimate and compare the cost effectiveness associated with different management strategies (HR vs IAT) for a simulated cohort of patients with NELM. The primary (base case) analysis was calculated based on a 57-year-old male patient with metachronous, symptomatic NELM that involved <25% of the liver in the absence of extrahepatic disease. The endpoints were quality-adjusted life-months (QALMs), quality-adjusted life-year (QALY), incremental cost-effectiveness ratio (ICER), and NHB. RESULTS: In the base case analysis, HR was strongly favored over IAT providing NHB of 20.0 QALMs and an ICER of $8,427 per QALY. In the Monte Carlo simulation, the greatest NHB for HR was among patients with functioning/symptomatic NELM, regardless of liver tumor burden. In the symptomatic group, IAT was favored only in a minority of old patients (>60 years) with extrahepatic disease and synchronous NELM. In contrast, in patients with nonfunctioning/asymptomatic NELM, hepatic tumor burden was the most important variable and HR was always cost ineffective in large tumors, independent of patient age and extrahepatic disease characteristics. CONCLUSION: A Markov decision model demonstrated that HR was the preferred strategy among patients with symptomatic NELM, regardless of hepatic disease burden. In contrast, IAT should be preferred for patients with large volume nonfunctioning/asymptomatic NELM.

Cost-effectiveness of pretransplant sofosbuvir for preventing recurrent hepatitis C virus infection after liver transplantation.

There are reports of pretransplant sofosbuvir (SOF) plus ribavirin being effective in preventing recurrent hepatitis C virus (HCV) infection after liver transplantation (LT). The aim of this study was to assess the cost-effectiveness of this strategy in the area served by the North Italy Transplant program. We retrospectively assessed the impact of HCV infection on post-LT survival in 2376 consecutive adult patients (MELD ≤ 25, unknown genotype, period 2004-2009) and the prevalence costs of conventional standard of care (SOC) antiviral therapy (pegylated interferon plus ribavirin) after LT. A Markov model was developed to compare two strategies: 12-24 weeks of SOF+ ribavirin for pre-LT anti-HCV treatment versus on-demand post-LT SOC antiviral therapy. Among the 1794 patients undergoing LT, 860 (48%) were HCV+ and 50% of them were given SOC therapy after LT (mean cost of drugs and adverse effect management = 14,421€ per patient). HCV etiology had a strong impact on post-LT survival (hazard ratio = 1.59, 95% CI = 1.22-2.09, P = 0.0007). After Monte Carlo simulation, pre-LT SOF therapy showed a median survival benefit of 1.5 quality-adjusted life years and an Incremental cost-effectiveness ratio (ICER) of 30,663€/QALY, proving cost-effective in our particular Italian scenario. The costs of SOF therapy, sustained viral response rate 12 weeks after LT, and recipient's age were the main ICER predictors at multivariate analysis. This study proposes a dynamic model based on real-life data from northern Italy for adjusting the costs of pre-LT direct-acting antiviral therapies to the actual sustained virological response reached after LT.

The relative net health benefit of liver resection, ablation, and transplantation for early hepatocellular carcinoma.

BACKGROUND: There are no conclusive cost-effectiveness studies measuring the efficacy of salvage LT after liver resection (LR) and radiofrequency ablation (RFA) in patients with early hepatocellular carcinoma (HCC) and compensated cirrhosis. The aim of the present study is to compare liver transplantation (LT) versus locoregional therapy plus salvage LT (to treat tumor recurrence) in patients with early HCC and compensated cirrhosis. METHODS: Reference case: 55-year old male with HCC within Milan criteria and Child-Pugh A cirrhosis. The analysis was performed in two geographical cost settings: USA and Italy. Survival benefit measured in quality-adjusted life years (QALYs), costs (C) in US$, incremental cost-effectiveness, willingness to pay, and net health benefit (NHB). RESULTS: In the base-case analysis, NHB of LT vs. LR and RFA was -1.7 and -1.3 years for single tumor ≤3 cm, -1.2 and -0.7 for single nodules measuring 3.1-5 cm and -0.7 and -0.7 for multi-nodular tumor ≤3 cm in Italy. In USA, NHB of LT versus LR and RFA were -1.2 and -0.8 years for single tumor ≤3 cm, -0.9 and -0.5 for single nodules measuring 3.1-5 cm, and -0.5 and -0.4 for multi-nodular tumor ≤ 3 cm. On the Monte Carlo simulation, only young patients with multi-nodular HCC and short waiting list time had a positive NHB. Salvage LT proved to be an ineffective cost strategy after RFA or LR. CONCLUSION: In patients with HCC within Milan criteria and Child-Pugh A cirrhosis, LR and RFA were more cost-effective than LT. Salvage LT was not cost-effective.