Quality of Life in Ugandan Children and Young Adults After Surgery for Congenital Heart Disease: Mixed Methods Approach.

Background: Health-related quality of life (HRQOL) is a critical issue for patients undergoing surgery for congenital heart disease (CHD) but has never been assessed in a low-income country. We conducted a cross-sectional mixed methods study with age-matched healthy siblings serving as controls at the Uganda Heart Institute. Methods: One-hundred fifteen CHD pediatric and young adult patients and sibling control participants were recruited. Health-related quality of life was assessed using the Pediatric Quality of Life Inventory Version 4.0 in participants ages 5-17 and 36-Item Short Form Survey for young adults aged 18-25. A subset of 27 participants completed face-to-face interviews to supplement quantitative findings. Results: Eighty-six pediatric (age 5-17) sibling and parent pairs completed Peds QOL surveys, and 29 young adult (age 18-25) sibling pairs completed SF-36 surveys. One third of patients had surgery in Uganda. Ventricular septal defects and tetralogy of Fallot were the most common diagnoses. Health-related quality of life scores in patients were lower across all domains compared to control participants in children. Reductions in physical and emotional domains of HRQOL were also statistically significant for young adults. Variables associated with lower HRQOL score on multivariate analysis in pediatric patients were younger age in the physical and emotional domains, greater number of surgeries in the physical domain and surgery outside Uganda in the school domain. The only predictor of lower HRQOL score in young adults was surgery outside Uganda in the social domain. Qualitative interviews identified a number of themes that correlated with survey results including abandonment by family, isolation from peers and community, financial hardship and social stigmatization. Conclusion: Health-related quality of life was lower in Ugandan patients after CHD surgery than siblings. Younger patients and those who had surgery outside of Uganda had lower HRQOL. These data have important implications for patients undergoing CHD surgery in LMIC and have potential to inform interventions.

A uniform strategy of primary repair of tetralogy of Fallot: Transventricular approach results in low reoperation rate in the first decade.

OBJECTIVES: To review outcomes after a uniform strategy of transventricular repair of tetralogy of Fallot. METHODS: A total of 244 consecutive patients underwent transventricular primary repair of tetralogy of Fallot from 2004 to 2019. Median age at operation was 71 days; 57 (23%) patients were premature; 57 (23%) patients had low birth weight (<2.5 kg), and 40 (16%) had genetic syndromes. The diameter of pulmonary valve annulus, right pulmonary artery (PA), and left PA were 6.0 ± 1.8 mm (z score, -1.7 ± 1.3), 4.3 ± 1.4 mm (z score, -0.9 ± 1.2) and 4.1 ± 1.5 mm (z score, -0.5 ± 1.3). RESULTS: Three (1.2%) operative deaths were recorded. Ninety patients (37%) underwent transannular patching. Postoperative echocardiographic peak right ventricular outflow tract gradient decreased from 72 ± 27 mm Hg to 21 ± 16 mm Hg. Median intensive care unit and hospital stay were 3 and 7 days. The survival rate at 10 years was 94.6% ± 1.8%. Reintervention was required 86 times (55 catheter interventions) in 56 patients following tetralogy of Fallot repair. The freedom from all-cause reintervention rate at 10 years was 70.5% ± 3.6%. Cyanotic spells (hazard ratio, 2.14; 95% CI, 1.22-3.90; P < .01) and smaller pulmonary valve annulus z score (hazard ratio, 1.26; 95% CI, 1.01-1.59; P = .04) were associated with increasing risk of all reinterventions. Freedom from redo surgery for right ventricular outflow tract obstruction and right ventricular dilatation at 10 years were, respectively, 85.0% ± 3.1% and 98.7% ± 0.9%. Freedom from valve implantation was 96.7% ± 1.5% at 10 years. CONCLUSIONS: A uniform strategy of primary repair of tetralogy of Fallot through a transventricular approach resulted in low reoperation rate in the first decade. The need of pulmonary valve implantation was limited to <4% at 10 years.

Optimal hepatic surgery: Are we making progress in North America?

BACKGROUND: The aim of this analysis was to determine whether optimal outcomes have increased in recent years. Hepatic surgery is high risk, but regionalization and minimally invasive approaches have evolved. Best practices also have been defined with the goal of improving outcomes. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database was queried. Analyses were performed separately for partial (≤2 segments), major (≥3 segments), and all hepatectomies. Optimal hepatic surgery was defined as the absence of mortality, serious morbidity, need for a postoperative invasive procedure or reoperation, prolonged length of stay (<75th percentile) or readmission. Tests of trend, χ2, and multivariable analyses were performed. RESULTS: From 2014 to 2018, 17,082 hepatectomies, including 11,862 partial hepatectomies and 5,220 major hepatectomies, were analyzed. Minimally invasive approaches increased from 25.6% in 2014 to 29.6% in 2018 (P < .01) and were performed more frequently for partial hepatectomies (34.2%) than major hepatectomies (14.4%) (P < .01). Operative time decreased from 220 minutes in 2014 to 208 minutes in 2018 (P < .05) and was lower in partial hepatectomies (189 vs 258 minutes for major hepatectomies) (P < .01). Mortality (0.7%) and length of stay (4 days) were lower for partial hepatectomies compared with major hepatectomies (1.9%; 6 days), and length of stay decreased for both partial hepatectomies (5 days in 2014 to 4 days in 2018) and major hepatectomies (6 days in 2014 to 6 days in 2018) (all P < .01). Postoperative sepsis (2.9% in 2014 and 2.4% in 2018), bile leaks (6% in 2014 and 4.8% in 2018), and liver failure (3.7% in 2014 and 3.3% in 2018) decreased for all patients (<.05). On multivariable analyses, overall morbidity decreased for major hepatectomies (OR 0.95, 95% CI 0.91-0.99) and all hepatectomies (OR 0.97, 95% CI 0.94-0.99, both P < .01), and optimal hepatic surgery increased over time for partial hepatectomies (OR 1.05, 95% CI 1.02-1.09) and all hepatectomies (OR 1.04, 95% CI 1.02-1.07, both P < .01). CONCLUSION: Over a 5-year period in North America, minimally invasive hepatectomies have increased, while operative time, postoperative sepsis, bile leaks, liver failure, and prolonged length of stay have decreased. Optimal hepatic surgery has increased for partial and all hepatectomies and is achieved more often in partial than in major resections.

Assessment of Magnet status and Textbook Outcomes among medicare beneficiaries undergoing hepato-pancreatic surgery for cancer.

BACKGROUND: The relationship between hospital Magnet status recognition and postoperative outcomes following complex cancer surgery remains ill-defined. We sought to characterize Textbook Outcome (TO) rates among patients undergoing (HP) surgery for cancer in Magnet versus non-Magnet centers. METHODS: Medicare beneficiaries undergoing HP surgery between 2015 and 2017 were identified. The association of postoperative TO (no complications/extended length-of-stay/90-day mortality/90-day readmission) with Magnet designation was examined after adjusting for competing risk factors. RESULTS: Among 10,997 patients, 21.3% (n = 2337) patients underwent surgery at Magnet hospitals (non-Magnet centers: 78.7%, n = 8660). On multivariable analysis, patients undergoing HP surgery had comparable odds of achieving a TO at Magnet versus non-Magnet hospitals (hepatectomy: odds ratio [OR]: 1.05, 95% confidence interval [CI]: 0.94-1.17; pancreatectomy-OR: 0.88, 95% CI: 0.74-1.06). Patients treated at hospitals with a high nurse-to-bed ratio had higher odds of achieving a TO irrespective of whether they received surgery at Magnet (high vs. low nurse-to-bed ratio; OR: 1.38; 95% CI: 1.01-1.89) or non-Magnet centers (OR: 1.26; 95% CI: 1.10-1.45). Similarly, hospital HP volume was strongly associated with higher odds of TO following HP surgery in both Magnet (Leapfrog compliant vs. noncompliant; OR: 1.24, 95% CI: 1.06-1.44) and non-Magnet centers (OR: 1.18; 95% CI: 1.11-1.26). CONCLUSION: Hospital Magnet designation was not an independent factor of superior outcomes after HP surgery. Rather, hospital-level factors such as nurse-to-bed ratio and HP procedural volume drove outcomes.

Machine learning predicts unpredicted deaths with high accuracy following hepatopancreatic surgery.

BACKGROUND: Machine learning to predict morbidity and mortality-especially in a population traditionally considered low risk-has not been previously examined. We sought to characterize the incidence of death among patients with a low estimated morbidity and mortality risk based on the National Surgical Quality Improvement Program (NSQIP) estimated probability (EP), as well as develop a machine learning model to identify individuals at risk for "unpredicted death" (UD) among patients undergoing hepatopancreatic (HP) procedures. METHODS: The NSQIP database was used to identify patients who underwent elective HP surgery between 2012-2017. The risk of morbidity and mortality was stratified into three tiers (low, intermediate, or high estimated) using a k-means clustering method with bin sorting. A machine learning classification tree and multivariable regression analyses were used to predict 30-day mortality with a 10-fold cross validation. C statistics were used to compare model performance. RESULTS: Among 63,507 patients who underwent an HP procedure, median patient age was 63 (IQR: 54-71) years. Patients underwent either pancreatectomy (n=38,209, 60.2%) or hepatic resection (n=25,298, 39.8%). Patients were stratified into three tiers of predicted morbidity and mortality risk based on the NSQIP EP: low (n=36,923, 58.1%), intermediate (n=23,609, 37.2%) and high risk (n=2,975, 4.7%). Among 36,923 patients with low estimated risk of morbidity and mortality, 237 patients (0.6%) experienced a UD. According to the classification tree analysis, age was the most important factor to predict UD (importance 16.9) followed by preoperative albumin level (importance: 10.8), disseminated cancer (importance: 6.5), preoperative platelet count (importance: 6.5), and sex (importance 5.9). Among patients deemed to be low risk, the c-statistic for the machine learning derived prediction model was 0.807 compared with an AUC of only 0.662 for the NSQIP EP. CONCLUSIONS: A prognostic model derived using machine learning methodology performed better than the NSQIP EP in predicting 30-day UD among low risk patients undergoing HP surgery.

County-Level Variation in Utilization of Surgical Resection for Early-Stage Hepatopancreatic Cancer Among Medicare Beneficiaries in the USA.

INTRODUCTION: Geographic variations in access to care exist in the USA. We sought to characterize county-level disparities relative to access to surgery among patients with early-stage hepatopancreatic (HP) cancer. METHODS: Data were extracted from the Surveillance, Epidemiology, and End Results (SEER)-Medicare Linked database from 2004 to 2015 to identify patients undergoing surgery for early-stage HP cancer . County-level information was acquired from the Area Health Resources Files (AHRF). Multivariable logistic regression analysis was performed to assess factors associated with utilization of HP surgery on the county level. RESULTS: Among 13,639 patients who met inclusion criteria, 66.9% (n = 9125) were diagnosed with pancreatic cancer and 33.1% (n = 4514) of patients had liver cancer. Among patients diagnosed with early-stage liver and pancreas malignancy, two-thirds (n = 8878, 65%) underwent surgery. Marked county-level variation in the utilization of surgery was noted among patients with early-stage HP cancer ranging from 57.1% to more than 83.3% depending on which county a patient resided. After controlling for patient and tumor-related characteristics, counties with the highest quartile of patients living below the poverty level had 35% lower odds of receiving surgery for early stage HP cancer compared patients who lived in a county with the lowest proportion of patients below the poverty line (OR 0.65, 95% CI 0.55-0.77). In addition, patients residing in counties with the highest surgeon-to-population ratio (OR 2.01, 95% CI 1.52-2.65), as well as the highest hospital bed-to-population ratio (OR 1.29, 95% CI 1.07-1.54), were more likely to undergo surgical treatment for an early-stage HP malignancy. CONCLUSION: Area-level variations among patients undergoing surgery for early-stage HP cancer were mainly due to differences in structural measures and county-level factors. Policies targeting high-poverty counties and improvement in structural measures may reduce variations in utilization of surgery among patients diagnosed with early-stage HP cancer.

Quality of Care Among Medicare Patients Undergoing Pancreatic Surgery: Safety Grade, Magnet Recognition, and Leapfrog Minimum Volume Standards-Which Quality Benchmark Matters?

BACKGROUND: The association of national quality benchmarking metrics with postoperative outcomes following complex surgery remains unknown. We assessed the relationship between the "quality trifactor" of Leapfrog minimum volume standards, Hospital Safety Grade A, and Magnet Recognition with outcomes of Medicare patients undergoing pancreatectomy. METHODS: The Standard Analytic Files (SAF) merged with Leapfrog Hospital Survey and Leapfrog Safety Scores Denominator Files were reviewed to identify Medicare patients who underwent pancreatic procedures between 2013 and 2015. Primary outcomes were overall and serious complications, as well as 30- and 90-day mortality. Multivariable logistic regression analyses were conducted to evaluate possible associations among hospitals meeting the quality trifactor and short-term outcomes. RESULTS: Among 4853 Medicare patients, 909 (18.7%) underwent pancreatectomy at hospitals meeting the quality trifactor. Among 260 hospitals, 7.3% (n = 19) met the quality trifactor. Safety Grade A (48.8%, n = 127) was the most commonly met criterion followed by Magnet Recognition (36.2%, n = 94); the Leapfrog minimum volume standards were achieved by 25% (n = 65) of hospitals. Patients undergoing surgery at hospitals that were only Safety Grade A and Magnet designated, but did not meet Leapfrog criteria, had higher odds of serious complications (OR 1.59, 95% CI 1.00-2.51). In contrast, patients undergoing treatment at hospitals having all three designations (i.e., the quality trifactor) had 40% and 39% lower odds of both serious complications (OR 0.60, 95% CI 0.37-0.97) and 90-day mortality (OR 0.61, 95% CI 0.42-0.89), respectively. In turn, patients undergoing pancreatectomy at quality trifactor hospitals had higher odds of experiencing the composite quality measure textbook outcome (OR 1.28, 95% CI 1.03-1.59) versus patients undergoing pancreatectomy at non-trifactor hospitals. CONCLUSION: While Safety Grade A and Magnet designation alone were not associated with higher odds of an optimal composite outcome following pancreatectomy, compliance with Leapfrog criteria to achieve the "quality trifactor" metric was associated with lower odds of serious complications and mortality.

Long-Term Outcomes after Spleen-Preserving Distal Pancreatectomy for Pancreatic Neuroendocrine Tumors: Results from the US Neuroendocrine Study Group.

BACKGROUND: The adoption of spleen-preserving distal pancreatectomy (SPDP) for malignant disease such as pancreatic neuroendocrine tumors (pNETs) has been controversial. The objective of the current study was to assess the impact of SPDP on outcomes of patients with pNETs. METHODS: Patients undergoing a distal pancreatectomy for pNET between 2002 and 2016 were identified in the US Neuroendocrine Tumor Study Group database. Propensity score matching (PSM) was used to compare short- and long-term outcomes of patients undergoing SPDP versus distal pancreatectomy with splenectomy (DPS). RESULTS: Among 621 patients, 103 patients (16.6%) underwent an SPDP. Patients who underwent SPDP were more likely to have lower BMI (median, 27.5 [IQR 24.0-31.2] vs. 28.7 [IQR 25.7-33.6]; p = 0.005) and have undergone minimally invasive surgery (n = 56, 54.4% vs. n = 185, 35.7%; p < 0.001). After PSM, while the median total number of lymph nodes examined among patients who underwent an SPDP was lower compared with DPS (3 [IQR 1-8] vs. 9 [5-13]; p < 0.001), 5-year overall survival (OS) and recurrence-free survival (RFS) were comparable (OS: 96.8 vs. 92.0%, log-rank p = 0.21, RFS: 91.1 vs. 84.7%, log-rank p = 0.93). In addition, patients undergoing SPDP had less intraoperative blood loss (median, 100 mL [IQR 10-250] vs. 150 mL [IQR 100-400]; p = 0.001), lower incidence of serious complications (n = 13, 12.8% vs. n = 28, 27.5%; p = 0.014), and shorter length of stay (median: 5 days [IQR 4-7] vs. 6 days [IQR 5-13]; p = 0.049) compared with patients undergoing DPS. CONCLUSION: SPDP for pNET was associated with acceptable perioperative and long-term outcomes that were comparable to DPS. SPDP should be considered for patients with pNET.

The impact of individual surgeon on the likelihood of minimal invasive surgery among Medicare beneficiaries undergoing pancreatic resection.

BACKGROUND: The objective of the current study was to evaluate the impact of the individual surgeon on the use of minimally invasive pancreatic resection. METHODS: The Medicare 100% Standard Analytic Files were reviewed to identify Medicare beneficiaries who underwent pancreatic resection between 2013 and 2017. The impact of patient- and procedure-related factors on the likelihood of minimally invasive pancreatic resection was investigated. RESULTS: A total of 12,652 (85.4%) patients underwent open pancreatic resection, whereas minimally invasive pancreatic resection was performed in 2,155 (14.6%) patients. Unadjusted rates of minimally invasive pancreatic resection ranged from 0% in the bottom volume tertile to 35.3% in the top tertile. Although patients with emergency admission were less likely to undergo minimally invasive pancreatic resection (odds ratio = 0.43, 95% confidence interval 0.32-0.58), patients operated on more recently had a higher chance of minimally invasive pancreatic resection (year 2017; odds ratio = 1.51, 95% confidence interval 1.28-1.79). On multivariable analysis, there was over a 3-fold variation in the odds that a patient underwent minimally invasive versus open pancreatic resection based on the individual surgeon (median odds ratio = 3.27, 95% confidence interval 2.98-3.56). Patients who underwent pancreatectomy by a low-volume, minimally invasive pancreatic resection surgeon had higher odds of 90-day mortality after surgery (odds ratio = 1.33, 95% confidence interval: 1.16-1.59), as well as higher observed/expected mortality compared with individuals treated by high-volume surgeons. CONCLUSION: The likelihood of undergoing minimally invasive pancreatic resection among Medicare beneficiaries was markedly influenced by the individual treating surgeon rather than patient- or procedure-level factors.

Variation in Drain Management Among Patients Undergoing Major Hepatectomy.

BACKGROUND: Although previous studies have suggested that drain management is highly variable, data on drain placement and timing of drain removal among patients undergoing hepatic resection remain scarce. The objective of the current study was to define the utilization of drain placement among patients undergoing major hepatic resection. METHODS: The ACS NSQIP-targeted hepatectomy database was used to identify patients who underwent major hepatectomy between 2014 and 2017. Association between day of drain removal, timing of discharge, and drain fluid bilirubin on postoperative day (POD) 3 (DFB-3) was assessed. Propensity score matching (PSM) was used to compare outcomes of patients with a drain removed before and after POD 3. RESULTS: Among 5330 patients, most patients had an abdominal drain placed at the time of hepatic resection (n = 3075, 57.7%). Of 2495 patients with data on timing of drain removal, only 380 patients (15.2%) had their drain removed by POD 3. Almost 1 in 6 patients (n = 441, 17.7%) were discharged home with the drain in place. DFB-3 values correlated poorly with POD of drain removal (R2 = 0.0049). After PSM, early drain removal (≤ POD 3) was associated with lower rates of grade B or C bile leakage (2.1% vs. 7.1%, p = 0.008) and prolonged length of hospital stay (6.0% vs. 12.7%, p = 0.009) compared with delayed drain removal (> POD 3). CONCLUSIONS: Roughly 3 in 5 patients had a drain placed at the time of major hepatectomy and only 1 in 7 patients had the drain removed early. This study demonstrated the potential benefits of early drain removal in an effort to improve the quality of care following major hepatectomy.

Assessment of hospital quality and safety standards among Medicare beneficiaries undergoing surgery for cancer.

BACKGROUND: We sought to assess the relationship between Leapfrog minimum volume standards, Hospital Safety Grades, and Magnet recognition with outcomes among patients undergoing rectal, lung, esophageal, and pancreatic resection for cancer. METHODS: Standard Analytical Files linked with the Leapfrog Hospital Survey and the Leapfrog Safety Scores Denominator Files were used to identify Medicare patients who underwent surgery for cancer from 2016 to 2017. Multivariable logistic regression analysis was used to examine textbook outcomes relative to Leapfrog volume, safety grades, and Magnet recognition. RESULTS: Among 26,268 Medicare beneficiaries, 7,491 (28.5%) were treated at hospitals meeting the quality trifactor (Leapfrog, safety grade A, and Magnet recognition) vs 18,777 (71.5%) at hospitals not meeting ≥1 designation. Patients at trifactor hospitals had lower odds of complications (odds ratio = 0.83, 95% confidence interval: 0.76-0.89), prolonged duration of stay (odds ratio = 0.89, 95% confidence interval: 0.82-0.97), and higher odds of experiencing textbook outcome (odds ratio = 1.12, 95% confidence interval: 1.06-1.19). Patients undergoing surgery for lung (odds ratio = 1.19, 95% confidence interval: 1.10-1.30) and pancreatic cancer (odds ratio = 1.37, 95% confidence interval: 1.21-1.55) at trifactor hospitals had higher odds of textbook outcome, whereas this effect was not noted after esophageal (odds ratio = 1.16, 95% confidence interval: 0.90-1.48) or rectal cancer (odds ratio = 1.11, 95% confidence interval: 0.98-1.27) surgery. Leapfrog minimum volume standards mediated the effect of the quality trifactor on patient outcomes. CONCLUSION: Quality trifactor hospitals had better short-term outcomes after lung and pancreatic cancer surgery compared with nontrifactor hospitals.

Predicting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma.

BACKGROUND: The objective of the current study was to develop a model to predict the likelihood of occult lymph node metastasis (LNM) prior to resection of intrahepatic cholangiocarcinoma (ICC). METHODS: Patients who underwent hepatectomy for ICC between 2000 and 2017 were identified using a multi-institutional database. A novel model incorporating clinical and preoperative imaging data was developed to predict LNM. RESULTS: Among 980 patients who underwent resection of ICC, 190 (19.4%) individuals had at least one LNM identified on final pathology. An enhanced imaging model incorporating clinical and imaging data was developed to predict LNM ( https://k-sahara.shinyapps.io/ICC_imaging/ ). The performance of the enhanced imaging model was very good in the training data set (c-index 0.702), as well as the validation data set with bootstrapping resamples (c-index 0.701) and outperformed the preoperative imaging alone (c-index 0.660). The novel model predicted both 5-year overall survival (OS) (low risk 48.4% vs. high risk 18.4%) and 5-year disease-specific survival (DSS) (low risk 51.9% vs. high risk 25.2%, both p < 0.001). When applied among Nx patients, 5-year OS and DSS of low-risk Nx patients was comparable with that of N0 patients, while high-risk Nx patients had similar outcomes to N1 patients (p > 0.05). CONCLUSION: This tool may represent an opportunity to stratify prognosis of Nx patients and can help inform clinical decision-making prior to resection of ICC.

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.

Overall Tumor Burden Dictates Outcomes for Patients Undergoing Resection of Multinodular Hepatocellular Carcinoma Beyond the Milan Criteria.

OBJECTIVE: The objective of the current study was to define surgical outcomes after resection of multinodular hepatocellular carcinoma (HCC) beyond the Milan criteria, and develop a prediction tool to identify which patients likely benefit the most from resection. BACKGROUND: Liver resection for multinodular HCC, especially beyond the Milan criteria, remains controversial. Rigorous selection of the best candidates for resection is essential to achieve optimal outcomes after liver resection of advanced tumors. METHODS: Patients who underwent resection for HCC between 2000 and 2017 were identified from an international multi-institutional database. Patients were categorized according to Milan criteria status. Pre- and postoperative overall survival (OS) prediction models that included HCC tumor burden score (TBS) among patients with multinodular HCC beyond Milan criteria were developed and validated. RESULTS: Among 1037 patients who underwent resection for HCC, 164 (15.8%) had multinodular HCC beyond the Milan criteria. Among patients with multinodular HCC, 25 (15.2%) patients experienced a serious complication and 90-day mortality was 3.7% (n = 6). Five-year OS after resection of multinodular HCC beyond Milan criteria was 52.8%. A preoperative TBS-based model (5-year OS: low-risk, 73.7% vs intermediate-risk, 45.1% vs high-risk, 13.1%), and postoperative TBS-based model (5-year OS: low-risk, 80.1% vs intermediate-risk, 37.2% vs high-risk, not reached) categorized patients into distinct prognostic groups relative to long-term prognosis (both P < 0.001). Pre- and postoperative models could accurately stratify OS in an external validation cohort (5-year OS; low vs medium vs high risk; pre: 66.3% vs 25.2% vs not reached, P = 0.012; post: 61.4% vs 42.5% vs not reached, P = 0.045) Predictive accuracy of the pre- and postoperative models was good in the training (c-index; pre: 0.68; post: 0.71), internal validation (n = 2000 resamples) (c-index, pre: 0.70; post: 0.72) and external validation (c-index, pre: 0.67; post 0.68) datasets. TBS alone could stratify patients relative to 5-year OS after resection of multinodular HCC beyond Milan criteria (c-index: 0.65; 5-year OS; low TBS: 70.2% vs medium TBS: 54.7% vs high TBS: 16.7%; P < 0.001). The vast majority of patients with low and intermediate TBS were deemed low or medium risk based on both the preoperative (98.4%) and postoperative risk scores (95.3%). CONCLUSION: Prognosis of patients with multinodular HCC was largely dependent on overall tumor burden. Liver resection should be considered among patients with multinodular HCC beyond the Milan criteria who have a low- or intermediate-TBS.

Prognostic factors differ according to KRAS mutational status: A classification and regression tree model to define prognostic groups after hepatectomy for colorectal liver metastasis.

BACKGROUND: Although KRAS mutation status is known to affect the prognosis of patients with colorectal liver metastasis, the hierarchical association between other prognostic factors and KRAS status is not fully understood. METHODS: Patients who underwent a hepatectomy for colorectal liver metastasis were identified in a multi-institutional international database. A classification and regression tree model was constructed to investigate the hierarchical association between prognostic factors and overall survival relative to KRAS status. RESULTS: Among 1,123 patients, 29.9% (n = 336) had a KRAS mutation. Among wtKRAS patients, the classification and regression tree model identified presence of metastatic lymph nodes as the most important prognostic factor, whereas among mtKRAS patients, carcinoembryonic antigen level was identified as the most important prognostic factor. Among patients with wtKRAS, the highest 5-year overall survival (68.5%) was noted among patients with node negative primary colorectal cancer, solitary colorectal liver metastases, size <4.3 cm. In contrast, among patients with mtKRAS colorectal liver metastases, the highest 5-year overall survival (57.5%) was observed among patients with carcinoembryonic antigen <6 mg/mL. The classification and regression tree model had higher prognostic accuracy than the Fong score (wtKRAS [Akaike's Information Criterion]: classification and regression tree model 3334 vs Fong score 3341; mtKRAS [Akaike's Information Criterion]: classification and regression tree model 1356 vs Fong score 1396). CONCLUSION: Machine learning methodology outperformed the traditional Fong clinical risk score and identified different factors, based on KRAS mutational status, as predictors of long-term prognosis.

Recurrence beyond the Milan criteria after curative-intent resection of hepatocellular carcinoma: A novel tumor-burden based prediction model.

BACKGROUND: Accurate prediction of recurrence patterns of hepatocellular carcinoma (HCC) may allow for prioritization of patients for resection or transplantation as well as guide post-resection surveillance strategies. METHODS: Patients who underwent curative-intent R0 resection for HCC between 2000 and 2017 were identified using a multi-institutional database. A prognostic model that incorporated HCC tumor burden score (TBS) to predict recurrence beyond the Milan criteria (MC) was developed and validated. RESULTS: Among 718 patients who underwent R0 resection for HCC, 185 (25.8%) recurred within and 110 (15.3%) beyond the MC. On multivariable analysis, AFP more than 400 ng/mL (hazard ratio [HR] = 2.26; 95% confidence interval [CI]: 1.27-4.02), lymphovascular invasion (HR = 2.00; 95% CI: 1.14-3.50), and TBS (HR = 1.08; 95% CI: 1.03-1.12) were associated with recurrence beyond the MC. A weighted TBS-based score was constructed: [0.074*TBS + 0.692*lymphovascular invasion (yes: 1, no: 0) + 0.816*AFP > 400 (yes:1, no:0)]. Patients with a low, medium, and high TBS-based risk score had a 5-year incidence of recurring beyond the MC of 16.2%, 28.6%, and 47.2%, respectively (P < .001). The predictive accuracy of the model was very good in the training (C-index: 0.761) and validation (C-index: 0.706) datasets and outperformed the previously reported clinical risk score (CRS; C-index: 0.680). CONCLUSION: A TBS-based model accurately predicted recurrence beyond MC after curative-intent resection of HCC and outperformed the CRS. Incorporating TBS allows for better risk stratification and identifies patients in need of closer surveillance.

Is Patient Satisfaction Dictated by Quality of Care Among Patients Undergoing Complex Surgical Procedures for a Malignant Indication?

BACKGROUND: The current study aimed to define the relationship between patient satisfaction, hospital-level factors, and clinical outcomes among patients undergoing major surgery for cancer. METHODS: The Medicare Inpatient Standard Analytic Files were used to identify patients undergoing lung, esophageal, colorectal, hepatic, or pancreatic surgery between 2016 and 2017, and Hospital Consumer Assessment of Healthcare Providers and Systems survey data were used to assess performance in terms of patient satisfaction. RESULTS: Among 60,446 patients, half were female (n = 31,244, 52%) with a median age of 73 years (interquartile range [IQR] 69-78 years). Patients who underwent surgery for esophageal resection (odds ratio [OR] 2.44; 95% confidence interval [CI] 1.10-5.40) and were Caucasian (OR 2.43; 95% CI 2.11-2.81) had optimal patient satisfaction. Hospital level factors such as urban location (OR 3.69; 95% CI 3.16-4.29), 200 + beds (OR 3.58; 95% CI 3.09-4.13), greater inpatient surgical volume (OR 3.03; 95% CI 2.82-3.25), higher nurse-to-bed ratio (OR 4.57; 95% CI 4.25-4.92), non-profit hospital status (OR 1.14; 95% CI 1.01-1.29), and non-teaching hospital status (OR 1.52; 95% CI 1.39-1.65) were related to optimal patient satisfaction. In adjusted analysis, patients undergoing surgery at hospitals reporting poor or average patient satisfaction had 22% higher odds of 90-day mortality than patients undergoing surgery at optimal-satisfaction hospitals (OR 1.22; 95% CI 1.09-1.36). In addition, hospitals with the highest patient satisfaction scores also had the highest proportion of surgical cases that achieved the composite textbook outcome (TO) quality metric (OR 1.12; 95% CI 1.05-1.20). CONCLUSION: Higher patient satisfaction was strongly associated with hospital structural measures such as bed number, urban location, nurse-to-bed ratio, and "optimal" TO after cancer surgery. These data highlight how high quality of care can directly lead to improved patient satisfaction among surgical patients with cancer.

Assessing Textbook Outcomes Following Liver Surgery for Primary Liver Cancer Over a 12-Year Time Period at Major Hepatobiliary Centers.

INTRODUCTION: The objective of the current study was to comprehensively assess the change of practice in hepatobiliary surgery by determining the rates and the trends of textbook outcomes (TO) among patients undergoing surgery for primary liver cancer over time. METHODS: Patients undergoing curative-intent resection for primary liver malignancies, including hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC) between 2005 and 2017 were analyzed using a large, international multi-institutional dataset. Rates of TO were assessed over time. Factors associated with achieving a TO and the impact of TO on long-term survival were examined. RESULTS: Among 1829 patients, 944 (51.6%) and 885 (48.4%) individuals underwent curative-intent resection for HCC and ICC, respectively. Over time, patients were older, more frequently had ASA class > 2, albumin-bilirubin grade 2/3, major vascular invasion and more frequently underwent major liver resection (all p < 0.05). Overall, a total of 1126 (62.0%) patients achieved a TO. No increasing trends in TO rates were noted over the years (ptrend = 0.90). In addition, there was no increasing trend in the TO rates among patients undergoing either major (ptrend = 0.39) or minor liver resection (ptrend = 0.63) over the study period. Achieving a TO was independently associated with 26% and 37% decreased hazards of death among ICC (HR 0.74, 95%CI 0.56-0.97) and HCC patients (HR 0.63, 95%CI 0.46-0.85), respectively. CONCLUSION: Approximately 6 in 10 patients undergoing surgery for primary liver tumors achieved a TO. While TO rates did not increase over time, TO was associated with better long-term outcomes following liver resection for both HCC and ICC.

Inside the courtroom: An analysis of malpractice litigation in gallbladder surgery.

BACKGROUND: Cholecystectomy is one of the most commonly performed operations in the United States, yet it still carries up to a 6% risk of major morbidity. Lawsuits are a major source of emotional, financial, and personal stress for surgeons. We sought to characterize malpractice claims associated with gallbladder surgery as well as define contributing factors and costs with these claims. METHODS: The Westlaw database (Thomson Reuters Corporation, Toronto, Canada) was queried for jury verdicts and settlements related to cholecystectomy and malpractice between 2000 and 2018. Data were abstracted from the case files and details of the settlements, jury verdicts, and factors related to the claims were assessed. RESULTS: Among 231 cases, a plaintiff verdict was reached in 45 (19.5%) and a defendant verdict was reached in 122 (53%); other cases were either settled (n = 29, 12%), dismissed (n = 31, 13%), or denied (n = 4, 2%). Plaintiff cases often involved young (median age, 44 years [interquartile range: 35-57]) female (n = 146, 63%) patients. The attending surgeon accounted for 59% of defendants. Procedural error (49%), wrongful death (18%), or failure to treat in a timely manner (13%) were the most commonly cited reasons for litigation. Among the 134 cases where a second surgical procedure was performed, the most common types of procedures were biliary tract repair (n = 82, 61%) and bowel repair (n = 16, 12%). The total cost of the claims over the study period was $22 million with a median payout of $500,000; the median time from operative event to final disposition was over 5 years (interquartile range: 4-7). CONCLUSION: A plaintiff verdict or settlement was reached in 1 in 3 cases, and large payouts were common. Minimizing procedural error and improving care of patients after cholecystectomy complications should be emphasized.