Predictors of axillary node response in node-positive patients undergoing neoadjuvant chemotherapy for breast cancer.

BACKGROUND: The ability to accurately predict which patients will achieve a pathologic complete response (pCR) after neoadjuvant chemotherapy could help identify those who could safely be spared the potential morbidity of axillary lymph node dissection. We performed a retrospective analysis of a cohort of clinically node-positive patients managed with neoadjuvant chemotherapy with the goal of identifying predictors of axillary pCR. METHODS: Eligible patients were aged 18 years or older, had clinical T1-T4, N1-N3, M0 breast cancer and received neoadjuvant chemotherapy followed by surgical axillary lymph node staging between 2001 and 2017 at Misericordia Hospital, Edmonton, Alberta. Patient data, including tumour characteristics, details of neoadjuvant chemotherapy, imaging results before and after neoadjuvant chemotherapy, and final pathologic analysis, were collected from the appropriate provincial electronic data repositories. We summarized the data using descriptive statistics. We characterized associations between clinical/tumour characteristics and pCR using univariate and multivariate regression analysis. RESULTS: Of the 323 patients included in the study, 130 (40.2%) achieved axillary pCR. Absence of residual disease in the breast was associated with axillary pCR (odds ratio 6.74, 95% confidence interval 2.89-15.67). HER2-positive, triple-negative and ER-positive/PR-negative/HER2-negative tumours were significantly associated with a pCR on univariate analysis; the association trended toward significance on multivariate analysis. CONCLUSION: Our findings support the routine use of neoadjuvant chemotherapy and sentinel lymph node biopsy in patients with an absence of residual disease in the breast, and potentially in those with HER2-positive or triple-negative subtypes, and highlight the ER-positive/PR-negative biomarker subtype as a potential predictor of nodal response.

Predictors and outcomes of bleed after sleeve gastrectomy: an analysis of the MBSAQIP data registry.

BACKGROUND: Bleeding after laparoscopic sleeve gastrectomy (LSG) is an important complication associated with significant morbidity and a drastic increase in healthcare resources. Multiple strategies have been developed to minimize bleeding, including varying bougie size, line reinforcement, and intra-operative tranexamic acid. These techniques, however, have been implemented without a clear understanding of the pre-, intra-, and postoperative predictors of bleeding in patients undergoing SG. OBJECTIVES: The purpose of this study was to examine predictors and outcomes associated with postoperative bleeding in patients undergoing LSG. SETTING: The Metabolic and Bariatric Surgery Accreditation and Quality Improvement data registry. METHODS: We identified Metabolic and Bariatric Surgery Accreditation and Quality Improvement patients who underwent LSG in 2015 and 2016. Primary outcomes of interest include identifying the prevalence, impact, and predictors of bleeding in LSG patients. Our secondary outcomes of interest include characterizing overall complication rates in LSG patients. Univariate analysis of pre-, intra-, and postoperative variables was performed using Χ2 tests for categorical data and independent sample t test for continuous data. A nonparsimonious multivariable logistic regression model was then developed to determine predictive factors for development of postoperative bleed. RESULTS: A total of 175,353 patients underwent LSG from 2015 to 2016. The majority of patients were female (79.0%), with a mean age of 44.4 ± 12.0 years and a mean body mass index of 45.2 kg/m2 ± standard deviation of 7.9 kg/m2. A total of 1116 (.6%) patients had a postoperative bleed. Bleeding was associated with a mortality of 1.0% versus .1% among patients without bleeding. The mean operative time was 74.0 ± 36.6 minutes with a mean bougie size of 36.9 ± 2.9 Fr, and a mean pylorus distance of 4.80 ± 1.1 cm. Staple-line reinforcement was used in 67.8% of patients while 22.4% were oversewn. Bleeds were associated with a statistically significant increase in all complications, readmission, reoperation, and mortality rates at 30 days. The following statistically significant independent predictors of bleed after LSG were identified using multivariable logistic regression analysis: bougie size, age, prior cardiac procedure, hypertension, renal insufficiency, therapeutic anticoagulation, diabetes, obstructive sleep apnea, and operative length. Staple-line reinforcement, staple-line oversewing, and higher body mass index were found to be protective for bleed after adjusting for confounders and interactions. An increase in pylorus distance did show a signal toward a protective effect; however, this was not statistically significant. CONCLUSION: Bleeding after LSG is associated with increased complications, readmission and reoperation rates, and mortality at 30 days. Staple-line reinforcement techniques independently predict a lower risk of postoperative bleeding after LSG. Adoption of these techniques may therefore have an important role in reducing morbidity and mortality for patients who undergo LSG.

Antibiotic use in prevention of anal fistulas following incision and drainage of anorectal abscesses: A systematic review and meta-analysis.

BACKGROUND: Treatment of anorectal abscesses continues to revolve around early surgical drainage and control of perianal sepsis. Yet even with prompt drainage, abscess recurrence and postoperative fistula formation rates are as high as 40% within 12 months. These complications are thought to be associated with inadequate drainage, elevated bacterial load, or a noncryptoglandular etiology of disease. Postoperative antibiotics have been used to account for these limitations, but their use is controversial and only weakly supported by current guidelines due to low-quality evidences. The aim of the present study was to perform a systematic review and meta-analysis of the current literature to determine the role of antibiotics in prevention of anal fistula following incision and drainage of anorectal abscesses. METHODS: Literature search was conducted using Medline, EMBASE, Scopus, the Cochrane Library, and Web of Science databases from 1946 to April 2018. Search terms were "perianal OR anal OR fistula-in-ano OR ischiorectal OR anorectal AND abscess AND antibiotics" and was limited to human studies in the English language. Literature review and data extraction were completed using PRISMA guidelines. A total of six studies with 817 patients were included for systematic review. The weighted mean age was 37.8 years, 20.4% of patients were female, and the follow up ranged from one to 30 months. Antibiotic courses varied by study, and duration ranged from five to 10 days. Of included patients, 358 (43.8%) underwent management without antibiotics while 459 (56.2%) patients were treated with antibiotics. Fistula rate in subjects receiving antibiotics was 16% versus 24% in those not receiving postoperative antibiotics. Meta-analysis revealed a statistically significant protective effect for antibiotic treatment (3 studies, OR 0.64; CI 0.43-0.96; P = 0.03). CONCLUSIONS: Antibiotic therapy following incision and drainage of anorectal abscesses is associated with a 36% lower odds of fistula formation. An empiric 5-10-day course of antibiotics following operative drainage may avoid the morbidity of fistula formation in otherwise healthy patients, although quality of evidence is low. Further randomized trials are needed to fully clarify the role, duration, and type of antibiotics best suited for postoperative prevention of fistula following drainage of anorectal abscesses.

Predictors and outcomes of leak after Roux-en-Y gastric bypass: an analysis of the MBSAQIP data registry.

BACKGROUND: Gastrointestinal leak is one of the most severe postoperative complications after Roux-en-Y gastric bypass (RYGB), occurring in up to 2% of all patients. This has led to adoption of simpler procedures, such as sleeve gastrectomy, which have improved safety profiles but potentially less effective long-term metabolic outcomes. Yet, in contrast to sleeve gastrectomy, a paucity of modern literature exists regarding predictors of leak for RYGB. OBJECTIVES: The purpose of this study was to examine gastrointestinal leak in patients undergoing RYGB using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement data registry. METHODS: We identified all Metabolic and Bariatric Surgery Accreditation and Quality Improvement patients who underwent RYGB in 2015 and 2016. Primary outcomes of interest include identifying the prevalence, impact, and predictors of leak in RYGB patients. Our secondary outcomes of interest include characterizing overall complication rates in RYGB patients. Univariate analysis of pre-, intra-, and postoperative variables was performed using Χ2 tests for categoric data and independent sample t test for continuous data. A nonparsimonious multivariable logistic regression model was then developed to determine predictive factors for development of leak. SETTING: All centers belonging to the Metabolic and Bariatric Surgery Accreditation and Quality Improvement data registry. RESULTS: A total of 77,596 patients underwent RYGB from 2015 to 2016. The majority of patients were female (79.8%), white (75.9%), and underwent laparoscopic RYGB (89.7%). The mean age of patients was 45.2 years (standard deviation 11.9) with a mean body mass index of 46.3 kg/m2 (standard deviation 8.17). Complication rates for RYGB were low with a mortality of .16% and a total complication rate of 7.5%. A total of 476 leaks were identified with an overall leak rate of .6% and a mortality of 1.5%. Leak was associated with a statistically significant increase in all complications as well as readmission, reoperation, and mortality rates at 30 days. Multivariable logistic regression analysis revealed the following statistically significant independent predictors of leak: body mass index, age, operative length, American Society of Anesthesiologists score >3, prior pulmonary embolus, and partially dependent functional status. Albumin was the only independent protective variable after adjusting for confounders and interactions. CONCLUSION: Using the robust Metabolic and Bariatric Surgery Accreditation and Quality Improvement database, we found RYGB to be a safe procedure with low morbidity and mortality. The overall leak rate was .6% with leak significantly increasing all other complications, readmission, reoperation, and mortality rates at 30 days. Logistic regression identified prior pulmonary embolus and partially dependent functional status as the 2 largest predictors of leak while increased albumin was the only protective factor. Optimizing preoperative nutrition and strength in these patients through structured multidisciplinary programs may therefore have a role in the ongoing improvement of outcomes after RYGB.

Rates of reoperation and nonoperative intervention within 30 days of bariatric surgery.

BACKGROUND: Complications arising from laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) are not insignificant and can necessitate additional invasive interventions or reoperations. OBJECTIVES: In this study, we identify early complications that result in nonoperative and operative interventions after LSG and LRYGB, the timeframe within which to expect them, and factors that influence the likelihood of their occurrence. SETTING: Multi-institutional database from across North America. METHODS: Data for this study were obtained from Metabolic and Bariatric Accreditation and Quality Improvement Program participant use files for 2015 and 2016. Statistical analysis was performed using STATA 15. Univariate analysis using Χ2 for categoric data and independent t test for continuous data was performed to determine between group differences. Multivariable logistic regression analysis was used to identify predictors of operative and nonoperative reinterventions. RESULTS: In 2015 and 2016, 243,747 underwent LRYGB or LSG, of which 3013 (1.24%) required a second operative procedure and 1536 (0.63%) required an invasive but nonoperative intervention. Complications occurred in 5.48% of LRYGB patients and 2.28% of LSG patients, the most common of which was bleeding. LSG was associated with far fewer nonoperative and operative interventions (.85% versus 2.2%, respectively) than LRYGB (.67% versus 2.5%). Renal insufficiency, including dialysis dependency, was an important predictor of reoperations among bariatric surgery patients. This was also true of nonoperative interventions; however, history of pulmonary embolism, and use of therapeutic anticoagulation were marginally stronger predictors. CONCLUSIONS: In a representative, multinational sample, operative and nonoperative interventions were half as likely among LSG patients compared with LRYGB; however, overall rates still remained low. These findings, in conjunction with new efficacy data demonstrating comparable long-term weight loss between LRYGB and LSG, provide further support for the safety, effectiveness, and cost efficiency of LSG.

Substance use patterns and HIV-1 RNA viral load rebound among HIV-positive illicit drug users in a Canadian setting.

BACKGROUND: Active illicit drug use can present a barrier to the medical management of HIV infection by complicating adherence to antiretroviral therapy (ART). Plasma HIV-1 RNA viral load (VL) rebound, defined as a period of detectable HIV VL following ART and VL suppression, can lead to the generation of viral resistance and potential treatment failure. We sought to investigate the contribution of substance use patterns on rates of VL rebound. METHODS: We used data from the ACCESS study, a long-running community-recruited prospective cohort of HIV-positive people who use illicit drugs in Vancouver, Canada, a setting of universal no-cost HIV treatment. We analysed time to VL rebound (that is, two consecutive observations ≥1,000 copies/ml) after ART initiation and sustained viral suppression (that is, two consecutive observations <50 copies/ml) using extended Cox regression models with a recurrent events framework. RESULTS: Between May 1996 and November 2013, 564 ART-exposed participants achieved at least one instance of VL suppression and contributed 1,893.8 person-years of observation. Over follow-up, 198 (35.1%) participants experienced ≥ one instance of VL rebound. In adjusted analyses, VL rebound was associated with younger age (adjusted hazard ratio [AHR] =0.97, 95% CI: 0.95, 0.98), heroin injection (≥ daily versus < daily, AHR =1.52, 95% CI: 1.01, 2.30), crack use (≥ daily versus < daily, AHR = 1.73, 95% CI: 1.08, 1.92) and heavy alcohol use (≥ four versus < four drinks/day, AHR =1.97, 95% CI: 1.17, 3.31). CONCLUSIONS: The present study suggests that in addition to heavy alcohol use, high-intensity illicit drug use, particularly ≥ daily heroin injection and ≥ daily crack smoking are risk factors for VL rebound. In addition to the impact of high-intensity drug use on health-care engagement and ART adherence, some evidence exists on the direct impact of psychoactive substances on ART metabolism and the natural progression of HIV disease. At-risk individuals should be provided additional supports to preserve virological control and maintain the benefits of ART.

Indocyanine green for the prevention of anastomotic leaks following esophagectomy: a meta-analysis.

BACKGROUND: Intraoperative evaluation with fluorescence angiography using indocyanine green (ICG) offers a dynamic assessment of gastric conduit perfusion and can guide anastomotic site selection during an esophagectomy. This study aims to evaluate the predictive value of ICG for the prevention of anastomotic leak following esophagectomy. METHODS: A comprehensive search of electronic databases using the search terms "indocyanine/fluorescence" AND esophagectomy was completed to include all English articles published between January 1946 and 2018. Articles were selected by two independent reviewers. The quality of included studies was assessed using the Methodological Index for Non-Randomized Studies (MINORS) instrument. RESULTS: Seventeen studies were included for meta-analysis after screening and exclusions. The pooled anastomotic leak rate when ICG was used was found to be 10%. When limited to studies without intraoperative modifications, the pooled sensitivity, specificity, and diagnostic odds ratio were 0.78 (95% CI 0.52-0.94; p = 0.089), 0.74 (95% CI 0.61-0.84; p = 0.012), and 8.94 (95% CI 1.24-64.21; p = 0.184), respectively. Six trials compared ICG with an intraoperative intervention to improve perfusion to no ICG. ICG with intervention was found to have a risk reduction of 69% (OR 0.31, 95% CI 0.15-0.63). CONCLUSIONS: In non-randomized trials, the use of ICG as an intraoperative tool for visualizing microvascular perfusion and conduit site selection to decrease anastomotic leaks is promising. However, poor data quality and heterogeneity in reported variables limits generalizability of findings. Randomized, multi-center trials are needed to account for independent risk factors for leak rates and to better elucidate the impact of ICG in predicting and preventing anastomotic leaks.

The Fatty Liver Index has limited utility for the detection and quantification of hepatic steatosis in obese patients.

PURPOSE: Noninvasive tools for the detection of hepatic steatosis are needed. The Fatty Liver Index (FLI), which includes body mass index (BMI), waist circumference, triglycerides, and γ-glutamyl-transferase, has been proposed as a screening tool for fatty liver. Our objective was to validate the FLI for the detection and quantification of hepatic steatosis in an obese population. METHODS: Patients with chronic liver disease and BMI ≥ 28 kg/m(2) underwent liver biopsy and FLI determination. FLI performance for diagnosing steatosis compared with biopsy was assessed using areas under receiver operating characteristic curves (AUROCs), and a novel model for the prediction of significant steatosis (≥5 %) was derived. RESULTS: Among 250 included patients, 65 % were male, and the median BMI was 33 kg/m(2); 48 % had nonalcoholic fatty liver disease, and 77 % had significant (≥5 %) steatosis. The FLI was weakly correlated with the percentage (ρ = 0.25, p = 0.0001) and grade of steatosis (ρ = 0.28, p < 0.00005). The median FLI was higher among patients with significant steatosis (91 vs. 80 with <5 % steatosis; p = 0.0001) and the AUROC for this outcome was 0.67 (95 % CI 0.59-0.76). At an optimal FLI cut-off of 79, the FLI was 81 % sensitive and 49 % specific, and had positive and negative predictive values of 84 and 43 %, respectively. A novel index including triglycerides, glucose, alkaline phosphatase, and BMI outperformed the FLI for predicting significant steatosis [AUROCs 0.78 vs. 0.68; p = 0.009 (n = 247)]. CONCLUSIONS: In obese patients, the FLI is a poor predictor of significant steatosis and has limited utility for steatosis quantification compared with liver histology. A novel index including triglycerides, glucose, alkaline phosphatase, and BMI may be useful, but requires validation.