Early safety of endoscopic sleeve gastroplasty in super obesity (body mass index > 50).

BACKGROUND: The prevalence of super obesity (body mass index [BMI] > 50) continues to rise. However, the adoption of bariatric surgery in this population remains very low. There are limited studies evaluating the utility of endoscopic sleeve gastroplasty (ESG) in super obesity. OBJECTIVES: The purpose of this study is to evaluate the short-term safety profile of ESG in patients with super obesity using data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database. SETTING: United States. METHODS: We retrospectively analyzed patients who underwent ESG and sleeve gastrectomy (SG) from 2016 to 2021. Patients with BMI >50 who underwent ESG were compared to ESG patients with BMI <50 and also SG patients with BMI >50. Primary outcomes included the incidence of severe adverse events (AEs), hospital readmission, reintervention, and reoperation within 30 days of the primary procedure. Secondary outcomes included procedure time, hospital length of stay, and total body weight loss at 30 days. RESULTS: There were no significant differences in AE, reoperations, hospital readmissions, or reinterventions for patients with super obesity undergoing ESG, compared to patients with BMI below 50. Mean total body weight loss was greater in patients with super obesity. There were no significant differences in AEs for patients with super obesity who underwent ESG versus SG, although ESG patients had more hospital readmissions, reinterventions, and reoperations. CONCLUSIONS: ESG may be performed safely, with comparable safety to SG, in patients with BMI as high as 70. However, further studies are needed to validate the feasibility and long-term efficacy prior to clinical implementation.

Associations between income and survival in cholangiocarcinoma: A comprehensive subtype-based analysis.

Backgrounds/Aims: Socioeconomic determinants of health are incompletely characterized in cholangiocarcinoma (CCA). We assessed how socioeconomic status influences initial treatment decisions and survival outcomes in patients with CCA, additionally performing multiple sub-analyses based on anatomic location of the primary tumor. Methods: Observational study using the 2018 submission of the Surveillance, Epidemiology, and End Results (SEER)-18 Database. In total, 5,476 patients from 2004-2015 with a CCA were separated based on median household income (MHI) into low income (< 25th percentile of MHI) and high income (> 25th percentile of MHI) groups. Seventy-three percent of patients had complete follow up data, and were included in survival analyses. Survival and treatment outcomes were calculated using R-studio. Results: When all cases of CCA were included, the high-income group was more likely than the low-income to receive surgery, chemotherapy, and local tumor destruction modalities. Initial treatment modality based on income differed significantly between tumor locations. Patients of lower income had higher overall and cancer-specific mortality at 2 and 5 years. Non-cancer mortality was similar between the groups. Survival differences identified in the overall cohort were maintained in the intrahepatic CCA subgroup. No differences between income groups were noted in cancer-specific or overall mortality for perihilar tumors, with variable differences in the distal cohort. Conclusions: Lower income was associated with higher rates of cancer-specific mortality and lower rates of surgical resection in CCA. There were significant differences in treatment selection and outcomes between intrahepatic, perihilar, and distal tumors. Population-based strategies aimed at identifying possible etiologies for these disparities are paramount to improving patient outcomes.

Early safety and efficacy comparison of endoscopic bariatric interventions.

BACKGROUND: Intragastric balloon (IGB) placement and endoscopic sleeve gastroplasty (ESG) are the 2 primary endoscopic bariatric therapies currently performed in the United States. Procedural selection is often based primarily on patient preference. There is a paucity of comparative data between these interventions. OBJECTIVES: The aim of this study is to compare the short-term safety and efficacy of IGB to ESG in the largest, direct comparative analysis to date. SETTING: Accredited bariatric centers across the United States and Canada. METHODS: We retrospectively analyzed patients who underwent IGB or ESG from 2016 to 2020 from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database. IGB patients were propensity matched (1:1) to ESG patients. We compared readmissions, reinterventions, serious adverse events (SAE), weight loss, procedure time, and length of stay between the 2 interventions. All outcomes were measured within 30 days of the initial procedure. RESULTS: A total of 1998 pairs of patients who underwent IGB and ESG were propensity matched with no difference in baseline characteristics. Patients who underwent ESG had more readmissions within 30 days. Patients who underwent IGB had more outpatient treatments for dehydration and re-interventions, with 3.7% of patients undergoing early balloon removal less than 30 days from implantation. Both procedures had similarly low rates of SAE (P > .05). ESG led to greater total body weight loss at 30 days. CONCLUSIONS: ESG and IGB are both safe procedures with comparably low rates of SAE. Higher rates of dehydration and re-interventions after IGB suggest that ESG is perhaps better tolerated.

Socioeconomic Disparities Affect Outcomes in Early-Stage Esophageal Adenocarcinoma: A SEER Analysis.

BACKGROUND & AIMS: Socioeconomic determinants of health are understudied in early stage esophageal adenocarcinoma. We aimed to assess how socioeconomic status influences initial treatment decisions and survival outcomes in patients with T1a esophageal adenocarcinoma. METHODS: We performed an observational study using the 2018 submission of the Surveillance, Epidemiology, and End Results-18 database. A total of 1526 patients from 2004 to 2015 with a primary T1aN0M0 esophageal adenocarcinoma were subdivided into 3 socioeconomic tertiles based on their median household income. Endoscopic trends over time, rates of endoscopic and surgical treatment, 2- and 5-year overall survival, cancer-specific mortality, and non-cancer-specific mortality were calculated. Statistical analysis was performed using R-studio. RESULTS: Patients within the lowest median household income tertile ($20,000-$54,390) were associated with higher cancer-specific mortality at 2 years (P < .01) and 5 years (P < .02), and lower overall survival at 2 and 5 years (P < .01) compared with patients in higher income tertiles. Patients with a higher income had a decreased hazard ratio for cancer-specific mortality (hazard ratio, 0.66; 95% CI, 0.45-0.99) in a multivariate Cox proportional hazards regression model. Patients within the higher income tertile were more likely to receive endoscopic intervention (P < .001), which was associated with improved cancer-specific mortality compared with patients who received primary surgical intervention (P = .001). The South had lower rates of endoscopy compared with other regions. CONCLUSIONS: Lower median household income was associated with higher rates of cancer-specific mortality and lower rates of endoscopic resection in T1aN0M0 esophageal adenocarcinoma. Population-based strategies aimed at identifying and rectifying possible etiologies for these socioeconomic and geographic disparities are paramount to improving patient outcomes in early esophageal cancer.

Endoscopic Sleeve Gastroplasty: A Safe Bariatric Intervention for Class III Obesity (BMI > 40).

PURPOSE: Endoscopic sleeve gastroplasty (ESG) is primarily offered to patients with class I and II obesity (BMI 30-40), although there are no guidelines specifying applicability. There is little data comparing ESG to bariatric surgery in patients with class III obesity (BMI > 40). This study evaluates the short-term safety of ESG compared to sleeve gastrectomy (SG) and gastric bypass (RYGB) in patients with class III obesity. METHODS: We retrospectively analyzed over 500,000 patients who underwent ESG, SG, and RNYGB from 2016 to 2020 in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database. ESG patients were stratified by BMI to compare outcomes between class I and II versus class III obese patients. Class III obese patients who underwent ESG were also propensity matched to SG and RNYGB patients for matched comparisons. Primary outcomes included adverse events (AE), readmissions, re-operations, and re-interventions within 30 days. Secondary outcomes included procedure time, length of stay (LOS), and total body weight loss (%TBWL) at 30 days. RESULTS: Among ESG patients, those with BMI > 40 had no difference in AE, readmissions, or re-interventions versus patients with BMI 30-40 (p > 0.05), while achieving greater %TBWL at 30 days (p < 0.05). In comparison to surgery, ESG had similar AE to SG and less than RNYGB, while producing comparable %TBWL to SG and RNYGB at 30 days. CONCLUSIONS: The feasibility and safety of ESG in patients with class III obesity are comparable to patients with class I and II obesity. Additionally, the safety of ESG in patients with class III obesity is comparable to SG and safer than RYGB. Endoscopic sleeve gastroplasty: a safe bariatric intervention for class III obesity (BMI > 40).

Comparison of endoscopic sleeve gastroplasty versus surgical sleeve gastrectomy: a Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database analysis.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is an incisionless, transoral, restrictive bariatric procedure designed to imitate sleeve gastrectomy (SG). Comparative studies and large-scale population-based data are limited. Additionally, no studies have examined the impact of race on outcomes after ESG. This study aims to compare short-term outcomes of ESG with SG and evaluate racial effects on short-term outcomes after ESG. METHODS: We retrospectively analyzed over 600,000 patients in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database from 2016 to 2020. We compared occurrences of adverse events (AEs), readmissions, reoperations, and reinterventions within 30 days after procedures. Multivariate regression evaluated the impact of patient factors, including race, on AEs. RESULTS: A total of 6054 patients underwent ESG and 597,463 underwent SG. AEs were low after both procedures with no significant difference in major AEs (SG vs ESG: 1.1% vs 1.4%; P > .05). However, patients undergoing ESG had more readmissions (3.8% vs 2.6%), reoperations (1.4% vs .8%), and reinterventions (2.8% vs .7%) within 30 days (P < .05). Race was not significantly associated with AEs after ESG, with black race associated with a higher risk of AEs in SG. CONCLUSIONS: ESG demonstrates a comparable major AE rate with SG. Race did not impact short-term AEs after ESG. Further prospective studies long-term studies are needed to compare ESG with SG.

Relative adrenal insufficiency in the non-critically ill patient with cirrhosis: A systematic review and meta-analysis.

BACKGROUND & AIMS: Characterization of relative adrenal insufficiency (RAI) in cirrhosis is heterogeneous with regard to studied patient populations and diagnostic methodology. We aimed to describe the prevalence and prognostic importance of RAI in non-critically ill patients with cirrhosis. METHODS: A systematic review and meta-analysis was performed using MeSH terms and Boolean operators to search five large databases (Ovid-MEDLINE, ScienceDirect, Web of Science, Cochrane Library and ClinicalTrials.gov). The population of interest was patients with cirrhosis and without critical illness. The primary outcome was the pooled prevalence of RAI as defined by a peak total cortisol level <18 µg/dl, delta total cortisol <9 µg/dl or composite of the two thresholds in response either a standard-dose or low-dose short synacthen test. Odds ratios and standardized mean differences from random-effects models estimated important clinical outcomes and patient characteristics by adrenal functional status. RESULTS: Twenty-two studies were included in final analysis, comprising 1991 patients with cirrhosis. The pooled prevalence of RAI was 37% (95% CI 33-42%). The prevalence of RAI varied by Child-Pugh classification, type of stimulation test used, specific diagnostic threshold and by severity of illness. Ninety-day mortality was significantly higher in patients with RAI (OR 2.88, 95% CI 1.69-4.92, I2 = 15%, p < 0.001). CONCLUSIONS: Relative adrenal insufficiency is highly prevalent in non-critically ill patients with cirrhosis and associated with increased mortality. Despite the proposed multifactorial pathogenesis, no studies to date have investigated therapeutic interventions in this specific population.

Impact of Proceduralist Specialty on Outcomes Following Endoscopic Sleeve Gastroplasty.

PURPOSE: Endoscopic sleeve gastroplasty (ESG) is a novel minimally invasive weight loss procedure designed to mimic gastric volume reduction of surgical sleeve gastrectomy. Currently, both bariatric surgeons and gastroenterologists perform ESG, and early reports suggest that ESG is safe and effective for weight loss. However, as gastroenterologists and bariatric surgeons have variations in training backgrounds, it is important to evaluate for potential differences in clinical outcomes. To date, there are no studies comparing the impact of proceduralist specialization on outcomes of ESG. This study aims to assess whether proceduralist specialization impacts short-term safety and efficacy after ESG. METHODS: We retrospectively analyzed over 6,000 patients who underwent ESG from 2016 to 2020 in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database. ESG patients were stratified into two groups depending on the specialty of the physician performing the procedure, and propensity matched using baseline patient characteristics. We primarily compared adverse events (AE), readmissions, re-operations, and re-interventions within 30 days after procedure. Secondary outcomes included procedure time, length of stay (LOS), early weight loss, and emergency department (ED) visits after procedure. RESULTS: There was no difference in AE in ESG performed by gastroenterologists and bariatric surgeons. ESG performed by bariatric surgeons demonstrated a trend towards higher rate of re-operations within 30 days. ESG performed by gastroenterologists had more ED visits but did not lead to higher rate of re-intervention. LOS was shorter in ESG performed by gastroenterologists, but procedure time was longer. CONCLUSIONS: ESG is safely performed by both gastroenterologists and bariatric surgeons.

Concordance of ICD-10 Codes and the Clinical Diagnosis of Alcoholic Hepatitis.

INTRODUCTION: Many studies on alcoholic hepatitis (AH) use the International Classification of Disease (ICD) coding to identify patients. Data regarding the diagnostic accuracy of ICD codes for AH are limited. METHODS: A total of 151 patients with ICD-10 codes for AH were reviewed for the presence or absence of AH using standardized diagnostic criteria. RESULTS: Sixty-eight of the 151 patients met AH criteria, corresponding to a positive predictive value of 45%. Patients with AH experienced higher model for end-stage liver disease and mortality than those who did not ( P < 0.05). DISCUSSION: Our results suggest ICD-10 codes are not reliable for identifying AH. Studies using the ICD codes should be interpreted cautiously.

Clinical and Biologic Characteristics and Outcomes in Young and Middle-Aged Patients With Laryngeal Cancer: A Retrospective Cohort Analysis.

OBJECTIVE: To describe the clinical and biologic characteristics and outcomes of young and middle-aged (YMA; <65 years) patients according to the presence or absence of traditional risk factors for laryngeal cancer. STUDY DESIGN: Retrospective cohort analysis. SETTING: Single-institution academic medical center. METHODS: Patients without a history of clinically significant tobacco use or heavy alcohol use were defined as "nontraditional": ≤5 pack-years, ≤5 years smoked, ≤14 alcoholic drinks per week, and ≥15-year interval from last tobacco abuse use to diagnosis. Remaining patients were categorized as "traditional." Select tumor samples were evaluated for bacterial and viral DNA by multiplex polymerase chain reaction. RESULTS: Seventy-eight YMA patients with primary laryngeal squamous cell carcinoma were identified, 23% (n = 18) of whom were nontraditional. Nontraditional patients were younger than traditional patients (median age, 51 vs 59 years; P < .001). Twenty-eight tumors were prospectively tested for human papillomavirus (HPV), and nontraditional patients were more likely to exhibit high-risk HPV (57% vs 5%, P < .01). Among 17 select tumors (nontraditional, n = 8; traditional, n = 9), 35% exhibited HPV16 (nontraditional, 63%; traditional, 11%; P = .05). Other viruses were identified but did not differ according to risk status: herpesviruses (40%) and Merkel cell polyomavirus (7%). Chlamydia, ß-HPV, and γ-HPV DNA was not detected in any samples. Median length of follow-up was 42 months. On adjusted analyses, nontraditional patients exhibited nonsignificantly improved overall survival (hazard ratio, 0.24 [95% CI, 0.03-1.82]; P = .17) and disease-free survival (hazard ratio, 0.34 [95% CI, 0.10-1.23]; P = .08) as compared with traditional patients. CONCLUSION: Almost one-quarter of YMA patients lacked characteristic risk factors for laryngeal squamous cell carcinoma, and their tumors exhibited a higher prevalence of high-risk HPV. The significance of HPV16 and other tumor viruses with outcomes in nontraditional patients should be evaluated further.

Oncologic outcomes in primary squamous cell carcinoma of the auricle: a retrospective cohort analysis.

PURPOSE: The prognostic significance of auricular location in cutaneous squamous cell carcinoma (cSCC) is controversial. We aimed to characterize risk factors for, and evaluate the cumulative incidence of, locoregional recurrence in a cohort of patients with primary auricular cSCC. METHODS: The study design was a single-institution retrospective cohort review from 1/2007 to 12/2016. RESULTS: Among 851 potentially eligible individuals, 178 patients with primary auricular cSCC met strict criteria for inclusion. Median follow-up was 32 months, 93% were AJCC 8th edition (AJCC8) stage I and 6% were AJCC8 stage II. Most underwent Mohs micrographic surgery (MMS; 97%) and the remainder underwent wide local excision ± parotidectomy ± neck dissection ± adjuvant therapy (3%). Recurrences occurred in seven patients (4%): six were local and one was regional. The 3-year cumulative incidence of local and regional recurrence for AJCC8 stage I-II tumors were 1% (95% CI 0-5%) and 0%, respectively. Among ten patients upstaged to pT3 disease who underwent MMS alone, none recurred locoregionally. Compared to their respective counterparts, advanced stage, PNI, and LVI associated with a significantly increased risk of locoregional recurrence. CONCLUSIONS: Our findings suggest that auricular location may not be a significant risk factor for cSCC staging systems. In the absence of other risk factors, unimodal therapy appears adequate for patients with primary, stage I-II auricular cSCC. The prognostic significance of pT3 auricular cSCC stage due to depth of invasion alone should be evaluated further.

Insulin and exercise improved muscle function in rats with severe burns and hindlimb unloading.

Prior work established that exercise alleviates muscle function loss in a clinically relevant rodent model mimicking the clinical sequelae of severely burned patients. On the basis of these data, we posit that pharmacologic treatment with insulin combined with exercise further mitigates loss of muscle function following severe burn with immobilization. Twenty-four Sprague-Dawley rats were assessed and trained to complete a climbing exercise. All rats followed a standardized protocol to mimic severe burn patients (40% total body surface area scald burn); all rats were immediately placed into a hindlimb unloading apparatus to simulate bedrest. The rats were then randomly assigned to four treatment groups: saline vehicle injection without exercise (VEH/NEX), insulin (5 U/kg) injection without exercise (INS/NEX), saline vehicle with daily exercise (VEH/EX), and insulin with daily exercise (INS/EX). The animals were assessed for 14 days following injury. The groups were compared for multiple variables. Isometric tetanic (Po) and twitch (Pt) forces were significantly elevated in the plantaris and soleus muscles of the INS/EX rats (P < 0.05). Genomic analysis revealed mechanistic causes with specific candidate changes. Molecular analysis of INS/EX rats revealed Akt phosphorylated by PDPK1 was increased with this treatment, and it further activated downstream signals mTOR, eEF2, and GSK3-ß (P < 0.05). Furthermore, muscle RING-finger protein-1 (MuRF-1), an E3 ubiquitin ligase, was reduced in the INS/EX group (P < 0.05). Insulin and resistance exercise have a positive combined effect on the muscle function recovery in this clinically relevant rodent model of severe burn. Both treatments altered signaling pathways of increasing protein synthesis and decreasing protein degradation.