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Unlabelled: The SHAPE (Screened Health Assessment and Pacer Evaluation) trial was a 24 month randomized multicenter placebo-controlled study to determine the efficacy of an implantable gastric stimulator (IGS) for weight loss. This report is an investigator-initiated sub-study at one site designed to assess whether IGS affects plasma levels of ghrelin and peptide YY (PYY). The device was implanted in all subjects but was activated in the TREATMENT group (n = 7, BMI = 41.5 ± 2.0 kg/m2) and remained inactive in the CONTROL (n = 6, BMI = 39.5 ± 1.7 kg/m2) during the first 12 months. IGS was activated in both groups during months 12-24. Fasting venous blood was drawn at months 0, 12, and 24 and an oral glucose tolerance test (OGTT) was performed at month 12. Although there was no difference in weight loss at 6 months (Control: -6.6 ± 1.5% vs.Treatment: -6.2 ± 1.4%), at 24 months the CONTROL group exhibited weight gain from baseline (+2.2 ± 1.5%) that was significantly different from the weight loss in the TREATMENT group (-1.9 ± 1.4%; P < 0.05). At 12 months, fasting ghrelin was significantly increased (P < 0.05) in the TREATMENT group (285 ± 35 to 336 ± 35 pg/ml; weight change, -4.9 ± 1.4%), but not in the CONTROL (211 ± 36 to 208 ± 35 pg/ml; weight change, -3.4 ± 1.5%). No significant change was observed in postprandial suppression of plasma ghrelin or in fasting and postprandial PYY levels. In conclusion, IGS does not prevent the increase in fasting plasma ghrelin levels associated with weight loss. Further studies are needed to determine whether changes in technology can improve weight loss and maintenance, perhaps using gut hormones as biomarkers of possible efficacy. [ABSTRACT FROM AUTHOR]

Background: An important aspect of a new surgical technique is whether it can be performed by other surgeons in other institutions. The authors report the first 297 cases in a multi-institutional and multinational review of laparoscopic cholecystectomy performed via a single portal of entry.Methods: Data were collected retrospectively for the initial patients undergoing single-port cholecystectomy by 13 surgeons who performed these procedures in their institutions after training by the authors. The review included operative time, blood loss, incision length, length of hospital stay (LOS), necessary additional trocars, and other parameters important to cholecystectomy. A database of all the single-port-access (SPA) surgeries performed by the surgeons included demographic and procedural details, LOS, complications, and initial follow-up data.Results: To date, 297 single-port cholecystectomies have been performed for a variety of diagnoses, primarily cholelithiasis. The average operative time was 71 min, and the average LOS was 1-2 days. The average blood loss was minimal. The use of additional port sites outside the umbilicus occurred in 34 of the cases. Of the 35 intraoperative cholangiograms performed, 34 were successful. No significant complications occurred except for seromas and minor postoperative wound infections. These results are comparable with those for standard multiport cholecystectomy. In addition, no access site hernias (ASH) occurred.Conclusions: The findings demonstrate that SPA surgery is an alternative to multiport laparoscopy with fewer scars and better cosmesis. One factor affecting the rate for adoption of SPA surgery among other surgeons is the reproducibility of this new procedure. Although this study had insufficient data to determine fully the benefits of SPA surgery, the feasibility of this procedure with safe, acceptable results was demonstrated in this initial large series across multinational institutions. [ABSTRACT FROM AUTHOR]

Enthusiasm for natural orifice transluminal endoscopic surgery (NOTES) has been partly tempered by the reality that most NOTES procedures to date have been laparoscopically assisted. After safely performing transvaginal cholecystectomy in an IACUC-approved porcine model, the authors embarked on an institution review board (IRB)-approved protocol for ultimate performance of pure NOTES cholecystectomy in humans. They describe their experience performing a true NOTES transvaginal cholecystectomy after safely accomplishing three laparoscopically assisted or hybrid procedures in humans. One of the patients was a 35-year-old woman presenting with symptoms of biliary colic. Ultrasound confirmed gallstones, and her liver enzymes were normal. Pneumoperitoneum to 15 mmHg was obtained via a transvaginal trocar placed through a colpotomy made under direct vision. A double-channel endoscope then was advanced into the abdomen. To overcome the retracting limitations of currently available endoscopes, the authors used an extra-long 5-mm articulating retractor placed into the abdomen via a separate colpotomy made under direct vision using the flexible endoscope in a retroflexed position. Endoscopically placed clips were used for control of both the cystic duct and the artery. These techniques obviated the need for any transabdominally placed instruments or needles. This patient was the first to undergo a completely NOTES cholecystectomy at the authors' institution, and to their knowledge, in the United States. She was discharged on the day of surgery and at this writing has not experienced any complication after 1 month of follow-up evaluation. Performance of NOTES transvaginal cholecystectomy without aid of laparoscopic or needleoscopic instruments is feasible and safe for humans. Additional experience with this technique are required before studies comparing it with standard laparoscopy and hybrid techniques are appropriate. [ABSTRACT FROM AUTHOR]

Natural orifice transluminal endoscopic surgery (NOTES) is considered the new frontier for minimally invasive surgery. NOTES procedures such as peritoneoscopy, splenectomy, and cholecystectomy in animal models have been described. The aim of our experiment was to determine the feasibility and technical aspects of a new endoluminal surgical procedure. After approval from Columbia's IACUC, a transvaginal laparoscopically assisted endoscopic cholecystectomy was performed on four 30 kg Yorkshire pigs. The first step was to insert a 1.5 cm endoscope into the vagina under direct laparoscopic vision. Then the gallbladder was reached and, with the help of a laparoscopic grasper to hold up the gallbladder, the operation was performed. At the end of the procedure the gallbladder was snared out through the vagina attached to the endoscope. There were no intraoperative complications such as bleeding, common bile duct or endo-abdominal organ damage. Total operative time ranged between 110 and 155 min. Based on our experience in the porcine model, we believe that a transvaginal endoscopic cholecystectomy is feasible in humans. [ABSTRACT FROM AUTHOR]

Background: Patients with obesity who undergo bariatric surgery achieve sustained weight loss but are often left with excess skin folds that cause functional and psychological deficits. To remove excess skin, patients can undergo postbariatric BCS; however, cost and lack of insurance coverage present a significant barrier for many patients., Objectives: This study aimed to characterize the financial impact of treatment on all patients who received bariatric surgery and to compare between those receiving only bariatric surgery and those with postbariatric BCS., Setting: Email-based survey study at an urban tertiary care center., Methods: Surveys that included the COST-FACIT were sent to patients with a history of bariatric surgery and/or post-bariatric BCS., Results: One hundred and five respondents completed the survey, of which 19 reported having postbariatric BCS. Patients with postbariatric BCS had slightly higher COST scores than those receiving bariatric surgery only, but this difference was not significant (15.6 versus 17.8, P = .23). Most patients (76%) did not have an awareness of BCS or BCS cost prior to bariatric surgery, and many (68%) had more loose skin than anticipated., Conclusions: Financial toxicity was similar across all postbariatric surgery patients surveyed regardless of history of BCS. However, survey respondents noted a gap between patient education and expectations around loose skin and body contouring that can be addressed through improved presurgical counseling., (Copyright © 2024 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: The utility of routine post-discharge VTE prophylaxis after bariatric surgery remains a matter of debate. While inpatient chemical prophylaxis decreases the risk of fatal pulmonary embolism, most thromboembolic events occur after discharge and carry high morbidity and mortality. To address this risk, apixaban was introduced as extended prophylaxis for 30 days after surgery., Materials and Methods: The study ranges between 1/2014 and 7/2022. Apixaban was incorporated as routine extended prophylaxis protocol in 05/2017 and is dosed at 2.5 mg BID for 30 days. There were two study groups: those who received apixaban on discharge (n = 1443; 60%) and those who did not (n = 953; 40%). Patients with concern for postoperative bleeding (hypotension, unexplained tachycardia with hematocrit drop > 6%, hematocrit drop > 9%), or on preoperative anticoagulant/antiplatelet therapy (except aspirin), were not discharged on apixaban. Post-discharge VTE, readmission, transfusion, and reoperation rates were compared between groups., Results: There were 2396 consecutive primary bariatric operations: sleeve gastrectomy (1949; 81%), Roux-en-Y gastric bypass (419; 18%), and duodenal switch (28; 1%). There were no post-discharge VTEs in patients treated with apixaban vs. five (0.5%) VTEs in patients who did not receive treatment; p = 0.02. There was a higher incidence in post-discharge bleeding events in the apixaban group (0.5 vs 0.3%; p = 0.75), mostly requiring readmission for monitoring without intervention or transfusion. In the apixaban group, one patient underwent EGD for bleeding while another required blood transfusion; there were no reoperations for bleeding., Conclusion: There were no post-discharge VTEs in patients who received apixaban. Treatment was associated with a higher risk of self-resolving bleeding events. This study adds to the increasing body of evidence supporting the benefit of routine, extended oral chemoprophylaxis after bariatric surgery., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Context: The prevalence of obesity is burgeoning among African American and Latina women; however, few studies investigating the skeletal effects of bariatric surgery have focused on these groups., Objective: To investigate long-term skeletal changes following Roux-en-Y gastric bypass (RYGB) in African American and Latina women., Design: Four-year prospective cohort study., Patients: African American and Latina women presenting for RYGB (n = 17, mean age 44, body mass index 44 kg/m2) were followed annually for 4 years postoperatively., Main Outcome Measures: Dual-energy x-ray absorptiometry (DXA) measured areal bone mineral density (aBMD) at the spine, hip, and forearm, and body composition. High-resolution peripheral quantitative computed tomography measured volumetric bone mineral density (vBMD) and microarchitecture. Individual trabecula segmentation-based morphological analysis assessed trabecular morphology and connectivity., Results: Baseline DXA Z-Scores were normal. Weight decreased ~30% at Year 1, then stabilized. Parathyroid hormone (PTH) increased by 50% and 25-hydroxyvitamin D was stable. By Year 4, aBMD had declined at all sites, most substantially in the hip. There was significant, progressive loss of cortical and trabecular vBMD, deterioration of microarchitecture, and increased cortical porosity at both the radius and tibia over 4 years. There was loss of trabecular plates, loss of axially aligned trabeculae, and decreased trabecular connectivity. Whole bone stiffness and failure load declined. Risk factors for bone loss included greater weight loss, rise in PTH, and older age., Conclusions: African American and Latina women had substantial and progressive bone loss, deterioration of microarchitecture, and trabecular morphology following RYGB. Further studies are critical to understand the long-term skeletal consequences of bariatric surgery in this population., (© The Author(s) 2020. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Fibrinolysis is initiated by tissue-type plasminogen activator (tPA) and inhibited by plasminogen activator inhibitor 1 (PAI-1). In obese humans, plasma PAI-1 and tPA proteins are increased, but PAI-1 dominates, leading to reduced fibrinolysis and thrombosis. To understand tPA-PAI-1 regulation in obesity, we focused on hepatocytes, a functionally important source of tPA and PAI-1 that sense obesity-induced metabolic stress. We showed that obese mice, like humans, had reduced fibrinolysis and increased plasma PAI-1 and tPA, due largely to their increased hepatocyte expression. A decrease in the PAI-1 (SERPINE1) gene corepressor Rev-Erbα increased PAI-1, which then increased the tPA gene PLAT via a PAI-1/LRP1/PKA/p-CREB1 pathway. This pathway was partially counterbalanced by increased DACH1, a PLAT-negative regulator. We focused on the PAI-1/PLAT pathway, which mitigates the reduction in fibrinolysis in obesity. Thus, silencing hepatocyte PAI-1, CREB1, or tPA in obese mice lowered plasma tPA and further impaired fibrinolysis. The PAI-1/PLAT pathway was present in primary human hepatocytes, and associations among PAI-1, tPA, and PLAT in livers from obese and lean humans were consistent with these findings. Knowledge of PAI-1 and tPA regulation in hepatocytes in obesity may suggest therapeutic strategies for improving fibrinolysis and lowering the risk of thrombosis in this setting.

Background: Laparoscopic sleeve gastrectomy (SG) has surpassed Roux-en-Y gastric bypass (RYGB) as the most prevalent bariatric procedure worldwide. While RYGB and SG demonstrate equivalent short-term weight loss, long-term weight loss tends to be greater after RYGB. Differences in the effect of these procedures on gastrointestinal hormones that regulate energy homeostasis are felt to partially underlie differences in outcomes. The objective of this study was to prospectively quantify blood levels of gut hormones of energy and glucose homeostasis at one year follow up to delineate possible reasons for greater efficacy of RYGB over SG in achieving weight loss., Methods: Patients undergoing SG (n = 19) and RYGB (n = 40) were studied before surgery and at 2,12, 26, and 52 weeks postoperatively. Blood samples drawn in the fasted state and after a liquid mixed meal were assayed at baseline, 26, and 52 weeks for peptide YY (PYY), glucagon-like peptide-1 (GLP-1), ghrelin, insulin, glucose, and leptin. Fasting and postprandial appetitive sensations were assessed by visual analog scale., Results: At 1 year there was greater weight loss in RYGB compared with SG patients (30% vs 27%; P = 0.03). Area under the curve (AUC) after the mixed meal for PYY was greater in RYGB patients (P<0.001). RYGB patients had significant increases in GLP-1 AUC compared to baseline (P = 0.002). Ghrelin levels decreased only after SG compared to baseline (P<0.001) but were not significantly different from RYGB. There was a trend toward decreased sweet cravings in RYGB patients (P = 0.056)., Conclusions: Differences in gastrointestinal hormones that regulate energy and glucose homeostasis are a possible mechanism for greater efficacy of RYGB compared to SG., Competing Interests: The authors have read the journal’s policy and have the following competing interests: JK participates on advisory boards for Digma Medical, GI Dynamics, and Esquagama. She receives financial compensation and stock options from GI Dynamics and Esqagama. She receives stock options from Digma Medical. She does not receive financial support via salary for her participation on these advisory boards. MB is a founder of Endobetes and has a patent application titled “Lumen Reinforcement and Anchoring System” application no. 16/046592. The patent is focused on a method to anchor devices in the GI tract and is assigned to Endobetes, a medical device startup with a goal of developing endoscopic devices for treatment of obesity and diabetes. MB owns stock in Endobetes and has an equity position, but does not receive financial support via salary as the founder of Endobetes. AK is a consultant for Intuitive Surgical, CLG, and CSATs. He was paid by Intuitive surgical to give several talks and serve as an OR surgery instructor/proctor. CLG is a third party consulting firm that connects firms with experts and AK was paid to offer an opinion on topics related to robotic surgery. He was paid by CSATs to review videos of surgeries and provide critique to the surgeons. He does not receive any financial support via salary or research funding from these firms. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Background: Roux-en-Y gastric bypass (RYGB) produces greater weight loss compared with a purely restrictive procedure such as laparoscopic adjustable gastric banding (LAGB)., Objective: The objective of this study was to quantify changes in hormones that regulate energy homeostasis and appetitive sensations before and after LAGB (n = 18) and RYGB (n = 38) in order to better understand the mechanisms underlying the greater weight loss after RYGB., Methods: A standardized test meal was administered prior to surgery, at 6 months, and annually thereafter to year 2 after LAGB and year 4 after RYGB. Blood samples were obtained in the fasted state and 30, 60, 90, and 120 min post-meal., Results: Progressive increases in fasting PYY were observed after RYGB together with increases in postprandial area under the curve (AUC) levels that were unchanged after LAGB. GLP-1 AUC increased only after RYGB. There was a weight loss-related increase in fasting ghrelin levels after LAGB that was unchanged 1 year after RYGB despite greater percentage weight loss; ghrelin subsequently increased at years 2-4 post-RYGB. HOMA-IR decreased after both procedures but correlated with weight loss only after LAGB, whereas leptin correlated with weight loss in both groups. Sweet cravings decreased after RYGB., Conclusion: A number of weight loss-independent changes in the gut hormonal milieu likely act in concert to promote a decrease in insulin resistance and greater weight loss efficacy after RYGB. A progressive change in hormone levels over time may reflect gut enteroplasticity after RYGB. A decrease in sweet cravings specific to RYGB may further promote superior weight loss outcomes.

Bariatric surgery is a treatment option for obese patients with type 2 diabetes mellitus (T2DM). Although sleeve gastrectomy (SG) is growing in favor, some randomized trials show less weight loss and HbA1c improvement compared with Roux-en-Y gastric bypass (RYGB). The study objective was to compare changes in beta-cell function with similar weight loss after SG and RYGB in obese patients with T2DM. Subjects undergoing SG or RYGB were studied with an intravenous glucose tolerance test before surgery and at 5-12% weight loss post-surgery. The primary endpoint was change in the disposition index (DI). Baseline BMI, HbA1c, and diabetes-duration were similar between groups. Mean total weight loss percent was similar (8.4% ± 0.4, p = 0.22) after a period of 21.0 ± 1.7 days. Changes in fasting glucose, acute insulin secretion (AIR), and insulin sensitivity (Si) were similar between groups. Both groups showed increases from baseline to post-surgery in DI (20.2 to 163.3, p = 0.03 for SG; 31.2 to 232.9, p = 0.02 for RYGB) with no significant difference in the change in DI between groups (p = 0.53). Short-term improvements in beta-cell function using an IVGTT were similar between SG and RYGB. It remains unclear if longer-term outcomes are better after RYGB due to greater weight loss and/or other factors.

Context: Roux-en-Y gastric bypass (RYGB) is associated with postprandial hyperinsulinemia., Objective: This study assessed whether increased blood insulin levels may be due to an increase in maximal β -cell function., Design Setting and Participants: We performed a cross-sectional study at Columbia University Medical Center, New York, New York. Subjects without a history of diabetes were studied after surgery (n = 12) and were compared with nonsurgical controls (n = 10) who were mean matched for body mass index, insulin sensitivity, and hemoglobin A1c and with nonobese controls (n = 8)., Methods: Subjects underwent a mixed-meal tolerance test and on a separate day an intravenous glucose tolerance test followed by a hyperglycemic clamp (450 mg/dL; 25 mM blood glucose) and arginine stimulation. The main outcome measure was maximal insulin secretion quantified after arginine stimulation (AinsRmax)., Results: The RYGB group exhibited greater peak postprandial glucose levels and fourfold greater peak insulin levels than control groups; however, there were no significant differences in insulinogenic index or AinsRmax. Another finding was significantly greater postprandial glucagon levels in the RYGB group compared with controls., Conclusions: Our results suggest that after RYGB, the increase in postprandial levels of insulin are not due to changes in maximal β -cell function but appear to be an appropriate response to altered nutrient flow and absorption.

We report a fatal case of Lassa fever diagnosed in the United States in a Liberian traveler. We describe infection control protocols and public health response. One contact at high risk became symptomatic, but her samples tested negative for Lassa virus; no secondary cases occurred among health care, family, and community contacts.