First-in-Human Side-to-Side Magnetic Compression Duodeno-ileostomy with the Magnet Anastomosis System.

PURPOSES: Classical gastrointestinal anastomoses are formed with sutures and/or metal staples, resulting in significant bleeding and leak rates. This study evaluated the feasibility and safety of the novel magnet anastomosis system (MS) to create a side-to-side duodeno-ileal (DI) diversion for weight loss and type 2 diabetes (T2D) resolution. MATERIALS AND METHODS: Patients with severe obesity (body mass index (BMI) ≥ 35 kg/m2 with/without T2D (HbA1C ≥ 6.5%)) underwent the study procedure, a side-to-side MS DI diversion, with a standard sleeve gastrectomy (SG). A linear magnet was delivered by flexible endoscopy to a point 250 cm proximal to the ileocecal valve; a second magnet was positioned in the first part of the duodenum; the bowel segments containing magnets were apposed, initiating gradual anastomosis formation. Laparoscopic assistance was used to obtain bowel measurements, obviate tissue interposition, and close mesenteric defects. RESULTS: Between November 22 and 26, 2021, 5 female patients (mean weight 117.6 ± 7.1 kg, BMI (kg/m2) 44.4 ± 2.2) underwent side-to-side MS DI + SG. All magnets were successfully placed, expelled without re-intervention, and formed patent durable anastomoses. Total weight loss at 12 months was 34.0 ± 1.4% (SEM); excess weight loss, 80.2 ± 6.6%; and BMI reduction, 15.1. Mean HbA1C (%) dropped from 6.8 ± 0.8 to 4.8 ± 0.2; and glucose (mg/dL), from 134.3 ± 17.9 to 87.3 ± 6.3 (mean reduction, 47.0 mg/dL). There was no anastomotic bleeding, leakage, obstruction, or infection and no mortality. CONCLUSIONS: Creation of a side-to-side magnetic compression anastomosis to achieve duodeno-ileostomy diversion in adults with severe obesity was feasible and safe, achieved excellent weight loss, and resolved type 2 diabetes at 1-year follow-up. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT05322122.

Side-to-side duodeno-ileal magnetic compression anastomosis: design and feasibility of a novel device in a porcine model.

BACKGROUND: Minimally invasive metabolic/bariatric surgery (MBS) may be further advanced by magnetic compression anastomosis (MCA) technology. The study aimed to develop a magnet sized to create a patent duodeno-ileostomy (DI) and verify its effectiveness in a porcine model. METHODS: Developmental study phase: magnets with 4 different flange-offset dimensions were tested to identify a design that would successfully form a compression anastomosis. Verification phase: evaluation of the selected design's efficacy. In each 6-week phase (4 pigs/phase), one magnet was inserted laparoscopically in the jejunum, one placed gastroscopically in the duodenum. Magnets were aligned, gradually fused, formed an anastomosis, and then detached and were expelled. At necropsy, MCA sites and sutured enterotomy sites were collected and compared. RESULTS: Developmental phase: the linear BC42 magnet with a 2.3-mm flange offset design was selected. Verification phase: in 4 swine magnets were mated at the target location, confirmed radiographically. Mean time to magnet detachment 16.0 days (12-22), to expulsion 24.5 days (17-33). MCA was achieved in all animals at time of sacrifice. Animals gained a mean 9.5 kg (3.9-11.8). Specimens revealed patent anastomoses of ≥ 20 mm with smooth mucosa and minimal inflammation and fibrosis compared to sutured enterotomies. One pig underwent corrective surgery for a mesenteric hernia without sequelae. CONCLUSION: In a large-animal model, gross and histopathologic examination confirmed that the linear MCA device created a patent, well-vascularized, duodeno-ileal anastomosis. The novel MCA device may be appropriate for use in human MBS procedures.

Side-to-side magnet anastomosis system duodeno-ileostomy with sleeve gastrectomy: early multi-center results.

INTRODUCTION: Gastrointestinal anastomoses with classical sutures and/or metal staples have resulted in significant bleeding and leak rates. This multi-site study evaluated the feasibility, safety, and preliminary effectiveness of a novel linear magnetic compression anastomosis device, the Magnet System (MS), to form a side-to-side duodeno-ileostomy (DI) diversion for weight loss and type 2 diabetes (T2D) resolution. METHODS: In patients with class II and III obesity (body mass index [BMI, kg/m2] ≥ 35.0- ≤ 50.0 with/without T2D [HbA1C > 6.5%]), two linear MS magnets were delivered endoscopically to the duodenum and ileum with laparoscopic assistance and aligned, initiating DI; sleeve gastrectomy (SG) was added. There were no bowel incisions or retained sutures/staples. Fused magnets were expelled naturally. Adverse events (AEs) were graded by Clavien-Dindo Classification (CDC). RESULTS: Between November 22, 2021 and July 18, 2022, 24 patients (83.3% female, mean ± SEM weight 121.9 ± 3.3 kg, BMI 44.4 ± 0.8) in three centers underwent magnetic DI. Magnets were expelled at a median 48.5 days. Respective mean BMI, total weight loss, and excess weight loss at 6 months (n = 24): 32.0 ± 0.8, 28.1 ± 1.0%, and 66.2 ± 3.4%; at 12 months (n = 5), 29.3 ± 1.5, 34.0 ± 1.4%, and 80.2 ± 6.6%. Group mean respective mean HbA1C and glucose levels dropped to 1.1 ± 0.4% and 24.8 ± 6.6 mg/dL (6 months); 2.0 ± 1.1% and 53.8 ± 6.3 mg/dL (12 months). There were 0 device-related AEs, 3 procedure-related serious AEs. No anastomotic bleeding, leakage, stricture, or mortality. CONCLUSION: In a multi-center study, side-to-side Magnet System duodeno-ileostomy with SG in adults with class III obesity appeared feasible, safe, and effective for weight loss and T2D resolution in the short term.

A Randomized Controlled Trial of Acid and Bile Reflux Esophagitis Prevention by Modified Fundoplication of the Excluded Stomach in One-Anastomosis Gastric Bypass: 1-Year Results of the FundoRing Trial.

BACKGROUND: The advantages and disadvantages of one-anastomosis gastric bypass (OAGB) with primary modified fundoplication using the excluded stomach ("FundoRing") is unclear. We aimed to assess the impact of this operation in a randomized controlled trial (RCT) and answer the next questions: (1) What the impact of wrapping the fundus of the excluded part of the stomach in OAGB on protection in the experimental group against developing de novo reflux esophagitis? (2) If preoperative RE could be improved in the experimental group? (3) Can preoperative acid reflux as measured by PH impedance, be treated by the addition of the "FundoRing"? METHODS: The study design was a single-center prospective, interventional, open-label (no masking) RCT (FundoRing Trial) with 1-year follow-up. Endpoints were body mass index (BMI, kg/m2) and acid and bile RE assessed endoscopically by Los Angeles (LA) classification and 24-h pH impedance monitoring. Complications were graded by Clavien-Dindo classification (CDC). RESULTS: One hundred patients (n = 50 FundoRingOAGB (f-OAGB) vs n = 50 standard OAGB (s-OAGB)) with complete follow-up data were included in the study. During OAGB procedures, patients with hiatal hernia underwent cruroplasty (29/50 f-OAGB; 24/50 s-OAGB). There were no leaks, bleeding, or deaths in either group. At 1 year, BMI in the f-OAGB group was 25.3 ± 2.77 (19-30) vs 26.48 ± 2.8 (21-34) s-OAGB group (p = 0.03). In f-OAGB vs s-OAGB groups, respectively, acid RE was seen in 1 vs 12 patients (p = 0.001) and bile RE in 0 vs 4 patients (p < 0.05). CONCLUSION: Routine use of a modified fundoplication of the OAGB-excluded stomach to treat patients with obesity decreased acid and prevented bile reflux esophagitis significantly more effectively than standard OAGB at 1 year in a randomized controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04834635.

Long-term Reported Outcomes Following Primary Laparoscopic Sleeve Gastrectomy.

BACKGROUND: Long-term laparoscopic sleeve gastrectomy (LSG) outcomes in patients with obesity are scarce. We aimed to examine the outcomes and subjective experience of patients who underwent primary LSG with long-term follow-up. METHODS: The study is a retrospective observational analysis of patients who underwent primary LSG in a single center with 5-15 years of follow-up. Patients' hospital chart data supplemented by a detailed follow-up online questionnaire and telephone interview were evaluated. RESULTS: The study sample included 578 patients (67.0% female) with 8.8 ± 2.5 years of mean follow-up, with a response rate to the survey of 82.8%. Mean baseline age and body mass index (BMI) were 41.9 ± 10.6 years and 42.5 ± 5.5 kg/m2, respectively. BMI at nadir was 27.5 ± 4.9 kg/m2, corresponding to a mean excess weight loss (EWL) of 86.9 ± 22.8%. Proportion of patients with weight regain, defined as nadir ≥ 50.0% EWL, but at follow-up < 50.0% EWL, was 34.6% (n = 200) and the mean weight regain from nadir was 13.3 ± 11.1 kg. BMI and EWL at follow-up were 32.6 ± 6.4 kg/m2 and 58.9 ± 30.1%, respectively. The main reasons for weight regain given by patients included "not following guidelines," "lack of exercise," "subjective impression of being able to ingest larger quantities of food in a meal," and "not meeting with the dietitian." Resolution of obesity-related conditions at follow-up was reported for hypertension (51.7%), dyslipidemia (58.1%) and type 2 diabetes (72.2%). The majority of patients (62.3%) reported satisfaction with LSG. CONCLUSIONS: In the long term, primary LSG was associated with satisfactory weight and health outcomes. However, weight regain was notable.

Original contribution: sleeve gastrectomy reduces soluble lectin-like oxidized low-density lipoprotein receptor-1 (sLOX-1) levels in patients with morbid obesity.

BACKGROUND: Early diagnosis of subclinical cardiovascular disease (CVD) in patients with morbid obesity is important. We investigated the effects of sleeve gastrectomy (SG) on serum soluble lectin-like oxidized low-density lipoprotein receptor-1 (sLOX-1), oxidized LDL (oxLDL), and other metabolic and inflammatory parameters associated with atherosclerosis in patients with morbid obesity. METHODS: Body mass index (BMI) measurements and assays of metabolic and inflammatory markers were taken in patients in an SG surgery group and a healthy control group and compared at baseline and 12 months after SG. Correlations with changes in these parameters and variations in sLOX-1 were analyzed. RESULTS: Metabolic and inflammatory marker values in the surgery (n = 20) and control (n = 20) groups were significantly different at baseline (p < 0.001). The majority of surgery group biomarker levels significantly decreased with mean BMI loss (- 11.8 ± 9.0, p < 0.001) at 12 months, trending toward control group values. Baseline albumin level as well as percentage reductions in oxLDL and the cholesterol retention fraction (CRF) were found to be significantly correlated with percentage reduction in sLOX-1 at 12 months following SG. CONCLUSION: Metabolic and inflammatory biomarkers elevated at baseline significantly decreased after SG weight loss. Weight loss induced by SG may limit endothelial damage by reducing levels of oxLDL and LOX-1 as assessed by sLOX-1. These findings suggest that sLOX-1 may function as a marker of atherosclerotic disease states in patients with morbid obesity and that metabolic/bariatric surgery can play a meaningful role in CVD prevention.

Automated summative feedback improves performance and retention in simulation training of mastoidectomy: a randomised controlled trial.

OBJECTIVE: This study aimed to investigate the effects of automated metrics-based summative feedback on performance, retention and cognitive load in distributed virtual reality simulation training of mastoidectomy. METHOD: Twenty-four medical students were randomised in two groups and performed 15 mastoidectomies on a distributed virtual reality simulator as practice. The intervention group received additional summative metrics-based feedback; the control group followed standard instructions. Two to three months after training, participants performed a retention test without learning supports. RESULTS: The intervention group had a better final-product score (mean difference = 1.0 points; p = 0.001) and metrics-based score (mean difference = 12.7; p < 0.001). At retention, the metrics-based score for the intervention group remained superior (mean difference = 6.9 per cent; p = 0.02). Also at the retention, cognitive load was higher in the intervention group (mean difference = 10.0 per cent; p < 0.001). CONCLUSION: Summative metrics-based feedback improved performance and lead to a safer and faster performance compared with standard instructions and seems a valuable educational tool in the early acquisition of temporal bone skills.

Stapleless vs Stapled Gastric Bypass vs Hypocaloric Diet: a Three-Arm Randomized Controlled Trial of Body Mass Evolution with Secondary Outcomes for Telomere Length and Metabolic Syndrome Changes.

BACKGROUND: Obesity and metabolic syndrome (MetS) reduce life expectancy and are challenging to resolve. This randomized controlled trial (RCT) of patients with obesity and MetS undergoing surgical vs nonsurgical treatment compared changes in BMI, and secondarily, telomere length (as a biomarker of life expectancy) and changes in MetS components (insulin resistance, dyslipidemia, hypertension). METHODS: Study design was a single-center, prospective, three-arm RCT. Group 1 patients underwent novel unstapled laparoscopic one anastomosis gastric bypass with an obstructive stapleless pouch and anastomosis (LOAGB-OSPAN); Group 2, stapled laparoscopic mini-gastric bypass-one anastomosis gastric bypass (LMGB-OAGB); and Group 3, nonsurgical weight loss therapy via a hypocaloric diet with energy restriction (HDER). The primary outcome measure was change in BMI; secondary outcome measures included change in leukocyte telomere length and other MetS components. RESULTS: Of 96 participants screened, 60 were randomly allocated to 3 groups: LOAGB-OSPAN group (n = 20), LMGB-OAGB group (n = 20), and HDER group (n = 20). At post-treatment month 12, respective BMI changes: BMI -12.13 (-8.34, -15.93); -16.04 (-11.7, 20.37); -2,76 (-3.84, -9.36) (p < 0.01). The two surgical groups experienced significant change in telomere length: LOAGB-OSPAN 2.02 (1.61, 2.41), p = 0.001; LMGB-OAGB 2.07 (1.72, 2.43), p = 0.001; and HDER 0.28 (0.22, 0.78), p = 0.26. The surgical groups were also more effective in treating MetS components. There were no deaths. Adverse events: LOAGB-OSPAN (n = 2) (Clavien-Dindo grade II); LMGB-OAGB (n = 8) (grade I (n = 6) and grade II (n = 2). CONCLUSIONS: Compared with hypocaloric diet therapy, both bariatric procedures resulted in greater BMI loss, and secondarily, a significant increase in telomere length, and greater MetS resolution. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03667469, registered on 11 September 2018.

PART 3 Bypassing TBI: Metabolic Surgery and the Link Between Obesity and Traumatic Brain Injury-a Review.

Obesity is a common outcome of traumatic brain injury (TBI) that exacerbates principal TBI symptom domains identified as common areas of post-TBI long-term dysfunction. Obesity is also associated with increased risk of later-life dementia and Alzheimer's disease. Patients with obesity and chronic TBI may be more vulnerable to long-term mental abnormalities. This review explores the question of whether weight loss induced by bariatric surgery could delay or perhaps even reverse the progression of mental deterioration. Bariatric surgery, with its induction of weight loss, remission of type 2 diabetes, and other expressions of the metabolic syndrome, improves metabolic efficiency, leads to reversal of brain lesions seen on imaging studies, and improves function. These observations suggest that metabolic/bariatric surgery may be a most effective therapy for TBI.

Part 2: Bypassing TBI-Metabolic Surgery and the Link Between Obesity and Traumatic Brain Injury-A Review.

Obesity is a common outcome of traumatic brain injury (TBI) that exacerbates principal TBI symptom domains identified as common areas of post-TBI long-term dysfunction. Obesity is also associated with increased risk of later-life dementia and Alzheimer's disease. Patients with obesity and chronic TBI may be more vulnerable to long-term mental abnormalities. This review explores the question of whether weight loss induced by bariatric surgery could delay or perhaps even reverse the progression of mental deterioration. Bariatric surgery, with its induction of weight loss, remission of type 2 diabetes, and other expressions of the metabolic syndrome, improves metabolic efficiency, leads to reversal of brain lesions seen on imaging studies, and improves function. These observations suggest that metabolic/bariatric surgery may be the most effective therapy for TBI.

Bypassing TBI: Metabolic Surgery and the Link between Obesity and Traumatic Brain Injury-a Review.

Obesity is a common outcome of traumatic brain injury (TBI) that exacerbates principal TBI symptom domains identified as common areas of post-TBI long-term dysfunction. Obesity is also associated with increased risk of later-life dementia and Alzheimer's disease. Patients with obesity and chronic TBI may be more vulnerable to long-term mental abnormalities. This review explores the question of whether weight loss induced by bariatric surgery could delay or perhaps even reverse the progression of mental deterioration. Bariatric surgery, with its induction of weight loss, remission of type 2 diabetes, and other expressions of the metabolic syndrome, improves metabolic efficiency, leads to reversal of brain lesions seen on imaging studies, and improves function. These observations suggest that metabolic/bariatric surgery may be a most effective therapy for TBI.

5-Year Results of Banded One-Anastomosis Gastric Bypass: a Pilot Study in Super-Obese Patients.

BACKGROUND: The novel banded one-anastomosis gastric bypass (B-OAGB) procedure has not previously been reported in super-obese patients over the long term. In this pilot study, outcomes in patients with a mean baseline body mass index (BMI, kg/m2) of ≥ 50 who underwent B-OAGB were evaluated through 5-year follow-up. PATIENTS AND METHODS: Total weight loss (TWL), excess weight loss (EWL), BMI evolution, and changes in type 2 diabetes biomarkers were analyzed prospectively in super-obese patients who underwent B-OAGB. Paired samples t tests were used to assess weight outcome change from baseline through 5-year follow-up and 95% CIs were calculated. The Bariatric Outcomes and Reporting System (BAROS) was used to assess surgical success at 3 time points. RESULTS: Between October 2013 and February 2014, a 12-patient pilot cohort (mean baseline BMI 57.5 ± 6.3) underwent B-OAGB. No perioperative complications were observed within 30 days. Five-year mean BMI was 31.2 ± 5.4, a BMI loss of 25.9 (TWL 45.3 ± 7.5%; EWL 72.2 ± 12.8%). Between 11 and 24 months following surgery, 3 patients required band removal; each had one complication (1 stasis esophagitis and recurrent vomiting; 1 hypoalbuminemia; 1 anemia). There was no mortality. Long-term B-OAGB BAROS subscale and composite scores were comparable to other major bariatric procedures. CONCLUSIONS: In a pilot study of super-obese patients who underwent B-OAGB, excellent durable BMI loss of 25.9 kg/m2 (EWL 72.2%) at 5 years was achieved with an acceptable level of reoperation. More B-OAGB long-term follow-up studies are necessary to provide definitive conclusions regarding this combination bariatric procedure.

Machine Perfusion: Cold versus Warm, versus Neither. Update on Clinical Trials.

Machine perfusion (MP) preservation is potentially one of the most significant improvements in the field of liver transplantation in the last 20 years, and it has been considered a promising strategy for improved preservation and ex situ evaluation of extended criteria donor (ECD) organs. However, MP preservation adds significant cost and logistical considerations to liver transplantation. MP protocols are mainly classified according to the perfusion temperature with hypothermic machine perfusion (HMP) and normothermic machine perfusion (NMP) being the two categories most studied so far. After extensive preclinical work, MP entered the clinical setting, and there are now several studies that demonstrated feasibility and safety. However, because of the limited quality of clinical trials, there is no compelling evidence of superiority in preservation quality, and liver MP is still considered experimental in most countries. MP preservation is moving to a more mature phase, where ongoing and future studies will bring new evidence in order to confirm their superiority in terms of clinical outcomes, organ utilization, and cost-effectiveness. Here, we present an overview of all preclinical MP studies using discarded human livers and liver MP clinical trials, and discuss their results. We describe the different perfusion protocols, pitfalls in MP study design, and provide future perspectives. Recent trials in liver MP have revealed unique challenges beyond those seen in most clinical studies. Randomized trials, correct trial design, and interpretation of data are essential to generate the data necessary to prove if MP will be the new gold standard method of liver preservation.

Executive Summary: Collected Papers of the American College of Surgeons Metabolic Surgery Symposium.

On August 9-10, 2017, the American College of Surgeons hosted a symposium on metabolic surgery, with 12 follow-on papers published serially in the Bulletin of the College. The current synopsis outlines the varied contents of these papers, often in the original words of their authors, who are cited within their topic sections. Topics covered include the following: history and definition of metabolic surgery, bariatric surgery, international bariatric surgery, mechanisms of metabolic surgery, diabetes and the metabolic syndrome, frontiers of metabolic surgery, institutional collaborations, accreditations and quality initiatives, professional training, the role of the National Institutes of Health, and advocacy. Based on these insights, an enthusiastic affirmation for the future of metabolic surgery is warranted.

Laparoscopic One-Anastomosis Gastric Bypass with Band-Separated Gastric Pouch (OAGB-BSGP): a Randomized Controlled Trial.

BACKGROUND: One-anastomosis gastric bypass with band-separated gastric pouch (OAGB-BSGP) is a novel "staplerless" version of OAGB. This randomized controlled trial (RCT) compared 2-year outcomes for OAGB-BSGP and standard OAGB. METHODS: The parallel-group RCT randomly allocated patients to group A, staplerless OAGB-BSGP, or group B, stapled OAGB. RESULTS: Respective mean values for groups A and B (n = 40 each): baseline body mass index (BMI, kg/m2), 40.6 ± 5.6 vs 41.2 ± 6.4 (p = 0.64); abdominal bleeding (mL), 5.9 ± 8.0 vs 31.1 ± 30.5 (p < 0.0001). Two-year outcomes: BMI, 26.3 ± 3.2 vs 29.0 ± 4.7; %TWL, 34.1 ± 9.0 vs 29.3 ± 10.6, p < 0.03; %EBMIL, 94.3 ± 23.6 vs 77.9 ± 29.3, p < 0.007; bile reflux, n = 1 (2.5%) vs n = 7 (17.5%) (p = 0.05); revisions, n = 0 vs n = 4 (10.0%), p = 0.12. CONCLUSIONS: At 2-year RCT follow-up, staplerless OAGB-BSGP patients had fewer complications, no revisions, and greater weight loss than stapled OAGB patients. TRIAL REGISTRATION: ISRCTN56106651 (OSPAN-RCT).

Growth of vertically aligned nanowires in metal-oxide nanocomposites: kinetic Monte-Carlo modeling versus experiments.

We employ kinetic Monte-Carlo simulations to study the growth process of metal-oxide nanocomposites obtained via sequential pulsed laser deposition. Using Ni-SrTiO3 (Ni-STO) as a model system, we reduce the complexity of the computational problem by choosing a coarse-grained approach mapping Sr, Ti and O atoms onto a single effective STO pseudo-atom species. With this ansatz, we scrutinize the kinetics of the sequential synthesis process, governed by alternating deposition and relaxation steps, and analyze the self-organization propensity of Ni atoms into straight vertically aligned nanowires embedded in the surrounding STO matrix. We finally compare the predictions of our binary toy model with experiments and demonstrate that our computational approach captures fundamental aspects of self-assembled nanowire synthesis. Despite its simplicity, our modeling strategy successfully describes the impact of relevant parameters like the concentration or laser frequency on the final nanoarchitecture of metal-oxide thin films grown via pulsed laser deposition.

An epigenome-wide association study meta-analysis of educational attainment.

The epigenome is associated with biological factors, such as disease status, and environmental factors, such as smoking, alcohol consumption and body mass index. Although there is a widespread perception that environmental influences on the epigenome are pervasive and profound, there has been little evidence to date in humans with respect to environmental factors that are biologically distal. Here we provide evidence on the associations between epigenetic modifications-in our case, CpG methylation-and educational attainment (EA), a biologically distal environmental factor that is arguably among the most important life-shaping experiences for individuals. Specifically, we report the results of an epigenome-wide association study meta-analysis of EA based on data from 27 cohort studies with a total of 10 767 individuals. We find nine CpG probes significantly associated with EA. However, robustness analyses show that all nine probes have previously been found to be associated with smoking. Only two associations remain when we perform a sensitivity analysis in the subset of never-smokers, and these two probes are known to be strongly associated with maternal smoking during pregnancy, and thus their association with EA could be due to correlation between EA and maternal smoking. Moreover, the effect sizes of the associations with EA are far smaller than the known associations with the biologically proximal environmental factors alcohol consumption, body mass index, smoking and maternal smoking during pregnancy. Follow-up analyses that combine the effects of many probes also point to small methylation associations with EA that are highly correlated with the combined effects of smoking. If our findings regarding EA can be generalized to other biologically distal environmental factors, then they cast doubt on the hypothesis that such factors have large effects on the epigenome.

Five-Year Outcomes: Laparoscopic Greater Curvature Plication for Treatment of Morbid Obesity.

BACKGROUND: Laparoscopic greater curvature plication (LGCP) is a newer metabolic/bariatric surgical procedure that requires no resection, bypass, or implantable device. We report outcomes in a cohort of LGCP patients at 5-year follow-up. METHODS: Body mass index (BMI, kg/m2) evolution, excess weight loss (%EWL), excess BMI loss (%EBMIL), and total weight loss (%TWL) were recorded. Repeated measures analysis of variance (ANOVA) was used to assess BMI change over 5 years. Two-step cluster analysis was used to profile LGCP patients according to significant characteristics relative to successful 5-year weight loss. RESULTS: Of patients entering the study between 2010 and 2011 with complete weight data through 5-year follow-up (86.9%, 212/244), mean age was 45.8 ± 10.9 years; mean baseline BMI, 41.4 ± 5.5 (81.6% women); 58 patients (27.4%) had type 2 diabetes. Mean operative time was 69.0 min; mean hospitalization, 38 h (24-72). ANOVA indicated a significant BMI reduction out to 2 years (p < 0.001), a plateau at 3 and 4 years, and a moderate but significant BMI increase at 5 years (p < 0.01). EBMIL at 1, 2, 3, 4, and 5 years was as follows: 50.7 ± 9.1%, 61.5 ± 8.1%, 60.2 ± 7.0%, 58.5 ± 7.0%, and 56.8 ± 6.3%. At 5 years, 79.2% (168/212) of patients were successful; 20.8% (44/212) experienced a suboptimal weight outcome; mean weight regain, 9.2%. Cluster analysis identified four distinct LGCP patient profiles. Diabetes improvement rate was 65.5%. There were 12 reoperations (4.9%): 4 emergency (1.6%) and 8 (3.3%) elective. There was no mortality. CONCLUSIONS: At 5-year follow-up, LGCP proved to be safe and effective, with 56.8% EBMIL and a low rate of complications.

MILEPOST Multicenter Randomized Controlled Trial: 12-Month Weight Loss and Satiety Outcomes After pose SM vs. Medical Therapy.

BACKGROUND: Pose SM is an endolumenal weight-loss intervention in which suture anchors are placed endoscopically in the gastric fundus/distal gastric body. Observational studies of pose have shown safe, effective weight loss. Twelve-month results of a randomized controlled trial comparing weight loss and satiety after pose vs. conventional medical therapy are reported. METHODS: Subjects with classes I-II obesity were randomized in a 3:1 ratio to pose or diet/exercise guidance only (control). Pose subjects received gastric fundus and distal body suture-anchor plications with diet/exercise counseling. Total body (%TBWL) and excess weight loss (%EWL) were assessed at 6 and 12 months. Analysis of covariance (ANCOVA) was used to analyze 12-month %TBWL. Satiety changes were assessed at 6 and 12 months. RESULTS: From November 2013 to July 2014, 44 subjects were randomized (34, 77.3 % female; mean age, 38.3 ± 10.7 years; body mass index, 36.5 ± 3.4 kg/m2) to pose (n = 34) or control (n = 10) groups in three centers. Mean pose procedure time was 51.8 ± 14.5 min; pose subjects received a mean 8.8 ± 1.3 fundal and 4.2 ± 0.7 distal body plications. Twelve-month TBWL: pose, 13.0 % (EWL, 45.0 %), n = 30 vs. control group, 5.3 % (18.1 %), n = 9; significant mean difference, 7.7 % (95 % CI 2.2, 13.2; p < 0.01). Pose subjects showed significant reductions in satiety parameters (p < 0.001); controls experienced reduced caloric intake and satiety volume (p < 0.05). No serious device- or procedure-related adverse events occurred. CONCLUSIONS: In a randomized controlled trial at 12 months, pose-treated subjects had significantly greater weight loss than those treated with diet/exercise guidance alone. At 6 and 12 months, pose subjects showed significant reduction in satiety parameters. STUDY REGISTRATION: clinicaltrials.gov identifier # NCT01843231.

Gastrointestinal Physiological Changes and Their Relationship to Weight Loss Following the POSE Procedure.

BACKGROUND: Primary Obesity Surgery Endolumenal (POSE) is a novel bariatric endoscopic procedure that has been shown to reduce weight safely through 12 months. The study investigated potential mechanisms of weight loss following POSE. METHODS: Patients with class I-II obesity received transmural plications in the gastric fundus and distal gastric body. Patients were evaluated at baseline and at 2- and 6-month follow-up with gastric-emptying (GE) scintigraphy, a validated test of intake capacity (kcal) and plasma glucose homeostasis hormones/gastrointestinal peptides. Weight was recorded through 15 months. Mean data and 95% CIs are reported. Regression modeling assessed variables that influenced total weight loss (%TWL) and excess weight loss (%EWL). RESULTS: POSE was performed on 18 patients (14 F/4 M); mean age 39 years (34-44), body mass index (BMI, kg/m(2)) 36 (95% CI, 35; 37). At 15 months (n = 15), mean TWL was 19.1 ± 6.6% (15.5; 22.8) and EWL was 63.7 ± 25.1% (49.8; 77.6). At 2 and 6 months (n = 18), intake capacity decreased significantly from 901 (685; 1117) to 473 (345; 600) and 574 kcal (418; 730), respectively (p < 0.001). At 2 months, GE was delayed but returned to baseline levels at 6 months (n = 18). Glucose/insulin ratio improved (p < 0.05). Postprandial decrease in ghrelin was enhanced (p = 0.03) as well as postprandial increase in PYY (p = 0.001). The best model for EWL prediction 15 months after POSE (R (2): 66%, p = 0.006) included pre-POSE BMI, post-POSE GE, and postprandial PYY increase. CONCLUSIONS: The POSE procedure was followed by significant sustained weight loss and improved glucose homeostasis and satiation peptide responses. Weight loss following POSE may be mediated through changes in gastrointestinal neuro-endocrine physiology.