Magnetic single-anastomosis side-to-side duodeno-ileostomy for revision of sleeve gastrectomy in adults with severe obesity: 1-year outcomes.

INTRODUCTION: Uncomplicated surgical approaches that minimize anastomotic complications while improving revisional metabolic/bariatric surgical (MBS) outcomes are needed. METHODS: This prospective single-center study assessed the feasibility, safety, and efficacy of the novel linear magnetic anastomosis system (LMAS [3 cm]) in performing a side-to-side duodeno-ileostomy (MagDI) bipartition to revise clinically suboptimal primary sleeve gastrectomy (SG). Patients with severe obesity with/without type 2 diabetes (T2D) with suboptimal weight loss, regain, and/or T2D recurrence post SG underwent revisional MagDI. A distal and proximal magnet were delivered endoscopically to the ileum and duodenum and aligned via laparoscopic assistance. Gradual magnet fusion formed a DI bipartition. PRIMARY ENDPOINTS: technical feasibility, safety (Clavien-Dindo [CD] severe adverse event classification) at 1 year. Secondary endpoints: MBS weight and T2D reduction. RESULTS: July 29, 2022-March 28, 2023, 24 patients (95.8% female, mean age 44.9 ± 1.5 years, and body mass index [BMI] 39.4 ± 1.3 kg/m2) underwent MagDI. Feasibility was attained via correct magnet placement (mean operative time 63.5 ± 3.3 min), patent anastomoses created, and magnet passage per anus in 100.0% of patients. There were 4 CD-III mild or moderate severe AEs, 0.0% associated with the LMAS or MagDI: 0.0% anastomotic leakage, obstruction, bleeding, infection, reintervention, or death. Mean BMI reduction was 2.1 kg/m2 (p < 0.05); total weight loss 5.3%, excess weight loss 16.4%; and the patient with T2D improved. CONCLUSION: The single-anastomosis MagDI procedure using the novel 3-cm LMAS to revise clinically suboptimal SG was technically straightforward, incurred no major complications, mitigated weight regain, and renewed clinically meaningful weight loss. GOV IDENTIFIER: NCT05322122.

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.

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.

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).

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.

Systematic review and meta-analysis of medium-term outcomes after banded Roux-en-Y gastric bypass.

This is the first systematic review and meta-analysis focused exclusively on intermediate-term outcomes for the banded Roux-en-Y gastric bypass (B-RYGB). B-RYGB articles published from 1990 to 2013 were identified through MEDLINE, ScienceDirect, and SpringerLink databases augmented by manual reference review. Articles were assigned an evidence level (Centre for Evidence-Based Medicine [Oxford UK] criteria) and Jadad quality score (randomized controlled trials). Simple and weighted means (95% confidence interval (CI)) for excess weight loss (EWL) at follow-up (1-10+ years) were calculated. At 5 years, a pooled estimate for BMI (kg/m(2)) change (weighted mean difference and 95% CI) for banded bypass patients was computed. Rates for weighted mean complications, non-band- and band-related reoperations, and overall comorbidity resolution were calculated. Three hundred twenty-one articles were identified: 286 failed inclusion criteria (i.e., non-English, B-RYGB unrelated, <10 per arm, <3-year follow-up), leaving 35 articles. Manual review added 10 potentially relevant articles; 30 that failed inclusion criteria were excluded, leaving 15 for analysis. B-RYGB was performed on 8,707 patients: 79.0% female, mean age 38.7, and BMI 47.6 (41.0-59.4). Overall BMI weighted mean difference (reduction) at 5 years was 17.8 (95% CI 12.8, 22.7; p < 0.001). Five-year weighted mean EWL of 72.5% (67.5, 77.4) was sustained at 10+ years (69.4%; 58.9, 80.0). Weighted mean complication rates were as follows: early, 10.9%, and late, 20.0%. Non-band-related reoperation rate was 15.2%, and band-specific reoperation rate was 4.1%. Gastric outlet stenosis, band erosion, and band slippage were 2.8, 2.3, and 1.5%, respectively. Diabetes remitted in 80/95 (84.2%). By systematic review and meta-analysis, albeit with limited rates of follow-up, B-RYGB appeared to result in significant, sustained excess weight loss of approximately 70.0% out to 10 years.

Diabetes and weight in comparative studies of bariatric surgery vs conventional medical therapy: a systematic review and meta-analysis.

We performed a meta-analysis of weight loss and remission of type 2 diabetes mellitus (T2DM) evaluated in randomized controlled trials (RCTs) and observational studies of bariatric surgery vs conventional medical therapy. English articles published through June 10, 2013 that compared bariatric surgery with conventional therapy and included T2DM endpoints with ≥12-month follow-up were systematically reviewed. Body mass index (BMI, in kilogram per square meter), glycated hemoglobin (HbA1C, in degree), and fasting plasma glucose (FPG, in milligram per deciliter) were analyzed by calculating weighted mean differences (WMDs) and pooled standardized mean differences and associated 95 % confidence intervals (95 % CI). Aggregated T2DM remission event data were analyzed by calculating the pooled odds ratio (POR) and 95 % CI. Random effects assumptions were applied throughout; I(2) ≥ 75.0 % was considered indicative of significant heterogeneity. Systematic review identified 512 articles: 47 duplicates were removed, 446 failed inclusion criteria (i.e., n < 10 per arm, animal studies, reviews, case reports, abstracts, and kin studies). Of 19 eligible articles, two not focused on diagnosed T2DM and one with insufficient T2DM data were excluded. In the final 16 included papers, 3,076 patients (mean BMI, 40.9; age, 47.0; 72.0 % female) underwent bariatric surgery; 3,055 (39.4; 48.6, 69.0 %) received conventional or no weight-loss therapy. In bariatric surgery vs conventional therapy groups, the mean 17.3 ± 5.7 month BMI WMD was 8.3 (7.0, 9.6; p < 0.001; I(2) = 91.8), HbA(1C) was 1.1 (0.6, 1.6; p < 0.001; I(2) = 91.9), and FPG, 24.9 (15.9, 33.9; p < 0.001; I(2) = 84.8), with significant differences favoring surgery. The overall T2DM remission rate for surgery vs conventional group was 63.5 vs 15.6 % (p < 0.001). The Peto summary POR was 9.8 (6.1, 15.9); inverse variance summary POR was 15.8 (7.9, 31.4). Of the included studies, 94.0 % demonstrated a significant statistical advantage favoring surgery. In a meta-analysis of 16 studies (5 RCTs) with 6,131 patients and mean 17.3-month follow-up, bariatric surgery was significantly more effective than conventional medical therapy in achieving weight loss, HbA(1C) and FPG reduction, and diabetes remission. The odds of bariatric surgery patients reaching T2DM remission ranged from 9.8 to 15.8 times the odds of patients treated with conventional therapy.

Early experience with the Incisionless Operating Platform™ (IOP) for the treatment of obesity : the Primary Obesity Surgery Endolumenal (POSE) procedure.

BACKGROUND: We report our initial experience and 6-month outcomes in a single center using the per-oral Incisionless Operating Platform™ (IOP) (USGI Medical) to place transmural plications in the gastric fundus and distal body using specialized suture anchors (the Primary Obesity Surgery Endolumenal [POSE] procedure). METHODS: A prospective observational study was undertaken with institutional Ethics Board approval in a private hospital in Barcelona, Spain. Indicated patients were WHO obesity class I-II, or III, where patients refused a surgical approach. RESULTS: Between February 28, 2011 and March 23, 2012, the POSE procedure was successfully performed in 45 patients: 75.6 % female; mean age 43.4 ± 9.2 SD (range 21.0-64.0). At baseline: mean absolute weight (AW, kg), 100.8 ± 12.9 (75.5-132.5); body mass index (BMI, kg/m(2)), 36.7 ± 3.8 (28.1-46.6). A mean 8.2 suture-anchor plications were placed in the fundus, 3.0 along the distal body wall. Mean operative time, 69.2 ± 26.6 min (32.0-126.0); patients were discharged in <24 h. Six-month mean AW was 87.0 ± 10.3 (68.0-111.5); BMI decreased 5.8 to 31.3 ± 3.3 (25.1-38.6) (p < 0.001); EWL was 49.4 %; TBWL, 15.5 %. No mortality or operative morbidity. Minor postoperative side effects resolved with treatment by discharge. Patients reported less hunger and earlier satiety post procedure. Liquid intake began 12 h post procedure with full solids by 6 weeks. CONCLUSIONS: At 6-month follow-up of a prospective case series, the POSE procedure appeared to provide safe and effective weight loss without the scarring, pain, and recovery issues of open and laparoscopic bariatric surgery. Long-term follow-up and further study are required.