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Less invasive and safer anastomotic techniques are desirable. We aimed to determine technical feasibility and safety of sutureless duodeno-ileal side-to-side anastomosis in obese patients using self-assembling magnets. This was an open-label, prospective, and single-arm study including obese patients (BMI 30–50 kg/m2) with type II diabetes. The ileal magnet was deployed laparoscopically, and the duodenal magnet was deployed endoscopically. Both magnets were coupled under laparoscopic and fluoroscopic guidance. The primary endpoints were technical feasibility and safety. The secondary endpoints were patency of the anastomosis, HbA1c reduction, and weight loss 12 months after the procedure. A total of 8 patients were enrolled in the study; median age was 51.5 years (range: 34–65), and median BMI was 38.8 kg/m2 (range: 35–47.9). The mean procedural duration was 63.5 min (range: 41–95). No intraoperative complications were recorded, and no major postoperative morbidity related to the procedure occurred. Magnets were expelled at a median of 29.5 days after the procedure with no associated complications. Upper endoscopy at 12 months confirmed patent anastomoses with healthy-appearing mucosa in all patients. HbA1c reduced below 7.0% in 6 out of 8 (75%) patients, and greater than 5% of total body weight loss was observed in 7 out of 8 (87.5%) patients at 12 months. Sutureless duodeno-ileal side-to-side anastomosis using self-assembling magnets is feasible and safe in obese patients, and a dual-path enteral diversion with large-caliber and durable anastomosis can be achieved.

There is a growing interest in minimally invasive endoscopic gallbladder drainage therapies. Unlike stenting, a technology based on magnetic compression could theoretically produce a durable drainage anastomosis without residual foreign material. This study aimed to evaluate the safety and technical feasibility of a cholecysto-duodenal magnetic compression anastomosis.We performed a survival study of two Yorkshire pigs. Duodenal magnets were deployed endoscopically; reciprocal gallbladder magnets were placed laparoscopically, and the magnets were coupled. Pigs underwent serial endoscopy documenting magnet expulsion and evolution of cholecysto-duodenal anastomosis creation. Necropsies and histological evaluation were performed. Primary endpoints were technical success and safety. Secondary endpoints included anastomosis integrity, patency, and histologic characteristics.Magnets were successfully delivered and coupled. Patent, leak-free anastomoses formed by day 4. Magnets were expelled by day 10. All anastomoses were widely patent at one month (mean diameter 15 mm). Necropsy showed the absence of adhesions affecting the anastomosis. Histology showed complete re-epithelialization without inflammation or foreign body reaction.Magnetic cholecysto-duodenal anastomosis for gallbladder drainage appears safe and feasible in the animal model. The anastomoses are patent, leak-free, and without inflammation from the presence of foreign material. Technical modifications for magnet delivery under endoscopic ultrasound (EUS) guidance are currently underway.

Background and Aims Most patients with type 2 diabetes mellitus have obesity. Studies show that bariatric surgery is superior to medical treatment for remission of type 2 diabetes mellitus. Nevertheless, very few patients undergo surgery, and a less-invasive endoscopic alternative is desirable. Methods This was a single-arm first-in-human pilot study designed to evaluate the technical feasibility, safety, and clinical performance of the incisionless magnetic anastomosis system (IMAS) to create a partial jejunal diversion (PJD). Ten patients with obesity and type 2 diabetes mellitus, prediabetes, or no diabetes were enrolled. A PJD to the ileum was attempted in all patients under general anesthesia. The IMAS was delivered through the working channel of a colonoscope, with laparoscopic supervision. The patients were not required to participate in an intensive lifestyle/diet management program. Endoscopic visualization of the anastomosis was obtained at 2, 6, and 12 months. Patient weight, glycemic profile, and metabolic panels were acquired at 0.5, 1, 2, 3, 6, 9, and 12 months. Results A PJD was created in all patients with no device-related serious adverse events. The anastomosis remained widely patent in all patients at 1 year. Average total weight loss was 14.6% (40.2% excess weight loss at 12 months). A significant reduction in glycated hemoglobin level was observed in all diabetic (1.9%) and prediabetic (1.0%) patients, while reducing or eliminating the use of diabetes medications. Conclusions Permanent anastomosis for PJD was created in all patients with the IMAS. This resulted in improvement in measures of hyperglycemia and progressive weight loss. (Clinical trial registration number: NCT02839512.)

Background Retrograde intussusception (RI) at the jejunojejunostomy can occur after Roux-en-Y gastric bypass (RYGB). Although this complication is rare, it has been encountered more frequently as the number of bariatric procedures have increased. Little data is available to assist surgeons with the optimal management of this condition. Our objectives were to identify the risk factors for RI after RYGB and report on outcomes after surgical intervention at a tertiary academic surgical unit. Methods We used our prospective longitudinal institutional bariatric surgical database to identify patients with post-RYGB RI from 1996 to 2011. Results We identified 28 post-RYGB RI cases. The median interval between RYGB and RI was 52 months, and the median percentage of excess weight loss was 75%. Patients presented with acute symptoms in 36% of the cases. All patients underwent surgical exploration, including resection and revision of the jejunojejunostomy (46%) or operative reduction with or without enteropexy (54%). Those undergoing resection had a longer hospital stay but similar 30-day complication rates. At a median follow-up of 9 months, only 1 recurrence was documented. Conclusions RI is a rare and late complication of RYGB and typically occurs after significant weight loss. In the presence of ischemia or nonreducible RI, resection and revision of the jejunojejunostomy is recommended. In less acute patients, laparoscopic management with reduction and/or enteropexy offers a reduced hospital length of stay while maintaining equivalent morbidity and low recurrence compared with resection.

Background We hypothesized that laparoscopic adjustable gastric band (LAGB) placement might result in the development of a hiatal hernia (HH) over time. The objective of our study was to determine whether HHs develop after LAGB in the setting of a university hospital. Methods We retrospectively reviewed all outcomes for consecutive LAGB patients in our institutional, longitudinal prospective bariatric surgical database to identify those patients without evidence of a HH at LAGB placement, who subsequently underwent delayed HH repair. Results From 2005 to 2009, 695 gastric bands were implanted. Twelve patients (1.72%) were identified who had no radiographic or intraoperative evidence of a HH at LAGB placement and who subsequently underwent HH repair at re-exploration. Patients presented 18 ± 10 months after band placement. Of these patients, 75% presented with gastroesophageal reflux disease or food intolerance (50% with gastroesophageal reflux disease alone). Also, 2 presented with acute pain due to band slippage and 1 with chronic pain and vomiting. In 50% of the patients, revision procedures detected the HH at operation despite negative preoperative studies. Conclusion In our series, a significant HH developed in 1.7% of LAGB patients who had no clinically identifiable HH at LAGB placement. Persistent dysphagia after band deflation requires careful inspection of the hiatus during surgical revision, even in the absence of radiologic depiction of HH, and might represent an underlying etiology of LAGB dysfunction. This complication, along with esophageal dilation and annular pouch dilation, might represent a constellation of conditions with a common etiology. From the results of our small series, we raise the question of the existence of chronic backpressure created by LAGB restriction and accounting for these complications.

Hypoglycemia is increasingly recognized as a complication of bariatric surgery. Typically hypoglycemia does not appear immediately postoperatively, but rather more than 1 year later, and usually occurs 1–3 hours after meals. While rare, insulinoma has been reported after bariatric surgery. Clinical factors which should raise suspicion for insulinoma and the need for comprehensive clinical and biochemical evaluation include hypoglycemia occurring in the fasting state, predating bariatric surgery and/or worsening immediately postoperatively, and lack of response to conservative therapy. Localization and successful resection of insulinoma can be achieved using novel endoscopic ultrasound and surgical approaches. In summary, hypoglycemia presenting shortly after gastric bypass or with a dominant fasting pattern should be fully evaluated to exclude insulinoma. Additionally, evaluation prior to gastric bypass should include screening for history of hypoglycemia symptoms.

Laparoscopic adjustable gastric band (LAGB) has gone through major design modifications to improve clinical endpoints and reduce complications. Little is known, however, about the effects of LAGB size on clinical outcomes, or whether outcomes differ based on gender. We set out to examine the impact of band size on surgical weight loss, reoperations, comorbidity resolution, and compare outcomes within gender.We reviewed our prospectively collected longitudinal bariatric database between 2008 and 2010, and compared patients with BMI 35-50 kg/m(2) who had undergone LAGB with the LAP-BAND® APS to those who had the larger APL. Those patients with initial BMI 50 kg/m(2) were excluded to reduce any possible selection bias which favors larger band use in such subjects.Three hundred ninety-four patients met our inclusion criteria; 230 (58 %) in the APS group and 164 (42 %) in the APL group. Female patients in APS group experienced significantly higher percentage excess body weight loss at 6 months, 1 year, and 2 years in comparison to female patients in APL group (p 0.001 for all time points). In contrast, a reverse pattern was observed for male patients. No significant differences were observed between the groups regarding frequency of band adjustments, complications, or comorbidity resolution.Male patients might benefit from APL bands, in contrast to female patients who appear to experience superior weight loss with the smaller APS bands. This study provides the first set of evidence to facilitate surgical decision making for band size selection and highlights differences between genders.

The aim of this article is to describe the context in which this issue of Gastrointestinal Endoscopy Clinics of North America is established. The authors review the current worldwide dimensions and trends of the obesity epidemic; associated mortality and comorbid diseases including diabetes, cancer, cardiovascular disease and obstructive sleep apnea; the financial impact of obesity; and current national and international guidelines for referral and qualification for surgical treatment of obesity.

In 1991, a National Institutes of Heath expert consensus panel recommended bariatric surgery to treat obesity for informed and motivated patients with BMI >40 kg/m2, or between 35 and 40 kg/m2 with high-risk comorbid conditions including diabetes, in whom operative risks are acceptable (1). In December 2010, these guidelines were reviewed by the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee of the Food and Drug Administration, with recommendation to lower the criteria for use of the laparoscopic adjustable gastric band to BMI >30 kg/m2 for patients with comorbidity. Surgical treatments of obesity induce impressive absolute weight loss of 30–40 kg (∼60% excess weight, or a 10–15 kg/m2 reduction in BMI) (2), which may be sustained over 10–15 years (3). Increasing medical and public awareness of sustained weight loss, increased ease of recovery, and lowered complications with newer laparoscopic surgical procedures and the ongoing increased incidence of obesity have contributed to a 15-fold increase in bariatric surgical procedures in the past decade, with estimates of >200,000 procedures having been performed in the United States in 2007 (4). Recent observational studies demonstrate that bariatric surgical procedures reduce the incidence of type 2 diabetes and lead to substantial improvement or “resolution” for many patients with preexisting disease. Type 2 diabetes has “resolved” (defined in the surgical literature as maintenance of normal blood glucose after discontinuation of all diabetes-related medications, in most studies with HbA1c

Background Common endoscopic findings in patients who have undergone Roux-en-Y gastric bypass (RYGB) with chronic abdominal pain have included marginal ulceration, gastrogastric fistula, and jejunal erosion. However, suture or staples eroding into the gastric pouch can also contribute to abdominal pain. Redundant suture is typically regarded as a normal part of the postoperative anatomy. The objectives of the present study were to assess the effects of endoscopic foreign body removal of partially exposed sutures and staples in post-RYGB patients with chronic abdominal pain at a university hospital in the United States. Methods We performed a retrospective study of consecutive patients from January 2006 to July 2007. Post-RYGB patients with chronic abdominal pain underwent endoscopic foreign body removal of exposed sutures/staples. Pain scores were obtained before the procedure, immediately after the procedure, and at the telephone follow-up (median 7.2 months). Results Of 21 patients, 15 (71%) reported immediate symptomatic improvement. Specific endoscopic accessories were found to be more useful than others in managing the various foreign materials. Of the 21 patients, 15 (71%) were available for telephone follow-up. Of these 15 patients, 13 (87%) reported continued symptomatic improvement, with 9 (60%) reporting complete pain resolution and 4 (27%) reporting partial improvement. Eroded foreign material was seen in association with marginal ulcers in 3 patients (14%), gastritis in 7 patients (33%), and an inflammatory polyp in 1 patient (5%). Conclusions Eroded suture and staples can cause chronic abdominal pain in post-RYGB patients. In symptomatic patients, visible suture or staples should be considered a potential etiology of chronic pain, instead of normal postoperative findings. Endoscopic foreign body removal might be of therapeutic benefit in these patients.

With the sharp rise in the number of bariatric surgical procedures over the past 15 y, the number and array of complications have also risen. Many of these complications are now either diagnosed or managed endoscopically. However, the rising diversity of surgical options requires endoscopists to have a good working knowledge of normal postoperative anatomy for each procedure. This article reviews basic obesity epidemiology and describes postsurgical anatomy of the upper gastrointestinal tract, separating the procedures into those with normal small bowel anatomy (restrictive procedures) and procedures resulting in small bowel modifications (procedures with a “malabsorptive” component).

Background Some patients are thought to regain weight after gastric bypass surgery because of dilation of the gastrojejunal anastomosis (GJA) and/or gastric pouch. Objective To assess the technical success and safety of an endoscopic procedure, Revision Obesity Surgery Endoscopic (ROSE), using an endoscopic operating system for the placement of tissue anchors to reduce the diameter of the GJA and size of the gastric pouch. Design Prospective case series. Setting Brigham and Women's Hospital, Boston, Massachusetts. Patients and Interventions A total of 20 patients who had regained a mean of 13 kg after gastric bypass, with a dilated pouch and GJA on screening endoscopy, underwent the ROSE procedure. Main Outcome Measurements Technical success, reduction in size of the GJA and gastric pouch, and early complications. Early weight loss was also assessed. Results Technical success was achieved in 17 of 20 (85%) patients with an average reduction in stoma diameter of 16 mm (65% reduction) and an average reduction in pouch length of 2.5 cm (36% reduction). The mean weight loss in successful cases was 8.8 kg at 3 months. There were no major complications. Limitations Single-center case series with a relatively small number of patients and short duration of follow-up, which was inadequate for assessing durable long-term weight loss. Conclusion The ROSE procedure is technically feasible and appears safe. Data from this series suggest that the ROSE procedure is effective in reducing not only the size of the GJA but also the gastric pouch and may provide an endoscopic alternative for weight regain in gastric bypass patients.

To update evidence-based best practice guidelines for coding and reimbursement and establish policy and access standards for weight loss surgery (WLS). Systematic search of English-language literature on WLS and health-care policy, access, insurance reimbursement, coding, private payers, public policy, and mandated benefits published between April 2004 and May 2007 in MEDLINE, EMBASE, and the Cochrane Library. Use of key words to narrow the search for a selective review of abstracts, retrieval of full articles, and grading of evidence according to systems used in established evidence-based models. We identified 51 publications in our literature search; the 20 most relevant were examined in detail. These included reviews, cost-benefit analyses, and trend and cost studies from administrative databases. Literature on policy issues surrounding WLS are very sparse and largely focused on economic analyses. Reports on policy initiatives in the public and private arenas are primarily limited to narrative reviews of nonsurgical efforts to fight obesity. A substantial body of work shows that WLS improves or reverses most obesity-related comorbidities. Mounting evidence also indicates that WLS confers a significant survival advantage for those who undergo it. WLS is a viable and cost-effective treatment for an increasingly common disease, and policy decisions are more frequently being linked to incentives for national health-care goals. However, access to WLS often varies by payer and region. Currently, there are no uniform criteria for determining patient appropriateness for surgery.

APPROXIMATELY TWO-THIRDS of the US population is overweight or obese. The effects of the comorbidities that accompany obesity often are severe and can be life threatening over time. Currently, the most effective and sustainable method of substantial weight loss is bariatric surgery. Bariatric surgery also has been successful in reversing comorbidities. THE BENEFITS, RISKS, AND COMPLICATIONS of common weight-loss surgical procedures (eg, Roux-en-Y gastric bypass, laparoscopic adjustable gastric banding, vertical-banded gastroplasty, biliopancreatic diversion and duodenal switch) are discussed. THE HEALTH CARE FIELD OF BARIATRICS is growing rapidly. More information is needed to support and guide changes in current standards of practice to better meet the needs of this patient population.

Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) functions as a negative regulator of endogenous and vaccine-induced antitumor immunity. The administration of fully human anti-CTLA-4 blocking monoclonal antibodies to advanced-cancer patients increases immune-mediated tumor destruction in some subjects. Nonetheless, patients that respond also frequently manifest serious inflammatory pathologies, raising the possibility that the therapeutic and toxic effects of CTLA-4 blockade might be linked. Here we show that periodic infusions of anti-CTLA-4 antibodies after vaccination with irradiated, autologous tumor cells engineered to secrete GM-CSF (GVAX) generate clinically meaningful antitumor immunity without grade 3 or 4 toxicity in a majority of metastatic melanoma patients. The application of this sequential immunotherapy to advanced ovarian carcinoma patients also revealed that tumor destruction and severe inflammatory pathology could be dissociated, although further refinements are required to increase clinical responses and to minimize toxicity in this population. The extent of therapy-induced tumor necrosis was linearly related to the natural logarithm of the ratio of intratumoral CD8 + effector T cells to FoxP3 + regulatory T cells (Tregs) in posttreatment biopsies. Together, these findings help clarify the immunologic and clinical effects of CTLA-4 antibody blockade in previously vaccinated patients and raise the possibility that selective targeting of antitumor Tregs may constitute a complementary strategy for combination therapy.

Obesity is a rapidly increasing, worldwide epidemic. Despite recent scientific advances, no currently recommended dietary program or medication results in long-term weight loss of more than 10% of body weight for the vast majority of people who attempt these interventions. Hence, surgical intervention is recommended for patients with a BMI > or =40 kg/m2. Although surgery is an effective, sustainable treatment of obesity, it can be associated with potentially significant perioperative risks and long-term complications. Current research is focused on developing a medical therapy, which produces more effective and sustainable weight loss, yet avoids the risks inherent in major surgery. With a reduced risk profile, such therapy could also be appropriately offered to those who are less obese and, in theory, help those who have BMIs as low as 27 kg/m2. Toward that end, numerous scientists are working to both unravel the pathophysiology of obesity and to determine why surgical intervention is so effective. This review briefly examines the current status of obesity pathophysiology and management, the reasons for failure of conventional medical treatments, and the success of surgical intervention. Finally, future areas of research are discussed.

Background The objectives of this study were to evaluate outcomes and predictors of morbidity in patients undergoing Roux-en-Y gastric bypass (RYGB) during the Patient Safety in Surgery (PSS) Study. Study Design National Surgical Quality Improvement Program data on PSS patients undergoing RYGB were analyzed for unadjusted and adjusted outcomes. Gender groups acted differently and were analyzed separately. Multivariable regression modeling was used to analyze hospital type as a predictor of risk. Stepwise logistic regression was performed to determine patient factors predictive of postoperative morbidity. Results A total of 2,438 patients (2,064 private sector [PS], 374 Veterans Affairs [VA]) were identified for analysis. Adjusted odds ratio for postoperative morbidity for VA versus PS female patients was 1.14 (95% CI, 0.63−2.05), and for male patients 2.29 (95% CI, 1.28−4.10). Stepwise logistic regression showed that independent risk factors predictive of morbidity were open procedure, higher American Society of Anesthesiologists class, higher body mass index, diabetes, alcohol consumption, leukocytosis, SGOT > 40 U/L, smoking history, and older age. Importantly, male gender was not significant (p = 0.13) in the regression analysis. Subsequent and unrelated to this study, the VA has restructured its bariatric surgical program, including regionalization of centers, with a substantial lowering of associated mortality and morbidity. Conclusions The VA male subset showed higher risk-adjusted postoperative morbidity compared with the PS male subset. The VA and PS female subsets had equivalent risk-adjusted postoperative morbidity. A systematic approach to quality-improvement processes resulted in improved bariatric surgical outcomes in the VA. Male gender might not be an independent risk factor in RYGB patients.

Recommendations for surgical, compared with lifestyle and pharmacologically based, approaches for type 2 diabetes (T2D) management remain controversial.The objective was to compare laparoscopic adjustable gastric band (LAGB) to an intensive medical diabetes and weight management (IMWM) program for T2D.This was designed as a prospective, randomized clinical trial.The setting was two Harvard Medical School-affiliated academic institutions. INTERVENTIONS AND PARTICIPANTS: A 12-month randomized trial comparing LAGB (n = 23) vs IMWM (n = 22) in persons aged 21-65 years with body mass index of 30-45 kg/m(2), T2D diagnosed more than 1 year earlier, and glycated hemoglobin (HbA(1c)) ≥ 6.5% on antihyperglycemic medication(s).The proportion meeting the prespecified primary glycemic endpoint, defined as HbA(1c)6.5% and fasting glucose7.0 mmol/L at 12 months, on or off medication.After randomization, five participants did not undergo the surgical intervention. Of the 40 initiating intervention (22 males/18 females; age, 51 ± 10 y; body mass index, 36.5 ± 3.7 kg/m(2); diabetes duration, 9 ± 5 y; HbA(1c), 8.2 ± 1.2%; 40% on insulin), the proportion meeting the primary glycemic endpoint was achieved in 33% of the LAGB patients and 23% of the IMWM patients (P = .457). HbA(1c) reduction was similar between groups at both 3 and 12 months (-1.2 ± 0.3 vs -1.0 ± 0.3%; P = .496). Weight loss was similar at 3 months but greater 12 months after LAGB (-13.5 ± 1.7 vs -8.5 ± 1.6 kg; P = .027). Systolic blood pressure reduction was greater after IMWM than LAGB, whereas changes in diastolic blood pressure, lipids, fitness, and cardiovascular risk scores were similar between groups. Patient-reported health status, assessed using the Short Form-36, Impact of Weight on Quality of Life, and Problem Areas in Diabetes, all improved similarly between groups.LAGB and a multidisciplinary IMWM program have similar 1-year benefits on diabetes control, cardiometabolic risk, and patient satisfaction, which should be considered in the context of other factors, such as personal preference, when selecting treatment options with obese T2D patients. Longer duration studies are important to understand emergent differences.

Background: Idiopathic intracranial hypertension is a condition associated with morbid obesity. Although bariatric surgery offers an effective treatment, some bariatric surgical candidates will present with indwelling ventriculoperitoneal (VP) shunts. The maintenance of shunt sterility is paramount. Objective: To review our experience with a regimen of VP shunt externalization, in patients undergoing primary bariatric procedures. Setting: Academic University Hospital Methods: Records of all patients who underwent bariatric procedures between 4/1/2004 and 11/1/2007 were reviewed. Our protocol was to externalize all shunts at the beginning, for patients undergoing Roux-en-Y gastric bypasses (RYGB), and to leave all shunts externalized for one week; shunts were re-internalized at a subsequent procedure if no signs of infection were present. Laparoscopic adjustable gastric banding (LAGB) patients would have the shunt evaluated simultaneously and left in place if functional. Results: Of the 1759 patients who underwent bariatric procedures from 2004 to 2007, 6 had indwelling VP shunt. Four patients underwent laparoscopic RYGB, 1an open RYGB, and 1 patient underwent LAGB with the same VP shunt management protocol. All patients had their shunts reinternalized without sequelae, with the exception of one patient who was no longer shunt dependent. One patient did have migration outside of the abdominal wall by the shunt; to prevent migration, the shunt was fixed to a section of prolene mesh. No patients developed evidence of contamination. Conclusions: The technique of VP shunt externalization may be a safe and effective technique of managing VP shunt during bariatric surgical procedures. Categories: General Surgery

Importance Emerging data support bariatric surgery as a therapeutic strategy for management of type 2 diabetes mellitus. Objective To test the feasibility of methods to conduct a larger multisite trial to determine the long-term effect of Roux-en-Y gastric bypass (RYGB) surgery compared with an intensive diabetes medical and weight management (Weight Achievement and Intensive Treatment [Why WAIT]) program for type 2 diabetes. Design, Setting, and Participants A 1-year pragmatic randomized clinical trial was conducted in an academic medical institution. Participants included persons aged 21 to 65 years with type 2 diabetes diagnosed more than 1 year before the study; their body mass index was 30 to 42 (calculated as weight in kilograms divided by height in meters squared) and hemoglobin A 1c (HbA 1c ) was greater than or equal to 6.5%. All participants were receiving antihyperglycemic medications. Interventions RYGB (n = 19) or Why WAIT (n = 19) including 12 weekly multidisciplinary group lifestyle, medical, and educational sessions with monthly follow-up thereafter. Main Outcomes and Measures Proportion of patients with fasting plasma glucose levels less than 126 mg/dL and HbA 1c less than 6.5%, measures of cardiometabolic health, and patient-reported outcomes. Results At 1 year, the proportion of patients achieving HbA 1c below 6.5% and fasting glucose below 126 mg/dL was higher following RYGB than Why WAIT (58% vs 16%, respectively; P = .03). Other outcomes, including HbA 1c , weight, waist circumference, fat mass, lean mass, blood pressure, and triglyceride levels, decreased and high-density lipoprotein cholesterol increased more after RYGB compared with Why WAIT. Improvement in cardiovascular risk scores was greater in the surgical group. At baseline the participants exhibited moderately low self-reported quality-of-life scores reflected by Short Form-36 total, physical health, and mental health, as well as high Impact of Weight on Quality of Life–Lite and Problem Areas in Diabetes health status scores. At 1 year, improvements in Short Form-36 physical and mental health scores and Problem Areas in Diabetes scores did not differ significantly between groups. The Impact of Weight on Quality of Life–Lite score improved more with RYGB and correlated with greater weight loss compared with Why WAIT. Conclusions and Relevance In obese patients with type 2 diabetes, RYGB produces greater weight loss and sustained improvements in HbA 1c and cardiometabolic risk factors compared with medical management, with emergent differences over 1 year. Both treatments improve general quality-of-life measures, but RYGB provides greater improvement in the effect of weight on quality of life. These differences may help inform therapeutic decisions for diabetes and weight loss strategies in obese patients with type 2 diabetes until larger randomized trials are performed. Trial Registration clinicaltrials.gov Identifier:NCT01073020

During Roux-en-Y gastric bypasses (RYGB), some surgeons elect to perform a vagotomy to reduce symptoms of gastro-oesophageal reflux (GER). Routine vagotomy during RYGB may independently affect weight loss and metabolic outcomes following bariatric surgery. We aimed to determine whether vagotomy augments percent excess weight loss in obese patients after RYGB.We examined the effect of vagotomy in 1278 patients undergoing RYGB at our institution from 2003 to 2009. Weight and percent excess weight loss (%EWL) were modelled at three months and annually up to five years using a longitudinal linear mixed model controlling for differences in age, gender, initial body mass index (BMI), ideal body weight, and presence of vagotomy.Vagotomy was performed on 40.3% of our cohort. Vagotomy patients had significantly lower initial BMI (46.4±6.2 vs. 48.3±7.7kg/m(2), p0.001), but there were no other significant differences at baseline. The strongest predictor of %EWL over time was initial BMI, with lower BMI patients exhibiting greater %EWL (p0.001). Age and gender effects were also significant, with younger patients (p0.04) and males (p0.002) attaining greater %EWL. Vagotomy had no effect on %EWL in either simple or multiple regression models.Our series suggest that vagotomy does not augment %EWL when performed with RYGB.

Dynamic cardiomyoplasty (DCM) is an emerging surgical procedure for heart failure in which the patient's latissimus dorsi (LD) muscle is wrapped around the heart and stimulated to contract in synchrony with the heartbeat as a cardiac assist measure. A 6 week training protocol of progressive electrical stimulation renders the normally fatigueable skeletal muscle fatigue-resistant and suitable for chronic stimulation. To date, over 500 procedures have been performed in worldwide clinical trials. Investigators typically report symptomatic improvement and modest hemodynamic improvement in patients. Controversy exists regarding the exact mechanism of DCM. To test the hypothesis that DCM augments cardiac stroke volume through improvement in systolic function, we formulated an engineering model of dynamic cardiomyoplasty to predict stroke volume. The heart and the LD were modeled as nested (series) elastance chambers, and the vasculature was represented by a two-element Windkessel model. Using five healthy goats, we verified model predictions of stroke volume for both stimulator ON beats (y = 1.00x-0.08, r = 0.87, p0.0001) and OFF beats (y = 1.01x+1.06, r = 0.91, p0.0001), where x and y are the measured and predicted stroke volumes, respectively. The model confirms that using untrained latissimus dorsi applied to the normal myocardium produces only moderate increases in stroke volume and suggests that future research should focus on increasing LD strength after training.

Gastroesophageal reflux disease (GERD) affects many morbidly obese patients. The Roux-en-y gastric bypass operation often achieves the simultaneous aims of weight reduction as well as reflux correction. However, some patients continue to suffer from severe gastroesophageal symptoms after successful postoperative weight reduction. There are no reports describing surgical treatments for these patients. Here we report our management of intractable postoperative reflux with a Belsey Mark IV fundoplication performed one year after a successful Roux-en-y gastric bypass operation. The patient tolerated the operation without problems and experienced successful resolution of her reflux symptoms.

Obesity is commonplace, and surgical treatment usually includes Roux-en-Y gastric bypasses (RYGBs). RYGBs have the most documented side effects including vitamin deficiencies, rebound weight gain, and symptomatic hypoglycemia; fewer series exist describing hypoglycemia following other bariatric operations. We reviewed all patients undergoing laparoscopic adjustable gastric banding (LAGB) at our institution between 2008 and 2012. Three patients were identified to have symptomatic hypoglycemia following LAGB. Mean time from surgery was 33 months (range 14–45 months), and mean weight loss was 32.7 kg (range 15.9–43.1 kg). None of the patients had preexisting diabetes. Therefore, symptomatic hypoglycemia should be investigated irrespective of bariatric operation.

Background and study aims: A dilated gastrojejunal anastomosis (GJA) is thought to be associated with weight regain in patients with Roux-en-Y gastric bypass (RYGB). Due to a high rate of perioperative morbidity, surgical revision is not generally performed. The aim of this study was to assess the technical feasibility, safety, and early outcomes of a procedure using a commercially available endoscopic suturing device to reduce the diameter of the GJA. Patients and methods: This was a retrospective analysis of 25 consecutive patients who underwent transoral outlet reduction (TORe) for dilated GJA and weight regain. An endoscopic suturing device was used to place sutures at the margin of the GJA in order to reduce its aperture. On chart review, clinical data were available at 3, 6, and 12 months. Results: Patients had regained a mean of 24 kg from their weight loss nadir and had a mean body mass index of 43 kg/m 2 at the time of endoscopic revision. Average anastomosis diameter was 26.4 mm. Technical success was achieved in all patients (100 %) with a mean reduction in anastomosis diameter to 6 mm (range 3 – 10 mm), representing a 77.3 % reduction. The mean weight loss in successful cases was 11.5 kg, 11.7 kg, and 10.8 kg at 3, 6, and 12 months, respectively. There were no major complications. Conclusion: This case series demonstrated the technical feasibility, safety, and efficacy of performing gastrojejunostomy reduction using a commercially available endoscopic suturing device. This technique may represent an effective and minimally invasive option for the management of weight regain in patients with RYGB.

A case report of the early results of laparoscopic bariatric surgery in six completely nonambulatory patients Sigrid Bairdain, M.D., M.P.H., Richard S. Flint, M.D., Chueh Lien, B.S., Mark Cleary, B.S., Bradley C. Linden, M.D., David B. Lautz, M.D., F.A.C.S.* Department of Surgery, Boston Children’s Hospital, Harvard Medical School, Boston, Massachusetts Department of Surgery, Brigham & Women’s Hospital, Harvard Medical School, Boston, Massachusetts Department of Surgery, Emerson-Mass General Hospital, Harvard Medical School, Concord, Massachusetts Received March 7, 2013; accepted June 3, 2013

Bariatric surgery is currently the most effective therapy available for the treatment of morbid obesity. The overall impact of these therapies on the quality and length of life is remarkable. This chapter will review current bariatric surgical procedures including vertical banded gastroplasty, laparoscopic adjustable gastric banding, Roux-en-Y gastric bypass, biliopancreatic diversion with or without duodenal switch, and laparoscopic sleeve gastrectomy. The weight loss and comorbidity outcomes of each procedure will be compared and complications reviewed. The current criteria for patient selection and preoperative evaluation are also reviewed including preoperative eating habits, psychological and physical evaluation.

Background Weight regain after Roux-en-Y gastric bypass (RYGB) is common. Endoscopic sclerotherapy is increasingly used to treat this weight regain. Objectives To report safety, outcomes, durability, and predictors of response to sclerotherapy in a large prospective cohort. Design Retrospective analysis of a prospective cohort study of patients with weight regain after RYGB. Patients A total of 231 consecutive patients undergoing 575 sclerotherapy procedures between September 2008 and March 2011. Interventions Single or multiple sclerotherapy procedures to inject sodium morrhuate into the rim of the gastrojejunal anastomosis. Main Outcome Measurements We report weight loss, complications, and predictors of response. We also used Kaplan-Meier survival analysis and log-rank test to compare time to continuation of weight regain after sclerotherapy in patients undergoing a single versus multiple sclerotherapy procedures. Results At 6 and 12 months from the last sclerotherapy procedure, weight regain stabilized in 92% and 78% of the cohort, respectively. Those who underwent 2 or 3 sclerotherapy sessions had significantly higher rates of weight regain stabilization than those who underwent a single session (90% vs 60% at 12 months; P = .003). The average weight loss at 6 months from the last sclerotherapy session for the entire cohort was 10 lb (standard deviation 16), representing 18% of the weight regained after RYGB. A subset of 73 patients (32% of the cohort) had greater weight loss at 6 months (26 lb, standard deviation 12), representing 61% of the weight regained. Predictors of a favorable outcome included greater weight regain and the number of sclerotherapy procedures. Bleeding was reported in 2.4% of procedures and transient diastolic blood pressure increases in 15%, without adverse health outcomes. No GI perforations were reported. Conclusions Endoscopic sclerotherapy appears to be a safe and effective tool for the management of weight regain after RYGB.

The number of people who are obese or morbidly obese is increasing in the United States. Currently, the most effective means of losing a substantial amount of weight and maintaining the weight loss is bariatric surgery, and health care providers, especially those in surgical services, must be able to safely care for patients undergoing these surgeries. Financial implications of starting a bariatric surgery program and the ongoing costs must be fully understood and supported by both administrators and employees. Special equipment and supplies are needed to handle the higher weight of bariatric patients, and careful planning is required for adequate medical and nursing expertise, staffing, equipment, supplies, facility resources, and patient support services.

Background The advent of metabolic surgery and the increasing focus on the substantial resolution rate of type 2 diabetes after laparoscopic Roux-en-Y gastric bypass (LRYGB) call for additional fundamental investigations as to the mechanisms behind this effect. These investigations require an adequate animal model. Our objective was to develop a reproducible survival model of LRYGB performed in a large animal at a tertiary university hospital. Methods LRYGB was performed on 11 Yorkshire pigs that where then followed for 6 weeks. The operative time, morbidity, and mortality were recorded for each case. Necropsy was performed, and the anastomoses were harvested and inspected for leaks. Results The surgical technique and difficulties are carefully described. Of the 11 pigs, 10 survived to the end of the study period. The 1 death was from intraoperative cardiac dysrhythmia. The postoperative complications consisted of a postoperative febrile episode in 2 pigs. The mean initial weight was 31.5 ± 3.4 kg. The mean operative time was 214 ± 71 minutes. No anastomotic leaks were identified at necropsy or on histologic examination of anastomoses. The mean weight gain at the end of the study period was .8 ± 1.4 kg compared with an expected 17.5 kg weight gain. Conclusion We have described an effective survival porcine model of LRYGB that can be consistently reproduced. This will enable additional investigation into the complex physiologic mechanisms that control hunger, weight loss, and the development, as well as resolution, of type 2 diabetes, potentially leading to the development of novel, targeted bariatric procedures and diabetic treatments.

Background With the increasing popularity of laparoscopic adjustable banding (LAGB), reoperations to treat band complications have become increasingly more common. Few studies, however, have documented the outcomes of such revisional procedures. The purpose of the present study was to compare the different reoperative approaches after LAGB placement. The present study was conducted at a tertiary referral academic medical center in the United States. Methods We reviewed our bariatric database to identify patients who had undergone LAGB from 2004 to 2007 and had undergone either revision of their original band or conversion to Roux-en-Y gastric bypass. Results Of the 66 patients who met our inclusion criteria, 47 (71.2%) had undergone revision and 19 (28.8%) conversion. The patient demographics were similar between the 2 groups. The interval to revision or conversion was 22 and 28 months, respectively. Band slippage was the most common surgical indication in the revision group, and inadequate weight loss was the most common in the conversion group. Although patients in the revision group had experienced good weight loss before their reoperation, the conversion group had not. However, the conversion group experienced good weight loss after their reoperation, with an average excess body weight loss of 48%. Conclusion Patients who have experienced successful weight loss with LAGB and experience band complications will have satisfactory outcomes with band revision, maintaining their excess body weight loss. These data suggest that patients with inadequate weight loss after LAGB can do well after conversion to Roux-en-Y gastric bypass.

Background Gastrogastric fistulas (GGFs) are a well-known complication of Roux-en-Y gastric bypass. Surgical repair of such fistulas is technically difficult, with significant associated morbidity. The aim of the present study was to evaluate the efficacy of endoscopic GGF closure at a university hospital in the United States. Methods Patients with Roux-en-Y gastric bypass and confirmed GGFs on esophagogastroduodenoscopy or barium study. Endoscopic repair was performed with the EndoCinch suturing system (group 1) or clips (group 2). All patients were followed up in the outpatient clinic or interviewed by telephone at 1, 6, and 18 months after the procedure, then as indicated by symptoms. Results A total of 95 patients were included in the present series (group 1, n=71, 75%; group 2, n=24, 25%). The mean GGF size was significantly larger in group 1 than in group 2 (14.5 ± 8.7 versus 7.7 ± 6, P = .01). An average of 2.2 sutures or 3 clips (range 2–7) was used. Complete initial GGF closure was achieved in 90 patients (95%), with reopening in 59 (65%) an average of 177 ± 202 days. The average follow-up was 395 ± 49 days, with 22 patients lost to follow-up. Two significant complications were reported (bleeding and an esophageal tear). None of the GGFs with an initial size >20 mm remained closed during the follow-up period compared with 10 (32%) of the 31 fistulas ≤10 mm in diameter remained closed. Conclusion Peroral endoscopic repair of postbariatric GGFs is technically feasible and safe but with limited durability. The fistula size predicted for long-term outcomes, with the best results seen in fistulas ≤10 mm in diameter.

The objective of this study is to update evidence-based best practice guidelines for specialized facilities and resources for weight loss surgery (WLS). We performed systematic search of English-language literature on WLS and facilities, equipment, and resources published between April 2004 and May 2007 in PubMed, MEDLINE, and the Cochrane Library. Keywords were used to narrow the search for a selective review of abstracts, retrieval of full articles, and grading of evidence according to systems used in established evidence-based models. Evidence-based best practice recommendations from the most recent literature on specialized facilities and resources for WLS were developed. We identified 1,647 papers in our literature search; the 46 most relevant were reviewed in detail. Regular updates of evidence-based recommendations for best practices in facilities and resources for WLS are required to address technology advances and growing recognition of the need for adequate equipment and specially built nursing units. Key factors in patient safety include availability of trained personnel and specialized equipment for the care of extremely obese WLS patients.

To update evidence-based best practice guidelines for surgical care in weight loss surgery (WLS). Systematic search of English-language literature on WLS in MEDLINE, EMBASE, and the Cochrane Library between April 2004 and May 2007. Use of key words to narrow the search for a selective review of abstracts, retrieval of full articles, and grading of evidence according to systems used in established evidence-based models. Evidence-based best practice recommendations from the most recent literature on surgical methods and technologies, risks and benefits, outcomes, and surgeon qualifications and credentialing. We identified >135 articles; the 65 most relevant were reviewed in detail. Regular updates of evidence-based recommendations for best practices in WLS are required to address rapid changes in surgical techniques and patient demographics. Key factors in patient safety include surgical risk factors, type of procedure, surgeon training, and facility certification.

Background Gastrointestinal complications after lung transplantation remain a common yet poorly defined problem. In this study we examine our experience with gastrointestinal complications after lung transplantation. Methods Between August 1990 and June 2005, we retrospectively analyzed 208 patients who had undergone lung transplantation (single, 65% [137 of 212]; double, 34% [72 of 212]; heart–lung, 0.5% [2 of 212]; living related, 0.5% [1 of 212]). Four patients were retransplanted. Gastrointestinal complications were defined as any post-transplant diagnosis related to the gastrointestinal tract. Results Ninety of 208 (43%) transplant patients developed 113 gastrointestinal complications during follow-up (median 3.5 years [62 days to 10.0 years]). Biliary etiology was the most common (12% [25 of 208]), requiring cholecystectomy in 13 patients. Diarrheal syndromes occurred in 21 patients (10%) with 2 patients requiring laparotomies. Small bowel obstruction and/or gastroparesis were present in 17 (5%) and 12 (6%) patients, respectively. Fourteen patients required surgical lysis of adhesions for small bowel obstruction and 7 patients underwent gastric drainage procedures. Three patients had peptic ulcer disease with 2 patients requiring laparotomy for perforated duodenal ulcer. Ten patients developed gastrointestinal bleeding with 1 requiring a colectomy. Three patients presented with diverticulitis and 2 required colectomy. Three patients required laparotomy due to intraperitoneal leakage of gastric secretions after gastromy tube placement. Eleven (16%) deaths were directly related to gastrointestinal complications. Of those patients who required a laparotomy for indications other than cholelithiasis, 9 (35%) died within 8 weeks. Conclusions Gastrointestinal complications are common after lung transplantation and are associated with considerable morbidity and mortality. Vigilance is required for early recognition and prompt treatment.

Background Dumping syndrome is a well-described consequence of Roux-en-Y gastric bypass. Although the condition can benefit some patients with morbid obesity, a subset will develop intractable dumping syndrome characterized by symptomatic episodes with most meals. We describe the first series of patients successfully treated endoscopically for intractable dumping syndrome. Methods Endoscopic gastrojejunal anastomotic reduction was performed in patients with intractable dumping syndrome after Roux-en-Y gastric bypass using a combination of argon plasma coagulation, endoscopic suturing, and fibrin glue. The technical feasibility of endoscopic anastomotic reduction and the clinical improvement in dumping symptoms were assessed by clinical follow-up. Results Endoscopic anastomotic reduction was technically successful in 6 consecutive patients with a dilated gastrojejunal anastomosis and intractable dumping syndrome. One patient reported hematemesis 2 days after the procedure that was treated endoscopically. No other significant complications occurred. Complete and persistent resolution of the dumping symptoms was achieved in all patients, with a median follow-up of 636 days. Conclusion Endoscopic anastomotic reduction appears technically feasible and safe and might be a minimally invasive treatment option for patients who experience intractable dumping symptoms after Roux-en-Y gastric bypass. Additional studies are needed to determine the long-term efficacy of this procedure.

Background For some gastric bypass patients, dilation of the gastrojejunal anastomosis (GJA) and/or gastric pouch is believed to contribute to weight regain. The present study had 2 objectives: (1) to assess the technical feasibility and safety of a novel endoscopic procedure called "revision obesity surgery endoscopic" (ROSE) using a second-generation, prototype endoscopic operating system that creates tissue plications to reduce the diameter of the GJA and the size of the gastric pouch; and (2) to assess the early outcomes regarding weight loss at a university hospital in the United States. Methods This was a prospective study of 5 patients who had regained a mean of 14.7 kg after gastric bypass with a dilated pouch and GJA on screening endoscopy. The gastric pouch and the GJA were measured before and after the procedure. The patients were followed up for a minimum of 3 months after the procedure. Weight changes were recorded. Results Technical success was achieved in all 5 patients (100%). The mean weight loss in the successful cases was 7.8 kg at 3 months. No major complications developed. Conclusion The results of our study have shown that the ROSE procedure using this second-generation prototype endoscopic operating system is technically feasible and appears safe. Our preliminary results suggest that the ROSE procedure is effective in reducing the size of both the GJA and the gastric pouch and could therefore be an alternative therapy for weight regain in postgastric bypass patients.

Roux-en-Y gastric bypass (RYGB) is an effective treatment for severe obesity. However, many patients regain weight over time. The mechanisms for this are unclear, and several factors may contribute, including dilation of the gastrojejunal anastomosis. This study aimed to assess the feasibility of endoscopic gastrojejunal anastomotic tightening and to determine the effect of tightening on body weight. Eight patients with significant weight regain and dilated gastrojejunal anastomosis after RYGB were included in this pilot study. Sutures were placed endoscopically at the rim of the anastomosis. When tightened, the sutures formed tissue placations, reducing the size of the anastomotic aperture. The average preprocedure body mass index (BMI) was 40.5, and the patients had regained a mean of 24 kg from their post-RYGB nadir. The average pouch length was 5.7 cm, and the average anastomotic diameter was 25 mm. The average postreduction diameter was 10.0 mm (68% reduction). Six of the eight patients showed weight loss (mean, 10 kg) at 4 months. Repeat procedures were performed for three patients who had lost 4, 5, and 9 kg, respectively with the initial procedure. After the second anastomotic reduction, the final diameters were, respectively, 14, 5, and 5 mm. The first patient did not have further weight loss. The remaining two patients showed a total weight loss of 19 and 20 kg, respectively, at 5 months. All 11 reductions were accomplished without significant complication. The average postreduction BMI was 37.7, and the percentage of excess weight loss was 23.4%. Peroral endoscopic suturing to tighten dilated gastrojejunal anastomoses appears technically feasible and safe. This procedure is associated with variable but significant weight loss, and preliminary results suggest that it may offer a new treatment option for postbypass weight regain in selected patients.

Background Gastric leaks represent an important source of morbidity and mortality associated with Roux-en-Y gastric bypass. These leaks, once managed acutely, can become chronic and represent a difficult clinical challenge. Surgical options to address a chronic gastric leak are technically challenging and often unsuccessful. We present a novel peroral endoscopic treatment for patients with chronic gastric leaks after Roux-en-Y gastric bypass. Design Case series. Interventions Repair of chronic gastric leaks after Roux-en-Y gastric bypass by using a combination of argon plasma coagulation, hemoclips, fibrin glue, Polyflex stent placement, and distal gastrojejunal stenosis dilation. The goal was to achieve durable fistula closure and avoid surgery. Main Outcome Measurements Durable fistula closure as assessed by an upper-GI series and clinical evaluation. Results Gastric leak closure was achieved in all 3 patients, with complete resolution of symptoms. Polyflex stent migration into the Roux limb occurred in 1 patient, and this was retrieved endoscopically. There were no other significant complications. Conclusions Peroral endoscopic repair of gastric leaks is technically feasible. This procedure may offer a less invasive alternative to traditional surgical revision.

Objective: To establish evidence-based guidelines for best practices for surgical care in weight loss surgery (WLS). Research Methods and Procedures: We carried out a systematic search of English-language literature on WLS in MEDLINE and the Cochrane Library. Key words were used to narrow the field for a selective review of abstracts. Data extraction was performed, and evidence categories were assigned according to a grading system based on established evidence-based models. Results: We assessed types of WLS, recommended guidelines for appropriateness, developed strategies for medical error reduction, established criteria for credentialing of systems and practitioners, and specified research needed for the future. Discussion: Surgeon training, credentialing, and type of surgery performed were identified as key factors in patient safety. Other important issues in the delivery of best practice care included appropriate patient selection; use of a multidisciplinary treatment team; facility staffing, equipment, and administrative support; and early recognition and proper management of complications.