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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.

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

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.

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.

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

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 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 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.

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.

Weight regain after Roux-en-Y gastric bypass (RYGB) is associated with reductions in health status and quality of life. We evaluated whether gastrojejunal stoma diameter is a risk factor for weight regain after RYGB.We examined data collected over 4 years from consecutive patients referred to a tertiary care bariatric center for upper endoscopy after RYGB. We used linear regression analysis to determine the association between the gastrojejunal stoma diameter and weight regain. We applied a logistic regression model using clinical and endoscopic parameters to develop a prediction rule for weight gain after RYGB.Among 165 patients included in our study, 59% had significant weight regain (≥ 20% of maximum weight lost after the RYGB) and 41% did not. The mean percentage of maximal weight lost after RYGB that was regained in the entire cohort was 30% ± 22%. Gastrojejunal stoma diameter was associated significantly with weight regain after RYGB surgery in univariate analysis (β = .31, P.0001). This association remained significant after adjusting for several known or purported risk factors for weight regain (β = .19, P = .003). We developed a simple prediction rule for weight regain after RYGB using a 7-point scoring system that includes the gastrojejunal stoma diameter, race, and percentage of maximal body weight lost after RYGB; a cut-off score of 4 or more points had an area under receiver operating characteristic curve of 0.76 and a positive predictive value of 75%.Increased gastrojejunal stoma diameter is a risk factor for weight regain after RYGB and can be incorporated in a novel prediction rule.

Transmyocardial laser revascularization is a promising surgical technique used to treat nonreconstructable ischemic heart disease. Recent clinical data show that this technique improves the regional perfusion of ischemic myocardium and reduces angina. Presently, transmyocardial laser revascularization requires an open, lateral thoracotomy. We report here the use of thoracoscopic techniques to perform transmyocardial laser revascularization in a closed chest fashion.Five Yorkshire farm pigs underwent left chest thoracoscopic exploration and pericardiotomy. A specialized laser handpiece then was introduced into the chest and thoracoscopic transmyocardial laser revascularization was performed (one channel per square centimeter) using an 800-W CO2 laser.Video analysis and gross pathology revealed that the anatomic area accessible to thoracoscopic transmyocardial laser revascularization included the entire left ventricular free wall distributions of the left anterior descending, left circumflex, and posterior descending arteries, from base to apex. Standard hematoxylin and eosin staining confirmed the creation of complete and patent 1-mm-diameter transmural channels throughout these distributions.We have shown that transmyocardial laser revascularization can be performed effectively and safely by thoracoscopy, and that this less invasive technique may reduce morbidity and provide a more cost-effective alternative therapy for nonreconstructable ischemic heart disease.

Weight regain or insufficient loss after Roux-en-Y gastric bypass (RYGB) is common. This is partially attributable to dilatation of the gastrojejunostomy (GJ), which diminishes the restrictive capacity of RYGB. Endoluminal interventions for GJ reduction are being explored as alternatives to revision surgery. We performed a randomized, blinded, sham-controlled trial to evaluate weight loss after sutured transoral outlet reduction (TORe).Patients with weight regain or inadequate loss after RYGB and GJ diameter greater than 2 cm were assigned randomly to groups that underwent TORe (n = 50) or a sham procedure (controls, n = 27). Intraoperative performance, safety, weight loss, and clinical outcomes were assessed.Subjects who received TORe had a significantly greater mean percentage weight loss from baseline (3.5%; 95% confidence interval, 1.8%-5.3%) than controls (0.4%; 95% confidence interval, 2.3% weight gain to 3.0% weight loss) (P = .021), using a last observation carried forward intent-to-treat analysis. As-treated analysis also showed greater mean percentage weight loss in the TORe group than controls (3.9% and 0.2%, respectively; P = .014). Weight loss or stabilization was achieved in 96% subjects receiving TORe and 78% of controls (P = .019). The TORe group had reduced systolic and diastolic blood pressure (P.001) and a trend toward improved metabolic indices. In addition, 85% of the TORe group reported compliance with the healthy lifestyle eating program, compared with 53.8% of controls; 83% of TORe subjects said they would undergo the procedure again, and 78% said they would recommend the procedure to a friend. The groups had similar frequencies of adverse events.A multicenter randomized trial provides Level I evidence that TORe reduces weight regain after RYGB. These results were achieved using a superficial suction-based device; greater levels of weight loss could be achieved with newer, full-thickness suturing devices. TORe is one approach to avoid weight regain; a longitudinal multidisciplinary approach with dietary counseling and behavioral changes are required for long-term results. ClinicalTrials.gov identifier: NCT00394212.

Background: Roux-en-Y gastric bypass (RYGB) is an effective surgery for weight loss in obese patients. Current guidelines recommend advancement to regular diet in 1-2 months postRYGB. Failure to advance or dietary intolerancemay have clinical and nutritional implications. A prior study suggested that up to 30% of post-RYGB patients may develop dysphagia. RYGB may affect the Vagal innervation to the esophagus, and the resultant esophageal dysmotility may play a role in post-RYGB dietary complications. Understanding esophageal motor functions by high-resolution manometry (HRM) and their association with dietary outcome post-RYGB may allow more effective, targeted therapy for symptoms and dietary complications. Aim: To investigate the association between esophageal motor dysfunctions on HRM and intolerance to solid diet among post-RYGB patients. Methods: This was a retrospective cohort study of post-RYGB patients who underwent HRM at a tertiary care center in 6/2007-5/2012. Patients with underlying esophageal dysmotility pre-RYGB, HRM performed less than 2 months after RYGB, or need for parenteral or tube feeding were excluded. The primary outcome was diet at the time of HRM (liquid [LD] vs solid [SD]). Esophageal motor characteristics were extracted from HRM. Fisher-exact or chi-squared test for binary variables and student's t-test for continuous variables were used to assess for differences between LD and SD groups. Multivariate analysis was performed using forward stepwise logistic regression. Results: 63 patients met inclusion criteria (age 51±10.3 yrs, 91% F), and 21 subjects (33.3%) could only tolerate LD. Patients on LD were more likely to have at least one abnormal parameter on HRM than those on SD (61.9% vs 28.6%, p= 0.01). Univariate analyses showed that elevated basal lower esophageal sphincter (LES) pressure (9.52% vs 0%, p=0.04), incomplete LES relaxation (22% vs 0%, p= 0.04), increased esophageal body contraction amplitude (119±56 vs 93±41 mmHg, p=0.05), and dysphagia (52% vs 16%, p= 0.003) were significantly associated with LD. On multivariate analysis, incomplete LES relaxation remained an indepedent predictor for LD (OR 11.73, p=0.02). Conclusions: Post-RYGB patients unable to tolerate SD are more likely to have abnormal findings on HRM. Incomplete LES relaxation is independently associated with LD use, while other hypermotility patterns (hypertensive LES and increased esophageal body contraction) are also more prevalent. In addition to pouch or anastomotic abnormalities, esophageal motor dysfunction should be considered in assessing post-RYGB patients' failure to tolerate SD. HRM should play a role in evaluating post-RYGB dietary complications. Future studies should examine the potential causes of this dysfunction and explore the effect of therapies targeting LES relaxation on clinical and dietary outcome.

Background and aims: Roux-en-Y gastric bypass technique (RYGBP) by inducing bacterial stasis could promote small intestinal bacterial overgrowth (SIBO). In a previous study performed in 146 patients with morbid obesity (1) we found an increase in the prevalence of SIBO compared to healthy subjects 17.1% vs.2.5% (p=0.03). The aim of this study was to evaluate prospectively the prevalence of SIBO in a larger population of patients withmorbid obesity, before and after bariatric surgery and its potential effect on vitamin deficiencies after surgery. Patients and methods: from October 2001 to July 2009, a glucose hydrogen (H2) breath test (BT, positive if fasting breath H2 concentration > 20 ppm and or increase > 10 ppm over baseline within the first 2 hours) was proposed to all obese patients referred for bariatric surgery (BMI > 40 kg/m 2 or > 35 in association with comorbidities) before and after bariatric surgery to assess the presence of SIBO. Vitamin levels (B12, B1, PP) were measured while vitamin supplementation was systematically prescribed after RYGBP. Results(mean ± SE, median (IQR) : 378 patients (336 women (88.9%), 39.6± 11.7 yrs, BMI : 45.7±6.3 kg/m 2 ) were included : 357 patients had a preoperative BT that was positive in 55 cases (15.4%), negative in 290 cases (81,2%) and doubtful or uninterpretable in 12 cases (3.4%). Twenty patients had BT after gastric banding [time since surgery 36 months (26-47), weight loss 22.9±14.1 kg] that was negative in 18 cases (90%) and positive in 2 cases (10%) (p = NS compared with preoperative situation). Sixty-five patients had a BT after RYGBP [time since surgery 9.2 months (6.8-23), weight loss 34.4± 11.5 kg] that was negative in 39 cases (60%) and positive in 26 cases (40%) (p