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Background: The effect of laparoscopic sleeve gastrectomy (LSG) on gastroesophageal reflux disease (GERD) is controversial. Although concomitant hiatal hernia repair (HHR) at the time of LSG is common and advocated by many, there are few data on the outcomes of GERD symptoms in these patients. The aim of this study was to evaluate the effect of concomitant HHR on GERD symptoms in morbidly obese patients undergoing LSG., Methods: A single institution, multi-surgeon, prospectively maintained database was examined to identify patients who underwent LSG and concomitant HHR from December 2010 to October 2013. Patient characteristics, operative details, and postoperative outcomes were analyzed. Standardized patient questionnaires administered both pre- and postoperatively were utilized. Primary endpoints included subjective reflux symptoms and the need for antisecretory therapy. Weight loss was considered a secondary endpoint., Results: Fifty-eight patients were identified meeting inclusion criteria (LSG + HHR), with a mean follow-up of 97.5 weeks (range 44-172 weeks). The mean age of the cohort was 49.5 ± 11.2 years, with 74.1 % being female. Mean preoperative BMI was 44.2 ± 6.6 kg/m(2). Preoperative upper gastrointestinal contrast series was performed in all patients and demonstrated a hiatal hernia in 34.5 % of patients and reflux in 15.5 % of patients. Preoperatively, 44.8 % (n = 26) of patients reported subjective symptoms of reflux and/or required daily antisecretory therapy [Corrected]. After LSG + HHR, 34.6 % of symptomatic patients had resolution of their symptoms off therapy while the rest remained symptomatic and required daily antisecretory therapy; 84.4 % of patients that were asymptomatic preoperatively remained asymptomatic after surgery. New onset reflux symptoms requiring daily antisecretory therapy was seen in 15.6 % of patients who were previously asymptomatic. Post surgical weight loss did not correlate with the presence or resolution of reflux symptoms., Conclusion: Based on our data, LSG with concomitant HHR improved GERD symptoms or the need for daily antisecretory therapy only in a third of symptomatic patients. Furthermore, 15.6 % of asymptomatic patients developed de novo GERD symptoms despite a HHR. In patients with a documented hiatal hernia, HHR does not lead to GERD resolution or prevention after LSG, indicating the need for appropriate patient counseling and further study.

Background: The objective of this study was to assess whether the use of staple line reinforcement (SLR) reduces staple line complications (SLC). Mechanical staple lines are essential for gastrointestinal surgery such as bariatric surgery. However, SLC, such as bleeding and leakage, still occur. The purposes of this study were to provide quantitative evidence on the relative efficacy of gastric SLR and to compare the rates of effectiveness of three commonly used methods., Methods: A search of the medical literature in English language journals identified studies from Jan 1, 2000, to Dec 31, 2013, using the following reinforcement types: (1) no reinforcement, (2) oversewing, (3) a biocompatible glycolide copolymer, and (4) bovine pericardium after gastric bypasses and sleeve gastrectomies. Types of reinforcement were compared using a random-effects model., Results: This meta-analysis reviewed 16,967 articles, extracting data on 56,309 patients concerning leak and 41,864 patients concerning bleeding. Over 40 % of patients had no reinforcement, resulting in the highest leak rate (2.75 %) and bleed rate (3.45 %). Overall, reinforcing with bovine pericardium had the lowest leak (1.28 %) and bleed (1.23 %) rates. Suture oversewing was better than no reinforcement but not as effective as bovine pericardium for leak (2.45 %) and bleed (2.69 %) rates. Buttressing with a biocompatible glycolide copolymer resulted in the second highest leak rate (2.61 %) and a bleed rate of 2.48 % but had significantly lower bleed rates than no reinforcement., Conclusions: SLR provided superior results for patients compared to no reinforcement for reducing SLC. Buttressing with bovine pericardium resulted in the most favorable outcomes. The effectiveness of different methods used to reinforce the staple line in gastric surgery does not appear to be equal.

Background: Primary hyperparathyroidism (PHPT) in the setting of previous roux-en-Y gastric bypass (RYGBP) is not well described. The diagnosis can be difficult, as secondary hyperparathyroidism (SHPT) commonly occurs in patients after RYGBP due to calcium malabsorption and vitamin D deficiency., Methods: All patients from 2000 to 2012 who underwent cervical exploration for diagnosis of primary hyperparathyroidism with history of preceding RYGBP were identified and analyzed retrospectively., Results: Ten patients were identified. The average age was 58.4 and all patients were female. Time interval between RYGBP and cervical exploration was 67 months with median follow-up of 19 months. Average preoperative calcium was 10.8 mg/dL, PTH 155 pg/mL, and 25-vitamin-D 32 ng/mL. Eighty percent of patients presented with symptoms and 90% underwent preoperative imaging. Seventy percent underwent initial focused parathyroidectomy with 20% being converted to four-gland exploration. Seventy percent of patients had a single adenoma with two patients having multi-gland disease. Intraoperative PTH was used in seven patients with successful drop to 50% of baseline in all. Ninety percent of patients had greater then 6-month follow-up without evidence of persistent or recurrent PHPT. Average 6-month calcium was 9.3 mg/dL, PTH 73 pg/mL, and 25-vitamin-D 44 ng/ML. Four patients had evidence of persistently elevated PTH despite normalization of calcium., Conclusions: PHPT after RYGBP is rare but surgery with either a focused approach following successful localization or four-gland exploration is indicated when the biochemical diagnosis holds true. The presence of SHPT can make diagnosis and follow-up difficult and may predispose them to severe post-operative hypocalcemia.

Background: Small bowel obstruction after Roux-en-Y gastric bypass (RYGB) can be difficult to diagnose, but usually requires surgical treatment; clinical presentation may be nonspecific. Delay in diagnosis can result in catastrophic outcomes. Patients who present with small bowel obstruction after gastric bypass occasionally have pancreatic enzyme elevation and have been misdiagnosed as having acute pancreatitis. The objective of this study was to determine if there was an association between small bowel obstruction and an elevated amylase or lipase after RYGB., Methods: Ninety-nine cases of small bowel obstruction treated surgically were prospectively collected and retrospectively analyzed from a database of 4014 RYGB patients. Fifty-eight had a measurement of amylase or lipase at the time of operation., Results: An elevated amylase or lipase was found in 48% of all patients. These elevated rates were higher in an acute obstruction compared to those presenting with chronic symptoms (64% versus 28%; P=.007) and in obstruction involving the biliopancreatic limb compared to those that did not involve that limb (65% versus 21%; P<.001). These elevated rates were most notable in acute biliopancreatic limb obstruction compared to an acute obstruction not in the biliopancreatic limb (94% versus 27%; P<.001)., Conclusion: In RYGB patients, there is an association between small bowel obstruction and an elevated amylase or lipase. Acute obstruction of the biliopancreatic limb can be difficult to diagnose, and in these patients, the sensitivity of elevated amylase or lipase is very high. RYGB patients with abdominal pain should have their amylase and lipase measured. It is important to recognize that an elevation of these enzymes is not likely a result of acute pancreatitis., (Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background/objectives: Vagal block therapy (vBloc) is effective for moderate to severe obesity at one year., Subjects/methods: The ReCharge trial is a double-blind, randomized controlled clinical trial of 239 participants with body mass index (BMI) of 40 to 45 kg/m or 35 to 40 kg/m with one or more obesity-related conditions. Interventions were implantation of either vBloc or Sham devices and weight management counseling. Mixed models assessed percent excess weight loss (%EWL) and total weight loss (%TWL) in intent-to-treat analyses. At 18 months, 142 (88%) vBloc and 64 (83%) Sham patients remained enrolled in the study., Results: 18-month weight loss was 23% EWL (8.8% TWL) for vBloc and 10% EWL (3.8% TWL) for Sham (P < 0.0001). vBloc patients largely maintained 12-month weight loss of 26% EWL (9.7% TWL). Sham regained over 40% of the 17% EWL (6.4% TWL) by 18 months. Most weight regain preceded unblinding. Common adverse events of vBloc through 18 months were heartburn/dyspepsia and abdominal pain; 98% of events were reported as mild or moderate and 79% had resolved., Conclusions: Weight loss with vBloc was sustained through 18 months, while Sham regained weight between 12 and 18 months. vBloc is effective with a low rate of serious complications.

Background: Postoperative pulmonary complications (PPC) in bariatric surgery have not been well studied. Additionally, many bariatric patients suffer from the metabolic syndrome (MetS), contributing to surgical risk. We examined the incidence of PPC and MetS in a large national bariatric database. Furthermore, we analysed the relationships between morbidity, mortality, PPC, MetS, and several other comorbidities and also surgical factors., Methods: The Bariatric Outcomes Longitudinal Database (BOLD™) is a registry that includes up to 365 day outcomes. We analysed data between January 2008 and October 2010. The PPC tracked included pneumonia, atelectasis, pleural effusion, pneumothorax, adult respiratory distress syndrome, and respiratory failure. A composite pulmonary adverse event (CPAE) included the occurrence of any of these. MetS was defined as the combination of hypertension, dyslipidaemia, and diabetes mellitus. The association of MetS and additional comorbibities, procedural data, and patient characteristics with CPAEs was examined with appropriate statistical tests., Results: A total of 158 405 patients had a low incidence of PPC (0.91%) and a low mortality (0.6%) after bariatric surgery. MetS was prevalent in 12.7%, and was a significant risk factor for CPAE and mortality. Age, BMI, ASA physical status classification, surgical duration, procedure type, MetS (P<0.001), and additional comorbidities were significantly associated with CPAEs., Conclusions: The incidence of PPC was low after bariatric surgery. Increasing age, BMI, ASA status, MetS, obstructive sleep apnoea, asthma, congestive heart failure, surgical duration, and procedure type were independently significantly associated with PPC. Pulmonary complications and MetS were significantly associated with increased postoperative mortality., (© The Author 2014. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Importance: Although conventional bariatric surgery results in weight loss, it does so with potential short-term and long-term morbidity., Objective: To evaluate the effectiveness and safety of intermittent, reversible vagal nerve blockade therapy for obesity treatment., Design, Setting, and Participants: A randomized, double-blind, sham-controlled clinical trial involving 239 participants who had a body mass index of 40 to 45 or 35 to 40 and 1 or more obesity-related condition was conducted at 10 sites in the United States and Australia between May and December 2011. The 12-month blinded portion of the 5-year study was completed in January 2013., Interventions: One hundred sixty-two patients received an active vagal nerve block device and 77 received a sham device. All participants received weight management education., Main Outcomes and Measures: The coprimary efficacy objectives were to determine whether the vagal nerve block was superior in mean percentage excess weight loss to sham by a 10-point margin with at least 55% of patients in the vagal block group achieving a 20% loss and 45% achieving a 25% loss. The primary safety objective was to determine whether the rate of serious adverse events related to device, procedure, or therapy in the vagal block group was less than 15%., Results: In the intent-to-treat analysis, the vagal nerve block group had a mean 24.4% excess weight loss (9.2% of their initial body weight loss) vs 15.9% excess weight loss (6.0% initial body weight loss) in the sham group. The mean difference in the percentage of the excess weight loss between groups was 8.5 percentage points (95% CI, 3.1-13.9), which did not meet the 10-point target (P = .71), although weight loss was statistically greater in the vagal nerve block group (P = .002 for treatment difference in a post hoc analysis). At 12 months, 52% of patients in the vagal nerve block group achieved 20% or more excess weight loss and 38% achieved 25% or more excess weight loss vs 32% in the sham group who achieved 20% or more loss and 23% who achieved 25% or more loss. The device, procedure, or therapy-related serious adverse event rate in the vagal nerve block group was 3.7% (95% CI, 1.4%-7.9%), significantly lower than the 15% goal. The adverse events more frequent in the vagal nerve block group were heartburn or dyspepsia and abdominal pain attributed to therapy; all were reported as mild or moderate in severity., Conclusion and Relevance: Among patients with morbid obesity, the use of vagal nerve block therapy compared with a sham control device did not meet either of the prespecified coprimary efficacy objectives, although weight loss in the vagal block group was statistically greater than in the sham device group. The treatment was well tolerated, having met the primary safety objective., Trial Registration: clinicaltrials.gov Identifier: NCT01327976.

Background: Hypocalcemia is a potential complication after thyroidectomy. Patients with previous roux-en-Y gastric bypass (RYGBP) may be at increased risk for recalcitrant symptomatic hypocalcemia after thyroidectomy. This complication is poorly described and there is no current consensus on optimal management in this unique population., Methods: All patients from 2000 to 2012 who underwent thyroidectomy with history of preceding RYGBP were identified retrospectively. Each of the 19 patients meeting inclusion criteria were matched 2:1 for age, gender, and body mass index (BMI) to a cohort who underwent thyroidectomy without previous RYGBP. The study cohort and matched controls were compared for incidence of symptomatic postoperative hypocalcemia, requirement of intravenous (IV) calcium supplementation, and duration of hospital stay., Results: Age, proportion of female patients, and BMI were equivalent between cases (n = 19) and controls (n = 38). Comparison of primary outcomes demonstrated that the study group had a significantly higher incidence of symptomatic hypocalcemia (42% vs. 0%; P < .01), administration of IV calcium (21% vs. 0%; P < .01), and duration of hospital stay (2.2 vs. 1.2 days, P = .02)., Conclusion: Patients with previous RYGBP have a greater incidence of recalcitrant symptomatic hypocalcemia after thyroidectomy, resulting in prolonged duration of hospital stay. In this patient population, calcium levels should be closely monitored and early calcium and vitamin D supplementation initiated preemptively., (Copyright © 2013 Mosby, Inc. All rights reserved.)

With the dramatic increase in the prevalence of obesity worldwide and in the United States, it is virtually certain that clinicians will be caring for bariatric and obese nonbariatric patients in increasing numbers. This patient population presents several difficulties from the medical and surgical management perspectives. In particular, nutrition of the bariatric patient and critically ill obese patient is challenging. A clear understanding of the nutritional assessment and unique management strategies available for the bariatric and the critically ill obese patient is essential to provide them with the safest and most effective care., (Copyright © 2011 Elsevier Inc. All rights reserved.)

In response to external pressures and events that threatened to adversely affect the field of bariatric surgery, the American Society for Metabolic and Bariatric Surgery created a mechanism for certifying surgeons and their facilities to guarantee that bariatric surgery would be performed with the greatest degree of patient safety. Those surgeons and facilities that satisfied the requirements were designated as Bariatric Surgery Centers of Excellence (BSCOE). That process involved creating an independent, not-for-profit corporation, establishing the best practice criteria for certification, and developing the mechanism for evaluating surgeons and programs. After the successful implementation of this program, the American College of Surgeons introduced a similar program, Bariatric Surgery Center Network. It was believed that implementing a BSCOE program in the field of bariatric surgery would counteract the forces threatening to reduce patient access to surgery. Although some of the predicted benefits have been realized, many have not. Additionally, the process has been shown to be costly in terms of labor and monetary expense. The field of nutrition support has many similarities to bariatric surgery. Although no acute crisis threatens to adversely affect the field, leaders are considering the creation of a similar credentialing program. The decision to proceed with the development of a Nutrition Support Center of Excellence should be made after significant discussion centered on the potential benefits and problems related to such a program. The BSCOE process can be used as a successful model. This article reviews the issues leading up to the creation of the BSCOE, describes its certification process, mentions some of the benefits, and offers recommendations for the consideration of an NSCOE program.

Objective: To assess the cost-effectiveness of laparoscopic adjustable gastric banding (LAGB) and laparoscopic Roux-en-Y gastric bypass (LRYGB) as treatment for morbid obesity., Study Design: A Markov model was developed to simulate weight loss, health consequences, and costs for surgical treatment of morbid obesity. The model was used to estimate incremental cost-effectiveness ratios (ICERs) in terms of cost per quality-adjusted life-year (QALY) gained., Methods: Estimates of procedure effectiveness were derived from published results of a head-to-head randomized controlled trial. Other model parameters, including complication rates, costs of treatment, adverse events and obesity, mortality rates, and utilities, were estimated from published literature and publicly available databases. Costs (2006 US dollars) and QALYs were discounted by 3% per annum., Results: Under conservative assumptions, both LAGB and LRYGB improved health outcomes, at a higher cost, compared with no treatment. ICERs for both LAGB and LRYGB versus no treatment were below $25,000 per QALY gained. ICERs were lower for individuals with higher initial body mass index and higher for older individuals. ICERs for men were generally higher than those of women. Sensitivity analyses showed these results to be robust to reasonable variation in model parameters and overall parameter uncertainty. Base-case ICERs for LRYGB versus LAGB were below $25,000 per QALY gained, but were highly sensitive to model assumptions., Conclusion: Both LAGB and LRYGB provide significant weight loss and are cost-effective compared with no treatment at conventionally accepted thresholds for medical interventions.

Rapid shifts in the demographics and techniques of weight loss surgery (WLS) have led to new issues, new data, new concerns, and new challenges. In 2004, this journal published comprehensive evidence-based guidelines on WLS. In this issue, we've updated those guidelines to assure patient safety in this fast-changing field. WLS involves a uniquely vulnerable population in need of specialized resources and ongoing multidisciplinary care. Timely best-practice updates are required to identify new risks, develop strategies to address them, and optimize treatment. Findings in these reports are based on a comprehensive review of the most current literature on WLS; they directly link patient safety to methods for setting evidence-based guidelines developed from peer-reviewed scientific publications. Among other outcomes, these reports show that WLS reduces chronic disease risk factors, improves health, and confers a survival benefit on those who undergo it. The literature also shows that laparoscopy has displaced open surgery as the predominant approach; that government agencies and insurers only reimburse procedures performed at accredited WLS centers; that best practice care requires close collaboration between members of a multidisciplinary team; and that new and existing facilities require wide-ranging changes to accommodate growing numbers of severely obese patients. More than 100 specialists from across the state of Massachusetts and across the many disciplines involved in WLS came together to develop these new standards. We expect them to have far-reaching effects of the development of health care policy and the practice of WLS.

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 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.

Background: Several studies suggest patients with a body mass index (BMI; calculated as kg/m(2)) >or= 60 have a greater operative risk and so advocate a staged approach to bariatric procedures. This requires two separate operations and all associated risks. At our institution, we do not perform staged bariatric operations for these patients; we execute a single-stage laparoscopic Roux-en-Y gastric bypass (LGBP). Here, we analyze our experience in this population with a single-stage LGBP., Study Design: Ninety-five patients with a BMI >or= 60 were compared with 1,311 patients with BMI < 60 undergoing LGBP from December 2001 to May 2007. Data recorded included age, BMI, estimated blood loss, operating time, length of stay, and complications within the first 30 days after operation. Analyses of the data were performed using unpaired Student's t-test, with p < 0.05 as significant., Results: There were no statistically significant differences in age (42.6 versus 42.8 years), estimated blood loss (68.5 versus 69.5 mL), length of stay (3.1 versus 3.1 days), overall complications (12.7% versus 13.7%), or 30-day mortality (0.2% versus 0%) for patients with BMI < 60 as compared with patients with BMI >or= 60. The difference in operating time between the 2 groups was statistically significant (111 versus 118.7 minutes; p = 0.02) but likely reflected the learning curve., Conclusions: In our experience, there were no differences in the incidence of complications or mortality for patients with a BMI >or= 60 undergoing LGBP as compared with those with a BMI < 60. These high-risk patients can safely undergo a single-stage LGBP.

Background: To compare implantable gastric stimulation therapy with a standard diet and behavioral therapy regimen in a group of carefully selected class 2 and 3 obese subjects by evaluating the difference in the percentage of excess weight loss (EWL) between the control and treatment groups. The primary endpoint was the percentage of EWL from baseline to 12 months after randomization. Implantable gastric stimulation has been proposed as a first-line treatment for severely obese patients; however, previous investigations have reported inconclusive results., Methods: A total of 190 subjects were enrolled in this prospective, randomized, placebo-controlled, double-blind, multicenter study. All patients underwent implantation with the implantable gastric stimulator and were randomized to 1 of 2 treatment groups: the control group (stimulation off) or treatment group (stimulation on). The patients were evaluated on a monthly basis. All individuals who enrolled in this study agreed to consume a diet with a 500-kcal/d deficit and to participate in monthly support group meetings., Results: The procedure resulted in no deaths and a low complication rate. The primary endpoint of a difference in weight loss between the treatment and control groups was not met. The control group lost 11.7% +/- 16.9% of excess weight and the treatment group lost 11.8% +/- 17.6% (P = .717) according to an intent-to-treat analysis., Conclusion: Implantable gastric stimulation as a surgical option for the treatment of morbid obesity is a less complex procedure than current bariatric operations. However, the results of the present study do not support its application. Additional research is indicated to understand the physiology and potential benefits of this therapy.

Background: Several publications have suggested that staple line buttressing might decrease staple line bleeding, increase burst pressure, and decrease the likelihood of acute failure resulting in leak. Currently, permanent and nonpermanent options are available. However, concern has been raised about the permanent buttress material and its potential for delayed strip expulsion. This study analyzed our experience with 3 different buttressing materials for creating the gastric division during laparoscopic Roux-en-Y gastric bypass., Methods: From July 5, 2001 to May 30, 2007, 1451 consecutive patients underwent laparoscopic gastric bypass with buttressing material used for the stapled creation of the gastric pouch. Peristrips Dry (PSDs), permanent bovine pericardial strips, were used in 926 cases from July 5, 2001 to October 11, 2005. Seamguards, a synthetic bioabsorbable product, were used in 145 cases from November 2, 2004 to July 18, 2006, and PSD Veritas, remodelable, nonpermanent bovine pericardial strips, were placed in 380 patients from October 11, 2005 to May 30, 2007. All products were applied to the 60-mm-long, 3.5-mm cartridges of the EndoGIA II stapler. The ease of use, operative complications, visual bleeding, and postoperative leaks were recorded., Results: The patient characteristics were comparable for all groups. All products were easy to load on the stapler, and no operative complications related to the use of the buttress materials occurred. The incidence and severity of staple line bleeding was not specifically calculated but was visually noted to be minimal in all cases. Of the 3 groups, 4 contained leaks occurred in the Seamguards group, and all were successfully managed nonoperatively. No acute leaks were discovered in the PSD or PSD Veritas groups. This difference was statistically significant (p <.001)., Conclusion: Neither the PSDs or PSD Veritas group exhibited staple line complications. However, 4 leaks occurred in the patients who had Seamguards incorporated into their gastric pouch linear staple lines.

Objective: To evaluate the private third-party payer return on investment for bariatric surgery the United States., Study Design: Morbidly obese patients aged 18 years or older were identified in an employer claims database of more than 5 million beneficiaries (1999-2005) using International Classification of Diseases, Ninth Revision, Clinical Modification code 278.01. Each of 3651 patients who underwent bariatric surgery during this period was matched to a control subject who was morbidly obese and never underwent bariatric surgery. Bariatric surgery patients and controls were matched based on patient demographics, selected comorbidities, and costs., Methods: Total healthcare costs for bariatric surgery patients and their controls were recorded for 6 months before surgery through the end their continuous enrollment. To account for potential differences in patient characteristics, we calculated the cost differential by estimating a Tobit model. A return on investment was estimated from the resulting coefficients. Costs were inflation adjusted to 2005 US dollars using the Consumer Price Index for Medical Care, and the cost savings were discounted by 3.07%, the month Treasury bill rate during the same period., Results: The mean bariatric surgery investment ranged from approximately $17,000 to $26,000. After controlling for observable patient characteristics, we estimated all costs to have been recouped within 2 years for laparoscopic surgery patients and within 4 years for open surgery patients., Conclusions: Downstream savings associated with bariatric surgery are estimated to offset the initial costs in 2 to 4 years. Randomized or quasiexperimental studies would be useful to confirm this conclusion, as unobserved characteristics may influence the decision to undergo surgery and cannot be controlled for in this analysis.

Background: Aiming to clarify the mechanism of weight loss after the restrictive bariatric procedure of sleeve gastrectomy (LSG), the volumes and pressures of the stomach, of the removed part, and of the remaining sleeve were measured in 20 morbidly obese patients., Methods: The technique used consisted of occlusion of the pylorus with a laparoscopic clamp and of the gastroesophageal junction with a special orogastric tube connected to a manometer. Instillation of methylene-blue-colored saline via the tube was continued until the intraluminal pressure increased sharply, or the inflated stomach reached 2,000 cc. After recording of measurements, LSG was performed., Results: Mean volume of the entire stomach was 1,553 cc (600-2,000 cc) and that of the sleeve 129 cc (90-220 cc), i.e., 10% (4-17%) and that of the removed stomach was 795 cc (400-1,500 cc). The mean basal intragastric pressure of the whole stomach after insufflations of the abdominal cavity with CO(2) to 15 mmHg was 19 mmHg (11-26 mmHg); after occlusion and filling with saline it was 34 mmHg (21-45 mmHg). In the sleeved stomach, mean basal pressure was similar 18 mmHg (6-28 mmHg); when filled with saline, pressure rose to 43 mmHg (32-58 mmHg). The removed stomach had a mean pressure of 26 mmHg (12-47 mmHg). There were no postoperative complications and no mortality., Conclusions: The notably higher pressure in the sleeve, reflecting its markedly lesser distensibility compared to that of the whole stomach and of the removed fundus, indicates that this may be an important element in the mechanism of weight loss.

The increasing use of bariatric procedures in the treatment of morbidly obese patients means that aesthetic plastic surgeons can expect to care for more and more patients who have undergone bariatric surgery. It is important for aesthetic surgeons to understand the procedures, outcomes, and possible complications to recognize the signs and symptoms of any potential problems. Candidates for bariatric surgery must have a body mass index (BMI) of at least 40 kg/m(2) or a BMI of 35 kg/m(2) with at least one comorbidity, plus demonstrated failure of nonsurgical means of weight control to control weight and no significant psychiatric disorders. Surgical procedures can be categorized as restrictive or malabsorptive and include adjustable gastric band, Roux-en-Y gastric bypass, and biliopancreatic diversion with or without duodenal switch. There are no definitive criteria for choosing any single procedure, although in general restrictive procedures may be more appropriate for those patients with lower BMIs and malabsorptive procedures for those with higher BMIs. Results of bariatric surgery are impressive and include not only significant and sustained weight loss but also improvement or resolution of major comorbid conditions. Significant complications include anastomotic leak, marginal ulceration, and internal herniation, as well as wound infection, incisional hernia, hemorrhage, deep venous thrombosis, and pulmonary embolus. Innovative procedures now under study include gastrointestinal neuromodulation, sleeve gastrectomy, intragastric balloons, intraluminal sleeves, and other endoscopic procedures.

Hypothesis: Laparoscopic Roux-en-Y gastric bypass is a complex procedure performed on a high-risk patient population. Good results can be attained with experience and volume., Design: Retrospective study., Setting: Tertiary care academic hospital., Patients: Seven hundred fifty consecutive morbidly obese patients undergoing surgery from March 1998 to April 2004., Interventions: All patients underwent laparoscopic Roux-en-Y gastric bypass., Main Outcome Measures: Perioperative deaths and complications., Results: The patient population was 85% women and had a mean body mass index of 47 kg/m2 (range, 32-86 kg/m2). The overall complication rate was 15% and the mortality was 0.3%. For the first 100 cases, the overall complication rate was 26% with a mortality of 1%. This complication rate decreased to approximately 13% and was stable for the next 650 patients. The incidence of major complications has also decreased since the first 100 cases. Leak decreased from 3% to 1.1%. Small-bowel obstruction decreased from 5% to 1.1%. Overall mean operating time was 138 minutes (range, 65-310 minutes). It decreased from 212 minutes for the first 100 cases to 132 minutes for the next 650 and 105 minutes (range, 65-200 minutes) for the last 100 cases., Conclusions: Laparoscopic Roux-en-Y gastric bypass is a technically difficult operation. This review of a large series in a high-volume program demonstrated that the morbidity and mortality could be reduced by 50% with experience. The results are similar to those reported from other major centers. In addition, as reported elsewhere, the learning curve for this procedure may be 100 cases.

Background: The consequences of a staple-line leak or disruption can be devastating particularly in the bariatric surgery population. This study was designed to assess if gastrointestinal staple-lines buttressed with bovine pericardium could tolerate greater intraluminal pressures compared with non-reinforced staple-lines., Methods: A laparoscopic linear cutting staple device was used to create divided staple-lines across the small intestine in a porcine model and the stomach in a rabbit model. 21 staple-lines were created with buttressing strips of bovine pericardium, and another 21 staple-lines were created without any reinforcement. All staple-lines were subjected to a constant rate increase in intraluminal pressure via intraluminal infusion of a dye solution. At the first sign of seam leak or failure, the burst pressure was recorded., Results: In 19 of the 21 studies, the staple-lines buttressed with bovine pericardium sustained higher mean burst pressures than the conventional non-buttressed staple-lines. For the porcine intestinal segments, the mean intraluminal pressure at failure was 125 +/- 24 mmHg for buttressed staple-lines versus 58.4 +/- 28 mm Hg for conventional staple-lines (P <0.0001). For rabbit stomach segments, the mean intraluminal pressure at failure was also significantly higher for the buttressed segments (115 +/- 24 vs 75.6 +/- 23, P <0.0137). Most buttressed segments failed away from the staple-line, while the non-buttressed segments failed at the staple-line., Conclusions: Gastrointestinal staple-lines buttressed with bovine pericardium are able to maintain seam integrity at significantly higher intraluminal pressures when compared to non-buttressed GI staple-lines in animal models.

Divided linear staple-lines are a mainstay of gastrointestinal surgery, and in particular, bariatric surgery. Staple-line failure, although uncommon, can result in significant morbidity and even mortality. Staple-line buttressing has been developed to improve staple-line strength, decrease bleeding and minimize the risk of leak. Many different products are currently available. However, most have not been proven in clinical trials. Bovine pericardial strips (BPS) are a buttressing material that fits onto the stapler device and gets "stapled" onto the tissue when the device is fired. The strips add thickness and potentially strength to the staple-line. Animal research has shown that staple-lines incorporated with BPS had higher burst pressures than those without. Human experience has suggested that BPS decreased the risk of acute staple-line failures in laparoscopic Roux-en-Y gastric bypass surgery. This report reviews the clinical and research experience with this product.

Background: The prevalence of obesity is growing worldwide. Medical therapies are often ineffective, and surgical treatments have significant risk. IGS(R) offers a novel approach to weight loss that was found to be safe and effective in European trials. In the U.S., 2 consecutive trials have been undertaken., Methods: In 2000, a multicenter, prospective, randomized, placebo-controlled trial involving 103 morbidly obese patients (U.S. O-01) was undertaken. In 2002, a prospective, open label trial involving 30 morbidly obese patients was initiated (DIGEST). Patients were followed for complications, postoperative untoward events, and weight loss., Results: In O-01, there were no significant perioperative complications. However, 20 patients were found to have had lead dislodgements. At 7 months, there was no significant difference in weight loss between the activated and non-activated groups. After 29 months, loss of excess weight (EWL) approached 20%. With DIGEST, there was 1 operative complication (a lost needle retrieved surgically). There were no untoward events or known lead dislodgements. EWL was 23% after only 16 months follow-up. With the introduction of a preoperative screening algorithm, almost 40% EWL was achieved for selected patients in both trials., Conclusions: In the U.S., the IGS system for the treatment of obesity has been shown to be safe. Technical improvements and better patient selection resulted in improved weight loss. The preliminary results of these trials suggest that IGS may be a suitable surgical option for selected patients.

Implantable Gastric Stimulation is a safe and minimally invasive surgical therapy currently under investigation for the treatment for severe obesity. Over 500 patients have been implanted internationally, and thus far, there have been no major complications or mortalities. While this technology is proving to be the least morbid of the bariatric surgical procedures, it still has the potential to result in devastating complications because of the high-risk nature of operating on severely obese patients. Keeping the risk of a complication to a minimum requires careful attention to preoperative patient preparation, good operative technique, and comprehensive perioperative patient care. In addition, like for all bariatric procedures, the program must have the appropriate equipment and resources to serve this unique patient population. This review will highlight the most significant aspects of each issue.

To test the hypothesis that total energy expenditure (TEE) and resting energy expenditure (REE) are low in extremely obese individuals, factors that could contribute to maintenance of excess weight, a cross-sectional study was conducted in 30 weight stable, extremely obese women [BMI (mean +/- SEM) 48.9 +/- 1.7 kg/m(2)]. TEE was measured over 14 d using the doubly labeled water method, REE and the thermic effect of feeding (TEF) were measured using indirect calorimetry, and activity energy expenditure (AEE) was calculated as TEE - (REE + TEF). Body composition was determined using a 3-compartment model. Subjects were divided into tertiles of BMI (37.5-45.0; 45.1-52.0; and 52.1-77.0 kg/m(2)) for data analysis. TEE and REE increased with increasing BMI tertile: TEE, 12.80 +/- 0.5, 14.67 +/- 0.5, and 16.10 +/- 0.9 MJ/d (P < 0.01); REE, 7.87 +/- 0.2, 8.78 +/- 0.3, and 9.94 +/- 0.6 MJ/d (P < 0.001), and these values were 29-38% higher than published means of measured TEE in nonobese individuals. No significant differences were observed among BMI tertiles for AEE, TEF, or physical activity level (PAL = TEE/REE, overall mean 1.64 +/- 0.16). The Harris-Benedict and WHO equations provided the closest estimates of REE (within 3%), whereas the obese-specific equations of Ireton-Jones overpredicted (40%) and Bernstein underpredicted (21%) REE. Extremely obese individuals have high absolute values for TEE and REE, indicating that excess energy intake contributes to the maintenance of excess weight. Standard equations developed for nonobese populations provided the most accurate estimates of REE for the obese individuals studied here. REE was not accurately predicted by equations developed in obese populations.

With the epidemic of obesity worldwide, bariatric surgery has rapidly grown in popularity. Currently, a variety of surgical procedures are performed including Roux-en-Y gastric bypass, laparoscopic adjustable gastric banding, vertical banded gastroplasty, and biliopancreatic diversion. All of these procedures have been shown to succeed in achieving significant and sustainable weight loss for the majority of patients. However, these procedures also carry the potential for serious operative morbidity, altered gastrointestinal anatomy or function, or both. Electrical gastric stimulation via the implantable gastric stimulation (IGS) system is a relatively new and novel approach to treat obesity. The operative technique is relatively simple and the system does not alter gastrointestinal anatomy. Preliminary worldwide investigations have demonstrated safety and efficacy. This article will review the current experience with the IGS system.

The prevalence of obesity is growing worldwide at an alarming rate. Current medical therapies are often ineffective and surgical treatments result in weight loss but have significant risk. Implantable Gastric Stimulation (IGS) offers a novel approach to weight loss. Simply stated, the IGS system electrically stimulates the stomach with a pacemaker-like device. The device is implanted in a brief minimally invasive procedure. Investigation in over 500 patients globally has proven it to be safe and seemly free of long-term sequelae. With refinements in patient selection and device application, the weight loss results have been steadily improving. The IGS may someday become a reliable and safe surgical option for weight loss.

Background: Little is known about the determinants of individual variability in body weight and fat loss after gastric bypass surgery or about the effects of massive weight loss induced by this surgery on energy requirements., Objectives: The objectives were to determine changes in energy expenditure and body composition with weight loss induced by gastric bypass surgery and to identify presurgery predictors of weight loss., Design: Thirty extremely obese women and men with a mean (+/- SD) age of 39.0 +/- 9.6 y and a body mass index (BMI; in kg/m(2)) of 50.1 +/- 9.3 were tested longitudinally under weight-stable conditions before surgery and after weight loss and stabilization (14 +/- 2 mo). Total energy expenditure (TEE), resting energy expenditure (REE), body composition, and fasting leptin were measured., Results: Subjects lost 53.2 +/- 22.2 kg body weight and had significant decreases in REE (-2.4 +/- 1.0 MJ/d; P < 0.001) and TEE (-3.6 +/- 2.5 MJ/d; P < 0.001). Changes in REE were predicted by changes in fat-free mass and fat mass. The average physical activity level (TEE/REE) was 1.61 at both baseline and follow-up (P = 0.98). Weight loss was predicted by baseline fat mass and BMI but not by any energy expenditure variable or leptin. Measured REE at follow-up was not significantly different from predicted REE., Conclusions: TEE and REE decreased by 25% on average after massive weight loss induced by gastric bypass surgery. REE changes were predicted by loss of body tissue; thus, there was no significant long-term change in energy efficiency that would independently promote weight regain.

Body composition methods were examined in 20 women [body mass index (BMI) 48.7 +/- 8.8 kg/m(2)] before and after weight loss [-44.8 +/- 14.6 (SD) kg] after gastric bypass (GBP) surgery. The reference method, a three-compartment (3C) model using body density by air displacement plethysmography and total body water (TBW) by H(2)18O dilution (3C-H(2)18O), showed a decrease in percent body fat (%BF) from 51.4 to 34.6%. Fat-free mass hydration was significantly higher than the reference value (0.738) in extreme obesity (0.756; P < 0.001) but not after weight reduction (0.747; P = 0.16). %BF by H(2)18O dilution and air displacement plethysmography differed significantly from %BF by 3C-H(2)18O in extreme obesity (P < 0.05) and 3C models using (2)H(2)O or bioelectrical impedance analysis (BIA) to determine TBW improved mean %BF estimates over most other methods at both time points. BIA results varied with the equation used, but BIA better predicted %BF than did BMI at both time points. All methods except BIA using the Segal equation were comparable to the reference method for determining changes over time. A simple 3C model utilizing air displacement plethysmography and BIA is useful for clinical evaluation in this population.

Background: Staple-line leakage is a potentially devastating complication of Roux-en-Y gastric bypass (RYGBP). Bovine pericardial strips (BPS) have been used to reinforce staple-lines in pulmonary resections and have been shown to decrease air-leaks. This study examined the use of BPS to decrease gastric staple-line leaks., Methods: 250 consecutive patients undergoing laparoscopic RYGBP had BPS used for the gastric pouch. Ease of use, operative complications, and visual bleeding were recorded. In addition, the postoperative leak rate was compared to 100 consecutive patients operated on prior to the study when BPS was not used., Results: Patient characteristics were the same for both groups and comparable with most published data. With the use of BPS, there were no operative complications and no meaningful increase in operating time. BPS reinforced staple-lines had no visual bleeding. In the 100 cases without BPS, there were 2 staple-line leaks (2%) both of which required emergency exploration. One additional patient was subsequently found to have a gastrogastric fistula. In the 250 patients who had BPS-reinforced staple-lines, there were no acute leaks. Three patients were subsequently found to have gastrogastric fistula. None required emergency surgery., Conclusion: In this non-randomized trial, BPS were found to be easy and safe to use. In addition, staple-line hemorrhage was essentially non-existent. Although the reduction in gastric staple-line leak rate may also be attributed to learning curve, there were no acute leaks in 250 patients with BPS, which is below the published norms.

Morbid obesity is defined as obesity with a body mass index >/=40, or >/=35 with secondary serious diseases. Conservative medical therapies in these individuals generally fail to sustain weight loss. Thus, surgical operations have evolved which are based on gastric restriction and/or malabsorption. Historically, the intestinal bypass operation was followed by the gastric bypass operation (in some instances combined with intestinal bypass) or by the gastric restriction operations (gastroplasty or gastric banding). Laparoscopic techniques are now being used for these operations, but require surgical expertise in both the bariatric operations and advanced laparoscopic skills. All operations may have complications, but these occur in a very small percent. Postoperative follow-up and nutritional surveillance are mandatory. The operations result in significant weight loss, and the current operations have a mean lasting weight loss of about 50 percent of excess body weight, with improvement or resolution of most obesity-associated conditions. There is evidence that even modest to moderate weight loss in these individuals has significant medical benefit.

As with all critically ill patients, those requiring mechanical ventilation are susceptible to the wasting of illness and cannot survive without prompt nutritional support. It may be fair to say that the proper provision of nutrients, and in particular the avoidance of overfeeding, are even more crucial for this subset of critically ill patients. To maximize the overall benefits of feeding, it is crucial to provide the nutritional support early and enterally whenever possible. Therefore, the best strategy for early removal of the mechanical ventilatory support must include the timely and careful administration of nutrients, micronutrients, minerals, vitamins, and fluid, in conjunction with standard intensive care therapeutics and the appropriate respiratory muscle-strengthening program.