Wendy A. Brown

The Laparoscopic Adjustable Gastric Band (Lap-Band®): A Prospective Study of Medium-Term Effects on Weight, Health and Quality of Life

Background: Obesity is now one of our major public health problems. Effective and acceptable treatment options are needed.The Lap-Band® system is placed laparoscopically and allows adjustment of the level of gastric restriction. Methods: A prospective study of 709 severely obese patients was conducted over a 6-year period at a university-based multidisciplinary referral center. After extensive preoperative evaluation, patients with a body mass index >35 were treated by LapBand® placement. Close follow-up with progressive adjustment of gastric restriction continued permanently. Medical co-morbidities were monitored as part of comprehensive prospective data collection. Results: There have been no deaths perioperatively or during follow-up. Significant perioperative adverse events occurred in 1.2% only. Reoperation has been needed for prolapse (slippage) in 12.5%, erosion of the band into the stomach in 2.8% and for tubing breaks in 3.6%. A steady progression of weight loss has occurred through the duration of the study with 52 ± 19 %EWL at 24 months (n=333), 53±22 %EWL at 36 months (n=264), 52 ± 24 %EWL at 48 months (n=108), 54 ± 24 %EWL at 60 months (n=30), and 57 ± 15% EWL at 72 months (n=10). Major improvements have occurred in diabetes, asthma, gastroesophageal reflux, dyslipidemia, sleep apnea and depression. Quality of life as measured by Rand SF-36 shows highly significant improvement. Conclusions: Placement of the Lap-Band® system provides safe and effective control of severe obesity. The effect on weight loss is durable and is associated with major improvement in health and quality of life. It has the potential to provide a broadly acceptable option for this common and serious disease.

Long-term outcomes after bariatric surgery : fifteen-year follow-up of adjustable gastric banding and a systematic review of the bariatric surgical literature

Objective:To describe the long-term outcomes after laparoscopic adjustable gastric banding (LAGB) and compare these with the published literature on bariatric surgery. Background:Because obesity is a chronic disease, any proposed obesity treatment should be expected to demonstrate long-term durability to be considered effective. Yet for bariatric surgery, few long-term weight loss data are available. We report our 15-year follow-up data after LAGB and provide a systematic review of the peer-reviewed literature for weight loss at 10 years or more after bariatric surgical procedures. Methods:We performed a prospective longitudinal cohort study of LAGB patients using an electronic database system (LapBase) to track progress, measure weight changes, and document revisional procedures. The evolution of the LAGB procedure was recognized, and revisional rates for 3 separate periods between September 1994 and December 2011 were described. In addition, we performed a systematic review of the peer-reviewed published literature collecting all reports that included weight loss data at or beyond 10 years. Results:A total of 3227 patients, with a mean age of 47 years and a mean body mass index of 43.8 kg/m2, were treated by laparoscopic adjustable gastric band placement between September 1994 and December 2011. Seven hundred fourteen patients had completed at least 10 years of follow-up. Follow-up was intact in 81% of patients overall and 78% of those beyond 10 years. There was no perioperative mortality for the primary placement or for any revisional procedures. There was 47.1% of excess weight loss (% EWL) at 15 years [n = 54; 95% confidence interval (CI) = 8.3] and 62% EWL at 16 years (n = 14; 95% CI = 13.6). There was a mean of 47.0% EWL (n = 714; 95% CI = 1.3) for all patients who were at or beyond 10 years follow-up. Revisional procedures were performed for proximal enlargement (26%), erosion (3.4%), and port and tubing problems (21%). The band was explanted in 5.6%. The need for revision decreased as the technique evolved, with 40% revision rate for proximal gastric enlargements in the first 10 years, reducing to 6.4% in the past 5 years. The revision group showed a similar weight loss to the overall group beyond 10 years. The systematic review of all bariatric procedures with 10 or more years of follow-up showed greater than 50% EWL for all current procedures. The weighted mean at maximum follow-up for LAGB was 54.2% EWL and for Roux-en-Y gastric bypass was 54.0% EWL. Conclusions:The LAGB study from 1 center demonstrates a durable weight loss with 47% EWL maintained to 15 years. This weight loss occurred regardless of whether any revisional procedures were needed. A systematic review shows substantial and similar long-term weight losses for LAGB and other bariatric procedures.

Pro-Inflammatory CD11c+CD206+ Adipose Tissue Macrophages Are Associated With Insulin Resistance in Human Obesity

OBJECTIVE Insulin resistance and other features of the metabolic syndrome have been causally linked to adipose tissue macrophages (ATMs) in mice with diet-induced obesity. We aimed to characterize macrophage phenotype and function in human subcutaneous and omental adipose tissue in relation to insulin resistance in obesity. RESEARCH DESIGN AND METHODS Adipose tissue was obtained from lean and obese women undergoing bariatric surgery. Metabolic markers were measured in fasting serum and ATMs characterized by immunohistology, flow cytometry, and tissue culture studies. RESULTS ATMs comprised CD11c+CD206+ cells in “crown” aggregates and solitary CD11c−CD206+ cells at adipocyte junctions. In obese women, CD11c+ ATM density was greater in subcutaneous than omental adipose tissue and correlated with markers of insulin resistance. CD11c+ ATMs were distinguished by high expression of integrins and antigen presentation molecules; interleukin (IL)-1β, -6, -8, and -10; tumor necrosis factor-α; and CC chemokine ligand-3, indicative of an activated, proinflammatory state. In addition, CD11c+ ATMs were enriched for mitochondria and for RNA transcripts encoding mitochondrial, proteasomal, and lysosomal proteins, fatty acid metabolism enzymes, and T-cell chemoattractants, whereas CD11c− ATMs were enriched for transcripts involved in tissue maintenance and repair. Tissue culture medium conditioned by CD11c+ ATMs, but not CD11c− ATMs or other stromovascular cells, impaired insulin-stimulated glucose uptake by human adipocytes. CONCLUSIONS These findings identify proinflammatory CD11c+ ATMs as markers of insulin resistance in human obesity. In addition, the machinery of CD11c+ ATMs indicates they metabolize lipid and may initiate adaptive immune responses.

Laparoscopic Adjustable Gastric Banding in Severely Obese Adolescents: A Randomized Trial

CONTEXT Adolescent obesity is a common and serious health problem affecting more than 5 million young people in the United States alone. Bariatric surgery is being evaluated as a possible treatment option. Laparoscopic adjustable gastric banding (gastric banding) has the potential to provide a safe and effective treatment. OBJECTIVE To compare the outcomes of gastric banding with an optimal lifestyle program on adolescent obesity. DESIGN, SETTING, AND PATIENTS A prospective, randomized controlled trial of 50 adolescents between 14 and 18 years with a body mass index (BMI) higher than 35, recruited from the Melbourne, Australia, community, assigned either to a supervised lifestyle intervention or to undergo gastric banding, and followed up for 2 years. The study was performed between May 2005 and September 2008. MAIN OUTCOME MEASURES Weight loss. Secondary outcomes included change in metabolic syndrome, insulin resistance, quality of life, and adverse outcomes. RESULTS Twenty-four of 25 patients in the gastric banding group and 18 of 25 in lifestyle group completed the study. Twenty-one (84%) in the gastric banding and 3 (12%) in the lifestyle groups lost more than 50% of excess weight, corrected for age. Overall, the mean changes in the gastric banding group were a weight loss of 34.6 kg (95% CI, 30.2-39.0), representing an excess weight loss of 78.8% (95% CI, 66.6%-91.0%), 12.7 BMI units (95% CI, 11.3-14.2), and a BMI z score change from 2.39 (95% CI, 2.05-2.73) to 1.32 (95% CI, 0.98-1.66). The mean losses in the lifestyle group were 3.0 kg (95% CI, 2.1-8.1), representing excess weight loss of 13.2% (95% CI, 2.6%-21.0%), 1.3 BMI units (95% CI, 0.4-2.9), and a BMI z score change from 2.41 (95% CI, 2.21-2.66) to 2.26 (95% CI, 1.91-2.43). At entry, 9 participants (36%) in the gastric banding group and 10 (40%) in the lifestyle group had the metabolic syndrome. At 24 months, none of the gastric banding group had the metabolic syndrome (P = .008; McNemar chi(2)) compared with 4 of the 18 completers (22%) in the lifestyle group (P = .13). The gastric banding group experienced improved quality of life with no perioperative adverse events. However, 8 operations (33%) were required in 7 patients for revisional procedures either for proximal pouch dilatation or tubing injury during follow-up. CONCLUSIONS Among obese adolescent participants, use of gastric banding compared with lifestyle intervention resulted in a greater percentage achieving a loss of 50% of excess weight, corrected for age. There were associated benefits to health and quality of life. TRIAL REGISTRATION ANZCTR Identifier: 12605000160639.

Systematic Review of Erosion after Laparoscopic Adjustable Gastric Banding

Erosion of the laparoscopic adjustable gastric band (LAGB) into the lumen of the stomach is a recognised complication of this procedure. We undertook a systematic literature review of the incidence, clinical features and management of erosions occurring after LAGB. A systematic search of relevant medical databases for full-text original articles looking for LAGB patients and reported erosions was conducted. We focussed on incidence, aetiology, clinical presentation, treatment, complications and weight loss. Twenty-five studies of LAGB reported 231 erosions in 15,775 patients (overall incidence of 1.46%). The mean number of patients per study was 631 (±486), and the mean follow-up was 3.73 (±2.4) years. In four reports involving less than 100 patients, there were 27 erosions in a total of 270 patients (10%) compared with 180 erosions in 12,978 patients (1.386%) in the remaining 21 reports. Multiple regression analysis showed that erosion rate was significantly predicted by number of patients and number of years of surgeon experience (r2 = 0.186). Treatment was most commonly by removal of the band, repair of the stomach and later, band replacement. Other options were removal alone or conversion to another procedure. Weight loss was retained after treatment of the erosion with a mean weight loss at final follow-up of 50.34 ± 3.9 percent excess weight loss. Incidence of erosion after gastric banding is relatively low and can be related to surgeon experience. The most common treatment described in the literature is removal of the eroded band with delayed replacement. Replacement of the band is associated with maintenance of weight loss.

Multidisciplinary diabetes care with and without bariatric surgery in overweight people: a randomised controlled trial.

BACKGROUND Bariatric surgery improves glycaemia in obese people with type 2 diabetes, but its effects are uncertain in overweight people with this disease. We aimed to identify whether laparoscopic adjustable gastric band surgery can improve glucose control in people with type 2 diabetes who were overweight but not obese. METHODS We did an open-label, parallel-group, randomised controlled trial between Nov 1, 2009, and June 30, 2013, at one centre in Melbourne, Australia. Patients aged 18-65 years with type 2 diabetes and a BMI between 25 and 30 kg/m2 were randomly assigned (1:1), by computer-generated random sequence, to receive either multidisciplinary diabetes care plus laparoscopic adjustable gastric band surgery or multidisciplinary diabetes care alone. The primary outcome was diabetes remission 2 years after randomisation, defined as glucose concentrations of less than 7.0 mmol/L when fasting and less than 11.1 mmol/L 2 h after 75 g oral glucose, at least two days after stopping glucose-lowering drugs. Analysis was by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000286246. FINDINGS 51 patients were randomised to the multidisciplinary care plus gastric band group (n=25) or the multidisciplinary care only group (n=26), of whom 23 participants and 25 participants, respectively, completed follow-up to 2 years. 12 (52%) participants in the multidisciplinary care plus gastric band group and two (8%) participants in the multidisciplinary care only group achieved diabetes remission (difference in proportions 0.44, 95% CI 0.17-0.71; p=0.0012). One (4%) participant in the gastric band group needed revisional surgery and four others (17%) had a total of five episodes of food intolerance due to excessive adjustment of the band. INTERPRETATION When added to multidisciplinary care, laparoscopic adjustable gastric band surgery for overweight people with type 2 diabetes improves glycaemic control with an acceptable adverse event profile. Laparoscopic adjustable gastric band surgery is a reasonable treatment option for this population. FUNDING Monash University Centre for Obesity Research and Education and Allergan.

OBESITY IS A SURGICAL DISEASE: OVERVIEW OF OBESITY AND BARIATRIC SURGERY

Obesity is a disease in which fat has accumulated to the extent that health may be affected. By common practice, a body mass index (BMI) above 30 is considered obese although there is an increased risk of premature death associated with a BMI over 27. The problem of obesity is common worldwide and is increasing rapidly. The World Health Organization estimates that there are more than 1.1 billion overweight adults in the world and over 300 million are obese. 1 In Australia, the number of obese has doubled in the last 20 years. 2 The number of people afflicted is so great that the only logical solution at a community level is prevention. However, the steady increase in prevalence indicates that the current preventive strategies have not yet begun to have an effect. In the meantime, those with an established problem of obesity need help. Obesity is the worst pathogen that we have in our community today because of the broad range of other diseases that it causes or makes worse. Type 2 diabetes is the paradigm of an obesity related disease. It is common, affecting around 1 million Australians; it is lethal and it is largely a consequence of excess weight. Reduction in weight is its most powerful treatment. If we just focused on diabetes alone, we could justify placing enormous effort and expenditure into managing the weight problem that causes it. However, there are many other health problems almost equally justifying major effort to treat obesity. Common diseases which are caused or made worse by obesity include hypertension, dyslipidaemia, heart disease, stroke, degenerative disease of the back and weight bearing joints, nonalcoholic steatohepatitis, sleep apnoea and other sleep disordered breathing problems, reflux oesophagitis and infertility. Through the impact of these diseases, obesity is killing more and more people. The Surgeon-General of the USA recently accepted the data from multiple large cohort studies showing an annual mortality from obesity related diseases of 300 000 people per year. 3 The number is increasing and is soon expected to pass that of smoking related diseases that are now on the decrease. It will have the dubious distinction of being the leading preventable cause of death. The medical treatment of obesity is relatively ineffective. Optimal application of a programme of best practice for healthy eating, exercise, behavioural modification, supplemented by drug therapy, might lead to a weight loss of up to 10 kg, if applied continuously. This amount of weight loss is usually insufficient for effective treatment of obesity and its comorbidities and optimal and continuous application of the programme is rarely achieved. Only two drugs – orlistat and sibutramine – are currently available for long-term weight reduction and systematic review of multiple controlled clinical trials shows poor compliance and effect with losses of only 2.7 and 4.3 kg, respectively, after 12 months of treatment. 4

Revisional Surgery for Morbid Obesity - Conversion to the Lap-Band® System

Background:The safety and effectiveness of conversion to the Lap-Band® system‚ of patients who had failure of adequate weight loss and/or severe symptoms from prior bariatric procedures has been measured by prospective evaluation of a consecutive group of 50 patients. Methods:The patients were drawn as a subgroup of 713 patients who had placement of the Lap-Band system between July 1994 and May 2000.The preceding procedures were gastroplasty (35 patients), nonadjustable gastric banding (11), gastric bypass (2) and jejuno-ileal bypass (2). All operations were by open laparotomy. Initial reversal of the initial procedure was performed in 28 patients. M:F ratio was 6%/94%. Inadequate weight was the primary problem in 69%, and symptoms of obstruction were present in 31%. Results: Significant perioperative complications occurred more frequently than after primary placement (17% vs 1.1%). However, late complications were less frequent (2% vs 18%). In particular, there have been no occurrences of prolapse (slippage) of the stomach through the band or erosion of the band into the stomach in this group to date. Weight loss of 47% of excess weight had occurred at 3-year followup. This is not significantly different from the 53% EWL in the primary Lap-Band group. All symptoms of obstruction were relieved by the revision, and a number of comorbidities are seen to be markedly improved. Conclusions: We observe that, when compared to primary Lap-Band placement, revision of failed bariatric procedures to Lap-Band is associated with more perioperative adverse events but fewer late complications. Weight loss is equivalent and is associated with marked improvement in comorbidities and quality of life.The outcomes are better than have been achieved by revision to another form of gastric stapling and should be considered in those patients who have had an unsatisfactory outcome from other bariatric procedures.

A systematic review of the impact of weight loss on cancer incidence and mortality.

Obesity is well recognized as a significant risk factor for certain cancers; however, a corresponding risk reduction with weight loss is not yet clearly defined. This review aims to examine the literature investigating the effect of all types of weight loss on cancer incidence and mortality, and to more clearly describe the relationship between these two factors. A literature search identified 34 publications reporting weight loss data in relation to cancer incidence or mortality. All except one were observational studies and the majority used self‐reported weights and did not define intentionality of weight loss. 16/34 studies found a significant inverse association between weight loss and cancer incidence or mortality. The remainder returned null findings. The observed association was more consistently seen in studies that investigated the effect of intentional weight loss (5/6 studies) and the risk reduction was greatest for obesity‐related cancers and in women. In conclusion, intentional weight loss does result in a decreased incidence of cancer, particularly female obesity‐related cancers. However, there is a need for further evaluation of sustained intentional weight loss in the obese with less reliance on self‐reported weight data and more focus on male populations.

Erosions after laparoscopic adjustable gastric banding: diagnosis and management

Objective:To define the changing prevalence of erosion after Laparoscopic Adjustable Gastric Banding (LAGB), describing the range of clinical presentations, the approaches to treatment and the outcomes from these approaches over a 15-year study period. Background:A recent systematic review of the literature of erosion after LAGB identified 25 relevant studies and reported a total of 231 erosions in 15,775 patients giving an overall incidence of 1.46%. The review highlighted a broad variation of incidence from 0.2% to 33%. The review was unable to identify either common presentations or an optimal pattern of management. Methods:Patients who underwent a primary LAGB operation between September 1994 and January 2010 by 2 surgeons (P.O.B. and W.B.) were identified in a prospectively maintained database. Those patients who had an erosion of their LAGB were identified. Presentation, operative details, demographics, body mass index, weight history, and perioperative problems were analyzed. Results:In total, 2986 patients were identified. All bands placed were Lap-Bands (Allergan, CA). Hundred erosions were experienced by 85 patients (2.85%) at a median time of 33 months from initial surgery to the erosion (range: 11–170 months). The rate of erosion was highest when the band was placed by the perigastric approach at 6.77%. Since the adoption of the pars flaccida approach, the rate of erosion has dropped to 1.07%. The majority of patients who had experienced an erosion (71 patients; 83.5%) experienced only 1 erosion, 13 patients (15.3%) had 2 erosions, and 1 patient had 3 erosions. The most common presentation was loss of satiety. The band has been successfully replaced in 56 patients. It has been explanted in 27 patients and 2 patients were converted to other bariatric procedures. The weight loss in patients who had a LAGB reinserted after erosion was not significantly different to the background cohort. Conclusions:Erosion of LAGB is uncommon and its clinical course is benign. It is best treated with a staged surgical approach; initially, with removal and repair followed later by replacement. With this approach, weight loss is maintained and reerosion is uncommon.