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B ISSUE 13 | AUGUST 2012 ARIATRIC NEWS pages 18–19 THE NEWSPAPER DEDICATED TO THE TREATMENT OF OBESITY FOR THE HEALTHCARE PROFESSIONAL IN THIS ISSUE... Bypass may increase energy At the Digestive Disorders Federation meeting in Liverpool, UK, Marco Bueter revealed how RYGB may increase energy expenditure potentially culminating in prolonged weight loss 4 ASMBS Bariatric News reports the key highlights from the 29th Annual Meeting 10 Coffee time Pradeep Chowbey, Congress President for IFSO 2012 talks to Bariatric News about his influences, the Dalai Lama and challenges for surgery in India 14 News from the US A study of hospitals has shown that surgical quality varies widely in the US while Allergan has reported a drop in 20 LAGB procedures The future of suture? Undergraduates from Johns Hopkins University have developed FastStitch, a disposable suturing tool to help Patient selection improves banding outcomes Selecting patients according to predictive factors including their initial weight and their willingness to stick to diet and exercise regimes can result in greater weight loss and fewer reoperations following gastric band surgery, according to a study presented at the ASMBS’ 29th annual meeting in San Diego, California. The study, ‘Better weight loss and less reoperation rate following laparoscopic banding in selected obese patients’, validated five factors that the authors had identified in a 2007 study (“Predictive factors of outcome after gastric banding: a nationwide survey on the role of center activity and patients' behaviour”, Ann. Surg.. 2007 246(6):1034-9.) as positively affecting the outcomes of surgery. The patients had a significantly decreased rate of reoperation and reduction in morbidity compared to the historical series identified in their previous study. The study’s lead author was Professor Jean-Marc Chevallier, of Hopital Européen Georges Pompidou, Paris. Results 9% of patients (35) in the study suffered from complications, including 12 slippages, three food intolerances, and 14 port problems. This compares with a complication rate of 19.2% in their historical series, and rates between 33.1% and 50.4% in historical studies published by Mittermair et al (Obes Surg. 2009 19(12):1636-41), Suter et al (Obes Surg. 2006 16(7):829-35) and Van Nieuwenhove et al (Obes Surg. 2011 21(5):582-7). Chevallier noted, however, that these studies were based on long-term historical series involving unselected patients who were not followed up, and who received older gastric bands which are no longer used. 5.1% of patients required abdominal reoperations, compared to 17.2% in the historical series, and 3% had their bands removed, compared to 10.7% in the historical data. Methodology 429 patients were recruited for the study between 2005 and 2011, and were followed for an average of 29.24 months. Selection was based on five predictive factors: n BMI under 50 at time of surgery (mean BMI was 41.60). Jean-Marc Chevallier n Advanced laparoscopic team. n Likely to change eating behaviours. n Likely to practice physical activity. n Age under 40 (average age was 39.7 years). 40 patients dropped out during the study, and the results were based on the remaining cohort of 389 selected patients. Safety and efficacy was based on a historical series of 1227 LAGB patients identified in their 2007 study. Chevallier also found in his 2007 study that a surgical team performing two operations per week or more is likely to have successful outcomes, with higher excess weight loss and fewer complications. Surgery and the redevelopment of eating disorders surgeons by making the closure process simpler and safer 25 Product and Industry news 29 Calendar of events 31 According to a recent presentation at the Digestive Disorders Federation meeting in Liverpool, UK, bariatric surgery procedures could lead to the redevelopment of eating disorders. In her presentation “Eating Disorders and gastric bypass: slipping back?” Dr Denise Thomas, Head of Nutrition and Dietetic Services, Portsmouth Hospitals NHS Trust, UK, said eating disorders such as anorexia nervosa (AN) and bulimia nervosa (BN) have a psychodynamic formulation. Bariatric surgery and eating disorders Thomas discussed the link between bariatric surgery and eating disorders, and explained how surgery influences predisposing (low self-esteem), precipitating (extreme dieting practice) and perpetuating (the biology of semi-starvation) factors, which could cause their redevelopment. Previous research has reported both bulimic episodes and vomiting for weight issues occuring after surgery (de Zwann et al, Surg Obes Relat Dis. 6(1):79-85). Binge eating behaviour is also triggered by extreme dieting. However, the self-induced vomiting seen in BN is not seen post-surgery as vomiting is generally not a purging behaviour and 60% of cases describe vomiting in response to an intolerable food or one that has plugged (the result of overeating particularly bread, pasta and dry meats). “Bariatric surgery leads to Continued on page 3 Denise Thomas Bariatric Surgery Database Software Imagine being able to track all your bariatric surgery cases with ease and recall any record almost instantly… Now you can with just a ‘click’ of a button Dendrite’s innovative software: reveal interpret improve Station Road Henley-on-Thames RG9 1AY United Kingdom Phone: +44 1491 411 288 – e-mail: [email protected] www.e-dendrite.com St Elsewhere’s Hospital NHS Trust AttAch PAtient Sticky here Bariatric operation: Pre-op weight: 109 kg 38.9 kg m-2 Pre-op BMI: Current weight: 76.4 kg 27.2 kg m-2 Current BMI: Total weight loss: Excess weight loss: Vitamins / mineral supplem ents: Regular monitoring (blood test): Clinical evidence of malnutrition: Weight loss and excess 120 P F F F F F F F 32.6 kg 83.9 % Yes Yes No weight loss Excess weight loss F Weight loss F FFF F Weight / kg 100 120 80 100 60 80 40 60 20 40 20 0 0 250 Current comorbidity status Type 2 diabetes: Hypertension: Sleep: Asthma: Functional: Back / leg pain from OA: GORD: PCOS: Menstrual: Apron: Any other information Current progress: Next appointment: Time after surgery / 500 days Impaired glycaemia or impaired glucose tolerance No indication of hyperte nsion No diagnosis or indicatio n of sleep apnoea No diagnosis or indicatio n of asthma Can climb 3 flights of stairs without resting Intermittent symptom s; no medication Intermittent medicat ion No indication / diagnos is; no medication Regular menstrual cycle No symptoms for the notes / GP Satisfactory, as expecte d months NHS Gastric band (on 09 / 04 / 2008) 08 / 07 / 2009 23 / 07 / 1967 Clinic date: Date of birth: % • Creates graphs displaying Excess Weight Loss over time • Links to hospital systems to pre-populate demographic fields • Allows the easy export of data to national/ international registries • Simplifies the data collection process • Maintains patient anonymity and confidentiality (safe and secure) Excess weight loss / • Allows the tracking of procedures and outcomes from all type of bariatric procedures (including bands, balloons, Roux-en-Y, gastric sleeve, duodenal switch and BPD) • Provides detailed tracking of comorbid conditions • Facilitates longitudinal follow-up • Automatically identifies followup breaches • Reduces the workload by automating production of patient reports, operation notes and follow-up letters Unsatisfactory (specify) 750 0 P RP R Primary Revision as a primary Revision S Planned 2 nd stage F Follow up BARIATRIC NEWS 3 ISSUE 13 | AUGUST 2012 Surgery and the redevelopment of eating disorders Continued from 1 significant changes in eating patterns. The main procedures are all primarily restrictive in nature and as such could be suggested to produce a precipitant to eating disorder pathology,” she added. According to the literature, one paper has reported that gastric surgery and restraint from food were the triggering factors of eating disorders in morbidly obese patients (Guisado et al. Int J Eat Disord. 2002 31(1):97-100), however, there have been no recent case reports of AN. Thomas asked the audience to consider those patients who exceed their target weight loss and appear to be in a downward spiral into normal BMI and beyond. “How many of these are now afraid to eat and complain of gut symptoms? We investigate for many gastro intestinal issues, but are these patients displaying anorectic behaviours?” Conditions such as anorexia can be triggered by severe dieting restriction, so in a group of patients undergoing an enforced change from overeating to an extreme restricted diet, this dramatic change in eating habits could be a risk factor in this group of patients (as described in the psycho-dynamic formulation). Chicken or the egg? The question then arises of whether the eating disorders are present before surgery or a new population emerges post-surgery. A population that is adhering to a reduction in portion sizes, is chewing thoroughly, eating slowly and feels the need to induce vomiting to relieve sensations/pains, these are all permitted behaviours that resemble eating disorder pathology. These conditions therefore “find a home” more readily in some patient’s psyches following surgery. BED Binge eating disorder (BED) is the most common eating disorder reported in patients prior to bariatric surgery, ranging from 10%–50% (Ashton et al urg Obes Relat Dis. 7(3):315-20) and 27% (Lilenfield et al Compr Psychiatry. 49(3):247-54) of patients present with a lifetime history of the disorder. The Diagnostic and Statistical Manual of Mental Disorders (DSM) defines BED as the consumption of a larger than normal amount of food, taken over a discrete period of time, accompanied by a subjective loss of control. This is followed by an association of guilt, shame, eating rapidly and having physical discomfort when eating. According to Thomas, it was this definition that caused many surgical teams to deny patients exhibiting BED surgery, as it was felt the overeating would be incompatible with the restrictive nature of the surgery. However, one study has shown dramatic decreases in binge eating due to the restrictive nature of the procedure, with a reduction from 48% to 0% of the cohort (Latner et al Obes. Res. 2004 12(6):956-61). For patients with BED, one major issue is the return to eating larger volumes of food often within six months of surgery as this triggers feelings of guilt and shame, and of letting the surgical team down. “It is easy to see how post-surgery patients may well exhibit some of the traits more commonly seen within BED. Although these patients appear to lose less weight than those who were previously non-binge eaters, weight loss post-surgery results are significant.” Disordered eating cycle Understanding the vulnerability of patients is an important aspect of their pre- and post-surgical care. In this respect, Thomas said it is vital to recognise the disordered eating cycle, a continuing sequence of stages patients undergo (Figure 1). Disordered eating cycles, whether bulimic or binge eating, have a pattern based on restriction of eating. Patients focus on the negative (rules too hard, denial of foods), leading the need to over-eat/crave, which triggers the feeling of failure, in turn increasing the negative feelings and the cycle begins again. “Obese individuals who have been susceptible to this pattern of Negative feelings/ low self esteem Restriction/ Control of eating Failure Loss of control/ ‘overeating’/ craving Rules too hard Figure 1: Disordered eating cycle behaviour are therefore exposed to these issues post-surgery. There is a vulnerability which must be recognised, understood and treated,” explained Thomas. Types of binge eating According to Latner and Clyne (Int J Eat Disord. 2008 41(1):1-14) there are two types of binge eating, objective and subjective. Objective binge eating is the consumption of a large amount of food with a loss of control, whereas subjective binge eating is the consumption of a moderate amount (perceived as larger than normal) with loss of control. This suggests that it is the loss of control that is crucial. “Subjective binge eating seems to possibly fit the pattern of the bariatric patient post-surgery and it is the loss of control that is clinically significant, rather than the amount of food eaten,” she said. “This resonates with the experience in my practice, where patients compare the volume of food they eat. The patients who perceive that they are eating too much feel guilt and shame, “I have let you down” being a common phrase. They believed that they would never eat this way again and feel distraught, although the binge is still Subscribe to Bariatric News A subscription to Bariatric News is free and you can receive a printed copy delivered to your home, hospital or company and/or electronic copy delivered via email. Please send an email to [email protected] stating your full postal address (for a printed copy). Alternatively, please visit our website and complete the online subscription form. Subscribe online@ www.bariatricnews.net 2012 Copyright ©: Dendrite Clinical Systems Ltd. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, transmitted in any form or by any other means, electronic, mechanical, photocopying, recording or otherwise without prior permission in writing of the Managing Editor. The views, comments and opinions expressed within are not necessarily those of Dendrite Clinical Systems or the Editorial Board. considerably less than it was before surgery. They feel out of control”. Grazing Thomas then asked whether bariatric surgery triggers a switch from binge eating to a higher proportion of grazing behaviour in these patients. Grazing is defined by the consumption of a smaller amount of food taken continuously over a longer period of time, eating more than the subjects consider normal. One study in particular examined the relationship between pre-operative and post-operative eating behaviour and weight loss outcome, and found that food volume decreased but extended eating periods increased from 26% to 38% of patients post-surgery(Colles et al, Obesity 2008 16(3):615-22). It appears as though pre-operative binge eaters became grazers, which was associated with poorer weight loss and higher psychological distress, tipping patient back into the negative cycle of disordered eating again. They concluded that uncontrolled eating (higher energy intake with higher percentage fat, with less dietary restraint and more hunger) and grazing were identified as two high-risk eating patterns post-surgery. “Initially there is a great euphoria post RYGB because of the dramatic weight loss and a feeling of being in control for once, but that quickly changes with a return of “appetite” as they perceive it,” said Thomas. “The ability to eat “more” is taken as “I must be hungry, because I am eating and able to eat” independent of the effect of gut hormones.” Surgery means patients are placed back into the cycle of having to make decisions about volume and choices of foods. This becomes part of the non-core elements of psychopathology of the eating disorder. The pre-occupation with food and rituals that the surgery itself causes, which prior to surgery had been due to needing to exert control, now it has to be considered to ensure that food can be eaten and tolerated. “Gastric by-pass surgery therefore alters eating behaviour but not the triggers to motivate the patient to binge eat,” she added. Conflicting issues The evidence points to patients having conflicting issues. Their behaviour has a history of binge eating, but following surgery this affects the patient’s eating habits with RYGB reducing circulating ghrelin levels and increasing GLP-1 & PYY. However, for some patients this does not appear to provide a feeling of satisfaction long term and hence they switch into a pattern of grazing behaviour. Previous binge eaters are more likely to continue with this eating pathology or switch to grazing. The surgical effect on eating behaviour might also trigger a negative effect as it makes individuals who were super sensitive to food choices, thinking about food continually, all the more encouraged to do so. Thomas said it is the likely interaction with the environment (psychosocial issues, learned behaviour etc) that is the very powerful influence on patients. Those who respond to such triggers may not be aided as much by weight loss surgery, because these psychosocial cues are not altered and remain constant in their lives. Conclusions Thomas said that cognitive behaviour therapy before surgery on disordered eating/binge eating appears beneficial and Ashton et al (Surg Obes Relat Dis. undefined 7(3):315-20.) have shown that outcomes post-surgery can improve (46% vs. 38% EBWL at six months; 59% vs. 50% at one year). 4 BARIATRIC NEWS ISSUE 13 | AUGUST 2012 What to do when the sleeve fails? Safe, effective and durable are words often associated with laparoscopic sleeve gastrectomy. However, when the procedure does fail, what can a surgeon do to rectify the situation? According to Professor Andrés Sánchez-Pernaute, Hospital Clínico San Carlos, in Madrid, Spain, there are several options available for both obese and super-obese patients which result in adequate excess weight loss. The Hospital Clínico San Carlos, in Madrid, Spain, currently performs approximately 150 bariatric procedures annually. The most common procedure is gastric bypass (around 60 cases per year), followed by biliopancreatic diversion with duodenal switch and sleeve gastrectomy (around 45 cases per year). “Our indications for sleeve whether to perform a two-stage or stand-alone procedure are dependent on several factors including BMI, co-morbidities, age, weight loss, as well as considering medical or surgical considerations,” said Sánchez-Pernaute. “Approximately 50% of cases are stand-alone and 45% the first step of a two stage procedure. The remaining 5% cases are ‘run away’ cases, that is, cases in which intraoperative problems or findings indicate the performance of a sleeve gastrectomy.” Failure In regard to patient outcomes, the different results are explained by the heterogeneous population receiving treatment. For example, the re-operation rates for stand-alone procedures are 5%, compared with 27% for two-stage procedure. “Operating on different patients and getting different results because of different failures, means we need to be able to offer different solutions,” SánchezPernaute. In his own institution, SánchezPernaute explained that the key factors influencing weight loss is whether a patient’s BMI is over or under 50 and whether they are older or younger than 40. Ten percent of sleeve patients fail who are under 40 years of age and have a BMI under 50. However, 40% of sleeve patients fail if they are aged over 40 with a BMI over 50. “The results show patients aged over 40 with a BMI over 50 could not be most appropriate population and the sleeve could be an insufficient operation. Therefore, we need to find another solution.” Solutions Sánchez-Pernaute said that as 36% of gastric bypass patients with a BMI over 50 fail to reach a 50% excess weight loss Andrés beyond five years, Sánchez-Pernaute it is questionable to convert a failed sleeve into another procedure that is going to offer the same rate of failures as the sleeve. He questioned whether converting a failed sleeve into a gastric bypass is really an improvement over a re-sleeve or a plication. Therefore, after sleeve failure in a patient with a BMI over 50, the procedure of choice is a malabsorptive procedure, such as the single-anastomosis (one loop) duodeno-ileal bypass with sleeve gastrectomy (SADI-S). The procedure has previously obtained good results (Sánchez-Pernaute ey al, Obes Surg. 2010 20(12):1720-6); however, would a one-loop DS (SADI) work similarly as a second step after a sleeve in a patient with an initial BMI over 50? To answer the question, SánchezPernaute and colleagues established a prospective, randomised clinical trial in which patients with BMI over 50 received initially a sleeve gastrectomy as a first step. If the patient’s weight stabilised or if they regained weight, they were randomised to receive a standard Roux-en-Y duodenal switch or SADI. The patient characteristics are shown in Table 1. There were no intraoperative or postoperative complications in any of the groups With regards to excess weight loss (%), no significant differences were observed between both groups. Excess weight loss (%) is shown in Table 3. Time DS SADI p Table 1: Patient characteristics 3 months 54 52 0.8 Gender 8 male, 9 female 6 months 66 62 0.6 Age 40 ys (20 – 68) 9 months 74 67 0.4 Initial weight 165 kg (128 – 216) 12 months 82 74 0.3 Initial BMI 60.2 kg/m2 (53.4 – 76.1) 18 months 85 77 0.3 T2DM 4/17 (23.5%) 24 months 80 71 0.4 HTA 11/17 (65%) % of WL 52 52.6 At a mean follow-up of 18 months, the results of the sleeve showed a mean weight of 122kg (94-183) and a mean BMI of 44 (36-54). The outcomes following standard Roux-en-Y duodenal switch or SADI are shown in Table 2. Table 2: Patient characteristics at the second step DS SADI p Initial BMI 57 63 0.04 Min. BMI Sleeve 41 48 0.01 % pts > 50% EWL 50% 28% 0.3 % pts BMI > 40 14% 62% 0.05 Mean op time 230m 138m 0.007 Table 3: Excess weight loss (%) Conclusion In conclusion, he said that biliopancreatic diversion is an adequate operation in the super-morbid patient after a failed sleeve gastrectomy, and a singleanastomosis duodeno-ileal bypass is at least as effective as standard Roux-enY duodenal switch as a second step in the super-morbid patient. “When the sleeve fails in the younger and less heavy patients, we suggest to re-sleeve or plicate, but for the heavier patient, divert the duodenum in one loop.” Gastric bypass may increase energy expenditure Rat studies suggest increased total energy expenditure contributing to weight loss after Roux-en-Y Gastric Bypass (RYGB) surgery ture, and other explanations such as malabsorption and inflammation were excluded. “This suggests that inflammation or infections are unlikely to be causes of increased energy expenditure after RYGB”, Bueter said. “These results are somewhat paradoxical, as eating less and losing body weight usually leads to a down-regulation of energy expenditure as a physiological compensatory mechanism to oppose weight loss.” Bueter therefore proposed three physiological mechanisms that could potentially explain the findings including alterations in diet-induced thermogenesis, increased gut hypertrophy and increased activation of brown adipose tissue (BAT). p=0.001 4.5 4.0 3.5 kcal/kg/hr Potential mechanisms include gut hypertrophy, activation of brown adipose tissue and increased levels of gut hormones p=0.05 p=0.05 3.0 2.5 2.0 1.5 1.0 0.5 So far, the mechanisms underlying weight loss maintenance following RYGB have not been extensively studied. However, a recent presentation at the Digestive Disorders Federation meeting in Liverpool, UK, provided some unique insights into potentially underlying physiological mechanisms and concluded that RYGB may increase energy expenditure potentially culminating in prolonged weight loss. In his talk, “Changes in energy expenditure after gastric bypass,” Dr Marco Bueter, Department of Surgery, University Hospital Zurich, Switzerland, presented results of experimental and human studies aiming to investigate physiological mechanisms behind the superiority of RYGB in inducing longterm body weight loss. “Gastric bypass surgery in rats has been proven to be a valid model of human metabolic surgery.” Therefore, Bueter and his colleagues developed and established a RYGB rat model to further examine underlying mechanisms. In his presentation, Bueter showed body weight data of three experimental groups of rats: a RYGB group, a sham-operated group with unlimited access to food (ad libitum fed) and a sham-operated group that only received as much food as necessary to maintain a similar body weight as the RYGB rats (body weight-matched (BW)). While RYGB rats lost approximately 15-20% of their body weight within ten days after surgery and then maintained their low body weight at a stable level, shamoperated rats initially lost some weight (potentially due to the surgical trauma) and then gained weight throughout the rest of the observation period. In addition, Bueter and his colleagues observed that the BW group of sham-operated rats required only about 60% of food that was consumed by the RYGB rats (Gastroenterology. 2010 May;138(5):1845-53). “This finding indicates that the body weight loss 0 Sham (n=7) BW matched (n=7) Gastric bypass (n=14) Figure 1: 24 hour energy expenditure after RYGB is not completely due to decreased food intake alone and it raises the possibility of enhanced energy expenditure following RYGB,” said Bueter. Therefore, the researchers measured 24-hour energy expenditure using metabolic chambers allowing to determine oxygen consumption and CO2 production over a longer period of time. The metabolic chambers further enabled Bueter to investigate differences in physical activity between the groups by measuring the number of interruptions of infrared sensors on both sides of the cage. As shown in figure 1, the researchers found RYGB rats to have higher total energy expenditure in comparison to ad libitum fed and body-weightmatched sham-operated control rats. Furthermore, the increased energy expenditure did not correlate with differences in activity and/or body temperaSham jejunum Diet induced thermogenesis “In a simplified way, diet-induced thermogenesis can be considered as increase in the metabolism after a meal ingestion”, said Bueter. He further reported that “RYGB rats showed a greater cumulative increase in total energy expenditure after a 5-g test meal compared with the control groups.” This suggests that differences in diet-induced thermogenesis may have a role in higher total energy expenditure after RYGB surgery. Gut hypertrophy At necropsy, the researchers noted a difference in the macroscopic appearance of the small gut between sham-operated and RYGB rats, with the small bowel of RYGB rats appearing thicker and stronger. Histological analysis showed a significantly greater mucosa height as well as a significantly thicker muscle layer of the small bowel after RYGB compared to the small intestine of sham-operated rats (Figure 2). Furthermore, there was a 72% increase of total small bowel weight following RYGB. RYGB alimentary limb 500µm 500µm Figure 2: Histological image of alimentary limb mucosa of a RYGB rat in comparison with the corresponding segment of the jejunum of a sham-operated rat. Marco Bueter “The small intestine is metabolically very active and gut hypertrophy may hence explain a higher energy requirement that contributes to body weight loss”, Bueter concluded. Brown adipose tissue As brown adipose tissue (BAT) activity is negatively correlated with the body mass index in humans, it has been suggested that BAT may have an important role in promoting weight loss. Bueter and his colleagues therefore investigated whether RYGB induces a higher activity of BAT in their rodent model. “We found that there was no difference in BAT activity after RYGB compared to sham-operated controls. Thus, RYGB surgery does not increase the activity of brown adipose tissue in rats suggesting that other mechanisms are involved to explain the increased energy expenditure after RYGB surgery”, Bueter said. Conclusion “The available experimental and clinical data indicate that RYGB surgery functions by altering the physiology of body weight regulation, at least partly by increasing energy expenditure and diet-induced thermogenesis,” Bueter concluded. “Potential mechanisms include an increased diet induced thermogenesis, hypertrophy of the small intestine, but most likely not an increased BAT activity. Our study provides additional support for further investigations of the underlying mechanisms of RYGB surgery to identify novel therapies for obesity and related metabolic diseases.” 6 BARIATRIC NEWS ISSUE 13 | AUGUST 2012 The Ring: to have, or not to have? Study The aim of the retrospective study was to evaluate whether BRYGB procedures resulted in better postoperative weight loss and significantly improved long-term weight loss compared with RYGB. Between 2007 and 2011, 236 patients in the banded group had a conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring (The GaBP Ring, Figure 1) and 349 in the nonbanded group had a conventional laparoscopic Roux-en-Y gastric bypass alone. All the patients were operated in three Bariatric Centres of Excellence in Sint Niklaas (Belgium) under Luc Lemmens’ ledership, in Freiburg by Konrad Karcz and in Jeddah (Saudi Arabia) under Waleed Bukhari’s leadership. The primary outcome was post-operative reduction of BMI and excess weight loss (EWL, %) at three-, six- and 12 months, two, three and four years. Baseline patient demographics between the banded and non-banded groups respectively were similar in terms of mean weight (122kg vs. 115kg), mean BMI (42 vs. 41) and mean excess weight (62kg vs. 57kg). T2DM recurrence mainly influenced by diabetic history A new study presented at The Endocrine Society’s 94th Annual Meeting in Houston, TX, has claimed that T2DM recurrence following bariatric surgery is mainly influenced by a longstanding history of the condition prior to surgery. The research was presented by the study’s lead author, Dr Yessica Ramos, an internal medicine resident at Mayo Clinic Arizona in Scottsdale. Ramos and colleagues studied the medical records of 72 obese patients with Type 2 diabetes who underwent a Rouxen-Y gastric bypass operation between 2000 and 2007 and had at least three years of follow-up visits. Of these, 66 patients (92%) had a reversal of their diabetes at some point. However, within three to five years after surgery, 14 (21%) of the 66 patients experienced a recurrence of their type 2 diabetes (documented by bloodwork or restarting use of diabetes medications). The patients who did not have recurrence of diabetes lost more weight initially and maintained a lower mean weight throughout the five years of follow-up, although both groups regained similar amounts of weight. There was no significant association between higher recurrence rate and body mass index before surgery, the authors found. They did find that the longer the duration of type 2 diabetes before surgery, the higher the probability of diabetes recurrence. Study patients with more than a five-year duration of type 2 diabetes before they had bariatric surgery were 3.8 times more likely to have recurrence of type 2 diabetes compared to patients with less than a five-year history of diabetes. “The recurrence rate was mainly influenced by a longstanding history of Type 2 diabetes before the surgery,” said Ramos. “This suggests that early surgical intervention in the obese, diabetic population will improve the durability of remission of Type 2 diabetes. Providers and patients need to be aware of this information, to have a better idea of the expected outcome and be able to make an informed decision about pursuing gastric bypass surgery. 100 * 75 % EWL (mean) One of the current controversies in bariatric surgery is whether to utilise a ring or ‘band’ during bypass surgery. At the recent IFSOEuropean Chapter meeting in Barcelona, a three-centre retrospective study comparing banded bypass (BRYGB) to conventional non-banded bypass (RYGB) was presented with four year outcomes. The study initiator PD Dr Konrad Karcz, University of Freiburg, Germany, was inspirited by talks with MAL Fobi who encouraged him to perform this study. “Writing in the journal Obesity Surgery in 1994, the father of the Roux-en-Y gastric Bypass, Dr Edward Mason, wrote ‘Roux-en-Y Gastric Bypass is primarily a restriction operation, just as with VBG, it is important that the outlet of the pouch does not stretch’”, began Karcz. “This loss of the restrictive component of the operation was confirmed by increased caloric intake in some patients.” The Silastic Ring Gastric Bypass (SRGBP) was introduced by Mal Fobi in 1989, in an effort to enhance the restrictive mechanism of the Roux-en-Y gastric bypass by controlling the stoma size and reducing the reservoir capacity after the gastric bypass. Stretching of the outlet combines the pouch and the dilated proximal jejunum into a big reservoir. Over the years, numerous materials and implants have been used to ‘band’ the bypass including marlex mesh, porcine graft, bovine graft, Ethibond suture the LapBand and mostly the GaBP Ring. “However, opinion is divided as to whether BRYGB or RYGB produces the better long-term results,” he added. “Therefore, we decided to retrospectively examine the results from three centres.” * 50 Conv Banded * p<0.05 25 0 3 months 6 months 1 year 2 years 3 years 4 years Figure 2: Post-operative data mean EWL (%) Figure 1: Implanted GaBP Ring The outcomes for BMI at four year show that patients in the conventional group had a lower mean BMI than the banded patients from the date of the operation to two years. However at three years, the mean BMI was the same in both groups and at four years the mean BMI was lower in the banded group (Table 1). Table 1: Post-operative data mean BMI Day1 3mo 6mo 1y 2y 3y 4y BRYGB 43 34 31 28 27 26 25 RYGB 41 33 29 27 26 26 27 The authors reported a similar pattern when examining the postoperative mean EWL (%) with a benefit in conventional group out to six months but with the benefit then shifting to the banded group out to four years (Figure 2 and Table 2). Both these outcomes are particularly important as the baseline mean weight (122kg vs. 115kg), mean BMI (42 vs. 41) and mean excess weight (62kg vs. 57kg) were higher in the banded group. Table 2: Post-operative data mean EWL (%) 3mo 6mo 1y 2y 3y 4y BRYGB 40% 58% 73% 77% 79% 85% RYGB 40% 60% 72% 74% 72% 69% Complications The authors also examined ring-related complications and noted three patients where the Ring was open two years after operation, leading to wait gain. There were no erosions reported in this series. However, Stubbs et al (Obes Surg. 2006 16(10):1298-303) and Fobi et al (Obes Surg. 2001 11(6):699-707), have reported instances of band erosion (rate of 1.63%, 48 of 2,949 patients) or migration into the gastric lumen after banded gastric bypass, although the erosion incidence was lower (0.92%) in primary operations. Removal of the ring is combined with significant weight gain occurring in 43.75% patients who underwent ring removal, with an average of 14% EWL regained (Fobi et al. 2011 IFSO Congress and Barroso et al. 2007 IFSO Congress). Conclusion The data suggests that banding the bypass leads to better weight loss after four years and helps reduce the weight regain, which may be due to prevention of pouch-outlet dilation, the authors concluded. In addition, the GaBP-Ring is a standardized device which is easy to remove in case of complications. GABY study The two years results of the multicentre, prospective, randomized Banded versus conventional laparoscopic roux-en-y study, designed to compare banded and non-band laparoscopic Roux-en-Y gastric bypass, will be presented at the IFSO World Congress in New Delhi, India, in September 2012. “Banding the sleeve gastrectomy just makes sense” Dr Mal Fobi, a world-renowned bariatric surgeon and past president of the International Federation for the Society of Obesity and Metabolic Surgery (IFSO) in a presentation at a surgeons’ workshop in Sint Nicklaas, Belgium stated, “It just makes sense to band the sleeve gastrectomy operation, just as the gastroplasty operations were banded and as the gastric bypass operation is banded to enhance the restrictive mechanism of the operation”. The sleeve gastrectomy is being used more frequently as more and more surgeons are switching from gastric banding.(Bariatric ENews July, 2011) The currently understood mechanism responsible for the sleeve gastrectomy operation are: 1.The ghrelin effect (resecting the parietal mass that produce ghrelin resulting in anorexia), 2.The restrictive effect (creation of a small tubular stomach pouch that decreases the caloric intake) and 3.The rapid transit effect (rapid transit of food from the small sleeve gastrectomy stomach into the small bowel thus releasing incretins from the small bowel that inhibit caloric intake). It has been reported that in the initial year after the sleeve gastrectomy the weight loss is more rapid than seen with the gastric bypass and the total weight loss approaches that reported after the gastric bypass operation.(Sleeve Gastrectomy Summit, OOBSJ, 2012) “We do not have to reinvent the wheel”, Dr Fobi continued. “30–50% of patients with a sleeve gastrectomy will have progressive weight regain because of the dilation of the sleeve pouch thus minimising the restrictive component of the operation and thus requiring Mal Fobi revision surgery which may be either re-sleeving or conversion of the sleeve gastrectomy to either a gastric bypass or BPD with a switch.” In an effort to address this loss in the restrictive mechanism of the sleeve gastrectomy, as more and more surgeons use the sleeve gastrectomy as a stand alone operation, there has been the trend towards a very narrow sleeve resulting in a significant leak rate (intractable leaks), strictures and reflux. Banding the sleeve gastrectomy enhances the restrictive mechanism just like banding the gastroplasty operations and gastric bypass operation. Surgeons banding the sleeve gastrectomy with a GaBP ring have documented control of the reservoir capacity of the sleeve and prolongation of the weight loss maintenance (Karcz, SOARD 2010). Bariatec Corporation, the maker of the GaBP ring for banding the gastric bypass, the sleeve gastrectomy and other gastroplasty operations is carrying out a multi-centre international prospective clinical trial to substantiate the benefit of banding the sleeve. “Until prospective clinical trials with long term results are performed and reported,” Dr Fobi advised, “It just makes sense to band the sleeve gastrectomy operation”. 8 BARIATRIC NEWS ISSUE 13 | AUGUST 2012 Studies show new bariatric implant is “safe and effective” A novel bariatric implant and its delivery system have successfully completed both a proof-of-concept study and a pivotal study, indicating that it can feasibly be safely and effectively used in adult patients. The Prevail Implant System, designed by California-based start-up Vibrynt, is intended to fill the space that the stomach normally expands into, thereby limiting the patient’s food consumption. Both studies were presented at the ASMBS’ 29th Annual Meeting in San Diego. The multi-centre, single-arm proofof-concept study was designed to evaluate feasibility and safety in the device, and included six subjects aged 18-60 years with a BMI between 35 and 55. Sixty-nine subjects were evaluated in the pivotal study, which examined safety through adverse events and effectiveness based on excess weight loss. The mean excess weight loss among patients installed with the device was 28.3% ± 14.45% at six months. Feasibility was based on placement success, and safety was based on severe adverse events. In the pivotal study, the device was successfully implanted on the first attempt in 94.2% of patients. Severe device-related adverse events in more than one pivotal study subject included abdominal and upper abdominal pain, and medical device removal. The investigators concluded from the studies that the use of the adjustable, reversible implant in adult subjects appeared “safe and well-tolerated”. Installation Vibrynt, and its Prevail system, was formed in California in 2006, in the Exploramed medical device incubator. The device is currently at an investigative stage, to establish whether the patient’s calorific intake can be restricted by filling the space the stomach would normally expand into, thereby inducing early satiety. After the ideal location for the device is established using a template tool, the Prevail implant is inserted laparoscopically through a single incision, within the ribcage and next to the stomach. It is then filled with sterile saline. Once the device is inflated, the insertion tool can suture the device in place. An adjustment port, similar to that seen with an adjustable laparoscopic gastric band, is placed at the incision, which can be used to alter the amount of restriction that the device places on the stomach. The Prevail System does not require any altering of the gastrointestinal anatomy, and does not place any restrictions on the types of healthy foods the patient can eat. Future The system is being evaluated in an FDA-approved research study to support a premarketing application to the FDA. The purpose of the study is to determine the safety and effectiveness of the system for the treatment of morbid obesity. It will compare the results attained by patients using the Prevail system to those attained using an adjustable gastric band. Study enrolment is currently scheduled to take place from August 2012 to August 2013. Patients considered for the study will have a BMI between 40 and 50, or between 35 and 40 with one or more comorbidity; be aged 18–65; have a five-year history of morbid obesity; and will demonstrate a documented failure with non-surgical weight-reduction options like diets, exercise and behaviour modification programmes. ‘Promising’ SAMSEN system performs endoscopic GI bypass Using self-assembling magnets to perform an endoscopic gastrointestinal bypass is safe, can be performed in less than 30 minutes and can be conducted using only local anaesthetic, according to a study presented at the Digestive Disease Week conference in San Diego. “These findings suggest we may be close to performing a surgical-quality gastrointestinal tract bypass using an incisionless platform, which is less invasive and potentially safer than the surgical alternative,” said clinical study lead Dr Marvin Ryou, from Brigham and Women's Hospital in Boston, MA, who presented the threemonth outcomes. The procedures were performed on five pigs. An endoscope was advanced into the peritoneal cavity of five pigs through the gastrotomy, and a segment of the small bowel was grasped and pulled closer to the stomach. An enterotomy was created, and a custom overtube was advanced into the small bowel for deployment the SAMSEN (SelfAssembling Magnets for Endoscopy) system. A reciprocal magnetic assembly was then deployed in the stomach and the two magnetic systems were connected under fluoroscopic and endoscopic guidance (See illustration). After initial mating of the magnets, the compressed tissue between the two magnets would die off over several days while tissue remodeling would occur around the points of magnet compression. Eventually, a tunnel would form connecting the stomach and the small intestine. The researchers assessed gastrojejunostomy leaks by contrast. The pigs were scoped every three to six days until creation of an anastomosis. The completely joined Figure 1: Two magnetic systems are connected magnets would be naturally expelled, leaving behind a clean anastomosis without any foreign material. “The anastomosis was created by magnetic compression, a process that takes advantage of the body’s natural healing process to remodel the GI tract,” said Ryou. Investigators performed necropsies on all pigs after three months and found that the bypasses remained large and completely open, which had not been previously demonstrated by this technology. Weight trends plateaued in the bypass pigs while age-matched, litter-matched controls doubled their weight. Furthermore, no adhesions were found, which the researchers said represents a “significant departure” from conventional surgery, and would likely make any subsequent surgical procedures less complicated. The absence of adhesions could represent a significant step forward for abdominal surgery. Previous studies attempting this kind of procedure used small, solid magnets, which limited the size of the bypass and naturally closed up after a few weeks. Larger magnets could not be delivered endoscopically due to anatomical restrictions. “That is why we developed the concept of these smart magnets that can self-assemble into larger structures within the GI tract, which in turn, create larger and more durable bypasses,” added Ryou. He claimed that the findings are also important because they suggest other potential advantages over surgical bypass. For example, an effective endoscopic method of bypass creation is inherently less invasive because it avoids abdominal incisions of conventional surgery. Ryou cautioned that these results, while promising, are from a small animal study, but he added investigators are very close to commencing human work in this area. The researchers said that there are several potential applications for this technology, including weight loss, treatment of type 2 diabetes and palliation of an obstructing cancer. This study was funded by the US Department of Defense and Beacon Endoscopic, the developers of the SAMSEN system. Normal weight diabetics have higher mortality than overweight counterparts Patients who are normal weight at the time of a diagnosis of diabetes experienced higher rates of total and non-cardiovascular death, compared with those who were overweight or obese at diabetes diagnosis, according to a study in the Journal of the American Medical Association. “Type 2 diabetes in normal-weight adults is an understudied representation of the metabolically obese normal-weight phenotype that has become increasingly common over time,” the authors stated in the paper. “It is not known whether the ‘obesity paradox’ that has been observed in chronic diseases such as heart failure, chronic kidney disease, and hypertension extends to adults who are normal weight at the time of incident diabetes.” Dr Mercedes R Carnethon, Feinberg School of Medicine, Northwestern University, Chicago, and colleagues conducted a study to compare mortality between participants who were normal weight and overweight or obese at the time of new adult-onset diabetes. The study consisted of a pooled analysis of five longitudinal studies with a total of 2,625 participants with new diabetes. Included were men and women (older than 40 years of age) who developed incident diabetes based on fasting glucose 126mg/dL or greater or newly initiated diabetes medication and who had concurrent measurements of BMI. Participants were classified as normal weight (BMI 18.5 to 24.99) or overweight/obese (BMI>25). Fifty percent of the participants were women and 36% were non-white. The proportion of adults who were normal weight at the time of incident diabetes ranged from 9% to 21% (overall 12%). During follow-up, 449 participants died: 178 (6.8%) from cardiovascular causes and 253 (10.4%) from non-cardiovascular causes. Eighteen causes of death were unidentified. In the pooled sample, total mortality and cardiovascular and non-cardiovascular mortality were higher in normal-weight participants, compared with rates among overweight or obese participants (284.8, 99.8, and 198.1 per 10,000 person-years, respectively, vs. 152.1, 67.8, and 87.9 per 10,000 person-years, respectively). After adjustment for demographic characteristics and blood pressure, lipid levels, waist circumference, and smoking status, hazard ratios comparing normal-weight participants with overweight/obese participants for total, cardiovascular, and non-cardiovascular mortality were 2.08 (95% CI, 1.52-2.85), 1.52 (95% CI, 0.892.58), and 2.32 (95% CI, 1.55-3.48), respectively. “These findings are relevant to segments of the US population, including older adults and nonwhite persons who are more likely to experience normal-weight diabetes,” the authors noted. The researchers write that mechanisms to explain their findings are unknown, but could indicate a genetic predisposition: “Previous research suggests that normal-weight persons with diabetes have a different genetic profile than overweight or obese persons with diabetes. If those same genetic variants that predispose to diabetes are associated with other illnesses, these individuals may be ‘genetically loaded’ toward experiencing higher mortality.” The researchers add that future research in normal-weight persons with diabetes should test these genetic hypotheses, along with other plausible mechanisms to account for higher mortality, including inflammation, the distribution and action of adipose tissue, atherosclerosis burden and the composition of fatty plaques, and pancreatic betacell function. Editorial In an accompanying editorial, Dr Hermes Florez, University of Miami Miller School of Medicine, and Miami Veterans Affairs Healthcare System, noted that the study addresses an emerging challenge regarding diabetes and weight status. “This could be a wake-up call for timely prevention and management to reduce adverse outcomes in all patients with type 2 diabetes, particularly in those metabolically obese normalweight at diagnosis, who may have a false sense of protection because they are not overweight or obese,” the editorial stated. “Standards of diabetes care recommend weight loss for all overweight or obese individuals who have diabetes. Low carbohydrate, low-fat, calorie-restricted, or Mediterranean diets may be effective weight-loss strategies in these individuals.” Hermes adds that the additional benefits of increased physical activity and behaviour modification strategies may lead to the successful implementation of weight management and healthy living programs for all patients with diabetes. “It is important to understand how diabetes duration relates to the benefits of intentional weight loss, as well as the clinical consequence associated with sarcopenic obesity and bone loss in older adults with or at high risk for diabetes.” The research was funded by a National Institute of Diabetes and Digestive and Kidney Disease grant. BARIATRIC NEWS 9 ISSUE 13 | AUGUST 2012 Do it right the first time: Banded bypass reduces long-term weight regain I t is clear by now that after five years the standard Roux en Y Bypass is faced with a considerable amount of re-operations due to weight regain. This can mount up to 30 to even 50% of the initial patients requiring revisional surgery. Main reason for the weight regain is the dilatation of the gastric pouch, eventually accompanied by dilatation of the anastomosis and/or small bowel. “Although patients lose weight and can be no longer considered obese, some are still psychologically obese and after a year because they can eat more they enter old eating habits,” said Professor Volker Lange, director of adipostas surgery, Vivantes Hospital, Berlin-Spandau, Germany. “The overeating can cause pouch dilatation and subsequent weight gain.” This can be avoided by placing a gastric ring on the gastric pouch 1-2cm proximally of the anastomosis, therewith creating a neo pyloris that induces an initial barrier to overeating. More importantly, it protects the anastomosis from overstretching. This helps the patients a lot in changing their eating habits, as they experience a stronger and longer-lasting feeling of satiety. “We use the MiniMizer Ring from Bariatric Solutions which has two major benefits in our view: the ring is equipped with a blunt, silicone covered introducer needle that helps us place the ring without having to dissect posterior to the gastric pouch,” said Lange. “We only need to dissect a small opening in the serosa and the introducer places the ring easily. The ring also has four closing positions and thereforev four different diameters, like a mini tie wrap. Although the pouches can be calibrated with a 36French calibration tube, the thickness of the stomach wall can still vary and the MiniMizer Ring offers the flexibility to close the Volker Lange ring at any desired diameter to match the size of the pouch at hand. It also allows for re-opening if the ring is either too tight or too loose. The material is soft, yet firm and the literature has shown that rings of this size and elasticity have only between 1-2% of erosion, which oftentimes passed via naturalis. Lange added that the banded bypass is still a very new procedure and although there are no published data from any randomised clinical trials, Konrad Karcz will shortly published the outcomes from a trial comparing banded and nonband laparoscopic Roux-en-Y gastric bypass. “A recent publication by Awad1, who compared banded vs. non-banded bypass over a period of ten years, supports our choice for the banded bypass. We feel the procedure is the way to go and have made a standard part of the therapeutic portfolio“ 1 William Awad & Alvaro Garay & Cristián Martínez: Ten Years Experience of Banded Gastric Bypass: Does It Make a Difference? Obes Surg (2012) 22:271–278 10 BARIATRIC NEWS ISSUE 13 | AUGUST 2012 ASMBS 29th Annual Meeting – News in Brief 29th Annual Meeting June 17–22 2012 Total vertical gastric plication: positive experience Dr Ariel Ortiz reported positive initial findings from a series of 454 total vertical gastric plication operations performed between July 2010 and October 2011. Of the 454 patients, 429 were having their initial surgery and 25 were receiving revisions from gastric band surgery. The mean surgery time was 42 minutes. There were no fatalities, and a 4.3% total complication rate. Ortiz noted that while his initial experience was positive, long-term data on the operation was still not available. Survey reveals malpractice suit extent and cost American bariatric surgeons receive on average 1.5 lawsuits during their career, according to a survey of ASMBS members. Out of 329 surgeons who responded to the survey, 464 lawsuits were reported from 156 responses. 48% of surgeons had never had a bariatric-related lawsuit filed against them. The average amount paid was $622,000. Dr Ramsey Dallal et al found that the probability of a surgeon experiencing a lawsuit was independently associated with the years in practice and number of total cases the surgeon has performed. Greater curvature plication appears safe and effective Laparoscopic greater curvature plication, an emerging bariatric technique, appears to be relatively safe and effective for morbidly obese patients, according to a new study by Dr Stacy Brethauer et al. After one year, in 32 patients, the mean overall percentage excess weight loss was 40% ± 24.2%. The most common post-operative complicatiosn were nausea (25), abdominal pain (17), and vomiting (7). Brethauer noted the need for longer-term outcome data to assess its potential as a primary bariatric procedure. Increasing the biliopancreatic limb length Dr José Salinas, Digestive Surgery, Catholic University of Chile, Santiago, Región Metropolitano, Chile, reported that increasing the biliopancreatic limb is a safe and successful strategy for unsuccessful weight loss after RYGB. Nineteen patients underwent BPD revisional with this surgical modification of primary gastric bypass. All cases were performed with a laparotomy. Revisional procedure was indicated for unsuccessful weight loss in all cases. Median time from primary to revisional surgery was 3.9 (range 1.3 – 6.2) years. Mean preoperative BMI was 45.4±6.9. Most patients (78.9%) had obesity-related comorbidities. There were no major early complications. On follow-up there were two (10.5%) patients with an internal hernia. Mean excess weight loss (EWL) was 41.9% in patients followed for a median of 1.5 years after revisional surgery. An accumulated EWL of 72.4% was observed since the first surgery. Ten-year trial: bypass beats band A trial designed to assess outcomes for patients receiving laparoscopic adjustable gastric banding (LAGB) vs. laparoscopic Roux–en-Y gastric bypass (LRYGB) has reported bypass has better weight loss and reduced number of failures, despite significantly longer operative time and life-threatening complications. Dr Luigi Angrisani and colleagues from the General and Laparoscopic Surgery Unit, San Giovanni Bosco Hospital, Napoli, Italy, said that this prospective, randomised clinical trial was established to provide much-needed data comparing the two most common bariatric procedures. From January 2000 to November 2000, 51 patients aged 19 to 50 were randomly allocated into two groups. Group A consisted of 27 patients who received LAGB via pars-flaccida; the remaining 24 patients were allocated into group B and received standard LRYGB. Baseline patient demographics revealed that the vast majority of LAGB patients were female (22 out of 27), had a mean age of 33.3 (range 2152), a mean weight: of 120kg (range: 92-150kg), a mean BMI of 43.4 (range: 40.1-49.2); and a 83.8% excess weight (range 36.9-128.8). Baseline patient demographics in the LRYGB showed the majority were female (20 out of 24), and had a mean age of 34.7 (range 20-50). Their mean weight was 120kg (range 95-147kg), a mean BMI 43.8 (range 40-48.9) and 83.3% excess weight (range 34.6-126.53). Results The operative time, re-operation with hospital stay, weight, BMI, and %EWL, were collected; procedures in the study were considered to have failed if BMI was over 35 at the endpoint. Data were analysed by Student t-test (p>0.05 is considered significant). Mean operative time was 60 minutes for group A and 220 minutes for group B (p>0.001); no deaths were reported. Five LAGB patients and three LRYGBP patients were lost to follow-up. The re-operation rate (p=ns) was 8/22 (36%) compared with 3/21 (14%). Hospital stay ranged from two to three days in group A and one week to six months in group B. After ten years, the mean weight was 101±22 and 83±18kg, BMI was 36±7 and 30±5, mean %EWL was 46±27 and 69±29, with failure rate 7/14 (50%) and 4/21 (19%) in Group A and B respectively (p<0.001). Additionally, patients with BMI<30 were 3/14 (21%) and 10/21 (48%) in the same groups (p<0.001). The researchers concluded that LRYGB produces better weight loss and fewer failures compared with LAGB, despite significantly longer operative time and life threatening complications. However, the investigators noted that long-term nutritional sequalae of LRYGB are still unknown. LSG has the lowest rates of procedure-related morbidity According to the outcomes of a new study presented at the Annual Meeting when compared with other bariatric procedures laparoscopic sleeve gastrectomy (LSG) appears to have the lowest procedure related morbidity. “The aim of the study was to identify which of the bariatric procedures performed today is the safest in terms of procedure related morbidity,” said Dr Raul J Rosenthal from the Bariatric and Metabolic Institute and the Section of Minimally Invasive and Endoscopic Surgery, Cleveland Clinic Florida. “So we carried out a single institution retrospective review of our centre’s six year experience since LSG was introduced comparing the procedure with Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric band (LAGB).” Rosenthal and colleagues retrospectively analysed a prospectively collected database in morbidly obese patients that underwent bariatric surgery between 2005 and 2011. They identified and compared complications, hospital stay, readmissions and re-operations in patients that underwent all three procedures. A total of 2,433 bariatric procedures were performed during this period of time. There were no significant differences between the groups in terms of age, gender or BMI. Rosenthal explained that in his institution, banding is only applied to patients with a BMI 3550, whereas LSG is applied to all patients including the high risk and RYGB is applied to all patients with a BMI of >35. Outcomes Of those procedures 1,492 were RYGB, 602 LSG and 339 LAGB. The number of readmissions was minimal in all three groups with RYGB 1.7 times, LSG 1.3 times and 1.5 times for LAGB. The percentage of procedures requiring reoperations due to complications or failures was 7.7% in the RYGB group, 1.5% in the LSG and 15.3% for the LAGB. “LSG appears to have the lowest rate of re-operations when compared to banding and bypass, and surprisingly banding had the highest rate of re-intervention,” said Rosenthal. “The primary reason for removing bands was slippage, followed by failure and reflux.” The outcomes also revealed that average postoperative length of stay was longer following RYGB (3.75 days) compared with LSG (3.4 days) and banding (1.47 days). The leakage rate was 0.4% for the RYGB and 0.3% for the LSG (leakage rates are not applicable for LAGB). “One of the weaknesses of this study, as with all retrospective studies, is that patients were not Raul Rosenthal randomised,” he explained. “Therefore, it could be that there is a patient population in one group or another that could trigger a difference in the outcomes.” “However, I believe that this study adds to the body of evidence, which includes randomised studies and meta-analyses, that LSG is an outstanding treatment option for morbid obesity,” concluded Rosenthal. “I think the message from this relatively small study is that at this point LSG is the safest procedure when treating morbidly obese patients.” The co-authors of the study were Drs Abraham Fridman, Karan Bath, Andre Teixeira and Samuel Szomstein. High GDI best indicator of diabetes remission after bypass Pancreatic function, and not initial BMI, is the best indicator of diabetes remission after Roux en Y gastric bypass, according to a new study. The study, ‘Predictors for Remissions of Type 2 Diabetes Mellitus Following Roux En Y Gastric Bypass’, found that 67% of gastric bypass patients achieved diabetes remission one year after surgery, but that number grew to more than 96% if patients were not already on insulin and did not have reduced pancreatic function as measured by the glucose disposition index (GDI). If GDI was 30% of normal, patients were less likely to achieve remission. The study also found that neither patient’s initial weight before surgery, nor weight loss both after six weeks and one year, had no impact on remission rates. “The study shows beta cell function, the cells in the pancreas that produce insulin, and insulin dependence, not initial weight or subsequent weight loss, are the greatest predictors of potential diabetes remission after gastric bypass,” said Richard A. Perugini, MD, a bariatric surgeon at University of Massachusetts Medical Center in Worcester and lead study author. “The study further confirms type 2 diabetes becomes more difficult to manage as it progresses.” The study included 139 gastric bypass patients aged 48 to 57, with BMIs ranging from 33 to 75. All required medication to manage their type 2 diabetes. 36% of patients no longer needed diabetic medication within two weeks of surgery, rising to 46% at six weeks, 57% at six months and 67% after one year. However, over 96% of patients on diabetes medications other than insulin and with a GDI that had not fallen below 30 percent of normal achieved remission. All patients’ HbA1c levels fell from an average of 6.9% to 6.1% over the period of the study. Patients achieved an average of 59% EWL and 15 BMI points after one year. Co-authors for the study included John J. Kelly, MD, Philip Cohen, MD, Donald R. Czerniach, MD and Karen A. Gallagher-Dorval, RN. BARIATRIC NEWS 11 ISSUE 13 | AUGUST 2012 2 San Diego, CA Are gender and race indicators of weight loss? Two studies presented at the recent ASMBS meeting in San Diego indicate that a patient’s race is a factor affecting weight loss following bariatric surgery. In a the first study, researchers from the Einstein Healthcare Network in Philadelphia reported that African-Americans and males lost significant weight after gastric bypass surgery, but not as much as their white and female counterparts. The study found African-Americans lost about 10% less of their excess weight than whites, while men of all races lost 10% less than women. Increasing age and higher initial weight were also identified as significant factors in predicting weight loss. The study examined 1,096 gastric bypass patients with at least one-year follow-up. Patients were on average 45 years old, and had an average BMI of 47.6. Excess weight loss was 63.2% in AfricanAmerican patients and 71.9% in white patients, and 63% in males compared to 71% in females. Resolution or improvement of obesity-related conditions, including type 2 diabetes, hypertension and sleep apnea, were similar across all groups. “The improvements in health status are consistent among all groups, however, for some reason, weight loss itself is variable,” said Dr Ramsey M Dallal, chief of bariatric/minimally invasive surgery at Einstein Healthcare Network. “Further study is needed to determine what makes some groups more resistant to weight loss than others. It is likely there are many factors, from genetics to environment.” In the second study, by investigators from Duke University, African-American women lost about 10% less of their excess weight after gastric bypass Bariatric surgery turns back kidney disease Severely obese patients with chronic kidney disease saw significant improvements in their condition within one year of bariatric surgery, a new study has revealed. Patients in the study, called ‘Improved Renal Function 12 Months After Bariatric Surgery’, went from having moderate kidney disease to mild kidney disease, or from mild kidney disease to normal function, within one year. “With bariatric surgery we are attacking the two main culprits of chronic kidney disease – high blood sugar and high blood pressure,” said study co-author Wei-Jei Lee, from Min-Sheng General Hospital and National Taiwan University Hospital. “However, this study suggests the earlier we treat chronic kidney disease in the disease process with bariatric surgery, the more favourable the impact on the kidney.” The study included 233 patients who were on average 33 years old and had a BMI of 39.5. Around 20% of the patients in the study had mild to moderate chronic kidney disease, and 25% of patients had hyperfiltration, a precursor to the disease. More than 90% had type 2 diabetes and almost 50% had hypertension – the two main causes of chronic kidney disease, according to the National Kidney Foundation. Dr Lee and his coinvestigators found that the patients’ glomerular filtration rate (GFR), a test used to check kidney function, improved regardless of the initial state of the patient’s kidneys. GFR rose from 81.0 to 98.6ml/min in the mild disease group, and from 49.3 to 66.8ml/min in the moderate disease group. Ordinarily, GFR ranges from 90 – 120ml/min. Patients in the study who had hyperfiltration, a precursor condition to kidney disease, saw their GFR drop from an average of 146.5 to 133ml/min. Study co-authors from MinSheng General Hospital and National Taiwan University Hospital included Chun-Cheng Hou, MD, Shu-Chu Chen, RN, Professor Yi-Chih Lee, JungChien Chen, MD, and KongHan Ser, MD. than their Caucasian counterparts, but if type 2 diabetes was present, weight loss and the rate of diabetes remission was about the same. The researchers said that while race may have been a factor in weight loss, it did not play a role in surgery’s effect on type 2 diabetes and in weight loss among people with type 2 diabetes. Both African-American and Caucasian women experienced similar diabetes remission rates (75% and 77%, respectively). Larger differences occurred in excess weight loss among women who did not have diabetes. African-American women on average lost 56.7% of their excess weight over three years, while Caucasian women lost 64.7%. However, if diabetes was present, the weight loss gap narrowed. African-American women with diabetes lost on average 59.8% of their excess weight. “For some reason, diabetes was the great equaliser when it came to weight loss,” said Dr Alfonso Torquati, Duke University, co-author of the study. “African-American women with Type 2 diabetes lost a similar amount of excess weight as Caucasian women. Racial differences in excess weight loss only emerged between non-diabetic women. Further study is needed to determine if the reasons are genetic or because of differences in body fat distribution or both.” The 282-patient study compared the outcomes of African-American women to Caucasian women matched for initial BMI, age and health status. On average, women were 40 years old and had a BMI of 50. About 20% of the patients had type 2 diabetes. Nearly 70% of African-Americans had hypertension, compared with 50% of Caucasians, and about one third of both groups had sleep apnea. Prophylatic IVC filter insertion: “more risks than benefits” The risks of inserting prophylactic inferior vena cava (IVC) filters in bariatric patients exceed the benefits, and the practice should be discouraged, according to a new study. The study, “Peri-operative complications in bariatric surgery patients undergoing prophylactic inferior vena cava filter insertion”, found that patients who received a filter had higher adjusted rates of venous thromboembolism, serious complications, and death. The new study follows advice from the US Food and Drug Administration that such filters should be removed as soon as protection from pulmonary embolisms is no longer needed, as extended insertions can lead to complications like lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization and inferior vena cava perforation. The study, performed by Birkmeyer et al, analysed data from 29,326 patients included in the prospective statewide clinical registry of the Michigan Bariatric Surgery Collaborative, between 2006 and 2011. Researchers used logistic re- gression to assess relationships between IVC filter insertion and complications within 30 days of surgery, while controlling for patient risk factors, bariatric procedure type, and propensity score. 3.5% of the patients (1,018) underwent filter placement before their operation, 62% of whom had no history of venous thromboembolism. 0.43% of patients with IVC filters had venous thromboembolism, compared to 0.21% in the population of patients without filters (p=0.019). 2.8% of the IVC group had serious complications; only 2.0% of patients without IVC filters did (p = 0.038). The mortality rate in the IVC and non-IVC groups was 0.2% and 0.05% respectively (p=0.013). Of the patients with IVC filters that died, four had pulmonary embolism and two had IVC thrombosis/occlusion. Other serious IVC filter specific complications included IVC filter migration in two patients. The study is the second that the group has performed concerning IVC filters in bariatric patients; the first, “Preoperative placement of inferior vena cava filters and outcomes after gastric bypass surgery” (Ann. Surg.. 2010 252(2):313-8.) found a lack of benefit of filter insertion for the prevention of pulmonary embolism in bariatric patients, but did not have the statistical power to prove harms associated with the practice. Trio of studies underlines sleeve gastrectomy safety Three new studies presented at the Annual Meeting have shown that laparoscopic sleeve gastrectomy offers comparable safety to gastric bypass and gastric banding. In one study, Stanford University researchers analysed safety data from the BOLD database, including nearly 270,000 metabolic and bariatric surgeries performed between 2007 and 2010. Almost 6% (nearly 16,000) of the surgeries were sleeve gastrectomies, which had a 30-day serious complication rate of 0.96%, compared to 1.25% for gastric bypass and 0.25% for gastric banding. The 30-day mortality rate for sleeve gastrectomy was 0.08%, compared to 0.14% for gastric bypass and 0.03% for gastric banding. The ASMBS pointed out that this is lower than is typically associated with gallbladder or hip replacement surgery. Patients in the study saw their BMI drop by an average of 30% after one year (47.5 to 34.1) after sleeve gastrectomy, compared to 40% for gastric bypass and 20% for gastric bands. “In terms of risk and benefit, sleeve gastrectomy sits nicely between gastric bypass and adjustable gastric band,” said lead study author John Morton, MD, as- sociate professor of surgery and director adopted in America. “Sleeve gastrectomy has proven of bariatric surgery at Stanford Hospital itself to be a safe and effective option & Clinics at Stanford University. in patients with morbid obesity and Proof of safety this procedure should be considered a These data, along with several other large primary procedure for weight loss and studies published within the last two years, obesity-related disease improvement and were recently submitted to the Centers for resolution,” said Dr Robin Blackstone, Medicare & Medicaid Services (CMS), president of the ASMBS. as the agency considers a new national In a further study, researchers from coverage determination for laparoscopic Cleveland Clinic Florida reviewed safety sleeve gastrectomy for its beneficiaries. outcomes of more than 2,400 of their The CMS recently proposed coverage patients who had sleeve gastrectomy, for sleeve gastrectomy only as part of a gastric bypass or bariatric and metabolic randomised control trial, ruling that cur- surgery between 2005 and 2011. rently available evidence is insufficient The study found sleeve gastrectomy to support its widespread adoption. had the lowest complication and reoperaThe ASMBS disagree, and are keen tion rates of the three procedures. for sleeve gastrectomy to be more widely 1.5% of sleeve gastrectomies in the study required reoperation due to complications. This is much lower than for gastric band and gastric bypass, which resulted in 15.3% and 7.7% requiring reoperation respectively. On average, patients had a BMI between 44 and 48, were 46 years of age and had at least two comorbidities. A third study comparing sleeve gastrectomy with gastric bypass conducted by the Naval Medical Center in San Diego found while bypass patients lost more of their excess weight after the first year (72.3% versus 63.7%), there were no statistically significant differences in excess weight loss after two and five years. This study examined 486 patients. Half had gastric bypass and half had sleeve gastrectomy. Lin 12 BARIATRIC NEWS ISSUE 13 | AUGUST 2012 29th Annual Meeting June 17–22 2012 San Diego, CA Bypass surgery reduces risk of heart attack Gastric bypass surgery can lead to significantly reduced cardiac risk factors even seven years after the operation, according to new research presented at the ASMBS’ 29th annual meeting in San Diego. The study, ‘Long Term Improvement in Biochemical Cardiac Risk Factors Following Gastric Bypass’, found that 11 risk factors for heart attack, including total cholesterol, triglycerides and Creactive protein levels, remained greatly reduced in patients during long-term follow-up. “Patients significantly decreased their risk for having a heart attack within the first year of surgery and maintained that benefit over the long-term,” said lead study author John Morton, MD, associate professor of surgery and director of bariatric surgery at Stanford Hospital & Clinics at Stanford University. The study involved 182 patients who had surgery and follow-up beyond three years at Stanford between 2003 and 2011. Patients were 44 years old on average, and had an average BMI of 47. In up to seven years of follow-up, patients maintained 56% EWL on average. Almost 25% of patients were on statins before surgery: these were discontinued shortly afterwards. High sensitivity C-reactive protein fell by 80% (10.9 to 2.6mg/ dL), a result which Morton described as “astounding”. “This is significantly better than what the best medical therapy has been shown to achieve and underscores the inflammatory na- ture of obesity, which can be reversed with surgical weight loss,” said Morton. Patients saw a 40% increase in high-density lipoproteins, a 66% drop in fasting insulin levels, and a 55% drop in triglycerides. Researchers also noted significant decreases in blood pressure and diabetes markers like fasting insulin and hemoglobin A1c. The US government estimated that in 2008, annual obesityrelated health spending reached $147 billion, double what it was a decade ago. Study co-authors include Nayna Lodhia, Leanne Almario, Adam Eltorai, Jaffer Kattan, Matthew Kerolus, and Margaret Nkansah, all from Stanford University. Sleeve gastrectomy improves chances of organ transplant Morbidly obese patients with end-stage organ failure may increase their chances of successful organ transplantation by undergoing laparascopic sleeve gastrectomy, according to a new study presented in San Diego. The paper, ‘Laparoscopic Sleeve Gastrec- tomy Is Safe And Efficacious For Pre-Transplant Candidates’, examined 26 patients with an average age of 57, who presented with end-stage kidney disease (n=6) and severely compromised liver function (n=20). Within nine months of surgery, six patients had liver transplants, one patient had a kidney transplant, one had a combined liver and kidney transplant, and one patient’s kidney function improved to the point that he was taken off the transplant list. 16 more patients are currently on the transplant list and have lost enough weight to qualify for transplantation. The remaining patient in the study died four years after surgery while waiting for a transplant. There were six complications among the group. Researchers say most US centres will not perform organ transplantation in patients with BMIs of more than 35-40. The average starting BMI of the patients in the study was 48.3. “This study suggests sleeve gastrectomy may be performed safely in carefully selected morbidly obese patients with impending organ failure and the significant weight loss they achieve may make them more suitable candidates for transplantation,” said lead study author Matthew Yi-Chih Lin, MD, a bariatric surgeon at the UCSF School of Medicine. While the study had a relatively low number of participants, the study authors claim that it is the largest study to examine the impact of gastric sleeve surgery on pre-transplant patients. The patients in the study lost 17% of their excess weight at one month, 26% at three months, 50% at 12 months and 66% at two years. As well as the weight loss, seven of the 13 patients with type 2 diabetes showed complete resolution of the disease; one further patient was able to significantly reduce insulin use. According to the US government figures, there were 16,898 kidney transplant procedures in 2010, with 94,598 people on the waiting list. Liver transplants numbered 6,291, with 16,954 people on the waiting list. About one-third of people on organ transplantation waiting lists are obese and as many as 15% are morbidly obese. The surgeons in the study choose sleeve gastrectomy over other methods because the procedure avoids implantation of foreign bodies like gastric bands in immunosupporessed patients. It also maintains endoscopic access to the biliary system. The ASMBS is currently in a disagreement with Centers for Medicaid and Medicare Services (CMS) after the latter proposed coverage for sleeve gastrectomy only as part of a randomised control trial, ruling that currently available evidence is insufficient to support its widespread adoption. The ASMBS, among other medical groups, responded that the CMS did not consider all relevant evidence when making their decision. Co-authors for the study include Ankit Sarin, MD, Mehdi Tavakol, MD, Shadee M. Amirkiai, BS, Stanley J. Rogers, MD, Jonathan T. Carter, MD, Andrew M. Posselt, MD, PhD. Matthew Yi-Chih Lin EndoBarrier helps diabetes factors in the overweight The EndoBarrier duodenal- jejunal bypass liner leads to “substantial” metabolic improvement in overweight and mildly obese type 2 diabetes patients, according to new data presented at the annual meeting. In the study, ‘Metabolic Improvements in Type 2 Diabetes in Subjects Without Severe Obesity With the Endoscopic Duodenal-Jejunal Bypass Liner’, saw the diabetic factors HbA1c, fasting plasma glucose, and low-density lipoprotein, drop after 12 months. Three months after implant, 12 out of 19 patients (63.2%) exhibited HbA1c levels under 7.0%, the level at which diabetes is considered to be controlled. Eight out of 13 patients (61.5%) demonstrated HbA1c under 7% after 12 months. The Endobarrier’s inventors, GI Dynamics, are marketing the device as a potential cure for diabetes as well as for obesity. “Our data point to a substantial improvement in glycemic control and other metabolic parameters even among overweight – but not severely obese – diabetic patients during EndoBarrier Therapy,” remarked study lead author Dr Ricardo V Cohen, from the Center for the Surgical Treatment of Morbid Obesity and Metabolic Disorders, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil. Ricardo Cohen “These are promising data and suggest that EndoBarrier may play a valuable role for overweight patients struggling to control their diabetes and lose weight.” Method and results Twenty-three overweight and mildly obese patients (BMI 23-36) were enrolled for the study, all of whom had type 2 diabetes were treated with oral agents alone. 20 of the 23 subjects were successfully endoscopically implanted with the liner; three could not due to unfavourable anatomy. Over the 12 months of the study, there were four early endoscopic removals: twice because of device movement, once because of abdominal pain, and once after principal investigator request. Follow-up included monthly determinations of HbA1c, fasting plasma glucose, lipids, and percentage total body weight loss. At the start of the study, patient baseline HbA1c was 8.7±0.20%, fasting plasma glucose was at 197.5±16.8mg/dl, lowdensity lipoprotein was at 137.8±13.1mg/dl, triglycerides were at 226.1±35.5mg/dl, and average BMI was 30.2±0.83. The device remained in place for one year in 13 out of 17 patients (76.4%); three patients kept their devices in place after the endpoint of the study. At one year, the patients’ HbA1c had decreased by 1.3±0.37%, fasting plasma glucose had dropped by 44.1±20.7mg/ dl, low-density lipids had decreased by 25.6±7.0mg/ dl, and triglycerides by 42.5±17.3mg/dl. The patients’ total body weight loss dropped by 8.4±1.7%. Patients in the study were men and women between 18 and 55 years who had type 2 diabetes for ten years or less and were on oral diabetic medications. Their initial HbA1c levels were between 7.5 and 10%. EndoBarrier The EndoBarrier is an attempt to mimic the effect of the intestinal bypass component of the Roux-en-Y gastric bypass. The device has already been tested in a study by Escalona et al (Ann. Surg.. 2012 255(6):1080-5), which examined the benefits of the device in morbidly obese patients, in terms of weight loss and metabolic function. The study found that patients underwent significant weight loss and improvements in cardiometabolic risk factors after one year. EndoBarrier received CE Mark approval for Europe in 2010 as well as approval by the Therapeutic Goods Administration in Australia in 2011 for the treatment of type 2 diabetes and/or obesity. EndoBarrier is currently commercially available in some European markets, as well as Chile and Australia. BARIATRIC NEWS 13 ISSUE 13 | AUGUST 2012 CMS allows LSG procedures in some Medicare centres The Centers for Medicare and Medicaid Services (CMS) has announced its decision on coverage for the laparoscopic sleeve gastrectomy (LSG). The final decision will allow LSG to be covered by intermediary Medicare administrators as a stand-alone procedure at their discretion. Reversal The decision is a reversal of their proposed coverage, as reported in issue 12 of Bariatric News, to only allow coverage of LSG as part of a randomised, controlled trial. However, the announcement falls short of a national coverage determination. The CMS’ decision stated that Medicare Administrative Contractors acting within their respective jurisdictions may determine coverage of stand-alone LSG for the treatment of co-morbid conditions related to obesity in Medicare beneficiaries only when all of the following conditions 1–3 are satisfied: 1.The beneficiary has a BMI ≥35kg/ m2, 2.The beneficiary has at least one comorbidity related to obesity, and 3.The beneficiary has been previously unsuccessful with medical treatment for obesity. The decision statement also added that the CMS believes that the available evidence “does not clearly and broadly distinguish the patients who will experience an improved outcome from those who will derive harm such as postoperative complications or adverse effects from LSG.” However, in its statement the CMS does acknowledge the seriousness of obesity and the possible benefits of LSG in highly selected patients in qualified centres, and has therefore decided that local Medicare contractor determination “on a case-by-case basis balances these considerations in the interests of our beneficiaries.” The statement concluded that: “Our local contractors are in a better position to consider characteristics of individual beneficiaries and the performance of eligible bariatric centres within their jurisdictions. Therefore, Medicare Administrative Contractors acting within their respective jurisdictions will make an initial determination of coverage under section 1862(a)(1) (A) and we are not making a national coverage determination under section 1869(F).” ASMBS response In a response posted on the their website, the ASMBS commented: “On behalf of our patients, ASMBS is very pleased and gratified that CMS has recognised the true value and compelling need for coverage of this procedure. ASMBS will immediately initiate the formal pathway for coverage with each regional CMS intermediary.” The Society added that the overwhelming response from patients, surgeons and integrated health members, along with the strong evidence base for LSG, provided CMS with a “persuasive argument for LSG coverage”. In addition, they acknowledged that the multidisciplinary support of the American College of Surgeons, SAGES, The Obesity Society and the American Society of Bariatric Physicians displayed an Obesity Care Coalition in action working for patients’ best welfare. “We will now go forth to each individual intermediary, and this decision will open the door to widespread coverage based on the strong, available evidence. We are confident coverage will be achieved,” the statement concluded. The CMS had previously approved national coverage for Roux-en-Y bypass, laparoscopic adjustable gastric banding and biliopancreatic diversion with duodenal switch. Surgery results in positive social and health changes Bariatric patients reported an overall improvement in quality of life issues after surgery, according to a study by Arizona State University researchers presented at the 107th Annual Meeting of the American Sociological Association. The paper, “Social and Health Changes Following Bariatric Surgery,” assessed how bariatric patients felt post-surgery. The researchers collected data from 213 patients, aged from 26 to 73 years old (average age 50), via a self-selected sample of participants in an online support group. Researchers asked a variety of questions in the survey that was made available through an online support group for bariatric patients. Study questions examined physical health, self-esteem, social life, work life, family life, mobility and satisfaction with surgery results. “We thought there would be more negative reactions to the surgery, but the response was very positive,” said study co-author Jennie Jacobs Kronenfeld, an ASU School of Social and Family Dynamics professor. “Most people had improvements in chronic health problems.” The study also recorded the patients motivation to have the surgery. In order of importance they were: n to decrease the risk of health problems; n to improve overall health; n to improve appearance; and n to boost self esteem Health issues that respondents reported improvements in included diabetes, heart disease, cholesterol level and sleep apnoea. Study respondents also cited increased mobility as one of the positive aspects of having surgery to lose weight. Weight loss among participants averaged 95lbs per person while the range of weight experiences was wide (gaining 80lbs to losing 260 lbs). People who elected to have the surgery to reduce negative reactions to their weight among friends and family, reported better relationships after surgery. Respondents also reported a decrease in depression after the surgery. “This provides evidence that overcoming the stigma of being overweight, as reflected by negative reactions of others, can lead to greater satisfaction among relationships with family and friends, and in social life in general,” said Doris A Palmer, co-author of the paper and a doctoral student in the School of Social and Family Dynamics sociology programme at ASU. Satisfaction with how participants felt about their appearance was lower on average than satisfaction with other aspects after the surgery. “They were satisfied, but not as pleased about the way they looked as with other aspects of their lives,” said Kronenfeld. “They may have hanging skin and those kinds of issues to deal with. It's not clear if most insurance companies will cover treatment of those issues since it may be considered cosmetic.” ASMBS welcomes Medicare LSG decision Following the June 27th decision by the CMS to allow local coverage of laparoscopic sleeve gastrectomy (LSG), bariatricnews.net discussed the decision and its implications, with Dr John Morton, chair of the ASMBS’ Access to Care Committee. What was your initial reaction the CMS’ decision? My initial reaction was gratification that the CMS realised that their proposed solution of creating a randomised controlled trial was not the best step forward for patients in need. The solution now is to allow the regional administrators to decide if they are going to cover LSG. The ASMBS is currently in discussions with regional administrators to ensure there will be LSG coverage for Medicare patients. Given the proposed decision announced in March 2012, were you surprised by the U-turn? We were hopeful that they would change their mind, but there is never any sort of guarantee. We were just very pleased that they were able to recognise the additional evidence-based data we submitted. In fairness to the CMS, when they carried out the original review there was a considerable amount of unpublished data that was not available to them. Soon after the CMS’ proposed decision in March, there were four randomised, controlled clinical trial papers published in quick succession. So the facts on the ground changed and I think CMS was quite prudent in recognising the new data and subsequently allowing LSG coverage. So we are grateful that the CMS has acknowledged the strength of the data and that LSG does play an important role in what is our leading public health problem. We need more tools at our disposal and the LSG is a very powerful addition to our arsenal in dealing with obesity. The CMS stipulated that Medicare beneficiaries must have a BMI>35, at least one co-morbid condition related to obesity (e.g., diabetes, heart disease), and have previously been unsuccessful with medical treatment for obesity. Do you agree with these requirements? Yes, the requirements the CMS proposed are consistent with those that have been in place for many, many years stemming from the 1991 National Institutes of Health’s NIH Consensus Statement on Bariatric Surgery. So these requirements do not represent any significant change. Regarding the patients with a BMI between 30–35, we are accruing more data and I think it is becoming clear that patients, particularly diabetic patients within this weight range would benefit greatly from bariatric surgery. From a cost standpoint, if you look at some of the newer drugs to treat diabetes they are fairly expensive particularly in the long-term. Therefore, I think this will be a discussion that will take place sooner rather than later. What other aspects of the decision were you pleased to see? The CMS proposal from March was focused on the elderly, which is a small percentage of the overall Medicare population. The majority of the obese, Medicare population who need assistance are the disabled and the leading cause of disability in my own home state of California is obesity. The other group to mention are those patients with end-stage renal disease, who are the only group of patients in the US who are guaranteed medical insurance coverage. This group of patients really could benefit from LSG as they are potential transplant candidates and those of us in the bariatric community see LSG as the ideal procedure for both pre- and post-transplant patients. This is because there are reduced risk around medical absorption, no risk of an in dwelling foreign body on immune suppression, so in many ways it the most suitable procedure. It is important to remember that no field of medicine treats a single disease with a single medication or procedure, and bariatric and metabolic surgery is the same. We need any many options on the table as possible to try and treat what is a very challenging disease. How much do you think the CMS was influence by the actions and additional submissions of the ASMBS, SAGES, ASBP etc? I think it played a significant role. Perhaps more importantly, I think it demonstrated that we work best when we work together and we showed that our interests are not parochial around the surgical field. We are well and truly in the obesity field and looking to get all the possible tools at our disposal. I think it also showed what it takes to rally the surgical and patient community. The ASMBS, working with the Obesity Action Coalition, was able to get the word out and mobilise patients and surgeons alike. For example, there were well over 400 submissions received during the comment period and the vast majority spoke in favour of LSG. This was a huge increase from the 150 comments the CMS received in the previous comment period. I think it was really encouraging to see this level of support. For our readers outside of the USA, could you explain the CMS’ decision to allow local Medicare contractors to decide coverage and whether this will mean a patient’s location will determine if they are eligible? This is something that is currently being discussed. In general, most of the regional administrators work in closely together, so this allows the CMS to reach an appropriate conclusion and gives them a degree of flexibility on a regional level. We are hoping to reach out to all regional administrators and convince them that LSG coverage is the way forward. What are the next steps the ASMBS will take in regards to gaining national coverage for LSG? We will be publishing additional data from the BOLD database, which showed that LSG was positioned between the bypass and the band in terms of safety and efficacy. We will also be reaching out to the regional administrators and to try and ensure that everybody who means the criteria has the opportunity to receive the procedure. The CMS’ decision is a positive one for patients and the experience has been a positive one for the surgical community as we have been able to put patient safety at the centre of the argument, supported by evidence-based medicine. Ultimately, the decision is a positive one for the country as we are going to be able to treat many individuals who will be able to lead a more productive and fulfilling role in society. John Morton 14 BARIATRIC NEWS ISSUE 13 | AUGUST 2012 Coffee time with Pradeep Chowbey Bariatric News speaks to Dr Pradeep Chowbey, Director – Max Institute of Minimal Access, Metabolic & Bariatric Surgery, Max Healthcare, New Delhi and Congress President of the XVII World Congress of the International Federation for the Surgery for Obesity and Metabolic Disorders – IFSO 2012, New Delhi, India. Why did you decide to enter advanced laparoscopic procedures and we believed that the technology medicine? I am from a small community and the most important person in the community was the doctor. The doctor treated everyone including other respected professionals such as lawyers, judges and teachers. My father was also a doctor (a surgeon). I grew up with people of all stature visiting my house. They were very respectful towards my father, seeing him as altruistic, generous and helpful. Growing up, this was a very strong motivation for me. Why did you decide to specialise in bariatric surgery? Bariatric surgery is very demanding and each case presents different challenges. But it is also very rewarding enabling patients to eradicate a very sinister disease, which not only contributes to other diseases such as diabetes, heart and kidney disease, but in itself ruins the patients’ quality of life. A bariatric surgeon helps to eradicate not only obesity but also its associated diseases. As I attended more conferences and workshops around the world, I could see an increasing focus on laparoscopic procedures for obesity. At the time, there were very few patients presenting with morbid obesity in India. However, we knew that with the country’s rapid economic growth this would increase and in the late 1990s we began to see an increase in the number of morbidly obese patients. We were already performing quite could bring great benefits to this group of patients. Many people, including some doctors, were not aware of the problems associated with obesity, so we faced many issues educating people about the benefits of surgery. However, there was also a need to educate the wider population. I was the Surgeon to the President of India, so I was fortunate to be in a position where I could interact with the high officials and policy makers to make them aware of the menace of obesity hovering our country. As a result, we were able to influence policy and created an obesity awareness campaign in schools and media. Who have been your greatest influences and why? My father has been the greatest influence on my career, not only for his surgical attributes but also for his humanitarian attributes. I was also greatly influence by Professor O P Mishra, who was a meticulous surgeon and dedicated to his patients. He would remain with the patients following surgery in case there was an emergency. He was a great inspiration to me! What experience in your training has taught you the most valuable lesson? When I started my surgical training abscesses (collection of pus in the body) used to be very common. We were taught that the first course of action was to make an incision and drain the pus. This was seen as a critical intervention and the earlier you performed the intervention, the better resident you were. This taught me the important lesson to understand the suffering of the patients and it was deeply imbedded in my psyche. I still uphold these principles today. Tell us about one of your most memorable career experiences? The most important moment in my career was when I operated on His Holiness the Dalai Lama. I had previously operated on the president of India, which was a great honour and at that time I thought that it was the pinnacle of my career. In 2008, I had the honour of operating on the Dalai Lama and I realised that he may not be the chief of a nation, but jewel of the world and who ruled the hearts of people all over the world. He is seen as the incarnation of Buddha and is seen all over the world as a great man. I was deeply honoured to have been chosen by him to be his surgeon. It gave me a tremendous sense of achievement. It was a great lesson of peaceful existence in the world. When I met him he told me he knew about me, not by name, but by my face. He knew four years previously that he would require surgery and decided on the features of his surgeon – he is a man of great intuition. Can you tell us about your obesity awareness campaign in India over the last decade? The disease of obesity is probably the most expensive to treat or manage because it can lead to so many other conditions. This is why it is important to make people aware of its dangers and educate our patients. When we began the awareness programmes in schools, I asked the teachers to explain to parents about the body mass index and the dangers associated with an increasing BMI. I also made presentations to the president of India and the Ministry of Health. Of course, the priority in our country and the Indian sub-continent are infectious diseases so there are few resources available to help prevent or treat lifestyle diseases. How should we tackle the obesity pandemic? By awareness and education, A country like India cannot afford an obese population. We have to make sure obesity awareness is taught in schools and children grow up knowing the dangers of the disease. We know that 80% of obese children will continue to be obese throughout their lives. Everyone should know their BMI, should know the effects obesity has on the human body and the long-term effects obesity could have on their health. What are the biggest challenges facing bariatric surgeons in India over the next ten years? The lifestyles of the population have changed so dramatically over such a short period of time that the vast majority of people do not realise that the ever increasing levels of obesity are counter-productive. In regards to surgery, one of the biggest challenges is that in order to have surgery patients must pay cash, as insurance does not cover bariatric surgery. In the near future, I would like to see insurance coverage of bariatric procedures. Not only will this provide many more people with the opportunity to have life-saving surgery, but it will also increase awareness about obesity. It will be in the insurance company’s Turning white adipose tissue into brown adipose tissue Researchers at the Columbia University Medical Center (CUMC) claim to have identified a mechanism that can give energy-storing white adipose tissue (WAT) some of the beneficial characteristics of energy-burning brown adipose tissue. The study could have implications for how new treatment strategies for treating obesity and type 2 diabetes are developed. The study was published in the journal Cell (2012 Aug 3;150(3):620-32). “We have known for a long time that WAT stores excess energy as triglycerides, whilst BAT burns energy as heat,” said study leader Dr Domenico Accili, professor of medicine and the Russell Berrie Foundation Professor at CUMC. “Turning WAT into BAT is an appealing therapeutic approach to staunching the obesity epidemic, but it has been difficult to do so in a safe and effective way.” Previous research has shown that by using thiazolidazines (TZDs) it is possible to turn WAT into BAT (a process called “browning”), as they activate a cell receptor called peroxisome proliferator-activated receptor-gamma (ppar-gamma). However, the exact mechanism had not been identified. In addition, the use of TZDs has so far been limited due to their adverse effects including liver toxicity, bone loss and weight gain. The Columbia University study was undertaken to learn more about the function of TZDs, with the ultimate goal of developing better ways to promote the browning of WAT. Accili and his colleagues studied a group of enzymes called sirtuins, which are thought to affect various biological processes, including metabolism. The researchers had previously shown in mice that when sirtuin activity increases, so does metabolic activity. In the present study, they found that sirtuins boost metabolism by promoting the browning of WAT. Sirtuins work by severing the chemical bonds between acetyl interest to increase awareness about the dangers of obesity. A second challenge is to create more centres of excellence of bariatric surgery in and around our major cities. We need to train and equip large numbers of healthcare professions for the inevitable rise in patients. What are you current areas of research? We will soon be publishing the five-year results from a clinical study looking the outcomes for 200 patients with low BMI’s of 27 to 32.5. This study included the study of procedures such as sleeve gastrectomy and gastric bypass, and I believe the five-year outcomes, in terms of diabetes resolution, are quite exciting. We expect to publish the results in the next six months. Away from surgery, how do you relax? My biggest relaxation is to be with my family, my wife, my son and daughter. All four of us are interested in fine art and enjoy visiting galleries, exhibitions and auctions. I particularly enjoy speaking with artists and learning about what inspires them and discussing the emotions they feel when creating their works of art. When we are travelling on holiday, we always visit places that have a rich collection of museums and galleries. What can delegates enjoy away from the Congress? Our country is such a wonderful place to visit and our colleagues from all over the world should come and experience the warm hospitality of India. India has something for everyone and is a country with a rich cultural history including one of the Seven Wonders of the World. And of course, the World Congress will be blessed by his holiness the Dalai Lama, and delegates will be able to ask him questions about his latest book, Beyond Religion: Ethics for the whole world. This will be a unique experience for all attendees. groups and proteins, a process known as deacetylation. “When we sought to identify how sirtuins promote browning, we observed many similarities between the effect of sirtuins and that of TZDs,” said lead author Dr Li Qiang, associate research scientist in Medicine at CUMC. “So the next question was whether sirtuins remove acetyl groups from ppar-gamma and, indeed, that was what we found.” To confirm that the deacetylation of ppar-gamma is crucial to the browning of fat, the researchers created a mutant version of ppargamma, in effect mimicking the actions of sirtuins. The mutation promoted the development of BAT-like qualities in WAT. “Our findings have two important implications,” said Accili. “First, they suggest that TZDs may not be so bad if you can find a way to tweak their activity. Second, one way to tweak their activity is by using sirtuin agonists, that is, drugs that promote sirtuin activity.” “The truth is, making sirtuin agonists has proved to be a real bear, more promise than fact,” he added. “But now, for the first time, we have a biomarker for good sirtuin activity: the deacetylation of ppargamma. In other words, any substance that deacetylates ppar-gamma should in turn promote the browning of white fat and have a beneficial metabolic effect.” The additional researchers were Ning Kon (CUMC), Wenhui Zhao (CUMC), Sangkyu Lee (University of Chicago), Yiying Zhang (CUMC), Michael Rosenbaum (CUMC), Yingming Zhao (University of Chicago), Wei Gu (CUMC), and Stephen R Farmer (Boston University School of Medicine). Our new website… The world of bariatric surgery is changing. New Created in consultation with bariatric specialists like you, research and technologies are transforming the bariatricnews.net is the first online newspaper dedicated to the way that you work. You need to know what’s treatment of obesity and metabolic disorders for medical happening, as it happens. professionals. Launching in September. Bariatricnews.net Stay informed. Advert Get involved. Register your interest and be kept informed with regular updates: email [email protected]. Follow us on Twitter: @bariatricnews Like us on Facebook: facebook.com/bariatricnews If you’ve got an idea for an article, suggestions for topics to cover, or would like to take part in a debate, we’d love to hear from you. Email [email protected]. Be heard. Send press releases to [email protected]. For advertising options, email [email protected]. News Conference reports Clinical research, new technologies, policy, and guidelines, as they happen. Official news from IFSO. Reporting with exclusive news, videos, and photos from IFSO, ASMBS, Alpine Experts, Non-Inva, and many more. Events Features Advert Listings for the best bariatric meetings, conferences, seminars, and training sessions around the world. Reports, case studies and head-to-head debates covering every aspect of bariatric surgery and metabolic disease. Interviews Opinion & blogs In-depth profiles of the most prominent bariatric thought leaders. Opinions, experience, and commentary, directly from the international professional community. 18 BARIATRIC NEWS ISSUE 13 | AUGUST 2012 ISSUE 13 | AUGUST 2012 BARIATRIC NEWS 19 20 BARIATRIC NEWS ISSUE 13 | AUGUST 2012 Surgery quality varies widely in US Bariatric surgery is quicker, safer and cheaper in higher-quality hospitals, but US care provision varies widely, according to a new report. The report, “Choosing Bariatric Surgery to Improve Overall Health”, examined the outcomes of 201,821 bariatric operations between 2008 and 2010, and found that while bariatric surgery was generally safe, there was a large amount of variation between levels of service offered by hospitals around the country. The paper also reported that bariatric procedures in the 478 hospitals included in the study dropped by 6.39% over the three years, from 69,724 procedures in 2008 to 63,868 procedures in 2010. It reported on a total of 201,821 operations. The report, published by health care provider rating company HealthGrades, measured results from 478 hospitals in 19 states, rating them as fivestar, three-star or one-star locations. They found that patients in five-star programmes were 72.26% less likely to experience an in-hospital complication than patients at one-star programmes. HealthGrades say that their hospital ratings are independently created; no hospital can opt in or opt out of being rated, and no hospital pays to be rated. The in-hospital average complication rate for one-star hospitals was 11.79%, compared to 3.03% for five-star hospitals. HealthGrades calculate that 5,788 patients in their study could have avoided a complication if the one-star centres had performed at the same level as the five-star centres. Patient volume also had a significant effect on complication rate: 7.99% of procedures in hospitals that performed under 75 operations in the three-year period suffered from a complication, compared to 5.71% of patients in centres performing over 375 operations in three years. Patients had an average stay of 1.88 days after their operation in five-star programmes, half a day less than the average 2.37-day stay in one-star programmes. One-star hospitals charged on average $3,189 more than five-star programmes, a fact that the report suggested may be due to the higher rate of complications in the poorer-quality centres. Geographical differences Cost and provision of bariatric surgery differed dramatically across the 19 states that were studied. The most inpatient procedures were performed in California, New York, and Texas, with 19.25%, 12.85% and 11.86% of the total procedures respectively. Collectively, Iowa, Utah and Rhode Island performed less than 3% of inpatient procedures. Massachusetts and North Carolina showed large increases in the number of inpatient bariatric procedures, with an increase of 29.7% (3,771 to 4,891) and 24.65% (2,974 to 3,707) respectively; meanwhile, Arizona, Rhode Island and Virginia experienced declines in the number of inpatient bariatric procedures, with drops of 31.61% (2,249 to 1,538), 30.87% (554 to 383) and 30.23% (3,166 to 2,209) respectively. The most expensive state to receive a bariatric operation in was found to be California, where the average charge was $56,744 for a laparoscopic procedure and $69,963 for an open procedure; meanwhile, a laparoscopic procedure in Maryland cost on average $15,631 and an open procedure $18,406. The study found that the average cost for a laparoscopic procedure was $41,594, and $45,137 for an open procedure. Sharp drop in US gastric band operations The number of laparoscopic gastric band operations in the US dropped by around 20% since 2011, indicating scepticism in the country’s medical community over its efficacy and the increasing popularity of new operative techniques. In their second-quarter earnings call, released August 1, Allergan, manufacturer of the Lap-Band, reported that gastric banding had a 33% share of the bariatric market in May 2012, down from “the low forties” in 2011. David Pyott, CEO of Allergan, said that banding in the US was losing to gains in laparoscopic sleeve gastrectomy, which had garnered a 31% share of US operations in May 2012. Although Allergan’s secondquarter 2012 international net product sales across their entire product range were 8.7% up on the previous year and secondquarter earnings were up yearon-year, their obesity intervention line declined 24.1%. Allergan’s bariatric product line consists of two products: the Lap-Band, and the Orbera gastric balloon, which sells outside of the USA. Pyott said that it was “encouraging” that the decline in the overall US bariatric market is flattening, saying that the rate of decline in the last three months to may was estimated at 2%, compared to 6% throughout 2011. However, he admitted that in a time of high unemployment, high patient co-pays were a barrier for many, even in patients with insurance coverage. Following the publication of the financial results, Allergan’s stock price jumped 10.5%, from $82.07 to $90.68. Gastric bands Allergan’s financial results point to a diminishing role for laparoscopic gastric bands in US bariatric surgery. Their Lap-Band makes up 90% of the US gastric band market; the only other FDA-approved band is Ethicon’s Realize system. While gastric bands generally result in fewer serious complications than Roux-en-Y gastric bypass, several studies suggest that it is less clinically effective over the long term. Dr Luigi Angrisani recently reported that in his 10-year study, bypass patients were likely to lose more weight and keep it off for longer than band patients. Another recently published six-year case-matched study reported that Roux-en-Y gastric bypass is associated with better weight loss, resulting in a better correction of some comorbidities than gastric banding. Sleeve gastrectomy is often seen as a useful midpoint between gastric bypass and gastric banding: more effective than banding, and with fewer complications than bypass. In America, the Centers for Medicare and Medicaid Services recently announced the operation could be supplied by some Medicaid administrators. Obesity drugs While the FDA have recently approved two anti-obesity drugs in the USA – Belviq and Qsymia – Pyott said he did not see them as a further threat to Allergan’s two obesity products. “It’s a different type of patient in terms of the number of kilos they want to lose, and I think that touches much more diet change and exercise,” he said. Covidien Meanwhile, reported a third-quarter rise in net sales of 3%, which included sales of $2.06 billion in their medical devices division, fuelled in part by double-digit gains for their line of staplers. Johnson and Johnson, who own Ethicon EndoSurgery, reported second-quarter sales of $16.5 billion, a year-on-year decrease of 0.7%. BARIATRIC NEWS 21 ISSUE 13 | AUGUST 2012 Bypass surgery alters gut microbiota profile Study urges Vitamin D deficiency screening Gastric bypass surgery induces changes in the gut microbiota and peptide release, a study presented at the Annual Meeting of the Society for the Study of Ingestive Behavior has found. Previous animal research has shown that ingestion of a highfat diet produces weight gain and profoundly affects the gut microbiota composition, resulting in a greater abundance of phyla bacteria called Firmicutes, and a decrease in Bifidobacteria spp and Bacteroidetes (Cani et al, J. Nutr. Biochem. 2011 22(8):71222, Cani et al Diabetes. 2007 56(7):1761-72 and Diabetologia. 2007 50(11):2374-83, de Wulf J. Nutr. Biochem. 2011 22(8):712-2) . A similar pattern has also been found in obese humans. Feeding of prebiotics, substances that enhance the growth of beneficial bacteria, changes the composition and/or the activity of the gastrointestinal microbiota, to promote the release of gut peptides and to improve glucose and lipid metabolism in diet-induced obese and type 2 diabetic mice. “Our findings show that Roux-en-y gastric bypass (RYGB) surgery leads to changes in gut microbiota that resemble those seen after treatment with prebiotics,” said lead author of the study, Dr Melania Osto, Institute of Veterinary Physiology, Vetsuisse Faculty University of Zurich, Switzerland. “The results of this study suggest that postsurgical gut microbiota modulations may influence gut peptide release and significantly contribute Adolescents should undergo to the beneficial metabolic effects of RYGB surgery.” In her presentation, Osto said that recent studies have reported substantial shifts in the composition of the gut microbiota towards lower concentrations of Firmicutes and increased Bacteroidetes in obese subjects after RYGB (Furent el at Diabetes. 2010 59(12):3049-57, Zhang et al Proc. Natl. Acad. Sci. U.S.A.. 2009 106(7):2365-70, Bueter et al, J Vis Exp. 2012 Jun 11;(64)). Most of the human studies on gut microbiota have been carried out using faecal samples, which may not accurately represent how RYGB Melania Osto surgery affects the gut microbiota profile along different parts of the intestine. This new measured the bacterial composition and the amounts of different peptides that affect food intake along different intestinal segments after RYGB in rats. They reported that 14 weeks after surgery, Bifidobacteria spp, and Bacteroides-Prevotella spp content were significantly increased, especially in the small intestine of the RYGB rats compared with control animals. Osto concluded that following RYGB, not only do changes in gut microbe populations resemble those seen after treatment with prebiotics, but microbiota changes were also associated with altered production of gastrointestinal hormones known to control energy balance. vitamin D deficiency screening before having bariatric surgery, according to research presented at The Endocrine Society's 94th Annual Meeting. The study, carried out researchers at Columbia University Medical Center, New York, found that the majority of adolescents preparing for surgery were deficient in vitamin D. “This is particularly important prior to bariatric surgery where weight loss and decreased calcium and vitamin D absorption in some procedures may place these patients at further risk particularly as they have not reached their peak bone mass,” said study lead author Dr Marisa Censani, pediatric endocrinology fellow at Columbia. “These results provide insight into prevalence and risk factors for pre-existing vitamin D deficiency in obese adolescents prior to bariatric surgery.” While previous studies have found an increased risk of vitamin D deficiency among adults evaluated for weight-loss surgery, whether this deficiency also occurred among morbidly obese adolescents remained unclear. The investigators conducted the study to determine the prevalence of vitamin D deficiency in morbidly obese adolescents evaluated for bariatric surgery Study Investigators analysed the medical records of 236 adolescents who were being considered for bariatric surgery between March 2006 and June 2011. Of these patients, 219 provided medical records that included data on vitamin D levels. 65% were female, their average age was 16 years and a mean BMI 48.2. 43% were Caucasian, 35% were Hispanic and 15% were African American. The study defined levels of serum 25OHD as: n Adequate >30ng/mL nInsufficient 20-29 ng/mL nDeficient <20ng/mL n Severely deficient <10ng/mL Censani and her co-investigators found that 45% of adolescents undergoing evaluation for weight-loss surgery were vitamin D deficient and 9% had severe deficiencies (totalling 54% of the patient group). 29% and 17% had insufficient and adequate vitamin D levels, respectively. They also reported that patients with the highest BMIs were the most likely to be vitamin deficient, with each kilogram increase in BMI correlating with a 0.2ng decrease in 25OHD levels. The investigators also identified several racial differences and reported that African Americans (82%) were the most likely to be vitamin D deficient, followed by Hispanics (59%), while Caucasians (37%) were the least likely to have a deficiency. “These results support screening all morbidly obese adolescents for vitamin D deficiency, and treating those who are deficient, particularly prior to bariatric procedures that could place these patients at further risk,” Censani said. The NIH National Institute of Diabetes and Digestive and Kidney Diseases funded the study. 22 BARIATRIC NEWS ISSUE 13 | AUGUST 2012 IFSO news...IFSO news...IFSO news... Invitation Dear Esteemed Colleagues and Friends, and Bariatric Surgery, we feel On behalf of the Taiwan Society for Meta bolic to participate in the 2013 IFSO-Asia privileged to extent to you this cordial invitation take place at the Crowne Plaza Pacific Chapter Meeting, which is scheduled to April 10 to April 13, 2013. Hotel Kaohsiung E-Da World, Kaohsiung, Taiwan from regarded as the paradise of The Congress host country, Taiwan, has long been triggers calories that are absorbed gourmet cuisine in Asia. However, refined cuisine syndromes take on an ascending more easily, and as a result obesity and meta bolic nt of bariatric and meta bolic surgery trajectory. To solve this epidemic, the developme rers. in Taiwan has offered significant benefits to suffe Chapter Meeting welcomes all With this in mind, the 2013 IFSO-Asia Pacific state-of-the-a rt diagnosis and experts from all over the world to Taiwan to share and meta bolism. In addition to the treatment of all issues related to obesity, bariatric, ress has arranged an IFSO Cross Keynote Speech and the Parallel sessions, the Cong ons in order to create a more Strait Session, Live Surgery Demos, and Video Sessi practical and multi-disciplinary discussion. delegates and network in the Moreover, this is a rare opportunity to gather all ience the vibrant and buzzing energy phenomenal city of Kaohsiung, where you can exper are marked in your calendar! With of Southern Taiwan. Make sure that the dates meeting you in Kaohsiung, Taiwan, in open arms and warm regards, we look forward to April 2013. Sincerely yours, Prof. Pradeep Chowbey President of IFSO-Asia Pacific Chapter olic and Bariatric Surgery and IFSO APC President elect Prof. Wei-Jei Lee President of Taiwan Society for Metab Dr. Chih-Kun Huang President of 2013 IFSO-Asia Pacific Chapter Meeting Congress Alberic Fiennes named as incoming IFSO-EC president Alberic Fiennes has been named as the next president of the European chapter of IFSO, the International Federation for the Surgery of Obesity and Metabolic Disorders. Fiennes, who is currently president of BOMSS, the British Obesity and Metabolic Surgery Society, will lead IFSO-EC from 2014. He currently practices as in London and at St Anthony’s Hospital in Surrey. “I am honored to be following Professor Yuri Yashkov as the next President of IFSO-EC,” said Fiennes of his appointment. “Tackling obesity is complex and challenging. Patients who are severely overweight have a disease that may spoil every aspect of their lives. “They need safe and correct professional care plus understanding, kindness and support – to be helped, not judged. IFSO is playing a key role in improving that care and I look forward to contributing to its development.” BOMSS Council member and consultant bariatric surgeon Sally Norton said: “We are very proud that our current president will soon be leading the development and regulation of metabolic and weight loss surgery across Europe.” The International Federation for the Surgery of Obesity and Metabolic Disorders is a federation of national societies for surgeons and allied health professionals who treat patients with severe and complex obesity. Worldwide, the Federation is divided into four Chapters, and is made up of 40 official member associations as well as individual members from countries currently without a national society. Fiennes was formerly director of bariatric surgery at University College London Hospital. Prior to this, he had been associated with pioneers of British obesity surgery in the 1980s at St George's Hospital and Medical School in south-west London. Later, as consultant surgeon and senior lecturer, he went on to build up the current multi-disciplinary service there. BARIATRIC NEWS 23 ISSUE 13 | AUGUST 2012 Desk workers use as much energy as hunter-gatherers The Hadza tribe's daily energy expenditure questions our assumptions about exercise and weight. Photos: hadzafund.org/Brian Wood, flickr.com/Phillie Casablanca The cause of the obesity epidemic, says conventional wisdom, isn’t complicated: we eat too much, of the wrong things, and we don’t do enough exercise afterwards. However, research by a group of anthropologists on an African hunter-gatherer tribe suggests that it might be even simpler than that. An article, “Hunter-Gatherer Energetics and Human Obesity”, published in PLOS One (PLoS ONE. 2012 7(7):e40503.), has challenged that the common view that the widespread adoption of machines, cars, and desks has led to abnormally low calorie expenditure in Westerners, and that this has been a primary cause of obesity in developed nations. The study found that the Hadza tribe, who live a similar lifestyle to our Pleistocene ancestors, burn a similar amount of energy per day to sedentary Western workers, despite engaging in significantly more physical activity. The finding led the study’s lead investigator, Dr Herman Pontzer, of Hunter College, New York, to hypothesise that energy expenditure may be a relatively stable, constrained physiological trait, influenced more by genetics than by an individual’s environment and lifestyle. “There’s certain set points that humans have adapted to as a species, and we think that energy expenditure is one of those set points,” said Pontzer. “Nobody would argue with the idea that unhealthy weight gain happens when energy intake exceeds energy expenditure. That’s physics. The question is, which side of this equation is more important? Our data suggest it’s food intake which is causing these big differences in levels of obesity.” The paper is the first to directly study the energy expenditure of hunter-gatherer tribes. It challenges assumptions made by previous studies, which have attempted to estimate their energy expenditure by measuring their activity levels. The findings came as a surprise to Pontzer and his team. “We kind of expected those estimates to be borne out,” he said. “We had no reason to think otherwise.” Study The investigators studied 13 men and 17 women aged 18-75 from the Tanzanian Hadza tribe. The men of the tribe hunt game and gather honey, while women gather plant foods, using tools similar to tribes from the Pleistocene era. They live highly active lifestyles, the women walking on average 5.8km/day and the men 11.4 km/day. Around a third of their diet consists of meat, with the rest made up of honey, berries, tubers, and vegetables. They eat no processed food. Their energy expenditure was measured through the doubly-labelled water method, in which participants are given water marked with uncommon isotopes of hydrogen and oxygen. The amount of the marked water used in the creation of carbon dioxide during respiration can be calculated by measuring the concentration of the isotopes in urine samples. This rate of respiration was compared with measurements taken from Western workers, as well as figures from previous studies investigating agricultural and market economies across the world. As expected, the Hadza group were very lean, with body fat percentages on the low end of the ordinary healthy range among Western populations. However, when they measured their total energy expenditure, they found that it was “statistically indistinguishable” from Westerners. Performing multivariate comparisons of total energy expenditure controlling for fat free mass and age, the researchers found that Hadza women’s energy expenditure was similar to that of Western women and Hadza men’s total energy expenditure was similar to Western men; lifestyle had no effect on total energy expenditure. Exercise Pontzer emphasised that his findings did not diminish the importance of exercise to a healthy lifestyle. “These are snapshots of habitual energy use in two populations living a normal daily lifestyle,” he said. “After your body’s adapted to a certain lifestyle, you can throw a new exercise regime into that, and that might end up changing your energy expenditure at least for the short term until your body adjusts again.” The Hadza tribe had minimal levels of heart disease, diabetes, and other cardiovascular diseases, leading Pontzer to hypothesise that physical activity might be a part of keeping illness at bay. “Activity is probably still really important,” he said. “But not for obesity.” The Hadza The team lived with the Hadza tribe for two months to perform their study, although some in the group have been working with the tribe for almost a decade. “You can’t parachute in,” said Pontzer. “If someone came into your living room and said hey, would you mind giving me a urine sample and wear this GPS for the next couple of weeks, you’d tell them to go jump in a lake.” In the future, Pontzer hopes to be able to put their work on energy expenditure and diet into a larger context, including measuring the Hadza’s health over their lifespan: the study population, he said, was too small to measure possible subtle effects of age on energy expenditure. As well as providing research data, Pontzer also hopes that further study will be beneficial to the Hadza. He has set up a site, Hadza Fund, with his colleague Brian Wood, to promote responsible tourism in the Hadza homeland and raise awareness of their culture. 24 BARIATRIC NEWS ISSUE 13 | AUGUST 2012 Evaluating the benefits and risks of obesity drugs The processes used to evaluate pharmaceutical interventions to treat obesity could be transformed, according to a new report published by The George Washington University School of Public Health and Health Services. The Obesity Drug Outcome Measures report outlines a series of new approaches that should be considered by the FDA when evaluating the benefits and risks of obesity drugs. The Obesity Drugs Outcome Measures Dialogue Group was composed of a panel of experts and diverse stakeholders who identified the key issues surrounding the evaluation of obesity drugs. “At a time when so many Americans suffer with obesity and are faced with limited treatment options, there has been a rising call to review the emerging science on obesity to update the framework used when evaluating obesity drugs,” said Dr Christine Ferguson, Professor in the Department of Health Policy. “The FDA, under a re-authorised Prescription Drug User Fee Act, is likely to take a wider, more comprehensive look at how drugs developed to treat obesity affect how individuals with obesity feel and function. This report may help update the risk-benefit framework.” The report, which explored why the development and approval of obesity drugs have proven so difficult, makes several recommendations including: nObesity affects everyone differently – evaluating the benefits and risks of interventions should reflect the various considerations within the different categories of obesity based on feeling, functioning and health impairments. nObesity drugs may provide an additional option for helping individuals who do not respond, or inadequately respond, to other interventions. n Potential pharmaceutical interventions should be reviewed as obesity treatments rather than weight loss agents and should be limited to only those for whom they are medically appropriate. nThe benefit-risk evaluation of treatment with obesity drugs should extend beyond numerical weight loss to improvement in feeling and functioning. In the last month, the FDA has approved two obesity drugs (Belviq and Qsymia), on Developing Products for Weight Management does not explicitly include consideration of more symptomatic impairments in patient feeling and functioning, so companies do not tend to provide data on how a proposed obesity drug affects these types of health conditions. Subsequently, the FDA is unable to consider drug-specific improvements in these additional feeling and functioning domains when making approval decisions. The report also states that the FDA is not just concerned with efficacy and tolerability of drugs; the overall impact on health status must be considered in judging the benefits of an obesity medication, not just the medication's impact on weight alone. Therefore, under a reauthorised Prescription Drug User Fee Act, the FDA is likely to take a wider, more encompassing look at how drugs developed to treat obesity affect how individuals with obesity feel and function. Moreover, the agency will include patient-centred outcomes in its risk-benefit framework for evaluating these drugs. the first such approvals in more than a decade. However, this raises the question of why the development and approval of pharmacological interventions for treating obesity have proven so difficult. According to the report, the approval new obesity drugs has been limited due to concerns over drug safety, medically inappropriate use and the overall benefits of obesity drugs – 5-10% weight loss demonstrated on average in clinical studies. The FDA According to the report, clinicians and patients have repeatedly called for additional treatment options to be used in conjunction with lifestyle interventions, including pharmacotherapy. When considering new weight loss drugs, the FDA follows the draft 2007 Guidance for Industry on Developing Products for Weight Management and considers the recommendations of experts that sit on its Endrocrinologic and Metabolic Drugs Advisory Committee. Under the current Guidance for Weight Management Products, the FDA evaluates drugs intended for the clinical treatment of obesity based primarily on percentage of weight lost and changes in cardiometabolic factors such as blood pressure and lipid levels. However, the Guidance for Industry Findings The report also made several recommendations with regards to the approaches obesity as a disease and post market surveillance of pharmaceutical interventions: nDrugs under investigation for the clinical treatment of obesity should be reviewed as obesity treatments rather than weight loss agents. nCurrent clinical treatment options for obesity are limited, and obesity drugs may provide an additional intervention for helping individuals who do not respond, or inadequately respond, to other treatment interventions. nThe benefit-risk evaluation of treatment with obesity drugs should extend beyond numerical weight loss to improvement in feeling and functioning. Drug development and review should more adequately capture and consider how obesity drugs affect how individuals feel and function on a daily basis. nObesity is not a homogenous condition. The evaluation of the benefits and risks of pharmacologic intervention should reflect the different considerations within different categories based on feeling, functioning, and health impairments of obesity. n Use of obesity treatments should be limited to those for whom they are medically appropriate. Obesity drugs, like all drugs, come with side effects and risks. This requires responsible use and promotion and may require limiting access to obesity drugs to those individuals most likely to benefit due to their significant weight-related impairment in health, feeling, and functioning. Conclusions The authors concluded that the current FDA framework does not adequately categorise which types of patients with obesity could achieve benefits in feeling, function, and health risk. In addition, it stated that the agency does not adequately capture the many potential benefits of weight loss (short-term symptomatic, longer-term comorbidities or effects on quality of life) that may be improved through modest weight loss, aided by pharmacologic treatment. As a result, the report claims a more comprehensive patient-centred approach in making risk-benefit determinations could help the FDA ensure that safe and effective obesity drugs are available to both adult and paediatric patient groups for whom the benefits of improved physical and mental health and quality of life outweigh the risks associated with a particular drug. The report was supported by unrestricted gifts from Eisai, Novo Nordisk Worldwide, Obesity Action Coalition, Orexigen Therapeutics, Takeda Pharmaceuticals, the FDA and Vivus. The report can be downloaded from: http://sphhs.gwu.edu/releases/ obesitydrugmeasures.pdf Study suggests bariatric fracture fears unfounded given period) was comparable between the group of bariatric surgery patients and the group of matched controls. Up to three months post-operation, the rate of fractures for bariatric surgery patients was 1.01%, compared to 0.76% for the control. At 13-24 months, the rate had fallen to 0.80% compared to 0.79%; between 25-60 months, the figures were at 0.59% and 0.83%. The investigators stated that they did not observe an increase in overall risk for any fracture (8.8 vs 8.2 per 1,000 person years; adjusted relative risk 0.89, 95% confidence interval 0.60 to 1.33), osteoporotic fractures (0.67, 0.34 to 1.32), or non-osteoporotic fractures (0.90, 0.56 to 1.45). They noted that the patients in their study had a modestly increased risk of fracture over the first three months, which reduced over the next few years before trending towards an increased risk after three to five years; however, there was no statistical significance to the trend (figure 1, below). The study found that bariatric surgery patients who had used anti-anxiety agents in the previous six months, had a history of cerebrovascular disease or a previous fracture had a raised risk of fracture. The researchers observed an increased risk of fracture with greater reduction of excess BMI after surgery, but did not find a statistically significant trend. The study co-authors were Arief Lalmohamed, Frank de Vries, Marloes T Bazelier, Alun Cooper, Tjeerd-Pieter van Staa, Cyrus Cooper, and Nicholas C Harvey. 2.5 Adjusted relative risk for any fracture Bariatric patients do not face an increased risk of bone fracture in the first two years after their operation, according to a new study published in the British Medical Journal. The study, “Risk of fracture after bariatric surgery in the United Kingdom: population based, retrospective cohort study”, examined the outcomes of 2,079 UK bariatric operations, and did not find an increased number of bone fractures compared to a cohort of 10,442 people who had not undergone bariatric surgery. However, the study did not rule out the possibility of an increased risk of fracture beyond the period investigated. The finding comes despite the fact that bariatric surgery has been shown to negatively affect bone remodelling, leading to a loss in bone density. Study co-author Nicholas Harvey, honorary consultant rheumatologist at Southampton General Hospital, said “Overall, for the first few post-operative years, these results are reassuring for patients undergoing bariatric surgery, but do not exclude a more protracted adverse influence on skeletal health.” The authors say that the study is the first to investigate fracture risk in patients who underwent bariatric surgery versus matched controls. Study results The study looked at records of 2,079 patients with a BMI of at least 30 from the United Kingdom General Practice Research Database, and matched them to 10,442 control cases who did not have bariatric surgery. The mean follow-up time was 2.2 years. The investigators found that the rate of fractures (calculated as the number of fractures divided by the number of person years in a Bariatric surgery 95% CI Relative risk 1.0 2.0 1.5 1.0 0.5 0 0 1 2 3 4 5 Years since bariatric surgery Patients at risk: Bariatric surgery 2,079 Matched controls 10,442 1,916 9,733 1,393 7,255 888 4,717 6 7 170 1,003 Figure 1: Spline regression plot of time since bariatric surgery and risk of any fracture in bariatric surgery patients versus matched controls. Risk adjusted for confounders. Source: “Risk of fracture after bariatric surgery in the United Kingdom: population based, retrospective cohort study” BARIATRIC NEWS 25 ISSUE 13 | AUGUST 2012 FastStitch tool will help surgeons by making the closure process simpler and safer John Hopkins University FastStitch: the future of suture? Device could assist in reducing complications and costs Undergraduates from Johns Hop- kins University, MD, have developed a disposable suturing tool to guide the placement of stitches and guard against the accidental puncture of internal organs. Suture-related complications following abdominal surgery can results in infection, herniation and evisceration, all of which require additional treatment and in some cases, re-operation. In addition, the financial cost of treating herniation alone is estimated to be some US$2.5 billion (follow-up treatment and medical malpractice expenses). This new device, called FastStitch, is described as a cross between a pliers and a hole-puncher. The device was created as part of a a biomedical engiFastStitch suturing device neering course assignment for eight Johns Hopkins students over the past school year. They were asked to design and test a tool that that would improve the because it would feel familiar to surgeons and team. “Then, as you close the arms, the springway surgeons stitch together the fascia. require less training. loaded clamp is strong enough to punch the needle “Doctors who have to suture the fascial layer “The fascial layer is placed between the top through the fascial layer. When this happens, the say it can be like pushing a needle needle moves from one arm of the through the leather of your shoe,” tool to the other.” said team member Luis Hererra, a The device also features a “This device allows the surgeon to bring the sophomore biomedical engineering visual guide to help ensure that muscle layers back together evenly, safely and major from Downey, DA. “If the the stitches are placed evenly, needle accidentally cuts into the located the proper distance away quickly, and this can lead to better outcomes and bowel, it can lead to a sepsis infecfrom the incision and apart from fewer complications.” tion that can be very dangerous.” one another. The students believe To help prevent this, the students this will also reduce postoperative designed the FastStitch needle to complications. remain housed within the jaws of the stitching and bottom arms of the device,” said Sohail The prototype was constructed mostly of ABS tool. The hand-size pliers-like shape was chosen Zahid, of Morris Plains, NJ, leader of the student plastic, so that the instrument can be inexpensive and discarded after one use. “Just about every major operation in the chest and abdomen requires a large cut to be made through the muscle layers,” said Dr Hien Nguyen, an assistant professor of surgery in the Johns Hopkins School of Medicine, served as the students' clinical advisor during the development of FastStitch. “If these layers are not brought back together evenly, complications can occur. This device allows the surgeon to bring the muscle layers back together evenly, safely and quickly, and this can lead to better outcomes and fewer complications.” The students have formed a Baltimore-based company, Archon Medical Technologies, to conduct further research and development of FastStitch. The company is being supported by grant funding and by most of the prize money won in the student invention and business plan contests earlier this year. Animal testing of the device is under way, and further testing with human cadavers is expected to begin later in 2012. Although the device is still in the prototype stage, the FastStitch team has already received recognition and raised more than US$80,000 this year in grant and prize money to move their project forward. Among their wins were first-place finishes in University of California, Irvine, and University of Maryland business plan competitions and in the ASME International Innovation Showcase. In addition to Zahid and Herrera, the other students who have participated in the FastStitch project are Andy Tu, Daniel Peng, Stephen Van Kootyen, Leslie Myint, Anvesh Annadanam and Haley Huang. Through the Johns Hopkins Technology Transfer office, the team members have obtained preliminary patent protection for their invention. All eight students are listed as co-inventors, along with Nguyen and Johns Hopkins graduate student Adam Clark. 26 BARIATRIC NEWS ISSUE 13 | AUGUST 2012 Controlled diet can aid CaOx supersaturation following bariatric surgery Researchers report that urinary CaOx supersaturation decreased significantly According to a study by researchers from the Mayo Clinic in Rochester, MN, bariatric patients who prescribe to a diet that is normal in calcium, low in oxalate and moderate in protein, can improve urinary calcium oxalate (CaOx) supersaturation, but not urinary oxalate excretion, in patients with a history of kidney stones. The study is published in the journal Urology (Lieske et al, , August 2012;80;2;250-254). The aim of the study was to identify the effect of a controlled metabolic diet on reducing urinary CaOx supersaturation in subjects with hyperoxaluric nephrolithiasis after potentially malabsorptive forms of bariatric surgery. Using data from nine patients with a history of CaOx kidney stones and mild hyperoxaluria who underwent bariatric surgery, Dr Ran Pang, and colleagues investigated the effect of a controlled metabolic diet on reducing urinary CaOx supersaturation. Baseline 24-hour urine samples were collected while participants consumed a free choice diet. Before two final 24-hour urine collections, participants were then instructed to consume a controlled diet low in oxalate (70 to 80 mg/day), normal in calcium (1,000 mg/day), and moderate in protein before two final 24-hour urine collections The researchers found that urinary CaOx supersaturation decreased significantly, from 1.97 ± 0.49 delta Gibbs (DG) with the free choice diet to 1.13 ± 0.75 DG with the controlled diet. This decrease occurred without a significant alteration in urinary oxalate excretion (0.69 ± 0.29 mmol/day with the free choice diet versus 0.66 ± 0.38 mmol/day with the controlled diet). The change in CaOx supersaturation was partially due to non-significant increases (p>0.05) in urinary volume, citrate and pH. The researchers concluded that a restriction of dietary oxalate alone might not be enough to reduce urinary oxalate excretion to normal levels in this group of patients, with known enteric hyperoxaluria. However, they warmed that additional strategies could be necessary, such as the use of oral calcium supplements as oxalate binders and a lower fat diet. “The results of the present study suggest that a diet, normal in calcium and moderate in protein, can improve urinary CaOx supersaturation in patients after bariatric surgery,” the authors noted. “However, such a balanced low-oxalate diet did not normalise urinary oxalate excretion by itself.” Bariatric surgery patients have clinically significant sleep apnoea The majority of bariatric surgery patients have clinically significant obstructive sleep apnoea (OSA) but report fewer symptoms than other sleep disorders patients, according to a study published in the August 2012 issue of the journal Sleep and Breathing. “Patients with obstructive sleep apnoea frequently complain of sleepiness during the daytime, loss of motivation and interest in activities, as well as poor concentration and memory recall,” said lead author, Dr Katherine M Sharkey, department of medicine, division of pulmonary, critical care and sleep medicine at Rhode Island Hospital, and University Medicine. “The aim of this study was to evaluate associations between OSA severity and self-reported sleepiness and daytime functioning in patients considering bariatric surgery.” The study identified 269 patients (239 women) who had who had overnight polysomnography and completed the Epworth Sleepiness Scale (ESS) and the Functional Outcomes of Sleep Questionnaire (FOSQ) prior to bariatric surgery. The mean age of the patients was 42.0 ± 9.5 years and the mean BMI 50.2 ± 7.72. The patient’s OSA was classified as none/mild (apnoea-hypopnea index (AHI) <15), moderate (AHI 15-30) or severe (AHI≥30). The researchers then calculated the proportion of unique variance for the five FOSQ subscales. Analysis of variance was used to determine if ESS and FOSQ were associated with OSA severity and unpaired t tests compared ESS and FOSQ scores in the study sample with published data. Results The outcomes revealed that the average AHI was 29.5 ± 31.5 events per hour (range = 0–175.8), the mean ESS score was 6.3 ± 4.8, and the mean global FOSQ score was 100.3 ± 18.2. The proportion of unique variances for FOSQ subscales showed moderate-to-high unique contributions to FOSQ variance, whilst ESS and global FOSQ score did not differ by AHI group. One hundred and twelve patients were classified with none/mild AHI, 77 patients with moderate AHI and 80 patients with severe AHI. Therefore, 58.3% of patients had moderate or severe OSA that had not been diagnosed prior to the patients' evaluation in anticipation of bariatric surgery. Although subjective sleepiness and functional impairment were not associated significantly with OSA severity, the researchers found that the vast majority of patients considering bariatric surgery for treatment of obesity have clinically significant OSA. Despite the high prevalence of sleep apnoea, this sample of patients reported less sleepiness and daytime impairment than previously reported studies. “These patients also report fewer symptoms and may be attributing daytime napping and decreased functioning to something other than a sleep disorder.” Sharkey warned that patients with severe obesity need evaluation for OSA as they underreport symptoms and self-report measures are not an adequate substitute for objective assessment and clinical judgment when evaluating bariatric patients for OSA. “The lack of symptoms of sleep apnoea in this population means that we must be even more vigilant in identifying sleep apnoea prior to bariatric surgery in order to reduce the risk of complications,” she added. “Further research is needed to understand individual differences in sleepiness in patients with OSA.” The study was supported by internal funding. Addition researchers involved in the study were Drs Richard P Millman, G Dean Roye, David Harrington and Christine Tosi, as well as Dr Henry J Orff, University of California at San Diego. BARIATRIC NEWS 27 ISSUE 13 | AUGUST 2012 New drug sensitises leptin leading to weight loss A2bAR plays key role in obesity A drug compound that increases Researchers from Boston sensitivity to the hormone leptin, thereby suppressing appetite, could have implications for the development of new treatments for obesity in humans. The study was published in the journal Cell Metabolism. “By sensitising the body to naturally occurring leptin, the new drug could not only promote weight loss, but also help maintain it,” said senior study author George Kunos of the National Institute on Alcohol Abuse and Alcoholism. “This finding bodes well for the development of a new class of compounds for the treatment of obesity and its metabolic consequences.” Although leptin is an appetite suppressant, leptin supplements alone have not been effective at reducing body weight in humans. It is believed that the human body becomes desensitised to the hormone over time, lessening its response. Researchers do not know why desensitisation occurs; however, it has been hypothesised that cannabinoid receptors, which mediate the feelings of hunger produced by cannabis and naturally occurring cannabinoids in the body, are involved in the process. In this study, investigators tested a new compound, JD5037, which targets cannabinoid receptor type 1 (CB1R) without penetrating the brain. They report that not only did JD5037 suppress the appetite of obese mice leading to weight loss, it also improved metabolic health. Appetite and weight reduction caused by JD5037 are mediated by resensitising mice to endogenous leptin through reversing the hyperleptinemia by decreasing leptin expression and secretion by adipocytes, and increasing leptin clearance via the kidney. Importantly, the mice did not show signs of anxiety or other behavioural side effects. Previously, researchers have concentrated on blocking these receptors believing it could be more effective at long-term weight loss and developed anti-obesity drugs that target CB1R. However, only one CB1R-binding drug (rimonabant) was sold in Europe beginning in 2006 and it was taken off the market a few years later due to serious psychiatric side effects, including anxiety, depression and thoughts of suicide. In order to reduce these sideeffects, Kunos and his team developed a CB1R-targeting drug that did not enter the brain as easily as rimonabant. However, the drug was not as effective at reducing weight and improving metabolic health, possibly because of its specific mode of action. “This study shows that inverse agonism at peripheral CB1R not only improves cardiometabolic risk in obesity but has anti-obesity effects by reversing leptin resistance,” said Kunos. “Obesity is a growing public health problem, and there is a strong need for new types of medications to treat obesity and its serous metabolic complications, including diabetes and fatty liver disease.” University School of Medicine have reported that the A2b-type adenosine receptor (A2bAR) plays a significant role in the regulation of high fat, high cholesterol diet-induced symptoms of type 2 diabetes. The study is published online in PLoS ONE (2012 7(7):e40584). “High fat diet and its induced changes in glucose homeostasis, inflammation and obesity continue to be an epidemic in developed countries,” said study lead Dr Katya Ravid, professor of medicine and biochemistry and director of the Evans Center for Interdisciplinary Biomedical Research at BUSM. “This study indicates that the pharmacologic activation of A2bAR demonstrated its newly identified role in signalling down to regulate the levels of IRS-2, which then improved the signs of high fat diet-induced type 2 diabetes.” Study A2bAR is a naturally occurring protein receptor found in the cell membrane and is activated by adenosine. The role it plays in regulating inflammation is also associated with type 2 diabetes and obesity. To examine the association of A2bAR activation with a diet high in fat and cholesterol, the researchers experimented with mice that lacked A2bAR and compared the results with a control group. The administration of high fat, high cholesterol diet (HFD) for sixteen weeks vastly upregulated the expression of the A2bAR in control mice, while the mice lacking A2bAR under this diet developed greater obesity, compared with matching control mice. Katya Ravid The signs also indicated the hallmarks of type 2 diabetes demonstrated by elevated blood glucose levels and increased insulin levels. When the control group was given the same diet, however, the levels of A2bAR increased, resulting in decreased insulin and glucose levels and obesity. A link also was identified between the expression of A2bAR, insulin receptor substrate 2 (IRS-2) and insulin signalling. The results showed that the level of IRS-2, a protein that has previously been shown to mediate the effect of insulin, was impaired in tissues of the experimental model lacking A2bAR, causing higher concentrations of blood glucose. When A2bAR was activated in the control group using a pharmacologic agent with a diet high in fat and cholesterol, the level of IRS-2 was increased, lowering blood glucose. To correlate these results in humans, the researchers then examined fat tissue samples from obese individuals. The results showed that A2bAR expression is high in fat from obese individuals, marked by inflammation, compared with lean individuals, and is strongly correlated with IRS-2 expression. “Our study suggests the important role of A2bAR in maintaining the level of IRS-2, a regulator of glucose and insulin homeostasis,” concluded Ravid. “The outcome could be potentially significant in identifying therapies for obesity and type 2 diabetes.” The co-authors of the study included Hillary Johnston-Cox, Dr Milka Koupenova-Zamor, Dr Noyan Gokce and Dr Melissa Farb. 28 BARIATRIC NEWS ISSUE 13 | AUGUST 2012 Obesity vaccine moves a step closer The results of a new obesity vaccine that promotes weight loss have been reported by investigators from Braasch Biotech. The article, “Effects of novel vaccines on weight loss in diet-inducedobese (DIO) mice”, to be published in the Journal of Animal Science and Biotechnology, the researchers assessed the effectiveness of two somatostatin vaccinations, JH17 and JH18, in reducing weight gain and increasing weight loss in mice. Prior to the start of the study, male C57BL/6J mice were fed a 60% Kcal fat diet for eight weeks. They were then vaccinated, via the intraperitoneal route, with two formulations (JH17 & JH18) of chimeric-somatostatin vaccines at one and 22 days of the study. Control mice were injected with phosphatebuffered saline (PBS). All mice were fed 60% Kcal fat diet for the remainder of the study. The researchers measured the body weights two times a week and food intake was measured weekly. At week six, mice were euthanized, a terminal bleed was made and antibody levels to somatostatin and levels of insulin-like growth factor 1 (IGF-1) were determined. Outcomes The investigators reported that vaccination with both vaccine formulations induced a statistically significant body weight change over the study period, as compared with PBS controls. Percentage of baseline body weight was also significantly affected by vaccination during the study period. Vaccinates finished the study at 104% and 107% of baseline weight, JH17 & JH18 respectively, while untreated controls reached 115% of baseline weight. Food intake per mouse was similar in all mouse groups during the entire study. Control mice did not demonstrate any antibody titers to somatostatin, while all vaccinated mice had measurable antibody responses (>1:500,000 titer). IGF1 levels were not statistically significant among the groups, but were elevated in the JH18 vaccinates (mean 440.4ng/ mL), compared with PBS controls (mean 365.6ng/mL). Vaccination with either JH17 or JH18 chimeric -somatostatin vaccines produced a statistically significant weight loss as compared with PBS controls (p<0.0001), even though the diet-induced-obese mice were continually fed a 60% Kcal fat diet. “This study demonstrates the possibility of treating obesity with vaccination,” said Dr Keith Haffer, President and CSO of Braasch Biotech. “Although further studies are necessary to discover the long term implications of these vaccines, treatment of human obesity with vaccination would provide physicians with a drug- and surgical- free option against the weight epidemic.” The company said the next stage could see obese dogs and pigs tested with the experimental vaccine. UK hospital becomes IFSO centre of excellence The South East Weight Loss Surgical Centre in Orpington, Kent, has become the second hospital in the UK to be recognised as an IFSO Centre of Excellence in Bariatric and Metabolic Surgery. The surgical centre, which is located at the private BMI Chelsfield Park Hospital in the south east of England, achieved the accreditation after the centre and its surgical team, led by consultant bariatric surgeon Shamsi El-Hasani, satisfied the International Federation for the Surgery of Obesity’s Centre of Excellence requirements. “This accreditation highlights the expertise, experience and dedication of my team to the care of our patients.” Mr Shamsi El-Hasani, consultant bariatric surgeon These requirements include demonstration of a surgeon’s experience and aptitude, a sufficient caseload, appropriate follow-up, an available multidisciplinary team, and suitable equipment and resources. “This accreditation highlights the expertise, experience and dedication of my team to the care of our patients,” said Mr Shamsi El-Hasani. “We hope that this accreditation will lend support, both to the South East Weight Loss Surgical Centre and BMI Chelsfield Park Hospital, but also to the field of bariatric surgery itself.” “Deciding when and where to have surgery can be a difficult choice but this recognition will place BMI Chelsfield Park Hospital on the map as a centre of excellence in the UK and internationally.” In order to achieve the accreditation, the hospital had to make an investment in equipment and furniture designed for bariatric patients. They also had to demonstrate concern for the patients’ dignity while providing care and support to its bariatric patients. “Meeting the IFSO accreditation criteria demonstrates our commitment to the highest standards in bariatric patient care,” said hospital executive director Ruth Hoadley. “At BMI Chelsfield Park Hospital we believe that all our patients deserve access to the highest standards of care backed by the highest standards of medical expertise.” “Many obese patients can feel isolated or anxious but our team aim to support them at every stage of their journey to ensure their decision to undergo surgery has a positive impact on their health, confidence and outward appearance.” European Centres of Excellence There are currently 20 IFSO-accredited centres of excellence across Europe. Before the South East Weight Loss Surgical Centre’s accreditation, the only other centre of excellence in the UK was the Spire Manchester Hospital. Spain and Greece lead the rest of Europe in terms of centres of excellence, with five and four centres holding the accreditation respectively. The programme was created by IFSO in order to create a gold standard for bariatric centres, judged by the creation of guidelines that could define surgeon's credentials, as well as institutional requirements for safe and efficient management of morbidly obese and patients with metabolic disorders. Before a centre can be accepted into the programme, the surgeon must requirements including: n appropriate certification, n training and experience to perform general, gastrointestinal and bariatric surgery, n testimonials by mentors as to the surgeon’s ability, n a caseload of 25 procedures per year (or 50 cases where adjustable gastric banding is the most common procedure), n the ability to perform revisional surgery, n and involvement in the training of other surgeons. Among other requirements, the institution must: n ensure that surgeons performing bariatric surgery have relevant training and experience, n have consultants in cardiology, pulmonology, psychiatry and recovery available, n have a recovery room, n have radiology department facilities, n have a blood bank and blood testing facilities, n have a complete line of necessary equipment, n have a written informed consent process, n have a digital database of all treatments and outcomes n and have a caseload of at least 50 surgical cases per year including revisional cases The full requirements can be found on the European Accreditation Council for Bariatric Surgery’s website. They were outlined in the May 2008 issue of Obesity Surgery (Obes Surg. 2008 18(5):497-500). BARIATRIC NEWS 29 ISSUE 13 | AUGUST 2012 Product and Industry news FDA approves two obesity drugs The FDA has approved two obesity drugs within the past two months, the first drugs to be approved for the condition in over a decade. Belviq (lorcaserin hydrochloride), marketed in the US by Eisai and manufactured in Switzerland by Arena Pharmaceuticals, is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. “Obesity threatens the overall well-being of patients and is a major public health concern,” said Dr Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition.” Belviq is indicated to be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of: n BMI>30 or greater or n BMI>27 or greater in the presence of at least one weight related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes) Clinical programme The Belviq Phase 3 clinical trial programme consisted of three double-blind, randomised, placebo-controlled trials: BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus). All three trials included a standardized program of diet, moderate exercise and behavioural counselling for both the placebo and Belviq groups. BLOOM evaluated Belviq versus placebo over a two-year treatment period in 3,182 non-diabetic, obese adult patients (18 to 65 years old) with or without comorbid conditions and non-diabetic, overweight adult patients with at least one weight related comorbid condition. BLOSSOM evaluated Belviq versus placebo over a one-year treatment period in 4,008 non-diabetic, obese adult patients (18 to 65 years old) with or without comorbid conditions and non-diabetic, overweight adult patients with at least one weight related comorbid condition. BLOOM-DM evaluated Belviq versus placebo over a one-year treatment period in 604 obese and overweight adult patients (18 to 65 years old) with type 2 diabetes who were receiving oral antihyperglycemic agents. The outcomes showed that Belviq along with diet and exercise was more effective than diet and exercise alone at helping patients lose 5% or more of their body weight after one year and managing the weight loss for up to two years. The most common adverse reactions for patients without diabetes treated with Belviq were treatment with placebo. Approximately 62% and 69% of patients lost at least 5% of their body weight with the recommended dose and highest dose of Qsymia, respectively, compared with about 20% of patients treated with placebo. Patients who did not lose at least 3% of their body weight by week 12 of treatment with Qsymia were unlikely to achieve and sustain weight loss with continued treatment at this dose. Therefore, response to therapy with the recommended daily dose of Qsymia should be evaluated by 12 weeks to determine, based on the amount of weight loss, whether to discontinue Qsymia or increase to the higher dose. If after 12 weeks on the higher dose of Qsymia, a patient does not lose at least 5% of body weight, then Qsymia should be discontinued, as these paAbove: Qsymia is the first FDA-approved once-daily combination treatment for patients struggling with obesity tients are unlikely to achieve clinically meaningful Below: Belviq is believed to decrease food consumption and promote satiety weight loss with continued treatment. headache, dizziness, fatigue, nausea, dry mouth, and constipation. In patients with diabetes, the most common adverse reactions were hypoglycemia, headache, back pain, cough, and fatigue. Post-marketing studies As part of the approval procedure for Belviq, the companies committed to conduct post-marketing studies to assess the safety and efficacy of Belviq for weight management in obese pediatric patients, as well as to evaluate the effect of long-term treatment with Belviq on the incidence of major adverse cardiovascular events in overweight and obese subjects with cardiovascular disease or multiple cardiovascular risk factors. The cardiovascular outcomes trial will include echocardiographic assessments. The FDA has recommended that Belviq be classified as a scheduled drug. The DEA will review the FDA's recommendation and determine the final scheduling designation. Once the DEA has provided the final scheduling designation, Eisai will announce when Belviq will be available to patients and physicians in the United States. Qsymia The FDA also approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie diet and exercise for chronic weight management. “Qsymia is the first FDA-approved once-daily combination treatment for patients struggling with obesity,” said Peter Tam, president of Vivus. “The degree and severity of obesity and the lack of effective pharmacological interventions that we face as a society were two primary reasons for the development of Qsymia.” The drug is approved for use in adults with a BMI>30 or adults with a BMI>27 who have at least one weight-related condition such as hypertension, type 2 diabetes or dyslipidemia. Vivus expects to launch the drug by the fourth quarter of 2012. Qsymia is a combination of two FDA-approved drugs, phentermine and topiramate, in an extended-release formulation. Phentermine is indicated for short-term weight loss in overweight or obese adults who are exercising and eating a reduced calorie diet. Topiramate is indicated to treat certain types of seizures in people who have epilepsy and to prevent migraine headaches. “Obesity threatens the overall well being of patients and is a major public health concern,” said Dr Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weightrelated comorbid condition.” The safety and efficacy of Qsymia were evaluated in two randomised, placebo-controlled trials that included approximately 3,700 obese and overweight patients with and without significant weight-related conditions treated for one year. All patients received lifestyle modification that consisted of a reduced calorie diet and regular physical activity. The recommended daily dose of Qsymia contains 7.5mg of phentermine and 46mg of topiramate extended-release. Qsymia is also available at a higher dose (15mg phentermine and 92mg of topiramate extended-release) for select patients. Results from the two trials show that after one year of treatment with the recommended and highest daily dose of Qsymia, patients had an average weight loss of 6.7% and 8.9%, respectively, over Pathway Genomics signs agreement with DASA Pathway Genomics, a San metabolism and exercise response, preDiego-based genetic testing laboratory, has signed an agreement with Brazilian company Diagnósticos da América (DASA), the largest private medical diagnostics company in Latin America. The agreement will bring Pathway’s reporting system to physicians in Brazil. The Pathway system generates genetic reports from saliva samples, addressing a variety of medical issues including an individual’s carrier status for recessive genetic conditions, food scription drug response, and propensity to develop certain diseases such as heart disease, type 2 diabetes and cancer. “Pathway’s vision is to responsibly reveal personalised and actionable genetic information in order to globally educate, inform and improve health and well-being,” said Dr Michael Nova, Pathway’s chief medical officer. “Our alignment with DASA is a major part of this vision, and we are excited to help bring this scientifically-advanced The FDA noted that Qsymia must not: n be used in patients with glaucoma or hyperthyroidism n be used in patients with recent (within the last six months) or unstable heart disease or stroke n be used during pregnancy because it can cause harm to a foetus (exposed to topiramate, in the first trimester of pregnancy has an increased risk of oral clefts), females of reproductive potential must not be pregnant when starting Qsymia therapy or become pregnant while taking Qsymia. The Agency also recommended: n females of reproductive potential should have a negative pregnancy test before starting Qsymia and every month while using the drug and should use effective contraception consistently while taking Qsymia. n regular monitoring of heart rate for all patients taking Qsymia, especially when starting Qsymia or increasing the dose. The most common side effects of Qsymia are paresthesia, dizziness, altered taste sensation, insomnia, constipation and dry mouth. The FDA approved Qsymia with a Risk Evaluation and Mitigation Strategy (REMS) which consists of a Medication Guide advising patients about important safety information and elements to assure safe use that include prescriber training and pharmacy certification. The purpose of the REMS is to educate prescribers and their patients about the increased risk of birth defects associated with first trimester exposure to Qsymia, the need for pregnancy prevention, and the need to discontinue therapy if pregnancy occurs. Qsymia will only be dispensed through specially certified pharmacies. Vivus will be required to conduct ten postmarketing requirements, including a long-term cardiovascular outcomes trial to assess the effect of Qsymia on the risk for major adverse cardiac events such as heart attack and stroke. Laurie Traetow, executive director of the American Society of Bariatric Physicians said, “Obesity medicine specialists are excited about the FDA adding another tool to the obesity treatment toolbox, which for so many years had been virtually barren in the pharmacotherapy area.” new cardiac panel was developed with input from cardiology centers. The genetic test claims technology to the people of Brazil.” to offer physicians insight into Pathway’s multiple genetic tests, how a patient’s genes may affect includes: heart-related conditions, includn Pathway Fit, which addresses a ing various drug responses and patient’s food metabolism and genetic risk for developing certain exercise response. The test has cardiovascular diseases. recently shown positive results “The partnership between DASA and with a clinical trial by California Pathway represents a milestone in Schools VEBA, in which, 179 Brazilian medicine, ensuring access employees showed significant to predictive genetic tests through an weight loss success compared to advanced and innovative technology,” controls. said Dr Octávio Fernandes, DASA’s nCardiac Health Insight, Pathway’s chief operating officer. “With 50 years of expertise, the company has one of the largest medical teams in Latin America, composed of nearly 2,000 world-renowned doctors, and offering more than 3,000 types of laboratory tests and imaging diagnostics provided by more than 18,000 professionals.” Pathway’s laboratory is accredited by the College of American Pathologists (CAP) and accredited in accordance with the US Health and Human Services’ Clinical Laboratory Improvement Amendments (CLIA) of 1988. Pathway is also a member of the American Clinical Laboratory Association (ACLA). 30 BARIATRIC NEWS ISSUE 13 | AUGUST 2012 Product News Covidien launches world’s first knotless suture reload device Covidien has released the V-Loc knotless to suture inside the body, according to a recent duced the occurrence of malformed staples in five pre-clinical study (Omotosho et al J Laparoendosc Adv Surg Tech A. 2011 21(10):893-7). Compared with conventional suturing, the proprietary Endo Stitch suturing device can save 4570% of laparoscopic suturing time clinical studies show (Nguyen et al, Surg. Res. 2000 93(1):133-6, J Am Assoc Gynecol Laparosc. 1996 3(2):299303, Urology. 1995 46(2):242-5, Pattaras et al, J Endourol. 2001 15(2):187-92). “Covidien works closely with surgeons to develop devices that not only improve patient outcomes, but also make surgery easier, safer and more efficient. We believe that our new V-Loc knotless suturing reloads for minimally invasive surgery will help surgeons perform aspects of their procedures with greater efficiency,” said Paul Hermes, Vice President, Chief Technology OfEndo GIA Radial Reload with Tri-Staple Technology ficer, Covidien Surgical Solutions. “Covidien is committed to the advancement of bariatric surgery technology and offers a full portfolio of products and services to support bariatric surgeons, University Medical Center. “As an early user of their practices and patients.” the Endo Stitch device with the V-Loc reload, I’ve been able to perform laparoscopic suturing with Endo GIA Black reload greater ease and efficiency than I previously could Separately at the meeting, an investigahave using traditional devices that require knots.” tional team led by Dwight Bronson, Manager, Research and Development, Covidien, presented V-Loc device a poster titled, “Comparison of EndoStapler According to the company, combining proprietary Performance in Challenging Tissue Applications,” automated needle-passing technology with a knot- (ASMBS Abstract No. P-178) co-authored by Coless suturing device, the V-Loc device for Endo vidien researchers Elizabeth Contini and Jennifer Stitch and SILS Stitch devices offers distinctive Whiffen. benefits over hand suturing and conventional Their work demonstrated that the Covidien automated suturing options. Endo GIA Black reload with Tri-Staple technolThe V-Loc device for use with Endo Stitch has ogy, which deploys three rows of graduated height a unique barb and loop design, enabling faster staples on either side of a transection, exhibited suturing by eliminating the need to tie any knots significantly better “B”-shaped staple formation and saving surgeons 35-42% of the time required (p<0.001) for all regions of the stomach and resuturing device, the world’s first knotless suture reload for laparoscopic and single-incision procedures. The V-Loc is a reload that works with the company’s proprietary Endo Stitch and SILS Stitch suturing devices for multi-port and single-port laparoscopic surgery. The new device can increase operating room efficiency during bariatric surgery and other procedures, the company claims. “The ability to suture internal tissue laparoscopically without the need to tie knots can help surgeons shorten one of the most labour-intensive tasks performed during bariatric surgery,” Dr Dana D Portenier, assistant professor of surgery, Duke of the seven regions, compared with a competitive thick tissue reload which deploys three rows of single height staples (Staple formation comparison between Covidien's EGIA60AXT and Ethicon's ECR60G in an ex-vivo tissue model, Covidien Engineering Report No. PCG-006_rev1, January 24, 2012 (data on file)). The “B”-shaped staple, widely considered the gold standard for staple formation, ensures staple line security and allows blood flow through the tissue, both of which are important factors in promoting post-surgical healing. Endo Stich barb and loop Educational initiative In addition, the company a new bariatric patient education and practice management initiative, ‘Shaping a Better Future in Bariatric Surgery program’. A key objective of this initiative is to seamlessly support bariatric practices in their efforts to build clinically effective relationships with their patients, such as arming prospective patients with useful information to guide treatment decisions when exploring bariatric surgery as an option for weight loss. Spider Surgical System makes Indian debut TransEnterix single-incision Spider Surgical System has been used in the Asian-Pacific Region for the first time. Dr Michel Gagner, who was attending the symposium and surgical workshop at the Max Institute of Minimal Access, Metabolic & Bariatric Surgery at Max Super Specialty Hospital in New Delhi, performed four sleeve gastrectomies using the system. He explained that the Spider platform allows surgeons to exercise advanced minimally invasive techniques while preserving the triangulation capacity they expect during laparoscopic procedures. The Spider System allows surgeons to introduce a camera and multiple instruments into the patient’s abdomen by way of a single incision made in the naval. With a circumference of approximately 18 mm, the company claims the system delivers the smallest singlesite incision in the market. Using the system, a surgeon makes one small incision and inserts the platform and expands it like an umbrella. Expansion offers true-left and true-right coordination between the video camera monitor and the surgeon’s hands, and allows the surgeon to approach the operating site at the necessary angles. Through the platform’s two rigid ports, the surgeon inserts a camera and a wide variety of off-the-shelf laparoscopic tools. Through its two flexible ports, the surgeon inserts TransEnterix’s 360-degree flexible instruments. “The flexible instruments allow a surgeon to achieve angles and visualize critical anatomy without requiring as many incisions as traditional laparoscopy,” said the symposium’s director, Dr Pradeep Chowbey. “The result may be fewer incisions and a fast recovery for the patient, while providing surgeons with enhanced capabilities.” The Indian procedures come a month after the system was used for the first time in the UK. The procedure was performed by Gagner at Homerton University Hospital, in London. New generation of Harmonic ACE+ shears approved for US sale Ethicon Endo-Surgery's new Harmonic ACE+ shears have received FDA 510(k) clearance, allowing the company to market the device in the USA. The new shears are a development of the existing Harmonic group of ultrasonic surgical devices, intended for multiple surgical jobs including dissection, sealing, transection, and otomy creation. Ethicon claim that the device's “Adaptive Tissue Technology" responds intelligently to varying tissue conditions by regulating energy delivery and providing surgeons with enhanced audible feedback, exhibiting 23% less thermal spread and delivering 21% shorter transection times compared with the previous generation of Harmonic Ace shears. The device's blade has also been redesigned with multifunctionality, precise grasping and dissection in mind. “I like how the Adaptive Tissue Technology senses and responds with improved energy delivery and the generator tone changes,” said Paul Kemmeter, bariatric surgeon at Grand Health Partners, Michigan and consultant for Ethicon Endo-Surgery. “It makes me feel very comfortable knowing that the optimal amount of energy will be delivered consistently each time. Ethicon say that since the introduction of the line in 1992, Harmonic product have been used in more than 14 million surgical procedures around the world. “With the introduction of Adaptive Tissue Technology, the Harmonic Ace+ Shears elevate the precision of the Harmonic portfolio," said Tom O’Brien, Ethicon Endo-Surgery vice president, global strategic marketing. “Based on surgeon feedback, Ethicon EndoSurgery will continue to advance the performance and precision of Harmonic devices through better energy management and refined design. We will also ensure our products make clinical and economic sense to all of our customers." Be Heard. Send your press releases to Bariatric News or add us to your press list [email protected] BARIATRIC NEWS 31 ISSUE 13 | AUGUST 2012 Calendar of events 2012-13 September 11-15 October 22–23 XVII IFSO World Congress New Delhi, India www.ifsoindia2012.org September 20-24 Obesity 2012 Charleston, United States http://bariatricsummit.com/ Frankfurt, Germany www.frankfurter-meeting.de 13th Minimally Invasive Surgery Symposium 2013 October 24-28 October 1-5 European Association for the Study of Diabetes Frankfurt, Germany www.frankfurter-meeting.de/ 7th Frankfurter Meeting Taunton, United Kingdom www.aquaconferencemanagement.co.uk/ soba/soba-2012 Halifax, Nova Scotia, Canada http://interprofessional.ubc.ca/obesity/ 9th Annual Bariatric Summit 2012 7th Frankfurter Meeting SOBA 2012 The 4th Conference on Recent Advances in the prevention and Management of Childhood and Adolescent Obesity September 22–24 October 22–23 March 6–9 October 24-26 San Antonio, Texas www.obesity.org Berlin, Germany www.easd.org November 22-23 62nd Obesity & Associated Conditions Symposium Orlando, FL. www.asbp.org October 26–28 3rd Annual Fall Educational Event Las Vegas, United States http://fall.asmbs.org/ November 29–December 01 9th Congreso Internacional B.E.S.T 2012 Guadalajara, Mexico www.bestcongress2012.com/ December 6-8 4th Annual Intnational Congress for Sleeve Gastrectomy New York City www.icssg.com 2013 January 23-25 4th BOMSS Annual Meeting Glasgow, UK www.bomss.org.uk Las Vegas, United States www.miss-cme.org April 10–13 2013 IFSO Asia-Pacific Chapter Meeting Kaohsiung , Taiwan www.ifso.com/Index. aspx?id=ChapterMeetings April 26-27 3rd International Symposium on non-invasive bariatric techniques Lyon, France www.noninva-obesity.com May 12-15 European Congress on Obesity Liverpool, UK www.eco2013.org May 21–24 V IFSO Latin American Congress of Bariatric and Metabolic Surgery To list your meeting details here, please email: [email protected] Cusco, Peru www.ifsocusco2013.com/ The next issue of Bariatric News is out in December Editorial deadline: 20 November 2012 Advertising deadline: 20 November 2012 If you are interested in submitting an article for the newspaper, please contact: [email protected] If you are interested in advertising in Bariatric News, please contact: [email protected] If you would like to submit press release, please email: [email protected] EDITORIAL BOARD Henry Buchwald BARIATRIC NEWS Managing Editor Owen Haskins Simon Dexter [email protected] John Dixon News editor MAL Fobi [email protected] Ariel Ortiz Lagardere Peter Myall Designer Peter Williams [email protected] Publisher Dendrite Clinical Systems 10 Floor, CI Tower St George’s Square, High Street New Malden, Surrey KT3 4TE – UK Tel: +44 (0) 20 8494 8999 Managing Director Peter Walton [email protected] Printed by CPL Associates 2012 Copyright ©: Dendrite Clinical Systems Ltd. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, transmitted in any form or by any other means, electronic, mechanical, photocopying, recording or otherwise without prior permission in writing of the Managing Editor. The views, comments and opinions expressed within are not necessarily those of Dendrite Clinical Systems or the Editorial Board. Advert Ethicon Endo-Surgery EthiconECHELON Endo-Surgery Powered FLEX™ ENDOPATH® Stapler Powered ECHELON FLEX™ ENDOPATH® Stapler Compression with Stability. Power with Control. Compression with Stability. Power with Control. Ethicon Endo-Surgery, a division of Johnson & Johnson Medical Ltd Pinewood Campus, Nine Mile Ride, Wokingham, Berkshire RG40 3EW www.ees.com Ethicon Endo-Surgery, a division of Johnson & Johnson Medical Ltd Pinewood Campus, Nine Mile Ride, Wokingham, Berkshire RG40 3EW www.ees.com ©2012 Ethicon Endo-Surgery, a division of Johnson & Johnson Medical Ltd. All Rights Reserved. For complete product details see instructions for use. ©2012 Ethicon Endo-Surgery, a division of Johnson & Johnson Medical Ltd. All Rights Reserved. For complete product details see instructions for use.