Bariatric surgery prevents cardiovascular events
Transcription
Bariatric surgery prevents cardiovascular events
B ISSUE 10 | January 2012 ARIATRIC NEWS A snapshot of THE NEWSPAPER DEDICATED TO THE TREATMENT OF OBESITY FOR THE HEALTHCARE PROFESSIONAL IN THIS ISSUE... Jacqueline Jacques discusses the nutritional deficiencies in obese and postoperative patients. Patients who undergo gastric bypass surgery are less likely to die from cardiovascular events than people who receive more conventional treatment for their weight condition, according to the latest results from the Swedish Obese Subjects (SOS) study. The research was recently published in the Journal of the American Medical Association Source (Sjostrom et al. JAMA 2012; 307: 56-65). 4 ASMBS updates SG position statement The Association has updated its position on sleeve gastrectomy. 6 Coffee Time We talk to Professor Philip James about his achievements and the battle against the obesity pandemic. The Halo effect 11 IFSO 2011 14 EBT white paper A joint TaskForce has released a white paper on endoscopic bariatric therapies “Bariatric surgery was associated with about a 30% reduction in the incidence of both heart attacks and strokes,” said researcher Professor Lars Sjostrom, University of Gothenburg, Sweden. “While pre-surgery BMI did not predict surgical health outcomes, having diabetes or risk factors for diabetes was a strong indicator of surgical benefit. This could have implications for selecting candidates for weight loss surgery.” Swedish Obese Subjects The SOS study is an on-going, non-randomised, prospective, controlled study conducted at 25 public surgical departments and 480 primary health care centres in Sweden, and includes 2,010 obese participants who underwent bariatric surgery and 2,037 matched obese controls who received usual care (control group). The research is testing the hypothesis that bariatric surgery is associated with a reduced incidence of cardiovascular events and examining the relationship between weight change and cardiovascular events. Patients were recruited between September 1987 and January 2001. The date of analysis was December 2009, with median follow-up of 14.7 years. Inclusion 7 A report from the 2011 IFSO meeting in Hamburg, Germany. Bariatric surgery prevents cardiovascular events Vector Created by: Matt Ward/Echo Enduring Media - www.echoenduring.com (c) 2009; Distributed under the Creative Commons lisence. Nutrition According to research, family members of patients who have undergone bariatric surgery have reported weight loss and improvements in their lifestyles. pages 12–13 18 Product news 20 News in Brief 21 Calendar of events 22 criteria were age 37 to 60 years and a body mass index of at least 34 in men and at least 38 in women. Surgery patients underwent gastric bypass (13.2 per cent), banding (18.7 per cent), or vertical banded gastroplasty (68.1 per cent), and controls received usual care in the Swedish primary health care system. Physical and biochemical examinations and database cross-checks were undertaken at pre-planned intervals. The average changes in body weight after 2, 10,15, and 20 years were 23 per cent, 17 per cent, 16 per cent, and 18 per cent in the surgery group and 0 per cent, 1 per cent, 1 per cent, and 1 per cent in the control group, respectively. Continued on page 3 Complications and costs of bariatric surgery According to two recently published papers in the British Journal of Surgery (October 2011; 98 [10]), long-term complications and further surgery are not uncommon, but despite these disadvantages surgery is a more costeffective way of tackling rising morbid obesity rates than non-operative care. The first paper entitled, ‘Man- agement of late postoperative complications of bariatric surgery’ (Hamdan et al.) examined the increasing number of patients presenting to non-specialist units with complications following bariatric procedures and outlined the management of the most common late post- operative complications that are likely to present to the general surgeon. “In England, there are more than 30,000 deaths a year attributed to obesity alone, taking an average of nine years off a person's normal life expectancy,” said the lead author of the paper, consultant surgeon Mr Khaled Hamdan, Di- gestive Diseases Unit at Brighton and Sussex University Hospitals. “As a result of the current, largely ineffective, non-surgical options for treating obesity, the past decade has witnessed an exponential increase in the number of bariatric operations performed.” Therefore, the researchers undertook a literature search for late postoperative complications after bariatric surgery using PubMed, Embase, OVID and Google search engines, and combinations of the terms bariatric surgery, gastric bypass, gastric banding or sleeve gastrectomy, and late or delayed complications. Only studies with follow-up longer than six months were included. Complications The most common long-term complications after gastric banding include band slippage (which affects 15% to 20% of patients) and erosion (which can affect up to 4% of patients). Following gastric bypass, complications such as internal hernia (5% to 10%), adhesions and anastomotic stenosis were found to be common causes of intestinal obstruction. Megaoesophagus (dilation of the esophagus), a rare but well reported late complication occurs in one in every 200 patients after LAGB and hepatobiliary complications were another particular challenge, the researchers noted. The study found that functional disContinued on page 4 The newspaper for the healthcare professional dedicated to the treatment of obesity Advert Bariatric News is a quarterly publication covering the latest developments in obesity management and technology, and is distributed at major international meetings across the globe. Read by more than 1,500 bariatric healthcare specialists, the publication is the ONLY newspaper that delivers accurate, high-quality information covering all aspects of bariatric surgery, pharmacology, obesity-related illnesses, nutrition, and much more. For your FREE SUBSCRIPTION to the leading Bariatric newspaper email [email protected]. BARIATRIC NEWS 3 ISSUE 10 | January 2012 Surgery reduces events Continued from page 1 Mortality During follow-up, there were 49 cardiovascular deaths among the patients in the control group and 28 cardiovascular deaths among the patients in the surgery group (adjusted hazard ratio [HR], 0.47; 95% CI, 0.760.29; p=0.002). In total (fatal and non-fatal), there were 234 cardiovascular events among patients in the control group and 199 cardiovascular events among patients in the surgery group adjusted HR, 0.67; 95% CI, 0.54-0.83; p<0.001). After adjustment for a number of variables, bariatric surgery was associated with a reduced number of fatal cardiovascular deaths and a lower incidence of total cardiovascular events. Bariatric surgery was associated with reduced number of fatal heart attack deaths (22 in the surgery group vs. 37 in the control group), with analysis indicating that bariatric surgery was related both to reduced fatal heart attack incidence and total heart attack incidence. Also, bariatric surgery was associated both with reduced number of fatal stroke events and total stroke events. Interestingly, the researchers found no significant rela- tionship between weight change and cardiovascular events in the surgery or control group. They suggest that the lack of association between weight loss and reduction of cardiovascular events could be related to inadequate statistical power to detect this relationship. “Alternatively, following relatively modest weight loss induced by bariatric surgery, there is no further risk reduction attributable to greater, subsequent weight loss,” the authors note. “Our negative findings also emphasise the need to explore weight loss independent of effects of bariatric surgery." “In conclusion, this is the first prospective, controlled intervention to our knowledge reporting that bariatric surgery is associated with reduced incidence of cardiovascular deaths and cardiovascular events. These results - together with our previously reported associations between bariatric surgery and favourable outcomes regarding long-term changes of body weight, cardiovascular risk factors, quality of life, diabetes, cancer, and mortality demonstrate that there are many benefits to bariatric surgery and that some of these benefits are independent of the degree of the surgically induced weight loss." Editorial In an accompanying editorial in JAMA (2012; 307 8889), Dr Edward H Livingstone, University of Texas Southwestern Medical Center, Dallas, argues that the benefits from bariatric surgery are not related to weight loss, the main reason these operations are performed. He also adds that the absolute difference in cardiovascular events and deaths between the surgery and non-surgery groups in these latest SOS data was small. “Obese patients who are otherwise healthy should not have bariatric surgery, because the expected health benefits do not necessarily exceed the risks of weight-loss operations,” he concludes. “People with abdominal obesity may be at higher risk for heart problems than people with higher fat mass in the trunk and legs. It may be time for experts to reconsider the criteria for recommending bariatric surgery and to rigorously assess the available evidence and provide updated recommendations for bariatric procedures for the treatment of obesity.” Target surgical outcome depends on disease severity The optimum bariatric operation depends on the disease severity and the type of outcome that best suits patients with type 2 diabetes mellitus (T2DM), according to research published online in the October 2011 issue of the Annals of Surgery. The study, conducted by investigators at the University of Minnesota in Minneapolis, concluded that after one year of follow-up, Roux-en-Y gastric bypass (RYGB) was superior to non-surgical controls (NSC) and laparoscopic adjustable gastric band surgery (LAGB) with respect to weight loss and improvement in diabetes. “This study provides an important perspective about the comparative efficacy of LAGB, duodenal switch (DS), and NSC to the RYGB for treatment of T2DM among obese patients,” said lead author Dr Robert B Dorman. “We concluded that if the endpoint is to improve HbA1c, then the DS is the superior operation compared to the RYGB for patients with a high BMI.” Although it is known that RYGB resolves T2DM in a high proportion of patients and is considered the standard operation for T2DM resolution in morbidly obese patients, no data exists comparing the efficacy of medical management and other bariatric operations to the RYGB for treatment of T2DM in comparable patient populations. Study design As a result, investigators designed the study to compare the relative efficacy of medical management, DS, and LAGB to RYGB for treatment of T2DM. They performed a retrospective case-matched study of 86 morbidly obese patients with T2DM who had undergone medical management (nonsurgical controls [NSC]; n=29), LAGB (n=30), or DS (n=27) and were compared with matched T2DM patients who had undergone RYGB. Matching was performed with respect to age, sex, body mass index, and hemoglobin A1C (HbA1C). Outcomes assessed were changes in body mass index, HbA1C, and diabetes medication scores at one year. Results At one year, RYGB produced the greater weight loss, HbA1C normalisation, and medication score reduction compared to both NSC and LAGBmatched cohorts. However, DS led to significantly greater improvements in HbA1c and diabetes medication scores and a higher rate of diabetes resolution (81.5% vs 48.1%; p=0.02), despite no greater weight loss at one year. Complication rates at one year were 10% for LAGB, 15.1% for RYGB, and 40.7% for duodenal switch. One-year readmission rates were 6.7% for LAGB, 11.6% for RYGB, and 14.8% for duodenal switch. There were no deaths. According to the researchers, RYGB should remain the gold standard for treatment of severe or greater obesity in the setting of type 2 diabetes, as the procedure has better outcomes than both medical management and the laparoscopic banding. However, they added that for super-obese patients (BMI> 50kg/m2), the duodenal switch should be considered, although only performed by experienced surgeons and centres. Message from the editor Welcome to the first edition of Bariatric News of 2012 and I would like to take this opportunity to wish you all the very best for 2012! This month’s cover article features the latest data from the Swedish Obesity Study. Our second cover story highlights two studies from the British Journal of Surgery that highlight the complications and cost effectiveness associated with bariatric surgery. In this issue’s ‘Coffee Time’ section we are pleased to feature an interview with Professor Philip James, a world-renowned campaigner of obesity awareness and current President of the IASO. Following the recent XVI IFSO meeting in Hamburg, we report the highlights from the meeting, We also feature a subsequent report from International Bariatric Club. In this issue we also feature a position statement update on sleeve gastrectomy from the ASMBS, as well as a white paper joint published by the ASMBS and ASGE on endoscopic bariatric therapies. The 'Snapshot' feature in this edition highlights Canada, and a new report describing rates of obesity and those most at risk. There is also news from SOBA (the UK's bariatric anaesthetist organisation), and BAPRAS (a UK plastic surgery group), who are calling for body contouring guidelines. There are also a study from Canada that recommends a new scoring system for predicting risk from bariatric surgery. As ever, we also report the latest product news If you would like to contact the editor, please email: [email protected] Subscribe to Bariatric News for FREE A subscription to Bariatric News is free of charge and you can receive a printed copy and/or electronic copy delivered to your home, hospital, company or email. Please send an email to communications@e-dendrite. com stating your full postal address (for a printed copy). Alternatively, please visit our website and complete the online subscription form. Subscribe online: www.e-dendrite.com/publishing/bariatric-news 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. and clinical trial updates, as well as quick look at the latest news in our 'News in Brief' section. We hope you find this issue an interesting and informative read. If you would like to comment on any of the articles or have an article suggestion please do not hesitate to contact us. Owen Haskins, Editor 4 BARIATRIC NEWS ISSUE 10 | January 2012 Obesity: A state of malnutrition? Jacqueline Jacques, ND Obesity is commonly referred to in textbooks of nutrition and medicine as “over-nutrition.” It is easy, even for trained physicians, to look at a severely obese patient and assume that an excess of stored calories must mean an excess of (or at least adequate) vitamins and minerals. However, the more study we do in this area, the more we see quite a different picture emerge. Obesity places great physiologic strain on the human body – and that strain takes a toll on many systems including on nutritional status. Studies increasingly demonstrate significant defi- ciencies in many nutrients in those suffering from morbid obesity. These include, but are not limited to Vitamin E1, Vitamin A and the Carotenoids2, Zinc3, Selenium3 and Thiamine4. The most recent data from the Third National Health and Nutrition Examination Survey (NHANES III: 1988–1994) showed that higher BMI was associated with deficiency of vitamins, A, E, C, D, selenium, folate and carotenoids.5 Vitamin D deficiency is so common in morbid obesity that it should most likely be considered a comorbidity.6 Despite emerging research, we have still limited knowledge of the true nutritional status of obese individuals. Most industrialized countries general- ly favour calorie-dense, nutrient-poor diets that supply less than the recommended amounts of many vitamins and minerals. We have growing reason to believe that obesity and some of its common co-morbid conditions like diabetes create greater nutritional demands on the body, perhaps contributing to deficiency. Thus, individuals with obesity may have nutritional requirements that are over and above the normals on which the recommended intakes are based. Limited studies that have looked at overall nutritional status in obese populations have demonstrated that this is likely to be true,7 but more data is needed to determine what nutritional challenges are a direct result of obesity, versus those that may correlate with other factors such as age or economic status. Why is this important? Good nutritional status is a marker for good health. When patients are preparing for a major surgical procedure, their nutritional status may have an impact on both short and long-term outcomes. Good nutritional status is important for Complications and costs of bariatric surgery Continued from page 1 orders such as reflux and dumping, and nutritional deficiencies are common and should be differentiated from conditions that require urgent investigations and timely surgical intervention. Up to one-third of patients experience intermittent gastrointestinal disturbances, particularly if they do not adhere to the dietary advice and nutritional supplements they are given after surgery. Between 13% and 36% of patients develop cholesterol gallstones after surgery, due to rapid weight loss, but only 10% develop symptoms requiring surgical intervention. Less than 5% to 10% of patients have chronic problems with dumping syndrome, which can cause facial flushing, light-headedness and diarrhoea after eating carbohydrate-rich meals. Most patients find that reducing their intake of carbohydrates and avoiding drinking liquids half an hour before and after eating improves their symptoms. The authors note that complications after bariatric surgery should be thoroughly assessed and investigated. They highlight the fact that a patient's symptoms may not necessarily relate to their gastric surgery and stress that the attending surgeon should be familiar with bariatric procedures and gastrointestinal alterations following surgery. “Managing these patients can be challenging for a non-bariatric surgeon and timely liaison with a bariatric unit is advisable,” the authors emphasized. “In addition, functional problems affecting the gastrointestinal tract may pose a diagnostic conundrum, requiring specialist intervention and liaison with specialists in the field when necessary to spare patients unnecessary surgical interventions.” The researchers stressed that long-term complications should be taken into consideration when deciding what type of surgery to undertake. Cost-effectiveness The second paper entitled ‘Cost-utility of bariatric surgery for morbid obesity in Finland’ (Mäklin et al) from the Finnish Office for Health Technology Assessment reported that bariatric surgery is more cost-effective as it increases health-related quality of life and reduces the need for further treatment, and total healthcare costs among patients who are very obese. “Our study compared bariatric surgery with the current practice in treating morbid obesity in Finland, which is ordinary treatment ranging from intensive conservative treatment to brief advice from a doctor to lose weight,” said Ms Suvi Mäklin, lead author. “This was evaluated using data on healthcare resource use in patients with a body mass index of 35 kg/m2 or more from a large representative population survey.” The study evaluated the cost–utility of the following bariatric surgery procedures – gastric bypass, sleeve gastrectomy and gastric banding – compared with ordinary treatment. Mäklin explained that an analysis was performed from a healthcare provider's perspective using a combination of a decision tree and a Markov model, with a time horizon of ten years. Health-related quality of life was estimated from a representative population survey, and other parameter values were based on registers, systematic reviews, controlled studies and expert opinion. The results showed that in the base-case analysis, bariatric surgery was more effective and less costly than the ordinary treatment. The mean costs of treating an obese patient with bariatric surgery in Finland was €33,870 compared with €50,495 for non-operative treatment. These cost savings are due to reductions in other health conditions after surgery. The research team also reported that bariatric surgery also increased the number of quality-adjusted life 7.63 vs. 7.05, for bariatric surgery and ordinary treatment, respectively, during the ten-year time frame they studied. Uncertainty around the parameter values was tested comprehensively in sensitivity analyses, and the results were robust, said the researchers. “Surgery for morbid obesity improves health-related quality of life and reduces the need for further treatments and total healthcare costs,” the researchers concluded. “The present results suggest that, compared with surgical treatment, non-operative care will on average be more costly for the Finnish healthcare system five years after surgery.” normal wound healing, immunity and recovery times, and some of the specific nutrients that have been shown to be impaired in obesity, are directly correlated with these outcomes8-12. Following bariatric surgery, the early weeks and months present patients with varying degrees challenges to nutrient intake, which may be complicated by episodes of vomiting and dumping. Moreover, risk for nutrient deficiencies continues to increase over time in patients with malabsorptive procedures such as gastric bypass. Increasing our understanding of pre-operative nutrition may lead not only to better patient health and improved recovery, but also to predictive models of who may be at greatest risk for early onset of post-operative nutritional deficiencies. This kind of information could eventually help to answer questions about why some patients develop acute nutritional problems, while others remain deficient. Finally, healthier patients with better outcomes are good for the entire bariatric surgery community. The more that can be done to assure patient health, the more successful everyone is. References: 1. Ohrvall M, Tengblad S, Vessby B. Lower tocopherol serum levels in subjects with abdominal adiposity. J Intern Med 1993;234:53±60. 2. Pereira S, Saboya C, Chaves G, et al. Class III Obesity and its Relationship with the Nutritional Status of Vitamin A in Pre- and Postoperative Gastric Bypass. Obes Surg. 2008 Apr 8. [Epub ahead of print] 3. Madan AK, Orth WS, Tichansky DS, et al. Vitamin and trace mineral levels after lap§ohill BC, et al. Associations between body mass index and the prevalence of low micronutrient levels among US adults. MedGenMed. 2006 Dec 19;8(4):59. 6. Wortsman J, Matsuoka LY, Chen TC, et al. Decreased bioavailability of vitamin D in obesity. Am J Clin Nutr. 2000 Sep;72(3):690-3. 7. Ledikwe JH, Smiciklas-Wright H, Mitchell DC, Jensen GL, Friedmann JM, Still CD. Nutritional risk assessment and obesity in rural older adults: a sex difference. Am J Clin Nutr. 2003 Mar;77(3):551-8. 8. Swartz-Basile DA, Rubin DC, Levin MS. Vitamin A status modulates intestinal adaptation after partial small bowel resection. JPEN J Parenter Enteral Nutr 2000;24:81–8. 9. Thomas DR. Specific nutritional factors in wound healing. Adv Wound Care 1997;10:40–3 [review]. 10.Senapati A, Slavin BM, Thompson RPH. Zinc depletion and complications of surgery. Clinical Nutrition 1990;9:341–6. 11.Zunic J, Stavljenic-Rukavina A, Granic P, et al. Changes in vitamin E concentration after surgery and anesthesia. Coll Antropol 1997;21:327–34. 12.Thomas DR. Specific nutritional factors in wound healing. Adv Wound Care 1997;10:40–3 [review]. 6 BARIATRIC NEWS ISSUE 10 | January 2012 Mechanisms of action of the adjustable gastric band: Induction of satiety, not physical restriction Wendy A. Brown, Paul R. Burton, Paul E. O’Brien Centre for Obesity Research and Education, School of Public Health, Monash University Australia The laparoscopic adjustable gastric band (LAGB) is ideally placed on the cardia of the stomach, just below the oesophagogastric junction. In the past it was assumed that the presence of a band in this position caused a meal to accumulate in the pouch of stomach proximal to it, before gradually being released into the remainder of the gut. Thus, the band was thought to work by restricting the volume of food ingested to that able to be a e b f accommodated in the proximal pouch. This small volume of food was thought to stretch the stomach and cause early satiety. Gradual emptying of the proximal pouch into the infra-band stomach was though responsible for prolonged inter-meal satiation. Recent studies by our group, lead by Dr Paul Burton, confirm that mechanism of action of LAGB is the induction of early and prolonged satiety, however, the intraluminal events that lead to this are far more complex than simple retention of food in the proximal pouch. By combining high resolution video manometry1-4 with nuclear studies of c g d gastric emptying5, 6, we have demonstrated that the expected physiology of a LAGB at its optimal volume does not cause a food bolus to rest above the band in the proximal pouch. Rather, the bolus will transit across the band in stages over a period of 45-60 seconds due to 4-6 repeated contractions of the lower oesophagus. The infra-band stomach subsequently empties normally (figure 1)7. The increased activity of the lower oesophagus and upper stomach appears to be critical to the sensation of satiety achieved with a small meal. Animal studies modelling the human situation performed by Dr Brian Oldfield’s 8 group suggest that the vagus is an important mediator of this sensation, and the flow of food past an optimally activated band may be triggering these afferents. If a band is over-adjusted, or if patients engage in inappropriate eating behaviour, eating too quickly or too big a volume, food will accumulate within the proximal pouch. The patient will experi- ence significant adverse symptoms, including discomfort and regurgitation. These symptoms are caused by vigorous peristaltic contractions that hyper-pressurise the proximal pouch in an attempt to transit the bolus across the band. Over time, this increase in pressure can lead to pathological proximal pouch formation9. If a band is underfilled, there is no limitation to transit of food across the LAGB and therefore the proximal stomach and lower oesophagus are not stimulated. The patient will not be satiated a small meal and be able to eat bigger volumes. Unsurprisingly, weight loss is then difficult to achieve and maintain. Dr Burton’s work has helped us to understand the optimal intraluminal pressure milieu in the presence of a band (figure 2) 1. Ideally we would use these data to objectively calculate an optimal adjustment for an individual patient, but as yet we lack technology to permit this. Understanding how an AGB affects the intraluminal pressures and flow of 1. Distal oesophagus: Peristalsis High pressure – 100+ mmHg h 2. Lower Oesophigal Sphincter: Attenuated – 11mmHg Relaxation, then after-contraction 3. Proximal stomach: Sensory (the IGLEs) + tonic contraction Figure 1: Diagram depicting how a bolus of food transits across the band. The food is ingested and reaches the proximal pouch via primary peristalsis (a-b); a small amount of food transits the band and the remaining bolus refluxes back into the oesophagus before a contraction of the lower oesophagus pushes it back into the proximal pouch (c-e). The process is repeated until the bolus completely transits the band (f-g). 4. Gastric band optimally adjusted: Basal pressure 25-30 mmHg Figure 2: The correct position of a LAGB and optimal intraluminal pressure milieu food with eating has allowed us to improve our patient education. We work closely with our patients, explaining the critical importance of eating small volumes of food slowly. We also aim to adjust the band only to control hunger. We hope that this improved patient education along with better band adjustments will help improve our outcomes, both in terms of weight loss and complication rate. References: 1. Burton PR, Brown W, Laurie C, Richards M, Afkari S, Yap K, Korin A, Hebbard G, O'Brien PE. The effect of laparoscopic adjustable gastric bands on esophageal motility and the gastroesophageal junction: Analysis using high-resolution video manometry. Obes Surg. 2009;19:905-914 2. Burton PR, Brown WA, Laurie C, Richards M, Hebbard G, O'Brien PE. Effects of gastric band adjustments on intraluminal pressure. Obes Surg. 2009;19:1508-1514 3. Burton PR, Brown W, Laurie C, Lee M, Korin A, Anderson M, Hebbard G, O'Brien PE. Outcomes, satiety, and adverse upper gastrointestinal symptoms following laparoscopic adjustable gastric banding. Obes Surg. 2010 4. Burton PR, Brown WA, Laurie C, Hebbard G, O'Brien PE. Mechanisms of bolus clearance in patients with laparoscopic adjustable gastric bands. Obes Surg. 2010;20:1265-1272 5. Burton PR, Yap K, Brown WA, Laurie C, O'Donnell M, Hebbard G, Kalff V, O'Brien PE. Effects of adjustable gastric bands on gastric emptying, supra- and infraband transit and satiety: A randomized double-blind crossover trial using a new technique of band visualization. Obes Surg. 2010;20:1690-1697 6. Burton PR, Yap K, Brown WA, Laurie C, O'Donnell M, Hebbard G, Kalff V, O'Brien PE. Changes in satiety, supra- and infraband transit, and gastric emptying following laparoscopic adjustable gastric banding: A prospective follow-up study. Obes Surg. 2010 7. Burton PR, Brown WA. The mechanism of weight loss after laparoscopic adjustable gastric banding: Induction of satiety not restriction. International Journal of Obesity. 2011;35 8. Kampe J, Brown WA, Stefanidis A, Dixon JB, Oldfield B. A rodent model of adjustable gastric band surgeryimplications for the understanding of underlying mechanisms. Obesity Surgery. 2009;19:625-631 9. Burton PR, Brown WA, Laurie C, Korin A, Yap K, Richards M, Owens J, Crosthwaite G, Hebbard G, O'Brien PE. Pathophysiology of laparoscopic adjustable gastric bands: Analysis and classification using high-resolution video manometry and a stress barium protocol. Obes Surg. 2010;20:19-29 ASMBS update sleeve gastrectomy position statement The American Society for Metabolic and Bariatric Surgery (ASMBS) has published an updated position statement on the use of sleeve gastrectomy (SG). The position statement update was published as the Clinical Issues Committee and Executive Council have determined that since the 2009 position statement on SG was issued, there have been substantial changes to the published literature regarding the procedure and that the number and quality of the publications evaluating SG warrant publication of an updated statement. Following a review of published literature, the ASMBS concluded that there is now substantial comparative and long-term data demonstrating durable weight loss, improved medical comorbidities, long-term patient satisfaction, and improved quality of life after SG. The ASMBS therefore recognizes SG as an acceptable option as a primary bariatric procedure and as a first stage procedure in high risk patients as part of a planned staged approach. The position statement states that based on the current published literature, SG has a risk/benefit profile that lies between the laparoscopic adjustable gastric band and the laparoscopic Roux-en-Y gastric bypass. The recommendations of the 2009 position statement was based on a systematic literature review and reported overall mean percent excess weight loss (%EWL) after SG of 55% (average follow-up less than three years) and complication rates in large single cen- tre series (n>100) ranged up to 15%. The reported leak, bleeding, and stricture rates in the systematic review (which included high risk patients) were 2.2%, 1.2%, and 0.63%, respectively, and the post-operative 30-day mortality rate was 0.19% in the published literature. An updated search of the literature revealed 69 studies published since the last position statement, which provides relevant outcome data to support updated recommendations. This new literature includes several randomised controlled trials that generally show equivalence or superiority of the laparoscopic SG to currently accepted procedures (Roux-en-Y gastric bypass, RYGB, and laparoscopic adjustable gastric banding, LAGB) with short and medium-term follow-up periods. In addition to the randomized trials, there are several matched cohort, prospective and case control studies that demonstrate weight loss outcomes, diabetes remission rates, improvements in inflammatory markers and cardiovascular risk, and improvements in a variety of obesity-related comorbidities after SG that are equivalent to or exceed RYGB and LAGB procedures. Remission rates of type 2 diabetes after SG are typically reported between 60% and 80% depending on the patient population and length of follow-up. A systematic review of diabetes remission rates after SG included 27 studies and 673 patients. At a mean follow-up of 13 months, diabetes had resolved in 66% of patients and improved in 27%. There was a mean decrease in blood glucose of -88 mg/dL and a mean decrease in HbA1c of -1.7%. In addition to improvements in many clinical parameters, several studies have also demonstrated significant improvements in quality of life after SG. While there are several case control and retrospective series that have demonstrated superiority of RYGB over SG with regards to weight loss, comorbidity reduction, or diabetes remission, 39 randomised studies have demonstrated superiority or equality to RYGB and superiority of LSG over LAGB in terms of weight loss (EWL 66% vs 48%), comorbidity reduction, or diabetes remission. A review of published complications after SG demonstrates major complication rates that are equal to or less than those reported in the 2009 statement and no new safety concerns have emerged. Staple line leaks and bleeding after SG continue to be the most serious complications and occur in 1-3% of patients in large published series. The development of gastroesophageal reflux (GERD) after sleeve gastrectomy is reported in several publications, but a recent systematic review evaluating the effect of SG on GERD reported inconsistent outcomes. The statement confirms that further studies of the long-term effects of SG on GERD symptoms and the role of SG for patients with hiatal hernia are necessary in order to draw more definitive conclusions. There are also studies that report SG results in fewer nutritional deficiencies but the statement states that there is insufficient evidence to draw any definitive conclusions and more evidence is needed regarding the effect of SG on long-term vitamin, mineral, and nutritional deficiencies. Several large registries have also reported weight loss and complication data after SG. The American College of Surgeons Bariatric Surgery Center Network longitudinal database (n=28,616) recently reported 30-day, six-month, and one-year outcomes of LSG, LAGB, and RYGB including morbidity and mortality, readmissions, and reoperations as well as reduction in body mass index (BMI) and weight-related comorbidities. This study reported that the LSG has higher risk-adjusted morbidity, re- admission and reoperation /intervention rates compared to the LAGB, but lower reoperation/intervention rates compared to the LRYGB and open RYGB. There were no differences in mortality between groups. However, LSG patients had a higher BMI and higher risk profile than LAGB patients. Reduction in BMI and most of the weight related comorbidities after the LSG also lies between those of the LAGB and the RYGB. The Michigan Bariatric Surgery Collaborative (MBSC) evaluated 30 day complication rates for 62 bariatric surgeons in 25 hospitals and reported the risk of serious complication after LSG to be 2.2% compared to 0.9% for LAGB and 3.6% for RYGB. Another publication from MBSC used a registry of 25,469 bariatric patients to develop a risk prediction model for serious complications after bariatric surgery and found the risk of SG to fall between LAGB and RYGB. A large prospective national registry in Spain reported outcomes of 540 SG patients from 17 centres. Morbidity rate was 5.2% and mortality rate 0.36%. Complications were more common in super obese patients, males, and patients >55 years old. Mean percent excess BMI loss (EBL) was 72.4 +/- 31% at 24 months and Bougie caliber was an inverse predictive factor of %EBL at 12 and 24 months. In this patient population, diabetes remitted in 81% of the patients and hypertension improved in 63.2%. A second-stage surgery was performed in 18 patients (3.2%). BARIATRIC NEWS 7 ISSUE 10 | January 2012 Coffee time with Philip James The ‘Coffee Time’ segment in Bariatric News is dedicated to experts from national and international obesity, bariatric and metabolic societies. In this issue, we talk to Professor Philip James, co-founder of the International Obesity Task Force and current President of the International Association for the Study of Obesity... Why did you decide to enter Belsen or Auschwitz prisoners as medicine? he was Jewish, and this taught me I came from a small village in Wales where you could either become a teacher, a Minister of Religion, a solicitor or a doctor. All my family were teachers so I opted to become a medic. I went to the University College Hospital (London, UK) in the early 1960’s, where I studied science and then medicine. I told my boss at the time, Lord Rosenheim, that I thought that medicine was terrible, that doctors were using medieval approaches to their clinical problems and did not have a clue what was causing them. I said that I was leaving and commented that I may go abroad to do some research. He promptly arranged for me to get a job with the Medical Research Council in Jamaica! This position enabled me for the first time to learn about nutrition. At this stage I was a paediatrician dealing with gastroenterological problems, and I spent this part of my career developing new lumen tubes for measuring absorption. It was at this time I also helped generate the data for the glucose-saline treatment of children with diarrhoea, which has been hugely beneficial to countless children around the world. Who have been your greatest influences and why? Without question, the single greatest influence was, Lord Rosenheim. He was a brilliant doctor who worked incredibly hard. He was not pompous or filled with self-importance, he admitted immediately if he didn’t know anything and most importantly, he only believed in the very highest quality of work. He looked after many complicated patients, quite often they were former that you need to treat people exactly the same, but some people require sensitive care for special problems. All of these principles I still try to uphold everyday. What experience in your training has taught you the most valuable lesson? The first time I took charge of a clinical group in Cambridge establishing the MRC Dunn Clinical Nutrition Centre. It was at this time that I realised just how difficult it was to manage a group of doctors with different personalities, working on very diverse projects with distinctive demands and requirements. directing The Rowett Institute of Nutrition and Health at the time. So I arranged for my son to move house for us and agreed to meet Tony Blair in Inverness the following day. Within the hour I was being briefed by Alistair Campbell who wanted something on a Food Standards Agency that was ‘as straight as a die’, something that the public would trust. Two hours later I was Talking to the BBC, The Times, The Telegraph as well as appearing on Radio 4’s ‘Today’ programme the following morning. Needless to say, the whole thing blew up with hours. That was my most searing experience. Tell us about one of your most memorable career experiences? You helped to established the International Obesity TaskForce in 1996, how has the TaskForce evolved over the past 15 years? Probably when I was phoned by the Shadow Minister for Agriculture, when Tony Blair was leader of the opposition. At that time there was a major news story about the e-coli epidemic and all these horrid implications such as food poisoning and toxicology. This was also at the time when Bovine spongiform encephalopathy (BSE, mad-cow disease) was still very much in the headlines. The Shadow Minister for Agriculture said he had several questions to ask: Firstly, could I advise the Labour Party on what to do about these big clinical problems and how to prevent them? I said yes, of course. Secondly, could I make it (advising the Labour Party) public? I said yes, if any political party contacts me, I will do all I can do to help. Thirdly, can you meet Tony Blair tomorrow? I was supposed to be moving house that day from Cambridge to Aberdeen, as I was We started the TaskForce as we were continually being asked to appear on the television and the radio to tell all doctors that they had to take obesity seriously. I said that making endless appeals to doctors was completely the wrong way to go about it and that the World Health Organisation (WHO) should become involved. Having worked with the WHO as an academic-medic for a few years, I knew how to go about it. The International Obesity TaskForce essentially put global obesity ‘on the world map’ for the first time. Then, one of the first tasks was to identify the criteria for defining childhood obesity, as no proper definition existed. However, what really changed the medical and governmental approach was when the TaskForce published a report following three years of calculating how much of a health problem in terms of diabetes, cancer, heart disease etc obesity really was. Suddenly, obesity became the sixth highest risk factor in the world, it was truly ground-breaking. Subsequently, the TaskForce has developed strategies for governments around the world to help them combat obesity and helped the UK Chief Scientist to develop ‘The ForeSight Report’ (2007) that looked at the underlying social and economic causes, and the costs of obesity in the UK. The TaskForce has also helped to develop a European platform to work with the European Union and push the food industry to help combat the obesity epidemic. The TaskForce's original report to the WHO included waist measurements for clinical practice and the criteria for bariatric surgery. The data were subsequently used by the National Institutes of Health in the United States. Indeed, Dr Pi-Sunyer (Chair of the First Federal Obesity Clinical Guidelines), insisted that I attend the report’s launch as many people in the US were angry because the TaskForce was defining body mass index >25 as overweight, when the Americans wanted the BMI at >28. So, over the past 16 years we have been on a rollercoaster ride. But, the TaskForce has had some excellent people on-board. In particular, Neville Rigby, a former journalist who worked with us for ten years and who’s insights into public relations and lobbying proved invaluable. national rate of obesity and diabetes by identifying people with glucose intolerance, this work is very significant and establishes the case for a national (UK) programme against obesity. I personally believe that the UK’s National Health Service is ill prepared for the obesity epidemic and that bariatric provisions are insufficient given the huge demands for those resources. However, the government today is not willing to face up to the magnitude of the problem. You are currently President of the International Association for the Study of Obesity, what are the aims of the organisation? The IASO was originally established as an academic grouping assigned with the task of improving research into and educating professionals about obesity. We are now an English charity, so must operate within a certain remit. Our aims are now to change the medical and governmental approaches to the treatment and management of obesity. What are you current areas of research? I have been heavily involved with salt and, along with Claudio SanchezCastillo, developed the ‘lithium technique’ tracker method that showed 85% of salt in the UK diet comes from processed food. As a result, we have developed strategies to reduce salt intake and therefore How should we tackle the the rates of hypertension, which is obesity pandemic? now considered the top risk factor Some colleagues of mine from the across the world. I am also working Organisation for Economic and with the World Action on Salt and Cooperation and Development in Paris, Health (WASH) and Consensus. have looked at this very issue and have Action on Salt and Health (CASH) on calculated health economic costs. how to reduce the salt intake in poor They report that we need to completely countries, where they do not have a change our approach to both the lot of processed food but still have prevention and management of high levels of salt intake. obesity. As a result, we have assisted Away from surgery, how do the French and Nordic governments you relax? in restricting how the food industry By reading the newspapers, I am an markets their products to children. obsessive newspaper reader. I have On a clinical basis, we still have to been fortunate enough to travel to convince people that if you reduce most parts of the world, but for a your weight just a bit you can prevent holiday we enjoy cycling in France and a whole host of obesity-related health problems. In Finland, they have cut the have been there for the last 13 years. BMI is a significant predictor of mortality following surgery A study examining the relationship between body mass index (BMI) and 30-day mortality risk has reported that BMI is a ‘significant predictor’ of mortality within 30 days of surgery, even after adjusting for the contribution to mortality risk made by type of surgery and for a specific patient's overall expected risk of death. The researchers from the University of Virginia, Charlottesville, also noted that patients with a BMI of less than 23.1 appear to be at highest risk of death with 40% higher odds compared with patients in the middle range for BMI (26.3 to <29.7). To examine the relationship BMI and 30-day mortality risk among patients, the investigators utilised the database of the American College of Surgeons National Surgical Quality Improvement Program. A multi-variable logistic regression analysis was used to assess the statistical significance of the relationship between BMI and mortality, with adjustments for patient-level differences in overall mortality risk and principal operating procedures. Odds ratios per cent) among patients with with 95% CIs were cala BMI less than 23.1 was over culated to measure the twice that of the percentage of “These results relative difference in deaths (1 per cent) among paindicate that BMI is a tients with a BMI of 35.3 or mortality by BMI quintile, with reference to Additionally, patients significant predictor higher. the middle quintile of the with a BMI of less than 23.1 BMI. The overall signifhad statistically significant inof mortality within icance of the BMI and of creased risk of death, with 40 30 days of surgery” the other covariates was per cent higher odds of death measured using the Wald than patients with mid-range 2 test statistic. A separate BMI (between 26.3 and 29.6). multivariable logistic regression model was develWhen examining data by procedure category, oped to assess the significance of the interaction the authors also found that patients who underbetween BMI and primary procedure. went exploratory laparotomy had the highest perThe data included 189, 533 cases of general centage of death (13.9 per cent) compared with and vascular surgical procedures reported in 2005 patients in all other categories of principal surand 2006 for patients with known overall prob- gery, and patients who underwent breast lumpecabilities of death. Among these, 3,245 patients tomy had one of the lowest overall mortality perdied within 30 days of their surgery (1.7%). The centages (0.1 per cent). authors found that the percentage of deaths (2.8 The researchers also noted a statistically sig- nificant interaction between BMI and procedure category, indicating that the association between BMI and mortality was statistically different for patients who underwent these procedures (including colostomy, wound debridement, musculoskeletal system procedures, upper gastrointestinal procedures, colorectal resection, hernia repair, among others), compared with patients who underwent laparoscopy. “These results indicate that BMI is a significant predictor of mortality within 30 days of surgery, even after adjusting for the contribution to mortality risk made by type of surgery and for a specific patient's overall expected risk of death," the authors conclude. The study was published online by Archives of Surgery, one of the JAMA/Archives journals (The Relationship Between Body Mass Index and 30-Day Mortality Risk, by Principal Surgical Procedure. Turrentine et al. Arch Surg. November 2011). 8 BARIATRIC NEWS ISSUE 10 | January 2012 International Bariatric Club – a worldwide web network of bariatric surgeons Mr Haris Khwaja Laparoscopic Oesophagogastric/Bariatric Surgeon, United Kingdom Director: International Bariatric Club The International Bariatric Club (IBC) is currently the third largest bariatric organisation after the American Society of Metabolic and Bariatric Surgery (ASMBS) and the Brazilian Society for Bariatric Surgery. In 2008, the concept of the IBC was born through the visions of Dr Tomasz Rogula, Assistant Professor of Surgery (Cleveland Clinic, Ohio, USA), Dr. Raul Rosenthal, Professor of Surgery (Cleveland Clinic, Florida, USA) and Dr. Philip Schauer, Professor of Surgery at the Cleveland Clinic, Ohio. Initially the IBC consisted of onehour talks given by the Cleveland Clinic Bariatric Fellows, broadcast over the internet to an on-line audience. The talks were based on 1–2 recently published, high quality bariatric papers and were built within the educational curriculums of the Fellowship in Advanced Laparoscopy/Bariatric Surgery of both Cleveland Clinic campuses. These webinars initially attracted a small on-line audience but allowed for questions to be put to the speaker. I presented a webinar in 2009 during my Fellowship at the Cleveland Clinic – a review of the paper ‘Prevalence of Thrombophilias in Patients Presenting for Bariatric Surgery’ [Overby et al. Obes Surg. 2009 Sep;19(9):1278-85]. The paper had just been published and clearly was of great educational value to all attendees including on-line audience which on that occasion included surgeons from throughout the United Table I: Activities of the International Bariatric Club in 2011 Date Presenter Title of Talk May 13th, 2011 Dr. Mohammad Talebpour (Iran) 11 years Experience of Laparoscopic Greater Curvature Plication and its Modifications May 25th, 2011 Prof. Harvey Sugarman (USA) What Procedure is Best for T2DM in High and Low BMI Patients? June 29th, 2011 Dr. Manoel Galvao Neto (Brazil) Endoluminal therapy for obesity and T2DM is acceptable July 27th, 2011 Dr. Chih-kun Huang (Taiwan) Laparoscopic adjustable gastric banded plication: technique and preliminary results Sept. 1st, 2011 IBC at IFSO (Hamburg, Germany) Dr. Jaime Ponce (USA) Prof. Phil Schauer (USA) Prof. Mohammad Talebpour (Iran) Prof. Michel Gagner (USA) Prof. Chih-Kun Huang (Taiwan) Dr. Manoel Galvao Neto (Brazil) Prof. Mervyn Deitel (Canada) Bands no more? Bypass kills diabetes Plication kills sleeve Sleeve kills bands Bands on bypass and plication I can do it from inside What’s new in metabolic surgery? Sept. 28th, 2011 Dr. Shashank Shah (India) T2DM in the Indian Population Oct. 26th, 2011 Dr. Ariel Ortiz (Mexico) Live Demonstration: Laparoscopic Greater Curvature Plication Nov. 26th, 2011 IBC at IIIrd Romanian Bariatric Symposium (Bucharest) Prof. Mervyn. Deitel (Canada) Dr. Marius Nedelcu ( France) Dr. Tomasz Rogula (USA) Dr. Gianfranco Sillechia (Italy) Prof. Catalin Copăescu (Romania) Dr. Manoel Galvao Neto (Brazil) States, Brazil and China. It was clear to me that at this embryonic stage of the IBC that it had the potential to expand into a powerful educational medium for the exchange of bariatric knowledge globally. Indeed from these early days, IBC has grown significantly in terms of membership and its’ range of activities. The club still remains a free, non-profit making organisation open to all bariatric surgery/medicine professionals and easily accessible on-line to registered participants. In November 2010, the IBC Facebook Page was set up with the aim of promoting free discussion with bariatric professionals throughout the world Why Diabetes Does Not Resolve in Some Patients after Bariatric Surgery? Short Review of the Literature for Metabolic Surgery for Patients with BMI under 35 New Data about Cardiac Risk Factor after Bariatric Surgery Gastro-Esophageal Reflux after Bariatric Surgery Gastric Imbrications – Complication Rates, Leaks, Increased Salivation, Weight Regain. Is It Worth It? His Angle Fistula on Sleeve Gastrectomy Endoscopic Treatment, Dealing with a Nightmare on a daily basis. Following this the membership of the IBC expanded exponentially such that as of December 20th, 2011 there are 399 members from Europe, Asia, Africa Australia, North and South America. The aims of the IBC are outlined in the sidebar at the end of this article. Webinar Activities The monthly webinar in conjunction with WebEx web conferencing based at the Cleveland Clinic, Ohio, USA usually takes place the last Wednesday of the month at 17.00 (GMT) subject to occasional variation. It provides an opportunity for all members of the IBC to listen and/or see a high quality presentation by a national/international expert in bariatric surgery with the chance to ask questions to the speaker. These lectures are also recorded and so can be watched anytime. The club has also attracted global bariatric surgery leaders such as Professors Ariel Ortiz (Mexico), Manoel Galvao Neto (Brazil), Harvey Sugerman (USA), Michel Gagner (Canada), Philip Schauer (USA), Chih-Kun Huang (Taiwan) and Mohammad Talepbour (Iran). Table 1 (above) lists the presentations from 2011 which were not only informative but provided a great opportunity for an interactive on-line verbal discussion. In addition, the inaugural non-virtual IBC Symposium took place at the XVI World Congress of the International Federation for the Society of Obesity & Metabolic Surgery (IFSO) in Hamburg Germany in September 2011. The event was supported by former IFSO President, Professor Rudolph Weiner. A similar event is being organised for the IFSO-European Chapter (IFSO-EC) Meeting in Barcelona, Spain in April 2012 and at the next IFSO-World Congress in New Delhi, India, in September 2012 by the IBC organising committee. Future Aims The expansion of the IBC has been clearly enhanced by the internet. We are currently concentrating our efforts on maintaining the high standard of monthly Webinars with an increasing number of live webinars from the operating theatre. The IBC website will be ready by February 2012 and will allow any bariatric professional easy access to the latest IBC activities, video library and newsletter. We have already organised the next IBC non-virtual meeting in April 2012 at IFSO-EC in Barcelona, Spain with Professors Jacques Himpens (Belgium), Michel Gagner (Canada) and Rudolph Weiner (Germany) already confirmed speakers. These presentations will of course be broadcast live over the internet for any registered member to access. Long-term the IBC will, through multi-centre cooperation, be organising randomised controlled clinical trials in relation to bariatric surgery. This has only been possible through the recruitment of large number of enthusiastic, dedicated bariatric professionals as well as the involvement of world experts within the IBC. Membership Membership to the International Bariatric Club can be made by sending an email to Dr Tomasz Rogula, President of the IBC based at the Cleveland Clinic, Ohio, USA. ([email protected]). A link inviting you to attend the monthly Webinar via WebEx video conferencing provided by the Cleveland Clinic will be sent to you prior to the presentation. After registering you will receive a confirmation with the details of the upcoming International Bariatric Club Videoconference. Access to the live Webinar can be made via computer (PC or Mac) with a webcam or with a smart phone (iPhone, iPad, Android, Blackberry). Membership to the IBC from February 2012 will be possible through the IBC website. Aims of the International Bariatric Club Rudolph Weiner (IFSO Congress President 2011) and Michel Gagner at the IBC Symposium, XVI World Congress of IFSO, Hamburg, Germany (September 2011) Philip Schauer (left) (Past President ASMBS) and Tomasz Rogula (IBC President) at the IBC Symposium, IFSO (September 2011) 1 Promotion and exchange of knowledge, ideas and experiences related to the pre-operative, intraoperative and postoperative care of the bariatric patient with bariatric professionals throughout the world 2 Sharing of bariatric surgery videos relevant to management of intraoperative and postoperative complications 3 Promotion of the monthly Webinar coordinated by the Cleveland Clinic in association with WebEx 4 Mohammad Talebpour (Iran) – ‘Father’ of the Laparoscopic Greater Curvature Plication at the IBC Symposium, IFSO (September 2011) Chih-Kun Huang (Taiwan) – Presentation on ‘Bands on Bypass & Plication’ attracted great interest at the IBC Symposium at IFSO (September 2011) Promotion and Involvement in National and International Meetings relevant to Bariatric & Metabolic Surgery 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) • Details 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 10 BARIATRIC NEWS ISSUE 10 | January 2012 Travelling scholarship 2009 presentation Advanced Laparoscopic Fellowship at the Cleveland Clinic, Ohio, USA Haris Khwaja Post-CCT Gravitas Bariatric Surgery Fellow, Liverpool, United Kingdom The Bariatric and Metabolic Institute at the Cleveland Clinic, Ohio, USA is considered one of the leading bariatric surgery units in the world. I was fortunate to be selected after competitive interview whilst a Fourth Year SpR for the one year Advanced Laparoscopy/Bariatric Fellowship commencing from July 1, 2009 to June 30, 2010. The unit is headed by Professor Philip R Schauer, a global leader in bariatric surgery and four Attending Surgeons: Drs Tomasz Rogula, Stacy Brethauer, Bipan Chand and Matthew Kroh. The unit performs between 600–700 laparoscopic bariatric surgery cases per year and integral to its success is a dedicated multidisciplinary team consisting of bariatric physicians, anaesthesists, dieticians, psychologists, endocrinologists and bariatric nursing staff. The majority of the surgical workload is focused on the laparoscopic Roux-en-Y gastric bypass (LRYGB), sleeve gastrectomy (LSG) and revisional bariatric surgery including the banded bypass. The uniqueness of the Fellowship was the high frequency of super-super morbidly obese patients (BMI >60kg/ m2) who underwent surgery (the highest being a BMI=108kg/m2), as well as the acuity of the patients in terms of significant cardiovascular, respiratory and liver problems. These patients had often been turned down for bariatric surgery by other units in the United States and throughout the world. The unit is also at the forefront of clinical bariatric surgery research conducting the Laparoscopic Greater Curvature Plication (LGCP) trial and the Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) randomized study. The latter is comparing the effectiveness of advanced medical therapy alone for Type 2 diabetes mellitus versus surgery (sleeve gastrectomy or gastric bypass) and medical therapy combined. There are four Fellows selected per year with two on the one year Clinical Fellowship track and two on the two year Research/Clinical track. The Fellowship is divided into four three-month periods with each Fellow starting on a different part of the track. My Fellowship timetable is outlined in Table 1. The Fellowship is demanding compared to most Advanced Laparosco- Haris Khwaja (left) with Dr Tomasz Rogula (Attending Surgeon) at the Fellows Graduation Dinner, June 19 2010 py/Bariatric Fellowships in that there are no junior staff on the service so all ward rounds, electronic medical record documentation, admission/discharge paperwork and post-operative issues are undertaken by the Fellow. The advantage however is that all the surgeries are done by the Fellow. Average work days were 16 hours/day with a 1:5 on-call for Bariatric Surgery from home. There are on average twice weekly surgery days with theatre from 07:15–18:00 and twice weekly bariatric clinics from 08:30–17:00. In the one year Fellowship, I performed 349 cases consisting of 602 surgical procedures with the main cases outlined in Table 2. Postgraduate teaching is facilitated by a weekly Fellow’s Presentation on a topic based on the American Society of Metabolic and Bariatric Surgery (ASMBS) Curriculum, monthly Advanced Laparoscopy National/International Teleconferences, a monthly Bariatric Webinar (thorough the International Bariatric Club) and weekly Hepatobiliary Surgery meetings. The Fellowship allowed me to gain Haris Khwaja (right) in theatre with Dr Philip Schauer the Director of the Bariatric and Metabolic Institute, Cleveland Clinic Table 1 – Timetable of Clinical Fellowship Track Time Period Workload Attending (Consultant) Experience July 1 – Sept. 30, 2009 Minimally Invasive Surgery (2 full days/wk) Bariatric Surgery (2 full days/wk) Clinical Research (1 full day/wk) Dr. Philip Schauer Dr. Tomasz Rogula Dr. Steven Rosenblatt • Lap Roux-en-Y Gastric Bypass • Lap Sleeve Gastrectomy • Lap Splenectomy • Single Incision Lap Cholecystectomy • Lap Incisional/ Inguinal Hernia • Abstracts prepared & submitted to SAGES & ASMBS Oct. 1 – Dec. 31, 2009 Bariatric Surgery (2 full days/wk) Bariatric Clinics (2 full days/wk) Dr. Philip Schauer Dr. Tomasz Rogula • Lap Roux-en-Y Gastric Bypass • Lap Sleeve Gastrectomy • Lap/Open Revisional Bariatric Surgery Jan. 4 – March 31, 2010 Bariatric Surgery (1 full day/wk) Minimally Invasive Surgery (1 full day/wk) Diagnostic/Therapeutic OGD (0.5 day/wk) Bariatric Clinic (0.5 day/wk) Dr. Stacy Brethauer Dr. Matthew Kroh • Lap Roux-en-Y Gastric Bypass • Lap Sleeve Gastrectomy • Lap Gastric Band • Revisional Bariatric Surgery • Single Incision Lap Gastric Band • Lap Gastric Pacemaker • OGD/PEG Insertion • Book Chapter written April 1– June 30, 2010 Bariatric Surgery (2 full days/wk) Bariatric Clinics (2 full days/wk) Dr. Philip Schauer Dr. Tomasz Rogula •Lap Roux-en-Y Gastric Bypass •Lap Sleeve Gastrectomy •Lap/Open Revisional Bariatric Surgery •Lap Greater Curvature Plication • Presentations at SAGES & ASMBS The Cleveland Clinic, Ohio Table 2: Summary of the Main Advanced Laparoscopic/Bariatric Surgeries & Endoscopy Experience Operation Supervisor Trainer Supervisor Trainer Unscrubbed Scrubbed Lap Roux en Y Gastric Bypass 5 48 35 Lap Sleeve Gastrectomy 1 19 5 Lap Greater Curvature Plication - 2 4 Lap Revisional Bariatric Surgery - 2 15 Lap Total Gastrectomy - 2 3 Lap Splenectomy 4 4 1 Lap Nissen Fundoplication - 15 4 SILS/Lap Cholecystectomy - 9/37 3/2 OGD/PEG Insertion 123/12 - 1 the necessary technical skills and case volume to overcome the learning curve of the various bariatric surgeries and be able to undertake these surgeries independently. It also set me up for my Final Year as a SpR at Chelsea & Westminster Hospital, London (a premier UK bariatric surgery centre), where I performed an additional 69 laparoscopic gastric bypasses, 23 sleeve gastrectomies and 45 adjustable gastric bands. I would encourage any trainee with an interest in Advanced Laparoscopy/Bariat- Assisting ric Surgery to undertake a Fellowship. The American Fellowships do require planning ahead in terms of doing the necessary American USMLE exams in good time, attending interviews in America (I had 12 interviews but decided to attend two) and sorting out the visa requirements once a Fellowship has been granted. However the experience gained in working in a high-volume bariatric unit in terms of surgical training and pre/post-operative management of the morbid obese patient made it an extremely valuable year. ISSUE 10 | January 2012 Does bariatric surgery have a Halo effect? According to a study by researchers at Stanford University School of Medicine, family members of patients who have undergone bariatric surgery have reported weight loss and improvements in their lifestyles. This so-called ‘Halo effect’ is believed to be a result of the family’s close association with the patient. The findings were published in the October 2011 issue of the Archives of Surgery (Collateral Weight Loss in Patients' Family Members, Woodard et al. Arch Surg. 2011;146(10):1185-1190). “Family members were able to lose weight comparable to being part of a medically controlled diet simply by accompanying the bariatric surgery patient to their pre- and post-operative visits," said senior author Dr John Morton, Associate Professor of Surgery at Stanford and Director of Bariatric Surgery at Stanford Hospital & Clinics. “Bariatric surgery programs should encourage family involvement in support groups and education sessions to capitalise on these Halo effects.” Although it has been established that bariatric surgery is an effective treatment for morbid obesity, it is increasingly recognised as a familial disease and healthy behaviour transmission could be John Morton enhanced by family relationships. Therefore, the researchabolic equivalent task–hours drinks per month to one drink ers decided to investigate (equivalent to consuming per month; p=0.009). whether changes in weight 1kcal/kg body weight/hour; It is important to note that and healthy behaviour in pap=0.005), and from 13 to 22 all the study participants actients who underwent Rouxmetabolic equivalent task– companied the patients to all en-Y gastric bypass surgery of their pre- and post-operahad any subsequent impact on hours (p=0.04), respectively. Eating habits, which were tive clinical visits, where they their family members. received dietary and lifestyle The study ran from January measured by the Three-Factor Eating Questionnaire, also counselling. These sessions 2007 to December 2009 and improved among adult famwould emphasise a high-proincluded 85 participants (35 tein, high-fibre, lowpatients, 35 adult famfat and low-sugar diet ily members, and 15 and small, frequent children younger than “Family members were meals. The sessions 18 years). Of the adult also set daily goals for family members of able to lose weight exercise and stressed a the surgery recipients, comparable to being good night's sleep, al60% were obese pricohol moderation and or to the procedure, as part of a medically less time in front of the were 73% of the chilcontrolled diet simply television. dren of the patients. Surgery was combined by accompanying the Conclusion with dietary and lifebariatric surgery “In the US, we do style counselling. roughly 200,000 barpatient to their pre- and Results iatric surgery cases a post-operative visits… After 12 months, the year, and we struggle researchers observed with how to deal with Bariatric surgery a weight loss in adult the obesity epidemic in programs should family members, from society. Can you imaga mean of 234lbs to ine if every one of these encourage family a mean of 226lbs bariatric patients were (p=0.01). Children of an ambassador for good involvement in support patients trended tohealth?” added Morgroups and education ward lower body mass ton. “You would have a indices, from 31.2 kg/ huge, grassroots movesessions to capitalise on m2 (expected, based ment with bariatric surthese halo effects.” on growth projections) gery providing a vehicle to 29.6 kg/m2 obfor healthy change for served (p=0.07). The patient and family alike. researchers also noted an inObesity is a family disease and ily members, including a recrease in daily activity levels bariatric surgery sets the taduction in uncontrollable eatamong adult and child family ble for future, healthy family ing (from a score of 35 to 28; members, as measured by the meals.” p=0.01), a reduction in emoSeven-Day Physical ActiviThe study was funded by tional eating (from 36 to 28; ty Recall questionnaire, with 0=0.04), and a reduction in al- the school’s Medical Scholars changes from eight to 17 met- cohol consumption (from 11 Program. BARIATRIC NEWS 11 12 BARIATRIC NEWS ISSUE 10 | January 2012 A snapshot of In this issue, our ‘Snapshot’ features Canada and a joint report released by the Canadian Institute for Health Information (CIHI) and the Public Health Agency of Canada (PHAC), entitled ‘Obesity in Canada 2011’. The comprehensive new report examines how obesity rates vary across Canada, who is most at risk and possible actions to address it. Based on body mass index (BMI) calculations, the study reports that more than one in four adults (estimates range from 24.3%-25.4%) in Canada and just less than one in 11 children are considered obese. Between 1981 and 2009, obesity based on BMI data roughly doubled across all adult age groups and tripled for children (age 12 to 17). Alarmingly, the report states that ‘not only has the prevalence of obesity increased over time, but obesity is becoming more severe and fitness levels are decreasing as well’. N “ ot surprisingly, this report shows that improving lifestyle behaviours, such as healthy eating and physical activity, can have a significant impact on reducing the waistlines and improving the health of Canadians. However, obesity is complex, and there are many other factors that contribute beyond lifestyle habits,” says Jeremy Veillard, Vice President of Research and Analysis at CIHI. “By shedding light on the factors most closely associated with obesity and how they play out across Canada, policy-makers and health providers can better target prevention and treatment options to meet the needs of the population.” ty across health regions within Canada is large, ranging from a low of 5.3% in urban/suburban Richmond, British Columbia, to a high of 35.9% in the northern Mamawetan/Keewatin/Athabasca region of Saskatchewan (see Figure 1). Among both adults and youth, the proportion of overweight tends to be higher in rural areas than in metropolitan areas. In particular, in all the Canadian regions considered, obesity has been found to be most prevalent among boys in small town regions of 2,500 to 19,999. Furthermore, the investigation also demonstrates that self-reported obesity remains more prevalent among Aboriginal peoples than in the Canadian non-Aboriginal adult population. For example, 25.7% among off-reserve Aboriginal adults compared with 17.4% among non-Aboriginal adults in Canada. On-reserve First Na- tions groups tend to have a higher prevalence still, with over one-third (36.0%) estimated as obese, based on 2002/03 data. Self-reported obesity among adults is similar for Inuit, off-reserve First Nations, and Métis populations (23.9%, 26.1% and 26.4%, respectively), whereas childhood obesity varies from 16.9% among Métis to 20.0% among off-reserve First Nations to 25.6% among Inuit. Sex and age For both men and women, the report shows that the prevalence of obesity generally increases with each successive age group up to age 65. After age 65, the prevalence of obesity declines. In the 2007/08, obesity was more prevalent among men than women, with the exception of the oldest age group (Figure 2). Based on direct measures, findings from the 2007-2009 CHMS show that, while obesity increased with age, it was not always higher among men than women. For example, in the population aged 20 to 39, 19% of males and 21% of females were obese, and among those aged 40 to 59, 27% of males and 24% of females were obese. Distribution of BMI There has been a marked shift in the distribution of BMI over time, the greatest increases occurring in the heaviest weight classes (Figure 3: Distribution of BMI Categories by Sex, Ages 18 to 79, 2007-2009). For example, the proportion of adults falling into obese class I (BMI 30.0-34.9 kg/m2) increased from 10.5% in 1978/79 to 15.2% in 2004. The pro- portion in obese class II (BMI 35.0-39.0 kg/m2) doubled between 1978/79 and 2004, increasing from 2.3% to 5.1%. The proportion falling into obese class III (BMI≥40kg/m2) , while small, also appears to have increased over time. In 1978/79 obese class III made up 0.9% of the population and increased three-fold, to 2.7%, by 2004. Although females appear more likely than males to be within the normal weight group and less likely to be in the overweight group, they are more likely to fall into obese classes II and III. Socio-economic status or Created by: Matt Ward/Echo Enduring Media - www.echoendur 09; Distributed under the Creative Commons lisence. Regional and ethnic variation New analyses from the research shows a variation in self-reported obesi- Variations in obesity by socioeconomic status were much more pronounced in some regions than in others. In Halifax, Nova Scotia, for ex- BARIATRIC NEWS 13 Vector map created by: Matt Ward/Echo Enduring Media – www.echoenduring.com © 2009; Distributed under the Creative Commons lisence. ISSUE 10 | January 2012 ample, 11% of the population in the highest socio-economic range was obese, compared with close to 26% in the lowest socio-economic areas. Similarly, in Thunder Bay, Ontario, 10% of the population in the highest socio-economic areas was obese, compared with 20% in the lowest socio-economic areas. While most cities had a gap, it was not always significant. Some cities, like Vancouver, BC, and Oshawa, Ontario, showed almost no difference in obesity between the highest and lowest socio-economic areas. In addition, research summarized in the report has shown that access to recreational facilities and food retail outlets and the price of nutritious foods can all have an association with obesity. ring.com Gender and income The report also notes that women in higher income brackets were significantly less likely to be obese than their lower-income counterparts, a difference not found for men. This trend was seen for all Canadian women, although it was most pronounced among Aboriginal females, where 16.3% of Aboriginal women in households making C$100,000 or more were considered obese, compared with 26.8% of Aboriginal women in households with incomes of less than C$20,000 a year. Costs It has been estimated that obesity costs the Canadian economy approximately C$4.6 billion in 2008, up C$735 million (19%) from C$3.9 billion in 2000 (this estimate is limited to those costs associated with the eight chronic diseases most consistently linked to obesity, an additional study using comparable methodology and looking at 18 chronic diseases estimated the cost to be even higher, at close to C$7.1 billion). “Reducing obesity levels and promoting healthy weights is critical to the prevention of ill health,” says Dr Judith Bossé, Assistant Deputy Minister, Public Health Agency of Canada. “Obesity increases the risk of a number of chronic conditions, including type 2 diabetes, hypertension and some forms of cancers. That’s why we’re examining options to address the factors that lead to obesity, and we are working with various levels of government, non-governmental organisations and other stakeholders on this issue.” Source: The report ‘Obesity in Canada’ is available to download from the Public Health Agency of Canada: www.phac-aspc.gc.ca 14 BARIATRIC NEWS ISSUE 10 | January 2012 XVI World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders Highlights from IFSO 2011 The XVI World Congress of the International Federation for the Surgery of Obesity and metabolic disorders (IFSO) was held in Hamburg (August 30–September 3), under the auspices of the German Society for the Surgery of Obesity of the German Society for Visceral and General Surgery. The Congress was official- ly opened in an ceremony hosted by the Congress President, Professor Rudolf A Weiner and IFSO President, Professor Karl Miller. Overall, there were ten plenary sessions, ten symposia, one keynote lecture, six integrated health sessions and consensus conferences and 23 scientific sessions including video sessions allowing participants to focus on key topics including: implications of severe obesity; new technologies; metabolic surgery; controversies with interactive debate; lap revisional surgery; bariatric surgery and the law; and several multidisciplinary symposia. From 922 submitted abstracts a total of 589 abstracts were presented, this included 85 videos and 323 posters. The total number of oral presentations, videos and posters) was a record 784. The IFSO 2011 World Congress reflected the importance of metabolic surgery and began with the postgraduate course. As well as behavioural and medical approaches, various types of surgery on the gastrointestinal tract and new endoscopic techniques were highlighted. Many of the discussions concerned the ability of these new techniques to resolve diabetes not only in patients with severe obesity, but in patients considered of normal weight. In addition, there were several presentations focusing on the surgical approaches to type 2 diabetes mellitus (T2DM) that reported how surgery can help normalise blood glucose levels, thereby reducing or avoiding the need for medications, and providing a potentially cost-effective approach to treating the disease. An interdisciplinary plenary session with endocrinologists focused on research into surgery for the resolution of diabetes as well as looking at the non-weight-loss effects on glucose tolerance. Awards Several awards and scholarships were also presented, including: The best posters awards: 1st Poster prize: Kirstin Carswell (UK), 2nd Poster prize: James Rink (UK) and 3rd Poster prize (shared by two surgeons with the same ranking in the blind peer review): Conor Magee (UK), Susanne Richter (Germany). Three scholarships were also awarded to the following young surgeons: Maria Dolores Frutos (Spain), Jayashree Todkar (India) and Marco Bueter (Switzerland). A new concept for the Hamburg meeting was the electronic voting system in all Plenary sessions. The questions were established by the Scientific Committee together with the Chairman and voted on by the audience. Gastric Plication A special session focused on Gastric Plication Session and included experts from around the world, Chaired by Dr Phil Schauer. The session began with Dr Talebpour (Iran) presenting a multi-centre experience of over 800 procedures. Additional presentations included Dr Ramos (Brasil) who de- scribed plication as a ‘rescue technique’ following the failure of a previous procedure. There was relative agreement in the session that plication does have its merits, and has a place in the armamentarium of the surgeon, but surgeons performing the procedure should have formal training before attempting this technique. Dr Henry Buchwald gave several presentations that encompassed topical subjects including the ‘Guidelines for metabolic and bariatric surgery and the Center of Excellence concept – data on the efficacy of Center of Excellence in enhancing outcomes and decreasing complications. In addition, he looked into the future as he assessed 'Micro Orifice' surgery. Tantalus There were also several updates from device-related clinical studies. Professor Arthur Bohdjalian, Medical University of Vienna, presented favourable benefit-risk profile of the Diamond Henry Buchwald (Tantalus) System. This is a minimallyinvasive gastric stimulator for treatment of Type 2 Diabetes and its metabolic comorbidities. Bohdjalian stated that the system brings significant glycaemic and metabolic improvement with mostly mild to moderate adverse events. In the meta-analysis of 80 obese T2DM patients treated with the Diamond system for at least six months after failing on oral anti-diabetics, the results showed a mean reduction of 0.9% in HbA1c accompanied by significant weight loss, waist circumference reduction, lowering of blood pressure (systolic and diastolic) and an improvement in blood lipid profiles. In addition, the majority of adverse events reported were not related to the device and resolved within four weeks of implantation without sequelae. “Diamond’s safety and efficacy are due to the fact that it acts physiologically, enhancing the normal metabolic processes and not causing any metabolic dysfunction,” said Bohdjalian. “Therefore it is an attractive alternative treatment for managing Type 2 Diabetics who have exhausted oral medications.” Maestro EnteroMedics also presented data their VBLOC-DM2 ENABLE (DM2) tri- Congress President Professor Rudolf A Weiner and IFSO President Professor Karl Miller al evaluating the second generation Maestro RC System in the treatment of obesity, diabetes and hypertension. In an oral presentation entitled ‘Treatment of Obesity-Related Co-Morbidities with VBLOC Therapy,’ Dr Miguel Herrera Hernández, Instituto Nacional de la Nutrición, Mexico, said the results reflect a statistically significant and sustained improvement in glycaemic control and blood pressure, as well as clinically meaningful weight loss in obese, diabetic patients using the Maestro RC System. The 18-month data showed that excess weight loss (EWL) of approximately 24.6% (n=22), a mean reduction in HbA1c of 1.2 percentage points from a baseline of 8.1% (n=13), a change in fasting plasma glucose of -38.4 mg/dl from a baseline of 151.4mg/dl (n=12). In hypertensive patients (n=10), there was a reduction in mean arterial pressure of 13.0mmHg from a baseline Philip Shauer of 99.5mmHg and a reduction in diastolic blood pressure of 15.9mmHg from a baseline of 87.2mmHg (n=10). Through 18 months, no change in mean arterial pressure was observed in patients that did not present with hypertension (n=10). abilitI launch Also at IFSO, IntraPace, the developer of the innovative abiliti implantable obesity management system, launched its lifestyle management portal and support network. A unique online resource, my.abiliti allows its users to track personal eating and exercise performance, set and achieve goals, receive individual coaching, access educational resources and benefit from a valuable support network. They can also share personal experiences and achievements at their discretion with peers, friends and family, and experienced healthcare professionals. The abiliti system is an implantable device that uses proprietary eating event sensors to initiate gastric stimulation that helps patients feel full sooner than they otherwise would. Additionally, the device automatically records information on those eating and drinking events, as well as frequency and duration of exercise. IntraPace claims that the my.abiliti portal is the only online destination and community that can utilise objective behavioural data, collected and stored by the abiliti device and wirelessly retrieved with the connect.abiliti Wand. This accurate information enables intelligent weight loss management based on routine self monitoring. Record attendance IFSO 2011 was attended by 2,230 participants from 74 countries and as well as 425 exhibitors, the highest number in the history of the IFSO World Congress. BARIATRIC NEWS 15 ISSUE 10 | January 2012 Commercial vs. NHS-based weight loss programmes According to a study published in at bmj.com (BMJ, 2011; 343), commercial weight loss programmes are more effective and cheaper than National Health Service-based services led by specially trained staff. Researchers at the University of Birmingham compared the effectiveness of several commercial weight loss programmes of 12 weeks' duration with primary care-led programmes and a control group. A total of 740 obese and overweight men and women took part in the study. Follow-up data were available for 658 (89%) participants at the end of each 12-week programme and 522 (71%) at one year. The programmes included in the analyses were Weight Watchers; Slimming World; Rosemary Conley; a group-based dietetics programme; general practice one to one counselling, pharmacy one to one counselling; or a choice of any of the six programmes. A control group was provided with 12 vouchers enabling free entrance to a local leisure (fitness) centre. All programmes achieved significant weight loss after 12 weeks, with the average weight loss ranging from 4.4kg (Weight Watchers) to 1.4kg (general practice provision). The primary care programmes were no better than the control group at 12 weeks. At one year, statistically significant weight loss occurred in all groups apart from the one to one programmes in general practice and pharmacy settings. However, Weight Watchers was the only programme to achieve significantly greater weight loss than the control group. All groups showed some increase in physical activity, although the smallest increase was in those allocated to the general practice programme. Attendance seemed to be an important factor; the highest attendance rate was in Weight Watchers and the lowest for the primary care programmes. The primary care programmes were also the most costly to provide. “Our findings suggest that a 12-week group-based dedicated programme of weight management can result in clinically useful amounts of weight loss that are sustained at one year,” the authors note. “Commercially provided weight management services are more effective and cheaper than primary care-based services led by specially trained staff, which are ineffective.” Diet Express offers franchises in Dubai The British diet company, Diet Express, has begun trading in Dubai, offering dieting packages in health clubs throughout the United Arab Emirates (UAE). Diet Express have been working to secure contracts in the UAE since September 2011, and are currently offering their products through six health clubs in the city of Dubai. Chris Donaldson, Managing Director of Diet Express, said “after a slow start, coming up to Christmas things have really taken off.” The company offers packages and dietary supplements to franchise holders promoting a low-glycemic diet, including the “diet in a box”, which includes a body fat monitor, a journal, and a low-GI meal plan. They also provide materials to allow franchise operators to run more in-depth packages, including one-to-one consultations and weekly weigh-in groups. While Diet Express has in the past promoted their products based on their claims to help users lose weight, they have recently been advertising the role of a low-GI diet in preventing and controlling diabetes. The company is hoping to build on their recent expansion, and they are planning for new contracts that will see their products sold in health clubs in Egypt and Uganda in the new year. Until recently, they have only operated in the UK and Ireland. In 2010, the company worked with Belfast City Council to create a weight loss programme for families in the city. They have also partnered with Northern Ireland’s South Eastern Health and Social Care Trust to help offer dieting advice and support for the region’s diabetes patients. Obesity is a serious problem in the Emirates: while 75% of UAE residents surveyed in Philips’ recent Health and Wellbeing Index believed that they were not overweight, the Health Authority-Abu Dhabi’s Weqaya study found that 34% of Emirati adults are overweight and a further 36% are obese. Research has also shown that 25% of Emirati adults are at risk of developing diabetes. 16 BARIATRIC NEWS ISSUE 10 | January 2012 iBariatrics – patients go digital Simon Monkhouse Specialist Registrar, South West announces name change SOBA, formerly known as the Soci- ety Of Bariatric Anaesthetists, has announced that it has changed its name to the Society for Obesity and Bariatric Anaesthesia, effective December 2011. SOBA is the largest specialist society for anaesthesia for the morbidly obese in the world. One of its roles is to facilitate excellence in the management and safety of obese patients in a much wider field than just bariatric surgery. There is significant demand for teaching and training in the care of the obese patient non bariatric surgery (and critical care) as in bariatric surgery, and SOBA believes the Society for Obesity and Bariatric Anaesthesia much better reflects the wider aims of the Society. SOBA runs three scientific meetings per year. Spring and late Autumn meetings held in the north (York in 2012) and London respectively, are aimed at anaesthetists who are just starting a bariatric service, are planning to become involved in the field and also non-specialist bariatric anaesthetists with an interest in anaesthesia for the obese patient. The third meeting, held in late September is a specialist bariatric anaesthesia meeting, and has an international profile. In 2012 this meeting will be held in Taunton. For further details about SOBA please visit www.sobauk.com SOBAUK No longer do patients have to trawl through hundreds of websites on the internet or browse the health section of the local book store, all they need to do is download an app. Sally Norton (Consultant Bariatric Surgeon, Bristol), Sharon Bates (Obesity Nurse Specialist and counsellor, Bristol) and Simon Monkhouse (Specialist Registrar, South West) have combined forces to create a unique series of apps for weight loss surgery patients. There is an app for each operation – ideal for those who have just had surgery. For those who are thinking about surgery the series of apps will be a useful addition to their mobile phones. myGastricBand, myGastricBypass, myGastricSleeve and myGastricBalloon all have an eye catching, similar format which will guide the user through their post-surgery journey. Every app has five subsections resulting in a comprehensive post surgery information and reference resource. myProfile allows documentation of date of surgery, type of surgery or procedure and location, together with personal details such as age and BMI. There is a visual description of the operation they have just had and an opportunity to document their goals. Do they want to fit into a particular dress by Christmas? What is their target weight? It includes space for emer- Sally Norton and Simon Monkhouse gency contact numbers and appointment details. This is a useful source of reference for them to keep close at hand. A weight loss and clothes size tracker is included in myProgress to give them visual record of their progress. In myGastricBalloon a monthby-month programme also provides the opportunity to gain gold stars as goals are ticked off one by one – Pavlov and his dogs would be happy! myHealth section is the back bone of the app with tips and tricks on how to keep fit and well post surgery – in mind as well as body. Information on psychology and exercise are provided along with advice on vitamins and other supplements. Importantly, this section also warns patients of the potential (though thankfully rare) SOBAUK Society for Obesity and Bariatric Anaesthesia Safe anaesthesia for the morbidly obese patient The Hospitium, Museum St, York YO1 7FR Friday 20th April 2012 9:20 Registration & Coffee 9:50 Introduction and Welcome: Aims of the Day 10:00 Treating Obesity - Why and how? 10:30 Practicalities of managing the obese patient - Staff, Organisation, Equipment and positioning 11:00 Coffee 11:30 Pre-operative assessment 12:40 Lunch 13:30 The Airway & Ventilation 14:00 Pharmacokinetics of Obesity: Induction, Maintenance, Analgesia 14:30 Regional anaesthesia in the obese 15:00 Afternoon Tea 15:30 The obese parturient 16:00 Postoperative care and DVT prophylaxis 16:30 Meeting close 5 CPD Points applied for SOBA Members and trainees £125 Non-members £150 For registration and further information visit www.sobauk.com Joining SOBA is just £25 per annum and gives discounted entry to all our meetings and seminars as well as a host of other benefits. late complications of weight loss surgery, guides the user to recognise the early warning signs and advises on when to seek help. myQuestions is full of helpful hints on how to eat out, what to eat, how to recognise feeling full and is written from a very personal perspective. Evidence-based information combined with personal anecdote make this section friendly yet informative. The More section gives patients the opportunity to contact weight loss professionals together with the opportunity to enter forums and meet like-minded individuals. This is an exciting development in patient support. Look out for the apps in the iTunes App Store in the very near future. For more information visit www.weightlosssurgeryclinic.co.uk BAPRAS call for body contouring guidelines A British plastic surgery association is pushing for national guidelines for the commissioning of body contour surgery in the NHS. The British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) are currently inviting stakeholder organisations to an initial consultation. They hope to establish the key points to be considered for the development of guidelines for body contour surgery. NICE currently offer no such guidelines, and BAPRAS claim that this has created a postcode lottery in body contour commissioning. Simon Kay, Professor of Hand Surgery at the University of Leeds and BAPRAS’ communications chair, said “In some parts of the country you can have this operation done on the health service, in other parts you have to go before a panel, and in other parts there’s a complete ban on it.” While Kay described the evidence supporting the use of the surgery as “sporadic”, he said that he hoped the planned consultation would consolidate the existing evidence base. A pilot study presented at BAPRAS’ Winter Meeting by Mark Soldin, consultant plastic surgeon at Kingston and St Georges University Teaching Hospitals, indicated significant improvements in patients’ physical and emotional wellbeing following the surgery. However, he was keen to emphasise that BAPRAS was not lobbying for the supply of body contouring surgery on the NHS; rather, they were seeking greater nationwide consistency in its provision. “We want to act as an informed adviser, rather than a lobbyist,” said Kay. “We don’t act for one group or another but we’ve realised that when the commissioning groups are making decisions about commissioning they may need authoritative advice.” Excess skin following heavy weight loss can result in conditions including soreness, recurrent infections, functional problems, depression, difficulty with sexual function and poor body image. “Very often the weight loss will result in a patient whose diabetes is reversed, whose risk of arthritis is reduced, whose heart attack risk is reduced, but who won’t re-enter society, as it were, because of the stigmatising skin redundancy,” said Kay. BAPRAS are hoping to attract a number of stakeholder groups to take part in the consultation, representing medical providers, patients and the Department of Health. Kay said that while he expected the patient groups to be very supportive of the commissioning, the government organisations might not consider the benefits to be worth the price of the surgery. “The cost implications are quite considerable,” said Kay. “If you do fund the surgery, the plastic surgery after dramatic weight loss is substantially more expensive than the bariatric surgery, in terms of the length of stay, the complications, and the operating time.” A recent study carried out by BAPRAS showed that only 45% of British GPs support the NHS offering body contouring surgery following bariatric surgery. However, Kay said he hopes that this will rise with increased awareness of the implications of the surgery. “They may not understand what’s involved – what the implications are, what the costs are, what the stress for the patient is,” said Kay. “They may not understand the utility and the benefits.” BARIATRIC NEWS 17 ISSUE 10 | January 2012 Researchers from the Universi- ty of Alberta claim that their risk assessment scoring system, the Edmonton obesity staging system (EOSS), improves on current methods in helping to predict the risk of death in overweight and obese people. The study has been published in the Canadian Medical Association Journal (Padwal et al. CMAJ October 2011;183;14). According to the researchers, anthropometricbased classification schemes for excess adiposity (such as body mass index [BMI]) do not include direct assessment of obesity-related comorbidity (numerous conditions that may be associated with excess weight) and functional status, and cannot distinguish between lean and fat tissue. Therefore, BMI has limited clinical utility. The EOSS, originally proposed by Dr Arya Sharma from the University of Alberta, ranks overweight and obese people on a five-point scale according to their underlying health status and the presence or absence of underlying health conditions. It is a clinical staging system that ranks people with excess adiposity on a five-point ordinal scale, while incorporating obesity-related comorbidities and functional status into the assessment (Figure 1). 0 No apparent risk factors (e.g., blood pressure, serum lipid and fasting glucose levels within normal range), physical symptoms, psychopathology, functional limitations and/or impairment of well-being related to obesity. 1 Presence of obesity-related subclinical risk factors (e.g., borderline hypertension, impaired fasting glucose levels, elevated levels of liver enzymes), mild physical symptoms (e.g. dyspnea on moderate exertion, occasional aches and pains, fatigue), mild psychopathology, mild functional limitations and/or mild impairment of well-being. 2 Presence of established obesity-related chronic disease (e.g., hypertension, type 2 diabetes, sleep apnea, osteoarthritis), moderate limitations in activities of daily living and/or well-being. 3 Established end-organ damage such as myocardial infarction, heart failure, stroke, significant psychopathology, significant functional limitations and/or impairment of well-being. 4 Severe (potentially end-stage) disabilities from obesity-related chronic diseases, severe disabling psychopathology, severe functional limitations and/or severe impairment of well-being Figure 1: Arya Sharma's five-point scale ranking overweight and obese people according to their underlying health status. EOSS has previously been used to predict death using data from a population-representative survey of 8,143 people in the 1988-1994 and 1999-2004 US National Health and Human Nutrition Examination Surveys (NHANES). In this latest study, researchers undertook a rigorous examination of EOSS and assessed its ability in predicting mortality independent of anthropometric indices in a large, nationally representative US sample. The investigators analysed data from NHANES III (1988–1994) and the NHANES 1999–2004, with mortality follow-up through to the end of 2006. Adults (age ≥20 year) with overweight or obesity who had been randomised to the morning session at the mobile examination centre were scored according to the Edmonton obesity staging system. They examined the relationship between staging system scores and mortality, and Cox proportional hazards models were adjusted for the presence of the metabolic syndrome or hyper-triglyceridemic waist (waist circumference ≥90cm and a triglyceride level ≥ 2mmol/L for men; and ≥85cm and ≥1.5mmol/L for women). More than 75% of the cohort with overweight or obesity were given scores of 1 or 2. Scores of 4 could not be reliably assigned because specific data elements were lacking. The survival curves clearly diverged when stratified by scores of 0–3, but not when stratified by obesity class alone. Within the data from the NHANES 1988–1994, scores of 2 (hazard ratio [HR] 1.57; 95% confidence interval [CI] 1.16 to 2.13) and 3 (HR 2.69; 95% CI 1.98 to 3.67) were associated with increased mortality compared with scores of 0 or 1, even after adjustment for body mass index and the metabolic syndrome. The researchers found similar results after adjusting for hypertriglyceridemic waist, as well as in a cohort eligible for bariatric surgery. The study found that within a nationally representative cohort, higher EOSS scores were a strong predictor of increasing mortality in both the overall population and in a cohort of people eligible for bariatric surgery, independent of BMI and the presence of metabolic syndrome or hypertriglyceridemic waist. Moreover, even within strata of BMI categories, there was clear separation of survival curves (Figure 2), the authors noted. Padwal R S et al. CMAJ 2011;183:E1059-E1066. ©2011 by Canadian Medical Association EOSS predicts risk of death for bariatric patients Figure 2: Comparison of staging system and anthropometric classification scheme for predicting all-cause mortality among people with overweight and obesity. Limitations Despite the results from the study, the authors do acknowledge that the study does have some limitations. For example, comorbidities were arbitrarily assigned to be equivalent in terms of their burden of illness although it is not yet clear whether certain comorbidities should receive a higher weighting. Moreover, the researchers made no distinction between types of diabetes (of Americans with diabetes, 90%–95% have type 2 diabetes). However, both subtypes would require management in an overweight or obese cohort and were thus judged appropriate for inclusion. CMS Lap-Band change reduced costs and increased safety According to a study featured in the journal Annals of Surgery (December 2011;254;6;860–865), the February 2006 decision by the Centers for Medicare and Medicaid Services (CMS) to restrict reimbursement for bariatric surgery to accredited centres and include coverage for laparoscopic adjustable gastric band (LAGB), reduced the cost of procedures and increased safety measures. Prior to the 2006 changes, the CMS only reimbursed gastric bypass surgeries. As a result, Dr David Flum, the study's lead author and a Professor at the University of Washington, and colleagues decided to investigated the impact of the CMS’ bariatric surgery national coverage decision on the use, safety and cost of care for CMS beneficiaries. Study design The researchers established a cohort study using nationwide Medicare data (2004–2008) evaluating rates of bariatric procedures/100,000 enrolees, 90-day mortality, readmission rate and payments. Table 1: Procedure rates pre- and post-NCD ORYGB* LRYGB** Pre-NCD 56.0% 35.5% LAGB*** n/a Post-NCD 12.8% 48.7% 36.7% *Open roux-en-y gastric bypass (ORYGB) **Laparoscopic roux-en-y gastric bypass (LRYGB) Table 2: 90-day mortality rate pre- and post-NCD ORYGB LRYGB LAGB Total Pre-NCD 1.8% 1.1% n/a 1.5% Post-NCD 1.7% 0.8% 0.3% 0.7% p value <0.001 Table 3: 90-day re-admission, re-operation and payments pre- and post-NCD Re-admission Re-operation Payments p value Pre-NCD 19.9% 3.2% US$24,363 <0.001 Post-NCD 15.4% 2.1% US$19,746 <0.001 A total of 47,030 patients underwent procedures at 928 sites pre-NCD and 662 post NCD. The procedure rate/100,000 patients dropped after the NCD to 17.8 (from 21.9 in 2005) increasing to 23.8 and 29.1 in 2007 and 2008, respectively. Pre and post NCD data are seen in Tables 1, 2 and 3 Conclusions The NCD was associated with Adjustable gastric band a temporary reduction in procedure rate and a shift in types of procedures and patients undergoing bariatric surgery. It was associated with a significant decrease in the risk of death, complications, readmissions, and per patient payments. The research revealed that out of every 1,000 people who had weight loss surgery before the CMS decision died within 90 days of the procedure. After the rules change, seven out of every 1,000 people died after the surgery. Furthermore, re-admission and reoperations also dropped, as did the cost of the procedure. The NCD limited reimbursements to hospitals that receive a particular accreditation through the American College of Surgeons or the American Society for Bariatric Surgery by performing a certain number of procedures each year and by having staff and facilities that meet certain standards. Before Medicare's new requirement for accreditation in 2006, patients received surgery at 928 sites. Afterward, patients went to 662 facilities for surgery. This resulted in a decrease in access in places that were not accredited; however, the authors support the notion of accreditation standards around safety or volume, as this has been proven to improve outcomes. The CMS’ current coverage for weight loss surgery excludes sleeve gastrectomy (see page 6) and officials are seeking input on whether there are enough data on its effects and safety to include the procedure. Conclusion Nevertheless, the investigators concluded that the EOSS is a strong predictor of increasing mortality independent of BMI, metabolic syndrome and hypertriglyceridemic waist. It independently predicted increased mortality even after adjustment for contemporary methods of classifying adiposity. The authors proposed that this system should be considered adjunctive to current anthropometric classification systems in assessing obesity-related risk, determining prognosis and guiding potential bariatric surgery treatment options. FDA warning for misleading Lap-Band adverts The Food and Drug Administration (FDA) has sent a warning letter to several companies for using misleading advertising to promote Lap-Band weightloss surgery. The Agency said the companies have failed to sufficiently convey the serious risks carried by weight-loss surgery. The warnings are in response to complaints from a public health agency and Allergan, which manufactures the Lap-Band device. “FDA’s concern is that these ads glamorise the Lap-Band without communicating any of the risks,” said Steven Silverman, Director of the Office of Compliance in FDA’s Center for Devices and Radiological Health. “Consumers, who may be influenced by misleading advertising, need to be fully aware of the risks of any surgical procedure.” The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing and promoting drugs and medical devices. The letters are not legally binding, but the FDA can take companies to court if they are ignored. “The decision to undergo a gastric banding procedure should be done in close consultation between a patient and his or her health care provider,” said Dr Kimber Richter, Deputy Director for Medical Affairs in the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “It is important for the patient to fully understand both the risks and the benefits of the procedure and for the health care provider to be sure the procedure is appropriate for the patient.” 18 BARIATRIC NEWS ISSUE 10 | January 2012 ASGE/ASMBS TaskForce publishes EBT white paper A joint TaskForce from the American Society for Gastrointestinal Endoscopy (ASGE) and the American Society for Metabolic and Bariatric Surgery (ASMBS) has recently published a white paper concerning endoscopic bariatric therapies (EBTs). Specifically, the white paper is intended to provide a framework for, and a pathway towards, the development, investigation, and adoption of safe and effective EBTs. “The two societies formed a joint task force to identify opportunities where endoscopic treatments may play a role in improving patient outcomes and reducing costs,” said Dr GreGregory Ginsberg gory G Ginsberg, ASGE president and Chair of the ASGE/ASMBS Task Force on EBTs. “The white paper establishes the criteria for success as new technologies and procedures are developed.” The white paper entitled, ‘A Bipan Chand Pathway to Endoscopic Bariatric Therapies’, states that EBTs may have various roles in the treatment of the obesity epidemic, including primary therapy, early intervention, bridge therapy, and metabolic therapy. They will also have varying degrees of intensity, durability, and repeatability and therefore should be evaluated based on intent of therapy and their overall risk/benefit, stated the white paper. “Endoscopic therapy has the potential to be applied across the continuum of obesity and metabolic disease,” said Dr Bipan Chand, Chairman, ASMBS Emerging Technology and Procedure Committee, and Co-Chair of the ASGE/ASMBS Task Force. “However, it is generally expected that endoscopic modalities achieve weight loss superior to that produced by medical and intensive lifestyle interventions, have a favourable risk/benefit profile and have scientific evidence to support its use.” The white paper addresses a number of issues including endoscopic bariatric therapy treatment classification, potential indications, efficacy endpoints (threshold for weight loss and study design etc) and secondary efficacy endpoints (reduction in obesity-related co-morbidities, changes in quality of life, safety, durability and repeatability etc), the adoption of EBTs in the context of global patient care, training and credentialing, cost effectiveness and government and industry relations. The white paper emphasises that any new surgical, endoscopic or nonsurgical weight loss intervention should include a defined threshold of efficacy, balanced with risks of the intervention. EBT potentially offers an ambulatory weight loss procedures with a superior safety and cost profile compared to bariatric surgery, and if it is shown to be feasible, safe, and effective, EBT therapy could be appropriate for intervention to individuals with lower classes of obesity (ie, Class I). Treatment mechanism Several EBTs are currently in different stages of development, and include a variety of methods to induce weight loss and reduce obesity-related comorbidities. EBT technologies can be categorised broadly according to the intended mechanism of action: gastric restriction or manipulation, malabsorption, neuro-hormonal alterations, or some combination. Some EBTs attempt to decrease effective stomach capacity. These technologies include spaceoccupying devices and those that alter gastric anatomy. According to the white papers, these space-occupying devices most commonly take the form of temporarily placed prosthetic balloons, which effectively restrict intake, thereby enhancing satiety and instigating weight loss. Weight loss and improvements in metabolic comorbidities after malabsorptive surgical procedures are more profound than after purely stomach altering restrictive operations, and have prompted the development of endoscopic devices to induce malabsorption. These therapies are designed to create a physical barrier between food, the intestinal wall and biliopancreatic secretions. One such device is the duodenal-jejunal barrier sleeve, which may be placed temporarily or left in-situ indefinitely. These impermeable fluoropolymer sleeves open at both ends, are placed endoscopically, and anchor in the proximal duodenum or at the gastroesopha- geal junction. They prevent chyme from contacting the proximal intestine while bile and pancreatic secretions pass along the outer wall of the liner and mix with chyme in the distal jejunum. Other EBTs, still in early stage development, aim to modulate satiety and food intake through neuralhormonal mechanisms. Evidence suggests that gut hormones act in conjunction with the complex enteric nervous system to coordinate and regulate gastrointestinal satiety signals, motility, and digestive processes. Novel endoscopic devices seek to take advantage of this interaction by manipulating neural-hormonal signals to induce satiety. Their intended mechanism of action is to interfere with vagal signals between the brain and gastrointestinal tract, through a variety of techniques such as gastric stimulation or pacing, neuromodulation, and vagal resection. Intent of endoluminal therapies The primary goal of EBT is to induce enough weight loss to decrease obesity related metabolic co-morbidities and improve quality of life. Compared to current surgical interventions, EBTs are expected to yield substantial improvements and achieve a favourable risk/benefit profile. However, while a lower risk EBT must achieve this primary goal, its threshold for efficacy should be lower than a higher risk intervention. With this concept in mind, endoluminal therapies have many potential applications as primary, adjunctive or revisionary bariatric procedures. Intragastrinal balloon Specifically, the indications for EBT include primary therapy, early intervention/pre-emptive therapy, bridge therapy, and metabolic therapy. For each of these indications, the white paper considered the minimum threshold for efficacy, risk profile, durability and repeatability. Primary therapy An EBT with morbidity and mortality comparable to laparoscopic adjustable gastric banding should hold similar efficacy, with the potential to achieve approximately 40% excess weight loss. Alternatively, lower efficacy is acceptable for an EBT with a lower risk profile. Such treatments would be considered for patients with severe obesity Early intervention/preemptive obesity therapy patients with Class I and II obesity are at risk for disease progression, have a higher cardiovascular risk profile, and have a substantially increased relative risk of all-cause mortality. There is evidence that patients with Class I obesity respond well to surgical intervention. Prospective trials of both sleeve gastrectomy and adjustable gastric banding in patients with Class I obesity have demonstrated significant weight loss and resultant improvement in or resolution of many obesity related co-morbidities. Several other non-randomized studies have confirmed similar results. As a result, the FDA recently approved the use of gastric banding for patients with Class I obesity and at least one associated obesity related co-morbidity. The durability or repeatability of an EBT will be important. For a procedure to be repeatable, the patients’ anatomy must have minimal permanent alteration and be amenable to future intervention. Bridge therapy The intent of ‘Bridge Therapy’ is to promote weight loss specifically to reduce the risk from a subsequent intervention, including bariatric surgery. Patients with Class III obesity and those with metabolic co-morbidities present greater technical challenges and surgical risk than less obese, healthier patients. Furthermore, these effects are more pronounced in patients with BMI>60 where there is a greater risk of morbidity or mortality than patients with BMI 45-60. Metabolic therapy EBT may be justified in patients with less severe obesity (Class I), where improvement in metabolic illness is the primary concern. In particular, comorbidities such as type II diabetes, hyperlipidemia, and hypertension, may improve or resolve with even modest weight loss. Procedures which aim to effect metabolic dis- ease should have a lower risk profile and greater durability compared to therapies which specifically aim to induce massive weight loss. Substantial weight loss may not be necessary in order to achieve metabolic benefits in less severely obese individuals. Obese patients who lose 5% of their total body weight benefit from significant reductions in diabetes and cardiovascular risk factors including hypertension and dyslipidemia. Therefore, The TaskForce advocates using 5% of total body weight lost as the absolute minimum threshold for any non-primary EBT (eg, early intervention, bridging or metabolic therapy). Comparison of nonsurgical and operative interventions is limited by differences in the primary outcome measure: nonsurgical interventions typically use actual weight lost or % of total body weight, whereas operative therapies traditionally use %EWL. Threshold for weight loss for endoscopic therapies The weight loss threshold for the adoption of any new endoscopic procedures should be balanced against the risk of that procedure. Currently there are no established thresholds for endoscopic bariatric interventions. However, in general it is expected that endoscopic modalities should achieve weight loss superior to that anticipated with medical and intensive lifestyle interventions. Pharmacologic agents such as orlistat have been FDA approved despite their modest effects because 1) lifestyle interventions have even lower efficacy and poor durability/compliance and 2) small amount of lost weight (5% of total body weight or less) can lead to significant reductions in obesity-related co-morbidities. Therefore, based on available evidence and expert opinion, the TaskForce recommends that an EBT intended as a primary obesity intervention should achieve a mean minimum threshold of 25% EWL measured at 12 months. This goal will vary depending on the category or intent of endoscopic bariatric procedure. EBT should also be compared to a second treatment group, not necessarily a sham. Sham groups in comparative trials evaluating the efficacy of bariatric therapies have shown considerable variability in weight loss (3-13% EWL). In addition to the absolute threshold of weight loss, the mean %EWL difference between a primary EBT and control groups should be a minimum of 15% EWL, and be statistically significant. For other categories of EBT, the amount of EWL and durability of the effect may vary by type and intent of the EBT. As previously described, EBT may be performed for early intervention, bridge therapy, and as a metabolic therapy. In these instances, the primary endpoint may include, but not be limited to, an improvement or resolution in metabolic illness, decreasing the risks associated when performing another planned intervention, and preventing the progression to greater severity of obesity with its associated risks. The Tantalus System (above) and the VBLOC (left) BARIATRIC NEWS 19 ISSUE 10 | January 2012 Study design As a device is designed and modified to address a specific clinical need various types of studies are typically required as part of the regulatory process. Following rigorous preclinical evaluation, a feasibility study in humans is often the appropriate next step. The concept of such feasibility studies is well described in the FDA guidance documents. These are typically small studies performed in a limited number of subjects to confirm design and operating specifications. The emphasis is on technical feasibility and safety. Device modification is often necessary in this phase and flexibility is emphasized. There are typically no efficacy targets and the final results are generally used to calculate sample size and establish parameters for a larger pivotal trial. Clinical studies have shown that sustained moderate weight loss achieved through dietary and lifestyle intervention lowers blood pressure, improves glucose control, prevents diabetes, and improves dyslipidemia, haemostatic and fibrinolytic factors. Obese patients who lose 5% of their total body weight benefit from significant reductions in diabetes and cardiovascular risk factors including hypertension and dyslipidemia. Therefore, the TaskForce advocates using 5% of total body weight lost as the absolute minimum threshold for any EBT intended for anything but a primary bariatric intervention (eg, early intervention, bridging or metabolic therapy). Given that weight has significant metabolic effects, a 5% reduction could result in an improvement in or resolution of obesity-related co-morbidities such as diabetes mellitus, hypertension, obstructive sleep apnea and nonalcoholic fatty liver disease. If an endoscopic intervention proves to have a significant impact on one or more of these co-morbidities with a negligible risk profile, the threshold for intervention may extend to Class I obese individuals (BMI 30-35kg/m2). In addition to lowering the prevalence of co-existent obesity-related metabolic illnesses, there is potential for an EBT to primarily prevent these comor- Join bidities by promoting weight loss in mildly obese individuals. In this population, it is important that improvement/resolution of comorbidities be significantly better for endoscopic therapies compared to that of control groups, given the risks associated with any intervention despite how minimal they may be. Improvement and resolution of comorbidities should be defined using objective and standardised criteria. The safety of an EBT at a moderate intensity level implies a higher incidence of bleeding, perforation and other complications, similar to that observed with interventional endoscopic procedure such as therapeutic endoscopic ret- Endobarrier rograde cholangio-pancreatography with sphincterotomy. The safety of EBT at a high intensity level would be similar to that seen perioperatively with low risk operative procedures such as the adjustable gastric band. They would typically employ general anaesthesia (endotracheal intubation) as well as extended observation periods. Durability and repeatability The goal of primary bariatric surgical therapies is to induce substantial and sustainable weight loss with associated metabolic benefits. These same expectations apply to EBT, as a primary weight loss therapy. However, an EBT with reduced durability may be offset by repeatability of the intervention; EBT is particularly suited to this approach. Low risk EBT may be repeated at varying intervals Your colleagues in beautiful San Diego for the 29th Annual Meeting of the ASMBS. This year’s program will exceed all expectations. Anticipate more collaborative postgraduate courses designed for both the surgeon and the integrated health teams. You’ll see more symposiums, debates and videos. Plan to participate in lively and interactive discussions in both the Integrated Health Main Session as well as the Plenary Session. This year’s Mason Lecturer, Dr. John Birkmeyer, will speak on Composite Measure in Bariatric Surgery, and Basic Science invited lecturer, Dr. Robert O’Rourke, will speak on Obesity Inflammation and Cancer. YoU Don’t WAnt to MiSS it! SEE YoU in SAn DiEgo! Visit www.2012.asmbs.org for more information to achieve durable effect, whilst remaining cost effective compared to surgical alternatives or a lengthy period of pharmacological agents and supervised lifestyle interventions. Training/credentialing Evidence demonstrates that higher quality patient care is associated with high volume bariatric units. Recognition of this prompted the process of credentialing Centers of Excellence in bariatric surgery. The white paper stresses that training and skill acquisition with EBT techniques and technology are mandatory before clinical application is undertaken, and must include didactic as well as hands–on practical education. In addition, any practitioner who is interested in performing an EBT should also be educated in the clinical management of obese patients. The duration and type of training is likely to depend on the complexity of a particular EBT. The ASGE Interactive Training & Technology center (ITT) and Masters Series courses represent appropriate venues for focused training in the procedural aspects of EBT. EBTs of greater complexity may also require proctoring during the first several clinical applications by a new practitioner. EBTs of the highest complexity may require a focused training programme (ie, 'mini-fellowship'), or longer. For all EBTs, early studies should evaluate its learning curve in order to guide the subsequent training and credentialing process. These procedures should be included as a part of a comprehensive obesity programme and not performed in isolation. Cost effectiveness The costs of bariatric surgery and its associated complications may be offset by consequential reductions in weight and obesity-related co-morbidities. However, there are also data to support surgical intervention among Class II and Class I obese individuals with concomitant type II diabetes. Therefore, the TaskForce suggests that elements of a cost effectiveness analysis in EBT include the direct cost of a proposed device and the associated health care utilisation required for its implementation (eg, sedation requirements, time of hospitalisation, physician fees). An EBT which decreases obesity-related co-morbidities for a sustained period of time is likely to reduce long term health care consumption; therefore, accurate data on this secondary outcome are paramount. Additional measures of indirect costs include consequential improvements in quality of life and work productivity secondary to weight loss from an EBT. Therefore, the white paper states that cost effectiveness studies in EBT require long term data on weight loss, obesity-related co-morbidities, impact on quality-of-life, and the possible need for repeated EBT in order to sustain these outcome measures. For these reasons, studies evaluating the cost effectiveness of EBT are expected to be phase III or IV clinical trials. Government and industry relations The white paper also states that the development of EBT should be done in collaboration with government regulating agencies (eg, FDA) to establish thresholds for safety and efficacy (primary and secondary endpoints). While this is a complex process for new devices with widely different risk and efficacy profiles, a clear and transparent process is needed to stimulate development of innovative EBT. The white paper appears online in both GIE: Gastrointestinal Endoscopy, the peer-reviewed scientific journal of the ASGE and Surgery for Obesity and Related Diseases (SOARD), the peer-reviewed scientific journal of the ASMBS. LoDging inforMAtion Rising 30 stories above the edge of San Diego Bay the Hilton San Diego Bayfront hotel is downtown San Diego’s newest waterfront hotel. San Diego Bayfront Hotel 1 Park Boulevard San Diego, California| USA 92101 Tel: +1-619-564-3333 Fax: +1-619-564-3344 Reserve your room now at www.2012.asmbs.org The American Society for Metabolic and Bariatric Surgery designates this educational activity for a maximum of 35.75 AMA PRA Category 1 Credit(s)™ . Physicians should only claim credit commensurate with the extent of their participation in the activity. Nursing Credits (up to 39.25 CE contact hours) are provided by Taylor College, Los Angeles, California (possibly may not be accepted for national certification). APA credits and NASW credits for the ASMBS Masters in Behavioral Health Course are pending approval by Amedco. This course will be co-provided by Amedco and American Society for Metabolic and Bariatric Surgery. 20 BARIATRIC NEWS ISSUE 10 | January 2012 Product News EnteroMedics’ Maestro System gains Australian approval EnteroMedics has stomach. The Maestro RC Sysreceived approval from tem is powered by an internal, the Australian Therapeutic Goods Administration (TGA) of the critical active implantable medical device (AIMD) components of the Maestro System. TGA approval was granted for the Maestro Implant Kit, which is comprised of a rechargeable neuro-regulator, anterior and posterior leads and a clinician transmit coil, as well as the individual implantable rechargeable neuro-regulator component, both of which were AIMD applications. In addition, TGA approved the two class I applications for the AC battery charger and the programmer cable. The TGA is currently reviewing individual class III components, including the mobile charger, multiple versions of the patient transmit coil and the clinician programmer. The Maestro RC System delivers VBLOC vagal blocking therapy via two small electrodes that are laparoscopically implanted and placed in contact with the trunks of the vagus nerve just above the junction between the oesophagus and the rechargeable battery. The battery is recharged via an external mobile charger and transmit coil that the patient uses for a short time each week. EnteroMedics developed VBLOC vagal blocking therapy to offer bariatric surgeons and their patients a less invasive alternative to existing surgical weight loss procedures that may present significant risks and alter digestive system anatomy, lifestyle and food choices. VBLOC Therapy is designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness. “The implantable AIMD components of the Maestro System are the heart of our system and of EnteroMedics' revolutionary approach to obesity treatment. Their approval by the TGA, therefore, marks a major milestone for EnteroMedics and a significant accomplishment for both our company and our many collaborators in the Australian healthcare community,” said Dr Mark B Knudson, En- teroMedics' President and Chief Executive Officer. “The Maestro System is the only surgical intervention to individually address each patient's path toward weight loss without compromises in safety, lifestyle or anatomy. We look forward to completion of the review of the balance of the system components and the opportunity to provide the Australian bariat- Crospon receives FDA clearance for EF-800 accessory Crospon has announced that it has received FDA clearance for its EF-800 external channel endoscopic accessory. The device provides an external 4mm channel that can be applied to a diagnostic or therapeutic endoscope to allow the user to deploy endoscopic accessories whose diameter exceeds the typical channel diameter of such endoscopes. Commenting on the FDA clearance, John O’Dea, CEO of Crospon said, “This general purpose channel may be used to deploy the company’s EndoFLIP catheters into hard to access parts of the gastrointestinal tract, for example for measurement of stomas in the stomach created during bariatric surgery procedures. Equally it will be useful for a variety of other endoscopic accessories, for example larger dilation catheters, graspers or imaging probes.” The company has previously announced FDA clearance to the EndoFLIP EF-900 Gastric Tube. This is intended for use in bariatric surgical procedures to provide a sized support bougie for sleeve gastrectomy, and to permit stomach decompression, gastric fluid drainage and removal. It can also be used to aid deployment of the company’s range of EndoFLIP catheters within the oesophagus and stomach. Medical Center, Dallas, TX. “I use it in all of my gastric sleeve and gastric bypass cases when I need another tissue layer of security. It passes smoothly through tissue like a polypropylene suture with a desirable degree of approximation that’s uniform throughout the suture line.” The V-Loc 180 device, launched in October 2009, was the first surgical device of its kind to feature uni-directional barbed suture technology. The device's unique and proprietary self-anchoring loop and barb combination enables surgeons to close wounds quickly and securely without tying knots or changing standard closure techniques. Since the introduction of V-Loc device technology, surgeons have adopted the product in a wide variety of procedures for secure, fast and effective wound closure. Testing and research indicate that the use of the absorbable V-Loc device technology can decrease the time needed to close surgical incisions by up to 50%, when compared to standard suturing techniques. “With this new addition to our knotless suture portfolio, surgeons have an even broader array of choices for closing surgical incisions safely, quickly and effectively,” said Peter Schommer, Vice President, Global Product Marketing, Wound Closure, Covidien. “We are committed to consistently developing innovative devices to improve patient outcomes, as well as surgeons’ experiences while they operate.” The V-Loc PBT non-absorbable wound closure device has been cleared for one-time use by the United States Food and Drug Administration and is currently available in the US. Covidien launches unique uni-directional knotless suture Covidien has announced the launch of the first non-absorbable, uni-directional barbed suture, part of its range of V-Loc wound closure devices. The V-Loc PBT (Polybutester) non-absorbable wound closure device allows surgeons to securely close incisions without the need to tie knots. Non-absorbable sutures are used to permanently close internal and external wounds. The V-Loc PBT joins the V-Loc 90 and V-Loc 180 absorbable wound closure devices currently available to healthcare professionals. “The V-Loc PBT device allows for accurate oversewing of all staple lines, in both bariatric and general surgery cases,” said Dr David Kim, Forest Park ric care community with a new, safe and sustainable option for addressing the epidemic of obesity in this important market.” BARIATRIC NEWS 21 ISSUE 10 | January 2012 Product News Ethicon launch new powered Laparoscopic stapler Ethicon Endo-Surgery has launched a new laparoscopic stapler, designed to reduce tissue damage through inadvertent movement of the distal tip. The company claims that the Echelon Flex Powered Endopath Stapler allows 63% reduction in tip movement during tissue cutting and stapling, compared to their competitors Covidien’s Endo GIA and Endo GIA Universal devices. According to Ethicon, the new instrument is the first powered endocutter with system-wide compression and stability, delivering a uniform gap in the jaws from the instrument’s proximal end to distal tip, helping the surgeon create consistent, properly formed staples. The powered operation reduces the force required to fire the instrument, leading to less movement of the tip and potentially lower trauma to the patient. Robin Blackstone, Medical Director and Bariatric Surgeon at the Scott- sdale Healthcare Bariatric Center, USA, said of the stapler “I can see how it will be of enormous value in procedures that involve thick tissue and challenging angles.” Ethicon have also announced that they have received 510(K) clearance for their line of Enseal tissue sealers, allowing them to market the instruments in the US. AMI launch new organ retraction system Agency for Medical While organs including the stom- from the operating site. Innovations (AMI) have released a new laparoscopic device for holding organs away from the surgical site during surgery. AMI claim that their EndoSAIL, launched at September’s IFSO meeting in Hamburg, has been designed to provide a safe, atraumatic way to hold organs away from the surgical site during laparoscopic or single-port surgery. AMI intend for the instrument to be introduced through an existing trocar, reducing trauma to the patient. The absence of a rigid retractor also reduces the amount of interference the surgeon suffers from surrounding instruments. Consisting of four instruments, the EndoSAIL combines a singleuse monofilament polypropylene mesh designed to hold organs up hammock-style with a multi-use nickel-titanium alloy introducer. ach, large intestine and mesenterium can be suspended using the device, its intended most common use is to suspend the liver, allowing bariatric surgeons to operate in the upper abdomen. The EndoSAIL kit also comes with a suture catcher, for retrieving the sutures used to suspend the mesh, and a funnel to allow smoother mesh insertion in smaller trocars. In use, the curved EndoSAIL introducer can straighten to enable insertion of the mesh through trocars 5mm or thicker. When the introducer is inside the abdominal cavity, the elastic properties of its alloy allow it to adopt its original shape and properly place the mesh. The triangular mesh can then be secured with the suspension sutures attached to each of its points, allowing the obstructing organ to be secured away AMI also promote the suture catcher as a useful instrument in its own right, allowing surgeons to place and retrieve sutures in other abdominal cavity operations, as well as placing fascial sutures to close larger port-site incisions after laparoscopic surgery. They claim that its 1mm diameter creates less trauma for the patient than similar products. JAiMY 5mm Motorized Articulated Instrument JAiMY is Endocontrol brand new product which is about to revolutionize the world of laparoscopic surgery. Have you ever dreamt of an instrument matching your band movements? Monet had his brushes, surgeons now have JAiMY, the world’s first 5mm motorized instrument for laparoscopic surgery. Operating becomes a real art. What is JAiMY? A handheld motorized articulated instrument designed for the purpose of grasping, retracting, mobilizing, dissecting and suturing of tissues and vessels under endoscopic visualization during surgical procedures. Laparoscopic suturing and knot tying in minimal access surgery is an advanced skill. Mastering this skill is a difficult process, especially when the angle between the needle holder and suture line is unparallel and triangulation is limited. Conventional needle holders just allow for limited movements within the operating field while JAiMY offers fully articulating tip for easy maneuverability and unparalleled access. With the handle, surgeon activates three movements simultaneously: n Full bending of the end effector n Unlimited rotation of the end effector n Opening/closing of the jaws is designed to enable surgeons to overcome the unique challenges presented by single incision and conventional laparoscopic surgery. What is iD intelligent Dexterity? Intelligent Dexterity enables surgeons to extend their hands and to picture movements as if they were inside the patient’s body. Intelligent dexterity is about matching surgeon’s hand movements perfectly for improved efficiency. JAiMY, the first motorized articulating laparoscopic instrument with ID-intelligent Dexterity, NEWS IN BRIEF Gastric bypass reduces blood pressure According to a paper from the Sahlgrenska Academy at the University of Gothenburg, the kidneys play an important role in the regulation of blood pressure by adjusting the production of urine after eating or drinking, which could explain why gastric bypass surgery for obesity also markedly reduce blood pressure. The study includes 1,750 patients who underwent gastric bypass or gastric banding. The results show that the elimination of urine increases after gastric bypass surgery, explained by the fact that food and drink no longer come into contact with the upper part of the digestive tract, thus breaking the link between this part of the digestive system and the kidneys. After ten years the decreased blood pressure following a gastric bypass was not related to the reduced weight and was markedly larger than after gastric banding. The investigators believe that this could be important when deciding between surgical methods for people who are overweight and have high blood pressure. Weight-loss operations up by 50% in three years Bariatric procedures in Scotland have increased dramatically over the last few years, some 309 bariatric surgeries were performed in 2009/10, compared to 203 in 2007/8, an increase of 52%. The rise has been driven partly by the rolling out of the service from five to eight health boards. Moreover, obesity-related deaths in Scotland have increased by more than 40% in a five-year period, with the number of Scots aged 16-64 classed as obese up 10% compared to 15 years ago. With obesity predicted to cost the Scottish economy as much as £3 billion by 2030, advocates of bariatric surgery argue it delivers savings far outstripping the original cost within two or three years. Duff Bruce, Chairman of the Scottish Complex Obesity Treatment Service, said the surgery will become routine within a generation. However, there is also evidence from the figures that cost pressures may already be putting the squeeze on the two health boards which have led the way in providing weight-loss surgery in Scotland. Bruce believes the pattern is driven by a process of ‘rationalisation’ likely to be repeated by other health boards as they too expand the service. Australian position paper for adolescent bariatric surgery n Reusable for improved economics and cost containment. n Provides intelligent dexterity with seven degrees of freedom for unparalleled access, superior tissue manipulation, and easy triangulation in even the most challenging cases. n Benefits to a wide variety of surgical procedures in different clinical specialties, including urology, gynecology, bariatric surgery, general surgery, and cardiothoracic surgery. A position paper from several the Australia nand New Zealand associations has recommended that adolescents should be at least 15 years of age and have a BMI>40 if they are to be eligible for bariatric surgery. They should also have associated complications such as Type 2 diabetes and have persistent problems despite undertaking lifestyle programs. The paper also recommends the creation of a national registry follow adolescent cases as part of National Bariatric Surgery Registry being developed by OSSANZ and the Royal Australasian College of Surgeons. The position paper was published in the December 2011 issue of the ANZ Journal of Surgery. 22 BARIATRIC NEWS ISSUE 10 | January 2012 Calendar of events January 19-20 March 22-25 May 9-12 May June 23-26 BOMSS 3rd Annual Scientific Meeting 2nd Latin America Congress on Controversies to Consensus in Diabetes, Obesity and Hypertension 2012 (CODHY 2012) European Association for the Study of Obesity 19th European Congress 2012 (ECO-EASO 2012) Endocrine Society's 94th Annual Meeting Bristol, UK www: bomss.org February 20-25, 2012 Minimally Invasive Surgery Symposium (MISS) Salt Lake City, Utah www.miss-cme.org Rio De Janeiro, Brazil www: codhy.com/LA/2012 April 11-13 OSSANZ March 7-10 Society of American Gastrointestinal and Endoscopic Surgeons San Diego, CA http://www.sages2012.org/ Darwin, Australia www: ossanz.com.au email: [email protected] April 20 SOBA York, UK www: sobauk.com March 11-14 10th International Anniversary Expert Meeting for the Surgery Obesity and Metabolic Disorders Saalfelden, Austria www: obesity-online.com/expertmeeting April 20-21 Second International Symposium on Non-invasive Bariatric Surgery Lyon, France Phone: 00 33 (0)4 72 01 45 00 Fax: 00 33 (0)4 72 01 45 05 Lyon, France Phone: +44 20 8783 2256 Fax: +44 20 8979 6700 www: easo.org/eco2012 May 23-27 American Association of Clinical Endocrinologists Annual Meeting 2012 Philadelphia, PA http://am.aace.com June 17 - 22 American Society for Metabolic and Bariatric Surgery 29th Annual Meeting San Diego CA www.asmbs.org June 20-23 20th International Congress of the European Association for Endoscopic Surgery (EAES) Brussels, Belgium www.eaes.eu Houston, Texas www.endo-society.org September 11-15 IFSO New Delhi, India www.ifsoindia2012.org September 20-24 Obesity 2012 San Antonio, Texas www.obesity.org 1-5 October European Association for the Study of Diabetes Berlin, Germany www.easd.org October 24-26 The 4th Conference on Recent Advances in the prevention and Management of Childhood and Adolescent Obesity Halifax, Nova Scotia, Canada http://interprofessional.ubc.ca/obesity/ If you would like to place your meeting details here, please email: [email protected] The next issue of Bariatric News is out in March 2012 Editorial deadline: 28 February 2012 Advertising deadline 28 February 2012 If you are interested in submitting an article for the newspaper, please contact the editor of Bariatric News: [email protected] If you are interested in advertising in Bariatric News, please contact our Industry Liaison Manager: [email protected] If you would like to submit press release, please email: [email protected] EDITORIAL BOARD Henry Buchwald BARIATRIC NEWS Editorial and advertising 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. 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