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B ARIATRIC NEWS THE NEWSPAPER DEDICATED TO THE TREATMENT OF OBESITY FOR THE HEALTHCARE PROFESSIONAL IN THIS ISSUE... Nutrition Jacqueline Jacques examines how obesity affects nutritional status. Paul Super and Rishi Singhal offer valuable insights from the Heartlands Lap-Banding programme. 6 Bariatric surgery in… Qatar Bariatric News talks with Michel Gagner to discuss the specialty in Qatar. 8 Coffee Time In this issue we talk with Antonio Torres. 9 Highlights from the 3rd Annual Meeting. 10-13 Obesity Future Highlights from the inaugural meeting. Surgery and adolesence pages 14–15 Consensus panel publishes best practices for LSG Persian Gulf Banding – Tips and tricks A snapshot of Doha 4 India ISSUE 11 | March 2012 16-19 20 An international panel of 25 leading bariatric surgeons has published a consensus paper on the best practices for performing laparoscopic sleeve gastrectomy (LSG). The panel’s recommendations on patient selection, proper surgical technique and prevention, and the management of complications represents the experiences from 24 centres in 11 countries with more than 12,000 sleeve gastrectomy cases. There is a misleading perception amongst surgeons and patients that this procedure is an easy one,” said lead author and panel chairman Dr Raul J Rosenthal, Bariatric and Metabolic Institute and the Cleveland Clinic, FL. “Despite its simplicity, laparoscopic sleeve gastrectomy requires a meticulous technique in order to avoid complications and maximize procedure outcomes. We felt the need to create guidelines to help surgeons prevent complications that are related, in most cases, to the learning curve.” According to the authors, this is the first time an international panel of experts has reached consensus on the best practices for performing laparoscopic sleeve gastrectomy. It is hoped that the consensus statement will help the surgical community continue to improve patient outcomes, minimise complications and move toward adoption of standardised techniques. The consensus paper entitled, ‘International Sleeve Gastrectomy Expert Panel Consensus Statement: Best Practice Guidelines Based on Experience of Over 12,000 Cases’ (Rosenthal et al. SOARD 2012. 8;1; 8-19), was recently published in the January 2012 issue of Surgery for Obesity and Related Diseases, the official journal of the American Society for Metabolic and Bariatric Surgery. Although laparoscopic sleeve gastrectomy (LSG) is a relatively new surgical approach has been readily adopted by surgeons who have embraced the ’simplicity’ of the surgical technique, resolution of co-morbidities and excellent weight loss outcomes. As a result, an international expert panel was convened on March 25 and 26 2011 in Coral Gables, FL, to achieve consen- Q ATA R sus regarding various predetermined aspects of LSG and: (1) conduct discussion and evaluation of various procedural aspects of LSG (inclusive of indications/contraindications, surgical technique, and prevention and management of Qatar SAUDI ARABIA complications) that included and considered the collective experience of participants and current published data; (2) achieve consensus on topics in LSG from the discussion and evaluation; and (3) aid the surgical community and improve the safety of performance with minimal morbidity and high efficacy using the resulting best practice guidelines. Panel data A questionnaire was sent to all panellists before the consensus meeting to compile various data on the total number of LSG cases performed by the group. The total number of LSG cases was 12,799, with mean patient age 42 years of whom 26% were male and 73% female. The mean body mass index of the patients was 44±4.47kg/m2. The mean bougie size was 37F± 5.92F. The average length of hospital stay was 2.5± 93 days and the conversion rate was 1.05%±1.85%. On average, patients experienced a 1.06% Continued on page 3 Is gastric bypass better than banding? According to a six rates following gastric banding. come measures were operative ing (17.2% vs. 5.4%; p<0.001), were still severely obese (BMI The future of obesity treatment 22 CMS and obesity screening 23 Product News 24 Calendar of events 26 year study featured in the Archives of Surgery (published online 16 January 2012) roux-en-Y gastric bypass (RYGBP) is associated with better weight loss, resulting in a better correction of some comorbidities than gastric banding. Although bypass was associated with a higher early complication rate, this was negated much a higher long-term complication and re-operation Lead author, Dr Sébastien Romy, Department of Visceral Surgery, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, and colleagues hypothesised that RYGBP provides superior results compared with gastric banding. To test their theory they recruited 442 patients who were matched according to sex, age, and with a body mass index (BMI) <50. The main out- morbidity, weight loss, residual BMI, quality of life, food tolerance, lipid profile and longterm morbidity, following either RYGBP or gastric banding. Results Follow-up was 92.3% at the end of the study period (six years postoperatively) and the early morbidity was higher after RYGBP than after gastric band- but major morbidity was similar. Six years later, 19% of the bypass patients and 41% of the banding patients reported longterm complications. Weight loss was quicker, maximal weight loss was greater and weight loss remained significantly better after RYGBP until the sixth postoperative year. Three years after surgery, 22% of the banding patients of 35 or greater), compared to 7% of bypass patients and 14% of the banding patients remained morbidly obese (BMI of 40 or greater) after six years, compared to 2.4% of bypass patients. At six years, there were more failures (BMI>35 or reversal of the procedure/conversion) after gastric banding (48.3% vs. 12.3%; P<0.001), more longContinued on page 6 BARIATRIC NEWS 3 ISSUE 11 | March 2012 Consensus panel publishes best practices for LSG Continued from page 1 leak rate and 0.35% stricture rate, with a postoperative gastroesophageal reflux rate reported as 12.11%±8.97%. Patient selection In addition to reaching consensus on LSG as a valid stand-alone procedure (90%), the panellists identified LSG as a valid treatment option for the following categories of patients: patients considered high risk (96%); transplant candidates (kidney and liver) (96%); morbidly obese patients with the metabolic syndrome (91%); patients with a body mass index of 30–35kg/m2 with associated co-morbidities (95%); patients with inflammatory bowel disease (86%); morbidly obese patients in adolescence (77%); morbidly obese patients who are elderly (100%); and patients with Child’s A or B liver cirrhosis (78%). As the first stage of a two-step approach, LSG is only appropriate for the super morbidly obese patient (75%) and that the presence of Barrett’s oesophagus is an absolute contraindication for LSG (81%). Revisions In regards to revision procedures, the panellists agreed that LSG is an acceptable option to convert a successful, but complicated, gastric band (95%). However, it was acknowledged that Roux- en-Y gastric bypass, not LSG, is the best option to convert a failed gastric band (71%). When a patient undergoes conversion from gastric banding to LSG, the operation can be done in one step, which is a valid approach (72%). The two-step approach is also valid (79%). Even assuming that ≤30% of LSG patients will need a second procedure, the panel agreed that it is still an excellent procedure (90%). With regards to staple firings, the last firings (across the thickened site of the previous intervention) should be green or larger (71%). The transection should begin 2–6cm from the pylorus (92%); and it is important to be cautious and maintain a reasonable distance from the gastroesophageal junction on the last firings (96%). Surgical technique The panel achieved consensus on the technical aspects of the performance of LSG, which were summarised as: Sizing the sleeve – in addition to it being important when performing LSG to use a bougie to size the sleeve (100%), the optimal bougie size is 32F–36F (87%). The panel believed that using a bougie <32F might increase complications significantly and that using a bougie >36F could lead to the lack of long-term restriction and possible dilation of the sleeve, resulting in failure of weight loss or long-term weight regain. In addition, in- vaginating the staple line with sutures might result in temporary or permanent reduction of the lumen size (83%), depending on the suture type used (absorbable versus nonabsorbable). Staple heights and firings – consensus was achieved for some points including that it is not appropriate to use staples with a closed height less than that of a blue load (1.5mm) on any part of a sleeve gastrectomy (81%). Although panellists voted against this as they did not agree that anything less than a green load should be used. When using buttressing materials (79%) and when resecting the antrum, the surgeon should never use any staple with a closed height less than that of a green load (2.0mm) (87%), because the gastric antrum wall is the thickest part of the stomach. Mobilisation – it is important to completely mobilise the fundus before transection (96%), otherwise the surgeon could miss a hiatal hernia and leave behind too much stomach, decreasing the restrictive component of the operation. Complications The panel agreed that leaks, strictures, bleeding, and gastro-oesophageal reflux disease were the most prevalent complications observed after LSG. Consensus was reached on several points regarding leaks, including defining leak classifications according to observation periods and can be classified into acute, early, late, and chronic (73%). Additional points of consensus included that the use of a stent is a valid treatment option for an acute proximal leak for which conservative therapy has failed (95%). The use of a stent is a valid treatment option for an acute proximal leak (93%) and an unstable patient with a contained or uncontained symptomatic leak requires immediate reoperation (86%). The panel also made some general observations regarding staple line reinforcement, stating that the use of staple line reinforcement will reduce bleeding along the staple line (100%). Inter- estingly, they could not agree whether to buttress or on whether buttressing reduces leaks. The general points of consensus outside the specific areas of LSG indications, technique, and complications included hiatal hernias and gastro-oesophageal reflux disease. Interestingly, the panel stated that sleeve gastrectomies should only be performed by bariatric surgeons (85%) and that endoscopy should routinely be performed in patients undergoing sleeve gastrectomy (70%). The paper states that the panel reached consensus on almost all topics, providing a basis for current technical and clinical approaches and the development of future guidelines. However, those topics that did not reach consensus (emphasize the need for additional studies and long-term data, especially within the specific areas of staple line reinforcement, patient selection, and specific points about the management of complications. Conclusions The paper concludes by stating that it is not meant to establish a standard of practice merely to support and encourage surgeons and surgical societies to develop standardised guidelines, as well as highlight the areas needing additional study and longterm experience and data. “This type of consensus meeting is, to our knowledge, one of the first aimed at standardizing a surgical technique,” explained Rosenthal. “In these times, when so many new surgical technologies, techniques and procedures are being developed, it is crucial to provide resources for surgeons to learn best practices in a shorter period of time to achieve the optimal procedure results while minimising complications.” The assembly and work of the expert surgeon panel that developed the consensus was supported by an educational grant from Ethicon EndoSurgery (EES). Message from the editor This month’s cover article features the publication on the best practices for laparoscopic sleeve gastrectomy, and includes issues surrounding patient selection, revisions, surgical techniques and complications. Our second cover story highlights a study from Switzerland comparing the outcomes from gastric bypass and banding, which claims the former is associated with better outcomes. We welcome back Dr Jacqueline Jacques, who provides us with an comprehensive overview of how obesity affects nutritional status and Drs Paul Super and Rishi Singhal offer valuable tips and tricks from the Heartlands’ Lap-Banding programme. Bariatric News is also delighted to feature an interview with Professor Michel Gagner who discusses his current bariatric programme in Doha, Qatar. As the IFSO-EC meeting is upon us, in this issue’s ‘Coffee Time’ section we are pleased to feature an in- terview with Professor Antonio Torres, who discusses his achievements, concerns and the future of bariatric surgery. This issue’s ‘Snapshot’ features the city of Mumbai (India) and a study into metabolic syndrome rates that could have implications for the diagnosis of diabetes and obesity. Following the recent British Obesity and Metabolic Surgical Society annual meeting and the London 2012: Future of obesity treatment international sympo, we feature exclusive reports from both conferences. As ever, we also report the latest product news and publish the latest event updates. We hope you find this issue an interesting an 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. If you would like to contact the editor, please email: [email protected] B Subscribe to Bariatric News for FREE ARIATRIC NEWS THE NEWSPAPER DEDICATED 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. I N T H I S I S S U E . . . 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. A snapshot of PROFESSIONAL Bariatric surg cardiovascularery prevents events Vector Created by: Matt Ward/Echo Enduring (c) 2009; Distribut Media - www.ech ed under the Creative oenduring.com Commons lisence. Jacqueline Jacques discusses the nutritional deficiencies in obese and postoperative patients. 4 ASMBSupdatesSGpos ition statement The Association has updated its position on sleeve gastrectomy. 6 CoffeeTime We talk to Professor Philip James about his achievements and the battle against the obesity pandemic. 7 TheHaloeffect According to research, family members of patients who have undergone bariatric surgery have reported weight loss and improvements in their lifestyles. 11 IFSO2011 Patients who unde rgo gastric bypass surgery are less likely more conventional to die from cardi treatment for their ovasc weight condition, (SOS) study. The according to the latest ular events than people who recei research was recen ve tly published in the results from the Swed al. JAMA 2012; 307: Journal of the Amer ish Obese Subjects 56-65). ican Medical Assoc iation Source (Sjos “Bar iaTr ic sUrG trom et ery was associated with about a 30% reduction in the inciden ce of both heart attacks and strokes,” said researc her professor Lars sjostrom, University of Gothen burg, sweden. “while pre-sur gery BMi did not predict surgical health outcomes, having diabetes or risk factors abetes was a strong for diindicator of surgica l benefit. This could have implic ations for selecting candidates for weight loss surgery .” Swedish Obese Subjects The sOs study is an on-going, non-ra ndomised, prospective, controlled study conducted at 25 public surgical departments and 480 primary health care centres in sweden, and include s 2,010 obese particip underwent bariatric ants who surgery and 2,037 matched obese controls who receive d usual care (contro l group). The research is testing the hypothesis that bariatric surgery is associated with criteria were age 37 a reduced inciden to 60 years and a ce of cardiovascular events and examin body mass in- were dex of at least 34 in ing the relationship undertaken at pre-pla men and at least 38 weight change and between gery patient in women. surnned intervals. cardiovascular events. s underwent gastric The average change bypass (13.2 patients were recruit s in body weight after banding (18.7 per ed between septem 2, 10,15, cent), or vertical banded per cent), and 20 years were 23 per and January 2001. ber 1987 ty (68.1 cent, 17 per cent, 16 gastroplas- and The date of analysi per cent), and control per cent, 18 per cent in the s was December s 2009, with median receive surgery group and d usual the swedish primar care in per cent, follow-up of 14.7 0 per cent, 1 y health care system 1 per cent, and 1 per years. inclusion . physical and respect cent in the control biochemical examin group, ively. ations and database cross-checks Complications an Continued on page 3 d costs of bariatri A report from the 2011 IFSO meeting in Hamburg, Germany. 14 EBTwhitepaper A joint TaskForce has released a white paper on endoscopic bariatric therapies ITY FOR THE HEALTHCARE ry 2012 pages 12–13 Nutrition Please send an email to communications@e-dendrite. com stating your full postal address (for a printed copy). TO THE TREATMENT OF OBES ISSUE 10 | Janua 18 Productnews 20 NewsinBrief 21 Calendarofevents 22 According to two recen tly published pape rs in the British Journal of Surgery (October 2011; 98 [10]), long-term complications and further surgery are not uncommon, but despite these disad vantages surgery is a more costeffective way of tackl ing rising morbid obes ity rates than non-operative care. The firsT pape r entitled, ‘Management of late postop erative complications of bariatr ic surgery’ (hamd an et al.) examined the increasing number of patients presen ting to non-specialist units with complications following bariatric procedures and outlined the management of the most common late post- c surgery gestive Diseases Unit at Brighton and Complications sussex University hospitals. “as a reThe most common sult of the current long-term complica, largely ineffective, tions after gastric non-surgical options banding for treating obesislippage (which affects include band ty, the past decade has witnessed an ex15% to 20% of patients) and erosion ponential increase in the number of bar(which can affect up to 4% of patient iatric operations perform s). following gased.” tric bypass, compli Therefore, the researc cations such as interhers under- nal took a literature hernia (5% to 10%), adhesions and search for late postanastomotic stenosi operative operative complications s were found to be that are likely surgery complications after bariatric commo to present to the genera n causes of intestin using pubMed, embas l surgeon. al obstruce, OViD tion. Megao and Google search “in england, there esophagus (dilatio engines, and comare more than n of the esophagus), a rare binations of the 30,000 deaths a year but well reported late terms bariatric surattributed to obesicomplication occurs gery, gastric bypass ty alone, taking an in one in every 200 average of nine years , gastric banding patients after LaGB or sleeve gastrectomy, off a person's normal and hepatobiliary life expectancy,” and late or decomplications were layed complications said the lead author another particular . Only studies with of the paper, conchallenge, the researc follow-up longer than sultant surgeon Mr hers noted. Khaled hamdan, Disix months were included. The study found that functional disContinued on page 4 4 BARIATRIC NEWS ISSUE 11 | March 2012 An Overview of Nutritional Deficiency and Bariatric Surgery 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. As obesity continues to be check not only for anemias, but also for one of the greatest health struggles of our time, bariatric surgery is a valuable therapeutic tool for both the treatment of morbid obesity and associated co-morbid conditions. Regardless of the procedure performed, there are nutritional deficiencies that can occur both pre and post-operatively, and pose a challenge to patient and clinician alike. This article will review the nutritional risks of bariatric surgery and will also touch on the evaluation and prevention of these problems. Pre-Operative Nutrition Studies of bariatric surgery patients presenting for surgery have found significant deficiencies of nutrients. For example, in a 2006 retrospective study of 379 morbidly obese patients, Flancbaum, et al found that 68.1 percent of their patients were deficient in vitamin D, 39 percent were low in iron, 22 percent had low hemoglobin, 8.4 percent had low ferritin, and 29 percent were deficient in thiamine.7 In a 2006 comparison of pre and postoperative nutritional levels in 100 patients, Madan et al found the following deficiency rates before surgery8: n Vitamin A – 11% n Vitamin B12 – 13% n Vitamin D – 40% n Zinc – 30% nIron – 16% n Ferritin – 9% n Selenium 58% n Folate 6% For some nutrients such as vitamin D and Selenium, the nutrient levels were significantly before surgery than they were one year after surgery. A 2008 study by Ernst at al, found the following deficiencies in 232 morbidly obese patients preparing for bariatric surgery9: n Albumin – 12.5% n Phosphate – 8% n Magnesium – 4.7% n Ferritin and Hemoglobin – 6.9% n Zinc – 24.6% n Folate – 3.4% n Vitamin B12 – 18.1% n Vitamin D – 89.7% Researchers looking at individual nutrients have found deficiencies of vitamin D10, thiamine11, vitamin C12 and others. Thus, overall we can clear paint a picture of the morbidly obese patient as having a high incidence of nutritional deficiency. This pre-operative status is important to all forms of bariatric surgery. Regardless of procedure, patients eat less food after surgery, and even with improved dietary intake, it is not possible for those who have had bariatric surgery to get all the nutrition they need from food alone. Deficiencies left untreated can cause acute or chronic problems that can be serious if not addressed. While it may not be cost effective or practical to broadly assess nutritional status prior to surgery, it is becoming increasingly common to common treatable problems such as vitamin D or thiamine deficiency. Increasing our understanding of pre-operative nutrition may lead not only to better overall patient health, but also to predictive models of who may be at greatest risk for early onset of post-operative nutritional deficiencies. We can also start to see that nutritional care of bariatric surgery patients is really a peri-operative issue and not simply a post-operative issue. Nutrition and Adjustable Gastric Banding Because there is no anatomical change to the digestive system with an adjustable gastric band, the risk for nutritional deficiency is clearly lower than with other procedures. With no malabsorption, one primarily needs to be concerned with the ways that fewer calories, dietary changes, and weight loss impact long-term nutrition. Fewer calories means less food. When patients eat less it is simply harder to get all the nutrition they need each and every day. When it comes to dietary changes, most people really improve how they eat after bariatric surgery. But some of the common changes – for example, eating more protein and less carbohydrate – can result in getting less of some key nutrients. Finally, weight loss itself may contribute to some nutritional issues. One good example of this is bone loss. As people lose weight, some bone loss seems to be inevitable. Good nutrition can be used to help reduce the amount of bone that is lost when you lose weight. The following are the primary nutritional concerns after adjustable gastric banding: 1.Thiamine. Thiamine deficiency is an established risk with all types of bariatric surgery. This is because most thiamine deficiency does not occur from malabsorption, but rather from low intake or from vomiting. Current data suggests that the greatest risk is in the first 6 to 12 months after surgery, especially in patients who have vomiting for any reason13. There have been at least two published cases of severe thiamine deficiency (Wernicke’s Encephalopathy) with adjustable gastric bands14,15. 2.B12 and Folic Acid. B12 and folic acid levels have been studied in adjustable gastric band patients in more than one trial. One study of nearly 300 patients examined serum B12, folate and homocysteine16 levels over a two-year period following AGB placement17. The researchers found that those undergoing weight loss had significant elevations of total homocysteine levels compared to controls. Frankly low B12 or folate levels explained 35 % of the elevations. In the remainder of cases, higher than normal levels of these nutrients were required to maintain normal homocysteine levels. Another tive Helicobacter pylori infection, and study conducted in Switzerland, found an 82 percent incidence of gastritis27. Maldigestion due to loss of stomach that by two years following adjustable functions, and malabsorption due to gastric banding, folic acid levels had loss of IF are clear problems. Loss of declined by 44.1%18. 3.Bone Health. When we think about hydrochloric acid, gastric churning, bone, it is important to keep in mind pepsin and IF are all causes of B12 that we have already identified vitamin malnutrition. Both partial and total D deficiency as a common problem in gastrectomy is considered to be a semorbid obesity. The other major nutririous risk for B12 deficiency – this inent for bone health – calcium – is ofcludes gastric bypass, duodenal switch ten a problem when it comes to intake. and gastric sleeves. B12 deficiency is The American Society of Metabolic reported to occur in one-third of postand Bariatric Surgery(ASMBS) recop patients after one year, and may inommendation for calcium intake after crease thereafter depending on nutrigastric banding is 1500 milligrams per tional compliance. Published data after day19. The average calcium intake by RNY estimates a 37 percent deficiency adults aged 35 to 50 years is only 565 rate, though some studies have shown milligrams20. If someone is now eatincidence as high as 70 percent28. ing less after surgery, changes are their 3.Folic Acid. Folate deficiency has been intake has gone down. Studies have found after almost all types of bariatshown evidence of bone loss after gasric surgery. Reported levels of defitric banding. A one-year study found ciency from studies of gastric bypass that there was significant evidence of range from close to 40 percent29 to as low as 1 percent30. Elevated homocysbone loss, especially at the hip21. teine levels (indicative of folate defiNutritional Deficiency ciency) are also reported after all types of procedures31-34 One report suggested and Gastric Bypass Gastric bypass surgery changes the anatthat, deficiency was mostly reflective omy of the digestive system. The stomof compliance with a multivitamin, ach is resected to a small (approximately and this appears to be a reasonable as15mL) pouch, and the entire duodenum sumption based on later data 35. Most of the time, folate is not part of rouplus a distance of approximately 100 to tine labs after weight loss surgery, and 150cm of the jejunum is bypassed. Beit is hard to say at this time if it should cause of this new anatomy, both digesbe. However, due to the special importion and absorption of nutrition form tance folate in pregnancy, it is probafood is altered. As with the Adjustable bly a very good idea for women who Gastric Band, patients have significantwant to have a baby after bariatric surly decreased food intake after gastric bygery to have their folate levels checked pass, as the very small pouch restricts – ideally before becoming pregnant. intake. Additionally, there is altered diLevels might also be checked during gestion. This occurs because most of the pregnancy to assure healthy growth stomach is now bypassed, which means and development of the baby. Bethat food will no longer come in direct cause it is unlikely that folate is malcontact with gastric acid, intrinsic factor absorbed, consuming a daily multivi(required for B12 absorption), or the protamin with 400 to 800 micrograms of tein digesting enzyme pepsinogen. Finalfolic acid should prevent most defily, the bypassed area of the small intesciency. tine allows for malabsorption of some calcium, iron, copper, zinc and several 4.Vitamin D. We have already discussed vitamin D as a significant deficienB-vitamins. Altogether, between pre-excy and comorbidity of obesity. Generisting deficiency, decreased intake, malally speaking, as people lose fat, they digestion and malabsorption, it is untend to improve vitamin D status afavoidable that gastric bypass patients ter surgery in the long run. In studies will be a risk for nutritional problems in comparing pre to post-operative levthe absence of preventive care. els, rates of deficiency tend to decline. The following are the primary nutriFor example, Madan, and colleagues36 tional concerns after gastric bypass surfound that while 40 percent of their pagery: tients were vitamin D deficient prior to 1.Thiamine: As we have already dissurgery, only 21 percent were still vicussed, thiamine deficiency has been tamin D deficient at one year. Similaridentified pre- and post-operatively in ly, Goode and colleagues37 found that bariatric surgery patients. Current data vitamin D in postoperative RNY pasuggests that the greatest risk is in the tients was higher at six months that it first 6 to 12 months after surgery, eswas preoperatively. Generally, the impecially in patients who have vomiting pression results would be confounded for any reason24. Additional risk factors include use of IV glucose withby the fact that all patients undergoout thiamine and parenteral feeding. ing gastric bypass are advised to supPatients who undergo more rapid or plement with vitamin D, so long-term greater-than-expected weight loss may data will eventually be very useful in also be at increased risk. There are reunderstanding how these levels may ports of chronic deficiency as well, aschange over time. Moreover, the apsociated with alcohol intake, lack of parent trend of vitamin D status imsupplementation and onset of poor proving with weight loss should not in eating habits25. Subsequent developany way diminish the fact that this dement of anorexia or bulimia following ficiency is still both common and seriweight loss surgery, would be a signifous in its impact. icant risk for thiamine deficiency, and 5.Calcium. Bone loss and the presence has been reported in literature26. The of metabolic bone disease are well overall incidence of thiamine deficiendocumented after gastric bypass, and cy with gastric bypass is not known, both calcium and vitamin D appear to though it is believed to be low in complay a role in their development. In adparison to others we will discuss. Still, dition to decreased intake, gastric bybecause of its severity and potential pass patients may have their calcium deadliness, it is an important deficienstatus impacted by low stomach acid, cy for clinicians to be aware of. lactose intolerance (possibly reducing 2.Vitamin B12. According to the Amerdairy intake), and malabsorption. In ican Society of Metabolic and Bariata small study measuring calcium abric Surgeons, B12 deficiency occurs sorption with an isotope-labeled calciin around One study in RNY patients um load, Reidt and colleagues38, found that true fractional calcium absorption found a 25 percent incidence of ac- decreased from 0.36 (+/- 0.08) to 0.24 (+/- 0.09) after RNY. This was coupled with an increase in markers of bone turnover. No fewer than four published studies have found decreases in bone mineral density in patients one to ten years post-operative. 6.Iron. Iron deficiency is a common occurrence after gastric bypass. Incidence of deficiency tends to increase over time. Studies cite rates of 16 to 26 percent after one year39. Longer-terms studies have shown incidence as high as 47 percent40. Iron deficiency develops with RNY due to reduced hydrolysis in the stomach coupled with bypass of the primary absorptive surface in the duodenum – in other words there is both malabsorption and maldigestion. Menstruating women and those who become pregnant are at greatest risk. There is also increased risk with those who have problems incorporating meat into their diet, and heavy exercisers. 7.Protein. Protein malnutrition has been reported with RNY, although not commonly. Little is know about overall incidence, as only around eight percent of surgeons track labs such as total protein, albumen or prealbumen41. Limited studies suggest that patients with the most rapid or greatest amounts of weight loss are at greatest risk42. With surgical resection of the stomach, hydrochloric acid43. pepsinogen, and normal churning are all significantly reduced or eliminated. Furthermore, pancreatic enzymes that would also aid in protein digestion are redirected to a lower part of the small intestine. It is thus likely, that maldigestion, rather than malabsorption is responsible for many cases. Some studies have also implicated low intake44. 8.Other Nutrients. There are still many nutrients that have either not been studied in post-operative weight loss surgery patients or that have very minimal data. Some of these include zinc, copper, magnesium, selenium, vitamin B6, vitamin B2, niacin, vitamin A, vitamin E, vitamin K, and essential fatty acids. It is important that clinicians recognize that while there is a known risk of deficiency for some nutrients, this does not rule out the possibility of other deficiencies arising. Thus, it is imperative that those caring for bariatric surgery patients do not simply dismiss symptoms as not having nutritional causes simply because a common nutritional cause has been ruled out. For example, it has already cases of copper deficiency can be missed (and have been missed) when clinicians have ruled out iron and B12 deficiency and fail to continue to look for less common causes of the same symptoms. Vertical Sleeve Gastrectomy There is very limited data available on the impact of the vertical sleeve gastrectomy (SG) on micronutrient status. Currently, there are a handful of short-term follow up papers, which shall be discussed here. Most literature refers to SG as a purely restrictive procedure (since it is limited to surgical alteration of the stomach), which may give the impression that there should be minimal impact on vitamins and minerals – similar to gastric banding. However, the position statement from the ASMBS notes that, “The mechanisms of weight loss and improvement in co-morbidities seen after SG might be related to gastric resection, neurohormonal changes related to gastric restriction or gastric emptying, or some other unidentified factor or factors.”45 Because vitamin and Continued on page 6 BARIATRIC NEWS 5 ISSUE 11 | March 2012 Non-invasive bariatric techniques and novel approaches Editorial from Jerome Dargent (Lyon, France) Our second “Non-Invasive bari- atric surgery and new technologies” Meeting in Lyon is announced for April 20-21, 2012. It will be an honour to co-chair this meeting with the former president of IFSO, Karl (“Charlie”) Miller, who hosts an annual expert meeting in the Austrian Alpes, that few key-opinion leaders actually miss. Like last year, we will cover the current topics of the ongoing clinical research in this field. Tremendous updates will be presented on SILS, neuromodulation, NOTES, endo-jejunal bypass, endoscopy for bypass failures, etc. Brand new and highly promising procedures will be highlighted together, and for the first time submitted to a benchmarking process, and scrutinized by the prestigious Australian surgeon Paul O’Brien, or put into the “Asian perspective” by the Indian leader Pradeep Chowbey. Let us cite: the balloon that can be swallowed, the re-shape balloon, the Full Sense restrictive device, the “loaded” microinstrumentation or the powered stapler and needle-holder, and many others. A vast portion of the obese population does not take advantage from the surgical possibilities, which is the reason why clinical research should be oriented towards less invasive procedures that could be accepted by the mainstream. The Noninvasive bariatric techniques are not standardized and sufficiently assessed in 2012, but they are being constantly upgraded. The programme has been divided into five parts: 1. Procedures that aim at lowering the ” surgical trauma “, mostly the single-trocar and the NOTES approaches. Do we have the instruments we need? Is the upgrade relevant versus the typical lap-approach? 2. Techniques that are available through ” natural orifices “, the most promising provided, if can prove satisfactory and long-standing. 3. New technologies, like neuromodulation. 4. Transversal issues: the role of the anesthesiologist, the cooperation of the gastro-enterologist, etc. 5. Guide-lines for the forseeable evolutions. Surgical procedures that are well established (gastric bypass, adjustable band, sleeve gastrectomy) will not be addressed as such, but only from the perspective of comparison and confrontation with less invasive procedures. The programme shall evolve during the forthcoming weeks. Please check again in order to get the updates! Friday 04/20/2012, 8:30 am, till 6:00 pm Saturday, 04/21/2012, 8:30 am till 1:00 pm Training sessions are scheduled with non-edited videos I. Preliminaries: Welcome address, toward the future! Karl Miller (Austria) and Jerome Dargent (France) Benchmarking of novel technologies in bariatric surgery, can we establish guide-lines? Paul O’Brien (Australia) II. Mixt and original techniques, state of the art nNOTES-inspired Sleeve Gastrectomy (transvaginal), a failure? Elie Chouillard (France) n A camera integrated in a magnetic internal mechanism (MIM) for single access laparoscopy, application in bariatric surgery: Nicola di Lorenzo (Italy) nRoutine gastric banding through the SILS approach: Marie-Cécile Blanchet (France) n Bariatric SILS for everyone: a field experience: Jean Cady (France) n SILS, critical considerations: Karl Miller (Austria). n Shall micro-instrumentation take over SILS: Gilles Poncet (France) and Maud Robert (France), (non-edited video). nGastric plication: the sleeve killer, Elie Chouillard (France), (non-edited video). III. Purely Non-invasive techniques nRevision of failed bariatric surgery/gastric bypass: Endoscopic rescue after obesity surgery: what are the needs and expectations of the bariatric surgeon in 2012? / Strategy for therapeutic sequences in bariatric surgery, including Non-invasive and new technologies: Jacques Himpens (Belgium) nThe endoscopic treatment of post-op complications after bariatric surgery (bleeding, leaks, stenosis): Elisabeth Mathus-Vliegen (The Netherlands) n Primary restrictive endoluminal procedure for obesity, overview: Jacques Deviere (Belgium) nThe G-prox “ROSE” and “POSE” for morbid obesity and re-do. Current experience: Gontrand Lopez-Nava (Spain), Tom Lavin (USA) Non-edited videos nThe Barosense Teris device, an endoscopic band? Elisabeth Mathus-Vliegen (The Netherlands) nEndoscopic stapling, TOGa: technique and results: Jacques Deviere (Belgium) n Satiety Inducing-Full Sense Device for obesity: Randal Baker (USA) n Stents for staple-line leaks (sleeve gastrectomy): Rudolf Weiner (Germany) nThe TRIM procedure for obesity: Stacy Brethauer (USA) nInjection at the GE junction: Jérôme Dargent, Frédéric Pontette (France) nIntra Gastric Balloon placement, removal, and state of the art: Zbigniew Kowalczyk (Poland) nEvaluation of several types of balloons: Elisabeth Mathus-Vliegen (The Netherlands) nResults of the adjustable gastric balloon: Christophe Bastid (France) nThe Gastric Balloon that can be swallowed, feasibility trial: Frédéric Mion (France) nThe duodeno-jejunal bypass sleeve: a novel approach for type 2 diabetes: Jan Greve (The Netherlands) III. Novel technologies and combined issues nEvolution and perspective of neuromodulation in obesity treatments: Scott Shikora (USA) nGastric neuromodulation with the V-BLOC system: Karl Miller (Austria) nGastric neuromodulation with the TANTALUS system: Rudolf Weiner (Germany) nGastric neuromodulation with the ABILITI system: Thomas Horbach (Germany) nThe position of the anaesthesiologist: 1. Less invasive approach for anaesthesia in the obese patient: Jan Mulier (Belgium) nThe position of the anaesthesiologist: 2. Anaesthesiology for Non-invasive bariatric surgery: Sinha Ashish (USA) nThe cooperation between the bariatric surgeon and the endoscopist: Elisabeth Mathus-Vliegen (Nederlands) n An original approach for the follow-up through modern communication systems: Maxime Sodji (France) nThe choice of a metabolic operation in Eastern-Asia, new technologies and cost-effectiveness, an economic perspective: Pradeep Chowbey (India) V. Panel sessions Session n°1, chaired by Karl Miller: Surgical approaches in bariatrics. Non-invasive procedures vs. NOTES vs. single trocar or micro-instrumentation? Session n°2, chaired by Paul O’Brien: What main concept will emerge concerning purely Non-invasive techniques? Based on our meetings, a “Directory of Non-invasive and new technologies in bariatric surgery” will be edited at Springer-Verlag by summer 2012. 6 BARIATRIC NEWS ISSUE 11 | March 2012 An Overview of Nutritional Deficiency and Bariatric Surgery 14.Bozbora A, Coskun H, Ozarmagan S, Erbil Y, Ozbey N, Orham Y. A rare complication of adjustable gastric banding: Wernicke’s encephalopathy. Obes Surg. 2000 Jun;10(3):274-5. Aarts found substantial deficiency in mineral status can be adversely impacted their post operative SG patients. Howin the absence of malabsorption, it is not ever vitamin D deficiency is only a risk surprising that even the limited available for, and is not confirmation of changdata begins to indicate some challenges. es to bone. A small study from Spain 1.B12, Folate and Iron. Perhaps in an compared both blood chemistries and effort to compare against Roux-en-Y bone density findings in SG patients gastric Bypass (RNY), we have ear(n = 8) to gastric bypass patients (n = ly data that predominantly focuses 7). Pre-operative data was compared to on vitamin B12, folic acid and Iron. post-operative data. Both groups were Hakeam et al46 followed 61 SG pafound to have similar losses of bone at tients for one year. Patients were not all areas measured, though it was gentaking vitamins. Over the course of erally somewhat less in the SG group. the study, 4.9% of the patients develSleeve patients lost 4.6%±4.4 in the oped iron deficiency anemia, 18.1% lumbar spine, 8.3%±5.2 in the femoral of patients developed new B12 defineck, 7.1%±3.7 in the total hip meaciency (8.1% had B12 deficiency besurement, 0.2%±9.3 in the proximal fore surgery, 26.2% at the end of one radium and 3.2%±6.3 in the distal rayear), and 9.8% of patients developed dius. Vitamin D levels were found to new onset folate deficiency. Toh, et al47 increase after surgery, as did N-telocompared pre-op data to one-year data peptide and bone alkaline phosphain 11 SG patients and found that 15% tase. Thus, while this was a very small had low hemoglobin and 25% had elsample size, we have an indication that evated homocysteine at the conclusion increased bone loss and turn over are of 12 months. Aarts et al48 studied 60 likely and should be monitored. SG patients for one year. Patients were 3.Other Nutrients. Available data on othinstructed to take a multivitamin with er nutrients is minimal. Toh47 found vitamin D deficiency in 43% of SG pa150% of then RDA three times daily tients at one year. Aarts4 found vitamin (exact contents unknown). At the end D deficiency in 39% of study particof one year, 26% of patients had aneipants and low albumin in 15%. The mia, 43% had iron deficiency, 15% had same study also found elevated levfolic acid deficiency, and 9% had B12 els of vitamin A, B1 and B6. The audeficiency. Finally, Gerher et al49 provided 3-year data in 50 SG patients. thors suggest that these elevations Patients in this study we all instructed were most likely due to supplementato take a standardized multivitamin* tion, but since the contents of the proddaily. At the end of the study, 18% of uct being taken was not disclosed, the patients had iron deficiency, 18% had levels and forms of these nutrients that B12 deficiency, and 22% had folate created these results are unknown. deficiency. Gehrer49 found low levels of zinc, vitamin D, and albumin at three years. 2.Bone Loss. Evidence for bone loss with There is also a single published case non-surgical weight loss and all other report of an acute thiamine (B1) deficommon forms of surgical weight loss, ciency (Wernicke’s encephalopathy) so one would not expect SG to be imin a patient with vomiting due to stricmune. We already know that vitamin ture50. D deficiency is very common before 51 bariatric surgery , and both Toh and levels with weight loss after Lap-Band surgery: higher folate and vitamin B12 levels required to maintain homocysteine level. Int J Obes Relat Metab Disord. 2001 Feb;25(2):219-27. 15.Homocysteine is a substance in the body that increases when there is not enough folate and/or B12. High homocysteine is a risk for heart disease and other conditions. 35.Brolin REGorman JH, Gorman RC, Petschnik AJ, Bradley LJ, Kenler HA, Cody RP. Are vitamin B12 and folate deficiency clinically important after roux-en-Y gastric bypass? J Gastrointest Surg. 1998 Sept-Oct;2(5):436-42. Continued from page 4 Conclusions Nutritional care is an important part of the long-term health of all weight loss surgery patients. All bariatric surgery procedures create some new risk for deficiency that is over and above pre-operative deficiency. It is important for any practitioner caring for bariatric surgery patients to establish education, nutritional protocols, and guidelines for follow-up laboratory testing. Clinicians caring for bariatric surgery patients should have a good understanding of the common potential problems and be aware of less common deficiencies that can occur. Perhaps one of the most successful gastric banding programmes in the UK is in Birmingham. Bariatric News catches up with the Heartlands Hospital Unit where 75% of weight loss surgery patients receive bands. Pre-operative preparation Pre-op dieting is imperative. We favour meal replacement shakes and yogurts (1000kcal diet) for this pre-operative period. BMI 40-50 have this diet for 2 weeks, 50-60 for 4 weeks and BMI greater than 60 for 2 months. Day of Surgery All patients are admitted on the day of surgery and when ready, walk to theatre. No pre-op anticoagulation is given. Port size is kept to a minimum (12mm, 10mm, and three 5mm dilating trochars). Dissection Early band infection and erosion are undoubtedly secondary to surgical trauma and micro-perforation occurring during dissection. All dissection should be gentle with careful tissue handling. All dissection in our practice is carried out with simple hook diathermy. A 2cm vertical incision is made in the myomesium over the medial border of the right crus to 17.Dixon, et al. Elevated homocysteine levels with weight loss after Lap-Band surgery: higher folate and vitamin B12 levels required to maintain homocysteine level. Int J Obes Relat Metab Disord. 2001 Feb ;25(2): 219-27. 36.Madan AK, Orth WS, Tichansky DS, et al. Vitamin and trace mineral levels after laparoscopic gastric bypass. Obes Surg. 2006 May;16(5):603-6. 37.Goode LR, Brolin RE, Chowdhury HA, Shapses SA. Bone and gastric bypass surgery: effects of dietary calcium and vitamin D. Obes Res. 2004 Jan;12(1):40-7. 18.Gasteyger C, Suter M, Calmes JM, Gaillard RC, Giusti V. Changes in body composition, metabolic profile and nutritional status 24 months after gastric banding. Obes Surg. 2006 Mar;16(3):243-50. 38.Riedt CS, Brolin RE, Sherrell RM, Field MP, Shapses SA. True fractional calcium absorption is decreased after Rouxen-Y gastric bypass surgery. Obesity (Silver Spring). 2006 Nov;14(11):1940-8. 19.Aillis L, Blankenship J, Buffington C, Furtado M, Parrott J. ASMBS Allied Health Nutritional Guidelines for the Surgical Weight Loss Patient. Surgery for Obesity and Related Diseases. 2008 May: 4(5): S73-S108. 39.Brolin RE, Leung M. Survey of vitamin and mineral supplementation after gastric bypass and biliopancreatic diversion for morbid obesity. Obes Surg. 1999 Apr;9(2):150-4. 20.USDA National Food Consumption Survey 1988 40.Brolin RE, Gorman RC, Milgrim LM, et al. Multivitamin prophylaxis in prevention of post-gastric bypass vitamin and mineral deficiencies. Int J Obesity 1991;15: 661-7. 1. Ohrvall M, Tengblad S, Vessby B. Lower tocopherol serum levels in subjects with abdominal adiposity. J Intern Med 1993;234:53±60. 21.Giusti V, Gasteyger C, Suter M, Heraief E, Gaillard R, Burckhardt P. Gastric banding induces negative bone remodelling in the absence of secondary hyperparathyroidism. Int J Obes Relat Metab Disord. 2003 Jan;27(1):1106. 41.Updegraff TA, Neufeld NJ. Protein, iron, and folate status of patients prior to and following surgery for morbid obesity. J Am Diet Assoc. 1981;78(2):135–140. 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. 22.Flancbaum L, Belsley S, Drake V, et al. Preoperative nutritional status of patients undergoing Roux-en-Y gastric bypass for morbid obesity. J Gastrointest Surg. 2006 JulAug;10(7):1033-7. 42.Segal A, Kinoshita Kussunoki D, Larino MA. Postsurgical refusal to eat: anorexia nervosa, bulimia nervosa or a new eating disorder? A case series. Obes Surg. 2004;14(3):353–360. 3. Madan AK, Orth WS, Tichansky DS, et al. Vitamin and trace mineral levels after laparoscopic gastric bypass. Obes Surg. 2006 May;16(5):603-6. 23.Vemulapalli P, McGinty A, Lopes J, Goodwin A, Teixaira J. Nutritional Deficiency in Laparoscopic Gastric Banding. ASMBS 2004. 4. Flancbaum L, Belsley S, Drake V, et al. Preoperative nutritional status of patients undergoing Roux-en-Y gastric bypass for morbid obesity. J Gastrointest Surg. 2006 JulAug;10(7):1033-7. 24.Singh S, Kumar A.cmE Wernicke encephalopathy after obesity surgery: A systematic review. Neurology 2007 Mar 13;68(11):807-11. 43.Behrns KE, Smith CD, Sarr MG. Prospective evaluation of gastric acid secretion and cobalamin absorption following gastric bypass for clinically severe obesity. Dig Dis Sci. 1994 Feb;39(2):315-20. References 5. Kimmons JE, Blanck HM, Tohill 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. Flancbaum L, Belsley S, Drake V, et al. Preoperative nutritional status of patients undergoing Roux-en-Y gastric bypass for morbid obesity. J Gastrointest Surg. 2006 JulAug;10(7):1033-7. 8. Madan AK, Orth WS, Tichansky DS, et al. Vitamin and trace mineral levels after laparoscopic gastric bypass. Obes Surg. 2006 May;16(5):603-6. 9. Ernst B, Thurnheer M, Schmid SM, Schultes. Evidence for the necessity to systematically assess micronutrient status prior to bariatric surgery. Obes Surg 2009 May; 19:66-73. 10.Buffington C, Walker B, Cowan GS Jr, Scruggs D. Vitamin D Deficiency in the Morbidly Obese. Obes Surg. 1993 Nov;3(4):421-424. 11.Antozzi P, et al. Thiamine deficiency in an obese population undergoing laparoscopic bariatric surgery. Surg for Obes and Rel Dis. 2005 May:1(3): 264-65. 12.Riess KP, Farnen JP, Lambert PJ, Mathiason MA, Kothari SN. Ascorbic acid deficiency in bariatric surgical population. Surg Obes Relat Dis. 2009 Jan-Feb;5(1):81-6. Epub 2008 Jul 9. 13.Singh S, Kumar A.cmE Wernicke encephalopathy after obesity surgery: A systematic review. Neurology 2007 Mar 13;68(11):807-11. Tips and Tricks in Successful Lap Band Insertion Paul Super, Rishi Singhal Heart of England NHS Foundation Trust, Birmingham, UK 16.Solá E, Morillas C, Garzón S, Ferrer JM, Martín J, Hernández-Mijares A. Rapid onset of Wernicke’s encephalopathy following gastric restrictive surgery. Obes Surg. 2003 Aug;13(4):661-2. 25.Grace DM, Alfieri MA, Leung FY. Alcohol and poor compliance as factors in Wernicke’s encephalopathy diagnosed 13 years after gastric bypass. Can J Surg. 1998 Oct;41(5):389-92. 26.Bonne OB, Bashi R, Berry EM. Anorexia nervosa following gastroplasty in the male: two cases. Int J Eat Disord. 1996 Jan;19(1):105-8. 27.Renshaw AA, Rabaza JR, Gonzalez AM, Verdeja JC. Helicobacter pylori infection in patients undergoing gastric bypass surgery for morbid obesity. Obes Surg. 2001 Jun;11(3):281-3. 28.Brolin RE, Leung M. Survey of vitamin and mineral supplementation after gastric bypass and biliopancreatic diversion for morbid obesity. Obes Surg. 1999 Apr;9(2):150-4. 29.Halverson JD. Micronutrient deficiencies after gastric bypass for morbid obesity. Am Surg. 1986 Nov;52(11):5948. 30.Mallory GN, Macgregor AM. Folate Status Following Gastric Bypass Surgery (The Great Folate Mystery). Obes Surg. 1991 Mar;1(1):69-72. 31.Sheu WH, Wu HS, Wang CW, Wan CJ, Lee WJ. Elevated plasma homocysteine concentrations six months after gastroplasty in morbidly obese subjects. Intern Med. 2001 Jul;40(7):584-8. 32.Brolin RE, Leung M. Survey of vitamin and mineral supplementation after gastric bypass and biliopancreatic diversion for morbid obesity. Obes Surg. 1999 Apr;9(2):150-4. 33.Hocking MP, Davis, GL, Franzini DA, Woodward ER. Longterm consequences after jejunoileal bypass for morbid obesity. Dig Dis Sci. 1998 Nov;43(11):2493-9. 34.Dixon JB, Dixon ME, O’Brien PE. Elevated homocysteine pulled well below the band). Gastric Fixation (tunnellating) sutures. We firmly believe that gastric fixation sutures are extremely important to prevent slippage and to ensure an optimal sized micro-pouch. We use three such sutures, all of which plicate some of the fundus below the band which is brought up over the band to the left crus (1st stitch; ‘Birmingham’ stitch) and pouch (2nd and 3rd stitch)[1]. Elimination of slippage by surgical technique will as a consequence significantly reduce the risk of late Figure 1. A scatter plot of logit erosion versus logit slippage for 19 studies reporting erosion which is sometimes seen outcomes after gastric banding that had a minimum of 500 patients and a 2-year many years later. Research carfollow-up period [2]. ried out in our unit demonstrates this association (figure 1). reveal the muscle surface. The prolapse is more likely to occur peritoneal reflection of the angle through the band where there is a Attention to tubing and Port of His is taken down to reveal the hiatus defect above the band. The Position left crus. A similar 2cm vertical repair can be anterior hiatoplasty, Paying attention to detail towards incision made in the myomesi- posterior crural repair or a combi- the end of the procedure has a large influence on such matters as port um over the left crus. A retro-gas- nation of both. rotation, tubing fracture and port tric dissector now passes easily in infection. We always re-prep the front of both crura via the open- Delivery of band ings made in the muscle sheaths, The band is delivered into the ab- skin with disinfectant at this point. so producing a tight posterior domen via the 12mm port. Most The band tubing should be delivtunnel for the band and prevents band types when empty will pass ered through the abdominal wall posterior gastric prolapse. This via a 12mm port. The band is fas- via a 10mm port site. 3 or 4 nonalso means that when the band is tened over the perigastric fat pad absorbable sutures are placed on delivered, there is an additional which is never resected. Units the sheath and the port fastened to tissue layer protecting the poste- where excision of the fat pad is the rectus sheath port wound close rior gastric wall from trauma dur- routine have a measurable early to the 10mm tubing exit wound. infection and erosion rate prob- This facilitates easy replacement of ing traction of the band. able due to trauma during this the tubing into the abdomen. When Hiatus hernia repair manoeuvre. Where the fat pad is the adjustment port is attached to Not infrequently a sliding hia- very large, we would always ad- the tubing it is extremely importus hernia is encountered and vocate a large size band and fix- tant to remove any axial twist in this must be repaired as gastric ation high on the fat pad (fat pad the tubing so that there are no ax- ial forces on the port which we believe is the most common reason for subsequent port rotation. In band types with a metal connector, care must be taken to avoid angulation of this section in the abdominal wall which would produce tubing rupture 1-2 years later. Wound Closure Heamostasis should be secured before closure – a detail which probable reduces early wound infection. Discharge from Hospital Early mobilization is encouraged by same day discharge in more than 50% of our patients. Insulin treated diabetics and those suffering sleep apnoea stay overnight. 40mg Enoxaparin is administered 2 hours post op and daily whilst in hospital. Follow-up Lifelong follow-up needs to be available and a team is required to deliver this. Too tight a band will eventually result in oedema and over-restriction, with an increased risk of pouch dilatation and gastric wall prolapse. Having a low threshold for radiology will help in early detection of band related complications should they still develop. References 1.Singhal R, Kitchen M, Ndirika S, Hunt K, Bridgwater S, Super P (2008) The "Birmingham stitch"-Avoiding Slippage in Laparoscopic Gastric Banding. Obes Surg 18:359-363 2.Singhal R, Bryant C, Kitchen M, Khan KS, Deeks J, Guo B, Super P Band slippage and erosion after laparoscopic gastric banding: a meta-analysis. Surg Endosc 24:2980-2986 44.Moize V, Geliebter A, Gluck ME, et al. Obese patients have inadequate protein intake related to protein intolerance up to 1 year following Roux-en-Y gastric bypass. Obes Surg. 2003;13(1):23–28. 45.Clinical Issues Committee of the American Society for Metabolic and Bariatric Surgery Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis. 2010 Jan-Feb;6(1):1-5. Epub 2009 Nov 17. 46.Hakeam HA, O'Regan PJ, Salem AM, Bamehriz FY, Eldali AM. Impact of laparoscopic sleeve gastrectomy on iron indices: 1 year follow-up. Obes Surg. 2009 Nov;19(11):1491-6. Epub 2009 Jul 15. 47.Toh SY, Zarshenas N, Jorgensen J. Prevalence of nutrient deficiencies in bariatric patients. Nutrition 2009 NovDec;25(11-12):1150-6. Epub 2009 May 31. 48.Aarts EO, Janssen IM, Berends FJ. The gastric sleeve: losing weight as fast as micronutrients? Obes Surg. 2011 Feb;21(2):207-11. 49.Gehrer S, Kern B, Peters T, Christoffel-Courtin C, Peterli R. Fewer nutrient deficiencies after laparoscopic sleeve gastrectomy (LSG) than after laparoscopic Roux-Y-gastric bypass (LRYGB)-a prospective study. Obes Surg. 2010 Apr;20(4):447-53. Epub 2010 Jan 26. 50.Makarewicz W, et al. Wernicke’s Syndrome after Sleeve Gastrectomy. Obes Surg. 2007 May;17(5):704-6. 51.Mahlay NF, Verka LG, Thomsen K, Merugu S, Salomone M. Vitamin D status before Roux-en-Y and efficacy of prophylactic and therapeutic doses of vitamin D in patients after Roux-en-Y gastric bypass surgery. Obes Surg. 2009 May;19(5):590-4. Epub 2008 Oct 11. Bypass vs. banding Continued from page 1 term complications (41.6% vs. 19%; p<0.001) and more reoperations (26.7% vs. 12.7%; p<0.001) after gastric banding. In conclusion, the authors said “At the present time, Roux-en-Y gastric bypass seems clearly superior to gastric banding when treating morbidly obese patients.” However, in a press release, Allergan, who market the Lap-Band gastric banding system, said that the study included ’specific weaknesses’ including: n Patients receiving an older version of the banding system (which is no longer used) and an outdated insertion method was used which has also been replaced since the patients in the study had the procedures; and n A failure by the researchers to include many complications that have been associated with bypass surgery in their analysis, including small bowel obstructions, osteoporosis, anaemia and long-term nutritional complications. “Although we applaud the high sixyear follow-up rate of these bariatric patients, it would be inappropriate to draw conclusions regarding the relative risks and benefits of either procedure based on this single study,” Allergan said in the statement. Advert 8 BARIATRIC NEWS ISSUE 10 | January 2012 Bariatric surgery in…Qatar Michel Gagner On November 14th 2011, the International Diabetes Federation launched the 5th edition of the ‘Diabetes Atlas’ to coincide with World Diabetes Day. The new figures indicate that the number of people living with diabetes is expected to rise from 366 million in 2011 to 552 million by 2030. Nowhere is the increased expected to be more marked than in the Middle East and North Africa Region. Currently, 32.6 million people (9.1% of the population) have diabetes and this number is expected to double in less than 20 years. By 2030, 59.7 million people (11% of the population) will be living with diabetes with more millions undiagnosed. Moreover, six out of the world’s top ten countries with the highest prevalence of diabetes are in the region. The new regional figures also show that the prevalence of type 2 diabetes in the region for younger age groups is substantially higher than the global average. Qatar and obesity According to International Association for the Study of Obesity’s 2012 statistics, Qatar ranks sixth globally in the prevalence of obesity and has the highest rate of obesity (36.5%) among boys (and 23.6% of girls) aged 12–17 Qatar is also ranked 5th for having the highest percentage of people between 20 and 79 with diabetes. Currently 16% of the population is diabetic. The Hamad Medical Corporation (HMC) is the premier non-profit healthcare provider in Doha, Qatar. The HMC has an expressed mission to provide the best quality care for all patients irrespective of nationality, in order to create ‘Health For All’ healthcare programme, as pledged by the State of Qatar. Providing a ‘Health For All’ healthcare programme has resulted in a huge investment in all areas of public health, including diabetes and obesity. Part of the fight against these debilitating condition will be by a team of bariatric surgeons and specialists at HMC, headed by Dr Michel Gagner (Professor of Surgery in Montreal, Canada). “I first came to Qatar when I was Chief of laparoscopic Surgery at Cornell University in New York (2003-07), and I was invited by Dr Abdulazim Abdul Wahab Hussain (now Consultant General Surgeon and Medical Director of Al-Ahli Hospital in Doha, Qatar) to assist him with complex cases. I was visiting Qatar two or three times each year,” explained Gagner. “After Dr Hussain left HMC, the hospital was looking to re-engineer the bariatric programme and I arrived in February 2011 with the objective of re-establish the HMC’s bariatric programme as a centre of excellence in the region.” There are many reasons for such high rates of obesity in the country including a lack of exercise and poor diets, as well as cultural traditions. “Lifestyle choices have the greatest impact on a patient’s health. We need to educate the population on the consequences of not exercising regularly and inform people of the dangers of eating foods that are high in calories and carbohydrates, and of the benefits of eating fruits and vegetables,” he said. “These choices are more influential than a person having genetic pre-disposition to obesity.” There are also cultural influences as in Qatari society food is often consumed communally, making it difficult to ensure proper portions and it is also perceived as normal within society to be obese, with no stigma associated with obesity. In the 18 months Gagner has been operating in Qatar, the HMC team have managed to train local surgeons and specialised bariatric team to perform several bariatric procedures. In fact, the HMC team have performed over 500 procedures with a zero mortality rate. With obesity and diabetes rates some of the highest in the world, he argued that the population required and deserved a dedicated bariatric programme. “In our team there is one senior consultant, one junior consultant, a specialist with a couple of finishing general surgery residents, who are probably going to join the bariatric programme. We are not the only hospital in the region performing bariatric surgery, but I believe we are performing more complex cases, such as revisions.” Different procedures As well as a lack of education and awareness of the causes of obesity, he acknowledged that there is also a general lack of education in the general population about obesity and in particular bariatric surgery. As a result, most people thought that the Lap-Band was the procedure of choice however, the procedure does have a high rate of failure in the region due to poor patient compliance (poor exercise and dietary compliance results in the patient returning to hospital to have their band adjusted). “As a result, each day we removed bands as they just do not have the desired effect. The patients eat a lot, become ill and have regained Persian Gulf Doha QATA R Qatar SAUDI ARABIA weight,” he explained. “Therefore, there has been a big change in the types of procedures we perfrom. I think in the last year there have been two Lap-Band procedures the rest were either bypass or sleeve gastrectomy. In fact, over the last few months we have seen more sleeve than bypass procedures.” Sleeve gastrectomy is preferred due to the compliance of the patient to the post procedure regime. Bypass requires supplements and patients do not always stick to this regime, whereas sleeve the intestine routing is not affected and mineral absorption stays the same. Gagner explained that there is also the consideration of pregnancy. “If young women are planning a pregnancy in the future then bypass will reduce the amount of folic acid produced and could cause certain neurological deficiencies for the child so we would strongly advise against bypass.” Although sleeve gastrectomy can cause some vitamin 12 deficiencies in certain cases, it does not have a detrimental effect on the mother or child. He emphasized that there is a lot to do in terms of educating the patients in regard to other types of bariatric procedures, the associated risks and complications (leaks and bleeding), as well as dietary, exercise and other life-style changes required. “We have to make patients aware that although bariatric surgery can resolve metabolic problems such as diabetes, if they do not comply with their dietary regime they may develop micro-nutrient deficiencies (iron, calcium),” said Gagner. “There is also need to create and develop bariatric patient support groups so they can help each other before and after surgery, as well as the more general need to educate the public about the importance of regular exercise.” Children Of course bariatric surgery for children should be a last resort, but Gagner described a vicious cycle in which adolescents unable to lose weight become withdrawn, trapped, bullied, do not play with other children, spend more time on computers and less time exercising. “When we speak about bariatric surgery for children, then we have an obvious problem,” he lamented. “More needs to be done to address children’s consumption of breakfast cereals, snack foods, dairy products, carbonated beverages, chilled desserts and restaurant foods.” Registry There are currently over 1,000 patients on the waiting list for bariatric surgery at the HMC and given the volume of procedures, the HMC is looking at collecting patients’ data in a clinical database that will be populated through monitoring their outcomes, treatment efficacy, safety and complications. “We are looking to employ a registry in Qatar similar to the one utilised by bariatric surgeons in the UK. This was a well designed and developed database that permitted surgeons to collect their data prospectively. If we were to adopt such a system it would allow us to identify outcomes, complications and failures and see how we could improve,” he added. “We could also match our outcomes with the UK data and see how we compare. There is also the possibility of putting the data into a larger international registry and see how bariatric surgery in Qatar compares country to country and region to region, to the benefit of surgeons and patients.” UK report shows disparities in bariatric surgery provision continue According to a new report from the UK’s NHS Information Centre, there are still inequalities in bariatric care depending on a patient’s location, rather than need. The report entitled, ’statistics on Obesity, Physical Activity and Diet: England, 2012’, presents a comprehensive picture of obesity in the country by combining new analyses on the health outcomes of people who are overweight or obese with a summary of already published diet, exercise and weight-related information. The findings confirm earlier reports that whether a patient receives bariatric care is ultimately a ‘postcode lottery’. For example, data reveals that East Midlands had the highest rate of weight-loss stomach surgery with 32 procedures for every 100,000 of the population, compared with the North West had the lowest rate of weight-loss stomach surgery with six procedures for every 100,000 of the population, followed by the East of England and South Central with nine procedures for every 100,000. These significant regional variations in hospital admissions shows that patients in the East Midlands are almost six times more likely to gain access to operations compared with those in the North West and twice as likely as those in Yorkshire. In addition, the report also showed that there had been a slight increase in the number of bariatric procedures, although by not the headline figure of 12 per cent some news sources were reporting. The number of hospital procedures for bariatric surgery rose to 8,087 in 2010/11 from 7,214 in 2009/10, a rise of 12 per cent. However, due to changes in procedure coding practices it is now possible to see how many procedures were for the maintenance of an existing band. There were a total of 1,444 such procedures in 2010/11, meaning the actual numbers of procedures was 6,643, although whether this is an increase from 2009/10 is unknown. In Yorkshire, it was noted that the numbers of patients undergoing surgery decreased from 866 in 2009/10 to 837 in 2010/11. “The regional variations in admissions and surgery are very concerning. Having examined the variations, the forum believes that they illustrate a postcode lottery which still exists in England. It is deplorable,” said Tam Fry, from the Na- Tam Fry tional Obesity Forum. “Some primary care trusts abide by National Institute for Health and Clinical Excellence guidance in offering bariatric operation to obese patients but others flout it by making it virtually impossible to qualify for the surgery.” The report also shows that hospital admissions with a primary diagnosis of obesity rose over the past decade from 1,054 to 11,574. In 2010/11, they rose 1,003 from 10,571 in 2009/10. The number of female admissions with a primary diagnosis of obesity (8,654) was almost three times higher than male admissions (2,919) in 2010/11. Of the regions, the North East had the highest rate of admissions with a primary diagnosis of obesity (40 per 100,000 of the population), followed by the East Midlands (36 per 100,000) and London (35 per 100,000). The South West, South Central and North West had the lowest rates of admission with 14 admissions with a primary diagnosis of obesity for every 100,000 of the population. On prescriptions, the report shows that 2010 saw the first recorded decrease in seven years in the number of prescription items dispensed to treat obesity. In the year 1.1 million items were dispensed, a 24 per cent fall on the previous year when 1.4 million items were dispensed. The decrease could reflect the withdrawal from use of two of the three drugs reported on which had been used to treat obesity (sibutramine in 2010 and rimonabant in 2009). “The report charts the growing impact of obesity on both people’s health and NHS resources. It also examines changes in physical activity and diet,” said Chief Executive of the NHS Information Centre Tim Straughan. “Those working in this field may want to examine closely the findings of the report, including the significant regional variations that appear to exist in both the admissions for obesity and those for weight-loss stomach surgery.” In November 2011, UK Health Secretary Andrew Lansley announced a “national ambition” to bring down obesity levels by 2020, although he ruled out regulating against the food industry (see page 10) and urged people to take responsibility for their own health. A Department of Health spokesman said: “We want people to live healthier lives so they do not need to resort to surgery. We are working with charities, local government and industry to make it easier for people to make better choices. However, campaigners seeking greater action and increased resources claim the Government campaign to tackle obesity is woefully inadequate and amounts to little more than telling people to eat less. BARIATRIC NEWS 9 ISSUE 11 | March 2012 Coffee time with Antonio Torres Bariatric News talks to Professor Antonio Torres, current president of the International Federation for the Surgery of Obesity and Metabolic Disorders. Why did you decide to get into medicine? I was born in Malaga, in a little city close to the sea in the south of Spain, and we were looking for work to do in something special. There was no history in my family of medicine. I was dealing with this situation in terms of treating people, helping people. So you always knew you wanted to be a surgeon? Yes. When I was at medical school, to decide to become a surgeon, I was attracted by a very nice professor, Professor A. Suarez . At the time, I was primarily thinking of becoming a pharmacologist. Afterwards I decided to become a surgeon, after this professor convinced me. Why a bariatric surgeon? It was a long history! I only decided this in 1990. We were asked by a very good friend of mine, the chief of the *Endocrinology** Department – he had some problems with superobese patients. We began to operate on those patients in an open way – no laparoscopy. From then until now, things have been going on. We began doing the Scopinaro´s procedure – this is a different procedure, a very aggressive procedure for super obese patients. Finally, around the 1990s, laparoscopic surgery began in terms of doing lap-cholecystectomy and so on, and so we go through this approach of laparoscopic bariatric surgery. Who would you say has been your greatest influence on your career? Many people, I think. In Spain, there are many surgeons – Professor Suarez, my chief of surgery, influenced me. But overall, American professors there influenced me, because I was doing a fellowship, spending a year and a half in different universities all over the States, learning laparoscopic surgery. So there were many professors there, teaching me laparoscopic bariatric surgery. There were many people! Can you tell us about one of your most memorable experiences in your career? There are three of them. First, when I got my PhD, it was a very memorable day for me, because it was the end of a very large, difficult way of becoming a philosophical doctor. The second was when I became a professor of surgery – the day was the 29th of February 2000. When I was nominated as president of IFSO, in Hamburg, last September, it was memorable. Can you tell us a bit about your work as president of IFSO? It’s very complicated to explain – you have to be in contact with many surgeons in many institutions. Our federation has four chapters – the North American chapter, including USA and Canada, the Latin American chapter, European chapter, and the Asian Pacific chapter. I have to be in contact with every chapter, and every month we have a conference call, trying to deal with all our objectives and our issues. This is a lot of work, answering many, many emails and having many commitments, and the most important thing, I think, is trying to bring forth the role of the surgery in dealing with treating patients with obesity. I used to have a lot of commitments in terms of attending meetings in different countries. It’s tough work, but very nice! What’s the most important thing you’ve done as president of IFSO? I got the presidency in September, and I’m very proud of solving a very important problem we had with our journal, Obesity Surgery. We had a very important disagreement in terms of our next step in this sense, and I think to solve this problem is going to be a very tough issue, and I’m very proud of having to get a resolution. How do you think bariatric surgery is going to develop over the next 10-15 years? bariatric surgery. The main reason is because we have to offer the society a very safe surgery, and a surgery with as low a complication rate as we can with no morbidity – no mortality at all with our patients. I think it’s going to be very important to prepare as many units as we can, but at a very highquality level. Away from surgery, when you’re not working, how do you like to relax? I am very lucky because I have very good friends. Of course, my wife and my family are essential for my work I’m sure that it’s going to be a very, very and for my life; my wife is always important increase in bariatric surgery there for support. We enjoy every procedures all over the world, because minute we have free together with my now we have a lot of information about three kids. I have two sons and one how to manipulate the GI tract in a daughter. But nevertheless we are very low-invasive way, laparoscopically. also lucky, because we have three Manipulating the GI tract has a lot of couples we are very good friends beneficial influence in improving obesity with – eight people in total – we move and improving metabolic disorders during weekends and so on almost associated with it, like diabetes, all together, having dinner and so on. hypertension, hypercholesterolemia, Friends and family, I’d say, is the best and other metabolic problems that are way. Of course, I like jogging, I like associated with obesity. sports, I used to run every day and my free time is dedicated to that kind of What do you think the most thing. I’d say in summary: family first, important lesson is that you friends second, and sports third! can teach young bariatric surgeons? It’s very important to train people – it’s essential for the future development of 10 BARIATRIC NEWS ISSUE 11 | March 2012 The 3rd Annual Scientific Meeting of the British Obesity and Metabolic Surgical Society The 3rd Annual Meeting of the British Obesity and Metabolic Surgical Society (BOMSS) was held at the Royal Marriott Hotel, Bristol, UK, 19-20th January 2012. The meeting was attended by 350+ delegates with a specific interest in bariatric surgery. Topics discussed included, commissioning, training, clinical trials, obesity economics and international perspectives. As well as a multi-disciplinary UK-based faculty, the meeting also welcomes international speakers including the president of IFSO, Professor Antonio Torres (see page 9), and president-elect of the OSSANZ, Professor Wendy Brown. As well as lectures and keynote addresses, there was also an array of high quality abstracts and poster presented. The organisers expressed their gratitude to the exhibitors for supporting the meeting. Obesity expert slams government and food industry Professor Philip James, President of the International Association for the Study of Obesity, has delivered a scathing judgement on the UK government’s response to the obesity epidemic. James laid out what he saw as the British government’s public health policy failings, concentrating on British Health Secretary Andrew Lansley’s relationship with the food industry and a governmental belief that obesity is a matter of personal, rather than societal, responsibility. However, the UK risked “losing out” unless the government adjusted its attitude towards battling obesity. “I think that we’re in danger of something bad”, he said. The new group replaces the old Obesity Advisory Group, which Lansley disbanded in November 2011. At the time, Oxford epidemiologist Klim McPherson, who was a member of the group, told the Guardian “too many of us were giving critical voice to the responsibility deal and its effectiveness. They ignored us, then rather than ignoring us, they disbanded us.” “Businesses can make an enormous contribution,” said James. “They are said to be the cause; they could be part of the solution. The question is whether they should be involved in the actual policy.” Responsibility deal Lansley, James said, has violated the World Health Organisation’s principle that conflicts of interest Food Standards Agency should play no role in policy making, by involv- James also expressed concern for Lansley reducing ing senior industry figures in his UK Responsibility the powers of the Food Standards Agency (FSA), which was created based on James’ guidelines to reDeal advisory group. Lansley created the Responsibility Deal as an move food safety from direct political oversight. The FSA developed the “traffic light” food lainitiative to involve the food and drink industry in reducing obesity through voluntary pledges to cre- belling system, which James described as “the most dramatic, brilliant system – in all evaluations it ate healthier products. Representatives from companies such as Uni- comes out best”. Under Lansley, however, responlever, Tesco, Mars, and Diego, as well as interest sibility for nutrition, including food nutrition labelgroups like the Wine and Spirits Federation, the ling, was moved to the Department for Health, placBritish Retail Consortium, the Food and Drink Fed- ing it back under direct ministerial control. eration, and the Advertising Association, says James, are “organising policy” to deal with obesity through their presence on the advisory group. Their presence outnumbers representatives from public health groups, including the Faculty of Public Health, Cancer Research UK, Which, the National Heart Forum, nad the Local Government Association. Professor Philip James, The promotion of indusPresident of the International Association for the Study of Obesity try to advisory roles, he said, Philip James ty drugs] Rimonabant and Sibrutamine have been withdrawn.” “For decades, doctors and epidemiologists have actually been assigning no significance to obesity. If you take blood pressure and cholesterol into account then what does obesity do that is extra and special to cardiovascular disease?” GPs, James said, feel “completely inadequate” in facing the epidemic, believing themselves unable to cope. James saw these factors as directly affecting government policy. “You’ve got to remember that when you talk to politicians, they think like ordinary citizens. And so they think that, as the PM said before the getting election, it’s personal responsibility.” “Can we start making progress and obesity rates down? Yes. We might be able to shame the UK into doing things. Doctors, by getting organised and being coherent, can [have an effect], not just for the benefit of the few, but the many.” minimised the chance of the government adopting initiatives like taxes on fatty foods and tighter regulations on advertising, which could have a dramatic effect on levels of obesity in the UK, but would be likely to harm the profits of food companies. “British Retail Consortium have, on a personal basis, attacked every proposal we’ve produced for 20 years,” said James. “Tesco is the only company that refused to meet me as I tried to compose the Food Standards Agency. Wine and Spirits Federation are a splendid pro-health organisation. Food and Drink Federation lambasted me for four hours with 14 chief executives when I said 10 years ago we should look at whether marketing has any effect on children’s behaviour. I had a ding-dong battle with the Advertising Association in a cabinet minister’s discussion as to what should happen during the last government.” NHS shakeup James had gloomy forecasts for controversial proposed changes to the organisation of the NHS. “What I’m predicting is chaos in the Health Service with battles, reorganisation,” he said. “If you need coherent thinking, it’s not going to come in my view for quite a long time.” The changes were announced in a white paper, “Equity and Excellence: Liberating the NHS”, released in July 2010. In that document, noted James, obesity was not mentioned once. “It’s not on the agenda,” said James, “because it’s an extraordinarily difficult societal question. In the economic crisis, they think it’s more important to back industry, and say to you: stay thin.“ “The World Health Organisation have said unofficially that this is the biggest setback to public health,” said James, “because [the FSA] was a clarion call for governments throughout the world.” “We’ve been talking to the Government for about 20 years about the fact that public health should not be in the Department of Health,” he said. “It should Coordinated initiatives can battle obesity be in the Cabinet Office, looking at all aspects of epidemic In a second Keynote presentation, James claimed government.” that rising obesity levels could be stemmed through Failure of practitioners coordinated programmes and effective use of new James also directed fire at what he saw as the med- data. He said that nationwide programmes in Euroical profession’s failure to come to grips with the pean countries had already worked to reverse rates epidemic. “We as doctors have never put it on the of obesity and diabetes. A combinatory approach map,” he said. “It’s also become a problem be- including regulation, taxation, and intervention in cause in medical terms, people are defeatist, apart groups recognised as high-risk could have a real effrom [when it comes to] bariatric surgery. [Obesi- fect on rates of obesity. Contradictory evidence Obesity rates have doubled or even tripled in many countries since 1980. However, said James, some evidence suggests that rates are beginning to stabilise. In 2008, the Centre for Disease Control in the USA said that the epidemic in American had stopped; between 2000 and 2008, there was a slight median increase in male obesity, and no increase in women (Flegal KM et al, JAMA 2010;303: 235-241). Despite this, said James, diabetes rates are expected to continue to rise. One study (Brown et al, February 2010: National Heart Forum) has projected that more than 6.6% of the UK population will have diabetes by 2046. “There isn’t a country in the world that is going to be able to treat diabetes longterm,” said James. James also voiced his fears of an “intergenerational amplification” in obesity rates. One study (Gale et al, J Clin Endocrinol Metab 2008;92:30943911) found a positive correlation between a mother’s pre-pregnancy BMI and her child’s resultant fat mass index (FMI). The effect was particularly pronounced in girls: the average FMI for girls with mothers with BMI between 20.3 and 21.9 was 1.8; this rose to 2.4 when the mothers’ BMI rose above 24.3 (p < 0.001). This could lead to an effect whereby current levels of obesity could feed into increased levels of obesity in the next generation. European initiatives James did, however, offer hopeful evidence that these trends could be reversed. Effective intitiatives, he said, worked through raising the price of fatty food, limiting its marketing, or limiting its availability. Countries in Europe have begun to introduce initiatives along these lines. Denmark, Austria and Switzerland have banned trans fats, while Finland and Hungary have introduced taxes on foods with high fats, salts and sugars. In France, the government has taken total control of food and drink in schools, banned marketing to children, and restricted marketing of foods high in fat, sugar and salt unless it is taxed and marketed with a health warning. In 2000, 18.1% of children were overweight and 3.8% were obese. By 2007, this had dropped to 15.5% and 2.8% respectively. Finland’s FINRISK system identifies groups who are at risk of developing diabetes by observing factors including weight and family history, and engages them in detailed intervention, encouraging them to live a heathier lifestyle. Over a period of five years, says James, they have managed to shift the distribution of obesity in Finland. James was less optimistic about the UK government’s attempts to tackle obesity, which are mostly pinned on a voluntary “Responsibility Deal” with food manufacturers to encourage them create healthier products and inform customers on the risk. “Most of the measures that have been taken, a lot of them have been rescinded in the last few months,” he said. However, he encouraged the British bariatric community to engage in a public debate. “Can we start making progress and getting obesity rates down? Yes. We might be able to shame the UK into doing things. Doctors, by getting organised and being coherent, can [have an effect], not just for the benefit of the few, but the many,” he said. The 3rd Annual Scientific Meeting of the British Obesity and Metabolic Surgical Society BARIATRIC NEWS 11 ISSUE 11 | March 2012 BY-BAND trial hopes to impact UK surgery The chief investigator of a three-year trial, which plans to determine whether gastric bypass surgery leads to better quality of life and weight loss than gastric, banding, is hopeful that the study will have an “enormous impact” on bariatric practice. Professor Jane Blazeby, professor of surgery at the University of Bristol, said she hoped that if her study, named “Gastric BYpass or adjustable gastric BANDing surgery to treat morbid obesity” (BYBAND; ISRCTN00786323), confirms its hypothesis when it publishes its results it would inform future NHS commissioning and potentially influence international bariatric practice. The BY-BAND trial, has received more than £2.8m in funding from the National Institute for Health Research Health Technology Assessment Programme and will begin recruitment in April this year, plans to establish two points: firstly, wheth- age BMI (47.5 ± 5.5 vs 45.5 ± 5.4; p = 0.01) between the bypass and band cohorts, meaning that differences in outcome could be attributed to differences between the patient groups instead of the differences in operations. It also allowed patients to cross over between cohorts and did not subsequently undertake an intention to treat analysis, further compromising the trial’s randomisation. “At this point, there’s almost no point doing a long-term analysis,” said Blazeby of the study. While non-randomised studies have produced a wealth of data, she said, the fact that patients were deliberately chosen for different operations means that differences between patients confounds any potential conclusions as to the two operations and their efficacy. The lack of firm evidence as to the superior procedure has led to enormous variation in the type of operations carried out, with the decision often coming down to the surgeon’s preference. “There’s variation in the rates between centres in which the procedures are done,” said Blazeby “It’s not as if all surgeons know which one to select; there’s just this massive variation.” Methodology BY-BAND aims to randomise around 726 patients, into either the LAGB or RYGB cohorts. An initial pilot phase will take place at two hospitals in Taunton and Southampton; once this is complete, the trial will be extended to six further hospitals. The randomisation procedure, which will conceal the patients’ allocation from the investigators, will reduce the opportunity for selection bias. The investigators decided to exclude sleeve gastrectomy from the trial as there is currently insufficient long and medium term data on its use, and because it currently only makes up around 10% of bariatric procedures in the UK. The fact that the surgical technique is still changing due to the procedure’s relative novelty also means that it is not suitable for a long-term comparative study. Jane Blazeby Patients will be selected for BY-BAND if they are: er bypass leads to better quality of life than banding, and secondly, whether it is at least as good as banding for weight loss. If both are met at three years after randomisation, then the investigators will conclude that bypass is the superior operation. “If we can achieve what we hope to achieve – if we can really answer the question as to which operation is the most effective and cost-effective – it’s going to have an enormous impact,” said Blazeby. “It will put obesity surgery right up there on the political agenda.” n Over 18 years of age; n Referred for bariatric surgery according to NICE guidelines; n Willing to receive intensive management in a specialist obesity service; n Fit for anaesthesia and surgery; they are committed to follow-up and able to complete quality of life questionnaires; and n Able to provide written informed consent. “We desperately need to know” The investigators initiated the trial after observing a lack of good comparative evidence on the two procedures. “We desperately need to know which operation is better, because we need more operations that are cheaper,” said Blazeby. “We think that BYBAND will provide those answers.” A systematic literature review carried out by the investigators identified 26 randomised clinical trials comparing different bariatric procedures, only two of which directly compared gastric bypass to banding. They also found methodological issues in those that were carried out, making their randomisation questionable. In one well-known study (Nguyen et al, Ann Surg 2009; 250: 631-641), there were statistically significant differences in both the average age (41.4 ± 11 years vs 45.8 ± 9.8 years; p < 0.01) and aver- Patients will be excluded if: n They have a history of gastric or obesity surgery; n They have a large abdominal ventral hernia; n They have a hiatus hernia more than 5cm; n They are pregnant; n They have Chron’s disease; n They have liver cirrhosis and portal hypertention; n They have systemic lupus erythematosis; n They have a known silicone allergy; or n If their surgeon is unwilling for the patient to be randomised. The two primary outcome measures are quality of life, measured by their EQ-5D health state score at three years, and weight loss, measured by the proportion achieving loss of greater than 50% excess weight at three years. The investigators will also be studying a number of secondary outcomes, including time between 50% EWL and first relapse, resource use, nutritional blood tests, binge eating behaviour, adverse health events, and resolution of co-morbidities. Commissioners need data and education Many NHS commis- attempt “all appropriate non-surPrimary Care Trusts [PCTs] sioners are keen to encour- gical methods” first. differ in their rates of bariatric age more bariatric surgery, but they “need help” from medical societies to commission the right operations for the right patients, according to one commissioning manager. Mike Lander, Senior Commissioning Manager at the South East Coast Specialised Commissioning Group, said that while bariatric surgery has been proven to be both effective and cost-effective, commissioners feel they don’t have the data that would allow them to refer patients to optimal procedures and maximise value for money. Lander gave his talk to explain why only around .3% of eligible patients are referred to bariatric surgery every year. “I think we are serious about bariatric surgery,” said Lander. “We just don’t show it very well, and we need to learn how we can show it in a better way.” Operational choices While acknowledging that higher levels of bariatric surgery would lead to lower long-term costs and a healthier population, Lander highlighted the need for cost-effective operations. “We physically cannot give everyone bariatric surgery,” he said. “So who’s going to benefit the most?” The National Institute for Clinical Excellence (NICE) offer guidelines for bariatric surgery, which Lander referred to as “the best guidance around”. However, he said, many of their guidelines are not specific enough for commissioning, including advice to “What constitutes appropriate non-surgical interventions? I don’t know what the answer is. You have to try everything, but what is everything? Cabbage diet for two years? Is it running the London marathon twice? What constitutes failure to lose weight? It depends who you ask. For a patient anything less than going from BMI 50 to 28 is probably a failure.” The range of surgical options available also presents a problem to commissioners, Lander said. “I was at a conference where three eminent surgeons all said theirs was the best kind of surgery. One said band, one said bypass, and one said sleeve. You’ve now got new things – TOGA, POSE, Endo-Barrier, FOBI-ring. I have no idea what to do. Should I just say, fine, do what you like? Can I just buy the cheapest?” “We can’t differentiate on a cost basis between types of surgery. [Gastric banding] is in the short term substantially cheaper than [bypass], but in the long term, are the outcomes the same for both? We need to continue to work on that.” Differing support Commissioners vary in their support of bariatric surgery. “Up until four years ago, I’d never heard of bariatric surgery,” said Lander. “Up until three years ago, I fundamentally disagreed with bariatric surgery as an intervention – like most of the population, I thought obesity was the patient’s own fault. I’m not fat, why should you be?” surgery commissioning. Each decides its own priorities for healthcare spending, and while many follow guidelines supplied by the National Institute for Clinical Excellence, they are not mandated to do so. Lander noted that there is no correlation between the rate of obesity within a PCT’s area and the number of operations that the PCT commissions. Bariatric Surgery is currently defined as a NHS Specialised Service. Commissioning of the service is not consistently carried out by the by the regional Specialised Commissioning Groups [SCGs], however, remaining instead within the PCT’s budget. PCTs and SCGs will cease to exist from April 2013, being replaced the NHS Commissioning Board, and local Clinical Commissioning Groups. It has not yet been announced who will be commissioning bariatric surgery. Lander’s PCT area has a slightly higher rate of surgery than the UK average, at .8%. However, he said, this was also limited by another factor: the patients themselves. “It’s not because we’ve done anything to stop them coming in,” he said. “We’ve followed the NICE guidance; they’re self-presenting.” The solution, says Lander, is to gather more knowledge, and to better share the knowledge that already exists. “We have to educate the commissioners,” said Lander. “We have to educate society. We have to educate them that obesity’s a problem, and that one of the solutions is bariatric surgery.” 12 BARIATRIC NEWS ISSUE 11 | March 2012 XVI World Congress of 3rd the International Federation for the of Obesity andand Metabolic Disorders The Annual Scientific Meeting of Surgery the British Obesity Metabolic Surgical Society Vitamin deficiencies “easily avoided” Vitamin deficiencies in bariatric patients could be easily prevented with more research and greater use of existing knowledge, according to a nutritional expert. Nutrition expert Erlend Aasheim of the Department of Public Health and Primary Care, University of Cambridge, said that symptoms of vitamin deficiencies were often evident in bariatric patients, but should be easily avoided with careful observation and the use of dietary supplements. The absorption of nutrients in bariatric patients is complex, said Aasheim. An operation may bypass the primary absorption point for a mineral in the GI tract, or factors can interact, and a deficiency in one nutrient can lead to deficiency in another. Existing studies into malabsorption are methodologically problematic, for a number of reasons, said Aasheim. Populations with different characteristics and diets have been used, surgical methods vary, supplementation regimens and levels of adherence weren’t reported, and there is no standard protocol for changing the supplement regimen on review of blood tests. Results have accordingly differed substantially. “It’s extremely difficult to make sense of these studies, in my opinion,” said Aasheim. However, one study which Aasheim described as “one of the best” (Gasteyger et al, Am J Clin Nutr 2008; 87: 1128-33) did provide evidence that a multivitamin is not sufficient for most patients to avoid malnutrition. The study gave 137 gastric bypass patients a single multivitamin each and monitored their nutrient levels at six-month intervals. Patients with low vitamin levels were given top-up supplements. After two years, nearly all of the patients in the study were using supplements. By the end of the study, 80% of patients were deficient in vitamin B12, 60% were de- Erlend Aasheim ficient in iron, 60% in calcium and vitamin D, and 45% in folic acid. Following this study, Aasheim recommended vitamin B12 as a baseline supplement, as most patients are going to become deficient without it. Compensating In many cases, said Aasheim, supplementation and other effects can actually lead to increased nutrient levels in bariatric patients. This can be beneficial, as obese patients often have low vitamin levels before surgery. In a study (Aasheim et al, Am J Clin Nutr 2008; 87: 362-9) looking at 110 obese patients before surgery, he found that 10-40% had deficient levels of vitamins B6, C, D, and E. A recently published study (Aasheim et al, Surg Surgeons need to look at patients’ psychological factors The psychological condi- from psychology that recall of information of a bariatric patient can be an im- tion is context-specific,” he said. “One portant indicator of the success of his treatment, according to a psychiatric specialist. Dr Tom Stevens, consultant general adult and liaison psychiatrist at South London and Maudsley NHS Trust, said that psychiatric professionals can help establish whether a patient is psychologically able to cope with the demands of bariatric surgery. Stevens was presenting with Dr Lisa McClelland, consultant general adult psychiatrist at Devon Partnership NHS Trust. Bingeing and bulimia Stevens identified two main eating disorders that are associated with obesity: binge eating, and bulimia nervosa. Binge eating is defined under the DSM4 as eating, within a discrete period of time, an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances, coupled with a sense of lack of control over eating during the episode. These episodes should occur, on average, at least twice a week for three months. Bulimia nervosa has similar symptoms to binge eating disorder, with added inappropriate compensatory behaviour to prevent weight gain, like self-induced vomiting or laxatives. Diagnosing binge eating, said Stevens, is difficult to define due to the clinician having to rely on the patient’s unreliable recall of their food intake. “We know of the problems is that people are in the calm context of the clinic when they are getting access to their history of eating, which is undertaken in an emotive state.” Adverse outcomes and risk Stevens said that bariatric surgery can lead to adverse psychiatric outcomes. Patients who don’t disclose their problems with bulimia before surgery can amplify their self-induced vomiting. Enduring binge eating, malnutrition, and resultant psychiatric relapses can all result from unrealistic expectations of surgery. Also, while overall most instruments that measure mood show an improvement over the first 18 months of surgery, there is still an increased risk of suicide within the group. These outcomes are controversial, however, as the evidence supporting them is largely based on case reports, rather than studies. Despite the severity of the risks, there is no consensus about the exclusion criteria for patients with mental issues. The American National Institutes of Health suggest that uncontrolled psychopathology is an exclusion criterion, while NICE does not offer any guidance. In response, Stevens and McClelland, along with Samantha Scholtz, created a traffic-light system of psychological indications for bariatric surgery (see boxout). Patients with green indications are generally psychologically able to undergo bariatric surgery. Those with amber in- Obes Relat Dis 2011, epub 5 Feb) showed a significant increase in levels of vitamins B6, folate, B12, A, and E adjusted for lipids, compared to increases in vitamin levels provided by lifestyle changes alone. Wernicke’s Encephalopathy Aasheim also encouraged doctors to be particularly careful to watch for Wernicke’s Encephalopathy [WE], which is caused by vitamin B1 (thiamine) deficiency. WE has symptoms including an unsteady gait, disturbed eye movements, and confusion and changes in behaviour. While treatment can reverse the symptoms, the condition is only completely reversible if treated quickly. In a literature review that Aasheim carried out (Aasheim, Ann Surg 2008; 248: 714-20), he found that around one in 500 patients who undergo biliopancreatic diversion subsequently develop WE. “It’s potentially lower after gastric bypass, but we don’t know that,” he said. Aasheim hypothesised that WE could be brought on in patients who suffer from frequent vomiting, saying that it occurred in 90% of the cases in his study, and generally lasted for around three weeks. “The body can become deficient in thiamine in 1820 days. It fits very well with the duration of vomiting,” said Aasheim. In about 20% of cases, the patient had received intravenous glucose, which can also trigger thiamine deficiency. Other symptoms that indicate WE include eye movement signs (70% of cases), mental status changes (64%), leg neuropathy (60%), and gait ataxia (57%). Aasheim described investigating to confirm a suspected diagnosis as “a double-edged sword”, as delaying treatment can harm the patient. “In about 50% of cases in the review had some form of lasting permanent neurological damage,” said Aasheim. “These people can end up in wheelchairs and in the nursing home. Two or three of them died, so it’s extremely severe.” dications are usually able to make an informed choice, but are at risk. “It’s contingent on everybody to optimise their functioning before they have their operation,” said Stevens. Red indications, which Stevens described as “probably the most controversial”, mean that “in our opinion you shouldn’t be proceeding with surgery and the patient will probably need to be sent back to a mental health service before you proceed.” Overcoming issues Stevens said that there were some that psychologists and psychiatrists were working to overcome in the bariatric service. Despite being able to make recommendations based on a patient’s psychosocial history, psychiatrists cannot predict weight loss. “There’s a real question mark regarding our role, considering we’re not able to predict outcomes,” said Stevens. Stevens also highlighted the risk that psychiatrists may block access to treatment and inadvertently discriminate against patients with mental health problems. The lack of an evidence base to rely on also presented issues for psychiatrists. “So there’s this discourse,” said Stevens, “suggesting that if people turn up to all their appointments, that’s a sign they’re motivated enough – go ahead with surgery, as long as they meet the NICE criteria.” NICE guidelines, said Stevens, are vague on the use of psychiatry and psychology in the treatment of obesity. However, mental health professionals can help to identify patients who, while fitting into the NICE criteria, are mentally unsuitable for surgery. Psychological indications traffic light system Green n Appropriate motivation – health rather than mental health nGood understanding of procedure and outcomes n Appropriate expectations for weight loss etc nRegular balanced diet nInsight into eating and causes of weight gain. n Proven compliance Amber nIn cases of severe mental illness, mental state should be stable with no hospital admissions or act of deliberate self harm for previous 12 months n History of alcohol or substance misuse n History of eating disorder n Mild learning difficulties n Poor motivation n Unrealistic expectations n Binge eating disorder nInadequate insight into eating behaviours n History of poor compliance Red n Unstable psychosis n Active substance misuse and alcohol dependence n Severe/moderate learning difficulties nDementia n Severe personality disorder n Self-harm within last 12 months n Active bulimia nervosa nCurrent non-compliance with treatment King Henry VIII’s gastric band Would you give the British Tudor King Henry VIII bariatric surgery? The answer to that question, says Dr Tom Stevens, speaks volumes about the importance of psychiatric observation in bariatric treatment. Using measurements from Henry’s suits of armour held in the Royal Armoury, it is possible to estimate his BMI; by the age of 50, he was massively obese, with a BMI of around 51. He also had several comorbidities, including diabetes, immobility, and leg ulcers. If surgeons operated using NICE guidelines in the Tudor period, they would never have found a more suitable candidate for surgery. But, says Stevens, would you want to operate on him? Would you want to risk a band slippage? Henry had a worrying tendency of killing people who disappointed him. His eating habits were also less than healthy: he ate up to 13 meals, and drank around 13 pints of beer, every day. He was described as “paranoid, aggressive and intelligent”, and had a history of head injury. Put like that, he suddenly seems like less of an ideal patient. “We might suggest neurosyphillis, we might suggest hypothalamic obesity as a result of the head injury,” says Stevens. “It would probably be a very brave psychiatrist who would suggest he had a personality disorder.” Taking a good psychosocial and weight history of a patient, says Stevens, can give you a strong idea about whether a patient is going to be able to cope with surgery. Between the ages of 40 and 50, Henry’s weight grew rapidly. During that time, he went through five wives, two of which he beheaded; he was dealing with wars in Europe, and separating the Church of England from the Catholic Church in Rome. Given the situation, says Stevens, “you have to consider whether he would be able to control his eating after bariatric surgery”. XVI World Congress of 3rd the International Federation for the of Obesity andand Metabolic Disorders The Annual Scientific Meeting of Surgery the British Obesity Metabolic Surgical Society 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 14 BARIATRIC NEWS ISSUE 11 | March 2012 A snapshot of India In this issue, our ‘Snapshot’ Mumbai features Mumbai in India, and a recent report examined the prevalence of metabolic syndrome in the city. In India, epidemiologists and international agencies have been sounding an alarm on the rapidly rising burden of cardiovascular disease (CVD) for the past 15 years. It is estimated that by 2020, CVD will be the largest cause of disability and death in India, with 2.6 million Indians predicted to die due to CVD. M etabolic syndrome (MS) is a complex web of metabolic factors that are associated with a two-fold risk of CVD and a five-fold risk of diabetes. Individuals with MS have a 30%–40% probability of developing diabetes and/or CVD within 20 years, depending on the number of components present. MS consists of an atherogenic dyslipidemia (ie elevated triglycerides and apolipoprotein B (apo-B) and low high-density lipoprotein cholesterol (HDL-C)), elevation of blood pressure and glucose, pro-thrombotic and pro-inflammatory states. The aim of the report was to assess the prevalence of MS as defined by NCEP ATP III guidelines with a modification to the value for BMI that is more applicable to the Asian Indian population, and to look for the differences between the various components constituting MS. Along with the prevalence of MS, the investigators from Research Laboratories, PD Hinduja National Hospital & Medical Research Centre, Mumbai, also studied the prevalence of various risk factors leading to atherosclerotic CVD. A total of 560 subjects, who attended the free CARDIAC evaluation camp arranged by PD Hinduja National Hospital and Medical Research Centre by general advertising, were recruited in the study. Among the 560 subjects, 548 (302 males and 246 females) who had all the required data for the analysis formed the study group. Each participant was interviewed by a group of research students and completed a standardized questionnaire containing information on demographics, anthropometric profile, individual characteristics associated with the major risk factors of CVD, past medical history, and biochemical parameters (Table 1). Prevalence of diabetes and hypertension was ascertained based on self-report of the physician’s diagnosis and/or use of prescription medications along with medical records of therapeutics. Blood samples were collected and analysis was performed via an automated clinical chemistry anal- yser. The prevalence of MS was calculated using the prevalence rate formula: number of patients per total number of all subjects at the time of study multiplied by 100. A total of five hundred and forty eight subjects participated in the study. On applying modified NCEP ATP III, consensus guidelines for defining obesity in Asian Indians and ADA, we found out that nearly 95% of the subjects had at least one abnormal parameter. The general characteristics of the study population are given in (Table 3). Demographic characteristics The gender distribution was 56.75% males and 46.71% females and the age of the subjects ranged from 20 to 90 years, with a mean age in males of 54.28 years and in females of 52.67 years. Of these, 18.65% males and 16.02% females were in 20–40 age group, 47.91% males and 57.42% females were in 41–60 age group, and 33.44% males and 26.56% females were >60 years old. Results The results showed a mean BMI of 25.68 in males and 26.95 in females, which clearly shows that the prevalence of BMI ≥23 kg/m2 was significant in females than in males (p=0.008). Both in males and females, the prevalence of overweight BMI (≥23 kg/m2) shows linear increase with age and was found to be more in males than females. The overall prevalence of BMI (≥23 kg/m2) was 79.01%. The prevalence of obesity was high in 41–60 age group females than 20–40 age group and >60 age group. The prevalence of obesity is almost the same in 20–40 and 41–60 age group males but drops down as age advances. The incidence of abdominal obesity observed was 70.9% and waist to hip ratio was 73.76%. It was found in the current study that history of hypertension and diabetes increases as age advances both in males and females. Prevalence of history of diabetes was significant in males than in females (p=0.015). Prevalence of history of hypertension in both males and females was highly significant in 41– BARIATRIC NEWS 15 ISSUE 11 | March 2012 Prevalence (%) 80 60 40 20 0 20–40 years 41–60years >60 years Total 20–40 years 41–60years Men Total Women Hypertriglyceridemia Hyperglycemia >60 years LOW HDL-C Abdominal obesity 80 Females Prevalence (%) Males 60 40 20 60 age groups (p=0.001). History of diabetes in 41– 60 age group males was highly significant (p=0.001). Prevalence of family history of cardiovascular diseases was observed in 27.76% subjects. Increased fasting blood glucose, hypertriglyceridemia and decreased levels of HDL-C were found to be more in males with high TG and low HDL-C to be highly significant (p=0.001). Hypercholesterolemia was highly significant in females as compared to males. Both males and females in 41–60 age groups showed significantly high levels of impaired glucose levels (p=0.001). On further comparing age wise, prevalence of low HDLC in 20–40 age group males was 64.91% which is very high as compared to other age groups both in males and females. In males, the prevalence of hypercholesterolemia, and hypertriglyceridemia was found to be more in 41–60 age group. In females, fasting blood glucose, hypertriglyceridemia and hypercholesterolemia showed a linear increase with age. The overall prevalence of MS having ≥3 components was 19.52% by modified NCEP ATP III criteria. The prevalence of MS in males was almost double (25.16%) than females (12.6%), and this was highly significant (p=0.008). For age, the distribution of prevalence of MS was found to be the same in 20– 40 and 41–60 age groups (20.61% and 20.76%), respectively, whereas >60 age group showed a marginal decrease in the prevalence (16.66%). The prevalence of individual components of MS is reported in Figure 1. The prevalence of major risk factors of atherosclerotic CVD was 45.25% overweight, 33.75% obese, 39.96% having impaired blood glucose levels, 39.96% subjects with hypercholesterolemia, 38.13% with hypertriglyceridemia, and 47.97% with low HDL-C. The prevalence of elevated cardiac markers was 2.18% with high APO B, 1.82% with increased APO A, 30.65% and 8.39% with elevated levels of Lp(a) and hsCRP, respectively. The genderspecific prevalence of different atherosclerotic risk factors is reported in Figure 2. The development of obesity, or more specifically an increase in abdominal fat, is thought to be the primary event in the progression of MS. A tendency to gain fat in the abdominal area, as opposed to the hip, buttock, and limb areas, is linked to a rise in fatty acids in the blood, which is thought to lead to insulin resistance, high blood pressure, abdominal blood lipids, and eventually diabetes. Asian Indians tend to develop central obesity rather than generalised obesity. About three fourth of the subjects participated in study were overweight/ obese (BMI≥ 23kg/m2), being a prime determinant of MS prevalence. Of these around one third of overweight/obese subjects had impaired glucose tolerance and many exhibit features of MS. Obesity reduces HDL-C levels, and obese patients with MS and atherogenic dyslipidemia almost always have low HDL-C levels. This study shows that around 35% of subjects had low HDL-C were either overweight or obese. High APO-B High APOB/APOA ratio H/O HTN Alcohol Family H/O CVD High Lp(a) High FBS Low HDL-C Abdominal obesity BMI (overweight) High TC High TG BMI (obese) Smoking H/O diabetes High hsCRP Low APO-A 0 Conclusion The prevalence of MS varies amongst ethnic groups. Indians are high at risk for CVD and their predispositions. The prevalence of MS was double in males as compared to females and this study revealed the increased prevalence of MS to be more prevalent in 41–60 years, suggesting that this group is at increased risk of developing CAD. The investigators also reported that the high percentage prevalence of overweight and obesity was one of the major driving forces in the development of MS. Therefore, they concluded that an early identification of the metabolic abnormalities and appropriate intervention may be of primary importance in similar populations. Source: Apurva Sawant, Ranjit Mankeshwar, Swarup Shah, et al “Prevalence of Metabolic Syndrome in Urban India,” Cholesterol, vol. 2011, Article ID 920983, 7 pages, 2011. doi:10.1155/2011/920983 16 BARIATRIC NEWS ISSUE 11 | March 2012 The future of obesity treatment The inaugural ‘London 2012: Future of Obesity Treatment' meeting was held at the Royal College of Physicians, London, UK, on 3 February 2012. This state of the art international symposium was attended by general practitioners, surgeons, physicians, diabetologists, endocrinologists, gastroenterologists, endoscopists, commissioners and managers, all of whom face their own specific challenges in this evolving field. In addition, an international multi-disciplinary faculty assessed the factors required to create a multidisciplinary approach involving and promoting collaboration across different specialities including physicians, surgeons, policy makers, commissioners and managers, to combat obesity. The faculty reviewed the current status of obesity treatment and discussed how best to address the challenges in the future. Mr Gianluca Bonanomi, Chelsea and Westminster Hospital London, welcomed delegates to the meeting by stating that although there is an increasing acceptance of obesity there still remains prejudice, discrimination and a lack of appreciation by the general public that obesity can have an impact of the quality of life as well as lifethreatening consequences. “This is why we must ask questions about the future of obesity treatment, both in terms of prevention and treatment of this condition,” he stated. “A more pertinent question maybe: how do we allocate scarce resources?” Professor Sir George Alberti, University of Newcastle/Imperial College London, UK, made the first presentation entitled, ‘How will the International Diabetes Federation (IDF) statement change the future?’ in which he discussed the guidelines and how and why the IDF came to its conclusions. He began by stating that the guidelines were required because there is a global type 2 diabetes epidemic and it is ‘out of control and getting worse’. For example, in China alone there are an estimated 91 million people with diabetes. He stated that efforts to prevent obesity had failed, partly because the food industry has a major influence on governmental policy. The statement was written by 20 leading experts in diabetes and bariatric surgery who have made a series of recommendations on the use of weight-loss surgery as a cost-effective treatment option for severely obese people with type 2 diabetes. “The reason we issued on a statement was to give access to patients who without surgery would be causing a detrimental effect to their health, possibly reducing their lifespan by 20-30 years,” said Alberti. According to the statement there is increasing evidence that the health of obese people with type 2 diabetes, including their glucose control and oth- er obesity-related comorbidities (conditions), can benefit substantially from bariatric surgery under certain circumstances. The IDF's Taskforce on Epidemiology and Prevention of Diabetes convened the expert group with specific goals to: nDevelop practical recommendations for clinicians on patient selection and management nIdentify barriers to surgical access n Suggest health policies that ensure equitable access to surgery nIdentify priorities for research “So how will the International Diabetes Federation (IDF) statement change the future of obesity treatment? I Gianluca Bonanomi hope they will impact upon people’s view that surgery is a valid option for treating certain patients, specifically in resolving type 2 diabetes,” concluded Alberti. “Metabolic surgery should be complimentary to medical therapy as it is the most effective treatment for patients with a BMI >35 and with a multi-disciplinary team approach including nutritionist, psychologists it can have considerable long term benefits.” The medical approach to obesity Dr David Haslam, Chairman, National Obesity Forum, then outlined the problems of obesity in the general population and how as a General Practitioner, he faces obese patients on a daily basis. In his presentation entitled, ‘Obesity: What is the challenge for the community?’ Haslam said that when trying to communicate with obese patients it is imperative to identify, engage and motivate patients. “The next step is to try and make them understand that obesity is having an effect on their blood pressure, cholesterol and their overall quality of life,” he said. “But no one of this can be achieved unless you engage with them.” He added that there was a problem with engaging the male population, and although the Men’s Health Forum has done tremendous work by going to factories and work places he said that much more was required to communications with men. Centres like the Rotherham Institute of Obesity (RIO) have shown that dedicated, unique and specialist centres with a multidisciplinary approach to reducing and maintaining weight loss can have a successful impact, said Haslam. The centre boasts that “RIO does not claim to have invented the cure for weight problems, and cannot guarantee weight loss for patients, but it brings together all the NHS approved and evidence-based methods for weight loss into one Primary care based Centre in the hope that we can maximise the chances for weight loss.” RIO forms part of the award-winning NHS Rotherham Weight Management Strategy that won the 2009 NHS Health and Social Care Award for best commissioned service. “The role of the primary care GP is badly understood, so my plea to surgeons is following surgery give the patient as much information as possible about their post-surgery regime (nutritional supple- George Alberti ments etc) and please contact us and advise us on what we should be monitoring and how often,” concluded Haslam. “Most GPs are not aware of the risk of post-surgery morbidly obese patients so please communication the dangers with us.” In his presentation, ‘Which patients stand to gain most from obesity treatment?’ Dr Simon Aylwin, King’s College London, UK, said that this was an almost impossible question to answer but said he would explain some of the questions that should be considered in trying to answer the question. “Historically, prevention consisted of diet, exercise and risk factor management, however for today’s patients who are aged >55 with co-morbidities intervention is required. But what intervention?” asked Aylwin. “There are a whole host of medical therapies available to treat co-morbidities such blood pressure, diabetes, cholesterol, but there are no medical therapies available to treat their obesity.” Even though the Swedish Obese Subjects (SOS) BARIATRIC NEWS 17 ISSUE 11 | March 2012 David Haslam study recently reported that patients who undergo gastric bypass surgery are less likely to have cardiovascular events than people who receive more conventional treatment for their weight condition (Journal of the American Medical Association, Sjostrom et al. JAMA 2012; 307: 56-65), he suggested that it is not the number of heart attacks, but whether the patient survives it. He argued that the evidence is not there yet to categorically state that obesity surgery is useful in preventing death, however it is useful in preventing disease, dysfunction and dissatisfaction. Another aspect of surgical intervention is economic, and Aylwin presented economic models that showed that if 25% of patients had surgery they would incur less overall costs than patients who continue with medical therapy only, saving approximately £1billion. He concluded by asking who is appropriate for bariatric surgery: “I know who is eligible but who requires it the most, what about those with psycho- Simon Aylwin socio dysfunctionality? Such conditions are the harbingers of medical disease and should be considered as reasons for intervention.” In the next presentation, Professor John Wilding, University of Liverpool, UK outlined the current status of obesity and diabetes treatment. “In the diabetic patient the important consideration is the prevention or delay in the development of diabetes related diseases and/or conditions,” said Wilding. “However, one of the most important concerns of a diabetic patient is weight gain as most of the drugs have the consequence of making them fatter.” The overall aim of treatment is to reduce the burden of diabetes and improve the patient quality of life, whilst reducing the costs. He cited evidence that suggests with early intervention and reducing glucose levels down to almost normal levels the burden of diabetes related complications can be reduced, but not completely resolved. However, he warned that there was evidence to suggest that if this treatment was performed later and with the wrong agents it may actually cause additional damage. “If lipid lowering and blood pressure lowering treatment is added to glycaemic control then this can have a profound effect on cardiovascular outcomes,” added Wilding. “The take home message is that early intervention works and is most effective for all the risk factors.” The evidence shows that the more obese the patient becomes their lipid control and blood pressure worsens. In Wilding’s institution in Liverpool, they demonstrated that if a patient is a diabetic with a BMI >35, their coronary artery disease risk is the equivalent to someone ten years older due to increased risk factors. However, studies show that patients who lose modest amounts of weight (eg two stones/28lbs) are associated with the highest amounts of reduced mortality. cus on the need to reduce weight and improve the quality of life. The Look ahead study that is examining lifestyle management has reported weight loss and lipid reduction, although it does not indicate success- John Wilding ing that the National Health Service (NHS) is currently under great economic strain and its resources are increasingly stretched. He stated that the cost of bariatric surgery is determined by tariff on the NHS and on average a band will cost approximately £2,500 and a bypass up to £8,000 (not total costs but what the commissioners pay). “Bariatric surgery has lots of evidence that it is cost effective, our own analysis shows that over a ten year period the total cost of treating a patient who is eligible for bariatric surgery (including surgical and post-operative care) is £20,000. By comparison the cost treating a patient who is eligible for bariatric surgery with primary care is approximately £40,000. We need to be very clear about which is the right surgical treatment and what is the right price.” It is not sufficient just to look at surgical cost but to look at the entire patient pathway, follow-up regime, complication rates, re-admissions etc, he added. However, despite the obvious financial advantages, Lander stated that the problem is that the “Most GPs are not aware of the risk of post-surgery morbidly obese patients so please communicate the dangers with us.” Trade-off According to Wilding, there is a trade-off between the side effects of therapy and a patient’s quality of life. The evidence shows that if you gain weight and have lots of hypoglycaemia your quality of life gets worse, whereas if you lose weight and reduce your hypoglycaemia, your quality of life improves. Therefore, he argued, there should be a greater fo- David Haslam ful weight loss long term. Such studies demonstrate that lifestyle management does have a place. Wilding then examined drug use for weight loss and looked at the Xenical in the Prevention of Diabetes in Obese Subjects (Xendos) study, which showed orlistat therapy reduced the incidence of diabetes beyond the result achieved with lifestyle changes only, an effect that was especially evident in patients with baseline impairment of glucose tolerance. “Diabetes results in significant morbidity and mortality, and we need to manage all the risk factors not just glucose”, concluded Wilding. “Obese patients do less well so we need to combat the obese population.” Economic analysis Adding an economic aspect to the discussions, Mr Mike Lander, Commissioner South East Coast England, asked ‘How can health care systems afford obesity and diabetes treatment?’ He began by stat- Continued on page 18 Steve Bloom 18 BARIATRIC NEWS ISSUE 11 | March 2012 The future of obesity treatment Contniued from page 17 evidence does not identify those patients who will benefit the most. Moreover, he also stressed that there is a difficulty in understanding and interpreting definitions and endpoint such as ‘clinically significant weight loss’ and ‘failure’, as the perceptions of the clinician and patient vary greatly. In concluding, he called for greater cooperation between professional medical societies and associations in developing a consensus of opinion and asked the audience to remember that ‘more care is not always the right care’. Novel therapeutic approaches to obesity Professor Sir Steve Bloom, Imperial College London, UK, started his presentation entitled, ‘Is the magic medicine on the horizon?’, by stating that as far as obesity is concerned the pharmaceutical industry has not done very well. He explained that despite several promising agents, weight loss has not been sufficient and/or the agents have had severe side effects. For example, he cited the NPY neurotransmitter and the consequences of what happened when researchers attempted to ‘block’ it as it is a significant activator of appetite. It was successful so far as the animal’s appetite was suppressed and weight loss was achieved. “The problem is that NPY is responsible for a lot more than appetite, so by using a blocking agent all the other responses the neurotransmitter affects were also blocked,” he added. “Therefore, any attempt must be more targeted.” Gut hormones have been shown to physiologically inhibit appetite as well as inhibiting the hunger hormones ghrelin. Interestingly, the obese subjects in one study had more endogenous PYY suggesting they have a lack of satiety signal and further suggesting that this could be the reason they are obese. “Once you get fat and have a low PYY release, a lack of satiety signal and it will be difficult to lose weight,” said Bloom. “Therefore, by defusing PYY you are actually rectifying this deficiency.” He said that it was also interesting to note that hormones do activate the appetite areas of the central nervous system and a combination of hormones produce a bigger effect than if administered separately. “Therefore, it appears as though appetite is regulated by these circulatory gut hormones,” he commented. Bloom concluded by summarising his latest research using a combination approach which appears to show greater weight loss delivered via a single injection, joking that he hoped this would put surgeons out of work. tion. For example, endoscopic procedures could be utilised to treat a patient’s metabolic disease (diabetes) before they become obese, they could be used to intervene earlier before the patient’s condition tive, long-term treatment available and is proven safe, “safer in fact that gall bladder surgery,” he argued. In his presentation, ‘The future of obesity treatment: how can we influence policy makers?’ Larvin revealed the huge disparities in bariatric surgery provision in the UK, with one Primary Care Trust (PCT) performing a single procedure whilst another performed 192, and one in ten PCTs ignoring National Institute of Clinical Excellence (NICE) guidelines. “This is despite the National Bariatric Surgery Registry (published in March 2011) not only confirming the safety and effectiveness of surgery, but also that surgery resulted in the resolution of co-morbidities and cleared demonstrated that surgery was making a real difference to patient’s lives,” he explained. “A real concern is localism, leaving it to local providers to decide provision with no overall national standards. We would not allow this to happen for cancer, so why would we allow this to happen for obesity?” said Larvin. “This could happen despite the evidence suggesting that over the next 20-30 years obesity-related deaths will reach those of cancer.” Christopher Thompson In conclusion, he surmised that all stakeholders must lobby government to provide an effective long-term strategy to fight obesity because at the moment short-term savings were leading to longdic or cardiac patient’s treatment pathway can in- term costs. clude lifestyle changes, medical therapy, minimallyinvasive intervention (arthroscopy and angioplasty) The good, the bad and the ugly to major intervention (replacement and bypass). Next, Dr Nicolas Christou, McGill University, MonCurrently, Thompson argued that there treal, Canada, examined the outcomes form bariatric surgery in a presentation entitled, ‘What are the was no minimally invasive option. He then explained the step-by-step long term outcomes of bariatric surgery? The good, methodology of endoluminal verti- the bad and the ugly’. He stated that data from the cal gastroplasty using a transoral ap- Canadian National Health and Nutrition Examinaproach to suture the anterior and poste- tion Survey (NHANES) has shown an increase in rior gastric walls. Thompson cited the the average BMI in both men, women and more series by Dr Roberto Fogal who report- alarmingly, children. “And although the data has ed 64 patients achieved EWL 58.1% at not yet confirmed this, I believe obesity has now 12 months. He also mentioned the Tran- surpassed smoking at the leading cause of death in soral Gastric Volume Reduction as an North America,” he added. “There has to be a more Intervention for Weight Management aggressive approach to obesity, lifestyle changes (TRIM) which treated 18 patients us- work but only in the short term. Likewise, surgery ing the RESTORe Suturing System and does work but only when combined with sustained reported modest decreases in weight, follow-up with lifestyle modifications. But which BMI and waist circumference. Howev- surgeries are effective?” In a quick fire summary of the procedures, Chriser, the plications were not durable and the effects of the procedure varied wide- tou outlined the type of procedure (predominantly malabsorptive, predominantly restrictive etc), the ly among the study participants. Thompson also mentioned the en- operative risk associated with each, as well as the dosleeve and the benefits of a new technology, magnets. These can be place endoscopically and can be manipulated to form shapes and could be particularly helpful in suturing. “In conclusion, in order to treat obesity it is necessary to have a multi-disciplinary approach and different treatment paradigms to facilitate intervention at a variety of different stages of the disease,” he concluded. “The long term efficacy, safety and cost effectiveness need to be assessed, but I am hopeful that they will utilised in the fight again obesity.” “Once you get fat and have a low PYY release, a lack of satiety signal and it will be difficult to lose weight. Therefore, by defusing PYY you are actually rectifying this deficiency… Therefore, it appears as though appetite is regulated by these circulatory gut hormones.” Endoscopic therapies The final speaker of the session was the world leading expert on bariatric endoscopy, Dr Christopher Thompson, Harvard Medical School, Boston, US, who asked ‘Can obesity be treated using an endoscope?’ He began his talk by acknowledging that all the current bariatric procedures are effective on an individual patient basis, although they do have limitations including complications, post-surgical nutritional deficiencies, post-surgery regime compliance and cost. In addition, he said that lifestyle changes (diet) and medical therapy did not work in the long term and had so far provide unsuccessful, respectively. “Therefore, we have surgery which tends to be more effective but a higher risk and lifestyle of medical therapy which reduce the risk but are less effective,” commented Thompson. “I think the less invasive endoscopic approaches could provide the solution as a low risk, highly-effective bariatric procedure.” He said that there could be an array of endoscopic treatment modalities to treat patient’s condi- Steve Bloom worsens (ie. BMI<30) or these newer endoscopic procedures could be used at a bridge therapy to assist patients in losing sufficient weight so they can have additional surgery (eg orthopaedic or cardiac surgery). Thompson described several different endoscopic approaches currently on the market or under development including suturing devices, gastric balloons, staplers, plicating devices and implantable sleeves. Each one of there may have a role in certain categories of procedures, for example the suturing device may have a role in bridge therapy or early intervention, he added. He explained that the aim of bridge therapy is to achieve significant weight loss over a relatively short period of time and the durability of the procedure is not of crucial importance as this is a temporary intervention. One such procedure is an intra-gastric balloon (air filled balloons, fluid filled balloon, double balloons), which has been shown to lead to effective weight-loss, with few complications. “For early intervention,” Thompson said, “Safety is paramount and durability and repeatability do become important for these procedures.” He said that obesity is missing a component that is seen when treating other conditions. For example, an orthopae- The surgical approach to obesity Speaking on behalf of the Royal College of Surgeons, Mr Michael Larvin stated that bariatric surgeons are facing decades of operating on morbidly obese patients as surgery is the only effec- Mike Larvin BARIATRIC NEWS 19 ISSUE 11 | March 2012 re-operation and complications rates. “No matter which procedure you choose, the outcomes show weight loss and improvements in co-morbidities, as long as patients abide by their post-operative regime and attend follow-up sessions,” he stated. “What we must be careful of is that patients do follow post-operative regime and attend follow-up sessions so we can assess (among other things) any sign of nutritional deficiencies.” Costs Christou cited a Canadian study that showed bariatric surgery resulted in the reduction of co-morbidities and that within three and a half years, the cost of surgery had been paid for by the savings made in treating the patient’s co-morbidities. Many of the patients are expected to live for 15, 20 maybe 30 years, so the actual saving over a long period of time is very substantial, he added. According to Christou, the perception of surgery needs to change as at the moment the public and the has a modest impact on type 2 diabetes. “There are challenges of creating and running these trials, particularly costs,” he stated. “And there are also challenges of recruiting patients to an arm that we know is not effective (medical therapy).” The case for the safety and efficacy of bariatric surgery is already proven, said Schauer, with hundreds of thousands of cases over 20 years demonstrating a very low mortality rate and a serious complication rate of 4-5%. Stampede trial He added that much needed data will come from numerous clinical trials currently underway examining the effectiveness of bariatric surgery to reduce type 2 diabetes. One such randomized study is the Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently (Stampede) trial at the Cleveland Clinic's Bariatric and Metabolic Institute. The Principal Investigators are Drs Philip Schauer, Sangeeta Kashyap (an endocrinologist) and Deepak Bhatt (a cardiologist). The study will compare the effectiveness of advanced medical therapy alone versus bariatric surgery and therapy combined, for the treatment of type 2 diabetes during a five year study period. Patients with a BMI of 2743 will be recruited and the primary end point is the rate of biochemical resolution of type 2 diabetes at one year, as measured by HbA1c<6%. The safety and adverse event rates will also be compared between the three arms of the study. Interestingly, Schauer reported that they screened thousands of patients as many refused to be considered for both treatments strategies. The final presentation of the session was by Dr Carel le Roux, Imperial College London, who asked, ‘What does basic science today predict for future obesity treatments?’ To answer this question he examined the physiology behind bariatric procedures. For example, banding works by restriction so how does that result in patients feeling ‘less hungry’? “We know that the vagal fibres that sit at the point where the band presses on, are actually important when it comes to signalling the hypothalamus,” said le Roux. “Therefore, we now believe that it is the pressure on these fibres at the gastrooesophageal junction that actually allows people to feel less hungry.” He added that the change in hunger is not universal and estimates that 20 per cent of patients do not have a reduction in hunger, compared to 80 per cent who do have a reduction. “I think restriction is a side effect of the band and not how it works, people should be losing weight because they are eating fewer calories, not by restriction,” said le Roux. With regards to bypass, he said that one of the most common complaints patients have is constipation, but this does not equate with the malabsorptive aspects of gastric bypass. Le Roux said it was important to look at important role of the alimentary limb, “It appears that operations such as bypass fixes dysfunctional deficiency and increase the gut hormones. This does not appear to be the case with banding.” Gastric bypass also appears to alter people's food preferences, suggesting a new mechanism of bariatric surgery. “Patients become hungry for fruits and vegetables and no longer crave junk food.” He highlighted a recent study that investigated how bypass affects intake of and preference for high fat food in an experimental (rats) study. “If we can find out why this happens, we might be able to help people to eat more healthily without much effort.” “We know that the vagal fibres that sit at the point where the band presses on, are actually important when it comes to signalling the hypothalamus… Therefore, we now believe that it is the pressure on these fibres at the gastro-oesophageal junction that actually allows people to feel less hungry.” Carel le Roux medical community need to understand that obesity is a disease and just like cancer, it kills. The next speaker, Dr Philip R Schauer, Cleveland Clinic, USA, discussed ‘What clinical evidence do we need to move bariatric and metabolic surgery forward?’ He began by stating bariatric and metabolic surgery has evolved and so the evidence gathered from these procedures is less than the gold standard randomised controlled trial. Despite this, the guidelines across the national organisations (NICE, NIH etc) show a large consensus and organisations with an interest also agree about the benefits of bariatric surgery (such as national diabetes organisations). “However, despite this recognition of bariatric surgery, the adoption of surgery remains low,” explained Schauer. “In the US, although there are 200,000 procedures each year that is only 1-2% of the patients who are eligible.” Evidence In order to increase the number of procedures, Schauer said that it was necessary improve the evidence such a case studies, registries and clinical trials. Such studies should examine operative morality and complications, short and long term outcomes, weight loss, the effect on co-morbidities, cost of operation and the cost the natural progression of the disease (of not intervening). For surgery the evidence is minimal and there are only three randomised clinical studies that have examined the outcomes of surgery compared with non-surgical treatment such as medial therapy, lifestyle changes or modifications (diet, exercise). He added that the evidence so far from medical therapy based studies (such as the Look Ahead study) have shown a decrease in weight loss of some 4%, which Nicholas Christou Philip Schaur Carel le Roux 20 BARIATRIC NEWS ISSUE 11 | March 2012 ‘Last resort’ bariatric surgery beneficial in adolescents Researchers at Nation- cost and delivery as well as psychosocial wide Children’s Hospital have report- factors including educational attainment, ed that their patients have experienced a significant loss of excess body weight and showed improvement in many obesity-related diseases within the first one to two years following surgery. The retrospective study was published in the January 2012 print edition of Pediatric Blood & Cancer (Pediatr Blood Cancer 2012; 58: 112–116). “Bariatric surgery in adolescents is never a cosmetic procedure,” said the study’s author Dr Marc Michalsky, Surgical Director of Bariatric Surgery at Nationwide Children’s Hospital and faculty member at The Ohio State University College of Medicine. “These teens are very sick, they are suffering and they can benefit from weight loss surgery. Our study demonstrates the safety and efficacy of weight reduction surgery in morbidly obese adolescents.” He added that although weight loss surgery can be a very effective intervention, it should be a last resort for teenagers. According to the researchers the pediatric age group are the fastest growing sub-population of obese individuals in the US, which has been described as a a pandemic of the new millennium. In addition to the overall rise in obesity-related diseases in children, a mounting body of evidence highlights the negative impact of adolescent obesity on healthcare job absenteeism, depression, and quality of life. “We do not yet know whether the improvements of these patients will correspond to long-term resolution of weightrelated diseases or reduce their risk for future weight-related diseases,” said Michalsky who also chairs the American Society for Metabolic and Bariatric Surgery Pediatric Committee’s best practice guidelines. “Although our findings suggest that the most significant metabolic impact occurred within the first post-operative year, findings may differ in studies involving more patients who are followed longer-term." Study outline As a result, the investigators performed a retrospective analysis of patients undergoing Roux-en-Y gastric bypass (RYGB) between 2004 and 2009 at their institution. Following approval from the Institutional Review Board (IRB), a retrospective analysis of data collected from the medical records of 15 morbidly obese adolescents (ten females and 5 males) who underwent RYGB by two experienced surgeons at Nationwide Children’s Hospital (Columbus, OH) between February, 2004 and July, 2009 was performed. Standard pre-operative screening of Marc Michalsky all bariatric surgical candidates consisted of history and physical examination, nutritional screening, psychological evaluation, social work, and physical activity screening. Pre-operative blood work, overnight sleep study, upper gastrointestinal study with contrast, abdominal ultrasound, bone age and pediatric cardiology evaluation, including transthoracic echocardiography, were performed. Clinical and demographic data were collected for analysis at baseline, then one and two years post-operatively. These included age, blood pressure, height, weight, body mass index (BMI), and measurement of several metabolic markers including: fasting serum hemoglobin A1C (HbA1C), insulin level, C-reactive protein (CRP), C-peptide, glucose, and serum lipid profile. Using tables provided by the Centers for Disease Control (CDC), percentiles were calculated to account for differences in the age of the patients including BMI, total cholesterol, TG, LDL, and HDL. Insulin resistance (IR) was determined by calculating HOMA-IR. This uses fasting glucose and insulin to estimate an index of IR, as well as percentage of pancreatic beta cell function (%B) and percentage of insulin sensitivity (%S). Post-operative anthropomorphic and laboratory analyses were examined at one year (n = 14) and two years (n = 9). Percentage excess weight loss was calculated and followed over time. This was defined as (weight loss/excess weight) × 100 where excess weight is total pre-operative weight − ideal weight. Outcomes Analysis of baseline clinical data showed that the mean BMI was 58.8 ± 10.7 kg/ m2 (super morbid obesity) and a longitudinal analysis demonstrated a significant decrease from baseline over the two-year study period to a mean BMI of 34.9 ± 5.6 kg/m2 (range: 26.7–42.7 kg/m2, p≤ 0.001) with the most notable change within the first year (58.8 ± 10.7 kg/m2 vs. 37.6 ± 9.0 kg/m2, p≤ 0.001). The researcher note that although the BMI continued to decrease between the one and two-year time points, it did not reach statistical significance (37.6 ± 9.0 kg/m2 vs. 34.9 ± 5.6 kg/m2, p= 0.433). The change in mean weight also achieved statistical significance over two years (p≤ 0.001) as did the change in overall body weight over the first (179.6 ± 42.5 kg vs. 112.6 ± 29.9 kg, p≤ 0.001) but not the second (112.6 ± 29.9 kg vs. 104.9 ± 25.8 kg, p= 0.184) post-operative year. Complications Three of the patients (20%) experienced short-term including one readmission for post-operative ileus, one port-site hernia and one revision of the gastro-jejunal anastomosis secondary to bleeding and anastomotic leak. Long-term complications included one port-site hernia diagnosed at 14 weeks post-operatively and one gastrojejunal anastomotic stricture which responded to a single endoscopic dilation 14 months post-operatively. Conclusion According to the authors, the study demonstrated both safety and efficacy of weight-reduction surgery in morbidly obese adolescents and although the results suggest that the most significant metabolic impact occurred within the first post-operative year, this may have been a confounding influence of a low sample size as well as relatively shortterm follow-up. They concluded that bariatric surgery is a safe and efficacious treatment option for morbidly obese adolescents with significant obesity-related comorbid conditions and that the early surgical intervention and management of comorbid diseases may reduce the longterm burden of physical and psychological chronic disease in morbidly obese adolescents. “The argument is quite compelling that we really do need to be doing it this young to avoid the chronic burden of disease these patients will suffer from if nothing is done. Bariatric surgical operation in kids is never a cosmetic practice,” Michalsky concluded. “These youngsters are pretty sick, they’re suffering and they are apt to reap the benefits of fat reduction surgical operation. Our study displays the safeness and efficacy of weight loss surgical operation in morbidly overweight kids.” First endoluminal revision of a prior sleeve gastrectomy There were two bariatric ‘firsts’ reported at the 3rd Annual Apollo Bari- atric Surgery Conference (ABSCON 2012) in Chennai, India, in January 2012. The firsts came from one procedure, as the first ever endoluminal bariatric procedure to be performed in South Asia is also thought to be the first known endoluminal revision of a prior sleeve gastrectomy. The operation was performed by New York bariatric surgeon, Dr Elliot Goodman, and Dr Rajkumar Palaniappan, Apollo Hospital in Chennai. The operation was shown via video-link to 80 surgeons attending the ABSCON 2012 conference at the Hyatt Regency Hotel in Chennai. “This represents a tremendous milestone for the evolution of GI surgery as it progresses from open to laparoscopic and now incisionfree access,” said Dr Goodman. The patient was a 27-year-old gentleman who had previously undergone a sleeve gastrectomy for obesity in 2011. He had lost approximately 15kgs in weight, but his weight had then stabilised and he had begun to regain weight. He had a history of depression and hypertension and a pre-operative upper GI series showed that he had significant dilatation of his sleeve, particularly in the mid-portion of the remaining stomach. Utilising the Overstitch platform (Apollo Endosurgery), the team placed six endoluminal sutures along the sleeve gastrectomy staple line. At the completion of the operation, the team performed an endoscopy which showed significant reduction in the size of the gastric reservoir. The procedure lasted about an hour. “We believe that flexible surgery represents the most exciting innovation in bariatric and gastrointestinal surgery in years and we look forward to offering these incisionless procedures to our patients to help combat obesity and other conditions,” said Dr Prathap C Reddy, Chairman of Apollo Hospitals Group. After the successful performance of South Asia’s first endoluminal bariatric procedure, the Apollo Hospital bariatric surgery service will soon perform similar procedures on a regular basis. It is anticipated that the first few cases will be performed within the next couple of months. These will include sleeve gastrectomy and gastric bypass revisions for patients who have initially lost weight, but are now regaining weight due to either sleeve or pouch/stoma dilatation. The Apollo Hospital surgeons will also be examining the safety and efficacy of primary endoluminal gastroplasty in patients with a BMI of 30-40 as part of a clinical trial sponsored by Apollo Endosurgery. Specialists in clinical database software for hospitals and national/international registries • Installations in 250+ hospitals worldwide • 80+ national and international databases • Systems in 40+ countries 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 22 BARIATRIC NEWS ISSUE 11 | March 2012 Diabetes Australia support bariatric surgery for T2DM patients Diabetes Australia have released a position statement voicing their support for bariatric surgery as a method of managing diabetes. In line with the UK National Institute for Clinical Excellence guidelines, Diabetes Australia’s position statement advises that bariatric surgery is a viable weight loss treatment option for people with type 2 diabetes with a BMI over 35, where lifestyle interventions and medical treatments for obesity or diabetes have not been successful. The position paper also states that people who do not already have diabetes but are risk of developing the condition should only consider surgery if they are very obese (BMI over 40 or over 35 with an obesity-related medical condition). The association has deliberately used the word “manage” rather than “cure” in the statement, as it is not currently known how long normal blood glucose levels can be maintained without medication. “While bariatric surgery should always be considered as a last resort, more people have reached that position than ever before, so surgery is increasingly being viewed as a viable option – although not without dangers. A key issue is access for those most in need of the surgery, as public funding is much lower than demand,” said Diabetes Australia Chief Executive Officer Lewis Kaplan. An estimated 1.7 million Australians have diabetes, and 275 Australians develop the condition every day. An additional two million Australians are estimated to be at risk of developing type 2 diabetes. 61% of Australian adults are overweight, of which 25% of Australians considered obese. The position paper advocates greater public spending for bariatric surgery, noting its potential to reduce future health expenditure by preventing disease, disability and death. It also states that in Australia the majority of GLP-1 hormone can result in ‘clinically beneficial’ weight loss A study published on bmj.com claims that giving overweight or obese patients the glucagon-like peptide-1 (GLP-1) hormone can lead to clinically beneficial weight loss as well as reduced blood pressure and cholesterol levels, as the result of supressing appetite. Researchers from the University of Copenhagen, Denmark, wanted to determine whether treatment with agonists of GLP-1 receptor resulted in weight loss in overweight or obese patients with or without type 2 diabetes mellitus (T2DM). The investigators examined randomised controlled trials of adult participants with a BMI> 25; with or without T2DM; and who received exenatide twice daily, exenatide once weekly, or liraglutide once daily at clinically relevant doses for at least 20 weeks. Control interventions assessed were placebo, oral antidiabetic drugs, or insulin. Three researchers independently extracted and utilised random effects models for the primary meta-analyses. They also preformed subgroup, sensitivity, regression and sequential analyses to evaluate sources of intertrial heterogeneity, bias, and the robustness of results after adjusting for multiple testing and random errors. GLP-1 GLP-1 is one of a group of gastrointestinal proteins called incretin peptides that regulate glucose metabolism through multiple mechanisms. Because of its ability to regulate blood-glucose levels, treatment based on GLP-1 has recently been introduced for type 2 diabetes. GLP-1R drugs work by binding to the surface of cells in the pancreas, increasing their secretion of insulin. Recent trials in patients with diabetes have also suggested they could result in weight loss. The two GLP-1R agonists, exenatide and liraglutide, are both administered by subcutaneous injection, and have a restricted licence for people with type 2 diabetes. A total of 25 trials were included in the study and the analysis showed that patients in the GLP-1R agonist groups achieved a greater weight loss than control groups (weighted mean difference −2.9kg, 95% confidence interval –3.6 to –2.2; 21 trials, 6,411 participants). They found evidence of intertrial heterogeneity, but no evidence of bias or small study effects in regression analyses. The results were confirmed in sequential analyses. Recorded weight loss was seen in the GLP-1R agonist groups for patients without diabetes (–3.2kg, –4.3 to –2.1; three trials) as well as patients with diabetes (–2.8kg, –3.4 to –2.3; 18 trials). In the overall analysis, GLP-1R agonists had beneficial effects on systolic and diastolic blood pressure, plasma concentrations of cholesterol, and glycaemic control, but did not have a significant effect on plasma concentrations of liver enzymes. GLP-1R agonists were associated with nausea, diarrhoea, and vomiting, but not with hypoglycaemia. “This analysis provides convincing evidence that GLP-1R agonists, when given to obese patients with or without diabetes, result in clinically relevant beneficial effects on body weight. Additional beneficial effects on blood pressure and total cholesterol might also be achieved,” the authors note. “Intervention should be considered in patients with diabetes who are obese or overweight. Further studies are needed to elucidate the effects of GLP-1R agonists in the treatment of obese patients without diabetes.” However, writing a editorial to the study on bmj.com, Professor Raj Padwal, University of Alberta, states, “While these results highlight the weight-reducing benefits of GLP-1 agonists, they should not alter current practice, “Modification of diet and lifestyle remains the cornerstone of the treatment of T2DM…continued and close surveillance of these new agents using all available data sources is warranted.” bariatric procedures are done in private hospitals, while obesity and associated medical disorders affect people from disadvantaged and low-income backgrounds more frequently than those who are affluent. “Population-based approaches to prevent obesity should be a priority and funding to treat severe obesity with medical and surgical interventions should be made available more widely,” says the statement. Diabetes Australia say that bariatric surgery is not recommended for children and adolescents or those who are not physically or developmentally mature, citing insufficient evidence as to the long-term safety and effectiveness of bariatric procedures in young people. They also describe access to regular follow-up care as “vital” and recommend that a comprehensive service with a team of health professionals including dietitian, surgeon, physician and psychologist should be available. SOBA launches new web service – Ask SOBA SOBA (Society for Obesity and Bariatric Anaesthesia), www.sobauk.com, has launched a new service on its website called Ask SOBA, a service aimed at answering member’s queries about anaesthesia and critical care for the obese patient. Aimed primarily at SOBA members, it is also open to non-members with general queries.Please email your questions [email protected]. New members are also welcome, Membership costs only £25 per year and entitles members to: nReduced subscription to SOBA events n Quarterly SOBA newsletter n Access to the beta SOBA database project n Access to the discssion forums and educational materials BARIATRIC NEWS 23 ISSUE 11 | March 2012 CMS to offer obesity screening and counselling The Centers for Medicare and Medicaid Services (CMS) has announced that it will cover preventive services aimed at reducing obesity. This new benefit will be available without any cost sharing, as with other Medicare preventive services under the Affordable Care Act. More than 22 million Medicare beneficiaries in the US received at least one free covered preventive service in 2011. The preventive services currently offered under the Medicare program complement a new joint initiative by CMS and the Centers for Disease Control and Prevention called the Million Hearts. Medicare estimates that approximately 30 per cent of beneficiaries are considered obese and that unhealthy weight can lead to a number of chronic conditions, including cardiovascular disease and diabetes. CMS believes that by addressing obesity now, it can reduce the number of heart attacks and strokes over the next five years and improve the health of Medicare beneficiaries. “Obesity is a challenge faced by Americans of all ages, and prevention is crucial for the management and elimination of obesity in our country,” said CMS Administrator Donald M Berwick. “It’s important for Medicare patients to enjoy access to appropriate screening and preventive services.” Obesity screening and counselling for eligible beneficiaries will be offered by primary care providers in the office setting. Patients with a body mass index (BMI) of greater than or equal to 30kg/ m2 would receive one face-to-face visit for counselling each week for one month as well as a visit every other week for an additional five months. In addition, a beneficiary who has lost at least 6.6lbs during his or her first six months of counselling is eligible to receive an additional six face-to-face visits over the course of a six-month period. The Centers for Medicare and Medicaid Services (CMS) has determined “The evidence is adequate to conclude that intensive behavioral thera- Join py for obesity, defined as a body mass index (BMI) ≥ 30kg/m2, is reasonable and necessary for the prevention or early detection of illness or disability and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B and Donald Berwick is recommended with a grade of A or B by the U.S. Preventive Services Task Force (USPSTF). Intensive behavioral therapy for obesity consists of the following: 1.Screening for obesity in adults using measurement of BMI calculated by dividing weight in kilograms by the square of height in meters (expressed inkg/‑2); 2.Dietary (nutritional) assessment; and 3.Intensive behavioral counseling and behavioral therapy to promote sustained weight loss through high intensity interventions on diet and exercise. The intensive behavioral intervention for obesity should be consistent with the 5-A framework that has been highlighted by the USPSTF: 1.Assess: Ask about/assess behavioral health risk(s) and factors affecting choice of behavior change goals/methods. 2.Advise: Give clear, specific, and personalized behavior change advice, including information about personal health harms and benefits. 3.Agree: Collaboratively select appropriate treatment goals and methods based on the patient’s interest in and willingness to change the behavior. 4.Assist: Using behavior change techniques (selfhelp and/or counseling), aid the patient in achieving agreed-upon goals by acquiring the skills, confidence, and social/environmental supports 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 for behavior change, supplemented with adjunctive medical treatments when appropriate. 5.Arrange: Schedule follow-up contacts (in person or by telephone) to provide ongoing assistance/ support and to adjust the treatment plan as needed, including referral to more intensive or specialized treatment. For Medicare beneficiaries with obesity, who are competent and alert at the time that counseling is provided and whose counseling is furnished by a qualified primary care physician or other primary care practitioner and in a primary care setting, CMS covers: nOne face-to-face visit every week for the first month; nOne face-to-face visit every other week for months 2-6; nOne face-to-face visit every month for months 7-12, if the beneficiary meets the 3kg weight loss requirement as discussed below. At the six month visit, a reassessment of obesity and a determination of the amount of weight loss must be performed. To be eligible for additional face-toface visits occurring once a month for an additional six months, beneficiaries must have achieved a reduction in weight of at least 3kg over the course of the first six months of intensive therapy. This determination must be documented in the physician office records for applicable beneficiaries consistent with usual practice. For beneficiaries who do not achieve a weight loss of at least 3kg during the first six months of intensive therapy, a reassessment of their readiness to change and BMI is appropriate after an additional six month period. Screening for obesity and counseling for eligible beneficiaries by primary care providers in settings such as physicians’ offices are covered under this new benefit. For a beneficiary who screens positive for obesity with a body mass index (BMI) ≥ 30kg/m2 the benefit would include one face-to- face counseling visit each week for one month and one face-to-face counseling visit every other week for an additional five months. The beneficiary may receive one face-to-face counseling visit every month for an additional six months (for a total of 12 months of counseling) if he or she has achieved a weight reduction of at least 6.6 pounds (or 3 kilograms) during the first six months of counseling. “This decision is an important step in aligning Medicare’s portfolio of preventive services with evidence and addressing risk factors for disease,” said Dr Patrick Conway, CMS Chief Medical Officer and Director of the Agency’s Office of Clinical Standards and Quality. “We at CMS are carefully and systematically reviewing the best available medical evidence to identify those preventive services that can keep Medicare beneficiaries as healthy as possible for as long as possible.” According to the STOP Obesity Alliance, the overall costs of being overweight over a five-year period are $24,395 for an obese woman and $13,230 for an obese man. Thirty-four percent of U.S. adults are obese, according to the alliance, which expects that percentage to rise to 50% by 2030. “As small of a weight loss as 5% to 7% can lead to a huge health improvement,” said Christy Ferguson, director of the STOP Obesity Alliance. “This is good news for the millions of Americans who struggle with obesity and its serious consequences and for their doctors who care for them,” said Gary Foster, director of the Center for Obesity Research and Education at Temple University in Philadelphia. Although the rule change means that, technically, Medicare beneficiaries should immediately be able to start receiving the services without having to make a copayment, in the absence of billing or coding guidelines, it may prove difficult for physicians to provide or even refer patients for a particular service, Hughes said. 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. 24 BARIATRIC NEWS ETHICON ENDO-Surgery launches the first solution for laparoscopic sleeve gastrectomy designed to help minimise leaks Ethicon Endo-Surgery (EES) has launched the first comprehensive solution for laparoscopic sleeve gastrectomy designed to help minimise leaks. According to the company, the EES Sleeve Solution provides surgeons with cutting-edge EES surgical devices, professional education and resources aligned with the expert consensus on laparoscopic sleeve gastrectomy (see page 1). The Solution is designed to help minimise complications, deliver the best possible patient outcomes and enable cost-effective management of the procedure. The EES Sleeve Solution includes: nThe expert consensus on technique – Providing bestpractice guidelines from some of the world’s most experienced sleeve surgeons. nNEW Sleeve Solution Sets – Complete procedure sets with all the EES devices needed for this procedure, including the ECHELON FLEX 60 Stapler with the appropriate reloads, HARMONIC ACE 45cm Curved Shears and ENDOPATH XCEL Bladeless Trocars. n Professional Education – Surgeon and staff procedure training, including courses, preceptorships and proctorships, aligned to the expert consensus. n Support Tools – Materials and services to assist with patient aftercare, practice management and on-going education to optimize the procedure and patient outcomes. “The EES Solution for Sleeve Gastrectomy is truly built upon science and surgeon insights to deliver both clinical and economic value while maximising outcomes for patients,” says Eric Bruno, EES Vice President of Global Marketing. “It is also the first solution designed to help minimise leaks, which are a major concern for surgeons in this procedure.” More information about the EES Solution for Sleeve Gastrectomy is available at www.ees.com/eessleevesolution. ISSUE 11 | March 2012 Product News Award-winning Bariatric Training Suit improves bariatric care Benmor Medical has designed a Bariatric Training Suit which will help nursing staff develop the specific skills required to safely and effectively manage bariatric patients, by allowing them to practise techniques using realistic scenarios within a safe environment. The prevalence of obesity is increasing at an alarming rate and has reached epidemic proportions globally. This presents a whole new set of moving and handling challenges for nursing staff within their daily work environment as they are increasingly presented with situations where they need to manually handle bariatric patients. This management of the bariatric patient population presents many challenges for nursing staff and requires specific skills that can be difficult to master without hands on experience. Realistic Bariatric Scenarios The Bariatric Training Suit from Benmor Medical will help nursing staff combat these difficulties by enabling them to train using realistic scenarios and understand the problems associated with managing a bariatric patient without actually facing the multiple weight related risks that would apply if using actual bariatric weight during training procedures. Designed to be worn during training sessions, the Bariatric Training Suit comprises of 3 realistic body sections (arms, torso and legs) which allow the wearer to experience first- hand the mobility restrictions a bariatric patient faces on a daily basis, whilst providing their colleagues with a pseudo bariatric patient to practise moving and handling techniques without endangering themselves. The Bariatric Training Suit mimics the proportions, shape, movement and weight distribution of a bariatric patient ensuring that it is particularly useful for staff training of patient transfers and correct use of moving and handling equipment. It allows staff to develop appropriate skills and confidence in the safe handling and management of bariatric patients within their facility ensuring that they develop the practical skills and knowledge required to enable them to move and handle bariatric patients more efficiently. Award-Winning Response Despite only being launched in January 2012, Benmor Medical are already experiencing a high demand for the Bariatric Training Suit as healthcare facilities appreciate the benefits it can provide to their staff in order to reduce musculoskeletal injuries and improve the efficiency of care. This success has further been recognised by healthcare specialists during the products launch at the Moving and Handling Conference 2012 in London where it received the ‘Most Interesting New Product’ award. The Bariatric Training Suit is now available worldwide where it will continue to provide effective bariatric training to enable nursing staff to be fully proficient with handling techniques and procedures prior to admission of a bariatric patient. BARIATRIC NEWS 25 ISSUE 11 | March 2012 ReShape Medical launches next generation ReShape Duo intragastric balloon The ReShape Duoin place David Ashton presenting at ReShape Medical’s Breakfast Symposium Alberic Fiennes, Jennifer Epp and Richard Thompson Southern California- stomach during a simple, fifteen minute He also spoke about the ease of the pro- thereby limit early removals. The dual- serving as built-in portion control. based medical device man- out-patient procedure. cedures for placing and removing the balloon design also helps mitigate risk ufacturer, ReShape Medical, recently launched its new ReShape Duo intragastric dual-balloon at the British Obesity and Metabolic Surgery Society’s (BOMSS), 3rd Annual Scientific Conference 2012 held recently (19th and 20th January 2012) at the Bristol Marriott Hotel Royal, UK. The ReShape Duo is designed for those patients who have exhausted their efforts with diets alone and wish to avoid, or do not qualify for bariatric surgery. According to the company, the device comfortably occupies existing space in the stomach for six months, serving as built-in portion control, so patients feel full and satisfied with less food. The Duo can be placed in the ReShape Duo received the CE Mark in 2007 and the medical device and its associated procedure has been refined in association with Professor Franco Favrettiand his team in Vicenza, Italy. The company has just launched the product in the UK through Healthier Weight Centres under the care of Medical Director, David Ashton. As part of the conference, ReShape Medical hosted a Breakfast Symposium at which, Dr David Ashton, Medical Director of Healthier Weight gave a presentation introducing the ReShape Duo. He provided an overview of its features and benefits and discussed recent medical experience with the device in Italy and the US, referring to supporting data. ReShape Duo, details of its effectiveness, how well it is tolerated by patients and its excellent safety profile. “ReShape Duo represents a real step forward, combining dual balloons with higher fill volumes for the potential of better weight loss. The ReShape Duo offers greater comfort and there’s a lower risk of early removal,” said Ashton. Dual-Balloon benefits Filled with evenly distributed 900cc of saline, the ReShape Duo occupies 60% more space than a single balloon without over-distending the stomach, and is designed to conform better to its natural curvature to improve patient comfort during weight loss programmes, and Benmor Medical launches Aurum bariatric bed at Arab Health 2012 Benmor Medical recently has launched its new Aurum bariatric bed at Arab Health 2012 in the ABHI UK Pavilion. According to the company, obesity levels in the Gulf States are high and rising fast and the World Health Organisation claims that approximately a third of the population of the UAE, Saudi Arabia, Qatar and Bahrain are considered obese (the same proportion as the United States) and incidence is expected to rise. The Aurum 4-section electric profiling bariatric bed has been designed to facilitate safe and efficient care of the larger patient whose body weight and/ or size exceeds that of a standard bed. Combining functionality and aesthetics the Aurum is strong and durable enough for all bariatric care situations, whilst providing a comfortable environment for improved patient care and tranquillity, the company claims. Key features of the Aurum such as width adjustment, integrated weighing and removable/adjustable safety rails provide a safe environment within which to improve the moving and handling of larger patients up to 65stone/910lbs/413kg and ensure ease of care and safer working conditions for nursing staff and carers. “We are continually driving innovation and quality within the bariatric market and have established a firm reputation for excellent cus- tomer support and class leading products,” said Peter Staddon, Managing Director. “We are confident that our range of bariatric products will create significant interest in the Middle East healthcare market and allow us to meet companies who share a passion for our products and with whom we can develop fruitful longterm relationships.” Benmor Medical has been supporting bariatric care since 1996 and was the first company in the UK specialising in bariatric patient handling equipment. As pioneers within the UK market for bariatric equipment Benmor Medical has been at the forefront of the development of products and solutions that have helped to raise the standards of bariatric care within the UK. Now the company is taking its range of innovative bariatric solutions to the Middle East. of migration and/or obstruction. The ReShape Duo has been used successfully in Europe since 2007 with patients comfortably losing, on average, one-third of their excess weight in six months. ReShape Duo procedures The ReShape Duo can be placed and removed in fifteen minute outpatient procedures under conscious sedation. The procedures are completely nonsurgical – no incisions, sutures or scars. Placement: the un-inflated balloons are advanced over a guide wire and precisely placed in the stomach. Each balloon is inflated with saline and independently sealed. The device is released and remains in the stomach for six months, ReShape Duo availability Following ReShape Duo’s launch, Healthier Weight has confirmed that the Reshape Duo will be available through its network of weight loss centres throughout the UK and beyond in London, Birmingham, Manchester, Southampton and Cardiff. “We were gratified by the genuine interest shown in the ReShape Duo,” said ReShape Medical President and CEO, Richard Thompson. “The meeting confirmed that many UK doctors are seeking nonsurgical alternatives to offer their patients who do not want or do not qualify for bariatric surgery.” ReShape Duo is not yet approved for use in the US. 26 BARIATRIC NEWS ISSUE 11 | March 2012 Calendar of events March 11-14 April 20-21 June 17 – 22 September 20-24 10th International Anniversary Expert Meeting for the Surgery Obesity and Metabolic Disorders Second International Symposium on Non-invasive Bariatric Surgery American Society for Metabolic and Bariatric Surgery 29th Annual Meeting Obesity 2012 Saalfelden, Austria www: obesity-online.com/expertmeeting Lyon, France Phone: 00 33 (0)4 72 01 45 00 Fax: 00 33 (0)4 72 01 45 05 San Diego CA www.asmbs.org March 22-25 May 9-12 May June 20-23 European Association for the Study of Obesity 19th European Congress 2012 (ECO-EASO 2012) 20th International Congress of the European Association for Endoscopic Surgery (EAES) Rio De Janeiro, Brazil www: codhy.com/LA/2012 Lyon, France Phone: +44 20 8783 2256 Fax: +44 20 8979 6700 www: easo.org/eco2012 Brussels, Belgium www.eaes.eu April 11-13 May 23-27 Endocrine Society’s 94th Annual Meeting 2nd Latin America Congress on Controversies to Consensus in Diabetes, Obesity and Hypertension 2012 (CODHY 2012) OSSANZ Darwin, Australia www: ossanz.com.au email: [email protected] American Association of Clinical Endocrinologists Annual Meeting 2012 Philadelphia, PA http://am.aace.com April 20 June 23-26 Houston, Texas www.endo-society.org 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/ September 11-15 IFSO New Delhi, India www.ifsoindia2012.org SOBA York, UK www: sobauk.com If you would like to place your meeting details here, please email: [email protected] The next issue of Bariatric News is out in May 2012 Editorial deadline: 23 May 2012 Advertising deadline 23 May 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 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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