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BNEWS ARIATRIC THE NEWSPAPER DEDICATED TO THE TREATMENT OF OBESITY FOR THE HEALTHCARE PROFESSIONAL Bariatric surgery in Kuwait 6 Coffee Time Professor Mervyn Deitel talks to Bariatric News about his career and the evolution of bariatric surgery 8 Mini-Gastric Bypass Conference A special report from the 2nd International Consensus Conference 13 Variety of factors The impact of bariatric surgery on risk factors for cardiovascular disease depends on a variety of factors, including the type of surgery, sex, ethnic background, and pre-surgery BMI 25 Country news 36 Based on projections, it would take more than ten years to recover the costs of the LRYGB procedure. Canada: Access to surgery Nicolas Christou discusses access to bariatric surgery in Canada under the publically-funded healthcare system Page 17 42 between January 2003 and September 31 2009. LAGB and LRYGB claimants were propensity score matched to two control samples: one restricted to those with a MO diagnosis code and one without this restriction. The random sample of 120,000 individuals was provided directly from Medstat. Propensity score matching was used to ensure that the four groups were as similar as possible. LRYGB patients were matched to LAGB patients based on patient and health plan characteristics, and on diagnoses and costs in the year prior to the quarter before the bariatric procedure. Using the four matched samples, an analysis data set was created that included quarterly payments of total, inpatient (both facility and physician), non-inpatient (including payments for hospital outpatient, physician’s office visits, and emergency department), and prescription drug claims. Each quarter represented the time relative to (pseudo) band placement. T he time taken to recuperate the costs from bariatric surgery are more likely to be double the 5.25 years previously estimated for laparoscopic adjustable gastric band (LAGB), according to a study that assessed ‘The Business Case for Bariatric Surgery Revisited: A Non-Randomized Case-Control Study business case for bariatric surgery’, published online in the journal PlosOne (October 2013). The authors conclude that the time to recuperate the costs from laparoscopic Roux-en-Y gastric bypass (LRYGB) would be even greater given the procedure results in increased hospital stay and procedure time. The study authors state that previous studies that have examined the cost of bariatric surgery have relied on a comparison sample of those with a morbid obesity (MO) diagnosis code, despite the fact that this high cost group might not be a true reflection of patients who eventually have LAGB or LRYGB procedures. As a result, this study re-estimated the net costs and time to recuperate the costs using an alternative sample that does not rely on the MO diagnosis code. “Regardless of the time to break even, it is worth pointing out that the expectation for any surgical intervention to show a return on investment is unusual and few effective interventions reach this threshold,” the authors state. “LAGB, however, may be one of the Results A total of 9,631 patients (after matching), were includexceptions.” The analysis is based on claims data from the Mar- ing in each surgical group. The groups of patients are Continued on page 3 ketScan Commercial Claims and Encounters database Apollo Endosurgery buys Allergan’s obesity unit Medicare CoE policy could limit minority access to surgery pollo Endosurgery has completed the acquisition of the obesity intervention division of Allergan, which manufactures and sells weight loss solutions comprised of the Lap-Band adjustable gastric banding system and the Orbera intra-gastric balloon system. “With worldwide obesity numbers reaching epidemic levels, the acquisition of the Lap-Band and the Orbera technologies places Apollo Endosurgery in a leadership position to provide surgeons and patients with innovative and less invasive solutions in the fight against obesity,” said Dennis McWilliams, President and CEO of Apollo Endosurgery. “By expanding both our product portfolio and adding Evidence supporting or discontinuing bariatric CoE is ‘inconclusive’ A Industry and product news 39 Calendar of events Clinical comment More time needed to recuperate the costs of bariatric surgery IN THIS ISSUE… In an exclusive interview with Dr Salman Al Sabah we report on the current status of bariatric surgery in Kuwait ISSUE 18 | DECEMBER 2013 talent to our team, this acquisition will be a catalyst for growth as we continue to advance technologies in the fields of bariatric and minimally invasive surgery.” Apollo, who announced the acquisition in October 2013, will purchase the unit for up to US$110 million. This total includes an upfront cash payment of US$75 million, a minority equity interest in Apollo by Allergan of US$15 million, and up to US$20 million in additional contingent consideration to be paid upon achievement of certain regulatory and sales milestones. The deal comes after a year of speculation, since the Allergan announced they were planning to sell the unit in October Continued on page 36 T he policy of treating Medicare bariatric surgery patients at high-volume hospitals designated as Centers of Excellence could be blocking obese minorities’ access to care, according to ‘Bariatric Surgery in Minority Patients Before and After Implementation of a Centers of Excellence Program’, published online in JAMA (JAMA. 2013 310(13):1399400.). The study, which compared rates of bariatric surgery for minority Medicare vs. non-Medicare patients before and after implementation of a Medicare coverage policy, reported a decline in the number of minority patients with Medicare receiving bariatric surgery after the policy was implemented. “The Medicare centers of excellence policy was associated with a 4.7 percentage point (17 percent) decline in the proportion of Medicare patients receiving bariatric surgery who were non-white,” said Dr Lauren Hersch Nicholas, lead author of the letter and an assistant professor with the Department of Health Policy and Management at Johns Hopkins Bloomberg School of Public Health. “It appears Continued on page 3 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: 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 Reveal • Interpret • Improve The Hub – Station Road – Henley-on-Thames – RG9 1AY – United Kingdom Phone: +44 1491 411 288 – e-mail: [email protected] – www.e-dendrite.com NHS Gastric band (on 09 / 04 / 2008) 08 / 07 / 2009 23 / 07 / 1967 Clinic date: Date of birth: % • Creates graphs displaying Excess Weight Loss over time • Links to hospital systems to pre-populate demographic fields • Allows the easy export of data to national/ international registries • Simplifies the data collection process • Maintains patient anonymity and confidentiality (safe and secure) Excess weight loss / • Allows the tracking of procedures and outcomes from all type of bariatric procedures (including bands, balloons, Roux-en-Y, gastric sleeve, duodenal switch and BPD) • Provides detailed tracking of comorbid conditions • Facilitates longitudinal follow-up • Automatically identifies followup breaches • Reduces the workload by automating production of patient reports, operation notes and follow-up letters Unsatisfactory (specify) 750 0 P RP R Primary Revision as a primary Revision S Planned 2 nd stage F Follow up bariatricnews.net 3 ISSUE 18 | DECEMBER 2013 More time needed to recuperate the costs of bariatric surgery Figure 1 Figure 2 Continued from page 1 predominantly female and average 44 years old at the time of surgery. Approximately 25% have diabetes and the prevalence of comorbidities ranged from 8.4% for asthma to 44% for hypertension. Payments for the LAGB sample in the year before the quarter before surgery averaged US$9,971, whilst for LRYGB patients the payment was US$10,554. The authors note that the MO sample is about three years older than the LAGB sample and has a smaller percentage of females (65.7% vs. 79.1%). They also report that although the prevalence of the included comorbidities is statistically lower than in the surgery samples, the annual costs are more than US$1,500 greater for the MO sample. “This suggests that other differences are making this sample more expensive,” they claim. Figures 1 and 2 (above) provide graphical representations of the cost trends pre- and post- (pseudo) surgery for total, inpatient, outpatient, and pharmaceutical costs. The first (surgery) quarter, was not included as including this would reduce the scale to the extent that trends would not be observable. Costs for the LAGB and LRYGB samples in this quarter were US$21,980 and US$29,900 for the full sample and US$22,480 and US$31,150 for the diabetes subsample, respectively. These figures reveal a slight increase in costs for the surgery samples in the run-up to surgery. In the second quarter, the researchers noted a reduction in costs primarily for pharmaceutical payments such as diabetes medications. “Costs for the MO sample immediately escalate post pseudo surgery, largely driven by a sharp increase in inpatient costs, thus revealing significant underlying differences between this and the matched random sample,” the authors state. “This increase in MO costs is driven by higher rates of admissions. Roughly one-third of the MO sample had an admission post pseudo-surgery, whereas this figure is 10% for the remaining samples.” When compared to the MO sample, costs for LAGB and LRYGB appear to be fully recovered in 1.5 (CI 1.45 to 1.55) and 2.25 years (CI: 2.07 to 2.43), respectively. Subsequently, the authors claim that these procedures appear to generate “significant savings” at five years: US$78,980 (CI: $62,320 to US$100,550) for LAGB and US$61,420 (CI: US$44,710 to US$82,870) for LRYGB. Some of the difference in savings between the two procedures results from the higher estimated surgical costs for LRYGB (US$16,680 vs. US$22,140). The outcomes are more significant for the diabetes subsample, Table 1. Time to Breakeven and Net Costs for Full and Diabetes Samples. Time to Breakeven (Years) 5-year Net Costs (United States Dollars) Morbid Obese Sample Sample LAGB LRYGB LAGB LRYGB Full sample 1.5 (1.45 1.55) 2.25 (2.07 2.43) −78,980 (−100,550-62,320) −61,420 (−82,870-44,710) Diabetes subsample 1.25 (1.02 1.48) 1.75 (1.49 2.01) −127,590 (−167,590-94,840) −103,340 (−146,760-65,550) Sample LAGB LRYGB LAGB LRYGB Full sample 5.25 (4.25 10+) 10+ 690 (−6,800 8,400) 18,940 (10,390 26,740) Diabetes subsample 4.25 (3 10+) 10+ −3,060 (−13,230 7,930) 21,610 (3,330 42,570) Random Sample Note: LAGB = laparoscopic adjustable gastric band; LRYGB = Laparoscopic Roux-en-Y Bypass with costs fully recovered in 1.25 (CI: 1.02 to 1.48) years for LAGB and 1.75 (CI: 1.49 to 2.01) years for LRYGB and even larger estimated savings at five years; US$127,590 (CI: US$94,840 to US$167,590) for LAGB and US$103,340 (CI: US$65,550 to US$146,760) for LRYGB (see Table 1). However, when comparisons are made to the matched random sample the estimated time to recover the costs of a LAGB procedure increases to 5.25 (CI: 4.25 to 10+) years for the full sample. Five-year net costs (not savings) are US$690 (CI: $-8,400 to $6,800). For LRYGB net costs at five years are US$18,940 (CI: $10,390 to $26,740). Based on projections, it would take more than ten years to recover the costs of the LRYGB procedure. Regarding the diabetes subsample, when compared to the matched random sample the estimated time to recover the costs of a LAGB procedure is 4.25 (CI: 3 to 10+) years and five-year net costs are now negative, revealing a savings of US$3,060 (CI: US$-7,930 to US$13,230). For LRYGB, the net costs remain positive (i.e., no savings) at five years; US$21,610 (CI: US$3,330 to US$42,570) and, based on projections, it would again take more than ten years to recover the costs of the procedure. The authors state that any return on investment for bariatric surgery depends on three factors: 1) the cost of the surgical procedures 2) the subsequent cost profile among those who undergo the procedure 3) what their costs would have been Medicare CoE policy could limit minority access to surgery Continued from page 1 that a policy intended to improve patient safety had the unintended consequence of reduced use of bariatric surgery by minority Medicare patients.” Hospitals are recognized as centers of excellence if they submitted data to a registry, have adequate protocols for care of morbidly obese patients, and perform at least 125 bariatric procedures annually. Researchers examined bariatric surgery discharge abstracts from 228,136 patients undergoing bariatric surgery in 429 inpatient hospitals in eight states and compared the proportion of minority patients undergoing bariatric surgery with and without Medicare before and after implementation of the policy change. Non-Medicare patients were used as a control group to isolate associations with the Medicare policy change relative to trends among all bariatric surgeries over the study period. In addition, researchers compared the number of white patients with those from all other minority groups. Results Of 228,136 patients, 18,607 (8.2%) had Medicare; 4,909 Medicare patients (26.4%) and 58,729 nonMedicare patients (28.0%) were non-white, and 54,415 non-white patients (85.5%) were black or Hispanic. The proportion of Medicare patients undergoing bariatric surgery who were non-white was 27.5% before the 2006 National Coverage Determination and stable after the NCD (25.9%; change, −1.5 percentage points [95% CI, −4.0 to 0.87]). However, the proportion of non-white patients increased from 26.2% to 29.1% (change, 2.9 percentage points [95% CI, 0.88 to 5.0]) among non-Medicare patients. After adjusting for patient state and time trends common to all patients, the Medicare COE policy was associated with a 4.7 percentage point decline (95% CI, −7.3 to −2.7) in the proportion of non-white patients with vs, without Medicare receiving bariatric surgery, representing 17% of the proportion (4.7/27.5) before implementation of the NCD. Earlier studies documenting better surgical outcomes at hospitals with higher procedure volume have prompted proposals to concentrate elective surgery in high-volume settings; these policies have been little-used in practice. “Policies restricting patients to Centers of Excellence could lead to serious issues including, reducing access for vulnerable populations,” the authors write. To date, bariatric surgery is the only procedure for which the Centers for Medicare and Medicaid Services (CMS) have experimented with restrictions to high-volume hospitals.cmS recently decided to eliminate the Centers of Excellence requirement after studies suggested little if any safety benefit to bariatric Centers of Excellence. “Morbidity and mortality associated with bariatric surgery have declined in recent years and safety gains from limiting hospital choice are likely lower than they were when the national in the absence of the surgical intervention. “Regardless of the time to break even, it is worth pointing out that the expectation for any surgical intervention to show a return on investment is unusual and few effective interventions reach this threshold,” the authors state. “LAGB, however, may be one of the exceptions.” “These results reveal that the net costs and time to break even resulting from bariatric surgery are less favourable than has been reported in prior studies,” they conclude. “Yet, even with a more conservative and likely more accurate comparison sample, the business case for LAGB appears favourable. Regardless, the decision of which procedure is right for a given individual depends on many factors, although cost is likely to be a significant consideration.” The study authors were Eric A Finkelstein (Health Services and Systems Research, Duke-NUS Graduate Medical School, Singapore, Global Health Institute, Duke University, Durham, North Carolina, USA), Benjamin T Allaire (RTI International, Durham, North Carolina, USA), Denise Globe (Global Health Outcomes Strategy and Research, Allergan Inc., Irvine, California, USA) and John B Dixon (Department of General Practice, School of Primary Health Care, Monash University, Melbourne, Australia, Human Neurotransmitters Laboratory, Vascular and Hypertension Unit, The Baker-IDI Heart and Diabetes Institute, Melbourne, Australia). coverage decision was implemented in 2006,” concluded Nicholas. “Our findings are important for bariatric surgery and also serve as a cautionary tale about the potential for unintended consequences if selective referral policies are extended to other procedures.” Viewpoint In an accompanying Medicare Policy on Bariatric Surgery Decision Making in the Face of Uncertainty. ‘Viewpoint’ article, Drs Sean R Tunis and Donna A Messner, of the Center for Medical Technology Policy, Baltimore, state that the arguments or more importantly, the evidence as to whether CoE centres achieve better results than institutions without accreditation is ‘inconclusive’. “The available scientific evidence neither proves nor refutes the hypothesis that accreditation improves health outcomes, meaning that Medicare will need to make its final decision by the end of September based on other clinical and public health considerations,” they write. Interestingly, the point towards varied ‘evidence’ Continued on page 5 4 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 DiaRem predicts diabetes remission following surgery DiaRem system is based on four readily available preoperative patient characteristics R esearchers have developed a simple scoring system that can predict which candidates for gastric bypass surgery are likely to achieve diabetes remission within five years. The ‘DiaRem’ system, developed by investigators from Geisinger Health System, Danville, PA, is based on four readily available preoperative patient characteristics; insulin use, age, hae- moglobin A1c concentration (HbA1c; a measure of blood sugar), and type of anti-diabetic drugs. “Our novel DiaRem score will give patients and physicians a scientifically valid way of assessing the merits of gastric bypass surgery for treating diabetes and deciding whether additional measures should be taken to improve the odds of remission”, said lead author George Argyropoulos from the Geisinger Health System, Danville, PA. The research paper entitled ‘Preoperative prediction of type 2 diabetes remission after Roux-en-Y gastric bypass surgery: a retrospective cohort study’ was published in The Lancet Diabetes & Endocrinology journal. To create the scoring system, the researchers retrospectively analysed the outcomes of 690 obese patients with type 2 diabetes who underwent RYGB between 2004 and 2011 at the Geisinger Health System Clinic, 463 (63%) patients achieved partial or complete remission. Multiple logistic regression models considered 259 clinical variables to identify independent predictors of early remission (beginning within the first two months after surgery and lasting a minimum of 12 months) and late remission (beginning more than two months after surgery and lasting at least another 12 months). Patients were assigned a weighted DiaRem score (ranging from 0 to 22) based on four factors that were independently predictive of remission, and their scores were derived by assigning a certain number of points to each of the four factors. The researchers found that patients with a low DiaRem score had the highest chance of remission after surgery, while those with a higher score were less likely to achieve remission. “For example, an individual with a BMI 39 and a DiaRem score of 22 could benefit from RYGB surgery in terms of weight loss, but would have low probability of diabetes remission”, said Argyropoulos. “Our score is robust with various definitions of diabetes remission – complete, partial, or a combination – and also predicts the probable improvement in glycaemic control after RYGB surgery.” The performance of the score was validated in two independent cohorts totalling 389 patients based on diabetes remission at 14 months. As in the primary cohort, the proportion of patients achieving remission was highest for the lowest scores and lowest for the highest scores. Four-year-old undergoes bariatric surgery I n news that will surprise and shock in equal measure, an Indian child of four years and 10 months has become the youngest person in the world to have bariatric surgery. The child, Rishi Khatau from Kolkata, was morbidly obese and weighed 44.5kgs (98.1lbs) prior to surgery. He was also diagnosed with Prader Willi Syndrome (PWS), a rare genetic disorder caused by deletion or disruption of genes, and can result in low muscle tone, short stature, incomplete sexual development, cognitive disabilities, problem behaviours, and a chronic feeling of hunger that can lead to excessive eating and life-threatening obesity. “Rishi suffered severe difficulty in breathing while sleeping wherein his oxygen saturation levels dropped below 60 per cent leaving him gasping for breath,” said Dr Mahendra Narwaria form Ahmedabad-based, Asian Bariatrics Hospital. “Generally, we would avoid bariatric surgery in such a young child but his problem could have been fatal. Exercise and controlling diet was not an option as due to his weight, he could not exercise while his genetic condition made him crave for food.” As a result of his condition, Rishi consumed 1,500 calories per day and he also presented with sleep apnoea and breathing problems, which became so acute that he could not sleep lying down for more than ten minutes as he would wake up gasping for breath. “In obese children, the intra-abdominal pressure becomes very high, there is not enough space for the lungs to expand to full capacity,” said Narwaria. “This leads to less oxygen in the body. The disturbed exchange of gases also leads to water retention and hence more weight gain.” According to the surgical team there were many challenges managing such a young patient both during operation and post-operatively. Dr Mahendra Narwaria with Rishi Khatau The banded gastric bypass: a new frontier or back to the future? “Since Roux-en-Y Gastric Bypass is primarily a restriction operation, just as with VBG, it is important that the outlet of the pouch does not stretch.” Edward Mason (Obesity Surgery 1994;4:66-72) T he rise in the number of banded gastric bypass procedures underlines acceptance by bariatric and metabolic surgeons of the importance of the gastric reservoir size, as a determinant of how the gastric bypass operation effects weight loss and weight loss maintenance. And there is now a growing body of evidence to support banded gastric bypass procedures. “As more patients undergo surgical intervention there will be more patients at risk of inadequate weight loss or weight regain resulting in failure,” said Dr MAL Fobi from the Center for surgical Treatment of Obesity, Carson, California, speaking at the recent IFSO meeting in Istanbul. “Putting a ring around the gastric pouch to control the reservoir size is a good adjunct to the gastric bypass operation for obesity.” Failure He began by explaining that the literature is replete with articles documenting inadequate weight loss and weight regain in a subset of patients after the short limb gastric bypass. “These account for a 25-40% failure rate after most gastric bypass operations,” said Fobi. “Though failure may be due to complications and patient non-compliance, cumulative experience have attributed failures to increase in the size of the reservoir.” The literature shows that the predicted percentage of maximal weight lost after RYGB was regained in five years, after the procedure at different GJ stoma diameters based on the linear regression model (Clinical Gastroenterology and Hepatology 2011; 9:228-233). Furthermore, endoscopic and radiological findings show that dilated stomas, up to 4cm wide after gastric bypass, is the cause for weight regain Figure 1:Reservoir capacity of a gastric bypass operation is initially the size of the tubular pouch. Reservoir capacity (dilated reservoir) negates the restrictive mechanism of the operation Figure 2: Placement of a ring around the gastric pouch controls the reservoir size two-to-three years after gastric bypass. Fobi explained that a dilated stoma converts the pouch and the proximal small bowel into a neopouch – a larger reservoir that can accommodate as much as the initial stomach – causing inadequate weight loss and weight regain after gastric bypass. The reservoir capacity of a gastric bypass operation is initially the size of the tubular pouch created by the surgeon at the time of operation (Figure 1). However, the reservoir capacity in most patients after the first year is made up of the dilated pouch and the dilated proximal small bowel. This increased reservoir capacity (dilated reservoir) negates the restrictive mechanism of the operation allowing the patient to tolerate more caloric intake and minimising the weight loss or enhancing the weight regain seen after the operation Banded solution “The placement of a Ring forces the use of a small tubular pouch with a standard stoma,” said Fobi. “Placed 3-4cm from the GE-junction and at least 1.5cm above the gastro-jejunal anastomosis and loose around the pouch at time of banding, the Ring enhances the restrictive mechanism of a gastric bypass by establishing a controlled reservoir, resulting in more weight loss in more patients, even the super obese and also enhances weight loss maintenance.”(Figure 2) The literature supports this notion: Awad et al (Obesity Surgery. 2012;15:724) reported that there is a significant difference in %EWL for banded patients at 36-96 month. In addition, comparative studies of the banded vs. non “We had to use specific sleeve sizer and smaller stapler to perform the surgery to reduce the size of his stomach to one third,” said Narwaria. “Since he is a growing child, we have not bypassed any portion of his intestine so that he does not suffer any malnutrition. His stomach will grow to its normal size as he grows up.” At present, Rishi is on a liquid diet and able to consume just 400 calories a day. He is using a noninvasive ventilator (BiPEP) to maintain his oxygen levels. In time, he will receive mashed food before being able to have the normal food. He is expected to lose 60% to 80% of his pre-surgical weight. The other doctors in the team who helped managing this case were Dr Nidhish Nanavati (paediatrician), Dr Ajay Shah (pulmonologist), Dr Vivek Arya (endocrinologist), Dr Yogesh Tank and Dr Parag Gohil (anaesthesiologist) and Ms Devanshi Choksi (nutritionist). banded gastric bypass show better weight loss in the banded group (Bressler M. et al Obesity Surgery 2006; Carvajal JJB et al Obesity Surgery 2006;16;225; Karcz K. Abstract Obesity Surgery. IFO2012; Lemmens L. Abstract Obesity Surgery. IFSO 2012). The views of Fobi were also echoed by another luminary of the bariatric specialty, Dr Mervyn Deitel (Editor Emeritus of the Obesity Surgery journal), who said at the IBC-IFSO 2013 Symposium: “If you want a long-term effective restrictive bariatric operation – put a Ring (band) on it.” Low complication rate Fobi also noted that whilst there have been recorded instances of band erosion, kinking or slippage, and solid food intolerance, the literature shows these occur in less than 1%, 2% and 5% of cases and can often be treated endoscopically, removal/replacement and by nutritional counselling, respectively. However, also presented at the IFSO meeting, Dr Alex Heylen, The Wellness Kliniek, Genk, Belgium, reported that in his series of 145 patients not a single instance of ring erosion in a six year period. In addition, Luc Lemmens reported 0.4% instance of erosion at the same meeting, and data from the GaBP Ring System FDA Clinical Trial show an erosion/penetrating ulcer rate of 1.1% (n=3/276). “The banded gastric bypass controls the pouch size resulting in increased weight loss and enhanced weight loss maintenance,” concluded Fobi. “It decreases the incidence of gastric outlet stenosis and decreases the severity of postprandial dumping, whilst minimising the incidence of reactive hypoglycaemia. The banded gastric bypass is not only the “New Frontier” – it is “Back to the Future” since now there are prefabricated, standardised and sterilised devices available for easy implantation for banding the pouch.” For more information about the banded procedures, please visit Bariatric Corporation bariatricnews.net 5 ISSUE 18 | DECEMBER 2013 Surgical groups ‘disappointed’ as Medicare drops CoE designation Decision based on ‘sufficient’ evidence that certification does not improve outcomes T needs of its patient population.” This latest ruling marks a reversal of a CMS policy enacted in 2006 that made facility accreditation a requirement for Medicare coverage. It also makes CMS the only major insurer that does not require bariatric surgical procedures be performed at an accredited center. Blue Cross Blue Shield, Aetna, Cigna and United Healthcare have each embraced and continue to support accreditation. Medicare will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a BMI >35 in those with at least one comorbidity related to obesity who previously have been unsuccessful with medical treatment for obesity. Disappointment The American Society for Metabolic and Bariatric Surgery and the American College of Surgeons have expressed their disappoint at the Centers for Medi- Jamie Ponce John Morton care & Medicaid Services (CMS) recent decision that it will no longer require Medicare patients to undergo bariatric surgical procedures at accredited facilities. The ruling means that eligible Medicare patients may have bariatric operations performed at any centre they choose, even those facilities with little experience in handling high-risk patients. “We are disappointed and in strong disagreement with a ruling that appears to disregard overwhelming scientific evidence and medical opinion that bariatric accreditation programs save lives, improve patient outcomes, and enhance the quality of care,” said Dr Jamie Ponce, President of the American Society for Metabolic and Bariatric Surgery (ASMBS). Approximately 750 inpatient and outpatient bariatric centres throughout the US are accredited by either the ASMBS or ACS. In 2012, the two surgical societies combined their respective programs and formed the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), to establish a national standard for accreditation and quality improvement that requires participating facilities to undergo a peer-evaluation process, follow data submission requirements, and demonstrate experience in managing bariatric surgical patients before, during, and after their procedures in order to receive accreditation. “The standards required for accreditation provide important lifesaving safeguards for patients, particularly for Medicare beneficiaries, who have a higher risk of morbidity and mortality than the general bariatric surgery population,” said Dr David B Hoyt, Executive Maintain long-term weight loss with the GaBP Ring Autolock System™ The GaBP Ring is a pre-fabricated, standardized and sterilized silicone device designed specifically to control the reservoir capacity in the gastric bypass, gastroplasty and sleeve gastrectomy operations. Placement of the GaBP Ring around the proximal pouch results in increased weight loss and long-term weight loss maintenance. Advert Medicare CoE policy could limit minority access to surgery Non-Medicare 30 25 20 Non-white (%) he Centers for Medicare & Medicaid Services (CMS) has ruled it will no longer require Medicare patients to undergo bariatric surgical procedures at accredited facilities. The ruling means that eligible Medicare patients may have bariatric operations performed at any center they choose, even those facilities with little experience in handling high-risk patients. The decision is effective from 25 September 2013. The CMS based their decision on ‘sufficient’ evidence to conclude that certification does not improve health outcomes for Medicare beneficiaries. Although the organisation has agreed that there is a role for accreditation programmes, it said that they are not necessary to ensure safe outcomes for Medicare beneficiaries. “The removal of a coverage requirement does not require facilities to discontinue practices which they find beneficial,” according to the decision memo. Facilities may choose to continue with certification in order to distinguish themselves from the competition, for instance. “While CMS agrees with the value of the multidisciplinary team approach and structure, we do not believe that every valued endeavour needs to be buttressed by a Medicare mandate,” the memo states. “We expect all facilities to strive to provide the proper equipment and services to meet the Director of the ACS. “We encourage Medicare patients to continue to select an accredited centre for bariatric surgery.” The new ruling marks a reversal of a CMS policy enacted in 2006 that made facility accreditation a requirement for Medicare coverage. It also makes CMS the only major insurer that does not require bariatric surgical procedures be performed at an accredited center. Blue Cross Blue Shield, Aetna, Cigna and United Healthcare have each embraced and continue to support accreditation In addition to the ASMBS and ACS, other professional groups supporting accreditation and opposing the new CMS ruling are The Obesity Society, Academy of Nutrition and Dietetics, American Society of Bariatric Physicians (ASBP), American Association of Clinical Endocrinologists (AACE), and Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). “MBSAQIP will continue to build upon bariatric surgery’s legacy of quality improvement, which has previously included a four-fold decline in mortality over the past decade, by initiating a new program in decreasing readmissions,” said Dr John Morton, ASMBS Secretary-Treasurer and Associate Professor of Surgery at Stanford University. “We have made great strides in surgical techniques, patient care, and in identifying potential risks and managingcmplications,” Ponce wrote in a message to ASMBS members. “But we cannot become complacent when it comes to patient safety and procedure effectiveness. We are committed to continuous quality improvement and accreditation is the mechanism by which we can best achieve it.” 15 10 5 0 2004 2005 2006 2007 Year 2008 2009 Figure 1: Proportion of minority patients undergoing bariatric surgery before and after the Medicare NCD, 2004-2009 WWW.BARIATEC.COM +1-(310)-515-3787 Continued from page 3 as to why there has been a significant improvements in patient outcomes, specifically the move to open to laparoscopic procedures including adjustable gastric banding. When shifts toward safer surgical procedures. They also note that the number of procedures has increased in conjunction with surgical experience, technique and technology, thereby reducing the complication and re-operation rates, as well as improving perioperative patient management. “However, it is possible that some hospitals, and perhaps many, will discontinue activities that are currently required to obtain COE status, and patient outcomes will worsen. This is the strong consensus view of the bariatric surgical community,” they conclude. “Although such collective professional judgment usually does not influence evidence-based policy making, its relative importance is greater when the overall body of scientific evidence is inconclusive as in this case.” The research was supported in part by the National Institute on Aging and the Agency for Healthcare Research and Quality. 6 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 Bariatric surgery in Kuwait: an interview with Dr Salman Al Sabah With 80% of its population overweight, 47.5% obese and ranking the 8th fattest population worldwide, Kuwait has a serious obesity problem. This has lead to widespread practice of bariatric surgery. Dr Salman Al Sabah, Director of Surgical Research and Academic Program in the Department of Surgery, Consultant Surgeon at Al Amiri hospital, Kuwait, Director of the First and Second Kuwait Bariatric & Metabolic Surgery Conference and the First Gulf Obesity and Metabolic Surgery Society (GOSS) Meeting which is to be held in Kuwait on December 12-14 December 2014, talks to Bariatric News regarding educating the region about the dangers of ‘diabesity’ and the aims and themes of the First GOSS meeting. T IRAN IRAQ Bubiyan KUWAIT Faylakah Al Jahrah Salman Al Sabah Kuwait City Persian Gulf he rise and prevalence of “One of the main challenges facing “Fast food in Kuwait, especially Kuwait obesity in Kuwait (and the diabetics is the lack of knowledge and after the Gulf War, flooded the malls and wider Gulf region) has been well empowerment to take control of their the nation,” he added. “It is cheap, fast documented with 36% of men and 48% diabetes,” said Dr Salman Al Sabah. “In and convenient. The weather is another of women being nationally classified as 2011, The Diabetes Kuwait Resource factor in the Gulf’s weight problem. In obese while 74% of men and 77% of Centre was established and is dedicated the summer, temperatures soar to 110F women are overweight or obese. (Obes to provide diabetes focused education or 120F making it impossible to walk Rev. 2011 Jan;12(1):1-13). and support for individuals, fam- outdoors.” SAUDI ARABIA “Ten percent are classified morbidly ily members, and the public of Kuwait In addition, the economic explosion obese,” said Dr Salman Al Sabah. “Ac- thereby improving the lives of all those in Gulf region (United Arab Emirates tually, the numbers are worse: Only 12 affected by diabetes and increasing (UAE), Saudi Arabia, Kuwait, Bahrain, every aspect of the traditional Kuwaiti with the participation of world class percent of Kuwaitis have a BMI below overall awareness.” Qatar, Oman), after the discovery of lifestyle, in terms of nutrition, physical regional and international faculty. Our GOSS meeting will include workshops, 25.” According to a study published In addition, the Dasman Diabetes oil, created the perfect breeding ground activity, and access to healthcare. in June by the London School of for non communicable diseases; “Kuwaitis went from what used to be live surgery and relevant debates. Some of the topics covered will be: Hygiene and Tropical Medicine, mainly obesity, diabetes, and an extremely different lifestyle of highly using data from the World Health hypertension. This has happened intensive physical labor, like pearl div- n Surgery for type 2 diabetes. “Only 12 percent of Kuwaitis Organization, Kuwait is the due to the sudden increase in ing, to reaping the benefits of the new n Mal-absorptive operations; are they have a BMI below 25… Kuwait is suitable for our region. second-most obese nation in the socio- economical status which found natural resource – oil in the late the second-most obese nation n Current trend of bariatric surgery in world, behind the US, creating the led to population growth, drastic 1930s,” said Dr Salman Al Sabah. the Gulf region. need for bariatric surgery. changes in food consumption He explained that this dramatic in the world, behind the US, As waistlines in Kuwait and patterns quality and quantity, a change in lifestyle provides the gateway n Sleeve gastrectomy; why is it this has created the need for becoming so common? across the Gulf have expanded decrease in the physical activities for a change in both physical activity as over the last three or four years, brought on by prosperity, and the well as dietary changes. Calories con- n Management of Sleeve gastrectomy bariatric surgery.” complications. so too has the business of bariatric trend of overconsumption and sumed started exceeding calories burnt, Dr Salman Al Sabah AUD I surgery. Ten years ago there were over indulgence in every aspect leading to theSpresent increase of obesity n Revisional bariatric surgery. n Complications of bariatric surgery. only few bariatric surgeons in of life. in Kuwait. A R A B I A Kuwait, he explained. Today, there Nutritional transition is due Traditional foods have been replaced n Gastric plication and Mini gastric bypass update. are 35 surgeons involved in bariatric Institute in Kuwait is the first research- to a change in the socio-economic by energy-dense high-fat foods. Excesprocedures (private and governmental based organization that addresses standard. The process known as “nutri- sive dietary intake and unbalanced n Adolescent bariatric surgery. hospitals) and this number will increase. diabetes from a multi-disciplinary tion transition” is a global phenomenon diets along with sedentary lifestyles n Multidisciplinary session. At least 6,000 people in Kuwait approach with education, treatment of affecting population diet and physical have contributed to the increase in the “As well as surgeons, we will welcome underwent bariatric surgery last year patients, and health care professionals activity patterns in developing countries prevalence of over nutrition and the health professionals of all disciplines (Table 1), and a paper published in on a national level. incidence of diet related non- and policy makers, who I am sure will “There are some initiaObesity Surgery (2013) reported that communicable diseases such benefit greatly from this meeting. Our “We encourage more surgeons and vision is for this annual event to be the country has the highest numbers of tives to raise awareness as diabetes. operations performed as a percentage of about diabetes and obesity,” With regards to childhood the main bariatric surgery event in the health professionals to join the GOSS he added. “These are geared national population (Table 2). obesity, Dr Salman Al Sabah Gulf region. The meeting will rotate and develop opportunities for career The rise in bariatric procedures in not towards educating people said that education is the annually between the six Gulf countries; development, interpersonal networking, just limited to Kuwait; the whole region on healthy eating and exerfoundation that can reverse next meeting will be in Dubai in 2014,” he concluded. “We encourage more is facing a dramatic rise in the number of cise. However, we still need this trend. involve our residents and fellows in operations. Since 2012, over 25,000 bar- more.” “It should start with surgeons and health professionals to join various committees and educational Dr Salman Al Sabah exiatric procedures have been performed pregnant women, education the GOSS and develop opportunities plained that the rise of obein the Gulf (Table 3). at school level that promotes for career development, interpersonal programmes and extend our reach sity and diabetes are multihealthy eating and physical networking, involve our residents and internationally.” Diabetes factorial, including the fact activity, and national aware- fellows in various committees and In addition to a rise in obesity, Kuwait that some 60-80% of genetic ness of obesity. Patients in educational programs and extend our Dr Salman Al Sabah (and the wider region) has also seen a factors predispose people of Kuwait with Type II diabetes research internationally.” rise in the numbers of diabetics. Accord- middle-eastern descent to are much younger compare To find out more about the meeting, please ing to the International Diabetes Federa- both obesity and diabetes. However, he with characteristic nutritional outcomes. to patients around the world.” tion, Kuwait ranks 9th in the world for also stated that lifestyle plays a big role In Kuwait, the discovery of oil opened The biggest challenge, according to visit: gulfobesity.com prevalence of diabetes (Table 4). in the prevalence of obesity. the gates to a new era, which impacted Dr Salman Al Sabah, will be addressing Table 4 the ratio of obese and morbidly obese Table 3: The growth of bariatric procedures in the Gulf region 2007-12 (data from industry) Table 1: Number of bariatric surgery individuals to the number of qualified Adult Population (20-79) 2293.74 procedures in Kuwait 2007-12 in 1000s surgeons. He said that policies need to Year Band Sleeve Total be established on a national and regional Diabetes cases (20-79) in 407.53 1000s 2007 295 234 529 level that fits the culture and the epi17.77 Diabetes National Prevademic of obesity in the region. There is a 2008 332 426 758 lence (%) need for collaboration and support from 2009 317 670 987 Diabetes Comparative 23.09 other health care disciplines to tackle the 2010 187 1481 1668 Prevalence(%) problem of ‘diabesity’ in the region. 2011 119 4570 4689 2012 131 6551 6682 Table 2: Numbers of operations performed as a percentage of national population 2011 High Frequent (%) Low frequent (%) Kuwait 0.1642 Japan 0.0001 Sweden 0.0899 Ukraine 0.0003 Belgium 0.0772 India 0.0004 IFSO worldwide survey of 42 countries First Gulf Obesity Surgery Society Meeting “In December 2013, we will be hosting the First Gulf Obesity Surgery Society Meeting, and this will be an excellent opportunity for the gulf surgeons, health professionals, and industry to meet, collaborate, and share their experience as well as discussing with international experts,” said Dr Salman Al Sabah. “We have put together a great programme Diabetes related Deaths 1122 Incidence Type 1 diabetes (0-14) per 100,000 22.3 Mean diabetes related expenditure per person with diabetes (USD) 1886 IGT cases (20-79) in 1000s 357.86 IGT National Prevalence (%) 15.60 IGT Comparative Prevalence (%) 17.88 bariatricnews.net 7 ISSUE 18 | DECEMBER 2013 SM-BOSS study: sleeve has fewer complications than bypass T ailored approach allows the bariatric surgeon to take into account the patients’ preoperative risk profile and will optimise the longterm results of bariatric surgery The early results from the Swiss Multicentre Bypass or Sleeve Study (SMBOSS) have shown that laparoscopic sleeve gastrectomy was associated with shorter operation time and a trend toward fewer complications than with laparoscopic Roux-en-Y gastric bypass (LRYGB), however, the difference was not statistically significant. The outcomes were published in the journal Annals of Surgery (Early Results of the Swiss Multicentre Bypass or Sleeve Study (SM-BOSS): A Prospective Randomized Trial Comparing Laparoscopic Sleeve Gastrectomy and Roux-en-Y Gastric Bypass. 2013:258(5):690-5). Importantly, both procedures were almost equally efficient regarding weight loss, improvement of comorbidities, and quality of life one year after surgery. However, the study authors from Claraspital, Basel, Inselspital, Bern, Kantonsspital St Gallen, St Gallen, and University Hospital Zürich, Zurich, Switzerland, added that the long-term follow-up data are needed to confirm the results The researchers write that they undertook the randomised clinical trial to assess the effectiveness and safety of the two procedures as ‘prospective data comparing both procedures are rare’. Indeed, they note that there have been three (two from the same institution) randomised clinical trials published comparing LSG and LRYGB with small patient numbers (16–30per group) and limited follow-up (12–35 months). Study A total of 217patients were randomised at four bariatric centres in Switzerland. One hundred seven patients underwent LSG using a 35-F bougie with suturing of the stapler line, and 110 patients underwent LRYGB with a 150cm antecolic alimentary and a 50cm biliopancreatic limb. The mean body mass index of all patients was 44±11.1, the mean age was 43 ± 5.3 years, and 72% were female. The groups were similar in terms of body mass index, age, sex, comorbidities, and eating behaviour. In addition, there were no significant differences with regards to comorbidities (diabetes, hypertension, dyslipidema etc) between the two procedural groups. The primary end point of the study was weight loss, which was defined by excessive BMI loss (EBMIL), over a period of five years. To detect a 10% difference, we calculated a study size of 200 patients to reach a 94% power. Secondary end points were the rate of perioperative morbidity and mortality, the remission rates of the associated comorbidities, and the change in quality of life (QOL) in the two patient groups. Outcomes All patients presented for follow-up at 12 months, 112 patients completed followup at two years and 70 patients the threeyear follow-up at the time of analysis (median follow-up of two years). Figure 2: Reduction in comorbidity one year after surgery. No significant difference in cure or improvement of comorbidities between LSG and LRYGB except for GERD (*P = 0.008). GERD indicates gastro oesophageal reflux disease; OSAS, obstructive sleep apnea syndrome; T2DM, type 2 diabetes. The mean operative time was less for LSG than for LRYGB (87±52.3 minutes vs 108±42.3 minutes; p=0.003). Complications (<30 days) occurred more often in LRYGB than in LSG (17.2%vs 8.4%; p=0.067), although the difference in severe complications did not reach statistical significance. The rate of severe complications requiring a reoperation was 4.5% (5/110) in the LRYGB group versus 0.9% (1/107) in the LSG group (P = 0.21). The reason for the reoperation in the LSG group was obstruction of the gastric sleeve. The reasons for the five revisions in the LRYGB group were as follows: one leakage at the gastrojejunostomy, one obstruction of the biliopancreatic limb, two intraabdominal abscesses, and one pleural empyema. Except for gastroesophageal reflux disease (GERD), which showed a higher resolution rate after LRYGB, the comorbidities and quality of life were significantly improved after both procedures. Excessive body mass index loss at one year was similar between the two groups (72.3%±22% for LSG and 76.6%±21% for LRYGB; p=0.2). There was no difference regarding weight loss or EBMIL between the 2 groups after one year (Figures 1A, B), and there was no further weight loss in patients who completed the follow-up at two and three years. Comorbidities The rate of comorbidities improved in both groups (Figure 2). Except for the remission of GERD, there was no difference between the LSG group and the LRYGB group regarding the remission Figure 1: A, Change in BMI (means ± standard error). B, EBMIL (means). of comorbidities or improvement rate. Patients undergoing LSG experienced a slightly higher rate of new-onset GERD (12.5% vs 4%; p=0.12), and among those who already presented with GERD before the operation, the rate of improvement was significantly lower than those who underwent LRYGB (50% vs 75%; p=0.008). Patients from both groups experienced a significant improvement in quality of life, compared with baseline (p<0.0001) and even exceeded that of healthy individuals who reach a score of 121 points (p<0.01). In the LRYGB group, there was one anastomotic ulcer at the gastroenterContinued on page 27 8 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 with Mervyn Deitel ff o ee time C Bariatric News was delighted to speak with Professor Mervyn Deitel, one of the Founders of the American Society for Bariatric Surgery in 1983 in Iowa City and a President of the ASBS in 1995. He was one of the 13 Founders of the International Federation for the Surgery of Obesity (IFSO) in Stockholm in 1995, the first Executive Director of IFSO, and remains an Honorary Life Member. We spoke about his career in bariatric surgery…… Did you always want a career in medicine? sufficient weight and is a healthy adult today. Because I was treating starvation cases, When I was really young I want to be an in 1969 I started getting referrals of patients artist, then a scientist, and later specifically who were the opposite – massively obese with a doctor. I had two older cousins who were severe co-morbidities. doctors and I admired what they did and A urologist referred a female patient to me aspired to be like them. who had breakdowns of repairs for urinary incontinence. She weighed over 400lbs, and Why did you decide to specialise in I performed a jejunoileal bypass and she bariatric surgery, what attracted you subsequently lost a lot of weight. From then to the specialty? on, everyone started sending me their morbidly When I graduated from medical school, I obese patients. wanted to become a surgeon. I trained in New At first, the Chief of Staff at St Joseph’s York in GI and Head & Neck surgery, and in Hospital wanted to stop me performing Buffalo in cancer surgery, and then Dallas where jejunoileal bypasses; however, he soon saw the I performed trauma surgery. When I came back benefits of the major weight loss and referred to Toronto, the Chief of Surgery wanted me to his godmother to me for obesity surgery. handle shock cases such as haemorrhagic and The jejunoileal bypass got some bad press. septic shock in the Trauma Unit. I soon realised I thought it was a good operation if the patient that one of the major problems with patients was followed closely, and its main failing was was malnutrition, so in the 1960s for the first the development of renal stones years later in time in Canada, I started a treatment called about 10% of patients. intravenous hyperalimentation – which became Can you tell us how bariatric known as total parenteral nutrition. surgery has evolved during your As nobody in Canada had done this before, career? the treatment was met with some scepticism. After the jejunoileal bypass, we started We were putting in central lines for long periods performing the loop horizontal gastric bypass, of time with very high concentrations of amino originated by Ed Mason. However, this acids and sugar. Over time, I developed my operation often resulted in tremendous tension own pump, and eventually we started infusing on the jejunal loop, and if the anastomosis ever lipid emulsion, and later we wrote the original leaked, the leak would probably prove fatal for paper on liposyn concentrations (Wong KH, the patient due to the egress of large quantities Deitel M. Studies with a safflower oil emulsion of bile, pancreatic and gastric juices. So the in total parenteral nutrition. Can Med Assoc J. Roux-en Y gastric bypass was performed: a 1981;125:1328-34). jejunal Roux-loop was brought up to the high GI fistulas were referred to me, and I found that by providing nutrition centrally, the leakage gastric pouch so tension on the anastomosis was avoided. The RYGB provides a degree would immediately decrease, patients would of restriction and malabsorption, and remains gain weight, and survive. widely performed. I once treated a 500g premature newborn – Subsequently, various types of horizontal the baby was so small that the nurse’s wedding gastroplasties were tried: patients would lose ring would fit on the baby’s arm. I had to use weight for the first two years, but unfortunately the internal jugular vein which was the size of the proximal gastric pouch and outlet would a hair, and thread down a catheter. Within a expand, leading to regain weight. month, the baby could eat on his own, gained Then, in 1982, Mason reported his results from vertical banded gastroplasty (VBG), and this operation became widely adopted. The weight loss was terrific for three years, but patients then regained weight, usually because the pouch enlarged or the patients adapted their eating habits. The popularity of the VBG, which was a procedure of choice for 10-15 years, declined. Interestingly, the published VBG results were excellent, but the devil was in the details as noone could publish the results of patients lost to follow-up. Many patients were too embarrassed to return for follow-up because of weight regain. Meanwhile, laparoscopic surgery took off and gastric banding entered the arena. There is plenty of talk about band failure, but if you watch the patient and achieve regular followup, the inflatable band has been effective. In fact, I know of many bariatric surgeons who themselves opted to have a band placed in them, and not one has had it removed. The sleeve gastrectomy is on the rise, partly because it saves the US$3,000-$4,000 cost of the band. The sleeve costs the price of staples. We are also seeing the rise of gastric plication, which further saves cost, as sutures are used instead of staplers. With regards to the sleeve, my prognostication is that many patients will slowly start to regain weight around years four and five, and will eventually require a further procedure. The sleeve may really be a VBG without the band, and we may be witness to a sleeve gastrectomy hoax. I have reservations as to the accuracy of the data reported. If you look at the data closely, you will see that very many patients are lost to follow-up. I hear sleeve surgeons discussing leaks (which are infrequent but serious) and talking about drainage, stents, TPN, jejunostomy tubes, etc. But they do not seem to mention that these patients may be going through “hell”: they have drains and tubes coming out of the abdomen and may experience pain for months, and are having multiple endoscopic procedures. You founded the journal Obesity Surgery. What do you remember about its creation? In 1990, a number of bariatric surgeons felt the need for a specialized journal on obesity surgery; many articles had been refused by the general surgical journals because of insufficient interest by their readers. But, there was also opposition from a number of members of the Handbook of Obesity Surgery Current concepts and therapy of morbid obesity and related disease Editors: Mervyn Deitel, Michel Gagner, John B. Dixon, Jacques Himpens, Atul K. Madan More than 250 expert contributing authors • 480 pages • Up-to-date and comprehensive Highlights include: Surgical techniques, treatment of complications, outcomes n Gastric Banding, Band Adjustments and Strategies n Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) – Methods, Complications, Results n Complications of Gastric Bypass Other operations, techniques and stategies Respiratory and Cardiac Considerations Metabolic Considerations Preventive Strategies Psychological Considerations Other Features of Obesity and Bariatric Surgery Bariatric Practice For more information please visit: www.HandBookofObesitySurgery.com Cost in Canada and USA only $30.00 Outside Canada and USA $38.00 (includes airmail) ASBS who felt that such a journal would be unscientific and non-academic. With difficulty, I found a start-up publisher in Oxford, England, who undertook Obesity Surgery, with me as Editor-in Chief in 1991. After some difficulties, I finally took over the publishing, including the editing, design, printing, subscriptions, mailing and advertising. The journal rose rapidly, as bariatric surgery became recognized as life-saving for individuals with refractory severe obesity. Obesity Surgery attained an Impact Ranking of 7th out of 149 surgical journals for 3 consecutive years, and in 2006 Springer Science took over as publisher. Do you think the future for bariatric and metabolic surgery will be in refining current techniques or developing newer technologies? There will likely be many adaptations on top of the gastric sleeve operation. I believe that there will be salvage of restriction in many cases by applying a silastic ring. Furthermore, various malabsorptive techniques will likely be added to the gastric sleeve. The duodenal switch is a proven excellent operation. I also believe that the mini-gastric (one-anastomosis) bypass of Rutledge and its modifications will become mainstream, with an understanding of the malabsorption and its surveillance. Surgeons are now starting to realize that the MGB is a rather rapid, safe and effective operation, which can be modified with the patient’s BMI, and does not have an increased threat of cancer as some had postulated. Endoscopic techniques will also become widely used for restriction as the technologies develop. They may be limited in what they can achieve long-term, as the stomach attempts to re-expand. Endoscopic techniques will be especially used in revisional surgery. Away from surgery, how do you relax? The world continues to develop major problems. My wife and I avidly keep up-to-date with world events by watching RT America, Euro-News, Al Jazeera, BBC World, etc. (the mainstream media tends to have their own agenda). I like to garden. We love to spend time with our five grandchildren, and our two sons, one a spinal surgeon and the other a radiologist. bariatricnews.net 9 ISSUE 18 | DECEMBER 2013 Photo: Courtesy The Hebrew University of Jerusalem MetaboShield: no absorption or intestine damage The natural C-shape anatomy of this region helps keep the sleeve in place R esearchers at the Hebrew University (HU) of Jerusalem’s Biodesign programme have developed the MetaboShield, a new type of endoscopic gastric sleeve. The device, designed to prevent the absorption of excess food in the intestine and thus fight obesity, requires no general anaesthesia or incisions, and results in no tissue damage. The natural C-shape anatomy of this region helps keep the sleeve in place, blocking food absorption without damaging the intestine. “The mechanical prototype that does not move from place despite the peristalsis (movement) in the intestine,” said Dr Yaakov Nahmias, director of the HU Center for Bioengineering. “The group proved its principle that it does not shift out of place but does block the region of the gastroenterological system that allows the absorption of excess food. We haven’t decided yet what type of plastic would be used to make it, but scientists know enough today about what can be utilised without causing rejection or other problems when left permanently inside the body.” New type of gastric sleeve to block food absorption and fight obesity. The group believes that this new endoscopic procedure would appeal to millions of obese individuals who are worried about the complication of current gastric bypass procedures. “This is a huge untapped market,” said Yair Timna, an MBA student leading the project’s business development. The MetaboShield is understood to have attracted interest from Boston Scientific, although Nahmias conceded that the device is some years away from general use. Other students in the group include Dr Elad Spitzer, an orthopaedic surgeon in Hadassah Medical Center, Gabi Menagen, an MBA student, and Esther Feldblum, an engineering student Biodesign is a multi-disciplinary, team-based approach to medical innovation, created by the HU and Hadassah in partnership with Stanford University. Biliopancreatic diversion/duodenal beats bypass Study reports biliopancreatic diversion/duodenal switch improves comorbidities, compared with bypass Biliopancreatic diversion/ duodenal switch results in higher earlier reoperation rates B iliopancreatic diversion/ duodenal switch results in greater weight loss in superobese patients (BMI>50) compared with gastric bypass and control of co-existing illnesses, a study published in the Archives of Surgery (Analysis of obesity-related outcomes and bariatric failure rates with the duodenal switch vs gastric bypass for morbid obesity. 2012:147(9):847-54) has reported. However, Dr Daniel W Nelson and colleagues from the Madigan Army Medical Center, Fort Lewis, Washington, also reported that the biliopancreatic diversion/duodenal switch procedure may be associated with higher early risks compared with gastric bypass. “Although the duodenal switch carries a higher relative risk profile than gastric bypass, the absolute risk is low,” the authors report. “Among morbidly obese patients, the duodenal switch results in superior sustained weight reduction and improved comorbidity control compared with gastric bypass, which may outweigh early perioperative risk. The benefits of the duodenal switch, including a significant decrease in the bariatric failure rates, appear to be greatest in the super-obese population.” Despite the Roux-en-Y gastric bypass being widely acknowledged as the gold standard bariatric procedure, the authors note that there is some evidence that weight loss failure and weight regain following a bypass procedure may be more prevalent than first thought, especially among the super-obese. Therefore, they decided to compare the outcomes of a large cohort undergoing biliopancreatic diversion/duodenal switch against those undergoing gastric bypass, using data from the Bariatric Outcomes Longitudinal Database (BOLD). They compared 1,545 patients who underwent biliopancreatic diversion/ duodenal switch (average preoperative BMI 52), with 77,406 patients who underwent gastric bypass (average preoperative BMI 48) between 2007 and 2010. The average age of the patients was 45 years and 78% of the patients were female. The main outcome measures were weight loss; control of comorbidities including diabetes mellitus, hypertension and sleep apnoea; and failure to achieve at least 50% excess body weight loss. Results The outcomes revealed that biliopancreatic diversion/duodenal switch was as- in the biliopancreatic diversion/duodenal switch group (3.3% vs. 1.5%). However, the percentage of change in BMI was significantly greater in the biliopancreatic diversion/duodenal switch group at all follow-up intervals (p<0.05). In the super-obese population, biliopancreatic diversion/duodenal was also associated with a significantly greater percentage of excess body weight loss at two years, compared with bypass (79% vs. 67%, p<0.01). In addition, comorbidity control of diabetes, hypertension, and sleep apnoea were all superior in biliopancreatic diversion/duodenal switch patients (all p<0.05). The results also indicate that nearly 20% of bypass patients failed to lose at least 50% of their excess BMI by both the one- and two-year follow-ups, compared with weight loss failure rates of 9% and 6% for biliopancreatic diversion/duodenal patients. “In regard to postoperative comorbidity control, the biliopancreatic diversion/duodenal switch group saw significantly greater resolution or improvement in most of the wellrecognised obesity-related comorbidities, including diabetes, hypertension, hyperlipidemia and obstructive sleep apnoea,” the authors reported. Although the researchers note a relative increase in the use of the biliopancreatic diversion/duodenal switch in the US, gastric bypass is more commonly performed. They suggest that is likely due to several factors, including the technical difficulty of the procedure, the higher reported rates of short-term complications and concerns about the longer-term nutritional consequences of a primarily malabsorptive procedure. Duodenal switch “Further studies of this procedure to determine the optimal patient selection, sociated with longer operative times (191 operative technique and longer-term vs. 114 minutes), greater estimated blood risks vs. outcomes are warranted,” the loss and longer hospital stays (2.4 vs. 4.4 authors concluded. days), compared with bypass (all p<0.05). Commenting in an invited critique, Early reoperation rates were also higher ”Time for a Change in Gastric Bypass?”, (Archives of surgery.2012;147(9):854-5) Dr Alec C Beekley, Thomas Jefferson University Hospitals, Philadelphia, wrote: “Their findings and conclusions challenge the notion that gastric bypass is the optimal operation for the majority of patients. As more surgeons familiarise themselves with the operative techniques and follow-up requirements for biliopancreatic diversion/duodenal switch patients, it may be used more frequently in the super-obese population.” “Although the duodenal switch carries a higher relative risk profile than gastric bypass, the absolute risk is low. Among morbidly obese patients, the duodenal switch results in superior sustained weight reduction and improved comorbidity control compared with gastric bypass, which may outweigh early perioperative risk. The benefits of the duodenal switch, including a significant decrease in the bariatric failure rates, appear to be greatest in the super-obese population.” 10 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 Bypass surgery changes how the brain responds to food Study could explain why bypass patients lose more weight over the long term than banding patients R esearchers from MRC Clinical Sciences Centre at Imperial College London, UK have added further evidence to the theory that gastric bypass surgery changes how the brain responds to food, reducing not only hunger but also the drive to eat for pleasure, a study has found. The research, {{Obese patients after gastric bypass surgery have lower brain-hedonic responses to food than after gastric banding.||published in the journal Gut}}, helps to explain why gastric bypass patients lose more weight over the long term than those who undergo a gastric band operation. “It is well established that patients after gastric bypass lose more weight than after gastric band and we think this is because of the different physical changes made to the gut during surgery, which somehow have an effect on the drive to eat for pleasure,” said Dr Tony Goldstone from the MRC Clinical Sciences Centre who led the study. “These findings emphasise that different bariatric procedures work in different ways to influence eating behaviour. This may have important implications for the way we treat patients with obesity and could help pave the way for a more personalised approach when deciding on the choice of bariatric procedure by taking the impact on food preferences and cravings into account.” Previous studies in animals and humans have shown that those who undergo a gastric bypass tend to shift away from eating highfat and sweet foods. However the effect of different types of weight loss surgery on the brain that may be responsible for changes in food preference has not been explored until now. This may have important implications for the way obese patients are treated and could help pave the way for a more personalised approach when deciding on the choice of bariatric procedure. “Humans don’t just eat when they’re hungry – the pleasure and rewarding feelings we get from eating play a huge role in determining what kind of foods we eat, as well as how much,” said Professor David Lomas, Chair of the MRC’s Population and Systems Medicine Board, Figure 1: Whole brain comparison of activation to high-calorie foods between obese patients after gastric bypass and gastric banding. Whole brain group level comparison for high-calorie versus object picture contrast to demonstrate clusters in which blood oxygen level-dependent (BOLD) signal was lower in patients after gastric bypass (RYGB) compared with gastric banding (BAND) surgery, adjusting for age, gender and body mass index. No clusters showed greater activation in RYGB than BAND groups. Colour bar indicates Z values. Cluster activation thresholded at Z>2.1, familywise error p<0.05, overlaid onto the average T1 scan for all subjects (n=20 per group). Co-ordinates given in standard Montreal Neurological Institute (MNI) space. ACC: anterior cingulate cortex, Amy: amygdala, Caud: caudate, NAcc: nucleus accumbens, Hipp: hippocampus, MFG: middle frontal gyrus, OFC: orbitofrontal cortex, Put: putamen. Voxel-wise differences in BOLD activation between groups did not survive false discovery rate p<0.05 correction. which funded the research. “This work adds to a growing body of evidence supporting the role of the gut-brain interplay in controlling our eating behaviour. Being able to influence this relationship may in future play an important role in the development of non-surgical treatments for obesity.” Using magnetic resonance imaging (fMRI), which measures brain activity by detecting changes in blood oxygen levels and flow, the researchers studied 83 participants who had lost weight from either a gastric bypass (n=30) or gastric band surgery (n=28) carried out on average eight to nine months previously, as well as a control group of unoperated participants (n=25). These three groups were of similar body weight. They found marked differences in the brain’s response to food in patients after gastric bypass, compared to gastric band surgery. Patients who had gastric bypass had less activity in the brain’s reward regions when shown pictures of food compared with those who had gastric banding. Patients after gastric bypass also rated high-calorie foods as less appealing to look at and less pleasant to eat, had healthier eating habits and ate less fat in their diet than patients after gastric banding or the unoperated control group. Both the gastric bypass and banding patients had similarly reduced hunger compared with the unoperated group, and the findings were not explained by differences in psychological traits between the surgical groups. The researchers did not find conclusive evidence of what caused these changes, but they did observe several differences in the patients’ metabolism that could play a role. Levels of gut hormones called GLP-1 and PYY that make us feel full after a meal were higher in the gastric bypass group, as were levels of bile salts, which play a role in digestion. Patients after gastric bypass also reported more intestinal discomfort and nausea after eating foods high in fat and sugar in the early months after the surgery than patients after banding, which may also be influencing what foods they want to eat. “The identification of these differences in food hedonic responses as a result of altered gut anatomy/physiology provides a novel explanation for the more favourable long-term weight loss seen after RYGB than after BAND surgery, highlighting the importance of the gut–brain axis in the control of reward-based eating behaviour,” the paper concludes. Further work by the researchers will focus on which of these factors may be influencing the brain’s response to food following bypass surgery. This research was supported by the Medical Research Council, Wellcome Trust, National Institute for Health Research, and Imperial College Healthcare Charity. Study to assess whether low calorie diet can reverse T2DM Study will recruit 140 type 2 diabetes patients who will consume 800 calories each day for eight to 20 weeks U K researchers will soon begin a study to examine whether a 800 calorie a day diet can reverse type 2 diabetes. The £2.4 million project, supported by Diabetes UK, will be conducted by scientists at Newcastle University and the University of Glasgow and involve 140 type 2 diabetes patients. They will consume only 800 calories each day for eight to 20 weeks. Approximately 3.8 million people in Britain have diabetes, with type 2 making up around 90% of cases. The figure includes about 850,000 individuals who have type 2 diabetes but are unaware. Seven million more Britons are at particular risk of developing the disease. A previous study carried out at Newcastle University discovered a diet of 600 calories per day could put an end to type 2 diabetes in individuals new to the disease. The low calorie diet was found to decrease fat levels in the pancreas and liver, thus boosting insulin production. Only four of the 11 participants still had diabetes three months on Diabetes UK will now conduct a more thorough study with a greater follow up period that will delve deeper into the long term effects of low calorie diets. “Type 2 diabetes will always be a serious health condition but perhaps it won’t always be seen as a condition that people have to manage for the rest of their lives and that worsens inevitably over time,” said Diabetes UK head of research, Dr Matthew Hobbs. “The 2011 study and evidence from bariatric surgery has shown us that it can be put into remission. If we can do this safely, on a bigger scale and as part of routine care, then following a low calorie liquid diet would be a real game changer in terms of reducing people’s risk of devastating health complications such as amputation and blindness.” In the new study, study participants will predominantly drink nutritionally complete liquid formula shakes. They will be taught how to alter their lifestyles for good as normal meals are phased back in. The findings will be put alongside the results of 120 individuals following current slimming recommendations across a two year follow up period. Some of the participants will have MRI scans that will allow researchers to understand what is going on as the diet influences the body. “We are exploring uncharted territory and along the way there will be challenges, details to unravel, and other questions to ask,” said Professor Roy Taylor, lead researcher at Newcastle University. “But I believe this study will lead to a quantum leap forward in our understanding of how best to manage type 2 diabetes.” bariatricnews.net 11 ISSUE 18 | DECEMBER 2013 The double balloon design also allows for a greater ‘fill volume’ Company to submit a PMA to the FDA in 2014 and anticipates a launch in 2015 R eShape Medical has announced that its REDUCE Trial for the ReShape Duo Intragastric Balloon, has met its primary efficacy endpoints. The trial, which reached full enrolment in less than six months, involved eight US sites and studied 326 patients. The company is the first medical device company to successfully meet its primary efficacy endpoints in a US, randomised, shamcontrolled pivotal trial for weight loss. “Meeting the primary endpoints is an important accomplishment, as it convincingly demonstrates the superiority of the ReShape procedure over diet and exercise alone,” said Dr Jaime Ponce, Dalton, Georgia, Principal Investigator in the REDUCE trial. “The ReShape procedure offers a new alternative to help patients kick-start weight loss and learn new behaviours. We are excited about what this new treatment option may do for millions of people needing to lose excess weight.” The ReShape Duo dual-intragastric balloon is endoscopically placed down the esophagus and into the stomach, with a procedure that does not require any incisions, sutures or fixation to the body. The balloons are inflated with saline and take up much of the stomach’s volume, causing patients to eat smaller portions and to feel full sooner. The device does not change or alter the patient’s anatomy and is fully reversible. During the 24 week treatment period, patients work with dieticians, doctors and nurses to learn healthy diet and exercise habits to help them during and beyond the treatment period. ReShape Duo design “There are other technologies that involve a single balloon, however the ReShape Duo design has two discreet balloons,” added Ponce. “The double balloon design also allows for a greater ‘fill volume’ but conforms to the stomach’s natural curvature to improve comfort, without excessively distending the stomach wall.” He explained that there is a risk with single balloons deflating and migrating Duo Intragastric Balloon meets primary efficacy endpoints into the intestines, potentially causing blockages. The ReShape Duo’s double balloons are filled with saline and a blue indicator dye. If one balloon deflates, the patient will notice blue urine but Richard Thompson there is another balloon still inflated that prevents migration into the intestines. The ReShape Duo is the only intragastric balloon that has an anti-migration feature. Prior to insertion of the device, an endoscopic examination of the stomach is performed to ensure that there are no anatomical contraindications to placement of the device. The ReShape Duo would not be placed if this examination identified the presence of a large hiatal hernia, significant gastritis, an ulcer or a tumour. of patients who received the balloon and the group of patients who did not receive the balloon. “I’m encouraged about what ReShape Duo may do for millions REDUCE Trial There were two primary efficacy endpoints: n comparison of percent excess weight loss between treatment and control groups and; n percent excess weight loss responder rate in the treatment group The first endpoint measured the percent of excess weight loss between the group Bariatricnews.net News. Conference reports. Features. Opinion. Our website, updated daily. Over 12,500 visitors in November 2013. Jamie Ponce of people who need to lose excess weight,” said Ponce. “The ReShape Duo is designed to initiate and maintain significant weight loss, without the invasiveness of surgery or potential side effects of medication. It is used in conjunction with a comprehensive lifestyle modification patient program to foster long-term success.” “While the intragastric balloon is in place, patients are counselled by healthcare professionals on nutrition, exercise and behaviour change to help them connect the value of eating small portions with long-term weight control,” he added. “This programme continues following removal of the balloon to encourage new habits – and lasting results.” Intragastric balloons Modern intragastric balloons, used over the last 10 years, outside of the US, have proven to be effective with thousands of patients studied and reported in medical literature. Intragastric balloons have been available in Europe for a decade, and there is no question that they are effective in achieving significant weight loss. “Being the first device company to meet its primary efficacy endpoints in a randomised obesity trial is an important step forward on the path to FDA approval,” said President and CEO of ReShape Medical, Richard Thompson. “We saw very significant interest in participation in this study, and are looking forward to bringing the first, non-surgical weight-loss device to the US market, where ReShape Duo has the potential to help patients lose significantly more weight than diet and exercise programmes alone.” He explained that there are currently no non-surgical options available to patients in this market and the company believes the ReShape procedure will be the first, non-surgical, weight loss device commercialised in the US market. “Overall feedback from both the US and European clinical work we have done suggests that clinicians find the device is safe and easy to insert and remove,” said Thompson. “There is minimal training required for those familiar with endoscopy and the procedure can be done consistently in less than 20 minutes.” ReShape Medical plans to submit a Premarket Approval application to the FDA in the second quarter of 2014 and anticipates a launch in mid-to-late 2015. The device has been available in the European Union since December 2011. 12 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 USGI to launch ESSENTIAL endoscopic incisionless trial European outcomes from the POSE procedure show excess weight loss of 62% and total body weight loss of 19% U SGI Medical has obtained conditional approval of its investigational device exemption (IDE) application from the FDA to launch what the company believes to be the largest multicentre, randomised, sham-controlled study of an endoscopic procedure for weight loss ever conducted. The company plans to enrol approximately 350 subjects at up to nine centres across the US in the ESSENTIAL trial. “Although published data show significantly superior weight loss results from bariatric surgery than from diet and exercise alone, a major open or laparoscopic operation still poses risks and longer recovery times, and surgery is not right for every patient,” said Dr Thomas E Lavin, founder of The Surgical Specialists of Louisiana and an investigator in the trial. “Surgery for weight loss has been studied with positive results, but this will be one of the first major trials to prospectively compare the effectiveness of an endoscopic procedure against a sham procedure plus diet and exercise. Physicians participating in the study will use USGI Medical’s g-Cath EZ Suture Anchor Delivery Catheter to place tissue anchors across folds of tissue in strategically-located parts of the stomach to reduce its size and ability to stretch to accommodate a meal. The company claims that the g-Cath, which is used extensively for general, non-obesity indications, is the first endoscopic suturing technology proven to create a durable, healed fold in the stomach. “Based on preliminary studies conducted in Europe, we believe that this new approach may help patients feel full sooner during meals, improving satiety and reducing hunger cravings so they can control their portions, consume fewer calories and lose weight,” Lavin added. The incisionless outpatient procedure has been performed on over 2,000 patients, mostly in Europe, where it is known as Primary Obesity Surgery Endolumenal (POSE) procedure. The procedure is performed entirely through the mouth without any incisions through the abdomen. Many patients have returned to work without any bandages or signs of surgery within two to three days. “If the data are positive and consistent with smaller trials, it could mean that tens of thousands of patients may have an incredibly compelling option to consider if they’ve struggled to lose weight with diet and exercise, but aren’t prepared to accept the risk of traditional bariatric surgery,” said Lavin. “The start of the ESSENTIAL Trial represents a significant milestone for USGI Medical and endoscopic approaches to weight loss,” said John Cox, Chief Operating Officer of USGI Medical. “Our efforts to support this study underscore our excitement about the potential of our technology and our commitment to patient safety and outcomes. We look forward to working with many of the country’s leading bariatric surgeons and advanced endoscopists, both at top academic medical institutions and wellrespected private centres, to enrol patients in this study. Based on our experience to date, we believe our new incisionless approach to treating obesity may offer promise to patients who have struggled The POSE procedure places tissue anchors across folds of tissue in strategically-located parts of the stomach to reduce its size and ability to stretch to accommodate a meal to lose weight through diet and exercise.” European POSE results At the recent 18th World Congress of International Federation for the Surgery of obesity & Metabolic Disorders (IFSO) in Istanbul, investiagtors from Spain reported results of two studies showing the positive outcomes and physiological effects of the POSE procedure. Dr Román Turró, from the GI Endoscopy Department at the Centro Medico Teknon, Barcelona, reported the results of his team’s POSE experience from 137 consecutive procedures performed from February 2011 to July 2013. The average age of patients included in the safety analysis was 42.8 years and the average BMI 36.9 at the time of the procedure. Females accounted for 74% of the patients. The first 22 patients who had been followed for 12 months post-procedure at the time of the presentation achieved average excess weight loss of 62% and total body weight loss of 19%. Initial safety data were favourable with no reported instances of hospitalisation with a surgical intervention following the POSE procedure. One patient developed an infection that was treated with antibiotics and two patients suffered intra-gastric bleeding, which was treated endoscopically. Endoscopies on a subset of these patients also confirmed that the suture anchors remained in place in the stomach 12 months after the procedure. Also at IFSO, Dr Silvia Delgado-Aros, a member of the Neuro-Enteric Translational Science (NETS) Research Group at the Institut Hospital del Mar d’Investigacions Mèdiques in Barcelona, presented physiologic findings showing that POSE led to weight loss, a sustained reduction in caloric intake, normalisation of blood sugar levels and improved feelings of fullness and satiety triggered by an improved gut peptide response to food. In this controlled study, patients followed for 15 months reported mean excess weight loss of 63.7%. A NEW range of vitamins and minerals for your bariatric patients n Designed by Dr David Ashton, Medical Director, Healthier Weight n UK formulated and manufactured n Rigorously tested for purity and stability n Numerous advantages over competitor products t is widely accepted that lifelong multivitamin and mineral supplementation is essential for patients both before and after weight-loss surgery1. There is currently no UK manufactured bariatric product which complies with expert recommendations on post-operative micronutrient supplementation. Forceval® is a vitamin and mineral supplement commonly prescribed for surgical weight-loss patients in the UK and other European countries. However, Forceval® was never specifically formulated for bariatric patients and is deficient in a number of important respects. The concentrations of some essential vitamins and minerals are inadequate for the surgical weight loss patient, whilst other important micronutrients are missing altogether (see comparison link below). Likewise, over-thecounter vitamins and minerals from high street pharmacies fall well short of the needs of patients undergoing weight-loss surgery. It was to fill this obvious need that VitaWeight™ was developed. VitaWeight™ delivers optimal micronutrient support for bariatric patients, in a simple dosing regimen and is fully compliant with expert recommendations for post-operative supplementation2. I Advantages of VitaWeight™ VitaWeight™ products are rigorously tested for purity and stability and have a number of important advantages for the surgical weight loss patient. n Concentrated B Vitamins. The multivitamin contains all eight of the required B vitamins; Thiamin (B1), Riboflavin (B2), Niacin (B3), Pantothenic Acid (B5), Pyridoxine (B6), Biotin (B7), Folic Acid (B9) and Cyanocobalamin (B12). All eight B vitamins work together in various combinations to help the body metabolize food, protect the heart, regulate nerve growth and boost the immune system. Note: the high concentration of crystalline B12 in VitaWeight™ removes the need for B12 injections in RYGBP and other patients. n Calcium citrate. Most standard multivitamin formulations use calcium carbonate, which needs to combine with hydrochloric acid in the stomach to be absorbed. Following weight loss surgery, however, the amount of acid in the stomach is decreased and patients are often prescribed medication (e.g. PPIs) to reduce stomach acid secretion even further. For this reason we have use the citrate salt which is well digested and absorbed, even when stomach acid is decreased. n Trace elements. Our multivitamin preparation includes comprehensive trace element support, including zinc, selenium, copper, molybdenum and chromium. n Iron. Our iron source is ferrous bisglycinate. This is important because the bisglycinate salt is less irritating to the gastric mucosa and therefore has significantly fewer side effects such as nausea, epigastric pain and vomiting39. In addition, we have a significantly higher dose of iron in accordance with ASMBS recommendations (18-27mg/day). n Vitamin D. With regard to Vitamin D, Vitaweight has the D3 (cholecalciferol) form rather than the D2 (ergocalciferoal). This is because vitamin D2 has a much lower potency and a shorter duration of action when compared with vitamin D3. In fact, vitamin D2 has a potency less than one-third that of vitamin D3. n Vitamin K2. Vitaweight™ contains both Vitamin K1 and K2, which have distinct functions. Vitamin K1 is involved in blood coagulation, whereas K2 helps to direct calcium into bone and blood, rather than arteries, muscle or other soft tissues. Studies now indicate that vitamin K2 also works to prevent certain cancers and bone loss. There are several active forms of vitamin K2: MK4, MK7, MK8 and MK9. The most relevant to health is the MK-7 form which is the form included in the Vitaweight™ formula. Procedure Multivitamins and Minerals (Tablets/day) Calcium (Tablets/day) Gastric Band 1 1 Sleeve gastrectomy 1 3 Roux-en-Y gastric bypass 2 4 Recommended Dosage The micronutrient needs of patients post-operatively will depend primarily upon the type of procedure performed. The table below provides general dosage guidelines, though results from blood measurements may require a modified daily regimen. References 1.Pournaras DJ, le Roux CW. After bariatric surgery, what vitamins should be measured and what supplements should be given? Clin Endocrinol (Oxf) 2009; 71:322-5. 2.Aills L, Blankenship J, Buffington C et al. Bariatric Nutrition: Suggestions for the Surgical Weight Loss Patient. ASMBS Allied Health Sciences Section Ad Hoc Nutrition Committee. Surg Obes Relat Dis. 2008;4(5 Suppl):S73-108. How to prescribe A comparison between VitaWeight™ and Forceval® together with detailed product information, scientific references and information leaflets are available at: http://vitaweight. co.uk/medicalprofessionals Special January 2014 Offer If you or your patients would like to purchase directly go to http://vitaweight.co.uk/buy-now and enter the code Barinews20 for a 20% discount or call Chrissie Twigg on Freephone 0800 073 1146 bariatricnews.net 13 ISSUE 18 | DECEMBER 2013 Mini-Gastric Bypass, 2nd International Consensus Conference, Paris. October 9 2013 Mini-gastric (one-anastomosis) bypass becoming a mainstream bariatric operation Professor Mervyn Deitel Chief, Advisory Board, International Bariatric Club, Editorin-Chief Emeritus & Founding Editor of Obesity Surgery T he mini-gastric one-anastomosis bypass (MGB) was conceived by Dr. Robert Rutledge in USA 16 years ago, as a safe, rapid and effective bariatric operation. The MGB has slowly gained proponents throughout the world, particularly increasing in the past 5 years. In October 2012, an international MGB Conference of 55 experts was held in Paris, under the leadership of Drs. Rutledge and Jean-Marc Chevallier (President of the French bariatric society – SOFCO). Because of international requests, a second MGB Conference was held in Paris in October 2013, with 35 MGB surgeons from 13 countries, many at the professorial level. The Chair of the 2013 Conference was Prof. Pradeep Chowbey, immediate Past-President of the International Federation for the Surgery of Obesity; many see Prof. Chowbey as the Father of both laparoscopic and bariatric surgery in India, where the MGB is being rapidly adopted following the excellent results reported by Kular and others. The MGB Consensus attendees all reported end-to-side to the jejunum. In the presence of a hiatal hernia, no effort is made to address this at the time of MGB. Experience has shown that MGB is very effective in resolving GE reflux disease (GERD). This is thought to be related to traction which the GJ anastomosis provides on the gastric pouch, which reduces the cardia within the abdomen, plus resolution of the patient’s obesity. We thus have a gastric conduit and a fat/carbohydrate malabsorptive procedure. The pouch in the MGB shows little dilation because there is no outlet narrowing by a stoma or pylorus. Modifications of the Technique Some (but not all) MGB surgeons vary the length of the bypass. In super-obese (or very tall) patients, the GJ is performed >250cm distal to Treitz’ ligament. Tacchino’s group from Italy has performed more than 600 MGBs; Mervyn Deitel Figure 1. Diagrammatic representation of the MGB of Rutledge. (Amended for Bariatric News by Peter Williams) earlier SG revisions to MGB). Presenters repeatedly emphasized the need for a long gastric pouch. Pradeep Chowbey Robert Rutledge prior experience with other bariatric operations – Roux-en-Y gastric bypass (RYGB), gastric banding (GB) and sleeve gastrectomy (SG). Greco reported that recently they have modified the MGB by leaving a larger gastric pouch and constructing the GJ 300cm proximal to the ileocecal valve (i.e. leaving a 300-cm common channel). Most of the surgeons agreed that the GJ must be placed at least 200-300cm proximal to the ileocecal valve, to maintain adequate nutrition. Flores from Mexico presented the Spanish technique of Profs. Caballero and Carbajo, where an antireflux valve is constructed on the afferent side of the GJ; sutures are placed between the sleeve and afferent limb to inhibit reflux. Survey of the attendees revealed that >80% use the Rutledge method and measurements, 10% the Carbajo antireflux method, and 5% the Tacchino 300-cm common limb. If ever necessary, the MGB can be modified for inadequate or excess weight loss by moving the anastomosis distally or proximally as a brief, simple procedure. Bhanderi of India constructs a longer sleeve, almost to pylorus. Prasad of India performs the MGB using robotics. The MGB is now being performed for weight regain after the SG operation. All the experts emphasized that it is very important not to construct a short gastric pouch for the MGB. The MGB pouch is the opposite of the small proximal pouch constructed in the RYGB. A small, short gastric pouch in the MGB would recreate the physiology of the old Mason loop gastric bypass and could lead to bile reflux (as was done with some of Weiner’s Technique The laparoscopic operation (Figure 1) creates two components: first, a restrictive lesser-curvature gastric pouch; second, a 200cm or longer jejunal bypass with a single antecolic gastro-jejunostomy (GJ) anastomosis, which leads to significant fat malabsorption. Creation of the Gastric Pouch The lesser curvature of the stomach is identified at the junction of the body and antrum. The stomach is initially stapler-divided at a right-angle to the lesser curvature, distal to the incisura (distal to the crow’s foot). A 28–40 Fr bougie is passed by the anaesthetist, and the stomach is stapler-divided upwards parallel to the lesser curvature. With approach to the gastro-esophageal (GE) junction, the surgeon divides the stomach lateral to the angle of His; the cardia in the MGB is explicitly avoided and not dissected (unlike in the SG operation). Creation of the 200cm malabsorptive jejunal bypass Attention is turned to the left gutter, and the omentum is retracted medially to identify the ligament of Treitz. The bowel is run to ~200cm distal to Treitz’ ligament. At this site, the distal tip of the gastric sleeve is anastomosed antecolic Survey Findings and Discussion A SurveyMonkey questionnaire had been carefully answered pre-Conference and was discussed. This is a largely academic surgical group who carefully records their data, because the MGB was met with some skepticism. The Survey identified a total of 16,651 MGBs performed by the attendees. Average preoperative BMI was 46.1 ±4.1 (SD) (range 38-62). Mean operating time was 80.3 ±24.9 minutes (range 38-130). Average hospital stay was 3.2 ±1.6 days (range 1.1-6.0), and became less as the surgeon performed more MGBs. Leaks were reported in 0.03% (five patients), which are less than the dreaded proximal leaks following the SG operation. During surgery, the use of the methylene blue or air test decreased with experience. The use of a drain also decreased with experience. Patients were usually ambulatory a few hours after surgery. Diabetes had resolved at one year in 91.4 ±4.9% (range 82–96). Persistent resolution of co-morbidities and improvement in quality of life were reported by Peraglie based on a personal experience with 1,400 MGBs, Hargroder with 1,100 MGBs, Cady with 2,500 MGBs, Chevallier with 888 MGBs, Kular with 1,200 MGBs, Musella with 1,000 MGBs, Tacchino with 600 MGBs and W.J. Lee with >1,000 MGBs. Preoperative GE reflux was found in 15.3 ±14.2%, and postoperatively in 4.7 ±14.2%. The experts’ opinion was that GERD improves after MGB. Revisional surgery has become necessary in 3.2% (0.4% for bile reflux). It was very rare that a Braun entero-enterostomy became necessary. Marginal ulcers have occurred in 1.4 ±1.8% (range 0-5), which is less than after RYGB. Interestingly, Spain and India have found almost no postoperative ulcer occurrence. The %EWL was: one year 75.8, two years 85.0, three years 78.0, four years 75.0, five years 70.2, longer 70.0. Failure to lose >50% of excess weight at five years occurred in 14.2 ±25.1%. Operative 30day mortality has been very low – 0.2% (33 deaths). In the consensus survey, bowel obstruction was very rare and had occurred in 0.15 ±0.36% (range 0–1), and none was due to an internal hernia. There has been no intractable hypoglycemia. Regarding marginal ulcer development, the MGB should not be performed in smokers, those taking salicylates, and many felt it should not be used in those taking heavy alcohol. However, Kular in India noted that patients in his area of India tend to take whisky, without problems. However, as with the RYGB, there is more rapid absorption of alcohol, which should thus be decreased. Most of the surgeons prescribed a PPI, and all ordered supplements (multivitamins, calcium – preferably dairy, yoghurt, and Proferrin® as an iron supplement. In 5% of menstruating women, iron deficiency develops, and may require I.V. iron. The majority treat H. pylori preoperatively, and many treat it if it becomes necessary postoperatively. No case of carcinoma has been found in the gastric pouch or esophagus after MGB. Some critics have referred to a rat study where concentrated bile in the stomach led to cancer; however, J.D. Frantz in 1991 showed that bile led to hyperplasia and malignancy in the proximal 2/3 of the unique rodent stomach (which is squamous cell) and not in the glandular distal 1/3 (which corresponds to the human stomach). Wei-Jei Lee of Taiwan described his 10-year comparison of MGB and RYGB, where long-term weight loss, resolution of diabetes and elevation of GLP-1 were slightly better after the simpler and safer MGB. Conclusion There was early prejudice against the MGB by surgeons who performed a longer, more difficult procedure. However, the numerous surgeons throughout the world who perform the MGB reported essentially the same results. The attendees have found the MGB to be a rapid, technically simple, safe, effective operation with an absence of leaks, a single antecolic large anastomosis in easy view, the bypassed length modifiable with the degree of BMI, durable weight loss, easily revisable by moving the anastomosis, and if ever necessary, reversable. Bibliography Rutledge R, Walsh TR. Continued excellent results with the mini-gastric bypass: six-year study in 2,410 patients. Obes Surg 2005;15:1304-8. Noun R, Skaff J, Riachi E et al. One thousand consecutive mini-gastric bypass: short- and long-term outcome. Obes Surg 2012;22:697-703. Lee WJ, Yu PJ, Wang W et al. Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial. Ann Surg 2005;242:20-8. Carbajo M, Garcia-Caballero M, Toledano M et al. One-anastomosis gastric bypass by laparoscopy: results in first 209 patients. Obes Surg 2005;15:398-404. Lee WJ, Wang W, Lee YC et al. Laparoscopic mini-gastric bypass: experience with tailored bypass limb according to body weight. Obes Surg 2008;18:294-9. Frantz JD, Bretton G, Cartwright ME, et al. Proliferative lesions of the nonglandular and glandular stomach of rats. In: Guides for Toxicologic Pathology STP/ARP/AFIP, Washington, DC, 1991. Peraglie C. Laparoscopic minigastric bypass (LMGB) in the super- super obese: outcomes in 16 patients. Obes Surg 2008;18:1126-9. Chevallier J-M, Chakhtoura G, Zinzindohoue F. Laparoscopic mini-gastric bypass. In: Deitel M, Gagner M, Dixon JB, Himpens J, eds. Handbook of Obesity Surgery. 2010:pp78-84. www.HandbookofObesitySurgery. com Lee WJ, Ser KH, Lee YC et al. Laparoscopic Roux-en-Y vs. mini-gastric bypass for the treatment of morbid obesity: a 10-year experience. Obes Surg 2012;22:1827-34. Musella M, Susa A, Greco F et al. The laparoscopic min-gastric bypass: the Italian experience: outcome from 974 consecutive cases in a multicenter review. Surg Endosc 2013 Aug 28 [Epub ahead of print]. 14 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 An update from the MARS initiative I n 2007, Ethicon began the Metabolic Applied Research Strategy (MARS) initiative, a multi-year, multi-million dollar commitment to support fundamental research into obesity and other metabolic disorders. Now in its sixth year, Bariatric News talks to Dr Elliott Fegelman, Medical Director at Ethicon, about the benefits the MARS programme is bringing to surgeons and patients around the world… “The MARS initiative was started because while we could see excellent results bariatric and metabolic surgeons were obtaining but as a community, we couldn’t really explain why,” began Fegelman. “As a result, Ethicon established a partnership with surgeons to give them the opportunities to provide some answers and to look for less invasive methods of achieving the same results.” As part of the initiative, the company started to support the work of two research laboratories: the Metabolic Diseases Institute (MDI) at the University of Cincinnati, and the Obesity, Metabolic & Nutrition Institute (OMNI) at the Massachusetts General Hospital (MGH). These two institutions had the capbility to perform basic and translational research, and were committed to understanding the physiological changes that can occur after bariatric and metabolic surgery. In essence, these two centres were charged with helping to deconstruct, understand and reinvent bariatric procedures in ways that improved outcomes, focusing on fundamental research around obesity and metabolic disorders. Research The research undertaken at MGH is led by Dr. Lee Kaplan, Associate Professor of Medicine at Harvard Medical School, Director of the Obesity, Metabolism, and Nutrition Institute, and Director of the Weight Center at MGH. Dr. Kaplan’s extensive research is focused on the physiological and molecular mechanisms of gastrointestinal regulation of energy balance and metabolic function. His group has pioneered the development and use of rodent models for weight loss surgery and gastrointestinal devices to explore these mechanisms. Dr. Randy Seeley, Professor of Medicine at the University of Cincinnati College of Medicine, Director of the Cincinnati Diabetes and Obesity Center, and Director of the Obesity Research Center, is leading the work on the actions of various peripheral hormones in the central nervous system that serve to regulate food intake, body weight and the levels of circulating fuels. These two centres have performed the majority of the efforts concentrating on the basic science level, which includes understanding surgical procedures’ mechanisms of action at the tissue, cellular, molecular and genetic levels. Understanding “The MARS initiative has been responsible for some of the most seminal work published on the mechanisms of action, microbiota and metabolic signalling, and this work continues to be built upon,” said Fegelman. “In a broader sense, what MARS has really allowed us to understand is that the gastro-intestinal tract is a hugely complex sensory organ with complex signalling mechanisms.” “When we think about the GI tract in those terms, the techniques and procedures become less important and the effects on the sensory organ become paramount, and this is the focus of many current investigations,” he continued. “It has been known for years that the gut and the brain communicated, what has changed recently is that we have begun to understand what those signalling mechanisms look like, what parts of the brain respond to these signals and how the GI tract adapts.” pany is also supporting other specialties. As part of the MARS initiative, in 2010, the company donated U.S. $500,000 in funding to support up to three, three-year research grants through the American Diabetes Association. The research grants support the investigation of the specific mechanistic effects of bariatric surgery on diabetes. They also support translational research to improve the clinical understanding of various bariatric procedures as potential treatment options for people with obesity and Type 2 diabetes mellitus. This is a further example of how metabolic disease is not limited to just one medical specialty or field and therefore requires a multidisciplinary approach to discover new ways to combat the disease. “The MARS Scientific Advisory Board (SAB) changes every year as they try to bring new people on board and identify new ways of looking at the data and patient experience. The constantly evolving Advisory Board is based on the questions we are asking or being asked and the expertise we are looking for,” said Fegelman. “It is primarily surgeons at this point, mostly because this is the group that we have the most experience of working with and because they have the greatest experience of bariatric and metabolic surgery.” “However, as we move forward I am sure that the SAB will continue to evolve and will include diabetologists and endocrinologists, nutritionists and bariatric physicians, as the gulf in dialogue between the surgical and medical viewpoints regarding this patient population narrows.” Elliott Fegelman Lee Kaplan Randy Seeley Such has been the rate of discovery that the MARS initiative has achieved to date: it’s been responsible for more than 65 publications, including 14 peer-reviewed articles, which have been published across the whole spectrum of the medical field, underlining the multifaceted aspects of metabolic disease. Patient benefits Not only has the MARS initiative brought new insights into our understanding of how bariatric and metabolic surgical procedures work, but it has made a significant difference in the real world – to patients. “Patients have benefitted by an increased knowledge of how effective a procedure will be for them. For example, we can now inform patients about how a bypass will benefit them more than a band,” Fegelman explained. “We can discuss the rationale of the procedure and explain how GLP-1, insulin sensitivity etc., will impact the outcome of surgery. “From personal experience, I explain to patients how a procedure changes their physiology; I can see that patients are much more confident in the procedure. Bariatric surgeons are no longer just performing surgical procedures; through dedicated research, such as the MARS Initiative, they are now in a position to inform as well as operate.” Multi-disciplinary Ethicon is not only working with bariatric and metabolic surgeons to discover new and valuable insights into metabolic disease, the com- The future “I don’t think we are too far away from providing a solid economic argument for bariatric and metabolic surgery. If we can identify the optimum time to treat a patient so the disease-costs are significantly reduced by surgical intervention, that is an investment I believe society will pay.” “I believe the ‘holy grail’ would be to find some insulin-like treatment that we could give to the patient subcutaneously that would mimic hormonal signalling or a drug that functions as the serotonin uptake inhibitors do to treat depression; that affects the signalling mechanism at the hypothalamus. As a result, surgery would only be considered in the most critical or an emergent case, similar to how cardiac surgery is performed today. “Let’s not forget, this is a super complex system with multiple inputs and responses, and the body has evolved highly-developed defences against manipulation. So whether we get there in a decade or longer I really couldn’t say,” Fegelman concluded. “What I can say is that working with Drs. Kaplan and Seeley on the MARS initiative has provided incremental changes in our knowledge and understanding, and that any future developments will come about by an evolutionary rather than revolutionary process.” For more information regarding the MARS Initiative, please visit: http://www.ethicon.com/mars-education To educate others on the critical findings of the principal researchers of the MARS initiative, Ethicon has hosted 11 MARS Outreach Courses since late 2011. Due to the overwhelming interest in the information, 12 additional global courses are planned for early 2014. Contact your local Ethicon representative if you are interested in attending a MARS Outreach Course. Increased risk of premature birth after surgery No differences in still birth or neonatal death rates between sugical and non-surgical patients These pregnancies should be considered risk pregnancies and that prenatal care should monitor them extra carefully W omen who have bariatric surgery and then fall pregnant are more likely to give birth prematurely and to babies who are small for their gestational age, according to a large registry study carried out at Karolinska Institutet in Sweden and published in the BMJ (Stephansson et al. Perinatal outcomes after bariatric surgery: nationwide population based matched cohort study. 2013). The researchers believe that these pregnancies should be considered risk pregnancies and that prenatal care should monitor them extra carefully. “Mothers with the same BMI gave birth to babies of varying weights depending on whether or not they had undergone bariatric surgery, so there is some kind of association between the two,” said Dr Olof Stephansson, obstetrician and Associate Professor at the Clinical Epidemiology Unit at Karolinska Institutet. “The mechanism behind how surgery influences foetal growth we don’t yet know, but we do know that people who have bariatric surgery are at increased risk of micronutrient deficiencies.” However, the researchers noted that bariatric surgery has numerous benefits for mothers, such as lowering the risk of diabetes, cardiovascular disease, cancer and stroke, and untreated obesity is a known risk factor for both mother and baby during pregnancy and childbirth. The study is the most extensive ever performed in the field, was based on data from the Swedish Medical Birth Register and the Patient Register, and compared 2,562 babies born between 1992 and 2009 of women who had previously undergone bariatric surgery with 12,500 babies born to mothers who had not. The pregnancies were matched individually, so that the mothers’ BMI, age, educational background, smoking habits, and previous births were comparable in both groups. The main outcome measures were preterm birth (<37 weeks), small for gestational age birth, large for gestational age birth, stillbirth (≥28 weeks), and neonatal death (0-27 days). Results Preterm birth was observed in 9.7% (243/2511) of post-surgery births versus 6.1% (750/12 379) in matched controls (risk difference 3.6%, 95% confidence interval 2.4% to 4.9%; p<0.001). The risks were increased for both medically indicated and spontaneous preterm births. The risks of moderately and very preterm birth were also higher in postsurgery births than in control births. The risk of delivering a small for gestational age infant was higher in women with a history of bariatric surgery than in matched controls (5.2% (131/2507) v 3.0% (369/12 338); risk difference 2.2%, 95% confidence interval 1.3% to 3.2%; p<0.001). Although, the opposite was the case for large for gestational age births. The researchers reported that the procedure type or interval between surgery and delivery did not impact whether the baby was preterm or small for gestational age birth. There were no differences between post-bariatric surgery and matched control births were detected for stillbirth (0.79% (20/2534) v 0.60% (75/12 468); risk difference 0.19%, 95% confidence interval −0.18% to 0.56%; p=0.32) or neonatal death (0.28% (7/2514) v 0.26% (32/12 393); risk difference 0.02%, −0.20% to 0.24%; p=0.86). The researchers said that women with bariatric surgery history should be considered a risk group when pregnant and should n Receive particularly close prenatal attention nHave extra ultrasound to check fetal growth n Given special dietary supplement recommendations. “This nationwide matched cohort study found an increased risk of preterm and small for gestational age births but lower risk of large for gestational age births in women with a registered history of bariatric surgery compared with women with similar characteristics but without a history of bariatric surgery,” the authors write. “This could not be attributed to differences in maternal age, parity, early pregnancy body mass index, smoking, or educational level, which were used as matching factors. Data suggested that the increased risks of preterm and small for gestational age births were confined to the comparison of women with an early pregnancy body mass index <35.” “Our study did not investigate whether the increased risk for small for gestational age birth was caused by micronutrient deficiencies, nor if it can be reduced by more intensive micronutrient or foetal growth monitoring” they conclude. “The mechanism behind the observed effect modification by BMI also needs further exploration, as no excess risks were observed for preterm or for small for gestational age birth in women who were morbidly obese.” bariatricnews.net 15 ISSUE 18 | DECEMBER 2013 Bariatrics+ app now free App provides the information ‘at their fingertips’ U K bariatric specialists have developed the Bariatrics+ app to help manage bariatric patients in the emergency setting. The unique app provides background information on morbid obesity, surgery and other treatments and how to manage early and late complications. Managing a morbidly obese patient who presents as an emergency can be daunting for doctors unfamiliar with bariatric surgery. Even when patients have lost weight, there are particular complications that need to be considered and the changes in anatomy as a result of previous surgery can be confusing. As a result, many bariatric patients experience a delay in appropriate management, or in some cases, are managed incorrectly. Ms Sally Norton, consultant bariatric surgeon and British Obesity and Metabolic Surgery Society (BOMSS) council member, has developed a free iPhone app to help address this problem and improve patient safety. “Trainees and consultants will increasingly be faced with managing emergencies in this challenging group of patients – this app provides all the information they need at their fingertips,” she said. Photos, illustrations and radiological images help the user understand the operations and implants that patients may have had or complications that may have occurred. Links to medical or industry websites provide extra information as needed. The app has the support of BOMSS. In addition, generous industry support from Medical Innovation Development (MID), Covidien, Ethicon Endosurgery and Bariatric Solutions has enabled the app to be made available for free download via the iTunes store. “I am very grateful to Covidien, Ethicon Endosurgery, MID and Bariatric Solutions for their generous sponsorship which has enabled free downloads world-wide. I hope to find additional sponsors to enable me to build the same app for other phone platforms and to translate to other languages.” The app, which was launched at the recent AUGIS meeting, is endorsed by BOMSS and Sally Norton will be seeking IFSO endorsement. She will be publishing the results of the surveys into the usefulness of the app in due course Key features of the app include: n Morbid Obesity – background to the epidemic, definition, associated problems and treatment options. n Bariatric Operations – understand about common and not-so-common operations and procedures to treat morbid obesity – as well as the indications for revisional surgery. n Emergencies – basic principles for treating any morbidly obese patient, explanation of symptoms and complications associated with weight loss surgery, appropriate investigations and urgent treatment options – including how to deflate a gastric band. n Images – gallery of photographs, X-rays and operative images that may be invaluable in managing bariatric emergencies, video link to demonstration of gastric band deflation. n More – useful links to educational and industry websites where further information can be found. If you would like to provide suggestions for improvement or would like to sponsor this patient safety and medical education initiative to allow translation into other languages and expansion to other mobile platforms, please contact Ms Sally Norton via BOMSS: [email protected] BOMSS unveils new Fellowship Curriculum for UK surgeons Updated Fellowship Curriculum aimed at enhancing the delivery of metabolic surgery T he British Obesity and Metabolic Surgery Society (BOMSS) has issued an updated Fellowship Curriculum aimed at enhancing the delivery of metabolic surgery. Bariatric Fellows work at centres in North Tyneside, Sunderland, Luton and Dunstable, Imperial, UCH and Taunton and are supported by an unconditional grant from an industrial partner for professional development of a metabolic surgery service and intended to be applicable to other Royal College of Surgeons (RCS) -approved Fellowships as and when approved. Richard Welbourn, President of BOMSS Six new Fellows will start work at the centres in October and will use the new curriculum. The fellowships are RCSEng approved in high volume centres providing specialist bariatric services. “I’m delighted to announce that education and Training experts at BOMSS have worked hard to produce a comprehensive curriculum which offers world-class Fellowships at UK centres,” said Mr Richard Welbourn, President of BOMSS. The Fellowship curriculum covers a wide range of technical skills and professional attributes including: n Managing patients who are morbidly obese and understanding their surgical treatment, including early and late complications n Understanding different patterns of presentations of complications n Experience in Gastric Bypass and at least one other bariatric procedure nProducing work of scientific value in the field of bariatric and metabolic surgery n Teaching junior medical staff and allied healthcare professionals. The updated curriculum can be viewed on the BOMSS website: www.bomss.org.uk/trainees.htm 16 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 Canadian study Bariatric surgery can be performed safely in secondary health care centres Overall mortality and centrespecific mortality are well within accepted values L aparoscopic bariatric surgery can be performed safely in secondary health care centres with a dedicated service corridor to an affiliated tertiary health care centre, according to a study published in the {{Laparoscopic bariatric surgery can be performed safely in secondary health care centres with a dedicated service corridor to an affiliated tertiary health care centre.||Canadian Journal of Surgery}}. “With proper patient selection, a dedicated health care team and a service corridor to an affiliated tertiary health care centre, laparoscopic bariatric surgery, including gastric bypass can be performed safely in secondary health care centres,” wrote study author, Dr Nicolas Christou, Section of Bariatric Surgery, Division of General Surgery, McGill University, Montreal, Canada. “Further study is needed to determine whether the model can be applied across Canada.” As in many countries around the world, access to bariatric surgery is difficult and limited by a number of factors including insurance coverage, funding and hospital resources. In 2006, a unique pilot project was started to determine whether laparoscopic bariatric surgery can be safely performed in smaller hospitals, designated as secondary health care centres, and linked via a dedicated service corridor to a full service tertiary health care centre. The model was proposed by l’Agence d’évalu – ation des technologies et des modes d’intervention en santé (AETMIS) in a report to the Quebec Minister of Health and Social Services as a means of increasing bariatric surgery capacity in the province. The paper presents the outcomes from pilot project. The 534-bed McGill University Health Centre (MUHC), which has more than 40 years of bariatric surgery experience, is fully equipped with an intensive care unit (ICU) and has dialysis capability, Table 1: Patient stratification and complications recorded within the first 30 days after surgery at each site Group; mean ± SD or no. (%)* Factor SHCC THCC p value OS-MRS 1.6 ± 1.1 2.6 ±1.7 0.001 ASA class 2.8 ±0.8 3.2 ±0.8 0.001 Operating time in-out of room, min 89.0 ±12.0 145.0 ±23.0 0.002 Length of stay, d 1.9 ±0.1 2.8 ±0.4 0.003 Major complications 16 (2.3) 9 (5.8) 0.036 Minor complications 35 (5.2) 19 (12.3) 0.003 Readmission within 30 days of surgery 16 (2.3) 3 (1.9) 0.003 Direct transfers to THCC 7 (1.2) – – Deaths 0 2 (1.3) NS ASA = American Society of Anaesthesiologists; OS-MRS = obesity surgery mortality risk score; SHCC = secondary health care center; THCC = tertiary health care center. •Unless otherwise indicated was selected as the secondary health care centre. The tertiary health care centre was the Centre Métropolitain du chirurgie, a fully accredited 17bed private hospital with a “Specialized Medical Centre” designation from the Ministry of Health and Social Services. The study included 830 patients: 676 treated at the affiliated secondary health care centre and 154 at the affiliated tertiary health care centre. Gastric bypass was performed in 85.4% of patients, gastric band in 11.1% of patients and gastric sleeve in 3.5% of patients. BMI was significantly higher in the patients treated at the tertiary health care centre, than at the secondary health care centre (mean 54.4 vs. 47.5). The same surgeon performed all procedures with the same dedicated operating room team, ward nurses and support staff over the duration of the study. Patients with potentially life-threatening complications were transferred to the tertiary healthcare centre via a special ambulance using a priori determined protocol (service corridor). Outcomes There were significantly more women treated at secondary than tertiary health care centre, and these patients were also younger (by about one year). However, patients treated at a tertiary centre were heavier and their BMI significantly higher (p=0.001). Gastric bypass was the predominant procedure because gastric banding was not publicly funded in Quebec until recently. There were two deaths at the tertiary centre and no deaths at the secondary centre (overall mortality was 0.2%). Logistic regression analysis failed to identify any variables (age, sex, location of surgery, starting BMI, ASA score, OS-MRS) contributing to the risk of death owing to low incidence of death. Complications recorded within the first 30 days after the surgery were slightly higher at the tertiary centre and obesity surgery mortality risk scores and ASA score were also significantly higher at the tertiary centre (Table 1). The major complication rate was 2.3% (n=16) at the secondary centre and 5.8% (n=9) at the tertiary centre (p=0.036), and minor complications were significantly more frequent in the tertiary centre (p=0.003). Seven patients (1%) required direct transfer to the tertiary centre and all were treated successfully. Weight loss in kilograms and the percentage of total weight loss were equivalent between the two centres. Although a comparison of the excess weight loss between the centres regarding the surgical procedure was not possible due to insufficient data, gastric bypass was associated with significantly better weight loss results than the gastric band and gastric sleeve procedures. Whilst he acknowledges that the current study represents the personal series of one experienced bariatric surgeon, and a less experienced surgeon may not be able to duplicate these results, Christou believes that appropriate selection of a secondary health care centre and adequate training of the preoperative, perioperative and postoperative teams, remains imperative. “We have now collected sufficient statistics to suggest that, with proper patient selection, this approach could be feasible,” claims Christou. “Patient selection criteria allow for safe surgery to be delivered at secondary health care centres with acceptable mortality and short- and long-term complications. Overall mortality and centre-specific mortality are well within accepted values.” Publically-funded LAGB results in effective weight loss Results demonstrate achievable weight loss through safe and least complex obesity surgery option A dapting bariatric surgery in the Canadian public health care system has the potential to alleviate on-going health care burden from obesity-related disease, according to a study published in the Canadian Journal of Surgery (Outcomes of the adjustable gastric band in a publicly funded obesity program. 2013;56(4):233-6). The data suggest that the weight loss achieved with laparoscopic adjustable gastric banding (LAGB) in a sustainable public programme is substantial and successful, the authors note, and that the safety of the procedure was clearly demonstrated. Although they acknowledge that long term data are still required to ‘ultimately decide the true cost-effectiveness of LAGB in our system’, the study of the short-term results ‘represents a realistic view of achievable weight loss through this safe and least complex obesity surgery option’. The researchers undertook the study as there is no uniform long-term data on public bariatric surgery programmes or consensus currently on patient selection criteria for LAGB. “These controversies are reflected in that not all Canadian provinces fund LAGB as a treatment for obesity,” they note. “The publicly funded obesity treatment program at our institution is a referral-based, multidisciplinary clinic providing tertiary medical, psychological and surgical interventions.” The investigators performed a retrospective study involving patients who underwent LAGB during a six-year period from 2005 to 2010 and the shortterm weight loss results at one-, two- and three-year follow-up were analysed. They calculated the weight loss results as both percentage total body weight loss (%TBWL) and percentage excessive body weight loss (%EBWL) based on an ideal body weight generated using a normal BMI of 24.9. The analysis of complications were separated into two categories: short (postoperative period before discharge from hospital) and medium term (the period from discharge up to three-year follow-up). In addition, they also reported the operational costs for on-going LAGB care, we assessed the duration of surgery, length of stay (LOS), frequency of clinic visits and band fillings, and methods of investigation used during the follow-up period. They included two generations (Real 1 and 2) of the REALIZE adjustable gastric band (manufactured by Ethicon Endo-Surgery) and reported the differences in performance between the two devices. Outcomes They identified 178 patients who underwent LAGB during the study period: 153 women (86%) and 25 men (14%). The average age was 42.8 years, and the average preoperative BMI was 44.2 (SD -/+7). The trends of weight loss over the 3 years are illustrated in Figure 1. Three patients’ weight data were not included Figure1: Percentage total body weight loss and percentage excess body weight loss among patients who underwent laparoscopic adjustable gastric band surgery. in the weight loss analysis owing to early removal of band (n=1) and complication or pregnancy affecting weight (n=2) before one-year follow-up. The preoperative conservative weight management achieved a %TBWL average of 4.4%. The most common short-term complications were postoperative nausea (19%) and non–surgical site infections, such as pneumonia and urinary tract infections (1%). The reoperation rate was 4.5%. In an analysis of operational costs, the average duration of surgery was 56 minutes, and the average LOS was 1.4 days. Clinic visits occurred most frequently in the first year, with an average of seven visits, and dropped to four visits in the next two years. The average number of band fillings required was three fills in year one, and one fill only in the other two years. They noted that 36% of our patients required at least one investigation postoperatively. Fluoroscopy was the most common method (86%), followed by computed tomography (9%) and upper endoscopy (4%). REALIZE comparison The comparison between Real 1 and 2 gastric bands is presented in Table 1. They found significant differences in preoperative BMI, weight loss and duration of surgery. The weight loss analysis was based on one-year followup data because not enough patients who received the newer Real 2 band had complete two-year follow-up data. The weight loss achieved through LAGB in the short-term plateaued between the second and third year reaching a %TBWL of 20% and %EBWL of 44%. Regarding the comparison between the first and second generations of the REALIZE gastric band, the investigators claim the data suggest significant differences in the duration of surgery and weight loss at one-year follow-up. The surgery was three minutes longer in the newer Real 2 band group, which likely represents a small learning curve using the new product. The %EBWL was higher in the Real 1 group; however, the preoperative BMI between the 2 groups was also significantly different, with the Real 1 group having a higher BMI. “Since the 2 groups’ baseline characteristics were not identical, especially with respect to preoperative weight, it is difficult to determine whether the observed difference in %EBWL is truly significant,” the write. “More data collection with longer follow-up will be needed to further investigate the difference in weight loss observed between patients who received the different bands.” “Our patients may represent a distinct population that differs from that in the private system,” the researchers conclude. “Long-term data are necessary to determine the cost-effectiveness of this important surgical option for severe obesity.” Table 1: Comparison between the first (Real 1) and second generation (Real 2) of the REALIZE adjustable gastric band at one-year follow-up. Characteristic Real 1 No. of patients Gastric band; mean (SD)* p value Real 2 90 57 Age, yr 44.2 (10) 41.1 (9.8) 0.09 Preoperative BMI 45.7 (7.9) 41.2 (5.4) < 0.001 Operative time, min 52.1 (14) 55.1 (10) 0.013 LOS, d 1.40 (1.4) 1.20 (0.045) 0.73 Excess body weight loss, % 22.7 (20) 12.1 (14) 0.002 5.5 0 0.15 Complication, % BMI = body mass index; LOS = length of stay; SD = standard deviation. *Unless otherwise indicated. bariatricnews.net 17 ISSUE 18 | DECEMBER 2013 Clinical comment Access to surgery Nicolas Christou Professor of Surgery, McGill University, Montreal, Quebec, Canada U nder Canada’s publicly funded system, if two 40-year-old mothers, each with three children, require life-saving surgery, one a bariatric procedure for obesity and the other a mastectomy for breast cancer, it is almost always the latter who gets the surgery within a reasonable time period. The reason is that society views the obese mother as “a big fat slob who should go on a diet”. Politicians think, “Obesity is not a sexy political issue”. Policy-makers and the public don’t understand that obesity is a highly complex chronic disease, with causes rooted in a patient’s biology, metabolism and mental health. As a result, bariatric surgery is not well funded in most of Canada. Bariatric surgery is the only known treatment that will reduce the risk of dying of cancer by 60%, from a diabetes complication by 90%, or reduces total mortality risk by 40% to 60%. There’s almost nothing else we do in medicine that’s so effective and has such a dramatic impact on one’s health. Remarkably though, Canada only performs about 3,500 procedures per year in public hospitals. Private-pay clinics (mostly adjustable gastric banding) account for another 1,500 procedures per year. The country is only touching the tip of the iceberg in terms of dealing with the demand in the population. Ontario is the only province willing to make a significant attempt at addressing the country’s shortcomings in this area. In July 2008, it announced $741 million in new funding for a comprehensive, four-year diabetes strategy, of which approximately 10% was targeted toward access to bariatric services. This $75-million initiative increased the province’s capacity for weight-loss surgery several fold over the last five years to about 2,500 cases per year or 250% increase in 2012-13. The province of Quebec is unique within Canada’s healthcare system because of the Chaoulli v. Quebec (Attorney General), 2005 SCC 35, [2005] 1 SCR 791 decision by the Supreme Court of Canada which ruled that Section 15 of the Health Insurance Act and section 11 of the Hos- pital Insurance Act, which outlaw private medical insurance, violate the right to personal inviolability as guaranteed by the Quebec Charter of Human Rights and Freedoms. The decision proved to be highly contentious by its political nature and its conflict with the present government’s policy on health. There are those who argue that this decision could potentially lead to the dismantling of the Canadian Medicare system, while others suggest that this could be a much-needed wake-up call to repair the ailing system. Although in 2005 Quebec performed the most obesity surgeries in Canada, the average wait time for a procedure in the province was ~7 years. To address this, the Quebec Minister of Health convened a panel of experts to come up with a plan to increase capacity for bariatric surgery in the province and thus reduce the wait. The report tabled in 2006 recommended the creation of 4 centers of excellence in bariatric surgery that would anchor the 4 RUIS (Réseau Universitaire Intégrée Sante) or integrated health regions in the province. These centers would be located in tertiary academic hospitals that would be able to treat all bariatric surgery cases and all bariatric surgical complications irrespective of complexity. The expert panel also recommended the creation of secondary bariatric surgery centers that would perform bariatric surgery on uncomplicated bariatric surgical patients (e.g. Body Mass Index less than 50 kg/m2, minimal obesity associated comorbidity and ASA class 1-3). These secondary bariatric surgical centers would have a formal association with one of the tertiary centers within their respective RUIS for dealing with complications of bariatric surgery as well as academic and research support. In response to the Chaoulli decision, the Minister of Health also tabled a law, which created a mechanism for guaranteeing surgery within a timely fashion. If the public healthcare system could not provide the required surgery (initially for hip and knee replacements but eventually others such as bariatric surgery) within a predefined timeframe (see figure), than patients would be given the option to utilize the newly createdcmS (Centre Médicale Spécialisée) clinics. Two types ofcmS were proposed based on the funding model. Privately delivered publically funded or privately delivered privately funded. As part of this initiative a pilot project was started to determine whether acmS could carry out bariatric surgery in a safe and timely manner. The results of this pilot study show that the model works in this particularcmS and should be tested further with more secondary centers before wide application. MGB results encouraging, more evidence needed Surgery resulted in a significant and consistent reduction in BMI, glycaemia and HbA1c values The prevalence of diabetes remission was evident in both groups and increased overtime, regardless of the type D espite “encouraging” results regarding the effectiveness of mini-gastric bypass on diabetes remission, additional studies are needed to provide definitive conclusions in selecting the ideal procedure for diabetes remission before the procedure can be seen as a valuable alternative to the Roux-en-y gastric bypass, according to a study published in the World Journal of Gastroenterology (2013;19(39):6590-7). The aim of the study was to investigate the weight loss and glycaemic control status (blood glucose, haemoglobin A1c (HbA1c) and hypoglycaemic treatment), following sleeve gastrectomy (SG) or mini-gastric bypass. Data from patients referred during a three-year period (from January 2009 to December 2011) to the University of Naples “Federico II” diagnosed with obesity and diabetes were retrieved from a prospective database. A total of 53 subjects who underwent sleeve gastrectomy or minigastric bypass for obesity and diabetes were screened for the inclusion in this study. Of these, four subjects were excluded because of surgical complications, seven subjects were omitted because young surgeons conducted the operations and 11 subjects were removed because of the lack of follow-up. Thus, a total of 31 obese patients (15 males and 16 females; mean age: 38.32 ± 3.21 years; BMI: 44.78±4.25) were recruited for this study. All patients were diagnosed with type 2 diabetes [15 (48.4%) on metformin and 16 (51.6%) on metformin + insulin], 18 subjects (58.1%) reported hypertension and eight presented with hypercholesterolemia. Figure 1: Prevalence of subjects achieving diabetes remission in the sleeve gastrectomy group and mini bypass group. The mean glycaemia value was 169.87±35.76, and the mean HbA1c level was 8.5±1.0. A total of 15 subjects underwent SG (48.4%), and 16 patients underwent MGB (51.6%). The authors report that following surgical intervention, “a significant and consistent reduction in BMI, glycaemia and HbA1c values were observed relative to the baseline values”. With regards to surgery type, sleeve gastrectomy and mini-gastric were both associated with similar percent changes in BMI (-24.33 ± 4.48 vs. -24.19±4.42, p=0.931), glycaemia (-24.30 ± 11.40 vs. -28.42 ± 14.03, p=0.379) and HbA1c (-22.57±8.70 vs. -22.67±8.46, p=0.975). However, significant correlations were not detected in the percent change from baseline to 12-mo follow-up between BMI and glycaemia, as well as between BMI and HbA1c. The results were confirmed based on the type of surgery and the percent change in BMI did not correlate with changes in glycaemia (r=-0.119, p=0.673 for sleeve and r=0.462, p= 0.071 for mini bypass) or with changes in HbA1c (r=-0.349, p=0.202 for sleeve and r=-0.018, p=0.946 for mini bypass). The prevalence of diabetes remission was evident in both groups and increased overtime, regardless of the type (Figure 3). At three months post-surgical intervention, diabetes remission was reported by 18 subjects (53.3% sleeve vs. 62.5% mini bypass, p=0.722). The results were confirmed at six-months (53.3% sleeve vs. 68.8% bypass p=0.473) and 12-months (66.7% sleeve vs. 87.5% mini bypass, p=0.220). The percent change in BMI was similar between patients achieving diabetes remission and patients who did not (-24.28 ± 4.33 vs. -24.15 ± 4.53, respectively, p=0.97). However, after adjusting for various clinical and demographic characteristics in a multivariate logistic regression analysis, a high HbA1c was considered a negative predictor of diabetes remission at 12 months (OR=0.366, 95%CI: 0.152-0.884). Using the same regression model, mini bypass showed a clear trend towards a higher diabetes remission rate relative to SG (OR=3.780, 95%CI: 0.961-14.872). “Although we observed a clear trend in our study, this did not achieve statistical significance,” the authors note. “A multivariate analysis was performed to adjust for major clinical and demographic variables, but because of the relatively small sample size, our results need to be validated in larger studies. Thus, the present work could be considered a preliminary study, providing the rationale for a randomised prospective trial.” The study authors noted that the exclusion of the duodenum could suggest the potential superiority of mini-gastric bypass over sleeve gastrectomy to obtain diabetes remission and that this mechanism could suggest the potential superiority of mini-gastric bypass over sleeve gastrectomy to obtain diabetes remission. “Thus, although the gold standard for diabetes remission is still the Roux-en-y gastric bypass, being similar mechanisms of diabetes remission involved and being easier to be performed, the mini-gastric bypass could become a valuable alternative,” they conclude. 18 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 The role of a psychologically-led Tier 3 multi-disciplinary intensive weight management intervention as part of a bariatric surgery pathway Janet Biglari & Sevim Mustafa Joint Managing Directors The Bariatric Consultancy Emeritus Professor Julia Buckroyd The University of Hertfordshire Introduction here has been extensive debate as to the role and overall benefits of Tier 3 non-surgical specialist weight management services. The new clinical commissioning policy for Complex And Specialised Obesity Surgery issued in April 2013 by the NHS Commissioning Board brings this debate into even sharper focus. Guidelines state that all bariatric surgery candidates must in the first instance access local Tier 3 multi-disciplinary specialist weight management services for a period of 12 to 24 months. For patients with a BMI over 50 the minimum acceptable period is six months. This raises a question around the role and responsibilities of these services. Can they offer an alternative non-surgical pathway or is their primary function to provide multi-disciplinary preparation for surgery? As the field of obesity treatment matures, research suggests1,2 that not only is it difficult for patients to achieve a weight loss significant enough to improve their health status, but also available treatments are not supporting long-term successful weight maintenance. Bariatric surgery is largely considered to be the only effective treatment for obesity it is advocated by the National Institute of Clinical Excellence (NICE). According to Shedding The Pounds, (September 2010) compiled by the Office of Health Economics, ‘between 11,000 and 140,000 people in England currently qualify for bariatric surgery under NICE guidelines, while the actual number of surgeries that took place in England in 2009-10 was 3,607.’ It is clear that demand for bariatric surgery in the United Kingdom exceeds provision and there is a need for a more sophisticated model to manage the demand for obesity services. Bariatric surgery is often portrayed by the popular media as a ‘magic cure’ that places little responsibility for a good outcome on the recipient. However T success in bariatric surgery demands a capacity to make significant lifestyle changes and modify eating behaviour. It provides a window of opportunity of 18 to 24 months for patients to implement the changes neccessary. As with other treatments surgery is unlikely to deliver long-term weight maintenance if patients do not make fundamental changes. Whether a patient is treated in a specialist weight management service or proceeds onto a surgical pathway a growing body of evidence suggests3 that programmes combiing psychological behaviour change, dietetics and a physical activity component are the most effective model for long term weight maintenance. The Service Model The Bariatric Consultancy has been developing and delivering specialist multidisciplinary Tier 3 weight management programmes since 2008. We currently deliver two services across the South of England, offering treatment to around 600-700 patients a year. The service model is psychologically led. In March 2011 the National Obesity Observatory (NOO), published its paper Obesity and Mental Health, concluding that there are strong bi-directional associations between obesity and mental health. Research also suggests obesity is associated with high levels of childhood maltreatment,4,5 which manifest in adulthood as complex mental health problems resulting out of a history of trauma and poor attachment.6,7 These early experiences often result in disordered eating and a reliance on food for emotional regulation. It is our experience that by addressing the roots of a patients eating behaviour they are more able to understand their triggers and develop an alternative means of emotional regulation. Patients who have an intensive psychological intervention have shown high retention rates in the service and engage more extensively with the dietetic and exercise components. Our research has shown that patients who adhere to the programme will lose between 5-10% of their excess weight. Since implementing these services we have experienced a significant impact on the numbers of patients requesting surgery. In one locality over a 12 month period the number of patients opting for surgical weight loss was reduced by 70%. Tier 4 providers within the pathway have reported that patients are better informed and that only those who are medically and psychologically prepared are accessing surgical services. Our specialist weight management service fulfils the criteria set out by NICE (2006), and also the new commissioning policy (April 2013). Treatment is multidisciplinary delivered by specialist clinicians, including physicians, dietitians, psychological therapists, and exercise facilitators. The service model provides a multi-disciplinary intervention including medical management, dietetics, psychological therapy, and an exercise component. A programme of this kind identifies those who cannot commit to lifestyle changes and are unlikely to achieve a good outcome from surgery. It also identifies those whose psychological status is not sufficently robust for them to undergo surgery, along with those whose medical conditions, eating behaviour or psychological disorders suggest the need for prior treatment. Our specialist services are offered to patients with a BMI of 35≥ and are delivered locally to the patient usually in General Practices or Health Centres. Patients are also able to access our service post surgery for psychological management if they are unable to make sufficient change to support a good outcome. We have developed a four-phase treatment intervention that offers: 1. Multi-disciplinary Assessment 2. Intensive Treatment Phase (12 weeks) 3. Maintenance Phase (nine months) 4. Tier 4 Assessment and Preparation Our model is psychologically led with all patients accessing an intensive psychological therapies intervention. Clinics are spread geographically across localities and work to address any health inequalities present. Intensive Treatment Treatment is primarily delivered in a group consisting of 10-15 participants. The programme is carried out over 12 consecutive weeks and is based around Cognitive Behavioural Therapy to facillitate behaviour change. There is also an educational dietetic component, and participants are prescribed activity goals and encourgaed to engage in community based activities and home exercise. All patients receive follow up one to one sessions with the psychological therapies team and dietitians at six, nine and twelve months. Patient’s emotional well-being is monitored at the start and completion of the Intensive phase using two outcome questionnaires, Clinical Outcomes in Routine Evaluation (CORE), and The Rosenberg Self Esteem Scale.8,9 Patients that are considered not to be psychologically robust enough for the group programme, are offered a similar treatment intervention but based on one to one contacts with a psychological therapist and dietitian but still encouraged to join the group exercise programme. Maintenance Treatment Maintenance treatment takes place over a nine month period. It is patient led and incorporates regular contact with the clinical team. Patients are also invited to attend support group meetings that are led by one of the therapy team. Physiological and psychological markers along with weight and BMI are collected at six, nine and twelve months. even if their weight loss has been poor. Patients proceeding to surgery will go through a preperation process. This includes a specialist medical assessment with a Bariatric Physician and attendance at a surgical seminar which sets out to educate patients on every aspect of surgery. This will include the Tier 4 journey, and post surgical dietary behaviour and lifestyle changes. Patients are also educated on the problems associated with skin folds, and potential medical and psychological complictions. Patients are then provided with a list of approved surgical centers that are available to their area, and asked to research their preferred provider before making a final choice. Once a patient has been accepted on to a surgical pathway, they are discharged from our service. Developing close communication with surgical providers ensures that a patients progess is monitored and each patient is contacted by telephone six weeks post surgery by the patient coordinator. If a patient is found to be struggling with psychological change they can be re admitted to the Tier 3 service for a further intervention. The success of our services has been an understanding of the complex needs of this patient cohort and the requirement to tailor services directly for them. We have also been responsible for educating and training other clinicians within the obesity pathway on the management of this complex patient group. The debate around the part specialist Tier 3 weight management services have to play within a bariatric surgery pathway will continue. As yet there is no established standardised commissioning model. The services already commissioned are in their infancy and there is no long term data available to establish their efficacy in weight reduction and maintenance. However the responsibility they take for the in depth education and preparation of surgical candidates is measurable and should be evident in patients who are referred on to bariatric surgery pathways and are screened by the surgical multi-disciplinary teams. Tier 4 Assessments and Preparation Patients are not considered for onward referral to a surgical service until they have completed at least six months treatment. Bariatric surgery will only be considered for patients once the MDT have agreed that all other avenues of non surgical weight loss have been exhausted and that the patient is both medically and psychologically prepared. Patients must Multi-disciplinary Assessment also have demonstrated a commitment to This takes place in two stages. Initially the Tier 3 programme and have shown new referrals undergo a motivational the ability to address behaviour change interview carried out by a patient coordinator usually by telephone. This will 4.Sansone, R. A., Schumacher, D., References assess a patients readiness to change. PaWiderman, M.W., and Routsong1.Klem, M.L.,Wing, R.R., Lang, W., tients accepted onto the programme are Weichers, L. (2008). The prevalence McGuire, M.T., Hill, J.O. (2002) Does of childhood trauma and parental then assessed by the multi-disciplinary Weight Loss Maintenance Become caretaking quality among gastric surEasier Over Time? Obesity Reteam. Collection of baseline data such as gery candidates. The Journal of Treatsearch, 8 (6): 438-444. weight, BMI, and physiological markers, ment & Prevention, 16, 117-127. resting heart rate, blood pressure, and 2.Anderson, J.W., Grant, L., Gotthelf, L., Stifler, L. (2007). Weight loss 5.Kivimaki, M., Batty, G., Singh-Manoux, mobility assessment form part of this A., Nabi, H., Sabia, S., Tabak, A.G, et and long-term follow-up of severely process. The results of the assessments al. (2009). Association between comobese individuals treated with an mon mental disorder and obesity over determine an individual’s treatment plan. intense behavioral programme. Inthe adult life course. British Journal of ternational Journal of Obesity 31(3): Patients are also screened for medical Psychiatry, 195 (2): 149155. 488–493. problems and unresolved complex 3.Cooper, Z., and Fairburn, C.G. 6.Wilde, J.E., Kalarchain, M.A., mental health issues. This may result in Marcus, M.D., Levine, M.D., and (2001). A new cognitive behavioural a specialist referral to acute services or Courcoulas, A.P. (2008). Childhood approach to the treatment of obesiCommunity Mental Health Teams. maltreatment and psychiatric morty. Behaviour Research and Therapy, 39, 499-511. bidity in bariatric surgery candidates. GLP-1 test could predict efficacy of bypass on T2DM remission A hormone test may be able to predict the extent of metabolic improvement caused by the gastric bypass, according to the results of a rodent study by researchers from the Institute of Diabetes and Obesity (IDO), Helmholtz Zentrum München, Germany, and the University of Cincinnati, Ohio. They report that the sensitivity of the glucagon-like peptide 1(GLP-1 hormone), can predict the metabolic efficacy of a gastric bypass, and therefore could be used as a novel predictive biomarker for personalised treatment of type 2 diabetes and obesity. The results were published in the journal {{GLP-1R responsiveness predicts individual gastric bypass efficacy on glucose tolerance in rats.||Diabetes}}, “If our results are confirmed in clinical trials with patients, the hormone response could be tested before the planned surgery and surgeons would be able to predict how much an individual patient’s glucose metabolism would benefit,” said Professor Matthias Tschöp, Helmholtz Zentrum München. “This will contribute to the development of personalized therapies for type 2 diabetes and obesity. For surgical procedures such as gastric bypass this is particularly compelling because such operations are complex and cannot be easily reversed.” One hundred ninety-seven high-fat-diet-induced obese male Long-Evans rats were monitored for body weight loss during Exendin-4 (Ex4) administration. Stable populations of responders and non-responders were identified based on Ex4induced BW loss and GLP1-induced improvements in glucose tolerance. Sub-populations of Ex4 extreme responders and nonresponders received RYGB. Following RYGB, responders and non-responders showed similar BW loss compared to sham, but non-responders retained impaired glucose tolerance. “These findings present an opportunity to optimize the use of bariatric surgery based on an improved understanding of GLP-1 biology and suggest an opportunity for a more personalised therapeutic approach to the metabolic syndrome,” they conclude. “This latest study showed that GLP-1 responsiveness varied considerably with regard to glucose metabolism, and the more responsive the animals were to GLP-1, the greater the efficacy of the gastric bypass turned out to be regarding glucose metabolism improvements. Thus, the responsiveness to GLP-1 could be a key indicator for the success of the gastric bypass.” Matthias Tschöp Obesity Surgery, Springer New York, 18, 306-313. 7.Biglari, J., Buckroyd, J,. Mustafa, S,. Howlett, N. (submitted) Poor Psychological Health and a History of Abuse, in Bariatric Surgery Candidates: Levels of Pathology in the UK. 8.Rosenberg, M., (1965). Rosenberg Self Esteem Scale. 9.Barkham, M., Margison, F., Leach, C,.Lucock, M., Mellor-Clark, J., Evans, C.,Benson, L., Audin, K.& McGrath, G. (2001). Service profiling and outcomes benchmarking using CORE-OM: Toward practice-based evidence in the psychological therapies. Journal of Consulting and Clinical Psychology, 69 (2), 184-196. bariatricnews.net 19 ISSUE 18 | DECEMBER 2013 ASBP develop algorithm to guide physicians in obesity care The algorithm emphasises patients’ overall health and reducing their risk of developing obesity-linked conditions T he American Society of Bariatric Physicians (ASBP) has published an algorithm to help physicians navigate medical treatment for obesity care. Researchers have developed and written an obesity algorithm, which aims to provide all physicians with training and tools for prescribing and implementing an obesity treatment plan, tailored to each patient. The algorithm emphasises patients’ overall health and reducing their risk of developing obesity-linked conditions. Following an examination of current lifestyle and family history, a physical examination, and laboratory testing, specific changes will be recommended. These changes relate to diet and nutrition, physical activity, counselling, and medication, as appropriate. “Physicians are now confronted with the need to understand what makes obesity a disease and how patients affected by obesity are best managed,” said Deborah Bade Horn, ASBP president-elect and Algorithm Committee cochair. “They can benefit from the algorithm, which compiles the experience of researchers and clinicians who engage in obesity treatment on a day-to-day basis.” The society claims this is the first-ever comprehensive algorithm that navigates the physician’s role in medically treating and caring for patients affected by obesity. The ASBP Obesity aims to give all physicians training and tools for prescribing and implementing obesity treatment plans for patients. Among these plans, changes in nutrition, exercise and behavior are included. Physicians may also recommend weight-loss medications or discuss surgical options for excess fat reduction. “This will help give physicians a better opportunity to manage patients affected by obesity in the most compassionate, scientifically sound and cost-effective way possible,” said Dr Jennifer Seger, ASBP Trustee and Algorithm Committee Co-chair. The algorithm emphasizes patients’ overall health and reduction in risk of developing associated conditions, such as type 2 diabetes, hypertension, sleep apnea, cardiovascular disease and depression. Changes will only be recommended following an examination of the patient’s current lifestyle, family history, physical exam and laboratory testing. The algorithm will aid physicians in determining whether these results warrant a need for intervening obesity treatment and what that care would look like. The algorithm also offers suggestions for affordable treatment options. Physicians can use the algorithm to create individualised treatment plans for patients, providing them with optimal obesity care at an affordable cost. The ASBP Obesity Algorithm, a summary about how physicians can use the algorithm, the Medical Obesity Treatment Options Fact Sheet, and a patient-friendly infographic, is available as a free download from the ASBP website: www. asbp.org/obesityalgorithm 20 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 DS results in greater weight loss and improved insulin sensitivity RCTs are needed to determine whether there is a significant longterm effect of these variations C ompared to gastric bypass, duodenal switch results in greater weight loss and improves insulin sensitivity and glucose homeostasis without causing a hyperinsulinemic response, according to a study published in Surgical Endoscopy (Mitchell et al. Response to glucose tolerance testing and solid high carbohydrate challenge: comparison between Roux-en-Y gastric bypass, vertical sleeve gastrectomy, and duodenal switch. 2013). The study researchers, led by Dr Mitchell Roslin of Lenox Hill Hospital in New York, said that hyperinsulinemic hypoglycemia is common after Roux-en-Y gastric bypass (RYGB) and could be a cause in weight regain. Therefore, they decided to compare the effect of RYGB, vertical sleeve gastrectomy (VSG), and duodenal switch on insulin and glucose response to carbohydrate challenge. For this prospective nonrandomized study, they gathered data from patients that met National Institutes of Health criteria for bariatric surgery, performed via a laparoscopic technique at a single institution. Preoperatively and at six, nine and 12 months’ follow-up, patients underwent blood draw to determine levels of fasting glucose, fasting insulin, glycated hemoglobin (HbA1c), C-peptide, and two hour oral glucose challenge test. The researchers then calculated the homoeostatic model assessment (HOMA)-IR, fasting to one hour and one to two hour ratios of glucose and insulin. Outcomes Data from a total of 38 patients (13 RYGB, 12 VSG, 13 duodenal switch) were available for analysis. At baseline, all groups were similar; the only statistically significant difference was that duodenal switch patients had a higher preoperative weight and BMI. All operations caused weight loss (BMI 47.7 ± 10–30.7 ± 6.4 in RYGB; 45.7 ± 8.5–31.1 ± 5.5 in VSG; 55.9 ± 11.4–27.5 ± 5.6 in duodenal switch), reduction of fasting glucose, and improved insulin sensitivity. The results also showed that RYGB patients had a rapid rise in glucose with an accompanying rise in one hour insulin to a level that exceeded preoperative levels. This was followed by a rapid decrease in glucose level. In comparison, DS patients had a lower increase in glucose and one hour insulin, and the lowest HbA1c. These differences were statistically significant at various data points. The researchers added that for VSG, the results were intermediary: “Because the response to challenge after VSG is intermediary, pyloric preservation alone cannot account for this difference.” The wide fluctuations in glucose levels seen with gastric bypass could have an impact on hunger and weight control in the long run, the researchers concluded. They stressed that randomised controlled trials are needed in order to determine whether there is a significant long-term effect of these variations. This paper was presented at the SAGES 2013 Annual Meeting, in April 2013, in Baltimore. The study was sponsored by Covidien. Study helps to explain mechanisms of duodenal switch Results reveal that different postsurgical effects of GB vs. DS in terms of food intake, eating rate, energy expenditure and absorption D uodenal switch induces greater body weight loss by reducing food intake, increasing energy expenditure and causing malabsorption, compared to bypass that induces body weight loss by increasing energy expenditure, according to a study in rat models, Mechanistic Comparison between Gastric Bypass vs. Duodenal Switch with Sleeve Gastrectomy in Rat Models, published online in the journal Plos One. The authors state that although both gastric bypass (GB) and duodenal switch have been widely used in bariatric surgeries, the latter appears to be superior to GB in terms of weight loss. The procedures have shown different efficacy in individual patients and the underlying mechanisms are not yet clear; whether this is due to biological or behavioural factors. The aim of the study was to better understand the mechanisms leading to body weight loss by comparing these two procedures in experimental models of rats. Study GB was performed without the Roux-en-Y reconstruction and the postsurgical anatomy was similar to mini-GB on humans, and DS was performed according to the rat anatomy. Thirty-four rats, at 587.0±8.1g body weight, were randomly divided into experimental (GB and DS) as well as control groups (laparotomy, LAP): GB (14 rats), DS (7 rats), and LAP (13 rats). The body weight was not different between the groups before surgery (p=0.276). Because of markedly loss of body weight after DS, the group of DS rats, together with age-matched group of laparotomized rats (LAPDS, 7 rats), were followed up only for eight weeks, while GB rats and the rest of laparotomized rats (LAPGB, 6 rats) were followed up for 14 weeks. Outcomes LAP alone did not reduce body weight during the study period (maximum 14 weeks). GB caused approximately 20% weight loss throughout the study period (14 weeks). DS induced approximately 50% weight loss within 8 weeks. With regard to food intake (Figures 1 and 2), LAP and GB increased daytime (but not night-time) food intake (expressed as either kcal/rat or kcal/100 g body weight) at three weeks, and had no effects afterwards (14 weeks postoperatively). In contrast, DS reduced night-time (but not daytime) food intake (kcal/rat at both two and eight weeks or kcal/100g body weight at two weeks). The food intake (kcal/100 g) at eight weeks was not reduced because of markedly loss of the body weight after DS. GB increased night-time energy expenditure (kcal/hr/100g body weight) at three weeks and daytime energy expenditure at 14 weeks postoperatively (Fig 3A, C). DS increased daytime energy expenditure both at two and eight weeks as well as night-time energy expenditure at eight weeks postoperatively (Fig 3B, D). Overall, the results show that the increased energy expenditure took place only during night-time (relevant to active energy expenditure) shortly after GB (weeks) and switched to daytime (resting energy expenditure) after months, whereas the energy expenditure was increased during daytime shortly after DS and during both dayand night-time months after DS. There was no change in the faecal energy density after GB. DS had severe diarrhoea within 2 weeks postoperatively, so that it was difficult to collect the faecal samples. At two months, the solid faeces were collected and the energy density was increased (Figure 4). The researchers acknowledge that there are several limitations of the study: n The rats used were not obese and therefore it is not known whether postsurgical effects of these two procedures are different between normal and obese rats Figure 1: Total food intake (kcal/rat) (A, B) and relative food intake (kcal/100 g body weight) (C,D) during day- and night-time. Short-term after surgery: 3 weeks after gastric bypass (GB), 2 weeks after duodenal switch (DS) or 2–3 weeks after lapatoromy (LAP). Long-term after surgery: 14 weeks after GB, 8 weeks after DS or 8–14 weeks after LAP. Data are expressed as means ± SEM. *: p<0.05, **: p<0.01, ns: not significant between LAP (n=13) vs. GB (n=8) or DS (n=5). Figure 2: Eating behaviour.Satiety ratio (min/g) (A,B) and rate of eating (g/ min) (C,D) during day- and night-time. Short-term after surgery: 3 weeks after gastric bypass (GB), 2 weeks after duodenal switch (DS) or 2–3 weeks after lapatoromy (LAP). Long-term after surgery: 14 weeks after GB, 8 weeks after DS or 8–14 weeks after LAP. Data are expressed as means ± SEM. ***: p<0.001, ns: not significant between LAP (n=13) vs. GB (n=8) or DS (n=5). Figure 4: Faecal energy density. Three weeks after gastric bypass (GB) or laparotomy (LAPGB) (A) and eight weeks after duodenal switch (DS) or laparotomy (LAPDS) (B). Data are expressed as mean ± SEM. **: p<0.01, ns: not significant between LAPGB (n = 7) vs. GB (n = 8) or LAPDS (n = 6) vs. DS (n = 5). Figure 3: Energy expenditure during day- and night-time. Short-term after surgery: 3 weeks after gastric bypass (GB), 2 weeks after duodenal switch (DS) or 2–3 weeks after laparotomy (LAP). Long-term after surgery: 14 weeks after GB, 8 weeks after DS or 8–14 weeks after LAP. Data are expressed as means ± SEM. *: p<0.05, **: p<0.01, ***: p<0.001, ns: not significant between LAPGB (n=7) vs. GB (n=8) or LAPDS (n=6) vs. DS (n=5). n GB procedure used in rats was not exactly the same as it was applied in humans. n Although the size of gastric pouch after GB does not correlate with weight loss outcome in patients it cannot be excluded whether lack of the pouch in GB has impact on food intake, satiety and eating behaviour. n The differences between rats and humans are not only in terms of the GI anatomy but also the responses to surgery. For instance, sleeve gastrectomy only (without duodenal switch) works in some patients but not in rats. They added that it could be interesting to directly compare the effects of sleeve only vs. sleeve with duodenal switch (one or two-staged) in the future. Conclusion The study shows that the rat models provide results that are in accordance with results from clinical series in patients, i.e. greater weight loss by DS than GB. Furthermore, the results reveal that different postsurgical effects of GB vs. DS in terms of food intake, eating rate, energy expenditure and absorption. “Appropriately designed rat models provide significant insights into the mechanisms of bariatric surgery which explain well the clinical observations, e.g. that DS is superior to GB in body weight loss,” the authors conclude. “The results of the present study may suggest further that GB induces body weight loss by increasing energy expenditure, whereas DS induces greater body weight loss by reducing food intake, increasing energy expenditure and causing malabsorption.” bariatricnews.net 21 ISSUE 18 | DECEMBER 2013 Study defines who needs bariatric surgery most Diabetes, gender and smoking status better indicators of risk of death among obese patients M ost patients who undergo bariatric surgery are obese women, even though their male counterparts are more at risk, especially if those men are smokers and have diabetes, according to a study published in JAMA (Simple Prediction Rule for All-Cause Mortality in a Cohort Eligible for Bariatric Surgery, 2013). Not only do the findings confirm that BMI is not the best way to prioritise patients for bariatric surgery, they outline who should have greater access to surgery. “If you’re a female non-smoker without diabetes, which, incidentally, is who is being operated on in general around the world, you have the lowest risk,” said principal investigator of the study, Raj Padwal from the Faculty of Medicine & Dentistry, University of Alberta. “Bariatric surgery is most often offered to younger, female non-smokers who don’t have diabetes. “It’s simple math that will predict a patient’s risk of death. For example, if you’re a middle-aged, male smoker with diabetes, your risk of dying in ten years is ten times higher than a young, female, non-smoker who doesn’t have diabetes, irrespective of BMI.” The researchers created a simple mortality risk calculator that physicians can use to determine the risk of death in patients eligible for bariatric surgery, by inputting age, gender, smoking status and whether the patient has diabetes. Study Using current eligibility criteria for bariatric surgery such as BMI thresholds has been criti- Raj Padwal (left) and Arya Sharma cised as arbitrary and lacking evidence. The study was designed to verify the importance of BMI as a mortality predictor, as well as identify other important mortality predictors, and to construct a mortality prediction rule in a population eligible for bariatric surgery. They studied individuals from the UK General Practice Research Database, a population-representative primary care registry population-representative register who met contemporary eligibility criteria for bariatric surgery (BMI, ≥35.0 alone or 30.0-34.9 with an obesity-related comorbidity) from January 1988 to December 1998. They included 15,394 patients and used binary logistic regression to construct a parsimonious model and a clinical prediction rule for ten-year all-cause mortality. Outcomes They found that the mean (SD) age was 46.9 (11.9) years, BMI was 36.2 (5.5), and 63.2% of the patients were women. All-cause mortality was 2.1%, and mean follow-up duration was 9.9 years. The final model, which included age (odds ratio, 1.09 per year [95% CI, 1.07-1.10]), type 2 diabetes mellitus (2.25 [1.76-2.87]), current smoking (1.62 [1.28-2.06]), and male sex (1.50 [1.20-1.87]), had a C statistic of 0.768. Although BMI significantly predicted mortality (odds ratio, 1.03 per unit [95% CI, 1.011.05]), it did not improve model discrimination or calibration. They subsequently divided clinical prediction rule scoring into four tiers. All-cause mortality was 0.2% in tier 1, 0.9% in tier 2, 2.0% in tier 3, and 5.2% in tier 4. “If we have to decide who should get the surgery first, it should be based on who has the highest risk of mortality,” said Arya Sharma, chair in obesity research and management, scientific director of the Canadian Obesity Network. “We looked at thousands of patient files and many different parameters, and surprisingly enough it came down to three things, if you’re male, you’re a smoker and you have diabetes, you have the highest risk. These surgeries are being done, but are the wrong people getting them? The current BMI cut-off is missing the boat on those who need it most. Having diabetes is more important than BMI as a risk factor. Our research showed BMI didn’t really matter, so size alone isn’t a good way to decide who should get the surgery.” The research showed that diabetes was the strongest predictor of death, noting that obese patients with diabetes were more than twice as likely to die as obese patients without diabetes. Smoking increased risk of death 1.6 times, and being male increased risk 1.5 times. “We think this will be a useful tool for physicians,” added Padwa. “It’s simple math that will predict a patient’s risk of death. For example, if you’re a middle-aged, male smoker with diabetes, your risk of dying in 10 years is 10 times higher than that of a young, female non-smoker who doesn’t have diabetes – irrespective of BMI.” The research was funded by the Canadian Institutes of Health Research. 22 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 Side effects high for kidney disease patients following surgery Invitation to the 6th Congress of IFSO EC 2014 in Brussels Dear friends and colleagues, K idney disease patients who undergo bariatric surgery can successfully lose weight, but many experience significant side effects, according to a study, “Safety and Efficacy of Bariatric Surgery in Obese Patients with CKD: The London Renal Obesity Network (LonRON) Experience”, at American Society of Nephrology Kidney Week 2013, in Atlanta, GA. Although bariatric surgery is currently the most effective treatment for obesity, recent evidence suggests the complication rate may be higher in those with chronic kidney disease than in those without. As a result, Helen MacLaughlin and colleagues from King’s College London, UK, conducted a retrospective study of all obese patients with kidney dis- Kidney_x_ray_red ease who underwent laparoscopic bariatric surgery in three major London teaching hospitals from 2007 to 2012. Data from 74 patients’ medical records revealed that across all forms of surgery; 38% underwent Roux-en-Y bypass (RYGB), 57% sleeve gastrectomy and 5% adjustable gastric banding. Eleven percent of patients were classified as CKD stages 1-2, 59% CKD stage 3, 12% CKD stage 4/ stage. Eighteen percent of patients were on haemodialysis at the time of surgery. Excess weight was lost in 61% of patients one year post-surgery. There were 16 adverse events, including two deaths (3%) related to surgical complications. Acute kidney injury was most frequent (4%), followed by leak (3%), acidosis and elevated blood potassium levels (3%), post-operative chest infection (3%), vitamin B12/ iron deficiency (3%), fistula/graft failure (3%), and heart attacks (1%). An additional four deaths occurred during the study period, including two related to cancer. “While bariatric surgery is effective for weight loss in obese patients with chronic kidney disease, the adverse event and mortality rates are high,” the authors concluded. “Identification of risk factors for adverse events and investigation of non-surgical alternatives remain priorities.” The study authors called for further research to identify risk factors for harmful side effects and death, and for nonsurgical alternatives to help obese kidney disease patients lose weight. The BeSOMS (Belgian Section for Obesity and Metabolic Surgery) is proud to invite you to the 6th IFSO EC congress in Brussels from Wednesday 30 April till Saturday 3 May 2014. Belgium has a long history of Laparoscopic and Bariatric Surgery. From the earliest bariatric procedures in Belgium dating already from 1970 and the first ‘laparoscopic placement’ of a gastric band in 1992 towards now, Belgian general surgeons have endorsed emphatically bariatric and metabolic surgery. On a population of 11 million people, more than 100 surgeons are performing more than 8,000 bariatric procedures per year. Several colleagues are world leaders in the bariatric field and are at the cutting edge of new evolutions and developments. This will guarantee a high scientific level of the meeting. Even if some of you could think that everything has been said, as well for the surgical techniques as for the metabolic approach, things are still evolving every day. Standard and new surgical techniques and also metabolic surgery will be discussed with a special focus on long term results. We are also proud to organize the 3rd European Obesity Medico-Surgical Workshop as a formal satellite of IFSO EC 2014 jointly organized by IFSO EC and EASO. It will be a one-day workshop where surgeons and endocrinologist will have the opportunity to discuss items of common interest. Brussels, the Capital of Europe, will take care of the hosting and your comfort. The meeting will take place in the brand new Congress Center, the Square, which is situated in the center of Brussels in walking distance of the Grand Market Place, one of Europe most beautiful historical settings. All the hotels are also in walking distance of the Square. Brussels is the center of Belgium. Beautiful cities such as Bruges, Ghent, Antwerp and Liège can be reached in less than two hours drive. Apart from the top restaurants, we have more than 600 different beers to taste. Belgium is a nation of artistic giants such as our world famous painters Rubens, Breughel, Ensor, Delvaux and Magritte. We are convinced you will have an unforgettable stay in Brussels. Luc Lemmens Important Dates in 2014: Deadline for Symposium Submission 15 January Deadline for Abstract Submission 1 February Early Bird registration 1 March Regular Registration 1 April Late registration 24 April The pros of pre-bariatric surgery psychological interview Dr Edward Lurey is a licensed clinical psychologist and is currently a member of the NC Psychological Association, The American Psychological Association, American Society for Metabolic and Bariatric Surgery, The Society for Behavioral Medicine and The Academy for Eating Disorders. E very adult was once a child. And every child has experienced pain in the process of growing up. None of us escape the criticism from parents, other adults and especially other children. One does not have to go back very far in time to read about girls who have chosen to commit suicide rather than endure the taunts of other children now utilizing social media to cast even more stones of disparagement and humiliation. In my years of working with people who are suffering from eating disorders. I have concluded there are five hateful, wounding words that leave very deep and enduring scars. Each of these words referring to their character are used to label children (and adults) leaving very deep and lasting scars to their self-esteem and confidence. One additional behavior that could be added to the list of shame builders, and that is dealing with one’s sexual behaviour. Most assumed character defects are invisible to the naked eye with the exception of the last two; fat and ugly. Although we still maintain a sense of decency in our society by not directly saying to a person’s face that they are ugly, telling someone they are fat or questioning ‘you put on a few?’; is the last of the socially condoned statements that show no signs of abating in western society. Very overweight children and adults are seen in more negative ways than their slimmer counter parts, and the psychological remnants and mental scars are very deep and difficult to eliminate or eradicate from one’s own self-assessment of who you are on the inside. You know, the real you.....what you really think about yourself seems to be correct when you judge you. In 1991 the NIH recommended that two elective surgical procedures were required to pass approval from a psychologist prior to the surgery. The two surgeries were gender reassignment and bariatric surgery. At that time Rouxen-Y was the only bariatric surgery available and was not considered to be a reversible procedure nor was sex change. Both of these radically different surgeries have common elements. They are both considered to be irreversible. Once performed, neither can be easily or completely returned to their original physiological state. They also involve a significant psychological changes in self perception and self esteem, the foundations having been under construction since early childhood and adolescence. By the time a patient fulfills the required psychological approval, most of them are in the 30 to 60 year range. They are seeking relief from many years of emotional pain and suffering inflicted by society, friends and family who have treated them like ‘lepers’ among us due to their excessive weight. Many see themselves as morally and mentally deficient because they have ‘allowed’ themselves to become morbidly obese. And initially, bariatric surgery does provide them with fulfilment, increased self-esteem, and self-confidence that accompanies a significant loss of weight. But eventually the body and brain reach a new state of homeostasis and the weight loss slows down, stabilizes, and in most cases people begin to regain some of their lost weight. Weight regain seems to occur with all the bariatric surgeries currently being performed. The window of opportunity to loose as much as possible appears to have a time limit. What has been termed ‘the honeymoon’ in terms of time, when a lack of any appetite comes to a end and burning excess calories slows. Previously experienced food struggles return and inertia to not exercise reappears within the mind of the person. Where do bariatric surgery patients facing these problems seek help? The nutritionist can tell you what to eat or not eat. The exercise trainer can tell you to exercise more often or more intensely. The surgeon will suggest another fill, (if you are a lap bander) or tell you to seek help from another professional. Re-enter the psychologist! A trained professional who is capable of listening and understanding people who are experiencing pain. Pain can be physical or emotional but the only way to communicate that experience is to talk with someone who understands. Not only understands, but has the knowledge and training in helping people who are DON’T CALL ME… 1. Stupid, 2. Lazy, 3. Crazy, 4. Fat or 5. Ugly experiencing anxiety, depression and a paralyzing fear of failure in the future. Cognitive behavioural therapy is the treatment modality of choice to assist a struggling patient. Psychologists help patients understand the chain of mental events that are composed of Thoughts, Feelings, and resulting behaviours. An intervention of any of those factors results in changes. The psychologist is one member of the team, who surgical candidates probably dreaded seeing most in their initial pre surgical evalu- On behalf of the Belgian Section for Obesity and Metabolic Surgery (BeSOMS) President of the 6th IFSO-EC Congress Past-President of IFSO-EC 2008-2010 ations. Before seeing a psychologist for their pre surgical evaluation, it is rare they have professionally encountered a psychologist. And most have never talked with a psychologist (concern over the labels, crazy, lazy, stupid and fat) and many are extremely anxious when they arrive for their initial appointment. A portion of my interview session is devoted to explaining the results of the psychological tests they turned in prior to their appointment. Another portion of the session is devoted to asking and assessing the patients knowledge and commitment to what they are about to undertake. A tenuous bond, is established between the candidate and psychologist as a part of the team approach that is vital to the continued success of the patient who will undergo surgery. I take a picture at the end of the appointment for ‘graduation’, as most patients have a very difficult time really ‘seeing’ themselves when they return for the next requested scheduled appoint at six months post-surgery and at one year. Body image is a resistant self-belief irrespective of what others can say to the person. Few of my anorexic patients can really ‘see’ themselves except in pictures and I believe the same is true for bariatric patients that have lost significant weight over the last six to eighteen months. Typically, they use one word to describe what they see, “Wow”. In summary, I believe the initial psychological evaluation is important to orient and familiarize the patient with a treatment team member wishing to assist them in a difficult change in life. A one-time meeting is the beginning of a relationship that may be very helpful to many patients who are not feeling total success in their surgical results. 24 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 Objective scale published to rate bariatric centres Study compared with using individual characteristics at surgical centres to measure site quality A n objective measure that includes procedure complications, patient and surgeon volume, and other outcomes provided a more suitable scale when rating centres that perform bariatric surgery, according to researchers from the University of Michigan. Published online in JAMA Surgery (Dimick et al. Composite Measures for Profiling Hospitals on Bariatric Justin Dimick Surgery Performance. 2013.), the paper compares with using individual characteristics at surgical centres to measure site quality, which did not achieve significance, the composite scale was able to differentiate risk of complications between low-scoring and high-scoring centres (OR 1.99, 95% CI 1.14-3.47). The researchers stated that the optimal approach for profiling hospital performance with bariatric surgery is unclear, so they set out to develop a novel composite measure for profiling hospital performance with bariatric surgery. The objective rating scale for surgical centres was published shortly after an announcement from the Centers for Medicare and Medicaid Services saying they would eliminate certification requirements for facilities that offer bariatric procedures, citing that certification was not associated with improved outcomes at bariatric surgery centres. The new measure was developed through data acquired from the Michigan Bariatric Surgical Collaborative clinical registry on 2,942 patients who underwent bariatric surgery in Michigan from 2008 to 2010. The registry includes 29 hospitals and 75 surgeons, and collects information on patient characteristics, procedure type, processes of care, and postoperative outcomes. The procedures included in the study were open and laparoscopic gastric bypass, adjustable gastric banding, sleeve gastrectomy, and biliopancreatic diversion with duodenal switch. The scale included scores for hospital volume, risk-adjusted complication rates, risk- and reliability-adjusted complication rates. Hospitals were scored on each of these categories individually and as a composite scale. Study The authors, led by according to Dr Justin Dimick of the Center for Healthcare Outcomes and Policy at the University of Michigan in Ann Arbor, limited complications used in the scale to those considered potentially life threatening, grade II, or worse. These included abdominal abscess, bowel obstruction, leak, bleeding, wound infection or dehiscence, respiratory failure, venous thromboembolism, bandrelated problems that required reoperation, myocardial infarction, cardiac arrest, renal failure requiring long-term dialysis, and death. Adjustments were made based on patients’ BMI, mobility limitations, smoking status and comorbid conditions. These comorbidities included pulmonary disease, cardiovascular disease, sleep apnoea, psychological disorders, prior venous thromboembolism, diabetes, chronic renal failure, urinary incontinence, gastro-oesophageal reflux disease, peptic ulcer disease, cholelithiasis, previous ventral hernia repair, and musculoskeletal disorders. Risk and reliability measures were based on centre size-adjusted complication rates, such as mortality, incidence of other complications, reoperation, readmission, and length of stay. Quality measures were given weighted scores. Patients were well matched across hospitals when scored through the composite measure. Centres were scored on a three-star rating scale; 3-star (top 20%), 2-star (middle 60%), and 1-star (bottom 20%). They assessed how well these ratings predicted outcomes in the next year (2010) compared with other widely used measures. Outcomes The results showed that composite measures explained a larger proportion of hospital-level variation in serious complication rates with laparoscopic gastric bypass than other measures. For example, the composite measure explained 89% of the variation compared with only 28% for risk-adjusted complication rates alone. Composite measures also appeared better at predicting future performance compared with individual measures. When ranked on the composite measure, 1-star hospitals had 2-fold higher serious complication rates (4.6% vs 2.4%; odds ratio, 2.0; 95% CI, 1.1-3.5) compared with 3-star hospitals. Differences in serious complication rates between 1- and 3-star hospitals were much smaller when hospitals were ranked using serious complications (4.0% vs 2.7%; odds ratio, 1.6; 95% CI, 0.8-2.9) and hospital volume (3.3% vs 3.2%; odds ratio, 0.85; 95% CI, 0.4-1.7). “Composite measures are much better at explaining hospitallevel variation in serious complications and predicting future performance than other approaches,” the authors conclude. “In this preliminary study, it appears that such composite measures may be better than existing alternatives for profiling hospital performance with bariatric surgery.” The study was supported by the Agency for Healthcare Research and Quality and the National Institute of Diabetes and Digestive and Kidney Diseases. Video rating effective when assessing bariatric surgeons Surgeons who received low skill scores had complication rates of 14.5% vs. 5.2% among high skill surgeons R ating a surgeons’ operating skills by video technology successfully predicted whether patients would suffer complications after they leave the operating room, according to a University of Michigan Health System study. The study, ‘Surgical skill and complication rates after bariatric surgery published in the New England Journal of Medicine, assessed the relationship between the technical skill of bariatric surgeons and postsurgery complications in 10,343 patients undergoing common, but complex laparoscopic gastric bypass surgery. “Peer assessment of a surgeon’s operative skill may be a more practical, more direct, and ultimately more informative test for assessing the surgeon’s proficiency than other measures,” said lead study author Dr John D Birkmeyer, professor of surgery and director of the Center for Healthcare Outcomes & Policy at the University of Michigan. The researchers write that although it has been assumed that the proficiency of the operating surgeon is an important factor underlying such variation, empirical data are lacking on the relationships between technical skill and postoperative outcomes. As a result they conducted a study involving 20 bariatric surgeons in Michigan who participated in a statewide collaborative improvement programme with each surgeon submitting a single representative videotape of himself or herself performing a laparoscopic gastric bypass. Participation was voluntary and various skills such as a gentleness, time and motion, instrument handling, flow of operation, tissue exposure and overall technical skill were rated anonymously. Every videotape was rated in various domains of technical skill on a scale of one to five (with higher scores indicating more advanced skill) by at least ten peer surgeons who were unaware of the identity of the operating surgeon. The relationships between these skill ratings and risk-adjusted complication rates were then assessed, using data from a prospective, externally audited, clinical-outcomes registry involving 10,343 patients. Results The outcomes showed that the mean summary ratings of technical skill ranged from 2.6 to 4.8 across the 20 sur- geons. The bottom quartile of surgical skill, as compared with the top quartile, was associated with higher complication rates (14.5% vs. 5.2%, p<0.001) and higher mortality (0.26% vs. 0.05%, p=0.01). The lowest quartile of skill was also associated with longer operations (137 minutes vs. 98 minutes, p<0.001) and higher rates of reoperation (3.4% vs. 1.6%, p=0.01) and readmission (6.3% vs. 2.7%) (p<0.001). “The technical skill of practicing surgeons varied widely,” said Birkmeyer. “Summary ratings varied from 2.6 to 4.8 and greater skill was associated with fewer postoperative complications and shorter operations.” In the study, surgeons who received low skill scores had complication rates of 14.5 percent compared to 5.2 percent among high skill surgeon. “Variation in surgical skill and outcomes may never be eliminated,” he added. “But coaching and constructive feedback from peers may be an important strategy for upping everyone’s game.” The authors added that the findings also suggest the formal evaluations of technical skill may be useful in identify- ing which medical students pursue careers as surgeons and in evaluating surgeons in training. For surgeons already in practice, similar methods could be invaluable for the board re-certification process and hospital credentialing for specific procedures. “The technical skill of practicing bariatric surgeons varied widely, and greater skill was associated with fewer postoperative complications and lower rates of reoperation, readmission, and visits to the emergency department,” they concluded. “Although these findings are preliminary, they suggest that peer rating of operative skill may be an effective strategy for assessing a surgeon’s proficiency.” Improved body image and sex drive after bariatric surgery The researchers also report that two years after surgery, woman also saw improvements in most reproductive hormone levels B ariatric surgery not only results in years of sustained weight loss but improves body image and increased sexual satisfaction, according to a study, ‘Changes in Sexual Functioning and Sex Hormone Levels in Women Following Bariatric Surgery’, published in JAMA Surgery. “For many people, sex is an important part of quality of life. The massive weight losses typically seen following bariatric surgery are associated with significant improvements in quality of life,” said the study’s lead author Dr David Sarwer, professor of Psychology in Psychiatry and Surgery in the Perelman School of Medicine at the University of Pennsylvania. “This is one of the first studies to show that women also experience improvements in their sexual functioning and satisfaction, as well as significant improvements in their reproductive hormones.” Researchers from the University of Pennsylvania conducted a study to ascertain whether bariatric surgery affects women’s sex drive and satisfaction. They examined sexual functioning and sex hormone levels, as well as quality of life, body image and depressive symptoms. They report that during these years of sustained weight loss, the women reported additional benefits, including improvements in body image and increased sexual satisfaction. The researchers also report that two years after surgery, woman also saw improvements in most reproductive hormone levels. “These results suggest that improvements in sexual health may be added to the list of benefits associated with large weight losses seen with bariatric surgery,” the authors note. “Two years following surgery, women reported significant improvement in overall sexual functioning and specific domains of sexual functioning: arousal, lubrication, desires and satisfaction.” The American Psychological Association states that obesity and depression often go hand in hand, obesity in women is associated with a 37% increase in major depression. The study included 106 women who underwent bariatric surgery. The women lost an average of 32.7 percent of their initial body weight in the first year and an average 33.5 percent at the second postoperative year. “Our study provides new information on changes in sexual functioning, reproductive hormone levels, and psychosocial functioning in women in the first 2 years after bariatric surgery,” the authors conclude. “These results suggest that improvements in sexual health may be added to the list of benefits associated with large weight losses seen with bariatric surgery. Future studies should investigate if these changes endure over longer periods of time, and they should investigate changes in sexual functioning in men who undergo bariatric surgery.” bariatricnews.net 25 ISSUE 18 | DECEMBER 2013 Variety of factors impact on effectiveness of surgery Non-Hispanic black and Hispanic patients were less likely than non-Hispanic white patients to experience metabolic syndrome remission T he impact of bariatric surgery on risk factors for cardiovascular disease depends on a variety of factors, including the type of surgery, sex of the patient, ethnic background, and pre-surgery body mass index, according to a Kaiser Permanente study published in Annals of Surgery (Coleman et al Metabolic Syndrome Is Less Likely to Resolve in Hispanics and Non-Hispanic Blacks After Bariatric Surgery. 2013). Researchers examined the electronic health records of more than 4,000 Kaiser Permanente patients in Southern California who had bariatric surgery for weight loss between 2009 and 2011 to determine what factors led to remission or reduction of metabolic syndrome after surgery. Patients were studied for up to two years after their bariatric surgery to determine if their metabolic syndrome improved. The researchers report that nonHispanic black and Hispanic patients were less likely than non-Hispanic white patients to experience metabolic syndrome remission. These differences in remission were not a result of greater weight loss during the follow-up period, and these racial and ethnic differences persisted even when researchers controlled for the rate of weight loss. “In the majority of patients, bariatric surgery may result in the remission of many cardiovascular disease risk factors, which could prevent those patients from experiencing more serious health conditions, such as heart attack and stroke,” said study lead author, Dr Karen J Coleman of the Kaiser Permanente Department of Research & Evaluation in Pasadena, CA. “The benefits of bariatric surgery are different for men and women and different racial/ethnic groups. This study highlights the importance of designing post-operative care models to address the unique challenges different genders and ethnic/racial groups face following bariatric surgery.” The paper also reports that researchers also found women were more likely than men to experience remission and patients who were heavier at the time of their surgery were less likely to experience remission than those who were lighter. However, the effects of age, race/ ethnicity, and BMI at the time of surgery remained after accounting for weight loss. Interestingly, patients who received the gastric sleeve were less likely to experience metabolic syndrome remission than patients who had a traditional gastric bypass. Some individual markers of cardiovascular health were more likely to improve than others following bariatric surgery. For example, 44 percent lost enough weight following surgery to no longer be considered obese, and a significant 85 percent of patients’ blood pressure returned to healthy levels. The study included patients who had a laparoscopic Roux-en-Y gastric Lyon (France) April 25–26, 2014 IV International Symposium on Non Invasive Bariatric Techniques bypass or a laparoscopic vertical sleeve gastrectomy between 2007 and 2009 (n=4088) without revision during the study period of January 2007 and December 2011. Diagnosis and resolution of metabolic syndrome were determined using standard criteria with electronic medical records of laboratory, diagnosis, and pharmacy information. Nearly half (49 percent) of the Kaiser Permanente study’s sample were either Hispanic or non-Hispanic black, providing a unique opportunity to study the effect of bariatric surgery on metabolic syndrome in different racial/ethnic groups. Conclusion “Although we do not know the reasons for the racial and ethnic differences we saw, one explanation could be that the black and Hispanic patients had surgery when they are much heavier and sicker than the non-Hispanic white patients,” said Coleman “Our study highlights that surgery may be an important intervention tool for people earlier in their weight gain trajectory. The heavier they become, the less likely that surgery will be successful at reducing these cardiovascular disease risk factors.” Based on the findings they conclude that bariatric surgery may be most effective for patients who are younger and early in the course of their cardiometabolic disease. Future research should investigate the factors that lead to lower rates of disease resolution after bariatric surgery for Karen Coleman racial/ethnic minority groups. 26 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 Surgical benefits demonstrated out to three years S everely obese patients who have a gastric bypass or laparoscopic adjustable gastric band experience substantial weight loss three years after surgery, with most of the change occurring in the first year, according to researchers from the University of Pittsburgh’s School of Medicine and Graduate School of Public Health. The study findings, published online in the Journal of the American Medical Association (Courcoulas et al. Weight Change and Health Outcomes at three Years After Bariatric Surgery Among Individuals With Severe Obesity), also found variability in both weight change and improvements in obesity-related complications, including diabetes, hypertension and high cholesterol. “Bariatric surgery is not a ‘one size fits all’ approach to weight loss,” said lead researcher, Dr Anita Courcoulas, a bariatric and general surgeon at Magee-Womens Hospital of UPMC. “Our study findings are the result of data collected from a multicentre patient population, and emphasise the heterogeneity in weight change and health outcomes for both types of bariatric surgery that we report.” Study The researchers examined data from the Longitudinal Assessment of Bariatric Surgery (LABS) Consortium, a multi-centre observational cohort study, encompassing ten hospitals in six geographically diverse clinical centres and a data coordinating centre, that assesses the safety and efficacy of bariatric surgical procedures performed in the US. The researchers gathered highly standardised assessments and measures on adult study participants undergoing bariatric surgery procedures and followed them over the course of three years. The research included 1,738 participants who underwent bypass surgery and the 610 participants who received a gastric band. The 110 participants who underwent the less commonly performed procedures in LABS-2 were not included. In the three-year follow-up after bariatric surgery, the researchers observed substantial weight loss for both procedures, with most of the change occurring during the first year. Participants who underwent gastric bypass surgery or laparoscopic adjustable gastric banding experienced median weight loss of nearly 32 percent and 16 percent, respectively. Additionally, of the gastric bypass surgical participants who had specific obesity-related health problems prior to surgery, 67 percent experienced partial remission from diabetes and 38 percent remission from hypertension. High cholesterol resolved in 61 percent of the participants who underwent bypass surgery. For those who underwent laparoscopic adjustable gastric banding, 28 percent and 17 percent experienced partial remission from diabetes and remission from hypertension respectively, and high cholesterol was resolved in 27 percent of participants. “LABS-2 data confirm in a heterogeneous population with a high degree of follow-up that RYGB and LAGB were associated with significant weight and health improvements at three years after sur- Anita Courcoulas gery,” the authors conclude. “Reduction in weight and improvements in comorbid conditions with LAGB were less than reported in previous studies and not as large as those seen with RYGB. Longerterm follow-up of this cohort will determine the durability of these improvements over time and factors associated with variability in effect.” Self-reported weights are valid post-bariatric surgery S mall differences between self-reported and measured weights were found and may be due to differences in clothing, inaccurate personal scales, time between measurements, or intentional misrepresentation Self-reported weights following bariatric surgery were close to measured weights, suggesting that self-reported weights used in studies are accurate enough to be used when measured weights are not available, according to a Research Letter published online by JAMA (Christian et al. Validity of Self-reported Weights Following Bariatric Surgery). Researchers from the University of Pittsburgh Graduate School of Public Health investigated whether self-reported weights following bariatric surgery differed from weights obtained by study personnel using a standard scale. They used data collected between April 2010 and November 2012 at annual assessments from the Longitudinal Assessment of Bariatric Surgery-2, an observational cohort study of 2,458 adults undergoing an initial Roux-en-Y gastric bypass (RYGB), laparoscopic adjustable gastric band (LAGB), or other bariatric procedure at ten centres. Participants were sent mailed questionnaires each year and asked to report their: (1) weight from last medical office or weight-loss program visit (self-reported medical weight) and (2) last self-weighing (self-reported personal weight). The final analysis included 988 participants, including 164 with a self-reported medical weight, 580 with a self-reported personal weight, and 244 with both self-reported weights. Across the two groups who self-reported weight, women and men underreported their weight by an average 2.2lbs. or less and the degree of underreporting was not different between women and men. Self-reported medical weights were closer to measured weights than were self-reported personal weights for both women and men. “Small differences between self-reported and measured weights were found and may be due to differences in clothing, inaccurate personal scales, time between measurements, or intentional misrepresentation,” the authors write. “Self-reported weights after bariatric surgery may be more accurate because participants who undergo surgery to lose weight may be especially attentive to their weight.” “In conclusion, self-reported weights following bariatric surgery were close to measured weights. This suggests that selfreported weights may not unduly affect study results of surgically induced weight change and can be used when measured weights are not available.” Bariatric surgery more effective than medical therapy Paper calls for more randomised controlled trials to increase the evidence base A retrospective literature review has reported that bariatric procedures were more likely to help obese patients with type 2 diabetes to achieve benefits, than medical therapy alone. The study, which was published online in the BioMed Research International journal (Guo Xiaohu et al. The effects of bariatric procedures versus medical therapy for obese patients with type 2 diabetes: meta-analysis of randomized controlled trials. BioMed Research International, 2013), concluded that in order to provide additional evidence further intensive high-quality randomised controlled trials at multiple centres with long-term followup should be performed. The study researchers from the Department of General Surgery and the Hepatic-Biliary-Pancreatic Institute, Lanzhou University Second Hospital, Lanzhou, China, wanted to assess the effects of bariatric surgery versus medical therapy for type 2 diabetes mellitus. Following a literature search, they identified three randomised controlled trials from 269 publications. These three studies included 170 patients in the bariatric surgery group and 100 patients in the medical therapy group. They reported that compared with medical therapy, bariatric surgery for type 2 diabetes can significantly decrease the levels of HbA1c, FBG, weight, triglycerides, and the dose of hypoglycaemic, antihypertensive, and lipid-lowering medicine, while increasing the rate of diabetes remission (RR=9.74, 95%CI, (1.36, 69.66)) and the levels of high-density lipoprotein. However, they noted are no statistical differences in serious adverse events between the surgical and medical groups (RR=1.23, 95%CI, (0.80, 1.87)). Only two of the studies reported the diabetes remission rates, with significant heterogeneity between surgical and medical groups (I2 = 53%, p=0.03). Bariatric surgery was associated with significantly increasing the diabetes remission (RR=9.74, 95% CI, (1.36, 69.66)). Schauer et al. reported that proportion of patients with HbA1c ≤ 6% was 39.39% in surgical group and 12% in medical group, 12 months after surgery. Overall, they noted that the results suggested that bariatric surgery could effectively improve patients’ glycaemic control after two years after undergoing operations. “This meta-analysis showed that bariatric procedures could significantly induce and maintain well-glycaemic control, which was confirmed by the results of several other studies,” they write. “The gastric bypass, gastric banding, gastrectomy, and biliopancreatic diversion decreased HbA1c by 0.79%, 1.13%, 0.89%, and 3.46%, respectively, when compared with medical therapy; the gastric bypass, gastric banding, and biliopancreatic diversion decreased FBG by 23.44%, 32.8mg/dL, and 27.14% at baseline, respectively.” The investigators also highlighted significant differences in the change in the number of patients without hypoglycaemia between all surgical groups and medical groups. Patients in the gastric bypass group, gastric banding group and sleeve gastrectomy group all significantly increased the number of subjects without hypoglycaemia compared with medical group. With regard to weight loss, bariatric procedures significantly decreased the patients’ weight, compared with medial therapy alone. “The results of our meta-analysis showed that bariatric surgery could not only significantly decrease the levels of HbA1c, FBG, the amount of medicines (including hypoglycaemic, antihypertensive, and lipid-lowering ones), weight, and triglycerides,” the authors note, “but also increase the rate of diabetes remission and the levels of high-density lipoprotein. Meanwhile, there were no statistical differences in the serious adverse events between surgical and medical groups.” The researchers acknowledge that their meta-analysis is limited by the scarcity of research, the different operative methods and procedures performed by different surgeons, and the small follow-up period (12-24 months). To overcome this shortfall of empirical data, they call for the creation of additional randomised controlled trials to confirm their findings. bariatricnews.net 27 ISSUE 18 | DECEMBER 2013 Lap bands reduce cardiovascular disease risk Study adds to the evidence of the cardiovascular benefits of significant weight loss P atients undergoing laparoscopic adjustable gastric band (LAGB) have significant weight loss and reductions in estimated ten to 30-year cardiovascular risk within one year post-LAGB, according to a study published in the journal Advances in Therapy (Reduction in Framingham risk of cardiovascular disease in obese patients undergoing laparoscopic adjustable gastric banding. 2013:2013 30(7):684-96), a Springer link publication. Data from a US healthcare database revealed that ten- and 30-year estimated cardiovascular risk decreased from 10.8 to 7.6% (p\0.0001) and 44.34 to 32.30% (p\0.0001), respectively, 12–15 months post-LAGB. Improvements were significantly greater than in non-LAGB patients (n= 4,295) (p\0.0001). The researchers set out to examine whether weight loss in obese patients treated with LAGB is associated with meaningful reductions in estimated 10- and 30- year Framingham CVD risk 12–15 months post-LAGB. Obese adult patients (BMI30) treated with LAGB were identified in a large US healthcare database. Patients without CVD at baseline and with measures of BMI, systolic blood pressure, diabetes, and smoking status at baseline and follow-up were eligible. Non- LAGB patients were propensity score matched to LAGB patients on baseline BMI, age, and gender. The estimated 10- and 30-year Framingham CVD risks were 10.8 and 44.34% for LAGB patients and 10.56 and 41.79% for comparison patients at baseline, respectively. Results The outcomes showed that the mean BMI in LAGB patients (n= 647, average age 45.66 years, 81.1% female) decreased from 42.7 to 33.4 (p\0.0001), with 35.4% no longer obese. In the subset with lipid data (n=74), improvements in total (-20.6mg/dL; p\0.05) and highdensity lipoprotein (10.6 mg/dL, p\0.0001) cholesterol one year post-LAGB were also observed. At 12–15 months’ follow-up, mean BMI decreased significantly in LAGB patients (-9.3kg/m2, p\0.0001) and in comparison patients (-0.6kg/m2, p\0.0001. In addition, the researchers also report that there were significant reductions in SBP for both LAGB (p\0.0001) and comparison patients (p\0.05). At follow-up, the proportion of patients using anti-diabetic medications decreased in LAGB patients (p\0.0001) and increased in comparison group (p\0.01). Estimated 10- and 30-year CVD risk scores decreased SM-BOSS study Continued from page 7 Figure 1: Change in estimated 10- and 30-year CVD risk at 12–15 months by gender and baseline BMI. BMI body mass index, CVD cardiovascular disease, LAGB laparoscopic adjustable gastric banding. *P\0.05 for changes from baseline between LAGB and non-LAGB groups; BMI was presented as kg/m2. ing LAGB to have significant weight loss, and reduced CVD risk factors and estimated CVD risk, supporting the effectiveness of the LAGB procedure as a potential approach for management of obesity. “These results add to the evidence of the cardiovascular benefits of significant weight loss among obese individuals and the potential long-term clinical impact of the LAGB procedure as a therapeutic intervention for obesity,” the researchers write. “Larger and long-term studies are needed to further document whether effects of LAGB on weight loss and CVD risk factors translate into reduced CVD incidence.” Conclusion The analysis and publication The researchers concluded that charges were sponsored by Althe data showed patients receiv- lergan. significantly in LAGB patients (-3.2%, p\0.0001 and -12.04%, p\0.0001, respectively), but did not change significantly in comparison patients ( 0.01%, p= 0.91 and 0.13%, p= 0.42, respectively). Changes in CVD risk factors and scores were evaluated for subgroups stratified by gender and baseline BMI (Figure 1). Although the authors acknowledge that Framingham CVD risk scores have not been validated for measuring changes in CVD risk over time or specifically in obese populations, “in the present analysis scores based on BMI versus lipid data indicate similar and consistent magnitude of risk reduction,” they note. ostomy and one stricture that needed endoscopic dilatation. Up to one year postoperatively, no patient had to be re-operated on for either insufficient weight loss or internal hernia in both groups. Two patients of the LSG group experienced severe GERD symptoms, but until one year after the operation, none of them agreed to have undergone conversion to LRYGB. “Strictures or torsions of the gastric sleeve are complications that are difficult to treat and often result in the resection of the gastric sleeve at the end of the treatment line,” the authors warn. “Therefore, it is utmost important that this procedure is performed with the best standardised technique by experienced bariatric surgeons.” The incidence of micronutrient deficiency was equal in both groups (LSG: n=28 patients; LRYGB: n= 27 patients), with vitamin D deficiency being the most frequent deficiency, followed by vitamin B12 deficiency (LSG: n=7; LRYGB: n=15; p<0.12). Conclusions They authors state that LSG is best suited for patients with pre-existing GERD are at a risk of dete- rioration after LSG and should rather undergo LRYGB, for patients who expected major adhesions, who need a staged concept or suffer from Crohn disease. The researchers believe that this tailored approach allows the bariatric surgeon to take into account the patients’ preoperative risk profile and will optimise the long-term results of bariatric surgery. “We could show that LSG and LRYGB are equally efficient regarding weight loss, reduction in comorbidities, and increase in quality of life at one year,” the authors conclude. “Therefore, we believe that LSG is a valuable surgical alternative for selected patients with morbid obesity.” Gastic sleeve 28 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 Study also identified the factors that result in a higher rate of long-term diabetes remission O verweight patients with type 2 diabetes continue to experience the benefits of bariatric surgery up to nine years after the procedure, according to research published in the Annals of Surgery (Brethauer et al. Can diabetes be surgically cured? Long-term metabolic effects of bariatric surgery in obese patients with type 2 diabetes mellitus. 2013;258(4):628-36). According to the researchers, the study shows that obese patients with type 2 diabetes continue to improve or reverse their diabetes, as well as reduce their cardiovascular risk factors, nine years after the procedure. “Uncontrolled diabetes can lead to serious complications such as heart and kidney disease. Only about half of diabetics in the United States currently have acceptable control of their blood glucose level,” said lead investigator Dr Stacy Brethauer of the Cleveland Clinic Bariatric & Metabolic Institute. “Our study, however, shows that 80 percent of the diabetic patients still control their blood glucose five years after their bariatric surgery. Additionally, nearly one-third of gastric bypass patients had normal blood glucose levels off medication for over five years after surgery. This study confirms that the procedure can offer durable remission of diabetes in some patients and should be considered as an earlier treatment option for patients with uncontrolled diabetes.” The study also identified the factors that result in a higher rate of long-term diabetes remission. Long-term weight loss, a shorter duration of diabetes prior to surgery (less than five years), and undergoing gastric bypass surgery compared to adjustable gastric banding are the biggest predictors of sustained diabetes remission. The retrospective study analysed data on 217 patients with type 2 diabetes who underwent bariatric surgery between 2004 and 2007 and had at least five years follow-up. The patients were divided into three groups: 162 patients underwent gastric bypass surgery, 32 had the gastric banding procedure done, and 23 underwent sleeve gastrectomy. Researchers used strict criteria to define glycaemic control, including an HbA1c level of less than six percent, which is a more aggressive target than the American Diabetes Association (ADA) guidelines. Of a HbA1c target of seven percent. At a median follow-up of six years, data show that diabetes remission occurred in 50 percent of patients after bariatric surgery. Specifically, 24 percent of patients sustained complete remission of their diabetes with a blood sugar level of less than six percent without diabetes medications, and another 26 percent achieved partial remission; 34 percent of all patients improved their long-term diabetes control compared to presurgery status. As expected, the patients who received gastric bypass experienced the highest rates of weight loss and diabetic remission. The study shows significant reductions Picture courtest of Dr Stacy A Brethauer and ASMBS Benefits from surgery evident after nine years Stacy Brethauer in the number of diabetic medications used in the long-term follow-up. There was a 50 percent reduction in the number of patients requiring insulin therapy in the long term and a 10-fold increase in the number of patients requiring no medications. In addition, the data show patients significantly reduced their cardiovascular risk factors according to the Framingham Risk Score. Diabetic nephropathy, characterized by high protein levels in the urine, improved or stabilised as well. Shorter duration of T2DM (p<0.001) and higher long-term EWL (p=0.006) predicted long-term remission. Recurrence of T2DM after initial remission occurred in 19% and was associated with longer duration of T2DM (p=0.03), less EWL (p=0.02), and weight regain (p=0.015). Long-term control rates of low highdensity lipoprotein, high low-density lipoprotein, high triglyceridemia, and hypertension were 73%, 72%, 80%, and 62%, respectively. Diabetic nephropathy regressed (53%) or stabilised (47%). “Bariatric surgery can induce a significant and sustainable remission and improvement of T2DM and other metabolic risk factors in severely obese patients,” the authors conclude. “Surgical intervention within five years of diagnosis is associated with a high rate of long-term remission.” Contouring can improve weight control after bypass Insurance should cover body contouring B ody contouring surgery to remove excess skin improves long-term weight control in patients after gastric bypass surgery, claims a study in Plastic and Reconstructive Surgery, the journal of the American Society of Plastic Surgeons. Since maintaining weight loss to reduce long-term health problems is the key goal of bariatric surgery, the researchers believe that body contouring should be considered reconstructive rather than cosmetic surgery for patients who have achieved massive weight loss. “We demonstrated that patients with body contouring present better long-term weight control after gastric bypass,” said study author, Dr Ali Modarressi and colleagues of University of Geneva, Switzerland. The researchers compared longterm weight outcomes for two groups of patients who underwent gastric bypass surgery. In 98 patients, gastric bypass was followed by body contouring procedures to remove excess fat and skin. A matched group of 102 patients with similar characteristics underwent gastric bypass alone, without body contouring. Body contouring surgery usually consisted of abdominoplasty (tummy tuck), often with other procedures to remove excess skin from the breasts, legs and upper arms. Within two years after gastric bypass, the patients had lost an average of nearly 100lbs. In subsequent years, patients who underwent body contouring regained less weight: an average of just over one pound per year, compared to 4lbs per year for patients who had gastric bypass only. Seven years after gastric bypass, patients who underwent body contouring surgery achieved an average weight of 17lbs, and those with bariatric surgery alone, 220lbs. The average weight before gastric bypass was 275lbs in both groups. Patients who underwent body contouring had regained about four percent of their initial body weight, compared to 11 percent for those who had gastric bypass only. After accounting for the weight of excess skin removed, average weight regain was about 14lbs in patients who had gastric bypass plus body contouring, compared to nearly 50lbs with gastric bypass only. The researchers believe their study adds to the argument that body contouring should be considered an essential part of successful bariatric surgery and, because of its favourable effects on patient health, should be covered by insurance plans. “Therefore, body contouring must be considered as a reconstructive operation in the treatment of morbid obesity,” the researchers conclude, “Since plastic surgery after massive weight loss is mandatory for quality of life improvement and weight loss maintenance in many patients, body contouring must be considered a reconstructive surgery for those who have achieved massive weight loss. American societies publish obesity practice guidelines New guideline urges healthcare providers to actively help their patients achieve and maintain a healthier body weight Healthcare that includes developing individualised plans and focusing on behaviour change is key to curbing obesity C omprehensive treatment recommendations to help healthcare providers tailor weight loss treatments to adult patients affected by overweight or obesity have been published by the American Heart Association, American College of Cardiology and Obesity Society. The joint guidelines is published simultaneously Circulation: a journal of the American Heart Association, Journal of the American College of Cardiology and Obesity: Journal of The Obesity Society. “Weight loss isn’t about will power. It’s about behaviours around food and physical activity, and getting the help you need to change those behaviours,” said Dr Donna Ryan, co-chair of the writing committee and professor emeritus at Louisiana State University’s Pennington Biomedical Research Center in Baton Rouge, LA. The new guideline report is based on a systematic evidence review that summarises the current literature on the risks of obesity and the benefits of weight loss, as well as knowledge on diets for weight loss, the efficacy and effectiveness of comprehensive lifestyle interventions on weight loss and weight loss maintenance and the benefits and risks of bariatric surgery. The report recommends that healthcare providers calculate BMI at annual visits or more frequently, and use the BMI cut points to identify adults who may be at a higher risk of heart disease and stroke because of their weight. The report also presents evidence showing that the greater the BMI, the higher the risk of coronary heart disease, stroke, type 2 diabetes and all-cause mortality. The new guideline recommends healthcare providers develop individualised weight loss plans that include three key components: a moderately reduced calorie diet, a programme of increased physical activity and the use of behavioural strategies to help patients achieve and maintain a healthy body weight. The best way to achieve these goals is to work with a trained healthcare professional, such as a registered dietician, behavioural psychologist or other trained weight loss counsellor, in a primary care setting, according to the recommendations. Weight loss counselling should focus on people who need to lose weight because of obesity or overweight with conditions that put them at higher risk for cardiovascular diseases, such as diabetes, high blood pressure, high blood cholesterol, a waist circumference of more than 35 inches for women and more than 40 inches for men. The most effective behaviour change programs include two to three in-person meetings a month for at least six months. Web or phone-based weight loss programs are also an option for the weight loss phase, although research shows they are not as effective as face-toface programs, according to the statement authors. Currently, comprehensive lifestyle programs that assist participants in adhering to a lower calorie diet and in increasing physical activity through the use of behavioural strategies are not widely available. “We hope that by laying out the scientific evidence that medically supervised weight loss works and significantly reduces the risk factors for cardiovascular disease, it will be more fully embraced by patients and doctors and effective programs will eventually be reimbursed by all thirdparty payers,” she added. Medicare began covering behavioural counselling for patients affected by obesity in 2012, based on available evidence at that time. Under the Affordable Care Act, most private insurance companies are expected to cover behavioural counselling and other treatments for obesity by 2014. Other key recommendations include: n Tailoring dietary patterns to a patient’s food preferences and health risks. For example, a patient with high blood cholesterol would benefit most from a low-calorie, lowersaturated fat diet including foods that they find appealing. n Focusing on achieving sustained weight loss of 5 percent to 10 percent within the first six months. This can reduce high blood pressure, improve cholesterol and lessen the need for medications to control blood pressure and diabetes. Even as little as 3 percent sustained weight loss can reduce the risk for the development of type 2 diabetes as well as result in clinically meaningful reductions in triglycerides, blood glucose and other risk factors for cardiovascular disease. n Advising adults with a BMI of 40 or higher and patients with a BMI of 35 or higher who have two other cardiovascular risk factors such as diabetes or high blood pressure, that bariatric surgery may provide significant health benefits. The guideline does not recommend weight loss surgery for people with a BMI <35 and does not recommend one surgical procedure over another. “Healthcare providers should do more than advise patients affected by obesity or overweight to lose weight – they should be actively involved and help their patients reach a health body weight,” said Ryan. The obesity guideline is one of four cardiovascular disease prevention guidelines being released by the American Heart Association and American College of Cardiology. Other guidelines address lifestyle management, cholesterol and cardiovascular risk assessment. The obesity treatment recommendations are based on the latest scientific evidence from 133 research studies. The expert panel that wrote the report was convened by the National Heart, Lung, and Blood Institute of the National Institutes of Health. At the invitation of the NHLBI, the American Heart Association, the American College of Cardiology and The Obesity Society officially assumed the joint governance, management and publication of the obesity guideline in June. Committee members volunteered their time and were required to disclose all healthcare-related relationships, including those existing one year before the initiation of the writing project. The full report, “2013 ACC/AHA Guideline for the Management of Overweight and Obesity in Adults” has been published online on the websites of the ACC and the AHA. bariatricnews.net 29 ISSUE 18 | DECEMBER 2013 Bipolar patients should be eligible for bariatric surgery Bariatric patients increase use of opioids post-surgery All-cause mortality was lower in bariatric patients than controls Calls for proactive management of chronic pain post-surgery P atients with bipolar disorder who have been evaluated as stable can be considered for bariatric surgery, according to a study published in the journal Bipolar Disorders (Ahmed et al, The effect of bariatric surgery on psychiatric course among patients with bipolar disorder. 2013). The study authors report that surgery did not increase the risk for hospitalisation or the use of outpatient psychiatric services among stable patients with bipolar disorder. The researchers included 144 severely obese patients with bipolar disorder who underwent bariatric surgery, and 1,440 control patients with bipolar disorder, matched for gender, medical centre, and contemporaneous health plan membership. Controls met referral criteria for bariatric surgery. Hazard ratio for psychiatric hospitalization, and change in rate of outpatient psychiatric utilization from baseline to years 1 and 2, were compared between groups. Results A total of 13 bariatric surgery patients (9.0%) and 153 unexposed to surgery (10.6%) had psychiatric hospitalisation during follow-up. In multivariate Cox models adjusting for potential confounding factors, the hazard ratio of psychiatric hospitalisation associated with bariatric surgery was 1.03 [95% confidence interval (CI): 0.83–1.23]. This was not significantly different to the 10.6% of 1,440 patients with bipolar disorder who did not undergo such surgery. After taking into consideration factors such as age, ethnicity, psychiatric medication use, baseline BMI, and comorbidities, the hazard ratio for psychiatric hospitalization following bariatric surgery was non-significant at 1.03, the team reports in Bipolar Disorders. There was also no significant increase in the use of psychiatric outpatient services following surgery, with only a 0.5 visit per year difference in outpatient utilisation from baseline to year 2 when compared with controls. All-cause mortality was lower in bariatric patients than controls, at 2.88 versus 8.96 deaths per 1,000 person–years of follow-up. This finding is contrary to previous study that have reported an increased risk for suicide following bariatric surgery were not supported by the study. The researchers point out that the study participants all had stable bipolar disorder, having not been admitted to hospital in the year prior to surgery and with no current substance abuse or dependence. They therefore cannot surmise how bariatric surgery affects disease course in patients with unstable bipolar disorder. “Given that patients with bipolar disorder have a higher prevalence of obesity and obesityrelated comorbidities, this suggests that people with stable bipolar disorder can be evaluated for bariatric surgery using the same criteria as other patients,” say the study authors, led by Ameena Ahmed, The Permanente Medical Group, San Francisco, California. The authors concluded that bariatric surgery did not affect psychiatric course among stable patients with bipolar disorder and that the results of the study suggest that patients with bipolar disorder who have been evaluated as stable can be considered for bariatric surgery. The study was presented at the American Psychiatric Association 165th Annual Meeting, 5–9 May 2012, Philadelphia. P atients who took chronic opioids for non-cancer pain and who underwent bariatric surgery, increased opioid use after surgery compared with before, according to a study in JAMA (Raebel et al. Chronic use of opioid medications before and after bariatric surgery. 2013;310(13):136976). Although it is not known if opioid use for chronic pain in obese individuals undergoing bariatric surgery is reduced, the authors called for proactive management of chronic pain in these patients after surgery. Marsha A Raebel of Kaiser Permanente Colorado, Denver, and colleagues conducted a study to examine opioid use following bariatric surgery in patients using opioids chronically for pain control prior to their surgery. The study included 11,719 individuals 21 years of age and older who had bariatric surgery between 2005 and 2009, and who were assessed 1 year before and after surgery, with latest follow-up by December 31, 2010. In the year before bariatric surgery, 56 percent of patients had no opioid use, 36 percent had some opioid use, and 8 percent had chronic opioid use. Among pre-surgery chronic users, 77 percent continued chronic opioid use after surgery. Relative to the year before surgery, the amount of opioid use by patients who were chronic opioid users before surgery increased by 13 percent the first year after surgery and by 18 percent across 3 post-surgery years. “There are limited options for pain management available to bariatric surgery patients because nonsteroidal, anti-inflammatory medications increase the risk of ulcers, particularly after bariatric surgery,” said Raebel. “Given the increasing chronic usage rate reported in this study, it’s clear that the medical community needs to develop better pain management programs for patients who use opioids long-term following bariatric surgery.” For the group with chronic opiate use prior to surgery, change in morphine equivalents before vs. after surgery did not differ between individuals who lost more than 50 percent of their excess body mass index vs. those who lost 50 percent or less. Neither preoperative depression nor chronic pain diagnoses influenced changes in preoperative to postoperative chronic opioid use. “We anticipated [that] weight loss after bariatric surgery would result in reduced pain and opioid use among patients with chronic pain,” the authors write. “However, patients with and without preoperative chronic pain, depression diagnoses, or both had similar increases in postoperative chronic opioid use after surgery as those without chronic pain or depression. One possible explanation is that some patients likely had pain unresponsive to weight loss but potentially responsive to opioids.” “These findings suggest the need for better pain management in these patients following surgery.” In an accompanying editorial, Dr Daniel P Alford, from Boston Medical Center, discusses the importance of clinicians reducing or eliminating opioid use among patients when warranted. “The safe and appropriate prescribing of opioids for chronic pain has become an important national priority. Although core competencies for pain management are being developed, knowing when and how to continue, change, or discontinue opioid therapy must be included in all clinician education efforts. Although Raebel et al are correct in reporting that better pain management strategies are needed, they also may have uncovered an equally important problem—the need to know if, when, and how to safely and effectively taper or discontinue opioid therapy for patients with chronic pain.” 30 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 Changing gut bacteria may lead to obesity treatments Insulin status linked to arterial function following the weight loss Research could lead to a new line of therapeutics to treat obesity and diabetes Study results indicate at least 10% weight loss is needed for comprehensive vascular benefit Gut bacteria A drug that appears to target specific intestinal bacteria in the guts of mice may create a chain reaction that could eventually lead to new treatments for obesity and diabetes in humans, according to a team of researchers from Penn State University and the Nation Cancer Institute. The researchers found mice that were fed a high-fat diet and provided tempol, an anti-oxidant drug that may help protect people from the effects of radiation, were significantly less obese than those that did not receive the drug. “The two interesting findings are that the mice that received tempol didn’t gain as much weight and the tempol somehow impacted the gut microbiome of these mice,” said to Andrew Patterson, assistant professor of molecular toxicology, Penn State. “Eventually, we hope that this can lead to a new line of therapeutics to treat obesity and diabetes.” The researchers, who reported their findings in Nature Communications (Li et al, Microbiome remodelling leads to inhibition of intestinal farnesoid X receptor signalling and decreased obesity. 2013), said that tempol reduces some members of a bacteria, a genus of Lactobacillus, in the guts of mice. When the Lactobacillus levels decreases, a bile acid (tauro-beta-muricholic acid) increases. This inhibits FXR (farnesoid X receptor), which regulates the metabolism of bile acids, fats and glucose in the body. “The study suggests that inhibiting FXR in the intestine might be a potential target for anti-obesity drugs,” said Frank J Gonzalez, laboratory metabolism chief from the National Cancer Institute. The researchers said that tempol may help treat type 2 diabetes symptoms. In addition to lower weight gain, the tempol-treated mice on a high-fat diet had lower blood glucose and insulin levels. “Previously, Dr Mitchell observed a significant difference in weight gain in mice on tempol-containing diet,” said Patterson. “He approached us to help figure out what was going on, and it had been an interesting journey wading through the complexities of the microbiome.” Other studies hinted at the relationship between tempol, the gut microbiome and obesity, but did not O focus on why the drug seemed to control weigh gain, according to Patterson. The researchers said these studies are demonstrating how integrated the 100 trillion microbes that make up the human microbiome are with metabolism and health and how the microbiome may provide more pathways to treating other disorders. “There is a tremendous interest in how the microbiome can be manipulated in a therapeutic way,” said Patterson. “And we need to look at these microbiome management techniques in a good, unbiased way.” In the study, the researchers dissolved the tempol in drinking water or delivered it directly to the mice. Within three weeks, tempol reduced the weight gain for the mice in that group. The mice showed significant reduction in weight gain even after 16 weeks. To further test the role of FXR in obesity, the researchers placed mice that were genetically modified so that they lack FXR on the same high-fat diet. This group was resistant to the effects of tempol and taura-beta-muricholic acid, which further strengthened the importance of FXR in mediating the anti-obesity effect. Gonzalez said that there are indications that FXR plays a similar role in human obesity and diabetes. The researchers must now test the treatments to ensure it is effective in humans, as well as check for any potential side effects, including cancer. bese patients with high insulin levels and had lost considerable weight were the most likely to experience better blood vessel function following the weight loss, According to researchers from Boston University School of Medicine (BUSM) and Boston Medical Center BMC. The findings, which were published online in the Journal of the American College of Cardiology (Bigornia et al. Insulin status and vascular responses to weight loss in obesity. 2013), also suggest that at least 10% weight loss is needed for comprehensive vascular benefit, which may in part explain the negative findings of the recently published Look Ahead study findings. “Our study has shown that insulin status is an important determinant of the positive effect of weight reduction on vascular function with hyperinsulinemic patients deriving the greatest benefit,” said study author Dr Noyan Gokce, associate professor of medicine at BUSM and Director of Echocardiography at BMC. “Reversal of insulin resistance and endothelial dysfunction may represent key therapeutic targets for cardiovascular risk reduction in obesity.” The researchers prospectively followed 208 overweight or obese patients receiving medical/dietary (48 percent) or bariatric surgical (52 percent) weight loss treatment during a period of approximately one year. They measured plasma metabolic parameters and vascular endothelial function using ultrasound at baseline and following weight loss intervention, and stratified analyses by median plasma insulin levels. They found that individuals with higher Noyan Gokce baseline plasma insulin levels (n=99, above median >12uIU/ml), who had greater than 10 percent weight loss had significantly improved brachial artery macro-vascular flow-mediated vasodilation and microvascular reactive hyperemia (p<0.05). In contrast, vascular function did not change significantly in the lower insulin group (n=109, <12uIU/mL) despite similar degree of weight loss. In analyses using a five percent weight loss cut-point, only micro-vascular responses improved in the higher insulin group (p=0.02). “Insulin status is an important determinant of the positive effect of weight reduction on vascular function with hyperinsulinemic patients deriving the greatest benefit,” the researchers concluded. “Integrated improvement in both micro- and macro-vascular function was associated with ≥10% weight loss. Reversal of insulin resistance and endothelial dysfunction may represent key therapeutic targets for cardiovascular risk reduction in obesity.” Insights into the role of the hypothalamus in obesity and T2DM R esearchers from the Joslin Diabetes Center have gained new insights into how obesity and type 2 diabetes can create a stress response in the brain, especially in the hypothalamus which regulates appetite and energy production that may contribute to altering metabolism throughout the body. “This is the first time a study has shown that mitochondrial dysfunction can cause insulin resistance in the hypothalamus and how this can lead to altered metabolism throughout the body,” said Dr Andre Kleinridders, study lead author and an Investigator in the Joslin Section on Integrative Physiology and Metabolism. In the study, reported in the Journal of Clinical Investigation (Kleinridders et al, Leptin regulation of Hsp60 impacts hypothalamic insulin signalling. 2013), the researchers investigated the role of the molecular chaperone heat shock protein 60 (Hsp60) in hypothalamic insulin resistance and mitochondrial dysfunction in type 2 diabetes. Hsp60 is a stress response protein that protects the mitochondria, the power plants of the cell that produce energy. They found that in type 2 diabetes and obesity, the level of Hsp60 goes down, making mitochondria less efficient and leading to insulin resistance in the brain and altered metabolism throughout the body. “These findings link obesity and the fat cell hormone leptin to the process of altered Hsp60 levels in the brain and this appears to start the ball rolling toward altering metabolism in other tissues of the body as well,” said Dr C Ronald Kahn, study senior author and Joslin Chief Academic Officer and Head of the Section on Integrative Physiology and Metabolism, and Mary K Iacocca Professor of Medicine at Harvard Medical School. Although they used mice that were genetically Leptin plays an important role in mitochondrial function and insulin sensitivity in the hypothalamus by regulating HSP60 C Ronald Kahn engineered not to produce Hsp60, it was discovered that they also exhibited mitochondrial dysfunction in the brain which led to insulin resistance in the hypothalamus. “It’s a vicious cycle: people become obese, obesity disturbs the way the hypothalamus responds to stress, which makes people more likely to stay obese and become diabetic,” added Kahn. “The brain not only controls metabolism but the body’s metabolism affects the brain and aspects of brain function.” The investigators also showed that leptin, the hormone produced by fat cells that regulates appetite, is one of the key factors that regulate Hsp60 expression in the hypothalamus and that in obesity this regulation is lost. “Hsp60 deficiency is an acquired defect that can be reversed by weight loss. Also, there is potential to develop drugs that boost Hsp60 levels and improve leptin sensitivity, which could help obese people lose weight. There is definitely strong interest in this area,” explained Kahn. Joslin researchers are also investigating how mitrochondrial dysfunction and insulin resistance affect the brain as it ages. “Mitochondrial dysfunction and insulin resistance in the brain are associated with neurodegenerative diseases. If we could treat mitochondrial dysfunction in the brain, it could increase cognitive performance,” said Kleinridders. “Importantly, type 2 diabetic patients exhibited decreased expression of HSP60 in the brain, indicating that this mechanism is relevant to human disease,” the authors conclude. “These data indicate that leptin plays an important role in mitochondrial function and insulin sensitivity in the hypothalamus by regulating HSP60. Moreover, leptin/insulin crosstalk in the hypothalamus impacts energy homeostasis in obesity and insulinresistant states.” The study was funded by the National Institutes of Health. bariatricnews.net 31 ISSUE 18 | DECEMBER 2013 Obesity damages vagal nerves Study could explain why patients struggle to keep off weight gain T he way the stomach detects and tells our brains how full we are becomes damaged in obese people and does not return to normal once they lose weight, according to new research from the University of Adelaide. Researchers believe this could be a key reason why most people who lose weight on a diet eventually put that weight back on. The results, published in the International Journal of Obesity, (Kentish et al. Altered gastric vagal mechanosensitivity in diet-induced obesity persists on return to normal chow and is accompanied by increased food intake. 2013), show that the nerves in the stomach that signal fullness to the brain appear to be desensitized after long-term consumption of a high-fat diet. An in vitro gastro-oesophageal vagal afferent preparation was used to determine the mechanosensitivity of gastric vagal afferents and the modulatory effect of leptin (0.1–10 nM) was examined. Retrograde tracing and quantitative RT–PCR were used to determine the expression of leptin receptor (LepR) messenger RNA (mRNA) in whole no dose and specific cell bodies traced from the stomach. After 24 weeks, both the HFD and RFD mice had increased body weight, gonadal fat mass, plasma leptin, plasma insulin and daily energy consumption compared with the SLD mice. The HFD and RFD mice had reduced tension receptor mechanosensitivity and leptin further inhibited responses to tension in HFD, RFD but not SLD mice. Mucosal receptors from both the SLD and RFD mice were potentiated by leptin, an effect not seen in HFD mice. LepR expression was unchanged in the whole no dose, but was reduced in the mucosal “The stomach’s nerve response does not return to normal upon return to a normal diet. This means you would need to eat more food before you felt the same degree of fullness as a healthy individual,” says study leader Associate Professor Amanda Page from University of Adelaide’s Nerve-Gut Research Laboratory. “Leptin, known to regulate food intake, can also change the sensitivity of the nerves in the stomach that signal fullness. In normal conditions, leptin acts to stop food intake. However, in the stomach in high-fat diet induced obesity, leptin further desensitizes the nerves that detect fullness. These two mechanisms combined mean that obese people need to eat more to feel full, which in turn continues their cycle of obesity.” In the study, eight-week-old female C57BL/6 mice were either fed a SLD (n=20) or HFD (n=20) for 24 weeks. A third group was fed a HFD for 12 weeks and then a SLD for a further 12 weeks (RFD, n=18). afferents of the HFD and RFD mice. “Disruption of gastric vagal afferent function by HFD-induced obesity is only partially reversible by dietary change,” they conclude. “Which provides a potential mechanism preventing maintenance of weight loss.” “The results have very strong implications for obese people, those trying to lose weight, and those who are trying to maintain their weight loss,” said Page. “Unfortunately, our results show that the nerves in the stomach remain desensitised to fullness after weight loss has been achieved.” “We know that only about 5% of people on diets are able to maintain their weight loss, and that most people who’ve been on a diet put all of that weight back on within two years,” she added. “More research is needed to determine how long the effect lasts, and whether there is any way – chemical or otherwise – to trick the stomach into resetting itself to normal.” Vagus nerve stimulation increases energy expenditure At least part of the effect of VNS intervention on energy expenditure can be explained by BAT activity Short-term interruption of VNS therapy by turning off the VNS for only several hours significantly decreased energy expenditure V agus nerve stimulation (VNS) is accompanied by an increase in whole body energy expenditure and this thermogenesis is related to changes in brown adipose tissue (BAT) activity, according to a study publishing online ‘Vagus Nerve Stimulation Increases Energy Expenditure: Relation to Brown Adipose Tissue Activity’, in the journal PLoS ONE. It is known that human BAT activity is inversely related to obesity and positively related to energy expenditure. BAT is highly innervated and it is suggested the vagus nerve mediates peripheral signals to the central nervous system, there connecting to sympathetic nerves that innervate BAT. VNS is used for refractory epilepsy, but has been reported to reported to generate weight loss. The study researchers from Maastricht University Medical Center, Maastricht, The Netherlands, sought to define the relation between VNS energy expenditure and BAT activation in a patient cohort on chronic stable VNS therapy for refractory epilepsy, and hypothesised that VNS increases energy expenditure by stimulating BAT activity. Study Between January 2011 and June 2012, 15 patients on stable VNS therapy using the Vagus Nerve Stimulation Therapy System (VNS Therapy, Cyberonics) for refractory epilepsy were recruited for the study. Energy expenditure was measured using indirect calorimetry and BAT activity was assessed by means of FDG-PET-CT during actual VNS and when VNS was inactivated. In addition, they compared BAT activity during VNS and during mild cold stimulation. The mild cold intervention served as a control since it is known to activate BAT. Ten patients were measured in thermoneutral (TN) conditions with active (VNS-On) and inactive VNS (VNS-Off) respectively. In addition, five subjects were measured with active VNS in TN conditions (VNS-TN) and during mild cold exposure (VNSCold) respectively. Subjects were measured under fasted conditions (no food intake from 10pm the night before, only water consumption was allowed) from 9am to 2pm under supervision of a specialized research nurse. VNS-On and VNS-Off took place on separate occasions within 14 days. During VNSOff the system was inactivated (output current 0 mA, magnet function 0 mA) at 9:30am prior to the measurements. At the end of the test day (2:00pm) the VNS system was re-activated. During VNS-Cold the settings of the VNS system were not adjusted. VNS-TN and VNS-Cold were also performed within a 14-day period. Body composition (body fat%, fat mass (FM), fat free mass (FFM)) was determined by dual x-ray absorptiometry (DXA, type Discovery A, Hologic, Bedford, MA, USA). Ten male and five female patients with a mean age of 45±10 years and a mean BMI of 25.2±3.5 that were (successfully) treated with VNS for refractory Figure 2: FDG-PET-CT images of intervention group and cold exposed subjects. Pre-VNS treatment body weight and BMI were retraceable for 11 subjects and were not significantly different from weight and BMI during the study (implant weight and BMI; 71.2±12.5, 24.7±3.4, current weight and BMI; 72.9±11.6, 25.2±3.5, p=0.414). The subject characteristics were not different for the On/Off (n = 10) versus the TN/Cold group (n = 5) (Table 1). Figure 1. Basal metabolic rate (BMR) during active and inactive VNS in relation to BAT activity. epilepsy were included (Table 1). VNS implantation was on average 59±19 months (range; 22–89 months) ago and all subjects did not have any recent adjustments in their VNS settings or medication. Outcomes The researchers report that basal metabolic rate (BMR) decreased significantly when VNS was Characteristics Group VNS-On/Off VNS-TN/Cold N 15 10 5 Se± (Male/Female) 10M/5F 4M/6F 1M/4F P-value Age (yrs) 45±10 42±10 49±8 0.203 Height (cms) 170±10.0 168.5±8.4 173±13 0.464 Mass (kg) 73±11.6 70.1±11.7 78.6±10.4 0.194 BMI (kg/m ) 25.2±3.5 24.6±3.0 26.6±4.4 0.316 Fat-free mass (kg) 49.8±9.0 48.8±9.5 51.7±8.5 0.568 Fat mass (kg) 21.9±6.4 20.4±5.3 25.0±8.0 0.199 Body fat (%) 29.5±6.9 28.5±6.4 31.4±8.2 0.459 VNS output current (mA) 1.85±0.55 1.55±0.59 1.65±0.52 0.752 VNS input time (months) 59±19 64±15 50±24 0.185 VNS implant mass (kg) 71.2±12.5 69.8±13.9 72.8±12.0 0.717 VNS implant BMI (kg/m2) 24.7±3.4 24.9±3.1 24.5±4.1 0.861 2 turned off (68.6±7.9 J/s versus 67.2±8.1 J/s, p=0.038, mean change; 2.2%, range; −3.1 to 7.8%, Figure 1). Figure 2 shows representative images of FDG-uptake on PETCT in the studied groups. The mean SUV for BAT showed no statistical difference during VNS (BAT SUVMean; 0.55±0.25 versus 0.67±0.46, p=0.619). In different muscles analysed, the triceps muscle had a significantly increased FDG-uptake when VNS was turned off. However, for all muscles together there was no significant change in activity. P-values shown for unpaired t-tests between VNS-On/Off and VNS-TN/Cold. *P<0.05. doi:10.1371/journal.pone0077221.t002 Table 1. Subject characteristics for all subjects, the intervention group with Vagus Nerve Stimulator (VNS) On and Off (n = 10) and for the group with VNS during thermoneutral (VNS-TN) conditions and cold exposure (VNS-Cold) (n = 5). Figure 3. FDG-PET-CT activity of different tissue types upon VNS intervention. After cold exposure, all subjects showed increased BAT activity (BAT SUVMean; 0.65±0.29 versus 3.40±1.63, p=0.012). Energy expenditure during VNS-On and VNS-Off measurements was not related to BAT activity, activity of other tissue (Muscle, WAT), skin perfusion, core and skin temperatures or any other study parameter in either uni- or multivariate analyses. However, the change in energy expenditure upon VNS intervention (from VNS-On to VNS-Off) was positively correlated to the change in BAT activity (exponential curve fitting, r = 0.935, p<0.001). “This study shows that even short-term interruption of VNS therapy by turning off the VNS for only several hours significantly decreased energy expenditure in a cohort of treatment-stable VNS patients,” the authors note. “Despite the fact that mean BAT activity did not increase upon VNS, the change in BAT activity explained a significant part of the change in energy expenditure. To our opinion, this suggests at least part of the effect of VNS intervention on energy expenditure can be explained by BAT activity.” The study was registered in the Clinical Trial Register under the ClinicalTrials.gov Identifier NCT01491282. 32 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 US survey reveals views on dieting vs. surgery 56.5% of respondents have no idea of their health insurance coverage for weight loss surgery T he results from a US survey that asked participants to share their thoughts on the safety and effectiveness of bariatric surgery compared to the success rate from commercial diet programmes has reported that a majority perceive surgery as either safe or very safe. “Surgical weight loss procedures such as the lap band or the gastric sleeve have often been misconceived as dangerous, and nearly half of the responses admitted to having this opinion,” said Dr Shawn Garber, Founder and President of the New York Bariatric Group, who carried out the survey in partnership with SurveyMonkey. “These survey results will help us educate the American population on the misconceptions of commercial dieting vs. weight loss surgery procedures and stress that weight loss surgery performed by experts in the field Shawn Garber of bariatric surgery is very safe. In fact, there are fewer risks involved with surgical weight loss procedures as there are with staying obese and suffering from multiple life threatening health issues.” The survey entitled “Commercial Dieting vs. Surgery: Who wins the Weight Loss battle?” asked over 2,000 men and women across the US to share their perspective towards commercial weight loss programs vs. surgical weight loss procedures. Key results of the survey revealed: n 61.2% of people who took the survey were either overweight or obese and would likely qualify for weight loss surgery n 58% of people said they have considered some sort of weight loss, yet, 46% of people don’t have an opinion on weight-loss programs n 6% of people said they did not have an opinion on weight loss programmes, 23.5% of people chose Weight Watchers, while only 6.3% would consider weight loss surgery n When participants were asked how much weight loss the average person maintained two years after completing a commercial weight loss programme, more than half said 5-15lbs n When they were asked how much weight loss the average person maintained two years after receiving weight loss surgery, 57.6% said between 30-80lbs n 41.5% of people perceives weight- loss surgery as the best solution for those who have a serious weightrelated issue, while 35.5% of people believe that people should be able to diet and exercise long term, and not resort to surgery n 52.5% of respondents perceive weight loss surgery as either safe or very safe, while 47.5% still believe it’s not very safe or extremely dangerous n 56.5% of respondents have no idea of their health insurance coverage for weight loss surgery and 25.7% would assume that their health insurance does not cover weight loss surgery “One of the most interesting results we found was that 56.5% of respondents have no idea of their health insurance coverage. As obesity is becoming a serious, common health threat and is now being formally recognized as a disease, more insurance companies are covering bariatric procedures because of their effectiveness. That said, insurance companies should be doing more to make their members aware of the coverage available for bariatric surgery,” said Garber. “I also find it interesting that 41.5% of people perceive weight-loss surgery as the best solution for those who have a serious weight-related issue, while 35.5% of people believe that people should be able to diet and exercise long-term, and not resort to surgery. This proves that there is a common belief that diets work long-term, when in fact, 95% of the time, they do not work for those who suffer from obesity.” The New York Bariatric Group will be executing a tailored and more focused marketing initiative to address some of the concerns and findings reported in the survey. Perceptions of access and waiting for surgery T hree important areas of perceived inequity related to waiting for bariatric surgery: socioeconomic inequity, regional inequity, and inequity related to waitlist prioritisation Patients’ perceptions of accessing and waiting for bariatric surgery are shaped by perceived and experienced inequities within the healthcare system, according to a research paper titled ‘Patients’ perceptions of waiting for bariatric surgery: a qualitative study’, published in the International Journal for Equity in Health (Gregory et al. 2013;12:86). The paper calls for a system to address these socioeconomic, regional and waitlist inequities. Specifically, it states that ‘equitable access to treatment should be a health system priority’ and that ‘supports and resources are required to ensure the waiting experience is as positive as possible’. Researchers from Memorial University, Newfoundland and Labrador, Canada, wanted to explore patients’ perceptions of waiting for bariatric surgery, the meaning and experience of waiting, the psychosocial and behavioural impact of waiting for treatment and identify healthcare provider and health system supportive measures that could potentially improve the waiting experience. The primary objective was to develop an understanding of the pre-surgical experience of patients that choose to undergo a surgical weight loss intervention for the management of morbid/clinical obesity after being placed on a waitlist for bariatric surgery. The meaning of bariatric surgery and the psychosocial impact of waiting for this form of treatment for individuals must be understood if multidisciplinary bariatric clinical team providers are to act as facilitators in promoting satisfaction with care and quality care outcomes. “In a publicly funded healthcare system that promotes universal care, this research is highly relevant for policy makers who want to ensure that patients have equal access to treatment based on need,” they write. “In this paper we focus on patients’ experiences while waiting, particularly the emotional consequences of waiting, and the insights that these experiences bring to a discussion of equity, including socioeconomic, regional, and waitlist prioritization inequities. We include participants’ recommendations on how the waiting experience can be made more positive.” Study Twenty-one women and six men engaged in in-depth interviews between June 2011 and April 2012. The data were subjected to reanalysis to identify perceived healthcare provider and health system barriers to accessing bariatric surgery. The age of participants ranged from 26 to 64 years, with an average age of 45.3 years. Six participants (22%) had a high school education or less, 15 (56%) had some post-secondary education and six (22%) had a university degree. The majority of participants were Caucasian (26, or 96%, while one identified as aboriginal), married or living with a common-law partner (18, or 66%), had children (21, or 78%), and were working full-time (16, or 59%). Approximately 85% of the sample reported three or more co-morbid conditions. BMI data were not collected during the interview since all participants met the Canadian consensus guidelines for eligibility for criteria for bariatric surgery, were approved for bariatric surgery by the bariatric surgeon, and at the time of the initial interview, were waiting for bariatric surgery. Participants’ self-identified waiting periods at the time of the interview varied widely, with one third waiting for less than six months, and half waiting for more than five years. Outcomes The researchers reported that the participants highlighted three important areas of perceived inequity related to waiting for bariatric surgery: socioeconomic inequity, regional inequity, and inequity related to waitlist prioritisation. Health system level factors including the lack of availability of bariatric surgical services and individual level factors related to the financial burden associated with accessibility of the existing service were viewed as obstacles or barriers. They also said that the longer the waiting period was for surgery, the more difficult it was for participants to stay motivated and engaged in maintaining their current health as they prepared for surgery The researchers also comment on the regional and provincial variations in capacity for bariatric surgery. It is estimated that demand for bariatric surgery exceeds potential capacity by over 600-fold. In addition, they note that six of the thirteen provinces and territories have no bariatric surgery programme, so patients from these regions must travel to other provinces for bariatric surgery. However, many of these provinces do not accept non-residents due to the length of their wait lists. Conclusion “This study also brings attention to the need for a concerted effort to address the growing dissatisfaction of patients accessing bariatric surgery and the perceived unacceptable wait times that arise once the patient is deemed eligible to undergo the surgery,” the authors conclude. “Recommendations on how to improve the waiting experience included periodic updates from the surgeon’s office about their position on the wait list; a counsellor who specialises in helping people going through this surgery, dietician support and further information on what to expect after surgery, among others.” Genetic mutations cause severe obesity A novel genetic cause of severe obesity which, although relatively rare, demonstrates for the first time that genes can reduce basal metabolic rate, researchers from the University of Cambridge will report in a paper. ‘KSR2 Mutations are Associated with Obesity, Insulin Resistance and Impaired Cellular Fuel Oxidation’, published in journal Cell. Previous studies (performed by David Powell and colleagues at Lexicon Pharmaceuticals in Texas) demonstrated that when the gene KSR2 (Kinase Suppressor of Ras 2) was deleted in mice, the animals became severely obese. Subsequently, Professor Sadaf Farooqi from the University of Cambridge’s Wellcome Trust-MRC Institute of Metabolic Science decided to explore whether KSR2 mutations might also lead to obesity in humans. “Up until now, the genes we have identified that control body weight have largely affected appetite,” said Professor Farooqi. “However, KSR2 is different in that it also plays a role in regulating how energy is used in the body. In the future, modulation of KSR2 may represent a useful therapeutic strategy for obesity and type 2 diabetes.” In collaboration with Dr Ines Barroso’s team at the Wellcome Trust Sanger Institute, the researchers sequenced the DNA from over 2,000 severely obese patients and identified multiple mutations in the KSR2 gene. KSR2 belongs to a group of proteins called scaffolding proteins which play a critical role in ensuring that signals from hormones such as insulin are correctly processed by cells in the body to regulate how cells grow, divide and use energy. To investigate how KSR2 mutations might lead to obesity, Professor Farooqi’s team performed a series of experiments which showed that many of the mutations disrupt these cellular signals and, importantly, reduce the ability of cells to use glucose and fatty acids. Patients who had the mutations in KSR2 had an increased drive to eat in childhood, but also a reduced metabolic rate, indicating that they have a reduced ability to use up all the energy that they consume. A slow metabolic rate can be found in people with an underactive thyroid gland, but in these patients thyroid blood tests were in the normal range – eliminating this as a possible explanation for their low metabolic rate. The findings in this study provide the first evidence that defects in a particular gene, KSR2, can affect a person’s metabolic rate and how their bodies processed calories. Changes in diet and levels of physical activity underlie the recent increase in obesity in the UK and worldwide. However, there is a lot of variation in how much weight people gain. This variation between people is largely influenced by genetic factors, and many of the genes involved act in the brain. The discovery of a new obesity gene, KSR2, adds another level of complexity to the body’s mechanisms for regulating weight. The Cambridge team is continuing to study the genetic factors influencing obesity, findings which they hope to translate into beneficial therapies in the future. “Our findings provide the first evidence that defects in a particular gene, KSR2, may affect a person’s metabolic rate and how their bodies process calories,” said Barroso. This work was supported by the Wellcome Trust, Medical Research Council, NIHR Cambridge Biomedical Research Centre, and European Research Council. bariatricnews.net 33 ISSUE 18 | DECEMBER 2013 Study survey: Choice and biology explain obesity Over 90% of participants attributed obesity to overeating and a majority of participants (57%) agreed that there is a medical cause to obesity Psychotherapy or counselling was listed by 44% of participants as the most effective treatment for a food addiction, followed by dietary changes (22%) S trong public acceptance of neurobiological explanations of overeating and obesity can co-exist with the view that personal choice is the predominant cause of obesity, according to researcher Public Views on Food Addiction and Obesity: Implications for Policy and Treatment., published online in the journal Plos One. The study investigators, from the University of Queensland, Brisbane, Australia, believes the study shows that “as the concept of food addiction is developed, its advocates need to pay greater attention to its effects on stigma, treatment and policy and to assessing whether its net impact on public health is likely to be harmful or beneficial”. The authors undertook the study to examine the public’s acceptance of the concept of food addiction as an explanation of overeating, and assess its effects upon their attitudes toward obese persons and the treatment of obesity. It has been well documented that patterns of eating in some individuals resemble the behaviour of drug-addicted individuals and many compulsive eaters and obese individuals demonstrate substance dependence when these are applied to the consumption of specific foods. Study They conducted an online survey of 479 adults from the US (n=215) and Australia (n=264), primarily to identify any cross-cultural differences between public attitudes in two developed Westernised countries that have high rates of obesity. They were asked three questions to assess their understanding of the causes of obesity and its risk fac- tors. The first question was a multiple-choice question to assess what participants believed to be the main cause of obesity. “Biological causes” and “genetics or family history” were combined during analysis as the two represent causes external to personal control. Outcomes A total of 610 individuals began the online survey, with 79% completing the study without error (n=479), yielding 215 US and 264 Australian participants. One third of participants said personal choice (32%) was the main cause of obesity, 27% ascribed it either to biological and genetic causes, and 23% chose the environment. A sizeable minority (18%) chose “other”, with most of these participants indicating that obesity was caused by a combination of factors. Over 90% of participants attributed obesity to overeating and a majority of participants (57%) agreed that there is a medical cause to obesity, although over a quarter were unsure. Views on the causes of obesity did not differ significantly by country of residence. Almost three quarters (72%) of participants believed that an addiction to certain foods caused obesity, just over half (54%) agreed that obesity should be treated as an addiction, and 64% were prepared to classify obesity as an eating disorder. Most (86%) participants thought that certain foods are addictive (79% in the case of sugar) and 80% believed that some foods could be as addictive as alcohol, nicotine and cocaine. With regards to region, there were no significant differences in the participants belief that obesity was caused by a food addiction (69% v. 74%) or who considered obesity to be an eating disorder (60% v. 67%). A significantly lower proportion of US (73%) than Australian (86%) participants agreed that obesity was harmful to society (OR = 0.49, 95% CI 0.29–0.84), and that obesity should be treated as an addiction: 47% US vs. 59% Australia (OR = 0.59, 95% CI 0.38–0.92). Two thirds (69%) of participants were aware of research suggesting that foods could be addictive in the sense of producing changes in the brain similar to drugs of abuse. 81% of all participants supported this view. Participants from the US and Australia did not differ in their awareness and acceptance of neuroscientific evidence for food addiction. Treatment of obesity Two-thirds believed that diet was the most common treatment of obesity but only one quarter believed it to be the most effective. Just over a quarter of participants (27%) thought that exercise was the most effective treatment of obesity. Half of the participants thought that prescription drugs were the least effective treatment of obesity, followed by surgery (16%). Participants’ responses varied only slightly by country of residence: 31% of US participants believed that exercise was most effective whereas 30% of Australians thought that diet was most effective. Psychotherapy or counselling was listed by 44% of participants as the most effective treatment for a food addiction, followed by dietary changes (22%). Educational and support groups were thought by 33% to be the most effective policy to address food addiction. Restrictions on advertising had the least support (5%). Over half of the participants (57%) disagreed that imposing a tax on certain foods would lower rates of obesity and 49% did not think that such a tax would be helpful to society. There were no significant differences between US and Australian participants on the most effective treatment and policy changes needed to reduce an addiction to certain foods. While the participants were aware of and supported the concept of food addiction, this did not change their attitudes toward obese individuals or the most effective method of treating obesity in 75% and 53% of participants, respectively. Obese participants were less than a third as likely as their normal and overweight counterparts to view obesity as harmful to society (OR = 0.30, 95% CI 0.16–0.54). Obese participants were also less supportive of imposing a tax on foods than normal and overweight participants (OR = 0.52, 95% CI 0.21–0.58). Participants’ awareness of certain foods’ addictive potential and their agreement with this did not significantly differ by BMI. Obese individuals were twice as likely to report a change in their views about obese individuals (p<0.05) and obesity treatment (p<0.001) after hearing about neuroscientific explanations of addiction than were normal weight participants. Obese individuals believed that Sarah had less control over her eating and weight (OR = 0.36, 95% CI 0.21–0.58) and was less responsible for becoming obese (OR = 0.34, 95% CI 0.21–0.55) and losing weight (OR = 0.32, 95% CI 0.18–0.55) than normal and overweight participants. Perceived personal responsibility for weight decreased as BMI increased. “Our findings indicate that while participants were willing to accept that some foods can be addictive, this did not entail support for medical treatments of obesity or change the strong emphasis placed on obese persons’ responsibility for their weight,” they state. “It may also reflect the view that medical treatments of obesity are of limited effectiveness. Very few thought that medical interventions such as prescription drugs (1%), surgery (8%) or psychotherapy (11%) would be effective. Diet was seen as the most common treatment of obesity by two-thirds of respondents but only a quarter of respondents believed it to be effective.” With regards to country, Australian participants were more aware of the harmful effects of obesity on society and a significantly larger proportion of Australians thought that obesity should be treated as an addiction. “There was substantial support for the idea of food addiction, particularly among obese participants,” they add. “Despite the strong support for seeing obesity as a form of addiction, respondents still saw obesity as primarily the result of personal choices and emphasised the need for individuals to take responsibility for their eating.” Conclusion “In our sample, obese participants were more likely to support the view that obesity represents an addiction to certain foods,” the authors conclude. “The apparent failure of neurobiological explanations of overeating and obesity to alter public views toward obese individuals and the treatment of obesity suggests that these explanations have not yet had the beneficial impacts assumed by their advocates.” New drug regimen reduces PONV B ariatric surgery patients avoided postoperative nausea and vomiting (PONV) with the addition of a second drug to the standard treatment given during surgery, according to a study entitled ‘Aprepitant In Combination With Ondansetron Reduces Postoperative Vomiting In Bariatric Surgery Patients’ presented at the Anesthesiology 2013 annual meeting. “Nausea and vomiting are some of the most common post-op complications for all patients who have general anaesthesia,” said Dr Ashish C Sinha, vice chair of anesthesiology and perioperative medicine at Drexel University College of Medicine, Philadelphia. “However after weight-loss surgery, the consequences of vomiting can be very serious. During this kind of surgery, the stomach is transformed to a small, one-ounce sac. Vomiting risks rupturing the fresh incision as the contents of the stomach try to violently exit the narrow, freshly created stomach pouch. Reducing this risk would mean more comfortable patients as well as safer surgery and anaesthesia.” Morbidly obese patients undergoing general anesthesia for bariatric procedures can often experience PONV for up to 48 hours. Even with the use of 5HT3 receptor antagonists for antiemetic prophylaxis, 30-40% of patients continue to experience PONV. Aprepitant is a newer substance P antagonist that mediates its effects by blocking the neurokinin-1 receptor, and is useful in the prophylaxis of both acute and delayed onset PONV. A total of 124 patients were enrolled in this randomised, double blind, placebo controlled trial from 2010 to 2012. On the day of surgery, patients were randomised into one of two arms: 40mg oral aprepitant (n=64), or a placebo (n=60). Aprepitant or a placebo was given within one hour of anticipated induction of anaesthesia with a small sip of water. All patients received 4 mg intravenous (IV) ondansetron in the operating room before induction. Patients that experienced intractable nausea that lasted at least 15 minutes, or those who requested antiemetic medication were given rescue therapy. The initial drug of choice was 4mg IV ondansetron, followed by additional antiemetic therapy at the anesthesiologist’s discretion. Nausea was assessed using a ten-point scale at the following postoperative intervals: 30 minutes, one hour, two hours, six hours, 24 hours, 48 hours, and 72 hours. The incidence of vomiting was recorded. Results The results showed that the occurrence of vomiting was significantly lower in the treatment arm when compared to the placebo (3% versus 15%, p=0.02). However, the addition of aprepitant was not effective in reducing the rate of nausea when compared to ondansetron alone (36% versus 42%). The researchers said that this data supports the use of this combination therapy as an effective prophylactic antiemetic regimen in bariatric surgery patients. “This multi-drug therapy can benefit patients at higher risk for PONV,” added Sinha. “There are multiple receptors in the brain stem that trigger vomiting; if we use the combination therapy, we can increase the number of receptors blocked and lower the incidence of vomiting.” 34 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 Country news British Columbia to increase number of bariatric procedures B ritish Columbia is looking to significantly boost the number of weight-loss surgeries performed in hospitals, according to a report in the Times Colonist. British Columbia hospitals should be performing about 1,000 bariatric surgeries every year, said Dr Mehran Anvar, president of the Canadian Association of Bariatric Physicians and Surgeons. The province currently performs about 260 each year in two centres: 120 at Victoria’s Royal Jubilee Hospital and 140 at Richmond General Hospital. The province hopes to follow in the footsteps of Ontario, which will fund 3,300 weight-loss surgeries in 2013-14.One Canadian study found weight-loss surgery paid for itself within 3.5 years and saved C$5,700 per patient after five years, he said. Increasing the number of surgeries in Ontario will save the province up to C$10,000 extra per surgery it was paying for as many as 1,700 procedures to be done every year in the United States. In contrast, British Columbia sent ten patients to Seattle in 2010. “It is money well spent,” said Anvari, who is also CEO of the Centre for Surgical Invention and Innovation, affiliated with McMaster University. “Not only does the surgery restore patients’ health, it also restores the productivity lost by their inability to work due to obesity.” With one-time provincial funding, British Columbia has been able to reduce the number of people on the waiting-list for surgery to 196 this year from 462 in 2011. “This is obviously a very under-serviced group of patients across the country, not just in British Columbia,” Anvari said. His goal as the president of the national bariatric surgery association is to help all provinces provide programs similar to Ontario’s. Oversight of procedures In addition, the British Columbia Ministry of Health has requested more oversight of weightloss surgery provided to hundreds of morbidly obese patients at private medical clinics. The request was made following a recent report from health officials that “laparoscopic banding is not as effective over the long-term as other forms of bariatric surgery, according to international sci- entific studies.” Subsequently, the British Columbia College of Physicians and Surgeons has been asked to take steps to ensure the quality of surgeries after laparoscopic banding. Dr Mehran Anvari, president of the Canadian Association of Bariatric Physicians and Surgeons, said it’s up to each college to regulate private clinics in their provinces. “Banding is a recognised technique, although there is increasing evidence that patients that have banding do have higher reoperation rates and less effectiveness.” Laparoscopic banding was approved by the college in September 2009, since then some 318 procedures have taken place in private clinics. “This is the first time a request [for oversight] such as this has been made,” said Susan Prins, spokeswoman for the British Columbia College of Physicians and Surgeons. Prins said the ministry sometimes requests data from the regulatory body for British Columbia doctors, however in this case, the college has been asked to review its accreditation of laparoscopic banding procedures in private clinics and “ensure it monitors standards and outcomes for laparoscopic banding.” “The reality in British Columbia is that morbidly obese patients cannot access appropriate advanced surgery for obesity in the public facilities, so their only option is gastric banding at the private facility’s cost,” said Prins. The ministry’s one-time funding of C$2 million has reduced the waiting list for bariatric surgery from 462 in 2011 to 196. An additional two surgeons at Richmond General Hospital have begun performing the surgery. British Columbia’s Health Services Authority is co-ordinating with the Vancouver Island Health Authority and Vancouver Coastal Health, where Richmond General Hospital now has two surgeons providing weight-loss surgery, to create a standard for services, referrals and care. “An implementation plan as well as plans for the 2013-14 fiscal year is expected to be finalised this fall,” the Health Ministry said in a statement to the Times Colonist. The number of procedures performed in the province has increased considerably in the last few years, in 2010 only 52 weight-loss surgeries were performed in British Columbia. CDC update: More than 78 million US adults are obese T he prevalence of obesity among adults in the US is still more than one-third (78 million adults) of the population, according to the latest data published by the Centers for Disease Control and Prevention (CDC). The data shows that 34.9% of adults were obese in 2011–2012 (Figure 1) and the obesity rate was higher among middle-aged adults (39.5%) than among younger (30.3%) or older (35.4%) adults. “It’s kind of a confirmation of what we saw last time, that the prevalence of obesity in adults may be levelling off,” said co-author Cynthia Ogden, a senior epidemiologist with the CDC’s National Center for Health Statistics. “From 2003-04 through 2011-12, there have been no statistical changes in obesity in adults.” Published by the National Center for Health Statistics (NCHS Data Brief, No 131, October 2013), the update also reveals that the overall prevalence of obesity did not differ between men and women in 2011–2012. However, among non-Hispanic black adults, 56.6% of women were obese compared with 37.1% of men (Figure 2). The prevalence of obesity was also higher among non-Hispanic black (47.8%), Hispanic (42.5%), and non-Hispanic white (32.6%) adults than among non-Hispanic Asian adults (10.8%). “The goal of the human species since we evolved has been to have enough to eat, and we’ve gotten there. Unfortunately, it’s so plentiful we can take in more than we need,” said Matt Petersen, managing director of medical information and professional engagement for the American Diabetes Association. “The human body and brain is wired to take in more than a sufficient number of calories, and that’s a hard thing to change. We’re talking about really powerful aspects of our metabolism.” The US economy loses an estimated US$270 billion a year due to healthcare costs and loss of productivity associated with obesity and overweight, according to a 2011 report produced by the Society of Actuaries. “It just shows that we still have a lot of work to do,” said Rachel Johnson, a professor of nutrition at the University of Vermont and a spokeswoman for the American Heart Association. “We’re making a little bit of progress in childhood obesity, some very small declines, but it at least feels like we’re making some headway there. There are some small pockets in a few cities or states where we’ve seen a modest decline in childhood Figure 1: Age-adjusted prevalence of obesity, by sex, among adults aged 20 and over: United States, 2009–2010 and 2011–2012. effectiveness or lifestyle modifications like diets and physical activity plans and finding out how well kids will stick to them. Nationally, childhood obesity rates seem to be levelling or falling slightly. In August 2013, researchers from the Centers for Disease Control and Prevention (CDC) reported drops in obesity rates among pres-choolers living in 18 states and the US Virgin Islands. Figure 2. Age-adjusted prevalence of obesity, by sex However, Kelly warned that while the nationand race and Hispanic origin, among adults aged 20 al problem may be levelling, severe obesity rates and over: United States, 2011–2012 among children are on the rise. 1. Significant difference from non-Hispanic Asian. 2. Significant difference from non-Hispanic white. 3. Significant difference from women. 4 Significant difference from Hispanic. NOTE: Estimates are age-adjusted by the direct method to the 2000 US census population using the age groups 20–39, 40–59, and 60 and over. SOURCE: CDC/NCHS, National Health and Nutrition Examination Survey, 2009–2010 and 2011–2012. obesity, due to very aggressive interventions.” “My view is that we have to start making some pretty major environmental changes so we make the healthy choice the easy choice,” she said. “We’ve got to move beyond the idea that it’s all about personal choice and education, and we need to start making these environmental changes.” “The beginning of this century has got to be about behavior change,” Johnson added. “How do we help people make healthy choices, and how do we create an environment that’s conducive to good health?” Childhood obesity Meanwhile, researchers reviewing data on US children have determined that five percent have severe obesity, according to a scientific statement published in the AHA’s journal Circulation (Researchers reviewing data on US children have determined that five percent have severe obesity, according to a scientific statement published in the AHA’s journal Circulation (Severe obesity in children and adolescents: identification, associated health risks, and treatment approaches: a scientific statement from the american heart association.2013:128(15):1689-712). The policy statement, which defines severe childhood obesity for other doctors, states that children are often assessed based on how their body mass compares to that of their age group. They are considered overweight if their BMI falls into the 85th to less than 95th percentile of others of their age and gender. Obesity is diagnosed if a child has a BMI equal or greater to 95 percent of their peers. Overall, one-third of US children are considered obese or overweight. “Severe obesity in young people has grave health consequences,” said study author Dr Aaron Kelly, a researcher at the University of Minnesota Medical School in Minneapolis. “It’s a much more serious childhood disease than obesity.” The AHA’s scientific statement reveals a new definition for those who are severely obese: having a BMI at least 20 percent higher than the 95th percentile for their age and gender, or a BMI of 35 or higher. That means a seven-year-old girl of average height that weighs 75lbs or a 13-year-old boy who weighs 160 points would be considered severely obese. Statement The statement calls for innovative approaches to fill the gap between early interventions lifestyle changes and medication, and the final intervention – weight loss surgery. “Bariatric surgery has generally been effective in reducing body mass index and improving cardiovascular and metabolic risk factors; however, reports of long-term outcomes are few, many youth with severe obesity do not qualify for surgery, and access is limited by lack of insurance coverage,” the authors write. He also noted that severely obese children face a significant risk of developing type 2 diabetes, high blood pressure, high cholesterol levels, and cardiovascular issues. “Even highly intensive lifestyle interventions generally have left subjects still markedly obese, albeit with modestly improved cardiovascular and metabolic profiles,” they note. Specific suggestions from the statement’s authors include conducting new studies on the Recommendations The American Heart Association recommends the following tips to healthcare professionals to address the obesity problem: n More research into the effects and safety of bariatric surgery. n Attention into the effectiveness of lifestyle modification interventions such as adhering to a diet and physical fitness. n Research into other useful weight loss tools including drugs and medical devices. n The recognition of severe obesity as a chronic disease that requires care and management. Cardiologist, Dr Valentin Fuster, director of Mount Sinai Heart at The Mount Sinai Medical Center in New York City, said weight management is difficult for children because due to hormones they tend to want to eat more, while some have such low self-esteem from their lifelong struggles with weight, they simply give up trying. He explained that it was too simple to argue kids are eating too much and that early interventions should target anxiety, family or genetic-related issues that may be contributing to obesity at such a young age. “This is why it’s so important to know the reasons for why you’re obese,” he added. “All society should be aware that this is a huge problem, leading to an epidemic of cardiovascular diseases.” “Alternative approaches are needed for youth who medically qualify for bariatric surgery but are not interested in this option, for youth who lack the family support or emotional maturity for the surgery and resulting change in food intake, and for children too young for surgery but with severe obesity and severe comorbidities,” they concluded. “The task ahead will be arduous and complicated, but the high prevalence and serious consequences of severe obesity require us to commit time, intellectual capital, and financial resources to address it.” bariatricnews.net 35 ISSUE 18 | DECEMBER 2013 Country news Australian coalition to provide more funding for bariatric surgery? Calls for more funding to go into prevention not treatment The newly-elected coalition government in Australia could provide more public funding for weight loss surgery to tackle Australia’s growing obesity problems, according to comments made by the coalition’s health spokesman, Peter Dutton, during an election health debate before the Coalition was elected at the weekend. During the debate with the previous Health Minister, Tanya Plibersek, Dutton said that he plans to cut health bureaucracies like the Australian National Preventative Health agency. More than half the adult population is now overweight or obese and Dutton said that he is keen to use bariatric surgery to help tackle the problem. “And in terms of bariatric surgery, yes, we’re open to some discussions with the states predominately about investment in that space. I’d be happy to look at that,” he said. More than 17,000 Australians a year undergo bariatric surgery and the National Health and Medical Research Council now recommends if for those with a BMI over 30 and poorly controlled diabetes. However, just six per cent of the surgery is funded in public hospitals and it costs up to AUS$15,000 in a private hospital. The coalition has also stated that it may cut the budgets of the Australian National Preventive Health Agency to help fund its election commitments. “We want to look at ways in which we can streamline some of that which may well result in some of the agencies folding into those with a similar task, there will be no changes to the programmes they are offering,” said Dutton. Dr Paul Burton, a senior research fellow at the Monash University Centre for Obesity Research and Education, said that Australia needs more public funding because bariatric surgery works better than other weight loss techniques. “At present, people may miss out due to the costs of the surgery,” he said. “It saves money by remitting disease, reducing hospital admissions and improving people’s capacity for employment.” He added that the initial public expense would be counter-balanced with the reduction in on-going health costs. “But it’s only beneficial if done well, in combination with high quality patient follow up. If either of these are deficient, outcomes are not optimal.” However, Dr Debra Hector, a senior research fellow in prevention research collaboration at Sydney University, said she would prefer to see money invested in a more holistic approach. “Government should be funding surgery as we have a lot of very obese people who need the surgery, however focusing only on that one solution is ridiculous,” she said. “Surgery is a treatment –– it’s not preventing people getting to that place in the first place.” Hector said the government needs to make healthy living more accessible if we want to deal with the cause of obesity, not just the symptoms. “We need to make it easier for people to be more healthy and live more actively,” she said. “Things like more open spaces, more green spaces and more active travel to enable people to walk and bike to work. We need to make fruit and vegetables more affordable and available, and put a tax on soft drinks and confectionary. Soft drink is just not needed, especially when you get two litre bottles for AUS$1, milk is even more expensive.” 10.8 million Australians are overweight or obese The propsed increase in funding comes as new data showed that more than six out of ten Australian adults are too fat to be healthy, according to data that shows 10.8 million are overweight or obese. The new report. National Health Performance Authority 2013, Healthy Communities: Overweight and obesity rates across Australia, 2011–12 (In Focus), also shows that obesity in the country has increased from 11% in 1989 to 28 per cent in 2011-12. It is thought that this is the first report to show that the percentage of adults who were obese varied threefold across local areas, from 14% in Sydney North Shore and Beaches to 41% in Loddon-Mallee-Murray. The percentage of adults who were overweight or obese increased with geographic remoteness and lower socioeconomic status. However, 54% of adults in the wealthiest urban areas were overweight or obese, and almost two in ten (19%) were obese. The area of greatest concern is western New South Wales, where 79% of people are overweight or obese. The second is Queensland’s Townsville-Mackay, followed by country South Australia, Victoria’s Gippsland and Western Australia’s Goldfields-Midwest, with approximately three quarters of the population overweight. Eastern Sydney is the slimmest area, with 49% of people overweight or obese, while Sydney’s north shore and northern beaches and inner north-west Melbourne follow at 50%. “Using our local-level analysis, clinicians and health managers can now better target and drive health system improvements specific to their local community’s needs,” said Performance Authority CEO Dr Diane Watson. “Rates of adult obesity have been rising very rapidly over time, while smoking rates have been falling nationally. The health and economic impact of obesity and smoking can be extremely serious.” Drink tax could reduce UK adult obesity by 180,000 Tax could cut drinks purchases by 15% and lead to a reduced energy intake of 28 calories per person per week A 20% tax on sugar-sweetened drinks would reduce the number of UK adults who are obese by 180,000 (1.3%) and who are overweight by 285,000 (0.9%), according to a study (Briggs et al. Overall and income specific effect on prevalence of overweight and obesity of 20% sugar-sweetened drink tax in UK: econometric and comparative risk assessment modelling), published in BMJ. A typical sugary drink contains six to 15 teaspoons of sugar, a teaspoon is equivalent to 4g of sugar or 16 calories. The researchers estimated that such a tax could cut drinks purchases by 15% and lead to a reduced energy intake of 28 calories per person per week. “Sugar-sweetened drinks are known to be bad for health and our research indicates that a 20% tax could result in a meaningful reduction in the number of obese adults in the UK,” said Dr Adam Briggs, lead study author from the Nuffield Department of Population Health at Oxford University. “Such a tax is not going to solve obesity by itself, but we have shown it could be an effective public health measure and should be considered alongside other measures to tackle obesity in the UK.” Researchers at the universities of Oxford and Reading set out to estimate the effect of a 20% tax on sugar-sweetened drinks on obesity in the UK, and to understand the health effect on different income groups. Using a series of statistical models based on available data the researchers estimated that a 20% tax (which would raise the cost of a 70p can to 84p) would decrease sugary drink consumption by about 15%. This, they estimate, would lead to a 180,000 (1.3%) reduction in the number of obese adults in the UK, and a 285,000 (0.9%) reduction in the number of overweight and obese adults. The health gains would be similar across all income groups, but would decline with age. Although the study’s authors claim that this is a relatively modest effect, people aged 16-29 years as the major consumers of sugar sweetened drinks, would be impacted the most. “There’s ample evidence to suggest that taxing soft drinks won’t curb obesity, not least because its causes are far more complex than this simplistic approach implies,” said Gavin Partington, director general of the British Soft Drinks Association. “Indeed, the latest official guidance from the National Institute for Health and Care Excellence points to the need to look at overall diet and lifestyle. Trying to blame one set of products is misguided, particularly when they comprise a mere 2% of calories in the average diet.” The tax would be expected to raise £276m (€326m; $442m) annually (around 8p per person per week) and would reduce consumption of sugar sweetened drinks by around 15%. This revenue, say the authors, “could be used to increase NHS funding during a period of budget restrictions or to subsidise foods with health benefits, such as fruit and vegetables.” They conclude that taxation of sugar sweetened drinks “is a promising population measure to target population obesity, particularly among younger adults.” But they stress that it “should not be seen as a panacea” and say further work is needed to clarify the level (and patterns) of sugar sweetened drink consumption in the UK. “Most nutritionists agree it would be better to drink water than sugar-sweetened beverages,” said Tom Sanders, professor of nutrition and dietetics at King’s College London, UK. “However, many consumers like sweet drinks and if they could not afford to buy sugary fizzy drinks they can always revert to drinking tea with added sugar as in the past. The cost of sugar-sweetened beverages is currently so low that any price increase would be so marginal that it would be unlikely to affect intake.” It is believed that obesity-related complaints cost the NHS £5 billion a year. American Heart Association The American Heart Association has issued the following statemnet, supporting the outcomes of the study: “The American Heart Association supports a multi-pronged approach to address obesity across our nation. We must make it easier for Americans to choose affordable nutritious foods and beverages by making them more accessible. This includes creating and implementing new policies that provide healthier options as well as efforts to educate all Americans on nutrition. The American Heart Association advocates that communities should increase the availability of healthy drinks and decrease the availability of unhealthy drinks. The economic model used for this study from the British Medical Journal, and the existing evidence, provides policymakers a compelling case to enact targeted sugar-sweetened beverage taxes of at least one penny per ounce. This will help further evaluate the impact of price on the consumption of sugary drinks. Many published economic models have demonstrated the potential benefit of a penny-per-ounce tax on sugary drinks. Once states and cities enact such policies, we need thorough evaluation to see the real world impact on consumer purchasing, consumption of sugary drinks, industry response and health outcomes. Mexico’s effort provides an excellent starting point, but we need U.S. states and communities to enact the tax as well. We agree with the new study’s conclusion that calls for more substantial beverage taxes so that real world evidence can demonstrate their effectiveness at curbing sugary drink consumption and improving the health of Americans of all ages. It is well-established that sugar-sweetened beverages are the number one source of added sugars in the American diet. A 12-ounce can of regular soda contains about 130 calories and 8 teaspoons of sugar. Consumption of sugary drinks has increased 500 percent in the past 50 years and now is the single largest category of caloric intake in children, surpassing milk a decade ago. Children take in 10 to 15 percent of their total daily calories from sugary drinks. We recommend low- and no calorie beverages such as water, unsweetened tea, diet soft drinks, and fat-free or low-fat milk as better choices than full-calorie soft drinks. In addition, Americans should try to limit the amount of added sugars in all the foods they eat. We further advocate that state and local governments that generate revenue from beverage tax initiatives direct these funds toward public health and obesity education and prevention efforts with strong evaluation components.” 36 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 Country news Mexico: Taxes are a war on obesity The proposed tax could help prevent 515,000 new cases of diabetes by 2030 and lead to $14 billion in savings for the health system Obesity cost the Mexican health system 42 billion pesos (US$3.2 billion) in 2008 M exico’s lawmakers have declared a war on obesity after they passed a law imposing significant new taxes on junk food and sugary drinks. The taxes will increase the price of junk foods (those high in saturated fat, sugar and salt) by 8%. It will also put one peso on a litre of sugary drinks, which the average Mexican consumed at a rate of 43 gallons per person per year. The money raised is intended to go towards health programmes and increased access to drinking water in schools. Among other measures, the government will introduce a nutritional stamp of approval for healthier foods on sale in supermarkets. “Never before has any civilization faced an epidemic that didn’t involve an infectious disease,” said Enrique Ruelas, president of Mexico’s National Institute of Medicine. “Today, this situation is not only unprecedented, but a threat to the nation’s future.” According to the UN Food and Agricultural Organisation report 32.8% of Mexican adults are obese. The healthcare burden of diabetes and heart disease in Mexico is already impacting lives. Some 9.2% of children in Mexico now have diabetes. Diabetes cost the lives of about 81,000 Mexicans in 2011, almost three times the number of homicides in a nation wracked by violence as drug cartels battle one another and the government for territory. Obesity cost the Mexican health system 42 billion pesos (US$3.2 billion) in 2008, an amount equivalent to 13 percent of spending on health, according to the National Academy of Medicine. Should current trends hold, that cost would rise to 101 billion pesos in 2017. The proposed tax could help prevent 515,000 new cases of diabetes by 2030 and lead to $14 billion in savings for the health system. Mexico has fronted the food and drink industry, and resisted lobbying and warnings that raising prices would do nothing to help the country’s economy. The government believes that any potential economic harm from reduced junk food and soft drink sales, will be insignificant compared with the damage (both social and economic) in years to come if the country’s obesity rates continue to rise. The vote by congress is a triumph for the anti-obesity crusade of President Enrique Peña Nieto, who will now sign the measures into law. As the legislation was passed, he called for a “change of culture” in his country, including the incorporation of at least an hour of exercise for all Mexicans every day. The plan will also award products that meet standards for having lower calories or higher fibre content a ‘seal of nutritional quality’, which he said would give industry an incentive to re-formulate products. He also announced plans for educational, health-monitoring and sports programmes. “We can’t keep our arms crossed in front of a real overweight and obesity epidemic,” the President said. “The lives of millions of Mexicans are literally at risk.” Wales: Two thirds of middle-aged men are overweight Four in 10 men who were overweight said they were making an effort to lose weight N early two thirds of people in Wales in their early 40s are overweight or obese, according to research. A University of London study found 37% of adults were overweight by the age of 42, and men are more likely than women to have a weight problem but are less likely to realise it. A further one in four men (26%) and women (27%) were obese. Researchers studied the BMI of almost 10,000 men and women in Wales, Scotland and England. They found that men in Wales were significantly more likely to be overweight than women in middle age, the research finds. Nearly half of men (46%) were overweight at 42, compared to almost a third of women (30%). In Scotland, the proportion of men and women who were overweight at age 42 was identical to Wales, while obesity rates were slightly lower. The proportion of middle-aged adults in England who were overweight was also similar but the obesity level was again lower, 23% for men and 19% for women. The study authors said that British men were significantly less likely than women to realise they are carrying excess weight. The research was carried out by Dr Alice Sullivan and Matt Brown of the university’s institute of education centre for longitudinal studies. “People who are overweight or obese face a higher risk of many health problems, including cardiovascular disease, diabetes and cer- tain cancers,” said Sullivan. “But carrying excess weight is far more socially acceptable for men than for women and men will not respond to health messages about weight and obesity if they do not recognise that they are overweight. This is a particular concern given that cardiovascular disease is the leading cause of death for men aged 35 and over.” The researchers also found that men and women born in 1970 were considerably more likely to be obese at 42 than those born in 1958 at the same age. “People born in 1970 grew up at a time when lifestyles were becoming increasingly inactive and high-calorie convenience foods were widely available for the first time,” she added. “We know that both exercise and diet are important for maintaining a healthy weight. But our findings show that ready meals, frozen foods, and takeaways are popular with this generation, while nearly a third (32%) of women and a quarter (24%) of men do no vigorous exercise in a typical week.” The researchers also report that only four in 10 men (41%) who were overweight said they were making an effort to lose weight, compared to two thirds (66%) of women. Obese women were also more likely to be trying to lose weight (77%) compared to 62% of obese men. Dr Sullivan presented the findings at a seminar, as part of the Economic and Social Research Council’s Festival of Social Science. She will underline the importance of making men more aware of their BMI status and the health risks associated with excess weight. Nearly half (47%) of men and women born in 1970 said they ate convenience foods, such as frozen fishfingers, burgers, oven chips or readymade pizzas, at least once or twice a week, and 28% ate ready meals once a week or more. Nearly a third (32%) of those who were obese ate takeaways at least once a week, compared to 21% of those who were normal weight. Obesity specialist, Dr Nadim Haboubi, chair of the National Obesity Forum for Wales said poor diets and sedentary lifestyles meant the nation was banking up problems for the future. He said there has been a lack of interest in the disease and the health profession, up until now, has been ineffective in dealing with it. “We have this epidemic, which is rising all over the world, but primarily in the UK – the prevalence of obesity has been halted in the US, but not here and what this report shows is that Wales is worse off than England and Scotland,” said Haboubi, who runs the country’s only NHSfunded obesity clinic at Ysbyty Aneurin Bevan in Ebbw Vale. “Various reports, some of which were commissioned by the Government and National Audit Office have estimated that by 2025 60% of the population may be overweight or obese. “And if the current rise of 3% per year is allowed to continue then it is quite possible that by 2050 85% of the population could be overweight or obese. These are devastating figures and this is a crisis waiting to happen. I don’t think Wales is taking obesity seriously enough. This trend has being going on for so long and is known to those in public health and to politicians and very little has been done. Haboubi said while the problem was now presenting itself among today’s 40-somethings, the problem was equally worrying among children. “The Welsh Government’s Pathway for Obe- Product, Industry and Trial news Apollo Endosurgery buys Allergan’s obesity unit Continued from page 1 2012. Some sources on Wall Street suggested that the unit would be snapped up by a private equity firm, others claimed a more well established medical device firm, whilst it has also been suggested a pharmaceutical company (with obesity drugs in the pipeline) may take the plunge. Apollo certainly faces a tough challenge turning round the units fortunes, which has seen its share of the bariatric surgery market dropped from a high of around 40% to as little as 30%, according to some estimates. Industry analysts expect that the unit’s share of the market will continue to fail given the rise in the number of sleeve gastrectomy procedures. Nevertheless, it is certainly an interesting acquisition by Apollo Endosurgery and one which the whole bariatric community will watch very closely over the coming years. Allergan acquired the Lap-Band business in 2006 as part of a US$3.1bn merger with medical aesthetics company Inamed, along with a line of breast implants. sity, which was a great report, has done very little to change things since it was launched. There are no services available to tackle obesity and prevent those who are overweight from becoming obese and there are no services to ensure those who are obese do not get the associated co-morbidity conditions like diabetes, high blood pressure and stroke.” “The figures are the same among children, 25% are either overweight or obese in Wales. A 10-year-old Welsh child is about 10kg heavier than a child of the same age 30 years ago. There is no doubt that inactivity and poor diets are to blame.” Professor Rhys Williams, a retired professor of clinical epidemiology at Swansea University said obesity is an “horrendous societal problem” that we need to take it even more seriously than we are now. “We are taking the prevention of obesity seriously in Wales – probably as seriously as anywhere else in the UK. We are very aware of the problems but in the UK, as in many other places, its a case of trying to reverse trends in society that are so engrained that they need a super-human effort to shift.” A Welsh Government spokesman said: “We are aware that over half of adults in Wales are overweight or obese – this is something we are addressing. Obesity is a complex issue and our multi-layered approach to tackling it reflects that. We are not simply focused on telling people to lose weight. We have to enable people to make healthy choices, by improving access to a healthy balanced diet, to increase opportunities for physical activity, and to ingrain these habits from childhood.” bariatricnews.net 37 ISSUE 18 | DECEMBER 2013 Product, Industry and Trial news SafeStitch Medical and TransEnterix complete merger Ethicon’s Harmonic ACE+ 7 shears gain FDA approval E 30 million financing raised from existing Transenterix and Safestitch Medical stockholders Combined company to be renamed Transenterix S afeStitch Medical and TransEnterix have closed SafeStitch’s previously announced acquisition of TransEnterix. The combined company is expected to be renamed TransEnterix, subject to stockholder approval, and headquartered in the Research Triangle, NC. The company will continue to trade under the name SafeStitch Medical on the OTCBB under the symbol SFES, until the anticipated name change is approved by stockholders, which is expected to occur in the fourth quarter of 2013. Under the terms of the merger agreement with TransEnterix, SafeStitch Medical issued approximately 105.5 million shares of its common stock to stockholders of TransEnterix, has reserved approximately 17.0 million shares for exercise of TransEnterix options and warrants, and paid an aggregate of approximately US$350,000 in cash to TransEnterix’s former stockholders whose TransEnterix shares did not convert to SafeStitch shares. Concurrent with the closing of the merger, SafeStitch raised $30.2 million, before offering expenses, in a private placement of its equity securities. Existing TransEnterix investors contributed $19.7 million and Dr Phillip Frost and Dr Jane Hsiao, either personally or through affiliated entities, along with other existing SafeStitch investors, contributed an additional US$10.5 million in the financing. Todd M Pope, the Chief Executive Officer of TransEnterix, will serve as the Chief Executive Officer and a Director of the combined company. Paul LaViolette, a Partner at SV Life Sciences and Chairman of TransEnterix, will serve as the Chairman of the combined company’s Board of Directors. Dr Jane Hsiao, the former Chairperson of SafeStitch Medical will continue to serve as a Director of the combined company, and Dr Phillip Frost, Chief Executive Officer and Chairman of OPKO Health and Chairman of Teva Pharmaceutical Industries has joined as a Director. “We believe the business combination with SafeStitch will enhance our ability to bring flexible minimally invasive surgical technologies to market,” said Mr Pope. “This accompanying fundraising provides the company with the resources to advance the development of SurgiBot, a novel patient side minimally invasive surgical robotic system.” The remaining Directors are Dr Aftab R. Kherani, Principal of Aisling Capital; David B Milne, Managing Partner at SV Life Sciences; Dennis J Dougherty, Managing General Partner of Intersouth Partners; Richard C Pfenniger, former Chief Executive Officer of Continucare Corporation and a member of the SafeStitch Board pre-merger; and William N Starling, Managing Director of Synergy Life Science Partners, LP. SafeStitch Medical is a development stage medical device company focused on the development of medical devices that manipulate tissues for the treatment of obesity, gastroesophageal reflux disease, hernia formation, and other conditions through endoscopic and minimally invasive surgery. TransEnterix is a development stage medical device company that is pioneering the use of flexible instruments and robotics to improve how minimally invasive surgery is performed. TransEnterix is focused on the development and commercialisation of SurgiBot, a novel patient side minimally invasive surgical robotic system. thicon Endo-Surgery has announced that its Harmonic ACE+ 7 shears with advanced hemostasis has received 510(k) clearance from the FDA. The company claims that the Harmonic ACE+ 7 shears with advanced hemostasis is the first ultrasonic surgical device indicated to seal vessels up to and including 7mm, while also delivering on the Harmonic promise of precision and multi-functionality. The Harmonic ACE+ 7 represents the latest evolution in the Harmonic legacy of innovation. The device leverages the proprietary Adaptive Tissue Technology, which enables the system to actively sense and adapt to changing tissue conditions and intelligently deliver energy resulting in improved performance with superior precision. “I use Harmonic because it offers me the ability to perform precise dissection that you simply don’t get with an advanced bipolar energy device. However, the advanced bipolar energy devices have always been able to seal larger vessels,” said Dr Bartley Pickron, Colon and Rectal Surgeon, Colorectal Surgical Associates, Houston, Texas. “The addition of the 7mm vessel sealing capability to the Harmonic ACE+ 7 makes it an optimal tool for laparoscopic colon surgery. Previously, I would have to use a Harmonic ACE for tissue dissection and then another device, such as stapler, clips, or endoloops, for control of the larger vascular pedicle. The development of the Harmonic ACE+ 7 has the potential for improved operative efficiency by eliminating instrument exchanges during a procedure. Furthermore, the avoidance of using multiple instruments should result in a cost savings for the overall procedure.” Harmonic ACE+ 7 shears with advanced hemostasis designed for use in numerous procedures and specialties including general, colorectal, bariatric, gynaecology, thoracic and urology, enhancing surgeons’ ability to handle multiple jobs with superior precision. The company believes the new Harmonic ACE+7 is best suited for cases which require dissection, mobilization and large vessel sealing. “We continue to set the standard for performance in both ultrasonic and advanced bipolar energy,” says Tom O’Brien, Ethicon Vice President, Energy Global Strategic Marketing. “The recent introduction of our Enseal G2 Articulating (advanced bipolar) tissue sealer and now the 510(k) clearance of the new Harmonic ACE+7 both demonstrate our commitment to developing meaningful innovations that can help improve outcomes in critical procedures, while giving surgeons the best choices to meet the needs of their unique patients and procedures.” Enseal G2 The company has launched its Enseal G2 Articulating Tissue Sealer in the US. The company claims that the device is the first and only, articulating advanced energy device designed to allow surgeons to take a perpendicular approach to cut and seal vessels up to 7mm in diameter and lymphatics through a 5mm port. The Enseal G2 Articulating is unique because it can bend, making it easier for surgeons to access difficult to reach parts of the anatomy and provides better access to tissue in deep or tight spaces for greater control of the angle of approach to vessels, according to the company1. It allows surgeons to take a perpendicular approach to vessel sealing, which contributes to stronger seals when compared to Enseal non-articulating devices. It also increases their ability to take the full vessel in a single bite, reducing the likelihood of internal bleeding and post-surgery complications for patients. The “Perpendicular Blood Vessel Sealing in Surgical Practice” White Paper, a cross-specialty collaboration between Drs Andrew I Brill and Michael J Stamos, concludes that in certain procedures, “technical accuracy and the security of vessel sealing are best accomplished using a perpendicular approach for the clarification of key anatomy and the optimal use of advanced bipolar electrosurgery.”2 Vessels sealed with a perpendicular approach using Enseal G2 Articulating are more than 28% stronger than vessels sealed at a 45 degree angle.3 “The Enseal G2 Articulating allowed me to perform the entire para-aortic dissection from the same port,” said Dr Steven A Elg, GYN-Oncologist, Iowa Methodist. “Prior to Enseal articulation this was not possible.” Enseal G2 Articulating builds on the company’s existing portfolio of advanced bipolar tissue. The Enseal advanced bipolar devices incorporate an I-Blade that delivers high uniform compression along the entire length of the jaw. The Enseal G2 Tissue Sealer portfolio also includes the Enseal G2 Super Jaw device, launched in 2011, and the Enseal G2 Curved and Straight Tissue Sealers, launched in 2012. References 1.Compared to a non-articulating device. Based on a benchtop burst pressure study. PRC051608 2.“Perpendicular Blood Vessel Sealing in Surgical Practice” – Dr Andrew I Brill, MD and Dr Michael J Stamos, MD. Case ummary, pg 6. 3.Enseal devices tested in a benchtop study on 5-7mm porcine carotid arteries. With NSLG2C35A sealed at a 90° angle compared to vessels sealed at a 45° angle (p=0.001). ovidien has launched two advanced energy devices, the LigaSure Impact curved large jaw open sealer/divider LF4318 and LigaSure blunt tip laparoscopic sealer/divider LF1637. According to the company, the two products offer improvements in handling, control and performance, as compared to their predecessor devices. LigaSure products used with the ForceTriad energy platform utilise TissueFect sensing technology, a proprietary Covidien control system designed to precisely manage energy delivery, creating a range of options for desired tissue effect. The company claims that the LigaSure Impact device, featuring a curved, large jaw open sealer/divider, offers improved visibility in the surgical field, more intuitive jaw positioning and enhanced ergonomics for a better surgical experience. In addition, it is also claimed that the LigaSure blunt tip laparoscopic sealer/ divider has contoured tips for improved dissection, better handling and a more compact, E pressures burst pressures were 28% higher for vessels Company hopes for FDA approval in first half of 2014 C burst (p=0.0007). With NSLG2S35A devices, mean Covidien introduces LigaSure product enhancements decision in the first half of 2014.” EnteroMedics’ proprietary technology, VBLOC vagal blocking therapy, delivered by a pacemaker-like device called the Maestro Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. VBLOC allows people with obesity to take a positive path towards weight loss, addressing the lifelong challenge of obesity and its comorbidities without sacrificing wellbeing or comfort. EnteroMedics’ Maestro Rechargeable System has received CE Mark and is listed on the Australian Register of Therapeutic Goods. median angle compared to vessels sealed at a 45° angle EnteroMedics nears Maestro Rechargeable System approval the coming weeks. “We are very encouraged by the responsiveness of the FDA and are confident in our ability to address their questions in a timely nteroMedics has re- manner,” said Dr Mark B Knudceived a formal response, son, EnteroMedics’ President and a standard component of the PMA process, from the FDA with regard to its Premarket Approval Application (PMA) for approval of the Maestro Rechargeable System as a treatment for obesity. The response contains follow-up questions related to the Chief Executive Officer. “We will application pertaining primarily continue to work closely with to device testing and clinical data, the FDA throughout this process. including training programs for We believe that the Company users and a post approval study. continues on track for a panel in The company anticipates respond- late fourth quarter of of the first ing to the FDA’s questions within quarter of 2014 with approval devices, were 51% higher for vessels sealed at a 90° ergonomic handle for greater comfort and control for various hand sizes. “Around the world, Covidien’s LigaSure devices are a trusted and valued product portfolio in the operating room. LigaSure vessel sealing instruments already are used in millions of surgical procedures and we continue to innovate to enhance our products,” said Chris Barry, President of Advanced Surgical Technologies, Covidien. “Since introduction in 1998, our LigaSure devices, combined with TissueFect sensing technology, have set the standard in vessel sealing.” Both the LigaSure Impact and blunt tip devices received FDA 510(k) clearance earlier in 2013. LigaSure tissue fusion in the ForceTriad energy platform, has faster fusion cycles, more flexible fusion zones and less desiccation than the original LigaSure generator. TissueFect sensing technology monitors changes in tissue 3,333 times a second and adjusts energy output accordingly to deliver the appropriate amount of energy for the desired tissue effect. 38 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013 Calendar of events 2013/14 December 12–14 First Gulf Obesity Surgery Society Meeting Kuwait City, Kuwait www.gulfobesity.com/ March 12–16 April 30–May 3 2014 Spring Obesity Conference January 13 Philadelphia, United States www.asbp.org/physiciansclinicians/resources/ events.html?start=5 6th Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders, European Chapter Obesity Update 2014 London, United Kingdom www.asbp.org/cmecertification/livecme/ internationalobesityupdate.html December 13 5th Emergencies in Bariatric Surgery Course January 22–24 London, United Kingdom [email protected] 5th British Obesity and Metabolic Surgical Society (BOMSS) Annual Meeting December 14 4th Annual Meeting of the European Society for Perioperative Care of the Obese Patient Bruges, Belgium www.espcop.org 2014 Kenilworth, United Kingdom www.bomss.org.uk/2014conference/ March 9–11 Brussels, Belgium www.ifsobrussels.com/ March 17–20 June 25–28 12th International Congress on Obesity Kuala Lumpur, Malaysia www.iaso.org/events/ico/ico-2014/ 14th World Congress of Endoscopic Surgery Paris, France www.eaes.eu/eaes-meetings/ 14th-world-congress-paris.aspx March 24-27 Society for Endocrinology Liverpool, UK www.endocrinology.org/meetings/sfebes/ index.aspxcom/ August 26–30 IXX IFSO World Congress Montreal, Canada www.ifso2014.org 12th International Expert Meeting for the Surgery Obesity and Metabolic Disorders Salzburg, Austria www.obesity-online.com/expertmeeting/ To list your meeting details here, please email: [email protected] BNEWS ARIATRIC The next issue of Bariatric News is out in March Editorial deadline: 10 February 2014 Advertising deadline: 10 February 2014 If you are interested in submitting an article for the newspaper, please contact: [email protected] If you are interested in advertising in Bariatric News, please contact: [email protected] If you would like to submit a press release, please email: THE NEWSPAP ER DEDICATE IN THIS ISS UE… Bariatric surgery in Kuwait In an exclusive interview with Dr Salman Al Sabah we report on the current status of bariatric surger y in Kuwait Coffee Time Professor Mervy n Deitel talks to Bariatric News about his career and the evoluti on of bariatric surgery 8 Mini-Gastric Bypass Conference An special report from the 2nd Internation Consensus Conference 13 Variety of facto rs The impact of bariatric surger y on risk factors for cardiovascular disease depen ds on a variety of factors, including the type of surgery, sex, ethnic background, and pre-surgery BMI D TO THE TREA TMENT OF OBES ITY FOR THE HEAL THCARE PROF ESSIONAL ISSUE 18 | Clinical comm ent Canada: Acce to surgery ss Nicolas Chris tou discusses access to baria surgery in Canatric the publically da under -funded healthcare syste m DECEMBER 2013 More time n the costs eeded to recupera of bariatric te surgery Page 17 Based on proje ction would take more s, it than ten years to reco ver the costs of the LRYGB procedure. between Januar y 2003 and September 31 2009. LAGB and LRYGB claimants were propen HE time taken sity score match to recuperate ed to two the control sampl costs from bariatr es: one restric ic surgery are ted to those with a MO more likely diagnosis code to be double 5.25 years the and one without this previously estima restriction. The laparoscopic ted for sample of random adjustable gastric 120,00 0 individuals (LAGB), accord band provided directl was ing y from sessed ‘The Busin to a study that asPropensity score Medstat. ess Case for matching was Bariatric Surgery Revisi to ensure that used ted: A Non-R the andomized Case-Control similar as possib four groups were as Study busine le. LRYGB ss case for bariatric surger were patien matched to LAGB ts y’, published online in the journal patients based on patient and PlosOne (Octob health er 2013). plan characterThe authors istics, and on conclude that diagnoses and the time to recuperate the the year prior costs in costs to the quarte Roux-en-Y gastric from laparoscopic r before the bariatric proced bypass (LRYG ure. greater given B) would Using the four the procedure matched sampl results in increa be even recuperate the stay and proced an analysis datase costs using an sed hospital es, ure time. t was create does not rely alternative sampl The study author included d that on the MO diagno e that inpatie s state that previo sis code. nt (both facilit quarterly payments of total, “Regardless have examined us studies that of the time y and physic the (including payme to breakeven, pointing out ian), non-inpatien on a comparison cost of bariatric surgery it is worth nts for hospit that the expec have relied t sample of those al outpatient, office visits, tation for any intervention (MO) diagno with a morbi physician’s and emergency to show a return surgical tion sis code, despit d obesity and department), on investment drug claims. e the fact that group might few effective and prescripis unusual this high cost not be a true relative to (pseud Each quarter represented the authors state. interventions reach this reflection of eventually have the o) band placem threshold,” time patients who “LAGB, howev LAGB or LRYG ent. exceptions.” er, may be one result, this study B procedures. of the Resu re-estimated As a lts The analysis the net costs is and time to A total of 9,631 ketScan Comm based on claims data from patients (after the Mar- ing ercial Claims matching), were and Encounters in each surgic includal group. The database groups of patien ts are 6 T Apollo Endo surgery buys Allergan’s ob esity unit A Continued on Medicare Co E policy could limit minority access to surgery Evidence Continued on POLLO Endosurgery has talent to completed the our acquisition of the be a cataly team, this acquisition will obesity interv ention divisio st for growth Allergan, which as we continue n of advan manufactures ce technologies to weight loss and sells iatric in the fields of solutio and minimally barLap-Band adjust ns comprised of the invasive surger Apollo, who y.” able gastric announced the system and the banding tion acquisiOrbera intra-g in October astric balloon system. 2013, will 25 the unit for up purchase to US$110 millio “With world total includes n. This wide obesity Country news an upfron reaching epidem numbers US$75 t cash payme ic nt of million, a minor 36 of the Lap-Band levels, the acquisition in ity equity interes Apollo by Allerg and t gies places Apollo the Orbera technolo- and Industry and produ an of US$15 millio up Endosurgery ct news 39 ership positio in a lead- contin to US$20 million in additio n, n to provide gent consideration nal surgeons and patients with to be paid upon achievement innovative and Calendar of even of certain regula less invasive solutions in the ts sales milestones. tory and fight against obesit 42 Dennis McWi y,” said lliams The of Apollo Endos , President and CEO lation, deal comes after a year of specuurgery. “By since the Allerg expanding both our produ an announced were planning ct portfolio they to sell the unit and adding in October page 38 page 3 supporting or discontinuing baria is ‘inconclusive’ tric CoE vs. non-Medicar e patients before after implem and entation of a Medic coverage policy , reported a declin are the number e in of minority patients with HE policy of Medicare receiv treating Medic ing bariatr are after the bariatric surger policy was implem ic surgery y patients at high-volume ented. “The Medicare center hospitals designated as Cente s of excellence policy rs of Excellence was associated be blocking could percen with a 4.7 obese minor tage point (17 ities’ access to care, accord percent) declin in the proportion ing to ‘Baria e of Medicare tric gery in Minor patients ity Patients Before Sur- receiving bariatr ic surgery who After Implementa and non-w were hite,” said Dr tion of a Cente Excellence Progra Lauren Hersc rs of Nicho las, h m’, published in JAMA (JAMA online an assista lead author of the letter and . 2013 310(1 nt profes sor 3):139 400.). with the Depar 9- ment of tHealth Policy The study, which and Management at Johns Hopki compared rates bariatric surger ns of School y for minority of Public Health Bloomberg Medicare . “It appears T Continued on page 3 [email protected] EDITORIAL BOARD Henry Buchwald Simon Dexter John Dixon MAL Fobi Ariel Ortiz Lagardere BARIATRIC NEWS Managing Editor Owen Haskins [email protected] Industry Liaison Manager Martin Twycross [email protected] 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 © 2013 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. Our website… Bariatricnews.net Stay informed. Get involved. Be heard. Register your interest and be kept informed with regular updates: email [email protected] If you’ve got an idea for an article, suggestions for topics to cover, or would like to take part in a debate, we’d love to hear from you. Email [email protected] Send press releases to [email protected] For advertising options, email [email protected] Our newspaper… Bariatric News BNEWS ARIATRIC FREE subscription. For your free subscription email your full postal address to: [email protected] THE NEWSPAPER DEDICATED IN THIS ISSUE… Bariatric surgery in Kuwait In an exclusive interview with Dr Salman Al Sabah we report on the current status of bariatric surgery in Kuwait 6 Professor Mervyn Deitel talks to Bariatric News about his career and the evolution of bariatric surgery 8 Mini-Gastric Bypass Conference Like us on Facebook: facebook.com/bariatricnews ITY FOR THE HEALTHCARE PRO An special report from the 2nd Internation Consensus Conference 13 Variety of factors Based on projections, it would take more than ten years to recover the costs of the LRYGB procedure. 25 Country news 36 A Industry and product news 39 Clinical comment Canada: Access to surgery Nicolas Christou discusses access to bariatric surgery in Canada under the publically-funded healthcare system Page 17 between January 2003 and September 31 2009. LAGB and LRYG B claimants were propensity score match ed to two control samples: one restric ted to those with a MO diagnosis code and one without this restriction. The random sample of 120,000 indivi duals was provided directly from Meds tat. Propensity score matching was used to ensure that the four group s were as similar as possible. LRYG B patients were matched to LAGB patien ts based on patient and health plan characteristics, and on diagnoses and costs in the year prior to the quarte r before the bariatric procedure. Using the four matched samples, an analysis dataset was created that included quarterly payments of total, inpatient (both facility and physician), non-inpatient (including payments for hospit al outpatient, physician’s office visits, and emergency department), and prescription drug claims. Each quarte r represented the time relative to (pseudo) band placem ent. T recuperate the costs using an alternative sample that does not rely on the MO diagn osis code. “Regardless of the time to breakeven, it is worth pointing out that the expec tation for any surgical intervention to show a return on investment is unusual and few effective intervention s reach this threshold,” the authors state. “LAGB, however, may be one of the Results exceptions.” A total of 9,631 patients (after The analysis is based on claim matching), were includs data from the Mar- ing in each surgical group. The ketScan Commercial Claim groups of patients are s and Encounters database Apollo Endosurgery buys Allergan’s obesity unit The impact of bariatric surgery on risk factors for cardiovascular disease depends on a variety of factors, including the type of surgery, sex, ethnic background, and pre-surgery BMI FESSIONAL 2013 More time needed to re the costs of bariatric cuperate surgery HE time taken to recuperate the costs from bariatric surger y are more likely to be doubl e the 5.25 years previously estima ted for laparoscopic adjustable gastri c band (LAGB), according to a study that assessed ‘The Business Case for Bariatric Surgery Revisited: A Non-R andomized Case-Control Study busine ss case for bariatric surgery’, published online in the journal PlosOne (Octo ber 2013). The authors conclude that the time to recuperate the costs from laparoscopic Roux-en-Y gastric bypass (LRYGB) would be even greater given the procedure results in increased hospital stay and procedure time. The study authors state that previous studies that have examined the cost of bariatric surgery have relied on a comparison sample of those with a morbid obesit y (MO) diagnosis code, despit e the fact that this high cost group might not be a true reflection of patients who eventually have LAGB or LRYGB procedures. As a result, this study re-estimate d the net costs and time to Coffee Time Follow us on Twitter: @bariatricnews TO THE TREATMENT OF OBES ISSUE 18 | DECEMBER POLLO Endosurgery has talent to our team, this acquisition will completed the acquisition of the be a catalyst for growt h as we continue to obesity intervention divisi on of advance technologies Allergan, which manufactur in the fields of bares and sells iatric and minim ally invasive surgery.” weight loss solutions comp rised of the Apollo, who announced the Lap-Band adjustable gastri acquisic banding tion in Octob er 2013, will purchase system and the Orbera intra-g astric bal- the unit for up to US$110 million. This loon system. total includes an upfront cash “With worldwide obesity payment of numbers US$75 million, a minority equity interest reaching epidemic levels, the acquisition in Apollo by Allergan of US$15 million, of the Lap-Band and the Orber a technolo- and up to US$2 0 million in additional gies places Apollo Endosurgery in a lead- contingent consid eration to be paid upon ership position to provide surgeons and achievement of certain regu patients Continued on page 3 Medicare CoE policy could limit minority access to surgery Evidence supporting or discontinuing bariatric CoE is ‘inconclusive’ vs. non-Medicare patients before and after implementation of a Medicare coverage policy, reported a decline in the number of minority patien ts with Medicare receiving bariat ric surgery HE policy of treating Medic are after the policy was implemented. bariatric surgery patients at “The Medicare centers of high-volume hospitals desigexcellence policy was associated nated as Centers of Excel with a 4.7 lence could percentage point (17 percent) decline be blocking obese minorities’ access in the proportion of Medicare patients to care, according to ‘Baria tric Sur- receiving bariat ric surgery who were gery in Minority Patients Before and non-w T