Page 2: Baker IDI. Page 4: Baker IDI. Global & Regional Obesity. High income English speaking Light Blue. Global & Regional Severe obesity

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1 Metabolic Surgery Update Patients selection and choice of procedure Professor John B Dixon MBBS, FRACGP, FRCP Edin, PhD NHMRC Senior Research Fellow Head of Clinical Obesity Research, Baker IDI Heart and Diabetes Institute Adjunct Professor School of Primary Health Care, Monash University Disclosures: Professor John B Dixon Apollo Endosurgery Consultant, Research Support Bariatric Advantage Consultant, Speakers BUPA Research Support Dendrite Clinical Systems Speaker fees I-Nova Consultancy, Speaker and educational material Medtronics Speaker fees and consultancy Nestle Health Science Consultant NHMRC Research Support Nova Nordisk Advisory board and speaker fees Novartis Advisory board Novartis Advisory board RACGP Research Support Page 2: Baker IDI Metabolic surgery v traditional Bariatric surgery Metabolic surgery GI surgery designed with the intent to treat type 2 diabetes and obesity It requires a diabetes based model of clinical practice consistent with international standards of diabetes care Surgery should be performed in high volume centres that understand and are are experienced in the management of diabetes and GI surgery Standard procedures should be used Accepted conventional techniques This has always been a clear message from non-surgeons All have their own risks and benefits There are now multiple new diabetes procedures, however in Australia we appear to be largely followers not leaders in new self-styled variants Page 3: Baker IDI Page 4: Baker IDI BMI trends in Australian adults Global & Regional Obesity 2013 Adult Obesity 28% High income English speaking Light Blue Global & Regional Severe obesity Walls & Magliano et al, Obesity 2011 Page 5: Baker IDI Page 6: Baker IDI 1

2 Percentage Increase (Baseline 1986) 1000% 900% 800% 700% 600% 500% 400% 300% 200% 100% 0% Increasing Prevalence of Extreme Obesity BMI >30 BMI >35 BMI >40 BMI >45 BMI > Diabetes around the world Page 7: Baker IDI Sturm R. Public Health. 2007;121: Page 8: Baker IDI Australian s with type 2 Diabetes 2011 Clinical Terms Used to Describe Various Levels of Body Fat * Let s look at those with diabetes in Australia NORMAL BMI OVERWEIGHT BMI Class I BMI Class II BMI Class III BMI 40 12% 29% 29% 16% 14% Management and Impact for Long-term Empowerment and Success * BMI (Body Mass Index): A measurement of an individual s weight in relation to height (kg/m 2 ). Page 9: Baker IDI Page 10: Baker IDI In press Dixon et al, DRCP 2013 Australian s with type 2 Diabetes 2011 Clinical Terms Used to Describe Various Levels of Body Fat * Australian s with type 2 Diabetes 2011 Clinical Terms Used to Describe Various Levels of Body Fat * NORMAL BMI OVERWEIGHT BMI Class I BMI Class II BMI Class III BMI 40 NORMAL BMI OVERWEIGHT BMI Class I BMI Class II BMI Class III BMI 40 70% Women 12% 29% 29% 16% 14% 12% 29% 29% 16% 14% Page 11: Baker IDI 30% in the severely obese categories * BMI (Body Mass Index): A measurement of an individual s weight in relation to height (kg/m 2 ). Page 12: Baker IDI 30% in the severely obese categories * BMI (Body Mass Index): A measurement of an individual s weight in relation to height (kg/m 2 ). 2

3 Change from Baseline (%) Mean Weight Loss Mean % Weight Loss 0% -1% -2% -3% -4% -5% -6% -7% -8% -9% -10% -11% Study Week Physiological range The compounding stressors of severe obesity in patients with diabetes Disability Depression Women Severe Obesity Education Employment Household Income SO WHY DO WE NEED SURGERY TO PROVIDE SUSTAINED WEIGHT LOSS AND TREAT OBESITY RELATED COMPLICATIONS LIKE TYPE 2 DIABETES? Along with obesity related disease this presents complex management issues Page 13: Baker IDI Dixon et al, DRCP 2013 Page 14: Baker IDI Every essential for a functional life must be carefully regulated Temperature Oxygen saturation Blood pressure Blood glucose Fuel stores The regulation of energy stores is still working when a obese patient has lost weight following bariatric surgery Page 15: Baker IDI Page 16: Baker IDI Satiety Dose response curve A change in regulation LEAN OBESE Bariatric surgery or effective medical therapy Meal Size Per Carel Le Roux 0 Time (Weeks) Obesity Treatment Pyramid Placebo Phentermine Topiramate Qnexa Surgery Surgery -12 Weeks Look at the groups that did not get effective therapy Diet & Exercise and a placebo therapy Devices Diet Physical Activity Combination VLCD Diet Physical Activity Combination VLCD Diet Physical Activity Page 17: Baker IDI Average weigh for participants is approximately 100kg Lifestyle Modification Lifestyle Modification Lifestyle Modification Current Interim Future Page 18: Baker IDI 3

4 Percentage change in weight (%) Effective therapies are rarely used Therapeutic clinical inertia +++ Surgery Surgery Devices WHAT IS THE EVIDENCE? Diet Physical Activity Combination VLCD Diet Physical Activity Combination VLCD Diet Physical Activity Lifestyle Modification Lifestyle Modification Lifestyle Modification Current Interim Future Page 19: Baker IDI Page 20: Baker IDI Surgical therapy v Lifestyle-Medical 11 randomized controlled trials The evidence 11 RCTs Surgical therapy superior for weight loss and HbA1c Page 21: Baker IDI Diabetes Care in press 2016 Page 22: Baker IDI The evidence 11 RCTs Efficacy Weight Loss 0 Baseline 6-months 12-months 18-months 24-months T2DM Surgical -5 T2DM Conventional ModBMI Surgical ModBMI Medical Adol Surgical -20 Adol lifestyle -25 OSA Surgical OSA Conventional -30 Ann Intern Med, (2006). 144(9): p JAMA, (2008). 299(3): p ; JAMA, (2010). 303(6): p ; JAMA, (2012). 308(11): p Page 23: Baker IDI Page 24: Baker IDI 4

5 HbA1c (%) HbA1c LAGB 73% v 13% remission Surgical Conventional Baseline 6-months 12-months 18-months 24-months Months after randomization When should Metabolic Surgery be performed? The indications for surgery have two levels of eligibility Surgery is an option for this patient Surgery is recommended for this patient In the second case a trained caring physician should alert the patients to the recommendation and refer if and when appropriate Dixon, J. B., P. E. O'Brien, et al. (2008). "Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial." Jama 299(3): Page 25: Baker IDI Page 26: Baker IDI The classification of weight category by BMI All countries use BMI criteria in their criteria for B - D surgery Classification BMI(kg/m 2 ) Principal cut-off points Normal range Pre-obese Obese class I Obese class II Cut-off points for Asians Obese class III For Asian populations classifications remain the same as the international classification but that public health action points for interventions are set at 23, 27.5, 32.5 and 37.5 We address eligibility and prioritization for bariatric surgery within the coloured zones above Source: Adapted from WHO BMI is an excellent measure of fatness India China Singapore Taiwan & others have adapted Eligibility and prioritisation for bariatric surgery based on failed non-surgical weight loss therapy, BMI, ethnicity and disease control BMI Range Eligible for surgery Prioritised for Surgery < 30 No No YES-Conditional* No YES YES-Conditional* > 40 YES YES *HbA 1c > 7.5 despite fully optimised conventional therapy, especially if weight is increasing, or other weight responsive comorbidities not achieving targets on conventional therapies (e.g. blood pressure, dyslipidaemia, obstructive sleep apnoea) IDF- Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes Page 27: Baker IDI Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes Page 28: Baker IDI National and international guidelines for eligibility for bariatric surgery (adults) NIH (USA) European ADA (USA) SIGN (Scotland) NHMRC (Australia) NICE (UK) Year DSS II Recommended >50 Eligible (A):BMI >40 >40 >40 >40 >40 Eligible (B):BMI with with if serious weight weight loss control of loss responsive diabetes and responsive comorbidity comorbidity comorbidity is difficult >35 with 1 serious weight loss responsive comorbidity with 1 serious weight loss responsive comorbidity with disease that could improve with weight loss Historic If Diabetes is poorly controlled The guidelines above are qualified by the following common elements: Appropriate non-surgical weight loss measures have been tried and failed; there is the provision for, and a commitment to, long term follow-up; and individual Page 29: Baker IDI risk to benefit ratio needs to be evaluated If Diabetes is poorly controlled Within 10 years of diagnosis Page 30: Baker IDI 5

6 Recommended for the patient Metabolic surgery should be a recommended option in appropriate surgical candidates with class III obesity (BMI 40) regardless of the level of control or complexity of glucose lowering regimens And in patients with Class II obesity (BMI ) with inadequately controlled hyperglycaemia despite lifestyle and optimal medical therapy Considered an option for the patient Metabolic surgery should be considered and option to treat type 2 diabetes in all patients with class II (BMI 35-40) obesity And in patients with class I obesity (BMI 30-35) and inadequately controlled hyperglycaemia despite optimal medical therapy with either oral or injectable medications including insulin. Page 31: Baker IDI Page 32: Baker IDI Algorithm for the treatment of T2D, as recommended by DSS-II voting delegates Surgery is impressive and benefits extend well beyond a glucocentric approach Reduced mortality Cardiovascular Cancer Diabetes Improved QOL in both physical and mental domains Improvement or remission of all obesity related complications Highly cost effective especially for diabetes Page 33: Baker IDI Page 34: Baker IDI Obesity Is Linked to a Large Number of Serious Medical Conditions Four groups All propensity matched Pulmonary Disease Abnormal Function Obstructive Sleep Apnea Hypoventilation Syndrome Asthma Nonalcoholic Fatty Liver Disease Steatosis Steatohepatitis Cirrhosis Gall Bladder Disease Gynecologic Abnormalities Abnormal Menses Infertility Polycystic Ovarian Syndrome Skin Problems Gout Obesity-related Co-morbidities¹ Idiopathic Intracranial Hypertension Stroke Cataracts Coronary Heart Disease Dyslipidemia Hypertension Diabetes Severe Pancreatitis Cancer Breast, Uterus, Cervix, Colon, Esophagus, Pancreas, Kidney, Prostate Osteoarthritis Phlebitis Venous Stasis LAGB patients RYGB patients Morbid obesity classified controls Cost and disease matched controls All of these groups had matched costs and matched disease prior to the surgery or psudosurgery date Page 35: Baker IDI Bhoyrul. J Manag Care Med Page 36: Baker IDI 6

7 Tracking costs before and after surgery in a subset with type 2 diabetes Costs Time to breakeven A B C A - total cost B Inpatient C Outpatient D - Medication D Page 37: Baker IDI Page 38: Baker IDI Accepted conventional techniques This has always been a clear message from non-surgeons All have their own risks and benefits There are now multiple new diabetes procedures, however in Australia we appear to be largely followers not leaders in new self-styled variants Page 39: Baker IDI Page 40: Baker IDI Dixon, J.B., C.W. le Roux, F. Rubino and P. Zimmet, Bariatric surgery for type 2 diabetes. Lancet, (2012). 379(9833): p Who responds well? Page 41: Baker IDI Key determinants of diabetes remission Page 42: Baker IDI Gastric bypass 65% remission Duration of Diabetes Adequate beta-cell function Fasting C-peptide Insulin resistant and adequate beta-cell function BMI You must have weight to lose (% Weight Loss) You must lose weight Dixon, J.B., Lee WJ, et al Diabetes Care, (2013). 7

8 Bariatric-metabolic surgery SOS study - IDF Melbourne 2013 Sustained weight loss Sustained improvement in ALL obesity related comorbidity and HRQOL Excellent safety profile Many studies show it is not just cost effective but provides a return on the health care investment without taking into account productivity gains! 31% still in remission at 15 years Diabetes complications cases v controls Adjusted OR 0.53 ( ) Those with diabetes that had a reduction in micro & macrovascular complications are treated within 3 years of a diagnosis of type 2 diabetes Peltonen et al, Diabetes remission and complications over 15 years in SOS study IDF 2013 Page 43: Baker IDI Page 44: Baker IDI Chronic Care Management Model 1. Community Resources and Policies Right thing Right patient Right time Page 45: Baker IDI Informed, Activated Patient 3. Self-Management Support Productive Interactions Improved Outcomes 2. Health System Health Care Organization 4. Delivery 5. Decision 6. Clinical System Support Information Design Systems Prepared, Proactive Practice Team Wagner, E.H. Chronic Disease Management: What Will It Take to Improve Care for Chronic Illness? Effective Clinical Practice 1998; 1:2-4. The serial accumulation of impressive data 2006 Data from 4 studies indicating that bariatric surgery saves lives Cardiovascular, Diabetes, Cancer. The evidence that the risks of surgery have plummeted with the laparoscopic approach and quality training the technology used in surgery has been revolutionised Risk less than gall bladder surgery No deaths in UK last year. The durability of weight loss SOS and many more The 11 randomized controlled trials Health economic data highly cost effective and for those with type 2 diabetes possibly dominant Change underway, but the systems to implement the needed changes are not established Page 46: Baker IDI Conclusion Chronic disease management is integrated health not medicine v surgery Surgery compliments conventional therapy Endocrinologists and diabetologists need to engage bariatric-metabolic surgical teams to assist with the management of their numerous patients who are eligible or prioritized for surgery We need to remove the current negligence in managing obesity and address this chronic disease Surgery is not a last resort. Get in EARLY NSW 6,000 procedures a year 60 in public hospitals Gavin Lambert Division of Hypertension, Obesity and Stress Clinical Obesity Research Markus Schlaich Toni Rice Nora Straznicky Elisabeth Lambert Mariee Grima Page 47: Baker IDI Page 48: Baker IDI 8