25/10/2017. Obesity Treatment Pyramid. Australian s BMI - 28% are obese. Bariatric-Metabolic Surgery: What the GP needs to know

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1 Bariatric-Metabolic Surgery: What the GP needs to know Disclosures: Professor John B Dixon Professor John B Dixon Head of the Clinical Obesity Research Laboratory Baker Heart and Diabetes Institute, Melbourne NOF Brisbane 9 August 2017 Apollo Endosurgery Bariatric Advantage BUPA I-Nova Medtronics Nestle Health Science NHMRC Nova Nordisk Novartis RACGP Res-Med Australian Family Physician July 2017 Advisory board and speaker fees Advisory board and speaker fees Obesity Treatment Pyramid Surgery Surgery Devices Lap Band Endobarrier Pharmacotherapy VLED Combination Pharmacotherapy Combination Pharmacotherapy VLED VLED Diet Physical Activity Diet Physical Activity Diet Physical Activity Lifestyle Modification Lifestyle Modification Lifestyle Modification Current Interim Future What I will attempt to cover What is bariatric-metabolic surgery? Efficacy and safety Health outcomes Indications for surgery Recommended vs Eligibility How does it work Pre-operative assessment Procedure selection Complications Long-term care Health economics and access to care NORMAL BMI Australian s BMI - 28% are obese Clinical Terms Used to Describe Various Levels of Body Fat * OVERWEIGHT BMI Class I BMI Class II BMI Class III BMI 40 36% 36% 20% 5% 3% The number in the class II and III has grown 8-10 fold since 1980 Class II and III adults = 1,000,000 2/3 of those with severe obesity are women Aims of chronic disease management Improve health outcomes Engage the patient as playing a central role Improve quality of life Improve function Reduce end-organ damage Reduce morbidity and mortality The aim is not just! * BMI (Body Mass Index): A measurement of an individual s weight in relation to height (kg/m 2 ). 1

2 Bariatric & metabolic surgery: metabolic added to the name this century All are performed laparoscopically Adjustable gastric band Sleeve Gastrectomy Roux-en Y gastric bypass 10% 70% 20% Pulmonary Disease Abnormal Function Obstructive Sleep Apnea Hypoventilation Syndrome Asthma Nonalcoholic Fatty Liver Disease Steatosis Steatohepatitis Cirrhosis Gall Bladder Disease Obesity Is Linked to a Large Number of Serious Medical Conditions Gynecologic Abnormalities Abnormal Menses Infertility Polycystic Ovarian Syndrome 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 Skin Problems Osteoarthritis These 3 are the most commonly used in Australia I would caution against the use of other surgical procedures Gout Bhoyrul. J Manag Care Med Phlebitis Venous Stasis Sjostrom, L. (2012). J Intern Med. Health outcomes: Mortality risk - Complications Comorbidities Patient reported outcomes Bariatric-Metabolic Surgery saves lives 14 studies; 29,208 underwent bariatric surgery and 166,200 nonsurgical controls This has been the focus of my last 20 years research so let us look at some highlights only Mortality Type 2 diabetes Quality of Life Depression Sleep OSA and quality Eating - BED Idiopathic Intracranial Hypertension Pulmonary Disease Stroke Abnormal Function Obstructive Sleep Apnea Cataracts Hypoventilation Syndrome Asthma Coronary Heart Disease Dyslipidemia Nonalcoholic Fatty Hypertension Liver Disease Steatosis Steatohepatitis Diabetes Cirrhosis Severe Pancreatitis Gall Bladder Disease Gynecologic Abnormalities Cancer Abnormal Menses Breast, Uterus, Cervix, Infertility Colon, Esophagus, Polycystic Ovarian Syndrome Pancreas, Kidney, Prostate Skin Problems Osteoarthritis Gout Phlebitis Venous Stasis Hazard Ratio 0.6 (0.49 to 0.74) 50% reduction in CV deaths 50% reduction in cancer deaths Bhoyrul. J Manag Care Med Kwok CS et al. Int J Cardiol

3 B-M Surgery vs Conventional therapy for type 2 diabetes: 11 RCTs National and international guidelines for eligibility for bariatric surgery (adults) NIH (USA) European ADA (USA) SIGN (Scotland) NHMRC (Australia) NICE (UK) Year Recommended >50 Eligible (A):BMI >40 >40 >40 >40 >40 Eligible (B):BMI with 1 serious with if control of >35 with 1 serious weight with 1 serious diabetes and loss is difficult with disease that could improve with Surgery is clearly superior to conventional therapy in managing patients with obesity and type 2 diabetes Historic The guidelines above are qualified by the following common elements: There is the provision for, and a commitment to, long term follow-up; and individual risk to benefit ratio needs to be evaluated Within 10 years of diagnosis SF-36 Generic health related QOL scores Baseline & 5 years follow-up, compared with US population Mental Health (MH) Role Emotional (RE) Physical Function (PF) Role Physical (RP) Body Pain (BP) 5 Year US Population Baseline IWQOL-Lite Obesity specific health related QOL Baseline and 5-years Work Total Physical Function 5-year Baseline Sexual Life Public Distress Social Function (SF) General Health (GH) Vitality (VT) Ware J. SF-36 Health Survey: Manual and Interpretation Guide. Boston: The Health institute, New England Medical Center; Self-Esteem Kolotkin RL, Head S, Brookhart A. Construct validity of the Impact of Weight on Quality of Life Questionnaire. Obesity research. 1997;5(5): Symptoms of Depression: Sustained changes over 5 years Binge Eating Disorder out of control eating Beck Depression Inventory II: symptoms of depression BDI-II score 8.8± ± ± ± ± ±6.7 Binge eating disorder (QEWP-R) No of subjects N (%) with disorder c 20 (13.4%) 0 1 (0.7%) 1 (0.8) 1 (1%) 4 (4%) Three factor Eating Questionnaire Cognitive restraint a 10.4± ± ± ± ± ±4.1 Disinhibition a 9.6± ± ± ± ± ±3.2 Hunger a 7.1± ± ± ± ± ±2.9 Beck Depression Inventory II: symptoms of depression BDI-II score 8.8± ± ± ± ± ±6.7 Binge eating disorder (QEWP-R) No of subjects N (%) with disorder c 20 (13.4%) 0 1 (0.7%) 1 (0.8) 1 (1%) 4 (4%) Three factor Eating Questionnaire Cognitive restraint a 10.4± ± ± ± ± ±4.1 Disinhibition a 9.6± ± ± ± ± ±3.2 Hunger a 7.1± ± ± ± ± ±2.9 3

4 Physiological range How does surgery work? Every essential for a functional life must be carefully regulated Temperature Oxygen saturation Blood pressure Blood glucose Fuel stores Satiety Dose response curve A change in regulation LEAN OBESE We carefully defend our fat Bariatric surgery or effective medical therapy The regulation of energy stores is still working when a obese patient has lost weight following bariatric surgery Meal Size Per Carel Le Roux Three factor eating questionnaire Sustrined change over 5 years Indication and Contraindications for B-M Surgery Beck Depression Inventory II: symptoms of depression BDI-II score 8.8± ± ± ± ± ±6.7 Binge eating disorder (QEWP-R) No of subjects N (%) with disorder c 20 (13.4%) 0 1 (0.7%) 1 (0.8) 1 (1%) 4 (4%) Three factor Eating Questionnaire Cognitive restraint a 10.4± ± ± ± ± ±4.1 Disinhibition a 9.6± ± ± ± ± ±3.2 Hunger a 7.1± ± ± ± ± ±2.9 Indications are based on BMI and obesity related risk and complications The following are eligible BMI > 40 BMI > 35 with one or more complication BMI with poorly type 2 diabetes It is a recommended therapy patients with Type 2 diabetes if BMI > 40 BMI > 30 if poorly There are few contraindications Too sick for general anaesthesia or have a limited life expectancy due to organ failure Active substance abuse (alcohol or drugs) Serious mental health conditions that are poorly Metastatic malignancy Unable to provide informed consent or assent for surgery Specific gastrointestinal complication Seek expert advice if in doubt do not presume Ching Lee, P. and J. Dixon (2017). Aust Fam Physician 46(7): National and international guidelines for eligibility for bariatric surgery (adults) Algorithm for the treatment of T2D NIH (USA) European ADA (USA) SIGN (Scotland) NHMRC (Australia) NICE (UK) Year Recommended >50 Eligible (A):BMI >40 >40 >40 >40 >40 Eligible (B):BMI with 1 serious with if control of >35 with 1 serious weight with 1 serious diabetes and loss is difficult with disease that could improve with Historic Within 10 years of diagnosis The guidelines above are qualified by the following common elements: There is the provision for, and a commitment to, long term follow-up; and individual risk to benefit ratio needs to be evaluated Diabetes Care 2016;39:

5 3. Self-Management Support Health Care Organization 4. Delivery 5. Decision 6. Clinical System Support Information Design Systems Presentation title Date 28 Pre-operative assessment and management History: Weight history, attempts, Assess obesity related complications and risks. Identify major concerns and current lifestyle issues Physical Examination: BMI, neck and waist circumference, Blood pressure, Endocrine issues Cushing's syndrome, Hypothyroidism, obesity related syndromes, physical mobility, skin and legs. Investigation: Cardio-metabolic-nutritional screening (ALL), Selective referral GI investigations endoscopy or ultrasound, Cardiac, Sleep-Respiratory Psychological evaluation: High risk group so a low threshold to referral to psychological assessment Nutritional: Evaluation by a dietitian is essential pre-surgery Management: Optimise health, stop smoking, preoperative VLED Ching Lee, P. and J. Dixon (2017). Aust Fam Physician 46(7): Pre-operative tuning up of complications Post surgical outcomes Obesity-related Pre-operative screening and optimisation Improvement after post-surgery complication HbA1c and fasting glucose to screen for diabetes. Better glycaemic control and a reduced medication burden. Type 2 diabetes Aim for good glycaemic control (HbA1c <7%) prior to Diabetes remission in some cases. surgery. ECG and cardiac risk assessment. Reduction of cardiovascular morbidity of >50% (compared to Cardiovascular Referral to cardiology if high CV risk, presence of cardiac BMI and age matched controls) disease symptoms or abnormal ECG. Liver function tests. Improved liver histological appearance. Non-alcoholic fatty Consider abdominal ultrasound scan if LFT increased, Potential regression of established liver disease. liver disease specifically to detect fibrotic liver disease. Obstructive sleep Screening questionnaire (e.g. STOP-BANG) to identify Significant improvement in apnoea-hypopnoea index. apnoea and asthma those at risk for OSA. Remission of OSA in some cases. Excessive daytime Refer to sleep specialist if STOP-BANG score sleepiness and sleep Remarkable improvements in sleepiness and sleep quality quality despite continued OSA Ching Lee, P. and J. Dixon (2017). Aust Fam Physician 46(7): Choice of procedure should be an informed choice made by the patient All have their advantages and disadvantages: Risk v Benefit Adjustable gastric band Sleeve Gastrectomy Roux-en Y gastric bypass Surgery is a therapy for obesity and its complications We have no cures! Chronic Care Management Model 1. Community Resources and Policies 2. Health System Young Older High risk Control wt loss BMI >50 Skilled aftercare Current fashion But no specific patient selection criteria Major GO reflux Older Higher BMI Type 2 diabetes History of substance abuse Type 1 diabetes Depression Right thing Right patient Right time Informed, Activated Patient Productive Interactions Improved Outcomes 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. This is where YOU become important as long-term of care is critical to optimise results Monitor weight Lifestyle Medications Supplements Complications When did you last attend for review with someone who cares? Monitor lifestyle adherence and address issues Medications Avoid NSAIDS Adjust medication as appropriate do not assume treatments for ANY chronic conditions can stop Diabetes avoid hypoglycaemia Have a preference for medication that are weight friendly Drugs with narrow therapeutic index All patients who have has surgery required micronutrient supplements indefinitely Adult multivitamin and multimineral. (containing iron, folic acid, thiamine, vitamin B12). Doses: two daily for LSG/RYGB, one daily for LAGB. Citrated calcium (elemental calcium mg/day). Vitamin D, titrate to 25-OH vitamin D levels >30ng/mL. Typical dose required 3000 IU/day. Following LSG/RYGB Additional iron and vitamin B12 supplementation as required, based on lab results. Routine laboratory assessments Full blood count, urea & electrolytes, liver function tests, uric acid, glucose, lipids (every 6-12 months) 25-OH vitamin D, ipth, calcium, albumin, phosphate, B12, folate, iron studies (annually, more frequently if deficiencies identified) A summary of more common nutritional concerns for each procedure LAGB Sleeve G RYGB BPD BPD-DS Iron Thiamine Vitamin B Folate Calcium Vitamin D Protein Fat Soluble Vitamins and Essential Fatty Acids Recommended daily intake (allowance) or standard multivitamin preparation likely to be sufficient ++ Significant risk of deficiency or increased requirements. Specific supplementation is appropriate especially in higher risk groups +++ High risk of deficiency. Additional specific supplementation is necessary to prevent deficiency. Careful monitoring is recommended. Supplementation well in excess of daily requirements may be necessary. 5

6 Red flags that require review by bariatric MDT Obes Surg Aug;20(8): Abdominal pain: Acute or chronic Early or late Obstructive symptoms: Regurgitation, vomiting, persistent reflux especially with abdominal pain Anaemia Neuropathy or any neurological disturbance Persistent weakness or generalized pain Syncopal episodes or symptoms of hypoglycaemia Excessive (rare) Poor These patients need early referral back Excessive weight regain to the surgical team. If referred to alternative specialists or public hospitals Maladaptive eating please contact the patients bariatric Disordered eating surgeon or their replacement. No review for 12 months or more Flag ALL of your post B-M surgical patients review them personally every 12 months send reminders. The majority of patients are not seeing the MDT after 2 years and few at 10 years Do you want (your patients) to age well? Body composition Frailty - poor muscle strength Falls and fractures Mobility Activities of daily living Neuropathy We give our patients an opportunity let s not blow it! The health economics of B-M Surgery The are several perspectives that have been examined ICER cost per quality adjusted life years obtained Strictly from a cost of care perspective. Costs with and without having surgery and at times this can be restricted to limited health costs o Randomized trials o Propensity matched groups from managed care data bases. But broader economic costs of absenteeism, presenteeism, productivity and carer costs overlooked All studies find the accepted procedures cost-effective or dominant (cost saving) Surgery is cost effective and may provide a return on investment? Cost-effectiveness Relative to conventional therapy, surgically therapy associated with mean healthcare savings of AUD2, additional QALYs per patient Dominant (Not possible to calculate ICER) Threshold analysis Surgical therapy Cost-effective mean duration of remission 2 years, Dominant mean duration of remission 10 years Keating, C. L., et al. (2009).Diabetes Care 32(4): Keating, C. L., et al. (2009). Diabetes Care 32(4): Less effective More costly Less costly Most new interventions, recommended if <$50,000/QALY More effective Dominant - Rare, most compelling result for implementation on economic grounds. The Private vs Public divide is clearly evident and a global outlier What is equity? Equity is a term which describes fairness and justice in health outcomes. It s about recognising diversity and disadvantage, and directing resources and services towards those most in need, to ensure equal outcomes for all. Kylie Stephens Health promotions Weight loss surgery in Australia , AIHW Whitehead, M. The concepts and principles of equity and health, WHO, p8; The Equity Triangle Tool, VicHealth (2008) 6

7 Bariatric Metabolic Surgery Sustained Stunning safety profile A shock Sustained complication and risk change QOL and psychosocial outcomes Reduced mortality Health economic YES and return on investment? Issues of equity and chronic disease follow-up Think about those where this is the treatment of choice Flag all of your post B-M patients for regular review 7