10/16/2014. Normal Weight: BMI Overweight: BMI >25 Obese: BMI >30 Morbidly Obese: BMI >40 or >35 with 2 comorbidities

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1 Brinton Clark, MD, MPH Department of Medical Education Providence Portland Medical Center October 25 th, 2014 Oregon Society of Physician Assistants Fall Conference 45 yo woman with BMI=40kg/m2 (weight 278#) Diabetes on 55 units of lantus, 15 units of lispro QAC, exanitide, metformin. Hemoglobin A1C=9.2% Hypertension, hyperlipidemia, physically inactive with worsening back and leg pain. Obesity Trends Review of Bariatric Procedures Indications for Bariatric Surgery Medical Outcomes of Bariatric Surgery Complications Medical Management of Patients after Surgery Local Resources 1

2 Normal Weight: BMI Overweight: BMI >25 Obese: BMI >30 Morbidly Obese: BMI >40 or >35 with 2 comorbidities Obesity Trends* Among U.S. Adults BRFSS, 1990, 2000, 2010 (*BMI 30, or about 30 lbs. overweight for 5 4 person) No Data <10% 10% 14% 15% 19% 20% 24% 25% 29% 30% More than 1/3 of all US adults are obese 14.5% of US adults have BMI >35, 7% BMI>40 Estimated annual medical costs of obesity $ billion Medical costs $ higher per year for obese patients 2

3 Increased Mortality Cancer (endometrial, breast, Diabetes prostate, colon) Hypertension Gallbladder disease Dyslipidemia GERD Coronary Heart Disease NASH Congestive Heart Failure Osteoarthritis Thromboembolic Stroke Stress Incontinence Sleep Apnea Menstrual Irregularities and Restrictive Lung Disease Infertility Chronic Kidney Disease Psychosocial Approximately 200,000 surgeries/year in US Most common procedures are: Roux-en-Y Gastric Bypass (RYGB) Sleeve Gastrectomy (SG) Adjustable Gastric Banding (AGB) DeMaria EJ. NEJM 2007; 356:

4 DeMaria EJ. NEJM 2007; 356: DeMaria EJ. NEJM 2007; 356: Body Mass Index (BMI) >40 kg/m 2 BMI >35 kg/m 2 with >1 serious comorbidity Diabetes Obstructive sleep apnea or obesity hypoventilation Hypertension Hyperlipidemia Non-alcoholic fatty liver disease or steatohepatitis Debilitating arthritis Asthma Mechanick JI. Obesity 2013; 21: S1. 4

5 Excess body weight (EBW) = weight above ideal body weight at BMI of 25kg/M 2 RYGB: Approximately 60-80% EBW SG: 60-70% Excess Body Weight AGB: 40-60% Excess Body Weight Puzziferri et al. JAMA. 2014; 312: Diabetes Hypertension Hyperlipidemia OSA Mortality Quality of Life 5

6 Randomized, single center, non-blinded trial 150 patients with uncontrolled diabetes Baseline A1C 9.3%, avg diabetes for 8.3 years Average BMI 36 (included BMI 27-43) 3 year follow up of 137 patients (91%) Primary endpoint A1C of < 6.0% Schauer PR et al. NEJM; online March 31, 2014 Randomized, 4 centers (US, Taiwan), unblinded trial of 120 patients with diabetes Baseline A1C 9.6%, avg diabetes for 9 years Average BMI 34 kg/m2 ( ) 12 months follow up 114 patients (95%) Primary endpoint composite of A1C <7%, LDL cholesterol <100mg/dL, SBP <130mmHG Ikramuddin S. JAMA. 2013; 309:

7 Systematic Review of 6 studies: RYGB diabetes remission rate 66.7% AGB diabetes remission rate 28.6% Swedish Obesity Subjects Trial (prospective controlled trial) of subjects without diabetes: Diabetes developed in 6.8 cases per 1000 person-years vs 28.4 (adjusted hazard ratio 0.17) 3 1. Puzziferri N. JAMA. 2014; 312: Carlsson L. NEJM. 2012;367: Schauer 3 year RCT: Non significant difference in BP but significant reduction in # of meds needed 2 LABS Consortium Observational Cohort Study: Hypertension remission 38% RYBG, 17% ABG 3 1. Ikramuddin S. JAMA. 2013; 309: Schauer PR et al. NEJM. 2014; 370: Courcoulas AP. JAMA 2013; 310:

8 Systematic review 3 studies. Remission of hyperlipidemia 60.4% after RYGB, 22.7% after AGB 1. Schauer PR et al. NEJM. 2014; 370: Puzziferri N et al. JAMA. 2014; 312: Meta-analysis RCTs (3 studies, 41 pts) showed remission of OSA in 95% of pts with RYGB Meta-analysis observations trials (29 studies, 9844 pts) showed remission of OSA in 95% RYGB, 71% AGB, 91% SG Chang S-H. JAMA Surg; published online Dec 18, SOS Prospective Controlled Trial 4047 obese subjects followed on average 10.9 years, vital status known on all but 3 Unadjusted HR for death = 0.76 (surg vs control) Adjusted HR =0.71 Death from MI 13 vs 25 Death from cancer 29 vs 47 Sjostrom L. NEJM 2007; 357:

9 Perioperative mortality % Pulmonary embolism, anastomotic leaks Wound infections, bleeding, incisional and internal hernias, SBO, ulcers, strictures Nausea and vomitting after restrictive procedures (50%) Dumping syndrome Vitamin deficiencies Dietary changes Nutritional deficiencies Medications Contraception 9

10 Often start on full liquid diet in initial days with adequate protein. Diet gradually advanced to small, soft meals. Eat slowly and chew thoroughly. Stop eating once satiety reached. Gradually re-introduce regular foods in small amounts. Avoid a lot of liquid calories. Ideal protein intake 1-1.5g/kg ideal weight daily. Multivitamin with minerals to supplement vitamin A, B1, E, K, iron, folic acid, zinc, copper, selenium, biotin Calcium citrate mg/day Vitamin D3 800 units/day Iron supplement (beyond MVI) if deficient Vitamin B mcg daily Monitor progress with weight loss and any complications each visit Labs 3, 6 and 12 months then annually CBC, BMP, LFTs, Iron studies, B12, folate, Lipids, vitamin D 25-OH, PTH Thiamine, zinc, copper, selenium with specific findings 24 hour urine calcium at 6 mo and 1 year Bone density at 2 years 10

11 Diabetes: rapid changes in insulin/diabetes medication requirements. Require frequent monitoring and adjustment of meds. Adjust doses of anti-hypertensives Consider stopping medications for GERD Avoid enteric-coated or controlled-release medications (esp RYGB) Avoid NSAIDs post-operatively Fertility often increases after bariatric surgery Women counseled to delay pregnancy for months (during period of rapid weight loss) Malabsorption of oral contraceptives may reduce efficacy: non-oral forms recommended Evaluate for nutritional deficiencies before pregnancy Economic modeling using insurance databases and clinical studies Matched cohorts look at health care utilization for groups that undergo weight loss surgery vs medical interventions Incremental cost-effectiveness ratios (ICER) cost per QALY 11

12 British NHS: 20 year economic model predicts per QALY gained ($ ). US economic model based on 5 year post-op insurance data: ~$25,000 cost for bariatric surgery (2 mo post-op) Cost savings begin 3 months post-op Total surgery costs fully recovered by 53 months Australian Trial of diabetic patients - $1775 lifetime savings, 1.2 QALYs gained (3) 1. Picot J et al. Health Tech Assessment. 2009; Cremieux PY et al. Am J Managed Care. 2008; Keating C et al. Diabetes Care 2009; 32. Legacy Weight and Diabetes Institute OHSU Bariatric Surgery Program Salem Hospital Bariatric Surgery Center Oregon Bariatric Center PeaceHealth, Eugene Initial education session Evaluation by multi-disciplinary team (surgeon, dietician, physical therapist, psychologist, NP/PA) Typically process takes 2-6 months Follow up visits post surgery: 4-6 in first year then annually thereafter 45 yo woman with BMI=40kg/m2 (weight 278#) Diabetes on 55 units of lantus, 15 units of lispro QAC, exanitide, metformin. Hemoglobin A1C=9.2% Hypertension, hyperlipidemia, physically inactive with worsening back and leg pain. 12

13 Underwent RYGB March Weight over first year. BMI now 30. Diabetes Lantus down to 30 units and lispro 5 units QAC, off exanitide. A1C 7.7% (down 1.5%). Blood pressure under better control, 1 fewer medication Less pain, more physically active, now able to take foster children into her home. Thank you for your attention! 13