6/10/2016. Bariatric Surgery: Impact on Diabetes and CVD Risk. Disclosures BARIATRIC PROCEDURES

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1 Bariatric Surgery: Impact on Diabetes and CVD Risk Anthony M Gonzalez, MD, FACS, FASMBS Medical Director Bariatric Surgery, South Miami Hospital Chief of Surgery, Baptist Hospital of Miami Associate Professor of Surgery, FIU College of Medicine Disclosures Intuitive Surgical- Epicenter, Proctor, Consultant, Grant Recipient Ethicon- Consultant, Proctor MID (Floshield)- Scientific Advisory Board, Grant Recipient Mallinkrodt/ Cadence- Speakers Bureau BARIATRIC PROCEDURES 1

2 Weight-loss Surgery Options 2

3 Newer Options United States 3

4 Outcomes 4

5 CMS: Inpatient Discharge Data (2010) Morbidity & mortality rates of gastric bypass are similar to other common procedures Source: Direct Research, LLC, Center for Medicare and Medicaid Services, FY 2010 MedPAR, Medicare Fee-for-Service Inpatient Discharges with Selected Procedures UHC Database: Surgery Data (2012) Morbidity & complication rates of laparoscopic bariatric surgery are similar to other laparoscopic general surgery procedures Outcomes of laparoscopic procedures in general surgical operations between 2006 and 2009 Operations N Utilization of laparoscopy LOS* (days) Complications* Mortality* Bariatric surgery 54, % 2.3 ± % 0.06% Cholecystectomy 54, % 3.3 ± % 0.18% Antireflux surgery 8, % 2.9 ± % 0.02% Appendectomy 51, % 1.6 ± % 0.02% Colectomy 21, % 5.6 ± % 0.54% Ventral hernia repair 25, % 3.2 ± % 0.24% Rectal resection 2, % 6.9 ± % 0.57% Outcome of laparoscopic operations; LOS: length of stay Source: Nguyen B, Richardson JF, Smith B et al. Utilization of laparoscopy in general surgical operations at academic centers ASMBS Abstracts. PL-106. BARIATRIC SURGERY & DIABETES 5

6 Cleveland Clinic study Schauer PR et al.: Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. NEJM 2012 Jan. 2 Cleveland Clinic study Schauer PR et al.: Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. NEJM 2012 Jan. 2 STAMPEDE Surgical treatment and medications achieved glycemic control in more patients than medical therapy alone. Schauer PR, Kashyap SR, Wolski K, et al. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. N Engl J Med. 2012; 366:

7 STAMPEDE Study Design * As defined by ADA guidelines, including lifestyle counseling, weight management, frequent home glucose monitoring, and the use of newer drug therapies. STAMPEDE Results: Significantly More Diabetic Patients at Glycemic Control* with Bariatric / Metabolic Surgery In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Patients at Glycemic Control*, 12 months 45% 40% 35% 30% 25% 20% 15% 42% * 37% ** 10% 5% 12% 0% Medical Therapy Medical Therapy + Gastric Bypass *p=0.002 Medical Therapy + Sleeve Gastrectomy **p=0.008 *Glycemic control: HbA1c < 6.0% with or without diabetes medications, 12 mo after randomization. Figures adapted from study data. STAMPEDE Results: Average levels of HbA1c were also significantly lower after Bariatric / Metabolic Surgery Mean levels of glycated hemoglobin and fasting plasma glucose were significantly lower in each of the two surgical groups than in the medical therapy group (p<0.001). 7

8 STAMPEDE Results: Significant Decreases in Diabetic Medication Usage with Bariatric / Metabolic Surgery The average number of diabetic medications per patient per day tended to increase in the medical therapy group but decreased significantly in each surgical group (p<0.001): > 50% of patients in each surgical group used NO diabetes medications at 12 months. Italian study Mingrone G et al.: Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes. NEJM 2012 Jan. 2 Systematic Review & Meta-Analysis Buchwald (2009) T2DM resolved or improved in 87% of patients following bariatric surgery 100% 80% 60% 40% 20% 87% 87% 85% 81% 99% 0% Total Gastric Banding Resolved Gastroplasty Gastric Bypass Resolved or Improved BPD/DS Systematic review & meta-analysis reviewing 621 studies including 135,246 patients Overall, T2DM 87% resolved or improved (78% resolved) for patients after bariatric surgery Buchwald H, Estok R, Farbach K, et al. Weight and Type 2 Diabetes after Bariatric Surgery: Systematic Review and Meta-analysis. Am J Med. 2009;122(3): Figure adapted from source data. Data included includes 621 studies with 888 treatment arms & 135,246 patients; 103 treatment arms with 3188 patients reported on resolution of diabetes. 8

9 Swedish Obese Subjects (SOS) Bariatric surgery appears to be markedly more efficient than usual care in the prevention of Type 2 diabetes in obese persons. Carlsson LMS, Peltonen M, Ahlin S et al, Bariatric Surgery and Prevention of Type 2 Diabetes in Swedish Obese Subjects. N Engl J Med 2012; 367: SOS Study Carlsson et al. Study Design SOS Study Carlsson et al. Results: Significantly lower incidence of Type 2 Diabetes in Bariatric / Metabolic Surgery group 9

10 CLINICAL EVIDENCE BARIATRIC / METABOLIC SURGERY AND DIABETES MANAGEMENT IN LOW BMI (BMI 30-35) Cohen: 5-Year Study of Diabetic Patients (2012) 88% of diabetic patients without severe obesity showed diabetes remission Study of 66 consecutive diabetic patients with BMI who underwent RYGB. At median 5 years, durable diabetes remission occurred in 88% of cases, and diabetes improvement in an additional 11%. There was no recurrence of diabetes following remission during [the] six-year follow-up. Hypertension and dyslipidemia also improved, yielding 50-84% reductions in predicted 10-year cardiovascular disease risks of fatal and nonfatal coronary heart disease and stroke. Source: Cohen RV, Pinheiro JC, Schiavon CA et al. Effects of gastric bypass surgery in patients with type 2 diabetes and only mild obesity. Diabetes Care 2012; 35: Summary of Metabolic Surgery 10

11 Metabolic Surgery has. Helped Type 2 Diabetes patients achieve glycemic control more effectively than intensive medical therapy at 1 year (STAMPEDE & Mingrone) Resolved or Improved Type 2 Diabetes and other obesity related CV comorbidities for up to 5 years (STAMPEDE, Buchwald, Klein & Bolen) Reduced Medication use for Type 2 Diabetes and other CV Comorbidities for up to 3 years (STAMPEDE, AHRQ/Segal & Klein) Was more efficient than usual care for the prevention of Type 2 Diabetes in persons with obesity at 15 years (SOS) BARIATRIC SURGERY & CVD Sjostrom et al. (2012) Bariatric Surgery Prevents CV Events High insulin may be a better selection criteria for bariatric surgery than high BMI, as far as CV events are concerned Sjostrom, L et. al., Bariatric Surgery and Long-term Cardiovascular Events. JAMA 2012; 307(1):

12 Incidence of Fatal & Total CV Events Sjostrom, L et. al., Bariatric Surgery and Long-term Cardiovascular Events. JAMA 2012; 307(1):56-65 Hazard Ratio of MI, Stroke with Surgery Sjostrom, L et. al., Bariatric Surgery and Long-term Cardiovascular Events. JAMA 2012; 307(1):56-65 Segal: AHRQ 1-Year Cohort Study (2010) Significant declines in cardiovascular medication use at 12 months post-surgery Use of medication for hypertension & hyperlipidemia declined 51% and 59%, respectively, at 12 months post-surgery(p<0.0001) Patients without surgery had an increase in medications for hypertension and hyperlipidemia Source: Segal JB, Clark JM, Shore AD, et al. Prompt reduction in use of medications for comorbid conditions after bariatric surgery. Effective Healthcare Research Report No. 28. Rockville, MD: Agency for Healthcare Research and Quality; (Fig 1, page 14) 12

13 What Should be the Focus? Bariatric / metabolic surgery can achieve better control of Type 2 diabetes with much less medication in select obese patients (BMI>35) o Focus on those patients who are at highest risk of a CV event: Younger (under 60) Treated less than 10 years Difficulty maintaining glycemic control with pharmacological agents. Having at least one other CV risk factor in addition to T2DM, e.g. elevated insulin, hypertension and/or dyslipidemia. Difficulty maintaining acceptable weight (almost all T2DM patients). o Surgery is a therapeutic intervention, not just for severely obese patients. o Mode of action of bariatric surgery is metabolically analogous to many T2DM medications with positive impact on GLP-1 & insulin sensitivity. Sjostrom, L and others. Bariatric Surgery and Long-term Cardiovascular Events. JAMA 2012; 307(1): Berry, J. and others. Lifetime Risks of Cardiovascular Disease. NEJM 2012; 366: Summary Obesity & its associated Mortality Increasing Procedure Types & Volumes Increasing Surgical Weight loss maintained at 10 years Metabolic Surgery has demonstrated Improvements in Glycemic Control in Diabetics Metabolic Surgery can Prevent Diabetes in Obese patients Bariatric Surgery has been demonstrated to reduce CV Events Thank You 13

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