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  1. BARIATRIC (METABOLIC) SURGERY FOR LIFE-LONG WEIGHT CONTROL AND REMISSION OF ASSOCIATED CHRONIC DISEASES – A METAANALYSIS OF PUBLISHED CLINICAL PAPERS TO-DATE Henry Buchwald, M.D., Ph.D. University of Minnesota

  2. DISCLOSURES • Henry Buchwald, MD, PhD • Consultant or Research Support • Ethicon Endo-Surgery • MetaCure • W.L. Gore

  3. BARIATRIC SURGERY: A REVIEW AND METAANALYSIS • Henry Buchwald, MD, PhD, University of Minnesota • Yoav Avidor, MD, Ethicon Endo-Surgery, Inc. • Eugene Braunwald, MD, Harvard Medical School • Michael D. Jensen, MD Mayo Clinic • Walter Pories, MD, East Carolina University • Kyle Fahbach, PhD, MetaWorks • Karen Schoelles, MD, MetaWorks • JAMA 2004;292:1724-1737

  4. OBJECTIVES • Primary – To determine the impact of bariatric surgery on 4 of the major obesity comorbidities: diabetes, hyperlipidemia, hypertension, and obstructive sleep apnea. • Secondary – To determine the weight loss and operative mortality in the studies selected for review and metaanalysis.

  5. METHODS • Broad electronic search of the English-language literature, 1990-2003, using MEDLINE, Currents Contents, and the Cochran Library databases. • Manual reference checks. • Two levels of screening.

  6. METHODS: LEVEL 1 SCREENING • Abstract review, exclusion criteria: • Publication of abstract only • Case reports • Letters • Comments • Reviews • Animal or in vitro studies • Fewer than 10 patients • Follow-up less than 10 days • Language other than English • No surgical intervention • Intragastric balloon therapy (experimental)

  7. METHODS: STATISTICAL ANALYSIS • A random effects model was used for the metaanalysis (results expressed as means and CIs). • Weighted means were used for a non-metaanalytic comparison.

  8. RESULTS: DATA RETRIEVAL • 2738 citations identified 1772 studies rejected prescreening 961 studies retrieved 253 Studies rejected by screening 708 studies 572 studies for catalog only 136 studies (91 kin) qualifying for metaanalysis

  9. RESULTS: STUDIES SELECTED • Total: 134 primary studies (2 health care economics studied excluded from 136 for no efficacy or mortality data) (179 study groups, 22,049 patients) • 5 randomized controlled trials (9 study groups, 621 patients) • 28 nonrandomized controlled trials (48 study groups, 4,613 patients) • 101 uncontrolled case series (122 study groups, 16,860 patients)

  10. RESULTS: STUDY CHARACTERISTICS • 56 studies North America • 58 studies Europe • 20 studies elsewhere

  11. RESULTS: PATIENT CHARACTERISTICS • Gender: 19% men • 73% women • 8% not reported • Age:x 39 (range, 16-64) • Baseline BMI:x 46.85 (range, 32.30-68.80)

  12. RESULTS: WEIGHT LOSS • Total Population: • % EWL: 61.2% (95% CI, 58.1 - 64.4)  BMI: 14.2 kg/m2 (95% CI, 13.3 - 15.1)  Absolute Weight: 39.7 kg (95% CI, 37.2 – 42.2) All weight loss reductions p < 0.001

  13. RESULTS: WEIGHT LOSS • Surgical Groups % EWL (95% CI): • Gastric Banding 47.5% (40.7 – 54.2) • Gastric Bypass 61.6% (56.7 – 66.5) • Gastroplasty 68.2% (61.5 – 74.8) • Biliopancreatic Diversion/ Duodenal Switch 70.1% (66.3 – 73.9) • All weight loss reductions p < 0.001

  14. RESULTS: OPERATIVE MORTALITY ( 30 DAYS) • Purely restrictive0.1% • (n=2,297 gastric banding, n=749 gastroplasty) • Gastric Bypass0.5% • (n=5,644) • Biliopancreatic diversion/duodenal switch1.1% • (n=3,030)

  15. RESULTS: OUTCOMES – DIABETES • Total Population With Diabetes: • Resolution 76.8% (70.7-82.9) • Resolution or Improvement 86.0% (78.4-93.7) • Reduction FBG 13.33 mg/dL (10.81-15.86) • All values p < 0.01

  16. RESULTS: OUTCOMES – DIABETES • Surgical Groups % Resolution: • Gastric Banding 47.9% (29.1-66.7) • Gastroplasty 71.6% (55.1-88.2) • Gastric Bypass 83.7% (77.3-90.1) • Biliopancreatic Diversion/ Duodenal Switch 98.9% (96.8-100) • All values p < 0.01

  17. RESULTS: OUTCOMES – HYPERLIPIDEMIA • Patients Improved With Hyperlipidemia: • Total Population 79.3% (68.2-90.5) • Gastric Banding 58.9% (28.2-89.6) • Gastroplasty 73.6% (60.8-86.3) • Gastric Bypass 96.9% (93.6-100.0) • Biliopancreatic Diversion/ Duodenal Switch 99.1% (97.6-100.0) • All values p < 0.01

  18. RESULTS: OUTCOMES – HYPERLIPIDEMIA • Total Population With Hyperlipidemia: • Total CholLDL-CholHDL-CholTriglycerides • Change -33.20 mg/dL -29.34 mg/dL 2.70 mg/dL 79.65 mg/dL • CI 23.17-43.63 17.76-40.93 0-5.79 64.60-95.58 • p value <0.01 < 0.01 < 0.1 <0.01

  19. RESULTS: OUTCOMES - HYPERTENSION • Total Population With Hypertension: • Resolution 61.7% (55.6-67.8) • Resolution or Improvement 78.5% (70.8-86.1) • All values p<0.01

  20. RESULTS: OUTCOMES – OBSTRUCTIVE SLEEP APNEA • Total Populations With Obstructive Sleep Apnea: • Resolution 85.7% (79.2-92.2) • Resolution or Improvement 83.6% (71.8-95.4) • Apneas or Hypopneas -33.85/hr (17.47-50.23) • All values p<0.01

  21. SUMMARY • Review and metaanalysis of 136 studies involving 22,094 patients. • Results: • x % EWL 61.2% • x Operative ( 30 days) Mortality 0.1-1.1% • Resolution of Diabetes 76.8% • Resolution of Hyperlipidemia 79.3% • Resolution of Hypertension 61.7% • Resolution of Obstructive Sleep Apnea 85.7%

  22. CONCLUSION • A substantial majority of morbidly obese patients with diabetes, hyperlipidemia, hypertension, and/or obstructive sleep apnea have total resolution or marked improvement of their comorbid conditions after bariatric surgery.

  23. EFFECTS OF BARIATRIC SURGERY ON TYPE 2 DIABETES: A SYSTEMATIC REVIEW AND METAANALYSIS • Henry Buchwald, MD, PhD,1 Rhonda Estok, RN, BSN,2 • Kyle Fahrbach, PhD,2 Deirdre Banel, BS,2 • Michael D. Jensen, MD,3 Walter Pories, MD,4John Bantle, MD,1 Isabella Sledge, MD, MPH2 • 1University of Minnesota, Minneapolis, MN; • 2United BioSource Corporation, Medford, MA; • 3Mayo Clinic College of Medicine, Rochester, MN; • 4East Carolina University School of Medicine, Greenville, NC • Am J Med 2009;122:248-256

  24. DIABETES METAANALYSIS • GOAL: To determine the impact of bariatric surgery procedures on type 2 diabetes mellitus in association with the weight reduction achieved.

  25. DIABETES METAANALYSIS • METHODS: • Screening of all papers published in English, from January 1, 1990 to April 30, 2006, identified through electronic searches in MEDLINE, Current Contents, and the Cochran Library, supplemented by manual reference checks. • All accepted studies were assigned a level of evidence (Centre for Evidence-Based Medicine, Oxford, UK), and randomized controlled trials were rated for quality by the Jadad scoring method.

  26. DIABETES METAANALYSIS • METHODS: • Restricted, maximum likelihood, random-effects metaanalyses (REM) were performed and heterogeneity was assessed using Cochran’s Q statistic. • Diabetes outcomes assessed for <2 years and 2 years.

  27. DIABETES METAANALYSIS • RESULTS: Data Set • 621 studies (136 in 2004) • 888 treatment arms (179 in 2004) • 135,246 patients (22,094 in 2004)

  28. DIABETES METAANALYSIS • RESULTS: Study Characteristics • Study Location • Europe 44.4% • North America 43.2% • Australia/New Zealand 3.5% • South America 3.1% • Asia 1.5% • Others 4.5%

  29. DIABETES METAANALYSIS • RESULTS: Patient Characteristics – • Total • Mean Age 40.2 years • Mean BMI 47.9 kg/m2 • Gender Male 19.9% • Female 79.6% • Type 2 Diabetes 22.3%

  30. DIABETES METAANALYSIS • RESULTS: • Weight Reduction Metaanalysis% EBWL • Overall • TotalGastric BandingGastroplastyGastric BypassBPD/DS • 55.9 46.2 55.5 59.5 63.6

  31. DIABETES METAANALYSIS • RESULTS: Diabetes Outcomes Metaanalysis • Overall

  32. DIABETES METAANALYSIS • RESULTS: Diabetes Outcomes Metaanalysis • < 2 Years

  33. DIABETES METAANALYSIS • RESULTS: Diabetes Outcomes Metaanalysis •  2 Years

  34. DIABETES METAANALYSIS • RESULTS: Diabetes Outcomes Metaanalysis Diabetic Patients OnlyOverall

  35. DIABETES METAANALYSIS • RESULTS: Diabetes Outcomes Metaanalysis • Patients Resolved Associated With Weight Reduction Achieved and Procedure Performed

  36. DIABETES METAANALYSIS • STRENGTHS OF THE STUDY • The data set is global, comprehensive, and as inclusive as possible, limited only by a predetermined time span. • The selection criteria are independent of outcomes and, therefore, to a large extent, eliminate selection bias. • The derived metabolic data are weighted by the number of study patients, as well as by the variability among studies.

  37. DIABETES METAANALYSIS • WEAKNESSES OF THE STUDY • It is impossible to extrapolate the effects on outcomes of missing – unreported – data from good and from bad series. • There is limited reporting of longer-term diabetes data.

  38. DIABETES METAANALYSIS • SUMMARY • Bariatric surgery causes resolution of type 2 diabetes: • 78.1% in entire metaanalysis • 79.3% in diabetic patients only cohort. • Bariatric surgery causes resolution or improvement of type 2 diabetes: • 86.6% in entire metaanalysis • 98.9% in diabetic patients only cohort

  39. DIABETES METAANALYSIS • SUMMARY • The resolution and resolution or improvement of type 2 diabetes is associated with the degree of weight reduction achieved and, thereby, the bariatric procedure performed: • Adjustable gastric banding < gastroplasty < gastric bypass < BPD/DS in entire metaanalysis • Adjustable gastric banding < gastric bypass < BPD/DS in diabetic patients only cohort • Weight and diabetes parameters showed little difference at <2 years and 2 years; thus, these effects appear to be lasting.

  40. DIABETES METAANALYSIS • SUMMARY • Insulin, HgA1c, and fasting glucose values declined substantially after bariatric surgery, giving laboratory metabolic substantiation to the clinical findings.

  41. DIABETES METAANALYSIS • CONCLUSION • Bariatric surgery is effective therapy for type 2 diabetes.

  42. BARIATRIC SURGERY WORLDWIDE 2008 • Henry Buchwald, MD, PhD • Professor of Surgery and Biomedical Engineering • University of Minnesota • Minneapolis, MN, USA • Obes Surg 2009; 19:1605-1611

  43. RESULTS: QUESTION #1 Country

  44. RESULTS: QUESTION #2 Country

  45. RESULTS: QUESTION #3 Bariatric surgery procedures worldwide Lap.=laparoscopic VBG=vertical banded gastroplasty RYGB=Roux-en-Y gastric bypass LL=long-limb

  46. RESULTS 2008

  47. RESULTSTRENDS: 2003 to 2008

  48. RESULTSTRENDS: 2003 TO 2008

  49. REGIONAL TREND EUROPE

  50. TRENDS: 2003 TO 2008EUROPE