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MISS Journal Club 2012 RYGB/BPD-DS

MISS Journal Club 2012 RYGB/BPD-DS Goal: to review 4 important and clinically relevant papers from 2011 on Gastric Bypass & BPD-DS. Article #1. Diabetes Care. 2012 Jan; 35 (1): 42-46. Objective.

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MISS Journal Club 2012 RYGB/BPD-DS

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  1. MISS Journal Club 2012 RYGB/BPD-DS Goal: to review 4 important and clinically relevant papers from 2011 on Gastric Bypass & BPD-DS

  2. Article #1 Diabetes Care. 2012 Jan; 35 (1): 42-46

  3. Objective GLP-1 levels and incretin effect on insulin secretion accounts for improved glycemic control after Gastric Bypass (GB) Long-term effect of GB is variable - diabetes re-emerges in up to 30% Aim: To characterize the magnitude & variance of the change of glucose & GLP-1 concentrations, and to identify determinants of glucose control, up to 2 years after GB

  4. Methods N=15 14 female T2DM for 2.5 ± 2.5 years HbA1c 7.1 ± 1.1% BMI 43.7 ± 4.9 age 47.5 ± 9.1 years Evaluated preop and 1, 12, and 24 months after GB Underwent a 50 g 3-hr OGTT followed by an isoglylcemic iv glucose challenge (isoG IVGT) Assessed mean changes and variances of each parameter

  5. Results

  6. Results cont.

  7. Results cont.

  8. Results cont.

  9. Results cont. Univariate analysis Changes in glucose AUC over time were positively associated with weight loss and negatively associated with HOMA-B and ISI composite Multivariate analysis weight loss, HOMA-B, and ISI were determinants of glucose AUC GLP-1 AUC was positively related to Insulin AUC

  10. Discussion

  11. Article #2 Archives of Surgery 2012; Jan 16.

  12. Background 17 RYGB vs. LAGB comparative studies to date 2 RCTs (Nguyen NT et al, Angrisani L et al) 3 case-matched studies 12 others Many methodological flaws in these studies Small numbers, different patient populations Current study aim: compared RYGB to LAGB in matched pairs, treated during same time period, by same surgeons

  13. Methods Inclusion criteria BMI <50 Primary bariatric surgery only, no revisional cases Min of 6 years follow-up (OR date <2005) RYGB and LAGB cases matched according to BMI Sex Age

  14. Methods LAGB: LAP- BAND (BioEnterics) or Swedish Adjustable Gastric Band (SAGB) RYGB: retrocolic/retrogastric, 10-15mL pouch, ‘short’ BP limb, 100cm Roux limb Follow-up schedule: LAGB monthly x 6 months, q2 months for 6 months, q3 months in Yr 2, q6 months thereafter band adjustments prn, Barium studies q18-24 months RYGB 1 month, q3 months for Yr 1, q6 months thereafter Labs annually, QoL assessment, food tolerance questionnaire

  15. Outcome measures Weight loss: ‘Excellent’ residual BMI <30 ‘Acceptable’ residual BMI <35 ‘Failure’ EWL<25% or residual BMI >35 Early (<30 days) & late (>30 days) complications Reoperations

  16. Results N=442 221 LAGB patients vs. 221 RYGB patients Comparable sex ratio, age, BMI Follow-up rate @ 6 years: 92.8% post-LAGB and 91.9% post-RYGB

  17. Results Weight loss Maximal weight loss: LAGB: @ 36 months …64.8% EWL RYGB: @ 18 months …78.5% EWL p<0.001

  18. Results Failures (EWL<25%, BMI>35, or need for reversal/conversion) 3 years post-op LAGB 31.7% RYGB 6.9% 6 years post-op LAGB 48.3% RYGB 12.3% p<0.001 p<0.001

  19. Results • No mortality in either group • Early complications: • RYGB 17.2% • LAGB: 5.4% ...... p<0.001 • Major morbidity (technical complications): • RYGB 3.6% • LAGB: 2.2% ...... p=0.54 • Long-term complications/reoperations • RYGB 19.0% / 12.7% • LAGB: 41.6% / 26.7% ...... p<0.001

  20. Results

  21. Results Overall, band removal necessary in 21.3% (n=47) …of whom 13.1% (n=29) underwent a further bariatric procedure

  22. Results Quality of life Improved in both groups Quicker & greater improvement after RYGB Food tolerance Better after RYGB Worsened over time after LAGB

  23. Results Comorbidity improvement Lipid profile:

  24. Discussion

  25. Article #3 Ann Intern Med 2011; 155(5):281-91.

  26. Gastric bypass (RYGB) vs. Duodenal Switch (DS) Uncontrolled studies suggest that DS induces greater weight loss than RYGB Prachand et al, Ann Surg 2006 Marceau et al, Obes Surg 2007 No RCT comparing these procedures Aim To conduct a randomized trial comparing RYGB vs. DS in super-obese (BMI>50) …w.r.t. weight loss, CVD risk factors and QoL Background

  27. Unblinded prospective randomized trial 2 academic medical centers (Norway & Sweden) N= 60 (RYGB=31, DS=29)* Follow-up 2 years Inclusion criteria: BMI 50-60 Age 20-50 years Failed non-surgical weight loss attempts Exclusion criteria: Previous bariatric or major abdo surgery Severe cardiopulmonary disease, cancer, steroids Methods - Computer-derived - Patient & surgeon masked to treatment allocation until 1wk prior to surgery * Power calculation performed, based on retrospective data: needed minimum of 26 pts in each group to give 80% power to detect a significant difference in outcomes

  28. Methods Techniques Standardized Laparoscopic techniques RYGB 25ml pouch, 50 cm BP limb, 150 cm Roux limb, linear stapler DS One-stage, Sleeve (30-32 F bougie), 100 cm common channel, 200 cm alimentary limb, hand-sewn DI anastomosis Mesenteric defects not closed in either procedure Routine postop diet Follow-up: same for both procedures (phased diet, vitamins, ursodiol) Clinical follow-up @ 6 weeks, 6 months, 1 year, 2years

  29. Methods Primary end-point Change in BMI @ 2 years Secondary end-points CV risk factors Health-related QoL (SF -36) Body composition (bioelectrical impedance analysis) Vitamin concentrations Adverse events

  30. Results

  31. Results Baseline characteristics … Similar for both groups Data in mean ± 2SD, unless stated as %

  32. Results Weight loss at 2 years • DS was associated with greater weight loss p<0.001 Mean Wt loss: RYGB: 50.6kg DS: 73.5kg

  33. Results Body composition Significant reductions in both groups [RYGB vs. DS] Waist circumference: ↓36.7 cm vs. ↓51.5 cm, p<0.001 Hip circumference: ↓31.7 cm vs. ↓45.6 cm, p<0.001 Sagittal diameter: ↓11.8 cm vs. ↓14.6 cm, p<0.001 All measure were significantly greater in DS group DS patients lost significantly more fat mass and fat-free mass

  34. Markers of CV risk Blood pressure Cholesterol Fasting glucose Insulin levels CRP level Generally improved in both groups @ 2 yrs DS led to greater improvement in TC, LDL and HDL levels Results

  35. Adverse events DS group had significantly more adverse events overall, compared to RYGB group Overall complications … 62% vs. 32%, p=0.021 Late (>30-day) complications … 41% vs. 29%, p=0.320 Results

  36. Results

  37. Results Vitamin concentrations • DS had lower Vitamin A and Vitamin D concentrations @ 2 yrs Health-related QoL • RYGB: 7 of 8 subscores of SF-36 improved at 2 yrs • DS: 5 of 8 subscores of SF-36 improved at 2 yrs

  38. Discussion

  39. Article #4 Diabetes Care 2011; 34(3):561-567

  40. Background Intensive glycemic control, achieved medically, does not reduce CV events in patients with well established DM Actually assoc with higher mortality (ACCORD trial, PROactive trial) <50% Diabetics are well controlled (ADA) Buchwald meta-analysis 2009: Bariatric surgery led to remission/improvement of DM in 78%/87% BPD superior to RYGB Authors have previously published high DM remission rates after BPD. No long term follow-up available

  41. Aim To assess the effect of BPD vs. Conventional Medical Therapy on diabetic complications

  42. Methods Longitudinal case-control study, not randomized Single center (Rome) N=110 obese patients (BMI>35), aged 25-60 years* All had newly diagnosed T2DM (FBG >7.0mmol/L x2, or positive OGTT) 10 years follow-up BPD & Conservative therapy groups matched for: Gender Age BMI Cholesterol & Triglyceride levels Smoking status * Power calculation performed to calculate appropriate sample size …needed 30 in each group to give 90% power to detect a ΔGFR of 25%

  43. Methods Exclusion criteria: CV event in 6 months prior to enrollment Advanced CCF Severe angina Creatinine >1.6mg/dL Malignancy Portal HTN ‘Run-in’ period – all subjects went on 3 month low cal diet prior to study group allocation ‘Conservative’ treatment – Sulphonylurea or insulin and/or metformin, supervised by a Diabetologist BPD – Open,

  44. Methods End-points Primary % variation in GFR Secondary Incidence of nephropathy, HTN, hyperlipidemia, CV events % recovering from T2DM over 10 years follow-up Change in weight, HbA1C, glucose, lipid profile, BP, Framingham risk score Change in insulin sensitivity measured only in BPD group

  45. Results 110 enrolled, only 50 met inclusion criteria/entered treatment groups after 3 month diet Baseline characteristics similar in both groups

  46. Results Early complications: N=2 (9.1%) in BPD group Respiratory infection n=1 Wound infection n=1 Late complications: N=5 (22.7%) in BPD group Incisional hernia n=3 Marginal ulcer n=2

  47. Results Diabetic complications Nephropathy (relative % variation in GFR): Deteriorated in controls (-45.6 ± 18.7%) Marginally improved in BPD group (+4.2 ± 31.3%) % pts with microalbuminuria

  48. Results Progression from no nephropathy at study entry, to nephropathy at 10 yrs: BPD group 9% Controls 50% p=0.002

  49. Results CV events BPD group n=0 Controls n=4 (3 MI’s, one stroke) CV risk

  50. Results Hypertension Hyperlipidemia Diabetes recovery Prevalence

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