Latest Stomaphyx presentation

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Latest presentation on stomaphyx from my group at Beth Israel in New York

Latest presentation on stomaphyx from my group at Beth Israel in New York

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  • 1. Predictors of weight loss following endoluminal gastric pouch reduction after failed gastric bypass Elliot R. Goodman, M.D.* , David Bodansky, B.Med.Sc., Chiranjiv S. Virk, M.D., Burton Surick, M.D., John L. Holup, D.O., Daniel Rosen, M.D., I. Michael Leitman, M.D., Julie Ellner, M.D. , Sol Silverman *Department of Surgery Beth Israel Medical Center New York, NY
  • 2. Disclosures
    • StomaphyX is a product of EndoGastric Solutions, Inc., Redmond, WA
    • Dr. Goodman is a consultant to EndoGastric Solutions
    • Other authors have no commercial associations that might be of conflict in relation to the presented study
  • 3. Background
    • 150,000-200,000 bariatric operations done a year in the U.S.
    • 67-75% EWL in 80% of patients in 2 years
    • 95% of patients maintained at least 50% EWL at 12-year follow-up
    Pories WJ, Swanson MS, MacDonald KG. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg 1995;222:339-350.
  • 4. Background
    • Usually a nadir weight is reached at 2 years
    • Estimated 10%-20% of patients regain significant weight at 5-10 years
    • 12% of patients undergo surgical revision after gastric bypass surgery
    Gagner M., et al. Laparoscopic Reoperative Bariatric Surgery : Experience from 27 consecutive patients. Obes Surg, (12) 254-260, 2002.
  • 5. Background
    • Review of literature on re-operative bariatric surgery
      • 17 publications (838 patients)
        • 118 major complications (14%)
        • 11 deaths (1.3%)
      • 64 patients - laparoscopic reoperation
        • 6 major complications (9%)
        • Average OR time 4.5 hours
    Jones KB. Revisional bariatric Surgery-potentially safe and effective. SOARDS 1 (2005) 599-603
  • 6. Background
    • Weight regain after gastric bypass
      • Multifactorial causes
    • Indication of revisional surgery
      • exhaustion of medical, psychological and dietary efforts
  • 7. Complications of Revisional Surgery
    • Anastomotic leaks
    • Wound dehiscences
    • Incisional hernias
    • Pulmonary complications
    • Death
    • An effective endoscopic method may
    • avoids most of these complications
  • 8. Endoluminal Gastric Pouch Reduction Using StomaphyX (EGPRSx)
    • StomaphyX TM (EndoGastric Solutions):
    • Approved in the U.S. and Europe for tissue approximation and full-thickness plication in the GI tract
    • Patients who regained weight after gastric bypass and want another surgery for weight loss
    • Patients with rapid gastric emptying or dumping syndrome associated with diarrhea
  • 9. EGPRSx Click to play animation
  • 10. Objective
    • To conduct a retrospective data review of 197 consecutive patients treated at two institutions to determine potential predictors of successful weight loss one year after EGPRSx
  • 11. Patients & Methods
    • Selection criteria:
      • patients at least 2 years after original gastric bypass and had regained at least 20% of weight lost at nadir
    • Preoperative work up:
      • Upper endoscopy/ Upper GI swallow study.
    • Nutritional pre-op evaluation and post-op counseling on postoperative diet
  • 12. EGPRSx
    • Anesthesia: general endotracheal
    • Upper Endoscopy: to measure GE and GJ
    • Gastroscope and StomaphyX passed down esophagus as one unit
    • StomaphyX uses suction to draw gastric wall into device
    • First 5 patients had simultaneous laparoscopy to evaluate safety of plications
  • 13. EGPRSx Procedure
    • 7mm, 3-0 polypropylene fasteners
    • Typically 20-30 fasteners per case
    • Additional fasteners depending upon pouch size
    • Start 1 cm proximal to stoma at 6 o’clock
    • 1-2 cm proximal to first row 6 fasteners
    • OR time 35-130 minutes
  • 14. Baseline Characteristics Means ± SD
    • N treated 197 at two hospitals
    • N followed up 109 (55%)
        • 71 (36%) LFU; 17 (9%) no GB data
      • Gender 93% female
      • Age 49.8 ± 10.4 years
      • Weight 103.5 ± 18.5 kg
      • BMI 37.5 ± 6.1 kg/m 2
      • Excess weight 34.4 ± 16.5 kg
      • Regained weight (RW) 22.1 ± 12.0 kg
      • % RW 37 ± 22
      • Years after GB 7.2 ± 3.9
  • 15. Characteristics Pre and Post GB Means ± SD
    • N 109
    • BMI at GB 49.3 ± 9.0 kg/m 2
    • BMI at nadir 29.5 ± 5.9 kg/m 2
    • Excess BMI loss (EBL) 85% ± 23%
    • EBL ≥ 60% 92% of patients
    • Regained weight (RW) 22.1 ± 12.0 kg
    • Percent RW 37% ± 22%
    • Years after GB 7.2 ± 3.9
  • 16. Results Procedure
    • 22.7 ± 8.8 Plications
    • 50-75% Pouch reduction
      • 108 ± 14 ml to 36 ± 4 ml
    • 2 Intraoperative complications (2%):
      • 1 intraluminal bleeding
      • 1 esophageal injury during revisional EGPRSx
  • 17. Anastomosis Before and After EGPRSx Pre-EGPRSx Post-EGPRSx
  • 18. Results at 1 Year Means ± SD (n=109)
    • Weight 95.5 ± 18.1 kg
    • BMI 34.6 ± 6.2 kg/m2
    • Weight loss 8.0 ± 10.8 kg
    • %EWL 24% ± 36%
    • %EBL 12% ± 37%
    • %RWL 32% ± 57%
    60% achieved at least 15%EBL, 50% RWL, and BMI 35
  • 19. BMI Trajectory Means ± SEM (n=109)
  • 20. Three BMI Groups Means ± SD (n=109) Significant ( P = 0.01 ) increase of BMI < 35 and decrease of BMI >40
  • 21. Results - Predictors
    • Greater weight loss after EGPRSx was significantly ( P < 0.001) correlated with:
        • Greater percentage EBL after GB
        • Lower BMI before EGPRSx
        • Smaller gastric pouch after EGPRSx
    • Weight loss did not correlate with:
        • Age
        • Gender
        • Years after GB
  • 22. Conclusions
    • EGPRSx procedure can be performed safely with satisfactory weight loss at one year in 60% of patients
    • 50-75% pouch volume reduction from 108±14 ml to 36±4 ml through the formation of 22±8 plications
    • Modest weight loss at 12 ± 5 month follow-up:
      • 24 % ± 36% EWL
      • 32% ± 57% RWL
    • Greater weight loss post-EGPRSx correlated with greater weight loss after GB, lower weight pre-EGPRSx and smaller pouch post-EGPRSx
  • 23. Weight Loss Comparison Mullady et al (2009) - - 8.8 17 3 Horgan et al (2010) 32.0 18.0 - 96 6 Borao et al (2010) 29.0 18.0 7.9 18 6 ROSE Goodman 32.0 24.0 8.0 109 12 Leitman et al (2010) - - 7.3 64 6 Mikami et al (2010) - 19.5 10.0 6 12 Mikami et al (2010) - 17.0 8.7 14 6 EGPRSx Reference %RWL %EWL WL (kg) n FU (mo)
  • 24. Mechanism of Weight Loss After EGPRSx
    • Reduction of gastric pouch size
    • Reduction in stomal diameter
    • Reduction in gastric pouch compliance
    • Slowing of gastric emptying
  • 25. Lessons Learned
    • Procedure is safe
    • Reduces gastric pouch size and anastomotic diameter
    • Gross pouch dilation difficult to completely remediate
    • Weight loss modest but encouraging
    • Patients selection critical