New Horizons in Bariatric Surgery – endoluminal treatments for weight regain after gastric bypass: Elliot R Goodman MD Bar...
Background <ul><li>150,000-200,000 bariatric operations done a year </li></ul><ul><li>Weight loss of 67-75% EBWL in 80% of...
Background <ul><li>Estimated 10% - 20%  will regain some weight at 5 and 10 years </li></ul><ul><li>Usually a nadir weight...
Weight loss  trajectory after gastric bypass:
Background <ul><li>Review of Literature on Reoperative Bariatric Surgery </li></ul><ul><ul><li>838 patients - open reopera...
Background: <ul><li>2008 ASMBS Member Survey </li></ul><ul><ul><li>What is the weight loss expectation for an endoluminal ...
Endoluminal Gastric Pouch Reduction (EGPR) StomaphyX TM
Endoluminal Gastric Pouch Reduction <ul><li>StomaphyX TM   (EndoGastric Solutions, Redmond WA) </li></ul><ul><ul><li>FDA a...
Endoluminal Gastric Pouch Reduction <ul><li>Procedure </li></ul><ul><ul><li>Average 20-40 3-0 polypropylene fasteners per ...
Diagram for fasteners H H H H H H
Endoluminal Gastric Pouch Reduction
Endoluminal Gastric Pouch Reduction Pre anastomosis Post anastomosis
Endoluminal Gastric Pouch Reduction Gastro-esophageal Junction
Fluoroscopic evidence of stomal narrowing after EGPR with Stomaphyx: GJ stoma before EGPR Stoma after EGPR
Serosa-to-serosa Fusion Full thickness tissue plication and serosa-to-serosa  fusion seen in several animal models
Beth Israel Medical Center results 2008-9 (N=64) 5 (2-10) Median time(years) after Gastric bypass surgery 31.3 Median BMI ...
7(12%) No follow up weight available 14(21%) No. Patients no weight loss 43(67%) No. Patients Weight loss 6(1-13) Median f...
23(10-40) Median # of fasteners 33%(0-67) Median reduction in gastric pouch length 50 (35-130) Median OR time 15.5(3.3-67)...
RESULTS: <ul><li>Dumping syndrome improved </li></ul><ul><li>GERD improved </li></ul>
Endoluminal Gastric Pouch Reduction <ul><li>3 patients underwent repeat procedure due to unsatisfactory results. </li></ul...
Latest data pooled  from 3 large US centers  (BIMC, OSU and Alvarado Hospital): <ul><li>124 patients underwent EGPR at thr...
Latest data (con): <ul><li>EGPR reduced pouch length by 50(+/-24)% </li></ul><ul><li>Mean number of plications 22(+/-9) </...
Predictive factors: <ul><li>Weight loss after EGPR significantly correlated with weight loss after initial GB (p=0.001) </...
Endoluminal Gastric Pouch Reduction <ul><li>Mechanism of Weight loss </li></ul><ul><li>Reduction in size of pouch </li></u...
The ROSE Procedure (by USGI):
Stomal reduction with ROSE: Diameter 2.6cm Diameter 0.5cm
Stoma/Pouch Reduction Achieved Cases Completed  N=112/116  (97%) Mean Final Stomal Diameter 11.5 mm Mean % Stomal Reductio...
Results-6 Month Weight Loss  *based on target BMI 25kg/m 2 6 Month Endpoint (N=96) Mean for  Total Registry Max for Indivi...
Conclusions: <ul><li>EGPR procedures are safe and can produce almost 50% loss of regained weight after 6-12 months </li></...
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New Horizons in Gastric Surgery

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  • New Horizons in Gastric Surgery

    1. 1. New Horizons in Bariatric Surgery – endoluminal treatments for weight regain after gastric bypass: Elliot R Goodman MD Bariatric Surgery Service Beth Israel Medical Center New York, NY
    2. 2. Background <ul><li>150,000-200,000 bariatric operations done a year </li></ul><ul><li>Weight loss of 67-75% EBWL in 80% of patients in 2 years </li></ul><ul><li>14 year follow up study: 95% of patients maintained at least 50% EBWL </li></ul>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.
    3. 3. Background <ul><li>Estimated 10% - 20% will regain some weight at 5 and 10 years </li></ul><ul><li>Usually a nadir weight is reached at 2 years </li></ul><ul><li>Weight regain </li></ul><ul><ul><li>Mean 10-20% weight gain above nadir weight </li></ul></ul><ul><ul><li>Many patients dropping below 50% of % EBWL after primary surgery </li></ul></ul><ul><li>12% incidence of revision after gastric bypass surgery for weight regain </li></ul>Gagner M., et al. Laparoscopic Reoperative Bariatric Surgery : Experience from 27 consecutive patients. Obes Surg, (12) 254-260, 2002.
    4. 4. Weight loss trajectory after gastric bypass:
    5. 5. Background <ul><li>Review of Literature on Reoperative Bariatric Surgery </li></ul><ul><ul><li>838 patients - open reoperation </li></ul></ul><ul><ul><ul><li>118 major complications (14%) </li></ul></ul></ul><ul><ul><ul><li>11 deaths (1.3%) </li></ul></ul></ul><ul><ul><li>64 patients - laparoscopic reoperation </li></ul></ul><ul><ul><ul><li>6 major complications (9%) </li></ul></ul></ul><ul><ul><ul><li>Average OR time 4.5 hours </li></ul></ul></ul>Jones KB. Revisional bariatric Surgery-potentially safe and effective. SOARDS 1 (2005) 599-603
    6. 6. Background: <ul><li>2008 ASMBS Member Survey </li></ul><ul><ul><li>What is the weight loss expectation for an endoluminal revisional procedure </li></ul></ul><ul><ul><li>76% felt 10-20% EWL at 12 months with safety equivalent to that of a therapeutic endoscopy was acceptable </li></ul></ul><ul><ul><li>Brethauer SA, Pryor AD, Chand B et al Endoluminal procedures for bariatric patients: expectations among bariatric surgeons (2009) Surg Obes Relat Dis Mar-Apr;5 (2): 231-6 </li></ul></ul>
    7. 7. Endoluminal Gastric Pouch Reduction (EGPR) StomaphyX TM
    8. 8. Endoluminal Gastric Pouch Reduction <ul><li>StomaphyX TM (EndoGastric Solutions, Redmond WA) </li></ul><ul><ul><li>FDA approved in the United States for endoluminal tissue approximation </li></ul></ul><ul><ul><li>CE marked in Europe </li></ul></ul><ul><ul><li>Patients who want further weight loss </li></ul></ul><ul><ul><li>Patients with rapid gastric emptying or dumping syndrome associated with diarrhea </li></ul></ul>
    9. 9. Endoluminal Gastric Pouch Reduction <ul><li>Procedure </li></ul><ul><ul><li>Average 20-40 3-0 polypropylene fasteners per case </li></ul></ul><ul><ul><li>Start 1 cm proximal to stoma- 12-16 fasteners </li></ul></ul><ul><ul><li>1-2 cm proximal to first row- another 12-16 fasteners </li></ul></ul><ul><ul><li>Additional fasteners until 1cm below GE junction reached </li></ul></ul>
    10. 10. Diagram for fasteners H H H H H H
    11. 11. Endoluminal Gastric Pouch Reduction
    12. 12. Endoluminal Gastric Pouch Reduction Pre anastomosis Post anastomosis
    13. 13. Endoluminal Gastric Pouch Reduction Gastro-esophageal Junction
    14. 14. Fluoroscopic evidence of stomal narrowing after EGPR with Stomaphyx: GJ stoma before EGPR Stoma after EGPR
    15. 15. Serosa-to-serosa Fusion Full thickness tissue plication and serosa-to-serosa fusion seen in several animal models
    16. 16. Beth Israel Medical Center results 2008-9 (N=64) 5 (2-10) Median time(years) after Gastric bypass surgery 31.3 Median BMI Post-GB(nadir) 31.3 Median BMI Post-Gastric Bypass (nadir) 48.7 Median BMI Pre-Gastric Bypass 65 Height (inches) 92% female / 8% male Female / Male 47.5 (24-66) Age (years)
    17. 17. 7(12%) No follow up weight available 14(21%) No. Patients no weight loss 43(67%) No. Patients Weight loss 6(1-13) Median follow up(months) 37.75(25.1-55.2) Median BMI post Stomaphyx 39.85 (25.9-54.9) Median BMI before StomaphyX
    18. 18. 23(10-40) Median # of fasteners 33%(0-67) Median reduction in gastric pouch length 50 (35-130) Median OR time 15.5(3.3-67) Median weight loss (lbs.) post StomaphyX
    19. 19. RESULTS: <ul><li>Dumping syndrome improved </li></ul><ul><li>GERD improved </li></ul>
    20. 20. Endoluminal Gastric Pouch Reduction <ul><li>3 patients underwent repeat procedure due to unsatisfactory results. </li></ul><ul><li>Maximum weight loss: 67 lbs </li></ul><ul><li>Postprandial diarrhea/GERD resolved. </li></ul><ul><ul><ul><li>Slowed gastric emptying </li></ul></ul></ul><ul><ul><ul><li>Obliteration of the gastrocolic reflex </li></ul></ul></ul><ul><ul><ul><li>New valve created just distal to GE junction </li></ul></ul></ul>
    21. 21. Latest data pooled from 3 large US centers (BIMC, OSU and Alvarado Hospital): <ul><li>124 patients underwent EGPR at three centers </li></ul><ul><li>94% female mean age 49(+/-10)yrs mean pre-EGPR BMI 39(+/-8) </li></ul><ul><li>Mean 126lbs EWL after GB with 59lbs regained 7.1 (+/-3.7) yrs after GB </li></ul><ul><li>Followed for 6 months (+/-4 SD) after EGPR </li></ul>
    22. 22. Latest data (con): <ul><li>EGPR reduced pouch length by 50(+/-24)% </li></ul><ul><li>Mean number of plications 22(+/-9) </li></ul><ul><li>Mean weight loss 25lbs – 18% EWL or 43% RWL </li></ul><ul><li>Weight loss range - 23lbs gain to 183lbs loss </li></ul>
    23. 23. Predictive factors: <ul><li>Weight loss after EGPR significantly correlated with weight loss after initial GB (p=0.001) </li></ul><ul><li>Lower pre-EGPR BMI predicted better weight loss after EGPR (p=0.009) </li></ul>
    24. 24. Endoluminal Gastric Pouch Reduction <ul><li>Mechanism of Weight loss </li></ul><ul><li>Reduction in size of pouch </li></ul><ul><li>Reduction in size of stoma </li></ul><ul><li>Reduce compliance of pouch </li></ul><ul><li>Slowed gastric emptying </li></ul>
    25. 25. The ROSE Procedure (by USGI):
    26. 26. Stomal reduction with ROSE: Diameter 2.6cm Diameter 0.5cm
    27. 27. Stoma/Pouch Reduction Achieved Cases Completed N=112/116 (97%) Mean Final Stomal Diameter 11.5 mm Mean % Stomal Reduction 50% Mean Final Pouch Length 3.3 cm Mean % Pouch Reduction per Case 44% Mean # Total Anchors per Case 5.9 Mean O.R. Time 87 min
    28. 28. Results-6 Month Weight Loss *based on target BMI 25kg/m 2 6 Month Endpoint (N=96) Mean for Total Registry Max for Individual Subject Weight Loss (kg) 6.5kg 30kg %EWL* 18% 84% % Regained Weight Lost (RWL) 32% 300%
    29. 29. Conclusions: <ul><li>EGPR procedures are safe and can produce almost 50% loss of regained weight after 6-12 months </li></ul><ul><li>Long term durability still unknown </li></ul><ul><li>Pouch size reduction and stomal narrowing appears to treat dumping and GERD in most patients </li></ul><ul><li>Behavioral issues still play a major role in determining success after EGPR </li></ul>
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