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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) Age (years) 47.5  (24-66) Female / Male 92% female / 8% male Height (inch...
Median BMI before StomaphyX 39.85 (25.9-54.9) Median BMI post Stomaphyx 37.75(25.1-55.2) Median follow up(months) 6(1-13) ...
Median weight loss (lbs.) post StomaphyX  15.5(3.3-67) Median OR time 50 (35-130) Median reduction in gastric pouch length...
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):
R epair  O f  S urgery  E ndolumenal-ROSE Repair of Dilated Gastric Pouch and Stoma Post RYGBP Dilated Stoma Post ROSE Pro...
ROSE with the USGI IOP Dilated pouch and stoma Stoma restoration: Use EOS to create circumferential folds around stoma  Cr...
ROSE Registry | Site, Patient Mix <ul><li>9 sites collectively enrolled 116 patients  </li></ul><ul><ul><li>Targeted cross...
ROSE Registry | Design, Demographics INCLUSION CRITERIA:  Broadly defined to collect clinical experience across the full s...
ROSE Registry | Safety Findings Intra-Op No significant intra-op complications <ul><li>Early in the experience: </li></ul>...
ROSE Registry | Acute Procedural Success PRE-PROCEDURE 2.6 cm POST-PROCEDURE 0.5 cm INTRA-OP STOMA CHANGE Cases Completed ...
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...
ROSE WEIGHT LOSS WITH STOMA REDUCTION SUBSET 12 MONTHS N=73 (min, max) 12 MONTHS N=22 (30% of N) (final stoma <10mm) MEAN ...
Grouped Variable Analysis  6 month ROSE Data Best Positive Group Predictors for %EWL at 6 months * *using linear regressio...
Analysis/Discussion <ul><li>Success post-bypass predicted ROSE success at 6 months (p=.006) </li></ul><ul><ul><li>Top 20% ...
Durability of Plications at 12 (and 24 Month) Endoscopy 24 month EGD post-ROSE 12 month EGDs  post-ROSE <ul><li>Anchors vi...
The IOP System for Revision <ul><li>ROSE plications have been shown to be durable </li></ul><ul><li>ROSE proves to be a sa...
<ul><li>Apollo Endosurgery  Overstitch System: </li></ul>
Overstitch : <ul><li>General application endoluminal platform </li></ul><ul><li>Fits over a therapeutic upper endoscope </...
Apollo Endosurgery  Overstitch  pilot study for weight regain ( Thompson et al , 2011): <ul><li>Aim: To demonstrate techni...
Patient Characteristics: Average pre-bypass weight 342.2+/-75.4lbs Average nadir weight 206.23+/-57.6lbs Average weight at...
Patient Characteristics: <ul><li>22 RYGB patients presented with weight regain </li></ul>Age 48+/-9 yrs Gender 16/22 (73%)...
Technique: <ul><li>Outlet reduction: </li></ul><ul><li>Tissue ablation (APC) </li></ul><ul><li>Interrupted stitches at the...
Results: <ul><li>Technical success: 100% </li></ul><ul><li>Post-stomal diameter 5.6+/-1.9mm </li></ul>Outlet (n=11) Pouch ...
Results: n=18 patients Average weight loss 22.5+/-13.4lbs Average follow-up time 3 months % weight regain loss 60.4% % exc...
Stoma vs. Pouch: Outlet reduction  n=10 Outlet/pouch reduction n=8 Average weight loss 15.6lbs 30.9lbs Average follow-up t...
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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Presentation on endoluminal therapies: Homerton University Hospital, May 16 2011

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Wide ranging talk on Stomaphyx ROSE and Apollo Overstitch

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Presentation on endoluminal therapies: Homerton University Hospital, May 16 2011

  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><ul><li>>25% of RYGB patients regain almost all of their lost weight </li></ul></ul><ul><ul><li>Linear relationship between % weight regain and GJ stomal diameter (Dayyeh, Lautz, Thompson, 2011) </li></ul></ul><ul><li>12% incidence of revision after gastric bypass surgery for weight regain </li></ul>
  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) Age (years) 47.5 (24-66) Female / Male 92% female / 8% male Height (inches) 65 Median BMI Pre-Gastric Bypass 48.7 Median BMI Post-Gastric Bypass (nadir) 31.3 Median BMI Post-GB(nadir) 31.3 Median time(years) after Gastric bypass surgery 5 (2-10)
  17. 17. Median BMI before StomaphyX 39.85 (25.9-54.9) Median BMI post Stomaphyx 37.75(25.1-55.2) Median follow up(months) 6(1-13) No. Patients Weight loss 43(67%) No. Patients no weight loss 14(21%) No follow up weight available 7(12%)
  18. 18. Median weight loss (lbs.) post StomaphyX 15.5(3.3-67) Median OR time 50 (35-130) Median reduction in gastric pouch length 33%(0-67) Median # of fasteners 23(10-40)
  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. R epair O f S urgery E ndolumenal-ROSE Repair of Dilated Gastric Pouch and Stoma Post RYGBP Dilated Stoma Post ROSE Procedure
  27. 27. ROSE with the USGI IOP Dilated pouch and stoma Stoma restoration: Use EOS to create circumferential folds around stoma Create permanent folds in pouch to reduce volume
  28. 28. ROSE Registry | Site, Patient Mix <ul><li>9 sites collectively enrolled 116 patients </li></ul><ul><ul><li>Targeted cross section of users </li></ul></ul><ul><ul><ul><li>Bariatric surgeons </li></ul></ul></ul><ul><ul><ul><li>Surgical endoscopists </li></ul></ul></ul><ul><ul><ul><li>Gastroenterologists </li></ul></ul></ul><ul><ul><li>Targeted cross section of sites </li></ul></ul><ul><ul><ul><li>Academic centers </li></ul></ul></ul><ul><ul><ul><li>Private community practices </li></ul></ul></ul>
  29. 29. ROSE Registry | Design, Demographics INCLUSION CRITERIA: Broadly defined to collect clinical experience across the full spectrum of revision patients <ul><li>STUDY DESIGN: </li></ul><ul><li>Screening EGD to evaluate for pouch and/or stoma dilatation </li></ul><ul><li>Procedure performed under general anesthesia </li></ul><ul><li>Routine gastroscopy done pre- and post-procedure to document pouch and stoma measurements </li></ul>PATIENT DEMOGRAPHICS: AGE TIME WEIGHT ≥ 18 Years old and < 65 Years old ≥ 2 years post Roux-en-Y Bypass Achieved ≥ 50% of EWL after initial RYGB surgery 1 3 6 12 Clinical/Nutritional Follow-Up X X X X EGD Follow-Up X X Gender 101 females (87%) / 15 males (13%) Mean Age 46 years Mean BMI pre-ROSE 40
  30. 30. ROSE Registry | Safety Findings Intra-Op No significant intra-op complications <ul><li>Early in the experience: </li></ul><ul><li>3 patients (<3%) with mucosal esophageal tear intra-operatively </li></ul><ul><li>All resolved spontaneously within 24 hours </li></ul>Discharge Sore Throat (41%) Nausea/Vomiting (12%) 85% discharged the same day Long-Term 12 month EGDs (N=66) documented absence of stricture or ulcer
  31. 31. ROSE Registry | Acute Procedural Success PRE-PROCEDURE 2.6 cm POST-PROCEDURE 0.5 cm INTRA-OP STOMA CHANGE Cases Completed 97% (112/116) 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
  32. 32. 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
  33. 33. 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%
  34. 34. ROSE WEIGHT LOSS WITH STOMA REDUCTION SUBSET 12 MONTHS N=73 (min, max) 12 MONTHS N=22 (30% of N) (final stoma <10mm) MEAN WEIGHT LOSS (LBS) 12.9 LBS 22.4 LBS MEAN % EWL (BMI25) 14 % 24 % MEAN %TBW Loss 5 % 9%
  35. 35. Grouped Variable Analysis 6 month ROSE Data Best Positive Group Predictors for %EWL at 6 months * *using linear regression modeling ¥ p<.05 statistically significant Predictive Grouping P-value ¥ %EWL from original bypass 0.0015 # of total anchors placed 0.0267 Female >50 0.0399 Pre-ROSE procedure pouch length 0.3187
  36. 36. Analysis/Discussion <ul><li>Success post-bypass predicted ROSE success at 6 months (p=.006) </li></ul><ul><ul><li>Top 20% RYGB pts (based on initial weight loss) lost 29% EWL at 6 months with ROSE </li></ul></ul><ul><li>ROSE stopped weight regain in 88% (84/96) of patients at 6 months </li></ul>
  37. 37. Durability of Plications at 12 (and 24 Month) Endoscopy 24 month EGD post-ROSE 12 month EGDs post-ROSE <ul><li>Anchors visible on 92% (61/66 patients) at 12 month </li></ul><ul><li>EGDs post ROSE </li></ul>
  38. 38. The IOP System for Revision <ul><li>ROSE plications have been shown to be durable </li></ul><ul><li>ROSE proves to be a safe procedure </li></ul><ul><ul><li>No major complications have occurred to date </li></ul></ul><ul><li>% EWL after initial bypass surgery and reducing a dilated stoma to under 10mm is a valuable predictor of success with ROSE </li></ul><ul><li>Results to date begin to meet endoluminal expectations of ASMBS Technology Committee survey for revision (10-20%EWL) </li></ul><ul><ul><li>Safety - Achieved </li></ul></ul><ul><ul><li>Durability - Achieved </li></ul></ul><ul><ul><li>% EWL @ 12 months – On Target </li></ul></ul>
  39. 39. <ul><li>Apollo Endosurgery Overstitch System: </li></ul>
  40. 40. Overstitch : <ul><li>General application endoluminal platform </li></ul><ul><li>Fits over a therapeutic upper endoscope </li></ul><ul><li>Uses 2-0/3-0 prolene or vicryl sutures </li></ul><ul><li>144 cases performed in last 8 months – 71 pouch or stomal reductions </li></ul>
  41. 41. Apollo Endosurgery Overstitch pilot study for weight regain ( Thompson et al , 2011): <ul><li>Aim: To demonstrate technical feasibility, safety and short term efficacy </li></ul><ul><li>Prospective interventional case series </li></ul><ul><li>22 consecutive RYGB patients with weight regain and a dilated GJ stoma </li></ul>
  42. 42. Patient Characteristics: Average pre-bypass weight 342.2+/-75.4lbs Average nadir weight 206.23+/-57.6lbs Average weight at suturing 260.0+/-68.6lbs
  43. 43. Patient Characteristics: <ul><li>22 RYGB patients presented with weight regain </li></ul>Age 48+/-9 yrs Gender 16/22 (73%) female Time from RYGB 6+/-2 years Stoma diameter 25.5+/-4.3mm Pouch length 5.3+/-2.0cm
  44. 44. Technique: <ul><li>Outlet reduction: </li></ul><ul><li>Tissue ablation (APC) </li></ul><ul><li>Interrupted stitches at the stomal margin </li></ul><ul><li>Pouch reduction: </li></ul><ul><li>Interrupted stitches in the pouch to reduce its volume </li></ul>
  45. 45. Results: <ul><li>Technical success: 100% </li></ul><ul><li>Post-stomal diameter 5.6+/-1.9mm </li></ul>Outlet (n=11) Pouch (n=11) Mean procedure time 28.6+/-21.6 mins 14.8+/-9.1 mins Median sutures 3 [1-7] 2 [1-5]
  46. 46. Results: n=18 patients Average weight loss 22.5+/-13.4lbs Average follow-up time 3 months % weight regain loss 60.4% % excess weight loss 21.5%
  47. 47. Stoma vs. Pouch: Outlet reduction n=10 Outlet/pouch reduction n=8 Average weight loss 15.6lbs 30.9lbs Average follow-up time 94 days 86 days % weight regain loss 63.2% 66.1% % excess weight loss 16.7% 26.3%
  48. 48. 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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