BRIGHAM AND WOMEN’S HOSPITAL        HARVARD MEDICAL SCHOOL   Endoscopic Repair of DilatedGastrojejunal Anastomoses Using a...
Background:                                         Weight Regain   Definition of success after bariatric surgery      1....
Background:                    Prevalence of Weight Regain       Occurs after post-operative year 1       Most RYGB pati...
Background:                    Etiologies of Weight Regain      Nutritional habits      Psychosocial environment      G...
Background:                                              Dilated GJ* Abu Dayyeh BK, Lautz DB, Thompson CC. Clin Gastroente...
Background:                        Management of Dilated GJ           Surgical revision                Complication rate...
Endoscopic Suturing Device               Suture arm                   Tissue                   anchor Anchor exchange
Endoscopic Suturing Device    Sutures                           Cinch Absorbable and non-absorbable  To secure closure...
Endoscopic Suturing Device:                     Cinch System                          Tissue of interest                  ...
Pilot Study   Aim:       To demonstrate technical feasibility, safety and        short term efficacy   Study design:   ...
Methods   Procedure       Performed under general anesthesia       CO2 insufflation       2-0 polypropylene   Technic...
Patient Characteristics   22 RYGB patients presented with weight    regain      Age                   48+9 years      Gen...
Patient CharacteristicsComorbidities             Pre-gastric   Post-gastric   Time of                            bypass   ...
Patient CharacteristicsAverage pre-bypass weight                      342.42+75.36 lbsAverage nadir weight                ...
Technique   Outlet reduction:       Tissue ablation (APC)       Interrupted stitches at       4                        ...
Technique
Results                             Outlet (n=11)    Pouch (n=11)Mean procedure time          28.6+21.6 mins   14.8+9.1 mi...
Results      > 30 mm            6 mm                Cinch
Results   Technical success:                  100% (22/22)   Post stomal diameter:               5.6 + 1.9 mm   (78% red...
ResultsAverage weight loss                  22.5+13.4 lbsAverage follow-up time                 3 months% weight regain lo...
Results               400Weight (lbs)               300                                  60.39%               200         ...
Individual Weight Trends                     Weight (lbs)
Follow-up EndoscopyPatient 5:-3 lbs  Initial          20 mmprocedure                                   4 mm3 months
Follow-up EndoscopyPatient 14:-31 lbs  Initialprocedure3 months                                  Tissue anchor
Stoma vs. Pouch                         10 outlet   8 outlet +                                       pouchAverage weight l...
Limitations   Small number of patients   Short term outcomes   Single tertiary center   Nutritional and physical activ...
Conclusion   Reducing GJ anastomosis size using this novel    endoscopic suturing device is technically feasible    and a...
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Stomal reduction with Apollo Overstitch

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Chris Thompson's data presented at DDW (Chicago, May 2011)

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Stomal reduction with Apollo Overstitch

  1. 1. BRIGHAM AND WOMEN’S HOSPITAL HARVARD MEDICAL SCHOOL Endoscopic Repair of DilatedGastrojejunal Anastomoses Using aNovel Endoscopic Suturing Device Pichamol Jirapinyo, Barham K. Abu Dayyeh, James Slattery, Michele B. Ryan, Rabindra R. Watson, David B. Lautz, Christopher C. Thompson
  2. 2. Background: Weight Regain Definition of success after bariatric surgery 1. Loss of excess weight ≥ 50%* 2. For morbidly obese group (BMI < 50)  BMI < 35 kg/m2** For super obese group (BMI ≥ 50)  BMI < 40 kg/m2** Weight regain is common in this population * Reinhold RB. Surg Gynecol Obstet 1982; 155:385-394.** Biron S, et al. Obes Surg 2004; 14(2):160-4.
  3. 3. Background: Prevalence of Weight Regain  Occurs after post-operative year 1  Most RYGB patients regain >30% of lost weight  Over 25% of RYGB patients regained almost all of their lost weights Control Gastric Bypass 30% Year 1* Sjostrom L, et al. NEJM 2004; 351: 2683-93.
  4. 4. Background: Etiologies of Weight Regain  Nutritional habits  Psychosocial environment  Genetics  Fistula  Increased gastric pouch volume  Dilated gastrojejunal anastomosis (GJ)** Abu Dayyeh BK, Lautz DB, Thompson CC. Clin Gastroenterol Hepatol 2011; 9(3):228-33.
  5. 5. Background: Dilated GJ* Abu Dayyeh BK, Lautz DB, Thompson CC. Clin Gastroenterol Hepatol 2011; 9(3):228-33.
  6. 6. Background: Management of Dilated GJ  Surgical revision  Complication rate up to 50%*  Mortality rate up to 2%*  Endoscopic techniques  Less invasive  Multiple options  Sclerotherapy  Tissue plication  Endoscopic suturing* Schwartz R, et al. Surgery 1988;104:806–12.
  7. 7. Endoscopic Suturing Device Suture arm Tissue anchor Anchor exchange
  8. 8. Endoscopic Suturing Device  Sutures  Cinch Absorbable and non-absorbable  To secure closure without  2-0 & 3-0 Polyglycolic Acid (PGA) the need to tie surgical knots  2-0 & 3-0 Polypropylene (PP)
  9. 9. Endoscopic Suturing Device: Cinch System Tissue of interest Cylinder PostEndoscope Suture Tissue anchor
  10. 10. Pilot Study Aim:  To demonstrate technical feasibility, safety and short term efficacy Study design:  Prospective interventional case series  22 consecutive RYGB patients with weight regain and a dilated stoma
  11. 11. Methods Procedure  Performed under general anesthesia  CO2 insufflation  2-0 polypropylene Technical success  Successful suture placement with reduction in stoma size to < 1 cm Follow-up  Follow-up visits at 3, 6, 12 months  Follow-up endoscopy at 6, 12 months
  12. 12. Patient Characteristics 22 RYGB patients presented with weight regain Age 48+9 years Gender 16/22 (72.7%) female Time from RYGB 6+2 years Stoma diameter 25.5+4.3 mm Pouch length 5.3+2.0 cm
  13. 13. Patient CharacteristicsComorbidities Pre-gastric Post-gastric Time of bypass bypass suturingDiabetes 54.5% 22.7% 27.3%Hypertension 54.5% 27.3% 36.4%GERD 31.8% 13.6% 13.6%Hyperlipidemia 27.3% 18.2% 27.3%Obstructive sleep apnea 13.6% 0% 4.5%
  14. 14. Patient CharacteristicsAverage pre-bypass weight 342.42+75.36 lbsAverage nadir weight 206.23+57.58 lbsAverage weight at suturing 260+68.62 lbs 400 350 Weight (lbs) 300 250 38.75% 200 150 100 Pre-bypass Nadir weight Weight at weight suturing
  15. 15. Technique Outlet reduction:  Tissue ablation (APC)  Interrupted stitches at 4 2 the anastomosis margin  Goal reduction to < 1cm Pouch reduction: 1  Interrupted stitches in the 3 pouch to reduce its volume
  16. 16. Technique
  17. 17. Results Outlet (n=11) Pouch (n=11)Mean procedure time 28.6+21.6 mins 14.8+9.1 minsMedian stitches [range] 3 [1-7] 2 [1-5]
  18. 18. Results > 30 mm 6 mm Cinch
  19. 19. Results Technical success: 100% (22/22) Post stomal diameter: 5.6 + 1.9 mm (78% reduction) Intra-procedural complications 9.1% (2/22) • Small esophageal abrasion from an overtube 1 • Arterial bleeding after stitch placement 1 Post-procedure complications 27.3% (6/22) • Retching, nausea/vomiting 4 • Stenosis requiring balloon dilation 1 • GI bleeding requiring blood transfusion 1
  20. 20. ResultsAverage weight loss 22.5+13.4 lbsAverage follow-up time 3 months% weight regain loss 60.39%% excess weight loss 21.54% N = 18/20 (90%) 20 out of 22 patients due for a 3 month follow-up
  21. 21. Results 400Weight (lbs) 300 60.39% 200 100 pre- nadir weight at weight at bypass weight suturing 3 months weight Average
  22. 22. Individual Weight Trends Weight (lbs)
  23. 23. Follow-up EndoscopyPatient 5:-3 lbs Initial 20 mmprocedure 4 mm3 months
  24. 24. Follow-up EndoscopyPatient 14:-31 lbs Initialprocedure3 months Tissue anchor
  25. 25. Stoma vs. Pouch 10 outlet 8 outlet + pouchAverage weight loss 15.6 lbs 30.9 lbsAverage follow-up time 94.1 days 86 days% weight regain loss 63.2% 66.1%% excess weight loss 16.7% 26.3% N = 18
  26. 26. Limitations Small number of patients Short term outcomes Single tertiary center Nutritional and physical activity history not included
  27. 27. Conclusion Reducing GJ anastomosis size using this novel endoscopic suturing device is technically feasible and appears safe This technology could provide an option for treating weight regain in RYGB patients This technology may also have other applications:  Ulcer oversewing  Fistula closure

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