PPT presentation to be given at International Conference on the Stomach, Mumbai (India) Dec 5th 2010

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. Background
 150,000-200,000 bariatric operations done a year
 Weight loss of 67-75% EBWL in 80% of patients in 2
years
 14 year follow up study: 95% of patients maintained
at least 50% EBWL
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. Background
 Estimated 10% - 20% will regain some weight at 5 and 10 years
 Usually a nadir weight is reached at 2 years
 Weight regain
 Mean 10-20% weight gain above nadir weight
 Many patients dropping below 50% of % EBWL after primary
surgery
 12% incidence of revision after gastric bypass surgery for
weight regain
Gagner M., et al. Laparoscopic Reoperative Bariatric Surgery : Experience from 27
consecutive patients. Obes Surg, (12) 254-260, 2002.

4. Weight loss
trajectory after
gastric bypass:

5. Background
 Review of Literature on Reoperative Bariatric Surgery
 838 patients - open reoperation
 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:
 2008 ASMBS Member Survey
• What is the weight loss expectation for an
endoluminal revisional procedure
• 76% felt 10-20% EWL at 12 months with safety
equivalent to that of a therapeutic endoscopy was
acceptable
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

7. Endoluminal Gastric Pouch Reduction
(EGPR)
StomaphyXTM

8. Endoluminal Gastric Pouch Reduction
StomaphyXTM
(EndoGastric Solutions, Redmond WA)
 FDA approved in the United States for endoluminal
tissue approximation
 CE marked in Europe
 Patients who want further weight loss
 Patients with rapid gastric emptying or dumping
syndrome associated with diarrhea

9. Endoluminal Gastric Pouch Reduction
 Procedure
 Average 20-40 3-0 polypropylene fasteners per case
 Start 1 cm proximal to stoma- 12-16 fasteners
 1-2 cm proximal to first row- another 12-16 fasteners
 Additional fasteners until 1cm below GE junction reached

10. Diagram for fasteners
H
H
H
HH
H

11. Endoluminal Gastric Pouch Reduction

12. Endoluminal Gastric Pouch Reduction
Pre anastomosis Post anastomosis

13. Endoluminal Gastric Pouch Reduction
Gastro-esophageal Junction

14. Fluoroscopic evidence of stomal
narrowing after EGPR with
Stomaphyx:
GJ stoma before EGPR Stoma after EGPR

15. Serosa-to-serosa Fusion
Full thickness
tissue plication and
serosa-to-serosa
fusion seen in
several animal
models

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. 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. 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. RESULTS:
 Dumping syndrome
improved
 GERD improved
0
5
10
15
20
25
30
35
40
Pre-op Post-op
Dumping
GERD

20. Endoluminal Gastric Pouch Reduction
 3 patients underwent repeat procedure
due to unsatisfactory results.
 Maximum weight loss: 67 lbs
 Postprandial diarrhea/GERD resolved.
 Slowed gastric emptying
 Obliteration of the gastrocolic
reflex
 New valve created just distal to GE
junction

21. Latest data pooled
from 3 large US centers
(BIMC, OSU and Alvarado Hospital):
 124 patients underwent EGPR at three
centers
 94% female mean age 49(+/-10)yrs
mean pre-EGPR BMI 39(+/-8)
 Mean 126lbs EWL after GB with 59lbs
regained 7.1 (+/-3.7) yrs after GB
 Followed for 6 months (+/-4 SD) after
EGPR

22. Latest data (con):
 EGPR reduced pouch length by 50(+/-
24)%
 Mean number of plications 22(+/-9)
 Mean weight loss 25lbs – 18% EWL or
43% RWL
 Weight loss range - 23lbs gain to
183lbs loss

23. Predictive factors:
 Weight loss after EGPR significantly
correlated with weight loss after initial
GB (p=0.001)
 Lower pre-EGPR BMI predicted better
weight loss after EGPR (p=0.009)

24. The ROSE Procedure (by USGI):

25. Incisionless Restorative SurgeryIncisionless Restorative Surgery
(ROSE)(ROSE)

26. ROSE Registry | Site, Patient
Mix
 9 sites collectively enrolled 116 patients
 Targeted cross section of users
 Bariatric surgeons
 Surgical endoscopists
 Gastroenterologists
 Targeted cross section of sites
 Academic centers
 Private community practices

27. ROSE Registry | Design, DemographicsROSE Registry | Design, 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
INCLUSION CRITERIA: Broadly defined to collect clinical experience across the full spectrum of revision patients
STUDY DESIGN:
• Screening EGD to evaluate for pouch and/or stoma dilatation
• Procedure performed under general anesthesia
• Routine gastroscopy done pre- and post-procedure to document pouch and stoma measurements
PATIENT DEMOGRAPHICS:
Gender 101 females (87%) / 15 males
(13%)
Mean Age 46 years
Mean BMI pre-
ROSE
40

28. ROSE Registry | Safety FindingsROSE Registry | Safety Findings
Intra-Op
No significant intra-op complications
Early in the experience:
 3 patients (<3%) with mucosal esophageal tear intra-operatively
 All resolved spontaneously within 24 hours
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

29. ROSE Registry | Acute ProceduralROSE Registry | Acute Procedural
SuccessSuccess
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
PRE-PROCEDURE
2.6 cm
POST-PROCEDURE
0.5 cm
INTRA-OP STOMA CHANGE

30. Patient Initials: 02
•Patient has lost 0 lbs after 3 months
•Stoma Diameter: 12mm x 20mm
•Pouch length: 7cm
•We counted about 15 T-Tags present
•Surgeon reported that he fired about 40 T-
Tags
Patient Initials: 01
•Patient has lost 0 lbs after 3 months
•Stoma Diameter: 25mm
•Pouch length: 6.5cm
•Only a couple of T-Tags were apparent
•Surgeon reported that he fired 15-20 T-
Tags
StomaphyX Case Study: 90 day EGD

31. Results-6 Month Weight Loss
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%
*based on target BMI 25kg/m2

32. Expandable Tissue Anchors
Durability
 Preclinical Research demonstrated tissue remodeling
mechanism
 Clinical Experience confirmed long term anchor
durability in multiple applications
 Anchors visible on 92% (61/66) of 12 month EGDs
post ROSE Procedure
12 month EGD
post-ROSE
12 month EGD post-
gastrotomy closure

33. 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

34. Analysis/Discussion
 Success post-bypass predicted ROSE
success at 6 months (p=.006)
• Top 20% RYGB pts (based on initial weight
loss) lost 29% EWL at 6 months with ROSE
 ROSE stopped weight regain in 88%
(84/96) of patients at 6 months

35. Patient Initials: MR
Anchors in stoma: 2
Anchors in pouch: 2
Weight: 230 lbs
Weight lost since ROSE: 20 lbs
Estimated pouch length: 4.0 cm
Estimated stoma diameter: 0.6 cm
Estimated pouch length: 6.0 cm
Estimated stoma diameter: 0.8 cm
Patient Initials: KL
Anchors in stoma: 5
Anchors in pouch: 3
Weight: 260 lbs
Weight lost since ROSE: 21 lbs
ROSE: 90 day EGD

36. g-g Fistula Closure

37. Endoluminal Gastric Pouch Reduction
Mechanism of Weight
loss
 Reduction in size
of pouch
 Reduction in size
of stoma
 Reduce
compliance of
pouch
 Slowed gastric
emptying

38. Conclusions:
 EGPR procedures are safe and can produce
almost 50% loss of regained weight after 6-12
months
 Long term durability still unknown
 Pouch size reduction and stomal narrowing
appears to treat dumping and GERD in most
patients
 Behavioral issues still play a major role in
determining success after EGPR