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PPT presentation to be given at International Conference on the Stomach, Mumbai (India) Dec 5th 2010
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New Horizons in Bariatric Surgery – endoluminal treatments for weight
regain after gastric bypass:
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
Elliot R Goodman MD
Bariatric Surgery Service
Beth Israel Medical Center
New York, NY
BackgroundBackground
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
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.
BackgroundBackground 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
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.
Weight loss trajectory after gastric bypass:
Weight loss trajectory after gastric bypass:
BackgroundBackground 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
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
Background: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
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
Endoluminal Gastric Pouch Reduction (EGPR)
Endoluminal Gastric Pouch Reduction (EGPR)
StomaphyXTM
Endoluminal Gastric Pouch ReductionEndoluminal 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
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
Endoluminal Gastric Pouch ReductionEndoluminal 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
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
Diagram for fastenersDiagram for fasteners
H
H H
HH
H
Endoluminal Gastric Pouch ReductionEndoluminal Gastric Pouch Reduction
Endoluminal Gastric Pouch ReductionEndoluminal Gastric Pouch Reduction
Pre anastomosis Post anastomosis
Endoluminal Gastric Pouch ReductionEndoluminal Gastric Pouch Reduction
Gastro-esophageal Junction
Fluoroscopic evidence of stomal narrowing after EGPR with
Stomaphyx:
Fluoroscopic evidence of stomal narrowing after EGPR with
Stomaphyx:
GJ stoma before EGPR Stoma after EGPR
Serosa-to-serosa FusionSerosa-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)
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)
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%)
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)
RESULTS:RESULTS:
Dumping syndrome improved
GERD improved
Dumping syndrome improved
GERD improved
0
5
10
15
20
25
30
35
40
Pre-op Post-op
Dumping
GERD
Endoluminal Gastric Pouch ReductionEndoluminal 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
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
Latest data pooled from 3 large US centers
(BIMC, OSU and Alvarado Hospital):
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
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
Latest data (con):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
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
Predictive factors: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)
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)
The ROSE Procedure (by USGI):The ROSE Procedure (by USGI):
Incisionless Restorative Surgery Incisionless Restorative Surgery (ROSE)(ROSE)
Incisionless Restorative Surgery Incisionless Restorative Surgery (ROSE)(ROSE)
ROSE Registry | Site, Patient Mix
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
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
ROSE Registry | Design, DemographicsROSE Registry | Design, DemographicsROSE 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
ROSE Registry | Safety FindingsROSE Registry | Safety FindingsROSE 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
ROSE Registry | Acute Procedural ROSE Registry | Acute Procedural SuccessSuccess
ROSE Registry | Acute Procedural ROSE 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
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
Results-6 Month Weight Loss 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
Expandable Tissue AnchorsDurability
Expandable Tissue AnchorsDurability
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
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
Grouped Variable Analysis 6 month ROSE Data
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
Analysis/DiscussionAnalysis/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
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
Patient Initials: MR
Anchors in stoma: 2Anchors in pouch: 2
Weight: 230 lbsWeight lost since ROSE: 20 lbs
Estimated pouch length: 4.0 cmEstimated stoma diameter: 0.6 cm
Estimated pouch length: 6.0 cmEstimated stoma diameter: 0.8 cm
Patient Initials: KL
Anchors in stoma: 5Anchors in pouch: 3
Weight: 260 lbsWeight lost since ROSE: 21 lbs
ROSE: 90 day EGD
g-g Fistula Closureg-g Fistula Closure
Endoluminal Gastric Pouch ReductionEndoluminal Gastric Pouch Reduction
Mechanism of Weight loss
Reduction in size of pouch
Reduction in size of stoma
Reduce compliance of pouch
Slowed gastric emptying
Mechanism of Weight loss
Reduction in size of pouch
Reduction in size of stoma
Reduce compliance of pouch
Slowed gastric emptying
Conclusions: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
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