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 >25% of RYGB patients regain almost all of their lost weight Linear relationship between % weight regain and GJ stomal
diameter (Dayyeh, Lautz, Thompson, 2011)
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 >25% of RYGB patients regain almost all of their lost weight Linear relationship between % weight regain and GJ stomal
diameter (Dayyeh, Lautz, Thompson, 2011)
12% incidence of revision after gastric bypass surgery for weight regain
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)
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
The ROSE Procedure (by USGI):The ROSE Procedure (by USGI):
Repair Of Surgery Endolumenal-ROSE
Repair of Dilated Gastric Pouch and Stoma
Repair Of Surgery Endolumenal-ROSE
Repair of Dilated Gastric Pouch and Stoma
Post RYGBP Dilated Stoma Post ROSE Procedure
ROSE with the USGI IOPROSE 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
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
Stoma/Pouch Reduction Achieved
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
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
ROSE WEIGHT LOSS WITH STOMA REDUCTION SUBSET
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 Loss5 % 9%
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
Durability of Plications at 12 (and 24 Month) Endoscopy
Durability of Plications at 12 (and 24 Month) Endoscopy
24 month EGD post-ROSE
12 month EGDs post-ROSE
Anchors visible on 92% (61/66 patients) at 12 month EGDs post ROSE
The IOP System for RevisionThe IOP System for Revision• ROSE plications have been shown to be durable
• ROSE proves to be a safe procedure• No major complications have occurred to date
• % EWL after initial bypass surgery and reducing a dilated stoma to under 10mm is a valuable predictor of success with ROSE
• Results to date begin to meet endoluminal expectations of ASMBS Technology Committee survey for revision (10-20%EWL)
• Safety - Achieved• Durability - Achieved• % EWL @ 12 months – On Target
• ROSE plications have been shown to be durable
• ROSE proves to be a safe procedure• No major complications have occurred to date
• % EWL after initial bypass surgery and reducing a dilated stoma to under 10mm is a valuable predictor of success with ROSE
• Results to date begin to meet endoluminal expectations of ASMBS Technology Committee survey for revision (10-20%EWL)
• Safety - Achieved• Durability - Achieved• % EWL @ 12 months – On Target
Apollo Endosurgery Apollo Endosurgery Overstitch System:Overstitch System:Apollo Endosurgery Apollo Endosurgery Overstitch System:Overstitch System:
Overstitch:Overstitch: General application
endoluminal platform Fits over a therapeutic
upper endoscope Uses 2-0/3-0 prolene or
vicryl sutures 144 cases performed in
last 8 months – 71 pouch or stomal reductions
General application endoluminal platform
Fits over a therapeutic upper endoscope
Uses 2-0/3-0 prolene or vicryl sutures
144 cases performed in last 8 months – 71 pouch or stomal reductions
Apollo Endosurgery Overstitch pilot study for weight regain (Thompson et al, 2011):
Apollo Endosurgery Overstitch pilot study for weight regain (Thompson et al, 2011):
Aim: To demonstrate technical feasibility, safety and short term efficacy
Prospective interventional case series 22 consecutive RYGB patients with
weight regain and a dilated GJ stoma
Aim: To demonstrate technical feasibility, safety and short term efficacy
Prospective interventional case series 22 consecutive RYGB patients with
weight regain and a dilated GJ stoma
Patient Characteristics:Patient Characteristics:Patient Characteristics: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
Patient Characteristics:Patient Characteristics:
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
22 RYGB patients presented with weight regain
Technique:Technique:Technique:Technique:
Outlet reduction:Outlet reduction: Tissue ablation (APC)Tissue ablation (APC) Interrupted stitches at the stomal marginInterrupted stitches at the stomal margin
Pouch reduction:Pouch reduction: Interrupted stitches in the pouch to Interrupted stitches in the pouch to
reduce its volumereduce its volume
Outlet reduction:Outlet reduction: Tissue ablation (APC)Tissue ablation (APC) Interrupted stitches at the stomal marginInterrupted stitches at the stomal margin
Pouch reduction:Pouch reduction: Interrupted stitches in the pouch to Interrupted stitches in the pouch to
reduce its volumereduce its volume
Results:Results:
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]
Technical success: 100%Technical success: 100% Post-stomal diameter 5.6+/-1.9mmPost-stomal diameter 5.6+/-1.9mm
Results:Results:Results:Results:Average weight loss 22.5+/-13.4lbs
Average follow-up time 3 months
% weight regain loss 60.4%
% excess weight loss 21.5%
n=18 patientsn=18 patients
Stoma vs. Pouch:Stoma vs. Pouch:Stoma vs. Pouch: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%
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