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