New Horizons in Gastric Surgery

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


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


Pre anastomosis Post anastomosis


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)


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):

Stomal reduction with ROSE:Stomal reduction with ROSE:

Diameter 2.6cm Diameter 0.5cm

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

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

New Horizons in Gastric Surgery

Health & Medicine

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