ASMBS, 2010

Predictors of weight loss following endoluminal gastric pouch reduction after failed

gastric bypass

Predictors of weight loss following endoluminal gastric pouch reduction after failed

gastric bypassElliot R. Goodman, M.D.*, David Bodansky, B.Med.Sc.,

Chiranjiv S. Virk, M.D., Burton Surick, M.D., John L. Holup, D.O., Daniel Rosen, M.D., I. Michael Leitman, M.D.,

Julie Ellner, M.D., Sol Silverman

*Department of SurgeryBeth Israel Medical Center

New York, NY

Elliot R. Goodman, M.D.*, David Bodansky, B.Med.Sc., Chiranjiv S. Virk, M.D., Burton Surick, M.D., John L. Holup,

D.O., Daniel Rosen, M.D., I. Michael Leitman, M.D.,

Julie Ellner, M.D., Sol Silverman

*Department of SurgeryBeth Israel Medical Center

New York, NY

ASMBS, 2010

DisclosuresDisclosuresStomaphyX is a product of EndoGastric

Solutions, Inc., Redmond, WA

Dr. Goodman is a consultant to EndoGastric Solutions

Other authors have no commercial associations that might be of conflict in relation to the presented study

StomaphyX is a product of EndoGastric Solutions, Inc., Redmond, WA

Dr. Goodman is a consultant to EndoGastric Solutions

Other authors have no commercial associations that might be of conflict in relation to the presented study

ASMBS, 2010

BackgroundBackground

150,000-200,000 bariatric operations done a year in the U.S.

67-75% EWL in 80% of patients in 2 years

95% of patients maintained at least 50% EWL at 12-year follow-up

150,000-200,000 bariatric operations done a year in the U.S.

67-75% EWL in 80% of patients in 2 years

95% of patients maintained at least 50% EWL at 12-year follow-up

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.

ASMBS, 2010

BackgroundBackgroundUsually a nadir weight is reached at 2 years

Estimated 10%-20% of patients regain significant weight at 5-10 years

12% of patients undergo surgical revision after gastric bypass surgery

Usually a nadir weight is reached at 2 years

Estimated 10%-20% of patients regain significant weight at 5-10 years

12% of patients undergo surgical revision after gastric bypass surgery

Gagner M., et al. Laparoscopic Reoperative Bariatric Surgery : Experience from 27 consecutive patients. Obes Surg, (12) 254-260, 2002.

ASMBS, 2010

BackgroundBackgroundReview of literature on re-operative bariatric

surgery17 publications (838 patients)

118 major complications (14%)11 deaths (1.3%)

64 patients - laparoscopic reoperation6 major complications (9%)Average OR time 4.5 hours

Review of literature on re-operative bariatric surgery17 publications (838 patients)

118 major complications (14%)11 deaths (1.3%)

64 patients - laparoscopic reoperation6 major complications (9%)Average OR time 4.5 hours

Jones KB. Revisional bariatric Surgery-potentially safe and effective. SOARDS 1 (2005) 599-603

ASMBS, 2010

BackgroundBackground

Weight regain after gastric bypassMultifactorial causes

Indication of revisional surgeryexhaustion of medical, psychological

and dietary efforts

Weight regain after gastric bypassMultifactorial causes

Indication of revisional surgeryexhaustion of medical, psychological

and dietary efforts

ASMBS, 2010

Complications of Revisional SurgeryComplications of

Revisional SurgeryAnastomotic leaksWound dehiscencesIncisional herniasPulmonary complicationsDeath

An effective endoscopic method may

avoids most of these complications

Anastomotic leaksWound dehiscencesIncisional herniasPulmonary complicationsDeath

An effective endoscopic method may

avoids most of these complications

ASMBS, 2010

Endoluminal Gastric Pouch Reduction Using StomaphyX

(EGPRSx)

Endoluminal Gastric Pouch Reduction Using StomaphyX

(EGPRSx)

StomaphyXTM

(EndoGastric Solutions):

• Approved in the U.S. and Europe for tissue approximation and full-thickness plication in the GI tract

• Patients who regained weight after gastric bypass and want another surgery for weight loss

• Patients with rapid gastric emptying or dumping syndrome associated with diarrhea

StomaphyXTM

(EndoGastric Solutions):

• Approved in the U.S. and Europe for tissue approximation and full-thickness plication in the GI tract

• Patients who regained weight after gastric bypass and want another surgery for weight loss

• Patients with rapid gastric emptying or dumping syndrome associated with diarrhea

ASMBS, 2010

EGPRSxEGPRSxEGPRSxEGPRSx

Click to play animation

ASMBS, 2010

ObjectiveObjectiveObjectiveObjective

To conduct a retrospective data review of 197 consecutive patients treated at two institutions to determine potential predictors of successful weight loss one year after EGPRSx

To conduct a retrospective data review of 197 consecutive patients treated at two institutions to determine potential predictors of successful weight loss one year after EGPRSx

ASMBS, 2010

Patients & MethodsPatients & Methods

Selection criteria: patients at least 2 years after original

gastric bypass and had regained at least 20% of weight lost at nadir

Preoperative work up: Upper endoscopy/ Upper GI swallow study.

Nutritional pre-op evaluation and post-op counseling on postoperative diet

Selection criteria: patients at least 2 years after original

gastric bypass and had regained at least 20% of weight lost at nadir

Preoperative work up: Upper endoscopy/ Upper GI swallow study.

Nutritional pre-op evaluation and post-op counseling on postoperative diet

ASMBS, 2010

EGPRSxEGPRSx

Anesthesia: general endotrachealUpper Endoscopy: to measure GE and GJGastroscope and StomaphyX passed down

esophagus as one unitStomaphyX uses suction to draw gastric

wall into deviceFirst 5 patients had simultaneous

laparoscopy to evaluate safety of plications

Anesthesia: general endotrachealUpper Endoscopy: to measure GE and GJGastroscope and StomaphyX passed down

esophagus as one unitStomaphyX uses suction to draw gastric

wall into deviceFirst 5 patients had simultaneous

laparoscopy to evaluate safety of plications

ASMBS, 2010

EGPRSx ProcedureEGPRSx Procedure7mm, 3-0 polypropylene fasteners

Typically 20-30 fasteners per case

Additional fasteners depending upon

pouch size

Start 1 cm proximal to stoma at 6 o’clock

1-2 cm proximal to first row 6 fasteners OR time 35-130 minutes

7mm, 3-0 polypropylene fasteners

Typically 20-30 fasteners per case

Additional fasteners depending upon

pouch size

Start 1 cm proximal to stoma at 6 o’clock

1-2 cm proximal to first row 6 fasteners OR time 35-130 minutes

ASMBS, 2010

Baseline Baseline CharacteristicsCharacteristics

Means ± SD

Baseline Baseline CharacteristicsCharacteristics

Means ± SD N treated 197 at two hospitals N followed up 109 (55%)

71 (36%) LFU; 17 (9%) no GB data

Gender 93% femaleAge 49.8 ± 10.4 yearsWeight 103.5 ± 18.5 kgBMI 37.5 ± 6.1 kg/m2

Excess weight 34.4 ± 16.5 kgRegained weight (RW) 22.1 ± 12.0 kg % RW 37 ± 22Years after GB 7.2 ± 3.9

N treated 197 at two hospitals N followed up 109 (55%)

71 (36%) LFU; 17 (9%) no GB data

Gender 93% femaleAge 49.8 ± 10.4 yearsWeight 103.5 ± 18.5 kgBMI 37.5 ± 6.1 kg/m2

Excess weight 34.4 ± 16.5 kgRegained weight (RW) 22.1 ± 12.0 kg % RW 37 ± 22Years after GB 7.2 ± 3.9

ASMBS, 2010

Characteristics Pre and Characteristics Pre and Post GBPost GB

Means ± SD

Characteristics Pre and Characteristics Pre and Post GBPost GB

Means ± SD

N 109BMI at GB 49.3 ± 9.0 kg/m2

BMI at nadir 29.5 ± 5.9 kg/m2

Excess BMI loss (EBL) 85% ± 23%EBL ≥ 60% 92% of patientsRegained weight (RW) 22.1 ± 12.0 kg Percent RW 37% ± 22%Years after GB 7.2 ± 3.9

N 109BMI at GB 49.3 ± 9.0 kg/m2

BMI at nadir 29.5 ± 5.9 kg/m2

Excess BMI loss (EBL) 85% ± 23%EBL ≥ 60% 92% of patientsRegained weight (RW) 22.1 ± 12.0 kg Percent RW 37% ± 22%Years after GB 7.2 ± 3.9

ASMBS, 2010

Results ProcedureResults ProcedureResults ProcedureResults Procedure

22.7 ± 8.8 Plications50-75% Pouch reduction

108 ± 14 ml to 36 ± 4 ml

2 Intraoperative complications (2%):1 intraluminal bleeding1 esophageal injury during revisional

EGPRSx

22.7 ± 8.8 Plications50-75% Pouch reduction

108 ± 14 ml to 36 ± 4 ml

2 Intraoperative complications (2%):1 intraluminal bleeding1 esophageal injury during revisional

EGPRSx

ASMBS, 2010

Anastomosis Before and After Anastomosis Before and After EGPRSxEGPRSx

Anastomosis Before and After Anastomosis Before and After EGPRSxEGPRSx

Pre-EGPRSx Post-EGPRSx

ASMBS, 2010

Results at 1 YearResults at 1 Year Means ± SD (n=109)

Results at 1 YearResults at 1 Year Means ± SD (n=109)

Weight 95.5 ± 18.1 kgBMI 34.6 ± 6.2 kg/m2Weight loss 8.0 ± 10.8 kg%EWL 24% ± 36%%EBL 12% ± 37%%RWL 32% ± 57%

Weight 95.5 ± 18.1 kgBMI 34.6 ± 6.2 kg/m2Weight loss 8.0 ± 10.8 kg%EWL 24% ± 36%%EBL 12% ± 37%%RWL 32% ± 57%

60% achieved at least 15%EBL, 50% RWL, and BMI 35

ASMBS, 2010

BMI TrajectoryBMI TrajectoryMeans ± SEM (n=109)

BMI TrajectoryBMI TrajectoryMeans ± SEM (n=109)

34.6

49.3

29.5

37.5

20

25

30

35

40

45

50

55

Pre-GB Nadir EGPRSx 12 Months

Me

an

BM

I (k

g/m2 )

ASMBS, 2010

Three BMI GroupsThree BMI Groups Means ± SD (n=109)

Three BMI GroupsThree BMI Groups Means ± SD (n=109)

Pre-EGPRSx

BMI > 40

28%45.3±4.4 BMI < 35

38%32.0±1.9

BMI 35-40

34%37.0±1.7

12-months Post-EGPRSx

BMI > 40

14%40.70±6.1

BMI < 35

55%29.8±2.9

BMI 35-40

31%34.7±3.9

Significant (P = 0.01) increase of BMI < 35 and decrease of BMI >40

ASMBS, 2010

Results - PredictorsResults - PredictorsResults - PredictorsResults - PredictorsGreater weight loss after EGPRSx was

significantly (P < 0.001) correlated with:Greater percentage EBL after GBLower BMI before EGPRSxSmaller gastric pouch after EGPRSx

Weight loss did not correlate with:AgeGenderYears after GB

Greater weight loss after EGPRSx was significantly (P < 0.001) correlated with:

Greater percentage EBL after GBLower BMI before EGPRSxSmaller gastric pouch after EGPRSx

Weight loss did not correlate with:AgeGenderYears after GB

ASMBS, 2010

ConclusionsConclusions ConclusionsConclusions EGPRSx procedure can be performed safely with

satisfactory weight loss at one year in 60% of patients

50-75% pouch volume reduction from 108±14 ml to 36±4 ml through the formation of 22±8 plications

Modest weight loss at 12 ± 5 month follow-up: 24 % ± 36% EWL 32% ± 57% RWL

Greater weight loss post-EGPRSx correlated with greater weight loss after GB, lower weight pre-EGPRSx and smaller pouch post-EGPRSx

EGPRSx procedure can be performed safely with satisfactory weight loss at one year in 60% of patients

50-75% pouch volume reduction from 108±14 ml to 36±4 ml through the formation of 22±8 plications

Modest weight loss at 12 ± 5 month follow-up: 24 % ± 36% EWL 32% ± 57% RWL

Greater weight loss post-EGPRSx correlated with greater weight loss after GB, lower weight pre-EGPRSx and smaller pouch post-EGPRSx

ASMBS, 2010

Weight Loss Weight Loss ComparisonComparisonWeight Loss Weight Loss ComparisonComparison

FU (mo)

n WL (kg)

%EWL

%RWL Reference

EGPRSx

6 14 8.7 17.0 - Mikami et al (2010)

12 6 10.0 19.5 - Mikami et al (2010)

6 64 7.3 - - Leitman et al (2010)

12 109 8.0 24.0 32.0 Goodman

ROSE6 18 7.9 18.0 29.0 Borao et al

(2010)

6 96 - 18.0 32.0 Horgan et al (2010)

3 17 8.8 - - Mullady et al (2009)

ASMBS, 2010

Mechanism of Weight Loss After EGPRSx

Mechanism of Weight Loss After EGPRSx

Reduction of gastric pouch size

Reduction in stomal diameter

Reduction in gastric pouch compliance

Slowing of gastric emptying

Reduction of gastric pouch size

Reduction in stomal diameter

Reduction in gastric pouch compliance

Slowing of gastric emptying

ASMBS, 2010

Lessons LearnedLessons LearnedLessons LearnedLessons LearnedProcedure is safeReduces gastric pouch size and

anastomotic diameterGross pouch dilation difficult to

completely remediateWeight loss modest but

encouragingPatients selection critical

Procedure is safeReduces gastric pouch size and

anastomotic diameterGross pouch dilation difficult to

completely remediateWeight loss modest but

encouragingPatients selection critical