Endoscopic Devices for Weight Loss

Reem Sharaiha MD MSc Weill Cornell Medical College

Obesity •  Obesity is a metabolic

Disease –  Severe toll of co-morbid

illness •  Defined as BMI ≥ 30 •  Increase of

–  Convenience foods –  Labor-saving devices –  Motorized transport –  More sedentary

lifestyles

2000

Obesity Trends* Among U.S. Adults BRFSS, 1990, 2000, 2010

(*BMI ≥30, or about 30 lbs. overweight for 5’4” person)

2010

1990

No Data <10% 10%–14% 15%–19% 20%–24% 25%–29% ≥30%

Obesity Landscape

88.6M  

19  M  

97.8  M  

No  viable  solu3on  widely    available.  Diet/exercise    ineffec3ve  long  term,  surgery    not  an  op3on.    

Surgical  candidates  yet  only  2-­‐4%  (~200,000)  choose  this  op3on  each    year.      

Obesity Landscape •  1.3 B overweight or obese adults worldwide •  2.6 M people die each year as a result of

being overweight or obese •  Excess weight will soon rival tobacco as the

world’s leading cause of preventable premature deaths

•  The burden of obesity will soon become unaffordable to society

Jeffrey Algazy, et al. Payor and Provider Practice, “Why governments must lead the fight against obesity”, October 2010. McKinsey Quarterly Report, McKinsey & Company  

Bariatric Surgical Outcome

N Engl J Med 2007;357:741-52.  

Hazard  ra'o  Surgical  group  0.76          (P=0.04)  

25%  

16%  

14%  

Bariatric Surgical Outcomes % Weight loss

Schauer  PR  et  al.  N  Engl  J  Med  2014;370:2002-­‐2013.  

4.2%  

21.1%  

24.5%  

Spectrum of Care

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FDA Approval - 2015

11/26/15 9

THE  REDUCE  PIVOTAL  TRIAL:    A  PROSPECTIVE,  RANDOMIZED  CONTROLLED  PIVOTAL  TRIAL  OF  THE  RESHAPE  DUO  DUAL  INTRAGASTRIC  BALLOON  FOR  

THE  TREATMENT  OF  OBESITY

•  Saline-filled intragastric dual balloon device designed to reduce food intake.

•  Objectives: To evaluate the safety and effectiveness at 24 weeks

•  Adverse events –  6% Balloon deflation –  No migration –  Retrieval for intolerances 15% –  Gastric ulcers **

•  Conclusions –  The ReShape Duo was significantly

more effective than diet and exercise alone in causing weight loss with a low adverse event profile

Presented  by  Ponce  et  al  Obesity  2014  

N=326  BMI  30-­‐40  

N=187  DUO  

N=139  Sham  

N=167  EWL  25.1%  

N=126  EWL  11%  

P=0.004  

ORBERA™ Pivotal Study: Subject Disposition & Demographics

Enrolled 448 Run-In

44 (planned 46)

Screen Failures 131

Randomized 273

Treatment 137

Control 136 SF After

Randomization 12

Control 130

Treatment 125

Drop-Outs After Randomization

6

D/C Before Week 52

27 Completed

Study – w52 98

Completed Study – w52

93

D/C Before Week 52

37

•  90% female •  Mean age = 38.7 years •  81% Caucasian •  70% married

•  Mean excess weight = 78.8 lbs

•  Mean BMI = 35.2 Demographics  

Greater Weight Loss in ORBERA™ Group through 12 months

mITT – Mixed Model / LOCF

0  

2  

4  

6  

8  

10  

12  

0   3   6   9   12  

Month M

ean

%TB

WL

(95%

CI)

10.2%

3.3%

ORBERA™ Control

9.1%

3.4% 3.1%

7.6%

Mean Δ 6.9 P<0.0001

Mean Δ 4.5

ORBERA™ provided 3.1x weight loss vs. diet & exercise alone Mean EWL at 6 months: 38%

Endoscopic Sleeve Gastroplasty

11/26/15 Fogel GIE 2008 68 (1) 51-8)

Surgery  for  Obesity  and  Related  Diseases  Volume  8,  Issue  3  2012  296  -­‐  303  

Months   1   3   12  

%  EWL   21.1   39.6   58.1  

BMI   <35   35-­‐40   >40  

%  EWL   85   56   48.9  

Endoscopic Sleeve Gastroplasty (TRIM TRIAL)

•  18 patients (14 at 12 mths)

•  Mean BMI 38 •  Procedure time 2 hrs •  No adverse events

11/26/15 Surgery for Obesity and Related Diseases Volume 8, Issue 3 2012 296 - 303

14  

Weight  (kg)  

BMI   Waist  (cm)  

Mean  reduc3on  

11   4   12  

All  <0.05  

Gastric Remodeling: Plication

Espinos  JC,  et  al.  Obes  Surg.  2013  Sep;23(9):1375-­‐83  

-­‐0.7  

-­‐0.6  

-­‐0.5  

-­‐0.4  

-­‐0.3  

-­‐0.2  

-­‐0.1  

0  0   3   6  

%TBWL  

%  EWL  

Pivotal  Trial  –Ac3vely  enrolling    

Gastric Remodeling: Sutures

•  Full-thickness suturing

•  May be more durable •  Repeatable •  Encouraging early

results

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Initial experience with endoscopic sleeve gastroplasty:technical success and reproducibility in the bariatricpopulation

Authors Reem Z. Sharaiha, Prashant Kedia, Nikhil Kumta, Ersilia M. DeFilippis1, Monica Gaidhane, Alpana Shukla,Louis J. Aronne, Michel Kahaleh

Institution Division of Gastroenterology & Hepatology, Department of Medicine, Weill Cornell Medical College, New York, USA

submitted 13. July 2014accepted after revision2. September 2014

BibliographyDOI http://dx.doi.org/10.1055/s-0034-1390773Published online: 2014Endoscopy© Georg Thieme Verlag KGStuttgart · New YorkISSN 0013-726X

Corresponding authorMichel Kahaleh, MDDivision of Gastroenterology &HepatologyDepartment of MedicineWeill Cornell Medical College1305 York Avenue, 4th FloorNew York, NY 10021USAFax: +1-646-962-0110mkahaleh@gmail.com

Innovations and brief communications

Introduction!

New endoscopic bariatric techniques have beendeveloped as standalone procedures or as ad-juncts to surgery. Endoscopic procedures havethe advantage of being reversible, with lower ad-verse events, and greater feasibility in poor surgi-cal candidates [1–5].Transoral gastroplasty (TOGA) utilizes two stapledevices to create a restrictive gastric pouch orsleeve along the lesser curvature, but is limitedby frequent staple-line dehiscence [5–7]. Othersimilar techniques include transoral gastric vol-ume reduction (TGVR)with endoluminal suturingsystems, such as the EndoCinch (C. R. Bard Inc.,Murray Hill, New Jersey, USA) and RESTORe(Bard/Davol, Warwick, Rhode Island, USA) [2,3,8–10].Recently, full-thickness endoscopic suturing hasbeen shown to create a more durable sleeve withtransmural tissue apposition [8]. In this case se-ries, we describe our experience in 10 patientswho underwent TGVR using the Overstitch endo-scopic suturing device (Apollo Endosurgery, Aus-tin, Texas, USA).

Methods!

The Endoscopic Suturing for GastrointestinalTract Disorders database is a prospective multi-center registry established at Weill Cornell Medi-cal College (IRB approval 04/26/2013). The regis-try’s objective is to assess the long-term efficacy,safety, and clinical outcomes of the endoscopicplacement of sutures. The data is recorded andstored in a secure electronic data-capturing sys-tem (REDCap).

Description of techniqueThe Overstitch endoscopic suturing device wasused to perform endoscopic sleeve gastroplasty(ESG).A standard upper gastrointestinal endoscope(GIF-H180; Olympus) was used to measure thedistance from the incisors of the gastroesophage-al junction and the pylorus. After an esophagealovertube (Guardus; US Endoscopy, Mentor, Ohio,USA) had been inserted, two parallel anterior andposterior suture placement sites were mappedusing argon plasma coagulation starting from theincisura and extending proximally to the gastro-esophageal junction.

Sharaiha Reem Z et al. Endoscopic sleeve gastroplasty… Endoscopy

Background and aims: Novel endoscopic tech-niques have been developed as effective treat-ments for obesity. Recently, reduction of gastricvolume via endoscopic placement of full-thick-ness sutures, termed endoscopic sleeve gastro-plasty (ESG), has been described. Our aim was toevaluate the safety, technical feasibility, and clini-cal outcomes for ESG.Patient and methods: Between August 2013 andMay 2014, ESG was performed on 10 patientsusing an endoscopic suturing device. Their weightloss, waist circumference, and clinical outcomeswere assessed.Results: Mean patient age was 43.7 years andmean body mass index (BMI) was 45.2kg/m2.

There were no significant adverse events noted.After 1 month, 3 months, and 6 months, excessweight loss of 18%, 26%, and 30%, and meanweight loss of 11.5kg, 19.4kg, and 33.0kg, respec-tively, were observed. The differences observed inmeanBMI andwaist circumferencewere4.9kg/m2

(P=0.0004) and 21.7cm (P=0.003), respectively.Conclusions: ESG is effective in achieving weightloss with minimal adverse events. This approachmay provide a cost-effective outpatient procedureto add to the steadily growing armamentariumavailable for treatment of this significant epi-demic.

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Sharaiha  RZ,  et  al  Endoscopy  2014    

Gastroplasty Multicenter DDW 2015

Months   0   6   12  

Weight   101.6   86.9   81.8  

TBWL  %   0   -­‐17.80%   -­‐19.00%  

BMI   36.2   30.9   29.8  

•  126 patients •  age 40.4 ±0.9 yrs •  81.9% female •  82 at six months •  40 at 12 months

Updated Sleeve data WCMC •  70 patients underwent

ESG (mean age 41 years, 67% female).

•  LDL from a mean of 132 to 112mg/dl (p=0.01)

•  HgbA1c from a mean of 6.8% to 5.6% (p=0.03).

-­‐30%  

-­‐25%  

-­‐20%  

-­‐15%  

-­‐10%  

-­‐5%  

0%  

-­‐30  

-­‐25  

-­‐20  

-­‐15  

-­‐10  

-­‐5  

0  0   1   2   3   4   5   6  

Weight  loss  p

ercent  

Weight  Loss  (kg)  

Months  

Absolute  Weight  Loss   Weight  Loss  Percent  

Months   0   6    p  value    

Waist  CM   141.5   119.8   0.0002  

BMI   45.2   40.3   0.0001  

LDL  mg/dl   132   112    0.01  

HbA1c   6.8   5.6   0.03  

Aspiration Therapy

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Aspiration Therapy

11/26/15 Sullivan S et al. Gastorenterology 2013 Dec(6) 1245 21  

•  US  pilot  RCT  (N=18)  •  11  Aspira'on,  Diet  and  Lifestyle  (7)  •  EWL  Aspira'on  48%  •  EWL  Lifestyle  14.9%  (p<0.04)  

Pathway  Trial    Closed  to  enrollment  

Duodenal-Jejunal Barrier Sleeve •  Anchor

– Nitinol –  Large proximal opening – Barbs to secure – Retrieval drawstring

•  Sleeve –  Impermeable fluoropolymer –  2 feet in length – Radiopaque markers

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Duodenal Sleeve •  Randomized blinded

pilot study (N=18), 24 week f/u –  12 sleeve –  6 sham –  Endpoints

•  HbA1C •  DM medication use •  Weight loss

Duodenal Sleeve

•  42% of DM meds vs 17% sham

•  Device migration issues

12  weeks     24  weeks  

P>0.05  

Duodenal-Jejunal Barrier Sleeve

11/26/15 25  

11.9%  

2.7%  

Duodenal-Jejunal Barrier Sleeve

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Duodenal Mucosal Resurfacing ��������� ��������� ���

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•  Ablation of duodenal mucosa and repopulation with jejunal mucosa

•  Early human data encouraging

Characteris3c   Baseline  Value  Age  [years]   53.7  ±  8.2  

Female  [N  (%)]   8  (38)  

BMI   31.3  ±  3.5  

Dura'on  Diabetes  [years]  

5.7  ±  3  

HbA1c  [%]   9.3  ±  1.4  

Medica'ons  [N]   1.8  ±  0.7  

28  

DMR

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2 % R e d u c tio n in H b A 1 c a t 6 m o n th s

M o n th s

Hb

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7 .9%(N = 2 1 )

7 .3%(N = 1 5 )

7 .4%(N = 5 )

9 .5%(N = 2 3 )

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Ryou  M,  et  al.  Gastrointest  Endosc.  2011  Feb;73(2):353-­‐9  Gonzales  KD,  et  al.  J  Pediatr  Surg.  2012  Jun;47(6):1291-­‐5  

Endoscopic Gastrojejunostomy

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Expandable Hydrogel Beads

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Expandable Hydrogel Beads

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New Paradigms in Obesity •  Risk / benefit ratio •  Procedures viewed as tools to help

manage a chronic condition, not as the ‘cure’

•  Repeatability

The battle of obesity: conclusions •  Combination therapy

and sequential therapy may also prove effective

•  Multidisciplinary team

work is critical to best treat this disease