Incisionless procedures and stomach pacemaker for obesity

Endoscopy & Neuromodulation

Abeezar I. SarelaConsultant/Hon. Sen. Lecturer in Upper GI & Bariatric Surgery

St James’s University Hospital, Leeds, UKVisiting Consultant in Bariatric Surgery

PN Hinduja National Hospital, Mumbai, India

Update and Overview of Endoscopic Bariatric Procedures

and Gastric Neuromodulationfor Obesity

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Agenda

• Enumerate available procedures

• Trace evolution & current status

• Discuss technique & mechanism of action

• Review weight-control parameters


Surgery for Obesity

• Global epidemic of obesity• Bariatric surgery is the only effective and

sustained treatment for morbid obesity• Bariatric surgery resolves diabetes and

other co-morbidity and saves lives• Laparoscopic surgery has significant

advantages over open procedures• Surgical morbidity and mortality are very

low in experienced units


Bariatric Operations:Comparison of Weight Loss

Sjostrom L et al. Effects of Bariatric Surgery on Mortality in Swedish Obese Subjects. N Engl J Med 2007;357:741-52.


But……..

• Aetiology of obesity is multi-factorial

• Bariatric surgery is not a cure for obesity

• Substantial incidence of weight regain

• Definite short, medium and long-term risks with all bariatric operations


The Search is On….

• Low procedural risk

• Technology-capable

• Wide applicability


Technique Product

Sclerotherapy

Suturing EndoCinch (Bard)

Spiderman (J&J)

Anchors ROSE, POSE (USGI)

T-Fasteners StomaphyX (Endogastric Solutions)

Staplers TOGa (Satiety Inc.)

Sleeves EndoBarrier (GI Dynamics)

ValenTx

Endoscopic Bariatric Procedures


Primary Endoscopic ProceduresTransOral GAstroplasty (TOGA)

Satiety Inc. Surg Endosc, DDW, 2009

Endoscopic Vertical Gastroplasty

Endocinch, Bard SAGES 2010

Primary Obesity Surgery Endoscopic (POSE)

USGI

Endobarrier (Sleeve – pylorus to jejunum)

GI Dynamics Ann Surg. 2010

Valen TX (Sleeve – GOJ to jejunum)

ValenTx

Restrictive implant Barosense SAGES 2010


Revisional Endoscopic ProceduresSclerotherapy

EndoCinch Bard RESTORe Trial, DDW 2010

StomaphyX Endogastric Solutions

Surg Endosc 2010

Spiderman J&J IFSO 2009

Flexible Endostitch Covidien

ROSE USGI ASMBS 2009

Eagle Claw Olympus

Endosamurai Olympus

Anubis Storz


TOGA


Sleeve Outlet Staple Line

TOGA: Endoscopic View


TOGA: ex-vivo Anatomy


TOGATransOral Gastroplasty

• ~ 500 patients in Europe & USA

• Full data-set on 171 patients

• Follow-up– 6 months: 111 patients

– 12 months: 76 patients

– 24 months: 20 months

• Median 39% EWL at 12 months

• Safety: Adverse events – 3%


The Search Continues……

• Behaviour modification

• Monitor activity and eating pattern

• Adjustable parameters


Implantable Gastric Electrical Stimulators


Implantation of Gastric Electrodes


Features

• Behaviour modification

• Stimulation parameters

– Fixed vs. Adjustable

• Duration of stimulation

– Constant vs. Episodic

• Intelligent sensing


How does it work?

Short pulse-width and high frequency electrical stimulation

– Increases afferent vagal activity– Blocks efferent vagal activity– Gastric distention– Inhibits post-prandial antral contractions– Slows gastric emptying – Inhibition of post-prandial gastric slow waves


Transcend IGS™ SystemTransneuronix - Medtronics

•800 patients world-wide•10 years follow-up•35% excess weight loss


Transcend IGS™ - SHAPE Trial

• Randomised, placebo-controlled, double-blind trial

• 190 patients at 8 centres

• Primary end point: >10% EWL

– %EWL: Active vs. Sham• 11.8±17.6% vs. 11.7±16.9%

– EWL>20%: Active vs. Sham• 27% vs. 16%

Shikora et al. SOARD 2009

WITHDRAWN


MetaCure (2003; CE Mark 2006)

TANTALUS™ - Diabetes Control Technology

• 13 patients

• 3 months therapy

• Weight 104 kg 100 kg

• HbA1c 8.0 6.9

• Glucose 175mg/dl 127mg/dl

Bohdjalian et al. Surg Endosc. 2009


EnteroMedics (2002)

VBLOC™ Therapy


VBLOC™ - EMPOWER Trial• Multi-centre• 1 year double-blind, 4 years open-label• 2:1 randomization• 300 subjects, BMI 35-45 kg/m2


EnteroMedics - VBLOC™

• CE mark - 2009

• VBLOC Therapy - Maestro system

– pending FDA approval

– USA commercialization in 2010

?


Consumption - Expenditure Wt Change=

Gastric Stimulation• Creates early sensation of satiety• Reduces desire to eat between meals• Reduced meal volume

Patient Support System• Tracks & reports eating events• Tracks & reports exercise trends• Useful diagnostic for sleep disorders • Supports behavior modification

Low Impact• Excellent safety profile • Minimal lifestyle changes

• No special diets• No vitamin supplements

IntraPace: Abiliti™


GSA102 Analyzer

P102 Programmer

W102 Programmer

Wand

LGS102 Stimulator

LGL102

Lead

IntraPace: abiliti™


Endoscopy 6 Months Post-Implant


Unpublished data

Study Population

Number ofSubjects

30

Gender 25 Females / 5 Males

Age (years)Mean, range

40 (20 to 60)

Weight (lb)Mean, range

284.6 (213.4 to 370)

Excess weight (lb)

124.6 (72.9 to 177.5)

BMIMean, range

43.8 (32.5 to 55)


Abiliti™: Weight Loss

Unpublished data


Conclusions• Licensed in Europe and USA

• Attractive features

– Safety

– Diet & Behaviour modification

– Intelligence

– Adjustment

• Convincing potential for weight control

• Diabetes resolution


Emerging Paradigms in Obesity Therapy

• Super-Obesity: Conventional Bariatric

Surgery e.g. laparoscopic gastric bypass

• Less Severe Obesity

– Classes 1 and 2

– Class 3 with BMI<45 kg/m2

• Gastric Electrical Stimulation

• Endoscopic Bariatric Procedures


Abeezar I. SarelaConsultant/Hon. Sen. Lecturer in Upper GI & Bariatric Surgery

St James’s University Hospital, Leeds, UKVisiting Consultant in Bariatric Surgery

PN Hinduja National Hospital, Mumbai, India

Update and Overview of Endoscopic Bariatric Procedures

and Gastric Neuromodulationfor Obesity

http://lthweb/sites/medical-illustration/the-trust-logo/log2full.jpg/image_view_fullscreen

Incisionless procedures and stomach pacemaker for obesity

Health & Medicine

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