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
Endoscopy & Neuromodulation
Agenda
• Enumerate available procedures
• Trace evolution & current status
• Discuss technique & mechanism of action
• Review weight-control parameters
Endoscopy & Neuromodulation
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
Endoscopy & Neuromodulation
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.
Endoscopy & Neuromodulation
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
Endoscopy & Neuromodulation
The Search is On….
• Low procedural risk
• Technology-capable
• Wide applicability
Endoscopy & Neuromodulation
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
Endoscopy & Neuromodulation
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
Endoscopy & Neuromodulation
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
Endoscopy & Neuromodulation
TOGA
Endoscopy & Neuromodulation
Sleeve Outlet Staple Line
TOGA: Endoscopic View
Endoscopy & Neuromodulation
TOGA: ex-vivo Anatomy
Endoscopy & Neuromodulation
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%
Endoscopy & Neuromodulation
The Search Continues……
• Behaviour modification
• Monitor activity and eating pattern
• Adjustable parameters
Endoscopy & Neuromodulation
Implantable Gastric Electrical Stimulators
Endoscopy & Neuromodulation
Implantation of Gastric Electrodes
Endoscopy & Neuromodulation
Features
• Behaviour modification
• Stimulation parameters
– Fixed vs. Adjustable
• Duration of stimulation
– Constant vs. Episodic
• Intelligent sensing
Endoscopy & Neuromodulation
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
Endoscopy & Neuromodulation
Transcend IGS™ SystemTransneuronix - Medtronics
•800 patients world-wide•10 years follow-up•35% excess weight loss
Endoscopy & Neuromodulation
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
Endoscopy & Neuromodulation
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
Endoscopy & Neuromodulation
EnteroMedics (2002)
VBLOC™ Therapy
Endoscopy & Neuromodulation
VBLOC™ - EMPOWER Trial• Multi-centre• 1 year double-blind, 4 years open-label• 2:1 randomization• 300 subjects, BMI 35-45 kg/m2
Endoscopy & Neuromodulation
EnteroMedics - VBLOC™
• CE mark - 2009
• VBLOC Therapy - Maestro system
– pending FDA approval
– USA commercialization in 2010
?
Endoscopy & Neuromodulation
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™
Endoscopy & Neuromodulation
GSA102 Analyzer
P102 Programmer
W102 Programmer
Wand
LGS102 Stimulator
LGL102
Lead
IntraPace: abiliti™
Endoscopy & Neuromodulation
Endoscopy 6 Months Post-Implant
Endoscopy & Neuromodulation
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)
Endoscopy & Neuromodulation
Abiliti™: Weight Loss
Unpublished data
Endoscopy & Neuromodulation
Conclusions• Licensed in Europe and USA
• Attractive features
– Safety
– Diet & Behaviour modification
– Intelligence
– Adjustment
• Convincing potential for weight control
• Diabetes resolution
Endoscopy & Neuromodulation
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
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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