Abeezar I. Sarela Consultant/Hon. Sen. Lecturer in Upper GI & Bariatric Surgery St James’s University Hospital, Leeds, UK ...
Agenda <ul><li>Enumerate available procedures </li></ul><ul><li>Trace evolution & current status </li></ul><ul><li>Discuss...
Surgery for Obesity <ul><li>Global epidemic of obesity </li></ul><ul><li>Bariatric surgery is the only effective and susta...
Bariatric Operations: Comparison of Weight Loss Sjostrom L et al.  Effects of Bariatric Surgery on Mortality in Swedish Ob...
But…….. <ul><li>Aetiology of obesity is multi-factorial </li></ul><ul><li>Bariatric surgery is not a cure for obesity </li...
The Search is On…. <ul><li>Low procedural risk </li></ul><ul><li>Technology-capable </li></ul><ul><li>Wide applicability <...
Endoscopic Bariatric Procedures ROSE, POSE (USGI) Anchors TOGa (Satiety Inc.) Staplers EndoBarrier (GI Dynamics) ValenTx S...
Primary Endoscopic Procedures ValenTx Valen TX (Sleeve – GOJ to jejunum) SAGES 2010 Barosense Restrictive implant Ann Surg...
Revisional Endoscopic Procedures Olympus Endosamurai Storz Anubis Olympus Eagle Claw ASMBS 2009 USGI ROSE Covidien Flexibl...
TOGA
TOGA: Endoscopic View Sleeve Outlet  Staple Line
TOGA:  ex-vivo  Anatomy
TOGA TransOral Gastroplasty <ul><li>~ 500 patients in Europe & USA </li></ul><ul><li>Full data-set on 171 patients </li></...
The Search Continues…… <ul><li>Behaviour modification </li></ul><ul><li>Monitor activity and eating pattern </li></ul><ul>...
Implantable  Gastric Electrical Stimulators
Implantation of Gastric Electrodes
Features <ul><li>Behaviour modification </li></ul><ul><li>Stimulation parameters </li></ul><ul><ul><li>Fixed vs. Adjustabl...
How does it work? <ul><li>Short pulse-width and high frequency electrical stimulation </li></ul><ul><ul><li>Increases affe...
Transcend IGS ™ System Transneuronix - Medtronics <ul><li>800 patients world-wide </li></ul><ul><li>10 years follow-up </l...
Transcend IGS ™ - SHAPE Trial <ul><li>Randomised, placebo-controlled, double-blind trial </li></ul><ul><li>190 patients at...
MetaCure  (2003; CE Mark 2006) TANTALUS ™ - Diabetes Control Technology <ul><li>13 patients </li></ul><ul><li>3 months the...
EnteroMedics  (2002) VBLOC ™  Therapy
VBLOC ™ - EMPOWER Trial <ul><li>Multi-centre </li></ul><ul><li>1 year double-blind, 4 years open-label </li></ul><ul><li>2...
EnteroMedics - VBLOC ™ <ul><li>CE mark - 2009 </li></ul><ul><li>VBLOC Therapy - Maestro system </li></ul><ul><ul><li>pendi...
<ul><li>Gastric Stimulation </li></ul><ul><ul><li>Creates early sensation of satiety </li></ul></ul><ul><ul><li>Reduces de...
IntraPace: abiliti ™ GSA102 Analyzer P102 Programmer W102 Programmer Wand LGS102 Stimulator LGL102 Lead
Endoscopy 6 Months Post-Implant
Study Population  Unpublished data Number of Subjects 30 Gender 25 Females  / 5  Males Age  (years) Mean, range 40  (20  t...
Abiliti ™:  Weight Loss  Unpublished data
Conclusions <ul><li>Licensed in Europe and USA </li></ul><ul><li>Attractive features  </li></ul><ul><ul><li>Safety </li></...
Emerging Paradigms in  Obesity Therapy <ul><li>Super-Obesity: Conventional Bariatric Surgery e.g. laparoscopic gastric byp...
Abeezar I. Sarela Consultant/Hon. Sen. Lecturer in Upper GI & Bariatric Surgery St James’s University Hospital, Leeds, UK ...
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Incisionless procedures and stomach pacemaker for obesity

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  • 11/09/11 Take out patient numbers at the bottom
  • 11/09/11
  • Incisionless procedures and stomach pacemaker for obesity

    1. 1. Abeezar I. Sarela Consultant/Hon. Sen. Lecturer in Upper GI & Bariatric Surgery St James’s University Hospital, Leeds, UK Visiting Consultant in Bariatric Surgery PN Hinduja National Hospital, Mumbai, India Update and Overview of Endoscopic Bariatric Procedures and Gastric Neuromodulation for Obesity
    2. 2. Agenda <ul><li>Enumerate available procedures </li></ul><ul><li>Trace evolution & current status </li></ul><ul><li>Discuss technique & mechanism of action </li></ul><ul><li>Review weight-control parameters </li></ul>
    3. 3. Surgery for Obesity <ul><li>Global epidemic of obesity </li></ul><ul><li>Bariatric surgery is the only effective and sustained treatment for morbid obesity </li></ul><ul><li>Bariatric surgery resolves diabetes and other co-morbidity and saves lives </li></ul><ul><li>Laparoscopic surgery has significant advantages over open procedures </li></ul><ul><li>Surgical morbidity and mortality are very low in experienced units </li></ul>
    4. 4. 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.
    5. 5. But…….. <ul><li>Aetiology of obesity is multi-factorial </li></ul><ul><li>Bariatric surgery is not a cure for obesity </li></ul><ul><li>Substantial incidence of weight regain </li></ul><ul><li>Definite short, medium and long-term risks with all bariatric operations </li></ul>
    6. 6. The Search is On…. <ul><li>Low procedural risk </li></ul><ul><li>Technology-capable </li></ul><ul><li>Wide applicability </li></ul>
    7. 7. Endoscopic Bariatric Procedures ROSE, POSE (USGI) Anchors TOGa (Satiety Inc.) Staplers EndoBarrier (GI Dynamics) ValenTx Sleeves StomaphyX (Endogastric Solutions) T-Fasteners EndoCinch (Bard) Spiderman (J&J) Suturing Sclerotherapy Product Technique
    8. 8. Primary Endoscopic Procedures ValenTx Valen TX (Sleeve – GOJ to jejunum) SAGES 2010 Barosense Restrictive implant Ann Surg. 2010 GI Dynamics Endobarrier (Sleeve – pylorus to jejunum) USGI Primary Obesity Surgery Endoscopic (POSE) SAGES 2010 Endocinch, Bard Endoscopic Vertical Gastroplasty Surg Endosc, DDW, 2009 Satiety Inc. TransOral GAstroplasty (TOGA)
    9. 9. Revisional Endoscopic Procedures Olympus Endosamurai Storz Anubis Olympus Eagle Claw ASMBS 2009 USGI ROSE Covidien Flexible Endostitch IFSO 2009 J&J Spiderman Surg Endosc 2010 Endogastric Solutions StomaphyX RESTORe Trial, DDW 2010 Bard EndoCinch Sclerotherapy
    10. 10. TOGA
    11. 11. TOGA: Endoscopic View Sleeve Outlet Staple Line
    12. 12. TOGA: ex-vivo Anatomy
    13. 13. TOGA TransOral Gastroplasty <ul><li>~ 500 patients in Europe & USA </li></ul><ul><li>Full data-set on 171 patients </li></ul><ul><li>Follow-up </li></ul><ul><ul><li>6 months: 111 patients </li></ul></ul><ul><ul><li>12 months: 76 patients </li></ul></ul><ul><ul><li>24 months: 20 months </li></ul></ul><ul><li>Median 39% EWL at 12 months </li></ul><ul><li>Safety: Adverse events – 3% </li></ul>
    14. 14. The Search Continues…… <ul><li>Behaviour modification </li></ul><ul><li>Monitor activity and eating pattern </li></ul><ul><li>Adjustable parameters </li></ul>
    15. 15. Implantable Gastric Electrical Stimulators
    16. 16. Implantation of Gastric Electrodes
    17. 17. Features <ul><li>Behaviour modification </li></ul><ul><li>Stimulation parameters </li></ul><ul><ul><li>Fixed vs. Adjustable </li></ul></ul><ul><li>Duration of stimulation </li></ul><ul><ul><li>Constant vs. Episodic </li></ul></ul><ul><li>Intelligent sensing </li></ul>
    18. 18. How does it work? <ul><li>Short pulse-width and high frequency electrical stimulation </li></ul><ul><ul><li>Increases afferent vagal activity </li></ul></ul><ul><ul><li>Blocks efferent vagal activity </li></ul></ul><ul><ul><li>Gastric distention </li></ul></ul><ul><ul><li>Inhibits post-prandial antral contractions </li></ul></ul><ul><ul><li>Slows gastric emptying </li></ul></ul><ul><ul><li>Inhibition of post-prandial gastric slow waves </li></ul></ul>
    19. 19. Transcend IGS ™ System Transneuronix - Medtronics <ul><li>800 patients world-wide </li></ul><ul><li>10 years follow-up </li></ul><ul><li>35% excess weight loss </li></ul>
    20. 20. Transcend IGS ™ - SHAPE Trial <ul><li>Randomised, placebo-controlled, double-blind trial </li></ul><ul><li>190 patients at 8 centres </li></ul><ul><li>Primary end point: >10% EWL </li></ul><ul><ul><li>%EWL: Active vs. Sham </li></ul></ul><ul><ul><ul><li>11.8 ±17.6% vs. 11.7±16.9% </li></ul></ul></ul><ul><ul><li>EWL>20%: Active vs. Sham </li></ul></ul><ul><ul><ul><li>27% vs. 16% </li></ul></ul></ul>Shikora et al. SOARD 2009 WITHDRAWN
    21. 21. MetaCure (2003; CE Mark 2006) TANTALUS ™ - Diabetes Control Technology <ul><li>13 patients </li></ul><ul><li>3 months therapy </li></ul><ul><li>Weight 104 kg 100 kg </li></ul><ul><li>HbA1c 8.0 6.9 </li></ul><ul><li>Glucose 175 mg/dl 127 mg/dl </li></ul>Bohdjalian et al. Surg Endosc. 2009
    22. 22. EnteroMedics (2002) VBLOC ™ Therapy
    23. 23. VBLOC ™ - EMPOWER Trial <ul><li>Multi-centre </li></ul><ul><li>1 year double-blind, 4 years open-label </li></ul><ul><li>2:1 randomization </li></ul><ul><li>300 subjects, BMI 35-45 kg/m 2 </li></ul>
    24. 24. EnteroMedics - VBLOC ™ <ul><li>CE mark - 2009 </li></ul><ul><li>VBLOC Therapy - Maestro system </li></ul><ul><ul><li>pending FDA approval </li></ul></ul><ul><ul><li>USA commercialization in 2010 </li></ul></ul>?
    25. 25. <ul><li>Gastric Stimulation </li></ul><ul><ul><li>Creates early sensation of satiety </li></ul></ul><ul><ul><li>Reduces desire to eat between meals </li></ul></ul><ul><ul><li>Reduced meal volume </li></ul></ul><ul><li>Patient Support System </li></ul><ul><ul><li>Tracks & reports eating events </li></ul></ul><ul><ul><li>Tracks & reports exercise trends </li></ul></ul><ul><ul><li>Useful diagnostic for sleep disorders </li></ul></ul><ul><ul><li>Supports behavior modification </li></ul></ul><ul><li>Low Impact </li></ul><ul><ul><li>Excellent safety profile </li></ul></ul><ul><ul><li>Minimal lifestyle changes </li></ul></ul><ul><ul><ul><li>No special diets </li></ul></ul></ul><ul><ul><ul><li>No vitamin supplements </li></ul></ul></ul>IntraPace: Abiliti™ Consumption - Expenditure Wt Change =
    26. 26. IntraPace: abiliti ™ GSA102 Analyzer P102 Programmer W102 Programmer Wand LGS102 Stimulator LGL102 Lead
    27. 27. Endoscopy 6 Months Post-Implant
    28. 28. Study Population Unpublished data Number of Subjects 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) BMI Mean, range 43.8 (32.5 to 55)
    29. 29. Abiliti ™: Weight Loss Unpublished data
    30. 30. Conclusions <ul><li>Licensed in Europe and USA </li></ul><ul><li>Attractive features </li></ul><ul><ul><li>Safety </li></ul></ul><ul><ul><li>Diet & Behaviour modification </li></ul></ul><ul><ul><li>Intelligence </li></ul></ul><ul><ul><li>Adjustment </li></ul></ul><ul><li>Convincing potential for weight control </li></ul><ul><li>Diabetes resolution </li></ul>
    31. 31. Emerging Paradigms in Obesity Therapy <ul><li>Super-Obesity: Conventional Bariatric Surgery e.g. laparoscopic gastric bypass </li></ul><ul><li>Less Severe Obesity </li></ul><ul><ul><li>Classes 1 and 2 </li></ul></ul><ul><ul><li>Class 3 with BMI<45 kg/m 2 </li></ul></ul><ul><ul><ul><li>Gastric Electrical Stimulation </li></ul></ul></ul><ul><ul><ul><li>Endoscopic Bariatric Procedures </li></ul></ul></ul>
    32. 32. Abeezar I. Sarela Consultant/Hon. Sen. Lecturer in Upper GI & Bariatric Surgery St James’s University Hospital, Leeds, UK Visiting Consultant in Bariatric Surgery PN Hinduja National Hospital, Mumbai, India Update and Overview of Endoscopic Bariatric Procedures and Gastric Neuromodulation for Obesity

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