simon dexter leeds teaching hospitals trust. yearband insertionsremovals 2006-0771511 2007-081,04445...
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Simon DexterLeeds Teaching Hospitals
Trust
Year Band Insertions Removals2006-07 715 112007-08 1,044 452008-09 1,382 462009-10 1,638 822010-11 1,555 1252011-12 1,316 124
Year No. of gastric bypasses2006-07 8582007-08 1,3122008-09 2,5332009-10 3,7452010-11 4,7222011-12 5,407
Health and Social Care Information Centre
Mechanism of action
Volume restriction Malabsorption Gut hormone changes Vagal activation Dumping Altered taste & food cravings Emotional wellbeing Physical ability Set point theory
Metabolic surgery
Sjostrom et al (2004) NEJM
Foregut•Ghrelin, duodenal exclusion
Hindgut•GLP-1, PYY release
Novel procedures
SURGICAL PLACEMENT
Gastric electrical stimulation
ENDOSCOPIC PLACEMENT
Endobarrier Intragastric balloon POSE
6 months maximum
Weight loss 2 – 4 stone
Anchor• Nitinol• Large proximal opening• Barbs in each direction• Retrieval drawstrings
Liner• Impermeable fluoropolymer• 60 cm length
Delivery System– Pre-loaded with implant– Sterile, single use
Retrieval System– Endoscopic grasper, hood
– Sterile, single use
4
Long-term T2DMimprovement
with weight loss
Delayed T2DM reboundpost- removal
Safety
Second generationdevice
Immediate T2DMimprovement
>500 Subjects13 Studies
Post-Marketing/RegistryExperience
Non-randomized, single arm Single Center
• University of Sao Paulo (Sao Paulo, Brazil) Planned duration - 52 weeks Enrollment
• 22 subjects• BMI=30-65• HbA1c=6-11.5%
1 week liquid diet followed by institution’s Bariatric standard of care diet
12 Month Diabetes StudyReduction in HbA1c (n=13 completers)
-1.9
Baseline HbA1c = 8.9%
-2.3
1 YearData
11/13 subjects
HbA1c < 7%
6/11 subjectsHbA1c < 7%
12 Month Diabetes StudyImprovement in Cardiovascular Risk Factors (n=13 completers)
Baseline 52 weeks p value
Weight (kg) 121.8 ± 7.6 101.6 ± 5.7 <.0001
BMI (kg/m2) 45.3 ± 2.4 37.8 ± 1.8 <.0001
Waist circumference (cm) 131.6 ± 5.1 119.9 ± 5.1 <.0001
Total cholesterol (mg/dl)HDLLDLTriglycerides
205.4 ± 10.944.1 ± 3.7121.8 ± 9.7
214.2 ± 27.2
177.3 ± 8.943.1 ± 4.4104.4 ± 7.3
151.8 ± 14.2
0.00030.65
0.0050.005
Glucose (mg/dl) 174.9 ± 13.7 137.8 ± 13.1 0.009
Insulin (uU/mg) 21.1 ± 4.9 11.0 ± 1.5 0.034
HOMA IR 8.6 ± 1.9 3.7 ± 0.6 0.023
HbA1c (%) 8.9± 0.5 6.6 ± 0.3 <.0001
Data presented as mean ± SE
Compelling Impact on Key Risk Factors1 YearData
12 Month Diabetes StudyReduction in HbA1c (n=13 completers)
1 YearData
1 YearData
8.9%
6.6%
1 YearData
Mean Implant duration for all 22 subjects
Non-randomized, single arm Single Center
• Catolica University (Santiago, Chile) Planned duration - 52 weeks Treated
• 43 subjects• BMI: 35.4-58.4
1 week liquid diet followed by institution’s Bariatric standard of care diet
1 YearData
Baseline BMI = 45.2
Baseline 52 weeks p value
Weight (kg) 112.4 ± 2.4 89.8 ± 3.2 <.0001
BMI (kg/m2) 45.3 ± 0.8 36.1 ± 1.1 <.0001
Blood pressure (mmHg)SystolicDiastolic
134.0 ± 2.7 85.7 ± 1.3
124.7 ± 2.3 71.8 ± 1.8
0.003<.0001
Total cholesterol (mg/dl)HDLLDLTriglycerides
195.1 ± 7.0 44.3 ± 1.7119.9 ± 5.7
155.4 ± 14.2
159.6 ± 7.4 43.5 ± 1.5 93.9 ± 6.1
111.5 ± 10.0
<.00010.55
<.00010.001
Data presented as mean ± SE
Compelling Impact on Key Risk Factors1 YearData
12 Month Obesity StudyImprovement in Cardiovascular Risk Factors (n=27 completers)
All devices removed endoscopically
Common Events• Nausea, vomiting, abdominal pain
Rare Adverse Events • GI hemorrhage, dehydration, constipation,
diarrhea, hypoglycemia, vitamin or mineral deficiencies, liner obstruction
Gastric neuromodulation • Abiliti, Transcend - IGS
Gastric contractility modulation• Diamond (Tantalus)
Vagal stimulation• Vbloc
Diamond (Tantalus)• Gastric contractility modulation
Induces satiety signalling via CNS
DM2 study• HbA1c at baseline
7.8% -1.0 @ 1 year -1.1 @ 18/12
• %EWL 24.6% @ 18/12
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
Unpublished data
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)
Unpublished data
Bariatric surgery increasing Better understanding of mechanisms of action
Metabolic role of surgery Development of novel procedures