grand rounds- intragastric balloon
TRANSCRIPT
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Unlocking the Thin
gastric balloon the answerMatthew R. brackman, md, facs
Person Within: Is www.tummybubble.com
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338% of U.S. Adults are obese 95% of people fail diet and exercise alone In July 2015 the FDA approved the Intragastric Balloon for BMI 30-40 Why will it be any more successful than the Garren-Edwards Balloon of 1985?
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Garren-Edwards Balloon Smaller fill volumes Less durable material Uncontrolled providers Cylindrical shape (?ulcers)Withdrawn from market by 1990
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ReShape Balloon Orbera Balloon Dual Balloon (900 total cc) Single (400-700cc) Spherical Spherical Acid resistant silicone Selected providers Improved valve mechanism Multidisciplinary program
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Specializing in Obesity treatment
SurgicalMedical
Endoscopic
New York30 Central Park S
Manhattan
Massachusetts1515 Allen St
Springfield
MultidisciplinaryNutrition
PsychEducation
Support Groups
CERTIFIED
HealthcareFinancingPartners
Post Procedural Care
Maintenencecomplication management
Body Contouring
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balloon placement
balloon removal
pREOP SURGEON VISIT
pREOP NUTRITION VISIT eDUCATION
STEPS
surgeon visits
support groups
nutrition visits
support groups
surgeon follow up
nutrition visits
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RESULTSBalloons
Obesity Surgery 2008 meta-analysis 3608 pts 32.1% excess wt. lost
Early balloons showed no di�erence compared to pla-cebo.
Orbera Baloon
9.3-21.3% TBWL at 6mo10 prospective studies- 11-51% at 12mo %EWL2 studies at 36mo showed 6%TBWLOrbera vs sham 4 studies: -7% to 33 %EWL
ORBERA U.S. Pivotal Trial- multicenter, prospective, non blinded, control trial.255 ptsOrbera group- 40%EWL at 6mo72% achieved at least 25%EWLMean TBWL treatment/control at 6 mo= 10.54/4.71
ReShape Dual Balloon
REDUCE Pivotal Trial262 ptsrandomized, control, week 24 %EWL treatment/control = 25.1/11.348.8% achieved at least 25%EWL
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COMPLICATIONS
EARLY LATE Nausea, vomitting, spasm, heavy Ulceration (rare, usually super�cial) feeling, epigastric pain De�ation (3-23%) Intolerance (voluntary removal 4.2%) Intestinal Obstruction (rarer with dual Hemorrhage, perforation (mortality balloon (0 events in pivotal trial) 0.07%)
Dehydration
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CONTRAINDICATIONS Pregnancy or breast feeding Hiatal hernia > 5cm
In�ammatory bowel disease Uncontrolled psychologic disorder Prior stomach surgery Active ulceration or gastritis
Bleeding disorder, varices Esophageal disorders (achalasia, stricture)
Anticoagulation therapy Gastric mass
Alcohol or drug abuse Hepatic insu�ciency, cirrhosis
Noncompliant
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Implantation of Intragastric Balloons can result in signi�cant weight loss
Appears intragastric balloons have additional weight loss bene�t vs dietand exercise alone. An experienced, multi-disciplinary team is necessary to achieve these bene�ts.
Safety pro�le is very good with rare serious complications.
Early troublesome symptoms are common but short lived.
Can be used as a pre-operative adjunct for high risk bariatric surgery patients
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Dr. Brackman is the first physician certified to perform the Reshape Procedure in Massachusetts
and New York.
Contact [email protected] for more information
www.tummybubble.com