Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric...

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Dark Side of The Balloon Mati Shnell

Transcript of Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric...

Page 1: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Dark Side of The Balloon

•Mati Shnell

Page 2: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Vignette

• 25 years old female

• Obesity, no chronic Rx

• Presented to the ER with abdominal pain and nausea

• Accidental foreign body ingestion

Page 3: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Endoscopy

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Page 4: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

What’s Next?

• What is the foreign body?

• Remove?

• Call a surgeon?

Page 5: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Body Packing - Leave and Let Live

• ESGE recommends close observation in asymptomatic individuals who have concealed packets of drugs by swallowing

• We recommend against endoscopic retrieval

• We recommend surgical referral in cases of suspected packet rupture, failure of packets to progress, or intestinal obstruction

Birk M, Endoscopy 2016

Page 6: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

The Nylon Thickens

• Upon inspection the bag ruptured

• Successful endoscopic removal

• The authorities were notified

Page 7: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Home Made Intragastric Balloon*

* Patent pending

Page 8: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Intragastric Balloons –Adverse Events

Case Records of The Bariatric Endoscopy Unit

Page 9: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Intragastric Balloons

• Introduction

• Cases - complications

• Discussion

Page 10: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Intragastric Balloons – The Basics

• Primary endoscopic bariatric treatment

• Renewed interest due to recent FDA approval for 3 models

• 6-12 months

• ~15% total body weight loss

Page 11: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Mechanisms of Action

• Restriction

• Delayed gastric emptying

• No effect on fasting or post-prandial ghrelin concentrations

Geliebter A, Am J Clin Nutr. 1988Gomez V, Obesity 2016Mathus-Vliegen EM, Obes Surg. 2014

Page 12: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Endoscopic IGB Models

• Shapes

• Water/fluid filled

• Duration

Orbera

ReshapeHeliosphereSpatz3

Page 13: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Case 1 – Outpatient Clinic

• 26 years old female

• No chronic medical treatment

• Spatz3 – 7 months (France)

• Lost 10 Kg

• Abdominal pain, nausea and vomiting

Page 14: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Case 1 - Imaging

• Positional contrast passage

Page 15: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Case 1 - Endoscopy

• Inflation tube serves as transpyloric anchor

• Successful endoscopic removal

Page 16: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Case 2 – ER Visit

• 41 years old female

• No chronic medical treatment

• Spatz3 – 7 months

• Lost 15 Kg

• Abdominal pain

Page 17: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Case 2 - Imaging

• Deep ulcer – anterior gastric wall

• Inflation tube embedded in the ulcer

Page 18: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Case 2 - Endoscopy

• Inflation tube causes deep gastric ulceration

• Successful endoscopic removal

Page 19: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Case 3 – Surgery Consultation

• 20 years old female

• No chronic medical treatment

• Spatz3 – 10 months

• Lost 6 Kg

• Severe abdominal pain

Dayan D, Obes Surg 2016

Page 20: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Case 3 - Imaging

• Free air

• No contrast extravasation

Dayan D, Obes Surg 2016

Page 21: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Case 3 - Laparoscopy

• Fibrin covered stomach

• Suspected microperforation

• Successful endoscopic removal

Dayan D, Obes Surg 2016

Page 22: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Case 4 - D.E.

• 54 years old female

• Major depression – Venlafaxine

• BMI 32

• Endball – 2 weeks

• General deterioration

Page 23: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Case 4 – Work Up

• No nausea\vomiting

• Normal Lab

• No response to diet modification

• No response to change in medication

• Depression exacerbation – refractory to Tx

Page 24: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Case – Concluded

• Successful endoscopic removal of balloon

• Referred to electroconvulsive therapy

Page 25: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Complications

Early removal

• Severe intolerance 0.44%

• Gastric perforation 0.19%, 40% mortality

• Gastric dilatation acute 0.08%, delayed 0.76%

• Spontaneous deflation 0.36%

Conservative

• Esophagitis – 1.27%

• Gastric ulcer – 0.2%

Genco A, Obes Surg 2005

Overall adverse events 3.3%

Page 26: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

IGB – US RCTs

• Early removal 10-18.8%

• Serious adverse events 10%• 75% hospitalization for intolerance

• 10% gastric ulcer

• 0.5-0.8% perforation

FDA. Summary of Safety and Effectiveness Data 2015

Page 27: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Complications - Rare

• Acute balloon spontaneous over-inflation

• Pancreatitis

FDA Alert, Feb 2017

Page 28: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Conclusions

• Effective EBT

• Patient selection

• Early vs late complications

• Avoid home made balloons

• Prepare yourself – OTC balloons are coming

Page 29: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Future Perspectives

• Obalon

• Elipse

Page 30: Dark Side of The Balloon · Intragastric Balloons –The Basics •Primary endoscopic bariatric treatment •Renewed interest due to recent FDA approval for 3 models •6-12 months

Thank You For Listening