Intragsatric balloon back to the future

1. IntragastricIntragastric BalloonsBalloons
Back To The FutureBack To The Future
Hossam Ghoneim, MDHossam Ghoneim, MD
Consultant GastroenterologistConsultant Gastroenterologist
Cairo UniversityCairo University

2. ““Obesity is now classified as aObesity is now classified as a
chronic disease.chronic disease.””
Source:Press Release WHO/46, 12 June 1997Source:Press Release WHO/46, 12 June 1997
World Health Organization (WHO)World Health Organization (WHO)

3. ►►Normal Range:Normal Range: BMI : 20 < 25BMI : 20 < 25
►►Overweight:Overweight: BMI : > 25 < 30BMI : > 25 < 30
►►Obese:Obese: BMI : > 30BMI : > 30
►►Morbid Obese:Morbid Obese: BMI : > 40BMI : > 40
►►Super Obese:Super Obese: BMI : > 50BMI : > 50
Definition of obesityDefinition of obesity

4. Prevalence of obesityPrevalence of obesity
►►200 million people in the world are obese:200 million people in the world are obese:
1995. 300 millions today. In 2010, 50 % in1995. 300 millions today. In 2010, 50 % in
west country ( WHO)west country ( WHO)
►►One person in three are overweight or obeseOne person in three are overweight or obese
in USA.in USA.
►►Europe : from 1980 progression from 10 toEurope : from 1980 progression from 10 to
40 % ( England , Germany)40 % ( England , Germany)

5. Consequences of ObesityConsequences of Obesity
►► Premature mortality, morbidity and social disadvantagePremature mortality, morbidity and social disadvantage
►► Diabetes: risk factor ( RF ) x 2,5Diabetes: risk factor ( RF ) x 2,5
►► Hypertension: RF x 2Hypertension: RF x 2
►► Cardiovascular Function: RF x 2Cardiovascular Function: RF x 2
►► Cancer: RF x 2Cancer: RF x 2
►► Gallbladder Disease: RF x 2Gallbladder Disease: RF x 2
►► Arthritis: RF x 2,3Arthritis: RF x 2,3
►► Psychosocial DysfunctionPsychosocial Dysfunction

6. Mortality RiskMortality Risk

7. Treatment OptionsTreatment Options
►► Surgical treatmentSurgical treatment
►► NonNon--surgical treatmentsurgical treatment

8. BMIBMI
Treatment optionsTreatment options

9. Surgical Treatment for MorbidSurgical Treatment for Morbid
ObesityObesity
►► Reduction of AbsorptionReduction of Absorption
§§ Gastric BypassGastric Bypass
§§ Biliopancreatic diversionBiliopancreatic diversion
►► Reduction of IntakeReduction of Intake
§§ Gastric BandingGastric Banding
►► LAPLAP--BANDBAND®®--SystemSystem
§§ VBGVBG

10. Non Surgical treatmentNon Surgical treatment
►►Weight Loss ProgramsWeight Loss Programs
►►Pharmaceutical AgentsPharmaceutical Agents
►►Gene therapyGene therapy
►►Intragastric BalloonIntragastric Balloon

11. IntragastricIntragastric BalloonsBalloons
The BIB SystemThe BIB System

12. History ofHistory of IntragastricIntragastric balloonballoon’’s in generals in general

13. GarrenGarren--Edwards BubbleEdwards Bubble
►► 19841984 GarrenGarren gastric bubblegastric bubble
publicationspublications
-- PolyurethanePolyurethane
-- Air FilledAir Filled
-- 220 ml220 ml
-- Sharp edgesSharp edges
-- Recommended placement: 3Recommended placement: 3
monthsmonths

14. GarrenGarren--Edwards BubbleEdwards Bubble (cont(cont’’d)d)
►► ProblemsProblems
§§ High complication rates associated with sharpHigh complication rates associated with sharp
edges and can shape.edges and can shape.
§§ Low effectiveness and frequent deflationLow effectiveness and frequent deflation
attributed to low fill volume and air filled.attributed to low fill volume and air filled.

15. Tarpon SpringsTarpon Springs
►►1987 Obesity Congress1987 Obesity Congress ““Tarpon SpringsTarpon Springs”” (USA)(USA)
§§ Scientific conference held with 75 internationalScientific conference held with 75 international
experts from the fields of gastroenterology,experts from the fields of gastroenterology,
surgery, obesity, nutrition andsurgery, obesity, nutrition and DBM expertsDBM experts toto
develop a general consensus on thisdevelop a general consensus on this
technology/treatment option.technology/treatment option.

16. Tarpon Springs CriteriaTarpon Springs Criteria
►► Effective at promoting weight lossEffective at promoting weight loss
►► Filled with liquid ( not air )Filled with liquid ( not air )
►► Capable of adjustment to various sizesCapable of adjustment to various sizes
►► Have smooth surface and low potential for causing ulcerHave smooth surface and low potential for causing ulcer
and obstructionsand obstructions
►► Contain aContain a radiopaqueradiopaque marker that allows proper followmarker that allows proper follow--
up of the device if it deflatesup of the device if it deflates
►► Be constructed of durable materials that DOES NOT LEAKBe constructed of durable materials that DOES NOT LEAK

17. The BIB SystemThe BIB System

18. The BIB SystemThe BIB System
►► Distinctive Physical CharacteristicsDistinctive Physical Characteristics
-- Perfectly roundPerfectly round
-- SiliconeSilicone ElastomerElastomer
-- Smooth surfaceSmooth surface
-- RadiopaqueRadiopaque markermarker
-- 6 month life6 month life
-- Saline filled, 400Saline filled, 400 -- 700 ml700 ml

19. How does the BIB work?How does the BIB work?
►►Nausea during starting period.Nausea during starting period.
►►Food stays in stomach longer ( gastric emptying)Food stays in stomach longer ( gastric emptying)
►►Promotes satiety.Promotes satiety.

20. Who will benefit from BIB ?Who will benefit from BIB ?
►►Patient who can not abide by a strict diet programPatient who can not abide by a strict diet program
►►BMI not yet indicated for surgeryBMI not yet indicated for surgery
►►Indicated for surgery but prefers a less invasiveIndicated for surgery but prefers a less invasive
approachapproach
►►Well motivated patient with clear and realisticWell motivated patient with clear and realistic
expectationsexpectations

21. Indications of BIBIndications of BIB
►► Body weight > 40% ofBody weight > 40% of
ideal weightideal weight
►► BMI > 30 and < 40BMI > 30 and < 40
►► PreoperativePreoperative
§§ BariatricBariatric surgery (BMI>45)surgery (BMI>45)
§§ Other major surgeryOther major surgery

22. Criteria for successCriteria for success
►►Major criteria of success is a well informed patientMajor criteria of success is a well informed patient
§§ ComplianceCompliance
§§ Clear expectationClear expectation
►►Understanding of the possible nausea and vomiting withinUnderstanding of the possible nausea and vomiting within
the first daysthe first days
§§ MotivationMotivation
§§ Good follow up with team specialistsGood follow up with team specialists

23. Results of this criteriaResults of this criteria
►► BIBBIB™™ SystemSystem .. Over 10.000 applied.. Over 10.000 applied
0
1000
2000
3000
4000
5000
6000
98 99 00 01
Year
Units
Sales BIB Units

24. PrePre--placement careplacement care
►►NPO 6NPO 6--8 hours before placement8 hours before placement
►►Always accompanying person presentAlways accompanying person present
►►Revise Dietary programRevise Dietary program

25. PlacementPlacement
►► Fully equipped theatreFully equipped theatre
►► Monitoring of vital signs during placementMonitoring of vital signs during placement
►► Deep sedation (Deep sedation ( PropofolPropofol))
►► Perform full endoscopy before placementPerform full endoscopy before placement
►► BIB is filled with normal saline & 2,5 ml MBBIB is filled with normal saline & 2,5 ml MB
►► PostPost--op care in fully equipped recovery room, withop care in fully equipped recovery room, with
qualified nursingqualified nursing--staffstaff

28. VideoVideo

29. PostPost--placement careplacement care
►► Patient is discharged when fully awakePatient is discharged when fully awake
►► Patient is not allowed to drive after placementPatient is not allowed to drive after placement
►► Limited social activities for 3Limited social activities for 3--5 days after placement5 days after placement
►► Medication:Medication:
§§ PPI (? maintenance therapy)PPI (? maintenance therapy)
§§ DomperidonDomperidon oror MetoclopramideMetoclopramide
§§ Antispasmodic & Pain killer at nightAntispasmodic & Pain killer at night
►► Follow up starts directly in the first weekFollow up starts directly in the first week
§§ Possibility of consultation by telephone or at the clinicPossibility of consultation by telephone or at the clinic
§§ Nutrition & dieting programNutrition & dieting program

30. TeamworkTeamwork
►►GI specialist who handles the endoscopic partGI specialist who handles the endoscopic part,,
§§ Placement and removal of the system.Placement and removal of the system.
►►FollowFollow--up patients, assistance to change eatingup patients, assistance to change eating
patternpattern
Nutritionist / DieticianNutritionist / Dietician
►►Centers with a complete obesity program orCenters with a complete obesity program or
willingness to establish this.willingness to establish this.

31. BIB placement follow upBIB placement follow up
►► FollowFollow--up is organized for a period of 6 monthsup is organized for a period of 6 months
►► Importance of good follow upImportance of good follow up
►► Goal of good follow upGoal of good follow up
§§ ChangChangee thethe eatingeating behaviourbehaviour of the patientof the patient
§§ Diet analysis and dietary adviceDiet analysis and dietary advice

32. ImportanceImportance
of good followof good follow--upup
►►Better resultsBetter results // PatientPatient satisfactionsatisfaction
►►Better compliance of the patientBetter compliance of the patient
►►Less complicationsLess complications

33. Can we change the eatingCan we change the eating behaviorbehavior??
►► Patient will experience earlyPatient will experience early
satietysatiety
►► DietingDieting with BIBwith BIB for a longerfor a longer
period of timeperiod of time
►► Food will stay longer in theFood will stay longer in the
stomachstomach
►► Can eat normal food, but inCan eat normal food, but in
smallsmall portionsportions
YESYES

34. ►►Preparation: liquid diet 24 h before removal dayPreparation: liquid diet 24 h before removal day
►►Patient position & sedation is similar to placementPatient position & sedation is similar to placement
►►Use BIB removal instrumentsUse BIB removal instruments
§§ common removal instruments inadequatecommon removal instruments inadequate
BIB removalBIB removal

35. Balloon killerBalloon killer
BalloonBalloon ExtractorExtractor

37. Complications & their managementComplications & their management
►►Severe nauseaSevere nausea
►►DehydrationDehydration
►►DeflationDeflation
►►ObstructionsObstructions

38. Severe nauseaSevere nausea
►►Frequent during adaptation periodFrequent during adaptation period
§§ 80 % experience severe nausea combined with80 % experience severe nausea combined with vomiting ( 3 tovomiting ( 3 to
4 days max 1 week )4 days max 1 week )
►►Propulsive medicationPropulsive medication
§§ MotiliumMotilium,, PrimperanPrimperan IV, orIV, or ZofranZofran
►► PPI for 1 month or 6 month if refluxPPI for 1 month or 6 month if reflux
►► Analgesics, Antispasmodics,Analgesics, Antispasmodics, AnxiolyticsAnxiolytics

39. DehydrationDehydration
►►Standard procedure minimum 1 liter of normalStandard procedure minimum 1 liter of normal
saline IV during admission clinicsaline IV during admission clinic
►►At discharge, provide information on liquidAt discharge, provide information on liquid
intake and dietintake and diet
►►In case of severe dehydration, clinicalIn case of severe dehydration, clinical
hydration (IV saline)hydration (IV saline)

40. DeflationDeflation
►►Use MB for early detectionUse MB for early detection
►►Maximum placement period of 6 monthsMaximum placement period of 6 months
►►In case of doubt perform plain abdominal XIn case of doubt perform plain abdominal X--rayray

41. ObstructionObstruction
►►Only seen in case of previous open surgery orOnly seen in case of previous open surgery or
major laparoscopic surgerymajor laparoscopic surgery
►►Remove BIB always within 6 monthsRemove BIB always within 6 months

42. ContraindicationsContraindications
(Absolute)(Absolute)
►►Inflammatory diseasesInflammatory diseases
§§ OesophagitisOesophagitis, gastric or duodenal ulceration (PUD), gastric or duodenal ulceration (PUD)
§§ CrohnCrohn’’ss diseasedisease
►►Potentially Bleeding conditionsPotentially Bleeding conditions
§§ Oesophageal or gastricOesophageal or gastric varicesvarices
§§ TelangiectasiaTelangiectasia
§§ Current use of anticoagulants, steroids orCurrent use of anticoagulants, steroids or NSAIDNSAID’’ss
►►Pregnancy or breast feedingPregnancy or breast feeding
►►Previous gastric or duodenal surgeryPrevious gastric or duodenal surgery

43. ContraindicationsContraindications
(Relative)(Relative)
►►Large hiatus herniaLarge hiatus hernia
►►psychiatric disorderspsychiatric disorders
►►Alcoholism or drug addictionAlcoholism or drug addiction
►►Refuse of diet and behavior modification programRefuse of diet and behavior modification program
►►BMI < 30BMI < 30
►►Any kind of laparotomy in the pastAny kind of laparotomy in the past

44. LiteratureLiterature
►►Overview of publicationsOverview of publications
§§ BMI 30BMI 30--4040
§§ PrePre--operative in super obeseoperative in super obese
§§ Before elective surgeryBefore elective surgery

45. 3315 kg15 kg112828--5151n: 320n: 320HerveHerve.. BelBel
1115kg15kg334242n:111n:111StrobelStrobel.. NethNeth
121215 kg15 kg14144242n: 192n: 192GencoGenco.. ItIt
40%40%22222525--4242n: 174n: 174Napoleon.Napoleon. FrFr
18,6 kg18,6 kg3939n: 10n: 10HodsonHodson.. UKUK
15 kg15 kg332626--5757n:126n:126TotteTotte.. BelBel
3315 kg15 kg443636--7171n: 63n: 63Evans.Evans. UKUK
8814kg14kg112929--8181n:322n:322DoldiDoldi.. ItIt
15 kg15 kg223030--3838n: 23n: 23DargentDargent.. FrFr
9915kg15kg882525--7171n:84n:84ElewautElewaut.. BelBel
2828113030--8080n: 63n: 63RaemdonckRaemdonck.. BelBel
DeflationDeflation14kg14kgR: 5R: 5BMI 35BMI 35--6767n: 76n: 76CormillotCormillot.. ArgArg

46. ►►Between April 1998 and December 1999, 145Between April 1998 and December 1999, 145
patients received a BIBpatients received a BIB™™ SystemSystem
►►BMI range 30BMI range 30--3535
►►Weight loss sufficient in 80% of the cases, withWeight loss sufficient in 80% of the cases, with
no major complicationsno major complications
►►Conclusion: The BIB is a good help for theConclusion: The BIB is a good help for the
patient in term of diet and nutritional repatient in term of diet and nutritional re--
educationeducation
Dr B.Dr B. NapoleonNapoleon

47. PrePre--operative in super obeseoperative in super obese
Prof. R. WeinerProf. R. Weiner
►► Super obese patients (BMI > 60Super obese patients (BMI > 60))
§§ 15 patients15 patients
§§ Median Age 38.8Median Age 38.8
§§ Mean weight loss 18,1 kgMean weight loss 18,1 kg
§§ Mean time of placement 16,8 weeksMean time of placement 16,8 weeks
§§ Intolerance with 1 patientIntolerance with 1 patient
§§ Non compliance with 1 patientNon compliance with 1 patient
►► Conclusion:Conclusion:
§§ The BIB can improve conditions for laparoscopic surgeryThe BIB can improve conditions for laparoscopic surgery
in super obesein super obese patients.patients.

48. Before elective surgeryBefore elective surgery
Dr B.Dr B. WaeleWaele
►► First caseFirst case: Surgical hernia repair was repeatedly: Surgical hernia repair was repeatedly
postponed because of obesitypostponed because of obesity
§§ PrePre--operativeoperative BMI of 41,3BMI of 41,3
§§ At 6 MonthsAt 6 Months BMI of 34,0BMI of 34,0
§§ Hernia repair without postHernia repair without post--operative complicationsoperative complications
►► Second caseSecond case: Total hip: Total hip arthroplastyarthroplasty
§§ PrePre--operativeoperative BMI of 35,8BMI of 35,8
§§ At 6 MonthsAt 6 Months BMI of 29,9BMI of 29,9
§§ No postNo post--operative complications and recovered welloperative complications and recovered well
►► Conclusion: The BIB may contribute toConclusion: The BIB may contribute to preoppreop..
weight reduction before elective surgeryweight reduction before elective surgery

49. Prof.Prof. DoldiDoldi
►►145 patients since March 1998145 patients since March 1998
►►Mean weight before placementMean weight before placement 115,4 kg115,4 kg
►►Mean weight lossMean weight loss 14,4 kg14,4 kg
►►38 patients 6 months after BIB removal38 patients 6 months after BIB removal
§§ 44,7 % regained weight, mean of 8,4 kg44,7 % regained weight, mean of 8,4 kg
§§ 18,4 % showed no weight modification18,4 % showed no weight modification
§§ 36,8 % showed further weight loss, mean of 7,8 kg36,8 % showed further weight loss, mean of 7,8 kg

50. Dr. B.Dr. B. KrakampKrakamp (BMI 30(BMI 30 -- 40)40)
►►Prospective study 4 groups of each 10 patientsProspective study 4 groups of each 10 patients
§§ Group IGroup I Balloon and 1500 kcal diet butBalloon and 1500 kcal diet but
no additional supportno additional support
§§ Group IIGroup II Balloon with intensive therapyBalloon with intensive therapy
§§ Group IIIGroup III Sham with intensive therapySham with intensive therapy
§§ Group IVGroup IV No treatment, only advice toNo treatment, only advice to
follow dietfollow diet
►► Balloon placement was 6 monthsBalloon placement was 6 months
►► Follow up was 18 monthsFollow up was 18 months

51. ►►After 6 and 12 months a marked weight reductionAfter 6 and 12 months a marked weight reduction
was observed in group I and II when compared towas observed in group I and II when compared to
III and IV. Weight reduction was stable over timeIII and IV. Weight reduction was stable over time
and became statistical significant after 18 months.and became statistical significant after 18 months.
►►Results from group II were better than group IResults from group II were better than group I
►►Patients in group IV gained weightPatients in group IV gained weight
►►No Major complications occurredNo Major complications occurred

52. Dr.C.H.WahlenDr.C.H.Wahlen
►►320 patients320 patients 54 male and 266 female54 male and 266 female
►►BMI> 40 (46 pt.) BMI 35BMI> 40 (46 pt.) BMI 35--40 (114 pt.)40 (114 pt.)
►►BMI 30BMI 30--35 (160 pt.)35 (160 pt.)
►►Mean weight loss 14,7 kgMean weight loss 14,7 kg
►►Mean BMI reduction 4.85Mean BMI reduction 4.85
►► Conclusion: The BIB can be considered a safe andConclusion: The BIB can be considered a safe and
valid method for obtaining good weight loss, ifvalid method for obtaining good weight loss, if
associated with restrictive diet, a multiassociated with restrictive diet, a multi--
disciplinary approach and a good collaborationdisciplinary approach and a good collaboration
and motivation of the patient.and motivation of the patient.

53. Take Home Message
►►Good patient selection and follow up is neededGood patient selection and follow up is needed
►►BIB part of treatment algorithmBIB part of treatment algorithm
►►Average weight loss ranging from 15 kg to 30 kgAverage weight loss ranging from 15 kg to 30 kg
►►When used correctly a minimum of complicationsWhen used correctly a minimum of complications

54. THANK YOUTHANK YOU