1. HELIOSPHERE Scientific ArticlesDe Castro ML et al. Obesity Surgery ; 2010 Apr 15Efficacy, safety, and tolerance of two types of intragastric balloons placed in obesesubjects: a double-blind comparative studyScium C. Annali Italiani di Chirurgica, 2009 mar-apr; 80(2):113-7Role of intragastric air filled ballon (Hliosphre bag) in severe obesity. Personalexperience.Trande P et al. Obesity Surgery, 2008 dec 10Efficacy, tolerance and safety of new intragastric air-filled balloon (Hliosphre bag)for obesity: the experience of 17 cases.Mion F et al. Obesity Surgery, 2007; 17: 764-769Tolerance and efficacy of an air-filled balloon in non-morbidly obese patients: resultsof a prospective multicenter study.Forestieri P et al. Obesity Surgery, 2006; 16(5):635-7Hliosphre bag in the treatment of severe obesity: preliminary experience.HELIOSCOPIE July 2010

2. Efficacy, Safety, and Tolerance of Two Types of Intragastric Balloons Placed inObese Subjects: A Double-Blind Comparative Study.De Castro ML, Morales MJ, Del Campo V, Pineda JR, Pena E, Sierra JM, ArbonesMJ, Prada IR.Department of Gastroenterology, Universitary Hospital of Vigo (CHUVI), Vigo,Galicia, Spain, luisadecastroparga@mundo-r.com.AbstractThe intragastric balloon is a temporary treatment for obese patients. Fluid-filleddevices have shown efficacy and safety, and are widely used. Recently, althoughthere are no comparative studies between them, an air-filled balloon, Heliosphere(R)bag, has been proposed. Prospective, double-blind study in 33 patients with morbidand type 2 obesity: 23 female, 43.9 +/- 10 years, 120.3 +/- 17 kg, and body massindex (BMI) of 44.2 +/- 5 kg/m(2), placing 18 gastric balloons filled with 960 cm(3) ofair (Heliosphere(R) bag) or 15 balloons filled with 700 ml of saline (Bioenterics-BIB(R)). Both balloons were placed with conscious sedation and removed undergeneral anesthesia 6 months later. Intravenous drugs were given to controlsymptoms for 48 h. Patients were sent home on a 1000-kcal diet, multivitaminsupplements, and oral proton pump inhibitors, and were followed monthly.Complications, symptoms, weight, and quality of life evaluated by the GastrointestinalQuality of Life Index (GIQLI) scale were recorded. At 6 months, mean weight loss(12.8 +/- 8 vs 14.1 +/- 8 kg), BMI loss (4.6 +/- 3 vs 5.5 +/- 3 kg/m(2)) and percentexcess weight loss (27 +/- 16 vs.30.2 +/- 17) showed no significant differencesbetween both groups. At removal, two Heliosphere(R) bags were not found in thestomach, and four patients required extraction of the balloon by rigid esophagoscopyor surgery (p = 0.02). Tolerance was good in both groups, but early removal occurredin three BIB(R) (20%) due to vomits and dehydration. The GIQLI total scoresremained unchanged. Both balloons achieve a significant weight loss with goodtolerance in obese patients. Nevertheless, Heliosphere(R) bag has severe technicalproblems that need to be solved before recommending it. 3. [Role of intragastric air filled ballon (Heliosphere Bag) in severe obesity.Personal experience] [Article in Italian]Scium C, Geraci G, Pisello F, Arnone E, Mortillaro M, Modica G.Unit Operativa Semplice di Endoscopia Chirurgica, Universit degli Studi diPalermo. sciume@unipa.itAbstractINTRODUCTION: Obesity leads to serious health consequences, therefore manystrategies are recommended for preventing or curing this emerging problem.Treatments are various: diet, physical activity, psychotherapy, drugs and bariatricsurgery. In order to try to improve the tolerance of intragastric balloons, a new deviceinflated with air to improve weight loss was developed in 2004 (Heliosphere BAG).We report our personal experience about this tool. MATERIAL AND METHODS:Between January 2005 and December 2007, in our unit, 50 intragastric air filledinsertion were performed under analgosedation and endoscopic control. The balloonwas removed (24 hours) in two patients (4%) for acute intolerance. In other 2 patients(4%) the balloon was easily removed after 5 months because of prematuredesuflation, radiologically confirmed. The remnant 46 balloons were removed aftersix months. We evaluated efficacy, tolerance and the safety of this procedure.RESULTS: Forty one women and 9 men, with a mean age of 38.1 years (range 18-62), mean basal BMI of 39.8 (range 28-64) were included, after providing informedconsent. Weight and BMI loss were evaluated on all patients. BMI decreased 5.9%,weight loss was 16.8 kg. Tolerance was very good, limited only to some dispepticsymptoms during the first 2 days after insertion. No serious technical problems werenoted at balloon insertion. Balloon removal was very simple after correct desuflationafter the conclusion of learning curve (10 procedures). DISCUSSION: The aim totreat obesity before bariatric surgery is based on reduction of bariatric surgical risks,general surgical risks and the prevalence of cardiovascular diseases, diabetes,musculoskeletal disorders and some cancers. CONCLUSIONS: The intragastric airfilled balloon showed an acceptable profile of efficacy, good tolerance andimprovement of comorbidities after 6 months. 4. OBES SURGDOI 10.1007/s11695-008-9786-2 RESEARCH ARTICLEEfficacy, Tolerance and Safety of New Intragastric Air-FilledBalloon (Heliosphere BAG) for Obesity: the Experience of 17CasesPaolo Trande & Alessandro Mussetto &Vincenzo G. Mirante & Elvira De Martinis &Giampiero Olivetti & Rita L. Conigliaro &Enrico A. De MicheliReceived: 2 July 2008 / Accepted: 20 November 2008# Springer Science + Business Media, LLC 2008Abstract(range 1865), mean basal BMI of 468 (range 3558) wereBackground Overweight and obesity lead to serious healthincluded, after providing informed consent. Weight and BMIconsequences, so that many strategies were recommendedloss were evaluated in all patients.for preventing or curing this emerging problem. TreatmentsResults BMI decreased 43 (range +0.33/11), weight lossare various: diet, physical activity, psychotherapy, drugs, was 119 kg (range +1/29.5; 8.5%). 14/17 patientsand bariatric surgery. Moreover, during these years, the usemaintain a BMI>35 at the time of balloon removal. Theof intragastric balloon (BIB) to treat obesity increaseddifference between initial weight and BMI was statisticallyrapidly, aimed to (1) reduce bariatric surgical risks; (2)significant (p=0.02 for weight and p45, that weresuccessively related to bariatric surgery, and in eightpatients with a BMI between 35 and 45 (four patientspresented poorly controlled hypertension and four failed tolose weight with diet and medical therapies).ResultsBalloon insertion was successful in all cases, with a meanFig. 1 Heliosphere BAGduration of 17 min (range 931); mean time of hospitalization 6. OBES SURGTable 1 Change in weight and BMIPts Age (years) Sex (M; F) Weight pre-BAG (KG) Weight post-BAG (KG)Change in weight (%) BMI pre-BAG BMI post-BAG1 41M 140 1307.1 42 392 59F 160.5 131 18.4 58 493 41M 161 162+0.6 57 574 38M 146 120 17.8 49 425 42M 158 159+0.651,5 51,96 29F 113 105.56.645,2 42,37 38F 121 120+0.844,4448 41F 111 1037.2 3532,59 58F 10998.59.6 5146,81060M 135 120 11.139,8 35,41150M 116 102 12.0 3530,71256M 118 1125.039,4 37,41324F 117 100 14.5 37 321437F 124 107 13.7 57 461532F 128.5 1206.6 47 441648M 163 140 14.1 54 461735F99963.0 37 36was 3.24 days (range 27). No technical problems were noted frequent adverse side effects [1012]. To reduce thisat balloon insertion. Only one clinical, severe adverse effectcollateral effect, new criteria for an ideal balloon werewas registered at the time of insertion (acute coronary proposed [13]: roundness, smoothness, and with a radio-syndrome). Balloon removal was more difficult and success-opaque marker. The air-filled intragastric balloon (Heliosphereful in 15/17 cases. One patient showed distal migration of theBAG) respects those criteria. Moreover, its weight is 30 g,balloon, and one underwent surgery because of balloon compared to 600800 g of liquid-filled balloons, and about riskfragmentation. No one of these two patients had other sideof spontaneous deflation, is made of an internal polyurethaneeffects.envelope and an external silicone, to ensure air-tightness. Weight loss was evaluated on all patients. BMITransient collateral effect like nausea and vomiting aredecreased 43 (range +0.33/11), weight loss was 11common, particularly in the first days after balloon9 kg (range +1/29,5; 8,5%). Fourteen of 17 patientsimplantation: in our series nausea was reported in 17/17maintained a BMI35 at the time of balloon removalpatients and vomiting in 12/17. After 6 months, mild/(Table 1). The difference between initial weight and BMIwas statistically significant (p=0.02 for weight and p 50 underwent a gastric bypass after BAG procedure.The other ones treated with adjustable gastric band without mortality orpostoperative problems or are waiting for other bariatric steps. Ballooninsertion was successful in all cases and placed in 87% in sedation.97,2% removed six months later in sedation or general anaesthesiawithout evidence of problems.Results: Good weight loss: mean BMI reduced from 55,4 (range 50-76)to 49,7 (range 45,7-49,9) in 56% of the superobese with a mean BMIloss of 4,26 kg/m2. Good tolerance of the device with a lower early-removal. In particular, no death after laparoscopic gastric bypass arereported in our experience.Conclusions: Intragastric balloon is safe and an effective first-step insuper-obesity treatment. Risk of failure of laparoscopic approach,peroperative complications and mortality are reduced in the second stepsurgical procedures.HELIOSCOPIE Intragastric BalloonJuly 2010 28. AIR- AIR-FILLED INTRAGASTRIC BALLOON:A PRESURGICAL DEVICE TO REDUCE BMI AND MORTALITY BEFORE GASTRIC BYPASSMulticentric European experience: France Italy SpainA. Giovanelli Humanitas Gavazzeni Bergamo Italy - www. gavazzeni.it obesit@gavazzeni.it Literature data shows gastric bypass mortality rate is > 2% for > 50 BMIbut less than 1% for < 50 BMI. Air-filled intragastric balloon have been proposed to induce body weight loss in obese subjects with a > 50 BMI.782 patients till February 2007 are analyzed in asimilar clinical and demographic featuresObesity Intragastric baloonAfter BAG group from France, Italy and Spain to Surgery 50.3% BMI < 35Among these, 602 were removed and the33.2% BMI 35-50 10.3% BMI < 50 analysis concern the data on extractionmean 49.7 16.5% BMI > 50 16.5% BMI > 50 (range 45.7 49.9)mean BMI 55.46.2% BMI > 50 (range 50-76) Good weight loss Good weight loss in particular in in most of the patients withRESULTS super obesity mean BMI loss of 3.12 kg/m2 after BAG procedure Mean BMI reduced from 55.4 to 49.7 in56% of the super obese with a Spanish serie followed a drastic dietmean BMI loss of 4.26 kg/m2. (from 900 to 2,000 kcal/day- Median : Good tolerance of the device with a low1,000kcal/day), with a very good efficiency early-removal and low occurence of :complications. more than 26kg lost in 6 months 13.3% of super obese treated with BAG before surgery underwent a VLS gastric bypass without mortality .86.7% underwent a VLS adjustable gastric band or other gastrorestrictive procedures without surgical problems or mortality. CONCLUSIONSAir-filled intragastric balloon is safe and an effective first-step in super obesity treatment. Risk of failure of laparoscopic approach, preoperative complications and mortality are reduced in the second step surgical procedures. 29. International Federation for the Surgery ofObesity and metabolic disordersXII World Congress Porto, Portugal 2007 - P114. AIR FILLED INTRAGASTRIC BALLON (BAG) : ITALIAN MULTICENTRIC RESULTS. A.GIOVANELLI - V10. AIR-FILLED INTRAGASTRIC BALLOON FOR OBESITY TREATMENT. M P GALVAO NETOHELIOSCOPIEIntragastric BalloonJuly 2010 30. AIR FILLED INTRAGASTRIC BALLON (BAG) ITALIAN MULTICENTRIC RESULTS *A.Giovanelli, R.Sacco, L.Bertolani, A.CenturelliDepartment of surgery - Bariatric surgery Section, Humanitas Gavazzeni Hospital, Bergamo Italy - www.gavazzeni.it * Sacco R. Giovanelli A. Humanitas Gavazzeni BERGAMO - Mittempergher F. Spedali civili di BRESCIA - Bellini F. Ospedale di DESENZANO DEL GARDA - Faillace G.Iollo P. OspedaleSESTO SAN GIOVANNI - Pizzi P. Lochis D. Policlinico di MONZA - Bottani G. Gerosa E. Ospedale di MORTARA - Brenna A. Scarpis M. Istituto Clinico Villa Aprica COMO Azzola M. Rovelli Ospedale di CANTU- Micheletto G. Di Prisco F. Clinica S. Ambrogio MILANO Palandri P. Torelli Ospedale di PISTOIA Mechery F. Olivetti G.P. Ospedale S. Agostino di MODENA Francia L. Ospedale di MANTOVA Nicol F. USSL 8 Montebelluna De Lorenzi GF. Casa di Cura PARMA Forestieri P. AO universitaria Federico II NAPOLI Del Genio Cl. Ruschi NAPOLI Porcini ASL NAPOLI 1Italian multicentric*67%F 33%M. experience with air filled intragastric balloon Age 37,7 (range 15-67).(EliosphereBAG) inBMI: 43,5 (range 29-76), 350 patients since 2005 is reported in a similar EW: 43,1 Kg (range 14-161)clinical and demographic35% of comorbidity. features group even before bariatric surgery37% balloons placement without anaesthesia,(IB test) than as uniqueall patients with a multidisciplinary approach, bariatric option.Removal after 6 monthswith endotraqueal intubation. Humanitas Gavazzeni, BERGAMO Ospedale DESENZANO DEL GARDA Spedali Civili, BRESCIAOspedale, SESTO S. GIOVANNIOspedale di MORTARAResultsPoliclinico, MONZAC.C. Citt di PARMAClinica S. Ambrogio, MILANOOspedale di MANTOVAIstituto Clinico Villa Aprica, COMOBMI 39,6 (range 25-72)Ospedale di CANTU Ospedale S. Agostino, MODENAPEWL 33% (range 2,2-96%)Conclusions after 6 months.BAG may be a choose in body-weightOspedale di PISTOIAcontrol.In morbid obesity the indicationComplicationsare: no-operable patients,Clinica Ruschi, NAPOLI1,2% early removalforgastrorestrictive-test, pre-surgery Asl, NAPOLI psychological or physical(especially in superobese). Azienda Ospedaliera Federico II, NAPOLI intolerance23% nausea4,3% severe vomitingIn severe overweight may be usedas4,3% epigastric painunique treatment.6,4% gastric failuresSelection criteria tend to a study a0,6% intestinal migration andgood compliance to a new dieteticspontaneous evacuation nolife-style.deathResults show the same effectiveness on weight loss with a better psychological and physical tolerance of air filled BAG confronted with other balloons.Low incidence of gastric and systemic problems is performed in all our series. Follow-up role is remarked: carefully monitored by a multidisciplinar team of endoscopists, surgeons, dieticians and psychologists.Intragastric balloon (air or liquid filled) may not be considered a resolution for morbid obesity in long termbut a possible step. In severe overweight bag is a good therapeutic option. 31. International Federation for the Surgery ofObesity and metabolic disordersXII World Congress Sydney, Australia2006 - O31. INTRAGASTRIC BALLOON FOR OBESITY: COMPARATIVE STUDY WITH 420 PATIENTS: NEW GENERATION AIRFILLED VS LIQUID-FILLED. C HERMIDA - P14. HELIOSPHERE INTRAGASTRIC AIR BALLOON: OUR INITIAL EXPERIENCE IN THE DOMINICAN REPUBLIC. DK RAMIREZ - P76. HELIOSPHERE INTRAGASTRIC AIR BALLOON: OUR INITIAL EXPERIENCE IN THE DOMINICAN REPUBLIC. DK RAMIREZ - P106.AIR-FILLEDINTRAGASTRICBALLON (BAG): MULTICENTRIC PRELIMINARY RESULTS. A GIOVANELLI - P132. TOLERANCE AND EFFICACY EVALUATION OF AN AIR-FILLED INTRAGASTRIC BALLOON IN NON-MORBID OBESITY: 16 MONTHS FOLLOW-UP. F MIONHELIOSCOPIEIntragastric Balloon July 2010 32. O31. INTRAGASTRIC BALLOON FOR OBESITY: COMPARATIVESTUDY WITH 420 PATIENTS: NEW GENERATION AIRFILLED VSLIQUID-FILLED.C Hermida, I Cortijo, A Diaz, C Gonzalez-Perrino, C Arribas.Instituto Medico Europeo De La Obesidad, Madrid, Spain.Background: Intragastric balloons (IB) have been proposed as an aid to loseweight for obese patients. A study has been conducted to compare theeffectiveness of a new generation of airfilled balloon (Helioscopie, Vienne,France) to the previously available liquid-filled balloon (Inamed).Methods: From August 2004 to June 2005, 420 patients were included in arandomized prospective monocentric study. Group A: Air-filled balloon 900 cc Group B: Liquid-filled balloon 400-700 cc All patients hadmultidisciplinary assistance. Balloon placement and removal were doneunder general anesthesia and endotracheal intubation. Removal wasplanned after 6 months.Results: 420 patients (132 M/288 F, 192 A/228 B:) were included: Averageage 36.8 10.2 Range (18-56), Average BMI 37.7 4.5 kg/m2 Range(27.0-52.1). The two groups had similar demographic and clinicalcharacteristics. After 6 months of treatment: Mean weight loss: Group A:24.73 10.85, Group B: 24.33 9.94. Complications were: Nausea andvomiting: 12% group A vs 40% group B Epigastric pain: 8% group A vs46% group B Early removals: 0.7% group A vs 8.1% group B 8 slightesophageal erosions and one esophageal perforation during air-filledballoon removal learning curve.Conclusions: Our study shows: 1) Equal effectiveness on weight loss; 2)Better immediate tolerance with air-filled balloons; 3) Necessity of trainingfor air-filled balloon removal.HELIOSCOPIEIntragastric Balloon July 2010 33. P14. HELIOSPHERE INTRAGASTRIC AIR BALLOON: OUR INITIALEXPERIENCE IN THE DOMINICAN REPUBLIC.DK Ramirez, J Leon, A Inigo. Helioscopie,Clinica Corazones Unidos, Santo Domingo, Dominican Republic.Background: In Latin America, the obesity rate has tripled in the last decadealone; in the Dominican Republic, the rate of obesity is at 30% in males,34% in females and 49% in adolescents.We have added the Intragastric AirBalloon as an option to achieve weight loss in our Bariatric Unit program.Methods: In the last 15 months, 64 patients were included in our clinic toreceive an intragastric balloon for the treatment of their obesity (37 female,27 males), their average BMI was 38.9 kg/m2 and their average age was36.2 yrs. The balloon was placed with the help of general anesthesia(average time of placement 22 min). The follow-up until removal was at least6 months. For the removal, we used general anesthesia (average time 25min).Results: The balloon was removed after a mean time of 8 months.We didnot encounter gastric perforation, dilation, bleeding nor reflux problems. Themost common side effects were nausea/ vomiting and abdominal pain(average duration 2.7 days). 1 balloon was removed the third week forpsychological intolerance. At the time of removal, average BMI, weight lossand excess weight loss were respectively 32.4 kg/m2, 17.2 kg and 51%.Conclusion: Heliosphere intragastric balloon is an effective and safe optionto achieve weight loss. Besides, as 31% of the balloons were removed after8 months without any problem or side-effect, a longer period of treatmentshould be discussed.HELIOSCOPIE Intragastric Balloon July 2010 34. P76. HELIOSPHERE INTRAGASTRIC AIR BALLOON: OUR INITIALEXPERIENCE IN THE DOMINICAN REPUBLIC.DK Ramirez, J Leon, A Inigo. Helioscopie,Clinica Corazones Unidos, Santo Domingo, Dominican Republic.Background: In Latin America, the obesity rate has tripled in the last decadealone; and in the Dominican Republic, the rate of obesity is at 30% in males,34% in females and 49% in adolescents.We have added the IntraGastric AirBalloon as an option to achieve weight loss in our Bariatric Unit program.Methods: In the last 15 months, 64 patients were included in our clinic toreceive an intragastric balloon for the treatment of their obesity (37 females,27 males); their average BMI was 38.9 kg/m2 and their average age was36.2 yrs. The balloon was placed with the help of general anesthesia(average time of placement 22 min). The follow-up until removal was at least6 months. For the removal, we used general anesthesia (average time 25min).Results: The balloon was removed after a mean time of 8 months.We didnot encounter gastric perforation, dilation, bleeding or reflux problems. Themost common side-effects were nausea/ vomiting and abdominal pain(average duration 2.7 days). 1 balloon was removed the third week forpsychological intolerance. At the time of removal, average BMI, weight lossand excess weight loss were respectively 32.4 kg/m2, 17.2 kg and 51%.Conclusion: Heliosphere intragastric balloon is an effective and safe optionto achieve weight loss. Because 31% of the balloons were removed after 8months without any problem nor sideeffect, a longer period of treatmentshould be discussed.HELIOSCOPIE Intragastric BalloonJuly 2010 35. P106. AIR-FILLED INTRAGASTRIC BALLON (BAG): MULTICENTRICPRELIMINARY RESULTS.A Giovanelli, D Lochis, E Gerosa, F Bonfante, F Mittempergher, GP Olivetti,A Brenna, M Bisello, P Palandri, M Bertolani.Cliniche Humanitas Gavazzeni, Italy.Background: Multicentric experience with air-filled intragastric balloon(Heliosphere BAG) in 195 patients is reported since 2005.Methods: Report is about a similar clinical and demographic characteristicsgroup even before major surgical procedures (IB test) than as a uniquebariatric option. Average BMI: 41.14.0 (29- 72), 73%F 27%M. Average age37.910. 35% balloons placement without anesthesia, all patients with amultidisciplinary approach, removal always with endotraqueal intubationafter 6 months.Results: Average BMI 36.63.8 after 6 months. Very good compliance (nopsychological intolerance). Complications: no death, 16% nausea, 4.3%severe vomiting, 4.3% epigastric pain, 6.4% gastric failures, no intestinaldislocation, no early removal.Conclusion: Intragastric balloon may be an aid to lose weight occupying adefinite option in morbid obesity treatment: nonoperable patients, pre-surgery in super-obese, gastrorestrictivetest. In severe obesity the balloonmay be used as unique treatment. Selection criteria tend to thepsychological compliance to a new dietetic life-style. Preliminary resultsshow the same effectiveness on weight loss with a better tolerance of airfilled BAG confronted with liquid filled balloon BIB.Technical problemsespecially in the removal necessitate a training (in resolution with the newBAG generation with a more fable valve). Follow-up role is remarked:carefully monitored by a team of expert endoscopists, surgeons, dieticiansand psychologists. Intragastric balloon (airor liquid-filled) may not beconsidered a resolution for morbid obesity in the long-term but a possiblestep.HELIOSCOPIEIntragastric BalloonJuly 2010 36. P132. TOLERANCE AND EFFICACY EVALUATION OF AN AIR-FILLEDINTRAGASTRIC BALLOON IN NON-MORBID OBESITY: 16 MONTHSFOLLOW-UP.F Mion, B Napoleon, S Roman, S Beorchia, F Hedelius, N Claudel, RMBory.Hpital E. Herriot, Rhne-Alpes, France.Background: The goal of this study was to evaluate the tolerance and theefficacy of a new air-filled balloon, in non morbid obese patients.Methods: 32 patients (27 females, mean age 35 years), with a nonmorbidobesity for 8 6 years (mean BMI: 35 3), were included. A balloon(Heliosphere BAG, Helioscopie, France) was inserted under endoscopy,inflated with 800 ml of air, and removed 4 months later. A specific nutritiveprogram limited the daily caloric intake to 1300 Kcal. Weight loss andcomplications were evaluated.Results: Weight loss was significant at 1, 2 and 4 months after balloonimplantation (6 [range: 2-10], 7 [1-13] and 10 [3-20] kg, respectively,p 10%. The patients satisfaction with themethod was 87% for those 8, and only 22% for the others with a weight loss with BIB than with Vomiting : 4.3Vomiting : 4.3 10Nausea NDHliosphre (p with BIB than with ND 725 ND4.3 4.3 31Epigastric pains (1st(%)Hliosphre (NS) B : 46 week) TOLERANCEH : 0.7 Early removal 6 months No gastrique perforation1 spontaneus deflation 6.7 Deflation (%) ND ND0.85NDNDND 0ND 0(4th month) without removal > 6 monthsmigrationHELIOSCOPIE July 2010