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New competitively priced intra-gastric balloon

New competitively priced intra-gastric balloon
Soon to be available in India
Cheaper than Allergan BIB

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    Heliosphere balloon data Heliosphere balloon data Document Transcript

    • 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 studySciumè C. Annali Italiani di Chirurgica, 2009 mar-apr; 80(2):113-7Role of intragastric air filled ballon (Héliosphère bag) in severe obesity. Personalexperience.Trande P et al. Obesity Surgery, 2008 dec 10Efficacy, tolerance and safety of new intragastric air-filled balloon (Héliosphère 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):635-7Héliosphère bag in the treatment of severe obesity: preliminary experience.HELIOSCOPIE July 2010
    • 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.
    • [Role of intragastric air filled ballon (Heliosphere Bag) in severe obesity.Personal experience] [Article in Italian]Sciumè C, Geraci G, Pisello F, Arnone E, Mortillaro M, Modica G.Unità Operativa Semplice di Endoscopia Chirurgica, Università 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.
    • 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 18–65), mean basal BMI of 46±8 (range 35–58) wereBackground Overweight and obesity lead to serious health included, after providing informed consent. Weight and BMIconsequences, so that many strategies were recommended loss were evaluated in all patients.for preventing or curing this emerging problem. Treatments Results BMI decreased 4±3 (range +0.33/−11), weight lossare various: diet, physical activity, psychotherapy, drugs, was 11±9 kg (range +1/−29.5; 8.5%). 14/17 patientsand bariatric surgery. Moreover, during these years, the use maintain a BMI>35 at the time of balloon removal. Theof intragastric balloon (BIB) to treat obesity increased difference between initial weight and BMI was statisticallyrapidly, aimed to (1) reduce bariatric surgical risks; (2) significant (p=0.02 for weight and p<0.01 for BMI, T Studentreduce general surgical risks; (3) lead to a significant test). Tolerance was very good, limited only to some dyspepticreduction in the prevalence of cardiovascular diseases, symptoms during the first 3 days after insertion. Onediabetes, musculoskeletal disorders and some cancers. asymptomatic gastric ulcer was seen at the removal ofRecently, a new device inflated with air to reduce weight balloon. Only one severe adverse effect was registered at thehas been developed since 2004 (Heliosphere BAG). time of insertion (acute coronary syndrome in patient withMethods Between March 2006 and September 2006, in our chronic coronary disease). No serious technical problems wereunit, intragastric air-filled balloon insertion was performed noted at balloon insertion. Balloon removal was more difficultunder general anesthesia and endoscopic control. The balloons and successful in 15/17 cases (one distal migration and onewere removed after 6 months. We evaluated efficacy, patient led to surgery because of balloon fragmentation).tolerance, and safety of this technique. Seventeen patients Conclusion Intragastric air-filled balloon showed a good(eight men, nine women), with a mean age of 43±10 years profile of efficacy and tolerance. Weight loss appeared to be equivalent to other type of balloons. On the other hand, technical problems (especially at the time of removal) probablyP. Trande : A. Mussetto : V. G. Mirante : E. De Martinis :E. A. De Micheli linked to the device’s material, set a low safety profile.Internal Medicine and Gastroenterology Unit,New S’Agostino Hospital, Keywords Obesity . BMI . Intragastric balloon . Safety .Modena, Italy EfficacyG. Olivetti : R. L. ConigliaroDigestive Endoscopy Unit, New S’Agostino Hospital,Modena, Italy IntroductionA. Mussetto (*)Medicina Interna e Gastroenterologia, Obesity is a common chronic disorder that is affecting aNuovo Ospedale Civile S’Agostino Estense, gradually increasing part of the population in westernvia Giardini 1355,41100 Modena, Italy countries. The relationship between severe obesity ande-mail: alessandromussetto@gmail.com serious diseases (hypertension, type 2 diabetes, hyperlipid-
    • OBES SURGemia, sleep apnea, musculoskeletal disorders, and some Patients and Methodscancers) is now demonstrated [1]. To reduce the incidence ofmorbidities related to obesity, the World Health Organization Obese patients were evaluated by a multidisciplinary teamrecommended a decrease of 5% to 15% of body mass index (surgeon, gastroenterologist, dietician, and a psychologist).(BMI) [2]. Treatment options to achieve this goal are Weight and BMI loss were evaluated on all patients.various: diet, physical activity, psychotherapy, drugs, and Inclusion criteria were failure to achieve weight loss withinbariatric surgery. During these years, the use of intragastric a diet-control program and a BMI of at least 35 kg/m2balloon to treat obesity increased rapidly, aimed to obtain (grade II obesity). General exclusions criteria were:weight loss in non-morbid obesity and/or to reduce bariatric malignancy within the previous 5 years, pregnancy,surgical risks and general surgical risks [3, 4]. alcoholism and drug abuse, and psychosis. Specific contra- The intragastric balloons induce satiety by decreasing the indications were gastrointestinal lesions like neoplasias,capacity of the gastric reservoir, thereby reducing food intake ulcers, angiodyplasias, varices, grade C/D esophagitis, largeand leading to weight loss. The main balloon tested was water- hiatal hernia (more than 3 cm) and previous bariatricfilled (Bioenterics Intragastric Balloon—BIB) [5, 6]. Compli- surgery. Specifically informed consent was obtained by allcations and side effects were reported: low tolerance with patients. Heliosphere was performed under general anes-nausea and vomiting, damage to gastric mucosa (ulcers), and thesia and endoscopic control. If previous endoscopy ruledspontaneous deflation leading to small bowel obstruction. out abnormalities, then the balloon was inserted under general In order to limit digestive symptoms related to the anesthesia and endoscopic control. After standard endoscopyweight of the balloon, and to improve the tolerance of and lubrication of its sheath with lidocaine gel, the balloonintragastric balloons, a new device inflated with air has was passed through esophagus down to the stomach,been developed since 2004 (Heliosphere BAG, Fig. 1), positioned in the gastric fundus. The end of the connectionmade of smooth external pouch of biocompatible silicone catheter was positioned 1–2 cm below the cardia, according towith a radio-opaque marker. It weighs 30 g, compared to the manufacturer’s instructions. After this positioning, the600–800 g for a water-filled balloon. balloon was released from its silicone envelope then inflated Many studies have been reported, in order to evaluate with 960 cc of air. Once released, the balloons’ correctsafety, tolerance, and efficacy of intragastric water- and air- location beneath the cardia was checked endoscopically.filled balloon [7–9]. Less experience is registered with air- During the first day after insertion, intravenous salinefilled balloons. Here, we report a prospective analysis of plus omeprazole (40 mg) and N-butilbromuro hyoscineefficacy, tolerance and safety of intragastric air-filled (10 mg) was given to all patients. Ondasetron wasballoons (Heliosphere BAG) in 17 cases patients with administered only on demand, if nausea or vomitingmorbid and non-morbid obesity. occurred. In the first and second day, post-insertion patients began liquid diet and were discharged from hospital on day 3, with a protocol diet consisting of semi-liquid foods for the first week (800 kcal) then semi-solid until the removal (1,000 kcal). A specific and multidisciplinary follow-up was put into effect for all patients. The balloons were removed after 6 months, after complete air deflation. Endoscopic control was performed. Between March 2006 and September 2006, in our unit, intragastric air-filled balloon was implanted in 17 patients (nine women). The mean age was 43±10 years (range 18– 65), mean basal BMI 46±8 (range 35–58). We implanted the balloon in nine patients with a BMI>45, that were successively related to bariatric surgery, and in eight patients with a BMI between 35 and 45 (four patients presented poorly controlled hypertension and four failed to lose weight with diet and medical therapies). Results Balloon insertion was successful in all cases, with a meanFig. 1 Heliosphere BAG duration of 17 min (range 9–31); mean time of hospitalization
    • 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 41 M 140 130 −7.1 42 392 59 F 160.5 131 −18.4 58 493 41 M 161 162 +0.6 57 574 38 M 146 120 −17.8 49 425 42 M 158 159 +0.6 51,5 51,96 29 F 113 105.5 −6.6 45,2 42,37 38 F 121 120 +0.8 44,4 448 41 F 111 103 −7.2 35 32,59 58 F 109 98.5 −9.6 51 46,810 60 M 135 120 −11.1 39,8 35,411 50 M 116 102 −12.0 35 30,712 56 M 118 112 −5.0 39,4 37,413 24 F 117 100 −14.5 37 3214 37 F 124 107 −13.7 57 4615 32 F 128.5 120 −6.6 47 4416 48 M 163 140 −14.1 54 4617 35 F 99 96 −3.0 37 36was 3.24 days (range 2–7). No technical problems were noted frequent adverse side effects [10–12]. To reduce thisat balloon insertion. Only one clinical, severe adverse effect collateral 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 the BAG) respects those criteria. Moreover, its weight is 30 g,balloon, and one underwent surgery because of balloon compared to 600–800 g of liquid-filled balloons, and about riskfragmentation. No one of these two patients had other side of spontaneous deflation, is made of an internal polyurethaneeffects. envelope and an external silicone, to ensure air-tightness. Weight loss was evaluated on all patients. BMI Transient collateral effect like nausea and vomiting aredecreased 4±3 (range +0.33/−11), weight loss was 11± common, particularly in the first days after balloon9 kg (range +1/−29,5; 8,5%). Fourteen of 17 patients implantation: in our series nausea was reported in 17/17maintained a BMI≥35 at the time of balloon removal patients 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<0.01for BMI, T Student test). Only three of nine patients withmorbid obesity underwent successively bariatric surgery. Tolerance was very good, limited only to some dyspepticsymptoms during the first 3 days after insertion. Earlynausea was in fact reported in 17/17 patients, vomiting in12/17. These symptoms disappeared with “on demand”therapy and not registered after the first 3 days. An“endoscopic” side effect was registered at the removal ofballoon: one asymptomatic gastric ulcer was noted (Fig. 2).Early satiety sensation was experienced in all patients aftereating.DiscussionThe investigation about obesity and its relationship withserious diseases led, during the past years, to reconsider theuse of intragastric balloon. This procedure was in factabandoned about 20 years ago because of serious and Fig. 2 Gastric asymptomatic ulcer
    • OBES SURGmoderate weight loss was obtained in 15 of 17 patients. No 3. Mion F, Napoléon B, Roman S, et al. Effects of intragastric balloon on gastric emptying and plasma ghrelin levels in non-technical problems were noted at balloon insertion, while morbid obese patients. Obes Surg. 2005;15:510–6.balloon removal was more difficult. One patient showed 4. Melissas J, Mouzas J, Filis D, et al. The intragastric balloon—desufflation and distal migration of the balloon, while in smoothing the path to bariatric surgery. Obes Surg. 2006;16:897–one patient (5.8%), a surgical removal was necessary for 902. 5. Genco A, Bruni T, Doldi SB, et al. BioEnterics intragastricballoon fragmentation. balloon: the Italian experience with 2,515 patients. Obes Surg. This new device can be considered a good help for the 2005;15:1161–4.temporary treatment of morbid and non-morbid obesity. In 6. Genco A, Cipriano M, Bacci V, et al. BioEnterics intragastricour experience, the Heliosphere BAG showed only some balloon (BIB): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients.technical problems during its removal even if they can be Int J Obes (Lond). 2006;30:129–33.considered serious side effects. The results in terms of 7. Roman S, Napoleon B, Mion F, et al. Intragastric balloon for “nonweight loss and BMI loss were satisfactory and were morbid” obesity: a retrospective evaluation of tolerance andsimilar to other balloons [5, 7, 8]. efficacy. Obes Surg. 2004;14:539–44. 8. Al-Momen A, EL-Mogy I. Intragastric balloon for obesity: a In conclusion, intragastric air-filled balloon showed a good retrospective evaluation of tolerance and efficacy. Obes Surg.profile of efficacy and tolerance. On the other hand, technical 2005;15:101–5.problems (especially at the time of removal) probably linked 9. Forestieri P, De Palma GD, Formato A, et al. Heliosphere® bag into the device’s material, set a low safety profile. the treatment of severe obesity: preliminary experience. Obes Surg. 16:635–7. However, more controlled and larger studies are necessary 10. Mion F, Gincul R, Romane S, et al. Tolerance and efficacy of anto confirm the efficacy and the safety of this device. air-filled balloon in non-morbidly obese patients: results of a prospective multicenter study. Obes Surg. 2007;17:764–9. 11. Boyle TM, Agus SG, Bauer JJ. Small intestinal obstruction secondary to obturation by a Garren gastric bubble. Am JReferences Gastroenterol. 1987;82:51–3. 12. Ulicny KS Jr, Goldberg SJ, Harper WJ, et al. Surgical complica- 1. Melissas J, Christodoulakis M, Spyridakis M, et al. Disorders tions of the Garren–Edwards gastric bubble. Surg Gynecol Obstet. associated with clinically severe obesity: significant improvement 1988;166:535–40. after surgical weight reduction. South Med J. 1998;91:1143–8. 13. Schapiro M, Benjamin S, Blackburn G, et al. Obesity and the 2. WHO. Obesity: preventing and managing the global epidemic. gastric balloon: a comprehensive workshop. Florida: Tarpon Report of a WHO consultation on obesity. Geneva: WHO; 1998. Springs; 1987. March 19–21.
    • Obesity Surgery, 17, 764-769Tolerance and Efficacy of an Air-filled Balloon inNon-morbidly Obese Patients: Results of aProspective Multicenter StudyFrançois Mion1,2; Rodica Gincul; Sabine Roman1,2; Sylvain Beorchia3;Frank Hedelius4; Nicolas Claudel5; Roger-Michel Bory6; EtienneMalvoisin7; Frédérique Trepo1; Bertrand Napoleon61 Hospices Civils de Lyon, Fédération des Spécialités Digestives, Hôpital E. Herriot, Lyon;2 Université Claude Bernard Lyon 1, France; 3Clinique Sauvegarde, Lyon; 4Clinique Pasteur, StPriest; 5Polyclinique du Beaujolais, Arnas; 6Clinique Ste Anne-Lumière, Lyon; 7Fédération deBiochimie, Hôpital E. Herriot, Lyon, FranceBackground: Intragastric balloons have been pro- Key words: Obesity, ghrelin, human, intra-gastric balloonposed to induce body weight loss in obese subjects.Most studies were performed using liquid-filled bal-loons. Air-filled balloons may increase digestive tol-erance. Our goal was to study the tolerance and effi- Introductioncacy of a new air-filled intragastric balloon in non-morbidly obese patients. Methods: 32 patients were included, with a mean Overweight and obesity are increasing worldwide. ToBMI of 35.0 (range 30.1-40.0). The balloon was insert- reduce the incidence of morbidities related to obesity,ed under general anaesthesia, inflated with 800 ml of the World Health Organization recommended aair, and removed 4 months later. Tolerance and bodyweight were monitored until 12 months after removal. decrease of 5 to 15% of body weight, maintainedGhrelin levels were measured before balloon inser- throughout time.1 Currently, the therapeutic options totion, 1 and 4 weeks after, and before removal. achieve this goal are dietary restriction, physical activ- Results: Weight loss was significant at 1, 2 and 4 ity, pharmacological drugs, and bariatric surgery formonths after balloon insertion (6, 7 and 10 kg, respec- morbid obesity. The use of intragastric balloons hastively, P<0.001). Early removal of the balloon occurred been advocated,2-4 both as a way to obtain weight lossin 3 cases. 28 patients were contacted 12 monthsafter balloon removal: 2 had undergone gastric band- in non-morbid obesity,5 or before bariatric surgery ining; among the 26 remaining, the mean weight loss super-obese patients6-8 in order to decrease the mor-was 7 kg. 9 patients (30%) remained with a weight tality and morbidities related to these operations. Inloss >10%, and satisfaction with the method was 87% the 1980s, the first intragastric balloons available werefor these 9 patients, and 22% for the other patients air-filled polyurethane pouches with filling volumeswho had weight loss <10% (P<0.04). Fasting plasma from 200-500 ml. However, the high number of com-ghrelin levels increased at week 1 and 4 after ballooninsertion, and decreased at week 16 (P<0.001). plications resulted in abandonment of these devices, Conclusions. The air-filled intragastric balloon was and led experts to define the characteristics of an idealsafe. Its effect on weight loss appeared equivalent to intragastric balloon.9 Smoothness, durability andother balloons. 12 months after balloon removal, 30% radio-opacity were the main criteria; unsolved designof the patients maintained a weight loss >10%. variables were shape, filling medium and volume. Most recent results reported silicone intragastricCorrespondence to: F. Mion, MD, Fédération des SpécialitésDigestives, Hôpital E. Herriot, 69437 Lyon cedex 03, France. balloons inflated with liquid. However, these liquid-Fax: +33 4 72 11 75 78; e-mail: francois.mion@chu-lyon.fr filled balloons are frequently associated during the764 Obesity Surgery, 17, 2007 © Springer Science + Business Media, Inc.
    • Air-filled Balloon for Non-morbid Obesityfirst weeks after intragastric insertion with nausea Intragastric balloon insertion was performed underand vomiting.10-12 These symptoms of digestive intol- general anesthesia and endoscopic control: theerance may be related to the weight of the balloon Heliosphere BAG® was inflated with 800 ml of air.rather than to its size. In order to try to improve the All operators were expert endoscopists with previoustolerance of intragastric balloons, a new device inflat- animal and clinical experience with insertion anded with air to reduce its weight has been developed removal of the Heliosphere BAG®. The total time for(Heliosphere BAG®, Helioscopie, Vienne, France). balloon insertion and early complications wereIts design follows the Tarpon Spring criteria.9 For recorded. A systematic follow-up including dietarysmoothness and radio-opacity, the external pouch is counseling (to obtain a daily food intake of aroundmade of biocompatible silicone with a radio-opaque 1300 kcal), a systematic interview about signs ofmarker. Its durability has been improved by the use of digestive intolerance, physical examination, weightmultiple pouches with a combination of materials measurement, abdominal X-ray to detect balloonwith different properties. It weighs 30 g, instead of deflation, and quality-of-life questionnaire, was per-600-800 g for a liquid-filled balloon. A preliminary formed at week 1 and 4 after balloon insertion.report13 of this device in 10 morbidly obese patients, Blood samples for fasting total ghrelin levels werefound it difficult to insert, and spontaneous deflation obtained at week 1 and 4 after balloon insertion, andoccurred in 4 out of 5 patients. Since then, the design on the morning before balloon removal (week 16).of the Heliosphere BAG® has been modified, espe- Endoscopic balloon removal under general anesthe-cially by decreasing the size of the inflation valve, in sia and tracheal intubation (to avoid tracheal inhala-order to improve its insertion and removal. We report tion) was planned 4 months after balloon insertion.here the tolerance and efficacy results of a prospec- The total time for balloon removal and early compli-tive multicenter study with the modified Heliosphere cations were recorded. A final visit was planned 1BAG®, in 32 patients with non-morbid obesity. year after balloon removal for physical examination and body weight measurement. The patients’ satis- faction with the procedure was evaluated at that time.Patients and Methods Statistical AnalysesThirty-two patients (27 women), with a mean age of All results are expressed as mean (range), unless other-35 years (range 18-57), mean BMI of 35 (range 31- wise indicated. Temporal evolution of weight, quality40, <35 13 patients, ≤40 19 patients) were included, of life and ghrelin results were analyzed using ANOVAafter providing informed consent. The study had for repeated measurements. The PLSD Fischer’s testbeen approved by the CCPPRB Lyon B (local inde- was used for post-hoc comparisons. Analyses were per-pendent ethics committee). All subjects had failed formed using Statview® for Windows software (SASprevious attempts to lose weight by dietary restric- Institute Inc, v5.0, Cary, NC, USA).tions. Patients were excluded from the study if theyhad previous digestive surgery (except for gallblad-der removal and appendectomy), past history of gas-tric ulcer, or presence of a large hiatal hernia, severe Resultsesophagitis (≥class B of Los Angeles classification)or severe gastritis at the time endoscopy. Before bal- Technical Considerationsloon insertion, subjects were measured and Balloon insertion was successful in all cases, with aweighed, and blood samples were obtained for stan- mean duration of the procedure of 12 minutes (rangedard biochemistry, fasting glucose, cholesterol, 8-30). Difficulties were encountered in two cases intriglycerides, TSH, total ghrelin, aspartate and ala- opening the sheath, in three cases due to the impres-nine transaminases and gamma-glutamyl transferas- sion of an incomplete unfolding of the balloon, andes levels. A standardized dietary questionnaire and a in one case for the separation of the balloon from itsspecific quality-of-life questionnaire (IWQOL- insertion catheter. The mean diameter of the balloonLite)14 were administered. on X-ray at day 1 was 130 mm (range 113-142 mm). Obesity Surgery, 17, 2007 765
    • Mion et al Balloon removal was successful in all cases, but 120frequently more difficult than insertion, with a meanduration of the procedure of 21 minutes (range 5-80) 100 * *˚(P<0.0001 vs time for insertion). Two successive 80 Body Weight (kg)procedures were needed in one case (the balloon wasremoved with a larger endoscope with two operating 60channels). The balloon was estimated to be deflated 40by >50% in two patients. The upper GI endoscopyrevealed no lesion except for one gastric ulceration. 20The endoscopists reported difficulties: to introducethe needle of the catheter into the balloon in 1 case; 0 baseline week 4 week 16to grasp the balloon with the removal catheter in 6 Figure 1. Evolution of body weight after balloon implanta-cases (use of a rescue polypectomy snare in 3 cases); tion (mean + SD). *P<0.0001 vs baseline body weight;and to remove the balloon in 11 cases (10 cases at the °P= 0.0001 vs body weight at week 4.esophagogastric junction and 3 cases at the upperesophageal sphincter). These difficulties were foundto be related to the size of the inflation valve, which lower than their initial BW. In terms of BMI, 5has been further modified since that time. patients were <30 kg/m2 and 16 were 30.1-35 kg/m2. Only 7 patients remained had a BMI >35 kg/m2. NoBalloon Tolerance significant changes in blood pressure and blood bio- chemistry were noted before insertion and beforeIn three cases, patients requested balloon removalbetween 3 and 52 days after balloon implantation removal (week 16) of the balloon (data not shown).because of severe left upper quadrant abdominalpain (2 cases) and psychological intolerance (1 Quality of Lifecase). Abdominal pain was reported as moderate tosevere in 11 patients at week 1. Early nausea and The IWQOL-Lite score was significantly improvedvomiting were reported by 27 patients (84%): the at week 16 after balloon insertion compared to pre-mean duration was 3.1 days (range 1-8). Only 4 insertion values (Figure 2, P=0.0032). A significantpatients (13%) reported mild and intermittent improvement of the score was observed for theepisodes of vomiting at week 4. mobility (P=0.0027) and work (P=0.0234) dimen- sions, but not for the self-respect (P=0.074), sexWeight Loss (P=0.111) and social life (P=0.183) dimensions.Weight loss was evaluated on 28 of the 32 patients: 120one patient did not return for balloon removaldespite several phone calls and letters with acknowl- 100 baseline week 16edgment of reception, and the 3 patients in whom * IWQOL - Lite score 80balloon removal was performed earlier than plannedwere excluded from the analysis (per protocol). 60Body weight significantly decreased at week 4, 8and 16 after balloon insertion (Figure 1). The mean 40percentage of body weight (BW) loss at week 16 was * 209.3% (range 3-20). Nine patients lost >10% of BW *with the balloon. Twelve months after balloon 0 global mobility self-respect sex social life workremoval, 2 patients had undergone gastric banding in scorethe interval: among the 26 patients remaining, the Figure 2. IWOL-Lite score (global score and sub-scales)mean percentage of BW loss was 8.6% (range -5 to before balloon insertion (baseline) and before balloon removal (week 16). *P<0.05 vs baseline values.24). Eight patients (30%) maintained weight 10%766 Obesity Surgery, 17, 2007
    • Air-filled Balloon for Non-morbid Obesity Of the patients, 60% were satisfied with the bal- loon weighs 30 instead of the 600-800 g of liquid-filledloon method for weight loss, at 1 year after balloon balloons. One sham-controlled study using the air-filledremoval. Among the 8 patients with weight loss 500-ml Ballobes® balloon showed that this kind of bal->10%, 7 (88%) were satisfied with the method, loon was safe, but did not result in additional benefit inwhile only 4 of 18 patients (22%) with a weight loss terms of weight loss compared to a very low-caloric≤10% were satisfied (P=0.0358). diet.18 By increasing the size of the balloon (800 ml instead of 500), the objective was to improve efficacy.Ghrelin Results With regard to the risk of spontaneous deflation, this new air-filled balloon is made of an internalFasting total ghrelin plasma levels significantly polyurethane envelope and an external silicone, toincreased at week 1 and 4, and returned to pre-bal- ensure both air-tightness and smoothness.loon insertion values at week 16, before balloon In terms of efficacy on weight loss, our results areremoval (Figure 3). No correlation was found comparable to those reported in the literature withbetween the variations of ghrelin levels and body liquid-filled balloons.2,3,10-12,19,20 This weight lossweight loss (data not shown). was accompanied by a significant improvement in quality of life. This well-being related to weight loss may encourage patients to go on with their modified lifestyle and food habits acquired while the balloonDiscussion was in place in the stomach.21 Although the majori- ty of patients regained some weight 1 year after bal-Intragastric balloons have regained popularity for the loon removal, 30% of our patients retained a 10%treatment of obesity. After an initial period of interest in body weight loss at the end of follow-up.the early 1980s,15 the procedure was abandoned quick- With regard to BMI, it must be stressed that 12ly because of the frequency of severe adverse events, months after balloon removal, 5 patients were belowmainly intestinal obstruction due to balloon migration the obesity cut-off (BMI < 30), while only 7 still had abeyond the stomach.16,17 The criteria for an “ideal” bal- BMI ≥35. Intragastric balloons may thus be useful inloon were proposed in 1987.9 The new Heliosphere the long term in selected patients, as shown by otherBAG® respects those criteria: it is round, smooth and studies.2,4 In terms of digestive tolerance, our results incontains a radio-opaque marker. With regard to the fill- the first week appear to be similar to those reported ining of the balloon with air rather than with liquid, the the literature with the liquid-filled balloon, rangingidea was to reduce digestive intolerance of the balloon from 40 to 90%10,11,22 but without the dehydration orby decreasing its weight: the inflated Heliosphere® bal- other electrolytic problems usually described. Abdominal pain was the cause of early removal of the 3000 balloon in 2 cases: this observation has also been made with liquid-filled balloons.11,12 We did not find any 2500 endoscopic lesions a the time of balloon removal, 2000 except for one asymptomatic gastric ulcer. Small bowel obstructions, hemorrhagic ulcers and gastric perfora-Ghrelin (pg/ml) 1500 tions have been reported with liquid-filled balloons, albeit in much larger series than ours.3,11 Contrary to the 1000 study reported by Forestieri et al,13 we found this air- filled balloon safe, with only 2 cases of spontaneous 500 deflation of >50% at the time of balloon removal. The endoscopic insertion and removal techniques 0 baseline W1 W4 W16 are not difficult, but specific training is recommend- ed, to decrease the duration of the learning curve.Figure 3. Evolution of fasting plasma total gastrin levelsbefore balloon insertion (baseline), and 1 week (W1), 4 Some difficulties have been reported by the endo-weeks (W4) and 16 weeks (W16) after. (mean±SD). scopists in our study, especially for balloon removal.*indicates a P value <0.05 vs baseline values. Most problems were related to the size of the inflat- Obesity Surgery, 17, 2007 767
    • Mion et aling valve, resulting in difficult passage of the balloon 2. Mathus-Vliegen EM, Tytgat GN. Intragastric balloonthrough the cardia and the upper esophageal sphinc- for treatment-resistant obesity: safety, tolerance, andter. Since then, the valve design has been modified. efficacy of 1-year balloon treatment followed by a 1- Weight loss in obese patients is associated with year balloon-free follow-up. Gastrointest Endosc 2005; 61: 19-27.changes in levels of hormones involved in the regu- 3. Genco A, Bruni T, Doldi SB et al. BioEnterics intra-lation of satiety and energy metabolism.23 Blood lev- gastric balloon: The Italian experience with 2,515els of leptin are increased in obese subjects in rela- patients. Obes Surg 2005; 15: 1161-4.tion to the adipose tissue mass, and decreased with 4. Herve J, Wahlen CH, Schaeken A et al. Whatweight loss.24 Adiponectin levels are decreased in becomes of patients one year after the intragastric bal-obese subjects, and this decrease parallels the devel- loon has been removed? Obes Surg 2005; 15: 864-70.opment of insulin resistance.25 Ghrelin, a hormone 5. Mion F, Napoleon B, Roman S et al. Effects of intra-with orexigenic and adipogenic properties, primarily gastric balloon on gastric emptying and plasma ghre-secreted by the fundic glands of the stomach, is usu- lin levels in non-morbid obese patients. Obes Surgally decreased in states of excessive caloric intake.26 2005; 15: 510-6.Its secretion increases with diet-induced weight loss, 6. Alfalah H, Philippe B, Ghazal F et al. Intragastric bal- loon for preoperative weight reduction in candidatesas one of the compensatory responses of the body to for laparoscopic gastric bypass with massive obesity.an energy deficit.27 Our results showed a significant Obes Surg 2006; 16: 147-50.increase of plasma ghrelin levels during balloon 7. Milone L, Strong V, Gagner M. Laparoscopic sleevetreatment, probably related to the negative caloric gastrectomy is superior to endoscopic intragastric bal-balance during the first 4 weeks after balloon inser- loon as a first stage procedure for super-obese patientstion. Ghrelin levels before balloon removal returned (BMI ≥50). Obes Surg 2005; 15: 612-7.to the values before balloon insertion. 8. Melissas J, Mouzas J, Filis D et al. The intragastric In conclusion, this preliminary study shows that balloon - smoothing the path to bariatric surgery.the Heliosphere BAG® is safe, and efficient in terms Obes Surg 2006; 16: 897-902.of initial weight loss. In some patients, this initial 9. Schapiro M, Benjamin S, Blackburn G et al. Obesityweight loss is maintained 12 months after balloon and the gastric balloon: a comprehensive workshop. Tarpon Springs, Florida, March 19-21, 1987.removal. Specific training may be required for the Gastrointest Endosc 1987; 33: 323-7.endoscopic insertion and removal of the balloon. Its 10.Roman S, Napoleon B, Mion F et al. Intragastric bal-tolerance appears acceptable: this balloon may rep- loon for "non-morbid" obesity: a retrospective evalu-resent another therapeutic option for the multidisci- ation of tolerance and efficacy. Obes Surg 2004; 14:plinary management of obesity. A registry has been 539-44.implemented in France to monitor balloon safety 11.Sallet JA, Marchesini JB, Paiva DS et al. Brazilianand assess weight loss 1 year after balloon removal, multicenter study of the intragastric balloon. Obesin the setting of morbid obesity. Controlled trials Surg 2004; 14: 991-8.and studies looking at the mechanisms of action of 12.Al-Momen A, El-Mogy I. Intragastric balloon forthe gastric balloon are still needed. obesity: a retrospective evaluation of tolerance and efficacy. Obes Surg 2005; 15: 101-5.This study was undertaken by the Société Française 13.Forestieri P, De Palma GD, Formato A et al.d’Endoscopie Digestive (SFED). The design of the study and Heliosphere Bag in the treatment of severe obesity:data analyses were performed by the authors, independently preliminary experience. Obes Surg 2006; 16: 635-7.from the maker of the balloon (Helioscopie, Vienne, France). 14.Kolotkin RL, Crosby RD, Kosloski KD et al.Helioscopie provided the balloons for the study. Development of a brief measure to assess quality of life in obesity. Obes Res 2001; 9: 102-11. 15.Nieben OG, Harboe H. Intragastric balloon as an arti- ficial bezoar for treatment of obesity. LancetReferences 1982;1:198-9. 16.Boyle TM, Agus SG, Bauer JJ. Small intestinal1. WHO. Obesity: preventing and managing the global obstruction secondary to obturation by a Garren gas- epidemic. Report of a WHO consultation on obesity. tric bubble. Am J Gastroenterol 1987; 82: 51-3. Geneva: WHO; 1998. 17.Ulicny KS Jr, Goldberg SJ, Harper WJ et al. Surgical768 Obesity Surgery, 17, 2007
    • Air-filled Balloon for Non-morbid Obesity complications of the Garren-Edwards gastric bubble. 11: 519-23. Surg Gynecol Obstet 1988; 166: 535-40. 23.Gale SM, Castracane VD, Mantzoros CS. Energy18.Mathus-Vliegen EM, Tytgat GN, Veldhuyzen- homeostasis, obesity and eating disorders: recent Offermans EA. Intragastric balloon in the treatment of advances in endocrinology. J Nutr 2004; 134: 295-8. super-morbid obesity. Double-blind, sham-controlled, 24.Infanger D, Baldinger R, Branson R et al. Effect of crossover evaluation of 500-milliliter balloon. significant intermediate-term weight loss on serum Gastroenterology 1990; 99: 362-9. leptin levels and body composition in severely obese19.Doldi SB, Micheletto G, Perrini MN et al. Treatment subjects. Obes Surg 2003; 13: 879-88. of morbid obesity with intragastric balloon in associ- 25.Valsamakis G, McTernan Pg P, Chetty R et al. Modest ation with diet. Obes Surg 2002; 12: 583-7. weight loss and reduction in waist circumference after20.Wright TA. Intragastric balloon in the treatment of medical treatment are associated with favorable patients with morbid obesity. Br J Surg 2002; 89: 489. changes in serum adipocytokines. Metabolism 2004;21.Zago S, Kornmuller AM, Agagliati D et al. [Benefit 53: 430-4. from bio-enteric Intra-gastric balloon (BIB) to modi- 26.Druce MR, Small CJ, Bloom SR. Gut peptides regu- fy lifestyle and eating habits in severely obese patients lating satiety. Endocrinology 2004; 145: 2660-5. eligible for bariatric surgery]. Minerva Med 2006; 97: 27.Cummings DE, Weigle DS, Frayo RS et al. Plasma 51-64. ghrelin levels after diet-induced weight loss or gastric22.Totte E, Hendrickx L, Pauwels M et al. Weight reduc- bypass surgery. N Engl J Med 2002; 346: 1623-30. tion by means of intragastric device: experience with the bioenterics intragastric balloon. Obes Surg 2001; (Received October 10, 2006; accepted November 11, 2006) Obesity Surgery, 17, 2007 769
    • Obesity Surgery, 16, 635-637Heliosphere® Bag in the Treatment of Severe Obesity:Preliminary ExperienceP. Forestieri; G.D. De Palma; A. Formato; M. E. Giuliano; A. Monda;V. Pilone; A. Romano; S. TramontanoUniversità degli Studi di Napoli Federico II, Dipartimento Universitario di Chirurgia Generale,Geriatrica, Oncologica e Tecnologie Avanzate, Cattedra di Chirurgia Generale, Naples, ItalyBackground: Various intragastric balloons have been was 37.4 ± 13.4 (28.9-42.1) and %EWL was 29.1 ± 20.1used in obese patients for temporary weight loss. (9.0-57.4). BMI loss was 5.2 ± 13.1 (1.9-11.2) and meanRecently, a new balloon, the Heliosphere® Bag, was weight loss was 17.5 ± 16.2 kg (5-33).proposed. In a preliminary study, we evaluated the Conclusions: Although weight loss was satisfactory,safety and efficacy of this device. this device cannot be considered an advance for the Methods: The Heliosphere® Bag was used in 10 temporary treatment of morbid obesity. This balloonpatients, selected according to the guidelines for obe- still has some instrumental and technical problems thatsity surgery. The manufacturer’s instructions were fol- need to be solved: high rate of system failure at posi-lowed in positioning the device. Heliosphere® Bag tioning, high rate of spontaneous deflation, absence ofpositioning was performed, after diagnostic a marker such as methylene blue, and large size withendoscopy, under unconscious sedation. After place-ment, the balloon was slowly inflated with 840-960 cc of low pliability that cause significant patient discomfort.air, which gives the inflated final volume of 650-700 ccof air, as the air is compressed. On the first and second Key words: Morbid obesity, intragastric balloon, Heliosphere®post-treatment day, intravenous saline (30-35 ml/kg/d) Bag, weight reduction programwith omeprazole (20 mg/d), ondansetron (8 mg/d) andbutylscopolamine bromide (20 mg t.i.d.) were given toall patients. All patients from day 3 after placementbegan liquid diet and were discharged home on day 4 Introductionon a 1000 kcal diet (carbohydrate 146 g, lipid 68 g, pro-tein 1 g/kg ideal weight). After 6 months, theHeliosphere® Bag was removed. The patients were fol- The idea of using a gastric space-occupying device,lowed monthly, and complications and their treatment, giving satiety sensation, for the treatment of obesi-post-placement symptoms, BMI and %EWL wererecorded. Data were expressed as mean ± SD. ty, was first described by Nieben in 1982.1 This con- Results: From Sept-Dec 2004, 10 patients (5M/5F) cept arose from observations in patients with gastricunderwent Heliosphere® Bag placement, with age bezoars. During the years, several intragastric air-35.2 ± 15.7 years (17-49), BMI 43.3 ± 8.1 kg/m2 (35- filled free-floating balloons were proposed. After an51.2), and weight 126.8 ± 23.7 kg (98.4-148). initial enraptured period, a critical phase followedHeliosphere® Bag positioning was quite difficult in allpatients due to low pliancy and large size of the bag, because of the failure and/or high complication-ratecausing patient discomfort. System failure at time of of the Garren-Edwards, Ballobes, Taylor, andHeliosphere® Bag positioning was observed in 5/10 Wilson-Cook balloons.2-6 In the last few years, thepatients (50%). At time of removal, the Heliosphere® BioEnterics Intragastric Balloon (BIB®) was intro-Bag was not found in the stomach in one patient. In 3other patients, the balloon was found partially deflat- duced, with a very low complication rate and satis-ed. At the time of balloon removal after 6 months, BMI factory reported weight loss.7-11 More recently, a new intragastric balloon, the Heliosphere® Bag, wasReprint requests to: Prof. Pietro Forestieri, Università degli studidi Napoli Federico II, Via Pansini 5, Naples, Italy. proposed for obesity treatment. We evaluated theE-mail: michele.lorenzo@tin.it safety and efficacy of this new device, preliminarily.© FD-Communications Inc. Obesity Surgery, 16, 2006 635
    • Forestieri et alPatients and Methods g, and protein 1 g/kg ideal weight). Six months after placement, the Heliosphere® BagThe Heliosphere® Bag was implanted in 10 patients, was removed, after complete air-deflation by a ded-who were selected according to the guidelines for icated instrument inserted through the operatingbariatric surgery.12 These patients were evaluated inde- channel of the gastroscope. Then, the balloon waspendently by internists, dieticians and psychologists for grasped and gently withdrawn.preoperative selection. Specifically written informed Patients were followed monthly, and complica-consent was signed by all the treated patients. tions and their treatment, symptoms, BMI and per- The Heliosphere® Bag consists of a double bag cent excess weight loss (%EWL) were recorded.polymer balloon covered with a silicone envelope, an Data were expressed as mean ± standard deviation.introduction kit pre-connected to the intragastric bal-loon for air-filling, and the extraction kit consisting ofan emptying catheter and extraction forceps provided Resultsin separate packaging. Heliosphere® Bag positioningwas performed, after diagnostic endoscopy, underunconscious sedation. The first two balloons were From Sept-Dec 2004, 10 patients (5M/5F) underwentplaced under conscious sedation, but because of Heliosphere® Bag placement. Age was 35.2 ± 15.7patient discomfort and difficulties to insert the device, years (17-49), BMI 43.3 ± 8.1 kg/m2 (35-51.2), andall others underwent unconscious sedation. weight 126.8 ± 23.7 kg (98.4-148). The bag position- After lubrication of its protective sheath, the bal- ing was slightly difficult in all cases due to rigidity andloon was passed and positioned in the gastric fundus large size of the device causing patient discomfort.beneath the inferior esophageal sphincter. The end of System failure at time of Heliosphere® Bag posi-the connection catheter was positioned 1-2 cm below tioning was observed in 5/10 patients (50%). In 2the cardia, according to the manufacturer’s instruc- patients, it was impossible to unscrew the steel can-tions. After this positioning, the balloon was released nula after air-inflation of the balloon, and the connec-from its silicone envelope by cutting its safety loop tion tube was extracted with its mandril. In the otherand pulling on the end thread of a small chain. The 3 patients, rupture of the pulling thread that opens theinjection catheter was connected to a 60 cc syringe, balloon from its wrapper into the stomach wasand the balloon was slowly inflated with 960 cc of air, observed; in these 3 patients, the connection tube waswhich gives the final inflation volume of 700 cc of opened longitudinally to expose the remnant of theair, as the air is compressed (The balloon cannot be thread. A new balloon was inserted in the patientsrepositioned during the filling process without risking who had system failure at time of positioning.premature disconnection of the filling catheter). Once At the time of removal, the Heliosphere® Bag wasfilled, the stainless steel cannula was unscrewed and not found in the stomach of one patient. Abdominalthe needle within the catheter was removed, and then X-rays were negative. After 20 days, the patient hadthe balloon was released by pulling gently on the fill-ing-catheter while the balloon lay against the tip of repeat abdominal x-rays and underwent CT-scan.the endoscope or the inferior esophageal sphincter. Because the Heliosphere® Bag was not found, weOnce released, the balloons’ correct location beneath conclude that it passed in the stool. In 3 otherthe cardia was checked endoscopically. The balloon patients, the balloon was found partially deflated.is not radiopaque but the tip is radiopaque. At time of Heliosphere® Bag removal after 6 On the first and second day after insertion, intra- months, BMI was 37.4 ± 13.4 (28.9-42.1), %EWL wasvenous saline (30-35 ml/kg/d) with omeprazole (20 29.1 ± 20.1 (9.0-57.4), BMI loss was 5.2 ± 13.1 kg/m2mg/d), ondansetron (8 mg/d) and butylscopolamine (1.9-11.2), and weight loss was 17.5 ± 16.2 kg (5-33).bromide (20 mg t.i.d.) were given to all patients. All All the patients completed 6 months of treatmentpatients from day 3 post-placement began liquid without serious complications except nausea and vom-diet and were discharged from hospital on day 4, a iting in the first days after placement. Early satiety sen-roughly 1000 kcal diet (carbohydrate 146 g, lipid 68 sation was experienced in all patients after eating.636 Obesity Surgery, 16, 2006
    • A New Intragastric BalloonDiscussion ReferencesIn 1987, 75 international gastroenterology experts at 1. Nieben OG, Harboe H. Intragastric balloon as an arti-a Tarpon Springs meeting conceived the attributes ficial bezoar for treatment of obesity. Lancet 1982; 1:considered fundamental for a good intragastric bal- 198-9.loon.13 These attributes are a smooth surface with no 2. McFarland RJ, Grundy A, Gazet JC et al. The intra-external seams or protuberances which could cause gastric ballon: a novel idea proved ineffective. Br Jgastric mucosal ulcerations, a small and flexible Surg 1987; 74: 137-9.deflated balloon that can be inserted and removed 3. Ramhamadany EM, Fowler J, Baird IM. Effect of the gastric balloon versus sham procedure on weight lossunder direct endoscopic vision, filled with fluid for in obese subjects. Gut 1989; 30: 1054-7.weight, and made of a soft and highly elastic materi- 4. Mathus-Vliegen EMH, Tytgat GNJ. Intragastric bal-al. The Heliosphere® Bag in this study is of large size loons for morbid obesity: results, patient toleranceand not resilient enough, causing some difficulties and balloon life-span. Br J Surg 1990; 77: 77-9.and resistance during pharyngeal and esophageal 5. Hogan RB, Johnston JH, Long BW et al. A double blind,passage, with patient discomfort. Moreover, the randomised, sham controlled trial of the gastric bubbleHeliosphere® Bag is air-filled (floating), one of the for obesity. Gastrointest Endosc 1989; 35: 381-5.considered causes of low success and complications 6. Meshkinpour H, Hsu D, Farivar S. Effect of gastricof previous intragastric devices. Methylene blue bubble as a weight reduction device: a controlled,instilled into saline-filled balloons allows detection crossover study. Gastroenterology 1988; 95: 589-92.of balloon rupture, and its absence leads to exposing 7. Galloro G, De Palma GD, Catanzano C et al.patients to several disturbing diagnostic procedures. Preliminary endoscopic technical report of a new sili-One patient in this study was exposed to repeated X- cone intragastric balloon in the treatment of morbidray radiation due to the absence of any signal of bal- obesity. Obes Surg 1999; 9: 68-71.loon deflation and its passage in the stool. 8. Totté E, Hendrickx L, Pauwels M et al. Weight reduc- At the moment, this new device cannot be consid- tion by means of intragastric device: experience withered an advancement for the temporary treatment of the BioEnterics intragastric balloon. Obes Surg 2001;morbid obesity. The Heliosphere® Bag has some 11: 519-23.instrumentation and technical problems that need to 9. Roman S, Napoléon B, Mion F et al. Intragastric bal- loon for non-morbid obesity: a retrospective evalua-be solved: a high rate of system failure on positioning, tion of tolerance and efficacy. Obes Surg 2004; 14:high rate of spontaneous deflation, absence of an indi- 539-44.cator such as methylene blue, and large bag size with 10.Sallet JA, Marchesini JB, Paiva DS et al. Brazilianlow pliancy that cause high patient discomfort. The multicenter study of the intragastric balloon. Obesresults of this experience with the Heliosphere® Bag Surg 2004; 14: 991-8.in terms of mean %EWL (29.1), weight loss (17.5 kg) 11. Genco A, Bruni T, Doldi SB et al. The BioEntericsand BMI loss (5.2 kg/m2) were satisfactory. However, intragastric balloon: the Italian experience with 2,515its efficacy in weight loss should be proved by larger patients. Obes Surg 2005; 15: 1161-4.series. At the moment, we suggest that the use of the 12. Gastrointestinal surgery for severe obesity. NationalHeliosphere® Bag be limited to controlled clinical tri- Institutes of Health Consensus Development Conferenceals and only in referral centers for obesity treatment. Draft Statement. Obes Surg 1991; 1: 257-65.These studies should be conducted only after basic 13.Schapiro M, Benjamin S, Blackburn G, et al. Obesitystructural design modifications are completed and and the gastric balloon: a comprehensive workshop.have been shown to be effective. Tarpon springs, Florida, March 19-21, 1987. Gatrointest Endosc 1987; 33: 323-7.None of the authors has any commercial involvement with anyintragastric balloon. (Received December 13, 2005; accepted January 10, 2006) Obesity Surgery, 16, 2006 637
    • Syntheses of HELIOSPHERE articles De Castro ML. Sciumè C. Trande P. Mion F. Forestieri P. 33 Patients 18 Héliosphère® 50 17 32 10 15 Bioenteric® Follow-up 6 months 6 months 6 months 6 months 6 months Extraction 6 months 6 months 6 months 4 months 6 months Mean Age (years) - 38.1 (18-62) 43 (18 - 65) 47 (24 - 60) 35.2 (17-49) Initial BMI(kg/m²) 44.2 39.8 46 36.8 43.3 H : 4.6EFFICACITE BMI Loss (kg/m²) 5.9%* 4 5 5.2 B : 5.5 final BMI (kg/m²) - - - 34.6 37.4 H : 12.8 Weight Loss (kg) 16.8 11 13.1 17.5 B : 14.1 H : 27% Excess Weight Loss (%) - - 31% 29.1% B : 30.2% - Early : 84% Vomitting & nausea (%) 0% - - Late : 20% Mean time : 3.1 days Epigastric Pain (%) - 0 - Early : 31% -TOLERANCE H : 0% Early Extraction (%) 4 % (intolerance) 0% - - B : 20% H : - / 11% Deflated (%) / Migration (%) 4% (à 5 months) / 0% - / 6% 0% 30% / 10% (n=1) B : - / 0% Occlusion - - - - - Gastric Perforation (%) 0% 0% 0% 0% 0% Mortality (%)HELIOSCOPIE July 2010
    • International Federation for the Surgery of Obesity and metabolic disorders. XV World Congress Los Angeles / Long Beach , USA September 3 – 7, 2010HELIOSCOPIE Intragastric Balloon July 2010
    • International Federation for the Surgery of Obesity and metabolic disorders XIV World Congress Paris, France 2009 - O-099 FROMOVERWEIGHT TO SUPER-OBESITY: THE EFFICACY OF AIR FILLED BALLOON. A. GIOVANELLI - O-102 GASTRIC BALLOON EFFICIENCY ON WEIGHT LOSS (WL) WITH A MULTIDISCIPLINARY MEDICAL FOLLOWS UP. V. COSTIL - P-158 CARIBBEAN PROSPECTIVE MULTIDISCIPLINARY STUDY OF MANAGEMENT OF OBESITY WITH THE AIR-FILLED INTRAGASTRIC BALLOON. R. ROMNEY - P-259 AIR FILLED BALLOON - BRAZILIAN MULTICENTRIC STUDY. M. FALCAO - V-053 VIDEO DEMONSTRATION OF SAFE AND QUICK EXTRACTION OF HÉLIOSPHÈRE INTRAGASTRIC BALLOON. B. NAPOLÉONHELIOSCOPIE Intragastric Balloon July 2010
    • O-099 FromOverweight to Super-Obesity: The Efficacy of Air FilledBalloonPresenter: A. GiovanelliCliniche Humanitas Gavazzeni, Bergamo, ItalyBackground : Intragastric balloon may be used in overweight, morbidobesity and even in super-obesity as a pre-surgical weight-loss procedure.An interdisciplinary approach is related with the best results and weightloss maintenance.Methods : More than 800 air-filled balloon implantations have beenstudied till now. 602 treated patients data are available from multiple caseseries in Europe. Our aim is to assess the efficacy of the Heliosphereballoon in the three main indications: BMI below 35, BMI between 35 and50 and BMI above 50. All cases were recorded in the same database.Results : Balloon insertion and removal were successful in all theprocedures. Tolerance was excellent with less than 3% of early removalfor abdominal pain or psychological intolerance. At removal, the 167patients with BMI below 35 have lost an average of 12,2 kg±1,14 (62% ofexcess weight loss). The 353 patients with BMI between 35 and 50 havelost an average of 19,8 kg±1,2 (51,3% of EWL).The 63 patients with BMIabove 50 have lost an average of 15,9 kg±2,6 (BMI reduction of 5,88kg/m).Conclusion : Air-filled intragastric balloon may be used in weight losscontrol in each level of overweight or obesity. The procedure is efficientand safe. The new generation of Heliosphere intragastric balloon makesthe procedure even safer. To obtain the best results in a long term, amultidisciplinary nutritional and psychological follow-up is required.HELIOSCOPIE Intragastric Balloon July 2010
    • O-102 Gastric Balloon Efficiency on Weight Loss (Wl) with aMultidisciplinary Medical Follows UpPresenter: V. CostilCentre des médecins spécialistes de la Défense, Paris la Défense, FranceMethods : Since 30 months, 137 patients are included in a prospective,comparative and non-randomized study. The average of initial BMI was33.9 kg/m with the mean excess weight of 25.1 kg. Both types of gastricballoons were implanted for 6 months then removed. Throughout their useand after extraction, medical follow-up by a gastroenterologist, nutritionistand psychiatrist were done to helpmodify alimentary habits and behavior.Results : From the 108 extractions done, EWL was 54.7±1.0 %, WL was10.5± 1.5 kg and BMI decreasewas 4.1 kg/m. For the patients who arecompliant with the multidisciplinary follow-up, their weight still decreases(WL 16 kg after 12 months). Between both HELIOSPHERE® and BIB®gastric balloons, the weight loss was similar (9.6 kg vs 11.4 kg N.S.) butadverse events, such as nausea and vomiting (p<0.05) and retrosternalburning (15.6% vs 31.4% N.S.), were less with the HELIOSPHERE®. Foroverweight and obese people which are not indicated for bariatric surgery(BMI too low), gastric Balloon is a good way to lose weight significantly.Results show that the compliance during 12 months to a regularmultidisciplinary following-up is essential to avoid weight regain or tocontinue losing weight. However, if the longterm follow-up is neglected,weight regain can be significant.Conclusion : Gastric balloon can help overweight and obese patients, forwhom bariatric surgery may be contraindicated, to reduce weight.Behavior change is essential to avoid weight regain.HELIOSCOPIE Intragastric Balloon July 2010
    • P-158 Caribbean Prospective Multidisciplinary Study of Managementof Obesity with the Air-Filled Intragastric BalloonPresenter: R. RomneyHepatology-Gastroenterology, Baie-Mahault, GuadeloupeCo-authors: M. Durand 1, D. Siarras 2, S. Beauvarlet 3, S. Dagnaux 1, P. Bourgeois 1,R. Riahi 4, S. Clairville-Etzol 5, Y. Partouche 61Cabinet médical des Galeries de Houelbourg BAIE-MAHAULT Guadeloupe;2Cabinet de nutrition BAIE-MAHAULT Guadeloupe;3Cabinet de diététique BAIE-MAHAULT Guadeloupe;4Chirurgie Plastique Reconstructrice et Esthétique BAIE-MAHAULT Guadeloupe;5Cabinet de chirurgie digestive et générale Pointe-à-Pitre Guadeloupe;6Service de médecine de la Clinique les Eaux Claires BAIE-MAHAULT GuadeloupeBackground : In the French Caribbean, obesity has recently become aplague due to diminution of exercise, stressful life and occidental diet.40% of the adult population is considered overweight and children’sobesity has reached 10 % at the age of; 6The aim of the study was toassess the benefit of a multidisciplinary program to cure obesity in ourpopulation including the He´liosphere air balloon.Methods : From February 2007 to March 2009, 75 patients were followedby a multidisciplinary group and treated with Héliosphère. The group wascomposed of two gastroenterologists, a psychologist, a nutritionist and aphysical coach. Every patient signed up to see regularly each member ofthe group. The results are given in mean ± standards deviations.Results : 75 patients (6 M/69F, age: 36.6 years ± 2.06) have an averageinitial BMI of 39.43 kg/m ± 1.48. After 6 months follow-up, subject showedsignificant reduction in weight (15.18 kg ± 1.88), percent excess of massloss (42.49 % ± 5.44) and BMI loss (5,44 kg/m ± 0.68). There were fewsideeffects: epigastric pain (7%), no early removal. Minor complicationswere oesophagitis reflux (4%) and constipation (16%). 5 patientsexperienced spontaneous deflations after more than 6 months, only oneled to a smallbowel obstruction solved by a surgical approach. Weobserved 65% of improvement or resolution of comorbities.Conclusions : With a multidisciplinary approach, Heliosphere intragastricballoon has been effective to control obesity inducing an excess weightloss of almost 43 %. It was not associated with mortality nor majorcomplication during the 6 month period.HELIOSCOPIE Intragastric Balloon July 2010
    • P-259 Air Filled Balloon - Brazilian Multicentric StudyPresenter: M. FalcaoObesity Treatment and Surgery Nucleus - NTCO, Sao Paulo, BrazilCo-authors: M. Galvao Neto 2, E. Alves 1, A. Ramos 2, C. Martins 3, J. Campos 4, E.Ferraz 41Obesity Treatment and Surgery Nucleus - NTCO Salvador Brazil;2Gastro Obeso Center Sao Paulo Brazil;3San Rafael Hospital Salvador Brazil;4Federal University of Pernambuco Recife BrazilBackground : The intragastric balloon stills the main option as endoscopictreatment of obesity, besides its temporary manner. The air filled balloon(Helioscopie®, France) is a recent technical improvement that had beenproven its efficacy but more data still necessary to address it. A Brazilianmulticentric study was conducted among 4 bariatric surgery centers inorder to prospectively access data on safety and efficacyMethods : 236 patients (173 female), with weight from 72-156Kg(m=109,2Kg), BMI 34-52 (m=34,8) from January of 2005 to December of2008 were implanted. Balloon implant and explants runs under withanesthetic assistance and lasts 6 m in a specific multidisciplinary program.Result : There was significant weight loss (> 30%EWL) in all but 2patients, meaning 15-72%EWL (42%EWL). Implant time varies from 15-60 min (min= 26 min), explants time from 18-123 min (m=42 min). Theexplants times reduced significantly to a mean of 28 min (p<0,005) afterthe 10 first cases of each center. Adverse Events (AE) occurred on 35,1%of vomiting, 25% abdominal pain and 4,6% of Dehydration. Complicationshappened on 0,85% of balloon deflation. 0,42% of early removals, 0,42%of gastric ulcers, 3,81% of re-admitted patients and 2,97% of fungusballoon contamination. No implant or explants complication, no severe AEand no deaths were observed.Conclusion : Air filled intragastic balloon shows to be is a safe andeffective method of endoscopic bariatric treatment on a prospectivemulticentric trialHELIOSCOPIE Intragastric Balloon July 2010
    • V-053 Video Demonstration of Safe and Quick Extraction ofHeliosphere Intragastric BalloonPresenter: B. NapoléonHôpital Edouard Herriot, Lyon, FranceIntragastric balloons are efficient to obtain a significant weight loss inobese. Last generation of Heliosphere, intragastric balloons, filled with air,have major advances allowing an easiest retrieval. Nevertheless asystematic step by step procedure is needed to facilitate the extraction.This video demonstrates the most useful procedure to extract the balloonrapidly and safely.HELIOSCOPIE Intragastric Balloon July 2010
    • American Society for Metabolic and Bariatric Surgery 26TH Annual Meeting DALLAS, USA 2009 - GASTRIC BALLOON EFFICIENCY ON WEIGHT LOSS WITH A MULTIDISCIPLINARY MEDICAL FOLLOWS UP. V. COSTILHELIOSCOPIE Intragastric Balloon July 2010
    • International Federation for the Surgery of Obesity and metabolic disorders XIII World Congress Buenos Aires, Argentina 2008 - P155. AIR-FILLED INTRAGASTRIC BALOON: A PRE-SURGICAL DEVICE TO REDUCE BMI AND MORTALITY BEFORE GASTRIC BYPASS. A GIOVANELLIHELIOSCOPIE Intragastric Balloon July 2010
    • P155. AIR-FILLED INTRAGASTRIC BALOON: A PRE-SURGICALDEVICE TO REDUCE BMI AND MORTALITY BEFORE GASTRICBYPASS.A GiovanelliBackground: literature data shows gastric bypass mortality rate is > 2%for > 50 BMI but less than 1% for < 50 BMI. Air-filled intragastric balloonhave been proposed to induce body weight loss in obese subjects with a> 50 BMI.Methods: we report about a selected group of 882 patients from Italy,Spain, France and Dominican Republic till February 2007. F:M 4,2:1.mean age 37,7 (range 15-67). Two indications: unique treatment inBMI<35 (50,3%) and preoperative placement in morbid obesity withBMI>35 (33,2%) and superobesity BMI>50 (16,5%). In particular 20patients with BMI > 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 Balloon July 2010
    • AIR- AIR-FILLED INTRAGASTRIC BALLOON: A PRESURGICAL DEVICE TO REDUCE BMI AND MORTALITY BEFORE GASTRIC BYPASS Multicentric European experience: France – Italy –Spain A. Giovanelli – Humanitas Gavazzeni Bergamo Italy - www. gavazzeni.it – obesità@gavazzeni.it Literature data shows gastric bypass mortality rate is > 2% for > 50 BMI but 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 features Obesity Intragastric baloon After BAG group from France, Italy and Spain to Surgery 50.3% BMI < 35Among these, 602 were removed and the 33.2% BMI 35-50 10.3% BMI < 50 analysis concern the data on extraction mean 49.7 16.5% BMI > 50 16.5% BMI > 50 (range 45.7 49.9) mean BMI 55.4 6.2% BMI > 50 (range 50-76) Good weight loss Good weight loss in particular in in most of the patients with RESULTS super obesity mean BMI loss of 3.12 kg/m2 after BAG procedure Mean BMI reduced from 55.4 to 49.7 in 56% of the super obese with a Spanish serie followed a drastic diet mean 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. CONCLUSIONS Air-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.
    • International Federation for the Surgery of Obesity and metabolic disorders XII 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 NETOHELIOSCOPIE Intragastric Balloon July 2010
    • 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. Ospedale SESTO 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 – Nicolì 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 1 Italian multicentric* 67%F 33%M. experience with air filled intragastric balloon Age 37,7 (range 15-67). (EliosphereBAG) in BMI: 43,5 (range 29-76), 350 patients since 2005 is reported in a similar EW: 43,1 Kg (range 14-161) clinical and demographic 35% of comorbidity. features group even before bariatric surgery 37% balloons placement without anaesthesia, (IB test) than as unique all patients with a multidisciplinary approach, bariatric option. Removal after 6 months with endotraqueal intubation. Humanitas Gavazzeni, BERGAMO Ospedale DESENZANO DEL GARDA Spedali Civili, BRESCIA Ospedale, SESTO S. GIOVANNI Ospedale di MORTARA Results Policlinico, MONZA C.C. Città di PARMA Clinica S. Ambrogio, MILANO Ospedale di MANTOVA Istituto Clinico Villa Aprica, COMO BMI 39,6 (range 25-72) Ospedale di CANTU’ Ospedale S. Agostino, MODENA PEWL 33% (range 2,2-96%)Conclusions after 6 months.BAG may be a choose in body-weight Ospedale di PISTOIAcontrol.In morbid obesity the indication Complicationsare: no-operable patients, Clinica Ruschi, NAPOLI 1,2% early removal forgastrorestrictive-test, pre-surgery Asl, NAPOLI psychological or physical(especially in superobese). Azienda Ospedaliera Federico II, NAPOLI intolerance 23% nausea 4,3% severe vomitingIn severe overweight may be usedas 4,3% epigastric painunique treatment. 6,4% gastric failuresSelection criteria tend to a study a 0,6% intestinal migration andgood compliance to a new dietetic spontaneous evacuation nolife-style. death Results 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 term but a possible step. In severe overweight bag is a good therapeutic option.
    • International Federation for the Surgery of Obesity and metabolic disorders XII World Congress Sydney, Australia 2006 - 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-FILLED INTRAGASTRIC BALLON (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 MIONHELIOSCOPIE Intragastric Balloon July 2010
    • 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.HELIOSCOPIE Intragastric Balloon July 2010
    • 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
    • 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 Balloon July 2010
    • 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: 41.1±4.0 (29- 72), 73%F 27%M. Average age37.9±10. 35% balloons placement without anesthesia, all patients with amultidisciplinary approach, removal always with endotraqueal intubationafter 6 months.Results: Average BMI 36.6±3.8 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.HELIOSCOPIE Intragastric Balloon July 2010
    • 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.Hôpital E. Herriot, Rhône-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<0.001). Severe left upper quadrant abdominal pain lead to an earlyremoval of the balloon in 3 cases. No other complication occurred except fornausea and vomiting during the first week. 28 patients were contacted 12months after balloon removal: 2 had undergone gastric banding; among the26 remaining, the mean weight loss was 7 [-6 to 23] kg. 8 patients (30%)remained with a weight loss > 10%. The patients’ satisfaction with themethod was 87% for those 8, and only 22% for the others with a weight loss<10% (P<0.04).Conclusions: This newly designed air-filled balloon is safe, with nospontaneous deflation observed. Its efficacy seems equivalent to otherballoons in terms of weight loss (10 kg at 4 months). One year after balloonremoval, 30% of the patients maintained a weight loss greater than 10%.HELIOSCOPIE Intragastric Balloon July 2010
    • FROM OVERWEIGHT TO SUPER- GASTRIC BALLOON CARIBBEAN PROSPECTIVE AIR FILLED BALLOON - AIR-FILLED INTRAGASTRIC AIR FILLED INTRAGASTRIC AIR FILLED INTRAGASTRIC HELIOSPHERE INTRAGASTRIC BALLOON TOLERANCE AND EFFICACY PRIMARY EXPERIENCE WITH OBESITY: THE EFFICACY OF AIR EFFICIENCY ON WEIGHT MULTIDISCIPLINARY STUDY BRAZILIAN MULTICENTRIC BALOON: A PRE-SURGICAL BALLON (BAG) ITALIAN BALLON (BAG) ITALIAN INTRAGASTRIC AIR FOR OBESITY: OF AN AIR-FILLED BALLOON AIR FILLED INTRAGASTRIC FILLED BALLOON LOSS (WL) WITH A OF MANAGEMENT OF STUDY DEVICE TO REDUCE BMI AND MULTICENTRIC RESULTS MULTICENTRIC RESULTS BALLOON: OUR INITIAL COMPARATIVE STUDY WITH IN NON-MORBIDLY OBESE BALLOON CONFRONTED TO A Giovanelli (2009) MULTIDISCIPLINARY OBESITY WITH THE AIR- M Falcao (2009) MORTALITY BEFORE A. Giovanelli (2007) A. Giovanelli (2006) EXPERIENCE IN THE 420 PATIENTS: NEW PATIENTS: RESULTS OF A LIQUID INTRAGASTRIC 14TH WORLD CONGRESS OF MEDICAL FOLLOWS UP FILLED INTRAGASTRIC 14TH WORLD CONGRESS OF GASTRIC BYPASS 12TH WORLD CONGRESS OF 11TH WORLD CONGRESS OF DOMINICAN REPUBLIC GENERATION AIRFILLED VS PROSPECTIVE BALLOON LITERATURE IFSO, Paris, France V Costil (2009) BALLOON IFSO, Paris, France A. Giovanelli (2008) IFSO, PORTO, Portugal IFSO, SYDNEY, AUSTRALIA DK Ramirez (2006) LIQUID-FILLED. MULTICENTER STUDY DATA 14TH WORLD CONGRESS OF R Romney (2009) 13TH WORLD CONGRESS OF 11TH WORLD CONGRESS OF C Hermida (2006) F. Mion H. Claudez (2005) IFSO, Paris, France 14TH WORLD CONGRESS OF IFSO, Buenos Aires, Argentina IFSO, SYDNEY, AUSTRALIA 11TH WORLD CONGRESS OF Obesity Surgery, 2007; 17, 764- 13TH UNITED EUROPEAN IFSO, Paris, France IFSO, SYDNEY, AUSTRALIA 769 GASTROENTEROLOGY WEEK, COPENHAGEN, DENMARK 583 420 Patients 167with BMI < 35 137 75 236 882 350 195 64 192 Heliosphere 32 32 353 with 35 ≥ BMI > 49 228 BIB 63 with BMI ≥50 Follow-up 6 months 6 months 6 months 6 months 6 months 6 months 6 months 8 months 6 months 6 months 6 months Removal 6 months 6 months 6 months 6 months 6 months 6 months 6 months 8 months 6 months 4 months 6 months Average age ND ND 37 ± 2 ND 38 (15-67) 38 (15 - 67) 38 ± 10 36 37 (18 - 56) 47 (24 - 60) 35 (18 - 57) Initial BMI ND 33.9 39.4 ± 1.48 34.8 (34-52) ND 43.5 (29 - 76) 41.1 (29 - 72) 38.9 37.7 +/- 4.5 36.8 (30 - 44) 35 (30.1 - 40) (kg/m²) ND BMI Loss ND 4.1 5.4 ± 0.7 ND ND ND ND ND 5 (2 - 9) 3.3 (1.1 - 7.7) (kg/m²) 5.88 ND EFFICIENCY Final BMI ND ND ND ND ND 39.6 (25 - 72) 36.6 ± 3.8 32.4 ND 34.6 (25.8 - 50.8) 31.8 (24.6 - 38.1) (kg/m²) 12.2 ± 1.1 H: 24.7 +/- 10.9 Weight Loss 19.8 ± 1.2 10.5 ± 1.5 15.18 ± 1.9 ND ND ND ND 17.2 13.1 (6 - 27) 9 (3 - 20) (kg) 15.9 ± 2.6 B :24.3 +/- 9.9 62 EWL 51.3 54.7 ± 1.0 42.5 ± 5.4 42 (15-72) ND 33 (2.2 - 96) ND 51 ND 31 (0 - 86.7) 38.6 (10.7 - 114) (%) ND Vomitting & H : 12 84 > with BIB than with Vomiting : 4.3 Vomiting : 4.3 10 Nausea ND Héliosphère (p<0.05) ND 35.1 ND Nausea : 23 Nausea : 16 Mean time : 3.1 days (1 to Most related Adverse B : 40 8) (%) events : nausea. vomiting and abdominal pains Mean time : 2.7 days H:8 80 Epigastric Pains > with BIB than with ND 7 25 ND 4.3 4.3 31 Epigastric pains (1st (%) Héliosphère (NS) B : 46 week) TOLERANCE H : 0.7 Early removal <3 ND 0 0.42 ND ND ND ND ND ND (%) B : 8.1 1 No migration Migration (%) ND ND 0 ND 0.6 0 0 ND 0 removal > 6 months No gastrique perforation 1 spontaneus deflation 6.7 Deflation (%) ND ND 0.85 ND ND ND 0 ND 0 (4th month) without removal > 6 months migrationHELIOSCOPIE July 2010