international federation for the surgery of obesity and ...international federation for the surgery...

HELIOSCOPIE Gastric Banding

International Federation for the Surgery of Obesity and metabolic disorders

XII World Congress – Sydney, Australia – 2006

HELIOGAST : Anneau gastrique ajustable

ORAL PRESENTATION

- O54. HELIOGAST® BAND: OUR EXPERIENCE AFTER 1,756 POSITIONINGS. F BELLINI

- O57. LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING: LONG-TERM FOLLOW-UP IN A LARGE

SERIES C KARAINDROS

- O58. SYSTEMATIC FOLLOW-UP RESULTS IN SUPERIOR WEIGHT LOSS FOLLOWING

LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING N SIKAS

POSTER

- P21. LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING LOWERS BLOOD PRESSURE MONTHS

AFTER SURGERY H QUACH

- P22. LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING: DEALING INTRA-OPERATIVELY WITH A

TIGHT BAND AFTER BAND CLOSURE P DUMBRELL

- P53. LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING: PREDICTORS OF LAPAROSCOPIC

OPERATING TIME H QUACH

- P99. OUTCOMES AFTER LAPAROSCOPIC ADJUSTABLE GASTRIC BAND, USING SAGB

OBTECH® AND HELIOGAST BAND® F BELLINI

- P114.“PERIGASTRIC”VERSUS “PARS FLACCIDA” LAPAROSCOPIC TECHNIQUE: A

COMPARATIVE STUDY USING A NEW ADJUSTABLE GASTRIC BAND (HELIOGAST®) AS

TREATMENT OF MORBID OBESITY G SILECCHIA


- P135. SAFETY AND EFFECTIVENESS OF LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING IN

OBESE PATIENTS WITH “LOW” BODY MASS INDEX N SIKAS

- P138. HELIOSCOPIE (HAGA) GASTRIC BAND: WEIGHT LOSS RESULTS AND EXPERIENCE AT

ONE YEAR H QUACH

Published in : Obesity Surgery, 2006, volume 16, pages 972-992


O54. HELIOGAST® BAND: OUR EXPERIENCE AFTER 1,756 POSITIONINGS. F Bellini, N De Manzini, E Lattuada, M Boscarino, A Brenna, V Ceriani, P Pizzi, A Alonz, E Zanoni, A Della Barba. Ospedale Maggiore della Carità Novara, Policlinico Monza, Ospedale Multimedica Milano, C.D.C Villa Aprica Como, Clinica S. Rocco Ome, Fondazione IRCCS Policlinico Milano, Ospedali riuniti Trieste, Azienda Ospedaliera Desenzano del Garda -BS-, C.D.C Igea, C.D.C Beato Matteo, Italy. Background: Gastric banding is the most popular restrictive operation for the treatment of morbid obesity in Europe. The aim of this study is to give an account of our experience of the weight loss and complications after the positioning of the Heliogast® Band. Methods: From January 2001 to December 2005, we performed 1,756 laparoscopic gastric bandages. Preoperative data, postoperative weight loss, short and long term complications are analyzed. Results: Mean age was 41 for female and 39 for male with the range from 16 to 71 years. Preoperative mean BMI was 43.8 for male and 41.6 for female. No intraoperative or postoperative deaths. Conversion rate 1 (0.056%). Short-term complications: port site infection 12 (0.68%). Long-term complications: slippage: 49 (2.79%), intragastric migration 3 (0.17%), trocar hernias 7 (0.39%), port disconnections 3 (0.17%), port rotation 18 (1.02%), failure to lose weight 27 (1.53%), band removal 11 (0.62%), leak of the ring 3 (0.17%).We treated all the complications laparoscopically. Mean excess weight loss at 36 months was 55% for female, 53% for male. Global acceptable short/medium-term results with 85% of reducing 50% of the EWL. Conclusions: The study shows that laparoscopic banding is a good low-invasive instrument in the treatment of morbid obesity. With the Heliogast® Band, we achieved EWL >55%, with low complication rate (6.86%), no mortality, all the complications treated laparoscopically, global acceptable short/medium term results, with 85% of patients reducing 50% of the EWL and possibility of conversion to other procedure.


O57. LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING: LONG-TERM FOLLOW-UP IN A LARGE SERIES. C Karaindros, M Papaioannou, N Sikas, A Tassioulis, S Kiriakidis, P Giannakakis, V Sigalas, S Gabriel. Obesity Surgery Clinic, Athens Medical Center, Greece. Background: Laparoscopic adjustable gastric banding (LAGB) introduced the notion of minimally invasiveness, total adjustability and reversibility in bariatric surgery. The authors report longterm weight loss and complication rate after LAGB. Methods: From April 1998 to April 2005, 2948 morbidly obese patients underwent LAGB (pars flaccida technique, Heliogast® HAGA, Helioscopie) at our institution.The demographics included: 1975 (67 %) female and 973 (33 %) male, aged 43.4 (mean) years old, with an average preoperative weight of 121 kg and a mean BMI of 43.2 kg/m². Data on postoperative outcome and weight loss patterns at up to 7 years follow-up are presented. Results: The follow-up rate was 93 % and the mean follow-up time was 4.2 years. There was a 13.8 kg/m² decrease in mean BMI after 4.2 years. Mean excess weight loss was 30, 40, 49, 56, 58, 59 and 57 % at 1, 2, 3, 4, 5, 6 and 7 years respectively. 2580 (87.5 %) patients obtained an >50 % excess weight loss after initial treatment.Weight loss was insufficient (<50 % excess weight loss or weight regain >10% of weight loss) in 368 (12.5 %) patients. Mortality and conversion rates were 0. Complications were: gastric perforation 16 (0.54%), bleeding 8 (0.27 %), band leakage 6 (0.2 %), slippage 21 (0.7 %), erosion 6 (0.2 %). Conclusions: On the basis of long-term favorable outcome and weight loss, LAGB is a safe, effective and durable weight loss tool for the treatment of morbid obesity. It is very attractive to many obese patients and has the potential to be attractive to many more.


O58. SYSTEMATIC FOLLOW-UP RESULTS IN SUPERIOR WEIGHT LOSS FOLLOWING LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING. N Sikas, C Karaindros, M Papaioannou, A Tassioulis, G Kavadias, D Milonaki, S Gabriel. Obesity Treatment Center, Interbalkan Medical Center, Thessaloniki, Greece. Background: Laparoscopic adjustable gastric banding (LAGB) is an effective procedure in the management of morbid obesity. Its efficacy for weight loss is dependent on technical placement and frequent adjustments to maintain optimal individualized restriction. In this study, the objective was to investigate the hypothesis that systematic and thorough follow-up results in superior weight loss. Methods: Between April 2004 and March 2005, 200 morbidly obese patients underwent LAGB (Heliogast® HAGA, Helioscopie) at our institution and were randomized into two groups: In group A the patients were instructed to attend the follow-up clinic if weight loss was less than 4 kg/month or earlier if there was any complication and in group B the patients were asked to attend the clinic at least once a month regardless of weight loss or earlier in case of any concern. Follow-up and band adjustments were performed by two surgeons (NS and AT). The primary outcome measure was percentage of excess weight loss (%EWL) at 6 and 12 months. Results: At 6 months, %EWL in group A was 29.2 % and in group B 50 % (P<0.05). At 12 months, %EWL in group A was 36.4 % and in group B 68 % (P<0.05). In group A, the most common reasons for not attending the clinic were disappointment due to initial poor results, geographical distance and satisfactory weight loss. Conclusions: Systematic follow-up can improve significantly the rate of weight loss in morbidly obese patients undergoing LAGB. Patient motivation and surgeon commitment for long-term follow-up are critical for successful weight reduction following LAGB.


P21. LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING LOWERS BLOOD PRESSURE MONTHS AFTER SURGERY. H Quach, P Dumbrell, S Matthews, M Collins. Victorian Obesity Surgery Centre, VIC, Australia. Background: We studied the effect of gastric banding surgery on systolic blood pressure readings. Methods: Data was prospectively collected on 75 patients undergoing laparoscopic gastric banding using the HELIOSCOPIE HAGA™ band between the period of Jan 5, 2005 to Feb 3, 2006. Blood pressure readings (mmHg) were taken preoperatively and between 4-10 months after surgery. Results: 75% of patients experienced a drop in systolic BP (statistically significant), 15% had no change, and 10% had a rise. 57% of preoperative patients had high BP (ie. systolic BP >120mmHg). After surgery, only 28% had high BP (statistically significant). Of the patients with high systolic BP before surgery, 63% had normalized their blood pressure (statistically significant). Although 37% remained high, 56% had some fall in BP. 83% of patients were reviewed 4-7 months after surgery. 17% were reviewed at 8-10 months. Although more than half of the population were hypertensive on examination, only 29% of the population had reported a known history of hypertension. The number of hypertensive patients on medication fell from 64% to 45% after surgery. This was not found to be statistically significant. Improvements in BP postoperatively were best predicted by pre-operative BP (coefficient = -0.583), preoperative age (coefficient= 0.269) and %EWL (coefficient= -0.218). Conclusion: Gastric banding lowers systolic blood pressure postoperatively in 75% of patients at as early as 4 months.


P22. LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING: DEALING INTRA-OPERATIVELY WITH A TIGHT BAND AFTER BAND CLOSURE. P Dumbrell. Victorian Obesity Surgery Centre, VIC, Australia. Background: The situation of an overly tight band can become apparent during LAGB after the band is closed. We sought to see if unbuckling the band was advantageous in these situations and how easily it could be performed laparoscopically. Methods: Laparoscopic gastric banding was performed on 267 patients using the HELIOSCOPIE HAGA™ band between the period of Jan 5, 2005 to Mar 17, 2006. Intra-operative tight bands were identified. In these cases, the band was unlocked (a feature of the HAGA band). Further dissection of the fat pad using the ultrasonic dissector was performed before the band was relocked and routine anterior fixation of the band carried out. Results: 22 patients (8%) with tight bands were identified during surgery. All of them had high Waist-to-Hip ratios and 86% were male patients. All the tight bands encountered were due to a large volume of fat in the perigastric pad on the medial side of the gastro- esophageal junction preventing proximal stomach from being pulled up through the band for placement of gastro-gastric sutures into seromuscular tissue. The HAGA band was able to be easily unlocked laparoscopically. In all cases, an ultrasonic dissector was used for fat pad dissection before the band was relocked and the routine remainder of the operation was carried out. No problems with post-operative obstruction were encountered. Conclusion: A band that can be unbuckled easily laparoscopically is advantageous in this situation.


P53. LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING: PREDICTORS OF LAPAROSCOPIC OPERATING TIME. H Quach, P Dumbrell, S Matthews, M Collins. Victorian Obesity Surgery Centre, VIC, Australia. Background: The level of difficulty in laparoscopic placement of gastric bands can vary greatly from patient to patient. This is reflected in the duration of the operation.We sought to study factors that were associated with operating time. Methods: Data was prospectively collected on 121 patients who underwent laparoscopic gastric banding using the HELIOSCOPIE ™ (HAGA) band between the period of Jan 7, 2005 to Oct 24, 2005 by the same surgeon. The Laparoscopic Operating Time (LOT) was recorded for each operation as the time taken for the laparoscopic portion of the operation and analyzed against the following parameters: Gender (G), BMI, WHR (Waist to Hip Ratio), Neck Circumference (NC). Results: LOT was estimated to be 1.65 times longer in males than that for females. For each unit increase in BMI by 1, LOT was found to increase by a factor of 1.05. For each unit increase in WHR by 0.1, LOT would found to increase by a factor of 1.37. NC was an indirect predictor of operating time because of its direct relationship with gender. A model for the relationship between LOT and G, BMI, WHR could be expressed as: LOT (min) = 19 + exponential ( -2.71 + 0.5 G + 0.046 BMI + 3.118 WHR). Conclusion: Longer operating times were associated with patients who were male, with high BMI and high WHR.


P99. OUTCOMES AFTER LAPAROSCOPIC ADJUSTABLE GASTRIC BAND, USING SAGB OBTECH® AND HELIOGAST BAND®. F Bellini, P Pizzi, S Agradi. Chirurgia Apparato Digerente, Ospedale Desenzano, Italy. Background: The aim of the study is to identify the cause of the complications that we had after implanting two different laparoscopic band for the treatment of morbid obesity. Methods: In a non-randomized study, 2 consecutive groups were prospectively analyzed. A: 75 patients who received SAGBObtech ®; B: 758 patients who received Heliogast Band®. Results: From June 2000 to July 2001, we applied 75 SAGBObtech, and from August 2001 to December 2005 we applied 785 Heliogast. We did not have any differences in operating time or in intraoperative complications. However, the high amount of severe complications forced us to change the band. A) SAGB 75 patients: early complications 2 (1 early slippage of the fundus, 1 bleeding from acute ulcer in the site of the band placement). Late complications 31 (23 intragastric migrations, 8 infections in the porter site). We performed histological examination in each patients and we found residual of silicon in the gastric wall. B) HELIOGAST 785 patients: early complications 0, late complications 26 (15 port rotations, 1 intragastric migration, 10 slippages with gastric obstruction). Conclusions: Band erosion is related to the fact that synthetic material is placed around the stomach and probably the incidence is unlikely to decrease with technical changes. In our experience, changing the band ended in a remarkable improvement in band migration.


P114.“PERIGASTRIC”VERSUS “PARS FLACCIDA” LAPAROSCOPIC TECHNIQUE: A COMPARATIVE STUDY USING A NEW ADJUSTABLE GASTRIC BAND (HELIOGAST®) AS TREATMENT OF MORBID OBESITY. G Silecchia, C Boru, F Bellini, F Campanille, N Perrotta, R Paroni, F Greco, G Casella. University “La Sapienza”, Rome, Italy. Background: Two surgical techniques are actually used for the laparoscopic placement of gastric banding. In order to confront the “perigastric” with “pars flaccida” techniques, the experience of two Italian centers with the new adjustable gastric band (Heliogast® HAGA, Helioscopie, France) were analyzed. Methods: A retrospective comparative study was conducted in patients with BMI 35-60, age 18-60 years, no redo or concomitant surgery: in group I (50 patients from first center, mean age 43.4 ± 9.8 years, mean BMI 43.3 ± 5.9 kg/m2), the prosthesis was positioned using the “perigastric” technique. In group II (50 patients from second center, mean age 43 ± 9, mean BMI 42.5 ± 3.8), “pars flaccida” technique was used. All surgeons were over the learning curve and the band was used prior to the study for at least 12 months in each center. All prostheses were placed during 2004 (minimum 12 months follow-up). Initial BMI, EWL at 6 and 12 months, intraoperative, early and late complications and reintervention rate were analyzed. Results: Mortality, conversion, incidence of intraoperative and early complications were nil in both groups. No difference of initial BMI, EWL at 6 and 12 months, operative time and hospital stay was registered. Two pouch dilatations (4%) occurred in group I, successfully treated conservatively (deflation). One erosion (2%) occurred in group II (band removed). Conclusion: Both surgical techniques are effective, with no statistically significant difference for late complications. Heliogast® is safe and effective in the treatment of morbid obesity, using any of the 2 surgical techniques.


P135. SAFETY AND EFFECTIVENESS OF LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING IN OBESE PATIENTS WITH “LOW” BODY MASS INDEX. N Sikas, C Karaindros, M Papaioannou, A Tassioulis, G Kavadias, P Giannakakis, S Gabriel. Obesity Treatment Center, Interbalkan Medical Center, Thessaloniki, Attiki, Greece Background: Obese patients with a body mass index (BMI) <35 kg/m² are usually treated conservatively with poor results, since the majority will experience several failures and only 5% will maintain long-term satisfactory weight loss. Laparoscopic adjustable gastric banding (LAGB) is effective in obese (BMI >35 kg/m²) and morbidly obese patients (BMI >40 kg/m²) with co-morbidities, but is not routinely recommended in obese patients with BMI 30-35 kg/m². The authors investigated the safety and effectiveness of this surgical procedure in obese patients with low BMI. Methods: Patients were offered surgical treatment after thorough, multidisciplinary work-up. The study included 41 patients (35 female and 6 male) with a mean age of 39±10 years who underwent LAGB (Heliogast® HAGA, Helioscopie). Mean preoperative BMI and body weight were 32.5±1.6 kg/m² and 93±12 kg respectively. Weight-related co-morbidities were present in 10 patients (25%). All patients were followed for at least 18 months. Results: The operation was completed laparoscopically in all patients with no peri-operative complications. Mean operative time and hospital stay were 52±6 min and 12 hrs respectively. Mean percentage of excess weight loss (%EWL) at 12 and 18 months was 77±23 and 87±11 respectively. 33% reached a BMI of 25 kg/m2 after a mean period of 9±1.5 months. One patient developed band leakage requiring band replacement. Co-morbidities improved or resolved completely in all patients. Conclusions: Our results show that adjustable gastric banding is a safe and effective approach in obese patients with low BMI and should be recommended in carefully selected patients.


P138. HELIOSCOPIE (HAGA) GASTRIC BAND: WEIGHT LOSS RESULTS AND EXPERIENCE AT ONE YEAR. H Quach, P Dumbrell, S Matthews. Victorian Obesity Surgery Centre, VIC, Australia. Background: To study and report the weight loss results and experiences encountered after 1 year of using HELIOSCOPIE™ (HAGA) gastric band. Methods: Data was prospectively collected on 264 patients who underwent laparoscopic adjustable gastric banding (LAGB) using the HELIOSCOPIE™ (HAGA) band Jan 2005 to Mar 2005 using pars flaccida approach. Patients were followed-up at various stages after surgery. Results: 77% of patients were female. Mean age: 41. Mean weight: 120 kg. Mean BMI: 43 kg/m². At 5-6 months: mean weight loss (kg) = 20kg, %EWL = 42%, mean BMI loss= 7.5 kg/m2. At 11- 12 months: mean weight loss (kg)= 32 kg; %EWL = 61%; mean BMI loss = 11.5 kg/m²; mean circumference reductions were: neck loss = 3.7cm, waist loss = 21.7cm, hip loss = 19.6cm. 90% of patients stayed in hospital for 2 days after surgery. 4% for 1 day. 6% for 3 or more days. Complications included: 1 splenic hematoma, 5 basal atelectasis and or pyrexia postoperatively, 2 had anesthetic side effects. 3 superficial wound infections.10 patients (3.7%) had revision band surgery for reasons including band slippage and band leakage. 7 patients (2.6%) were re-operated for various tubing or reservoir problems. 1 patient had the band completely removed. There were no mortalities. Conclusion: At 1 year after LAGB, patients had experienced significant weight loss with minimal complications.

THE GASTRIC BAND: TRICKS AND TIPS TO

ACHIEVE SATISFACTORY EWL% AND LOW

PERCENTAGE OF COMPLICATIONS -

F BELLINI (2010)

XV WORLD CONGRESS OF IFSO - Los

Angeles, USA

SIX YEARS EXPERIENCE WITH

ADJUSTABLE GASTRIC BAND. ANALYSIS

OF 1582 CASES – 41 TONNES WEIGHT LOSS

-

N SIKAS (2010)


Angeles, USA

GASTRIC BAND: THE PERIGASTRIC “TWO-

STEP” TECHNIQUE TO PREVENT

POSTERIOR SLIPPAGE. RESULTS AFTER

3492 PATIENTS -

F BELLINI (2010)


Angeles, USA

RESULTS FROM A FRENCH PROSPECTIVE

MULTICENTRIC STUDY OF HELIOGAST

ADJUSTABLE GASTRIC BAND

S. MSIKA (2009)

XIV WORLD CONGRESS OF IFSO - Paris,

France

PRELIMINARY RESULTS WITH THE NEW-

HAGA (HELIOGAST SYSTEM) LAGB: STUDY

WITH FOUR DIFFERENT SURGICAL

TECHNIQUES

P. PIZZI (2009)


France

TREATMENT OF SEVERE OBESITY WITH

ADJUSTABLE GASTRIC BAND. ANALYSIS

OF 1350 CASES – 5 YEAR RESULTS

N. SIKAS (2009)


France

GASTRIC BAND: A MULTICENTRE,

INTERNATIONAL EXPERIENCE WITH THE

HELIOGAST® SYSTEM - THE FIRST 7,205

PATIENTS

F. BELLINI (2009)


France

ARE THE COMPLICATIONS OF THE

GASTRIC BAND RELATED TO THE

SURGEON? THE ITALIAN EXPERIENCE

WITH THE HELIOGAST SYSTEM.

OUTCOMES AFTER 3492 BANDS

F. BELLINI (2009)


France

NON-FIXED LAPAROSCOPICALLY PLACED

GASTRIC BAND: MY EXPERIENCE WITH

THE NEW HELIOGAST HAGA BAND

J. P. VOREUX (2009)


France

Patients2834

in 2 centers1582

3492

in 4 centers

250

in 25 centers154 1350 7205 3492 30

Follow up 87% at 5 years96,6% at

37 months ± 135 years 2 years 6 months 5 years 5 years 5 years 6 months

Mean Age ND 37 ± 11 ND NDMen : 38,7

Women : 40,337 42,2 ND ND

Initial BMI

(kg/m²)

Men : 42,6

Women : 41,945 ± 7

Men : 43,9

Women : 41,943,7

Men : 44,6

Women : 42,145 42,6 42,9 44,3 ± 2

BMI Loss

(kg/m²)ND ND ND

1 year : 8,3

2 year : 10,1ND ND ND ND ND

Final BMI

(kg/m²)ND ND

Men : 30,6

Women : 30,1ND

6 months

Men : 39,1

Women : 36,6

ND

1 year : 34,7

2 years : 32,2

4 years : 29,7

5 years : 29

1 year : 34,4

5 years : 30,8ND

Weight Loss

(kg)ND ND ND ND ND ND ND ND ND

Excess WL

(%)

Men : 53,6

Women : 55,1

1 year : 49%

2 years : 60%

3 & 4 years : 65%

5 & 6 years : 68%

54,51 year : 46%

2 years : 56%

6 months

Men : 27,7

Women : 31,3

1 year : 49%

2 years : 60%

3 years : 65%

4 years : 67%

5 years : 58,61 year : 48,6%

5 years : 56%36,3 ± 9

Other 6,77% poor weight loss

9,5% rate failure at 2 years

(explanted band, lost of follow

up...)

7,08% failure to lose weight

(<25%EWL)

7% failure to lose weight

(<25%EWL)7% failure to lose weight

Total Band

complications (%)5,5 5,5 5,6 ND 0 4,2 3 4,35 0

Slippage /

dilatation (%)4,5 4,3 4,5 9,4 0 3 2,7 3,9 0

Migration

erosion (%)0,5 1 0,5 0 0 1 0,3 0,45 0

Band Removal (%)0,5

(psychological intolerance)ND

0,6

(psychological intolerance)ND 0 ND ND 0,6 0

Band default (%) ND 0,2% band infection ND ND 0 0,2% band infection ND ND 0

Non specific

complications (%)

0,91 % trocar hernia

0,07% conversion

0,13% bleeding

0,13% stroma obstruction

0,11% trocar bleeding

0,1% conversion

1,1% trocar hernias

ND 00,15% bleeding

0,15% stroma obstructionND

1,3% trocar hernia0

Complication site

(%)1,3 ND 1,3 ND 0 ND 2,1 1,28 0

Other1 death due to massive

pulmonary embolism (22days

postoperativly)

1 year : 50% HTA resolved and

80% type 2 diabetes to

1 death (0,07%) due to massive

pulmonary embolism (22days

postoperativly)

4 reoperations

EF

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XV WORLD CONGRESS OF IFSO

Los Angeles, USA

XIV WORLD CONGRESS OF IFSO

Paris, France

HELIOSCOPIE July 2010

Patients

Follow up

Mean Age

Initial BMI

(kg/m²)

BMI Loss

(kg/m²)

Final BMI

(kg/m²)

Weight Loss

(kg)

Excess WL

(%)

Other

Total Band

complications (%)

Slippage /

dilatation (%)

Migration

erosion (%)

Band Removal (%)

Band default (%)

Non specific

complications (%)

Complication site

(%)

Other

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GASTRIC BAND: THE INTERNATIONAL

EXPERIENCE WITH THE HELIOGAST\

SYSTEM -

F. BELLINI (2008)

XIII WORLD CONGRESS OF IFSO - Buenos

Aires, Argentina

PARS FLACCIDA TO PERIGASTRIC “TWO

STEP TECHNIQUE”. NOT A RETURN TO THE

PAST BUT AN EVOLUTION. THE ITALIAN

EXPERIENCE WITH THE HELIOGAST\ BAND

IN 3104 PATIENTS -

F. BELLINI (2008)


Aires, Argentina

ADJUSTABLE GASTRIC BANDING, OUR

EXPERINCE ON 200 PACIENTES, 4 YEAR

AFTER THE SURGERY - J.A.V. CARIM (2008)


Aires, Argentina

LAPAROSCOPIC AND ENDOSCOPIC

SOLUTION IN LAGB COMPLICATIONS

P. PIZZI (2008)


Aires, Argentina

HELIOSCOPIE (HAGA & HAGE) GASTRIC

BAND: OUTCOME AND WEIGHT LOSS

RESULTS 12 MONTHS POST-OPERATIVELY

H. Quach (2007)

12TH WORLD CONGRESS OF IFSO - Porto,

Portugal

OUTCOME OF OBESITY-RELATED CO-

MORBIDITIES FOLLOWING LAPAROSCOPIC

ADJUSTABLE GASTRIC BANDING: A TWO-

YEAR PROSPECTIVE STUDY

N. Sikas (2007)


Portugal

HELIOGAST BAND®: MID- TO LONG-TERM

RESULTS IN 2,307 PATIENTS

F. Bellini (2007)


Portugal

FIRST RESULTS FROM THE FRENCH

MULTICENTRIC STUDY ON HELIOGAST®

GASTRIC BAND

S. Msika (2007)


Portugal

6360 3104

200

168 Allergan

32 Heliogast

(147 analyzed)

1980

1905 HAGA Heliogast

75 SAGB Obtech444 200 2307

250

(121 at 12 months)

5 years 5 years 4 years ND 1 year 2 years 4 years 1 year

ND ND ND ND 42 3541 Women

39,9 Men36,2 +/- 1,3

42,2Men : 43,9

Women : 41,945,5 ND ND 44

42,5 Women

42,8 Men43,5 +/-0,6

ND ND ND ND 11,3 ND ND 8,62 +/- 0,34

1 years : 34,4

5 years : 33,4

2 years : Men : 32

Women : 30,2

5 years : Men : 30,6

Women : 30,1

31,6 ND ND ND ND 35,06 +/- 0,5

ND ND ND ND 30 ND ND 23,51 +/- 1,02

1 years : 47,6

5 years : 56

2 years : 55

5 years : 5965,3 ND 60 65

59,2 Women

50,3 Men47,8 +/- 3,6

6,8% failure to lose weight 3,2% failure to lose weight

26,5% lost of follow up at 4

years

8,5% failure to lose weight and

Bypass procedure

3,1 3,7 12,9Heliogast : 2,1 %

Obtech : 21,3%3,4 4 4 ND

2,3 2,7 9,5Heliogast : 2 %

Obtech : 0 %ND 3 2,8 4,8

0,2 0,3 3,4Heliogast : 0,1 %

Obtech : 21,3 %ND ND 0,3 0

0,60,7

(psychological intolerance)12,2

Heliogast : nd

Obtech : 21,3 %ND ND 0,5 1,2

0 ND ND Obtech : 10,6 % infection ND 1 0,4 ND

0,4 % trocar hernia 0,6% trocar hernia ND ND ND ND ND ND

0,6 0,7 NDHeliogast : 1 %

Obtech : 0 %3,4 ND 1,6 3,2

0,07% conversion

0,07% trocar site bleeding

12TH WORLD CONGRESS OF IFSO

Porto, Portugal

XIII WORLD CONGRESS OF IFSO

Buenos Aires, Argentina


Patients

Follow up

Mean Age

Initial BMI

(kg/m²)

BMI Loss

(kg/m²)

Final BMI

(kg/m²)

Weight Loss

(kg)

Excess WL

(%)

Other

Total Band

complications (%)

Slippage /

dilatation (%)

Migration

erosion (%)

Band Removal (%)

Band default (%)

Non specific

complications (%)

Complication site

(%)

Other

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HELIOGAST® BAND: OUR EXPERIENCE

AFTER 1,756 POSITIONINGS.

F Bellini (2006)

11TH WORLD CONGRESS OF IFSO - Sydney,

Australia

SYSTEMATIC FOLLOW-UP RESULTS IN

SUPERIOR WEIGHT LOSS FOLLOWING

LAPAROSCOPIC ADJUSTABLE GASTRIC

BANDING

N Sikas (2006)


Australia

OUTCOMES AFTER LAPAROSCOPIC

ADJUSTABLE GASTRIC BAND, USING SAGB

OBTECH® AND HELIOGAST BAND®

F. Bellini (2006)


Australia


BANDING : LONG-TERM FOLLOW-UP IN A

LARGE SERIES

C. Karaindros (2006)


Australia

“PERIGASTRIC”VERSUS “PARS FLACCIDA”

LAPAROSCOPIC TECHNIQUE: A

COMPARATIVE STUDY USING A NEW

ADJUSTABLE GASTRIC BAND

(HELIOGAST®) AS TREATMENT OF MORBID

OBESITY

G SILECCHIA (2006)


Australia

SAFETY AND EFFECTIVENESS OF


BANDING IN OBESE PATIENTS WITH “LOW”

BODY MASS INDEX.

N SIKAS (2006)


Australia

HELIOSCOPIE (HAGA) GASTRIC BAND :

WEIGHT LOSS RESULTS AND EXPERIENCE

AT ONE YEAR

H.Quach (2006)


Australia

ERMS

EVALUATION DE L’EFFICACITE ET DE LA

SECURITE D’UN ANNEAU GASTRIQUE

AJUSTABLE.

Y. Claret

Le journal de ceoliochirurgie, 2005 ; 55, 68-73

1756

200

Group A : "free" follow up

Group B : regular follow up

75 SAGB Obtech

758 HELIOGAST

2948

100

Group 1 : 50 Perigastric

technique

Group 2 : 50 Pars Flaccida

technique

41 264 497

3 years 1 year ND 4 years 1 year 18 months 3 months 18 months

Men : 39

Women : 41ND ND 43,4

G 1 : 43,4

G 2 : 4339 41 38,4 +/- 11,4

Men : 43,8

Women : 41,6ND ND 43,2

G 1 : 43,3

G 2 : 42,532,5 +/- 1,6 43kg/m² 42,88 +/- 3,7

ND ND ND 13,8 ND ND 11,5 -9,86

ND ND ND ND ND ND ND

6 months : 37

12 months : 34,4

18 months : 33

ND ND ND ND ND ND ND ND

Men : 53

Women : 55

6 months: Group A : 29,2

Group B : 50

1 year: Group A : 36,4

Group B : 68

ND 56 nd1 year : 77 +/- 23

1,5 years : 878 +/- 1161 55,75

1,53% failure to lose weight Weight loss insuffisant in 12.5%

3 ND ND 1,6G 1 : 4

G 2 : 22,4 3,7 10,5

2,80% ND1,33

1,270,7

G 1 : 4

G 2 : 0ND ND 6,1

0,2 ND30,7

0,130,2

G 1 : 0

G 2 : 2ND ND 0

0,62 ND ND NDG 1 : 0

G 2 : 2ND ND 0

0,17% leak ND ND0,2 leak

0,7ND 2,4% leak ND 4,4

0,4% trocar hernia ND1,3

ND

0,54% gastric perforation

0,3% bleedingND ND 4,2 ND

1,88 ND10,7

1,9ND ND ND 2,6 0,8

0,06% conversion

11TH WORLD CONGRESS OF IFSO

Sydney, Australia


HELIOSCOPIE Intragastric Balloon

International Federation for the Surgery of Obesity and metabolic disorders

XII World Congress – Sydney, Australia – 2006

HELIOSPHERE : Ballon intragastrique

ORAL PRESENTATION

- O31. INTRAGASTRIC BALLOON FOR OBESITY: COMPARATIVE STUDY WITH 420 PATIENTS: NEW GENERATION AIRFILLED VS LIQUID-FILLED. C. HERMIDA

POSTER

- 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. MION

Published in : Obesity Surgery, 2006, volume 16, pages 972-992


O31. INTRAGASTRIC BALLOON FOR OBESITY: COMPARATIVE STUDY WITH 420 PATIENTS: NEW GENERATION AIRFILLED VS LIQUID-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 lose weight for obese patients. A study has been conducted to compare the effectiveness 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 a randomized prospective monocentric study. – Group A: Air-filled balloon – 900 cc – Group B: Liquid-filled balloon – 400-700 cc All patients had multidisciplinary assistance. Balloon placement and removal were done under general anesthesia and endotracheal intubation. Removal was planned after 6 months. Results: 420 patients (132 M/288 F, 192 A/228 B:) were included: Average age 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 clinical characteristics. After 6 months of treatment: Mean weight loss: Group A: 24.73 ± 10.85, Group B: 24.33 ± 9.94. Complications were: – Nausea and vomiting: 12% group A vs 40% group B – Epigastric pain: 8% group A vs 46% group B – Early removals: 0.7% group A vs 8.1% group B – 8 slight esophageal erosions and one esophageal perforation during air-filled balloon removal learning curve. Conclusions: Our study shows: 1) Equal effectiveness on weight loss; 2) Better immediate tolerance with air-filled balloons; 3) Necessity of training for air-filled balloon removal.


P14. HELIOSPHERE INTRAGASTRIC AIR BALLOON: OUR INITIAL EXPERIENCE 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 decade alone; 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 Air Balloon 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 to receive 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 was 36.2 yrs. The balloon was placed with the help of general anesthesia (average time of placement 22 min). The follow-up until removal was at least 6 months. For the removal, we used general anesthesia (average time 25 min). Results: The balloon was removed after a mean time of 8 months.We did not encounter gastric perforation, dilation, bleeding nor reflux problems. The most common side effects were nausea/ vomiting and abdominal pain (average duration 2.7 days). 1 balloon was removed the third week for psychological intolerance. At the time of removal, average BMI, weight loss and excess weight loss were respectively 32.4 kg/m2, 17.2 kg and 51%. Conclusion: Heliosphere intragastric balloon is an effective and safe option to achieve weight loss. Besides, as 31% of the balloons were removed after 8 months without any problem or side-effect, a longer period of treatment should be discussed.


P76. HELIOSPHERE INTRAGASTRIC AIR BALLOON: OUR INITIAL EXPERIENCE 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 decade alone; 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 Air Balloon 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 to receive 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 was 36.2 yrs. The balloon was placed with the help of general anesthesia (average time of placement 22 min). The follow-up until removal was at least 6 months. For the removal, we used general anesthesia (average time 25 min). Results: The balloon was removed after a mean time of 8 months.We did not encounter gastric perforation, dilation, bleeding or reflux problems. The most common side-effects were nausea/ vomiting and abdominal pain (average duration 2.7 days). 1 balloon was removed the third week for psychological intolerance. At the time of removal, average BMI, weight loss and excess weight loss were respectively 32.4 kg/m2, 17.2 kg and 51%. Conclusion: Heliosphere intragastric balloon is an effective and safe option to achieve weight loss. Because 31% of the balloons were removed after 8 months without any problem nor sideeffect, a longer period of treatment should be discussed.


P106. AIR-FILLED INTRAGASTRIC BALLON (BAG): MULTICENTRIC PRELIMINARY 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 characteristics group even before major surgical procedures (IB test) than as a unique bariatric option. Average BMI: 41.1±4.0 (29- 72), 73%F 27%M. Average age 37.9±10. 35% balloons placement without anesthesia, all patients with a multidisciplinary approach, removal always with endotraqueal intubation after 6 months. Results: Average BMI 36.6±3.8 after 6 months. Very good compliance (no psychological intolerance). Complications: no death, 16% nausea, 4.3% severe vomiting, 4.3% epigastric pain, 6.4% gastric failures, no intestinal dislocation, no early removal. Conclusion: Intragastric balloon may be an aid to lose weight occupying a definite option in morbid obesity treatment: nonoperable patients, pre-surgery in super-obese, gastrorestrictivetest. In severe obesity the balloon may be used as unique treatment. Selection criteria tend to the psychological compliance to a new dietetic life-style. Preliminary results show the same effectiveness on weight loss with a better tolerance of air filled BAG confronted with liquid filled balloon BIB.Technical problems especially in the removal necessitate a training (in resolution with the new BAG generation with a more fable valve). Follow-up role is remarked: carefully monitored by a team of expert endoscopists, surgeons, dieticians and psychologists. Intragastric balloon (airor liquid-filled) may not be considered a resolution for morbid obesity in the long-term but a possible step.


P132. TOLERANCE AND EFFICACY EVALUATION OF AN AIR-FILLED INTRAGASTRIC BALLOON IN NON-MORBID OBESITY: 16 MONTHS FOLLOW-UP. F Mion, B Napoleon, S Roman, S Beorchia, F Hedelius, N Claudel, RM Bory. Hôpital E. Herriot, Rhône-Alpes, France. Background: The goal of this study was to evaluate the tolerance and the efficacy of a new air-filled balloon, in non morbid obese patients. Methods: 32 patients (27 females, mean age 35 years), with a nonmorbid obesity 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 nutritive program limited the daily caloric intake to 1300 Kcal. Weight loss and complications were evaluated. Results: Weight loss was significant at 1, 2 and 4 months after balloon implantation (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 early removal of the balloon in 3 cases. No other complication occurred except for nausea and vomiting during the first week. 28 patients were contacted 12 months after balloon removal: 2 had undergone gastric banding; among the 26 remaining, the mean weight loss was 7 [-6 to 23] kg. 8 patients (30%) remained with a weight loss > 10%. The patients’ satisfaction with the method 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 no spontaneous deflation observed. Its efficacy seems equivalent to other balloons in terms of weight loss (10 kg at 4 months). One year after balloon removal, 30% of the patients maintained a weight loss greater than 10%.

FROM OVERWEIGHT TO SUPER-

OBESITY: THE EFFICACY OF AIR

FILLED BALLOON

A Giovanelli (2009)

14TH WORLD CONGRESS OF

IFSO, Paris, France

GASTRIC BALLOON

EFFICIENCY ON WEIGHT

LOSS (WL) WITH A

MULTIDISCIPLINARY

MEDICAL FOLLOWS UP

V Costil (2009)


IFSO, Paris, France

CARIBBEAN PROSPECTIVE

MULTIDISCIPLINARY STUDY

OF MANAGEMENT OF

OBESITY WITH THE AIR-

FILLED INTRAGASTRIC

BALLOON

R Romney (2009)


IFSO, Paris, France

AIR FILLED BALLOON -

BRAZILIAN MULTICENTRIC

STUDY

M Falcao (2009)


IFSO, Paris, France

AIR-FILLED INTRAGASTRIC

BALOON: A PRE-SURGICAL

DEVICE TO REDUCE BMI AND

MORTALITY BEFORE

GASTRIC BYPASS

A. Giovanelli (2008)


IFSO, Buenos Aires, Argentina

AIR FILLED INTRAGASTRIC

BALLON (BAG) ITALIAN

MULTICENTRIC RESULTS



IFSO, PORTO, Portugal


BALLON (BAG) ITALIAN

MULTICENTRIC RESULTS



IFSO, SYDNEY, AUSTRALIA

HELIOSPHERE

INTRAGASTRIC AIR

BALLOON: OUR INITIAL

EXPERIENCE IN THE

DOMINICAN REPUBLIC

DK Ramirez (2006)



INTRAGASTRIC BALLOON

FOR OBESITY:

COMPARATIVE STUDY WITH

420 PATIENTS: NEW

GENERATION AIRFILLED VS

LIQUID-FILLED.

C Hermida (2006)



TOLERANCE AND EFFICACY

OF AN AIR-FILLED BALLOON

IN NON-MORBIDLY OBESE

PATIENTS: RESULTS OF A

PROSPECTIVE

MULTICENTER STUDY

F. Mion

Obesity Surgery, 2007; 17, 764-

769

PRIMARY EXPERIENCE WITH


BALLOON CONFRONTED TO

LIQUID INTRAGASTRIC

BALLOON LITERATURE

DATA

H. Claudez (2005)

13TH UNITED EUROPEAN

GASTROENTEROLOGY

WEEK, COPENHAGEN,

DENMARK

Patients

583

167with BMI < 35

353 with 35 ≥ BMI > 49

63 with BMI ≥50

137 75 236 882 350 195 64

420

192 Heliosphere

228 BIB

32 32

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

(kg/m²)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)

BMI Loss

(kg/m²)

ND

ND

5.88

4.1 5.4 ± 0.7 ND ND ND ND NDND

5 (2 - 9) 3.3 (1.1 - 7.7)

Final BMI

(kg/m²)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)

Weight Loss

(kg)

12.2 ± 1.1

19.8 ± 1.2

15.9 ± 2.6

10.5 ± 1.5 15.18 ± 1.9 ND ND ND ND 17.2

H: 24.7 +/- 10.9

B :24.3 +/- 9.9

13.1 (6 - 27) 9 (3 - 20)

EWL

(%)

62

51.3

ND

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)

Vomitting &

Nausea

(%)

ND> with BIB than with

Héliosphère (p<0.05)ND 35.1 ND

Vomiting : 4.3

Nausea : 23

Vomiting : 4.3

Nausea : 16

H : 12

B : 40

84

Mean time : 3.1 days (1 to

8)

10

Epigastric Pains

(%)ND

> with BIB than with

Héliosphère (NS)7 25 ND 4.3 4.3

H : 8

B : 46

31

80

Epigastric pains (1st

week)

Early removal

(%)<3 ND 0 0.42 ND ND ND ND

H : 0.7

B : 8.1

ND ND

Migration (%) ND ND1

removal > 6 months0 ND 0.6 0 0 ND 0

No migration

No gastrique perforation

Deflation (%) ND ND6.7

removal > 6 months0.85 ND ND ND 0 ND 0

1 spontaneus deflation

(4th month) without

migration

Most related Adverse

events :

nausea. vomiting and

abdominal pains

Mean time : 2.7 days

EF

FIC

IEN

CY

TO

LE

RA

NC

E


international federation for the surgery of obesity and ...international federation for the surgery...

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