OBES SURG (2010) 20:1642–1646 DOI 10.1007/s11695-010-0128-9
CLINICAL REPORT
Efficacy, Safety, and Tolerance of Two Types of Intragastric Balloons Placed in Obese Subjects: A Double-Blind Comparative Study Maria Luisa De Castro & María José Morales & Víctor Del Campo & Juan R. Pineda & Eduardo Pena & José M. Sierra & María José Arbones & Ignacio R. Prada
Published online: 15 April 2010 # Springer Science+Business Media, LLC 2010
Abstract The intragastric balloon is a temporary treatment for obese patients. Fluid-filled devices have shown efficacy and safety, and are widely used. Recently, although there are no comparative studies between them, an air-filled balloon, Heliosphere® bag, has been proposed. Prospective, double-blind study in 33 patients with morbid and type 2 obesity: 23 female, 43.9±10 years, 120.3±17 kg, and body mass index (BMI) of 44.2±5 kg/m2, placing 18 gastric balloons filled with 960 cm3 of air (Heliosphere® bag) or 15 balloons filled with 700 ml of saline (BioentericsBIB®). Both balloons were placed with conscious sedation and removed under general anesthesia 6 months later. Intravenous drugs were given to control symptoms for 48 h. Patients were sent home on a 1000-kcal diet, multivitamin supplements, and oral proton pump inhibitors, and were followed monthly. Complications, symptoms, weight, and quality of life evaluated by the Gastrointestinal Quality 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/m2) and percent excess weight loss (27± 16 vs.30.2±17) showed no significant differences between M. L. De Castro (*) : J. R. Pineda : I. R. Prada Department of Gastroenterology, Universitary Hospital of Vigo (CHUVI), Vigo, Galicia, Spain e-mail:
[email protected] M. J. Morales : E. Pena : J. M. Sierra : M. J. Arbones Department of Endocrinology, Universitary Hospital of Vigo (CHUVI), Vigo, Galicia, Spain V. Del Campo Department of Epidemiology, Universitary Hospital of Vigo (CHUVI), Vigo, Galicia, Spain
both groups. At removal, two Heliosphere® bags were not found in the stomach, and four patients required extraction of the balloon by rigid esophagoscopy or surgery (p=0.02). Tolerance was good in both groups, but early removal occurred in three BIB® (20%) due to vomits and dehydration. The GIQLI total scores remained unchanged. Both balloons achieve a significant weight loss with good tolerance in obese patients. Nevertheless, Heliosphere® bag has severe technical problems that need to be solved before recommending it. Keywords Obesity . Intragastric balloon . Body mass index . Endoscopy . Weight loss . Safety . Efficacy
Introduction Obesity is a chronic disease with considerable morbidity and mortality. Numerous diseases are caused or worsened by obesity, shortening life expectancy and affecting quality of life and increasing health care costs [1, 2]. The first treatment approach should consist of a combination of a calorie-restricted diet, physical activity, and behavioural modifications. For patients who fail to achieve an adequate weight loss, pharmacotherapy is also recommended, while a surgical approach is restricted to the extremely obese [3]. However, there is an intermediate group of patients who do not respond to medical therapy and who are not presently, or in the future, surgical candidates. The intragastric balloon appears attractive for this group of patients, as it is considered to be a temporary and reversible method of facilitating the implementation of new dietary and behavioural habits.
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In the early 1980s, several intragastric air-filled pouches with filling volumes of 20–500 ml were proposed. After an initial enraptured period, a critical phase followed due to the failure and/or high complication rate of the Garren–Edwards, Ballobes, Taylor and Wilson–Cook balloons [4–8]. In recent years, a silicone saline-filled balloon, the BioEnterics intragastric balloon (BIB®), was introduced. This device follows the proposed criteria for ideal intragastric balloons [9], and a very low complication rate and satisfactory weight losses have been reported [10–14]. Nevertheless, fluid-filled balloons are frequently associated with digestive intolerance, probably related to the great weight of these devices, which can oblige early removal. Recently, a new air-filled intragastric balloon, the Heliosphere® bag, has been proposed for obesity treatment. It is made of an internal polyurethane envelope and an external silicone pouch and weights only 30 g. Although it seems to achieve good results concerning weight loss, some worries data about their safety have been reported in three case series [15–17]. Our aim was to evaluate the efficacy, safety, and tolerance of this new device compared to the saline-filled BIB® balloon.
Patients and Methods Design We performed a prospective, double-blind study placing saline-filled Bioenterics BIB® and air-filled Heliosphere® bag gastric balloons. Each patient was randomly assigned to one group, and the type of the implanted devices was blinded to the patients and their controlling endocrinologist throughout the study. Inclusion criteria were morbid obesity [body mass index (BMI)>40] in preparation for a bariatric operation to reduce surgical risk or where they were not candidates for bariatric surgery, BMI 35–40 with obesity-related diseases that ruled out bariatric surgery and BMI 35–40 in patients who had failed many attempts at weight loss. Exclusion criteria were presence of an organic disease of the upper digestive tract, a hiatus hernia of diameter >3 cm, and patients on anti-inflammatory agents or anticoagulants. Included patients had routine blood tests, electrocardiogram, chest X-ray, and a dietetic evaluation including nutritional education. Specifically written informed consent was signed by all participants, and the study was approved by the Clinical research Ethics Committee of Galicia, Spain. Procedures After diagnostic endoscopy, balloon positioning was performed under conscious sedation in our endoscopy unit.
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After lubrication of their protective sheaths, the balloons were passed and located beneath the inferior oesophageal sphincter. Then, the injection catheter was connected to a 60-cm3 syringe, and the balloons were slowly inflated with 960 cm3 of air (which gives a final inflation volume of 700 cm3) or filled with 700 cm3 of saline plus 10 cm3 of methylene-blue dye. Once released, the balloons’ correct location was checked by endoscopy. Insertion and retrieval times, drugs, and complications were recorded. During the first 48 h after insertion, intravenous saline (30–35 ml kg−1 day−1), pantoprazole (40 mg/day), metoclopramide (30 mg/day), and butylscopolamine bromide (20 mg t.i.d.) were administered. The initial diet was liquid, with a gradual return to solid food. All patients were discharged from hospital and sent home on a 1000-kcal diet, oral multivitamin supplements, and proton pump inhibitors (PPIs). Follow-up involved a monthly checkup with routine blood tests (including metabolic parameters), weight control, and waist circumference. At these interviews patients were asked for digestive symptoms such as vomiting and epigastric pain. Gastroesophageal reflux symptoms were recorded at 0, 1, 3, and 6 months by the Gastroesophageal Reflux Disease Impact Scale (GIS) [18]. Quality of life was measured by the Gastrointestinal Quality of Life Index (GIQLI) scale before placement of the balloons and just before their retrieval [19]. After 6 months, the balloons were removed on an outpatient basis under general anaesthesia and tracheal intubation. We used the extraction kit provided by the manufacturers for each type of balloon, which consists of an emptying catheter to puncture and deflate the devices, and a hook forceps to grasp and remove them gently. After balloon removal, patients were followed twice monthly for up to 12 months by their endocrinologist, recording their body weight measures at 6 and 12 months. Statistical Analysis As we usually place one or two balloons in obese subjects every month, our aim was to perform a pilot study between two groups of 20 patients each in order to compare these two devices. Therefore, assuming a 10% loss at follow-up, the total number of patients to include should be 44. These results could be included in the future in a more extensive study. Data are expressed as mean±standard deviation or percentages and ranges (in brackets). In order to analyze the continuous variables, the Mann–Whitney U and Wilcoxon non-parametric tests were applied, while the categorical variables were evaluated using the Fisher exact test. Statistical significance was considered with p0,005) in both groups: from 119.7 [11] to 111.8 cm [12] in Heliosphere® bag and from 120.5 [15] to 111 cm [15] for BIB® balloon. Twelve months after withdrawal, 26 subjects were re-evaluated, one was lost and three had undergone bariatric surgery in this period of time. The mean weights were 116±19 kg for Heliosphere® bag and 108±13 kg for BIB®, with no differences with respect to their baseline weight: p=0.47 and p=0.07, respectively (Fig. 1). Table 1 Baseline characteristics of the patients
There were no significant differences between both groups.
Twenty-seven patients answered the GIQLI quality of life questionnaire, and baseline total scores were similar in both groups with no significant differences at week 24 after balloon insertion: Heliosphere® bag score increased from 92.2±18 to 102.4±23 and Bioenterics BIB® decreased from 86.9±17 to 83.6±12. A significant improvement of the score was observed for the physical dimension in Heliosphere® bag 1.5±0.6 to 2.5±0.7 vs. 1.2±0.6 to 1.5± 0.9 (p=0.03), but not for digestive symptoms, effect of treatment and social or emotional dimensions of GIQLI (Table 2). Safety Endoscopic times were shorter for Heliosphere® bag at placement and balloon retrieval: 7.8±2 vs 12.5±3 min (p=0.001). Nevertheless, balloon insertion under conscious sedation was impossible in two Heliosphere® bag patients due to rigidity of the device at the pharynx causing severe patient discomfort, so they had to be placed under general anaesthesia. System failure at positioning was observed in one BIB® due to the impossibility of injecting the saline through the catheter. Thus, a new balloon was placed during the same operation. At the time of removal, two Heliosphere® bags were not found in the stomach, and as abdominal X-rays and CT scan were negative, we concluded that they had passed in the stool. Balloon removal was more difficult in the Heliosphere® bag group: one patient required surgical removal of the balloon by laparoscopy, and in other three patients, a rigid esophagoscopy was required following attempted endoscopic extraction. In all these patients, the deflated balloons failed to be pulled out through the cardia, as the hook forceps tore the external pouch of the balloon in every attempt. Even though we tried to relax the cardia by injecting glucagon and butylscopolamine bromide intravenously and to grasp the empty devices using a snare, only three balloons could partially go through the cardia. These devices could eventually be removed using a rigid endoscope with a big forceps. Nevertheless, one balloon could not even reach the distal esophagus, so 48 h later, this patient was operated on performing a laparoscopic Heliosphere® bag, n=18
Mean age (years) Percent female Mean weight (kg) Mean BMI (kg/m2) BMI>40 patients GIS total score GICLI total score
42.7 13 119 44.2 13 32.8 92.2
(±12) (72.2%) (±17) (±5) (72.2%) (±3) (±18)
BIB® balloon, n=15 45.4 10 121 44.2 12 29.4 86.9
(±8) (66.7%) (±17) (±6) (80%) (±7) (±17)
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or vomits revealed no differences. Gastroesophageal reflux scores were measured by GIS scale in 27 patients, showing neither differences between groups nor significant changes with respect to baseline scores and 1, 3, and 6-month postballoon scores (data not shown).
Discussion
Fig. 1 Evolution of body weight after balloon placement. At 6 months, body weight was decreased significantly respect to baseline (p
