Original article
Outcomes of intragastric balloon placements in a private practice setting
Authors
Elisabeth M. H. Mathus-Vliegen1, Peter R. H. Alders2, Ram Chuttani3, Joost Scherpenisse4
Institutions
Institutions are listed at the end of article.
submitted 12. March 2014 accepted after revision 22. September 2014
Background and study aim: Intragastric balloons are used as a treatment for obesity. Much of the data collected on balloons has been in the context of clinical trials in academic medical centers or as a bridge to bariatric surgery in obesity centers. The aim of this study was to investigate the efficacy and safety of balloon treatment in private practice. Patients and methods: This was a retrospective analysis of 6-month weight loss data and balloonrelated complications of patients referred to three private centers for obesity treatment. Results: A total of 815 patients (131 males) were referred for balloon treatment (mean age 36.5 years, mean body weight 111.7 kg, mean body mass index [BMI] 38.1 kg/m2). The 6-month weight loss data were available for 672 patients. Mean weight loss was 20.9 kg (7.2 BMI units). A total of 372 patients visited the center only once following balloon placement (i. e. for balloon re-
moval), but these patients still achieved a mean weight loss of 19.4 kg (6.6 BMI units). Successful weight loss (i. e. ≥ 10 %) was achieved in 85.0 %. Severe complications consisted of dehydration requiring hospital admission (n = 2; 0.2 %), and intestinal obstruction caused by balloon deflation, which required surgery (n = 2; 0.2 %). A total of 35 deflated balloons (4.3 %) were passed rectally without any adverse events. Severe esophagitis following balloon placement was diagnosed in 12 patients (1.5 %). A total of 53 patients (6.5 %) requested balloon removal during the first month. Nine balloons (1.1 %) were removed for medical reasons. Conclusion: In the private practice setting, intragastric balloons on their own, without an intensive lifestyle program and supportive consultations, resulted in safe and substantial weight losses, and may fill the therapeutic gap between pharmacotherapy and surgery.
Introduction
Evidence-based guidelines for treating obesity do not include endoscopic procedures, partly because some of these techniques were not available at the time of the review (e. g. the duodenojejunal bypass liner [4]). In the case of intragastric balloons, writers of the guidelines reviewed the available systematic Cochrane review on intragastric balloons, which included only studies involving previously used, and now abandoned, hazardous balloons [5]. Three recent reviews of the most current intragastric balloons concluded that they were effective in promoting short-term weight loss in two-thirds of patients, with significant improvements in co-morbidities [6 – 8]. The treatment was safe provided that the balloon was removed after 6 months and that patients with contraindications were not treated. There has been a rapid expansion of intragastric balloons, with different fill volumes and fill media (air, fluid, combination of air and fluid), and balloons that can be adjusted [9, 10]. Balloons that
Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1390860 Published online: 5.12.2014 Endoscopy 2015; 47: 302–307 © Georg Thieme Verlag KG Stuttgart · New York ISSN 0013-726X Corresponding author Elisabeth M. H. MathusVliegen, MD, PhD Department of Gastroenterology and Hepatology Academic Medical Centre University of Amsterdam Meibergdreef 9 1105 AZ Amsterdam The Netherlands Fax: +31-20-6907133 [email protected]
!
Obesity is a growing worldwide epidemic and is associated with a number of serious medical conditions. According to several guidelines, treatment should focus on a sustained 5 % – 15 % weight loss to either prevent or reduce the risk of developing cardiovascular and other obesityrelated diseases [1, 2]. Treatment algorithms are typically staged, with the first step consisting of intensive lifestyle intervention including an energy-restricted diet, physical exercise, and behavior modification. The second step consists of drug treatment, and the final step involves surgery. For motivated patients who have seriously attempted but failed to achieve weight loss by intensive lifestyle modification, pharmacotherapy is recommended. Unfortunately, many drugs have been withdrawn from the market and only a few moderately effective drugs remain [3].
Mathus-Vliegen Elisabeth MH et al. Intragastric balloons in a private practice setting … Endoscopy 2015; 47: 302–307
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
302
can be swallowed are also available and these do not require an endoscopy for placement [11, 12]. Most of the investigations on intragastric balloons have studied their use as a bridge to surgery, in order to improve laparoscopic access by reducing the size of the liver, to reduce postoperative complications, and to improve postoperative outcomes [13 – 15]. In addition, the balloon has been used to predict the outcome of restrictive surgery [16 – 18]. However, the use of intragastric balloons in nonmorbidly obese patients, who are not yet candidates for surgery, has not been studied extensively. Moreover, virtually no reports have been published on patients who are treated exclusively outside the academic or hospital settings, and outside the setting of a clinical trial. The challenge of balloon placement performed in an everyday practice by gastroenterologists or surgeons with less experience than their academic colleagues or bariatric surgeons, is to realise a similar degree of efficacy and safety as has been published in the academic literature. The aim of this study was to examine whether this level of efficacy and safety could be obtained in a private practice setting, where compliance with dietary advice, physical exercise, behavioral modification, and frequency of follow-up were left to the wishes of the patient.
Patients and methods !
A large outpatient center in Rotterdam and two smaller outpatient centers in Amsterdam and Beverwijk were contacted for data. Anonymous data were entered into a database following completion of a predefined questionnaire, which included demographic data of the patients, data on balloon positioning, complications during balloon presence and at balloon removal, weight loss at 3 and 6 months after balloon placement, and follow-up data 9 months after balloon placement. The Medical Ethical Committee of the Academic Medical Centre (University of Amsterdam) waived the need for approval because data were anonymous. The primary end points were efficacy (weight loss after 6 months of therapy) and safety (frequency of complications). Complications were divided into major (requiring hospitalization, blood transfusion or surgery) and minor events. Secondary end points included weight loss after 3 and 9 months, the proportion of patients achieving successful weight loss after 6 months (see below), and endoscopic findings at balloon removal. Before starting intragastric balloon therapy, patients were seen in the outpatient clinic to assess their eligibility for the procedure. Patients signed an informed consent form, which emphasized the importance of returning after 6 months to have the balloon removed. Criteria for eligibility consisted of willingness to follow the diet and exercise instructions, and a body mass index (BMI) of at least 30 kg/m2. Exclusion criteria were pregnancy or breastfeeding, alcoholism or drug abuse, and psychiatric illnesses. Contraindications that were specifically related to balloon placement included gastrointestinal lesions (e. g. hiatal hernia > 3 cm, severe esophagitis, esophageal or gastric varices), and previous bariatric or abdominal surgery. The use of anticoagulants, aspirin, and nonsteroidal anti-inflammatory drugs was prohibited. Each patient underwent an endoscopy under conscious sedation with midazolam to exclude gastrointestinal contraindications and to measure the distance between the incisor teeth and the gastroesophageal junction. After removal of the endoscope, the balloon placement assembly (BioEnterics Intragastric Balloon; Allergan, Irvine, California, USA), consisting of a sheath containing the collapsed balloon and a balloon fill tube, was in-
Fig. 1 The BioEnterics Intragastric Balloon placement assembly (Allergan, Irvine, California, USA), consisting of a sheath with the collapsed balloon and a balloon fill tube. The balloon is filled with 500 mL of saline, and inside the balloon the self-sealing and re-penetrable valve with a Z-shape configuration is visible. The catheter for re-intubation of the valve for balloon adjustment or balloon removal is shown below the placement assembly.
" Fig. 1). serted 10 cm distal to the gastroesophageal junction (● The balloon was filled with 500 mL saline and 2.5 mL methylene blue, which in the event of balloon leakage would alert the patient by coloring the urine green. The fill catheter was then removed from the valve with a quick pull. (The valve is radiopaque and therefore visible on a plain abdominal radiograph, should the need arise.) Butylscopolamine and metoclopramide were prescribed as 10 – 20-mg suppositories to treat cramps, nausea, and vomiting following balloon positioning. A proton pump inhibitor (40 mg) was prescribed to reduce the risk of esophagitis and gastric ulcers, and ursodeoxycholic acid (500 mg) was prescribed to reduce the risk of gallstone formation caused by rapid weight loss. After balloon positioning, patients were given dietary advice and recommendations for physical exercise, and were offered supportive consultations with weight measurements. After 6 months the balloon was removed and the weight loss was calculated.
Statistics Descriptive data are given as means (± SD) and ranges or as proportions. Weight loss data were analyzed on a per-protocol base. To calculate the excess weight, the ideal body weight was taken from the Metropolitan Life Insurance Tables for mid-frame subjects and subtracted from the actual body weight; percentage excess weight loss (% EWL) was calculated by dividing the weight loss by the excess weight. Patients were stratified by successful weight loss (≥ 10 % total body weight loss, a definition used by internists; and ≥ 50 % EWL, a definition used by surgeons). For comparison of groups, the student’s t test was used for normally distributed data and the Mann–Whitney U test was used for nonnormal data. Proportional data were compared using the chisquared test. A two-sided P value of < 0.05 was considered to represent a significant difference. Predictors of successful outcome (≥ 10 % total body weight loss) were investigated by univariate analysis, and variables with a P < 0.1 difference were entered into a logistic regression analysis. The Statistical Package for Social Sciences (SPSS) version 21.0 was used (IBM Corp., Armonk, New York, USA).
Mathus-Vliegen Elisabeth MH et al. Intragastric balloons in a private practice setting … Endoscopy 2015; 47: 302–307
303
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Original article
Original article
Table 1
Baseline patient characteristics.
Patients, mean ± SD (range) (n = 815) 36.5 ± 9.8 (12 – 71)
Age, years Body weight, kg
111.7 ± 22.7 (68.3 – 235.0)
BMI, kg/m 2
38.1 ± 6.4 (26.9 – 67.9)
Excess weight, kg
47.2 ± 20.0 (12.9 – 158.9)
Excess weight, %
40.6 ± 9.0 (15.9 – 67.6)
Duration of obesity (n = 53), years
16.9 ± 9.4 (2 – 38) 9.2 ± 4.3 (3 – 16)
Total number of diets (n = 17) Lifestyle factors, n (%) (n = 815) Smoking No smoking
554 (68.0)
1 – 10 cigarettes
64 (7.9)
10 – 20 cigarettes
81 (9.9)
≥ 20 cigarettes
97 (11.9)
Unknown
19 (2.3)
Alcohol No alcohol
565 (69.3)
1 – 3 units
212 (26.0)
3 – 6 units
14 (1.7)
6 – 9 units
1 (0.1)
≥ 9 units
1 (0.1)
Unknown
22 (2.7)
Co-morbidity, n (%) (n = 796) Type 2 diabetes mellitus
poned balloon removal to 9 months. Another 33 patients did not want to be weighed at the center. Therefore, 6-month weight loss data were available for 672 patients. The mean weight loss at 6 months was 20.9 ± 10.3 kg (range – 64.2 to + 1.7) corresponding to a mean body weight of 91.2 ± 20.7 kg. BMI decreased by 7.2 BMI units to a BMI of 31.2 ± 6.3 kg/m2 (range 19.8 – 63.6). Following balloon placement, 372 patients were only seen at 6 months for balloon removal. These patients, despite not receiving any dietary support or counselling, achieved a weight loss of 19.4 kg (6.6 BMI units). A total of 326 patients attended for weight consultation at 3 months and had lost 15.8 ± 6.5 kg (range – 47.4 to + 2.2), corresponding to a mean body weight of 99.2 ± 27.0 kg. BMI had decreased by 5.41 BMI units to a BMI of 33.8 ± 6.5 kg/m2 (range 20.0 – 59.0). Notably, in 65 patients, although the BMI increased 3 months after balloon removal to 34.1 ± 8.0 kg/m2, it remained 6.6 BMI units (18.8 kg) lower than the baseline level. Successful weight loss after 6 months as defined by internists (≥ 10 % total body weight loss) was achieved by 571 patients (85.0 %). Two patients lost as much as 40 % of their body weight " Fig. 3). Successful weight loss as defined by surgeons (≥ 50 % (● EWL) was achieved by 299 patients (44.5 %); 12 patients lost more than 100 % of their excess weight.
18 (2.3)
Medication for diabetes
18 (2.3)
Safety of balloon treatment
Cardiovascular disease
37 (4.6)
Balloons remained in place for a mean of 180.4 ± 61.6 days (range 1 – 390). In the first week, 36 patients (4.4 %) requested balloon removal for a variety of reasons, including physical discomfort, psychological intolerance, and geographical relocation. An additional 17 patients (2.1 %) requested to have the balloon removed within the first month. Complications consisted of two premature balloon removals because of dehydration and electrolyte disturbances, which required hospital admission (0.2 %). A total of 35 balloons (4.3 %) deflated prematurely and were passed rectally without any adverse events. However, two further balloons deflated and were not seen in the stomach at the 6-month endoscopy. A wait-and-see policy was followed for these patients, but intestinal obstruction " Table 2). Minor comensued, and surgery was required (0.2 %) (● plications that required balloon removal included one case of esophageal obstruction by impacted food in the presence of abnormal esophageal peristalsis and a balloon located high in the fundus, and five cases of hematemesis (not requiring hospital admission), among which one Mallory–Weiss tear was found at endoscopy. One woman became pregnant during therapy and the balloon was removed. Two transient gastric bleeds occurred during balloon removal when the grasper caught a mucosal fold of the stomach. Endoscopic records were available for 813 patients. In the other two patients, the endoscopic view was obscured by the transient bleed caused by the grasper. Inspection of the stomach revealed " Table 2). Severe esophagiabnormalities in 69 patients (8.5 %) (● tis was present in 12 patients (1.5 %), but this has not induced symptoms that required premature balloon removal.
Medication for cardiovascular disease Hypertension
8 (1.0) 124 (15.6)
Medication for hypertension
70 (8.8)
Osteoarthritis
71 (8.9)
Gallstones
40 (5.0)
Blood pressure, mmHg (n = 55) Systolic blood pressure
138 ± 18.0 (105 – 190)
Diastolic blood pressure
91 ± 12.5 (70 – 135)
Laboratory values, mean ± SD (range) (n = 35) Total cholesterol (< 5 mmol/L 1)
5.59 ± 1.17 (3.1 – 8.2)
LDL cholesterol (< 3 mmol/L 1)
3.50 ± 1.21 (0.9 – 5.8)
HDL cholesterol (1.1 – 2.0 mmol/L 1)
1.08 ± 0.32 (0.6 – 1.7)
Triglycerides (0.6 – 2.2 mmol/L 1)
2.30 ± 1.24 (0.6 – 6.5)
Fasting glucose (4.0 – 6.0 mmol/L 1)
5.19 ± 1.7 (4.0 – 11.9)
BMI, body mass index; LDL, low-density lipoprotein; HDL, high-density lipoprotein. 1 Normal healthy range.
Results !
A total of 815 patients were included (131 males [16.1 %], mean age 36.5 years, mean body weight 111.7 kg, mean BMI " Table 1). Seven patients were younger than 18 38.1 kg/m2) (● years and five were older than 60 years. A total of 30 patients had a BMI value between 26 and 30, and 213 had a BMI ≥ 40 kg/m2. Almost 70 % of patients did not use alcohol or tobacco. The presence or absence of co-morbidities (mainly hypertension and osteoarthritis) was known for the majority of patients (97.8 %). Blood pressure and laboratory values were known for only a few " Fig. 2 shows the flow chart of patients available for patients. ● the analysis of efficacy and safety.
Predictors of a successful outcome Efficacy of balloon treatment A total of 62 balloons were removed prematurely in the first months for personal or medical reasons. In 10 patients, the balloons were prematurely removed just before the end of the 6month period for logistical reasons. A total of 30 patients had their weights measured only at 3 months. Eight patients post-
Sex, age, baseline BMI and body weight, the presence of co-morbidities, and lifestyle habits may determine the extent of body weight loss. A successful weight loss of ≥ 10 % initial weight was achieved by 571 patients. In the 101 unsuccessful patients, diabetes was present in three times as many patients and osteoarthritis was present in double the number of patients compared
Mathus-Vliegen Elisabeth MH et al. Intragastric balloons in a private practice setting … Endoscopy 2015; 47: 302–307
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
304
Original article
Fig. 2
Balloon placement in eligible patients (N = 815)
305
Flow-chart of patients through the study.
Primary outcome
Weight loss data at 6 months (n = 672), of whom 372 only visited the center at balloon placement and removal
Safety data at balloon removal (n = 815)
Secondary outcome
Weight loss data at 3 months (n = 326)
Endoscopy data at removal (n = 813) ▪ 2 removal-associated bleedings with a limited endoscopy report
Weight loss data at 9 months (n = 65)
Fig. 3 Weight loss stratified by percentage total body weight loss and percentage excess weight loss.
50 % weight loss
Patients (%)
40
% excess weight loss
30
20
10
0 0–10 20–30 40–50 10–20 30–40
Table 2
0–10 20–30 40–50 60–70 80–90 >100 10–20 30–40 50–60 70–80 90–100
Complications of intragastric balloon therapy.
n (%) Balloon-related complications (n = 815)
48 (5.9)
Major
4 (0.5)
Dehydration, electrolyte disturbances
2 (0.2)
Balloon deflation, intestinal obstruction, and surgical intervention
2 (0.2)
Minor
1 (0.1)
Pregnancy requiring balloon removal
1 (0.1)
Gastric hemorrhage with hematemesis requiring balloon removal
5 (0.6)
Balloon deflation with uneventful rectal evacuation
35 (4.3)
Gastric hemorrhage during balloon removal
Discussion !
44 (5.4)
Esophageal food obstruction requiring balloon removal
Findings at endoscopy (n = 813)
" Table 3). Logistic regreswith the successful weight loss group (● sion analysis could not be performed, however, as all statistical conditions (normal distribution of data and absence of autocorrelation and collinearity) were not fulfilled.
2 (0.2) 69 (8.5)
Esophagitis grade I
19 (2.3)
Esophagitis grade II
31 (3.8)
Esophagitis grade III
12 (1.5)
Gastric erosions
7 (0.9)
To our knowledge, this is the first study to examine the efficacy and safety of intragastric balloon treatment outside the academic medical or bariatric surgery center environment and outside a clinical trial. The study showed that patients lost a mean of 15.8 kg and 20.9 kg after 3 and 6 months of balloon therapy, respectively, suggesting that over 75 % of the weight loss during balloon therapy occurs during the first 3 months. Importantly, patients who were not seen between the time of balloon placement and removal, lost 19.4 kg of weight, suggesting that nutritional follow-up during balloon therapy may not be as critical to success as previously thought. This study confirmed the finding reported in the literature that patients with diabetes have more difficulty in losing
Mathus-Vliegen Elisabeth MH et al. Intragastric balloons in a private practice setting … Endoscopy 2015; 47: 302–307
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Reason for having no weight loss measurements at 6 months ▪ Balloon removal at own request (n = 53) in first month ▪ Balloon removal for medical reasons (n = 9) within 2 months ▪ Balloon removal for logistical reason (n = 10) before 6 months ▪ Weight measured only at 3 months (n = 30) ▪ Weight measured only after 9 months (n = 8) ▪ Refused to be weighed at the center (n = 33)
Original article
Patients, n Age, years
Unsuccessful weight loss
Successful weight loss
< 10 % initial body weight
≥ 10 % initial body weight
101
571
37.2 ± 9.6
P value
35.3 ± 9.6
0.180
Sex, n Male Female Baseline body weight, kg
0.435 18 83
487 84
105.7 ± 17.9
110.5 ± 20.2
Baseline BMI, kg/m 2
36.4 ± 6.0
38.0 ± 5.8
0.058
Body weight at 6 months, kg
98.8 ± 16.6
88.2 ± 32.4
0.017
BMI at 6 months, kg/m 2
34.0 ± 5.5
30.4 ± 13.0
0.042
6.9 ± 3.3
23.6 ± 9.4
< 0.001
Weight loss, kg Weight loss, %
0.090
6.5 ± 2.9
21.3 ± 7.1
< 0.001
Balloon in place, days
196.1 ± 38.4
196.3 ± 37.5
0.971
Co-morbidity, n (%)
101
557
Diabetes Hypertension Cardiovascular disease Osteoarthritis Lifestyle habits, n (%)
Table 3 Predictors of successful weight loss.
6 (5.9)
10 (1.8)
0.015
10 (9.9)
95 (17.1)
0.072
8 (7.9)
23 (4.1)
0.099
17 (16.8)
40 (7.2)
0.002
101
571
Smoking
25 (24.8)
190 (33.3)
0.089
Alcohol intake
35 (34.7)
171 (30.0)
0.347
BMI, body mass index.
weight. Patients with osteoarthritis also found it harder to lose weight, possibly because of their reduced ability to adequately follow the physical exercise advice. It is reassuring that sex, age, baseline BMI and body weight, and lifestyle habits did not influence the extent of weight loss. A previous study attempted to isolate the effects of balloons on weight loss outcomes. In the 1980 s, Borody conducted a doubleblind, randomized trial in 20 patients who received either a Ballobes balloon (DOT ApS; Rödovre, Denmark) filled with 500 mL of air for 16 weeks, or a sham insertion procedure following an endoscopy [19]. In order to exclude the benefits of dietary and behavioral follow-up, none of the patients received supportive consultations. All 20 patients returned to the clinic for balloon removal after 16 weeks. There was a weight loss of 10.6 % (range 2.4 % – 23.1 %) in the balloon group and 0.6 % in the sham group (P < 0.02). Two randomized, double-blind, placebo-controlled trials have been performed by our group [20, 21]. In the first trial, which used the Ballobes balloon, there was no difference between the four treatment groups (2 × 4-month treatment of balloon – sham, balloon – balloon, sham – balloon, or sham – sham) [20]. All four groups lost 50 kg in 8 months, but this might have been due to the very intensive guidance and lifestyle program that accompanied balloon treatment. In the second study, which used the BioEnterics Intragastric Balloon, there was no difference between the first 13 weeks of balloon treatment and the sham treatment [21]. Genco et al. demonstrated a clear benefit of balloon treatment in a crossover design [22], whereas Martinez-Brocca et al. found no differences between balloon and sham treatment in a parallel design [23]. In all of these studies, however, patients in both groups were followed weekly or biweekly, and all received intensive additional lifestyle support. The current report is the first study in which a substantial number of patients who did not receive dietary and nutrition follow-up achieved a weight loss comparable with those who did. In The Netherlands, only bariatric surgery is reimbursed by health insurance companies. Intensive lifestyle intervention,
pharmacotherapy, and intragastric balloon treatment must be paid for by the patients themselves. Specialist outpatient clinics offer these kinds of treatments. One explanation for the beneficial results may be that outside a clinical trial, patients are paying for intragastric balloon therapy and may feel a financial motivation – and also social pressure – to achieve the best results possible. Most importantly, this study demonstrates that balloons can be used safely in private practice, especially when patients are strongly advised to return after 6 months to have the balloon removed and when patients with previous abdominal surgery are excluded. Balloons remaining in the stomach for longer than the prescribed 6 months or patients who have undergone previous abdominal surgery have been shown to be at higher risk of complications [6]. In the current study, eight patients postponed balloon removal for up to 9 months without adverse events. Follow-up data on the safety of balloons was obtained for all 815 patients. Both major (0.5 %) and minor (5.4 %) complications were surprisingly infrequent given that these balloons were administered in private practice with less frequent follow-up than in an academic medical center environment or at bariatric surgery centers. Interestingly, however, even though patients were paying for their balloons, the incidence of early removals (7.6 %; 62/815) was double the figure reported in a recent meta-analysis (4.2 %) [8]. Moreover, the rate at which patients voluntarily requested balloon removal was 6.5 % in the current study, compared with only 1.8 % in previous series [8]. This suggests, that patients may not have been well informed about the initial side effects of balloon therapy and the need for adequate medication to overcome symptoms. This result highlights the need to clearly prepare patients for these early side effects. The deflation rate of 4.5 % is the same as that reported in a recent meta-analysis [8]. The collective frequency of relevant gastrointestinal complications, such as gastric hemorrhage, esophageal obstruction, and esophagitis grade II and III (6.0 %; 49/815) is similar to the rate reported in the litera-
Mathus-Vliegen Elisabeth MH et al. Intragastric balloons in a private practice setting … Endoscopy 2015; 47: 302–307
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
306
ture (5.2 %) [8]. Esophagitis was not a reason for premature balloon removal and was often an unexpected finding. Although this study has many strengths, such as complete safety follow-up for the entire cohort, it also has several limitations. No information was available about the characteristics of the patients who were able to pay, and therefore motivated to undergo, this treatment. The design was retrospective, and therefore some data were easy to retrieve, but important obesity-related variables (e. g. family history, age of menarche, age of onset of obesity, previous weight loss attempts, and weight losses achieved) were lacking. Also, data on the improvement of co-morbid conditions could not be retrieved as the clinics had no access to laboratory facilities. Finally, as the patients were not followed as closely as in previous trials, some complications may have gone unreported. Interestingly, despite being in a private practice setting, 65 patients returned for follow-up 3 months after balloon removal. They had regained 15 % of the weight lost but were still 6.6 BMI units (18.8 kg) below their baseline body weights. This is a particularly valuable result, as this information “in the free-living condition” is not usually available. A previous meta-analysis showed that 1 year after balloon removal, 6.3 kg of the 15.9 kg lost at balloon removal was regained in 133 patients [8, 21, 24]. In 100 patients studied by Negrin Dastis et al., 63 % attained a 10 % weight loss at balloon removal and 24 % of patients maintained their 10 % weight loss after 2.5 years [25]. Kotzampassi et al. demonstrated that of the 393 successful patients (success defined as a ≥ 20 % EWL after 6 months of balloon treatment), 53 %, 27 %, and 23 % maintained a ≥ 20 % EWL after 12, 24, and 60 months, respectively [26]. It will be important to collect similar long-term follow-up data on weight regain in private practice. In conclusion, intragastric balloon therapy may fill the gap in a therapeutic vacuum between weight loss drugs and surgery [27, 28]. Even in private practice, patients were able to lose clinically meaningful amounts of weight. Moreover, this weight loss can be achieved with minimal complications. As balloon use in private practice grows, it will be critical to ensure that patients return after 6 months to have the balloon removed, as patients lost to follow-up are more likely to experience balloon deflation and intestinal obstructions. Future studies will assess the costs and benefits of intragastric balloon therapies compared with intensive lifestyle intervention with or without pharmacotherapy. Competing interests: Dr. Chuttani holds an equity position with Allurion Technologies. Institutions 1 Department of Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands 2 General Practice, Wieringerwerf, The Netherlands 3 Beth Israel Deaconess Medical Center and Harvard School, Boston, Massachusetts, United States 4 Gelre Hospital, Apeldoorn, The Netherlands
References 1 World Health Organization. Obesity: preventing and managing the global epidemic. Report of a WHO Consultation on Obesity, Geneva, 3–5 June 1997. Report No.: WHO/NUT/NCD/98.1 Geneva: WHO; 1998 2 National Institutes of Health and National Heart. Lung and Blood Institute. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults – the evidence report. Obes Res 1998; 6: 1S – 209S 3 Isidro L, Cordido F. Approved and off-label use of obesity medications, and potential new pharmacologic treatment options. Pharmaceuticals 2010; 3: 125 – 145
4 de Moura EG, Orso IR, Martins BC et al. Improvement of insulin resistance and reduction of cardiovascular risk among obese patients with type 2 diabetes with the duodenojejunal bypass liner. Obes Surg 2011; 21: 941 – 947 5 Fernandes M, Atallah AN, Soares BG et al. Intragastric balloon for obesity. Cochrane Database Syst Rev 2007; 1: CD004931 6 Mathus-Vliegen EM. Intragastric balloon treatment for obesity: what does it really offer? Dig Dis 2008; 26: 40 – 44 7 Dumonceau JM. Evidence-based review of the Bioenterics intragastric balloon for weight loss. Obes Surg 2008; 18: 1611 – 1617 8 Imaz I, Martinez-Cervell C, Garcia-Alvarez EE et al. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. Obes Surg 2008; 18: 841 – 846 9 Espinet-Coll E, Nebreda-Duran J, Gomez-Valero J et al. Current endoscopic techniques in the treatment of obesity. Rev Esp Enferm Dig 2012; 104: 72 – 87 10 Machytka E, Klvana P, Kornbluth A et al. Adjustable intragastric balloons: a 12-month pilot trial in endoscopic weight loss management. Obes Surg 2011; 21: 1499 – 1507 11 Martin CK, Bellanger DE, Rau KK et al. Safety of the Ullorex oral intragastric balloon for the treatment of obesity. J Diabetes Sci Technol 2007; 1: 574 – 581 12 Mion F, Ibrahim M, Marjoux S et al. Swallowable Obalon® gastric balloons as an aid for weight loss: a pilot feasibility study. Obes Surg 2013; 23: 730 – 733 13 Busetto L, Segato G, De Luco M et al. Preoperative weight loss by intragastric balloon in super-obese patients treated with laparoscopic gastric banding: a case-control study. Obes Surg 2004; 14: 671 – 676 14 Marino M, Busetto L, Giardiello C et al. BioEnterics intragastric balloon: the Italian experience with 2,515 patients. Obes Surg 2005; 15: 1161 – 1164 15 Melissas J, Mouzas J, Filis D et al. The intragastric balloon – smoothing the path to bariatric surgery. Obes Surg 2006; 16: 897 – 902 16 Loffredo A, Cappuccio M, De Luca M et al. Three years experience with the new intragastric balloon, and a preoperative test for success with restrictive surgery. Obes Surg 2001; 11: 330 – 333 17 Loffredo A, Cappuccio M, De Luca M et al. BIB test and patient selection in the treatment of morbid obesity. Obes Surg 2001; 10: 326 – 328 18 de Goederen-van der Meij S, Pierik RGJM, Oudkerk Pool M et al. Six months of balloon treatment does not predict the success of gastric banding. Obes Surg 2007; 17: 88 – 94 19 Borody TJ. Double blind study of Ballobes intragastric balloon without diet or behaviour medication. Ballobes symposium Stockholm, Sweden: 04. 06. 1988: Available from: http://www.cdd.com.au/pdf/ publications/All%20Publications/1988-Double%20blind%20study% 20of%20Ballobes%20intragastric%20balloon%20without%20diet%20or %20behaviour%20modification.pdf [Accessed: September 2014] 20 Mathus-Vliegen EM, Tytgat GN, Veldhuyzen-Offermans EA. Intragastric balloon in the treatment of super-morbid obesity. Double-blind, sham-controlled, crossover evaluation of 500-milliliter balloon. Gastroenterology 1990; 99: 362 – 369 21 Mathus-Vliegen EM, Tytgat GN. Intragastric balloon for treatment-resistant obesity: safety, tolerance, and efficacy of 1-year balloon treatment followed by a 1-year balloon-free follow-up. Gastrointest Endosc 2005; 61: 19 – 27 22 Genco A, Cipriano M, Bacci V et al. BioEnterics Intragastric Balloon (BIB): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients. Int J Obes (Lond) 2006; 30: 129 – 133 23 Martinez-Brocca MA, Belda O, Parejo J et al. Intragastric balloon-induced satiety is not mediated by modification in fasting or postprandial plasma ghrelin levels in morbid obesity. Obes Surg 2007; 17: 649 – 657 24 Herve J, Wahlen CH, Schaeken A et al. What becomes of patients one year after the intragastric ballon has been removed? Obes Surg 2005; 15: 864 – 870 25 Negrin Dastis S, Francois E, Deviere J et al. Intragastric balloon for weight loss: results in 100 individuals followed for at least 2.5 years. Endoscopy 2009; 41: 575 – 580 26 Kotzampassi K, Grosomanidis V, Papakostas P et al. 500 intragastric balloons: what happens 5 years thereafter? Obes Surg 2012; 22: 896 – 903 27 Ibrahim M, Blero D, Deviere J. Endoscopic options for the treatment of obesity. Gastroenterology 2010; 138: 2228 – 2232 28 Delegge MH. Endoscopic approaches for the treatment of obesity: fact or fiction? Nutr Clin Pract 2011; 26: 534 – 538
Mathus-Vliegen Elisabeth MH et al. Intragastric balloons in a private practice setting … Endoscopy 2015; 47: 302–307
307
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Original article
Copyright of Endoscopy is the property of Georg Thieme Verlag Stuttgart and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Outcomes of intragastric balloon placements in a private practice setting
Authors
Elisabeth M. H. Mathus-Vliegen1, Peter R. H. Alders2, Ram Chuttani3, Joost Scherpenisse4
Institutions
Institutions are listed at the end of article.
submitted 12. March 2014 accepted after revision 22. September 2014
Background and study aim: Intragastric balloons are used as a treatment for obesity. Much of the data collected on balloons has been in the context of clinical trials in academic medical centers or as a bridge to bariatric surgery in obesity centers. The aim of this study was to investigate the efficacy and safety of balloon treatment in private practice. Patients and methods: This was a retrospective analysis of 6-month weight loss data and balloonrelated complications of patients referred to three private centers for obesity treatment. Results: A total of 815 patients (131 males) were referred for balloon treatment (mean age 36.5 years, mean body weight 111.7 kg, mean body mass index [BMI] 38.1 kg/m2). The 6-month weight loss data were available for 672 patients. Mean weight loss was 20.9 kg (7.2 BMI units). A total of 372 patients visited the center only once following balloon placement (i. e. for balloon re-
moval), but these patients still achieved a mean weight loss of 19.4 kg (6.6 BMI units). Successful weight loss (i. e. ≥ 10 %) was achieved in 85.0 %. Severe complications consisted of dehydration requiring hospital admission (n = 2; 0.2 %), and intestinal obstruction caused by balloon deflation, which required surgery (n = 2; 0.2 %). A total of 35 deflated balloons (4.3 %) were passed rectally without any adverse events. Severe esophagitis following balloon placement was diagnosed in 12 patients (1.5 %). A total of 53 patients (6.5 %) requested balloon removal during the first month. Nine balloons (1.1 %) were removed for medical reasons. Conclusion: In the private practice setting, intragastric balloons on their own, without an intensive lifestyle program and supportive consultations, resulted in safe and substantial weight losses, and may fill the therapeutic gap between pharmacotherapy and surgery.
Introduction
Evidence-based guidelines for treating obesity do not include endoscopic procedures, partly because some of these techniques were not available at the time of the review (e. g. the duodenojejunal bypass liner [4]). In the case of intragastric balloons, writers of the guidelines reviewed the available systematic Cochrane review on intragastric balloons, which included only studies involving previously used, and now abandoned, hazardous balloons [5]. Three recent reviews of the most current intragastric balloons concluded that they were effective in promoting short-term weight loss in two-thirds of patients, with significant improvements in co-morbidities [6 – 8]. The treatment was safe provided that the balloon was removed after 6 months and that patients with contraindications were not treated. There has been a rapid expansion of intragastric balloons, with different fill volumes and fill media (air, fluid, combination of air and fluid), and balloons that can be adjusted [9, 10]. Balloons that
Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1390860 Published online: 5.12.2014 Endoscopy 2015; 47: 302–307 © Georg Thieme Verlag KG Stuttgart · New York ISSN 0013-726X Corresponding author Elisabeth M. H. MathusVliegen, MD, PhD Department of Gastroenterology and Hepatology Academic Medical Centre University of Amsterdam Meibergdreef 9 1105 AZ Amsterdam The Netherlands Fax: +31-20-6907133 [email protected]
!
Obesity is a growing worldwide epidemic and is associated with a number of serious medical conditions. According to several guidelines, treatment should focus on a sustained 5 % – 15 % weight loss to either prevent or reduce the risk of developing cardiovascular and other obesityrelated diseases [1, 2]. Treatment algorithms are typically staged, with the first step consisting of intensive lifestyle intervention including an energy-restricted diet, physical exercise, and behavior modification. The second step consists of drug treatment, and the final step involves surgery. For motivated patients who have seriously attempted but failed to achieve weight loss by intensive lifestyle modification, pharmacotherapy is recommended. Unfortunately, many drugs have been withdrawn from the market and only a few moderately effective drugs remain [3].
Mathus-Vliegen Elisabeth MH et al. Intragastric balloons in a private practice setting … Endoscopy 2015; 47: 302–307
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
302
can be swallowed are also available and these do not require an endoscopy for placement [11, 12]. Most of the investigations on intragastric balloons have studied their use as a bridge to surgery, in order to improve laparoscopic access by reducing the size of the liver, to reduce postoperative complications, and to improve postoperative outcomes [13 – 15]. In addition, the balloon has been used to predict the outcome of restrictive surgery [16 – 18]. However, the use of intragastric balloons in nonmorbidly obese patients, who are not yet candidates for surgery, has not been studied extensively. Moreover, virtually no reports have been published on patients who are treated exclusively outside the academic or hospital settings, and outside the setting of a clinical trial. The challenge of balloon placement performed in an everyday practice by gastroenterologists or surgeons with less experience than their academic colleagues or bariatric surgeons, is to realise a similar degree of efficacy and safety as has been published in the academic literature. The aim of this study was to examine whether this level of efficacy and safety could be obtained in a private practice setting, where compliance with dietary advice, physical exercise, behavioral modification, and frequency of follow-up were left to the wishes of the patient.
Patients and methods !
A large outpatient center in Rotterdam and two smaller outpatient centers in Amsterdam and Beverwijk were contacted for data. Anonymous data were entered into a database following completion of a predefined questionnaire, which included demographic data of the patients, data on balloon positioning, complications during balloon presence and at balloon removal, weight loss at 3 and 6 months after balloon placement, and follow-up data 9 months after balloon placement. The Medical Ethical Committee of the Academic Medical Centre (University of Amsterdam) waived the need for approval because data were anonymous. The primary end points were efficacy (weight loss after 6 months of therapy) and safety (frequency of complications). Complications were divided into major (requiring hospitalization, blood transfusion or surgery) and minor events. Secondary end points included weight loss after 3 and 9 months, the proportion of patients achieving successful weight loss after 6 months (see below), and endoscopic findings at balloon removal. Before starting intragastric balloon therapy, patients were seen in the outpatient clinic to assess their eligibility for the procedure. Patients signed an informed consent form, which emphasized the importance of returning after 6 months to have the balloon removed. Criteria for eligibility consisted of willingness to follow the diet and exercise instructions, and a body mass index (BMI) of at least 30 kg/m2. Exclusion criteria were pregnancy or breastfeeding, alcoholism or drug abuse, and psychiatric illnesses. Contraindications that were specifically related to balloon placement included gastrointestinal lesions (e. g. hiatal hernia > 3 cm, severe esophagitis, esophageal or gastric varices), and previous bariatric or abdominal surgery. The use of anticoagulants, aspirin, and nonsteroidal anti-inflammatory drugs was prohibited. Each patient underwent an endoscopy under conscious sedation with midazolam to exclude gastrointestinal contraindications and to measure the distance between the incisor teeth and the gastroesophageal junction. After removal of the endoscope, the balloon placement assembly (BioEnterics Intragastric Balloon; Allergan, Irvine, California, USA), consisting of a sheath containing the collapsed balloon and a balloon fill tube, was in-
Fig. 1 The BioEnterics Intragastric Balloon placement assembly (Allergan, Irvine, California, USA), consisting of a sheath with the collapsed balloon and a balloon fill tube. The balloon is filled with 500 mL of saline, and inside the balloon the self-sealing and re-penetrable valve with a Z-shape configuration is visible. The catheter for re-intubation of the valve for balloon adjustment or balloon removal is shown below the placement assembly.
" Fig. 1). serted 10 cm distal to the gastroesophageal junction (● The balloon was filled with 500 mL saline and 2.5 mL methylene blue, which in the event of balloon leakage would alert the patient by coloring the urine green. The fill catheter was then removed from the valve with a quick pull. (The valve is radiopaque and therefore visible on a plain abdominal radiograph, should the need arise.) Butylscopolamine and metoclopramide were prescribed as 10 – 20-mg suppositories to treat cramps, nausea, and vomiting following balloon positioning. A proton pump inhibitor (40 mg) was prescribed to reduce the risk of esophagitis and gastric ulcers, and ursodeoxycholic acid (500 mg) was prescribed to reduce the risk of gallstone formation caused by rapid weight loss. After balloon positioning, patients were given dietary advice and recommendations for physical exercise, and were offered supportive consultations with weight measurements. After 6 months the balloon was removed and the weight loss was calculated.
Statistics Descriptive data are given as means (± SD) and ranges or as proportions. Weight loss data were analyzed on a per-protocol base. To calculate the excess weight, the ideal body weight was taken from the Metropolitan Life Insurance Tables for mid-frame subjects and subtracted from the actual body weight; percentage excess weight loss (% EWL) was calculated by dividing the weight loss by the excess weight. Patients were stratified by successful weight loss (≥ 10 % total body weight loss, a definition used by internists; and ≥ 50 % EWL, a definition used by surgeons). For comparison of groups, the student’s t test was used for normally distributed data and the Mann–Whitney U test was used for nonnormal data. Proportional data were compared using the chisquared test. A two-sided P value of < 0.05 was considered to represent a significant difference. Predictors of successful outcome (≥ 10 % total body weight loss) were investigated by univariate analysis, and variables with a P < 0.1 difference were entered into a logistic regression analysis. The Statistical Package for Social Sciences (SPSS) version 21.0 was used (IBM Corp., Armonk, New York, USA).
Mathus-Vliegen Elisabeth MH et al. Intragastric balloons in a private practice setting … Endoscopy 2015; 47: 302–307
303
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Original article
Original article
Table 1
Baseline patient characteristics.
Patients, mean ± SD (range) (n = 815) 36.5 ± 9.8 (12 – 71)
Age, years Body weight, kg
111.7 ± 22.7 (68.3 – 235.0)
BMI, kg/m 2
38.1 ± 6.4 (26.9 – 67.9)
Excess weight, kg
47.2 ± 20.0 (12.9 – 158.9)
Excess weight, %
40.6 ± 9.0 (15.9 – 67.6)
Duration of obesity (n = 53), years
16.9 ± 9.4 (2 – 38) 9.2 ± 4.3 (3 – 16)
Total number of diets (n = 17) Lifestyle factors, n (%) (n = 815) Smoking No smoking
554 (68.0)
1 – 10 cigarettes
64 (7.9)
10 – 20 cigarettes
81 (9.9)
≥ 20 cigarettes
97 (11.9)
Unknown
19 (2.3)
Alcohol No alcohol
565 (69.3)
1 – 3 units
212 (26.0)
3 – 6 units
14 (1.7)
6 – 9 units
1 (0.1)
≥ 9 units
1 (0.1)
Unknown
22 (2.7)
Co-morbidity, n (%) (n = 796) Type 2 diabetes mellitus
poned balloon removal to 9 months. Another 33 patients did not want to be weighed at the center. Therefore, 6-month weight loss data were available for 672 patients. The mean weight loss at 6 months was 20.9 ± 10.3 kg (range – 64.2 to + 1.7) corresponding to a mean body weight of 91.2 ± 20.7 kg. BMI decreased by 7.2 BMI units to a BMI of 31.2 ± 6.3 kg/m2 (range 19.8 – 63.6). Following balloon placement, 372 patients were only seen at 6 months for balloon removal. These patients, despite not receiving any dietary support or counselling, achieved a weight loss of 19.4 kg (6.6 BMI units). A total of 326 patients attended for weight consultation at 3 months and had lost 15.8 ± 6.5 kg (range – 47.4 to + 2.2), corresponding to a mean body weight of 99.2 ± 27.0 kg. BMI had decreased by 5.41 BMI units to a BMI of 33.8 ± 6.5 kg/m2 (range 20.0 – 59.0). Notably, in 65 patients, although the BMI increased 3 months after balloon removal to 34.1 ± 8.0 kg/m2, it remained 6.6 BMI units (18.8 kg) lower than the baseline level. Successful weight loss after 6 months as defined by internists (≥ 10 % total body weight loss) was achieved by 571 patients (85.0 %). Two patients lost as much as 40 % of their body weight " Fig. 3). Successful weight loss as defined by surgeons (≥ 50 % (● EWL) was achieved by 299 patients (44.5 %); 12 patients lost more than 100 % of their excess weight.
18 (2.3)
Medication for diabetes
18 (2.3)
Safety of balloon treatment
Cardiovascular disease
37 (4.6)
Balloons remained in place for a mean of 180.4 ± 61.6 days (range 1 – 390). In the first week, 36 patients (4.4 %) requested balloon removal for a variety of reasons, including physical discomfort, psychological intolerance, and geographical relocation. An additional 17 patients (2.1 %) requested to have the balloon removed within the first month. Complications consisted of two premature balloon removals because of dehydration and electrolyte disturbances, which required hospital admission (0.2 %). A total of 35 balloons (4.3 %) deflated prematurely and were passed rectally without any adverse events. However, two further balloons deflated and were not seen in the stomach at the 6-month endoscopy. A wait-and-see policy was followed for these patients, but intestinal obstruction " Table 2). Minor comensued, and surgery was required (0.2 %) (● plications that required balloon removal included one case of esophageal obstruction by impacted food in the presence of abnormal esophageal peristalsis and a balloon located high in the fundus, and five cases of hematemesis (not requiring hospital admission), among which one Mallory–Weiss tear was found at endoscopy. One woman became pregnant during therapy and the balloon was removed. Two transient gastric bleeds occurred during balloon removal when the grasper caught a mucosal fold of the stomach. Endoscopic records were available for 813 patients. In the other two patients, the endoscopic view was obscured by the transient bleed caused by the grasper. Inspection of the stomach revealed " Table 2). Severe esophagiabnormalities in 69 patients (8.5 %) (● tis was present in 12 patients (1.5 %), but this has not induced symptoms that required premature balloon removal.
Medication for cardiovascular disease Hypertension
8 (1.0) 124 (15.6)
Medication for hypertension
70 (8.8)
Osteoarthritis
71 (8.9)
Gallstones
40 (5.0)
Blood pressure, mmHg (n = 55) Systolic blood pressure
138 ± 18.0 (105 – 190)
Diastolic blood pressure
91 ± 12.5 (70 – 135)
Laboratory values, mean ± SD (range) (n = 35) Total cholesterol (< 5 mmol/L 1)
5.59 ± 1.17 (3.1 – 8.2)
LDL cholesterol (< 3 mmol/L 1)
3.50 ± 1.21 (0.9 – 5.8)
HDL cholesterol (1.1 – 2.0 mmol/L 1)
1.08 ± 0.32 (0.6 – 1.7)
Triglycerides (0.6 – 2.2 mmol/L 1)
2.30 ± 1.24 (0.6 – 6.5)
Fasting glucose (4.0 – 6.0 mmol/L 1)
5.19 ± 1.7 (4.0 – 11.9)
BMI, body mass index; LDL, low-density lipoprotein; HDL, high-density lipoprotein. 1 Normal healthy range.
Results !
A total of 815 patients were included (131 males [16.1 %], mean age 36.5 years, mean body weight 111.7 kg, mean BMI " Table 1). Seven patients were younger than 18 38.1 kg/m2) (● years and five were older than 60 years. A total of 30 patients had a BMI value between 26 and 30, and 213 had a BMI ≥ 40 kg/m2. Almost 70 % of patients did not use alcohol or tobacco. The presence or absence of co-morbidities (mainly hypertension and osteoarthritis) was known for the majority of patients (97.8 %). Blood pressure and laboratory values were known for only a few " Fig. 2 shows the flow chart of patients available for patients. ● the analysis of efficacy and safety.
Predictors of a successful outcome Efficacy of balloon treatment A total of 62 balloons were removed prematurely in the first months for personal or medical reasons. In 10 patients, the balloons were prematurely removed just before the end of the 6month period for logistical reasons. A total of 30 patients had their weights measured only at 3 months. Eight patients post-
Sex, age, baseline BMI and body weight, the presence of co-morbidities, and lifestyle habits may determine the extent of body weight loss. A successful weight loss of ≥ 10 % initial weight was achieved by 571 patients. In the 101 unsuccessful patients, diabetes was present in three times as many patients and osteoarthritis was present in double the number of patients compared
Mathus-Vliegen Elisabeth MH et al. Intragastric balloons in a private practice setting … Endoscopy 2015; 47: 302–307
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
304
Original article
Fig. 2
Balloon placement in eligible patients (N = 815)
305
Flow-chart of patients through the study.
Primary outcome
Weight loss data at 6 months (n = 672), of whom 372 only visited the center at balloon placement and removal
Safety data at balloon removal (n = 815)
Secondary outcome
Weight loss data at 3 months (n = 326)
Endoscopy data at removal (n = 813) ▪ 2 removal-associated bleedings with a limited endoscopy report
Weight loss data at 9 months (n = 65)
Fig. 3 Weight loss stratified by percentage total body weight loss and percentage excess weight loss.
50 % weight loss
Patients (%)
40
% excess weight loss
30
20
10
0 0–10 20–30 40–50 10–20 30–40
Table 2
0–10 20–30 40–50 60–70 80–90 >100 10–20 30–40 50–60 70–80 90–100
Complications of intragastric balloon therapy.
n (%) Balloon-related complications (n = 815)
48 (5.9)
Major
4 (0.5)
Dehydration, electrolyte disturbances
2 (0.2)
Balloon deflation, intestinal obstruction, and surgical intervention
2 (0.2)
Minor
1 (0.1)
Pregnancy requiring balloon removal
1 (0.1)
Gastric hemorrhage with hematemesis requiring balloon removal
5 (0.6)
Balloon deflation with uneventful rectal evacuation
35 (4.3)
Gastric hemorrhage during balloon removal
Discussion !
44 (5.4)
Esophageal food obstruction requiring balloon removal
Findings at endoscopy (n = 813)
" Table 3). Logistic regreswith the successful weight loss group (● sion analysis could not be performed, however, as all statistical conditions (normal distribution of data and absence of autocorrelation and collinearity) were not fulfilled.
2 (0.2) 69 (8.5)
Esophagitis grade I
19 (2.3)
Esophagitis grade II
31 (3.8)
Esophagitis grade III
12 (1.5)
Gastric erosions
7 (0.9)
To our knowledge, this is the first study to examine the efficacy and safety of intragastric balloon treatment outside the academic medical or bariatric surgery center environment and outside a clinical trial. The study showed that patients lost a mean of 15.8 kg and 20.9 kg after 3 and 6 months of balloon therapy, respectively, suggesting that over 75 % of the weight loss during balloon therapy occurs during the first 3 months. Importantly, patients who were not seen between the time of balloon placement and removal, lost 19.4 kg of weight, suggesting that nutritional follow-up during balloon therapy may not be as critical to success as previously thought. This study confirmed the finding reported in the literature that patients with diabetes have more difficulty in losing
Mathus-Vliegen Elisabeth MH et al. Intragastric balloons in a private practice setting … Endoscopy 2015; 47: 302–307
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Reason for having no weight loss measurements at 6 months ▪ Balloon removal at own request (n = 53) in first month ▪ Balloon removal for medical reasons (n = 9) within 2 months ▪ Balloon removal for logistical reason (n = 10) before 6 months ▪ Weight measured only at 3 months (n = 30) ▪ Weight measured only after 9 months (n = 8) ▪ Refused to be weighed at the center (n = 33)
Original article
Patients, n Age, years
Unsuccessful weight loss
Successful weight loss
< 10 % initial body weight
≥ 10 % initial body weight
101
571
37.2 ± 9.6
P value
35.3 ± 9.6
0.180
Sex, n Male Female Baseline body weight, kg
0.435 18 83
487 84
105.7 ± 17.9
110.5 ± 20.2
Baseline BMI, kg/m 2
36.4 ± 6.0
38.0 ± 5.8
0.058
Body weight at 6 months, kg
98.8 ± 16.6
88.2 ± 32.4
0.017
BMI at 6 months, kg/m 2
34.0 ± 5.5
30.4 ± 13.0
0.042
6.9 ± 3.3
23.6 ± 9.4
< 0.001
Weight loss, kg Weight loss, %
0.090
6.5 ± 2.9
21.3 ± 7.1
< 0.001
Balloon in place, days
196.1 ± 38.4
196.3 ± 37.5
0.971
Co-morbidity, n (%)
101
557
Diabetes Hypertension Cardiovascular disease Osteoarthritis Lifestyle habits, n (%)
Table 3 Predictors of successful weight loss.
6 (5.9)
10 (1.8)
0.015
10 (9.9)
95 (17.1)
0.072
8 (7.9)
23 (4.1)
0.099
17 (16.8)
40 (7.2)
0.002
101
571
Smoking
25 (24.8)
190 (33.3)
0.089
Alcohol intake
35 (34.7)
171 (30.0)
0.347
BMI, body mass index.
weight. Patients with osteoarthritis also found it harder to lose weight, possibly because of their reduced ability to adequately follow the physical exercise advice. It is reassuring that sex, age, baseline BMI and body weight, and lifestyle habits did not influence the extent of weight loss. A previous study attempted to isolate the effects of balloons on weight loss outcomes. In the 1980 s, Borody conducted a doubleblind, randomized trial in 20 patients who received either a Ballobes balloon (DOT ApS; Rödovre, Denmark) filled with 500 mL of air for 16 weeks, or a sham insertion procedure following an endoscopy [19]. In order to exclude the benefits of dietary and behavioral follow-up, none of the patients received supportive consultations. All 20 patients returned to the clinic for balloon removal after 16 weeks. There was a weight loss of 10.6 % (range 2.4 % – 23.1 %) in the balloon group and 0.6 % in the sham group (P < 0.02). Two randomized, double-blind, placebo-controlled trials have been performed by our group [20, 21]. In the first trial, which used the Ballobes balloon, there was no difference between the four treatment groups (2 × 4-month treatment of balloon – sham, balloon – balloon, sham – balloon, or sham – sham) [20]. All four groups lost 50 kg in 8 months, but this might have been due to the very intensive guidance and lifestyle program that accompanied balloon treatment. In the second study, which used the BioEnterics Intragastric Balloon, there was no difference between the first 13 weeks of balloon treatment and the sham treatment [21]. Genco et al. demonstrated a clear benefit of balloon treatment in a crossover design [22], whereas Martinez-Brocca et al. found no differences between balloon and sham treatment in a parallel design [23]. In all of these studies, however, patients in both groups were followed weekly or biweekly, and all received intensive additional lifestyle support. The current report is the first study in which a substantial number of patients who did not receive dietary and nutrition follow-up achieved a weight loss comparable with those who did. In The Netherlands, only bariatric surgery is reimbursed by health insurance companies. Intensive lifestyle intervention,
pharmacotherapy, and intragastric balloon treatment must be paid for by the patients themselves. Specialist outpatient clinics offer these kinds of treatments. One explanation for the beneficial results may be that outside a clinical trial, patients are paying for intragastric balloon therapy and may feel a financial motivation – and also social pressure – to achieve the best results possible. Most importantly, this study demonstrates that balloons can be used safely in private practice, especially when patients are strongly advised to return after 6 months to have the balloon removed and when patients with previous abdominal surgery are excluded. Balloons remaining in the stomach for longer than the prescribed 6 months or patients who have undergone previous abdominal surgery have been shown to be at higher risk of complications [6]. In the current study, eight patients postponed balloon removal for up to 9 months without adverse events. Follow-up data on the safety of balloons was obtained for all 815 patients. Both major (0.5 %) and minor (5.4 %) complications were surprisingly infrequent given that these balloons were administered in private practice with less frequent follow-up than in an academic medical center environment or at bariatric surgery centers. Interestingly, however, even though patients were paying for their balloons, the incidence of early removals (7.6 %; 62/815) was double the figure reported in a recent meta-analysis (4.2 %) [8]. Moreover, the rate at which patients voluntarily requested balloon removal was 6.5 % in the current study, compared with only 1.8 % in previous series [8]. This suggests, that patients may not have been well informed about the initial side effects of balloon therapy and the need for adequate medication to overcome symptoms. This result highlights the need to clearly prepare patients for these early side effects. The deflation rate of 4.5 % is the same as that reported in a recent meta-analysis [8]. The collective frequency of relevant gastrointestinal complications, such as gastric hemorrhage, esophageal obstruction, and esophagitis grade II and III (6.0 %; 49/815) is similar to the rate reported in the litera-
Mathus-Vliegen Elisabeth MH et al. Intragastric balloons in a private practice setting … Endoscopy 2015; 47: 302–307
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
306
ture (5.2 %) [8]. Esophagitis was not a reason for premature balloon removal and was often an unexpected finding. Although this study has many strengths, such as complete safety follow-up for the entire cohort, it also has several limitations. No information was available about the characteristics of the patients who were able to pay, and therefore motivated to undergo, this treatment. The design was retrospective, and therefore some data were easy to retrieve, but important obesity-related variables (e. g. family history, age of menarche, age of onset of obesity, previous weight loss attempts, and weight losses achieved) were lacking. Also, data on the improvement of co-morbid conditions could not be retrieved as the clinics had no access to laboratory facilities. Finally, as the patients were not followed as closely as in previous trials, some complications may have gone unreported. Interestingly, despite being in a private practice setting, 65 patients returned for follow-up 3 months after balloon removal. They had regained 15 % of the weight lost but were still 6.6 BMI units (18.8 kg) below their baseline body weights. This is a particularly valuable result, as this information “in the free-living condition” is not usually available. A previous meta-analysis showed that 1 year after balloon removal, 6.3 kg of the 15.9 kg lost at balloon removal was regained in 133 patients [8, 21, 24]. In 100 patients studied by Negrin Dastis et al., 63 % attained a 10 % weight loss at balloon removal and 24 % of patients maintained their 10 % weight loss after 2.5 years [25]. Kotzampassi et al. demonstrated that of the 393 successful patients (success defined as a ≥ 20 % EWL after 6 months of balloon treatment), 53 %, 27 %, and 23 % maintained a ≥ 20 % EWL after 12, 24, and 60 months, respectively [26]. It will be important to collect similar long-term follow-up data on weight regain in private practice. In conclusion, intragastric balloon therapy may fill the gap in a therapeutic vacuum between weight loss drugs and surgery [27, 28]. Even in private practice, patients were able to lose clinically meaningful amounts of weight. Moreover, this weight loss can be achieved with minimal complications. As balloon use in private practice grows, it will be critical to ensure that patients return after 6 months to have the balloon removed, as patients lost to follow-up are more likely to experience balloon deflation and intestinal obstructions. Future studies will assess the costs and benefits of intragastric balloon therapies compared with intensive lifestyle intervention with or without pharmacotherapy. Competing interests: Dr. Chuttani holds an equity position with Allurion Technologies. Institutions 1 Department of Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands 2 General Practice, Wieringerwerf, The Netherlands 3 Beth Israel Deaconess Medical Center and Harvard School, Boston, Massachusetts, United States 4 Gelre Hospital, Apeldoorn, The Netherlands
References 1 World Health Organization. Obesity: preventing and managing the global epidemic. Report of a WHO Consultation on Obesity, Geneva, 3–5 June 1997. Report No.: WHO/NUT/NCD/98.1 Geneva: WHO; 1998 2 National Institutes of Health and National Heart. Lung and Blood Institute. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults – the evidence report. Obes Res 1998; 6: 1S – 209S 3 Isidro L, Cordido F. Approved and off-label use of obesity medications, and potential new pharmacologic treatment options. Pharmaceuticals 2010; 3: 125 – 145
4 de Moura EG, Orso IR, Martins BC et al. Improvement of insulin resistance and reduction of cardiovascular risk among obese patients with type 2 diabetes with the duodenojejunal bypass liner. Obes Surg 2011; 21: 941 – 947 5 Fernandes M, Atallah AN, Soares BG et al. Intragastric balloon for obesity. Cochrane Database Syst Rev 2007; 1: CD004931 6 Mathus-Vliegen EM. Intragastric balloon treatment for obesity: what does it really offer? Dig Dis 2008; 26: 40 – 44 7 Dumonceau JM. Evidence-based review of the Bioenterics intragastric balloon for weight loss. Obes Surg 2008; 18: 1611 – 1617 8 Imaz I, Martinez-Cervell C, Garcia-Alvarez EE et al. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. Obes Surg 2008; 18: 841 – 846 9 Espinet-Coll E, Nebreda-Duran J, Gomez-Valero J et al. Current endoscopic techniques in the treatment of obesity. Rev Esp Enferm Dig 2012; 104: 72 – 87 10 Machytka E, Klvana P, Kornbluth A et al. Adjustable intragastric balloons: a 12-month pilot trial in endoscopic weight loss management. Obes Surg 2011; 21: 1499 – 1507 11 Martin CK, Bellanger DE, Rau KK et al. Safety of the Ullorex oral intragastric balloon for the treatment of obesity. J Diabetes Sci Technol 2007; 1: 574 – 581 12 Mion F, Ibrahim M, Marjoux S et al. Swallowable Obalon® gastric balloons as an aid for weight loss: a pilot feasibility study. Obes Surg 2013; 23: 730 – 733 13 Busetto L, Segato G, De Luco M et al. Preoperative weight loss by intragastric balloon in super-obese patients treated with laparoscopic gastric banding: a case-control study. Obes Surg 2004; 14: 671 – 676 14 Marino M, Busetto L, Giardiello C et al. BioEnterics intragastric balloon: the Italian experience with 2,515 patients. Obes Surg 2005; 15: 1161 – 1164 15 Melissas J, Mouzas J, Filis D et al. The intragastric balloon – smoothing the path to bariatric surgery. Obes Surg 2006; 16: 897 – 902 16 Loffredo A, Cappuccio M, De Luca M et al. Three years experience with the new intragastric balloon, and a preoperative test for success with restrictive surgery. Obes Surg 2001; 11: 330 – 333 17 Loffredo A, Cappuccio M, De Luca M et al. BIB test and patient selection in the treatment of morbid obesity. Obes Surg 2001; 10: 326 – 328 18 de Goederen-van der Meij S, Pierik RGJM, Oudkerk Pool M et al. Six months of balloon treatment does not predict the success of gastric banding. Obes Surg 2007; 17: 88 – 94 19 Borody TJ. Double blind study of Ballobes intragastric balloon without diet or behaviour medication. Ballobes symposium Stockholm, Sweden: 04. 06. 1988: Available from: http://www.cdd.com.au/pdf/ publications/All%20Publications/1988-Double%20blind%20study% 20of%20Ballobes%20intragastric%20balloon%20without%20diet%20or %20behaviour%20modification.pdf [Accessed: September 2014] 20 Mathus-Vliegen EM, Tytgat GN, Veldhuyzen-Offermans EA. Intragastric balloon in the treatment of super-morbid obesity. Double-blind, sham-controlled, crossover evaluation of 500-milliliter balloon. Gastroenterology 1990; 99: 362 – 369 21 Mathus-Vliegen EM, Tytgat GN. Intragastric balloon for treatment-resistant obesity: safety, tolerance, and efficacy of 1-year balloon treatment followed by a 1-year balloon-free follow-up. Gastrointest Endosc 2005; 61: 19 – 27 22 Genco A, Cipriano M, Bacci V et al. BioEnterics Intragastric Balloon (BIB): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients. Int J Obes (Lond) 2006; 30: 129 – 133 23 Martinez-Brocca MA, Belda O, Parejo J et al. Intragastric balloon-induced satiety is not mediated by modification in fasting or postprandial plasma ghrelin levels in morbid obesity. Obes Surg 2007; 17: 649 – 657 24 Herve J, Wahlen CH, Schaeken A et al. What becomes of patients one year after the intragastric ballon has been removed? Obes Surg 2005; 15: 864 – 870 25 Negrin Dastis S, Francois E, Deviere J et al. Intragastric balloon for weight loss: results in 100 individuals followed for at least 2.5 years. Endoscopy 2009; 41: 575 – 580 26 Kotzampassi K, Grosomanidis V, Papakostas P et al. 500 intragastric balloons: what happens 5 years thereafter? Obes Surg 2012; 22: 896 – 903 27 Ibrahim M, Blero D, Deviere J. Endoscopic options for the treatment of obesity. Gastroenterology 2010; 138: 2228 – 2232 28 Delegge MH. Endoscopic approaches for the treatment of obesity: fact or fiction? Nutr Clin Pract 2011; 26: 534 – 538
Mathus-Vliegen Elisabeth MH et al. Intragastric balloons in a private practice setting … Endoscopy 2015; 47: 302–307
307
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Original article
Copyright of Endoscopy is the property of Georg Thieme Verlag Stuttgart and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
