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Efficacy of Intragastric Balloon Treatment for Adolescent Obesity

Ricardo José Fittipaldi-Fernandez, Marcella Rodrigues Guedes, Manoel P. Galvao Neto, Márcia Regina Simas Torres Klein, et al. Obesity Surgery The Journal of Metabolic Surgery and Allied Care ISSN 0960-8923 OBES SURG DOI 10.1007/s11695-017-2699-1

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Author's personal copy OBES SURG DOI 10.1007/s11695-017-2699-1

ORIGINAL CONTRIBUTIONS

Efficacy of Intragastric Balloon Treatment for Adolescent Obesity Ricardo José Fittipaldi-Fernandez 1 & Marcella Rodrigues Guedes 1 & Manoel P. Galvao Neto 2,3 & Márcia Regina Simas Torres Klein 4 & Cristina Fajardo Diestel 1,4

# Springer Science+Business Media New York 2017

Abstract Background Several studies conducted in adults suggest that intragastric balloon (IGB) is an effective and safe method for weight loss. Although the prevalence of obesity in adolescents has increased in recent years, the outcomes of IGB treatment in this age group are not known. The aim of this study was to evaluate the safety and efficacy of IGB treatment for weight loss in adolescents followed up for 6 months. Methods This is a retrospective longitudinal study including 27 adolescents (14–19 years; 23 female). All participants were referred to IGB treatment by their attending physician, presented body mass index (BMI) ≥ 29 kg/m2 (>p97 BMI/age index) and failed to lose weight in clinical treatments. A liquid-filled nonadjustable IGB with a volume of 600 to

* Ricardo José Fittipaldi-Fernandez [email protected]

700 ml was used for 6 months. All patients were included in a multidisciplinary program, and adherence to this program was evaluated as the number of attended appointments. Results There were no serious complications or deaths. The BMI decreased from 37.04 to 31.18 kg/m2 (p < 0.0001), body weight decreased from 102.21 to 86.23 kg (p < 0.0001), and excess weight diminished from 35.18 to 19.12 kg (p < 0.0001). The % excess weight loss (%EWL) was 56.19 and % total weight loss (%TWL) 16.35. Adherence to the multidisciplinary program correlated directly with %EWL (r = 0.55; p = 0.0033) and %TWL (r = 0.53; p = 0.0052). Conclusion Endoscopic treatment of obesity with an IGB is safe, effective, and may be an emerging therapeutic option for adolescents. Keywords Intragastric balloon . Obesity . Overweight . Adolescents . Weight loss

Marcella Rodrigues Guedes [email protected]

Introduction

Manoel P. Galvao Neto [email protected]

Overweight and obesity are a global public health problem and, in the USA, the obesity rate among adolescents has quadrupled in the last 30 years [1–3]. As adults, obese youths are more likely to have risk factors for cardiovascular disease, such as dyslipidemia, high blood pressure, type 2 diabetes mellitus (T2DM), degenerative joint disease, non-alcoholic steatohepatitis (NASH), and obstructive sleep apnea (OSA) [4–6]. In a population-based sample of children and adolescents aged 5 to 17 years, 70% of obese youths had at least one risk factor for cardiovascular disease [7]. Moreover, childhood overweight often tracks into adulthood [8]. In all age groups, the treatment of overweight is based on changes in lifestyle, including healthy eating, increased physical activity and exercise, as well as,

Márcia Regina Simas Torres Klein [email protected] Cristina Fajardo Diestel [email protected] 1

EndogastroRio Clinic, 43/1101, Siqueira Campos Street, Rio de Janeiro/RJ 22031-901, Brazil

2

Gastro Obeso Center, Sao Paulo, Brazil

3

Florida International University, Miami, FL, USA

4

Department of Applied Nutrition, Nutition Institute, Rio de Janeiro State University, 12th floor/524, São Francisco Xavier Street, Rio de Janeiro/RJ 20550-900, Brazil

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occasionally, psychotherapeutic support [9, 10], possibly in combination with medication as a second-line therapy [11]. When conservative methods fail, there are other possible options such as obesity surgery and intragastric balloon (IGB) [12]. Of the various treatment options, the placement of an IGB has been considered an effective, reversible, and less invasive non-surgical method for weight loss in adult patients with a body mass index (BMI) >27 kg/m2 who have experienced poor results with dietary programs, drug treatment, and behavioral therapy [13, 14]. It is also recommended as a weight reduction adjuvant therapy before bariatric surgery [15]. The IGB provides a continuous sensation of satiety that helps patients to restrict themselves to smaller portions of food, thus facilitating maintenance of a low-calorie diet [15]. To date, only a few studies, conducted with a small number of subjects, have evaluated the use of IGB in adolescents [16–18]. As the prevalence of obesity in adolescents is increasing and IGB is a treatment option for obesity, there is a need for studies evaluating its safety and efficacy in this age group. The aim of this study was to evaluate the safety and the efficacy of IGB treatment for weight loss in adolescents followed up for 6 months.

Patients and Methods This retrospective longitudinal study included 27 adolescent patients undergoing IGB treatment at a private clinic between January 2010 and December 2016. The inclusion criteria were as follows: adolescent patients (14–19 years) with a BMI ≥ 29 kg/m2 (>97th percentile of BMI/age) that had failed to lose weight in well-conducted clinical treatments of overweight/obesity. All these patients were referred to the service with a written request for IGB treatment from their attending physician. The exclusion criteria were adults or elderly patients, obesity of hormonal or genetic causes, alcohol or illicit drug abuse, malignant disease, and pregnancy. A preliminary interview established medical history, including previous attempts to lose weight, co-morbidities, and the impact of their obesity, both socially and psychologically. Balloon Placement Balloon insertion was performed after a diagnostic endoscopy to detect pathologies that might contraindicate balloon placement, such as active peptic ulcer, grade C-D esophagitis, large volume hiatal hernia, esophageal/fundus varices, esophageal strictures, and prior gastric surgery. The endoscopy procedure was performed under deep sedation without endotracheal intubation, with continuous oxygen support of 5 l/min, under the supervision of an anesthesiologist. After implant of the balloon, correct positioning was

checked endoscopically, with the balloon valve positioned 2 cm below the cardia. The balloon inflation was under direct vision with the endoscope in rear view position (U-turn maneuver). The balloon was filled with 3% saline solution and 10 ml of 4% methylene blue. The balloon volume ranged from 600 to 700 ml. After filling, the balloon valve was closed with a syringe vacuum and the catheter disconnected by traction. Then, the balloon was visually inspected to detect possible deflation or valve malfunctions and to confirm correct positioning in the gastric fundus. If a leakage was detected, a prompt replacement of the defective balloon was conducted. Follow-Up After balloon placement, patients remained in the anesthesia recovery room until complete recovery from sedation had been confirmed and were then discharged. Instructions were provided for a 5-day liquid diet (with progressive increase in ingested volume). On the sixth day, a semi-solid diet was prescribed and, after the thirteenth day, solids were introduced into a diet of 1200 kcal/day. Thereafter, the patients were referred for personalized nutritional counseling, when an individual diet was prescribed within a range of 10–15 kcal/kg/ day. All patients were followed up by a multidisciplinary team with scheduled medical, nutritional, and psychological appointments at least 15, 30, 60, 90, 120, and 150 days after balloon placement. In the first 3 days after balloon insertion, patients were instructed to use three antiemetic drugs (metoclopramide, ondansetron, and dimenhydrinate), an anti-foaming drug (dimethicone), and analgesics/antispasmodics (escopolamine plus dipyrone, acetaminophen). All patients were put on a proton pump inhibitor (PPI; pantoprazole magnesium) throughout the treatment: a double dose in the first month (80 mg) and a full dose from the second month to the end (40 mg). Additionally, vitamin and mineral supplementation and probiotics (Lactobacillus acidophilus LA 16) were given to all patients during the entire treatment. Balloon Retrieval Retrieval was routinely scheduled for 6 months but occurred within a minimum of 180 and a maximum of 210 days after balloon implantation. Removal was preceded by a 5-day clearfluid diet, in order to minimize the risk of residual food entering the trachea. Deep intravenous anesthesia without tracheal intubation was performed with the patient in a left lateral decubitus position. The presence of solid food waste in the stomach resulted in cancelation of the procedure and a new procedure was scheduled with adequate preparation. After insertion of the gastroscope in the stomach, a needle-catheter was inserted through the working channel of the gastroscope

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and introduced into the IGB after puncture. The needle was then withdrawn, and a vacuum was applied to the catheter in order to empty the balloon. Following intravenous administration of scopolamine for relaxation of the upper esophageal sphincter, the catheter was removed and the balloon was grasped with foreign-body forceps and/or a polypectomy snare and slowly extracted through the esophagus. There were no cases of bronchial aspiration. After balloon removal, endoscopy was performed to detect possible damage caused by the passage of the balloon. Anthropometrics Anthropometric measures were obtained at the baseline (day of IGB insertion) and 6 months later, at the end of the study (day of IGB removal). Height was measured with a stadiometer accurate to ±0.5 cm, and weight was obtained using a calibrated scale accurate to ±0.1 kg after participants, without shoes and wearing light clothing, attempted to empty their bladder. BMI was calculated using the standard equation (kg/m2).

Results The baseline characteristics of the participants are reported in Table 1. Eighteen patients had no co-morbidities, four had hypertension, three had dyslipidemia, one had insulin resistance, and one was a kidney transplant recipient. There were no complications or deaths during treatment. At the end of the treatment, the mean weight loss was 15.99 kg, the %TWL was 16.35, and %EWL was 56.94 (Table 2). In terms of %EWL, four patients (15%) did not meet the treatment goal (EWL < 20%), while treatment was successful (EWL 20–50%) or highly successful (EWL > 50%) in 10 (37%) and 13 (48%) patients, respectively. According to the %TWL, seven patients (25.92%) did not achieve treatment success (TWL < 10%). Eleven patients finished the study at or under the 97th percentile for BMI/age (Table 3). Only one adolescent (3.7%) did not attend any of the scheduled nutritional and psychological consultations. Adherence to the multidisciplinary program presented a significant positive correlation with %EWL (r = 0.5540, p = 0.0033) and %TWL (r = 0.5265, p = 0.0057) (Fig. 1).

Outcomes

Discussion The outcomes included safety indicators (complications of the treatment) and efficacy indicators such as weight loss (kg), change in BMI (kg/m2), % total weight loss (%TWL), and % excess weight loss (%EWL) during the 6 months of balloon use. The success of the treatment was evaluated according to %TWL (≥10%) and %EWL: patients divided into those who did not achieve the goal of the treatment (50%). The success of the treatment was also evaluated as the achievement of a BMI/age in accordance with the World Health Organization recommendations for teenagers [19]. Adherence to the multidisciplinary program was evaluated as attendance at nutritional and psychological consultations and classified as the number of consultations attended.

The continuing rise of overweight/obesity rates and the lack of effective medical treatments with pharmacotherapy and the variable and modest effect of diet programs on weight loss make the IGB a good alternative [20]. The IGB is a reversible non-surgical treatment approved in Brazil for overweight and obesity and, furthermore, has been recommended as a weight reduction adjuvant before bariatric surgery and before all kinds of planned surgery in the morbidly obese, as a way of reducing life-threatening co-morbidities and lessening surgical risk. Because the IGB theoretically affects both the stretch receptors and gastric capacity, it increases satiety, while decreasing the residual volume available for food and prolonging gastric emptying. It can therefore be considered a restrictive obesity treatment procedure [21].

Statistical Analysis The Kolmogorov-Smirnov test for normality was used to confirm the normal distribution of the variables. The results are presented as mean ± standard deviation and minimal–maximal values for continuous variables and absolute numbers (percentage) for categorical variables. A paired Student’s t test was used for comparisons between values obtained for the baseline and at the end of the treatment. The Spearman correlation was used to confirm whether the number of multidisciplinary consultants was related to the %EWL and %TWL. All statistical analyses were performed using STATA (v.12.0, Stata Corp, College Station, TX, USA) and a p value of percentile 97

17.41 ± 1.25 (14–19) 4 (14.81%) 23 (85.19%) 102.11 ± 25.8 (63–194) 37.04 ± 6.29 (29.71–56.59) 27 (100%)

Mean values with their standard deviations (minimum-maximum); number of subjects and percentages.

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Total group

a

175 150

(n = 27)

Baseline Final Reduction %TWL BMI (kg/m2) Baseline Final Reduction Excess weight (kg) Baseline

102.21 ± 25.8 86.23 ± 27.34

%EWL

125

Body weight (kg)

100 75 50

15.99 ± 5.87.2

25

16.35 ± 9.58

0

37.04 ± 6.29 31.18 ± 7.46 5.87 ± 3.4

19.12 ± 22.29

%EWL

56.94 ± 38.63

b

p97

16 (59.26%)

>p85–p97

7 (25.93%)

>p50–p85

3 (11.11%)