Effects of Intragastric Balloon in Patients With Non-alcoholic Fatty Liver Disease and Advanced Fibrosis

Federico Salomone; Walter Currenti; Giovanni Magrì; Ivo Boškoski; Shira Zelber-Sagi; Fabio Galvano


Liver International. 2021;41(9):2112-2116. 

In This Article

Patients and Methods

A single-center cohort of 26 obese patients with NAFLD and clinically significant fibrosis was retrospectively studied. The cohort was composed by obese individuals consecutively seen at the Division of Gastroenterology of Acireale Hospital (Sicily) that underwent IGB placement between January 2019 and June 2020. Indications to the placement of the IGB Orbera™ (Apollo Endosurgery, Austin, TX), formerly BioEnterics Intragastric Balloon (BIB), were BMI between 30 and 40 kg/m2, a previous failure to lifestyle change interventions, and at least one obesity-associated morbidity such as dyslipidemia, glucose abnormalities, hypertension or osteoarticular comorbidities. Advanced liver fibrosis was defined as liver stiffness ≥ 9.7 kPa corresponding to F3, and stiffness ≥ 13.6 kPa corresponding to F4.[12] Liver stiffness and controlled attenuation parameter (CAP) were measured by Fibroscan 502 (Echosens, France) by a single operator (FS).

All patients were characterized for metabolic features at baseline before the placement of IGB and at the end of the 6-month study period. According to the manufacturer's instructions, BIB/Orbera™ was placed in patients without portal hypertension (esophageal varices, hypertensive gastropathy), hiatal hernia > 5 cm, active peptic ulcer, prior foregut surgery, esophagogastric neoplasms, pregnancy. Under deep sedation, the deflated IGB was introduced in the stomach and then filled with 650 ml of saline solution plus methylene blue (1% 10 ml). Intravenous omeprazole 40–80 mg/day and antiemetic therapy (ondansetron 8–16 mg/day or one single-dose of netupitant 300 mg/palonosetron 0.5 mg) were given intraoperatively and for the first 3 days following IGB placement. Successively antiemetics, antispasmodic drugs, and laxatives were prescribed on demand, whereas proton pump inhibitor (pantoprazole 40–80 mg/day) were maintained for the whole period.

During the 6-month treatment with IGB, patients were followed by a single dietitian (WC) and underwent a hypocaloric regimen based on a daily intake of about 1,000–1,300 kcal/day (~1,000 kcal calorie deficit). The total daily energy expenditure of each patient was calculated by Mifflin formula, corrected for physical activity. The approximate macronutrient distribution was 25%–30% protein (at least 60 g/day), 45%–50% carbohydrates and 25%–30% lipids according to Italian Recommended Nutrients Levels. Dietary plans were calculated using a software (Metadieta, Meteda srl, S. Benedetto del Tronto, Italy) and customized according to the patient's preferences providing a list of the recommended daily intake of commonly used foods, along with a substitution list to allow for some exchange of foods. Patients were also advised to start their meals with protein foods (meat, fish, low-fat cheeses, eggs), vegetables and at the end complex carbohydrates (whole-bread, rice, potatoes, whole-wheat pasta) to preserve fat-free mass, improve satiety and also easily meet micronutrients requirement.

In the first 24 h after IGB placement, only fluid hydration was permitted. During the first 10 days, a gradual progression from liquid (low-fat milk or yogurt, non-sweetened fruit juices and vegetable broth) to semi-liquid diet (pureed meat\fish, vegetable soup, semolina pudding and cottage cheese) was recommended. Subsequently, patients proceeded with caution to the hypocaloric, balanced, and solid diet described before (Figure S1). During the six months, patients were also encouraged to practice aerobic activity for 30 min daily at least 3 days a week. Dietitian follow-up included one phone call in the first week, then bimonthly visits for the 6 mo. Patients were asked to bring a three nonconsecutive day dietary log at each follow-up visit to assess the compliance to the diet.

Statistical Analysis

Statistical analysis was performed by GraphPad Prism 8 (GraphPad Software, CA). Continuous variables are presented as mean ± SD or median [interquartile range, IQR], based on data distribution, established by D'Agostino & Pearson normality test. Differences from baseline to follow-up were assessed by paired t test or Wilcoxon signed ranks test according to data distribution for continuous variables and by Fisher exact test for the categorical variable (liver fibrosis stage).