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

Disclosures

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

In This Article

Results

General Features of the Study Population

The main features of the study population are shown in Table S1. The median age was 53 [44 - 62] years; 69% of the cohort were men. The mean BMI was 35.1 ± 4.7 kg/m2. All patients were in the prediabetes (16/26, 62%) or diabetes (10/26, 38%) range; 65% of patients had arterial hypertension; 73% had dyslipidemia (hypercholesterolemia, hypertriglyceridemia, or both); 15% were active smokers. Eighteen patients had liver stiffness 11.5 ± 1.07 kPa corresponding to F3 (≥9.7 and <13.6 kPa), eight patients had 17.5 ± 2.45 kPa corresponding to F4 (stiffness ≥ 13.6 kPa). Liver stiffness values were obtained with the XL probe in five patients.

In agreement with Orbera™ IGB indication, none of the patients presented endoscopic signs of portal hypertension (esophageal varices or hypertensive gastropathy). Diabetic patients were treated with metformin plus insulin in three cases. Treatments for hypercholesterolemia included red fermented rice extracts, statins, or ezetimibe; hypertriglyceridemia was treated with fibrates. None of the patients were on treatment with antioxidants (vitamin E, milk thistle extracts, vitamin D) or drugs with proven efficacy on liver fibrosis during the study period.

Effects of IGB on Metabolic and Liver Parameters

In the first week after IGB placement, most of the patients displayed nausea/vomiting, gastroesophageal reflux symptoms and epigastric pain, which were adequately managed with proton pump inhibitors, anti-acids, and anti-emetics. No severe adverse event was observed during the whole period. Effects of IGP on metabolic and liver parameters are shown in Table 1. Following the lifestyle change intervention established by the dietitian, all patients achieved a significant total bodyweight loss (TBWL) at 6-month follow-up after IGB placement (106 ± 19.7 vs. 92 ± 18.3 kg, P < .001). Sixteen patients displayed a TBWL > 10% whereas in ten patients TBWL was 7%–10% (Figure 1). Patients displayed a healthy weight loss as showed by a reduction of waist circumference (116 ± 13.3 vs. 104 ± 13.4 kg, P < .001) and of body fat percentage (45.8 ± 8.2% vs. 38.5 ± 8.5, P < .001) and a consistent increase of fat-free mass percentage (54.2 ± 8.4% vs. 61.5 ± 8.5, P < .001).

Figure 1.

The retrospective cohort was composed of 26 obese NAFLD patients with advanced fibrosis defined as liver stiffness ≥9.7 ≤ 13.5 kPa, corresponding to F3 (n = 18), or ≥13.6 kPa, corresponding to F4 (n = 8). Patients underwent a six-month treatment with the Orbera™ intragastric balloon. All patients achieved a significant total body weight loss (TBWL). Sixteen patients displayed a TBWL>10% whereas in ten patients TBWL was 7%–10%. Almost all patients that experienced a weight loss >10% obtained a regression of fibrosis stage (panel A). Overall, fifteen patients had a regression of fibrosis stage. Eleven patients remain at the same liver fibrosis stage although they also displayed a reduction of liver stiffness. Eleven patients among eighteen passed from F3 to F2 (P < .001) and 4/8 moved from F4 to F3 (P < .001) (panel B). Weight loss induced by IGB reduced liver stiffness from 13.3 ± 3.2 to 11.3 ± 2.8 kPa in the whole cohort (panel C).

Weight loss induced by IGB led to reduced plasma fasting glucose (140 [112,169] vs. 118 [94; 144] mg/dl, P < .01), glycated hemoglobin (7.5% ± 1.3% vs. 6.6% ± 1.2, P < .001), total cholesterol (214.2 ± 45.6 vs. 196.3 ± 43.2 mg/dl, P < .05) but not triglycerides (203.6 ± 78.5 vs. 185.3 ± 70.7 mg/dl, NS). Consistently, at the 6-month follow-up, patients had reduction of AST (72.1 ± 40.3 vs. 34.3 ± 22.4 UI/l, P < .001), ALT (84.5 ± 42.3 vs. 46.7 ± 24.6 UI/l, P < .001), ɣGT (136 ± 51 vs. 94 ± 62 U/l, P < .01), FIB-4 (3.2 ± 0.7 vs. 2.7 ± 0.8, P < .001), liver stiffness (13.3 ± 3.2 vs. 11.3 ± 2.8 kPa, P < .001) and CAP (355 [298–400] vs. 296 [255–352] dB/m, P < .001). Total bilirubin, INR, and creatinine were unchanged (data not shown).

Overall, fifteen patients among twenty-six (15/26) had a regression of fibrosis stage as assessed by liver stiffness whereas eleven patients remained at the same liver fibrosis stage (Figure 1), although they also displayed a reduction of liver stiffness. Eleven patients among eighteen (11/18) passed from F3 to F2 (P < .001) and 4/8 moved from F4 to F3 (P < .001). Almost all patients that experienced a weight loss >10% obtained a regression of fibrosis stage (Figure 1).

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