Liver Fibrosis stage at baseline predicts outcome of metabolic surgery

Background:

Metabolic surgery is becomming increasingly relevant for the treatment of Non-alcoholic fatty liver disease (NAFLD). However, it might carry an increased risk for liver decompensation and mortality in cirrhotic patients.

Methods:

In a randomized controlled trial, baseline intraoperative needle liver biopsy was performed in 46 patients who underwent one-anastomosis gastric bypass (OAGB). Patients were followed for 12 months for non-invasive Fibroscan™ (FS) measures (M and XL probe) for the non-invasive detection of the presence of histologically advanced fibrosis and response to metabolic surgery as well as metabolic signatures and laboratory improvements. Univariate and multivariable analysis were used to test the predictive relevance of data assessed.

Results:

78% of subjects were female, mean age was 42 (SD 12) years with a BMI of 44 (4)kg/m², a waist circumference of 128 (11)cm, and a HOMA index of 6.96 (5.81). 26% suffered from diabetes, 50% from hypertension, and 26% from hyperlipidemia. 72% demonstrated NASH, 11% simple steatosis, and 17% normal liver morphology. 30% showed significant fibrosis (F≥2), 9% advanced fibrosis (F3) and 4% cirrhosis (F4). (I) Metabolic surgery significantly improved BMI, waist circumference, HOMA Index, liver tests, and liver stiffness. Importantly, patients with F< 2 responded better. (adjusted for baseline value, age, sex, and diabetes mellitus). Of note, the groups (F< 2 vs. F> 3) did not differ at baseline. (Table 1) (II) FS correlated significantly (r = 0.516; p < 0.001) with histological fibrosis readings and showed an AUC of 0.738 (p = 0.009) to predict F≥2 and an even better AUC 0.815 (p = 0.015) for F> 3. (III) Importantly, we observed a high variance in FS measurements (SD at baseline: 3.1 kPa, 1 months: 3.1 kPa, 3 months: 4 kPa, 6 months: 2.1 kPa, 12 months: 2.4 kPa,) before weight loss. (Fig. 1)

Tab. 1

		Baseline				3 months				6 months				12 months				p value* group	p value* time	p value* group* time
		mean	SD	N	P value#	mean	SD	N	p value*	mean	SD	N	p value*	mean	SD	N	p value*
Body mass index (kg/m2)	FO-1	44,0	4,6	32	0,673	36,2	3,7	28	0,399	31,7	3,6	28	0,004	27,1	3,3	23	< 0,001	0,004	< 0,001	< 0,001
	F ≥2	43,5	4,0	14		36.3	4,2	13		33,1	4,3	13		30,4	4,0	11
Waist circumference (cm)	FO-1	126,1	11,7	31	0,065	111,7	11,1	28	0,559	100,2	9,4	28	0,046	91,3	9,2	23	< 0,001	0,002	< 0,001	0,001
	F ≥2	131,6	7,3	14		114,7	4,8	13		105,8	6,3	12		104,6	7,9	11
Homa Index (HOMA2-IR)	FO-1	4,94	2,50	32	< 0,001	2,42	2,08	27	0,102	1,74	1,05	28	0,005	1,10	0,51	24	0,147	< 0,001	< 0,001	0,014
	F ≥2	11,59	8,29	14		4,39	2,70	13		3,99	2,40	13		2,97	1,61	11
ASAT (U/L)	FO-1	25,3	9,3	32	0,035	26,8	7,7	27	0,936	27,3	8,4	28	0,066	29,0	12,3	24	0,092	0,462	< 0,001	0,075
	F ≥2	34,4	20,8	14		31,8	16,6	13		24,9	6,2	13		27,3	8,1	11
ALAT (U/L)	FO-1	32,7	18,1	32	0,022	32,5	13,2	27	0,771	32,1	15,5	28	0,205	35,0	20,1	24	0,387	0,905	< 0,001	0,254
	F ≥2	46,3	26,2	14		38,8	18,9	13		27,9	7,8	13		33,4	10,8	11
Gamma-GT (U/L)	FO-1	32,3	25,5	32	0,005	18,4	10,0	27	0,115	17,5	10,5	28	0,263	15,3	7,6	24	0,160	0,480	0,001	0,145
	F ≥2	65,8	62,5	14		61,4	90,9	13		56,6	86,0	13		45,8	42,7	11
Liver stiffness measurement (LSM; kPa)	FO-1	6,0	2,4	30	0,008	6,0	1,7	25	0,710	6,0	1,6	22	0,072	5,1	1,4	12	0,235	0,335	0,011	0,219
	F ≥2	8,7	3,8	12		8,5	6,4	12		7,1	2,9	9		7,4	3,7	5
# T-Test/Mann-Whitney-U-Test or chi2-Test (FO-1 vs. F ≥2) *linear mixed model; adjusted for baseline value, fibrosis stage, age, sex, or diabetes mellitus

Fig. 1

Conclusion:

Fibroscan™ is an important tool to preoperatively select patients for optimal outcome of metabolic surgery.