Alfapump® implantable device in management of refractory ascites: An update

Table 1 Characteristics and results of main studies evaluating alfapump^®

Ref.	Study design	Main exclusion criteria	N patients	Mean age (yr)	MELD score2	Follow-up	Efficacy of the device	Mortality during follow-up, patients, n (%)	Liver transplantation after pump implantation (%)
Bellot et al[15], 2013	Observational Prospective	Life expectancy < 6 mo Creatinine > 176 µmol/L in the 7 d prior to inclusion Bilirubin > 85 µmol/L Malignancy (including HCC) HE and/or GI bleeding related to portal hypertension in the 2 wk prior to inclusion	40	59	12	6 mo	Number of paracentesis/mo/patient: 3.4 vs 0.24; P < 0.01	8 (25)	5 (12)
Thomas et al[20], 2015	Observational Prospective	Na	10	Na	16	Median: 165 d (maximum: 379 d)	Number of paracentesis/mo/patient: 3.4 ± 0.8 vs 0.4 ± 1.0 P < 0.0001	3 (30)	1 (10)
Bureau et al[16], 2017	RCT: alfapump (G1) vs iterative paracentesis (G2)	Creatinine > 176 µmol/L HCC outside Milan criteria Inability to use the device	G1: 27 G2: 31	61	12	6 mo	Median number of paracentesis on day 28 G1 vs G2: 0.3 vs 1.2; P < 0.001	G1 vs G2: 22 vs 13, P = NS	3 (11)
Stirnimann et al[18], 2017	Observational Prospective	Inability to use the device	56	62	13	Median: 5.8 mo (maximum: 26 mo)	Number of paracentesis/mo/patient: 2.9 ± 1.8 vs 0.3 ± 0.3, P = NA	23 (41)	9 (16)
Solà et al[19], 2017	Observational Prospective	Creatinine > 176 µmol/L Bilirubin > 85 µmol/L ≥ 2 urinary tract infections or SBP in the 6 mo prior to inclusion HCC outside Milan criteria	10	59	11	12 mo	Number of paracentesis/3 mo/patient 7.5 vs 2.4; P = NA	5 (50)	NA
Solbach et al[17], 2018	Retrospective	Na	21	56	15	Na	Number of paracentesis/wk/patient: 2.3 ± 2.7 vs 0; P = NA	Median survival: 153 d	4 (19)
Wong et al[20], 2020	Observational Prospective	MELD score > 21 HE stage > II in the 15 d prior to inclusion > 2 systemic or local infections in the 6 mo prior to inclusion Bilirubin > 85 μmol/L Creatinine > 132 μmol/L GFR < 30 mL/min/1.73 m2	301	60	11	12 mo	Number of paracentesis/mo/patient: 2.4 ± 1.4 vs 0.2 ± 0.4; P < 0.05	4 (13.3)	3 (10)
Will et al[24], 2020	Retrospective TIPS vs alfapump	Na	40	59	16	Median: 4.7 mo (maximum: 24 mo)	Number of paracentesis: no more paracentesis at 6 mo for 43% of patients	24 (60)	11 (28)

¹Implant through interventional radiology (n = 29) or surgery (n = 1).

²Median values (ref. Bellot et al[15], Bureau et al[16], Stirnimann et al[18]) or mean values (ref. Thomas et al[20], Solbach et al[17], Wong et al[12], Will et al[24]) of the MELD score on the day of implantation. Main exclusion criteria without listing usual absolute contraindications. GFR: Glomerular filtration rate; GI: Gastrointestinal; HCC: Hepatocellular carcinoma; HE: Hepatic encephalopathy; MELD: Model for End-stage Liver Disease; NA: Not available; NS: Not significant; RCT: Randomized control trial; SBP: Spontaneous bacterial peritonitis; TIPS: Transjugular intrahepatic portosystemic shunt.