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.

Table 2 General complications after implantation of alfapump^®: Acute kidney injury and peritoneal and urinary tract infections

Ref.	Patients (n)	AKI occurrence during follow-up	Variation in creatinine levels before vs after implantation	Peritoneal infections (n episodes)	Urinary tract infections (n episodes)
Bellot et al[13], 2013	40	13 episodes, 11 patients	106 vs 127 µmol/L at 3 mo (P = NA) 105 µmol/L at 6 mo (P = NA)	12	3
Thomas et al[20], 2015	10	3 episodes	168 vs 221 µmol/L at 2 mo (P = NS)	NA	NA
Bureau et al[16], 20171	27	After day 7: G1 vs G2: 17 vs 11 episodes; P = NS	G1 vs G2, at 3 mo: Increase of 18.1 vs 8.1 µmol/L (P = NS)	NA	NA
Stirnimann et al[18], 2017	56	NA	Increase of 46 µmol/L at 3 mo (P = NA)	5	1
Solà et al, 2017	10	18 episodes, 14 after day 7 in 7 patients	96 vs 105 µmol/L at 12 mo (P = NS)	3	8
Solbach et al[17], 2018	21	0	140 vs 168 µmol/L at 3 mo (P = NS)	11	4
Wong et al[20], 2020	30	11 episodes after day 7 in 9 patients	93 vs 107 µmol/L at 12 mo (P = NA)	1	3

¹In this randomized controlled study, G1 and G2 correspond to alfapump^® and iterative paracentesis groups, respectively. AKI: Acute kidney injury; NA: Not available; NS: Not significant.

Table 3 Device-related complications after alfapump^® implantation

Ref.	Patients (n)	Peritoneal catheter dysfunction (n patients)	Bladder catheter dysfunction (n patients)	Pump dysfunction (n patients)	Pump pocket complication (n patients)	Explanted/replaced pumps
Bellot et al[15], 2013	40	5	9	2	Infection: 2 Wound: 2	13/NA
Thomas et al[20], 2015	10	0	Kinking: 1	1	Infection: 1 Wound: 2	1/0
Bureau et al[16], 2017	27	2	3	12	3	3/4
Stirnimann et al[18], 2017	56	Blockage: 13 Displacement: 2 Disconnection: 1 Twist: 2	Blockage: 1 Migration: 1	Clogging: 2 Humidity: 2 Communication: 4 Faulty sensor: 3	Infection: 2 Wound: 2	17/11
Solà et al[19], 2017	10	Migration: 2 Blockage: 1	2	Charging problem: 2 Transient blockage:2	1	2/1
Karkhanis et al[14], 2017	3	0	Migration: 1	1	2
Solbach et al[17], 2018	21	Obstructions: 6	Dislocations: 5	4	4	4/2
Wong et al[20], 2020	30	13	1	3	4	10/9
Will et al[24], 2020	40	NA	Obstructions: 9	NA	NA	12/40