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Copyright ©The Author(s) 2022.
World J Hepatol. Jul 27, 2022; 14(7): 1344-1356
Published online Jul 27, 2022. doi: 10.4254/wjh.v14.i7.1344
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 ProspectiveLife 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 inclusion405912 6 moNumber of paracentesis/mo/patient: 3.4 vs 0.24; P < 0.018 (25)5 (12)
Thomas et al[20], 2015Observational ProspectiveNa10Na16 Median: 165 d (maximum: 379 d)Number of paracentesis/mo/patient: 3.4 ± 0.8 vs 0.4 ± 1.0 P < 0.00013 (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: 316112 6 moMedian number of paracentesis on day 28 G1 vs G2: 0.3 vs 1.2; P < 0.001G1 vs G2: 22 vs 13, P = NS3 (11)
Stirnimann et al[18], 2017 Observational ProspectiveInability to use the device 566213 Median: 5.8 mo (maximum: 26 mo)Number of paracentesis/mo/patient: 2.9 ± 1.8 vs 0.3 ± 0.3, P = NA23 (41)9 (16)
Solà et al[19], 2017Observational ProspectiveCreatinine > 176 µmol/L Bilirubin > 85 µmol/L ≥ 2 urinary tract infections or SBP in the 6 mo prior to inclusion HCC outside Milan criteria 105911 12 moNumber of paracentesis/3 mo/patient 7.5 vs 2.4; P = NA5 (50)NA
Solbach et al[17], 2018 RetrospectiveNa215615 NaNumber of paracentesis/wk/patient: 2.3 ± 2.7 vs 0; P = NAMedian survival: 153 d4 (19)
Wong et al[20], 2020Observational ProspectiveMELD 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 m2301 6011 12 moNumber of paracentesis/mo/patient: 2.4 ± 1.4 vs 0.2 ± 0.4; P < 0.054 (13.3)3 (10)
Will et al[24], 2020 Retrospective TIPS vs alfapumpNa405916 Median: 4.7 mo (maximum: 24 mo)Number of paracentesis: no more paracentesis at 6 mo for 43% of patients 24 (60)11 (28)
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], 20134013 episodes, 11 patients106 vs 127 µmol/L at 3 mo (P = NA) 105 µmol/L at 6 mo (P = NA)123
Thomas et al[20], 2015103 episodes168 vs 221 µmol/L at 2 mo (P = NS)NANA
Bureau et al[16], 2017127After day 7: G1 vs G2: 17 vs 11 episodes; P = NSG1 vs G2, at 3 mo: Increase of 18.1 vs 8.1 µmol/L (P = NS)NANA
Stirnimann et al[18], 2017 56NAIncrease of 46 µmol/L at 3 mo (P = NA)51
Solà et al, 20171018 episodes, 14 after day 7 in 7 patients 96 vs 105 µmol/L at 12 mo (P = NS)38
Solbach et al[17], 2018210140 vs 168 µmol/L at 3 mo (P = NS)114
Wong et al[20], 20203011 episodes after day 7 in 9 patients93 vs 107 µmol/L at 12 mo (P = NA)13
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], 201340592Infection: 2 Wound: 213/NA
Thomas et al[20], 2015100Kinking: 11Infection: 1 Wound: 21/0
Bureau et al[16], 201727231233/4
Stirnimann et al[18], 2017 56Blockage: 13 Displacement: 2 Disconnection: 1 Twist: 2Blockage: 1 Migration: 1Clogging: 2 Humidity: 2 Communication: 4 Faulty sensor: 3Infection: 2 Wound: 217/11
Solà et al[19], 201710Migration: 2 Blockage: 12Charging problem: 2 Transient blockage:2 12/1
Karkhanis et al[14], 201730Migration: 112
Solbach et al[17], 201821Obstructions: 6Dislocations: 5444/2
Wong et al[20], 2020301313410/9
Will et al[24], 202040NAObstructions: 9NANA12/40