Improvement in Quality of Life and Decrease in Large‐Volume Paracentesis Requirements With the Automated Low‐Flow Ascites Pump

Abstract

The automated low-flow ascites pump (alfapump) is an implantable device that drains ascites directly into the urinary bladder. We studied its safety (absence of serious complications) and efficacy (decreased large-volume paracentesis [LVP] requirement and improved quality of life [QoL]) in the management of ascites in a cohort of North American patients with cirrhosis and recurrent ascites ineligible for transjugular intrahepatic portosystemic shunt (TIPS). QoL was measured by the Chronic Liver Disease Questionnaire (CLDQ) and Ascites Questionnaire (Ascites Q). Following alfapump implantation, patients were monitored for ascites control, laboratory abnormalities, QoL, adverse events, and survival at 12 months. A total of 30 patients (60.0 ± 9.9 years; 57% male; Model for End-Stage Liver Disease score, 11.4 ± 2.7) received an alfapump, mostly by an interventional radiology approach (97%), followed by longterm prophylactic antibiotics. The alfapump removed a mean ascites volume of 230.6 ± 148.9 L/patient at 12 months, dramatically reducing the mean LVP frequency from 2.4 ± 1.4/patient/month before pump implantation to 0.2 ± 0.4/patient/month after pump implantation. All surviving patients had improved QoL (baseline versus 3 months; CLDQ, 3.9 ± 1.21 versus 5.0 ± 1.0; Ascites Q, 51.7 ± 21.9 versus 26.7 ± 18.6; P < 0.001 for both) and a better biochemical index of nutritional status (prealbumin 87.8 ± 37.5 versus 102.9 ± 45.3 mg/L at 3 months; P = 0.04). Bacterial infections (15 events in 13 patients), electrolyte abnormalities (11 events in 6 patients), and renal complications (11 events in 9 patients) were the most common severe adverse events. By 12 months, 4 patients died from complications of cirrhosis. Alfapump insertion may be a definitive treatment for refractory ascites in cirrhosis, especially in patients who are not TIPS candidates.Liver Transplantation 26 651-661 2020 AASLD. standard deviation; TIPS, transjugular intrahepatic portosystemic shunt; UTI, urinary tract infection; WBC, white blood cells.Address reprint requests to Florence Wong, M.B., B.

Improvement in Quality of Life and Decrease in Large‐Volume Paracentesis Requirements With the Automated Low‐Flow Ascites Pump

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We read with great interest the multicenter, openlabel study of the automated low-flow ascites pump (alfapump) system in cirrhosis with recurrent ascites (Multicenter, Open-Label Study of the Automated Low-Flow Asciites Pump [Alfapump] System in Cirrhosis [MOSAIC] study) by Wong et al in which they described the safety and efficacy of the alfapump system for control of refractory ascites in a North American cohort. (1) In this study, the alfapump system, which was inserted by an interventional radiologist using a minimally invasive technique, yielded similar technical success as compared with surgical insertion techniques used in previous studies. They demonstrated that the alfapump system was not only effective in reducing the requirement for large-volume paracentesis (LVP) but also led to significant improvement in quality of life (QoL) of patients with refractory ascites.

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Endpoints and design of clinical trials in patients with decompensated cirrhosis: Position paper of the LiverHope Consortium

“…Although survival is a strong primary endpoint it should probably not be the primary endpoint of choice in these trials. Interventions for the management of refractory ascites may not increase survival, particularly in patients who are not candidates for liver transplantation, but may improve the control of ascites or HRQOL, [88][89][90] which are clinically meaningful endpoints in this population.…”

HEP-Net opinion on the management of ascites and its complications in the setting of decompensated cirrhosis in the resource constrained environment of Pakistan

“…However long term studies with larger patient populations are ongoing which will further establish main concerns about such a system, especially pump dysfunction (pump failure and bladder and peritoneal catheter related problems), infection, ascitic fluid leakage through wounds, bladder perforation and renal impairment. 68 - 73 …”

“…However long term studies with larger patient populations are ongoing which will further establish main concerns about such a system, especially pump dysfunction (pump failure and bladder and peritoneal catheter related problems), infection, ascitic fluid leakage through wounds, bladder perforation and renal impairment. [68][69][70][71][72][73] Recommendations: The incidence of SBP in cirrhotic patients in Pakistan averages 27-38 % of all patients admitted to hospitals, as noted in various studies. [74][75][76][77][78] Up to 10% of asymptomatic patients with cirrhosis presenting for routine outpatient checkups have been found to have SBP.…”