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

Florence Wong, Emily Bendel, Kenneth Sniderman, Todd Frederick, Ziv J Haskal, Arun Sanyal, Sumeet K Asrani, Jeroen Capel, Patrick S Kamath, Florence Wong, Emily Bendel, Kenneth Sniderman, Todd Frederick, Ziv J Haskal, Arun Sanyal, Sumeet K Asrani, Jeroen Capel, Patrick S Kamath

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.

Trial registration: ClinicalTrials.gov NCT02400164.

Copyright © 2020 The Authors. Liver Transplantation published by Wiley Periodicals, Inc., on behalf of American Association for the Study of Liver Diseases.

Figures

Figure 1
Figure 1
Patient disposition.
Figure 2
Figure 2
(A) The number of LVPs/patient/month comparing the period in the 3 months prior to alfapump insertion versus the postinsertion period. Data are shown as mean ± SD. (B) The number of patients who needed various volumes of paracentesis by 3 and 12 months. Please note that patients who died and patients who had early explants due to SAEs were not counted as responders.
Figure 3
Figure 3
Change in QoL as measured by (A) CLDQ score and (B) Ascites Q score in the study patients. Data are shown as mean ± SD. For Ascites Q, a lower score means improvement; for CLDQ, a higher score means improvement.
Figure 4
Figure 4
The overall survival for up to 12 months after enrollment in the study. Last contact is indicated by study withdrawal, death, or the end of the study.
Figure 5
Figure 5
Prealbumin levels in the study patients. Data are shown as mean ± SD.

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