Patients with refractory ascites treated with alfapump® system have better health-related quality of life as compared to those treated with large volume paracentesis: the results of a multicenter randomized controlled study

Abstract

Background

Refractory ascites (RA) is a complication of cirrhosis which is treated with large volume paracentesis (LVP) as the standard of care. Alfapump® system is a fully implantable pump system which reduces the need for LVP. The aim was to assess health-related quality of life (HRQL) in patients treated with alfapump® versus LVP.

Methods

The data were collected in a multicenter open-label randomized controlled trial (clinicaltrials.gov #NCT01528410). Subjects with cirrhosis Child–Pugh class B or C accompanied by RA were randomized to receive alfapump® or LVP. The SF-36v2 and CLDQ scores were compared between the two treatment arms at screening and monthly during treatment.

Results

Of 60 subjects randomized, HRQL data were available for 58 (N = 27 received alfapump® and N = 31 received LVP only). At baseline, no differences were seen between the treatment arms (all p > 0.05): age 61.9 ± 8.4, 79.3% male, MELD scores 11.7 ± 3.3, 85.2% Child–Pugh class B, 70.7% had alcoholic cirrhosis. The mean number of LVP events/subject was lower in alfapump® than LVP (1.1 vs. 8.6, p < 0.001). The HRQL scores showed a moderate improvement from the baseline levels in subjects treated with alfapump® (p < 0.05 for abdominal and activity scores of CLDQ) but not with LVP (all one-sided p > 0.05) in the first 3 months. Multivariate analysis showed that treatment with alfapump® was independently associated with better HRQL at 3 months (total CLDQ score: beta = 0.67 ± 0.33, p = 0.05).

Conclusion

As compared to LVP, the use of alfapump® system is associated with both a reduction in the number of LVP events and improvement of health-related quality of life.

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Abbreviations

TIPSS:

Transjugular intra-hepatic portosystemic shunt

RA:

Refractory ascites

LVP:

Large volume paracentesis

HRQL:

Health-related quality of life

alfapump® system:

Automated low-flow ascites pump system

BMI:

Body mass index

SF-36v2:

Short form-36 version 2

CLDQ:

Chronic Liver Disease Questionnaire

PF:

Physical functioning

RP:

Role physical

BP:

Bodily pain

GH:

General health

VT:

Vitality

SF:

Social functioning

RE:

Role emotional

MH:

Mental health

PCS:

Physical component summary

MCS:

Mental component summary

CLD:

Chronic liver disease

CPT:

Child–Pugh–Turcotte

MELD:

Model for end-stage liver disease

ALD:

Alcoholic liver disease

NASH:

Non-alcoholic steatohepatitis

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Funding

This study was funded by Sequana Medical.

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Correspondence to Zobair M. Younossi.

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Conflict of interest

ZMY is a consultant or advisory board of Abbvie, Intercept, Gilead Sciences, Salix, GSK, BMS, Allergan, Sanofi, and Novo Nordisk. RJ has research collaborations with Ocera, and Yaqrit, consults for Ocera and Yaqrit, and has received speaking and consultation fees from Sequana. RJ is the founder of Yaqrit Limited, which is developing UCL inventions for treatment of patients with cirrhosis. LE had received funding from Sequana for reporting of the data into the CRF for this study. DV received an honorarium from Sequana Medical for this clinical study, is a consultant on the Liver Safety Committee of Laboratoires Servier, and has provided teaching services for Gilead Sciences. PA is a member of the Sequana Medical AG Advisory Board, the LAT Pharma LLC Advisory Board, and the Gilead Advisory Board in Italy. Other co-authors have indicated that they have no potential conflicts of interest to disclose.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Stepanova, M., Nader, F., Bureau, C. et al. Patients with refractory ascites treated with alfapump® system have better health-related quality of life as compared to those treated with large volume paracentesis: the results of a multicenter randomized controlled study. Qual Life Res 27, 1513–1520 (2018). https://doi.org/10.1007/s11136-018-1813-8

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Keywords

  • Cirrhosis
  • Decompensation
  • MELD
  • Alcoholic liver disease