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Quality of Life Research

, Volume 27, Issue 6, pp 1513–1520 | Cite as

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

  • Maria Stepanova
  • Fatema Nader
  • Christophe Bureau
  • Danielle Adebayo
  • Laure Elkrief
  • Dominique Valla
  • Markus Peck-Radosavljevic
  • Anne McCune
  • Victor Vargas
  • Macarena Simon-Talero
  • Juan Cordoba
  • Paolo Angeli
  • Silvia Rossi
  • Stewart MacDonald
  • Jeroen Capel
  • Rajiv Jalan
  • Zobair M. YounossiEmail author
Article

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.

Keywords

Cirrhosis Decompensation MELD Alcoholic liver disease 

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

Notes

Funding

This study was funded by Sequana Medical.

Compliance with ethical standards

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.

Informed consent

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

Supplementary material

11136_2018_1813_MOESM1_ESM.docx (55 kb)
Supplementary material 1 (DOCX 44 KB)

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Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Maria Stepanova
    • 1
  • Fatema Nader
    • 1
  • Christophe Bureau
    • 2
  • Danielle Adebayo
    • 3
  • Laure Elkrief
    • 4
  • Dominique Valla
    • 4
  • Markus Peck-Radosavljevic
    • 5
  • Anne McCune
    • 6
  • Victor Vargas
    • 7
  • Macarena Simon-Talero
    • 7
  • Juan Cordoba
    • 7
  • Paolo Angeli
    • 8
  • Silvia Rossi
    • 8
  • Stewart MacDonald
    • 3
  • Jeroen Capel
    • 9
  • Rajiv Jalan
    • 3
  • Zobair M. Younossi
    • 10
    • 11
    Email author
  1. 1.Center for Outcomes Research in Liver DiseasesWashingtonUSA
  2. 2.Service d’hépato-gastroentérologieCHU ToulouseToulouseFrance
  3. 3.UCL Institute of Hepatology, Royal Free HospitalUniversity College LondonLondonUK
  4. 4.DHU UNITY, Service d’hépatologie, Hôpital Beaujon, Clichy, and Université Paris Diderot and Inserm U1149ParisFrance
  5. 5.Department of Gastroenterology/Hepatology, Endocrinology and NephrologyKlinikum Klagenfurt am WörtherseeKlagenfurtAustria
  6. 6.Department of HepatologyBristol Royal InfirmaryBristolUK
  7. 7.Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d´Hebron, VHIRUniversitat Autònoma de Barcelona, CIBERehdBarcelonaSpain
  8. 8.Facoltà di Medicina e ChirurgiaUniversità degli Studi di PadovaPadovaItaly
  9. 9.Sequana Medical AGZurichSwitzerland
  10. 10.Department of MedicineInova Fairfax HospitalFalls ChurchUSA
  11. 11.Betty and Guy Beatty Center for Integrated Research, Claude Moore Health Education and Research BuildingFalls ChurchUSA

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