SpringerLink
Log in

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

  • Published:
Quality of Life Research Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Subscribe and save

Springer+ Basic
EUR 32.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or Ebook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

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

References

  1. Moore, C. M., & Van Thiel, D. H. (2013). Cirrhotic ascites review: Pathophysiology, diagnosis and management. World Journal of Hepatology, 5(5), 251–263.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Planas, R., Montoliu, S., Ballesté, B., Rivera, M., Miquel, M., Masnou, H., et al. (2006). Natural history of patients hospitalized for management of cirrhotic ascites. Clinical Gastroenterology and Hepatology, 4(11), 1385–1394.

    Article  PubMed  Google Scholar 

  3. Runyon, B. A., & AASLD Practice Guidelines Committee. (2009). Management of adult patients with ascites due to cirrhosis: An update. Hepatology, 49(6), 2087–2107.

    Article  PubMed  Google Scholar 

  4. European Association for the Study of the Liver. (2010). EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. Journal of Hepatology, 53(3):397–417.

    Article  Google Scholar 

  5. Barsuk, J. H., Cohen, E. R., Feinglass, J., McGaghie, W. C., & Wayne, D. B. (2013). Clinical outcomes after bedside and interventional radiology paracentesis procedures. American Journal of Medicine, 126(4), 349–3 56.

    Article  PubMed  Google Scholar 

  6. Barsuk, J. H., Feinglass, J., Kozmic, S. E., Hohmann, S. F., Ganger, D., & Wayne, D. B. (2014). Specialties performing paracentesis procedures at university hospitals: Implications for training and certification. Journal of Hospital Medicine, 9(3), 162–168. https://doi.org/10.1002/jhm.2153.

    Article  PubMed  Google Scholar 

  7. Smith, M., & Durham, J. (2016). Evolving indications for TIPS. Techniques in Vascular and Interventional Radiology, 19(1), 36–41.

    Article  PubMed  Google Scholar 

  8. Copelan, A., Kapoor, B., & Sands, M. (2014). Transjugular intrahepatic portosystemic shunt: Indications, contraindications, and patient work-up. Seminars Interventional Radiology, 31(3), 235–242.

    Article  Google Scholar 

  9. American College of Radiology, Society for Pediatric Radiology, and Society for Interventional Radiology. (2014). ACR-SIR-SPR practice parameter for the creation of a transjugular intrahepatic portosystemic shunt (TIPS), Amended 2014 (Resolution 39). Practice parameters and technical standards, pp. 1–22.

  10. Teiusanu, A., Andrei, M., Arbanas, T., Nicolaie, T., & Diculescu, M. (2012). Nutritional status in cirrhotic patients. Maedica (Buchar), 7(4), 284–289.

    Google Scholar 

  11. Sorrentino, P., Castaldo, G., Tarantino, L., Bracigliano, A., Perrella, A., Perrella, O., et al. (2012). Preservation of nutritional-status in patients with refractory ascites due to hepatic cirrhosis who are undergoing repeated paracentesis. Journal of Gastroenterology and Hepatology, 27(4), 813–822.

    Article  PubMed  Google Scholar 

  12. Younossi, Z. M., Boparai, N., McCormick, M., Price, L. L., & Guyatt, G. (2001). Assessment of utilities and health-related quality of life in patients with chronic liver disease. American Journal of Gastroenterology, 96(2), 579–583.

    Article  PubMed  CAS  Google Scholar 

  13. Solà, E., Watson, H., Graupera, I., Turón, F., Barreto, R., Rodríguez, E., et al. (2012). Factors related to quality of life in patients with cirrhosis and ascites: Relevance of serum sodium concentration and leg edema. Journal of Hepatology, 57(6), 1199 – 206.

    Article  PubMed  CAS  Google Scholar 

  14. Orr, J. G., Homer, T., Ternent, L., Newton, J., McNeil, C. J., Hudson, M., et al. (2014). Health related quality of life in people with advanced chronic liver disease. Journal of Hepatology, 61(5), 1158–1165.

    Article  PubMed  Google Scholar 

  15. Bhanji, R. A., Carey, E. J., & Watt, K. D. (2017). Review article: Maximising quality of life while aspiring for quantity of life in end-stage liver disease. Alimentary Pharmacology and Therapy, 46(1), 16–25.

    Article  CAS  Google Scholar 

  16. Jara, M., Bednarsch, J., Malinowski, M., Lüttgert, K., Orr, J., Puhl, G., Seehofer, D., Neuhaus, P., & Stockmann, M. (2014). Predictors of quality of life in patients evaluated for liver transplantation. Clinical Transplantation, 28(12), 1331–1338.

    Article  PubMed  Google Scholar 

  17. Bureau, C., Adebayo, D., Chalret de Rieu, M., Elkrief, L., Valla, D., Peck-Radosavljevic, M., et al. (2017). Alfapump® system versus large volume paracentesis for refractory ascites: A multicenter randomized controlled study. Journal of Hepatology, https://doi.org/10.1016/j.jhep.2017.06.010.

    Article  PubMed  Google Scholar 

  18. Moore, K. P., & Aithal, G. P. (2006). Guidelines on the management of ascites in cirrhosis. Gut, 55(Suppl 6), vi1–12.

    Google Scholar 

  19. Ware, J. E. Jr., & Sherbourne, C. D. (1992). The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Medical Care, 30(6), 473–483.

    Article  PubMed  Google Scholar 

  20. Kharroubi, S. A., Brazier, J. E., Roberts, J., O’Hagan, A. (2007). Modelling SF-6D health state preference data using a nonparametric Bayesian method. Journal of Health Economics, 26(3), 597–612.

    Article  PubMed  Google Scholar 

  21. Younossi, Z. M., Stepanova, M., & Henry, L. (2016). Performance and validation of Chronic Liver Disease Questionnaire-hepatitis C version (CLDQ-HCV) in clinical trials of patients with chronic hepatitis C. Value Health, 19(5), 544–551.

    Article  PubMed  Google Scholar 

  22. Ware, J. E., Kosinski, M., Bjorner, J. B., Turner-Bowker, D. M., Gandek, B., & Maruish, M. E. (2007). User’s manual for the SF-36v2 health survey (2nd ed.). Lincoln, RI: Quality Metric Incorporated.

    Google Scholar 

  23. Fryback, D. G., Dunham, N. C., Palta, M., Hanmer, J., Buechner, J., Cherepanov, D., et al. (2007). US norms for six generic health-related quality-of-life indexes from the National Health Measurement study. Medical Care, 45(12), 1162–1170.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Younossi, Z. M., Guyatt, G., Kiwi, M., Boparai, N., & King, D. (1999). Development of a disease specific questionnaire to measure health related quality of life in patients with chronic liver disease. Gut, 45(2), 295–300.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  25. Sayiner, M., Stepanova, M., Pham, H., Noor, B., Walters, M., & Younossi, Z. M. (2016). Assessment of health utilities and quality of life in patients with non-alcoholic fatty liver disease. BMJ Open Gastroenterology, 3(1), e000106.

    Article  PubMed  PubMed Central  Google Scholar 

  26. Campbell, M. S., Brensinger, C. M., Sanyal, A. J., Gennings, C., Wong, F., Kowdley, K. V., et al. (2005). Quality of life in refractory ascites: transjugular intrahepatic portal-systemic shunting versus medical therapy. Hepatology, 42(3), 635–640.

    Article  PubMed  Google Scholar 

  27. Afendy, A., Kallman, J. B., Stepanova, M., Younoszai, Z., Aquino, R. D., Bianchi, G., Marchesini, G., & Younossi, Z. M. (2009). Predictors of health-related quality of life in patients with chronic liver disease. Alimentary Pharmacology Therapy, 30(5), 469–476.

    Article  CAS  Google Scholar 

  28. Adebayo, D., Bureau, C., Valla, D., Peck-Radosavljevic, M., McCune, A., Vargas, V., et al. (2015). Alfapump® system versus large volume paracentesis in the treatment of refractory ascites. A multicenter randomised controlled study. Journalof Hepatology, 62(Suppl 2), S849–S850.

    Article  Google Scholar 

  29. Paparrigopoulos, T., Tzavellas, E., Karaiskos, D., Liappas, I. (2007). Should impaired liver function be held responsible for cognitive impairment and poor health-related quality of life in alcoholic cirrhosis? Hepatology, 46(3):950; author reply 951.

    Article  PubMed  Google Scholar 

  30. Imtiaz, S., Loheswaran, G., Le Foll, B., & Rehm, J. (2017). Longitudinal alcohol consumption patterns and health-related quality of life: Results from the National Epidemiologic Survey on alcohol and related conditions. Drug and Alcohol Review, https://doi.org/10.1111/dar.12503.

    Article  PubMed  Google Scholar 

  31. Spiegel, B. M., Younossi, Z. M., Hays, R. D., Revicki, D., Robbins, S., & Kanwal, F. (2005). Impact of hepatitis C on health related quality of life: A systematic review and quantitative assessment. Hepatology, 41(4), 790–800.

    Article  PubMed  Google Scholar 

  32. Walters, S. J., & Brazier, J. E. (2003). What is the relationship between the minimally important difference and health state utility values? The case of the SF-6D. Health and Quality Life Outcomes, 1(1), 4.

    Article  Google Scholar 

  33. Loria, A., Escheik, C., Gerber, N. L., & Younossi, Z. M. (2013). Quality of life in cirrhosis. Current Gastroenterology Reports, 15(1), 301. https://doi.org/10.1007/s11894-012-0301-5. Review. PubMed PMID: 23250701.

    Article  PubMed  Google Scholar 

Download references

Funding

This study was funded by Sequana Medical.

Author information

Authors and Affiliations

  1. Center for Outcomes Research in Liver Diseases, Washington, DC, USA

    Maria Stepanova & Fatema Nader

  2. Service d’hépato-gastroentérologie, CHU Toulouse, Toulouse, France

    Christophe Bureau

  3. UCL Institute of Hepatology, Royal Free Hospital, University College London, London, UK

    Danielle Adebayo, Stewart MacDonald & Rajiv Jalan

  4. DHU UNITY, Service d’hépatologie, Hôpital Beaujon, Clichy, and Université Paris Diderot and Inserm U1149, Paris, France

    Laure Elkrief & Dominique Valla

  5. Department of Gastroenterology/Hepatology, Endocrinology and Nephrology, Klinikum Klagenfurt am Wörthersee, Klagenfurt, Austria

    Markus Peck-Radosavljevic

  6. Department of Hepatology, Bristol Royal Infirmary, Bristol, UK

    Anne McCune

  7. Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d´Hebron, VHIR, Universitat Autònoma de Barcelona, CIBERehd, Barcelona, Spain

    Victor Vargas, Macarena Simon-Talero & Juan Cordoba

  8. Facoltà di Medicina e Chirurgia, Università degli Studi di Padova, Padova, Italy

    Paolo Angeli & Silvia Rossi

  9. Sequana Medical AG, Zurich, Switzerland

    Jeroen Capel

  10. Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, USA

    Zobair M. Younossi

  11. Betty and Guy Beatty Center for Integrated Research, Claude Moore Health Education and Research Building, 3300 Gallows Road, Falls Church, VA, 22042, USA

    Zobair M. Younossi

Authors
  1. Maria Stepanova
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Fatema Nader
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Christophe Bureau
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Danielle Adebayo
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Laure Elkrief
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Dominique Valla
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Markus Peck-Radosavljevic
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Anne McCune
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Victor Vargas
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Macarena Simon-Talero
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Juan Cordoba
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Paolo Angeli
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Silvia Rossi
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Stewart MacDonald
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. Jeroen Capel
    View author publications

    You can also search for this author in PubMed Google Scholar

  16. Rajiv Jalan
    View author publications

    You can also search for this author in PubMed Google Scholar

  17. Zobair M. Younossi
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Zobair M. Younossi.

Ethics declarations

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 develo** 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.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary material 1 (DOCX 44 KB)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

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

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11136-018-1813-8

Keywords

Search

Navigation