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19-02-2018

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

Auteurs: 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. Younossi

Gepubliceerd in: Quality of Life Research | Uitgave 6/2018

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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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Metagegevens
Titel
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
Auteurs
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. Younossi
Publicatiedatum
19-02-2018
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 6/2018
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-018-1813-8