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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

Stepanova, M; Nader, F; Bureau, C; Adebayo, D; Elkrief, L; Valla, D; Peck-Radosavljevic, M; ... Younossi, ZM; + view all (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. Quality of Life Research , 27 (6) , Article 1573-2649. doi.org/10.1007/s11136-018-1813-8. Green open access

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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.

Type: Article
Title: 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
Open access status: An open access version is available from UCL Discovery
DOI: doi.org/10.1007/s11136-018-1813-8
Publisher version: https://link.springer.com/journal/11136
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Cirrhosis, decompensation, MELD, alcoholic liver disease.
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inst for Liver and Digestive Hlth
URI: https://discovery.ucl.ac.uk/id/eprint/10043616
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