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.
Preview |
Text
Jalan_manuscript_RAandHRQL_revisedfull.pdf - Accepted Version Download (352kB) | Preview |
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 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 |
Archive Staff Only
 |
View Item |
