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 in: Quality of life research Vol. 27; no. 6; pp. 1513 - 1520
• Main Authors: Stepanova, Maria, Nader, Fatema, Bureau, Christophe, Adebayo, Danielle, Elkrief, Laure, Valla, Dominique, Peck-Radosavljevic, Markus, McCune, Anne, Vargas, Victor, Simon-Talero, Macarena, Cordoba, Juan, Angeli, Paolo, Rossi, Silvia, MacDonald, Stewart, Capel, Jeroen, Jalan, Rajiv, Younossi, Zobair M.
• Format: Journal Article
• Language: English
• Published: Cham Springer 01.06.2018; Springer International Publishing; Springer Nature B.V
• Subjects: Ascites; CLINICAL AND POLICY APPLICATIONS; Liver cirrhosis; Medical equipment; Medical treatment; Medicine; Medicine & Public Health; Multivariate analysis; Public Health; Quality of life; Quality of Life Research; Sociology; Cirrhosis; MELD; Decompensation; Alcoholic liver disease
• ISSN: 0962-9343; 1573-2649; 1573-2649
• DOI: 10.1007/s11136-018-1813-8

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 class 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.