Sequana Medical AG (“Sequana Medical”), a commercial stage medical device company and an innovator in the management of liver disease, announces the publication of a multicentre, randomized controlled study in Quality of Life Research (https://link.springer.com/journal/11136).

The study demonstrated that patients with refractory ascites treated with alfapump® system have better health-related quality of life as compared to those treated with large volume paracentesis.

In this multicentre, open-label randomized controlled trial, subjects were randomised to receive the alfapump® (AP) or large volume Paracentesis (LVP) (27 AP, 31 SoC). The SF-36v2 and CLDQ scores were compared between the two treatment arms at screening and monthly during treatment

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, in 6 months after treatment; p < 0.001). The health-related quality of life (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. Subjects with refractory ascites who were treated with LVP continued to worsen their HRQL and experience no HRQL benefit. In contrast, subjects with refractory ascites who were treated with alfapump® system did experience improvement of HRQL as early as 1 month after treatment initiation. In fact, this improvement continued with longer follow-up of those subjects, and clinically meaningful HRQL superiority was noted in multiple domains related to bodily pain, other systemic symptoms, and fatigue. It is also important to note that the superiority of HRQL in patients treated with alfapump® remained significant even after controlling for other known predictors of HRQL scores. This supports HRQL-related benefits of alfapump® system over LVP.

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.

“These results are very encouraging”, commented Professor Rajiv Jalan, Professor of Hepatology at the UCL Medical School, and investigator of the alfapump® randomized controlled trial. “Refractory ascites has a marked impact on these patient’s quality of life and the alfapump® demonstrated it provides a clinically meaningful improvement of HRQL. This benefit is of particular importance as a poor physical component of QoL in patients with refractory ascites is associated with increased mortality”.

“We are very pleased that these results clearly demonstrate that the alfapump® delivers better healthrelated quality of life to refractory ascites patients as compared to those treated with large volume paracentesis” said Ian Crosbie, Chief Executive Officer of Sequana Medical. “Improving the healthrelated quality of life is one of the key clinical objectives in the management of these patients. We believe that this benefit combined with the significant reduction in the number of LVP / subject demonstrates that the alfapump® is an important treatment option for the treatment of refractory ascites - a market that is forecast to grow significantly due to NAFLD and NASH."