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.
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”.
Regarding the results, Ian Crosbie, Chief Executive Officer of Sequana Medical comented: “We are very pleased that these results clearly demonstrate that the alfapump® delivers better health-related quality of life to refractory ascites patients as compared to those treated with large volume paracentesis.” Crosbie adds, “Improving the health-related 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.”
About Refractory Ascites (RA): Accumulation of ascites is a common complication of cirrhosis and one of the leading reasons for hospital admission. The number of patients with cirrhosis, and therefore ascites is predicted to grow significantly, with much of the growth due to the increasing prevalence of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).
Approximately 60% of cirrhotic patients develop ascites within 10 years of diagnosis. An estimated 10% of patients with ascites develop refractory ascites, where the ascites cannot be treated with diuretics or restriction of dietary sodium. The most frequent treatment for RA patients is paracentesis, a lengthy, invasive and painful procedure that can require weekly hospital visits for drainage of excess fluid and is associated with poor quality-of-life. This often involves the drainage of over 5 litres of fluid and is termed large volume paracentesis.
Sequana Medical’s alfapump® is a fully implantable, programmable, transcutaneously-charged, battery-powered pump for the management of refractory ascites. By moving ascites to the bladder, the body can eliminate it naturally through urination. The alfapump® prevents fluid build-up and its’ possible complications, improving patient quality of life and nutrition, and potentially reducing hospital visits and healthcare costs. The alfapump® DirectLink Technology allows clinicians to receive pump performance information and more effectively manage patients treated by the alfapump®.
Over 600 alfapump® systems have been implanted and the product is currently commercially available in Europe.