Disclaimer
The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com.
The DSR therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed.
The DSR therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR therapy and ongoing investigations with the alfapump® system in Europe.
Physicians will attempt to minimize the amount of fluid within the intraperitoneal cavity without intravascular volume depletion. Treatment of ascites usually improves quality of life by decreasing abdominal discomfort or dyspnea to name a few.
As per guidelines, ascites management should include minimizing consumption of alcohol and dietary sodium. Depending on the degree of severity, management of ascites includes oral diuretics, therapeutic (large-volume) paracentesis, transjugular intrahepatic portosystemic shunt (TIPS), and liver transplantation.
The standard of care for refractory ascites is large volume paracentesis (LVP) with albumin infusion to decrease the risk of paracentesis-induced circulatory dysfunction. Although LVP is generally considered safe, it is a painful and burdensome procedure which only provides short-term symptomatic relief as it needs to be repeated when the ascites re-accumulates.
In some patients with liver refractory ascites, a therapeutic alternative to repeated LVPs is the use of TIPS. TIPS is a shunt to re-route a significant proportion of the blood flow around the damaged liver into the main blood vessels. The reduction in blood flow through the liver results in less filtering out of toxic substances in the blood stream and results in an increased risk of hepatic encephalopathy, which develops in 30-50% of the patients, and which further increases with age. As a result, TIPS carries significant risks for patients over 65 years old, which many patients with ascites from NASH are forecast to be.
The only cure for liver disease is a liver transplant. Liver transplants are very limited in availability and result in large healthcare costs. Lifelong use of immunosuppression drugs is required to reduce the risk that the recipient’s body will reject the transplant.
Paracentesis is defined as the removal of fluid from a body cavity via a needle, a trocar, a cannula or other hollow instrument and can be used for either diagnostic or therapeutic purposes.
In the case of ascites, a large-bore needle is inserted into the abdomen and the ascites is drained from the patient’s abdomen over a number of hours. Paracentesis is the most common treatment for refractory ascites worldwide.
However, paracentesis only offers temporary relief from ascites as it needs to be repeated when the ascites re-accumulates, often on a weekly or bi-weekly basis. And in the meantime the patient is left feeling bloated and unwell as the fluid continues to collect.
A TIPS (Transjugular Intrahepatic Portosystemic Shunt) is a shunt to re-route blood flow around the damaged liver into the main blood vessels. The portion of excess blood bypassing the liver, may allow the reduction of portal hypertension and thus, potentially the accumulation of ascites.
Until now, treatment options for refractory ascites have been limited and unsatisfactory for some patients, leaving both patients and doctors in need of a better solution.
