Patients with chronic and severe abdominal fluid buildup caused by liver cirrhosis have a new treatment option in an alfapump system, available at Dartmouth Hitchcock Medical Center (DHMC).
Sequana Medical’s device is for patients suffering from what is called severe ascites that cannot be successfully addressed with conventional management.
Having tracked trials of the device in Europe, Thomas Burdick, MD, an interventional radiologist, and his colleagues in hepatology, Arifa Toor, MD, and Mary Drinane, MD, have now brought it to DHMC, making it the first non-transplant center in the United States to implant the device.
Who benefits from the device and why
Before finding the device, Burdick often saw patients with end-stage liver disease who required what is called a paracentesis procedure to drain their ascites. He was seeing firsthand how difficult it is for some to manage treating ascites with paracentesis.
Some patients, he says, may only need paracentesis every few months, but because the procedure eases symptoms without addressing the underlying liver damage, many eventually require treatment more frequently.
And while a liver transplant is an option to fix the root cause, a shortage of organs limits access to transplants. But without a transplant, fluid buildup can become so severe that some patients end up coming weekly for paracentesis.
“We have patients who will get five to ten liters of fluid removed every week,” Burdick says. “On the day of their paracentesis, they're very uncomfortable and feel full. Then, they come into the hospital and have an invasive, painful procedure. On that day, with all that fluid shifting, patients usually don't feel very good. Then they go home, and they feel better for a few days. But then, as the fluid starts returning, their symptoms come back.”
With discomfort more than half the week and frequent travel to medical offices, patients can have significant quality-of-life issues, he says.
Burdick wanted to find a better solution.
“It's always been an interest of mine to try and find better ways to treat this challenging patient population,” Burdick says. “Other procedures exist to shunt the fluid into the bloodstream, but the risk of infection can be high.”
How the alfapump works
In late 2024, the alfapump received approval from the Food and Drug Administration (FDA), making it the first U.S.-approved active implantable medical device for the treatment of recurrent or refractory ascites due to liver cirrhosis.
“The alfapump is a mechanical pump about as big as a pacemaker placed inside the abdominal wall,” Burdick explains. “A tube from the pump is inserted into the ascites in the abdomen. A second tube then routes the fluid into the patient's bladder where the ascites is eliminated through urination.”
The pump is recharged through the skin, much like you might charge your phone on a wireless charging puck. It has a programmable run time to avoid interrupting sleep with trips to the bathroom.
How DHMC got the device
When Sequana Medical began rolling out the device, they were concentrating on transplant facilities, where many people awaiting liver transplants receive care. Burdick reached out to the company to encourage them to consider other facilities.
“I talked to them, and I said, ‘There’s a large number of these patients at many smaller facilities. Wouldn't it be great if you could show that it works at non-transplant centers?’ ” Burdick asked.
The company considered it, talked to their Boston representative, and agreed. DHMC also had to determine whether to absorb the financial risk of offering the emerging technology, which costs about $50,000 and is not yet covered by insurance.
Ultimately, DHMC was among the first five U.S. implant sites, helping bring this advanced therapy to patients in northern New England.
What next
The patient who received the first device is doing very well.
“He has been a total success story. He's done fantastically,” Burdick says. “I think it's been a really positive thing for his quality of life. He has not needed another paracentesis since the device was implanted.”
Burdick appreciates the team effort from DHMC’s hepatology division, especially from Toor and Drinane. They are now working to identify more patients who would qualify for this technology. Burdick estimates that about 10 to 12 Dartmouth Health patients could benefit annually at the start, with the program later expanding to a wider population.
“Whenever a new medical procedure comes out, the first patients treated are the sickest of the sick, who don't have any other options,” he says. “As doctors get comfortable with the procedure, the amount of concern that goes into placing these tends to go down. I can see this becoming a much more common procedure that's performed earlier in their disease process or while patients wait for their transplant.”
This article first appeared in the summer issue of Connections Magazine and has been adapted for publication on the Dartmouth Hitchcock Medical Center website.