Richmond physician Jeffrey Hull and the Ellipsys device (Photo by Jay Paul)
Dialysis is a lifeline to many Americans with kidney failure, one that often entails an operation to prep for the procedure.
Surgery has been required to create a fistula, the joining of an artery and a vein in the arm, to create a place where tubes may be inserted to hook the artery up to a dialysis machine.
That’s been the standard for 50 years, but Jeffrey Hull of Radiology Associates of Richmond has devised a take on the procedure that’s less invasive and creates a more stable connection. Under local anesthesia, a needle is inserted into a vein under the elbow, guided via ultrasound to the site where the fistula will be created, then a catheter creates the connection between the targeted artery and vein.
“We’re using the vein as a tunnel to get under where they make the connection,” Hull says.
It takes about 24 minutes to complete the procedure on average, but it ranges from 10 minutes to 60 minutes, resulting in an immediate and permanent connection that “lasts people forever and is durable,” Hull says. The success rate is about 96%, and there are few complications; possibly some minor bleeding as may occur when blood is drawn, Hull says. It also may reduce the risk of hospitalization for infections, he adds.
The innovation is called the Ellipsys Vascular Access System, and it’s earned a patent and approval from the U.S. Food and Drug Administration. Hull, also director of the Richmond Vascular Center, is a co-founder of Avenu Medical, a California-based medical device company that is manufacturing and marketing the device. The procedure is now being deployed across the country.
There are several advantages.
A fistula can be painful and disfiguring, but this system involves a small cut and requires no sutures. “You go home with a [bandage],” Hull says.
It usually takes several months for a fistula that was created surgically to heal and for the vein to be usable for dialysis, according to the Food and Drug Administration. Also, fistula failure is common in the first year, and raises costs two to three times higher for patients, according to a study in the March 2018 edition of the American Journal of Kidney Diseases.
With Ellipsys, vein mapping is done on the first visit to the doctor’s office, and the Ellipsys system is used on the second, with follow-up visits in the first and fourth weeks following the procedure. At the fourth-week visit, the fistula is prepped for use.
Image courtesy Avenu Medical (Click upper-right corner to expand.)
About Hemodialysis
About 1 in 7 adult Americans have chronic kidney disease, about 37 million overall. It’s estimated that 500,000 people received dialysis in the United States in 2016, the National Kidney Foundation reports. Dialysis is a treatment that cleans the blood, removing wastes and fluids, when your kidneys are failing (10% to 15% of function left, according to the Kidney Foundation). There are two methods, hemodialysis and peritoneal dialysis. About 90% of Americans with kidney failure undergo hemodialysis, according to the Kidney Project at the University of California San Francisco.
A machine filters and cleans your blood in hemodialysis, usually about three times a week for about four hours per session at a dialysis center. A patient is connected to the machine through vascular access to a blood vessel that’s created through a surgical procedure. A fistula is created by directly joining an artery with a vein in the arm, while a graft is formed by using soft tubing to make a similar connection. Another option is called a catheter, in which a tube is placed in a large vein, generally in the neck, according to the Kidney Foundation. Fistulas are physicians’ first choice; they provide the highest blood flow, there is less chance of clotting or infection, and they last longer, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Average life expectancy on dialysis is five to 10 years, according to the Kidney Foundation.
