September 3, 2020
Ellipsys Vascular Access System Study
Ellipsys Vascular Access System reduces the time before patients with kidney failure can start lifesaving dialysis treatments, while requiring fewer secondary procedures, according to a new study led by interventional radiologist Jeffrey Hull, M.D., of Richmond Vascular Center. This could have a significant impact on patient safety and healthcare costs by reducing the need for other forms of dialysis access that are associated with higher rates of complications.
For patients with end-stage renal disease (ESRD) who require hemodialysis, the preferred type of vascular access is an arteriovenous fistula (AVF), a permanent connection between a vein and artery in the arm. Until recently, surgery was the only way to create an AVF, but that subjects patients to longer recovery times and, as a result, delayed dialysis. Dr. Hull helped develop the Ellipsys System as a non-surgical alternative; the technology uses just a small needle puncture and catheter to create an endovascular AVF (endoAVF).
The prospective study, involving 123 patients at Richmond Vascular Center, evaluated patient selection and best practices for preparing (“maturing”) Ellipsys fistulas for dialysis. The results show that use of the Ellipsys System along with early maturation procedures reduced the average time from fistula creation to dialysis to just 66 days, down from 100 days in the initial U.S. Pivotal Trial. In the U.S., literature reports the time to dialysis with surgical fistulas averages 135 days.
This “rapid maturation” is important because it can potentially reduce or even eliminate the length of time patients require a central venous catheter (CVC) for dialysis. Compared to fistulas, CVCs are associated with significantly higher rates of complications, like infection and even death. Despite these risks, 80 percent of patients in the U.S. still start their dialysis with a catheter.
“Catheters are a less than optimal choice for dialysis access and the goal is to always get them out as soon as possible to avoid serious complications,” said Dr. Hull. “With Ellipsys, we have the unique ability to create fistulas in the office during the patient’s initial visit, thus avoiding surgery at the hospital and reducing physician visits. This enables us to streamline the dialysis timeline and reduce patients’ total catheter contact by a significant amount—sometimes by as much as four months. This will have a tremendous impact on quality of life for patients.”
Published in a recent issue of the Journal of Vascular and Interventional Radiology (JVIR), Dr. Hull’s study demonstrates real-world outpatient use of the Ellipsys endoAVF System. It is also the first U.S.-based study to evaluate the application of best practices for early maturation. These best practices include performing balloon angioplasty during fistula creation to improve blood flow, as well as completing maturation after just four weeks. In addition to shortening the dialysis timeline, this protocol decreased the overall number of secondary maturation procedures required to prepare the fistula for dialysis and reduced the rate of thrombosis, a common complication with fistula creation.