The 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. 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."
Jeffrey Hull, M.D, interventional radiologist of Richmond Vascular Center
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.
Decreasing the number of procedures a patient must undergo to prepare for dialysis, as well as moving fistula creation from hospitals to outpatient settings, is a particular advantage for both patients and healthcare providers as the U.S. deals with COVID-19, according to kidney patient advocate Terry Litchfield.
"The ability to create a fistula with a minimally invasive procedure in an outpatient setting preserves limited hospital resources and lowers the risk of exposure for kidney patients, who already have a higher risk of developing complications with the virus," said Litchfield. "Ellipsys enables physicians to safely create dialysis access, even in the midst of a pandemic, which will make it easier for these vulnerable patients to get the lifesaving dialysis treatments they need."
Recently published long-term data show that 92 percent of Ellipsys fistulas are still functional after two years. The study also found high levels of patient satisfaction with the procedure. Dr. Hull was an author on the 2017 study that demonstrated the safety and efficacy of the Ellipsys system.
Cleared by the FDA in 2018 for patients with end-stage kidney disease, Ellipsys is the first significant innovation in AVF creation in over 50 years.
It transforms a complex surgery into a minimally invasive procedure that can be performed in a hospital outpatient setting, ambulatory surgery center or a physician office. Since 2015, more than 2,000 patients worldwide have had the Ellipsys procedure.
Hull, J., et al. (2020) Maturation for Hemodialysis in the Ellipsys Post-Market Registry. Journal of Vascular and Interventional Radiology. doi.org/10.1016/j.jvir.2020.03.001.