New System Allows Kidney Patients to Begin Dialysis Sooner

A new system namely, the Ellipsys Vascular Access System was found to reduce the time before the kidney failure patients can start lifesaving dialysis treatments, stated a new study led by interventional radiologist Jeffrey Hull, M.D., of Richmond Vascular Center. The findings of the study are published in a recent issue of the Journal of Vascular and Interventional Radiology (JVIR). The new finding was found to have a key impact on the safety of the patient and healthcare costs by decreasing the need for other dialysis procedures that are linked to increased rate of complications.

Arteriovenous fistula (AVF) is the preferred type of vascular access for patients with end-stage renal disease (ESRD) who require hemodialysis. Till now, surgery was the only method to create an AVF, which subjected the patients to longer recovery times and delayed dialysis. The new system Ellipsys System developed by Dr. Hull can be used as a non-surgical alternative to overcome the delayed dialysis issue. The new technology uses a small needle puncture and catheter to create an endovascular AVF (endoAVF).

This is the first U.S.-based study to evaluate the application of the best practices for early maturation. Ellipsys cleared by the FDA in 2018 for patients with end-stage kidney disease is the first innovation in AVF creation in over 50 years.

The best practices include performing balloon angioplasty during the creation of fistula to improve blood flow, complete maturation after just four weeks.

The protocol was also found to lower the number of secondary maturation procedures required to prepare the fistula for dialysis and reduce thrombosis rate. Thrombosis is one of the common complication with fistula creation.

At the Richmond Vascular Center, for 123 patients researchers evaluated patient selection and best practices for preparing ("maturing") Ellipsys fistulas for dialysis.

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The study results revealed that Ellipsys System along with early maturation procedures decreased the average time from fistula creation to dialysis to just 66 days, down from 100 days in the initial U.S. Pivotal Trial. The time to dialysis with surgical fistulas averages 135 days, reported literature.

Study has revealed that 92 percent of Ellipsys fistulas are still functional after two years. Patients were reported high levels of satisfaction with the procedure.

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"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."

"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."

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.

Source-Medindia