St. David's HealthCare facilities participate in clinical trial to treat chronic kidney disease more safely

Austin, Texas — Several St. David’s HealthCare facilities are participating in a first-ever national clinical trial to evaluate the effectiveness of a new device designed to improve outcomes for arteriovenous fistula creation — a surgically created connection between an artery and a vein, usually in the arm, that makes the vein larger and stronger so it can handle the repeated needles and high blood flow needed for dialysis.

The first implant was performed at St. David’s Medical Center by Ryan Turley, MD, a vascular surgeon who is the principal investigator of the trial at St. David’s HealthCare. Heart Hospital of Austin, St. David’s Round Rock Medical Center and St. David’s South Austin Medical Center are also participating in the trial. No other hospitals in Central Texas are participating.

“For the thousands of Texans with chronic kidney disease — and more than 1 in 7 U.S. adults — a working dialysis access point can help patients begin dialysis sooner and with fewer complications,” Dr. Turley said. “At St. David’s HealthCare, we are proud to participate in this milestone clinical trial that will help set a higher standard for vascular access care.”

Hemodialysis — a life-sustaining procedure that filters waste, toxins, and excess fluid from the blood using a machine when kidneys fail — is the primary mode of survival for patients with failed or failing kidneys. Successful hemodialysis requires a vascular access point where dialysis needles can be inserted for blood to travel in and out of the body. The vascular access site with the best clinical outcomes is the arteriovenous fistula, providing a direct connection of a high flow artery to a lower flow vein. However, these access points do not always work as planned, and some require additional procedures before they can be used.

The novel device is a flexible perivascular wrap designed to improve the usability and durability of arteriovenous access sites. The wrap is bioabsorbable and has a conforming fit for each patient.

Annually, there are more than 200,000 arteriovenous access surgeries done in the U.S., which require some level of intervention to get them working. The novel device is being studied to help veins behave more like arteries and to make the surgery work the first time by preserving high blood flow.

The study will involve approximately 600 patients from up to 30 sites in the country. Patients will be followed for a duration of 36 months.