OU Tulsa Vascular Surgeons Pioneer New Procedure for Kidney Dialysis Patients

For the first time in many years, a major technological advance is changing treatment for patients requiring dialysis for kidney failure.

OU Medicine vascular surgeons in Tulsa were the first surgical team in the United States to perform the new procedure using a device called the Ellipsys Vascular Access System. Traditionally, patients with kidney failure would first undergo a surgery in which an artery and a vein in their arm were sewn together to accommodate the increased blood flow required for dialysis. The new approach uses a catheter-based system guided by ultrasound to create the same outcome in a quicker, less invasive procedure.

“We’re seeing a lot of enthusiasm from patients about this new procedure,” said Peter R. Nelson, M.D., chief of the Section of Vascular Surgery, OU Physicians Tulsa. “It requires minimal anesthesia, no incision and is performed entirely with ultrasound guidance, which carries no risk to the patient.”

The fusing of a vein and artery in preparation for dialysis is called an arteriovenous fistula. Without it, a person’s veins alone would not be sturdy enough to handle the needles and increased flow as a dialysis machine removes waste products from the blood. The traditional, surgical procedure, while effective, took longer to perform and the patient had to wait about three months for the vein to thicken in preparation for increased pressure.

The new procedure creates a percutaneous, or incision-less, arteriovenous fistula, and the patient requires only local anesthesia or a nerve block. Using ultrasound, the surgeon locates a spot just below the elbow where a vein runs next to the radial artery. A catheter-based device is inserted into the vein and guided to the point where it is adjacent to the artery. The surgeon punctures through the walls of both the vein and artery, and the device clamps them together, emitting low heat to fuse them and create the connection. The fistula can be seen immediately with ultrasound.

Not only is the new procedure completed much faster – about 30 minutes vs. two hours for the surgical approach – but the patient’s veins are potentially ready to undergo dialysis much more quickly, Nelson said. Experience with the new procedure to date suggests dialysis can begin in as little as two weeks, compared to about three months with the surgical procedure. In addition, data from the clinical trial that led to approval of the Ellipsys device showed that these fistulas required fewer repair procedures over time than the surgically created fistulas.

“Our patients have been very satisfied with the new procedure,” Nelson said. “They don’t have any pain or discomfort, and it doesn’t require radiation, as many other procedures do. We do these procedures in our outpatient clinic, and patients can go home in about 30 minutes.”

As the Tulsa surgeons prepared to do their first case, they reunited with a physician they previously trained in the OU Tulsa vascular surgery fellowship, Alexandros Mallios, M.D. After finishing the program, Mallios returned to his home of Paris, France, where he helped to develop Ellipsys in Europe. He became an international leader in performing the procedure and relayed his experience first-hand when he returned to Oklahoma for the launch of the device.

The vascular surgery team also took part in another milestone when they performed the procedure for the first time at a VA facility, the Jack C. Montgomery VA Medical Center in Muskogee.
As part of an academic medical system, the OU Medicine vascular surgeons will train their residents and fellows to perform the new procedure, ensuring they have the most up-to-date skills when they are ready to practice surgery on their own.

In addition, OU’s vascular surgery group will serve as the lead site for the post-market clinical trial required by the FDA to ensure that patients continue to receive good results as use of the procedure expands.

“The fact that there haven’t been technical advances in this area for a long time makes this particularly exciting,” Nelson said. “People are seeing that we’re doing something new and innovative. There are many patients yet to come who will benefit from this technology.”