Innovative Access Device Provides Hope for Select Hemodialysis Patients

CLEVELAND, Nov. 4, 2011 /PRNewswire/ -- University Hospitals Case Medical Center physicians are utilizing a novel approach to solve a long standing problem for chronic kidney disease patients on hemodialysis.

In hemodialysis patients, central venous obstructive disease or vein damage severely impacts effective treatments.

UH Case Medical Center's Virginia Wong, MD, who is with the Division of Vascular Surgery, and Assistant Professor of Surgery, Case Western Reserve University School of Medicine, was among the first in the country to surgically implant a HeRO graft device to alleviate the obstruction by gaining access through an arm arteriovenous (AV) fistula or AV graft.

For individuals with this particular problem, conventional hemodialysis access is no longer feasible and options are extremely limited. Fortunately, the novel access method is available for select patients.

"The HeRO graft procedure is a true breakthrough since it bypasses the central venous occlusion, giving these patients an option they didn't have before," says Dr. Wong. "The device is made of a tube and a graft that are implanted under a patient's skin to allow arterial access."

There are three standard options for hemodialysis vascular access today: arteriovenous fistula ("AVF" or "fistula"), arteriovenous graft ("AVG" or "graft") and central venous catheter ("CVC" or "catheter"). An AV fistula is formed by surgically connecting an artery to a vein. This causes more blood to flow into the vein and with time, it grows larger and stronger, facilitating access. The alternative, an AV graft, is a synthetic tube (graft) surgically implanted under the skin that connects an artery to a vein, creating an artificial vein. Risks include bleeding, infection, scarring, and graft or fistula malfunction or failure. Central venous obstruction interferes with or prevents blood return, which can lead to premature access failure or inability to use an arm for future access.

To address this issue, the Hemodialysis Reliable Outflow graft device (HeRO Graft, Hemosphere Inc.) provides long-term AV access for these patients. The polytetrafluoroethylene graft component is sewn to an artery in the arm. The graft is subsequently tunneled under the skin, then connected to a silastic outflow catheter placed transluminally – across and beyond the central venous obstruction – and directed into the right atrium of the heart. Thus, the HeRO graft has an arterial but no venous anastomosis.

"A management strategy was needed for hemodialysis patients with limited upper extremity access options due to scarring from central venous stenosis or occlusion," said Dr. Wong.  "Patients who no longer have an available arm for hemoaccess must have an AV graft placed in their thigh, or else have dialysis through a catheter, which increases the overall risk of infection."

Dr. Wong, a specialist in hemodialysis access, implanted one of the first HeRO devices in a patient from the Cleveland area in 2009. She notes only certain individuals are candidates for the procedure. The HeRO graft is available at medical centers nationally, but it is not presently available at other medical centers in Northeast Ohio.

"The surgeon must be able to assess the anatomic and physiologic characteristics of the patient, be skilled in open and endovascular surgery, and have specific training in placement of the HeRO graft," said Dr. Wong.

SOURCE University Hospitals Case Medical Center