Leap Forward for Kidney Dialysis
Breakthrough technology reduces complications, costs and bleeding time for hemodialysis patients.
Shirley's story
Shirley Musgrave is a fighter. The 66-year-old Tucson, Arizona resident has battled three major diseases- Parkinson's, diabetes and high blood pressure-for years. A year and a half ago, she added a fourth ailment, kidney disease, to that list. Despite all she had endured over the years, Musgrave's initial experience with hemodialysis-a lifesaving process that cleans the blood in people with kidney disease-nearly broke her fighting spirit.
Hemodialysis itself was not painful or difficult for Musgrave. But finding the right method to access her veins to allow blood to exit and enter her body for cleaning through a dialysis machine became a grueling ordeal.
Musgrave's experience is not unique. Many patients like her with kidney disease begin dialysis under emergency conditions. In fact, they make up the largest growing group of patients undergoing dialysis.1 That typically means they need to have a tubing system called a central venous catheter (CVC) placed in their neck region to connect the dialysis machine to one of their main blood vessels.
While physicians prefer to avoid CVCs because they are costly, can lead to infection, and often damage the patient's central veins to the point that they become useless for dialysis, there was no alternative until recently. Unless a patient could wait three to six weeks to begin dialysis, a CVC was the only way to access the blood vessels.
That's how Musgrave's dialysis began-with the placement of a CVC. An artificial graft -a tube-was then placed just below the skin in her forearm to use in a few weeks to route blood to and from the dialysis machine.
But because Musgrave's graft had complications, the surgeon suggested a breakthrough technology, a vascular access graft made of revolutionary self-sealing polyurethane. This new graft can be used for dialysis within 24 hours of implantation, and the advanced material helps patients stop bleeding much faster after their hemodialysis needles are removed.
Musgrave is thrilled with the new technology. Her new graft has allowed blood to flow smoothly to and from the dialysis machine for more than 18 months.
Replacing kidney function
In healthy patients, kidneys act as filters, cleaning the blood and removing extra fluid in the form of urine. Kidneys also produce substances that keep the body functioning properly.
In patients with very limited kidney function, dialysis in necessary. Specifically, dialysis removes waste, salt and excess water to prevent them from building up in the blood. It also keeps a safe level of certain chemicals in a patient's blood, and helps control blood pressure.2 A dialysis machine and a filter called a dialyser are used to accomplish these functions.
Before dialysis can begin though, a vascular surgeon needs to create an access point to allow blood to enter and exit the body for cleaning. Physicians prefer to create a natural access, called a fistula, by joining an artery to a vein. This creates a larger blood vessel, which is necessary since the needles used to deliver blood to and from the dialysis machine are about the diameter of a pencil.
For many patients, including Musgrave, a fistula is not possible because of the poor quality of their blood vessels. Physicians then used a traditional graft for such patients. But both fistulas and traditional grafts must mature for two to six weeks after they have been created or implanted before they can be used for dialysis. That is why CVC use is so common.
Musgrave's first few dialysis treatments were done with the CVC; when her graft matured, it was used. "It worked for about three weeks, then it plugged up," she says.
By then Musgrave's CVC had been removed because the external tubes made her susceptible to infection. "So they sent me to the hospital for declotting. They had to do the same procedure in another week or two and then it would clog up again," she explains. "I had 8 surgeries in two months time. It got so bad they had to put another CVC in," she says.
That's when her surgeon suggested the polyurethane graft. That was March 2002; she is still using the same graft today without any complications.
The new polyurethane graft
Musgrave's new graft is a white tube, about 12 inches long and about 6 mm in diameter-slightly larger than the diameter of a ball point pen. It has a sponge-like feel to it, and it is implanted in Musgrave's arm.
The graft is visible under the skin-so dialysis staff can see where to insert the two dialysis needles. One needle draws blood out of the system to be sent to the dialyser, the other returns clean blood to her body. When the needles are removed after dialysis, the graft's polyurethane material seals itself, quickly stopping Musgrave's bleeding.
Because of the size of dialysis needles, prolonged bleeding can be a problem. One study shows that with the new polyurethane graft, more than 80 percent of patients stopped bleeding in five minutes or less. The same study showed that less than a third of the patients with grafts made of another material, ePTFE, stopped bleeding in five minutes or less.
Musgrave says that after dialysis with the old graft, her daughter or husband had to press for 10 to 15 minutes where the needles had been removed to stop the bleeding. "Because I have Parkinson's I don't have the hand strength to put pressure on it myself," she explains. She cannot use a clamp with the new graft because it could damage the special material in the graft, but with the new graft the bleeding stops in two minutes, she says.
The next best thing to natural tissue
If the new graft had been available to her at the beginning of her dialysis treatments, Musgrave may have avoided the placement of CVCs, which, clinicians say, is a huge benefit.
Dr. William Fiore, Chief of Vascular Surgery at Viahealth in Rochester, New York says he prefers to use a patient's own tissues to create a fistula for dialysis, but when that is not an option, the polyurethane graft like Musgrave has is the next best thing. He is especially encouraged because early use of the new graft for dialysis means so many patients can bypass a CVC.
"I can't emphasize enough why it is good to avoid a central catheter," Fiore says. "People who have had too many of them can have their central veins collapse, and then the only other access you have is the groin area."
Health Care Savings
Like so many advances in medical technology, this breakthrough means benefits for health care providers and payers as well as patients. Complications like Musgrave experienced with previous methods of access are costly and time-consuming to treat. Avoiding them allows clinicians to use their time more productively. Reducing bleeding time also reduces staffing costs.
But perhaps most critical, because dialysis can begin almost immediately after placement of the graft, patients and health care providers may be able to avoid the high costs and potential risks of having a CVC implanted to create emergency access for dialysis. Approximately 250,000 temporary or long-term hemodialysis catheters are inserted annually in the United States.3
One study has demonstrated that 2.3 hemodialysis catheters per patient per year are needed for the average patient undergoing dialysis.4 Another report shows that the use of catheters for dialysis remains high and that this is the most costly group of patients according to the Medicare database.5 The cost of implanting a CVC, combined with the cost of treating CVC-related complications like infection, is estimated at $2,500. 6
The new polyurethane graft, which costs about $1,000, can be used for dialysis so much earlier it could dramatically reduce the need for CVCs. Physicians like Dr. Fiore hope most CVCs-and their costs and complications-can be avoided by using the innovative graft instead.
Reducing post-dialysis bleeding time also produces cost savings. Assuming a 15 minute reduction in bleeding time per dialysis session, $1170 in nursing time could be saved annually, based on 156 dialysis sessions per year and $30 per hour for the cost of nursing time. 7
The potential for cost savings with the new technology is significant. There are around 250,000 hemodialysis patients in the United States, growing at a rate of six percent per year. Medicare spending on hemodialysis for patients with end stage renal disease, or kidney failure, reached $12.7 billion in 1999. Today, it is estimated that 10 percent of Medicare's budget is spent on dialysis to treat kidney failure. 8
Musgrave can't assign a dollar amount to the value of her new graft. Few complications, avoidance of another CVC, and the hours saved because of reduced bleeding time, are benefits she finds immeasurable.
1 Glickman, et al, Multicenter evaluation of a polyurethaneurea vascular access graft as compared with the expanded polytetrafluoroethylene vascular access graft in hemodialysis applications. Journal of Vascular Surgery, Volume 34, number 3, September 2001, p. 465.
2 National Kidney Foundation website, URL: http://www.kidney.org/general/aboutdisease/hemodialysis.pdf
3 Trerotola SO Hemodialysis catheter placement and management. Radiology 2000; 215:651-8
4 Rocco MV, Bleyer AJ, Burkhart JM. Utilization of inpatient and outpatient resources for the management of hemodialysis access complications. American Journal of Kidney Disease, 1996; 28:250-6
5 Egger P. Medicare expenditures for fisutal, graft and catheter-access procedures. Presented at the Vascular Access for Hemodialysis VII. 2000 May; San Antonio, TX.
6 AdvaMed template Bard completed.
7 AdvaMed template Bard completed.
8 Template Bard completed for AdvaMed
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