When Baltimore surgeon Michael P. Lilly prepares a patient for the blood-cleansing process of kidney dialysis, he has several choices. The simplest involves connecting an artery to a vein near the patient's wrist. Once that link, or fistula, is fully established, needles can be inserted into the connection to carry blood to and from the life-saving dialysis machine.
Fistulas have been used since the earliest days of dialysis in the 1960s, but fell out of favor with the introduction of synthetic grafts and catheters a decade later.
Today, fewer than four in 10 dialysis patients nationwide have a fistula, despite overwhelming evidence that they are safer, cheaper and more effective than grafts and catheters. Patients with fistulas are far less likely to develop life-threatening infections, statistics show. Fistulas also last longer and require fewer trips to the hospital for repairs. The cost of caring for a patient with a fistula is thousands of dollars less annually.
Still, fistula rates remain stubbornly low in the United States, and vary dramatically by geography. Dialysis patients in the Pacific Northwest and New England are nearly twice as likely to get one as are patients in the Washington area, which has the lowest fistula rate in the nation.
Even within this region, rates fluctuate sharply. Patients in the District, West Virginia and much of Maryland have just a 1-in-4 chance of getting a fistula, data show. Patients in Northern Virginia: a 1-in-2 chance.
"We're embarrassed being the lowest in the nation," said Nancy Armistead, the head of the Mid-Atlantic Renal Coalition, a federally funded nonprofit working to improve the rate for the 20,000 dialysis patients in the region. "I don't know how else to put it."
As public and private officials struggle to rein in medical costs, the example of the low-tech, inexpensive fistula appears to offer a cautionary tale about the real-world practice of medicine.
Tens of thousands of patients likely to benefit from a fistula don't get one. The reasons are complex and reflect a frustrating collision of social, economic and medical factors, doctors and researchers say.
First, a minority of patients cannot have a fistula because their veins are not strong enough to withstand the procedure, or because of other medical complications.
In some cases, poor patients without insurance aren't seen by kidney specialists. Other times, doctors fail to refer patients in time to get a fistula, which takes several months to mature; instead, the patient gets a catheter or graft. Some surgeons find it easier to retrieve a catheter or graft off the shelf than spend time constructing a fistula. A surprising number of patients prefer catheters, even though statistics show that they are eight times as likely to develop potentially deadly infections.
"Ideally, every patient who can have a fistula should get one," said Lilly, chairman of the department of surgery at Maryland General Hospital in Baltimore. "Unfortunately, it doesn't always work out that way."
Paying a High Price
Medicare, which picks up most of the $15 billion annual tab for dialysis treatment, pays surgeons more for grafts and catheters than fistulas -- in effect, rewarding inferior care. That's because its reimbursement system is based on the time and resources needed to do a procedure, not on the outcome.
"What's missing is the clinical value to the patient," said Robert Zwolak, a vascular surgeon at the Dartmouth-Hitchcock Medical Center in New Hampshire and an expert on the payment rules for dialysis access. "That's not in there."
On average, a surgeon receives $714 for a graft but only $560 for a simple fistula, data show. Catheters and grafts are also prone to clogging, generating more fees for surgeons doing repairs.
"You not only get paid more for the actual procedure, a graft is also a kind of annuity [for surgeons] because you know you have to clean it out regularly," said Brady Augustine, a senior quality adviser at the Centers for Medicare and Medicaid Services (CMS) and a former executive at a for-profit dialysis chain.
According to one estimate, Medicare spends about $1 billion a year for repairs to grafts and catheters. With the number of patients receiving dialysis projected to increase sharply -- from 350,000 today -- because of the surge in diabetes and obesity, that bill is only likely to climb, researchers say.
The impact can be seen in what the government health insurance program pays for patients with the different types of dialysis portals. In 2003, it cost Medicare an average of $52,751 to care for a patient with a fistula, compared with $61,929 for those using a graft and $69,893 for those on a catheter, federal data show.
Patients with grafts and catheters also have a 20 to 70 percent greater chance of dying in the first year of treatment, according to CMS. That's one factor in what the agency says is 5,000 unnecessary deaths each year among dialysis patients suffering chronic kidney disease.
"There is an urgent need for dialysis patients to have safer, higher-quality access with a fistula," said Barry Straube, a CMS physician helping to oversee the quality of care that Medicare patients receive. "Part of that demands that we look at the way we are paying for fistulas."
Medicare officials have begun a campaign to increase fistula use, called Fistula First, with a goal of reaching 66 percent of all dialysis patients by the end of this decade. That would put the United States roughly on par with Europe and Japan.
The campaign calls for widespread educational efforts and could lead to changes in the way the government pays for dialysis care, rewarding specialists and surgeons for raising fistula rates among their patients. At the same time, the effort has a decided "Back to the Future" feel to it, as policymakers and physicians rediscover the value of an older but proven procedure.
A Culture of Grafts
Dialysis developed as a way to rinse toxins from the blood of people with kidney failure. At first, it was largely reserved for a few thousand wealthy patients, according to Lawrence Spergel, a vascular surgeon in San Francisco and a leading advocate for fistulas. "It was a very small number, and they were carefully selected," he said.
That changed in the mid-'70s, when Congress created a separate insurance benefit under Medicare for those with chronic kidney disease. The benefit served as a boon for new treatments, including synthetic grafts and catheters.
Because not all patients are ideal candidates for fistulas, grafts offered another way to connect blood vessels. Needles could then be inserted into the graft, toxins removed and the clean blood recycled back into the patients, who were normally dialyzed three times a week at a hospital or clinic.
While grafts took surgeons slightly longer to implant, patients could start dialysis in about 10 days. By comparison, fistulas take eight to 10 weeks to mature.
"They [grafts] came in different sizes, were flexible and very easy to use," recalled Spergel. "In essence, all you had to do was grab a piece of plastic off the shelf. Our belief was that this was the best thing since apple pie and ice cream."
Grafts surged in popularity, gradually replacing fistulas as the primary means of access for dialysis patients in the United States. "I called it the graft culture. We all relied on the easy way out," said Spergel.
About the same time, doctors realized they could use plastic catheters as an access, inserting the small devices into the jugular vein in the patient's chest and using it as a pump to draw blood out, clean it and recycle it.
The new technologies helped open the dialysis market to thousands of older and sicker patients. Today, about 40 percent of dialysis patients in the United States have a graft, 39 percent have a fistula and the other 21 percent have a catheter.
What surgeons didn't understand at first, Spergel and others said, was that the new technologies were less effective and less safe than fistulas. Grafts and catheters, while easy to use, have a tendency to clot, requiring frequent trips to the hospital for repairs. "It's like a rusty pipe," said Spergel. By comparison, a mature fistula lasts years.
Patients also are prone to infections caused by bacteria that enter the body at the point of a catheter or graft. According to a 2003 estimate for Medicare, a patient with a graft was nearly three times as likely as a fistula patient to develop an infection, and twice as likely to develop other complications.
The problem is even more acute with catheters, data show. Those dialysis patients are eight times as likely to develop an infection and nearly six times as likely to experience other complications.
It is unclear precisely how many dialysis patients die because of these infections. Medicare officials, relying on unadjusted mortality data, put the figure at about 5,000. Many dialysis centers report that infections are the second leading cause of death after heart disease.
In theory, catheters are a bridge for patients who aren't referred in time for a fistula to mature or are in such dire shape that they need to begin dialysis immediately. The idea is that patients will only use them for a few months, while a fistula matures.
But in practice many physicians and patients have grown dependent on catheters because of their ease of use, and are unaware of or willing to overlook the risks.
"When grafts and catheters came out, we weren't aware of the risks," Spergel said. "We only saw the good part. The problem was, it became so easy to use. Patients started to fall through the cracks. Now catheters are being used and abused to the point where the rate has actually increased in recent years."
The chance of getting a fistula varies dramatically from region to region -- and in some cases by Zip code. On average, dialysis patients in the District, Maryland, Virginia and West Virginia have about a 1-in-3 chance of getting a fistula -- the lowest rate in the nation.
Armistead cites a number of factors as contributing to the low rate, including large numbers of uninsured patients. Often, those patients aren't under the care of nephrologists, she said, and aren't referred to surgeons in time for a fistula before starting dialysis.
Another factor may be the medical culture. Surgeons have gotten comfortable using grafts and catheters and don't want to change, she said. Doctors in areas with high fistula rates may be less entrenched in their resistance to using fistulas, Armistead said. In some cases, communications are poor. Armistead cited one area of West Virginia where two medical practices "haven't talked with each other in 10 years," likening it to the Hatfields and McCoys.
Andy Howard, a nephrologist who follows about 250 dialysis patients in Virginia and Maryland, said it's important for specialists to make sure that patients are referred to surgeons well in advance of starting dialysis so they have time to develop a mature fistula. "The timeliness of the referral is critical," he said.
Doctors and researchers in areas with high rates of fistulas cite close working relationships among primary care physicians, nephrologists, surgeons and dialysis centers. In Olympia, Wash., nephrologist Vo Nguyen has become an apostle for fistulas, traveling throughout the area to spread the word.
In 1996, Nguyen said he had an awakening after one of his favorite patients died from an infection caused by her graft. "It was just a shattering experience," he said. "I knew there had to be a better way."
At the time, most surgeons in the area were using grafts. So Nguyen traveled to Europe at his own expense to learn about fistulas. He returned a convert. "Here we have all of these excuses. We say we can't do fistulas because the patients are too obese or too fragile or too poor. It's not true, and we have proven it."
By the year 2000, Nguyen said, nearly all of his approximately 200 patients had been converted to fistulas, including many who had used catheters or grafts for years. "It's so simple. It's common sense," he said. Medicare pays for the conversions.
Armistead said her coalition has tried to reach out but thus far without the same success. "We are working hard to get the word out about fistulas," she said. "We have educational seminars. We take surgeons to dinner. We meet with nephrologists."
The rate in the region is improving. The number of patients with fistulas has climbed by 20 percent since 2003. Still, as of August, the region's rate was just 33.9 percent, compared with nearly 60 percent in the Pacific Northwest.
"It's very frustrating. I can't explain it," said Armistead. "It's not like we're that different than other regions. There's no excuse. We have to do better."