Some medical advances improve the quality of life for patients; some-perhaps fewer-buttress the bottom line for the business of healthcare providers. But as Richard Gemming, vice president of administration at four-hospital Continuum Health Partners in New York notes, "there are very few technologies you can talk about" that accomplish both.
Gemming thinks he has found one such strategy, and it was a relatively simple solution for a problem that affects nearly every patient with end-stage renal disease on dialysis. The solution is being proactive about vascular access, that is, the point where the dialysis machine is hooked up to the patient. Typically, the dialysis machine is connected to a vein that is connected to an artery. The patient's life depends on a functioning, wide-open connection and good blood flow to remove the body's impurities during the dialysis session-"a significant lifeline for them," Gemming says.
"This is the Achilles' heel of the dialysis patient," says Martin Kuhlmann, research laboratory director for the Renal Research Institute, or RRI, a joint venture between dialysis giant Fresenius Medical Care of North America and 992-bed Beth Israel Medical Center in New York, a Continuum hospital. RRI was formed in 1997-Fresenius owns 80% and Beth Israel 20%-to run Beth Israel's three dialysis units and to advance research. That amounts to nearly 600 patients and more than 94,000 dialysis treatments per year, Gemming says.
Fresenius did not purchase Beth Israel's dialysis business outright in part because publicly traded companies cannot own healthcare companies in New York, but it kicked in $15 million for research as part of a 10-year commitment.
Keeping the blood flowing
In terms of patient complications and hospitalizations, vascular access maintenance is arguably the most problematic aspect of dialysis. The average cost for a dialysis patient in 1996 was approximately $62,400 in 1996. About 25% of that amount-$16,000-was spent on vascular access-related matters, according to a 2002 study in Dialysis & Transplantation, a peer-reviewed journal published by Creative Age Publications. A 2001 study in Kidney International, which is produced by Blackwell Publishing on behalf of the International Society of Nephrology, cited a report that stated the average cost of complications caused by vascular access was $7,871 per patient per year. The annual cost to Medicare was 14% to 17% of total spending for dialysis patients, according to the same report.
Gemming notes that it's just part of the normal progression of the disease for grafts to periodically shut down, but when they do, patients can often miss a dialysis session, which can be a life-threatening situation. Dialysis patients typically undergo, on average, 1.5 procedures to manage the access point, or graft, every year as long as they are on dialysis, he says. Nathan Levin, medical and research director at RRI and a professor of clinical medicine at Albert Einstein College of Medicine in New York, says perhaps 20% of all hospital admissions from dialysis units are for vascular access problems, typically from blood clots or infections.
In the not too distant past, maintenance of the graft was reactive. Patients in need of a reopening of the access point were scheduled for an inpatient angioplasty procedure in which a balloon is used to reopen the vessel and then a stent is put in place to keep it propped open just as in coronary angioplasty. Too often though, patients were bumped from the surgery schedule because of the need for more urgent procedures, and a dialysis patient could spend as long as five or six days in the hospital, putting them at risk of infection and of missing a dialysis treatment, Gemming says.
The proactive solution was to build an outpatient vascular access center dedicated to treating dialysis patients. Opened in April 2003, Beth Israel manages the center to avoid self-referral laws that would have restricted RRI's ownership. Beth Israel, which leases the building, operates the site for $800,000 a year. Startup costs were about $350,000, Gemming says. Half of the new suite, which is located across the street from Beth Israel's hospital-sized outpatient services building, is devoted to diagnostic radiology and the other half is what has been christened New York Vascular Access Center. The center has one full-time interventional radiologist, who performs the angioplasties, on staff five days a week. The staff also includes two physician assistants and a medical assistant.
Since its opening, the center has performed 1,000 procedures on dialysis patients-most of them de-clotting procedures and all on an outpatient basis. Gemming says the center would break even with 73 procedures per month but is averaging 120 to 140 procedures per month for the first eight months.
Although there is not yet adequate data to completely assess its cost efficiency, two things are certain: Hospitalizations for dialysis patients have decreased and it has taken a load off Beth Israel's hospital-based radiologists, who now have more time and space for more sophisticated procedures.
"That much we know for sure," Gemming says. Even from an equipment-use standpoint, "This is the most cost-effective way," he adds.
In assessing the effects of a proactive approach on 132 dialysis patients, the study in Kidney International found the aggressive program reduced the number of de-clotting procedures, hospital days and missed dialysis treatments per patient. The total cost of treatment for blood clots was reduced by 49%, even though the proactive strategy resulted in a significant increase in the number of angioplasties performed. That's not hard to understand considering a single vascular access procedure costs $2,326 when performed in an outpatient setting compared with $11,556 in a hospital, according to the Dialysis & Transplantation study.
"We were wasting a lot of money with patients going to the hospital many times because their access became clotted," Levin says. "We're averting failure of the access and treating it so they don't fail completely." And from a business standpoint, "All that work goes to radiologists, which they otherwise wouldn't have," he says. Typically when access shuts down, a surgeon gets the work, either repairing it or creating a new one, Levin says.
As a related matter of policy, RRI is trying to persuade surgeons to create access points using the patient's own veins rather than an artificial graft, or even worse, a tube that goes through a vein near the neck. Patients' own veins work better because the veins can adapt and grow larger, increasing the blood flow. Until recently there wasn't much financial incentive for using the patient's own vein because Medicare paid more for the synthetic piece of plastic, "But I think that is changing," Levin says. Meanwhile, tubular access through the neck, which is prone to infection and offers reduced blood flow, is prevalent in perhaps 25% of all dialysis patients in the U.S.-more than in other developed countries like Germany or Japan, he says.
The vascular access center relies heavily on RRI to identify patients in need of an intervention before a crisis occurs. Patients at the three outpatient dialysis units are constantly watched for changes in their access point in several ways, including studying the data reported by the dialysis machines and through ultrasound. "The essential point to make and where it has value prophylactically is we routinely measure the function of the vascular access in the dialysis units," Levin says. "We make the measure integrated in the dialysis machine."
When things go wrong
Gemming estimates that for every 10 dialysis patients, eight subsequently could be appropriately referred to the vascular access center while two would still require hospitalization.
Unfortunately, Martin Urtiaga, 68, a retired salesman living in Queens, N.Y., fell into the minority of those patients. A diabetic, as are many dialysis patients, Urtiaga was recently undergoing one of his three-times-a-week, four-hour-long dialysis treatments at an RRI center on 96th Street in Manhattan. He was relaxed in the recliner chair, watching the overhead television.
In the three years that Urtiaga has been undergoing dialysis, twice he has required work on his vascular access, which makes use of his own vein, the most recent three months ago, he says. RRI sent him downtown to the vascular access center in Union Square. Though he was told to expect to spend an hour at the center, he says he spent a full day because of complications finding the correct-sized balloon for the angioplasty. He subsequently was admitted to Beth Israel for the procedure and stayed there a few days as he did the other time.
"Lots of things can go wrong," Urtiaga says.
Kidney dialysis is a poor substitute for a real kidney, says Kuhlmann of RRI. A normal kidney cleans 100 cc of blood a minute. Patients usually don't start dialysis until their kidneys are processing less than 10 cc of blood a minute. Once they start dialysis, the best they can hope to process is 20 cc of blood a minute-not even close to a normally functioning kidney, he says.
One research study currently recruiting volunteers at RRI in conjunction with the National Institutes of Health is a trial testing whether patients will do better if they go in for dialysis more frequently than the usual three times per week but for shorter periods of time. Urtiaga, who was asked to volunteer for the study, says that the schedule would not work for him. He already loses a full day each time he makes the lengthy commute by public transportation from Queens for a dialysis treatment, he says.
In total, RRI is involved in 14 research projects, which gives Beth Israel's patients an opportunity to participate in the protocols, Gemming says.
Currently, Beth Israel's vascular access center competes only with a for-profit company in the New York area that does not have the benefit of a backup hospital, Gemming says. Beth Israel is planning to build another center in Brooklyn, which would be close to Continuum's Long Island College Hospital.
Still, when all is said and done, RRI's ultimate goal is to lose its patients, according to Levin. "We try our best to encourage people to have kidney transplants," Levin says. "We do this by supporting the transplant surgeons and we do our best to have patients on the transplant list."