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What to do with a failing allograft is a challenge that has bedeviled nephrology clinicians for years. The problem affects a small but significant—and growing— number of transplant recipients: In 2002, of more than 100,000 patients who initiated dialysis that year,4%had a failed allograft—nearly double the number of similar patients who started dialysis in 1988. Of patientswho received kidneys in 2006, about 13% had undergone a previous transplant. Many nephrologists caring for these patients have argued in favor of removing the failed organs, saying that these kidneys are associated with inflammation, infection, and perhaps even an increased risk of malignancy, along with an ongoing need for immunosuppression. Others disagree, countering that the allograft may still be producing some urine, and that it is unwise to subject an already fragile patient to yet another major surgery.1, 2 The argument has gone unresolved largely because, until recently, data to support either side have been scarce.

Over the past year, Juan Carlos Ayus, MD, and colleagues with Renal Consultants of Houston, Texas, have presented evidence showing that timely removal of a failed allograft is associated with better patient outcomes than leaving the allograft in place. Using data from the U.S. Renal Data System, they retrospectively reviewed information on nearly 11,000 transplant recipients who returned to long-term dialysis between 1994 and 2004. Of those patients, 31.5% underwent an allograft nephrectomy during the follow-up period. Overall, 34.6% of the study group died, but those who received the nephrectomy had a relative risk of death that was 32% lower than the patients whose allografts remained in place. The authors concluded that receipt of an allograft nephrectomy after returning to long-term dialysis was independently associatedwith improved survival.3

Dr. Ayus believes the failing allograft imposes an additional burden on the patient. “In 2004, we showed that these kidneys cause chronic inflammation. Under the microscope, all of them showed evidence of rejection,” he says. “We established for the first time that the failed kidney allograft is a source of chronic inflammation and should be removed.”3, 4

Compelling Data

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Although the population of patients with failing allografts has been growing in recent years, research on how best to manage these individuals has been slow, due in part to a “lack of communication between transplant surgeons and the nephrologists who see the patients when the failure occurs,” says Dr. Ayus. As a result, patients often return to hemodialysis without a vascular access in place, so they receive an emergency access, which does nothing to improve their chances of a good outcome, he adds.

With solid evidence showing that removing the failed kidney is beneficial, “I thinkwe're going to do better” in terms of managing these patients, he says. “These data are pretty compelling,” says William Bennett, MD, transplant nephrologist at Good Samaritan Hospital in Portland, Oregon. “To show a decrease in the relative risk of death by 32% is pretty compelling evidence that you're doing the patient a favor by taking out their transplant” if it fails, he explains. “I think Dr. Ayus did the renal community a service by pointing this out.”

Dr. Bennett did note that the findings may have been influenced by a selection bias, with the nephrectomy patients being younger or healthier than those who kept their failing allografts, something the authors themselves discussed. Still, he says, “the point is well made that if you leave a transplant in, it's a source of inflammation, which is a risk factor for cardiovascular disease, which is what most people on dialysis die of anyway. Inflammation also makes people less responsive to erythropoietin, so there are a lot of good reasons to remove the transplant, unless it's benefitting the patient in some way.”

Risk Involved

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While, all in all, Dr. Bennett thinks the balance of information now suggests that more of these grafts should probably be removed, not all observers agree. “There are different levels of failed transplants,” says Anthony J. Langone, MD, director of kidney transplantation at the National Veterans Affairs Hospital in Nashville, Tenn. “If you have a patient who has acute rejection, you can't reverse it, and they go into end-stage renal disease, and they're still actively rejecting the kidney, if you were to just take them off immunosuppression and let them be, they're going to have pain, hematuria, and that allograft is going to have to come out emergently. But there are many patients who go many years and don't need a nephrectomy.”

“The bottom line is that no one really knows,” he says. “There is as yet no good, prospective, randomized trial, so no one knows for sure if we should go ahead and do the operation, which is still an operation and carries a risk of a certain mortality, a risk of needing a blood transfusion. And other risks that peoplemention is that when you remove these kidneys, the patients' antibody levels go up. The kidney acted like a sponge, so it took up the antibodies that were directed against it, and when you remove the kidney those antibodies go into the circulation. So the kidney actually helps protect against that.”

“The Ayus paper is interesting, but these large database studies are flawed in many ways,” Dr. Langone tells D&T. “There's a lack of randomization and possible selection bias. So the paper is intriguing, it's thought-provoking, but it's not standard of care to take these kidneys out.”

Bottom Line

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There is still no consensus regarding the optimal management of patients with failed renal allografts. While clinicians should follow these patientsmore closely, better communication is needed between nephrologists and transplant surgeons to help avoid needless morbidity and discomfort in this patient population.

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Access to transplantation among people aged 60 to 75 years doubled from 1995 to 2006.1 All in all, outcomes in this population are good, with a rate of perioperative mortality (death within 30 days of transplantation) of less than 2%.2 Although people aged 65 years or older experience more complications post-transplant than younger patients, most nephrologists agree that, like their younger counterparts, older patients with ESRD do better with a transplant than on dialysis.3 In fact, “If you take away death, elderly people's outcomes, while not equal to those of younger people, are similar, if the patients are carefully selected,” says Gabriel Danovitch, MD, professor of medicine at the DavidGeffen School ofMedicine at the University of California, LosAngeles, and medical director of the school's kidney and pancreas transplant program.

Immune Challenges

Nevertheless, much remains to be learned about the challenges of immunosuppression in the elderly. These patients “typically carry with them multiple comorbidities that are associated with age, such as an increased risk of vascular events, infection, malignancy, and sometimes problems with bladder function. Polypharmacy also is likely to be a problem,” says Dr. Danovitch.

Often, these problems are not accounted for in research. “Many of the databases that show outcomes in the elderly population do not list their comorbidities in enough detail to permit other investigators to draw conclusions about these patients' immune function and other health-related issues,” says Scott Sanoff, MD, assistant professor of medicine in the Division of Nephrology at the University of Virginia School of Medicine in Charlottesville. Like Dr. Danovitch, Dr. Sanoff warns that immunosuppression is particularly tricky in older people due to the comorbidities associated with age, along with a decrease in immune function. “One of the things we get really nervous about in our older population is infection,” which is influenced by immunosuppression as well as age-related immune decline,” he says. “There's also the risk of other morbidities such as peripheral vascular disease, which adds to the infection risk.”

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Since immune function wanes with age, it is not surprising that organ rejection is less of a problem among the elderly than it is in younger patients. However, says Dr. Danovitch, “if older patients do experience rejection, its impact on them is worse because they have a lesser tolerance to the powerful medicines we have to give them.”

Given the paucity of research in this population, Dr. Danovitch believes the best approach is an individualized one, taking into account traditional transplant protocols along with each patient's age, comorbidities, and reaction to the medication.8

Bottom Line

Older people can do very well with a kidney transplant, but they must keep their expectations realistic. “Transplant in a 70- year-old will not make him 40—it will make him 70 with a transplant,” says Dr. Danovitch. Careful patient selection and preparation are the keys to successful outcomes. He advises educating patients about the risks and alternatives, giving them a realistic idea about what can be expected from transplantation, and considering their family support system. “In the end,” he adds, “we have to sitwith our patients and give them our best judgment and educate them.”

BUSINESS

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Fresenius Introduces New Dialysis Machine

Fresenius Medical Care has released the 2008T dialysis system, which combines a hemodialysis delivery system with Fresenius Clinical Data Exchange (CDX) to provide caregivers, for the first time, chair-side access to both dialysis treatment and medical information system (MIS) data to facilitate real-time adjustments to therapy and care plans.

Fresenius introduced the 2008T dialysis system in November at theAmerican Society of Nephrology's 43rd Annual Meeting and Scientific Exposition in Denver, Colo. The machine offers the Fresenius Clinical Data Exchange (CDX), offering a fully integrated dialysis therapy and management information system. It was developed to help physicians and clinic operators adjust to the new bundled payment environment due to take effect in theU.S. this month.

The platform accommodates MIS software from third-party vendors aswell as the company's proprietary systems, providing immediate access to all dialysis treatment and clinical trending data. This integrated approach streamlines workflow and maximizes data collection for comprehensive billing.

Available immediately, the 2008T currently is scheduled to be marketed in North America and is cleared for use in the U.S. and Canada by the FDA and Health Canada. The 2008T was developed in close association with the Renal Research Institute.

FDA Approves IDE for Baxter/DEKA Home HD System

The U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application for a home hemodialysis system in development through a collaboration between Baxter International and DEKA Research and Development. The IDE approval allows the companies to initiate a clinical study in patients undergoing hemodialysis treatment.

DEKA and Baxter expect to begin a clinical study in mid-2011 in the U.S. to assess device performance and safety in patients undergoing hemodialysis. An additional study, scheduled to begin in 2011 in Canada, will focus on device performance and safety in a nocturnal setting. Successful completion of this study will support regulatory approval in Europe, which is expected in 2012. The companies expect to seek regulatory approval of the system in the U.S. in 2013.

PATIENTS

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New Exercise Guidelines for Patients with Type 2 Diabetes

The American Diabetes Association and theAmerican College of Sports Medicine has issued a joint statement outlining new guidelines on exercise for people with type 2 diabetes mellitus (T2DM).Apanel of nine experts developed the recommendations, published last month in the journal Medicine & Science in Sports & Exercise.

The new guidelines provide specific advice for those whose diabetesmay limit vigorous exercise and call for at least 150 minutes a week of moderate-to-vigorous aerobic exercise spread out at least three days during the week, with no more than two consecutive days between bouts of aerobic activity. Additionally, aerobic activity alone cannot give full benefit of exercise to diabetic individuals, says the statement. Recent research has shown that resistance exercise is as important in diabetesmanagement.

While many physicians are cautious about prescribing exercise to individuals with type 2 diabetes, the guidelines stress that the majority of people with T2DM can exercise safely, as long as they take certain precautions.

For more information on the guidelines, visitwww.diabetes.org.

ASSOCIATIONS

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Kidney School Wins Health Communication Award for Excellence

Kidney School, run by the Medical Education Institute in Madison, Wis., has been awarded the 2010 Aesculapius Award of Excellence from the non-profit Health Improvement Institute in Bethesda, Md. The award recognizes excellence in communicating health information online. Kidney School is a free online education program for people with chronic kidney disease (CKD) stages 3–5. Since its launch in 2002,

Kidney School has become the largest CKD education program in the world, reaching nearly 400,000 visitors each year. The site features 16 interactive modules to allow patients and family members to learn about kidney disease, treatment options, coping skills, lab test, diet and nutrition, and more. Dialysis educators can also use the website to help meet patient education requirements established by CMS.

Visit Kidney School atwww.kidneyschool.org.

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References

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