New Stent Improves Ability to Keep Vessels Open for Dialysis Patients

ScienceDaily (Feb. 10, 2010) Kidney dialysis patients often need repeated procedures, such as balloon angioplasty, to open blood vessels that become blocked or narrowed at the point where dialysis machines connect to the body. These blockages can impact the effectiveness of hemodialysis, a life-saving treatment to remove toxins from the blood when the kidneys are unable to do so. But a new FDA-approved stent graft can keep these access points open longer, reducing the number of procedures these patients may need, according to research from the University of Maryland published in the February 11, 2010, edition of the New England Journal of Medicine. "This is the first large-scale randomized study to find a therapy to be superior to the gold standard of balloon angioplasty. We found that using this new stent for dialysis patients whose access grafts have become narrowed improves graft function. It also clearly reduces the need for repeated invasive procedures and interruption of dialysis," explains lead author Ziv Haskal, M.D., chief of vascular and interventional radiology at the University of Maryland Medical Center. Dr. Haskal is also professor of diagnostic radiology and nuclear medicine, and surgery at the University of Maryland School of Medicine. The prospective multi-center study took place at 13 sites across the country and enrolled nearly 200 patients. Ninety-seven patients received angioplasty with the new stent, which is a small metal scaffold inserted in the patient's arm, compared to 93 who received angioplasty alone. In the study, patients with the stent graft were more than twice as likely to have open vessels compared to the angioplasty only group after six months. The recurrence of vessel narrowing, restenosis, was nearly three times lower with the stent group, (27.6 percent vs. 77.6 percent). In later follow-up, some patients still had functioning grafts two years after the stent graft was first implanted. "Results of this research should change the way we treat hemodialysis patients. In this study, patients who received angioplasty alone were twice as likely to need additional procedures compared to those who had the stent in addition to angioplasty," adds Dr. Haskal. "That can translate into cost savings and improved quality of life for these patients, who already spend about nine to 12 hours a week in dialysis. We can now start considering grafts as something that may last for years in dialysis patients, instead of months." According to the researchers, the cost to treat dialysis access failure amounts to about $1 billion per year, and the number of patients needing hemodialysis is expected to continue to grow substantially over the next decade.

Kidney failure patients often have a synthetic portal, known as an access graft, embedded into their arm before they begin hemodialysis. The access graft works like an artificial blood vessel, allowing needles to be inserted repeatedly, so the blood can be circulated out of the body, filtered in a machine and then returned to the patient's circulatory system. Patients must undergo dialysis several times a week. (Another less commonly used form of dialysis, peritoneal dialysis, filters waste by using the peritoneal membrane inside the abdomen. Patients inject a special solution into the body, which is later drained from the abdomen after the toxins are filtered. Peritoneal dialysis can be done at home, but must be done every day.) For hemodialysis, scar tissue naturally forms at the edges of the access grafts. That scarring can impede blood flow, requiring doctors to perform angioplasty to open the vessels. In that outpatient procedure, doctors insert a balloon into the blood vessel and inflate the balloon to open the narrowed artery or vein. Following angioplasty, vessel narrowing frequently recurs, requiring repeated procedures, up to several times a year. If scarring becomes too severe and repeated angioplasties do not work, the patient may need another procedure put in an access graft at a different site on the arm. Other therapies have been compared to balloon angioplasty, but, until now, none has shown benefit in a prospective randomized study. "More than 350,000 Americans are currently receiving dialysis. These patients need those access grafts to be as durable as possible because they only have so much space on their arms for the surgical creation of new access grafts. Our research has shown that using this stent graft to treat failing accesses keeps them open longer that the existing gold standard; it offers a real, longer-term solution for patients, reducing the need for repeated surgeries. This research suggests that physicians may need to make a fundamental change in their approach to treating hemodialysis patients," says Dr. Haskal. This self-expanding metal stent graft creates a scaffold to keep the blood vessel open. It is encapsulated by polytetrafluoroethylene, the same material from which most dialysis grafts are made. The device allows the physician to mimic the effect of surgery at the scarred area without actually performing surgery. "This study offers strong evidence of the benefit of using this new stent therapy for hemodialysis patients. It represents the type of important clinical research with direct patient benefit undertaken by physicians at the University of Maryland School of Medicine," says E. Albert Reece, M.D., Ph.D., M.B.A, vice president for medical affairs, University of Maryland, and dean, University of Maryland School of Medicine. Dr. Haskal is leading another large study that is currently enrolling patients to assess the benefits of the device over a longer period of time. The other sites participating in this study were the Hospital of the University of Pennsylvania; University of Texas, Southwestern Medical Center; Oregon Surgical Consultants, Portland, OR; Open Access Vascular Access Center, Miami, FL; Vascular Access Center, Augusta, GA; Tucson Vascular Surgery; Indiana University School of Medicine; Bamberg County Hospital and Nursing Center, Bamberg, SC; and Vascular Access Center of Frontenac Grove,

Frontenac, MO. This study was funded by Bard Peripheral Vascular, Inc., manufacturer of the Flair Endovascular stent graft. Journal Reference: Haskal et al. Stent Graft versus Balloon Angioplasty for Failing Dialysis-Access Grafts. New England Journal of Medicine, 2010; 362 (6): 494 DOI: 10.1056/NEJMoa0902045 University of Maryland Medical Center (2010, February 10). New stent improves ability to keep vessels open for dialysis patients. ScienceDaily. Retrieved December 4, 2012, from http://www.sciencedaily.com /releases/2010/02/100210172218.htm

Dialysis at Home Is Just as Effective as in the Clinic, Study Suggests

ScienceDaily (Jan. 13, 2011) Patients returning to dialysis after kidney transplant failure present unique challenges compared with other dialysis patients: they have been exposed to very powerful immunosuppressive medications and have been on dialysis for a longer period of time than other dialysis patients. This puts them at particularly high risk for various complications and death. According to a study appearing in an upcoming issue of the Clinical Journal of the American Society Nephrology (CJASN), despite complications, these patients can choose to undergo dialysis in the comfort of their own homes. Patients who have had a kidney transplant are used to managing their own therapy, enjoying the ability to travel, and living a relatively flexible lifestyle and may therefore be well-suited to peritoneal dialysis (home-based) rather than hemodialysis (clinicbased), when they return to dialysis after transplant failure. Despite the many potential benefits of peritoneal dialysis over hemodialysis -- including ease of performing the therapy at home, avoidance of hospital visits several times a week, and more flexibility to travel -- only a very small proportion of patients returning to dialysis after transplant failure end up choosing to undergo peritoneal dialysis in both Canada and the United States. Jeffrey Perl, MD (St. Michael's Hospital, University of Toronto, Canada) and his colleagues evaluated the impact that dialysis type (peritoneal vs. hemodialysis) has on the survival of patients returning to dialysis after transplant failure. The investigators studied 2,110 adult Canadian patients who initiated dialysis after their kidney transplant failed between January 1991 and December 2005. The researchers evaluated the impact of initial dialysis type on early (2-year), late (after 2 years), and overall deaths.

Hemodialysis and peritoneal dialysis patients died at similar rates in all analyses (early, late, and overall). "It is important to empower patients who have kidney transplant failure to realize that despite the severe disappointment of returning to dialysis, they still have many options for dialysis therapy, which include opportunities for home-based therapies," said Dr. Perl. "I hope this research helps guide patients and the health care professionals treating them to make informed decisions regarding dialysis modality decisions, namely that peritoneal dialysis is as effective a therapy as hemodialysis in patients returning to dialysis after kidney transplant failure." Study co-authors include Omar Hasan, MBBS (Brigham and Women's Hospital); Joanne Bargman, MD, S. Vanita Jassal, MD (University of Toronto, Canada); Depeng Jiang, PhD (Li Ka Shing Knowledge Institute and St. Michael's Hospital, University of Toronto, Canada); Yingbo Na (Canadian Institute of Health Information and Canadian Organ Replacement Register, in Toronto, Canada); and John Gill, MD (St. Paul's Hospital, University of British Columbia, in Vancouver, Canada). Journal Reference: Jeffrey Perl et al. Impact of Dialysis Modality on Survival after Kidney Transplant Failure. Clinical Journal of the American Society Nephrology, January 13, 2011 DOI: 10.2215/CJN.06640810 American Society of Nephrology (2011, January 13). Dialysis at home is just as effective as in the clinic, study suggests. ScienceDaily. Retrieved December 4, 2012, from http://www.sciencedaily.com /releases/2011/01/110113213045.htm

There's No Place Like Home -- For Dialysis

ScienceDaily (Oct. 4, 2012) Most patients with chronic kidney disease who undergo hemodialysis put up with a grueling treatment regimen that involves going into a clinic several days a week and sitting through a three-to-four hour dialysis session at each visit. Home hemodialysis is more accessible than ever, though, with the advent of newer systems that are easier for patients to learn, use, and maintain, according to a review appearing in an upcoming issue of the Clinical Journal of the American Society of Nephrology (CJASN). The authors offer suggestions for how to overcome barriers and establish a successful home hemodialysis program. "There is virtually no other disease that requires patients to make such considerable changes in their lifestyle as a diagnosis of end-stage renal disease and the need for

dialysis therapy does," said Rajnish Mehrotra, MD (University of Washington, Seattle). "To ease the challenge associated with such a diagnosis, offering patients choice allows them to select a dialysis therapy that best fits into their lifestyle and their expectations." Home hemodialysis is one type of dialysis therapy, but it is available to less than 2% of dialysis patients in the country. Home hemodialysis requires extensive patient training, nursing education, and infrastructure support to maintain a successful program. Also, reluctance to start such programs is widespread because many physicians do not have experience with home hemodialysis. Bessie Young, MD (University of Washington, Seattle) worked with Dr. Mehrotra and others to provide an in-depth review to describe the benefits and barriers to home hemodialysis, focusing on patients, physicians, practices, and dialysis facilities. Benefits of home hemodialysis include: Potential for greater dialysis delivery (more frequent or overnight treatments) Improved quality of life Patient independence and employment potential Greater ability to travel 20%-50% less costly than in-center hemodialysis depending on the machine. Barriers to home hemodialysis include: Lack of patient awareness and education about home hemodialysis Patients' perceptions, including fear of change and lack of self-confidence Physicians' education about home hemodialysis Machine complexity, which is now minimal with newer, easier-to-use systems Inadequate payment to providers for home hemodialysis training. "Home hemodialysis has been successfully used by thousands of patients and should be available to everyone on or initiating dialysis. It is a safe, efficient modality that allows patients the ability to increase their frequency of dialysis, which may provide a potential survival benefit," said Dr. Young. Study co-authors include Christopher Chan, MD, Christopher Blagg, MD, Robert Lockridge, MD, Thomas Golper, MD, Fred Finkelstein, MD, Rachel Shaffer, and Rajnish Mehrotra on behalf of the ASN Dialysis Advisory Group (DAG).

Journal Reference: 1. B. A. Young, C. Chan, C. Blagg, R. Lockridge, T. Golper, F. Finkelstein, R. Shaffer, R. Mehrotra. How to Overcome Barriers and Establish a Successful Home HD Program. Clinical Journal of the American Society of Nephrology, 2012; DOI: 10.2215/CJN.07080712 American Society of Nephrology (2012, October 4). There's no place like home -- For dialysis. ScienceDaily. Retrieved December 4, 2012, from http://www.sciencedaily.com /releases/2012/10/121004201044.htm

New Evidence of the Benefits of Home Dialysis for Kidney Patients

ScienceDaily (June 21, 2011) Researchers at St. Michael's Hospital have found more evidence of the benefits of home dialysis for patients with kidney failure. Cells that help protect blood vessels work better in patients who undergo dialysis at home during the night than those who undergo standard daytime dialysis in a hospital, according to Dr. Darren Yuen, a nephrologist. This is important for patients with kidney failure, which causes damage to the endothelial cells that line blood vessels and help control the flow of blood. While standard dialysis in hospital is helpful for treating kidney failure, many patients still develop blood vessel damage that can lead to problems with walking or even amputation. Dr. Yuen studied the function of cells called early-outgrowth endothelial progenitor-like cells (EPLCs). These cells, found in bone marrow and in the blood, can protect damaged endothelial cells and promote the growth of new ones, leading to healthier blood vessels. Dr. Yuen compared patients who receive home dialysis at night with patients receiving standard dialysis three times a week in hospital. He found that EPLCs from patients receiving home dialysis promoted new blood vessel growth better than EPLCs from patients on standard hospital dialysis. The results of his research appear in the June issue of the Clinical Journal of the American Society of Nephrology. In his study, done in collaboration with the University Health Network, Dr. Yuen injected EPLCs from people receiving hospital dialysis into rats with blood vessel damage. He found no added improvements in blood vessel growth or blood circulation.

But when he injected EPLCs from patients undergoing nighttime dialysis at home, the results were almost as good as if the cells had come from healthy people. Since home dialysis lasts for six to eight hours a night, five to six times a week, the toxins and other waste products that build up in kidney failure are more effectively removed, he said. The greater removal of these toxins may be responsible for the better function of EPLCs from patients on home dialysis, he said. Dr. Yuen said his study suggests that frequent nighttime dialysis might be better for some patients with blood vessel damage. Nocturnal home hemodialysis originated in Toronto in 1994 at the Wellesley Hospital, which later merged with St. Michael's. St. Michael's also offers conventional hospital dialysis as well as another form of home dialysis known as peritoneal dialysis, in which cleansing fluids are pumped into a patient's abdomen through a catheter tube and waste products are drained several times a day. Previous research has found that in addition to the convenience, patients on nighttime home dialysis feel better and have more energy when compared with patients who undergo conventional hospital dialysis. Journal Reference: 1. D. A. Yuen, M. A. Kuliszewski, C. Liao, D. Rudenko, H. Leong-Poi, C. T. Chan. Nocturnal Hemodialysis Is Associated with Restoration of Early-Outgrowth Endothelial Progenitor-Like Cell Function. Clinical Journal of the American Society of Nephrology, 2011; DOI: 10.2215/CJN.10911210 St. Michael's Hospital (2011, June 21). New evidence of the benefits of home dialysis for kidney patients. ScienceDaily. Retrieved December 4, 2012, from http://www.sciencedaily.com /releases/2011/06/110621093311.htm

Dialysis at Home Is Just as Effective as in the Clinic, Study Suggests

ScienceDaily (Jan. 13, 2011) Patients returning to dialysis after kidney transplant failure present unique challenges compared with other dialysis patients: they have been exposed to very powerful immunosuppressive medications and have been on dialysis for a longer period of time than other dialysis patients. This puts them at particularly high risk for various complications and death. According to a study appearing in an upcoming issue of the Clinical Journal of the American Society Nephrology (CJASN), despite complications, these patients can choose to undergo dialysis in the comfort of their own homes.

Patients who have had a kidney transplant are used to managing their own therapy, enjoying the ability to travel, and living a relatively flexible lifestyle and may therefore be well-suited to peritoneal dialysis (home-based) rather than hemodialysis (clinicbased), when they return to dialysis after transplant failure. Despite the many potential benefits of peritoneal dialysis over hemodialysis -- including ease of performing the therapy at home, avoidance of hospital visits several times a week, and more flexibility to travel -- only a very small proportion of patients returning to dialysis after transplant failure end up choosing to undergo peritoneal dialysis in both Canada and the United States. Jeffrey Perl, MD (St. Michael's Hospital, University of Toronto, Canada) and his colleagues evaluated the impact that dialysis type (peritoneal vs. hemodialysis) has on the survival of patients returning to dialysis after transplant failure. The investigators studied 2,110 adult Canadian patients who initiated dialysis after their kidney transplant failed between January 1991 and December 2005. The researchers evaluated the impact of initial dialysis type on early (2-year), late (after 2 years), and overall deaths. Hemodialysis and peritoneal dialysis patients died at similar rates in all analyses (early, late, and overall). "It is important to empower patients who have kidney transplant failure to realize that despite the severe disappointment of returning to dialysis, they still have many options for dialysis therapy, which include opportunities for home-based therapies," said Dr. Perl. "I hope this research helps guide patients and the health care professionals treating them to make informed decisions regarding dialysis modality decisions, namely that peritoneal dialysis is as effective a therapy as hemodialysis in patients returning to dialysis after kidney transplant failure." Study co-authors include Omar Hasan, MBBS (Brigham and Women's Hospital); Joanne Bargman, MD, S. Vanita Jassal, MD (University of Toronto, Canada); Depeng Jiang, PhD (Li Ka Shing Knowledge Institute and St. Michael's Hospital, University of Toronto, Canada); Yingbo Na (Canadian Institute of Health Information and Canadian Organ Replacement Register, in Toronto, Canada); and John Gill, MD (St. Paul's Hospital, University of British Columbia, in Vancouver, Canada) Journal Reference: 1. Jeffrey Perl et al. Impact of Dialysis Modality on Survival after Kidney Transplant Failure. Clinical Journal of the American Society Nephrology, January 13, 2011 DOI: 10.2215/CJN.06640810 American Society of Nephrology (2011, January 13). Dialysis at home is just as effective as in the clinic, study suggests. ScienceDaily. Retrieved December 4, 2012, from http://www.sciencedaily.com /releases/2011/01/110113213045.htm