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Chronic kidney disease may increase certain risks during pregnancy - NephrologyNews.com |
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Among pregnant women, the risk for adverse pregnancy outcomes—such as preterm delivery or the need for neonatal intensive care—increased across stages of chronic kidney disease.
The article, entitled “Risk of Adverse Pregnancy Outcomes in Women with CKD,” is published online at http://jasn.asnjournals.org/.
Even mild kidney disease during pregnancy may increase certain risks in the mother and baby, according to a study appearing in an upcoming issue of theJournal of the American Society of Nephrology. The findings may be helpful for guiding prenatal counseling and for monitoring women during pregnancy.
Chronic kidney disease is on the rise, and studies suggest that even early stages of the disease can affect pregnancy outcomes. An Italian research team led by Giorgina Barbara Piccoli, MD, Rossella Attini, MD, PhD (University of Torino), and Gianfranca Cabiddu, MD (Azienda Ospedaliera Brotzu) recently conducted a study—called the TOCOS (TOrino-Cagliari Observational Study)—that compared pregnancy outcomes of 504 pregnancies in women with CKD with outcomes of 836 low-risk pregnancies in women without CKD.
The researchers found that the risk for adverse pregnancy outcomes—such as preterm delivery, the need for neonatal intensive care, or the development of hypertension in the mother—increased across CKD stages. However, the risk was not merely linked to reduced kidney function because stage 1 CKD patients and healthy controls differed significantly, despite the fact that patients with stage 1 CKD are asymptomatic and have kidney function within the normal range. The team also found that the risks of intrauterine death or fetal malformations did not differ between patients and healthy controls.
“The findings indicate that any kidney disease—even the least severe, such as a kidney scar form a previous episode of kidney infection, with normal kidney function—has to be regarded as relevant in pregnancy, and all patients should undergo a particularly careful follow-up,” said Dr. Piccoli. “Conversely, we also found that a good outcome was possible in patients with advanced CKD, who are often discouraged to pursue pregnancy,” she added.
The investigators hope that the new findings may help establish dedicated programs for the early diagnosis and follow up of pregnancy in CKD. “We are presently working on a model for ‘grading’ the risks that will provide patients and physicians with information when making choices about undergoing and monitoring pregnancies,” said Dr. Piccoli.
Study co-authors include Federica Vigotti, MD, Stefania Maxia, MD, Nicola Lepori, MD, Milena Tuveri, MD, Marco Massidda, MD, Cecilia Marchi, MD, Silvia Mura, MD, Alessandra Coscia, MD, Marilisa Biolcati, PhD, Pietro Gaglioti, MD, Michele Nichelatti, PhD, Luciana Pibiri, MD, Giuseppe Chessa, MD, Antonello Pani, MD, and Tullia Todros, MD, PhD.
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MedPAC final report: no increase in dialysis payment rate for 2016 - NephrologyNews.com |
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Confirming an opinion released via a voice vote last month, the Medicare Payment Advisory Commission announced in its March written report to Congress that dialysis facilities did not need an increase in the bundled payment for 2016.
Specifically, “The Congress should eliminate the update to the outpatient dialysis payment rate for calendar year 2016.”
The report, one of two compiled each year by MedPAC that looks at Medicare programs and costs, includes a full chapter on dialysis care. In that chapter, the commission looks at access to care, the state of dialysis technology, the consolidation among dialysis providers, and other areas to determine if the industry needs an increase in Medicare payments.
When the dialysis bundle was established in 2011, it included a yearly review of costs of care. Called the “market basket,” the review, a hard fought victory for the renal community, determines if changes in technology and/or the dialysis marketplace would warrant in increase in the rate. But that review has been superseded over the last two years by a 12% rate cut for IV drug payments to dialysis clinics imposed by the Centers for Medicare & Medicaid Services. CMS imposed the rate cut after determining it had been paying too much for IV drugs within the bundled rate.
After legislation from Congress tempered the planned cut by CMS, it was agreed to apply any possible market basket review increases over multiple years to compensate for the cut.
'Costs have stabilized'
During a public meeting last Dec. 18, MedPAC presented a draft recommendation that Congress eliminate the update to the dialysis facility payment rate for calendar year 2016. MedPAC staff member Nancy Ray said at the time that eliminating the update would "lower spending relative to current law." She said that eliminating the payment update might put more financial pressure on dialysis providers, but said the commission does not "anticipate that it will impact [dialysis providers'] willingness or ability to furnish care. We do not anticipate this recommendation impacting beneficiaries."
In its final March report on dialysis care, MedPAC gave high marks to access to care and improvement in quality measures such as mortality. In looking at the cost of providing dialysis services vs. what providers were being paid, MedPAC said. “Our analysis of Medicare payments and costs is based on 2012 and 2013 claims and cost report data submitted to CMS by freestanding dialysis facilities. During this period, cost per treatment increased by 1%, while Medicare payment per treatment increased by about 1.5%. Taking into account the sequester, we estimate that the aggregate Medicare margin was 4.3% in 2013, and the projected Medicare margin is 2.4% in 2015. The evidence suggests that payments are adequate; the Commission judges that outpatient dialysis facilities can continue to provide beneficiaries with appropriate access to care with no update to the base payment rate in 2016.”
For the full MedPAC report, go to http://medpac.gov/documents/reports/march-2015-report-to-the-congress-medicare-payment-policy.pdf?sfvrsn=0
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Dialysis Patients At Higher Cancer Risk - Renal and Urology News |
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March 16, 2015
Over a 5-year period, cancer developed in 9.5% of hemodialysis patients, a rate much higher than would be expected in the general population.
Dialysis patients with ESRD are uniquely at risk for developing cancer, according to researchers.
Patients with end-stage renal disease (ESRD) receiving hemodialysis have an added burden: high rates of cancer, according to a new study.
Anne M. Butler, PhD, and colleagues from the University of North Carolina at Chapel Hill calculated cancer incidence rates for almost a half million adults in Medicare's ESRD program who received dialysis therapy between 1996 and 2009.
According to results published online ahead of print in the American Journal of Kidney Diseases, the investigators observed a constant rate of cancers in patients, from 3,923 to 3,860 cases per 100,000 persons per year. Over 13 years, the rate of kidney cancer rose, while the rates of other cancers, such as colon and lung, declined.
The 5-year cumulative incidence of any cancer was 9.48%, much higher than the incidence that would be expected in the general population. The risk for kidney cancer was 4 times higher and bladder cancer was 1.5 times higher.
“These results suggest that patients with ESRD are uniquely at risk for developing cancer while receiving hemodialysis treatment,” the researchers stated.
Cancer incidence was higher for certain patients: seniors, men, non-Caucasian and non-Hispanic ethnicities, people without diabetes, new dialysis patients, and transplant candidates.
The investigators suggest several possible explanations for the higher cancer rates among dialysis patients, including ESRD-associated immunodeficiency and nutritional abnormalities. In addition, uremic and dialysis-induced immune dysfunction may interact with cancer risk factors such as tobacco.
“Our findings of differential cancer incidence among certain subgroups highlight the need to potentially reevaluate target cancer screening practices. Furthermore, targeted screening for certain cancer types should be considered,” the researchers stated.
Source
- Butler, AM, et al. AJKD; doi: 10.1053/j.ajkd.2014.12.013.
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Study shows injured kidneys can be used for transplants - NephrologyNews.com |
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A new study led by researchers at Yale finds that kidneys from deceased donors who had acute injuries may be more viable than previously thought, and should be considered to meet the growing demand for organ transplants.
Donated kidneys with acute injury are often discarded for fear of poor outcomes such as delayed function and even premature kidney transplant failure. Given the growing need for transplant organs, the researchers embarked on the largest multicenter observational study of its kind to date, including more than 1,600 deceased donors. They examined associations between acute kidney injury in donors, rates of kidney discard, and recipient kidney function in the short term as well as six months after transplantation.
As anticipated, the researchers found an association between AKI and organ discard. They also found that injured kidneys were associated with "delayed graft function (DGF)," or the need for continued dialysis support in the first week after transplantation. But unexpectedly, the study did not find a link between deceased-donor kidney injury and poor kidney transplant function six months later.
"What we saw was, with worsening AKI in the donor, the six-month outcome was actually better for recipients who experienced DGF," said Isaac E. Hall, M.D., investigator in the Program of Applied Translational Research at Yale School of Medicine and first author of the study.
Six-month transplant function was worst for those with delayed graft function who had received a donated kidney with no apparent injury.
Hall suggested that organs acutely injured in the donor might develop "ischemic preconditioning," a mechanism that could protect the organs from the effects of subsequent injury. Another possible explanation is that the successfully transplanted kidneys with AKI were of otherwise higher quality than the rejected kidneys with AKI, though the study did adjust for many important variables like donor age and comorbidity.
"There appears to be room to attempt more transplants using these AKI kidneys rather than throwing them away," said Chirag R. Parikh, M.D., director of the Program of Applied Translational Research and senior author of the study. "Even if it only means a few dozen more kidney transplants each year, those are patients who would come off of the waiting list for transplants sooner and have much better survival than continuing on dialysis in hopes of seemingly higher-quality kidney offers, which may never come in time," he said.
The study was published March 11 in the American Journal of Transplantation.
Other authors include Bernd Shröppel, Mona D. Doshi, Joseph Ficek, Francis L. Weng, Rick D. Hasz, Heather Thiessen-Philbrook, and Peter P. Reese.
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NxStage to Present Abstract on Home Nocturnal Therapy with System One at ... - CNNMoney |
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LAWRENCE, Mass., March 16, 2015 /PRNewswire/ -- NxStage Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of dialysis products, today announced a late breaking abstract, "Home Nocturnal Hemodialysis with Low Dialysate Volume: A Cross-Over Study," outlining favorable outcomes for more frequent home hemodialysis patients who transitioned to home nocturnal hemodialysis with the NxStage® System One?. The National Kidney Foundation accepted the abstract for poster presentation during its 2015 Spring Clinical Meeting in Dallas, Texas.
Results from this study, conducted by nephrologists Brigitte Schiller, M.D. and Brent W. Miller, M.D., supported the Food and Drug Administration's (FDA) recent clearance of the NxStage System One to perform therapy overnight while patients are at home sleeping, known commonly as nocturnal therapy. The Company's System One is the first and only hemodialysis machine cleared by the FDA for this indication.
"This study demonstrates that at-home, overnight hemodialysis is both safe and effective for ESRD patients, and can help them live a full life," said Brigitte Schiller, M.D., Chief Medical Officer of Satellite Healthcare and Principal Investigator of NxStage's home nocturnal hemodialysis trial. "Now that the FDA has cleared the NxStage System One for nocturnal therapy, I am even more committed to furthering the conversation on nocturnal therapy and the incredible benefits it can offer to our patients' health and quality of life."
This poster presentation will take place on Thursday, March 26, 2015 from 6:00 -7:30pm at the Gaylord Texan, and will remain on display through Saturday, March 28, 2015.
Despite the health benefits that home hemodialysis may provide to those with chronic kidney disease, this form of therapy is not for everyone. The reported benefits of home hemodialysis may not be experienced by all patients. The risks associated with hemodialysis treatments in any environment include, but are not limited to, high blood pressure, fluid overload, low blood pressure, heart-related issues, and vascular access complications. The medical devices used in hemodialysis therapies may add additional risks including air entering the bloodstream and blood loss due to clotting or accidental disconnection of the blood tubing set. Certain risks are unique to the home. Treatments at home are done without the presence of medical personnel and on-site technical support. Patients and their partners must be trained on what to do and how to get medical or technical help if needed.
Additional Risks Associated with Nocturnal Home Hemodialysis Therapy
The NxStage System One may be used at night while the patient and care partner are sleeping. Certain risks associated with hemodialysis treatment are increased when performing nocturnal therapy due to the length of treatment time and because therapy is performed while the patient and care partner are sleeping. These risks include, but are not limited to, blood access disconnects and blood loss during sleep, blood clotting due to slower blood flow or increased treatment time or both, and delayed response to alarms when waking from sleep. Ancillary anticoagulant infusion pumps and fluid leak detection devices may be used to decrease certain risks for home hemodialysis treatments performed at any time, but NxStage requires the use of fluid leak detectors to identify leaks from the vascular access, Cycler and Cartridge when performing nocturnal therapy with the NxStage System One.
About the NxStage System One
The NxStage System One is the first and only truly portable hemodialysis system cleared specifically by the FDA for home hemodialysis and home nocturnal hemodialysis. Its simplicity and revolutionary size (just over a foot tall) are intended to allow convenient use in patients' homes and give patients the freedom to travel with their therapy. When combined with the NxStage PureFlow SL Dialysis Preparation System, patients are able to further simplify, using ordinary tap water to create dialysis fluid on demand. Unlike conventional hemodialysis systems, the System One requires no special infrastructure to operate. Under the guidance of their physician, patients can use the NxStage System One, with their trained partners, where, how and when it best meets their needs, including while they are sleeping - at home or on vacation and at a medically appropriate treatment frequency. http://www.nxstage.com/.
About NxStage Medical
NxStage Medical Inc. (Nasdaq: NXTM) is a medical device company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative products for the treatment of ESRD and acute kidney failure. For more information on NxStage and its products, please visit the Company's website at www.nxstage.com.
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this release that are not clearly historical in nature are forward-looking, and the words "anticipate," "believe," "expect," "estimate," "plan," and similar expressions are generally intended to identify forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those that are discussed in NxStage's filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2014. NxStage is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Media contact:
Kristen K. Sheppard, Esq.
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Tel: (978) 332-5923
Logo - http://photos.prnewswire.com/prnh/20110503/MM94799LOGO
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/nxstage-to-present-abstract-on-home-nocturnal-therapy-with-system-one-at-nkf-2015-spring-clinical-meeting-300050665.html
SOURCE NxStage Medical Inc.
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