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SCAI 2015 | Feature - Physician's Weekly PDF Print

New research was presented at SCAI 2015, the annual scientific sessions of the Society for Cardiovascular Angiography and Interventions, from May 6 to 9 in San Diego. The features below highlight some of the studies that emerged from the conference.

Mechanical Circulatory Support for STEMI

The Particulars:Although mechanical circulatory support (MCS) is often used in patients with cardiogenic shock after STEMI, studies on its efficacy have revealed conflicting results.

Data Breakdown:For a study, researchers analyzed more than 35,000 inpatient admissions with a principal diagnosis of STEMI that required MCS between 2003 and 2011. Use of MCS increased significantly during the study period. This increase was accompanied by a significant rise in the incidence of cardiogenic shock. Among patients with cardiogenic shock, those treated with MCS had an in-hospital mortality rate of 31.2%, compared with a rate of 39.4% observed in those treated without MCS.

Take Home Pearls:Use of MCS in patients with STEMI appears to have increased significantly in recent years. The approach appears to significantly reduce in-hospital mortality when compared with providing treatment without MCS.

Infra-Inguinal Percutaneous Vascular Stenting Vs Angioplasty

The Particulars:Few studies have explored outcomes following infra-inguinal percutaneous vascular stenting in recent years or compared these outcomes with those of angioplasty.

Data Breakdown:Study investigators used a national database to identify angioplasties or infra-inguinal procedures using a bare metal stent (BMS) or drug-eluting stent (DES) performed in adults between 2006 and 2011. Amputation rates were significantly lower in DES and BMS cases when compared with angioplasty cases. In-hospital mortality rates were similar for all procedures. However, DES and BMS use significantly reduced the mortality rate and risk for post-procedural complications.

Take Home Pearl:Infra-inguinal percutaneous vascular stenting appears to decrease rates of amputation as well as mortality and post-procedural complications when compared with angioplasty.

LOS & Long-Term Mortality After STEMI

The Particulars: Research shows that there has been a significant reduction in hospital length of stay (LOS) among patients undergoing PCI for STEMI over the past few decades. Predictors of long LOS after STEMI have been assessed in previous studies, but have not clearly established the association between LOS and long-term outcomes after PCI.

Data Breakdown:Long-term mortality and LOS were assessed in a study of nearly 2,000 patients who underwent PCI for STEMI between 2002 and 2011. Researchers observed a significant rise in long-term mortality as LOS increased among those who survived their index hospitalization. Patients with an LOS of 3 to 5 days had a significantly higher rate of mortality than patients with an LOS of 1 to 2 days.

Take Home Pearls:Patients who require a longer hospital stay after PCI for STEMI appear to have a higher mortality risk. The authors note that these patients may benefit from close, frequent follow-up management.

Serum Uric Acid Predicts Post-AMI Mortality

The Particulars:Previous studies have found that high levels of serum uric acid appear to be an independent risk factor for cardiovascular morbidity and mortality, particularly in patients with heart failure and atrial fibrillation. Less is known about the relationship between serum uric acid levels and in-hospital mortality among patients with acute myocardial infarction (AMI).

Data Breakdown:For a study, patients with AMI were divided into those with an in-hospital mortality and those who survived the AMI. Patients who died in the hospital had higher serum uric acid levels than those who did not die. Serum uric acid levels, left ventricular ejection fraction, and systolic blood pressure were all independently associated with in-hospital mortality in the study population.

Take Home Pearls:Measuring serum uric acid may be a low-cost, simple approach to assessing in-hospital mortality risk among patients with AMI. Further research is needed to determine whether high serum uric acid levels are a consequence of oxidative damage and inflammation in this patient population.

Comparing Revascularization Strategies in ESRD Patients

The Particulars:Coronary artery disease has been identified as a major cause of mortality in patients with end-stage renal disease (ESRD) patients who are on hemodialysis. Despite this knowledge, data are lacking on the optimal revascularization strategy for these patients.

Data Breakdown:A systematic review and meta-analysis was conducted and involved 24 studies that evaluated the early and late outcomes of PCI and CABG in ESRD patients who were on hemodialysis. During early follow-up, PCI was shown to have favorable outcomes in this patient population when compared with CABG. However, CABG was associated with a lower risk of later-stage mortality when compared with PCI.

Take Home Pearls:Among ESRD patients on hemodialysis, CABG appears to have a superior long-term mortality rate when compared with PCI. However, short-term outcomes for this patient group appear to be worse for CABG recipients than for those receiving PCI.

For more information on these studies and others that were presented at SCAI 2015, go to www.scai.org/SCAI2015.

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Smoking is Risk Factor for Certain Renal Cell Carcinoma Subtypes - Cancer Therapy Advisor PDF Print
August 12, 2015 Smoking is Risk Factor for Certain Renal Cell Carcinoma Subtypes - Cancer Therapy Advisor
Smoking is a risk factor in the clear cell and papillary subtypes of renal cell carcinoma, but not in chromophobe RCC.

Smoking is a risk factor in the clear cell and papillary subtypes of renal cell carcinoma (RCC), but not in chromophobe RCC, according to a study published in The Journal of Urology.

Neel Patel, MD, and fellow researchers from the Roswell Park Cancer Institute in Buffalo, NY, collected smoking data and retrospectively assessed 816 patients with nonfamilial RCC or benign pathology who had undergone nephrectomy at a National Comprehensive Cancer Network treatment center, seeking to find an association with histological diagnosis.

Among those patients, 21% were active smokers and 30% were former smokers.

Active smoking was found to be more common among those with clear cell (23 percent) or papillary (26 percent) RCC compared to those with benign histology (14 percent each) or chromophobe RCC (6 percent).

Smoking history – both active and former – was generally found to be uncommon in chromophobe RCC (26 percent) compared to clear cell (53 percent) or papillary (58 percent). In addition, smoking extent based on mean pack-years was significantly lower in chromophobe RCC (9.4 mean pack-years) compared to clear cell (15.3 mean pack-years) or papillary (15.2 mean pack-years).

RELATED: Modified 2/1 Sunitinib Schedule May Be Safer in Renal Cell Carcinoma

Upon propensity analyses, both clear cell and papillary RCC were found to be independently associated with active smoking, but not chromophobe RCC.

“These findings underscore distinct carcinogenic mechanisms underlying the various RCC subtypes,” the authors concluded.

Reference

  1. Patel NH, Attwood KM, Hanzly M, et al. Comparative analysis of smoking as a risk factor among renal cell carcinoma histological subtypes. 2015. The Journal of Urology. [online ahead of print]. doi: 10.1016/j.juro.2015.03.125. 

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Poke-Proof Grafts Could be Life-Changing for Dialysis Patients - Duke Today PDF Print
Poke-Proof Grafts Could be Life-Changing for Dialysis Patients - Duke Today August 12, 2015

Editor’s Note: This is the third in a series of articles exploring partnerships between basic scientists and clinicians supported by the Duke CTSA through the Duke Translational Research Institute (DTRI) Collaborative Pilot Agreements.

 

People with end-stage kidney failure depend for their very life on connecting their bloodstream to a dialysis machine several times a week. Each time, all of the blood is pumped out of the body and into a blood-cleansing machine that filters the blood before circulating it back into their body over a period of about four hours. The success of this life-saving procedure depends on a hollow tube implanted under the skin—an arteriovenous graft—which provides ready access to the bloodstream.

The "Bullet Proof" self-sealing graft
The Bullt Proof graft includes two
penetration-resistant chambers to
eliminate needles neadlessly damaging
the soft tubing used in dialysis. 

But, as Roberto Manson, a researcher in Duke’s Department of Surgery, explains, the hollow tube that allows the procedure has a big problem. Needle pokes.

The problem with standard grafts is that manufacturers make them primarily to ensure a strong blood flow through the conduit. They aren’t made to withstand the regular needle pokes that dialysis requires. It’s very easy for dialysis professionals to inadvertently poke the needle straight through one side of the graft and out the other. As a result, patients on dialysis often suffer painful bruising and infections from arteriovenous graft injuries and related complications.

After studying the problem, Manson and his teammates have an answer. Poke-proof grafts with self-sealing capabilities.

With funding from the Duke CTSA through the Duke Translational Research Institute (DTRI) Collaborative Pilot Award, Manson, Duke vascular surgeon Jeffrey Lawson, and senior vascular physician assistant Shawn Gage aim to get this game-changing medical device out to patients within a year. Gage, co-inventor and lead developer of the technology, has been working with a local engineering and design firm, Gilero Biomedical, to conceptualize and create this immediate use, error proof, dialysis graft.

Lawson and Gage spend a good part of their time in the operating room implanting new grafts and correcting those that have failed. In a conference room on the fourth floor of Duke’s Medical Sciences Research Building, Lawson flips through a series of gruesome images on his computer screen that illustrate just how miserable graft failures are for kidney disease patients. It’s also costly. Arteriovenous graft injuries and complications are responsible for millions of dollars in health care expenditures every year.

“It costs $50,000 every time this happens,” Lawson said. “It’s expensive, painful, and I think unnecessary.”

That line of thinking has led Lawson and others to search for solutions. “That’s the nature of invention,” Lawson said. “You get sick of something failing over and over again and you think there has to be a better way to do this.”


Lawson, Manson and Gage hold the latest
 prototype of the "Bullet Proof" graft. 
Photo by Marsha A. Green, DTMI

Lawson, Manson, and Gage, appear to have found that better way.

Their device, called Bullet Proof ™, is surprisingly simple. Over most of its length, their new graft is identical to those that are standardly used. But Bullet Proof has two penetration-resistant chambers—one for the needle that sends blood out of the body and the other for the needle that sends the blood back in again—each built with a window of material that seals itself after each needle poke. Along the back of the tube is a rigid plate that makes it impossible for a needle to go straight through the graft. Lawson likes to illustrate this by pushing a needle in and showing how it bends rather than poking through.

The Duke team has already fabricated simple prototypes of their new device and launched a company called InnAVasc (http://innavasc.com) with the goal to develop their graft into a marketable product. With funding from the Duke CTSA through the Duke Translational Research Institute (DTRI) Collaborative Pilot Award, they are working to finalize their device design and conduct tests of Bullet Proof to further demonstrate the puncture resistant and self-sealing capabilities in the laboratory.

The investigators are implanting the grafts into pigs to see how well they really work in a living, breathing animal. After a poke of a standard graft, there is considerable bleeding. Dialysis professionals typically must apply pressure for some time before the bleeding stops. In animal tests, it appears as though Bullet Proof grafts result in little more than a trickle of blood as their walls seal themselves back up. As a result, the tissue around a Bullet Proof graft doesn’t show the inflammation and injury that’s typical in dialysis patients today.

In animal tests, it appears as though Bullet Proof grafts result in little more than a trickle of blood as their walls seal themselves back up. As a result, the tissue around a Bullet Proof graft doesn’t show the inflammation and injury that’s typical in dialysis patients today.

The Bullet Proof concept and device is getting great reviews. In April, the Duke team won the CX Innovation Showcase held in London, which is dedicated to vascular and endovascular innovation. Manson and Lawson say they’ve already spoken with the FDA and are working on a package to present to them in hopes of testing the new device in patients as soon as possible. If they can secure enough funding to proceed to a final, medical-grade product, they hope to begin implanting the first Bullet Proof grafts into people within a year.

That’s promising news for dialysis patients and for the doctors and nurses who care for them. Gage says that Bullet Proof might even enable some patients to begin undergoing dialysis in the comfort of their own homes.

“We think this can save the health system money and patients from misery,” Lawson said. “The idea just makes common sense and the DTRI award is important in providing financial support to push it forward.”

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NxStage System One Now in Eight of Top 10 US Nephrology Hospitals - MarketWatch PDF Print


                  LAWRENCE, Mass., Aug. 12, 2015 /PRNewswire/ -- NxStage Medical, Inc. 

                            
                            
                                  
      
      
      
      
      
      
      
                                  
                                    NXTM, +3.67%

                            
                                  
      
      
      
      
      
      
      
                                         a leading manufacturer of dialysis products, today announced that the NxStage® System One™ is now used in eight of the Top 10 Nephrology Hospitals in the United States as ranked according to U.S. News & World Report. The Company's revolutionary System One simplifies care in acute settings and allows renal care professionals to deliver the prescribed renal replacement therapy via a variety of modalities to critically ill patients.


                  The System One offers multiple features designed to simplify therapies in hospitals. These features include the NxView interface with graphical touch screen display that provides treatment information and charting assistance, a drop-in cartridge that allows multiple therapies, no waste bags, and no special electrical or plumbing needs.


                  "We're honored to be a partner to these prestigious hospitals, and we look forward to continued close collaboration as we deliver future innovations to patient care," said Joseph E. Turk, President of NxStage.


                  For more information about the NxStage System One, renal replacement therapies or home hemodialysis, please visit www.nxstage.com.


                  
        Renal replacement therapy, as with any medical therapy, is not without risks. The decision of which therapy to use should be made by the physician, based on previous experience and on the individual facts and circumstances of the patient.  
      

                  
        About the NxStage System OneThe System One is used to provide a range of flexible therapy options in hospitals and dialysis centers.  The NxStage System One is also 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. Its safety and efficacy have been demonstrated by experience with more than 10 million treatments with thousands of patients around the world. http://www.nxstage.com/.


                  
        About NxStage MedicalNxStage 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 StatementsThis 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2015. 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.
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Tel: (978) 332-5923   Logo - http://photos.prnewswire.com/prnh/20110503/MM94799LOGO Logo - http://photos.prnewswire.com/prnh/20150624/225341 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/nxstage-system-one-now-in-eight-of-top-10-us-nephrology-hospitals-300127263.html SOURCE NxStage Medical, Inc. Copyright (C) 2015 PR Newswire. All rights reserved

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Only 1 in 4 patients with ESRD in Georgia referred for kidney transplant ... - News-Medical.net PDF Print

Only about one in four patients with end-stage renal disease in Georgia were referred for kidney transplant evaluation within 1 year of starting dialysis between 2005 and 2011, although there was substantial variability in referral among dialysis facilities, according to a study in the August 11 issue of JAMA.

For most of the more than 600,000 patients in the United States with end-stage renal disease (ESRD), kidney transplantation represents the optimal treatment, providing longer survival, better quality of life, and substantial cost savings compared with dialysis. Dialysis facilities in the United States are required to educate patients with ESRD about all treatment options, including kidney transplantation. Patients receiving dialysis typically require a referral for kidney transplant evaluation at a transplant center to begin the transplantation process, but the proportion of dialysis patients referred for transplantation has been unknown, according to background information in the article.

Rachel E. Patzer, Ph.D., M.P.H., of the Emory University School of Medicine, Atlanta, and colleagues examined variation in dialysis facility-level referral for kidney transplant evaluation and factors associated with referral among patients initiating dialysis in Georgia, the U.S. state with the lowest kidney transplantation rates. The study included data from the United States Renal Data System for 15,279 adult (18-69 years) patients with ESRD from 308 Georgia dialysis facilities from January 2005 to September 2011, followed up through September 2012, and linked to kidney transplant referral data collected from adult transplant centers in Georgia in the same period.

The median within-facility percentage of patients referred within 1 year of starting dialysis at 308 Georgia dialysis facilities was 24 percent. There were 15 facilities (5 percent) that referred zero patients within 1 year of starting dialysis; the maximum referral in a year was 75 percent. Facilities in the lowest tertile of referral (<19 percent) were more likely to treat patients living in high-poverty neighborhoods, had a higher patient to social worker ratio, and were more likely nonprofit compared with facilities in the highest tertile of referral (>31 percent).

Factors associated with lower referral for transplantation, such as white race, older age, and nonprofit facility status, were not necessarily the same as those associated with lower waitlisting, the researchers write. "Results of this study suggest that referral for transplantation among Georgia dialysis facilities is not uniform and that national surveillance data measuring waitlisting and transplantation, but not referral, may be inadequate to assess and intervene on disparities in access to kidney transplantation."

"These findings may have implications for health policy makers, researchers, clinicians, and patients. Low facility-level referral for transplantation, as well as the variability in referral across Georgia facilities, suggests that standardized guidelines are needed for the content and duration of a patient-clinician educational discussion regarding treatment options at start of dialysis. Socioeconomic status factors were significant barriers to both referral and waitlisting in this study; national policies, such as Medicaid expansion, could help to alleviate disparities," the authors write.

"Researchers should continue to develop, test, and implement pragmatic interventions to improve knowledge of transplantation among both clinicians and patients. In Georgia, such interventions could focus on those dialysis facilities with the lowest proportions of patients with ESRD referred for kidney transplantation."

"In summary, this important report by Patzer et al has established that major barriers in access to transplantation exist even after a patient has been referred to a transplant center, with 80 percent of referred patients not joining the transplant waitlist within 1 year of referral," writes Dorry L. Segev, M.D., Ph.D., and colleagues with the Johns Hopkins University School of Medicine, Baltimore, in an accompanying editorial.

"Furthermore, the initial rates of referral were likely low and varied widely between dialysis centers, suggesting that some facilities may have been underreferring patients. Future research to better understand and target post-referral barriers, as well as interventions to identify and improve referral rates in the context of comprehensive transplant education, will be crucial for improving access to kidney transplantation for patients with ESRD."

The JAMA Network Journals

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