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Hemodialysis.com Hemodialysis research, author interviews, dialysis updates and information on chronic kidney disease and end stage renal failure. Editor: Marie Benz, MD [email protected] March 9 2013 For Informational Purposes Only: Not for Specific Medical Advice. Read more interviews on Hemodialysis.com For Informational Purposes Only. Not for Specific Medical Advice

Hemodialysis Nephrology Interviews March 9 2013

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Hemodialysis.com

Hemodialysis research, author interviews, dialysis updates and information on chronic kidney disease and end stage renal failure.

Editor: Marie Benz, [email protected]

March 9 2013

For Informational Purposes Only: Not for Specific Medical Advice.

For Informational Purposes Only. Not for Specific Medical Advice

Page 2: Hemodialysis Nephrology Interviews March 9 2013

Read more interviews on Hemodialysis.com

Hemodialysis.com InterviewsMarch 9 2013

For Informational Purposes Only. Not for Specific Medical Advice

Page 3: Hemodialysis Nephrology Interviews March 9 2013

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For Informational Purposes Only. Not for Specific Medical Advice

Page 4: Hemodialysis Nephrology Interviews March 9 2013

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Lethal cardiac arrhythmia during central venous catheterization in a uremic patientHemodialysis.com Interview with Jer-Ming Chang. MD. PhDSecretary for the Superintendant, andAttending physician, Department of Internal Medicine

Kaohsiung Municipal Hsiao-Kang Hospital Kaohsiung 807, Taiwan

• Hemodialysis.com: What are the main findings of the study?• Dr. Chang: Cardiac arrhythmia induced during the procedure of central vein catheterization might be

more common than expected, especially in high-risk CKD patients (pre-existing CV diseases, electrolytes disturbances…).Continuous monitoring during procedure is recommended for safety.

• Hemodialysis.com: Were any of the findings unexpected?• Dr. Chang: Most of these unexpected arrhythmic events can be salvaged properly, unless unnoticed.• Hemodialysis.com: What should clinicians and patients take away from your report?• Dr. Chang: Before catheterization for CKD patients, clinicians are suggested to access the risk of

arrhythmia and patients are equally responsible for revealing detailed information in this respect.• Hemodialysis.com: What recommendations do you have for future research as a result of this study?• Dr. Chang: Unfortunately this is an undisputable safety issue and may not be suitable for study.• Citation:• Lethal cardiac arrhythmia during central venous catheterization in a uremic patient: A case report and

review of the literature• Huang, Y.-C., Huang, J.-C., Chen, S.-C., Chang, J.-M. and Chen, H.-C. (2013), Hemodialysis International.

doi: 10.1111/hdi.12030

For Informational Purposes Only. Not for Specific Medical Advice

Page 5: Hemodialysis Nephrology Interviews March 9 2013

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Effective elimination of dabigatran by haemodialysis. A phase I single-centre study in patients with end-stage renal diseaseHemodialysis.com Interview with Prof. Dr. med. Harm PetersProjektsteuerung Modellstudiengang Medizin &Nephrologie Charité

Universitätsmedizin Berlin, Campus Charité Mitte 10117 Berlin

• Hemodialysis.com: What are the main findings of the study?

• Dr. Peters: The four key findings from our study are as follows:• 1) in ESRD patients, a specific dosing regimen (150 mg on Day 1, 110 mg on Day 2 and 75 mg on Day 3) yielded

peak dabigatran plasma concentrations on Day 3 comparable to those observed in AF patients with atrial fibrillation in RE-LY dosed with 150 mg b.i.d.; however, it could not be considered as a suitable treatment regimen for ESRD patients undergoing regular HD and who are in need of regular anticoagulation.

• 2) a single 4-hour hemodialysis session removed 48.8% of plasma dabigatran at a blood flow rate of 200 ml/min and 59.3% at blood flow rates of 350-395 ml/min;

• 3) the anticoagulant activity of dabigatran was reduced proportionally to the hemodialysis-related reduction in plasma levels;

• 4) a minor redistribution of dabigatran (7.5-15%) into the plasma compartment was noted after the end of dialysis.

• Hemodialysis.com: Were any of the findings unexpected?• Dr. Peters: The previous study from Stangier J et al. included six patients with end-stage renal failure who were

given a single 50 mg dose of dabigatran at the commencement of a 4 hour hemodialysis session. There was elimination rate of 62-68% of dabigatran observed. Thus, the findings of our study are not unexpected.

• However, the study of Stangier et al did not reveal the fraction of dabigatran cleared from the plasma. More over there was not clear whether the hemodialysis session would be able to effectively reduce the dabigatran in concentration comparable to those observed in patients with atrial fibrillation dosed with 150 mg twice daily.

For Informational Purposes Only. Not for Specific Medical Advice

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Effective elimination of dabigatran by haemodialysis. A phase I single-centre study in patients with end-stage renal diseaseHemodialysis.com Interview with Prof. Dr. med. Harm PetersProjektsteuerung Modellstudiengang Medizin &

Nephrologie Charité Universitätsmedizin Berlin, Campus Charité Mitte 10117 Berlin(cont)

• Hemodialysis.com: What should clinicians and patients take away from your report?• Dr. Peters: A 4-hour hemodialysis session can rapidly eliminate at least half of the dabigatran in the central

compartment with an important reduction in its anticoagulant activity. This is important because there is currently no available antidote to reverse the anticoagulant effects of dabigatran, which is being increasingly used globally. Patients taking and physicians prescribing dabigatran can be aware there is a method to potentially reduce its anticoagulant effects in critical situations.

• Hemodialysis.com: What recommendations do you have for future research as a result of this study?• Dr. Peters: Based on the available data no final assessment can be made if this magnitude of redistribution

might change once extreme (e.g. accidental or suicidal) supra-therapeutic plasma concentrations are present after multiple dosing. Besides the study population consisted of clinical stable patients with relatively few co-morbidities other than their ESRD and its expected consequences. Thus, the therapeutic benefit of dialysis still requires confirmation in patients with bleeding complications or other emergency situations.

• Citation:• Effective elimination of dabigatran by haemodialysis. A phase I single-centre study in patients with end-

stage renal disease• Harm Peters, MD, Department of Nephrology, Charité – Universitätsmedizin Berlin, Humboldt University,

Charitéplatz 1, 10117 Berlin, Germany, Tel.: +49 30 450 514072, Fax: +49 30 450 514902• Khadzhynov D, Wagner F, Formella S, Wiegert E, Moschetti V, Slowinski T, Neumayer HH, Liesenfeld KH, Lehr T,

Härtter S, Friedman J, Peters H, Clemens A.• Thromb Haemost. 2013 Feb 7;109(4). [Epub ahead of print]

For Informational Purposes Only. Not for Specific Medical Advice

Page 7: Hemodialysis Nephrology Interviews March 9 2013

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Pharmacologic Therapy for Primary Restless Legs SyndromeHemodialysis.com Author Interview: Timothy J. Wilt, MD, MPHProfessor of Medicine and Core InvestigatorMinneapolis VA Center for Chronic Disease Outcomes Research and

the University of Minnesota School of MedicineMinneapolis, MN 55417

• Hemodialysis.com: What are the main findings of your study?

• Dr. Fink: Our systematic review of randomized controlled trials found that in patients with long-term Restless Legs Syndrome (RLS) that is at least moderately bothersome, treatment with certain medications (dopamine agonists [rotigotine, pramipexole, ropinorole] and calcium channel alpha-2-delta ligands [gabapentin enacarbil, pregabalin, or gabapentin]) can reduce RLS symptoms and improve sleep and quality of life at least in the short term.

• However, side effects including somnolence, nausea, skin application site reactions, worsening of symptoms (augmentation) and treatment withdrawals due to side effects are common.

Hemodialysis.com Were any of the findings unexpected?

• Dr. Fink: We were surprised by the almost total lack of evidence directly comparing different medications or comparing medications to nonpharmacologic therapies such as exercise, massage, hot baths etc.

• Furthermore, we were disappointed by the lack of information on the effectiveness and harms of treatments in pregnant women, young or old patients, those with milder symptoms or with other serious medical conditions including chronic kidney disease or undergoing dialysis. The latter is particularly important because RLS is common and bothersome in patients undergoing dialysis yet pharmacologic therapies may have different benefits and harms in these individuals.

• Until high quality studies are done we urge caution in extending our conclusions to these individuals. Additionally, we found no good scientific information on the effectiveness of other commonly used treatments including nonpharmacologic treatments as well as opioids or hypnotics that are not FDA approved for this indication and have the potential for abuse especially given the large placebo effect seen in the studies.

For Informational Purposes Only. Not for Specific Medical Advice

Page 8: Hemodialysis Nephrology Interviews March 9 2013

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Pharmacologic Therapy for Primary Restless Legs SyndromeHemodialysis.com Author Interview: Timothy J. Wilt, MD, MPHProfessor of Medicine and Core Investigator

Minneapolis VA Center for Chronic Disease Outcomes Research and the University of Minnesota School of MedicineMinneapolis, MN 55417 (cont)

• Hemodialysis.com: What should clinicians and patients take away from your report?• Dr. Fink: Patients should inform their physician if they have bothersome sensations in their legs that includes

distressing, irresistible urge to move them that is relieved by rest. This may be due to RLS but may be due to other conditions.

• An accurate diagnosis is important. Effective treatments for RLS are available and in patients with more severe symptoms may include medications. Physicians and patients now have up to date information on the effectiveness and harms of drug treatments for patients with at least moderately severe RLS symptoms in which to guide treatment choices. There are no high quality data on patients with less severe symptoms or and little information on nonpharmacologic therapies.

• The decision to initiate pharmaocologic treatment in patients with bothersome symptoms should be based on patient and provider assessment of the balance of these benefits and harms.

• Hemodialysis.com: What recommendations do you have for future research as a result of this study?• Dr. Fink: Future randomized controlled and open label extension trials are needed to directly evaluate the long-term

comparative effectiveness of different treatment approaches and in patients with milder symptoms and among younger or older patients or those with underlying comorbid conditions especially chronic kidney disease.

• Research is also needed to assess treatments commonly used but not evaluated including opioids, benzodiazepams and nonpharmacologic interventions.

• Citation: • Pharmacologic Therapy for Primary Restless Legs SyndromeA Systematic Review and Meta-analysis• Wilt TJ, MacDonald R, Ouellette J, et al.

JAMA Intern Med. 2013;():1-10.doi:10.1001/jamainternmed.2013.3733.

For Informational Purposes Only. Not for Specific Medical Advice

Page 9: Hemodialysis Nephrology Interviews March 9 2013

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Pulmonary Congestion Predicts Cardiac Events and Mortality in ESRDHemodialysis.com Author Interview: Dr. Carmine Zoccali CNR-IBIMNephrology, Dialysis and Transplantation Unit, and CNR-IBIM,

Clinical Epidemiology and Pathophysiologyof Renal Diseases and HypertensionReggio Calabria, Italy

• Hemodialysis.com: Explain why you believe this research is especially important.

• Dr. Zoccali: In this study we measured the degree of lung congestion in dialysis patients by a novel, very simple, inexpensive technique, i.e. lung ultrasound (US).

• We found that asymptomatic dialysis patients frequently have substantial accumulation of water in the lungs (subclinical pulmonary edema). Importantly, lung water by US was a better predictor of the risk of death and cardiac events than symptoms of heart failure as assessed by the NYHA score. The prognostic value of subclinical lung edema was independent of classical risk factors and risk factors associated with CKD like low serum albumin, hyperphosphatemia and high CRP. Thus, detection of subclinical pulmonary edema is useful for prognosis in dialysis patients. More importantly, our findings generate the hypothesis that targeting subclinical pulmonary edema may improve cardiovascular disease and reduce death risk in the dialysis population, a population at an extremely high death risk.

• Hemodialysis.com: Explain what you were hoping to accomplish through your research. Was this possible? What did you actually discover?

• Dr. Zoccali: As said, we found that subclinical lung edema is quite common in dialysis patients and that this alteration is strongly associated with risk of death and cardiovascular events. Fluid subtraction with longer and/or more frequent dialyses may reduce lung congestion. Therefore, our findings represent a solid rationale for testing a clinical policy based on the detection of subclinical lung edema to tailor dialysis treatment.

• Hemodialysis.com: Include below any information about the topic that would appeal to the medical and consumer media. Please remember that the consumer media may not understand certain medical terms, so try to simplify your information as though you were talking to your next-door neighbor.

For Informational Purposes Only. Not for Specific Medical Advice

Page 10: Hemodialysis Nephrology Interviews March 9 2013

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Pulmonary Congestion Predicts Cardiac Events and Mortality in ESRDHemodialysis.com Author Interview: Dr. Carmine Zoccali CNR-IBIMNephrology, Dialysis and Transplantation Unit, and CNR-IBIM,

Clinical Epidemiology and Pathophysiologyof Renal Diseases and HypertensionReggio Calabria, Italy(cont)

• Dr. Zoccali: A trial based on lung water measurement by US has been funded by the European Renal Association (ERA-EDTA). This trial, which will start very soon, will test the hypothesis that dialysis intensification in patients with subclinical pulmonary edema reduces mortality and the risk of heart failure and cardiovascular events.

• Hemodialysis.com: List the main limitations of the study.• Dr. Zoccali: Even though the study was multicenter and fairly large, our cohort was gathered in a limited geographical area in

Southern Italy.• Average mortality of dialysis patients in this area is very close to the average figure in European countries.• Furthermore patients of Caucasian descent composed our population only. Therefore, the prognostic ability of lung US

should be confirmed in other dialysis populations including a larger share of other ethnicities.• Finally, the usefulness of lung US remains to be tested in a formal clinical trial. The ERA-EDTA has now funded a clinical trial

testing whether a US-B Lines-guided clinical policy may improve clinical outcomes in high risk CKD-5D patients with cardiac disease.

• Hemodialysis.com: Please list all relevant financial disclosures and acknowledgements for corresponding author and co-authors. If no disclosures are included below, the following statement will appear on the press release: “The author(s) reported no financial disclosures.”

• Dr. Zoccali: No financial disclosures• Citation:• Pulmonary Congestion Predicts Cardiac Events and Mortality in ESRD• Zoccali C, Torino C, Tripepi R, Tripepi G, D’Arrigo G, Postorino M, Gargani L, Sicari R, Picano E, Mallamaci F;

on behalf of the Lung US in CKD Working Group.• *National Research Council-Institute of Biomedicine, Clinical Epidemiology and Physiopathology of Renal Diseases and

Hypertension, Reggio Calabria, Italy; and.J Am Soc Nephrol. 2013 Feb 28. [Epub ahead of print]

For Informational Purposes Only. Not for Specific Medical Advice

Page 11: Hemodialysis Nephrology Interviews March 9 2013

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Cost Analysis of Hemodialysis and Peritoneal Dialysis Access Costs in Incident Dialysis PatientsHemodialysis.com: Dr.Luis CoentrãoNephrology Research and Development UnitFaculty of Medicine, University of Porto & São João Hospital Centre

Alameda Professor Hernani Monteiro, Porto, 4202-451, Portugal

• Hemodialysis.com: What are the main findings of the study?• Dr. Coentrão: Both peritoneal catheters and arteriovenous fistulae are safe and effective dialysis accesses for

incident dialysis patients.

• Hemodialysis.com: Were any of the findings unexpected?• Dr. Coentrão: Peritoneal dialysis patients had fewer dialysis access-related invasive procedures in comparison with

hemodialysis patients with central venous catheters and fistulae.•

Hemodialysis.com: What should clinicians and patients take away from your report?• Dr. Coentrão: The peritoneal catheter should not be a barrier to the implementation

of a successfull peritoneal dialysis program.• Hemodialysis.com: What recommendations do you have for future research as a result of this study?• Dr. Coentrão:• Prospective evaluation of dialysis access patency and complications in the long term.• Prospective evaluation of peritoneal and central venous catheters placed in CKD patients with unplanned dialysis

start.• Citation:• Cost Analysis of Hemodialysis and Peritoneal Dialysis Access Costs in Incident Dialysis Patients• Luis A. Coentrao, Carla S. Araújo, Carlos A. Ribeiro, Claudia C. Dias, and Manuel J. Pestana• Perit Dial Int pdi.2011.00309;

published ahead of print March 1, 2013, doi:10.3747/pdi.2011.00309

For Informational Purposes Only. Not for Specific Medical Advice

Page 12: Hemodialysis Nephrology Interviews March 9 2013

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Impact of race on cumulative exposure to antihypertensive medications in dialysisHemodialysis.com Author Interview: Theresa I. Shireman, PhD, RPhProfessor and Director, MS-CR and TL1 Training Program

Department of Preventive Medicine & Public HealthDepartment of Health Policy & ManagementUniversity of Kansas School of Medicine

• Hemodialysis.com: What are the main findings of the study?

• Dr. Shireman: We found differential exposure over time to three classes of antihypertensives (ACE inhibitors/ARBs, beta-blockers, and calcium channel blockers) among chronic dialysis patients. Their exposure varied according to race/ethnicity, with African-Americans and Hispanics having lower levels of exposure over time as compared to Caucasians.

• Hemodialysis.com: Were any of the findings unexpected?

• Dr. Shireman: These findings were indeed unexpected. In our previous work, we demonstrated that persons on chronic dialysis who were minorities were more likely to receive each of these classes of medications (study citation #35 in the paper) in the first place. So, what the present study says is that once they are on the medication, they are less likely to stay on it over time, even though they had prescription drug coverage.

For Informational Purposes Only. Not for Specific Medical Advice

Page 13: Hemodialysis Nephrology Interviews March 9 2013

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Impact of race on cumulative exposure to antihypertensive medications in dialysisHemodialysis.com Author Interview: Theresa I. Shireman, PhD, RPhProfessor and Director, MS-CR and TL1 Training Program

Department of Preventive Medicine & Public HealthDepartment of Health Policy & ManagementUniversity of Kansas School of Medicine(cont)

• Other research has demonstrated that minorities are less likely to have their blood pressure controlled. Our study suggests that African-Americans and Hispanics are using prescribed medications at a lower rate than Caucasians. We cannot determine from these data whether it is an adherence issue or whether there is differential prescribing. Regardless, clinicians should be diligent about addressing barriers to medication access among their minority patients. Although this race disparity has been known in other contexts, this is the first time it has been described in a population of chronic dialysis patients.

• Hemodialysis.com: What recommendations do you have for future research as a result of this study?

• Dr. Shireman: Further research should attempt to distinguish if indeed this disparity is driven by patient or prescriber behavior. And of course, the implications for health outcomes, e.g., does this disparity translate into poorer outcomes for minority patients, should be examined.

• Citation:• Impact of race on cumulative exposure to antihypertensive medications in dialysis.• Wetmore JB, Mahnken JD, Rigler SK, Ellerbeck EF, Mukhopadhyay P, Hou Q, Shireman TI.• Department of Medicine, Division of Nephrology and Hypertension

University of Kansas School of Medicine, Kansas City, KS;Am J Hypertens. 2013 Feb;26(2):234-42. doi: 10.1093/ajh/hps019.Epub 2012 Dec 28

For Informational Purposes Only. Not for Specific Medical Advice

Page 14: Hemodialysis Nephrology Interviews March 9 2013

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Lethal cardiac arrhythmia during central venous catheterization in a uremic patientHemodialysis.com Interview with Jer-Ming Chang. MD. PhDSecretary for the Superintendant, and Attending physician, Department of Internal Medicine

Kaohsiung Municipal Hsiao-Kang HospitalAssociate professor, College of Medicine, Kaohsiung Medical UniversityKaohsiung 807, Taiwan

• Hemodialysis.com: What are the main findings of the study?• Dr. Chang: Cardiac arrhythmia induced during the procedure of central vein catheterization might be

more common than expected, especially in high-risk CKD patients (pre-existing CV diseases, electrolytes disturbances…).Continuous monitoring during procedure is recommended for safety.

• Hemodialysis.com: Were any of the findings unexpected?• Dr. Chang: Most of these unexpected arrhythmic events can be salvaged properly, unless unnoticed.• Hemodialysis.com: What should clinicians and patients take away from your report?• Dr. Chang: Before catheterization for CKD patients, clinicians are suggested to access the risk of

arrhythmia and patients are equally responsible for revealing detailed information in this respect.• Hemodialysis.com: What recommendations do you have for future research as a result of this study?• Dr. Chang: Unfortunately this is an undisputable safety issue and may not be suitable for study.• Citation:• Lethal cardiac arrhythmia during central venous catheterization in a uremic patient: A case report and

review of the literature• Huang, Y.-C., Huang, J.-C., Chen, S.-C., Chang, J.-M. and Chen, H.-C. (2013), Hemodialysis International.

doi: 10.1111/hdi.12030

For Informational Purposes Only. Not for Specific Medical Advice

Page 15: Hemodialysis Nephrology Interviews March 9 2013

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Feasibility of catheter-based renal nerve ablation and effects on sympathetic nerve activity and blood pressure in patients with ESRD

Hemodialysis.com Interview with: Professor Markus SchlaichMD, Nephrologist & Hypertension Specialist Adjunct Professor, Central Clinical SchoolFaculty of Medicine, Nursing & Health Sciences, Monash University NHMRC

Senior Research FellowHead, Neurovascular Hypertension & Kidney DiseaseBaker IDI Heart and Diabetes Institute 75 Commercial Road, Melbourne VIC 3004

• Hemodialysis.com: What are the main findings of the study?

• Professor Schlaich: This was a small proof-of concept and feasibility study to explore the usefulness of renal denervation in patients with ESRD on maintenance haemodialysis and uncontrolled blood pressure despite the use of an average of 3.8+/-1.4 antihypertensive drugs.

• The subset of patients who had assessment of sympathetic nerve activity displayed substantially elevated sympathetic tone. Renal denervation could be performed in 9 out of 12 patients. Three patients had renal artery diameters there were deemed too small to be treated. Compared to baseline, office systolic BP was significantly reduced at 3, 6, and 12 months after RDN (from 166±16.0 to 148±11, 150±14, and138±17mmHg, respectively), whereas no change was evident in the 3 non-treated patients. Sympathetic nerve activity was substantially reduced in 2 patients who underwent repeat assessment.

Hemodialysis.com: Were any of the findings unexpected?

Professor Schlaich: Diameter of the renal arteries in some of the patients were too small to be treated with the renal denervation catheter system available at the time. This may be a common problem, which potentially can be overcome by further technical developments and specifically designed catheters.

For Informational Purposes Only. Not for Specific Medical Advice

Page 16: Hemodialysis Nephrology Interviews March 9 2013

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Feasibility of catheter-based renal nerve ablation and effects on sympathetic nerve activity and blood pressure in patients with ESRD

Hemodialysis.com Interview with: Professor Markus SchlaichMD, Nephrologist & Hypertension Specialist Adjunct Professor, Central Clinical School

Faculty of Medicine, Nursing & Health Sciences, Monash University NHMRC Senior Research FellowHead, Neurovascular Hypertension & Kidney Disease

Baker IDI Heart and Diabetes Institute 75 Commercial Road, Melbourne VIC 3004(cont)

• Hemodialysis.com: What should clinicians and patients take away from your report?• Professor Schlaich: This is an initial and encouraging proof of concept study to demonstrate that renal denervation

can be applied safely and reduces both blood pressure and sympathetic nerve activity in patients with ESRD.• These initial results are uncontrolled and obtained in a small series of patients and therefore require confirmation in

larger and adequately controlled clinical trials. At this stage, renal denervation should only be considered in ESRD patients with uncontrolled blood pressure who have failed all other measures of lowering blood pressure. The procedure should only be performed in experienced centres. Renal artery imaging with exact assessment of the renal artery diameter is warranted before considering the procedure.

• Hemodialysis.com: What recommendations do you have for future research as a result of this study?• Professor Schlaich: Ideally, an adequately sized randomized controlled clinical trial should be performed to assess the

safety, efficacy, and long term consequences of catheter-based renal denervation in patients with ESRD.

• Citation:• Feasibility of catheter-based renal nerve ablation and effects on sympathetic nerve activity and blood pressure in

patients with end-stage renal disease.• Schlaich MP, Bart B, Hering D, Walton A, Marusic P, Mahfoud F, Böhm M, Lambert EA, Krum H, Sobotka PA, Schmieder

RE, Ika-Sari C, Eikelis N, Straznicky N, Lambert GW, Esler MD.• Int J Cardiol. 2013 Feb 28. pii: S0167-5273(13)00278-7. doi: 10.1016/j.ijcard.2013.01.218. [Epub ahead of print]• Neurovascular Hypertension & Kidney Disease and Human Neurotransmitters Laboratories Baker IDI Heart &

Diabetes Institute, Alfred Hospital, Melbourne, Australia; Heart Centre, Alfred Hospital, Melbourne, Australia; Faculty of Medicine, Nursing and Health Sciences and Department of Physiology, Monash University, Melbourne, Victoria, Australia.

For Informational Purposes Only. Not for Specific Medical Advice

Page 17: Hemodialysis Nephrology Interviews March 9 2013

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Effect of donor age and cold storage time on outcome in recipients of kidneys donated after circulatory death in the UKHemodialysis.com Author Interview: Dr. Dominic Summers MBBChirDepartment of Surgery, School of Clinical Medicine

University of Cambridge, Cambridge, UK

• Hemodialysis.com: What are the main findings of the study?• Dr. Summers:• Firstly, we were able to confirm our (and others) previous work that showed that there

seems to be very little difference in survival and graft function of kidneys from donation after circulatory death (DCD) and kidneys from donation after brain death (DBD).

• Secondly, we were able to show that, while kidneys from older donors perform less well than kidneys from younger donors, there is no evidence that this is a particular problem for DCD donor kidneys.

• Finally, we showed that DCD donor kidneys are more susceptible to cold ischemic injury.Hemodialysis.com: Were any of the findings unexpected?

• Dr. Summers: There is a very widely held view, both in the UK and elsewhere, that DCD donor kidneys from older donors fare particularly poorly, and that we need to be much more selective with DCD donor kidneys than DBD donor kidneys.

• We showed that this was not the case. In addition, the fact that DCD donor kidneys are more susceptible to cold ischemic injury was thought likely, but had never been demonstrated before.

For Informational Purposes Only. Not for Specific Medical Advice

Page 18: Hemodialysis Nephrology Interviews March 9 2013

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Effect of donor age and cold storage time on outcome in recipients of kidneys donated after circulatory death in the UKHemodialysis.com Author Interview: Dr. Dominic Summers MBBChirDepartment of Surgery, School of Clinical Medicine

University of Cambridge, Cambridge, UK(cont)

• Hemodialysis.com: What should clinicians and patients take away from your report?• Dr. Summers: This study provides more evidence and reassurance that kidneys from controlled DCD donors are a

valuable source of kidneys. This reassurance should mean that fewer DCD kidneys and potential donors are discarded and so more kidney transplants should take place.

• In addition, this has emphasized the need to transplant DCD donor kidneys quickly – this has already altered the national allocation policy in the UK, which has now been designed to minimize cold ischemia.

• Hemodialysis.com: What recommendations do you have for future research as a result of this study?• Dr. Summers: There is very large regional variation in the use of DCD donors in the UK and internationally.• It is important to understand the reasons for this, in order to increase overall donation rates. Further work that is of

interest is how to improve our ability to distinguish between ‘good’ and ‘bad’ kidneys for transplantation, to enable clinicians to make better choices for patients. This may include viability testing on ex-vivo rigs, better mathematical models, and the use of pre-implantation biopsies.

• Citation:• Effect of donor age and cold storage time on outcome in recipients of kidneys donated after circulatory death in the

UK: a cohort study.• Summers DM, Johnson RJ, Hudson A, Collett D, Watson CJ, Bradley JA.• Department of Surgery, School of Clinical Medicine, University of Cambridge, Cambridge, UK; Cambridge National

Institute for Health Research Biomedical Research Centre, Cambridge, UK; National Health Service Blood and Transplant, Bristol, UKLancet. 2012 Dec 19. pii: S0140-6736(12)61685-7doi: 10.1016/S0140-6736(12)61685-7. Epub ahead of print

For Informational Purposes Only. Not for Specific Medical Advice

Page 19: Hemodialysis Nephrology Interviews March 9 2013

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A Self-Management Approach to Developing a Potassium Education ToolRachel Linzon, Josie Caruso-Ditta, Marla McKerracher, York Region Chronic Kidney Disease Program – Mackenzie Health, Richmond Hill, Ontario, Canada.

• The development of the Potassium Education Tool was a continuous quality improvement program initiative.• Objective:• To incorporate a self-management approach in developing a potassium education tool (PET) to improve patient’s ability to self-manage the potassium in their diet and improve serum

potassium levels.• Method:• In order to evaluate our original PET for potassium, 81 participants receiving hemodialysis responded to a pre-test survey of open and closed-ended questions. These questions

addressed ease of understanding, usefulness and readability.• The responses from the closed-ended questions provided limited insight. It was the participant’s comments that provided the direction for the creation of a new PET. Participants

requested that the information is:• Alphabetized• Less cluttered• Larger font size• More cultural food choices• Specific quantities listed• Increased variety in fruits and vegetables

• The results influenced the development of a comprehensive PET booklet, which was piloted with a subgroup. Although the majority of the feedback was positive there was still a request for a single-page handout that could be taken to the grocery store, posted on the refrigerator and provide simplified guidelines to those requiring a low potassium diet.

• Subsequently, this booklet was adapted into a double-sided PET that was evaluated by a post-test survey.The final PET was distributed to all patients in the York Region Chronic Kidney Disease program.

• Effects of the double-sided PET were measured by comparing all patients’ serum potassium levels for 3 months with historical control.• Hemodialysis.com: What are the main findings of the study?• After developing a patient-centered tool, the format was adapted to meet patient needs and incorporate adult learning principles. In the post-survey for the double-sided PET,

participants reported:• More choices and variety• Less crowded• Easier to read• Specific portions and quantities identified• Results of the pre-test and post-test PET surveys were compared.

Ease of understanding improved from 94% pre-survey to 99% post-survey.• When comparing patients’ serum potassium, the averaged three-month results indicated a 24% improvement (12.7% to 9.7%) in potassium for patients with a serum potassium level

greater than 5.5mmol/L versus historical control.

For Informational Purposes Only. Not for Specific Medical Advice

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A Self-Management Approach to Developing a Potassium Education ToolRachel Linzon, Josie Caruso-Ditta, Marla McKerracher, York Region Chronic Kidney Disease Program – Mackenzie Health, Richmond Hill, Ontario, Canada.

(cont)

• Hemodialysis.com: Were any of the findings unexpected?

• Response: There were no unexpected findings.• Participants reported an increased independence in making food choices. The revised potassium tool reinforced person-focused care and

enabled patients to self-manage the potassium in their diet. This was evident in improved serum potassium levels.• Patients enjoyed the self-management approach which included them in the process of creating education that impacts their daily lives.• Hemodialysis.com: What should clinicians and patients take away from this study?

• Response: Incorporating self-management approaches to creating patient education tools, empowers and encourages independence in patients requiring renal replacement therapy.

• As educators, Renal Dietitians should recognize a shifting trend in patient education from a traditional approach to a self-management approach.

• In the traditional approach, the Dietitian is the expert telling the patient what foods they can and cannot eat to control serum potassium levels. In the traditional approach, the overall goal is for the patient to comply to their low potassium diet in order to achieve a safe and normal serum potassium level. A typical PET depicts food columns specifying foods to choose or avoid. Often patients feel their diet lacks variety and are confused about portions.

• Whereas, a self-management approach to developing a PET would encourage patient feedback, establish a partnership with the Renal Dietitian which would empower them with the knowledge required to manage the potassium in their diet.

• Hemodialysis.com: What recommendations do you have for future research as a result of your study?

• Response: Renal Dietitians should invite patients into the process of developing education tools and pilot the education with those who will use it. The feedback obtained in this process should be used to guide the development of education tools which will impact day-to-day lives of our patients.

• Citation:

• This abstract was presented as a poster at the NKF Conference in Gaylord Washington in May 2012.

For Informational Purposes Only. Not for Specific Medical Advice

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The GFR and GFR decline cannot be accurately estimated in type 2 diabeticsHemodialysis.com Authors’ InterviewPiero Ruggenenti MD Piero Ruggenenti, Mario Negri Institute for Pharmacological Research, Centro Anna Maria Astori, Science and

Flavio Gaspari ChemD Clinical ResearchCenter for Rare Diseases ‘Aldo & Cele Daccò’, Esteban Porrini Nephrology Section and Research Unit, Hospital Universitario de Canarias,Giuseppe Remuzzi MD

Clinical ResearchCenter for Rare Diseases ‘Aldo & Cele Daccò’,

• Hemodialysis.com: What are the main findings of the study?

• Response: The main finding of our study was that in hypertensive type 2 diabetes, subjects with normo- or micro-albuminuria, estimation formulas fail to detect glomerular hyperfiltration and to reliably describe GFR changes over time.

• Baseline GFR was significantly underestimated by all formulas and a six-month GFR reduction was fully missed, in particular in hyperfiltering patients.

• Long-term GFR decline was also underestimated by all formulas in the whole study group, as well as in hyper-, normo- and hypofiltering patients considered separately.

• Five formulas even generated false positive slopes in hyperfiltring patients. These data extend to subjects with diabetes, in particular to those with glomerular hyperfiltration or normal GFR, previous evidence that estimation formulas substantially underestimate GFR decline over time in patients with non diabetic kidney disease and established renal insufficiency.

• Actually, no appreciable improvement has been observed in the performance and accuracy of serum creatinine-based estimation formulas over more than 50 years, since the Effersoe formula was first introduced in clinical use for GFR estimation.

• Hemodialysis.com: Were any of the findings unexpected?

• Response: Relatively small studies had already challenged the role of estimation formulas in particular in patients with normal or increased GFR. In 2009 the Chronic Kidney Disease Epidemiology (CKD-Epi) Collaboration equation was developed to specifically address this limitation, but also the performance of this novel equation was questioned, in particular in subjects with diabetes.

• Actually, the CKD-Epi equation was found to largely underestimate the GFR and to perform even worse than other formulas in this population.• Thus, preliminary evidence that formulas do not reliably estimate the GFR was already available. The robustness of the findings, however, was

limited by the relatively small sample size of considered studies. There was only one large study in type 1 diabetes that however could not assess the performance of formulas over time due to the cross-sectional design.

• Thus, our present findings were expected on the basis of the above preliminary data. We definitely confirmed that none of the 14 most commonly used formulas reliably estimates actual GFR and provided the fully novel message that none of them accurately describe GFR changes over time.

For Informational Purposes Only. Not for Specific Medical Advice

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The GFR and GFR decline cannot be accurately estimated in type 2 diabeticsHemodialysis.com Authors’ InterviewPiero Ruggenenti MD Piero Ruggenenti, Mario Negri Institute for Pharmacological Research, Centro Anna Maria Astori, Science and

Flavio Gaspari ChemD Clinical ResearchCenter for Rare Diseases ‘Aldo & Cele Daccò’, Esteban Porrini Nephrology Section and Research Unit, Hospital Universitario de Canarias,Giuseppe Remuzzi MD

Clinical ResearchCenter for Rare Diseases ‘Aldo & Cele Daccò’,(cont)

• Hemodialysis.com: What should clinicians and patients take away from your report?

• Response: The take home message of our study is that no serum creatinine-based estimation formula can be used for the identification of subjects at increased risk of accelerated renal function loss and for the monitoring of renal disease progression and response to treatment in this population.

• The possibility to directly measure the GFR by appropriate techniques should be taken into consideration whenever the required expertise and facilities are available. Hopefully, the increasing availability of accurate, easily accessible and relatively inexpensive commercial kits for the measurement of plasma and urine concentrations of iohexol and other exogenous biomarkers of glomerular filtration allows to predict that direct GFR measurement by appropriate techniques might progressively become part of every day practice, in clinics and research, as already happened in recent years for the measurement of urinary albumin excretion.

• Unlike indirect estimates, direct GFR measurements will help identifying subjects at risk of progression even before the onset of nephropathy and independent of urinary albumin excretion.

• Hemodialysis.com: What recommendations do you have for future research as a result of this study?

• Response: Future research should aim at implementing more performant formulas to accurately describe kidney function in subjects with diabetes and, conceivably, to guide drug dosing in this population.

• Whether cystatin-based equations may be a valuable option in this context is also matter of investigation.• In the meantime, serial GFR measurements are instrumental to design renal function trajectory and predict risk of progression to end stage renal

disease and the effect of treatment in clinics and research.

• Citation:• The GFR and GFR decline cannot be accurately estimated in type 2 diabetics.• Kidney Int. 2013 Feb 27. doi: 10.1038/ki.2013.47. [Epub ahead of print]• Gaspari F, Ruggenenti P, Porrini E, Motterlini N, Cannata A, Carrara F, Jiménez Sosa A, Cella C,

Ferrari S, Stucchi N, Parvanova A, Iliev I, Trevisan R, Bossi A, Zaletel J, Remuzzi G.• Clinical ResearchCenter for Rare Diseases ‘Aldo & Cele Daccò’,

Mario Negri Institute for Pharmacological Research, Bergamo, Italy.

For Informational Purposes Only. Not for Specific Medical Advice

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Aldosterone and Mortality in Hemodialysis Patients: Role of Volume OverloadHemodialysis.com Author Interview: Dr. Der-Cherng Tarng, MD, PhD

Professor, Division of Nephrology, Department of Medicine, Taipei Veterans General Hospital, and Department and Institute of Physiology, National Yang-Ming University, Taipei, Taiwan

• Hemodialysis.com: What are the main findings of the study?

• Dr. Der-Cherng Tarng: Aldosterone level is inversely associated with adverse outcomes in hemodialysis patients. Volume overload underlies this paradox. In the absence of volume overload, aldosterone is an independent risk factor for all-cause mortality and CV events in this population.

• Hemodialysis.com: Were any of the findings unexpected?

• Dr. Der-Cherng Tarng: This study demonstrates an inverse association of aldosterone levels with all-cause mortality and CV event rates in the presence of volume overload. This represents a paradoxical effect of volume status on mortality. In contrast, there was a significant, graded, and positive association of aldosterone levels with all-cause mortality and CV event rates in the 64% of participants without volume overload.

For Informational Purposes Only. Not for Specific Medical Advice

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Aldosterone and Mortality in Hemodialysis Patients: Role of Volume OverloadHemodialysis.com Author Interview: Dr. Der-Cherng Tarng, MD, PhD

Professor, Division of Nephrology, Department of Medicine, Taipei Veterans General Hospital, and Department and Institute of Physiology, National Yang-Ming University, Taipei, Taiwan

(cont)

• Hemodialysis.com: What should clinicians and patients take away from your report?

• Dr. Der-Cherng Tarng: Some ESRD patients with low aldosterone levels have a low risk of adverse outcomes, as in the general population, whereas others have a high risk because they are in a state of volume overload, which lowers aldosterone levels and increases the risk of mortality and CV events.

• Hemodialysis.com: What recommendations do you have for future research as a result of this study?

• Dr. Der-Cherng Tarng: Our findings underline the importance of hyperaldosteronemia as a risk factor for adverse long-term outcomes among patients with ESRD, and of the masking of this association among individuals with volume overload.These findings support treatment of hyperaldosteronemia in hemodialysis patients who have achieved strict volume control.

• Hence, further research is warranted to clarify whether therapeutic interventions to mitigate volume overload and lower aldosterone concentrations may lead to improved outcomes in dialysis patients.

• Citation:Aldosterone and Mortality in Hemodialysis Patients: Role of Volume Overload.Hung S-C, Lin Y-P, Huang H-L, Pu H-F, Tarng D-C (2013)PLoS ONE 8(2): e57511. doi:10.1371/journal.pone.00

For Informational Purposes Only. Not for Specific Medical Advice

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CMV seropositivity is associated with increased arterial stiffness in patients with CKDHemodialysis.com Author Interview: Charlie J. Ferro, BSc, MD, FRCPSchool of Immunity and Infection, University of BirminghamBirmingham, United Kingdom

• Hemodialysis.com :What are the main findings of the study?• Dr. Ferro: Patients with chronic kidney disease have an increased cardiovascular

risk that is not fully explained by traditional risk factors but appears to be related to increased arterial stiffness. Cytomegalovirus (CMV) infection is associated with increased cardiovascular risk although the mechanisms for this are unknown. In our study, arterial stiffness, as measured by carotid-femoral pulse wave velocity and arterial aortic distensibilty, was consistently and considerably higher in CMV seropositive patients.

• Hemodialysis.com: Were any of the findings unexpected?• Dr. Ferro: Although our hypothesis was correct, we were surprised by the

robustness and magnitude of the effect. For example, CMV seropositivity was associated with an average increase in pulse wave velocity of 0.7 m/s across quartiles of age. This figure has been an associated with a considerable increase in cardiovascular risk.

For Informational Purposes Only. Not for Specific Medical Advice

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CMV seropositivity is associated with increased arterial stiffness in patients with CKDHemodialysis.com Author Interview: Charlie J. Ferro, BSc, MD, FRCPSchool of Immunity and Infection, University of BirminghamBirmingham, United Kingdom(cont)

• Hemodialysis.com: What should clinicians and patients take away from your report?

• Dr. Ferro: Our results highlight the fact that previous CMV infection may not be as trivial as is currently considered in non-heavily immunosuppressed individuals with chronic kidney disease.

• Hemodialysis.com: What recommendations do you have for future research as a result of this study?

• Dr. Ferro: These findings have significant potential implications for the mechanism by which CMV infection might influence cardiovascular disease. How CMV affects the structure and/or function of large arteries requires further investigation.

• Ultimately, reducing the prevalence of CMV seropositivity might be a potential way of reducing the burden of cardiovascular disease in patients with chronic kidney disease, or indeed in the general population.

• Citation:Cytomegalovirus seropositivity is associated with increased arterial stiffness in patients with chronic kidney disease.

• Wall NA, Chue CD, Edwards NC, Pankhurst T, Harper L, Steeds RP, Lauder S, Townend JN, Moss P, Ferro CJ.School of Immunity and Infection, University of Birmingham, Birmingham, United Kingdom ; Department of Nephrology, Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom.

• PLoS One. 2013;8(2):e55686. doi: 10.1371/journal.pone.0055686.• Epub 2013 Feb 25.

For Informational Purposes Only. Not for Specific Medical Advice

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High-Efficiency Postdilution On-Line Hemodiafiltration Reduces All-Cause Mortality in Hemodialysis PatientsHemodialysis.com Author Interview:Dr. Francisco MaduellDepartment of Nephrology and Renal Transplantation

Hospital Clinic, University of BarcelonaVillarroel, 170 – 08036 Barcelona, Spain.

• Hemodialysis.com: What are the main findings of the study?

• Dr. Maduell: The results of the ESHOL trial indicate that high efficiency postdilution OL-HDF reduces all-cause mortality versus conventional hemodialysis in prevalent patients.

• Furthermore, the main causes of mortality, cardiovascular and infectious diseases, were significantly reduced by OL-HDF. The incidence rate of dialysis sessions complicated with hypotension episodes and all-cause hospitalization were lower in patients randomized to OL-HDF

• Hemodialysis.com: Were any of the findings unexpected?• Dr. Maduell: Findings in stroke were unexpected and no previously described.

Stroke mortality was significantly lower in the OL-HDF group than in the hemodialysis group. The Cox proportional hazards model showed that OL-HDF caused a significant 61% risk reduction in mortality from stroke.

For Informational Purposes Only. Not for Specific Medical Advice

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High-Efficiency Postdilution On-Line Hemodiafiltration Reduces All-Cause Mortality in Hemodialysis PatientsHemodialysis.com Author Interview:Dr. Francisco MaduellDepartment of Nephrology and Renal Transplantation

Hospital Clinic, University of BarcelonaVillarroel, 170 – 08036 Barcelona, Spain. (cont)

• Hemodialysis.com: What should clinicians and patients take away from your report?• Dr. Maduell: In view of these results, OL-HDF may become the first-line option in hemodialysis patients.

• Hemodialysis.com: What recommendations do you have for future research as a result of this study?

• Dr. Maduell: The convective volume seems to be an important issue. ESHOL study showed a 40% and 45% mortality risk reduction in patients receiving convection volumes between 23 to 25 L/ session and higher than 25 L/session, respectively. To achieve this goal, high blood flow rates and long dialysis times are required.

• Therefore, in future studies, the convective volume dose should be defined as a minimum postdilution volume, a minimum infusion flux, a convective volume normalized to body-size, or other factors.

• Citation:• High-Efficiency Postdilution On-Line Hemodiafiltration Reduces All-Cause Mortality in Hemodialysis

Patients• Maduell F, Moreso F, Pons M, Ramos R, Mora-Macià J, Carreras J, Soler J, Torres F, Campistol JM,

Martinez-Castelao A; for the ESHOL Study Group.• *Nephrology Department, Hospital Clinic, Barcelona, Spain;

J Am Soc Nephrol. 2013 Feb 14. [Epub ahead of print]

For Informational Purposes Only. Not for Specific Medical Advice

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Periodontitis and chronic kidney disease: a systematic review of the association of diseases and the effect of periodontal treatment on eGFRHemodialysis.com Author Interview: Leandro Chambrone – DDS, MSc, PhD

Professor and Vice International Advisor, Dental Research Division, Department of Periodontics,Division of Periodontics, School of Dentistry, University of São Paulo

Cochrane Oral Health Group Member – The Cochrane Collaboration – UK

• Hemodialysis.com Author Interview: Leandro Chambrone – DDS, MSc, PhDSpecialist in PeriodontologySpecialist in Orthodontics & Dentofacial OrthopedicsProfessor and Vice International Advisor, Dental Research Division, Department of Periodontics,Guarulhos University research fellowDivision of Periodontics, School of Dentistry, University of São PauloCochrane Oral Health Group Member – The Cochrane Collaboration – UK

• Hemodialysis.com: What are the main findings of the study?

LC – The outcomes of this systematic review on the association between periodontitis and chronic kidney disease (CKD) and the effect of periodontal treatment on the estimated glomerular filtration rate showed that the majority of included observational studies (80.0%) showed some association between periodontitis and CKD; Also, pooled estimates sustained this assumption argument.

• Studies’ individual outcomes showed that estimated glomerular filtration rate can be improved by periodontal treatment (but this argument could not confirmed by pooled estimates due to the reduced number of studies available for analysis and to differences between individual studies’ methodologies). Overall, and despite of these issues, there is quite secure evidence to support the positive association between periodontitis and CKD. However, definitive conclusions regarding the positive effects of periodontal treatment cannot be effectively reached at this moment in time.

• Hemodialysis.com: Were any of the findings unexpected?LC – Not at all since different sources of evidence suggest that the inflammatory response triggered by periodontitis can also modify the host response in other parts of the body, by negatively affecting glycemic control and increasing the risk of stroke and pre-term birth. Consequently, it could be argued that periodontitis might also interact with different forms of chronic kidney disease.

For Informational Purposes Only. Not for Specific Medical Advice

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Periodontitis and chronic kidney disease: a systematic review of the association of diseases and the effect of periodontal treatment on eGFRHemodialysis.com Author Interview: Leandro Chambrone – DDS, MSc, PhD

Professor and Vice International Advisor, Dental Research Division, Department of Periodontics,Division of Periodontics, School of Dentistry, University of São Paulo

Cochrane Oral Health Group Member – The Cochrane Collaboration – UK (cont)

• Hemodialysis.com: What should clinicians and patients take away from your report?

LC – ‘Clinicians and patients should take in mind that such an association seems biologically plausible.• Periodontitis might be considered a non-traditional risk for chronic kidney disease CKD because of the source of ‘permanent’

systemic inflammation burden caused by periodontal inflammation (and its locally produced inflammatory mediators), as well as due to the presence of bacteria and their products in the bloodstream that could lead to kidney endothelium damage Overall, Subjects with periodontitis should be instructed about the importance of periodontal health.

• Also, clinicians could be advised to refer their patients for a periodontal examination (as a routine for subjects with chronic kidney disease).

• Hemodialysis.com: What recommendations do you have for future research as a result of this study?• LC – ‘Cross-sectional, case-control and prospective cohort studies allocating patients into subgroups according to the

extension, severity and type of periodontitis will allow more accurate evaluations. Also, there is an urgent need for randomized clinical trials reporting future interventional studies (i.e. the effect of successful periodontal treatment on kidney diseases).

• Citation:• Periodontitis and chronic kidney disease: a systematic review of the association of diseases and the effect of periodontal

treatment on estimated glomerular filtration rate.• Chambrone L, Foz AM, Guglielmetti MR, Pannuti CM, Artese HP, Feres M, Romito GA.

Department of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, SP, Brazil; Department of Stomatology, Division of Periodontics, School of Dentistry, University of São Paulo, São Paulo, SP, Brazil.J Clin Periodontol. 2013 Jan 15. doi: 10.1111/jcpe.12067. [Epub ahead of print]

For Informational Purposes Only. Not for Specific Medical Advice

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The quality of cardiovascular disease care for adolescents with kidney diseaseHemodialysis.com Author Interview: Uptal D. Patel, MD

Associate Professor of Medicine and Pediatrics Divisions of Nephrology and Pediatric NephrologyDuke University School of MedicineDuke Clinical Research Institute Durham, NC 27705

• Hemodialysis.com : What are the main findings of the study?• Cardiovascular disease is the leading cause of death for young adults who had kidney

disease as children, and several recommendations for the assessment and treatment of cardiovascular risk factors in adolescents with kidney disease have been promulgated over the past decade.Yet, very little is known about current practice patterns.

• Our study demonstrated that adolescent patients with kidney disease are receiving variable and suboptimal preventative cardiovascular care – cardiovascular disease risk factors were assessed or treated less than 60% of the time.

• Hemodialysis.com : Were any of the findings unexpected?` • Transition programs are promoted as a means to improve care for adolescents

transferring to adult nephrologists, yet there are few studies evaluating this claim. We found that going through a formal transition program was independently associated with a 21 % increase in cardiovascular risk assessments, suggesting a potential mechanism through which to improve cardiovascular care for adolescents with kidney disease.

For Informational Purposes Only. Not for Specific Medical Advice

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The quality of cardiovascular disease care for adolescents with kidney diseaseHemodialysis.com Author Interview: Uptal D. Patel, MDAssociate Professor of Medicine and Pediatrics Divisions of Nephrology and Pediatric Nephrology

Duke University School of MedicineDuke Clinical Research Institute Durham, NC 27705 (cont)

• Hemodialysis.com : What should clinicians and patients take away from your report?• We believe that these findings expose an important barrier to improving cardiovascular outcomes for these

high-risk patients. There is tremendous opportunity to lower the high cardiovascular disease burden and improve long-term cardiovascular by improving the reliability of preventive care.

• In addition, formal transition programs may provide a potential mechanism to deliver more reliable cardiovascular care.

• Hemodialysis.com : What recommendations do you have for future research as a result of this study?• Our analyses were based on retrospective chart reviews and subject to a number of potential biases.

Prospective studies may provide greater insights into current clinical practice and the potential impact of transition programs.

• Citation:• The quality of cardiovascular disease care for adolescents with kidney disease: a Midwest Pediatric

Nephrology Consortium study.• Hooper DK, Williams JC, Carle AC, Amaral S, Chand DH, Ferris ME, Patel HP, Licht C,

Barletta GM, Zitterman V, Mitsnefes M, Patel UD.• Division of Nephrology & Hypertension,

Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA.Pediatr Nephrol. 2013 Feb 17. [Epub ahead of print]

For Informational Purposes Only. Not for Specific Medical Advice

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Handoff communication between hospital and outpatient dialysis units at patient dischargeHemodialysis.com Author Interview: James B. Reilly, MD, MSHP, FACP

Assistant Professor of Clinical Medicine University of Pennsylvania – Department of MedicineDirector of Residency Training – Penn Presbyterian Medical CenterAssociate Director, Penn Internal Medicine Residency

Philadelphia, PA 19104

• Hemodialysis.com: What are the main findings of the study?

• Dr. Reilly: Hemodialysis patients are vulnerable patients who have highly complex medical care plans that require a high degree of interprofessional coordination. We know that these patients are also at risk for hospitalizations and patient safety events, including readmissions to the hospital that might be prevented with improved communication between the hospital and the outpatient dialysis center. We interviewed physicians, nurses and social workers on both inpatient and outpatient dialysis teams in hopes of understanding the nature of this communication.

• We found that the quality of this communication, and the ways it is conducted, is extremely variable, due to the fast pace and complexity of the hospital in today’s health care environment, as well as the complex needs of the dialysis population. It can be very difficult to perform this communication well, but while our participants stated that generally the quality must improve, most of our participants could agree on what information was important to transmit. Our participants also agreed that poor or absent communication can result in adverse events, including readmissions or death. Our participants stated that to improve the process of communication between the hospital team and dialysis clinics, and to improve the quality of care during this vulnerable transition, the handoff process must become standard work with a clear role for each member of the team, to ensure accountability and promote continuous improvement.

• Hemodialysis.com: Were any of the findings unexpected?

• Dr. Reilly: Yes, we were surprised by a few things. First, we were surprised that suggestions for improvement and descriptions of the “perfect world” process seemed superficial and vague, in response to very specific concerns raised in earlier parts of the interview. Given how passionate many of these folks were during their interviews we didn’t interpret this as a lack of initiative or interest on the part of our participants but, instead, it’s further evidence that no one person can design this process to run well – it needs to be team-driven work.

• Second, we were surprised to hear how patients’ perceptions of poor communication seems to erode their trust. We did not have the opportunity to interview patients in this study but would love to explore that theme further in the future.

• Finally, though not surprising, we feel like we developed a novel model for dialysis-specific communication, unique from previous handoff models in that it must combine tenets of comprehensive hospital discharge initiatives (such as the Guided Care model) with the timeliness and two-way nature of an intra-hospital unit-to-unit handoff.

For Informational Purposes Only. Not for Specific Medical Advice

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Handoff communication between hospital and outpatient dialysis units at patient dischargeHemodialysis.com Author Interview: James B. Reilly, MD, MSHP, FACP

Assistant Professor of Clinical Medicine University of Pennsylvania – Department of MedicineDirector of Residency Training – Penn Presbyterian Medical CenterAssociate Director, Penn Internal Medicine Residency

Philadelphia, PA 19104(cont)

• Hemodialysis.com: What should clinicians and patients take away from your report?• Dr. Reilly: We want clinicians to focus on the fact that this is a highly complex process, with no quick fix (particularly when it comes to solutions

grounded in Infomation Technology).• What’s most important for a physician to understand is that it takes every member of the interprofessional team to create the process, and it’s likely

to be institution-specific: what works for one team, or one hospital, may not work for another.• Further, we hope that hospital leadership will recognize dialysis patients as the perfect population to study when it comes to this type of

communication. Dialysis patients’ needs for complex, highly coordinated interprofessional care make these handoffs a very sensitive barometer with which to gauge the overall quality of handoffs within an organization.

• We hope that patients reading this article will hopefully gain an understanding that their dialysis treatments are very complex and often have to be changed in response to acute illnesses that land them in the hospital. As a result, their normal outpatient dialysis plan might no longer be appropriate when they return from a hospitalization, or additional medications (like antibiotics) might need to be given during treatment for a time.

• Patients and their families should not assume that “one size fits all” when it comes to the treatment itself, and should know as much as possible about their dialysis.

• Dialysis clinics will have to rely on them to serve as a much-needed safety check by asking hospital teams “have there been any changes to my dialysis?” when they are discharged, and being sure to notify their clinics before their first outpatient treatment if that answer is “yes” for any reason. It could save their life.

• Hemodialysis.com: What recommendations do you have for future research as a result of this study?• Dr. Reilly: At our hospital we have formed a robust interprofessional working group to address this and other issues. A multidisciplinary discharge

handoff process has been put in place as a first step to standardizing an intervention that could be tested on a larger scale. A multi-center cluster trial would hopefully show better outcomes for hospitalized patients once such interventions are refined and tested on a smaller scale. Importantly, the patient’s role in this communication is another opportunity for study in this field.

• Citation:• Handoff communication between hospital and outpatient dialysis units at patient discharge: a qualitative study.• Reilly JB, Marcotte LM, Berns JS, Shea JA.• Renal-Electrolyte and Hypertension Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA.

Jt Comm J Qual Patient Saf. 2013 Feb;39(2):70-6.

For Informational Purposes Only. Not for Specific Medical Advice

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Type of PKD1 Mutation Influences Renal Outcome in ADPKDHemodialysis.com Author Interview:Dr. Claude FérecINSERM U1078 and EFS-BretagneBrest, France

• Hemodialysis.com: What are the main findings of your study?• Prof. Ferec: Our main result is the first description of the influence of mutation type on renal survival.• We have shown that PKD1 truncating mutations are associated with a median age at ESRD of 55.4 years,

whereas there is a 12 years delay in ESRD onset for non-truncating mutations.

• We assessed robustness of our findings in a multivariate cox model entering age and gender, people with truncating mutation are 2.74 times more likely to develop ESRD than people with non truncating mutations.

• This new knowledge can be integrated in a single scheme with gene influence, and we can now describe 3 groups of predicted severity according to genotype.

• PKD1 truncating mutations are associated with the more severe phenotype, PKD1 non-truncating mutations are of intermediate severity and PKD2 mutations are still representing the milder group.

• We can assume therefore that molecular analysis in ADPKD may become a useful prognostic tool.

• Hemodialysis.com: Were any of the findings unexpected?• Prof. Ferec: The strong effect of the type of mutation on renal survival was not expected.• Hemodialysis.com: What should clinicians and patients take away from your report?• It is now really important to know if the patient and his family is carrying a PKD1 or a PKD2 gene

mutation and if the patient is bearing a truncating or a non-truncating mutation.

For Informational Purposes Only. Not for Specific Medical Advice

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Type of PKD1 Mutation Influences Renal Outcome in ADPKDHemodialysis.com Author Interview:Dr. Claude FérecINSERM U1078 and EFS-BretagneBrest, France(cont)

• Hemodialysis.com: What recommendations do you have for future research as a result of this study?

• Prof. Ferec: I would like to underline the importance to genotype ADPKD patients for the routine follow up of their disease as well the interest of knowing their mutation for their inclusion in the coming clinical trials.

• Citation:• Type of PKD1 Mutation Influences Renal Outcome in ADPKD• Emilie Cornec-Le Gall, Marie-Pierre Audrézet, Jian-Min Chen, Maryvonne

Hourmant, Marie-Pascale Morin, Régine Perrichot, Christophe Charasse, Bassem Whebe, Eric Renaudineau, Philippe Jousset, Marie-Paule Guillodo, Anne Grall-Jezequel, Philippe Saliou, Claude Férec, and Yannick Le Meur

• JASN ASN.2012070650; published ahead of print February 21, 2013, doi:10.1681/ASN.2012070650

For Informational Purposes Only. Not for Specific Medical Advice

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End-Stage Renal Disease in Nursing Homes: A Systematic ReviewHemodialysis.com Author Interview:Rasheeda K. Hall, MD, MBADuke University Medical CenterDurham, NC 27710.

• Hemodialysis.com: What are the main findings of the study?• Dr. Hall: We found 14 observational studies that included this population, and

the main findings demonstrate that nursing home residents with end-stage renal disease have limited survival and significant functional impairment, but information on prevalence, quality of life, dialysis-specific management, and other clinical outcomes in this population is limited.

Hemodialysis.com: Were any of the findings unexpected? • Dr. Hall: Yes, we did not expect to find that several of the studies in the review

focused on outcomes in peritoneal dialysis (PD) patients in nursing homes. These studies were conducted in the 1990s and demonstrated the feasibility of PD therapy in nursing homes through coordinated care with dialysis units. Still, there were conflicting findings in peritonitis and exit-site infection rates so additional research on PD-related outcomes in nursing home residents is still needed.

For Informational Purposes Only. Not for Specific Medical Advice

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End-Stage Renal Disease in Nursing Homes: A Systematic ReviewHemodialysis.com Author Interview:Rasheeda K. Hall, MD, MBADuke University Medical CenterDurham, NC 27710.(cont)

• Hemodialysis.com: What should clinicians and patients take away from your report?

• Dr. Hall: The population of end-stage renal disease patients that reside in nursing homes is vulnerable, and both dialysis providers and nursing homes should increase attention to the management of this population.

• Hemodialysis.com: What recommendations do you have for future research as a result of this study?

• Dr. Hall: Future research should focus on studying nursing home practices in management of dialysis patients.

• Citation:• End-Stage Renal Disease in Nursing Homes: A Systematic Review• Rasheeda K. Hall, Ann M. O’Hare, Ruth A. Anderson, Cathleen S. Colón-Emeric

JAMDA – 04 February 2013 (10.1016/j.jamda.2013.01.004)For Informational Purposes Only. Not for Specific Medical Advice

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The prevalence of potentially inappropriate medication prescribing in elderly patients with CKD Hemodialysis.com Author Interview: Prof Sunil BhandariConsultant Nephrologist/Honorary Clinical ProfessorDirector of Clinical Studies HYMS

Head of School of Medicine (East)Chair of MBBS Programme Board

• Hemodialysis.com: What are the main findings of the study?• Prof: Bhandari: The prevalence of potentially inappropriate

(contra-indicated, dosing error based on eGFR) medication prescribing in elderly patients (>70years) with chronic kidney disease stages 3-5 (mean eGFR 17ml/min/1.73m2) is high at 56%. The main drugs inappropriately prescribed are antibiotics (21%) and antihypertensive (19%).Hemodialysis.com: Were any of the findings unexpected?

• Prof: Bhandari: Not really. This study confirmed that there remains a gap in vigilance to drug prescribing and dose adjustment when considering renal impairment in elderly patients.

For Informational Purposes Only. Not for Specific Medical Advice

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The prevalence of potentially inappropriate medication prescribing in elderly patients with CKD Hemodialysis.com Author Interview: Prof Sunil BhandariConsultant Nephrologist/Honorary Clinical Professor

Director of Clinical Studies HYMSHead of School of Medicine (East)Chair of MBBS Programme Board (cont)

• Hemodialysis.com: What should clinicians and patients take away from your report?

• Prof: Bhandari: Routine calculation and perhaps documentation of the eGFR on the medication chart may be helpful to reduce inappropriate prescribing.

• Hemodialysis.com: What recommendations do you have for future research as a result of this study?• Prof: Bhandari: The

re is a lack of a unified formula which can be used both for calculation the stage of CKD and for prescribing in renal impairment. This is an area which perhaps deserves further study as there remains confusion around this issue.

• Also larger studies implementing an eGFR calculation to ascertain whether this simple intervention is effective or perhaps a study to examine a switch to electronic prescribing with an automated eGFR calculation and drug dose adjustment for clinicians.

• Citation:• The prevalence of potentially inappropriate medication prescribing in elderly patients with chronic kidney

disease.• Jones SA, Bhandari S.• York Teaching Hospital NHS Foundation Trust, York, UK.

Postgrad Med J. 2013 Feb 16. [Epub ahead of print]

For Informational Purposes Only. Not for Specific Medical Advice

Page 41: Hemodialysis Nephrology Interviews March 9 2013

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Associations between Hemodialysis Access Type and Clinical Outcomes: A Systematic ReviewHemodialysis.com Author Interview: Dr. Pietro Ravani,University of Calgary, Faculty of Medicine,

Foothills Medical Centre, 1403 29th Street NW, CalgaryAlberta, Canada T2N 2T9

• Hemodialysis.com: What are the main findings of the study?• Dr. Ravani: Most available data compare outcomes by access achieved/used rather than access

intended/planned.• Hemodialysis.com: Were any of the findings unexpected? • Dr. Ravani: Insufficient information exists to inform clinical decision making about optimal access

choice for a given patient.• Hemodialysis.com : What should clinicians and patients take away from your report?• Dr. Ravani: Fistula may not be superior to catheters in all patients.• Hemodialysis.com: What recommendations do you have for future research as a result of this study?• Dr. Ravani: Studies minimizing selection bias by comparing outcomes of intended access strategies (as

opposed to access achieved) are needed.• Citation:• Clinical Epidemiology: Associations between Hemodialysis Access Type and Clinical Outcomes: A

Systematic Review• Pietro Ravani, Suetonia C. Palmer, Matthew J. Oliver, Robert R. Quinn, Jennifer M. MacRae, Davina J.

Tai, Neesh I. Pannu, Chandra Thomas, Brenda R. Hemmelgarn, Jonathan C. Craig, Braden Manns, Marcello Tonelli, Giovanni F.M. Strippoli, and Matthew T. JamesJASN ASN.2012070643; published ahead of print February 21, 2013, doi:10.1681/ASN.2012070643

For Informational Purposes Only. Not for Specific Medical Advice

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Comparison Analysis of Nutritional Scores for Serial Monitoring of Nutritional Status in Hemodialysis Patients Hemodialysis.com: Author Interview: Dr Ilia Beberashvili MDNephrology DivisionAssaf Harofeh Medical Center, Zerifin 70300, Israel.

• Hemodialysis.com: What are the main findings of the study?• Dr. Beberashvili : In the current study we examined the longitudinal validity of the MIS

(malnutrition-inflammation score) and GNRI (geriatric nutritional risk index) to determine the impact of change in these scoring systems over time on the change in nutritional parameters burden in prevalent HD patients. Our findings suggest that in the clinical setting either MIS or GNRI are valid tools for longitudinal observation of nutritional status of prevalent HD patients and should be used for this purpose taking into account both, the type of the score (if it based on subjective or objective examination) and its inter-rater and intra-rater agreements. MIS was more comprehensive than GNRI because of better concurrent and predictive validity, but exhibited lower reproducibility than GNRI.

• Hemodialysis.com: Were any of the findings unexpected?

Dr. Beberashvili : In opposite to the results of prospective observational study exploring predictive validity of GNRI in a Japanese population, GNRI did not appear as a useful predictor of all cause mortality in our cohort during up to 5 years of observation. This discrepancy might have been caused by differences in the cohorts: dietary and body composition norms of Japanese people may be different from Caucasians. Further studies with larger number of observations are needed to identify a predictive validity of GNRI in Caucasian HD patients.

For Informational Purposes Only. Not for Specific Medical Advice

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Comparison Analysis of Nutritional Scores for Serial Monitoring of Nutritional Status in Hemodialysis PatientsHemodialysis.com: Author Interview: Dr Ilia Beberashvili MDNephrology Division

Assaf Harofeh Medical Center, Zerifin 70300, Israel. (cont)

• Dr. Beberashvili : MIS seems a good tool for nutritional screening and longitudinal observation of hemodialysis patients. It was reported early to correlate with morbidity, mortality, various nutritional variables, inflammation, quality of life, anemia and erythropoietin hyporesponsiveness in maintenance hemodialysis patients. One potential problem with MIS is its subjective nature that reduces its reproducibility, thus small differences in MIS must be interpreted with great caution.

• Hemodialysis.com: What recommendations do you have for nephrology health care providers as a result of your study?

Dr. Beberashvili : Taken into account lower reproducibility of MIS from one hand, and the high prevalence of global cognitive impairment in persons with end-stage renal disease from the other, objective score (such as GNRI) would be preferred in identifying of protein-energy malnutrition in hemodialysis patients. Indeed, GNRI had almost perfect intra- and inter-rater reliability in our study, but lower concurrent validity compared with MIS. Furthermore, predictive validity of GNRI must be examined in maintenance HD patients of all major race/ethnic groups.

• Citation:• Comparison Analysis of Nutritional Scores for Serial Monitoring of Nutritional Status in Hemodialysis Patients• Beberashvili I, Azar A, Sinuani I, Kadoshi H, Shapiro G, Feldman L, Averbukh Z, Weissgarten J.• Nephrology Division and, †Nutrition Department, Assaf Harofeh Medical Center, Sackler Faculty of Medicine,

Tel Aviv University, Zerifin, Israel.• Clin J Am Soc Nephrol. 2013 Feb 14.

[Epub ahead of print]

For Informational Purposes Only. Not for Specific Medical Advice

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Thrombophilia and Arteriovenous Fistula Survival in End Stage Renal DiseaseHemodialysis.com Author Interview: Dr. Riitta LassilaCoagulation Disorders UnitHematology and HUSLABHelsinki University Central HospitalHelsinki, Finland

• Hemodialysis.com: What are the main findings of the study?

• Dr. Lassila: Arteriovenous fistulas (AVF) reconstructed for using patient’s own vessels (even without prosthesis material) carry a high risk offailure upon waiting for maturation and for the use for dialysis.

• One-year AVF failure rate in Finnish patients treated at Helsinki University Central Hospital (n=219, during 2002-2004) was 32%. Almost half of the failures occurred already prior to fistula use. The high flow rate in fistulas creates conditions where platelets get activated and adhere to the fistula wall. Upon repetitive needle sticks subendothelial matrix is exposed to blood imitating thrombus formation. We were interested in assessing whether coagulation abnormalities (hypercoagulability: e.g. elevated FVIII: C, fibrinogen and D-dimer)) and thrombophilia (factor V Leiden, prothrombin mutation, deficiencies of natural anticoagulants protein C, protein S and antithrombin) were associated with AVF survival.

• Hypercoagulability was frequent: among 77% of the patients having end stage renal disease. Against this background female gender (2.6-fold risk) and the presence of thrombophilia (2.2-fold risk) indeed associated with impaired survival of the fistula.

• The functional failure (after taking AVF to use) associated also with thrombophilia mutations or low antithrombin (3.6-fold risk), female gender (2.5-fold risk) and diabetes (1.9-fold risk).

• Hemodialysis.com: Were any of the findings unexpected?• Dr. Lassila: The frequency of elevated FVIII and fibrinogen levels and of ongoing fibrin turnover (elevated D-dimer) was

surprising. This finding seems compatible with the thrombogenic profile in this patient population with a high risk of cardiovascular complications.

• As many of the patients had a cardiovascular history already, many of them also had antithrombotic medication. This may be one reason for the relatively good patency rate among our patients. However, we cannot analyze the role of antithrombotic therapy with our study design.

For Informational Purposes Only. Not for Specific Medical Advice

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Thrombophilia and Arteriovenous Fistula Survival in End Stage Renal DiseaseHemodialysis.com Author Interview: Dr. Riitta LassilaCoagulation Disorders UnitHematology and HUSLAB

Helsinki University Central Hospital Helsinki, Finland (cont)

• Hemodialysis.com: What should clinicians and patients take away from your report?• Dr. Lassila: If the patient has had prior history of thrombosis or cardiovascular complications or has a family history of

thrombosis and a previous AVF failure, screening of thrombophilia seems useful to pick up the high risk for (the repetitive) AVF failure.

• These patients could be anticoagulated to downplay the thrombophilia-associated coagulation activity caused if other clinical features support this decision.

• During and in-between dialysis sessions the heparin levels (mainly low- molecular weight heparin in our center) wax and wane causing unstable control of coagulation. It may be useful to tailor a more stable anticoagulation with e.g. low molecular weight heparin or use warfarin when clinically indicated. Acetylsalicylic acid and dipyridamole are of limited help in maintaining patency but when combined with heparin could turn out beneficial if bleeding risks are observed and excluded during follow-up (e.g. anemia (hematocrit < 30%), thrombocytopenia, lowered production of vitamin-K dependent coagulation factor in non-warfarin population).

• Dr. Lassila: What recommendations do you have for future research as a result of this study?• Dr. Lassila: The knowledge of high levels of FVIII, fibrinogen and D-dimer which associate with both the risks of arterial and

venous thrombosis could be used as surrogate markers in further studies to assess the role antithrombotic (including anticoagulants) remedies. Our aims should be to improve the fate of AVF without compromising safety.

• Patients who on top of these coagulation abnormalities carry thrombophilias carry the greatest thrombosis risks.• Citation:• Thrombophilia and Arteriovenous Fistula Survival in ESRD.• Salmela B, Hartman J, Peltonen S, Albäck A, Lassila R.• Coagulation Disorders, Department of Hematology,, †Department of Nephrology, Division of Internal Medicine;, ‡Department

of Vascular Surgery, and , §Department of Clinical Chemistry, HUSLAB Laboratory Services, Helsinki University Central Hospital, Helsinki, Finland.Clin J Am Soc Nephrol. 2013 Feb 14. [Epub ahead of print]

For Informational Purposes Only. Not for Specific Medical Advice