DIALYSIS TIMESNEWS & VIEWS FROM RRI

Morrell Michael Avram, M.D.and Paul A. Fein, M.D.

Division of NephrologyLong Island College HospitalBrooklyn, New York

IntroductionAccording to the

2001 United StatesRenal Data System(USRDS) Report, theprevalent hemodialysisand transplant popu-lation have seen thegreatest growth since1990, while the num-ber of patients onperitoneal dialysis hascontinued to fall since

its peak in 1996.(1) The decline in peritoneal dial-ysis population appears to coincide with publica-tion of studies showing adverse outcome onperitoneal dialysis compared to hemodialysis (HD).However, more recent studies have shown thatthe two therapies are more difficult to comparethan previously thought, and certain patient pop-ulations fare better on one modality than on theother.(2;3) In some parts of the world, peritonealdialysis is more popular than hemodialysis. Fifty-five percent of New Zealand patients are on peri-toneal dialysis compared to 9% in US and 4% in

Japan.(1) At present, 15% of the world populationis treated with peritoneal dialysis.There are severaladvantages of peritoneal dialysis over hemodialysis.ESRD patients should be educated as to the con-venience of peritoneal dialysis over hemodialysis.More attention should be paid to improve sur-vival and quality of life in peritoneal dialysispatients. At Long Island College Hospital, wehave had the largest number of peritoneal dialysispatients in New York. We have been involved inresearch to improve survival and quality of life inperitoneal dialysis patients. Our research is par-ticularly focused on lipid metabolism and nutri-tional status in peritoneal dialysis patients. Moreclinical and basic research for peritoneal dialysisis needed. We will briefly report some of ourwork in this field and follow with recommenda-tions to reverse the above-noted trend.

Lipid abnormalitiesCardiovascular disease is the most important

cause of mortality in peritoneal dialysispatients.(4) Peritoneal dialysis patients exhibitnumerous disturbances of serum lipids andlipoproteins that may contribute to their high car-diovascular mortality. Peritoneal dialysis patientshave more atherogenic lipoprotein profiles thanhemodialysis patients. Among the various athero-genic lipids and lipoproteins, lipoprotein (a)[Lp(a)] has received some attention. We foundserum Lp(a) levels are significantly higher in peri-toneal dialysis patients compared to hemodialysispatients ((51 ± 32 vs. 34 ± 23 mg/dL, p

Jeffrey J. Sands, MD, Scott Walker, OlliTuominen, PhD and Jeffery Maxwell, MS

Fresenius Medical Care North AmericaLexington, M.A.

Introduction:Delivering adequate dialysis coupled with the

widespread use of urea kinetic modeling hasfocused attention on the need to individualizedialysis prescriptions to deliver an eKt/v > 1.2(spKt/v > 1.4) for typical chronic dialysis pre-scriptions.This has rekindled interest in the processof dialysis and the options available to improvedialysis delivery.The new technologies embodied inUltraCareTM, including Optiflux® dialyzers,Autoflow (automated dialysate control system),AMP/OLC (on-line measurement of conductivi-ty clearance six [6] times during each dialysis)and the decision support built into the prescrip-tive screens in the Proton UKM (urea kineticmodeling) program, provide a new array of toolsto improve dialysis prescription and delivery. Thiscombination of technologies provides the infor-mation required to individualize dialysis prescrip-tions and takes full advantage of increaseddialysis efficiency while monitoring the influenceof variations in prescription parameters on ureaclearance.

History of Dialysis PrescriptionThe history of the dialysis prescription dates

back to the capabilities of the early Drake andTravenol dialysis machines. These early dialysismachines were only capable of delivering approx-imately 120 liters of dialysate during a treatment.Therefore, dialysate flow was set at approximately500 cc/min to allow for completion of a 4-hourtreatment.1 In these early days, small moleculeclearance was also limited by the available cellu-lose based membrane technology and thepatient’s ability to tolerate the large external vol-umes required by coils. Studies using thesetechnologies at a blood flow (Qb) of 200-300cc/min (the common blood flow in that era)showed that urea clearance curves reached aplateau when dialysate flow (Qd) was approxi-mately twice dialyzer blood flow (Qb) [i.e. Qd =2(Qb).] These experiences and limitations stillinfluence our dialysis prescription practices.With the advent of newer technology and a grow-ing realization of the importance of increasingurea clearance, average prescriptions haveevolved to a prescribed Qb of 400 cc/min and Qdof 800 cc/min becoming the most common dialysisprescription in the U.S. In light of these changes,it is useful to review the impact of dialysis pre-scription parameters on solute clearance.

Dialyzer Performance and KoaDialyzer performance has traditionally been

categorized by the membrane’s small molecule(urea) transport characteristics. Small moleculesmove primarily by diffusion. This movement is afunction of the dialyzer (membrane) mass transfer

coefficient for urea (Ko) and the surface area of thedialyzer (A).The product of these values (Koa) hasbeen utilized to describe dialyzer performance.Koa is a measure of the resistance to movementof molecules across the dialyzer. Barriers to mol-ecular transfer from blood to dialysate primarilyexist in three areas: (1) the blood-membraneinterface, (2) intrinsically within the membraneitself and (3) at the membrane-dialysate boundarylayer. This can be expressed as follows:

Rtotal = Rblood + Rmembrane + RdialysateKo = 1/Rtotal

Where R = resistance and Ko = the mass transfercoefficient for urea

The inverse of the sum of the resistance ateach of these levels combines to define the masstransfer coefficient or Koa.2 Traditionally, Koahas been felt to be a constant.Therefore, once Koawas defined for a dialyzer it was possible to predictdialyzer clearance at any combination of bloodflow (Qb) and dialysate flow (Qd). In actuality,various factors affect Koa. Recently several authorshave shown that Koa (urea) may change underdifferent conditions including differing hemat-ocrits, blood flows, dialysate flows and ultrafiltrationrates especially in high flux dialyzers.3 Increasesin hematocrit result in decreases in Koa. Proteinabsorption on the dialyzer membrane is also citedas one of the primary reasons that in vivo ureaclearance is approximately 15% less than predict-ed from the Koa. Increasing dialysate flow invitro from 500 to 800 in high flux dialyzers wasdescribed to result in a 10-14% increase in Koaurea that could potentially translate into signifi-cant increases in Kt/v urea. These differenceswere reported to predominantly affect small mol-ecules (urea), were dialyzer specific and differentin vivo than in-vitro. For example, Hauk et al4reported that removal rates for creatinine and B2microglobulin did not change when Qd wasincreased from 500 to 800 cc/min. Ouseph andWard5 reported that in vivo they saw no change inKoa with increases in Qb from 300-400 cc/min

D I A L Y S I S T I M E SPage 2

Advances in Hemodialysis Clearance: A Review

during in vivo testing. Increasing dialysate flowfrom 500 to 800 resulted in a 4.1- 7.1% increasein Koa in dialyzers with a cellulose acetate mem-brane.The cause of this change in Koa was felt tobe related to decreases in the dialysate boundarylayer resistance with increases in dialysate flow.The actual increase in urea removal withincreased dialysate flow is not as large as generallyimplied by the clearance measurement alone.Sigdell et al6 showed that equalizing the amountof urea removed at a Qd equal to Qb comparedwith that removed at a Qd of 2.5 x Qb would onlyrequire increasing dialysis time by approximately10%, yet would decrease dialysate consumptionover 50%.

Optiflux Technologies and Dialyzer ClearanceThe above issues helped form the basic con-

ception for designing the new Optiflux series ofdialyzers and the dialysate management (aut-oflow) and clearance measurement technologies(AMP/OLC) incorporated in the Fresenius2008H and K machines. Maldistribution of thedialysate flow can result in poorer performancethan expected. Koa will increase with increasingdialysate flow in dialyzers that are not optimizedfor dialysate side flow distribution. Recent workby Ronco et al7.8 helps illustrate some of theseissues. In convention hollow fiber dialyzers, bloodflow and dialysate flow are not evenly distributed.Blood flow is greater in the central fibers and lessat the periphery. Dialysate flow tends to stream inselected channels, thus decreasing the effectivesurface area of the dialyzer and creating areas ofstagnant flow. The Optiflux dialyzers alleviatethis by creating a moire or waved pattern of thedialysis hollow fibers (figure 1). This significantlyincreases clearance and decreases the effect of Qdchanges on Koa and clearance. We recently testedthe Optiflux 160 dialyzer urea clearance in 108patients in 7 outpatient facilities under two conditions: (1) at a Qd equal to approximately 1.5x Qb (as set in the autoflow software) and (2) ata Qd equal to 800 with Qb’s ranging from 250 –450 cc/min. Measured dialyzed clearancedecreased only 3.6% (2.1- 5.8) when Qd wasreduced from 800 cc/min to 1.5 Qb. This change

continued on page 8

D I A L Y S I S T I M E S Page 3

D I A L Y S I S T I M E Spublished by

Renal Research Institute, LLC

207 East 94th Street, Suite 303

New York, NY 10128

Telephone 212 360-4900 • Fax 212 360-7233

www.renalresearch.com

E D I T O R I A L C O M M I T T E E

Linda DonaldNathan Levin, M.D.

J. Michael Lazarus, M.D.Tom GrahamDavid Tigue

William Venus – contact person

To search past issues online, register to receive future issues, or submit articles or letters for publication, visit

www.renalresearch.com or e-mail dialysistimes@rriny.com

John MarkusSenior Vice President of Administration andCorporate ComplianceFresenius Medical Care North America

As an attorney, words are my tools and I amaccustomed to written documentation. I use let-ters to document my clients’ positions. I writepolicies to promote compliance with health careregulations. When I was in private practice, Idocumented my work on behalf of clients in six-minute intervals.

Accountants, likewise, are notorious fordemanding documentation of expenses and rev-enues. Office managers as well as corporate audi-tors want to see copies of receipts and back-up tojournal entries to prove that we spent or receivedthe precise sums recorded on company or part-nership books.

Both lawyers and accountants have a usefulrole to play in our society. But when they meetthe medical profession as government auditors orpublic prosecutors, considerable friction can arisefrom a failure to appreciate difference in customsand practice. Documentation of patient treat-ments and services often falls into this category,particularly in practice settings outside of a hos-pital. Too often, lawyers and accountants want toimpose a set of standards and experience on thecontent of medical records that is not necessarilyconsistent with the medical purposes for whichthe records were created in the first instance.

The fact is that auditors and prosecutorswant to see tangible (i.e., written) evidence that aservice was ordered, was medically justified, andwas furnished before authorizing payment. Thissounds simple enough, but it becomes problem-atic when one considers that most medicalrecords are designed not to justify reimburse-ment, but to facilitate medical communicationbetween health professionals who share a com-mon base of medical knowledge and do not feelcompelled take what they see as the unnecessarytime to separately document a medical thoughtprocess that would be obvious to a third yearmedical student. Thus a nephrologist who ordersa series of iron studies on a dialysis patient wouldnot think it necessary to explain the relationshipbetween anemia and ESRD in each patient chart.He or she might therefore be puzzled by requestsby government auditors to document the “med-ical necessity” of the obvious

This is not to say that the government lacksgood reasons for keeping a careful eye onMedicare expenditures. Experience has shownthat lax monitoring can allow serious abuses tooccur. The real question is one of balancing pro-gram integrity with proper patient care. Mostgovernment officials do their best to find theproper balance but in doing so are inevitablyinfluenced by their own professional experiences,

often as lawyers and accountants.This is the realityof health care in 2002 and it is incumbent uponphysicians and other health care providers tounderstand the system – and the important roleof medical documentation within the system – orrisk a fight that they almost certainly will not win.

Four examples affecting ESRD servicesillustrate this point.

(1) Physicians’ Monthly Capitation Payment(MCP). For the past two years, the Office ofInspector General (OIG) has been conductinga national audit of MCP payments to nephrol-ogists for routine care of ESRD patients coveredby Medicare. Dialysis clinics have received anumber of requests from OIG auditors fordocumentation of examinations and servicesfurnished to patients by the nephrologists with-in the dialysis facility. The OIG is apparentlylooking for documentation that the nephrolo-gists physically examined the patient eachmonth for which he or she received an MCPand that all of the routine professional servicescovered by the MCP were furnished in accor-dance with the medical needs of each patient.Since a large part of the physician’s work is typ-ically performed in the dialysis facility, the OIGrequests the documentation from the facility.If a physician has not documented his/herwork in the dialysis facility record, the facilitylikewise will be unable to produce an acceptablewritten record of the physician’s involvement,and the OIG may expand the scope of its auditand/or seek repayment from the physician forsome monthly capitation payments.

(2) Laboratory Test Orders. For some time,Medicare Part B carriers have been imposingrestrictions on the use of certain laboratory teststhrough the mechanism of Local MedicalReview Polices (LMRPs). Ostensibly developedin consultation with local practitioners, manylaboratory-related LMRPs appear out of touchwith current ESRD practice standards. Asnoted above, it may be difficult for a nephrologistto understand why frequent iron studies forESRD patients may be questioned by an auditoror why the dialysis clinic staff may be pesteringhim or her for a second diagnosis because theone originally selected was not on the list ofcodes designated as payable by an LMRP. Yetwithout a payable diagnostic code that isbacked up by written documentation in thepatient file, a laboratory claim for an other-wise medically appropriate service will likelybe denied. Of course, the claim may be paidon appeal if the ordering physician is pre-pared to reconstruct his or her decision-mak-ing process before an Administrative LawJudge, but this merely compounds the admin-istrative cost associated with an already over-burdened health care system.

(3) Special Transportation Services. U.S.Attorneys and the FBI (and recently the OIG

in its 2003 workplan) have been targetingambulance companies across the country foralleged billing abuses associated with unnec-essary ambulance and other special trans-portation services. Because the annual cost ofthrice-weekly ambulance service can be sub-stantial, transportation of dialysis patients toand from freestanding clinics has been a focusof these investigations. Typically, a dialysisclinic will receive a subpoena seeking medicalrecords for a list of patients receiving routineambulance transportation. Staff members,usually the social worker, will be interviewedby federal agents about these services. Didthe treating physician personally complete theMedicare Certificate of Medical Necessity(CMN)? Did the doctor or clinic receivekickbacks from the ambulance company inexchange for patient referrals? Could thepatients have been transported to the clinic byother, less expensive means?

While the target of these investigations is usu-ally the ambulette Company, doctors can bepulled into a criminal enforcement action ifthey fail to document the need for specialtransportation services or if the physicianimproperly delegates the task of completingthe section of the CMN that, by regulation, thephysician must complete personally. Claiming(or feigning) ignorance of the patient’s med-ical needs, some ambulance companies havetried to redirect the investigation toward thephysician. The consequences to a physicianwho prosecutors believe to have abetted afraudulent scheme by turning a blind eye orfailing to document medical need could be farmore serious than the loss of a few monthlycapitation payments.

(4) In-Patient Dialysis. Physicians ordering in-patient dialysis treatments to ESRD patients

Documentation – A Reality in the New Medical Environment

continued on page 8

D I A L Y S I S T I M E SPage 6

toneal dialysis at enrollment, and higher levels ofserum prealbumin, serum albumin, and serumcreatinine were associated with better survival inperitoneal dialysis patients.(18) Chertow et al con-firmed that prealbumin provides prognostic valuein hemodialysis patients, independent of albuminand other established predictors of mortality.(19)

Serum Prealbumin as an Acute Phase Reactant

Serum prealbumin is also known to be a negative acute phase reactant protein.(28) Thereappears to be an association between proteinenergy malnutrition and inflammatory state indialysis patients.(29) We and others have previous-ly reported that, for uncertain reasons, serumprealbumin is higher in peritoneal dialysis than inhemodialysis patients,(18;30) and that the (mortali-ty risk) predictive power of prealbumin in peri-toneal dialysis patients appears to be differentthan in hemodialysis,(18) possibly related to aninflammatory state independent of nutrition.Very recently we assessed the relationshipbetween C-reactive protein (CRP), a marker forinflammation, and several clinical and laboratoryvariables including prealbumin in peritoneal dial-ysis patients. Also, we enrolled 45 peritoneal dial-ysis patients from June 2001 and followed themup to January 2002. On enrollment, demograph-ics and clinical data were collected. Serum preal-bumin and C-reactive protein were assayed byimmunoturbidimetric method. Mean age was54±15 (SD) years; 80% were African-American;56% were female; and 31% were diabetic. Meanprealbumin and CRP were 42±12 mg/dL and8.99±24 mg/L, respectively. Interestingly, serumprealbumin correlated inversely with urinary pro-tein loss (r=-0.5, P=0.012) and total (urinary +effluent) protein loss (r=-0.34, P=0.024). Notsurprisingly, serum prealbumin was directly cor-related with nutritional markers such as albumin(r=0.59, P30mg/dL was significantly (P=0.001) higher thanthat of patients with prealbumin ≤30 mg/dL.Cumulative survival adjusted for race, gender,diabetes, previous months on peritoneal dialysis,enrollment serum creatinine and by humanimmunodeficiency virus (HIV) also showed similarresults, i.e., patients with enrollment serum pre-albumin more than 30 mg/dL had better survival(P=0.02). By univariate Cox regression analysis,age and presence of diabetes were positive predic-tors of mortality in peritoneal dialysis patients,while African ancestry, more months on peri-

end-stage renal disease patients undergoingmaintenance hemodialysis has recently been val-idated by several workers.(21-23) We have beenstudying the usefulness of this promising methodin prospective cross sectional and longitudinalnutritional assessments of peritoneal dialysispatients. We also are comparing BIA parameterswith serum nutritional markers such as albuminand prealbumin within dialysis patients. We haveprospectively examined the relationship of BIAindexes to the nutritional state and survival in 45peritoneal dialysis patients from November 2000to April 2001 and followed up to January 2002.On enrollment, BIA (BIA-101; RJL/Akron,Clinton Twp, MI, USA) was performed andblood was analyzed monthly for biochemicalmarkers. The mean age was 50 ± 15 (SD) years.Fifty-six percent were female and 24% percent ofthe patients were diabetic. Mean body massindex was 25.7 ± 5.1 kg/m2. Mean resistance,reactance, capacitance and phase angle were 524± 106 Ohms, 57 ± 20 Ohms, 678 ± 223 picofarads and 6.2 ± 1.7 degrees, respectively.Diabetic patients had lower capacitance (555 vs.713 pico farads, P= 0.007) and phase angle (5.35vs. 6.4, P=0.05) than non-diabetics. Lower val-ues of phase angle and capacitance in diabeticpatients may imply poorer nutritional status.During the study period, four patients died.Patients who survived had a significantly highercapacitance (697 vs. 486 pico farads, P=0.07)and higher phase angle (6.34 vs. 4.65 degrees,P=0.008) compared to those who did not sur-vive. The Kaplan-Meier method was used tocompute observed survival. The cumulativeobserved survival of peritoneal dialysis patientswith an enrollment phase angle greater than orequal to 6 degrees was significantly (P=0.01)higher than that of patients with a phase angleless than 6. All deaths occurred in patients withphase angle less than 6. Reactance was directlycorrelated with albumin (r=0.52, P

D I A L Y S I S T I M E S Page 7

the only predictor of phase angle in peritonealdialysis patients. In conclusion, BIA indexesreflect nutritional status in peritoneal dialysispatients and may be useful in monitoring nutri-tional interventions in this population.(24) It hasbeen reported that BIA is more sensitive thananthropometry in detecting alterations in bodycomposition of children on peritoneal dialysis.(25)The usefulness of BIA analysis in the assessmentof body composition and nutritional status ofperitoneal dialysis patients has recently beenreported by several other authors.(26; 27)

SummaryIn summary, accurate assessment of nutri-

tional status is important to improve survival ofperitoneal dialysis patients. Serum prealbumin isa useful parameter to follow the nutritional statusof peritoneal dialysis patients. However, as preal-bumin is a negative reactant protein, its level isdecreased regardless of optimal calorie intake duringinflammatory processes in peritoneal dialysis patients.Prealbumin is strongly and inversely correlatedwith CRP in peritoneal dialysis patients. Prealbuminis a reliable marker of nutritional status providedinflammatory status is considered. BIA indexesreflect nutritional status in peritoneal dialysis patients,and may be useful in monitoring nutritionalintervention. Among all the BIA parameters,phase angle may be the most important indicatorof nutritional status. Patients with lower phaseangle values should receive closer medical atten-tion. Body composition analysis by BIA should beincluded as a measure of nutritional status in theregular follow up of peritoneal dialysis patients.Improving survival and the quality of life of peri-toneal dialysis patients may help to increasepatient enrollment in this modality.

The above studies may help educate us, ourtrainees, and our patients. What else can we do toreverse the decline of continuous ambulatoryperitoneal dialysis?

Possible Ideas for Reversing the Trend inPeritoneal Dialysis1) More basic and clinical research to improve

peritoneal dialysis delivery.2) More rigorous nephrology trainee education in

peritoneal dialysis and greater peritoneal dialy-sis experience required for Board certification.

3) Considering peritoneal dialysis as an interimmodality, i.e. initial peritoneal dialysis for severalyears to extend and preserve residual renal func-tion, while at the same time placing a primary AVfistula for longer-term use thereby avoiding theconsiderable risks of temporary catheter access.

4) More clinical research to elucidate risk profilesunique to peritoneal dialysis (as opposed to themore commonly available hemodialysis data),identifying patients at higher morbidity and mor-tality risk and potentially improving survival.

5) Greater emphasis on early pre-ESRD patienteducation regarding dialysis modality choicesby well-informed multidisciplinary renal team.

Emphasize:6) Independence - More center visits per week in

hemodialysis, just once per month usually inperitoneal dialysis, and ease of personal travelin peritoneal dialysis.

7) Fewer vascular interventions that may result infewer hospitalizations.

19. Chertow GM, Ackert K, Lew NL, et al. Prealbumin is asimportant as albumin in the nutritional assessment ofhemodialysis patients. Kidney Int 2000;58:2512-7.

20. Lukaski HC, Johnson PE, Bolonchuk WW, et al.Assessment of fat free mass using bioelectrical impedancemeasurements of the human body. Am J Clin Nutr1985;41:810-7.

21. Chertow GM, Lowrie EG,Wilmore DW, et al. Nutrtionalassessment with bioelectrical impedance analysis in main-tenance hemodialysis patients. J Am Soc Nephrol1995;6:75-81.

22. Ikizler TA, Wingard RL, Harvell J, et al. Association ofmorbidity with markers of nutrition and inflammation inchronic hemodialysis patients:A prospective study. KidneyInt 1999;55:1945-51.

23. Stall SH, Ginsberg NS, DeVita MV, et al. Comparison offive body-composition methods in peritoneal dialysispatients. Am J Clin Nutr 1996;64:125-30.

24. Fein PA, Gundumalla G, Jorden A, et al. Usefulness ofbioelectrical impedance analysis in monitoring nutritionstatus and survival in peritoneal dialysis patients. AdvPerit Dial 2002;18.

25. Edefonti, A., Picca, M., Damiani, B., et al. Prevalence ofmalnutrition assessed by bioimpedance analysis andanthropometry in children on peritoneal dialysis. PeritDial Int 21, 172-179. 2001.

26. Kanazawa Y, Nakao T, Matsumoto H, et al. Serial changesin body composition in patients with chronic renal failureon peritoneal dialysis. Nippon Ronen Igakkai zasshi2001;43:589-94.

27. Passadakis, P., Sud, K., Dutta, A., et al. D. Bioelectricalimpedance analysis in the evaluation of the nutritional sta-tus of continuous ambulatory peritoneal dialysis patients.Adv Perit Dial 15, 147-152. 1999.

28. Ritchie RF, Palomaki GE, Neveux LM, et al. Referencedistributions for the negative acute-phase proteins, albu-min, transferrin, and transthyretin: a comparison of a largecohort to the world’s literature. J Clin Lab Anal1999;13:280-6.

29. Kalantar-Zadeh K, Kopple JD. Relative contribution ofnutrition and inflammation to clinical outcome in dialysispatients. Am J Kidney Dis 2001;38:1343-50.

30. Goldwasser P, Feldman JG, Barth RH. Serum prealbuminis higher in peritoneal dialysis than in hemodialysis: Ameta-analysis. Kidney Int 2002;62:276-81.

8) Better tolerated by the elderly and debilitatedpatients.

Above all, we need enthusiastic and informa-tive presentations to our pre-ESRD and ESRDpatients that truly come from the mind and heart(with genuine conviction). We have patients onperitoneal dialysis for over 15 years, and webelieve in the merits of this modality.This can becontagious in instilling confidence that thepatients can easily discern. The present nationaldownward trend, thus, can be reversed. All weneed is perseverance and faith in what we areproposing to those entrusted to our care.

AcknowledgmentsThis work was supported in part by grants

from the Kidney and Urology Foundation ofAmerica, the Nephrology Foundation ofBrooklyn, the Avram Center for Kidney Diseases,and the research and teaching arm of the RenalResearch Institute.

References1. United States Renal Data System. 2001 Annual Data

Report. 2001.2. Collins AJ, Hao W, Xia H, et al. Mortality risks of peritoneal

dialysis and hemodialysis. Am J Kidney Dis 1999;34:1065-74.3. Vonesh EF, Moran J. Mortality in end-stage renal disease:

A reassessment of differences between patients treatedwith hemodialysis and peritoneal dialysis. J Am SocNephrol 1999;10:354-65.

4. Avram MM. How can cardiac death be reduced in dialysispatients. Semin Dial 2002;15:26-9.

5. Avram MM, Sreedhara R, Patel N, et al. Is an elevated levelof serum lipoprotein (a) a risk factor for cardiovascular dis-ease in CAPD patients? Adv Perit Dial. 1996;12:266-71.

6. Avram MM, Fein PA, Antignani A, et al. Cholesterol andlipid disturbances in renal disease: The natural history ofthe uremic dyslipidemia and the impact of hemodialysisand peritoneal dialysis. Am J Med 1989;87:55N-60N.

7. Avram MM, Goldwasser P, Burrell DE, et al. The uremicdyslipidemia: a cross-sectional and longitudinal study. AmJ Kidney Dis. 1992;20:324-35.

8. Avram MM, Goldwasser P, Erroa M, et al. Predictors ofsurvival in continuous ambulatory peritoneal dialysis patients:the importance of prealbumin and other nutritional andmetabolic markers. Am J Kidney Dis 1994;23:91-8.

9. Avram MM, Mittman N, Bonomini L, et al. Markers forsurvival in dialysis: A seven year prospective study. Am JKidney Dis 1995;26:209-19.

10. Avram MM, Sreedhara R, Fein PA, et al. Survival ofhemodialysis and peritoneal dialysis over 12 years withemphasis on nutritional parameters. Am J Kidney Dis2001;37:S77-S80.

11. Sreedhara R, Fein PA,Thomas A, et al. Five year study ofdialysis dose in peritoneal dialysis patient survival. J AmSoc Nephrol 1998;9:302A (abstr).

12. Sreedhara R, Fein PA, Tachopoulou O, et al. Peritonealdialysis adequacy & mortality:A five year study. J Am SocNephrol 1999;10:322A-3A (abstr).

13. Avram MM, Bonomini LV, Sreedhara R, et al. Predictivevalue of nutritional markers (albumin, creatinine, choles-terol, and hematocrit) for patients on dialysis for up to 30years. Am J Kidney Dis 1996;28:910-7.

14. Avram MM, Feinfeld DA, Huatuco AH. Search for theuremic toxin: Decreased motor-nerve conduction velocityand elevated parathyroid hormone in uremia. N Engl JMed 1978;298:1000-3.

15. Avram, MM, Mittman, N., Myint, M. M., et al.Importance of low serum intact parathyroid hormone as apredictor of mortality in hemodialysis and peritoneal dial-ysis patients: 14 years of prospective observation. Am JKidney Dis 38, 1351-1357. 2001.

16. Ingenbleek Y, De Visscher M, De Nayer P. Measurementof prealbumin as index of protein-calorie malnutrition.Lancet 1972;2:106-9.

17. Mears A. Outcomes of continuous process improvementof a nutritional care program incorporating serum preal-bumin measurements. Nutrition 1996;12:479-84.

18. Mittman N, Avram MM, Oo KK, et al. Serum prealbu-min predicts survival in hemodialysis and peritoneal dial-ysis: 10 years of prospective observation. Am J Kidney Dis2001;38:1358-64.

was in complete agreement with the predictivemodel. Koa did not change with increases indialysate flow. This in vivo data again confirmsthe efficacy of the Optiflux design to increase dia-lyzer clearance over the complete range of bloodand dialysate flows while minimizing the dialysatestreaming effect described by Ronco. When com-bined with Fresenius polysulfone membranetechnology, this reconfiguration forms the basisfor the increased clearance seen with the Optifluxseries of dialyzers. The stability of Koa alsoallows continued use of Koa as a basis for defin-ing individual dialysis prescriptions and supportsthe improvements in urea clearance when usinglower dialysate flows.

Treatment to Treatment Variability Another important issue is the large treat-

ment to treatment and patient to patient variabilityin urea clearance despite identical dialysis pre-scription. Our previous studies have confirmedDr. Gotch’s teaching that there is an approxi-mately 15% treatment-to-treatment variance inurea clearance in the same patient on the samedialysis prescription. Differences between patientsare even greater. This reinforces the importanceof measuring dialysis adequacy with every dialysistreatment. By utilizing the AMP/OLC system, anyvariation in delivered urea clearance is identifiedand can be corrected immediately. Predictedclearance becomes a prescription guide while

continued from page 2

Advances in Hemodialysis...

D I A L Y S I S T I M E SPage 8

same as those developed by the medical profes-sion for efficient shorthand communication ofvital medical information. Finally, they shouldunderstand that the government is serious aboutMedicare program integrity and that failure tomeet documentation standards will open themto costly distractions of their professional timeand possibly their reputations as well.

in a hospital setting have several billingoptions. Some codes pay additional reim-bursement if the physician is physically pre-sent during the treatment. When a physicianselects one of these codes, he or she shouldbe careful to document their presence duringthe procedure and that their presence wasmedically important. If there are no physi-cian notes in the patient file an auditor mayquestion a nurse about whether the physicianwas present during the procedure. Again,the consequences to a physician who isunable to confirm his or her presence duringthe treatment could be serious.

The common thread in each of these exam-ples is the reliance of government auditors andprosecutors on written evidence in the patientmedical record. It has been said, “if a service isnot documented, it did not happen.” This maybe catchy, but as a serious statement of law orformal policy it is too cynical and does a disser-vice to the medical profession as well as to oth-erwise well-intentioned government officials.Yetit may describe the personal attitude of some ofthe individual lawyers and accountants who aredrawn to the enforcement side of health care.Lacking medical training, they may be neitherwilling nor qualified to examine a medical file tounderstand whether a patient is receiving propermedical care. When in doubt, they may beinclined to question a payment that lacks cleardocumentation and let the appeals processdetermine the correct result.

To conclude, so long as Medicare reimbursesESRD services on a fee for service basis, physi-cians should expect increasing demands formedical record documentation. They shoulddocument all patient encounters and treatmentdecisions in writing in the patient medical fileand be prepared to deal with occasional chal-lenges by non-physicians to their medical judg-ment. They should understand that thedocumentation standards used by governmentauditors and prosecutors are not necessarily the

direct measurement confirms the delivery of adefined minimum Kt/V.

ConclusionThese new technologies allow us to establish

a new standard of care for dialysis patients thatfocus on individualized dialysis prescriptionsand measured dialysis delivery to guaranteeachieving adequacy goals. This is accomplishedby using dialyzers (Optiflux) that are specificallydesigned to increase small and large moleculeclearance while more efficiently matchingdialysate flow to surface area. Coupling the useof such dialyzers with systems to prescribe(UKM) and measure actual dialysis deliverywith each treatment (AMP/OLC) furtherenhance the ability to achieve adequacy goals.These improvements in process provide physi-cians with the tools necessary to ensure thatpatients receive the appropriate dialysis prescrip-tion and prescribed outcome reliably with eachand every dialysis treatment.

References1) Maher J; Replacement of Renal Function. 3rd edition;

Klawer academic Publishers 19892) Clark WR, Gau D; Properties of Membranes Used for

Hemodialysis. Seminars in Dialysis V15, N1 (2002) 191-1953) Leypoldt JK, Cheung AK; Increases in mass transfer-area

coefficients and urea Kt/V with increasing dialysate flowrate are greater for high-flux dialyzers. Am J Kidney Dis2001 Sep;38(3):575-9

4) Hauk M, Kuhlmann MK, Riegel W, Kohler H.; In vivoeffects of dialysate flow rate on Kt/V in maintenancehemodialysis patients. Am J Kidney Dis 2000Jan;35(1):105-11

5) Ouseph R, Ward RA.; Increasing dialysate flow rateincreases dialyzer urea mass transfer-area coefficients dur-ing clinical use. Am J Kidney Dis 2001 Feb;37(2):316-20

6) Sigdell JE, Tersteegen B.; Studies concerning the opti-mization of dialysate consumption. Nephron1995;71(4):401-6

7) Ronco C, Scabardi M, Goldoni M, Brendolan A, CrepaldiC, La Greca G.; Impact of spacing filaments external tohollow fibers on dialysate flow distribution and dialyzerperformance. Int J Artif Organs 1997 May;20(5):261-6

8) Ronco C, Brendolan A, Crepaldi C, Rodighiero M ,Scabardi M; Hemodialyzers Analyzed by ComputerizedHelical Scanning Technique. J Am Soc Nephrol 13:S53–S61, 2002

continued from page 7

Advances in Hemodialysis...continued from page 3

Documentation - A Reality...

Top 3 sets of answers will receive the following awards in conjunction with the 5th Annual International Conference on Dialysis in Miami,January 29-31, 2003.

1. Complimentary air travel, hotel accommodations, and registration for 3 days

2. Complimentary hotel accommodations and registration for 3 days

3. Complimentary registration for 3 days

Contestants must answer or respond to any 3 ofthe following 5 questions (no more than 250words each):

1.Why does hypertension not appear to be a riskfactor for mortality in US dialysis patients?

2.Why is dialysis mortality lower in France &Japan than in the U.S.?

3.Why are there differences in SMR in differentparts of the USA?

4.What do the various nephrology societies dofor you? (NKF, ASN, RPA, ASAIO, ISN)

5. Do you praise or criticize the concept of disease management for kidney disease? Why?

An independent panel of physicians from the International Conference ProgramCommittee, including members from the ASN, ISN, RPA, and NKF, will review contestant submissions. Awards will be announced in the December 2002 issue of Dialysis Times.

Submissions should be sent to:Renal Research InstituteAttn: DT Trivia207 E. 94th Street, Ste. 303New York, NY 10128

WIN A TRIP TO MIAMI!Dialysis Times Renal Trivia

Since 1997, HDCN, an on-line nephrology journal,has been the official educational program of the AmericanSociety of Nephrology (ASN) and the Renal PhysiciansAssociation (RPA.) HDCN pioneered the idea of postingtalks from nephrology meetings on the internet. Each week,1-4 new talks are posted, plus a larger number of audio filesthat can be downloaded for local listening in the car. Alongwith 16 or so abstracts, specific articles are identified andlisted in areas of key clinical importance from the mostrecent ASN meeting. HDCN now offers on-line CME’sand CE’s for nurses, with on-line certificate generation.Many parts of HDCN are free, while other sections requirea subscription fee of $75.00 to resource. For more infor-mation on HDCN or register for the FREE area, visitwww.hdcn.com/reg.htm.

What’s New?Aetna & HIP of NY Sign Disease ManagementAgreements with Optimal Renal Care

Optimal Renal Care, LLC, a disease man-agement company specialized in providing caremanagement to health plans and their memberswith kidney disease, recently signed agreementswith Aetna and Health Insurance Plan of NewYork (HIP of NY) to provide disease manage-ment services to their members with ESRD.Both Aetna and HIP, along with their physiciansand members with kidney disease, will haveaccess to their individual multidisciplinary teamof professionals focused on ESRD to improveoverall quality and patient satisfaction.