OPTIMIZING OUTCOMES ON PERITONEAL DIALYSIS: John Burkart, M.D. Wake Forest University Baptist Medical Center Winston Salem, NC USA 07/12/2008.

OPTIMIZING OUTCOMES ON OPTIMIZING OUTCOMES ON PERITONEAL DIALYSIS: PERITONEAL DIALYSIS:

OPTIMIZING OUTCOMES ON OPTIMIZING OUTCOMES ON PERITONEAL DIALYSIS: PERITONEAL DIALYSIS:

John Burkart, M.D.John Burkart, M.D.

Wake Forest University Baptist Medical CenterWake Forest University Baptist Medical Center

Winston Salem, NC USAWinston Salem, NC USA

07/12/200807/12/2008

CONFLICT OF INTERESTJohn Burkart

CONFLICT OF INTERESTJohn Burkart

Advisory Boards ---Advisory Boards ---

Grants ----------------Grants ----------------

Honoraria -----------Honoraria -----------

Chief Medical OfficerChief Medical Officer

Baxter, NxStage, Genzyme, Baxter, NxStage, Genzyme, CMSCMS

NIH, Baxter, Genzyme, NIH, Baxter, Genzyme, Abbott, NxStage, WatsonAbbott, NxStage, Watson

Baxter, FreseniusBaxter, Fresenius

14 dialysis units 14 dialysis units (CHD, PD, HHD)(CHD, PD, HHD)

CONFLICT OF INTERESTCONFLICT OF INTEREST

Passion for home dialysis (PD and HHD)Passion for home dialysis (PD and HHD) Course director PDUsCourse director PDUs Involved in Frequent HD study (nocturnal)Involved in Frequent HD study (nocturnal) Medical director 14 units (until 2008 CFC)Medical director 14 units (until 2008 CFC) In the Wake Forest Outpatient Units about 13% of In the Wake Forest Outpatient Units about 13% of

patients on Home dialysispatients on Home dialysis About 30% of my patients on Home DialysisAbout 30% of my patients on Home Dialysis

TOPICS TO BE COVEREDTOPICS TO BE COVERED

Outcomes for PD are improving – medical Outcomes for PD are improving – medical data suggests we should do more PD!data suggests we should do more PD!

Given medical data that tends to favor PD, Given medical data that tends to favor PD, why are we not doing more PD?why are we not doing more PD?

RecommendationsRecommendations


Outcomes for PD are improving – medical Outcomes for PD are improving – medical data suggests we should do more PD!data suggests we should do more PD!

Given medical data that tends to favor PD, Given medical data that tends to favor PD, why are we not doing more PD?why are we not doing more PD?

RecommendationsRecommendations

Attempted to randomize patients to PD or HDAttempted to randomize patients to PD or HD Eligible patients were given extensive informed consentEligible patients were given extensive informed consent Informed consent included explanation of PD and HDInformed consent included explanation of PD and HD

PATIENT MODALITY CHOICE:Lessons from an Attempted Prospective Randomized Trial


0

50

100

150

200

250

300

350

400

Agreed toRandomization

Wanted HD Wanted PD

Agreed to Randomization Wanted HD Wanted PD

Korevaar JC et al KI 2003; 64:222-228

After 3 ½ years, only 38/735 eligible agreed to randomization!

ATTEMPTED PRCT TO EVALUATE SURVIVAL ON PD vs. HDATTEMPTED PRCT TO EVALUATE SURVIVAL ON PD vs. HD

0

100

200

300

400

500

600

700

800

# eligible

# pts

773 eligible patients773 eligible patients Only 38 were randomizedOnly 38 were randomized Results underpoweredResults underpowered Survival better on PDSurvival better on PD Korevaar JC et al KI 2003; 64:222-228

WHAT DO OBSERVATIONAL COHORT STUDIES SHOW US?WHAT DO OBSERVATIONAL COHORT STUDIES SHOW US?

Caveats, limitations thereof Caveats, limitations thereof acknowledgedacknowledged

COMPARISON OF HD AND PD SURVIVAL IN THE NETHERLANDS

COMPARISON OF HD AND PD SURVIVAL IN THE NETHERLANDS

Methods:Methods: 20,687 patients started RRT between 1/1/87 and 12/31/0220,687 patients started RRT between 1/1/87 and 12/31/02 Excluded data on: Transplant first 90 days; HD unit < 20 Excluded data on: Transplant first 90 days; HD unit < 20

pts or PD unit < 5 pts; < 18 years oldpts or PD unit < 5 pts; < 18 years old Final analysis – 47 centers; 16,643 total: 10,841 on HD, Final analysis – 47 centers; 16,643 total: 10,841 on HD,

5802 on PD.5802 on PD. Analysis univariate and multivariate Cox modelAnalysis univariate and multivariate Cox model

Liem et al, KI 2007; 71:153-158Liem et al, KI 2007; 71:153-158

UNAJUSTED PATIENT SURVIVALPD vs HD - Netherlands

Liem et al, KI 71:153-158, 2007

HD and PD Comparison of Adjusted Mortality Rates According to the

Duration of Dialysis

METHODS: All consecutive new RRT starts Survived at least 3 months on HD (baseline) 742/947 HD patients, 480/582 PD patients Follow up till 9/1/02 Analysis both in As-Treated (AT) and intend to treat (ITT)

manner For AT analysis, deaths assigned to original Rx if occurred

within 60 days of transfer

Termorshuizen et al JASN 2003; 14:2851-2860Termorshuizen et al JASN 2003; 14:2851-2860

RELATIVE RISK OF DEATHHD vs PD

Termorshuizen et al. JASN 14: 2851-2860; 2003

SURVIVAL RISK ON ESRDHD vs PD

METHODS: Incidence data from US medicare patients

initiating dialysis between 1995 and 2000 398,940 patients Proportional hazards regression Stratified by cause of ESRD, presence of

comorbidities, age Proprtional and non-porportional hazards methods

were used to estimate relative risk of HD:PD

Vonesh et al KI 2004; 66:2389-2401

RELATIVE RISK OF DEATHPD vs. HD by Diabetic Status – No Comorbidity

Vonesh et al KI 2004; 66:2389-2401

Vonesh et al KI 2004; 66:2389-2401

RELATIVE RISK OF DEATHPD vs. HD by Diabetic Status – With Comorbidity

Vonesh et al KI 2004; 66:2389-2401

Vonesh et al KI 2004; 66:2389-2401

ADJUSTED FIVE YEAR SURVIVAL

by modality & primary diagnosis

Incident dialysis patients; adjusted for age, gender, & race. ESRD patients, 1996, used as reference cohort. Modality determined on first ESRD service date; excludes patients transplanted or dying during the first 90 days (five-year survival probabilities noted in parentheses).

Fig 6.3 USRDS Annual report AJKD 2006

First-year mortality rate: with basic vs. composite adjustments

Figure ei.1

Incident dialysis patients. Basic adjustment: age, gender, race, & primary diagnosis. Composite adjustment: age, gender, race, primary diagnosis, comorbidities, BMI, hemoglobin, & eGFR. Comorbidities & laboratory information from the Medical Evidence form. Incident dialysis patients, 2004, used as reference cohort.

2007 USRDS Report

ADJUSTED FIVE-YEAR SURVIVAL:

by first modality USRDS 2007 Figure p.25

Incident dialysis patients & patients receiving a first transplant in the calendar year, 1991–1995 & 1996–2000 combined; adjusted for age, gender, race, & primary diagnosis. Incident ESRD patients, 1996, used as reference cohort. Dialysis patients are followed from day 90 after initiation; transplant patients are followed from the transplant date.

Point where relative risk crosses has moved to right!

91-95

96-00

RELATIVE RISK OF DEATH:PD vs HD --ANZDATA

MacDonald et al. JASN 20:155-163; 2009MacDonald et al. JASN 20:155-163; 2009

ANZDATA REGISRTYRelative Risk of Death PD vs HD

MacDonald et al. JASN 20:155-163; 2009

PERITONITIS RATES ARE HIGH IN ANZDATA

Johnson AJKD 2009: 53:290-297Johnson AJKD 2009: 53:290-297

SUMMARY OF EPIDEMIOLOGICAL OBSERVATIONAL STUDIES

Population based cohort studies suggest: At initiation of dialysis survival risk favors PD Relative risk for PD vs HD changes over time Survival advantage for PD less robust for:

Elderly, patients with DM or comorbidities Survival advantage varies from country to country All cohorts show same trendsThese are Observational cohort studies These studies have limitations do not establish

casuality and are hypothesis generating

Geographic variations in unadjusted incident rates (per million population), by first modality & HSA:

PD PATIENTS, 1994-1995Figure 4.4 (continued)

Incident ESRD patients, by HSA, unadjusted. Excludes patients residing in Puerto Rico & the Territories.

2007 USRDS Report

Geographic variations in unadjusted incident rates (per million population), by first modality & HSA:

PD PATIENTS, 2004-2005Figure 4.4 (continued)

Incident ESRD patients, by HSA, unadjusted. Excludes patients residing in Puerto Rico & the Territories.

2007 USRDS Report

Adjusted admissions for principal diagnoses, by modality Figure 6.5 (Volume 2)

Adjusted admissions for principal diagnoses, by modality Figure 6.5 (Volume 2)

Period prevalent ESRD patients; adjusted for age, gender, race, & primary diagnosis. ESRD patients, 2005, used as reference cohort.

INFECTION RELATED PATIENT TRANSFER FROM PD to HD

DECREASING

INFECTION RELATED PATIENT TRANSFER FROM PD to HD

DECREASING

0

1

2

3

4

5

6

7

8

All New to Dialysis Transfer from HD

Pat

ien

t T

ran

sfer

(%

)

199920002001

Guo, Mujais. Kidney Int. 2003;64 (suppl 88):S1-S10.

TOPICAL MUPIROCIN REDUCES ESI/PERITONITIS

0.39

0.19

0.61

0.42

0.075

0.0470

0.1

0.2

0.3

0.4

0.5

0.6

0.7

ESI Peritonitis Catheter loss

Control

Mupirocin

P=0.19

P<0.001 P=0.003

Casey, Burkart PDI 2000

Mupirocin prophylaxis reduces S aureus peritonitisMupirocin prophylaxis reduces S aureus peritonitis

0

0.05

0.1

0.15

0.2

0.25

intranasalmupirocin

intranasalmupirocin

exit sitemupirocin

exit sitemupirocin

control prophylaxisS aureus peritonitis/year

Perez-Fontan The Mupirocin Study Group

Bernardini Thodis

Double Blinded Randomized Trial of Mupirocin vs Gentamicin Exit Site CreamDouble Blinded Randomized Trial of Mupirocin vs Gentamicin Exit Site Cream

0

0.1

0.2

0.3

0.4

0.5

0.6

mupirocin gentacmicin

sterile

yeast

Other GN

P aerug

other Grpos

S aureus

Gentamicin cream reduced GNR peritonitis, compared to mupirocin

Piraino, Bernardinin - Presented at ISPD 2004 Congress

PERITONITIS

PERITONITIS USUALLY RESOLVES WITHOUT COMPLICATIONSPERITONITIS USUALLY RESOLVES WITHOUT COMPLICATIONS

0

10

20

30

40

50

60

70

80

90

Resolved Hospital. CatheterRemoved

Transfer Death

CoagNS S aureus nP-GNR% all episodes

Bunke et al V52;2 p524 KI 1997

1.1

1.0

0.9

0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0

83 85 87 89 91 93 95 97 99 01 03 05

Y set introduced

Double bag system

S aureus prophylaxesintroduced

Spike assist devicefor cycler patients

Infection Rates Reduced In PDInfection Rates Reduced In PDAs Innovations and Protocols Are IntroducedAs Innovations and Protocols Are Introduced

Infection Rates Reduced In PDInfection Rates Reduced In PDAs Innovations and Protocols Are IntroducedAs Innovations and Protocols Are Introduced

Bender FH et al. KI, 2006;70(S):S44-S54.

Peritonitis Episodes per Dialysis Year

Per

iton

itis

Epi

sode

s/P

atie

nt

Yea

r

WHAT ACCESS DO YOU HAVE IN YOUR UNIT?

WHAT ACCESS DO YOU HAVE IN YOUR UNIT?

Prevalent vs. IncidentPrevalent vs. Incident

PD - peritonitis

Bacteremia

WFOPD data 2004-2005

ADJUSTED MORTALITY AFTER FIRST SEPTICEMIC EVENT

ADJUSTED MORTALITY AFTER FIRST SEPTICEMIC EVENT

Months6 12 18 24 30 36 42 48 54 60

Adj

.mor

talit

yra

te p

er 1

00 p

tye

ars

0

20

40

60

80

100

120

140

160

With sepsis

Without sepsis

Incident dialysis patients (90-day rule), 1996–1999 combined; adjusted for modality, age, gender, race, & primary diagnosis. Patients with Medicare as a secondary payor or enrolled in an HMO on day 90, & those with septicemia claims overlapping the start date of the followup period, are excluded. Reference group: patients without sepsis.

USRDS:2003 ADR

INFECTION RATES PD vs HDINFECTION RATES PD vs HD

Remember 82% of all new CHD patients start with a Remember 82% of all new CHD patients start with a catheter! catheter! (USRDS 2008 report)(USRDS 2008 report)

Infection rates higher with Tunneled vascular catheters Infection rates higher with Tunneled vascular catheters than with PD (peritonitis)than with PD (peritonitis)

Bacteremia with Tunneled catheters have been increasing!Bacteremia with Tunneled catheters have been increasing! Bacteremia associated with increased RRD for 2 to 3 yearsBacteremia associated with increased RRD for 2 to 3 years Up to 30% of patients with catheters have 1 episode of Up to 30% of patients with catheters have 1 episode of

bacteremia by 6 months!bacteremia by 6 months! Peritonitis almost never associated with bacteremia.Peritonitis almost never associated with bacteremia.

- One Size Does Not Fit All! - Must Have Flexibility in Exit-Site Placement

- One Size Does Not Fit All! - Must Have Flexibility in Exit-Site Placement

PresternalPresternal Upper Abdominal Upper Abdominal Mid-abdominalMid-abdominal Lower AbdominalLower Abdominal

Crabtree JH et al. Am Surg. 2005;71:135-143.

PD CATHETERS HAVE A HIGH SUCCESS RATE!

Probability of Remaining Free of Mechanical Flow ObstructionAt 24 Months Significantly Increased by Newer Techniques

P < 0.0001 vs open or basic technique

Open Dissection

Basic Laparoscopy

Advanced Laparoscopy

0

25

50

75

100

% P

rob

abili

ty

82.5% 87.2%99.5%

Cumulative probability of multiple catheter placements

Figure 1.9 (Volume 2)

Medicare: hemodialysis patients who initiate dialysis at age 67 or older during the year specified. Includes those with Medicare as primary payor during the two years prior to initiation & through the first six months of ESRD; pre-ESRD claims used for months prior to initiation date. Medstat (EGHP): patients with first date of regular & continuous dialysis in 2000 or 2005, regardless of age. Only one year of claims prior to the start of dialysis was available for the 2000 cohort.

DOES PRETRANSPLANT MODALITY INFLUENCE ALLOGRAFT OR PATIENT

SURVIVAL?

Review of USRDS Records 1990-2000, Cox model

RESULTS: Patients transplanted from PD predicted:

3% lower risk of graft failure 6% lower risk of recipient death Data persist even if predominant pre-transplant

modality (>50% of dialysis time was used rather than immediate)

Goldfarb-Rumyantzev et al, AJKD 46:537, 2005

PRETRANSPLANT DIALYSIS MODALITY AND RISK OF DELAYED

GRAFT FUNCTION

More likely to have delayed graft function if transplanted from HD. 50% vs 24% on PD

Mean time to being dialysis free7.8+3.9 days PD vs 16.8+8.0 days HD

Perez FM et al. PDI 16:48-51, 1996

More likely to have delayed graft function if transplanted from HD. 50.4% vs 23.1% on PD

Vanholder R et al. AJKD 33:934-940, 1999

MEDICAL OUTCOMESPD vs HD - Summary

Early survival advantage for PD Potential for less serious Infections with PD Graft and Patient survival for transplant

favor use of PD Quality of life issues – favor PD Cost Issues – favor PD

TOPICS TO BE COVERED

Outcomes for PD are improving – medical data suggests we should do more PD!

Given medical data that tends to favor PD, why are we not doing more PD?

Recommendations

PERCENTAGE OF PREVALENT PATIENTS ON PERITONEAL DIALYSIS

BY COUNTRY

0

10

20

30

40

50

60

NewZealand

Australia Sweden Norway UnitedStates

Germany Japan Chile

End of year 2000

USRDS 2002 publication

Prevalent patient counts (USRDS),by modality: Dec 31, 2006

December 31 point prevalent patients; peritoneal dialysis counts include CAPD & CCPD only. OPTN was created in 1986.

USRDS 2008; Figure 4.2 (Volume 2)

WHAT WAS RESPONSIBLE FOR THE CHANGE IN TREAND IN PD

GROWTH? Prior to 1995 PD was growing In 1993 to 1996 a change in growth Was it due to:

Medical outcome data? Burden of therapy? Physician knowledge? Expansion in HD capacity? Lack of PD infrastructure? Unintended financial constraints?

WHAT WAS RESPONSIBLE FOR THE CHANGE IN TREAND IN PD

GROWTH? Was it due to:

Medical outcome data? Possibly but not based on recent data

Burden of therapy? Physician knowledge? Expansion in HD capacity? Lack of PD infrastructure? Unintended financial constraints?

CLINICAL PRACTICE ISSUES RELATED TO PD

Patients need to be trained There is a cost associated with training that is not covered

by medicare allowable training fees

There is a high “turn over” rate Transitions are good (HD to transplant) But patient loss may happen before investment (training)

paid back To keep a 100 patient home unit, need to start about 50

patients/year just to stay even

Frequency of testing PET test, 24 hour dialysate and urine collection, etc Not always paid for by CMS

WHAT WAS RESPONSIBLE FOR THE CHANGE IN TREAND IN PD GROWTH?


Was it do to:Was it do to: Medical outcome data?Medical outcome data?

Possibly but not based on recent dataPossibly but not based on recent data Burden of therapy?Burden of therapy?

Possibly, but recent DOQI recommendations make care easierPossibly, but recent DOQI recommendations make care easier Physician knowledge?Physician knowledge? Expansion in HD capacity?Expansion in HD capacity? Lack of PD infrastructure?Lack of PD infrastructure? Unintended financial constraints? Unintended financial constraints?

Fellows’ Perceptions of PD Training (176 Respondents)*

Fellows’ Perceptions of PD Training (176 Respondents)*

0%

20%

40%

60%

80%

A. Fellows are not comfortable initiating PDB. Fellows who feel PD training is inadequateC. Fellows who agree on both (A and/or B)D. Fellows who are less comfortable with PD than HD

A. B. C. D.

* Fellows’ perceptions of adequacy of PD training are not significantly influenced by: years of fellowship, # of years of clinical training during fellowship, future plans, duration of PD clinic, # of acute PD patients, # of PD catheters they placed.

PD TRAINING IN THE U.S.PD TRAINING IN THE U.S.

METHODS:METHODS: Survey of 125 nephrology programs and 742 fellowsSurvey of 125 nephrology programs and 742 fellows Responses in 62 (50%) fellowship directors, 176 (25%) fellowsResponses in 62 (50%) fellowship directors, 176 (25%) fellows

RESULTS:RESULTS: 32% of fellows attend an outpatient PD clinic32% of fellows attend an outpatient PD clinic 52% had a PD rotation < 4 weeks in duration52% had a PD rotation < 4 weeks in duration 53% attended between 0 and 10 ½ day PD clinics53% attended between 0 and 10 ½ day PD clinics 24% of fellows never initiated PD24% of fellows never initiated PD 57% initiated PD on < 5 patients57% initiated PD on < 5 patients 38% felt training was inadequate38% felt training was inadequate

Yadlapalli et al ASN Abstract, JASN 12:2001 A1806Yadlapalli et al ASN Abstract, JASN 12:2001 A1806

PRE TEST RESULTS - PDUsPRE TEST RESULTS - PDUs

METODS:METODS: The ISPD – NAC has conducted about 60 three day courses on PDThe ISPD – NAC has conducted about 60 three day courses on PD Over past 5 years we have had a pre and post testOver past 5 years we have had a pre and post test Used the same 15 (board type) questions which were adjusted over Used the same 15 (board type) questions which were adjusted over

years due to responses/feedbackyears due to responses/feedback

PRE TEST RESULTS:PRE TEST RESULTS: 3 questions > 75% answer correctly3 questions > 75% answer correctly 12 questions <75% answer correctly12 questions <75% answer correctly 7 questions < 50% answer correctly7 questions < 50% answer correctly

PD and ACEDEMICSPD and ACEDEMICS

In medical schools – fellows look up to mentorsIn medical schools – fellows look up to mentors Who are new PD protagonists?Who are new PD protagonists?

NIH is GodNIH is God Very little HIN funding for PDVery little HIN funding for PD

Pharma issuesPharma issues Studies funded by PharmaStudies funded by Pharma FDA rules too restrictiveFDA rules too restrictive

Dialysis a necessary evil – pays the bills, BUTDialysis a necessary evil – pays the bills, BUT Medical schools lost control of units when they were sold to Medical schools lost control of units when they were sold to

chainschains In many cases hard to do research in themIn many cases hard to do research in them

PD EDUCATIONPD EDUCATION

Meetings have historically minimized PD educationMeetings have historically minimized PD education One 30 minute PD talk at this 3 day meetingOne 30 minute PD talk at this 3 day meeting No mention of PD catheter when discussing catheter problems No mention of PD catheter when discussing catheter problems

Academia has failed PDAcademia has failed PD Have not emphasized training, MentorshipHave not emphasized training, Mentorship

NIH funding in PD has been minimalNIH funding in PD has been minimal Hemo trial, FHD trial, ??? PD trialHemo trial, FHD trial, ??? PD trial

FDA restrictions have hindered PDFDA restrictions have hindered PD Very difficult to get new solutions in USVery difficult to get new solutions in US



Was it due to:Was it due to: Medical outcome data?Medical outcome data? Burden of therapy?Burden of therapy? Physician knowledge?Physician knowledge?

Fellows state they feel that their PD training is Fellows state they feel that their PD training is subadequatesubadequate

Expansion in HD capacity?Expansion in HD capacity? Lack of PD infrastructure?Lack of PD infrastructure? Unintended financial constraints? Unintended financial constraints?

US DIALYSIS INDUSTRYUS DIALYSIS INDUSTRY

Since mid 80’s increase in LDOsSince mid 80’s increase in LDOs Huge increase in HD capacityHuge increase in HD capacity Approach to ESRD modality choice Approach to ESRD modality choice

influenced by local/regional/national LDO influenced by local/regional/national LDO “culture”.“culture”.

Marketing wars between LDOsMarketing wars between LDOs For example who has the highest mean Kt/V For example who has the highest mean Kt/V

value? Why??????????????value? Why??????????????

DIALYSIS PROVIDERS% PD Patients

Dialysis Provider # Patients # Units # HD Patients # HHD patients

# PD Patients

% PD Patients

FMC 119,161 1,623 11,942 585 7,634 6.1%

DaVita 107,933 1,374 97,648 1,197 9,088 8.4%

DCI 12,822 204 11,791 68 963 7.5%Renal Advantage 8,307 91 7,545 157 605 7.2%

DSI 7,999 117 7,470 32 497 6.2%American Renal 4,300 72 3,970 10 320 7.4%

Liberty 4,040 74 3,668 52 320 7.9%

Satellite** 3,683 37 2,942 116 625 16.9%

Innovative 2,907 35 2,640 13 254 8.7%

US renal Care 2,904 55 2,645 91 168 5.7%

2008 Totals 274,056 3,682 251,261 2,321 20,474 7.47%

2007 Totals 258,501 3,453 238,873 NA 19,628 7.59%

WFUOPD 1,442 14 1,263 7 185 12.8%

**Many free standing home dialysis only unitsNephrology News and Issues 2008

My Kt/V is Higher Than YoursMy Kt/V is Higher Than Yours

Goal to maximize numbers (which Goal to maximize numbers (which theoretically influence outcomes)theoretically influence outcomes)

Is this realistic?Is this realistic?

COMPARISON OF TOTAL DELIVERED DOSE OF DIALYSIS HD:PD

COMPARISON OF TOTAL DELIVERED DOSE OF DIALYSIS HD:PD

----0.140.140.180.18Weekly KWeekly KRRFRRFt/Vt/V

----2.132.131.621.62Weekly KWeekly KPDPDt/Vt/V

75.2%75.2%66.3%66.3%----% URR % URR

2.262.2611

2.432.4322

1.991.9911

2.162.1622

2.272.271.801.80Total Weekly Total Weekly StdKt/VStdKt/V11

High DoseHigh DoseLow DoseLow DoseHigh DoseHigh DoseLow DoseLow DoseIndexIndex

HEMOHEMOADEMEXADEMEX

1. PD Weekly Kt/V = KPDt/V + KRRFt/V, HD Weekly Kt/V = 3URR

2. Assumes UF = 2L and VPOST = 35L such that VRR=0.057, and Kt/V = 3(URR+0.057)

ADEMEX: SURVIVAL Primary Outcome

ADEMEX: SURVIVAL Primary Outcome

Paniagua, J Am Soc Nephrol, 2002

Various Sub-group analyses also showed no effect of PD clearances on outcomes.

THE HEMO STUDY –Survival by Dose Group

THE HEMO STUDY –Survival by Dose Group

p = NS

Eknoyan et al, NEJM 2002

IT’S THE NUMBERS STUPID!Oh Really?

IT’S THE NUMBERS STUPID!Oh Really?

There are inherent differences in biochemical There are inherent differences in biochemical parameters between PD and CHD patientsparameters between PD and CHD patients

DO these differences in general mean something DO these differences in general mean something in terms of:in terms of:

QOL?QOL? Survival?Survival?

DO these differences in some way subtly DO these differences in some way subtly influence “culture” and “availability” of modality influence “culture” and “availability” of modality in LDOs?in LDOs?

MODALITY EDUCATIONMODALITY EDUCATION

Does it happen?Does it happen? Once when sick?Once when sick? Repeatedly over time?Repeatedly over time?

How is it done?How is it done? BiasedBiased All options given?All options given?



0

50

100

150

200

250

300

350

400

Agreed toRandomization

Wanted HD Wanted PD

Agreed to Randomization Wanted HD Wanted PD

Korevaar JC et al KI 2003; 64:222-228

After 3 ½ years, only 38/735 eligible agreed to randomization!



Was it due to:Was it due to: Medical outcome data?Medical outcome data? Burden of therapy?Burden of therapy? Physician knowledge?Physician knowledge? Expansion in HD capacity?Expansion in HD capacity? Lack of PD infrastructure?Lack of PD infrastructure? Unintended financial constraints? Unintended financial constraints?

PD INFRASTRUCTURE ISSUESPD INFRASTRUCTURE ISSUES

Most PD units in the US have < 10 patientsMost PD units in the US have < 10 patients If this is so, it is hard to justify greater than 2 PD If this is so, it is hard to justify greater than 2 PD

nursesnursesAs a result:As a result:

Hard to grow (remember turnover)Hard to grow (remember turnover) Hard to do a timely start of training (often need to start Hard to do a timely start of training (often need to start

now)now) Hard to do CQIHard to do CQI Hard to problem solveHard to problem solve Outcomes related to experienceOutcomes related to experience

USER-FRIENDLY ENVIRNMENTUSER-FRIENDLY ENVIRNMENT

For MDFor MD Easy to start patientEasy to start patient

CHD vs PDCHD vs PD Easy to manage patientEasy to manage patient

ProtocolsProtocols Nurse dietician driven vs MD intensiveNurse dietician driven vs MD intensive

For PatientFor Patient QOLQOL Easy care availabilityEasy care availability

Adjusted relative risk of death by cumulative number of PD patients treatedAdjusted relative risk of death by cumulative number of PD patients treated

00.10.20.30.40.50.60.70.80.9

1

<100 100- 199 200- 299 300- 399 400- 499 >500

Schaubel KI 2000 60:1517-1524

ANZDATA- infection ratesANZDATA- infection rates

PERITONITIS IN ANZDATAPERITONITIS IN ANZDATA

Peritonitis rates were higher than elsewherePeritonitis rates were higher than elsewhere AustraliaAustralia 1/20.3 pt months1/20.3 pt months New ZealandNew Zealand 1/17.0 pt months1/17.0 pt months CanadaCanada 1/27.6 pt months1/27.6 pt months United StatesUnited States 1/32.7 pt months1/32.7 pt months

Death rates (% of episodes) similarDeath rates (% of episodes) similar Stated 70% of units no infectious prophylaxis Stated 70% of units no infectious prophylaxis (gent, (gent,

mupirocin, anti-fungal) mupirocin, anti-fungal)

May beMay be an explanation for why survival advantage for PD an explanation for why survival advantage for PD in ANZDATA not as robust as in USRDSin ANZDATA not as robust as in USRDS

CONSIDER CONSOLIDATION OF HOME TRAINING UNITSCONSIDER CONSOLIDATION OF HOME TRAINING UNITS

Robust infrastructure important:Robust infrastructure important: Training (quality of and timing of)Training (quality of and timing of) RetrainingRetraining Problem solvingProblem solving Ease of use for patients and MDsEase of use for patients and MDs Peritonitis treatment protocolsPeritonitis treatment protocols Allows for eductionAllows for eduction



Was it due to:Was it due to: Medical outcome data?Medical outcome data?

Possibly but not based on recent dataPossibly but not based on recent data Burden of therapy?Burden of therapy?

Possibly, but recent DOQI recommendations make care easierPossibly, but recent DOQI recommendations make care easier Physician knowledge?Physician knowledge?

Fellows state they feel that their PD training is subadequateFellows state they feel that their PD training is subadequate Expansion in HD capacity?Expansion in HD capacity? Lack of PD infrastructure?Lack of PD infrastructure? Unintended financial constraints?Unintended financial constraints?

Inflation Adjusted Devaluation of U.S. Medicare’s Composite Rate PaymentInflation Adjusted Devaluation of U.S. Medicare’s Composite Rate Payment

$15.34

$143.72

$0

$20

$40

$60

$80

$100

$120

$140

19

74

19

76

19

78

19

80

19

82

19

84

19

86

19

88

19

90

19

92

19

94

19

96

19

98

20

00

20

02

20

04

Co

mp

osi

te R

ates

1974 equivalent Actual CR

1974 dollars adjusted using US Bureau of Labor and Statistics CPI for Medical Care

Composite rates from: Rettig & Levinsky, Kidney Failure and the Federal Government, 1991; current CMS published rate

Composite Rate PaymentEquivalent in 1974 DollarsComposite Rate PaymentEquivalent in 1974 Dollars

$1,311.36

$140.00

$0

$200

$400

$600

$800

$1,000

$1,200

$1,4001

97

0

19

72

19

74

19

76

19

78

19

80

19

82

19

84

19

86

19

88

19

90

19

92

19

94

19

96

19

98

20

00

20

02

20

04

Co

mp

os

ite

Ra

te E

qu

iva

len

t

1974 Dollars

Present Value1974 dollars adjusted using US Bureau of Labor and Statistics CPI for Medical Care

PROVIDERS AND COMPOSITE RATEPROVIDERS AND COMPOSITE RATE

Providers need to be able to make a profitProviders need to be able to make a profit So as composite rate decreasedSo as composite rate decreased

Gauze -- 4x4’s to 2x2’s to 1x1’sGauze -- 4x4’s to 2x2’s to 1x1’s Less RNsLess RNs Decreased staffingDecreased staffing ReuseReuse If you focus only on Kt/V – 2 shifts to 3 shifts to 4 If you focus only on Kt/V – 2 shifts to 3 shifts to 4

shifts a dayshifts a day Look for another source of “margin”Look for another source of “margin”

TOTAL MEDICARE SPENDING ESRD related Injectables

TOTAL MEDICARE SPENDING ESRD related Injectables

Period prevalent dialysis patients.. ESAs: erythropoiesis stimulating agents.

USRDS 2008: Figure 11.15 (Volume 2)

TOTAL MEDICARE EXPENDATURES per person per year, by modality

period prevalent ESRD patients. Modalities determined using Model 2 methodology;

patients with Medicare as secondary payor excluded.

USRDS 2008:Figure 11.8 (Volume 2)

GROWING PAYMENT DISPARITY Yearly Modality Payments (HD vs. PD/patient/yr)

GROWING PAYMENT DISPARITY Yearly Modality Payments (HD vs. PD/patient/yr)

$0

$2,000

$4,000

$6,000

$8,000

$10,000

$12,000

$14,000

$16,000

$18,000

$20,000

1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

U.S

. D

oll

ars

Unadjusted

USRDS Annual Data Report 2007. Data tables k.6 & k.7

$7,216

$18,910

Per person per year access costs, by access typePer person per year access costs, by access type

dialysis patients from the 1999–2006, ESRD CPM data with Medicare as primary payor & vascular access data. Intent-to-treat model. Vascular access type in use in December prior to cost years 1999–2006. Costs include “pure” inpatient & outpatient claims & physician/ supplier access costs.

USRDS 2008: Figure 11.23 (Volume 2)

CMS ESRD COSTSCMS ESRD COSTS

About 6% of total Budget, < 1% of recipientsAbout 6% of total Budget, < 1% of recipients Total amount increasing exponentiallyTotal amount increasing exponentially PD costs system less than HDPD costs system less than HD

But, each of us have our hands in different cookie jarsBut, each of us have our hands in different cookie jars Medicare parts A, B, DMedicare parts A, B, D

Perverse unintended incentives exist:Perverse unintended incentives exist: Some might be to stimulate home useSome might be to stimulate home use Others might favor center HD useOthers might favor center HD use Providers may be influenced by margin potentialProviders may be influenced by margin potential

Dialysis Services HCPCS Code

2005 2006 2007 2008

In- Center Dialysis

1 Visit G0319 $207 $207 $186 $175 2-3 Visits G0318 $260 $259 $236 $225

4 Visits G0317 $312 $311 $287 $274Home Dialysis

Full Month G0323 $260 $259 $230 $214

•Calculated From:http://www.cms.hhs.gov/PhysicianFeeSched/01_Overview.asp•Courtesy of Gary Inglese

2008 Monthly Capitated Payment

The Medicare Modernization Act (MMA) The Medicare Modernization Act (MMA)

It was far more than a Prescription Drug Bill.It was far more than a Prescription Drug Bill. It greatly affects the payments to providers It greatly affects the payments to providers

(hospitals, clinics, dialysis units) for injectable (hospitals, clinics, dialysis units) for injectable medicationsmedications

Markedly reduces the “profits” or “margins” from Markedly reduces the “profits” or “margins” from puchasing a unit of medicationpuchasing a unit of medication

As the composite rate moves towards more bundling, As the composite rate moves towards more bundling, drugs will be brought into itdrugs will be brought into it

BundlingBundling

One payment for numerous services grouped One payment for numerous services grouped togethertogether

Injectables + dialysis labor and equipment vs. Injectables + dialysis labor and equipment vs. injectables separateinjectables separate

This can get far more complicatedThis can get far more complicated Monthly, weekly, per treatment schedule?Monthly, weekly, per treatment schedule?

LDOs and Feds want itLDOs and Feds want it Physicians are +/- because it could include their Physicians are +/- because it could include their

fees eventuallyfees eventually


Outcomes for PD are improvingOutcomes for PD are improving How can we make them even betterHow can we make them even better RecommendationsRecommendations

RECOMMENDATIONSRECOMMENDATIONS

Consider consolidation of Home unitsConsider consolidation of Home units Academia needs to be more involved in PDAcademia needs to be more involved in PD FDA needs to reconsider general guidelines for FDA needs to reconsider general guidelines for

approvalapproval We need to listen to patientsWe need to listen to patients Should not just think PD VERSUS HD, rather lets Should not just think PD VERSUS HD, rather lets

leverage both modalities as clinically appropriate leverage both modalities as clinically appropriate for the patientfor the patient

In fact at times, WHY NOT USE BOTH In fact at times, WHY NOT USE BOTH simultaneously in a patient?simultaneously in a patient?

GO TO:ISPD.org

August 27-19, 2009

QUESTIONS?

OPTIMIZING OUTCOMES ON PERITONEAL DIALYSIS: John Burkart, M.D. Wake Forest University Baptist Medical Center Winston Salem, NC USA 07/12/2008.

Documents

pd survival

pd unit

explanation of pd

pd patientsfollow

home dialysis pd

hd baseline742947 hd

relative risk of hd

acknowledgedcomparison