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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
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
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
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?
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
WHAT WAS RESPONSIBLE FOR THE CHANGE IN TREAND IN PD GROWTH?
WHAT WAS RESPONSIBLE FOR THE CHANGE IN TREAND IN PD GROWTH?
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?
PATIENT MODALITY CHOICE:Lessons from an Attempted Prospective Randomized Trial
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!
WHAT WAS RESPONSIBLE FOR THE CHANGE IN TREAND IN PD GROWTH?
WHAT WAS RESPONSIBLE FOR THE CHANGE IN TREAND IN PD GROWTH?
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
WHAT WAS RESPONSIBLE FOR THE CHANGE IN TREAND IN PD GROWTH?
WHAT WAS RESPONSIBLE FOR THE CHANGE IN TREAND IN PD GROWTH?
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
TOPICS TO BE COVEREDTOPICS TO BE COVERED
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?