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OPTIMIZING OUTCOMES ON PERITONEAL DIALYSIS:

OPTIMIZING OUTCOMES ON PERITONEAL DIALYSIS:. John Burkart, M.D. Wake Forest University Baptist Medical Center Winston Salem, NC USA 07/12/2008. Advisory Boards --- Grants ---------------- Honoraria ----------- Chief Medical Officer. Baxter, NxStage, Genzyme, CMS

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OPTIMIZING OUTCOMES ON PERITONEAL DIALYSIS:

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

  2. Advisory Boards --- Grants ---------------- Honoraria ----------- Chief Medical Officer Baxter, NxStage, Genzyme, CMS NIH, Baxter, Genzyme, Abbott, NxStage, Watson Baxter, Fresenius 14 dialysis units (CHD, PD, HHD) CONFLICT OF INTERESTJohn Burkart

  3. CONFLICT OF INTEREST • Passion for home dialysis (PD and HHD) • Course director PDUs • Involved in Frequent HD study (nocturnal) • Medical director 14 units (until 2008 CFC) • In the Wake Forest Outpatient Units about 13% of patients on Home dialysis • About 30% of my patients on Home Dialysis

  4. 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

  5. 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

  6. Attempted to randomize patients to PD or HD • Eligible patients were given extensive informed consent • Informed consent included explanation of PD and HD

  7. PATIENT MODALITY CHOICE:Lessons from an Attempted Prospective Randomized Trial After 3 ½ years, only 38/735 eligible agreed to randomization! Korevaar JC et al KI 2003; 64:222-228

  8. ATTEMPTED PRCT TO EVALUATE SURVIVAL ON PD vs. HD • 773 eligible patients • Only 38 were randomized • Results underpowered • Survival better on PD Korevaar JC et al KI 2003; 64:222-228

  9. WHAT DO OBSERVATIONAL COHORT STUDIES SHOW US? Caveats, limitations thereof acknowledged

  10. COMPARISON OF HD AND PD SURVIVAL IN THE NETHERLANDS Methods: • 20,687 patients started RRT between 1/1/87 and 12/31/02 • Excluded data on: Transplant first 90 days; HD unit < 20 pts or PD unit < 5 pts; < 18 years old • Final analysis – 47 centers; 16,643 total: 10,841 on HD, 5802 on PD. • Analysis univariate and multivariate Cox model Liem et al, KI 2007; 71:153-158

  11. UNAJUSTED PATIENT SURVIVALPD vs HD - Netherlands Liem et al, KI 71:153-158, 2007

  12. 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; 14:2851-2860

  13. RELATIVE RISK OF DEATHHD vs PD Termorshuizen et al. JASN 14: 2851-2860; 2003

  14. 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

  15. 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

  16. 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

  17. ADJUSTED FIVE YEAR SURVIVALby 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

  18. 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

  19. ADJUSTED FIVE-YEAR SURVIVAL:by first modalityUSRDS 2007Figure p.25 Point where relative risk crosses has moved to right! 91-95 96-00 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.

  20. RELATIVE RISK OF DEATH:PD vs HD --ANZDATA MacDonald et al. JASN 20:155-163; 2009

  21. ANZDATA REGISRTYRelative Risk of Death PD vs HD MacDonald et al. JASN 20:155-163; 2009

  22. PERITONITIS RATES ARE HIGH IN ANZDATA Johnson AJKD 2009: 53:290-297

  23. 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 trends These are Observational cohort studies • These studies have limitations do not establish casuality and are hypothesis generating

  24. 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

  25. 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

  26. 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.

  27. INFECTION RELATED PATIENT TRANSFER FROM PD to HD DECREASING Guo, Mujais. Kidney Int. 2003;64 (suppl 88):S1-S10.

  28. TOPICAL MUPIROCIN REDUCES ESI/PERITONITIS P=0.003 P<0.001 P=0.19 Casey, Burkart PDI 2000

  29. Mupirocin prophylaxis reduces S aureus peritonitis S aureus peritonitis/year The Mupirocin Study Group Thodis Perez-Fontan Bernardini

  30. Double Blinded Randomized Trial of Mupirocin vs Gentamicin Exit Site Cream Gentamicin cream reduced GNR peritonitis, compared to mupirocin PERITONITIS Piraino, Bernardinin - Presented at ISPD 2004 Congress

  31. PERITONITIS USUALLY RESOLVES WITHOUT COMPLICATIONS % all episodes Bunke et al V52;2 p524 KI 1997

  32. Infection Rates Reduced In PDAs Innovations and Protocols Are Introduced 1.1 1.0 Y set introduce d 0.9 Double bag system 0.8 prophylaxes S aureus introduced 0.7 0.6 Spike assist device for cycler patients 0.5 0.4 0.3 0.2 0.1 0 83 85 87 89 91 93 95 97 99 01 03 05 Peritonitis Episodes/Patient Year Peritonitis Episodes per Dialysis Year Bender FH et al. KI, 2006;70(S):S44-S54.

  33. WHAT ACCESS DO YOU HAVE IN YOUR UNIT? Prevalent vs. Incident

  34. PD - peritonitis Bacteremia WFOPD data 2004-2005

  35. ADJUSTED MORTALITY AFTER FIRST SEPTICEMIC EVENT USRDS: 2003 ADR 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.

  36. INFECTION RATES PD vs HD • Remember 82% of all new CHD patients start with a catheter! (USRDS 2008 report) • Infection rates higher with Tunneled vascular catheters than with PD (peritonitis) • Bacteremia with Tunneled catheters have been increasing! • Bacteremia associated with increased RRD for 2 to 3 years • Up to 30% of patients with catheters have 1 episode of bacteremia by 6 months! • Peritonitis almost never associated with bacteremia.

  37. - One Size Does Not Fit All! - Must Have Flexibility in Exit-Site Placement • Presternal • Upper Abdominal • Mid-abdominal • Lower Abdominal

  38. 99.5% 100 87.2% 82.5% 75 50 % Probability 25 0 Open Basic Advanced Dissection Laparoscopy Laparoscopy PD CATHETERS HAVE A HIGH SUCCESS RATE! Probability of Remaining Free of Mechanical Flow Obstruction At 24 Months Significantly Increased by Newer Techniques P < 0.0001 vs open or basic technique Crabtree JH et al. Am Surg. 2005;71:135-143.

  39. Cumulative probability of multiple catheter placementsFigure 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.

  40. 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

  41. 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 free 7.8+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

  42. 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

  43. 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

  44. PERCENTAGE OF PREVALENT PATIENTS ON PERITONEAL DIALYSIS BY COUNTRY End of year 2000 USRDS 2002 publication

  45. 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)

  46. 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?

  47. 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?

  48. 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

  49. WHAT WAS RESPONSIBLE FOR THE CHANGE IN TREAND IN PD GROWTH? • Was it do to: • Medical outcome data? • Possibly but not based on recent data • Burden of therapy? • Possibly, but recent DOQI recommendations make care easier • Physician knowledge? • Expansion in HD capacity? • Lack of PD infrastructure? • Unintended financial constraints?

  50. Fellows’ Perceptions of PD Training(176 Respondents)* A. B. C. D. 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 * 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.

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