Experts in all modalities The Expanding Role of PD Trends and Advances That Have Increased the Viability and Utilization of Peritoneal Dialysis

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1 Experts in all modalities The Expanding Role of PD Trends and Advances That Have Increased the Viability and Utilization of Peritoneal Dialysis Todd W.B. Gehr, M.D. Professor and Chairman, Division of Nephrology Virginia Commonwealth University, Richmond

2 Experts in all Modalities CASE: 18 month old male with HUS develops ESRD CAPD for 12 months: complicated by hernia Living related transplant age 3 Recurrent HUS, back on CCPD after hernia repair by age 4 Ultrafiltration failure, age 7, switched to HD Incenter HD, severe HTN, bilateral nephrectomy age 7 Home HD age 8 via permacath

3 Experts in all Modalities CASE: continued Home HD for 5 years via permacath Age 13, Cadaveric Renal transplant Recurrent HUS, failed transplant age 14 Home HD via combined AVG-AVF age 14 Age 16, button hole technique, sticks himself Age 18, Graduated from High School, 2004 Age 21, Graduated from college, Computer technology Age 21, engaged to be married Age 23, 3 rd transplant on eculizamab and doing fine at one yr

4 Number of Patients (in thousands) Rate per Million Population The Increasing Problem of ESRD ESRD 6x More Prevalent Than in Counts ,000 Rates ,000 4,000 3, All 2, , Year Year Point Prevalent Patients, Adjusted For Gender & Race U.S. Renal Data System. USRDS 2006 Annual Data Report. Chapter 1, National Institutes of Health. Bethesda, MD

5 Total Expenditures ($, in billions) ESRD Now Costs Medicare $18.5 Billion/Yr $16.3 Billion Of This For Dialysis Graft failure within year Functioning graft only T ransplant event within year Dialysis only Year Paid Claims From First ESRD Service Until Death Or End Of Study U.S. Renal Data System. USRDS 2006 Annual Data Report. Chapter 11, National Institutes of Health. Bethesda, MD

6 Total Costs ($, in millions) Increase in Dialysis Expenditures Driven By HD Hemodialysis Peritoneal dialysis Year Medicare ESRD Part B Vascular Access Claims U.S. Renal Data System. USRDS 2006 Annual Data Report. Chapter 11, National Institutes of Health. Bethesda, MD

7 Cumulative Probability of Changing Status* PD / HD Survival Comparable 0.8 Diabetic HD Death 0.8 Non-diabetic 0.6 PD Death Months After Initiation Probability of Death, PD and HD *Changing status: modality switch or death U.S. Renal Data System. USRDS 2006 Annual Data Report. Chapter 4, National Institutes of Health. Bethesda, MD

8 % Increase in Survival PD Survival Has Increased Substantially Increase in 5-year Relative Probability of Survival From to % % 5 0 PD HD Among Incident ESRD Patients Adjusted For Age, Gender, Race, And Primary Diagnosis U.S. Renal Data System. USRDS 2006 Annual Data Report. Chapter 6, National Institutes of Health. Bethesda, MD

9 Number of Patients (in thousands) Yet PD Utilization Remains Flat Incident ESRD Patients By First Modality Hemodialysis (2004: 94,891) Peritoneal dialysis (6,686) T otal dialysis (102,104) T ransplant (2,260) Year U.S. Renal Data System. USRDS 2006 Annual Data Report. Chapter 4, National Institutes of Health. Bethesda, MD

10 % Prevalent Patients on PD Prevalent Patients on PD % 25.6% 24.7% % 7.7% 0 New Zealand Netherlands Denmark Canada United States U.S. Renal Data System. USRDS 2006 Annual Data Report. Chapter 12, National Institutes of Health. Bethesda, MD

11 PD Plays An Important Role in RRT Hemodialysis Home HD Peritoneal Dialysis Transition Points Transplant CKD ESRD: Initial Continuing Care Late MD Nurse Educator Renal Dietitian Social Worker Monthly Visit Acute Visits Post Hospitalization Acute Transition Points Death/ Treatment Withdrawal

12 Creatinine Clearance (ml/min) Integrated ESRD Care Positioning of PD as First Choice Peritoneal Dialysis PD Transplant HD 5 0 Initiation of Dialysis Time on Dialysis

13 So Why Is PD Underutilized? Despite Improved Survival and Economic Benefits Not offered to patients 1-3 Lack of pre-esrd education 2 Physician bias 4 - Limited training - Limited knowledge - Limited experience Reimbursement issues 2-4 Late referral to nephrologist 2 Social/cultural factors 1,3,4 1. Mehrotra R et al. Kidney Int. 2005;68: Lameire N et al. Blood Purif. 2006;24: Wuerth DB et al. Perit Dial Int. 2002;22: Venkataraman V et al. Perit Dial Int. 1999;19(suppl):S419-S422.

14 Question: Did you see more than 10 PD patients in your fellowship training? In a recent program, 25% of second-year nephrology fellows reported no exposure to PD whatsoever. Nissenson AR et al. Semin Dial. 2004;17:

15 What Limits Nephrologists Use of PD? Are These Concerns Still Valid? Technique Failure Long-term Viability Mortality Rates 12 Peritonitis Rates Facility Limitations Catheter Problems Limited Nursing Staff Limited Training %: Did this limit your use of PD? Troidle L et al. Perit Dial Int. 2006;26:

16 Why the Role of PD Should Expand Improved survival, particularly for specific populations Patient preference Decreasing incidence of complications Substantial economic advantage

17 Relative Risk (RR) Improved Survival in PD Without Diabetes, and < Age Relative Risk, PD:HD (As Treated) 1.2 HD Better PD Better No Diabetes Diabetes Male < age 55 Male age 55 Female < age 55 Female age ,158 Medicare Patients, 1994 Through 1996 Collins AJ et al. Am J Kidney Dis.1999;34:

18 Improved Survival in PD Younger Patients, or Without Diabetes or Comorbidity Relative Risk (RR) Age Age Age >65 Average Age Age Age >65 Average Age Age Age >65 Average Age Age Age >65 Average HD Better No Diabetes Diabetes Age, Comorbidity, and RR of Death (PD:HD) PD Better (-) Comorbidity (+) Comorbidity (-) Comorbidity (+) Comorbidity Vonesh EF et al. Kidney Int. 2006;70(suppl):S3-S11.

19 Patient Survival PD/HD Survival Virtually Identical In Overall Population of 398,940 Patients At 3 Years, 1 Month Difference In Adjusted Median Life Expectancy 1.0 RR for PD:HD = HD PD Months of Follow-Up Vonesh EF et al. Kidney Int. 2006;70(suppl):S3-S11.

20 Relative Risk, HD:PD Early Survival Advantage in PD In 398,940 ESRD Patients 4.0 Cause of ESRD = Non-DM Age Cause of ESRD = Non-DM Age Cause of ESRD = Non-DM Age Cause of ESRD = DM Age Cause of ESRD = DM Age Cause of ESRD = DM Age Months of Follow-Up Vonesh EF et al. Kidney Int. 2004;66:

21 The CHOICE Study Choices for Healthy Outcomes in Caring for ESRD Relative Risk Of Death (PD:HD) Year (95% CI, 0.64 to 3.06) Year (95% CI, 1.19 to 4.59) Adjusted for Demographic Characteristics, Clinical and Treatment Factors, and Laboratory Values Jaar BG et al. Ann Intern Med. 2005;143:

22 The CHOICE Study Choices for Healthy Outcomes in Caring for ESRD A prospective, nonrandomized trial 1041 patients starting dialysis (274 PD, 767 HD) Followed for up to 7 years RR of death for PD vs. HD was calculated by Cox proportional hazards regression, stratified by clinic Jaar BG et al. Ann Intern Med. 2005;143:

23 Limitations of CHOICE 1. Small sample size (N=247 on PD) 2. 90% received care from one provider 3. Statistical adjustments resulting in dramatic change in outcomes 4. Baseline dose known for only 26.3% of PD patients; no further monitoring described 5. RRF not specified except at baseline 6. Peritoneal solute transport characteristics of PD group not described Schulman G. Ann Intern Med. 2005;143:

24 Sample Sizes: CHOICE vs. Vonesh CHOICE: Choices for Healthy Outcomes in Caring for ESRD Average RRs of Death from CHOICE 1 and U.S. Medicare Data 2 Patient group CHOICE 1 U.S. Medicare 2 N RR (PD:HD) N RR (PD:HD) All patients a , All patients b * 398, * No Diabetes * 220, * Diabetes , * Age < 65 years * 196, Age 65 years , * a Adjusted for demographic and clinical (including comorbidity) characteristics alone b Adjusted for demographic, clinical (including comorbidity) and laboratory characteristics *P < 0.05 compared to RR = Jaar BG et al. Ann Intern Med. 2005;143: Vonesh EF et al. Kidney Int. 2006;70(suppl):S3-S11.

25 Most Patients Are Eligible for PD >1000 ESRD Patients Starting Dialysis % Medically Eligible for PD Netherlands 1 83% U.S. 2 76% The prevalence of medical contraindications to PD (23% to 24%) is similar to the 17% to 21% reported from other parts of the world Jager K et al. Am J Kidney Dis. 2004;43: Mehrotra et al. Kidney Int. 2005;68:

26 Most Patients Will Have Comparable or Better Survival with PD PD better than HD: 30% Nondiabetics with no comorbidities Younger diabetics with no comorbidities 30% 30% PD = HD: 30% Nondiabetics with one comorbidity Younger diabetics with one comorbidity 40% PD worse than HD: 40% Older diabetics, with or without comorbidities Vonesh EF et al. Kidney Int. 2004;66:

27 Nephrologists Surveyed Say: More Patients Should Be on PD Country Year % of ESRD patients nephrologists feel should be on PD USA % 59 USA % 240 Canada % 192 British Isles % 108 N 1. Troidle L et al. Perit Dial Int. 2006;26: Mendelssohn DC et al. Am J Kidney Dis. 2001;37: Jung B et al. Perit Dial Int. 1999;19: Jassal SV et al. Nephrol Dial Transplant. 2002;17:

28 Why the Role of PD Should Expand Improved survival, particularly for specific populations Patient preference Decreasing incidence of complications Substantial economic advantage

29 Many Patients Would Prefer PD Independence: Home based Flexible schedule Ease of travel / recreation / work Active role in own health care And: Overall convenience / ease Fewer injections / fear of needles

30 The More Patients Know, The More They Choose PD Percentage of Patients After Pre-ESRD Education, 45% Chose PD and 33% Actually Started PD N = 2400 PD HD Choice of Modality Actual Modality Started US Incidence The National Pre-ESRD Education Initiative Survey Golper T. Nephrol Dial Transplant. 2001;16(suppl):20-24.

31 Regardless of the medical advantages of PD or HD, the experience with pre-esrd education has shown that wellinformed patients exert their right to choose more often. Diaz-Buxo JA. Perit Dial Int. 1998;18:

32 Outcomes Better When Patients Choose Regardless of Modality Chosen RR of Death Association of Patient Autonomy with Increased Transplantation and Survival Among New Dialysis Patients in the United States Physician Chose Patient Chose N = PD HD Survival Greater in Patients Who Chose (49.7% vs. 34.9%) Stack AG et al. Am J Kidney Dis. 2005;45:

33 PD Patients Rate Their Therapy As Excellent % of Excellent Ratings * 82 PD *P < 0.05 vs. HD patients 56 HD PD HD Adjusted For Age, Sex, Race, Education, Marital Status, Employment Status, Comorbid Conditions, Distance From Center, And Time On Dialysis Rubin HR et al. JAMA. 2004;291:

34 PD Patients Rate Their Nephrologist As Excellent % of Excellent Ratings 100 PD Adjusted HD *P < 0.05 vs HD patients * * * * Caring and Concern Ease of Reaching Frequency of Seeing Coordination With Other Physicians Adjusted For Age, Sex, Race, Education, Marital Status, Employment Status, Comorbid Conditions, Distance From Center, And Time On Dialysis Rubin HR et al. JAMA. 2004;291:

35 PD Advantages Important For Elderly Increased cardiovascular stability (fewer arrhythmias) Decreased travel requirements Marked decrease in needle sticks Low risk of GI bleeding Low risk of bacteremia Even Patients Not Normally Considered for PD Might Have Reasons to Choose This Modality Teitelbaum I. Contrib Nephrol. 2006;150:

36 PD and the Quality of Remaining Years Finally, it must be recognized that longevity is neither the only, nor necessarily the most important, clinical endpoint. For many patients, particularly the elderly, quality of life is at least as important, if not more so, than quantity. Teitelbaum I. Contrib Nephrol. 2006;150:

37 Why the Role of PD Should Expand Improved survival, particularly for specific populations Patient preference Decreasing incidence of complications Substantial economic advantage

38 Peritonitis Is the Most Common Infection with PD The Achilles heel of PD A major cause of morbidity and mortality The leading cause of technique failure in PD Troidle L et al. Ann Clin Microbiol Antimicrob. 2006;5:6.

39 Percent of All Episodes Peritonitis Usually Resolves Without Complications Percent (%) of All Episodes (N = 666) Resolved Hospital Catheter Removed CoagNS S aureus np-gnr Transfer Death CoagNS=coagulase-negative staphylococci; np-gnr=non-pseudomonal gram negative Bunke CM et al. Kidney Int. 1997;52:

40 Hospital Admissions for PD-Related Peritonitis Decreasing Admissions per 1000 Patient Years Admissions for Dialysis-related Infection Peritoneal dialysis: peritonitis 100 Hemodialysis: vascular access infection Year U.S. Renal Data System. USRDS 2006 Annual Data Report. Chapter 6, National Institutes of Health. Bethesda, MD

41 Peritonitis Episodes/Patient Year Infection Rates Reduced In PD As Innovations and Protocols Are Introduced Y set introduce d Double bag system S aureus prophylaxes introduced Spike assist device for cycler patients Peritonitis Episodes per Dialysis Year Bender FH et al. Kidney Int, 2006;70(suppl):S44-S54.

42 Approaches to Reduce Exit-Site Infections Mupirocin Prophylaxis Reduction in Relative Risk of Exit-Site Infection* Reduced S. aureus Infection in PD Perez 1993 Mupirocin Study Group Thodis Thodis Crabtree 2000 Overall 0 25% 10% 50% 75% 67% 68% 60% 62% 100% 86% *Risk of exit-site infection, mupirocin : without mupirocin. P < vs placebo or no treatment. Tacconelli E et al. Clin Infect Dis. 2003;37:

43 Approaches to Reduce Exit-Site Infections Gentamicin Prophylaxis Exit Site Infections per Patient-Year Reduced Gram-negative Infections in PD mupirocin gentamicin * * 0 Incident Patients Prevalent Patients Rates of Exit-Site Infections *P < 0.01 vs mupirocin Bernardini J et al. J Am Soc Nephrol. 2005;16:

44 Rate per Patient Year Rate per Patient Year Low Rate of Sepsis with PD Catheter Complications, 1 st Year Dialysis PD HD Infection Peritonitis Sepsis 0.5 Infection Sepsis Incident Patients, CPM Database U.S. Renal Data System. USRDS 2006 Annual Data Report. Chapter 5, National Institutes of Health. Bethesda, MD

45 Consequences of access-related infection

46 Complications of Access-related Infection

47 Bacteremia Is the Most Common Infection with HD Number of Cases Septicemia in HD is Increasingly Due to Resistant Organisms 10 8 Non-MSRA MSRA Y ears Including methicillin-resistant S. aureus (MRSA) 1 vancomycin- and linezolid- resistant S. aureus, 2 and an epidemic, toxin gene-variant strain of Clostridium difficile 3 1. Chang CF et al. J Nephrol. 2004;17: Tacconelli E et al. Clin Infect Dis. 2003;37: McDonald LC et al. N Engl J Med. 2005;353:

48 Hospitalization for Pneumonia Relatively Low with PD Admissions per 1,000 Patient Years Hospitalizations for Pneumonia in Period-Prevalent ESRD Patients 100 Hemodialysis Peritoneal dialysis Transplant Year U.S. Renal Data System. USRDS 2006 Annual Data Report. Chapter 6, National Institutes of Health. Bethesda, MD

49 Rate per Patient Year Rate per Patient Year Few Catheter Events With PD 1 st Year Dialysis, Incident Patients PD HD Removal Removal 1.5 Replace with PD catheter Replace with HD catheter 1.5 Replace with catheter Replace with internal device 1.0 Replace with internal HD access U.S. Renal Data System. USRDS 2006 Annual Data Report. Chapter 5, National Institutes of Health. Bethesda, MD

50 % Probability High Catheter Survival In PD Probability of Remaining Free of Mechanical Flow Obstruction At 24 Months Significantly Increased by Newer Techniques P < vs open or basic technique % 87.2% 99.5% Open Dissection Basic Laparoscopy Advanced Laparoscopy Crabtree JH et al. Am Surg. 2005;71:

51 PD HD Dropouts In Decline Reasons for Dropout In >40,000 PD Patients Other Medical Reasons 22% Decreasing Infection 28% Psychosocial 15% Inadequate Dialysis 18% Catheter Problems 17% Decreasing Mujais S et al. Kidney Int. 2006;70(suppl):S21-S26.

52 Percent of Patients PD Success Improving 5% Per Year Fewer Patients Transferring To HD In First Year 100 Dropouts to HD 21 5% relative decline 20 5% relative decline N = 11,137 N = 10,658 N = 10,340 Study Cohorts Guo A et al. Kidney Int. 2003;64(suppl):S3-S12.

53 Why the Role of PD Should Expand Improved survival, particularly for specific populations Patient preference Decreasing incidence of complications Substantial economic advantage

54 Medicare Costs for ESRD Relatively Constant for PD U.S. Dollars ($) 80,000 70,000 Cost per Patient per Year 60,000 50,000 40,000 30,000 20,000 10,000 0 Hemodialysis Peritoneal Dialysis U.S. Renal Data System. USRDS 2006 Annual Data Report. vol 2: Reference Tables.Section K, National Institutes of Health. Bethesda, MD

55 U.S. Dollars ($) Economic Benefit of PD Increasing Due to Rising Costs of HD Difference in Cost per Patient per Year 20,000 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 U.S. Renal Data System. USRDS 2006 Annual Data Report. vol 2: Reference Tables. Section K, National Institutes of Health. Bethesda, MD

56 Medicare Spending ($, in billions) Increased Cost of Injectables Total Medicare Spending on Injectables 3 2 Other injectables IV iron IV V itamin D hormone ESAs Year ESA = erythropoiesis stimulating agent Medicare Cost of Erythropoietin Up 17% From 2003 to 2004 Alone U.S. Renal Data System. USRDS 2006 Annual Data Report. Chapter 11, National Institutes of Health. Bethesda, MD

57 Expenditure (adjusted to 2004 dollars) Even with Switching, PD Saves Annual Medicare Expenditure for Dialysis With or Without Switching Modalities 80,000 70,000 60,000 50,000 40,000 30,000 20,000 10,000 0 * 44,111 72,185 72,335 66,639 PD, no switch HD, no switch PD, 1 switch HD, 1 switch N=3,423 *P < vs HD Shih YC et al. Kidney Int. 2005;68:

58 Expenditure (adjusted to 2004 dollars) Effect of Switch Timing on 3-Year Costs Cost of 3 Years of Dialysis 300,000 * $268,280 *P < vs HD 250, ,000 * $178, , ,000 * $115,237 50,000 0 Start PD, switch year 1 Start PD, switch year 2 Start PD, switch year 3 Start PD, Switch Year Three, Saves $108,433 (48.5%) N=3,180 Shih YC et al. Kidney Int. 2005;68:

59 PD Is Not Just a Viable RRT Option PD Is a Vital Element of Care for the Patient with CKD Hemodialysis Peritoneal Dialysis Transition Points Home HD Transplant CKD ESRD: Initial Continuing Care Late MD Nurse Educator Renal Dietitian Social Worker Monthly Visit Acute Visits Post Hospitalization Acute Transition Points Death/ Treatment Withdrawal

60 For many patients, PD is preferable in early treatment, given the better quality of life, the better psychosocial adaptation, the higher levels of subjective wellbeing, the sparing of vascular access, and the better preservation of RRF. Shahab I et al. Adv Perit Dial. 2006;22:

61 Are These Concerns Still Valid? What Limits Nephrologists Use of PD? Technique Failure Long-term Viability Mortality Rates 12 Peritonitis Rates Facility Limitations Catheter Problems Limited Nursing Staff Limited Training %: Did this limit your use of PD? Troidle L et al. Perit Dial Int. 2006;26:

62 Why the Role of PD Should Expand Improved survival, particularly for specific populations Patient preference Decreasing incidence of complications Substantial economic advantage AL /07

63 Home Penetration Rates FMS 178,337 DaVita 174,300 DCI 14,800 ARA 12,250 DSI Renal 7,436 Satellite 6,541 Renal Ventures 2,387 Atlantic Dialysis 2, Home Penetration Rate US Renal 16, % 9.8% 9.2% 12.4% 11.0% 12.2% 11.1% 20.9% 14.7% Home Penetration Rate: Fresenius vs. DaVita Source: Project Home First: NO Limits

64 Admission & Attrition FMS admitted ~10,600 home patients in 2014, and discharged ~9,300 patients. A significant percentage of the attrition is preventable. ~10,600 home admissions in 2014 Home Therapy ~16,000 Patients 12/31/2014 ~9,300 home attrition in 2014 Project Home First: NO Limits

65 A Deeper Dive into PD Attrition 2014 PD Attrition Starting Patients 12,858 patients Patients Admitted + 9,037 (70% of patients) Patients Discharged - 8,045 (63% of patients) Ending Patients 13,796 patients Reasons for Transfer In Center 2014 PD Discharges Total Discharges 8,045 Deaths/Discontinued -1,473 Transplants ,679 Transferred to non FMS Home ,351 Transferred in center FMS 3,704 Project Home First: NO Limits