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Daily and Nocturnal Hemodialysis

Daily and Nocturnal Hemodialysis. Alan S. Kliger MD Hospital of St. Raphael Yale University School of Medicine New Haven CT. Best Opportunities to Improve Outcomes. Increase Dialysis Dose Reduce Inflammation Decrease LVH Restore fluid balance and BP Reduce Sympathetic Activity

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Daily and Nocturnal Hemodialysis

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  1. Daily and Nocturnal Hemodialysis Alan S. Kliger MD Hospital of St. Raphael Yale University School of Medicine New Haven CT

  2. Best Opportunities to Improve Outcomes Increase Dialysis Dose Reduce Inflammation Decrease LVH Restore fluid balance and BP Reduce Sympathetic Activity Reduce Depression

  3. Cardiovascular disease mortalitygeneral population vs ESRD patients 100 10 GP Male 1 GP Female GP Black 0.1 GP White Dialysis Male 0.01 0.001 25-34 35-44 45-54 55-64 66-74 75-84 >85 Annual CVD Mortality (%) Dialysis Female Dialysis Black Dialysis White Age (years) Foley RN, et al. Am J Kidney Dis. 1998;32:S112-S119. GP = General Population.

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  6. HEMO Study: Survival by dose group 1,846 Patients Eknoyan et al, N Eng J Med 2002

  7. BREAST CANCER HIV PROSTATE CANCER THE DEATH-RATE WAS THREE TIMES THAT OF BREAST CANCER AND HIV, TWICE THAT OF PROSTATE CANCER Slide courtesy of Dr. Kjellstrand HEMO

  8. Mean = 2.19 Mean = 2.53 2.88 2.59 Weekly Std Kt/V 2.30 2.02 Standard Dose High Dose Post-Hoc Analysis of HEMO Study Limited separation between treatment groups for unified dose measures, such as Standard Kt/V ≅ [urea generation rate] / [average (C0)] Separation in Std Kt/V in HEMO Trial Only 16% difference in mean Std Kt/V between dose groups

  9. Effect of increasing length of dialysis Three sessions per week 7 6 5 HEMO: High 4 Weekly Dialysis Dose (stdKt/V) 3 2 1 HEMO: Standard 0 0.0 0.5 1.0 1.5 Dialysis dose each dialysis (eKT/V)

  10. Effect of increasing number of dialysis sessions per week 7 Hemodialysis Daily Dialysis 6 sessions/wk 6 5 HEMO: High 4 Weekly Dialysis Dose (stdKt/V) 3 3 2 1 HEMO: Standard 0 0.0 0.5 1.0 1.5 Dialysis dose each dialysis (eKT/V)

  11. Daily HD – Summary of Findings 12 Suri R. et al. CJASN 1:33-42, 2006

  12. Retrospective Analysis of Survival for 415 Patients Treated with Short Daily Hemodialysis • 10 year survival: 42+9% • Compared with matched patients from USRDS: • Daily dialysis patient survival was 2-3 times higher • Predicted survival times were 2.3 -10.9 yrs longer for daily dialysis patients Kjellstrand et al NDT 23:3283, 2008

  13. C U M S U R V I V A L SHORT DAILY HOME HD N=265 USRDS CAD TX 2005 USRDS PD AND HD SURVIVAL Slide courtesy of Dr. Kjellstrand

  14. Nocturnal HD – Summary of Findings Walsh M et al. Kidney Int 67:1500-1508, 2005 15 Walsh M et al Kidney Int 67: 1500-1508, 2006

  15. Alberta RCT Nocturnal HD vs Conventional HD Primary Outcome: Change in LV mass 52 patients randomized 44 had baseline MRI 35 had follow-up MRI after 6 months No second MRI 6 refused 2 transplanted 1 died Culleton et al JAMA 298:1291, 2007 16

  16. Result: LV Mass Gm (SD) Estimated Treatment Effect on LV Mass (Gm) Last observation carried forward (n=44): 15.3, CI (+1.0, +29.6 ) Observed data only (n=35): 19.7, CI (+1.9, +37.4 ) Culleton et al JAMA 298:1291, 2007 17

  17. Nocturnal Home Hemodialysis (NHHD) Nocturnal Hemodialysis Improves Erythropoietin Responsiveness and Growth of Hematopoietic Stem Cells • 16 patients switched from conventional HD to NHHD • Kt/V urea increased from 1.27+0.06 to 2.23+0.09 • Phosphorus and PTH levels fell • BP and BP medications fell Chan JASN Express Dec 17 2008

  18. Nocturnal Home Hemodialysis (NHHD) • Hb rose from 11.3+0.3 to 12.5+0.4 Gm/dL with no change in EPO or iron • Cell culture studies and gene profiling showed up regulation of genes responsible for hematopoetic progenitor cells after more intensive HD. • NHHD increases growth and production of RBCs. Chan JASN Express Dec 17 2008

  19. Frequent Hemodialysis Network 2 parallel RCT • Comparing in-center 6x/wk dialysis to conventional 3x/wk dialysis • Comparing home nocturnal 6x/wk dialysis to conventional 3x/wk home dialysis

  20. FHN Study Designs Compare outcomes after 1 year Compare outcomes after 1 year Daily In-Center Patients from 10 regional centers Nocturnal Patients from 9 regional centers 250 pts randomized over 46 mo. 90 pts randomized over 27 mo. 1.5 months training + 12 months 6x/Week Nocturnal HD 12 months 3x/Week Conventional Home HD 12 months 6x/Week Daily In-center HD 12 months 3x/Week Conventional In-center HD

  21. Standard weekly Kt/V urea

  22. Phosphorus removal

  23. Beta-2-microglobulin clearance

  24. Co-Primary Outcomes Composite of 1-year mortality and change in LV mass by cardiac cine-MRI Composite of 1-year mortality and change in RAND PHC from SF- 36 25

  25. 9 Main Outcome Domains

  26. Clinical Centers for Daily TrialRRI and UCSF/Stanford Cores Univ. of Western Ontario – Dr. Robert Lindsay Washington Univ. (MO) – -- Dr. Brent Miller RRI: New York City (NY) – Dr. Peter Kotanko Vanderbilt University (TN) – Dr. Gerald Schulman Wake Forest University (NC) – Dr. Michael Rocco UCSF/Stanford – Dr. Glenn Chertow Univ. California, Davis – Dr. Thomas Depner Peninsula Dialysis: (CA) –Dr. George Ting UCLA – Dr Anjay Rastogi UCSD – Dr. Ravindra Mehta 27

  27. Clinical Centers for Nocturnal Trial Univ. of British Columbia – Dr. Michael Copland Humber River Hosp – Dr. Andreas Pierratos University of Toronto – Dr. Chris Chan Univ. of Western Ontario – Dr. Robert Lindsay Rubin Dialysis (NY) – Dr. Christopher Hoy University of Iowa – Dr. John Stokes Lynchburg Nephrology – Dr. Robert Lockridge Jr. Wake Forest University – Dr. John Burkart Washington University – Dr. Brent Miller

  28. Randomized Subjects Daily Nocturnal Goal 250 90 Enrolled 378 118 Randomized 245 81

  29. Trial Timelines DailyNocturnal Randomization Ends 3/2009 5/2009 Study Period Ends 3/2010 5/2010 Report Results late 2010-2011

  30. Cost-Effectiveness of Frequent in-Center Hemodialysis • Monte Carlo simulation model • Inputs: • Various frequencies and duration of HD (3-6x/wk, 2-4.5 hrs/session) • Outcomes: costs, life expectancy, QALY • Assumptions on potential effects of frequent dialysis on outcomes – (ex: 32% reduction in mortality with 6x/wk) Lee CO et al JASN 19:1792, 2008

  31. Cost-Effectiveness of Frequent in-Center Hemodialysis • Incremental cost-effectiveness ratio will be at least $75,000/ life year gained • None of the strategies using 6x/wk HD achieved a cost-effectiveness ratio of < $125,000/ life year gained Lee CO et al JASN 19:1792, 2008

  32. Cost-Effectiveness of Frequent in-Center Hemodialysis How could costs “break even”? • If the per-session costs were reduced between 32 and 43% • Reduction in hospitalization rate • For 4 HD/wk, need to reduce hospitalization to 46% of current rate • For 5 HD/wk, need to eliminate hospitalizations Lee CO et al JASN 19:1792, 2008

  33. Cost-Effectiveness of Frequent in-Center Hemodialysis Conclusions • More frequent in-center HD strategies would likely increase ESRD program costs considerably. • Transition to home-based therapies will be required to derive any benefit that might be present without incurring excessive costs. Lee CO et al JASN 19:1792, 2008

  34. In-Center Nocturnal HD (INHD) • 16 patients in New Haven switched from conventional to INHD • Kt/V urea rose from 1.2+0.16 to 2.6+0.65 • UF rate fell from 10.3+4.5 to 5.9+1.7 mL/hr/kg • Phosphorus fell from 5.3+1.3 to 4.4+1.1mg/dL • No change in psychosocial assessments (QoL) Troidle Adv Chronic Kid Dis 14:244,2007

  35. In-Center Nocturnal HD (INHD) • 39 patients in Toronto switched from conventional to 8 hr INHD • URR increased from 74% to 89% • Phosphorus fell from 5.9 to 3.7 mg/dL • Number of antihypertensive drugs: 2.0 to 1.5 • ESA use fell significantly • QoL, sleep, intradialytic cramps, appetite, energy level all improved significantly Bujega CJASN April 2009

  36. In-Center Nocturnal HD (INHD) • 224 pts in Turkey switched from conventional to 8 hour INHD • Compared prospectively with matched cohort 224 pts on conventional 4 hour HD 3 days/wk • INHD patients had • 25% hospitalization rate • 78% reduction in mortality • Less intradialytic hypotension, lower phosphate, reduced arterial stiffness • Improved cognitive function Ok E: ASN abstract F-FC-317 2008

  37. Frequent HD in USA: Current Status

  38. NxStage Growth 2004 to 2008 Courtesy Dr Lockridge

  39. International Quotidian Dialysis Registry • Standard Daily HD: >2 hrs, 5-7x/wk • Nocturnal HD: > 6 hrs, 3-7x/wk • Enrollment as of Mar, 2009: US 1,260 ANDATA 1,210 Canada 225 Total 2,695 Nesrallah GE, on behalf of the quotidian dialysis international working group

  40. Conclusions • More intensive dialysis is needed to improve ESRD patient outcomes • Observational trials suggest better anemia care, phosphorus control, fluid and BP management with intensive HD • Retrospective analysis shows improved survival with intensive dialysis

  41. Conclusions • Frequent in-center HD (4-6 HD/wk) is more costly - unless per-treatment HD costs fall • Frequent home HD (4-6HD/wk) is increasing slowly • NHHD is promising, but utilized by few patients • INHD is the fastest growing – in US and internationally - with more efficient use of facility space improving financial viability

  42. Conclusions • RCT of NHHD and daily in-center HD in progress • International Quotidian Dialysis Registry may give us meaningful information on the effect of intensive HD on mortality and hospitalization

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