Dosing Dialysis: Is More Better

1
Dosing Dialysis Is More Better?

• Dialysis in the 21st Century
• Chicago, Illinois
• September 19, 2004
• Robert S. Lockridge Jr. MD
• Lynchburg Nephrology Physicians

2
"Thinking Outside the Box"
3
Dosing Dialysis Is More Better?

• Demographics of the ESRD population
• Efforts of renal community and CMS to improve
  quality of care of dialysis patients
• Results from USRDS 2002 Annual Report concerning
  Core Indicators, hospitalizations and mortality
• Does three times per week affect adequacy?
• Overview of Lynchburgs NHHD data

4
Dosing Dialysis Is More Better?

• Demographics of the ESRD population

5
Cardiovascular Disease MortalityGeneral
Population vs ESRD Patients
Annual CVD Mortality ()
Dialysis Female
Dialysis Black
Dialysis White
Age (years)
GP General Population.
Foley RN, et al. Am J Kidney Dis.
199832S112-S119.
6
Growth of U.S. Dialysis Patients
Source USRDS 2000 Annual Data Report
Networks 2000 Annual Report
7
Modalities of U.S. Dialysis Patients
1990 1992 1994
1996
1998 2000
Source USRDS 2000 Annual Data Report
Networks 2000 Annual Report
8
Dialysis Patients Employed or Students
Employed or Students
Source Networks 2000 Annual Report
9
ESRD Population
10
Cost Centers for Dialysis Patients

• Hospitalization
• 23,000

7,000
11
Fewer Nursing Candidates Total Enrollments and
Graduations, All RN Programs
1988
1994
2000
12
Nephrology Manpower Issues
SourceAbt Report 1995
13
Dosing Dialysis Is More Better?

• Efforts of renal community and CMS to improve
  quality of care of dialysis patients

14
Quality Care for Our Patients

• 1990-1999
• Major Network initiative to monitor anemia,
  nutrition, and adequacy in the 90s
• End Stage Renal Disease Managed Care
  Demonstration Project of 1996
• Quality improvement by DOQI standards 1997

15
Quality Care for Our Patients

• 2000-2003
• Quality improvement by K/DOQI standards 2000
• Hemo Study completed 2002
• Network Access (Fistula First) initiative 2003
• Proposed ESRD Disease Management Demonstration
  Project of 2003 ending 2008
• NIH/CMS Daily Dialysis Study ending 2008

16
Dosing Dialysis Is More Better?

• Results from USRDS 2002 Annual Report concerning
  Core Indicators, hospitalizations and mortality

17
Hemoglobin-Epogen Trend
USRDS 2002 ADR
18
Urea Reduction Rate
USRDS 2002 ADR
19
Urea Reduction Rate
USRDS 2002 ADR
20
Adjusted Admission Rates per 1000 Patient Years
for Prevalent ESRD Population
USRDS 2002 ADR
21
Adjusted Hospital Admission Rate per 1000 Patient
Years

• Medicare patients (1998-2000) 500
  admissions per 1000 patient years
• Prevalent ESRD patients (2000) 1900
  admissions per 1000 patient years
• Prevalent transplant patients (2000)
  807 admissions per 1000 patient years

22
Adjusted One Year Death Rate per 1000 Patient
Years for Incident ESRD Patients
USRDS 2002 ADR
23
Adjusted One Year Death Rate per 1000 Patient
Years for Prevalent ESRD Patients
USRDS 2002 ADR
24
Annual Death Rates per 1000 Patient Years at Risk
Prevalent Patients Adjusted 2000

• ESRD Population 177.6
• Dialysis Patients 234.1
• Hemodialysis Patients 236.7
• Peritoneal Patients 219.9
• Transplant Patients
  34.7

25
Dosing Dialysis Is More Better?

• Does three times per week affect adequacy?

26
Three Times per Week Dialysis
Source Gotch et al, Kidney International, Vol.
58, Suppl. 76 (2000), pp S3-18
27
Hemo Study 2002Why No Significant Change?
NHHD
Long Group
Short Group
28
Dosing Dialysis Is More Better?

• Overview of Lynchburgs NHHD Data

29
Demographics of 51 NHHD Patients as of 7-31-04

• Average Age 54.4 years (Range 26.7-82.7 years)
• Average Weight 81.3 kg (Range 38-156 kg)
• 23 Black Patients, 29 White Patients
• 33 Men, 19 Women
• Education lt HS 10, HS 25, HSCollege 14,
  Undergraduate 1, Graduate 2

30
Demographics of NHHD Program 9-4-97 to 7-31-04

• Completed Training 52
• Currently in Program at Home 32
• Left Program During Training 3
• Deaths 4
• Left Program After Completing Training
  Transplanted
  7
• For Medical Reasons
  6
• For Compliance 2
• Personal Choice 1

31
Demographics of NHHD Program 9-4-97 to 7-31-04

• Patient months on NHHD 1,566.4
• Total treatments at home 34,586
• Longest patient time in months 81.7
• Shortest patient time in months
  0.3
• Average patient time in months 30.1

32
Treatment Parameters as of 8-17-04

• Treatment time 5-9 hours, five or six nights or
  days/week
• BFR 200-250 cc/minute
• DFR 200-300 cc/minute
• Dialysate K 2.0 mEq/L, HC03 35 mEq/L, Na 137
  mEq/L, Ca 3.0-3.5 mEq/L
• Machine - Fresenius 2008 H, Fresenius 2008 K,
  Fresenius 2008 Home K
• F60 Reusable Dialyzer

33
Longitudinal Study of NHHD from 9-1-97 to
5-31-03

• 25 patients at one year
• 19 patients at two years
• 14 patients at three years
• 6 patients at four years
• 4 patients at five years

34
SF-36 PCS and MCS
35
Quality of Life Improvements
Physical Component Summary Score p 0.007
Mental Component Summary Score p 0.002
36
Hospital Days and Admissions
37
60 Reduction in Hospital Days42 Reduction in
Hospital Admissions
Admissions p 0.008
Days p 0.002
38
Systolic and Diastolic BP
Pre NHHD 5 Year N4
Pre NHHD 4 Year N6
Pre NHHD 1 Year N25
Pre NHHD 3 Year N14
Pre NHHD 2 Year N19
39
Hypertension - Improved BP control
p0.0001
p0.0003
40
Blood Pressure Categories
Pre NHHD 5 Year N4
Pre NHHD 4 Year N6
Pre NHHD 1 Year N25
Pre NHHD 3 Year N14
Pre NHHD 2 Year N19
41
Blood Pressure Medications
p0.001
42
Phosphate Binder Usage (number of
tablets/day-includes ALL binders)
43
CA/PO4 Product on NHHD
44
CA/PO4 Product on NHHD
p0.001
45
Dry Weight
46
Dry Weight
p0.07
47
Hemogloblin
5 Year N4
2 Year N19
4 Year N6
1 Year N25
3 Year N14
48
Mortality

• Mortality rate calculated on 35 out of 40
  patients in the program
• 2 patients not included because they were
  transplanted within 14 days of starting NHHD
• 3 patients not included because they were in the
  program less than 3 months
• 2 patients died from 10-5-97 to 4-30-03
• 2.4 deaths per patient-year

49
Internal Jugular Tunneled Catheters
Used in NHHD Program as of 4-30-04

• Total Patients with Catheters 42
• Total Catheters
  124
• Average Catheter Life (months) 9.0
• Longest Catheter Life (months) 74.7
• Shortest Catheter Life (months) 0.2

50
Interlink Device and Injection Caps
51
Catheter Locking Device
52
Catheter with Wings Removed and Dressing on
53
Catheter Infection Rate for NHHD Program as of
4-30-04

• 1120.5 Months on NHHD at home
• 0.35 Exit Site Infections per 1000 Patient Days
• 0.53 Catheter Sepsis per 1000 Patient Days
• 0.88 Total Infections per 1000 Patient Days

54
Fistula Data in NHHD Program as of 4-30-04

• Patients who used Fistula 17
• Patients attempting to use Fistula
  5
• Patients that went home with Fistula 10
  
• Clotted Fistula requiring revision 2
• Fistula Months on NHHD at home 243.9
• Exit Site Infections 1
• Sepsis from Fistula
  0

55
Graft Data in NHHD Program as of 4-30-04

• Patients who used Graft 3
• Patients attempting to use Graft 2
• Patients that went home with Graft 1
  
• Clotted Graft requiring revision 0
• Graft Months on NHHD at home 27.3
• Exit Site Infections 0
• Sepsis from Graft
  0

56
Conclusions

• By the Year 2010 the ESRD population and the cost
  to the Medicare ESRD Program will double
• Pushing the Core Indicators in a three time per
  week treatment schedule does not appear to affect
  hospital admissions and mortality
• Tunneled IJ catheters are effective and safe
  permanent access for NHHD patients
• AV fistula and AV grafts are effective and safe
  permanent access for NHHD patients

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Conclusions

• Daily Dialysis improves
• Quality of life
• Hospital admissions and hospital days
• Blood pressure control with fewer medications
• Calcium/phosphorus product with no phosphate
  binders
• Nutritional status
• Mortality

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Conclusions

• Daily Dialysis improves outcomes because this new
  modality offers a higher Renal Replacement Dose
• Standard three times per week dialysis provides
  about 10 ml/min creatinine clearance
• Short daily dialysis provides about 20 ml/min
  creatinine clearance
• Nocturnal dialysis provides greater than 30
  ml/min creatinine clearance