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Dosing Dialysis: Is More Better?
“Dialysis in the 21st Century”
Chicago, Illinois
September 19, 2004
Robert S. Lockridge Jr. MD
Lynchburg Nephrology Physicians
"Thinking Outside the Box"
Dosing Dialysis: Is More Better?Demographics of the ESRD population Efforts of renal community and CMS to
improve quality of care of dialysis patientsResults from USRDS 2002 Annual Report
concerning Core Indicators, hospitalizations and mortality
Does three times per week affect adequacy?Overview of Lynchburg’s NHHD data
Dosing Dialysis: Is More Better?
Demographics of the ESRD population
Cardiovascular Disease MortalityGeneral Population vs ESRD Patients
Foley RN, et al. Am J Kidney Dis. 1998;32:S112-S119.
GP: General Population.
0.001
0.01
0.1
1
10
100
25-34 35-44 45-54 55-64 66-74 75-84 >85
GP Male
GP Female
GP Black
GP White
Dialysis Male
Dialysis Female
Dialysis Black
Dialysis White
Age (years)
An
nu
al C
VD
Mo
rtal
ity
(%)
128,674
158,913
194,451
224,081
245,910
276,106
0
50,000
100,000
150,000
200,000
250,000
300,000
1990 1992 1994 1996 1998 2000
Source: USRDS 2000 Annual Data Report Networks 2000 Annual Report
Growth of U.S. Dialysis Patients
Modalities of U.S. Dialysis Patients
Source: USRDS 2000 Annual Data Report Networks 2000 Annual Report
1990 1992 1994 1996 1998 2000
Source: Networks 2000 Annual Report
Dialysis Patients Employed or Students
Employed or Students
US Population 308 Million
ESRD Population
248,000 0.08 %
ESRD PopulationUS Population
Non-ESRD $175 Billion
ESRD $15 Billion
8 %
ESRD Expenditures
Non-ESRD Healthcare Expenditures
ESRD Population
Cost Centers for Dialysis Patients
Hospitalization
$23,000
$7,000
Fewer Nursing Candidates Total Enrollments and Graduations, All RN Programs
1988 1994 2000
1,180
630 350
500
430
160
1,592
158
Treating ESRD Dialysis Patients
Treating ESRD Transplant Patients
Treating Other Renal Patients
Other Patient Care
Research
Administration
Teaching
Other Activities
Total FTEs = 5000 Nephrologists
Nephrology Manpower Issues
Source:Abt Report 1995
Dosing Dialysis: Is More Better?
Efforts of renal community and CMS to improve quality of care of dialysis patients
“Quality Care for Our Patients” 1990-1999
Major Network initiative to monitor anemia, nutrition, and adequacy in the 90’s
End Stage Renal Disease Managed Care Demonstration Project of 1996
Quality improvement by DOQI standards 1997
“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
Dosing Dialysis: Is More Better?
Results from USRDS 2002 Annual Report concerning Core Indicators, hospitalizations and mortality
Hemoglobin-Epogen Trend
USRDS 2002 ADR
1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 20015
7
9
11
13
15
17
19
9.0
9.5
10.0
10.5
11.0
11.5
12.0
Hemoglobin
Weekly EPO dose
Urea Reduction Rate
USRDS 2002 ADR
1998 1999 20001998 1999 20000
20
40
60
80
100
1998 1999 2000
All patients FemaleMale
75+70-<7565-<7060-<65<60
Urea Reduction Rate
USRDS 2002 ADR
1993 1994 1995 1996 1997 1998 19990
20
40
60
80
100
1998 1999 2000
CPM Claims
75+70-<7565-<7060-<65<60
Adjusted Admission Rates per 1000 Patient Years for Prevalent ESRD Population
USRDS 2002 ADR
1,500
1,600
1,700
1,800
1,900
2,000
2,100
1991 1992 1993 1994 1995 1996 1997 1998 1999 2000
Adjusted Unadjusted
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
251 251
246
234
231 231
226 226
233230 231
210
215
220
225
230
235
240
245
250
255
1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000
Adjusted One Year Death Rate per 1000 Patient Years for Incident ESRD Patients
USRDS 2002 ADR
Adjusted One Year Death Rate per 1000 Patient Years for Prevalent ESRD Patients
USRDS 2002 ADR
173
170
172
173
171
173172 172
174
179
177
164
166
168
170
172
174
176
178
180
1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000
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
Dosing Dialysis: Is More Better?
Does three times per week affect adequacy?
Three Times per Week Dialysis
Source: Gotch et al, Kidney International, Vol. 58, Suppl. 76 (2000), pp S3-18
0
2
4
6
8
10
1 3 5 7 9 11Standard Weekly KT/V
Improvement
Hemo Study 2002Why No Significant Change?
Short Group
Long GroupNHHD
Dosing Dialysis: Is More Better?
Overview of Lynchburg’s NHHD Data
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: < HS 10, HS 25, HS+College 14, Undergraduate 1, Graduate 2
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
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
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
Longitudinal Study of NHHD from 9-1-97 to 5-31-03
25 patients at one year19 patients at two years14 patients at three years6 patients at four years4 patients at five years
SF-36 PCS and MCS
35.42 36.4534.28 34.02
36.00
49.46 48.47 47.9145.46 46.15
40.8943.11 42.66
46.25
51.80
57.92
52.56
55.85
52.73
56.53
0
10
20
30
40
50
60
70
1 Year N=25 2 Year N=18 3 Year N=14 4 Year N=6 5 Year N=4
PCS MCS
Pre NHHD Pre NHHD Pre NHHD Pre NHHD Pre NHHD
Quality of Life Improvements
Physical ComponentSummary Score p = 0.007
Mental ComponentSummary Score p = 0.002
Hospital Days and Admissions
1.77 1.69 1.75 1.69 1.62
8.20
8.72
9.38
8.74 8.58
1.120.89
1.16 1.29
0.30
4.60
3.02
4.50 4.41
0.60
0
1
2
3
4
5
6
7
8
9
10
1 Year N=25 2 Year N=19 3 Year N=14 4 Year N=6 5 Year N=4
Admissions per Year Days per Year
60% Reduction in Hospital Days42% Reduction in Hospital Admissions
Admissions p = 0.008
Days p = 0.002
Systolic and Diastolic BP
Pre NHHD 1 Year N=25
Pre NHHD 2 Year N=19
Pre NHHD 3 Year N=14
Pre NHHD 4 Year N=6
Pre NHHD 5 Year N=4
Hypertension - Improved BP control
p=0.0003 p=0.0001
Blood Pressure Categories
Pre NHHD 1 Year N=25
Pre NHHD 2 Year N=19
Pre NHHD 3 Year N=14
Pre NHHD 4 Year N=6
Pre NHHD 5 Year N=4
Blood Pressure Medications
p=0.001
Phosphate Binder Usage (number of tablets/day-includes ALL binders)
5
0 0 0 0 00
1
2
3
4
5
6
Pre
N=35
1 Year
N=25
2 Year
N=19
3 Year
N=14
4 Year
N=6
5 Year
N=4
NUMBER OF BINDERS
CA/PO4 Product on NHHD
50.08 49.42
46.7147.83
41.50
35.6233.96
38.03
32.08 31.90
0
10
20
30
40
50
60
1 Year N=25 2 Year N=19 3 Year N=14 4 Year N=6 5 Year N=4
Pre NHHD NHHD
CA/PO4 Product on NHHD
p=0.001
Dry Weight
80.48
72.55 71.8670.17
59.38
79.92
75.26 74.1876.37
61.75
0.00
10.00
20.00
30.00
40.00
50.00
60.00
70.00
80.00
90.00
1 Year N=25 2 Year N=19 3 Year N=14 4 Year N=6 5 Year N=4
Pre NHHD NHHD
Dry Weight
p=0.07
Hemogloblin
11.52 11.51 11.4811.07 10.83
11.80 11.9512.21
12.72
12.03
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
1 Year N=25 2 Year N=19 3 Year N=14 4 Year N=6 5 Year N=4
Pre NHHD NHHD
1 Year N=25
2 Year N=19
3 Year N=14
4 Year N=6
5 Year N=4
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
Internal Jugular Tunneled Catheters Used in NHHD Program as of
4-30-04Total Patients with Catheters 42Total Catheters 124 Average Catheter Life (months) 9.0 Longest Catheter Life (months) 74.7Shortest Catheter Life (months) 0.2
Interlink Device and Injection Caps
Catheter Locking Device
Catheter with Wings Removed and Dressing on
Catheter Infection Rate for NHHD Program as of 4-30-04
1120.5 Months on NHHD at home0.35 Exit Site Infections per 1000 Patient
Days0.53 Catheter Sepsis per 1000 Patient Days0.88 Total Infections per 1000 Patient Days
Fistula Data in NHHD Program as of 4-30-04
Patients who used Fistula 17Patients attempting to use Fistula 5Patients that went home with Fistula 10 Clotted Fistula requiring revision 2Fistula Months on NHHD at home 243.9 Exit Site Infections 1Sepsis from Fistula 0
Graft Data in NHHD Program as of 4-30-04
Patients who used Graft 3Patients attempting to use Graft 2Patients that went home with Graft 1 Clotted Graft requiring revision 0Graft Months on NHHD at home 27.3 Exit Site Infections 0Sepsis from Graft 0
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
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
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