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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

Dialysis21stCentury.ppt

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Page 1: Dialysis21stCentury.ppt

Dosing Dialysis: Is More Better?

“Dialysis in the 21st Century”

Chicago, Illinois

September 19, 2004

Robert S. Lockridge Jr. MD

Lynchburg Nephrology Physicians

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"Thinking Outside the Box"

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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

Page 4: Dialysis21stCentury.ppt

Dosing Dialysis: Is More Better?

Demographics of the ESRD population

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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

(%)

Page 6: Dialysis21stCentury.ppt

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

Page 7: Dialysis21stCentury.ppt

Modalities of U.S. Dialysis Patients

Source: USRDS 2000 Annual Data Report Networks 2000 Annual Report

1990 1992 1994 1996 1998 2000

Page 8: Dialysis21stCentury.ppt

Source: Networks 2000 Annual Report

Dialysis Patients Employed or Students

Employed or Students

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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

Page 10: Dialysis21stCentury.ppt

Cost Centers for Dialysis Patients

Hospitalization

$23,000

$7,000

Page 11: Dialysis21stCentury.ppt

Fewer Nursing Candidates Total Enrollments and Graduations, All RN Programs

1988 1994 2000

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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

Page 13: Dialysis21stCentury.ppt

Dosing Dialysis: Is More Better?

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

Page 14: Dialysis21stCentury.ppt

“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

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“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

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Dosing Dialysis: Is More Better?

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

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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

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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

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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

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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

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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

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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

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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

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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

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Dosing Dialysis: Is More Better?

Does three times per week affect adequacy?

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Three Times per Week Dialysis

Source: Gotch et al, Kidney International, Vol. 58, Suppl. 76 (2000), pp S3-18

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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

Page 28: Dialysis21stCentury.ppt

Dosing Dialysis: Is More Better?

Overview of Lynchburg’s NHHD Data

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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

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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

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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

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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

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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

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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

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Quality of Life Improvements

Physical ComponentSummary Score p = 0.007

Mental ComponentSummary Score p = 0.002

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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

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60% Reduction in Hospital Days42% Reduction in Hospital Admissions

Admissions p = 0.008

Days p = 0.002

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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

Page 39: Dialysis21stCentury.ppt

Hypertension - Improved BP control

p=0.0003 p=0.0001

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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

Page 41: Dialysis21stCentury.ppt

Blood Pressure Medications

p=0.001

Page 42: Dialysis21stCentury.ppt

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

Page 43: Dialysis21stCentury.ppt

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

Page 44: Dialysis21stCentury.ppt

CA/PO4 Product on NHHD

p=0.001

Page 45: Dialysis21stCentury.ppt

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

Page 46: Dialysis21stCentury.ppt

Dry Weight

p=0.07

Page 47: Dialysis21stCentury.ppt

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

Page 48: Dialysis21stCentury.ppt

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

Page 49: Dialysis21stCentury.ppt

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

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Interlink Device and Injection Caps

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Catheter Locking Device

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Catheter with Wings Removed and Dressing on

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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

Page 54: Dialysis21stCentury.ppt

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

Page 55: Dialysis21stCentury.ppt

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

Page 56: Dialysis21stCentury.ppt

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

Page 57: Dialysis21stCentury.ppt

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

Page 58: Dialysis21stCentury.ppt

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