dialysis outcomes and practice patterns studyhdf-j.jp/pdf/06bernard jm canaud (france).pdf3 months;...

D PPS Dialysis Outcomes and Practice Patterns Study

Hemodiafiltration vs. Conventional Hemodialysis:

Use and Association with Outcomes

Bernard Canaud, MDLapeyronie University Hospital - Montpellier, France

Opening remarks and special thanks…

By my presence here at the 17th symposium, I wish to express my deepest sympathy to friends and Japanese people in general, especially those living in the northeastern part of the country and have been particularly affected by the earthquake, the tsunami and the Fukushima catastrophe.

Indeed, relatively powerless in face of this disaster we sympathize and especially appreciated the courage and dignity of your people. We want to extend our most sincere friendship and best wishes with lot of courage for a rapid reconstruction of your country. We will pray for the missing people and their family.

開会の挨拶と感謝

ここJSHDF第17回シンポジウムで私の存在によって、私は国の

北東部では、一般の友人と日本の人々に特に生活を心から同情を申し上げますと、特に地震、津波や影響を受けている福島の大惨事。

確かに、この災害の面で相対的に無力私たちは共感し、特にあなたの人々の勇気と尊厳を高く評価しています。私たちはあなたの国の急速な復興のために勇気を私たちの最も誠実な友情とご多幸を拡張する。私たちは、行方不明になった人とその家族のために祈るだろう。

Outline of presentation

• Rationale for using on-line hemodiafiltration in CKD patients

• Technical aspects of on-line hemodiafiltration• Prevalence of hemodiafiltration use• Patterns of use of HDF• Volume of substitution and inflammation risk• Inflammatory markers of online HDF vs HD treated

patients• Outcomes of online HDF vs HD treated patients

HDF increases removal of middle molecules

Maduell F et al, Am J Kidney Dis 2002; 40:582

81

69

4

82

70

5461

25

72

64

75

63

83

0

20

40

60

80

100

Urea Creat Osteoc B2M Myogl

LF-HDHF-HDol-HDF

60D 113D 5.8kD 11.8kD 17.2kD

Percent reduction per session, %

Canaud B et al, Kidney Int 2006; 69: 2087-2093

Distribution of dialysis modality for prevalent patients

12.8 12.7 12.6

8.9

0

4

8

12

16

20

Low Flux HD High Flux HD Low Efficiency HDF

High Efficiency HDF

Dea

ths/

100

pt. y

ears

Crude mortality for patients treated by HDF is reduced


5-14.9 L 15-24.9 L l

Mortality risk for patients receiving high efficiency HDF vs. HD is reduced

35% hs

7% ns


On-line HDF, Substitution fluid is produced by cold sterilization of dialysate

Substitutionfluid

Ultrafilter

Dialysate

Dialysis Fluid500-800 ml/min

Blood Flow

400 ml/min

Fluid BalancingModule

On-line HDF, post-dilution mode

Dialysis Fluid500-800 ml/min

Ultrafilter

Blood Flow

100ml/min

400 ml/min

Substitution fluid

Dialysate


On-line HDF, pre-dilution mode

Ultrafilter

Substitution Fluid200 ml/min

Blood Flow

400 ml/minDialysis Fluid500-800 ml/min


PR β2-Microglobulin, %ß2-Microglobulin, Reduction Rate (%)

On-line HDF substitution volume (ml/min)

Convective dialysis dose is a linear function of substitution volume in online HDF

Lornoy W et al, Nephrol Dial Transplant. 2000: 15: 49-54

15 l 25 l5 l 31 l

Prevalence of HDF in Europe in 2010

0.130.16 0.18

0.13 0.140.18

0.48

0.29 0.30

0.19

0.42

0.330.26 0.27 0.28

0.67

0.55

0.20

0.000.100.200.300.400.500.600.700.800.901.00

HD treated patients : 294400 Online HDF treated : 50800 Bag HDF treated : 3550

Percent of HDF treated patients, %

Use of HDF and treatment characteristics

Characteristic(Mean)

Low-VolumeHDF

(n=549)

High-VolumeHDF

(n=603)

Low-Flux HD

(n=5,108)

High-FluxHD

(n=2,906)

Dialysis dose (spKt/V) 1.43* 1.58* 1.41 1.45

Treatment time (minutes) 233 247* 238* 243

Volume of replacement fluid (liters) 10.1 24.2 3.5 5.0

Actual blood flow rate 297.0 336.8 271.9 250.1

Dialysate flow 527.3 586.6 505.9 504.5

* p-value <0.05 compared to high-flux HD, adjusted for phase and country and accounted for facility clustering ANZ, Belgium, France, Germany, Italy, Spain, Sweden, UK

Hemodiafiltration Trends by Country– DOPPS 1-4 Sample Patients* (1996-2010)

ANZJP

BE

FRGE

GE

IT

SP

SP

SW

UK

UK

0%

10%

20%

30%

40%

1(1996-2000)

2(2002-2004)

3(2005-2008)

4(2009-Present)

Study Phase (years)

% of Patients

*Initial prevalent cross-sections who dialyzed 3 times/wk with vintage ≥3 months; DOPPS 4 data are preliminary; ANZ, BE and SW did not participate in DOPPS phase 1

HDF Trends by Country– DOPPS 2-4 Sample Patients* (2002-2009) –

2 3 2 2 5 4 06 2 4

16 11 114 5 2 3 4 1 2 3 4

100

6 5 4 311

246 10 22

43

9

67

14

0 13 4

8 8 18

33

1 4

11

0

65

32

3

4132 12

37

20

6

21 18 6

4447

24

3733 20

1816

1

4647

15

55

55 20

42

214

2514

2

17

49

70

3631

26

51

66

5

4639

22

2927

25

1521

12

52

62

39

27

34

38

27 10

18 34

5151 52

5485

12 1422 17

2436

12 13

89

2230

50

17 21

39

26 28

43

3017

54

2413

36

616

2720 20 24 22

32

13

0%

20%

40%

60%

80%

100%

2 3 4 2 3 4 2 3 4 2 3 4 2 3 4 2 3 4 2 3 4 2 3 4 2 3 4 2 3 4 2 3 4

Miss-flux HD High-flux HD Low-flux HD High-volume HDF Low-volume HDF% of Patients

ANZ BE CA GE ITFR JP SP SW UK USPhase:

*Initial prevalent cross-sections who dialyzed 3 times/wk with vintage ≥3 months;DOPPS 4 data are preliminary

Facility % of Patients on HDF, by Phase and Country

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2 3 4 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 2 3 4 1 2 3 4 3 4 1 2 3 4

Facility % of Patients

Initial prevalent cross-sections who dialyzed 3 times/wk with vintage ≥3 months * p-value <0.05 for test for trend for HDF use over time; †HDF was not used in Japan during DOPPS phases 1 and 2

ANZ BE* FR GE IT SP* SW* UK* AllJP†

Baseline Characteristics for HDF vs. HD (1)

Characteristic(Mean or %)

Low-VolumeHDF

(n=549)

High-VolumeHDF

(n=603)

Low-Flux HD

(n=5,108)

High-FluxHD

(n=2,906)Age (years) 62.9* 60.8* 63.0* 61.1

Male (%) 55% 68%* 55%* 60%

Time on dialysis (years) 6.9* 6.5* 4.6* 5.6

BMI 24.7 25.1 24.3* 25.2

Catheter use (%) 7%* 7%* 15%* 15%


Baseline Characteristics for HDF vs. HD (2)Characteristic (Mean or %)

Low-VolumeHDF

(n=549)

High-VolumeHDF

(n=603)

Low-Flux HD

(n=5,108)

High-FluxHD

(n=2,906)Comorbid Conditions: (%)CAD 40% 46% 42% 44%Cancer 14%* 10% 12%* 11%Other Cardiovascular diseases 49%* 41% 39%* 38%Cerebrovascular diseases 18% 15% 17%* 17%CHF 27% 32% 31% 32%Diabetes 22% 26% 26% 28%GI Bleed 4% 6% 5% 5%HIV 0% 0% 0% 1%Hypertension 76% 79% 76% 78%Lung disease 11% 13% 12% 13%Neurologic disorder 10% 8% 10% 10%Psychiatric disorder 25% 16% 20% 18%PVD 24% 29% 27% 29%Recurrent cellulitis/gangrene 7% 7% 8% 9%


Baseline Characteristics for HDF vs. HD (3)Characteristic(Mean)

Low-VolumeHDF

(n=549)

High-VolumeHDF

(n=603)

Low-Flux HD

(n=5,108)

High-FluxHD

(n=2,906)Hemoglobin (g/dl) 11.3 11.5 11.2* 11.6

Calcium (mg/dl) 9.5* 9.4 9.4 9.4

Phosphorous (mg/dl) 5.2 5.4 5.5 5.5

PO4 > 5.5 (mg/dl) (%) 41% 43% 45% 44%

Potassium (mEq/l) 5.4 5.2 5.2* 5.2

Bicarbonate (mEq/l) 22.0 22.3 22.5 22.7

Albumin (g/dl)) 3.77* 3.72 3.76* 3.81

Ferritin (ng/ml) 395.8 449.5 466.7 475.0

WBC count 7.1 7.0 7.2 7.1

TSAT 31.3 26.7 29.0 28.8

PCR 1.11 1.08 1.06* 1.07

CRP (mg/l) (median) † 6.0 6.0 7.0 7.0


Distribution of Mean Replacement Fluid Volume for Patients on HDF, by Country

0

5

10

15

20

25

30

35

40

45

50

ANZ50

BE86

FR184

GE142

IT270

JP73

SP56

SW129

UK69

All1059

Percentile

95th

75th

50th

25th

5th

Volume of replacement fluid (Liters)

Country across phase 1 - 3Initial prevalent cross-sections who dialyzed 3 times/wk with vintage ≥3 months;HDF not used in the US and Canada

Mean Replacement Fluid Volume, by Country– DOPPS 2-4 Sample Patients* (2002-2009) –

4 5

32

52

19

6

47

29

1

59

43

30

7160

43

8980

7

26 28 29

5 6

65

50 49 5039

29

43

73

59

48

76

65

53

65

89

39

50

61

28

18

38

3

1

93

74 71

41

7365

35

3747 41

48

53

54

23

9 5

29

6 102 7 9

1

22 198

19

2

2922

29

134

9 1217

0%

20%

40%

60%

80%

100%

2 3 4 2 3 4 2 3 4 2 3 4 2 3 4 2 3 4 2 3 4 2 3 4 2 3 4 2 3 4 2 3 4 2 3 4

30-50 L 15-30 L 5-15 L% of Patients

Phase:

*Initial prevalent cross-sections who dialyzed 3 times/wk with vintage ≥3 months;DOPPS 4 data are preliminary

ANZ BE CA GE ITFR JP SP SW UK AllUS

0.6 0.8 1.0 1.2 1.4 1.8

Ferritin >800 ng/mL

CRP >10 mg/L*

WBC > 8000 mL

Serum albumin <3.5 g/dL

Odds Ratio (95% CI)

IV analysisPatient model

Association of Modality with Inflammatory Markers

All models are adjusted for age, gender, race, vintage, BMI, catheter use, facility type, 13 comorbidities, albumin (except for model with albumin as outcome), prescribed blood flow rate, prescribed dialysate flow rate, phase, region and accounted for facility clustering; Region 1: UK, Sweden, Germany and Belgium; Region 2: France, Australia-New Zealand, Spain, and Italy*DOPPS 3 only

Ref = High-Flux HD Ref = High-Flux HD

Low-vol. HDFHigh-vol. HDFLow-flux HD

0.05 0.2 0.5 1.0 1.5 3.0 5.0

Any hospitalization

0.20 0.50 1.00 1.50

All-cause mortality

CV mortality

Infectious mortality

Adjusted for age, gender, race, vintage, BMI and catheter use, 13 comorbidities, hemoglobin, albumin and single pool Kt/V, dialysate flow and blood flow; stratified by phase and region and accounted for facility clustering; Region 1: UK, Sweden, Germany and Belgium; Region 2: France, Australia-New Zealand, Spain, and Italy

Hazard Ratio (95% CI)

IV analysisPatient modelRef = High-Flux HD

Low-vol. HDFHigh vol.-HDFLow-flux HD

Association of Modality with Mortality and Hospitalization

Infectioushospitalization

0.1 0.2 1.0 1.5 3.0

Ref = High-Flux HD

0.5

CV hospitalization

Conclusions

• Prevalence of HDF use is increasing among DOPPS facilities in Europe (20%), Japan (5%)

• High efficiency HDF using large volume of substitution (15-30l) and high convective dose is highly prevalent [33-68% in DOPPS 4]

• CRP is lower in facilities providing HDF modalities• Albumin remains constant in HDF treated patients• Morbidity and mortality tend to be lower in HDF treated

patients both at facility level particularly with large volume of substitution fluid

• Large convective dialysis dose (surrogate of volume of substitution) should be considered as a new target for improving patient outcomes

dialysis outcomes and practice patterns studyhdf-j.jp/pdf/06bernard jm canaud (france).pdf3 months;...

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