Hemodiafiltration in Europe : Trends, Practices, Outcomes & Perspectives

Size: px

Start display at page:

Download "Hemodiafiltration in Europe : Trends, Practices, Outcomes & Perspectives"

Cleopatra Evans
6 years ago
Views:

1 Hemodiafiltration in Europe : Trends, Practices, Outcomes & Perspectives Prof. Bernard Canaud Nephrology, Dialysis and Intensive Care Lapeyronie Hospital CHRU Montpellier - France

2 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.

3 Outlines, HDF in Europe HDF trends over the last five years Legal and technical aspects of HDF Practice patterns of HDF Outcomes of recent studies Perspectives of HDF

4 Outlines, HDF in Europe HDF trends over the last five years Legal and technical aspects of HDF Practice patterns of HDF Outcomes of recent studies Perspectives of HDF

5 Hemodialysis in Europe, EEC 2008 Number of patients Total HD HDF PD TX

6 Trends of HDF in Europe over the 5 last years N of HDF treated patients Germany Italy Turkey France United Kingdom Spain Portugal Greece Romania Belgium Netherlands Hungary Czech Republic Serbia Austria Sweden Switzerland Slovakia Denmark EU 2010 HD treated patients : Online HDF treated : Bag HDF treated : 3550

Prevalence of HDF in Europe in 2010 Percent of HDF treated patients, % 1.

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

7 Prevalence of HDF in Europe in 2010 Percent of HDF treated patients, % HD treated patients : Online HDF treated : Bag HDF treated :

8 Repartition of HDF versus HD treated patients Denmark Slovakia Switzerland Sweden Austria Serbia Czech Republic Hungary Netherlands Belgium Greece Portugal Spain United Kingdom France Italy Germany 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

9 Prevalent counts of HDF treated pts in Europe 70,000 60,000 50,000 40,000 Total HDF on-line HDF 30,000 20,000 10,000 0 bag HDF

10 Percentages of HDF treated pts in Europe 30% 25% 20% 15% 10% 5% 0% Total HDF on-line HDF bag HDF

11 Outlines, HDF in Europe HDF trends over the last five years Legal and technical aspects of HDF Practice patterns of HDF Outcomes of recent studies Perspectives of HDF

12 SECTION II. Haemodialysis adequacy EBPG, Nephrol Dial Transplant (2002) 17 [Suppl 7]: 1-96

13 SECTION IV. Dialysis fluid purity EBPG, Nephrol Dial Transplant (2002) 17 [Suppl 7]: 1-96

14 Ultrapure water already a standard for contemporary water in dialysis

15 Ultrapure dialysis fluid is becoming a new standard

16 Water treatment system, Basic principles µfilter 0.1µ + Recirculating Loop Dialysis Station µfilter Activated Charcoal RO RO Tap Water Softener µfilter µfilter Pump 0.1µ +

17 Water treatment system and distribution loop Water treatment system Water distribution loop Material Connectors Tubing design Disinfection process Automated procedures Heat and mixed disinfection Water treatment monitoring Resistivity, msi Pressure, Chloride monitoring Filter change periodicity

18 Water and dialysis fluid tend to the same degree of microbiological purity EBPG guideline for fluid purity Maximum levels Regular Water Ultrapure Water Ultrapure Dialysis Fluid Microbial contamination (CFU/ml) Sensitized methods Bacterial endotoxins (IU/ml) LAL <100 <0.1 <0.1 <0.25 <0.03 <0.03

19 Ultrapure dialysis fluid is now recognized as a new standard of contemporary dialysis Nephrol Dial Transplant 2002; 17 [Suppl 7]

On-line HDF, post-dilution mode 400 110 700 810 Blood Flow Ultrafiltrate (Weight loss)

20 On-line HDF, post-dilution mode Blood Flow Ultrafiltrate (Weight loss) Ultrafiltrate (Fluid balance) Ultrapure dialysis fluid 700 Ultrafilter Substitution fluid

21 On-line HDF, pre-dilution mode Blood Flow UF Substitution fluid UF Ultrapure dialysis fluid Ultrafilter

22 HDF machines approved for on-line HDF therapies European Union Label Bellco Formula B.Braun Dialog + Gambro AK 200S/ Ultra Nikkiso DBB-05 FMC 4008 FMC 5008 Gambro Innova

23 Outlines, HDF in Europe HDF trends over the last five years Legal and technical aspects of HDF Practice patterns of HDF Outcomes of recent studies Perspectives of HDF

24 Common prescription of on-line HDF 4hrs x 3 Weekly HDF session Highly permeable synthetic membrane Large surface area > 1.8 m 2 Ultrapure bicarbonate dialysis fluid High blood flow Effective Qb: ml/min High dialysate flow diffusive dose ml/min High volume of substitution convective dose Post-dilution (Q sub : 100 ml/min, 24 l / session) Pre-dilution (Q sub : 200 ml/min, 48 l / session) Antithrombotic Unfractionned heparin or Low molecular weight heparin

25 Hemodiafiltration Trends by Country % of Patients 40% 30% 20% 10% FR IT GE UK SP 0% 1 ( ) 2 ( ) Study Phase (years) 3 ( ) SW BE UK GE SP ANZ JP 4 (2009-Present) DOPPS 1-4 Sample Patients* ( )

26 HDF Trends by Country % of Patients 100% 80% 60% 40% 20% 0% Phase: Miss-flux HD High-flux HD Low-flux HD High-volume HDF Low-volume HDF ANZ BE CA FR GE IT JP SP SW UK US DOPPS 2-4 Sample Patients* ( ) 54 85

27 Facility % of Patients on HDF, by Phase and Country Facility % of Patients 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% ANZ BE* FR GE IT SP* SW* UK* JP All DOPPS 2-4 Sample Patients* ( )

28 Distribution of Mean Replacement Fluid Volume for Patients on HDF, by Country Volume of replacement fluid (Liters) Percentile 95th 75th 50th 25th 5th 0 ANZ 50 BE 86 FR 184 GE 142 DOPPS 2-4 Sample Patients* ( ) IT 270 JP 73 SP 56 Country across phase 1-3 SW 129 UK 69 All 1059

29 Mean Replacement Fluid Volume, by Country % of Patients 100% 80% 60% 40% 20% 0% Phase: L L 5-15 L ANZ BE CA FR GE IT JP SP SW UK US All DOPPS 2-4 Sample Patients* ( ) 7 5 6

30 Outlines, HDF in Europe HDF trends over the last five years Legal and technical aspects of HDF Practice patterns of HDF Outcomes of recent studies Perspectives of HDF

31 Comparison of online HDF vs Low Flux HD Turkish HDF Study 782 prevalent HD patients Post dilution HDF 391patients (17.2±1.3L/session) 24 months High Flux HD 391 patients Primary outcome : Composite all cause of death and non-fatal CV events Secondary outcome : Fatal CV events, Intradialytic complications, hospitalization Ok E et al, ERA-EDTA 2011, LBCT2

Patients treated with substitution volume > 17.

Overall Survival Cardiovascular Survival 1.0 1.

4 High Flux HD p=0.03 Cumulative survival 0.9 0.8 0.7 0.6 0.

32 Patients treated with substitution volume > 17.4 l per session (n = 194) have better overall and CV survival Overall Survival Cardiovascular Survival Cumulative survival HDF > 17.4 L HDF 17.4 High Flux HD p=0.03 Cumulative survival HDF > 17.4 L HDF 17.4 High Flux HD p= Months Months Ok E et al, ERA-EDTA 2011, LBCT2

33 Comparison of postdilution on-line HDF and HD (Turkish HDF Study) In adjusted Cox-regression analysis, HDF with substitution volume over 17.4 L was associated with a : 46% risk reduction for overall mortality [RR=0.54 (95% CI ), p=0.02] 71% risk reduction for cardiovascular mortality [RR=0.29 (95% CI ), p=0.003] compared to High Flux HD Ok E et al, ERA-EDTA 2011, LBCT2

4 6.6 years) Low Flux HD 356 patients Primary outcome : All cause mortality Secondary

34 Online HDF vs Low Flux HD CONTRAST Dutch Study The CONvective TRAnsport STudy 714 prevalent HD patients Post dilution HDF 358 patients (19.1±3L/session) 36 months ( years) Low Flux HD 356 patients Primary outcome : All cause mortality Secondary outcome : Composite fatal and non fatal major CV events Grooteman M et al, ERA-EDTA 2011, LBCT1

35 Comparison of postdilution on-line HDF versus low flux HD The incidence of all cause mortality was not different 121/1000 vs. 128/1000 pt-years for HDF vs. low flux HD Hazard ratio 0.91; 95% confidence interval [CI], 0.70 to 1.17 The incidence of fatal and non fatal cardiovascular events was not different 127/1000 pt-years vs.111/1000 pt-years Hazard ratio 1.12; 95% CI, 0.86 to 1.46 Grooteman M et al, ERA-EDTA 2011, LBCT1

36 High convective dose appears beneficial for reducing all cause mortality A graded benefit on all cause mortality was observed in patients treated with HDF that received high convection volumes. Over 20 liter/treatment was associated with a reduction of mortality risk (hazard ratio 0.66; 95% confidence interval , p=0.03). Grooteman M et al, ERA-EDTA 2011, LBCT1

37 Outlines, HDF in Europe HDF trends over the last five years Legal and technical aspects of HDF Practice patterns of HDF Outcomes of recent studies Perspectives of HDF

Convective Therapies European Dialysis Working Group

38 ERA-EDTA council has approved the creation of a working group dedicated to dialysis First mission is focused on Convective Therapies European Dialysis Working Group Launching meeting was at the ERA-EDTA annual meeting in Prague

39 Convective therapies: online HDF, HF Four major goals of the WG 1. Definition and quantification of efficacy 2. Safety standards, regulation and guidelines 3. Short and long term clinical effects and outcome 4. Evidence based and educational issues

40 Coordination with KDIGO Novel techniques and innovation in blood purification: How can we improve clinical outcomes in hemodialysis? Pre-meeting 13 October 2011

41 Coordination with JSHDF?

42 A excellent opportunity to promote safe and effective HDF therapies worldwide HDF

43 Take home message On-line HDF is gaining everyday in popularity in Europe On-line HDF provides today the best and more versatile modality of renal replacement therapy On-line HDF enhances solute removal of middle molecule sized uremic toxins and reduces inflammatory profile of CKD patients On-line HDF tends to reduce morbidity and mortality in CKD patients Convective dialysis dose, a surrogate of substitution volume, is positively associated with better survival

HEMODIALFILTRATION LITERATURE REVIEW AND PRACTICE CONSIDERATIONS 1.0 PRACTICE CONSIDERATIONS 2.0 CURRENT LITERATURE REVIEW

HEMODIALFILTRATION LITERATURE REVIEW AND PRACTICE CONSIDERATIONS This document was prepared at the request of the BC Hemodialysis Committee to provide a brief overview of the literature and to identify