Post on 28-Dec-2015
From complex dream to simple reality: HighVolumeHDF – the standard therapy of the future. NOW!
How Technological Developments make better Treatment a Reality
Angelika KneppelFresenius Medical Care, Germany
EDTNA Corporate Education SessionMalmö, Sept. 1st, 2013
Cardioprotective Haemodialysis
The new Catalonian HighVolumeHDF study shows: HighVolumeHDF improves patient survival
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013 Page 2
Maduell F et al, J Am Soc Nephrol. 24 (2013)
Randomized controlled clinical trial with positive primary
outcome!
Improved survival
30% risk reduction in all-cause mortality (p=0.01)
33% risk reduction in cardiovascular mortality (p=0.06)
55% risk reduction in mortality from infection (p=0.03)
61% risk reduction in mortality from stroke (p=0.03)
Reduced treatment costs
22% risk reduction in all-cause hospitalisation (p=0.001)
Better patient well-being
28% risk reduction in incidence of hypotensive episodes (p<0.001)
Cardioprotective Haemodialysis
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
From ONLINE HDF to HighVolumeHDF
ONLINE stands for the preparation of the substitution fluid directly by the dialysis machine.
To achieve large substitution volumes therapeutic aspects have to be considered.
This therapy approach is what we call HighVolumeHDF.
Page 3
ONLINE was a technology for water preparation,
HighVolumeHDF is THE therapy approach.
Cardioprotective Haemodialysis
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
Water quality for HighVolumeHDF requires the same international standards as for High-Flux HD*
The combination of Online Purification Cascade & ONLINEplus at 5008 CorDiax / 5008S CorDiax
fulfils the required international standards1,2
Page 4
Reverse Osmosis
(RO)
Ready-made concentrate
fluid
Unlimitedsterile, non-pyrogenic substitution fluid
Dialysis fluid
ONLINEplus – Double-stage filtration system
Automated integrity test
1 ISO 13959:2009 2 ISO 23500:2011
* Local regulations may differ
Cardioprotective Haemodialysis
The Catalonian HighVolumeHDF study is part of a bigger picture…
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013 Page 5
Catalonian HighVolumeHDF Study (2013):
30% Risk reduction in all-cause mortality vs. high-flux HD (p=0.01)
(*High efficiency = Sub. volume > 21L)
DOPPS (2005):
High-efficiency* HDF reduces mortality risk (35 %) compared to Low-Flux HD (p=0.01)
(*High efficiency = Sub. volume 15–24.9 L/session)
Contrast (2012):
High-volume HDF* considerably reduces mortality risk compared to low-flux HD (p=0.003)
(*High-volume ≥21.95 L)
Turkish (2011):
HDF treatment with substitution volume › 17.4 L provides better cardiovascular and overall survival compared to high-flux HD (p=0.03)
All have one in common
– Volume matters!
Cardioprotective Haemodialysis
Volume matters – but how much is high-volume?
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013 Page 6
Cardioprotective Haemodialysis
Total convective volume per treatment1
~ 23 L
1 Delivered median volumes based on Maduell F. et al. 2013
Volume matters – but how much is high-volume?
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013 Page 7
Substitution volume
21 L
Weight loss
~ 2 L
Objective of HighVolumeHDF:
Vsub ≥ 21 L in postdilution
target substitution volume per treatment (without weight loss) for all patients
No negative impact with (too) high substitution volume is known yet
Achieving high substitution volumes requires good blood flow but also technology designed for HighVolumeHDF
Cardioprotective Haemodialysis
blood inlet
blood outlet
Achieving high substitution volume - blood flow limits the performance
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013 Page 8
~ 25% QB
QB
Haematocrit
Protein/ Protein bound water
Filterableplasma water Qspost
Example:
QB = 320 mL/min
FF = 25 %
Qcon = 80 mL/min
QUF = 10 ml/min
Qspost = 70 mL/min
Vsub = 17 L
QUF
Rule of thumb – Filtration Fraction [FF]
Performance limits in post-dilution HDF (schematic diagram)
QB = Blood flow rate ; Qcon = convective flow rateQspost = Substitution flow rate in post-dilution mode; QUF = Ultrafiltration rate (weight loss); FF = Filtration Fraction; Vsub = Substitution volume;
Cardioprotective Haemodialysis
Therapy driven:Patient related:
+
+
Crucial factors for HighVolumeHDF therapy- it is not just a matter of blood flow …
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013 Page 9
+
Good rheological conditions
+
High effective blood flow
+Optimal
filtration flow
Convective dose(= max. substitution)
Treatment time
FX CorDiax HDF
5008S CorDiax & 5008 CorDiax
• AutoSub plus
• MIXED HDF
+
Cardioprotective Haemodialysis
Achieving high volumes is also a matter of using technology designed for HighVolumeHDF
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013 Page 10
4008 HONLINEplus®“Advanced online Preparation with DIASAFE®plus”
5008Therapy System“Online haemodiafiltration as standard treatment”
5008 CorDiax &5008S CorDiax“With AutoSub plus HighVolumeHDFbecomes as simple and safe as HD”
PAST TODAY
How to set-up the substitution volume?
Cardioprotective Haemodialysis
Starting point: Haemodiafiltration with manual volume control
Requires manual calculation, setting & adaptation of the substitution rate during the treatment
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013 Page 11
Example:
QB = 320 mL/min
Qcon = 80 mL/min
QUF = 10 ml/min
Qspost = 70 mL/min Manual setting of substitution rate
Sub volumes tend to be lower than possible
Cardioprotective Haemodialysis
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
Milestone 1: AutoSub in 5008 Therapy System
Objective: Automatic setting of substitution rate for alarm-free treatment
Substitution rate automatically calculated via formula
(based on Hct, TP, dialyser type, UF and TMP drift)
Automatic decrease of substitution rate in case of pressure increase
A formula never considers all parameters with impact on flow conditions & blood viscosity
User has to enter patient’s latest available lab values
Page 12
Calculation andautomatic decrease of
substitution rate
Sub volumes tend to be lower than possible
Cardioprotective Haemodialysis
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
Milestone 2: AutoSub plus in 5008 CorDiax*
Objective: Automatic maximisation of substitution rate for alarm-free treatment
Page 13
5008 CorDiax5008S CorDiax
* and 5008S CorDiax
Cardioprotective Haemodialysis
The challenge of HighVolumeHDF: Maximizing substitution volume in daily clinical practice
Convective volume
Haemo-concentration
Page 14EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
Cardioprotective Haemodialysis
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
Changing the perspective is the key for more performance
Page 15
Dynamic Signal analysis
of pressure pulses-> along the blood
flow pathway
New
+
StaticTransmembran
Pressure
Today
P
P
P
TMP
P
Cardioprotective Haemodialysis
Functional principle of AutoSub plus
Optimal Performance = highest substitution rate at any time
Changing conditions along the blood flow pathway
of the dialyzer (e.g. flow conditions due to haemoconcentration)
Dynamic Signal Analysis of Pressure Pulses
Permanent measuring & evaluating of conditions along the blood flow pathway
in the dialyzer
Autoregulation Immediate adaptation
(up or down) of substitution rate to the
current treatment conditions
Detected by
Triggers
Leading to
P
P
P
TMP
P
+
1
2
3
4
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013 Page 16
Cardioprotective Haemodialysis
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
Milestone 2: AutoSub plus in 5008 CorDiax*
Objective: Automatic maximisation of substitution rate for alarm-free treatment
Very precise information on the conditions in the dialyser is available
- not just across the membrane but also along the blood flow pathway.
Several checks per minute
enable the continuous optimization of the substitution rates (decrease & increase).
The system is automatically activated at start of treatment
Page 17
Measurement + automatic adaptation (up or down)
Dynamic analysis of pressure pulses along the blood flow
pathway!
5008 CorDiax5008S CorDiax
Sub volume is individually maximised resulting in higher filtration fraction
Cardioprotective Haemodialysis
Each Increase in Filtration Fraction pays off
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013 Page 18
15% 20% 25% 30%10
15
20
25
30
Achievable substitution volume at different blood flows and filtration fraction
Qb [ml/min] 275 Qb [ml/min] 320 Qb [ml/min] 385
Filtration Fraction [%]
Su
bsti
tuti
on
Volu
me [
L/ 4 h
r sessio
n]
Target Sub Volume = 21 L
Cardioprotective Haemodialysis
Achieving high volumes is also a matter of using technology designed for HighVolumeHDF
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013 Page 19
Setting of sub rate
Calculation + automatic decrease of sub rate
Measurement + automatic adaptation (up or down) of
sub rate
Manual
volume control
AutoSub AutoSub plus
PAST TODAY
New
4008
Dynamic analysis of pressure pulses along the blood flow
pathway!
Cardioprotective Haemodialysis
Suitable dialyser for HighVolumeHDF
Increased inner fibre lumen of the FX CorDiax HDF dialysers
facilitates optimal flow conditions for maximal performance
The new Helixone®plus membraneof the FX CorDiax series
improves the removal of middle molecules while ensuring the retention of albumin
FX CorDiax 600 FX 600
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013 Page 20
Cardioprotective Haemodialysis
Achieving adequate substitution volumes* is facilitated by using the right technology
AutoSub plus - Automatic maximisation of substitution volume in HighVolumeHDF
FX CorDiax HDF dialysers- facilitate optimal flow conditions for maximal performance - improve the removal of middle molecules while ensuring
the retention of albumin
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013 Page 21
* (>21 L / session)
In combination with FX CorDiax HDF dialysers, AutoSub plus maximizes substitution volumes in
post-dilution HDF in a highly safe manner compared to conventional methods.
Cardioprotective Haemodialysis
The right technology for HighVolumeHDF -Benefits of AutoSub plus
The fully automatic regulation means no additional work for the nurses: neither in setting the right pump speed nor in assuring trouble-free treatment.
In daily routine this comes down to a safe and simple application of HighVolumeHDF for a large number of patients.
AutoSub plus supports the nephrologist to prescribe high substitution volumes even with „average“ blood flows.
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013 Page 22
More patients will be able to reach high substitution volumes and benefit from the positive outcomes of
HighVolumeHDF.
Cardioprotective Haemodialysis
Thank you
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013 Page 23