From complex dream to simple reality:
HighVolumeHDF – the standard therapy of
the future. NOW!
How Technological Developments
make better Treatment a Reality
Angelika Kneppel
Fresenius Medical Care, Germany
EDTNA Corporate Education Session
Malmö, Sept. 1st, 2013
Cardioprotective Haemodialysis
The new Catalonian HighVolumeHDF study shows:
HighVolumeHDF improves patient survival
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)
Better patient well-being
28%
risk reduction in incidence of
hypotensive episodes (p<0.001)
Reduced treatment costs
22%
risk reduction in all-cause
hospitalisation (p=0.001)
Randomized controlled clinical
trial with positive primary
outcome!
Maduell F et al, J Am Soc Nephrol. 24 (2013)
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
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.
ONLINE was a technology for water preparation,
HighVolumeHDF is THE therapy approach.
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
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
ONLINEplus – Double-stage filtration system
Automated integrity test
Reverse
Osmosis
(RO)
Ready-made
concentrate
fluid
Unlimited
sterile, non-pyrogenic
substitution fluid
Dialysis fluid
1
ISO 13959:2009
2
ISO 23500:2011
* Local regulations may differ
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care
Sept 2013
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Cardioprotective Haemodialysis
The Catalonian HighVolumeHDF study
is part of a bigger picture…
Catalonian HighVolumeHDF
Study (2013):
30% Risk reduction in all-cause
mortality vs. high-flux HD (p=0.01)
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)
All have one in common
(*High efficiency = Sub. volume > 21L)
Contrast (2012):
– Volume matters!
Turkish (2011):
High-volume HDF* considerably
reduces mortality risk compared
to low-flux HD (p=0.003)
(*High-volume ≥21.95 L)
HDF treatment with substitution
volume › 17.4 L provides better
cardiovascular and overall survival
compared to high-flux HD (p=0.03)
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
Volume matters –
but how much is high-volume?
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
Volume matters –
but how much is high-volume?
Total convective volume
per treatment1
~ 23 L
Objective of HighVolumeHDF:
Vsub ≥ 21 L in postdilution
Substitution volume
21 L
Weight loss
~2L
Delivered median volumes
based on Maduell F. et al. 2013
1
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
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
Achieving high substitution volume
- blood flow limits the performance
Performance limits in post-dilution HDF
blood
outlet
blood
inlet
Filterable
plasma water
Rule of thumb
– Filtration Fraction [FF]
QUF
Qspost
Protein/
Protein
bound water
(schematic diagram)
~ 25% QB
Example:
Haematocrit
QB
= 320 mL/min
FF
= 25 %
 Qcon
QB
QB = Blood flow rate ; Qcon = convective flow rate
Qspost = Substitution flow rate in post-dilution mode;
QUF = Ultrafiltration rate (weight loss);
FF = Filtration Fraction; Vsub = Substitution volume;
QUF
= 80 mL/min
= 10 ml/min
 Qspost = 70 mL/min
 Vsub
= 17 L
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
Crucial factors for HighVolumeHDF therapy
- it is not just a matter of blood flow …
5008S CorDiax & 5008 CorDiax
• AutoSub plus
• MIXED HDF
Patient related:
High effective
blood flow
Good
rheological
conditions
Therapy driven:
+
Convective dose
(= max. substitution)
+
+
+
FX CorDiax HDF
Optimal
filtration flow
+
+
Treatment time
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
Achieving high volumes is also a matter of using
technology designed for HighVolumeHDF
How to set-up the substitution volume?
TODAY
PAST
4008 H
ONLINEplus®
“Advanced online
Preparation with
DIASAFE®plus”
5008
Therapy System
“Online haemodiafiltration
as standard treatment”
5008 CorDiax &
5008S CorDiax
“With AutoSub plus HighVolumeHDF
becomes as simple and safe as HD”
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
Starting point:
Haemodiafiltration with manual volume control
Requires manual calculation, setting & adaptation
of the substitution rate during the treatment
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
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
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
Calculation and
automatic decrease of
substitution rate
 Sub volumes tend to be lower than possible
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
Milestone 2: AutoSub plus in 5008 CorDiax*
Objective: Automatic maximisation of
substitution rate for alarm-free treatment
5008 CorDiax
5008S CorDiax
* and 5008S CorDiax
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
The challenge of HighVolumeHDF:
Maximizing substitution volume in daily clinical practice
Haemoconcentration
Convective
volume
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
Changing the perspective
is the key for more performance
Dynamic
Signal analysis
of pressure pulses
Static
Transmembran
Pressure
P
P
+
-> along the blood
flow pathway
TMP
P
P
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
Functional principle of AutoSub plus
4
Optimal Performance
= highest substitution rate at any time
Leading to
3 Autoregulation
1
Immediate adaptation
(up or down) of
substitution rate to the
current treatment
conditions
Triggers
2
P
+
TMP
P
Changing
conditions along the
blood flow pathway
of the dialyzer
P
(e.g. flow conditions due
to haemoconcentration)
P
Dynamic Signal Analysis
of Pressure Pulses
Permanent measuring & evaluating
of conditions along the blood flow pathway
in the dialyzer
Detected
by
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
Milestone 2: AutoSub plus in 5008 CorDiax*
Objective: Automatic maximisation of
substitution rate for alarm-free treatment
5008 CorDiax
5008S CorDiax
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).
Dynamic analysis of pressure
pulses along the blood flow
pathway!
The system is automatically activated
at start of treatment
Measurement + automatic
adaptation (up or down)
 Sub volume is individually maximised
resulting in higher filtration fraction
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
Each Increase in Filtration Fraction pays off
Substitution Volume [L/ 4 hr session]
30
Achievable substitution volume
at different blood flows and filtration fraction
25
Target Sub Volume = 21 L
20
15
10
15%
20%
25%
30%
Filtration Fraction [%]
Qb [ml/min] 275
Qb [ml/min] 320
Qb [ml/min] 385
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
Achieving high volumes is also a matter of using
technology designed for HighVolumeHDF
TODAY
PAST
Manual
AutoSub
AutoSub plus
volume control
4008
Dynamic analysis of pressure
pulses along the blood flow
pathway!
Setting
of sub rate
Calculation + automatic
decrease of sub rate
Measurement + automatic
adaptation (up or down) of
sub rate
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
Suitable dialyser for HighVolumeHDF
The new Helixone®plus membrane
of the FX CorDiax series
Increased inner fibre lumen of the
FX CorDiax HDF dialysers
improves the removal of middle
molecules while ensuring
the retention of albumin
facilitates optimal flow conditions for
maximal performance
FX CorDiax 600
FX 600
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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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
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.
* (>21 L / session)
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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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.
More patients will be able to reach high substitution
volumes and benefit from the positive outcomes of
HighVolumeHDF.
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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Cardioprotective Haemodialysis
Thank you
EDTNA CES HighVolumeHDF - © Copyright Fresenius Medical Care Sept 2013
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