From complex dream to simple reality: HighVolumeHDF – the standard therapy of the future. NOW! How...

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

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)



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.



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

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


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)

(*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!


Volume matters – but how much is high-volume?



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?


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


blood inlet

blood outlet

Achieving high substitution volume - blood flow limits the performance


~ 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;


Therapy driven:Patient related:

+

+

Crucial factors for HighVolumeHDF therapy- it is not just a matter of blood flow …


+

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

+


Achieving high volumes is also a matter of using technology designed for HighVolumeHDF


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?


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



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 andautomatic decrease of

substitution rate

Sub volumes tend to be lower than possible



Milestone 2: AutoSub plus in 5008 CorDiax*

Objective: Automatic maximisation of substitution rate for alarm-free treatment

5008 CorDiax5008S CorDiax

* and 5008S CorDiax


The challenge of HighVolumeHDF: Maximizing substitution volume in daily clinical practice

Convective volume

Haemo-concentration




Changing the perspective is the key for more performance

Dynamic Signal analysis

of pressure pulses-> along the blood

flow pathway

New

+

StaticTransmembran

Pressure

Today

P

P

P

TMP

P


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




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

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


Each Increase in Filtration Fraction pays off


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


Achieving high volumes is also a matter of using technology designed for HighVolumeHDF


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!


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



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


* (>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.


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.


Thank you


From complex dream to simple reality: HighVolumeHDF – the standard therapy of the future. NOW! How...

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