WAA registry data of LDL- apheresis and concepts of how to enable a comparison with a control group Dr. med. Heinrich Prophet Dialysegemeinschaft Nord,

WAA registry data of LDL-WAA registry data of LDL-apheresis and concepts of how to apheresis and concepts of how to

enable a comparison with a enable a comparison with a control groupcontrol group

Dr. med. Heinrich ProphetDr. med. Heinrich Prophet

Dialysegemeinschaft Nord, Apheresezentrum Rostock, Dialysegemeinschaft Nord, Apheresezentrum Rostock, DeutschlandDeutschland

WAA RegistryWAA Registry

Why ?Why ?

Visualize apheresis activity and bundle Visualize apheresis activity and bundle efforts in this field.efforts in this field.

Recognize indications, techniques, side Recognize indications, techniques, side effects and outcomes.effects and outcomes.

Compare those modalities nationally and Compare those modalities nationally and internationally.internationally.

Follow apheresis trends over time.Follow apheresis trends over time. Improve safety and quality of therapy.Improve safety and quality of therapy.


Features:Features:

Specific coding of center and patientSpecific coding of center and patient

No expenses for the collaborating centerNo expenses for the collaborating center

Non-competitive evaluation Non-competitive evaluation

Single or multi center studies are feasable Single or multi center studies are feasable


Participants Participants (march 08)(march 08)::

75 centers applied for a login code75 centers applied for a login code

15 centers in 7 countries enter actively 15 centers in 7 countries enter actively

2013 patients with 12448 procedures have 2013 patients with 12448 procedures have been submitted been submitted

WAA Registry – LDL apheresis WAA Registry – LDL apheresis fractionfraction

Participants Participants (august 2008)(august 2008)::

6 centers in 4 countries (6 centers in 4 countries (Sweden, Lithuania, Sweden, Lithuania,

Czech Republic, GermanyCzech Republic, Germany) have entered LDL-) have entered LDL-apheresis procedures apheresis procedures

53 patients with 2740 procedures have been 53 patients with 2740 procedures have been submittedsubmitted



6

27

1

19

0

5

10

15

20

25

30

Czech Rep. Germany Lithuania Sweden

Number of patients



0

1

2

3

4

Czech Rep. Germany Lithuania Sweden

Number of centers


Patients characteristics Patients characteristics (august 2008)(august 2008) : :

mean age: 50,2 years (10-76) mean age: 50,2 years (10-76)

gender distribution: 31 men : 22 women gender distribution: 31 men : 22 women (58,5:41,5 %)(58,5:41,5 %)


Patients characteristics Patients characteristics (august 2008)(august 2008) : : Diseases leading to LDL-apheresisDiseases leading to LDL-apheresis

45,350,9

3,8

0

10

20

30

40

50

60

Hypercholesterolemia Hyperlipidemia (unspecific) Lipid metabolism disorder(unspecific)

Reason for LDL-apheresis (%)


Patients characteristics Patients characteristics (august 2008)(august 2008) : : Blood access for chronic LDL-apheresis:Blood access for chronic LDL-apheresis:

79,2

3,87,5

3,8 3,8

0

10

20

30

40

50

60

70

80

90

peripheral vein jugular vein AV-fistula AV-graft other

Blood access %


Treatment characteristics Treatment characteristics (august 2008)(august 2008) : : Devices used for direct adsorption/primary separation

0

10

20

30

40

50

60

Octo Nova Cobe Spectra Life 18 HELP DALI Kaneka DX

Applied devices %


Treatment characteristics Treatment characteristics (august 2008)(august 2008) : : Devices used for plasma treatmentDevices used for plasma treatment

0

10

20

30

40

50

60

70

80

90

100

One device ADA Medicap Other

Applied devices %


Treatment characteristics Treatment characteristics (august 2008)(august 2008) : : AnticoagulationAnticoagulation

5,7

67,6

51,5 0,2

16,8

3,1

0

10

20

30

40

50

60

70

80

no comment ACD ACD + LMW ACD +Heparin

Citrate Heparin other

Anticoagulation %


Outcomes Outcomes (august 2008)(august 2008) : : VAS of functional abilityVAS of functional ability In only 803 of 2696 therapies submitted (29,8 %)In only 803 of 2696 therapies submitted (29,8 %)

0

100

200

300

400

500

600

4 5 6 7 8 9 10

VAS Functional ability

Counts


Outcomes Outcomes (august 2008)(august 2008) : : VAS of quality of lifeVAS of quality of life In only 248 of 2696 therapies submitted (9,2 %)In only 248 of 2696 therapies submitted (9,2 %)

0

20

40

60

80

100

120

140

160

6 7 8 9 10VAS quality of life

Counts


Outcomes Outcomes (Center Rostock, august 2008)(Center Rostock, august 2008) : : All cardiovascular events (MI, PCI, coronary or peripheral All cardiovascular events (MI, PCI, coronary or peripheral

bypass) in 29 LDL-apheresis patients of the Rostock bypass) in 29 LDL-apheresis patients of the Rostock Apheresis Center before and after start of apheresisApheresis Center before and after start of apheresis

66

22

0

10

20

30

40

50

60

70

Before After

Events

*

* p<0,001


Outcomes Outcomes (Center Rostock, august 2008)(Center Rostock, august 2008) : : All cardiovascular events (MI, PCI, coronary or peripheral All cardiovascular events (MI, PCI, coronary or peripheral

bypass) in 29 LDL-apheresis patients of the Rostock bypass) in 29 LDL-apheresis patients of the Rostock Apheresis Center before and after start of apheresisApheresis Center before and after start of apheresis

0

10

20

30

40

50

60

70

Before After

CV events Pat.29Pat.28Pat.27Pat.26Pat.25Pat.24Pat.23Pat.22Pat.21Pat.20Pat.19Pat.18Pat.17Pat.16Pat.15Pat.14Pat.13Pat.12Pat.11Pat.10Pat.9Pat.8Pat.7Pat.6Pat.5Pat.4Pat.3Pat.2Pat.1

n=29


Adverse events Adverse events (august 2008)(august 2008) : : In 2740 sessions only 115 adverse events were In 2740 sessions only 115 adverse events were

stated (4,2 %)stated (4,2 %)

0 5 10 15 20 25 30

New puncture

Hypotension

Access other

Technical other

Abdominal pain

Technical-device misfunction

Technical-coagulation in tubing

Hypertension

Phlebitis

Access angiospasm

Nausea

Flush

Prolonged bleeding after

% of AEs

n=115


Adverse events Adverse events (august 2008)(august 2008) : : Women show more side effects than menWomen show more side effects than men

3,58

5,65

0,00

1,00

2,00

3,00

4,00

5,00

6,00

Men Women

Adverse events % * p=0,014

*


Adverse events Adverse events (august 2008)(august 2008) : : Women drop off more frequent than menWomen drop off more frequent than men

2,23

3,95

0

0,5

1

1,5

2

2,5

3

3,5

4

4,5

Men Women

Drop off %

* p=0,012

*

WAA Registry LDL apheresis – WAA Registry LDL apheresis – a concept to compare outcomes with a a concept to compare outcomes with a

control groupcontrol group

Problems: Problems:

Small group of patients with LDL-apheresisSmall group of patients with LDL-apheresis

Only few countries with reimbursementOnly few countries with reimbursement

Ethical concerns with an apheresis sham Ethical concerns with an apheresis sham group in this high risk populationgroup in this high risk population

WAA Registry LDL apheresis – WAA Registry LDL apheresis – a concept to compare oucomes with a a concept to compare oucomes with a

control groupcontrol group

Proposal for a solution: Proposal for a solution:

International control group with patients International control group with patients actually showing the indication for apheresis actually showing the indication for apheresis in countries where therapy is not availablein countries where therapy is not available

Both groups with optimal conventional Both groups with optimal conventional therapytherapy

As new study or as historical control As new study or as historical control (e.g. with established databases)(e.g. with established databases)

WAA Registry LDL apheresis fraction – WAA Registry LDL apheresis fraction –

ConclusionsConclusions

Conclusion I: Conclusion I:

WAA registry LDL fraction is still WAA registry LDL fraction is still relatively smallrelatively small

Yet the submitted data gives information Yet the submitted data gives information about modalities, quality und results of about modalities, quality und results of LDL-apheresis therapy in different LDL-apheresis therapy in different countries (so far only Europe)countries (so far only Europe)



Conclusion II: Conclusion II: Number of patients per center differs considerablyNumber of patients per center differs considerablyMen are more frequent treated than womenMen are more frequent treated than womenDiagnoses leading to apheresis are rather Diagnoses leading to apheresis are rather

unspecificunspecificPeripheral access is mostly used Peripheral access is mostly used Prevailing techniques: DALI and Octo (MDF)Prevailing techniques: DALI and Octo (MDF) (eg) Citrate is the leading anticoagulant(eg) Citrate is the leading anticoagulant



Conclusion III: Conclusion III: LDL-apheresis is well toleratedLDL-apheresis is well tolerated Women show more side effects and drop off Women show more side effects and drop off

more often than menmore often than men Patients show a good quality of life and a rather Patients show a good quality of life and a rather

good functional ability under LDL-apheresisgood functional ability under LDL-apheresis Cardiovascular events are clearly reduced Cardiovascular events are clearly reduced

(Rostock, and personal information from Prague)(Rostock, and personal information from Prague) Studies are needed to prove this in generalStudies are needed to prove this in general A control group could include maximally but not A control group could include maximally but not

sufficiently treated patients with no access to sufficiently treated patients with no access to LDL-apheresis or historical controlsLDL-apheresis or historical controls

WAA registry data of LDL- apheresis and concepts of how to enable a comparison with a control group Dr. med. Heinrich Prophet Dialysegemeinschaft Nord,

Documents

ldlapheresis slide

ldlapheresis patients

ldl apheresis procedures

chronic ldlapheresis

waa registry data of

waa registry participants

waa registry features

apheresis activity