waa registry data of ldl- apheresis and concepts of how to enable a comparison with a control group...
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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.
WAA RegistryWAA Registry
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
WAA RegistryWAA Registry
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
WAA Registry – LDL apheresis WAA Registry – LDL apheresis fractionfraction
Participants Participants (august 2008)(august 2008)::
6
27
1
19
0
5
10
15
20
25
30
Czech Rep. Germany Lithuania Sweden
Number of patients
WAA Registry – LDL apheresis WAA Registry – LDL apheresis fractionfraction
Participants Participants (august 2008)(august 2008)::
0
1
2
3
4
Czech Rep. Germany Lithuania Sweden
Number of centers
WAA Registry – LDL apheresis WAA Registry – LDL apheresis fractionfraction
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 %)
WAA Registry – LDL apheresis WAA Registry – LDL apheresis fractionfraction
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 (%)
WAA Registry – LDL apheresis WAA Registry – LDL apheresis fractionfraction
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 %
WAA Registry – LDL apheresis WAA Registry – LDL apheresis fractionfraction
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 %
WAA Registry – LDL apheresis WAA Registry – LDL apheresis fractionfraction
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 %
WAA Registry – LDL apheresis WAA Registry – LDL apheresis fractionfraction
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 %
WAA Registry – LDL apheresis WAA Registry – LDL apheresis fractionfraction
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
WAA Registry – LDL apheresis WAA Registry – LDL apheresis fractionfraction
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
WAA Registry – LDL apheresis WAA Registry – LDL apheresis fractionfraction
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
WAA Registry – LDL apheresis WAA Registry – LDL apheresis fractionfraction
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
WAA Registry – LDL apheresis WAA Registry – LDL apheresis fractionfraction
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
WAA Registry – LDL apheresis WAA Registry – LDL apheresis fractionfraction
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
*
WAA Registry – LDL apheresis WAA Registry – LDL apheresis fractionfraction
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)
WAA Registry LDL apheresis fraction – WAA Registry LDL apheresis fraction –
ConclusionsConclusions
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
WAA Registry LDL apheresis fraction – WAA Registry LDL apheresis fraction –
ConclusionsConclusions
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