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WAA registry data of LDLapheresis and concepts of how to enable a comparison with a control group

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... trends over time. Improve safety and quality of therapy. WAA Registry ... Both groups with optimal conventional therapy. As new study or as historical control ... – PowerPoint PPT presentation

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Title: WAA registry data of LDLapheresis and concepts of how to enable a comparison with a control group


1
WAA registry data of LDL-apheresis and concepts
of how to enable a comparison with a control group
  • Dr. med. Heinrich Prophet
  • Dialysegemeinschaft Nord, Apheresezentrum
    Rostock, Deutschland

2
WAA Registry
  • Why ?
  • Visualize apheresis activity and bundle efforts
    in this field.
  • Recognize indications, techniques, side effects
    and outcomes.
  • Compare those modalities nationally and
    internationally.
  • Follow apheresis trends over time.
  • Improve safety and quality of therapy.

3
WAA Registry
  • Features
  • Specific coding of center and patient
  • No expenses for the collaborating center
  • Non-competitive evaluation
  • Single or multi center studies are feasable

4
WAA Registry
  • Participants (march 08)
  • 75 centers applied for a login code
  • 15 centers in 7 countries enter actively
  • 2013 patients with 12448 procedures have been
    submitted

5
WAA Registry LDL apheresis fraction
  • Participants (august 2008)
  • 6 centers in 4 countries (Sweden, Lithuania,
    Czech Republic, Germany) have entered
    LDL-apheresis procedures
  • 53 patients with 2740 procedures have been
    submitted

6
WAA Registry LDL apheresis fraction
  • Participants (august 2008)

7
WAA Registry LDL apheresis fraction
  • Participants (august 2008)

8
WAA Registry LDL apheresis fraction
  • Patients characteristics (august 2008)
  • mean age 50,2 years (10-76)
  • gender distribution 31 men 22 women
    (58,541,5 )

9
WAA Registry LDL apheresis fraction
  • Patients characteristics (august 2008)
  • Diseases leading to LDL-apheresis

10
WAA Registry LDL apheresis fraction
  • Patients characteristics (august 2008)
  • Blood access for chronic LDL-apheresis

11
WAA Registry LDL apheresis fraction
  • Treatment characteristics (august 2008)
  • Devices used for direct adsorption/primary
    separation

12
WAA Registry LDL apheresis fraction
  • Treatment characteristics (august 2008)
  • Devices used for plasma treatment

13
WAA Registry LDL apheresis fraction
  • Treatment characteristics (august 2008)
  • Anticoagulation

14
WAA Registry LDL apheresis fraction
  • Outcomes (august 2008)
  • VAS of functional ability
  • In only 803 of 2696 therapies submitted (29,8 )

15
WAA Registry LDL apheresis fraction
  • Outcomes (august 2008)
  • VAS of quality of life
  • In only 248 of 2696 therapies submitted (9,2 )

16
WAA Registry LDL apheresis fraction
  • Outcomes (Center Rostock, august 2008)
  • All cardiovascular events (MI, PCI, coronary or
    peripheral bypass) in 29 LDL-apheresis patients
    of the Rostock Apheresis Center before and after
    start of apheresis

plt0,001

17
WAA Registry LDL apheresis fraction
  • Outcomes (Center Rostock, august 2008)
  • All cardiovascular events (MI, PCI, coronary or
    peripheral bypass) in 29 LDL-apheresis patients
    of the Rostock Apheresis Center before and after
    start of apheresis

n29
18
WAA Registry LDL apheresis fraction
  • Adverse events (august 2008)
  • In 2740 sessions only 115 adverse events were
    stated (4,2 )

n115
19
WAA Registry LDL apheresis fraction
  • Adverse events (august 2008)
  • Women show more side effects than men

p0,014

20
WAA Registry LDL apheresis fraction
  • Adverse events (august 2008)
  • Women drop off more frequent than men

p0,012

21
WAA Registry LDL apheresis a concept to
compare outcomes with a control group
  • Problems
  • Small group of patients with LDL-apheresis
  • Only few countries with reimbursement
  • Ethical concerns with an apheresis sham group in
    this high risk population

22
WAA Registry LDL apheresis a concept to
compare oucomes with a control group
  • Proposal for a solution
  • International control group with patients
    actually showing the indication for apheresis in
    countries where therapy is not available
  • Both groups with optimal conventional therapy
  • As new study or as historical control
  • (e.g. with established databases)

23
WAA Registry LDL apheresis fraction Conclusions
  • Conclusion I
  • WAA registry LDL fraction is still
  • relatively small
  • Yet the submitted data gives information about
    modalities, quality und results of LDL-apheresis
    therapy in different countries (so far only
    Europe)

24
WAA Registry LDL apheresis fraction Conclusions
  • Conclusion II
  • Number of patients per center differs
    considerably
  • Men are more frequent treated than women
  • Diagnoses leading to apheresis are rather
    unspecific
  • Peripheral access is mostly used
  • Prevailing techniques DALI and Octo (MDF)
  • (eg) Citrate is the leading anticoagulant

25
WAA Registry LDL apheresis fraction Conclusions
  • Conclusion III
  • LDL-apheresis is well tolerated
  • Women show more side effects and drop off more
    often than men
  • Patients show a good quality of life and a rather
    good functional ability under LDL-apheresis
  • Cardiovascular events are clearly reduced
    (Rostock, and personal information from Prague)
  • Studies are needed to prove this in general
  • A control group could include maximally but not
    sufficiently treated patients with no access to
    LDL-apheresis or historical controls
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