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 (58,5:41,5 %)

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 * * p<0,001

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 n=29

18. WAA Registry – LDL apheresis fraction Adverse events (august 2008) :  In 2740 sessions only 115 adverse events were stated (4,2 %) n=115

19. WAA Registry – LDL apheresis fraction Adverse events (august 2008) :  Women show more side effects than men * p=0,014 *

20. WAA Registry – LDL apheresis fraction Adverse events (august 2008) :  Women drop off more frequent than men * p=0,012 *

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