1. H.E.L.P. LDL-apheresis clinical experience in Italy1
H.E.L.P. LDL-apheresis clinical experience in Italy
Stefanutti C, Di Giacomo S, Shafii M, Morozzi C, Mazzilli S,
and the Italian Multicenter Study (IMS) LDL-apheresis (LDLa) Working Group
ISFA Vienna 2011
8th International Society for Apheresis Congress
September 14th – 17th
University Hospital, Vienna - Austria
Lake of Bracciano, NW Rome, September 2011

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Background and aims
The clinical benefits of LDL-apheresis (LDL-A) have been demonstrated in:
the H.E.L.P. LDL-A Multicenter Study
the LDL-A Atherosclerosis Regression Study (LAARS)
the German Multicenter LDL-A Trial
the FH Regression Study.
The efficacy and safety of the heparin-induced extra-corporeal LDL-precipitation (H.E.L.P.®) LDL–A on long-term, has been studied in a single center (Rome, “La Sapienza” University) open retrospective survey.
Furthermore, the increasing use of H.E.L.P. LDL-A in Italy was recently reported also by the coordination (Rome) of the Italian Multicenter Study on LDL-apheresis Working Group (unpublished data).

3. The data from 22 (♂ 13 - ♀ 9) patients were evaluated
accounting for 1437 H.E.L.P. LDL-A sessions.
The Plasmat™ Futura System is used
selectively to remove apoprotein B100-containing-
lipoproteins in patients with severe dyslipidemia
in our center.
Regular treatment with H.E.L.P. LDL-A was
administered weekly or biweekly in Hoz
and Htz FH patients.
Vascular accesses: antecubital veins
Plasma volume treated per session: 3000 ml 3
Patients and Methods

4. Patients Age Dyslipidemia CAD and/or AVD Activity parameters
♂: 13 ♀: 9
Age
X: SD: 15.4
Dyslipidemia
Homozygous-Compound FH: Heterozygous FH: 12
CAD and/or AVD
77.2 %(documented by angiography)
Activity parameters
Homozygous FH
mg/dL
X SD
Heterozygous FH
X SD
LDL-Chol
before
after
402
148 85 34
388
138 56 20
HDL-Chol 50 41 7 8 45 36 6
Lp(a) 19 3 31 12 14
Fibrinogen
224 80 54 21
315
134 46 32 4 4 4

5. SASSARI
OZIERI
NUORO
CAGLIARI
PALERMO
BARI
L’AQUILA
ROMA
PISTOIA
REGGIO EMILIA
GALLARATE
MILANO
PADOVA
TRIESTE
VERONA
VITERBO
PRATO
FORLÌ 5
Coordinating
centre
Italian Multicenter Study on LDL-apheresis Working Group (# 23 Centers) 5

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8. Total patients under treatment in Italy: # 2118
IMSLDLa-WG: # 157
Not belonging: # 54
Total patients under treatment in Italy: # 211

9. 27 62 IMS LDLa 2011 (2009 activity; # 18 Centers; # 101 patients) MPVT
MBVT
MPVS
3127 ± 518.5
(1700 vs 4000 ml) ±
(5000 vs ml)
3500 ± 300
(3200 vs 3800 ml)
Major side effects
(# total events)
Minor side effects
(# total events) 27 62
IMSLDLa-WP:# 101 Patients under treatment (2009)

10. Symptomatic Hypocalcemia 8 Hematoma by venipuncture 230 10
Italian Multicenter Study on Low-Density Lipoprotein Apheresis (IMS-LDLa): Side effects and number of events (2007)
IMS-LDLa Centers = 18
Side effects No. of events
Symptomatic Hypocalcemia
Hematoma by venipuncture
Low outlet flow
Circuit coagulation
Allergic reaction
Gastrointestinal discomfort/vomiting
Fever and shivers
Hypotension/collapse
Vasovagal reaction
Hemolysis
Cardiac arrhythmias
Stefanutti C and the Italian Multicenter Study (IMS) on LDL-apheresis (LDLa) Working Group (2010):
The Italian Multicenter Study on LDL-apheresis: retrospective analysis (2007)
Ther Apher Dial. 14(1):79-86.

11. IMSLDLa-WG Survey 2009, unpublished11
IMSLDLa-WG Survey 2009, unpublished

12. IMSLDLa-WG Survey 2009, unpublished12
IMSLDLa-WG Survey 2009, unpublished

13. IMSLDLa-WG Survey 2009, unpublished13
IMSLDLa-WG Survey 2009, unpublished

14. Results and Discussion14
Results and Discussion
The 2nd survey of the IMSLDLa-WG was carried out. The study involved 18 centres for LDL-A. The patients enrolled in 2009 were 101 (66 males; 35 females) aged 47 ± 18 years.
The average age for initial drug treatment before LDL-A was 31 ± 18 years. The mean age to the 1st LDL-A was 37 ± 20 years. The average duration of treatment was 9 ± 6 years.
The techniques utilized were: HELP, DALI, DSC, PEX, CF.
The mean treated plasma and blood volumes/session were 3127 ± 518 mL and 8666 ± 1384 mL, respectively. The average plasma volume substituted was 3500 ± 300 mL.
The hypolipidemic drugs given before LDL-A were: ezetimibe+simvastatin, atorvastatin, rosuvastatin, ω-3 fatty acids, and fenofibrate.

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Conclusion
Interestingly, ischemic events were not observed in patients with CAD, and without CAD treated with all LDL-A and LA techniques because of refractoriness or intolerance to drugs, over 9 ± 6 years treatment.
H.E.L.P. LDL-A treatment was beneficial and safe in patients with refractory hypercholesterolemia genetically determined, CAD.
The increasing use of H.E.L.P. LDL-A in Italy was recently reported also by the coordination (Rome) of the Italian Multicenter Study on LDL-apheresis Working Group (unpublished data). Among 101 patients submitted to LDL-A in 18 Italian centers, 41 have been treated with H.E.L.P. LDL-A.

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Take-home message
The Italian Multicenter Study on LDL-apheresis Working Group
This group is the organizational and operative forum where experts in LDL-A and LA in our country collaborate on clinical, technical, scientific and experimental themes. Concerning the guidelines, the group has decided to develop a common protocol of orientation, also specialized in updating and training, that could be extended to new centers that desire to join the network.
The II Italian Consensus Conference on LDL-apheresis (2009) was made possible by the collaborating centers belonging to the above mentioned group.
Stefanutti C (2010): The nd Italian Consensus Conference on LDL-apheresis Nutrition, Metabolism & Cardiovascular Diseases. 20(10)

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References