Efficiency and Performances of Double. Journées d Automne de la SFH 25 novembre 2011

Transcription

1 Efficiency and Performances of Double Column Whole Blood (DCW) LDL-Apheresis O.Hequet 1, QH Le 2, S Jaeger 1, A Remenant 1, D Revesz 1, A Kassir 1, M Cellot 1, D Bessard 1, MP Aubert 1, D Rigal 1, A Sassolas 3, L Groisne 4, P Moulin 4 1 Apheresis Unit, Etablissement Français du Sang, Lyon, France 2 Statistical Unit, Hospices Civils de Lyon (HCL), Lyon, France 3 Laboratory of Lipids, HCL, Lyon, France 4 Endocrinology Unit, HCL, Lyon, France Journées d Automne de la SFH 25 novembre 2011

2 Purposes Diet and oral medications non sufficient in FH LDL-Aph is used for the patients with higher levels and Statins side effects Oldest LDL-aph methods : plasma separation from blood and then LDL-adsorption in plasma Whole blood extraction procedures Two consecutive liposorbers Machine MA x BV + 1 L Citrate dextrose: 2.5 %

3 LIPOSORBER SYSTEM

4 LIPOSORBER SYSTEM Diet Therapy Diet & Drug Therapy LIPOSORBER Treatment Pre Time Average Post Time

5 Methods Cholesterol extraction assessment Before LDL-aph TC HDL-C TG Lp(a) Apo-B After LDL-aph TC HDL-C TG Lp(a) Apo-B Acute reductions (%) = 100 x (Cpre-Cpost)/Cpre Corrected concentration (Corr.Cpost) = measured value x (1- Hct post )/(1-Hct pre ) x Hct pre / Hct post Corrected Acute reduction (%) = 100 x (Cpre-corr.Cpost)/Cpre Uncorrected acute reductions rates Variability and repeated measures in each patient : linear mixed effects model using patients as a random effect Clinical tolerance and side effects Allergic or pseudoallergic complications Arterial tension

6 Characteristics of the patients Sex Age FH Status Frequency of TC LDL-apheresis H 68 HT Every 3 weeks 262 H 38 HM Biweekly 222 F 42 HT Biweekly 309 H 69 FCH Biweekly 389 H 44 HT Biweekly 292 H 35 HT Biweekly 249 H 70 double HT Biweekly 291 F 44 HT Biweekly 326 H 31 double HT Biweekly 360 H 59 double HT Biweekly 370 H 17 double HT Biweekly 366 F 13 double HT Biweekly 336 F 54 HT Biweekly 320 F 53 FCH Biweekly 293 F 55 HT Biweekly 483 H 54 HT Biweekly HT, heterozygous; HM, homozygous; FCH, combined hyperlipidemia HDL-C Apo-B

7 Initial performances in 12 patients Preapheresis mean +/- SD Postapheresis mean +/- SD Reductions (%) Number of sessions TC 319 +/ / / / / / HDL-C 42 +/ / / TG 177 +/ / / Lp(a) 81 +/ / / Apo-B 182 +/ / /

8 Updated performances in 16 patients Parameter Preapheresis mean +/- SD Postapheresis mean +/- SD Reductions (%) Number of sessions TC 323 +/ / / / / / HDL-C 42 +/ / / TG 125 +/ / / Lp(a) 81 +/ / / Apo-B 178 +/ / /

9 Comparison of lipid acute reductions rates in double- (DL-50 x 2) or single-column (DL-75) WB procedure 10 patients : 1.6 x BV + 1 L : 1.6 x BV + 1 L Pre-apheresis mean +/- SD (mg/l) Post-apheresis mean +/- SD (mg/l) TC 305 +/ / / / Acute reductions (%) n=152 n= / /- 5.7 p< / / / / / /- 5.0 p< HDL-C 41 +/ / / / / /- 6.6 p< TG 227 +/ / / / / /- 17 p=0. 10 Lp(a) 81 +/ / / / / /- 3.9 Apo-B 172 +/ / / / / /- 5.4 p<

10 post-aph / HDL-C post-aph post-aph aph/hdl /HDL-C post-aph ratios after and in the same 10 patients P1 P2 P3 P4 P5 P6 P7 P8 P9 P10 Mean post-aph /HDL-C ratios 1.3 +/- 0.5 p < /- 0.8

11 extraction rates following and method consisting in separating plasma and adsorbing plasma lipoproteins 5 patients Separating plasma and adsorbing plasma lipoproteins : 2 x PVs : 1.6 x BV + 1 L Pre-Aph mean Post- Aph mean Acute reductions +/- SD +/- SD (%) Plasma Plasma Plasma (n=126) (n=78) /- 51 +/- 54 +/- 10 +/- 10 +/ /- 5.9 p-value ns HDL-C 47 +/ / /- 8 Mean post-aph /HDL-C ratios 40 +/ / /- 0.5 Separating blood and adsorbing plasma lipoproteins : 1.5 +/- 0.5 Advantages for the patients : shortener duration of the procedures reduced by 48 +/- 16 min /- 8.2 ns <0.05 Advantages for the nurses : simplified installation 40 to 20 min

12 extraction rates following and method consisting in separating plasma and filtrating plasma lipoproteins 4 patients Separating plasma and filtrating plasma lipoproteins : 2 x PVs : 1.6 x BV + 1 L Pre-Aph mean +/- SD Post- Aph mean +/- SD Acute reductions (%) Filt Plasm Filt Plasm Filt Plasm (n=61) (n=96) /- 55 +/- 70 +/- 27 +/- 17 +/ /- 6.0 p-value ns HDL-C 56 +/ / / / / /- 9.3 <0.01 Mean post-aph /HDL-C ratios 1.3 +/- 0.7 Separating plasma and filtrating plasma lipoproteins : 1.6 +/- 0.5 <0.01

13 Tolerance assessment -No technical complications - 18 side effects / 419 sessions Mild arterial hypotension and pseudo-allergic features - 16 /18 : the session was stopped several minutes - 2 /18: the session was stopped - Biological tolerance - haemoglobin, WBC : decrease inferior than 5% - platelets : decrease by 10% - INR increased by 1.5 times - aptt increased by 4 times Partially resolved in 3 hours

14 Conclusions and perspectives Substantial numbers of patients and sessions Lpa: not enough results : Interesting results and good tolerance Statisticians help Important to consider simultaneously all parameters : Cardiologist Decrease in coronary disease Decrease in atherogenic lipoprotein Low decrease in antiatherogenic lipoprotein Clinical tolerance Hemostasis disturbances Procedure duration Quality of life Perform randomized studies to compare the LDL-aph techniques while considering the medical or the personal priorities for each patient Apheresis team Patient

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