Prospective crossover study for a standardized comparison of the dextrane sulfate whole blood and plasma apheresis system in patients with cardiovascular disease and severe dyslipidemia.

Background And Aims: The objective of this study was a standardized comparison of the safety and effectiveness of the Kaneka (Kaneka Corporation, Osaka, Japan) whole blood (Liposorber DL-100) and plasma (Liposorber LA-15) lipoprotein apheresis (LA) system to optimize the individual therapy of patients with cardiovascular disease and severe dyslipidemia.

Methods: Six chronic LA patients with a pre-treatment LDL-C < 6 mmol/l in steady state received a total of three treatments with the LA-15 device, followed by three treatments with the DL-100 device or vice versa. To achieve a standardized comparison the treated blood volume for any patient was kept identical for both procedures. Sampling points for total cholesterol, LDL-C, HDL-C, Lp(a), triglyceride, blood count, and bradykinin measurements were adjusted for both techniques.

Results: Total cholesterol, LDL-C, HDL-C, Lp(a), and triglycerides were reduced by 59.2 ± 6.5%, 79.3 ± 6.9%, 7.1 ± 3.9%, 87.3 ± 3.1%, 22.5 ± 24.2% using the DL-100 system and by 51.4 ± 5.2%, 65.2 ± 3.7%, 2.2 ± 4.9%, 72.7 ± 2.2%, 46.5 ± 9.4% using the LA-15 system, showing that the DL-100 adsorber was significantly more effective for lowering total cholesterol (p = 0.044), LDL-C (p = 0.001), Lp(a) (p = 0.029), while triglycerides were reduced to a higher extent by the plasma system (p = 0.046) in this patient group. The regenerable LA-15 adsorber columns showed a higher removal capacity considering the difference between inflow and outflow concentrations. Bradykinin levels significantly increased up to 145 fold in the outflow lines using the plasma system (p = 0.028), but not systemically. There was no significant bradykinin generation using the whole blood adsorber.

Conclusion: In conclusion, the whole blood system was faster and more effective in this LA patient group with pre apheresis LDL-C<6 mmol/l. Whether the regenerable plasma system is more effective in patients with higher LDL-C content should be evaluated in future standardized comparisons.