DALI - the first human whole-blood low-density lipoprotein and lipoprotein(a) apheresis system in clinical use: procedure and clinical results

Background The DALI low-density lipoprotein (LDL) apheresis system is the f irst whole- blood apheresis system in regular clinical use. DALI stands for direct adsorption of lipoproteins, which describes the basic principle of operation of this newly developed LDL apheresis procedure. Methods The selective removal of LDLs and lipoprotein (a) [Lp(a)] is perfor med in human whole blood by adsorption onto polyacrylate-coated polyacrylam ide beads in an adsorber. This article describes the results of the first o pen multicentre clinical trial in 14 patients in whom the safety and the ef ficacy of the system were tested. All patients were treated on average 17 t imes on a weekly basis. In total, 238 sessions were carried out during the study without severe side-effects. On average, 7675 mL of the patients' who le blood was processed in about 2 h. Anticoagulation in the extracorporeal system was carried out by first giving a heparin bolus followed by continuo us addition of an acid citrate dextrose (ACD-A) infusion during the treatme nt. Results The processing of nearly 1 . 6 times the patient blood volumes resu lted in a reduction in the median LDL-cholesterol level by 66-77% (dependen t on the system configuration). The Lp(a) concentrations were reduced by 59 -73% (dependent on the system configuration). HDL-cholesterol, blood cell c ount and the other clinical parameters were not significantly affected. Conclusion Based on this short-term evaluation, the DALI apheresis system i s a well-tolerated, effective and simple way of reducing LDL and Lp(a) in h uman whole blood. The system has been introduced to clinical practice. Howe ver, to use the DALI apheresis system in clinical routine, further evaluati on of long-term effects is required.