LDL-HEMOPERFUSION - A NEW PROCEDURE FOR LDL-APHERESIS - FIRST CLINICAL-APPLICATION OF AN LDL-ADSORBER COMPATIBLE WITH HUMAN WHOLE-BLOOD

To date, lipid apheresis procedures can remove low-density lipoprotein (LDL) cholesterol (LDL-C) only from plasma. Thus, initially plasma ha s to be separated from the blood cells, which increases the costs and complexity of the extracorporeal circuit. This paper describes the fir st clinical application of a new LDL adsorber that eliminates LDL dire ctly from whole blood. The goal of this pilot study was to test the ef ficacy, safety, and feasibility of direct lipoprotein adsorption in pa tients. In a 2 center Phase II clinical trial, 12 hypercholesterolemic patients suffering from overt coronary or peripheral artery disease w ere treated once with LDL hemoperfusion. The new LDL adsorber (DALI, F resenius, St. Wendel, Germany) contained 480 mi of polyacrylate coated polyacrylamide gel. The anticoagulation consisted of an initial hepar in bolus followed by an acid citrate dextrose (ACD)-A infusion during the treatment. The processing of nearly 1 patient blood volume resulte d in a reduction of LDL-C by 45 +/- 8% and triglycerides by 23 +/- 20% . HDL-C, fibrinogen, and cell counts were not significantly influenced . In a subgroup of 5 patients who exhibited elevated lipoprotein (a) ( Lp[a]) levels, Lp(a) reduction was 43 +/- 15% (all results corrected f or plasma volume shifts). The sessions were clinically uneventful; the system was technically safe and easily handled. In conclusion, short- term LDL hemoperfusion by the DALI proved to be a safe, effective, and simple procedure for the treatment of patients suffering from symptom atic recalcitrant hypercholesterolemia. The present study represents a solid basis for the clinical long-term evaluation of this new techniq ue in the future.