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DALI—the first human whole‐blood low‐density lipoprotein and lipoprotein (a) apheresis system in clinical use: procedure and clinical results
Author(s) -
Dräger,
• Julius,
Kraenzle,
Schaper,
Toepfer,
Zygan,
Thomas D. Otto,
Steinhagen-Thiessen
Publication year - 1998
Publication title -
european journal of clinical investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.164
H-Index - 107
eISSN - 1365-2362
pISSN - 0014-2972
DOI - 10.1046/j.1365-2362.1998.00395.x
Subject(s) - apheresis , ldl apheresis , medicine , extracorporeal , whole blood , lipoprotein , low density lipoprotein , heparin , clinical trial , cholesterol , surgery , platelet
Background The DALI low‐density lipoprotein (LDL) apheresis system is the first 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 performed in human whole blood by adsorption onto polyacrylate‐coated polyacrylamide beads in an adsorber. This article describes the results of the first open multicentre clinical trial in 14 patients in whom the safety and the efficacy of the system were tested. All patients were treated on average 17 times 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‘ whole blood was processed in about 2 h. Anticoagulation in the extracorporeal system was carried out by first giving a heparin bolus followed by continuous addition of an acid citrate dextrose (ACD‐A) infusion during the treatment. Results The processing of nearly 1.6 times the patient blood volumes resulted in a reduction in the median LDL‐cholesterol level by 66–77% (dependent on the system configuration). The Lp(a) concentrations were reduced by 59–73% (dependent on the system configuration). HDL‐cholesterol, blood cell count and the other clinical parameters were not significantly affected. Conclusion Based on this short‐term evaluation, the DALI apheresis system is a well‐tolerated, effective and simple way of reducing LDL and Lp(a) in human whole blood. The system has been introduced to clinical practice. However, to use the DALI apheresis system in clinical routine, further evaluation of long‐term effects is required.