Direct adsorption of lipoproteins (DALI) from whole blood: First long-termclinical experience with a new LDL-apheresis system for the treatment of familial hypercholesterolaemia

Background: The DALI (direct adsorption of lipoproteins) LDL-apheresis syst em is a novel device for the removal of lipoproteins from whole blood. Methods: We report the first long-term treatment experience (16.7 +/- 12.6 months; 57 +/- 43 treatments / patient) using different DALI adsorber sizes (DALI-500, DALI-750, DALI-1000) in seven patients with homozygous (n =1) a nd severe heterozygous familial hypercholesterolaemia. For each treatment, 1.6 fold of the calculated blood volume was processed. Treatments were sche duled at weekly or two-weekly intervals. Results: The smallest DALI-500 configuration was unable to achieve sufficie nt removal of LDL cholesterol, with the adsorber being exhausted already at desorption of 65% of the calculated blood volume. In contrast, both larger adsorber systems effectively removed lipoproteins until the end of treatme nt. Therefore, the DALI-750 device was used for long-term treatment. LDL cholesterol (mean pretreatment value: 179 +/- 44 mg/dl) was reduced by 73.4 +/- 7.7% and Lp(a) levels (mean pretreatment value: 43 +/- 33 mg/dl) b y 69.5 +/- 8.3%. HDL cholesterol (mean pretreatment value: 47 +/- 15 mg/dl) was reduced by 16.3 +/- 8.0% during the treatment. In the long term, LDL c holesterol was reduced by 54.0 +/- 10.5% - from 259 +/- 101 mg/dl to 119 +/ - 19 mg/dl. No serious side effects occurred during the treatment. Long-term evaluation of other laboratory parameters showed a reduction in haemoglobin due to tr eatment-associated blood loss despite frequent iron supplementation. Conclusion: Sufficient reductions in LDL cholesterol and Lp(a) were achieve d using the DALI-750 system and the treatment was well tolerated. The easy use and short period of 153 +/- 22 minutes required for each treatment are the major advantages of the DALI system as compared to other available LDL- apheresis devices. Potential particle release from the adsorber into the ci rculation must be ruled out before the system can be introduced in clinical routine.