Efficacy and safety of DALI LDL‐apheresis at high blood flow rates: A prospective multicenter study

Direct adsorption of lipids (DALI) is the first LDL‐apheresis method compatible with whole blood. Usually, the blood flow rate is adjusted at 60–80 ml/min, which results in session times of about 2 hr. The present study was performed to test the safety and efficacy of low‐density lipoprotein cholesterol (LDL‐C) and lipoprotein (a) [Lp(a)] removal by DALI at high blood flow rates in order to reduce treatment time. Thirteen chronic DALI patients in seven centers suffering from hypercholesterolemia (LDL‐C 162 ± 42 mg/dl at baseline) and coronary artery disease were treated on a weekly or biweekly basis by DALI apheresis. The blood flow rate Q B was held constant for at least two sessions, respectively, and was increased from 60 to 80, 120, 160, 200, and 240 ml/min. All patients had pre‐existing av‐fistulas. The anticoagulation was performed by a heparin bolus plus ACD‐A at a ratio of citrate: blood ranging from 1:20 to 1:90. Clinically, the sessions were well tolerated and only 26/201 sessions (12%) of the treatments were fraught with minor adverse events. Acute LDL‐C reductions (derived from LDL‐C levels determined by lipoprotein electrophoresis) averaged 72/66/60/53/50/48% for Q B = 60/80/120/160/200/240 ml/min. Lp(a) reductions were 68/67/62/60/58/56%, whereas HDL‐C losses were ≤10%. Routine blood chemistries and blood cell counts remained in the normal range. Treatment times averaged 142/83/45 min at Q b = 60/120/240 ml/min. On average, DALI LDL‐apheresis could be performed safely and effectively at high blood flow rates up to at least 120 ml/min in patients with good blood access, which significantly reduced treatment time from 142 to 83 min (−42%). J. Clin. Apheresis 18:157–166, 2003. © 2003 Wiley‐Liss, Inc.