First Steps Toward the Establishment of a German Low‐Density Lipoprotein‐Apheresis Registry: Recommendations for the Indication and for Quality Management

Abstract

New recommendations for the indication of treatment with selective extracorporeal plasma therapy low‐density lipoprotein apheresis (LDL‐apheresis) in the prevention of coronary heart disease are urgently needed. The following points are the first results of the ongoing discussion process for indications for LDL‐apheresis in Germany: all patients with homozygous familial hypercholesterolemia with functional or genetically determined lack or dysfunction of LDL receptors and plasma LDL cholesterol levels >13.0 mmol/L (>500 mg/dL); patients with coronary heart disease (CHD) documented by clinical symptoms and imaging procedures in which over a period of at least 3 months the plasma LDL cholesterol levels cannot be lowered below 3.3 mmol/L (130 mg/dL) by a generally accepted, maximal drug‐induced and documented therapy in combination with a cholesterol‐lowering diet; and patients with progression of their CHD documented by clinical symptoms and imaging procedures and repeated plasma Lp(a) levels >60 mg/dL, even if the plasma LDL cholesterol levels are lower than 3.3 mmol/L (130 mg/dL). Respective goals for LDL cholesterol concentrations for high‐risk patients have been recently defined by various international societies. To safely put into practice the recommendations for LDL‐apheresis previously mentioned, standardized treatment guidelines for LDL‐apheresis need to be established in Germany that should be supervised by an appropriate registry.

LDL lipid apheresis rapidly increases peripheral endothelial progenitor cell competence

“…The heparin-induced extracorporeal LDL apheresis (HELP) procedure was carried out with the Plasmat Futura 1 (Braun, Melsungen, Germany) and for direct adsorption of lipoproteins (DALI 1 ) the LDL-hemoperfusion system (Fresenius, St. Wendel, Germany) was used. LDL-A was performed on a weekly basis depending on mean LDL-cholesterol values and apheresis modalities (applied LDL-A method, treated volume, blood and plasma flow, anticoagulation) and were adjusted according to the national recommendations aiming at a LDL-C decrease of more than 60% or Lp(a) of more than 50% (Bundesvereinigung K. Mitteilungen: Zum Beschluss des Bundesausschusses der Ä rzte und Krankenkassen vom 24 [16]), respectively, and to patients' individual characteristics [17].…”

Dextran‐sulfate‐adsorption of atherosclerotic lipoproteins from whole blood or separated plasma for lipid‐apheresis—Comparison of performance characteristics with DALI and lipidfiltration

“…In total, 12 patients received 169 LDL apheresis treatments, which were analyzed. Indication for LDL apheresis was established according to German reimbursement guidelines (BUB guidelines), updated by a national working group [10,24]. All patients signed an informed consent form to participate in the investigation.…”

Management of Familial Hypercholesterolemias in adult patients: Recommendations from the National Lipid Association Expert Panel on Familial Hypercholesterolemia

“…[48][49][50][51] The procedure must be repeated every 1 to 2 weeks. In a single procedure, LDL apheresis typically removes at least 60% of the Apo B-containing lipoproteins.…”