Current view: indications for extracorporeal lipid apheresis treatment

Abstract

BackgroundOne of the first investigations concerning extracorporeal treatment of hypercholesterolemia was performed in 1967 by plasma exchange in patients with homozygous or severe heterozygous familial hypercholesterolemia (FH). In the following decades, several specific lipid apheresis systems were developed to efficiently eliminate low-density lipoprotein (LDL) cholesterol and Lp(a) cholesterol in hypercholesterolemic patients. In the early 1980s, the main clinical indication has been homozygous FH including mainly children and pregnant women. In consideration of the current development of lipid-lowering regimens and scientific knowledge of preventing progression of cardiovascular diseases, the spectrum of indications to initiate lipid apheresis was extended due to still insufficient lipid-lowering therapy in some clinical cases. However, a generally accepted indication for lipid apheresis treatment is still under discussion. In Germany, the target-oriented distribution of increasingly limited healthcare resources demand data which support the benefit of established treatment procedures such as lipid apheresis. In recent years, the Federal Joint Committee (G-BA), a paramount decision-making body of the German Healthcare System, issued to reassess the approval of chronic lipid apheresis therapy for regular reimbursement. Therefore, in 2005, an interdisciplinary German Apheresis Working Group has been established by members of both the German societies of nephrology. One of the first goals of this working group was a revision of the indications for lipid apheresis corresponding to current guidelines and recommendations for the treatment of lipid disorders. In addition, recently new pathophysiological perceptions of the impact of lipoproteins on atherogenesis and thrombosis were also considered.Methods and ResultsSince 2005, the working group met on a regular basis to substantiate the first defined goals. The indications for lipid apheresis were critically revised with respect to actual results from clinical investigations, cardiovascular guidelines, and scientific knowledge and were accepted by the members of the apheresis working group.ConclusionsThere is consensus between the medical societies and health insurance funds regarding the need for general accepted guidelines for lipid apheresis. Recommendations for the indications of lipid apheresis were developed, but additionally these results should be confirmed by medical societies to transform them to guidelines. However, due to limited data showing that lipid apheresis has effects on the progression of cardiovascular diseases all members of the apheresis working group support a project for creating a lipid apheresis registry. This apheresis registry has been developed and recently started. The primary goal is to substantiate prospective long-term data on clinical outcome of chronic lipid apheresis treatment and to support additional clinical research activities in this field. In addition, this registry should comply with the actual requests of the Federal Joi...

Integrated guidance on the care of familial hypercholesterolaemia from the International FH Foundation

“…In developing countries, creative approaches, such as corporate support and public donations, should be adopted to support the funding of LA. There is a need for an extended international network of treatment centres and registry of patients on LA [150,152,157].…”

Integrated guidance on the care of familial hypercholesterolaemia from the International FH Foundation

“…By contrast to homozygous FH, the social/patient acceptability and cost-effectiveness of LA for treating refractory heterozygous FH remains unclear and needs further evaluation [156]. Elevation in plasma Lp(a) levels is a reimbursable indication for LA in Germany, but the evidence supporting the value of apheresis beyond reduction in LDL-cholesterol is questionable [152,154,157]. In homozygous children, LA should be considered by age 5 years and no later than 8 years [8,22,152,158].…”

Lipoprotein Apheresis in Patients With Maximally Tolerated Lipid-Lowering Therapy, Lipoprotein(a)-Hyperlipoproteinemia, and Progressive Cardiovascular Disease

“…The following parts of this guideline are essential for baseline characteristics of patients enrolled in this prospective study 8,9 : §1 Aim and Contents: (1) Lp(a)-HLP should be isolated in the sense that all other cardiovascular risk factors have to be under individually optimized treatment. 8,9 The threshold of 2.14 µmol·L −1 (60 mg·dL −1 ) for Lp(a) was supported by the European Consensus Panel recommending a desirable level below the 80th percentile, ie, <1.79 µmol·L −1 (50 mg·dL −1 ). 4 The reimbursement guideline has no exclusion criteria regarding comorbid conditions and no criterion of an explicit number or frequency of events.…”

“…Primary prevention for homozygous familial hypercholesterolemia and secondary prevention for heterozygous familial hypercholesterolemia or severe forms of hypercholesterolemia associated with progressive clinical courses are indications for chronic treatment after approval by committees of regional associations of statutory health insurance physicians. 8 The ability of LA methods to lower Lp(a) as effective as LDLcholesterol (LDL-C) led to encouraging pilot experiences in a small number of patients with Lp(a)-hyperlipoproteinemia (Lp(a)-HLP) and strikingly progressive CAD. Consequently, in 2008, the German Federal Joint Committee decided to add Lp(a)-HLP as an indication for chronic LA with regular reimbursement.…”