Deutsches Lipoproteinapherese-Register

Weltweit einmalig – Das deutsche Lipoproteinapherese Register: eine Zwischenbilanz.

Seit 2012 besteht das bundesweite Deutsche Lipoproteinapherese-Register (DLAR), die Laufzeit ist vorerst bis 2019 vorgesehen. Ein Interview mit dem Nephrologen und Mitbegründer des Registers, Privatdozent Dr. Schettler aus Göttingen, über den langen Atem und die vielen Mitstreiter, die es zur Schaffung eines solchen Registers braucht, aber auch über die Erfolge und die Zukunft des Registers.

Current insights into the German Lipoprotein Apheresis Registry (GLAR) - Almost 5 years on

For the first time data generated by the GLAR shows that LA lowers the incidence rate of cardiovascular events in patients with high LDL-C and/or high Lp(a) levels, progressive CVD and maximally tolerated lipid lowering medication. In addition LA treatments were found to be safe, exhibiting a low rate of side effects.

The German Lipoprotein Apheresis Registry (GLAR) – almost5 years on

The data generated by the GLAR shows thatLA lowers the incidence rate of cardiovascular events inpatients with high LDL-C and/or high Lp (a) levels, pro-gressive CVD, and maximally tolerated lipid lowering med-ication. In addition, LA treatments were found to be safewith a low rate of side effects.

First data from the German Lipoprotein Apheresis Registry (GLAR)

In recent years the Federal Joint Committee (G-BA), a paramount decision-making body of the German health care system challengedthe approval of diagnostic and therapeutic procedures for regular reimbursement, including lipoprotein apheresis therapy. Years before an inter-disciplinary Germanapheresis working group, establishedby members of both German Societiesof Nephrology (Verband Deutsche Nierenzentren(VDN), Deutsche Gesellschaft für Nephrologie (DGfN)), initiated a revision of the indication of lipoprotein apheresis therapy according to currentguidelines and recommendations for the treatment of lipid disorders. This working group was convinced, that data derived from a registry wouldsupport lipoprotein apheresis as a therapy for severe hyperlipidemic patients suffering from progressive cardiovascular diseases.
Methods and results: In 2009 the working group established the indication for lipoprotein apheresis with respect to current cardiovascularguidelines and scientific knowledge for the registry, which are in line with the reimbursement guidelines. In 2011 financing by sponsors wassecured and an internet-based registry was created. A pilot project with 5 apheresis centers finished in 2012 - since then the registry is available to all German apheresis centers.
Conclusions: There has been consensus between the medical societies and health care carriers regarding the need for a German LipoproteinApheresis Registry (GLAR). The launch of this registry complies with requirements of the Federal Joint Committee (G-BA). Com-plementing the Pro(a)LiFe-Study, first data from GLAR support the safety of the different apheresis treatment procedures. In addition thesefirst data suggest, with respect to the results of Pro(a)LiFe-Study, effectiveness in preventing cardiovascular progression as well. Here,further data are needed to statistically substantiate these early findings.

Impact of the German Lipoprotein Apheresis Registry (DLAR) on therapeutic options to reduce increased Lp(a) levels

The available numbers suggest in parts very good response by the participating centres to the DLAR. Unfortunately, there are also centres that have not documented any patients so far or LA treatments at all. The benchmark values for reduction rates in lipoprotein concentration required by the directives of the German Federal Joint Committee (G-BA) have all been met. The decrease in MACE and MANCE rates currently observed is very promising. However, the comparably short runtime of the registry does not allow for high confidence in the current results. Certainly, reliable data will be extractable in the coming years. Given the high interest expressed by European neighbours, the extension of the registry to the European level should be a future goal for the DLAR as well.

The "Deutsche Lipoproteinaphereseregister (DLAR)" - What is the background?

The Federal Joint Committee (G-BA), a paramount decision-making body of the German Healthcare System, issued to build up a registry for patients suffering from severe increases of LDL cholesterol or lipoprotein(a) (Lp(a)) levels with severe progress of cardiovascular diseases undergoing regular lipoprotein apheresis (LA) treatment. Since April 2012, the „Deutsche Lipoproteinaphereseregister (DLAR)” works in routine operation, in which all patients undergoing regular LA treatment should be documented. The German institution „Wissenschaftliches Institut für Nephrologie (WiNe)” is responsible for the registry arrangement and data assessment. Therefore, WiNe has established an interdisciplinary advisory board. This board has to monitor the quality of data and LA treatments and has to issue a registry report in yearly intervals. The aim of DLAR is not only to record lipid data before and after apheresis sessions as quality criteria but also e. g. to prospectively register treatment side effects, cardiovascular events in these patients before LA treatment was initiated and during chronic LA treatment.