Chairs: P. S. Malchesky (ICAOT, Painsville, OH, USA), B. Stegmayr (Lund, Sweden)
|Affinity sorbents for therapeutic apheresis one Team development.
1 National Medical Research Center of Cardiology, Ministry of Health of Russian Federation, Institute of Experimental Cardiology, Moscow, Russian Federation
Abstract text :
After first the publications by Wilhelm Stoffel, Helmut Borberg, and Kurt Oette et al. from Cologne University in 1981, we started designing different affinity sorbents for medical application at the Cardiology Research Center in Moscow, on that time USSR.
Our first sorbent contains sheep polyclonal antibodies (PcAb) against human low density lipoprotein (LDL) immobilized to agarose beads, and it was typical "like me" material compare to the Cologne group development. In December 1983 the first LDL apheresis treatment with our own columns was performed in Moscow. We have used our first experience as the basis for developing an unified platform to design a new generation of sorbents for therapeutic apheresis (TA). General information about further development is shown in the table.
Conclusion: Affinity sorbents differing by ligands, coupling chemistry and matrixes can be used for successful apheresis treatment of patients with severe diseases resistant to any other therapies. The current goal for new developments is the search of new pathogenic targets that can be removed by adsorption technology with TA. Extracorporeal removal of pathogens by specific adsorption can be used as «proof hypothesis» approach for new drags development.
|The German Lipoprotein Apheresis Registry (GLAR) – more than 5 years on
1 Klinikum der Universität München, Stoffwechselambulanz, München, Germany
2 BRAVE e Benefit for Research on Arterial Hypertension, Dyslipidemia and Vascular Risk and Education e. V., , Göttingen, Germany
3 BioArtProducts GmbH , , Rostock, Germany
4 University Hospital, Technische Universität Dresden, Department of Internal Medicine III, Dresden, Germany
5 Center for Nephrology, Hypertension, and Metabolic Diseases, , Hannover, Germany
6 Medical Care Centre Kempten-Allgäu, , Kempten, Germany
7 AGAPLESION Markus Hospital, Department of Medicine II for Nephrology, Hypertension and Vascular Risks, Frankfurt, Germany
8 Scientific Institute for Nephrology (WiNe), , Düsseldorf, Germany
9 Nephrologisches Zentrum Göttingen GbR, , Göttingen, Germany
Abstract text :
Since 2005 an interdisciplinary German apheresis working group has been established by members of both German Societies of Nephrology and Lipidologists. The working group completed the data set for the registry according to the current European guidelines on cardiovascular disease prevention and the German regulation for lipoprotein apheresis (LA) in 2009. In 2011 the German Lipoprotein Apheresis Registry (GLAR) was launched and data are available over 5 years now.
During the time period 2012-2017, the number of participating apheresis centers continuously grew to 77. They collected retrospective and prospective observational data of 1470 patients undergoing LA treatment. The data focus on cardiovascular risk factors, treatments, and lipid values and cardiovascular events over time, and are collected and analyzed in the GLAR via an online platform.
A total of 25,884 completely documented LA treatments were entered into the database. All patients treated by LA showed a median low density lipoprotein-cholesterol (LDL-C) reduction rate of 68.5 %, and a median lipoprotein(a) (Lp(a)) reduction rate of 71.3%. As in the Pro(a)LiFe study, patient data were analyzed to the incidence rate of coronary events (MACE) 1 and 2 years before the beginning of LA treatment (y - 2 and y - 1) and prospectively two years on LA treatment (y 1 and y 2). During two years of LA treatment a MACE reduction of 76.4 % was observed. In the years considered, adverse effects of LA treatment were low (5.9 %) and mainly comprised puncture problems.
The data generated by the GLAR show 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, safety and a low rate of adverse effects are confirmed.
||New results from the WAA-Registry
1 Umea University, Sweden, Public Health and Clinical Medicine, Umea, Sweden
Abstract text :
|Towards a consensus – integrating lipoprotein apheresis with new lipid-lowering drugs
1 Sapienza University of Rome, Molecular Medicine, ROMA, Italy
Abstract text :
Although many important advances are being made in the field of lipid-lowering therapy, still many dyslipidaemic patients do not attain sufficient lipid-lowering, as a result of which they remain at high cardiovascular (CV) risk. Several classes of novel lipid-lowering agents are currently being evaluated to further reduce CV risk. These may be exploited if conventional therapies do not yield adequate results. Lipoprotein apheresis (LA) is highly effective at lowering atherogenic lipoprotein levels. The procedure is associated with cyclical rebound between procedures. When combined with LA, novel lipid-lowering therapies may smoothen out the rebound effect. This may have the added benefit that the frequency of LA sessions may be decreased. This document discusses the method and effects of LA, and summarises data of the emerging lipid-lowering drug classes, including the available evidence on combination therapy with LA. Subsequently, indications for LA are briefly described, after which treatment options are discussed. Recommendations are given based on the latest evidence. More studies, including on outcome data, on combining LA with inhibitors of PCSK9, ApoB synthesis or CETP, and HDL mimetics, and other novel lipid-lowering strategies in development, are highly warranted. Documenting clinical experience, data on patient characteristics and chosen treatment strategies and effects in an international registry can accelerate expanding the evidence base on treatment in these individuals at high CV risk. The Multidisciplinary International Group for Hemapheresis TherapY and MEtabolic DIsturbances Contrast (Mighty Medic) Working Group aims to set up the proposed international registry on LA. Moreover, Mighty Medic will network with sister societies, and facilitate multicentre scientific collaborations on genetic, mechanistic and pooled case-studies.
Claudia Stefanutti and the MIGHTY MEDIC Group