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Particle release in extracorporeal low-density lipoprotein lowering therapies
K Martins1, P Ahrenholz, G B Matic
1BioArtProducts GmbH; Dialyse-Gemeinschaft Nord e.V. Rostock, Germany.
Abstract:
Release of microparticles into the blood during extracorporeal circulation must be kept low because of possibly serious acute and chronic adverse effects. Concentration and size distribution of microparticles were measured during simulated treatments (n = 7) on original equipment for 2 standard low-density lipoprotein (LDL) elimination procedures (DALI 750, Fresenius AG, St. Wendel, Germany and Liposorber, Kaneka Corporation, Osaka, Japan) and compared to hemofiltration solutions. For both systems as well as in hemofiltration solutions, the mean particle concentrations in 500 ml portions gathered from the efferent blood line stayed below 10% of pharmacopoeia standards for infusion solutions (United States Pharmacopoeia, European Pharmacopoeia) in all measured size classes. Although particle concentrations were comparable in all systems, the mean total number of particles > or =2 microm released per session was lowest in the DALI (167,000) compared to the Liposorber (465,000) and hemofiltration solutions (2,240,000). This was mainly due to different total processed blood volumes necessary to achieve the required LDL reduction.
Insights
Microparticle release during extracorporeal circulation was evaluated for low-density lipoprotein (LDL) apheresis systems. Both DALI and Liposorber devices, along with hemofiltration, showed low particle concentrations, meeting pharmacopoeia standards.
Area of Science:
- Biomedical Engineering
- Cardiovascular Science
- Medical Device Technology
Background:
- Microparticle release during extracorporeal circulation poses risks.
- Maintaining low microparticle levels is crucial for patient safety.
- Standard low-density lipoprotein (LDL) elimination procedures require careful monitoring.
Purpose of the Study:
- To quantify and compare microparticle release during two LDL apheresis systems and hemofiltration.
- To assess compliance with pharmacopoeia standards for particle concentration.
- To identify which extracorporeal circulation method minimizes microparticle release.
Main Methods:
- Simulated treatments using DALI 750 and Liposorber LDL apheresis devices.
- Comparison with hemofiltration solutions.
- Measurement of microparticle concentration and size distribution in 500 ml blood samples.
- Analysis of particle release per session based on processed blood volume.
Main Results:
- All tested systems (DALI, Liposorber, hemofiltration) released microparticles below 10% of pharmacopoeia standards.
- Particle concentrations were comparable across all systems.
- The DALI system released the lowest mean total number of particles (≥2 microm) per session (167,000) compared to Liposorber (465,000) and hemofiltration (2,240,000).
Conclusions:
- Standard LDL apheresis and hemofiltration systems demonstrate safe microparticle release levels.
- The DALI system showed the lowest particle release per session.
- Differences in total processed blood volume significantly influenced total particle release per session.