Particle release in extracorporeal low-density lipoprotein lowering therapies

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.