Related Experiment Videos
Evaluation of microparticles released from an adsorber used for low density lipoprotein apheresis
1Kaneka Pharma Europe N.V., Brussels, Belgium.
Abstract:
Microparticle (MP) released from a DALI 750 Adsorber column for low density lipoprotein apheresis, which is used in a direct hemoperfusion system, was evaluated. The numbers of MP were measured by a light blockage method in the effluents from the column during the rinsing (priming) procedure using a priming solution, and the simulated treatment procedure using a physiologic saline solution as a substitute for whole blood. An unacceptable number of MP were released from the column during the simulated treatment after rinsing with an amount of solution prescribed by the manufacturer. MP concentrations (mean values of three experiments) in the initial 300 ml of the effluent were 639.9, 75.1, and 3.6 pieces/ml for > or = 5 microm, > or = 10 microm, and > or = 25 microm, respectively, and neither the result for > or = 5 microm nor for > or = 10 microm meets the requirement for solutions for injection defined in the United States Pharmacopoeia XXIII or the British Pharmacopoeia of 1993. Furthermore, a large number of MP still remained in the column after all the simulated operations. These findings suggest that the column has a potential to release an unacceptable number of MP into the patient during treatment. Further investigation on the influence of the MP released into the patient's circulation is necessary.
Insights
Microparticle release from LDL apheresis columns can exceed safety limits. Further research is needed to understand the impact of these microparticles on patient health during hemoperfusion.
Area of Science:
- Biomedical Engineering
- Materials Science
- Cardiovascular Research
Background:
- Low-density lipoprotein (LDL) apheresis is a crucial treatment for hyperlipidemia.
- Direct hemoperfusion systems utilize adsorber columns to remove LDL.
- Microparticle (MP) release from medical devices can pose risks to patients.
Purpose of the Study:
- To evaluate microparticle (MP) release from a DALI 750 Adsorber column during LDL apheresis.
- To assess MP concentrations against pharmacopeial standards for injectable solutions.
- To determine the potential risk of MP embolization during hemoperfusion.
Main Methods:
- MP release was measured using a light blockage method.
- Effluents were analyzed during rinsing and simulated treatment procedures.
- MP concentrations were quantified for particles >= 5, >= 10, and >= 25 microm.
Main Results:
- Unacceptable MP numbers were released during simulated treatment, exceeding USP and BP standards for particles >= 5 and >= 10 microm.
- MP concentrations in initial effluents reached 639.9 pieces/ml (>= 5 microm) and 75.1 pieces/ml (>= 10 microm).
- Significant MP numbers remained within the column post-procedure.
Conclusions:
- The DALI 750 Adsorber column may release unacceptable MP levels into patients during LDL apheresis.
- Further investigation is required to understand the clinical implications of MP release during hemoperfusion.
- Adherence to rinsing protocols may not be sufficient to prevent MP release.