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Evaluation of microparticle leakage during DALI LDL adsorption in a simulated clinical setting
1Nephrology Division, Medical Clinic I, Klinikum Grosshadern, University of Munich, Germany.
Abstract:
The aim of the present study was to investigate microparticle (Mp) leakage during simulated LDL-hemoperfusion using 12 DALI 750 adsorbers and the original DALI hardware under conditions strictly comparable to the clinical situation. Thus, the sessions were divided into 4 sections, i.e. priming and preparation of the adsorber followed by treatment (6-7 L at a flow rate of 60 ml/min) and reinfusion. As Mp counts can be performed only in clear, cell-free media, blood was replaced by normal saline in sections 2-4 of the simulated sessions. Mp counts were analysed for > or = 2, > or = 5, > or = 10 and > or = 25 microm particle sizes in the efferent line post adsorber using a standard light blockage method. As there are no official thresholds for particle release in extracorporeal circuits, the limits for infusion of large fluid volumes of 500, 100 (80), 25 and 5 (3) Mp/ml according to the Europäische Arzneimittelbuch, the British and American Pharmacopoeias were used. Mean particle counts for the sections 3 and 4 in which the patient is connected to the efferent line were 19, 7, 2 and 0 Mp/ml and amounted to < 10% of the above mentioned limits. Modifications of the standard simulation procedure by inserting additional pump stops or using different flow rates during the treatment phase slightly increased Mp leakage, but never exceeded the prescribed limits. In summary, no undue particle release could be detected during simulations of the clinical DALI LDL-adsorption procedure.
Insights
This study simulated LDL-hemoperfusion using DALI adsorbers, finding minimal microparticle (Mp) leakage. Results indicate the DALI system is safe for clinical use, with particle release well below safety limits.
Area of Science:
- Biomedical Engineering
- Extracorporeal Circulation
- Nanotechnology
Background:
- Lipid-lowering therapy often involves extracorporeal procedures like LDL-hemoperfusion.
- Assessing the safety of medical devices, such as adsorbers, requires evaluating potential particle release.
- Microparticle (Mp) leakage from extracorporeal circuits is a critical safety concern.
Purpose of the Study:
- To quantify microparticle (Mp) leakage during simulated LDL-hemoperfusion using DALI 750 adsorbers.
- To compare Mp leakage against established pharmacopoeial limits for infused fluids.
- To evaluate the safety of the DALI LDL-adsorption procedure concerning particle release.
Main Methods:
- Simulated LDL-hemoperfusion using DALI 750 adsorbers and hardware.
- Blood replacement with saline for microparticle analysis in sections 2-4.
- Light blockage method to quantify microparticles (≥2, ≥5, ≥10, ≥25 µm) in the efferent line.
- Comparison of measured Mp counts against European, British, and American Pharmacopoeia limits.
Main Results:
- Mean particle counts in sections 3 and 4 (patient connection) were 19, 7, 2, and 0 Mp/ml for the tested sizes.
- Measured microparticle levels were consistently below 10% of the pharmacopoeial infusion limits.
- Minor increases in Mp leakage occurred with procedural modifications but remained within safe limits.
Conclusions:
- The DALI LDL-adsorption procedure demonstrated no undue microparticle release during simulated clinical use.
- The DALI 750 adsorber system appears safe for clinical application regarding particle contamination.
- This study provides evidence supporting the safety profile of LDL-hemoperfusion with DALI technology.