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Comparative evaluation of a heparin-citrate anticoagulation for LDL-apheresis in two primary apheresis systems
Doris Handschel1, Michiel Etienne Janssens2, Marion Gericke2
1German Haemapheresis Centre, Cologne, Germany.
Insights
A new protocol for low-density lipoprotein (LDL)-apheresis on the Spectra Optia platform is feasible and safe for familial hypercholesterolemia patients. This method ensures efficient LDL removal with minimal adverse events, offering a viable alternative to older systems.
Area of Science:
- Cardiovascular Medicine
- Medical Technology
- Biochemistry
Background:
- The COBE Spectra system for apheresis is being replaced globally.
- Familial hypercholesterolemia (FH) requires effective lipid-lowering therapies like apheresis.
- There is a need for updated apheresis protocols on newer platforms like Spectra Optia.
Purpose of the Study:
- To describe and evaluate a new protocol for low-density lipoprotein (LDL)-apheresis using the Spectra Optia system.
- To compare the efficacy and safety of Spectra Optia with the older COBE Spectra system.
- To assess coagulation and platelet activation markers during apheresis.
Main Methods:
- A comparative study involving 16 procedures on COBE Spectra and 18 on Spectra Optia.
- Utilized low-dose heparin-citrate anticoagulation (AC) with varying inlet:AC ratios.
- Assessed coagulation markers, platelet activation, blood cell counts, and plasma removal efficiency.
Main Results:
- Both systems showed similar coagulation and platelet activation markers.
- Spectra Optia demonstrated higher plasma removal efficiency (84% vs. 75%).
- Transient reversible clumping occurred in some Spectra Optia procedures but was managed by adjusting the inlet:AC ratio.
Conclusions:
- Apheresis procedures for familial hypercholesterolemia on the Spectra Optia system are feasible and safe.
- The new protocol using low-dose heparin-citrate anticoagulation is effective.
- Spectra Optia offers improved plasma removal efficiency compared to COBE Spectra.
Background:
As COBE Spectra has been replaced in many parts of the world, we describe a new protocol for low-density lipoprotein (LDL)-apheresis performed on familial hypercholesterolemia patients for the Spectra Optia platform.
Methods:
For all procedures, after administering a bolus of heparin of 2,500 U, 10,000 U of heparin added to a 600 ml ACD-A bag was used as anticoagulant (AC). In a first phase (A), 16 apheresis procedures with COBE Spectra using an inlet:AC ratio of 25:1 were compared to 18 LDL-apheresis treatments with Spectra Optia at split Inlet:AC ratios of 16:1/18:1 or 20:1/25:1. Platelet activation and coagulation markers were assessed. In a follow-up phase (B), 20 procedures on Spectra Optia using an inlet:AC ratio of 20:1 were performed.
Results:
Although coagulation markers and platelet activation analyzed were similar in both apheresis devices used, COBE Spectra procedures did not show any visual clumping in the sets. Visual analysis of clumping was highest in the Spectra Optia's 20:1/25:1 AC regimen (5/8 procedures). For the lowest Spectra Optia, AC regimen and during the follow-up phase reversible clump formation in the disposable set was similar (1/10 procedures). Clumping was successfully reversed in all cases by temporarily lowering the inlet:AC ratio to 18:1. Blood cell counts (WBC, Plt, Hct) were similar for both COBE Spectra and Spectra Optia procedures. Spectra Optia had a significantly higher plasma removal efficiency versus COBE Spectra (84% vs.75%, P < .05). No serious adverse events were observed.
Conclusion:
Apheresis procedures on the Spectra Optia system with low-dose heparin-citrate anticoagulation are feasible and safe.
