Comparison of Two Apheresis Instruments (Old vs. New) for Granulocyte Collection: A Single Institutional Experience

Background:

A retrospective analysis was performed to evaluate the collection efficiency of two apheresis devices for granulocytes using the Spectra Optia (TerumoBCT) vs. the Cobe Spectra (Cobe: TerumoBCT) which served as control.

Study Design and Methods:

A total of 410 granulocyte collections (GCs) were collected from volunteer healthy blood donors (<4%) and family and friends of severely neutropenic oncology patients requiring GCs from July 2014 to November 2015.

All healthy male and females donors eligible to donate blood with peripheral venous access were allowed to donate granulocytes after first undergoing Platelet Apheresis with very few exceptions. This was performed to evaluate the donor's ability to undergo a lengthy apheresis procedure.

All first time donors were mobilized with G-CSF (600/480 mcg) and/or Dexamethasone 8 mg 12 hours prior to the apheresis. Both instruments were primed with acid citrate-dextrose (ACD-A) and then changed to a coagulation buffer of a 500 mL bag of 6% hydroxyethyl starch (HES) to which 40 mL of trisodium citrate 46.7% was added. The maximum allowed time for the apheresis procedures on both devices was 3 hours. 186 consecutive GCs were performed using the Spectra Optia from March to November 2015 vs. 224 consecutive GCs using the Cobe Spectra device from July 2014 to March 2015 and served as control. The GCs were transfused to both adult and pediatric patients. GC products greater than 500 mL were divided into double/triple or quadruple units based on the total white count of the unit.

Hematopoietic stem cell transplant and pediatric patients received irradiated GCs whereas leukemia patients received non-irradiated GCs.

Statustical Method:

All statistical analysis were performed using R version 3.3.0. The Wilcoxon rank-sum test was used to compare continuous variables between the Spectra Optia and Cobe Spectra. All statistical tests used a significance level of 5%. No adjustments for multiple donations were made. The table summarizes characteristics by group [ Cobe Spectra (COBE) vs. Spectra Optia (SPECTRA)]. The table presents for each variable, by group, the number of patients, the minimum ("Min") and maximum ("Max") values, the quartiles ("q1" and "q2"), the median, mean and the standard deviation ("SD"), along with the number of missing values ("#NA"), if any. For each parameter, there is also a p-value corresponding to a Wilcoxson rank-sum test.

Results:

From a total of 186 Spectra Optia granulocytapheresis we were able to process and obtain 433 GC units (21 single, 90 double, 72 triple and 4 quadruple units) as compared to the Cobe Spectra where 224 granulocytapheresis yielded 393 GC units (single 85, double 109 and 30 triple units). All of the split/unspilt GCs from both apheresis devices had a minimum wbc count > 1.0 x 10e10.

We found the following parameters - total blood volume processed, totall WBC collected, run time, bag wbc, absolute neutrophil count, absolute lymphocyte count, granulocyte collection efficiency, post-stimulation platelet count, absolute platelet count, MPV and number of GCs split were significantly higher ( p = <0.0001) using the fully automated Spectra Optia while volume collected, hematocrit, bag platelets and platelet collection efficiency were significantly higher ( p=<0.0001) using the Cobe Spectra. The age of the Cobe Spectra patients were older on average (p=0.00015) (Table)

The weight, height, pre- and post stimulation WBC and pre-stimulation platelet counts of the donors were of no significance. (Table)

Conclusion:

The ability to achieve higher granulocyte counts per liter of blood processed with a higher granulocyte CE using the fully automated Spectra Optia has allowed us to process and split Granulocyte Units leading to the availability of multiple units thus easing some of the Granulocyte shortages that our severely neutropenic oncology patients currently experience.

Reference

1. Cancelas JA, Padmanabhan A, Le T et al. Spectra Optia granulocyte apheresis collections results in higher collection efficiency of viable, functional neutrophils in a randomized crossover, multicenter trial. Transfusion; 2015; 55: 751-55

2. Leitner GC, Kolovratova K, Horvath M et al. Granulocyte collection using a novel apheresis system eases the procedure and provides concentrates of high quality. Transfusion 2015; 55: 991-5

Table

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Characteristics by Group

Table

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Characteristics by Group

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