Improvement of plateletpheresis via technical modification on the MCS+

SUMMARY: Background: With the advantage of easy operation and high reliability, Haemonetics multicomponent collection system (MCS+) is widely used as a blood cell separator in clinical application. Objectives: The aim of this study was to evaluate the effect of technical parameter modification as utilised on the MCS+ to improve the quality of platelet yielded as well as donor comfort. Methods: After informed consent, a total of 118 donors, well matched for baseline parameters, were included in the study from December 2012 to April 2013. Sixty ‐ one donors underwent single ‐ dose plateletpheresis (SDP), and the other 57 donors underwent double ‐ dose plateletpheresis (DDP) before and after technical modification on the MCS+, respectively, according to the manufacturer's instructions. The procedures were evaluated, focusing on whole blood processed (WBP), processing time (PT) and number of cycles were measured, as well as the quality of products. Results: No severe adverse reaction was found during donation. WBP, PT and number of cycles after modification were all reduced significantly in both SDP and DDP groups (P   <   0·01). In addition, 80·51 % (95 in 118) of the total post ‐ modification products were qualified, presenting with high quality. Besides, the comfort of donors was also improved probably because of the reduced PT. Conclusion: Adjustment of the relevant technical parameters on MCS+ could produce a beneficial effect on the procedure measures and ensure a high ‐ quality platelet production.

MCS+; modification; platelet quality; plateletpheresis; processing time

Medical development, including solid ‐ organ or bone ‐ marrow transplantation, is accompanied by an increased transfusion demand for platelets (PLTs) and red blood cells (RBCs). Ageing of the population, as well as more stringent exclusion criteria for blood donation, makes the recruitment and retention of eligible donors increasingly more difficult. Multicomponent apheresis, preparing multiple blood products in a single donation procedure, may have the potential to counteract this problem and to reduce both costs and risks inherent with allogenic transfusion (Moog, [16] ; Popovsky, [19] ; Valbonesi et al., [28] ). As a result, blood centres encourage the industry to introduce new apheresis systems or to modify existing equipment for better productivity and donor safety.

Plateletpheresis, one part of various kinds of hemapheresis, is a process of separating PLTs from whole blood performed by an automated device (Simon, [24] ; Agarwal & Verma, [1] ). The platelet apheresis is generally acknowledged to be safe and preferred by healthy donors with the advantages of fewer donor exposure time and transmission ‐ related diseases (Strauss, [25] ; Rock & Sutton, [21] ). With the technological development of plateletpheresis system, different plateletpheresis machines have been invented to obtain a high ‐ quality product with faster speed and few adverse effects (Burgstaler et al., [6] ; Menichella et al., [13] ). Haemonetics multicomponent collection system (MCS+) is a widely used blood cell separator in clinical application, which could provide for the simple and very rapid collection of RBCs, white blood cells, PLTs, plasma or haematopoietic stem cells (Bornhäuser et al., [3] ; Gratama et al., [9] ; Moog, [17] ). The MCS+ is being used with the advantage of easy operation and high reliability. Many studies have been made to assess different available apheresis machines regarding procedure time, platelet yield, product quality, adverse effects and other variables (Patel et al., [18] ; Ranganathan, [20] ; Altuntas et al., [2] ; Tendulkar & Rajadhyaksha, [26] ). For example, one study showed that MCS+ could produce almost the same amount of CD34+ compared with the Cosmic Backgoround Explorer (COBE) method, whereas the latter showed more potential (Rock & Sutton, [21] ). Some study found that MCS+ could lead to less white cells reduction compared with other methods. All the comparisons were conducted in order to find a multicomponent device that could be pleasantly applied in practice. As far as we know, the majority of present studies mainly focus on the cell separator machine model improvement. As an intermittent centrifuge, MCS+ needs more accurate manipulation, hence more attention on the effective use of MCS+ including the collection method and skills, the set of all the parameters and other influence factors (Lewis et al., [11] ) should be paid. Among those factors, the set of parameters is one of the most important points. However, the studies on technical modification on the blood MCS+ are rarely reported.

The objective of this study was to evaluate the influence of technical modification on the MCS+ with the same donors, paying special attention to the whole blood processed (WBP), processing time (PT) and the number of cycles. Meanwhile, the product quality after modification was also evaluated.

This prospective study included a total of 118 eligible donors from December 2012 to April 2013. Sixty ‐ one donors underwent single ‐ dose plateletpheresis (SDP), and the other 57 donors underwent double ‐ dose plateletpheresis (DDP) before and after technical modification on the MCS+ respectively according to the manufacturer's instructions. All the procedures were carried out by the same team doctors. The same vein access was used for each donor during donation. The inter ‐ donation time was approximately 1   month. The adverse effects, such as hypocalcaemia, citrate adverse effects and vasovagal reactions, were observed during donation (Cassidy et al., [7] ; Makar et al., [12] ; Tomita et al., [27] ). The variables of WBP, PT and number of cycles, respectively, were measured.

The study was approved by the local institutional ethics committee and performed according to the Declaration of Helsinki. Informed consent was provided by each donor.

Haemonetics MCS+ (Haemonetics Corporation, Braintree, MA, USA) was used with the program version leadership development program ‐ 5.1. The operation was carried out according to the departmental standard operating procedure and the instructions of the manufacturer (Brecher & Banks, [4] ). The procedures of adjusting the parameters were listed as follows: in collection parameters, critical flow, bowl RBC volume, RBC optics volume, Dwell and Pyridinium P ‐ toluenesulfonate (PPTS) level kept the same, but the time was modified to 15   s from 30   s. In surge parameters, Fuji Surge Start Collection was modified to 98% from 95%, Fuji Surge End Collection was modified to 47% (995E, 995E2) or 45% (994CFE) to 50%, and Max Plt.Volume/Cycle was modified to 90   mL from 70 mL. In product parameters, continuous filt. loss volume and filtration loss volume were modified to 14   mL for 995E and 995E2 or 0   mL for 994CFE. For other parameters, centrifuge speed (5500   rpm), slow centri speed (5500   rpm) and plasma transfer volume (35   mL) were modified to 5600   rpm, 5600   rpm and 60   mL, respectively. In donor flow parameters, all parameters kept the same.

All statistical analysis was performed with spss version 11.0 software (SPSS Inc., Chicago, IL, USA). The values were presented as mean   ±   SD. The data were analysed using the method of paired t ‐ test, and P   <   0·05 indicated that the difference was significant.

No donor was excluded, and no severe adverse reactions on donors were found during donation. Donor characteristics were shown in Table [NaN] . For SDP, the mean platelet counting before apheresis was 221·10   ×   109   L−1 in the pre ‐ modification situation, whereas the mean platelet counting before apheresis was 221·60   ×   109   L−1 in the post ‐ modification situation. There was no significant difference between them (P   =   0·948). For DDP, there was also no significant difference in mean platelet counting before apheresis between pre ‐ and post ‐ modification situation (312·80   ×   109   L−1 vs 312·24   ×   109   L−1, P   =   0·941). Comparisons of other items also showed no significant differences.

Comparison of the basic characteristics before apheresis between the pre ‐ and post ‐ modification in the two groups

1 DDP, double ‐ dose plateletpheresis; HCT, haematocrit; PLT, platelet; SDP, single ‐ dose plateletpheresis.

As shown in Table [NaN] , the amount of WBP, PT and number of cycles in both SDP and DDP was significantly reduced after modification (all P   <   0·01). All these results suggested that the procedure parameters were greatly improved after modification of technical parameters.

Comparison of the procedure parameters between the pre ‐ and post ‐ modification in the two groups

2 DDP, double ‐ dose plateletpheresis; PT, processing time; SDP, single ‐ dose plateletpheresis; WBP, whole blood processed.

As shown in Table [NaN] , the amount of platelet in SDP was normally distributed and the mean 95% confidence interval was 2·70–2·84, indicating that there was 95% possibility that platelet amount was disturbed in 2·70   ×   109   L−1 to 2·84   ×   109   L−1. The platelet yielded met the national standard requirements that single treatment is not less than 2·5   ×   109   L−1 (Grundy et al., [10] ).

Statistical results of the platelet yield after modification in the two groups

3 DDP, double ‐ dose plateletpheresis; SD, standard deviation; SDP, single ‐ dose plateletpheresis.

The amount of platelet in DDP was also normally distributed, and the mean 95% confidence interval was 5·19–5·47, indicating that there was 95% possibility that platelet amount was disturbed in 5·19   ×   109   L−1 to 5·47   ×   109   L−1. The platelet yielded met the national standard that double treatment is not less than 5·0   ×   109   L−1 (Grundy et al., [10] ).

There were a total of 95 cases of qualified products in the study, among which 55 cases were in SDP and 40 cases were in DDP. The qualified rate of product was 80·51 % (95 in 118, Table [NaN] ). Meanwhile, the final product after modification was found to be acceptable with white blood cell contamination much below the allowable limits using MCS+.

The quality of post ‐ modification products in the two groups

4 DDP, double ‐ dose plateletpheresis; SDP, single ‐ dose plateletpheresis.

This study evaluated the improvement of procedure measures after relevant technical parameter modification on Haemonetics MCS+ with the same donors. Both SDP and DDP were used in this study. The basic characteristics of the same donors before apheresis between the pre ‐ and post ‐ modification were compared and analysed (Table [NaN] ). Besides, the quality of products was also evaluated. The results demonstrated that technical parameter modification on MCS+ could greatly reduce the PT and ensure the high ‐ quality platelet production.

It has been suggested that the whole time of procedures is greatly considered to be an important factor for both donors and physicians in blood centres (Burgstaler et al., [6] ). This study focused mainly on the time ‐ dependent variable to assess the effect of relevant technical parameter modification on MCS+. One study reported that MCS+ was the slowest when comparing with other devices including Amicus, Fresenius and CS 3000 in terms of donation time and PT (Chaudhary et al., [8] ). Another report by Bueno et al. also showed the same results: MCS+ spent the most time to produce the same and standard platelet dose compared with the Accel and Amicus (Bueno et al., [5] ). Thus, the main objective of the study was to optimise the PT of MCS+ via adjusting relevant technical parameter. The principal finding of this study demonstrated that the PT, number of cycles and the amount of WBP were significantly decreased after modification in both SDP group and DDP group (Table [NaN] ). According to those results, we can say the modification of centrifuge speed may be greatly attributed to the decreased PT and number of cycles. The decreased number of cycles after modification is also closely associated with the significantly reduced PT on the device.

For donors, the duration of procedure has been identified as the most important element in apheresis platelet in terms of donor retention (Burgstaler et al., [6] ), and this factor should be considered as one of the most important factors to evaluate an apheresis system analysing donor preference. The study by Bueno et al. ([5] ) also showed that the processing speed was the most important factor when making a donation. Our results demonstrated that the PT was significantly reduced after technical parameter adjustment, which suggested that it may increase the donor comfort. It is clear that this may greatly favours the increasing recruitment of donors at blood centres in the future. In our opinion, adverse effects related to donation were another important factor for donor retention and donor safety. Another finding of this study demonstrated that the tolerance of donors to the MCS+ after technical parameter was very good, and no severe adverse effects were found for each donor during donation.

Collection efficiency is a confusing and complex variable to assess cell separator, which could be affected by many procedure measures, such as WBP, final yield and the final platelet counting (Bueno et al., [5] ). In detail, high collection efficiency depends on the high final yield, reduced WBP and low final platelet count (Bueno et al., [5] ). In this study, it was found that there was significant reduction between the pre ‐ and post ‐ modification in terms of the amount of WBP in both the SDP and DDP groups. Thus, the improvement may also be related to an increase in collection efficiency.

Physicians are very concerned about the quality of the products, which determines the treatment effect in clinical application. The study showed that 80·51% (95 in 118) of the products after modification was qualified (Table [NaN] ). Previous study demonstrated that MCS+ was the highest capacity for leukodepletion compared with other two devices of Amicus and Accel (Bueno et al., [5] ) because of a continuous ‐ filtration technique for leukodepletion (Seghatchian & Krailadsiri, [22] ; Seghatchian et al., [23] ; Moog, [15] ). The modification on the MCS+ resulted in less than 1   ×   108   L−1 leukocyte in the selected samples, which complied with the international standard requirements (MnU ‐ B, [14] ).

Although the modification of technical parameters on MCS+ express a beneficial effect on the procedure measures, it is necessary to indicate some limitations of this study. The study has a small number of donors. In addition, the study of the other relevant procedure measures and different adverse effects associated with donation were few. Therefore, long ‐ term studies with a large population of donors are necessary to determine whether this modification will demonstrate lasting benefits and safety.

Modification of technical parameters on MCS+ could have a beneficial effect on the procedure measures and ensure a high ‐ quality platelet production. The modification may positively influence the patients' clinical outcome without increasing costs.

Q. Z. devoted to the design of this study and accompanied to X. Y. to perform the statistical analysis. L. L. carried out the study, together with Y. C., collected important background information. Q. Z. drafted the article. All authors read and approved the final article.

The authors have no competing interests.