Plasma Extraction Rate and Collection Efficiency DuringTherapeutic Plasma Exchange with Spectra Optia in

Comparison with Haemonetics MCS1Catherine Lambert,1 Marion Gericke,2 Richard Smith,2 and Cedric Hermans1*

1Cliniques Universitaires Saint-Luc, Brussels, Belgium2CaridianBCT, Europe N.V.

For therapeutic plasma exchange (TPE), continuous and intermittent flow separators are known to be efficient.

This study was undertaken to compare the performances of the Spectra Optia, a continuous flow centrifugal

apheresis system recently developed by CaridianBCT, with the Haemonetics Multicomponents System (MCS)1apheresis system based on intermittent flow centrifugation. The primary objective of the study was to compare

the time required to exchange one total plasma volume with both separators. The secondary objectives were to

determine the plasma exchange efficiency, the plasma extraction rate, the percentage of target exchange volume

achieved, and the loss of cellular components. The study involved prospectively paired comparison of 16 TPE on

each device performed in patients with chronic diseases treated with TPE. The time required to exchange 1 total

plasma volume was 182 � 36 minutes for MCS1 procedures and 100 � 20 minutes for the Spectra Optia proce-

dures (P < 0.05, all results presented as mean � standard deviation). A significantly higher plasma extraction

rate was achieved (30.2 � 4.3 vs 16.8 � 3.4 mL/min, respectively, P < 0.05), and the plasma exchange effi-

ciency was slightly better with the Spectra Optia compared with the MCS1 procedures (83.4 � 7.0 vs 80.0 �8.5%, P < 0.05). The platelet loss was significantly lower with the Spectra Optia compared with the MCS1 pro-

cedures (1.6 � 2.3 vs 7.5 � 4.2%, respectively, P < 0.05), whereas the red blood cells loss was comparable. In

conclusion, the Spectra Optia has significantly higher extraction rate and exchange efficiency than the MCS1allowing to remove the same amount of plasma in less time, by processing less blood. It also removes signifi-

cantly less platelets than the MCS1 separator. J. Clin. Apheresis 26:17–22, 2011. VVC 2010 Wiley-Liss, Inc.

Key words: apheresis; flow separator; performances

INTRODUCTION

Therapeutic plasma exchange (TPE) is an extracor-poreal blood purification technique designed to removeplasma-borne pathogenic substances. Examples of suchsubstances are pathogenic autoantibodies, immunecomplexes, endotoxins, and cholesterol-containing lipo-proteins. TPE has become a standard accepted therapyfor a variety of diseases such as thrombotic thrombocy-topenic purpura, Waldenstrom disease, MyastheniaGravis, or Guillain-Barre syndrome. In addition, it isused in indications such as drug overdose, acute sepsis,and pretransplant antibody reduction. During TPE,blood is drawn from the patient, anticoagulated,pumped into an apheresis device, which separates theblood into its cellular [platelets (PLT), white bloodcells (WBC), and red blood cells (RBC)] and cell-poor(plasma) components. The plasma to be removed iscollected into the waste or plasma remove bag, and anappropriate replacement fluid is returned to the patienttogether with the cellular components. Approximately1 to 1.5 times the calculated circulating plasma volumeof the patient is usually replaced to achieve an optimal

therapeutic effect without excessive depletion of physi-ologically important plasma constituents.

Many modern apheresis systems use centrifugation toseparate blood into its plasma and cellular components.

The information published in this paper is the result of a post-mar-

keting study sponsored by CaridianBCT Europe N.V.

*Correspondence to: Cedric Hermans, Cliniques Universitaires

Saint-Luc, Haemostasis and Thrombosis Unit, Division of Haematol-

ogy, 10 Avenue Hippocrate, B-1200 Brussels, Belgium. E-mail:

cedric.hermans@uclouvain.be.

Contract grant sponsor: Manuela Ghielli from ScEam, Medical & Sci-

entific information management and writing—Kampenhout, Belgium

Received 11 May 2010; Accepted 13 September 2010

Published online 17 November 2010 in Wiley Online Library

(wileyonlinelibrary.com).

DOI: 10.1002/jca.20271

Abbreviations used: AIM, automated interface management; pBV,

processed blood volume; PLT, platelets; RBC, red blood cells; SD,

standard deviation; TBV, total blood volume; TPE, therapeutic plasma

exchange; TPV, total plasma volume; WBC, white blood cells.

VVC 2010 Wiley-Liss, Inc.

Journal of Clinical Apheresis 26:17–22 (2011)

Among the differences in centrifugal TPE systems arewhether they use continuous or intermittent flow of thepatient blood being processed. Continuous flow systemsuse double needle venous access and usually processpatient blood more rapidly. Another important techno-logical feature is the stability and precision with whichthe systems maintain the position of the interfacebetween the plasma and cellular components [1].

The Spectra Optia1

Apheresis System is a new contin-uous flow centrifugal apheresis system CE marked forTPE, mononuclear cell collection, and RBC exchangeprotocols. Like its predecessor, the COBE Spectra, theSpectra Optia continuously separates plasma fromthe cellular constituents in a rotating belt and draws offthe separated plasma. The interface between the plasmaand the cellular elements is maintained by an automatedinterface management (AIM) system.

The superior efficacy of the Spectra Optia TPE pro-tocol over the COBE Spectra system has previouslybeen demonstrated in a nonblinded, randomized, cross-over comparative clinical study [2]. The positive resultswere confirmed later in several single arm usabilitystudies with a total of >150 procedures. Among theadvantages of the Spectra Optia system, its documentedhigher plasma exchange efficiency and lower PLT losshave been most notable [2–7].

The Haemonetics MCS1 apheresis system is basedon intermittent flow centrifugation to separate and col-lect blood components. It uses a conical centrifuge bowlthat goes through consecutive cycles of filling, separa-tion and collection. Separation, exchange and collectionof blood components are based on a calculated algorithmafter entering key patient parameters. The size and theshape of the device offer a greater portability comparedwith Spectra Optia. The system has been marketed forseveral years and is being used for various proceduresincluding PLT [8,9], RBC [10,11], mononuclear cell col-lections [12,13], and TPE [14–17].

The primary objective of this study was to compare thetime required to exchange a single patient plasma volumeon Spectra Optia and on Hemonetics MCS1. The plasmaexchange efficiency, plasma extraction rate, proportion oftarget exchange volume achieved, and loss of cell compo-nents of the two systems were also compared.

MATERIALS AND METHODS

Study Design and Patient Population

This study was a randomized, comparative cross-overstudy. Patients were randomized for the device of thefirst study treatment. The second treatment was con-ducted using the alternative device. Patients included inthe study were 18 years or older, were expected toreceive at least two sequential TPE procedures, and weremedically stable and expected to complete the studywithout serious complications. Patients were excluded

from participation if they required intensive care, werein need of a blood prime, were younger than 18 years orif they required an anticoagulant (AC) other than Antico-agulant Citrate Dextrose Solution A (AACD-A).

At the initiation of every procedure, the targetplasma volume to be exchanged was defined based onthe underlying disease, patient total plasma volume(TPV), and the hospital’s usual practice. For pairedprocedures, the target plasma volume to be exchangedwas similar for the treatments on the two devices.

Device Description

The Spectra Optia is a mobile centrifugal apheresissystem with a graphical user interface and direct imagingmethod for closed-loop feedback control of the interfaceposition. The disposable set includes a molded cassette,which houses the pumps and pressure, fluid level, and airsensors, a belt-like separation channel that is loaded intoa filler in the centrifuge chamber, and integrated bags forblood processing. The operator enters procedure andpatient parameters, controls and monitors the procedurethrough the graphical user interface. All input and pro-cess parameters are recorded and can be retrieved afterthe procedure as print out or as a data log file.

The Haemonetics MCS1 device is a small bench-top device with a disposable bowl hosting a spinningconical nucleus or cone in its middle (Latham bowl).

During the procedure, the space between the bowlwall and the cone fills up with blood which then sepa-rates into cellular and plasma components. The plasmacomponent leaves the bowl first and is collected. Out-side of the bowl, the cellular components are mixedwith replacement fluid and returned to the patient. TheLatham bowl undergoes cycles of filling and emptyingwith an extracorporeal blood volume that is defined bythe size of the Latham bowl. The size of the Lathambowl to be used for treatment was determined by thehematocrit before the procedure, the total blood volume(TBV) of the patient, the TPV to be collected, and thepatient’s tolerance to fluid replacement.

Vascular access and size of needles was aimed to besimilar with both devices (17 to 18 gauges). Albumin 5%was used as replacement fluid. The ratio of inlet blood:anticoagulant was similar (10:1) for both systems. Theapheresis nursing-staff at the study site was experienced inusing the Haemonetics MCS1 device. After training, SpectraOptia was used in routine 6 months before study start.

Assessments and Calculations

Patient’s blood was sampled immediately before andafter the TPE procedure. The complete blood cell countwas determined on a Sysmex XE-2,100 Hematology An-alyzer (Sysmex Corporation). Samples from the plasmaremoval bag were analyzed using Sysmex XE-2,100automated hematology counter for RBC, PLT, and WBC

18 Lambert et al.

Journal of Clinical Apheresis DOI 10.1002/jca

quantification and WBC differential count. In case ofinsufficient number of WBCs that could not allow WBCdifferential count by the Sysmex XE-2,100, a plasmacentrifugate was prepared. Briefly, 100 lL of plasmawere injected into a well fixed on top of a glass slide thatwas centrifuged at 500 RPM for 5 minutes. The slidewas dried then fixed with methanol and colored usingthe May-Grunwald-Giemsa coloration. Then, WBC dif-ferential was performed using optical microscope. Thismethod allows performing WBC differential for sampleswith at least 10 cells per microliter. Patient informationand target device parameter were entered into the devi-ces to preset the TPE program.

The TPV of a patient was calculated manually accord-ing to the formula TPV 5 TBV 3 (12Hct). The TBV ofa patient was determined by Spectra Optia according toNadler-Allen [18] and calculated manually according toStrauss et al. [19] for MCS1. The time to exchange oneTPV of the patient (T) was calculated by dividing theprocedure time (t) by the number of TPVs exchanged.

Plasma collection or exchange efficiency wasdefined as the total amount of plasma removed dividedby the total volume of plasma presented to the machinefor the duration of the procedure.

The amount of AC returned to the patient is indi-cated in Spectra Optia procedure reports (data logs).For MCS1, the amount of anticoagulant returned topatients has been calculated as the difference of theAC volume used and the product of AC volume andplasma exchange efficiency.

The percentages of cellular loss during a procedureare represented by the number of PLT, RBC, or WBCfound in the removal bag as a percentage of the patient’sinitial numbers of these cells in the circulation.

Statistics

In an earlier field validation study with Spectra OptiaTPE, the average time to exchange one volume ofplasma was 140 minutes with a standard deviation of 24

minutes (unpublished data). To detect a difference in thetime to exchange one patient plasma volume of 30minutes, using a two-sided 5% significance level (P <0.05) with a power of 88%, a total of 15 patients wouldbe needed. Statistical analysis was done using MicrosoftExcel 2007. Both devices were compared by two-tailed ttest using the ‘‘Paired two samples of means’’ functionin Microsoft Excel. The average values are presented asmean � standard deviation (SD).

RESULTS

Sixteen chronically ill patients were enrolled in thisstudy. The indications for TPE were

� Macroglobulinemia Waldenstrom (eight patients)� Paraproteinemic polyneuropathy (two patients)� Antibody-mediated rejections after kidney transplan-tation (two patients)

� Hyper-human leukocyte antigen sensitization beforekidney transplantation (one patient)

� Myasthenia gravis (one patient)� Refsum’s disease (one patient)� Pulmonary alveolar proteinosis (one patient)

The target plasma exchange volume prescribedranged between 0.6 and 1.2 TPV (median 0.8 TPV) forall indications. For each patient, the target TPV wasthe same for the paired procedures on the two devices.On average, 103% of the targeted TPV exchange wasachieved (between 87% and 117%). The periodbetween sequential treatments varied from 3 to 30days. The hematocrit before each treatment did not dif-fer significantly [36 � 5.26% (29–46) versus 35.3 �5.85% (26–47)].

Efficacy Analysis

Table I reports mean � SD for various procedureparameters on both, Spectra Optia and MCS1 devices.

TABLE I. Summary of Outcomes and their Statistical Significance, N 5 16

Parameter Unit

MCS1 Optia

P*Mean SD Mean SD

Time to exchange 1 TPV min 181 37 100 20 2.48 3 10210

Inlet flow rate mL/min 36.7 4.3 63 6.3 2.92 3 10212

Procedure time min 148 22 82 11 3.10 3 10211

Replacement fluid volume used mL 2456 508 2323 510 8.41 3 1026

Plasma extraction rate mL/min 16.8 3.4 30.2 4.3 2.77 3 10214

Total PLT removed (#) 6.35 3 1010 3.88 3 1010 1.20 3 1010 1.69 3 1010 1.42 3 1025

Loss as % of total body PLT % 7.0 4.3 1.6 2.3 9.04 3 1026

Total AC volume used mL 565.5 105.4 542 108.5 4.15 3 1023

Plasma exchange efficiency % 80 8.5 83.2 7.1 0.03

PV processed mL 3070.9 522.3 2958 566.2 0.03

PV removed mL 2456 506 2470 504 0.06

PV exchanged (calc.) 3 TPV 0.85 0.16 0.85 0.16 0.49

Target PV exchanged % 101 7 101 8 0.49

Total WBC removed (#) 3.80 3 107 5.31 3 107 4.00 3 107 5.29 3 107 0.47

Efficiency TPE with Spectra Optia 19

Journal of Clinical Apheresis DOI 10.1002/jca

During therapeutic procedures, 3,015 � 539 L plasmawere processed in 82 � 11 minutes on Spectra Optiaand in 148 � 22 minutes on MCS1 (all results pre-sented as mean � SD). In this time, both devicesexchanged 0.8 � 0.2 TPV. The intermittent flow aphe-resis system MCS1 requires 66 � 16 minutes longerfor this result than the continuous flow system SpectraOptia (P < 0.0001). The recommended plasma volumeto be exchanged for achieving an optimal therapeuticeffect is between 1.0 and 1.5 TPV. We studied how thetwo devices compare with each other for the exchangeof 1.0 TPV.

The time required to exchange 1.0 TPV was 182 �36 minutes for MCS1 procedures and 100 � 20minutes for the Spectra Optia procedures (P < 0.0001).This performance difference in time is mainly causedby the higher plasma extraction rate of the double-nee-dle, continuous flow apheresis system Spectra Optiawith 30.2 � 4.3 mL/min, compared with the single-needle, intermitted flow apheresis system MCS1 with16.8 � 3.4 mL/min (P < 0.0001).

The plasma exchange efficiency—thus the percent-age of plasma exchanged for albumin-containingreplacement fluid—was similar for both devices, with aslightly better performance for Spectra Optia versusMCS1, 83.4 � 7.0% and 80.0 � 8.5% (P 5 0.03),respectively. The volume of anticoagulant used wasstatistically significantly lower with Spectra Optia, 542� 108.5 mL versus 565.5 � 105.4 mL with MCS1 (P< 0.05). The same is true for the replacement fluid,2,323 � 510 mL with MCS1 versus 2,456 � 508 mLwith Spectra Optia (P < 0.05).

The AC infusion rate and the AC volume returned tothe patient are of clinical importance in the predictionand evaluation of hypocalcaemia symptoms. In bothdevices the total amount of AC used and the ratio AC:in-let blood volumes (1:10 for the study) are known. Theinfusion of the mixture of AC and blood is restricted tothe return phase at rates between 60 and 80 mL/min.

Spectra Optia limits AC infusion to 1.2 mL AC/min.With this infusion rate the likelihood for hypocalcae-mia symptoms is small. The amount of AC returned tothe patient as indicated by the device was 95 � 50 mLin Spectra Optia procedures or 1.7 � 0.7% of the inletblood volume.

MCS1 does not indicate the amount of AC returned topatients in TPE procedures. The estimated AC volumereturned to patients in MCS1 procedures was 114 � 56mL, or 2.1 � 0.8% of the inlet blood volume. The differ-ences of returned AC volume and percent of inlet volume,respectively P5 0.019 and P5 0.015 are negligible.

TPE procedures on both devices lead to limited lossof blood cell components to the waste/plasma bag. Theremoved plasma with either device did not contain anycountable number of RBC and low amounts of WBC(Table I).

The mean PLT count before each TPE was 205 �56/mm3 (116–355) and 206 � 54/mm3 (91–295). ThePLT loss, in comparison is higher in MSC1 TPE pro-cedures. Patients undergoing plasma exchange onMCS1 lost on average 7.0 � 4.3%, between 2.3% and15.6% of their total body PLT compared with SpectraOptia TPE procedures with a loss of 1.6 � 2.3%,between 0.2% and 8.1% of their total circulating PLT.

Safety Analysis

TPE procedures were completed without incidentsor serious adverse events (AE) for both devices. DuringTPE with Spectra Optia hypocalcaemia Grade 1 wasreported in 3 of 16 procedures. The symptoms, tinglinglips, face, and fingers occurred toward or at the end ofthe procedures. The symptoms were treated with cal-cium gluconate or physiologic saline (0.9% NaCl)boluses or were not treated because they occurred atthe very end of the TPE procedure. The vasovagalsymptoms in two patients on Spectra Optia, were likelynot due to the apheresis system, but to the blood accessand procedure itself. No adverse events were reportedfor MCS1 procedures.

DISCUSSION

The performances of two commercially availabletherapeutic apheresis systems were compared in theconduct of TPE procedures. The Haemonetics MCS1device was compared with the CaridianBCT SpectraOptia device, a recent successor of the COBE Spectra1

apheresis system.The objective of this study was to evaluate the time

necessary to exchange 1.0 TPV for each device. Spec-tra Optia required �1 hour and 40 minutes to exchange1.0 TPV, whereas MCS1 required 3 hours. The signifi-cantly shorter procedure time with Spectra Optia iscaused by the significantly higher plasma extractionrate, compared with MCS1. Spectra Optia uses a dou-ble needle venous access that enables a continuousflow of plasma throughout the procedure. The MCS1procedure is characterized by an intermittent flow,batch process which uses single needle access. Dualneedle continous flow has inherently higher averageinlet flow rates than single needle intermittent andtherefore shorter procedure times. The double needleprocedure may however not solely explain the morerapid TPE procedure with Spectra Optia, as the Optiasystem was also proven to be faster than COBESpectra [2,3]. A shorter procedure time is particularlyappreciable for chronically ill patients who will spendless time per procedure, and for young and workingpatients who report an increase in quality of life [20].

Although the blood separation principle in bothsystems is centrifugal the plasma exchange efficiencywas slightly but significantly higher in Spectra Optia

20 Lambert et al.

Journal of Clinical Apheresis DOI 10.1002/jca

procedures (83.2%) compared to MCS1 (80.0%).Other groups report similar and higher plasmaexchange efficiencies for Spectra Optia: 86% [3],87.9% [4], 85.8% [5], 87% [2], and median 85.4% [7].

Spectra Optia’s potential of extracting plasma per li-ter blood with very high efficiencies can be explainedby the efficient separation of the cellular and plasmafractions with high g-force and the better controlled re-moval of plasma facilitated by the AIM system. TheAIM system continuously images the interface andcontrols plasma flows so as to maintain a stable opti-mal interface position. This enables the removal of ahigher percentage of separated plasma without risk ofsignificant cellular losses. MCS1 starts and completesa TPE procedure based on initial patient and productparameters entered at the start of the procedure indif-ferent to the real-time location of the cellular/plasmainterface.

Spectra Optia procedures were significantly morePLT sparing, with a median of 10 times less loss ofcirculating PLT than MCS1 procedures (0.5% vs5.0%). With MCS1, 3 of 16 patients lost more than10% of their total body PLT. With Spectra Optia, only1 of 16 patients lost more than 5% of his total bodyPLT. Eight of 16 patients lost less than 1% of PLTwith Spectra Optia.

The predecessor of Spectra Optia, COBE Spectra,has previously been proven favorable with respect toPLT loss in comparison with MCS1 [17]. The reduc-tion in PLT loss may be important for disorders withmarkedly reduced PLT counts such as microangiopa-thies. The number of WBC in the plasma removed wascomparable for both devices. Lower WBC loss has pre-

viously been reported with COBE Spectra as comparedwith MCS1 [14].

RBC loss was at or below the limits of detection ofthe assay, thus very low for both systems. In this study,the AIM system may in part explain the favorableresults for Spectra Optia, as stable maintenance of theinterface position may help the system minimize of thePLT losses in the removed plasma.

Total amount of AC infused to the patient can becontrolled with Spectra Optia but not with MCS1. Weestimated the amount of AC infused with MCS1. Itwas lower with Spectra Optia and this result confirmedprevious studies with Spectra Optia [2–5,7]. Neverthe-less, this feature did not translate into clinical impor-tance.

Adverse events were observed in 3 of 16 patientsduring or after TPE with Spectra Optia, all with hypo-calcaemia Grade 1 and two patients with low-gradevasovagal symptoms, of which one patient with non-specific dizziness a few hours after the procedure.

The vasovagal symptoms have been minor, nonspe-cific, and did not require particular treatment and werelikely due to the blood access and the procedure itself.The fluid balance during the Spectra Optia procedureswas under tight control and close to 100%. The higherlikelihood of hypocalcaemia symptoms during SpectraOptia procedures could be explained by the continuousinfusion of citrated blood to the patient and the cumu-lative citrate concentration in the patient’s blood. TheMCS1 system works in subsequent cycles of drawingblood without AC-infusion, and reinfusion of citratedPLT concentrates in plasma replacement fluid. The vol-ume of AC infused back to the patient was similar for

Fig. 1. TPV exchanged in time. Plasma volume exchanged as a function of procedure time: at any given procedure time, Spectra Optia

(2) will have a higher plasma volume exchanged than MCS1 (2). [Color figure can be viewed in the online issue, which is available at

wileyonlinelibrary.com.]

Efficiency TPE with Spectra Optia 21

Journal of Clinical Apheresis DOI 10.1002/jca

procedures with both devices. The AC infusion rate perprocessed blood volume (pBV) was higher with theSpectra Optia device, 0.21 � 0.08 (maximal value of0.40) mL/min/Liter pBV (L pBV), and 0.14 � 0.05(maximal value of 0.23) mL/min/L pBV for MCS1.The procedures during which AE’s have been reportedresulted in rates of 0.14 to 0.23 mL/min/L pBV whichare far below the maximal value detected in SpectraOptia. The low AC-infusion rates per pBV in this setof patients, a low total AC-volume infused to thepatient and a tightly controlled fluid balance suggestthat the reasons that could have led to low-grade hypo-calcaemia in these patients might have been caused byhigher subjective sensitivities to citrate and/or by aslower citrate metabolism.

In conclusion, Spectra Optia runs with shorter proce-dure times and higher plasma extraction rates duringTPE as compared with MCS1. Higher plasmaexchange efficiencies reported earlier have been con-firmed in this study for Spectra Optia. Furthermore,significantly less PLT were counted in the SpectraOptia plasma removal bag as compared with MCS1.Finally, Spectra Optia offers better monitoring, follow-up and traceability because all parameters are recordedand computerized.

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