Comparison of Spectra Optia and COBE Spectra apheresis systems performances for Red Blood Cell Exchange procedures
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1 Comparison of and COBE apheresis systems performances for Red Blood Cell Exchange procedures Jaehyup Kim MD PhD UT Southwestern Medical Center
2 COBE and COBE (Terumo BCT, Lakewood, Co) has been the mainstay cell separator for therapeutic apheresis (Terumo BCT) is the next generation separator that will eventually replace COBE We have used and COBE for therapeutic plasma exchange procedures since 2008 In December 2013, FDA approved for erythrocytopheresis
3 RBC exchange using Erythrocytopheresis procedures include: 1. Standard RBC exchange () 2. RBC depletion 3. Depletion/Exchange or Isovolemic Hemodilution - RBC exchange () protocol, unavailable on COBE, is included in the
4 Study Question Our study aimed to compare the RBCx / performance characteristics of to COBE
5 Study Design Retrospective medical chart review Study duration from January 2013 to November 2014 Patients selection criteria Received same type of procedure using both and Cases with missing data points were excluded Cases were matched based on pre-procedure hematocrits () Data was collected from procedure notes and flow sheets
6 Parameters Laboratory Procedural Pre-procedure Inlet volume Mid-procedure Target Removed RBC volume Mid-procedure Actual RBC replacement volume Post-procedure Target NS replacement volume Post-procedure Actual No. of RBC units used Pre-procedure HbS ACD-A volume Post-procedure HbS Rinseback volume Pre-procedure Platelet Total procedure run time Post-procedure Platelet FCR calculated actual Pre-procedure WBC - deviation from target Post-procedure WBC Platelet decrease (%) WBC decrease (%) Side effects
7 Results 392 RBCx procedures (45 patients) reviewed COBE - between Jan 2013 and Sep between Feb 2014 and Nov procedures (21 patients) excluded due to incomplete data or insufficient number of procedures 6 (3 and 3 ) in the same patient matched for pre-procedure selected for paired analysis 2 (1 and 1 ) in same patient selected for paired analysis
8 Results 24 patients with a diagnosis of sickle cell disease (SCD) on chronic RBC exchange protocol met criteria 13 female (average age 28.0, 20-44) 11 Male (average age 25.4, 20-34) 5 patients received s-rbcx (10 procedures) 19 patients received (114 procedures)
9 Statistical analysis Holm-Bonferroni correction was performed to reduce family-wise error rate Significance level of 0.05 was used
10 Performance comparison (1) Inlet Volume ± ± ± ± RBC Removed ± ± ± ± RBC replacement ± ± ± ± RBC Units used 7.8± ± ± ± 1.4 NS replacement 326.6± ± 97.2 NS rinseback 345.0± ± ± ± 8.9
11 Performance comparison (1) Inlet Volume ± ± ± ± RBC Removed ± ± ± ± RBC replacement ± ± ± ± RBC Units used 7.8± ± ± ± 1.4 NS replacement 326.6± ± 97.2 NS rinseback 345.0± ± ± ± 8.9
12 Performance comparison (1) Inlet Volume ± ± ± ± RBC Removed ± ± ± ± RBC replacement ± ± ± ± RBC Units used 7.8± ± ± ± 1.4 NS replacement 326.6± ± 97.2 NS rinseback 345.0± ± ± ± 8.9
13 Performance comparison (1) Inlet Volume ± ± ± ± RBC Removed ± ± ± ± RBC replacement ± ± ± ± RBC Units used 7.8± ± ± ± 1.4 NS replacement 326.6± ± 97.2 NS rinseback 345.0± ± ± ± 8.9
14 Performance comparison (1) Inlet Volume ± ± ± ± RBC Removed ± ± ± ± RBC replacement ± ± ± ± RBC Units used 7.8± ± ± ± 1.4 NS replacement 326.6± ± 97.2 NS rinseback 345.0± ± ± ± 8.9 p=0.0295
15 Performance comparison (1) Inlet Volume RBC Removed RBC replacement RBC Units used NS replacement NS rinseback ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± 125.2± 337.1± 124.2± 0 p=1.2x p=2.8x
16 Performance comparison (2) Pre 20.8± ± ± ± 3.3 Mid Target 22.2± ± 2.2 Mid Actual 21.2± ± 2.4 Post Target 31.4± ± ± ± 1.9 Post Actual 33.2± ± ± ± 2.9 Post deviation 2.4± ± ± ± 1.3
17 Performance comparison (2) Pre 20.8± ± ± ± 3.3 Mid Target 22.2± ± 2.2 Mid Actual 21.2± ± 2.4 Post Target 31.4± ± ± ± 1.9 Post Actual 33.2± ± ± ± 2.9 Post deviation 2.4± ± ± ± 1.3
18 Performance comparison (2) Pre 20.8± ± ± ± 3.3 Mid Target 22.2± ± 2.2 Mid Actual 21.2± ± 2.4 Post Target 31.4± ± ± ± 1.9 Post Actual 33.2± ± ± ± 2.9 Post deviation 2.4± ± ± ± 1.3
19 Performance comparison (2) Pre 20.8± ± ± ± 3.3 Mid Target 22.2± ± 2.2 Mid Actual 21.2± ± 2.4 Post Target 31.4± ± ± ± 1.9 Post Actual 33.2± ± ± ± 2.9 Post deviation 2.4± ± ± ± 1.3
20 Performance comparison (2) Pre 20.8± ± ± ± 3.3 Mid Target 22.2± ± 2.2 Mid Actual 21.2± ± 2.4 Post Target 31.4± ± ± ± 1.9 Post Actual 33.2± ± ± ± 2.9 Post deviation 2.4± ± ± ± 1.3
21 Performance comparison (2) Pre 20.8± ± ± ± 3.3 Mid Target 22.2± ± 2.2 Mid Actual 21.2± ± 2.4 Post Target 31.4± ± ± ± 1.9 Post Actual 33.2± ± ± ± 2.9 Post deviation 2.4± ± ± ± 1.3
22 Performance comparison (3) Total AC 293.8± ± ± ± 54.0 HbS Pre 38.4± ± ± ± 8.0 HbS Post 8.0± ± ± ± 2.6 Calculated FCR 22.2± ± ± ± 3.9 Run Time 92.8± ± ± ± 19.6
23 Performance comparison (3) Total AC 293.8± ± ± ± 54.0 HbS Pre 38.4± ± ± ± 8.0 HbS Post 8.0± ± ± ± 2.6 Calculated FCR 22.2± ± ± ± 3.9 Run Time 92.8± ± ± ± 19.6
24 Performance comparison (3) Total AC 293.8± ± ± ± 54.0 HbS Pre 38.4± ± ± ± 8.0 HbS Post 8.0± ± ± ± 2.6 Calculated FCR 22.2± ± ± ± 3.9 Run Time 92.8± ± ± ± 19.6
25 Performance comparison (3) Total AC 293.8± ± ± ± 54.0 HbS Pre 38.4± ± ± ± 8.0 HbS Post 8.0± ± ± ± 2.6 Calculated FCR 22.2± ± ± ± 3.9 Run Time 92.8± ± ± ± 19.6
26 Performance comparison (3) Total AC 293.8± ± ± ± 54.0 HbS Pre 38.4± ± ± ± 8.0 HbS Post 8.0± ± ± ± 2.6 Calculated FCR 22.2± ± ± ± 3.9 Run Time 92.8± ± ± 123.8± 15.9 p=4.7x
27 Performance comparison (4) Platelet Pre 311.2± ± ± ± 94.1 Platelet Post 155.6± ± ± ± 29.6 Platelet decrease 47.7± ± ± ± 5.7 WBC Pre 11.6± ± ± ± 3.3 WBC Post 8.5± ± ± ± 3.5 WBC decrease 16.5± ± ± ± 31.3
28 Performance comparison (4) Platelet Pre 311.2± ± ± ± 94.1 Platelet Post 155.6± ± ± ± 29.6 Platelet decrease 47.7± ± ± ± 5.7 WBC Pre 11.6± ± ± ± 3.3 WBC Post 8.5± ± ± ± 3.5 WBC decrease 16.5± ± ± ± 31.3
29 Performance comparison (4) Platelet Pre 311.2± ± ± ± 94.1 Platelet Post 155.6± ± ± ± 29.6 Platelet decrease 47.7± ± ± ± 5.7 WBC Pre 11.6± ± ± ± 3.3 WBC Post 8.5± ± ± ± 3.5 WBC decrease 16.5± ± ± ± 31.3
30 Performance comparison (4) Platelet Pre 311.2± ± ± ± 94.1 Platelet Post 155.6± ± ± ± 29.6 Platelet decrease 47.7± ± ± ± 5.7 WBC Pre 11.6± ± ± ± 3.3 WBC Post 8.5± ± ± ± 3.5 WBC decrease 16.5± ± ± ± 31.3
31 Performance comparison (4) Platelet Pre 311.2± ± ± ± 94.1 Platelet Post 155.6± ± ± ± 29.6 Platelet decrease 47.7± ± ± ± 5.7 WBC Pre 11.6± ± ± ± 3.3 WBC Post 8.5± ± ± ± 3.5 WBC decrease 16.5± ± ± ± 31.3
32 Performance comparison (4) Platelet Pre 311.2± ± ± ± 94.1 Platelet Post 155.6± ± ± ± 29.6 Platelet decrease 47.7± ± ± ± 5.7 WBC Pre 11.6± ± ± ± 3.3 WBC Post 8.5± ± ± ± 3.5 WBC decrease 16.5± ± ± ± 31.3
33 Component 2 Component 2 = 11.5% variance 3 O19 S12 S8 O5 S S9 O9 S9 O9 O14 O19 O14 S12 O14 O12 O12 S9 O12 S16 S19 S14 S14 S12 S18 S14 S16 O2 S19 O19 S19 O18 O18 S2 S17 O17 S18 S2 O8 S5 O2 O18 S2 S4 S18 O17 O7 O15 S17 S17 S8 O5 O8 O2S5 O5 S5 S8 S15 S3 O15 O4 S15 S15 O4 S7 O7 O8 O3 O6 S7 O6 S6 O3 S6 S7 S3 O11 O6 O3 O11 S6 S11 S3 S11 S1 O7 O15 O4 O1 O11 S4 O10 S11 S1 S10 O1 O1 O10 S10 O10-2 O9 O17 O13-3 S16 O16 O13 S1 O13 S13 O16 S13-4 O16 S13 S Component Component 1 = 38.9% 1 variance
34 Component 2 Component 2 = 11.5% variance Patient S O -1 O S S O Component Component 1 = 38.9% 1 variance
35 Component 2 Component 2 = 11.5% variance Patient S -1 O S O S -2 O Component Component 1 = 38.9% 1 variance
36 Component 2 Component 2 = 11.5% variance Patient O S S S O -2-3 O Component Component 1 = 38.9% 1 variance
37 Component 2 Component 2 = 11.5% variance Component Component 1 = 38.9% 1 variance
38 Side Effects Tingling Itching Hypotension (n=62) 6.5% (n=4) 4.8% (n=3) 1.6% (n=1) (n=62) 4.8% (n=3) 1.6% (n=1) 6.5% (n=4)
39 Limitations of the study Small number of standard RBC exchange procedures AC to patient information was incomplete unable to compare the difference due to lack of data for
40 Conclusions COBE and performed comparably in both s-rbcx and IHD/RBCx procedures Most procedure and laboratory parameters were comparable, except Rinseback volume significantly lower in In procedures, Lower NS replacement volume for Longer runtime for
41 Contributors UTSW Apheresis team Jeniffer Peterson, BSN RN Martin Macias, BSN RN Parkland Hospital Apheresis team Mazen El Sharif, AS Rebecca Jones, RN Marisela Ulloa, RN Jennifer Collazo Ranjit Joseph, MD Ravi Sarode, MD Karen Matevosyan, MD
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