Therapeutic Plasma Exchange Performed Via 2 Apheresis Devices and its Impact on the Blood Profile of Hematological and Neurological Patients

Therapeutic Plasma Exchange Performed Via 2 Apheresis Devices and its Impact on the Blood Profile... Abstract Background An efficient apheresis device performs therapeutic plasma exchange (TPE) sessions in short times, while avoiding significant potential cell losses in the removed plasma. Methods To evaluate TPE performed via Optia (hereinafter, Optia) and COBE Spectra (hereinafter, COBE) apheresis devices, a paired randomized comparison study was conducted. We evaluated the device performance and its impact on cell loss in the removed plasma, as well as blood counts of patients. Results In patients with thrombotic thrombocytopenic purpura (TTP), the median platelet content of the extracted plasma was 9.5 × 1000 per µL for Optia and 33.5 × 1000 per µL for COBE (P <.001). This finding resulted in a median drop in patient platelet count of 2.4% with with Optia, compared with 5.6% with the COBE instrument (P = .04). When using albumin as replacement fluid, the median platelet content of the waste bag was comparable with both machines. However, the drop in patient platelet count with COBE was significantly higher (17.5%) compared with Optia (8.3%; P = .04). Minimal changes were observed in the hemoglobin and white blood cells of patients, undergoing sessions on both machines. Conclusion The Optia device seems to reduce significant platelet losses in patients undergoing TPE. apheresis device, TTP, therapeutic plasma exchange, complete blood counts, thrombocytopenia, neurological patients Therapeutic plasma exchange (TPE) is colloquially considered an important treatment modality and one of the most commonly performed types of therapy. It is performed to remove pathologic high-molecular-weight substances, such as autoantibodies, immune complexes, and cryoglobulins, from human plasma. TPE is considered the standard therapy for a number of diseases, including thrombotic thrombocytopenic purpura (TTP), Waldenstrom macroglobulinemia, Guillain-Barré syndrome, and myasthenia gravis. The most recent guidelines for the clinical application of therapeutic apheresis, using an evidence-based approach from the writing committee of the American Society for Apheresis (ASFA), were published in 2016.1 The TPE process involves removing whole blood through a needle or catheter and circulating it via an apheresis device, in which the blood is anticoagulated, centrifuged, and separated into its components. The separated plasma is transferred to a waste container. The principle of blood separation on the Spectra Optia (hereinafter, Optia; Terumo BCT, Inc) and COBE Spectra (hereinafter, COBE; Terumo BCT, Inc) machines is continuous-flow centrifugation, via dual vein access. The COBE machine was introduced to the transfusion center in 1999. Since then, the need for TPE has been steadily increasing. Currently, 1000 to 1200 TPE sessions are carried out annually. The Optia apheresis machine was introduced to our center in 2011. It is based on the established Trima component collection and the COBE apheresis technologies. To achieve an optimal therapeutic effect, one to one and a half it is used to report single or more of the total blood volume of patient total plasma volume is typically replaced. An efficient device must remove the appropriate volume of plasma in a short time, while avoiding severe adverse events (AEs) and significant potential cell losses in the removed plasma. Hemoglobin (Hb) and platelet loss during TPE may be of great concern, particularly in patients with TTP, who need extensive and aggressive sessions of plasma exchange. Persistent anemia and thrombocytopenia during TPE therapy could be misinterpreted in those patients as a possible relapse or as being refractory to treatment. Some studies2–4 have demonstrated significant platelet depletion with TPE, which has not been explored in textbooks or device manuals.5 Most studies, however, have reported minimal or no platelet losses. Limited data have been published comparing the performance of the Optia device with that of the COBE (which had been used widely before the introduction of the Optia). These studies have reported performance superiority of the Optia compared with the COBE.6–12 Most of these reports, however, were retrospective and did not provide accurate assessment of the procedure time—most of the spectra studies did not include reinfusion time. Also, the inlet flow rate, which essentially determines the procedure time and platelet loss, was different among various studies or was not provided. Further, none of these studies has examined the impact of machine performance on the blood profile of patients with TTP. Because of these limitations and the small number of trials, definitive conclusions could not be drawn. This study was designed to prospectively compare the performance of the Optia instrument with the COBE machine. Another objective of our study was to investigate the potential impact of the device used on the blood counts of a cohort of patients with neurological and hematological conditions, including 15 patients with TTP. Materials and Methods The study was approved by the Institutional Ethics Committee for the Protection of Human Subjects; all study subjects signed informed consent paperwork. No investigational procedures were performed. To compare the performance of the Optia with the COBE, we conducted a prospective randomized paired comparison study. A total of 67 patients with neurological and hematological conditions were assigned to have sessions using both machines. We recorded and investigated total blood volume (TBV) processed, total anticoagulant used, plasma volume removed, and total procedure time (including 8 minutes of rinse-back time with COBE) after TPE. We also examined cell loss in the removed plasma, and patients were observed for occurrence of AEs. Variables that were likely to impact the results of our study were equivalent in all paired sessions. Device errors were also recorded. Patients with vascular access problems were not analyzed, and the performance of their procedure was not evaluated. Patients Of the 67 patients enrolled in this study, 50 were being treated for neurological conditions (25 with Guillain-Barré syndrome, 10 with myasthenia gravis, 8 with chronic inflammatory demyelinating polyneuropathy, 6 with multiple sclerosis, and 1 with transverse myelitis), 15 with TTP, and 2 with hyperviscosity. Their ages ranged from 20 to 40 years, with a median of 27 years. Forty patients (59.7%) were male. Patient data, including age, sex, diagnosis, and medications used, were collected. We also recorded vital signs (pulse, blood pressure, and temperature) before and after the procedure. We investigated the impact of the apheresis device on patient peripheral blood counts, evaluating Hb, platelets, and white blood cells (WBCs). We drew peripheral blood specimens from patients immediately before and after the procedure and assessed their blood values using a calibrated cell counter (Cobas Micros hematology analyzer, F. Hoffman-La Roche, Ltd). We calculated the percentage of platelet loss among patients using the following equation: (Preapheresis platelet count–postapheresis platelet count)/preapheresis count×100% Evaluation of Patient Sessions With Albumin Being Used as the Replacement Fluid A total of 52 patients who needed at least 2 sessions within 3 days were included in this study. The evaluated paired sessions were alternating, 1 day on each device. Although a solution of 5% or 25% human serum albumin in saline is the recommended solution in the United States, we used 4% albumin in our cohort. Evaluation of Patients With TTP We studied a cohort of 15 patients with TTP who underwent TPE on the Optia and COBE platforms, from May 2011 through April 2017. Patients with clinical diagnosis of TTP associated with severely deficient (less than 10%) ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) were included in the cohort. ABO-identical fresh frozen plasma (FFP) was used as the replacement fluid in all patients. A plasma volume of 1.5 was typically exchanged in the first 3 days, followed by single-volume sessions. Sessions were performed daily until platelet and reticulocyte counts had been normal for 2 days; then, sessions were gradually tapered until being discontinued. Patients were assigned to receive 2 daily sessions, alternating 1 day on each device. The third session was performed on each machine during the tapering-off period. Plasma volume to be exchanged and inlet flow rate were set up at similar values for paired sessions. All patients were clinically stable during the evaluated sessions. Optia and COBE Apheresis Protocol for TPE Optia is a relatively new mobile continuous-flow centrifugal apheresis system used for TPE, mononuclear cell collection, and red blood cell (RBC) exchange. Optia includes a modified automated interface management system (AIM). The AIM is an optical detector that maintains the interface between the buffy coat and the separated plasma in the centrifuge channel. This instrument has also incorporated another technologic feature, namely, the automated platelet recovery system. Since the COBE instrument was first introduced into our center, many upgrades have been conducted to improve its efficiency and safety. COBE was previously described by Urdahl.13 The extracorporeal volume of the Optia kit is 185 mL, vs 270 mL for the COBE. It takes 10 minutes for the Optia and the COBE to set up the system. The Optia limits the anticoagulant (AC) infusion rate to 1.2 mL of anticoagulation per minute. To ensure consistency of variables between the 2 machines, paired sessions were performed on a designated patient at equal inlet flow rates (mL/min). The maximum whole blood flow rate was 100 mL per minute and 55 mL per minute for albumin and FFP, respectively. We removed the same volume of plasma and used the same anticoagulant citrate dextrose, formula A (ACD-A) ratios for each paired study. In this study, inlet blood was mixed with ACD-A in ratios of 10:1 in patients with TTP and 14:1 in the other patients. All patients received 10 mL of 10% calcium gluconate to prevent hypocalcemia. Plasma Exchange Protocol Citrate was used as the anticoagulant for all sessions. A double lumen central venous access was used for all procedures. Average (SD) inlet flow rates were 95 (5) mL per minute and 50 (5) mL per minute, respectively, for the albumin and FFP sessions. Volume exchanged was 1 to 1.5 and 0.8 to 1 in patients with TTP and the other patients, respectively. A fluid balance of 100% was used for all sessions on both machines. None of the procedures was terminated before the planned time. Cell Loss in the Removed Plasma To determine cell loss in the removed plasma, specimens of 5 mL from the waste bag were collected in red-top tubes. We analyzed these specimens immediately after sessions using a calibrated cell counter (COBAS Micros), measuring hematocrit (Hct), platelets, and WBCs. Evaluation of Adverse Events Patients were observed for severe and mild AEs. AEs were considered severe if they required hospitalization and were categorized as follows: 1. Citrate-related AEs, which included tingling, numbness, chills, nausea, vomiting, abdominal pain, and chest pain 2. Hypotension episodes, which were treated by saline infusions 3. Venous access–related AEs. Statistical Analysis We performed standard statistical analysis of the test results, including calculation of descriptive statistics, frequency, median, average, and mean (SD). We used the Student's t-test for comparative studies. A P value of less than .05 was considered to be statistically significant. Results Evaluation of TPE Performance on Optia and COBE Devices Analysis of sessions performed on patients with TTP The Optia instrument processed significantly lower volumes of blood (P = .03), using significantly lower ACD volumes (P = .03), compared with the COBE. The median run times with the Optia and the COBE were 115 and 125 minutes, respectively. The difference, however, was not statistically significant (P = .09) (Table 1). Table 1. Performance Evaluation of the Optia and COBE Devices in Sessions With Fresh Frozen Plasma and Albumin TPE Variable Sessions With FFP (TTP) Sessions With Albumin Optiaa COBEb Optia COBE Run time (min)  Mean (SD) 112 (27.2) 124.2 (31) 57.3 (12.2) 66.6 (19.6)  Median 115 125 56 65  P value .09 .04 Removed plasma volume (mL)  Mean 3280 (557) 3213 (781.4) 2752 (270.9) 2815 (368)  Median 3407 3151 2833.0 2822.5  P value .38 <.49 Blood volume processed (mL)  Mean (SD) 4812 (736) 5667 (994) 5536.8 (1174) 5771 (849)  Median 5193 5860 5387 5618  P value .03 .03 ACD volume (mL)  Mean (SD) 489 (84.1) 556 (85.6) 526 (104.1) 579 (141.2)  Median 486 529 457 556  P value .03 .01 TPE Variable Sessions With FFP (TTP) Sessions With Albumin Optiaa COBEb Optia COBE Run time (min)  Mean (SD) 112 (27.2) 124.2 (31) 57.3 (12.2) 66.6 (19.6)  Median 115 125 56 65  P value .09 .04 Removed plasma volume (mL)  Mean 3280 (557) 3213 (781.4) 2752 (270.9) 2815 (368)  Median 3407 3151 2833.0 2822.5  P value .38 <.49 Blood volume processed (mL)  Mean (SD) 4812 (736) 5667 (994) 5536.8 (1174) 5771 (849)  Median 5193 5860 5387 5618  P value .03 .03 ACD volume (mL)  Mean (SD) 489 (84.1) 556 (85.6) 526 (104.1) 579 (141.2)  Median 486 529 457 556  P value .03 .01 TPE, therapeutic plasma exchange; FFP, fresh frozen plasma; TTP, thrombotic thrombocytopenic purpura; ACD, anticoagulant citrate dextrose. aSpectra Optia; Terumo BCT, Inc. bCOBE Spectra; Terumo BCT, Inc. View Large Table 1. Performance Evaluation of the Optia and COBE Devices in Sessions With Fresh Frozen Plasma and Albumin TPE Variable Sessions With FFP (TTP) Sessions With Albumin Optiaa COBEb Optia COBE Run time (min)  Mean (SD) 112 (27.2) 124.2 (31) 57.3 (12.2) 66.6 (19.6)  Median 115 125 56 65  P value .09 .04 Removed plasma volume (mL)  Mean 3280 (557) 3213 (781.4) 2752 (270.9) 2815 (368)  Median 3407 3151 2833.0 2822.5  P value .38 <.49 Blood volume processed (mL)  Mean (SD) 4812 (736) 5667 (994) 5536.8 (1174) 5771 (849)  Median 5193 5860 5387 5618  P value .03 .03 ACD volume (mL)  Mean (SD) 489 (84.1) 556 (85.6) 526 (104.1) 579 (141.2)  Median 486 529 457 556  P value .03 .01 TPE Variable Sessions With FFP (TTP) Sessions With Albumin Optiaa COBEb Optia COBE Run time (min)  Mean (SD) 112 (27.2) 124.2 (31) 57.3 (12.2) 66.6 (19.6)  Median 115 125 56 65  P value .09 .04 Removed plasma volume (mL)  Mean 3280 (557) 3213 (781.4) 2752 (270.9) 2815 (368)  Median 3407 3151 2833.0 2822.5  P value .38 <.49 Blood volume processed (mL)  Mean (SD) 4812 (736) 5667 (994) 5536.8 (1174) 5771 (849)  Median 5193 5860 5387 5618  P value .03 .03 ACD volume (mL)  Mean (SD) 489 (84.1) 556 (85.6) 526 (104.1) 579 (141.2)  Median 486 529 457 556  P value .03 .01 TPE, therapeutic plasma exchange; FFP, fresh frozen plasma; TTP, thrombotic thrombocytopenic purpura; ACD, anticoagulant citrate dextrose. aSpectra Optia; Terumo BCT, Inc. bCOBE Spectra; Terumo BCT, Inc. View Large Evaluation of sessions performed using albumin as the replacement fluid A median volume of 2822.5 mL and 2833.0 mL of plasma was collected by the COBE and the Optia in 65 minutes and 56 minutes, respectively (P = .04). The median blood volume processed was 5618 mL and 5387 mL for the COBE and the Optia, respectively (P = .03). The ACD volume used with the COBE (556 mL) was significantly higher than that used with the Optia (457 mL) (P = .01). (Table 1). Analysis of the Blood Profile of Patients With TTP Platelet loss in the removed plasma and its impact on the platelet counts of patients with TTP The median platelet content of the extracted plasma was 9.5 × 1000 per µL (0–24 × 1000/µL) for the Optia vs 33.5 × 1000 per µL (0–68 × 1000/µL) for the COBE (P <.001). Further data for platelet loss in the waste bag of both machines are compiled in Table 2. Table 2. Cell Loss in Plasma Specimens From Different Patients, By Illness Type Parameter TTP Neurological Issues Hyperviscosity Optiaa COBEb Optia COBE Optia COBE Platelets × 1000/µL  Mean (SD) 10.3 (8.1) 29.9 (18.6) 40.6 (31.5) 57.4 (61.1) 158 (106) 229 (121.6)  Median (range) 9.5 (0–24) 33.5 (0–68) 40 (5–80) 38.5 (11–203) 158 (83–233) 229 (143–315)  P value <.001 .10 .23 Hematocrit %  Mean (SD) 0.07 (0.04) 0.08 (0.04) 0 0.06 (0.07) 0 0.3 (0.4)  Median (range) 0.1 (0–0.1) 0.1 (0.01–0.1) 0 (0–0.2) 0 (0–0.2) 0.3 (0.2–2.0)  P value .24 .30 .2 .20 WBCs × 1000/µL  Mean (SD) 0.13 (0.11) 0.24 (0.17) 0.140 (0.054) 0.23 (0.30) 0 0  Median (range) 0.1 (0–0.3) 0.2 (0.1–0.5) 0.1 (0.1–0.2) 0.1 (0.1–0.4) 1.1 (1.3) 1.10 (0.01–0.40)  P value .002 .23 .20 Parameter TTP Neurological Issues Hyperviscosity Optiaa COBEb Optia COBE Optia COBE Platelets × 1000/µL  Mean (SD) 10.3 (8.1) 29.9 (18.6) 40.6 (31.5) 57.4 (61.1) 158 (106) 229 (121.6)  Median (range) 9.5 (0–24) 33.5 (0–68) 40 (5–80) 38.5 (11–203) 158 (83–233) 229 (143–315)  P value <.001 .10 .23 Hematocrit %  Mean (SD) 0.07 (0.04) 0.08 (0.04) 0 0.06 (0.07) 0 0.3 (0.4)  Median (range) 0.1 (0–0.1) 0.1 (0.01–0.1) 0 (0–0.2) 0 (0–0.2) 0.3 (0.2–2.0)  P value .24 .30 .2 .20 WBCs × 1000/µL  Mean (SD) 0.13 (0.11) 0.24 (0.17) 0.140 (0.054) 0.23 (0.30) 0 0  Median (range) 0.1 (0–0.3) 0.2 (0.1–0.5) 0.1 (0.1–0.2) 0.1 (0.1–0.4) 1.1 (1.3) 1.10 (0.01–0.40)  P value .002 .23 .20 TTP, thrombotic thrombocytopenic purpura; WBCs, white blood cells. aSpectra Optia; Terumo BCT, Inc. bCOBE Spectra; Terumo BCT, Inc. View Large Table 2. Cell Loss in Plasma Specimens From Different Patients, By Illness Type Parameter TTP Neurological Issues Hyperviscosity Optiaa COBEb Optia COBE Optia COBE Platelets × 1000/µL  Mean (SD) 10.3 (8.1) 29.9 (18.6) 40.6 (31.5) 57.4 (61.1) 158 (106) 229 (121.6)  Median (range) 9.5 (0–24) 33.5 (0–68) 40 (5–80) 38.5 (11–203) 158 (83–233) 229 (143–315)  P value <.001 .10 .23 Hematocrit %  Mean (SD) 0.07 (0.04) 0.08 (0.04) 0 0.06 (0.07) 0 0.3 (0.4)  Median (range) 0.1 (0–0.1) 0.1 (0.01–0.1) 0 (0–0.2) 0 (0–0.2) 0.3 (0.2–2.0)  P value .24 .30 .2 .20 WBCs × 1000/µL  Mean (SD) 0.13 (0.11) 0.24 (0.17) 0.140 (0.054) 0.23 (0.30) 0 0  Median (range) 0.1 (0–0.3) 0.2 (0.1–0.5) 0.1 (0.1–0.2) 0.1 (0.1–0.4) 1.1 (1.3) 1.10 (0.01–0.40)  P value .002 .23 .20 Parameter TTP Neurological Issues Hyperviscosity Optiaa COBEb Optia COBE Optia COBE Platelets × 1000/µL  Mean (SD) 10.3 (8.1) 29.9 (18.6) 40.6 (31.5) 57.4 (61.1) 158 (106) 229 (121.6)  Median (range) 9.5 (0–24) 33.5 (0–68) 40 (5–80) 38.5 (11–203) 158 (83–233) 229 (143–315)  P value <.001 .10 .23 Hematocrit %  Mean (SD) 0.07 (0.04) 0.08 (0.04) 0 0.06 (0.07) 0 0.3 (0.4)  Median (range) 0.1 (0–0.1) 0.1 (0.01–0.1) 0 (0–0.2) 0 (0–0.2) 0.3 (0.2–2.0)  P value .24 .30 .2 .20 WBCs × 1000/µL  Mean (SD) 0.13 (0.11) 0.24 (0.17) 0.140 (0.054) 0.23 (0.30) 0 0  Median (range) 0.1 (0–0.3) 0.2 (0.1–0.5) 0.1 (0.1–0.2) 0.1 (0.1–0.4) 1.1 (1.3) 1.10 (0.01–0.40)  P value .002 .23 .20 TTP, thrombotic thrombocytopenic purpura; WBCs, white blood cells. aSpectra Optia; Terumo BCT, Inc. bCOBE Spectra; Terumo BCT, Inc. View Large The median percentage drop in patient platelet count was significantly higher with the COBE (5.6%), compared with the Optia (2.4%) (P = .04). This value correlated positively with volume of blood processed (r = 0.528). Changes in patient platelet counts before and after apheresis are summarized in Table 3. Table 3. Changes in Complete Blood Counts After Plasma Exchange in Sessions With Fresh Frozen Plasma and Albumin Variable Sessions With FFP (TTP) Sessions With Albumin Optiaa COBEb Optia COBE Platelets Preapheresis platelet count × 1000/µL  Mean (SD) 151.1 (107) 114.2 (93.9) 258.3 (61.3) 238.7 (44.3)  Median (range) 138 (10–434) 65 (24–391) 261 (160–340) 250 (170–300)  P value .07 .16 Postapheresis platelet count × 1000/µL  Mean (SD) 158.7 (95.7) 111.9 (81.7) 238.0 (59.4) 201.7 (34.9)  Median (range) 140.0 (24.0–398.0) 89.5 (25.0–345.0) 239.5 (148.0–328.0) 201.9 (126.0–283.0)  P value .02 .02 No. (%) of sessions with postapheresis decreased platelet counts 20 (44.4%) 28 (62.2%) NA NA NA  P value .07 No. (%) of sessions with postapheresis increased platelet counts 25 (55.6%) 17 (37.8%) NA NA NA  P value .07 NA Percentage drop in platelet count × 1000/µL  Mean (SD) 8.8 (5.3) 15.9 (10.7) 8.2 (3.8) 15.1 (10.86)  Median (range) 2.4 (0–17.8) 5.6 (0–38.6) 8.3 (3.6–13.0) 17.5 (0-27.9)  P value .04 .04 Percentage increase in platelet count × 1000/µL  Mean (SD) 37.05 (19.8_) 30.7_ (29.2_) NA NA  Median (range) 31.4 (10.0–69.0) 19.6 (0.3–82.0)  P value .26 NA Hemoglobin Preapheresis Hb, g/dL  Mean (SD) 8.10 (0.84) 8.0 (0.74) 14.43 (2.03) 14.30 (2.82)  Median (range) 8 (8.5–9) 8 (8–9) 14 (9–15) 14 (8–17)  P value .30 <.49 Postapheresis Hb, g/dL  Mean (SD) 7.90 ( 0.75) 7.40 (1.12) 14.20 ( 2.07) 13.60 ( 2.71)  Median (range) 7.9–9 (7.8) 8–9 (7.4) 14.0 (9–15) 14.0 (9–16.5)  P value .09 .30 Hb drop, g/dL  Mean (SD) 0.20 (0.26) 0.58 (0.57) 0.20 (0.27) 0.58 (0.57)  Median (range) 0–0.6 (0) 0–2 (0.6) 0–0.3 (0) 0–1.1 (0.5)  P value .03 .01 Percentage drop in Hb  Mean (SD) 2.20 (3.2) 7.50 (7.54) 1.40 (2.05) 7.50 (7.52)  Median (range) 0–4.8 7.5 (0–12.5) 0 (0–3) 2.9 (0–8)  P value .02 .01 WBCs Preapheresis WBCs count × 1000/µL  Mean (SD) 9.5 (3.2) 9.8 (5.7) 8.5 (1.2) 8.3 (1.8)  Median (range) 10.0 (10.1–14.7) 9.3 (10.3–13.5) 8.0 (8.1–13.5) 8.5 (3.7–18)  P value .40 .40 Postapheresis WBC count ×1000/µL  Mean (SD) 9.6 (3.4) 9.3 (5.2) 9.3 (4.3) 9.3 (5.2)  Median (range) 10.7 (10.5–12.5) 10.0 (8.34–13) 8.4 (7–14) 9.2 (7–13)  P value >.49 >.49 No. (%) of sessions with postapheresis decreased WBC counts 15 (33.3) 25 (55.5) 23 (44.2) 20 (38.5)  P value .03 .70 No. (%) of sessions with postapheresis increased WBC counts 18 (40) 12 (26.7) 29 (55.8) 32 (61.5)  P value .13 .70 No. (%) of sessions with no postapheresis change in WBC counts 12 (26.7) 8 (17.8) NA NA  P value .20 NA Percentage drop in WBC count (%)  Mean (SD) 9.7 (12.5) 12.8 (14.6) 9.2 (8.7) 8.1 ( 9.4)  Median (range) 6.3 (0–16.3) 4.8 (4.2–22) 4.9 (5–15) 8.2 (5–30)  P value .30 .06 Percentage increase in WBC count (%)  Mean (SD) 12.7 (15.6) 22.3 (11.2) 6.3 (2.2) 9.3 (5.3)  Median (range) 5.4 (4.2–19) 17.7 (15–35) 6.0 (3–10) 7.5 (2–8)  P value .20 .20 Variable Sessions With FFP (TTP) Sessions With Albumin Optiaa COBEb Optia COBE Platelets Preapheresis platelet count × 1000/µL  Mean (SD) 151.1 (107) 114.2 (93.9) 258.3 (61.3) 238.7 (44.3)  Median (range) 138 (10–434) 65 (24–391) 261 (160–340) 250 (170–300)  P value .07 .16 Postapheresis platelet count × 1000/µL  Mean (SD) 158.7 (95.7) 111.9 (81.7) 238.0 (59.4) 201.7 (34.9)  Median (range) 140.0 (24.0–398.0) 89.5 (25.0–345.0) 239.5 (148.0–328.0) 201.9 (126.0–283.0)  P value .02 .02 No. (%) of sessions with postapheresis decreased platelet counts 20 (44.4%) 28 (62.2%) NA NA NA  P value .07 No. (%) of sessions with postapheresis increased platelet counts 25 (55.6%) 17 (37.8%) NA NA NA  P value .07 NA Percentage drop in platelet count × 1000/µL  Mean (SD) 8.8 (5.3) 15.9 (10.7) 8.2 (3.8) 15.1 (10.86)  Median (range) 2.4 (0–17.8) 5.6 (0–38.6) 8.3 (3.6–13.0) 17.5 (0-27.9)  P value .04 .04 Percentage increase in platelet count × 1000/µL  Mean (SD) 37.05 (19.8_) 30.7_ (29.2_) NA NA  Median (range) 31.4 (10.0–69.0) 19.6 (0.3–82.0)  P value .26 NA Hemoglobin Preapheresis Hb, g/dL  Mean (SD) 8.10 (0.84) 8.0 (0.74) 14.43 (2.03) 14.30 (2.82)  Median (range) 8 (8.5–9) 8 (8–9) 14 (9–15) 14 (8–17)  P value .30 <.49 Postapheresis Hb, g/dL  Mean (SD) 7.90 ( 0.75) 7.40 (1.12) 14.20 ( 2.07) 13.60 ( 2.71)  Median (range) 7.9–9 (7.8) 8–9 (7.4) 14.0 (9–15) 14.0 (9–16.5)  P value .09 .30 Hb drop, g/dL  Mean (SD) 0.20 (0.26) 0.58 (0.57) 0.20 (0.27) 0.58 (0.57)  Median (range) 0–0.6 (0) 0–2 (0.6) 0–0.3 (0) 0–1.1 (0.5)  P value .03 .01 Percentage drop in Hb  Mean (SD) 2.20 (3.2) 7.50 (7.54) 1.40 (2.05) 7.50 (7.52)  Median (range) 0–4.8 7.5 (0–12.5) 0 (0–3) 2.9 (0–8)  P value .02 .01 WBCs Preapheresis WBCs count × 1000/µL  Mean (SD) 9.5 (3.2) 9.8 (5.7) 8.5 (1.2) 8.3 (1.8)  Median (range) 10.0 (10.1–14.7) 9.3 (10.3–13.5) 8.0 (8.1–13.5) 8.5 (3.7–18)  P value .40 .40 Postapheresis WBC count ×1000/µL  Mean (SD) 9.6 (3.4) 9.3 (5.2) 9.3 (4.3) 9.3 (5.2)  Median (range) 10.7 (10.5–12.5) 10.0 (8.34–13) 8.4 (7–14) 9.2 (7–13)  P value >.49 >.49 No. (%) of sessions with postapheresis decreased WBC counts 15 (33.3) 25 (55.5) 23 (44.2) 20 (38.5)  P value .03 .70 No. (%) of sessions with postapheresis increased WBC counts 18 (40) 12 (26.7) 29 (55.8) 32 (61.5)  P value .13 .70 No. (%) of sessions with no postapheresis change in WBC counts 12 (26.7) 8 (17.8) NA NA  P value .20 NA Percentage drop in WBC count (%)  Mean (SD) 9.7 (12.5) 12.8 (14.6) 9.2 (8.7) 8.1 ( 9.4)  Median (range) 6.3 (0–16.3) 4.8 (4.2–22) 4.9 (5–15) 8.2 (5–30)  P value .30 .06 Percentage increase in WBC count (%)  Mean (SD) 12.7 (15.6) 22.3 (11.2) 6.3 (2.2) 9.3 (5.3)  Median (range) 5.4 (4.2–19) 17.7 (15–35) 6.0 (3–10) 7.5 (2–8)  P value .20 .20 FFP, fresh frozen plasma; TTP, thrombotic thrombocytopenic purpura; NA, nonapplicable; WBC, white blood cell. aSpectra Optia; Terumo BCT, Inc. bCOBE Spectra; Terumo BCT, Inc. View Large Table 3. Changes in Complete Blood Counts After Plasma Exchange in Sessions With Fresh Frozen Plasma and Albumin Variable Sessions With FFP (TTP) Sessions With Albumin Optiaa COBEb Optia COBE Platelets Preapheresis platelet count × 1000/µL  Mean (SD) 151.1 (107) 114.2 (93.9) 258.3 (61.3) 238.7 (44.3)  Median (range) 138 (10–434) 65 (24–391) 261 (160–340) 250 (170–300)  P value .07 .16 Postapheresis platelet count × 1000/µL  Mean (SD) 158.7 (95.7) 111.9 (81.7) 238.0 (59.4) 201.7 (34.9)  Median (range) 140.0 (24.0–398.0) 89.5 (25.0–345.0) 239.5 (148.0–328.0) 201.9 (126.0–283.0)  P value .02 .02 No. (%) of sessions with postapheresis decreased platelet counts 20 (44.4%) 28 (62.2%) NA NA NA  P value .07 No. (%) of sessions with postapheresis increased platelet counts 25 (55.6%) 17 (37.8%) NA NA NA  P value .07 NA Percentage drop in platelet count × 1000/µL  Mean (SD) 8.8 (5.3) 15.9 (10.7) 8.2 (3.8) 15.1 (10.86)  Median (range) 2.4 (0–17.8) 5.6 (0–38.6) 8.3 (3.6–13.0) 17.5 (0-27.9)  P value .04 .04 Percentage increase in platelet count × 1000/µL  Mean (SD) 37.05 (19.8_) 30.7_ (29.2_) NA NA  Median (range) 31.4 (10.0–69.0) 19.6 (0.3–82.0)  P value .26 NA Hemoglobin Preapheresis Hb, g/dL  Mean (SD) 8.10 (0.84) 8.0 (0.74) 14.43 (2.03) 14.30 (2.82)  Median (range) 8 (8.5–9) 8 (8–9) 14 (9–15) 14 (8–17)  P value .30 <.49 Postapheresis Hb, g/dL  Mean (SD) 7.90 ( 0.75) 7.40 (1.12) 14.20 ( 2.07) 13.60 ( 2.71)  Median (range) 7.9–9 (7.8) 8–9 (7.4) 14.0 (9–15) 14.0 (9–16.5)  P value .09 .30 Hb drop, g/dL  Mean (SD) 0.20 (0.26) 0.58 (0.57) 0.20 (0.27) 0.58 (0.57)  Median (range) 0–0.6 (0) 0–2 (0.6) 0–0.3 (0) 0–1.1 (0.5)  P value .03 .01 Percentage drop in Hb  Mean (SD) 2.20 (3.2) 7.50 (7.54) 1.40 (2.05) 7.50 (7.52)  Median (range) 0–4.8 7.5 (0–12.5) 0 (0–3) 2.9 (0–8)  P value .02 .01 WBCs Preapheresis WBCs count × 1000/µL  Mean (SD) 9.5 (3.2) 9.8 (5.7) 8.5 (1.2) 8.3 (1.8)  Median (range) 10.0 (10.1–14.7) 9.3 (10.3–13.5) 8.0 (8.1–13.5) 8.5 (3.7–18)  P value .40 .40 Postapheresis WBC count ×1000/µL  Mean (SD) 9.6 (3.4) 9.3 (5.2) 9.3 (4.3) 9.3 (5.2)  Median (range) 10.7 (10.5–12.5) 10.0 (8.34–13) 8.4 (7–14) 9.2 (7–13)  P value >.49 >.49 No. (%) of sessions with postapheresis decreased WBC counts 15 (33.3) 25 (55.5) 23 (44.2) 20 (38.5)  P value .03 .70 No. (%) of sessions with postapheresis increased WBC counts 18 (40) 12 (26.7) 29 (55.8) 32 (61.5)  P value .13 .70 No. (%) of sessions with no postapheresis change in WBC counts 12 (26.7) 8 (17.8) NA NA  P value .20 NA Percentage drop in WBC count (%)  Mean (SD) 9.7 (12.5) 12.8 (14.6) 9.2 (8.7) 8.1 ( 9.4)  Median (range) 6.3 (0–16.3) 4.8 (4.2–22) 4.9 (5–15) 8.2 (5–30)  P value .30 .06 Percentage increase in WBC count (%)  Mean (SD) 12.7 (15.6) 22.3 (11.2) 6.3 (2.2) 9.3 (5.3)  Median (range) 5.4 (4.2–19) 17.7 (15–35) 6.0 (3–10) 7.5 (2–8)  P value .20 .20 Variable Sessions With FFP (TTP) Sessions With Albumin Optiaa COBEb Optia COBE Platelets Preapheresis platelet count × 1000/µL  Mean (SD) 151.1 (107) 114.2 (93.9) 258.3 (61.3) 238.7 (44.3)  Median (range) 138 (10–434) 65 (24–391) 261 (160–340) 250 (170–300)  P value .07 .16 Postapheresis platelet count × 1000/µL  Mean (SD) 158.7 (95.7) 111.9 (81.7) 238.0 (59.4) 201.7 (34.9)  Median (range) 140.0 (24.0–398.0) 89.5 (25.0–345.0) 239.5 (148.0–328.0) 201.9 (126.0–283.0)  P value .02 .02 No. (%) of sessions with postapheresis decreased platelet counts 20 (44.4%) 28 (62.2%) NA NA NA  P value .07 No. (%) of sessions with postapheresis increased platelet counts 25 (55.6%) 17 (37.8%) NA NA NA  P value .07 NA Percentage drop in platelet count × 1000/µL  Mean (SD) 8.8 (5.3) 15.9 (10.7) 8.2 (3.8) 15.1 (10.86)  Median (range) 2.4 (0–17.8) 5.6 (0–38.6) 8.3 (3.6–13.0) 17.5 (0-27.9)  P value .04 .04 Percentage increase in platelet count × 1000/µL  Mean (SD) 37.05 (19.8_) 30.7_ (29.2_) NA NA  Median (range) 31.4 (10.0–69.0) 19.6 (0.3–82.0)  P value .26 NA Hemoglobin Preapheresis Hb, g/dL  Mean (SD) 8.10 (0.84) 8.0 (0.74) 14.43 (2.03) 14.30 (2.82)  Median (range) 8 (8.5–9) 8 (8–9) 14 (9–15) 14 (8–17)  P value .30 <.49 Postapheresis Hb, g/dL  Mean (SD) 7.90 ( 0.75) 7.40 (1.12) 14.20 ( 2.07) 13.60 ( 2.71)  Median (range) 7.9–9 (7.8) 8–9 (7.4) 14.0 (9–15) 14.0 (9–16.5)  P value .09 .30 Hb drop, g/dL  Mean (SD) 0.20 (0.26) 0.58 (0.57) 0.20 (0.27) 0.58 (0.57)  Median (range) 0–0.6 (0) 0–2 (0.6) 0–0.3 (0) 0–1.1 (0.5)  P value .03 .01 Percentage drop in Hb  Mean (SD) 2.20 (3.2) 7.50 (7.54) 1.40 (2.05) 7.50 (7.52)  Median (range) 0–4.8 7.5 (0–12.5) 0 (0–3) 2.9 (0–8)  P value .02 .01 WBCs Preapheresis WBCs count × 1000/µL  Mean (SD) 9.5 (3.2) 9.8 (5.7) 8.5 (1.2) 8.3 (1.8)  Median (range) 10.0 (10.1–14.7) 9.3 (10.3–13.5) 8.0 (8.1–13.5) 8.5 (3.7–18)  P value .40 .40 Postapheresis WBC count ×1000/µL  Mean (SD) 9.6 (3.4) 9.3 (5.2) 9.3 (4.3) 9.3 (5.2)  Median (range) 10.7 (10.5–12.5) 10.0 (8.34–13) 8.4 (7–14) 9.2 (7–13)  P value >.49 >.49 No. (%) of sessions with postapheresis decreased WBC counts 15 (33.3) 25 (55.5) 23 (44.2) 20 (38.5)  P value .03 .70 No. (%) of sessions with postapheresis increased WBC counts 18 (40) 12 (26.7) 29 (55.8) 32 (61.5)  P value .13 .70 No. (%) of sessions with no postapheresis change in WBC counts 12 (26.7) 8 (17.8) NA NA  P value .20 NA Percentage drop in WBC count (%)  Mean (SD) 9.7 (12.5) 12.8 (14.6) 9.2 (8.7) 8.1 ( 9.4)  Median (range) 6.3 (0–16.3) 4.8 (4.2–22) 4.9 (5–15) 8.2 (5–30)  P value .30 .06 Percentage increase in WBC count (%)  Mean (SD) 12.7 (15.6) 22.3 (11.2) 6.3 (2.2) 9.3 (5.3)  Median (range) 5.4 (4.2–19) 17.7 (15–35) 6.0 (3–10) 7.5 (2–8)  P value .20 .20 FFP, fresh frozen plasma; TTP, thrombotic thrombocytopenic purpura; NA, nonapplicable; WBC, white blood cell. aSpectra Optia; Terumo BCT, Inc. bCOBE Spectra; Terumo BCT, Inc. View Large Of all the procedures we analyzed, 2 procedures resulted in a platelet loss of greater than 30% (38.5% and 36.5%). Both sessions were performed on the COBE, with 1.5 of the total blood volume being exchanged. The number of sessions with postapheresis increased platelet counts was higher with the Optia (25 sessions), compared with the COBE (17 sessions). The P value was nonsignificant (P = .07) (Table 3). Hematocrit Values of the Removed Plasma and the Impact of Those Values on the Hemoglobin of Patients With TTP The waste bag of both machines demonstrated a hematocrit value of 0.1%. However, the percentage drop in patient hemoglobin was significantly higher with the COBE, compared with the Optia (P = .02) (Table 3). White Blood Cell Loss in the Removed Plasma and the Impact of Those Values on WBC Counts of Patients With TTP The waste bag for the COBE instrument demonstrated significantly higher WBC contamination compared with the Optia (P = .002). The number of sessions with decreased WBCs counts after apheresis was significantly higher with the COBE, compared with the Optia (P = .03). We observed no significant differences in patient WBC counts between both machines (Table 3). Cell Loss in the Removed Plasma in Sessions With Albumin and the Impact of That Loss on Patient Blood Profiles Comparable peripheral blood counts were demonstrated in specimens from the waste bag of both machines. Platelet loss varied widely among various patients and was high in specimens from the waste plasma of the 2 patients with hyperviscosity (Table 2). Their postapheresis platelet counts, however, were within the normal range (287 × 1000/µL and 250 × 1000/µL.) We observed a statistically significant median platelet drop of 8.3% in patients with the Optia, compared with 17.5% using the COBE (P = .04) (Table 3). Platelet loss correlated positively with procedure time (r = 0.37), platelet preapheresis counts (r = 0.42), and volume of blood processed (r = 0.52) (Table 4). Table 4. Correlation of Platelet Loss With Apheresis Parameters in Sessions Performed With Albumin Parameter Spearman r Vallue 95% CI Pearson Correlation Coefficient (r) Preapheresis platelet count 0.42 .43–.45 Moderate Volume of blood processed 0.52 .51–.57 Strong Time of session 0.37 .39–.42 Moderate AC infusion rate 0.29 .11–.49 Weak Parameter Spearman r Vallue 95% CI Pearson Correlation Coefficient (r) Preapheresis platelet count 0.42 .43–.45 Moderate Volume of blood processed 0.52 .51–.57 Strong Time of session 0.37 .39–.42 Moderate AC infusion rate 0.29 .11–.49 Weak CI, confidence interval; AC, anticoagulant. View Large Table 4. Correlation of Platelet Loss With Apheresis Parameters in Sessions Performed With Albumin Parameter Spearman r Vallue 95% CI Pearson Correlation Coefficient (r) Preapheresis platelet count 0.42 .43–.45 Moderate Volume of blood processed 0.52 .51–.57 Strong Time of session 0.37 .39–.42 Moderate AC infusion rate 0.29 .11–.49 Weak Parameter Spearman r Vallue 95% CI Pearson Correlation Coefficient (r) Preapheresis platelet count 0.42 .43–.45 Moderate Volume of blood processed 0.52 .51–.57 Strong Time of session 0.37 .39–.42 Moderate AC infusion rate 0.29 .11–.49 Weak CI, confidence interval; AC, anticoagulant. View Large We observed minimal changes in patient Hb and WBC counts with both machines. However, the percentage drop in patient Hb was significantly higher with the COBE, compared with that of the Optia (P <.05). Postapheresis changes in patient Hb and WBCs are summarized in Table 3. Adverse Events We encountered no serious adverse effects during the study. Two mild hypotensive events occurred with the Optia machine and were rapidly alleviated by a bolus of saline. None of these events prevented the completion of any session. The Optia was less tolerant to high access and return pressures in 2 sessions. This problem was resolved, however, when the inlet flow rate was reduced. These 2 sessions were excluded from the study. Machine Errors The Optia instrument was less tolerant to high access or return pressure, with relatively frequent alarms. These alarms were solved by a software upgrade. We recorded 2 episodes of alarms caused by an inefficient venous access. Discussion Despite the fact that the Optia and COBE devices each use the same principle of operation during blood separation, the Optia demonstrated significantly superior performance, using albumin and FFP as replacement fluid. The Optia collected comparable volumes of plasma in less time, using less ACD, while processing smaller volumes of blood. The significantly higher performance of the Optia compared with the COBE has been previously documented.6–12 These findings could be attributed to the high g force of the Optia and by the stable interface position, which is maintained by the AIM detector, ultimately exchanging large volumes of plasma in short times. In a previous study,12 the newly updated Amicus instrument (Fenwal, Inc) demonstrated similar extraction efficiency to the Optia; both machines showed superior performance, compared with the COBE. When using albumin as replacement fluid, we observed similar cellular losses in specimens from the waste plasma of both machines. However, the Optia was more platelet sparing. The patient platelet drop with the COBE was significantly higher (17.5%), compared with the Optia (8.3%; P = .04). None of the patients experienced platelet loss of more than 30%, which is the level considered by the manufacturer of the Optia to be unexpected. Patient platelet counts remained within the normal range. Lower percentages of 1% and 3% with the Optia and the COBE, respectively, have been demonstrated previously. 11 Kim et al9 showed nonsignificant postapheresis cellular losses; no statistically significant differences were noted between the COBE and the Optia. Other studies demonstrated less platelet loss with the Optia device, compared with the COBE.8,11 The median platelet values that we report for the Optia (40 × 1000/µL) were higher than those reported in a previous study (9.79 × 1000/µL).7 In another study, performed in 2013, the authors demonstrated a platelet loss of 10.7 × 1000 per µL with the COBE,14 which is much lower than the values that we report (38.5 × 1000/µL). In patients with TTP, we observed significant increases in platelets in specimens from extracted plasma in the COBE instrument (33.5 × 1000/µL), compared with those of the Optia (9.5 × 1000/µL) (P <.001). This finding resulted in a median drop in patient platelet counts of 5.6% and 2.4% with the COBE and the Optia, respectively (P = .04). Two of our patients with TTP experienced platelet losses exceeding 30%, and both were performed on the COBE. Both sessions were associated with inlet flow rates of 1.1%. During these 2 sessions, 1.5 of the total blood volume was exchanged. Median percentages for platelet loss, as reported in the literature, ranged from 0 to 70%.2,5,15,16 This variation may likely be related to the different apheresis devices and, possibly, the different inlet flow rates that various study groups used. In the current study, platelet loss demonstrated a strong correlation with the volume of blood processed (r = 0.52). Platelet loss was also quite high, which possibly could be explained by our higher inlet flow rates. In sessions performed at high flow rates, the AIM detector is unable to maintain a stable interface position. This can occur as a possible consequence of the short time during which the blood is exposed to g forces. Platelet loss was evident in our 2 patients with hyperviscosity, who demonstrated the greatest platelet loss in specimens from their removed plasma. Their platelet count, however, remained within the normal range. The high-molecular-weight plasma protein, which can potentially impair platelet sedimentations, may have contributed to this significant platelet loss.5,17 Note that platelet depletion can also occur when the Hct value entered into the machine is lower than the actual value. To reduce excessive platelet loss in patients, Optia recommends that technicians increase the Hct setting by 3% as many as 3 times and that they lower the inlet flow rate to 60 mL per minute. Doing so can help maintain a stable interface throughout the run. It is also important to perform a complete blood count (CBC) right before and after the session. We observed minimal changes in patient Hb and WBC counts with both machines. Similar results were reported previously.11 None of our patients experienced severe AEs. Two minor self-limiting hypotensive episodes occurred with the Optia device. Conclusion The Optia device may help reduce significant platelet losses in hematological and neurological patients undergoing TPE. It shows superior performance, compared with the COBE device. Acknowledgments I thank the nursing staff of the Apheresis Unit at the Blood Bank of Cairo University Hospital for their technical assistance. Abbreviations Abbreviations Abbreviations TPE therapeutic plasma exchange TTP thrombotic thrombocytopenic purpura ASFA American Society for Apheresis AEs adverse events Hb hemoglobin TBV total blood volume WBCs white blood cells ADAMTS13 a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 FFP fresh frozen plasma RBC red blood cell AIM automated interface management system AC anticoagulant ACD-A anticoagulant citrate dextrose, formula A Hct hematocrit CDC complete blood count ACD anticoagulant citrate dextrose NA nonapplicable CI confidence interval. References 1. Schwartz J , Padmanabhan A , Aqui N et al. Guidelines on the use of therapeutic apheresis in clinical practice-evidence-based approach from the writing committee of the American Society for Apheresis: the seventh special issue . J Clin Apher . 2016 ; 31 ( 3 ): 149 – 162 . Google Scholar PubMed 2. Wood L , Jacobs P . The effect of serial therapeutic plasmapheresis on platelet count, coagulation factors, plasma immunoglobulin, and complement levels . J Clin Apher . 1986 ; 3 ( 2 ): 124 – 128 . Google Scholar CrossRef Search ADS PubMed 3. Sultan Y , Bussel A , Maisonneuve P , Poupeney M , Sitty X , Gajdos P . Potential danger of thrombosis after plasma exchange in the treatment of patients with immune disease . Transfusion . 1979 ; 19 ( 5 ): 588 – 593 . Google Scholar CrossRef Search ADS PubMed 4. Flaum MA , Cuneo RA , Appelbaum FR , Deisseroth AB , Engel WK , Gralnick HR . The hemostatic imbalance of plasma-exchange transfusion . Blood . 1979 ; 54 ( 3 ): 694 – 702 . Google Scholar PubMed 5. Perdue JJ , Chandler LK , Vesely SK et al. Unintentional platelet removal by plasmapheresis . J Clin Apher . 2001 ; 16 ( 2 ): 55 – 60 . Google Scholar CrossRef Search ADS PubMed 6. Douglas KW , McGarvey M , Robertson S , Taylor S , Sinclair JE . An initial single-center experience with plasma exchange on the Spectra Optia cell separator machine: 106 consecutive Optia procedures compared to 114 consecutive COBE Spectra procedures on the same patient group [abstract] . J Clin Apher . 2008 ; 23 : 17 – 18 . 7. Lefevre PA , Poullin P . Therapeutic plasma exchange with the new continuous blood flow separator Spectra Optia® (abstract) . J Clin Apher . 2008 ; 23 : 43 . 8. Hequet O , Stocco V , Assari S et al. Comparison of plasma exchange performances between Spectra Optia and COBE Spectra apheresis systems in repeated procedures considering variability and using specific statistical models . Transfus Apher Sci . 2014 ; 51 ( 1 ): 47 – 53 . Google Scholar CrossRef Search ADS PubMed 9. Kim DK , Kim S , Jeong SH , Kim HO , Kim HJ . Therapeutic plasma exchange using the Spectra Optia cell separator compared with the COBE Spectra . Ann Lab Med . 2015 ; 35 ( 5 ): 506 – 509 . Google Scholar CrossRef Search ADS PubMed 10. Roxby D , Foale A , Sumsion D , McDonald L , McArdle S . Preliminary experience using the Spectra Optia apheresis system for therapeutic plasma exchange procedures (abstract) . J Clin Apher . 2008 ; 23 : 18 – 19 . 11. Tormey CA , Peddinghaus ME , Erickson M et al. Improved plasma removal efficiency for therapeutic plasma exchange using a new apheresis platform . Transfusion . 2010 ; 50 ( 2 ): 471 – 477 . Google Scholar CrossRef Search ADS PubMed 12. Cid J , Molina JM , Mustieles MJ , Periáñez M , Lozano M . Comparison of plasma exchange procedures using three apheresis systems . Transfusion . 2015 ; 55 ( 5 ): 1001 – 1007 . Google Scholar CrossRef Search ADS PubMed 13. Urdahl SG . COBE Spectra Apheresis System: designs, protocols and results . Infusionstherapie . 1989 ; 16 ( Suppl 2 ): 30 – 43 . Google Scholar PubMed 14. Winters JL , Burgstaler EA , Gottschall JL et al. A multicenter evaluation of a new therapeutic plasma exchange procedure . Transfusion . 2013 ; 53 ( 12 ): 3269 – 3278 . Google Scholar CrossRef Search ADS PubMed 15. Lambert C , Gericke M , Smith R , Hermans C . Plasma extraction rate and collection efficiency during therapeutic plasma exchange with Spectra Optia in comparison with Haemonetics MCS+ . J Clin Apher . 2011 ; 26 ( 1 ): 17 – 22 . Google Scholar CrossRef Search ADS PubMed 16. Burgstaler EA , Pineda AA . Therapeutic plasma exchange: a paired comparison of Fresenius AS104 vs. COBE Spectra . J Clin Apher . 2001 ; 16 ( 2 ): 61 – 66 . Google Scholar CrossRef Search ADS PubMed 17. Hester J . RE: Therapeutic plasma exchange: a paired comparison of Fresenius AS104 vs. COBE Spectra . J Clin Apher . 2002 ; 17 : 49 . Google Scholar CrossRef Search ADS PubMed © American Society for Clinical Pathology 2018. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Laboratory Medicine Oxford University Press

Therapeutic Plasma Exchange Performed Via 2 Apheresis Devices and its Impact on the Blood Profile of Hematological and Neurological Patients

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© American Society for Clinical Pathology 2018. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com
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0007-5027
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1943-7730
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10.1093/labmed/lmy022
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Abstract

Abstract Background An efficient apheresis device performs therapeutic plasma exchange (TPE) sessions in short times, while avoiding significant potential cell losses in the removed plasma. Methods To evaluate TPE performed via Optia (hereinafter, Optia) and COBE Spectra (hereinafter, COBE) apheresis devices, a paired randomized comparison study was conducted. We evaluated the device performance and its impact on cell loss in the removed plasma, as well as blood counts of patients. Results In patients with thrombotic thrombocytopenic purpura (TTP), the median platelet content of the extracted plasma was 9.5 × 1000 per µL for Optia and 33.5 × 1000 per µL for COBE (P <.001). This finding resulted in a median drop in patient platelet count of 2.4% with with Optia, compared with 5.6% with the COBE instrument (P = .04). When using albumin as replacement fluid, the median platelet content of the waste bag was comparable with both machines. However, the drop in patient platelet count with COBE was significantly higher (17.5%) compared with Optia (8.3%; P = .04). Minimal changes were observed in the hemoglobin and white blood cells of patients, undergoing sessions on both machines. Conclusion The Optia device seems to reduce significant platelet losses in patients undergoing TPE. apheresis device, TTP, therapeutic plasma exchange, complete blood counts, thrombocytopenia, neurological patients Therapeutic plasma exchange (TPE) is colloquially considered an important treatment modality and one of the most commonly performed types of therapy. It is performed to remove pathologic high-molecular-weight substances, such as autoantibodies, immune complexes, and cryoglobulins, from human plasma. TPE is considered the standard therapy for a number of diseases, including thrombotic thrombocytopenic purpura (TTP), Waldenstrom macroglobulinemia, Guillain-Barré syndrome, and myasthenia gravis. The most recent guidelines for the clinical application of therapeutic apheresis, using an evidence-based approach from the writing committee of the American Society for Apheresis (ASFA), were published in 2016.1 The TPE process involves removing whole blood through a needle or catheter and circulating it via an apheresis device, in which the blood is anticoagulated, centrifuged, and separated into its components. The separated plasma is transferred to a waste container. The principle of blood separation on the Spectra Optia (hereinafter, Optia; Terumo BCT, Inc) and COBE Spectra (hereinafter, COBE; Terumo BCT, Inc) machines is continuous-flow centrifugation, via dual vein access. The COBE machine was introduced to the transfusion center in 1999. Since then, the need for TPE has been steadily increasing. Currently, 1000 to 1200 TPE sessions are carried out annually. The Optia apheresis machine was introduced to our center in 2011. It is based on the established Trima component collection and the COBE apheresis technologies. To achieve an optimal therapeutic effect, one to one and a half it is used to report single or more of the total blood volume of patient total plasma volume is typically replaced. An efficient device must remove the appropriate volume of plasma in a short time, while avoiding severe adverse events (AEs) and significant potential cell losses in the removed plasma. Hemoglobin (Hb) and platelet loss during TPE may be of great concern, particularly in patients with TTP, who need extensive and aggressive sessions of plasma exchange. Persistent anemia and thrombocytopenia during TPE therapy could be misinterpreted in those patients as a possible relapse or as being refractory to treatment. Some studies2–4 have demonstrated significant platelet depletion with TPE, which has not been explored in textbooks or device manuals.5 Most studies, however, have reported minimal or no platelet losses. Limited data have been published comparing the performance of the Optia device with that of the COBE (which had been used widely before the introduction of the Optia). These studies have reported performance superiority of the Optia compared with the COBE.6–12 Most of these reports, however, were retrospective and did not provide accurate assessment of the procedure time—most of the spectra studies did not include reinfusion time. Also, the inlet flow rate, which essentially determines the procedure time and platelet loss, was different among various studies or was not provided. Further, none of these studies has examined the impact of machine performance on the blood profile of patients with TTP. Because of these limitations and the small number of trials, definitive conclusions could not be drawn. This study was designed to prospectively compare the performance of the Optia instrument with the COBE machine. Another objective of our study was to investigate the potential impact of the device used on the blood counts of a cohort of patients with neurological and hematological conditions, including 15 patients with TTP. Materials and Methods The study was approved by the Institutional Ethics Committee for the Protection of Human Subjects; all study subjects signed informed consent paperwork. No investigational procedures were performed. To compare the performance of the Optia with the COBE, we conducted a prospective randomized paired comparison study. A total of 67 patients with neurological and hematological conditions were assigned to have sessions using both machines. We recorded and investigated total blood volume (TBV) processed, total anticoagulant used, plasma volume removed, and total procedure time (including 8 minutes of rinse-back time with COBE) after TPE. We also examined cell loss in the removed plasma, and patients were observed for occurrence of AEs. Variables that were likely to impact the results of our study were equivalent in all paired sessions. Device errors were also recorded. Patients with vascular access problems were not analyzed, and the performance of their procedure was not evaluated. Patients Of the 67 patients enrolled in this study, 50 were being treated for neurological conditions (25 with Guillain-Barré syndrome, 10 with myasthenia gravis, 8 with chronic inflammatory demyelinating polyneuropathy, 6 with multiple sclerosis, and 1 with transverse myelitis), 15 with TTP, and 2 with hyperviscosity. Their ages ranged from 20 to 40 years, with a median of 27 years. Forty patients (59.7%) were male. Patient data, including age, sex, diagnosis, and medications used, were collected. We also recorded vital signs (pulse, blood pressure, and temperature) before and after the procedure. We investigated the impact of the apheresis device on patient peripheral blood counts, evaluating Hb, platelets, and white blood cells (WBCs). We drew peripheral blood specimens from patients immediately before and after the procedure and assessed their blood values using a calibrated cell counter (Cobas Micros hematology analyzer, F. Hoffman-La Roche, Ltd). We calculated the percentage of platelet loss among patients using the following equation: (Preapheresis platelet count–postapheresis platelet count)/preapheresis count×100% Evaluation of Patient Sessions With Albumin Being Used as the Replacement Fluid A total of 52 patients who needed at least 2 sessions within 3 days were included in this study. The evaluated paired sessions were alternating, 1 day on each device. Although a solution of 5% or 25% human serum albumin in saline is the recommended solution in the United States, we used 4% albumin in our cohort. Evaluation of Patients With TTP We studied a cohort of 15 patients with TTP who underwent TPE on the Optia and COBE platforms, from May 2011 through April 2017. Patients with clinical diagnosis of TTP associated with severely deficient (less than 10%) ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) were included in the cohort. ABO-identical fresh frozen plasma (FFP) was used as the replacement fluid in all patients. A plasma volume of 1.5 was typically exchanged in the first 3 days, followed by single-volume sessions. Sessions were performed daily until platelet and reticulocyte counts had been normal for 2 days; then, sessions were gradually tapered until being discontinued. Patients were assigned to receive 2 daily sessions, alternating 1 day on each device. The third session was performed on each machine during the tapering-off period. Plasma volume to be exchanged and inlet flow rate were set up at similar values for paired sessions. All patients were clinically stable during the evaluated sessions. Optia and COBE Apheresis Protocol for TPE Optia is a relatively new mobile continuous-flow centrifugal apheresis system used for TPE, mononuclear cell collection, and red blood cell (RBC) exchange. Optia includes a modified automated interface management system (AIM). The AIM is an optical detector that maintains the interface between the buffy coat and the separated plasma in the centrifuge channel. This instrument has also incorporated another technologic feature, namely, the automated platelet recovery system. Since the COBE instrument was first introduced into our center, many upgrades have been conducted to improve its efficiency and safety. COBE was previously described by Urdahl.13 The extracorporeal volume of the Optia kit is 185 mL, vs 270 mL for the COBE. It takes 10 minutes for the Optia and the COBE to set up the system. The Optia limits the anticoagulant (AC) infusion rate to 1.2 mL of anticoagulation per minute. To ensure consistency of variables between the 2 machines, paired sessions were performed on a designated patient at equal inlet flow rates (mL/min). The maximum whole blood flow rate was 100 mL per minute and 55 mL per minute for albumin and FFP, respectively. We removed the same volume of plasma and used the same anticoagulant citrate dextrose, formula A (ACD-A) ratios for each paired study. In this study, inlet blood was mixed with ACD-A in ratios of 10:1 in patients with TTP and 14:1 in the other patients. All patients received 10 mL of 10% calcium gluconate to prevent hypocalcemia. Plasma Exchange Protocol Citrate was used as the anticoagulant for all sessions. A double lumen central venous access was used for all procedures. Average (SD) inlet flow rates were 95 (5) mL per minute and 50 (5) mL per minute, respectively, for the albumin and FFP sessions. Volume exchanged was 1 to 1.5 and 0.8 to 1 in patients with TTP and the other patients, respectively. A fluid balance of 100% was used for all sessions on both machines. None of the procedures was terminated before the planned time. Cell Loss in the Removed Plasma To determine cell loss in the removed plasma, specimens of 5 mL from the waste bag were collected in red-top tubes. We analyzed these specimens immediately after sessions using a calibrated cell counter (COBAS Micros), measuring hematocrit (Hct), platelets, and WBCs. Evaluation of Adverse Events Patients were observed for severe and mild AEs. AEs were considered severe if they required hospitalization and were categorized as follows: 1. Citrate-related AEs, which included tingling, numbness, chills, nausea, vomiting, abdominal pain, and chest pain 2. Hypotension episodes, which were treated by saline infusions 3. Venous access–related AEs. Statistical Analysis We performed standard statistical analysis of the test results, including calculation of descriptive statistics, frequency, median, average, and mean (SD). We used the Student's t-test for comparative studies. A P value of less than .05 was considered to be statistically significant. Results Evaluation of TPE Performance on Optia and COBE Devices Analysis of sessions performed on patients with TTP The Optia instrument processed significantly lower volumes of blood (P = .03), using significantly lower ACD volumes (P = .03), compared with the COBE. The median run times with the Optia and the COBE were 115 and 125 minutes, respectively. The difference, however, was not statistically significant (P = .09) (Table 1). Table 1. Performance Evaluation of the Optia and COBE Devices in Sessions With Fresh Frozen Plasma and Albumin TPE Variable Sessions With FFP (TTP) Sessions With Albumin Optiaa COBEb Optia COBE Run time (min)  Mean (SD) 112 (27.2) 124.2 (31) 57.3 (12.2) 66.6 (19.6)  Median 115 125 56 65  P value .09 .04 Removed plasma volume (mL)  Mean 3280 (557) 3213 (781.4) 2752 (270.9) 2815 (368)  Median 3407 3151 2833.0 2822.5  P value .38 <.49 Blood volume processed (mL)  Mean (SD) 4812 (736) 5667 (994) 5536.8 (1174) 5771 (849)  Median 5193 5860 5387 5618  P value .03 .03 ACD volume (mL)  Mean (SD) 489 (84.1) 556 (85.6) 526 (104.1) 579 (141.2)  Median 486 529 457 556  P value .03 .01 TPE Variable Sessions With FFP (TTP) Sessions With Albumin Optiaa COBEb Optia COBE Run time (min)  Mean (SD) 112 (27.2) 124.2 (31) 57.3 (12.2) 66.6 (19.6)  Median 115 125 56 65  P value .09 .04 Removed plasma volume (mL)  Mean 3280 (557) 3213 (781.4) 2752 (270.9) 2815 (368)  Median 3407 3151 2833.0 2822.5  P value .38 <.49 Blood volume processed (mL)  Mean (SD) 4812 (736) 5667 (994) 5536.8 (1174) 5771 (849)  Median 5193 5860 5387 5618  P value .03 .03 ACD volume (mL)  Mean (SD) 489 (84.1) 556 (85.6) 526 (104.1) 579 (141.2)  Median 486 529 457 556  P value .03 .01 TPE, therapeutic plasma exchange; FFP, fresh frozen plasma; TTP, thrombotic thrombocytopenic purpura; ACD, anticoagulant citrate dextrose. aSpectra Optia; Terumo BCT, Inc. bCOBE Spectra; Terumo BCT, Inc. View Large Table 1. Performance Evaluation of the Optia and COBE Devices in Sessions With Fresh Frozen Plasma and Albumin TPE Variable Sessions With FFP (TTP) Sessions With Albumin Optiaa COBEb Optia COBE Run time (min)  Mean (SD) 112 (27.2) 124.2 (31) 57.3 (12.2) 66.6 (19.6)  Median 115 125 56 65  P value .09 .04 Removed plasma volume (mL)  Mean 3280 (557) 3213 (781.4) 2752 (270.9) 2815 (368)  Median 3407 3151 2833.0 2822.5  P value .38 <.49 Blood volume processed (mL)  Mean (SD) 4812 (736) 5667 (994) 5536.8 (1174) 5771 (849)  Median 5193 5860 5387 5618  P value .03 .03 ACD volume (mL)  Mean (SD) 489 (84.1) 556 (85.6) 526 (104.1) 579 (141.2)  Median 486 529 457 556  P value .03 .01 TPE Variable Sessions With FFP (TTP) Sessions With Albumin Optiaa COBEb Optia COBE Run time (min)  Mean (SD) 112 (27.2) 124.2 (31) 57.3 (12.2) 66.6 (19.6)  Median 115 125 56 65  P value .09 .04 Removed plasma volume (mL)  Mean 3280 (557) 3213 (781.4) 2752 (270.9) 2815 (368)  Median 3407 3151 2833.0 2822.5  P value .38 <.49 Blood volume processed (mL)  Mean (SD) 4812 (736) 5667 (994) 5536.8 (1174) 5771 (849)  Median 5193 5860 5387 5618  P value .03 .03 ACD volume (mL)  Mean (SD) 489 (84.1) 556 (85.6) 526 (104.1) 579 (141.2)  Median 486 529 457 556  P value .03 .01 TPE, therapeutic plasma exchange; FFP, fresh frozen plasma; TTP, thrombotic thrombocytopenic purpura; ACD, anticoagulant citrate dextrose. aSpectra Optia; Terumo BCT, Inc. bCOBE Spectra; Terumo BCT, Inc. View Large Evaluation of sessions performed using albumin as the replacement fluid A median volume of 2822.5 mL and 2833.0 mL of plasma was collected by the COBE and the Optia in 65 minutes and 56 minutes, respectively (P = .04). The median blood volume processed was 5618 mL and 5387 mL for the COBE and the Optia, respectively (P = .03). The ACD volume used with the COBE (556 mL) was significantly higher than that used with the Optia (457 mL) (P = .01). (Table 1). Analysis of the Blood Profile of Patients With TTP Platelet loss in the removed plasma and its impact on the platelet counts of patients with TTP The median platelet content of the extracted plasma was 9.5 × 1000 per µL (0–24 × 1000/µL) for the Optia vs 33.5 × 1000 per µL (0–68 × 1000/µL) for the COBE (P <.001). Further data for platelet loss in the waste bag of both machines are compiled in Table 2. Table 2. Cell Loss in Plasma Specimens From Different Patients, By Illness Type Parameter TTP Neurological Issues Hyperviscosity Optiaa COBEb Optia COBE Optia COBE Platelets × 1000/µL  Mean (SD) 10.3 (8.1) 29.9 (18.6) 40.6 (31.5) 57.4 (61.1) 158 (106) 229 (121.6)  Median (range) 9.5 (0–24) 33.5 (0–68) 40 (5–80) 38.5 (11–203) 158 (83–233) 229 (143–315)  P value <.001 .10 .23 Hematocrit %  Mean (SD) 0.07 (0.04) 0.08 (0.04) 0 0.06 (0.07) 0 0.3 (0.4)  Median (range) 0.1 (0–0.1) 0.1 (0.01–0.1) 0 (0–0.2) 0 (0–0.2) 0.3 (0.2–2.0)  P value .24 .30 .2 .20 WBCs × 1000/µL  Mean (SD) 0.13 (0.11) 0.24 (0.17) 0.140 (0.054) 0.23 (0.30) 0 0  Median (range) 0.1 (0–0.3) 0.2 (0.1–0.5) 0.1 (0.1–0.2) 0.1 (0.1–0.4) 1.1 (1.3) 1.10 (0.01–0.40)  P value .002 .23 .20 Parameter TTP Neurological Issues Hyperviscosity Optiaa COBEb Optia COBE Optia COBE Platelets × 1000/µL  Mean (SD) 10.3 (8.1) 29.9 (18.6) 40.6 (31.5) 57.4 (61.1) 158 (106) 229 (121.6)  Median (range) 9.5 (0–24) 33.5 (0–68) 40 (5–80) 38.5 (11–203) 158 (83–233) 229 (143–315)  P value <.001 .10 .23 Hematocrit %  Mean (SD) 0.07 (0.04) 0.08 (0.04) 0 0.06 (0.07) 0 0.3 (0.4)  Median (range) 0.1 (0–0.1) 0.1 (0.01–0.1) 0 (0–0.2) 0 (0–0.2) 0.3 (0.2–2.0)  P value .24 .30 .2 .20 WBCs × 1000/µL  Mean (SD) 0.13 (0.11) 0.24 (0.17) 0.140 (0.054) 0.23 (0.30) 0 0  Median (range) 0.1 (0–0.3) 0.2 (0.1–0.5) 0.1 (0.1–0.2) 0.1 (0.1–0.4) 1.1 (1.3) 1.10 (0.01–0.40)  P value .002 .23 .20 TTP, thrombotic thrombocytopenic purpura; WBCs, white blood cells. aSpectra Optia; Terumo BCT, Inc. bCOBE Spectra; Terumo BCT, Inc. View Large Table 2. Cell Loss in Plasma Specimens From Different Patients, By Illness Type Parameter TTP Neurological Issues Hyperviscosity Optiaa COBEb Optia COBE Optia COBE Platelets × 1000/µL  Mean (SD) 10.3 (8.1) 29.9 (18.6) 40.6 (31.5) 57.4 (61.1) 158 (106) 229 (121.6)  Median (range) 9.5 (0–24) 33.5 (0–68) 40 (5–80) 38.5 (11–203) 158 (83–233) 229 (143–315)  P value <.001 .10 .23 Hematocrit %  Mean (SD) 0.07 (0.04) 0.08 (0.04) 0 0.06 (0.07) 0 0.3 (0.4)  Median (range) 0.1 (0–0.1) 0.1 (0.01–0.1) 0 (0–0.2) 0 (0–0.2) 0.3 (0.2–2.0)  P value .24 .30 .2 .20 WBCs × 1000/µL  Mean (SD) 0.13 (0.11) 0.24 (0.17) 0.140 (0.054) 0.23 (0.30) 0 0  Median (range) 0.1 (0–0.3) 0.2 (0.1–0.5) 0.1 (0.1–0.2) 0.1 (0.1–0.4) 1.1 (1.3) 1.10 (0.01–0.40)  P value .002 .23 .20 Parameter TTP Neurological Issues Hyperviscosity Optiaa COBEb Optia COBE Optia COBE Platelets × 1000/µL  Mean (SD) 10.3 (8.1) 29.9 (18.6) 40.6 (31.5) 57.4 (61.1) 158 (106) 229 (121.6)  Median (range) 9.5 (0–24) 33.5 (0–68) 40 (5–80) 38.5 (11–203) 158 (83–233) 229 (143–315)  P value <.001 .10 .23 Hematocrit %  Mean (SD) 0.07 (0.04) 0.08 (0.04) 0 0.06 (0.07) 0 0.3 (0.4)  Median (range) 0.1 (0–0.1) 0.1 (0.01–0.1) 0 (0–0.2) 0 (0–0.2) 0.3 (0.2–2.0)  P value .24 .30 .2 .20 WBCs × 1000/µL  Mean (SD) 0.13 (0.11) 0.24 (0.17) 0.140 (0.054) 0.23 (0.30) 0 0  Median (range) 0.1 (0–0.3) 0.2 (0.1–0.5) 0.1 (0.1–0.2) 0.1 (0.1–0.4) 1.1 (1.3) 1.10 (0.01–0.40)  P value .002 .23 .20 TTP, thrombotic thrombocytopenic purpura; WBCs, white blood cells. aSpectra Optia; Terumo BCT, Inc. bCOBE Spectra; Terumo BCT, Inc. View Large The median percentage drop in patient platelet count was significantly higher with the COBE (5.6%), compared with the Optia (2.4%) (P = .04). This value correlated positively with volume of blood processed (r = 0.528). Changes in patient platelet counts before and after apheresis are summarized in Table 3. Table 3. Changes in Complete Blood Counts After Plasma Exchange in Sessions With Fresh Frozen Plasma and Albumin Variable Sessions With FFP (TTP) Sessions With Albumin Optiaa COBEb Optia COBE Platelets Preapheresis platelet count × 1000/µL  Mean (SD) 151.1 (107) 114.2 (93.9) 258.3 (61.3) 238.7 (44.3)  Median (range) 138 (10–434) 65 (24–391) 261 (160–340) 250 (170–300)  P value .07 .16 Postapheresis platelet count × 1000/µL  Mean (SD) 158.7 (95.7) 111.9 (81.7) 238.0 (59.4) 201.7 (34.9)  Median (range) 140.0 (24.0–398.0) 89.5 (25.0–345.0) 239.5 (148.0–328.0) 201.9 (126.0–283.0)  P value .02 .02 No. (%) of sessions with postapheresis decreased platelet counts 20 (44.4%) 28 (62.2%) NA NA NA  P value .07 No. (%) of sessions with postapheresis increased platelet counts 25 (55.6%) 17 (37.8%) NA NA NA  P value .07 NA Percentage drop in platelet count × 1000/µL  Mean (SD) 8.8 (5.3) 15.9 (10.7) 8.2 (3.8) 15.1 (10.86)  Median (range) 2.4 (0–17.8) 5.6 (0–38.6) 8.3 (3.6–13.0) 17.5 (0-27.9)  P value .04 .04 Percentage increase in platelet count × 1000/µL  Mean (SD) 37.05 (19.8_) 30.7_ (29.2_) NA NA  Median (range) 31.4 (10.0–69.0) 19.6 (0.3–82.0)  P value .26 NA Hemoglobin Preapheresis Hb, g/dL  Mean (SD) 8.10 (0.84) 8.0 (0.74) 14.43 (2.03) 14.30 (2.82)  Median (range) 8 (8.5–9) 8 (8–9) 14 (9–15) 14 (8–17)  P value .30 <.49 Postapheresis Hb, g/dL  Mean (SD) 7.90 ( 0.75) 7.40 (1.12) 14.20 ( 2.07) 13.60 ( 2.71)  Median (range) 7.9–9 (7.8) 8–9 (7.4) 14.0 (9–15) 14.0 (9–16.5)  P value .09 .30 Hb drop, g/dL  Mean (SD) 0.20 (0.26) 0.58 (0.57) 0.20 (0.27) 0.58 (0.57)  Median (range) 0–0.6 (0) 0–2 (0.6) 0–0.3 (0) 0–1.1 (0.5)  P value .03 .01 Percentage drop in Hb  Mean (SD) 2.20 (3.2) 7.50 (7.54) 1.40 (2.05) 7.50 (7.52)  Median (range) 0–4.8 7.5 (0–12.5) 0 (0–3) 2.9 (0–8)  P value .02 .01 WBCs Preapheresis WBCs count × 1000/µL  Mean (SD) 9.5 (3.2) 9.8 (5.7) 8.5 (1.2) 8.3 (1.8)  Median (range) 10.0 (10.1–14.7) 9.3 (10.3–13.5) 8.0 (8.1–13.5) 8.5 (3.7–18)  P value .40 .40 Postapheresis WBC count ×1000/µL  Mean (SD) 9.6 (3.4) 9.3 (5.2) 9.3 (4.3) 9.3 (5.2)  Median (range) 10.7 (10.5–12.5) 10.0 (8.34–13) 8.4 (7–14) 9.2 (7–13)  P value >.49 >.49 No. (%) of sessions with postapheresis decreased WBC counts 15 (33.3) 25 (55.5) 23 (44.2) 20 (38.5)  P value .03 .70 No. (%) of sessions with postapheresis increased WBC counts 18 (40) 12 (26.7) 29 (55.8) 32 (61.5)  P value .13 .70 No. (%) of sessions with no postapheresis change in WBC counts 12 (26.7) 8 (17.8) NA NA  P value .20 NA Percentage drop in WBC count (%)  Mean (SD) 9.7 (12.5) 12.8 (14.6) 9.2 (8.7) 8.1 ( 9.4)  Median (range) 6.3 (0–16.3) 4.8 (4.2–22) 4.9 (5–15) 8.2 (5–30)  P value .30 .06 Percentage increase in WBC count (%)  Mean (SD) 12.7 (15.6) 22.3 (11.2) 6.3 (2.2) 9.3 (5.3)  Median (range) 5.4 (4.2–19) 17.7 (15–35) 6.0 (3–10) 7.5 (2–8)  P value .20 .20 Variable Sessions With FFP (TTP) Sessions With Albumin Optiaa COBEb Optia COBE Platelets Preapheresis platelet count × 1000/µL  Mean (SD) 151.1 (107) 114.2 (93.9) 258.3 (61.3) 238.7 (44.3)  Median (range) 138 (10–434) 65 (24–391) 261 (160–340) 250 (170–300)  P value .07 .16 Postapheresis platelet count × 1000/µL  Mean (SD) 158.7 (95.7) 111.9 (81.7) 238.0 (59.4) 201.7 (34.9)  Median (range) 140.0 (24.0–398.0) 89.5 (25.0–345.0) 239.5 (148.0–328.0) 201.9 (126.0–283.0)  P value .02 .02 No. (%) of sessions with postapheresis decreased platelet counts 20 (44.4%) 28 (62.2%) NA NA NA  P value .07 No. (%) of sessions with postapheresis increased platelet counts 25 (55.6%) 17 (37.8%) NA NA NA  P value .07 NA Percentage drop in platelet count × 1000/µL  Mean (SD) 8.8 (5.3) 15.9 (10.7) 8.2 (3.8) 15.1 (10.86)  Median (range) 2.4 (0–17.8) 5.6 (0–38.6) 8.3 (3.6–13.0) 17.5 (0-27.9)  P value .04 .04 Percentage increase in platelet count × 1000/µL  Mean (SD) 37.05 (19.8_) 30.7_ (29.2_) NA NA  Median (range) 31.4 (10.0–69.0) 19.6 (0.3–82.0)  P value .26 NA Hemoglobin Preapheresis Hb, g/dL  Mean (SD) 8.10 (0.84) 8.0 (0.74) 14.43 (2.03) 14.30 (2.82)  Median (range) 8 (8.5–9) 8 (8–9) 14 (9–15) 14 (8–17)  P value .30 <.49 Postapheresis Hb, g/dL  Mean (SD) 7.90 ( 0.75) 7.40 (1.12) 14.20 ( 2.07) 13.60 ( 2.71)  Median (range) 7.9–9 (7.8) 8–9 (7.4) 14.0 (9–15) 14.0 (9–16.5)  P value .09 .30 Hb drop, g/dL  Mean (SD) 0.20 (0.26) 0.58 (0.57) 0.20 (0.27) 0.58 (0.57)  Median (range) 0–0.6 (0) 0–2 (0.6) 0–0.3 (0) 0–1.1 (0.5)  P value .03 .01 Percentage drop in Hb  Mean (SD) 2.20 (3.2) 7.50 (7.54) 1.40 (2.05) 7.50 (7.52)  Median (range) 0–4.8 7.5 (0–12.5) 0 (0–3) 2.9 (0–8)  P value .02 .01 WBCs Preapheresis WBCs count × 1000/µL  Mean (SD) 9.5 (3.2) 9.8 (5.7) 8.5 (1.2) 8.3 (1.8)  Median (range) 10.0 (10.1–14.7) 9.3 (10.3–13.5) 8.0 (8.1–13.5) 8.5 (3.7–18)  P value .40 .40 Postapheresis WBC count ×1000/µL  Mean (SD) 9.6 (3.4) 9.3 (5.2) 9.3 (4.3) 9.3 (5.2)  Median (range) 10.7 (10.5–12.5) 10.0 (8.34–13) 8.4 (7–14) 9.2 (7–13)  P value >.49 >.49 No. (%) of sessions with postapheresis decreased WBC counts 15 (33.3) 25 (55.5) 23 (44.2) 20 (38.5)  P value .03 .70 No. (%) of sessions with postapheresis increased WBC counts 18 (40) 12 (26.7) 29 (55.8) 32 (61.5)  P value .13 .70 No. (%) of sessions with no postapheresis change in WBC counts 12 (26.7) 8 (17.8) NA NA  P value .20 NA Percentage drop in WBC count (%)  Mean (SD) 9.7 (12.5) 12.8 (14.6) 9.2 (8.7) 8.1 ( 9.4)  Median (range) 6.3 (0–16.3) 4.8 (4.2–22) 4.9 (5–15) 8.2 (5–30)  P value .30 .06 Percentage increase in WBC count (%)  Mean (SD) 12.7 (15.6) 22.3 (11.2) 6.3 (2.2) 9.3 (5.3)  Median (range) 5.4 (4.2–19) 17.7 (15–35) 6.0 (3–10) 7.5 (2–8)  P value .20 .20 FFP, fresh frozen plasma; TTP, thrombotic thrombocytopenic purpura; NA, nonapplicable; WBC, white blood cell. aSpectra Optia; Terumo BCT, Inc. bCOBE Spectra; Terumo BCT, Inc. View Large Table 3. Changes in Complete Blood Counts After Plasma Exchange in Sessions With Fresh Frozen Plasma and Albumin Variable Sessions With FFP (TTP) Sessions With Albumin Optiaa COBEb Optia COBE Platelets Preapheresis platelet count × 1000/µL  Mean (SD) 151.1 (107) 114.2 (93.9) 258.3 (61.3) 238.7 (44.3)  Median (range) 138 (10–434) 65 (24–391) 261 (160–340) 250 (170–300)  P value .07 .16 Postapheresis platelet count × 1000/µL  Mean (SD) 158.7 (95.7) 111.9 (81.7) 238.0 (59.4) 201.7 (34.9)  Median (range) 140.0 (24.0–398.0) 89.5 (25.0–345.0) 239.5 (148.0–328.0) 201.9 (126.0–283.0)  P value .02 .02 No. (%) of sessions with postapheresis decreased platelet counts 20 (44.4%) 28 (62.2%) NA NA NA  P value .07 No. (%) of sessions with postapheresis increased platelet counts 25 (55.6%) 17 (37.8%) NA NA NA  P value .07 NA Percentage drop in platelet count × 1000/µL  Mean (SD) 8.8 (5.3) 15.9 (10.7) 8.2 (3.8) 15.1 (10.86)  Median (range) 2.4 (0–17.8) 5.6 (0–38.6) 8.3 (3.6–13.0) 17.5 (0-27.9)  P value .04 .04 Percentage increase in platelet count × 1000/µL  Mean (SD) 37.05 (19.8_) 30.7_ (29.2_) NA NA  Median (range) 31.4 (10.0–69.0) 19.6 (0.3–82.0)  P value .26 NA Hemoglobin Preapheresis Hb, g/dL  Mean (SD) 8.10 (0.84) 8.0 (0.74) 14.43 (2.03) 14.30 (2.82)  Median (range) 8 (8.5–9) 8 (8–9) 14 (9–15) 14 (8–17)  P value .30 <.49 Postapheresis Hb, g/dL  Mean (SD) 7.90 ( 0.75) 7.40 (1.12) 14.20 ( 2.07) 13.60 ( 2.71)  Median (range) 7.9–9 (7.8) 8–9 (7.4) 14.0 (9–15) 14.0 (9–16.5)  P value .09 .30 Hb drop, g/dL  Mean (SD) 0.20 (0.26) 0.58 (0.57) 0.20 (0.27) 0.58 (0.57)  Median (range) 0–0.6 (0) 0–2 (0.6) 0–0.3 (0) 0–1.1 (0.5)  P value .03 .01 Percentage drop in Hb  Mean (SD) 2.20 (3.2) 7.50 (7.54) 1.40 (2.05) 7.50 (7.52)  Median (range) 0–4.8 7.5 (0–12.5) 0 (0–3) 2.9 (0–8)  P value .02 .01 WBCs Preapheresis WBCs count × 1000/µL  Mean (SD) 9.5 (3.2) 9.8 (5.7) 8.5 (1.2) 8.3 (1.8)  Median (range) 10.0 (10.1–14.7) 9.3 (10.3–13.5) 8.0 (8.1–13.5) 8.5 (3.7–18)  P value .40 .40 Postapheresis WBC count ×1000/µL  Mean (SD) 9.6 (3.4) 9.3 (5.2) 9.3 (4.3) 9.3 (5.2)  Median (range) 10.7 (10.5–12.5) 10.0 (8.34–13) 8.4 (7–14) 9.2 (7–13)  P value >.49 >.49 No. (%) of sessions with postapheresis decreased WBC counts 15 (33.3) 25 (55.5) 23 (44.2) 20 (38.5)  P value .03 .70 No. (%) of sessions with postapheresis increased WBC counts 18 (40) 12 (26.7) 29 (55.8) 32 (61.5)  P value .13 .70 No. (%) of sessions with no postapheresis change in WBC counts 12 (26.7) 8 (17.8) NA NA  P value .20 NA Percentage drop in WBC count (%)  Mean (SD) 9.7 (12.5) 12.8 (14.6) 9.2 (8.7) 8.1 ( 9.4)  Median (range) 6.3 (0–16.3) 4.8 (4.2–22) 4.9 (5–15) 8.2 (5–30)  P value .30 .06 Percentage increase in WBC count (%)  Mean (SD) 12.7 (15.6) 22.3 (11.2) 6.3 (2.2) 9.3 (5.3)  Median (range) 5.4 (4.2–19) 17.7 (15–35) 6.0 (3–10) 7.5 (2–8)  P value .20 .20 Variable Sessions With FFP (TTP) Sessions With Albumin Optiaa COBEb Optia COBE Platelets Preapheresis platelet count × 1000/µL  Mean (SD) 151.1 (107) 114.2 (93.9) 258.3 (61.3) 238.7 (44.3)  Median (range) 138 (10–434) 65 (24–391) 261 (160–340) 250 (170–300)  P value .07 .16 Postapheresis platelet count × 1000/µL  Mean (SD) 158.7 (95.7) 111.9 (81.7) 238.0 (59.4) 201.7 (34.9)  Median (range) 140.0 (24.0–398.0) 89.5 (25.0–345.0) 239.5 (148.0–328.0) 201.9 (126.0–283.0)  P value .02 .02 No. (%) of sessions with postapheresis decreased platelet counts 20 (44.4%) 28 (62.2%) NA NA NA  P value .07 No. (%) of sessions with postapheresis increased platelet counts 25 (55.6%) 17 (37.8%) NA NA NA  P value .07 NA Percentage drop in platelet count × 1000/µL  Mean (SD) 8.8 (5.3) 15.9 (10.7) 8.2 (3.8) 15.1 (10.86)  Median (range) 2.4 (0–17.8) 5.6 (0–38.6) 8.3 (3.6–13.0) 17.5 (0-27.9)  P value .04 .04 Percentage increase in platelet count × 1000/µL  Mean (SD) 37.05 (19.8_) 30.7_ (29.2_) NA NA  Median (range) 31.4 (10.0–69.0) 19.6 (0.3–82.0)  P value .26 NA Hemoglobin Preapheresis Hb, g/dL  Mean (SD) 8.10 (0.84) 8.0 (0.74) 14.43 (2.03) 14.30 (2.82)  Median (range) 8 (8.5–9) 8 (8–9) 14 (9–15) 14 (8–17)  P value .30 <.49 Postapheresis Hb, g/dL  Mean (SD) 7.90 ( 0.75) 7.40 (1.12) 14.20 ( 2.07) 13.60 ( 2.71)  Median (range) 7.9–9 (7.8) 8–9 (7.4) 14.0 (9–15) 14.0 (9–16.5)  P value .09 .30 Hb drop, g/dL  Mean (SD) 0.20 (0.26) 0.58 (0.57) 0.20 (0.27) 0.58 (0.57)  Median (range) 0–0.6 (0) 0–2 (0.6) 0–0.3 (0) 0–1.1 (0.5)  P value .03 .01 Percentage drop in Hb  Mean (SD) 2.20 (3.2) 7.50 (7.54) 1.40 (2.05) 7.50 (7.52)  Median (range) 0–4.8 7.5 (0–12.5) 0 (0–3) 2.9 (0–8)  P value .02 .01 WBCs Preapheresis WBCs count × 1000/µL  Mean (SD) 9.5 (3.2) 9.8 (5.7) 8.5 (1.2) 8.3 (1.8)  Median (range) 10.0 (10.1–14.7) 9.3 (10.3–13.5) 8.0 (8.1–13.5) 8.5 (3.7–18)  P value .40 .40 Postapheresis WBC count ×1000/µL  Mean (SD) 9.6 (3.4) 9.3 (5.2) 9.3 (4.3) 9.3 (5.2)  Median (range) 10.7 (10.5–12.5) 10.0 (8.34–13) 8.4 (7–14) 9.2 (7–13)  P value >.49 >.49 No. (%) of sessions with postapheresis decreased WBC counts 15 (33.3) 25 (55.5) 23 (44.2) 20 (38.5)  P value .03 .70 No. (%) of sessions with postapheresis increased WBC counts 18 (40) 12 (26.7) 29 (55.8) 32 (61.5)  P value .13 .70 No. (%) of sessions with no postapheresis change in WBC counts 12 (26.7) 8 (17.8) NA NA  P value .20 NA Percentage drop in WBC count (%)  Mean (SD) 9.7 (12.5) 12.8 (14.6) 9.2 (8.7) 8.1 ( 9.4)  Median (range) 6.3 (0–16.3) 4.8 (4.2–22) 4.9 (5–15) 8.2 (5–30)  P value .30 .06 Percentage increase in WBC count (%)  Mean (SD) 12.7 (15.6) 22.3 (11.2) 6.3 (2.2) 9.3 (5.3)  Median (range) 5.4 (4.2–19) 17.7 (15–35) 6.0 (3–10) 7.5 (2–8)  P value .20 .20 FFP, fresh frozen plasma; TTP, thrombotic thrombocytopenic purpura; NA, nonapplicable; WBC, white blood cell. aSpectra Optia; Terumo BCT, Inc. bCOBE Spectra; Terumo BCT, Inc. View Large Of all the procedures we analyzed, 2 procedures resulted in a platelet loss of greater than 30% (38.5% and 36.5%). Both sessions were performed on the COBE, with 1.5 of the total blood volume being exchanged. The number of sessions with postapheresis increased platelet counts was higher with the Optia (25 sessions), compared with the COBE (17 sessions). The P value was nonsignificant (P = .07) (Table 3). Hematocrit Values of the Removed Plasma and the Impact of Those Values on the Hemoglobin of Patients With TTP The waste bag of both machines demonstrated a hematocrit value of 0.1%. However, the percentage drop in patient hemoglobin was significantly higher with the COBE, compared with the Optia (P = .02) (Table 3). White Blood Cell Loss in the Removed Plasma and the Impact of Those Values on WBC Counts of Patients With TTP The waste bag for the COBE instrument demonstrated significantly higher WBC contamination compared with the Optia (P = .002). The number of sessions with decreased WBCs counts after apheresis was significantly higher with the COBE, compared with the Optia (P = .03). We observed no significant differences in patient WBC counts between both machines (Table 3). Cell Loss in the Removed Plasma in Sessions With Albumin and the Impact of That Loss on Patient Blood Profiles Comparable peripheral blood counts were demonstrated in specimens from the waste bag of both machines. Platelet loss varied widely among various patients and was high in specimens from the waste plasma of the 2 patients with hyperviscosity (Table 2). Their postapheresis platelet counts, however, were within the normal range (287 × 1000/µL and 250 × 1000/µL.) We observed a statistically significant median platelet drop of 8.3% in patients with the Optia, compared with 17.5% using the COBE (P = .04) (Table 3). Platelet loss correlated positively with procedure time (r = 0.37), platelet preapheresis counts (r = 0.42), and volume of blood processed (r = 0.52) (Table 4). Table 4. Correlation of Platelet Loss With Apheresis Parameters in Sessions Performed With Albumin Parameter Spearman r Vallue 95% CI Pearson Correlation Coefficient (r) Preapheresis platelet count 0.42 .43–.45 Moderate Volume of blood processed 0.52 .51–.57 Strong Time of session 0.37 .39–.42 Moderate AC infusion rate 0.29 .11–.49 Weak Parameter Spearman r Vallue 95% CI Pearson Correlation Coefficient (r) Preapheresis platelet count 0.42 .43–.45 Moderate Volume of blood processed 0.52 .51–.57 Strong Time of session 0.37 .39–.42 Moderate AC infusion rate 0.29 .11–.49 Weak CI, confidence interval; AC, anticoagulant. View Large Table 4. Correlation of Platelet Loss With Apheresis Parameters in Sessions Performed With Albumin Parameter Spearman r Vallue 95% CI Pearson Correlation Coefficient (r) Preapheresis platelet count 0.42 .43–.45 Moderate Volume of blood processed 0.52 .51–.57 Strong Time of session 0.37 .39–.42 Moderate AC infusion rate 0.29 .11–.49 Weak Parameter Spearman r Vallue 95% CI Pearson Correlation Coefficient (r) Preapheresis platelet count 0.42 .43–.45 Moderate Volume of blood processed 0.52 .51–.57 Strong Time of session 0.37 .39–.42 Moderate AC infusion rate 0.29 .11–.49 Weak CI, confidence interval; AC, anticoagulant. View Large We observed minimal changes in patient Hb and WBC counts with both machines. However, the percentage drop in patient Hb was significantly higher with the COBE, compared with that of the Optia (P <.05). Postapheresis changes in patient Hb and WBCs are summarized in Table 3. Adverse Events We encountered no serious adverse effects during the study. Two mild hypotensive events occurred with the Optia machine and were rapidly alleviated by a bolus of saline. None of these events prevented the completion of any session. The Optia was less tolerant to high access and return pressures in 2 sessions. This problem was resolved, however, when the inlet flow rate was reduced. These 2 sessions were excluded from the study. Machine Errors The Optia instrument was less tolerant to high access or return pressure, with relatively frequent alarms. These alarms were solved by a software upgrade. We recorded 2 episodes of alarms caused by an inefficient venous access. Discussion Despite the fact that the Optia and COBE devices each use the same principle of operation during blood separation, the Optia demonstrated significantly superior performance, using albumin and FFP as replacement fluid. The Optia collected comparable volumes of plasma in less time, using less ACD, while processing smaller volumes of blood. The significantly higher performance of the Optia compared with the COBE has been previously documented.6–12 These findings could be attributed to the high g force of the Optia and by the stable interface position, which is maintained by the AIM detector, ultimately exchanging large volumes of plasma in short times. In a previous study,12 the newly updated Amicus instrument (Fenwal, Inc) demonstrated similar extraction efficiency to the Optia; both machines showed superior performance, compared with the COBE. When using albumin as replacement fluid, we observed similar cellular losses in specimens from the waste plasma of both machines. However, the Optia was more platelet sparing. The patient platelet drop with the COBE was significantly higher (17.5%), compared with the Optia (8.3%; P = .04). None of the patients experienced platelet loss of more than 30%, which is the level considered by the manufacturer of the Optia to be unexpected. Patient platelet counts remained within the normal range. Lower percentages of 1% and 3% with the Optia and the COBE, respectively, have been demonstrated previously. 11 Kim et al9 showed nonsignificant postapheresis cellular losses; no statistically significant differences were noted between the COBE and the Optia. Other studies demonstrated less platelet loss with the Optia device, compared with the COBE.8,11 The median platelet values that we report for the Optia (40 × 1000/µL) were higher than those reported in a previous study (9.79 × 1000/µL).7 In another study, performed in 2013, the authors demonstrated a platelet loss of 10.7 × 1000 per µL with the COBE,14 which is much lower than the values that we report (38.5 × 1000/µL). In patients with TTP, we observed significant increases in platelets in specimens from extracted plasma in the COBE instrument (33.5 × 1000/µL), compared with those of the Optia (9.5 × 1000/µL) (P <.001). This finding resulted in a median drop in patient platelet counts of 5.6% and 2.4% with the COBE and the Optia, respectively (P = .04). Two of our patients with TTP experienced platelet losses exceeding 30%, and both were performed on the COBE. Both sessions were associated with inlet flow rates of 1.1%. During these 2 sessions, 1.5 of the total blood volume was exchanged. Median percentages for platelet loss, as reported in the literature, ranged from 0 to 70%.2,5,15,16 This variation may likely be related to the different apheresis devices and, possibly, the different inlet flow rates that various study groups used. In the current study, platelet loss demonstrated a strong correlation with the volume of blood processed (r = 0.52). Platelet loss was also quite high, which possibly could be explained by our higher inlet flow rates. In sessions performed at high flow rates, the AIM detector is unable to maintain a stable interface position. This can occur as a possible consequence of the short time during which the blood is exposed to g forces. Platelet loss was evident in our 2 patients with hyperviscosity, who demonstrated the greatest platelet loss in specimens from their removed plasma. Their platelet count, however, remained within the normal range. The high-molecular-weight plasma protein, which can potentially impair platelet sedimentations, may have contributed to this significant platelet loss.5,17 Note that platelet depletion can also occur when the Hct value entered into the machine is lower than the actual value. To reduce excessive platelet loss in patients, Optia recommends that technicians increase the Hct setting by 3% as many as 3 times and that they lower the inlet flow rate to 60 mL per minute. Doing so can help maintain a stable interface throughout the run. It is also important to perform a complete blood count (CBC) right before and after the session. We observed minimal changes in patient Hb and WBC counts with both machines. Similar results were reported previously.11 None of our patients experienced severe AEs. Two minor self-limiting hypotensive episodes occurred with the Optia device. Conclusion The Optia device may help reduce significant platelet losses in hematological and neurological patients undergoing TPE. It shows superior performance, compared with the COBE device. Acknowledgments I thank the nursing staff of the Apheresis Unit at the Blood Bank of Cairo University Hospital for their technical assistance. Abbreviations Abbreviations Abbreviations TPE therapeutic plasma exchange TTP thrombotic thrombocytopenic purpura ASFA American Society for Apheresis AEs adverse events Hb hemoglobin TBV total blood volume WBCs white blood cells ADAMTS13 a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 FFP fresh frozen plasma RBC red blood cell AIM automated interface management system AC anticoagulant ACD-A anticoagulant citrate dextrose, formula A Hct hematocrit CDC complete blood count ACD anticoagulant citrate dextrose NA nonapplicable CI confidence interval. References 1. Schwartz J , Padmanabhan A , Aqui N et al. Guidelines on the use of therapeutic apheresis in clinical practice-evidence-based approach from the writing committee of the American Society for Apheresis: the seventh special issue . J Clin Apher . 2016 ; 31 ( 3 ): 149 – 162 . Google Scholar PubMed 2. Wood L , Jacobs P . The effect of serial therapeutic plasmapheresis on platelet count, coagulation factors, plasma immunoglobulin, and complement levels . J Clin Apher . 1986 ; 3 ( 2 ): 124 – 128 . Google Scholar CrossRef Search ADS PubMed 3. Sultan Y , Bussel A , Maisonneuve P , Poupeney M , Sitty X , Gajdos P . Potential danger of thrombosis after plasma exchange in the treatment of patients with immune disease . Transfusion . 1979 ; 19 ( 5 ): 588 – 593 . Google Scholar CrossRef Search ADS PubMed 4. Flaum MA , Cuneo RA , Appelbaum FR , Deisseroth AB , Engel WK , Gralnick HR . The hemostatic imbalance of plasma-exchange transfusion . Blood . 1979 ; 54 ( 3 ): 694 – 702 . Google Scholar PubMed 5. Perdue JJ , Chandler LK , Vesely SK et al. Unintentional platelet removal by plasmapheresis . J Clin Apher . 2001 ; 16 ( 2 ): 55 – 60 . Google Scholar CrossRef Search ADS PubMed 6. Douglas KW , McGarvey M , Robertson S , Taylor S , Sinclair JE . An initial single-center experience with plasma exchange on the Spectra Optia cell separator machine: 106 consecutive Optia procedures compared to 114 consecutive COBE Spectra procedures on the same patient group [abstract] . J Clin Apher . 2008 ; 23 : 17 – 18 . 7. Lefevre PA , Poullin P . Therapeutic plasma exchange with the new continuous blood flow separator Spectra Optia® (abstract) . J Clin Apher . 2008 ; 23 : 43 . 8. Hequet O , Stocco V , Assari S et al. Comparison of plasma exchange performances between Spectra Optia and COBE Spectra apheresis systems in repeated procedures considering variability and using specific statistical models . Transfus Apher Sci . 2014 ; 51 ( 1 ): 47 – 53 . Google Scholar CrossRef Search ADS PubMed 9. Kim DK , Kim S , Jeong SH , Kim HO , Kim HJ . Therapeutic plasma exchange using the Spectra Optia cell separator compared with the COBE Spectra . Ann Lab Med . 2015 ; 35 ( 5 ): 506 – 509 . Google Scholar CrossRef Search ADS PubMed 10. Roxby D , Foale A , Sumsion D , McDonald L , McArdle S . Preliminary experience using the Spectra Optia apheresis system for therapeutic plasma exchange procedures (abstract) . J Clin Apher . 2008 ; 23 : 18 – 19 . 11. Tormey CA , Peddinghaus ME , Erickson M et al. Improved plasma removal efficiency for therapeutic plasma exchange using a new apheresis platform . Transfusion . 2010 ; 50 ( 2 ): 471 – 477 . Google Scholar CrossRef Search ADS PubMed 12. Cid J , Molina JM , Mustieles MJ , Periáñez M , Lozano M . Comparison of plasma exchange procedures using three apheresis systems . Transfusion . 2015 ; 55 ( 5 ): 1001 – 1007 . Google Scholar CrossRef Search ADS PubMed 13. Urdahl SG . COBE Spectra Apheresis System: designs, protocols and results . Infusionstherapie . 1989 ; 16 ( Suppl 2 ): 30 – 43 . Google Scholar PubMed 14. Winters JL , Burgstaler EA , Gottschall JL et al. A multicenter evaluation of a new therapeutic plasma exchange procedure . Transfusion . 2013 ; 53 ( 12 ): 3269 – 3278 . Google Scholar CrossRef Search ADS PubMed 15. Lambert C , Gericke M , Smith R , Hermans C . Plasma extraction rate and collection efficiency during therapeutic plasma exchange with Spectra Optia in comparison with Haemonetics MCS+ . J Clin Apher . 2011 ; 26 ( 1 ): 17 – 22 . Google Scholar CrossRef Search ADS PubMed 16. Burgstaler EA , Pineda AA . Therapeutic plasma exchange: a paired comparison of Fresenius AS104 vs. COBE Spectra . J Clin Apher . 2001 ; 16 ( 2 ): 61 – 66 . Google Scholar CrossRef Search ADS PubMed 17. Hester J . RE: Therapeutic plasma exchange: a paired comparison of Fresenius AS104 vs. COBE Spectra . J Clin Apher . 2002 ; 17 : 49 . Google Scholar CrossRef Search ADS PubMed © American Society for Clinical Pathology 2018. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices)

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Laboratory MedicineOxford University Press

Published: May 26, 2018

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