Comparison of hematopoietic progenitor cell collection using different inlet flow rates with the Fenwal Amicus.

PURPOSE: We have used a hematopoietic progenitor cell (HPC) algorithm (standard [STD]) that restricted the inlet flow rate to 65 mL/min for peripheral white blood cell count (PWBC) >35 × 109 /L (STD). In this study, we evaluated a technique that allows 85 mL/min, regardless of the PWBC count (high). For patients with PWBC >35 × 109 /L, a prospective, randomized comparison of the high flow rate vs the STD PWBC-based flow rate (65 mL/min) was performed, comparing CD34+ and lymphocyte yields, collection efficiencies (CE1), mononuclear cells (MNC), and granulocytes, red blood cell (RBC), and platelet content. METHODS: The Fenwal Amicus version 4.5 with a heparinized ACD-A anticoagulant (AC) delivered at a 26:1 AC ratio was used. Paired comparisons between high and STD techniques were assessed with Wilcoxon signed rank tests, with P < .05 considered significant. Data are summarized as medians. RESULTS: Forty patient pairs (autologous) were compared. Diagnoses included primarily multiple myeloma (60%) and lymphoma (37.5%). High had significantly higher median average inlet rates (69 vs 55 mL/min), whole blood processed (20 vs 16 L), and cycles (15 vs 14) than STD. There were no significant differences in pre-procedure counts. Collection contents were (high/STD): 306/328 × 106 CD34+ cells, 48/59% CD34+ CE1 (significant), 0.2/0.2 × 109 /kg lymphocytes, 45/57% lymphocyte CE1, 63/59 × 109 WBC, 15/16 × 109 granulocytes, and 1.9/1.7 × 1011 platelets. CONCLUSIONS: The simpler, standardized high flow technique did not significantly increase or decrease CD34+ cells or lymphocyte yields, but did significantly decrease CD34+ CE1. The effects on cross-cellular content were minimal and not clinically significant.

Infused Autograft Absolute Lymphocyte Count Predicts Superior Survival in Diffuse Large B Cell Lymphoma Patients Post-Autologous Peripheral Blood Hematopoietic Stem Cell Transplantation: A Matched Case-Control Study.

Our group published a double phase III trial showing that patients infused with an autograft absolute lymphocyte count (A-ALC) ≥0.5 × 109 cells/kg experienced superior survival post-autologous peripheral blood hematopoietic stem cell transplantation (APBHSCT). Based on the results from our phase III study, as well as published retrospective studies, on April 1, 2017, our Bone Marrow Transplant Program changed our standard practice to collect an A-ALC ≥0.5 × 109 cells/kg in addition to stem cells for lymphoma patients undergoing APBHSCT. The primary objective of the present study was to continue to assess the prognostic ability of A-ALC by evaluating overall survival (OS) and progression-free survival (PFS) of diffuse large B cell lymphoma (DLBCL) patients who underwent APBHSCT after April 1, 2017, compared with matched control groups at a 1:1:1 ratio with DLBCL patients infused with an A-ALC <0.5 × 109 cells/kg and A-ALC ≥0.5 × 109 cells/kg before April 1, 2017. Using the GREEDY algorithm, 85 DLBCL patients (cases) infused with an A-ALC ≥0.5 × 109 cells/kg after April 1, 2017, were matched at a 1:1:1 ratio with control groups of DLBCL patients who underwent transplantation before April 1, 2017: patients infused with an A-ALC <0.5 × 109 cells/kg (control 1) and patients infused with an A-ALC ≥0.5 × 109 cells/kg (control 2) before April 1, 2017. Groups were matched in terms of sex, age, stage, lactate dehydrogenase (LDH) level, performance status, extranodal disease, International Prognostic Index (IPI), and disease status before APBHSCT (complete or partial response). Survival follow-up was truncated at 3 years from the date of transplantation. Cases, control 1, and control 2 were balanced as to age (P = .8), sex (P = .9), LDH (P = .6), performance status (P = .5), extranodal disease (P = .2), IPI (P = .6), and disease status before APBHSCT (P = .2). Cases and control 2 showed superior OS and PFS compared with control 1. Multivariate analysis including all patients continued to show A-ALC ≥0.5 × 109 cells/kg as an independent predictor for OS (hazard ratio [HR], 0.382; 95% confidence interval [CI], 0.241 to 0.605; P < .0001) and PFS (HR, 0.437; 95% CI, 0.279 to 0.629; P < .0001). Our matched case-control study supports the results of previously published retrospective studies and our phase III study showing that the infusion of A-ALC is a prognostic factor for survival in DLBCL patients undergoing APBHSCT. Our findings support the practice of collecting not only enough stem cells for hematologic engraftment, but also enough immune effector cells (ie, A-ALC) to improve clinical outcomes in DLBCL patients post-APBHSCT.

Paired comparison of therapeutic plasma exchange using the Fenwal Amicus versus TerumoBCT Spectra Optia.

PURPOSE: Terumo BCT Spectra Optia (O) and Fenwal Amicus (A) can perform therapeutic plasma exchange (TPE). We compared these systems in a prospective, randomized, crossover study of 81 paired procedures. Primary objective was to determine if there was a difference in platelet loss between the instruments. Secondary objectives were to determine differences in procedure time (PT), plasma removal efficiency (PRE 1), plasma removal rate (PRR), and fluid balance (FB). METHODS: Fifty-seven adults undergoing 162 procedures were included. Diagnoses included neurologic, nephrologic, and hematologic diseases. Replacement fluids included 5% normal serum albumin and/or fresh frozen plasma. The first instrument (randomized) established the inlet flow rate for the second with a maximum inlet rate of 120 ml/min. Spun HCT was used to program the procedure. One plasma volume was exchanged, for both instruments. Multivariable general estimating equations were used to assess the relationship between the outcome variables with machine after adjusting for covariates, with P values <.05 significant. RESULTS: Median total blood volume (4,775 mL-A, 4,775 mL-O) and preprocedure spun HCT (33%-A, 34%-O) were not statistically different. The plasma removed (3196 mL-A, 3120 mL-O), PLT in waste plasma (0.62 × 1011 -A, 0.33 × 1011 -O), PLT decline (8.5%-A, 6.5%-O), and PRR (48.1 mL/min-A, 49.2 mL/min-O) were not statistically different. There were statistically significant, but clinically irrelevant, differences in PLT CE1 (6.2%-A, 3.6%-O), PRE 1 (85.3%-A, 83.9%-O), FB (+2 mL-A,+15 mL-O), and PT (71 min-A, 71 min-O). CONCLUSIONS: Statistical differences were seen but none were of a magnitude to be clinically relevant, indicating comparable TPE performance.

Iatrogenic thyrotoxicosis and the role of therapeutic plasma exchange.

Thyroid storm or severe thyrotoxicosis results from extreme thyroid hormone elevation. Therapy includes medical management to prevent hormone production, release, recycling, and peripheral conversion while stabilizing adrenergic tone. Thyroid dysfunction is the usual cause but it can be due to excessive thyroid hormone ingestion. Therapeutic plasma exchange (TPE) has been used to rapidly remove protein-bound thyroid hormone. American Society for Apheresis guidelines make a weak recommendation to perform TPE in selected patients in the treatment of thyrotoxicosis based on low quality evidence. We present a case of excessive thyroid replacement hormone ingestion treated by TPE. The patient presented with the clinical picture of thyroid storm, including cardiovascular compromise and massively elevated total and free T3 (525 ng/dL, nl 80-200 ng/dL and 28 pg/mL, nl 2.0-3.5 11 pg/mL), which failed medical therapy. A single, one plasma volume TPE was performed. Both total and free T3 demonstrated substantial declines immediately after TPE with the patient's mental status returning to near-normal. Thyroid hormone extraction efficiency and collection efficacy were calculated as 37.1% and 40.8%, respectively. Prior to discharge on day 6, the patient's compounding pharmacy indicated that a "bad batch" of bovine thyroid gland derived replacement hormone had been produced. TPE appears to be effective in removing protein bound thyroid hormone in extreme iatrogenic thyrotoxicosis.

Comparison of two double red cell collection settings on Fenwal Alyx apheresis instrument.

The Fenwal Alyx for collecting double red cell products has two red cell volume collection settings: fixed collection target of 360 ml (180 ml/unit) and a variable target of collecting either 400 or 360 ml (200 or 180 ml/unit), where the machine aims for the higher possible collection target. We retrospectively compared the two collection targets for the RBC content, donor time, technician time, and collection efficiency. We compared 18 fixed (F) target collections to 40 variable (V) target collections. All collections were performed as per the manufacturer's recommendations on Alyx and donors met the manufacturer's eligibility criteria. There was no significant difference in average whole blood processed (F: 963 ml, V: 1,000 ml); donor time (F: 43 min, V: 45 min) or technician time (F: 64 min, V: 64 min). There was a significant difference in unit volume (F: 283 ml, V: 300 ml); grams Hb/unit (F: 53 g, V: 57 g); ml RBC/unit (F: 157 ml, V: 167 ml); and RBC recovery (F: 87.8%, V: 88.9%). The fixed target had a significantly lower frequency of products with ≥51 g Hb (80.6%) than variable target (96.3%) and ≥153 ml RBC/unit (F: 55.6%, V: 96.3%). In conclusion, the variable target efficiently allows collections of products with higher red cell volume and hemoglobin without a significant increase in collection and processing time.

Double red blood cell collection: comparison of three apheresis systems.

BACKGROUND: We compared three instruments for double red blood cell (DRBC) collection to efficiently optimize our RBC inventory. STUDY DESIGN AND METHODS: Instruments compared were the TerumoBCT Trima Accel (Trima), the Fenwal Alyx (Alyx), and the Haemonetics MCS+ 8150 (MCS+). Forty consecutive collections (80 products) per instrument were evaluated for hemoglobin (Hb) content, leukoreduction, collection time, instrument efficiency, donor acceptance, and reactions. The total number of whole blood donors who could be eligible for DRBC collection was analyzed. All collections were as per the manufacturer recommendations with target volume of 360 or 400mL. Leukoreduction was integral to the collection procedure for the Alyx and Trima, while it was a separate process for the MCS+. RESULTS: The total numbers of whole blood donors who could be eligible for DRBC collection were 10,116 for the MCS+, 9378 for the Alyx, and 8573 for the Trima. All units collected had more than 42.5 g of Hb. Mean Hb levels were as follows: Trima, 59.2 g; Alyx, 56.8 g; and MCS+, 51.5 g. Donor times for the Trima, Alyx, and MCS+ were 52, 45, and 52 minutes, respectively. Technician times for the Trima, Alyx, and MCS+ (without filtration) were 87, 73, and 64 minutes. All collected products had fewer than 5 × 10(6) white blood cells. CONCLUSIONS: All three instruments would be capable of collecting an acceptable leukoreduced DRBC product. The Alyx was most portable, with the shortest donor time and total technician time (considering filtration time) and highest collection efficiency and would collect from more donors than the Trima. We thus chose the Alyx as it best fits the specific needs of our center.

Immunologic Autograft Engineering and Survival in Non-Hodgkin Lymphoma.

Retrospective studies have reported that the collected and infused autograft absolute lymphocyte count (A-ALC) affects clinical outcomes after autologous peripheral hematopoietic stem cell transplantation (APHSCT). We hypothesized that manipulation of the apheresis machine to target a higher A-ALC dose would translate into prolonged progression-free survival (PFS) in patients with non-Hodgkin lymphoma (NHL) undergoing APHSCT. Between December 2007 and October 2010, we performed a double-blind, phase III, randomized study randomly assigning 122 patients with NHL to undergo collection with the Fenwal Amicus Apheresis system with our standard settings (mononuclear cells offset of 1.5 and RBC offset of 5.0) or at modified settings (mononuclear cells offset of 1.5 and RBC of 6.0). The primary endpoint was PFS. Neither PFS (hazard ratio [HR] of modified to standard, 1.13; 95% confidence interval [CI], .62 to 2.08; P = .70) nor overall survival (OS) (HR modified to standard, .85; 95% CI, .39 to 1.86; P = .68) were found to differ by collection method. Collection of A-ALC between both methods was similar. Both PFS (P = .0025; HR, 2.77; 95% CI, 1.39 to 5.52) and OS (P = .004; HR, 3.38; 95% CI, 1.27 to 9.01) were inferior in patients infused with an A-ALC < .5 × 10(9) lymphocytes/kg compared with patients infused with an A-ALC ≥ .5 × 10(9) lymphocytes/kg, regardless of the method of collection. We did not detect significant differences in clinical outcomes or in the A-ALC collection between the modified and the standard Fenwal Amicus settings; however, despite physician discretion on primary number of collections and range of cells infused, higher A-ALC infused dose were associated with better survival after APHSCT.

A multicenter evaluation of a new therapeutic plasma exchange procedure.

BACKGROUND: The AMICUS (Fenwal, Inc.) was cleared in the United States for platelet (PLT) and plasma collection in 1996 with subsequent clearances for the collection of other blood products. Although not previously used for therapeutic plasma exchange (TPE), new disposables, software, and hardware were developed to enable TPE on the AMICUS. STUDY DESIGN AND METHODS: A multicenter, randomized, nonblinded, crossover paired treatment protocol was performed. Thirty patients with orders for at least two TPE procedures were randomly assigned to the AMICUS or the COBE Spectra (TerumoBCT) for the first treatment. Each patient was crossed over to the other device using the same procedure settings from the first procedure. The primary objective compared efficiency of plasma removal (EPR) with secondary objectives of comparing PLT and hemoglobin (Hb) waste plasma content, coagulation factor and complement activation, fluid balance tracking accuracy, procedure length, and adverse events. RESULTS: The EPR for the AMICUS (81.9 ± 7.62%) was superior to that of the COBE Spectra (75.2 ± 6.29%; p = 0.00001). The AMICUS also demonstrated statistically higher fluid balance accuracy (99.84%) compared to that of the COBE Spectra (98.83%; p < 0.0001) and a statistically shorter procedure time (103.9 ± 30.8 vs. 110.5 ± 27.1 min, p < 0.001). No significant differences with regard to PLT and Hb content in the waste plasma, change in patient PLT count, or changes in markers of coagulation and complement cascade activation were seen. Frequency and severity of adverse reactions were similar. CONCLUSION: The AMICUS separator can effectively perform TPE. The AMICUS demonstrated superior plasma removal efficiency compared to the COBE Spectra with no evidence of significant differences in PLT removal, hemolysis, and coagulation or complement activation.

Comparison of hematopoietic progenitor cell collections using the COBE Spectra version 7 and Amicus version 3.1 for patients with AL amyloidosis.

To address concerns about infused fluid volume during HPC collections in patients with AL amyloidosis, our institution has used a 26:1 anticoagulant (AC) ratio on the COBE Spectra and on the Fenwal Amicus. In this study, in a cohort of AL amyloid patients, we compared the Amicus version 3.1 to the Spectra version 7 MNC collections with regard to infused fluid volume, CD34+ cell yield, lymphocyte yield, cross-cellular content, and adverse reactions. Both instruments used a 26:1 AC ratio but the Amicus delivered significantly less AC per procedure (Amicus 678 mL vs. Spectra 753 mL). With comparable baseline CD34+ cell counts (Amicus 33 cells/µL vs. Spectra 27 cells/µL); Amicus collected significantly more CD34+ cells (3.1 vs. 1.5 × 106/kg) and equivalent lymphocytes (18.7 vs. 14.5 × 109. Amicus collected significantly fewer WBC (51.8 vs. 72.7 × 109), granulocytes (15.1 vs. 27.5 × 109), and PLT (2.3 vs. 3.9 × 10¹¹) per procedure with equivalent RBC content (26 vs. 30 mL). CD34+ cell (5.0 vs. 4.4 × 106/kg) and lymphocyte doses (32.7 vs. 33.9 × 109) were equivalent in infused products collected on the Amicus and Spectra but the frequency of high volume products was lower for Amicus. Frequency and severity of adverse reactions during collection and infusion were similar for both. In this group of AL amyloid patients, Amicus was superior to Spectra with regard to fluid infused, CD34+ cell yield, and cross-cellular contamination with equivalent lymphocyte yield and reaction incidence.

Manual color monitoring to optimize hematopoietic progenitor cell collection on the Fenwal Amicus.

A technique was developed to improve consistency of MNC transfers from the centrifuge to the collection bag in the Fenwal Amicus. The operator assures that RBCs completely fill the cassette by the end of the transfer by adjusting the RBC offset in succeeding cycles. We compared yields and crosscellular content before and after implementation of the monitoring technique. Retrospective data from 400 consecutive HPC collection procedures (200 for each technique) were compared. In 40 monitored collections, the RBC offset was adjusted to 6-9 mL to ensure that RBCs completely filled the cassette. Collections requiring these adjustments were not associated with a specific diagnosis. Median values were compared between the 40 collections requiring offset adjustment and those performed before implementation of monitoring. Baseline peripheral CD34+ cell (17 vs. 14 cells µL(-1)), lymphocytes (2 vs. 1.3 × 10(9) /L), WBCs, HCT, and PLTs were significantly higher in the group requiring offset changes. The group requiring offset changes had significantly more CD34+ cells per collection (190.8 × 10(6) or 2.04 × 10(6) /kg vs. 84.3 × 10(6) or 0.89 × 10(6) /kg) and more lymphocytes per collection (16.9 × 10(9) vs. 11.6 × 10(9)). Crosscellular content of the group requiring offset changes was significantly higher for WBCs (41.8 vs. 33.1 × 10(9)), granulocytes (9.6 vs. 7.2 × 10(9)), RBCs (23 vs. 17 mL), and PLTs (2.1 vs. 1.2 × 10(11)). Manual monitoring is a simple, inexpensive method to optimize each HPC collection to maximize CD34+ cell and lymphocyte yields.

Use of various offset settings in the Fenwal Amicus during hematopoietic progenitor cell collection to increase lymphocyte yield and reduce cross-cellular contamination.

INTRODUCTION: Autologous HPC collection focus has been CD34+ cell yield but product content of other cells is important for patient survival, complications, and resource utilization. METHODS: Prospective, paired study examining MNC and RBC offsets (opens and closes collect valve, respectively) was performed using Fenwal Amicus. Lymphocyte, CD34+ cell yields, and cross-cellular contamination were compared using different MNC/RBC offsets and retrospective Spectra data. RESULTS: In paired comparisons, median lymphocyte yields were significantly different only between 0.0/7.0 (17.6 × 10(9)) and 1.5/5.0 (14.5 × 10(9)) offsets. CD34+ yields were not significantly different between offsets except 1.0/7.0 and 1.5/5.0 (230.3 vs. 156.7 × 10(6)). Granulocytes, RBC, and PLT were significantly greater with higher RBC offset. Comparing all offsets, 1.5/5.0 collected fewer lymphocytes, granulocytes, RBC, and PLT. 1.5/6.0 offsets collected more lymphocytes than 1.5/5.0 but fewer granulocytes and RBC than others except 1.5/5.0. For 1.5/6.0 offsets, PLT content was higher than 1.5/5.0, equivalent to the other offsets, and less than Spectra. CD34+ yields for 1.5/6.0 offsets were equivalent to others except 1.0/7.0. Manufacturer's default (2.3/6.8) collected equivalent lymphocytes and CD34+ to all offsets (except 1.0/7.0) and Spectra. Cross-cellular contamination was higher than 1.5/5.0 and 1.5/6.0 but equivalent to others with more RBC and fewer PLT than Spectra. CONCLUSION: For maximum lymphocyte yield and minimum contamination, 1.5/6.0 offsets appear optimal. For minimum lymphocyte yield and contamination, 1.5/5.0 offsets would be preferred. Manufacturer's default has CD34+ cell and lymphocyte yields similar to 1.5/6.0 with greater contamination. Amicus can achieve lymphocyte and CD34+ yields similar to Spectra but has significantly less PLT removal.

Concentration changes to counteract the effects of bacteriological sampling on PLT yields.

INTRODUCTION: Bacterial culturing of apheresis platelet (PLT) units appeared to increase the incidence of low yield products of <3.0 x 10(11) PLT (LYP) and decrease the incidence of multiple PLT products. To determine the effects of sampling and subsequent modifications in collections on PLT yield and adverse reactions, a retrospective analysis was performed. METHODS: Four time periods were examined: baseline, after sampling implementation, after concentration change (Conc. Delta) implementation, and after concentration and yield target change (Target + Conc. Delta) implementation. Collections were performed on the Gambro Trima Accel. PLT concentration settings were changed from 1,550 to 1,200 (single and double PLT products) or 1,610 to 1,500 (triple PLT products). A 3.2 x 10(11) target was eliminated and a 9.4 x 10(11) target added. RESULTS: Donors in all groups were comparable. Average incidence of LYP per week was significantly higher for Sampling (8.1%) than Baseline (2.0%) and declined significantly in the Conc. Delta (3.4%) and Target + Conc. Delta (2.0%) groups. Average PLT products/donor per week for Sampling (1.7) was significantly lower than Baseline (1.8), equivalent to Conc. Delta (1.7), and significantly lower than Target + Conc. Delta (1.9). Average weekly incidence of triple PLT products was significantly higher for Target + Conc. Delta (17%) compared with Baseline (12.4%), Sampling (10.7%), and Conc. Delta (10.8%). Donor reaction incidence was not significantly different among the groups. There was no change in recipient reactions. CONCLUSIONS: The use of a yield target change and PLT concentration reduction compensated for changes associated with bacterial culturing without increasing donor or recipient reactions.

The effect of double- and triple-apheresis platelet product donation on apheresis donor platelet and white blood cell counts.

BACKGROUND: Concerned about the effect of multiple platelet (PLT) product donation on donor health, in 2005 the FDA proposed restrictions limiting the number of PLT products donated in 12 months. This was based on limited published evidence. To provide information on the effect of PLT donation on PLT and lymphocyte (LYM) count, hematologic variables were examined in a group of multiple PLT product donors. STUDY DESIGN AND METHODS: Donors with at least two apheresis PLT donations, one of which was a double- or triple-PLT product, were examined. Donor demographics, number of blood donations, and number of apheresis PLT products donated were determined. Hematologic variables were evaluated at the first and last donation. RESULTS: A total of 471 donors (median age, 48.8 years; 55% male; median time between first and last donations, 72 weeks) were studied. The median number of PLT donations was 4 (range, 1-34) with the median number of PLT products donated being 7 (range, 2-65). The median PLT count demonstrated a significant increase (14 x 10(9)/L, p = 0.0001) while both white blood cell and LYM counts showed significant decreases (-0.2 x 10(9)/L, p = 0.0052; and -0.06 x 10(9)/L, p = 0.0001, respectively). After adjusting for sex and whole-blood donations, LYM count demonstrated a significant decline associated with both number of donations (-0.01 x 10(9)/L, p = 0.01) and number of products donated (-0.005 x 10(9)/L, p = 0.02). PLT count demonstrated a significant increase associated with number of products donated (0.42 x 10(9)/L, p = 0.03). CONCLUSION: Significant but small LYM decrease and PLT increase were seen. Limitations on the number of apheresis PLT products donated within 12 months do not seem warranted due to PLT or LYM count changes.

Treatment of chronic dilated cardiomyopathy with immunoadsorption using the staphylococcal A-agarose column: a comparison of immunoglobulin reduction using two different techniques.

Auto-antibodies to myocardial antigens have been implicated in the pathogenesis of chronic dilated cardiomyopathy (DCM). A protein A immunoadsorption affinity column system was used to remove IgG antibodies, particularly IgG3. Two techniques, the standard technique (T-1) used for removal of IgG Factor VIII inhibitors and a technique (T-2) designed to enhance IgG3 removal and address issues in venous access, minimize positive fluid balance, and adverse reactions were compared. A total of four patients were treated, two patients were treated for 5 consecutive days with each technique. T-2 resulted in larger, but not significantly so, IgG3 reduction (70% and 63%) than T-1 (53% and 59%). Both techniques lowered total IgG levels by >or=93%. Because of venous access problems, 60% of T-1 procedures reached the plasma volume target versus 100% for T-2. Positive fluid balance was significantly lower for T-2 (+507 +/- 465) ml versus T-1 (+2,206 +/- 724) ml. Overall adverse event (AE) rate (T-1:16, T-2:15) was similar between the techniques but demonstrated a statistically significant difference in the types of reactions that occurred. All AE were mild in nature, common to other apheresis procedures, and were easily managed. This small study, demonstrated that a modified technique (T-2) with superior fluid balance should be used when treating DCM with the Immunosorba system.

A pilot study to assess the use of protein a immunoadsorption for chronic dilated cardiomyopathy.

Dilated cardiomyopathy (DCM) is a leading cause of end-stage heart failure and cardiac transplantation. Anticardiac antibodies are common and removal of these through immunoadsorption (IA) is associated with improvement in global cardiac function. The effect of IA on regional function and quality of life (QOL) without intravenous immunoglobulin (IVIG) substitution has not been described. We performed a pilot trial using Immunosorba columns in four patients with chronic DCM and NYHA Class II-III congestive heart failure. Subjects were followed for 6 months with serial echocardiograms and validated QOL assessments. Regional and global left ventricular (LV) end-systolic deformations were assessed by two-dimensional strain echocardiography. Total IgG decreased 95% (from 1,210 +/- 274 mg/dl to 57 +/- 16 mg/dl, P = 0.003) and IgG3 decreased 61% (from 33 +/- 16 mg/dl to 13 +/- 7 mg/dl, P = 0.024). QOL improved from baseline to 6 months as assessed by the Living with Heart Failure questionnaire (from 54 +/- 18 to 19 +/- 7, P = 0.029). Mean LV ejection fraction improved from 35 to 40% at Day 5 and to 44% at 6 months (P = NS). The LV end diastolic and end systolic volumes decreased (220-202 ml, 159-130 ml, P = NS) at 6 months. Global end-systolic strain improved from -7.3% at baseline to -8.5% at Day 5 and -8.8% at 6 months (P = NS). Regional LV function and response to IA was not uniform. Even without IVIG substitution, IA for the treatment of chronic DCM is associated with improved QOL up to 6 months after treatment. A randomized, sham-controlled trial is required to confirm the benefits of IA for DCM.

Blood component collection by apheresis.

Apheresis component collection is a rapidly growing area in the blood collection field. Several instruments with varying capabilities are available. This is a brief review of the equipment available for granulocyte and apheresis component collection and indications for their use. In the United States, granulocytes are collected with the Fenwal CS3000, Fenwal CS3000 Plus, COBE (Gambro) Spectra, Haemonetics LN9000, and Fresenius AS 104. The use of hetastarch for sedimenting agent and stimulation with G-CSF and G-CSF plus dexamethasone have substantially increased granulocyte yields. Plateletapheresis is performed in the United States on the Fenwal CS3000, Fenwal CS3000 Plus, Fenwal Amicus, COBE (Gambro) Spectra, Gambro Trima Version 4, Gambro Trima Accel (Version 5), and Haemonetics LN9000. Automated red blood cell (RBC) collections are performed with the Haemonetics MCS+LN8150, Gambro Trima Version 4, Gambro Trima Accel (Version 5), Amicus, and Baxter Alyx. The RBC can be collected concurrently (with other components) in some instruments or separately in others. Plasma is collected concurrently on several instruments. Plasmapheresis for plasma only is performed on the Fenwal Autopheresis C and Haemonetics PCS2. Granulocyte yields range from 0.46 x 10(10) to 1.0 x 10(10) for unstimulated donors and 2.1 x 10(10) to 2.6 x 10(10) for donors stimulated with dexamethasone or prednisone. The use of G-CSF and G-CSF with dexamethasone has substantially increased granulocyte yields with yields of 4.1 x 10(10) to 10.8 x 10(10) reported. Platelet collection rates of 0.045-0.115 x 10(11) plt/min have been reported. Collection efficiencies of 46-85.7% have been reported. Automated (apheresis) component collection has the advantages of controlled volumes or doses of component, efficient use of the donor, multiple components from the same donor, better inventory control, and better quality control due to less manipulation of the individual components. Disadvantages of automated component collection include the use of expensive equipment and disposables, the need for specially trained machine operators, and lower capacity to collect large volumes of blood compared to whole blood donation. The use of apheresis component collection is rapidly growing to provide the best blood components in the most efficient manner.

Paired comparison of Gambro Trima Accel versus Baxter Amicus single-needle plateletpheresis.

BACKGROUND: Gambro BCT recently introduced the Trima Accel Version 5 (TR) plateletpheresis machine. Platelet (PLT) yields, collection efficiencies (CEs), numbers of white blood cells (WBCs), and processing times of the TR versus the Amicus (Version 2.51) single-needle (AM) procedures were evaluated by use of a prospective paired comparison. STUDY DESIGN AND METHODS: Target yields of 3.0 x 10(11) to 6.8 x 10(11) PLTs in up to 100 minutes of processing time were used. To detect a difference of 1.0 x 10(11) PLTs with a power of 80 percent, 26 paired comparisons were needed. RESULTS: The mean amount of whole blood processed was significantly higher for TR than for AM (3795 vs. 3520 mL). The TR and AM were equivalent in regard to mean preprocedure PLT count (259 x 10(9) vs. 251 x 10(9)/L), PLT yields (6.7 x 10(11) vs. 6.5 x 10(11)), split rate (65% vs. 65%), processing time (73 vs. 78 min), and collection rate (0.090 x 10(11) vs. 0.084 x 10(11) PLTs/min). The TR had a significantly lower CE than the AM (76% vs. 86%). All of the products (after splitting) had fewer than 5 x 10(6) WBCs. CONCLUSIONS: The Trima Accel machine processed significantly more whole blood with equivalent PLT yields, processing time, and number of PLTs per minute compared to the Amicus single-needle procedure, but had a significantly lower CE.