Combined Platelet and Erythrocyte Salvage: Evaluation of a New Filtration-based Autotransfusion Device.

BACKGROUND: The SAME device (i-SEP, France) is an innovative filtration-based autotransfusion device able to salvage and wash both red blood cells and platelets. This study evaluated the device performances using human whole blood with the hypothesis that the device will be able to salvage platelets while achieving a erythrocyte yield of 80% and removal ratios of 90% for heparin and 80% for major plasma proteins without inducing signification activation of salvaged cells. METHODS: Thirty healthy human whole blood units (median volume, 478 ml) were diluted, heparinized, and processed by the device in two consecutive treatment cycles. Samples from the collection reservoir and the concentrated blood were analyzed. Complete blood count was performed to measure blood cell recovery rates. Flow cytometry evaluated the activation state and function of platelets and leukocytes. Heparin and plasma proteins were measured to assess washing performance. RESULTS: The global erythrocyte yield was 88.1% (84.1 to 91.1%; median [25th to 75th]) with posttreatment hematocrits of 48.9% (44.8 to 51.4%) and 51.4% (48.4 to 53.2%) for the first and second cycles, respectively. Ektacytometry did not show evidence of erythrocyte alteration. Platelet recovery was 36.8% (26.3 to 43.4%), with posttreatment counts of 88 × 109/l (73 to 101 × 109/l) and 115 × 109/l (95 to 135 × 109/l) for the first and second cycles, respectively. Recovered platelets showed a low basal P-selectin expression at 10.8% (8.1 to 15.2%) and a strong response to thrombin-activating peptide. Leukocyte yield was 93.0% (90.1 to 95.7%) with no activation or cell death. Global removal ratios were 98.3% (97.8 to 98.9%), 98.2% (96.9 to 98.8%), and 88.3% (86.6 to 90.7%) for heparin, albumin, and fibrinogen, respectively. The processing times were 4.4 min (4.2 to 4.6 min) and 4.4 min (4.2 to 4.7 min) for the first and second cycles, respectively. CONCLUSIONS: This study demonstrated the performance of the SAME device. Platelets and red blood cells were salvaged without significant impact on cell integrity and function. In the meantime, leukocytes were not activated, and the washing quality of the device prevented reinfusion of high concentrations of heparin and plasma proteins.

Spectra Optia® for Automated Red Blood Cell Exchange in Patients with Sickle Cell Disease: A NICE Medical Technology Guidance.

The Spectra Optia® automated apheresis system, indicated for red blood cell exchange in people with sickle cell disease, underwent evaluation by the National Institute for Health and Care Excellence, which uses its Medical Technologies Advisory Committee to make recommendations. The company (Terumo Medical Corporation) produced a submission making a case for adoption of its technology, which was critiqued by the Newcastle and York external assessment centre. Thirty retrospective observational studies were identified in their clinical submission. The external assessment centre considered these were of low methodological and reporting quality. Most were single-armed studies, with only six studies providing comparative data. The available data showed that, compared with manual red blood cell exchange, Spectra Optia reduces the frequency of exchange procedures as well as their duration, but increases the requirement for donor blood. However, other clinical and patient benefits were equivocal because of an absence of robust clinical evidence. The company provided a de novo model to support the economic proposition of the technology, and reported that in most scenarios Spectra Optia was cost saving, primarily through reduced requirement of chelation therapy to manage iron overload. The external assessment centre considered that although the cost-saving potential of Spectra Optia was plausible, the model and its clinical inputs were not sufficiently robust to demonstrate this. However, taking the evidence together with expert and patient advice, the Medical Technologies Advisory Committee considered Spectra Optia was likely to save costs, provide important patient benefits, and reduce inequality, and gave the technology a positive recommendation in Medical Technology Guidance 28.

Effects of the Sangvia blood collection system on patients undergoing elective hip surgery.

We have conducted a randomized controlled study where 164 patients were randomized to receive autologous salvaged blood collected by Sangvia™ Blood Salvage System or allogeneic red cell concentrates if transfusion was indicated by clinical judgement. The study was powered to detect if transfusion of autologous blood reduced the occurrence of postoperative infections. We found no statistical significant difference in postoperative infection rate between the groups, but this may be due to the fact that postoperative infections were diagnosed in only five patients. Increased C-reactive protein concentrations slightly above level of significance indicate that autologous blood transfusions stimulate the patient's immune system. However, there was no indication of increased transfusion reaction rate, including febrile reactions, in the autologous group. Transfusion of autologous blood did not reduce the use of allogeneic red cell concentrates. The mean use of allogeneic red cell concentrates was 0.93 units (both groups combined), indicating that the transfusion policy may have been too liberal. There was a highly significant inverse correlation between pre-operative haemoglobin concentration and transfusion of allogeneic blood. In a patient population with a low frequency of postoperative infection, a larger study is needed to clarify if autologous salvaged blood protects against postoperative infections.

Washing of banked blood by three different blood salvage devices.

BACKGROUND: Storage lesions in red blood cells (RBCs) lead to an accumulation of soluble contaminants that can compromise the patient. Organ failures, coagulopathies, and cardiovascular events including lethal cardiac arrest have been reported, especially with massive transfusion or in pediatric patients. Washing improves the quality of stored RBCs, and autotransfusion devices have been proposed for intraoperative processing, but these devices were designed for diluted wound blood, and limited data on their performance with RBCs are available. STUDY DESIGN AND METHODS: Three autotransfusion devices (Electa, Sorin; CATS, Fresenius; OrthoPAT, Haemonetics) differing in function of their centrifugation chambers were evaluated with RBCs at the end of their shelf life and with dilutions thereof. Elimination rates of potassium, plasma free hemoglobin, total protein, citrate, acid equivalents, and iomeprol added as a marker substance were analyzed, in addition to RBC recoveries. RESULTS: Product hematocrit (Hct) levels ranged between 54.8 and 72.6%. RBC recovery rates were between 62.7 and 95.0%, the lowest being with the OrthoPAT processing of undiluted RBCs. Plasma elimination rates increased with predilution and ranged from 46.6% to 99.5%, the lowest being with the CATS and undiluted RBCs. Washing did not change pH and buffering capacity of RBCs. CONCLUSION: Autotransfusion devices offer a practical and obviously economical option to wash banked RBCs intraoperatively to prevent hyperkalemia and other disturbances in massive transfusion or pediatric patients. Predilution improves elimination rates, especially in devices that produce high product Hct levels. With a Y-tubing the RBCs should bypass reservoir and vacuum, and the procedure should be guarded by a policy and procedure manual and a quality management system.

[Analysis of modern blood reinfusion apparatuses].

The paper gives a brief review of the engineering solutions now applied to the clinical use of a blood reinfusion procedure. It considers simple, transient, and sophisticated (automatic) blood reinfusion methods, their advantages and disadvantages, and the areas of their possible clinical application.

The Haemonetics Cell Saver 5 washing properties: effect of different washing pump and centrifuge speeds.

This study evaluated the effect of different washing and centrifuge rates of the Cell Saver 5 on the quality of processed autologous blood. Autologous blood was washed with 1000 ml of sterile normal saline at centrifuge speed of 5650 revolutions per minute (rpm) (group I) or 4350 rpm (group II) with different washing pump speeds--500, 800 and 1000 ml/min. Hemoglobin, free hemoglobin, hematocrit, erythrocytes, leukocytes, platelets, and protein were measured before and after processing. The highest values of hemoglobin, hematocrit and erythrocytes were achieved using 800 and 1000 ml/min pump speeds in group I and 500 ml/min speed in group II. Red blood cells concentration was higher in group I. There were no significant changes of free hemoglobin removal within group I. In group II the lowest free hemoglobin was achieved when 1000 ml/min rate was used. Platelets and protein did not depend on wash pump speeds in both groups. Platelet recovery in group I was higher than in group II at all washing pump speeds. Leukocytes were not adequately removed at all pump speeds. The Cell Saver 5 produces optimum results when the high wash pump speeds (800 and 1000 ml/min) and standard centrifuge speed are used.

Processing of stored packed red blood cells using autotransfusion devices decreases potassium and microaggregates: a prospective, randomized, single-blinded in vitro study.

The aim of the study was to compare the potential of autotransfusion devices to reduce non-infectious complications related to transfusion of long-stored packed red blood cells (PRBC; n= 57), such as changes in electrolytes, blood cells and the load of free microaggregates. Following a baseline measurement, a blood pool of three PRBC was divided into three equal volumes and washed with either the Haemonetics Cell Saver (HCS) or the continuous autotransfusion system (C.A.T.S), using the quality (CATS(quality)) and emergency (CATS(emergency)) mode. After the washing procedure, measurements for electrolytes, blood cells and free microaggregates were repeated (n= 19 each). Compared with baseline, the investigated autotransfusion devices reduced the median load of potassium (baseline: 52 mEq L(-1); HCS: 4 mEq L(-1); CATS(quality): 4 mEq L(-1); CATS(emergency): 17 mEq L(-1); each P < 0.001), restored a physiologic electrolyte balance and significantly decreased the load of leucocytes, glucose and protein. Whereas the quantity of microaggregates was not reduced by HCS, CATS(emergency) decreased the load of cell fragments below 7.8 microm (P < 0.05 vs. baseline). Using CATS(quality) decreased the load of cell fragments not only to a diameter below 7.8 microm (P < 0.001 vs. baseline) but also of microaggregates between 7.8 and 17.6 microm (P < 0.05 vs. baseline). In situations where long-stored PRBC have to be transfused, the procedure described here may be feasible to reduce clinically relevant side effects, i.e. hyperkalaemia and microvascular obstruction secondary to free cell fragments. This approach could be especially useful in patients undergoing massive transfusion and/or suffering from renal failure.

[Efficacy of intraoperative apparatus autotransfusion of the blood in revisional endoprosthesis of the hip joint].

Significant blood loss and the methods of its compensation constitute one of the main problems of revisional prosthesis of big joints. Application of a patient's blood constitutes the most available and secure way of the problem solution at the modern stage of surgery evolution. The apparatus autotransfusion of the blood owes prominent place in the system of the blood saving, solely as well as in combination with autodonoring and preoperative hemodilution. In the patients, to whom the revisional prosthesis of the hip joint was performed, using intraoperative apparatus autotransfusion of the blood and the donor's erythrocytes, the red blood indexes were investigated on the stages of operative intervention and postoperative period. Application of apparatuses, such as Cell Saver, constitutes optimal and secure method of the blood oxygentransporting function restoration in the revisional prosthesis of big joints operations.

Quality of red blood cells using the Dideco Electa autotransfusion device.

The purpose of this study was to evaluate the quality of washed, concentrated red blood cells (RBCs) produced by the new Electa autotransfusion device from Cobe Cardiovascular (Dideco). Blood was collected intraoperatively in 16 patients undergoing cardiac surgery for whom routine cell savage was being used and then washed using the Electa. According to the manufacture's protocol. 125-mL bowls were used in the standard wash program. Reservoir and washed RBCs were analyzed for platelets (PLTs), leukocytes (WBCs), potassium (K+), and plasma-free hemoglobin (PFH) removal, as well as, hematocrit (Hct) and RBC recovery. The Electa cell saver produced a product with an average Hct of 58+/-5% and a RBC recovery rate of 87+/-10%. Its removal of waste products resulted in the washout of 54+/-18% WBCs, 87+/-6% PLTs, 91+/-4% K+, and 77+/-17% PFH. The Electa produces a good-quality washed RBC product that is comparable with other autotransfusion devices on the market.

Economic analysis of an intraoperative cell salvage service.

UNLABELLED: In the United States, the cost of erythrocyte transfusion exceeds 1.3 billion dollars annually. The fear of viral disease transmission popularized intraoperative salvage to reduce the use of banked blood. Although the economics of this technique have been questioned, the financial variables in providing an intraoperative autotransfusion service have not been analyzed. We designed mathematical models to determine the most cost-effective strategy based on hospital caseload. Four models were analyzed with a spreadsheet to project costs of an intraoperative autotransfusion service when fully or partially outsourced, performed by a full-time technician employee, or performed by a cross-trained employee. The Partially Outsourced model was more economical than the Fully Outsourced model when the annual caseload exceeded 185 cases. The New Employee model became more economical than the Fully Outsourced model when the annual caseload exceeded 110 cases. The Cross-Trained model was the most economical when annual caseload exceeded 55 cases. IMPLICATIONS: Cross-training an employee as a cell salvage technician is more economical than outsourcing when caseload exceeds 55 per year.

[Autotransfusion after cardiac surgery. Hematological, biochemical and immunological properties of shed mediastinal blood]. / Autotransfusión postoperatoria en cirugía cardíaca. Características hematológicas, bioquímicas e inmunológicas de la sangre recuperada del drenaje mediastínico.

OBJECTIVE: Although it is well documented that the reinfusion of unwashed shed blood reduces postoperative homologous blood requirements after cardiac surgery, the efficacy and safety of the technique has been questioned on the basis of several possible adverse effects. We therefore aimed to evaluate the extent of mediastinal shed blood damage by cardiopulmonary bypass (CPB) and extravasation. PATIENTS AND METHOD: Five perioperative blood samples were obtained from each of the 20 patients undergoing cardiac surgery: by venipuncture, during the induction of anesthesia (sample 1), at the end of CPB (sample 2), and one hour after mediastinal shed blood reinfusion (sample 5), and from the cardiotomy reservoir at the first and sixth postoperative hours (samples 3 and 4). Hematological, biochemical and immunological parameters, and the metabolic and functional status of shed erythrocytes were studied in each sample. RESULTS: Hematological and biochemical values were lower at the end of CPB and in shed blood, but not after reinfusion. Inversely, plasma free hemoglobin levels and echinocyte formation were elevated after CPB and in shed blood, the latter correlating with the decrease in serum albumin levels due to hemodilution. No alterations were detected in erythrocyte median corpuscular fragility, D-glucose, L-phenylalanine and L-serine uptakes or 2,3-bisphosphoglycerate content. Plasma IL-10 levels were elevated at the end of CPB, whereas shed blood showed increased levels of IL-1beta, IL-6 and IL-10. Shed blood retrieval did not modify the pattern of circulating cytokines found at the end of CPB. CONCLUSIONS: Shed mediastinal blood salvaged after cardiac surgery seems to be an excellent source of red cells, which conserve functional and metabolic status; once reinfused, shed blood does not modify the inflammatory response of the patient to CPB.

Quality of processed blood for autotransfusion.

Centrifugal red blood cell washers for intraoperative autotransfusion process shed blood during surgery. In this study, the quality of processed fresh, human bank blood was assessed in a standardized laboratory setting during standard, medium, and high flow processing. Red cell recovery rates and plasma washout efficiencies were compared using three different devices. The accurate parameters measuring effectiveness and product quality were red cell mass (RCM) flow rate and the plasma washout efficiency. Cobe BRAT 2, a system with discontinuous flow (DF) and a cylindrical centrifuge bowl, permitted processing in standard and medium flow of 26 and 35 mL RCM/min, respectively, with washout of residual plasma albumin of 93.2 and 91.2%. The Medtronic Sequestra 1000, a DF system with a conical centrifuge bowl processed blood at 15 and 23 mL RCM/min and eliminated plasma albumin with 98.4 and 96.8% washout during standard and medium flow, respectively, with significant red cell loss occurring during medium flow. The respective speeds of high-flow programs with BRAT 2 and Sequestra 1000 were 15 and 22 mL RCM/min, related to a hematocrit in the holding bag, less than that of the incoming blood from the reservoir. Washout was 58.2 and 58.3%, respectively. Fresenius CATS, a continuous flow (CF) device, produced flow rates of 19, 24, and 43 mL RCM/min and plasma albumin elimination of 97.8, 94.4, and 93.3% in standard, medium, and high-flow, respectively. Holding bag hematocrits with CF exceeded that of DF. Standard, medium, and high-flow programs of CATS may be used without restriction.

A simulation study for the design of a control system for the blood concentration process in autotransfusion.

Autotransfusion is the process in which a patient serves as his or her own blood donor; its most important application is the intraoperative blood salvage, in which the blood collected during a surgical operation is filtered, concentrated, washed, and then reinfused. In an automatic autotransfusion device, such as the DIDECO Compact Advanced, red blood cells (RBCs) are separated from the other unwanted components and concentrated by using a rotating bowl and the effect of centrifugal force. An important characteristic of concentrated RBCs is their hematocrit (Hct), i.e., percent RBC volume divided by total blood volume. The aim of this study is to assess the feasibility of a controller, based on the artificial neural network approach, which is able to provide a closed loop control of the hematocrit of the blood in the bowl at the end of the concentration phase. A simulation approach was adopted both for training the network and for assessing its performances. The results obtained are quite satisfactory, since the target Hct was typically reached within a 3% error, and always within 6% in highly challenging situations.

[Practical aspects of mechanical autotransfusion in tumor surgery in a decentralized clinic]. / Praktikabilität der maschinellen Autotransfusion in der Tumorchirurgie an einem dezentralen Klinikum.

The surveys of Hansen et al. demonstrated the safe inactivation of tumor cells in salvaged blood by g-irradiation. This method opens up the possibility of extending the intraoperative autotransfusion to tumour surgery. A prospective survey at the University Hospital of Leipzig demonstrated the practicability of intraoperative autotransfusion with gamma-irradiation of salvaged blood at a hospital with a decentralized structure. A clinically-relevant reduction of quality of the blood product by gamma-irradiation with 50 Gray or by transport was not observed. Adherence to fixed working regulations ensures that gamma-irradiation is conducted correctly and the salvaged erythrocyte concentrate is available in an acceptable period of time.

Methods for warming intravenous fluid in small volumes.

PURPOSE: Laboratory experiments were performed to determine warming rates of albumin 5% at room temperature and human packed red blood cells (PRBCs) at 4 degrees C in small volumes. Four methods used in clinical practice to warm volumes appropriate for neonates were studied. METHODS: The fluids were warmed either by infusion through a fluid warmer with temperature-controlled coaxial tubing (Group I), immersion in a water bath at 37 degrees C (Group II), placing pre-filled syringes (10 and 20 ml) between a circulating water mattress and a forced-air warming blanket (Group III), or placing the same syringes between the water mattress and cotton towels (Group IV). The temperature of each fluid was recorded for the next 60 sec after the bolus injection in group I and every five minutes for a total of 30 min for the other groups. The time constant of warming for each group was calculated. The time constant and the temperature reached after the warming period were compared among groups. RESULTS: In group I 20 ml room temperature albumin 5% or 4 degrees C blood reached temperatures of 36.9 +/- 1.5 degrees C and 34.5 +/- 2.3 degrees C within 60 sec, respectively. This was faster than all other techniques used (P < 0.001). The time constants measured for the albumin and the PRBCs were 0.23 +/- 0.1 and 0.20 +/- 0.05 minutes respectively. After 15 min albumin and PRBCs in group II reached 35.5 +/- 0.4 degrees C and 33.4 +/- 0.3 degrees C, in group III reached 33.7 +/- 1.0 C and 32.8 +/- 1.7 C, and in group IV reached 29.5 +/- 0.1 degrees C and 23.3 +/- 0.8 degrees C after 15 min respectively. CONCLUSION: Warming of intravenous fluids in small volumes is accomplished most rapidly using a fluid warmer with temperature-controlled coaxial tubing and occurs more slowly in syringes, bottles, or bags exposed to various environmental conditions.

[The role of the Cell Saver autologous transfusion method in preventing the pulmonary distress syndrome during open-heart operations on children]. / Rol' autotransfuzionnoi metodiki "Cell Saver" v profilaktike legochnogo distress-sindroma pri operatsiiakh na otkrytom serdtse u detei.

Complex estimation of the state of the lungs at the postperfusion and early postoperative periods based on roentgenological, clinical data, investigations of the parameters of oxygenation and mechanics of respiration was carried out in 32 children with septal defects of the heart, operated upon under conditions of artificial blood circulation with different kinds of the transfusion maintenance including the apparatus "Cell Saver 5" (CS) for the reinfusion of autoerythrocytes. The dynamics of endotoxicosis, hematological parameters during and after operation and requirements in transfusion media were studied. Differences in these indicators were established between the patients operated upon with the use of donor hemocomponents and those who were operated upon with CS. It allowed a conclusion about the role of the method of intraoperative reinfusion of erythrocytes in substantially less frequency and severity of the postperfusional pulmonary complications in this category of patients.

[Mechanical autotransfusion also in transurethral resection of prostatic adenoma? Studies of preserved washed erythrocyte concentrates before possible retransfusion]. / Maschinelle Autotransfusion (MAT) auch bei der transurethralen Resektion des Prostata-Adenoms (TUR-P)? Untersuchungen der aufbereiteten gewaschenen Erythrozyten-Konzentrate (AGEK) vor einer möglichen Retransfusion.

AIM: Does cell-saving during transurethral resection of prostatic adenoma (TURP) provide autologous washed erythrocyte concentrates (AWECs) of the same haematological and bacteriological quality as that of established indications of a cell-saving device? Should the cell-saving device be used routinely in TURP? METHODS: 37 patients underwent TURP with written, informed consent. All patients had antibiotic therapy prior to surgery. Shed blood was processed by a cell-saving device. AWECs specimens were analysed for red blood count, electrolytes, LDH, extracellular haemoglobin, osmotic fragility, blood culture and bacterial concentration. In addition, data of urine cultures, adenoma cultures and adenoma histology were analysed. AWEcs were not retransfused. RESULTS: Haematological quality was shown to be comparable to that of established applications of a cell-saving device. However, 82% of the AWECs were contaminated with bacteria. Concentrations were as high as > 10(6) bacteria/ml. Isolated bacteria ranged from e. coli and pseudomonas to staphylococci, streptococci and candidae. Bacteria found in the urine cultures of patients with urinary tract infections could also be isolated in their AWECs. 16% of the patients had prostatic cancer not know preoperatively. Mass of resected adenoma and volume of AWEC did not correlate. CONCLUSIONS: In despite of good haematological quality we considered the rate of 82% bacterial and 16% tumour cell contamination of the AWECs unacceptable and, contrary to some literature data, we no longer use a cell-saving device in TURP.

Recovery of intraoperatively shed blood in aortoiliac surgery: comparison of cell washing with simple filtration.

To regain blood shed intraoperatively, two different systems are clinically established: washing and centrifuging red blood cells to produce autologous erythrocyte concentrates and devices for immediate reinfusion of whole blood after mere filtration. In a prospective-randomised study to compare both methods regarding their efficiency, adverse effects, and economy, 20 patients of our department undergoing elective aortoiliac surgery received intraoperative autotransfusion by means of either cell-washing (CS) or salvage of whole blood (WB). Patients were preoperatively randomized into one of the two groups and were evaluated with respect to standard metabolic and haematological laboratory parameters preoperatively, during surgery, after transfer into the recovery room, 24 h after surgery, after transfer into the recovery room, 24 h after surgery, and at discharge. Both patient groups were well comparable in demographics, preoperative laboratory data, and indication for operation. Handling was easier, the set-up time was shorter with the whole blood filtration device (10.2 +/- 2.3 versus 21 +/- 1.9 min, p = 0.0023), and no additional personnel was needed to run the system. The whole blood device also allowed a greater percentage of aspirated blood to be returned intraoperatively compared to cell washing (73.5% +/- 7.2 versus 51.1% +/- 6.5, p = 0.03). Thrombocytopenia occurred in 7 (CS) and 3 (WB) patients intraoperatively with a significant difference in platelet count between the two groups (118 +/- 17 [CS] versus 170 +/- 12 [WB]*10(9)/L, p = 0.025). Expected changes in the perioperative course of the clotting parameters such as highly increased PTT levels and moderately prolonged prothrombin times occurred in all cases.(ABSTRACT TRUNCATED AT 250 WORDS)