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Ann Thorac Surg 2004;77:1553-1559
© 2004 The Society of Thoracic Surgeons

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Original articles: cardiovascular

Safety and efficacy of perioperative cell salvage and autotransfusion after coronary artery bypass grafting: a randomized trial

^a Department of Cardiothoracic Surgery, Derriford Hospital, Plymouth, United Kingdom

Accepted for publication October 14, 2003.

^* Address reprint requests to Dr Murphy, Department of Cardiothoracic Surgery, Bristol Heart Institute, Bristol Royal Infirmary, Bristol BS2 8HW, UK
e-mail: gavinmurphy{at}hotmail.com

Presented at the Fiftieth Annual Meeting of the Southern Thoracic Surgical Association, Bonita Springs, FL, Nov 13–15, 2003.

	Abstract

Top Abstract Introduction Patients and methods Results Comment Acknowledgments Discussion References

 
BACKGROUND: The aim of this study was to ascertain whether cell salvage and autotransfusion after first time elective coronary artery bypass grafting is associated with a significant reduction in the use of homologous blood, a clinically significant derangement of postoperative clotting profiles, or an increased risk of postoperative bleeding.

METHODS: Patients were randomized to autotransfusion (n = 98) receiving autotransfused washed blood from intraoperative cell salvage and postoperative mediastinal fluid cell salvage after coronary artery bypass surgery or control (n = 102) receiving stored homologous blood only after coronary artery bypass surgery.

RESULTS: There was no statistical difference between the groups in terms of demographics, comorbidity, risk stratification, or operative details. Mean volume of blood autotransfused was 367 ± 113 mL. Patients in the autotransfusion group were significantly less likely to receive a homologous blood transfusion compared with controls (odds ratio 0.40, 95% confidence interval [CI] 0.22–0.71) and received significantly fewer units of blood per patient compared with controls (0.43 ± 1.5 vs 0.90 ± 2.0 U, p = 0.02). There was no difference between the groups in terms of postoperative blood loss, fluid requirements, blood product requirements, or in the incidence of adverse clinical events (p = NS ²). Autotransfusion did not produce any significant derangement of thromboelastograph values or laboratory measures of clotting pathway function (prothrombin time, activated partial thromboplastin time, fibrinogen, and fibrinogen D-dimer levels) when compared with the effect of homologous blood transfusion (p = NS, repeated measures analysis of variance [MANOVA]).

CONCLUSIONS: Autotransfusion is a safe and effective method of reducing the use of homologous bank blood after routine first time coronary artery bypass grafting.

	Introduction

Top Abstract Introduction Patients and methods Results Comment Acknowledgments Discussion References

 
Reinfusion of autologous blood after cardiac surgery has been advocated to reduce the risk of transfusion reactions and to limit potential infectious risks associated with donor blood. Despite initial reports suggesting a significant benefit after autotransfusion of unprocessed, salvaged, intraoperative blood and shed mediastinal fluid [1–3] it became apparent that the autotransfusion of unwashed fluid was associated with fibrinolysis, coagulopathy, excessive bleeding, and a paradoxical increase in the utilization of homologous blood [3–6]. More recent randomized trials of both intraoperative [7] and postoperative cell salvage [8] with autotransfusion of washed cells have shown significant reductions in homologous blood use without increased blood loss. In spite of these findings, however, mechanical blood conservation remains underutilized in perioperative blood conservation [9, 10] in part because the issue of coagulopathy after autotransfusion has not been adequately addressed. The aim of this study was to compare the effects of autotransfusion of washed salvaged red cells on coagulation pathway function and blood loss after cardiac surgery in a randomized controlled trial.

	Patients and methods

Top Abstract Introduction Patients and methods Results Comment Acknowledgments Discussion References

 
Study population
Between March 2002 and January 2003, 200 patients admitted to our institution for coronary artery bypass grafting (CABG) operations utilizing cardiopulmonary bypass (CPB) consented to enrollment in the study. Male or female patients aged 18 or over who were undergoing nonemergency first time coronary artery bypass grafting were eligible to take part. Exclusion criteria included those patients who are prevented from utilizing blood and blood products according to a system of beliefs (eg, Jehovah's Witnesses), patients on warfarin, heparin, or other systemic anticoagulant drugs preoperatively, patients with congenital or acquired platelet, red cell, or clotting disorders, patients with ongoing or recurrent systemic sepsis and patients who were unable to give full informed consent for the study (eg, learning or language difficulties). The study received local ethical committee approval.

Technical procedure
Patients were assigned to one of two randomized groups: one (autotransfusion group) had autotransfusion of washed intraoperative salvaged or postoperative shed mediastinal fluid as first line blood replacement therapy, postsurgery, in the intensive care unit. The other group (control group) was administered banked, homologous, leucodepleted packed red cells only as blood replacement therapy. The threshold for transfusion of homologous blood in controls was hemoglobin (Hb) less than 7 g/dL, a packed cell volume (PCV) less than 0.2, or, if clinically indicated in patients with excessive blood loss and cardiovascular instability at the discretion of intensive care (ITU) staff. Patients were randomized to the two treatment arms in a 1:1 ratio by using a block randomization procedure. Allocations were generated by a card system and concealed in sealed opaque envelopes. Patients that had given consent were randomized immediately before surgery.

In the autotransfusion group all blood loss from skin incision to commencement of CPB and then after administration of protamine to skin closure was salvaged via a single lumen suction tube flushed with heparinized 0.9% normal saline (10 u/ml infused at 83 ml/h) connected to the closed rigid collection chamber of the Autolog autotransfuser device (Medtronic, Watford, UK) at high pressure suction. During CPB all spilt blood was aspirated by the CPB machine cardiotomy suckers and returned to the venous reservoir. All blood remaining in the CPB circuit after discontinuation of bypass was retransfused via the aortic cannula before decannulation and was never transferred to the autotransfuser. After closure of the sternum 28Fr soft sump drains (1–3 in number) were then connected via a Y connector to the same heparinized suction tubing and the suction reduced to 20 cm H₂O, identical to that used for the control group. All subsequent shed mediastinal fluid for the first 12 hours postoperatively was then collected into the same collection chamber. After 12 hours hospital health and safety policy stated that all autotransfuser disposables must be discarded, at which point the drains were connected to drainage bottles identical to controls.

In the control group all blood spilt before commencement of CPB and after administration of protamine was aspirated using a high pressure sucker and discarded. Postoperative mediastinal drainage was achieved by 28F single lumen rigid sump drains to a 1000 ml sterile collection chamber connected to 20 cm H₂O wall suction via an underwater seal from which collected blood was discarded.

Before autotransfusion the heparinized salvaged intraoperative blood and shed mediastinal drainage fluid underwent a washing process with resuspension of the red cells in saline at a hematocrit of 0.6. This red cell suspension was then transferred to a sterile collecting bag that was disconnected from the autotransfuser and administered via a standard blood giving set. Salvaged washed red cells were autotransfused at any time postoperatively if clinically indicated as determined by ITU staff. Otherwise salvaged blood/fluid was processed and the red cells autotransfused automatically every 4 hours before discarding of disposables at 12 hours. The low yield of intraoperative cell salvage meant that intraoperative processing and autotransfusion was not performed. Patients requiring further blood transfusion after autotransfusion (Hb < 7 g/dL, PCV < 0.2, or where clinically indicated) received homologous bank blood. Clotting products and platelets were administered at the discretion of the cardiac intensive care unit (CITU) staff in response to bleeding in the presence of coagulopathy or diminished platelet count.

Operative procedure
All patients received standard fentanyl/propofol anesthesia. All patients received anticoagulation with 300 u/kg heparin, with supplemental doses if required, to achieve an activated clotting time (ACT) greater to 400 seconds before the commencement of CPB. Anticoagulation was reversed with protamine in a 1:1 ratio until the ACT had returned to within 10% of control values. CPB was established using a standard circuit with one of two membrane oxygenators (Jostra AG, Germany; Sorin Biomedica, Gloucester, UK) and a standard volume of prime (l L Hartmans, 800 ml Gelofusin, 100 ml 20% Mannitol, 5000 u Heparin). CPB flows were kept to approximately 2.4 L/min with moderate hypothermia (32°–34°C) and mean arterial pressures maintained between 50–80 mm Hg. The use of antifibrinolytic agents and myocardial preservation technique were at the discretion of the operating surgeon. Indications for intraoperative homologous blood transfusion were Hb less than 7 g/dl or hematocrit less than 0.21 during CPB. All patients had pedicled left internal thoracic artery grafts. No patient had predonated autologous blood for use perioperatively.

Laboratory and bedside measurements of clotting pathway and platelet function
Hb concentration and hematocrit measurements were performed preoperatively on arrival in the CITU and then at 2 hourly intervals or as clinically indicated via the indwelling arterial cannula. Hb, platelet count, prothrombin time (expressed as international normalized ratio [PT ratio], a measure of the extrinsic and common clotting pathways), activated partial thromboplastin time (APTT, expressed as APTT ratio to a normalized control value, a measure of the intrinsic and common clotting pathways), fibrinogen concentration, D-dimer concentration, and thromboelastography (TEG, Thromboelsatograph; Hemoscope, Skokie, IL) measurements were performed at the start and end of the operation and immediately before and 20 minutes after the infusion of the first autologous or homologous transfusions postoperatively. TEG was performed on celite-activated whole blood drawn from the arterial line.

Statistical analysis
Overall, blood utilization after cardiac surgery at Derriford Hospital was 63% over the period April–June 2001. In order to detect an overall difference in blood utilization of 20% with a power of 0.8 and an alpha value of 0.05, 96 patients were required for each arm of the study (total 192 patients). Analysis was by intention to treat. All data were assessed for normality of distribution and equality of variance. The Student t test and ANOVA were used to compare normally distributed data and Mann–Whitney was used to compare non-normally distributed data. Categorical data were compared using the Pearson ² test. Data distribution is presented throughout as mean ± standard deviation (SD). Multivariate logistic regression was used to determine the independent effect of autotransfusion on the risk of receiving an allogeneic blood transfusion. General linear model repeated measures analysis (MANOVA) was used for analysis of variance when the same measurement was made several times on each subject. All data analysis was performed using the SPSS (Statistical Program for the Social Sciences) for Windows, Version 9.0 (SPSS UK Ltd., Chertsey, UK) software package.

	Results

Top Abstract Introduction Patients and methods Results Comment Acknowledgments Discussion References

 
Baseline characteristics
A total of 16 patients failed to complete the study. In 4 patients (control n = 3, autotransfusion n = 1) it was decided intraoperatively to perform the grafts off pump. These patients were excluded from further analysis. In the autotransfusion group, two cases were withdrawn because of deviation from protocol and two were withdrawn intraoperatively because of an apparent post-CPB coagulopathy. The remaining patients, all in the autotransfusion group (n = 8), had the autotransfuser withdrawn because of excessive bleeding or cardiovascular instability in the immediate postoperative period. All these patients (n = 12) were transferred to the type of drainage used in the control group but were included in analysis on the basis of intention to treat. There was no difference between the groups in terms of comorbidity (Table 1), severity of coronary artery disease, left ventricular function and EUROscore (European System for Cardiac Operative Risk Evaluation) (Table 2), intraoperative factors, or the use of pharmacological blood conservation agents (Table 3). There was no difference in the effect of operation time and CPB when paired analysis (repeated measures, MANOVA) was used to compare immediately preoperative and postoperative laboratory and TEG (data not shown) measurements of clotting pathway function, Hb, and platelet count (Table 4).

View larger version (22K): [in this window] [in a new window]   Fig 1. Homologous blood usage: number of patients requiring homologous blood transfusion. There was a significant reduction in the number of patients requiring homologous banked blood in the autotransfusion group. Pearson 2 p = 0.002.

View larger version (10K): [in this window] [in a new window]   Fig 2. Homologous blood usage: number of units of blood per patient. There was a significant reduction in the mean number of units per patient in the autotransfused group compared with controls. Mann–Whitney p = 0.029.

	Comment

Top Abstract Introduction Patients and methods Results Comment Acknowledgments Discussion References

The major limitation of this study was the high withdrawal rate in the autotransfusion group. In patients with excessive postoperative bleeding or in those with postoperative cardiovascular instability it was considered unethical to proceed with a treatment that had not, at that time, been demonstrated clearly to be safe in terms of generating a coagulopathy. It is possible that had these patients been included and higher volumes of autotransfused blood been administered. There may have been a significant clinical effect or differences between the groups in terms of measures of clotting pathway function. The justification for our cautious approach is evident in the apparent lack of any increase in adverse events associated with autotransfusion. Furthermore, there was still a highly significant reduction in homologous blood usage despite the withdrawal of the autotransfuser in such a large number of patients. The second limitation of this study was the low number of patients in each group that had been administered aprotinin or antifibrinolytic agents. Modern attitudes to blood conservation stress the importance of a multimodality approach with both pharmacological and mechanical blood conservation [11]. Had the proportion of patients receiving, for example, aprotinin been greater, then the overall proportion of controls receiving allogeneic blood may have been smaller [12] and the yield of autotransfused blood may also have been lower [13]. Pharmacological agents are often considered unnecessary in nonemergency first time CABG, however, and this study will have direct reference to the practice of some surgeons who restrict the use of pharmacological agents to emergency, redo, or more complex surgery [10].

Several recent trials have demonstrated a significant reduction in exposure to allogeneic blood with the use of washed autotransfused cells from both intraoperative [7] and postoperative cell salvage [14]. These studies had higher postoperative transfusion thresholds (9–10 g/dL) that are associated with higher homologous transfusion rates [15] than in the current study. For example, a previous study [8] with a transfusion threshold of 10 g/dL, reported a reduction of homologous transfusion rates reported from 90%–60%. This compares unfavorably with the allogeneic transfusion rate in the control group of 60% with a transfusion threshold of 7 g/dL. Neither of these previous studies addressed the issue of potential coagulopathic changes in patients after cell salvage and autotransfusion. This study demonstrates that autotransfusion was associated with a more significant derangement of APTT ratio than homologous blood however this was not associated with any clinical sequelae. It is likely that these findings reflect the power of paired analysis to detect very small differences in large sample sizes. Given that all other measures (with the exception of a greater reduction in PT ratio) were not altered in any way suggests that whereas autotransfusion does alter some indices of clotting pathway function at the volumes transfused using this methodology the effect is virtually identical to that of homologous blood. Indeed homologous blood itself has anticoagulant properties and can, in large volumes, induce a coagulopathy. This data would suggest that autotransfused, washed, shed mediastinal, and intraoperative cells are as effective and as safe as bank blood in this respect. This study is also significant in that cell salvage and autotransfusion has been shown to be efficacious and safe in nonemergency bypass graft excluding patients that were systemically anticoagulated with heparin preoperatively. The benefit may therefore be more marked in more complex or emergency surgery where blood loss and the subsequent yield of cell salvage is greater [16]. Previous trials of autotransfusion of washed red cells have been criticized for the low yield in terms of retransfused red cells with a subsequent low efficacy [17, 18]. The extraction ratio in the present study was 0.5 and yielded the equivalent of approximately 1 U of homologous blood per patient. This volume was significant in that it reduced the number of patients exposed to allogeneic blood. Furthermore both autotransfused and control patients had identical mean Hb concentration at two days postoperatively highlighting the viability of the autotransfused cells [19].

In conclusion intraoperative and postoperative cell salvage is efficacious and safe after CABG. This study has shown that autotransfusion of washed cells is not associated with a derangement of clotting profiles. What changes there were, were not clinically significant and were measurably no different from those produced by the transfusion of a unit of homologous leucodepleted packed red cells. Further trials in more complex surgery with or without the addition of pharmacological agents that reduce postoperative blood loss are required to evaluate this technique as part of a more comprehensive multimodality blood conservation strategy.

	Acknowledgments

Top Abstract Introduction Patients and methods Results Comment Acknowledgments Discussion References

 
The authors are grateful to the Cardiac Intensive Care nursing staff for their hard work and assistance during this study. Medtronic provided funding for the Autotransfuser consumables used in this study but had no input as to the design, data collection, and analysis or drafting of this report.

	Discussion

Top Abstract Introduction Patients and methods Results Comment Acknowledgments Discussion References

 
DR LYNN H. HARRISON (New Orleans, LO): Do you have information regarding the lowest hematocrit on bypass on these patients? Some recent data have suggested that it is causally related to increased morbidity and mortality.

DR MURPHY: I know that the hematocrit that we transfuse on bypass is less than 0.2. I think the hemoglobin trigger is 6. I don't know from our perfusionist charts what the lowest hematocrit was in this group of patients.

DR JOHN W. HAMMON, JR: (Winston-Salem, NC): I would like to congratulate the authors for carefully studying this group of patients. I think asking this question periodically is important. My question relates to the infusion of shed mediastinal blood after the patient reaches the intensive care unit. It appeared to me that despite the fact that there was no statistical difference between your groups of patients, there were several patients in the autotransfusion group who had very long lengths of stay and severe bleeding incidents.

It was our experience in using shed mediastinal blood after the operating room that this did result in an occasional clinical disaster, probably related to the infusion of unprocessed cytokines and tissue factor from the wound that enters the mediastinal blood. Do you have any feelings about this, and did you have any similar experiences with patients receiving mediastinal shed blood?

DR MURPHY: This has not been our experience. This was new technology in our unit when we introduced it for this trial, and we therefore had a very low threshold for removing the autotransfuser in patients who showed any signs of bleeding or cardiovascular instability, which has been demonstrated in the fact that 12 patients were withdrawn from the autotransfusion group.

In actual fact, these patients who were apparently bleeding bled whether or not the autotransfuser was used or not, and in no patient was it apparent that autotransfusing blood actually exacerbated anticoagulopathy.

Looking at the data that I haven't shown here because of time limitations, there was no real significant derangement in any one patient's clotting profiles after autotransfusion. I think the modern systems that we use to wash red cells are very effective and they remove much of the tissue factor and the cytokines from the shed mediastinal fluid.

	References

Top Abstract Introduction Patients and methods Results Comment Acknowledgments Discussion References

 

1. Schmidt H., Mortensen P.E., Folsgaard S.L., Jensen E.A. Autotransfusion after coronary artery bypass grafting halves the number of patients needing blood transfusion. Ann Thor Surg 1996;61:1177-1181.[Abstract/Free Full Text]
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3. Martin J., Robitaille D., Perrault L.P., et al. Reinfusion of mediastinal blood after heart surgery. J Thorac Cardiovasc Surg 2000;120:499-504.[Abstract/Free Full Text]
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14. Dalrymple-Hay M.J., Pack L., Deakin C.D., et al. Autotransfusion of washed shed mediastinal fluid decreases the requirement for autologous blood transfusion following cardiac surgery: a prospective randomized trial. Eur J Cardiothorac Surg 1999;15:830-834.
15. Bracey A.W., Radovancevic R., Riggs S.A., et al. Lowering the hemoglobin threshold for transfusion in coronary artery bypass procedures: effect on patient outcome. Transfusion 1999;39:1070-1077.[Medline]
16. Nuttal G.A., Oliver W.C., Ereth M.H., et al. Comparison of blood-conservation strategies in cardiac surgery patients at high risk for bleeding. Anesthesiol 2000;92:674-682.[Medline]
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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Simon M. Allen Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Murphy, G. J. Articles by Dalrymple-Hay, M. J. R. Search for Related Content PubMed PubMed Citation Articles by Murphy, G. J. Articles by Dalrymple-Hay, M. J. R. Related Collections Extracorporeal circulation