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CARDIOVASCULAR ANESTHESIOLOGY

A Randomized Controlled Trial of Cell Salvage in Routine Cardiac Surgery

Andrew A. Klein, MMBS^*, Samer A. M. Nashef, MBChB, Linda Sharples, PhD, Fiona Bottrill, HNC^*, Matthew Dyer, MSc, Johanna Armstrong, PhD^*, and Alain Vuylsteke, MD^*

From the *Department of Anaesthesia and Critical Care and Department of Cardiothoracic Surgery, Papworth Hospital, Cambridge; MRC Biostatistics Unit, Cambridge; and Health Economics Research Group, Brunel University, United Kingdom.

Address correspondence to Dr Andrew Klein, Department of Anaesthesia, Papworth Hospital, Cambridge, CB23 3RE, UK. Address e-mail to andrew.klein{at}papworth.nhs.uk.

Abstract

BACKGROUND: Previous trials have indicated that cell salvage may reduce allogeneic blood transfusion during cardiac surgery, but these studies have limitations, including inconsistent use of other blood transfusion-sparing strategies. We designed a randomized controlled trial to determine whether routine cell salvage for elective uncomplicated cardiac surgery reduces blood transfusion and is cost effective in the setting of a rigorous transfusion protocol and routine administration of antifibrinolytics.

METHODS: Two-hundred-thirteen patients presenting for first-time coronary artery bypass grafting and/or cardiac valve surgery were prospectively randomized to control or cell salvage groups. The latter group had blood aspirate during surgery and mediastinal drainage the first 6 h after surgery processed in a cell saver device and autotransfused. All patients received tranexamic acid and were subjected to an algorithm for red blood cell and hemostatic blood factor transfusion.

RESULTS: There was no difference between the two groups in the proportion of patients exposed to allogeneic blood (32% in both groups, relative risk 1.0 P = 0.89). At current blood products and cell saver prices, the use of cell salvage increased the costs per patient by a minimum of $103. When patients who had mediastinal re-exploration for bleeding were excluded (as planned in the protocol), significantly fewer units of allogeneic red blood cells were transfused in the cell salvage compared with the control group (65 vs 100 U, relative risk 0.71 P = 0.04).

CONCLUSION: In patients undergoing routine first-time cardiac surgery in an institution with a rigorous blood conservation program, the routine use of cell salvage does not further reduce the proportion of patients exposed to allogeneic blood transfusion. However, patients who do not have excessive bleeding after surgery receive significantly fewer units of blood with cell salvage. Although the use of cell savage may reduce the demand for blood products during cardiac surgery, this comes at an increased cost to the institution.

Blood transfusion is associated with well described risks, including infectious disease transmission, hemolytic and nonhemoltyic transfusion reactions, and others.1 Patients undergoing cardiac surgery account for a large proportion of blood transfusions worldwide (10% of all blood transfusions).2 Allogeneic red blood cell (RBC) transfusion during coronary artery bypass grafting (CABG) has been shown to alter immunity3 and to be associated with a greater risk of acute lung injury,4 perioperative myocardial infarction,5 postoperative low-output heart failure,6 and death.7 These risks, along with the limited availability of blood products and the increasing cost of blood transfusion, have heightened interest in blood conservation during cardiac surgery, including the use of transfusion algorithms and antifibrinolytic therapy.8–10

Several studies have reported that cell salvage, in which blood lost during surgery is recovered, processed, and reinfused into the patient, may reduce blood transfusions.11–13 These studies, however, have multiple limitations, including the inconsistent use of antifibrinolytic drugs, the failure to include transfusion guidelines, and the inclusion of multiple comparison groups such as those undergoing normovolemic hemodilution. In addition, continuing the use of cell salvage from the operating room into the postoperative period, in order to maximize yield, has not been studied. The majority of these studies did not include patients undergoing valve surgery with or without combined CABG, procedures that account for an increasing proportion of cardiac surgery (more than 50% of elective surgery at our institution) limiting the generalizability of the data to everyday practice. Further, previous studies have not included a comprehensive, prospective, cost-benefit analysis of cell salvage, as recommended by the Cochrane group.14

Therefore, we conducted a prospective, randomized controlled trial to examine the hypothesis that the use of cell salvage during and after routine cardiac surgery would reduce the proportion of patients exposed to allogeneic blood transfusion. We further sought to examine the cost benefits of cell salvage use and whether this technique might benefit certain subgroups of cardiac surgical patients.

METHODS

Participants
The study was approved by the Research and Ethics Committee of Papworth Hospital, Cambridge, UK and all patients provided written informed consent All patients scheduled for nonemergency first-time CABG, valve surgery or combined CABG, and valve procedures requiring cardiopulmonary bypass (CPB) were eligible for enrolment. Exclusion criteria were: patient refusal to receive blood or blood products; previous cardiac or thoracic surgery; known coagulation disorders; contraindication to antifibrinolytics; participation in another trial of an investigational drug or device; or specific request for cell salvage by the operating surgeon. Operations associated with a high risk of transfusion, such as transplantation and operations on the thoracic aorta were excluded.

Randomization
Patients were allocated to the cell salvage or control group by simple randomization generated by an independent statistician using a computer random number function, stratified by type of surgery. Group allocation was determined on admission to hospital the day before surgery and was held in the hospital research unit until the patient gave consent and was registered. Due to the nature of the intervention, group allocations were necessarily made available to operating room and intensive care unit (ICU) staff managing the patients.

Perioperative Care
All patients received standard premedication (morphine 0.2 mg/kg and hyoscine 0.3 mg) and anesthesia that included fentanyl 15 µg/kg, pancuronium 0.15 mg/kg, propofol, and isoflurane. Tranexamic acid 2 g was administered IV after anesthesia induction. Before CPB, heparin 300 U/kg was given to achieve an activated clotting time (ACT) >400 s, with additional boluses of 5000 U if the ACT decreased below 400 s at any point. All patients were placed on CPB (Stockert-Sorin S3; Sorin Biomedica, Mirandola, Modena, Italy), using an uncoated membrane oxygenator (CapioxRX25, Terumo, Tokyo, Japan); blood cardioplegia was used (warm or cold depending on surgical preference) and blood gases were recorded half-hourly throughout (-stat).

During surgery, allogeneic RBCs were transfused for a hemoglobin <7 g/dL. Postoperatively, allogeneic RBCs were transfused for hemoglobin <8.0 g/dL. In the cell salvage group (see below), allogeneic blood was only transfused if there were no available RBCs from the cell salvage processing. After CPB, protamine was given at a dose matching the prebypass dose of heparin (1 mg protamine per 10 U heparin). Further protamine was administered in 50 mg bolus doses if the ACT was > baseline ACT + 10%.

The patients were transferred to the ICU and weaned from mechanical ventilation according to standard institutional protocol. If chest tube drainage exceeded 3 mls · kg^–1 · h^–1, coagulation testing and full blood count were performed and, if abnormal, fresh frozen plasma (FFP), cryoprecipitate, or platelets was transfused according to protocol (Fig. 1). The decision for resternotomy for bleeding was made by the operating surgeon.

View larger version (19K): [in this window] [in a new window]   Figure 1. Transfusion protocol. ACT = activated clotting time; PT = prothrombin time; Hb = hemoglobin; FFP = fresh frozen plasma.

Cell Salvage Procedures
The cell salvage apparatus (CATS - Fresenius Hemocare, France) was prepared before the start of surgery, and it was used exclusively for surgical suction before and after CPB in the cell salvage group. After weaning from CPB, blood remaining in the CPB circuit was processed by the cell saver device, which was operated by the anesthetic technicians. All recovered blood, with no minimum volume due to the design of the cell salvage device, was transfused to the patient. Postoperatively, the cell saver was transferred with the patient to the ICU and connected to the chest tubes. All blood lost during the first 6 h was processed by the ICU nurses hourly and the blood autotransfused. Cell salvage was discontinued after 6 h unless resternotomy was required, in which case it was continued intraoperatively and for a further 6 h (a new circuit was set-up during the second operation).

Control Group
In the control group, blood aspirated from the mediastinum during surgery while the patients was heparinized was returned to the CPB reservoir. Otherwise, all blood suctioned before and after CPB was discarded. After CPB, any remaining blood in the bypass machine tubing and reservoir was collected in a bag and transfused directly to the patient.

Outcomes
The primary outcome of the study was any allogeneic blood transfusion. Secondary outcomes were the number of units of RBCs, FFP, or platelets transfused. Serious adverse events, hematology, and biochemistry variables (sampled preoperatively and at 1 h, 24 h, and 5 days after operation) were recorded to monitor safety.

Cost Analysis
Cost analysis was conducted using resource use data collected prospectively from randomization until 30 days after admission. The evaluated variables included duration of surgery, length of hospitalization in the ICU and postoperative ward, drug use, readmission after initial hospital discharge, and visits with the general practitioner and home health nurse. These data were collected by the trained research staff (FB and JA), by analyzing patient charts and administrative databases, and contacting the family doctor of every patient. All patients were successfully followed-up. All resources were valued at prevailing 2006/07 costs obtained from National estimates (UK Department of Health) or Papworth Hospital NHS trust. Costs were then converted from UK £ sterling to United States $ using the latest available Gross Domestic Product purchasing power parities.

The cost of cell salvage ($153 per patient) included the supply of the cell salvage machine and consumables, servicing, repairs and training, based on a throughput of 300 patients per year. In the purchase scheme, the cost was the annual equivalent cost of the cell salvage machine plus maintenance costs, consumables and training, based on throughput of 300 patients per year. The cost of blood products was obtained from the National Blood Service.15 The costs per unit of RBC, FFP, and platelets were $200, $49, and $328 respectively. Cross-match charges for each unit of RBC were $19 and the cost of issuing each unit of FFP and platelets was $3.

Papworth Hospital finance department supplied the costs for the operating room, the ICU, and ward bed day costs. These included standard tests, consumables, staff, and overhead costs. All cardiac drug costs were obtained from the British National Formulary.16

Data on adverse events were recorded for 30 days after surgery. These included any return to the operating room for bleeding, any additional cardiac-related procedures or diagnostic tests, readmissions to ICU during the initial hospitalization and any readmissions to the hospital (including emergency ward visits). The costs of any general practitioner or nurse visits, emergency ward visits, and readmissions to other hospitals were calculated according to national estimates, which are calculated and checked for accuracy on an annual basis.17,18

Sample Size Estimate
Continuous blood transfusion audit data showed that 50% of patients undergoing CABG and/or valve surgery required allogeneic blood transfusion in the year preceding the design of the trial. A priori we assumed a reduction in the patients receiving transfusion to 30% due to cell salvage.11 Based on a two-sided significance level of 5%, a sample size of 206 patients (103 in each group) would provide 80% power to detect this difference.

Statistical Analysis
Intraoperative and immediate postoperative measurements were compared using the Pearson ² test, the Student's t-test or the Mann-Whitney U-test as appropriate.

The primary outcome was exposure to allogeneic blood. The primary analysis was by intention-to-treat and the proportions of patients in each group who required allogeneic blood were compared using a Pearson ² test. The amount of blood products used (in units) was analyzed using Poisson regression due to the highly discreet nature of the measurement.

For other continuous parameters measured after surgery, the effect of cell salvage was assessed within a linear regression, which included baseline measurements. Blood loss was summarized as median and interquartile range, with groups compared using the Mann-Whitney U-test. A predefined secondary analysis of all data was conducted, excluding the small proportion (<5%) of patients who returned to the operating room for bleeding, since these patients may not be distributed equally between treatment and control groups and they may require far larger (and unequal) amount of transfusion, thus potentially skewing the study results.

RESULTS

Baseline Characteristics and Intraoperative Data
Patient progress through the trial is summarized in Figure 2. Of the 213 patients randomized between June 2005 and April 2007, 102 were allocated to cell salvage group and 111 to the control group. In the cell salvage group, 5 patients (4.9%) did not receive the intervention due to lack of trained site staff (2), operation cancellation (2), and equipment failure (1). In the control group, 2 patients (1.8%) received cell salvage after surgical request due to unexpected heavy bleeding in the operating room. For the intention-to-treat analysis, these patients were included in their randomized group. Baseline characteristics and operative details are summarized in Table 1. There were no differences between groups in the listed variables including the operative risk as measured by logistic EuroSCORE.19 Two control patients and three cell salvage patients had resternotomy for postoperative bleeding. The median ICU stay was 1 day and the median postoperative hospital stay was 7 days in both groups.

View larger version (17K): [in this window] [in a new window]   Figure 2. CONSORT Diagram showing the flow of participants through each stage of the trial comparing cell salvage with standard management (control). CS = cell salvage.

There was no difference in the mean (sd) heparin dose between the two groups (cell salvage group, 27,113 U [5785] versus control group, 28,032 U [5406], P = 0.232). The mean (sd) protamine dose was lower in the cell salvage group compared with the control group (272.4 mg [73.0] vs 299.5 [67.0], P = 0.006). There were no significant differences between the groups in ACT before, during, or after CPB. The mean volume of processed blood returned in the operating room in the cell salvage group was 342 mls (SD 194). A smaller volume was returned in ICU during the 6 h of use (mean 80 mls [SD 224]).

Transfusion Outcomes
There was no difference in the proportion of patients receiving an allogeneic blood transfusion between the two groups (Table 2). There was also no difference in the amount of blood and blood products administered to both groups. On secondary analysis, excluding the 5 patients who returned to the operating room for bleeding, RBC transfusion was less in the cell salvage group (65 vs 100 U, relative rate 0.71 [95% CI 0.52–0.97], P = 0.04).

Postoperative Hematology and Biochemistry
The majority of hematology and biochemistry measurements were similar between the groups. The mean hemoglobin was 13.5 gm/dL in both groups preoperatively and decreased to 8.8 (sd 3.9) gm/dL at 1 h and 9.9 (sd 2.8) gm/dL at 5 days in the cell salvage group compared with 9.5 (sd 2.9) gm/dL and 9.8 (2.7) gm/dL, respectively, in the control group. The cell salvage group did have a lower platelet count (P = 0.01) and a lower fibrinogen level (P = 0.03) 1 h postoperatively compared with the control group, but these measurements were not different by 24 h and 5 days after surgery (Figs. 3 and 4). Despite this, there was no difference in postoperative blood loss between the two groups in the first 6 h as listed in Table 2 (172 mls in the cell salvage group versus 175 mls in the control group, P = 0.10).

View larger version (6K): [in this window] [in a new window]   Figure 3. Difference in mean platelet count. The y axis is the difference in platelet count between the cell salvage and the control groups; the x axis is the time of sample measurement postoperatively. The mean and sd are plotted. The platelet count in the cell salvage group is lower (P = 0.01) 1 h postoperatively (by 19 x 109).

View larger version (6K): [in this window] [in a new window]   Figure 4. Difference in mean fibrinogen level. The y axis is the difference in fibrinogen level between the cell salvage and the control groups; the x axis is the time of sample measurement postoperatively. The mean and sd are plotted. The fibrinogen level in the cell salvage group is lower (P = 0.03) 1 h postoperatively (by 0.3 mg/dL).

Cost Analysis
Cost analysis results are presented in Table 4. The use of cell salvage resulted in higher mean total costs but these did not reach statistical significance (P = 0.16). The majority of the cost for both groups, not surprisingly, was due to operating room time and hospital stay. Blood transfusion products accounted for only 1% to 2% of the total cost in the two groups. The analysis was also repeated to exclude all other costs except the costs of the cell salvage and blood products consumed within both groups. This analysis showed that cell salvage resulted in a minimum of $103 per patient increase in costs compared with the control group.

DISCUSSION

Our results show that the use of cell salvage in patients undergoing nonemergent first-time cardiac surgery, did not reduce the number of patients exposed to allogeneic blood transfusion. When considering only patients not requiring reoperation for postoperative bleeding, we did find a reduction in the number of units of allogeneic blood transfused in the cell salvage group compared with the controls. Patients in the cell salvage group had a lower platelet count and fibrinogen level 1 h postoperatively, but there was no difference in postoperative bleeding between the two groups.

A strength of this randomized study was the standardization of clinical practice between groups, with all patients receiving tranexamic acid to reduce surgical bleeding and blood transfusions,20 the use of a transfusion algorithm, and the restriction of eligibility for study enrolment to a relatively homogeneous population. The trial design was simple (only one intervention was studied) and adequately powered. Cost analysis was performed in a prospective manner as part of the trial protocol.

The proportion of patients who received allogeneic blood transfusion in this study was 32% in both groups. This is lower than our a priori estimates of 50% used for our power calculation, and at variance with other studies. This reduced blood transfusion rate may have resulted from a number of factors, including the lowering of the postoperative hospital-wide transfusion threshold from a hemoglobin of 8.5 to 8 gm/dL and a more restrictive patient selection criteria applied in an experimental study than in our usual clinical practice. Adherence to transfusion protocols may have improved due to education and regular audits performed to ensure compliance. A greater surgical attention to hemostasis may have occurred (as demonstrated by lower resternotomy incidence from 8% 5 yr ago to 2.5% in this study), and the standardized use of tranexamic acid (as opposed to sporadic use in the years leading up to the trial) may all have contributed to the lower than expected transfusion rates. Regardless, the lower than expected rate of blood transfusion may have led to a type II error in our study, or excluding a transfusion-sparing benefit with cell salvage when there might actually be such a benefit.

Our finding of a lack of effect in reducing exposure to allogeneic blood with cell salvage is inconsistent with previous studies. However, these other results may have been influenced by variables other than cell salvage usage such as nonstandardized protocols for antifibrinolytic therapy11–13,21 or transfusion.22 Our report of a lower blood transfusion rate than in previous studies of cell salvage may imply a relationship between the amount of allogeneic blood transfusion used and the effectiveness of cell salvage for reducing this transfusion rate. Finally, our results cannot be generalized to off-pump cardiac surgery where cell salvage has been demonstrated to reduce blood transfusion23 and to more complex procedures such as repeat sternotomy or aortic surgery, where there is likely more blood loss than in this study.

Implications of the Findings
When we eliminated patients requiring immediate reoperation for postoperative bleeding from the analysis, we did find a reduction in the number of units of packed RBCs transfused in the cell salvage group compared with controls (0.66 U vs 0.92 U per patient, P = 0.04). For a cardiac surgical unit performing 1000 operations per year, 260 fewer units of allogeneic RBC transfusions would result from the routine use of cell salvage. This reduction in RBC transfusion was not associated with an increased use of other blood products, although this has often been proposed as an inevitable consequence of cell salvage usage.24 This reduction in allogeneic blood use has public health implications by reducing costs and by reducing demands for increasingly scarce blood products that is resulting from a reduction in the donor pool.25

Our blood conservation approach included processing of the remaining CPB blood volume at the conclusion of surgery and the chest tube blood drainage the first 6 h after surgery. Cardiotomy blood was returned to the CPB pump in both groups, as cell salvage of this blood has been shown to increase the number of blood transfusions,26 however, this may be associated with reduced postoperative neurocognitive dysfunction.27 A mean volume of 342 mls was autotransfused in the operating room and an average of 80 mls was returned in the ICU. Together, the equivalent of nearly 2 U of allogeneic packed RBCs was transfused to each patient in the cell salvage group (assuming a volume of 250 mL per 1 U of packed RBCs). Although the hemoglobin concentration on admission to the ICU was not different between groups, there was a trend for hemoglobin to be higher in the cell salvage group compared with the controls 24 h later (hemoglobin 10.4 gm/dL and 10.1 gm/dL, respectively, P = 0.06). Nonetheless, our study was not powered to detect differences in hemoglobin concentration between groups. The relatively small volume of blood loss in the first 6 h after surgery (175 mL) implies that there is little clinical benefit to routinely extending cell salvage use after cardiac surgery. Its use might still be considered for cases where larger blood loss is observed, although our study did not specifically evaluate this situation.

The volume of blood remaining in the CPB circuit at the conclusion of surgery varied between 500 and 1500 mls. Processing this blood with cell salvage increases the hematocrit of this blood before autotransfusion, but it removes the plasma (containing coagulation factors) and platelets. In our study, we did not observe an increased risk of postoperative bleeding with cell salvage use compared with controls. In the cell salvage group, the mean decrease from baseline in platelet count and fibrinogen was small and unlikely to be clinically important. The larger dose of protamine required in the control group is likely explained by the transfusion of unprocessed blood from the CPB circuit containing heparin leading to an increase in ACT.

Cost Analysis
Costs associated with transfusion account for only a small percentage of the total hospital costs associated with cardiac surgery. These costs may increase in the future due in part to reduced blood supply resulting in an increase in processing cost per unit. However, based on this study, cell salvage appears to be more expensive than allogeneic transfusion alone. We found that the cost of 1 U of RBCs would have to exceed $460 before cell salvage would be cost-neutral (assuming the scheme cost remains unchanged). There is a considerable variation in the cost of different cell salvage equipment and disposables, and these costs are also likely to vary across institutions. More complex systems may require operation by specialized staff, which will add to the expected costs. Additionally, some systems may not offer the flexibility of use in the operating room and ICU, requiring the purchase of more than one system. Finally, our small study and related low rates of complications may not allow for consideration of any long-term costs of transfusion, such as those related to transmission of infectious diseases.

CONCLUSION

These data suggest that the routine use of cell salvage in primary, nonemergent cardiac surgery does not reduce allogeneic blood transfusion. Further, the use of cell salvage was found to add expense compared with controls. We did find a reduction in the number of units of RBCs transfused with cells salvage use compared with controls, for patients not experiencing excessive postoperative bleeding requiring resternotomy.

ACKNOWLEDGMENTS

The authors thank the anesthetic research unit and R&D staff at Papworth Hospital, and particularly Caroline Gerrard, who contributed to data collection and collation during the trial. We would also like to thank all the patients who kindly agreed to take part and all the staff involved in their care.

Footnotes

Accepted for publication April 11, 2008.

Supported in part by an unrestricted educational grant from Fresenius, CATS manufacturer and by anesthetic research unit at Papworth Hospital.

Trial registration: ISRCTN: International standards randomized controlled trial number: 17615029.

Research ethics committee number: 05/Q0106/19.

Reprints will not be available from the author.

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