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Ann Thorac Surg 1995;59:730-735
© 1995 The Society of Thoracic Surgeons
II Cardiac Surgery Department and Transfusion Service, Spedali Civili, Brescia, Italy
Accepted for publication December 8, 1994.
| Abstract |
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| Introduction |
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During the last decades, many techniques have proved to be useful for this purpose [5]. Acute normovolemic hemodilution [6], acute preoperative plasmapheresis [7], reinfusion of shed mediastinal blood [8], and the use of pharmacologic agents such as aprotinin [9] or erythropoietin [10] all have been shown to be highly effective in reducing blood use during and after cardiac operations. Recent reports underline the efficacy of combining these techniques in a blood conservation program to further decrease blood use [1113] and therefore also to decrease the risk of blood-related infections.
Preoperative autologous donation (PAD) has been considered an effective blood-saving method; several reports underline its efficacy in decreasing use of homologous blood products both in cardiac surgery and in other surgical disciplines [1417].
In this report, we examine the impact of a PAD program in our clinical practice and look at whether or not this procedure is compatible with other blood conservation measures and, consequently, if it is to be considered in the setting of a comprehensive blood conservation program in cardiac surgery.
| Material and Methods |
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Predonation Program
Patients scheduled for elective operations were asked preoperatively to enter the predonation program. Inclusion criteria included hemoglobin values greater than 12 g/dL and an age limit of less than 70 years. Following Goodnough's guidelines [18], exclusion criteria were unstable angina or symptoms of disease on the day of donation, severe aortic stenosis with valve area less than 0.8 cm2, congestive heart failure, left main coronary artery disease, congenital cyanotic heart disease, and hematologic diathesis. All patients were asked to give detailed information regarding modifications in their cardiac symptoms. Predonation and intradonation blood pressure and pulse rate were monitored. Each donation consisted of about 300 to 350 mL of blood (1 unit) and usually was completed within 15 minutes. All the autologous blood was collected in silicone bags containing CPDA 1 (citrate, phosphate, dextrose, adenosine). The predonation procedure was carried out from 30 to 7 days before the operation.
After the first unit of blood was taken, we considered whether to ask further predonations of up to three units per patient in case of hemoglobin values greater than 12 g/dL and of clinical stability. Once collected, the autologous blood was processed to obtain red blood cell (RBC) concentrates and fresh frozen plasma. In the absence of clinical contraindications, we suggested oral iron supplementation (325 mg three times daily) up to the operation date. No erythropoietin or intravenous iron therapy was considered in this patient population. All patients attending PAD were asked to sign informed consent before the first donation.
Blood Conservation Program
SURGICAL HEMOSTASIS AND CARDIOPULMONARY BYPASS.
Meticulous surgical hemostasis was considered the very first step in preventing postoperative blood loss. Before protamine administration, all surgical bleeding points were controlled and particular care was taken when internal thoracic arteries were used.
Clear priming of the cardiopulmonary bypass circuit was applied routinely, and global volume was reduced according to the patient's body mass and oxygenator performance to diminish systemic hemodilution. Cardiopulmonary bypass was carried out with membrane oxygenator in all patients.
AUTOTRANSFUSION PROTOCOL.
According to the preoperative conditions, patients were evaluated for the possibility of performing acute normovolemic hemodilution immediately after anesthesia induction. Exclusion criteria were hemodynamic instability after induction or hematocrit values less than 36%. In eligible patients, one or two units (300 and 600 mL, respectively) of whole blood was collected, stored at room temperature, and reinfused after heparin protamine reversal.
At the end of extracorporeal circulation, blood residual of the pump was processed by a cell separator to obtain washed red blood cell concentrate, which was reinfused routinely to increase hematocrit value.
Shed mediastinal reinfusion was accomplished within 6 hours after operation in case of substantial bleeding (ie, more than 100 mL/h).
APROTININ.
Low dose aprotinin (2 million KIU) was added to the priming of the cardiopulmonary bypass machine in patients with a high risk of intraoperative and postoperative bleeding, namely those undergoing a second or third cardiac operation, those who had not stopped receiving antiplatelets agents at least 2 weeks before the operation, and patients affected by endocarditis.
Transfusion Guidelines
General transfusion guidelines [18] were followed during and after operation for both groups. Red blood cell concentrates were used to increase hematocrit values on an individual basis for each patient according to his or her clinical condition and type of operation. We allowed hemodilution to a hematocrit of 18% on cardiopulmonary bypass while hemoglobin values less than 8 g/dL was considered a general threshold for transfusion of RBC in the postoperative period. Fresh frozen plasma was used to correct hemostatic unbalance with altered coagulation tests (prothrombin time ratio greater than or equal to 1.5 times control or partial thromboplastin time greater than 40 seconds or both) after extracorporeal circulation. Platelet concentrates were transfused in case of bleeding with concomitant severe thrombocytopenia (platelet count less than 100,000 µL).
Considering the risks related even to autologous blood transfusion (infection, human error), we did not freely give back to group 1 patients their own blood, but used autologous units with similar transfusion threshold with respect to group 2. In addition, we did not practice autologous ``cross-over'' [19], and as a consequence, we assumed that unused autologous blood was not to be made available to other patients.
Statistical Analysis
Differences between the two groups were analyzed by means of two-tailed Student's t test for continuous variables and
2 analysis for categoric variables. Values are presented as mean ± standard deviation of the mean. A stepwise multivariate logistic regression analysis was used to determine the key predictors of the need for homologous blood. Variables included in the analysis are listed in Appendix 1. Differences were considered to be significant at p values of less than 0.05.
| Results |
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| Comment |
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Autologous blood predonation has been pointed out as safe and effective in avoiding or decreasing homologous blood product transfusions during and after cardiac operations even in patients once considered not eligible for this procedure [16, 22]. The present study was designed to verify the real clinical impact of a blood predonation program and to see whether PAD was safe and effective in sparing homologous blood products and was compatible with other blood-saving measures. The only difference between the two groups compared in this study was the availability of predonated autologous blood; the other blood-saving measures were used according to the preestablished norms.
Group 1 patients were admitted for operation with a significantly lower hemoglobin value. This is of course related to preoperative blood collection and, as a consequence, group 1 patients had lower application of acute normovolemic hemodilution both in the number of patients and in the average donation per patient. Platelet count was lower in group 1 as well. Nevertheless, bleeding after operation was similar in both groups even in the first hours after operation, proving that autologous predonation does not produce hemostatic unbalance and can compensate and be even better than acute normovolemic hemodilution. Other blood-saving techniques such as reinfusion of shed mediastinal blood and of the residual of extracorporeal circulation were accomplished in both groups in a similar manner. On this view, predonation is compatible with and does not exclude the application of other techniques designed for allogenic exposure reduction except for acute normovolemic hemodilution, which was applicable in a lower number of patients from whom on the average was withdrawn a lower quantity of blood.
Patients with autologous predonation had a marked average reduction of banked blood use. Better results were obtained in patients with three available units, in whom the risks of transfusion exposure were nearly zero, whereas patients with only 1 unit showed no difference in terms of homologous blood exposure when compared with the nondonor population.
Owings and colleagues [15] showed that good results in terms of global and homologous transfusion were obtained in patients by whom three units of autologous blood were predonated. Our experience confirms that donation of three units prevents excessive hemodilution and is nearly always sufficient to cover blood needs after an open heart operation. Patients with two available units have a relative decrease in transfusion rate as well, but not equal to those with three units. Patients with only one autologous unit available had no differences in terms of allogenic blood exposure when compared with the control population. This must be taken into account in programming donation stages because too short a time available for the withdrawal is one of the main reasons for deferral. We think that starting with the first donation at least 3 weeks before operation could allow a greater number of patients to complete the program.
Although oral iron therapy was suggested during the course of predonation, most of the deferrals were due to low hemoglobin values. We did not speculate on this problem, but probably a more aggressive iron therapy in selected patients could be considered. In any case, the time available for oral iron therapy during the course of predonation seems to be too short to change anemic patterns and to increase hemoglobin values significantly [23].
Taking into consideration the frequency distribution of RBC concentrate transfusions, we found that the great majority of the transfused patients in group 2 received one to three units of homologous blood. This is a strong suggestion that those patients could have avoided any contact with donor blood if they had entered and completed the predonation program.
In our present study, the patient population is quite heterogeneous to reflect the entire spectrum of daily cardiac surgical procedures. In this heterogeneous population, the principal determinants of postoperative blood requirements were total blood loss, advanced age, and the absence of autologous predonated blood. Excluding this last variable, the others were equal in both groups, thereby demonstrating the groups' comparability. Other well-known factors determining blood consumption such as advanced cardiac disease and urgent/emergency operation were not included in the variable list because they were exclusion criteria for total patient enrollment.
From our experience, autologous predonation has proved to be a safe procedure. Among the patients enrolled in the program, only 4 had mild angina symptoms without clinical relevance immediately after donation and underwent coronary artery operation as scheduled. Selection of the patients seems to be crucial for preventing complications. Strict observation of the inclusion criteria avoided a higher complication rate.
Birkmeyer and associates [24] stated that cost-effectiveness of PAD must be reconsidered. However, as a result of our experience, we can affirm that PAD, with very low adjunctive costs to the total price of a cardiac operation, can almost completely avoid the use of banked blood and, as a consequence, reduce the need for donors.
A number of limitations of this study should be considered. This is a nonrandomized study in which subjective consideration led to the donation of autologous blood. Nevertheless, the aim of our study was not only to verify the effectiveness of PAD, which already has been established, but rather to verify the clinical impact of this technique on a daily surgical practice and its compatibility with other blood conservation measures.
The study design was limited by the fact that blinding for the availability of autologous blood was not possible. Nevertheless, the same transfusion criteria were followed for both groups, resulting in comparability for decision-making for transfusion.
Oral iron therapy was suggested but actually few patients made use of it. A randomized study involving the use of iron therapy during the donation period is now being carried out in our institute to see whether there is a significant difference in the amount of blood donated.
In conclusion, our results suggest that wide application of a preoperative donation program could markedly decrease the use of banked blood in cardiac operations with very low procedural risks and that this procedure is compatible with other blood-saving measures with the result of further decreasing the need for allogenic blood products. The initiation of a predonation program as part of a comprehensive blood conservation program resulted in a drastic decrease in our use of homologous blood.
| Appendix 1. Variables Included in Multivariate Analysis |
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Age
Sex
Body surface area
ABO group
Preoperative hemoglobin level
Preoperative platelet count
Left ventricular ejection fraction
Prior cardiac surgical procedure
Autologous predonation
Operative variables
Extracorporeal circulation time
Aortic cross-clamp time
Type of operation
Coronary artery bypass grafting
Valve repair/replacement
Combined valve and coronary artery operation
Atrial septal defect
Number of distal anastomoses
Use of internal thoracic arteries
Use of acute normovolemic hemodilution
Use of aprotinin
Postoperative variables
Blood loss at 6 and 24 hours
Total blood loss
Reinfusion of blood residual of the pump
Use of shed mediastinal reinfusion
24-hour postoperative hemoglobin values
Hospital discharge hemoglobin values
Hospital discharge platelet count
Postoperative blood products transfusion
Red blood cell concentrate
Fresh frozen plasma
Platelet concentrate
| Footnotes |
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| References |
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