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Ann Thorac Surg 1998;65:724-730
© 1998 The Society of Thoracic Surgeons

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Original Articles: Cardiovascular

Reduction of Allogeneic Blood Transfusions After Open Heart Operations by Lowering Cardiopulmonary Bypass Prime Volume

Department of Cardiothoracic Surgery, Boston Medical Center, Boston, Massachusetts, USA

Accepted for publication September 18, 1997.

Dr Shapira, Department of Cardiothoracic Surgery, Boston Medical Center, 88 E Newton St, Boston, MA 02118 (e-mail: oshapira@acs.bu.edu).

	Abstract

Top Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
Background. Despite recent advances in blood conservation techniques, up to 30% to 80% of patients undergoing open heart operations require allogeneic blood transfusions. A prospective, randomized study was performed to test the effect of lowering cardiopulmonary bypass prime volume (as an additional component of an integrated blood conservation strategy) on clinical outcome and allogeneic blood transfusion.

Methods. One hundred fourteen patients undergoing open heart operations were randomized to either full prime (FP) volume (1,400 mL of Plasmalyte solution) or reduced prime (RP) volume (600 to 800 mL). The reduction of prime volume was achieved by slowly draining the cardiopulmonary bypass circuit into a cell-saving device before the initiation of bypass. Firm transfusion thresholds were observed.

Results. There were no significant differences between the groups with respect to baseline characteristics, body surface area, type and urgency of the procedures, perfusion technique, and hematologic profile. Mortality (FP, 1.7%; RP, 0%; p 1.0) and overall morbidity (FP, 28.1%; RP, 22.8%; p = 0.53) were similar. However, transfusion requirements were significantly lower in the RP group: total donor exposure, 3.8 ± 10.1 versus 1.0 ± 2.4 units (p = 0.044); percentage of patients transfused, 54% (n = 31) versus 35% (n = 20) (p = 0.036). Twenty-four–hour chest tube drainage was similar: 455 ± 223 mL for FP versus 472 ± 173 mL for RP (p = 0.66). The lowest hematocrit on bypass was significantly higher in the RP group: 29.3% ± 4% versus 26.3% ± 5.3% (p = 0.009).

Conclusions. Lowering cardiopulmonary bypass prime volume resulted in a significant decrease in allogeneic blood product use. Because postoperative 24-hour chest tube drainage was similar in both groups, and hematocrit during bypass was higher in the RP group, the reduction in allogeneic blood transfusions appears to be related to a decrease in prime-induced hemodilution. This technique is effective, simple, and safe. It therefore should be strongly considered for patients undergoing operations using normothermic or near-normothermic cardiopulmonary bypass who are at high risk for allogeneic blood transfusion.

	Introduction

Top Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
Despite recent advances in blood conservation techniques, up to 30% to 80% of patients undergoing open heart operations require allogeneic blood transfusions [1][2]. Techniques most commonly employed include use of heparin-bonded cardiopulmonary bypass (CPB) circuits [3] with a large-bore directional arterial cannula [4]; conduct of near-normothermic bypass [5], refined heparin/protamine titration techniques [6]; cell saving, preoperative autotransfusion, and postoperative transfusion of shed mediastinal blood [7][8]; and a variety of pharmacologic interventions, most notably aprotinin, aminocaproic acid, and tranexamic acid [9].

A certain degree of hemodilution is inevitable with the current CPB technique, where crystalloid solutions have replaced homologous blood for CPB circuit priming [10]. The magnitude of hemodilution depends on the volume of crystalloid solution used for priming, and the patient’s baseline blood volume and hematocrit. Low preoperative hematocrit and small body surface area (ie, low red blood cell mass) have been previously demonstrated to be significant independent predictors of perioperative allogeneic blood transfusion [3][11][12]. These observations may at least be partially related to extreme hemodilution induced by a large fixed crystalloid prime volume. More than three decades ago Panico and Neptune [13] described a method of reducing the CPB crystalloid prime by substituting it with the patients’ own blood. A modification of this technique was recently described by Rosengart and associates [14] in a small group of patients undergoing first-time coronary artery bypass. Using similar principles, this study was designed to examine whether lowering CPB prime volume will reduce the degree of hemodilution and therefore the need for allogeneic blood transfusion in an unselected group of patients undergoing open heart operations.

	Patients and Methods

Top Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
Patients
One hundred fourteen consecutive patients undergoing open heart operations at the Boston Medical Center were randomized to either full prime volume (FP) (1,400 ml of Plasmalyte solution [Travenol, Baxter, Irvine, CA]) or reduced prime volume (RP) (600 to 800 mL). The study was approved by the Boston Medical Center Institutional Review Board for Human Research (Institutional Review Board protocol no. E4028; approval date, March 6, 1996), and informed consent was obtained from each participant. This study compares the transfusion requirements, hematologic data, and clinical outcomes of these two groups.

Cardiopulmonary Bypass Techniques
The components of the CPB circuits were identical for both groups. A large-bore (20 to 22F) directional cannula was used for arterial perfusion. A two-stage 36F atrial cannula was used for coronary artery bypass grafting and aortic valve operations, and separate 34F venae cavae cannulas for mitral and tricuspid valve operations. A centrifugal pump with a hollow-fiber oxygenator and ionically bonded heparin CPB circuits (Duraflo II; Baxter, Irvine, CA) were used in all cases. Patients were not actively cooled, and the temperature was not allowed to drift to less than 34°C. Field blood was aspirated to a cardiotomy pump sucker during CPB, and to a cell-saving device (Haemonetics Corp, Braintree, MA) before and after CPB. Discard suckers were not used. All sponges were soaked in saline solution and wrung into a reservoir, and the drainage was directed to the cell-saving device.

Prime Volume
In the FP group the CPB circuits were primed with 1,400 mL of Plasmalyte solution. In the RP group the circuits were primed initially with the same volume. However, before initiation of bypass, part or the entire crystalloid prime was slowly drained into a cell-saving device with using a Y connector. The crystalloid prime was replaced by retrograde filling of the circuit with the patient’s blood, while the patient’s hemodynamics were carefully monitored. The venous side of the circuit was drained first, followed by retrograde drainage of the arterial side. The drainage was discontinued when the patient’s systolic blood pressure fell to less than 90 mm Hg, or the mean blood pressure to less than 55 mm Hg. Use of vasopressors to allow drainage of higher volumes was strictly avoided. With this technique the crystalloid prime volume was reduced to an average of 653 ± 128 mL.

Anticoagulation
In both groups heparin and protamine administration were monitored by a dose-response assay using the Hepcon Heparin management system (Medtronic Inc, Minneapolis, MN). In patients undergoing coronary artery bypass grafting 100 USP/kg of heparin was given to achieve and maintain an activated clotting time greater than 280 seconds. In patients undergoing valve procedures an initial dose of 300 USP/kg was given to achieve and maintain an activated clotting time greater than 480 seconds. The activated clotting time was measured every 20 minutes during CPB.

Myocardial Protection
Myocardial protection was achieved using antegrade and retrograde cold (4°C) blood cardioplegia, supplemented by topical cooling with cold saline solution. The cardioplegic solution was administered as an initial bolus and every 20 minutes. Before each cardioplegia dose the stagnant volume was discarded into the field.

Weaning From Cardiopulmonary Bypass
Patients were actively warmed to 37°C (measured by urinary bladder temperature probe). After weaning off CPB, a protamine test dose was given (Elkins-Sunn, Cherry Hill, NJ). After we verified that there were no adverse effects to protamine administration, the cannulas were removed. In both groups the blood in the arterial, venous, cardioplegia, and pump sucker lines was promptly drained to a cell-saving device, simultaneously refilling the circuit with crystalloid solution. Thus, blood stagnation was avoided, but the circuit remained available for immediate reuse if necessary.

Aminocaproic Acid
Aminocaproic acid (Amicar; American Reagent, Shirley, NY) was used in this study as a routine part of our integrated blood conservation strategy [3][15]. This was based on previous studies showing that it use was associated with decreased blood loss and blood transfusion requirements [10]. A 10-g intravenous loading dose of Amicar was administered over 30 minutes after weaning off CPB, followed by a continuous infusion of 10 g intravenously over 5 hours. The drug was administered only after bypass to avoid a hypercoagulable state because a heparin-bonded circuit and low systemic anticoagulation protocol were used in most cases.

Transfusion Guidelines
In addition to clinical evaluation, departmental thresholds for allogeneic blood transfusion were defined as a hematocrit of 20% during CPB and 25% postoperatively. Use of clotting factors (platelets, fresh frozen plasma, cryoprecipitate) was based on clinical assessment of bleeding and hematologic evaluation, specifically correcting factor deficits. Persistent bleeding in excess of 300 mL in the first hour or 500 mL in the first 2 hours was considered an indication for transfusion of 5 to 10 units of platelets and 2 to 4 units of fresh frozen plasma. In the absence of clinically significant bleeding, abnormal platelet count, prothrombin time, or partial thromboplastin by themselves did not trigger transfusion. The departmental transfusion guidelines were rigid and did not change over the study period.

Data Collection
All data were prospectively collected. Data collected included (1) demographic information; (2) preoperative left ventricular ejection fraction and functional status determined by the New York Heart Association classification; (3) comorbid risk factors; (4) operative data, including type of operation, concomitant procedures, CPB prime volume, cardiopulmonary bypass and aortic cross-clamp times, use of inotropes (dopamine at a dose of greater than 2 µg · kg^-1 · min^-1, or any other agent) and intraaortic balloon pump, intraoperative complications, total heparin and protamine doses, and highest and lowest activated clotting time; (5) postoperative complications, including 30-day mortality and significant morbidity (defined as reoperation for bleeding, mediastinal infection, pneumonia, respirator use for more than 3 days, transient ischemic attack or cerebrovascular event, myocardial infarction [new Q wave, elevation of creatine kinase-MB level 50 U], low cardiac output [a newly placed intraaortic balloon pump or the use of inotropes for more than 24 hours to maintain a cardiac index greater than 2.0], valve thrombosis, and other major complications [eg, vascular, gastrointestinal]); (6) bleeding and transfusion data, including 24-hour mediastinal chest tube drainage measured from sternal closure, perioperative allogeneic blood transfusion requirement, and volume of blood collected in the cell-saving device; and (7) hematological data, including preoperative, lowest value on bypass, immediate postoperative, and discharge values of hemoglobin, hematocrit, platelet count, international normalized ratio of prothrombin, and partial thromboplastin time.

Statistical Analysis
Statistical analysis was performed by the Department of Biostatistics at the BMC School of Public Health, using the SAS statistical software version 6.11 (SAS Institute, Cary, NC). Data are expressed as mean ± standard deviation. Two-tailed Student’s t test was used to analyze continuous variables. Categoric variables were analyzed using ² with Yate’s correction or Fisher’s exact test when appropriate. A p value of less than 0.05 was considered significant. Multivariate analysis using logistic regression was used to identify factors associated with homologous blood transfusion. For the logistic regression analysis the LOGISTIC procedure was used. A backward-selection method was used to select the variables in the model, with a significance level for entry into the model of 0.1 and a significance level of 0.05 for staying in the model.

	Results

Top Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
Baseline Characteristics
One hundred fourteen patients entered the study and were randomized into FP (n = 57) or RP (n = 57). Ninety-five patients (83.3%) underwent coronary artery bypass grafting. Valve operations with or without coronary artery bypass grafting were performed in 17 patients (14.9%), repair of postinfarction ventricular septal defect in 1 patient, and excision of fibroelastomas of the mitral and tricuspid valves in 1 patient. The baseline characteristics of the study groups are summarized in Table 1. There were no significant differences between the groups with respect to age, sex, functional class, left ventricular ejection fraction, body surface area, and comorbid risk factors.

	Comment

Top Abstract Introduction Patients and Methods Results Comment Acknowledgments References

Efficacy
In this study we demonstrate that further reduction of the crystalloid prime volume by draining it into a cell-saving device before initiation of bypass and replacing it with the patient’s own blood effectively reduced both the incidence and magnitude of allogeneic transfusion. Most of the reduction was related to decreased use of packed red blood cells. In the multivariate logistic regression analysis low prime volume was the only independent predictor of decreased transfusion requirements. In this study clinical outcomes were not significantly different between the groups. This is most likely related to the sample size and overall low incidence of mortality and major complications observed in both groups. However, previous studies have clearly documented a strong correlation between blood transfusion and clinical outcomes, such as mortality, overall morbidity, time to extubation, length of intensive care unit stay, and total hospital stay [2][3].

Mechanism
In our study, confirming previous reports [3][11][12], low preoperative hematocrit was identified as a strong independent predictor of allogeneic blood transfusion. In this study the two groups did not differ with regard to the perioperative hematocrit and coagulation profiles. Postoperative bleeding as reflected by the 24-hour chest tube output was similar between the groups. Also similar were the volumes of crystalloid and scavenged blood used. However, hematocrit values during bypass were significantly lower in the RP group. Thus, most likely, as a result of lesser degree of prime-induced hemodilution in the RP group, fewer allogeneic packed red blood cell units were required to maintain the threshold hematocrit level of 20% during CPB. Similar hematocrit values at discharge between the groups reflect strict adherence to a uniform transfusion protocol, avoiding overtransfusion or undertransfusion in both groups.

Hemodilution and Intravascular Oncotic Pressure
Excessive hemodilution also adversely affects intravascular oncotic pressure, leading to increased extravascular fluid shifts [17]. It has been previously shown that high crystalloid prime volumes are associated with lower oncotic pressures and highly positive fluid balance [18]. Postoperative weight gain (as a measure of fluid shifts) was uniformly low in this study, with no significant difference between the groups. This, however, may be explained in part by the exclusive use of heparin-bonded circuits. Use of more biocompatible surfaces has been previously shown to be associated with attenuated total body inflammatory response [19] and reduced postoperative fluid gain [3][15].

Safety
The two major concerns regarding the routine application of this technique involve (1) the impact of induced hypovolemia on patient’s hemodynamics and organ perfusion and (2) the effect of higher hematocrit values on blood rheology during CPB.

In our study the drainage of the crystalloid prime was performed slowly, carefully avoiding systemic arterial hypotension. Also, use of vasopressors to pharmacologically elevate blood pressure to allow drainage was strictly avoided. Despite these limitations the technique could be uniformly applied. The venous side of the circuit could be drained in all patients, and the arterial side in most. Keeping these precautions, use of vasopressors and inotropic agents was similar between the groups, and the incidence of organ dysfunction (such as low cardiac output or renal failure) was extremely low and similar between the groups.

The rate of oxygen transport is directly related to hematocrit (assuming normal blood cell hemoglobin concentrations and adequate oxygenation) and inversely related to the blood’s apparent viscosity (which is also predominantly determined by hematocrit) [20]. Hypothermia directly increases blood’s apparent viscosity, and also enhances the impact of hematocrit on viscosity. Increased blood viscosity interferes with perfusion of the microcirculation [21]. The inevitable hemodilution associated with crystalloid priming (hematocrit values of 20% to 25%) was found to be rheologically optimal and resulted in low apparent viscosity and shear rates with optimal oxygen transport during hypothermic (25° to 30°C) CPB when metabolic demands are low [22][23][24]. Excessive hemodilution, however, may be deleterious and has been shown to be associated with increased mortality [25]. Recently, near-normothermic (34° to 35°C, avoiding active cooling) has become increasingly popular, and has become a routine in our practice. Under these conditions higher hematocrit values are more desirable to meet increased metabolic demands and are more rheologically appropriate.

Finally, the incorporation of this technique into our overall strategy was certainly cost-effective. There was no added cost because a cell-saving device is used routinely, and there were no technique-related complications. A significant cost saving was achieved by reduction of blood product use.

Conclusion
Lowering CPB prime volume results in a significant decrease in allogeneic blood product use. Because postoperative 24-hour chest tube drainage was similar in both groups, and hematocrit during bypass was higher in the low prime group, the reduction in allogeneic blood transfusions appears to be related to a decrease in prime-induced hemodilution. This technique is effective, simple, and safe. It therefore should be strongly considered in patients undergoing operations using normothermic or near-normothermic CPB who are at high risk for allogeneic transfusions.

	Acknowledgments

Top Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
We thank Timothy Heeren, PhD, from the Boston University School of Public Health for his help with the statistical analysis.

	References

Top Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 

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