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Ann Thorac Surg 1995;60:473-480
© 1995 The Society of Thoracic Surgeons

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Current Reviews

On the Need for Improved Transfusion Indicators in Cardiac Surgery

Departments of Pathology, Medicine, Anesthesiology, and Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, Missouri

	Abstract

Top Footnotes Abstract Introduction Current Transfusion Practices Our Current Understanding of... Should Hemoglobin/Hematocrit Be... The Relationship Between Blood... Point of Care Testing... Summary References

 
Guidelines for transfusion practice have had limited impact in altering physician transfusion behavior in patients undergoing cardiac operations. This may be due to a lack of consensus on the relative risks and benefits of blood in these patients who are anemic, limited access to timely data that are necessary on which to base transfusion decisions, the recognition that empiric hemoglobin/hematocrit thresholds are limited clinical indicators of the need for blood, or a combination of these. We present an overview of current transfusion and blood conservation practices in this setting, along with possible approaches to guide the decision-making process by coupling the use of transfusion algorithms with point of care testing to use more physiologic indicators of the need for blood transfusion.

	Introduction

Top Footnotes Abstract Introduction Current Transfusion Practices Our Current Understanding of... Should Hemoglobin/Hematocrit Be... The Relationship Between Blood... Point of Care Testing... Summary References

 
Medical practice guidelines are being promoted as a means to improve the effectiveness of the health care system. Guidelines for medical practice in general, and transfusion practices in particular, can contribute to improved care only if they change physician transfusion behavior. However, guidelines are unlikely to change behavior unless there are incentives for physicians to do so [1]. Examples of such incentives that have helped make autologous blood procurement a standard of care include (1) patient satisfaction (autologous blood predeposit is popular with patients), (2) physician convenience (the availability of autologous blood makes regional blood inventory shortages less relevant for the elective surgical patient), (3) better patient care (fewer allogeneic blood exposures in autologous blood donors), and (4) lower medical costs (autologous blood procured by acute normovolemic hemodilution is less costly than allogeneic blood purchased from the regional blood center). In the absence of such incentives, there is widespread skepticism about the value of guidelines or recommendations from consensus conferences [1]. One promising approach is to guide the decision-making process by coupling the use of algorithms for the transfusion of blood and blood components with readily-available clinical information obtained from point-of-care testing [2, 3]. We present an overview of published information relevant to transfusion guidelines, along with possible approaches for the cardiac surgical patient that can be used effectively by physicians to improve transfusion outcomes.

	Current Transfusion Practices

Top Footnotes Abstract Introduction Current Transfusion Practices Our Current Understanding of... Should Hemoglobin/Hematocrit Be... The Relationship Between Blood... Point of Care Testing... Summary References

 
Coronary artery bypass grafting (CABG) is one of the most commonly performed operations in the United States, accounting for nearly 10% of the estimated 3.2 million annual recipients of red blood cell transfusions [4]. Although most patients do well after heart operations without apparent complications, follow-up studies of these patients have contributed to our knowledge of transfusion-transmitted diseases such as cytomegalovirus [5] and hepatitis [6], as well as transfusion-related noncardiogenic pulmonary edema [7] and transfusion-associated graft-versus-host disease [8].

Thus, the overall risk-benefit relationship of blood transfusion therapy (ie, the possible benefit of adequate tissue oxygenation at the possible risk of blood-related disease transmission or adverse reactions) has been of particular concern in cardiac surgery because of the nature of the procedure and the large number of blood components transfused. The evolution of CABG has been accompanied by increased application of blood conservation interventions achieved by a combination of blood salvage techniques [9, 10] and acceptance of postoperative normovolemic anemia [11, 12]. Although this trend resulted in a single-institution report of allogeneic red blood cell transfusions in as few as 10% of patients undergoing elective CABG [11], a later report from the same institution indicated an increase in allogeneic blood transfusions to more than 40% of patients largely due to changing patient demographics [13]. Additionally, considerable variation in transfusion practice among institutions has been identified. A recent multicenter audit of 18 institutions has demonstrated a wide range in allogeneic red blood cell (RBC) transfusion requirements for adult patients undergoing simple, first-time CABG with a mean ± standard error of the mean of 2.9 ± 0.1 red cell units for all patients but a range as low as 0.4 ± 0.2 to as high as 6.3 ± 0.6 units for patients from each institution [14]. Follow-up studies of transfusion outcomes in surgical patient populations indicate that a substantial number of blood components in patients undergoing cardiac [15], orthopedic [16], and urologic operations [17] are transfused inappropriately.

Issues of blood safety in transfusion medicine, such as risk of retrovirus transmission in patients undergoing CABG [18], have renewed interest in blood conservation and alternatives to blood transfusion and have resulted in a reassessment of the relative risks and benefits of routinely administered blood and blood components [19]. These developments and practice guidelines have been summarized by the National Institutes of Health consensus conferences on perioperative transfusion of RBC [20], plasma [21], and platelets [22], along with practice guidelines from medical organizations [23, 24]. Yet, as guidelines have suggested hemoglobin thresholds as low as 70 g • L^-1 for transfusion in surgical patients [20], concern has been raised over whether the pendulum has swung too far [25, 26] and that patients who remain untransfused may have clinical complications related to inadequate oxygen delivery [27]. This realization, along with the understanding that hemoglobin is a poor clinical indicator of RBC mass and tissue oxygen delivery [28], has focused attention on the importance of more physiologic clinical transfusion indicators.

	Our Current Understanding of Indicators for Transfusion

Top Footnotes Abstract Introduction Current Transfusion Practices Our Current Understanding of... Should Hemoglobin/Hematocrit Be... The Relationship Between Blood... Point of Care Testing... Summary References

 
A case study [29] of a Jehovah's witness with critical hemodilution has helped define the physiologic threshold in humans at which oxygen consumption starts to decrease because of insufficient oxygen delivery: hemoglobin of 40 g • L^-1, an oxygen extraction ratio of 0.44, a mixed venous oxygen tension of 34 mm Hg, and a mixed venous oxygen saturation of 56%. Yet, Weisel and colleagues [30] found that patients at risk of perioperative ischemic injury show a delay in myocardial metabolic recovery with substantial hemodilution postoperatively to hematocrit levels of 21% to 24%. On the other hand, Lilleaasen [31] reported that hematocrit levels of 18% were as well tolerated as 27% during cardiopulmonary bypass. Robertie and Gravlee [32] concluded that a starting point for hemoglobin levels as clinical indicators for transfusion in CABG patients could be the following:

1. Hemoglobin level of 60 g • L^-1 for well-compensated chronically anemic patients, healthy (American Society of Anesthesiology class I and some class II) patients undergoing intentional hemodilution, and patients undergoing hypothermic cardiopulmonary bypass.
   
2. Hemoglobin level of 80 g • L^-1 for most postoperative CABG patients excepting those with left ventricular hypertrophy, incomplete coronary revascularization, low cardiac output, poorly controlled tachycardia, or sustained fever.
   
3. Hemoglobin level of 10 g • L^-1 for patients unlikely to increase cardiac output, patients with symptomatic cerebrovascular disease, and elderly (age >65 years) patients.
   

Nevertheless, Leone and Spahn [33], as well as others, emphasize that it is unlikely that one hemoglobin number will be universally applicable, so that characterization of the effects of hemodilution and anemia on the cardiovascular system (ie, physiologic changes) is crucial to our ability to use both allogeneic and artificial blood therapy effectively.

	Should Hemoglobin/Hematocrit Be Supplemented With a More Physiologic Indicator?

Top Footnotes Abstract Introduction Current Transfusion Practices Our Current Understanding of... Should Hemoglobin/Hematocrit Be... The Relationship Between Blood... Point of Care Testing... Summary References

 
In a recent study of critically ill patients with sepsis, Yu and colleagues [34] evaluated a set of physiologic goals to optimize oxygen delivery (>600 mL • min^-1 • m^-2), cardiac index (4.5 L • min^-1 • m^-2), and oxygen consumption (170 mL • min^-1 • m^-2) with a series of interventions including fluid boluses, administration of blood products, and the use of inotropes. They found that the intervention group had fewer complications, a lower number of days on the ventilator and in intensive care, and lower hospital charges compared with a standard therapy group. This study illustrates the paradigm that interventions keyed to patient-specific physiologic clinical indicators can result in better clinical outcomes.

When hemoglobin concentration is reduced, compensatory mechanisms to maintain oxygen delivery (eg, cardiac output increase) can be variable. Physiologic indicators of the adequacy of oxygen delivery have been proposed, either as directly measured or as calculated variables. The two general categories for these variables are hemodynamics and oxygenation. The routine placement of thermodilution pulmonary artery and arterial catheters in CABG patients enables regular assessment of mixed venous oxygen saturation (SVO₂), along with hemodynamic variables such as cardiac index, heart rate, cardiac filling pressures, and systemic and pulmonary blood pressures.

The SVO₂ is an indicator of the relative balance between the total body oxygen supply and demand. As a sensitive but nonspecific indicator, SVO₂ represents a weighted balance from all perfused vascular beds. When arterial oxygen saturation is adequate (>0.90), the SVO₂ inversely reflects the oxygen supply-demand balance [35]. Published reports have demonstrated that SVO₂ provides continuous quantification of global oxygen extraction [36], in which a mixed venous oxygen tension greater than 40 mm Hg (SVO₂ approximately 75%) is believed to indicate adequate tissue oxygenation in most clinical states, and a mixed venous oxygen tension less than 20 mm Hg (SVO₂ approximately 30%) suggests inadequate tissue oxygenation [37].

In addition to clinical indicators for hypovolemia and RBC transfusion (eg, tachycardia, hypotension, oliguria), physiologic indicators of clinically significant impairment of the oxygen supply-demanded balance include SVO₂ less than 0.60, mixed venous oxygen tension less than 30 mm Hg, or both. That is, when the hemoglobin level falls below ``acceptable'' values, these indicators indicate a potential benefit from transfusion. However, the precise ``acceptable'' hemoglobin concentration range is unknown. It is generally accepted that RBC transfusion to improve oxygen transport when the hemoglobin level is greater than 140 g • L^-1 is almost never of benefit. The National Institutes of Health consensus conference concluded that most patients with hemoglobin levels greater than 100 g • L^-1 do not require blood, whereas most patients with hemoglobin levels less than 70 g • L^-1 benefit from blood [20]. Clinical experience, but not scientific data, suggests that oxygen transport balance usually improves with transfusion when the hemoglobin level is 70 to 100 g • L^-1. Silent perioperative ischemia has been identified as a significant clinical problem in noncardiac [38] and cardiac [39] surgical patients, underscoring the fact that the heart is an important organ at risk with regard to tissue oxygenation. A recent case report [40] illustrated silent myocardial ischemia in a surgical patient whose hematocrit level of 27% was corrected with the transfusion of two RBC units. Hemoglobin levels from 70 to 100 g • L^-1, a range in which physiologic indicators may identify patients who can benefit (or not benefit) from blood, therefore need to be the most closely scrutinized.

A number of studies in patients undergoing CABG have been conducted to seek to understand prevailing transfusion practices, along with the determinants of transfusion practices and of transfusion outcomes in this setting. Historically, these determinants have included preoperative hemoglobin level, initial RBC volume, female gender, and blood loss [11]. More recent studies, however, have demonstrated that the substantial variation in transfusion outcomes among institutions is explained, in part, by differences in physician transfusion behavior [14]. This may be due to different anesthesiologist and surgeon transfusion decision-makers [41], lack of consensus regarding the appropriate transfusion trigger for hemoglobin [19], or the inherent limitations of the nadir hemoglobin level as a clinical indicator for RBC transfusion [42]. Currently transfusion decisions are made on the basis of empiric combinations of estimation of blood losses, the hemoglobin/hematocrit level, and clinical assessment of the patient. Recent studies have demonstrated that this approach may greatly overestimate the need for RBC transfusion; 112 (22%) of 498 patients undergoing CABG in a national study were identified to have been transfused with blood inappropriately (Table 1) [15]. Although 21 of these 112 patients had admission hematocrit levels of 30% or less, suggesting that RBC transfusions evaluated even by a ``generous'' clinical indicator may have been appropriate in this subgroup, 60 of these 112 patients were transfused with RBC volumes that exceeded the actual RBC losses.

	The Relationship Between Blood Conservation and Blood Transfusion

Top Footnotes Abstract Introduction Current Transfusion Practices Our Current Understanding of... Should Hemoglobin/Hematocrit Be... The Relationship Between Blood... Point of Care Testing... Summary References

Preoperative autologous blood procurement has been identified as a standard of care for elective operations [20, 23], especially for patients who undergo orthopedic and radical prostatectomy procedures [48, 49]. Yet, only 42 (7.7%) of 540 CABG patients followed up for transfusion outcomes at 18 institutions had autologous blood available either by preadmission donation or by acute normovolemic hemodilution [14]. Furthermore, preoperative autologous blood donation has been demonstrated to be poorly cost-effective [50]. Decision analysis has estimated that approximately 101,000 cardiac surgical patients would need to predonate autologous blood safely to save the life of 1 patient who would otherwise die of complications related to an allogeneic blood transfusion [50].

There is no good evidence, or even general agreement, that preoperative autologous blood donation can be accomplished in 101,000 patients safely and without mortality before cardiac operations. In a review of 886 donations in a nonhospital setting by donors not meeting the criteria for allogeneic blood donation (mostly because of their cardiac history) 4.3% of donations were accompanied by reactions [51], of which 4 (0.4%) were severe (1 transient ischemic attack and 3 angina episodes). In two smaller hospital-based series, 1 (1%) of 107 cardiac patients and 1 (1.2%) of 79 cardiac patients had severe reactions requiring hospitalization [52, 53]. In a recent study of 24 patients scheduled for cardiac operations, Holter monitoring during blood donation demonstrated a significant increase in the duration and intensity of myocardial ischemic events after blood donation [54]. Thus, serious morbid events have been documented to occur during preoperative autologous blood donation in patients at risk. In addition, there is a defined rate of mortality in cardiac patients who await operation. In a recent series of patients reported from the Netherlands, 25 (2.2%) of 1,124 consecutive patients scheduled for CABG died before operation [55]. Two hundred eighty-eight of these patients were on a ``medium priority'' list with a mean waiting period of 39 days (which approximates the storage interval for donated blood); 2 (0.7%) of these patients died before operation. In an ``intention to treat'' analysis, any mortality due to progression of cardiac disease during the interval required for autologous blood donation must be considered a complication of preoperative autologous blood donation.

Despite published guidelines [23] and consensus conference recommendations [20] that acute preoperative normovolemic hemodilution can be a method of autologous blood procurement, the value of this technique has been poorly defined. A case study analysis in patients undergoing radical prostatectomy demonstrated that in this absence of a defined protocol this procedure has limited efficacy [56]. Subsequently a prospective acute preoperative normovolemic hemodilution protocol in which 2,000 mL (4 units) of hemodilution was performed to lower the patients' presurgical hematocrit level to 28%, followed by retransfusion to maintain perioperative hematocrit greater than 25%, was analyzed for 30 consecutive patients with a matched cohort of 30 patients who had predeposited three autologous blood units, and found no difference in subsequent allogeneic outcomes: 3 (10%) of 30 patients in each cohort received allogeneic blood. Thus, moderate hemodilution may be an equally effective and less costly alternative to preoperative autologous blood donation as a blood conservation strategy [57], particularly when performed with a defined clinical indicator for blood transfusion.

A similar technique known as ``blood pooling'' has been described in cardiac surgery. The removal of 2 autologous blood units at the onset of cardiopulmonary prime has been shown in a recent report to reduce subsequent allogeneic blood requirements [58]. However, the perceived advantages [59] of fresh whole blood procured by this technique have been outweighed by uncertainties: (1) regarding its implementation in the large number of patients presenting for operation who are already anemic and (2) regarding the intraoperative clinical transfusion indicator for the retransfusion of this blood in patients who already undergo substantial hemodilution related to the crystalloid/colloid pump prime.

These studies demonstrate the importance of better-defined transfusion triggers to complement the blood conservation practices that have evolved in cardiac surgery [60]. Previous studies have found that although the RBC needs of these patients are substantial, if a combination of conservative transfusion practice and blood conservation provided the equivalent of 4 blood units, then up to 75% of CABG patients could avoid allogeneic blood exposure [15]. Because 80% of RBC transfusions are received on the day of operation and 90% by the end of the first postoperative day [15], the effectiveness of interventions focused on these 2 days would be substantial. Although blood loss estimates do correlate with blood transfusions [15], the correlation is poor at lower blood loss estimates, perhaps explaining why patients may be transfused in excess of their needs, when decisions to transfuse are made on a clinical indicator (blood loss) that is poorly quantifiable [41]. Finally, patients are heterogeneous with respect to perhaps the primary determinant of need for RBC transfusion, the presurgical hemoglobin/hematocrit level [9]. The distribution of admission hematocrit levels is especially broad for cardiac surgery patients identified to have been transfused inappropriately [15]. Thus, transfusion algorithms can be especially useful if they incorporate point of care information that is both physiologic and patient-specific for transfusion decisions.

	Point of Care Testing and Transfusion Algorithms

Top Footnotes Abstract Introduction Current Transfusion Practices Our Current Understanding of... Should Hemoglobin/Hematocrit Be... The Relationship Between Blood... Point of Care Testing... Summary References

 
Plasma and Platelet Therapy
Although the discharge hematocrit level is useful in a retrospective understanding of transfusion outcomes [42], transfusion guidelines using concurrent clinical indicators are necessary if physician transfusion behavior is to be altered. Studies have been conducted to evaluate the impact of point-of-care testing [3, 61], in which intraoperative assays (on-site evaluation of whole blood prothrombin time, activated partial thromboplastin time, and platelet count with results available within 4 minutes) were linked with a transfusion algorithm for plasma and platelet transfusions in cardiac surgical patients determined to have microvascular bleeding after heparin neutralization (Fig 1).

View larger version (29K): [in this window] [in a new window]   Fig 1. . An algorithm approach for hemostatic therapy in cardiac patients determined to have microvascular bleeding after heparin neutralization (FFP = plasma therapy [2 units of fresh-frozen plasma]; [+] MVB = continued microvascular bleeding; Platelets = platelet transfusion [6 units of random-donor or apheresis unit equivalent]; PLT RX = platelet therapy [platelet transfusion, desmopressin acetate therapy, or both at physician's discretion]; PLT count = platelet count [x103/µL]; PT:APTT = whole blood prothrombin time and activated partial thromboplastin time control values [values/mean values from a normal reference population]). (Reprinted with permission from Despotis GJ, Santoro SA, Spitznagel E, et al. Prospective evaluation and clinical utility of on-site monitoring of coagulation in patients undergoing cardiac operation. J Thorac Cardiovasc Surg 1994;107:271–9.)

Finally, an analysis of the relationship between RBC volumes lost during hospitalization with the units of RBC, total non-RBC, and total blood components transfused indicated that the algorithm was successful in altering physicians' transfusion practices. The slope of this relationship was significantly greater for the standard therapy group, indicating that for any given amount of RBC lost, the algorithm group received fewer blood component transfusions compared with the standard therapy group. This approach has been described as a ``powerful engine of change'' [2]. The improved patient care along with reduced blood transfusions resulted in substantial economic savings [62].

In the post-cardiopulmonary bypass setting, a prompt assessment of coagulation allows targeted therapy for acquired platelet function defects. In a recent randomized, prospective trial, a thromboelastograph-based measurement identified patients at risk for excessive postoperative microvascular bleeding who might respond to desmopressin acetate therapy [63]. Patients with an abnormal (<50 mm) thromboelastographic maximum amplitude measurement had significantly greater mediastinal chest tube drainage when compared with those with a normal maximum amplitude value; in contrast, matched patients with an abnormal maximum amplitude who were treated with desmopressin acetate had similar blood losses when compared with those with a normal maximum amplitude value. In a follow-up trial at the same institution, use of thromboelastograph-directed desmopressin acetate therapy in patients at high risk for bleeding also resulted in reduced blood product use in the intervention cohort. The thromboelastograph also may identify patients who have excessive post-cardiopulmonary bypass fibrinolysis and who may respond to -aminocaproic acid administration. One limitation of this assay is its 20 to 30 minute response time. Although other assays that evaluate qualitative platelet abnormalities by means of clot retraction method have been developed, controlled trials using these methods currently are lacking. Ultimately, these types of assays may enhance our ability to assess qualitative defects in hemostasis that may respond to pharmacologic therapy.

The recent approval of the antifibrinolytic agent aprotinin for the prophylaxis of microvascular bleeding represents an alternative approach. Although studies have demonstrated its effectiveness in lowering perioperative bleeding and blood transfusion requirements, increased thromboembolic complications have been observed when heparin administration was based on celite activated coagulation time protocols [64]. Monitoring coagulation in the perioperative period exclusively with the activated coagulation time may be misleading because previous studies have illustrated that activated coagulation time values do not correlate well with plasma heparin measurements during extracorporeal circulation. Additionally, patients also receive lower heparin doses when their heparin dosing schedule is guided by celite activated coagulation time protocols in the setting of concurrent aprotinin administration. Stable heparin levels can be maintained during cardiopulmonary bypass using heparin concentration assays as an alternate method of point-of-care testing. These have been shown to correlate with anti-Xa laboratory heparin measurements in patients receiving aprotinin [65]. In a recent multicenter trial the incidence of thrombotic complications was not increased in aprotinin-treated patients who received heparin based on heparin concentration measurements [66].

Red Blood Cell Therapy
Decisions to transfuse blood products in surgical patients must acknowledge that patients are heterogeneous for morbidity and mortality risks related to anemia. One prospective approach to risk stratification for cardiac surgical patients has been published recently [67]. As detailed in Table 2, fourteen clinical variables account for whether a patient is considered as a ``standard'' or an ``increased'' risk for cardiac operation. Although complications related to anemia represent only one arena of morbidity/mortality in this setting, the physiologic changes known to accompany acute anemia [68], the potential for myocardial tissue injury [40], and the implications for transfusion management suggest that risk stratification for RBC transfusion decisions is prudent. Presented below is an approach for the use of clinical indicators for RBC transfusion that is intended to help (1) standardize transfusion practices and (2) improve transfusion practices in the cardiac surgical patient.

POSTOPERATIVE MANAGEMENT.
With the recognition that transfusion support is dependent on both rate of blood loss as well as hemoglobin level, the decision to transfuse each unit of RBC should be based on both known hemoglobin level and the quantity (rate) of blood lost. Each patient should be treated to achieve adequate pulmonary capillary wedge pressures and filling pressures with crystalloid/colloid therapy before entering a transfusion algorithm (Fig 2).

View larger version (18K): [in this window] [in a new window]   Fig 2. . An algorithm approach for red blood cell (RBC) transfusion in cardiac surgical patients postoperatively. After establishing that the patient's volume status is adequate, decisions to transfuse would be based on hemoglobin/hematocrit (Hct) level, rate of blood loss, and hemodynamic parameters. Thresholds for transfusion would differ for patients determined to be at ``low'' risk and ``high'' risk for perisurgical complications. (CI = cardiac index; MAP = mean arterial pressure; PRBC = packed red blood cells; Rx = treatment; SVO2 = venous oxygen saturation.)

Alternatively, an algorithm that incouples decisions regarding RBC transfusion to changes in SVO₂ within a range of hematocrit level would couple the relationship between oxygen delivery and oxygen consumption with RBC transfusion therapy (Fig 3).

View larger version (24K): [in this window] [in a new window]   Fig 3. . An algorithm approach for red blood cell transfusion. Same as Figure 2, with the addition of mixed venous oxygen percent saturation (SVO2) as a physiologic indicator of the balance between oxygen supply and demand for transfusion decision-making. (Abbreviations as in Figure 2.)

	Summary

Top Footnotes Abstract Introduction Current Transfusion Practices Our Current Understanding of... Should Hemoglobin/Hematocrit Be... The Relationship Between Blood... Point of Care Testing... Summary References

	Footnotes

Top Footnotes Abstract Introduction Current Transfusion Practices Our Current Understanding of... Should Hemoglobin/Hematocrit Be... The Relationship Between Blood... Point of Care Testing... Summary References

 
Address reprint requests to Dr Goodnough, Washington University School of Medicine, Box 8118, 660 S Euclid Ave, St. Louis, MO 63110.

	References

Top Footnotes Abstract Introduction Current Transfusion Practices Our Current Understanding of... Should Hemoglobin/Hematocrit Be... The Relationship Between Blood... Point of Care Testing... Summary References

 

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