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Vol 10, No 6, November/December 2002 393 The safety of surgical blood man- agement practices is critically important because of the potential risks of transfusion reactions, im- munosuppression, and disease transmission associated with use of allogenic blood. One response to these concerns has been increased use of autologous blood. Approxi- mately 15 years ago, less than 5% of patients participated in preopera- tive autologous donation (PAD) before elective surgery. 1 Today, 50% to 75% of patients opt for PAD, primarily because of concerns about transfusion-transmitted human im- munodeficiency virus (HIV) and hepatitis. Other blood management techniques have been developed, including the use of hemostatic agents, perioperative blood salvage, and the use of recombinant human erythropoietin (epoetin alfa) to stim- ulate erythropoiesis. Because of the implications for the effective man- agement and allocation of blood bank resources, making the opti- mum choice requires careful preop- erative decision making. Proper preoperative planning also can opti- mize the patient’s perioperative course and recovery. Predictors of Transfusion Risk A patient’s risk of requiring a trans- fusion during surgery and in the immediate postoperative period is an important element of effective blood management. Estimated peri- operative blood loss and preopera- tive hemoglobin (Hb) concentration are critical predictors of the need for blood transfusion. 2,3 Cohen and Brecher 4 developed a nomogram to estimate the volume of surgical blood loss that would trigger a deci- sion to transfuse, based on the patient’s preoperative and mini- mum tolerable postoperative hemat- ocrit (Hct) levels. Preoperative Hb concentration itself is readily assess- able and statistically is a powerful predictor of the risk of requiring a transfusion. 5 In a study of 9,482 patients who underwent total hip or knee arthroplasty, Bierbaum et al 6 demonstrated that the lower the baseline Hb level, the more proba- ble the transfusion of allogenic blood. Of the 3,020 patients who met the study entry requirement of baseline Hb >10 but ≤13 g/dL, 864 (29%) needed a transfusion of allo- genic blood compared with 267 (8%) of 3,374 patients with baseline Hb >14 g/dL. Other studies have Dr. Keating is Orthopaedic Surgeon, The Center for Hip and Knee Surgery, Mooresville, IN. Dr. Meding is Orthopaedic Surgeon, The Center for Hip and Knee Surgery, Mooresville. One or more of the authors or the departments with which they are affiliated has received something of value from a commercial or other party related directly or indirectly to the sub- ject of this article. Reprint requests: Dr. Keating, 1199 Hadley Road, Mooresville, IN 46158. Copyright 2002 by the American Academy of Orthopaedic Surgeons. Abstract Concern about the cost and safety of allogenic blood transfusion, including the risk of viral infection and immunosuppression, has led to refinements in and new approaches to blood conservation, including the development of transfusion practice standards and improvements in surgical practice. Preoperative autolo- gous blood collection, the use of hemostatic agents, perioperative blood salvage, and the use of recombinant human erythropoietin (epoetin alfa) to stimulate erythropoiesis have contributed to decreased use of allogenic blood services. Development of appropriate blood management strategies to help reduce or eliminate exposure to allogenic blood requires a preoperative assessment of the likelihood of transfusion and of the risks as well as costs associated with conser- vation and replacement options. The informed selection of alternatives based on preoperative assessment of hematologic status, estimated blood loss, and sources for blood replacement may enhance blood management practices in major elec- tive orthopaedic surgery. J Am Acad Orthop Surg 2002;10:393-400 Perioperative Blood Management Practices in Elective Orthopaedic Surgery E. Michael Keating, MD, and John B. Meding, MD shown that surgical morbidity and mortality are inversely correlated with preoperative Hb levels. 3,7 Although the transfusion thresh- old of Hb 10 g/dL and Hct 30% (the 10/30 rule) is no longer common practice, using lower transfusion thresholds has not resulted in deter- mination of an optimal threshold for all patients. 8 Instead, the deci- sion for blood transfusion should be based on a patient’s overall clinical status and the nature of the anemia (eg, acute or chronic) once other measures of red blood cell repletion have failed. 9,10 Effect of Anemia on Surgical Outcomes The primary purpose of transfusion is to reduce the risks associated with anemia, which is common in pa- tients undergoing elective ortho- paedic surgery. Of the 8,561 pa- tients in the Bierbaum study 6 for whom the baseline Hb level was known, 35% (3,020) had a level ≤13 g/dL. Furthermore, the mean Hb level decreased from a mean base- line value of 13.8 to 12.8 g/dL before admission in patients who predonat- ed blood. In another study 11 assess- ing the prevalence of anemia in elec- tive orthopaedic surgery patients, 34 (21%) of 162 patients who predonat- ed autologous blood were anemic (Hct ≤39%) at initial donation. Sub- sequently, 35% of these anemic donors required allogenic blood transfusion, indicating a need for early identification and treatment of anemia. Furthermore, the incidence of anemia by numeric criteria in elderly patients (≥65 years) is four to six times greater than can be predict- ed by the presence of clinical symp- toms. 12 The incidence of anemia increases with age 12 and is of partic- ular concern because the elderly constitute a large proportion of pa- tients undergoing elective ortho- paedic surgery. Morbidity and Mortality Anemia has an adverse effect on morbidity and mortality. Morbidi- ties associated with both acute and chronic severe anemia (Hb <6 g/dL), especially in older patients, include fatigue, tachycardia, hypotension, dyspnea, and impaired levels of consciousness. 13,14 Anemia and the associated need for transfusion also can lengthen the duration of hospi- talization after elective orthopaedic surgery. In the Bierbaum study, 6 patients who received a transfusion of only allogenic blood had the longest mean duration of hospital- ization (6.6 days), compared with patients who were transfused with autologous blood (5.6 days) or had no transfusion (5.4 days) (P ≤ 0.01). Severe preoperative anemia is associated with an increased risk of postoperative mortality. Carson et al 8 reported that the 30-day mortality rate in cardiovascular patients with preoperative Hb levels <6 g/dL was 33.3% compared with 1.3% for those with levels ≥12 g/dL. (The patients with low Hb levels refused transfu- sion because of religious convic- tions.) In an earlier study, 7 a higher surgical mortality rate was reported for patients with Hb levels <6 g/dL (61.5%) compared with those with levels >10 g/dL (7.1%). Patient Vigor and Quality of Life Another potential complication of anemia is decreased vigor, which can have implications for recovery, prolonging length of hospitalization and affecting quality of life. Early inpatient rehabilitation after surgery decreases the length and cost of hospitalization and enhances short- term functional recovery. 15 Assess- ments of the patient’s preoperative and postoperative vigor could, therefore, play an important role in initiating and monitoring the early rehabilitation program. A correlation (r = 0.4) between muscle strength (a surrogate mea- sure of vigor) and Hct levels sug- gests that Hct may be a valuable objective measure of vigor in pa- tients undergoing major elective or- thopaedic surgery. 16 Furthermore, improving vigor in this population by increasing Hb and Hct levels could facilitate recovery and im- prove overall quality of life. Studies assessing the effect of increases in Hb on quality of life after adminis- tration of epoetin alfa in anemic cancer patients demonstrated a direct correlation between Hb level and quality of life. 17,18 The largest improvement in quality of life in these patients occurred when Hb levels were increased from 11 to 12 g/dL. 17 However, a similar correla- tion between increases in Hb and improved quality of life in ortho- paedic surgery patients remains to be established. Perioperative Blood Management Allogenic Blood Transfusion Historically, allogenic blood transfusion has been the mainstay in perioperative blood manage- ment. However, the association of allogenic blood transfusions with numerous risks—including trans- mission of HIV, hepatitis B and C viruses, and human T-cell lym- photropic virus types I and II—has diminished its utility 19,20 (Table 1). The institution of various measures to improve the detection and elimi- nation of tainted blood supplies has substantially reduced the estimated risks of transfusion-transmitted dis- eases. 21 The implementation of HIV- antibody testing in 1985 reduced the rate of transfusion-associated HIV infection reported to the Centers for Disease Control and Prevention from 714 cases in 1984 to only about 5 cases per year during the subse- quent 5 years. 21 Similarly, screening tests for hepatitis B and C viruses also have decreased the number of cases of posttransfusion hepatitis. 21 Blood Management in Elective Orthopaedic Surgery Journal of the American Academy of Orthopaedic Surgeons 394 Nevertheless, the risk of infection or other adverse reactions still exists. Observational retrospective reports 22 and prospective studies 23 both have described an association between exposure to allogenic blood and increased rates of postop- erative infection and early recur- rence of cancer. Although exposure to leukocytes in allogenic blood and subsequent sensitization can trigger an immunosuppressive reaction, the clinical importance of this immuno- suppression has yet to be clearly defined. 21 Other risks include bac- terial contamination and transfu- sion-related acute lung injury. Finally, despite advances in the understanding of red blood cell antigens, allogenic transfusions are known to cause fatal acute hemolytic reaction (albeit rarely). Directed donation of allogenic blood increased in the early 1990s, presumably because the practice allayed the fears of some patients of contracting disease from unknown donors. Nevertheless, directed donations accounted for only 2% to 3% of all blood collected between 1989 and 1994 in the United States and have since declined. 1 Although the use of blood from directed do- nations potentially can accelerate surgery compared with the time required for donation of autologous blood or for epoetin alfa therapy, no evidence suggests that directed donations lessen the risks associated with allogenic blood transfusion. Preoperative Autologous Blood Donation The use of PAD has increased sub- stantially in recent years although it has been associated with such risks as preoperative anemia, ischemic events, and complications severe enough to require hospitalization. 24-27 Furthermore, the magnitude and rate of patient response to compensatory erythropoiesis to replace donated red blood cells generally has been overes- timated. 1 In one study, 27 preopera- tive donation between 42 and 7 days before surgery still resulted in an average decrease of 1 g/dL for every unit of autologous blood donated, suggesting an absence of adequate compensatory erythropoiesis. Au- thors of a recent study of 225 adults estimated that compensatory eryth- ropoiesis resulted in preoperative mean red blood cell production of 351 mL compared with a mean loss of 522 mL from weekly donations of autologous blood. 28 In another study of patients undergoing aggressive autologous blood phlebotomy, the administration of erythropoietin increased preoperative red blood cell production from 568 mL (placebo group) to 911 mL. 29 Adequate iron supplementation is important for patients with low iron stores while they undergo erythropoietin treat- ment. 30 The degree of compensatory erythropoiesis depends on initial iron status but not on patient age and sex. 31 Overcollection of blood also is a problem associated with PAD. As much as 50% of autologous blood is unused in patients undergoing joint replacement or radical prostatec- tomy. 1 PAD is often used to cover the need for a range (up to 90%) of patients who might need blood, a practice that results in the routine collection of more blood than is needed for the average patient. (Some patients who have blood col- lected do not require it; other pa- tients have more blood collected than is needed.) Other reasons for the possible overuse of PAD include perceptions that PAD is associated with no or few adverse events, pa- tients’ fears of contracting transfu- sion-transmitted diseases, and po- tential legal issues associated with allogenic blood transfusions. In addition to weighing the risks of anemia and the cost of medical resources associated with overcollec- tion, clinicians considering PAD for elective surgeries should review published guidelines for the appro- E. Michael Keating, MD, and John B. Meding, MD Vol 10, No 6, November/December 2002 395 Table 1 Estimated Risks of Allogenic Blood Transfusion 19,20,22,23 Risk Frequency of Occurrence per Unit of Blood Transfused Viral infection HIV 1:1,000,000 HBV 1:100,000 HCV 1:500 to 1:5,000 HTLV I and II 1:200,000 CMV and bacterial contamination Varies; 1:2,500 Immunosuppression Infection Increased after surgery Cancer Inconclusive Transfusion reaction Fatal hemolytic reaction <1:600,000 Nonfatal hemolytic reaction 1:6,000 Fever or urticaria 1:100 Allergic reaction 1:100 Graft-versus-host disease Rare Alloimmunization Common HIV = human immunodeficiency virus; HBV = hepatitis B virus; HCV = hepatitis C virus; HTLV = human T-cell lymphotropic virus; CMV = cytomegalovirus. priate use of PAD. 32 Patients should be stratified according to risk of requiring a transfusion. This stratifi- cation is based on preoperative Hb levels and the estimated blood loss associated with the scheduled proce- dure. As mentioned, preoperative Hb levels are a practical means of estimating the risk of requiring a transfusion. 5 However, algorithms that determine low and high risk for transfusion based on estimated blood loss and preoperative Hct level may have limited usefulness because of the difficulty in predict- ing actual blood loss for a given pro- cedure and patient. According to the British consensus guidelines, 32 PAD should be considered only if the likelihood of transfusion exceeds 50%. In the United States, this per- centage is much lower because laws in some states require that the possi- bility of autologous transfusion be presented to patients even though the likelihood of transfusion is low. Patients being considered for PAD should receive supplemental oral iron therapy (eg, 325 mg ferrous sul- fate 3 times a day). Autologous blood donation generally should begin 3 to 5 weeks before the sched- uled surgery. PAD allows patients to fulfill blood requirements for planned sur- gical procedures with minimal risk of transfusion-transmitted diseases. Predominantly the risk is that of clerical error, similar to that of allo- genic transfusion. In addition, PAD is sometimes wasteful and should be used only in the context of care- ful preoperative planning. Acute Normovolemic Hemodilution Acute normovolemic hemodilu- tion (ANH) involves simultaneous removal of whole blood from a patient immediately before begin- ning surgery and replacement with acellular fluids, such as crystalloid and colloid, to maintain normovol- emia. 1 The blood is collected in an anticoagulant-containing bag and stored in the operating room, to be reinfused after any major loss of blood. Guidelines for ANH recom- mend that this approach be consid- ered when the potential surgical blood loss is likely to exceed 20% of blood volume in patients with a preoperative Hb level >10 g/dL. 1 In contrast with PAD, ANH does not require testing to screen for transfusion-transmitted viral dis- eases and therefore is less costly. Furthermore, there is virtually no risk of bacterial contamination or of an administrative error that could lead to an ABO-incompatible blood transfusion. ANH also does not require the additional investment of time from patients to donate blood before surgery, nor does it prolong the duration of surgery and anes- thesia. 33 However, ANH is con- traindicated in patients with coro- nary artery, renal, pulmonary, or severe hepatic disease. 10 Also, because the precision required to implement the technique is time consuming, the use of ANH is often impractical in many orthopaedic procedures of short duration. 10 Epoetin Alfa The main regulator for erythro- poiesis is erythropoietin, a glycopro- tein hormone synthesized predomi- nantly in the kidney and secreted by renal cortical interstitial cells in response to tissue hypoxia. Erythro- poietin functions in the recruitment and differentiation of erythroid progenitor cells, aids in their mainte- nance and survival, and stimulates the synthesis of Hb. Epoetin alfa is identical to endogenous erythropoi- etin in its amino acid sequence and biologic activity. Like endogenous erythropoietin, epoetin alfa effec- tively and safely stimulates synthe- sis of Hb and thus has clinical value in the treatment of anemia. Epoetin alfa has been available for more than 10 years and has been used to treat anemia in patients with chronic renal failure, in patients with non- myeloid malignancies (in which anemia results from concomitantly administered chemotherapy), and in HIV-infected patients with anemia related to treatment with zidovu- dine. Epoetin alfa also has been used preoperatively in patients undergoing elective noncardiac, nonvascular surgery. Research is ongoing in other patient popula- tions, including critical care patients. Although epoetin alfa can be administered both intravenously and subcutaneously, subcutaneous administration generally is pre- ferred because slow release from subcutaneous depots provides more sustained plasma levels. 34 For sur- gical patients, these sustained plas- ma levels allow for weekly dosing of epoetin alfa. Adequate iron sta- tus must be maintained through supplementation in patients receiv- ing epoetin alfa. 35 Epoetin alfa is useful in the peri- operative treatment of anemia in patients undergoing elective, non- cardiac, nonvascular surgery. 36 Studies in anemic (Hb ≥10 to ≤13 g/dL) patients undergoing elective orthopaedic surgery have shown that treatment with epoetin alfa (300 IU/kg/day for 15 days periopera- tively, or 600 IU/kg in four weekly doses beginning 3 weeks before surgery) increases preoperative Hb concentrations and reduces the need for perioperative allogenic blood transfusions. 37-40 Figure 1 is a treat- ment algorithm for the use of epoetin alfa in anemic patients. Normal pa- tients with Hb <10 g/dL should be worked up by a hematologist. Pa- tients with a chronic disease such as rheumatoid arthritis and Hb <10 g/dL should receive epoetin alfa for a longer duration. No significant safety issues have been noted in studies of epoetin alfa in surgical patients. Incidence of thrombotic/vascular events, blood pressure changes, pain, bruising, and stinging at the injection site did Blood Management in Elective Orthopaedic Surgery Journal of the American Academy of Orthopaedic Surgeons 396 not differ significantly from those of placebo groups. 37,38 Intraoperative Blood Management Optimal intraoperative blood man- agement reduces the need for allo- genic blood transfusion through modifications in surgical technique, use of hemostatic agents, and blood salvage strategies. Approximately two thirds of transfusions in the United States are related to surgical procedures; 10 orthopaedic surgeons, therefore, should be aware of the blood conservation strategies as well as the relevant pharmaceutical agents available (Fig. 2). Surgical Technique Blood loss can be minimized through careful adherence to pre- scribed guidelines for maintaining hemostasis. 41 Techniques such as electrocautery and argon-beam coagulation can reduce blood loss safely and effectively. Hypotensive anesthesia is an effective option for blood management for procedures such as spine surgery and arthro- plasty. In patients undergoing pri- mary total hip arthroplasty, a differ- ence in mean arterial blood pressure of 10 mm Hg (from 60 to 50 mm Hg) significantly (P = 0.004) reduced mean intraoperative blood loss from 263 to 179 mL. 42 In addition, an arterial line is necessary for this technique. Hemostatic Agents Pharmacologic agents available or under investigation for mainte- nance of perioperative hemostasis include topically active agents and antifibrinolytics. 10 Topically or locally active agents include throm- bin, collagen, and fibrin glue. A proprietary gelatin matrix contain- ing thrombin was shown to stop bleeding in cardiac surgery within 10 minutes in 94% of patients. 43 Collagen-based topical hemostatic agents also controlled bleeding. Fibrin glue, made with highly con- centrated human fibrinogen and clotting factors, does not depend on platelet or clotting factor levels to be effective. The use of a fibrin tissue adhesive significantly (P < 0.001) reduced mean postoperative blood loss from 878 to 360 mL in a study of 58 patients undergoing total knee arthroplasty. 44 The fibrin tissue adhesive was sprayed on the inter- nal aspects of the operating field before skin closure. Although the use of antifibri- nolytic drugs to maintain periopera- tive hemostasis has increased, they remain controversial because of high cost and the risk of thromboembolic complications. 45 Desmopressin has been widely used to prevent bleed- ing in other types of surgery, 46 but several studies have shown that it failed to decrease blood loss or E. Michael Keating, MD, and John B. Meding, MD Vol 10, No 6, November/December 2002 397 Pretreatment Hb ≤10 or >13 g/dL>10 to ≤13 g/dL Not a candidate for epoetin alfa therapy If the preoperative period is <3 wk, treat with epoetin alfa 20,000 U* (300 U/kg) 10 d preoperatively, on the day of surgery, and 4 d postoperatively If the preoperative period is ≥3 wk, treat with epoetin alfa 40,000 U* (600 U/kg) on days −21, −14, and −7, and the day of surgery Figure 1 Treatment algorithm for use of epoetin alfa in anemic patients scheduled for elective, noncardiac, nonvascular sur- gery at high risk for transfusion because of anticipated blood loss. * Based on patient weight of 70 kg. Decision for orthopaedic surgery Measure Hb >10 to ≤13 g/dL* Predict Hb drop Transfusion risk <10% Transfusion risk ≥10% Surgery Surgery Surgery Surgery Donate autologous blood Treat anemia with oral iron supplementation and epoetin alfa Transfusion risk <10% Transfusion risk ≥10% >13 g/dL Predict Hb drop Figure 2 Algorithm for optimizing blood management strategies in orthopaedic surgery. Average Hb drop: single total knee replacement, 3.85 ± 1.4 g/dL; bilateral total knee replacement, 5.42 ± 1.8 g/dL; single total hip replacement, 4.07 ± 1.74 g/dL. * Normal patients with Hb <10 g/dL should be worked up by a hematologist. transfusion requirements in patients undergoing total hip or knee arthro- plasty. 47,48 Aprotinin has had mixed results. In one study 49 of 40 patients who underwent total hip arthroplas- ty, those given aprotonin showed a significant (P < 0.05) reduction in blood loss from 1,943 to 1,446 mL and a decrease in mean blood trans- fusions from 3.4 to 1.8 units. Another study 50 of aprotonin showed no effect on blood loss or transfusion requirement. Tranexamic acid has been shown to reduce both postop- erative blood loss and transfusion requirements in patients undergoing total knee arthroplasty. 51,52 Blood Salvage Despite advances in surgical technique and the effective use of hemostatic agents, blood loss dur- ing orthopaedic procedures can be extensive. Blood salvage returns to the patient washed or unwashed autologous blood lost in surgery. The blood is collected by aspiration or drainage, filtered, and centri- fuged before transfusion. 10 Blood salvage can be applied both intraop- eratively and postoperatively. Intraoperative Blood Recovery Intraoperative recovery of autolo- gous blood requires special equip- ment and trained personnel. Cell- washing devices can provide the equivalent of 10 units of banked blood per hour. 1 However, because cell-washing does not completely remove bacteria from recovered blood, this technique should not be used if the surgical field has gross bacterial contamination. 53 Other contraindications for intraoperative blood recovery include the potential for aspiration of malignant cells, the presence of infection, or the presence of contaminants such as amniotic or ascitic fluid. 1 Deaths related to intraoperative blood recovery have been reported; estimated risk is 1 per 35,000 procedures. Interestingly, studies of patients undergoing either cardiothoracic surgery 54 or repair of abdominal aortic aneurysms 55 showed that intraoperative blood recovery did not result in fewer blood transfusions. However, intra- operative recovery still may be of value in patients with substantial blood loss during major ortho- paedic surgery because it provides less costly, immediately available blood. 1 At least 2 units need to be recovered for the method to be cost effective. 1 Postoperative Blood Recovery Postoperative recovery involves collecting blood from surgical drains followed by reinfusion, with or with- out processing. Because the recov- ered blood is diluted, defibrinated, and partially hemolyzed, and is likely to contain cytokines, there is gener- ally a threshold for the volume of unprocessed blood that can be rein- fused. This technique has been used most commonly after cardiac surgery. 1 The value of postoperative blood recovery in these patients is controversial; some studies demon- strate a benefit, 56 while others show no efficacy. 57 The safety and useful- ness of postoperative blood recovery after orthopaedic surgery also re- mains controversial. 58,59 Because of the high cost and questionable bene- fit of this technique, postoperative blood recovery should be limited to cases in which large postoperative blood losses are anticipated, such as in bilateral joint replacement sur- gery. 1 Summary Concern about the safety of allo- genic blood transfusion has led to notable refinements and new ap- proaches to blood conservation. 10 These efforts include the develop- ment of transfusion practice stan- dards, promotion of PAD, the clini- cal use of epoetin alfa to stimulate erythropoiesis, improvements in surgical practice, the use of hemo- static agents, and perioperative blood salvage. Despite these ad- vances, awareness must be raised regarding the significance of preop- erative Hb levels in predicting and reducing transfusion requirements in major orthopaedic surgery. A strategy for managing perioperative blood loss can minimize or elimi- nate the need for allogenic blood. The preoperative assessment of estimated blood loss and transfu- sion risk, and careful evaluation of alternative sources for replacement of blood, are key to optimizing blood management strategies. Sur- geons must be discriminating in their use of PAD, blood salvage, and epoetin alfa by carefully consid- ering the clinical status of individ- ual patients, specific surgical pro- cedures, potential adverse effects, and outcomes. Blood Management in Elective Orthopaedic Surgery Journal of the American Academy of Orthopaedic Surgeons 398 References 1. Goodnough LT, Brecher ME, Kanter MH, AuBuchon JP: Transfusion medi- cine: Second of two parts. Blood conser- vation. 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