The Journal of Bone and Joint Surgery 82:89-100 (2000)
© 2000 The Journal of Bone and Joint Surgery, Inc.
Preoperative Autologous Donation for Total Joint Arthroplasty. An Analysis of Risk Factors for Allogenic Transfusion*
ARMODIOS M. HATZIDAKIS, M.D. ,
MICHAEL R. MENDLICK, M.D. ,
TRACY McKILLIP, P.A.C. ,
RAM L. REDDY, M.D. and
KEVIN L. GARVIN, M.D. , OMAHA, NEBRASKA
Investigation performed at University of Nebraska Medical Center/Omaha Veterans Administration Medical Center, Omaha
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Abstract
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Background: While autologous blood is commonly predonated to provide replacement of blood lost in orthopaedic procedures, few studies of patients managed with total joint replacement have addressed the problem of which patients are likely to benefit from an autologous blood-donation program.
Methods: A retrospective analysis of 489 consecutive patients who had had a total joint arthroplasty was performed to identify the risk factors for allogenic transfusion and to further define the indications for preoperative autologous blood donation. The operations included 247 total knee replacements (157 unilateral primary, thirty-two revision, and twenty-nine one-stage bilateral primary procedures) and 271 total hip replacements (163 primary and 108 revision procedures). Fifty-four percent (264) of the 489 patients donated a total of 527 units of blood (average, 2.0 units per patient) preoperatively.
Results: One hundred and ninety-one patients (39 percent) required a transfusion of autologous blood or allogenic blood, or both. One hundred and thirty-one patients (27 percent) received autologous blood, and eighty-two patients (17 percent) received a transfusion of allogenic blood; twenty-two patients (4 percent) received both autologous and allogenic blood. Neither form of transfusion caused serious complications. Fifty-six percent (295) of the 527 units of autologous blood were discarded.
Autologous donation significantly decreased the requirements for allogenic transfusion (relative risk, 0.1; p < 0.0001). It also caused the level of hemoglobin to decrease an average of 12.2 grams per liter from the time before donation to the time before the operation (p < 0.0001). Factors that increased the risk for allogenic transfusion were a revision knee or hip procedure or a one-stage bilateral primary knee replacement (relative risk, 5.7; p < 0.0001), an initial hemoglobin level of less than 130 grams per liter (relative risk, 5.6; p < 0.0001), and an age of sixty-five years or older (relative risk, 2.8; p = 0.02). None of the sixty-seven patients who had a primary knee or hip arthroplasty and an initial hemoglobin level of 150 grams per liter or more required an allogenic transfusion. In addition, none of the sixty-three patients who had a primary arthroplasty, an initial hemoglobin level of between 130 and less than 150 grams per liter, and an age of less than sixty-five years required an allogenic transfusion. Eighty-three percent (115) of the 138 autologous units donated by the seventy patients in these two groups were discarded. These wasted units accounted for 39 percent of the 295 discarded units for the entire study sample.
Conclusions: The efficiency of collection of autologous blood can be improved by identifying patients who have a very low risk of transfusion according to the type of arthroplasty, the initial level of hemoglobin, and age. Patients who have an initial hemoglobin level of at least 150 grams per liter or an initial hemoglobin level of between 130 and 150 grams per liter and an age of less than sixty-five years have a minimal risk of needing a transfusion during or after a primary total joint replacement. These patients should be apprised of their low risk so that they can make an informed decision regarding preoperative autologous donation.
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Introduction
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The success of preoperative autologous donation programs in the last twenty years has established their important role in the care of patients having a total joint arthroplasty3-6,8,9,17,21,22,28,29,34,41,45,50,51,54-56. Transmission of acquired immunodeficiency syndrome and viral hepatitis is a feared complication of allogenic transfusion. Despite markedly decreased viral contamination of the current allogenic blood supply, the preference of surgeons and patients for autologous blood remains very strong5,28,29. Donation for joint replacement in the lower extremities has contributed to a marked rise in the collection of autologous blood in the United States53. About one-half of this blood is not transfused5,29. Most American blood banks and hospitals discard these units rather than incorporate them into the general blood supply5,29,44. One reason for this waste is that surgeons are frequently inaccurate in predicting how much blood will be required for each patient1,5,7,13,18. In addition, autologous blood has its own risks. Donation reactions (adverse events occurring as a result of blood collection) and transfusion reactions have been reported10,19,33,43,48,57. As with allogenic blood, the risk of transfusion error with autologous blood can result in a hemolytic transfusion reaction24,27,31,47,57. Donation-induced preoperative anemia increases the overall rates of transfusion in donors of autologous blood compared with nondonors, potentially amplifying the exposure to clerical error16,23,57.
The National Heart, Lung, and Blood Institute Expert Panel on the Use of Autologous Blood recently recommended that patients who have less than a 10 percent likelihood of needing perioperative transfusion should not be encouraged to donate37. Surprisingly, few studies of total joint replacement have determined which patients are likely to benefit from predonation of autologous blood. In the current study, we examined the perioperative variables that are independently associated with transfusion after joint arthroplasty. We hypothesized that three preoperative risk factorsthe type of procedure, the initial level of hemoglobin, and the patient's agecould be analyzed both separately and in combination to identify specific groups of patients for whom transfusion was common or uncommon. The purpose of our study was to analyze how autologous donation affected the need for subsequent allogenic transfusion in these cohorts and to define more specific indications for autologous donation before total joint replacement.
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Materials and Methods
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We requested the charts of 495 consecutive patients who had had a total joint arthroplasty performed at one of two institutions by one of two surgeons during a thirty-six-month period (between February 1, 1994, and January 31, 1997). Six charts were not available at the time of this study, limiting the review to 489 patients. Individual consent for participation in the study was not required because of its retrospective nature.
The operations included 247 total knee arthroplasties (157 unilateral primary, thirty-two revision, and twenty-nine one-stage bilateral primary procedures) and 271 total hip arthroplasties (163 primary and 108 revision procedures). The analyzed documents included the preoperative history and physical examination report, operative report, anesthesia record, nursing notes, transfusion records, and physician's progress notes. The preoperative data included the patient's age and gender, the indications for the operation, the presence of comorbid conditions, and whether the patient had participated in an autologous blood-donation program. The average age (and standard deviation) of the 489 patients was 65 ± 12.5 years. Two hundred and ninety patients (59 percent) were men, and 199 (41 percent) were women. The predonation and preoperative levels of hemoglobin also were analyzed. The initial hemoglobin level was defined as the first level that was measured, whether it was predonation or preoperative. We believed that use of this hemoglobin value for donors and nondonors of autologous blood would ensure that the two groups of patients were properly matched, independent of the potential phlebotomy-induced anemic effect of donation.
The indications for primary total knee arthroplasty (both unilateral and bilateral) and primary total hip arthroplasty included osteoarthritis, rheumatoid arthritis, posttraumatic arthritis, hemophilic arthropathy, avascular necrosis, congenital dysplasia, and acute fracture (Table I). The indications for revision total knee and hip arthroplasty included mechanical failure or loosening, infection, and periprosthetic fracture (Table I). Comorbid conditions included hypertension, a history of cardiac disease or cancer, diabetes mellitus, chronic obstructive pulmonary disease, hypothyroidism, and rheumatoid arthritis (Table II).
Before the operation, patients had been advised to donate blood at a local blood bank. The criteria for autologous donation included an absence of active infection or of uncontrolled cardiac disease and a preparticipation screening hemoglobin value of at least 110 grams per liter. Phlebotomy typically was performed weekly, although in some patients it was performed at three to five-day intervals. A patient was not allowed to donate if the hemoglobin value was less than 110 grams per liter at any time during the blood-acquisition process. No patient received human recombinant erythropoietin at any time14.
Two hundred and sixty-four patients donated blood for possible autologous transfusion. Oral administration of iron (ferrous sulfate) supplements, 325 milligrams three times per day, was initiated before donation. Predonation red blood-cell indices were available for 149 patients (56 percent) who donated at the Red Cross center. Both hemoglobin and hematocrit values were obtained for ninety-one (61 percent) of these patients before the first autologous donation, but only the hematocrit was determined for fifty-eight (39 percent). For these fifty-eight patients, a hemoglobin level was estimated by dividing the hematocrit value by three. The Red Cross records also were carefully reviewed for the occurrence of reactions to autologous donation.
Preoperative hemoglobin levels were available for 484 of the 489 patients. Other data that were analyzed included the type of anesthesia that was used and the estimated blood loss during the procedure. Intraoperative cell salvage (Cell Saver; Haemonetics, Braintree, Massachusetts) was performed for sixty-five patients, and reinfusion volumes were also included in the data analysis. Postoperative data included the total drain output, the indications for the transfusion, and the total transfusion requirements (Table III). In accordance with the recently established guidelines for red blood-cell transfusion41,49, an absolute indication for transfusion was an intraoperative or postoperative hemoglobin level of less than seventy grams per liter. Most of the patients, however, received the transfusion after identification of clinically based signs and laboratory findings that were consistent with symptomatic anemia. Symptomatic anemia was defined as a low level of hemoglobin (less than 120 grams per liter) associated with at least one of the following: persistent tachycardia that was refractory to intravenous administration of fluids, orthostatic hypotension, dyspnea on exertion, and profound fatigability that precluded participation in physical therapy. Elderly patients and patients who had preexisting myocardial disease were thought to have lower physiological reserve; thus, less stringent criteria for transfusion tended to be used for them. Full informed consent for blood transfusion was obtained preoperatively.
Statistical Analysis
Logistic regression analysis was used to examine the role of several factors (the type of procedure, the patient's age and gender, whether the patient had donated blood preoperatively, the preoperative hemoglobin level, comorbid conditions, the type of anesthesia, the estimated blood loss, the volume of intraoperative cell salvage returned, and postoperative drain outputs) in determining the requirements for allogenic transfusion. For the analysis of the type of procedure, primary procedures were compared with bilateral and revision operations. For the comparison of continuous variables, the Student t test was used. For the comparison of more than two groups, analysis of variance was performed with the Student-Newman-Keuls procedure for multiple comparisons. The chi-square test for association and Fisher's exact test were used to compare categorical variables. P values that were less than 0.05 were considered significant. For p values that were greater than 0.05, a power analysis was performed. Power calculations of 80 percent or greater were considered adequate to confirm a lack of association.
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Results
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Transfusion Requirements, Indications, and Complications
Fifty-four percent (264) of the 489 patients donated a total of 527 units of blood (average, 2.0 units per patient) for possible autologous transfusion. One hundred and ninety-one patients (39 percent) required a transfusion of autologous or allogenic blood, or both, and 229 transfusions (134 autologous and ninety-five allogenic) were performed. One hundred and nine patients (22 percent) received autologous blood only, sixty (12 percent) received allogenic blood only, and twenty-two (4 percent) required a transfusion of both forms of blood. Eighty-two patients (17 percent) had a transfusion of allogenic blood (total, 189 units). Two hundred and ninety-eight (61 percent) of the 489 patients and 132 (50 percent) of the 264 donors did not require a transfusion of either autologous or allogenic blood. Overall, 56 percent (295) of the 527 units of autologous blood were discarded. Eighty-nine percent (263) of the 295 units of discarded blood had been collected from the 132 donors who did not require a transfusion.
The hemoglobin level was available at the time of the transfusion decision for 109 (81 percent) of the 134 autologous transfusions and seventy (74 percent) of the ninety-five allogenic transfusions. The average hemoglobin level at the time of the 106 initial autologous transfusions (84.0 ± 10.5 grams per liter) was not significantly different from that at the sixty initial allogenic transfusions (83.0 ± 12.4 grams per liter) (p = 0.42, with an 80 percent power to detect a difference of five grams per liter). At the second autologous transfusion (three patients), the pre-transfusion hemoglobin level averaged 80.0 ± 2.0 grams per liter. At the second allogenic transfusion (ten patients), the pre-transfusion hemoglobin level averaged 84.5 ± 7.2 grams per liter. There was no significant difference in the hemoglobin level between the autologous and allogenic transfusions, regardless of the time when the transfusions were performed (p = 0.59, with an 80 percent power to detect a difference of six grams per liter). Clinical signs of anemia, such as tachycardia and hypotension, also were not significantly different between the allogenic and autologous transfusions, regardless of the time when the transfusions were performed (an 80 percent power to detect a difference of seven beats per minute in the pulse or a difference of eight millimeters of mercury [1.07 kilopascals] in the systolic or diastolic blood pressure).
Neither autologous nor allogenic transfusion caused serious complications in the patients who were studied. According to Red Cross and hospital records, there were no minor complications directly attributable to autologous blood donation. Postoperatively, eleven patients had a fever of more than 38.5 degrees Celsius as measured orally, within twenty-four hours after the transfusion. Six fevers occurred within twenty-four hours after an autologous transfusion and were attributable to atelectasis. Five febrile episodes occurred within twenty-four hours after an allogenic transfusion; four of the five were attributable to atelectasis, and one was diagnosed as a nonhemolytic febrile transfusion reaction. The overall rate of nonhemolytic febrile reactions to allogenic blood was therefore 1.2 percent (one of eighty-two recipients of allogenic blood). There were no bacterial, hemolytic, or sickle-cell transfusion reactions.
Effect of Blood Loss, Initial Hemoglobin Level, and Autologous Donation on Transfusion Requirements
Patients who did not require transfusion lost less blood intraoperatively (423 ± 372 milliliters) than those who required allogenic blood only (658 ± 411 milliliters; p < 0.002) or those who required both autologous and allogenic transfusion (909 ± 956 milliliters; p < 0.0001). Patients who required only autologous blood lost an average of 475 ± 370 milliliters of blood intraoperatively. Patients who did not require transfusion were younger (average age, 63.0 ± 12.5 years) than those who required allogenic blood only (average age, 73.3 ± 11.0 years; p < 0.0001) and those who required both autologous and allogenic transfusion (average age, 70.0 ± 8.7 years; p = 0.013). Drain outputs were not significantly different among the three groups (423 ± 308, 495 ± 338, and 463 ± 374 milliliters; p 0.19 for all comparisons, with an 80 percent power to detect a difference of 225 milliliters).
Patients who did not require transfusion had a higher average preoperative hemoglobin level (137.2 ± 12.2 grams per liter; 297 patients) than those who required autologous blood only (120.6 ± 13.4 grams per liter; 108 patients), those who received allogenic blood only (125.5 ± 16.0 grams per liter; fifty-eight patients), and those who received both forms of transfusion (119.6 ± 10.9 grams per liter; twenty-one patients) (p < 0.0001 for all comparisons).
Initial predonation hemoglobin levels were available for 56 percent (149) of the 264 donors. A preoperative hemoglobin level was not available for four of these 149 patients. Hemoglobin levels decreased from 139.0 ± 14.7 grams per liter (in 149 patients) before the first donation (twenty-two days before the operation) to 126.8 ± 14.3 grams per liter (in 145 patients) six days before the operation (p < 0.0001) in the group for which the predonation hemoglobin level was available. Preoperative hemoglobin levels were lower in the 261 donors than in the 223 nondonors (127.2 ± 14.7 grams per liter compared with 136.1 ± 17.1 grams per liter; p < 0.0001). Donors nonetheless had a significantly decreased rate of allogenic transfusion than did nondonors (9 percent [twenty-three] of 264 compared with 26 percent [fifty-nine] of 225; p < 0.0001). Fifty percent (132) of the 264 donors required an autologous transfusion (a total of 234 units). Fifty percent (133) of the 264 donors were men compared with 70 percent (157) of the 225 nondonors (p < 0.001).
Logistic Regression Analysis
Multivariate analysis revealed that autologous donation significantly decreased the risk for allogenic transfusion (relative risk, 0.1; p < 0.0001). Revision and one-stage bilateral joint replacement were associated with an increased risk for allogenic transfusion (relative risk, 5.7; p < 0.0001). Other factors associated with an increased risk for allogenic transfusion included a preoperative hemoglobin level of less than 130 grams per liter (relative risk, 5.6; p < 0.0001), an age of sixty-five years or older (relative risk, 2.8; p = 0.02), and an increased estimated intraoperative blood loss (per milliliter increase in relative risk, 0.001; p < 0.0001). Neither the type of anesthesia nor the presence of a comorbid condition had a significant effect on the requirement for allogenic transfusion (p > 0.05 for both variables), although the power to detect such associations was low (an 80 percent power to detect a relative risk of 2.3 to 6.2).
Individual Risk-Factor Analysis According to Type of Procedure
Patients who had a primary total knee arthroplasty had a lower rate of allogenic transfusion (6 percent [nine of 157]) than did those who had a revision total knee arthroplasty (28 percent [nine of thirty-two]) or those who had a bilateral total knee arthroplasty (34 percent [ten of twenty-nine]) (p < 0.001 for both comparisons). Sixty-two percent (eighty-two) of the 132 autologous units donated before primary total knee arthroplasties were discarded compared with 44 percent (twelve) of the twenty-seven units donated before revision knee replacements (p < 0.041) and only 20 percent (nine) of the forty-six units donated before bilateral total knee arthroplasties (p < 0.0005). More blood was lost intraoperatively during the revision knee replacements (average, 310 ± 308 milliliters; median, 250 milliliters; p = 0.004) and the bilateral knee replacements (average, 340 ± 211 milliliters; median, 250 milliliters; p = 0.0002) than was lost during the primary knee replacements (average, 185 ± 133 milliliters; median, 150 milliliters). Patients who had a bilateral total knee arthroplasty had a significantly higher postoperative drain output (average, 718 ± 406 milliliters; median, 750 milliliters) than did those who had a revision (average, 407 ± 311 milliliters; median, 350 milliliters; p < 0.0035) and those who had a primary total knee arthroplasty (average, 491 ± 352 milliliters; median, 475 milliliters; p < 0.0062). The postoperative drain outputs after revision and primary procedures were not significantly different (p = 0.31, with an 80 percent power to detect a difference of 194 milliliters) (Table III).
The rate of allogenic transfusion in the patients who had a primary total hip arthroplasty (11 percent [eighteen of 163]) was lower than that in the patients who had a revision total hip arthroplasty (33 percent [thirty-six of 108]) (p < 0.001). One hundred and twenty-eight (64 percent) of 201 units that were donated before primary total hip arthroplasties were discarded compared with sixty-four (53 percent) of 121 units that were donated before revision hip replacements (p < 0.018). Patients who had a revision total hip arthroplasty had a significantly higher intraoperative blood loss (average, 844 ± 556 milliliters; median, 750 milliliters) than did those who had a primary total hip arthroplasty (average, 503 ± 339 milliliters; median, 400 milliliters) (p < 0.0001). There was no significant difference, between the patients who had a primary hip procedure and those who had a revision, in the rate of participation in an autologous blood-donation program (61 percent [ninety-nine] of 163 compared with 55 percent [fifty-nine] of 108; p = 0.15, with an 80 percent power to detect a difference of 17 percent) or in the postoperative drain output (average, 381 ± 223 milliliters compared with 401 ± 328 milliliters; p = 0.92, with an 80 percent power to detect a difference of ninety-six milliliters). Intraoperative cell salvage was used for 48 percent (fifty-two) of the 108 revision procedures compared with only 5 percent (eight) of the 163 primary procedures (p < 0.001) (Table III).
Combination of the data for the knee and hip replacements revealed that 8 percent (twenty-seven) of the 320 patients who had a primary procedure required an allogenic transfusion compared with 33 percent (fifty-five) of the 169 who had a revision or bilateral procedure (p < 0.001) (Table IV). Two hundred and ten (63 percent) of the 333 autologous units that were donated before primary total joint replacements were discarded compared with eighty-five (44 percent) of the 194 units that were donated before revision or bilateral total joint replacements (p < 0.001) (Table IV). The estimated blood loss during the primary joint arthroplasties (average, 364 ± 312 milliliters) was significantly lower than that during the revision or bilateral replacements (average, 675 ± 538 milliliters) (p < 0.0001). The patients who had a primary total joint replacement were slightly younger (average age, 63.9 ± 12.3 years) than those who had a revision or bilateral procedure (average age, 67.2 ± 12.5 years) (p = 0.0045). Intraoperative cell salvage was used more often in revision and bilateral procedures (used in fifty-seven [34 percent] of 169 patients) than in primary procedures (used in eight [3 percent] of 320 patients) (p < 0.001). The use of the Cell Saver in revision procedures was not associated with a significant decrease in the requirement for allogenic transfusion in either nondonors (p = 0.63) or donors (p = 0.57), but the power to detect such associations was low (an 80 percent power to detect a difference of 28 percent).
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TABLE IV: RATES OF AUTOLOGOUS BLOOD DONATION, ALLOGENIC TRANSFUSION, AND UTILIZATION OF AUTOLOGOUS BLOOD UNITS ACCORDING TO SINGLE AND COMBINATION-RISK-FACTOR GROUPS*
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Initial Level of Hemoglobin and Age
Of the patients who had an initial hemoglobin concentration of 150 grams per liter or more, only 1 percent (one of eighty-five) required an allogenic transfusion. This rate was significantly lower than that for patients who had a hemoglobin level of 130 to less than 150 grams per liter (12 percent [twenty-six of 222]; p < 0.01) and that for those who had a hemoglobin level of less than 130 grams per liter (29 percent [fifty-two of 178]; p < 0.001) (Table IV). No patient who had an initial hemoglobin level of 130 to less than 150 grams per liter, had a primary arthroplasty, and was less than sixty-five years old required an allogenic transfusion. The autologous blood discard rate was highest in the group of patients who had an initial hemoglobin level of 150 grams per liter or more (82 percent [seventy-seven of ninety-four units]). The discard rates were lower for patients who had an initial hemoglobin level of 130 to less than 150 grams per liter (64 percent [149 of 233 units]; p = 0.033) and those who had a level of less than 130 grams per liter (36 percent [seventy-two of 199 units]; p < 0.0001) (Table IV). Men accounted for 37 percent (sixty-six) of the 178 patients who had a hemoglobin level of less than 130 grams per liter. The percentage of men was higher in the group that had a hemoglobin level of 130 to less than 150 grams per liter (65 percent [145 of 222]; p < 0.001) and in the group that had a level of more than 150 grams per liter (91 percent [seventy-seven of eighty-five]; p < 0.0001).
Patients who were less than sixty-five years old had a significantly lower rate of allogenic transfusion (6 percent [twelve of 193]) than did those who were sixty-five years old or more (24 percent [seventy of 296]; p < 0.001) (Table IV). Sixty-eight percent (164) of the 241 autologous units that were donated by patients less than sixty-five years old were discarded compared with 46 percent (131) of the 286 units that were donated by patients sixty-five years old or more (p < 0.001) (Table IV). The percentage of patients less than sixty-five years old who had a primary procedure (74 percent [143 of 193]) was greater than that of patients who were sixty-five years old or more (60 percent [177 of 296]) (p < 0.001). There were no significant differences between the two age-groups with regard to male:female ratio (p = 0.51, with an 80 percent power to detect a difference of 12 percent), estimated blood loss (p = 0.17, with an 80 percent power to detect a difference of 113 milliliters), postoperative drain output (p = 0.093, with an 80 percent power to detect a difference of eighty-three milliliters), percentage of procedures in which the Cell Saver was used (p = 0.89, with an 80 percent power to detect a difference of 10 percent), and preoperative hemoglobin level (p = 0.55, with an 80 percent power to detect a difference of five grams per liter).
Autologous blood donation significantly decreased the need for allogenic transfusion in all single-risk-factor groups except for the group with an initial hemoglobin level of 150 grams per liter or more and the group that was less than sixty-five years old. Autologous donation was particularly beneficial for patients undergoing revision hip and knee or bilateral knee arthroplasty, patients sixty-five years old or older, and patients with a hemoglobin level of less than 130 grams per deciliter (Table V).
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TABLE V: EFFECT OF AUTOLOGOUS DONATION ON RATES OF ALLOGENIC TRANSFUSION IN SINGLE AND COMBINATION-RISK-FACTOR GROUPS
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Risk-Factor Combinations and Effect of Autologous Donation
Patients who had any of three combinations of risk factors were hypothesized to have a very low risk of requiring a transfusion. These combinations included primary arthroplasty and an initial hemoglobin level of 150 grams per liter or more; primary arthroplasty and an initial hemoglobin level of 130 to less than 150 grams per liter; and primary arthroplasty, an initial hemoglobin level of 130 to less than 150 grams per liter, and an age of less than sixty-five years. These three groups of patients had very low rates of allogenic transfusion, and a high percentage of the autologous blood units in these groups were discarded (Table IV). None of sixty-seven patients (thirty-six nondonors and thirty-one donors) who had a primary total joint replacement and an initial hemoglobin level of 150 grams per liter or more required an allogenic transfusion. None of the thirty-six nondonors required a transfusion of any type. Sixteen percent (five) of the thirty-one donors had an autologous transfusion. Eighty-six percent (fifty-five) of the sixty-four autologous units that were collected from these patients were discarded (Table IV). The thirty-one donors had a lower average preoperative level of hemoglobin (142.7 ± 11.9 grams per liter) than did the thirty-six nondonors (159.7 ± 9.1 grams per liter) (p < 0.001). Ninety-three percent (sixty-two) of the sixty-seven donors and nondonors were men.
Five percent (seven) of the 150 patients who had a primary total joint replacement and a preoperative hemoglobin level of 130 to less than 150 grams per liter required an allogenic transfusion; all seven patients were sixty-five years or older. Despite the overall low rate of allogenic transfusion, autologous blood donation significantly decreased the need for allogenic blood in this group, with 10 percent (seven) of seventy-two nondonors compared with none of seventy-eight donors requiring an allogenic transfusion (p < 0.005). This difference was negated if patients sixty-five years or older were excluded (Table V). None of the sixty-three patients who were less than sixty-five years old, had a primary arthroplasty, and had an initial hemoglobin level of 130 to less than 150 grams per liter required an allogenic transfusion. None of the twenty-four nondonors required any type of transfusion. Of the thirty-nine donors, 18 percent (seven) had an autologous transfusion. Eighty-one percent (sixty) of the seventy-four autologous units that were collected from these patients were discarded (Table IV). The thirty-nine donors had a lower preoperative hemoglobin level (130.8 ± 10.2 grams per liter) than did the twenty-four nondonors (141.6 ± 10.3 grams per liter) (p < 0.001).
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Discussion
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Several complications are directly attributable to allogenic transfusion. Nonhemolytic febrile transfusion reactions, febrile allergic reactions, and alloimmunization reactions are most common but do not generally result in serious morbidity. More serious complications are much rarer2,20. The most feared risk of allogenic blood, infectious contamination, has declined substantially since 1985 secondary to improved criteria for the selection of donors and the advent of sensitive screening tests for the human immunodeficiency virus (1985) and the hepatitis-C virus (1990)2,20,38,46,57. The most common viral risk at this time is that of hepatitis, with a transmission rate of approximately one per 100,000 units transfused2,20,25,46,57; this represents a 10,000-fold decrease from the transmission rate in 1985. The rate of transmission of the human immunodeficiency virus is also exceptionally low (one per 200,000 to two million units)2,20,25,46. Although these viral risks are diminishing, there is the possibility that a new viral agent could contaminate the blood supply20. Nonetheless, considering the diminished prevalence of viral transmission, one of the most substantial risks at present is thought to be administrative error; approximately one incorrect unit is administered for every 19,000 units transfused30. Other serious complications include acute and delayed hemolytic transfusion reactions, bacterial contamination, transfusion-related lung injury, anaphylaxis, graft-versus-host disease, and Rh sensitization in women of childbearing age11,20. Some investigators have shown that exposure to allogenic blood increases susceptibility to cancer and infection8,15,29,36; however, others have challenged these findings32,52.
The high rates of viral contamination of allogenic blood in the 1960s and 1970s led to the introduction of autologous blood donation before operations for the treatment of scoliosis9,50,51. Additional investigations established the useful role of autologous blood donation in total joint replacement12,22,34,50,55,56. The advantages of autologous transfusion include the elimination of viral infection, transfusion-related lung injury, anaphylaxis, graft-versus-host disease, alloimmunization, and Rh sensitization11,21. In addition, preoperative blood donation provides a psychological benefit to patients as they feel that they are in more control of their care28. Nonetheless, the collection and transfusion of autologous blood are not problem-free57. Multiple phlebotomies can be inconvenient and time-consuming for the patient. In addition, mild donation reactions (vasovagal episodes) occur at an estimated frequency of two to five per 100 donations. Serious complications can occur but are much rarer19,33,43,48. Popovsky et al., in a 1995 review of more than 200,000 autologous blood donations, found a one-in-16,783-unit prevalence of donation-related complications necessitating hospitalization43. Vasovagal episodes accounted for most of these complications, but anginal attack, tetany, compartment syndrome, phlebitis, and vessel damage necessitating repair also occurred on occasion. Minor reactions to transfusion of autologous blood also can occur. The 1994 American Association of Blood Banks Annual Questionnaire demonstrated an overall rate of transfusion reaction of nine per 10,000 autologous transfusions56. Although most adverse transfusion reactions are febrile nonhemolytic reactions, rare occurrences of hemolytic, septic, and sickle-cell reactions to autologous transfusion also have been reported10,57.
Human error also applies to autologous transfusion. The Association of American Pathologists Comprehensive Transfusion Medicine Surveys of 1992 and 1993 found that forty-two (0.7 percent) of 5681 institutions reported transfusion of incorrect autologous units57. Currently, the estimated risk of transfusion of an incorrect unit of autologous blood is one per 16,000 to 30,000 units transfused30,31,57. We and others9,12,16,23,55 found that donors had a significant decrease in hemoglobin and hematocrit levels, ranging from ten to sixteen grams per liter. Donation-induced anemia can lead to higher overall rates of transfusion, theoretically amplifying the exposure of autologous donors to error16,23,57. To our knowledge, however, there have been no reports of fatality due to the transfusion of incorrect units of autologous blood.
There is a need for increased efficiency in the collection of autologous blood5,21,29,37,44. Renner et al., in a study of transfusion practices in 612 hospitals, reported an overall rate of nonutilization of autologous blood of 40 percent44. Twenty percent (8037) of all 40,163 autologous units were donated for operations that were associated with less than a 10 percent risk that a transfusion would be needed44. In the current series, 89 percent (263) of the 295 units of discarded blood had been collected from patients who did not require a transfusion. In a recent prospective, multicenter analysis of more than 9000 patients who had a joint replacement, Bierbaum et al. found a 45 percent rate of wastage of autologous blood (4464 of 9920 units)5. The current study revealed a comparably high discard rate of 56 percent (295 of 527 units). The financial burden of discarded autologous blood is borne by the patient, the hospital, and the medical system5,7,13. This cost can potentially be reduced by better-defined indications for donation.
In a study of 299 patients who had a total hip arthroplasty, Nuttall et al. performed a stepwise regression analysis to identify those who were at high and low risk for transfusion39. The authors found that the preoperative hemoglobin level, weight, estimated blood loss, and use of aspirin were factors that affected the need for allogenic transfusion. In a prospective, follow-up investigation, Nuttall et al. used these risk factors to order a more appropriate quantity of allogenic red blood cells, predicting the actual need for transfusion with greater accuracy40. They also suggested that patients who have a primary total hip arthroplasty and a preoperative hemoglobin level of at least 150 grams per liter have only a slight likelihood of requiring a postoperative transfusion39. However, Nuttall et al. did not address the impact of autologous donation on the need for transfusion39,40. Biesma et al. showed that, for total hip replacement, donation of two units of autologous blood was as effective as donation of four units in decreasing the need for allogenic transfusion6. Although they recommended an overall reduction in autologous donation, the authors did not identify specific patients who had a particularly low need for transfusion. Bernstein et al. recommended that patients who had a primary total knee arthroplasty and a hemoglobin level of more than 150 grams per liter not donate blood for possible autologous transfusion4. Knight et al. suggested that the need for allogenic transfusion was minimum for patients who had a primary total knee arthroplasty, a preoperative hematocrit of more than 40 percent, and a weight of more than 130 pounds (fifty-nine kilograms)26. It was concluded that autologous donation was of negligible benefit for these patients. Neither of these studies included patients who had a total hip arthroplasty.
Like most published reports regarding autologous blood donation before total joint replacement, the current investigation was not a prospective, randomized trial4,5,7,8,12,16,22,34,50,51,54-56. Nonetheless, the number of patients was sufficient to achieve significance in the logistic regression analysis and the single-risk-factor comparisons that were performed. Predonation red blood-cell indices were available for 149 of the 264 donors, and, similar to the findings of other investigators3,9,12,14,16,23,38,56, preoperative donation-induced reductions in the levels of hemoglobin were shown to be significant (p < 0.0001). The timing and amount of blood predonation were variable, with the last donation occurring anywhere from twenty-seven to four days before the operation. Blood donations within two weeks before the operation are particularly likely to cause preoperative anemia because of an insufficient erythropoietic response24,27. Standardization of donation schedules, with the last donation occurring at least two weeks before the operation, could have minimized the rate of postdonation anemia in our study population, but this standardization would be difficult to achieve even in prospective protocols. Finally, the effect of the patient's weight, a factor used in other studies to determine the risk of transfusion26,39,40, was not analyzed in this study. We believe that variables such as the type of procedure, the preoperative level of hemoglobin, and age are better choices for protocol parameters than weight, as they more directly reflect blood loss, oxygen-carrying capacity, and physiological reserve.
To our knowledge, this is the first study of total knee and hip arthroplasty in which patients who were at low risk for needing a transfusion were identified according to the type of procedure, the initial hemoglobin level, and age. Bierbaum et al. thought that patients with a hemoglobin level of 137 grams per liter had a lesser likelihood of requiring a transfusion in association with a total joint arthroplasty than did their more anemic counterparts5. The current study supports this contention, as the patients who did not require an allogenic transfusion had an average preoperative hemoglobin level of 137.2 ± 12.2 grams per liter (297 patients). The indications for autologous and allogenic blood transfusion in our study sample did not differ, as evidenced by similar levels of hemoglobin at the time of the autologous and allogenic transfusions (84.0 ± 10.5 compared with 83.0 ± 12.4 grams per liter, respectively). No patient had a recognized complication related to having or not having had a blood transfusion.
We continue to recommend autologous donation to most patients having a total joint replacement because of its beneficial effect in reducing exposure to allogenic transfusion21,29,55. Furthermore, from an ethical and medicolegal standpoint, it is important to make autologous blood donation available to all patients having a total joint replacement, including those with a very low risk of needing a transfusion17. Nonetheless, the 50 percent wastage rate of current protocols is an issue that should be addressed and improved. In an attempt to increase the efficiency of autologous predonation programs, the National Heart, Lung, and Blood Institute Expert Panel of 1995 recommended that patients with less than a 10 percent likelihood of needing a transfusion not be urged to donate blood for possible autologous transfusion37. The goal of our investigation was to determine how to identify these low-risk individuals before total joint arthroplasty.
Consideration of the type of operation, the preoperative level of hemoglobin, and age can assist the surgeon in preoperatively determining the risk of a transfusion being needed. In the current investigation, a 0 percent rate of allogenic transfusion was found in two groups of patients: those who had a primary total joint replacement and an initial hemoglobin level of at least 150 grams per liter and those who had a primary total joint replacement, an initial hemoglobin level of 130 to less than 150 grams per liter, and an age of less than sixty-five years. This minimal risk for exposure to allogenic blood in these patients was unaffected by the availability of autologous blood. We believe that these two groups of patients did not require blood because they had optimum parameters for avoiding transfusionthe lowest amount of blood loss in conjunction with the highest or a high-normal hemoglobin level and a younger age (and thus a higher cardiovascular reserve). Twenty-seven percent (130) of our 489 patients fulfilled these criteria. The discarded autologous blood that had been donated by these patients accounted for 39 percent (115) of the 295 units discarded in the entire study sample. Decreasing autologous donations from these patients affords the opportunity to improve the overall efficiency of autologous collection programs for total joint replacementwithout causing an increase in exposure to allogenic blood. If a patient's proposed type of arthroplasty, initial level of hemoglobin, and age place him or her in one of these two groups, we explain to the patient that the risk of transfusion is very slight and is unlikely to be markedly affected by the donation of autologous blood. With this in mind, patients can make an adequately informed decision regarding autologous donation before a total joint replacement.
Note: The authors thank David Huberty, B.A., for his assistance with completion of this project.
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Footnotes
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*No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. No funds were received in support of this study.
Department of Orthopaedics, University of Nebraska Medical Center/Omaha Veterans Administration Medical Center, 600 South 42nd Street, Omaha, Nebraska 68198-1080.
American Red Cross Midwest Regional Blood Services, 3838 Dewey Avenue, Omaha, Nebraska 68105-1196.
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