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Transfusion Safety: Avoiding Unnecessary Bloodshed
Mayo Clinic Proceedings
January 2000
Volume 75 Number 1
BJmmfD Transfusion Safety: Avoiding Unnecessary Bloodshed "The safest blood is your own" has been the mantra ofblood bank medical directors for more than a quarter of a century. The principles of autologous blood collection-preoperative deposit, intraoperative salvage, and postoperative recovery-were taught to a generation of residents, nurses, and technologists and were included in virtually every educational program involving blood transfusion. For much ofthis period, however, the practice was honored primarily in the breach. Except in a few institutions where staff evolved an investigational interest in autologous techniques, little autologous transfusion was actually practiced.'
tient undergoing open heart surgery at the National Institutes of Health in the late 1960s had almost a I in 3 chance of contracting hepatitis from blood transfusion.' The incidence rates of what we then called non-A, non-B hepatitis were as high as 21%. Even after implementation of hepatitis B screening and conversion to an all-volunteer blood donor supply in the late 1970s, the risk of transfusiontransmitted hepatitis approached IO%. Today, the combination of volunteer blood, stringent donor eligibility criteria, and sensitive testing has reduced the risk of posttransfusion hepatitis to about I infection per 100,000 U transfused, a risk so low that it can no longer be measured accurately with prospective studies but must be estimated from mathematical models.' The impending introduction of blood screening technology using nucleic acid-based tests to detect the viruses directly promises to reduce the risk even further. If the success in reducing posttransfusion hepatitis has been gratifying, the virtual elimination of transfusiontransmitted human immunodeficiency virus (HIV) has been nothing less than spectacular. Models for estimating the risk of HIV-I transmission through blood in San Francisco, Calif, indicate a rate approaching I infection for every 100 U transfused even before the first patient presented with the clinical syndrome that we now associate with AIDS in 198J.5 By 1982, before the first cluster of immune-impaired hemophilia patients was recognized and months before the case of the first child with suspected transfusion-related AIDS was published, the risk approximated an astounding 1.1% per transfused unit. The magnitude of the risk could not have been appreciated and has been recognized only in retrospect. With the identification and deferral of donors with high-risk activities in 1983 and the introduction of HIV antibody testing in March of 1985, this risk declined dramatically. Through June 1999, approximately 65 million patients have been transfused with tested blood and blood components, and only 38 adults and 2 children have developed AIDS after receiving blood that screened negative for HfV." The current estimated risk is about I infection per I million U transfused. Put a different way, I am unlikely to see an HIV infection caused by allogeneic blood in this hospital for the next 100 years. As
See also page 10. The acquired immunodeficiency syndrome (AIDS) epidemic and its early association with blood transfusion changed transfusion practice dramatically. For more than a decade the public has demanded autologous blood, and physicians have dutifully collected and stored it, frequently for patients who had little chance of requiring transfusion. Some states went so far as to pass laws mandating that surgical patients have the option of autologous transfusion explained and the opportunity to donate preoperative autologous blood provided.' Accordingly, it came as no surprise that some 50% to 60% of preoperative autologous donations went unused or that autologous units were transfused inappropriately to patients who did not need them, according to medically accepted transfusion guidelines. Preoperative autologous donation came to represent an insurance policy of sorts to prevent or minimize a patient's exposure to a blood supply that had been widely, if somewhat unfairly, characterized as "tainted." If the truth be told, autologous blood "insurance" would have been an uncommonly good investment in the 1960s and the early 1980s. Allogeneic transfusions were administered more freely in those times, and the risks of allogeneic blood were both underestimated and unappreciated. A paAddress reprint requests and correspondence to Harvey G. Klein, MD, Department of Transfusion Medicine, Warren G. Magnuson Clinical Center, National Institutes of Health, Bldg 10, Room 1C711, 9000 Rockville Pike, Bethesda, MD 20892.
MayoClinProc. 2000;75:5-7
5
© 2000 Mayo Foundation for Medical Education and Research
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
Mayo Coo Proc, January 2000, Vol 75
tragic as any transfusion-associated HIV infection may be, the protective measures introduced between 1983 and the present reflect a remarkable story of success. How safe is the blood supply today? The risk-benefit calculus of allogeneic transfusion has clearly changed. Trite as it may sound, blood is safer than ever-by at least an order of magnitude. Clinically important viral infections other than hepatitis and HIV occur but are unusual. Cytomegalovirus transmission threatens premature infants and some immunosuppressed transplant recipients, but this risk can be minimized by recruiting seronegative donors or by using leukoreduced components. Infections that cause devastating problems in the developing world are thankfully rare in the United States. Transfusion-transmitted malaria occurs about once in every 4 million red blood cell transfusions, and only 5 cases of Chagas disease have been attributed to transfusion in the United States. However, we live in a global village and can certainly anticipate the intrusion of variant retroviruses and other agents not currently detected by our screening safety net. The Department of Health and Human Services has constructed a comprehensive safety vigilance system to address this concern.? For the worried well, tick-borne agents and especially spongiform encephalopathies (eg, Jakob-Creutzfeld disease [CJD], new-variant CID associated with bovine spongiform encephalopathy) have received an astonishing amount of notoriety given the singular lack of evidence that they pose a risk to the blood supply. We have come to expect this kind of legacy in the aftermath of the devastation wreaked on recipients of HIV-infected blood. Not all adverse transfusion events result from infectious agents." Alloimmunization to red blood cell, platelet, protein, and leukocyte antigens occurs after transfusion of allogeneic blood and may complicate future transfusions. Febrile reactions are still common but pose more of an inconvenience to patient and physician than a significant health risk. Transfusion-related acute lung injury, caused by potent leukoagglutinating antibodies in the donor's plasma, may complicate as many as 1 in every 5000 transfusions, but the injury is not often severe enough to require supportive therapy. Transfusion-associated anaphylaxis and graft-vs-host disease remain feared complications of transfusion, but they are sufficiently uncommon to defy meaningful statistical analysis. New information has associated a variety of immunomodulatory effects with allogeneic blood exposure; however, careful prospective studies are conflicting and the importance of these findings remains unresolved." Autologous predeposit transfusion programs do not reduce several risks of blood transfusion. Among the greatest of these is accidental administration of the wrong unit. Incredible as it may seem, mistaken transfusion occurs as often as once in every 12,000 allogeneic transfusions and is the leading cause of fatal hemolytic transfusion reactions,
Editorial
6
now estimated to occur once in every 600,000 U transfused." Studies of errors associated with autologous transfusion in Canada report an error rate of 1 in 149 U, most of which resulted in units that could not be transfused to the donor or in the donor receiving allogeneic blood. 11 Of far greater concern is a report from a 1992 US survey by the College of American Pathologists that almost 1% of institutions surveyed issued autologous blood to the wrong patient on at least 1 occasion in the previous year, and nearly half of these facilities transfused autologous blood to the wrong patient on more than 1 occasion." Bacterial contamination of blood components represents another underreported and poorly appreciated risk of transfusion and one that may in fact be increased by autologous blood collection. Microbial contamination, estimated as high as 1 in every 2500 platelet concentrates stored at room temperature and less frequently in red blood cell units stored at refrigerator temperatures, comes from skin contaminants at the phlebotomy site and from the transient bacteremia that all of us experience. Bacterial growth in stored blood results in several patient deaths each year. 13 There are currently no effective screening techniques to detect microbial contamination. Since autologous donors are patients or potential patients and are not required to meet the stringent screening criteria developed for volunteer donors, we should expect more frequent bacterial contamination of components drawn from those subjects who have indwelling catheters and poor general health status. Deaths from predeposited autologous units contaminated with bacteria have been reported. 12 Part of the risk-benefit analysis must include the potential risks to the donor of autologous blood. In a review of 5660 donations from subjects not meeting routine screening criteria, donor reaction rates were higher (4.3% vs 2.7%), although most reactions were considered minor." However, other studies that included such hemodynamic monitoring as blood pressure, cardiac output, electrocardiographic, and pulse oximetry studies detected disturbing hemodynamic changes in otherwise asymptomatic patients. If phlebotomy places some hemodynamically compromised patients at risk, the benefits of autologous blood are quickly nullified. Even a small increase in fatality rate (1/101,000) negates all benefits associated with autologous donation for coronary artery bypass grafting." In fact, 1 study reports the frequency of adverse events serious enough to merit hospitalization as 1 in 16,783 autologous donations, 12 times as high as the risk associated with donation by healthy volunteers. 16 For the first time in more than a decade, the number of autologous collections appears to be declining. While the reasons are not entirely clear, this observation may have serious implications for overall blood availability. Autologous blood collections benefit the community by generating additional units of blood from individuals who might not
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
Mayo Coo Proc, January 2000, Vol 75
ordinarily be eligible donors. While these units are not available to the general blood supply, they do replace allogeneic units and therefore comprise a small but important portion of the national blood supply. In 1997, 643,000 autologous units were collected, a decrease of 36.5% from 1994.17 One reason for the decline in autologous collections involves efforts to make autologous predonation strategies data driven and therefore more rational. Most approaches have centered on defining those patients most likely to benefit from autologous transfusion. One such approach has been taken by Nuttall et al" in this issue of the Proceedings. They attempted to determine the predictors of erythropoiesis in patients electing preoperative autologous donation for hip arthroplasty. From a retrospective analysis of 165 patients undergoing total hip arthroplasty, these investigators have derived guidelines for preoperative autologous blood collection that promise to increase the efficiency of the procedure. As the authors recognize, their approach is currently only a first approximation---ergo, in the title of their article, it is a "possible" guideline. Their protocol contains many assumptions, and it needs to be validated by a prospective trial. Then the protocol should be tested in other surgical settings and in other institutions and compared with existing algorithms." Periodic reevaluation is important, since improvements in surgical technique may modify the blood requirement or obviate need entirely. Efforts to apply controlled studies to make more efficient use of predonations and limit donor risk are clearly a good thing. Some observers fear that reduced collections reflect less concern with risk-benefit and rational use than with the rising costs of autologous units in a cost-driven medical economy. Autologous collections are more costly since they require more professional time, special handling, labeling, storage, and inventory management. Reimbursement is notoriously insufficient, especially if the autologous unit is not transfused. Arguments based on costeffectiveness point at costs ranging from $235,000 to over $23 million per patient quality -adjusted life-year." If these are accurate, the increased protection afforded by autologous blood comes at a steep price. There is a final lesson for physicians to remember from the experience with transfusion-transmitted HIY. While our current safety net seems effective against known infectious risks, a newly emerging blood-transmitted agent with a long incubation period or interval of silent infection would not likely be prevented by all the precautions now in place. The chance that such an agent might emerge is small but finite, and it is the patient's perception of risk, not that of the physician, the health insurer, or the framer of health policy, that we must balance against statistics involving death, disability, and dollars. Studies show that people tend to overestimate "dread risks" (those over which they have no control and that have catastrophic consequences) and "unknown risks.'?" Such concerns may not be sufficient reason to return
Editorial
7
to the irrational and costly overcollection of autologous blood. However, some patients will inevitably demand this expensive insurance against the most remote possibility. Perhaps those who wish additional insurance should be charged an additional private premium. Harvey G. Klein, MD Warren G. Magnuson Clinical Center National Institutes of Health Bethesda, Md REFERENCES 1. 2. 3.
4. 5.
6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18.
19. 20. 21. 22.
Toy PT, Strauss RG. Stehling LC, et al. Predeposited autologous blood for elective surgery: a national multicenter study. N Engl J Med. 1987;316:517-520. Paul Gann Blood Safety Act, §1645 of the California Health and Safety Code, effective January I, 1990. Alter HJ, Reesink HW, Nishioka K. New trends in blood banking. In: IX Triennial International Symposium on Viral Hepatitis and Liver Disease, Rome, Italy. Turin, Italy: Edzioni Minerva Medica; 1997:358-362. Schrieber GB, Busch MP, Kleinman SH, Korelitz Ll, Retrovirus Epidemiology Donor Study. The risk of transfusion-transmitted viral infections. N EnglJ Med. 1996;334:1685-1690. Busch MP, Young MJ, Samson SM, Mosley JW, Ward JW, PerkinsHA, Transfusion Safety Study Group. Risk of human immunodeficiency virus (HlV) transmission by blood transfusions before the implementation of HlV-I antibody screening. Transfusion. 1991;31:4-11. Centers for Disease Control and Prevention. Table 5: AIDS cases by age group, exposure category, and sex. HIVIAIDS Surveill Rep. 1999;11(1): 12. Busch M, Chamberland M, Epstein J, Kleinman S, Khabbaz R, Nemo G. Oversight and monitoring of blood safety in the United States. Vox Sang. 1999;77:67-76. Klein HG. Allogeneic transfusion risks in the surgical patient. Am J Surg. 1995;170(suppI6A):21-26. Klein HG. Immunomodulatory aspects of transfusion: a once and future risk? Anesthesiology. 1999;91:861-865. Linden JV, Paul B, Dressler KP. A report of 104 transfusion errors in New York State. Transfusion. 1992;32:601-606. Goldman M, Remy-Prince S, Trepanier A, Decary F. Autologous donation error rates in Canada. Transfusion. 1997;37:523-527. Linden JV, Kruskall MS. Autologous blood: always safer? [editorial]. Transfusion. 1997;37:455-456. Klein HG, Dodd RY, Ness PM, Fratantoni JA, Nemo GJ. Current status of microbial contamination of blood components: summary of a conference. Transfusion. 1997;37:95-101. Popovsky MA, Whitaker B, Arnold NL. Severe outcomes of allogeneic and autologous blood donations: frequency and characterization. Transfusion. 1995;35:734-737. AuBuchon JP, Popovsky MA. The safety of preoperative autologous blood donation in the nonhospital setting. Transfusion. 1991;31:513-517. Spiess BD, Sassetti R, McCarthy RJ, Narbone RF, Tuman KJ, Ivankovich AD. Autologous blood donation: hemodynamics in a high-risk patient population. Transfusion. 1992;32: 17-22. National Blood Donor Resource Center. Report on Blood Collection and Transfusion in the United States in 1997. Bethesda, Md: National Blood Donor Resource Center; 1999. Nuttall GA, Santrach PJ, Oliver WC Jr, et al. Possible guidelines for autologous red blood cell donations before total hip arthroplasty based on the surgical blood order equation. Mayo Clin Proc. 2000;75:10-17. Axelrod FB, Pepkowitz SH, Goldfinger D. Establishment of a schedule of optimal preoperative collection of autologous blood. Transfusion. 1989;29:677-680. Birkmeyer JD, AuBuchon JP, Littenberg B, et al. Cost-effectiveness of preoperative autologous donation in coronary artery bypass grafting. Ann Thorac Surg. 1994;57: 161-168. Etchason J, Petz L, Keller E, et al. The cost effectiveness of preoperative autologous blood. N EnglJ Med. 1995;332:719-724. Slovic P. Perception of risk. Science. 1987;236:280-285.
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
January 2000
Volume 75 Number 1
BJmmfD Transfusion Safety: Avoiding Unnecessary Bloodshed "The safest blood is your own" has been the mantra ofblood bank medical directors for more than a quarter of a century. The principles of autologous blood collection-preoperative deposit, intraoperative salvage, and postoperative recovery-were taught to a generation of residents, nurses, and technologists and were included in virtually every educational program involving blood transfusion. For much ofthis period, however, the practice was honored primarily in the breach. Except in a few institutions where staff evolved an investigational interest in autologous techniques, little autologous transfusion was actually practiced.'
tient undergoing open heart surgery at the National Institutes of Health in the late 1960s had almost a I in 3 chance of contracting hepatitis from blood transfusion.' The incidence rates of what we then called non-A, non-B hepatitis were as high as 21%. Even after implementation of hepatitis B screening and conversion to an all-volunteer blood donor supply in the late 1970s, the risk of transfusiontransmitted hepatitis approached IO%. Today, the combination of volunteer blood, stringent donor eligibility criteria, and sensitive testing has reduced the risk of posttransfusion hepatitis to about I infection per 100,000 U transfused, a risk so low that it can no longer be measured accurately with prospective studies but must be estimated from mathematical models.' The impending introduction of blood screening technology using nucleic acid-based tests to detect the viruses directly promises to reduce the risk even further. If the success in reducing posttransfusion hepatitis has been gratifying, the virtual elimination of transfusiontransmitted human immunodeficiency virus (HIV) has been nothing less than spectacular. Models for estimating the risk of HIV-I transmission through blood in San Francisco, Calif, indicate a rate approaching I infection for every 100 U transfused even before the first patient presented with the clinical syndrome that we now associate with AIDS in 198J.5 By 1982, before the first cluster of immune-impaired hemophilia patients was recognized and months before the case of the first child with suspected transfusion-related AIDS was published, the risk approximated an astounding 1.1% per transfused unit. The magnitude of the risk could not have been appreciated and has been recognized only in retrospect. With the identification and deferral of donors with high-risk activities in 1983 and the introduction of HIV antibody testing in March of 1985, this risk declined dramatically. Through June 1999, approximately 65 million patients have been transfused with tested blood and blood components, and only 38 adults and 2 children have developed AIDS after receiving blood that screened negative for HfV." The current estimated risk is about I infection per I million U transfused. Put a different way, I am unlikely to see an HIV infection caused by allogeneic blood in this hospital for the next 100 years. As
See also page 10. The acquired immunodeficiency syndrome (AIDS) epidemic and its early association with blood transfusion changed transfusion practice dramatically. For more than a decade the public has demanded autologous blood, and physicians have dutifully collected and stored it, frequently for patients who had little chance of requiring transfusion. Some states went so far as to pass laws mandating that surgical patients have the option of autologous transfusion explained and the opportunity to donate preoperative autologous blood provided.' Accordingly, it came as no surprise that some 50% to 60% of preoperative autologous donations went unused or that autologous units were transfused inappropriately to patients who did not need them, according to medically accepted transfusion guidelines. Preoperative autologous donation came to represent an insurance policy of sorts to prevent or minimize a patient's exposure to a blood supply that had been widely, if somewhat unfairly, characterized as "tainted." If the truth be told, autologous blood "insurance" would have been an uncommonly good investment in the 1960s and the early 1980s. Allogeneic transfusions were administered more freely in those times, and the risks of allogeneic blood were both underestimated and unappreciated. A paAddress reprint requests and correspondence to Harvey G. Klein, MD, Department of Transfusion Medicine, Warren G. Magnuson Clinical Center, National Institutes of Health, Bldg 10, Room 1C711, 9000 Rockville Pike, Bethesda, MD 20892.
MayoClinProc. 2000;75:5-7
5
© 2000 Mayo Foundation for Medical Education and Research
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
Mayo Coo Proc, January 2000, Vol 75
tragic as any transfusion-associated HIV infection may be, the protective measures introduced between 1983 and the present reflect a remarkable story of success. How safe is the blood supply today? The risk-benefit calculus of allogeneic transfusion has clearly changed. Trite as it may sound, blood is safer than ever-by at least an order of magnitude. Clinically important viral infections other than hepatitis and HIV occur but are unusual. Cytomegalovirus transmission threatens premature infants and some immunosuppressed transplant recipients, but this risk can be minimized by recruiting seronegative donors or by using leukoreduced components. Infections that cause devastating problems in the developing world are thankfully rare in the United States. Transfusion-transmitted malaria occurs about once in every 4 million red blood cell transfusions, and only 5 cases of Chagas disease have been attributed to transfusion in the United States. However, we live in a global village and can certainly anticipate the intrusion of variant retroviruses and other agents not currently detected by our screening safety net. The Department of Health and Human Services has constructed a comprehensive safety vigilance system to address this concern.? For the worried well, tick-borne agents and especially spongiform encephalopathies (eg, Jakob-Creutzfeld disease [CJD], new-variant CID associated with bovine spongiform encephalopathy) have received an astonishing amount of notoriety given the singular lack of evidence that they pose a risk to the blood supply. We have come to expect this kind of legacy in the aftermath of the devastation wreaked on recipients of HIV-infected blood. Not all adverse transfusion events result from infectious agents." Alloimmunization to red blood cell, platelet, protein, and leukocyte antigens occurs after transfusion of allogeneic blood and may complicate future transfusions. Febrile reactions are still common but pose more of an inconvenience to patient and physician than a significant health risk. Transfusion-related acute lung injury, caused by potent leukoagglutinating antibodies in the donor's plasma, may complicate as many as 1 in every 5000 transfusions, but the injury is not often severe enough to require supportive therapy. Transfusion-associated anaphylaxis and graft-vs-host disease remain feared complications of transfusion, but they are sufficiently uncommon to defy meaningful statistical analysis. New information has associated a variety of immunomodulatory effects with allogeneic blood exposure; however, careful prospective studies are conflicting and the importance of these findings remains unresolved." Autologous predeposit transfusion programs do not reduce several risks of blood transfusion. Among the greatest of these is accidental administration of the wrong unit. Incredible as it may seem, mistaken transfusion occurs as often as once in every 12,000 allogeneic transfusions and is the leading cause of fatal hemolytic transfusion reactions,
Editorial
6
now estimated to occur once in every 600,000 U transfused." Studies of errors associated with autologous transfusion in Canada report an error rate of 1 in 149 U, most of which resulted in units that could not be transfused to the donor or in the donor receiving allogeneic blood. 11 Of far greater concern is a report from a 1992 US survey by the College of American Pathologists that almost 1% of institutions surveyed issued autologous blood to the wrong patient on at least 1 occasion in the previous year, and nearly half of these facilities transfused autologous blood to the wrong patient on more than 1 occasion." Bacterial contamination of blood components represents another underreported and poorly appreciated risk of transfusion and one that may in fact be increased by autologous blood collection. Microbial contamination, estimated as high as 1 in every 2500 platelet concentrates stored at room temperature and less frequently in red blood cell units stored at refrigerator temperatures, comes from skin contaminants at the phlebotomy site and from the transient bacteremia that all of us experience. Bacterial growth in stored blood results in several patient deaths each year. 13 There are currently no effective screening techniques to detect microbial contamination. Since autologous donors are patients or potential patients and are not required to meet the stringent screening criteria developed for volunteer donors, we should expect more frequent bacterial contamination of components drawn from those subjects who have indwelling catheters and poor general health status. Deaths from predeposited autologous units contaminated with bacteria have been reported. 12 Part of the risk-benefit analysis must include the potential risks to the donor of autologous blood. In a review of 5660 donations from subjects not meeting routine screening criteria, donor reaction rates were higher (4.3% vs 2.7%), although most reactions were considered minor." However, other studies that included such hemodynamic monitoring as blood pressure, cardiac output, electrocardiographic, and pulse oximetry studies detected disturbing hemodynamic changes in otherwise asymptomatic patients. If phlebotomy places some hemodynamically compromised patients at risk, the benefits of autologous blood are quickly nullified. Even a small increase in fatality rate (1/101,000) negates all benefits associated with autologous donation for coronary artery bypass grafting." In fact, 1 study reports the frequency of adverse events serious enough to merit hospitalization as 1 in 16,783 autologous donations, 12 times as high as the risk associated with donation by healthy volunteers. 16 For the first time in more than a decade, the number of autologous collections appears to be declining. While the reasons are not entirely clear, this observation may have serious implications for overall blood availability. Autologous blood collections benefit the community by generating additional units of blood from individuals who might not
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.
Mayo Coo Proc, January 2000, Vol 75
ordinarily be eligible donors. While these units are not available to the general blood supply, they do replace allogeneic units and therefore comprise a small but important portion of the national blood supply. In 1997, 643,000 autologous units were collected, a decrease of 36.5% from 1994.17 One reason for the decline in autologous collections involves efforts to make autologous predonation strategies data driven and therefore more rational. Most approaches have centered on defining those patients most likely to benefit from autologous transfusion. One such approach has been taken by Nuttall et al" in this issue of the Proceedings. They attempted to determine the predictors of erythropoiesis in patients electing preoperative autologous donation for hip arthroplasty. From a retrospective analysis of 165 patients undergoing total hip arthroplasty, these investigators have derived guidelines for preoperative autologous blood collection that promise to increase the efficiency of the procedure. As the authors recognize, their approach is currently only a first approximation---ergo, in the title of their article, it is a "possible" guideline. Their protocol contains many assumptions, and it needs to be validated by a prospective trial. Then the protocol should be tested in other surgical settings and in other institutions and compared with existing algorithms." Periodic reevaluation is important, since improvements in surgical technique may modify the blood requirement or obviate need entirely. Efforts to apply controlled studies to make more efficient use of predonations and limit donor risk are clearly a good thing. Some observers fear that reduced collections reflect less concern with risk-benefit and rational use than with the rising costs of autologous units in a cost-driven medical economy. Autologous collections are more costly since they require more professional time, special handling, labeling, storage, and inventory management. Reimbursement is notoriously insufficient, especially if the autologous unit is not transfused. Arguments based on costeffectiveness point at costs ranging from $235,000 to over $23 million per patient quality -adjusted life-year." If these are accurate, the increased protection afforded by autologous blood comes at a steep price. There is a final lesson for physicians to remember from the experience with transfusion-transmitted HIY. While our current safety net seems effective against known infectious risks, a newly emerging blood-transmitted agent with a long incubation period or interval of silent infection would not likely be prevented by all the precautions now in place. The chance that such an agent might emerge is small but finite, and it is the patient's perception of risk, not that of the physician, the health insurer, or the framer of health policy, that we must balance against statistics involving death, disability, and dollars. Studies show that people tend to overestimate "dread risks" (those over which they have no control and that have catastrophic consequences) and "unknown risks.'?" Such concerns may not be sufficient reason to return
Editorial
7
to the irrational and costly overcollection of autologous blood. However, some patients will inevitably demand this expensive insurance against the most remote possibility. Perhaps those who wish additional insurance should be charged an additional private premium. Harvey G. Klein, MD Warren G. Magnuson Clinical Center National Institutes of Health Bethesda, Md REFERENCES 1. 2. 3.
4. 5.
6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18.
19. 20. 21. 22.
Toy PT, Strauss RG. Stehling LC, et al. Predeposited autologous blood for elective surgery: a national multicenter study. N Engl J Med. 1987;316:517-520. Paul Gann Blood Safety Act, §1645 of the California Health and Safety Code, effective January I, 1990. Alter HJ, Reesink HW, Nishioka K. New trends in blood banking. In: IX Triennial International Symposium on Viral Hepatitis and Liver Disease, Rome, Italy. Turin, Italy: Edzioni Minerva Medica; 1997:358-362. Schrieber GB, Busch MP, Kleinman SH, Korelitz Ll, Retrovirus Epidemiology Donor Study. The risk of transfusion-transmitted viral infections. N EnglJ Med. 1996;334:1685-1690. Busch MP, Young MJ, Samson SM, Mosley JW, Ward JW, PerkinsHA, Transfusion Safety Study Group. Risk of human immunodeficiency virus (HlV) transmission by blood transfusions before the implementation of HlV-I antibody screening. Transfusion. 1991;31:4-11. Centers for Disease Control and Prevention. Table 5: AIDS cases by age group, exposure category, and sex. HIVIAIDS Surveill Rep. 1999;11(1): 12. Busch M, Chamberland M, Epstein J, Kleinman S, Khabbaz R, Nemo G. Oversight and monitoring of blood safety in the United States. Vox Sang. 1999;77:67-76. Klein HG. Allogeneic transfusion risks in the surgical patient. Am J Surg. 1995;170(suppI6A):21-26. Klein HG. Immunomodulatory aspects of transfusion: a once and future risk? Anesthesiology. 1999;91:861-865. Linden JV, Paul B, Dressler KP. A report of 104 transfusion errors in New York State. Transfusion. 1992;32:601-606. Goldman M, Remy-Prince S, Trepanier A, Decary F. Autologous donation error rates in Canada. Transfusion. 1997;37:523-527. Linden JV, Kruskall MS. Autologous blood: always safer? [editorial]. Transfusion. 1997;37:455-456. Klein HG, Dodd RY, Ness PM, Fratantoni JA, Nemo GJ. Current status of microbial contamination of blood components: summary of a conference. Transfusion. 1997;37:95-101. Popovsky MA, Whitaker B, Arnold NL. Severe outcomes of allogeneic and autologous blood donations: frequency and characterization. Transfusion. 1995;35:734-737. AuBuchon JP, Popovsky MA. The safety of preoperative autologous blood donation in the nonhospital setting. Transfusion. 1991;31:513-517. Spiess BD, Sassetti R, McCarthy RJ, Narbone RF, Tuman KJ, Ivankovich AD. Autologous blood donation: hemodynamics in a high-risk patient population. Transfusion. 1992;32: 17-22. National Blood Donor Resource Center. Report on Blood Collection and Transfusion in the United States in 1997. Bethesda, Md: National Blood Donor Resource Center; 1999. Nuttall GA, Santrach PJ, Oliver WC Jr, et al. Possible guidelines for autologous red blood cell donations before total hip arthroplasty based on the surgical blood order equation. Mayo Clin Proc. 2000;75:10-17. Axelrod FB, Pepkowitz SH, Goldfinger D. Establishment of a schedule of optimal preoperative collection of autologous blood. Transfusion. 1989;29:677-680. Birkmeyer JD, AuBuchon JP, Littenberg B, et al. Cost-effectiveness of preoperative autologous donation in coronary artery bypass grafting. Ann Thorac Surg. 1994;57: 161-168. Etchason J, Petz L, Keller E, et al. The cost effectiveness of preoperative autologous blood. N EnglJ Med. 1995;332:719-724. Slovic P. Perception of risk. Science. 1987;236:280-285.
For personal use. Mass reproduce only with permission from Mayo Clinic Proceedings.