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ORIGINAL RESEARCH |
From the Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Washington University Medical Center, St. Louis, Missouri.
Address reprint requests to: Thomas J. Herzog, MD, Washington University Medical Center, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, 4911 Barnes Jewish Hospital Plaza, St. Louis, MO 63110; E-mail: herzogt{at}msnotes.wustl.edu.
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ABSTRACT |
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METHODS: Pheresis unit records were retrospectively reviewed to identify all women who performed autologous blood donation. Clinical charts were abstracted. Use rate (number of units used/number of units donated) and quality-adjusted life years were calculated. Statistical analysis consisted of 
2, Student t, and Fisher exact tests.
RESULTS: A total of 106 women with benign (n = 63) and malignant disease (n = 43) donated 143 units (1.4 units per patient) of which 126 (88%) were discarded. Fifteen patients (14%) were transfused a total of 24 units, 17 autologous (71%) and seven allogeneic (29%). Those transfused had a significantly higher estimated blood loss (700 mL versus 275 mL, P < .001), lower nadir hemoglobin (7.9 versus 9.6, P < .001), and longer hospital stay (4.9 days versus 4.0 days, P = .05). Despite similar estimated blood loss (370 mL versus 310 mL), the use rate for malignant versus benign disease was significantly greater (0.31 versus 0.07, P = .005). Radical versus nonradical surgery had a significantly higher estimated blood loss (620 mL versus 250 mL, P = .001) and use rate (0.26 versus 0.11, P = .001) as well. Estimated cost per quality-adjusted life years for autologous blood donation for each category exceeded $1,000,000.
CONCLUSION: Autologous blood donation is an expensive medical practice and does not guarantee that exposure to allogeneic blood will not occur. If pursued, it should be directed towards those who have a known malignancy or those for whom radical surgery is anticipated. Other methods of blood conservation may be safer and more cost-effective.
Before the recognition that human immunodeficiency virus and hepatitis could be transmitted through blood transfusions, the use of preoperative autologous blood donation was rarely used. Over the past two decades, however, this practice has grown such that, in 1997, approximately one in every 20 units of blood collected in the United States was the result of an autologous donation.1 Although preoperative autologous blood donation and transfusion appears to be risk free for the individual patient, it is not without its adverse consequences2,3 or devoid of many of the same noninfectious complications seen with allogeneic blood.4 In addition, there are increased costs associated with autologous donations and transfusions. These costs arise from the additional screening required of autologous donors, a more in-depth processing of autologous units, and the disposal of unused units. Given these risks, costs, and the decreased likelihood of virus transmission with allogeneic blood, the cost-effectiveness of preoperative autologous blood donation has been questioned.5
The utility and cost-effectiveness of autologous blood donation has primarily been evaluated in urologic, orthopedic, and cardiovascular surgery.6–9 Very little information has been collected in the field of obstetrics and gynecology. Several authors have addressed the use of allogeneic and autologous transfusion practices in both general and gynecologic oncology procedures,10–12 whereas others have instituted programs to improve the success of autologous donation in gynecologic patients.13,14 However, only Etchason et al9 have analyzed the cost-effectiveness of preoperative autologous blood donation in benign gynecologic patients, specifically those undergoing total abdominal hysterectomy. Based on their results, Etchason et al9 concluded that the use of autologous blood in abdominal hysterectomy was not cost-effective. Whether this unfavorable analysis holds true in radical surgery for gynecologic malignancies has not been addressed. Drawing a parallel from radical prostatectomies, it appears that it may not.8
In an attempt to answer the question of whether or not preoperative autologous blood donation is cost-effective for gynecologic patients scheduled for radical or non-radical gynecologic procedures, we reviewed the use of preoperative autologous blood donation in our gynecologic and gynecologic oncology patients.
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MATERIALS AND METHODS |
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Clinical charts and blood bank records were reviewed, and data were collected including diagnosis; surgical procedure; estimated blood loss, number of units transfused; length of stay; and preoperative, nadir, and discharge hemoglobins. Use rate (number of units used per number of units donated) and cost-effectiveness were calculated. Cost-effectiveness was expressed as the cost per quality-adjusted life year (QALY) saved. The costs incorporated into this calculation included the direct expenditures associated with blood collection, processing and inventory, infectious disease testing, discarding unused units, and the predicted costs of treating transfusion-related complications. It does not reflect any indirect costs associated with wages or productivity lost as a result of an illness or death. Published estimates of the probabilities per unit of blood of experiencing a transfusion complication or contracting a transfusion-associated infection were used to calculate the cost-effectiveness.1 The actual cost-effectiveness was defined as follows:
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where Cdonor and Cnondonor are the transfusion-related costs for autologous donors and nondonors and QALYdonor and QALYnondonor are the QALYs for autologous donors and nondonors.
Statistical analysis consisted of 2, two-tailed Student t, and Fisher exact tests.
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RESULTS |
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). These 40 patients comprised the radical surgery group. The majority of patients with benign disease were referred to the gynecologic oncologist with the diagnosis of complex atypical hyperplasia with concern for endometrial carcinoma or a pelvic mass (n = 31). Of the remaining 32 patients with benign disease, 23 had complex pelvic reconstructive surgery for pelvic relaxation, whereas nine had surgeries for severe endometriosis or precancerous cervical lesions. These patients were considered to have had nonradical surgery.
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Fifteen patients (14%) received a blood transfusion with a total of 24 units being delivered, 17 autologous (71%) and seven allogeneic (29%). Transfusion of multiple units was required by six patients (40%) with the maximum of four units given to any one patient. The allogeneic units were given only after all the autologous units had been used. These allogeneic units were given to three patients, two with malignancies, and one with benign disease. The majority (n = 15) of the units were transfused postoperatively, whereas the other nine were given intraoperatively. No documented adverse reactions occurred with any of these transfusions. When compared with those patients who did not receive a blood transfusion, these 15 patients had similar preoperative hemoglobins but significantly higher estimated blood losses, lower nadir hemoglobins, and longer hospital stays (Table 2).
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). Use rate within the study population also differed significantly based on the surgical procedure performed. Patients undergoing a radical hysterectomy or radical tumor debulking had a significantly higher estimated blood loss (620 mL versus 250 mL, P = .001) and a significantly higher use rate, (0.26 versus 0.11, P = .001) than those who had a nonradical procedure (Table 3). Those patients with cervical cancer who underwent a radical hysterectomy donated more autologous blood than any other group of patients having radical surgery. Although their use rate approached statistical significance, it did not achieve it (0.36 versus 0.14, P = .15).
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). Similar costs per QALY were calculated for preoperative autologous blood donation in patients with a diagnosis of a malignancy, $1,141,176, and for benign disease, $5,048,327 (Table 3). |
DISCUSSION |
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In general, blood transfusion was not a common occurrence in our gynecologic or gynecologic oncology patient population with only 14% of patients receiving a blood transfusion. Despite a similar estimated blood loss, those patients with a malignancy had a significantly greater use rate than those with benign disease. This was particularly true for those patients with cervical cancer who underwent radical hysterectomy. The transfusion rate for this group of patients was approximately 30%. Given the theoretic consequences of tumor hypoxia15and given the newer evidence that survival may be improved with higher hemoglobins,16,17 it is likely that attending gynecologic oncologists had a lower threshold for transfusion in those patients with malignant disease, thus potentially biasing the use rate in this patient group. Although the rate of transfusion in our cervical cancer patients was substantial, it was slightly lower than the 40–50% rate of transfusion reported in the literature.11,18 Reasons for this lower rate are unclear. Unfortunately, we did not evaluate the impact of our low transfusion rate on postoperative infections or the relationship of hemoglobin level and response to adjuvant therapy; however, this lower rate of transfusion did not adversely affect postoperative recovery as measured by similar lengths of stay.
The cost per QALY for autologous blood donation calculated for our patients with a malignancy or who underwent a radical surgical procedure was well above the $50,000–$100,000 per QALY threshold of commonly accepted medical and surgical interventions (Table 4) (see also www.hsph.harvard.edu/organizations/hcra/cuadatabase/into.html). Much of the additional cost associated with autologous blood in our study was a consequence of the poor use rate of the donated autologous units. Eighty-eight percent of all the autologous units donated in our study went unused. On average, only 15–30% of autologous donors and the units that they supply meet the strict screening criteria applied to volunteers donating allogeneic units.19,20 As a result, the majority of unused autologous units cannot be reallocated to the universal blood supply available to society, and therefore, they must be destroyed. The cost of discarding and destroying this large excess of units clearly contributed to the poor cost-effectiveness seen in our study. If these unused autologous units could be transfused to nondonor recipients rather than simply being destroyed, then the cost-effectiveness of autologous donation would improve. However, even if 50% of unused autologous units were added to the allogeneic supply, the cost per QALY of autologous blood donation in this investigation would still be approximately $250,000 for those with a malignancy or who underwent radical surgery. Although it may be feasible to develop these crossover programs, the costs of maintaining such a program and the potential risk of error may be prohibitively high.21
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Although we failed to detect any iatrogenic anemia caused by the donation of autologous blood, other authors have noted that decreasing the hemoglobin preoperatively with autologous donation most likely results in an increased transfusion rate in most patients who donate autologous blood. In addition, when autologous units are available, many physicians may adapt a more liberal transfusion policy.10 Considering that autologous transfusions still carry unavoidable risks such as hemolytic reactions, volume overload, and bacterial contamination, the potential increase in number of total transfusions related to autologous units may outweigh any benefits gained by avoiding transfusion-related infectious complications seen with allogeneic blood.
The calculation of the cost-effectiveness of autologous blood donation incorporates many variables and predicted probabilities of transfusion-related complications. By changing any number of these variables (ie, amount of compatibility testing or level of infectious disease screening) or by adjusting the probabilities (ie, rate of human immunodeficiency virus or hepatitis transmission), one could potentially change the cost-effectiveness. Although we did not hypothetically adjust any of these parameters and recalculate our cost per QALY, Etchason et al9 did and noted only modest improvements in the cost-effectiveness for total abdominal hysterectomy. Extrapolating from their data, one must assume that similar adjustments in our patient population would have had little impact on the cost-effectiveness.
As a result of the high cost of preoperative autologous blood transfusion, other blood conservation methods have been developed. One such method, acute normovolemic hemodilution, has been shown to be equivalent to autologous blood donation in decreasing the use of allogeneic blood while providing additional benefits.22–24 Acute normovolemic hemodilution involves removing whole blood from the patient immediately before surgery and simultaneously replacing it with colloid or crystalloid to maintain a constant circulatory volume. By doing so, the blood lost during surgery is more dilute, resulting in a smaller net loss of red cells. During surgery, after any major blood loss, the blood can be reinfused. Although there are limits as to who is a potential candidate for acute normovolemic hemodilution, there are several benefits when compared with autologous blood donation. Elimination of testing, storage, and administrative errors decrease the costs and increase the safety of hemodilution. Given these promising data, further studies are indicated; however, as the safety of allogenic transfusions continue to improve, it may be difficult to justify the use of alternative blood conservation methods in any situation other than when allogeneic units are unavailable.
Despite the diagnosis of a malignancy and despite radical surgery, the cost-effectiveness of preoperative autologous blood donation is poor and must be critically examined. Because of the inherent reassurance gained by patients when they donate autologous blood, this intervention will continue to be available. Whether the extra financial burden to the health care system associated with autologous blood donation is covered by the patients or by third-party payers remains to be seen. In the meantime, while we continue to develop and evaluate alternative blood conservation methods, we must optimize the potential of autologous blood donation by ensuring that the appropriate patient populations donate the appropriate amount of autologous units.
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Footnotes |
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Received August 3, 2001. Received in revised form December 10, 2001. Accepted January 10, 2002.
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REFERENCES |
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2. Aubuchon JP, Popovsky MA. The safety of preoperative autologous blood donation in the non-hospital setting. Transfusion 1991;31:513–7.[Medline]
3. Mann M, Sacks HT, Goldfinger D. Safety of autologous blood donation prior to elective surgery for a variety of potentially "high risk" patients. Transfusion 1983;235: 229–32.
4. Goodnough LT, Brecher ME, Kanter MH, AuBuchon JP. Transfusion medicine. Second of two parts. Blood conservation. N Engl J Med 1999;340:525–33.
5. Goldfinger D, Haimowitz M, AuBuchon JP, Birkmeyer JD. Controversies in transfusion medicine: Is autologous blood transfusion worth the cost? Pro and con. Transfusion 1994;34:75–83.[Medline]
6. Birkmeyer JD, Goodnough LT, AuBuchon JP, Noordsu PG, Littenberg B. The cost-effectiveness of preoperative autologous blood donation for total hip and knee replacement. Transfusion 1993;33:544–51.[Medline]
7. Marchetti M, Barosi G. Cost-effectiveness of epoetin and autologous blood donation in reducing allogeneic blood transfusions in coronary artery bypass graft surgery. Transfusion 2000;40:673–81.[Medline]
8. Goodnough LM, Grishaber JE, Birkmeyer JD, Monk TG, Catalona WJ. Efficacy and cost-effectiveness of autologous blood predeposit in patients undergoing radical prostatectomy procedures. Urology 1994;44:226–31.[Medline]
9. Etchason J, Petz L, Keeler E, Calhoun L, Kleinman S, Snider C, et al. The cost effectiveness of preoperative autologous blood donations. N Engl J Med 1995;332: 719–24.
10. Kanter MH, van Maanen D, Anders KH, Castro F, Win Maya W, Clark K. Preoperative autologous blood donations before elective hysterectomy. JAMA 1996;276: 798–801.[Abstract]
11. Benjamin I, Barakat RR, Curtin JP, Jones WB, Lewis JL, Hoskins WJ. Blood transfusion for radical hysterectomy before and after the discovery of transfusion-related human immunodeficiency virus infection. Obstet Gynecol 1994;84:974–8.
12. Wang C, Lau W, Herst R, Drutz H, Fernandes B. Preoperative autologous blood deposition in support of gynaecological repair procedures. Transfus Med 1998;8:23–7.[Medline]
13. Gargano G, Fanizza G, Polignano G, Lorusso V, De Lena M. A new protocol of iron therapy combined with epoetin alpha as a treatment for preoperative autologous blood donation in gynaecological tumor surgery. Oncol Rep 1999;6:1349–52.[Medline]
14. Kanter MH, van Maanen D, Anders KH, Castro F, Win Mya W, Clark K. A study of an educational intervention to decrease inappropriate preoperative autologous blood donation: Its effectiveness and the effect on subsequent transfusion rates in elective hysterectomy. Transfusion 1999;39:801–7.[Medline]
15. Hockal M, Vaupal P. Biologic consequences of tumor hypoxia. Semin Oncol 2001;2(Suppl. 8):36–41.
16. Obermair A, Chek R, Horwood K, Janda M, Bachtiary B, Schwanzelberger B, et al. Impact of hemoglobin levels before and during concurrent chemoradiotherapy on the response of treatment in patients with cervical carcinoma: Preliminary results. Cancer 2001;92:903–8.[Medline]
17. Grogan M, Thomas GM, Melamed I, Wong FL, Pearcy RG, Joseph PK, et al. The importance of hemoglobin levels during radiotherapy for carcinoma of the cervix. Cancer 1999;86:1528–36.[Medline]
18. Monk BJ, Tewari K, Gamboa-Vujicic G, Burger RA, Manetta A, Berman ML. Does perioperative blood transfusion affect survival in patients with cervical cancer treated with radical hysterectomy. Obstet Gynecol 1995; 85:343–8.[Abstract]
19. Kruskall MS, Yomtovian R, Dzik WH, Friedman KD, Umlas J. On improving the cost effectiveness of autologous blood transfusion practices. Transfusion 1994;34: 259–64.[Medline]
20. Renner SW, Howanitz PJ, Bachner P. Preoperative autologous blood donation in 612 hospitals: A College of American Pathologists’ Q-probes study of quality issues in transfusion practice. Arch Pathol Lab Med 1992;116:613–9.[Medline]
21. Blum LN, Allen JR, Genel M, Howe JP III. Crossover use of donated blood for autologous transfusions: Report of the Council on Scientific Affairs, American Medical Association. Transfusion 1998;38:891–5.[Medline]
22. Rosenblatt MA, Cantos EM, Mohandas K. Intraoperative hemodilution is more cost-effective than preoperative autologous donation for patients undergoing procedures associated with a low risk for transfusion. Clin Anesth 1997;9:26–9.
23. Goodnough LT, Monk TG, Brecher ME. Acute normovolemic hemodilution in surgery. Hematology 1997;2: 413–20.
24. Ness PM, Bourke DL, Walsh PC. A randomized trial of perioperative hemodilution versus transfusion of preoperatively deposited autologous blood in elective surgery. Transfusion 1992;32:226–30.[Medline]
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