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Biomedical subjects

J D Birkmeyer

Publications and source records attributed to J D Birkmeyer.

At least 19 recordsLinked to original sources

Cost-effectiveness of carotid endarterectomy in asymptomatic patients.

PURPOSE: The purpose of this study was to determine the cost-effectiveness of carotid endarterectomy for treating asymptomatic patients with > or = 60% internal carotid stenosis, based on outcomes reported in the Asymptomatic Carotid Atherosclerosis Study (ACAS). METHODS: A cost-effectiveness analysis was performed using a Markov decision model in which the probabilities for base-case analysis (average age, 67 years; 66% male; perioperative stroke plus death rate, 2.3%; ipsilateral stroke rate during medical management, 2.3% per year) were based on ACAS. The model assumed that patients who had TIAs or minor strokes during medical management crossed over to surgical treatment, and used the NASCET data to model the outcome of these now-symptomatic patients. Average cost of surgery ($8500), major stroke ($34,000 plus $18,000 per year), and other costs were based on local cost determinations plus a review of the published literature. Cost-effectiveness was calculated as the incremental cost of surgery per quality-adjusted life year (QALY) saved when compared with medical treatment, discounting at 5% per year. Sensitivity analysis was performed to determine the impact of key variables on cost-effectiveness. RESULTS: In the base-case analysis, surgical treatment improved quality-adjusted life expectancy from 7.87 to 8.12 QALYs, at an incremental lifetime cost of $2041. This yielded an incremental cost-effectiveness ratio of $8,000 per QALY saved by surgical compared with medical treatment. The high cost of care after major stroke during medical management largely offset the initial cost of endarterectomy in the surgical group. Furthermore, 26% of medically managed patients eventually underwent endarterectomy because of symptom development, which also decreased the cost differential. Sensitivity analysis demonstrated that the relative cost of surgical treatment increased substantially with increasing age, increasing perioperative stroke rate, and decreasing stroke rate during medical management. CONCLUSION: For the typical asymptomatic patient in ACAS with > or = 60% carotid stenosis, our results indicate that carotid endarterectomy is cost-effective when compared with other commonly accepted health care practices. Surgery does not appear cost-effective in very elderly patients, in settings where the operative stroke risk is high, or in patients with very low stroke risk without surgery.

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Cost-effectiveness of expanded human immunodeficiency virus-testing protocols for donated blood.

BACKGROUND: This study was designed to estimate the cost-effectiveness of expanding the human immunodeficiency virus (HIV)-testing protocol for donated blood beyond screening for HIV antibodies to further reduce the risk of HIV transmission through transfusion. STUDY DESIGN AND METHODS: A Markov decision analysis model was developed to estimate the cost-effectiveness of HIV antibody testing (at a cost of $5/unit) and of adding to that protocol a second HIV test, either plasma p24 antigen detection or RNA polymerase chain reaction (PCR) (at costs of $5/unit and $8/unit, respectively). Test efficacy was projected from anticipated window-period reductions (6 days for p24 antigen, 11 days for RNA PCR), and donor seroconversion rates were derived from the Retrovirus Epidemiology Donor Study. RESULTS: On the basis of current estimates of HIV prevalence rates in blood donors (1/10,000) and 16 million annual transfusions in the United States HIV antibody testing prevents 1568 cases of transfusion-acquired HIV infection each year at a cost of $3600 per quality-adjusted year of life saved. The addition of p24 antigen testing would prevent 8 more cases at a net additional cost of $60 million annually ($2.3 million/quality-adjusted life year); RNA PCR testing would prevent 16 more cases at a net additional cost of $96 million annually ($2.0 million/ quality-adjusted life year). CONCLUSION: Although expanding the donor HIV screening protocol with p24 antigen or RNA PCR testing will prevent rare cases of transfusion-associated HIV, the cost-effectiveness of such an addition is predicted to be far below that of most medical interventions. Thus, HIV test protocol additions are unlikely to provide cost-effective improvements to blood safety in the United States.

Blood Donors

A reader's guide to surgical decision analysis.

BACKGROUND: Studies using decision analysis appear increasingly often in the surgical literature. Because readers and reviewers may be unfamiliar with decision analysis, we review the technique and provide guidance on its interpretation. STUDY DESIGN: Review article. RESULTS: Decision analysis is a systematic approach to structuring a decision, collecting relevant information about the probability and relative value of outcomes, and making quantitative recommendations. Decision analysis includes the following basic components: (1) the decision model, (2) the probabilities of clinical outcomes in the model, (3) the utilities of clinical outcomes, and (4) the analysis and interpretation. To critically interpret the results of a decision analysis, readers must consider the validity of each component. The model should include all relevant clinical strategies and all important clinical outcomes. Probability estimates, whether derived from published studies or based on "clinical consensus," should be in general agreement with the reader's clinical experience. Utilities (values assigned to outcomes) are often expressed in terms of quality-adjusted life expectancy. Methods used to estimate life expectancy and to adjust for quality of life must be scrutinized carefully. Within the analysis, readers should consider the effect of varying uncertain variables in the model (sensitivity analysis) and, thus, the stability of the results. Finally, readers must assess whether the magnitude of expected benefit from the favored clinical strategy is clinically important. CONCLUSIONS: As decision analysis becomes more frequently used to influence clinical policy in surgery, surgeons must learn to examine the technique more critically.

Decision Support Techniques

A regional intervention to improve the hospital mortality associated with coronary artery bypass graft surgery. The Northern New England Cardiovascular Disease Study Group.

OBJECTIVE: To determine whether an organized intervention including data feedback, training in continuous quality improvement techniques, and site visits to other medical centers could improve the hospital mortality rates associated with coronary artery bypass graft (CABG) surgery. DESIGN: Regional intervention study. Patient demographic and historical data, body surface area, cardiac catheterization results, priority of surgery, comorbidity, and status at hospital discharge were collected on CABG patients in Northern New England between July 1, 1987, and July 31, 1993. SETTING: This study included all 23 cardiothoracic surgeons practicing in Maine, New Hampshire, and Vermont during the study period. PATIENTS: Data were collected on 15,095 consecutive patients undergoing isolated CABG procedures in Maine, New Hampshire and Vermont during the study period. INTERVENTIONS: A three-component intervention aimed at reducing CABG mortality was fielded in 1990 and 1991. The interventions included feedback of outcome data, training in continuous quality improvement techniques, and site visits to other medical centers. MAIN OUTCOME MEASURE: A comparison of the observed and expected hospital mortality rates during the postintervention period. RESULTS: During the postintervention period, we observed the outcomes for 6488 consecutive cases of CABG surgery. There were 74 fewer deaths than would have been expected. This 24% reduction in the hospital mortality rate was statistically significant (P = .001). This reduction in mortality rate was relatively consistent across patient subgroups and was temporally associated with the interventions. CONCLUSION: We conclude that a multi-institutional, regional model for the continuous improvement of surgical care is feasible and effective. This model may have applications in other settings.

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Effect of coronary artery diameter in patients undergoing coronary bypass surgery. Northern New England Cardiovascular Disease Study Group.

BACKGROUND: Coronary artery diameter is known to be inversely associated with perioperative mortality related to coronary artery bypass grafting (CABG). This association is believed to be responsible for increased risk among women and smaller people. However, the associations between sex, body size, and coronary size have not been carefully examined because direct information about coronary size is rarely available. Also, whether sex has an independent effect on vessel size is largely unknown. METHODS AND RESULTS: Height, weight, sex, age, status at hospital discharge, and luminal diameter of the midleft anterior descending coronary artery (mid-LAD) were recorded prospectively in 1325 patients undergoing CABG. Small vessel size was associated with substantially increased risk of in-hospital mortality (15.8% for 1.0-mm vessels, 4.6% for 1.5- to 2.0-mm vessels, and 1.5% for 2.5- to 3.5-mm vessels, P[trend] < .001). Vessel size was strongly related to both sex and measures of body size. In multiple linear regression analysis, vessel size was positively correlated with body surface area (P[trend] < .01), body mass index (P[trend] = .004), height (P[trend] = .001), and weight (P[trend] = .001). After controlling for differences in age and body size, sex remained an important predictor of coronary size. Within each quartile of each body-size measure, mid-LAD diameter in men was greater than that in women (mean difference [range], 0.14 to 0.23 mm). CONCLUSIONS: Small mid-LAD diameter is associated with substantially increased risk of in-hospital mortality with CABG. Although body size is correlated with mid-LAD diameter, women have smaller coronary arteries than men after controlling for differences in body size. These findings further support the hypothesis that smaller coronary arteries explain higher perioperative mortality with CABG in women and smaller people.

Body Constitution

The effect of peripheral vascular disease on long-term mortality after coronary artery bypass surgery. Northern New England Cardiovascular Disease Study Group.

OBJECTIVE: To examine the effect of peripheral vascular disease (PVD) on long-term mortality after successful myocardial revascularization. METHODS: We performed a regional cohort study of 2871 consecutive patients discharged alive after coronary artery bypass graft surgery at five tertiary care centers in Maine, New Hampshire, and Vermont between 1987 and 1989. Data reflecting patient characteristics, heart disease severity, and comorbidity were collected prospectively; the presence of clinical and subclinical indicators of PVD was determined by medical record review; and vital status was determined using the National Death Index (mean follow-up, 4.4 years). RESULTS: Five-year mortality following coronary artery bypass graft surgery was substantially higher in the 755 patients with indicators of PVD (20%; 95% confidence interval [CI], 17% to 23%) than in the 2116 patients without PVD (8%, 95% CI, 7 to 9; P<.001). The crude hazard ratio of long-term mortality associated with PVD was 2.77 (95% CI, 2.19 to 3.50; P<.001). After adjusting for their higher comorbidity scores, more advanced cardiac disease, and age, mortality rates in patients with PVD remained twice as high as those in patients without PVD (adjusted hazard ratio, 2.01; 95% CI, 1.57 to 2.58; P<.001). Long-term mortality was increased in patients with any of the indicators of PVD. Patients with multilevel PVD had especially high late mortality rates (adjusted hazard ratio, 2.46; 95% CI, 1.64 to 3.68; P<.001). CONCLUSIONS: Even after successful myocardial revascularization, patients with PVD remain at substantially increased risk for long-term mortality. The presence of clinical or subclinical PVD is important when predicting both short- and long-term outcomes in patients considering coronary artery bypass graft surgery.

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Decision analysis in surgery.

BACKGROUND: The technique of decision analysis is often applied to clinical policy and economic issues in surgery. Because surgeons may be unfamiliar with such work, this article catalogues decision analysis studies in the surgical specialties. METHODS: We reviewed the medical literature (1966 to 1994) to identify surgical decision analysis studies and to assess trends over time. Each article was categorized according to the type of journal (surgical, other clinical, or technical) in which it was published and content, including surgical specialty, clinical topic, article focus (individual patient decision making, clinical policy, or cost-effectiveness), and primary findings. RESULTS: Publication rates of surgical decision analysis have increased dramatically over time. Of the 86 total studies only six were published before 1980. In contrast, 44 studies appeared between 1990 and 1994. Although 77% were published in nonsurgical journals, decision analyses have begun to appear more regularly in surgical forums. Studies addressing all of the surgical specialties were found, although more than one half addressed topics in general surgery (34%) or cardiothoracic surgery (22%). The most frequent topics were gallstones (11 articles), head and neck cancer (five articles), coronary artery disease (four articles), and cerebral arteriovenous malformations (four articles). Articles focusing on clinical policy (i.e., those assessing surgical efficacy for broad groups of patients) now account for large majority of published decision analyses. CONCLUSIONS: The use of decision analysis in surgery is growing steadily. Because decision analysis is being used to influence clinical policy, it is important for surgeons to be aware of these studies and to be able to review them critically.

Decision Support Techniques

Use of inferior vena cava filters in the Medicare population.

To examine the use of inferior vena cava (IVC) filters, we performed a population-based study using a 5% random sample of the United States Medicare population (1.25 million persons). Filter placement and its timing relative to diagnosis of venous thromboembolism (VTE) were determined using both hospital and physician Medicare billing codes after detailed review of large samples of complete individual claims records. Comorbid conditions and mortality were also noted. From July 1986 through June 1989, a total of 806 patients in the sample population received IVC filters. Mortality rates after filter placement were high: 16% during initial hospitalization, 32% within 6 months of filter placement, and 48% after 2 years. However, only 3 (1%) of 423 patients who underwent filter placement without the diagnosis of pulmonary embolism (PE) suffered PE within 1 year of filter placement. Use of IVC filters increased significantly over the study period (p < 0.001). Rates of filter placement among the nine census divisions of the United States differed significantly (p < 0.001). An East-West trend was notable with the highest rate (37 filters/100,000 enrollees/yr) in New England, as compared with 14 filters/100,000 enrollees/yr in the Pacific Division. No explanation for these regional differences was evident after patient demographics and comorbidity were examined. Vena cava filters prevent PE for at least 1 year after placement. The frequency of IVC filter use in elderly patients is increasing and varies substantially by region. Although reasons for these trends are unclear, these findings suggest the need for uniform practice guidelines for IVC filter placement.

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The effect of peripheral vascular disease on in-hospital mortality rates with coronary artery bypass surgery. Northern New England Cardiovascular Disease Study Group.

PURPOSE: The purpose of this study was to examine the effect of peripheral vascular disease (PVD) on in-hospital mortality rates after coronary artery bypass grafting (CABG). METHODS: We performed a regional cohort study of 3003 patients undergoing CABG between 1987 and 1989 at five tertiary care centers in Maine, New Hampshire, and Vermont. Data reflecting patient characteristics, severity of heart disease, comorbidity, and in-hospital mortality rates were collected prospectively; the presence of clinical and subclinical indicators of PVD was determined retrospectively. RESULTS: Observed in-hospital mortality rates with CABG were 2.4-fold higher in the 796 patients with indicators of PVD (7.7%) than in the 2207 patients without PVD (3.2%) (crude odds ratio [OR] 2.42 [95% confidence interval (CI) 1.73-3.37]). After adjusting for their higher comorbidity scores, more advanced heart disease, and age, patients with PVD remained 73% more likely to die in hospital after CABG (adjusted OR 1.73 [CI 1.19-2.51]). The excess risk of in-hospital death associated with PVD was attributable largely to lower extremity occlusive disease (adjusted OR 2.03 [CI 1.34-3.07]). Subclinical lower extremity occlusive disease (asymptomatic absence of pedal pulses) had the same effect as clinically overt disease. Cerebrovascular disease had a small and statistically nonsignificant effect on CABG-related deaths (adjusted OR 1.13 [CI 0.73-1.74]). Excess mortality rates in patients with PVD were primarily due to increased risk of death from heart failure and dysrhythmias, but not to cerebrovascular accidents or peripheral arterial complications. CONCLUSIONS: The presence of lower extremity arterial occlusive disease is an important, independent predictor of in-hospital mortality rates for patients undergoing CABG. Controlled studies of the long-term effects of CABG in patients with PVD are needed to determine the optimal role of myocardial revascularization in this population.

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Acute normovolemic hemodilution is a cost-effective alternative to preoperative autologous blood donation by patients undergoing radical retropubic prostatectomy.

BACKGROUND: Preoperative autologous blood donation is accepted as a standard of care for radical prostatectomy. Acute normovolemic hemodilution (ANH) is an alternative method for obtaining autologous blood. The cost and benefits of these two autologous blood-collection techniques are compared. STUDY DESIGN AND METHODS: Thirty consecutive patients scheduled for radical prostatectomy underwent ANH to a target hematocrit level of 28 percent. Blood was transfused in the perioperative period to maintain the hematocrit level > 25 percent. Hematocrit levels, transfusion outcomes and costs, and postoperative outcomes for these patients (hemodilution group) were compared with a matched patient cohort who preoperatively donated 3 units of blood for autologous use in prostatectomy surgery (nonhemodilution group, n = 30). RESULTS: Thirty patients underwent ANH to a hematocrit level of 28.7 +/- 1.7 percent, and 1740 +/- 346 mL (3.5 +/- 0.7 units) of blood were collected. Three (10%) of the patients in each cohort had allogeneic blood exposure. Transfusion costs were 73 percent higher for the nonhemodilution group patients than for the hemodilution group patients ($330 +/- $100 vs. $191 +/- $55, p < 0.001). No differences were found in postoperative outcomes. CONCLUSION: An integrated blood conservation program utilizing hemodilution and a defined transfusion trigger can decrease the requirement for preoperative donation of blood for autologous use in radical prostatectomy. Point-of-care autologous blood procurement is more cost-effective than preadmission donation of autologous blood units.

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Cost-effectiveness of head CT in patients with lung cancer without clinical evidence of metastases.

OBJECTIVE: To estimate the cost-effectiveness of CT for detecting brain lesions in patients with lung cancer without clinical evidence of metastases. DESIGN: Decision analysis model comparing two different strategies for detecting brain metastases: brain CT routinely (CT-first) or brain CT only when patients develop neurologic signs and/or symptoms (CT-deferred). PATIENTS: Hypothetical cohort of patients with lung cancer with an unremarkable screening clinical evaluation for metastases. MEASUREMENTS: Net costs are calculated as the difference in costs between the two limbs of the decision tree. Net benefits are expressed as the difference in calculated years of life expectancy between the two strategies. Net costs are divided by net benefits, yielding the marginal cost per quality adjusted year of added life expectancy (C/QALY) for the CT-first strategy. RESULTS: In the baseline analysis, the C/QALY for the CT-first strategy is about $70,000. Improving the clinical evaluation as a screen for detecting brain metastases markedly increases the C/QALY. Increasing the cost of brain CT magnifies this effect. More effective treatment for asymptomatic brain metastases and better accuracy of CT for identifying resectable and unresectable brain metastases lower C/QALY. CONCLUSIONS: Although a threshold cost-effectiveness has not been defined for identifying "cost-effective" diagnostic procedures, the marginal C/QALY of the CT-first strategy is substantially higher than many accepted medical interventions. At current costs, the routine use of brain CT is not warranted in patients with lung cancer who have normal findings on a standardized clinical evaluation for metastases.

Brain Neoplasms

Safety and cost-effectiveness of solvent-detergent-treated plasma. In search of a zero-risk blood supply.

OBJECTIVE: To determine the public health and economic implications of solvent-detergent-treated frozen plasma (SD FP). While this processing technique nearly eliminates the risk of transmitting lipid-enveloped viruses (hepatitis B and C and human immunodeficiency virus), it has associated costs and, because it requires pooling many plasma units, may increase risks of nonenveloped virus transmission. DESIGN: A previously published Markov decision analysis model was modified to assess transfusion-related outcomes in hypothetical cohorts of plasma recipients. In-hospital mortality and other characteristics were determined in 61 patients receiving plasma transfusions at a medium-sized tertiary care center to provide data for the model. Other parameters were obtained from the medical literature. MAIN OUTCOME MEASURES: Expected SD FP costs, benefits, and cost-effectiveness, assessed as cost per quality-adjusted life-year saved. RESULTS: Compared with untreated plasma, a unit of SD FP produces a net benefit of 35 minutes in quality-adjusted life expectancy at a cost of about $19. Extrapolated to the 2.2 million plasma units transfused annually in the United States, SD FP would save 147 quality-adjusted life-years at a cost of $42.5 million. The marginal cost-effectiveness, $289,300 per quality-adjusted life-year saved in the baseline analysis, was most sensitive to estimates of SD treatment cost and the clinical setting of plasma use. In sensitivity analysis, the net benefit of SD FP was negated by the existence of even a minute risk of nonenveloped virus infection. CONCLUSIONS: From a public health perspective, the relatively high costs and small benefits of reducing enveloped virus infection risks with SD FP (and the additional risks of noneveloped virus transmission) do not appear to justify widespread implementation of this new technology.

Blood Component Transfusion

The epidemiology of diagnosed pulmonary embolism and deep venous thrombosis in the elderly.

BACKGROUND: There are no studies that define the basic epidemiology of pulmonary embolism (PE) and deep venous thrombosis (DVT) in the elderly. This project was undertaken to provide that information. METHODS: We obtained all Medicare claims during the period 1986 through 1989 from a random 5% sample of US Medicare enrollees. By selecting codes used for diagnoses and treatment, we identified 7174 cases of PE and 8923 cases of DVT. These cohorts were analyzed to provide incidence by age, race, sex, and geographic location; frequency of invasive treatment; frequency of PE after treatment for DVT; frequency of recurrence of PE; and survival after diagnosis. RESULTS: Annual incidence rates per 1000 at age 65 to 69 years for PE and DVT were 1.3 and 1.8, respectively. Both rates increased steadily with age to 2.8 and 3.1 by age 85 to 89 years. For PE, women had lower rates than men (adjusted relative risk, 0.86; 95% confidence interval, 0.82 to 0.90), and blacks had higher rates than whites (adjusted relative risk, 1.25; 95% confidence interval, 1.15 to 1.36). For DVT, the associations with gender and race were weaker and in the opposite direction. Pulmonary embolectomy was done in 0.2% of cases of PE; interruption of the vena cava was done in 4.4% of cases of PE and in 2% of cases of DVT. Thrombectomy was done in 0.3% of all cases. Pulmonary embolism occurred in 1.7% of patients with DVT within 1 year of hospital discharge for initial treatment. The 1-year recurrence rate for PE was 8.0%. In-hospital mortality associated with PE and DVT was 21% and 3%, respectively. One-year mortality was 39% and 21%, respectively. CONCLUSIONS: Pulmonary embolism and DVT are common problems in the elderly. Both increase with age, but the effects of race and sex are small. Current treatment patterns appear to be effective in preventing both PE after DVT and recurrence of PE. Both are associated with substantial 1-year mortality, suggesting the need to understand the role of associated conditions as well as the indications for prophylaxis and the methods of treatment.

Black or African American

Managing chronic atrial fibrillation: a Markov decision analysis comparing warfarin, quinidine, and low-dose amiodarone.

OBJECTIVE: To compare the relative risks and benefits of several clinical strategies for managing patients with chronic atrial fibrillation. DESIGN: Five recent randomized controlled trials of warfarin in atrial fibrillation, 6 randomized controlled trials of quinidine, and 13 longitudinal studies of low-dose amiodarone were used. A MEDLINE search was also done (1966 to present). MEASUREMENTS: A Markov decision analysis model was used to assess outcomes in large, hypothetical cohorts of patients with atrial fibrillation followed from 65 to 70 years of age within four clinical strategies: 1) no treatment; 2) warfarin; 3) electrical cardioversion followed by quinidine to maintain normal sinus rhythm; and 4) electrical cardioversion followed by low-dose amiodarone. RESULTS: IN this hypothetical cohort, fewer patients had disabling events with amiodarone (1.4%) than with quinidine (1.8%), warfarin (2.6%), or no treatment (7.4%). Amiodarone appeared to be associated with the lowest 5-year mortality (13.6%) when compared with warfarin (14.4%), quinidine (15.2%), and no treatment (18.2%). In terms of quality-adjusted life-years, amiodarone had the highest expected value (4.75 years), followed by warfarin (4.72 years), quinidine (4.68 years), and no treatment (4.55 years). Amiodarone remained the preferred strategy using the most plausible scenarios of risks associated with atrial fibrillation. Choices among warfarin, quinidine, and no treatment depended on estimates of bleeding rates with warfarin, stroke rates after discontinuing warfarin, quinidine-related mortality, and the quality of life with warfarin. CONCLUSION: Cardioversion followed by low-dose amiodarone to maintain normal sinus rhythm appears to be a relatively safe and effective treatment for patients with chronic atrial fibrillation.

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Cost-effectiveness of preoperative autologous donation in coronary artery bypass grafting.

Concern about the safety of the allogeneic blood supply has made preoperative autologous blood donation (PAD) routine before major noncardiac operations. However, the costs and benefits of PAD in elective coronary artery bypass grafting (CABG) are not well established. We used decision analysis to (1) calculate the cost-effectiveness of PAD in CABG, expressed as cost per year of life saved, and (2) compare the health benefits of reducing allogeneic transfusions with the potential risks of autologous blood donation by patients with coronary artery disease. A prospective study of 18 institutions provided data on transfusion practice and blood product costs in CABG. On average, PAD in CABG costs $508,000 to $909,000 per quality-adjusted year of life saved, depending on the number of units donated. Preoperative autologous blood donation is more cost-effective (as low as $518,000 per year of life saved) when targeted to younger patients undergoing CABG at centers with high transfusion rates. The cost-effectiveness of PAD is strongly dependent on estimates of posttransfusion hepatitis incidence, but less so on plausible estimates of the current risk of human immunodeficiency virus transmission. Although the actual risk of PAD is uncertain, even a small fatality risk (> 1 per 101,000 donations) associated with blood donation by patients awaiting CABG negates all life expectancy benefits of PAD. At current costs, PAD by patients awaiting CABG is not cost-effective, producing small health benefits at high societal cost. For the individual patient, the risk of donating blood before CABG may well outweigh the benefits associated with fewer allogeneic transfusions.

Blood Transfusion, Autologous