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Mortality rates following carotid endarterectomy (CEA) may be much higher in routine practice than the rates seen in two clinical trials of CEA. The NASCET trial achieved a post-operative death rate of 0.6% and that in the ACAS trial was 0.1%. Researchers analyzed post-operative death rates in 113,300 Medicare patients who had CEA. Some had the procedure in the same hospitals that participated in the trials. The overall mortality rate was 1.4% in the trial hospitals and from 1.7% to 2.5% in non-trial hospitals, depending on how many CEAs the surgeons performed. Hospitals that performed fewer CEAs had higher mortality rates., Context.--The North American Symptomatic Carotid Endarterectomy Trial (NASCET) and the Asymptomatic Carotid Atherosclerosis Study (ACAS) demonstrated the efficacy of carotid endarterectomy (CEA) in reducing the risk of stroke and death in selected patents when surgery was performed in institutions whose participation depended on demonstrated excellence. Thirty-day mortality rates in the trials were very low: 0.6% in NASCET and 0.1% in ACAS. Objective.--To assess perioperative mortality among Medicare patients undergoing CEA in all nonfederal institutional settings. Design.--Retrospective national cohort study. Setting and Patients.--All 113 300 Medicare patients undergoing CEA during 1992 and 1993 in "trial hospitals" (those participating in NASCET and ACAS, n=86) and "nontrial hospitals" (all other nonfederal institutions performing CEAs, n=2613). Nontrial hospitals were stratified into terciles based on volume of CEAs performed. Main Outcome Measures.--Crude and adjusted perioperative (30 day) mortality rates. Results.--The perioperative mortality rate was 1.4% (95% confidence interval [CI], 1.2%-1.7%) at trial hospitals; mortality in nontrial hospitals was higher: 1.7% (95% CI, 1.6%-1.8%) (high volume); 1.9% (95% CI, 1.7%-2.1%) (average volume); 2.5% (95% CI, 2.0%-2.9%) (low volume); (P for trend, [is less than] .001). In multivariate modeling, patients undergoing their procedures at trial hospitals had a mortality risk reduction of 15% (95% CI, 0%-31%) compared with high-volume nontrial hospitals, 25% (95% CI, 7%-40%) compared with average-volume hospitals, and 43% (950/0 CI, 25%-56%) compared with low-volume hospitals (P for trend, [is less than] .001). Conclusion.--Medicare patients' perioperative mortality following CEA is substantially higher than that reported in the trials, even in those institutions that participated in the randomized studies. Caution is advised in translating the efficacy of carefully controlled studies of CEA to effectiveness in everyday practice. JAMA 1998;279:1278-1281

A continuous quality improvement program could reduce mortality rates from coronary artery bypass graft (CABG) surgery. Researchers affiliated with the Northern New England Cardiovascular Disease Study Group implemented a program to give cardiovascular surgeons regular feedback on patient outcomes, teach them the principles of continuous quality improvement and encourage them to visit other sites. Twenty-three cardiovascular surgeons at five medical centers in Maine, New Hampshire and Vermont participated. Mortality rates among the 15,095 patients undergoing CABG surgery dropped 24% in the 27-month period following the implementation of the program between July, 1990 and April 1991. The reductions occurred in every hospital except the one with the lowest mortality rates at the start of the study. Male and female patients alike benefitted from the program., 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. (JAMA. 1996;275:841-846)

The safety benefits of solvent-detergent-treated frozen plasma (SD FP) seem to be outweighed by the costs. SD FP is a technique that purifies multiple units of blood plasma with a SD mixture. This process eliminates envelope-covered viruses such as HIV and hepatitis. Researchers applied a decision analysis model to a large hypothetical group of plasma-transfused patients. The model approximated the predicted benefits and costs of SD FP. Results revealed that one unit of SD FP lengthened patients' lives by approximately 35 minutes. The cost incurred for each unit of SD FP was about $19.30. These cost-benefit estimates were applied to national plasma transfusion figures. For the 2.2 million plasma units that are transfused into U.S. patients each year, SD FP would save 147 years of life at a cost $42.5 million. The cost effectiveness of SD FP was estimated at $289,300 per year of life. SD FP creates an increased risk of transmitting a nonenveloped virus such as the hepatitis A virus., 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 nonenveloped virus transmission) do not appear to justify widespread implementation of this new technology.