Evaluation of risk in patients with chest pain presenting to the emergency department.
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Biomedical subjects
Publications and source records attributed to M A Hlatky.
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BACKGROUND: Patients who undergo coronary angioplasty have a shorter convalescence than those who undergo coronary bypass surgery. This may improve subsequent employment. OBJECTIVE: To compare employment patterns after coronary angioplasty or surgery. DESIGN: Multicenter, randomized clinical trial. SETTING: Seven tertiary care hospitals. PATIENTS: 409 employed patients with multivessel coronary artery disease. INTERVENTION: Coronary bypass surgery or balloon angioplasty. MEASUREMENTS: Time to return to work and time spent working during 4 years of follow-up. RESULTS: Patients who underwent angioplasty returned to work 6 weeks sooner than patients who underwent coronary bypass surgery (P < 0.001), but long-term employment did not differ significantly (P > 0.2). Long-term employment was significantly lower among patients who were 60 to 64 years of age (P < 0.001), those who worked less than full-time at study entry (P < 0.001), and those who had less formal education (P = 0.005). Patients with only one source of health insurance were more likely to continue working (P = 0.005). CONCLUSIONS: Faster recovery after angioplasty speeds return to work but does not improve long-term employment, which is primarily associated with nonmedical factors.
We defined the proportion of post-myocardial infarction patients who would have been eligible for the Multicenter Automatic Defibrillator Implantation Trial (MADIT) from a population of 94,797 patients with myocardial infarction entered into the Cardiac Arrhythmia Suppression Trial Registry. From this large population, only between 0.3% to 1.7% would have met strict eligibility criteria for MADIT.
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OBJECTIVES: The Veterans Affairs Non-Q-Wave Infarction Strategies In-Hospital (VANQWISH) trial was designed to compare outcomes of patients with a non-Q wave myocardial infarction (NQMI) who were randomized prospectively to an early "invasive" strategy versus an early "conservative" strategy. The primary objective was to compare early and late outcomes between the two strategies using a combined trial end point (all-cause mortality or nonfatal infarction) during at least 1 year of follow-up. BACKGROUND: Because of the widely held view that survivors of NQMI are at high risk for subsequent cardiac events, management of these patients has become more aggressive during the last decade. There is a paucity of data from controlled trials to support such an approach, however. METHODS: Appropriate patients with a new NQMI were randomized to an early "invasive" strategy (routine coronary angiography followed by myocardial revascularization, if feasible) versus an early "conservative" strategy (noninvasive, predischarge stress testing with planar thallium scintigraphy and radionuclide ventriculography), where the use of coronary angiography and myocardial revascularization was guided by the development of ischemia (clinical course or results of noninvasive tests, or both). RESULTS: A total of 920 patients were randomized (mean follow-up 23 months, range 12 to 44). The mean patient age was 61 +/- 10 years; 97% were male; 38% had ST segment depression at study entry; 30% had an anterior NQMI; 54% were hypertensive; 26% had diabetes requiring insulin; 43% were current smokers; 43% had a previous acute myocardial infarction; and 45% had antecedent angina within 3 weeks of the index NQMI. CONCLUSIONS: Baseline characteristics were compatible with a moderate to high risk group of patients with an NQMI.
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We developed a decision-support system for evaluation of treatment alternatives for supraventricular and ventricular arrhythmias. The system uses independent decision models that evaluate the costs and benefits of treatment for recurrent atrioventricular-node reentrant tachycardia (AVNRT), and of therapies to prevent sudden cardiac death (SCD) in patients at risk for life-threatening ventricular arrhythmias. Each of the decision models is accessible through a web-based interface that enables remote users to browse the model's underlying evidence and to perform analyses of effectiveness, cost effectiveness, and sensitivity to input variables. Because the web-based interface is independent of the models, we can extend the functionality of the system by adding decision models. This system illustrates that the use of a library of web-accessible decision models provides decision support economically to widely dispersed users.
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BACKGROUND: Some randomized clinical trials of amiodarone therapy to prevent sudden cardiac death have had positive results and others have had negative results, but all were relatively small. This meta-analysis aimed to pool all trials to assess the effect of amiodarone on mortality and the impact of differences in patient population and study design on trial outcomes. METHODS AND RESULTS: Fifteen randomized trials were identified, and outcome measures were combined by use of a random effects model. The effect of patient population and study design on total mortality was assessed by use of a hierarchical Bayes model. Amiodarone reduced total mortality by 19% (confidence limits, 6% to 31%; P<.01), with somewhat greater reductions in cardiac mortality (23%, P<.001) and sudden death (30%, P<.001). Mortality reductions were similar in trials enrolling patients after myocardial infarction (21%), with left ventricular dysfunction (22%), and after cardiac arrest (25%). There was a trend toward greater risk reduction in trials requiring evidence of ventricular ectopy (25%) than in the remaining trials (10%). The trials using placebo controls had considerably less risk reduction (10%) than trials with active controls (27%) or usual care controls (42%, posterior odds <0.02). CONCLUSIONS: Amiodarone reduced total mortality by 10% to 19% in patients at risk of sudden cardiac death. Amiodarone reduced risk similarly in patients after myocardial infarction, with heart failure, or with clinically evident arrhythmia. The apparent inconsistencies among results of randomized trials appear to be due to small sample sizes and the type of control group used, not the type of patient enrolled.
BACKGROUND: Coronary bypass surgery often leads to short-term cognitive dysfunction, whereas coronary angioplasty does not. Perioperative cognitive dysfunction usually resolves, although a subgroup of surgical patients may continue to exhibit long-term cognitive dysfunction. The purpose of this study was to compare cognitive function 5 years after randomization to a strategy of either initial coronary surgery or initial angioplasty. METHODS AND RESULTS: Five centers in the Bypass Angioplasty Revascularization Investigation participated in this ancillary study. Patients with multivessel coronary disease randomized to angioplasty or surgery were eligible at the time of their 5-year clinic visit. A battery of five measures previously shown to be sensitive to perioperative changes in cognitive function was administered, including the Logical and Figural Memory Scales from the Wechsler Memory Scale, the Digit Symbol and Digit Span subtests from the Wechsler Adult Intelligence Scale, and Part B of the Reitan Trail Making Test. The 125 study patients were generally similar to the 133 patients who were eligible but did not participate, although study participants were significantly younger (P=.003). The 64 patients randomly assigned to angioplasty had baseline characteristics similar to those of 61 patients randomly assigned to surgery. Cognitive function scores were not significantly different between angioplasty or surgery patients in an intention-to-treat analysis (P=.57). There also was no difference in cognitive function scores when the data were analyzed according to whether the patient had ever undergone bypass surgery (P=.59). CONCLUSIONS: Long-term cognitive function is similar after coronary bypass surgery and coronary angioplasty in the majority of patients.
BACKGROUND: Randomized trials comparing coronary angioplasty with bypass surgery in patients with multivessel coronary disease have shown no significant differences in overall rates of death and myocardial infarction. We compared quality of life, employment, and medical care costs during five years of follow-up among patients treated with angioplasty or bypass surgery. METHODS: A total of 934 of the 1829 patients enrolled in the randomized Bypass Angioplasty Revascularization Investigation participated in this study. Detailed data on quality of life were collected annually, and economic data were collected quarterly. RESULTS: During the first three years of follow-up, functional-status scores on the Duke Activity Status Index, which measures the ability to perform common activities of daily living, improved more in patients assigned to surgery than in those assigned to angioplasty (P<0.05). Other measures of quality of life improved equally in both groups throughout the follow-up period. Patients in the angioplasty group returned to work five weeks sooner than did patients in the surgery group (P<0.001). The initial mean cost of angioplasty was 65 percent that of surgery ($21,113 vs. $32,347, P<0.001), but after five years the total medical cost of angioplasty was 95 percent that of surgery ($56,225 vs. $58,889), a difference of $2,664 (P = 0.047). The five-year cost of angioplasty was significantly lower than that of surgery among patients with two-vessel disease ($52,930 vs. $58,498, P<0.05), but not among patients with three-vessel disease ($60,918 vs. $59,430). After five years of follow-up, surgery had an overall cost-effectiveness ratio of $26,117 per year of life added, but unacceptable ratios of $100,000 or more per year of life added could not be excluded (P=0.13). Surgery appeared particularly cost effective in treating diabetic patients because of their significantly improved survival. CONCLUSIONS: In patients with multivessel coronary disease, coronary-artery bypass surgery is associated with a better quality of life for three years than coronary angioplasty, after the initial morbidity caused by the procedure. Coronary angioplasty has a lower five-year cost than bypass surgery only in patients with two-vessel coronary disease.
BACKGROUND: Implantable cardioverter defibrillators (ICDs) are remarkably effective in terminating ventricular arrhythmias, but they are expensive and the extent to which they extend life is unknown. The marginal cost-effectiveness of ICDs relative to amiodarone has not been clearly established. OBJECTIVE: To compare the cost-effectiveness of a third-generation implantable ICD with that of empirical amiodarone treatment for preventing sudden cardiac death in patients at high or intermediate risk. DESIGN: A Markov model was used to evaluate health and economic outcomes of patients who received an ICD, amiodarone, or a sequential regimen that reserved ICD for patients who had an arrhythmia during amiodarone treatment. MEASUREMENTS: Life-years gained, quality-adjusted life-years gained, costs, and marginal cost-effectiveness. RESULTS: For the base-case analysis, it was assumed that treatment with an ICD would reduce the total mortality rate by 20% to 40% at 1 year compared with amiodarone and that the ICD generator would be replaced every 4 years. In high-risk patients, if an ICD reduces total mortality by 20%, patients who receive an ICD live for 4.18 quality-adjusted life-years and have a lifetime expenditure of $88,400. Patients receiving amiodarone live for 3.68 quality-adjusted life-years and have a lifetime expenditure of $51,000. Marginal cost-effectiveness of an ICD relative to amiodarone is $74,400 per quality-adjusted life-year saved. If an ICD reduces mortality by 40%, the cost-effectiveness of ICD use is $37,300 per quality-adjusted life-year saved. Both choice of therapy (an ICD or amiodarone) and the cost-effectiveness ratio are sensitive to assumptions about quality of life. CONCLUSIONS: Use of an ICD will cost more than $50,000 per quality-adjusted life-year gained unless it reduces all-cause mortality by 30% or more relative to amiodarone. Current evidence does not definitively support or exclude a benefit of this magnitude, but ongoing randomized trials have sufficient statistical power to do so.
In a large cohort of patients with known or suspected coronary disease, we evaluated the characteristics of 407 patients who died after hospital discharge and tested whether the state death certificate can be used to classify deaths as sudden cardiac versus nonsudden. Compared with a paramedic classification system based on heart rhythm, the death certificate-based classification resulted in a sensitivity that ranged from 78% to 85% and a specificity that ranged from 25% to 58%. We conclude that the death certificate can be used to identify cases of sudden cardiac death in patients at high risk; however, there is a substantial rate of false-positive sudden death classification.
BACKGROUND: Serial antiarrhythmic drug testing guided by Holter monitoring and electrophysiologic study had similar clinical outcomes in the Electrophysiologic Study versus Electrocardiographic Monitoring (ESVEM) trial, while patients treated with sotalol had improved outcomes. The purpose of this study was to compare long-term cost-effectiveness of these management alternatives. METHODS: Patients in the ESVEM trial were linked to computerized files of either the Health Care Finance Administration or the Department of Veterans Affairs. Total hospital costs and survival time over five year follow-up were measured using actuarial methods, and cost-effectiveness was calculated. RESULTS: Patients randomized to therapy guided by electrophysiologic study had more hospital admissions, higher costs, and a cost-effectiveness ratio of $162,500 per life year added compared with therapy guided by Holter monitoring. Patients randomized to sotalol had fewer hospitalizations, lower costs, and better survival than patients randomized to other drugs, and sotalol was a dominant strategy in the cost-effectiveness analysis. Patients for whom an effective drug was found had fewer hospital admissions, lower costs, and longer survival. These findings were robust in sensitivity analyses and in bootstrap replications. CONCLUSIONS: Serial drug testing guided by electrophysiologic study had an unfavorable cost-effectiveness ratio relative to Holter monitoring, while sotalol was cost-effective relative to other antiarrhythmic drugs.
BACKGROUND: Wide geographic variation in the use of coronary angiography after myocardial infarction has been documented internationally and within the United States. An associated variation in clinical outcomes has not been consistently demonstrated. METHODS: We assessed the risk of death from heart disease and of any heart disease event (death, reinfarction, or rehospitalization) over a follow-up period of one to four years in 6851 patients hospitalized with acute myocardial infarction at 16 Kaiser Permanente hospitals from 1990 through 1992. The percentage of patients who underwent angiography within three months after infarction ranged from 30 to 77 percent. We selected a subcohort of 1109 patients from three hospitals with higher rates of angiography and four with lower rates for a record review to assess the severity of infarction, the number of coexisting conditions, treatments received, and the appropriateness and necessity of angiography, using established criteria. RESULTS: The rates of angiography were inversely related to the risk of death from heart disease (P= 0.03) and the risk of heart disease events (P<0.001) among the 16 hospitals after adjustment for age, sex, race, coexisting conditions, and the location of the infarction (subendocardial vs. transmural). In the subcohort, 440 patients met criteria indicating that angiography was necessary and 669 did not. Among the former, patients treated at hospitals with higher rates of angiography had a lower risk of death and of any heart disease event than those treated at hospitals with lower rates (hazard ratios, 0.67 and 0.72, respectively). Among the latter, the apparent benefits of being treated at hospitals with higher angiography rates were smaller (hazard ratios, 0.85 to 0.90 for death and any heart disease event, respectively). CONCLUSIONS: During the one to four years after myocardial infarction, patients treated at hospitals with higher rates of angiography had more favorable outcomes than those treated at hospitals with lower rates. This association was stronger among patients for whom published criteria indicated that angiography was necessary.