Introductory remarks by the Honorable Justice Stewart G. Pollock at Seton Hall University School of Law.

This address is based upon a presentation given at Seton Hall University School of Law's Seventh Annual Health Law Symposium on February 12, 1999.

Value of two-dimensional echocardiography for determining the basis of hemodynamic compromise in critically ill patients: a prospective study.

We postulated that because the first step in the management of critically ill patients with hypotension, pulmonary edema, or both is to determine whether the cause is cardiac or noncardiac, direct visualization of the heart with two-dimensional echocardiography would be useful for determining the basis of hemodynamic compromise in such patients. Accordingly, 49 consecutive patients (33 men and 16 women; mean age 61 +/- 15 years) underwent two-dimensional echocardiography within 2 hours of placement of a pulmonary artery flotation catheter for determining the reason for hypotension, pulmonary edema, or both. To discriminate between cardiac and noncardiac causes, hemodynamic and two-dimensional echocardiographic data were evaluated independently by two to three blinded interpreters based on predetermined criteria. There was complete agreement between pulmonary artery catheter and two-dimensional echocardiographic data in 36 (86%) of the 42 patients in whom interpretable data were available in terms of cardiac versus noncardiac causes. The two modalities agreed in all patients with hypotension alone and disagreed in 2 of the 20 patients with pulmonary edema alone and 4 of the 14 patients with combined hypotension and pulmonary edema. In cases of discordance, the two tests provided complimentary information, particularly in patients with sepsis in whom the stroke volume may be normal to high but left ventricular systolic function may be depressed. The time taken for pulmonary artery catheter placement was 63 +/- 45 minutes versus 19 +/- 7 minutes for two-dimensional echocardiography.(ABSTRACT TRUNCATED AT 250 WORDS)

Starr-Edwards valve thrombosis detected preoperatively by transesophageal echocardiography.

A 31-year-old woman developed increasing signs of congestive heart failure 15 years following placement of a mitral Starr-Edwards mechanical valve. A preoperative transesophageal echocardiogram (TEE) demonstrated a large, obstructive valvular thrombus and the patient underwent successful reoperative valve replacement.

Value and limitations of current methods of evaluating patients presenting to the emergency room with cardiac-related symptoms for determining long-term prognosis.

The goal of this study was to determine the value and limitations of the current approach for evaluating patients in the emergency room (ER) with cardiac-related symptoms in terms of predicting long-term outcome. Accordingly, 274 consecutive prospectively identified patients presenting to the ER with such symptoms were evaluated, and follow-up was obtained at 20 +/- 9 months in 265 of them (97%). Adverse cardiovascular events were defined as: nonfatal myocardial infarction, death, cerebrovascular accident with neurologic deficit, life-threatening arrhythmia and cardiac surgery. Eighty-three patients (31%) had a cardiovascular event during follow-up; 42 occurred within 48 hours of ER presentation, whereas 41 occurred in the ensuing months. Findings on physical examination and electrocardiogram provided additional prognostic information, compared with that of history alone, when added sequentially into a Cox model. However, by discriminant function analysis, only 63% of actual events were correctly predicted by the model. Events occurring after 48 hours of ER presentation were correctly predicted only 50% of the time compared with those occurring within 48 hours of ER presentation, which were correctly predicted 75% of the time (p = 0.04). It is concluded that patients presenting to the ER with cardiac-related symptoms are at high risk for adverse cardiovascular events. The likelihood of an event occurring after 48 hours of presentation is as high as one occurring within 48 hours. Current methods of evaluating such patients have limited prognostic value, particularly for those at long-term risk for events.

Independent and incremental prognostic value of tests performed in hierarchical order to evaluate patients with suspected coronary artery disease. Validation of models based on these tests.

BACKGROUND: The additive prognostic value of tests done in a hierarchical order for the detection of coronary artery disease (CAD) is not always known. The principal goal of this study, therefore, was to assess the incremental prognostic value of data obtained in succession (clinical, exercise stress testing, 201Tl imaging, and coronary angiography) in patients with suspected CAD. A second goal was to develop models for determining prognosis based on results of these tests and to test the clinical validity of these models in unrelated patients. METHODS AND RESULTS: Data from two groups of patients who had undergone such evaluation and had been followed for a mean of 4.4 years were analyzed. There were 204 patients from Massachusetts General Hospital (MGH) and 299 from the University of Virginia (UVA). There were 20 deaths and 21 nonfatal infarctions in the MGH group and 41 deaths and nine infarctions in the UVA group. Both univariate and multivariate Cox regression analyses were performed to assess the individual and incremental prognostic value of these tests. In both groups, 201Tl imaging provided significant additional prognostic information compared with clinical and exercise stress test data (p less than 0.05). At MGH, where the lung/heart 201Tl ratio had been analyzed, coronary angiography did not provide additional prognostic information. In this group of patients, the combination of clinical and exercise 201Tl variables provided greater prognostic information than the combination of clinical and angiographic data (p less than 0.001). In the UVA cohort, in which the lung/heart ratio had not been analyzed, coronary angiography provided incremental prognostic information compared with clinical and exercise 201Tl data alone (p less than 0.05). When models developed using data from either sample were applied to the other unrelated sample, there was often close agreement between the overall observed rates and those predicted by the models. This was also true for the low-risk and high-risk subgroups. Some models, however, did not perform as well as other models, which suggests that models that do well in one sample may not always be generalized to other groups. CONCLUSIONS: Tests performed in hierarchical order for the evaluation of suspected CAD provide additional prognostic information. Models developed using clinically relevant combinations of test results obtained from different patient populations are frequently able to predict absolute levels of survival in unrelated but similar samples.

A model to predict multivessel coronary artery disease from the exercise thallium-201 stress test.

PURPOSE: The aim of this study was to (1) determine whether nonimaging variables add to the diagnostic information available from exercise thallium-201 images for the detection of multivessel coronary artery disease; and (2) to develop a model based on the exercise thallium-201 stress test to predict the presence of multivessel disease. PATIENTS AND METHODS: The study populations included 383 patients referred to the University of Virginia and 325 patients referred to the Massachusetts General Hospital for evaluation of chest pain. All patients underwent both cardiac catheterization and exercise thallium-201 stress testing between 1978 and 1981. RESULTS: In the University of Virginia cohort, at each level of thallium-201 abnormality (no defects, one defect, more than one defect), ST depression and patient age added significantly in the detection of multivessel disease. Logistic regression analysis using data from these patients identified three independent predictors of multivessel disease: initial thallium-201 defects, ST depression, and age. A model was developed to predict multivessel disease based on these variables. As might be expected, the risk of multivessel disease predicted by the model was similar to that actually observed in the University of Virginia population. More importantly, however, the model was accurate in predicting the occurrence of multivessel disease in the unrelated population studied at the Massachusetts General Hospital. CONCLUSION: It is, therefore, concluded that (1) nonimaging variables (age and exercise-induced ST depression) add independent information to thallium-201 imaging data in the detection of multivessel disease; and (2) a model has been developed based on the exercise thallium-201 stress test that can accurately predict the probability of multivessel disease in other populations.

Usefulness of bucindolol in congestive heart failure.

The sympathetic hyperactivity of congestive heart failure (CHF) may worsen cardiovascular function by down-regulation of myocardial beta-receptors. For this reason, beta blockade is proposed to be useful in CHF. Bucindolol is a new beta blocker that has intrinsic nonadrenergically-mediated vasodilation and may be valuable in treatment of CHF. To test this, 19 patients with CHF were randomized in a double-blind protocol to 3 months of treatment with bucindolol (n = 12) or placebo (n = 7). Significant improvement was seen in the bucindolol group using invasive and noninvasive tests; treadmill time increased from 445 to 530 seconds (p = 0.04), Minnesota Living With Heart Failure Questionnaire score improved from 61 to 40 (p = 0.0001), cardiac output increased from 4.0 to 4.7 (p = 0.02), and systemic vascular resistance decreased from 1,888 to 1,481 (p = 0.04). Also, peak exercise heart rate and pulmonary capillary wedge pressure decreased significantly with treatment. There were no changes in the placebo group. We conclude that bucindolol may be an effective treatment for CHF when administered chronically and that its nonadrenergic vasodilation may be an important feature.

A simplified approach for evaluating multiple test outcomes and multiple disease states in relation to the exercise thallium-201 stress test in suspected coronary artery disease.

This study describes a simplified approach for the interpretation of electrocardiographic and thallium-201 imaging data derived from the same patient during exercise. The 383 patients in this study had also undergone selective coronary arteriography within 3 months of the exercise test. This matrix approach allows for multiple test outcomes (both tests positive, both negative, 1 test positive and 1 negative) and multiple disease states (no coronary artery disease vs 1-vessel vs multivessel coronary artery disease). Because this approach analyzes the results of 2 test outcomes simultaneously rather than serially, it also negates the lack of test independence, if such an effect is present. It is also demonstrated that ST-segment depression on the electrocardiogram and defects on initial thallium-201 images provide conditionally independent information regarding the presence of coronary artery disease in patients without prior myocardial infarction. In contrast, ST-segment depression on the electrocardiogram and redistribution on the delayed thallium-201 images may not provide totally independent information regarding the presence of exercise-induced ischemia in patients with or without myocardial infarction.

Effect of the degree of effort on the sensitivity of the exercise thallium-201 stress test in symptomatic coronary artery disease.

The sensitivity of ST-segment depression on the electrocardiogram during exercise is influenced by the level of effort. Whether such is the case with thallium-201 imaging (initial defect or redistribution) has not been established. Accordingly, the prevalence of these parameters was evaluated in 288 patients (age 59 +/- 10 years, 88% men) with coronary artery disease who underwent both exercise thallium-201 imaging and coronary angiography within 3 months of each other: 159 had a prior myocardial infarction, 72 had 1-vessel, and 216 had multivessel disease. The degree of effort was evaluated by 3 criteria: (1) percentage of maximal predicted heart rate (less than or equal to 65, greater than 65 to 85, greater than 85%); (2) workload during exercise (less than or equal to 4, greater than 4 to 8, greater than 8 METs); and (3) duration of exercise (less than or equal to 3, greater than 3 to 6, greater than 6 minutes). The prevalence of defects on initial images was higher than both redistribution on delayed images and ST-segment depression on the electrocardiogram (p less than 0.01). The overall prevalence of initial defects remained the same for all levels of effort and was not influenced by the presence or absence of a prior infarction. However, it decreased in patients with 1-vessel disease who exercised to higher workloads. The prevalence of redistribution on delayed thallium-201 images was higher than that of ST-segment depression on the electrocardiogram (p less than 0.01), except at higher levels of effort where they were similar.(ABSTRACT TRUNCATED AT 250 WORDS)