Prognostic value of ventricular arrhythmias associated with treadmill exercise testing in patients studied with cardiac catheterization for suspected ischemic heart disease.

The prognostic information provided by ventricular arrhythmias associated with treadmill exercise testing was evaluated in 1,293 consecutive nonsurgically treated patients undergoing an exercise test within 6 weeks of cardiac catheterization. The 236 patients with simple ventricular arrhythmias (at least one premature ventricular complex, but without paired complexes or ventricular tachycardia) had a higher prevalence of significant coronary artery disease (57 versus 44%), three vessel disease (31 versus 17%) and abnormal left ventricular function (43 versus 24%) than did patients without ventricular arrhythmias. Patients with paired complexes or ventricular tachycardia had an even higher prevalence of significant coronary artery disease (75%), three vessel disease (39%) and abnormal left ventricular function (54%). In the 620 patients with significant coronary artery disease, patients with paired complexes or ventricular tachycardia had a lower 3 year survival rate (75%) than did patients with simple ventricular arrhythmias (83%) and patients with no ventricular arrhythmias (90%). Ventricular arrhythmias were found to add independent prognostic information to the noninvasive evaluation, including history, physical examination, chest roentgenogram, electrocardiogram and other exercise test variables (p = 0.03). Ventricular arrhythmias made no independent contribution once the cardiac catheterization data were known. In patients without significant coronary artery disease, no relation between ventricular arrhythmias and survival was found.

Clinical judgment and statistics. Lessons from a simulated randomized trial in coronary artery disease.

A simulated randomized clinical trial in coronary artery disease was conducted to illustrate the need for clinical judgment and modern statistical methods in assessing therapeutic claims in studies of complex diseases. Clinicians should be aware of problems that occur when a patient sample is subdivided and treatment effects are assessed within multiple prognostic categories. In this example, 1073 consecutive, medically treated coronary artery disease patients from the Duke University data bank were randomized into two groups. The groups were reasonably comparable and, as expected, there was no overall difference in survival. In a subgroup of 397 patients characterized by three-vessel disease and an abnormal left ventricular contraction, however, survival of group 1 patients was significantly different from that of group 2 patients. Multivariable adjustment procedures revealed that the difference resulted from the combined effect of small imbalances in the distribution of several prognostic factors. Another subgroup was identified in which a significant survival difference was not explained by multivariable methods. These are not unlikely examples in trials of a complex disease. Clinicians must exercise careful judgment in attributing such results to an efficacious therapy, as they may be due to chance or to inadequate baseline comparability of the groups.

The prognostic spectrum of left main stenosis.

Three-year survival for 163 consecutive medically treated patients with 50% or greater left main stenosis was 50%. Survival was significantly higher for patients with 50 to 70% left main stenosis (one and three-year survivals of 91% and 66%) than for patients with 70% or greater left main stenosis (one and three-year survivals of 72% and 41%). In fact, left main lesions of less than 70% were not associated with the increased risk usually attributed to patients with left main stenosis. A number of noninvasive and catheterization characteristics were significant predictors of survival for patients with 70% or greater left main stenosis. Noninvasive descriptors defined a low risk subgroup (one and three-year survivals of 97% and 74%) and a high risk subgroup (one- and three-year survivals of 59% and 25%). These observations have important implications both in assessing therapeutic interventions and in managing individual patients.

Hospital discharge one week after acute myocardial infarction.

Sixty-seven consecutive patients who had suffered an acute myocardial infarction but no serious complications during the first to fourth hospital days were considered for a trial of hospital discharge at one week. Thirty-three of the 67 patients were discharged at one week, the remainder having a mean hospital stay of 11 +/- 2 days. The incidence of late complications and recurrent infarctions, as well as mortality and functional status, were determined in all patients six months after discharge. No serious complications occurred in either subgroup within three weeks after discharge. There were no deaths in either subgroup and no difference in functional status at six months. Patients without serious complications during the four days after an acute myocardial infarction can be spared the economic costs and psychologic stress of prolonged hospitalization.

The role of the exercise test in the evaluation of patients for ischemic heart disease.

A cohort of 1472 patients who underwent both exercise stress testing and coronary angiography within six weeks was examined. The data indicated that a combination of exercise parameters is both diagnostically and prognostically important. Almost all patients (greater than 97%) who had positive exercise tests at Stage I or Stage II had significant coronary artery disease. More than half of these (greater than 60%) had three vessel disease and over 25% had significant narrowing (greater than 50%) of the left main coronary artery. Patients who achieved Stage IV or greater exercise durations with either negative or indeterminate ST-segment response had less than a 15% prevalence of three vessel disease and less than a 1% prevalence of left main coronary artery disease. A low risk subgroup (75% of all non-operated patients) was identified with a twelve month survival greater than 99%. A high risk subgroup (11% of all nonoperated patients) was identified with a twelve month survival of less than 85%. The exercise test is a noninvasive, reproducible method to assess the presence and extent of anatomic disease and the prognosis when significant disease has been defined. It should be used in conjunction with other noninvasive tests to determine optimal management in patients evaluated for ischemic heart disease.

The natural history of coronary artery disease: an update on surgical and medical management.

The current series represents the total experience of one institution that has treated concurrently a large number of patients with medical or surgical therapy. As previously reported, surgery offers a greater chance for pain relief but no obvious protection from future myocardial infarction. Patients with single artery disease show no difference in survival or future myocardial infarction rate whether treated medically or surgically. Improvement in survival following surgery, determined by univariate analysis of clinical descriptors, in several subsets of patients in the present series has not been confirmed when multivariate analysis techniques are used. If surgical mortality can be further lowered there may well be subsets of patients with coronary artery disease who will outsurvive similar medically treated patients. The current and future natural history of coronary artery disease, whether treated medically or surgically, is not settled by this or any other series because both forms of therapy are rapidly changing and no current series meets valid statistical criticisms. We are in a state of evaluation concerning not only therapeutic approaches, but also the development of suitable statistical methods for determining the efficacy of various forms of therapy. Only by continual modification of therapeutic approaches and the statistical tools to measure their effectiveness can we approach confident conclusions.

Cardiac arrest complicating acute myocardial infarction: predictability and prognosis.

Eleven percent of 905 consecutive patients with acute myocardial infarction admitted to the coronary care unit at Duke University Medical Center experienced cardiac arrest. Subgroups of patients at high and low risk for cardiac arrest were identified. Cardiac arrest was experienced by 17 percent of patients with signs of heart failure on admission but by only 3 percent of patients without diabetes mellitus, prior myocardial infarction or heart failure by history or on admission. Only 59 percent of patients with cardiac arrest survived hospitalization compared with 88 percent of those without cardiac arrest. Long-term survival for the 765 hospital survivors was significantly greater in the group without than in the group with arrest at each yearly interval from 1 through 5 years; the 2 year survival rate was 50 and 77 percent, respectively, in these two groups. Many of the deaths among the hospital survivors occurred in patients with signs of heart failure during hospitalization. Among 668 hospital survivors who had mild or no heart failure during hospitalization, cardiac arrest continued to be a significant predictor of mortality. The mode of death among hospital survivors did not differ in the groups with and without cardiac arrest; for example, the incidence rate of sudden death in the two groups was 44 and 37 per cent, respectively. In light of recent reports suggesting that the prophylactic use of antiarrhythmic agents can virtually eliminate virtually fibrillation during the hospital phase of acute myocardial infarction, we contend that such use may substantially reduce both long-term and hospital mortality after acute myocardial infarction.

Does coronary surgery prolong life in comparison with medical management?

This analysis attempts to utilize natural history controls to answer the question as to whether coronary surgery prolongs life in comparison to medical management. Selected natural history studies are compared and contrasted in an effort to obtain an average survival curve for patients with coronary artery disease comparable to those presently being operated. The Duke University Medical Center series of concurrent operated and non-operated patients is reviewed to demonstrate the difference of prognosis of patients with coronary artery disease and the complexities involved in answering the question. It is concluded that, on average, coronary surgery does not prolong life in comparison to medical management over the span of 2-5 years. There may be certain higher risk patients whose lives may be prolonged by aortocoronary bypass surgery but more patients and more prolonged follow-up are needed fully to answer the question.

Sudden death due to coronary artery disease. A clinical, hemodynamic, and angiographic profile.

The authors followed 536 medically managed patients with angiographically documented coronary artery disease for up to 4 years, and examined antemortem clinical, anatomical, and hemodynamic characteristics of the 29 patients who died suddenly during the follow-up period. These patients are compared in terms of hemodynamic characteristics to those who survived and those who died non-suddenly of coronary heart disease. Of the 29 patients who died suddenly, more than 80% had evidence of moderate to severe impairment of myocardial function many months prior to death. Only a single patient had the combination of relatively mild coronary artery disease and normal ventricular function. This single patient would be the ultimate target of a program designed to prevent sudden death. However, it has been necessary to follow 536 patients with angiographically documented coronary artery disease in order to find this one potential benefactor of sudden death prophylaxis. This study demonstrates that there are patients with coronary artery disease who die suddenly, despite relatively mild disease; however, these patients appear to represent only a small proportion of all sudden deaths.

A new information system for medical practice.

A data bank containing our clinical experience with more than 3,000 patients with suspected and documented ischemic heart disease is being used to expand our ability to care for patients. This report describes how the experience is documented, stored, and retrieved so that it can be used in patient management. Data acquisition is integrated with patient care by means of forms that are part of the patient record. Follow-up information is obtained at six months, one year, and yearly thereafter. All data are stored in a computer information system that allows the doctor to recall the experience of patients like his new patient. Prognostic information is available on each new patient both on-line and in the form of a printed laboratory report. The data bank represents an initial chapter of a computer textbook of medicine.

The course of acute myocardial infarction. Feasibility of early discharge of the uncomplicated patient.

This report represents our experience with 522 consecutive patients with acute myocardial infarction admitted directly to the Duke Coronary Care Unit. Fifty items of information were used to characterize the patients, their hospital course and follow-up. Serious complications included death, ventricular tachycardia or fibrillation, second- or third-degree heart block, pulmonary edema, cardiogenic shock, persistent sinus tachycardia or hypotension, atrial flutter or fibrillation, and extension of infarction. Forty-nine percent of the patients (252 of 522) experienced a serious complication. All patients who experienced any serious complications had at least one of the above during the first four days of hospitalization. Patients who survived through day 4 were subgrouped on the basis of the occurrence (complicated) or lack of occurrence (uncomplicated) of the above on day 5. Complicated patients had a subsequent hospital mortality of 14% and an incidence of late serious complications of 51%. Patients who were uncomplicated through day 4 had a subsequent hospital mortality of zero and an incidence of late serious complications of zero. These data suggest that it would be feasible and ethically justified to conduct a prospective clinical trial of early discharge (7th day) in patients who meet the above criteria for uncomplicated. The potential economic savings through earlier discharge in uncomplicated patients are of major significance.