Clinical determinants of mortality in patients with angiographically diagnosed ischemic or nonischemic cardiomyopathy.

OBJECTIVES: We sought to characterize the clinical determinants of mortality in patients with angiographically diagnosed ischemic or nonischemic cardiomyopathy. BACKGROUND: Patients with ischemic cardiomyopathy may have a worse prognosis than patients with nonischemic cardiomyopathy. Few studies have assessed the effect of ischemic versus nonischemic etiology on outcomes. METHODS: We analyzed prospectively collected data on 3,787 patients with a left ventricular ejection fraction < or = 40% who underwent coronary angiography. Patients were considered to have ischemic cardiomyopathy (n = 3,112) if they had a history of myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft surgery or at least one major epicardial coronary artery with > or = 75% stenosis; all others were considered to have nonischemic cardiomyopathy (n = 675). RESULTS: The median age, ejection fraction and proportion of patients with New York Heart Association functional class III or IV symptoms for the nonischemic and ischemic groups were 55 years versus 63 years, 27% versus 32% and 57% versus 25%, respectively. After adjustment for baseline clinical risk factors and presenting characteristics, ischemic etiology remained an important independent predictor of 5-year mortality (p < 0.0001). The extent of coronary artery disease was a better predictor of survival than ischemic or nonischemic etiology (log likelihood chi-square 700 vs. 675, respectively). CONCLUSIONS: Ischemic etiology is a significant independent predictor of mortality in patients with cardiomyopathy. However, the extent of coronary artery disease contributes more prognostic information than the clinical diagnosis of ischemic or nonischemic cardiomyopathy. Further research is needed to refine the clinical definition of ischemic cardiomyopathy so that physicians can appropriately prescribe treatment and accurately predict outcome.

Outcome of acute myocardial infarction according to the specialty of the admitting physician.

BACKGROUND: In order to limit costs, health care organizations in the United States are shifting medical care from specialists to primary care physicians. Although primary care physicians provide less resource-intensive care, there is little information concerning the effects of this strategy on outcomes. METHODS: We examined mortality according to the specialty of the admitting physician among 8241 Medicare patients who were hospitalized for acute myocardial infarction in four states during a seven-month period in 1992. Proportional-hazards regression models were used to examine survival up to one year after the myocardial infarction. To determine the generalizability of our findings, we also examined insurance claims and survival data for all 220,535 patients for whom there were Medicare claims for hospital care for acute myocardial infarction in 1992. RESULTS: After adjustment for characteristics of the patients and hospitals, patients who were admitted to the hospital by a cardiologist were 12 percent less likely to die within one year than those admitted by a primary care physician (P<0.001). Cardiologists also had the highest rate of use of cardiac procedures and medications, including medications (such as thrombolytic agents and beta-blockers) that are associated with improved survival. CONCLUSIONS: Health care strategies that shift the care of elderly patients with myocardial infarction from cardiologists to primary care physicians lower rates of use of resources (and potentially lower costs), but they may also cause decreased survival. Additional information is needed to elucidate how primary care physicians and specialists should interact in the care of severely ill patients.

Compression of digital coronary angiograms does not affect visual or quantitative assessment of coronary artery stenosis severity.

Digital coronary angiographic techniques are now widely used in many cardiac catheterization laboratories. However, the full potential of digital imaging technology remains to be achieved because of its enormous storage and exchange requirements. Compression of digital imaging data allows a reduction in the volume of data so that storage and transmission are more efficient and cost-effective. Three angiographers reviewed the original and compressed formats of 96 coronary angiographic sequences in a blinded fashion to assess coronary lesion severity. Compression was achieved using the Joint Photographic Experts Group (JPEG) standard, which resulted in a compression ratio of approximately 15:1. The original format was reviewed in a blinded fashion a second time to assess for intraobserver variability of similar formats. Lesion severity was graded in quartiles. Coronary stenosis >50% was considered "significant." In parallel, the reproducibility of quantitative coronary angiographic (QCA) measurements of coronary artery dimensions was also evaluated. For the visual assessment of lesion severity in the compressed versus original formats, kappa=0.52, suggesting moderate agreement. When lesions were assessed as significant versus "insignificant," however, kappa=0.88, suggesting excellent agreement. In the 2 separate readings of the original data formats, kappa=0.44 for assessment of lesion severity by quartiles and kappa=0.72 for lesions assessed as significant versus insignificant. Analysis of the compressed versus original data sets using QCA resulted in an excellent correlation for the measurement of lesion severity (r=0.99). The correlation was equally strong when the original format was analyzed sequentially (r=0.98). Lossy JPEG (15:1) compression is a valid means for reducing storage and exchange requirements of coronary angiographic data. The variability in assessing lesion severity between the original and compressed formats is comparable to the reported variability in visual assessment of lesion severity in sequential analysis of cine film.

Managing the delivery of health care: care-plans/managed care/practice guidelines.

Concerns about increasing costs of health care combined with an increasing appreciation of the variability in health care delivery practices has led to the development of strategies to better standardise health care delivery. Care-plans and practice algorithms define road maps of care and decision algorithms for individual patient conditions. When incorporated into routine clinical practice and coupled with the recording of the outcomes of care, they permit an improved understanding of how to provide more cost-effective health care. Routine integration into information systems should help to establish a continuous quality improvement model for health care delivery. Substantial problems exist, however, in the development of care-plans and integrating them into information systems and routine clinical practice.

Predicting the risk of abrupt vessel closure after angioplasty in an individual patient.

OBJECTIVES: We proposed to examine the relation between angiographic morphologic characteristics and abrupt closure after coronary angioplasty and to develop an empirically based risk stratification system. BACKGROUND: Certain lesion morphologic characteristics are associated with higher rates of abrupt closure after coronary angioplasty. Previous approaches have been limited by relatively small sample sizes and an inability to combine multiple characteristics to predict risk in an individual patient. METHODS: Lesion morphology was determined for 779 lesions in 658 patients undergoing an elective first angioplasty. Abrupt closure occurred in 63 lesions (8.1%). Variables associated with abrupt closure were identified by univariate and stepwise multiple logistic regression analysis, and internal validity was assessed by use of bootstrapping. An empirically based scoring system was developed by assigning different weights to each predictive characteristic and was then validated. RESULTS: Almost all lesion characteristics previously labeled "adverse" were associated with an increased risk of abrupt closure, but only total occlusion, location at a branch point, increasing lesion length, evidence for thrombus and right coronary artery location were statistically significant independent predictors. Despite the large sample size, the study was underpowered to detect even a 50% increase in risk with many characteristics. Using a scoring system, we assigned each lesion a specific risk of abrupt closure. The distribution of risk was broad, with 20% of patients having < or = 2.5% risk and 25% having > 10% risk. Internal validation techniques revealed that when 10% of patients were randomly eliminated from the sample in multiple iterations, the risk estimates varied, again pointing to the need for a larger sample. CONCLUSIONS: Empirically based weighting of lesion characteristics could quantify the risk of abrupt closure for individual patients, but a very large sample will be required to understand the interplay of complex lesion characteristics in altering expected outcomes.

Which media are most likely to solve the archival problem?

The clinical application of quantitative methods for coronary arteriography remains limited, due in large part to the absence of a suitable replacement for cinefilm as the procedure record. The extension to the clinical environment of the validated objective methods which have found such widespread acceptance in clinical research studies is difficult to implement if the time-consuming and variable process for digitization of selected cinefilm frames is required. In addition, the complete integration of the angiographic procedure record with other patient records and procedures stored in a digital data format requires that the angiographic data eventually be converted to a digital format as well. Replacement of cinefilm requires that the media chosen for the task provide at least the same capabilities and preferably improved functions as those provided by cinefilm as a display, transport, and archival media. The demanding set of requirements imposed on the replacement options include high capacity, high acquisition rate, high transfer rate, application in a distributed environment, portability between institutions, and low expense. A true digital solution should also provide immediate access to the results of the angiographic procedure, transfer of image data over digital networks, multiple-user viewing capability, and quantitative analysis on a routine basis for all patients. In fact, a single media may not provide all the capabilities listed above but, rather, different media may need to be used for specialized tasks, i.e. the solution for archival may not be the same that will be employed as the portable patient record. Separation of the archival function from the acquisition/display and portable transfer functions increases the likelihood that cinefilm can be replaced in the imminent future by reducing the demands on a single media. Among the archival options available today are: (1) magnetic disks; (2) analog laser optical disks; (3) digital laser optical disks; (4) digital file-based magnetic tape; (5) digital video magnetic tape. In evaluating each of these alternatives, an accounting is required of how each meets the archival requirements along with an approximate breakdown of cost and readiness for implementation as a clinical solution today.

Continuing evolution of therapy for coronary artery disease. Initial results from the era of coronary angioplasty.

BACKGROUND: Survival after coronary artery bypass graft surgery (CABG) and medical therapy in patients with coronary artery disease (CAD) has been studied in both randomized trials and observational treatment comparisons. Over the past decade, the use of coronary angioplasty (PTCA) has increased dramatically, without guidance from either randomized trials or prospective observational comparisons. The purpose of this study was to describe the survival experience of a large prospective cohort of CAD patients treated with medicine, PTCA, or CABG. METHODS AND RESULTS: The study was designed as a prospective nonrandomized treatment comparison in the setting of an academic medical center (tertiary care). Subjects were 9263 patients with symptomatic CAD referred for cardiac catheterization (1984 through 1990). Patients with prior PTCA or CABG, valvular or congenital disease, nonischemic cardiomyopathy, or significant (> or = 75%) left main disease were excluded. Baseline clinical, laboratory, and catheterization data were collected prospectively in the Duke Cardiovascular Disease Databank. All patients were contacted at 6 months, 1 year, and annually thereafter (follow-up 97% complete). Cardiovascular death was the primary end point. Of this cohort, 2788 patients were treated with PTCA (2626 within 60 days) and 3422 with CABG (3080 within 60 days). Repeat or crossover revascularization procedures were counted as part of the initial treatment strategy. Kaplan-Meier survival curves (both unadjusted and adjusted for all known imbalances in baseline prognostic factors) were used to examine absolute survival differences, and treatment pair hazard ratios from the Cox model were used to summarize average relative survival benefits. For the latter, a 13-level CAD prognostic index was used to examine the relation between survival and revascularization as a function of CAD severity. The effects of revascularization on survival depended on the extent of CAD. For the least severe forms of CAD (ie, one-vessel disease), there were no survival advantages out to 5 years for revascularization over medical therapy. For intermediate levels of CAD (ie, two-vessel disease), revascularization was associated with higher survival rates than medical therapy. For less severe forms of two-vessel disease, PTCA had a small advantage over CABG, whereas for the most severe form of two-vessel disease (with a critical lesion of the proximal left anterior descending artery), CABG was superior. For the most severe forms of CAD (ie, three-vessel disease), CABG provided a consistent survival advantage over medicine. PTCA appeared prognostically equivalent to medicine in these patients, but the number of PTCA patients in this subgroup was low. CONCLUSIONS: In this first large-scale, prospective observational treatment comparison of PTCA, CABG, and medicine, we confirmed the previously reported survival advantages for CABG over medical therapy for three-vessel disease and severe two-vessel disease. For less severe CAD, the primary treatment choices are between medicine and PTCA. In these patients, there is a trend for a relative survival advantage with PTCA, although absolute survival differences were modest. In this setting, treatment decisions should be based not only on survival differences but also on symptom relief, quality of life outcomes, and patient preferences.

Long-term outcome following successful reopening of abrupt closure after coronary angioplasty.

Abrupt closure after coronary angioplasty is often successfully treated by repeat dilation. Long-term follow-up, including 6-month repeat catheterization and 12-month clinical evaluation, was obtained in 1,056 patients treated with acute (n = 335) or elective (n = 721) coronary angioplasty to evaluate the long-term impact of successful reopening of abrupt closure. Abrupt closure occurred in 13.5% of patients and was successfully reopened in 58%. Adverse outcomes including restenosis, death, bypass surgery, myocardial infarction and repeat angioplasty were compared between patients with successfully treated abrupt closure and those with successful procedures (residual diameter stenosis < or = 50%) without abrupt closure. For patients with acute angioplasty, the restenosis rates (> 50% diameter stenosis at follow-up) were 64% for those with successfully treated abrupt closure versus 36% for those with successful procedures without abrupt closure (p < 0.01). In addition, subsequent myocardial infarction (12 vs 3%; p = 0.01) and repeat angioplasty (21 vs 10%; p = 0.03) were more frequent in the group with abrupt closure. For patients with elective angioplasty, restenosis was 43% in those with successfully treated abrupt closure versus 45% in those without abrupt closure (p = NS). Subsequent death and myocardial infarction were more frequent in patients with abrupt closure (death: 12 vs 3% [p < 0.01]; myocardial infarction: 13 vs 3% [p < 0.01]). Long-term adverse events are increased in patients with successfully treated abrupt closure compared to those with successful procedures without abrupt closure.

Treatment of long coronary artery narrowings with long angioplasty balloon catheters.

Balloon angioplasty of long coronary artery narrowings has been associated with a lower rate of acute success, and a higher rate of acute complications and restenosis than that observed for short narrowings. Angioplasty catheters with longer length balloons (30 and 40 mm) are now available, and the objective of this study was to determine the acute and long-term success for patients with long coronary artery narrowings treated with these longer balloons. All patients with long narrowings (> or = 10 mm) treated with long balloons at 1 institution over a 1-year period were identified (93 narrowings in 89 patients), and acute and long-term outcomes were carefully documented. Procedural success (residual stenosis < or = 50%) was 97%. Abrupt closure occurred in 6% and major dissection in 11% of narrowings. Clinical success (procedural success without in-hospital death, bypass surgery or myocardial infarction) was achieved in 90% of patients. Repeat catheterization was performed in 61 patients (76% of those eligible), and restenosis was found in 50 to 55%, depending on the definition used. The treatment of long coronary artery narrowings using angioplasty catheters with longer balloons leads to high rates of acute success. However, there is a high rate of restenosis. New interventional devices for long lesions should be compared with long balloons in a randomized controlled trial.

Quantitative and qualitative coronary angiographic analysis: review of methods, utility, and limitations.

Coronary angiography continues to be the pivotal study in the diagnosis and treatment of ischemic cardiac disease. Although angiographic equipment and imaging techniques have advanced over the past three decades, the analysis of coronary angiograms, by visual estimated percent diameter stenosis, has remained unchanged in most clinical catheterization laboratories. Rapid, computerized angiographic analysis systems are now available that remedy the inherent imprecision and inaccuracies plaguing visual coronary analysis. Despite its advantages, successful QCA is quite dependent on meticulous attention to radiographic and angiographic technique, even more so than with visual analysis. Although the available QCA systems can reproducibly and accurately define the site and degree of coronary stenosis, they cannot routinely determine whether an obstruction is flow limiting. Several methods, some based on extrapolations of quantitative measures alone, and others based on digital subtraction angiography, have been developed to determine the physiologic impact of a given coronary lesion. Recent observations have demonstrated, however, that even if the physiologic consequences of an obstruction are known, the prognosis of the lesion over time cannot be predicted. The qualitative, morphologic characteristics of a lesion are as, or more, important than the quantitative lesion attributes in determining an atheroma's behavior and stability, and hence, qualitative descriptors should be incorporated into QCA analyses. Although not currently available, future QCA systems will provide, by automated analysis, reproducible and accurate measures of absolute obstruction, physiologic data describing the flow limiting characteristics of a lesion, and qualitative, morphologic lesion descriptors. Implementation of these systems should provide more consistent and accurate prognostic and pathophysiologic information, thereby helping to refine and more effectively direct therapeutic interventions in coronary artery disease.

Clinical risks of thrombolytic therapy.

Understanding the clinical risks of intravenous thrombolytic therapy is critical to appropriate patient selection. The major risks can be classified into 5 major categories: intracranial hemorrhage, systemic hemorrhage, immunologic complications, hypotension, and myocardial rupture. Although theoretical concern exists about thromboembolic complications, they rarely occur. Although cardiac rhythm disturbances are somewhat more likely to occur at the time of reperfusion, the clinical significance of "reperfusion arrhythmias" is minimal. Intracranial hemorrhage, the most devastating complication, occurs in 0.2-1% of patients treated with thrombolytic therapy. Factors associated with incremental risk are now being identified from large clinical trials. Systemic hemorrhage is uncommon in patients without major vascular punctures and seldom leads to serious adverse outcomes. Immunologic complications--including anaphylaxis, which is rare, and immune complex disease, which is more common--occur only with streptokinase or agents with a streptokinase moiety, including anistreplase (anisoylated plasminogen--streptokinase activator complex, APSAC). Hypotension, which can be managed easily in most patients, is also observed much more frequently with streptokinase and anistreplase. Myocardial rupture is increasingly being recognized as a possible complication of late thrombolysis. A proper perspective on clinical risk can only be gained in the context of potential benefit of therapy. In many cases individual patients considered to be at highest risk for complications also stand to gain the most from treatment. Many of the questions raised by currently available data about bleeding risk are being addressed in the ongoing Global Utilization of t-PA and Streptokinase (GUSTO) Trial. A paradigm for considering this decision making problem is presented.

Pitfalls in the determination of absolute dimensions using angiographic catheters as calibration devices in quantitative angiography.

Using catheter outer diameter as a scaling device, quantitative coronary arteriography allows the precise and objective measurement of change in absolute dimensions of coronary arteries after mechanical or pharmacologic intervention. Because of variable density in the wall of the catheter, automated systems might vary in the determination of the outer catheter diameter. To examine this premise, catheters in a variety of French sizes from 6 manufacturers were injected with radiographic contrast and used as scaling devices for arterial phantoms of known geometric dimension. Radiographic diameters of the catheters were determined by applying the quantitative coronary arteriographic algorithm to the catheters using a calibration grid in the same field of view. The varying composition of the catheters resulted in differing x-ray attenuation and, subsequently, automated edge-detection algorithms varied widely in determining the actual catheter diameter to be used as a scaling factor. For instance, a Lucite "artery" with a minimal luminal diameter of 1.50 mm (image calibrated using the micrometer-determined outside diameter of a Baxter 8Fr guiding catheter) resulted in a quantitative angiographic diameter of 2.03 mm (overestimation by 35%). If the diameter of a similar size Shiley catheter was used to calibrate the image, a luminal diameter of 1.60 mm was determined: a difference of 0.43 mm based solely on differences in scaling catheter attenuation. These data suggest that a specific "fingerprint" for each catheter material and catheter French size exists, rendering generalizations about catheter size questionable. These observations are important for quantitative angiography where many brands and sizes of angiographic catheters are being used clinically.(ABSTRACT TRUNCATED AT 250 WORDS)

Restenosis after coronary angioplasty: an overview.

Despite substantial basic and clinical efforts to address the problem of restenosis after percutaneous coronary intervention, effective preventive therapies have not yet been developed. Nevertheless, the accumulated information has provided much insight into the process of restenosis in addition to allowing standards to be developed for adequate clinical trials. The pathophysiology of restenosis increasingly appears to be distinct from that of primary atherosclerosis. Restenosis involves elastic recoil, incorporation of thrombus into the lesion and fibrocellular proliferation in varying degrees in different patients. Lack of an animal model that satisfactorily mimics restenosis is a major impediment to further understanding of the process. Clinical studies are hampered by difficulties in finding a single unifying definition of restenosis and by variable methods of reporting follow-up. Reporting of clinical outcomes of all patients in angiographic substudies would allow a more satisfactory interpretation of the results of clinical trials. Current noninvasive test results are not accurate enough to substitute for angiographic and clinical outcome data in intervention trials. In the majority of observational studies, only diabetes and unstable angina have emerged as consistently associated with restenosis; whereas most of the standard risk factors for atherosclerosis have a less consistent relation. Disappointingly, the new atherectomy and laser technologies have not affected restenosis rates. The one possible exception is coronary stenting, as a result of the larger luminal diameter achieved by the placement of the stent. In conclusion, although substantial continued effort is necessary to explore the basic aspects of cellular proliferation and mechanical alteration of atherosclerotic vessels, attention to the principles of clinical trials and observation are required to detect the impact of risk factors and interventions on the multifactorial problem of restenosis. Adequate sample sizes, collection of clinical and angiographic outcomes and factorial study designs hold promise for unraveling this important limitation of percutaneous intervention.

The utility of echocardiography in the diagnostic strategy of postinfarction ventricular septal rupture: a comparison of two-dimensional echocardiography versus Doppler color flow imaging.

The diagnostic accuracy of Doppler color flow imaging in the diagnosis of postinfarction ventricular septal defects has not been established. In this study, 43 patients with unexplained hypotension or a new murmur in the periinfarct period were evaluated with conventional two-dimensional echocardiography and Doppler color flow imaging. The presence of a ventricular septal defect was confirmed by oximetry, ventriculography, operative repair, or autopsy in each case. Both two-dimensional and Doppler color flow imaging were 100% specific in excluding a ventricular septal defect. Doppler color flow imaging correctly identified the 12 confirmed ventricular septal defects in this study (100% sensitivity), whereas any combination of two-dimensional criteria only correctly identified seven (58% sensitive) (p less than 0.05). Doppler color flow imaging is superior to conventional two-dimensional imaging in the diagnosis of a postinfarction ventricular septal defect. In addition, Doppler color flow imaging localized the septal defect, and thus guided therapy and technique for repair. Carefully performed Doppler color flow examination can exclude or result in the rapid diagnosis of a ventricular septal defect, which eliminates the need for further time-consuming confirmatory testing.