Perioperative Assessment and Management of Risk from Coronary Artery Disease

  1. Valerie A. Palda, MD, MSc; and
  2. Allan S. Detsky, MD, PhD
  1. From the University of Toronto, St. Michael's Hospital, Mount Sinai Hospital, and the Toronto Hospital, Toronto, Ontario, Canada. Acknowledgment: The authors thank the Clinical Efficacy Assessment Subcommittee, especially Drs. D. Kent and G. Friesinger, for thoughtful review and comments. Grant Support: In part by Ontario Ministry of Health Fellowship 04874 (Dr. Palda), a University of Toronto Fellowship (Dr. Palda), National Health Research Scholar award 6606-2849-48 from Health and Welfare Canada (Dr. Detsky), and a grant from the American College of Physicians. Requests for Reprints: Valerie A. Palda, MD, 4-151, St. Michael's Hospital, 30 Bond Street, Toronto, Ontario M5B 1W8, Canada. Current Author Addresses: Dr. Palda: 4-151, St. Michael's Hospital, 30 Bond Street, Toronto, Ontario M5B 1W8, Canada.
     
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    Abstract

    Purpose: To summarize available evidence on preoperative cardiac risk stratification so that the internist may 1) use clinical and electrocardiographic findings to stratify a patient's perioperative risk for myocardial infarction and death; 2) decide which tests provide useful additional risk-related information; and 3) understand the benefits, risks, and evidence surrounding the decision to undertake coronary revascularization before elective noncardiac surgery.

    Data Sources: A MEDLINE search and review of the reference lists of identified articles. Sensitivities, specificities, and likelihood ratios for diagnostic tests were calculated, and a quality rating for study methods was applied.

    Data Extraction: Myocardial infarction and mortality were the major outcomes considered, and a quality rating for study methods was applied.

    Data Synthesis: Clinical and electrocardiographic findings, organized by multivariate prediction indices, accurately identify patients as having low, intermediate, or high risk for myocardial infarction or death. Pharmacologic stress imaging with thallium or echocardiography probably improves risk stratification for intermediate-risk patients having vascular surgery. These tests have not been shown to be effective prognostic indicators for patients having nonvascular surgery. No studies of angiography for risk prediction have been reported. Decision analyses and retrospective series suggest that the risks incurred by doing coronary angiography and revascularization before elective surgery outweigh the benefits. Prospective, controlled studies of coronary revascularization are lacking. Evidence from a randomized, controlled trial has shown a survival benefit with the perioperative use of β-blockers in patients at risk for coronary artery disease.

    Conclusions: Evaluation of all surgical patients by use of clinical indices is recommended. Low-risk patients need no further evaluation before surgery. High-risk patients need optimal management of their high-risk problems, including (if appropriate) β-blocker use, and may need to have their elective procedures canceled. Intermediate-risk patients probably benefit from further noninvasive stress testing, especially if they are having vascular surgery. Further clinical trials are needed for most areas of concern.

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    1. Introduction

    1.1 Perspective on the Perioperative Literature

    Clinicians frequently need to evaluate the perioperative risk status of their patients. Members of the American College of Physicians recently rated perioperative assessment as a “top ten” topic in need of guideline development [1]. The demand for guidance in the perioperative evaluation and management of patients probably reflects an increasing use of surgical procedures in older patients, the availability of multiple technologies with which to evaluate risk, an abundant but generally poor-quality literature evaluating those technologies, and confusion surrounding the goals of perioperative assessment. The literature on noninvasive risk stratification has concentrated on patients undergoing vascular surgery; these patients, because of their higher risk for perioperative cardiac events, may not be representative of the majority of patients (>90%) having major noncardiac surgery. New studies of thallium imaging, stress echocardiography, and perioperative management have prompted a reevaluation of an earlier quantitative review of the tools available for risk stratification [2]. Guidelines have recently been published by the American Heart Association and others [3-5].

    1.2 Purpose of This Review

    A successful strategy for diagnosis and management reduces perioperative (short-term) risk and coincidentally uses the evaluation done at the time of the operation as an opportunity to address the patient's long-term risk from coronary artery disease. Noninvasive tests may provide either diagnostic information (by detecting coronary artery disease) or prognostic information (by predicting risk). This paper primarily reviews the prognostic ability of available clinical and noninvasive tests to detect the perioperative (short-term) risk for cardiac illness and death among patients scheduled for noncardiac surgery. The literature on perioperative management intended to reduce the occurrence of cardiac events is also addressed. Noncoronary cardiac evaluation and management remain largely unstudied and are not discussed here. Noncardiac complications (such as stroke, pneumonia, renal failure, and deep venous thrombosis), although important, are beyond the scope of this review.

    1.3 Burden of Illness

    In 1988, more than 25 million patients in the United States had noncardiac surgery [6]. In 1990, Mangano estimated that 50 000 patients have postoperative myocardial infarctions and 20 000 patients die of these events annually [6]. In a recent report from a surgical database of 83 958 U.S. veterans (a generally older, male population), the overall 30-day postoperative mortality rate was 3.1% [7]. Cardiac complications occurred in 4.5% of patients (myocardial infarction occurred in 0.7%; cardiopulmonary resuscitation, in 1.5%; and pulmonary edema, in 2.3%), but noncardiac morbid complications occurred more frequently (respiratory complications occurred in 9.5% of patients, and renal failure requiring dialysis plus stroke plus bleeding requiring more than four units of blood occurred in 3.3%). In a substudy of this population, noncardiac events accounted for the majority of deaths [8]. A prospective study of 454 veterans also found that although death was commonly ascribed to cardiac causes (6 of 26 deaths [23%]), more than three fourths of in-hospital deaths were not due to cardiac problems (sepsis accounted for 6 of 26 deaths; pulmonary embolism accounted for 3 of 26, and other causes accounted for 11 of 26). Patients undergoing vascular surgery have a higher-than-average risk for postoperative myocardial infarction (3.1%) and death (5.2%) than do patients undergoing nonvascular surgery: They have a high prevalence of asymptomatic coronary artery disease (approximately 60%), and vascular surgery itself is independently predictive of risk [9, 10].

    1.4 Risks and Benefits of Perioperative Risk Stratification

    If successful, cardiac risk stratification separates patients into various risk categories so that their management can be tailored to their needs. Low-risk patients may be spared further testing, and postoperative management may be changed for patients at higher risk [2, 11]. The goal of risk stratification is to reduce overall mortality and morbidity. Clarification of risk status allows the clinician to provide better informed consent. From a societal perspective, reducing perioperative complications and avoiding unnecessary testing could result in substantial cost savings. The major harms of stratification arise from the use of potentially unnecessary preoperative testing and the consequent possibility of ineffective or harmful interventions. Harm may also result from delay of the planned noncardiac surgery.

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    2. Methods

    2.1 Values in the Interpretation of Medical Evidence

    This background paper and the accompanying guidelines [12] have been reviewed by using the American College of Physicians Clinical Efficacy Assessment process, which includes input from subcommittee review as well as multiple external reviews. The goals of the subcommittee include 1) the use of an evidence-based approach to grading the quality of data and 2) making explicit the perspectives and value judgments that underlie specific recommendations [13]. Recommendations are made on the basis of the strongest available evidence. If evidence is insufficient, recommendations, in general, are withheld. The prevailing view of the authors and subcommittee members is that the overall benefit for a diagnostic or treatment intervention must be demonstrated, particularly if the intervention is risky, before the intervention is recommended. We consider overall benefit or harm in terms of mortality and permanent morbidity (for example, myocardial infarction) to be more relevant end points than intermediate outcomes, such as transient arrhythmia and silent ischemia. In the absence of any perioperative data, we refer the reader to strategies from the nonsurgical literature.

    The purpose of this paper is to 1) summarize and grade the available evidence for perioperative testing and management strategies [and, in so doing, to highlight areas in which practice is based on sound evidence and areas in which evidence is lacking]; 2) provide recommendations for the use of these strategies where strong evidence exists; and 3) emphasize, where evidence is weak or nonexistent, the key elements of the diagnostic or therapeutic decision so that the clinician and the patient can decide on the optimal strategy.

    2.2 Search Strategy

    A MEDLINE search was conducted to find relevant English-language articles reporting on clinical studies published between 1977 and 1 May 1996. We used the Medical Subject Heading terms pre, peri and post-operative complications, pre-, peri- and post-operative care, heart disease, surgery, ± myocardial ischemia, ± risk factors, and excluding the term cardiac surgery. In addition, a manual search was done of the references found in identified articles, and references provided by experts were considered. Abstracts were included to minimize publication bias. All studies of perioperative management were considered.

    2.3 Exclusion Criteria

    Studies related to clinical and noninvasive test evaluations were excluded if they were beyond the scope of this review (that is, those related to covered noncardiac outcomes, pediatrics, quality of life, postoperative functional status, cost-effectiveness, or patient preferences) or if the data were presented in a form that did not allow the calculation of sensitivity and specificity.

    2.4 Outcome Variables

    Myocardial infarction and cardiac death were chosen as outcomes because they were consistently reported in studies, because the defining criteria for these events were often stated (a feature that improved comparability and objectivity), and because these events represent irreversible complications. Other outcomes are presented only if the data did not permit independent calculations of rates of myocardial infarction and cardiac death. Clinical evaluation refers to history, physical examination, laboratory values, and the electrocardiogram. Short-term refers to complications arising early in the postoperative period (0 to 30 days) or complications reasonably attributable to the surgery. Long-term generally refers to complications arising 30 days to 10 years after surgery.

    2.5 Assessment of Test Accuracy Using Likelihood Ratios

    Data were analyzed to determine pretest probabilities, sensitivities, specificities, likelihood ratios, and post-test probabilities. The pretest probability is the risk for development of cardiac complications after surgery in the entire study group, and it varies depending on the population studied. To convey the degree of added information provided by a particular test, the likelihood ratio of the test is used to revise the pretest probability to a predicted post-test probability for a particular patient either by increasing risk (likelihood ratio > 1) or decreasing it (likelihood ratio < 1) [14]. Clinically meaningful likelihood ratios, which indicate a test with good discrimination, are very low (<0.2), suggesting that the chance for a complication is minimal, or very high (>10), suggesting that the chance for a complication are high [14]. When a test has dichotomous results, the likelihood ratio is reported as the likelihood ratio for a positive test result or the likelihood ratio for a negative test result. Alternately, likelihood ratios may have more than one abnormal level; for example, they may be negative, indeterminate, and strongly positive. This is helpful with such tests as the clinical indices of risk, for which the likelihood ratio will be reported for each level.

    2.6 Estimation of Study Quality

    For studies of clinical and noninvasive test evaluation, criteria were developed to assess methodologic quality. These assessments permit studies to be divided and classified as strong, fair, or weak. Qualitative assessment considered, in order of importance, study design, selection of the patient sample, blinding to test results and outcomes, and number of patients. Studies were considered to be of strong quality if they prospectively evaluated unselected, consecutive patients; if they were double blinded (if the test interpreter was blinded to outcome and the clinician was blinded to the test results); and if they included 100 or more patients. Studies considered to be of fair quality prospectively evaluated unselected, consecutive patients; used single blinding or no blinding; and enrolled fewer than 100 patients. Studies considered to be of weak quality did not meet the criteria for fair quality, usually because they had retrospective study designs. Studies of management were few; for these studies, the features considered to be important in qualitative assessment included randomization, examination of clinical rather than surrogate end points, and use of controls.

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    3. Perioperative Risk Prediction: Clinical Predictors of Risk

    3.1 Previous Cardiac Evaluation and Treatment

    Observational retrospective evidence indicates that previous coronary artery bypass graft surgery, previous percutaneous transluminal coronary angioplasty, or favorable angiography results predict a low risk for adverse perioperative cardiac events. This risk is similar to that in patients without clinically significant coronary artery disease [9, 15-27]. Although the time between coronary revascularization and noncardiac surgery in these reports ranges from none to 10 years, the duration of the protective effect of coronary artery bypass graft surgery has not been examined. No studies directly assessing the predictive effect of previous negative noninvasive test results were found.

    3.2 Univariate Predictors of Risk

    Many recent studies with large sample sizes and multivariate analysis of results have supported definite coronary artery disease (history of myocardial infarction, angina pectoris, ischemic ST-segment changes on the electrocardiogram) and evidence of congestive heart failure as independent predictors of perioperative cardiac events [10, 28-35]. The timing of the myocardial infarction may be important: Patients who undergo surgery within 3 months of a myocardial infarction have considerably higher rates of reinfarction (27%) than do patients who undergo surgery 3 to 6 months and more than 6 months after infarction (11% and 4%, respectively) [36]. However, these data are from the prethrombolytic era and may be less applicable today.

    3.3 The American Society of Anesthesiologists Score

    The American Society of Anesthesiologists (ASA) score was the first clinical index developed to predict risk [37]. Although it is subjective, it has been found to be a sensitive predictor of death in very large numbers of patients (>100 000) (ASA class I, likelihood ratio close to 0; ASA class IV or V, likelihood ratio ≥20) [37-40]) and of major nonfatal complications [38, 41, 42]. The ASA score performs less well than other clinical risk indices in predicting cardiac complications [29, 43].

    3.4 Multivariate Cardiac Risk Indices

    The original Cardiac Risk Index was the first validated multivariate model developed to predict cardiac complications in a general surgical population [29]. Though univariate and subsequent multivariate stepwise discriminant analysis, nine statistically significant and clinically meaningful risk factors were identified and weighted. Scores were assigned to each variable according to its weight in the model, and a risk index for cardiac death and “life-threatening” complications (myocardial infarction, pulmonary edema, and ventricular tachycardia) was developed. The higher the score, the higher the predicted risk; scores range from class I (low risk) to class IV (high risk). Patients with angina were excluded from this early study.

    3.5 The Modified Cardiac Risk Index

    The original Cardiac Risk Index was modified by Detsky and colleagues [28], who added the important new variable of significant angina (as well as the variable of remote myocardial infarction) and simplified the scoring system into three classes of risk. Outcome observers were blinded to the score when the modified index was validated on a separate group composed of patients undergoing vascular surgery and patients undergoing nonvascular surgery. The modified Cardiac Risk Index improved predictive accuracy among higher-risk patients (likelihood ratio, 10.60 for class III) (Table 1 and Table 5).

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    Table 1. Use of Clinical Risk Indices To Predict Postoperative Cardiac End Points*
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    Table 5. Table 1 Continued

    3.6 Other Scores

    Many weak-quality and fair-quality studies have proposed other multivariate clinical models, but these have involved few patients or remain unvalidated [8, 10, 30, 50-53]. The best-designed and largest of these studies prospectively developed a multivariate score on more than 9000 veterans undergoing general surgery (fair evidence) [8]. In contrast to other studies [28-3135, 54-56], this study did not show hypertension to be an independent predictor of events; it showed elevated creatinine level (>398 µmol/L or >4.5 mg/dL) to be a very strong predictor of events; and it showed that elevated glucose level (>11 mmol/L or >200 mg/dL), rather than the presence of diabetes, predicted postoperative risk. This index has not been validated in other populations.

    3.7 Strengths and Weaknesses of Cardiac Risk Indices

    Many investigators have validated the ability of high Cardiac Risk Index or modified Cardiac Risk Index scores to predict high postoperative risk both in patients having vascular surgery and in patients having nonvascular surgery, but variable results have been obtained for low scores (fair and strong evidence) [28-32, 43-49] (Table 1 and Table 5). A significant proportion of postoperative events occurred in patients with low scores, both in patients having vascular surgery and in patients having nonvascular surgery; this highlights the inability of low clinical index scores to rule out postoperative risk. This may be because patients with low scores represent a diverse population with a wide range of risks.

    3.8 Refining Determination of Low-Risk Status

    The absence of any of the five factors in the clinical model developed by Eagle and colleagues (Table 2 and Table 6) [57] can identify patients undergoing vascular surgery who are at very low risk (0%) for cardiac events (0 factors: likelihood ratio, 0.00; 1 or 2 factors: likelihood ratio, 1.10; 3 factors: likelihood ratio, 6.66) [58]. Similarly, in a recent strong-quality study by Vanzetto and colleagues [59], the absence of any of eight clinical criteria predicted a risk for death of 0.8% and a risk for myocardial infarction of 1.6% in patients having vascular surgery (total event rate, 2.4%) (Table 2 and Table 6). The higher sensitivity demonstrated by the absence of these “low-risk” criteria is partly attributable to the lower cutoff values for symptoms (for example, the absence of any angina compared with the absence of severe angina in the modified Cardiac Risk Index). In two very large studies of registry-collected data [8, 10], U.S. veterans undergoing nonvascular surgery who had no clinical risk features had an even lower incidence of perioperative myocardial infarction (0% to 0.4%) (likelihood ratios, 0.00 to 0.12) (fair quality). A comparison of variables used in the multivariate scores is shown in Table 2 and Table 6.

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    Table 2. Comparison of Clinical Risk Indices*
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    Table 6. Table 2. Continued

    3.9 Functional Status

    The Duke Activity Status Index was developed to assess functional capacity in a manner that correlates with oxygen uptake by weighting questions according to the known metabolic cost of each activity [60]. Correlation of peak oxygen uptake was higher with the Duke Activity Status Index than with the Canadian Cardiovascular Society classification of angina or the Specific Activity Scale (Spearman correlation coefficients, 0.58, 0.49, and 0.30, respectively) (fair evidence) [60-62]. Studies of patients undergoing major noncardiac surgery have shown that severe limitation of activity (being bedridden or able to move only from bed to chair) (strong quality) [56] or inability to reach a target heart rate on bicycle ergometry (99 beats/min after 2 minutes) (fair quality) [43] predicts postoperative cardiac risk. The Cardiac Risk Index and modified Cardiac Risk Index also incorporate bedridden status into their scores [28, 29]. The Duke Activity Status Index has not been specifically tested in the perioperative setting, and it is not known whether formal evaluation of functional status adds risk information to that obtained from a clinical risk index.

    3.10 Risk Contributed by the Surgical Procedure

    Although not modifiable, the nature and circumstances of the planned operation influence the patient's postoperative risk. Urgent, prolonged (>5 hours), or hemodynamically stressful procedures, such as major vascular, intraabdominal, or intrathoracic operations, carry a greater risk for perioperative cardiac events [6-828, 29]. Peripheral vascular and orthopedic procedures carry the greatest risks (>13%), followed by abdominal or thoracic surgery (8%), head and neck, ophthalmic or prostate surgery (3%) [28]. These estimates may be high because the patients in the study from which these data were drawn were all referred for the possibility of cardiac risk.

    3.11 Summary

    All patients should initially be assessed by using the modified Cardiac Risk Index so that patients at high risk (10% to 15%) for postoperative cardiac events can be detected. For the remaining patients, obtaining information about “low-risk” variables will allow further clinical classification into low-risk (0% to 3%) and intermediate-risk (3% to 10%) groups. For a detailed summary of the recommendations, please see the “Clinical Assessment” section in the accompanying guideline.

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    4. Perioperative Risk Prediction: Noninvasive Tests

    4.1 Limitations of Noninvasive Tests

    Noninvasive tests available for further risk stratification include those that assess left ventricular function (radionuclide angiography), cardiac ischemia (exercise or pharmacologic stress testing and ambulatory electrocardiographic monitoring), or both (dobutamine stress echocardiography). A non-invasive test may be able to detect a cardiac abnormality, the presence of which does not necessarily predict increased risk. Rather than concentrating on the diagnostic characteristics of noninvasive tests, we focus on the predictive accuracy of these tests for subsequent clinical outcomes. Important variations in the interpretation of noninvasive test results have been documented [63-65]. These variations, as well as varying surveillance strategies for outcomes and outcome definitions and the heterogeneity of the populations studied, may account for the variable test accuracy seen for some screening methods [66]. Early reports (based on weak study methods) of the predictive accuracy of these tests have almost always been optimistic. As study quality has improved, the predictive ability of noninvasive testing has declined. Only studies with fair- or strong-quality methods are discussed in this review. Noninvasive testing may never be able to stratify patients fully because postoperative events probably have multifactorial causes. Tests done before surgery cannot account for every intra- and postoperative factor. For example, the perioperative period is a time of hypercoagulability, catecholamine surges, pain, and operative stresses, all of which may influence oxygen demand, and factors other than coronary stenosis (for example, anemia) that may influence oxygen supply, leading to myocardial ischemia [67].

    4.2 Evaluation of Left Ventricular Function

    Early, weak-quality studies of radionuclide angiography showed discriminating likelihood ratios but suffered from retrospective study designs, small sample sizes, and low event rates [68-73]. In later studies of weak or fair quality, investigators noted poorly predictive negative test results (likelihood ratios, 0.81 to 0.96 for normal ejection fraction) and poorly predictive positive test results (likelihood ratios, 1.41 to 6.24 for low ejection fraction) [33, 74-78]. The largest of these studies demonstrated the poorest performance characteristics for radionuclide angiography (fair evidence) [33]. In direct comparison with other noninvasive methods, radionuclide angiography has also performed poorly [75, 79, 80]. Transthoracic echocardiography, the other major method for assessing left ventricular ejection fraction, does not improve on the clinical examination in the prediction of postoperative myocardial infarction and cardiac death (strong evidence) [81].

    4.3 Exercise Stress Testing

    Exercise stress testing is a widely available and inexpensive method of screening for coronary artery disease [82]. A substantial proportion of patients with peripheral vascular disease (30% to 70%) cannot attain target heart rates and therefore cannot complete the testing adequately for diagnosis [83-85]. Other problems, such as degenerative knee or hip disease or previous stroke [86], can also impair walking ability. In patients who could perform the test, one small study of patients with vascular disease showed a predictive positive likelihood ratio of 4.83 (presence of ST-segment depression) and a predictive negative likelihood ratio of 0.00 (absence of ST-segment depression) (fair evidence) [87]. Other, larger studies do not support these findings, showing poorly predictive positive likelihood ratios ranging from 1.30 to 2.56 and poorly predictive negative likelihood ratios ranging from 0.17 to 0.86 (two fair-quality studies of mixed vascular and non-vascular surgery [88, 89] and one weak-quality and two fair-quality studies of vascular surgery [83-85]).

    4.4 Pharmacologic Stress Testing

    For patients who cannot exercise, artificially increasing myocardial perfusion by infusing dipyridamole followed by thallium imaging or increasing myocardial oxygen demand with dobutamine followed by echocardiography offers alternatives for detecting coronary ischemia. Normal scans show normal myocardial wall images or wall motion both at rest and at peak myocardial demand. Defects in myocardial images or abnormalities in wall motion seen at the time of peak demand are considered abnormal: “Fixed” defects continue to show decreased uptake, whereas “reversible” defects reveal improved flow in later resting images. Because reversible defects are more likely to indicate myocardium at risk, our calculations for sensitivity and specificity translate reversible defects into a positive test result and normal or fixed defects into a negative test result.

    4.4.1 Thallium Myocardial Imaging

    Of the various types of thallium imaging, dipyridamole-thallium imaging has been studied most often. Other types have been studied only in weak-quality studies [90-93] and are not discussed here. Of 57 studies of perioperative dipyridamole-thallium imaging [33, 46-4957, 59, 63-6575, 79, 84, 85, 94-136], 12 were excluded, most because the presentation of data precluded quantitative analysis [120-131]. In all, 28 distinct patient populations were identified for which end-point data could be calculated. Only 4 studies were prospective studies with fair-quality or strong-quality evidence ratings (Table 3), and all were done in patients having vascular surgery. The fair-quality studies by Mangano [68] and Baron and colleagues [33] suggested that a negative dipyridamole-thallium scan was not predictive (likelihood ratios close to 1), whereas the fair-quality study of Sachs and colleagues [111] and the strong-quality study of Vanzetto and associates [59] found negative dipyridamole-thallium scans to be predictive of low risk (likelihood ratios, 0.00 to 0.12). In the studies by Mangano and Baron and colleagues, the investigators prospectively enrolled consecutive patients undergoing vascular surgery. Assessing the value of dipyridamole-thallium imaging on this larger, lower-risk population may have masked the predictive value of dipyridamole-thallium imaging in the intermediate-risk patients. One strong study [59] showed that quantification of the extent of thallium redistribution was more predictive than dichotomous interpretation (positive/negative). This supports the results of earlier, weak-quality studies, which have suggested that increased risk discrimination is obtained from semiquantitative interpretation [46, 47, 100, 102, 110, 115, 133, 134, 136].

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    Table 3. Use of Dipyridamole-Thallium Redistribution To Predict Cardiac Death and Myocardial Infarction*

    In addition, the study by Vanzetto and associates [59] showed that dipyridamole-thallium imaging can add risk discrimination to that provided by the clinical evaluation alone (strong evidence) [59]. In this study, interpreters of test results were blinded to clinical outcome and outcome observers were blinded to test results. Clinicians did not, therefore, alter management because of results on thallium imaging. Of 517 unselected patients scheduled to have vascular surgery, 60 had surgery canceled for clinical reasons. Of the 457 patients who went to surgery, 134 had at least two of the following clinical risk factors: age greater than 70 years, history of myocardial infarction, history of angina, history of congestive heart failure, diabetes mellitus, hypertension with severe left ventricular hypertrophy, presence of Q-waves on an electrocardiogram, or ST-segment ischemic abnormalities on a resting electrocardiogram. Of these 134 patients, 9% had either cardiac death or myocardial infarction. Only these 134 intermediate-risk patients underwent dipyridamole-thallium imaging. A negative dipyridamole-thallium scan predicted very low risk (likelihood ratio, 0.12; post-test probability, 1%), and a positive dipyridamole-thallium scan indicated increased risk (likelihood ratio, 3.02; post-test probability, 23%).

    4.4.2 Pharmacologic Stress Echocardiography

    Stress echocardiography has the theoretical advantage of being able to assess both regional wall-motion abnormalities resulting from induced myocardial ischemia and left ventricular function. The most commonly studied method is dobutamine stress echocardiography [58, 137-142]. Strong-quality and fair-quality studies exist only for patients undergoing vascular surgery and suggest that dobutamine stress echocardiography has good predictive accuracy [58, 137, 140]. The strongest of these studies examined the incremental value of dobutamine stress echocardiography over clinical factors in predicting operative risk in 302 consecutive patients [58]. Dobutamine stress echocardiography did not add risk discrimination for patients with no clinical markers, according to the criteria of Eagle and colleagues [57], because no events occurred in this group. Dobutamine stress echocardiography did stratify patients who had one or two clinical markers. Patients with negative results on dobutamine stress echocardiography had a likelihood ratio of 0.00 (that is, they had no events), whereas patients with a positive result on dobutamine stress echocardiography had a likelihood ratio of 4.76. In patients with three or more clinical markers, a negative result on dobutamine stress echocardiography again ruled out events (likelihood ratio, 0.00) and a positive result increased the risk for adverse events (likelihood ratio, 3.00).

    4.4.3 Pharmacologic Stress Testing among Patients Having Nonvascular Surgery

    It would be desirable to have a noninvasive test for intermediate-risk patients undergoing nonvascular surgery that performs as well as dipyridamole-thallium imaging and dobutamine stress echocardiography in patients having vascular surgery. Unfortunately, all studies of dipyridamole-thallium imaging and dobutamine stress echocardiography in nonvascular patients are of weak quality. Four of the five published studies in this group show poor positive and negative likelihood ratios for dipyridamole-thallium imaging in the prediction of myocardial infarction and cardiac death [80, 95, 110, 114, 132]. The one study that has addressed the value of dobutamine stress echocardiography in a group composed both of patients having vascular surgery and patients having nonvascular surgery similarly revealed a poorly discriminating positive likelihood ratio [139]. Proceeding with dipyridamole-thallium imaging and dobutamine stress echocardiography in patients having nonvascular surgery carries the risk for minor morbidity, incurs the cost of testing, and may result in unnecessary downstream interventions [46, 63, 98-102, 136].

    4.5 Monitoring for Silent Ischemia

    Two methods of ambulatory electrocardiographic monitoring have been studied. Holter monitoring is widely available but requires manual interpretation [143]. Other investigators have used less widely available, small, portable electrocardiographic monitors with built-in microprocessors, which allow automated interpretation of ischemia [144-146]. A substantial proportion of patients (12% to 73%) cannot be studied because of resting electrocardiographic abnormalities that make interpretation of silent ischemia difficult [143-147]. Many investigators have assessed the ability of preoperative electrocardiographic monitoring to predict perioperative risk [118, 143-157]. Fair-quality and strong-quality studies are summarized in Table 4. The largest study by Mangano and colleagues [148], which included patients having general surgery and patients having vascular surgery, failed to show a screening benefit for preoperative monitoring using this technique (strong evidence). The other strong-quality study, which was done only on patients havig vascular surgery, showed both strong positive and strong negative likelihood ratios (Table 4) [147]. These two studies found different likelihood ratios for comparable patients having vascular surgery. Preoperative monitoring did not perform as well as dipyridamole-thallium imaging, although the two tests together provided more benefit than either test alone [118, 133] (weak and fair evidence). Intraoperative and postoperative ischemia seem to be more predictive of postoperative events [147, 148, 152-154]. Although not part of preoperative assessment, this information may help the clinician decide whether a patient needs close postoperative monitoring.

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    Table 4. Use of Preoperative Electrocardiographic Monitoring To Predict Cardiac Death and Myocardial Infarction*

    4.6 Cardiac Catheterization

    Cardiac catheterization has been recommended by some authors as a routine screening test in patients undergoing vascular surgery because these patients have a high prevalence of coronary artery disease [9]. Cardiac catheterization has been reported to carry a mortality rate of 0.01% to 0.5% and a rate of serious morbidity ranging from 0.03% to 0.25% [9, 158, 159]. The value of angiography as a risk predictor has not been reported.

    4.7 Summary

    Among patients undergoing vascular surgery who are clinically at intermediate risk, we recommend using dipyridamole-thallium imaging or dobutamine stress echocardiography to further clarify risk status. Dipyridamole-thallium imaging and dobutamine stress echocardiography do not clearly benefit patients undergoing vascular surgery who are clinically at low risk, and these tests do not add information for any patients (low-risk or intermediate-risk) undergoing nonvascular surgery. None of the other noninvasive tests have been found to reliably add risk prediction information either for patients undergoing vascular surgery or for those undergoing nonvascular surgery. For a detailed summary of the recommendations, please see the “Noninvasive Testing” section in the accompanying guidelines.

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    5. Management Strategies

    5.1 Impact of Stratification on Management

    Approximately 10% of patients will be considered to be at high surgical risk after clinical evaluation (fair and strong evidence) [8, 28]. Among unselected patients undergoing vascular surgery, an additional 9% to 20% may be reclassified as high-risk by noninvasive testing (strong evidence) [58, 59]. If approximately half of these patients have operable coronary artery disease [159], noninvasive testing could potentially identify an additional 5% to 10% of patients eligible for coronary bypass. We have no data for patients undergoing nonvascular surgery because no noninvasive test has been shown to reliably alter risk classification. Whether changing management in high-risk patients improves outcomes is reviewed for both coronary revascularization and medical therapies in sections 5.3 and 5.4, respectively.

    5.2 Emergency Situations

    Clinical judgment is always necessary in weighing the relative urgency of a patient's cardiac condition and noncardiac operative problem. Some patients require emergency noncardiac surgery and deferment of any consideration of coronary revascularization. At the other end of the spectrum, a small proportion of patients display clinical features indicating that their cardiac condition requires urgent attention. These features include decompensated congestive heart failure, life-threatening arrhythmia, and unstable coronary syndromes (recent myocardial infarction with evidence of important ischemic risk or unstable or severe angina).

    5.3 Coronary Revascularization

    In uncontrolled retrospective series, coronary revascularization among patients undergoing both vascular and nonvascular surgery has demonstrated a protective effect with respect to subsequent surgical risk [15-27119, 160]. The largest of these series, a retrospective analysis of 1600 patients from the Coronary Artery Surgery Study registry, revealed significant differences in mortality between patients who had previously undergone coronary artery bypass graft surgery (0.9%) and those who had not (2.4%) [17]. This did not account for the mortality resulting from the bypass surgery itself (2.3% overall for patients in the Coronary Artery Surgery Study registry).

    5.3.1 Short-Term Benefit of Coronary Revascularization

    For some patients, the upcoming noncardiac procedure carries a high cardiac risk but no other indication for coronary revascularization is present. Coronary revascularization can be undertaken prophylactically in these patients with the goal of reducing the short-term (operative) mortality of the noncardiac procedure. Seeger and colleagues [104] compared prospectively enrolled patients undergoing thallium imaging before vascular surgery (to determine who should receive angiography and bypass) with historical controls who had coronary revascularization on the basis of clinical grounds (before the introduction of thallium imaging). In this study, performing a stress thallium test increased the frequency of coronary revascularization procedures (4.1% before introduction of thallium and 14.7% after introduction of thallium) but did not seem to improve outcomes (weak evidence) [104].

    Two decision analyses have addressed the short-term benefit of prophylactic coronary artery bypass surgery among patients with vascular disease [159, 161]. Mason and associates [159] found that for a patient with a positive dipyridamole-thallium scan, proceeding to vascular surgery with close monitoring of cardiac status led to better results for all outcomes than did a strategy of coronary angiography followed by revascularization. Fleisher and co-workers [161] addressed whether patients undergoing vascular surgery should proceed directly to surgery or undergo dipyridamole-thallium imaging. Their base-case scenario also favored proceeding directly to surgery without testing. Perhaps the most important finding in both of these analyses was that the decision to test or revascularize or proceed directly to surgery was sensitive to three probabilities: the patient's prior probability of coronary artery disease, the risk of revascularization, and the risk of the vascular operation. These analyses were performed in a population of patients having vascular surgery. The benefit:harm ratio of prophylactic coronary revascularization may be even less favorable among patients undergoing nonvascular surgery because these patients generally have a lower prior probability for cardiac events [10].

    5.3.2 Long-Term Benefit of Coronary Revascularization

    Other patients have an indication for coronary revascularization that is independent of the upcoming noncardiac procedure. In these patients, coronary revascularization is done to reduce long-term mortality and may also reduce postoperative cardiac risk if it is done before the noncardiac surgical procedure. Controlled trials have shown that in certain patients, revascularization improves long-term symptoms and prolongs survival. These patients include those with unstable angina refractory to medication, those with left main coronary artery stenosis, those with triple-vessel disease and impaired left ventricular function, and those with the possibility of two-vessel coronary artery disease with proximal left anterior descending involvement (and left ventricular dysfunction), as outlined in the American College of Cardiology/American Heart Association guidelines on coronary artery bypass graft surgery [162]. In some of these patients, such noninvasive tests as exercise stress testing (with or without thallium) and pharmacologic stress testing (for those unable to exercise) may be able to identify anatomic patterns that are indicators for coronary artery bypass grafting [82, 163]. The opportunity to address other therapies of proven benefit in patients with known coronary artery disease also arises at the time of the operation. These therapies include control of hypertension, aspirin, cessation of smoking, cholesterol reduction, and angiotensin-converting enzyme inhibition in patients with left ventricular dysfunction.

    5.3.3 Other Methods of Coronary Reperfusion

    Only small, retrospective case series without controls have reported results of preoperative percutaneous transluminal coronary angioplasty [15, 16, 164, 165]. It is therefore recommended that consideration of percutaneous transluminal coronary angioplasty be guided by the evidence available in the nonoperative setting [166]. Although coronary stent placement is increasingly popular, prospective evaluations of this technology in the perioperative setting have not yet appeared.

    5.4 Therapies Other Than Coronary Revascularization

    In randomized trials, no one anesthetic agent has been shown to be superior in preventing myocardial infarction or reducing mortality rates [167-171]. A systematic review of the use of pulmonary artery catheterization has been published: In 1993, the American Society of Anesthesiologists examined the available evidence demonstrating benefit and harm in pulmonary artery catheterization [172]. The evidence about perioperative pulmonary artery catheterization monitoring was of weak and fair quality, and study findings were inconsistent. On the basis of “expert opinion, informed by scientific evidence,” the document recommended that pulmonary artery catheterization be used only in situations that put the patient at high risk for hemodynamic compromise (patient-, procedure-, and practice-related). Controlled studies examining the benefits of perioperative medical therapies have, for the most part, used surrogate end points (such as postoperative ischemia) or transient cardiovascular complications (such as heart failure or arrhythmias) [173-177]. In these studies, prophylactic nitrate, calcium-channel blocker, or digitalis administration has not been shown to reduce the frequency of even surrogate outcomes [173-177]. The use of β-blockers is reviewed below.

    Authors Addendum: Since this background paper and its accompanying guidelines were reviewed by the American College of Physicians, an important publication that we believe should alter current practice has emerged. In December 1996, the Multicenter Study of Perioperative Ischemia Research Group demonstrated in 200 patients that perioperative β-blockade could substantially reduce mortality rates and rates of nonfatal cardiac events [178]. Among patients who had or were at risk for coronary artery disease and who were undergoing noncardiac surgery (both vascular and nonvascular), mortality rates and rates of cardiovascular events were significantly reduced by the administration of atenolol throughout hospitalization (8% absolute reduction in mortality rates at 6 months [P < 0.001]; 15% absolute reduction in rates of combined myocardial infarction, unstable angina, or congestive heart failure requiring hospital admission and clinical diagnosis and treatment; myocardial revascularization; and death [P < 0.001]). Patients deemed to be “at risk” for coronary artery disease in this study met at least two of the following criteria: 65 years of age or older, hypertension, current smoking, serum cholesterol concentration 240 mg/dL (6.2 mmol/L) or more, and diabetes mellitus. Atenolol was well tolerated. This trial is the only randomized study that has examined the effect of β-blockers on clinical end points. The results are consistent with those of earlier randomized trials demonstrating reduced intraoperative blood pressure and myocardial ischemia with β-blocker therapy and of nonrandomized, controlled studies showing a decline in rates of post-operative myocardial infarction or death [179-181]. We (the authors) believe that this trial is sufficiently convincing, in the absence of contradictory evidence, that it is now appropriate to give atenolol to patients who meet the above criteria, as long as no serious contraindications [such as asthma] are present. Important questions to be answered in future β-blocker trials are 1) whether previous revascularization negates the benefit of β-blockers, 2) which subgroups benefit most from β-blockade, and 3) whether perioperative administration of β-blockers reduces early (1- to 3-month) postoperative mortality rates (not studied in this trial).

    5.5 Summary

    Using coronary revascularization as a preventive step to reduce cardiac risk before noncardiac surgery has not been shown to reduce short-term mortality. Determination of whether the patient is a candidate for coronary revascularization should therefore be made on the same clinical grounds that govern the need for coronary revascularization in nonoperative settings. In the absence of an independent clinical need for coronary revascularization, the patient should proceed to surgery without further cardiac investigation. Patients with documented or significant risk factors for coronary artery disease should receive perioperative β-blockade. For a detailed summary of the recommendations, please see the “Management Strategies” section in the accompanying guidelines.

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    6. Cardiac Conditions Other Than Coronary Disease

    Few studies have looked at the implications of noncoronary cardiac disease on surgical risk. Aortic stenosis is the only valvular disease predictive of death, and it is included in the Cardiac Risk Index and modified Cardiac Risk Index [28, 29]. The optimal timing of aortic valve repair (if appropriate) relative to noncardiac surgery is unknown. Diseased or artificial heart valves carry the risk for perioperative infection. In this connection, the reader is referred to the American Heart Association's published guidelines on the prevention of bacterial endocarditis [182]. Arrhythmias add to the Cardiac Risk Index and modified Cardiac Risk Index scores [28, 29]. Perioperative treatment of supraventricular tachycardias has not been found to be beneficial [183]. Studies of the perioperative treatment of hypertension have measured only surrogate physiologic outcomes, such as intraoperative blood pressure fluctuations and ischemia [184, 185]. One cardiomyopathy case series without controls was identified [186]. Adults with congenital heart disease face special risks because of their altered anatomy, oxygenation, and hemostasis [187].

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    7. Areas of Future Research

    The differences among medical societies in recommendations about perioperative cardiac evaluation stem largely from differences in the values used to interpret weak or conflicting medical evidence. Further well-designed studies are needed if we are to determine which noninvasive tests can improve risk stratification among intermediate-risk patients undergoing nonvascular surgery (90% of patients having noncardiac surgery). This research should strive to overcome biases that have limited previous results by evaluating unselected patients from both secondary and tertiary settings in a prospective, blinded manner. These studies should also determine the proportion of patients in which noninvasive testing and subsequent selective angiography and coronary revascularization could reduce the frequency of postoperative cardiac events. Study of the optimal stratification strategy should consider not only therapeutic benefit but also the cost-effectiveness of different pathways, given the high prevalence of this problem and the potentially large financial implications of screening numerous patients.

    Pharmacologic thallium imaging, stress echocardiography, and monitoring particularly need further exploration. A randomized, controlled trial is needed that compares clinical assessment alone with clinical assessment plus noninvasive testing. The randomized trial design is feasible and ethical in this area because the literature has failed to adequately show the benefit of noninvasive testing, either prognostically or therapeutically, in the great majority of patients. Another important question that remains unanswered is the circumstances under which coronary reperfusion, done either through coronary artery bypass graft surgery, percutaneous transluminal coronary angioplasty, or coronary stenting, is beneficial before the noncardiac surgery. Finally, further randomized trials that address permanent clinical end points, such as rates of myocardial infarction, cardiac death, and overall death, are needed to assess the benefits of therapeutic strategies used to decrease postoperative mortality and morbidity. Surrogate end points are insufficient to justify potentially dangerous interventions. When improvements in the mortality rate are minimal, as may be the case for perioperative management, quality of life, functional status, patient preferences, and cost considerations gain prominence and should be included in outcome assessment.

    Dr. Detsky: Suite 427, Mount Sinai Hospital, 600 University Avenue, Toronto, Ontario M5G 1X5, Canada.

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