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Ann Thorac Surg 1998;65:383-389
© 1998 The Society of Thoracic Surgeons

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Original Articles: Cardiovascular

Increased Risk and Decreased Morbidity of Coronary Artery Bypass Grafting Between 1986 and 1994

Department of Cardiothoracic Anesthesiology The Cleveland Clinic Foundation, Cleveland, Ohio, USA
Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
the Medical Information Systems Division, The Cleveland Clinic Foundation, Cleveland, Ohio, USA

Accepted for publication July 18, 1997.

Dr Estafanous, Department of Cardiothoracic Anesthesiology, The Cleveland Clinic Foundation, Mail Code: G30, 9500 Euclid Ave, Cleveland, OH 44195.

	Abstract

Top Abstract Introduction Material and Methods Results Comment References

 
Background. The collective impact of advances in medical, surgical, and anesthetic care on the characteristics and outcomes of patients who undergo coronary artery bypass grafting was assessed.

Methods. We compared the demographic and clinical characteristics, preoperative risk factors, morbidity, and mortality of two groups of patients who underwent coronary artery bypass grafting in isolation or in combination with other procedures between July 1, 1986, and June 30, 1988 (group 1, n = 5,051), and between January 1, 1993, and March 31, 1994 (group 2, n = 2,793). The patients were stratified according to their preoperative risk level. Outcome measures consisted of changes in preoperative risk categories; hospital mortality rates; overall and risk-adjusted major cardiac, neurologic, pulmonary, renal, and septic morbidity rates; and intensive care unit length of stay.

Results. Changes in the distribution of risk categories, from a median of 2 to 4 on a 9-point scale (p < 0.001), indicated that patients in group 2 were at significantly higher risk than those in group 1. The risk-adjusted mortality rate did not change (2.8% to 2.9%; p = 0.15), but the risk-adjusted morbidity rate decreased significantly (14.5% to 8.8%; p < 0.001).

Conclusions. At our institution, patients who undergo coronary artery bypass grafting are now at greater preoperative risk at the time of hospital admission. However, their morbidity rate is significantly lower and their mortality rate is unchanged, results that we attribute to the collective impact of changes in our medical and surgical procedures.

	Introduction

Top Abstract Introduction Material and Methods Results Comment References

 
During the past decade, improved medical treatment, aggressive thrombolytic therapy, and angiographic interventions have changed the profile of patients who undergo coronary artery bypass grafting. Patients who are referred for cardiac operations today are likely to be older and at higher surgical risk [1] [2]. However, advances in surgical techniques, anesthesia management, and postoperative care have offset the risks of operating on sicker patients and have improved surgical outcomes [3] [4] [5].

To assess the impact of these changes at our institution, we sought to identify differences between two groups of patients who underwent coronary artery bypass grafting during two separate periods, at the beginning and end of an 8-year span and separated by 5 years. In this study, we describe two groups, totaling 7,844 patients, using data from our Cardiovascular Anesthesia Registry. We compare the changes between these two groups in terms of preoperative risk categories, overall and risk-adjusted morbidity and mortality rates, and intensive care unit (ICU) length of stay, and we comment on the factors that may explain these changes.

	Material and Methods

Top Abstract Introduction Material and Methods Results Comment References

 
The Cardiovascular Anesthesia Registry
The Cardiovascular Anesthesia Registry was established in 1982 to permit detailed analyses of patient characteristics and outcomes. The registry contains prospectively collected data on all adult patients who undergo cardiac operations at our institution.

The registry is maintained by one full-time database manager and statistician who supervises all data entry and extraction, one full-time database coordinator who is responsible for data entry and verification, and three data abstractors (two nurses and a respiratory therapist, each with between 10 and 15 years of ICU experience) who, during the hospitalization, abstract data daily from the medical record for entry into the Registry. Data are collected, entered, verified, and extracted according to strict written protocols.

Patients
All patients included in the present study had severe coronary atherosclerosis and underwent coronary artery bypass grafting, either alone or in combination with other surgical procedures, such as heart valve operations or carotid endarterectomy. Two groups of patients were identified for the study. Group 1 underwent operation between July 1, 1986 and June 30, 1988 (n = 5,051), and group 2 underwent operation between January 1, 1993 and March 31, 1994 (n = 2,793).

Three high-risk subgroups also were identified for analysis: patients who underwent emergency operation, patients who underwent cardiac reoperation, and patients who were 75 years of age or older. Indications for emergency operation were unstable angina, unstable hemodynamics that could not be controlled medically (ie, in patients with complications from percutaneous transluminal coronary angioplasty or other events in the cardiac catheterization laboratory), and ischemic valvular dysfunction. Severe left ventricular dysfunction was defined as an ejection fraction of less than 0.30. No adjustments were made for patients who fell into two or more of these categories.

Preoperative risk was determined on the basis of The Cleveland Clinic Risk Score [6]. This risk score was developed in 1988 using the patients in group 1 and was applied in the present analysis to group 2 to compare the two groups. The risk score is the sum of 13 weighted preoperative risk factors and is described in the original study [6]. Total scores range from 0 to 31. Risk scores of 0 through 6 correspond to seven risk categories; scores of 7, 8, and 9 are combined into an eighth category; and scores of 10 and above are combined into a ninth category, as a result of a low number of patients with these scores in the original cohort. We did not control for the effects of individual surgeons and anesthesiologists because individuals from either discipline were not associated with different or additional risk in either the original or the current study [6].

Outcome Variables
Several outcome variables were assessed. Mortality was defined as an in-hospital death that occurred during the principal hospitalization and was identified further as either intraoperative or postoperative. Morbidity rates were calculated for the following complications:

Myocardial infarction was defined as new Q waves, at least 40 ms long, and an R wave of 25% or more plus a creatinine phosphokinase myocardial band of 50 IU or greater or an aspartate aminotransferase level of 80 U/L or greater.

Other cardiac complications were defined as any low-output syndrome that required an intraaortic balloon pump or a ventricular assist device.

Prolonged ventilatory support was defined as the use of mechanical ventilatory support for a total of 3 days or more.

Central nervous system complications were defined as a focal brain lesion confirmed by clinical findings, computed tomographic scan, or both; diffuse encephalopathy with more than 24 hours of severely altered mental status; or the unexplained failure to awaken within 24 hours after operation.

Renal complications were defined as oliguria or anuric renal failure (urine output of less than 400 mL in a 24-hour period, institution of dialysis or ultrafiltration, or a combination of these factors).

Serious infection was defined as culture-proven pneumonia, mediastinitis, wound infection, or septicemia with appropriate clinical findings.

Patients who had multiple complications were included in the counts for each complication. No adjustment was made for multiple complications or for potential interactions among complications.

Length of ICU stay was calculated from the dates of admission and discharge and is analyzed as an ordinal variable indicated by the percentage of patients who were discharged after 1, 2, 3, or 4 or more days.

Statistical Methods
The ² test with appropriate degrees of freedom was used to evaluate differences between groups 1 and 2 for the following variables: distribution of patients in the nine risk categories; percentages of patients with each preoperative risk factor; changes in the distribution of length of ICU stay (1, 2, 3, and 4 or more days) by comparing the proportions of patients in each category; and risk-unadjusted mortality and morbidity rates. Where appropriate, Fisher’s exact test was used in place of the ² test. Kendall’s tau-b [7] provided a measure of association risk level and group.

Summary risk-adjusted rates were calculated using a direct adjustment method in which risk category–specific rates for each period were applied to the corresponding categories of a "standard population" created by combining all the patients in both groups [8]. An adjusted rate was obtained by dividing the resulting total number of patients with the outcome of interest by the 7,844 patients in the standard population. An indirect adjustment method was used in the case of renal failure because the risk category–specific rate in group 2 was zero. Risk category–specific rates for renal failure in group 1 were applied to group 2 to yield a number of "expected" cases of renal failure, and then were compared with the observed number of cases of renal failure in group 2.

Analyses of mortality rates, morbidity rates, and ICU length of stay between groups 1 and 2, adjusting for risk level, were performed by applying a logistic transformation to the risk category–specific rates and forming contrasts with their corresponding approximate variances [8]. The transformed data were distributed approximately normally, allowing the use of parametric tests. The Z test then was applied to determine the statistical significance of any differences between groups. The ² and Fisher’s exact tests were performed with SAS Release 6.04 software, and the Z test was performed with Microsoft’s Excel statistical functions program. All tests were two-tailed, with set at 0.05.

	Results

Top Abstract Introduction Material and Methods Results Comment References

 
Differences in Risk Scores
The distributions of risk scores differed significantly, with patients in group 2 being at significantly increased risk (p < 0.001 by ² analysis; Kendall’s tau = 0.102; 95% confidence interval = 0.082 to 0.122, indicating essentially no correlation between the distributions) (Fig 1). Group 2 had significantly higher percentages of patients in 8 of the 13 risk factor categories, including higher percentages of patients with severe left ventricular dysfunction and emergency operations (Table 1). Only the percentage of patients with prior vascular operations was significantly lower in group 2. The percentages of patients with a weight of less than 65 kg, cerebrovascular disease, anemia, or chronic obstructive pulmonary disease did not differ significantly between the two groups (see Table 1).

View larger version (15K): [in this window] [in a new window]   Distribution of preoperative risk scores for patients who underwent coronary artery bypass grafting between 1986 and 1988 (group 1) and between 1993 and 1994 (group 2).

There was no significant difference in the mortality rate between the two groups for any risk category except for 7 to 9 (Fig 2). For the patients who died in the hospital, the statistically significant differences between group 1 and group 2 are shown in Table 2.

View larger version (13K): [in this window] [in a new window]   Mortality rates, with 95% confidence intervals at various preoperative risk levels, of patients who underwent coronary artery bypass grafting.

Differences in the Intensive Care Unit Length of Stay
Both before and after adjusting for risk, a significantly higher percentage of patients in group 2 were discharged from the ICU on the first postoperative day (risk-adjusted rate, 52% to 45%; p < 0.001). In addition, a significantly smaller percentage of patients in group 2 remained in the ICU for more than 3 days (16% versus 18%, respectively; p = 0.025) (Table 4).

	Comment

Top Abstract Introduction Material and Methods Results Comment References

Greater use of arterial conduits [9]

Refined reoperative techniques [5] [10]

Expedited triage of emergencies [4]

Cold blood cardioplegia [11]

Retrograde-antegrade cardioplegia [12] [13]

Single aortic cross-clamping [14]

Membrane oxygenators and arterial filters [15]

Extensive perioperative hemodynamic monitoring [4]

Early detection and prompt management of isch emia [4]

Early use of assist devices

Potent opioid anesthetics [16]

Muscle relaxants free of cardiovascular effects [17]

Better understanding of hemodilution [18]

Appropriate hematocrit levels for optimal hemody namics [18]

Decreased intensive care unit length of stay [19]

Support of renal function (use of dopamine) [6]

Postoperative hemodynamic management and timely analgesia [20] [21]

Neurologic protection [9] [14] [15]

Changes in the Patient Population
The percentage of patients at the lower end of the risk scale (risk scores of 3 or less) decreased from 68% to 57%, whereas the percentage of patients at high risk (risk scores of 4 or more) increased from 32% to 43%. We believe this change is a result of marked increases in the number of reoperations, emergency operations, and older patients undergoing operation; the incidence of severe left ventricular dysfunction; and the presence of concomitant disease, such as diabetes and renal dysfunction (see Table 1). For example, the rate of reoperation increased from 18% to 23%, which reflects changes in the referral pattern to our institution for these procedures [5] [10].

The volume of emergency procedures also increased in group 2 (from 3% to 4%; p = 0.02), largely because of an increased number of angiographic interventions and related complications, as well as an increase in the number of referred patients who required emergency surgical intervention. The indication for emergency operation in group 1 often was severe left main trunk lesions [22] or uncontrolled angina. These cases posed a lesser risk than did emergency cases that resulted from complications of percutaneous transluminal coronary angioplasty, which constituted the largest subgroup of emergency cases in group 2. Patients with complications of angiographic interventions frequently presented for operation with severe ischemia and, occasionally, cardiogenic shock [23] [24].

The increased age of the patients in group 2 [25] probably reflects the use of aggressive medical treatment with ß-blockers, calcium-channel blockers, long-acting nitrites, and angiotensin-converting enzyme inhibitors between 1993 and 1994, all of which delay the need for operation. In addition, during that period, a large number of patients with single- or double-vessel disease underwent percutaneous transluminal coronary angioplasty more than once, again delaying surgical intervention [26]. The aging surgical population also resulted in a significantly larger number of patients in group 2 who had concomitant conditions, including renal dysfunction and diabetes [27].

Changes in the Morbidity Rate
The mortality rate always will be perceived as the ultimate quality indicator. However, the hospital mortality rate usually includes only a small percentage of patients, and it does not reflect other important quality indicators, such as the length of the ICU and hospital stays, cost, return to work, and quality of life. In this study, we found a significant decrease in the overall and specific morbidity rates. The incidence of perioperative myocardial infarction decreased significantly in group 2, probably reflecting an improved understanding of the risk factors and pathophysiology of perioperative myocardial infarction [28]. Patients in group 2 benefited from refinements in myocardial protection strategies that were unavailable to group 1. These included the use of cold blood cardioplegia followed by a terminal, warm blood reperfusate containing amino acids, glutamate, and aspartate [20]; antegrade and retrograde delivery of the cardioplegia solution [11] [12]; and the use of a single period of cross-clamping for the entire operation [5] [13] [14] [29].

In the last decade, we became more aggressive about achieving complete revascularization and using every possible arterial conduit, mainly both internal thoracic arteries whenever feasible, which is associated with overall better outcomes [14]. The use of intraaortic balloon pumps and right ventricular and left ventricular assist devices almost doubled in group 2. Because of increased experience with these devices, they now are used earlier to stabilize hemodynamics and protect the myocardium rather than as a last resort, which helped to decrease the incidence of perioperative myocardial infarction and other complications in group 2. In 1988, we revised our triage protocols for emergencies in the cardiac catheterization laboratory to ensure early resuscitation, transfer to the operating room, and initiation of cardiopulmonary bypass and revascularization to minimize the duration of myocardial ischemia [4].

Loop and colleagues [5] [10] described in detail their improved surgical techniques in reoperations to maximize myocardial protection and hemodynamic stability and to minimize blood loss and transfusions [5] [10]. In fact, the incidence of perioperative myocardial infarction in reoperations in the current study decreased from 8.5% to 4.8% (see Table 5).

Current anesthesia management is designed to minimize hemodynamic instability and to prevent and promptly manage ischemic events during the induction of anesthesia and before the institution of cardiopulmonary bypass [4]. Patients continue ß-blocker, calcium-channel blocker, antihypertensive, and nitrate therapy to the day of operation. Large doses of potent opiates and muscle relaxants free of cardiovascular effects are administered to provide hemodynamic stability and to minimize tachycardia [9] [16]. Aggressive management of hemodynamics and ischemia, and appropriate sedation [28], are extended to the postoperative period. Every effort is made to prevent and treat early postoperative hypertension, which has been reported in 30% to 50% of patients [17].

Between 1986 and 1994, the use of blood conservation was refined, which decreased the need for blood transfusion and minimized its complications. However, we also realized the limitations of extreme hemodilution. Currently, in patients with impaired left ventricular function, target hematocrit levels are about 28% to 30%, which allows better perfusion pressure and hemodynamic stability [21].

Neurologic complications were decreased significantly before and after risk adjustment (after risk adjustment, 4.4% to 2.2%) (see Table 3). We now use a single cross-clamp to minimize the release of particulate emboli from the atherosclerotic aorta on release of the clamp [29], and we use extreme precautions to prevent embolization during reoperation [10].

Our early study of Group 1 [6] alerted us to the significance of elevated serum creatinine levels as a risk factor for postoperative renal dysfunction. In group 2, a renal dose of dopamine (4 to 6 µg · kg^-1 · h^-1) was administered routinely to patients with serum creatinine levels of greater than 1.6 mmol/L. Diuretics were administered until all free hemoglobin was excreted in the urine.

Changes in the Mortality Rate
There was a slight increase in the hospital mortality rate before risk adjustment (2.5% to 3.44%; p = 0.013) in group 2; however, this difference was no longer statistically significant when the mortality rate was adjusted for risk (2.79% to 2.94%; p = 0.15). The increase in the mortality rate before risk adjustment probably reflects the increased number of patients at high risk. The preoperative risk factors of patients who died during their hospital stay did not differ significantly between the two groups, except that the number of patients who had accompanying mitral valve insufficiency was higher in group 2.

The unchanged mortality rates in group 2, in view of the decreased overall morbidity rate and the decreased rates of perioperative myocardial infarction and neurologic complications, stimulated more detailed analysis of the patients who died in the two groups. There was no difference in the mortality rates among the different risk categories, except for category 7 to 9 (see Fig 2). Mortality rates in patients who underwent reoperations or emergency operations, and in those who were 75 years of age or older, were similar (see Table 5). There were no significant differences in the risk-adjusted rates of intraoperative or postoperative mortality.

This analysis of the differences and similarities between the two groups provided no explanation for the paradox of decreased morbidity and unchanged mortality in group 2. Perhaps there was and always will be mortality, even at low risk.

Changes in the Intensive Care Unit Length of Stay
After adjusting for risk, a significantly higher percentage of patients in group 2 (52%) than in group 1 (45%) were discharged from the ICU within 24 hours (see Table 4). This decrease probably was a result of newer protocols to provide earlier emergence from anesthesia, pain control, and optimal hemodynamic management [18].

Limitations of the Study
This study was descriptive and the analysis was retrospective. Differences in the timing of data collection may have introduced some bias into the results. We also sought to identify broad trends among our patient population and to describe the collective impact of recent changes in our procedures, rather than to investigate specific cause-and-effect relation. Thus, the results are subject to some confounding influences. In addition, these results reflect an unusually large cardiac surgical practice in a single tertiary care institution and therefore may not be applicable to other practices.

Conclusions
The results of this study lead us to conclude the following:

Patients at our institution who were operated on for coronary artery disease between 1993 and 1994 (group 2) were at higher risk than patients who were operated on between 1986 and 1988 (group 1).

In spite of the overall higher risk, patients in group 2 had a significantly lower incidence of morbidity and a shorter ICU length of stay.

The mortality rate for these patients has remained the same, despite the higher risk and reduced morbidity rates. We have no explanation for this finding. We attribute the decreased morbidity, in spite of the increased risk, to the continuous improvements in surgical, anesthetic, and postoperative management. An added decade of experience for the surgical team probably also contributed to the improved results.

	References

Top Abstract Introduction Material and Methods Results Comment References

 

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