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Ann Thorac Surg 2000;69:1792-1798
© 2000 The Society of Thoracic Surgeons

Original articles: Cardiovascular

Coronary and carotid operations under prospective standardized conditions: incidence and outcome

Thomas V. Bilfinger, MD, ScDa, Hassan Reda, MDa, Fabio Giron, MD, PhDb, Frank C. Seifert, MDa, John J. Ricotta, MDb

a Division of Cardiothoracic Surgery, Department of Surgery, University Hospital and Medical Center, State University of New York at Stony Brook, Stony Brook, New York, USA
b Division of Vascular Surgery, Department of Surgery, University Hospital and Medical Center, State University of New York at Stony Brook, Stony Brook, New York, USA

Address reprint requests to Dr Bilfinger, Div of Cardiothoracic Surgery, Dept of Surgery, State University of New York at Stony Brook Health Sciences Center, T19-080, Stony Brook, NY 11794-8191
e-mail: bilfinge{at}surg.som.sunysb.edu


   Abstract
Top
 Abstract
Introduction
 Patients and methods
 Results
 Comment
 References
 
Background. No randomized trial has yet evaluated the hypothetical benefit of carotid endarterectomy with coronary artery bypass grafting. This prospective review was undertaken to determine the differences between observed and predicted complication rates, as well as to define new predictors and assess costs in a standardized population.

Methods. A prospective nonrandomized study was undertaken over a 4-year period involving all coronary artery bypass graftings done at one institution. Operative procedure was standardized. All patients underwent preoperative screening for carotid disease. If 80% or more stenosis was present, combined coronary artery bypass grafting and carotid endarterectomy was performed.

Results. Of 2,071 patients, 1,987 had coronary artery bypass grafting only. In that group there were 34 strokes (1.7%) and 41 deaths (2.0%). Eighty-four patients underwent combined coronary artery bypass grafting/carotid endarterectomy and in that group there were four strokes (4.7%) and five deaths (5.9%). Independent risk factors for postoperative stroke were age (odds ratio 1.09; 95% confidence interval 1.04, 1.3), hypertension (odds ratio 2.67; 95% confidence interval 1.22, 5.23), extensively calcified aorta (odds ratio 2.82; 95% confidence interval 1.34, 5.97), and bypass time (odds ratio 1.01; 95% confidence interval 1.00, 1.02). Cost of a stroke was significant (p < 0.05) in both groups.

Conclusions. Patients with carotid disease fall into a higher risk group than patients without it. This increased risk is not because of carotid disease alone. Patients without significant carotid disease, who suffered a perioperative stroke, fell into an even higher risk category. Furthermore, carotid endarterectomy was not a significant risk factor by either the univariate or the multivariate analysis.


   Introduction
Top
 Abstract
 Introduction
Patients and methods
 Results
 Comment
 References
 
Controversy continues to surround the management of carotid bifurcation stenosis in patients who are in need of coronary artery bypass grafting (CABG) [1]. In recent years, issues related to the current trend toward cost consciousness and efficiency have heightened the debate over optimum strategies. Several states in the United States, as well as The Society of Thoracic Surgeons, have gathered large data sets that can serve as a baseline to assess the extent of the problem.

In 1994, the most recent year for which a complete data set is available in New York State, of 18,051 patients who underwent isolated CABG, 1,042 (5.77%) had a previous stroke. In this group of patients a mortality of 4.41% was observed [2]. Carotid/cerebral vascular disease was found in 2,100 patients (11.63%) whose mortality rate after CABG was 4.86%. New neurologic deficits reported during the hospitalization for CABG were 293 (1.62%), with a resulting mortality rate of 26.62%. This number of deficits has subsequently proved to be significantly underreported [3]. The statewide mortality in 1994 for straight first-time CABG was 2.4% and for redo operation 4.7% [2]. On many occasions investigators have called for a randomized prospective trial in patients undergoing CABG to answer the question of whether stroke is more common in patients with carotid bifurcation disease and what influence, if any, carotid endarterectomy can render [1, 4–6].

Because of concerns regarding the often debilitating nature of a stroke in this patient population, we conducted a prospective, nonrandomized study starting July 1, 1993, and ending June 30, 1997. The questions asked were: (1) What is the incidence of significant (>= 80%) carotid artery stenosis in a population with coronary artery disease requiring operative revascularization? (2) What is the outcome in this patient population as a whole and, specifically, in patients with preoperatively detected carotid artery stenosis with regard to cardiac and neurologic end points? (3) What are the costs involved in the various subgroups? This study also allowed us to determine the perioperative complication rates after CABG and combined CABG/carotid endarterectomy (CEA), as well as the difference between observed and predicted complication rates, and to define new predictors.


   Patients and methods
Top
 Abstract
 Introduction
 Patients and methods
Results
 Comment
 References
 
Preoperative assessment and conduct of operation
Between July 1, 1993, and June 30, 1997, every patient undergoing CABG at our institution was enrolled. Every patient underwent carotid duplex scanning of the carotid arteries. This evaluation constituted a departmental policy and was not subject to randomization. No patient was encountered who suffered a stroke or had a transient ischemic attack within 4 weeks before operation. For the purpose of this study, patients without symptoms for 1 month before CABG were classified as "asymptomatic." If the duplex scan suggested a carotid artery stenosis of 80% or more (n = 84), the patient underwent either carotid arteriography or magnetic resonance angiography. If the degree of stenosis of 80% or more was confirmed, the patient automatically was considered a candidate for a combined CABG/CEA operation. In cases of bilateral stenosis of 80% or more, either the worse side or the side supplying the dominant hemisphere was operated on. No patient who required CABG and who had a one-sided, completely occluded carotid and a contralateral 80% or more carotid occlusion was encountered during the time period of the study. The operative procedure was standardized in that concomitant procedures were performed in one sitting with CEA preceding the coronary revascularization.

All CEAs were performed with the use of shunts with the patient warm (37°C) and before performing the sternotomy. In addition, in all patients, an onlay patch from a segment of saphenous vein was used. This was followed in all patients by coronary revascularization, which was performed through a standard midline sternotomy using cardiopulmonary bypass. Standard aortic cannulation was used. Myocardial preservation was carried out with the application of antegrade and retrograde blood cardioplegia and, in all patients, a cross-clamp was used. The proximal anastomoses were constructed with the use of a side-biting clamp. Moderate hypothermia for the cardiac procedure of the operation was used, with the temperature ranging between 28°C and 32°C. The neck incision was left open during the cardiac procedure until after reversal of the heparin with protamine. All neck incisions were drained for 24 hours.

Stroke assessment
All patients who were candidates for combined operations had preoperative computed tomographic scans of the head, or magnetic resonance imaging scans, which were performed in conjunction with the carotid angiograms or magnetic resonance angiograms. All patients who showed neurologic symptoms postoperatively were evaluated by a neurologist and a computed tomographic scan. Based on the type of symptoms and the results of the scan, the neurologist classified the stroke according to the most probable cause as either embolic, hypoxic, or watershed.

Predictors of stroke
Significant univariate predictors of postoperative stroke were determined by a Wilcoxon rank sum test. Significant multivariate determinants of the same adverse outcome were obtained by a multivariate logistic regression analysis. Odds ratios and 95% confidence limits, as well as p values, are reported. Statistical analysis was performed using the SPSS software (SSPS, Corte Madera, CA). Significance was set at p less than 0.05. To gain insight into our mortality data, the model developed and extensively published by the New York State Department of Health was used to compare observed with predicted outcomes [7].

Statistics
Other than the methods mentioned above, Student’s t test and the {chi}2 test were used for comparison of groups. Significance was set at p less than 0.05.

Costs
For determination of cost, a case-match methodology was used. This was chosen because of the small number of patients in the combined group that had a stroke. Factors taken into account for the case-match were age, gender, body size, ejection fraction, amount of coronary disease, ischemic time, bypass time, status of the ascending aorta, extent of peripheral vascular disease, presence of diabetes, chronic obstructive pulmonary disease, and absence of postoperative complications other than the variables looked for. Hospital costs were derived from a computer database comprising costs related to the operating room personnel and equipment, intensive care unit, pharmacy, laboratory, respiratory therapy, radiology, physical therapy, vascular laboratory, electrocardiogram, and nutritional services, as well as regular floor costs. Not considered were professional fees. Each patient was matched with the best fit from the computer database, and costs incurred by selected patients were obtained in 1997 U.S. dollars. The average cost was calculated for each group.


   Results
Top
 Abstract
 Introduction
 Patients and methods
 Results
Comment
 References
 
Demographic data
During the time period of the study, 2,071 patients underwent CABG. These 2,071 patients were divided into two groups. The first group comprised the patients with no significant carotid artery disease (ie, < 80% diameter stenosis). It contained 1,987 patients who underwent CABG only (CABG-only group). The second group comprised 84 patients with significant carotid artery disease determined preoperatively; they underwent combined simultaneous CEA and CABG (combined group). Demographic and preoperative clinical findings for all patients are summarized in Tables 1 and 2. The patients in the combined group were significantly older (p = 0.001) than those in the CABG-only group. Male predominance was similar in both groups. Hypertension, history of previous myocardial infarction, peripheral vascular disease, and history of stroke, as well as renal failure, were significantly more common in the combined group. The intraoperative characteristics were comparable between the two groups (Table 3).


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  		Table 1. Demographic Data

 

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  		Table 2. Preoperative Risk Factors

 

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  		Table 3. Cardiac Operative Characteristics

 
Stroke
Thirty-eight patients had a stroke (1.8%). Four of these patients were in the combined group (4.76%), and the remaining 34 were in the CABG-only group (1.71%). Patients in the combined group who sustained a stroke were on average 5 years older than patients in the CABG-only stroke group (76 versus 71.9 years, p < 0.001). In stroke patients from both groups, a high incidence of previous myocardial infarctions (75% versus 59%, p < 0.001) was noted. A history of a previous stroke was particularly high (15.4%) in the combined group versus that in the CABG-only group (5.6%, p < 0.05). Of the CABG-only patients who had strokes, 8 patients had normal preoperative carotid evaluation, 22 patients had less than 60% stenosis, and 4 patients had 60% or greater stenosis, but less than 80%. These last 4 patients had their stroke on the side of the carotid stenosis. Ten of the 34 patients who had a stroke in the CABG-only group had a period of normal postoperative neurologic evaluation before the development of the symptoms. In 19 patients, the symptoms were first noticed on the first postoperative day. In 9 patients, symptoms were noticed during the first week after operation. The underlying cause, as determined by neurologic examination and from computed tomographic scan, was believed to be embolic in 29 patients and hypoxic (either diffuse or to watershed areas) in 5 patients (Table 4).


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  		Table 4. Stroke Patients’ Demographics and Preoperative Risk Factors

 
Duration of hospitalization
It was found that 87.6% of patients underwent CABG with preoperative cardiac catheterization during the same admission (DRG 106). Hospitalization is given as a total. Combined procedures were also performed during the same hospitalization, leading to an increased length of stay of 1 day, which was lost preoperatively because of having to obtain an additional diagnostic study (magnetic resonance angiography/carotid angiography). Noteworthy is the 2.67-fold increase in hospital stay in the CABG group that sustained a stroke (p < 0.001). This increased length of stay translated directly into dollars. The costs, as determined by the case-match study in 1997 U.S. dollars were highest for the CABG with stroke patients (Tables 5 and 6).


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  		Table 5. Duration of Hospitalization in Days

 

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  		Table 6. Costs of Hospital Stay

 
Predictors of stroke and mortality
In a univariate analysis of independent risk factors for postoperative stroke, seven variables were found to be significant (age, bypass time, aortoiliac disease, chronic obstructive pulmonary disease, extensively calcified aorta, hypertension, carotid disease). In the subsequent multivariate analysis, only age, extensively calcified aorta, hypertension, and, as the weakest variable, bypass time were found to be significant (Table 7). Although prolonged bypass time was statistically significant (p < 0.001), the odds ratio is barely different from 1.0, indicating minor effect. Carotid endarterectomy was included in the logistic model to establish whether other variables are independent predictors of stroke after adjusting for carotid endarterectomy.


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  		Table 7. Independent Predictors of Postoperative Stroke

 
We were able to compare our data to the multivariate regression model developed by the New York State Department of Health, which has been refined over time. Using that model, the predicted mortality for CABG and CABG/CEA combined closely matched our observed results (1.81% versus 2.06%). The additive effect of a stroke on mortality in the CABG alone group was striking (8.4% versus 26.4%). The number of combined patients who suffered a stroke was too small to analyze (Table 8).


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  		Table 8. Predicted Versus Observed Mortality

 
The cause of death in the CABG-only group was cardiac in 17 patients (myocardial infarction, low output syndrome, intractable arrhythmia), and noncardiac (ie, stroke and complications) in 6 patients. Renal failure, gastrointestinal complications, respiratory failure, and multisystem organ failure accounted for an additional 18 deaths.

In the combined group, there were five deaths: two patients died of respiratory failure, one died of pulmonary embolism, one died of ischemic bowel, and one died of myocardial infarction. No patient died as a direct result of their stroke.

The most striking finding in the present study is the significantly increased mortality in the CABG-only stroke group. The predicted and observed mortality was even higher than that of the combined group. Operative conduct was controlled, and for both study groups, use of intraaortic balloon pumping and ejection fraction were not different. Statistically significant differences were found for age, hypertension, previous myocardial infarction, aortoiliac disease, and extensively calcified aorta, suggesting that these patients demonstrate more advanced arteriosclerosis. Patients with or without stroke who required combined operations resemble very much those patients with stroke in the CABG-only stroke group (Tables 4 and 9).


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  		Table 9. Risk Factors of CABG With Stroke Versus No Stroke

 

   Comment
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
References
 
Although there is no argument that patients with hemispheric symptoms localized to the site of a significant carotid stenosis are at high risk of incurring a stroke during or after CABG, the data are much less clear with regard to asymptomatic patients. The current debate centers mainly around the question of whether the carotid stenosis per se is an etiologic factor, or whether it simply expresses a higher risk because of factors such as atherosclerotic disease of the aorta or generalized atherosclerosis. There are proponents of both positions. For instance, the asymptomatic carotid atherosclerosis study showed that CEA, under carefully controlled conditions, can reduce the risk of stroke in patients with asymptomatic stenosis of more than 60% [8]. On the other hand, one of the more recent studies reports a 2.9% perioperative stroke rate in 137 patients with unilateral carotid stenosis who underwent CABG alone, suggesting that patients with carotid stenosis are not at significant increased stroke risk after CABG alone [9].

In nine reports published between 1990 and 1997, the prevalence of carotid obstruction in excess of 70% reached from 5.6% to 12% [4]. In this patient population, the predictors of significant carotid stenosis by multivariate analysis were found to be in decreasing order: age, diabetes, female sex, left main coronary artery stenosis of more than 60%, prior stroke or transient ischemic attack, peripheral vascular disease, prior vascular operation, and, least important, smoking. Given that we chose 80% as the cutoff for significant stenosis, the incidence of 4.06% falls right within these published numbers [4].

Options in the management of patients with concomitant surgical disease in both carotid and coronary circulations include performing only CABG, staging CEA and CABG with CEA performed either before CABG or within 10 days of CABG (ie, reverse staging) and synchronously performing CEA and CABG. The current controversy, which will not be resolved until a prospective randomized study is done, centers mainly around the question of whether CEA should be done before CABG. Carotid endartectomy before CABG increases perioperative mortality; CEA preceded by CABG carries an increased stroke risk. This is not only supported by the data from the Cleveland Clinic, but also by the findings of the ad-hoc committee of the American Heart Association, which performed a metaanalysis of data culled from 56 English-language reports [10, 11]. This controversy may have gained new momentum with the advent of off-pump CABG. Difficulty in comparing the two approaches to performing CEA and CABG (staged versus synchronous) stems also from institutional policies. For instance, the Buffalo group used both approaches and reported a selection bias, whereby the overall sicker patient wound up in the synchronous group [5]. The lowest stroke rate with a staged approach (1.9%) has been reported by the Texas Heart Institute [12]. The purported benefits of the synchronous approach include decreased exposure to anesthesia with a reduction in perioperative myocardial infarctions. In the era of increased cost awareness, new arguments of decreased hospital stay and significant cost savings are being considered. A comparison of recent published results is provided on Figure 1.



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  		Fig 1. Comparative figures of recent reports of combined coronary artery bypass grafting and carotid endarterectomy.

 
A further comparison of results is often hampered by the variable definition of stroke itself. In a careful study performed with pre- and postoperative neurologic assessment by neurologists versus surgeons, Engelman and colleagues [3] found an incidence of neurologic deficits of about 5%, less than half of which were clinically significant. This supports the suspicion that the incidence of stroke in many databases, such as the New York State Database or that of The Society of Thoracic Surgeons, is underreported. Because the cause is multifactorial, it is also worth noting that there are very few data available concerning the specific conduct of an operation and its effect on stroke rate, be it synchronous or not. Takach and colleagues [12] performed a multivariate logistic regression analysis and found no correlation with shunt versus no shunt, or with onlay patch versus direct closure of the carotid artery. The present study describes a patient population for which these technical operative details were known and controlled for in the statistical analysis.

On the basis of New York State data, a predictive risk model for stroke has been constructed, which now awaits validation [6]. The predictive risk factors for a stroke detected by our multiple logistic regression analysis have all been reported previously. Carotid endarterectomy as an adjunct to CABG has not increased the risk of mortality. Whether CEA prevents perioperative strokes awaits a prospective trial. Nevertheless, there is mounting evidence that it does prevent long-term strokes [8].

Strokes are costly, especially in the CABG-only group. However, according to the methodology published recently by Lee and colleagues [13], the group of patients with asymptomatic carotid lesions fulfills the criteria for cost-effectiveness only if a combined procedure is performed. The following costs in 1997 U.S. dollars were incurred: CABG (DRG 106), $19,263; CABG and CEA, $29,288; CABG with stroke, $49,479; CABG/CEA and stroke, $38,130. Comparing synchronous CEA/CABG to isolate CEA and isolated CABG, Daily and associates [14] found a reduction in reimbursement for the hospital component of $87,575 (27%, 1995 U.S. dollars); in addition to an 18.21% savings in the surgical fee and a 17.6% savings in the anesthetic fee, for a total of $10,077 (25.3%).

Given these cost figures and given our finding that four strokes in the CABG-only group (localized to the side of the obstruction), occurred in patients with 60% to 80% stenosis, carotid duplex screening in high-risk patients appears to be justified. High risk from these data includes previous stroke, longstanding hypertension, severe vascular disease, and age of 70 years or older. Nevertheless, the perioperative strokes observed in the present study are not explained by the degree of carotid stenosis. Moreover, CEA was found not to be a statistically significant variable in this patient population.


   References
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 

  1. Bilfinger T., Petersen M., Ricotta J.J. Coronary artery bypass grafting with carotid endarterectomy. In: Yao J.S., Pearce W.H., eds. Practical vascular surgery. Stamford, CT: Appleton & Lange, 1999:147-160.
  2. New York State Department of Health. Coronary artery bypass surgery in New York State 1994–1996. Albany: New York State Department of Health, 1998.
  3. Engelman R.M., Pleet A.B., Rousou J.A., et al. Influence of cardiopulmonary bypass perfusion temperature on neurologic and hematologic function after coronary artery bypass grafting. Ann Thorac Surg 1999;67:1547-1556.[Abstract/Free Full Text]
  4. Faggioli G.L., Curl G.R., Ricotta J.J. The role of carotid screening before coronary artery bypass. J Vasc Surg 1990;12:724-731.[Medline]
  5. Ricotta J.J. Carotid endarterectomy and coronary bypass. In: Yao J.S., Pearce W.H., eds. Progress in vascular surgery. Stamford, CT: Appleton & Lange, 1997:653-655.
  6. John R., Choudhri A.F., Weinberg A.D., et al. Multicenter review of preoperative risk factors for stroke after CABG. Ann Thorac Surg 2000:30-36.
  7. Hannan E.L., Kilburn H., Jr, O’Donnell J.F., et al. Adult open heart surgery in New York State. JAMA 1990;264:2768-2774.[Abstract/Free Full Text]
  8. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. Endarterectomy for asymptomatic carotid artery stenosis. JAMA 1995;273:1421-1428.[Abstract/Free Full Text]
  9. D’Agostino R.S., Svensson L.J., Neumann D.J., et al. Screening carotid ultrasonography and risk factors for stroke in coronary artery surgery patients. Ann Thorac Surg 1996;62:1714-1723.[Abstract/Free Full Text]
  10. Moore W.S., Barnett H.J., Beebe J.H., et al. Guidelines for carotid endarterectomy. A multidisciplinary consensus statement from the ad hoc committee, American Heart Association. Stroke 1995;26:188-201.[Abstract/Free Full Text]
  11. Hertzer N.R., Loop F.D., Beven E.G., et al. Surgical staging for simultaneous coronary and carotid disease. J Vasc Surg 1989;9:455-463.[Medline]
  12. Takach T.J., Reul G.J., Jr, Cooley D.A., et al. Is an integrated approach warranted for concomitant carotid and coronary artery disease?. Ann Thorac Surg 1997;64:16-22.[Abstract/Free Full Text]
  13. Lee P.T., Solomon N.A., Heidenreich P.A., et al. Cost-effectiveness of screening for carotid stenosis in asymptomatic persons. Ann Intern Med 1997;126:337-346.[Abstract/Free Full Text]
  14. Daily P.O., Freeman R.K., Dembitsky W.P., et al. Cost reduction by combined endarterectomy and coronary artery bypass grafting. Ann Thorac Surg 1997;63:516-521.[Abstract/Free Full Text]
Accepted for publication December 22, 1999.


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