From the Center for Clinical Health Policy Research (L.B.G., G.P.S.,
D.B.M., E.Z.O.), the Duke Center for Cerebrovascular Disease (L.B.G.), and the
Divisions of Neurology (L.B.G.) and General Internal Medicine (D.B.M.,
E.Z.O.), Department of Medicine, Duke University, and the Center for Health
Services Research in Primary Care (D.B.M., E.Z.O.) and Division of Neurology
(L.B.G.), Durham Department of Veterans Affairs Medical Center, Durham, NC.
Correspondence to Larry B. Goldstein, MD, Box 3651, Duke University Medical Center, Durham, NC 27710. E-mail golds004{at}mc.duke.edu
Methods—Data regarding postoperative complications were
systematically abstracted from the medical records of a random
sample of patients who underwent carotid
endarterectomy at 12 academic medical centers.
Results—Of 1160 procedures reviewed, 463 (40%) were performed
for asymptomatic disease. Postoperative stroke or death
occurred in 13 (2.8%), and myocardial infarction occurred in 8
(1.7%). The rate of postoperative stroke or death was lower in
asymptomatic patients than in those with a history of
cerebrovascular symptoms in a different vascular distribution, but the
difference was not significant (1.8% versus 4.2%;
P=.21). There were no significant differences in these
rates based on race, a history of angina, recent myocardial infarction,
chronic obstructive pulmonary disease, hypertension, the degree
of stenosis of the contralateral or ipsilateral carotid artery,
or the presence of angiographically recognized ulceration, intraluminal
thrombus, or siphon stenosis in the ipsilateral vessel
(
Conclusions—The overall risk of postoperative stroke or death was
nearly twice that reported by Asymptomatic Carotid
Atherosclerosis Study (ACAS) investigators in the
setting of a clinical trial but was within acceptable guidelines. Women
were at higher postoperative risk than men, which supported ACAS
findings. Additional high-risk groups were those aged 75 years or
older, those with a history of congestive heart failure, and those
undergoing prophylactic endarterectomy
for asymptomatic stenosis in combination with
coronary surgery. Knowledge of these rates may help to better
assess an individual's postoperative risk and therefore the
anticipated benefit of surgery.
Little data are available concerning the impact of specific patient
characteristics on the risk of carotid
endarterectomy in asymptomatic patients
outside the setting of randomized controlled trials. We previously
performed a review of carotid endarterectomies performed at 12 academic
medical centers and developed an overall risk model based on
preoperative factors.9 A second analysis
focused on patients undergoing carotid
endarterectomy for symptomatic
disease.10 The goal of the present study was
to identify preoperative clinical factors associated with an increase
in the risk of carotid endarterectomy in patients
who underwent the operation for asymptomatic
stenosis.
Hospital charts for the admission during which carotid
endarterectomy was performed were systematically
reviewed by abstractors using a defined protocol. Data included patient
demographics, comorbid diseases, neurological symptoms (type, location,
and frequency of symptoms), data from the radiologists' reading of
preoperative carotid angiograms, clinical details from the operative
report, and postoperative complications. When sufficient data were
available, the patient's preoperative functional abilities were rated
(impaired or unimpaired in activities of daily living). Angiographic
risk factors were considered "absent" unless specifically
recorded in the radiologist's report. Recorded operative
factors included the use of a shunt, the use of a patch graft, and
whether prophylactic carotid
endarterectomy was performed as a combined
procedure with coronary artery bypass graft (CABG) surgery.
Abstracted data forms (along with xerographic copies of discharge
summaries, angiogram, and operative reports) were reviewed by a study
investigator. Adverse outcomes included postoperative in-hospital
strokes, myocardial infarctions, and deaths occurring during the
hospitalization for carotid endarterectomy.
Univariate Fisher's exact tests were used to identify
potentially important predictors, and
Forty percent of the 1160 patients undergoing carotid
endarterectomy were asymptomatic or had
symptoms in a vascular territory other than that of the operated artery
(n=463). We previously found that the rate of postoperative
complications (either stroke, myocardial infarction, or death) was
lower in patients undergoing endarterectomy for
asymptomatic stenosis than in those undergoing the
operation for symptomatic disease (4.8% versus 8.5%;
P<.01).10 This difference was largely
related to a lower risk of postoperative stroke in the patients
undergoing the operation for asymptomatic carotid artery
stenosis (2.2% versus 5.7%; P<.004). The rates of
postoperative myocardial infarction (2.4% versus 3.2%;
P=.40) and death (1.1% versus 1.6%; P=.50) were
also lower in these patients, but the differences were not significant
compared with patients with ipsilateral symptoms. The combined risk of
postoperative stroke or death in patients undergoing carotid
endarterectomy for asymptomatic disease
was 2.8% compared with 6.2% for patients undergoing the operation for
symptomatic disease (P=.01). A total of 189 of
the 463 patients (41%) who had endarterectomies performed for
asymptomatic stenosis had cerebrovascular symptoms
in other vascular distributions. Although these patients were at higher
risk of complications than asymptomatic patients (4.2%
versus 1.8%), the difference was not significant (P=.21).
These subgroups were combined for further analyses.
The Table
Female sex, age 75 years or older, and a history of congestive heart
failure were each associated with a higher risk of postoperative stroke
or death. These factors were identified based on univariate
tests of significance, and there may be significant intercorrelations
among the selected variables. Because of the small number of
outcome events, the data were not amenable to formal regression
modeling, and we cannot comment on the independent contributions of the
individual variables. In addition, the power to detect a difference
in some variables may be limited.
The validity of factors identified through analyses performed
in a given study such as ours can be supported if similar results are
found in an independent data set. Although approximately one third of
the centers participated in ACAS, the number of ACAS patients in the
present sample was negligible. The ACAS investigators found a lower
point estimate for the efficacy of carotid
endarterectomy in women, which was attributed to a
higher, albeit nonsignificant, sex-based complication rate (3.6% in
women versus 1.7% in men; P=.08).6
Although the potential reasons for this increased
perioperative risk in women remain speculative, similar
results in these two very different types of studies suggest that the
finding is not spurious. Age 75 years or older and a history of
congestive heart failure were also associated with an increased risk of
postoperative complications in the present analysis. In
ACAS, those older than 75 years had a 3.8% incidence of postoperative
stroke or death compared with 2.2% of those younger than 75 years
(P=.25).7 Those with a history of
congestive heart failure had a 5.6% postoperative risk versus a 2.3%
risk in patients without such a history
(P=.39).7 Therefore, as with sex,
these variables were also associated with a somewhat higher (but
not statistically significant) perioperative risk.
However, the magnitude of these differences was greater in the
present analysis based on patients having the operation
outside the setting of a randomized trial.
Analysis of ACAS data revealed that a prior history of stroke,
contralateral stenosis greater than 60%, contralateral siphon
stenosis, and never consuming alcoholic beverages were
associated with a higher risk of perioperative
events.7 Those with a history of transient
ischemic attack or stroke in a vascular distribution other than
that of the operated artery were also at somewhat higher risk in the
present study (4.2% versus 1.8%), but the difference was not
significant. There was also a trend toward higher complication rates in
patients with higher degrees of contralateral stenosis (3.6%
to 4.0% versus 1.4% to 1.6%; Table
The few patients undergoing prophylactic
endarterectomy for asymptomatic
stenosis in combination with CABG surgery were at particularly
high risk for postoperative complications. Because there were no
comparison control data, it is not possible to determine how a similar
group of patients having only CABG would have fared. The approach to
these types of patients remains
controversial16 17 ; however, given the apparent
perioperative risk of complications in those having
combined procedures compared with the perioperative
incidence of stroke in patients undergoing CABG alone, extreme caution
should be exercised.18 19
Several important caveats should again be stressed. First, this was a
retrospective survey with all of its inherent limitations. Unless a
factor was noted in the medical record, it was considered to be
absent. This is particularly important with respect to the angiographic
data and for the identification of mild, nondisabling strokes. Second,
because there were relatively few postoperative complications, the use
of multivariate analysis was precluded. Such
analyses would require much larger data sets than are currently
available. Finally, the present analyses were performed on
the basis of data collected several years ago. As noted, the overall
safety of carotid endarterectomy has likely
improved. However, there is no reason to believe there should be a
change in the relative impact of individual risk factors.
A European study on the efficacy of carotid
endarterectomy continues to enroll patients. A
careful analysis of preoperative risk factors from this study
compared with those identified through ACAS and through studies such as
ours will provide further data to aid the risk stratification of
potential candidates for this prophylactic procedure.
Received November 20, 1997;
revision received January 26, 1998;
accepted January 26, 1998.
2.
Committee on Health Care Issues. Does carotid
endarterectomy decrease stroke and death in
patients with transient ischemic attacks? Ann
Neurol. 1987;22:72–76.[Medline]
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Matchar DB, Pauker SG.
Endarterectomy in carotid artery disease: a
decision analysis. JAMA. 1987;258:793–798.
4.
Easton JD, Wilterdink JL. Carotid
endarterectomy: trials and tribulations. Ann
Neurol. 1994;35:5–17.[Medline]
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5.
Barnett HJM, Warlow CP. Carotid
endarterectomy and the measurement of
stenosis. Stroke. 1993;24:1281–1284.
6.
Executive Committee for the Asymptomatic
Carotid Atherosclerosis Study.
Endarterectomy for asymptomatic carotid
artery stenosis. JAMA. 1995;273:1421–1428.
7.
Young B, Moore WS, Robertson JT, Toole JF, Ernst CB,
Cohen SN, Broderick JP, Dempsey RJ, Hosking JD. An analysis of
perioperative surgical mortality and morbidity in the
asymptomatic carotid atherosclerosis study.
Stroke. 1996;27:2216–2224.
8.
Moore WS, Young B, Baker WH, Robertson JT, Toole JF,
Vescera CL, for the ACAS Investigators. Surgical results: a
justification of the surgeon selection process for the ACAS trial.
J Vasc Surg. 1996;23:323–328.[Medline]
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McCrory DC, Goldstein LB, Samsa GP, Oddone EZ,
Landsman PB, Moore WS, Matchar DB. Predicting complications of carotid
endarterectomy. Stroke. 1993;24:1285–1291.
10.
Goldstein LB, McCrory DC, Landsman PB, Samsa GP,
Ancukiewicz M, Oddone EZ, Matchar DB. Multicenter review of
preoperative risk factors for carotid
endarterectomy in patients with ipsilateral
symptoms. Stroke. 1994;25:1116–1121.[Abstract]
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Harrell FE Jr, Lee KL, Matchar DB, Reichert TA.
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BJ, Brott T, Caplan LR, Day A, Goldstone J, Hobson RW II, Kempczinski
RF, Matchar DB, Mayberg MR, Nicolaides AN, Norris JW, Ricotta
JJ, Robertson JT, Rutherford RB, Thomas D, Toole JF, Trout HH
III, Wiebers DO. Guidelines for carotid
endarterectomy: a multidisciplinary consensus
statement from the Ad Hoc Committee, American Heart Association.
Stroke. 1995;26:188–201.
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Rothwell PM, Slattery J, Warlow CP. Systematic
comparison of the risks of stroke and death due to carotid
endarterectomy for symptomatic and
asymptomatic stenosis. Stroke. 1996;27:266–269.
14.
Fode NC, Sundt TM Jr, Robertson JT, Peerless SJ,
Shields CB. Multicenter retrospective review of results and
complications of carotid endarterectomy in 1981.
Stroke. 1986;17:370–376.
15.
Dyken ML. Controversies in stroke: past and
present: the Willis Lecture. Stroke. 1993;24:1251–1258.
16.
Chang BB, Darling RC, Shah DM, Paty PS, Leather
RP. Carotid endarterectomy can be safely performed
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coronary artery bypass grafts. Am J Surg. 1994;168:94–96.[Medline]
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Bass A, Krupski WC, Dilley RB, Bernstein EF. Combined
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© 1998 American Heart Association, Inc.
Original Contributions
Multicenter Review of Preoperative Risk Factors for Endarterectomy for Asymptomatic Carotid Artery Stenosis
Abstract
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
Appendix 1
References
Background and Purpose—The benefit
of carotid endarterectomy is highly dependent on
surgical risk. However, little data are available concerning factors
affecting the risk of endarterectomy performed for
asymptomatic carotid artery stenosis outside the
setting of a randomized controlled trial. The purpose of this study was
to analyze the impact of potential preoperative risk factors on
the frequency of postoperative complications in patients undergoing the
operation for asymptomatic disease in academic medical
centers. 
2; P>.05). Postoperative stroke or
death was more frequent in women (5.3% versus 1.6% in men;
P=.02), in those aged 75 years or older (7.8% versus
1.8% in those younger than 75 years; P=.01), and in
those with a history of congestive heart failure (8.6% versus 2.3% in
those without a history of congestive heart failure;
P=.03). The risk of stroke or death was higher in the 16
patients who had carotid endarterectomy performed
in combination with coronary artery bypass surgery than in
those who had only endarterectomy (18.7% versus
2.1%; P<.001).
Key Words: angiography • carotid endarterectomy • prognosis • risk factors
Introduction
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
Appendix 1
References
The benefit of
carotid endarterectomy in comparison to medical
therapy alone is highly dependent on surgical
risk.1 2 3 4 5 A critical feature of the
Asymptomatic Carotid Atherosclerosis Study
(ACAS), which demonstrated the efficacy of the operation when performed
in selected patients with asymptomatic disease, was the
very low observed rate of perioperative complications
(estimated combined morbidity and mortality rate of
2.7%).6 Central to this low complication rate
was the careful selection of surgeons with extensive experience and
demonstrated competence.7 8 In addition to the
skill of the surgeon, the risk of carotid
endarterectomy may also be related to
characteristics of the patient undergoing the operation. In ACAS, a
history of diabetes, contralateral carotid artery stenosis, and
never consuming alcoholic beverages were associated with a higher risk
of perioperative complications.7
In addition, although not statistically significant, lower estimates of
efficacy in women than in men were attributed to their higher risk of
surgical complications.6
Subjects and Methods
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
Appendix 1
References
Details of the primary data collection methodology have
been reported previously.9 Briefly, 100 carotid
endarterectomies were selected randomly from all those performed during
the calendar years 1988 to 1990 at each of 11 of the 12 member
hospitals of the Academic Medical Centers Consortium (see the
Appendix). The cases were identified from administrative records
without additional knowledge of the patients' preoperative clinical
status or subsequent course. Because of a lower operative volume, the
100 procedures were randomly selected from those performed during the
calendar years 1987 to 1990 in the 12th hospital. Forty cases were
subsequently excluded from further analysis because the
operative procedure was miscoded in administrative records.
Records from the remaining 1160 carotid endarterectomies constitute
the primary data set. 2
statistics were used for comparisons of categorical data as indicated.
Logistic regression modeling was not appropriate because the number of
outcome events was relatively small and the number of potential risk
factors was relatively large (regression analysis is unreliable
when there are fewer than 10 times as many outcome events as there are
candidate variables).11
Results
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
Appendix 1
References
An initial analysis of the data failed to reveal any
significant differences in adverse outcomes among the 12 hospitals
constituting the Academic Medical Center
Consortium.9 Therefore, hospital-level
variables were not further considered, and the data were collapsed
for further analysis. 
presents a list of
candidate variables with the frequencies of postoperative stroke
and death and associated univariate probabilities.
Significant medical and demographic variables included sex, age 75
years or older, and a history of congestive heart failure. There were
no relationships between a variety of angiographically defined
potential risk factors and postoperative complications. Stroke or death
was more common among patients in whom the surgeon used a patch graft
(3.9% versus 1.1%), but the difference was not significant
(P=.08). Patients who had prophylactic
endarterectomy in association with CABG were at
particularly high risk of postoperative stroke or death (18.7% versus
2.1%; P<.001).
View this table:
[in a new window]
Table 1. Potential Risk Factors for Postoperative Stroke or Death
Discussion
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
Appendix 1
References
The overall rate of postoperative nonfatal stroke or death (2.8%)
for patients undergoing carotid endarterectomy for
asymptomatic stenosis was within the guidelines
recommended by the American Heart Association.12
This rate of postoperative adverse events for
endarterectomy performed for
asymptomatic disease is similar to that reported in a
recent systematic literature review (3.35% rate of
perioperative stroke or death).13
However, it should be noted that because the present study was
retrospective, the traditional definition of
perioperative complications as those occurring within
30 days of the surgical procedure was not employed. Only those events
recorded during the index hospitalization were recorded.
Therefore, the 2.8% rate of postoperative stroke or death may
represent an underestimate of the true complication rate at the
time the study data were collected. This rate is nearly twice that
later obtained by ACAS surgeons (1.5% risk of stroke or death within
30 days of carotid endarterectomy)
6 but somewhat less than the 5.3% reported by
Fode et al14 based on a community survey of
complications of carotid endarterectomies performed for
asymptomatic bruit carried out more than a decade
previously. Although the difference between this latter rate and that
found in the present review is not statistically significant
(2; P=.10), the decrease is
consistent with other data suggesting that the safety of the
operation has improved over the last
decade.15 
), but again, the difference was
not significant. These potential risk factors should be further
examined in future analyses. We did not collect data concerning
the patient's history of alcohol consumption or the degree of
contralateral siphon stenosis.
Appendix 1
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
Appendix 1
References
Member institutions of the Academic Medical Center Consortium
are as follows: Alton Ochsner Medical Foundation, New Orleans, La;
Brigham and Women's Hospital, Boston, Mass; Dartmouth-Hitchcock
Medical Center, Lebanon, NH; Duke University Medical Center, Durham,
NC; Johns Hopkins Hospital, Baltimore, Md; Massachusetts General
Hospital, Boston, Mass; Mayo Clinic Foundation, Rochester, Minn; New
England Medical Center Hospitals, Boston, Mass; UCLA Medical Center,
Los Angeles, Calif; University of Iowa Hospitals and Clinics, Iowa
City, Iowa; University of Pennsylvania Medical Center, Philadelphia,
Pa; and University of Rochester Medical Center, Rochester, NY.
Acknowledgments
This study was supported by the Commonwealth Fund, the John A.
Hartford Foundation, American Medical Association, the Academic Medical
Center Consortium, the RAND Corporation, and the Agency for Health Care
Policy and Research, contract No. 282-91-0028.
References
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
Appendix 1
References
1.
Whisnant JP, Sandok BA, Sundt TM, Jr. Carotid
endarterectomy for unilateral carotid system
transient cerebral ischemia. Mayo Clin Proc. 1983;58:171–175.[Medline]
[Order article via Infotrieve]
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N. Hernandez, S. X. Salles-Cunha, Y. A. H. Daoud, S. M. Dosick, R. C. Whalen, J. P. Pigott, A. J. Seiwert, T. E. Russell, and H. G. Beebe Factors Related to Short Length of Stay After Carotid Endarterectomy Vascular and Endovascular Surgery, November 1, 2002; 36(6): 425 - 437. [Abstract] [PDF]
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Z. G. Nadareishvili, P. M. Rothwell, V. Beletsky, A. Pagniello, and J. W. Norris Long-term Risk of Stroke and Other Vascular Events in Patients With Asymptomatic Carotid Artery Stenosis Arch Neurol, July 1, 2002; 59(7): 1162 - 1166. [Abstract] [Full Text] [PDF]
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 H. J.M. Barnett, H. E. Meldrum, and M. Eliasziw The appropriate use of carotid endarterectomy Can. Med. Assoc. J., April 1, 2002; 166(9): 1169 - 1179. [Abstract] [Full Text] [PDF]
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 R. L. Sacco Extracranial Carotid Stenosis N. Engl. J. Med., October 11, 2001; 345(15): 1113 - 1118. [Full Text] [PDF]
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L. B. Goldstein, R. Adams, K. Becker, C. D. Furberg, P. B. Gorelick, G. Hademenos, M. Hill, G. Howard, V. J. Howard, B. Jacobs, et al. Primary Prevention of Ischemic Stroke : A Statement for Healthcare Professionals From the Stroke Council of the American Heart Association Circulation, January 2, 2001; 103(1): 163 - 182. [Full Text] [PDF]
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L. B. Goldstein, R. Adams, K. Becker, C. D. Furberg, P. B. Gorelick, G. Hademenos, M. Hill, G. Howard, V. J. Howard, B. Jacobs, et al. Primary Prevention of Ischemic Stroke : A Statement for Healthcare Professionals From the Stroke Council of the American Heart Association Stroke, January 1, 2001; 32(1): 280 - 299. [Full Text] [PDF]
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 H. J. M. Barnett and J. P. Broderick Carotid endarterectomy: Another wake-up call Neurology, September 26, 2000; 55(6): 746 - 747. [Full Text] [PDF]
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S. Chaturvedi, R. Aggarwal, and A. Murugappan Results of carotid endarterectomy with prospective neurologist follow-up Neurology, September 26, 2000; 55(6): 769 - 772. [Abstract] [Full Text] [PDF]
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J. J. Connors III, D. Seidenwurm, J. C. Wojak, R. W. Hurst, M. E. Jensen, R. Wallace, T. Tomsick, J. Barr, C. Kerber, E. Russell, et al. Treatment of Atherosclerotic Disease at the Cervical Carotid Bifurcation: Current Status and Review of the Literature AJNR Am. J. Neuroradiol., March 1, 2000; 21(3): 444 - 450. [Full Text]
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P. B. Gorelick Carotid Endarterectomy : Where Do We Draw the Line? Stroke, September 1, 1999; 30(9): 1745 - 1750. [Full Text] [PDF]
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 H. G. Beebe and B. Kritpracha Surgery for Acute Stroke: Current Status Perspectives in Vascular Surgery and Endovascular Therapy, January 1, 1999; 10(1): 85 - 93. [Abstract] [PDF]
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H. J.M. Barnett, D. W. Taylor, M. Eliasziw, A. J. Fox, G. G. Ferguson, R. B. Haynes, R. N. Rankin, G. P. Clagett, V. C. Hachinski, D. L. Sackett, et al. Benefit of Carotid Endarterectomy in Patients with Symptomatic Moderate or Severe Stenosis N. Engl. J. Med., November 12, 1998; 339(20): 1415 - 1425. [Abstract] [Full Text] [PDF]
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L. T. Smurawska, B. Bowyer, D. Rowed, R. Maggisano, P. Oh, and J. W. Norris Changing Practice and Costs of Carotid Endarterectomy in Toronto, Canada Stroke, October 1, 1998; 29(10): 2014 - 2017. [Abstract] [Full Text] [PDF]
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