(Stroke. 1997;28:889-890.)
© 1997 American Heart Association, Inc.
Articles |
Complication Rates for Carotid Endarterectomy
A Call to Action
From the Durham Department of Veterans Affairs Medical Center, the Center for Health Policy Research and Education, and the Division of Neurology, Duke University, Durham, NC (L.B.G.); the Section of Vascular Surgery, University of California at Los Angeles School of Medicine (W.S.M.); the Department of Neurosurgery, University of Tennessee Medical Center (Memphis) (J.T.R.); and the Department of Neurology, Wayne State University, Detroit, Mich (S.C.).
Correspondence to Larry B. Goldstein, MD, Box 3651, Duke University Medical Center, Durham, NC 27710. E-mail golds004{at}mc.duke.edu
Key Words: carotid endarterectomy • complications
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The efficacy of carotid endarterectomy (CEA) for selected patients with high-grade stenosis of the extracranial carotid artery has now been established through a series of randomized, controlled trials.1 2 3 4 5 6 The reduction in stroke risk afforded by this prophylactic procedure is highly dependent on perioperative complication rates.7 Combined stroke and death rates much exceeding 3% for patients with asymptomatic stenosis and 6% for patients with symptomatic stenosis would eliminate the benefit in stroke reduction gained through the operation.8
A systematic review of the risks of stroke and death due to CEA based on 25 studies published since 1980 estimated 30-day complication rates of 3.35% for asymptomatic stenosis and 5.18% for symptomatic stenosis (including mortality rates of 1.3% and 1.8%, respectively).9 This review included studies based on a variety of methodologies. A companion review based on 51 studies of complication rates for patients undergoing CEA for symptomatic carotid stenosis found that the risk of surgery varied systematically with the methods and authorship of the report.10 The risk of stroke and/or death was highest in studies in which the patient was assessed by a neurologist after surgery (7.7%) and lowest in studies with a single author affiliated with a surgery department (2.3%). On the basis of data from the National Hospital Discharge Survey reflecting the years 1971 through 1982, it was estimated that the perioperative mortality rate for CEA in the United States was 2.8%,11 with combined stroke and death rates estimated to be between 5.6% and 16.8%.12 Although the 30-day death rate after CEA based on Medicare claims data fell from approximately 3% in 1985 to 2.3% in 1991, the combined mortality and stroke rates were estimated to range between 5% and 11% for all Medicare patients in 1991.12 Thus, overall complication rate estimates for CEA based on many studies appearing in the medical literature may be low, and the possibility of various types of reporting bias must be recognized. In addition, the available estimates of complication rates represent mean values and are near the upper limits of acceptability based on clinical trial results. Individual surgeons and hospitals would be expected to have complication rates above and below this threshold.
Although a variety of preoperative factors may affect the risk of CEA, the skill of the surgeon is critical.13 14 15 16 Recognizing that the benefit of CEA would depend on surgical risk, recent clinical trials included strict criteria to establish the competence of the surgeon. For example, to participate in the North American Symptomatic Carotid Endarterectomy Trial, surgeons had to demonstrate a 30-day perioperative stroke and death rate of <6% for the last 50 CEAs performed within the prior 24 months.17 For participation in the Veterans Administration Cooperative Study of endarterectomy in patients with symptomatic stenosis, centers were required to have performed 25 or more of the operations annually in the 3 years before the study with perioperative morbidity and mortality rates of <6%; individual surgeons had to perform more than 10 CEAs annually within the same criteria.3 To qualify to participate in the Asymptomatic Carotid Surgery Trial, surgeons had to perform at least 12 CEAs per year with documentation of a combined neurological morbidity and mortality rate of <3.0% for asymptomatic patients and <5.0% for all indications including symptomatic patients for the last 50 consecutive CEAs.18 Each of these sets of criteria requires that the surgeon perform a prescribed volume of procedures each year within specified ranges of acceptable complication rates.
The need for careful monitoring of CEA complication rates was appreciated even before the results of recent trials were available. The Ad Hoc Committee on Carotid Surgery Standards of the American Heart Association Stroke Council issued a series of recommendations in their 1989 report.19 Upper limits of morbidity and mortality were suggested on the basis of data available at the time. In addition, the committee recommended that "all medical institutions that treat extracranial arterial occlusive disease continually monitor results of surgery through a formal ongoing audit..." and went on to describe the suggested methodology of the auditing process. The Ad Hoc Committee to the Joint Council of the Society for Vascular Surgery and the North American Chapter of the International Society for Cardiovascular Surgery also issued practice guidelines for CEA that recognized, among other factors, that the indications for the operation would depend on "...the operative morbidity and mortality rates as defined by an audit of individual surgeons proposing to do the operation."20 Indicating that it was clear that some surgeons perform CEA with low risk while others have an unacceptably high complication rate, the guidelines for CEA issued through the Multidisciplinary Consensus Statement from the Ad Hoc Committee of the American Heart Association reiterated the importance of developing methods for auditing individual surgeons' practices and limiting surgical privileges to those who can document that their results fall within an acceptable range.8 The document outlined suggested procedures for such an audit.
Although the need for ongoing assessments of surgeons' complication rates is evident, available studies show that these data are not available to physicians counseling their patients on the potential risks and benefits of CEA. The US National Survey of Physician Practices for the Secondary and Tertiary Prevention of Stroke included a random sample of physicians practicing in a wide variety of settings throughout the country.21 The survey found that only 19% of physicians reported that they knew the perioperative mortality rate, and only 15% reported knowing the perioperative stroke rate at the hospital where they perform or refer patients to have CEA. Only about 50% of neurologists and 60% of surgeons reported that they knew these rates. A second recent study surveyed the surgery program directors of medical centers in the United States with an accredited surgery residency program.22 Approximately one fifth of those responding to the survey indicated that their programs were not systematically monitoring CEA complication rates. Specific complication rates were unknown in 40% of the programs that were monitoring complications.
Despite overwhelming clinical data and several guidelines and policy statements, it is clear that data relating to surgical complication rates are not available to physicians referring their patients for CEA. Because of the failure of the current voluntary system, we feel that the auditing of complication rates should be mandated as a condition of hospital certification by the Joint Commission on Accreditation of Healthcare Organizations. As stated in the Multidisciplinary Consensus Statement from the Ad Hoc Committee of the American Heart Association, "...the design of the audit should ensure objective, unbiased, factual information regarding surgical morbidity and mortality."8 Without assurance that surgical complication rates are within acceptable limits, it is impossible to determine whether an individual patient should undergo the operation.
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Footnotes |
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The opinions expressed in this editorial are not necessarily those of the editors or of the American Heart Association.
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References |
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TopIntroductionReferences |
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