Moore W S, Barnett H J, Beebe H G, Bernstein E F, Brener B J, Brott T, Caplan L R, Day A, Goldstone J, Hobson R W
Office of Scientific Affairs, American Heart Association, Dallas, TX 75231-4596.
Circulation. 1995 Jan 15;91(2):566-79. doi: 10.1161/01.cir.91.2.566.
Indications for carotid endarterectomy have engendered considerable debate among experts and have resulted in publication of retrospective reviews, natural history studies, audits of community practice, position papers, expert opinion statements, and finally prospective randomized trials. The American Heart Association assembled a group of experts in a multidisciplinary consensus conference to develop this statement.
A conference was held July 16-18, 1993, in Park City, Utah, that included recognized experts in neurology, neurosurgery, vascular surgery, and healthcare planning. A program of critical topics was developed, and each expert presented a talk and provided the chairman with a summary statement. From these summary statements a document was developed and edited onsite to achieve consensus before final revision.
The first section of this document reviews the natural history, methods of patient evaluation, options for medical management, results of surgical management, data from position statements, and results to date of prospective randomized trials for symptomatic and asymptomatic patients with carotid artery disease. The second section divides 96 potential indications for carotid endarterectomy, based on surgical risk, into four categories: (1) Proven: This is the strongest indication for carotid endarterectomy; data are supported by results of prospective contemporary randomized trials. (2) Acceptable but not proven: a good indication for operation; supported by promising but not scientifically certain data. (3) Uncertain: Data are insufficient to define the risk/benefit ratio. (4) Proven inappropriate: Current data are adequate to show that the risk of surgery outweighs any benefit.
Indications for carotid endarterectomy in symptomatic good-risk patients with a surgeon whose surgical morbidity and mortality rate is less than 6% are as follows. (1) Proven: one or more TIAs in the past 6 months and carotid stenosis > or = 70% or mild stroke within 6 months and a carotid stenosis > or = 70%; (2) acceptable but not proven: TIAs within the past 6 months and a stenosis 50% to 69%, progressive stroke and a stenosis > or = 70%, mild or moderate stroke in the past 6 months and a stenosis 50% to 69%, or carotid endarterectomy ipsilateral to TIAs and a stenosis > or = 70% combined with required coronary artery bypass grafting; (3) uncertain: TIAs with a stenosis < 50%, mild stroke and stenosis < 50%, TIAs with a stenosis < 70% combined with coronary artery bypass grafting, or symptomatic, acute carotid thrombosis; (4) proven inappropriate: moderate stroke with stenosis < 50%, not on aspirin; single TIA, < 50% stenosis, not on aspirin; high-risk patient with multiple TIAs, not on aspirin, stenosis < 50%; high-risk patient, mild or moderate stroke, stenosis < 50%, not on aspirin; global ischemic symptoms with stenosis < 50%; acute dissection, asymptomatic on heparin. Indications for carotid endarterectomy in asymptomatic good-risk patients performed by a surgeon whose surgical morbidity and mortality rate is less than 3% are as follows. (1) Proven: none. As this statement went to press, the National Institute of Neurological Disorders and Stroke issued a clinical advisory stating that the Institute has halted the Asymptomatic Carotid Atherosclerosis Study (ACAS) because of a clear benefit in favor of surgery for patients with carotid stenosis > or = 60% as measured by diameter reduction. When the ACAS report is published, this indication will be recategorized as proven. (2) acceptable but not proven: stenosis > 75% by linear diameter; (3) uncertain: stenosis > 75% in a high-risk patient/surgeon (surgical morbidity and mortality rate > 3%), combined carotid/coronary operations, or ulcerative lesions without hemodynamically significant stenosis; (4) proven inappropriate: operations with a combined stroke morbidity and mortality > 5%.
颈动脉内膜切除术的适应证在专家中引发了相当多的争论,并导致了回顾性综述、自然史研究、社区实践审计、立场文件、专家意见声明的发表,最终还有前瞻性随机试验。美国心脏协会召集了一组专家参加多学科共识会议以制定本声明。
1993年7月16日至18日在犹他州帕克城举行了一次会议,参会人员包括神经病学、神经外科、血管外科和医疗保健规划领域的知名专家。制定了一个关键主题计划,每位专家进行了发言并向主席提供了一份总结声明。根据这些总结声明编写并在现场编辑了一份文件,以在最终修订前达成共识。
本文件的第一部分回顾了颈动脉疾病有症状和无症状患者的自然史、患者评估方法、药物治疗选择、手术治疗结果、立场声明数据以及前瞻性随机试验的最新结果。第二部分根据手术风险将96种颈动脉内膜切除术的潜在适应证分为四类:(1)已证实:这是颈动脉内膜切除术的最强适应证;数据得到当代前瞻性随机试验结果的支持。(2)可接受但未证实:手术的良好适应证;有前景但未得到科学确证的数据支持。(3)不确定:数据不足以确定风险/效益比。(4)已证实不适当:当前数据足以表明手术风险超过任何益处。
对于手术发病率和死亡率低于6%的外科医生治疗的有症状低风险患者,颈动脉内膜切除术的适应证如下。(1)已证实:过去6个月内有一次或多次短暂性脑缺血发作(TIA)且颈动脉狭窄≥70%,或6个月内有轻度卒中且颈动脉狭窄≥70%;(2)可接受但未证实:过去6个月内有TIA且狭窄50%至69%,进行性卒中且狭窄≥70%,过去6个月内有轻度或中度卒中且狭窄50%至69%,或与TIA同侧的颈动脉内膜切除术且狭窄≥70%并伴有所需的冠状动脉旁路移植术;(3)不确定:狭窄<50%的TIA,狭窄<50%的轻度卒中,狭窄<70%的TIA并伴有冠状动脉旁路移植术,或有症状的急性颈动脉血栓形成;(4)已证实不适当:狭窄<50%的中度卒中,未服用阿司匹林;单次TIA,狭窄<50%,未服用阿司匹林;有多次TIA的高风险患者,未服用阿司匹林,狭窄<50%;高风险患者,轻度或中度卒中,狭窄<50%,未服用阿司匹林;狭窄<50%的全身性缺血症状;急性夹层,肝素治疗无症状。对于手术发病率和死亡率低于3%的外科医生治疗的无症状低风险患者,颈动脉内膜切除术的适应证如下。(1)已证实:无。在本声明付印时,美国国立神经疾病和中风研究所发布了一份临床咨询意见,称该研究所已停止无症状颈动脉粥样硬化研究(ACAS),因为根据直径缩小测量,对于颈动脉狭窄≥60%的患者,手术有明显益处。当ACAS报告发表时,这一适应证将重新归类为已证实。(2)可接受但未证实:直线直径狭窄>75%;(3)不确定:高风险患者/外科医生(手术发病率和死亡率>3%)中狭窄>75%,联合颈动脉/冠状动脉手术,或无血流动力学显著狭窄的溃疡性病变;(4)已证实不适当:卒中合并发病率和死亡率>5%的手术。