Doig D, Turner E L, Dobson J, Featherstone R L, de Borst G J, Brown M M, Richards T
Institute of Neurology, University College London, London, UK.
Department of Biostatistics and Bioinformatics and Duke Global Health Institute, Duke University, Durham, NC, USA.
Eur J Vasc Endovasc Surg. 2014 Nov;48(5):498-504. doi: 10.1016/j.ejvs.2014.08.002. Epub 2014 Oct 2.
Cranial nerve palsy (CNP) and neck haematoma are complications of carotid endarterectomy (CEA). The effects of patient factors and surgical technique were analysed on the risk, and impact on disability, of CNP or haematoma in the surgical arm of the International Carotid Stenting Study (ICSS), a randomized controlled clinical trial of stenting versus CEA in patients with symptomatic carotid stenosis.
A per-protocol analysis of early outcome in patients receiving CEA in ICSS is reported. Haematoma was defined by the surgeon. CNP was confirmed by an independent neurologist. Factors associated with the risk of CNP and haematoma were investigated in a binomial regression analysis.
Of the patients undergoing CEA, 45/821 (5.5%) developed CNP, one of which was disabling (modified Rankin score = 3 at 1 month). Twenty-eight (3.4%) developed severe haematoma. Twelve patients with haematoma also had CNP, a significant association (p < .01). Independent risk factors modifying the risk of CNP were cardiac failure (risk ratio [RR] 2.66, 95% CI 1.11 to 6.40), female sex (RR 1.80, 95% CI 1.02 to 3.20), the degree of contralateral carotid stenosis, and time from randomization to treatment >14 days (RR 3.33, 95% CI 1.05 to 10.57). The risk of haematoma was increased in women, by the prescription of anticoagulant drugs pre-procedure and in patients with atrial fibrillation, and was decreased in patients in whom a shunt was used and in those with a higher baseline cholesterol level.
CNP remains relatively common after CEA, but is rarely disabling. Women should be warned about an increased risk. Attention to haemostasis might reduce the incidence of CNP. ICSS is a registered clinical trial: ISRCTN 25337470.
颅神经麻痹(CNP)和颈部血肿是颈动脉内膜切除术(CEA)的并发症。在国际颈动脉支架置入研究(ICSS)的外科手术组中,分析了患者因素和手术技术对CNP或血肿风险及其对残疾影响的作用,ICSS是一项针对有症状颈动脉狭窄患者进行支架置入与CEA对比的随机对照临床试验。
报告了ICSS中接受CEA治疗患者的按方案分析早期结局。血肿由外科医生定义。CNP由独立神经科医生确诊。在二项回归分析中研究与CNP和血肿风险相关的因素。
接受CEA治疗的患者中,4例/821例(5.5%)发生CNP,其中1例导致残疾(1个月时改良Rankin评分=3)。28例(3.4%)发生严重血肿。12例有血肿的患者也有CNP,存在显著相关性(p<0.01)。影响CNP风险的独立危险因素为心力衰竭(风险比[RR]2.66,95%可信区间1.11至6.40)、女性(RR 1.80,95%可信区间1.02至3.20)、对侧颈动脉狭窄程度以及从随机分组到治疗的时间>14天(RR 3.33,95%可信区间1.05至10.57)。女性、术前使用抗凝药物以及房颤患者发生血肿的风险增加,而使用分流器的患者和基线胆固醇水平较高的患者发生血肿的风险降低。
CEA术后CNP仍然相对常见,但很少导致残疾。应告知女性风险增加。注意止血可能会降低CNP的发生率。ICSS是一项注册临床试验:ISRCTN 25337470。