title: Incidence, impact, and predictors of cranial nerve palsy and haematoma following carotid endarterectomy in the international carotid stenting study.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Institute of Neurology, University College London, London, UK.
authors.forename: D
authors.initials: D
authors.lastname: Doig
authors.affiliation: Department of Biostatistics and Bioinformatics and Duke Global Health Institute, Duke University, Durham, NC, USA.
authors.forename: E L
authors.initials: EL
authors.lastname: Turner
authors.affiliation: Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: J
authors.initials: J
authors.lastname: Dobson
authors.affiliation: Institute of Neurology, University College London, London, UK.
authors.forename: R L
authors.initials: RL
authors.lastname: Featherstone
authors.affiliation: Department of Vascular Surgery, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: G J
authors.initials: GJ
authors.lastname: de Borst
authors.affiliation: Institute of Neurology, University College London, London, UK. Electronic address: martin.brown@ucl.ac.uk.
authors.forename: M M
authors.initials: MM
authors.lastname: Brown
authors.affiliation: Department of Surgical and Interventional Sciences, University College London, London, UK.
authors.forename: T
authors.initials: T
authors.lastname: Richards
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000379:methods; D016893:Carotid Stenosis / Q000601:surgery*; D003389:Cranial Nerve Diseases / Q000453:epidemiology*; D016894:Endarterectomy, Carotid / Q000009:adverse effects*; D005260:Female; D006406:Hematoma / Q000453:epidemiology* / Q000209:etiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
keywords: Carotid artery stenosis; Carotid atherosclerosis; Carotid endarterectomy; Cranial nerves; Haematoma