Incidence, Impact, and Predictors of Cranial Nerve Palsy and Haematoma Following Carotid Endarterectomy in the International Carotid Stenting Study

Abstract

ObjectiveCranial 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.Materials and methodsA 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.ResultsOf 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.ConclusionsCNP 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.

Incidence, outcomes, and effect on quality of life of cranial nerve injury in the Carotid Revascularization Endarterectomy versus Stenting Trial

“…In previous reports from clinical trials, the incidence of CNI was 5.1 – 8.6% 10–13, 23 , consistent with these findings. Post-operative evaluation using laryngoscopy or by otolaryngologists were not systematically performed in this or any of the reference trials so the diagnosis of CNIs was made on examination by neurologists or by the surgeons who performed the operations.…”

“…Few reports have included data regarding the timing of resolution of the deficits. For example, in the report from the International Carotid Stenting Study (ICSS) 13,23 , the incidence of CNI was 5.5% and little detail was provided regarding resolution of the deficits but two patients required percutaneous feeding tubes, at least temporarily. In CREST, we found that 34% of the injuries were resolved at the 1-month follow-up visit and 80.8% had resolved by the 12-month follow-up visit.…”

Dual Antiplatelet Therapy Prior to Expedited Carotid Surgery Reduces Recurrent Events Prior to Surgery without Significantly Increasing Peri-operative Bleeding Complications

“…23 Other single centre studies have also reported that performing CEA in patients on dual antiplatelet therapy is not associated with an increase in reexploration for neck haematomas, 24 while the International Carotid Stenting Study reported a prevalence of 3.4% for neck haematomas requiring re-exploration following 821 CEAs. 25 It is, however, conceded that the spontaneous shin haematoma was probably a direct consequence of dual antiplatelet therapy, but this was the only example of spontaneous peripheral bleeding in this series and there were no cases of acute gastrointestinal haemorrhage.…”

Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): a randomised controlled trial with cost-effectiveness analysis

“…Austin Health, Heidelberg [46]: M Brooks, B Chambers (PI), A Chan, P Chu, D Clark, H Dewey, G Donnan, G Fell, M Hoare, M Molan, A Roberts and N Roberts.…”

“…46 We analysed the effects of patient factors and surgical technique on the risk, and impact on disability, of cranial nerve palsy or haematoma in the surgical arm, including only patients allocated to endarterectomy in whom the procedure was actually initiated (per-protocol analysis). Patients who crossed over to CEA, received CEA after an attempt at CAS or received medical therapy instead of CAS were excluded.…”