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

Abstract

Objectives Cranial nerve injury (CNI) is the most common neurologic complication of carotid endarterectomy (CEA) and can cause significant chronic disability. Data from prior randomized trials are limited and provide no Health-Related Quality of Life (HRQOL) outcomes specific to CNI. Incidence of CNI and their outcomes for patients in CREST were examined to identify factors predictive of CNI and their impact on HRQOL. Methods Incidence of CNI, baseline and procedural characteristics, outcomes and HRQOL scores were evaluated in the 1151 patients randomized to CEA and undergoing surgery within 30 days. Patients with CNI were identified and classified using case report forms, adverse event data and clinical notes. Baseline and procedural characteristics were compared using descriptive statistics. Clinical outcomes at 1 and 12 months were analyzed. All data were adjudicated by two neurologists and a vascular surgeon. HRQOL was evaluated using the Medical Outcomes Short Form (SF-36) to assess general health and Likert Scales for disease specific outcomes at 2 weeks, 4 weeks and 12 months after CEA. The effect of CNI on SF-36 subscales was evaluated using random effects growth curve models and Likert Scale data were compared by ordinal logistic regression. Results CNI was identified in 53 (4.6%) patients. Cranial nerves injured were VII (30.2%), XII (24.5%), IX/X (41.5%) and 3.8% had Horner’s syndrome. CNI occurred in 52/1040 (5.0%) of patients receiving general anesthesia and 1/111 (0.9%) of patients operated under local anesthesia (p=0.05). No other predictive baseline or procedural factors were identified. Deficits resolved in 18 (34%) patients at 1 month and in 42 (80.8%) of 52 patients by 1 year. One patient died prior to the one year follow-up visit. HRQOL evaluation showed no statistical difference between groups with and without CNI at any interval. By Likert scale analysis, the group with CNI showed a significant difference in the difficulty eating/swallowing parameter at 2 and 4 weeks (p<0.001) but not at 1 year. Conclusions In CREST, CNI occurred in 4.6% of patients undergoing CEA with 34% resolution at 30 days and 80.8% at 1 year. The incidence of CNI was significantly higher in patients undergoing general anesthesia. CNI had a small and transient effect on HRQOL, negatively impacting only difficulty eating/swallowing at 2 and 4 weeks but not at 1 year. On the basis of these findings, we conclude that CNI is not a trivial consequence of CEA but rarely results in significant long-term disability.

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“…CREST hypothesised that increasing experience would reduce peri-operative complications after CAS. 87 After adjusting for symptom status and patient characteristics, . Thirty day outcomes after carotid artery stenting (CAS) vs. carotid endarterectomy (CEA) in 3467 asymptomatic patients randomised within seven randomised controlled trials (RCTs).…”

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