Background: Data from literature confirmed the non-trivial risk associated with carotid revascularization. The purpose of this study is to evaluate carotid endarterectomy (CEA) via a mini-invasive access (3-6 cm longitudinal) incision as a viable alternative to the traditional access via a cutaneous incision (˃6 cm) in terms of nerve sparing and neck pain/disability for patients.
Methods: We performed a prospective, observational, cohort study on 796 consecutive patients who underwent CEAs. A number of 730 patients was included in the final analysis. Patients entered in two different cohorts: CEA with 3-6 cm incision was performed in N.=398 (Group A); CEA with>6 cm incision was performed in N.=398 (Group B). Entire data set is available from 382 in group A and 348 in group B. Adverse events were recorded at 30 days, 3 and 6 months after surgery. The primary purpose of this study was to identify the incidence of cranial nerve injuries and related pain (by Northwick Park Neck Pain Questionnaire [NPq]) in both groups. Differences between groups were exploratory, only, and considered significative for P≤0.05. Secondary objectives were: death, major and minor stroke, transient ischemic attack (TIA), myocardial infarction (MI) and main duration of operation.
Results: The cumulative incidence of transient deficit of peripheral nerve in group A was 1.7% at 30 days and 19.4% in group B (RR: 0.10, 95% CI 0.07-0.1, P=0.0001) suggesting a possible benefit from mini-skin incision on nerve injuries reduction. Cranial nerve permanent injuries were identified in 0.17% of mini-incision group and 0.23% of standard group. Exploratory comparison did not demonstrate significative differences between the groups (RR: 0.72, 95% CI 0.19-2.71, P=0.63). The median NPq postoperative score was 40% in GROUP A and 79% in GROUP B (exploratory difference 39%, 95% CI 32.22-45.20%, P=0.0001, χ2: 114.007). At 6 months, NPq was 20% and 42%, respectively; exploratory differences were still present. The need to prolong the mini-incision in GROUP A to preserve the surgical outcome was 1.3%, only.
Conclusions: According to these results the mini skin incision allows a sufficient vessels exposure for dissection, endarterectomy, reconstruction of carotid artery and shunt positioning, minimizing surgical invasiveness, decreasing the incidence of temporary cervical nerve dysfunction and improving the aesthetic result with significative less pain suffered by the patients. Transverse cervical and great auricular nerves sparing decreased postoperative hypo-paresthesia in the neck, improving patient's satisfaction. These data suggest that this procedure can be considered safe. Exploratory analysis suggested that it could possibly be considered a safety alternative to standard carotid endarterectomy. A randomized controlled trial is ongoing for definitive conclusions.