Objective: The purpose of this study was to evaluate the effectiveness and demonstrate the advantages of a new technique for carotid angioplasty and stenting (CAS) with proximal cerebral protection through a direct transcervical approach, as compared with a percutaneous transfemoral approach.
Methods: CAS procedures were carried out in 25 consecutive patients, 4 with the femoral approach and 21 through a 2-cm incision at the base of the neck, with the patient under local anesthesia. For transcervical occlusion and protective shunting (TOPS), a short 9F sheath was inserted directly into the common carotid artery and connected to a 6F sheath placed percutaneously in the ipsilateral internal jugular vein. After clamping the common carotid artery proximal to the 9F sheath, internal carotid artery blood flow reversal was confirmed or an occluding external carotid balloon was placed. A filter interposed between the arterial and venous sheaths collected embolic debris from transcarotid manipulations. The arterial puncture was directly repaired with suture. Neurologic status was assessed with the National Institutes of Health stroke scale by an independent neurology consultant before and after the procedure.
Results: One of the four percutaneous femoral approaches that failed because of tortuous anatomy was successfully treated with TOPS. Angiographic confirmation demonstrating resolution of asymptomatic (>80%; n = 12) stenosis or symptomatic (>60%; n = 12) stenosis was achieved in all patients with stents. A 0% technical failure rate and 0% combined 30-day stroke or mortality rate were achieved in all CAS attempted with TOPS. There were no hematomas in the cervical group, despite pretreatment with clopidogrel bisulfate and heparin, and one hematoma in the femoral group after failure of a Perclose arterial closure device. In one of the patients in the femoral group bilateral cholesterol emboli to the toes developed.
Conclusion: TOPS solves problems of access, embolization into the cerebral and peripheral circulation, and specialized cerebral protection devices, and enables secure closure of the access vessel in patients given anticoagulation therapy. TOPS may provide a safer, more effective, economical means for performing CAS.