Carotid stenting with cerebral protection: First clinical experience usingthe PercuSurge GuardWire system

Purpose: To study the feasibility and safety of carotid angioplasty and ste nting using a new cerebral protection device that temporarily occludes the distal internal carotid artery (ICA). Methods: Forty-eight high-risk patients (39 men, mean age 69.1 +/- 8 years, range 54 to 86) with 53 ICA stenoses underwent percutaneous angioplasty an d stenting via the femoral approach under cerebral protection afforded by a 0.014-inch GuardWire balloon occlusion device. Mean stenosis was 82.1% +/- 9.65% (range 70 to 96) and mean lesion length was 16.0 +/- 7.5 mm (range 6 to 50). Thirty-three (62%) lesions were calcified, and 38 (72%) were ulcer ated. Thirty-two (60%) of the lesions were asymptomatic. With the occlusion balloon inflated in the distal ICA, the lesion was dilated and stented. Th e area was cleaned by aspiration and flushed via an aspiration catheter adv anced over the wire. Blood samples were collected from the external carotid artery (ECA) and analyzed to measure the size and number of particles coll ected. Computed tomography and neurological examinations were performed the day after the procedure. Results: Immediate technical success was achieved in all patients with the implantation of 38 Palmaz stents, 8 Expander stents, and 11 Wallstents. Car otid occlusion was well tolerated in all patients but 1 who had multiple, s evere carotid lesions and poor collateralization. Mean cerebral flow occlus ion time was 346 +/- 153 seconds during predilation and 303 +/- 143 seconds during stent placement. Total mean flow occlusion time was 542 +/- 243 sec onds. One immediate neurological complication (transient amaurosis) occurre d in a patient who had an anastomosis between the external carotid (EC) and ICA territories. Debris was removed in all patients with a mean 0.8-mm dia meter catheter. Conclusion: Cerebral protection with the GuardWire device is easy, safe, an d effective in protecting the brain from cerebral embolism. Larger studies are warranted.