Purpose: We tested the clinical applicability, technical results, and morbidity of carotid angioplasty-stenting (CAS) in the treatment of severe stenosis of the internal carotid artery (ICA) in patients deemed to be high-risk candidates for carotid endarterectomy (CEA). Method: After an initial series (1994-1997) of 52 interventions, we adopted the use of a transfemoral access technique and self-expanding stents in late 1997. From Dec 1, 1997, to Mar 31, 2001, 135 CAS procedures were performed on 132 patients with more than 70% (symptomatic) or more than 80% (asymptomatic) stenoses of the ICA. Sixty percent of the patients had no symptoms, and 40% of patients had symptoms. The interventional technique was standardized with the use of a 7F long interventional. sheath, balloon pre-dilatation of the stenotic lesion, placement of a self-expanding stent (Wallstent in 12 patients and a SMART stent in 120 patients), and post-balloon dilatation when necessary. Brain protection devices were not used. Patients were given clopidogrel and aspirin before and after the procedure and heparin during the intervention. Results: All procedures except two were completed as planned, with access failure in three patients (2.2%). Residual in-stent stenosis of less than 20% was detected in 14 of 132 stented vessels (11%) and accepted as a satisfactory angiographic outcome. Neurologic complications included one patient with a single-episode transient ischemic attack (TIA; motor-sensory deficit of the hand) occurring 2 hours after CAS. One patient sustained a major stroke after thrombosis of the stented ICA, which occurred 3 days after the CAS procedure and 24 hours after open-heart surgery. A third patient sustained a minor stroke that began intraprocedurally after post-balloon dilatation of the stent, and a fourth patient had another minor stroke with transient aphasia (beginning during the procedure and resolving after 4 hours) and monoparesis of the hand, which resolved after I week. All stented vessels remained patent during the follow-up period (range, 2-41 months; mean, 16 +/- 9 months), with four instances of hemodynamically significant in-stent restenosis. Re-intervention with balloon angioplasty was undertaken successfully at 4 months in one patient with restenosis. The periprocedural mortality rate was 0. Conclusion: Carotid stenting can be performed with acceptable safety on carefully selected patients by using meticulous, standardized interventional techniques. It may offer a possibly superior therapeutic alternative for non-CEA candidates. Evolving technological improvements and brain protection devices are likely to enhance its role in the treatment of carotid artery disease in the future. Surgical endarterectomy remains the standard of care for most patients at the present time.
