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Carotid endarterectomy has been firmly established as the gold standard of therapy for symptomatic and asymptomatic patients with severe carotid stenosis, provided surgical complication rates are within prescribed limits. The procedure-related risk of stroke/death should be < 3% in asymptomatic patients and < 6% in symptomatic patients. New investigational therapies such as balloon angioplasty and stenting for carotid stenosis should be evaluated against the same standard.
The Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS) is an international multicenter randomized trial, the primary aims of which are: (1) to determine the risks and benefits of carotid and vertebral artery transluminal angioplasty; and (2) to compare these with surgical treatment (carotid endarterectomy) or best medical treatment. Through the end of October 1995, 193 patients have been randomized (90 at our center). In this article, the rationale for the trial, its design and protocol, and the experience of our institution within the trial will be discussed.

To report the experiences to date with percutaneous transluminal angioplasty (PTA) of the carotid artery and other supra-aortic vessels. A new coaxial dilatation system for carotid angioplasty with temporary balloon occlusion to avoid cerebral embolization is presented.
PTA was performed in 220 patients with 245 stenosed or occluded supra-aortic arteries; among these were 74 carotid stenoses in the proximal common (n = 5), distal common (n = 1), internal (n = 65), and external (n = 3) carotid arteries. Duplex and B-mode ultrasonography, computed tomography, magnetic resonance imaging, single-photon emission computed tomography, indium 111-labeled platelet scintigraphy, and/or angiography were used before and after PTA. Intravascular ultrasound imaging was also recently added for monitoring angioplasty results.
All patients but one with carotid lesions had symptoms of cerebrovascular insufficiency. Angioplasty was successful in 69 of the 74 carotid stenoses: proximal common (n = 5), distal common (n = 1), internal (n = 60), and external (n = 3). There were only 1 major (hemiparesis) and 2 minor complications. During the average 70-month observation period, restenosis has not occurred in any treated carotid artery. In a literature review of > 500 patients undergoing carotid angioplasty, the complication rate appears very low (mortality 0%; morbidity 2.1%) and comparable to that for carotid endarterectomy.
Results of this review suggest that percutaneous transluminal angioplasty of the carotid artery is an effective alternative method to vascular surgery, particularly for patients with comorbidities that elevate the risks of surgery.
To determine the safety and efficacy of local anesthesia for percutaneous carotid angioplasty and stenting performed via a direct common carotid access.
Deep cervical plexus blockade was used for anesthesia in 22 of 32 patients (26 males; mean age 66 years) undergoing percutaneous carotid balloon angioplasty and/or stenting via direct carotid puncture. Local anesthesia was selected according to patient preference (n = 9); advanced age (n = 4); ischemic heart disease (n = 4); intended extracorporeal circulation for unstable angina (n = 3); and an incompetent circle of Willis (n = 2). The technique involved injection of bupivacaine hydrochloride along the C2, C3, and C4 transverse processes. No superficial cervical plexus blockade was used.
No complications of anesthesia were observed, though there were cases in which surgery became necessary under local anesthesia for angioplasty-related complications. These conversions were accomplished without difficulty.
Cervical nerve blockade appears to be a safe and effective anesthetic method for endovascular carotid interventions performed percutaneously through direct carotid puncture.
For 15 years, balloon angioplasty has been cautiously applied to carotid artery occlusive lesions. Procedural results have, by and large, been satisfactory, but the potential for significant neurologic complications and a dearth of controlled studies with long-term follow-up have impeded the development of carotid angioplasty until recently.
This review of the literature chronicles the slow but steady evolutionary pace of carotid angioplasty from its beginnings in 1980 to today's shifting focus to the use of stents. Based on these existing reports and significant personal experience, the advantages and risks of endoluminal carotid interventions are enumerated, along with suggested criteria for the application of carotid angioplasty.
To evaluate the feasibility, safety, and efficacy of intravascular stents in the treatment of extracranial carotid artery occlusive disease.
According to protocol, stent therapy was offered to symptomatic patients with ≥ 70% arteriographically defined carotid stenoses or ulcerative lesions and, after September 1994, to asymptomatic patients with ≥ 75% stenoses. From April 1993 to September 1995, 110 nonconsecutive patients (79 males; mean age 72 years, range 45 to 85) consented to participate in the study. The majority (79 [72%]) were asymptomatic. Lesions meeting the treatment criteria were in the proximal common (n = 3); mid common (n = 12); distal common (n = 8); internal (ICA) (n = 92); and external (n = 2) carotid arteries. Seven patients had bilateral ICA stenoses, and 17 patients were treated for postsurgical recurrent disease. The mean lesion length and diameter stenosis for all lesions were 12.4 ± 9.2 mm and 86.5% ± 10.6%, respectively.
The procedures were performed either via direct percutaneous access to the cervical common carotid artery or through a retrograde femoral artery approach. Standard balloon dilation preceded deployment of balloon-expandable stents in most cases. No postprocedural anticoagulation was used (aspirin only).
In 110 patients (117 arteries) intended for treatment, 109 (99.0%) (116 arteries [99.1%]) were successfully treated with 129 stents (128 Palmaz, 1 Wallstent). One percutaneous procedure failed (0.9%) for technical reasons (stent could not be deployed) and was converted to carotid endarterectomy. Minor complications included 4 cases of spasm (successfully treated with papaverine); 1 flow-limiting dissection (stented); and 6 access-site problems. There were 7 strokes (2 major, 5 reversible) (6.4%) and 5 minor transient events (4.5%) that resolved within 24 hours. Three patients were converted to endarterectomy (2.7%) prior to discharge; 1 stroke patient expired (0.9%), and another patient died of an unrelated cardiac event in hospital. In the 30-day postprocedural period, 2 ICA stents occluded (patients asymptomatic). Clinical success at 30 days (no technical failure, death, endarterectomy, stroke, or occlusion) was 89.1% (98/110).
Over a mean 7.6-month follow-up (range 2 to 31), no new neurological symptoms developed. Another stent occlusion at 2 months and one case of flow-limiting intimal hyperplasia at 7 months were detected on routine duplex scanning in asymptomatic patients. Life-table analysis shows an 89% cumulative primary patency rate.
Based on this early experience, carotid stenting appears feasible from a technical standpoint, with good midterm patency. However, the incidence of neurological sequelae is a serious problem. Technical enhancements and a more aggressive antiplatelet regimen may have a positive impact on these events.
To illustrate the utility of intravascular ultrasound (IVUS) imaging during endoluminal interventions in the carotid artery.
A patient with symptomatic internal carotid artery occlusive disease was treated with balloon angioplasty and evaluated with both angiography (interpreted as a widely patent outcome) and IVUS, which identified a residual 70% cross-sectional area stenosis. A stent was placed across the lesion, producing a 70% increase in the lumen as documented by IVUS in comparison to the cross-sectional area of the reference vessel. Postprocedural angiography of the stented segment showed only an approximate 20% increase in diameter.
This study highlights the utility of IVUS for accurate assessment of angioplasty outcome and for quantitative assessment of luminal volume following intervention and stent placement. The case emphasizes the need for IVUS as an integral part of the procedure to ensure adequate treatment and to accurately document the residual lesion for assessment of recurrence phenomena at follow-up.
Carotid restenosis has been a well-recognized, though not well-understood, long-term complication of carotid endarterectomy. Various factors contribute to recurrent stenosis, but the chief cause is technical faults during the primary procedure. Redo endarterectomy or graft reconstruction are the traditional and most effective procedures for treating symptomatic or high-grade (> 80%) asymptomatic restenotic lesions.
To reduce the potential for carotid restenosis, eversion endarterectomy is recommended as the technique of choice for de novo carotid disease treatment. Angioscopy is useful in detecting correctable technical errors that could predispose to restenosis.
To report the results of balloon angioplasty in recurrent carotid occlusive disease and evaluate the potential for stent implantation.
Between April 1991 and September 1995, 15 patients with carotid restenosis underwent 17 endoluminal procedures in 3 common carotid and 14 internal carotid arteries. Two postdilation complications (dissection and acute occlusion) required prompt stenting; one common carotid artery was stented for postdilation residual stenosis. One recurrent lesion was also stented 6 months after initial angioplasty.
One stroke, 1 silent cerebral infarction, and 3 transient ischemic attacks occurred in the balloon angioplasty patients (33% neurological complication rate). The common carotid stent patient died 3 days postoperatively due to hyperperfusion syndrome. Long-term follow-up in two stent patients showed no restenosis at 18 and 48 months, respectively. The 11 balloon angioplasty patients likewise have not demonstrated restenosis.
Balloon angioplasty alone appears too risky for treating recurrent carotid disease. Stents may offer a safer alternative, particularly when implanted primarily.





