(Circulation. 2001;104:12.)
© 2001 American Heart Association, Inc.
Brief Rapid Communications |
From the Columbus Clinic (N.C., R.A., C.D.M., A.C.) and San Raffaele Hospital (S.M., C.D.M., A.C.), Milano, and the Cardiology Department, Mirano Hospital (B.R., S.S., P.P.), Mirano, Italy.
Correspondence to Antonio Colombo, MD, Centro Cuore Columbus, Via Buonarotti, 48 20145 Milano, Italy. E-mail columbus{at}micronet.it
| Abstract |
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Methods and ResultsElective carotid stent implantation using 3 different types of distal filter protection devices was attempted in 88 consecutive lesions (84 patients) in the internal carotid artery that had >70% diameter stenosis (mean, 78.7±10.7%). Procedures were performed in 3 different centers. The mean age of the patients was 69±8 years, 75% were men, and 35.7% had neurological symptoms. In 86 lesions, a stent was successfully implanted (97.7%). In 83 of these 86 procedures (96.5%), it was possible to position a filter device. In 53% of filters, there was macroscopic evidence of debris. Collected material consisted of lipid-rich macrophages, fibrin material, and cholesterol clefts. Neurological complications during the procedure, in the hospital, and at 30 days of clinical follow-up occurred in only one patient (1.2%). This patient suffered a minor stroke that resolved within 1 week. Two major adverse cardiac events (2.3%) occurred during the 30 days of follow-up.
ConclusionsFilter protection during carotid artery stenting seems feasible and safe. In the present series, the incidence of neurological complications was low.
Key Words: carotid arteries angioplasty stents embolism
| Introduction |
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| Methods |
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All patients were taking aspirin (100 to 325 mg). Ticlopidine (500 mg) was started at least 48 hours before the procedure, and heparin (70 to 100 U/kg) was given intra-arterially. Arterial blood pressure was monitored during the procedure and, if needed, modulated with nitrates or dopamine. All patients were awake during the procedure. After the procedure, patients received aspirin indefinitely and ticlopidine for 1 month.
Careful neurological examination, including the NIH Stroke Scale, was performed before and after the procedure, at discharge, and at 30-day follow-up by a board-certified neurologist or by a board-certified internist. In 23 cases (26%), 1-month follow-up information was obtained by telephone call. Neurological complications were previously defined by Mathur et al.12
Carotid Stenting Procedure
Procedures were performed by following a strict
protocol that was developed in collaboration by the first operators
(A.C., C.D.M., and B.R.). Percutaneous access was
gained through the femoral or brachial (2.3%) artery. Long sheaths (80
to 90 cm long; 6 or 7 French in diameter) or coronary guiding
catheters (8 French) were advanced into the common carotid artery using
diagnostic catheters and long 0.035 or 0.038 inch support
wires placed in the external carotid artery. Stenoses were
crossed with a filter device with a diameter matching the distal
cervical internal carotid artery
(Figure 1
). Three different filter designs were used; they
included 48 Angioguard filters (55.8%; (J&J
Cordis), 30 NeuroShield filters (34.9%;
MedNova), and 8 FilterWire EX filters (9.3%; Embolic Protection, Inc;
Figure 2
). All filters were released recently, and
data on their clinical efficacy are not available. The present
study was not designed to detect differences between filters but to
evaluate the clinical feasibility and safety of protection devices
during cardiovascular
intervention.13 After
positioning of the filter, predilation with coronary balloons
was performed in 83.7% of cases. Self-expandable stents (82.3%
Carotid Wallstent, Boston Scientific-Schneider;
12.8% X-act, MedNova; and 4.7% SMART stent,
Cordis) were implanted, and all but one stent
was postdilated at a medium-high pressure (8 to 12
atm).
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Filter Device Description
The filter consists of a nitinol skeleton or
supporting wire with a polyurethane membrane that has pores with a
diameter ranging from 80 to 130 µm. The diameter of the filters
ranged from 5.0 to 7.0 mm. The filters are connected to the distal
end of a 0.014-inch wire with a floppy tip, which was used as a
guidewire during the interventional procedure. The closed filter is
advanced through the lesion and opened in the internal carotid artery
distal to the lesion. At the end of the procedure, a retrieval sheath
is advanced, and the filter is closed and removed from the
artery.
Histopathological analysis was performed on 25 filters (30.1%) by light microscopy after staining with hematoxylin-eosin and Azan-Mallory.
| Results |
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One patient (1.2%) experienced a category 1 minor stroke with partial upper limb paralysis, which resolved completely within 1 week. Four patients (4.6%) required intravenous dopamine infusion for prolonged hypotension. There were no procedural deaths and no vascular access complications.
The 30-day clinical follow-up did not reveal any further neurological events. Two major adverse cardiac events (2.3%) occurred. One patient with severe coronary artery disease suffered a massive anterior myocardial infarction 4 days after carotid stent implantation and died 3 days later with heart failure. A second patient underwent coronary angioplasty the day before carotid stenting and experienced a nonfatal, acute Q-wave myocardial infarction from subacute stent thrombosis.
The histological analysis detected particulate, atheromatous material characterized by lipid-rich macrophages, fibrin material, and cholesterol clefts.
| Discussion |
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The presence of particulate detected at microscopic analysis shows that filters could collect debris that otherwise would have embolized in cerebral vessels. It is impossible to postulate the clinical impact collected debris might have had. However, most complications during surgical endarterectomy have been related to the presence of distal embolism.4 5 6 The histological findings confirm earlier studies suggesting that material is dislocated from the atheromatous plaque during the intravascular procedure.8 9
The major cardiac events occurring in 2 patients (2.3%) underline the importance of considering the hemodynamic consequences of the procedure.14
Limitations of the Study
One limitation of the study is the absence of
transcranial Doppler monitoring during the stent
procedure. Therefore, the study does not provide any information on the
degree of embolization occurring while crossing the lesion with the
device, nor does it provide data on the efficiency of the filter in
capturing all particles dislocated during angioplasty and stenting. A
recent ex vivo study reported that 88% of embolized particles
were captured in the
filter.11 Whatever the
degree of Doppler-detectable embolization was, we should
acknowledge the low incidence of associated neurological
events.
In 26% of the procedures, 1-month follow-up evaluation was obtained by telephone contact only. Therefore, minor neurological events may be under-reported.
| Conclusions |
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Received March 23, 2001; revision received May 4, 2001; accepted May 4, 2001.
| References |
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Iyer SS, et al. Immediate and late clinical outcomes of carotid artery
stenting in patients with symptomatic and
asymptomatic carotid artery stenosis: a 5-year
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11. Ohki T, Roubin GS, Veith FJ, et al. Efficacy of a filter device in the prevention of embolic events during carotid angioplasty and stenting: an ex vivo analysis. J Vasc Surg. 1999;30:10341044.[Medline] [Order article via Infotrieve]
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