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      Safety of embolic protection device-assisted and unprotected intravascular ultrasound in evaluating carotid artery atherosclerotic lesions

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          Summary

          Background

          Significant atherosclerotic stenosis of internal carotid artery (ICA) origin is common (5–10% at ≥60 years). Intravascular ultrasound (IVUS) enables high-resolution (120 μm) plaque imaging, and IVUS-elucidated features of the coronary plaque were recently shown to be associated with its symptomatic rupture/thrombosis risk. Safety of the significant carotid plaque IVUS imaging in a large unselected population is unknown.

          Material/Methods

          We prospectively evaluated the safety of embolic protection device (EPD)-assisted vs. unprotected ICA-IVUS in a series of consecutive subjects with ≥50% ICA stenosis referred for carotid artery stenting (CAS), including 104 asymptomatic (aS) and 187 symptomatic (S) subjects (age 47–83 y, 187 men). EPD use was optional for IVUS, but mandatory for CAS.

          Results

          Evaluation was performed of 107 ICAs (36.8%) without EPD and 184 with EPD. Lesions imaged under EPD were overall more severe (peak-systolic velocity 2.97±0.08 vs. 2.20±0.08m/s, end-diastolic velocity 1.0±0.04 vs. 0.7±0.03 m/s, stenosis severity of 85.7±0.5% vs. 77.7±0.6% by catheter angiography; mean ±SEM; p<0.01 for all comparisons) and more frequently S (50.0% vs. 34.6%, p=0.01). No ICA perforation or dissection, and no major stroke or death occurred. There was no IVUS-triggered cerebral embolization. In the procedures of (i) unprotected IVUS and no CAS, (ii) unprotected IVUS followed by CAS (filters – 39, flow reversal/blockade – 3), (iii) EPD-protected (filters – 135, flow reversal/blockade – 48) IVUS+CAS, TIA occurred in 1.5% vs. 4.8% vs. 2.7%, respectively, and minor stroke in 0% vs. 2.4% vs. 2.1%, respectively. EPD intolerance (on-filter ICA spasm or flow reversal/blockade intolerance) occurred in 9/225 (4.0%). IVUS increased the procedure duration by 7.27±0.19 min.

          Conclusions

          Carotid IVUS is safe and, for the less severe lesions in particular, it may not require mandatory EPD use. High-risk lesions can be safely evaluated with IVUS under flow reversal/blockade.

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          Most cited references60

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          Neurologic complications of cerebral angiography: prospective analysis of 2,899 procedures and review of the literature.

          To prospectively identify risk factors for neurologic complications related to cerebral angiography. A total of 2,899 consecutive cerebral digital subtraction angiograms obtained with nonionic contrast material were prospectively evaluated. Neurologic complications were categorized as transient ( 7 days). The neurologic complication rate was correlated with patient age, type of indication for catheter angiography, medical history, fluoroscopic time, number and size of catheters, type and number of vessels injected, operator experience, and the quartile in which the study was performed. The correlations were statistically analyzed with Fisher exact tests and a multiple logistic regression model. There were 39 (1.3%) neurologic complications in 2,899 procedures; 20 were transient (0.7%), five (0.2%) were reversible, and 14 (0.5%) were permanent. Neurologic complications were significantly more common in patients 55 years of age or older (25 of 1,361; 1.8%) (P =.035), in patients with cardiovascular disease (CVD) (20 of 862; 2.3%) (P =.004), and when fluoroscopic times were 10 minutes or longer (24 of 1,238; 1.9%) (P =.022). The neurologic complication rate was higher in procedures performed by fellows alone (24 of 1,878; 1.3%) compared with that when staff alone performed the procedures (three of 598; 0.5%), but the difference was not significant (P =.172). Neurologic complications were lower in the fourth quartile of the study (six of 171; 0.9%) compared with the first quartile (16 of 776; 2.1%), which was likely due to fewer patients being examined for carotid stenosis or ischemic stroke and fewer patients with CVD (P =.085). Age-related vascular disease accounted for the failure to lower the neurologic complication rate of cerebral angiography despite technical advances. Copyright RSNA, 2003
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            Asymptomatic embolisation for prediction of stroke in the Asymptomatic Carotid Emboli Study (ACES): a prospective observational study

            Summary Background Whether surgery is beneficial for patients with asymptomatic carotid stenosis is controversial. Better methods of identifying patients who are likely to develop stroke would improve the risk–benefit ratio for carotid endarterectomy. We aimed to investigate whether detection of asymptomatic embolic signals by use of transcranial doppler (TCD) could predict stroke risk in patients with asymptomatic carotid stenosis. Methods The Asymptomatic Carotid Emboli Study (ACES) was a prospective observational study in patients with asymptomatic carotid stenosis of at least 70% from 26 centres worldwide. To detect the presence of embolic signals, patients had two 1 h TCD recordings from the ipsilateral middle cerebral artery at baseline and one 1 h recording at 6, 12, and 18 months. Patients were followed up for 2 years. The primary endpoint was ipsilateral stroke and transient ischaemic attack. All recordings were analysed centrally by investigators masked to patient identity. Findings 482 patients were recruited, of whom 467 had evaluable recordings. Embolic signals were present in 77 of 467 patients at baseline. The hazard ratio for the risk of ipsilateral stroke and transient ischaemic attack from baseline to 2 years in patients with embolic signals compared with those without was 2·54 (95% CI 1·20–5·36; p=0·015). For ipsilateral stroke alone, the hazard ratio was 5·57 (1·61–19·32; p=0·007). The absolute annual risk of ipsilateral stroke or transient ischaemic attack between baseline and 2 years was 7·13% in patients with embolic signals and 3·04% in those without, and for ipsilateral stroke was 3·62% in patients with embolic signals and 0·70% in those without. The hazard ratio for the risk of ipsilateral stroke and transient ischaemic attack for patients who had embolic signals on the recording preceding the next 6-month follow-up compared with those who did not was 2·63 (95% CI 1·01–6·88; p=0·049), and for ipsilateral stroke alone the hazard ratio was 6·37 (1·59–25·57; p=0·009). Controlling for antiplatelet therapy, degree of stenosis, and other risk factors did not alter the results. Interpretation Detection of asymptomatic embolisation on TCD can be used to identify patients with asymptomatic carotid stenosis who are at a higher risk of stroke and transient ischaemic attack, and also those with a low absolute stroke risk. Assessment of the presence of embolic signals on TCD might be useful in the selection of patients with asymptomatic carotid stenosis who are likely to benefit from endarterectomy. Funding British Heart Foundation.
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              ESVS guidelines. Invasive treatment for carotid stenosis: indications, techniques.

              The European Society for Vascular Surgery brought together a group of experts in the field of carotid artery disease to produce updated guidelines for the invasive treatment of carotid disease. The recommendations were rated according to the level of evidence. Carotid endarterectomy (CEA) is recommended in symptomatic patients with >50% stenosis if the perioperative stroke/death rate is <6% [A], preferably within 2 weeks of the patient's last symptoms [A]. CEA is also recommended in asymptomatic men <75 years old with 70-99% stenosis if the perioperative stroke/death risk is <3% [A]. The benefit from CEA in asymptomatic women is significantly less than in men [A]. CEA should therefore be considered only in younger, fit women [A]. Carotid patch angioplasty is preferable to primary closure [A]. Aspirin at a dose of 75-325 mg daily and statins should be given before, during and following CEA. [A] Carotid artery stenting (CAS) should be performed only in high-risk for CEA patients, in high-volume centres with documented low peri-operative stroke and death rates or inside a randomized controlled trial [C]. CAS should be performed under dual antiplatelet treatment with aspirin and clopidogrel [A]. Carotid protection devices are probably of benefit [C].
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                Author and article information

                Journal
                Med Sci Monit
                Med. Sci. Monit
                Medical Science Monitor
                Medical Science Monitor : International Medical Journal of Experimental and Clinical Research
                International Scientific Literature, Inc.
                1234-1010
                1643-3750
                2012
                01 February 2012
                : 18
                : 2
                : MT7-MT18
                Affiliations
                [1 ]Department of Cardiac and Vascular Diseases, Jagiellonian University, Cracow, Poland
                [2 ]John Paul II Hospital, Cracow, Poland
                [3 ]Clinical Neurology Centre, Cracow, Poland
                [4 ]Department of Cardiovascular Surgery – Division of Endovascular Surgery, Jagiellonian University, Cracow, Poland
                [5 ]Department of Hemodynamics and Angiocardiography, Jagiellonian University, Cracow, Poland
                Author notes
                Piotr Musialek, Department of Cardiac and Vascular Diseases, John Paul II Hospital, Jagiellonian University, Pradnicka 80 St., 31-202 Cracow, Poland, e-mail: pmusialek@ 123456szpitaljp2.krakow.pl
                [A]

                Study Design

                [B]

                Data Collection

                [C]

                Statistical Analysis

                [D]

                Data Interpretation

                [E]

                Manuscript Preparation

                [F]

                Literature Search

                [G]

                Funds Collection

                Article
                882452
                10.12659/MSM.882452
                3560589
                22293887
                24391ee1-561c-4521-bba5-cb99cbebb133
                © Med Sci Monit, 2012

                This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported License.

                History
                : 24 March 2011
                : 27 June 2011
                Categories
                Diagnostics and Medical Technology

                intravascular ultrasound,carotid artery stenosis,embolic protection device

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