Dataset Information

Optimal cut-off criteria for duplex ultrasound for the diagnosis of restenosis in stented carotid arteries: review and protocol for a diagnostic study.

ABSTRACT:

Background

Carotid angioplasty with stenting is a relatively new, increasingly used, less-invasive treatment for the treatment of symptomatic carotid artery stenosis. It is being evaluated in ongoing and nearly finished randomized trials. An important factor in the evaluation of stents is the occurrence of in-stent restenosis. An un-stented carotid artery is likely to have a more elastic vessel wall than a stented one, even if stenosis is present. Therefore, duplex ultrasound cut-off criteria for the degrees of an in-stent stenosis, based on blood velocity parameters, are probably different from the established cut-offs used for un-stented arteries. Routine criteria can not be applied to stented arteries but new criteria need to be established for this particular purpose.

Methods/design

Current literature was systematically reviewed. From the selected studies, the following data were extracted: publication year, population size, whether the study was prospective, duplex ultrasound cut-off criteria reported, which reference test was used, and if there was an indication for selection bias and for verification bias in particular. Previous studies often were retrospective, or the reference test (DSA or CTA) was carried out only when a patient was suspected of having restenosis at DUS, which may result in verification bias. :

Results

In general, the velocity cut-off values for stenosis measurements in stented arteries were higher than those reported for unstented arteries. Previous studies often were retrospective, or the reference test (DSA or CTA) was carried out only when a patient was suspected of having restenosis at DUS, which may result in verification bias.

Discussion

To address the deficiencies of the existing studies, we propose a prospective cohort study nested within the International Carotid Stenting Study (ICSS), an international multi-centre trial in which over 1,700 patients have been randomised between stenting and CEA. In this cohort we will enrol a minimum of 300 patients treated with a stent. All patients undergo regular DUS examination at the yearly follow-up visit according to the ICSS protocol. To avoid verification bias, an additional computed tomography angiography (CTA) will be performed as a reference test in all consecutive patients, regardless of the degree of stenosis on the initial DUS test.

SUBMITTER: Nederkoorn PJ

PROVIDER: S-EPMC2722571 | biostudies-literature | 2009 Jul

REPOSITORIES: biostudies-literature

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Publications

Optimal cut-off criteria for duplex ultrasound for the diagnosis of restenosis in stented carotid arteries: review and protocol for a diagnostic study.

Nederkoorn Paul J PJ Brown Martin M MM

BMC neurology 20090722

<h4>Background</h4>Carotid angioplasty with stenting is a relatively new, increasingly used, less-invasive treatment for the treatment of symptomatic carotid artery stenosis. It is being evaluated in ongoing and nearly finished randomized trials. An important factor in the evaluation of stents is the occurrence of in-stent restenosis. An un-stented carotid artery is likely to have a more elastic vessel wall than a stented one, even if stenosis is present. Therefore, duplex ultrasound cut-off cri ...[more]

PMID: 19624830

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Project description:This study aimed to describe the duplex ultrasound (DUS) findings associated with carotid restenosis after carotid endarterectomy (CEA) and to determine whether carotid restenosis is associated with the clinical outcomes of CEA. Between January 2007 and December 2016, a total of 660 consecutive patients who underwent 717 CEAs were followed up at our hospital with DUS surveillance for at least 3 years after CEA. These patients were analyzed retrospectively for this study. Following CEA, restenosis was defined as the development of ≥50% stenosis, diagnosed on the basis of DUS findings of the luminal narrowing and velocity criteria. The study outcomes were defined as restenosis of the ipsilateral carotid artery after CEA and late (>30days) fatal or nonfatal stroke ipsilateral to the carotid restenosis. During the median follow-up period of 74 months, the restenosis incidence was 2.8% (20/717), and there were 2 strokes (2/20, 10%) ipsilateral to the restenosis after CEA; reintervention was performed for 11 patients with carotid restenosis (55%). Within 2 years after CEA, restenosis was identified in 9 cases (45%, 9/20), and 8 reinterventions (72.7%, 8/11) were performed. According to DUS findings, the morphologic characteristics of carotid restenosis were different from the preoperative plaque morphology. Among the 20 carotid restenosis cases, we observed the following DUS patterns: homogenous isoechoic restenosis (n = 14, 70%), homogenous hypoechoic (n = 2, 10%), isoechoic with hypoechoic surface (n = 3, 15%), and hypoechoic with isoechoic surface (n = 1, 5%). Although 9 carotid restenosis patients received prophylactic reintervention to mitigate the progression of restenosis, the 2 symptomatic restenosis patients had isoechoic lesions with hypoechoic surfaces on DUS. On Kaplan-Meier survival analyses, in terms of stroke-free survival rates, there was a higher risk of stroke among patients with carotid restenosis compared with patients without restenosis, with a non-significant trend (P = 0.051). In conclusion, most carotid restenoses were identified within 2 years after CEA, and there was a non-significant trend toward a higher risk of stroke among patients with carotid restenosis.

Project description:Diagnostic criteria to classify severity of internal carotid artery (ICA) stenosis vary across vascular laboratories. Consensus-based criteria, proposed by the Society of Radiologists in Ultrasound in 2003 (SRUCC), have been broadly implemented but have not been adequately validated. We conducted a multicentered, retrospective correlative imaging study of duplex ultrasound versus catheter angiography for evaluation of severity of ICA stenosis. Velocity data were abstracted from bilateral duplex studies performed between 1/1/2009 and 12/31/2015 and studies were interpreted using SRUCC. Percentage ICA stenosis was determined using North American Symptomatic Carotid Endarterectomy Trial (NASCET) methodology. Receiver operating characteristic analysis evaluated the performance of SRUCC parameters compared with angiography. Of 448 ICA sides (from 224 patients), 299 ICA sides (from 167 patients) were included. Agreement between duplex ultrasound and angiography was moderate (κ = 0.42), with overestimation of degree of stenosis for both moderate (50-69%) and severe (⩾ 70%) ICA lesions. The primary SRUCC parameter for ⩾ 50% ICA stenosis of peak-systolic velocity (PSV) of ⩾ 125 cm/sec did not meet prespecified thresholds for adequate sensitivity, specificity, and accuracy (sensitivity 97.8%, specificity 64.2%, accuracy 74.5%). Test performance was improved by raising the PSV threshold to ⩾ 180 cm/sec (sensitivity 93.3%, specificity 81.6%, accuracy 85.2%) or by adding the additional parameter of ICA/common carotid artery (CCA) PSV ratio ⩾ 2.0 (sensitivity 94.3%, specificity 84.3%, accuracy 87.4%). For ⩾ 70% ICA stenosis, analysis was limited by a low number of cases with angiographically severe disease. Interpretation of carotid duplex examinations using SRUCC resulted in significant overestimation of severity of ICA stenosis when compared with angiography; raising the PSV threshold for ⩾ 50% ICA stenosis to ⩾ 180 cm/sec as a single parameter or requiring the ICA/CCA PSV ratio ⩾ 2.0 in addition to PSV of ⩾ 125 cm/sec for laboratories using the SRUCC is recommended to improve the accuracy of carotid duplex examinations.

Project description:Randomized trials support carotid endarterectomy (CEA) in asymptomatic patients with ?60% internal carotid artery (ICA) stenosis. The widely referenced Society for Radiologists in Ultrasound Consensus Statement on carotid duplex ultrasound (CDUS) imaging indicates that an ICA peak systolic velocity (PSV) ?230 cm/s corresponds to a ?70% ICA stenosis, leading to the potential conclusion that asymptomatic patients with an ICA PSV ?230 cm/s would benefit from CEA. Our goal was to determine the natural history stroke risk of asymptomatic patients who might have undergone CEA based on consensus statement PSV of ?230 cm/s but instead were treated medically based on more conservative CDUS imaging criteria.All patients who underwent CDUS imaging at our institution during 2009 were retrospectively reviewed. The year 2009 was chosen to ensure extended follow-up. Asymptomatic patients were included if their ICA PSV was ?230 cm/s but less than what our laboratory considers a ?80% stenosis by CDUS imaging (PSV ?430 cm/s, end-diastolic velocity ?151 cm/s, or ICA/common carotid artery PSV ratio ?7.5). Study end points included freedom from transient ischemic attack (TIA), freedom from any stroke, freedom from carotid-etiology stroke, and freedom from revascularization.Criteria for review were met by 327 patients. Mean follow-up was 4.3 years, with 85% of patients having >3-year follow-up. Four unheralded strokes occurred during follow-up at <1, 17, 25, and 30 months that were potentially attributable to the index carotid artery. Ipsilateral TIA occurred in 17 patients. An additional 12 strokes occurred that appeared unrelated to ipsilateral carotid disease, including hemorrhagic events, contralateral, and cerebellar strokes. Revascularization was undertaken in 59 patients, 1 for stroke, 12 for TIA, and 46 for asymptomatic disease. Actuarial freedom from carotid-etiology stroke was 99.7%, 98.4%, and 98.4% at 1, 3, and 5 years, respectively. Freedom from TIA was 98%, 96%, and 95%, freedom from any stroke was 99%, 96%, and 93%, and freedom from revascularization was 95%, 86%, and 81% at 1, 3, and 5 years, respectively.Patients with intermediate asymptomatic carotid stenosis (ICA PSV 230-429 cm/s) do well with medical therapy when carefully monitored and intervened upon using conservative CDUS criteria. Furthermore, a substantial number of patients would undergo unnecessary CEA if consensus statement CDUS thresholds are used to recommend surgery. Current velocity threshold recommendations should be re-evaluated, with potentially important implications for upcoming clinical trials.

Project description:ObjectivePatients in the Carotid Revascularization Endarterectomy vs Stenting Trial (CREST) had duplex ultrasound (DU) scans prior to treatment and during follow-up to document the severity of carotid disease and the anatomic outcome of carotid endarterectomy (CEA) or carotid artery stenting (CAS). An ultrasound core laboratory (UCL) reviewed DU data from the clinical sites. This analysis was done to determine the agreement between site-reported and UCL-verified DU velocity measurements.MethodsClinical site DU worksheets, B-mode images, and Doppler velocity waveforms for the treated carotid arteries were reviewed at the UCL. The highest internal carotid artery peak systolic velocity (PSV) and associated Doppler angle were verified. If the angle was misaligned by >3 degrees, it was remeasured at the UCL and the PSV was recalculated. Agreement for PSV was defined as site-reported PSV within ± 5% of UCL-verified PSV. Transcription errors were corrected by the UCL but were not considered as disagreements. Follow-up analysis was limited to patients who received the assigned treatment.ResultsThe UCL reviewed 1702 prior-to-treatment and 1743 12-month follow-up DU scans (873 CEA, 870 CAS) from 111 clinical sites. Site-reported and UCL-verified PSV agreed in 1124 (66%) of the prior-to-treatment scans and 1200 (69%) of the follow-up scans. In those cases with a disagreement, Doppler angle accounted for disagreement in 339 (59%) of the prior-to-treatment scans and 277 (51%) of the follow-up scans. Based on a threshold PSV for ≥ 70% stenosis of ≥ 230 cm/s on the prior-to-treatment scans and ≥ 300 cm/s on the follow-up scans, UCL review resulted in reclassification of stenosis severity in 75 (4.4%) of the prior-to-treatment scans and 13 (0.75%) of the follow-up scans. There is evidence that the proportion of reclassification at follow-up was greater for CAS (10 scans; 1.2%) than for CEA (three scans; 0.34%) (P = .057).ConclusionsThere was a high rate of agreement between site-reported and UCL-verified DU results in CREST, and UCL review was associated with a low rate of stenosis reclassification. However, angle alignment errors were quite common and prompted recalculation of velocity in 20% of prior-to-treatment scans and 18% of follow-up scans. The use of a UCL provides a uniform process for DU interpretation and can identify sources of error and suggest technical improvements for future studies.

Project description:PurposeWe aimed to evaluate the long-term outcome of carotid endarterectomy (CEA) and carotid artery stenting (CAS) in patients who underwent both procedures on different sides.MethodsIn this single-center retrospective study (2001-2019), 117 patients (men, N = 78; median age at CEA, 64.4 [interquartile range {IQR}, 57.8-72.2] years; median age at CAS, 68.8 [IQR, 61.0-76.0] years) with ≥50% internal carotid artery stenosis who had CEA on one side and CAS on the other side were included. The risk of restenosis was estimated by treatment adjusted for patient and lesion characteristics.ResultsNeurological symptoms were significantly more common (41.9% vs 16.2%, P<0.001) and patients had a significantly shorter mean duration of smoking (30.2 [standard deviation {SD}, 22.2] years vs 31.8 [SD, 23.4] years, P<0.001), hypertension (10.1 [SD, 9.8] years vs 13.4 [SD, 9.1] years, P<0.001), hyperlipidemia (3.6 [SD, 6.6] years vs 5.0 [SD, 7.3] years, P = 0.001), and diabetes mellitus (3.9 [SD, 6.9] years vs 5.7 [SD, 8.9] years, P<0.001) before CEA compared to those before CAS. While the prevalence of heavily calcified stenoses on the operated side (25.6% vs 6.8%, P<0.001), the incidence of predominantly echogenic/echogenic plaques (53.0% vs 70.1%, P = 0.011) and suprabulbar lesions (1.7% vs 22.2%, P<0.001) on the stented side was significantly higher. Restenosis rates were 10.4% at 1 year, 22.3% at 5 years, and 33.7% at the end of the follow-up (at 11 years) for CEA, while these were 11.4%, 14.7%, and 17.2%, respectively, for CAS. Cox regression analysis revealed a significantly higher risk of restenosis (hazard ratio [HR], 1.80; 95% confidence interval [CI], 1.05-3.10; P = 0.030) for CEA compared to that for CAS. After adjusting for relevant confounding factors (smoking, hypertension, diabetes mellitus, calcification severity, plaque echogenicity, and lesion location), the estimate effect size materially did not change, although it did not remain statistically significant (HR, 1.85; 95% CI, 0.95-3.60; P = 0.070).ConclusionIntra-patient comparison of CEA and CAS in terms of restenosis tilts the balance toward CAS.

Dataset Information

Optimal cut-off criteria for duplex ultrasound for the diagnosis of restenosis in stented carotid arteries: review and protocol for a diagnostic study.

Background

Methods/design

Results

Discussion

Publications

Optimal cut-off criteria for duplex ultrasound for the diagnosis of restenosis in stented carotid arteries: review and protocol for a diagnostic study.

Similar Datasets

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