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Diagnostic efficacy of SonoVue®, a second generation contrast agent, in the assessment of extracranial carotid or peripheral arteries using colour and spectral Doppler ultrasound: a multicentre study

¹ Department of Radiology, King's College Hospital, Denmark Hill, London SE5 9RS, UK, ² Department of Radiology, Edinburgh Royal Infirmary, Edinburgh, Lothian, UK, ³ CHU de Besancon, Service de Radiologie B, Boulevard Fleming, F-25030 Besancon, Belgium, ⁴ Department of Imaging, Royal Postgraduate Medical School, Hammersmith Hospitals Trust, Du Cane Road, London W12 OHS, UK, ⁵ Department of Surgery, Imperial College School of Science, Technology & Medicine, Charing Cross Hospital, Fulham Palace Road, London W6 8RP, UK, ⁶ Inselspital-Division of Angiology, Department of Internal Medicine, University of Berne, Freiburgstarsse 10, 3010 Berne, Switzerland, ⁷ Department of Surgery, Uppsala University Hospital, Akademiska sjukhuset, 75185 Uppsala, Sweden, ⁸ Schwerpunktpraxis für Angiologie, Wilsnacker Strae 14, 10559, Berlin, Germany, ⁹ Department of Vascular Surgery, Academic Medical Centre, Meibergdreef 9, NL-1105 AC DE Amsterdam, The Netherlands, ¹⁰ Servizio di Radiologia, Ospedale Valduce, Via Dante Alighieri, 11, 22100 Como, Italy, ¹¹ Bracco Diagnostics Inc., 107 College Road East Princeton, Princeton, NJ 08540, USA and ¹² Bracco Imaging SpA, Via E. Folli 50, 20134 Milan, Italy

The purpose of this study was to demonstrate the improvement in diagnostic quality and diagnostic accuracy of SonoVue® microbubble contrast-enhanced ultrasound (CE-US) versus unenhanced ultrasound imaging during the investigation of extracranial carotid or peripheral arteries. 82 patients with suspected extracranial carotid or peripheral arterial disease received four SonoVue doses (0.3 ml, 0.6 ml, 1.2 ml and 2.4 ml) with Doppler ultrasound performed before and following each dose. Diagnostic quality of the CE-US examinations was evaluated off-site for duration of clinically useful contrast enhancement, artefact effects and percentage of examinations converted from non-diagnostic to diagnostic. Accuracy, sensitivity and specificity were assessed as agreement of CE-US diagnosis evaluated by an independent panel of experts with reference standard modality. The median duration of clinically useful signal enhancement significantly increased with increasing SonoVue doses (p0.002). At the dose of 2.4 ml of SonoVue, diagnostic quality evaluated as number of inconclusive examinations significantly improved, falling from 40.7% at baseline down to 5.1%. Furthermore, SonoVue significantly (p<0.01) increased the accuracy, sensitivity and specificity of assessment of disease compared with baseline ultrasound. SonoVue increases the diagnostic quality of Doppler images and improves the accuracy of both spectral and colour Doppler examinations of extracranial carotid or peripheral arterial disease.

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