Author + information
- Received August 3, 2016
- Revision received February 21, 2017
- Accepted February 23, 2017
- Published online March 5, 2018.
- Roland Richard Macharzina, MDa,∗ (, )
- Sascha Kocher, MDa,
- Steven R. Messé, MDb,
- Thomas Rutkowski, MDa,
- Fabian Hoffmann, MDa,
- Matthias Vogt, MDa,
- Werner Vach, PhDc,
- Nian Fan, MSca,
- Aljoscha Rastan, MDa,
- Franz-Josef Neumann, MDa and
- Thomas Zeller, MDa
- aDepartment of Cardiology and Angiology II, University Heart Center of Freiburg–Bad Krozingen, Bad Krozingen, Germany
- bDepartment of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania
- cCenter for Medical Biometry and Medical Informatics, University of Freiburg, Freiburg, Germany
- ↵∗Address for correspondence:
Dr. Roland Richard Macharzina, University Heart Center of Freiburg–Bad Krozingen, Suedring 15, D-79189 Bad Krozingen, Germany.
Objectives The purpose was to analyze the agreement and binary accuracy of the degree of internal carotid artery stenosis (ICAS) as determined by 4-dimensionally (4D) real-time gray-scale guided 3-dimensional (3D) color-Doppler ultrasonography (3DC-US) (4D/3DC-US) compared with catheter angiography (CA) and duplex ultrasonography (DUS). This study hypothesized that 4D/3DC-US is noninferior to CA and DUS in grading ICAS in selected patients.
Background Clinical stratification in patients with ICAS largely depends on a patient’s symptomatic status and the degree of stenosis.
Methods Screening with 4D/3DC-US was prospectively performed in 93 study patients (with 122 ICASs), thus yielding 80 patients for analysis (with 103 ICASs) after excluding patients with insufficient image quality, previous revascularization, and contraindications to CA. The ultrasound examination (10 MHz) consisted of consensus conform DUS examination and independent real-time 4D-guided gray-scale views for orientation followed by static 3DC-US NASCET (North American Symptomatic Carotid Endarterectomy Trial) percent stenosis quantification using off-line multiplanar rendering. Multiplanar selective CA of the same ICASs was quantified with dedicated software in a blinded fashion.
Results Quantitative CA of 103 stenoses with a mean degree of 65 ± 17% was compared with 4D/3DC-US, with a resulting concordance correlation coefficient of 0.89 and a standard deviation of differences (SDD) of 8.1% at a bias of +1.7%. Binary 50% and 70% stenosis detection with 4D/3DC-US revealed a sensitivity of 97% and 87%, respectively, and a specificity of 92% and 84%, respectively. Interobserver SDD for CA of 52 stenoses (7.2%) did not differ from SDD for 4D/3DC-US and CA (p = 0.274). Accuracy of 50% stenosis detection by 4D/3DC-US was tendentially higher compared with DUS (96% vs. 91%).
Conclusions The 4D/3DC-US method provides reliable and accurate stenosis quantification and binary classification with good diagnostic accuracy compared with CA and DUS.
- carotid artery stenosis
- catheter angiography
- 4-dimensional ultrasonography
- 3-dimensional ultrasonography
Dr. Messé has received research support from GlaxoSmithKline and Bayer; and is on the Clinical Events Committee of the SALUS trial sponsored by Direct Flow Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 3, 2016.
- Revision received February 21, 2017.
- Accepted February 23, 2017.
- 2018 American College of Cardiology Foundation
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