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Evaluation of tissue Doppler-based velocity and deformation imaging: a phantom study of ultrasound systems.
KTH, School of Technology and Health (STH), Medical Engineering, Medical Imaging.ORCID iD: 0000-0001-9419-910X
KTH, School of Technology and Health (STH), Medical Engineering.
KTH, School of Technology and Health (STH), Medical Engineering.
2011 (English)In: European Journal of Echocardiography, ISSN 1525-2167, E-ISSN 1532-2114, Vol. 12, no 6, 467-476 p.Article in journal (Refereed) Published
Abstract [en]

AIMS: The objective of this study was to test the accuracy and diagnostic interchangeability of tissue Doppler-based displacement, velocity, strain, and strain rate measurements in commercially used ultrasound (US) systems. METHODS AND RESULTS: Using an in-house made phantom, four different US scanner models were evaluated. Two different scanners of the same model were tested, and one scanner acquisition was tested twice with two generations of the same workstation giving six test results in total. The scanners were in active clinical use and are subject to regular maintenance checks. There were three displacement and four velocity results that stood out from the rest and could be regarded as accurate and interchangeable. Among the deformation measurements, three acceptable strain results were found while there were no acceptable strain rate results. Furthermore, the study showed that measurements from scanners of the same model, same acquisition post-processed on different workstations and repeated measurements from the same scanner, can yield disparate results. CONCLUSION: Measurements that are accurate and of interchangeable use can be found for displacement and velocity measurements, but are less likely to be found for strain and strain rate measurements. It is strongly recommended that the ability of each individual US scanner to measure displacement, velocity, strain, and strain rate is evaluated before it is introduced into clinical practice, and it must always be evaluated together with the workstation the scanner is intended to be used in conjunction with.

Place, publisher, year, edition, pages
OXFORD UNIV PRESS , 2011. Vol. 12, no 6, 467-476 p.
Keyword [en]
Ultrasound scanner; Tissue Doppler, Velocity imaging, Strain imaging, Phantom, Quality assurance
National Category
Medical Laboratory and Measurements Technologies Medical Equipment Engineering
Identifiers
URN: urn:nbn:se:kth:diva-34176DOI: 10.1093/ejechocard/jer056ISI: 000293527600012PubMedID: 21565867Scopus ID: 2-s2.0-80051995818OAI: oai:DiVA.org:kth-34176DiVA: diva2:419678
Note

QC 20110527

Available from: 2011-05-27 Created: 2011-05-27 Last updated: 2017-12-11Bibliographically approved
In thesis
1. Evaluation of Errors and Limitations in Ultrasound Imaging Systems
Open this publication in new window or tab >>Evaluation of Errors and Limitations in Ultrasound Imaging Systems
2011 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

There are binding regulations requiring safety and efficacy aspects of medical devices. The requirements ask for documentation that the devices are safe and effective for their intended use, i.e. if a device has a measuring function it must be correct. In addition to this there are demands for quality systems describing development, manufacturing, labelling, and manufacturing of a device. The requirements are established to guarantee that non-defective medical devices are used in the routine clinical practice. The fast rates in which the imaging modalities have evolved during the last decades have resulted in numerous new diagnostic tools, such as velocity and deformation imaging in ultrasound imaging. However, it seems as if the development of evaluation methods and test routines has not been able to keep up the same pace. Two of the studies in this thesis, Study I and IV, showed that computed tomography-based and ultrasound based volume measurements can yield very disparate measurements, and that tissue Doppler imaging-based ultrasound measurements can be unreliable.

Furthermore, the new ultrasound modalities impose higher demands on the ultrasound transducers. Transducers are known to be fragile, but defective transducers were less of a problem earlier when the ultrasound systems to a lesser extent were used for measurements. The two other studies, Study II and III, showed that serious transducer errors are very common, and that annual testing of the transducers is not sufficient to guarantee an error free function.

The studies in the thesis indicate that the system with Notified Bodies, in accordance with the EU’s Medical Device Directive, checking the function and manufacturing of medical devices does not work entirely satisfactory. They also show that the evaluation of new methods have led to the undesirable situation, where new measuring tools, such as volume rendering from imaging systems, and tissue Doppler-based velocity and deformation imaging in echocardiography are available for clinicians without proven knowledge about their accuracy.

Place, publisher, year, edition, pages
Stockholm: KTH Royal Institute of Technology, 2011. x, 74 p.
Series
Trita-STH : report, ISSN 1653-3836 ; 2011:3
National Category
Medical Laboratory and Measurements Technologies
Identifiers
urn:nbn:se:kth:diva-34177 (URN)978-91-7501-026-7 (ISBN)
Public defence
2011-06-10, Sal 3-221, Alfred Nobels Allé 10, Flemingsberg, 13:00 (Swedish)
Opponent
Supervisors
Note
QC 20110527Available from: 2011-05-27 Created: 2011-05-27 Last updated: 2011-05-30Bibliographically approved

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