Enewscardio_july09 Lr

CARDIOVASCULAR 2009 No1

news THE ESAOTE MAGAZINE

Focus on:

Quantification and

The daily work and outcome of a Cardiovascular Lab goes through a stateof-the-art technology which must be capable of helping and supporting physicians (no matter what is their skill level), providing tools usable in all patient conditions and manageable with simple,

Prevention in Cardiovascular Ultrasound

effective interactions in order to always reach diagnostic confidence. The above concept is the strategic objective of Esaote Cardiovascular Ultrasound, a fundamental assumption in the development of such an important theme like Quantification and Prevention of CV Diseases.

Quantification 1. Ultrasound Transducers

The First Element of the Chain

The transducer is the primary component in the Signal Processing Chain that leads to the final ultrasound diagnostic image. Even though much effort has been made to optimize scan converters, post processing algorithms and sophisticated speckle reduction technologies, the first and the main interface between the patient and the user of the ultrasound scanner still remains the ultrasound transducer. The design of the material and the manufacturing technology of an ultrasound transducer is a fundamental determinant of the system image quality. The iQProbe represents state of the art Esaote Technology due to the innovation of Quality gold standard ultrasound transducers. Designed to improve performance and ergonomics, iQProbe Technology is based on the following project developments:

iQProbe Ergonomics

Active Matrix Composite Material

Multiple Adaptive Layers

Geometric Lens and Filling Material

The iQProbe Technology has applied to dimensions, size and weight design projects an extremely important special focus on the availability of light material and a revolutionary manufacturing scheme which avoids the use of a heavy anti-interference protection capsule. The combination of iQProbe technology and the appleprobe design represents a terrific improvement in innovation allowing the user optimal comfort while providing unparalleled clinical results and customer satisfaction.

Reduces the high electric impedance (consequent loss of the transmission power), minimizes the extremely high acoustic impedance of PZT material (20 times greater than human tissue) and improve the ultrasound wave propagation generated within the PZT material through the tissue.

The Multiple Adaptive Layers Technology reinforces the target achievement with a further improvement of sensitivity based on an extraordinary pure pulse signal and an extended bandwidth greater than 100%.

Microscopic view of the Active Matrix Composite Material

Microscopic view of the Multiple Adaptive Layers Technology

The iQProbe Technology is based on an extraordinarily low-absorption silicone-based material used in the Geometric Lens Manufacturing Process, thus obtaining a homogeneous high sensitivity within the whole bandwidth. The iQProbe Technology has introduced in the manufacturing process a Structure Filling Material with the objective to provide stronger stability of the array structure, maximising the highest level of decoupling between array elements. The silicone-based material used for the geometric lenses has extreme importance to the efficiency of the overall transducer sensitivity.

2. Imaging Process Algorithms Ultrasound suffers from an intrinsic imaging artefact called speckle. Speckle is the random grainy texture that obscures anatomy in ultrasound images and is usually described as “noise”, in order to indicate something that dirties the image. Speckle is created by a complex interference of ultrasound echoes made by reflectors spaced closer than the ultrasound system’s resolution limit, degrading spatial and contrast resolution and obscuring the underlying anatomy. The algorithm of processing the ultrasound signal to obtain extraordinary results in diagnostic confidence improvement is fundamental. It needs to perfectly combine the power of the technology with “easy to use” and “user configurable” settings; therefore, it must have a real time effect involving all available functions in the scanner from the probe to the screen.

A Deeper Look into XView Technology XView Technology is a real-time algorithm that provides a significant reduction in speckle. It achieves speckle reduction during each one of the stages that covers all the ultrasound image formation process. The algorithm function gives the user the option to choose between three different levels of image optimization in order to obtain the best

www.esaote.com

possible image depending on the application. In addition to the settings provided by the system, the operator can make use of the User Optimization “C” Setting, which operates on three parameters of the image: XSmooth, XDetail and XEnhancement. For each of these parameters it is possible to set the level within a certain range. By modifying these levels the

user will change the characteristics of the image displayed on the screen according to the following guideline:

in the information that constitutes the image, enabling the end user to view even the minimum characteristics and particulars.

> XSmooth regulation flattens the “noise” that affects the image.

> XEnhancement maximizes the information that enables the end user to visualize in the best possible way the information related to the structures already emphasized with the previous steps.

> XDetail enhances the details of the contours, curves, edges and structures present

news 3. Quantification in Echocardiography In the last twenty years the continuous progress of technology has helped the diffusion of this technique for diagnosis, staging and follow up of cardiac diseases. In many cases, the first diagnosis is based on the simple visualization of valvular lesions or of anatomical changes of cardiac structures. Then, in the quantification stage, the echocardiographic software offers the possibility of measuring diameters, thicknesses, areas, volumes and related indices as well as getting a flow quantification using color flow and spectral Doppler. All these parameters offer many cardiac function indices but in most cases there are only indirect, quantifying just the consequences of myocardial dysfunctions and cardiac defects. A first attempt of getting a direct quantification of the myocardial function has been made using modified Pulsed Wave Doppler to measure myocardial velocities. After

more than 20 years since its first publication, Doppler Myocardial Imaging is still called “new technology” and hasn’t entered yet the tool box of the great majority of cardiologists in spite of being relatively cheap and easy to use. This is because of its major limitation which is intrinsic of being a Doppler based quantification system, thus angle dependent. As a matter of fact, it is useful only to quantify the myocardial velocity on the basal segment of the ventricles. The advent of digitized echocardiography from this simple Doppler based quantification of myocardial velocity enabled the development of different TDI (Tissue Doppler Imaging) techniques. All of them have had a limited impact on clinical echocardiography, this once again due to angle, signal noise and measurement variability. When the angle between the velocity direction and the ultrasound beam is > 20°, the real velocity is underestimated. Since the ventricular

AHS - Aided Heart Segmentation

geometry doesn’t always allow a correct alignment, TDI derived measures will show a lower validity especially in a dilated heart, i.e. in all cases where we need a myocardial quantification. Recently, improvements in 2D echocardiographic image resolution have enabled the detection of tissue pixels and tracking of these acoustic markers from frame to frame. The tissue velocity is estimated from the local frame-to-frame displacement; the automatic evaluation of the velocity in a certain point is determined by comparing the displacement of the image data around that point in two consecutive frames. These methods have been used, in several different formulations, in many research fields and fall into the category known as Optical Flow, commonly referred to as Speckle Tracking in ultrasound imaging. These systems are totally angle independent. By tracking myocardial selected points during the cardiac cycle it is possible to get a precise quantification of

Prevention

displacement of myocardial structures over time and in any direction. The most commonly studied parameters are myocardial velocity, myocardial deformation (strain) and its velocity (strain rate). Esaote has developed a specifically designed tissue tracking software, called XStrainTM , to derive values for longitudinal, circumferential and radial velocities, Strain and Strain Rate. The processing system of this algorithm is based on a mono-dimensional technology and seems to be very accurate. In humans, reference values for children and adults have recently been published (Bussadori, Moreo et al. 2009)1. In this study, high applicability and repeatability of the measurements have been exhaustively demonstrated. The use of XStrainTM technology in human cardiology is getting wider and wider to assess congenital heart defects and many acquired myocardial diseases. This rapid and user friendly layout is now the most preferred software for evaluation of myocardial synchronicity in cardiac resynchronization therapy. The direct quantification of global and segmental myocardial systolic function in humans has been demonstrated to be more specific and sensitive in identification of early

stage systolic dysfunction. One of the major problems encountered by operators that begin using this kind of software is the learning curve and repeatability difficulty in point selection that may result in an unacceptable variability of the values, thereby repeating the same measurement in the same videoclip. In the latest version of XStrain TM Esaote introduced a new tool called AHS (Advanced Heart Segmentation). This system is based on standard ASE heart segmentation and has dedicated methods for apical and short axis views, along with help for the operator in point selection, maintaining the same proportion of segmental size regardless of the dimensions of the ventricle to be examined. This resulted in a dramatic reduction in time of processing and inter- and intra- operator variability. In a recent repeatability study, the intraoperator variability was of 4% among expert operators and of 7% among absolutely inexperienced operators, 7%. At this stage, XStrain TM software can satisfy all needs of an echocardiographist looking for a reliable, fast and easy tool for direct quantification of the ventricular function.

1. A new 2D-Based method for myocardial velocity, strain and strain rate quantification in a normal and paediatric population: assessment of reference value – CV Ultrasound 2009, 7:8 February 2009

The RF-data technology innovation as developed by Esaote makes it possible to measure automatically and accurately the positions of the anterior and posterior blood vessel wall, providing blood vessel wall diameter, change in diameter and blood vessel wall thickness of an artery as a continuous function of time. These measured basic blood vessel wall properties provide, by calculation, access to all major CVD related vascular stiffness parameters, e.g. pulse wave velocity.

Why RF-data technology?

Ultrasonic waves have an intimate and strong interaction with propagating media, only the radio frequency (RF) signal received preserves 100% of the informative content collected. A B-Mode ultrasound image is a non-linear grayscale representation of the RF signals received. The non-linear character of the B-mode image processing necessary for optimal image

quality makes the B-mode image unsuitable for measuring blood vessel wall properties. Therefore, by obtaining RF-data technology for the measurement of blood vessel wall properties Esaote uses 100% of the available information in the data received, solving the traditional compromise between image quality and measurement quality.

Assessment of Blood Vessel Wall Properties by means of Ultrasound Cardio Vascular Disease (CVD) is the most common cause of death in adults worldwide. CVD is not only a major threat to individuals and their “quality” and “durability” of life, but is also a major economic burden. Early detection and monitoring of progression can provide the opportunity for early medication therapy rather than surgery at a later and more critical phase. Early indications of CVD are: > Thickening of the blood vessel wall > Stiffening of the blood vessel wall > High blood pressure > High-level of cholesterol

Thickening of the blood vessel wall

Stiffening of the blood vessel wall

Clinical studies have shown that an increased vessel wall thickness (IMT) was associated with an increased risk of incident myocardial infarction. Therefore, IMT has been used as an important atherosclerosis surrogate in clinical practice and in many clinical studies.

Stiffening of the blood vessel wall is the result of a long, but steady process and is accelerated

Healthy vessel

Diseased vessel

Driving Pressure

by life style (food, smoking, lack of exercise and increased weight). In its final phase people are confronted with the disastrous consequences,

Blood vessel

Change in diameter (distension)

Health vessel response

Distension 8% of diameter

The progression of CVD will result in plaque formation with consequent reduction in blood flow possibly leading to cardiovascular problems including hearth failure, myocardial infarction and stroke. Heart failure can be the consequence of a diseased and stiff arterial tree, transferring too much load on the heart itself and yielding consequent remodeling of the ventricles. Myocardial infarction is usually related to myocardial ischemia because of reduced blood flow. Stroke is mostly caused by plaque rupture that

Driving Pressure

generates emboli reaching and blocking the cerebral circulation. CVD is the result of a long, but steady process and is accelerated by life style. In its final phase people are confronted with the disastrous consequences. Today no direct feedback can be provided to subjects about the quality of their vascular condition, with the consequence that no early treatment or early followup is initiated to prevent further degradation of the vascular condition and to delay the moment that the disease causes serious troubles.

e.g. high systolic blood pressure, myocardial infarction and stroke Blood vessel

Stiff vessel response

Change in diameter (distension)

Distension 4% of diameter

Plaque

www.esaote.com

Quantification and

The cardiology workflow management

in One Powerful Solution

Prevention in Cardiovascular Ultrasound

Image and data management for all cardiology modalities

RF

Estensa is a dedicated information system for the management of all Cardiologic Department activities: Interventional Cardiology, ElectroCardiography, EchoCardiography, Electrophysiology. Based on SmartClient technology, it merges the benefits of typical Client Server solutions with the simple distribution method of the Web based solutions. Unifying

all administrative and clinical procedures and exams in a single interface, Estensa becomes essential for data management, statistics, report creation, imaging and recording signal management, order entry and worklist distribution. The automatic realtime stock and inventory management, with barcode reader support, allows for a timely control of costs,

Plan & Execute

Report & Review

Archive & Record

Distribute

Enterprise-wide information systems to streamline clinical and administrative workflow

Professional Workstations for Cardiologic image visualization, elaboration & reporting

PACS & publishing systems for small, distributed & enterprise film-less hospitals

Image distribution over Intranet/Internet

expiration dates and disposables. Any procedure/exam can be documented and statistically analyzed for a complete scientific data extraction and cost-saving optimization. Thanks to DICOM 3.0, HL7 and FDA-XML standard communication protocols, Estensa connects to all modalities, supporting systems interoperability and avoiding data duplication.

QAS and RFQIMT Technologies

Quality Arterial Stiffness (RFQAS) and Quality Intima media Thickness (RFQIMT) are based on the Esaote RF-data technology for the accurate assessment of arterial stiffness and vessel wall thickness. They are the first step to early detection and early follow-up of CVD, preventing further degradation of the vascular condition and to delay the moment that the disease causes serious troubles. The RFQAS and RFQIMT measurements are taken at the Common Carotid Artery, which represents a critical point in the vascular system.

Assessment of arterial stiffness

Assessment of blood vessel thickness RF QIMT targets the measurement of the blood vessel wall thickness of a subject in a selected area of investigation. The ease of use combined with the real time quality feedback helps the operator to achieve accurate and reproducible

results. The measures (even taken at different examination times) can be reported on a normalised graph represented as plot indicators to assist physicians in their diagnostic and therapeutically procedures.

Healthy vessel Diameter: 5.93 mm IMT: 324 µm

Stiffness measurements

Diseased vessel Diameter: 6.61 mm IMT: 976 µm

For a properly carry out of the IMT measurement it is recommended to follow the Mannheim protocol which describes very clearly the procedure. The software of the system supports the Mannheim protocol in the measurement process and in the reporting structure. During the scanning of the carotid artery the doctor gets real-time feedback on measurement quality via quality indicators overlaid on the

RF QAS targets the measurement of the blood vessel stiffness of a subject in a selected area of investigation. The blood vessel wall stiffness is expressed as pulse wave velocity obtained from brachial blood pressure and the accurate measurements of diameter and change in diameter. Moreover, the local blood pressure at the site of the ultrasound measurement is given. Local blood pressure and stiffness is derived as quantification results based on sophisticated clinical studies.

ultrasound image at the position of the vessel wall (organge lines) and the far wall intima layer (green line). This real time feedback gives the doctor the possibility to optimize his probe position to have the best perpendicular position of the scan plane in respect to the far wall of the common carotid artery.

During the scanning of the carotid artery the doctor gets real-time feedback on measurement quality via quality indicators overlaid on the ultrasound image at the position of the vessel wall (orange lines) and an indication of distension (green lines). This real time feedback gives the doctor the possibility to optimize his probe position to have the best perpendicular position of the scan plane in respect to the far wall of the common carotid artery.

What is diameter? Diameter: 7.04 mm

Vessel parameters

Diameter: 7.04 mm Distension: 610 µm Stiffness PWV: 5.7 m/s

What is distension? Distension: 610 µm

Age: 24

Age: 45

D: 7.0 mm D: 605 µm PWV: 5.3 m/s

D: 7.5 mm D: 281 µm PWV: 8.1 m/s

QAS is not available for sales in the USA

For any other information please visit our site www.esaote.com www.esaote.com

Patient

D: 6.3 mm D: 124 µm PWV: 11.3 m/s

CARDIOVASCULAR 2009 No.1

Focus on:

Quantification and

Prevention in Cardiovascular Ultrasound

10.000 Portable

Ultrasound Installed Leader in Premium Performance

Committed to Education

Main events ACC 2009 - American College of Cardiology Orlando, FL - USA on 29/03/2009 - 31/03/2009 ASE 2009 - American Society of Echocardiography Washington, DC - USA on 06/06/2009 - 10/06/2009

International School

19th European Meeting on Hypertension Milan, Italy on 12/06/2009 - 16/06/2009 ESC 2009 - European Congress of Cardiology Barcelona, Spain on 29/08/2009 - 02/09/2009

Advanced

Cardiovascular Ultrasound

At ESC: Advanced RF-based Vascular Ultrasound Symposium Tuesday, September 1st, 2009 AHA 2009 - American Heart Association Orlando, FL - USA on 14/11/2009 - 18/11/2009 MEDICA 2009 Dusseldorf, Germany on 18/11/2009 - 21/11/2009 EUROECHO 2009 - 13th Annual meeting of European Association of Echocardiography Madrid, Spain on 09/12/2009 - 12/12/2009

www.esaote.com

International Activities: Via di Caciolle, 15 - 50127 Firenze, ITALY Tel. +39 055 4229 1 - Fax +39 055 4229 208 - E-mail: [email protected] Domestic Activities: Via A. Siffredi, 58 - 16153 Genova, ITALY Tel. +39 010 6547 1 - Fax +39 010 6547 275 - E-mail: [email protected] FRANCE Esaote France S.A.R.L. 22, rue Pierre Grange, 94124 Fontenay-sous-Bois Tel. +33 1 4871 2525, Fax +33 1 4871 3630 [email protected]

GERMANY Esaote Biomedica Deutschland GmbH Max-Planck-Straße 27a, 50858 Köln Tel. +49 221 9268 00 00, Fax +49 2234 9679 628 [email protected]

SPAIN Esaote España S.A. Avda San Sebastian, s/n 08960 Sant Just Desvern, Barcelona Tel. +34 93 473 2090, Fax +34 93 473 2042 [email protected]

THE NETHERLANDS AND BELGIUM Pie Medical Benelux B.V. P.O. Box 1132, 6201 BC Maastricht Tel. +31 43 3824650, Fax +31 43 3824651 [email protected]

UK Esaote Europe BV UK Branch Office, 400 Thames Valley Park Drive, Reading, Berkshire. RG6 1PT Tel. +44 118 965 3500, Fax +44 709 288 0231 [email protected]

BRASIL Brasilian Direct Office Rua Tomas Carvalhal, 711, 04006-001 São Paulo SP Tel. +55 11 2589 0533 Fax +55 11 2589 0527 [email protected]

ARGENTINA Esaote Latinoamérica S.A. San Martín 551, Cuerpo ‘C’, Piso 8, (C1004AAK) Buenos Aires Tel. +54 11 4326 1832, Fax: +54 11 4328 1245 [email protected]

INDIA Esaote Asia Pacific Diagnostic Private Limited F-1, Level 1, Global Arcade, Near Global Business Park M.G. Road, Gurgaon (Haryana)-122002 Tel. +91 124 4775600, Fax +91 124 4775699 [email protected]

CHINA Esaote China Ltd 18/F, 135 Bonham Strand Trade Centre, 135 Bonham Strand, Sheung Wan, Hong Kong Tel. +852 2545 8386, Fax +852 2543 3068 [email protected]

RUSSIAN FEDERATION AND CIS Esaote S.p.A. 18 Leningradsky prospekt, off. 5 and 6, Moscow 125040 Tel. +7 495 232 0205, Fax +7 495 232 1833 [email protected]

Specifications subject to change without notice

USA Biosound Esaote Inc. 8000 Castleway Drive, P.O. Box 50858, Indianapolis, IN 46250 Tel. +1 317 813 6000, Fax +1 317 813 6600 [email protected] 833 0904 000 (MA Rev. A)

Esaote S.p.A.