Professional Documents
Culture Documents
Purpose
Cardiac ultrasonic scanning systems are designed specifically for real-time,
noninvasive imaging of heart structures and functionality. They are used to
detect such conditions as mitral and aortic stenosis and insufficiency, to
determine the extent of damage from suspected myocardial infarction, and to
diagnose congenital cardiac defects, such as patent ductus arteriosus and
transposition of the great arteries. Cardiac ultrasound can also be used
instead of cardiac catheterization to monitor ventricular function.
Transesophageal echocardiography (TEE) is commonly used for detecting
myocardial ischemia and monitoring cardiac output. Intraoperative use of
TEE allows analysis of regional cardiac wall motion, in which abnormalities
have been shown to develop within 10 to 15 seconds of coronary occlusion.
Some cardiac systems are equipped with vascular capabilities. Vascular
ultrasonic scanning gives the physician profiles of arteries and veins
throughout the body and is used to diagnose atherosclerotic obstructions, occlusions, disease, and incompetence
by means of a two-dimensional (2-D), real-time image of the organ or vessel, as well as a profile of blood-flow
velocity through the area being examined. In many cases, vascular
ultrasonic scanning systems obviate the need for contrast
arteriography, which requires vessel cannulation, contrast media UMDNS Information
injection, and ionizing radiation exposure. Vascular ultrasound
imaging is the primary screening method for deep vein thrombosis This Product Comparison covers the following
device terms and product codes as listed in ECRI
(DVT) (Hedrick et al. 1995). Many ultrasonic scanning systems that Institute’s Universal Medical Device
are marketed primarily for cardiac applications can be used for Nomenclature System™ (UMDNS™):
Scanning Systems, Ultrasonic, Cardiac [17-422]
other applications; however, additional transducers or software Scanning Systems, Ultrasonic, Intravascular [17-746]
may need to be purchased.
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Tel +1 (610) 825-6000 Fax +1 (610) 834-1275 Web www.ecri.org E-mail hpcs@ecri.org
Scanning Systems, Ultrasonic, Cardiac; Intravascular
Intravascular ultrasonic (IVUS) scanning systems use a high-frequency miniature transducer mounted on the
tip of a catheter to produce 360° cross-sectional images of blood vessels for both diagnostic and therapeutic
applications, including identification of arterial plaque and vessel lesions, measurement of vessel dimensions and
stenosis, monitoring of balloon angioplasty and atherectomy procedures, and deployment of intravascular stents.
Principles of operation
Ultrasound waves are sound waves emitted at frequencies above the
range of human hearing. Ultrasound waves are mechanical (acoustic)
vibrations that require a medium for transmission; because they exhibit the
normal wave properties of reflection, refraction, and diffraction, they can
be predictably aimed, focused, and reflected.
A typical ultrasonic scanning system consists of a beamformer, a central
processing unit, a user interface (e.g., keyboard, control panel, trackball),
several probes (transducers or scanheads), one or more video displays,
some type of recording device, and a power system, usually mounted on a
cart.
To perform cardiac ultrasonic imaging, an ultrasonic probe is placed on
the skin after an acoustic coupling gel has been applied. Ultrasonic probes
contain one or more elements made of piezoelectric materials (materials
that convert electrical energy into acoustic energy and vice versa). When
the ultrasonic energy emitted from the probe is reflected from the tissue,
the transducer receives some of these reflections (echoes) and reconverts
them into electrical signals. These signals are processed to form images of
the tissue.
Various probes of different ultrasonic frequencies are available. For
diagnostic imaging, frequencies ranging from 2 to 30 megahertz (MHz) are
typically used; frequencies of 3 to 4 MHz are normally used for cardiac
scanning, frequencies of 5 to 15 MHz are considered optimal for vascular
scanning, and frequencies of 15 to 30 MHz are used for intravascular
scanning. Probes that generate higher frequencies produce shorter
wavelengths and narrower beams, improving resolution; however, higher-
frequency sound energy is more readily absorbed by tissue, and the usable
depth of penetration is decreased. Higher frequencies can be used for
improved resolution when deep penetration is not necessary (e.g., in
pediatric studies). Many systems now have broadband probes, which have
larger frequency ranges than traditional probes and offer combinations of
deeper penetration and higher resolution in the same probe.
Various modes are available for displaying the returning echoes. B-mode (brightness-modulated mode) is the
scanning system’s basic imaging mode. B-mode produces a real-time, 2-D image that represents a cross-sectional
slice of the area under study. The image is created as the transducer sweeps the pulsed ultrasound beam through
the image plane either electronically or mechanically. The image is updated multiple times to produce a live (real-
time) image, and the sweep (or frame) rate determines how often the image is updated. M-mode (motion mode)
uses a fixed-position pulsed beam to produce a moving display of a single scan line over an interval of time. Used
almost exclusively in cardiac applications, M-mode produces a graphical display of a moving structure (e.g., the
cardiac valve over several heartbeats). Simultaneous display of M- and B-mode images is particularly useful
when examining dynamic structures such as the heart.
Transducers used for 2-D cardiovascular examinations most commonly generate two differently shaped
Figure 1. Views of a variety of transducers: (1) flat linear, (2) curvilinear, and (3) phased .
patterns—rectangular (linear) images and wedge-shaped (sector) images. Intravascular transducers produce
radial, or ringlike, doughnut-shaped images. Linear images are produced by flat linear-array transducers, which
contain as many as 128 individual piezoelectric elements arranged in a single line, with available array lengths of
Figure 1. Views of a variety of transducers: (1) flat linear, (2) curvilinear, and (3) phased.
4 to 15 cm. The elements are pulsed sequentially in groups, advancing from one end of the array to the other
while the system switches between transmission and reception modes. This produces a number of parallel
acoustic beams across the length of the array during a single sweep to image a rectangular region directly in front
of the elements. (Figure 1 illustrates the basic types of transducers and the patterns they generate.) As with other
real-time scanners, each linear sweep updates the display with a new cross-sectional image. Various methods are
used to improve image resolution, such as special transmit-and-receive phase-delay techniques that significantly
improve beam focusing and image quality. Because the entire length of the array is placed on the patient’s skin, a
large field of view (FOV) displays structures close to the transducer. Therefore, the flat linear-array (often called
just linear array) system is ideal for vascular examinations in which the vessel might be positioned close to the
transducer—but these systems do have some disadvantages. For example, maintaining complete skin contact
with the large surface of the array is sometimes difficult. In addition, images of structures that lie beneath
obstructions such as bone or gas pockets are difficult to obtain with a linear-array transducer.
Current sector scanning uses array transducers, which consist of a series of linear piezoelectric elements.
Curvilinear-array (convex-array) probes operate similarly to flat linear-array probes, but their convex shape
allows a larger field of view with the same contact area so that images of deep structures can be more easily
obtained.
Electronically steered scanning uses phased-array transducers, which consist of a series of individual
piezoelectric elements operating as a unit. Phased arrays are the same as linear arrays, except that they have
smaller contact areas and electronic timing circuits that allow them to fire groups of elements in a variety of
sequences. This permits each burst of ultrasonic energy to leave the transducer at a slightly different angle.
Transmitting and receiving ultrasonic energy at different angles within the scan plane forms a sector image.
Phased-array transducers are generally smaller and easier to handle than most transducers. However, they
require more sophisticated electronic timing systems. Although they provide a limited FOV for nearby structures,
their smaller scanning surfaces (often as small as 6 mm) permit imaging of structures in tight areas or behind
obstructions (e.g., areas between or behind ribs). Most cardiac ultrasonic systems produce sector images using
transducers with small scanning surfaces. Some systems combine linear- and phased-array techniques to provide
a trapezoidal (often termed “vector”) imaging format. This is accomplished by adding pie-shaped sectors to both
sides of a rectangular linear image. The transducer’s scanning surface is slightly larger than that of a normal
phased-array transducer, and the sector image that is produced has a wider FOV in the near field.
Unlike earlier mechanically steered transducers, electronic transducers provide a greater number of imaging
capabilities, such as simultaneous 2-D and Doppler imaging. And, because they have no moving parts, they also
appear to be more reliable. But in the typical linear-element configuration, with rows of elements arranged
horizontally, electronic focusing is possible only in the 2-D (horizontal) scan plane; therefore, there is no focusing
action along the transducer’s vertical plane to reduce slice thickness.
Multidimensional arrays have the normal row of elements arranged horizontally, but they also have a few (five
to seven) vertical rows of elements. These vertical rows allow the arrays to be focused in the vertical (slice
thickness) plane as well, creating a tighter focal area. However, the vertical focus cannot always be adjusted, nor
can the beams be steered vertically. Nevertheless, these arrays, often referred to as 1.5-dimensional arrays,
provide somewhat better vertical resolution than standard linear arrays.
Each sweep produces a new cross-sectional image (frame) that is used to update the display. Generally, high
frame rates are useful for imaging rapidly moving structures, while lower frame rates provide improved image
quality by increasing the density of the acoustic lines that make up the image. Depending on the system, frame
rates can be fixed, selected by the operator, or varied automatically based on the field of view chosen by the
operator. Some scanning systems permit the user to change the field of view by varying the sector angle.
A scan converter system displays the image on a high-resolution video monitor. During scanning, the
converter assigns discrete shades of gray (grayscale) to the returning echo amplitude levels; the number of shades
depends on how many bits of information can be stored for each point of image memory. Some scanners offer
user-selectable pre- and postprocessing features that permit the operator to optimize the image quality by altering
the texture and grayscale emphasis within the image. The scan converter also permits freeze-frame, which
captures a single real-time frame for display, recording, and analysis. Cine mode (cine loop) allows real-time
playback of several seconds of recently displayed frames as either a continuous loop or a variable-speed, static,
frame-by-frame review.
Some systems allow the operator to magnify (zoom) the display for further examination and can also save
images to hard disks or magneto-optical disks or transfer them via networks for storage on picture archiving and
communication systems (PACS) (see the Product Comparison titled Information Systems, Information and Image
Management, Cardiology for more information).
Many ultrasonic scanning systems suppliers make their systems compliant with the American College of
Radiology/National Electrical Manufacturers Association Digital Imaging and Communications in Medicine
(DICOM) 3.0 Standard. The purpose of this standard is to allow digital images produced by any medical device to
be stored and transferred through PACS or other means regardless of device supplier.
The maximum display depth of a system indicates the depth for which space is provided on the display rather
than actual penetration by the ultrasound energy, which is based on many factors, including transducer and
signal-processing characteristics. The display depth and the size or field of view of the displayed image are
usually operator selectable.
Scanned structures can be accurately measured using digital calipers—cursors electronically superimposed
over the scanned cross-sectional image that calculate the size of the scanned structure. The calipers can also be
used to plot and measure the area, circumference, or volume of a structure.
A keyboard is used to enter and select information for display, such as patient name, date, and type of study,
with the scanned image. Data-entry keyboards can be used with a computer on some systems to permit
manipulation of the displayed image.
Doppler imaging
Cardiovascular scanners use Doppler imaging to determine the direction and speed of blood flow. Most
scanners include spectral Doppler, either continuous wave (CW) or pulsed wave (PW). CW Doppler, the simplest
spectral Doppler mode, is commonly used for blood-flow analysis where vessel depth information is not
important; it receives information from all the moving reflectors in the path of the beam. CW Doppler can
provide accurate blood velocity through the sample area. PW Doppler is used when depth selectivity is required,
but its use is limited when detecting higher velocities because of the problem of aliasing; when the pulse-
repetition frequency (PRF) is too low to adequately sample the Doppler frequency shift, frequency aliasing causes
high-velocity blood flow in one direction to be displayed as flow in the opposite direction. To resolve the problem
of frequency aliasing, the PRF can be increased or a lower-frequency transducer can be used. Some scanners allow
the use of a high pulse-repetition frequency (HPRF) Doppler mode—a function that corrects for aliasing by
increasing the PRF for a sample volume depth. PW Doppler allows the operator to select the area of interest for
flow analysis using cursors superimposed on the 2-D image. PW depth-selective information is obtained by
acoustic pulses emitted from the transducer, allowing the precise location of the target area, as well as the flow, to
be determined.
Spectral Doppler includes a spectrum analyzer to display frequency shifts plotted against time, with grayscale
intensity varying with the received signal’s strength or amplitude. The spectrum analyzer may also employ fast
Fourier transform (FFT), a high-rate sampling method that analyzes the Doppler-shift signals and performs
complex calculations on them. FFT analyzers typically produce peak and mean displays. The peak display
provides a linear-time waveform that represents the maximum instantaneous velocity present. The mean display
provides a linear-time waveform that represents the statistical mean velocity of all velocities present.
Commercially available spectrum analyzers incorporate various permutations of these displays, but the basic
peak and mean should be adequate for most clinical applications.
Some units provide a simultaneous display of real-time and 2-D and Doppler imaging. Other units freeze the
2-D image when Doppler is engaged; if the transducer or patient moves, however, it can be difficult to determine
the precise anatomic location of the blood flow being measured. Thus, some units update the 2-D image at
adjustable intervals, although the Doppler shuts off during the 2-D update. True simultaneous (duplex) scanners
allow the 2-D image to remain in real time (although at a lower frame rate) while the Doppler beam provides flow
information.
Doppler color-flow mapping (CFM) simultaneously assesses the direction and relative velocity of blood flow at
multiple points along multiple beam paths. The result is an image of the hemodynamics of the heart and vessels.
As conventional 2-D real-time techniques display the anatomic features in black and white, color superimposed
on this image visually depicts the direction and velocity of blood flow. CFM complements and enhances the
diagnostic value of conventional 2-D real-time images, as well as provides more information about and enables
better quantification of the direction and average velocity of blood-flow abnormalities.
Like color television, CFM uses combinations of primary colors. Typically, in cardiac and other vascular
studies, red and blue hues are commonly used. White shades are often added to the colored background to
indicate higher flows, such as those caused by stenotic valves or narrowed vessels. In addition to blood-flow
direction, mean flow rate and degree of variance can also be depicted by CFM.
Many scanning systems are capable of power Doppler imaging, which can be used as an adjunct to CFM.
Power Doppler displays the integrated power of the reflected signal in the conventional color-flow Doppler
technique. It increases the flow sensitivity of color Doppler imaging and provides good results even at angles
perpendicular to the direction of flow, which cannot be visualized at all with standard Doppler. This technology
can produce images of structures not normally seen sonographically. However, power Doppler provides no
quantitative data, such as flow rate or direction.
Some systems offer a triplex mode, which simultaneously acquires and displays 2-D grayscale, spectral
Doppler, and color-flow data. Triplex mode is used in the quantification of blood flow and flow anomalies in
small vessels to improve placement of the Doppler sample volume.
Contrast agents
The use of contrast agents has recently been very successful, especially in diagnostic evaluations of cardiac
structures and function. Ultrasonic contrast agents are foreign substances (e.g., microbubbles, emulsions, colloidal
suspensions) that have acoustic properties that alter ultrasonic echoes produced by blood or tissue. Placed in the
bloodstream, they can improve the effectiveness of the scan by enhancing blood echogenicity or increasing the
reflectivity between normal and abnormal tissue. Clinical applications of contrast agents include determining the
extent of valvular stenosis or regurgitation and performing both stress echocardiograms to diagnose coronary
disease and myocardial perfusion studies. Contrast enhancement as a simple adjunct to Doppler examination also
shows promise as a less invasive method to allow rapid and more accurate assessment of the severity of left and
right flow abnormalities. TEE is also used with contrast agents to measure blood flow in the heart. Contrast
echocardiography has become an important, cost-effective adjunct to noninvasive diagnosis and evaluation of
cardiac anatomy and physiology. Ultrasound technologies such as harmonic imaging (HI) improve visualization
of contrast agents.
Catheter insertion requires a sheath for introduction and 0.035 to 0.0635 cm (0.014 to 0.025 in) guide wires (also
called imaging cores). After the catheter is positioned, a full 360° cross-sectional image from inside the vessel can
be obtained to view plaque deposits or vessel obstructions. Since a mechanical transducer can be moved within
the sheath while it is rotating, catheters are particularly well suited for pullback and longitudinal 2-D display to
assess the distribution of plaque. These 2-D axial images can be reconstructed in three dimensions using special
postprocessing software. This technique provides important diagnostic information about peripheral and
coronary vessel disease that may not be obtainable through angiography or angioscopy.
Some suppliers of intravascular scanners offer intraoperative probes configured either as catheter-based
transducers or as miniaturized transducers for use on the fingertip or between two fingers. Applications include
epicardial scanning for rapid image acquisition before, during, and after cardiac bypass surgery; imaging
coronary artery circulation; and assessing mitral valve reconstructive surgery. Research is focused on using
intraoperative epicardial scanning (with Doppler and CFM) to improve surgical management of cardiac
disorders. Imaging with catheter-based transducers has potential applications in electrophysiology and cardiac
catheterization procedures.
Data analysis
Most cardiac ultrasound data analysis systems include software for B-mode, M-mode, Doppler, and stress-
echo (exercise testing) studies. Other software programs can measure important anatomic regions of the heart and
calculate physiologic parameters such as ejection fraction, cardiac output, stroke volume, and heart valve areas
using measurements that indicate the shape and size of the heart’s features as seen from a particular angle; other
algorithms then determine whether the computed values are within a normal range. A step-by-step instructional
format or menu clearly defines the sequence of commands or codes needed to perform a certain type of analysis.
Although no 2-D image can represent the actual shape of the heart and provide measurements of its overall
dimensions for analysis, parameter values derived from ultrasound data analysis systems correspond well to
those obtained by invasive procedures (e.g., cardiac catheterization).
Software packages for stress-echo testing analyze wall motion of the left ventricle before and during exercise to
detect any abnormalities in muscle contraction that might indicate an area of ischemia caused by coronary artery
occlusion. These abnormal regions are commonly described by their type or degree of muscle movement (e.g.,
normal, akinetic, dyskinetic). An image of the chamber outline in diastole is superimposed over an image in
systole, and the combined image is divided to make wall-motion measurements of the ventricle before and after
contraction. Plotting these measurements against a group of normal contraction values allows the operator to
identify areas of abnormal wall motion, which can be related to the level of ischemia in the muscle. Wall-motion
analysis can also be used to monitor infarcted tissue areas in patients recovering from acute myocardial
infarctions.
The Doppler software package can be used to measure blood flow and flow abnormalities. From an outline of a
Doppler color image of blood backflow into the left atrium, special formulas calculate regurgitant jet area and
determine the severity of mitral regurgitation. Other algorithms reveal evidence of valvular stenosis by searching
for an increase in the velocity of blood flowing through the channels of valves. By analyzing the echo frequency
spectra of the blood flow from precise points inside the heart chambers, certain analytical programs can
distinguish between benign and pathological heart murmurs and identify their points of origin. Some vascular
analysis packages can make calculations automatically.
Some software is flexible enough to allow reprogramming to meet the needs of the individual patient—for
example, redesigning a stress-echo review program to accommodate a patient’s physical and medical condition.
Moreover, because the microprocessors used in many of these systems are not dedicated for use with any one
type of cardiac analysis software, they run any software that can normally be used with the computer.
Hard-copy reports generally include several pages with patient information across the top, calculated
functions in the middle, and a summary of findings, recommendations, and/or a preliminary diagnosis at the
bottom. Other pages in the report can contain chamber-wall analysis diagrams, time/wall-motion graphs, and
charts that plot patient versus normal values for cardiac parameters.
The use of echocardiography requires prompt interpretation to affect patient management; it is now possible to
transmit digitized images over telephone lines and the Internet. Software and hardware are available to transmit
images over standard telephone lines so that a cardiologist in a remote location can interpret images obtained in
an emergency room or other facility. Some ultrasound data analysis systems can be connected to a local area
network—for example, a network of ultrasound scanners, other workstations, and storage devices.
Reported problems
Concerns have been raised about the safety of transmitting ultrasound energy through the human body.
Although there are demonstrated biological effects—tissue heating, cavitations, and potential cell mutations—
associated with ultrasound energy, none of them have been proven to affect patients to a harmful degree.
Nevertheless, it is important to understand these effects. For more information on the biological effects of
ultrasound, see the April 1999 Health Devices article cited in the bibliography.
However, like other ultrasound diagnostic techniques, echocardiography and vascular scanning appear to be
risk-free when used properly. But its accuracy depends on the skill of the operator, who must continuously and
carefully adjust transducer direction and instrument controls to avoid artifacts in ultrasound images, which can
significantly degrade image quality and possibly lead to an incomplete or incorrect diagnosis. Therefore, cardiac
and vascular scanning should be performed only by specially trained technologists. In addition to routine quality-
assurance procedures, the scanner must be maintained in accordance with its manufacturer’s technical support
service.
Ultrasound transducers should be handled carefully to avoid damage. A quality control program should
include frequent testing of transducers and system performance with standard ultrasound phantoms to evaluate
lateral and axial resolution, distance and Doppler accuracy, sensitivity, uniformity, and hard-copy appearance.
Electromechanical problems such as cracks in piezoelectric elements can alter beam width and/or the spatial pulse
length, thereby affecting lateral and axial resolution. Errors in distance measurements can cause incorrect
calculations. An error margin of 2% or less measured over 10 cm is considered acceptable for most ultrasound
systems. The hard-copy image should look the same as the image on the monitor. Most manufacturers can supply
a test pattern on software to evaluate the performance of the recording device.
Purchase considerations
ECRI Institute recommendations
Included in the accompanying comparison charts are ECRI Institute’s recommendations for minimum
performance requirements for cardiac and intravascular ultrasound scanners; recommended specifications have
been categorized into three groups based on specific clinical applications.
Cardiac ultrasonography, or echocardiography, involves assessing the structure and function of the heart and
great vessels. This includes imaging the cardiac valves, heart chambers, wall motion, and thickness. Cardiac
ultrasound can utilize the full range of a scanner’s Doppler capabilities. During echocardiography, flow and
turbulence can be examined throughout the heart and great vessels. Cardiac analysis packages calculate
quantitative 2-D and Doppler values to aid diagnosis. Electrocardiography is normally incorporated for timing
reference. Some units perform stress echocardiography studies. A comprehensive cardiac study requires a full-
featured system, which is typically used in a hospital’s cardiology department or a private cardiology office. A
portable system could be transported from the cardiology department to the bedside, intensive care unit (ICU),
coronary care unit, or catheterization lab or to an off-site clinic. Examinations include comprehensive adult or
pediatric echocardiography. Most cardiac procedures use phased-array probes at frequencies between 2 and 7.5
MHz. Also, cardiac systems should offer at least one TEE probe type that operates at these same frequencies.
A cardiac scanner equipped with vascular sonographic capabilities provides the clinician with flow profiles of
vessels throughout the body to allow diagnosis of arterial and venous abnormalities and their causes. Doppler
further extends vascular techniques by providing flow detection in vessels, such as those found in organs and
tumors and in extremities. Spectral Doppler analysis packages can make calculations automatically. A
comprehensive vascular study requires a full-featured system, which is used in a hospital’s radiology
department, cardiology department, or vascular lab or in a vascular surgeon’s office. Although the majority of
comprehensive vascular studies are performed within the lab of the responsible hospital department, the
department’s personnel perform many routine studies at the patient’s bedside or in the ICU or emergency
department. Examinations include comprehensive extracranial and peripheral vascular studies. Most vascular
studies utilize linear-array probes that operate at frequencies between 5 and 10 MHz.
Intravascular ultrasound is an adjunct to angiography and angioplasty. It uses the same ultrasound imaging
technology described for cardiac and vascular ultrasound. However, the transducer is mounted at the end of a
catheter that is introduced into an artery. In addition to imaging, these catheters can measure the velocity of blood
flow within an artery, which is useful for determining the severity of blockage and shows the composition of the
underlying atherosclerotic plaque. This information can be invaluable in determining which of the many types of
angioplasty procedures would be best to treat the blockage.
Other considerations
When purchasing an ultrasonic scanning system, facilities need to consider six basic issues: scanner functions
and features, cost, ease of use, upgradability, image storage, and customer support. For state-of-the-art cardiac
ultrasound applications, the following features should be incorporated in the system:
Digital scan converter with a display matrix size of at least 512 x 512 pixels, 6 bits deep (64 shades
of gray)
PW and CW Doppler
Adjustable depth-gain control
Pre- and postprocessing selections or presets specific to cardiac examinations
CFM
Cine mode covering several seconds, as well as freeze-frame capability
Electrocardiogram (ECG)-triggered cardiac measurements
TEE scanning capability with multiplane TEE transducers
Frame rates of at least 50 fps
A useful range of probes
A typical configuration for a cardiac ultrasound system consists of a scanner and software, several single- or
multifrequency transducers, a TEE probe, color Doppler, M-mode, CFM, cardiac analysis software, a VCR, and a
black-and-white or color printer. Pediatric TEE procedures usually require smaller specialty TEE probes, and
intraoperative TEE procedures can require probes with longer cables to facilitate access to the area of interest
while avoiding interference with surgical procedures and/or anesthesia delivery. Some systems may have
optional vascular, abdominal, and/or intraoperative scanning capabilities. Other options include additional
probes (e.g., endocavity), analysis packages (e.g., vascular, urology, obstetrics/gynecology [OB/GYN]), and
image-archiving devices. Purchasers should consider buying a system that is DICOM 3.0 compatible or
upgradable to DICOM 3.0 conformance because networking ultrasonic scanning systems and computer
workstations can make image storage and retrieval, as well as ultrasound department management, more
efficient.
In addition, facilities should ask suppliers if their scanners can perform advanced contrast agent imaging or
can be inexpensively upgraded to perform these procedures.
Ultrasound accreditation
Within the last several years, the American College of Radiology, the American Institute of Ultrasound in
Medicine, the Intersocietal Commission for the Accreditation of Vascular Laboratories, and the Intersocietal
Commission for the Accreditation of Echocardiography Laboratories have introduced accreditation programs for
hospital- and office-based ultrasound practices. These voluntary accreditation programs were created to ensure
the quality of ultrasound imaging because significant variations in the quality of imaging have been found among
hospitals and offices. Healthcare payers and managed care providers could insist on ultrasound accreditation as a
condition for being a referral site or for reimbursement.
Cost containment
Because ultrasound systems entail ongoing maintenance and operational costs, the initial acquisition cost does
not accurately reflect the total cost of ownership. In today’s competitive ultrasound market, there are, in general,
few significant technical differences among high-end ultrasonic scanning systems manufactured by market
leaders. Therefore, a purchase decision should be based on issues such as life-cycle cost (LCC), local service
support, discount rates and non-price-related benefits offered by the supplier, and standardization with existing
equipment in the department or hospital (i.e., purchasing all ultrasonic scanning systems from one supplier).
An LCC analysis can be used to compare alternatives and/or to determine the positive or negative economic
value of a single alternative. For example, hospitals can use LCC analysis techniques to examine the cost-
effectiveness of leasing or renting equipment versus purchasing the equipment outright. Because it examines the
cash-flow impact of initial acquisition costs and operating costs over a period of time, LCC analysis is most useful
for comparing alternatives with different cash flows and for revealing the total costs of equipment ownership.
One LCC technique—present value (PV) analysis—is especially useful because it accounts for inflation and for the
time value of money (i.e., money received today is worth more than money received at a later date). Conducting a
PV/LCC analysis often demonstrates that the cost of ownership includes more than just the initial acquisition cost
and that a small increase in initial acquisition cost may produce significant savings in long-term operating costs.
The PV is calculated using the annual cash outflow, the dollar discount factor (the cost of capital), and the lifetime
of the equipment (in years) in a mathematical equation.
The following represents a sample seven-year PV/LCC analysis for a cardiac/vascular ultrasound system.
Other costs not included in the above analysis that should be considered for budgetary planning include those
associated with the following:
Software upgrades not covered by the service contract
Fulfillment of accreditation program requirements
Optional specialty probes
Optional image-archiving or data analysis system
Utilities
Other disposables and accessories, such as biopsy needles, contrast agents, phantoms, and
procedure trays
Contributions to overhead
As illustrated by the above sample PV/LCC analysis, the initial acquisition cost is only a fraction of the total
cost of operation over seven years. Therefore, before making a purchase decision based solely on the acquisition
cost of an ultrasound system, buyers should consider operating costs over the lifetime of the equipment. For
further information on PV/LCC analysis, customized analyses, and purchase decision support, readers should
contact ECRI Institute’s SELECTplus™ Group.
Hospitals can purchase service contracts or service on a time-and-materials basis from the supplier. Service
may also be available from a third-party organization. The decision to purchase a service contract should be
carefully considered. Because ultrasound systems tend to be highly reliable (many suppliers have a 99% to 100%
uptime guarantee), the financial risk associated with not purchasing a service contract may be minimal. However,
the decision to purchase a service contract can be justified for several reasons. Most suppliers provide routine
software updates, which enhance the scanner’s performance, at no charge to service contract customers.
Furthermore, software updates are often cumulative; that is, previous software revisions may be required in
order to install and operate a new performance feature. Purchasing a service contract also ensures that preventive
maintenance will be performed at regular intervals, thereby eliminating the possibility of unexpected
maintenance costs. Also, many suppliers do not extend system performance and uptime guarantees beyond the
length of the warranty unless the system is covered by a service contract. Because transducers and hard-copy
imaging devices are the components of the system most prone to failure or damage, the service contract should
cover probes and hard-copy imaging devices.
ECRI Institute recommends that, to maximize bargaining leverage, hospitals negotiate pricing for service
contracts before the system is purchased. As a guideline, a full-service contract typically costs approximately 8%
of the ultrasound system’s purchase price. Additional service-contract discounts may be negotiable for multiple-
year agreements or for service contracts that are bundled with contracts on other scanners in the department or
hospital. Buyers should also negotiate for a nonobsolescence clause stating that the supplier agrees not to
introduce a replacement system within the next one or two years and that if a replacement system is introduced
during this time period, 100% or some prorated percentage of the purchase price can be applied to the purchase
of the new system.
In addition, given the current highly competitive market for ultrasound, hospitals should negotiate for a
significant discount—some suppliers may discount up to 15% or 25%. The actual discount received will depend
on the hospital’s negotiating skills, the system configuration and model to be purchased, previous experience
with the supplier, and the extent of concessions granted by the supplier, such as extended warranties, fixed prices
for annual service contracts, and guaranteed on-site service response. Buyers should make sure that applications
training is included in the purchase price of the system. Some suppliers do offer more extensive on- or off-site
training programs at an additional cost.
ECRI Institute recommends that buyers consider the number and types of ultrasound studies to be performed
before deciding on a specific system configuration. Also, if multiple scanners are necessary to handle the patient
volume, hospitals should consider the types of scanners and capabilities that need to be purchased to avoid
paying for unnecessary analysis packages and scanning features. For instance, a hospital may want to purchase
three scanners: one dedicated to OB/GYN procedures, one dedicated to general radiology, and one dedicated to
cardiac scanning. In this case, purchasing all three scanners from one supplier could result in a significant
discount. Standardization of equipment can make staff training easier, simplify servicing and parts acquisition,
and provide greater bargaining leverage when negotiating the purchase of new equipment and/or service-
contract costs.
In the last few years, the technology has been evolving and manufacturers have begun introducing portable
ultrasound scanners that are smaller, more sophisticated, easier to use, and less expensive than their
predecessors. Traditionally, portable ultrasound units were purchased and used mainly for situations in which
using a full-sized model was impractical or too expensive because they lacked the advanced features required for
some applications. Although there are currently no portable scanners on the market that are equipped to serve as
a hospital’s only scanner, there are portable units capable of specific applications that rival the capabilities of
conventional full-sized units. The purchase of a portable ultrasonic scanner for applications that previously
would have been handled using a larger, more expensive full-sized scanner may result in considerable savings
for the hospital. When investigating the feasibility of such an approach, facilities should ensure that the models
under consideration offer the capabilities and features they need and provide images of sufficient quality to allow
diagnosis.
Given their relatively low capital cost compared to other imaging equipment, ultrasonic scanning systems are
typically purchased outright; however, leasing for more expensive, high-performance systems is becoming more
common. In general, renting is not a cost-effective alternative.
Stage of development
Cardiac scanning systems have been available since the early 1980s, and intravascular scanners were
introduced commercially in 1990. Trends are moving toward the use of digital processors to provide image
enhancement, improved resolution, analysis of tissue characteristics, and more sophisticated transducer scanning
techniques. This introduction follows the larger trend toward the development of all-digital imaging
departments.
Given ultrasonic imaging’s low cost relative to other imaging technologies (approximately $250,000 for a
typical cardiovascular scanning configuration), its noninvasiveness, the absence of ionizing radiation, and recent
improvements in image quality, ultrasound is one of the fastest-growing imaging techniques. Expanding vascular
applications include guided sclerotherapy; assessment of pelvic venous congestion, saphenous insufficiency,
saphenofemoral reflux, and perforator disease; and imaging of the lower-extremity DVT. Continuing research is
focused on new transducers, three-dimensional (3-D) ultrasound, intraoperative ultrasound (the use of
ultrasound imaging to aid in surgery), ultrasound tissue characterization, and ultrasonic contrast agents.
Technologies for 3-D ultrasound, which involves volume-per-second acquisition and display, are available
from a few manufacturers for volume measurements, improved image presentation, and volume-of-interest
studies. 3-D images can be produced by direct online 3-D acquisition, with a transducer scanning a volume
instead of a slice of the tissue. However, most 3-D ultrasound methods use reconstruction of previously acquired
2-D cross-sections or tomograms in an off-line procedure. An advantage of 3-D ultrasound is that it can simulate
intraoperative visualization. Ultrasound images in 3-D may be clinically useful for cardiac, ophthalmic, brain,
prostate, renal, and fetal imaging. In intravascular ultrasound, however, the problems of uneven pullback speeds
and negotiating curved vessels represent important practical limitations that make this technology very difficult
to implement in a clinical setting.
Color Doppler imaging of myocardial tissue to show motion and assess myocardial viability is being
researched for applications in stress echocardiography, evaluations of heart abnormalities (e.g., Wolff-Parkinson-
White syndrome), and reperfusion therapy. This method allows velocity, acceleration, and energy maps of the
Doppler signal to be displayed. Color Doppler ultrasound is also being investigated as a means to determine
whether tumors and lesions are malignant or benign based on the presence—or lack—of blood.
One important aspect of intravascular ultrasound that is continuing to develop and improve is the imaging
guide wire. While some types of guide wires are now available, none fit the description of a true ultrasound
imaging guide wire, which would possess imaging capability, allow for navigation through the vascular system,
and serve as a guide for therapeutic catheters to find their way to the stenotic blood vessel and would not expose
any rotating parts to the vessel wall. The device would consist of a stationary outer housing with a rotating
imaging core inside. This design demands further miniaturization of the flexible driveshaft and the ultrasound
transducer. The main problems with developing these devices come from maintaining image quality, which
requires further research on ultrasound transducers to enhance sensitivity and lateral resolution.
Another technology in intravascular ultrasound that is still in the early stages of development is known as
elastography, or sonoelasticity. This technique has the potential to show the local hardness of vessel walls and
plaques, which would aid in the selection of the appropriate interventional treatment of atherosclerotic luminal
narrowing. The main principle underlying ultrasound elasticity imaging is that the response of a tissue to
mechanical excitation is a function of its mechanical properties. Although elastograms have been obtained
experimentally, the development of this technology for clinical use requires the ability to deal with specific
circumstances that can occur in vivo, such as motion artifacts and eccentric positioning of the catheter.
Some suppliers can now provide remote diagnostics that monitor device performance from remote locations to
diagnose problems before they become apparent to the user.
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Supplier information
Chart A: Cardiac/Vascular Ultrasonic Scanning Systems
ALOKA
Aloka Co Ltd [139280]
6-22-1 Mure Mitaka-shi
Tokyo 181-8622
Japan
Phone: 81 (4) 22456465 Fax: 81 (4) 22454058
Internet: http://www.aloka.co.jp
E-mail: int-sle2@am.aloka.co.jp
ESAOTE
Biosound Esaote Inc An Esaote Group Co [104220]
8000 Castleway Dr PO Box 50858
Indianapolis, IN 46250
Phone: (317) 813-6000, (800) 428-4374 Fax: (317) 813-6600
Internet: http://www.biosound.com
E-mail: info@biosound.com
Spain
Phone: 34 (93) 4732090 Fax: 34 (93) 4732042
Internet: http://www.esaote.com
E-mail: esaote.spain@bcn.servicom.es
FUKUDA DENSHI
Fukuda Denshi Co Ltd [138380]
3-39-4 Hongo Bunkyo-ku
Tokyo 113
Japan
Phone: 81 (3) 56841251 Fax: 81 (3) 38141222
Internet: http://www.fukuda.co.jp
E-mail: info@fukuda.co.jp
GE HEALTHCARE
GE Healthcare USA [439946]
3000 N Grandview Blvd
Waukesha, WI 53188
Phone: (262) 544-3011, (800) 643-6439 Fax: (262) 544-3384
Internet: http://www.gehealthcare.com
HITACHI
Hitachi Medical Corp [138226]
1-2-10 Uchikanda Chiyoda-ku
Tokyo 101
Japan
Phone: 81 (3) 32943851 Fax: 81 (3) 32943860
Internet: http://www.hatachi-medical.co.jp
KONTRON MEDICAL
Kontron Medical (Asia) [393103]
2 Clementi Loop #04-01 Moreton Logistics Center
Singapore 129809
Republic of Singapore
Phone: 65 4668542 Fax: 65 4668987
Internet: http://www.kontronmedical.com
E-mail: crystlin@singnet.com.sg
MEDISON
Medison America Inc [155965]
11075 Knott Ave Suite C
Cypress, CA 90630
Phone: (714) 889-3000, (800) 829-7666 Fax: (714) 889-3030
Internet: http://www.medisonusa.com
E-mail: info@medisonusa.com
PHILIPS MEDICAL
Philips Medical Systems Asia [188101]
30/Fl Hopewell Centre 17 Kennedy Road
Wanchai
People's Republic of China
Phone: 852 28215888 Fax: 852 25276727
Internet: http://www.medical.philips.com
E-mail: medical@philips.com
SIEMENS
Siemens AG Siemens Health Services [401832]
Hartmannstrasse 16
Erlangen D-91052
Germany
Phone: 49 (9131) 840 Fax: 49 (9131) 842379
Internet: http://www.siemensmedical.com
E-mail: info@siemens.com
Siemens SA de CV [339105]
Poniente 116 No 590
Cd de Mexico 02300
Mexico
Phone: 52 (5) 3282000 Fax: 52 (5) 3282017
Internet: http://www.siemens.de
TOSHIBA
Toshiba America Medical Systems Inc [101894]
2441 Michelle Dr
Tustin, CA 92780
Phone: (714) 730-5000, (800) 621-1968 Fax: (714) 734-0362
Internet: http://www.medical.toshiba.com
E-mail: info@tams.com
England
Phone: 44 (1727) 831666 Fax: 44 (1727) 865862
Internet: http://www.bsci.com
GE HEALTHCARE
GE Healthcare USA [439946]
3000 N Grandview Blvd
Waukesha, WI 53188
Phone: (262) 544-3011, (800) 643-6439 Fax: (262) 544-3384
Internet: http://www.gehealthcare.com
VOLCANO
Volcano Corp (Belgium) [440157]
Excelsiorlaan 41
Zeventem B-1930
Belgium
Phone: 32 (2) 6791076 Fax: 46 (2) 6791072
Internet: http://www.volcanocorp.com
E-mail: info@volcanocorp.com
Note: The data in the charts derive from suppliers’ specifications and have not been verified through
independent testing by ECRI Institute or any other agency. Because test methods vary, different products’
specifications are not always comparable. Moreover, products and specifications are subject to frequent changes.
ECRI Institute is not responsible for the quality or validity of the information presented or for any adverse
consequences of acting on such information.
When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect supplier
discounts. And although we try to indicate which features and characteristics are standard and which are not,
some may be optional, at additional cost.
For those models whose prices were supplied to us in currencies other than U.S. dollars, we have also listed the
conversion to U.S. dollars to facilitate comparison among models. However, keep in mind that exchange rates change
often.
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