Small Box for Big Problems

Compact ultrasound at a price?

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GE Healthcare's Logiq Book XP (GE Healthcare)

Sonosite's Scanpak (Sonosite Inc.)

The shrinking phenomenon that took a boombox and turned it into an iPod has finally infiltrated the medical imaging community. Long gone are the 400-pound refrigerator-sized ultrasound scanners. Today, sleek, affordable, compact ultrasound scanners are all the rage. And don't worry about missing out on some of the latest features – just because it's smaller doesn't mean these new portables skip the bells and whistles. The latest generation features pulsed wave (PW) Doppler, directional color power Doppler, even tissue harmonic imaging.

Compact ultrasound's portability and affordability have made point-of-care scanning ultrasound examinations available to nearly all medical professionals. "It used to be years ago that the only people using ultrasound were basically radiologists, cardiologists and obstetricians," says Lennard D. Greenbaum, MD, co-director of the Hughes Center for Fetal Diagnostics in Orlando. "Emergency medicine physicians, breast surgeons, endocrinologists, nephrologists, neurologists and anesthesiologists are now utilizing ultrasound equipment."

According to the American Institute for Ultrasound in Medicine (AIUM), the worldwide sales for ultrasound cashed in at $160 million in 2003 – a number they predict will inflate to $1 billion by 2010, half of which will comprise devices used to aid the physical examination. "We'll get to the day, sooner than any of us realize, when a physician will take a small ultrasound device out of his black bag," says Greenbaum.

However, this ubiquitous access may come at a cost. As a result of compact ultrasound's popularity, many obstacles have emerged that can compromise diagnostic quality. The technical limitations of the machine, the experience and training of the operator and the establishment of guidelines for procedures must be considered as the utilization of this new technology increases among nontraditional users. Ultimately, the welfare of the patient must always come first regardless of the ultrasound examination in any specialty or equipment size.

Space-Aged Stethoscope

Compact ultrasound is easily managed in areas where space and time are limited. Unstable patients in the intensive care unit (ICU) or emergency room (ER) and those who need an extension of the physical examination stand to benefit most. "[The compact device] and the information it provides are immediately available and the exam is performed in a way that's focused on the questions the clinician wants to ask," says Anthony DeMaria, MD, co-director of the University of California San Diego (UCSD) Cardiovascular Center and editor-in-chief for the Journal of the American College of Cardiology.

For example, ER physicians use the devices for abdominal aortic aneurysm screening, free fluid detection in the peritoneum in blunt trauma patients and some OB/GYN-related emergencies.

Ultrasound's effective, non-invasive ability to diagnose subsurface anomalies and internal structural abnormalities, along with its comparatively low cost, has quickly turned it into a powerful diagnostic tool for a horde of non-radiology specialties. "It's human nature to pick up the machine and start experimenting and looking inside the body," says Laurence Needleman, MD, associate professor in the department of radiology and co-director of the Non-Invasive Vascular Laboratory at Thomas Jefferson University Hospital in Philadelphia. "If you can answer a question or think you can answer it by looking inside, you're going to try."

Nuts and Bolts

According to a report provided by the Society of Radiologists in Ultrasound (SRU), summarizing their ultrasound conference held in 2003, the sales growth of compact systems in the United States is estimated at 25 percent to 30 percent per year, with the majority of sales coming from five medical specialties: cardiology (21 percent), radiology (16 percent), vascular (15 percent), obstetrics and gynecology (13 percent) and emergency medicine (12 percent).

Cardiology is currently the leading specialty using handheld ultrasound, and studies continue to illustrate the tool's value. Reports in the September issue of Chest, along with other recent studies, show that a brief ultrasound exam by cardiologists can increase diagnostic accuracy by nearly 40 percent. An earlier study released in Chest in 2003 maintains that handheld echocardiography (HHE) allows the evaluation of left ventricular function and the identification of pericardial or pleural effusion in ventilated patients – identifying problems that may not show up in the physical exam.

"They are good at looking at cardiac function overall," says Director of Cardiology at St. Louis University School of Medicine Arthur Labovitz, MD. He adds that other uses include evaluating the cardiac valves to look for valvular heart disease, determining if a valve either leaks or is obstructing flow and providing a cursory screening of great vessels like the aorta and pulmonary artery.

While limitations exist, "the trade off is all relative," Labovitz says. "If someone has a 10-year-old echo machine in their office that was [manufactured] before harmonic imaging, some of these handheld devices are superior to those old pieces of equipment." However, it is important to realize that a quick, focused examination with a handheld ultrasound device doesn't take the place of a complete, high-resolution examination.

Al Lojewski, global marketing manager for cardiac ultrasound for GE Healthcare, Waukesha, Wis., says there were 20 million echocardiography exams performed this year and the number has since grown at 8 percent. GE has gone through great efforts to assist in the management of these exams. Recently introduced, the Vivid i is a high-performance, portable cardiovascular ultrasound system. Compact products like the Vivid i and Logiq Book are full featured ultrasound systems that provide clinicians with a portable, competent tool. "Ultimately, the benefit for ultrasound in this miniaturization gives us our first step toward our overall mission for the stethoscope of the future," says Lojewski.

However, because the larger-sized compact systems have a $70,000 to $100,000 price range, widespread use will not occur as quickly as the handheld units, which cash in as low as $14,000.

While some of these higher end "laptop size" ultrasounds may encompass comparable capabilities as the conventional ultrasound, many of the handheld ultrasounds used to perform echocardiograms have limitations. "The [smaller] point-of-care devices don't have all the bells and whistles, don't have all the buttons and knobs and controls that the state-of-the-art devices do," says cardiologist John H. Alexander, MD, MS, FACC, assistant professor in the division of cardiology at Duke University Medical Center, Chapel Hill, N.C. "In a lot of ways, they are geared toward asking one focused question rather than performing a complete examination."

There is little argument among the experts that these compact ultrasounds are restricted to certain exams. "If you need to figure out if there is a heartbeat in a baby or not, that's a pretty 'yes or no' kind of answer. If you need to know if the baby has a subtle congenital anomaly, that's several more degrees of difficulty and a diagnosis best determined by traditional machines," says Needleman. "The simpler the question, the more compact ultrasound will have an impact." And the easier the patient is to image, the greater the chance compact ultrasound will be able to answer the question, he adds.

Two Sides to Every Problem

While the capability of the machine tends to be an initial concern, followed by the imaging difficulty of the patient (such as complicated anatomy or a larger physique), a third factor is the scanner examiner/operator and/or the interpreter. "An ultrasound is extremely operator dependent, and the widespread use of this unit has a potential for increased misdiagnosis due to poorly trained or inappropriate operators," says Melissa A. Vickery, LPN-B, RVT, president-elect, Society for Vascular Ultrasound.

Like any technology that has traveled from the hands of relatively experienced people to a broader population, there are two possibilities: Either the people using the machines will obtain the proper training education or more operators will perform the examination with inadequate education and clinical training.

There is a potential for an increase in medical errors as less qualified operators use this tool. "You run the risk of both false positives and false negatives, both of which have implications," says Alexander. "People who are doing the scanning and the people who are interpreting the studies [with compact ultrasound] often don't have as much experience as those who are doing the studies using the state-of-the-art devices."

The American Heart Journal published a study – Limited Echo Assessment Project (LEAP) – conducted by Alexander examining the training and accuracy of non-cardiologists in the simple use of point-of-care echo: Medical residents without specific training in echocardiography were put through a brief three-hour training course and then sent out to do echocardiograms. The accuracy of the residents' diagnoses was only slightly below that of a standard echocardiogram when looking for easier anomalies: pericardial effusion, left ventricular (LV) ejection fraction or how well the heart muscle pumps. However, they were substantially worse than the standard echocardiography when looking for valvular heart disease.

The field of diagnostic medical sonography is moving toward a required formalized educational program. "It is hard to imagine that a short-term course is capable of providing the depth of knowledge required to accurately perform an ultrasound examination when more and more sonographers are graduates of associates or bachelor degree programs in diagnostic ultrasound," says Laurinda S. Andrist, BS, RDMS, RDCS, president of the Society of Diagnostic Medical Sonography (SDMS). The SDMS will be hosting a consensus conference in the first half of 2005, which will be dedicated to establishing a common minimum curriculum for diagnostic medical sonographers.

Alexander says the results can be interpreted as the glass being half empty or half full. While a simpler diagnosis by a novice user is comparable to the standard echocardiogram, complicated diagnoses are far from dependable. Though Alexander acknowledges the limitations of the compact, he attributes the primary cause for this margin of error to experience and training. "Our gestalt has to do with who's doing the studies," he says. "There are more or less experienced people in everything." Creating a floor for the level of training and competency that's required of point-of-care echo operators may add water to the glass.

While the study confirmed that compact ultrasound should not replace standard echocardiography machines, it also illustrated the need for a set of practicing standards that incorporates guidelines and training.

Agreeing to Agree

Last April, the AIUM sponsored a compact ultrasound conference bringing together a panel of more than 20 organizations representing nine different medical specialties to discuss issues surrounding the emergence and use of compact ultrasound. "It was a groundbreaking event, as a variety of multi-specialty groups and representatives from ultrasound manufacturers met together to address similar concerns and begin to define the guidelines for the use of portable ultrasound units," says Vickery.

According to Greenbaum, the AIUM, the American College of Radiology (ACR) and the American College of Obstetricians and Gynecologists (ACOG) have already approved some guidelines for performing examinations. However, the American Medical Association (AMA) agrees that subspecialties should determine their own standards and guidelines. While the AIUM oversees the practice of ultrasound across many specialty lines in medicine, a physician can still follow the recommendation of their particular specialty group. "And in that situation," says Needleman, "many of the specialty groups' recommendations for training have not been as rigorous as the AIUM's."
"We need to work with all of the specialties that are using ultrasound to develop training that is specific for the uses their specialty chooses to embrace," says Greenbaum.

The American College of Cardiology and the American Society of Echocardiography (ASE) have published what they feel are minimum training criteria in order to interpret cardio studies with the compact device. They include, at the very least, interpretation with supervision of 300 echo studies, including 150 that have been performed by that individual. "Those are the numbers that have been found to achieve a level of independent reading." says Labovitz. "Anything short of that, we feel individuals would not have been adequately trained and may miss important diagnoses."

Ultrasound manufacturers have also been conscientious of debated guidelines when developing training programs for their products. "We've worked closely with the related associations to develop standards for the proper use of echocardiography by clinicians," says Lojewski. "We mostly refer back to those standards that have been outlined by groups like the ASE, AIUM or the SDMS."

But these organizations can't force physicians to take their responsibility to the modality and the patient seriously. "The issue of training is one that falls to the individual who performs the study or makes the diagnosis," says Labovitz. "Unless there is some threat – be that malpractice or the inability to get reimbursed – I think that, unfortunately, some people will take the path of least resistance."

Size Limits

Several years ago, some insurance carriers attempted to put a weight limit on ultrasound units they would reimburse. "If the machine can produce adequate images to allow you to document all of the elements of that exam, then it doesn't make a difference if it weighs 7 pounds or 400 pounds," says Greenbaum.

The AMA supported the decision that reimbursement should apply to the examination performed, not the type of equipment used. Carriers that originally raised that issue have since rescinded that policy, although there are common areas of interest regarding the increased use of compact ultrasounds.

"It was felt by the group attending the AIUM forum last April that reimbursement for compact ultrasound exams should be treated like any other ultrasound exam," says Vickery. However, new codes need to be developed in accordance with the new applications and examination guidelines related to the compact ultrasound, she adds.

Currently, compact ultrasound users must follow the same procedure to qualify for reimbursement as those using traditional ultrasounds. "You're going to need hard copies so somebody can see it, you need a report so people can refer to it and you have to follow protocols and guidelines for both performance and interpretation," says Needleman. Guidelines established for traditional ultrasounds that ensure quality, documentation and physician interpretation must continue to be met. According to Needleman, documentation and archiving are not always performed with compact ultrasounds.

If you're lost in this gray area of reimbursement, it only gets more complicated, continues Needleman. One of the trickier questions, he says, is whether compact ultrasound should be treated as an extension of the physical exam, like a stethoscope. This may not require the user to obtain the standard level of training and/or execute a complete ultrasound examination – compromising the set guidelines for reimbursement. Would this allow people to get away with doing less? This is one of many questions still being debated.

It's All About Quality

A new technology cannot be discussed without addressing territory. DeMaria has a very practical position. "Every physician learns how to use an ophthalmoscope and learns how to do a funduscopic examination as part of the physical examination, and the ophthalmologists don't seem to mind," he says.

Although concern exists, many imaging specialists are not threatened by the evolution and expansion of compact ultrasounds. The number of ultrasounds performed only increases every year. Greater concern lies in the competency of the user.

Beneath the politics and the business of healthcare, which can sometimes cloud medical issues, is a shared view that the patient comes first. Organizations will continue to come together to discuss and resolve issues that arise with the proliferation of compact ultrasound.

"I'll just keep on looking from the point of view of the patients and make sure they get the high quality that they deserve," says Needleman. "Rather than define it as a turf war, I'll define it as a quality war."

— Janine Kusza is a New Jersey-based freelancer. Questions and comments can be directed to editorial@rt-image.com.