Ultrasound: making waves where it has never gone before
July 06, 2015
by Gus Iversen
, Editor in Chief
A few years ago, performing advanced medical imaging in a remote Moroccan village with no hospitals and no running water would have been virtually inconceivable. Over the last several years, however, a trend toward increasingly portable ultrasound systems has begun to change that.
As ultrasound extends its reach into rural parts of the planet, it is also seeing increased usage within the confines of the most modern hospitals. “The handheld ultrasound will become one of the most important tools that doctors will be carrying in their pocket,” says Dr. Jagat Narula, professor of medicine at Icahn School of Medicine at Mount Sinai. He believes it’s only a matter of time before the modality sends the stethoscope into permanent retirement.
The unprecedented portability of handheld ultrasound, combined with the safety of the imaging (which uses no ionizing radiation or toxic contrast agents), the diagnostic value of the pictures, and the relative low cost of the exam, all help explain why reimbursement has been kinder to ultrasound in recent years than it’s been to MR and CT.
Meanwhile, premium ultrasound systems have evolved in their own right. What they lack in portability they make up for with revolutionary diagnostic value and groundbreaking therapeutic utility beyond the capabilities of their handheld counterparts. All of this adds up to an industry worth over $6 billion globally and rising.
Starting from scratch in remote African villages
Approximately 800 women die every day from preventable complications associated with pregnancy and childbirth — and 99 percent of those deaths occur in developing countries. That’s why Asa Nordgren co-founded Trice Imaging Inc., a company that designed a DICOM-compliant medical image-routing platform to bring potentially life-saving diagnostics to the populations that most sorely lacked them.
When the project was first being developed in 2009, Nordgren says the concept of “connected health” was little more than “a bunch of PowerPoint presentations.” She and her team wanted to prove that modern technology could actually make ultrasound available in areas without physicians.
“We ultimately chose Morocco together with Qualcomm (which funded the project) because it’s a beautiful and fascinating country, but it’s also underserved when it comes to health care,” she says, adding that a rudimentary grasp of the French language goes a long way in communicating with the locals. Her team built everything from scratch. “I basically had a physician’s phone number and that was it,” says Nordgren. Over the course of four weeks they drove a mobile ultrasound caravan to three different rural villages; Oulmes, Boulmane, and Ribat el Kheir, and worked in local “health houses” to assist midwives, nurses, and doctors, in conducting ultrasounds using SonoSite MTurbo systems.
“One village had a health house that didn’t even have doors and windows, they had electricity that would go on and off and they had no running water,” says Nordgren. Using smartphones and tablets donated by Sony, they encrypted and transferred the images via a 3G network to consumer tablets, where physicians reviewed them and sent back diagnoses within 24 hours. Out of 575 women imaged, they discovered
94 high-risk pregnancies and were able to take appropriate measures to ensure those women received medical care when it was time to give birth. The other 481 expecting mothers were cleared to give birth in the customary fashion of the culture.
Goodbye stethoscope, hello PUPEDs?
Ultrasound has not always had the luxury of mobility. “When it started, the systems were quite large, like a refrigerator,” says Mount Sinai’s Narula. Patients had to be brought to a lab much the way they would for an MR or a CT scan. The growth of handheld ultrasound has allowed the procedure to take on a more fundamental role in patient evaluation. Incorporating handheld ultrasound into general examinations could reduce the overall cost of imaging care while also providing better outcomes and improving doctor-patient relationships, says Narula. “It is one of the most important ways of bringing medicine to the bedside, being able to get an accurate diagnosis, avoiding unnecessary imaging studies, and ensuring that what we identify is worthy of further investigation.”
Narula points out that the Greek origin of stethoscope can be translated as, “look inside the chest,” – and he believes it’s time to update the medical dictionary. “Ideally the ultrasound should be called stethoscope and the stethoscope should be called stethophone or something like that,” he says.
Philips Healthcare has initiated a consortium of health care leaders to drive the creation and implementation of mobile ultrasound solutions, and it counts Narula among the inaugural members. “One of the things we’re working on is credentialing for these handheld systems,” says Vitor Rocha, CEO of Philips Ultrasound. “How do you extend the use of these systems while ensuring high-level care?”
Narula says he has seen firsthand the ease with which student doctors can adapt to handheld ultrasound, “This is the generation of Playstation and they know how to handle gadgets.” On the other hand, he says, it’s the art of using a stethoscope that is being lost. “I don’t think the people from the Western countries have any talent left in terms of identifying the heart sounds and murmurs the way we used to do in the previous years,” says Narula. “We used to get significant one-on-one training with stethoscopes but that doesn’t happen anymore and our students today are incompetent at making diagnoses with it.” Instead he says they’re more likely to suggest imaging exams.
“Teaching someone to do ultrasound is not that tricky, I’ve become pretty good at it myself,” says Nordgren with a laugh. “It’s reviewing them and reading them, and making the diagnosis – that’s where the scarcity comes in.” Rocha and Narula both stressed that in a primary care setting, ultrasound would be intended for conducting a better initial examination – not replacing ultrasound as a specialty imaging modality.
Narula calls his ultrasound-as-stethoscope a “portable ultrasound as a physical examination device (PUPED)” and believes the cost of the imaging should be included in the exam itself. Medical students would be trained on the PUPEDs the same way they were once trained with stethoscopes, says Narula. He breaks down the schooling as follows: First year students would learn what normal looks like, in their second year they would contrast that vision of normal with examples of what is abnormal. By the third and fourth year they would start using PUPEDs for algorithms where, “If I look at these five things I can make a diagnosis in 95 percent of cases right at the bedside without requiring a full-fledged imaging exam,” says Narula.
For the remaining five percent, more advanced imaging may be called for. “The echocardiography laboratories are afraid this will decrease the number of scans going to them – which it will,” says Narula, “but only the unnecessary ones.”
Premium systems: A different ballgame
While handheld ultrasound may take the spotlight, premium ultrasound systems are ensuring better outcomes for the most complex patients. These high-end systems also continue to hold the largest share of the market, according to Jon Brubaker, an industry analyst from MD Buyline. Most of the quotes he sees pertain to the premium systems. “Cost-wise they are multiple times more expensive than hand-held systems,” says Brubaker, adding that the price can sometimes reach upward of $300,000. Cardiology and radiology accounted for over 25 percent of the overall ultrasound market in 2014, making them the largest individual segments.
Carestream, a leader in digital X-ray, announced at RSNA 2014 that it was going to delve into the ultrasound market. The company’s first two Touch Ultrasound systems received FDA approval this June. Its entry into the market is unusual, according to Brubaker, because where most newcomers target the lower-end segment, these are decidedly high-end offerings.
“Carestream is an innovator,” says Andrew Hartmann, the company’s general manager of global X-ray solutions, by way of explanation. “Innovation is cutting-edge, and cutting-edge is typically at the high end of imaging performance.” Premium ultrasound systems – a segment dominated by companies such as Philips, GE, Siemens, Acuson, Terason, and Toshiba – provide better quality images than their handheld counterparts. They are also more useful to unique departments within the hospital, having specialized transducers that make them capable of highly specific configurations.
Fusion imaging, the merging of ultrasound with MRI or CT images, is a sophisticated tool gaining ground in the operating room. Meanwhile elastography, for soft tissue evaluation, may even bring the value of ultrasound to lung imaging – an area where it had previously been of little use due to the modality’s inability to penetrate air. Rocha with Philips says premium ultrasound is also beginning to show promise as a treatment tool, and cites dissolving blood clots as one example.
Carestream plans to unveil lower-level versions of its ultrasound over time, all of which will feature exchangeable transducers that tell the system what kind of study is being conducted, a standardized user interface, and a physician log-in to access functionality preferences and implement them automatically. “If you can have a platform that’s completely scalable from ultra-premium down to point-of-care — we know that works for our customers,” says Hartmann.
What is revolutionary is hard to accept
For Rocha, the relationship between handheld ultrasound and premium ultrasound is comparable to the relationship between smart phones and supercomputers. The question of which is more powerful may depend on how one measures productivity. Nodgren’s Trice Imaging is currently doing a project in rural Texas connecting 20 ambulances to hospitals via handheld ultrasound.
“It has to do with getting the patient info to the right health care facility, having the right staff ready when the patient arrives, and also knowing if there’s any point in bringing that patient in at all,” she says. Results of that project are expected to be published in August.
Nodgren says in Asian markets, where there is an aging population and the younger populations are moving to the city, elderly care has been disrupted. Meanwhile, traditionally Western diseases like obesity and cardiac disease are becoming more common in Eastern countries. These are areas where she thinks handheld ultrasound can make a big difference.
The projects Trice Imaging is involved with are not the only ones of their kind. As part of its Cape Town to Cairo road show, Philips Healthcare has unveiled its Visiq tablet ultrasound to address issues of maternal and infant care in remote areas. GE designed the Vscan Access specifically for midwives, general practitioners, paramedics, and clinical officers in developing regions of Africa and Southeast Asia.
There was a time when the capabilities of today’s handheld ultrasounds could outperform the refrigerator-size ultrasound machines of yore. It stands to reason then, that as time rolls on the capabilities we now associate with premium ultrasound systems will find their way into more portable, more affordable systems and, in turn, more parts of the world.
A couple of years ago an article appeared in an online publication called Ghana Magazine recapping conversations that had taken place on a Ghanaian radio show called Joy FM’s DriveTalk, suggesting many Ghanaian women expressed reluctance to having an ultrasound. The primary reasons cited for pregnant women to forgo imaging were cost concerns and also diminishing the excitement of meeting their babies for the first time when they entered the world.
When asked what is the main roadblock that keeps handheld ultrasound from becoming the stethoscope of tomorrow, Narula says, “What is revolutionary is hard to accept. A new generation has to adapt to that, and the issue here is the gap between what we used to do and what we should be doing. It’s always difficult to cross that gap.”