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New technologies in ultrasound: high-end drives innovation, commodity products ease workflow
Conventional or B-mode ultrasound has been used as a diagnostic imaging tool for over four decades. Over the last few years, however, ultrasound systems have witnessed a blizzard of developments in their underlying technology. This has catalysed a significant change in the patterns of ultrasound usage vis-a-vis other, older imaging modalities, especially in terms of concerns about the latter – for example, radiation risk in X-rays and computer tomography (CT), and cost for both CT and magnetic resonance imaging (MRI).
Technology drivers
The ultrasound market is largely driven by innovations in underlying technologies and more sophisticated software algorithms, which allow manufacturers to offer smaller, more powerful and complex systems.
Key developments include an acceleration in processing speed and enhancement in the quality of diagnostic images – coupled to advances in contrast-enhanced imaging and precision in the timing of image capture. This has been accompanied by a sharp reduction in noise-to-signal ratios in the final data to optimize spatial, contrast and temporal resolution, including rotatable views for better visualization.
GE’s cSound technology, for example, offers CT level image quality based on advanced algorithms that capture much larger amounts of data than possible previously (by some estimates, about a DVD worth of data per second). The technology also makes pixel-by-pixel selections of the most precise information to display.
Developments in transducers, beam formation
Ultrasound has also made quantum leaps in factors such as transducer sensitivity and beam formation. For example, line-by-line imaging in beamformers has been replaced in some systems by large zone acquisitions, allowing users to view examinations in greyscale and colour Doppler. Meanwhile, retrospective imaging makes it possible to process raw data multiple times, while retention of channel domain data allows for patient-specific imaging.
Because of all the above, clinicians are able to use ultrasound to image blood perfusion and blood flow in vessels with diameters of 2 mm and less, with small vessel beds displayed via Doppler flow false-colour 3-D or greyscale reconstructions. The result is better assessments of organ perfusion, which have traditionally been difficult on ultrasound.
Commodification trends
Take-up of ultrasound has also been recently boosted by a growing commodification trend. Certain categories of ultrasound have become relatively inexpensive, mobile and less demanding of power. Mobility-related innovations include portable hand-held devices, and more recently, the world’s first wireless transducer. Even some low-end machines are now enabled for full bi-directional communication with electronic medical records.
As healthcare reforms and budgetary pressures favour use of cost-effective solutions, this has led to especially sharp growth in the use of low- and mid-range ultrasound systems. It is now commonplace, for example, to see ultrasound systems in a recovery room, next to hospital beds, or equipping NGOs at health outreach projects in developing countries.
For many hospitals, this kind of product/technology mix makes sense, since not all patients require the sophisticated features offered by high end machines, while their smaller, inexpensive counterparts provide solutions for an everyday challenge faced by most hospitals – workflow bottlenecks.
High-end remains motor for new applications
At the other end, the high-end segment is leading innovation not only in ultrasound technologies, but driving the overall medical imaging market, too. Despite their cost, the advanced features of premium systems have moved ultrasound well beyond traditional applications such as ob/gyn to interventional cardiology and internal medicine. Several ER clinicians, for instance, now routinely utilize ultrasound for echocardiograms and abdominal imaging, while radiologists and surgeons use it to guide needle placement or perform bone sonometry.
Some cutting-edge areas – such as matrix transducers – remain ensconced in the premium category. Matrix transducers have direct relevance to two fast-emerging applications, namely volumetric ultrasound and 3-D/4-D applications.
Key developments
Given below is an overview of key recent developments in ultrasound systems.
Mobility and Ergonomics
Ergonomics and mobility are being addressed by vendors in order to differentiate their systems and grow user volumes. Some surveys suggest that over three out of four of ultrasound users experience work-related pain, with a fifth of these suffering a career-ending injury.
New-generation ultrasound systems stand out in terms of design. Most are noiseless to permit sonographers to minimize distraction and focus on the exam, with settings customized and organized depending on clinical preferences.
Some have slanted bodies to prevent users hitting their knees or feet on the machine, with keyboards that can be raised or lowered depending on user height, probes that are shaped to the human palm and rotatable LCD monitors for sharing the display with colleagues. Other innovations include the possibility of use in both sitting and standing positions, with memory features to accommodate different users.
Some recent ultrasound machines have tablet-sized touchscreen-based interfaces, which significantly reduces the reach and steps (in some cases by 15-20%) in order to start and complete an exam. This enables faster workflow. Touchscreens allow users to tap in order to start functions, pinch and drag to zoom in and out, and swipe to expand the image. Some vendors offer exam presets, with several enhanced functions such as continuous wave Doppler or transducers.
Miniaturization
As discussed below, there is an increase in the use of ultrasound as an alternative to CT and MRI in many point-of-care (PoC) settings. One of the reasons for the trend is mobility as well as increasing miniaturization. Smaller ultrasound machines provide solutions to concerns about cables or wheeling bulky machines around patient rooms, and address tight space demands in key hospital settings such as the operating room. Compact models can be transported by being wheeled or atop a cart.
In some cases, smaller portable machines can also be moved between departments within a hospital or clinic – on a user’s back.
Enhanced quality drives ultrasound to point of care
Ultrasound images today are available with far-higher resolutions than in the early 2000s, when most physicians were used to pictures being fuzzy. One of the key reasons is enhancement in real-time computer processing of images.
Superior image quality has also driven ultrasound to the point-of-care (PoC) setting – both for diagnostic and interventional procedures. PoC ultrasound is now widely available in operating theatres and emergency rooms. Between 2010 and 2013, anesthesiologists are reported to have doubled the use of ultrasound procedures, and ultrasound is also far more common today in certain interventional procedures such as image-guided biopsies and ablations, previously dominated by CT and MRI.
Volumetric ultrasound development
Volumetric ultrasound allows superior characterizing of tissue and the performance of procedures with far greater accuracy.
Ultrasound was previously only able to capture a single imaging plane, but it can currently acquire volumes. This is because transducers which enable the acquisition of real-time volumes of tissue and allow imaging in multiple planes such as the transverse and sagittal have recently become available. For instance, transducers can detect the altered speed of high-frequency sound waves through adipose layers versus other tissue, and make the system aware of increased adipose content.
Though several new-generation transducers remain expensive, in areas where they make a difference, the added price tag is becoming justified. For instance, high-resolution matrix transducers are finding use in interventional cardiology applications such as trans-esophageal echocardiogram (TEE) and 4D imaging.
3-D/4-D imaging
While 2-D continues to be widely used in clinical applications, recent technological advances such as matrix transducers have been enabling factors and triggered interest in 3-D and 4-D ultrasound.
3-D/4-D ultrasound has a more rapid acquisition rate of datasets and subsequent improved image visualization.
4-D imaging consists of the three spatial dimensions as well as the element of time. It projects a cinematographic, motion picture view of an organ or a specific part of an organ, and is emerging as the next generation in advanced imaging.
In combination with advanced visualization functions, 4-D ultrasound aids complex surgical applications and interventional procedures. Multiplanar reconstructed (MPR) images are now available for review in the same manner as CT and MR scans.
Leading imaging vendors already offer 4-D imaging products – across all modalities, PET/CT, MRI and ultrasound. However, 4-D ultrasound is capturing a great deal of interest in applications where ultrasound has already made a case for itself, due to cost, mobility or radiation concerns.
The close connection between 4-D and ultrasound dates back to cutting edge efforts in the early 1980s, when a Duke University team determined that although MRI was faster, ultrasound was the closest to “achieving 3D real time acquisition.” The researchers, led by Dr. Olaf von Ramm, developed a single-transmit, multiple-receive ultrasound scanner called Explosocan to increase data bandwidth.
Elastography
One of the most revolutionary technologies in ultrasound consists of elastography, which utilizes B-mode ultrasound to measure the mechanical characteristics of tissues, which are then overlaid on the ultrasound image. This provides physicians the ability to view stiffer and softer areas inside of tissue, with image quality and clinical outcomes equivalent to X-Ray, MRI, and CT.
Elastography techniques include strain elastography and shear wave elastography (SWE). It has begun proving its use in the characterization of thyroid nodules, lymph nodes and indeterminate breast lumps as well as the detection of prostate cancer. None of these were achievable via conventional ultrasound.
The application which has generated maximum attention is liver fibrosis staging. Biopsies are not only invasive but carry bleeding and infection risks. Elastography, which can be repeated as often as required, is being seen as a way to get the data needed by clinicians to diagnose and stage liver diseases without the associated complications. Elastography is also used to predict complications in patients with cirrhosis.
SWE in particular is also seen as a tool to assist in earlier detection of conditions such as Hepatitis C, and both fatty liver and alcoholic liver disease. Alongside lab studies, it offers a means to closely monitor the impact of treatment and assess if the liver will normalize. For many hepatologists, fighting a liver condition before Stage 4 cirrhosis provides a good chance of reversibility.
SWE can also provide information on which Hepatitis C patients might benefit from viral therapy.
From smartphone apps to AI: the future
App-based ultrasound have recently been showcased. These use transducers connecting via a USB port to a mobile device and a downloadable app. The transducer performs data acquisition, processing and image reconstruction. The result is an ultrasound feature in a consumer-grade smartphone.
Some vendors have launched artificial intelligence systems to enhance speed and automatically take image volume data from 3-D echo to recreate optimized diagnostic views. In cardiac echo in particular, the result offers major potential by permitting reproducibility of imaging.
Nevertheless, such cutting edge technologies are still in their infancy. Only time and user experience will determine their eventual success.
Geriatric emergency medicine – growing patient numbers drive demand
Just like pediatric emergency units were developed to serve children, healthcare experts are recognizing that older adults require specialized forms of emergency care, which differ from the general population. Indeed, emergency rooms can be unforgiving for the elderly, many of who are often traumatized by the experience.
New geriatric emergency departments have recently begun to emerge, led by the US. They not only provide more appropriate care for older people, but can bring cost savings to a hospital, too.
A major and growing challenge
In the US, up to 25% of ED patients are aged 65 years or older. Indeed, geriatric ED patients represent 43 percent of all admissions, including 48 percent admitted to the intensive care unit (ICU). Geriatric patients in the ED also have an average length of stay that is 20 percent longer than younger populations.
There are no consolidated figures for Europe. However, there are both similarities and differences vis-a-vis the US. In the UK, a Nuffield Trust report in 2009 found nearly 40 percent of all ED admissions being for the over-65s and 10 percent for people aged 85 and above. However, it also observed that “at most, 40 percent of the increased number of emergency admissions” over a four-year period could be explained by the effects of population ageing.
The numbers of elderly are not insignificant.
In the US, the 2010 Census found 13 percent of the population, corresponding to over 40 million people, were over 65 years in age. Their numbers too showed a sharper increase than other population groups, with people in the 85+ age group growing at almost three times the rate of the general population.
The situation in Europe is even more demanding, with 19.2 percent of the population in the 65+ age group in 2016, up from 16.8 percent a decade previously.
Benefits for both elderly and hospitals
There are several benefits which the elderly can derive from a geriatric ED. The most important is optimization of care. This is achieved by focusing resources, attention and capability to their most common risks and needs; the latter differ in several respects from other age groups.
Conversely, a geriatric ED can also provide benefits to a hospital. Improved standards of care for a large patient population are a useful marketing or public relations tool. In the US, hospitals have been marketing the geriatric ED to attract older patients who utilize higher reimbursing programmes. Finally, the case for special geriatric attention has become compelling due to the Affordable Care Act. This reduces reimbursement, should a patient return to the hospital due to iatrogenic complications such as infections and wounds.
Paradigm change for both emergency and geriatric care
Traditionally, ED teams were not provided with training for the care of older people. The ED environment was instead organized according to single organ management. For elderly ED admissions, a more holistic approach was considered as best practice, especially in terms of frailty and geriatric syndromes. Several such attitudes continue to this day.
In parallel, geriatric medicine (GM) has historically avoided paying attention to emergency care contexts, and competencies specifically associated with the elderly (e.g. management of falls, confusion, dementia, delirium, the risk of adverse drug-drug or drug-food interactions); these are as important in an acute care setting as in a geriatric ward. Indeed, various studies have pointed out that underlying vulnerabilities which led to an ER visit may go undetected and unaddressed by emergency room staff.
Compelling evidence
However, it has also become clear that dedicated geriatric EDs can make a major difference in delivering quality care to the elderly. One study used Medicare data from 2012 and 2013 to study falls by the elderly, a significant cause of morbidity – leading to hip fractures and nursing home admissions. The researchers found that less than 4 percent received a physical therapy (PT) consult. On the other hand, they also discovered that readmission rates for another fall within 60 and 180 days dropped significantly in patients who had a PT consult.
A brief history of the geriatric ED
The concept of a geriatric ED took root in the US in 2008. Since then, such facilities have become increasingly common in the country. Figures from the non-profit ECRI institute state there were 50 geriatric EDs in operation in the US in early 2014, with another 150 in development.
The first American hospital to develop a geriatric ED model was Holy Cross Hospital in Silver Spring, Maryland, part of the St. Joseph Mercy Health Systems. The geriatric practice was inspired by the fact that nearly one of five of its ED patients was 65 or older. Moreover, its CEO made a more prosaic observation – that the hospital’s ED was not well suited to take care of his mother.
The Holy Cross Hospital was used to pilot the concept of a geriatric ED. Since then, other St. Joseph Mercy’s hospitals have developed geriatric EDs, as have other hospital groups.
In 2012, the Icahn School of Medicine at Mount Sinai received an award from the US government’s Department of Health and Human Services to implement a geriatric ED model at three major urban hospitals, namely Mount Sinai Medical Center in New York City, Northwestern Memorial Hospital in Chicago and St. Joseph’s Regional Medical Center at Paterson, New Jersey.
Common sense innovations
The practices prescribed by Holy Cross for its pioneering geriatric ED involved simple environmental standards such as natural glare-free lighting, soothing colours, beds rather than gurneys equipped with better mattresses and non-skid flooring. Posters and scales were equipped with larger print, and reading glasses made available. The designers also ensured that rooms/units were large enough to accommodate family members, whose role in care delivery of the elderly is now widely acknowledged.
Staff training
However, the most important developments at the Holy Cross ED concerned staff training and responsibilities. ED staff were given special training in geriatrics, while pharmacists were charged with reviewing medications of every elderly patient, to monitor and analyse them as causative factors for a medical emergency. Lessons from Holy Cross, including the maxim that geriatrics care is the ‘ultimate team environment’, have been transferred to other US healthcare facilities and to hospitals in Europe and elsewhere too.
The expertise a well-trained ED team bring to interactions with a geriatric patient directly impact the latter’s condition. Studies have shown that trained ED staff also lead to the use of relatively less expensive outpatient treatments.
The advantage of training nurses for an ED role was highlighted by the ‘Journal of the American Geriatrics Society’ in January 2018. The article, which studied 57,287 patients over 65, reported that an ED-based transitional care nurse (TCN) programme focused on geriatric care was able to reduce the number of unnecessary hospitalizations by 33 percent. Its co-author, Scott Dresden, MD, an Assistant Professor of Emergency Medicine at Northwestern University wrote that the programme “created an otherwise non-existent safety net for this vulnerable population.”
Holy Cross’ first ED also ushered in a full-time, trained geriatric social worker, dedicated to emergency rooms. According to some estimates, geriatric ED patients are 400% more likely to require social services than the general population. Indeed, social workers play a key role in advising and assisting elderly patients to get post-ED care, after discharge. They also seek to know the patients and discover underlying reasons for their coming to the ED.
Reducing re-admissions and penalties
Overall, US hospitals are being compelled by the Affordable Care Act to reduce iatrogenic complications in the elderly. One study showed that 40 percent of emergency room patients older than 65, who had been denied admission, returned to EDs with conditions which had worsened. An article in ‘Modern Physician’ found that 27 percent of elderly patients either returned to the ED for admission or died, in the first three months after a hospital visit.
The ‘Modern Physician’ article, however, observed that 30-day readmission rates for the elderly at Holy Cross Hospital halved after it set up a geriatric ED, from 10.9 percent to 5.2 percent. Results at another geriatric ED, at St. Joseph Regional Medical Center in Paterson, New Jersey, were even more dramatic: returns of elderly ED patients dropped from 20 percent to just over 1 percent.
Guidelines
Geriatric ED practices are the target of new guidelines in the US, developed by The American College of Emergency Physicians (ACEP), the American Geriatrics Society (AGS) and the Society for Academic Emergency Medicine (SAEM). These call for education and training of medical staff, making specific risk-assessments of senior patients and screening those considered to be vulnerable for co-morbidities such as cognitive problems, falls, etc., performing a comprehensive review of medication, and providing a comprehensive discharge plan.
As part of their geriatric risk management, some hospitals are emphasizing the screening and triaging of elderly patients beyond their primary complaint. One popular tool here is the Identification of Seniors at Risk (ISAR), a simple patient checklist to be completed at the point of entry.
Another innovation is the use of telemedicine as part of ED discharge plans, with a typical 72 hours of coverage at home via video monitoring, and then transitioning care to a primary care physician.
Accreditation
On its part, ACEP has recently launched an accreditation programme for emergency rooms, with three levels of accreditation — basic, intermediate and advanced.
All ACEP accredited facilities must provide elderly patients with walkers, canes and reading glasses. Intermediate accreditation requires provision of suitable lighting and non-slip floors, along with hearing aids, thicker mattresses and warm blankets. Advanced accreditation targets physician-supervised improvement initiatives, such as limiting the use of urinary catheters in older patients.
Europe launches GEM curriculum
In Europe, too, efforts are being made by professional societies to develop a validated curriculum on geriatric emergency medicine (GEM). The curriculum is thorough and covers a full spectrum of activity: pre-hospital care, primary clinical assessment and stabilization, secondary clinical assessment, medication, pain management, palliative care and transitional care, along with continuous attention to typical co-morbidities in the elderly and to differences in care paradigms and challenges vis-a-vis younger age groups.
Geriatric friendly – a new standard?
In the long run, we may well witness some major re-thinking about the impact of geriatric ED. Mark Rosenberg, who heads geriatric emergency medicine at St. Joseph’s – one of the three hospitals that received US government funding in 2012 for implementing a geriatric emergency practice – suggests that if an ED is designed for the most vulnerable patients, it will work for the strongest patients as well. In other words, he argues that all EDs should be designed to be geriatric-friendly, as a baseline standard.
DBT makes major stride with Hologic’s launch of innovative mammography system
At the European Society for Breast Imaging (EUSOBI) meeting last September in Berlin, Hologic officially launched the 3Dimensions™ mammography system which offers a variety of groundbreaking features designed to provide higher quality 3D™ images for radiologists, enhanced workflow for technologists, and a more comfortable mammography experience, with low-dose options, for patients (see featured item).
On this occasion, International Hospital talked to Lori Fontaine, Vice President of Clinical Affairs for Hologic.
Is the launch at EUSOBI only for Europe or is it global?
The 3Dimensions™ mammography system received CE Mark in July 2017 making it commercially available in EMEA, followed shortly thereafter by the U.S. launch in August 2017.
Can you give some details and figures on dose reduction for the new system?
We know that dose is a common concern across Europe, and the 3Dimensions system helps address this by providing low-dose options for patients, among many other benefits. The 3Dimensions system results in a 45 percent dose reduction with a generated 2D image compared to 2D FFDM alone.
Is the improvement in image clarity regardless of breast density likely to reduce the need for a secondary ultrasound in the screening of high density breasts?
We already know the 3Dimensions system’s Clarity HD high-resolution 3D™ imaging reduces recalls by up to 40 percent compared to 2D alone, and given Clarity HD works to deliver exceptional 3D™ images, regardless of breast size or density, it makes sense that the 3Dimensions system would be an ideal option for women with dense breasts. This is especially true since the 3Dimensions system operates in tandem with Hologic’s 3D Mammography™ exam, the only mammogram approved by the U.S. Food and Drug Administration as superior for women with dense breasts compared to 2D alone, which further demonstrates that tomosynthesis should be the standard of care for women across the globe when it comes to breast cancer screening.
Do you have any information and figures on the adoption rate of DBT by radiologists in the various European countries, are there significant country variations (or regional between US, Europe and Asia)?
Digital Breast Tomosynthesis (DBT) adoption rates vary by country. While DBT has been approved in EMEA since 2009, the majority of EMEA countries limit the use of DBT to diagnostic imaging as they have concerns regarding dose and reading time. Hologic remains at the forefront of technology innovation and is working to overcome these barriers, so that all women can be screening with DBT.
Hologic was the first company to receive FDA approval for DBT use in both the screening and diagnostic setting in the U.S. in 2011. Today, DBT is used in approximately 40 percent of all U.S. screening mammography exams and is covered by the majority of insurance companies. The evidence of the benefit of Hologic’s 3D Mammography exam as a better mammogram continues to expand and resulted in the addition of DBT to the National Comprehensive Cancer Network (NCCN) Guidelines in 2016. NCCN is recognized globally as an alliance of 27 U.S. cancer centers that develop recommendations designed to help healthcare professionals diagnose, treat and manage cancer care.
Cancer : new challenges lying ahead
Cancer remains the second leading cause of death in Europe after cardiovascular diseases with approximately 3.5 million new cases diagnosed every year and an annual death toll of 1.5 million. However, the good news is that the trend of total cancer mortality levels is downwards for both men and women and also children for which the progress of 5-year leukemia survival has been spectacular.
Breast cancer provides a good example of this trend, being not just the most common female cancer globally but also the number one diagnosed cancer in Europe (13%). Its 5-year survival rate has more than doubled in 40 years, from 40% of patients in 1970 to 90% in 2013. Looking into the future there are also some encouraging signs for certain types of cancer, particularly cervical cancer as the full impact of the HPV vaccination programmes becomes measurable.
In Europe, some of the credit for these positive developments should go to the European Organization for Research and Treatment of Cancer (EORTC), founded in 1962. Over the years, EORTC’s clinical research has helped make significant progress in the treatment and management of cancer, evaluating new molecules, refining existing treatment regimens, identifying biomarkers and assessing patients’ qualify of life. In 2016, the EORTC research network counted more than 4850 physicians from about 870 institutions while patient accrual from 2000 to 2016 totalled over 89,000 patients in clinical studies.
The bad news is that the overall burden of cancer continues to increase not just because of progress in early detection but largely because of the ageing of the population (65% of new cancer cases are diagnosed in patients who are 65 or older). Also, smoking, particularly in women, is linked to a rising incidence of lung cancer.
There are still a number of challenges to be met if the promises of translational research and personalized medicine for cancer therapy are to be fulfilled. Effective coordination in Europe of advances in basic research and quality clinical research programmes is essential. New models of partnerships between academia and the pharma industry are also required as well as public funding for research on rare cancers. Prevention is paramount, though, as no cancer research will have a bigger and quicker impact than smoking cessation. Tobacco kills over one third of its users and studies have shown that smokers lose at least 10 years of life expectancy compared to non-smokers and that quitting smoking before the age of 40 reduces the risk of tobacco-related death by 90%.
