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Studies Show How Breast Ultrasound Reduces Unnecessary Biopsies
Multiple scientific presentations showed how careful use of ultrasound could allow imagers to so precisely characterize lesions that women could avoid biopsies...
The makers of MRI machines and CAT scanners the size of minivans are now rolling out handheld ultrasound machines just slightly larger than iPhones...
Early Pregnancy Determines Late Outcomes
Growth of the fetus during the first trimester -- when essential organ development is completed -- lays the foundation for important outcomes in pregnancy and early childhood...
The risk for DVT is low for 3 months after a single negative result on whole-leg compression ultrasound (CUS) examination...
Pregnant women and new mothers will be able to get health information delivered regularly to their mobile phones by text message at no charge under an innovative public service program...
Studies Show How Breast Ultrasound Reduces Unnecessary Biopsies
Multiple scientific presentations showed how careful use of ultrasound could allow imagers to so precisely characterize lesions that women could avoid biopsies...
Breast ultrasound is having its moment. Multiple scientific presentations at the RSNA 2009 meeting showed how careful use of ultrasound could allow imagers to so precisely characterize lesions that women could avoid biopsies.
During one session investigators revealed ultrasound elastography could be an effective means of reducing unnecessary breast biopsy. During another, the researchers found targeted breast ultrasound by itself is also a safe and effective alternative to biopsies.
An ongoing study of 179 patients found ultrasound elastography correctly identified 98% of malignant lesions and 82% of benign lesions. Elastography also enabled researchers to accurately measure lesion size. Standard B-mode ultrasound may underestimate some lesions as it visualizes only the actual mass and not its surroundings. Elastography measures the stiffness of a lesion and more easily distinguishes between a fluid-filled abnormality and a malignant cancer, said lead author of the study Dr. Stamatia Destounis, a radiologist at Elizabeth Wende Breast Care in Rochester, New York.
Elastography software, which allows testing of tissue elasticity with little transducer pressure, can be added to existing standard ultrasound equipment, she said. Potentially it can prevent unnecessary needle biopsies from taking place. Another session showcased studies illustrating targeted breast ultrasound’s ability to decrease the harms and costs associated with unnecessary surgery.
Two retrospective studies of ultrasound examination for focal breast signs or symptoms (i.e., pain), one on women younger than 30, one on women between 30 and 39, were presented by senior investigator Dr. Constance D. Lehman, vice chair of radiology at the University of Washington in Seattle.
In one study, 1123 female patients under the age of 30 who underwent ultrasound for breast signs and symptoms were identified. Of 1091 lesions found in 830 patients, biopsy found cancer in three of 168 patients for whom the procedure was recommended. No other cancers were found in two years of follow-up.
The overall incidence of cancer in women under 30 is very low. Ultrasound has 100% sensitivity in this setting, which supports its use as a primary imaging modality, Lehman said.
The second study looked at 1327 cases identified in women between the ages of 30 and 39 who underwent both targeted ultrasound and mammography. Twenty six cases (2%) were found to be malignant; all of these were detected by ultrasound. None of the malignant cases, however, was detected by mammogram alone.
Lehman also discussed the possibility of using ultrasound, rather than doing a biopsy or performing surgery, to test BIRADS 3 lesions that are probably benign lumps. In the first study, a third of the patients with BI-RADS 3 lesions opted to undergo tissue sampling, and none were found to be malignant.
“With these data we can be much more reassuring to patients on the very low likelihood of malignancy in these probably-benign lesions. In fact, in our hands it was 0%,” said Lehman, who is also director of breast imaging at the Seattle Cancer Care Alliance.
Article written by staff at diagnosticimaging.com and adapted for the purposes of this newsletter.
General Electric (GE) Healthcare is Latest to Make Handheld Ultrasound
The makers of MRI machines and CAT scanners the size of minivans are now rolling out handheld ultrasound machines just slightly larger than iPhones...
The makers of MRI machines and CAT scanners the size of minivans are now rolling out handheld ultrasound machines just slightly larger than iPhones, hoping they'll become as commonly used as stethoscopes.
Manufacturers including General Electric Co. and Siemens AG expect doctors, nurses, paramedics—even veterinarians—to carry the devices at all times, making it handy to check for internal injuries or clues of cardiac trouble. While the images aren't as good as those produced by traditional ultrasound, the manufacturers are betting the convenience will spur their use, opening up a global market GE executives think could be worth $1 billion per year.
The proliferation of devices raises questions about whether rank-and-file medical staff can be trained to use the machines properly. It also needs to be established exactly what insurance companies will pay for.
Still, manufacturers are pushing ahead. GE just unveiled its vScan machine, which is the size of a cell phone and, with regulatory approval, will go on the market as early as Monday for less than $10,000.
Siemens is updating its Acuson P10 handheld scanner that came out in 2007 and is selling roughly 600 of them a year, a modest number. Signostics, a smaller firm from Palo Alto, Calif., released its $4,000 Signos Personal Ultrasound machine in the U.S. early last year and declined to share sales data. Other makers are making tablet-style ultrasound machines.
The handhelds threaten to displace sales in the existing $5 billion global market for laptop-sized ultrasound machines that cost as much as $50,000, as well as traditional cart-based ultrasound machines that weigh as much as refrigerators and cost as much as $250,000 apiece.
"Right now, it's the most dynamic segment within the ultrasound market," said Antonio Garcia, research manager for Frost & Sullivan's Medical Imaging Group, referring to laptops and handheld machines. His firm predicts 7.5% growth in the portable ultrasound market, which produced $680 million in revenue globally in 2008, compared with growth of just 1% in the overall ultrasound market.
GE Healthcare executives think the handhelds could reduce the need for tests and referrals during physical examinations, and could make health care more accessible to patients in the U.S. and in emerging markets. "Our vision is that, one day, every clinical procedure will require ultrasound the way everything requires a stethoscope today," said Omar Ishrak, president and CEO for clinical systems at GE Healthcare.
Jerry Westerfield, a radiologist in Russell Springs, Ky., already uses laptop-sized scanners to help him locate veins for an intravenous line or to place a stent in an artery. A handheld device would "save me tons of time and fewer sticks," of the needle, he said. But he also sees risks to spreading around cheaper, portable scanners in emergency medicine or bedside care. "You have to be trained to use it," Dr. Westerfield said.
Ultrasound technicians currently attend two- and four-year college programs or are trained at hospitals. Some doctors and nurses also get sonography training. States don't require a license, although the American Registry for Diagnostic Medical Sonography and other groups provide certification. Mr. Ishrak of GE Healthcare said the company is working with groups to set training guidelines.
"We want to do it responsibly," he said. The company will start selling vScan machines as early as Monday to some doctors and hospitals for early testing.
Charlotte Henningsen, chair of sonography at Florida Hospital College of Health Sciences in Orlando and president of the Society of Diagnostic Medical Sonography, has tried the vScan and said it will be useful as a companion to the stethoscope. But she warned it should only be used by trained staff. For example, an EMT with marginal sonography skills might scan a patient for internal injuries, spotting some and missing others.
Acquiring and interpreting ultrasound images requires knowledge of cross-sectional anatomy and lots of training, said David Jaslow, chief of emergency medicine at Albert Einstein Healthcare Network in Philadelphia. Still, Dr. Jaslow, a specialist in disaster relief, thinks the devices will "be the most significant technological advancement" to diagnose a variety of conditions in a disaster settings like earthquakes.
At least two hospitals are training staff to use the Siemens Acuson P10 and plan to publish papers on the results. Pamela Wickkiser, radiology director at Humboldt General Hospital in Winnemucca, Nev., has paramedics using the devices in ambulances on a practice basis. "They are actually picking the skills up pretty well," she said. "For us, being so rural out here, it would be a big plus to get this kind of information pre-hospital."
Bruce Kimura, a cardiologist at Scripps Mercy Hospital in San Diego who is testing several devices, said the idea they could replace stethoscopes "is not crazy. It could happen." Two years ago, he scanned one patient's neck with the P10 and found her carotid arteries were clogged. The exam took a few minutes in the doctor's office and may have prevented a future stroke.
Ultrasound imaging came about after World War II and borrows technology from sonar equipment for ships at sea. The device emits sound and detects returning echoes, producing computerized images of body organs. Doctors like the technology because it isn't invasive, doesn't use radiation and provides images in real time.
The poorer image quality of handheld ultrasound scanners and questions about insurance reimbursement could limit their growth. Insurers have already been lowering reimbursement rates for other scans, and GE doesn't yet know whether use of its vScan will be reimbursable. "Is there a reimbursement code for this? No there's not," said Dr. Kimura. "That's a problem."
A handheld that meets certain qualifications, including the ability to permanently record images with measurements, "would be paid at the same level as other diagnostic ultrasounds," said Tammy Arnold, a spokeswoman at medical insurer Aetna. Those that don't would be considered part of a physical examination and wouldn't be separately payable.
A number of companies including Toshiba Medical Systems Corp. and Hitachi Medical Corp. make laptop-sized ultrasound machines but aren't planning to offer handhelds yet. Philips Medical Systems Americas Inc. offered an OptiGo handheld ultrasound device nearly 10 years ago, but pulled it from the market because of weak sales. Executives there are skeptical of the image quality and whether there's even a need for something more portable than a laptop.
Others believe it's only a question of time. George Stagakis, head purchasing agent for the Children's Hospital of Wisconsin in Milwaukee, said there will definitely be a market. At a recent imaging show in Chicago, he was looking to buy handheld devices doctors can use to check for heartbeats and fluid around the heart. Obstetricians, he said, would just roll the cost into their normal fee.
Article written by staff at online.wsj.com and adapted for the purposes of this newsletter.
Early Pregnancy Determines Late Outcomes
Growth of the fetus during the first trimester -- when essential organ development is completed -- lays the foundation for important outcomes in pregnancy and early childhood...
Growth of the fetus during the first trimester -- when essential organ development is completed -- lays the foundation for important outcomes in pregnancy and early childhood, Dutch researchers found.
Restricted first-trimester growth appeared to more than double the risk of preterm birth, low birth weight, and small size for gestational age at birth in a prospective study led by Vincent W.V. Jaddoe, MD, PhD, of Erasmus Medical Center in Rotterdam.
Infants who didn't grow as much as expected during the first trimester also showed accelerated "catch-up" growth up to their second birthday -- a well-established risk factor for later metabolic and cardiovascular disease.
"It could be that growth as early as in the first trimester of pregnancy is associated with disease in adulthood, although longer follow-up studies are necessary to examine this relationship," the researchers wrote in the Journal of the American Medical Association.
This and prior studies suggest that women at high risk of problems late in pregnancy could be identifiable in the first trimester, with the potential for trials of screening and early intervention, according to an accompanying editorial by Gordon C.S. Smith, MD, PhD, of the University of Cambridge, England.
The challenge, Smith wrote, will be to "produce robust screening tests with acceptable levels of detection and prediction, and to identify interventions that are effective in improving outcome when a pregnancy has been identified as high risk."
The researchers' population-based, prospective Generation R Study included 1,631 pregnant women in Rotterdam with a known and reliable first day of their last menstrual period and a regular menstrual cycle.
Fetal crown-to-rump length, measured by ultrasound between the gestational ages of 10 weeks 0 days and 13 weeks 6 days, is typically used to determine gestational age. But in this study it served as the main parameter of first-trimester fetal growth.
Predictors of restricted fetal growth in multivariate analyses included the following (given as standard deviation growth score):
- Younger maternal age (0.10 per 4.68-year standard deviation increase, P<0.001)
- Higher maternal diastolic blood pressure (−0.05 per 9.52-mm Hg standard deviation increase, P=0.03)
- Higher hematocrit level (−0.07 per 2.50% standard deviation increase, P=0.02)
- Smoking (−0.13, P=0.03)
- Folic acid supplement use (0.17, P=0.03)
After adjustment for multiple testing, only hematocrit and maternal age remained significant factors, but smoking and non-optimal use of folic acid supplements together produced a significant reduction in first-trimester fetal growth (SD score −0.52, 95% CI −0.78 to −0.25, P<0.001 for interaction).
Higher hematocrit levels may indicate lower circulating plasma volume. That, in turn, could lead to suboptimal placental perfusion, the researchers suggested as a possible explanation for the importance of this factor.
The impact on pregnancy outcomes was significant for all adverse birth outcomes assessed. Compared with normal first-trimester fetal growth, growth restriction was associated with the following risks:
- 2.12-fold higher adjusted odds of preterm birth before 37 weeks' gestation (4.0% versus 7.2%, P=0.006)
- 2.42-fold higher adjusted odds of low birth weight, defined as less than 2,500 g or 5 lb 8 oz (3.5% versus 7.5%, P=0.001)
- 2.64-fold higher adjusted odds of being small for gestational age at birth, defined as in the lowest 20% (4.0% versus 10.6%, P=0.001)
Independent of birth weight, fetal growth restriction in the first trimester accelerated postnatal growth until age 2 years (0.139 standard deviation score increase over two years per standard deviation fetal-crown-to-rump length decrease, P<0.001). Even though they included only women with reliable menstrual cycles, the authors noted, misclassification of gestational age might still have been an issue, depending on timing of ovulation and implantation.
"Further studies are needed to assess the associations of first-trimester growth variation on the risks of disease in later childhood and adulthood," they concluded.
Article written by staff at medpagetoday.com and adapted for the purposes of this newsletter.
Risk for Deep Vein Thrombosis (DVT) Low After Single Negative Whole-Leg Compression Ultrasound Result
The risk for DVT is low for 3 months after a single negative result on whole-leg compression ultrasound (CUS) examination...
The risk for deep vein thrombosis (DVT) is low for 3 months after a single negative result on whole-leg compression ultrasound (CUS) examination, according to the results of a systematic review and meta-analysis reported in the February 3 issue of the Journal of the American Medical Association.
"In patients with suspected lower extremity...DVT, ...CUS is typically the initial test to confirm or exclude DVT," write Stacy A. Johnson, MD, from University of Utah School of Medicine in Salt Lake City, and colleagues. "Patients with an initial negative CUS result often require repeat CUS after 5 to 7 days. Whole-leg CUS may exclude proximal and distal DVT in a single evaluation."
The goal of this study was to assess the risk for venous thromboembolism after withholding anticoagulation in patients with suspected lower extremity DVT after a single negative whole-leg CUS result. The reviewers searched MEDLINE, EMBASE, CINAHL, LILACS, Cochrane, and Health Technology Assessments databases for relevant articles published from January 1970 through November 2009, as well as Internet resources and bibliographies of retrieved articles. Content experts were also contacted.
Inclusion criteria were randomized controlled trials and prospective cohort studies of patients with suspected DVT and a negative whole-leg CUS result who were not treated with anticoagulants and who were followed up for at least 90 days for venous thromboembolism events. Data on a single positive or negative whole-leg CUS result, venous thromboembolism during follow-up, and study quality were independently extracted and reviewed by 2 authors.
Selection criteria were met by 7 studies, enrolling a total of 4731 patients, with negative whole-leg CUS results who did not receive anticoagulation. Among the participants, most of whom were identified from an ambulatory setting, up to 647 (13.7%) had active cancer, and up to 725 (15.3%) had recently undergone major surgery.
Of 34 patients (0.7%) with venous thromboembolism or suspected venous thromboembolism–related death, 11 (32.4%) had distal DVT; 7 (20.6%) had proximal DVT; 7 (20.6%) had nonfatal pulmonary emboli; and 9 (26.5%) died, possibly related to venous thromboembolism. At 3 months, the combined venous thromboembolism event rate was 0.57% (95% confidence interval, 0.25% - 0.89%), based on a random-effects model with inverse variance weighting.
"Withholding anticoagulation following a single negative whole-leg CUS result was associated with a low risk of venous thromboembolism during 3-month follow-up," the review authors write. "Using a single negative whole-leg CUS result as the sole diagnostic modality in patients with high pretest probability of DVT requires further study."
Limitations of this review and meta-analysis include variability in whole-leg CUS techniques, clinical pretest probability with a standardized clinical prediction rule not assessed by most studies, generalizability limited by the populations enrolled, duration of follow-up limited to 3 months, and potential verification bias.
In an accompanying editorial, Robert A. McNutt, MD, PhD, from Rush University Medical Center in Chicago, Illinois, and Edward H. Livingston, MD, from University of Texas Southwestern Medical Center, Dallas, note that evidence-based medicine requires appropriate clinical context.
"For instance, based on the meta-analysis by Johnson et al, clinicians may infer that not initiating anticoagulation treatment after a negative CUS result in some surgical or ambulatory patients at low risk of having VTE [venous thromboembolism] may be appropriate; however, that inference may not be true for hospitalized patients or those with cancer," Drs. McNutt and Livingston write. "Evidence-based medicine must evolve to include clinically and contextually explicit estimates for outcomes as guides to care.
Clinical trials and studies evaluating diagnostic tests should be designed and reported to enable clinicians to maximize the care of individual patients, so they can avoid doing the sometimes right things for the sometimes wrong patients."
Article written by staff at medscape.com and adapted for the purposes of this newsletter.
U.S. Chief Technology Officer Announces Launch of First Free Mobile Health Service for Pregnant Women, New Mothers
Pregnant women and new mothers will be able to get health information delivered regularly to their mobile phones by text message at no charge under an innovative public service program...
Pregnant women and new mothers will be able to get health information delivered regularly to their mobile phones by text message at no charge under an innovative public service program being launched today by a coalition of mobile phone service providers, health professionals, and Federal, State, and Local agencies.
The new program, called text4baby, is a free mobile information service that provides timely health information to women from early pregnancy through their babies’ first year. The service sends important health tips that are timed to the mother’s stage of pregnancy or the baby’s age.
The new service, announced by U.S. Chief Technology Officer Aneesh Chopra at a health technology conference in Washington, D.C., aims to use one of the most widely used technologies in America—the mobile phone—to promote maternal and child health.
Information provided to moms through text4baby will help them take care of their health and give their babies the best possible start in life. Currently in the United States more than 500,000 babies – 1 in every 8 – are born prematurely and an estimated 28,000 children die before their first birthday, a rate among the highest in the industrialized world. Premature babies can face lifelong health and intellectual development problems.
"Text4baby is the first free mobile health service to be taken to scale in the United States," said Aneesh Chopra, Chief Technology Officer for the U.S. Government. "We know that mobile phones hold tremendous potential to inform and empower individuals," said Chopra. "Text4baby represents an extraordinary opportunity to expand the way we use our phones, to demonstrate the potential of mobile health technology, and make a real difference for moms and babies across the country."
Chopra, who also serves as Associate Director for Technology within the White House Office of Science and Technology Policy, introduced the new service in a keynote address at a joint session of the Health IT Summit for Government Leaders, the National Health Information Exchange Summit, and the Eighteenth National HIPAA Summit.
Medical expenses for babies born prematurely average about ten times those for babies born after a full-term pregnancy. All told, premature births cost the Nation tens of billions of dollars—at least $26.2 billion in 2005, according to the U.S. Centers for Disease Control and Prevention.
Ninety percent of Americans have a mobile phone and texting is especially prevalent among women of childbearing age and minority populations, who face higher infant mortality rates.
"Getting connected to prenatal care and other services for a healthy pregnancy is a problem for a lot of women," said Wanda Jones, Principal Deputy Assistant Secretary for Health at the U.S. Department of Health and Human Services. "Text4baby provides pregnant women and new mothers with a new tool to obtain vital information that is critical to maternal and child health."
Women who sign up for the service by texting BABY to 511411 (or BEBE for Spanish) receive three free SMS text messages each week timed to their due date or baby’s date of birth. The messages focus on topics critical to the health of moms and babies, including, nutrition, seasonal flu prevention and treatment, mental health issues, risks of tobacco use, oral health, immunization schedules, and safe sleep. Text4baby messages also connect women to public clinics and support services for prenatal and infant care.
Many U.S. government agencies are involved in the design, outreach, and evaluation of text4baby, and will serve women and babies who learn about their services through the program. These include the Department of Health and Human Services, the Department of Defense Military Health System, and the Office of Science and Technology Policy.
Participating carriers include: Alltel, Assurance Wireless, AT&T, Boost Mobile, Cellular South, Cellcom, Centennial Cellular, Cincinnati Bell, Metro PCS, N-Telos, Sprint Nextel, T-Mobile, U.S. Cellular, Verizon Wireless and Virgin Mobile USA.
Text4baby is an educational program of the National Healthy Mothers, Healthy Babies Coalition (HMHB), made possible through a public-private partnership that includes more than 100 entities. In addition to the Federal partners listed above, founding partners include HMHB, Voxiva, the CTIA Wireless Foundation, and Grey Health Group. Johnson & Johnson is the Founding Sponsor, and Premier Sponsors include WellPoint, Pfizer, and CareFirst BlueCross BlueShield. The mobile health platform is provided by Voxiva and free messaging services are provided by participating wireless service providers. Implementation partners include BabyCenter, Danya International, Syniverse, Keynote Systems and The George Washington University. Other text4baby partners include national health professional associations; national NGOs; state and local government coalitions from across the country; and MTV Networks.
Article written by staff at dctechsource.com and adapted for the purposes of this newsletter.
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