Dr. Laurence Klotz discusses micro-ultrasound as a faster, less invasive, more cost-effective screening strategy compared to mpMRI in this podcast. 

Reading Room Podcast: Micro-Ultrasound for Easier Prostate Cancer Screening

Senior Fellow and Director of the Center for Medical Economics and Innovation at the Pacific Research Institute

Life expectancy in the U.S. has markedly improved over the last century. At the turn of the 20th century, it was 

. By 2017, life expectancy at birth reached nearly 

. Advances in medical innovations are often cited as “one of the greatest contributors” to this progress.

These long-term trends provide important perspective for Congress as it considers re-authorizing the Medical Device User Fee and Modernization Act of 2002 – the next authorization is referred to as MDUFA V.

All new medical devices – the wide range of products that are used to diagnose, treat, monitor, or prevent diseases and conditions – must obtain U.S. Food & Drug Administration (FDA) authorization before the products can be marketed and sold in the United States. Prior to MDUFA, FDA’s review process was widely viewed as inefficient, time consuming, and the FDA rarely met the required deadlines.

For more coverage based on industry expert insights and research, subscribe to the Diagnostic Imaging e-Newsletter

As a result of these inefficiencies, patients’ access to potentially lifesaving or life-enhancing medical devices were unnecessarily delayed, harming health outcomes. From the companies’ perspectives, the delays created uncertainties that made marketing their products more difficult and complicated the process of conducting follow-up studies.

MDUFA is a win-win-win policy that reduces these problems.

How Industry-FDA Cooperation Removed Medical Imaging Device Delivery Delays

For the FDA, MDUFA ensures that the agency has access to the necessary resources to improve its efficiencies. Consider that the 

 for devices that are “substantially equivalent” to a device already on the market (510(k) applications) has fallen from 154 days in 2010 (including the time spent by the FDA and time spent by the applicant responding to the FDAs requests) to 124 days in 2019. The decision time for novel medical devices (PMAs) has been more volatile, but still fell from 467 days in 2013 to 217 days in 2019. Thanks to the resources provided by MDUFA, the FDA is largely meeting is required efficiency goals.

For the manufacturers, the improved speed and predictability of the approval process improves manufacturers’ efficiencies and planning processes. Perhaps most importantly, the expedited review process provides patients with faster access to new medical devices. 

, these new devices include better heart valves, devices that enable minimally invasive spinal correction, and better glucose monitors.

These results strongly support the argument that MDUFA V should be authorized by Congress. The terms of that reauthorization are a bit more controversial.

MDUFA’s benefits are enabled by the act’s user fee structure. There are, undoubtedly, strong arguments in favor of funding the FDA’s review process by levying user fees on the manufacturers submitting devices for approval. There are equally strong arguments that user fees should only partially fund the review process and general tax revenues should also fund a substantial portion of these costs.

It is commonly accepted that government agencies 

 when a limited number of people or businesses benefit from the public service. Taxes, on the other hand, are appropriate when the general population benefits from the public service.

The benefits from the FDA’s medical device review process contain both of these elements. Medical device manufacturers benefit greatly from an efficient review process, but so does the broad patient population. The current blended revenue structure that funds the review process with both MDUFA user fees and general tax revenues balances both types of benefits.

Over time, the revenue structure has been tilting toward an excessive 

 rather than general tax revenues. When first implemented, user fees accounted for approximately one-fifth of total program revenues. The implementation of new fees and increases in rates has caused user fee revenues to grow at double-digit rates and now account for around 44 percent of total revenues.

This excessive growth in user fees is becoming an excessive tax on manufacturers that, if not appropriately managed, will reduce their efficiencies and incent wasteful expenditures on programs that do not enhance the FDA’s mission of performing a comprehensive and timely safety review process of new medical devices. The consequence will be a higher-cost, less efficient, FDA.

It is imperative that Congress recognize these considerations in its upcoming MDUFA reauthorization process. While reauthorizing MDUFA is an important public health policy, the user fee authority should not be used as a slush fund to authorize ancillary programs that do not enhance the agency’s prime directive.

Wayne Winegarden, Ph.D. is a Senior fellow and Director of the Center for Medical Economics and Innovation at the Pacific Research Institute

Articles

Re-authorize MDUFA without raising user fees to fund unrelated programs.

 Medical Device Legislation Should Be Re-Authorized, But Without User Fee Changes

In this week’s preview, here are some highlights of what you can expect to see coming soon on 

Breast Cancer Awareness month will soon be coming to a close, but that does not mean radiology practices and breast imaging centers should relax the attention they pay to patients who come in for breast cancer screening. This week, 

 spoke with breast imaging technologist Stephanie Johnston from Solis Mammography in Texas about what is most important to women when they come in for annual screening, as well as what practices can do to ensure women have the best counters possible.

For additional insights on patient experience, 

For more coverage based on industry expert insights and research, subscribe to the Diagnostic Imaging e-Newsletter 

Stroke remains the leading cause of disability in the United States, as well as a leading cause of death. Given their skill set, radiologists are uniquely positioned for stroke prevention. In a column this week, 

Editorial Board member Mina Makary, M.D., an interventional radiologist from The Ohio State University Wexner Medical Center, shared insights on alternative training models for interventional neuroradiology.

To read our previous coverage of neuroimaging, 

Research efforts are continuing to help providers better understand the development of dementia in patients. This week, we will share investigation results from two institutions that shed light on how this disease affects the brain. Look for this coverage as the week progresses.

Here's what to expect this week on Diagnostic Imaging.

Diagnostic Imaging's A Look Ahead: Oct. 26, 2020, to Nov. 1, 2020

Women of Indian and Pakistani decent are more often diagnosed – at a younger age -- with more aggressive forms of breast cancer, and they could benefit from more culturally targeted screening and prevention strategies, experts have said.

Finding ways to reach these women successfully is critical, according to investigators from Rutgers University because the South Asian population is the fastest-growing group in the United States – and breast cancer rates among these women are increasing. To date, research has provided little data about the disease and this unique population.

To offer more clarity, Rutgers researchers looked at the characteristics of breast cancers in women of Indian and Pakistani descent and compared those findings to results from non-Hispanic white women in the United States. They published their findings Oct. 25 in the 

“Our results provide an insight into breast cancer in Indian and Pakistani women, suggesting several hypotheses to guide future scientific studies to better understand the risk factors influencing disease etiology and prognosis,” said Jaya M. Satagopan, Ph.D., professor of biostatistics and epidemiology and director of the Center for South Asian Quantitative Health and Education at Rutger’s School of Public Health.

Q&A: Breast Cancer Screening Shortfalls for African American Women

To draw these comparisons, Satagopan’s team examined data from the National Cancer Institute’s Surveillance, Epidemiology and End Results Program. They analyzed incidence data from women of Indian and Pakistani descent gathered from 1990 to 2014, as well as disease characteristics, treatment, and survival data captured between 2000 and 2016 for 4,900 women in these groups. In additional, they examined the same data from 482,250 non-Hispanic white women who had breast cancer.

Based on their analysis, they determined that, while breast cancer occurrence was lower in women of Indian and Pakistani descent, the number of diagnosed cancers increased throughout the years studied. Additionally, women in these groups were more likely to be diagnosed with a more advanced-stage disease at a younger age.

As a result, the team said, women of Indian and Pakistani descent received more subcutaneous or total mastectomies than non-Hispanic white women. And, even though they had lower breast cancer mortality than their white counterparts, their health outcomes were tracked for less time.

Historically, Satagopan said, fewer women of Indian and Pakistani descent have participated in scientific research, and many delay seeking necessary health services due to sociocultural factors. Specifically, diminished family support, transportation difficulties, modesty, fear, and beliefs about cancer being a divine punishment for past misdeeds have all factored into poor mammogram screening rates in this group. This is particularly true for women who have lived in the United States less than a decade, have low English proficiency, and do not have confidence in the U.S. healthcare system, she said.

Consequently, the team determined, the industry must devise strategies than can specifically engage women of Indian and Pakistani descent into breast cancer studies, potentially improving their experiences and interactions with healthcare providers. Identifying the sociocultural factors that come into play with their screening and healthcare use decisions is paramount, they said.

“As the South Asian population in the United States grows, it is imperative that we work to promote health equity in cancer prevention, screening, early diagnosis, and treatment through community engagement and a team science approach, said Anita Kinney, Ph.D., RN, director of the Center for Cancer Health Equity at Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey.

Ultimately, the team said, their study findings point to the existence of important differences within this population that support further study. Future research should focus on findings ways to better understand the biological, sociocultural, and system-level factors that impact breast cancer screening patterns and diagnosis, as well as risk and survival rates in women of Indian and Pakistani descent.

More culturally relevant screening strategies could improve preventive healthcare in these groups.

Younger Indian and Pakistani Women Diagnosed with Aggressive Breast Cancer

Despite recent evidence that physician extenders can streamline radiology workflow and reduce turnaround times, radiologists should rely more on artificial intelligence (AI) for assistance than non-physician providers (NPP), a group of industry experts has said.

Journal of the American College of Radiology

a team of experts, led by Daniel Ortiz, M.D., with Summit Radiology in Georgia, pointed to the several benefits of AI – not only do the tools save money and streamline workflow, but they will not encroach on a radiologist’s responsibilities.

For these reasons, they said, radiologists should forego giving physician extenders – the nurse practitioners, physician assistants, and other providers who take on some of a provider’s duties – full practice authority.

“Although labor costs have been reduced and radiologists can focus more on complex imaging studies and interventional procedures, there are unintended consequences of non-physician practitioners in practice that could diminish physician’s role as healthcare providers,” the group wrote. “Therefore, we encourage radiologists to consider an alternative to non-physician practitioners in radiology: the incorporation of rapidly evolving artificial intelligence algorithms into daily practice.”

Radiology Extenders Outperform Radiology Residents with Chest X-ray Interpretations

Their concern was spawned by a recently passed Georgia law that allows advanced practice registered nurses to order CR, MRI, and other imaging exams under certain circumstances. Some pockets of support in healthcare have heralded the measure as a way to both decrease labor costs and take less complicated studies off of the radiologist’s work list, leaving him or her available for more complex exams.

But, according to Ortiz and his colleagues, radiology must be careful before proceeding down this path.

“If one year, we agreed upon a catalog of procedures to be relegated, do we really believe it will stop at those procedures deemed ‘simple’ by radiologists?” they asked. “Radiology, particularly interventional radiology, already finds itself in ever-growing struggles with other physicians for access to procedures, such as cardiac imaging or vascular interventions.”

Instead, in their editorial, they outlined their reasons why radiologists should lean more heavily on AI for support.

First, they pointed out that the push behind greater autonomy for NPPs is rooted in their ability to complete non-complex tasks, such as placing a nasogastric tube, successfully. However, radiology’s interpretation responsibilities are largely more complicated.

“The fallacy of this logic is highlighted by the idea that radiologists are not only responsible for answering the question at hand, but are responsible for the ‘whole image,’” they explained. “Although one could train an NPP to identify tips of lines, tubes, and otherwise, this does not rescind the liability for finding the unexpected.”

Even if radiology does cede control of simpler tasks to NPPs – but remains responsible for signing off on the work completed – the specialty runs the risk of creating a “culture of rubber-stamping” without review.

Second, the Center for Medicare & Medicaid Services recently granted its first approval to AI software, allowing for payment for the use of these tools. Consequently, many in the industry see this as an encouragement to additional AI vendors to continue development and clinical trials.

“Unlike humans with a narrow scope of practice, narrow AI algorithms can easily be integrated into existing workflow and amalgamated into a platform for use by radiologists,” the group said, noting there is little support for autonomously operating, unsupervised AI. “Many of the gains touted by proponents for the use of preserving the radiologist’s role, supplemented by AI.”

Ultimately, said Ortiz and his colleagues, expanding the use of NPPs will have unforeseen consequences for radiology’s future. Rather than opting to delegate radiology work to others, providers should be focused on strategies that can empower radiologists to stay in control of the imaging care that benefits patients.

“Empowered by AI,” the group said, “radiologists can achieve their wish of being as ubiquitous as water and remain heralded as diamonds.”

Industry experts advocate for radiologists to opt for relying on artificial intelligence – rather than non-physician providers – for help with workflow and cost reduction.

In a Choice Between AI and a Radiology Extender, Choose AI

A substantial international effort, bringing together experts from a variety of specialties, is now in motion with the goal of augmenting the use of MRI to better determine the long-term impacts of traumatic brain injury.

Dubbed ENIGMA, this initiative based at the University of Southern California and conducted in conjunction with the Norwegian University of Science and Technology (NTNU), is designed to collect, combine, and analyze large brain imaging data sets from around the world, searching for connections that cannot be identified on single studies.

The team shared the specifics of this initiative in 

“A major challenge in the research is to figure out which injury characteristics and which changes in the brain caused by the injury can predict how patients will recover and what follow-up they need,” said Alexander Olsen, Ph.D., associate professor of psychology and head of the Clinical Neuroscience Laboratory at NTNU. “A big part of the challenge is that individual patients are so different.”

The Value of MRI After Traumatic Brain Injury

Progress into understanding how the brain responds after a traumatic brain injury has been stymied, largely because most previous studies were small and they had no standard way for sharing and analyzing data across institutions because patient populations are heterogenous. The hope now, according to this group comprised of 170 researchers from 13 countries, is that investigations into newer and more advanced MRI methods will provide some clinical benefit.

“By pooling our resources, in terms of data, computational power and intellectual expertise,” said Emily Dennis, Ph.D., co-principal investigator for ENIGMA’s main group on brain injuries, “we’ll be able to tackle some of the big unanswered questions in our field, such as how sex impacts outcome, whether there are subtypes within the broader patient population, or how to handle lesions in neuroimaging data.”

While MRI images can reveal the size and type of injury, Olsen’s group will work with research-based MRI methods that use advanced algorithms and statistics. They intend to apply those methods to MRI data that has already been collected from investigators across the globe, including the United States, Europe, Australia, the Middle East, South Africa, and South America.

“We’re working to develop better and more standardized ways of summarizing and making sense of the MRI data.” Olsen said, noting that only an international collaboration can handle data of this magnitude. “We hope to contribute to breakthroughs in research that will benefit patients.”

Worldwide effort will amass large datasets from institutions  that can be used to identify long-term traumatic brain injury and augment therapies. 

Global MRI Initiative Looks to Improve Brain Injury Treatment

The radiation oncology (RO) payment model from the Centers for Medicare & Medicaid Services (CMS) has been pushed back from its original Jan. 1 start date.

In a statement released Thursday, Oct. 21, via Twitter, the CMS Administrator Seema Verma said the agency would postpone the payment model launch until July 2021. The decision was made based on the response from the RO community that indicated they needed more time to prepare.

The move earned gratitude from the RO community. The leadership of the American Society of Radiation Oncology published a comment, expressing their appreciation that CMS paid heed to their requests, joining the American College of Radiology in resisting the initial Jan. 1 start date. In particular, they said, COVID-19 has presented significant challenges to the specialist community.

“We are hopeful that the delay represents the first step toward full, open engagement with ASTRO on ways to ensure that the RO Model achieves our shared goals on higher quality, lower-cost cancer care,” said Theodore L. DeWeese M.D., the chair of ASTRO’s Board of Directors. “We remain seriously concerned with excessive payment cuts in the model that will cause significant financial strain on practices and risk patient access to radiation treatments.”

Once implemented, the RO model will bundle payments for a 90-day episode-of-care to radiotherapy provides who treat patients with one of 16 different types of cancers. Over five years, the anticipation is that it will save approximately $230 million.

CMS pushes launch from January 2021 to July 2021.



Radiation Oncology Payment Model Start Date Delayed

’s Weekly Scan. I’m senior editor, Whitney Palmer.

Before we get to our featured interview with Drs. Rich Heller and Nina Kottler from Radiology Partners about corporatization in radiology practices, here are the top stories of the week.

Think back for a moment to being a medical student – what one tool was always at your side. No doubt, you immediately thought of your stethoscope. Well, there’s a potential paradigm shift underway in medical education that could have point-of-care ultrasound taking over that coveted spot. Together in partnership, ultrasound manufacturer Vave Health and the College of Osteopathic Medicine at Touro University in Nevada have launched a new ultrasound curriculum that weaves image acquisition and interpretation instruction into nearly all levels of didactic training. At the same time students will be learning about anatomy and disease presentation, they will also be using hand-held ultrasound probes for visualization. In addition, students are getting a Vave EduPlus Membership that will give them access not only to ultrasound experts, but also to in-app content that can both help them prepare for medical exams and provide clinical context. The goal, according to Vave Health leaders, is to make the program available to other institutions who can then customize the curriculum to meet their program needs.

Throughout this year, there has been a lot of news emerging around pre-operative MRI and in what situations and for which women it works best. In an multi-institutional study published in 

investigators determined that this scan performs best in women who have dense breasts who have undergone digital breast tomosynthesis rather than digital mammography alone. In these situations, pre-operative MRI is able to identify more overlooked malignant lesions. To make this determination, researchers conducted a retrospective study of 388 consecutive breast MRIs captured for newly diagnosed breast cancers between Oct. 1, 2013, to July 31, 2015. Based on their results, the team discovered MRI detected additional malignant lesions in 57 percent of all women with dense breasts included in their study. Specifically, pre-operative MRI identified 50 additional malignancies, more of which were in women with dense breasts who had undergone digital breast tomosynthesis. These findings are clinically important, the researchers pointed out, because 43 percent of women in the United States between the ages of 40 and 74 have dense breasts, and evidence continues to mount that they could benefit from supplemental screening.

Since the beginning of the pandemic, the American College of Radiology and other industry professional organizations have recommended against using CT to diagnose COVID-19. But, research published by a team of France this week in the 

showed that spectral CT with electron density imaging can make it easier for providers to assess the extent of lung lesions in patients who have early-stage disease. The team used a small group of four case studies from patients diagnosed and treated in their hospital to show that electron density imaging improves the visualization of ground-glass opacities compared to conventional CT scans. The team reconstructed the spectral CT images using the same standard soft kernel (filter B) and a similar iterative method that is used to capture conventional CT images. Then, they compared initial conventional CT images with follow-up scans. They found that all 45 ground-glass opacities identified in the four patients showed up better on the electron density imaging, and the lesion extent was much easier to determine. Overall, they said, these results show that it is possible to gather greater detail for earlier assessment of ground-glass opacities, potentially impacting treatment for COVID-19.

 spoke with Drs. Rich Heller and Nina Kottler from Radiology Partners about the growing trend of corporatization in the industry. They shared with us not only their experiences within Radiology Partners, but the impact that corporatization is having on radiology at the local level and as a specialty overall. Here’s what they had to say.

Videos

Ultrasound as the New Stethoscope; Pre-Operative MRI and Dense Breasts; Spectral CT and COVID-19; Corporatization in Radiology

Diagnostic Imaging's Weekly Scan: Oct. 23, 2020

Protecting ultrasound providers during the COVID-19 pandemic requires going a step further than simply disinfecting surfaces – the air in ultrasound departments should be disinfected, too.

That’s the recommendation from a group of ultrasound experts from China. Representatives from four medical organizations collaborated this year to produce the first recommendation about air sanitation during the outbreak. They published their guidance in the Oct. 12 

“Given that patients undergoing ultrasound examination might be virus carrying or infected, or suspicious for infection (symptomatic or asymptomatic), it is of great importance to have good protection for the healthcare staff (including doctors, nurses, medical assistants, and technicians) during work,” said the team led by Luo Yukun, Ph.D., professor in the diagnostic ultrasound department at Chinese People’s Liberation Army General Hospital in Beijing. “Since in the department of ultrasound the healthcare workers are close contacted with patients who might be infected or virus carrying, it is extremely important to offer protection to them.”

This new advice underscores how what the industry knows about the COVID-19 virus continues to grow and change.

Lung Ultrasound Reveals COVID-19 Duration and Disease Severity

The team divided their suggestions into two main categories – designated spaces for healthcare providers and patients and personal protective equipment (PPE). They based their recommendations on existing hygiene standards, practitioner experience, and existing literature.

Most importantly, the team said departments must designate certain individual areas to be strictly used by patients or providers. For example, they said, each group should be relegated to separate hallways. In addition, some areas should be off-limits except to providers, and departments should create two buffer zones where providers can put on and take off PPE.

Following these measures is critical, they said because it will help keep track of what resources have been used and contaminated and strengthen the efforts to minimize exposure and transmission. The team also recommends disinfecting all surfaces, such as door handles, keyboards, floors, and ultrasound probes and machines. Using probe and plastic machine covers when it is feasible – especially with patients suspected of infection – could also be beneficial.

The team also offered clarity around the recommendations for greater air disinfection. Rooms reserved for patients without known or suspected COVID-19 infection should be ventilated for at least 30 minutes in both the morning and evening, and ultraviolet light should be added after all patients have been seen for the day, as well.

However, rooms used for patients who are suspected of infection must undergo a more stringent protocol. Alongside the daily ventilation measures, the team also said departments should also use a 3-percent hydrogen peroxide spray or a UV lamp for 60 minutes after each patient. Putting a plasma air disinfection machine in the COVID-19 rooms could also help combat exposure and transmission.

In addition, the authors reiterated existing PPE guidelines, advocating that everyone in the department – not just providers working directly with the ultrasound equipment – wear work coats, latex gloves, surgical masks, and disposable hairnets. These PPE should be changed every 4-to-6 hours, they said. But, they went a step further, recommending that providers wear isolation gowns with patients who have known infection and full-face respirators and other tertiary PPE for the riskiest procedures, ultrasound-guided aerosol-generating procedures.

To dispose of or process this equipment, the team offered this guidance:

Dispose of medical waste items in dedicated trash cans.

Soak anti-fog goggles in electrolyzed-oxidizing disinfectant for 5 minutes or chlorine-containing 1,000 mg/L disinfectant for 30 minutes.

Wipe face shield with 75-percent medical alcohol.

Change working coat every day or put under UV light in dressing room for 30 minutes.

Disinfect work shoes with UV light when necessary.

Despite not being a popular screening method in China, the team said, handheld ultrasound has proven beneficial with COVID-19 patients in other countries in a variety of healthcare settings.

“Ultrasound examination, having the advantages of convenience, quickness, non-invasiveness, radiation free, bedside available,” they said, “is a cost-effective, real-time technique which was reported to be an important role in the diagnosis and treatment of COVID-19.”

Researchers from China recommend disinfecting the air, alongside, sanitizing surfaces, to reduce exposures and transmission.



Don’t Stop with Disinfecting Surfaces – Clean the Air to Decrease COVID-19

Contrary to conventional belief, MRI exams can be performed safely in patients who have non-MR compatible cardiac devices, including patients who are pacemaker-dependent or who have abandoned leads.

More than 2 million patients have cardiovascular implantable electronic devices (CIEDs), such as pacemakers and implantable cardioverter defibrillators (ICDs), and they are a patient group who most often could benefit clinically from having an MRI exam. Until now, though, providers have been forced to choose between finding an alternative, less-effective imaging for the chest or removing a necessary cardiac device.

a multi-institutional team of investigators has outlined it is, in fact, safe to conduct an MRI with these patients – and it can be done without a negative outcome.

“We found no serious adverse consequences of performing MRI examinations, including cardiac MRI examinations, in a large consecutive cohort of patients with non-MRI-conditional CIEDs,” said the team led by Sanjaya K. Gupta, M.D., a cardiologist with Saint Luke’s Mid America Heart Institute in Kansas City, Missouri.

3 Tips to Improve MR Safety with Implants and D

Previous studies have shown MRIs can be safely conducted in patients with non-MR conditional devices, but this study goes further to include patients whose hearts will stop beating if their defibrillator ceases to work, as well as those who have abandoned or fractured wires that are no longer connected to their heart.

While many CIEDs have been deemed safe for MRI imaging by the U.S. Food & Drug Administration, pacemakers and ICDs have fallen outside this category. This study opens the door for more imaging options, Gupta said.

“While all devices implanted in patients today are MRI compatible, millions of people worldwide, including many young people, have older devices considered not compatible,” he said. “It’s unfair to tell these people that they can’t get an MRI for the rest of their lives.”

In fact, he added, the impetus behind this study was a patient with a brain tumor who was unable to undergo MRI exams that were critically needed during her treatment because her pacemaker was not MR conditional. Due to the lack of scans, the patient were forced to undergo several risky surgical procedures, he said.

Consequently, to better understand the risks posed by MRI to these patients, Gupta’s team created the Patient Registry of Magnetic Resonance Imaging in Non-Approved Devices (PROMeNADe) that included 532 patients who underwent 608 MRI exams, including 61 cardiac MRIs between September 2015 and June 2019. Participants in this study included individuals from groups that had not been incorporated into previous studies.

Notably, the team said, their registry is the largest series of MRI exams collected in patients with pacemaker-dependent ICDs, the second largest for patients with abandoned or fractured leads, and the third largest in non-compatible devices.

Of the participant group, 36 percent were referred for an MRI by a neurologist, and 20 percent were referred by a cardiologist. In particular, 161 exams (26 percent) were conducted on pacemaker-dependent patients – 43 were defibrillator, 14 were dual-chamber ICDs, and 29 were cardiac resynchronization therapy defibrillators. These devices were manufactured by Medtronic, Abbott/St. Jude Medical, and Boston Scientific. The remaining patients had pacemakers and CRT pacemakers.

Throughout the study, not only did a nurse closely monitor each patient’s vital signs during their time in the scanner, but the team also evaluated every device both before and after the MRI. Pacemaker-dependent patients had their devices turned to asynchronous mode before entering the scanner, and tachycardia therapies were disabled in ICD patients during the MRI.

The team also followed up with the patients after six months post-MRI. According to their results, MRIs – including chest MRIs – are safe to conduct in pacemaker-dependent ICD patients, as well as those who have non-MR conditional devices or abandoned leads.

“There were no adverse events,” Gupta said, noting that 14 percent of patients had multiple MRI exams. “The protocol worked amazingly well. We had no issues with any of the patients and no harm to the devices.”

Alongside being safe to perform, the team determined these exams also had a clinical impact that altered patient care. Based on a survey conducted with 150 of the referring physicians, the outcomes of the MRI exams for both patients undergoing cardiac and non-cardiac MRIs changed a suspected diagnosis 25 percent of the time and the suspected prognosis in 26 percent of participants. In addition, the scans led to different medical or surgical treatment plans 42 percent of the time.

The team did note their study had some limitations. It was not able to determine the safety of MRI studies in patients who had their devices implanted within six weeks of the scan. They also did not examine hemodynamically unstable patients, patients who required recent defibrillator therapy, or patients for whom the referring clinician felt it unwise to turn off arrhythmia detection during the scan.

Still, they said, these results could open the door for more people who could benefit from these studies to undergo them without fear of safety risks.

“We’re hopeful that our work will add support to expand the FDA’s indications for devices that are considered MRI-compatible,” Gupta said. “A lot of work went into this study, but it’s worth it when you consider all the lives impacted.”

Study shows MRI exams can be safely performed with no adverse events in patients who have non-MR compatible devices, making the exams available for patients who frequently needs these studies the most.

MRI Is Safe for Pacemaker Patients, Opening the Door for Needed Exams

A recently published study from the United Kingdom (UK) confirms that mammography screening, beginning at age 40, significantly reduces breast cancer mortality. The results appeared in 

 in August 2020. These study results reaffirm the recommendations of the American College of Radiology and the Society of Breast Imaging. Both organizations recommend that most women begin annual mammography at age 40 – earlier than when most women have their first screening.

What does this UK study mean to us here in the United States?

The UK study provides valuable additional data for those of us in the breast imaging field. This recent update confirms, again, that annual breast cancer screening beginning at age 40 saves lives. Breast cancer death rates were reduced by approximately 25 percent for women who began screening at age 40, averting one death per 1,000 women screened, and this absolute gain remained constant until the end of the study. The UK study also confirmed that there is little fear of over-diagnosis in the 40-to-49 age category with a rate similar to what is commonly encountered in women over 50.

The UK Breast Screening Age Trial recruited 53,883 women to begin annual mammography screenings at age 40. Researchers placed twice as many women (106,953) in the control group. The control group participated in the UK’s National Health Service (NHS) standard breast cancer screening. The NHS provides breast cancer screenings to women aged 50 until age 71 every three years.

Women Who Survive Childhood Cancer Benefit From Earlier Breast Screening

Researchers sent randomly selected women invitations through the mail, offering annual breast cancer screening beginning at age 40. These women were recruited from general practitioners’ lists, held by Family Health Services Authorities. The women who responded were ages 39-to-41, from 23 breast screening sections in England, Scotland, and Wales.

Researchers also randomly chose women for the control group. These women were not aware of the research project and received the standard breast cancer screening with no departure from standard care.

The younger annual mammogram group received annual mammograms until they received their invitation from NHS for breast screening. The control group of women began their breast cancer screenings once they reached age 50, following NHS recommendations.

Recruitment began on October 14, 1990, and ended on September 24, 1997. Researchers followed patients for a median time of 22.8 years.

The trial used two-view film (analog) mammography for each participant’s first screening. Afterward, single view was utilized. The local facility staff double-read each participant’s mammogram. If a woman moved, she could self-refer to the nearest center taking part in the trial. Women in the trial transitioned to the regular NHS breast cancer screening program once they received their invitation around age 50.

The NHS Central Register and all trialists were notified of every breast cancer diagnosis, breast cancer death, and other death causes for trial members through February 28, 2017.

The primary endpoint for the UK Breast Screening Age Trial was death by breast cancer in both groups. Researchers compared deaths from both groups that occurred before their invitation to the standard NHS breast screening program.

Participation from screening invitations was similar in both groups of women:

68.1 percent (36,622 women out of 53,801 women invited in the interventional group) had their first mammogram.

69.1 percent (176,746 women, out of 255,618 women invited in the control group) had their first mammogram.

False-positive results in the interventional group were modest. Researchers saw a 4.9 percent false-positive rate for participants’ first screen mammogram, and a 3.2 percent false-positive rate occurred for later screenings in the interventional group. Breast cancer incidence rates between the interventional group and the control group showed similar incidence rates.

Researchers saw a significant difference in death rates from breast cancer by 10 years. The interventional group experienced just 83 deaths compared to 219 deaths in the control group. There was no significant difference during the next 10-plus years of follow-up. Of the breast cancer deaths, 126 occurred in the early intervention study group and 255 in the control group.

The newest study update comes 23 years after recruitment ended. The study confirms that annual breast cancer screenings that begin at age 40 reduce breast cancer mortality.

In summary, the UK study confirms that screening mammography beginning at age 40 significantly reduces breast cancer mortality as compared to women who wait to begin screening mammography until age 50. These findings validate both the ACR and the SBI recommendations that women of average risk begin having annual mammograms beginning at age 40.

“Breast cancer screening saves lives, annual screening mammography beginning at age 40 saves the most lives.”

Daniel Shekleton, M.D., is a breast imaging radiologist and breast intervention specialist with Raleigh Radiology. He is a member of the RSNA, ACR, and SBI. He earned his bachelor’s degree at the U.S. Military Academy at West Point and completed his medical degree and residency in radiology and internal medicine at the Southern Illinois University School of Medicine. He joined Raleigh Radiology in 2019.

Screening mammography begins to reduce breast cancer mortality at an age earlier than when most women begin screening.

UK Study: Benefits of Breast Cancer Screening Begins at 40

A new mapping tool used with MRI can help radiologists pick up on the early signs of dementia with more than 70 percent accuracy, a new study has revealed.

Currently, providers rely on a “trained eye” to distinguish white matter lesions – hyperintensities – that can point to the beginning stages of cognitive decline. But, in an article published Oct. 27 in 

a team of investigators from New York University (NYU) Grossman School of Medicine share the results of their new tool that can analyze tissue damage seen on MRI brain scans.

“Our new calculator for properly sizing white matter hyperintensities, which we call bilateral distancing, offers radiologists and other clinicians an additional standardized test for assessing these lesions in the brain, well before severe dementia or stroke damage,” said study senior investigator Yulin Ge, M.D. professor of radiology at NYU Langone.

Patients who have more and larger white matter lesions on the gray matter of their brain are more likely to experience memory loss and emotional problems, especially as they get older, the team said. If these spots appear at the center of the brain, they can also indicate worsening dementia or other conditions, such as stroke or depression, that can damage the brain.

Instead of relying on the existing three-point scale method where providers use their best judgement to stage disease, this team set out to create a more standardized, objective method that could accurately measure lesion volume and location. Providers can access the tool 

To do so, they randomly selected 72 MRI scans from the Alzheimer’s Disease Neuroimaging Initiative. Most patients were over age 70, and an equal number of men and women were included. Their cognitive abilities ranged from normal brain function to mild cognitive decline to severe dementia.

Once the brain was mapped with the most up-to-date MRI techniques, the team applied computer software to calculate the exact location and volume, in liters, for all white matter lesions that could be seen. They determined a lesion’s volume based on its distance from both side surfaces of the brain with normal ranges between 0 milliliters, indicating no lesions seen, and 60 milliliters, referring to some lesions. Any volume over 100 milliliters, they said, indicated severe disease.

Based on their calculations, which they crossed-checked, the team determined that 7 out of 10 – roughly 70 percent – of their measurements matched with the patient’s actual diagnosis.

Employing this tracking tool can be useful clinically, said study lead investigator Jingyun “Josh” Chen, Ph.D., research assistant professor of neurology at NYU Langone. With a tracking and measurement tool that is standardized, clinicians will be able to monitor whether – and how – white matter lesions grow in a patient’s brain relative to other tau and beta-amyloid proteins that are believed to be involved in the development of dementia and Alzheimer’s disease.

But, providers should proceed with caution, he noted. White matter lesion measurements are not enough on their own to validate an early dementia diagnosis. Providers should still take other factors, such as a history of brain injury, memory loss, and hypertension, into consideration as they are verified features of cognitive decline or other brain and blood vessel diseases.

Work with this tool is still ongoing, the team said. They are now testing it further with an additional 1,495 brain scans that will include a more diverse patient population.

A tool that objectively measures the volume of white matter lesions can accurately pinpoint evidence of early dementia.

New Tool Used with MRI Better Detects White Matter Lesions

Cardiac ultrasound can reveal how COVID-19 damages the heart, not only potentially helping doctors identify patients who are at risk faster, but also guiding future therapies.

Journal of the American College of Cardiology, 

investigators from the Icahn School of Medicine and Mount Sinai Hospital revealed that cardiac ultrasound (echocardiograms) can identify different types of post-cardiac injury structural damage that can occur in COVID-19 patients. These injuries can be linked to several deadly conditions associated with higher mortality risks in hospitalized patients, such as heart attack, pulmonary embolism, heart failure, and myocarditis.

“Early detection of structural abnormalities may dictate more appropriate treatments, including anti-coagulation and other approaches for hospitalized and post-hospitalized patients,” said study author Valentin Fuster, M.D., Ph.D., director of Mount Sinai Heart and physician-in-chief of The Mount Sinai Hospital.”

Echocardiograms are particularly suited for providing this type of information, the team said, because it is the only modality that can be safely used at the beside for patients who are on ventilators.

This new retrospective study, the team said, builds on Mount Sinai’s existing body of research into troponin levels that shows heart damage is common in COVID-19 hospitalized patients. This investigation focuses on elevated cardiac troponin levels that are present alongside echocardiographic abnormalities. Based on their analysis, the team determined this combination was linked to a worse prognosis and mortality for the patient than having an elevated troponin level by itself.

“We found that among COVID-19 patients who underwent transthoracic echocardiography, these cardiac structural abnormalities were diverse and present in nearly two-thirds of patients,” said first and corresponding author Gennaro Giustino, M.D, cardiology fellow at The Mount Sinai Hospital, noting this is one of the first studies to generate detailed echocardiographic and electrocardiographic data in hospitalized COVID-19 patients who have lab evidence of myocardial injury.

To gather this data, the team analyzed transthoracic echocardiographic (TTE) and electrocardiographic (ECG) scans from 305 adult, COVID-19-positive patients who were admitted to four New York City hospitals in the Mount Sinai system, as well as one hospital in Queens and two hospitals in Milan, Italy, between March 2020 and May 2020. The average patient age was 63, and 67.2 percent of participants were men.

Evidence of myocardial injury was present in 190 individuals – 62.6 percent of the study population. Heart damage was present in 118 of them when they were admitted to the hospital, and 72 developed a myocardial injury during their hospitalization. Those patients with injuries had more electrocardiographic abnormalities, higher inflammatory biomarkers, and an increased prevalence of TTE abnormalities than patients without heart injury.

According to their analysis, the identified abnormalities were diverse, and some patients had multiple abnormalities. For example, 26.3 percent had right ventricular dysfunction, an abnormality that can be linked to pulmonary embolism and severe respiratory failure, and 23.7 percent had regional left ventricular wall motion abnormalities that can be associated with heart attacks. In addition, diffuse left ventricular dysfunction – an abnormality associated with heart failure and myocarditis – was present in 18.4 percent, and 13.2 percent of patients had grade II or III diastolic dysfunction, a condition that can lead to stiffer cardiac chambers. Lastly, 7.2 percent had pericardial effusions that can cause abnormal heart pumping.

The team also went further to examine in-hospital morality and troponin elevation, adjusting for major COVID-19 complications, including shock, acute respiratory distress syndrome, and renal failure. Their findings revealed troponin elevation was 5.2 percent in patients without heart injury and 18.6 percent in whose who did have myocardial injury without echocardiographic abnormalities. The elevation was 31.7 percent in patients with heart injury and echocardiographic abnormalities.

Overall, the team said, cardiac ultrasound can play a significant role in managing COVID-19 patients and determining their course of treatment.

“Our study shows that an echocardiogram performed with appropriate personal protection considerations is a useful and important tool in early identification of patients at greater risk for COVID-19 related cardiac injury, who may benefit from a more aggressive therapeutic approach earlier in their hospitalization,” said Martin Goldman, M.D., cardiology professor at Ichan. “Additionally, because this is a new disease with lingering symptoms, we plan on following these patients closely using imaging to evaluate the evolution and, hopefully, resolution of these cardiac issues.”

The modality is the only one that can be safely conducted at the bedside with patients on a ventilator.

Ultrasound Reveals Cardiac Injury Caused By COVID-19

It was one of those workweeks: I spent much of each day behind the 8-ball.

That metaphor will mean different things to different rads. Heck, it has meant different things to me over the course of the four jobs I’ve held since finishing fellowship.

First was in a group of outpatient imaging centers which routinely maintained a backlog of unread cases in each location. Freshly graduated from hospitals where all the work got done each day, I could see that this was a very different mess. Attempting to get everything done here would be tilting at windmills. But, that didn’t stop me from striving to make a visible dent as I tried to prove myself to the practice.

At some point, the practice rotated me to one of its saner locations, where I was actually able to get everything done and up-to-date. This was noticed – one of the other rads was also young and hard-working, and the group responded by exclusively assigning one or the other of us to that office. It was only for half a day at a time, though, so we wouldn’t be able to 

When a self-imposed expectation of productivity is a driving force.

New Tool Used with MRI Better Detects White Matter Lesions

Ultrasound Reveals Cardiac Injury Caused By COVID-19

Behind the 8-Ball