By Matt Skoufalos
Mammography is the oldest and most widely available imaging modality for breast cancer detection. Developed by French engineers Jean Bens and Emile Gabbay, it emerged in the 1960s as the “senographe,” a low-dose X-ray technology for the imaging of breast tissue. Mammography is particularly effective for patients aged 50 to 69, according to the National Cancer Institute (NCI), but it’s also historically been difficult to overcome the knocks against it.
For a start, the examination, while valuable to physicians for identifying tissue abnormalities, is physically uncomfortable. Mammograms are administered via paddle compression of the breast, which more uniformly distributes its tissue for study. But patients frequently report discomfort with the procedure for a variety of reasons, from its interaction with their personal physiology to psychological anxiety around the entire experience of being scanned.
Furthermore, at least 10 percent of women tested will receive a false-positive exam result; that figure climbs to 50 percent of all women among those who complete annual screenings for a decade. A smaller subset (seven to 17 percent) will even undergo tissue biopsies unnecessarily. Additionally, mammography can fail to detect invasive breast cancer in six to 46 percent of exams, particularly “rapidly growing interval tumors,” which can emerge between regular mammograms, and in women with dense breast tissue, according to the NCI.
As such, although early cancer detection can save lives, mammograms are on the decline in the United States. In 2007, the journal Cancer noted that, by the year 2000, some 70 percent of American women had reported having undergone a mammogram within two years of being surveyed. By 2005, that number was falling, and in 2009, the U.S. Preventative Services Task Force (USPSTF) modified its screening guidance to stipulate that mammograms are most useful for women aged 50 to 74, and then only every other year. That contradicted the historical position of the American College of Radiology (ACR) that annual mammograms should be routine for women aged 40 and older; in 2015, the American Cancer Society seemingly split the difference, recommending annual screenings for women aged 45 to 54, and biennial mammograms thereafter.
Despite the conflicting recommendations around mammograms, their utilization rates, and the subsequent, myriad implications for breast cancer screenings overall, medical device manufacturers have pressed on with technological solutions for improving the accuracy of imaging studies. One of them is the Senographe Pristina, a mammography system introduced by GE Healthcare in 2017. The company touts its women-led design team as having driven critical ergonomic improvements to the traditional mammography system that increase patient comfort, thereby improving the quality of studies conducted, and possibly mitigating the number of false positives and examinations deferred.
“While there are multiple factors impacting a woman’s choice to get screened regularly, improving the patient experience is one factor where we can make a difference,” said Agnes Berzsenyi, president and CEO of GE Healthcare Women’s Health.
Senographe Pristina features a number of structural improvements over legacy mammography systems. These include a bucky (breast platform) with rounded corners, as sharp-edged trays on earlier devices could uncomfortably poke patients’ ribs and armpits; and a thinner image detector “that requires less hard, cold material touching the patient,” Berzsenyi said. Its biggest ergonomic innovation may be the replacement of traditional handgrips with arm and headrests. As studies are conducted with women facing the machine, the arm and head rests allow them to relax their muscles during the exam, which Berzsenyi said helps improve image quality as well as patient comfort.
GE Healthcare also developed the Pristina Dueta wireless remote, which enables “patient-assisted compression” during a mammogram. In short, the patient is allowed to dial in the intensity of breast compression with the help of a technologist. Berzsenyi said this feature helps to mitigate patient discomfort, as does installing the device within a sensory suite designed to reduce patient anxiety with targeted “scent, sight and sound” stimuli. She cites a 315-patient satisfaction survey in which a majority of women scanned with the Senographe Pristina at two European imaging sites said they had a better, more comfortable experience with the device as compared with traditional mammography systems. More than half the women scanned were offered use of the Dueta remote, and 80 percent of those said they found it made the scan more comfortable.
“By improving the patient experience, we hope to help health care providers get more patients screened regularly,” Berzsenyi said. “Comfort is key to patients, and therefore clinicians see features like Pristina Dueta as an important offering to improve their patients’ experience and increase their patients’ adherence to regular screenings.”
In addition to improving patient comfort and experience during a breast imaging study, Pam Cumming, director of product marketing for Women’s Health at Siemens Healthineers North America, said advances in digital breast tomosynthesis could eventually push that technology toward becoming the standard of care.
“The purpose of mammography is to perceive subtle change that could be a sign of cancer,” Cumming said. “Tomosynthesis really allows radiologists to move through the breast in a 3D way. Regardless of skill level or experience, every single radiologist improves with the addition of 3D.”
Siemens Healthineers MAMMOMAT Revelation digital breast tomosynthesis system works to capture the breast in “a wider sweep” during imaging, which Cumming said offers physicians up to three times better depth of resolution, which helps to eliminate overlapping tissue, making small cancers easier to find. And like GE Healthcare, Siemens Healthineers is working to improve scanning rates by increasing the patient comfort of its technologies, including adding mood lighting on the gantry and housing the device in a room with lower lighting to create an atmosphere of calm.
“When a woman walks into a room that’s semi-darkened and sees this nice lighting, it takes the edge off, and allows the technologist to better position her more easily, and this is key to image quality,” Cumming said.
Just as the GE Pristina Dueta offers patients the chance to help set the compression level of their studies, the MAMMOMAT Revelation has similar, comfort-focused features like OpComp, which helps determine how much breast compression is required. That pre-pulse also contributes to the radiation dose calculation, which allows for more precise tuning of the device, which means that each woman receives the correct dose for her anatomy.
“Anatomy is not always perfectly balanced, and a dose is calculated on the pre-pulse instead of on a standardized table,” Cumming said. “It adapts to her anatomy.”
Clinical investigations into the effectiveness of different breast imaging modalities are also shedding new light on prior approaches to mammography. Cumming cited the results of a two-year, Siemens-sponsored, digital breast tomosynthesis (DBT) screening trial involving 7,500 women in Malmö, Sweden. Completed as the first half of a planned, 15,000-patient study, it compared one-view DBT and two-view digital mammography (DM) via double-blind reading and arbitration to see if DBT could function as well as DM as a standalone modality for the detection of breast cancer. The study concluded that DBT was faster, more reliable, and more comfortable than DM in a head-to-head comparison.
“On top of the cancer detection rate, they found out they could do 50 percent less [breast] compression” and not compromise cancer detection, Cumming said. “Less discomfort could increase compliance.”
“In a screening population, most women will not have cancer,” she said. “So we need to make sure the basis of the technology is sound and strong. When it was 2D in the days of film, you exposed the tissue and got a piece of film. Now, you gather digital to create the 3D volume and that information can be manipulated and enhanced, so we can see more detail and hopefully not lose any of those tiny subtleties that might be cancer.”
In addition to technological advances, everyone in health care follows the impact of policymaking on the future of the imaging business. Whether it’s laws that notify dense-breasted patients that a mammogram may not necessarily detect cancer in their tissue (34 states have such laws in place, with bills in the works in five others) or regulations that help improve patient access to examinations, equipment manufacturers have their fingers on the pulse of legislative work and advocacy that shapes the marketplace.
“We realize that ensuring all women have access to those solutions is critical,” said Tracy Accardi, global vice president of research and development, breast and skeletal health solutions for Hologic.
“Insurance coverage is a key factor influencing patients’ access to breast cancer screenings, which is why Hologic is dedicated to opening access,” Accardi said. “We also believe that patient education plays a huge role in breast health, which is why we’re committed to educating women about critical mammography screening services not just during breast cancer awareness month, but throughout the year, so they can become their own health advocates and make informed decisions about their breast health.”
Accardi traces “strong headway” with private and government insurance payers to driving greater access to DBT via modalities like Hologic’s Genius 3D Mammography exam, which she said is the only mammogram to be FDA-approved as superior for routine breast cancer screening of dense-breasted women. But she also touts the value of machine-learning-powered software and high-tech algorithms in detecting abnormalities in imaging studies.
“I think we’ll continue to see a much greater focus being placed on breast density assessments, as each woman’s breast tissue is unique, and breast density impacts how difficult it is for radiologists to detect suspicious lesions on certain screening technology,” Accardi said. “It’s not just about bringing breast screening solutions to market, but more importantly, ensuring women across the globe are able to benefit from our technologies and lead healthier lives.”
Berzsenyi said that GE Healthcare supports state breast-density notification laws, and would support a federal notification law as well; however, those kinds of laws should be paired with coverage for additional imaging services to make sure that they are most effective in achieving their aims.
“It’s important for women to know their breast density and that there are other technologies out there,” Berzsenyi said. “But it’s also important that secondary screening technologies such as ultrasound and MR are covered.”
“Just because they are in the community doesn’t mean that all women have access,” she said.
When access is a priority, Cumming said that vendors can work with their customers to help improve screening rates. She pointed to a case study that Siemens Healthineers did with McCurtin Memorial Hospital in Idabel, Oklahoma, a remote area of the state that has one of the highest breast cancer death rates in the country. In partnership with the Susan G. Komen Foundation, the 99-bed, rural hospital purchased a Siemens MAMMOMAT system, and has begun seeing increases in patient volumes such that it can now provide access to advanced breast imaging services.
“Access is a huge passion of mine,” Cumming said. “We know that there are definitely areas that are underserved. Where can we bring care? Perspective is critical and helps us guide and formulate our passion for what we believe: the best medicine for the right patient at the right time.”
Finally, Siemens Healthineers Technical Support Engineer Michael Figg points out that breast cancer awareness month often leads to an uptick in patient volumes, making proactive equipment assessments even more critical than usual. Figg suggests that service technicians connect with users to address any known issues ahead of time. Leaning on established interdepartmental relationships can allow clear, open feedback about clinical needs or equipment concerns, and can smooth any potential problems that may arise.
In addition to routine checks, Figg recommends that engineers specifically “examine breast paddles for any scratches or cracks, check system motion for smooth and precise movement, and make sure the acquisition systems have plenty of storage space.”
“From a service perspective, the most important part of being prepared is to be aware of any issues and resolve them quickly,” he said. “Minimizing delays and possible equipment failures is critical at this time, and being aware and prepared will ensure that breast imaging facilities provide the highest level of patient care.”