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Mammography has been proven to save lives by finding cancers when they are small enough to treat – but can we do better? Can we reduce the cancers that might be missed due to dense breast tissue1?

Because a “normal” mammogram may not reliably exclude cancer in women with dense breasts; and women with extremely dense breasts have the highest risk of developing cancer2,3, it is incumbent on the radiology community and referring physicians to work together to improve strategies and apply tools for managing patients with dense breasts.
Strong evidence supports supplemental screening
Over 70% of cancers occur in dense breasts4, and the limitations of mammography to image dense breasts is well documented5.

Many large-scale studies demonstrate strong evidence to support adjunctive imaging for dense breasts. Trials involving more than 100,000 women with dense breasts using supplemental screening ultrasound show added detection of 3-4 cancers per 1,000 women screened. Importantly, more than 85% of cancers found with screening ultrasound are node-negative invasive cancers6.

While most studies used handheld ultrasound (HHUS), recent research has evaluated the performance of automated breast ultrasound (3D ABUS) to increase cancer detection in women with dense breasts. The EASY Study (European Asymptomatic Screening Study), published in European Journal of Radiology, shows that it is feasible to implement 3D ABUS into a high-volume mammography center and increase the cancer detection rate while maintaining a low recall rate well within the recommendations of the European guidelines for quality assurance in breast cancer screening and diagnosis7. This is very consistent with the results of the SomoInsight Study by Brem et al., published in Radiology, and the reader performance studies by Skaane et al., published in Acta Radiologica, and Giger et al., published in the American Journal of Roentgenology. All three studies concluded that adding 3D ABUS to mammography improved the performance of mammographic interpretation.

A new 2017 study by Dr. Athina Vourtsis and Dr. Aspasia Kachulis, published in European Radiology entitled “The performance of 3D ABUS versus HHUS in the visualization and BI-RADS characterization of breast lesions in a large cohort of 1,886 women,” compared the utility of handheld ultrasound to 3D ABUS. HHUS exams were performed by radiologists and 3D exams by technologists. The results show that 3D ABUS yielded comparable results as HHUS in the detection and characterization of breast lesions, and in some patients proved to be superior to HHUS, especially in the detection of architectural distortions identified in the coronal reconstruction plane – a finding highly suspicious for malignancy8.

“In three of our patients, an architectural distortion was visualized on the coronal plane which was the only sign of an invasive lobular carcinoma and two radial scars which were not recognized in mammography or HHUS. Indeed, the coronal plane offers a new diagnostic advantage that cannot be obtained with traditional ultrasound,” said Dr. Athina Vourtsis.

“According to the literature the cancers we are finding in very dense breast tissue using automated breast ultrasound are under a centimeter, node negative, and very aggressive. These usually cannot be detected by mammography alone in the dense breast. These tumors are more easily detectable with adjunct technology such as automated ultrasound or much more expensive MRI when the mammogram is negative and the patient is still asymptomatic. Finding these cancers when small has a huge impact on patient treatment and mortality,” said Dr. Stuart Souders.
Successful implementation of 3D ABUS
The goal of any breast screening program is to find cancers early and reduce false positives. Adding 3D ABUS to screening mammography has shown a significant increase in invasive cancer detection with a nominal insignificant decrease in specificity9.

Success with 3D ABUS
Imaging for Women (IFW), located in Kansas City, Missouri, prides itself in offering the latest technology to provide patient care. In May 2014, IFW installed 3D ABUS to offer screening breast ultrasound for women with dense breasts. After the Missouri density inform law passed in 2015, IFW experienced increased demand for supplemental screening.

Upgrading to the Invenia ABUS in August 2015, IFW initiated a clinical study to document the impact of supplemental 3D ABUS on clinical and operational outcomes. During the study, nearly 42,000 women underwent mammography screening. Of which, 49 percent were determined to have heterogeneously or extremely dense breasts. More than 4,300 dense breast patients received a 3D ABUS exam, with more than 32 percent of these women receiving the exam on the same day as their mammogram.

Results showed an added cancer detection rate of 2.6 per 1,000 screened women (11 of 4,270). These cancers were all mammographically occult. The majority of the cancers detected with 3D ABUS at IFW were node negative with lesions ranging in size from 0.2 cm to 1.9 cm. The cancer yield of supplemental screening in this retrospective study was consistent with results seen in other real-world settings and even clinical reader trial settings.

New revenue stream
The IFW study also showed positive operational benefits in the form of added revenue. The addition of 3D ABUS increased breast ultrasound revenue by 61 percent. With a payer mix of 85 percent commercial and 15 percent Medicare, the average 3D ABUS reimbursement across all payers was $202.84 for a bilateral exam and $98.96 for a unilateral exam. Average patient out-of-pocket (OOP) ranged from 5% to 54% of total. Average procedures per day ranged from 5 to 10 with a median of 6.995. This resulted in a breakeven on equipment cost within the first 12 months. Click here to download the full case study.

Make your mark with personalized screening using 3D ABUS
Operating four dedicated breast imaging centers at its hospital locations and several outpatient imaging centers in the Chicago area, NorthShore University HealthSystem performs more than 90,000 breast cancer screens annually.

NorthShore has embraced innovations in breast imaging to help improve evaluation of patients with high breast density, even though Illinois does not have a density inform law. One of the successful ways NorthShore has conducted personalized screening has been with the addition of Invenia ABUS. “With an abundance of available information on risk and breast density, and advances in breast imaging technology, every woman should be guided toward a clinical understanding of that risk by her breast health clinician and receive the screening that’s right for her,” said Dr. Georgia Giakoumis Spear, Section Chief and Clinical Assistant Professor of Radiology in the Department of Breast Imaging at NorthShore University HealthSystem.

“We’ve been able to overcome the limitations of the screening mammogram using 3D ABUS,” reported Dr. Spear. “The supplemental 3D ABUS screening tool has been invaluable on a personal level as a physician, enabling us to find a large amount of clinically significant, mammographically occult breast cancers, but we’re also hearing tremendous gratitude from our patients because we are finding these cancers at a time when they’re treatable and manageable.”

When Northshore adopted 3D ABUS, the first step was to inform and educate their immediate network. According to Dr. Spear, success lies in education and communication. “We have strong relationships with the breast surgeons and we work closely with the high-risk breast clinic. We expanded the education to include all of our referring physicians, including primary care physicians and OBGYN groups. Our intention was to make sure the larger clinical communities understood the impact of breast density and why we are performing these supplemental imaging studies in our practice,” said Dr. Spear.
Ramping up your 3D ABUS program
Incorporating 3D ABUS into practice involves initial adjustments to order, exam and reading workflows. Successful programs monitor progress, and adjust accordingly to achieve continuous improvements.

“With new technologies like 3D ABUS, radiologist training is very important to maintain good specificity. We have to expect some increase in callbacks when we add imaging tools to the screening process, but it is also reasonable to expect the increase to be proportional to the increase in cancer detection. Lastly, keep in mind that early in the adoption phase of 3D ABUS, we expect callback rates to be higher, as these are incident scans, as would also be expected to occur with screening mammography,” noted Dr. Marc Inciardi, Section Head, Breast Imaging, University of Kansas Medical Center – Kansas City, Missouri.

“Overcoming the learning curve and reducing the recall rate is more than simply getting used to the new format of 3D ABUS. It is about changing your mindset from diagnostics to screening – this is a huge paradigm shift as you have to learn that you’re not characterizing, you are determining whether the women can go until next year or if you need to recall her. This is a binary process – is the exam normal or abnormal? And, if it is abnormal, then we need to recall that woman for further evaluation,” said Dr. Susan Roux, Medical Director, Carol Hatton Breast Care Center-Monterey Peninsula (CHOMP), Monterey, California.

Beyond radiologist training, educating referring physicians and enabling easy order workflow are other keys to a successful implementation. “Education is crucial. Referring physicians need to understand the increased risk and have an easy way to order the exam. Ideally a conditional order process is set up to help the breast imaging center expedite the supplemental screening exam. Educating the imaging staff and registration staff is also critical so that they can communicate with patients and everyone is on the same page,” said Dr. Joseph Russo, St Luke’s University Health Network, Bethlehem, Pennsylvania.

Dr. Jason S. Davis, OSF Healthcare in Bloomington, Illinois, implemented ABUS and now it has become part of their routine day, “ABUS is breast ultrasound. It’s simply a new way of using a technology that has been around for a long time. ABUS provides a global view of the breasts, which helps give radiologists a better idea of “normal” for that patient. This has the opportunity to not only help reduce false positive but also reduce BI-RADS® 3, which is sometimes over-used on lesions that don’t look malignant but may not be benign either. 3D ABUS gives a global view and helps reduce operator dependence, which makes it easier to ignore false positives.”

As clinical evidence grows about increased cancer detection abilities of supplemental screening tools, density inform legislation expands, and patient demand increases, breast imaging centers will need to determine their own strategies for providing personalized imaging for dense breast patients. 3D ABUS is a tool designed for increased cancer detection, and offers additional benefits of efficiency, reproducibility and added revenue to healthcare providers.

Learn more about the benefits of Invenia ABUS



Developing a Personalized Screening Program
Dr. Joseph Russo, Section Chief of Women’s Imaging, St. Luke’s University Health Network, Bethlehem, PA

Dense Breast Tissue: Status of Ultrasound for Breast Cancer Screening
Dr. Marc F Inciardi, Assistant Professor of Radiology, Section Head, Breast Imaging, University of Kansas Medical Center, Kansas City, KS

Implementation of ABUS in the Community Setting
Dr. Monica H Saini, MS, Chief of Breast Imaging, Santa Fe Imaging/Christus Medical Center, Santa Fe, NM

Screening Ultrasound
Dr. Ian Grady, FACS, North Valley Breast Center, Redding, CA

Automated Breast Sonographic Coronal Imaging: Diagnostic and Screening Applications
Dr. Beverly E Hashimoto, FACR, Section Head, Ultrasound, Virginia Mason Medical Center, Seattle, WA

1. Boyd, et al: Mammographic density and the risk and detection of breast cancer, NEJM Jan 2007.

2. Boyd, et al: Mammographic density and the risk and detection of breast cancer, NEJM Jan 2007.

3. McCormack VA, dos Santos Silva I: Breast density and parenchymal patterns as markers of breast cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev 2006, 15:1159-1169.

4. Arora N, King TA, Jacks LM., Ann Surg Onc, 2010; 17:S211-18.

5. Boyd, et al: Mammographic density and the risk and detection of breast cancer, NEJM Jan 2007. 6. Berg WA. Screening Ultrasound. In: Berg WA, Yang WT, eds. Diagnostic Imaging: Breast, 2nd ed. Salt Lake City: Amirsys, 2014; p. 9:38-43.

7. Wilczek Brigitte, Wilczek Henryk E, Rasouliyan Lawrence, Lei?and Karin, Adding 3D Automated Breast Ultrasound to mammography screening in women with heterogeneously and extremely dense breasts. Report from a hospital based, high-volume, single-center breast cancer screening program., European Journal of Radiology http://dx.doi.org/10.1016/j.ejrad.2016.06.004.

8. Vourtsis A, Kachulis, A., The performance of 3D ABUS versus HHUS in the visualization and BI-RADS characterization of breast lesions in a large cohort of 1,886 women., European Radiology, 2017. ISSN 0938-7994 Eur Radiol DOI 10.1007/s00330-017-5011-9.

9. Wilczek Brigitte, Wilczek Henryk E, Rasouliyan Lawrence, Leifland Karin, Adding 3D Automated Breast Ultrasound to mammography screening in women with heterogeneously and extremely dense breasts. Report from a hospital based, high-volume, single-center breast cancer screening program., European Journal of Radiology http://dx.doi.org/10.1016/j.ejrad.2016.06.004.

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