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A better breast biopsy.
2D-generated versus FFDM 2D images in breast tomosynthesis screening programs.
picture Researchers at Christiana Care Health System's Helen F. Graham Cancer Center & Research Institute in Newark, Delaware, compared the clinical performance of the Hologic 3D MAMMOGRAPHY™ system with generated 2D images using Hologic C-View™ software with that of the Hologic 3D MAMMOGRAPHY™ system plus conventional FFDM 2D digital mammograms and Hologic digital mammography alone.1

The researchers studied 78,810 screening mammograms performed from 2011 to 2016. In the study group, 32,076 women were screened with conventional digital mammography, 30,561 women were screened using breast tomosynthesis plus digital mammography and 16,173 women were screened using breast tomosynthesis with 2D images generated from the tomosynthesis data set in place of the conventional 2D images. Performance was assessed by looking at recall rate, cancer detection rate and positive predictive value (PPV), or the ability to predict if an image-detected abnormality is cancer.

The percentage of invasive cancers detected was significantly higher with tomosynthesis and 2D-generated images than with tomosynthesis plus digital mammography, and the positive predictive value of biopsies performed in women following tomosynthesis plus 2D-generated images was significantly higher than in those screened with tomosynthesis plus digital mammography.

Key study results are shown in the table below.

Graph 2

The researchers found that recalls were significantly lower when women were screened with 3D MAMMOGRAPHY™ and 2D images generated from the tomosynthesis data set as compared with women screened with 3D MAMMOGRAPHY™ plus digital mammography and compared with digital mammography alone. The results of the study also suggest that adoption of 2D-generated images in combination with 3D MAMMOGRAPHY™ into screening programs would reduce the number of false-positive findings – an important consideration in the age of value-based medicine.

In a press release issued by the Radiological Society of North America (RSNA), Dr. Jacqueline Holt described the findings as both encouraging and surprising, especially given the fact that with breast tomosynthesis plus 2D-generated images, the positive predictive value went up. "If synthesized 2D imaging is performed, you'll get equal or better patient outcomes and go to a lower radiation dose," she says. "These findings could be a practice-changer globally."

It’s important to note that just as all tomosynthesis systems are not approved for or clinically proven to offer superior performance, the same applies to synthesized 2D images.

>>Read study abstract

Researchers at the Hospital of the University of Pennsylvania evaluated the early implementation of using 2D mammography images generated from a Hologic tomosynthesis data set in a large urban practice.2 The retrospective study compared recall rates and cancer detection rates to historic outcomes of FFDM digital mammograms combined with Hologic 3D MAMMOGRAPHY™.

Cancer detection and invasive cancer detection rates were comparable between generated 2D/tomo and 2D/tomo. Cancers per biopsy performed increased with generated 2D/tomo versus 2D/tomo. The recall rate for generated 2D/tomo versus FFDM 2D/tomo was 7.1% versus 8.8%, respectively (p<.001). The average glandular dose was 39% lower when generated 2D/tomo was used versus FFDM 2D/tomo (p<.001).

The data suggests that replacing FFDM 2D images with 2D-generated images in tomosynthesis breast screening yields screening outcomes similar to FFDM 2D/tomo with a significantly lower radiation dose.

Key study results are shown in the table below.

Graph 3
Click on the Hologic website, LowDose3D.com, for more information on this new technology.
More Research on Breast Tomosynthesis
An analysis comparing the cancer detection rate for single reading of integrated 2D/3D MAMMOGRAPHY™ (8.2 per 1,000 screens) was statistically significantly higher than for double reading of 2D mammography (6.3 per 1,000 screens), and the same findings were shown for single reading of 2D-generated/3D MAMMOGRAPHY™ (8.4 per 1,000 screens).3

The researchers also reported another advantage of exploring a screening model based on single reading of 3D MAMMOGRAPHY™ (either 2D/3D™ or 2D-generated images/3D™) is that it also reduces false-positive recalls by a small, but statistically and clinically significant proportion.

Breast cancer detection rates for single reading versus double reading in the STORM-2 trial
Graph 4

The authors conclude that it may be time to rethink the breast cancer screening model used in many population-based screening programs by highlighting the potential for 3D MAMMOGRAPHY™ technology to support less resource-intensive screen-reading practices.

This study is a secondary analysis based on the results from STORM-2 (Screening Tomosynthesis OR Mammography), which found that double-read tomosynthesis screening cases (tomosynthesis with FFDM or 2D-generated mammography images) detected more breast cancers than double-read 2D mammography cases. (Lancet Oncology. 2016 Aug;17(8):1105-13. doi: 10.1016/S1470-2045(16)30101-2. Epub 2016 Jun 23.)

>>Read more

In a study funded by Hologic published online January 27 in the Journal of the American College of Radiology, researchers reported that using breast tomosynthesis in combination with digital mammography among Medicaid enrollees potentially translates into more than $12,000 savings per year for an average-sized Medicaid plan and as much as $207,000 savings per year for a typical state Medicaid plan. Even better, these cost savings would come from fewer recalls and earlier cancer detection, which benefit the women themselves, the authors wrote.

The primary driver of breast tomosynthesis economic value comes from the capacity of tomosynthesis to reduce the number of women recalled for additional follow-up imaging and diagnostic testing services and the corresponding reduction in the costs of healthcare resource utilization. A secondary driver of the economic value of breast tomosynthesis is the technology’s capacity to facilitate earlier diagnosis of cancer, particularly the diagnosis of cancers at earlier stages, when treatment costs are less. Together, these value drivers offset additional reimbursement costs for breast tomosynthesis and produce a potential net cost savings for Medicaid plans.

For the study, researchers used an economic model developed to estimate the financial impact of breast tomosynthesis combined with conventional digital mammography for breast cancer screening. Data for the model came from the Truven Health Analytics Medicaid Multi-State Database, which includes information from more than 31 million Medicaid enrollees from 12 states.

The group evaluated two annual screening scenarios – digital mammography alone and digital mammography plus breast tomosynthesis – in the context of a hypothetical, average-sized state Medicaid program of 1.4 million enrollees. For the model, the group assumed a digital mammography follow-up rate of 14.4% and that adding breast tomosynthesis would reduce that rate to the American College of Radiology benchmark of 10%. It also assumed a reimbursement rate for breast tomosynthesis of $37.

>> Download PDF of open access study
The recently released IMV ServiceTrak™ Report for X-Ray Mammography Systems ranked Hologic #1 in almost all of the significant areas covered in the report. Ratings are based on the opinions of users representing systems currently in operation in U.S. hospitals and independent radiology centers.
Hologic rankings for the last 4 measurement periods
Graph 1

IMV Limited, is an independent healthcare research company. This is the 18th time that IMV has published an X-Ray Mammography ServiceTrak report.

>>Read more
More News of Note

At least five more states, identified by the American College of Radiology (ACR) Statescape State Legislative Roundup, are considering legislation that would require healthcare insurers to cover breast tomosynthesis.

Maryland SB 61
Establishes that a specified coverage requirement that applies to specified insurers, nonprofit health service plans and health maintenance organizations includes coverage for digital tomosynthesis under specified circumstances; prohibits a copayment or coinsurance requirement that is higher than other breast cancer screenings; applies the act to all policies, contracts and health benefit plans issued, delivered or renewed in Maryland on or after Jan. 1, 2018.

New Hampshire SB 189
Requires insurance policies to cover 3D mammography. Expands the definition of "low-dose mammography" to also include 3D tomosynthesis mammography.

New Jersey AB 4320
Mandates that health insurers provide coverage for digital tomosynthesis for screening and diagnostic purposes related to breast cancer. Requires health insurers and health maintenance organizations, as well as health benefit plans or contracts, to provide coverage for expenses incurred while conducting digital tomosynthesis to detect or screen for breast cancer in women 40 years of age and over and for diagnostic purposes in women of any age.

New York SB 1709
Requires insurers to cover three-dimensional mammograms under mammography services and extends exclusion from annual deductibles and coinsurance to such services.

Texas HB 1036
Adds a definition of "breast tomosynthesis" and relates it to coverage for certain breast cancer screening procedures under certain health benefit plans.

In addition to Statescape, the ACR has created a Breast Tomosynthesis Resources Page to help its members work with private payers to secure coverage of this important technology.

Updated FDA MQSA guidance for breast tomosynthesis

The U.S. Food and Drug Administration (FDA) has updated its guidance on Mammography Quality Standards Act (MQSA) training requirements for breast tomosynthesis. Manufacturer-specific training is no longer required; personnel need only obtain training on one breast tomosynthesis system or obtain general breast tomosynthesis training to meet the modality training requirement, the FDA said. However, because some systems have unique features, users are encouraged to receive additional training as needed.

>> Download PDF of new guidelines

Use of breast tomosynthesis in the U.S.

Despite the demonstrated clinical benefits of breast tomosynthesis, and increasing use of the technology, adoption is inconsistent across the U.S., according to a study published online February 7 in Academic Radiology.5

picture Why? Most likely due to variations in reimbursement and a lack of standardized guidelines, researchers from New York University School of Medicine wrote. And these factors could be preventing women from taking advantage of tomosynthesis technology benefits.

The researchers sent surveys to 7,023 breast radiologists whom they identified using an RSNA database. The survey solicited information such as respondents' geographic location and practice type, length of breast tomosynthesis use, patient selection criteria, and recall rate.

Of the 1,156 radiologists that responded: 65.8% were from the U.S. and 34.2% were international. The majority (68.6%) of survey participants use breast tomosynthesis. Of those who reported they were not using breast tomosynthesis, 43% stated they planned to adopt the technology.

The majority of radiologists had been using breast tomosynthesis between one and three years (60.2%), and most were using the technology for screening (89%) and diagnostic evaluation (92.7%). Only about 30% of survey respondents stated that they used breast tomosynthesis for all screening patients; those who specified particular screening criteria listed dense breast tissue, high risk status, prior imaging with tomosynthesis and patient request for the technology.

Eighty-four percent of the survey participants who were using breast tomosynthesis said they used the Hologic 3D MAMMOGRAPHY™ system.

>>Read more

Mammography: an update of the EUSOBI recommendations on information for women

The European Society of Breast Imaging (EUSOBI) and 30 national breast radiology groups strongly support mammography as a population-based screening tool in a position paper published online in advance of print in European Radiology and a follow-up article in Insights into Imaging. The societies reviewed the increasing evidence in favor of breast tomosynthesis as a screening tool and noted that breast tomosynthesis is now proposed along with synthetic 2D views, practically solving the problem of increased radiation exposure when breast tomosynthesis is performed with 2D digital mammography. The position paper concludes that “People and institutions questioning its validity despite a large body of evidence accumulated in over more than three decades, put women’s lives at risk."

>>Read more

Upcoming Hologic Educational Programs & Events
The Hologic-supported CME-accredited seminars listed here are conducted by leading experts using the specific technology as noted in a screening and diagnostic practice. Locations/dates are subject to change. The seminars range from workshops to full eight-hour training sessions. For more information and to register, please access the links below.

Hands-on Seminars
for Physicians & Technologists
These programs are supported by Hologic with an unrestricted educational grant.
Master Technologist
NCoBC, Las Vegas, NV
March 13-14, 2017
Fundamentals of Tomosynthesis Workshop
WCCME, New York, NY
April 1, 2017
Advanced Tomosynthesis Workshop
WCCME, New York, NY
April 2, 2017
Breast Imaging Symposium
SBI/ACR, Los Angeles, CA
April 5-9, 2017
Breast Imaging Boot Camp with Tomosynthesis
ACR, Reston, VA
April 20-22, 2017
June 15-17, 2017

Breast MR with Guided Biopsy
ACR, Reston, VA
April 24-25, 2017

Live & Archived, Accredited On-demand Webinars
These complimentary programs are supported by Hologic with an unrestricted educational grant.
ICPME: International Center for Postgraduate Medical Education
3D Imaging-guided Prone Breast Biopsy: Initial Clinical Experience
1.0 AMA PRA Category 1 Credit / 1.0 ARRT Category A Credit
Presenter: Dr. Debbie Lee Bennett, Director, Breast Imaging, St. Louis University Hospital
Breast Ultrasound Imaging with Multimodality Correlation
1.0 AMA PRA Category 1 Credit
Presenter: Dr. Catherine Appleton, Washington University School of Medicine, St. Louis, Missouri
Breast Biopsy with Tomosynthesis: How? When? Why?
1.0 AMA PRA Category 1 Credit / 1.0 ARRT Category A Credit
Presenters: Dr. Jules H. Sumkin, Professor and Chair, Dept. of Radiology, University of Pittsburgh Medical Center, and Dr. Margarita L. Zuley, Professor and Medical Director, Breast Imaging, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Clinical Use of 3D Image-guided Prone & Upright Breast Biopsy
Live: April 19, 2017 (English)
or April 20, 2017 (Spanish) 1.0 AMA PRA Category 1 Credit / 1.0 ARRT Category A Credit

Presenter: Dr. Alejandro Tejerina, Director of Breast Imaging, Breast Pathology Center of Madrid
Contrast Enhanced Digital Mammography
1.0 AMA PRA Category 1 Credit / 1.0 ARRT Category A Credit
Presenter: Dr. John M. Lewin, Breast Imaging Specialist, Diversified Radiology of Colorado, PC and Medical Director, Rose Breast Center, Denver, Colorado
Osteoporosis Update 2015: It's All About the Fractures
1.0 AMA PRA Category 1 Credit / 1.0 ARRT Category A Credit
Presenter: Dr. Ethel S. Siris, Madeline C. Stabile Professor of Medicine, Columbia University Medical Center, New York City, New York
State of the Art Mammography: The Role of Full Field Digital Imaging, Generated 2D Images and Breast Tomosynthesis
1.0 AMA PRA Category 1 Credit
Presenter: Dr. Linda R.N. Greer, Medical Director, HonorHealth Breast Research Center, Phoenix, Arizona
Synthesized 2D Mammography + Breast Tomosynthesis
1.0 AMA PRA Category 1 Credit / 1.0 ARRT Category A Credit
Dr. Emily F. Conant, Division Chief, Breast Imaging at the Hospital of the University of Pennsylvania
Visceral Fat: The Invisible Health Risk
1.0 AMA PRA Category 1 Credit / 1.0 ARRT Category A Credit
Dr. Vyvyane Loh, Transform Institute for Metabolic & Lifestyle Medicine, Newton, Massachusetts

Optimizing the Well Woman Visit: Improving Patient Conversations, Improving Women's Health
1.5 contact hours of CE credit and .5 contact hours of pharmacology content
Presenters: Dr. Sharon Mass; Nancy Berman, ANP-BC; and Suzanne Reiter, NWNP-BC
Applied Radiology
Breast Tomosynthesis and Synthesized 2D Imaging Part I and II
1.0 AMA PRA Category 1 Credit & 1.0 ARRT Category A Credit
Presenters: Dr. Elizabeth A. Rafferty, Director of Breast Imaging Programs, L&M Radiology, Lawrence, Massachusetts, and Dr. Aron J. Belfer, CDB-Premium, one of Brazil's largest private imaging centers
For information and to register, visit www.hologic.com/training
Low Dose 3D MAMMOGRAPHY™ Imaging with C-View™ Software Training
Non-CME hands-on case-based training for radiologists
Presenters: Dr. Linda R.N. Greer and Andrew Smith, PhD
Advancements in 3D MAMMOGRAPHY™ Technology for Technologists
1.0 ARRT Category A Credit
Presenter: Marcy Adcox, RT R M, San Diego, California
Introduction to Breast Tomosynthesis for Technologists
1.0 ARRT Category A Credit
Presenter: Marcy Adcox, RT R M, San Diego, California
I-View™ Software for Contrast Enhanced 2D Imaging
1.0 ARRT Category A Credit
Presenter: Marcy Adcox, RT R M, San Diego, California
Technologist's DXA 101 - The Basics of Bone Densitometry
1.0 ARRT Category A Credit
Presenter: Debra Burnham, BS, RT R M BD, Bedford, Massachusetts
Understanding Body Composition Assessment with Visceral Fat
.5 ARRT Category A Credit
Presenter: Nancy Fagan, RT R M BD CBDT, Bedford, Massachusetts

1M Aujero, S Gavenonis, R Benjamin, Z. Zhang, and J. Holt. “Clinical performance of synthesized two-dimensional mammography combined with tomosynthesis in a large screening population.” Radiology online in advance of print. February 21, 2017.

2S Zuckerman, E Conant, B. Keller, A. Maidment, B. Barufaldi, M. Weinstein, M. Synnestvedt, and E. McDonald. “Implementation of synthesized two-dimensional mammography in a population-based digital breast tomosynthesis screening program.” Radiology 2016 Dec;281(3):730-736. Epub 2016 Jul 28.

3N Houssami, D Bernardi, M Pellegrini, M Valentini, C Fanto, L Ostillo, P Tuttobene, A Luparia, and P Macaskill. “Breast cancer detection using single reading of breast tomosynthesis (3D-mammography) compared to double reading of 2D-mammography: Evidence from a population-based screening trial.” Cancer Epidemiology. April 2017, Vol. 47, pp 94-99. (published on line in advance of print).

4J Miller, M Bonafede, S Herschorn, S Pohlman, K Troeger, and L Fajardo. “Value analysis of digital breast tomosynthesis for breast cancer screening in a U.S. Medicaid population.” Journal of the America College of Radiology. 2017 Jan 26. pii: S1546-1440(16)31328-X. doi: 10.1016/j.jacr.2016.11.019. [Epub ahead of print]

5Y. Gao, J Babb, H Toth, L Moy, and S Heller. “Digital breast tomosynthesis practice patterns following 2011 FDA approval: a survey of breast imaging radiologists.” Academic Radiology. 2017 Feb 7. pii: S1076-6332(17)30013-2. doi: 10.1016/j.acra.2016.12.011. [Epub ahead of print]

6F. Sardanelli, HS Aaase, M Alvarez, et al. Position paper on screening for breast cancer by the European Society of Breast Imaging (EUSOBI) and 30 national breast radiology bodies from Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Israel, Lithuania, Moldova, The Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Switzerland and Turkey. Eur Radiol. 2016 Nov 2. [Epub ahead of print]

7F Sardanelli, EM Fallenberg, P Clauser, RM Trimboli, J Camps-Herrero, TH Helbich, G Forrai; European Society of Breast Imaging (EUSOBI), with language review by Europa Donna–The European Breast Cancer Coalition. Mammography: an update of the EUSOBI recommendations on information for women. Insights into Imaging. 2017 Feb;8(1):11-18. doi: 10.1007/s13244-016-0531-4. Epub 2016 Nov 16.

Hologic, 3D, 3D Mammography, C-View, I-View, The Science of Sure and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the U.S. and/or other countries. All other trademarks, registered trademarks and product names are the property of their respective owners. This information is intended for medical professionals in the U.S. and other markets, and is not intended as a product solicitation or promotion where such activities are prohibited. Because Hologic materials are distributed through websites, eBroadcasts and tradeshows, it is not always possible to control where such materials appear. For specific information on what products are available for sale in a particular country, visit Hologic.com.

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