Women’s Imaging: A Look Ahead — Predictions for the Future of Tomosynthesis-Guided Breast Biopsy
By Susan C. Harvey, MD
Radiology Today
Vol. 21 No. 5 P. 28

There has been a dramatic evolution in breast biopsy technology over the years. Health care trends geared toward less invasive procedures have served as the driving force behind some of the most notable advancements within this space. The result is that a wide variety of evolving technologies are now available for radiologists and patients. As the health care industry continues to innovate at an unprecedented pace, it is valuable to consider what impact future developments will have on the breast biopsy space.

A Brief History
One of the earliest stereotactic breast biopsy devices was in the form of a spring-loaded needle. The primary target was calcifications, yet it was particularly challenging to obtain calcifications with this device. In addition, there were no available clip markers to locate the biopsy site, which was difficult in cases where the entire target was removed or no longer visible.

Spring-loaded devices gave way to new innovations and an early version of vacuum-assisted devices. Further iterations led the industry to more advanced vacuum devices, similar to those used today. Fortunately, over time, clip markers followed, better vacuum techniques were unveiled, and needle sizes were standardized.

One of the most influential changes to breast biopsy in recent history was tomosynthesis-guided biopsy, which was introduced in 2013. As digital breast tomosynthesis began to take hold, many radiologists were challenged to biopsy the subtle lesions and areas of concern that could only be viewed with the new technology. Tomosynthesis-guided breast biopsy overcame this gap.

The next big leap was the relatively recent introduction of technology with the real-time ability to verify whether a target lesion is contained within biopsy samples. Previously, separate steps and tools were required to accomplish tissue acquisition and imaging of samples to confirm that the target lesion had been sampled—all of which increased the time patients had to endure an already uncomfortable procedure. This new technology provides a way to image the specimen directly within the biopsy device at the time of sample acquisition, reducing the amount of time women spend under compression and improving workflow.

Where Technology Leads
Given these changes—from spring-loaded breast biopsy without markers to tomosynthesis-guided systems with real-time sample accuracy verification—the future of breast biopsy may look dramatically different. By considering the residual inefficiencies of today’s procedures and layering on the trends currently driving health care innovation, we can deduce where the future of breast biopsy may take us. The central goals will be to improve patient outcomes and experience as well as address workflow and the cost of care.

A Significant Role for AI
AI is permeating nearly every facet of health care. There have been exceptional advances made with AI-guided technologies that assist physicians in providing better patient outcomes as well as more accurate and efficient care. The trend is predicted to continue as we move forward, and interventions in breast imaging are no exception.

An AI-driven targeting tool could potentially improve the accuracy of breast biopsy procedures. Although not a large problem, there is always room for improvement. An AI algorithm or reconstruction could help clinicians visualize the full target lesion and improve the accuracy of biopsies. For example, AI may one day help prevent scenarios in which radiologists place a needle and push the target out of the way, as opposed to piercing it.

An AI-generated 3D view of the lesion would allow for more precise core biopsy sampling to be obtained, which could potentially decrease the number of upgrades from atypia to ductal carcinoma in situ (DCIS) and from DCIS to invasive cancer. This kind of tool could also assist with specimen assessment to ensure that a radiologist has removed the entire target lesion from the breast.

Fewer Specimens Needed
Trending across the breast health care continuum are efforts to prioritize patient outcomes and experience, improve workflow, and reduce procedure time, all while retaining the highest quality of care. In the future, these priorities could intersect with new technological improvements to reduce the number of specimens that radiologists need to take, while ensuring appropriate and accurate diagnoses.

Recently introduced biopsy technologies allow for real-time verification that a target is within a sample during a biopsy procedure. Further research may eventually show that radiologists can confidently take fewer samples with the support of these technologies without negatively impacting patient outcomes. Fewer samples generally means fewer hematomas and a less invasive procedure for patients, which can ultimately lead to an increase in patient satisfaction.

Benign Biopsy Rates Will Drop Dramatically
In the United States, approximately 80% of breast biopsies are benign.1 Not only are women undergoing procedures that ultimately do not result in cancer detection, but these benign biopsies also lead to time and resource use with no improvement in patient outcomes. The challenge is that, with current anatomically based imaging tools, there is no way to accurately determine whether a lesion is benign or malignant before recommending a breast biopsy.

As the health care industry transitions from fee-for-service to value-based care, facilities are striving to provide better outcomes while simultaneously cutting waste. This transition will likely lead to the increased use of existing and emerging technologies to help physicians more accurately assess whether a lesion is benign or malignant prior to biopsy, ultimately reducing the total volume of breast biopsies and deflating the benign breast biopsy rate in the United States.

Faster Diagnosis Confirmation
Consider the possibility of making a diagnosis almost instantly, right from the biopsy procedure room. It is a tantalizing goal: transforming the patient pathway while maintaining accuracy. Emerging technologies hint that a future exists where histopathologic slides will not require processing and staining or rapid point-of-care diagnostics will achieve this. So, potentially, tomorrow’s radiologists will make a diagnosis much more rapidly, right at the time a specimen is taken.

More Sustainable Procedures
Global conversations surrounding sustainable solutions have been amplified in recent years. As this issue takes center stage, the health care industry will be challenged to consider where and how its environmental impact can be minimized, particularly with regard to disposables. To that end, it is likely that medical device manufacturers will begin to introduce new and more sustainable ways to perform breast biopsy procedures that minimize waste overall.

While it is certainly not possible to know exactly what the future of breast biopsy will look like, we can trust that the trends driving health care today will influence tomorrow’s innovations. The industry has certainly advanced in extraordinary ways from the first iterations of breast biopsy technology. And with more than 1 million women undergoing breast biopsy procedures in the United States annually, there is ample room to deliver innovative solutions to ensure women enjoy the best possible health care.

— Susan C. Harvey, MD, is the vice president of global medical affairs in the breast and skeletal health division at Hologic, Inc.

Reference
1. Biopsy. BreastCancer.org website. https://www.breastcancer.org/symptoms/testing/types/biopsy. Updated October 7, 2015.