Women’s Imaging: Local News — How Wireless Localization Technology Can Improve Patient Care
By Ananth Ravi, PhD, MCCPM
Radiology Today
Vol. 22 No. 1 P. 8

Just a few decades ago, breast lumpectomies were performed without localizing the tumor before surgery. It seems hard to imagine now, but a surgeon would make an informed decision about the tumor’s location and then remove a very wide margin of tissue around the mass. This led to the removal of healthy tissue and cosmetic outcomes that would not be acceptable today.

That’s why Howard Frank, MD’s, 1975 innovation—which used a guidewire to identify tumors—was such a groundbreaking development. Wire-guided localization (WGL) significantly reduced the amount of guesswork needed to identify and remove breast tumors. It allowed much less tissue to be removed from patients during lumpectomies, which also resulted in significantly smaller defects and substantially improved cosmetic outcomes for patients, for whom breast-tissue conservation is often an important consideration. That’s why, today, WGL is still the clinical presurgical standard and is used by radiologists to mark breast lesions in most hospitals around the world.

However, WGL isn’t perfect. It creates some logistical and scheduling complexity for radiologists and surgeons, it can cause a lot of discomfort for breast cancer patients, and wires can move or break. So, while WGL remains the procedure of choice today, clinicians and researchers are also continuing to develop new and better ways of localizing tumors.

There are several wire-free technologies that have been developed by various companies in the past few years. While the technologies vary, they share a common trait of using an implanted localization marker—such as a radioactive seed, a reflector, a radiofrequency tag, or a magnetic technology—that is inserted at the site of the lesion and located using a separate device.

These wire-free technologies offer a vastly improved patient experience. Implantable markers are far more comfortable and less painful than implanted guidewires. Unlike WGL, this new class of localization devices does not need to be implanted on the same day as the surgery—meaning the radiologist and surgeon do not have to be available at the same time, and the patient can go home after implantation. This makes the scheduling of radiology and lumpectomy appointments more convenient for both patients and health care professionals.

Conversely, WGL not only restricts the activities of patients on the day of surgery—preventing them from going home—but any delay in the implantation may also create challenges for the surgeons as well as scheduling challenges for the operating room. Also important is the patient experience. Some WGL patients faint in the hospital as they await surgery and—anecdotally, at least—many patients report the experience as highly uncomfortable.

Simply put, implantable markers allow a level of confidence and surgical planning that cannot be achieved with WGL. Implantable markers are more reliable because there is less risk of the marker being displaced from the target position, which in turn means that there will be fewer instances of adverse events or need for reimplantation. Location precision means the surgeon has a greater range of choices for where to make the incision, rather than only following the wire. This offers a greater range of options for the placement of the surgical scar—which is an important consideration cosmetically. In other words, these new techniques are the next step forward, in terms of patient-centered care.

Fundamental Questions
Unfortunately, that’s not where the story ends. Some vendors of these new implanted marker technologies are proposing they be used for purposes that they were never designed to support. For example, there is no evidence to suggest that implanted location markers can—or should—be used as biopsy markers. Nor is every lesion or patient a candidate for MR. Evidence-based guidance suggests that there are defined instances where MR is appropriate, such as for high-risk breast cancer patients where lesions are not visible on mammography or for patients undergoing neoadjuvant therapy but, frankly, any of the wire-free technologies could work in an MR-based workflow. 

This kind of “feature creep” may increase risk to patients because markers are not meant to be implanted for long durations. This kind of use may also drive up the cost of the product and make new localization techniques unaffordable for a vast majority of patients, which would be unfortunate because implanted markers, when used correctly, provide a much better patient experience and improve the flow of procedures as well. So, the selection of a replacement technology for WGL is far from straightforward. When selecting from available options, providers ought to focus on the fundamentals, not the frills.

To successfully choose and implement a new, wire-free technology, hospitals should consider using the following three-way test:

1. Does it improve the patient experience?
The question isn’t simply whether the patient will like the new technology better or if it is more comfortable. Rather, is the new technology a better experience from the point of implantation to the end of the surgery? Does it respect the patients’ time by helping them to be seen more easily? Is it accessible to all patients in all clinical settings, not just for patients who can afford care in large academic hospitals in big cities?

2. Will it make surgeons’ jobs easier?
Does the new technology address the limitations of existing workflows in both radiology and surgery? Does new technology need to be compatible with existing operating room equipment and tools? Will feature creep ultimately drive up costs of the new technology, or is a “right-sized” solution a better fit?

3. Is it safe and reliable?
What are the requirements for training and implementation? Are there known reliability issues with the technology? If you are implementing a radioactive seed localization program, is there ready access to a radiation safety program? After all, the technology being used needs to improve on a proven, existing technology. Has the product been sufficiently peer-reviewed and tested or proven clinically?

Overall, WGL is still an effective and accessible localization method for radiologists treating breast cancer patients. But this 50-year-old procedure has a lot of promising competition. New technologies can improve scheduling, provide a superior patient experience, and simplify the procedure for surgeons and the care team, leading to better access and improved health care. However, newer isn't automatically better, even if a procedure has been around since the 1970s. Decisions about which method to use must be based on what's best for the patient. That includes resisting the urge to give in to the feature creep of a new technology. 

Using implanted markers for other purposes may be technically possible, but it should not drive decision making. Any new method or technology must always be used to improve the patient experience, make it easier for surgeons to do their job, and provide solid, evidence-based results. Most importantly, though, it needs to be accessible and improve the quality of care for all patients. 

— Ananth Ravi, PhD, MCCPM, is the chief science and clinical officer and cofounder of MOLLI Surgical.