Jul 19, 2017
Q&A with Dr. Christine Dauphine on LOCalizer
Q: What has been your personal experience with LOCalizer? What were some of its advantages compared to some of the other methods?
A: What LOCalizer does, that [other methods] specifically don’t do, is tell you the distance to [the RFID tag]. That sets it apart and is the most exciting feature about it. When you have a standard [wire localization] device, the wires are rather flexible and predicting exactly where you are going can be difficult, especially in larger breasted women and with deeper lesions, where the wire can take a torturous route toward the lesion. Having an audible noise that gives some indication of location and how far you are from the target, allows you to better find the lesion compared to the standard wire method. This also allows you to put an incision potentially more remotely, because then you can see how far you are from the lesion when you are approaching.
Q: This sounds like a new technique you haven’t been able to do in your career up until now.
A: Yes. The majority of surgeons out there doing breast surgery are going to have some experience with wires. That’s been the standard for a long time. The next devices that tried to solve the problem of having something hanging externally outside of the breast were radioactive seeds and hydrogel markers, which are both completely implantable, so you don’t have the problem of needing to take the patient to OR on the same day as placement of the localization device.
With radioactive seeds, there are a number of medical regulations and a complex application process prior to initiating a seed program. There is also a great deal of hesitance on the part of the many people involved in handling the radioactive materials during placement and processing the specimen. A radiologist would have to place the seed, a surgeon would have to remove it with the specimen, then it would go to a pathologist.
Hydrogel markers can be placed at the time of the biopsy and identified intraoperatively with ultrasound. However, migrations away from the target have been noted, and utilizing this as the sole localization method requires the surgeon to have access to an ultrasound and be adept at using it to guide the excision. Very often the hydrogel marker serves as a target for the radiologist to more easily place a wire, rather than guide the surgeon directly.
More recently, you are seeing devices that are implantable, but not radioactive, and that produce a sound to direct the excision. The issue with these devices, though, is that you know the direction you need to operate, but it is still difficult to make a remote incision when you don’t know how far you are from that little tag. That’s where LOCalizer benefits - it is completely implantable, non-radioactive, doesn’t require special skills with ultrasound, and allows you to determine the distance from the end of the hand-held probe to the tag.
Q: What are some of the patient benefits that you see for LOCalizer?
A: The real benefit for the patient is that they don’t have to come in on the day of surgery to have an additional painful procedure done. It’s already an anxiety-ridden process—they have to come in the morning, be stuck with a needle to give local anesthesia and have the wires put in. Even if it’s quick, having to do that on the day-of adds to the anxiety around everything. So, if you can avoid that—great! With the LOCalizer, patients can come in a week or two before surgery to have the tag implanted. If you can get to the point where we can place this tag permanently at the very beginning when the biopsy is done, that would be even more of an extraordinary benefit to the patient.
Also, being able to determine the distance to the tag allows the surgeon to locate the incision in a more hidden location, so the patient isn’t stuck with an ugly scar in an undesirable location.
Q: Do you think localization techniques need to evolve, and if so, why is that?
A: Most people are still placing wires—and I think any surgeon will tell you that complicates their OR schedule. Usually these procedures can’t be your first case of the day, so the vast majority of people schedule these as their second or third patient of the day. But if you have cancelations, you can’t always plan it that well. I’ve heard of people trying to place wires the day before, just to try to fix this problem.
The excitement for LOCalizer is the efficiency of coordination between surgeons and radiologists. For example, if wire placement takes longer than expected, then your OR is down for a period of time, or the OR won’t wait for you and then they will put someone else’s case in there and you are stuck waiting. Surgeons will tell you over and over that coordination between everything can be complicated, so if we can avoid that, then that is the biggest draw. It streamlines the whole experience; you don’t have to wait for a radiologist to place the wire that morning, and the patient can come in just for the procedure. A better experience for the patient is definitely a plus, but the biggest operational benefit is scheduling.
And then there is the smaller subset of things that happen—the OR becomes unavailable, a prior case takes longer than expected, or the patient may be unfit to undergo anesthesia that day, and now you’re left with a patient with a wire in their breast. It’s not common, but it does happen. It’s so great to have something completely implantable, so if there is a reason that you can’t operate on that patient that day, you can very easily reschedule to a convenient time without risk to the patient.
If you have done wire-localized excisions, then you certainly have had frustrating cases where the end of the wire was not where it seemed to be. Maybe the patient had a bigger breast, the wire was placed really deep into the breast, or you don’t do very many of these procedures. The signal from the LOCalizer helps avoid these issues. You’re making the procedure itself much easier than it is with a wire. You’ll be able to say that the tag is right here, it’s 3 centimeters down and I’m going to make my cut here. Once the lesion comes out, you can then use the probe to ensure that tag is completely within that specimen before you take the specimen to pathology.
Jan 26, 2017
Awarded worldwide distribution rights for LOCalizer™.