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Affirm: New Tool for Breast Cancer Diagnosis – In-Depth Doctor Interview

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Debbie Bennett, M.D., Director of Breast Imaging at SSM Health Saint Louis University Hospital in St. Louis, Missouri, talks about a new 3D biopsy system that helps doctors better diagnose breast cancer.

Interview conducted by Ivanhoe Broadcast News in January 2017.

 

Let’s ask you a little bit first of all about the Affirm system?

Dr. Bennett: Sure, the Affirm biopsy system is a breast biopsy system and it relies on mammographic imaging. A lot of times, when we look at somebody’s mammogram, we see an abnormality that we can only see on the mammogram. Sometimes, the only way to check it and make sure that it’s okay is to do a biopsy. But there has to be a way to see what it is that you’re seeing on the mammogram on the biopsy table. So this is the system that allows us to do that safely for patients.

What is new about this particular system that makes it a little more focused or a little bit better?

Dr. Bennett: The main thing that’s new about this system is that it uses 3D imaging guidance. A lot of people probably have now gotten the 3D mammogram or have heard about 3D mammograms, very exciting for breast imaging because it allows us to find more cancers. But at the same time it allows us to have fewer false positive tests. We’re basically better at reading mammograms with 3D imaging. Before the Affirm system came along there wasn’t a great way to biopsy abnormalities that we could only see on the 3D mammogram and so this really fills the needs that the technology had created.

You had mentioned the fact that this probably doesn’t eliminate false positive, but it cuts down on the number of false positives. Could you speak to that a little bit? What happens when there’s a false positive for a woman? Why is it important that we cut down on this?

Dr. Bennett: False positives are really a big problem in mammography. When we look through screening mammograms our job is to say, do we think that there’s possibly something abnormal here on this image. We purposely set our bar really low because you don’t want to miss cancers. The problem with setting your bar low is that if you cast a wide net you’re going to catch a lot of fish. You’re going to catch a lot of things that aren’t cancer, and that causes a lot of anxiety for our patients. They get a phone call from us saying, you know, we would like you to come back and take a look at something. Of course everybody’s mind goes down this garden path and they think “Oh my gosh, I have cancer.” It takes time out of their day to come back in to get more imaging and tests done. So the fewer women that we can cause that unnecessary worry and anxiety for, the better.

In what ways does this help eliminate that fear and that problem?

Dr. Bennett: The biopsy system itself doesn’t really help us that much with the general problem of false positives. But what it allows us to do is have a much easier way to get a definitive diagnosis when we’re on the fence about what something is, whether it’s a cancer or not. Previously, for findings on a mammogram where we could only see it on the 3D part, we used to have to have patients do a surgical biopsy. Meaning they would see our breast surgeon, they’d have to fast the night before, come in to the operating room, get an IV, and anesthesia. Now, we’re able to do the biopsy and get a definitive answer for them in about a twenty minute office procedure.

When you cut down on that time, can you talk to me a little bit about that, how much of relief that could be for patients?

Dr. Bennett: It saves time for patients in a lot of ways. It reduces the amount of time between being told that you need a biopsy and when you get an answer back. In the majority of cases, the answer is that it’s not cancer. You get a lot reassurance and peace of mind instead of having to go through all of the steps of seeing a surgeon, getting preoperative clearance, booking a date in the operating room, many times we are even able to do a procedure on the same day.

Then right there, you have the answer and you’re not waiting.

Dr. Bennett: Absolutely.

If you could walk me through the steps and how this works?

Dr. Bennett: Sure. This is very similar to old mammographic guided biopsy tables. Some of your viewers may have heard the word stereotactic. It’s the same kind of biopsy system in that the patient is asked to lie on the table on her stomach. It sounds crazy and we always tell patients there’s no graceful way to get up there on your stomach, but we have them lie on their stomach where there’s a hole in the middle of the table and their breast goes through the hole. We’re actually working underneath the patient. For a lot of people it’s not even the breast that bothers them, it’s just something about being on the table for a few minutes that’s uncomfortable. Underneath the table there’s a mammogram unit that’s been turned on its side. In this case, it’s now a 3D mammogram unit that we have. We take pictures of the breast, just like we would for a normal mammogram. We identify the area that we’re targeting for the biopsy. We numb up the patient with just some local numbing medicine. It’s essentially like having a cavity filled now, except we’re working in your breast. We place a small biopsy device in the breast, we take a few samples and check that we like the area that we’ve taken samples from. Then, when we’re done, we leave a little marking clip behind so that everybody who comes after us knows that that area has already been biopsied.

What is the benefit of lying prone? Is there a benefit of having a woman in that position?

Dr. Bennett: The benefit is that it gives us a lot more access to the breast. If you think about it, most breasts are very mobile, they change in shape depending on how you’re sitting, you’re standing, and you’re lying. If the patient is lying on their back, their breast is actually going to be very flat. What we need is to be able to spread the tissues apart so that we can precisely pinpoint one area of the breast. That’s accomplished the best by having somebody lie on their stomach.

Without this system, how would a biopsy be done just in comparison?

Dr. Bennett: There are a couple different ways of doing biopsies in general. Image guided biopsy can be done with any imaging technology. We can do biopsies of ultrasound guidance, we can do biopsies with MRI guidance or we can do biopsies with traditional stereotactic or mammographic guidance which is only 2D mammography. The whole other kind of biopsy bucket is a surgical biopsy which is also known as an excisional biopsy. That’s the kind of biopsy that we were talking about before that actually requires a surgeon to do. Many times we will localize the area for our surgeon by placing a wire in the breast before the surgery. But it’s a much bigger deal to have a surgical biopsy than a needle biopsy with imaging guidance.

In terms of recovery time, is it easier with what you’re doing now?

Dr. Bennett: Absolutely. The recovery time is really minimal. The only thing that the patient sees is a very tiny nick in the skin from where the needle was placed in the skin. It’s very similar to having had an IV placed. More than saying “take it easy, pamper yourself through the next day,” there really aren’t any activity restrictions or any recovery to speak of.

How much more accurate is this in your opinion than the traditional biopsy or a 2D biopsy?

Dr. Bennett: It is much more accurate in that we didn’t have a way at all to biopsy 3D-only findings before. A lot of times we will try and see if we can find the area that we see on a 3D mammogram with the ultrasound machine, but in many cases, if you do that it’s kind of a guess because you’re hoping that you’re seeing the same area using one technology: the ultrasound technology that you’ve identified compared with the original 3D mammogram technology. Having a way to really compare apples to apples, to see something on the 3D mammogram and biopsy using 3D mammogram technology really allows us to be much more confident about the areas that were biopsy.

We like to ask you one question if you don’t mind, because we do get these questions from our viewers a lot. For which women or for whom is the 3D mammography really a better way to go then the 2D? I know it’s one of those controversial things. But that’s when we do these stories we actually get the call from the office. So I wanted to have maybe something I could send them. What do you recommend?

Dr. Bennett: The data actually shows that 3D mammography is better for all groups of women than 2D mammography. The downside of 3D mammography used to be the radiation dose associated with it. When 3D mammography started, almost all facilities were actually doing a combination mammography picture. They were taking the standard 2D pictures and then adding the new 3D pictures. We have really moved away from that and reduced the radiation doses because we’re now able to construct a synthetic 2D mammogram from the 3D image sets which means that were no longer doing both pictures. The radiation dose has come down by half essentially. When you take that out of the picture, the only other factor that really comes in to play for women is cost. Here we don’t charge extra for 3D, but I think a lot of places around the country still do because the insurance coverage is not consistent. If cost is a factor for your viewers then I would say the women who benefit the most from having 3D mammography are women who are younger and who have dense breasts. And increasingly having dense breasts is something that people would know from a letter from their mammogram facility.

If you have dense breasts what would you recommend?

Dr. Bennett: If you have dense breasts I would say a 3D mammogram is absolutely the way to go. The reason is because breast density is normal; half of our population has dense breasts. But the problem is that it’s much more difficult for us to read a traditional mammogram because we’re looking for cancer, which is white, in the background of more white tissue. Instead looking for a small white dot in a background of black we’re looking for it in a sea of white. When you take one picture and the whole image stack is compressed it can be very difficult, but the 3D mammogram allows us to tease apart the different layers of the breast so the cancer detection is much better.

Any downside beside the cost of 3D again, I mean a different way?

Dr. Bennett: No, essentially not. It’s very fast. A lot of our women will call back and even ask if they had a 3D mammogram because they don’t realize that’s the test that they had.

Is there anything I didn’t ask you about Affirm that you want to make sure people know?

Dr. Bennett: I don’t think so. I think that’s basically it.

How long have you guys had this procedure, just a few months?

Dr. Bennett: We got it installed in June. We started using it I think in early July and I believe we were the first people in the country to have this unit. One of the radiologists in Spain has been using it for a while and has loved it. He has a lot of experience with it, but it’s really just picking up.

What do you think after having used it for a couple months?

Dr. Bennett: I think it’s great. It really has streamlined our process and made the biopsy procedure so much faster for our patients. It’s been really a great tool to have.

Honestly possibly answers that day as opposed to a week.

Dr. Bennett: That depends on our pathology colleagues, yeah. We take out the samples, but generally speaking it takes them a few days to get an answer back because it’s a tough thing that they need to do.

How much faster could this be then for patients to get an answer?

Dr. Bennett: As opposed to a surgical biopsy, it’s usually about two or three days faster than the surgical biopsy.

 

END OF INTERVIEW

 

This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters. 

If you would like more information, please contact:

Jason Merrill

Public Relations Manager

314-989-3181

Jason.merrill@ssmsluh.com

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