CHOOSE YOUR WEAPON

In the battle against breast cancer, today?s physicians can choose from an array of image-guided breast biopsy options and tools.

It has been suggested that physicians show specialty bias. For instance, a surgeon is more likely to opt for a surgical biopsy, while a radiologist will tend to choose an image-guided procedure. And they both will have supporting reasons. Given the choice of surgery or a minimally invasive procedure, however, many patients would likely opt for the latter, but the decisions don’t end there.

Radiologists also must decide between the various methods available for image-guided procedures. What type of imaging modality should be used? What type of biopsy? What size needle would be best?

“Essentially, it is the physician’s choice, and different physicians have different criteria,” said Terri-Anne Gizienski, MD, director of breast imaging at Magee Women’s Hospital of Cranberry, part of the University of Pittsburgh Medical Center (UPMC), in Cranberry, Pa.

Part of the decision will be technical: with which method is the physician most comfortable? On what tools have they been trained? “Physicians like routine—certainly, I’m no different. So it can be challenging to get them to try different tools, but it’s important for facilities to have different options and for physicians to be comfortable with them,” Gizienski said.

Many facilities offer different modalities and methods, but a wide variety of tools can be difficult to achieve. Cost is always an issue. “We obviously have to be aware of the size of the cost differential. Does it make sense to offer many varieties, or can we streamline it and offer maybe only one or two?” Gizienski said. And then which one or two?

The Best View

Physicians can conduct image-guided breast biopsies via a number of modalities, including stereotactic imaging, MRI, and ultrasound. “This decision is made based on the way you see the lesion best,” said Stacey Vitiello, MD, a breast imaging specialist at Montclair Breast Center in Montclair, NJ.

If a stereotactic or MRI device will be used, the biopsy is typically a vacuum-assisted procedure using a large-gauge needle. “For ultrasound-guided procedures, there is a little more variability in the biopsy types that people choose to use,” Vitiello said.

The options can include fine needle aspiration (FNA), core needle biopsy, and vacuum-assisted biopsy. “When people first started doing percutaneous needle biopsies with ultrasound guidance, most physicians were using a needle and a syringe and doing a fine needle aspiration biopsy. But over the years, at most centers in the country, the larger core biopsy needle or vacuum-assisted biopsy is used because the FNA has a pretty high frequency of insufficient tissue being sampled,” Vitiello said.

FNA: Valued, But Not a Biopsy Favorite

This does not mean that fine needle aspiration has no value; there are benefits to be realized from the procedure. It’s easy and inexpensive, and can provide an immediate answer. “The FNA can be used for proving that something is or is not a cyst. If it aspirates out, it’s a cyst,” Vitiello said.

As a biopsy tool, though, many physicians find it unreliable. “With fine needle aspiration, you often can get inconclusive results, and you need a good cytopathologist to interpret the results, so the patient may need a repeat biopsy,” Gizienski said.

In addition, there is often a risk of insufficient tissue being collected, precluding the ability to run genetics tests for neuromarkers and receptors. “FNA does not allow those studies to be performed,” said Vitiello.

Many physicians decide to avoid the procedure altogether. Manfred Henne, MD, PhD, MS, the owner physician of InHealth Imaging in Poulsbo, Wash, is one such doctor. “I don’t do fine needle aspiration at all,” Henne said.

Capturing the Lesion

Instead, Henne prefers to perform either a core needle or vacuum-assisted biopsy, depending on the size of the lesion. “I use a standard core biopsy if the lesion is a good size so I have an assurance that I can safely core biopsy in the lesion. If the lesion is small, then I prefer the vacuum-assisted [biopsy] because I get a larger sample, and I can sample the area more times with greater assurance that I’ve got the lesion,” Henne said.

Many physicians agree, feeling that the underestimation of disease is greater with core needle biopsies than vacuum-assisted, but some feel they can do everything they need using a core needle method.

Vitiello has discussed the issue with the laboratory that performs the tissue marker tests for the Montclair Breast Center. “They noted it’s very rare for either biopsy, either the 14-gauge core or 11-gauge vacuum-assisted, to not provide enough tissue to send for markers. But on the rare occasion [it does occur], they estimated it may be 2% or 3% of the cancer that they see, and that during those events, they said, it’s equally as common for the 14-gauge to not yield enough tissue as opposed to the vacuum-assisted biopsy,” Vitiello said.

Published studies have found mixed results. “There have been reports in the scientific literature that vacuum biopsies have fewer false negatives than core biopsies, but the group I trained with at Yale in 2003 wrote a paper showing there was no difference in the false-negative rates between the two different kinds of biopsies,” Vitiello said.

However, consistent success using a core needle may be due in part to physician comfort, skill, and technique. Depending on the device used, the core needle may demand control of throw. In addition, multiple insertions are typically required, increasing the need for practiced skill: physicians need to be careful that they do not violate the chest wall but do get the needed sample.

“Experience has a large role to play in the success of a needle biopsy. If someone is very good at being able to shoot the target, then they’re going to have a much lower false-negative rate no matter which device they use,” Vitiello said.

Gizienski feels that needle size also may play a role in the success of obtaining sufficient sample using a core needle. “As the gauge of your needle increases, the chances that you may miss diagnosing a positive lesion that is early cancer versus invasive cancer also increases,” Gizienski said.

Size Matters

Core needle biopsies generally use a smaller needle than those used in vacuum-assisted procedures. Vitiello estimates that a regular core biopsy gun uses needles that range in size from 12-gauge to 18-gauge. “My favorite is the 14-gauge needle, but I also get very good tissue samples using a 16-gauge,” Gizienski said.

Vacuum-assisted devices also offer a choice in needle sizes, typically 9-gauge, 11-gauge, and newer 14-gauge needles. The larger needles contribute to the method’s success in obtaining sufficient samples for accurate diagnosis and additional testing.

“If the size of the lesion is small or it’s a subtle area of abnormality on the ultrasound, I tend to perform a vacuum-assisted biopsy because I want to be sure that I’m getting the area I was concerned about and am more confident with the vacuum device,” Vitiello said.

However, the equipment takes up a larger footprint and can be intimidating. Vacuum-assisted biopsy devices are larger in general than those used to collect a core needle sample and feature significant tubing and sound. “I think handheld vacuum-assisted units for ultrasound biopsies that don’t have to be hooked up to large machines or canisters are promising, and a couple of companies have developed such products,” Vitiello said. She has found one of the devices performs well; the other will benefit with continued development.

Another disadvantage with vacuum-assisted biopsies, for some, is that they generally require more time than core needle procedures to set up on the part of whoever is assisting with the procedure, whether a technologist, nurse, or other staff member. However, this time can be reduced to an insignificant difference.

“If you’re consistent in how you approach biopsies and do not have to ‘reinvent the wheel’ every time, it often makes it easier for the physician and whoever is assisting so that over time, it doesn’t take much longer to set up a vacuum-assisted procedure,” Gizienski said.

Patient Factors

The setup time is not a major concern for Vitiello, but she will often opt for a core needle biopsy if the clinical criteria allow it so she creates a less intimidating experience for the patient. The vacuum-assisted machine, its sound, and the large needle are often scarier than the core biopsy gun. “Patients tolerate [the core needle procedure] a little bit better,” Vitiello noted.

A smaller needle is also less likely to create a hematoma or leave a large scar. However, these concerns pale if the clinical need exists for a larger gauge. “You may have a few more hematomas using a larger needle and you should be aware of the risk, but in looking at the overall picture and what’s best for the patient, which is worse—to capture the cancer and leave them a little bruised or miss the cancer?” Gizienski said.

Hematomas are a particular concern for patients on aspirin or other blood thinners. Some physicians will wait a week or so for the patient to get off the medication, but if time is pressing, careful technique can also help to reduce the risk. “If you’re very diligent about holding pressure and how you’re taking care of the patient even after the biopsy, you can minimize the risks of increased bruising [associated with] using a larger needle,” Gizienski said.

Patient comfort also can be moderated through the use of adequate local anesthetic, which can make any of the procedures more comfortable, according to Vitiello. “I think clinicians don’t always take enough time to be sure that the patients are very comfortable, and that care may lead to a negative experience for the patient impacting future biopsies. I think we can very easily address this position by being more generous with our anesthetic,” Vitiello said.

The Right Choice

Patient care and comfort will often take precedence over other concerns, such as the economics behind the care, but these concerns can play a role in the decision to offer a specific procedure. Some facilities may limit their options, perhaps offering a smaller selection of tools and vendors—”vendors like to have exclusive contracts,” Vitiello says—but variability is key.

“My theory is one size does not fit all. I did a patient today who was 100 years old and had a very large tumor that was presumably cancer, so I didn’t need to vacuum biopsy that or use a very large needle. But if I’m going after a very small—maybe a 4 mm cancer—then, in my case, I do want to use a larger needle so I don’t miss it,” Gizienski said.

The right choice will save money over the long term through adequate sampling, accurate diagnosis, and appropriate time. In the short term, there are differences in cost and reimbursement. Vacuum-assisted biopsy devices cost more than core needle biopsy tools, which is passed on to patients. “Just the needle for the vacuum device—which gets thrown away when the procedure is done—is several hundred dollars,” Vitiello said.

However, Medicare does reimburse for vacuum procedures at a higher rate: $1,200 for vacuum-assisted versus $550 for a core biopsy, according to Vitiello. Vacuum-assisted procedures also may perform double-duty.

“Vacuum-assisted biopsy can offer removal of certain benign lesions without sending the patient to the operating room where you’re talking about more cost, putting the patient under anesthesia, and scarring. With the percutaneous vacuum-assisted biopsy, you can do it right in the office with local anesthetic. There’s no scarring, and the patients don’t feel that lump afterwards,” Gizienski said.

Ultimately, the choice made is about what is best for the patient, and so it is good to have choices. Options cover the gamut, from modality and biopsy procedures to specific tools and needle sizes. “In general, if you can get the diagnosis and the samples you need with a less expensive and less intimidating procedure, that makes the most sense to me. But I like having the option of vacuum-assisted biopsy in certain circumstances—and other people would completely disagree with me,” Vitiello said.

Physicians might show a little specialty bias, preferring to use procedures and tools that they know, but this, too, is good for the patient. A more practiced hand will tend to be more successful. Different physicians will have different criteria, but essentially, it is the physician’s choice.

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Renee Diiulio is a contributing writer for Axis Imaging News.