MarginProbe® Shrinks Positive Margin Rates and Tissue Volume Removed for Both Invasive and DCIS Breast Cancers

Dr Vincent Reid is the Chairman of Surgery and Head of Surgical Oncology Services at Mercy Medical Center in Cedar Rapids Iowa. He also serves as Assistant Professor of Surgery at University of Iowa.

Dr. Reid is a firm believer in the success of MarginProbe in improving the results of breast cancer surgery. He was one of the first users of MarginProbe in the country, and he currently handles approximately 5 cases per week using MarginProbe.

Having completed over 250 cases using the MarginProbe system to date, Dr. Reid’s belief in the effectiveness of MarginProbe as part of the treatment regimen for both DCIS and invasive breast cancers is grounded in a study he conducted involving 54 cases utilizing the technology.

dr-vincent-reid

MarginProbe Results
As a bit of background, consider that breast conserving surgery frequently fails to achieve clear margins, leading to re-excision. Historically, high re-excision rates of 26% have been reported to obtain clear margins. Dr. Reid was using the full cavity shaving approach to reduce positive margins. “previously, when determining margins during surgery, I would take an x-ray image of the lump in the operating room,” explained Dr. Reid. “I would then consult with the radiologist and get their opinion on whether the margin is close or not based on the imaging. On top of that, I would need to shave additional margins to try and ensure success. But this process never worked exceedingly well much of the time, because depending on the orientation of the breast cavity, one margin may end up thicker than the other. What we were doing was a random excision of all the margins.”

Dr. Reid contrasted that with the results he experienced utilizing the MarginProbe system. In his study, the following results were obtained:

Re-excision Lumpectomy Procedures Compared to Historical Set

Device SetHistorical SetReductionP-Value
Re-excision procedures3.7% (2/54)15.1% (19/119)75%0.038

This table provides a comparison of re-excision procedures between the device set and the historical set. With use of the MarginProbe, the re-excision rate was 3.7% (2/54), in comparison to 15.1% (19/119) in the Historical set. This constitutes a significant 75% relative reduction in the rate of re-excision procedures.

Differences in Tissue Volume of the Shavings, in Comparison to a Full-Cavity Shaving Approach

Volume of tissue removed by shavings in the device set vs. tissue volume of shavings with full cavity shaving-20cc
Volume of shavings removed (relative to main specimen volume), in comparison to full cavity shave approach-40%

This table shows the modeling of the differences in tissue volume removed. The tissue volume removed by additional shavings in the device set was 20cc less, in comparison to the shavings volume when performing full cavity shaving. This difference amounted to a 40% relative reduction in the volume of tissue in the shavings, relative to the main specimen volume.

The MarginProbe Difference
“In comes MarginProbe, and we are now able to check the tissue intraoperatively,” continued Dr. Reid. “MarginProbe gives me the ability to not blindly take all the margins. Based on MarginProbe criteria, we determine what margins are positive or close. We can then do a directed shaving on just the margins that need it. Before, I might have taken 6 margins randomly. Now, I’m taking 2-3 margins. As I’m taking less margins the overall volume of tissue removed is less.”

Dr. Reid discusses MarginProbe with patients during the informed consent part of the visit. But he finds that many patients already know about it the system due to its reputation and through the patient’s own research. “Re-excision results in costs to the patient and costs to the institution,” he said. “It also impacts cosmetic outcomes. Patients often understand this, so when I provide patients with the national re-excision rate, and I provide them with my own re-excision rate, both before and after using MarginProbe, they see the value of this approach.”

MarginProbe in Daily Practice
Dr. Reid shared a specific example of the day-to-day benefit that MarginProbe can provide. “I had a patient just the other day with a cancer that would normally require a mastectomy, but she did not want a mastectomy,” he explained. “She was at the upper limit of where we would do a lumpectomy, but I was still comfortable with proceeding due to MarginProbe.”
“During the surgery, the MarginProbe did identify a positive margin that I feel I would have missed with an x-ray,” he continued. “With MarginProbe, I was able to remove that margin and avoid a second surgery—which is a big deal.”

Why is it “a big deal?” Dr. Reid cited reasons such as saving patient time, money and headaches that are associated with having to submit to another surgical procedure. But he feels there is another reason that is much, much more important to a patient’s overall sense of well-being. “I think an important point to note is the psychological impact of telling a patient you have to go back for an additional surgery,” he explained. “It doesn’t matter if it’s a quick operation or that the additional tissue to be removed is small. Once you tell a patient that they have to go back in for re-excision, all they hear is, ‘I still have cancer.’”

“A significant portion of these patients will insist on having a mastectomy, even if that option is really overtreatment,” he continued. “The peace of mind of knowing the cancer was removed the first time, outside of the clinical data, is worth the cost of using MarginProbe.”

The Future of MarginProbe
Dr. Reid is currently evaluating MarginProbe’ effectiveness when used in concert with DaVinci®, a robotic surgical system that promises a much less invasive approach to breast cancer surgery. Potential benefits of DaVinci include:
– Significantly less pain
– Less blood loss
– Less scarring
– Shorter recovery time
– Faster return to normal daily activities

So far, Dr. Reid has found no negative impact using this technology with MarginProbe. “If there is something new that can positively impact patient outcomes, including both the clinical oncology and cosmetic outcomes, I think it’s important to be able to offer that technology to your patients,” he declared.

The MarginProbe Bottom Line for Surgeons
“When you have something that’s been proven as MarginProbe has, with several studies showing the positive impact, and with no downside that I can think of, you really need to give me a reason not to use it,” stated Dr. Reid. “This is a device we can use onsite and it doesn’t even touch the patient. It adds only 10 minutes to operative time, it’s easy-to-use and it’s not cumbersome. It has positive clinical and oncological impact—you add up all of this and if you’re concerned about the wellbeing of your patient, I really cannot think of a reason not to use it.”

Vincent Reid, MD, FACS
– Head of Surgical Oncology Services at Mercy Medical Center in Cedar Rapids Iowa
– Assistant Professor of Surgery at University of Iowa
– Specialist in head and neck cancers, breast cancer, melanoma, colon and rectal cancers and soft tissue sarcomas

Mercy Medical Center
– 2100 employees
– Formally designated as a Planetree Gold Designated® Person-Centered Organization
– One of Health Care’s Most Wired hospitals, according to the results of the 18th Annual Health Care’s Most Wired® survey, released by the American Hospital Association’s (AHA) Health Forum

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