SAVI SCOUT®

What is Breast-Conserving Surgery (BCS)

The goal of breast cancer surgery is to remove cancer from the breast and determine the stage of disease. As recently as the 1980s, the standard treatment for women diagnosed with breast cancer was a mastectomy, or removal of the whole breast, sometimes including lymph nodes. Thanks to technological advances in detection and new treatment approaches, most women have the option to save their breasts by choosing breast-conserving surgery (BCS).

With BCS, only cancerous tissue, plus a rim of normal tissue, is removed during a lumpectomy procedure. How much breast tissue is removed depends upon the size and location of the tumor. Research has shown that BCS followed by radiation therapy is as effective as a mastectomy in decreasing the risk of local cancer recurrence for most women.

BCS Techniques: Wire Localization

Overview

Prior to 2015, surgeons generally relied on wire localization (WL) to locate a tumor during breast-conserving surgery. With wire localization, a radiologist guides a thin, hooked wire through the skin to the lesion. The surgeon then uses the wire to help guide the removal.

 

Challenges of Wire Localization

  • The wire must be placed the same day as the lumpectomy procedure, which requires a high degree of coordination between radiology and surgical schedules. Not only can this lead to costly delays in the operating room, it often forces women to wait long periods of time with a wire protruding from their breast.
  • Many patients are unnerved by wires hanging out of their breasts, especially when they have to transport themselves from radiology to the operating room.
  • Wire kinking, migration and/or displacement can occur before surgery, reducing the accuracy of finding the tumor and increasing the rate of local recurrence.
  • The ideal skin entry site for the wire is often distant from the ideal skin incision site for the surgeon, increasing the potential for less than optimal cosmetic outcomes.
  • If a wire is accidentally cut or dislodged during surgery, guidance to the tumor is lost, leading to a failed surgery or removal of excessive tissue.
  • Wire localization may result in inadequate removal of the cancer, requiring a second surgical procedure to remove more tissue.

BCS Techniques: SCOUT® Radar Localization System

In 2014, the SAVI SCOUT® radar localization system was cleared by the FDA for use by surgeons and radiologists to precisely locate and guide the removal of the target tissue during a lumpectomy or surgical biopsy procedure.SCOUT® was developed to make breast cancer surgery easier for women and more efficient for the healthcare system.

The FDA-clearedSCOUT® system features radar to detect a reflector that is placed at the tumor site at any time during the continuum of care.  During surgery theSCOUT® system is used to detect the location of the reflector within the breast, allowing the surgeon to plan the best path to the tumor. SCOUT® then provides real-time distance measurement guidance to the target tissue during surgery. Finally, the system confirms that the reflector has been removed along with the targeted tissue.

 

Benefits of SCOUT® Radar Localization Over Wire Localization

  • The ability to place the reflector on a separate day can simplify the patient’s day of surgery, increasing convenience and lessening anxiety.
  • SCOUT® reflector is not externally visible after placement and will not restrict the patient’s daily activities
  • May minimize the patient’s wait time on the day of surgery.
  • SCOUT® provides guidance for precise tumor localization, which helps increase the likelihood of complete cancer removal and helps reduce the chances that the patient will need a second surgery.
  • The surgeon is able to plan the incision during surgery, which may allow for less tissue removal which can help result in better cosmetic results.

How does SAVI SCOUT® Work?

The SCOUT® wire-free radar localization system detects a reflector, smaller than a grain of rice, that can be placed into the target tissue at any time during the continuum of care.  The SCOUT® Reflector is the first and only non-radioactive implant used in wire-free breast tumor localization that has no restrictions on the length of time the reflector can remain in the breast.

During the surgical procedure (lumpectomy), the surgeon scans the breast using the SCOUT® guide, which emits 50 million pulses per second, to lock on to the reflector’s position. The SCOUT® Real-time Distance System is the only wire-free technology to offer 60mm detection range and 360° detection with ±1mm accuracy.

This more advanced level of localization precision allows better surgical planning that may improve cosmetic results, as less tissue may need to be removed.

Among women diagnosed with early-stage (I or II) breast cancer:

59 percent have breast-conserving surgery.

36 percent undergo a simple (total) mastectomy, which is the removal of the whole breast.

 

Among women diagnosed with late-stage (III or IV) breast cancer:

13 percent have breast-conserving surgery.

60 percent undergo a simple mastectomy.

Source: American Cancer Society. Cancer Treatment and Survivorship Facts & Figures, 2014–2015. Atlanta: American Cancer Society; 2014.

 

References

Progress & Timeline. (n.d.). Retrieved December 3, 2014, from http://www.cancerprogress.net/timeline/breast

NIH Fact Sheets – Breast Cancer. (n.d.). Retrieved December 3, 2014, from http://report.nih.gov/nihfactsheets/viewfactsheet.aspx?csid=73

Ferreira, L. (n.d.). More Breast Cancer Patients Are Choosing Mastectomy Surgeries, According to Study. Retrieved December 3, 2014, from http://breastcancer-news.com/2014/11/24/breast-cancer-patients-choosing-mastectomy-surgeries-according-study

Alderliesten, T., Loo, C., Pengel, K., Rutgers, E., Gilhuijs, K., & Marie-Jeanne T. F. D. Vrancken Peeters. (n.d.). Radioactive Seed Localization of Breast Lesions: An Adequate Localization Method without Seed Migration. The Breast Journal, 594-601.

Breast Cancer Statistics | Susan G. Komen.® (n.d.). Retrieved December 3, 2014, from http://ww5.komen.org/BreastCancer/Statistics.html

McCahill LE, Single RM, Aiello Bowles EJ, et al. Variability in Reexcision Following Breast Conservation Surgery. JAMA. 2012;307(5):467-475.doi:10.1001/jama.2012.43.

American Cancer Society. Breast Cancer Facts & Figures 2013-2014. Atlanta: American Cancer Society, Inc. 2013.