Breast ImagingSAVI SCOUT® localization of breast lesions as a practical alternative to wires: Outcomes and suggestions for trouble-shooting☆
Introduction
Since the implementation of screening mammography in the 1980's, detection of non-palpable, early stage breast cancers has increased, and as such, so has breast conservation surgery [1]. Image guided wire localizations (WL) of nonpalpable breast lesions have been the mainstay of surgical excision since wire development in the 1970s [2]. However, several disadvantages of wire localizations include wire breakage/transection, wire migration, patient discomfort, discrepancy between wire entry site and preferred surgical approach, and, scheduling constraints due to wire placement coordination with the surgery time [[3], [4], [5], [6]]. In recent years, new devices have been developed to help overcome the disadvantages with WL, such as 125I-radioactive seed localizations (RSL), MagSeed®, and wireless radiofrequency identification (RFID) system [[5], [6], [7], [8]]. The most widely adopted alternative is RSL; however, seeds introduce radiation safety concerns, resulting in limited adoption of the technique [5, 6].
The SAVI SCOUT® surgical guidance system was approved by the U.S. Food and Drug administration in 2014. The methodology has been previously described in detail [[3], [4], [5], [6]]. Briefly, a nonradioactive infrared (IR)-activated electromagnetic wave reflector is implanted into the breast under imaging guidance. Because reflector deployment is similar to biopsy clip placement, very little training is required for the radiologist. The reflector is typically placed under ultrasound or mammographic guidance, and an audible signal from the implanted reflector is then detected percutaneously using the manufacturer's handpiece-and-console system [6].
At our institution, we implemented the SAVI SCOUT® infrared-activated electromagnetic wave reflector device placements as an alternative to wire placements. The purpose of our study was to measure the frequency of successful localization on nonpalpable breast lesions using SAVI SCOUT® as well as to identify factors contributing to unsuccessful procedures.
Section snippets
Methods & materials
This single-institution, retrospective study was Health Insurance Portability and Accountability Act compliant and Institutional Review Board approved. Patient informed consent requirement was waived. No financial support was provided from Cianna Medical (Cianna Medical, Aliso Viejo, CA). From our institutional database, we retrospectively identified all consecutive patients with SAVI SCOUT® reflector image guided placements and subsequent excision performed between November 2016 and August
Results
Of 524 image-guided localizations performed at our institution during the study time period, 152 (152/524 = 29%) reflectors were placed in 129 women (average age, 62 years; age range 33–90 years). The most common breast density was scattered fibroglandular (50%), followed by heterogeneously dense (38%), almost entirely fatty (11%) and extremely dense (1%). The majority (73%) of reflectors were placed with sonographic guidance due to radiologist preference, and a mass was the most frequent
Discussion
Previous studies have demonstrated the SAVI SCOUT® system to be a reliable substitute for WL or RSL excision of non-palpable breast lesions with successful reflector placement under sonographic guidance (32.5 to 64%) or mammographic guidance (36% to 67.5%) [[3], [4], [5], [6], 11]. In our study, SCOUT® localization was 97% successful, similar to the 90–100% reported frequencies of successful localizations using wire, RSL, or SCOUT® [[5], [6], [7], 12, 13]. Our study confirms the feasibility of
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This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Institutional review board approval was obtained for this retrospective study.