Elsevier

Clinical Imaging

Volume 52, November–December 2018, Pages 280-286
Clinical Imaging

Breast Imaging
SAVI SCOUT® localization of breast lesions as a practical alternative to wires: Outcomes and suggestions for trouble-shooting

https://doi.org/10.1016/j.clinimag.2018.07.008Get rights and content

Highlights

  • SAVI SCOUT® is successfully used for breast localizations in most cases.

  • Single excisions, bracketing and axillary lymph nodes are all amenable to SCOUT®.

  • The most common issue encountered was difficulty in obtaining an audible signal.

  • Audible signal difficulties are attributed to depth, hematoma or faulty reflector.

Abstract

Objective

The purpose of our study was to determine the frequency of successful SAVI SCOUT® localizations, to identify the factors contributing to unsuccessful procedures, and to provide a problem-solving algorithm to address those factors.

Subjects and methods

This retrospective study was performed following IRB approval. We included all consecutive patients with SCOUT® reflector placement performed at a single tertiary-care cancer center. Each case was reviewed and the following data were recorded: patient age, breast density, localization target, imaging modality used for guidance, post procedure mammogram reflector to skin and reflector to target distances, presence of the reflector in the specimen radiograph, excisional biopsy pathology and any procedure complications.

Results

In 129 women, 152 SAVI SCOUT® reflectors were placed. Most patients had only 1 reflector placed, but 19 (15%) women had multiple reflectors placed for the purposes of bracketing, multiple excisions in 1 breast, bilateral excisions, or any combination thereof. The most common target was a mass (65%) and the most common modality for guidance was ultrasound (73%). SAVI SCOUT® localization was successful in 97%of reflectors, including 89% of reflectors targeting axillary lymph nodes. The most common failure encountered was the inability to obtain a signal in the radiology suite, due to (1) excessive target depth for the radiology suite handpiece and console, (2) obscuration by a hematoma, or (3) faulty reflector. No post-operative complications occurred.

Conclusion

The SAVI SCOUT® surgical guidance system is an accurate and reliable method for localization of non-palpable breast lesions, bracketing, and axillary lymph nodes.

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.

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