Evaluation of the SmartClip™ Nonradioactive Seed, a Novel Wireless Localization Method for the Breast: Initial Clinical Experience and Surgical Outcome.

Introduction: Wire localization has been the gold standard for breast localization of non-palpable lesions for decades. This technique remains robust but has disadvantages relative to scheduling, complications of vasovagal reactions in placement, wire migration, or transection. With more modern technologies available, several implantable markers have been developed to allow uncoupling of localization by radiology and the surgical procedure on the same day. This study summarizes our experience with the EnVisio Navigation System™ utilizing SmartClip™ as the implantable tissue localization marker.

Methods: An IRB-approved retrospective database of benign and malignant breast disease was used to perform a review of 100 consecutive patients who underwent SmartClip™ localized breast and axillary procedures in 2021. Demographic information, localization accuracy, associated surgical procedure(s) with resultant pathology findings, margin status for malignancies, and re-excision rate were collected.

Results: The localized breast lesion or lymph node was excised and SmartClip™ retrieved in all cases, confirmed by intraoperative specimen radiograph. The distribution of gender and race/ethnicity among the patients who underwent surgery reflects the community population and frequency of breast cancer development among men versus women. 45.1% of the cases involved malignancy, as determined pre-operatively. Positive margins requiring re-excision constituted 18.2% of cases. In twenty-six patients, two or three SmartClips™ were placed per case for either a bracketed lesion, two separate breast lesions, and/or a breast lesion and lymph node.

Conclusion: Although this study is limited in patient number, it demonstrates safety of this technique and its reliability in guiding the surgeon directly to the lesion(s) of concern.