H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Ann Surg Oncol. 2023 Nov;30(12):7081-7090. doi: 10.1245/s10434-023-13976-5. Epub 2023 Aug 8.
SmartClip is a food and drug administration-approved, electromagnetic chip (EMC) localization system that provides three-dimensional navigation for the excision of soft tissue lesions. The purpose of this study was to analyze the accuracy and feasibility of EMC radiologic and surgical localization for benign and malignant breast lesions.
An institutional review board-approved, single institution, prospective study from October 2020 to September 2022 of 38 women undergoing breast conserving surgery with EMC localization of a single lesion > 5 mm on mammogram (MMG) or ultrasound (US) imaging. Surveys from performing breast radiologists and breast surgeons were collected after image-guided localization and surgical excision.
Seventy-six survey responses from nine radiologists and four surgeons were received. The deployment needle and EMC were highly visible in 86.8% and 76.3% of procedures, respectively. There was no difficulty in deployment for 92.1% of procedures. The EMC was in the correct location on postdeployment MMG in 97.4% of cases. Three instances of EMC migration occurred, one 1 cm from target lesion. The targeted mass and EMC were within the surgical specimen in 97.4% of cases. On specimen radiograph, 39.5% of the EMCs were 0-1 mm from the center of the target lesion, 18.4% were within 2-4 mm, and 23.7% were within 5-10 mm. Mean operating room time for all cases was 65 min. One case required US to localize the target due to console malfunction.
There was successful EMC deployment by radiologists with accurate visualization and successful surgical excision in most cases. The EnVisio SmartClip system is a reproducible and accurate localization method for benign and malignant breast lesions.
SmartClip 是一款获得美国食品药品监督管理局批准的电磁芯片（EMC）定位系统，可为软组织病变的切除提供三维导航。本研究旨在分析 EMC 影像学和手术定位在乳腺良、恶性病变中的准确性和可行性。
这是一项于 2020 年 10 月至 2022 年 9 月在一家机构进行的回顾性、单中心、前瞻性研究，共纳入 38 例行保乳手术且 EMC 定位的单病灶>5mm 的女性患者，这些病灶在乳腺 X 线摄影（MG）或超声（US）图像上可见。在图像引导定位和手术切除后，收集了进行乳腺放射科医师和乳腺外科医师的调查。
共收到 9 名放射科医师和 4 名外科医师的 76 份调查答复。在 86.8%和 76.3%的病例中，置针和 EMC 均高度可见。92.1%的病例置针无困难。在术后 MG 上，EMC 位于正确位置的比例为 97.4%。有 3 例 EMC 发生迁移，其中 1 例距离目标病灶 1cm。在 97.4%的病例中，目标肿块和 EMC 均位于手术标本内。在标本 X 线片上，39.5%的 EMC 距离目标病灶中心 0-1mm，18.4%位于 2-4mm 内，23.7%位于 5-10mm 内。所有病例的平均手术室时间为 65min。有 1 例因控制台故障需要 US 定位目标。
放射科医师能够成功进行 EMC 置针，大多数病例均可实现准确可视化和成功切除。EnVisio SmartClip 系统是一种用于乳腺良、恶性病变的可重复、准确的定位方法。
