Analysis of the Impact of Intraoperative Margin Assessment with Adjunctive Use of MarginProbe versus Standard of Care on Tissue Volume Removed

Breast conserving surgery has been accepted as the optimal local therapy for women with early breast cancer, emphasizing the necessity to balance oncologic goals with patient satisfaction and cosmetic outcomes. In the move to enhance a surgeon's ability to achieve histologically clear margins intraoperatively at the initial surgery, the MarginProbe (Dune Medical Devices, Caesarea, Israel) has emerged as an effective tool to accomplish that task. Based on previously reported success using the device, we assessed cosmesis and tissue resection volumes among participants in a randomized-controlled trial comparing the standard of care lumpectomy performed with and without the MarginProbe. The use of the MarginProbe device resulted in a 57% reduction in reexcision rates compared to the control group with a small increase in tissue volume removed at the primary lumpectomy. When total tissue volumes removed were analyzed, the device and control groups were still very similar after normalization to bra cup size. We concluded that the MarginProbe is an effective device to assist surgeons in determining margin status intraoperatively while allowing for better patient cosmetic outcomes due to the smaller volumes of tissue resected and the reduction in patient referrals for second surgeries due to positive margins.