title: The impact of use of an intraoperative margin assessment device on re-excision rates.
abstract: Historically there has been a high rate of surgical interventions to obtain clear margins for breast cancer patients undergoing breast conserving local therapy. An intraoperative margin assessment tool (MarginProbe) has been approved for use in the US since 2013. This study is the first compilation of data from routine use of the device, to assess the impact of device utilization on re-excision rates. We present a retrospective, observational, review from groups of consecutive patients, before and after the implementation of intraoperative use of the device during lumpectomy procedures. Lesions were localized by standard methods. The intraoperative margin assessment device was used on all circumferential margins of the main specimen, but not on any additional shavings. A positive reading by the device led to an additional shaving of the corresponding cavity location. Specimens were also, when feasible, imaged intra-operatively by X-ray, and additional shavings were taken if needed based on clinical assessment. For each surgeon, historical re-excision rates were established based on a consecutive set of patients from a time period proximal to initiation of use of the device. From March 2013 to April 2014 the device was routinely used by 4 surgeons in 3 centers. In total, 165 cases lumpectomy cases were performed. Positive margins resulted in additional re-excision procedures in 9.7% (16/165) of the cases. The corresponding historical set from 2012 and 2013 consisted of 186 Lumpectomy cases, in which additional re-excision procedures were performed in 25.8% (48/186) of the cases. The reduction in the rate of re-excision procedures was significant 62% (P < 0.0001). Use of an intraoperative margin assessment device contributes to achieving clear margins and reducing re-excision procedures. As in some cases positive margins were found on shavings, future studies of interest may include an analysis of the effect of using the device on the shavings intra-operatively.
authors.affiliation: Virginia Hospital Center, Reinsch Pierce Family Center for Breast Health, 1625 N George Mason Dr, Arlington, VA 22205 USA.
authors.forename: Molly
authors.initials: M
authors.lastname: Sebastian
authors.affiliation: Virginia Hospital Center, Reinsch Pierce Family Center for Breast Health, 1625 N George Mason Dr, Arlington, VA 22205 USA.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Akbari
authors.affiliation: Medical Center of Plano, Complete Breast Care, 3801 W. 15th Street Building A, Suite 210, Plano, TX 75075 USA.
authors.forename: Beth
authors.initials: B
authors.lastname: Anglin
authors.affiliation: Department of Surgery, University of California Irvine Medical Center, 333 City Blvd. West, Suite 1600, Orange, CA 92868 USA.
authors.forename: Erin H
authors.initials: EH
authors.lastname: Lin
authors.affiliation: Department of Surgery, University of California Irvine Medical Center, 333 City Blvd. West, Suite 1600, Orange, CA 92868 USA.
authors.forename: Alice M
authors.initials: AM
authors.lastname: Police