Abstract P4-03-01: Analysis of the impact of intraoperative margin assessment with adjunctive use of MARGINPROBE® vs. standard of care on margin status with different definitions of positive margin depth, results from a randomized prospective multi center study

Author(s):  
M Gittelman
2018 ◽  
Vol 91 (2) ◽  
pp. 197-202
Author(s):  
Maria Mihaela Pop ◽  
Silviu Cristian ◽  
Orsolya Hanko-Bauer ◽  
Dana Valentina Ghiga ◽  
Rares Georgescu

Background and aim. The purpose of breast-conserving surgery (BCS) for women with cancer is to perform an oncological radical procedure with disease-free margins at the final histological assessment and with the best aesthetic result possible. Intraoperative resected specimen ultrasound and intraoperative resected specimen mammography may reduce the rates of positive margins and reexcision among patients undergoing conserving therapy. Our objective is to compare the two methods with the histopathological  results for a preset cut off and asses which parameters can influence the positive margin status.Method. A prospective study was performed on 83 patients who underwent breast conservation surgery for early breast cancer (pT1-3a pN0-1 M0) between 2014 and 2016. After excision the specimen was oriented in the operating room by the surgeon. Metallic clips and threads were placed on margins: one clip and the long thread at 12 o'clock, two clips and the short threads at 9 o'clock. The next step was intraoperative ultrasound assessment of the specimen. For the margins under 2 mm we performed selective margin shaving, followed by mammography to identify and document the lesion and finally histopathological examination of the specimen with reporting the gross and microscopic margins. The positive margins required re-excision or boost of radiation at the posterior or anterior margins, depending on the case.Results. We set a cut-off at 2 mm. The sensitivity and specificity of the intraoperative margin assessment via the ultrasound method were 90.91% (95% CI 70.84-98.88%) and 67.21% (95% CI 54-78.69%) respectively. The sensitivity and specificity of the intraoperative margin assessment via the mammographic procedure were 45.45% (95% CI 24.39-67.79%) and 85.25% (95% CI 73.83-93.02%) respectively. There was positive correlation between the histopathological and intraoperative ultrasound exam (p=0.018) and negative correlation between the histopathological exam and the post-operative mammographic exam (p=0.68). We found a positive correlation between the positive margin status and age (<40), preoperative chemotherapy, intraductal carcinoma, inflammatory process around the tumor, and the immunohistochemical triple negative profile.Conclusions. According to our results, the intraoperative ultrasound of the breast specimen for a cutt-off at 2 mm can decrease the rates of margin positivity compared to the mammographic procedure and has the potential to diminish the number of subsequent undesired re-excisions.


2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 79-79 ◽  
Author(s):  
Mary L. Sebastian ◽  
Alice Marie Police ◽  
Stephanie Akbari ◽  
Beth Anglin

79 Background: Historically there has been a high rate of surgical interventions to obtain clear margins for breast cancer patients undergoing breast conserving local therapy. This study is the first compellation of data among three breast centers to assess the impact of an intraoperative margin assessment tool (MarginProbe) on re-excision rates. This device has been approved for clinical use in the United States since 2013. We present groups of consecutive patients in each of these breast centers – before and after the implementation of routine intraoperative use of the margin assessment device during lumpectomy procedures. Methods: 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 imaged intra-operatively by X-ray, and additional shavings were taken if needed based on clinical assessment. We established the historical re-excision rates of each surgeon on a consecutive set of patients in a corresponding period just before we began using the device. Results: In total, 165 patients were treated in three institutions up until April 2014. Sixteen patients (9.7%, 16/165) required re-excision. Historical re-excision rates corresponding to periods of use before the intraoperative margin assessment device was put into use were 25.8% (48/186). The re-excision rate was reduced by 62% (P<0.0001). Six re-excisions were due to a positive shaving which was not measured by the device. Conclusions: 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.


2018 ◽  
Vol 36 (5) ◽  
pp. 783-788 ◽  
Author(s):  
Burkhard Ubrig ◽  
Alexander Roosen ◽  
Christian Wagner ◽  
Guenter Trabs ◽  
Frank Schiefelbein ◽  
...  

Author(s):  
Kaitlin F. Mitchell ◽  
Erin McElvania ◽  
Meghan A. Wallace ◽  
Lauren E. Droske ◽  
Amy E. Robertson ◽  
...  

Background: Members of the genus Corynebacterium are increasingly recognized as pathobionts and can be very resistant to antimicrobial agents. Previous studies have demonstrated that Corynebacterium striatum can rapidly develop high-level daptomycin resistance (HLDR) (minimum inhibitory concentration [MIC] ≥256 μg/mL). Here we conducted a multi-center study to assay for this in vitro phenotype in diverse Corynebacterium species. Methods: Corynebacterium clinical isolates (n=157) from four medical centers were evaluated. MIC values to daptomycin, vancomycin, and telavancin were determined before and after overnight exposure to daptomycin to identify isolates able to rapidly develop daptomycin non-susceptibility. To investigate assay reproducibility, 18 isolates were evaluated at three study sites. In addition, stability of daptomycin non-susceptibility was tested using repeated subculture without selective pressure. The impact of different media brands was also investigated. Results: Daptomycin non-susceptibility emerged in 12 of 23 species evaluated in this study (C. afermentans, amycolatum, aurimucosum, bovis, jeikeium, macginleyi, pseudodiphtheriticum, resistens, simulans, striatum, tuberculostearicum, and ulcerans) and was detected in 50 of 157 (31.8%) isolates tested. All isolates displayed low (susceptible) MIC values to vancomycin and telavancin before and after daptomycin exposure. Repeated subculture demonstrated 2 of 9 isolates (22.2%) exhibiting HLDR reverted to a susceptible phenotype. Of 30 isolates tested on three media brands, 13 (43.3%) had differences in daptomycin MIC values between brands. Conclusions: Multiple Corynebacterium species can rapidly develop daptomycin non-susceptibility, including HLDR, after a short daptomycin exposure period.


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