OBJECTIVE: A prospective, phase IV study was conducted to assess the effectiveness of Magseed to localize breast lesions requiring surgical excision. BACKGROUND: Since FDA approval in 2016, Magseed has been increasingly used to localize non-palpable lesions due to advantages over wires or radioactive seeds. This is the first prospective, post marketing trial of Magseed. METHODS: From 1/2017-2/2018, 107 women with lesions requiring localization were enrolled at a single institution. Primary endpoint was Magseed retrieval rate. Secondary endpoints were adverse events, accuracy of placement, surgery duration and positive margin rate. Clinicians were surveyed for ease of use using a Likert scale. Descriptive statistics and Fisher's exact test were performed to assess univariable associations with positive margins. RESULTS: There were 124 Magseeds placed including one marker in 93 subjects, 2 markers in 11 and 3 markers in 3. The majority of lesions were masses (63%) followed by calcifications (24%). All 124 Magseeds were placed within 10mm of the target lesion and surgically retrieved with median operative time of 15min (range 4-47). No device-related adverse events occurred. Of the 98 malignant lesions, 9 had positive margins and 7 of them underwent a second surgery for additional margins. On univariable analysis, age ≤ 50 (25.0% vs 6.4%, p=0.04), lesion histology (p = 0.03), and pathologic T-stage (p = 0.04) were significantly associated with positive margins. Clinicians rated the Magseed very or fairly easy to use in most cases. CONCLUSIONS: The Magseed system for localization of non-palpable lesions was effective and safe; all markers were successfully retrieved with margin-negative resections in 91%. This study supports use of Magseed for localization of breast lesions.
OBJECTIVE: A prospective, phase IV study was conducted to assess the effectiveness of Magseed to localize breast lesions requiring surgical excision. BACKGROUND: Since FDA approval in 2016, Magseed has been increasingly used to localize non-palpable lesions due to advantages over wires or radioactive seeds. This is the first prospective, post marketing trial of Magseed. METHODS: From 1/2017-2/2018, 107 women with lesions requiring localization were enrolled at a single institution. Primary endpoint was Magseed retrieval rate. Secondary endpoints were adverse events, accuracy of placement, surgery duration and positive margin rate. Clinicians were surveyed for ease of use using a Likert scale. Descriptive statistics and Fisher's exact test were performed to assess univariable associations with positive margins. RESULTS: There were 124 Magseeds placed including one marker in 93 subjects, 2 markers in 11 and 3 markers in 3. The majority of lesions were masses (63%) followed by calcifications (24%). All 124 Magseeds were placed within 10mm of the target lesion and surgically retrieved with median operative time of 15min (range 4-47). No device-related adverse events occurred. Of the 98 malignant lesions, 9 had positive margins and 7 of them underwent a second surgery for additional margins. On univariable analysis, age ≤ 50 (25.0% vs 6.4%, p=0.04), lesion histology (p = 0.03), and pathologic T-stage (p = 0.04) were significantly associated with positive margins. Clinicians rated the Magseed very or fairly easy to use in most cases. CONCLUSIONS: The Magseed system for localization of non-palpable lesions was effective and safe; all markers were successfully retrieved with margin-negative resections in 91%. This study supports use of Magseed for localization of breast lesions.
Authors: Linnea Langhans; Tove F Tvedskov; Thomas L Klausen; Maj-Britt Jensen; Maj-Lis Talman; Ilse Vejborg; Cemil Benian; Anne Roslind; Jonas Hermansen; Peter S Oturai; Niels Bentzon; Niels Kroman Journal: Ann Surg Date: 2017-07 Impact factor: 12.969
Authors: Leslie R Lamb; Manisha Bahl; Michelle C Specht; Helen Anne D'Alessandro; Constance D Lehman Journal: AJR Am J Roentgenol Date: 2018-08-07 Impact factor: 3.959
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Authors: Elissa R Price; Amal L Khoury; Laura J Esserman; Bonnie N Joe; Michael D Alvarado Journal: AJR Am J Roentgenol Date: 2018-02-15 Impact factor: 3.959
Authors: Meena S Moran; Stuart J Schnitt; Armando E Giuliano; Jay R Harris; Seema A Khan; Janet Horton; Suzanne Klimberg; Mariana Chavez-MacGregor; Gary Freedman; Nehmat Houssami; Peggy L Johnson; Monica Morrow Journal: J Clin Oncol Date: 2014-02-10 Impact factor: 44.544
Authors: Benjamin K Y Chan; Jill A Wiseberg-Firtell; Ramesh H S Jois; Katrin Jensen; Riccardo A Audisio Journal: Cochrane Database Syst Rev Date: 2015-12-31
Authors: Monica Morrow; Kimberly J Van Zee; Lawrence J Solin; Nehmat Houssami; Mariana Chavez-MacGregor; Jay R Harris; Janet Horton; Shelley Hwang; Peggy L Johnson; M Luke Marinovich; Stuart J Schnitt; Irene Wapnir; Meena S Moran Journal: Ann Surg Oncol Date: 2016-08-15 Impact factor: 5.344