Intact Excision of Breast Lesions Using BLES™: Is There a Clinical Indication Yet?

Excerpt

In this issue of Annals of Surgical Oncology, Whitworth et al.1 report their data from their Intact Percutaneous Excision (IPEX) Registry. In a prospective study, 124 cancer patients (both invasive and noninvasive) and 160 patients with high-risk breast lesions (HRLs) underwent a minimally invasive (MI) resection of their lesions using the Intact Breast Lesion Excision System (BLES™; Medtronic Inc., Dublin, Ireland). BLES uses a 15 or 20 mm vacuum and radiofrequency biopsy device to remove mammographic lesions en masse. This is the second study by Whitworth et al. to examine the BLES device. In 2011,2 1170 patients at 25 institutions underwent IPEX with the BLES device. Eighty-three patients (7%) had an HRL and 191 (16%) had carcinoma. Only 32 patients had atypical ductal hyperplasia (ADH), of whom 9.4% were upgraded to carcinoma after surgical excision. None of the 51 patients with non-ADH HRL had an upgrade. In this current study, the authors examined their results with cancers < 20 mm and HRLs. The study examined the short-term goals of tumor upgrade or tumor-positive margins; follow-up was not long enough to establish the efficacy of BLES for cancer. Of 124 cancer patients, 55% had clear margins after undergoing a biopsy with the BLES device, 27% underwent another procedure with the BLES device to establish negative margins, and 18% underwent surgical excision of their cancer because they did not fulfill pathology and radiology criteria with IPEX. Therefore, amongst those who fulfilled IPEX criteria, 33% still had tumor positive margins and required another  procedure to get negative margins. Of 88 HRLs, only two (2.4%) had subsequent upgrade to ductal carcinoma in situ (DCIS) on subsequent surgical excision. Furthermore, of 72 HRLs that fulfilled the criteria for MI resection, no further resection was performed, therefore tumor upgrade could not be assessed. …