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Definitive diagnosis for high-risk breast lesions without open surgical excision: the Intact Percutaneous Excision
Pat W Whitworth1, Jean F Simpson, William R Poller
1Department of Surgery, Vanderbilt University School of Medicine, Nashville, TN, USA. patwhitworth@gmail.com
Insights
Intact percutaneous excision (IPEX) can definitively diagnose high-risk breast lesions (HRL), including atypical ductal hyperplasia (ADH). This approach, with specific criteria, allows for imaging surveillance, avoiding unnecessary surgery for most patients.
Area of Science:
- Breast imaging and pathology
- Minimally invasive breast procedures
- Oncology and surgical pathology
Background:
- Open surgical excision (OSE) is standard for high-risk breast lesions (HRL) found via biopsy.
- Intact percutaneous excision (IPEX) is evaluated for definitive HRL diagnosis, especially atypical ductal hyperplasia (ADH).
- The study aims to identify criteria for <2% upgrade risk to carcinoma, enabling imaging surveillance.
Purpose of the Study:
- To assess the efficacy of intact percutaneous excision (IPEX) for definitive diagnosis of high-risk breast lesions (HRL).
- To establish criteria for identifying patients with atypical ductal hyperplasia (ADH) who can avoid open surgical excision (OSE).
- To determine the upgrade risk to carcinoma for HRL diagnosed with IPEX.
Main Methods:
- A prospective trial involving 1,170 patients across 25 institutions used vacuum- and radiofrequency-assisted IPEX.
- Atypical ductal hyperplasia (ADH) patients were categorized into a potential surgical avoidance population (PSAP) based on lesion removal and centering.
- IPEX findings were compared with subsequent open surgical excision (OSE) pathology.
Main Results:
- IPEX diagnosed 191 carcinomas and 83 HRL (including 32 ADH) in 1,170 patients.
- No non-ADH HRL (n=51) were upgraded to carcinoma after IPEX.
- No ADH lesions meeting PSAP criteria (n=10) upgraded to carcinoma; 3 of 22 non-PSAP ADH lesions did upgrade.
Conclusions:
- IPEX, coupled with clear histologic and radiologic criteria, is a viable management option for image-detected HRL, including ADH.
- This approach allows for imaging surveillance in select cases, potentially reducing the need for open surgical excision.
- IPEX provides definitive diagnosis for HRL, enabling appropriate patient management pathways.
Background:
Open surgical excision (OSE) is generally recommended when image-guided core-needle breast biopsy demonstrates a high-risk lesion (HRL). We evaluated intact percutaneous excision (IPEX) with standard radiologic and histologic criteria for definitive diagnosis of HRL, particularly atypical ductal hyperplasia (ADH). The primary aim is to confirm criteria associated with <2% risk for upgrade to carcinoma, equivalent to risk associated with Breast Imaging Reporting and Data System (BI-RADS) 3 lesions, for which imaging surveillance is considered sufficient.
Methods:
In a prospective trial, 1,170 patients recommended for breast biopsy at 25 institutions received IPEX with a vacuum- and radiofrequency-assisted device. ADH patients in whom the imaged lesion had been removed and the lesion adequately centered for definitive characterization were designated as the potential surgical avoidance population (PSAP) before OSE. Subsequent OSE specimen pathology was compared with IPEX findings.
Results:
In 1,170 patients, 191 carcinomas and 83 (7%) HRL, including 32 ADH (3%), were diagnosed via IPEX. None of the 51 non-ADH HRL were upgraded to carcinoma on OSE (n = 24) or, if OSE was declined, on radiologic follow-up (n = 27). No ADH lesions meeting PSAP criteria (n = 10) were upgraded to carcinoma on OSE; 3 (14%) of 22 non-PSAP ADH lesions were upgraded to carcinoma on OSE. In summary, no upgrades to carcinoma were made in patients with non-ADH lesions who underwent IPEX or in ADH patients who had IPEX, met histologic and radiologic criteria, and underwent OSE or follow-up.
Conclusion:
IPEX combined with straightforward histologic and radiologic criteria and imaging surveillance constitutes acceptable management of image-detected HRL, including ADH.
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