Comparison of two visual localization biopsy methods for suspicious breast lesions under mammography: a multicenter cohort study

Introduction

According to the global cancer statistics released by the World Health Organization (WHO) in 2024, breast cancer is the most common malignant tumor threatening women’s health worldwide and the leading cause of cancer-related deaths among women (1). With the aid of mammography, microcalcification, as one of the significant signs of breast cancer, has significantly improved the detection rate of non-palpable breast lesions (2). Compared to traditional mammography, digital breast tomosynthesis (DBT), an advanced form of full-field digital mammography (DM), acquires images from multiple angles, effectively reducing the overlap of normal breast tissue and significantly enhancing the visibility of breast lesions (3-5). Another prominent advantage of DBT is its ability to accurately guide biopsies of non-palpable breast lesions, significantly improving the efficiency and accuracy of biopsies (6).

In mammograph-guided biopsy techniques, three primary methods are employed: wire positioning, core needle biopsy (CNB), and vacuum-assisted breast biopsy (VABB). Wire positioning involves inserting a biopsy needle into the suspicious lesion area of the breast under the guidance of mammography. A metal guidewire is then used for indentation positioning to guide surgical resection and histopathological examination. This method is commonly employed for patients with highly suspected malignant lesions identified through mammography (7). CNB utilizes a spring-loaded biopsy gun along with a 14G core needle to execute multiple biopsies directly on suspicious malignant lesions (8). This approach yields an impressive accuracy rate of 79–99% for diagnosing breast diseases (9). Meanwhile, VABB employs a rotary cutting needle with tomographic positioning and negative pressure conditions to perform multiple fan-shaped cuts, ensuring a 360° sample acquisition of the target lesion tissue. This approach ensures an adequate sample size, thereby enhancing the comprehensiveness and reliability of the diagnosis (10).

In recent years, the adoption of DBT has led to a gradual development in the breast biopsy technique guided by tomographic localization. This study aims to introduce the experience of performing biopsies on target lesions identified in mammograms under DBT. It also compares this approach with the traditional prone stereotactic (PS)-guided biopsy method. We present this article in accordance with the STROBE reporting checklist (available at https://qims.amegroups.com/article/view/10.21037/qims-24-2114/rc).

Methods

Clinical data

A retrospective analysis was performed on breast X-ray localization biopsy cases from Shenzhen People’s Hospital, Shenzhen Luohu District People’s Hospital, and Peking University Shenzhen Hospital, covering the period from August 2020 to August 2024. This study included 406 patients with a total of 423 lesions. The inclusion criteria for patients were as follows: diagnosed with Breast Imaging Reporting and Data System (BI-RADS) 4 (including 4A, 4B, 4C) or 5 categories on breast X-ray, necessitating a biopsy; complete clinical, imaging, and pathological data; and no clear contraindications in preoperative examinations. The exclusion criteria encompassed physical constraints preventing patients from lying prone and near the bed surface and lesions located deep within the breast near the pectoralis major muscle or adjacent to the surface of breast implants. All participants were female, aged 23–73 years, with an average age of 46.6±7.5 years. All DBT- and PS-guided biopsies were conducted by a consistent team of eight breast imaging specialists with 15–24 years of extensive experience in biopsy procedures. This level of expertise ensured standardized execution across institutions and minimized procedural variability. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). The study was approved by the Medical Ethics Committee of Shenzhen People’s Hospital (No. LL-KY-2021624) and the requirement for individual consent for this retrospective analysis was waived.

Equipment and procedures

PS-guided biopsy

The PS-guided biopsy utilized the Siemens Mammomat Inspiration X-ray machine (Siemens, Erlangen, Germany) and a stereotactic biopsy system. This method included CNB and wire positioning. For CNB, a TSK Acecut biopsy needle (14G × 75 mm; TSK Laboratory, Tochigi, Japan) was used, whereas a Bard biopsy system needle (20G × 10.7 cm; Bard, Inc., Murray Hill, NJ, USA) was applied for wire positioning. Patients were placed in a prone position, and lesions classified as BI-RADS 4 or 5 with calcifications were selected as targets. Imaging at 0° and ±15° was performed to determine the lesion entry path, with X, Y, and Z-axis coordinates calculated based on the ±15° images (Figure 1). Typically, three exposures were required for imaging: one for the 0° image and two for the ±15° images. Additional exposure may be required during the biopsy process according to the doctor’s needs, such as determining the correct position of the biopsy needle.

Figure 1 The schematic diagrams of metal positioning and CNB positioning in PS-guided biopsy. (A,B) A pair of images for metal positioning was used to locate the lesion in PS-guided. (C-E) The schematic diagrams of 0° and ±15° images for lesion localization during CNB in PS-guided. CNB, core needle biopsy; PS, prone stereotactic.

After assessing the target and biopsy entry path, the skin was disinfected, local anesthesia was administered, and a 14G biopsy needle was inserted for biopsy or wire positioning. For CNB patients, X-ray imaging confirmed the retrieval of target calcification. For patients undergoing wire positioning, surgery was conducted to verify retrieval of the calcifications using X-ray imaging.

DBT-guided biopsy

The DBT-guided biopsy was performed using the Hologic Selenia Dimensions Affirm DBT biopsy system (Hologic, Marlborough, MA, USA). This approach included CNB, wire positioning, and VABB. The biopsy needles utilized were as follows: TSK Acecut biopsy needle (14G × 75 mm) for CNB, Bard biopsy system needle (20G × 10.7 cm) for wire positioning, and EnCor Enspire overview cutting needle [7G; Becton, Dickinson, and Co. (BD), Franklin Lakes, NJ, USA] for VABB.

This method was applied to BI-RADS 4 or 5 lesions, including both calcified and non-calcified types. Patients were positioned prone, and the most distinct imaging plane of the lesion was selected for the biopsy. The system guided the procedure to the biopsy plane, with the processes for CNB and wire positioning following principles similar to stereotactic localization, typically requiring only one exposure. Additional exposure would be conducted during the biopsy process.

For VABB, after confirming the lesion’s localization, the skin was disinfected, local anesthesia was administered, and a small incision was made. The cutting needle was positioned at the target under DBT guidance, and a 360° cutting motion was employed to collect suspicious calcifications. Subsequent X-ray imaging confirmed the retrieval of calcifications, and DBT imaging verified the excision of the lesion at the biopsy plane (Figure 2).

Figure 2 Images before (A) and after (B) biopsy during VABB under DBT-guided biopsy. The red circle marks the position of the most suspicious lesion, while the arrow demonstrates the lesion’s successful extraction following the VABB. DBT, digital breast tomosynthesis; VABB, vacuum-assisted breast biopsy.

Complications

Records were made of any severe pain, bleeding, and self-limiting vasovagal reactions that occurred during or after the biopsy procedure.

Statistical analysis

Data were divided into DBT-guided and PS-guided groups (Figure 3). Statistical analysis was performed using SPSS 27.0 software (IBM Corp., Armonk, NY, USA) to compare the total intervention time, lesion targeting and tissue sampling times, the number of times the first valid localization image was obtained, exposure times, and complications between the two groups. The Kolmogorov-Smirnov test was used to analyze the normality of measurement data. Measurement data that conformed to a normal distribution were represented as mean ± standard deviation, and an independent samples t-test was used to compare the two groups. The measurement data that did not conform to a normal distribution were represented as modify it to median (interquartile range, IQR), and the Mann-Whitney U test was used to compare the two groups. The number of cases represented count data, and the Chi-squared test was used to compare the two groups, with P<0.05 indicating statistical significance.

Figure 3 Flowchart of the study. CNB, core-needle biopsy; DBT, digital breast tomosynthesis; PS, prone stereotactic; VABB, vacuum-assisted breast biopsy.

Results

General patient information

A total of 406 patients was divided into two groups based on the localization method: the DBT-guided group, which included 234 individuals, and the PS-guided group, comprising 172 individuals. According to the classification criteria of the BI-RADS, version 5 of the American College of Radiology (11), there were 234 patients, among whom 214 had dense breast tissue with calcifications as the primary lesion type in the DBT-guided group. Only 20 cases were due to architectural distortion and asymmetry. Pathology results showed 168 cases of benign lesions, accounting for 71.8%; there were 50 cases of malignant lesions, accounting for 21.4%. Additionally, there were 16 cases of high-risk lesions, accounting for 6.8%. The biopsy success rate for the 234 patients was 100% (234/234). Among these patients, 40 underwent surgical treatment, and their postoperative pathology was consistent with the initial biopsy findings. A total of 38 patients remained stable after two years of follow-up, and no progress was observed.

In the PS-guided group of 172 patients, 168 had dense breast tissue. The primary lesion type was calcifications. All lesions were either calcifications or contained calcifications. The pathological results revealed 133 cases of benign lesions, constituting 77.3% of the total; 31 cases of malignant lesions, making up 18%; and 8 cases of high-risk lesions, accounting for 4.7%. The biopsy and sampling success rate for all patients was 100% (172/172) (Table 1). Of these, 46 patients underwent surgical treatment, and the postoperative pathology matched the biopsy results. A total of 32 patients remained stable after two years of follow-up, and no progress was made.

Improved efficiency and safety in comparison with the PS-guided group

In the PS-guided group, target selection had to be re-operated before biopsy when multiple lesions were sampled within the same biopsy window. However, in the DBT-guided group, multiple target lesions could be selected for localization within the same biopsy window without subsequent repeated operations.

In the wire positioning, the DBT-guided group achieved a biopsy success rate of 100% (42/42), whereas the stereotactic-guided group recorded a success rate of 92.6% (63/68). The difference between these two groups was not statistically significant (P=0.154). Compared to the PS-guided group, the DBT-guided group had a shorter total intervention, lesion targeting time, and fewer instances of obtaining the first effective localizing image and exposure (P<0.001). The DBT-guided and PS-guided groups exhibited low complication rates, with no statistically significant difference (P=0.851) (Table 2).

In CNB, the DBT-guided group achieved a guidance success rate of 100% (123/123), whereas the PS-guided group had a success rate of 96.2% (100/104); this difference was not statistically significant (P=0.127). The DBT-guided group exhibited shorter total intervention and lesion targeting time than the PS-guided group. Additionally, there were fewer instances of obtaining the first effective localizing image and exposures in the DBT-guided group, with these differences being statistically significant (P<0.001). The complication rates for the DBT-guided and PS-guided groups were similarly low, with no statistically significant difference (P=0.861) (Table 3).

DBT-guided VABB

A total of 69 patients underwent VABB with DBT guidance, including 15 non-calcified lesions and 54 calcified lesions. Pathology results revealed that there were 28 malignant lesions and 41 benign lesions. The average operation time was 19.49±4.75 minutes, with localization time being 6.00 (5.00, 7.00) minutes, and puncture time averaging 13.45±3.73 minutes. The number of first effective localizing images obtained was 1.00 (1.00, 1.00) per case, with an exposure count of 4.00 (4.00, 5.00). Only two patients reported severe pain following the biopsy, whereas one patient experienced a vasovagal reaction after the procedure.

Compared with the PS-guided group, the localization time for the targeted lesion was significantly shorter in the DBT-guided group, showing a statistically significant difference (P<0.05). Additionally, the localization time for VABB in the DBT group was similar to that of both wire localization and CNB (Figure 4).

Figure 4 Half violin plot localization time (minutes). (A) DBT-guided wire positioning localization time. (B) PS-guided wire positioning localization time. (C) DBT-guided CNB localization time. (D) PS-guided CNB localization time. (E) DBT-guided VABB localization time. Between (A) and (B-D), there is statistically significant difference between them (P<0.05). CNB, core-needle biopsy; DBT, digital breast tomosynthesis; PS, prone stereotactic; VABB, vacuum-assisted breast biopsy.

Discussion

Several researchers (12-14) have investigated the feasibility of needle biopsies guided by DBT. Among these researchers, Vijapura (15) provided an in-depth explanation of the principles underlying biopsies conducted by DBT. He clarified the transition from stereotactic to DBT and highlighted the benefits of using DBT. DBT can improve the visualization of both structural distortions and non-calcified masses, and it can also identify and guide biopsies of suspected malignant non-calcified lesions (16). Nguyen et al. compared the efficiency and outcomes of 1,354 biopsies of suspicious breast calcifications under DM and DBT (17). They concluded that DBT-guided biopsies for suspicious calcifications result in shorter surgical time and lower radiation exposure. However, the study focused solely on calcified lesions and did not analyze non-calcified lesions. In our study, stereotactic-guided biopsies were only performed for calcified lesions, as the masking effect of stereotactic positioning typically precludes its use for non-calcified lesions. This underscores one of the key advantages of DBT, which is its capability to guide biopsies for both calcified and non-calcified lesions. Furthermore, under the guidance of DBT, we achieved successful biopsies in 20 cases of non-calcified lesions. According to related literature reports (18), biopsies performed under DBT have higher success rates and positive predictive values for detecting malignant lesions. In this study, biopsies were performed on a total of 406 patients. Within the DBT-guided group, the success rates for both wire positioning and CNB exceeded those observed in the PS-guided group (100% vs. 92.6%, 100% vs. 96.2%). Given that both methods exhibit high success rates, there is no statistically significant difference between them (P>0.05). In the DBT-guided group, the proportion of malignant biopsy results was 21.4% (50/234), compared to 18.0% (31/172) in the PS group. All of these have postoperative pathological results. The results indicate that the DBT-guided group had a higher successful detection rate for malignant lesions than the PS-guided group (P<0.05). This may be due to DBT reducing tissue overlap, enhancing the detection capability for suspicious malignant lesions.

Schrading et al. (19) compared the surgical time, biopsy time, number of exposures, and complications between 46 cases with DBT-guided and 165 cases with PS-guided VABB. The results showed that DBT guidance had better clinical outcomes than PS guidance, which is consistent with the findings of this study. Our study compared wire positioning and CNB performed under DBT to those conducted under PS. Statistical results revealed that the operation and localization times were significantly shorter in the DBT-guided group than in the PS-guided group. Additionally, the number of exposures required in the DBT-guided group was significantly fewer than that in the PS-guided group (P<0.05). Under DBT, biopsies can be guided by preoperative mammographic images to locate the lesion precisely, and only a single exposure is needed during the biopsy to obtain the first effective localization image. In contrast, biopsies typically require one or more exposures under PS to achieve the first effective localization image. Additionally, DBT provides multi-angle projections and breast reconstruction images that display the target lesion. Biopsies guided by DBT allow for more precise and quicker targeting of lesions. This results in significantly reduced total intervention and lesion targeting time under DBT guidance, along with reduced exposures and minimal attempts required to obtain the first effective localization image. Reducing total intervention time decreases the duration of breast compression during the biopsy process, effectively lowering the risk of tissue movement and patient discomfort during the procedure. Decreasing the number of exposures also reduces the radiation dose received by the patient. Weinfurtner et al. (20) compared upright DBT-guided and PS-guided breast biopsies and found that both methods had similarly low complication rates. The patients in the study underwent biopsies in a prone position. The results showed that both DBT-guided and PS-guided biopsy methods had low complication rates (P<0.05). However, the incidence of self-limiting vasovagal reactions was slightly higher under PS-guided compared to DBT-guided biopsy. This difference may be due to the longer operation time associated with PS-guided procedures, which can induce tension and anxiety, associated with PS-guided procedures.

Studies have shown (10,21,22) that vacuum-assisted excision plays a definitive role in treating benign lesions. This technique can be used for both the excision of benign lesions and the biopsy of architectural distortion. Relevant meta-analyses have demonstrated that vacuum-assisted biopsy can accurately assess lesions detected by mammography, exhibiting high sensitivity and specificity (23). In addition, relevant studies have introduced the feasibility of VABB guided by DBT (24-26); Senapati performed biopsy on 73 cases of non-calcified lesions, and the results showed that it has high accuracy for non-calcified lesions (25). In this study, a total of 69 patients underwent DBT-guided VABB. Among these patients, 16 had non-calcified lesions. The pathology results revealed that 38 cases (55.1%) were benign, 6 cases (8.7%) were classified as high-risk lesions, and 25 cases (36.2%) were malignant. Additionally, 10 cases underwent postoperative histopathological examination, the results of all of which were consistent with the initial biopsy pathology findings. In the study by Bahl et al. (27), the effectiveness of vacuum-assisted excision under DBT guidance was compared with that under PS guidance. The findings showed that using VABB under DBT guidance led to a significantly higher success rate than that under PS guidance. Additionally, it required less total intervention time and resulted in reduced radiation exposure compared to PS guidance. However, due to the limited number of cases involving VABB under PS-guided in this study, we did not conduct a comparative analysis between DBT and PS guidance. Instead, we compared VABB with wire positioning and CNB under DBT guidance. We found that VABB is simpler to perform. Additionally, its lesion targeting and tissue sampling time are similar to or even shorter than those of wire positioning and CNB. Performing VABB under DBT guidance provides a superior method selection in clinical practice and offers enhanced guidance to clinicians in treatment planning.

The limitations of this study are mainly reflected in the following aspects. First, due to the lack of VABB cases under PS guidance, we could not perform an in-depth comparative analysis between the effects of VABB under DBT and PS guidance. Second, we did not collect specific information about radiation doses. Therefore, we used the number of exposures as a surrogate indicator for radiation dose assessment. Third, some patients had short follow-up times, and we have not yet received their final postoperative pathology results. This limits our ability to explore the impact of different puncture methods on the pathological upstaging rate of breast lesions.

Conclusions

Compared with PS-guided biopsy, DBT-guided biopsy offers distinct clinical advantages by effectively mitigating masking effects, enabling the detection of both calcified and non-calcified lesions. Additionally, the ease of DBT localization significantly shortens procedure time and reduces imaging exposures, enhancing overall clinical efficiency.

Acknowledgments

The authors would like to thank Medjaden Inc. for English language editing and review services and all those involved in the study for dedicating their time and skills to the completion of this study.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://qims.amegroups.com/article/view/10.21037/qims-24-2114/rc

Funding: This paper was supported by the Shenzhen Science and Technology Research and Development Fund (No. GJHZ20220913142613025), which was critical to the successful completion of this study.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://qims.amegroups.com/article/view/10.21037/qims-24-2114/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). The study was approved by the Medical Ethics Committee of Shenzhen People’s Hospital (No. LL-KY-2021624) and the requirement for individual consent for this retrospective analysis was waived.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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