Vacuum-assisted excision versus open surgery for intraductal lesions: a systematic review and meta-analysis of therapeutic effectiveness, safety, and patient-reported outcomes

Introduction

Intraductal lesions represent a common spectrum of pathologies in breast surgery, encompassing a range of pathological entities from benign intraductal papillomas to ductal carcinoma in situ (DCIS) (1). In clinical practice, intraductal breast lesions are typically first stratified by risk using imaging, such as ultrasonography, mammography, or magnetic resonance imaging (MRI), followed by core needle biopsy (CNB) or stereotactic vacuum-assisted biopsy to establish the pathological diagnosis. On this basis, vacuum-assisted excision (VAE) or open surgical excision is subsequently employed primarily as a therapeutic intervention (2). Traditional open surgical procedures, such as lobectomy or segmental resection, achieve en bloc excision of the lesion with a margin of surrounding normal tissue under direct visualisation through a skin incision and have long been widely applied in breast surgery because of their well-defined resection margins and established oncologic safety. However, the relatively large incision, prolonged recovery period, and potential adverse effects on breast cosmesis have driven the development of minimally invasive approaches. Vacuum-assisted breast biopsy (VABB) is a minimally invasive technique that uses vacuum suction and a rotary cutting device to excise lesions in a piecemeal manner under ultrasound or stereotactic guidance. It has been increasingly adopted in recent years owing to its minimal tissue trauma, rapid recovery, and favourable cosmetic outcomes (3).

Contemporary comparative studies of VAE versus open surgery primarily focus on hard endpoints, such as complication rates, margin status, and recurrence rates. With the paradigm of patient-centred care garnering increasing prominence in contemporary clinical practice, postoperative experiences, cosmetic satisfaction, psychological well-being, and quality of life have become essential parts of comprehensive surgical assessment (4). The global academic community is becoming increasingly aware of the critical role of patient-reported outcomes (PROs) in assessing therapies (5), delivering crucial insights beyond traditional clinical metrics.

Therefore, this study developed a three-dimensional (3D) evaluation model that integrates oncological effectiveness, perioperative safety, and PROs to systematically compare overall outcomes of VAE versus open surgery (lobectomy/segmentectomy). Through systematic synthesis and rigorous analysis of the latest clinical evidence, we sought to develop a more scientific assessment framework, thereby providing high-level evidence to advance patient-value-centred, individualised surgical decision-making. We present this article in accordance with the PRISMA reporting checklist (available at https://gs.amegroups.com/article/view/10.21037/gs-2026-1-0010/rc).

Methods

Search strategy

Electronic databases, including PubMed, Embase, CNKI, and Wanfang Data, were systematically searched for records published between January 2015 and October 2025. Search terms included: “Vacuum-Assisted Breast Biopsy”, “Breast Lobectomy” or “Segmentectomy”, “Intraductal Papilloma” or “Intraductal Lesion”, and “Patient-Reported Outcomes”, or “Quality of Life”, or “Cosmetic Satisfaction”. A comprehensive search strategy was developed using database-specific subject headings, supplemented by manual screening of the reference lists from included articles. Initially, no language restrictions were applied during the initial literature search. However, in the later screening and eligibility assessment, inclusion was strictly limited to full-text articles published in either Chinese or English. To ensure reproducibility, the detailed search strategies for all electronic databases are documented in Appendix 1.

Study selection

Literature screening and data extraction were performed independently by two investigators (Figure 1), and the methodological quality of the included observational cohort studies was evaluated using the Newcastle-Ottawa Scale (NOS). Any disagreements were resolved through discussion or adjudication by a third-party reviewer. Eligible study designs included randomised controlled trials (RCTs), cohort studies, and case-control studies. Notably, after full-text screening and excluding single-arm reports, all studies that met the criteria for quantitative comparison were identified as retrospective cohort studies directly comparing VAE with open surgery (including lobectomy, segmentectomy, etc.) for the treatment of intraductal lesions. The “open surgery” cohort included traditional procedures such as lobectomy, segmentectomy, and microdochectomy, performed mainly for therapeutic reasons. Consistency in surgical scope and purpose (diagnostic versus therapeutic) was strictly maintained across all included studies, requiring complete lesion removal as the definitive treatment goal. Regarding the study population, inclusion required preoperative assessment by imaging methods combined with CNB to identify benign or high-risk intraductal lesions. Cases with a confirmed preoperative diagnosis of invasive breast carcinoma or those requiring management according to established malignant oncological protocols were excluded. As a result, this study does not compare VAE and open surgery as competing options for treating malignancy; instead, it investigates outcomes associated with different management approaches within a clinical setting where preoperative malignancy diagnosis is lacking. Because of the limited number of direct comparative studies focused solely on intraductal lesions, data involving benign breast masses were included as supplementary evidence to comprehensively assess perioperative safety and PROs. Interpretations of relevant oncological outcomes are strictly confined to the clinical setting of populations with intraductal or preoperative low- or high-risk lesions. Case reports, reviews, studies with incomplete data, and non-Chinese/English publications were excluded. The review was not prospectively registered; however, the study protocol was established a priori and strictly adhered to throughout the review process to minimise the risk of selective reporting. As this study was a meta-analysis of previously published data, informed consent was not required, and ethical approval was waived. To reduce heterogeneity in PROs, strict data-extraction criteria were applied. For postoperative pain, priority was given to Visual Analogue Scale (VAS) scores recorded 6 hours after the procedure, recognising this as the standard time frame for assessing acute pain. Regarding cosmetic outcomes, “satisfaction” was defined as a subjective patient score of 90% or higher or a qualitative rating of “excellent” or “good” to ensure comparability across studies.

Figure 1 Study identification and selection.

Statistical analysis

A total of 26 studies were ultimately included in the analysis. To comprehensively evaluate the clinical effectiveness of both surgical approaches, dual primary endpoints were established to clearly address oncological safety and patient-centred outcomes. Primary endpoint I (oncological safety): postoperative recurrence rates were analysed to determine whether VAE is not inferior to open surgery in achieving local disease control. Primary endpoint II (patient-centred measures): PROs, specifically cosmetic satisfaction and postoperative pain scores, along with overall complication rates (including hematoma and infection), were assessed to demonstrate the superiority of minimally invasive techniques in enhancing quality of life and reducing surgical trauma. Secondary outcomes included operative duration, intraoperative blood loss, and residual lesion rates. Data analysis was performed using RevMan software (version 5.4.1). A random-effects model was employed for meta-analysis of suitable data, with risk ratios (RR) calculated for dichotomous variables and mean differences (MD) for continuous variables, each reported with 95% confidence intervals (CI). Heterogeneity: The I² statistic was used to measure heterogeneity; notably, for outcomes with significant heterogeneity (I²≥75), sensitivity analyses were conducted using a leave-one-out approach. At the same time, to better understand potential effect modifiers, subgroup analyses were conducted, stratified by covariates such as lesion size, imaging-guidance modality, and Breast Imaging Reporting and Data System (BI-RADS) classification. To clarify the potential impact of population heterogeneity on primary oncological outcomes, subgroup analyses were stratified by study population, categorising cohorts into “pure intraductal lesions” and “mixed benign lesions”, and the results of subgroup tests were explicitly reported. Furthermore, sensitivity analyses focusing on recurrence outcomes were conducted by restricting inclusion to studies of pure intraductal lesions, thereby validating the robustness of the pooled effect direction. A descriptive synthesis was conducted for data unsuitable for pooling. Publication bias was assessed using funnel plots for outcome measures with more than 5 studies.

Results

The detailed characteristics of the 26 retrospective cohort studies included in this review are summarised in Table 1. Overall, the methodological quality of the included studies was moderate to high. Specifically, 18 studies (69.2%) were rated as high quality (NOS score ≥7 stars), 6 studies (23.1%) as moderate quality (NOS score 5–6 stars), and only 2 studies (7.7%) as low quality (NOS score <5 stars). Notably, over 60% of the studies received a star in the critical “comparability of cohorts” domain for controlling key confounders, such as age and lesion size. These quality assessment results indicate that the evidence base synthesised in this systematic review is generally robust. Although 26 comparative studies were included, there was significant heterogeneity in the reporting of outcomes across datasets. As a result, the number of studies used in specific meta-analyses ranged from 4 to 7, depending solely on the availability of extractable data for each study endpoint.

Dimension 1: oncological efficacy

The definition of recurrence outcomes was strictly based on the reporting standards established in the primary studies. Mainly, recurrence was defined as the radiological or clinical reappearance of lesions during follow-up, with no clear distinction between benign regrowth and malignant relapse. A meta-analysis assessing recurrence rates was performed using data from eligible comparative studies (6,7,10,20) (Figure 2). The pooled analysis demonstrated that VAE was associated with a significantly reduced risk of recurrence compared to open surgery (RR =0.43; 95% CI: 0.21–0.86; P=0.02). Notably, no significant statistical heterogeneity was observed across the included studies (I²=0%; P for heterogeneity =0.67). To evaluate the potential impact of population heterogeneity on primary oncological outcomes, subgroup analyses were stratified by cohort composition, categorizing studies into “pure intraductal lesions” and “mixed benign lesions”. Tests for subgroup differences revealed no statistically significant interaction (P=0.24 for heterogeneity), indicating that population differences did not significantly alter the overall treatment effect’s direction. Notably, a reduction in recurrence risk associated with VAE was consistently observed within the pure intraductal lesion subgroup. Furthermore, sensitivity analyses limited to studies examining pure intraductal lesions confirmed that the overall effect’s direction remained consistent. While the statistically significant reduction in recurrence rates linked to VAE is notable, these findings should be interpreted with caution. Clinically, VAE is mainly used for smaller, solitary lesions, while open excision (e.g., lobectomy) is often reserved for larger, multifocal, or architecturally complex pathologies. As a result, the difference in recurrence outcomes may largely be due to inherent selection bias based on baseline lesion characteristics, rather than the intrinsic technical superiority of the VAE procedure.

Figure 2 Forest plot: recurrence rates. CI, confidence interval; df, degree of freedom; M-H, Mantel-Haenszel; VAE, vacuum-assisted excision.

A pooled analysis of the residual lesion rates reported across four studies (9,12-14) revealed no statistically significant difference in residual lesion risk between the VAE and open surgery groups (RR =1.02; 95% CI: 0.29–3.57; P=0.97) (Figure 3). The RR point estimate of 1.02 suggests that the risks are nearly equivalent between the two interventions. Importantly, no heterogeneity was detected across these studies (I²=0%), strengthening the consistency and reliability of this finding.

Figure 3 Forest plot: residual lesion rates. CI, confidence interval; df, degree of freedom; M-H, Mantel-Haenszel; VAE, vacuum-assisted excision.

Given the pronounced clinical heterogeneity among the included studies regarding patient selection criteria, radiologic stratification, and baseline malignancy risk, we deliberately avoided conducting a quantitative meta-analysis of malignancy detection rates to prevent misleading conclusions. Instead, a descriptive synthesis showed that, among studies reporting postoperative pathological upstaging, the median malignancy detection rate was generally higher in the open surgery group (median: 9.67%) than in the VAE group (median: 3.39%) (19). Notably, this numerical discrepancy should not be construed as a definitive difference in diagnostic efficacy between the two modalities but likely reflects an intrinsic selection bias prevalent in retrospective cohorts. Specifically, lesions characterised by high radiologic suspicion (e.g., BI-RADS 4B/5) or overt clinical symptoms were preferentially referred for open surgical excision to achieve broader margins. Conversely, VAE was predominantly utilised for lesions with imaging features suggestive of benignancy (e.g., BI-RADS 3/4A). Consequently, these findings are presented descriptively, and no definitive inferences regarding the diagnostic superiority or oncological safety of either surgical approach are posited.

Dimension 2: post-procedural complications

Five studies, encompassing 503 patients, reported the incidence of postoperative ecchymosis (6,7,11,15,21). Meta-analysis (Figure 4) demonstrated that VAE significantly reduced the risk of postoperative ecchymosis by 57% compared to open surgery (RR =0.43; 95% CI: 0.20–0.95; P=0.04), indicating statistical significance and clinical importance. Notably, no heterogeneity was detected among the studies (I²=0%), suggesting that the protective effect of VAE is consistent and robust across different surgical settings and patient populations. This finding strongly supports the superior perioperative safety profile of VAE in terms of reduced tissue trauma and minor hemorrhagic complications.

Figure 4 Forest plot: postoperative ecchymosis rates. CI, confidence interval; df, degree of freedom; M-H, Mantel-Haenszel; VAE, vacuum-assisted excision.

In contrast to the definitive advantage of VAE in reducing ecchymosis, its impact on postoperative hematoma incidence was evaluated across six studies (6,7,11,15,16,22) involving 610 patients (Figure 5). Meta-analysis revealed no statistically significant difference in hematoma risk between the VAE and open surgery groups (RR =0.94; 95% CI: 0.42–2.10; P=0.88). The RR point estimate of 0.94 indicates nearly equivalent risks between the two surgical approaches. Low to moderate heterogeneity was observed among the studies (I²=32%). Based on the available evidence, no statistically significant difference in hematoma incidence was observed between VAE and open surgery. The funnel plot for this outcome (Figure 6) demonstrated an asymmetric distribution, indicating potential publication bias.

Figure 5 Forest plot: hematoma rates. CI, confidence interval; df, degree of freedom; M-H, Mantel-Haenszel; VAE, vacuum-assisted excision.

Figure 6 Funnel plot: hematoma rates. RR, risk ratio; SE, standard error.

Five studies reporting surgical site infections were included in the meta-analysis (6,7,15,16,22) (Figure 7). The pooled results demonstrated that VAE was associated with a statistically significant 69% reduction in infection risk compared to open surgery (RR =0.31; 95% CI: 0.14–0.69; P=0.004). The test for overall effect reached high significance (Z=2.87). Furthermore, no heterogeneity was detected among the included studies (I²=0%), indicating that the protective effect of VAE is consistent and reliable across diverse clinical settings. This finding underscores a key perioperative safety advantage of the minimally invasive VAE technique, likely attributable to its smaller incision and reduced risk of pathogen exposure.

Figure 7 Forest plot: incisional wound infection rates. CI, confidence interval; df, degree of freedom; M-H, Mantel-Haenszel; VAE, vacuum-assisted excision.

The impact of surgical approach on breast cosmesis was evaluated by analyzing the incidence of local depression or deformity. A meta-analysis of four studies (8,17,19,23) involving 564 patients showed results strongly and significantly favoring VAE (Figure 8). Compared with open surgery, VAE use was associated with a pronounced 81% reduction in the risk of postoperative breast deformity (RR =0.19; 95% CI: 0.05–0.74; P=0.02). This protective effect was consistent across studies, with no heterogeneity detected (I²=0%). This finding provides the most direct objective evidence of VAE’s superior cosmetic outcomes, as the technique preserves native breast architecture through minimal tissue disruption, thereby maintaining the natural breast contour.

Figure 8 Forest plot: breast depression rates. CI, confidence interval; df, degree of freedom; M-H, Mantel-Haenszel; VAE, vacuum-assisted excision.

The operative time was significantly shorter in the VAE group compared to the open surgery group. A meta-analysis of five studies (22,24-26,29) (Figure 9) demonstrated that VAE significantly reduced operative time by a pooled MD of −14.38 minutes (95% CI: −17.09 to −11.67; P<0.001). This reduction represents an approximate 44% decrease relative to the mean operative time in the open surgery group. Despite substantial statistical heterogeneity (I²=94%), potentially attributable to inter-center variations in surgeon proficiency, lesion complexity, and specific procedural protocols, the direction of effect consistently favored VAE across all individual studies. This finding indicates superior procedural efficiency for VAE, contributing to reduced patient exposure to anesthesia and improved operating room turnover.

Figure 9 Forest plot: operation time. CI, confidence interval; df, degree of freedom; IV, inverse variance; SD, standard deviation; VAE, vacuum-assisted excision.

Meta-analysis of intraoperative blood loss across these studies (24,25,30) revealed a statistically significant and clinically relevant reduction in the VAE group (Figure 10). The pooled MD was −9.10 mL (95% CI: −11.29 to −6.92; P<0.001), indicating significantly less blood loss with VAE compared to open surgery. This represents an approximate 46% reduction relative to the mean blood loss in the open surgery group. Substantial statistical heterogeneity was observed across studies (I²=93%), likely reflecting variations in surgical technique, lesion vascularity, and methods for measuring blood loss. Despite this variability, the direction of effect consistently favored VAE across all analyses. This marked reduction in blood loss directly reflects VAE’s minimally invasive nature and contributes to its superior perioperative safety profile.

Figure 10 Forest plot: intraoperative blood loss. CI, confidence interval; df, degree of freedom; IV, inverse variance; SD, standard deviation; VAE, vacuum-assisted excision.

Dimension 3: PROs

A pooled analysis of patient-reported cosmetic satisfaction (defined as high satisfaction scores, e.g., ≥90%) was conducted across seven studies (18,20,24-28) (Figure 11). The meta-analysis demonstrated a statistically significant and consistent advantage for VAE. Patients undergoing VAE were 34% more likely to report high cosmetic satisfaction than those undergoing open surgery (RR =1.34; 95% CI: 1.15–1.56; P<0.001). The test for overall effect demonstrated high significance (Z=3.70). The complete absence of heterogeneity (I²=0%) indicates that the superiority of VAE in cosmetic outcomes is a robust finding consistently observed across all included studies. This finding provides direct quantitative evidence that the minimally invasive nature of VAE translates into clinically meaningful benefits that are both perceptible and highly valued by patients. The funnel plot for this outcome (Figure 12) exhibited asymmetry, suggesting potential publication bias.

Figure 11 Forest plot: patient-reported cosmetic satisfaction. CI, confidence interval; df, degree of freedom; M-H, Mantel-Haenszel; VAE, vacuum-assisted excision.

Figure 12 Funnel plot: patient-reported cosmetic satisfaction. RR, risk ratio; SE, standard error.

Postoperative pain, assessed using the VAS, was analysed across four studies (21,22,30,31) (Figure 13). Meta-analysis demonstrated a statistically significant reduction in pain levels for the VAE group compared to the open surgery group, with a pooled MD in VAS scores of −1.61 points (95% CI: −2.68 to −0.54; P=0.003). It must be noted that considerable statistical heterogeneity was observed among the included studies (I²=99%). This substantial variability likely stems from differences in perioperative analgesic protocols, surgical volume, and patient-specific pain thresholds across studies. Despite this heterogeneity, the forest plot revealed that the effect estimates from all studies consistently favoured VAE, with three of the four studies achieving statistical significance. This consistent direction of effect robustly confirms that VAE provides a clinically meaningful advantage in reducing postoperative pain, a key determinant of early recovery and patient experience.

Figure 13 Forest plot: VAS. CI, confidence interval; IV, inverse variance; SD, standard deviation; VAE, vacuum-assisted excision; VAS, Visual Analogue Scale.

Given the substantial heterogeneity in PRO assessment instruments and temporal evaluation points across the included studies, a supplementary narrative synthesis was conducted to assess the robustness of the findings. The temporal evaluation points for postoperative pain were predominantly concentrated within the acute postoperative phase. Specifically, these studies (21,30,31) documented immediate postoperative VAS scores (0–6 hours), reflecting the acute nociceptive response following anaesthesia subsidence, whereas one study (22) reported pain metrics at 24 hours postoperatively. Despite temporal variations in assessment windows, the directionality of the effect remained highly consistent across all studies: pain scores in the VAE cohort were significantly lower than those in the open surgery group (MD range, −3.05 to −0.22), demonstrating the superior analgesic efficacy of VAE throughout the early postoperative period. The assessment instruments used to measure cosmetic satisfaction showed substantial diversity. Some studies used simplified binary questionnaires (satisfied vs. unsatisfied), while others used more granular four-point grading scales (excellent/good/fair/poor). To standardise outcome reporting, data representing the highest tier of evaluation (“satisfied” or “excellent/good”) were extracted from each respective scale. Results indicated that, regardless of the scoring instrument used, the proportion of high satisfaction was significantly higher in the VAE cohort than in the open surgery group. Consequently, notwithstanding the aforementioned methodological heterogeneity, the clinical superiority of VAE in enhancing patient subjective experience was corroborated across distinct measurement dimensions and temporal points.

Substantial heterogeneity (I²≥75) was observed across the outcomes of postoperative pain scores, intraoperative blood loss, and operative duration. To assess the robustness of these findings, sensitivity analyses using a leave-one-out approach were performed for each outcome. The results demonstrated that the overall direction of the pooled effect remained consistent after excluding any single study, confirming the stability of the results. Visual Inspection of the funnel plots showed asymmetry, suggesting potential publication bias, in which the non-publication of smaller retrospective cohorts may have led to an overestimation of the pooled effect sizes. Notably, in meta-analyses with fewer than 10 studies, interpreting funnel plot asymmetry is inherently limited by low statistical power. Therefore, although the results indicate a significant advantage of VAE across various perioperative outcomes, these findings should be viewed with caution due to the possible impact of publication bias on the validity of the conclusions. Future studies should focus on larger sample sizes to enhance the statistical power and reliability of the results.

Discussion

This study developed a 3D evaluation model that combines oncological effectiveness, perioperative safety, and PROs to compare VAE and open surgery thoroughly. The synthesised evidence outlines complementary roles for both techniques: VAE demonstrates superiority in minimally invasive features, cosmetic results, and patient experience, while open surgery remains essential for managing complex or high-risk lesions with its therapeutic completeness.

Regarding oncological efficacy, the finding that the recurrence rate was significantly lower in the VAE group than in the excision group (RR =0.43) should be interpreted with caution. Given the predominance of observational designs and the way “recurrence” is operationalized as either radiological or clinical lesion re-emergence rather than strictly malignant relapse, these findings should not be simplistically interpreted as definitive evidence of superior oncological safety. Notably, clinicians tended to select VAE for smaller lesions with imaging features suggestive of benignity, whereas open surgery was more frequently performed for larger, multifocal, or anatomically complex lesions, potentially introducing selection bias. Therefore, the lower recurrence rate observed in the VAE group may be partly attributable to the inherently lower recurrence risk of the treated lesions, reflecting differences in case selection rather than the technical superiority of the procedure alone. The comparable residual lesion rates between techniques may be attributed to secondary tissue damage from pursuing negative margins in open surgery, combined with variations in pathological assessment. Compared with surgical excision, VAE is an image-guided, minimally invasive procedure primarily used for breast lesions with low-risk imaging features; because lesions are removed piecemeal, systematic oncologic margin assessment is generally not feasible. In contrast, conventional surgical excision allows en bloc resection with formal margin evaluation and therefore retains an irreplaceable oncologic role in the treatment of malignant breast lesions. However, evidence regarding malignancy detection rates remains notably limited. Due to the lack of direct comparative data, a quantitative synthesis of this outcome was not conducted. Additionally, the significant variation in reported malignancy rates across studies is mainly due to differences in baseline risk stratification and clinical indications. Clinically, VAE is preferred for lesions with low-risk radiographic features, while open excision is often used for pathologies with higher suspicion or architectural complexity. As a result, differences in malignancy detection rates across studies likely reflect variations in case composition rather than the inherent diagnostic superiority of either method. Therefore, malignancy detection rates in this study should not be viewed as evidence of a comparative oncological advantage. While this study aimed to evaluate the efficacy and safety of VAE versus open surgery, a quantitative meta-analysis of pathological upgrading—specifically from benign to malignant or from DCIS to invasive carcinoma—was not possible because most included studies did not report these data. Future research should focus on clarifying pathological progression by providing detailed case data to thoroughly assess how different treatment approaches affect lesion outcomes evolution. It must be emphasised that the oncological conclusions of this study primarily apply to populations with lesions that were preoperatively assessed as benign, high-risk, or low-risk intraductal pathologies. Including selected studies involving benign breast masses was intended solely to supplement evidence regarding perioperative safety and PROs, not to support comparative analyses of malignant treatment strategies. Therefore, these findings should not be generalised to guide management recommendations for all breast lesions or confirmed malignancies. Traditional open excision retains a pivotal role in the management of lesions with a high preoperative suspicion of malignancy, particularly when comprehensive margin assessment and en bloc resection are mandated to ensure oncological safety. Notably, a systematic quantitative analysis of postoperative pathological upstaging or reoperation rates could not be conducted in the current study. This was due to inconsistent reporting of relevant data across primary studies, which prevented a valid quantitative synthesis. Recognising that re-intervention imposes a significant therapeutic burden, future research should focus on standardising the reporting of this important outcome.

The perioperative safety profile clearly delineates the value proposition and limitations of VAE as a minimally invasive technique. Its comprehensive advantages—including reduced operative time, less blood loss, lower rates of ecchymosis, wound infection, and breast deformity—substantiate its core benefits in minimising tissue trauma and facilitating accelerated recovery. However, VAE’s failure to reduce the risk of postoperative hematoma (RR =0.94) is a critical finding, highlighting the inherent limitations of its “blind” operational nature. This indicates that minimally invasive does not equate to risk-free, as the potential for deep vascular injury may offset the benefits of a smaller incision (32). Consequently, strict adherence to indications, proficient ultrasonographic skills, and standardised postoperative compression are essential when employing VAE to mitigate such risks. Notably, most included studies reported hematoma or ecchymosis as binary outcomes, without further quantification of their extent, severity, or duration. Therefore, although no statistically significant difference in hematoma incidence was observed between the two surgical approaches, this finding does not imply equivalence in clinical manifestations or patient-reported experience. Particularly in open surgery, the relatively larger operative field may result in postoperative ecchymosis involving a larger area of tissue, a difference that has not yet been systematically evaluated in the existing literature.

Perhaps the most insightful findings of this study emerge from the PROs dimension (33). The significant benefits of VAE in cosmetic satisfaction (RR =1.34) and pain management (MD =−1.61) demonstrate its value extends beyond biological effectiveness to psychosocial aspects. The significantly lower objective breast depression rates (RR =0.19) and improved subjective cosmetic satisfaction mutually support that VAE’s minimally invasive benefits effectively lead to noticeable quality-of-life enhancements. In modern breast surgical practice, PROs should be considered equally crucial as oncological efficacy in core decision-making (34). The 3D evaluation model confirms that VAE offers significant advantages in patient-prioritised areas, including cosmetic outcomes, pain relief, and mental well-being. For patients who value quality of life and breast appearance, VAE remains an excellent option when the residual risk is comparable to open surgery, as long as improved postoperative monitoring is used. Simultaneously, comprehensive evidence analysis indicates that a surgical approach requires integrated judgment, given that intraductal papillomas are the most common type of intraductal lesion. They have a subtle onset, nonspecific clinical signs, and carry a risk of atypical hyperplasia or malignant transformation (approximately 4.4–11.0%). Clinicians should thoroughly communicate the risk-benefit profiles of both procedures and implement individualised decision-making that incorporates lesion characteristics and patient preferences.

This study confirms that no universally “optimal” surgical approach exists; instead, selection should be refined based on a 3D evaluation model that integrates lesion characteristics and patient values. Based on the evidence, we propose an individualised decision-making framework (Figure 14): for solitary lesions smaller than 3 cm on ultrasound and assessed as having a relatively low risk of malignancy, VAE may be considered a preferred management option, particularly in patients—especially younger women—who place greater emphasis on quality of life and cosmetic outcomes. In contrast, for multifocal, diffuse lesions or those associated with high-risk pathological features, open surgery remains indispensable for diagnostic completeness and oncological safety. The borderline lesion is characterised by cases showing clinico-pathological mismatch or high-risk histological subtypes, such as atypical hyperplasia or pre-invasive breast lesions. The management of these cases should go beyond standard protocols, requiring individualised evaluation through multidisciplinary team (MDT) consultation, supported by advanced imaging techniques, like MRI, when necessary. Personalised treatment plans should be developed through shared clinical decision-making, with full disclosure of potential oncological risks and expected cosmetic benefits to the patient. It should be emphasised that the lesion size threshold (≤3 cm) and the imaging-based assessment of “likely benign” described in the manuscript are derived primarily from prior studies and commonly accepted clinical practice, rather than constituting absolute indications. Specifically, “likely benign” generally indicates concordance between imaging findings and pathological results, with lesions predominantly classified as BI-RADS categories 3–4A. This criterion is intended solely as a reference for clinical decision-making. The decision-making framework presented in this study serves as a hypothesis-generating tool to guide future research and pinpoint key factors in therapeutic decisions. It is clearly stated that this framework should not be directly applied to alter current clinical practice; rather, it functions as a reference for assessing clinico-pathological concordance, supporting multidisciplinary consultations, and managing histological atypia. Importantly, in cases of clinico-pathological discordance, this framework provides a multidimensional evidence base to assist clinicians in developing comprehensive management strategies within the context of MDT discussions.

Figure 14 Proposed clinical decision-making framework for the management of breast lesions based on current evidence. BI-RADS, Breast Imaging Reporting and Data System; MRI, magnetic resonance imaging; VABB, vacuum-assisted breast biopsy; VAE, vacuum-assisted excision.

In cases where postoperative pathology after VAE reveals malignancy, subsequent management strategies remain highly controversial. To date, high-quality evidence is lacking to support omitting additional surgical excision when imaging suggests complete lesion removal. For selected patient subgroups considered to have low oncologic risk, or for those who refuse or are unfit for open surgery, whether VAE could serve as a local control strategy under strict selection criteria and be complemented by adjuvant radiotherapy to compensate for limited margin assessment remains to be validated in rigorously designed prospective clinical trials. Such studies are required to delineate the appropriate boundaries of VAE in the detection and subsequent management of malignant lesions, as well as to explore adjunctive strategies integrating imaging, pathology, and molecular subtyping. Accordingly, the decision framework (Figure 14) proposed in this study also delineates an approach to assist risk stratification and subsequent clinical decision-making when malignancy is identified after VAE. Moreover, in clinical practice, VAE is more appropriately positioned as a component of a multimodal diagnostic and therapeutic pathway—in conjunction with imaging evaluation, CNB, and multidisciplinary discussion—rather than as an independent or alternative definitive treatment, to optimise patient selection and mitigate the risk of missed malignancy.

Several limitations of this study warrant acknowledgement. First, regarding the study design, although this systematic review strictly followed the PRISMA 2020 guidelines for literature screening and appraisal, the exclusive inclusion of observational studies introduces inherent confounding factors, such as selection bias, which may affect the accuracy of the findings. Second, concerning the robustness of outcomes, certain pivotal metrics—notably malignancy detection rates—were limited to descriptive analysis due to the paucity of primary data, resulting in a relatively low certainty of evidence. Moreover, significant heterogeneity was observed in the assessment tools, the timing of evaluations, and the standards for measuring PROs. Although bias was reduced by focusing on data from the acute phase and standardising satisfaction criteria, the numerical outcomes—particularly aesthetic evaluations and VAS scores—should be seen as indicating general trends in clinical benefit rather than precise values. Additionally, regarding statistical and clinical heterogeneity, significant variance in certain outcomes (I²≥75%) was observed; although sensitivity analyses confirmed the stability of the overall effect, these results should be interpreted with caution. Due to a lack of detailed information in the primary literature, further investigation of the sources of heterogeneity through subgroup analysis was not possible. Funnel plot analyses indicated potential publication bias for certain indicators, such as cosmetic satisfaction, which, combined with the limited number of studies in select analyses (n<10), may have constrained the overall statistical power. Notably, the extensive time span of the included literature [2016–2025] captures a significant shift in clinical guidelines, with the management of asymptomatic lesions without atypia (e.g., papillomas) moving from active excision to surveillance; this change over time in clinical indications may introduce hidden clinical heterogeneity. Finally, the management and decision-making framework proposed in this study is intended as a clinical reference rather than a substitute for established oncological standards of care. For borderline lesions characterised by clinico-pathological discordance or atypia, clinical decisions must remain contingent upon MDT deliberations and individualised assessment; the broad clinical applicability of this framework necessitates further validation through high-quality, prospective investigations.

Conclusions

Utilising a 3D evaluation framework encompassing oncological efficacy, perioperative safety, and PROs, this systematic review demonstrates that VAE and open surgery (adenectomy/segmentectomy) constitute complementary therapeutic strategies for managing intraductal lesions.VAE exhibits notable advantages in minimal invasiveness, faster recovery, and cosmetic satisfaction, making it the preferred choice for radiologically localised lesions in patients with high aesthetic standards. However, the observed reduction in recurrence risk associated with VAE mostly results from inherent selection bias toward smaller, solitary, and low-risk lesions in retrospective studies, calling for cautious interpretation of these results. It must be underscored that existing evidence remains insufficient to support VAE as a definitive curative intervention for malignant or high-risk intraductal pathologies. Open surgery continues to play an essential role in ensuring complete margin negativity and reliable detection of malignancy; ultimately, the clinical consequences of missing a malignancy far outweigh the minor benefits in cosmetic outcomes. Future clinical practice should transcend the binary selection of surgical techniques, shifting toward an individualised decision-making paradigm that harmonises lesional biological characteristics, objective risk profiles, and subjective patient values.

Acknowledgments

We gratefully acknowledge the support provided by the Department of Breast Surgery, Liaoning Provincial People’s Hospital.

Footnote

Reporting Checklist: The authors have completed the PRISMA reporting checklist. Available at https://gs.amegroups.com/article/view/10.21037/gs-2026-1-0010/rc

Peer Review File: Available at https://gs.amegroups.com/article/view/10.21037/gs-2026-1-0010/prf

Funding: This work was supported by the Basic Research Program of the Department of Science and Technology of Liaoning Province (grant No. 2022020247-JH2/1013); and 2023 Joint Funds Project of the Department of Science and Technology of Liaoning Province-Doctoral Scientific Research Initiation Project (grant No. 2023-BSBA-181).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://gs.amegroups.com/article/view/10.21037/gs-2026-1-0010/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.

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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